Onward Medical N.V.

Annual Report

2025

ONWARD

Medical Annual Report 2025

Message from the

Chairman & CEO

ONWARD at a Glance

2025 Highlights

2026 Outlook

Business Review

Overview

Table of Contents

Culture

Privacy & Data Governance

Sustainability

Operational Review

103

Financial Review

111

Governance

119

Risk Management

& Control

141

Investor Relations

187

Report of the Non-Executive

Directors

193

In this Annual Report, ‘ONWARD’, ‘the Company’, ‘the Group’,

‘we’, ‘us’ and ‘our’ are used interchangeably to refer to ONWARD

Medical N.V. and/or any of its subsidiaries, in general or where

no useful purpose is served by identifying the particular

company. ONWARD, ARC

, ARC

BCI

, and the stylized

O-Logo are proprietary and registered trademarks of ONWARD

Medical. Unauthorized use is strictly prohibited.

Board of Directors’

Statements

203

Remuneration Report

209

Consolidated Financial

Statements

227

Notes to the Consolidated

Financial Statements

245

Company Financial

Statements

323

Other Information

343

At a Glance

ONWARD

Medical Annual Report 2025

At a Glance

Category-defining leader

with first-mover advantage

Total addressable market

with limited competition

Global Presence

Market Opportunity

We are a commercial stage neurotechnology company

pioneering neuromodulation therapies to restore

movement, function, and independence in people with

spinal cord injury (SCI) and other movement disabilities.

Our Vision

Empowered by independence,

people with spinal cord injury

will enjoy life in the ways

that matter to them

Year

founded

2015

Team

members

140

HQ in the Netherlands

Science and Engineering

Center in Switzerland

US-based field Clinical and

Sales organizations

Listed on Euronext Brussels, Amsterdam,

and Paris (Euronext: ONWD) and OTCQX

(US ADRs: ONWRY)

US FDA Breakthrough

Device Designations

$17B+/€15B+

ONWARD

Medical Annual Report 2025

Investigational implanted platform that combines the ARC

System

with an implanted brain-computer interface (BCI) to restore thought-

driven movement

Clinical feasibility studies ongoing

3 purpose-built neuromodulation platforms

designed to deliver precise spinal cord stimulation:

Investigational implanted neuromodulation platform

Pivotal trial underway

External spinal cord stimulation platform indicated to improve

hand strength and sensation

Commercially available in the US & Europe

Commercialization

ARC

System launched in US clinics in 2025

•

US FDA Home Use clearance received

in November 2025

•

CE Mark certification received in

September 2025

Clinical Validation

•

Safety and effectiveness of ARC

System for upper limb mobility

demonstrated in Up-LIFT clinical trial;

results published in

Nature Medicine

May 2024

•

Positive results from clinical feasibility

studies for ARC

Therapy to improve

blood pressure regulation published

Nature

and

Nature Medicine

September 2025

At a Glance

ONWARD

Medical Annual Report 2025

Forward-Looking

Information / Statements

This document contains certain forward-looking statements, beliefs and opinions with respect

to the financial condition, expected results of actual and planned operations, business and

objectives of ONWARD Medical N.V. (the “Company”). In particular, the words “expect”,

“anticipate”, “estimate”, “may”, “should”, “could”, “would”, “believe”, “outlook”, “potential”, “will”,

“plan”, “pipeline”, “seek”, “intend”, “aim”, “explore”, “target”, “project” and similar expressions

are intended to identify forward-looking statements.

These forward-looking statements are based on current expectations and assumptions and

are subject to known and unknown risks, uncertainties, and other factors, many of which are

beyond the Company’s control, that could cause actual results, performance, or achievements

to differ materially from those expressed or implied in such statements.

You should not place undue reliance on them. For a discussion of factors that could cause

future results to differ from such forward-looking statements, see also the Risk Management

and Control section of this Annual Report. For this reason, we can offer no assurances that

the forward-looking statements published here will prove correct at a future date, and the

Company assumes no duty to update any such forward-looking statements.

At a Glance

Message from

the Chairman

& CEO

ONWARD

Medical Annual Report 2025

Dear Shareholders, Colleagues, Partners, and Collaborators,

ONWARD Medical is dedicated to pioneering neuromodulation therapies to restore movement,

function, and independence for people with spinal cord injuries (SCI) and other movement

disabilities. Leveraging our deep expertise in spinal cord stimulation, we are developing and

commercializing technologies that address the most pressing needs of the people we serve.

Our progress in pursuing this important mission was reflected in our many 2025 achievements.

The need for innovative new therapies is great. SCI is a life-altering condition that affects over

nine million people worldwide. The sudden loss of independence following an SCI presents

enormous challenges for those injured and their loved ones. We are committed to addressing

these challenges by developing and commercializing breakthrough therapies that deliver

meaningful improvements in function and quality of life. The promise of our therapies is

highlighted by Jessie, Nuno, and Marta throughout this report.

2025 was a transformational year for ONWARD. We advanced each of our three breakthrough

technology platforms and established a commercial organization capable of bringing our

therapies to market at scale.

We are pleased to share some of our key achievements:

Message from the

Chairman & CEO

Driving commercial traction

Regaining hand function is a high priority for people living with SCI. The ARC

EX®

System is the

first and only US FDA-cleared technology indicated to improve hand sensation and strength

after SCI, offering unprecedented hope to people with upper extremity paralysis. In 2025,

we built a highly qualified field sales and service organization and commercially launched

ARC

in the US. Our field team is comprised solely of physical and occupational therapists,

whose consultative selling approach resulted in rapid adoption – we sold over 100 units to

more than 80 rehabilitation centers in our first year of commercialization. ARC

has already

reached 25% penetration in US rehabilitation clinics, laying the groundwork for future success,

particularly in marketing the device for the larger home-use opportunity.

In 2024, ARC

was named a TIME Magazine Best Invention. Last year, Fast Company selected

ARC

as one of its “World Changing Ideas,” celebrating its ability to address one of the world’s

most pressing challenges.

Achieving regulatory milestones

Given the early success of ARC

in US clinics, we are aggressively pursuing additional venues

for the technology. ARC

received CE Mark certification in September 2025, enabling its

commercialization for clinic and home use in Europe. This is great news for the European

SCI community.

In November 2025, ARC

received 510(k) clearance to expand use of the therapy at home.

In addition to greatly enlarging the market opportunity for the technology, this clearance

ONWARD

Medical Annual Report 2025

allows people with SCI to benefit from use of the device in the privacy and convenience of

their homes.

In August 2025, the FDA approved an Investigational Device Exemption (IDE) for our ARC

IM®

System, enabling commencement of our Empower BP pivotal study. This study will evaluate the

safety and effectiveness of ARC

in managing blood pressure instability, a critical recovery

target after SCI. The study will involve approximately 20 leading neurorehabilitation and

neurosurgical centers in the US, Canada, and Europe, and it will be among our top operational

priorities in 2026.

Nurturing science & technology leadership

As pioneers in the pursuit of novel neurotechnology therapies to restore movement and other

functions after SCI and other movement disabilities, breakthrough research germane to

our therapies continues to be showcased in publications in leading peer-reviewed journals.

In September 2025, rare concurrent publications in

Nature

and

Nature Medicine

detailed

clinical feasibility results for our investigational ARC

blood pressure instability indication

and explored the underlying mechanism behind the condition and our approach.

ARC

BCI®

is the world’s first and most advanced technology platform pairing an implanted

brain computer interface (BCI) with our implantable spinal cord stimulation system to restore

thought-driven movement. Last year, four additional people were implanted with ARC

BCI

, and

our pioneering work was featured on the long-running and highly respected US news program,

60 Minutes

, highlighting our potential to make thought-driven movement restoration a reality.

Building financial strength

We strengthened our balance sheet in October 2025, successfully raising over EUR 50 million

in equity capital from top-tier life science and technology investors. The transaction was

anchored by our top shareholder and partner, Ottobock SE & Co. Proceeds are being used to

expand our commercial footprint for ARC

, fund the execution of the Empower BP pivotal study,

and complete research and development activities in anticipation of a future ARC

launch.

Looking ahead

Building on outstanding execution in 2025, we are positioned for a successful 2026. The

regulatory approvals earned in the second half of last year allow us to offer ARC

in the home

setting and commercialize the technology in Europe. These new market segments offer the

potential for significant sequential annual revenue growth. They also broaden access to the

device for a significant group of people with spinal cord injury.

On behalf of our entire team, we thank our employees, research collaborators, clinical trial

participants, investors, and business partners for making our recent achievements possible.

We also extend our special appreciation to members of the broader SCI community for their

trust and partnership. Throughout this report, Jessie, Nuno, and Marta share their experiences

– reminding us of the tangible impact we are having on people’s lives.

Thank you for supporting our pursuit of new solutions for people with SCI and other movement

disabilities. We invite you to follow our progress through our website and social media channels

as we continue our mission to restore movement, function, and independence after spinal

cord injury.

Warm regards,

Rob ten Hoedt

Chairman

Dave Marver

Chief Executive Officer

Message from the Chairman & CEO

2025

Highlights

ONWARD

Medical Annual Report 2025

US launch

We launched ARC

in US clinics. ARC

is the first US FDA-cleared technology

indicated to improve hand strength and sensation after SCI.

Clinical evidence

We expanded the body of clinical evidence supporting ARC Therapy with

publications in

Nature, Nature Medicine, Neurology: Clinical Practice,

and

Neuromodulation: Technology at the Neural Interface.

BCI

Now with 7 successful human implants, ARC

BCI

is the world’s first and most

advanced platform pairing a brain-computer interface (BCI) with an implantable

spinal cord stimulation system to restore thought-driven movement after SCI.

CE Mark

We received CE Mark certification for the ARC

System, allowing commercialization

for both clinic and home use in the European Union and in certain other countries,

including the UK and Switzerland.

Home Use

We received US FDA clearance to expand the ARC

System indication for home

use in the US.

2025 Highlights

60 Minutes

The highly respected US news program,

60 Minutes

with Anderson Cooper, aired

a story about our leadership in developing the ARC

BCI

System.

World Changing Ideas

The ARC

System was recognized as one of Fast Company’s 2025 World Changing

Ideas for its potential to transform lives.

IDE

The US FDA approved an investigational device exemption (IDE) for the ARC

System, allowing the initiation of the Empower BP global pivotal study.

EUR 50 million

We added financial strength by raising over EUR 50M in equity capital from top-

tier life science and technology investors.

Rapid adoption

More than 80 US clinics acquired the ARC

System by year-end.

ONWARD

Medical Annual Report 2025

Business

Review

ONWARD

Medical Annual Report 2025

2025 was a transformational year for ONWARD. We advanced each of our three breakthrough

technology platforms and established a commercial organization capable of bringing our

therapies to market at scale. Here are some detailed highlights:

Clinical Evidence

Published in

Nature Medicine

, results from multi-year clinical feasibility studies showed

that participants who received ARC

Therapy saw immediate and robust increases in

blood pressure, as well as reduced frequency and severity of hypotensive symptoms. The

enhanced hemodynamic stability resulted in improved quality of life and greater engagement

in rehabilitation and daily life activities.

In a simultaneous publication in

Nature

, authors were able to identify the neuronal architecture

of the spinal cord that forms after SCI and leads to autonomic dysreflexia (AD), an uncontrolled,

life-threatening elevation of blood pressure. Results showed that electrical stimulation

targeting the specific region of the spinal cord responsible for blood pressure regulation,

called the “Hemodynamic Hotspot,” can activate a competing neuronal architecture to safely

and precisely regulate blood pressure.

Results from the investigator-sponsored Pathfinder2 Study were published in

Neuromodulation:

Technology at the Neural Interface

. The study showed that ARC

Therapy combined with

activity-based rehabilitation improved function in people with SCI. Participants continued

to make gains in upper body strength, trunk control, and balance after one year of treatment.

Results of the LIFT Home Study, published in

Neurology: Clinical Practice

, showed that

continued use of ARC

Therapy at home is effective in maintaining and extending gains

achieved in the clinic.

Business Review

Technology Advancement

We received 510(k) clearance to expand the ARC

System indication for home use in the

US. Launched to US clinics in 2025, ARC

is the first and only FDA-cleared technology

demonstrated to improve hand strength and sensation in people with SCI.

We also received CE Mark certification for the ARC

System, allowing commercialization

for both clinic and home use in the European Union. The CE Mark facilitates a streamlined

regulatory pathway in other countries, including the UK and Switzerland. The first commercial

sales of the ARC

System in Europe occurred in December 2025.

The US FDA approved an investigational device exemption (IDE) for the ARC

System,

allowing the initiation of the Empower BP global pivotal study designed to assess the safety

and effectiveness of this novel technology designed to manage blood pressure instability in

people with SCI. The first participant enrollment was announced in February 2026.

We announced the first human implant of our ARC

Lumbar Lead, targeting restoration of

standing, stepping, and lower limb mobility.

We announced successful implants of the ARC

BCI

Technology in four additional individuals,

bringing the total number to seven. These groundbreaking procedures extend our leadership

in the development of brain-computer interface (BCI) platforms to restore thought-driven

movement for people living with paralysis. These latest implants are part of ongoing clinical

ONWARD

Medical Annual Report 2025

feasibility studies supported by grants from the European Union’s Horizon Europe research and

innovation program through the European Innovation Council, the Christopher & Dana Reeve

Foundation, and the Swiss State Secretariat for Education, Research and Innovation (SERI).

We received two new grants to support early clinical feasibility studies using our ARC

System to help people with Parkinson’s disease. The Michael J. Fox Foundation for Parkinson’s

Research (MJFF) awarded our research partner NeuroRestore a USD 1M grant to explore how

the ARC

System can address mobility challenges. The US Department of Defense awarded

a USD 1.5M grant to ONWARD and NeuroRestore for a clinical feasibility study to explore how

the ARC

System can address blood pressure instability.

Commercial traction

The ARC

System is enjoying rapid adoption. To drive this early success, we built a highly

qualified US field sales and service organization comprised solely of physical and occupational

therapists, whose consultative selling approach resulted in rapid adoption – we sold over 100

units to more than 80 rehabilitation centers in our first year of commercialization. Already

ARC

is 25% penetrated in US rehabilitation clinics, laying the groundwork for future success,

particularly in marketing the device for the larger home-use opportunity.

In early 2025, ARC

was added to US Veterans Affairs (VA) online procurement platforms,

allowing the VA and other government agencies to purchase the breakthrough technology.

In 2024, ARC

was named a TIME Magazine Best Invention. Last year, Fast Company selected

ARC

as one of its “World Changing Ideas,” celebrating its ability to address one of the world’s

most pressing challenges.

Corporate

In summer 2025, we strengthened our Board of Directors by recruiting and appointing

entrepreneur and neurotechnology thought-leader, Tim Denison, PhD, and finance leader

Lucas Buchanan, to our Board of Directors.

Tim is a Professor of Engineering Science and Clinical Neurosciences at the University of

Oxford and a former Vice President at Medtronic, where he oversaw the design of next-

generation neural interface technologies. He is also a co-founder and Chief Engineer of Amber

Therapeutics and has been a co-author on several landmark neurotechnology publications

in journals such as

Nature

and

Nature Medicine

Lucas is the former Chief Financial Officer (CFO) and Chief Operating Officer (COO) of Silk

Road Medical, where he successfully led the company from its founding through its initial

public offering (IPO) and eventual acquisition by Boston Scientific. He brings over 25 years

of experience in commercialization and finance, having previously held roles at The Vertical

Group, Medtronic, and Ernst & Young.

In April 2025, we established a sponsored Level 1 American Depositary Receipt (ADR) program

through the Bank of New York Mellon to facilitate US investor trading and participation in our

growth. The ADRs trade on the OTCQX Best Market under the symbol ONWRY.

In October 2025, we raised over EUR 50M in equity capital. The transaction was supported

by strong demand from top-tier existing and new life-science and technology investors.

Also in October 2025, BNP Paribas Portzamparc initiated coverage with a Buy rating,

expanding the Company’s equity research coverage to five banks, each with Buy ratings.

Business Review

2026

Outlook

ONWARD

Medical Annual Report 2025

After achieving our 2025 objectives, we expect to continue the steady and consistent execution

of our strategy as we advance our innovation pipeline and introduce our breakthrough

therapies to the market:

•

Continued strong demand for the ARC

System and positive feedback from users across

US clinics suggest that we are well-positioned to demonstrate commercial traction

and deliver strong commercial execution in 2026. We plan to expand US marketing of

the ARC

System to the home setting, which would significantly broaden access and

treatment options for people with SCI.

•

We also plan to accelerate the commercialization of ARC

across several key countries

in Europe, including the Netherlands, the UK, Germany, Belgium, Switzerland, France,

and Italy.

•

We expect to explore advantageous engineering and commercial collaboration

activities with our principal strategic investor and partner, Ottobock, and pursue fruitful

collaborations with other partners worldwide.

•

We plan to execute the Empower BP global pivotal study, assessing the safety and

effectiveness of investigational ARC

Therapy to address blood pressure instability

after SCI.

2026 Outlook

•

We expect to initiate a clinical feasibility study involving first-in-human use of the ARC

System to explore its potential to restore bladder function in people with SCI.

•

We plan additional implants to explore future indications in SCI, Parkinson’s disease,

and stroke.

•

The Company expects to announce further advancements in its therapy pipeline, which

includes multiple indications that can be pursued using one or more of our technology

platforms. These indications primarily target spinal cord injury, but several also show

promise in potentially addressing movement or functional challenges resulting from

Parkinson’s disease, stroke, and other movement disabilities.

Overview

ONWARD

Medical Annual Report 2025

Overview

The Case for Innovative Therapies

Nine million people worldwide have a spinal cord injury,

and the annual global incidence of

new injuries exceeds 750,000. In the US and Europe alone, approximately 650,000 people

live with SCI, and the annual incidence of new cases is approximately 30,000.

Spinal cord injury is a highly debilitating, chronic, and often lifelong condition that impacts

individuals, physically and emotionally, as well as their caretakers. When the spinal cord

is injured, communication between the brain and the parts of the nervous system located

beneath the lesion is interrupted, either completely or partially.

While most people associate SCI with paralysis and loss of sensation, there are often other

accompanying challenges such as infection, incontinence, pressure sores, poor blood pressure

regulation, and loss of sexual function. As a result, quality of life following spinal cord injury

can be quite poor for the injured and their caregivers. SCI is also an expensive condition, with

high productivity loss and healthcare expenditures. The average lifetime cost to support a

person with a severe SCI can exceed USD 5M.

Injuries to the spinal cord occur primarily as

a result of accidents and falls, and disproportionately affect young men.

While conventional rehabilitation provides important benefits, most people reach a plateau

in their progress after three to six months. Thereafter, many of those injured face decades

of continuing challenges, declining quality of life, and dependence on others. A significant

unmet need remains as the vast majority of SCI patients seek more meaningful and durable

therapies. ONWARD Medical seeks to solve this unmet need by delivering durable therapies

to improve strength, function, and independence, including for those injured many years ago.

Liu et al. 2023 Spinal cord injury: global burden from 1990 to 2019 and projections up to 2030 using Bayesian age-period-cohort analysis.

NSCISC Traumatic Spinal Cord Injury Facts and Figures at a Glance (2024 SCI Data Sheet); estimated lifetime costs for a person aged

25 at the time of injury with injury severity AIS ABC; costs for a tetraplegic person calculated as the average cost for a person with high

tetraplegia and a person with low tetraplegia.

ONWARD

Medical Annual Report 2025

2024 NSCISC Annual Statistical Report Complete Public Version and European prevalence calculated by annual

incidence* 30 years of additional lifetime expectancy: annual incidence considered using average across >25

papers on SCI incidence within Europe and European countries

2024 NSCISC Annual Statistical Report Complete Public Version and European annual incidence considered

using average across >25 papers on SCI incidence within Europe and European countries

US & Europe

Prevalence

~650,000

US & Europe

Incidence

~30,000

A large unmet medical need

Market

SCI Causes & Patient Proﬁle

2024 NSCISC Annual Statistical Report Complete Public Version

Profile of SCI Patient

•

Nearly half of the injuries occur between the ages of 16 and 30 years

•

80% of new SCI cases are male

Damage to the spinal cord resulting in loss of function

41% Vehicular

24% Falls

17% Violence

10% Sports

3% Medical, Surgical

5% Other

Overview

ONWARD

Medical Annual Report 2025

Our Vision

Empowered by independence, people with spinal cord injury will enjoy life in the ways

that matter to them.

Empowered by independence, people with spinal cord

injury will enjoy life in the ways that matter to them

Our team is pursuing this vision with urgency and determination, developing ARC Therapy

with the intent to commercialize and make our solutions broadly available. We were pleased

to start this process following US FDA approval of the ARC

System in the US in late 2024. We

made meaningful progress advancing ARC Therapy across each of our three breakthrough

technology platforms, and positioned ONWARD as a commercial organization ready to deliver

tangible and scalable solutions to people who need them. Our goal is to bring our innovative

solutions to as many of the nine million people worldwide with SCI as possible.

The work to complete and commercialize our ARC Therapy platforms is aided by 10 FDA

Breakthrough Device Designation awards. While many of these innovations were created

by our R&D team, others have been exclusively licensed from the top neuroscience research

universities around the world, underscoring ONWARD’s position as a pioneer and a leader

in our space.

We are supported in our pursuits by our many strong relationships with SCI advocacy groups

across the globe, such as the Christopher & Dana Reeve Foundation in the United States. We

are grateful for these partnerships and the insights they provide.

At ONWARD, our vision is to enable people with SCI to regain movement and other bodily

functions so they can enjoy life in the ways that matter to them. We develop and commercialize

therapies that address major challenges faced by people with SCI, leveraging the Company’s

ARC

, ARC

, and ARC

BCI

platforms to target a broad spectrum of injury locations and

severities. While our primary objective is to serve the needs of people with SCI, we envision

that our therapies may also benefit other populations with similar challenges, such as people

who have suffered a stroke or who have Parkinson’s disease. We also aim to reward those who

invest their capital, time, and ideas in ONWARD, while engaging in sustainable and equitable

business practices.

Our Strategy

Our objective is to build an enduring, impactful, and successful medical device company

that creates sustainable long-term value and makes a meaningful difference in the lives of

people with SCI and other movement disabilities, and in the lives of those who care for them.

We have developed a two-phase growth strategy as we pursue this objective:

•

Phase 1: Focus on near-term indications. Expected achievements include driving

commercial uptake for ARC

, completing the pivotal study and gaining FDA approval

for ARC

, and advancing our pipeline with the benefit of grant funding.

•

Phase 2: Unlock multiple additional indications and populations by pursuing label and

platform expansion. Expected achievements include driving commercial uptake for

ARC

and ARC

, pursuing cost-effective label expansion leveraging ARC

and ARC

technology, including in Parkinson’s and stroke, and advancing BCI-enabled therapies.

To execute our strategy;

•

We work with leading neuroscience researchers across the globe to identify breakthrough

therapies for people with SCI and other movement-related disorders for which our

therapies have shown promise.

•

We leverage our R&D, clinical, and regulatory capabilities to develop proprietary

technologies that are well suited to deliver our breakthrough therapies at scale, and we

protect these innovations with rigorous IP prosecution.

•

We commercialize these breakthrough therapies in our target markets, using direct

and indirect channels to SCI clinics with rehabilitation programs, and hospitals with

neurosurgery expertise.

Overview

ONWARD

Medical Annual Report 2025

Focus first on near-term indications, then unlock

multiple additional indications and populations

Focus

Expected

achievements

ARC

hand sensation & strength and

ARC

blood pressure instability

Drive commercial uptake for ARC

Complete pivotal study and gain FDA

approval for ARC

Advance pipeline with beneﬁt of grant funding

Phase 1

Drive commercial uptake for ARC

and ARC

Pursue cost-eﬀective label expansion

leveraging ARC

and ARC

technology,

including in Parkinson’s and stroke

Advance BCI-enabled therapies

Growth Strategy

Label and platform expansion

Phase 2

Overview

ONWARD

Medical Annual Report 2025

Basic

Mechanisms

Preclinical

Therapy Development

Clinical

Proof of Concept

Pivotal

Evidence Generation

Commercial

Launch

Overview

ONWARD

Medical Annual Report 2025

Advanced Scientiﬁc & Clinical Research Network

Our unwavering commitment to pioneering innovative therapies that restore movement,

function, and independence after spinal cord injury is rooted in the groundbreaking science

driven by leading researchers. ONWARD has relationships with prominent research centers

around the world.

This includes a close relationship with the ONWARD co-founders and their highly productive

laboratory at .NeuroRestore, a research initiative of Centre Hospitalier Universitaire Vaudois

(CHUV) and Federal School of Technology in Lausanne (EPFL) in Lausanne, Switzerland.

.NeuroRestore is led by Prof. Grégoire Courtine and neurosurgeon Dr. Jocelyne Bloch. Prof.

Courtine and Dr. Bloch continue to provide counsel to the Company as Science and Medical

Advisors, respectively.

ONWARD also partnered with leading clinical research institutions for its Up-LIFT pivotal

trial, the results of which were published in

Nature Medicine

in 2024. The study met all

primary safety and effectiveness endpoints, with no serious device-related adverse events

and a majority (72%) of participants with chronic tetraplegia due to spinal cord injury

achieving clinically meaningful improvements in both strength and function. Participants

also achieved significant and clinically meaningful improvements in sensation following

ARC

Therapy. Building on this work, ONWARD also collaborated with experts to develop

a clinical programming framework for non-invasive transcutaneous spinal cord stimulation

(tSCS) to further support the successful clinical implementation of this novel technology. This

framework, published in Neuromodulation, outlines stimulation parameters demonstrated to

restore upper extremity function in ONWARD’s clinical trials and within the broader body of

literature. The programming framework was found to be safe and well tolerated, and offers

a practical foundation for the clinical use of tSCS in treating cervical spinal cord injury.

ARC Therapy:

a Breakthrough in Neuromodulation Technology

We have developed the ONWARD ARC Therapy to deliver targeted, programmed electrical

stimulation of the spinal cord to restore movement, and independence in people with SCI. By

delivering precisely timed and programmed electrical impulses to specific areas of the spinal

cord, ARC Therapy is designed to mimic the natural pattern of nerve signals sent by the brain.

ARC Therapy can be delivered via three purpose-built neurostimulation platforms: an external,

transcutaneous system, called ARC

, which is commercially available; the investigational

implantable system ARC

; and the ARC

BCI

System which pairs ARC

with an implanted brain-

computer interface designed to restore thought-driven movement via the Company’s wireless

ONWARD DigitalBridge

Spinal cord injury disrupts the brain-body connection

When the spinal cord is injured, communication between the brain and the parts of the

nervous system located beneath the lesion is interrupted, either completely or partially. The

person may lose all feeling or movement

– or both – in these areas. Functions and organs

controlled by the autonomic nervous system may also be affected, leading to difficulty with

breathing, swallowing, stabilizing blood pressure, experiencing sexual arousal, and bowel

and bladder function.

2,3

This disruption of the body-brain feedback loop can cause a host of

debilitating conditions. People with SCI at the thoracic or cervical level are most affected

by this loss of function.

Nevertheless, even in cases of complete SCI, some neural pathways in the spinal cord remain

intact but hypoactive. Currently, rehabilitation approaches aim to mobilize these latent nerve

connections and promote regeneration through intensive physiotherapy. Unfortunately, these

activity-based therapies have limited benefits for people who cannot produce movements

voluntarily. Some symptoms and conditions can be managed with medication, such as

antispasmodics to reduce involuntary muscle contractions, or with devices, such as catheters

to facilitate urination. However, these solutions can be cumbersome and carry the risk of

harmful side effects.

Overview

ONWARD

Medical Annual Report 2025

There is an urgent need for more effective therapies that enable people with SCI to live more

independent, high-quality lives. This is where ONWARD ARC Therapy has the potential to

make a dramatic impact.

ARC Therapy activates intact nerve fibers with biomimetic stimulation

As detailed in the previous section, our ARC Therapy is based on pioneering research led by

Prof. Courtine and Dr. Bloch over the last two decades to pinpoint the location of neurons in

the spinal cord responsible for triggering movement and function.

By delivering precisely timed and programmed electrical impulses to specific areas of the

spinal cord, ARC Therapy mimics the natural pattern of nerve signals sent by the brain. When

combined with voluntary efforts to move, this enables users to improve motor control in the

arms, legs,

5-7

or trunk,

making daily activities, like moving in and out of a wheelchair, much

easier. In addition, ARC Therapy has the potential to improve the management of internal

functions, such as regulation of blood pressure,

and improved bowel and bladder control.

Most participants in clinical trials using ARC Therapy regain some degree of independent

movement, even when stimulation is switched off. ARC Therapy stimulates intact nerve

fibers responsible for carrying messages from the body back to the spinal cord (afferent

nerves), and “retrains” them to perform a different function, demonstrating the plasticity of

the nervous system.

A. S. Burns, R. J. Marino, A. E. Flanders, and H. Flett, “Chapter 3 - Clinical diagnosis and prognosis following spinal cord injury,” in

Handbook of Clinical Neurology, vol. 109, J. Verhaagen and J. W. McDonald, Eds. Elsevier, 2012, pp. 47–62. doi: 10.1016/B978-0-444-52137-

8.00003-6.

M. W. G. Brinkhof et al., “Health conditions in people with spinal cord injury: Contemporary evidence from a population-based

community survey in Switzerland,” Journal of Rehabilitation Medicine, vol. 48, no. 2, pp. 197–209, Feb. 2016, doi: 10.2340/16501977-2039

M. Walter and A. V. Krassioukov, “Autonomic Nervous System in Paralympic Athletes with Spinal Cord Injury,” Phys Med Rehabil Clin N

Am, vol. 29, no. 2, pp. 245–266, May 2018, doi: 10.1016/j.pmr.2018.01.001.

Kathe, C., Skinnider, M.A., Hutson, T.H. et al. The neurons that restore walking after paralysis. Nature 611, 540–547 (2022). https://doi.

org/10.1038/s41586-022-05385-7

F. B. Wagner et al., “Targeted neurotechnology restores walking in humans with spinal cord injury,” Nature, vol. 563, no. 7729, pp. 65–71,

Nov. 2018, doi: 10.1038/s41586-018-0649-2.

E. Formento et al., “Electrical spinal cord stimulation must preserve proprioception to enable locomotion in humans with spinal cord

injury.,” Nature neuroscience, pp. 1–49, 2018, doi: 10.1038/s41593-018-0262-6.

H. Lorach, G. Charvet, J. Bloch, and G. Courtine, “Brain–spine interfaces to reverse paralysis,” National Science Review, vol. 9, no. 10, p.

nwac009, Sep. 2022, doi: 10.1093/nsr/nwac009

A. Rowald et al., “Activity-dependent spinal cord neuromodulation rapidly restores trunk and leg motor functions after complete

paralysis,” Nat Med, pp. 1–12, Feb. 2022, doi: 10.1038/s41591-021-01663-5.

Squair, J.W., Gautier, M., Mahe, L. et al. Neuroprosthetic baroreflex controls haemodynamics after spinal cord injury. Nature 590,

308–314 (2021). https://doi.org/10.1038/s41586-020-03180-w

Overview

ONWARD

Medical Annual Report 2025

Developing Three Platforms

to Deliver ARC Therapy

ONWARD has developed three technology platforms to deliver ARC Therapy: an external

system called ARC

, which is now commercially available, an implantable system called

ARC

, and ARC

BCI

which adds an implantable brain-computer interface to the ARC

platform. ARC

, ARC

, and ARC

BCI

have all been awarded FDA Breakthrough Device

Designation for a range of indications.

All three platforms contain the same basic elements: an electrical pulse generator and

a programmer that enables clinicians to set stimulation therapy parameters and users

to control their therapy within those parameters. The ARC

BCI

has an additional brain-

recording component.

External ARC

System

The

ARC

System

is our external stimulator that is intended to improve

hand strength

and sensation following SCI. The ARC

System is non-invasive and delivers programmed,

transcutaneous electrical spinal cord stimulation. It is intended to be operated in medical

centers by rehabilitation professionals and at home by patients and persons providing

assistance to patients as needed. It is indicated for use in conjunction with functional task

practice in the clinic and take-home exercises in the home to improve hand strength and

sensation in adults with chronic, non-progressive neurological deficits resulting from an

incomplete SCI (C2-C8 inclusive).

ONWARD is currently investigating how ARC

may be used to target additional indications,

such as bowel control and lower limb strength and function in the future.

The

ARC

System

has three main components:

•

Stimulator

that delivers programmed electrical impulses through the skin to the

spinal cord.

•

Electrodes

placed externally on the skin of the neck near the area of the spinal cord that

controls movement in the arms and hands.

•

Dedicated apps for efficiency and ease of use: the ARC

PRO app,

which connects

wirelessly to the Stimulator to program the therapy and adjust parameters, and the

myARC

app

for users to easily control the stimulation during personal use in the

home setting.

Overview

ARC

Neurostimulator

External system for non-invasive, programmed

stimulation of the spinal cord

External Platform

Overview

ONWARD

Medical Annual Report 2025

“I have never been happier in

my life. I’m so grateful for the

team that I’ve built and the

resources that I have to make

this beautiful life everything I

want it to be.”

Jessie Owen

The first thing you notice about Jessie Owen is her broad smile and contagiously bubbly

personality. It’s difficult to imagine that over a decade ago, she sustained a spinal cord

injury and became a quadriplegic in a car accident that also took the lives of her parents.

Ahead of the 2025 holiday

season, Jessie shared her

joy of painting with us

by designing ONWARD’s

seasonal greeting card.

ONWARD

Medical Annual Report 2025

“I lost a lot of things that day,” shares Jessie. “My parents, my autonomy, my job, and my

apartment – because it had stairs.”

Many aspects of Jessie’s daily life suddenly became near impossible tasks without assistance

or planning – such as going to the bathroom, showering, folding laundry, and cooking.

Thankfully, throughout her initial recovery, Jessie could count on a strong friend group to

support her.

Five years after her injury, while searching for solutions to overcome her physical challenges

and regain greater independence, Jessie learned about the Up-LIFT pivotal study evaluating

ARC

Therapy. The ARC

System is non-invasive and delivers programmed, transcutaneous

electrical spinal cord stimulation. It is the first and only US FDA-cleared technology indicated

to improve hand strength and sensation after SCI.

“During the therapy sessions using the technology, I noticed my frustration fading and my

ability to repeat tasks improving,” she says. “I was stacking the blocks higher. I could pour

water. By the end of the study, I felt significantly more confident in my hand strength.”

The benefits of the therapy seeped into Jessie’s daily life as well. Soon, she found it easier to

open jars, use scissors, garden, and was confident enough to adopt a dog. Eventually, she

opened herself to love, got married, and now has two beautiful twin boys.

“Because of this therapy, I can now make my children a bottle. I can pick them up. I can use

my hand to kind of brush the hair out of their eyes when it dangles down to their nose. I can

wipe away their tears, I can hug them.”

Over the years, Jessie has become a valued member of ONWARD Medical’s community, and

we look forward to learning more from her journey in 2026.

Jessie Owen

ONWARD

Medical Annual Report 2025

The ARC

System

The

ARC

System

is an implantable system currently being used to explore a series of

potential indications in clinical feasibility studies. The first target indication for ARC

addressing blood pressure instability after SCI.

Other potential indications may be explored

in the future, including SCI-related bladder and bowel control, spasticity reduction, improved

sexual function, and upper and lower limb mobility (standing and walking), each enabled by

further development of our proprietary lead portfolio and, in some cases, including a BCI.

The ARC

System has four components:

•

Lead

implanted on the spinal cord in the area responsible for driving the movement or

function targeted by the therapy. We are currently developing a family of leads that are

optimized for precise placement in different areas of the spinal cord, varying in shape

and electrode configuration.

•

Neurostimulator

implanted under the skin and connected to the lead through a wire.

When switched on, this device delivers precisely sequenced and calibrated bursts of

electricity to specific electrodes in the Lead.

•

An external

Hub

that connects wirelessly to the Neurostimulator to turn therapy on or

off, set or update the frequency and intensity of the impulses, recharge the device, and

integrate external sensors via wireless connections and sensor-specific algorithms.

The Hub is worn on a belt around the waist.

•

Dedicated apps for efficiency and ease of use.

Apps are available for both clinicians

and users of ARC Therapy. Clinicians use the professional app to create and adjust

stimulation programs using a tablet connected wirelessly to the Hub, and users employ

the personal app to control their therapy within clinician-prescribed programming

parameters. The personal app is expected to be deployed on a mobile phone or

smartwatch and enabled by voice commands as well.

Empower BP: a global pivotal study

Empower BP is a landmark global pivotal study evaluating the safety and effectiveness

of the implantable ARC

System to address blood pressure instability after spinal cord

injury. It is the first global pivotal study to evaluate the Company’s implantable spinal

cord stimulation system. The randomized, double-blinded, sham-controlled study is

expected to involve participants across approximately 20 leading neurorehabilitation

and neurosurgical research centers in the US, Canada, France, Germany, Spain, and

the UK. The study targets individuals with injuries at spinal cord levels C2-T6 and

injury severities of AIS A-D. The first participant was enrolled at Craig Hospital in

Denver, Colorado in early 2026.

Blood pressure instability is a key unmet need after SCI, characterized by chronic

orthostatic hypotension and episodes of autonomic dysreflexia. Published in

Nature

Medicine

in September 2025, detailed results from multi-year clinical feasibility

studies show that participants who received ARC

Therapy saw immediate and

robust increases in blood pressure, as well as reduced frequency and severity of

hypotensive symptoms. The enhanced hemodynamic stability resulted in improved

quality of life and greater engagement in rehabilitation and daily life activities.

Additional benefits included reduced fatigue, improved bowel management, and

increased tolerance of upright postures. Participants reduced or discontinued

traditional treatments for low blood pressure, including compression garments and

medications. Benefits were observed for the duration of the studies, which lasted up

to two years following implant.

Overview

Note: For investigational use only; IPG = Implantable Pulse Generator

ARC

Lead Family

ARC

Neurostimulator (IPG)

ARC

Hub

IPG and leads for direct, programmed

stimulation of the spinal cord

ARC

PRO app

Via ARC

Programmer

myARC

App

Via ARC

Controller

Implantable Platform

Overview

ONWARD

Medical Annual Report 2025

“I cannot live without it. It has

enabled me to live a relatively

normal life. I am fully able

to take care of my children,

thanks to this technology.”

Nuno Abreu

Nuno Abreu, a general surgeon based in Lisbon,

saw his career suddenly interrupted when he

sustained a spinal cord injury in 2021.

ONWARD

Medical Annual Report 2025

Nuno Abreu

“I was bodyboarding and went to catch some waves,” says Nuno. “I dove under, but there was

an unexpected sandbar, and I slammed my head on the bottom. I fractured both my C7 and

first dorsal vertebrae, causing paralysis and loss of sensation below the neck.”

Since then, Nuno has worked to overcome health challenges related to his injury. However,

SCI affects more than just movement. In addition to adjusting to life in a wheelchair, he

faced another, invisible and debilitating challenge: blood pressure instability. Blood pressure

instability and persistent low blood pressure can threaten neurological recovery and negatively

impact cardiovascular health and overall quality of life.

“Blood pressure instability takes control of your life. In fact, most people don’t realize how

important blood pressure is until they lose control of it,” he says. “If you want to talk, you feel

breathless. If you change position when sitting, you feel like you are going to faint.”

Treatment options may include dietary adjustments, medication, and compression garments

to help prevent episodes of low blood pressure. These solutions are not truly effective and

very time-consuming for him, Nuno explains.

Nuno joined our HemOn clinical feasibility study in 2022, to find a long-term solution for

his blood pressure instability. The study evaluated our investigational ARC

System, an

implanted neuromodulation platform designed to deliver targeted and personalized spinal

cord stimulation, in addressing blood pressure instability after SCI.

Since receiving the ARC

System, Nuno has experienced vast improvements. The technology

has helped him regain control of his health, return to work, and play an active part in his

family’s life.

ONWARD

Medical Annual Report 2025

The ARC

BCI

System

The

ARC

BCI

System

is an implantable system currently being investigated to enable thought-

driven movement of the legs and upper extremities. It is the world’s first and most advanced

purpose-designed platform pairing a brain-computer interface with an implantable spinal

cord stimulation system. Seven study participants have now received ARC

BCI

Therapy to

restore movement of their own paralyzed limbs, extending leadership in the development of

BCI platforms to restore thought-driven movement for people living with paralysis.

ARC

BCI

comprises an implant placed epidurally on the motor cortex, designed to record brain

signals associated with movement intention. The system uses Artificial Intelligence (AI) to

decode these signals and translate them into instructions that are wirelessly transmitted

to an implanted neurostimulator, which precisely stimulates targeted regions of the spinal

cord via purpose-designed leads. The Company’s BCI is supported by more than eight years

of human safety data. The ARC

BCI

System was awarded Breakthrough Device Designation

(BDD) by the US FDA in 2024. ARC

BCI

is also included in the FDA’s Total Product Life Cycle

Advisory Program, which provides early regulatory guidance to support the development of

innovative technologies.

Ongoing clinical feasibility studies supported by grants from the European Union’s Horizon

Europe research and innovation program through the European Innovation Council (EIC, under

grant agreements Nos 101057450 and 101070891), the Christopher & Dana Reeve Foundation,

and the Swiss State Secretariat for Education, Research and Innovation (SERI.

Two Priority Indications to Improve

Quality of Life aﬅer SCI

Hand strength and sensation (initial ARC

focus)

Since 2015, 60% of new SCIs in the US have resulted in some form of tetraplegia.

Injuries at

the cervical level of the spine (C1-C7) can result in loss of sensory and motor connections to

all areas below the neck, including the arms and legs. Without the use of our hands, most

activities of daily life (such as grooming and eating) become extremely challenging. Better

hand strength and sensation is therefore an important rehabilitation goal for a majority of

people with SCI, consistently ranked ahead of walking or sexual function.

Blood pressure instability (initial ARC

focus)

Hemodynamic instability, is a key unmet need after SCI, with a significant impact on

cardiovascular health and quality of life. It is a silent yet debilitating complication of spinal

cord injury characterized by chronic orthostatic hypotension and episodes of autonomic

dysreflexia

. Among individuals with tetraplegia, 78% are diagnosed with orthostatic

hypotension, yet only 28% receive treatment – and of those, 91% continue to experience

symptoms including dizziness, lightheadedness, blurred vision, and fatigue. Over time,

persistent low blood pressure can threaten neurological recovery and negatively impact

cardiovascular health.

2,3

Published in

Nature Medicine

, results from multi-year clinical feasibility studies show that

participants who received ARC

Therapy saw immediate and robust increases in blood

pressure, as well as reduced frequency and severity of hypotensive symptoms. The enhanced

hemodynamic stability resulted in improved quality of life and greater engagement in

rehabilitation and daily life activities. Benefits were observed for the duration of the studies,

which lasted up to two years following implant.

Katzelnick CG et al. Blood Pressure Instability in Persons With SCI: Evidence From a 30-Day Home Monitoring Observation. Am J

Hypertens. 2019 Sep 24;32(10):938-944

Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research, Craig Hospital, presented at Unite2Fight Paralysis Conference,

2020. Adapted from Anderson (2004). Targeting Recovery: Priorities of the Spinal Cord-Injured Population. J Neurotrauma. 21(10): 137183

Noreau, L. et al. Development and assessment of a community follow-up questionnaire for the Rick Hansen spinal cord injury registry.

Archives of Physical Medicine and Rehabilitation 94, 1753–1765. ISSN: 0003-9993

Noreau, L. et al. Development and assessment of a community follow-up questionnaire for the Rick Hansen spinal cord injury registry.

Archives of Physical Medicine and Rehabilitation 94, 1753–1765. ISSN: 0003-9993

Phillips, A.A., Gandhi, A.P., Hankov, N. et al. An implantable system to restore hemodynamic stability after spinal cord injury. Nat Med 31,

2946–2957 (2025)

Overview

ARC

BCI

Brain Implant

Brain and spinal cord are reconnected by ONWARD

DigitalBridge

™

to restore thought-driven movement

ARC

BCI

Wearable Data Station

ARC

BCI

Hub

ARC

BCI

Neurostimulator

An intention to move

originates in the brain

The ONWARD ARC

System precisely

stimulates the spinal

cord to produce intended

movement

Think

Move

ARC

BCI

Programmer

Decode

An AI algorithm translates

that intention into instructions

for the neurostimulator.

AI-Powered

Implantable Platform

Overview

ONWARD

Medical Annual Report 2025

“It’s like gaining some

superpower that I did not

have before. Now with

these implants, I’m a real

iron woman.

”

Marta Carsteanu-Dombi

Marta Carsteanu-Dombi was a new mom working at a German tech

company and an aspiring Ironman athlete when her life changed in

an instant. During the cycling portion of a 2018 Ironman race, Marta

suffered an accident that left her with a devastating spinal cord injury.

ONWARD

Medical Annual Report 2025

Marta Carsteanu-Dombi

“We’re still hypothesizing what happened, because nobody saw me,” Marta told CBS’

Minutes

broadcast. “I must have had a pretty tough collision. My spine basically broke in two

dimensions, and there was no sign of nerve connection left to my lower body.”

Today, Marta is helping to push the boundaries of what SCI recovery can look like. She is

one of seven people participating in the groundbreaking trial of ARC

BCI

, our investigational

technology pairing the implantable ARC

System with a braincomputer interface. This system

is designed to enable thought-driven movement for people living with paralysis.

When using it, Marta only needs to think about moving her legs for the electrodes to record brain

activity associated with movement intention. AI then decodes these signals and translates

them into instructions that are wirelessly transmitted to the implanted neurostimulator,

which precisely stimulates targeted regions of the spinal cord via purpose-designed leads,

ultimately activating the muscles in her legs.

Within two days of training with the device, Marta was able to take her first steps again,

supported by a harness and physical therapists guiding her movements. However, the

improvements didn’t stop there. After six more months of hard work and determination, she

was able to walk without the harness.

Being able to stand up and look people in the eye again is also giving Marta her perspective

back. But her greatest motivation for all the hard work is simple: to go to the park with her

family, stand beside them, and take a few steps together.

“It’s not a stroll in the park like how it would look for most people, but for me, it’s just good

enough to make me happy.”

ONWARD

Medical Annual Report 2025

Additional Indications with Signiﬁcant Potential

ONWARD ARC

Therapy to restore mobility in people after SCI

We plan to further investigate the use of ARC

to restore the ability to stand and/or walk

after SCI by restoring movement in the lower limbs. This will build on the success of STIMO, a

clinical feasibility study that determined the preliminary feasibility of ARC Therapy to restore

walking in individuals with chronic SCI resulting in complete or partial paraplegia.

Starting in 2016, the nine participants in this study received high-intensity neurorehabilitation

that combined precisely timed epidural stimulation with over-ground, robot-assisted

rehabilitation training. After completing the STIMO program, all participants reported

improvements in mobility and substantial neurological recovery. Several were able to walk

on a treadmill without using their hands for support and to stand and walk at will, even while

the stimulation was inactive.

While walking may seem like an ambitious goal for many people with SCI, even modest gains

in lower limb function can make a big difference. Incorporating ARC

Therapy in post-acute

clinical rehabilitation programs has the potential to vastly improve long-term outcomes for

the recently injured by promoting neurological recovery. Additionally, we envision that ARC

stimulation may someday be used “on the go” to enable a variety of everyday movements,

including standing and movement of the lower limbs, as part of a person’s therapy and

daily activities.

ONWARD ARC

Therapy paired with brain-computer interface (BCI) to restore

augmented mobility after SCI

In May 2024, an article in

Nature Medicine

reported that a wireless BCI can record a person’s

intention to move to control ARC

Therapy.

Researchers reported that when paired with

ARC

Therapy, an implanted BCI allowed an individual to gain augmented control over

when and how he moved his paralyzed legs. The published data are part of ongoing clinical

feasibility studies investigating the safety and preliminary effectiveness of brain-controlled

spinal cord stimulation after SCI. Seven study participants have now received ARC

BCI

Therapy

to restore movement of their own paralyzed limbs.

ONWARD ARC

Therapy to restore mobility in people with Parkinson’s disease

In November 2023, an article in

Nature Medicine

highlighted the potential for ONWARD ARC

Therapy to address gait challenges related to Parkinson’s disease.

The study participant

described in the article has been living with Parkinson’s disease for nearly three decades.

He has a severe gait disorder that has not responded to conventional therapies. After the

introduction of ARC Therapy, followed by several weeks of rehabilitation, the participant was

able to walk without the previously noticeable gait interruptions.

The Company’s research partner was awarded a USD 1 million grant from The Michael J. Fox

Foundation for Parkinson’s Research (MJFF) to implant the ARC

System in six additional

participants with Parkinson’s disease to investigate the effect of ARC Therapy. This study

will assist ONWARD in determining whether to conduct additional clinical trials with a view

to commercialize ARC Therapy in the future for those living with Parkinson’s disease. The

study is underway with the first participant implanted in late 2024.

Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial | Nature Medicine

A spinal cord neuroprosthesis for locomotor deficits due to Parkinson’s disease | Nature Medicine

Overview

ONWARD

Medical Annual Report 2025

Platform

Indication

FDA BDD

Current stage

Eligible population in US & Europe

Bladder/bowel

~310,000

Stroke upper limb

~680,000

Mobility

~240,000

Parkinson’s – Mobility

~1,100,000

Parkinson’s – Blood pressure

~830,000

Bladder

~450,000

Mobility

~420,000

Upper Limb

~280,000

Stroke – Upper limb

~680,000

Note: The company may modify the pipeline based on clinical progress and marketplace considerations

BDD = FDA Breakthrough Device Designation;

Includes rest of world sales for SCI indications;

Assumes PMA supplement regulatory

pathway leveraging efficacy data from Parkinson’s feasibility studies and safety data from ARC

SCI studies

Various indications under clinical and pre-clinical

evaluation, offering opportunities for future label,

population, and platform expansion

Grant funded studies

Pipeline Overview

Investigator initiated studies

Human PoC expected 2026

Human PoC

Clinical feasibility

Human PoC expected 2026

Overview

ONWARD

Medical Annual Report 2025

Clinical Trials & Regulatory Activity

The development, manufacture, and marketing of ONWARD’s ARC Therapies and associated

technologies are subject to government regulation in the US, the European Union, the UK, and

other countries. To apply for regulatory clearance or approval to market our new devices in

any of these jurisdictions, we must complete extensive human clinical trials that demonstrate

their safety and effectiveness.

Medical devices are regulated according to their risk level and require extensive supporting

safety and effectiveness data to demonstrate their risk to benefit ratio for global regulatory

authority consideration prior to market approval. ARC

is generally designated as a lower

risk device (Class II) and ARC

is expected to be designated a higher risk device (Class III),

requiring different levels of supporting clinical evidence. ONWARD continues to partner with

regulatory authorities globally to ensure that clinical trials are designed and executed in

accordance with the requirements for these different medical device classifications.

Commercialization

The Company’s commercialization strategy is focused on delivering on its mission to restore

movement, function, and independence in people living with spinal cord injury and other

movement disabilities.

We focus on the development of a USD 17 billion market opportunity by

addressing the significant unmet needs of the SCI population. The key tenets of the company’s

commercial strategy that will drive success are as follows:

•

Deliver differentiated technology platforms backed by compelling evidence and clinical science

•

Develop multiple technology platforms that address the spectrum of challenges faced by

people living with SCI

•

Ensure access in key global markets, with an initial focus on the United States and Europe

•

Partner closely with rehabilitation clinics and the healthcare community that serves SCI

patients to grow adoption of novel ONWARD stimulation therapies

2025 saw tremendous commercial progress as the company launched our first platform,

built significant commercial capability and infrastructure, and began to realize our promise

of improving independence for people living with spinal cord injury by putting new technology

solutions in the hands of clinicians and the homes of people with SCI.

ARC

System

In December 2024, the Company received FDA clearance for the ARC

System, marking a

significant regulatory milestone and enabling the commercial

launch of ARC

in US clinics.

By year-end 2025, the Company had established a presence in more than 80 rehabilitation

clinics across the United States, reflecting strong early adoption. In November 2025, the

Company received US FDA clearance for use of the ARC

System in the home, expanding

the addressable market and supporting future growth. During the year, the Company

built a dedicated US sales and support organization made up exclusively of physical and

occupational therapists, to support effective adoption and high-quality clinical engagement.

Overview

ONWARD

Medical Annual Report 2025

Looking ahead, the Company plans to continue expanding our rehabilitation clinic footprint,

which is a critical driver of therapy adoption and expansion. Specialty rehabilitation clinics

serve as the primary users of the Company’s technology and play a central role in prescribing

and enabling home use. Continued growth of this clinic footprint is expected to support

broader patient access, accelerate adoption of the therapy, and drive sustained growth

over time.

Outside the United States, the Company made meaningful progress advancing our

international expansion strategy. The Company obtained CE Mark approval for both clinic and

home use in September 2025, completed additional regulatory registrations in Switzerland

and the United Kingdom, and launched its first European clinics in December 2025 in Germany,

the Netherlands, and Switzerland. The Company commenced the building of a European

sales and support organization, which will be a combination of direct sales and distributors

in key markets.

Building on these foundational milestones, the Company plans to continue

expanding our European footprint in 2026, increasing global access to the technology.

ARC

System

ARC

is the second technology platform that the Company intends to bring to market, further

enhancing solutions for people living with SCI. The first target indication for ARC

is addressing

blood pressure instability after SCI. We expect to commercialize ARC

after the successful

completion of the Empower BP pivotal trial and subsequent regulatory approvals. Commercial

efforts for ARC

are expected to build off the foundational relationships established by the

adoption of ARC

System in rehabilitation clinics, as specialty rehabilitation clinics will be

critical in building therapy awareness and referrals for implants.

Reimbursement & Market Access Strategy

ONWARD is executing a region-specific reimbursement strategy to ensure sustainable

market access for ARC Therapies across the United States and key international markets.

Our approach targets all relevant payer channels – public and private – while also leveraging

partnerships and alternative funding opportunities to ensure broad patient access.

United States

Upon clearance in December 2024, ARC

was immediately available for purchase by US

clinics and for use during in-clinic rehabilitation sessions leveraging existing rehabilitation

billing codes.

Reimbursement for home-use devices, however, requires benefit category and

code assignment, as well as the development of coverage mechanisms, and is a key focus of

the Company’s long-term strategy. This strategy includes:

•

Early engagement with the US Department of Veterans Affairs (VA), where coverage is

available without additional reimbursement determinations

•

Collaboration with the Centers for Medicare & Medicaid Services (CMS) to establish an

appropriate benefit category and HCPCS code

•

Proactive engagement with private insurers to support favorable coverage decisions

and inclusion in private plans

ONWARD has taken significant steps to establish early market access for ARC

in the VA

following its FDA clearance in December 2024. Through our strategic partnership with Lovell

Government Services, a service-disabled veteran-owned small business (SDVOSB), ARC

was successfully added to the VA Federal Supply Schedule (FSS) and GSA Advantage — two

key procurement platforms for federal healthcare providers. These listings enable streamlined

purchasing by VA hospitals, Department of Defense (DoD) facilities, and other federal buyers.

Upon clearance of the device for home-use, the home use version of the device was also added

to the FSS and GSA Advantage, enabling access for veterans. Engagement with the VA will

grant early access to a large population of individuals living with SCI and will generate early

invoicing and usage data that will be instrumental in broader reimbursement activities.

Overview

ONWARD

Medical Annual Report 2025

The company plans to begin formal engagement with CMS in early 2026 to obtain a benefit

category and code recommendation for ARC

. In parallel, the company will begin structured

engagement with

payers on

case-by-case patient access and will continue to build payer-

relevant clinical and economic evidence.

The Company’s reimbursement strategy for ARC

remains under development, but is

expected to include a category III CPT code application to enable early access following US

FDA approval and exploration of programs like the New Technology Add-On Payment (NTAP)

and Transitional Pass Through (TPT) to bridge reimbursement gaps in both inpatient and

outpatient settings.

Germany

Germany is expected to be a prominent market for ARC

and ARC

, given its advanced SCI

rehabilitation infrastructure and comprehensive reimbursement framework. Similar to the

United States, ARC

was immediately available upon CE marking for clinics to purchase for

use with patients during in-clinic sessions, leveraging existing reimbursement schemes.

For

home use, ARC

will require additional coverage determinations under both public and private

insurance. ONWARD is preparing for registration in the Hilfsmittelverzeichnis (HMV),the official

list of durable medical equipment reimbursable by public insurers,and anticipates a multi-

year pathway that may require evaluation by the G-BA (Gemeinsamer Bundesausschuss).

During this process, the Company plans to

pursue case-by-case patient access

and also

plans to partner with entities that specialize in spinal trauma and rehabilitation (BG Clinics,

Worker’s Compensation) that have experience negotiating reimbursement and access for

advanced technologies.

ARC

is expected to be reimbursed under Germany’s DRG-based inpatient payment system,

with the potential for supplemental payments (Zusatzentgelte) to reflect the cost and

complexity of the implant procedure. These pathways are well established, and we will continue

to monitor hospital reform in Germany and will adjust our reimbursement strategy accordingly.

Other markets

Across other major European markets, ONWARD is pursuing country-specific reimbursement

strategies based on the respective national frameworks. While Europe lacks a unified

reimbursement model, we are building targeted access plans that focus on:

•

Public health insurers

•

Private payers

•

Workplace and accident insurance funds

•

Disability and long-term care insurers

•

Military and veteran health systems

•

Charities and SCI foundations that provide financial assistance

These efforts began in 2022 and will continue through 2026 and beyond, with each market

approached based on its readiness and strategic alignment with ONWARD’s commercial goals.

Overview

ONWARD

Medical Annual Report 2025

Call Points

Specialist SCI and

general rehab clinics

Customer concentration allows us to build

direct sales channel and establish enduring

and valuable relationships

Geographical Focus

US and select European markets with

sophisticated neurorehabilitation

infrastructure, clinical partnerships,

and/or favorable reimbursement for

medical innovation

~530

~450

Source: Company estimates

Targeting &

Channel Strategy

Europe

Specialist

rehab centers

~80

Overview

Culture

ONWARD

Medical Annual Report 2025

At ONWARD, we aim to attract talented and ambitious individuals who bring creativity

to everything they do by offering a compelling vision, groundbreaking technology, and

competitive rewards. Our team reflects a rich diversity, with 23 nationalities represented,

strengthening our perspectives and reinforcing our commitment to innovation.

We strive to position ONWARD as an employer of choice by cultivating a positive, purpose-driven

culture anchored in our ONWARD Commitments. Building on the foundation of the original

ONWARD Code, these Commitments represent a clearer, more action-oriented expression of

who we are and how we work, aligning our behaviors with the needs of the spinal cord injury

community and the expectations of a commercial-stage, growth-oriented organization.

Our ONWARD Commitments – We Serve with Purpose; We Act with Integrity; We Lead with

Courage; and We Grow through Collaboration – guide how every employee contributes to

our mission. They define what it means to work ethically, boldly, and collaboratively, while

remaining deeply connected to the communities we serve. Together, they clarify not only what

we aim to achieve, but how we achieve it, collectively and responsibly.

The ONWARD Commitments are embedded throughout the employee lifecycle. They are

incorporated into our hiring and promotion processes, ensuring alignment between our

values and the people who join and advance within the organization. Introduced during

onboarding, the Commitments are continually reinforced through company-wide forums,

team discussions, and performance conversations. They form the foundation of an open,

transparent, and psychologically safe workplace, one in which employees are encouraged

to raise concerns in good faith, with the assurance that issues will be handled confidentially,

thoughtfully, and without retaliation.

Culture

Expectations tied to the ONWARD Commitments evolve as individuals grow within the

organization. We recognize three progressive levels of behavioral application, from individual

contributors and people managers to senior leaders, reflecting increasing scope, influence,

and accountability. At each level, employees are expected not only to demonstrate the

Commitments personally, but, as responsibility grows, to model, enable, and embed them

across teams and the broader organization.

The Commitments also underpin our performance philosophy. Purpose-driven service, ethical

decision-making, courageous leadership, and cross-functional collaboration are integrated

into our performance management and development frameworks at every career stage. This

alignment ensures that how we work is valued, measured, and developed with the same rigor

as what we deliver.

Ultimately, the ONWARD Commitments shape a culture where individuals feel valued,

supported, and empowered to grow. By living these Commitments each day, we strengthen

our collective performance and ensure our work delivers meaningful and lasting impact for

the people and communities we serve.

The Culture Club, an employee-driven initiative, reinforces our cultural values, fosters

collaboration, and strengthens shared understanding.

ONWARD

Medical Annual Report 2025

Competitive hiring

ONWARD recruits from a global talent pool and seeks to attract high-caliber individuals

inspired by our mission and motivated by the opportunity to deliver meaningful breakthroughs.

Our approach to hiring is aligned with the Company’s strategic evolution and long-term

growth objectives.

As ONWARD has transitioned into a commercial-stage organization, our recruiting function

has evolved to support this shift across key functions, including commercial, operational,

and corporate capabilities. In 2025, this evolution included a focused effort to strengthen

our US sales organization and related commercial roles, supporting market expansion and

execution readiness.

We maintain strong oversight of the hiring process, leveraging professional networks,

partnerships with leading academic institutions, and an employee referral program that

encourages recommendations aligned with our culture and values.

To attract and retain exceptional talent, ONWARD offers competitive compensation and

benefits. Our remuneration philosophy includes short-term incentives, as well as an employee

stock-option plan that promotes share ownership and alignment with long-term value

creation. Awards under this program are subject to continued employment through vesting,

reinforcing a shared commitment to sustained success.

A great place to work

ONWARD places a strong emphasis on employee engagement and the continuous improvement

of the employee experience. Our established engagement framework enables regular listening,

meaningful dialogue, and action-oriented follow-through across the organization.

Employee feedback is gathered through a structured, two-tiered approach: an annual

comprehensive engagement survey and a shorter bi-annual survey designed to take the

organizational pulse. Insights from these surveys are reviewed across the organization to

inform priorities, guide decision-making, and support continuous improvement. This approach

represents an evolution from 2024, strengthening our ability to monitor trends while enabling

more focused and timely action.

The annual comprehensive survey was refined to provide greater granularity across key

drivers of engagement, enabling deeper insight into employee experience trends and more

targeted, data-driven actions at both the organizational and team levels.

These surveys are complemented by an anonymous platform that allows employees to freely

share ideas, suggestions, and concerns.

Our engagement efforts are supported by ongoing improvements across the employee

lifecycle. We conduct structured check-in surveys for new hires at key milestones, at the

end of the first week, after one month, and after three months, alongside employee journey

interviews and comprehensive offboarding interviews.

Together, these mechanisms ensure feedback is captured consistently at every stage of

employment, allowing us to continuously refine our practices, strengthen engagement, and

enhance overall organizational performance.

Employee well-being

In 2025, we continued to focus on supporting the well-being of our employees through

initiatives that promote balance, engagement, and a positive workplace culture.

This year’s programs included an Appreciation Week, a Well-being Month, and a Step

Challenge, all designed to encourage connection, healthy habits, and recognition across

the organization. We also highlighted key awareness days to encourage reflection and

conversation around well-being.

Flexible hybrid working arrangements remained in place, enabling employees to manage

their professional and personal commitments effectively.

These efforts demonstrate our ongoing dedication to creating a positive and supportive work

environment for all team members.

Culture

Privacy & Data

Governance

ONWARD

Medical Annual Report 2025

ONWARD is committed to ensuring that cybersecurity and privacy are built into our products,

services and business processes throughout their lifecycle. As a commercial-stage medical

technology company, we process personal data in the course of our research, development,

manufacturing, commercialization, and post-market activities. When we collect patient

health data, we do so only for clearly defined and legitimate purposes, including the

assessment, delivery, monitoring, and continual improvement of the safety, performance,

and effectiveness of our approved and investigational therapies, as well as to meet regulatory,

quality, vigilance, and post-market surveillance requirements. We apply appropriate technical

and organizational safeguards to protect personal data and comply with applicable data

protection and cybersecurity laws in all jurisdictions in which we operate.

We are subject to various regional, national, and state laws that protect the confidentiality

and security of patient health information, including patient medical records and other

forms of personal information. We are committed to applying the two most rigorous privacy

regulations to our global operations, namely the United States’ Health Insurance Portability

and Accountability Act (HIPAA) and the European Union’s General Data Protection Regulation

((EU) 2016/679; GDPR). This legislation includes the data subject’s right to access or amend

certain records containing protected health information or to request that their use or

disclosure be restricted.

Privacy & Data

Governance

We have appointed an external Data Protection Officer. This service is provided by DPO

Consulting, a firm with extensive experience in Data Protection Regulations. In addition,

we have established a Data Privacy Committee and a Global Data Protection Policy

complemented through a series of implementing procedures, mechanisms and employee

training to ensure compliance with GDPR and HIPAA, as applicable.

Through the position of VP of Legal and Chief Compliance Officer, we have strengthened the

integration of legal and privacy assessments across the organization in collaboration with

the Data Protection Officer.

We have also strengthened the compliance of our products with cybersecurity and data

protection requirements under GDPR and HIPAA. We have established traceability in

accordance with relevant standards and built evidence that our products are compliant with

the regulations. We continue to strengthen and mature our data protection and cybersecurity

processes to ensure compliance with applicable privacy and health data regulations, including

GDPR in the European Union and HIPAA in the United States. These efforts are focused on

building a robust, scalable data privacy and security framework supporting the commercial

launch of ARC

in the United States, including use in clinical settings and in patients’ homes,

as well as commercialization and deployment across the European Union. We regularly train

our staff on security and privacy issues and employ best practices for the administration of

our systems and infrastructure.

Sustainability

ONWARD

Medical Annual Report 2025

Additional details regarding ONWARD’s sustainability priorities, approach, and performance

can be found in a separate sustainability summary available on ONWARD’s investor website.

ONWARD is committed to being a responsible organization that creates sustainable long-term

value for all stakeholders. Sustainability principles are integral to how we do business. They

are captured in the ONWARD Commitments, Articles of Association (AOA), Code of Conduct

(COC), and the Company’s culture, business practices, operations, and supplier agreements.

Sustainability principles

ONWARD’s sustainability strategy rests on five core principles:

•

Innovating for the underserved.

There is no cure for SCI. ONWARD therapies are among

the first to offer the potential to help people with SCI regain movement and other functions,

improving quality of life for a large group of underserved people. The Company’s products

also have the potential to benefit large populations of stroke sufferers and Parkinson’s

disease patients. Underscoring the innovative nature of its work, ONWARD has been

granted 10 Breakthrough Device Designations (BDD) by the US FDA

and has

issued

nearly 290+ patents worldwide (including EP validations). The Company continuously

innovates and strives to get such designations for other indications to make a difference

in the lives of even more people.

•

Partnering with patient groups.

ONWARD enjoys excellent relationships with the

world’s leading patient advocacy groups for people with SCI. The Christopher & Dana

Reeve Foundation, the world’s largest such organization, is an investor in ONWARD.

The Company also collaborates with Wings for Life in Europe, the Praxis Foundation in

Canada, and the International Spinal Research Trust in the UK. By collaborating with

these groups, ONWARD is able to innovate in ways that make the greatest difference for

people with SCI.

Sustainability

101

ONWARD

Medical Annual Report 2025

•

Attracting and retaining the best talent.

To deliver on its vision, ONWARD is committed

to creating an unrivaled environment for its employees. The Company cares deeply about

the well-being and continuous development of its staff, as evidenced by the various

programs put in place, such as its well-being program. Having a highly motivated and

engaged workforce enables the Company to retain and attract top talent. It also engages

with people with SCI as consultants, enabling staff to have a better understanding of the

challenges that they face.

•

Minimizing our environmental footprint.

In its operations, the Company strives to

reduce its carbon footprint by replacing air travel with videoconferencing, except for the

most pressing business needs, and by encouraging a hybrid workplace, thus reducing

employees’ commute. Additionally, ONWARD works with suppliers to minimize waste

in the manufacturing process, consume electricity generated almost exclusively from

renewable sources, and implement recycling programs in its offices.

•

Maintaining high ethical and quality standards.

ONWARD strives to act with openness

and integrity. The Company is committed to high ethical standards in dealing with

business partners, as outlined in the Code of Conduct, which covers anti-bribery and

anti-money laundering, government relations and political affairs, and international

business practices. The Code of Conduct ensures that employees understand what is

expected of them when acting on behalf of the Company. ONWARD aims to comply with

all applicable anti-bribery laws, including the US Foreign Corrupt Practices Act. The

highest quality and safety standards are applied to all of ONWARD’s activities, and the

Company ensures strong labor practices in its supply chain. ONWARD also works hard to

secure key personal data and comply with GDPR and HIPAA, uphold human rights, and

operate in geographies with a strong track record in this area. Additionally, ONWARD

maintains high quality standards – details can be found in the “Quality” section of the

Annual Report.

In 2024, ONWARD Medical was awarded a silver medal by EcoVadis, the world’s largest

provider of business sustainability ratings. The award placed the Company in the top 15%

globally of companies assessed by EcoVadis in the past 12 months. The EcoVadis assessment

evaluates 20+ sustainability criteria across four core themes: Environment, Labor & Human

Rights, Ethics, and Sustainable Procurement. More than 130,000 companies globally have

been rated by EcoVadis.

Sustainability

Operational

Review

105

ONWARD

Medical Annual Report 2025

Science and intellectual property

As the pioneer in its space, ONWARD has forged relationships and exclusively licensed

important intellectual property from many of the world’s leading neuroscience research

laboratories, such as: .NeuroRestore, Switzerland; Caltech, US; University of California at

Los Angeles, US; University of Louisville, US; University of British Columbia, Canada; and

CEA, France.

The Company’s primary research partnership is with .NeuroRestore, a joint research initiative

of the Federal School of Technology in Lausanne (EPFL) and the Lausanne University Hospital

(CHUV), Switzerland. In 2021, the Company signed a framework agreement with .NeuroRestore

governing future research initiatives, as well as contracts covering existing and ongoing

research on blood pressure, mobility, brain-computer interfaces (BCI) and brain-controlled

spinal cord stimulation. In addition, ONWARD supported .NeuroRestore research on upper

limb mobility and incontinence.

Benefitting from these research collaborations, and combined with its own innovations, the

Company’s formidable IP portfolio totals 290+ issued patents, including European Patent

(EP) country validations, further reinforcing the Company’s pioneering science and first-

mover advantage.

Research and development

In 2025, ONWARD’s product development team made advancements across several

development initiatives:

•

ARC

System: Product improvements related to human factors engineering were

implemented to comply with home-use requirements and were successfully cleared by the

Operational Review

US FDA, thereby opening the home-use market in the United States. In parallel, additional

product adaptations were completed to comply with the European Medical Device

Regulation (MDR), leading to successful approval for use in both rehabilitation centers

and home-use settings in Europe. Furthermore, design-robustness enhancements and

manufacturing process improvements were implemented, strengthening product quality

and supporting scalable production. Additionally, development of a first-generation

digital platform advanced in 2025, enabling remote servicing and usage insights, and

will continue into 2026.

•

ARC

System development: The ARC

platform has continued to evolve and mature with

the completion of several technological updates, including enhancements supporting

clinical research activities, user experience, and system performance, as well as the

incorporation of features informed by insights gained from field use. The platform

successfully received investigational device exemption (IDE) approval to initiate the

Empower BP pivotal study and has begun preparations for the Premarket Approval

Application (PMA) milestone.

•

ARC

BCI

development: The company signed an exclusive agreement with CEA in 2024 to

further develop the investigational WIMAGINE

BCI technology. Technology transfer was

completed in 2025, followed by continued development activities throughout the year in

support of ongoing research activities.

•

Engineering operations: The R&D department continued to mature in 2025 and was able

to advance multiple projects across the ARC

, ARC

, and ARC

BCI

platforms, while also

progressing several research initiatives. A matrix approach combining functional and

program responsibilities, complemented by operating mechanisms and KPIs, has helped

drive improvements and continues into 2026.

107

ONWARD

Medical Annual Report 2025

ONWARD is also engaged in several joint research activities, with significant milestones

achieved throughout 2025:

•

Brain-controlled locomotion: The second and third study participants were successfully

implanted in the Think2Go clinical feasibility trial, evaluating the potential of ARC

BCI

Therapy to restore thought-driven lower limb function in individuals with SCI.

•

Brain-controlled upper limbs: The second and third study participants were successfully

implanted in the UP2 clinical feasibility trial evaluating the potential of ARC

BCI

Therapy to

restore upper limb function in individuals with SCI.

•

Spinal cord stimulation to facilitate locomotion in individuals living with Parkinson’s

disease and partnership with the Michael J. Fox Foundation: The second, third and fourth

study participants were successfully implanted in the SPARKL study, a clinical feasibility

study which aims to test the effectiveness of ARC

Therapy in addressing locomotor

deficits in individuals with Parkinson’s disease.

•

Spinal cord stimulation for blood pressure regulation in individuals living with Parkinson’s

disease:

The first study participant was successfully implanted in the PD-HemON clinical

feasibility trial, evaluating the effectiveness of ARC

Therapy to address blood pressure

instability in individuals living with Parkinson’s disease, reflecting the potential of our

therapies to address a range of critical health challenges.

•

Brain-controlled spinal cord stimulation after stroke: The Company, together with

research partners, submitted a request to Swiss competent authorities to conduct the

Stroke-BSI clinical feasibility trial to evaluate the use of ARC

BCI

Therapy for improving

upper and lower limb functions in individuals living with subcortical stroke.

Clinical and Regulatory

ONWARD’s clinical and regulatory team had a productive 2025, advancing their regulatory

position by receiving market authorization in Europe for ARC

and FDA approval for ARC

Home Use aligning indications globally. This expansion allows greater market access and

supports broader patient adoption for both in-clinic and home use.

Additionally, ONWARD received US FDA IDE approval for its pivotal clinical trial in August and

ended the year by activating three clinical sites in the United States to begin study enrollment.

The Company is engaging in discussions with national competent authorities in preparation

for a series of 2026 submissions pertaining to the Empower BP study allowing more countries

to participate in the pivotal trial.

Quality

The Company operates a global quality management system (QMS) covering activities in

the United States, the Netherlands, and Switzerland. This QMS complies with applicable

medical device regulations and standards, including the EU Medical Device Regulation (MDR

2017/745) and the US Quality System Regulation (21 CFR Part 820).

The Company obtained ISO 13485 certification for design and development in 2018. In 2022,

the scope of certification was expanded to include the clinical applications targeted by ARC

Therapy, as well as additional activities supporting the manufacturing and distribution of

ARC

devices.

The most recent QMS audits were successfully completed in September 2025 by TÜV SÜD, a

globally recognized notified body with extensive experience in neuromodulation devices. The

audit scope included a surveillance assessment for ISO 13485 certification and conformity

assessment under the EU MDR, resulting in the issuance of an EU Quality Management

System Certificate in accordance with Annex IX, Chapter I.

Commercial operations

Following US FDA market authorization, the Company initiated the commercialization of the

ARC

System in US clinics. As part of the initial limited phase of the commercial launch, the

Company deployed a US field organization, established a sales and service process, and built

a roster of reference clinics.

In the second half of the year, the Company

received CE Mark certification for its ARC

System under the EU MDR, enabling commercialization in the European Union and certain

other countries, and US FDA 510(k) clearance to expand the ARC

System indication for home

use in the US. The Company demonstrated strong commercial traction throughout the year

and sold 117 ARC

Systems.

Operational Review

109

ONWARD

Medical Annual Report 2025

Assuming positive clinical results from our Empower BP global pivotal trial and subsequent

regulatory approvals, ONWARD aims to launch ARC

commercially in the US and select

European markets thereafter to restore hemodynamic stability after SCI. Additionally, the

Company will continue to investigate the use of ARC

and ARC

BCI

for additional indications,

for instance, to improve mobility by restoring movement in the legs and feet, with the goal of

bringing these therapies to market in the near future.

The Company has deployed its own direct sales and service organization in the United States

and select European markets and plans to use distribution partners in most other geographies.

Supply Chain / Manufacturing

The Company has forged relationships with leading, MedTech-focused contract manufacturing

organizations (CMOs) to assist with the manufacture of products and product components.

Selected CMOs undergo a rigorous screening and selection process and are subject to robust

quality and performance monitoring. ONWARD conducts regular supplier audits and will

continue its supplier vigilance programs in 2026. The Company maintains market surveillance

of components and raw materials to monitor quality and supply issues, and explores alternative

sourcing options, paying particular attention to costs and delivery timelines.

Financing

To execute its strategy and operational priorities, ONWARD continues to invest in research

and development, advance its clinical programs, and support the commercialization of the

ARC

system. During 2025, the Company completed equity financing activities generating

EUR 50.8M, further strengthening the Company’s balance sheet and enhancing financial

flexibility to support ongoing operations, strategic investments, and continued execution

of its clinical and commercial roadmap. Net cash on the balance sheet at year-end 2025

amounted to EUR 68M (please refer to the Non-IFRS financial measures included in Other

Information for the definition of net cash), positioning the Company to continue executing on

its clinical and commercial strategy. Ottobock SE & Co. KGaA remains a strategic investor,

supporting the Company’s long-term ambitions.

Operational Review

Financial

Review

113

ONWARD

Medical Annual Report 2025

This financial review should be read with the operational review and the Company’s

consolidated financial statements in this Annual Report, which have been prepared in

accordance with International Financial Reporting Standards (IFRS) as published by the

International Accounting Standards Board and as adopted by the European Union and with

Part 9 of Book 2 of the Dutch Civil Code.

EUR’ Million

2025

2024

Total Revenues & Other Income

5.4

1.7

Total Operating Expenses

Research & Development Expenses

Clinical & Regulatory Expenses

Marketing & Market Access Expenses

Quality Assurance Expenses

General & Administrative Expenses

(45.3)

(12.3)

(5.7)

(8.1)

(2.4)

(16.8)

(36.6)

(13.8)

(4.8)

(3.4)

(2.0)

(12.6)

Operating Loss for the Period

Net Finance Expense

Income Tax

(40.9)

(0.6)

(0.3)

(34.9)

(0.9)

0.0

Net Loss for the Period

(41.8)

(35.7)

EUR’ Million

31 December

2025

31 December

2024

Net Cash Position at the end of the Period

Interest-bearing Loans

Equity

68.1

(13.0)

55.3

60.0

(14.0)

48.1

Financial Review

Total Revenues & Other Income

Revenue increased significantly in 2025 compared to 2024, primarily driven by the

commercialization of the ARC

system following FDA clearance obtained on 19 December

2024. Revenue from the sale of ARC

devices grew from € 77 thousand in 2024 to € 3.7 million

in 2025, reflecting the Company’s transition into its early commercial phase.

Other income of € 1.7 million, consisting primarily of grant funding, remained consistent

year over year (2024: € 1.7 million). During 2025, the Company successfully negotiated an

amendment with the European Innovation Council to align the grant with the geographic origin

of the activities performed and secured replacement funding from the Swiss State Agency

for Education, Research and Innovation (SERI) for the NEMO BMI grant activities conducted

in Switzerland. As a result, grant income has been recognized in 2025 to reflect progress on

the NEMO BMI grant from inception through the end of 2025. This represents approximately

€ 1 million of the 2025 income.

Research & Development Expenses

Research and development (“R&D”) expenses decreased by approximately 11%, from

€13.9

million in 2024 to €12.

million in 2025. The decrease was primarily driven by lower

external

development costs and reduced employee-related expenses, reflecting the

timing of

development activities and a lower level of overall R&D spending during the year.

R&D expenses consist primarily of product development activities, engineering efforts to

advance and support the Company’s technology platforms, testing, consulting services

and other costs directly attributable to the development of its therapies. These expenses

mainly include personnel-related costs for R&D employees, share-based compensation and

outsourced development services.

In 2025, patent and related intellectual property costs are presented within R&D expenses,

reflecting management’s view that these expenditures are directly linked to and support

Financial Review

115

ONWARD

Medical Annual Report 2025

the Company’s ongoing development activities. These costs primarily relate to securing,

maintaining and expanding the Company’s intellectual property portfolio. Such expenses are

recognized as incurred, as they do not meet the criteria for capitalization under applicable

accounting standards. The updated presentation aligns the classification of intellectual

property protection costs with the underlying research and development activities and

enhances comparability with industry practice within the sector.

R&D expenses also include the costs of sponsored research activities undertaken by

universities with which ONWARD collaborates. This includes the close working relationship

with one of the founders, Grégoire Courtine, Scientific Advisor, Director at .NeuroRestore and

Professor at EPFL.

Clinical & Regulatory Expenses

Clinical expenses increased by 21%, from €4.8 million in 2024 to €5.7 million in 2025. In 2025,

clinical expenses were primarily driven by activities supporting the FDA submission for

ARC

Home Use clearance, regulatory efforts related to obtaining the CE mark in Europe,

and continued preparations for the pivotal Empower BP study. These initiatives reflect the

Company’s focus on expanding regulatory approvals and advancing key clinical programs to

support future commercialization. Clinical expenses include employee salaries and related

costs, including share-based compensation, clinical trial management and monitoring,

payments to clinical investigators, data management, consulting services, and travel

associated with clinical trial activities.

Marketing & Market Access Expenses

Marketing and market access expenses increased by 142%, from € 3.4 million in 2024 to €

8.1 million in 2025, primarily reflecting investments in personnel to establish the commercial

infrastructure required to support ARC

commercialization across the United States, Europe,

and other international markets.

Quality Assurance Expenses

Quality assurance expenses increased by 17% from € 2.0 million in 2024 to € 2.3 million in

2025. Quality assurance expenses relate to activities undertaken to maintain and enhance

ONWARD’s quality systems and regulatory compliance capabilities in support of ongoing

regulatory initiatives, manufacturing readiness, and commercial activities. During 2025,

efforts were primarily focused on supporting regulatory submissions, including FDA clearance

for ARC

home use, CE mark activities in Europe, and broader quality oversight as the

Company continues to scale its operations. These expenses include employee salaries and

related costs, including share-based compensation, as well as consulting, testing, and travel

associated with quality management and risk assurance activities.

General & Administrative Expenses

General and administrative expenses increased by 33%, from € 12.6 million in 2024 to €

16.8 million in 2025.

General and administrative expenses increased in 2025 compared to

the prior year, reflecting the continued scaling and maturation of the Company’s operating

infrastructure as it advances its commercial activities. The increase was primarily driven

by higher personnel-related costs, investments in operational capabilities, and expanded

corporate support functions required for a growing listed organization. Expenses also include

professional services associated with strategic financing activities, governance, and other

corporate matters supporting the Company’s evolving operational and regulatory environment.

Board-related costs increased modestly during the year following the strengthening of the

Board, in line with ongoing governance needs.

Net Finance Expense

The net financial expense decreased by 38%, from € 0.9 million in 2024 to € 0.6 million in 2025.

Interest expense relates to the interest on the debt facility from Runway Growth. The Company

continued to invest excess cash in short-term deposits with reputable banks yielding interest

income. Interest income decreased in 2025 as lower central-bank interest rates led to reduced

returns on short-term EUR and CHF deposits. The foreign exchange loss recognized in 2025

primarily reflects the remeasurement of the USD-denominated term loan at the reporting

date exchange rate, with smaller impacts from operational foreign-currency transactions.

Income Tax

In 2025, the Company recorded a modest tax expense, resulting in an effective tax rate

of approximately 0.75%. The effective tax rate primarily reflects the limited recognition of

Financial Review

117

ONWARD

Medical Annual Report 2025

deferred tax assets on losses generated in certain jurisdictions, as the recoverability of these

losses is not yet considered sufficiently probable.

The tax expense for the year was also impacted by non-deductible expenses, including share-

based payments, and certain permanent differences related to financing arrangements within

the Group. These effects were partially offset by the utilization of tax losses in the United

States and the benefit arising from the Foreign-Derived Intangible Income (FDII) deduction.

Overall, the Company’s tax position reflects its current stage of development, with taxable

income generated in certain jurisdictions while losses in others do not yet result in recognized

deferred tax assets. Deferred tax assets are recognized only to the extent that it is probable

that future taxable profits will be available against which the losses can be utilized.

Cash Position

The Company ended the year with a positive net cash balance of € 68 million (2024: € 60

million). The full amount comprises cash and cash equivalents since none of the short-term

fixed deposits exceeds a period of 3 months.

The table below summarizes the Company’s cash flows for the years 2025 and 2024.

EUR’ Million

2025

2024

Net cash generated / (used) from operating activities

Net cash (used) / generated from investing activities

Net cash generated / (used) from financing activities

Effect of exchange rates on cash and cash equivalents

)

(0.4)

47.3

–

(31.8)

(0.2)

62.6

(0.4)

Cash outflow from operating activities increased from € 31.8M in 2024 to € 3

9.1

M in 2025. The

increase in operating cash outflows primarily reflects continued investment in personnel and

infrastructure to support the commercialization of ARC

and the scaling of the Company’s

operational capabilities. Changes in working capital also contributed to the movement,

including modest increases in trade and other receivables and trade and other payables.

Financial Review

Cash flow from investing activities in 2025 reflects

the acquisition of property, plant,

and equipment.

The cash inflow in 2025 is attributable to the equity financing raised net of transaction costs

in October 2025.

The impact of exchange rates primarily relates to the remeasurement of the Company’s USD-

denominated loan balance. As this represents a non-cash accounting adjustment recognized

in profit or loss under IFRS, it does not result in a corresponding cash flow.

Interest-bearing Loans

Interest-bearing loans decreased from €14.0 million in 2024 to €13.0 million in 2025. The

movement primarily reflects non-cash accounting adjustments associated with the

Company’s debt facility, including the amortization of transaction costs, the application of

the effective interest method, and foreign exchange effects arising from the remeasurement

of the loan balance at the year-end exchange rate. No additional tranches were drawn under

the Runway Growth facility during 2025. Warrants issued in connection with the facility were

recognized as a reduction of the loan balance upon initial recognition, consistent with prior-

year treatment.

Equity

Equity increased by €7 million during 2025, resulting in a closing balance of €55 million and

further strengthening the Company’s capital base and financial flexibility. The increase

was primarily driven by proceeds from equity financing activities, which generated €47.6

million net of transaction costs and supported the Company’s strategic and operational

objectives. This was partially offset by the net loss for the period of €41.8 million. Non-cash

items, including share-based compensation of €2.6 million, also contributed to the increase

in equity, while the remeasurement of post-employment benefit obligations and currency

translation differences resulted in a net decrease of €1.6 million.

Governance

121

ONWARD

Medical Annual Report 2025

General

ONWARD is a public limited liability company established under the laws of the Netherlands,

with common shares listed on Euronext Brussels, Amsterdam and Paris. The Group is

composed of ONWARD Medical N.V. (incorporated as a private limited liability company

(B.V.) on 20 November 2015) and its wholly owned subsidiaries:

•

ONWARD Medical S.A. (Swiss subsidiary established on 12 December 2014)

•

ONWARD Medical Inc. (US subsidiary established on 13 September 2013)

The Company and its subsidiaries act as one company.

ONWARD’s corporate governance is guided by the rules and principles set out in the Dutch

Corporate Governance Code (the DCGC), the requirements of the Dutch Civil Code, the

Company’s Articles of Association (AOA) and any other applicable laws and regulations,

including securities laws. The AOA are available on the ONWARD website

(onwd.com)

under

the Investors/Governance tab

ONWARD maintains a Code of Conduct in order to promote a culture of good governance,

excellence, and consistency that applies to all directors, officers, and employees. A copy of

the Code of Conduct is available on the ONWARD website (onwd.com) under the Investors/

Governance tab. The Code of Conduct outlines our commitment to be a responsible social

partner and the way in which we attempt to interact with our stakeholders, including

shareholders, suppliers, customers, employees, and SCI community. The Code of Conduct

expresses our dedication to an economically, socially, and ethically sustainable way of working.

The Board has received no indications that the Code is not effective or of any non-compliance.

Governance

Governance Framework

The Company’s overall governance framework and key governance elements at each level

are the following:

•

For shareholders: the Articles of Association and Shareholder Dialogue Policy

•

For the Board: the Board Rules, the Charter of the Audit Committee, the Charter of the

Compensation Committee, and the Charter of the Nomination Committee

Board of Directors

ONWARD has a one-tier board consisting of one or more Executive Directors (uitvoerend

bestuurders) and one or more Non-Executive Directors (niet-uitvoerend bestuurders), all of

whom are individuals. Our CEO, as Executive Director, with the support of the Management

Team, is charged primarily with the Company’s day-to-day business and operations and

the implementation of the Company’s strategy. The non-executive Directors are primarily

responsible for supervising the performance of the Executive Director.

In a one-tier governance structure such as that adopted by ONWARD, Non-Executive Directors

and Executive Directors share responsibility for managing the company for those tasks and

duties that are not delegated to one or more other specific Directors by virtue of Dutch law,

the Articles of Association, or any other arrangement catered for therein (e.g., the Rules of

the Board). It is therefore important that the Board ensure sufficient independent supervision

by Non-Executive Directors.

In accordance with the DCGC, the Board’s role is to provide leadership and supervision to the

Company on matters of strategy, risk management, and policies. It has overall responsibility

123

ONWARD

Medical Annual Report 2025

for the management and control of the Company and is authorized to take all actions it deems

necessary to achieve the Company’s purpose.

In performing their duties, Directors must be guided by the best interests of the Company

and its stakeholders, including business partners, employees, and shareholders. The Board

has drawn up Rules concerning its organization, decision-making, and other internal

matters. These Rules are available on the ONWARD website (onwd.com) under the Investors/

Governance tab.

The composition of the Board aims to ensure a broad diversity of experience, knowledge, and

skills. The directors are appointed by the Company’s Annual General Meeting of shareholders

upon nomination by the Board. The general meeting may dismiss a Director at any time by

a two-thirds majority vote if less than half of the issued share capital is represented at the

General Meeting, unless the resolution for dismissal is passed at the Board’s proposal.

Dutch law does not set a limit on the maximum number of consecutive terms that a Director

may serve. According to the DCGC, Non-Executive Directors may be elected for a maximum

of two consecutive four-year terms and, subsequently, for a maximum of two consecutive

two-year terms. Mr. de Koning has served as a Non-Executive Director since 2016 and brings

extensive experience in the life sciences sector through his role at EQT Life Sciences, as well

as prior and current board positions. He was re-appointed in 2024 for a period of four years,

ending at the annual general meeting of shareholders to be held in 2028. In accordance with

best practice provision 2.2.2 of the Dutch Corporate Governance Code, the Board considered

his continued tenure beyond eight years and concluded that his strong knowledge of the

Company, continued contribution and relevant experience support his reappointment and

the effective functioning and continuity of the Board.

The Board meets as often as any Director considers necessary or appropriate. Resolutions

are passed by a simple majority of votes cast. In the case of a tie in the vote of the Board, the

resolution is not passed. Any resolutions concerning a material change to the character or

identity of the Company or its business must be submitted to the Annual General Meeting

for approval.

Composition of the Board of Directors

The Company has a one-tier Board consisting of 8 members.

a: Interim Director (expected to be nominated for appointment at our Annual General Meeting to be held in 2026).

Name

Year of Birth

Nationality

Gender

Position

Year of

First

Appointed

End of Term

Rob ten Hoedt

1960

Dutch

Male

Independent

Non-Executive

Director &

Chairperson

2025

Annual General

Meeting in 2029

Dave

Marver

1968

American

Male

Executive

Director & CEO

2020

Annual General

Meeting of 2029

Ian Curtis

1968

British

Male

Independent

Non-Executive

Director &

Vice-Chair

2019

Annual General

Meeting of 2029

John

de Koning

1968

Dutch

Male

Non-Executive

Director

2016

Annual General

Meeting of 2028

Kristina

Dziekan

1968

German,

Swiss

Female

Independent

Non-Executive

Director

2022

Annual General

Meeting of 2026

Vivian

Riefberg

1960

American

Female

Independent

Non-Executive

Director

2023

Annual General

Meeting of 2027

Rahma Samoa

1979

German

Female

Independent

Non-Executive

Director

2025

Annual General

Meeting in 2029

Tim Denison

1970

American

Male

Independent

Non-Executive

Director

Lucas

Buchanan

1977

American

Male

Independent

Non-Executive

Director

Governance

125

ONWARD

Medical Annual Report 2025

Board Members’ Biographies

Rob ten Hoedt

as a former Executive Committee Member at Medtronic, Rob brings an

impressive track record in technology development and business-model innovation. He was

previously Executive Vice President & President of Global Regions at Medtronic, overseeing

the Americas, EMEA, and Asia Pacific. Rob was Chairman of the Board of MedTech Europe,

the industry association for medical technology in Europe; he is the current Chairman of

Medmix in Switzerland, and serves on the boards of Fagron International and NLC Health. Rob

holds a degree in Commercial Economy from H.E.A.O., and a Master’s in Marketing from NIMA

Business School in the Netherlands. Rob is the Board Chair, a Member of the Compensation

Committee and the Nomination and Corporate Governance Committee.

Dave Marver

(CEO) is an accomplished chief executive and director with 30 years’

international experience in public, private, and emerging companies. He combines expertise in

medical and consumer technology, wearables, and health monitoring. Previously, Dave spent

almost 15 years with Medtronic, holding a variety of leadership positions in the US and Europe,

including vice-president roles in sales, marketing, strategy, and business development. He

then joined Nasdaq-listed Cardiac Science Corporation as CEO before co-founding two

startups. He holds a BA in psychology from Duke University and an MBA from University of

California, Los Angeles.

Ian Curtis

is a director of SCI Ventures, a venture capital firm that invests in companies

focused on treatments for paralysis. He is a member of the board of the Christopher & Dana

Reeve Foundation and the International Spinal Research Trust. Ian is also the chairman of

HPC plc, a UK-based engineering company. He is a graduate of Durham University, a fellow

of the Institute of Chartered Accountants in England and Wales, and a former partner with

PwC. Ian is the Board Vice-Chair and Chair of the Audit Committee.

John de Koning

is a General Partner at EQT Life Sciences (formerly LSP), one of the largest

European investment firms providing financing for life sciences and healthcare companies.

Since joining EQT in 2006, John has led some of its most successful investments and served

on the board of several companies, including argenx, Merus, and Prosensa. He holds an MSc

in medical biology from the University of Utrecht and a PhD in oncology from the Erasmus

University Rotterdam.

Kristina Dziekan

is Head of Global Access, Value and Economics, Europe at Intuitive and

has been a senior advisor in market access, market development, and policy for life sciences

companies. She previously served in leadership roles as Head of Market Access, Government

Affairs, and Tendering for Alcon’s Surgical Division in Europe,Senior Global Reimbursement

and Health Economics Director for Medtronic Neuromodulation, and Health Outcomes

Manager for GlaxoSmithKline in the UK and parts of Asia. She earned an MSc in Health

Policy, Planning, and Financing from the London School of Economics, an MA in International

Economics and European Studies from Johns Hopkins University, a BA in Philosophy, Politics,

and Economics from Oxford University.

Kristina is a Member of the Audit Committee.

Vivian Riefberg

is currently the David C. Walentas Jefferson Scholars Chair Professor of

Practice at the Darden School of Business at the University of Virginia and serves on the

boards Waystar (WAY:Nasdaq), K Health, Accompany Health and Lightrock, an impact

investing firm, as well as the boards of the Public Broadcasting System (PBS), Johns Hopkins

Medicine, and the National Education Equity Lab. She is also an advisory board member for

the Smithsonian’s planned American Women’s History Museum. She retired from McKinsey

& Company in 2020 after 31 years, having served as co-leader of the US healthcare practice,

leader of the public sector practice in the Americas, and on McKinsey’s global board of

directors. She previously served on the US National Institutes of Health (NIH) Clinical Center

Board of

Governors and the NIH Advisory Board for Clinical Research. She holds a BA, magna

cum laude in history from Harvard-Radcliffe College and an MBA with distinction from Harvard

Business School. Vivian is Chair of the Compensation Committee and Chair of the Nomination

and Corporate Governance Committee.

Rahma Samow

is currently President and CEO of ClearChoice Dental Implant Centers, a

US-based provider of dental implant therapy and tooth replacement services with over 2,000

employees. Prior to ClearChoice, she served on the Executive Management Board of the

Swiss-based Straumann Group. She also had a 15-year career with Siemens Healthineers,

where she held various roles in sales, marketing, and communications in their digital health

business, with geographic responsibilities spanning the US, Germany, Middle East, and Africa.

Ms. Samow holds a Diploma in Medical Radiology, Radiation Therapy, and Nuclear Medicine

Technology from the Medical University of Bonn, Germany. Rahma was a Member of the Audit

Committee until Q3 of 2025.

Governance

127

ONWARD

Medical Annual Report 2025

Professor Tim Denison

holds a Chair in Emerging Technologies by the Royal Academy

of Engineering at the University of Oxford, where he is Professor of Engineering Science

and Clinical Neurosciences. Denison was formerly Vice President of Research & Core

Technology for the Restorative Therapies Group at Medtronic, where he helped oversee the

design of next-generation neural interface and algorithm technologies for the treatment of

neurological disorders. Denison is a Fellow of both the American Institute of Medical and

Biological Engineering and the Royal Academy of Engineering. He is also Co-Founder and

Chief Engineer at Amber Therapeutics, a neurotechnology company pursuing solutions for

urinary incontinence. Denison received an AB in Physics from the University of Chicago, and

an MS and PhD in Electrical Engineering from MIT. He also completed an MBA as a Wallman

Scholar at the University of Chicago.

Lucas Buchanan

brings over 25 years of expertise in commercialization, operations, business

development, investing, and finance. As the CCO and CFO at Silk Road Medical, he helped

lead the company from its founding through to its IPO in 2019 and ultimate sale to Boston

Scientific in 2024. Lucas previously held roles at The Vertical Group, Impax Laboratories,

Warburg Pincus, Medtronic, and Ernst & Young. Lucas is an active investor who currently

serves on the Boards of Directors for several medical technology companies. He holds a BA in

Economics from Duke University and an MBA in Health Care Management from The Wharton

School at the University of Pennsylvania. Lucas joined as a Member of the Audit Committee

in Q3 2025.

Director independence

In accordance with best practice provision 2.1.7 of the DCGC, the majority of the Non-Executive

Directors must be independent; at most, one Non-Executive Director does not have to meet

the independence criteria. A Board member is considered “not independent” if he or she,

a spouse, partner, or close family member (related by blood or marriage up to the second

degree) meet any of the conditions listed below:

•

Has been an employee or member of the management board of the Company, including

associated companies (as referred to in Section 5:48 of the Financial Supervision Act

Wet op het financieel toezicht/ Wft

) in the five years prior to their appointment.

•

Receives personal financial compensation from the Company, or an associated company,

other than the compensation received for the work performed as a Board member.

•

Has had an important business relationship with the Company or an associated company

in the year prior to the appointment.

•

Is an executive of a company in which a member of the management board of the

company which he supervises is a non-executive Board member.

•

Has temporarily performed management duties during the previous twelve months in

the absence or incapacity of a member of the management board.

•

Has a shareholding in the Company of at least 10%.

•

Is a member of the management board or supervisory board, or a representative in some

other way, of a legal entity that holds at least 10% of the shares in the company, unless the

entity is a group company.

At the date of this Annual Report, the Board consists of nine members, of whom eight are Non-

Executive Directors. Only one Non-Executive Director is deemed “not independent” based

on meeting certain of the conditions above. John de Koning is considered “not independent”

as he is a representative of a major shareholder in the Company (EQT Group (formerly LSP)).

The requirements for independence as per best practice provision 2.1.7 of the DCGC are met.

Committees within the Board of Directors

The Board has established the following three committees:

•

the Audit Committee

•

the Compensation Committee

•

the Nomination and Corporate Governance Committee

Non-Executive Directors are appointed to committees by the Board. The committees report

their findings to the Board, which is ultimately responsible for all decision-making. The role,

responsibility, and functioning of each committee is summarized below.

Governance

129

ONWARD

Medical Annual Report 2025

Audit Committee

The Audit Committee comprises three members: Ian Curtis (Chair), Kristina Dziekan, Rahma

Samow (up to Q3 2025) and Lucas Buchanan (since Q3 2025).

In accordance with its charter, the Audit Committee is charged with the following matters:

Monitoring the Board with respect to:

•

relations with the internal audit function and the external auditor, as well as

compliance with recommendations and follow-up of comments

•

the Company’s funding

•

the application of information and communication technology by the Company,

including risks relating to cybersecurity

•

the Company’s tax policy

Issuing recommendations concerning the appointment and the dismissal of the head of

the internal audit function, as relevant, and reviewing and discussing the performance of

the internal audit function.

ONWARD has not yet established a separate internal audit function and the related

responsibilities as per the charter do not apply.

Reviewing and discussing the Company’s audit plan, including with the internal audit

function and the external auditor.

Reviewing and discussing the essence of the audit results, also with the internal audit

function, including:

•

flaws in the effectiveness of the Company’s internal risk management and control

systems (“Internal Controls”)

•

findings and observations with a material impact on the Company’s risk profile

•

failings in the follow-up of recommendations made previously by the internal

audit function

Monitoring the audit of the Company’s annual accounts, annual report, and financial

reporting processes, and making proposals to safeguard the integrity of these processes.

Reviewing and discussing the effectiveness of the design and operation of the Internal

Controls with the Board, the CEO, and the CFO, including identified material failings in

the Internal Controls and material changes made to, and material improvements planned

for, the Internal Controls.

Reviewing and monitoring the independence of the external auditor, also considering

any non-audit services rendered by the external auditor.

Submitting proposals to the Board concerning the external auditor’s engagement to audit

the Company’s financial statements, including the scope of the audit, the materiality

standard to be applied, and the external auditor’s fees.

The members of the Audit Committee are appointed and dismissed by the Board. More than

half of all its members, including the chairperson, must be independent within the meaning

of the DCGC and at least one committee member must have competence in accounting

and/or auditing.

The Audit Committee shall meet as often as it determines is appropriate to carry out its

responsibilities and each meeting shall be presided over by the chairperson and, in the

absence of the chairperson, one of the other members shall be designated as the acting

chairperson of the meeting.

Compensation Committee

The Compensation Committee comprises three members: Vivian Riefberg (Chair), Ian Curtis,

and Rob Ten Hoedt. .

In accordance with its charter, the Compensation Committee is charged with the

following matters:

Submitting proposals to the Board concerning changes to the Company’s

compensation policy.

Governance

131

ONWARD

Medical Annual Report 2025

Submitting proposals to the Board concerning the compensation of individual

Directors, covering:

•

compensation structure

•

amount of the fixed and variable compensation components

•

applicable performance criteria

•

scenario analyses that have been carried out

•

pay ratios within the Company’s group

•

views of the Director concerned regarding the amount and structure of his or her

own compensation

The preparation of the Company’s compensation report for the Board.

Nomination and Corporate Governance Committee

The Nomination and Corporate Governance Committee comprises three directors: Vivian

Riefberg (Chair), Ian Curtis, and Rob Ten Hoedt.

In accordance with its charter, the Nomination and Governance Committee is charged with

the following matters:

Drawing up selection criteria and appointment procedures for the Directors.

Reviewing the size and composition of the Board and submitting proposals for the

composition profile of the Board.

Reviewing the functioning of individual directors and reporting on such reviews to the Board.

Drawing up a plan for the succession of directors.

Submitting proposals for (re)appointment of directors.

Supervising the policy of the Board regarding the selection criteria and appointment

procedures for the Company’s senior management and executive officers

Management Team

The Management Team is responsible for running the Company in accordance with the

strategies, policies, and budgets determined by the Board. It has all powers except for those

reserved for the Board and the General Meeting of shareholders by law and by the Company’s

Articles of Association.

The members of the Management Team commit to carrying out their duties in accordance

with the highest business, ethical, moral, and legal standards laid out in the Company’s Code

of Business Conduct and Ethics (see onwd.com, Investors/Governance). They strive to lead by

example by embodying the ONWARD code of values in everything they do. The Management

Team meets at least once a week.

Name

Position

Member Since

Dave Marver

Chief Executive Officer

2020

Ali Kiboro

Chief Financial Officer

2026

Shari O’Quinn

Chief Clinical, Regulatory &

Quality Officer

2025*

Sean Sciara

Chief Commercial Officer

2025

Robert Odell

VP Operations

2023

Julien Camisani

VP Engineering

2024

Lorenzo Fanti

VP Legal

2024

Sébastien Cros

VP Communications

2025

Governance

133

ONWARD

Medical Annual Report 2025

Amori Fraser

Finance Director

2024

Julie Crom

Director: People & Culture

2024

Alexandre Casteau

Head of Strategy & Corporate

Development

2024

Biographies of the Management Team

Dave Marver

(see biography

125

Ali Kiboro

joined ONWARD as Chief Financial Officer in January 2026 and brings over 25 years

of experience across MedTech, global healthcare, diagnostics and industrial organizations.

Ali previously served as the Chief Financial Officer at AliveDx where he led financial strategy,

capital markets and operational transformation. He raised over $200 million across public

and private markets and worked closely with boards, investors, and lenders to drive long

term value creation. Prior to AliveDx, Ali served in a variety of senior finance leadership roles

at Quest Diagnostics and General Motors. Ali holds an MBA in Finance from The Wharton

School of the University of Pennsylvania and a BSc. in Finance, summa cum laude, from

Duquesne University.

Shari O’Quinn

is an accomplished executive with more than 25 years of leadership experience

building and scaling Clinical, Regulatory, Quality, Medical Affairs, and Health Economics

functions into strategic drivers of innovation and business growth. She brings deep

expertise in Class II and Class III medical devices, global approval pathways, and evidence-

based commercialization across all major regions. Shari has held senior roles at W.L. Gore,

TriVascular, Endologix, and C.R. Bard. She holds a B.A. from the University of Virginia.

Sean Sciara

is a seasoned global executive with over 25 years of experience in commercial

and general management roles in the medical device industry.

He brings deep expertise

across global product launches, product management, sales management, and portfolio

planning and has successfully launched over 40 products in his career spanning single

use devices, active implantable devices, capital equipment, and software.

Prior to joining

ONWARD, Sean held senior marketing and sales leadership positions at Guidant, Greatbatch

Medical (now part of Integer Holdings), and most recently Boston Scientific where he held

several VP level roles including Vice President of Global Marketing for one of the company’s

fast growing strategic divisions. Sean holds a Bachelor of Science in Electrical Engineering

from Carnegie Mellon University and an MBA from the University of Minnesota.

Robert Odell

brings to ONWARD decades of technology and leadership experience in the

medical device industry. Prior to joining ONWARD, Robert was President and Chief Operating

Officer of Cardiac Insight, Inc., a successful startup that created and introduced disruptive

cardiac monitoring technology. Prior to Cardiac Insight, he served as COO for Cardiac Science,

a publicly traded manufacturer of Class II and Class III devices. Robert has held executive

assignments in Operations, Engineering, Marketing, Business Development, Information

Technology, and QA/RA with such notables as GE Healthcare, Siemens Medical Solutions,

Philips Medical Systems, Medtronic, and Analogic. The foundation for his career is a degree

in electrical engineering from Syracuse University.

Julien Camisani

brings more than twenty years of experience, fifteen of which are in the life

sciences industry, where he has been instrumental in inventing, developing, marketing, and

sustaining advanced laboratory, medical and bio-manufacturing technologies. Prior to joining

ONWARD

Medical, Julien led diverse and global teams, and managed large-scale projects

with proven leadership across research and development, manufacturing, intellectual property

and product management for companies like Cytiva, GE Healthcare and Biosafe. He holds

dual master’s degrees in Embedded Systems from the University of Lugano, collaborating

with ETH Zurich and Politecnico di Milano, complemented by an MBA from the University of

Cumbria and a professional certificate in Technology Road mapping and Strategic Innovation

from MIT.

Lorenzo Fanti

is a dual-qualified US and English attorney with 15 years of experience

specializing in pharmaceuticals and medtech. Prior to joining ONWARD Medical, Lorenzo

served as worldwide Legal Head, Ophthalmology ad interim at Novartis Pharmaceuticals,

and, prior to that, he was Country Legal Head for Chile ad interim for the Novartis group of

companies. He has held various roles with increasing responsibility at Novartis, including

Governance

135

ONWARD

Medical Annual Report 2025

in the Neuroscience franchise, where he contributed to the launch of innovative migraine

treatments. Early in his career, he was a Trademark Paralegal with Sandoz, and he trained

with Allen & Overy LLP in London. He holds an LL.B. from the University of Wales.

Sébastien Cros

brings extensive experience in global communications across both private

and public healthcare companies. Prior to joining ONWARD Medical in May 2025, Sébastien

served as Global Head of Corporate Communications at Galderma, the dermatology category

leader that went public in 2024. Over the course of 15 years, he held roles of increasing

responsibility at Galderma and Nestlé’s skin health division, where he successively led global

teams in media relations, public affairs, financial communications, transformation and

employee engagement, issues and crisis management, global congresses and events, and

digital. Earlier in his career, he served as digital marketing and economic intelligence project

lead at Servier International. Sébastien holds a Doctor of Pharmacy (PharmD) degree from

the University of Montpellier, France, and an LLM in Intellectual Property.

Amori Fraser

serves as the Finance Director at ONWARD Medical, leveraging over 20 years

of experience in both finance and auditing. Prior to her current role, she worked as a Senior

Manager at EY, specializing in financial reporting, regulatory compliance, financial analysis

and internal controls serving multi-national listed groups. Amori’s experience in auditing and

finance enables her to drive efficient financial operations and support the company’s growth

initiatives. Amori holds a BComHons degree in Accounting Sciences from the University of

Pretoria and is a qualified Chartered Accountant (CA) with the South African Institute of

Chartered Accountants (SAICA).

Julie Crom

has more than 10 years of experience in Human Resources in the medical devices

industry. Prior to joining ONWARD Medical, Julie served as Healthcare & Life Sciences Practice

Lead at Michael Page, a leading recruitment company in Europe. In her role, she supported

middle-to-large medical device companies in recruitment and organizational strategy. Julie

holds an MSc in International Business Management from INSEEC business school.

Alexandre Casteau

brings extensive healthcare corporate strategy expertise. A former

management consultant with McKinsey & Company, Alexandre spent several years advising

global life science businesses on growth strategy and large-scale transformations. He

also launched and led the McKinsey Switzerland startup/scaleup service line, providing a

differentiated strategy consulting offering to help early-stage, fast-growing companies scale.

Earlier in his career, Alexandre held a variety of roles at Endeavor, Rocket Internet SE and

Société Générale Corporate & Investment Banking. He holds an MBA from INSEAD and an

MSc. from MIT.

Uniqueness & Opportunity

ONWARD believes that diverse perspectives, backgrounds, and life experiences contribute

to stronger decision-making and better governance. The Company is committed to

fostering, valuing and benefiting from fair opportunity principles. The Company endeavors

to act in line with the spirit and objectives of best practice provisions 2.1.5 and 2.1.6 of the

Dutch Corporate Governance Code. Diversity and inclusion principles are embedded in the

Company’s governance practices, leadership approach, recruitment processes, and Code

of Conduct, which promotes professionalism, respect, fairness, and a socially safe working

environment.

Although no formal numerical targets have been adopted, ONWARD’s ambition remains

for both the Supervisory Board and the Management Team to include at least one-third

female representation, alongside a balanced mix of professional expertise, international

experience,

age

profiles,

and

perspectives

relevant

the

Company’s

stage

development and strategy. The Company promotes fair opportunity across the full

employment lifecycle, including recruitment, compensation, career progression, leadership

representation, working conditions, retention and access to development opportunities.

As at year-end 2025, ONWARD’s Board comprised nine members, including six male

directors

(one executive director) and three female directors (all non-executive). The

Management

Team consisted of eleven members, of whom eight were male and three

female. ONWARD’s ongoing recruitment and succession efforts for both Board and

management roles continue to emphasize independence, diversity of background, and

broad representation.

Governance

137

ONWARD

Medical Annual Report 2025

Stakeholder dialogue

The Company has drawn up an outline policy for effective dialogue with stakeholders. The

company is prepared to engage in a dialogue and will facilitate this dialogue unless, in the

opinion of the Board and Management Team, this is not in the interests of the Company and

its affiliated enterprise. This policy is available on our

website

Conflicts of Interest

According to principle 2.7.4 of the DCGC, the Company must report on directors’ conflicts of

interest in transactions in its management report where the conflict of interest is of material

significance to the Company or to the relevant director. Directors and members of management

are expected to arrange their personal affairs so as to avoid conflict of interest. Any potential

conflict of interest must be brought to the attention of the Board.

Certain directors and members of the Management Team have a direct or indirect beneficial

interest in ONWARD’s share capital or serve as a representative of a legal entity that is a major

shareholder. In their capacity as non-executive directors, their primary duty is to supervise the

performance of the executive directors and the management of the Company and its business.

A conflict of interest may arise if a decision aimed at contributing to the Company’s long-term

and sustainable success negatively impacts its share price in the short term, thereby reducing

the value of the shareholding of which the non-executive director is a representative.

As of 31 December 2025, the potential conflicts of interests between the duties to the Company

of each of the directors and members of the Management Team and their private interests or

other professional duties were as follows:

John de Koning represents EQT, a major shareholder of the Company and Non-Executive

Director of the Company.

No transactions that would result in a conflict of interest were reported to the Board in 2025.

https://ir.onwd.com/corporate-governance

Related Party Transactions

ONWARD’s policy on related party transactions is designed to comply with the applicable

provisions of the Dutch Civil Code (DCC) and the recommendations of the Dutch Corporate

Governance Code. The Dutch act implementing the EU Shareholder Rights Directive II

(Bevordering van de langetermijnbetrokkenheid van aandeelhouders, the “Dutch SRD Act”),

which entered into force on 1 December 2019, introduced additional requirements in the DCC

relating to related party transactions. Under these provisions, material transactions with

related parties that are not entered into in the ordinary course of business or not concluded

on arm’s length terms require prior approval by the Board and must be publicly disclosed at

or before the time the transaction is entered into.

In accordance with these requirements, the Board has established internal procedures to

periodically assess whether transactions with related parties are conducted in the ordinary

course of business and on normal market terms. In particular, transactions between ONWARD

and shareholders holding 10% or more of the issued share capital are required to be entered

into on customary terms. Any transaction of material significance to the Company and/

or the relevant shareholder would require Board approval and disclosure in the Company’s

management report, together with a statement confirming compliance with the applicable

governance requirements.

No related party transactions meeting the criteria for disclosure under the DCC or the Dutch

SRD Act occurred or were reported to the Board during the 2025 financial year.

General Meeting

The main powers of the General Meeting relate to:

•

the issuance of shares or rights to shares, restriction, or exclusion of pre-emptive rights

of shareholders, repurchase of shares, and reduction of the issued share capital

•

the amendment of the Articles of Association

•

the appointment, suspension, and dismissal of members of the Board

Governance

139

ONWARD

Medical Annual Report 2025

•

decisions of the Board involving a significant change in the Company’s identity of character

•

the approval of the remuneration policy of the Board

•

the adoption of the financial statements and declaration of dividends

•

the appointment of the Company’s external auditor

The Annual General Meeting is held within six months after the end of the financial year to

discuss and, if applicable, approve, the Annual Report, the Annual Accounts, and any of the

other topics mentioned above.

The Annual General Meeting and, if necessary, other General Meetings, are convened by the

Board. The agenda and explanatory notes are published on the Company website.

The last Annual General Meeting was held on 11 June 2025. The agenda, explanatory notes

and minutes are published on the Company website. The date of the next Annual General

Meeting will be announced after publication.

Deviations from the Best Practices Provisions of the Dutch Corporate Governance Code

ONWARD acknowledges the importance of good governance and is committed to adhering

to the best practices of the DCGC as much as possible. As of the date of this Annual Report,

we report the following deviations from the DCGC:

•

Best practice provision 2.1.5. and 2.1.6

In deviation from best practice provisions 2.1.5 and

2.1.6 of the DCGC, ONWARD has not yet formalized its diversity and inclusion ambitions,

objectives, and implementation plan in a dedicated policy, nor has it established

specific, measurable targets across all organizational layers. This reflects the Company’s

current scale, international footprint, and focus on operational execution during a period of

transition to commercialization. Notwithstanding the absence of a formal policy, ONWARD

believes it is substantively meeting the intent of the Code through its governance practices,

leadership culture, recruitment decisions, and commitment to fairness. The

Company

continues to periodically assess whether and when further formalization of its

framework would be appropriate and value-adding, taking into account its evolving

organizational needs and regulatory environment.

•

Best practice provision 3.1.2 v

The DCGC recommends that variable remuneration

should be linked to measurable performance criteria determined in advance. To align the

employees’ interest with the interests of the shareholders and to allow the participation

in the long-term growth of the Company, options were granted to the Management Team

(including the Executive Director). There is no specific performance conditions associated

to these options, only a service condition. However, considering that the value of the option

is linked to the share price of ONWARD, it includes an inherent performance criterion.

Furthermore, the size of the stock option is linked to the position and job grade of the

individual and is contingent on the performance of the individual. We will consider if more

clear measurable performance criteria should be added to future grants.

•

Best practice provision 3.3.3.

The DCGC recommends that shares held by a non-

executive director in the company on whose Board of Directors they serve should be held

as a long-term investment. The Company’s Compensation Policy does not include such

a requirement.

•

Best practice provision 4.3.3.

The DCGC recommends that the General Meeting should be

capable of passing a resolution cancelling the binding nature of a nomination or dismissal

by simple majority, representing no more than one-third of the issued share capital.

Under the Articles of Association, directors can only be appointed or dismissed by the

General Meeting by simple majority of votes cast, provided that the Board proposes the

appointment or dismissal. In other cases, the General Meeting can only pass a resolution

to appoint or dismiss a director by a two-thirds majority representing more than half of

the issued share capital. The Company deems this appropriate considering the remaining

shareholdings and involvement of the Company’s current significant shareholders.

Governance

Risk

Management

& Control

143

ONWARD

Medical Annual Report 2025

Risk Management

& Control

Effectively identifying, assessing, and managing internal and external risks is critical to

achieving our strategic objectives, ensuring the reliability of our financial reporting, and

maintaining compliance with all applicable laws and regulations. Our primary risk areas

remain focused on the research and development of ARC Therapies, securing regulatory

approvals for future indications, protecting intellectual property, and ensuring the Company’s

financial stability in the mid- to long-term. In addition, management periodically assesses

risks related to fraud and misconduct, including risks that could impact the integrity of

financial reporting.

The Management Team is responsible for developing, implementing, and maintaining robust

risk-management and internal control systems, while the Board provides oversight of these

processes. These systems are continuously reviewed, expanded and refined based on the

stage and growth of the Company, internal evaluations, discussions with the Board and Audit

Committee, and external audits. Fraud risk considerations form part of these evaluations and

are discussed with the Board and Audit Committee as appropriate.

The findings from our 2025 annual risk review are reflected in this report. During 2025,

management continued to operate and further embed the Company’s internal control

framework, which is designed to provide reasonable assurance over the reliability of

financial reporting and the preparation of financial statements in accordance with IFRS.

Management performed a self-assessment of the system of internal control with reference

to the key components of internal control, taking into account the Company’s current stage

of development and increasing commercial activities. As part of this process, management

also performed an annual fraud risk assessment to identify and evaluate potential fraud risks

relevant to the Company’s operations and financial reporting.

145

ONWARD

Medical Annual Report 2025

The assessment confirmed that the framework remains appropriate and proportionate, while

also identifying areas for ongoing enhancement as the business evolves, including in response

to increased transaction volumes, inventory levels, and revenue arrangements following

FDA clearance and initial commercialization. Management continues to refine controls and

documentation where needed and to address identified financial statement and fraud risks

through targeted mitigating actions, supported by Board and Audit Committee oversight.

Key areas considered in the fraud risk assessment included revenue recognition, inventory

existence, and management override of controls, which are addressed through documented

policies, review procedures, and oversight controls.

As ONWARD progresses further into its commercial phase, the internal control framework

will continue to be reviewed and updated to reflect changes in processes, systems, and risk

profile, with a focus on maintaining robust governance while scaling efficiently. The Company

is in the early stages of developing processes related to sustainability information.

Since ONWARD does not have a dedicated internal audit function, the Board conducts an

annual review to determine whether alternative measures are sufficient. Based on the Audit

Committee’s recommendation, Directors may evaluate the necessity of establishing an

internal audit function. In 2025, no deficiencies in our risk-management and control systems

were identified that would result in a material misstatement in the financial statements.

While these systems strengthen our ability to achieve strategic goals and regulatory

compliance, they cannot provide absolute assurance against all risks, misstatements, or

instances of non-compliance. This includes the risk of fraud or management override of

controls. We remain committed to continuously enhancing our approach to risk management

and internal controls to support the long-term success of the Company.

Risk Control Matters

The Company has implemented a risk detection, evaluation, and management system tailored

to its size, operations, and growth stage. The Board and Management Team continuously

assess potential risks, evaluate their financial impact and likelihood, and take proactive

measures to mitigate them. Risk assessments are updated in response to evolving internal

and external conditions. This includes an annual fraud risk assessment process through which

identified risks and mitigating actions are documented in the Company’s risk register.

The Board and Management Team meet regularly to review developments, set strategic

objectives, and track progress toward key milestones. These meetings also include

assessments of ONWARD’s financial position, as well as the presentation and review of

budgets and cash flow forecasts, which are continuously monitored and adjusted as needed.

The Management Team remains vigilant in identifying and addressing emerging risks,

adapting strategies, and implementing necessary countermeasures as required.

To effectively manage business risks, we leverage a combination of highly experienced

internal experts and external consultants for research and clinical studies. Study results

are closely and systematically monitored, allowing for timely responses to new findings and

adjustments to preclinical and clinical activities as needed. Regular internal budgeting and

financial monitoring enable early detection of deviations from financial plans, allowing for

swift corrective actions.

Given our reliance on third parties to meet regulatory requirements and uphold quality

standards, we apply a rigorous selection process when engaging contractors. The

Management Team carefully evaluates and selects major clinical trial and component service

providers based on their quality and expertise. We continuously review the performance of

these partners to ensure alignment with our operational and compliance expectations.

To protect and monitor our intellectual property (IP), we collaborate exclusively with highly

specialized consultants and legal experts. The Management Team also conducts ongoing

reviews of patent protections and potential conflicts to safeguard our innovations.

In our financial reporting process, our risk-management and internal control systems are

designed to ensure the accuracy and integrity of our financial data. These systems provide

reasonable assurance that transactions are recorded correctly, financial reporting complies

with legal and regulatory standards, and published financial statements are free from material

misstatements. Additionally, controls are in place to ensure that receipts and expenditures

are authorized and that assets are adequately safeguarded.

To manage risks related to valuation uncertainties, we engage specialists with the necessary

expertise to support financial reporting valuations, including the assessment of defined

benefit obligations and the fair value of options granted.

Risk Management & Control

147

ONWARD

Medical Annual Report 2025

As part of our internal control framework, we have adopted various policies and procedures,

including standard operating procedures, a dual-control principle, spot checks, automated

expense reimbursement tools, internal contract approval processes, and clearly defined

signatory rules. Together with management review controls and procedures for reporting

concerns, these measures support the prevention and detection of fraud and other

irregularities and help ensure compliance with governance standards. The Board and

management periodically review the design and effectiveness of these controls. Where

the size of the organisation limits full segregation of duties, compensating oversight and

governance measures are applied.

Risk Appetite

Our risk appetite differs according to the various risk categories ONWARD is exposed

to, namely:

•

Risks related to our business, strategy and industry

include adverse, unexpected

developments resulting from internal processes, people, and systems or from our external

research partners and external events, which are linked to the operation of the business.

We are prepared to take moderate risks to achieve our ambitions and to balance risk and

long-term reward.

•

Risks related to legal and government regulation

relate to unanticipated failures to comply

with applicable laws and regulations. We aim to minimize these risks by aiming to comply

fully with these laws and regulations.

•

Risks related to intellectual property.

We aim to minimize these risks, only accepting a low

level, to ensure that intellectual property is protected.

•

Risks related to our financial position, need for additional capital, and taxation

occur

in connection with funding, treasury, tax, accounting, and reporting. ONWARD is prudent

with respect to these financial risks, with the aim of maintaining long-term solvency. We are

committed to transparent and truthful accounting and reporting that allow users of financial

statements to make decisions considering these risks. We currently do not engage in any

hedging activities. Our financial risk management is set out in note 4.3 of our consolidated

financial statements.

Description of the Principal Risks Associated with the Company’s Activities

A key risk for the Company remains the ability to obtain and maintain regulatory approvals

across relevant jurisdictions and indications. While FDA clearance and CE mark have been

achieved for one product, regulatory requirements continue to apply to additional indications,

markets, and lifecycle changes, and delays or changes in regulatory expectations could affect

timelines or costs. As the Company has entered its initial commercial phase, its risk profile

has evolved to include risks associated with market adoption, reimbursement dynamics,

and the execution of commercialization activities. The success of these efforts depends

on the acceptance of the Company’s products by clinicians and patients, the availability of

appropriate reimbursement pathways, and the Company’s ability to scale manufacturing

and supply chain operations in a controlled and compliant manner while maintaining quality

and performance standards.

To proactively manage regulatory risks, ONWARD relies on a dedicated and skilled regulatory

team, maintains continuous engagement with regulatory bodies, and works closely with third-

party suppliers to mitigate potential quality issues.

The following section outlines the primary risks and uncertainties that we consider significant

threats to achieving our objectives. These risks may impact the Company’s future operational

and financial performance, as well as the value of an investment in the Company’s securities.

Additional risks and uncertainties, including those not currently known or considered

immaterial at this time, could also adversely affect our business, financial condition, results of

operations, and growth prospects. If any of these risks materialize, the price of the Company’s

securities may decline, potentially resulting in partial or total investment loss.

While this list highlights key risk factors, it is not exhaustive, as unforeseen contingencies

may arise that could further impact our business.

Risks related to the Company’s business, strategy & industry

The Company partially depends on the success of two investigational devices, the ARC

and ARC

BCI

platforms. Even if the Company completes clinical development and obtains

favorable clinical results for the initial indications it is pursuing, it may not be able to

obtain regulatory clearance or approval for, or successfully commercialize, its ARC

and

ARC

BCI

platforms.

Risk Management & Control

149

ONWARD

Medical Annual Report 2025

ONWARD currently has two investigational devices in clinical development — the ARC

and ARC

BCI

platforms — and our business depends almost entirely on the successful clinical

development, regulatory clearance or approval, and commercialization of these investigational

devices, which may never occur. We currently have one product available for sale, that will

generate revenues from sales of products, but this is our first product to commercialize and

subject to risks of market acceptance, manufacturing as included in this report.

Our ARC

platform will require substantial additional clinical development, testing,

manufacturing process development, and regulatory clearance or approval before we are

permitted to commence their commercialization. For example, before obtaining Premarket

Approval (PMA) approval from the FDA for our ARC

platform, we must show, among other

things, that the product is safe and effective for use in each target indication, a process that

can take many years.

Of the substantial number of medical devices in development in the US, only a small percentage

successfully complete the regulatory clearance or approval process required by the FDA

and become commercialized. Similarly, many medical devices currently in development

will ultimately not obtain the certificate of conformity required for commercialization in the

European Economic Area (EEA). Therefore, even if we obtain the requisite capital to continue

funding our development and clinical programs, we may be unable to successfully develop or

commercialize our ARC

and ARC

BCI

platforms or any other product candidate.

Enrollment and retention of patients in clinical trials is an expensive and time-consuming

process and could be made more diﬃcult, or rendered impossible, by multiple factors

outside the Company’s control. This could signiﬁcantly delay the completion of such trials

or may cause the Company to abandon one or more clinical trials.

ONWARD may encounter delays or difficulties in enrolling — or may be unable to enroll — a

sufficient number of patients to complete any of its clinical trials on its current timelines, or

at all. Even once candidates are enrolled, the Company may be unable to retain a sufficient

number of patients to complete any of its trials.

Patient enrollment in clinical trials, and completion of patient follow-up, depend on many

factors, including the size of the patient population, the nature of the trial protocol, the

proximity of patients to clinical sites, eligibility criteria for the clinical trial, patient compliance,

competing clinical trials, and clinicians’ and patients’ perceptions as to the potential

advantages of the product being studied in relation to other available therapies, including

any new treatments that may be cleared or approved for the indications we are investigating.

Patients may be discouraged from enrolling in ONWARD’s clinical trials if the trial protocol

requires them to undergo extensive post-treatment procedures or follow-up to assess the

safety and effectiveness of a product candidate, or they may be persuaded to participate in

contemporaneous clinical trials of a competitor’s product candidate. Patients participating

in our clinical trials may drop out before completion of the trial or experience adverse medical

events unrelated to the products. Delays in patient enrollment, or failure of patients to continue

participating in a clinical trial, may delay commencement or completion of the clinical trial,

increase in the costs of the clinical trial, or result in failure of the clinical trial.

Since some of the indications that our investigational devices are intended to treat are

limited, ONWARD expects only a subset of patients with spinal cord injury (SCI) to be eligible

for its clinical trials. The protocols for our clinical trials generally mandate that a patient

cannot be involved in more than one clinical trial for the same indication. Therefore, subjects

who participate in ongoing clinical trials for products that compete with our investigational

devices are not eligible to participate in our clinical trials. ONWARD cannot guarantee

that any of its programs will identify a sufficient number of patients to complete clinical

development, pursue regulatory clearance or approval, or market its investigational devices,

if cleared or approved.

An inability to recruit and enroll a sufficient number of patients for any of its current or

future clinical trials would result in significant project delays, or may require us to abandon

one or more clinical trials altogether, which could impact ONWARD’s ability to develop its

investigational devices and may have a material adverse effect on its business, results of

operations, and financial condition.

The ARC

system and, if approved, the ARC

and ARC

BCI

systems, will require market

acceptance to be successful. Failure to gain market acceptance would impact the

Company’s revenues and may materially impair its ability to continue its business.

Risk Management & Control

151

ONWARD

Medical Annual Report 2025

Even after receiving regulatory clearances or approvals (like for ARC

), the commercial

success of our products will depend in part on their acceptance by critical stakeholders as

a therapeutic and cost-effective alternative to competing products and treatments for people

with SCI. Critical stakeholder to adopt our therapies include medical professionals working in

the rehabilitation clinic setting ( such as physicians, physical therapies, occupational therapies,

neurologists, and physiatrists), functional neurosurgeons, patients, third-party payors such

as health insurance companies, and other members of the medical community. There can be

no assurance that medical professionals, hospitals, and rehabilitation clinics will adopt the

use of ARC

and ARC

and establish training and procedures to implement them. Market

acceptance of, and demand for, any product we may develop and commercialize will depend

on many factors, both within and outside of our control. Payors may view new or recently

launched products, or products where limited clinical data is available, as investigational,

unproven, or experimental, and on that basis may deny coverage of procedures involving use

of these products or require additional clinical trials and data before providing coverage. If

our investigational devices fail to gain market acceptance, ONWARD may be unable to earn

sufficient revenue to continue our business.

Despite the Company obtaining clearance or approval for its products, the commercial

success will depend in part on the level of reimbursement it receives from third parties

for the cost of its products to users.

In most markets, third parties such as health insurers, government-managed healthcare

schemes, or managed care organizations decide which treatments they will cover and how

much of the cost they will reimburse. These reimbursement systems vary widely, meaning

that approval for reimbursement must be obtained on a country-by-country basis. ONWARD’s

business could be adversely affected if hospitals or other users are not able to obtain and

maintain coverage and adequate reimbursement for procedures using our devices.

Additionally, third-party payors, especially in the US, are increasingly examining not only

product safety and effectiveness but also their cost-effectiveness when making coverage

and payment decisions. It is uncertain whether ONWARD’s current products, or any planned

or future products, will be viewed as sufficiently cost-effective to warrant coverage and

adequate reimbursement levels in any given jurisdiction.

Post-approval, the Company’s ability to achieve commercial success will depend on

securing access to hospitals, clinics, and other healthcare facilities. Failure to obtain such

access could negatively aﬀect sales and operating results.

If the Company’s investigational devices obtain regulatory clearance or approval, the

Company’s ability to achieve commercial success will depend on securing access to hospitals,

clinics, and other healthcare facilities. Failure to obtain such access could materially adversely

affect sales and operating results.

In the United States, physicians and clinicians typically require their hospitals or clinics to

enter into purchasing agreements or add the Company’s products to approved vendor lists

or formularies before they can be used. These processes often involve lengthy evaluations,

extensive negotiations, credentialing requirements, value analysis committee reviews, and

significant management time. There can be no assurance that the Company will successfully

navigate these processes or secure favorable terms.

In Europe and other international markets, certain healthcare institutions, particularly

public or government-funded entities, may require the Company to participate in formal

tender or procurement processes for purchases exceeding specified thresholds (which vary

by jurisdiction). These tenders are typically competitive, time-limited, and subject to strict

procedural and pricing requirements. The Company may not qualify to participate, submit

winning bids, or secure contracts.

Even where formal tenders are not required, private institutions may impose similar

contracting or approval hurdles. If the Company is unable to obtain access to healthcare

facilities through these processes, or if it expends substantial resources without success,

commercial adoption could be delayed or limited, resulting in lower-than-expected revenue

and harm to the Company’s business, financial condition, and results of operations.

The Company relies on a limited number of third-party suppliers and contract

manufacturers to produce and assemble its products. Loss or degradation in performance

of these suppliers and contract manufacturers could have a material adverse eﬀect on

the Company’s business, ﬁnancial condition, and results of operations.

Reliance on a

limited number of third-party suppliers and in some cases single-source suppliers, makes

Risk Management & Control

153

ONWARD

Medical Annual Report 2025

the Company vulnerable to supply shortages and problems and price ﬂuctuations, which

could further harm our business.

We rely on a limited number of third parties, some of whom are sole suppliers, to purchase

materials and components, and/or to manufacture and assemble our ARC

and ARC

platforms. Our ability to supply our products for clinical trials and, ultimately, to market

them and to develop future products, depends on the availability of sufficient quantities of

materials, components, and manufacturing services that meet regulatory requirements.

While we seek to maintain sufficient levels of inventory at all times, this may not fully protect

us from supply interruptions.

Our suppliers and contract manufacturers have generally met our demand for their products

and services on a timely basis. However, relationships with suppliers may be disrupted due to

a number of factors, such as unforeseen events that delay production or a decision by either

party to terminate the relationship.

If that occurs, we are confident that we will find alternative suppliers to meet all our needs.

However, due to the relatively low volume of orders and the bespoke nature of our requirements,

establishing new relationships would be a time-consuming and expensive process. We would

need to verify that the new supplier or third-party manufacturer maintains their facilities,

procedures, and operations in accordance with ONWARD’s quality standards and all

applicable regulatory requirements. In addition, our contract manufacturers could require

that we move production to a different facility or use alternative materials or components.

Any of these events could require us to modify the designs or specifications of our products,

and to secure new regulatory approval before implementing the change, which could result

in further delay or a refusal to grant clearance.

The Company may face challenges in manufacturing or outsourcing the production of the

ARC

system at scale, within required timelines, or at a sustainable cost.

The Company’s revenue and operating results depend, in part, on its ability to manufacture

and supply the ARC

system in sufficient quantities and quality, on a timely basis, and at a

cost that supports its commercial objectives. As the Company advances its clinical activities

and expands commercialization, it expects that manufacturing volumes will need to increase

over time.

The ARC

system incorporates components and processes that are produced both internally

and through third-party manufacturing partners. To support future demand, the Company

may need to expand manufacturing capacity, modify production processes, or increase

reliance on external manufacturing partners. Such changes may require additional investment,

operational adjustments, and the recruitment or training of personnel. In addition, changes

to manufacturing facilities or processes are subject to applicable regulatory requirements,

including notification to, and in certain cases approval by, relevant regulatory authorities.

There can be no assurance that such approvals will be obtained on a timely basis, or at all.

The Company expects that manufacturing efficiency and unit costs may improve over time

as production volumes increase and operational experience grows. However, there can be

no assurance that anticipated efficiencies will be realized or that manufacturing costs will

decline. Manufacturing yields, input costs, supplier performance, or regulatory requirements

could adversely affect production costs, which may impact margins and the Company’s ability

to achieve or maintain profitability..

The Company’s operations and reputation may be impaired if its information technology

systems fail to perform adequately or if it is the subject of a data breach or cyberaack.

Our information technology (IT) systems are essential to the successful operation of our

business. We seek to allocate and manage the necessary resources to build, maintain, and

protect our IT systems and infrastructure, as well as oversee third-party service providers.

Any failure of our IT systems to perform as anticipated could disrupt our operations and result

in transaction or reporting errors that could harm our business.

Our IT systems may be vulnerable to cyberattacks or other security incidents, service

disruptions, or other system or process failures. Such incidents could result in unauthorized

access to vendor, consumer, or other types of confidential data, as well as disruptions to

operations. While we have experienced such incidents in the past, none have been material

to date.

We rely on third-party vendors for some of our IT processes and data management needs,

which makes our operations vulnerable to a failure by any one of these vendors to perform

adequately or to maintain effective internal controls.

Risk Management & Control

155

ONWARD

Medical Annual Report 2025

To address these risks, we maintain an information security program that includes updating

technology, developing security policies and procedures, implementing and assessing the

effectiveness of controls, conducting risk assessments of third-party service providers, and

adopting business processes designed to mitigate the risk of security breaches. However,

there can be no assurance that these measures will prevent or limit the negative impact of a

future incident on our operations or business reputation.

A pandemic, epidemic, or outbreak of an infectious disease in Europe, the US, or worldwide,

including the outbreak of the novel strain of coronavirus disease (COVID-19), could

adversely aﬀect the Company’s business.

A future wide-scale outbreak of infectious disease similar to COVID-19 could negatively affect

our business in numerous ways. Our sales representatives, clinical specialists, and other

personnel may be unable to travel and access customers for training and case support. Our

production schedule may be affected if suppliers cannot manufacture or deliver parts and

components on time. Pandemic-related restrictions could lead to, inventory shortages or

obsolescence; delays in approval of our devices by regulatory authorities; delays in decisions

by insurance companies regarding coverage of our products; delays in clinical trials; delays

in growing our sales organization; adjustments or disruptions to the business of third parties

we work with, including suppliers, medical institutions, and clinical investigators; decreases

in collectability of our account receivables due to the adverse impact of the pandemic on

our clients’ cash flows; and reduced capacity of our suppliers to advance our investigational

devices through clinical trials.

While it is difficult to predict the potential economic impact and duration of a future outbreak,

the current pandemic has resulted in significant disruption of global financial markets,

reducing our ability to access capital, which could in the future negatively affect our liquidity.

In addition, a recession or market correction could have an adverse effect on our long-term

business as hospitals reduce capital spending.

To the extent that a pandemic adversely affects our business and financial results, it may also

heighten many other risks described in this section, including those relating to incurring future

operating losses, advance of the ARC

and ARC

platforms through regulatory pathways, and,

if cleared or approved, successful commercialization, supply chain, and distribution channels.

The Company’s success depends on its ability to retain its management, consultants and

other key personnel.

ONWARD depends on its senior management as well as key scientific personnel. In 2020,

Dave Marver was appointed as Chief Executive Officer. ONWARD’s Scientific Advisor, Prof.

Courtine, has been consulting since inception, in 2015, and currently serves as a consultant.

The loss of any members of senior management or key scientific personnel could harm our

business and significantly delay or prevent the achievement of research, development, or

business objectives.

Our future success also depends on our ability to attract, hire, train, and retain other highly

skilled scientific, technical, marketing, managerial, and financial personnel, as well as sales

personnel once commercialization begins. Although we will make every effort to hire and retain

qualified employees whose experience and abilities meet our needs, there is no assurance

that we will succeed. Competition for personnel in the medical technology industry is intense,

and any failure to attract and retain the necessary personnel would have a material adverse

effect on our business.

The Company may face substantial competition, which may result in others discovering,

developing, or commercializing products before or more successfully than it does.

The medical device industry is highly competitive and characterized by rapid technological

change. ONWARD faces competition from a range of organizations, including established

medical technology companies, biotechnology firms, academic institutions, government

agencies, and public and private research organizations. Many of these competitors may have

significantly greater financial, technical, and operational resources, as well as more extensive

experience in research and development, clinical trials, regulatory approval processes,

manufacturing, and commercialization.

Competitors may develop alternative therapeutic approaches or technologies that address

similar patient needs or indications, including both device-based and non-device-based

solutions. In addition, smaller or early-stage companies may become significant competitors,

particularly where they collaborate with larger or more established industry participants. If

competitors are able to develop or commercialize products more rapidly or more effectively

Risk Management & Control

157

ONWARD

Medical Annual Report 2025

than ONWARD, the Company’s competitive position and long-term prospects could be

adversely affected.

The Company also relies on intellectual property rights to protect its technologies and

competitive position. While ONWARD believes that its intellectual property provides

meaningful protection, there can be no assurance that such rights can be eﬀectively

enforced or that competitors will not challenge, invalidate, or design around them. The

outcome of any intellectual property dispute is inherently uncertain, and an adverse

outcome could negatively impact the Company’s ability to compete. Competitive actions

and market developments may adversely aﬀect the Company’s commercial strategy,

market adoption, and ﬁnancial forecasts.

ONWARD operates in markets that are influenced not only by technological innovation but

also by competitive commercial behavior and evolving market dynamics. Existing or emerging

competitors may make strategic decisions relating to pricing, reimbursement, market access,

clinical positioning, or commercialization timing that could affect ONWARD’s anticipated

sales ramp, pricing assumptions, and market share.

In addition, the publication of clinical data, whether favorable or unfavorable, by competitors

or third parties may influence physician adoption, patient demand, payer decisions, and

overall market perception of the relevant therapeutic category. Such developments could

positively or negatively affect market growth and competitive dynamics, independent of

ONWARD’s own clinical or commercial performance.

If ONWARD is unable to anticipate, respond to, or adapt its strategy to competitive actions

or changes in market conditions, its business, financial condition, results of operations, and

prospects could be adversely affected.

The Company’s business involves the use of hazardous materials such as lithium baeries

and the Company and its third-party manufacturers must comply with environmental laws

and regulations, which may be expensive and restrict how it does business.

ONWARD’s activities and those of our third-party manufacturers’ may involve the controlled

storage, use, and disposal of hazardous materials. For example, our ARC

(investigational

device) and ARC

we use lithium batteries. ONWARD and our third-party manufacturers are

subject to federal, state, local, and foreign laws and regulations governing the use, generation,

manufacture, storage, handling, and disposal of these hazardous materials. The Company

currently carries no insurance specifically covering environmental claims relating to the

use of hazardous materials. Despite the safety procedures put in place by ONWARD and its

manufacturers for handling and disposing of these materials and waste, we cannot eliminate

the risk of accidental injury or contamination from the use, storage, handling, or disposal

of hazardous materials. In the event of an accident, state or federal or other competent

authorities may curtail ONWARD’s or its manufacturers’ use of these materials and interrupt

their business operations, which could adversely affect our business.

Healthcare reform initiatives and other administrative and legislative proposals in the

United States may adversely aﬀect the Company’s business, ﬁnancial condition, results

of operations and cash ﬂows in one of its key markets.

There have been and continue to be proposals by the federal government, state governments,

regulators and third-party payors to control or manage the increased costs of healthcare and,

more generally, to reform the US healthcare system. Certain proposals could limit the prices

we are able to charge for our products, or the coverage and reimbursement available for our

products, and could limit the acceptance and availability of our product candidates. The

adoption of proposals to control costs, such as the Patient Protection and Affordable Care

Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively,

the “Affordable Care Act”), could have a material adverse effect on ONWARD’s business,

financial condition, and results of operations. There is no certainty that the Affordable Care

Act, as currently enacted or as amended in the future, will not harm our business and financial

results, and it is not possible to predict how future federal or state legislative or administrative

changes relating to healthcare reform will affect our business.

There likely will continue to be legislative and regulatory proposals at the federal and state

levels directed at containing or lowering the cost of healthcare. It is not possible to predict

the initiatives that may be adopted in the future or their full impact. The continuing efforts

of the government, insurance companies, managed care organizations, and other payors of

healthcare services to contain or reduce costs of healthcare may harm:

Risk Management & Control

159

ONWARD

Medical Annual Report 2025

•

ONWARD’s ability to set a price that it believes is fair for its products

•

ONWARD’s ability to generate revenue and achieve or maintain profitability

•

The availability of capital

Further, there has recently been heightened governmental scrutiny over the manner in which

manufacturers set prices for their marketed products, which has resulted in several US

Congressional inquiries, as well as proposed and enacted federal legislation designed to bring

transparency to product pricing and reduce the cost of products and services under government

healthcare programs. Adoption of price controls and other cost-containment measures, and

adoption of more restrictive policies in jurisdictions with existing controls and measures, may

prevent or limit the ONWARD’s ability to generate revenue and attain profitability.

In the European Union, there are currently no concrete legislative proposals in this regard.

However, the cost-effectiveness of healthcare is part of the EU agenda on effective, accessible,

and resilient health systems. This does not exclude that legislation on maximum pricing for

medical devices (e.g., in terms of their reimbursement) may be applied or developed at the

national level.

Interruption or distress in the supply chain due to geopolitical, environmental-related, and

other uncertainties beyond the Company’s control.

Geopolitical uncertainties and other business threats could damage or disrupt ONWARD’s

operations and those of our suppliers, partners, or collaborators. Interruptions to our

operations could adversely affect the anticipated timing, completion, and/or results of clinical

trials, and potential future commercialization efforts. Geopolitical tensions could lead to

sharply rising energy prices, which would have a negative impact on raw materials of our

products. Uncertainty in global markets may have a wide impact on the availability and price

of various materials and services and may also sustainably affect global financial markets.

Cost inflation may negatively impact our cash reach, while capital markets disruptions may

adversely affect our future financing possibilities. All these changes may materially affect

ONWARD’S business and negatively affect its liquidity and financial position. Environmental

factors presents risks to our operations, including the potential for additional regulatory

requirements and associated costs. The potential for more frequent and severe weather

events and water availability challenges could impact our facilities and those of our suppliers.

We cannot provide assurance that physical risks to our facilities or supply chain due to such

factors will not occur in the future. We have assessed the impact of climate-related risks on

our Financial Statements and conclude that the effects of climate-related risks do not have

a material impact on accounts and disclosures, including judgements and estimates in the

Financial Statements.

Failures by third parties may lead to higher development costs, delays in obtaining

regulatory approvals or certiﬁcations, and setbacks or obstacles in commercialization.

We rely—and may continue to rely—on third parties for critical aspects of our business,

including conducting clinical trials, data collection and analysis, marketing, manufacturing,

regulatory support, and other essential services. The success of our ARC Therapies depends

on these partnerships, and any failure by third parties to meet their contractual obligations

or regulatory requirements could lead to delays, suspensions, or even terminations of

development activities or clinical trials.

Potential risks include insufficient time or effort dedicated to our projects, failure to adhere

to clinical protocols or regulatory standards, compromised data quality or loss, financial

instability of the third party, or the need to replace a provider. While we strive to ensure strong

partnerships, we do not always have direct control over third-party performance, and our

agreements often allow them to terminate their commitments with notice. If a third party

fails to fulfill its obligations or if an agreement is terminated, finding a suitable replacement

on commercially acceptable terms may prove difficult, potentially leading to increased costs,

regulatory delays, and setbacks in the commercialization of ARC Therapies.

Additionally, many of our third-party agreements include limitations on liability, which

may restrict our ability to recover losses resulting from their performance failures. These

factors could adversely impact our development timelines, regulatory approvals, and overall

business operations.

Our results of operations could be materially harmed if we are unable to accurately

forecast customer demand for our ARC

system and manage our inventory.

Risk Management & Control

161

ONWARD

Medical Annual Report 2025

To ensure adequate inventory supply of the ARC

system in general and its components, we

must forecast inventory needs and place orders with our suppliers based on our estimates of

future demand for the ARC

system and its components. Our ability to accurately forecast

demand for our ARC

system could be negatively affected by many factors, including failure

to accurately manage our commercialization strategy, an increase or decrease in customer

demand for the ARC

system, failure to accurately predict customer acceptance of new

products, unanticipated changes in general market conditions or regulatory matters, and

weakening of economic conditions or consumer confidence in future economic conditions.

Inventory levels in excess of customer demand may result in inventory write-downs or write-

offs, which would cause our gross margin to be adversely affected and could impair the

strength of the ARC Therapy brand. Conversely, if we underestimate customer demand for

the ARC

system, our third-party contract manufacturers may not be able to deliver products

to meet our requirements, and this could result in damage to our reputation and customer

relationships. In addition, if we experience a significant increase in demand, additional supplies

of raw materials or additional manufacturing capacity may not be available when required

on terms that are acceptable to us, or at all, or suppliers or third-party manufacturers might

not be able to allocate sufficient capacity in order to meet our increased requirements, which

could have an adverse effect on our ability to meet customer demand for the ARC

system.

We intend to maintain sufficient levels of inventory in order to protect ourselves from supply

interruptions. As a result, we will be subject to the risk that a portion of our inventory may

become obsolete or expire, which could affect our earnings and cash flows due to the

resulting costs associated with the inventory impairment charges and costs required to

replace such inventory.

Non-Compliance with Manufacturing Regulations Could Disrupt Our Business and Impact

Product Availability

We rely on third-party suppliers for the manufacturing and supply of the ARC

system, and

both our own and our suppliers’ manufacturing practices are subject to extensive regulatory

oversight. In the United States, medical device manufacturing must comply with the FDA’s

Quality System Regulation (QSR), a stringent framework governing design, testing, production,

quality assurance, labeling, packaging, storage, and distribution. Additionally, we must

ensure that our suppliers maintain operations that meet both our internal quality standards

and applicable regulatory requirements. The FDA enforces compliance through periodic

inspections, which may be announced or unannounced, including audits of subcontractor

facilities. Similar regulatory requirements exist in other jurisdictions, adding further complexity

to compliance obligations.

Failure by us or our third-party suppliers to adhere to these regulations—including maintaining

an adequate, up-to-date quality management system—could result in delays in the commercial

availability of the ARC

system, interruptions to clinical trials, or setbacks in obtaining or

maintaining regulatory approvals. Non-compliance could also lead to regulatory actions,

product supply disruptions, increased costs, loss of customer trust, and exposure to potential

product liability claims, ultimately impacting sales and overall business performance.

Dependence on suppliers for ARC

system components and services poses operational

and ﬁnancial risks

The ARC

system relies on specialized components and services, many of which are sourced

from a limited number of suppliers. Any disruption in the supply of these critical elements—

whether due to supplier decisions, capacity constraints, quality issues, or regulatory

challenges—could negatively impact our business, financial condition, and operational results.

A number of ARC

system components are currently sourced from single suppliers, and

while we are working to qualify additional vendors, transitioning to new suppliers requires

extensive evaluation, testing, and regulatory approval. This process can be time-consuming

and costly, making it difficult to mitigate risks associated with supplier dependency. If a

supplier is unable or unwilling to meet our demand, investigator-initiated studies, clinical

trials for future indications, or commercialization efforts could be delayed or halted.

If we need to switch to an alternative supplier, we may face challenges such as extended

lead times, higher costs, or regulatory requirements that delay market availability. Changes

in supplier manufacturing processes or product design modifications may require new

regulatory approvals or certifications, further complicating supply continuity. Additionally,

suppliers may discontinue key components or services before the ARC

system reaches

the end of its product life cycle, potentially forcing us to secure costly last-time buys, source

alternatives at premium prices, or even halt product availability temporarily.

Risk Management & Control

163

ONWARD

Medical Annual Report 2025

Any of these supply chain disruptions could result in production delays, increased costs, and

reduced inventory availability, ultimately affecting our ability to meet market demand and

achieve profitability.

Interim, “topline,” and preliminary data from its clinical trials that the Company announces

or publishes from time to time may change as more patient data become available and

are subject to conﬁrmation, regulatory audit, and veriﬁcation procedures that could result

in material changes in the ﬁnal data.

From time to time, ONWARD may disclose interim, preliminary, or topline data from its

clinical studies and trials. Such disclosures are based on analyses of data available at the

time and are inherently subject to change as additional patient data are collected, verified,

and reviewed. Interim and preliminary results may also be subject to audit, validation, and

regulatory review procedures, which could result in differences between previously disclosed

data and final study results.

Clinical trials are complex and evolve over time. As enrollment progresses, patient follow-up

continues, or data are further analyzed, outcomes and conclusions may differ from earlier

assessments. In addition, assumptions, estimates, and methodologies applied in interim

analyses may be refined or adjusted as more comprehensive data become available. As

a result, interim or preliminary findings should not be viewed as definitive and may not be

indicative of final outcomes.

Regulatory authorities, healthcare professionals, or other stakeholders may interpret

clinical data differently or may not agree with the Company’s analyses or conclusions.

Such differences in interpretation could affect regulatory review, clinical positioning, or the

perceived value of the Company’s technologies. Moreover, selective or evolving disclosure of

clinical information, whether by the Company or third parties, may result in increased volatility

in the Company’s share price.

If interim, preliminary, or topline data differ materially from final results, or if conclusions are

revised following further analysis or regulatory review, the Company’s development programs,

commercialization prospects, business, financial condition, and results of operations could

be adversely affected.

Global: Geopolitical and macroeconomic challenges

The Company is also exposed to global economic and political risks, including U.S. – EU trade

relations, geopolitical instability, and foreign exchange fluctuations.

•

Geopolitical uncertainty: : Conflicts and diplomatic tensions may disrupt global markets

and supply chains. The Company remains flexible in sourcing and prepared to adapt

procurement strategies if needed.

•

U.S.-EU trade relations: Deteriorating diplomatic relations could lead to economic policies

that impact operations. While no immediate disruptions are expected, the Company is

evaluating diversification strategies to reduce reliance on any single market.

The Company closely monitors these evolving risks and engages with relevant stakeholders

to anticipate impacts and adjust strategies, aiming to preserve stability and support

continued growth.

Risks related to legal & government regulation

The Company must obtain FDA clearance or approval before it can sell any of its products

in the US, and CE Certiﬁcation before it can sell any of its products in the European

Union (EU). Approval of similar regulatory authorities in countries outside the US and

the EU is required before it can sell its products in countries that do not accept FDA

clearance or approval or CE Certiﬁcation. The Company may incur additional costs or

experience delays in completing, or ultimately be unable to complete, the development

and commercialization of its products if such clearance or approval is denied or delayed.

ONWARD received De Novo classification clearance from the FDA to market ARC

for use

in clinics and home in the US and CE certification in Europe. We intend to pursue additional

regulatory clearances for new indications. ARC

is a Class III device that will require PMA

approval to be marketed in the US. In Europe, under the MDR, ARC

as Class III.

The development, manufacture, and commercialization of our products are subject to

government regulation. In the US, Europe, and most other countries, ONWARD must

complete rigorous pre-clinical testing and extensive clinical trials that exhibit the safety

and effectiveness of our devices before we can apply for regulatory clearance or approval to

Risk Management & Control

165

ONWARD

Medical Annual Report 2025

market them. Regulatory bodies such as the FDA may limit approval to specific indications,

restrict the distribution of a device, or refuse to grant clearance for additional or expanded

indications, which could limit our potential revenues.

The road to regulatory approval of a new medical device is long, expensive, and uncertain.

The FDA and other regulatory authorities can delay, limit, or deny approval, grant of a De Novo

classification, or clearance of a device for many reasons, including:

•

Inability to show that the products are safe or effective for their intended uses (or, for a

510(k) device, that they are substantially equivalent to the predicate)

•

Disagreement with the design or implementation of clinical trials or the interpretation

of data

•

Serious and unexpected adverse device effects experienced by participants in

clinical trials

•

Insufficiently supportive data from pre-clinical studies and clinical trials

•

Inability to show that the clinical and other benefits of the device outweigh the risks

•

Failure of manufacturing process or facilities in meeting applicable requirements

•

Changes in policies or regulations that increase cost of compliance or render clinical

data and filings insufficient for approval or clearance

Despite the time, effort, and cost invested, our investigational devices may not pass these

stringent regulatory hurdles, which could harm our business. In addition, regulatory authorities

may place restrictions on the indicated uses of the device, limiting its market size. If the FDA

requires us to go through a longer, more rigorous process than expected for future products,

or for modifications to existing products, their introduction could be delayed or cancelled,

which could adversely affect our ability to grow our business.

In the EEA, compliance with the requirements of the Council Directive 93/42/EEC (EU Medical

Devices Directive) is a prerequisite to be able to affix the Conformité Européenne (CE) mark

to our products, without which they cannot be sold or marketed in the EEA. The EU Medical

Devices Directive is being replaced by a new Medical Devices Regulation (MDR) in the EEA

(Regulation (EU) 2017/745). The MDR, which became fully applicable on 26 May 2021, imposes

the same basic requirements as the EU Medical Devices Directive (MDD), but is generally more

stringent, especially in terms of risk classes and the oversight provided by notified bodies

that perform conformity assessments of devices.

Following its departure from the EU, on 31 January 2020, the UK continued to follow the same

regulations as the EU during a transitional period, which ended on 31 December 2020. Since

then, all medical devices must be registered with the Medicines and Healthcare products

Regulatory Agency (MHRA) before being sold on the UK market.

European CE marks continued to be recognized in UK until 30 June 2023, after which a UK

Conformity Assessed (UKCA) mark has been required for a medical device to be marketed

in the UK. Since the new MDR will not automatically apply in the UK, regulation of medical

devices in the UK may diverge from EU regulations in the future. On 28 November, 2022, the

Swiss Parliament reached a key decision by instructing the Swiss Federal Council to adapt

national laws to enable Switzerland to accept medical devices with FDA approval.

In general, if ONWARD fails to remain compliant with all applicable European laws and

regulations, we would be unable to continue to affix the CE mark to our products, which

would prevent us from selling them within the EEA, adversely affecting our business. Similarly,

our ability to market our products in the UK could be affected by any failure to maintain

compliance with UK regulations.

The clinical development process required to obtain regulatory clearances or approvals

is lengthy and expensive, with uncertain outcomes. Data generated in clinical trials is

subject to interpretation by EU regulators, the FDA, and foreign regulatory authorities.

If clinical trials of the current ARC

platform and future products (for ARC

and ARC

)

do not produce the results necessary to support regulatory clearance or approval, De

Novo classiﬁcation, or clearance in the US or with respect to the Company’s current or

future products elsewhere, it will be unable to commercialize these products. It therefore

may incur additional costs or experience delays in completing, or ultimately be unable to

complete and commercialize those products.

Risk Management & Control

167

ONWARD

Medical Annual Report 2025

Significant setbacks or failure can occur at any time during the clinical development

process, adversely affecting the cost, timing, or successful completion of trials. The following

circumstances could harm our ability to complete development or commercialize our products:

•

The FDA may reject our investigational device exemption (IDE) application and notify us

that we may not begin investigational human clinical trials

•

Regulatory authorities may disagree as to the design or implementation of our clinical trials

•

Regulators and/or institutional review boards (IRBs) may not authorize us or our research

partners to begin or continue a clinical trial at a particular site

•

We may be unable to agree on acceptable terms with prospective contract research

organizations (CRO) and clinical trial sites, the terms of which can vary significantly and

require long negotiations

•

Clinical trials may produce negative or inconclusive results, or we may not agree with

regulatory authorities on the interpretation of these results; consequently, we may

decide, or be required by regulators, to conduct additional clinical trials or abandon the

development of a product

•

The number of subjects or patients required for clinical trials may be larger than we

anticipated, enrollment in these trials may be insufficient or slow, and/or the number of

trials being conducted at any given time may be high, resulting in fewer available patients

for our clinical trial, or patients may drop out at a higher than expected rate

•

Our third-party contractors may fail to comply with regulatory requirements or meet

their contractual obligations in a timely manner, or at all

•

We may have to suspend or terminate clinical trials for various reasons, including a

finding that the subjects are being exposed to unacceptable health risks

•

We may have to amend clinical trial protocols or conduct additional studies to reflect

changes in regulatory requirements or guidance

•

We may be required to terminate clinical research for various reasons, including safety

issues or non-compliance with regulatory requirements

•

The cost of clinical trials may be greater than anticipated

•

Clinical sites may not adhere to the clinical protocol or may drop out of a trial

•

We may be unable to recruit a sufficient number of trial sites or trial subjects

•

Regulators, IRBs, or other reviewing bodies may fail to approve or subsequently find

fault with our manufacturing processes; the supply of devices or other materials

necessary to conduct clinical trials may be insufficient, inadequate, or not available at

an acceptable cost

•

Approval policies or regulations may change in a manner that renders our clinical data

insufficient for approval

•

Our current or future products may have undesirable side effects or other unexpected

characteristics

We depend on CROs to conduct clinical trials in a timely manner and in compliance with good

clinical practice (GCP) requirements. If a CRO fails to comply fully with GCP standards or

experiences delays in conducting the trial, this could result in increased costs and/or program

delays. In addition, conducting clinical trials in countries outside the US and Europe may entail

additional delays, shipment costs, or regulatory requirements, as well as risks associated with

clinical investigators who are unknown to the FDA, or with different standards of diagnosis,

screening, and medical care. Any of these occurrences could adversely affect our business,

financial condition, and results of operations.

We may from time to time publicly announce the date at which we expect to reach various

clinical, regulatory, or product development milestones. These could include the submission

of an IDE application to the FDA to begin a clinical trial, the enrollment of patients in a trial,

or the release of data from clinical trials. However, the actual timing of these milestones may

vary dramatically compared to our estimates, in some cases for reasons beyond our control,

potentially delaying the commercialization of our products or causing our share price to decline.

Failure to comply with post-marketing regulatory requirements could subject the Company

to enforcement actions, including substantial penalties, and might require the Company

to recall or withdraw a product from the market.

Risk Management & Control

169

ONWARD

Medical Annual Report 2025

If we receive regulatory clearance or approval for our investigational devices (like we have

for ARC

), we will be subject to ongoing and pervasive regulatory requirements governing,

among other things, their manufacture, marketing, labeling, packaging, advertising, medical

device reporting, sale, promotion, registration, storage, distribution, and listing. For example,

ONWARD must submit periodic reports to the FDA as a condition of PMA approval. These

reports include safety and effectiveness information about the device after its approval.

Failure to submit such reports or to do so in a timely manner could result in enforcement

action by the FDA. Following its review of the periodic reports, the FDA might ask for additional

information or initiate further investigation.

In addition, the PMA approval for ARC

Therapy may be subject to several conditions of

approval, including a post-market extended follow-up of the premarket study cohort. Any

failure to comply with the conditions of approval could result in the withdrawal of PMA

approval and the inability to continue to market the device. Adverse outcomes in these studies

could also be grounds for withdrawal of approval of the PMA.

The regulations to which ONWARD is subject are complex and have become more stringent over

time. Regulatory changes could result in restrictions on our ability to continue or expand our

operations, higher than anticipated costs, or lower than anticipated sales. Even after the proper

regulatory authorization to market a device has been obtained, we have ongoing responsibilities

under FDA and EU regulations and applicable laws and regulations of other countries.

Any failure to comply with applicable regulatory requirements could result in enforcement

action by the FDA, state, EU or national regulatory authorities. Sanctions could include

warning letters, fines, injunctions, consent decrees or civil penalties; recalls, termination

of distribution, administrative detention, or seizure of products; suspension of one or more

clinical studies; customer notifications, repair, replacement or refunds; restriction, partial

suspension or total shutdown of production; delays in or refusal to grant requests for future

regulatory approvals of new products, uses, or modifications to existing products; withdrawals

or suspensions of current regulatory approvals; prohibitions on sales, imports, or exports of

our products; FDA refusal to issue certificates to foreign governments needed to export our

products for sale in other countries; and criminal prosecution.

Any of these sanctions could result in higher than anticipated costs or lower than anticipated

sales and have a material adverse effect on our reputation, business, financial condition, and

operating results.

Even if, and aﬅer being, cleared or approved by regulatory authorities, the Company’s

products may cause or contribute to adverse medical events or be subject to failures

or malfunctions that the Company is required to report to the FDA. If it fails to do so,

the Company would be subject to sanctions that could harm its reputation, business,

ﬁnancial condition, and results of operations. The discovery of serious safety issues with

its products, or a recall of its products, either voluntarily or at the direction of the FDA

or another governmental authority, could have a negative impact on the Company. In

the course of conducting our business, the Company must adequately address quality

issues that may arise with the ARC

and ARC

systems, including defects in third-

party components included in our

products. Additionally, even if free of quality issues,

our

products may not meet the expectations of physicians or patients with respect to

achieving desired results.

The internal procedures designed to minimize risks that may arise from quality issues may

not sufficiently eliminate or mitigate occurrences of these issues and associated liabilities.

Moreover, even in the absence of quality issues, we may be subject to claims and liability if

our products’ performance does not meet physicians’ or patients’ expectations.

In the event that we receive clearance or approval by regulatory authorities, we will be subject

to the FDA’s medical device reporting regulations and similar foreign regulations. This will

require us to report to the FDA when we become aware of information that reasonably

suggests that our products may have caused or contributed to a death or serious injury or

malfunctioned in a way that, if it were to recur, could cause or contribute to a death or serious

injury. The timing of this obligation to report is triggered by the date we become aware of

the adverse event, as well as the nature of the event. We may inadvertently fail to report

adverse events within the prescribed timeframe. We may also fail to recognize that we have

become aware of a reportable adverse event, especially if it is not reported to us as such,

or if the adverse event is unexpected or removed in time from the use of our products. If we

fail to comply with our reporting obligations, the FDA could take action, including warning

Risk Management & Control

171

ONWARD

Medical Annual Report 2025

letters, untitled letters, administrative actions, criminal prosecution, civil monetary penalties,

revocation of device approvals, seizure of our products, or delay in clearance or approval of

modifications to our products.

The FDA and foreign regulatory authorities have the power to require the recall of

commercialized products in the event of material deficiencies or defects in design or

manufacture of a product, or in the event that a product poses an unacceptable risk to health.

The FDA’s authority to require a recall of our products must be based on a finding that there

is reasonable probability that they may cause serious injury or death. We may also choose

to voluntarily recall products if any material deficiency is found. A government-mandated

or voluntary recall could occur as a result of an unacceptable risk to health, component

failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging

defects, or other deficiencies or failures to comply with applicable regulations. Depending

on the corrective action that we take to redress deficiencies or defects that may occur in

the future, the FDA may require, or we may decide, that we need to obtain new approvals for

our products before marketing or distributing the corrected device. Seeking such approvals

may delay our ability to replace the recalled devices in a timely manner. Moreover, if we

fail to adequately address problems associated with our products, we may face additional

regulatory enforcement action.

Companies are required to maintain certain records of recalls and corrections, even if they

are not reportable to the FDA. In the future, ONWARD may initiate voluntary withdrawals or

corrections to our products that we may determine do not require notification of the FDA.

If the FDA disagrees with our determinations, it could require us to report those actions as

recalls and subject us to enforcement action. Such a recall announcement could harm our

reputation with customers, potentially lead to product liability claims, and negatively affect

sales. Any lawsuit or corrective action, whether voluntary or involuntary, would require the

dedication of considerable time and capital, possibly impacting our financial results.

Additionally, the identification of undesirable side effects or other previously unknown

problems caused by our products could lead to a number of negative consequences. Among

others, regulatory authorities might withdraw approvals; impose product recalls; require us to

add warnings, contraindications, or narrower indications in the product labeling, or to issue

of field alerts to physicians and pharmacies; require us to create a guide outlining the risks

of such side effects for distribution to patients; impose limitations on how we promote our

products; require us to change the way the product is administered or modify the product;

and/or require additional clinical trials or costly post-marketing testing and surveillance to

monitor the safety or efficacy of the product. Any of these requirements could prevent us from

achieving or maintaining market acceptance of our products, substantially increase the costs

of commercializing our products, or impacts our sales. The demand for our products could

also be negatively impacted by any adverse effects of a competitor’s product or treatment.

If the Company or its suppliers fail to comply with FDA regulatory requirements, or if

it experiences unanticipated problems with any cleared or approved products, these

products could be subject to restrictions or withdrawal from the market.

Any product for which we obtain regulatory clearance or approval, as well as the manufacturing

processes, reporting requirements, post-approval clinical data, and promotional activities

for such a product, will be subject to continued regulatory review and oversight by the

FDA. In particular, ONWARD and its third-party suppliers will be required to comply with

the FDA’s Quality System Regulations (QSR). These FDA regulations cover the methods

and documentation of the design, testing, production, control, quality assurance, labeling,

packaging, sterilization, storage, and shipping of products. Compliance with applicable

regulatory requirements is subject to continual review and is monitored rigorously through

periodic inspections by the FDA. If we, or our manufacturers, fail to adhere to QSR requirements,

this could delay production of our products and lead to fines, difficulties in obtaining regulatory

clearances and approvals, recalls, enforcement actions, including injunctive relief or consent

decrees, or other consequences, which could, in turn, have a material adverse effect on our

financial condition and results of operations.

In addition, ONWARD and its suppliers are required to comply with Good Manufacturing

Practices for the manufacture of our products, and other regulations which cover the methods

and documentation of the design, testing, production, control, quality assurance, labeling,

packaging, storage, and shipping of any product for which we obtain clearance or approval.

The FDA audits compliance with the QSR and other similar regulatory requirements through

periodic announced and unannounced inspections of manufacturing and other facilities.

Risk Management & Control

173

ONWARD

Medical Annual Report 2025

If ONWARD or one of its suppliers fail to comply with applicable statutes and regulations

administered by the FDA, or the fail to timely and adequately respond to any adverse

inspectional observations or product safety issues, this could result in any of the following

enforcement actions:

•

Untitled letters, warning letters, fines, injunctions, consent decrees, and civil penalties

•

Unanticipated expenditures to address or defend such actions

•

Customer notifications or repair, replacement, refunds, recall, detention, or seizure

of our products

•

Operating restrictions or partial suspension or total shutdown of production

•

Refusing or delaying our requests for premarket approval of new products or

modified products

•

Withdrawing PMAs that have already been granted

•

Refusal to grant export approval for our products

•

Criminal prosecution

Any of these sanctions could have a material adverse effect on our reputation, business,

results of operations, and financial condition.

EU MDR Certification and Notified Body Capacity Risk

Seeking, obtaining, and maintaining certification in the European Union under the Medical

Device Regulation (EU MDR) is a complex and evolving process that may be subject to

uncertainty in timing and outcome. Medical devices placed on the EU market are required

to comply with the MDR, including the transition and recertification of devices previously

certified under earlier EU directives. In addition, certain modifications to existing CE-marked

devices may require review and certification under the MDR prior to implementation.

Conformity assessments under the MDR must be performed by Notified Bodies designated by

EU Member States. The MDR introduced more stringent requirements for the designation and

oversight of Notified Bodies, including enhanced technical expertise and quality management

standards. While the number of designated Notified Bodies has increased over time, capacity

constraints, prioritization decisions, and review backlogs may still occur and could result in

delays to certification or recertification activities.

The Company also relies on third parties within the EU supply and distribution chain that are

required to comply with MDR obligations. If any such third party fails to meet applicable MDR

requirements on a timely basis, the marketing or sale of the Company’s products in the EU

could be delayed, restricted, or suspended.

Any delay or failure to obtain, maintain, or renew required EU MDR certifications could adversely

affect the Company’s ability to commercialize products in EU Member States, implement

product changes, or continue selling certified products, and could have a material adverse

effect on the Company’s business, financial condition, results of operations, and prospects.

Product Liability and Insurance Risk

ONWARD’s business involves the development, manufacture, and commercialization of

medical devices, which exposes the Company to the risk of product liability claims that are

inherent in the medical device industry. The ARC-EX system is designed to interact with

the human body and, as with any complex medical device, there is a risk that product use,

component failure, or associated medical procedures could result in adverse events.

Product liability claims may arise in connection with clinical use, commercial use, or surgical

or therapeutic procedures involving the Company’s products, including in key markets such as

the United States and Europe. Such claims may be brought by patients, healthcare providers,

distributors, or other parties and may occur regardless of whether the products are approved

or cleared by regulatory authorities or manufactured in compliance with applicable regulatory

standards. In addition, events caused by third parties within the Company’s supply chain,

including component suppliers or manufacturing partners, could also give rise to claims

against the Company.

Product liability claims, whether or not ultimately successful, could result in significant

costs, including legal expenses, potential damages, product recalls or withdrawals, delays

or restrictions on commercialization, reputational harm, and diversion of management’s

Risk Management & Control

175

ONWARD

Medical Annual Report 2025

attention. Any of these outcomes could have a material adverse effect on the Company’s

business, financial condition, results of operations, and prospects.

The Company maintains product liability and clinical trial liability insurance at levels it

believes are appropriate for its stage of development and commercialization. However,

such insurance is subject to deductibles, exclusions, and coverage limitations, and there

can be no assurance that adequate coverage will remain available on acceptable terms, or

at all. Insurance coverage may be insufficient to cover all potential liabilities, particularly in

jurisdictions such as the United States, where product liability claims may involve substantial

damages. As of the date of this Annual Report, no product liability claims have been brought

against the Company.

U.S.: Regulatory, tariﬀ, and economic uncertainty

The Company faces risks from evolving U.S. policies, including potential tariffs on European

goods, reductions in federal healthcare and research funding, and economic uncertainties

affecting market conditions.

•

Tariff Risks: The Company believes that certain of its products may qualify for an

exemption from U.S. import duties under the Nairobi Protocol and continues to seek

clarification from U.S. Customs and Border Protection regarding eligibility. However,

there can be no assurance that such an exemption will be granted or maintained.

Currently, products imported from the Netherlands are subject to a 15% tariff. Products

imported into the United States from Europe are currently subject to U.S. import tariffs,

the level of which may change over time. Depending on the applicable tariff rate,

including the possibility of increases, such duties could have a material impact on the

Company’s cost structure, pricing, margins, and competitiveness in the U.S. market.

While the Company continues to assess mitigation options, including pricing, supply

chain adjustments, and potential exemptions, there can be no assurance that such

measures would fully offset the impact of tariffs.

•

Federal spending cuts: Potential reductions in NIH and DoD funding could affect grants

and clinical research. The Company is diversifying funding sources, including European

grants, to mitigate this risk.

•

U.S. regulatory environment: Recent developments, including policy discussions under

Project 2025, may significantly alter the structure and functioning of U.S. federal

agencies such as the FDA. This raises uncertainty around regulatory timelines, product

clearances, and reimbursement. Potential federal budget constraints may also impact

agency responsiveness, increasing risk for companies in the medtech sector. The

Company continues proactive engagement with regulatory authorities to manage

submission timelines effectively.

While these factors introduce uncertainty, the Company is actively mitigating risks through

strategic planning, advocacy efforts, and financial diversification.

Risks related to the company’s intellectual property (IP)

Patent terms may be inadequate to protect the Company’s competitive position on its

future products for an adequate amount of time.

In both the US and Europe, a patent’s lifespan is generally 20 years from its earliest filing date.

Various extensions may be available, but the life of a patent, and the protection it affords, is

limited. Even if patents covering the Company’s future products are obtained, once the patent

has expired, it may be open to competition.

ONWARD’s current patent portfolio will begin to naturally expire in 2031. However, given

the amount of time required for the development, testing, and regulatory review of new

products, certain patents protecting our future products may expire before or shortly after

commercialization begins. As a result, our patent portfolio may not provide the Company

with sufficient rights to exclude others from commercializing similar or identical products

for a sufficient amount of time.

The Company licenses certain technology underlying the development of its investigational

devices and the loss of the license would result in a material adverse eﬀect on its business,

ﬁnancial position, and operating results and cause the market value of its Ordinary Shares

to decline.

The Company licenses technology from EPFL, UCLA, California Institute for Technology

(“Caltech”), University of Louisville, University of Minnesota, University of Calgary and

University of British Columbia that is integrated into its company portfolio under five licenses,

Risk Management & Control

177

ONWARD

Medical Annual Report 2025

each exclusive in the Company’s Field of Uses. Under the different license agreements, the

Company has agreed to milestone payments and/or to meet certain reporting obligations.

In the event that the Company were to breach any of the obligations under the agreement

and fail to cure timely, EPFL, UCLA, Caltech, would have the right to terminate the agreement

upon notice. In addition, EPFL, UCLA and Caltech have the right to terminate its license upon

the bankruptcy or receivership of the Company. If the Company is unable to continue to use

or license this technology on reasonable terms, or if this technology fails to operate properly,

it may not be able to secure alternatives in a timely manner and its ability to develop its

products could be harmed.

The Company may in the future become, involved in lawsuits to defend itself against

intellectual property disputes, which could be expensive and time consuming, and

ultimately unsuccessful, and could result in the diversion of signiﬁcant resources, and

hinder its ability to commercialize its existing or future products.

ONWARD operates in a technology- and patent-intensive industry and relies on intellectual

property rights to protect its technologies and commercial activities. Despite the Company’s

efforts to build and maintain a robust intellectual property portfolio and to conduct freedom-

to-operate analyses, there can be no assurance that third parties will not assert claims

alleging infringement, misappropriation, or invalidity of intellectual property rights.

The medical device sector is characterized by a high volume of patents, rapid technological

development, and increasing competition. As a result, intellectual property disputes, whether

or not they have merit, may arise from time to time. Such disputes may involve allegations

that the Company’s products, technologies, or methods infringe third-party patents or other

proprietary rights, or that intellectual property developed by the Company is subject to

inventorship, ownership, or licensing challenges. Patent applications filed by third parties may

also result in issued patents that could potentially be asserted against the Company, including

patents of which the Company may not be aware at the time of product development.

Defending against intellectual property claims can be costly, time-consuming, and

unpredictable, and may divert management attention and financial resources away from

core business activities. In the event of an adverse outcome, the Company could be required

to obtain licenses on unfavorable terms, pay damages or royalties, redesign products or

processes, or, in some circumstances, cease the manufacture, sale, or use of certain products.

Any of these outcomes could delay commercialization efforts, increase costs, or adversely affect

the Company’s competitive position, financial condition, results of operations, and prospects.

In addition, the Company may be required under certain circumstances to indemnify

customers or distribution partners against intellectual property claims relating to the use or

sale of its products. Such claims, even if ultimately unsuccessful, could result in additional

legal costs, operational disruption, and reputational harm.

Intellectual property litigation and related proceedings, whether initiated by or against the

Company, are inherently uncertain and may also give rise to public disclosures that could

contribute to volatility in the Company’s share price. There can be no assurance that the

Company will be able to successfully defend its intellectual property position in all cases or

that such disputes, if they arise, will not have a material adverse effect on the Company.

Risks Related to the Company’s financial position, need for additional capital & taxation

The Company has incurred signiﬁcant operating losses since inception, expects to incur

operating losses in future, and it may not be able to achieve or sustain proﬁtability.

ONWARD is a medical technology company with limited commercial operating history. To

date, we have substantially invested all of our efforts in the research and development of,

and in seeking regulatory clearance or approval for, our ARC technology platforms. We are

not profitable, have incurred losses each year since beginning operations in 2014, and have

limited commercial operating history upon which to evaluate our business and prospects.

Any predictions of future success, performance, or viability may not be as accurate as they

could be if the Company had a longer operating history or commercial revenues.

Despite receiving FDA clearance to commercialise its first product (ARC

for clinical use),

deriving sufficient revenues to support operations are not imminent, as our activities continue

to consist of developing our technology, conducting pre-clinical studies and clinical trials.

As of 31 December 2025, the loss for the period amounted to € 43.1M. These losses have

primarily resulted from continued investment in product development activities, costs

associated with regulatory approvals, including FDA clearance for home use and CE marking

in Europe, preparations for and scaling of manufacturing activities following regulatory

approvals, expenses related to the preparation of the ARC

blood pressure clinical trial, and

Risk Management & Control

179

ONWARD

Medical Annual Report 2025

ongoing general and administrative costs required to support the Company’s operations

and commercialization efforts. The current or future clinical trials of any current or future

investigational devices are, and the manufacturing and marketing of any such investigational

devices will be, subject to extensive and rigorous review and regulation by the FDA and other

government authorities in the US and in other countries where the Company intends to test

and, if cleared or approved, market such investigational devices. We expect our operating

expenses to continue to increase as we;

Continue research and development activities for our ARC

, ARC

and ARC

BCI

technology

platforms and related technologies

Seek FDA regulatory clearances and approvals for the ARC

(new indications), ARC

and

ARC

BCI

platforms or other future investigational devices in the US, regulatory approvals in

Europe, and potentially other regulatory approvals in other jurisdictions

Build our commercial infrastructure

As a result, ONWARD expects to continue to incur operating losses for the foreseeable

future. The expected future operating losses, combined with prior operating losses, may

adversely affect the market price of our Ordinary Shares and our ability to raise capital

and continue operations.

We expect sales of our ARC

and ARC

platforms to account for the majority of our future

revenue. While ARC

has received regulatory clearance in the US and Europe, ,if ARC

sales

do not generate sufficient revenue, or if the ARC

platform does not obtain clearance or

approval, the Company may face challenges in achieving profitability.

Even if we do achieve profitability, we may not be able to sustain or increase profitability

in subsequent periods or on an ongoing basis. In this case, it will be more difficult for us to

finance our business and realize our strategic objectives, which would have a material and

adverse effect on our business, financial condition, and results of operations and would cause

the market price of our Ordinary Shares to decline.

The Company will require additional capital to ﬁnance its planned operations, which may

not be available to it on acceptable terms or at all. Raising additional capital may cause

dilution to our existing shareholders.

As of 31 December 2025, ONWARD had net cash of € 68 million. Based on cash flow forecasts

for 2026, this will be sufficient to meet our capital requirements and fund our operations into

2027. We have based these estimates on assumptions that may prove to be incorrect and could

spend our available financial resources much faster than currently expected.

As ONWARD advances the commercialization of ARC

in the United States and Europe, the

Company expects its operating expenses to increase. These increases will primarily relate to the

expansion of commercial, manufacturing, and operational capabilities, including investments in

sales, service, supply chain, and supporting infrastructure. In addition, expenses are expected to

increase in connection with the execution of pivotal clinical activities, including the Empower BP

clinical trial evaluating ARC

for blood pressure stabilization. Additional expenditures will also

reflect the ongoing costs of operating as a public company and supporting broader corporate

functions. While management seeks to carefully manage costs, other unanticipated expenses

may arise as the business continues to scale.

ONWARD’s present and future funding requirements will depend on a number of factors, including:

•

continuing research and development activities, including ongoing product enhancements

and platform development;

•

conducting ongoing and planned clinical studies, including the execution of pivotal

clinical trials for additional indications;

•

costs associated with commercialization activities, including manufacturing, supply

chain management, sales, service, and market access efforts in the United States,

Europe, and other jurisdictions;

•

the Company’s ability to attract, retain, and appropriately compensate highly qualified

personnel across clinical, commercial, technical, and corporate functions;

•

the ability to achieve market adoption, reimbursement coverage, and sustained demand

for the Company’s products;

•

costs related to maintaining, expanding, and defending the Company’s intellectual

property portfolio, including licensing activities and potential enforcement actions;

Risk Management & Control

181

ONWARD

Medical Annual Report 2025

•

the emergence of competing technologies or adverse market developments, and the

need to further enhance existing products or develop new solutions;

•

the establishment and maintenance of strategic partnerships or licensing arrangements

and the financial terms of such agreements; and

•

continued investment in internal systems, processes, and controls to support growth,

regulatory compliance, and public company reporting requirements.

ONWARD will likely need to raise additional capital. If we do so through public or private equity

offerings, the ownership interest of existing shareholders will be diluted, and the terms of these

securities may include liquidation or other preferences that adversely affect these shareholders’

rights. If the Company raises additional capital through debt financing, we may have to provide

new liens on our assets and be subject to covenants limiting or restricting our ability to take

specific actions, such as incurring additional debt or liens, making capital expenditures,

or declaring dividends. If we raise additional capital through marketing and distribution

arrangements or other collaborations, strategic alliances, or licensing arrangements with third

parties, we may have to relinquish certain valuable rights to our ARC

and ARC

platforms,

technologies, future revenue streams, or research programs, or grant licenses on terms that may

not be favorable to us. In addition, the exercise by our employees of stock options under stock

option plans within the scope of existing and/or future management or employee participation

would lead to a dilution of the shareholders.

If we are unable to obtain adequate financing when needed, and on terms that are acceptable

to us, we may have to delay, reduce the scope of, or suspend the implementation of our sales

and marketing plan and our ongoing research and development efforts, which would have a

material adverse effect on our business, financial condition, and results of operations.

Part of the Company’s assets, including intellectual property is pledged to Runway Growth

Capital LLC, and the enforcement of such pledge could substantially harm the future

development and operations of the Company.

The Company has secured a € 52.5 million loan from U.S.-based lender Runway Growth

Capital LLC (Runway). The facility is divided into five individual credit tranches. The first initial

credit tranche of €16.0 million was available upon signing of the Loan Agreement and drawn

down immediately. Three subsequent credit tranches of €14.0 million, up to €5.0 million and

up to €7.5 million will be available to be drawn by the Company until July 31, 2026, subject to

the Company’s achievement of certain milestones and conditions under the Loan Agreement.

The fifth credit tranche of up to €10.0 million is uncommitted and available in the first quarter

of 2027 upon the sole discretion of the Lender. The loan bears interest at a rate equal to Term

Secured Overnight Financing Rate (SOFR) for a three month interest period (December 2025:

4.25% and subject to a 4.25% floor), plus a margin of 6.50%. The loan documents provide for a

number of affirmative and negative covenants by the Company, including financial covenants

relating to revenue, earnings before interest taxes, depreciation and amortization (EBITDA)

and minimum liquidity targets. The loans advanced under the Loan Agreement are secured

by a security interest in substantially all of the assets of ONWARD.

Should the Company default on the loan covenants, Runway could enforce its pledge on

these assets, which could substantially harm the future development and operations of

the Company.

The Company’s operating results may vary signiﬁcantly from period to period, which may

negatively impact the price of its Ordinary Shares in the future.

ONWARD’s financial and operating results may fluctuate from period to period due to,

among others:

•

The cost of obtaining and maintaining FDA and other regulatory clearances or approvals

for our ARC

and ARC

platforms, as well as any other future indication we may seek to

develop our investigational devices to address

•

Potential revenue generated by sales of our ARC

and ARC

platforms for cleared or

approved indications, if any

•

Expenses incurred in manufacturing and selling our ARC

and ARC

platforms, after

cleared or approved

•

Costs associated with scaling up and expanding our manufacturing capacity

•

Costs associated with building and expanding our sales and marketing efforts in the US,

Europe, and internationally

Risk Management & Control

183

ONWARD

Medical Annual Report 2025

•

Costs associated with conducting research and development efforts for future

improvements to, or versions of, our ARC

and ARCIM platforms

•

Cost of complying with regulatory requirements

•

Costs associated with capital expenditures

•

Costs associated with any future litigation

•

Costs and timing of preparing, filing, and prosecuting patent applications, maintaining

and enforcing our IP rights, and defending any IP-related claims

•

The severity, duration, and impact of a pandemic similar to COVID-19, which may

adversely impact our business and planned development and future commercialization

of our ARC

and ARC

platforms

Due to these and other factors, it is likely that ONWARD will experience fluctuating revenues,

operating results, and cash flows. In that case, period-to-period comparisons of financial

results may not necessarily be meaningful, and results of operations in prior periods should

not be relied upon as an indication of future performance, as this will not meet investor

expectations or those of public market analysts. Unanticipated or new information may

cause investors and analysts to revalue our business, which could cause a decline in the

price of our Ordinary Shares.

The Company’s ability to use its net operating losses and research and development credit

carryforwards to oﬀset future taxable income may be subject to certain US federal income

tax and Dutch tax limitations.

In general, under Sections 382 and 383 of the US Internal Revenue Code of 1986, as amended,

a corporation that undergoes an “ownership change” — generally defined as a greater

than 50% change by value in its equity ownership over a three-year period — is subject to

limitations on its ability to use its pre-change net operating losses (NOL) and its research and

development credit carryforwards to offset future taxable income. The Company’s existing

NOLs and research and development credit carryforwards may be subject to limitations

arising from previous ownership changes, and if it undergoes an ownership change, our ability

to use NOLs and research and development credit carryforwards could be further limited by

Sections 382 and 383 of the Internal Revenue Code.

In addition, our ability to deduct net interest expense may be limited if the Company has

insufficient taxable income for the year during which the interest is incurred, and any

carryovers of such disallowed interest would be subject to the limitation rules similar to those

applicable to NOLs and other attributes. Future changes in share ownership, some of which

might be beyond our control, could result in an ownership change under Section 382 of the

Internal Revenue Code.

For these reasons, in the event that ONWARD experiences a change of control, we may not be

able to use a material portion of the NOLs, research and development credit carryforwards,

or disallowed interest expense carryovers, even if we attain profitability.

The Company’s results may be impacted by changes in foreign currency exchange rates.

Since the clearance of ARC

by the FDA for use in clinics and home, we commenced

commercial operations, we will enter into a number of transactions denominated in USD

(initially) but also expanding to various currencies, which can expose the Company to changes

in currency exchange rates. We do not currently engage in any hedging transactions. If we are

unable to address these risks and challenges effectively, our international operations may

not be successful and our business could be harmed.

If the Company or a Group Company breaches an obligation under the Group’s existing

loan agreement, the Group may be required to repay the loan before it would ordinarily

become due and the administrative and collateral agent under the loan agreement may

dispose of the signiﬁcant collateral the Group furnished to secure the loan.

The Group is subject to financial and non-financial covenants under its existing loan

agreement. A breach of any covenant or obligation could result in the lender exercising its

rights under the loan agreement, including demanding immediate repayment of outstanding

amounts before their scheduled maturity. In such a scenario, the Group may be required

to secure alternative financing under potentially unfavorable terms or may face liquidity

constraints that could impact its ability to fund operations and strategic initiatives.

Risk Management & Control

185

ONWARD

Medical Annual Report 2025

Furthermore, the loan agreement is secured by significant collateral, and in the event of

default, the administrative and collateral agent may exercise its rights to enforce security

interests, which could materially impact the Group’s financial position and operations. The

Group actively monitors compliance with its loan covenants and engages with its lenders to

mitigate the risk of default. However, there can be no assurance that a breach will not occur in

the future, particularly in the context of evolving business conditions, financial performance,

or changes in the regulatory environment.

Additionally, the Group recently launched ARC

, a novel product with no directly comparable

market data to substantiate sales projections. While Management has developed revenue

forecasts based on market research and initial customer interest, the absence of historical

sales data introduces a significant degree of uncertainty regarding revenue generation. This

uncertainty in cash flow forecasts is further compounded by the Group’s financing obligations,

relating to maintaining compliance with loan covenants.

While the Group has remained in compliance with its loan covenants to date, future financial

performance may impact continued compliance. Although the Group believes it has the

necessary resources to fund operations for the foreseeable future, the heightened uncertainty

surrounding revenue projections and financing obligations indicates the existence of material

uncertainties, which may also cast significant doubt on the Group’s ability to continue as a

going concern. The financial statements have been prepared on a going concern basis, as

outlined in the Accounting Policies section of the consolidated financial statements.

The Company does not currently have suﬃcient working capital to fund its operations for

at least the next 12 months following the date of this report.

The Company does not currently have sufficient working capital to fund its operations for

at least the twelve months following the date of this Annual Report. While ONWARD has

successfully raised capital in recent periods and continues to actively manage its liquidity

position, its ability to continue executing its strategy and meet operational, development, and

commercialization objectives remains dependent on securing additional funding.

Future funding requirements may arise due to operating losses, the timing and scale of research

and development activities, clinical programs, regulatory processes, commercialization

efforts, or other strategic initiatives. There can be no assurance that additional financing will

be available when required, or that it will be available on acceptable terms. Such financing

may include equity, debt, or non-dilutive funding sources.

If the Company is unable to obtain additional funding in a timely manner or in sufficient

amounts, it may be required to delay, scale back, or modify planned activities, which could

have a material adverse effect on its business, financial condition, and prospects.

Risk Management & Control

Investor

Relations

189

ONWARD

Medical Annual Report 2025

We engage in and maintain open dialogue with investors and analysts through several

communication channels, including the Annual General Meeting, roadshows, investor

conferences, presentations, and webcasts.

Up-to-date financial information about ONWARD is published on our Investor Relations

website

(ir.onwd.com)

. Investors and analysts are encouraged to visit the website regularly

for detailed coverage of the share price, shareholder meetings, half-year and annual results,

press releases, presentations, webcasts, and investor relations events. Closed periods are

announced in line with publication dates as required.

Investor Relations

Dividend Policy

ONWARD has not declared or paid dividends on its shares in the past and does not currently

have the intention to pay dividends. Any declaration of dividends will be based on the

Company’s earnings, financial condition, capital requirements, and other factors considered

important by the Board.

Dutch law and ONWARD’s Articles of Association do not require the Company to declare

dividends. Currently, the Board expects to retain all earnings, if any, generated by ONWARD’s

operations for the development and growth of the business and does not anticipate paying

dividends to shareholders in the near future.

Capital Structure & Voting Rights

ONWARD’s authorized share capital

(maatschappelijk kapitaal)

amounts to € 18,000,000

divided into 75,000,000 Ordinary Shares and 75,000,000 Preferred Shares with a nominal

value of € 0.12 each. All of the issued Ordinary Shares are fully paid-up and represent capital

in the Company. Each shareholder of the Company is entitled to one vote per share. No

shareholders have any voting rights different from any other shareholder. At 31 December 2025,

56,008,257 (31 December 2024:44,628,834) Ordinary Shares represented all issued capital.

The Board is authorized by a resolution of the General Meeting to issue shares, or grant rights

to subscribe for shares, limited to 10% of the issued share capital. A separate resolution of

the General Meeting is not required for the issuance of shares under this authorization.

The Board remains of the view that it is in the company’s best interests to be able to react

promptly when business opportunities arise that require the issuance of Ordinary Shares.

For this purpose the Board was also authorized to issue Ordinary Shares, or grant rights to

191

ONWARD

Medical Annual Report 2025

subscribe for shares, for an additional 50% of the Company’s issued share capital in connection

with one or more potential capital raises or for other strategic purposes. The authorization

was partially utilized for the capital transaction in October 2025. A separate resolution of the

General Meeting is not required for the issuance of shares under this authorization.

ONWARD is not aware of any agreements that may result in a limitation of the transferability

of voting rights on shares in its capital.

Shareholder Structure

Pursuant to the Dutch Financial Supervision Act (Wet op het financieel toezicht), substantial

holdings in the Company must be disclosed to the Netherlands Authority for Financial Markets

(Stichting Autoriteit Financiële Markten, AFM). According to the register kept by the AFM,

the following shareholders disclosed that they have a direct or indirect (potential) interest of

between 3% and 25% in the Company’s total issued share capital as of 31 December 2025:

•

Ottobock SE & Co. KGaA (12.00%)

•

LSP Advisory B.V. (6.70%)

•

INKEF Capital B.V. (6.52%)

•

Gimv (Private Equity) (4.31%)

•

Invus Public Equities Advisors LLC (3.21%)

•

AXA Investment Managers UK Ltd. (3.13%)

Listing

Shares of ONWARD Medical N.V. trade on Euronext in Brussels (primary listing), Euronext

Amsterdam and Euronext Paris under the symbol “ONWD.”

Share Price

Analyst Coverage

ONWARD was covered by five brokers at the end of 2025.

Broker

Analysts

Stifel

Ed Hall

KBC Securities

Jacob Mekhael

Degroof Petercam

David Seynnaeve, PhD

Kepler Cheuvreux

Christophe Dombu

Portzamparc – BNP Paribas Group

Clément Bassat

Investor Relations

Report of the

Non-Executive

Directors

195

ONWARD

Medical Annual Report 2025

Below is the report of the Non-Executive Directors of the Company for the financial year 2025,

as referred to in best practice provision 5.1.5 of the Corporate Governance Code (CGC).

Supervision by the Non-Executive Directors

The Board is responsible for ensuring that the Executive Director and Management Team

align their actions with the company’s strategic priorities and core values. The Non-Executive

Directors provide oversight of the policies implemented by leadership and monitor the overall

direction of the Company and its affiliated entities.

The Board remained actively engaged in overseeing the Company’s strategy throughout

2025 as ONWARD progressed further into its commercial phase and advanced key clinical

and regulatory initiatives. The Non-Executive Directors regularly reviewed strategic

priorities during Board meetings, with particular focus on commercial execution, regulatory

developments, clinical progress, and capital planning.

The Board received periodic updates on the commercialization of the ARC

system, including

market adoption, manufacturing readiness, and operational scaling. In addition, the Board

was kept informed of regulatory milestones, including U.S. and European approvals, as well

as preparations for and initiation of pivotal clinical activities for additional indications.

Discussions also addressed the Company’s funding position, liquidity planning, and potential

financing options. Through these regular updates and discussions, the Board maintained

effective oversight of key developments, challenges, and opportunities across the organization,

supporting informed decision-making and continued alignment with the Company’s long-term

strategic objectives.

Report of the

Non-Executive Directors

The Board has allocated certain specific responsibilities to the Audit Committee, Compensation

Committee, and Nomination and Corporate Governance Committee. Further details on how

these Committees have carried out their duties are set forth in the sections below pertaining

to each committee. The Non-Executive Directors have been regularly informed by each

committee of the results and recommendations of these meetings in accordance with best

practice provision 2.3.5 of the CGC, and the conclusions of those committees were considered

when drafting this report of the Non-Executive Directors. The Non-Executive Directors were

able to review and evaluate the performance of each Committee. There is no need to amend

the size or composition of any of the above committees.

Audit Committee

In 2025, the Audit Committee convened six times (see attendance details in the table below).

Throughout these meetings, the Committee reviewed and discussed key financial and

operational matters, including the financial reporting process, the full-year 2024 and half-

year 2025 results, internal control processes and ongoing enhancements, and the Company’s

funding and financing needs. In this context, the Audit Committee oversaw the design,

implementation and effectiveness of the Company’s risk management and internal control

systems, including those relating to financial reporting, operational and compliance risks.

The Audit Committee also evaluated the statements on internal control and risk management

included in the Annual Report ,including management’s assessment of the design and

operation of key controls and the outcomes of the annual risk review, and reviewed the

Company’s collaboration with its external auditor. The external auditor attended all meetings,

providing insights and presenting the audit plan for 2025.

197

ONWARD

Medical Annual Report 2025

Regular reports were provided to the Board of Directors, including recommendations and

guidance for approval where necessary. The Committee supported the Board in its oversight

of the Company’s risk management and internal control systems and related disclosures. The

Committee worked closely with the Management Team and finance department to ensure

effective oversight and implementation of key financial and governance initiatives, including

ongoing improvements to the internal control framework.

Compensation Committee

In 2025, the Compensation Committee met four times (see attendance details in the table

below), the Committee reviewed and approved the achievement of the 2024 company goals

and the corresponding variable remuneration for the Executive Director. It also oversaw the

preparation of the Compensation Report, which was subsequently approved by the Board and

included in the 2024 Annual Report. The Committee established the 2025 company goals and

objectives, monitoring progress throughout the year. Additionally, it reviewed and discussed

the remuneration policy, as well as the individual compensation arrangement. The Committee

also provided recommendations to the Board regarding the annual bonus payout for the

broader organization, the grant of long-term incentive plan (LTIP) options, and the proposed

salary increase pool for the annual merit review cycle. The Compensation Committee provided

regular reports to the Board of Directors, ensuring alignment and collaboration with the Board,

Management Team, and the People & Culture team as needed.

Nomination & Corporate Governance Committee

In 2025, the Nomination and Corporate Governance Committee met four times (see attendance

details in the table below). During the year, the Committee placed particular emphasis on

strengthening the composition of the Board and senior leadership team, including overseeing

the recruitment of new Board members and supporting the identification and appointment

of C-suite candidates for key roles. These efforts were aimed at ensuring the Company has

the appropriate skills, experience, and leadership capacity to support its strategic priorities

and continued growth. In addition, the Committee reviewed the Company’s human resources

and organizational strategy, considered succession planning for senior roles, and supported

the Board evaluation process, ensuring ongoing alignment with the Company’s long-term

objectives and governance standards.

The Nomination and Corporate Governance Committee provided regular updates to the

Board of Directors and collaborated closely with the Board, Management Team, and People

& Culture team as needed.

Evaluation

The Board is responsible for the quality of its own performance. Once per year, it discusses

its own performance and the performance of its individual members and committees.

Adhering to good governance, the Non-Executive Directors performed a Board effectiveness

assessment on a no-name basis in Q4 of 2025, based on a detailed questionnaire completed.

The assessment was facilitated by an external party in 2024 and the intention is to have an

external party facilitate once every 3 years.

The assessment focused on five categories of Board governance:

Information sharing between the Company and Board

Chairing of the Board and Board culture

Composition of the Board

4. Accountability

5. Standard of conduct

The Board evaluation reflects an overall positive view of Board effectiveness, with strong

alignment, engagement, and governance practices. Opportunities for further enhancement

were identified to support continued effectiveness and long-term value creation. The

outcomes were reviewed at the subsequent Board meeting.

Overall, it was determined that both the Board and its committees function effectively and

operate efficiently.

Report of the Non-Executive Directors

199

ONWARD

Medical Annual Report 2025

Internal Audit Function

Based on the recommendation of the Audit Committee, the Board determined that, given the

Company’s current size and stage of development, establishing a dedicated internal audit

function is not yet necessary. In reaching this conclusion, the Board considered the Company’s

existing governance and management processes that support the identification, monitoring,

and oversight of key risks and internal controls.

The Board is satisfied that these processes, together with regular reporting to and oversight

by the Audit Committee, provide an appropriate framework for risk management and internal

control at this stage. The Board will continue to periodically reassess the need for an internal

audit function as the Company grows and its operations further expand.

Independence of the Non-Executive Directors

Each Non-Executive Director is responsible for fulfilling their assigned duties with diligence

and acting in the best interests of the Company. In accordance with Dutch law, this corporate

interest encompasses the broader interests of all stakeholders, including shareholders,

creditors, and employees.

The Board confirms that the Non-Executive Directors meet the independence requirements

of the CGC. For details, refer to Director Independence included in the Governance section.

Report of the Non-Executive Directors

201

ONWARD

Medical Annual Report 2025

Board of Directors

Audit Committee

Compensation Committee

Nomination & Corporate

Governance Committee

Member & Principal Position

Independent

according to DCGC

% of attendance at

meetings

Member

Attendance % at

meetings

Member

Attendance % at

meetings

Member

Attendance % at

meetings

Dave Marver

Executive Director & CEO

100%

Rob Ten Hoedt

Non-Executive

Director & Chairperson

Yes

100%

Ian Curtis

Non-Executive

Director & Vice-Chairperson

Yes

100%

John de Koning

Non-Executive Director

80%

Kristina Dziekan

Non-Executive Director

Yes

100%

Vivian Riefberg

Non-Executive Director

Yes

100%

Rahma Samow

Non-Executive Director

Yes

100%

Tim Denison

Non-Executive Director

Yes

100%

Lucas Buchanan

Non-Executive Director

Yes

100%

Number of Meetings Held:

a: As Interim Director (expected to be nominated for appointment at our Annual General Meeting to be held in 2026), Tim has attended

all Board meetings since July 2025.

b: As Interim Director (expected to be nominated for appointment at our Annual General Meeting to be held in 2026), Lucas has

attended all Board and committee meetings since August 2025.

c: Rahma stepped down as member of the Audit Committee in Q3 2025 and was succeeded by Lucas.

2025

Meetings of the

Board & Committees

Report of the Non-Executive Directors

Board of

Directors’

Statements

205

ONWARD

Medical Annual Report 2025

The management report (Bestuursverslag), as defined in Article 2:391 of the Dutch Civil Code,

comprises the sections of this Annual Report designated as the management report, together

with those parts of the financial statements referred to therein.

This Annual Report has been prepared in accordance with International Financial Reporting

Standards (IFRS) as endorsed by the European Union, the statutory provisions of Part 9, Book

2 of the Dutch Civil Code, and applicable Dutch disclosure requirements.

To the best of our knowledge:

•

The consolidated and separate financial statements included in this Annual Report give

a true and fair view of the assets, liabilities, financial position and result of ONWARD

Medical N.V. and its consolidated subsidiaries;

•

The management report provides a true and fair view of the Company’s position at year-

end and of the development and performance of the business during the financial year.

The management team is responsible for establishing, implementing and maintaining

adequate risk management and internal control systems. The Board, through the Audit

Committee, oversees the design, implementation and effectiveness of these systems. These

systems are embedded in the Company’s business planning and review processes and are

designed to provide reasonable assurance regarding the reliability of financial reporting and

the preparation of financial statements in accordance with IFRS. The Company’s system of

internal control is structured with reference to the components of the COSO Internal Control

– Integrated Framework and also supports the identification and management of operational

and compliance risks.

Board of Directors’

Statements

During 2025, management further embedded the Company’s internal control framework

and assessed the design and operation of key controls, taking into account the Company’s

stage of development and the increasing scale of its commercial activities. The results of

this assessment and the annual risk review were discussed with the Audit Committee and

the Board and included financial reporting risks (including fraud and management override)

as well as operational and compliance risks.

Based on this assessment and the oversight performed, the Board considers the Company’s

risk management and internal control framework to be appropriate and proportionate to its

size, complexity and stage of development and notes that no deficiencies were identified that

would reasonably be expected to result in a material misstatement of the financial statements.

With reference to best practice provision 1.4.3 of the Dutch Corporate Governance Code, the

Board states that, to the best of its knowledge:

•

This report provides sufficient insight into the effectiveness of the internal risk

management and control systems in relation to the risks referred to in best practice

provision 1.2.1, and no material deficiencies have been identified.

•

That the internal risk management and control systems provides reasonable assurance

that the financial reporting does not contain material inaccuracies;

•

With respect to sustainability reporting, while the Company is currently not subject

to mandatory requirements, initial processes and controls are being developed and

provide limited assurance that sustainability information, where reported, is free from

material misstatements;

207

ONWARD

Medical Annual Report 2025

•

As at 31 December 2025, it is not aware that the internal risk management and control

systems do not provide sufficient comfort that operational and compliance risks are

effectively managed.

"Sufficient comfort" is to be read as: comfort considering our risk

appetite, the complexity of our enterprise, inherent limitations to these systems and

other disclosures on these systems in this report.

In this context, “effectively managed”

means that key risks are identified,

assessed and subject to mitigating measures, and

that material adverse impacts are

reduced to an acceptable level, although not

eliminated;

•

Based on the current state of affairs, it is justified that the financial statements are

prepared on a going concern basis

, refer to note 1.4 of the Consolidated Financial

Statements

;

•

This report includes the material risks and uncertainties

(refer to Risk Management and

Control section)

relevant to the Company’s expected continuity for a period of at least

twelve months after the preparation of this report.

The Company does not currently maintain a dedicated internal audit function. The Board

annually assesses whether alternative measures provide sufficient assurance over the

effectiveness of the Company’s risk management and internal control systems.

The Board recognizes that risk management and internal control systems cannot provide

absolute assurance and therefore provide reasonable, but not absolute, assurance. The inherent

limitations of these systems are considered in the Board’s oversight of their effectiveness.

The Board, supported by the Audit Committee, oversees the continued development of the

Company’s risk management and internal control framework as the business evolves.

Amsterdam, 30 March 2026

Board of Directors

Board of Directors’ Statements

Remuneration

Report

211

ONWARD

Medical Annual Report 2025

Remuneration

Report

This report provides an overview of the remuneration of the Board in 2025 and explains

how this relates to the Company’s policy regarding the remuneration of its Non-Executive

and Executive Directors (the Compensation Policy), which was previously adopted at the

Company’s 2024 Annual General Meeting (AGM). The adoption of the 2024 compensation

policy and report was through an advisory vote with 81% of voting in favor of adoption.

The 2025 Remuneration Report has been prepared in line with Section 2:135b of the Dutch Civil

Code (DCC) and best practice provision 3.4.1 of the Corporate Governance Code (CGC). This

report will be submitted to the AGM to be held in 2026 for an advisory vote. The Company’s

2026 AGM date will be announced after publication.

The Compensation Policy is available on the ONWARD website

(onwd.com)

under the

Investors/Governance tab.

213

ONWARD

Medical Annual Report 2025

Executive Director Remuneration

The annual remuneration of the Executive Director comprises the following two components:

•

Fixed remuneration, comprising an annual base salary and optional benefits, such

as medical insurance, life insurance, retirement benefits, travel expenses, and/or

representation allowances

•

Variable remuneration, comprising an annual performance-based compensation

(depending on the individual’s achievement and corporate objectives as defined on an

annual basis) and share-based remuneration

Fixed Remuneration

The amount of the fixed remuneration depends on the Executive Director’s function and

responsibilities and on typical compensation levels in the industry and the market, especially

in comparison to similar listed companies in the medical technology sector. The fixed

remuneration is paid out as a monthly salary.

Variable Remuneration

Short-term variable remuneration consists of annual performance-based compensation (a

bonus) defined on a yearly basis. The Company currently only considers corporate objectives..

Corporate objectives are focused on delivering commercial success in our first year of product

launch, alongside advancing key clinical, regulatory, and development milestones. These

objectives are measured via a set of specific targets to track progress and ensure alignment

with long-term growth.

Long-term variable remuneration consists of periodic grants of stock options that vest

monthly over a four-year vesting period. For more details, refer to Note 2.9 in the Consolidated

Financial Statements. Stock options create an ownership opportunity for executives linked to

the long-term performance of the Company’s share price, aligning their interests with those

of shareholders over the options’ 10-year term. If the share price does not increase from the

date of grant, no value is realized under the scheme.

Stock options are commonly leveraged as the primary equity vehicle among our industry

peer group in Europe and the US. Award sizes are determined at the point of grant in relation

to competitive award values and percentage of ownership delivered within our peer group.

The Company has implemented share-based remuneration as follows:

•

Share-based remuneration takes the form of options for shares

•

These options may not be transferred, pledged, or otherwise encumbered; subject to,

among others, the applicable yearly exercise periods, they may be exercised for up to 10

years after the grant date once vested

•

In cases of termination of an Executive Director’s management agreement (other than

termination by the Executive Director for good cause) who holds share options, or if that

Executive Director is dismissed, such options are subject to reverse vesting (and as such

will be forfeited) over a period of 36 months after their grant

•

This plan is not based on the achievement of specific performance-related Key

Performance Indicators (KPI’s); however, the size of the stock option grant is linked to

the position’s job grade and is contingent on an individual’s performance in the previous

calendar year

•

The plan is based on the premise that stock options contain an inherent performance

criterion for the recipient, who is invested in the successful performance of the Company,

thereby leading to an increase in the share price

There are no specific performance conditions associated with this plan, only a service

condition. This deviates from the requirements of best practice provision 3.1.2 v of the CGC.

In addition, refer to the section “Deviations from the Best Practices Provisions of the Dutch

Corporate Governance Code” of the Governance section for further information.

Remuneration Report

215

ONWARD

Medical Annual Report 2025

The following awards have been granted to the Company’s Executive Director. The main

conditions for exercising these options are described above.

Executive

Director

Financial

Year

Grant

Date

Type of

Security

Options

Vested /

Unvested

Exercise

Price

Expiration

Date

Dave Marver

2021

15/12/2021

Stock

Options

Vested:

188,000

Unvested:

–

€ 9.70

15/12/2031

Dave Marver

2023

03/01/2023

Stock

Options

Vested:

288,215

Unvested:

96,785

€ 6.12

03/01/2033

Dave Marver

2024

15/01/2024

Stock

Options

Vested:

147,083

Unvested:

152,917

€ 2.94

15/01/2034

Dave Marver

2024

05/12/2024

Stock

Options

Vested:

88,458

Unvested:

241,542

€ 4.77

05/12/2034

Dave Marver

2026

05/01/2026

Stock

Options

Vested:

Unvested:

630,000

€ 4.37

05/01/2036

Reduction or claw-back of variable remuneration

Pursuant to Dutch law, the variable remuneration of the Executive Director may be reduced,

or the Executive Director may be obliged to pay part of their variable remuneration to the

Company, if certain circumstances apply as follows:

•

Test of reasonableness and fairness: According to Dutch law, the Board may adjust

any variable remuneration payable to an Executive Director to an appropriate level if

payment of the variable remuneration is deemed unacceptable according to the criteria

of reasonableness and fairness

•

Claw-back: Under Dutch law, the Board has the authority to recover from an Executive

Director any variable remuneration paid based on incorrect financial or other data

Contribution to long-term performance & value creation

Remuneration of the Executive Director is consistent with and supports ONWARD’s strategy.

It also supports our ongoing efforts to improve our overall performance, facilitate growth and

sustainable success, and enhance our long-term value and interests.

As a result, our compensation packages are designed to enable us to compete in a global

market, including the challenging US labor market. We aim to attract top talent to execute

our long-term strategy and create sustainable value and growth in the best interest of the

Company and stakeholders. Executive compensation packages are reviewed annually

Q4, based on benchmarks provided by AON, an independent third party. No adjustment was

made to the executive compensation package for 2024.

Remuneration Report

217

ONWARD

Medical Annual Report 2025

Executive Director’s Remuneration

A detailed breakdown of the Executive Director’s remuneration is presented in the table below:

EUR’000

Dave Marver CEO

2025

2024

Base salary

440

425

Pension benefits

117

Other benefits

Total fixed compensation

588

544

31%

27%

Annual performance-based compensation

466

489

Exceptional bonus

–

250

Share-based remuneration / stock options

824

757

Total variable compensation

1,290

1,496

69%

73%

Total compensation

1,878

2,040

Scenario Analyses

A scenario analysis of the possible outcomes of the variable components and the impact

on the annual performance-based compensation was discussed by the Compensation

Committee in 2024 to assess if there are any risks that the performance criteria could lead to

inappropriate outcomes. The Compensation Committee concluded that the range of potential

remuneration outcomes were reasonable considering the current maturity and activities.

The Compensation Committee makes recommendations to the Board, however, the final

decision regarding percentages based on achievements relating to executive compensation

will remain up to the discretion of the Board.

Performance assessment

The Board determines the Executive Director’s variable remuneration (whereby the Executive

Director has not taken part in the discussions and decision-making by the Board) based on an

annual performance assessment and professional judgment. Variable remuneration is linked

to the individual’s performance against a set of financial and non-financial goals that supports

and is consistent with the Company’s strategy and long-term interests.

These goals include, among other topics, performance, business development, strategy,

investor relations, and general management. Risk alignment is considered in target setting

to promote sound and effective risk management. Variable remuneration is paid out according

to how the Company’s business develops, the scope of the Executive Director’s achievement,

and the realization of the Company’s general objectives.

In 2025, the Board approved a set of company goals for our Executive Director, containing

both financial and non-financial KPIs:

Commercialization

Drive ARC

Commercial Success and expand venues offering regulatory authorizations.

Advancing pipeline

Advance the Empower BP pivotal clinical trial by completing technical documentation,

securing regulatory approval, and enrolling the first study participant, while simultaneously

establishing a strategic roadmap for ARC

BCI

technology development.

Remuneration Report

219

ONWARD

Medical Annual Report 2025

Corporate

Extending cash runway through successful funding initiatives, ensuring financial stability

and operational continuity.

Performance criteria

functional area

Criteria

weight

On-target

performance

Actual

performance

Measured

performance

Commercialization

Advancing pipeline

Corporate

50%

35%

15%

100%

115%

74%

150%

58%

26%

23%

Total

106%

Corresponding amount

(EUR’000)

466

After the conclusion of the financial year, the Board assesses to what extent the performance

criteria have been met and determines the measured performance percentage and

corresponding amount for the Executive Director. Bonus compensation is at the discretion

of the Compensation Committee and, ultimately, the Board.

Evaluating the Executive Director’s performance against the performance criteria set forth at

the beginning of 2025, the Remuneration Committee recommended, and the Board granted

the CEO a variable compensation payout of 106% of target for 2025.

Non-Executive Director Remuneration

It should be in the Non-Executive Directors’ interest to focus on the Company’s sustainable and

long-term successful development. As such, the Company believes that fixed remuneration for

the Non-Executive Directors is effective. Regardless of their remuneration, all Non-Executive

Directors are entitled to reimbursement for their travel expenses.

The fees are as follows:

EUR’000

Chairman

Member

Board of Directors

Audit Committee

7.5

Compensation Committee

Nomination and Corporate Governance Committee

4.5

There were no changes to the fees for 2024.

Remuneration Report

221

ONWARD

Medical Annual Report 2025

Determination of Non-Executive Directors’ Remuneration

Non-Executive Director remuneration amounted to:

In EUR

Name

2025

2024

2023

2022

2021

Jan Øhrstrøm

–

130,765

160,889

208,134

533,577

Gregoire Courtine

304,081

661,177

512,297

300,725

980,918

Fred Colen

25,111

73,210

66,149

59,839

96,820

Kristina Dziekan

62,822

51,000

26,538

–

Vivian Riefberg

101,777

92,910

95,414

25,275

–

Rob Ten Hoedt

111,343

18,024

–

Rahma Samow

90,041

16,068

–

Tim Denison

28,161

–

Lucas Buchanan

f,g

37,441

–

Compensation includes the reimbursement of travel expenses.

a: Compensation includes cost of stock options EUR - (2024: EUR 26,421). Jan resigned from the board effective 6 December 2024.

b: Compensation includes the remuneration paid in relation to his role as Science Advisor EUR 93,521 (2024: EUR 347,430), as well as the

vesting of stock options under the long-term incentive plan EUR 205,858 (2024: EUR 313,747). Gregoire resigned from the board effective

4 July 2025.

Fred resigned from the Board effective 6 December 2024. Contractual remuneration following his departure was paid in 2025.

d: Compensation includes cost of stock options EUR 6,333 (2024: EUR 12,157).

e: Compensation includes cost of stock options EUR 7,529 (2024: EUR -).

f: Interim Director (expected to be nominated for appointment as Director at our Annual General Meeting to be held in 2026).

g: Compensation includes cost of stock options EUR 7,529 (2024: EUR -).

The following awards have been granted to the Company’s Non- Executive Director

Non-

Executive

Director

Financial

Year

Grant

Date

Type of

Security

Options

Vested /

Unvested

Exercise

Price

Expiration

Date

Grégoire

Courtine

2021

15/12/2021

Stock

Options

Vested:

62,000

Unvested:

–

€ 9.70

15/12/2031

Grégoire

Courtine

2023

03/01/2023

Stock

Options

Vested:

123,521

Unvested:

41,479

€ 6.12

03/01/2033

Grégoire

Courtine

2024

15/01/2024

Stock

Options

Vested:

61,285

Unvested:

63,715

€ 2.94

15/01/2034

Grégoire

Courtine

2024

05/12/2024

Stock

Options

Vested:

50,931

Unvested:

139,069

€ 4.77

05/12/2034

Vivian

Riefberg

2022

27/09/2022

Stock

Options

Vested:

13,044

Unvested:

2,956

€ 5.70

27/09/2032

Rahma

Samow

2025

12/08/2025

Stock

Options

Vested:

–

Unvested:

16,000

€ 4.11

12/08/2035

Lucas

Buchanan

2025

12/08/2025

Stock

Options

Vested:

–

Unvested:

16,000

€ 4.11

12/08/2035

Remuneration Report

223

ONWARD

Medical Annual Report 2025

Liability Insurance (D&O) and Indemnity

The Company maintains D&O insurance covering the Executive Directors and all Non-

Executive Directors.

Pursuant to Article 23 of the Articles of Association, the Directors are indemnified, held

harmless, and reimbursed by the Company for all expenses, financial effects of judgments,

fines, and amounts paid in settlement actually and reasonably incurred by them in connection

with an action, suit, proceeding, or investigation against them in their capacity as Executive

or Non-Executive Director.

Historical Development

The table below provides an overview of the annual compensation of the Executive Director

and full-time equivalent (FTE) employees for the financial years 2021 to 2025. The amounts

mentioned in the table are gross amounts before the impact of social-security or income-

tax deductions.

EUR’000

2025

2024

2023

2022

2021

2020

Net loss of the period

41,787

35,725

36,181

32,772

34,314

20,014

Executive Director

1,878

2,040

1,683

1,430

3,331

1,008

Annual change

-8%

21%

18%

-57%

230%

Average FTEs

122.05

99.36

104.5

86.6

76,7

Annual change

23%

-5%

21%

13%

-11%

Remuneration of FTEs

26,640

23,315

21,498

18,282

15,519

8,534

Annual change

14%

23%

18%

82%

Average remuneration per FTE

218

235

206

212

202

155

Annual change

-7%

12%

-3%

104%

Pay Ratio

Annual change

-1%

21%

-59%

62%

Non-Executive Directors

761

948

886

621

1,616

959

Annual change

-20%

43%

-62%

69%

a: The CEO was appointed on 1 July 2020.

b: For a meaningful comparison, as the CEO was appointed on 1 July 2020, the 2020 pay ratio was calculated by extrapolating the CEO

remuneration in 2020 for 12 months (EUR 2,016 thousand).

Remuneration Report

225

ONWARD

Medical Annual Report 2025

Pay Ratio

Based on best practice provision 3.4.1 of the DCGC, the Company shall disclose the pay ratio

between the remuneration of the Executive Directors and that of a representative reference

group of Company employees and, if applicable, comment on any important variation in pay

ratios compared to the previous financial year.

The reference group includes the Company’s entire workforce expressed in the form of full-

time equivalent (FTE) employees. The FTE of each employee is calculated based on the

number of hours an employee works in each period, compared to the maximum number of

hours/periods allowed, as per the local law prevalent in the country of operation. As of 31

December 2025, there were 137.3 FTEs (2024: 102.55).

Pay ratios are calculated based on the average remuneration received by employees of the

reference group. The remuneration taken into account is the amount received during the year

concerned. If all or part of the remuneration was paid in a foreign currency, the exchange rate

used was the average exchange rate of the relevant currency into euros for the year ending

31 December 2025.

The Company used both fixed and variable remuneration components in determining the pay

ratio for a given year. The pay ratio disclosed by the Company reflects the previous financial

year. The average Executive Director-to-employee pay ratio stands at 9 in 2025, similar to

2024 with no variance. The variance from 2023 to 2024 is due to an increase in the cost per

FTE, and the exceptional bonus approved by the Board for the CEO following the successful

fundraising in October 2024.The variance from 2022 to 2023 is driven by the cost of stock

options awarded on 3 January 2023, this is a non-cash component of the CEO’s variable

compensation. The variance from 2020 to 2021 and 2021 to 2022 is due to the successful IPO

in October 2021 that positively impacted the performance-based remuneration and triggered

the accelerated vesting of the Employee Investment Plan.

Remuneration Report

Financials

Consolidated Statement

of Proﬁt & Loss

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Revenue

2.1

3,740

Grants & Other Income

2.1

1,674

1,662

5,414

1,739

Cost of goods sold

(1,039)

(22)

Gross Proﬁt

4,375

1,717

Research & Development Expenses

2.2,2.7

(12,318)

(13,883)

Clinical & Regulatory Expenses

2.3,2.7

(5,730)

(4,754)

Marketing & Market Access Expenses

2.4,2.7

(8,118)

(3,350)

Quality Assurance Expenses

2.5,2.7

(2,362)

(2,016)

General & Administrative Expenses

2.6,2.7

(16,763)

(12,576)

Total Operating Expenses

(45,291)

(36,579)

229

ONWARD

Medical Annual Report 2025

Consolidated Financial Statements

231

Operating Loss for the Period

(40,916)

(34,862)

Financial Income

4.5

1,691

1,165

Financial Expense

4.5

(2,251)

(2,068)

Net Finance Expense

(560)

(903)

Loss for the Period Before Taxes

(41,476)

(35,765)

Income Tax

2.9

(311)

Net Loss for the Period

(41,787)

(35,725)

Attributable to:

Equity holders of the parent

(41,787)

(35,725)

(41,787)

(35,725)

Earnings Per Share (EUR):

Basic earnings per share:

4.1

(0.90)

(0.80)

Diluted earnings per share:

4.1

(0.90)

(0.80)

ONWARD

Medical Annual Report 2025

Consolidated Financial Statements

233

Consolidated Statement

of Comprehensive Income

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Net Loss for the Period

(41,787)

(35,725)

Remeasurement of post-employment benefits

5.0,2.9

(491)

(1,565)

Other comprehensive income that will not be

reclassiﬁed to proﬁt or loss in subsequent pe-

riods (net of tax)

(491)

(1,565)

Currency translation differences

(1,045)

434

Other comprehensive income that will be

reclassified to profit or loss in subsequent

periods (net of tax)

(1,045)

434

Total Comprehensive Result for the Year, Net of

(43,323)

(36,856)

Tax

Attributable to:

Equity holders of the parent

(43,323)

(36,856)

Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

235

Consolidated Statement

of Financial Position

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Assets

Non-Current Assets

Intangible assets

3.0

8,733

10,425

Property, plant & equipment

3.1

534

471

Right of use assets

3.2

551

1,054

Deferred tax assets

2.9

659

568

10,477

12,518

Current Assets

Inventories

3.3

803

102

Indirect tax receivables

3.4

381

125

Receivable from related parties

–

Trade and other receivables

3.5

1,195

160

Other current assets

3.6

3,587

3,153

Cash and cash equivalents

3.7

68,110

60,043

74,076

63,619

Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

84,553

76,137

Equity & Liabilities

Equity & Reserves

Issued capital

4.0

6,721

5,355

Share premium

4.0

264,354

217,774

Other reserves*

4.0

6,799

6,770

Retained earnings

(222,558)

(181,845)

Total Equity Attributable to Shareholders

55,316

48,054

Non-Current Liabilities

Interest-bearing loans

4.2

13,074

13,972

Deferred tax liability

2.9

347

303

Lease liability

3.2

518

Post-employment benefits

5.0

4,664

3,999

18,138

18,792

Current Liabilities

Income tax liabilities

179

200

Lease liability

3.2

538

597

Trade payables

3.8

3,083

1,269

Other financial liabilities

4.2

370

437

Payable to related party

–

Other payables

6,878

6,788

3.9

11,099

9,291

84,553

76,137

*Other reserves include the foreign currency translation reserve that qualifies as a legal reserve under Dutch Law.

237

Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Consolidated Statement

of Changes in Equity

All amounts in EUR ‘000

Notes

Issued Capital

Share Premium

Other Reserves*

Retained Earnings

Total Equity

As at 1 January 2024

3,622

155,249

4,488

(145,428)

17,931

Loss for the year 2024

–

(35,725)

Other comprehensive income

–

434

(1,565)

(1,131)

Total comprehensive result

–

434

(37,290)

(36,856)

Issuance of share capital

4.0

1,733

68,267

–

70,000

Transaction costs related to issue of share capital

4.0

(5,742)

–

(5,742)

Share-based payments: LTIP

2.8, 4.0

–

1,847

873

2,720

As at 31 December 2024

4.0

5,355

217,774

6,770

(181,845)

48,054

As at 1 January 2025

5,355

217,774

6,770

(181,845)

48,054

Loss for the year 2025

–

(41,787)

Other comprehensive income

–

(1,045)

(491)

(1,536)

–

Total comprehensive result

–

(1,045)

(42,278)

(43,323)

Issuance of share capital

4.0

1,356

49,494

–

50,850

Transaction costs related to issue of share capital

4.0

–

(3,241)

–

(3,241)

Exercise of options

2.8

327

–

337

Share-based payments: LTIP

–

1,074

1,565

2,639

2.8, 4.0

–

As at 31 December 2025

4.0

6,721

264,354

6,799

(222,558)

55,316

239

Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

* Other reserves include the foreign currency translation reserve that qualifies as a legal reserve under Dutch Law.

Consolidated Statement

of Cash Flows

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Cash Flows from Operating Activities

Loss for the Period Before Taxes

(41,476)

(35,765)

Adjusted for:

•

Depreciation and impairment of property, plant and

3.0, 3.1, 3.2

1,447

898

equipment and right-of-use assets

•

Share-based payment transaction expense

2.8

2,639

2,720

•

Post-employment benefits

126

•

Net finance costs

560

902

•

Other non-cash items

148

143

Changes in working capital:

Increase (-) Decrease (+) in Trade and other receivables

(2,905)

(1,857)

Increase (+) Decrease (-) in Trade and other payables

1,955

2,313

241

Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

243

Interest received

496

686

Interest paid

(1,661)

(1,742)

Income tax paid

(257)

(167)

Bank charges paid

4.5

(61)

(20)

Net cash(used)/generated

from operating activities

(39,066)

(31,763)

Cash flows from investing activities

Investments in fixed assets

3.1

(432)

(150)

Net cash generated/(used) from investing activities

(432)

(150)

Cash flows from financing activities

Proceeds from interest-bearing loans

4.2

–

14,116

Repayment of principal portion of interest-bearing loans

4.2

–

(15,255)

Payment of principal portion of lease liabilities

3.2

(600)

(560)

Proceeds from exercise of share options

337

–

Proceeds from issuance of shares

4.0

50,850

70,000

Transaction costs on issuance of shares

4.0

(3,241)

(5,741)

Net cash generated/(used) from financing activities

47,346

62,560

Movement in cash and cash equivalents

Cash and cash equivalents at 1 January

60,043

29,768

Effect of exchange rates on cash and cash equivalents

220

(372)

Changes in cash and cash equivalents during the period

7,847

30,647

Cash and cash equivalents at 31 December

3.7

68,110

60,043

ONWARD

Medical Annual Report 2025

Consolidated Financial Statements

Notes to the

Consolidated

Financial

Statements

Notes to the Consolidated

Financial Statements

ONWARD

Medical Annual Report 2025

247

1. General Information & Basis of Preparation

1.0 Corporate Information

General

Onward Medical N.V. (“ONWARD”) is a public limited company under Dutch law (naamloze

vennootschap). The registered office is located at Schimmelt 2, Eindhoven, the Netherlands.

ONWARD is registered in the Commercial Register of the Chamber of Commerce under

number 64598748.

ONWARD and its subsidiaries (the “Group”) are developing and commercializing innovative

therapies to enable functional recovery for people with Spinal Cord Injury (“SCI”). The

Company’s technology platforms are based on ONWARDARC Therapy (“ARC Therapy”),

targeted, programmed electrical stimulation of the spinal cord designed to restore movement,

independence, and health in people with SCI.

The financial statements for the year ended 31 December 2025 have been prepared by the

Board of Directors and were authorized for issue on 30 March 2026. The financial statements

will be submitted for adoption to the 2026 Annual General Meeting.

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

249

1.1 Group Information

Information about subsidiaries

The consolidated financial statements of the Group include:

•

ONWARD Medical SA, Switzerland (holding 100%)

•

ONWARD Medical Inc, United States of America (holding 100%)

1.2 Basis of Preparation

The consolidated financial statements of the Group have been prepared in accordance with

International Financial Reporting Standards (IFRS) and IFRIC interpretations as adopted

by the European Union and with Part 9 of Book 2 of the Dutch Civil Code.

The consolidated financial statements have been prepared on a historical cost basis,

unless otherwise stated. Income and expenses are accounted for on an accrual basis.

The consolidated financial statements provide comparative information in respect of the

previous period.

The consolidated financial statements are presented in euros and all values are rounded to

the nearest thousand (EUR 000), except when otherwise indicated, and for the number of

shares and the per share amount. Due to rounding, amounts may not add up to totals provided.

1.3 Basis of Consolidation

The consolidated financial statements comprise the financial statements of the Group and

its subsidiaries as at 31 December 2025. Control is achieved when the Group is exposed,

or has rights, to variable returns from its involvement with the investee and has the ability

to affect those returns through its power over the investee. Specifically, the Group controls

an investee if and only if the Group has:

•

Power over the investee (i.e., existing rights that give it the current ability to direct the

relevant activities of the investee)

•

Exposure, or rights, to variable returns from its involvement with the investee, and

•

The ability to use its power over the investee to affect its returns

The Group reassesses whether or not it controls an investee if facts and circumstances

indicate that there are changes to one or more of the three elements of control. Consolidation

of a subsidiary begins when the Group obtains control over the subsidiary and ceases when

the Group loses control of the subsidiary.

Profit or loss and each component of other comprehensive income (OCI) are attributed to

the equity holders of the parent of the Group. When necessary, adjustments are made to

the financial statements of subsidiaries to bring their accounting policies into line with the

Group’s accounting policies. All intragroup assets and liabilities, equity, income, expenses,

and cash flows relating to transactions between members of the Group are eliminated in

full-on consolidation.

1.4 Going Concern

In preparing the consolidated financial statements for the year ended 31 December 2025,

management evaluated the Company’s ability to continue as a going concern by reviewing

projected cash flows for at least the twelve months following the approval of the financial

statements. These projections reflect planned investments in research and development,

ongoing and planned clinical programs, commercial activities, regulatory activities, and the

servicing of existing financial obligations.

As of 31 December 2025, the Company held cash and cash equivalents of EUR 68 million and

had incurred cumulative losses of EUR 223 million since inception. Based on current forecasts

and planned expenditures, management expects that existing cash resources will support

the Company’s operations for a significant portion of the twelve-month assessment period

but are not expected to be sufficient to fund operations for the full twelve months following

approval of the financial statements without additional measures. However, this outlook is

dependent on a number of assumptions and is subject to material uncertainty.

251

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

During 2025 and subsequent to the reporting date, the Company achieved important

operational milestones, including continued commercial progress of the ARC

System and the

receipt of additional regulatory approvals, which expand the potential addressable market.

Notwithstanding this progress, the Company remains in the early stages of commercialization,

and there is limited historical data available to support revenue forecasts. As a result, actual

revenues and the timing of cash inflows may differ from current expectations.

The Company is also subject to risks associated with its financing arrangements. The Company

has an outstanding loan facility with Runway Growth that includes minimum quarterly revenue

and EBITDA performance thresholds. Based on current forecasts, a potential covenant

breach is anticipated towards the end of the third quarter of 2026 if no amendments to the

covenant terms are agreed. The Company has previously obtained two amendments to the

covenant terms under this facility and has initiated discussions with Runway Growth regarding

a potential further amendment and/or extension. As of the reporting date, the Company

remains in compliance with all covenants. In the event of a covenant breach, Runway Growth

would have the right, but not the obligation, to declare the loan immediately due and payable,

subject to a contractual cure period of 30 days. Management recognizes that future operating

performance, liquidity levels, or broader market conditions could affect the Company’s

ability to maintain compliance with covenant requirements. Based on the Company’s prior

experience of obtaining covenant amendments and the constructive discussions currently

underway with the lender, management considers it reasonable to expect that an appropriate

solution can be agreed before any potential covenant breach occurs.

To address these uncertainties, management has identified a range of mitigating actions

within its control. These include the ability to manage and reduce cash outflows through

disciplined cost control, reprioritization or deferral of certain research, clinical, or commercial

activities, and adjustments to the timing of hiring and other discretionary expenditures. In

particular, expenditures related to the ARC

program and ongoing ARC

development

can be actively managed and adjusted as part of the Company’s cost-control measures,

which would not be in the Company’s long-term interest. In addition, management continues

to evaluate financing options to support the Company’s strategic plans and longer-term

liquidity requirements, including the potential to attract additional equity or debt financing.

Management also continues to focus on accelerating commercial adoption of the ARC

System to increase revenue and associated cash inflows. These actions are supported by the

Company’s demonstrated ability to manage expenditures and secure funding when required.

Notwithstanding these mitigating actions, the combination of uncertainty surrounding future

cash inflows, the potential for a future covenant breach under the Runway Growth loan facility,

and the current expectation that existing cash resources alone may not be sufficient to fund

operations for the full twelve months following approval of the financial statements gives

rise to a material uncertainty that may cast significant doubt on the Company’s ability to

continue as a going concern.

Nevertheless, taking into account the Company’s cash position at year end, planned mitigating

actions, and management’s assessment of available options, the consolidated financial

statements have been prepared on a going concern basis.

1.5 Summary of Material Accounting Policies

a. Current versus non-current classification

The Group presents assets and liabilities in the statement of financial position based on

current/non-current classification. An asset is current when it is:

•

Expected to be realized or intended to be sold or consumed in normal operating cycle

•

Held primarily for the purpose of trading

•

Expected to be realized within twelve months after the reporting period, or

•

Cash or cash equivalent unless restricted from being exchanged or used to settle a

liability for at least twelve months after the reporting period

All other assets are classified as non-current.

A liability is current when:

•

It is expected to be settled in normal operating cycle

•

It is held primarily for the purpose of trading

253

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

•

It is due to be settled within twelve months after the reporting period, or

•

There is no unconditional right to defer the settlement of the liability for at least twelve

months after the reporting period

The Group classifies all other liabilities as non-current.

Deferred tax assets and liabilities are classified as non-current assets and liabilities.

b. Foreign currencies

The Group’s consolidated financial statements are presented in euros, which is also the

parent company’s functional currency. For each entity, the Group determines the functional

currency and items included in the financial statements of each entity are measured using

that functional currency.

Transactions and balances

Transactions in foreign currencies are initially recorded by the Group entities at their respective

functional currency spot rates at the date the transaction first qualifies for recognition.

Monetary assets and liabilities denominated in foreign currencies are retranslated at the

functional currency spot rate of exchange at the reporting date.

Differences arising on settlement or translation of monetary items are recognized in profit

or loss with the exception of monetary items that are designated as part of the hedge of the

Group’s net investment of a foreign operation. These are recognized in other comprehensive

income until the net investment is disposed of, at which time, the cumulative amount is

reclassified to profit or loss. Tax charges and credits attributable to exchange differences

on those monetary items are also recorded in other comprehensive income.

Non-monetary items that are measured in terms of historical cost in a foreign currency are

translated using the exchange rates as at the dates of the initial transactions. Non-monetary

items measured at fair value in a foreign currency are translated using the exchange rates

at the date when the fair value is determined. The gain or loss arising on translation of non-

monetary items measured at fair value is treated in line with the recognition of gain or loss

on change in fair value of the item (i.e., translation differences on items measured at fair

value are recognized in the same line as the related fair value gains or losses, either in other

comprehensive income or in profit or loss).

Any goodwill arising on the acquisition of a foreign operation and any fair value adjustments

to the carrying amounts of assets and liabilities arising on the acquisition are treated as

assets and liabilities of the foreign operation and translated at the spot rate of exchange at

the reporting date.

Group companies

On consolidation, the assets and liabilities of foreign operations are translated into euros

at the rate of exchange prevailing at the reporting date and their income statements are

translated at the monthly average exchange rates.

The exchange differences arising on translation for consolidation are recognized in

other comprehensive income. On disposal of a foreign operation, the component of other

comprehensive income relating to that particular foreign operation is recognized in profit

or loss.

1.6 Significant Accounting Judgments, Estimates & Assumptions

The preparation of the Group’s consolidated financial statements requires Management to

make judgments, estimates, and assumptions that affect the reported amounts of certain

expenses, assets and liabilities, and the disclosure of contingent liabilities, at the end of the

reporting period. However, uncertainty about these assumptions and estimates could result

in outcomes that require a material adjustment to the carrying amount of the asset or liability

affected in future periods.

The Group based its assumptions and estimates on parameters available when the

consolidated financial statements were prepared. Existing circumstances and assumptions

about future developments, however, may change due to market changes or circumstances

arising beyond the control of the Group. Such changes are reflected in the assumptions when

they occur.

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

255

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to

accounting estimates are recognized in the period in which the estimate is revised if the

revision affects only that period, or in the period of revision and the future periods if the

revision affects both current and future periods.

The key assumptions concerning the future and other key sources of estimation uncertainty

at the reporting date, that are most relevant to the carrying amounts of assets and liabilities

within the next financial year, are included in each of the respective notes as referenced below:

Share-Based Payments	Note 2.8
Post-Employment Benefits	Note 5.0
Taxes	Note 2.9

1.7 New Accounting Standards & Developments

1.7.1 New and Amended Standards and Interpretations

The following amendment applied for the first time in 2025:

•

Lack of exchangeability – Amendments to IAS 21, effective 1 January 2025

This amendment

had no impact on the consolidated financial statements of the Group

in 2025.

1.7.2 Standards Issued but Not Yet Effective

The new and amended standards and interpretations that are issued, but not yet effective,

up to the date of issuance of the Group’s financial statements are listed below. The Group

has not early adopted any standards, interpretations or amendments that have been issued

but are not yet effective. The Group intends to adopt new and amended standards and

interpretations, if applicable, when they become effective.

•

Classification and Measurement of Financial Instruments - Amendments to IFRS 9 and

IFRS 7, effective 1 January 2026.

•

Contracts Referencing Nature-dependent Electricity – Amendments to IFRS 9 and IFRS

7, effective 1 January 2026.

•

IFRS 18 – Presentation and Disclosure in Financial Statements, effective date

1 January 2027.

•

IFRS 19 - Subsidiaries without Public Accountability: Disclosures, effective date

1 January 2027.

•

Translation to a Hyperinflationary Presentation Currency - Amendments to IAS 21,

effective date 1 January 2027.

•

Sale or Contribution of Assets between an Investor and its Associate or Joint Venture

- Amendments to IFRS 10 and IAS 28. In December 2015, the IASB postponed the

effective date of this amendment indefinitely pending the outcome of its research

project on the equity method of accounting.

With the exception of IFRS 18 which is being further assessed, based on the nature and impact

of the remaining new standards, amendments and/or interpretations, the Group expects no

material impact considering the circumstances as at the date of this Annual Report.

1.8 Changes in Accounting Policies and Disclosures

1.8.1 Change in Disclosure in the Consolidated Statement of Profit and Loss in 202

During the year ended 31 December 2025, the Group reassessed the presentation of certain

operating expense line items in the consolidated statement of profit or loss in accordance

with IAS 1 Presentation of Financial Statements. As a result of this reassessment, patent

and related intellectual property costs are now presented within Research and Development

(“R&D”) expenses, rather than as a separate line item on the face of the consolidated

statement of profit or loss.

Patent and related expenses primarily comprise costs incurred to secure, maintain and

defend intellectual property associated with the Group’s technology platform, including

patent filing, prosecution, maintenance and related advisory fees. Management determined

257

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

that these costs are directly attributable to and arise from the Group’s development activities

and are integral to protecting and advancing its product pipeline. Accordingly, presenting

these expenses within R&D better reflects the nature and function of the costs within the

Group’s operations.

The revised presentation enhances the relevance and faithful representation of the Group’s

performance by aligning the classification of intellectual property protection costs with the

underlying research and development activities from which they originate. In addition, this

presentation is consistent with industry practice within the industry, where patent-related

expenditures that support product development are commonly included within R&D expenses,

thereby improving comparability with peers.

The change relates solely to presentation within operating expenses and has no impact on

total operating expenses, operating loss, loss for the year, earnings per share, cash flows

or the financial position of the Group. Comparative information has been re-presented to

conform with the current year presentation.

	Reported:	Restated:	Change
	2024	2024
Research & Development expenses	12,442	13,883	1,441
Patent fees & Related Expenses	1,441	–	(1,441)

The following note was restated:

	Reported:	Restated:	Change
	2024	2024
2.2 Research & Development expenses
Staff costs	9,260	9,260	–
Outsourced cost	3,182	4,623	1,441
	12,442	13,883	1,441

And the following note has been removed:

	Reported:	Restated:	Change
	2024	2024
2.5 Patent and Related expenses
Staff costs	–	–	–
Outsourced cost	1,441	–	(1,441)
	1,441	–	(1,441)

259

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

2. Results of The Year

2.0 Segment Reporting

Based on the organizational structure, as well as the nature of financial information available

and reviewed by the Company’s chief operating decision-makers to assess performance

and make decisions about resource allocations, the Company has concluded that its total

operations represent one reportable segment and that the consolidated disclosures address

the requirements.


	2025	2024
Non-current assets
Netherlands	159	105
Switzerland	1,453	2,077
United States of America	8,865	10,336
Non-current assets	10,477	12,518

For the geographical information on revenue from external customer, please refer to Note

2.1 below.

2.1 Revenues & Other Income

Accounting policy:

Sale of ARC

Medical Devices

ONWARD Medical recognises revenue in accordance with IFRS 15 when control of the ARC

medical device is transferred to the customer, at an amount that reflects the consideration

to which the Group expects to be entitled.

Nature of the Arrangement

Contracts with customers consist primarily of the sale of the ARC

system. The Group has

concluded that it acts as principal, as it controls the device prior to transfer to the customer.

The accompanying software is required for the device to function as intended and is provided

as an integral component of the system under a perpetual end-user licence, with no separate

pricing or ongoing service obligation.

Performance Obligations

The sale of the ARC

system represents a single performance obligation, comprising the

hardware and embedded/permitted software necessary to operate the device. No separate

performance obligations are identified, as:

•

the software is not sold separately and cannot be used independently of the device, and

•

standard warranties provided are assurance-type warranties only and do not constitute

a distinct service.

Timing of Revenue Recognition

Revenue primarily consists of the sale of ARC

systems under contractually agreed terms

and conditions. Depending on the contract, the Company obtains a right to payment upon

shipment or delivery of the systems, with payment terms typically ranging from 30 to 90 days.

Revenue is recognised at a point in time when control of the system transfers to the customer,

which generally occurs upon shipment from the Company’s facility. While the transfer of risks

and rewards is not the only criterion, it is typically the main indicator of control and generally

coincides with the transfer of legal title, risk of loss and the customer’s obligation to pay in

accordance with the contract.

Variable Consideration, returns and volume rebates

Contracts include limited rights of return, subject to strict conditions. The Group assesses

expected returns at contract inception and recognises variable consideration only to the

extent that it is highly probable that a significant revenue reversal will not occur. Where

applicable, a refund liability and corresponding right-of-return asset are recognised.

261

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Certain customer contracts include volume-based rebates or sales incentives that depend

on achieving specified purchase or performance thresholds. These arrangements give rise

to variable consideration, which the Group estimates based on the expected or most likely

outcome and includes in revenue only to the extent that it is highly probable that a significant

reversal will not occur. Revenue is recognised net of estimated rebates or incentives, with a

corresponding refund liability recorded for amounts expected to be payable to customers.

Sales incentives that are earned based on performance in one period but applied to future

purchases are recognised as a reduction of revenue when the related performance conditions

are met.

Significant financing component

The Group applies the practical expedient for short-term advances received from customers.

That is, the promised amount of consideration is not adjusted for the effects of a significant

financing component if the period between the transfer of the promised good or service and

the payment is one year or less.

Warranties

The ARC

system is subject to a standard limited warranty covering defects in materials

and workmanship. This warranty provides assurance that the product complies with agreed

specifications and does not represent a separate performance obligation. Expected warranty

costs will be accounted for separately as a provision in accordance with IAS 37. No warranty

claims were reported in 2025, and no provision has been recognised, as there is no historical

claims experience indicating material warranty obligations.

Government subsidies and grant income

Government subsidies and grant income are recognized where there is reasonable assurance

that the amount will be received, and all attached conditions will be complied with. When the

subsidy or grant relates to an expense item, it is recognized as income on a systematic basis

over the periods that the related costs, for which it is intended to compensate, are expensed.

Any outstanding receivables related to these subsidies or grants are recorded as grants

receivable. The government subsidies and grants are presented on a gross basis except for

the WBSO (“Wet Bevordering Speur & Ontwikkeling”) that is presented on a net basis with

the expensed amount for personnel expenses.

	2025	2024
Revenue from sale of devices	3,740	77
Government subsidies	1,634	1,510
Other income	40	152
Total revenues and other income	5,414	1,739

Sales per geography

	2025	2024
United State of America	3,231	77
Europe*	334	–
Rest of the World*	175	–
Total sales of devices	3,740	77

*Revenue recorded in Onward Medical NV (in the Netherlands)

For the year ended December 31, 2025, the Group has no customers with individual sales

larger than 10% of the total revenue. All revenue from the sale of devices in 2024 occurred in

the United States of America.

Government subsidies have been received for the research and development of several

development projects. There are no unfulfilled conditions or contingencies attached to

these subsidies.

263

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

				Recognized	Grant
		Recognized	Recognized	as Grant	received in
	Total	as Grant	as Grant	Income	advance as
Grants	Grant a	Income 2025	Income 2024	cumulative	per 31-12-
				before 2024	2025
BESTABLE e	100	–	(16)	100	–
SWISS LOCAL (one-offs) b	–	–	22	150	–
EISMEA – ReverseParalysis e	292	2	232	36	–
SERI - Reverse Paralysis b,c	997	4	970	0	–
EISMEA - NEMO BMI e	187	95	–	0	(13)
SERI – NEMO BMI b,c	882	873	–	–	–
Eurostars Impulse e	500	176	150	174	–
Rewire e	360	74	50	56	(38)
SH-ARC e	500	64	-	53	(296)
MJFF SPARKL e	91	–	91	–	–
PD-HemoN project d	224	59	11	–	(112)
PD- Bridge Mobility d	278	22	–	–	–
EISMEA – Reverse Stroke e	686	–	–	–	(240)
SERI – Reverse Stroke b,c	1,129	265	–	–	(296)
Other e	–	–	–	(12)	–
Total		1,634	1,510	557	(995)

a: Please refer to the terms and conditions of the subsidies included below.

b: These grants were received by ONWARD Medical SA (In Switzerland)

c: Grant is received in CHF and is converted to EUR using closing rate

d: These grants were received by ONWARD Medical Inc (In the United States of America)

e: These grants were received by ONWARD Medical NV (In the Netherlands)

Terms & conditions

BESTABLE

This Eurobench funding agreement with PKF ATTEST INNCOME S.L. and the Spanish National

Research Council CSIC for a total amount of €100k started in September 2019 and ended

in December 2021. An amount equal to 85% of the grant is paid during the grant period in

tranches in 2019, 2020 and 2021. The remaining 15% of the total grant amount is payable after

evaluation of the final report. In this project, ONWARD is collaborating with the Technical

University of Delft and the University Rehabilitation Institute to develop a benchmarking

system for assessment of balance performance. The final 15% was not received by the end

of 2024 and the amount previously recognized was reversed in 2024.

Reverse Paralysis

The European Innovation Council and SMEs Executive Agency (EISMEA) awarded a €3.6

million grant (EIC Transition, 101057450)

to support the development of innovative Brain-

Spine Interface technology aimed at restoring mobility and upper limb function. ONWARD,

along with research partners

EPFL, CEA-Clinatec, and Sint Maartenskliniek, is participating

in this project, of which €1.3 million was originally allocated to ONWARD and subsequently

adjusted to €292 thousand. The project commenced on 1 May 2022, and concluded in 2025

as planned. Due to changes in ONWARD’s research footprint, a portion of the work originally

planned in the Netherlands has shifted to Switzerland, affecting the eligibility of certain

costs under the EISMEA framework. To address this, ONWARD successfully negotiated an

amendment with EISMEA to transfer activities and secured replacement funding from the

Swiss State Secretariat for Education, Research, and Innovation (SERI) to cover activities

performed in Switzerland.

NEMO BMI

The EISMEA also awarded a €3.8 million grant for the development of Motor Brain-Machine

Interfaces (BMIs) (EIC Pathfinder, 101070891). These interfaces translate brain neural signals

into commands for external effectors, with the NEMO BMI project focusing on assistance-

free, portable neuroprosthetics, including a wireless neuronal activity recorder, a real-time

neuronal decoder, and a spinal cord stimulator. The project, involving ONWARD and partners

265

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

EPFL, CEA, and IICT, began on 1 October 2022, and activities are expected to continue until

30 September 2026. ONWARD’s share of the original grant was €1 million and subsequently

adjusted to €187 thousand. Due to changes in ONWARD’s research footprint, a portion of the

work originally planned in the Netherlands has shifted to Switzerland, affecting the eligibility

of certain costs under the EISMEA framework. To address this, ONWARD successfully

negotiated an amendment with EISMEA to transfer activities and secured replacement

funding from the Swiss State€Secretariat for Education, Research, and Innovation (SERI)

to cover activities performed in Switzerland.

Eurostars Impulse

The Eurostars Independent Evaluation Panel has provided a subsidy for a total amount of

€500 thousand that started 1 December 2022 and ended 30 November 2025, a duration

of 36 months. The Impulse project focuses on closed-loop control of blood pressure for

people with SCI.

ReWIRE

ONWARD has joined other global neuroscience and rehabilitation stakeholders to create

ReWIRE, a groundbreaking initiative aimed at equipping next-generation scientists with the

skills to develop therapeutic solutions for patients with paralysis caused by SCI. ReWIRE

will build on recent technological breakthroughs by leveraging multiple PhD projects that

will drive effective combinatorial treatments for SCI. The project is funded by the European

Research Executive Agency (REA) as part of the Marie Skłodowska-Curie Actions (MSCA)

Doctoral Networks for an amount of €360 thousand and started in 1 January 2023 and ends

31 December 2026.

SH-ARC

The Eurostars Independent Evaluation Panel has provided a subsidy for a total amount of

€500 thousand that started 1 April 2023 and ends 31 March 2026, a duration of 36 months.

SH-ARC works to integrate NUSHU sensorised shoes in a clinical-grade neuroprosthesis

that will utilize spinal cord stimulation to alleviate parkinsonian gait deficits.

MJFF - SPARKL

ONWARD Medical and it’s partner .NeuroRestore have received approximately €900

thousand from the Michael J. Fox Foundation for Parkinson’s Research. This grant will

support a clinical feasibility study with 6 participants to explore the ability of the ONWARD

ARC

System to address mobility challenges in Parkinson’s disease. ONWARD’s allocation

amounts to €90 thousand. The study commenced on 01 January 2023, with the first

participant implanted in late 2024, and the project will end 13 December 2025.

PD-HemON

ONWARD Medical and its research partner, .NeuroRestore, have received approximately

€1.5 million from the US Department of Defense (DoD), Parkinson’s Research Program (PRP)

Investigator-Initiated Research Award (IIRA). This funding will support a clinical feasibility

study with 5 participants to explore the ability of the ONWARD ARCIM System to address

blood pressure instability in Parkinson’s disease. ONWARD will receive €224 thousand. The

project started on 30 September 2024 and will continue until 29 September 2027.

PD-Bridge Mobility

ONWARD Medical and its research partner, .NeuroRestore, have been award an

approximately €1.8 million grant from the US Department of Defense (DoD), Parkinson’s

Research Program (PRP), Investigator-Initiated Research Award (IIRA). The funding supports

additional patients in an on-going trial to study ONWARD ARC

Therapy on gait deficits

in Parkinson’s disease. ONWARD will receive €278 thousand. The project started on 01

September, 2025 and will end on 31 August, 2028.

ReverseStroke

The European Innovation Council and SMEs Executive Agency (EISMEA) awarded an almost

€3.0 million grant (EIC Pathfinder, 101187647) to support the development of brain-spine

interface technology to restore hand and arm function after subcortical stroke. The five-

year project commenced on March 1st, 2025, and will end on February 1st, 2030. ONWARD

is joined by its EU-based research partners Commissariat à L’énergie Atomique et aux

Énergies Alternatives (CEA) and Dessintey of France, and Department of Clinical Sciences,

KI DS, Karolinska Institutet, of Sweden.

267

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

The Swiss State Secretariat for Education, Research, and Innovation (SERI) has provided

an additional €3.0 million to support Swiss-based activities and the Swiss partners École

Polytechnique Fédérale de Lausanne (EPFL), Centre Hospitalie Universitaire Vaudois (CHUV)

and University of Lausanne (UNIL) of Switzerland. ONWARD is receiving

€1.8 million from

EISMEA and SERI to develop the capability to program and simultaneously control two

investigational ARC

IPGs (implanted neurostimulators), and to further develop its ARC

Lead

for the cervical spinal cord, the spinal cord region responsible for upper extremity function.

2.2 Research & Development Expenses

Accounting policy:

Research costs are expensed as incurred. Development expenditure on

an individual project are recognized as an intangible asset when the Group can demonstrate:

•

The technical feasibility of completing the intangible asset so that it will be available for

use or sale

•

Its intention to complete and its ability to use or sell the asset

•

How the asset will generate future economic benefits

•

The availability of resources to complete the asset

•

The ability to measure reliably the expenditure during development

•

The ability to use the intangible asset generated

	2025	2024
Staff expenses	7,915	9,260
Operating expenses	4,403	4,623
	12,318	13,883

The Company’s research and development expenses consist primarily of costs incurred in the

design and development of its technology platforms, including expenses related to external

suppliers and third-party contractors, as well as employee-related expenses such as salaries,

benefits and share-based compensation. In addition, R&D expenses include costs associated

with securing and maintaining the Company’s intellectual property portfolio, including patent

and related expenses that directly support its development activities.

Research and development expenses decreased during the year as a result of lower external

service costs and reduced employee-related expenses. The decrease is primarily driven by

lower external development costs and a reduction in employee-related expenses, reflecting

the timing and scale of development activities during the year.

In the current year, the Group has reassessed the assumptions and disclosures related to

significant estimates and aligned these with the nature of its current activities and financial

reporting. Significant estimates relating to R&D expenses are no longer considered relevant

and have been removed.

2.3 Clinical & Regulatory Expenses

	2025	2024
Staff expenses	3,124	3,011
Operating expenses	2,606	1,743
	5,730	4,754

The Company’s clinical and regulatory expenses consist of the employee-related expenses

including salaries and benefits for employees working on clinical trials. In 2025, clinical

expenses were primarily driven by activities supporting the FDA submission for ARC

Home

Use clearance, regulatory efforts related to obtaining the CE mark in Europe, and continued

preparations for the pivotal Empower BP study.

269

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

2.4 Marketing & Market Access Expenses

	2025	2024
Staff expenses	5,848	2,101
Operating expenses	2,270	1,249
	8,118	3,350

The Company’s marketing and market access expenses primarily reflects the investments

in personnel to establish the commercial infrastructure required to support ARC

commercialization across the United States, Europe, and other international markets.

2.5 Quality Assurance Expenses

	2025	2024
Staff expenses	1,958	1,693
Operating expenses	404	323
	2,362	2,016

Quality assurance expenses consist primarily of quality control and quality assurance

expenses. These expenses include employee expenses, including salary benefits for

personnel, consulting, testing, and travel expenses. During 2025, efforts were primarily

focused on supporting regulatory submissions, including FDA clearance for ARC

home

use, CE mark activities in Europe, and broader quality oversight as the Company continues

to scale its operations.

2.6 General & Administrative Expenses

	2025	2024
Staff expenses	7,795	7,249
Depreciation and amortization	1,447	898
Other operating expenses	7,521	4,429
	16,763	12,576

The Company’s general and administrative expenses consist of employee expenses, including

salary and benefits for personnel and contractors in executive, finance, accounting, tax, and

human resources, as well as operating expenses relating to audit, legal, and supply chain.

General and administrative expenses increased in 2025 as the Company continued to scale

its operating (ARC

manufacturing set-up) and governance infrastructure (order to receipt

process) to support commercial activities. The increase primarily reflects higher personnel

costs, expanded corporate support functions, professional services related to strategic

financing and governance, and a modest increase in Board-related costs.

2.7 Employee Benefit Expenses

Accounting policy:

Short-term employee benefits

Short-term employee benefits include salaries and social security contributions, social

taxes, paid vacation, and bonuses. They are recognized as expenses for the period in which

employees perform the corresponding services. Outstanding payments at the end of the

period are shown as other current liabilities.

Post-employment benefits

Group companies operate various pension schemes. The schemes are funded through

payments to insurance companies or trustee-administered funds, determined by periodic

actuarial calculations. The Group has both defined benefit and defined contribution plans.

Defined contribution plan

A defined contribution plan is a pension plan under which the Group pays fixed contributions

into a separate entity. The Group has no legal or constructive obligations to pay further

contributions if the fund does not hold sufficient assets to pay all benefits to employees

relating to employee services in the current and prior periods. For defined contribution plans,

the Group pays contributions to publicly or privately administered pension insurance plans on

a mandatory, contractual, or voluntary basis. The Group has no further payment obligations

271

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

once the contributions have been paid. The contributions are recognized as personnel

expenses in the consolidated income statement when due.

All related expenses are recognized in the consolidated statement of profit and loss.

Contributions payable or prepaid contributions as at year-end are recognized under accruals

and deferred income, and prepayments and accrued income, respectively.

Defined benefit plan

The Group operates a defined benefit pension plan in Switzerland, which requires contributions

to be made to a separately administered fund. The cost of providing benefits under the defined

benefit plan is determined using the projected unit credit method.

Remeasurements, comprising of actuarial gains and losses are recognized in the statement

of financial position with a corresponding debit or credit to retained earnings through OCI

in the period in which they occur. Remeasurements are not reclassified to profit or loss in

subsequent periods.

Past service costs are recognized in profit or loss on the earlier of:

•

The date of the plan amendment or curtailment, and

•

The date that the Group recognizes related restructuring costs

Net interest is calculated by applying the discount rate to the net defined benefit liability or

asset. The Group recognizes the changes in the net defined benefit obligation due to service

costs comprising current service costs, past-service costs, gains and losses on curtailments

and non-routine settlements as part of operating expenses, and the net interest expense or

income as part of net finance costs in the consolidated statement of profit and loss.

Significant estimate:

The cost of the defined benefit pension plan and the present value

of the pension obligation are determined using actuarial valuations. An actuarial valuation

involves making various assumptions that may differ from actual developments in the future.

These include the determination of the discount rate, future salary increases, mortality rates,

and future pension increases. Due to the complexities involved in the valuation and its long-

term nature, a defined benefit obligation is sensitive to changes in these assumptions. All

assumptions are reviewed at each reporting date.

	2025	2024
Wages and salaries	20,423	17,330
Social security costs	2,026	1,507
Pension costs – defined benefit plan	779	771
Pension costs – other	81	64
Share-based benefit expenses	2,639	2,720
Other labor costs	692	923
	26,640	23,315

The increase in wages and salaries is driven by the composition of new hires versus leavers.

This shift in expertise aligns with the Company’s strategic goals. As at 31 December 2025, the

Group employed 137.3 full-time equivalents, including white-collar employees and contractors.

The following table presents a breakdown of the Company’s full-time equivalents as of 31

December 2025 and 2024:

	2025	2024
Research & Development	41.0	40.0
Clinical & Regulatory	19.8	14.0
Marketing & Market Access	31.9	14.0
Quality Assurance	11.8	8.6
General & Administrative	32.8	26.0
	137.3	102.6

As at 31 December 2025, the Company had 17.4 full-time equivalents employed by its Dutch

entity (2024: 12.4), 91.9 full-time equivalents employed by its Swiss entity (2024: 76.15), and

28 full-time equivalents employed by its U.S. entity (2024: 14).

273

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

2.8 Share-Based Payments

Accounting policy:

Employees (including senior executives) of the Group receive remuneration

in the form of share-based payments, whereby employees render services as consideration

for equity instruments (equity-settled transactions).

Equity-settled transactions

The cost of equity-settled transactions is determined by the fair value at the date when the

grant is made using an appropriate valuation model.

That cost is recognized, together with a corresponding increase in other reserves in equity,

over the period in which the performance and/or service conditions are fulfilled in employee

benefits expense. The cumulative expense recognized for equity-settled transactions at each

reporting date until the vesting date reflects the extent to which the vesting period has expired

and the Group’s best estimate of the number of equity instruments that will ultimately vest.

The statement of profit or loss expense or credit for a period represents the movement in

cumulative expense recognized as at the beginning and end of that period and is recognized

in operating expenses.

No expense is recognized for awards that do not ultimately vest, except for equity-settled

transactions for which vesting is conditional upon a market or non-vesting condition. These

are treated as vesting irrespective of whether or not the market or non-vesting condition is

satisfied, provided that all other performance and/or service conditions are satisfied.

When the terms of an equity-settled award are modified, the minimum expense recognized is

the expense had the terms not been modified, if the original terms of the award are met. An

additional expense is recognized for any modification that increases the total fair value of the

share-based payment transaction or is otherwise beneficial to the employee as measured

at the date of modification.

Significant estimate:

The Group measures the cost of equity-settled transactions with

employees by reference to the fair value of the equity instruments at the date at which they are

granted. Estimating fair value for share-based payment transactions requires determination

of the most appropriate valuation model, which is dependent on the terms and conditions

of the grant.

Long-term incentive plan (LTIP)

The LTIP plan is aimed at aligning the employee’s interest with the interests of the Shareholders

and to allow the employee to participate in the long-term growth of the Company. The LTIP is an

omnibus plan with the flexibility to issue different types of equity incentives. ONWARD awarded

options over its Ordinary Shares to participants (referred to as the “Award” or “Grant’) on the

Grant Dates as specified in the table below. Each option represents the right to receive one

Ordinary Share of ONWARD against payment of the exercise price. The options expire 10 years

after the Grant Date and become exercisable on vesting. The Grant is subject to continued

provision of services to the Company under a graded vesting schedule, with 25% of the Grant

vesting on the first anniversary of the Grant Date, and the remaining 75% of the Grant vesting

in equal, monthly tranches over the three years following the first anniversary of the Grant Date

(i.e., 2.083% per month). The number of options that will vest and become unconditional is only

subject to a continued service condition. All options granted have the same conditions. Options

do not settle automatically and are exercised at the option of the participant.

275

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025


			Number
Financial	Grant	Type of	of Options	Exercise	Expiration	Fair
Year	Date	Security	Granted	Price	Date	Value
2021	15/12/2021	Stock	612,000	EUR 9.70	15/12/2031	EUR 4.89
		Options
2022	1/4/2022	Stock	169,800	EUR 7.64	1/4/2032	EUR4.18
		Options
2022	26/9/2022	Stock	166,350	EUR 5.70	26/9/2032	EUR 3.19
		Options
2023	3/1/2023	Stock	978,050	EUR 6.12	3/1/2033	EUR 3.37
		Options
2023	28/2/2023	Stock	132,000	EUR 4.95	28/2/2033	EUR 2.73
		Options
2023	3/7/2023	Stock	308,175	EUR 5.18	3/7/2033	EUR 2.85
		Options
2024	15/1/2024	Stock	710,975	EUR 2.94	15/1/2034	EUR 1.60
		Options
2024	1/7/2024	Stock	460,688	EUR 5.08	1/7/2034	EUR 2.85
		Options
2024	5/12/2024	Stock	704,625	EUR 4.77	4/12/2034	EUR 2.68
		Options
2025	1/5/2025	Stock	100,000	EUR 4.19	1/5/2035	EUR 2.37
		Options
2025	1/7/2025	Stock	632,487	EUR 4.49	1/7/2035	EUR 2.53
		Options
2025	12/8/2025	Stock	32,000	EUR 4.11	12/8/2035	EUR 2.34
		Options

This fair value per option has been applied to the options granted for the recognition of the

share-based payment expense recognized:


	2025	2024
Share-based payment expense	2,639	2,720
	2,639	2,720

The table below summarizes the number and weighted average exercise prices (WAEP) of,

and movements in, share options during the year:


	2025	2025	2024	2024
	Number	WAEP	Number	WAEP
Outstanding at 1 January	3,553,606	EUR 5.43	1,828,650	EUR 6.85
Granted during the year	764,487	EUR 4.43	1,876,288	EUR 4.15
Forfeited during the year	(679,762)	EUR 5.65	(151,332)	EUR 6.65
Exercised during the year	(79,694)	EUR 4.23	–	–
Outstanding at 31 December	3,558,637	EUR 5.20	3,553,606	EUR 5.43


	Number	WAEP
Exercisable at 31 December 2025	1,588,520	EUR 6.00
Exercisable at 31 December 2024	950,137	EUR 7.22

The weighted average remaining contractual life for the share options outstanding at 31

December 2025 was 8.11 years (2024: 8.69 years).

The weighted average fair value of options granted during the year was EUR 2.50 (2024: EUR 2.31).

The range of exercise prices for options outstanding at the end of the year was EUR 2.94 to

EUR 9.70 (2024: EUR 2.94 to EUR 9.70).

The fair value of the awarded options was determined by applying a Binomial Option Pricing

Model that allows for exercising the option before the end of the option’s life.

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

277

As the options cannot be exercised between the Grant Date and the vesting date, the Hull-

White binomial formula, commonly used to value American options, was used. With the Hull-

White model the impact of a certain time-based event – such as a vesting period, or an early

exercise – can be taken into account.

Due to the different vesting dates for the different tranches in the option, we have calculated

the unique option values per tranche according to each vesting date. The total option value

per employee is then derived using a weighted average overall calculated option value for

each vesting date.

The following parameters were used in the option model for the calculation of the fair value

of the options as per each grant date:

	2025– 08	2025–0 7	2025–05	2024– 12	2024–0 7	2024–01
Fair value on date of
measurement (EUR)	2.34	2.53	2.37	2.68	2.85	1.60
Share price (EUR)	4.11	4.49	4.19	4.77	5.08	2.94
Exercise price (EUR)	4.11	4.49	4.19	4.77	5.08	2.94
Expected volatility	60.3%	59.5%	59.8%	61.4%	59.1%	57.0%
Term of the option	4 a	4 a	4 a	4 a	4 a	4 a
Expected dividend	–	–	–	–	–	–
Risk-free interest rate	2.7%	2.6%	2.4%	2.1%	2.6%	2.23%
Time to expiration	10	10	10	10	10	10

a: Vesting period is 1 – 4 years and depends on the vesting date of the specific tranche.

2.9 Income Tax

Accounting policy:

Current income tax

Current income tax assets and liabilities for the current period are measured at the amount

expected to be recovered from or paid to the taxation authorities. The tax rates and tax laws

used to compute the amount are those that are enacted or substantively enacted, at the

reporting date in the countries where the Group operates and generates taxable income.

Current income tax relating to items recognized directly in equity is recognized in equity and

not in the statement of profit or loss. Management periodically evaluates positions taken in

the tax returns with respect to situations in which applicable tax regulations are subject to

interpretation and establishes provisions where appropriate.

Deferred tax

Deferred tax is provided using the liability method on temporary differences between the tax

basis of assets and liabilities and their carrying amounts for financial reporting purposes at

the reporting date.

Deferred tax liabilities are recognized for all taxable temporary differences, except:

•

When the deferred tax liability arises from the initial recognition of goodwill or an asset

or liability in a transaction that is not a business combination and, at the time of the

transaction, affects neither the accounting profit nor taxable profit or loss

•

In respect of taxable temporary differences associated with investments in subsidiaries,

associates and interests in joint arrangements, when the timing of the reversal of the

temporary differences can be controlled and it is probable that the temporary differences

will not reverse in the foreseeable future

Deferred tax assets are recognized for all deductible temporary differences, the carry forward

of unused tax credits and any unused tax losses. Deferred tax assets are recognized to the

extent that it is probable that taxable profit will be available against which the deductible

279

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

temporary differences and the carry forward of unused tax credits and unused tax losses

can be utilized, except:

•

When the deferred tax asset relating to the deductible temporary difference arises

from the initial recognition of an asset or liability in a transaction that is not a business

combination and, at the time of the transaction, affects neither the accounting profit nor

taxable profit or loss

•

In respect of deductible temporary differences associated with investments in subsidiaries,

associates and interests in joint ventures, deferred tax assets are recognized only to the

extent that it is probable that the temporary differences will reverse in the foreseeable

future and taxable profit will be available against which the temporary differences can

be utilized

The carrying amount of deferred tax assets is reviewed at each reporting date and reduced

to the extent that it is no longer probable that sufficient taxable profit will be available to

allow all or part of the deferred tax asset to be utilized. Unrecognized deferred tax assets

are reassessed at each reporting date and are recognized to the extent that it has become

probable that future taxable profits will allow the deferred tax asset to be recovered.

Deferred tax assets and liabilities are measured at the tax rates that are expected to apply

in the year when the asset is realized or the liability is settled, based on tax rates (and tax

laws) that have been enacted or substantively enacted at the reporting date.

Significant estimate:

The Group has losses before tax which arose in the Netherlands that are

available to offset against future profits of the Dutch entity in which the loss arose. However,

these losses may not be used to offset taxable income elsewhere in the Group. The Group

evaluated and judged that at this moment it is not sufficiently likely that future profits will be

generated in the Dutch entity that can offset a deferred tax asset.

All Switzerland operations have a cost-plus agreement. The taxable amounts are settled.

There are no NOL

’s. Last fiscal year settled is 2022. Due to expected profits based on the cost-

plus the Swiss deferred tax assets relating to temporary differences have been recognized.

NOL

’s in the US entity prior to 2018 can be carried forward for 20 years. NOL

’s after 2018

can be carried forward indefinitely, limited to 80% of taxable income. On the acquisition of

ONWARD Medical Inc. (formerly known as NeuroRecovery Technologies Inc) a deferred tax

liability was recognized for the intangible asset (in-process R&D) identified in the PPA and

on the capitalized license fee. The Company recognized a deferred tax asset in the US entity

that offsets the deferred tax liability as allowed under IAS 12, with no impact on previously

reported results.

	2025	2024
Current income tax	(241)	(294)
Adjustments of current income tax of previous year	5	(45)
Deferred income tax	(75)	379
Total corporate income tax in profit and loss	(311)	40
Current income Tax charge at tax rate of 25.8%	10,674	9,227
Tax rate differences in foreign jurisdictions	(219)	(156)
Adjustments of current income tax of previous year	(5)	(45)
Non-deductible expenses	(567)	(553)
Net operating losses and temporary differences not recognized	(10,956)	(8,960)
Impact of FDII deduction	43	–
Recognition of previous non recognized deferred tax assets	744	575
Other	(25)	(48)
	(311)	40

The effective tax rate was 0.1% in 2025 (2024: 0.4%), which is lower than the statutory income

tax rate of 25.8% (2024: 25.8%) in the Netherlands. The difference is primarily due to the net

operating losses and temporary differences for which no deferred tax asset can be recognized.

The uncertainty is based on insufficient evidence of future sources of income to support the

realization of a deferred tax asset due to the Company being loss-making with limited tax

planning opportunities. As the Group has entered its commercial phase, it will continue to

review its transfer pricing framework to ensure it remains appropriate and aligned with the

Group’s evolving operations.

281

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Recognized deferred tax assets and liabilities

2025	Assets	Liabilities	Net
Intangible assets, including Goodwill	–	(1,485)	(1,485)
Right of use assets	–	(77)	(77)
Lease liability	84	–	84
Post-employment benefits	653	–	653
Losses available for offset against future	1,137	–	1,137
Taxable income
Set-off of deferred tax	(1,215)	1,215	–
Net deferred tax asset / (liability)	659	(347)	312

2024	Assets	Liabilities	Net
Intangible assets, including Goodwill	–	(1,786)	(1,786)
Right of use assets	–	(148)	(148)
Lease liability	156	–	156
Post-employment benefits	560	–	560
Losses available for offset against future		–	–
Taxable income	1,483	–	1,483
Set-off of deferred tax	(1,631)	1,631	–
Net deferred tax asset / (liability)	568	(303)	265

	2025	2024
Opening balance at January 1	265	(321)
Recognized in profit & loss	(75)	379
Remeasurement (gain)/loss on actuarial gains and losses in OCI	80	255
Foreign currency translation difference	42	(48)
Net deferred tax asset /(liability) at December 31	312	265

Of the estimated amount of tax losses carried forward and available as at 31 December 2025,

a deferred tax asset of EUR 1,137k has been recognized to offset the reversal of temporary

differences in the US. For the remaining unused operating losses in the Netherlands of

EUR 211M (2024: EUR 148M) and in the US of EUR 20M (2024: EUR 27M) no deferred tax is

recognized. These losses can be carried forward indefinitely subject to local tax rules, except

for approximately EUR 3M of losses in the US, which can be carried forward for 20 years

(ultimately by 2037).

No deferred tax liability has been recorded for the Swiss subsidiary due to the applicable tax

treaty between Switzerland and the Netherlands, which eliminates potential tax consequences

on undistributed earnings. Similarly, no deferred tax liability has been recognized for the U.S.

subsidiary, as it has negative retained earnings, and there are no undistributed profits that

could result in taxable temporary differences.

The Company offsets tax assets and liabilities if it has a legally enforceable right to set off

current tax assets and current tax liabilities, and the deferred tax assets and deferred tax

liabilities relate to income taxes levied by the same tax authority.

283

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

3. Non-Current Asset & Working Capital

3.0 Intangible Assets

	2025	2024
Goodwill	1,738	1,962
In-process R&D	–	6,059
Capitalised development costs	5,008	–
License fees	1,987	2,404
Net book value at 31 December	8,733	10,425

Goodwill

Accounting policy:

Goodwill is initially measured at cost, being the excess of the aggregate of

the consideration transferred and the amount recognized for non-controlling interests, and any

previous interest held, over the net identifiable assets acquired and liabilities assumed. If the

fair value of the net assets acquired is in excess of the aggregate consideration transferred,

the Group reassesses whether it has correctly identified all of the assets acquired and all

of the liabilities assumed, and reviews the procedures used to measure the amounts to be

recognized at the acquisition date. If the reassessment still results in an excess of the fair

value of net assets acquired over the aggregate consideration transferred, then the gain is

recognized in profit or loss.

After initial recognition, Goodwill is measured at cost less any accumulated impairment

losses. For the purpose of impairment testing, Goodwill acquired in a business combination

is, from the acquisition date, allocated to each of the Group’s cash-generating units that are

expected to benefit from the combination, irrespective of whether other assets or liabilities

of the acquiree are assigned to those units.

Where Goodwill has been allocated to a cash-generating unit and part of the operation within

that unit is disposed of, the goodwill associated with the disposed operation is included in

the carrying amount of the operation when determining the gain or loss on disposal. Goodwill

disposed in these circumstances is measured based on the relative values of the disposed

operation and the portion of the cash-generating unit retained.

	2025	2024
Cost	1,962	1,845
Accumulated changes	–	–
Net book value at 1 January	1,962	1,845
Additions
Foreign currency translation difference	(224)	117
Impairments	–	–
Net change	(224)	117
Cost	1,738	1,962
Accumulated changes	–	–
Net book value at 31 December	1,738	1,962

Capitalised development costs / In-process R&D

Accounting policy:

The cost of in-process R&D acquired in a business combination is the fair

value at the date of acquisition. Following regulatory clearance and the commencement of

commercialization activities, in-process R&D is reclassified to capitalized development costs.

Following initial recognition of the development expenditure as an asset (capitalized

development costs), the asset is carried at cost less any accumulated amortization and

accumulated impairment losses. Amortization of the asset begins when development is

complete and the asset is available for use. It is amortized over the period of expected future

benefit. Amortization is calculated on a straight-line basis over the estimated useful lives of

the In-process R&D of 15 years. Amortization is recorded in operating expenses. During the

period of development, the asset is tested for impairment annually.

Notes to the Consolidated Financial Statements

	Capitalised	In-process
	Development cost	R&D
Cost	–	5,850
Accumulated changes	–	(152)
Net book value at 1 January 2024	–	5,698
Foreign currency translation difference	–	361
Net change	–	361
Cost	–	6,211
Accumulated changes	–	(152)
Net book value at 31 December 2024	–	6,059
Reclassification to Capitalized development costs	6,059	(6,059)
Foreign currency translation difference	(692)	-
Amortization for the year	(359)	-
Net change	5,008	(6,059)
Cost	5,519	–
Accumulated changes	(511)	–
Net book value at 31 December 2025	5,008	–

During 2025, intangible assets previously described as in-process research and

development became available for use following regulatory clearance and the

commencement of commercialization activities. Accordingly, amortization of these

assets commenced during the year. These assets are presented within intangible assets

as capitalized development costs.

License Fees

Accounting policy:

License fees for the exclusive right to certain patents, critical in the

development of the ARC Therapies, are capitalized and measured at cost on initial recognition.

Following initial recognition of the license fees as an asset, the asset is carried at cost less any

accumulated amortization and accumulated impairment losses. Amortization of the asset

begins when development is complete and the asset is available for use. It is amortized over

the period of expected future benefit. Amortization is calculated on a straight-line basis over

the estimated useful lives of the license fee of 15 years. Amortization is recorded in operating

expenses. During the period of development, the asset is tested for impairment annually.

	2025	2024
Cost	2,404	2,261
Accumulated changes	–	–
Net book value at 1 January	2,404	2,261
Additions	–	–
Foreign currency translation difference	(275)	143
Reversals	–	–
Amortization for the year	(142)	–
Impairments	–	–
Net change	(417)	143
Cost	2,129	2,404
Accumulated changes	( 142 )	–
Net book value at 31 December	1,987	2,404

During 2025, the licensed technology became available for use following regulatory clearance

and the commencement of commercialization activities. Accordingly, amortisation of the

related intangible assets commenced in the year.

Impairment Assessment

The in-process research and development (“IPR&D”) was acquired through the acquisition of

GTX Medical SA (now ONWARD Medical SA) and the business combination with NRT Inc. (now

ONWARD Medical Inc.). The value of the IPR&D is dependent on the successful development

and regulatory approval of the Group’s neurostimulation technologies across its platforms.

As part of the NRT acquisition, ONWARD also assumed exclusive license agreements with

the Regents of the University of California (“UCLA”) and the California Institute of Technology

(“Caltech”). Pursuant to these agreements, the occurrence of the IPO triggered change-of-

control provisions resulting in additional payments, as well as ongoing annual license fees.

These payments are recognised as a separate class of intangible assets.

ONWARD

Medical Annual Report 2025

285

287

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

In accordance with the Group’s accounting policies, goodwill, IPR&D and license-related

intangible assets are subject to impairment review at least annually, or more frequently if

indicators of impairment arise.

As of 31 December 2025, management performed its annual impairment assessment in

accordance with IAS 36 by evaluating whether any indicators of impairment were present. This

assessment considered both external and internal factors, including the Group’s progress into

the commercial phase, regulatory approvals obtained, and the Group’s market capitalisation.

At year-end, the Group’s market capitalisation significantly exceeded the carrying value of

its goodwill and intangible assets.

The Group continues to operate as a single cash-generating unit (“CGU”), reflecting the

high degree of integration across its technology platforms, development activities, and

commercialisation efforts. While revenue streams and regulatory pathways may differ across

platforms, substantial operational and financial interdependencies remain, supporting the

assessment of a single CGU.

Based on this assessment, management concluded that the recoverable amount of the CGU

exceeded its carrying amount as of 31 December 2025. Accordingly, no impairment charge was

recognised during the year. As the recoverable amount was supported by observable market

evidence, the impairment assessment did not involve significant estimation uncertainty.

3.1 Property, Plant & Equipment

Accounting policy:

Property, plant, and equipment is stated at cost, net of accumulated

depreciation and accumulated impairment losses, if any. Such costs includes the cost

of replacing part of the property, plant, and equipment and borrowing costs for long-term

construction projects if the recognition criteria are met. When significant parts of property,

plant and equipment are required to be replaced at intervals, the Group recognizes such parts

as individual assets with specific useful lives and depreciates them accordingly. Likewise,

when a major inspection is performed, its cost is recognized in the carrying amount of the

plant and equipment as a replacement if the recognition criteria are satisfied. All other repair

and maintenance costs are recognized in profit or loss as incurred.

Depreciation is calculated on a straight-line basis over the estimated useful lives of the assets

as follows:

•

Office equipment

3 years

•

Demonstration / evaluation equipment

3 years

•

Leasehold improvements

5 years

The useful life of leasehold improvements is the same or less than the lease term.

An item of property, plant, and equipment and any significant part initially recognized is

derecognized upon disposal or when no future economic benefits are expected from its use or

disposal. Any gain or loss arising from derecognition of the asset (calculated as the difference

between the net disposal proceeds and the carrying amount of the asset) is included in the

income statement when the asset is derecognized.

The residual values, useful lives, and methods of depreciation of property, plant, and equipment

are reviewed at each financial year end and adjusted prospectively, if appropriate.

Cost

			Demo /
	Office	Leasehold	Evaluation
	Equipment	Improvements	Devices	Total
At 1 January 2024	1,275	335	–	1,610
Additions	153	–	–	153
Foreign currency translation difference	39	14	–	53
At 31 December 2024	1,467	349	0	1,816
Additions	264	–	168	432
Disposals	–	–	–	–
Foreign currency translation difference	(1)	–	–	(1)
At 31 December 2025	1,730	349	168	2,247

289

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Accumulated Depreciation

			Demo /
	Office	Leasehold	Evaluation	Total
	Equipment	Improvements	Devices
At January 1, 2024	(888)	(113)	–	(1001)
Depreciation for the year	(214)	(129)	–	(343)
At December 31, 2024	(1,102)	(242)	0	(1,344)
Depreciation for the year	(240)	(106)	(22)	(369)
At December 31, 2025	(1,342)	(349)	(22)	(1,713)

Net book value

			Demo /
	Office	Leasehold	Evaluation	Total
	Equipment	Improvements	Devices
At December 31, 2024	365	106	0	471
At December 31, 2025	388	0	146	534

3.2 Right of Use Assets & Lease Liabilities

Accounting policy:

The Group assesses at contract inception whether a contract is, or

contains, a lease. That is, if the contract conveys the right to control the use of an identified

asset for a period of time in exchange for consideration.

Group as a lessee

The Group applies a single recognition and measurement approach for all leases,

except for short-term leases and leases of low-value assets. The Group recognizes lease

liabilities to make lease payments and right-of-use assets representing the right to use

the underlying assets.

Right-of-use assets

The Group recognizes right-of-use assets at the commencement date of the lease (i.e., the

date the underlying asset is available for use). Right-of-use assets are measured at cost,

less any accumulated depreciation and accumulated impairment losses, and adjusted for

any remeasurement of lease liabilities. The cost of right-of-use assets includes the initial

measurement amount of lease liabilities recognized, initial direct costs incurred, and lease

payments made at or before the commencement date, less any lease incentives received.

Right-of-use assets are depreciated on a straight-line basis over the shorter of the lease term

and the estimated useful lives of the assets.

If ownership of the leased asset transfers to the Group at the end of the lease term or the cost

reflects the exercise of a purchase option, depreciation is calculated using the estimated

useful life of the asset.

Lease Liabilities

At the commencement date of the lease, the Group recognizes lease liabilities measured at

the present value of lease payments to be made over the lease term. The lease payments

include fixed payments (including in-substance fixed payments) less any lease incentives

receivable, variable lease payments that depend on an index or a rate, and amounts expected

to be paid under residual value guarantees. The lease payments also include the exercise

price of a purchase option reasonably certain to be exercised by the Group and payments of

penalties for terminating the lease, if the lease term reflects the Group exercising the option

to terminate.

Variable lease payments that do not depend on an index or a rate are recognized as expenses

(unless they are incurred to produce inventories) in the period in which the event or condition

that triggers the payment occurs.

In calculating the present value of lease payments, the Group uses its incremental borrowing

rate at the lease commencement date because the interest rate implicit in the lease is

not readily determinable. After the commencement date, the amount of lease liabilities is

increased to reflect the accretion of interest and reduced for the lease payments made. In

291

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

addition, the carrying amount of lease liabilities is remeasured if there is a modification, a

change in the lease term, a change in the lease payments (e.g., changes to future payments

resulting from a change in an index or rate used to determine such lease payments), or a

change in the assessment of an option to purchase the underlying asset. The Group’s lease

liabilities are included in lease liabilities.

Short-term leases and leases of low-value assets

The Group applies the short-term lease recognition exemption to its short-term leases of office

space (i.e., those leases that have a lease term of 12 months or less from the commencement

date and do not contain a purchase option). It also applies the lease of low-value assets

recognition exemption to leases of office equipment that are considered to be low value. Lease

payments on short-term leases and leases of low-value assets are recognized as expense on

a straight-line basis over the lease term.

Right-of-use assets

The Group entered into a five-year lease for offices in Lausanne, Switzerland in November

2021. This lease is classified as a right-of-use asset. The office lease in Eindhoven was

extended in November 2025 for a period of one year (ending October 2026).

Key movements relating to right-of-use assets are presented below:

	2025	2024
Net book value at 1 January	1,054	1,483
Additions	69	82
Depreciation for the year	(579)	(560)
Foreign currency translation impact	7	49
Net book value at 31 December	551	1,054

The office buildings are leased for office space. Subsequent to 31 December 2025, the Group

agreed in principle to extend the Lausanne office lease. As no legally enforceable extension

option existed at year-end, the potential extension was not considered in the lease term and

therefore has not been reflected in the financial statements as of 31 December 2025. Refer

also to Note 5.3.

The lease in Eindhoven includes an extension option for an additional one year; the extension

was included in the calculation of the right-of-use asset recognized over a full period of

two years. The additions represent the annual increase in lease payments under the lease

contracts and the additional one year extension.

Lease liabilities

The maturity of the lease liability in relation to the office building is as follows:

	2025	2024
Less than one year	552	633
One to five years	54	527
More than five years	–	–
Total lease liability	606	1,160

Movement of the lease liability:

	2025	2024
Balance as at 1 January	1,115	1,619
Additions	69	82
Interest accretion	37	56
Repayments	(637)	(616)
Foreign currency impact	7	(26)
Total lease liability	591	1,115

The incremental borrowing rate applied is 4% for the Lausanne office and is 7.4% for the

Eindhoven office. The Group had total cash outflows for leases of €637k in 2025 (EUR 616k

in 2024).

For the maturity analysis of the undiscounted cash flows, refer to note 4.3.

293

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

3.3 Inventories

Accounting policy:

Inventories consist of raw materials, work-in-progress and finished goods

of the ARC

System. Inventories are valued at the lower of cost and net realizable value. Costs

incurred in bringing each product to its present location and condition are accounted for as

follows: cost of direct materials and labor and a proportion of manufacturing overheads based

on the normal operating capacity, excluding borrowing costs. The cost is assigned using the

FIFO (“first-in-first-out”) method. Net realizable value is the estimated selling price in the

ordinary course of business, less estimated costs of completion and the estimated costs

necessary to make the sale.


	2025	2024
Raw Materials	656	102
Work in progress	0	–
Finished goods	147	–
	803	102

As at 31 December 2025, the Group had inventory of Raw materials amounting to EUR 656k.

The increase in stock of raw materials is directly attributable to increase in commercial

operations during the year.

3.4 Indirect Tax Receivables

The tax receivables consist of refundable VAT amounting to EUR 381k (2024: EUR 125k) and

are collectable within 12 months. The increase in the receivable is a direct result of increase in

expenses during the year. The VAT returns are filed on a quarterly basis and claims received

throughout the year.

3.5 Trade Receivables


	2025	2024
Trade receivables	1,195	160
	1,195	160

Trade receivables represent amounts due from customers, are non-interest bearing, and are

generally due for settlement within 30 days in accordance with the agreed credit terms. The

balance is shown net of the allowance for expected credit losses of EUR 148k (2024:EUR -).

3.6 Other Current Assets


	2025	2024
Advance payments	1,941	2,137
Grants and other receivables	1,341	714
Rental guarantee	305	302
	3,587	3,153

The Group provided a guarantee of EUR 305k (2024: EUR 302k) to fulfil collateral requirements

relating to the Lausanne office rental agreement. This guarantee places no restriction on

the cash position and is payable on demand if the Company fails to meet its commitments.

Advance payments mostly relate to prepaid D&O insurance and advance paid to suppliers

for production and components. The increase in grants and other receivables is mainly due

to finalising the replacement funding agreement with SERI for the NEMO grant and addition

of the ReverseStroke grant, refer to Note 2.1.

3.7 Cash and Cash Equivalents

Accounting policy:

Cash and short-term deposits in the statement of financial position

comprise cash at banks and on hand, and short-term deposits with a maturity of three

months or less, that are readily convertible to a known amount of cash and subject to an

insignificant risk of change in value.

For the purpose of the consolidated statement of cash flows, cash and cash equivalents

consist of cash and short-term deposits as defined above, net of outstanding bank overdrafts,

as they are considered an integral part of the Group’s cash management.

295

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025


	2025	2024
Cash at bank	9,055	12,043
Short-term deposits	59,055	48,000
Cash and cash equivalents	68,110	60,043
Cash and cash equivalents	68,110	60,043

Cash at banks earns interest at floating rates based on daily bank deposit rates. Short-term

deposits are made for varying periods of between one day and three months, depending on

the immediate cash requirements of the Group, and earn interest at the respective short

term deposit rates.

As part of the loan agreement with Runway Growth Capital LLC, the Group has pledged

the majority of the bank and deposit accounts as collateral to secure its outstanding debt

obligations. This serves as security for compliance with the loan covenants outlined in the

agreement. In the event of a breach of these covenants, the lender may have the right to

enforce its security interest over these assets. Management actively monitors compliance

with all covenants to mitigate the risk of default.

As at 31 December 2025, there were no fixed term deposits for periods exceeding three months.

At 31 December 2025, the Group had no bank overdrafts. All cash is freely at the disposal of

the company.

3.8 Trade Payables

Trade payables and accrued expenses are non-interest bearing and are normally settled on

30-90 day terms. The increase in trade payables to EUR 3,083k (2024: EUR 1,269k) is mainly

because of large amounts payable due at the end of 2025 that were settled shortly after

financial year end.

3.9 Other Payables

The other payables can be broken down as follows:


	2025	2024
Wage tax and social security	484	144
Grants received in advance	995	441
Bonus	3,511	3,095
Invoices to be received	1,070	1,194
Other	818	555
Grant-related payables	–	1,359
	6,878	6,788

The decrease in Other Payables is due to repayment of grant amounts due to EISMEA

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

297

4. Financing, Financial Risk Management & Financial Instruments

4.0 Issued Capital & Reserves

Share Capital & Share Premium

Accounting policy:

Ordinary Shares are classified as

share capital

. Equity instruments are

recorded at the proceeds received, net of direct issue costs.

The

share premium

represents the amount by which the fair value of the consideration received

exceeds the nominal value of shares issued. Incremental costs directly attributable to the issue

of new shares or options are shown in equity as a deduction, net of tax, from the proceeds.

The authorized share capital (“maatschappelijk kapitaal”) amounts to EUR 18,000,000

(2024: EUR 18,000,000) divided into 75,000,000 (2024: 75,000,000) Ordinary Shares and

75,000,000 (2024: 75,000,000) Preferred Shares with a nominal value of EUR 0.12 each.

In October 2025, the Company raised EUR 50.8 million (gross proceeds) by way of an

accelerated bookbuild offering and a public offering in France. A total of 11,300,000 new

ordinary shares were issued at the price of EUR 4.50 per share. Transaction costs of EUR

3,24 million was recognised in Equity decreasing share premium.

At 31 December 2025, 56,008,257 Ordinary Shares were outstanding (31 December 2024:

44,628,834

shares). All of the issued Ordinary Shares are fully paid-up and represent capital

in the Company. No shareholders have any voting rights different from any other shareholder.

Other Reserves

	Currency	Stock
	Translation	Compensation	Total Other
	Differences	Reserve	Reserves
Balance at 1 January 2024	164	4,324	4,488
Share-based payment expense: LTIP	–	2,720	2,720
Reclassification of the fair value of forfeited options	–	(873)	(873)
Currency translation differences	434	–	434
Balance at 31 December 2024	599	6,171	6,770
Share-based payment expense: LTIP	–	2,639	2,639
Reclassification of the fair value of forfeited options	–	(1,565)	(1,565)
Currency translation differences	(1,045)	–	(1,045)
Balance at 31 December 2025	(446)	7,245	6,799

Currency translation reserve

Exchange gains and losses arising from the translation of the functional currency of foreign

operations to the reporting currency of the parent are accounted for in this legal reserve.

In the case of the sale of a participating interest, the associated accumulated translation

differences are transferred to the profit and loss account and presented therein as part of

the result on the sale.

The foreign currency translation reserve relates to the investment in United States.

Stock compensation reserve

The stock compensation reserve is used to recognize the value of equity-settled share-

based payments provided to employees, including key management personnel, as part of

their remuneration.

299

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

4.1 Earnings Per Share (EPS)

Accounting policy:

Basic EPS is calculated by dividing the profit for the year attributable

to ordinary equity holders of the parent by the weighted average number of Ordinary shares

outstanding during the year.

Diluted EPS is calculated by dividing the profit attributable to ordinary equity holders of the

parent (after adjusting for interest on the convertible Preference shares) by the weighted

average number of Ordinary shares outstanding during the year plus the weighted average

number of Ordinary shares that would be issued on conversion of all the dilutive potential

Ordinary shares into Ordinary shares.

The objective of determining diluted EPS is to reflect the maximum possible dilutive

effect arising from potential Ordinary shares outstanding during the period. The Group is

currently loss-making and there are currently no anti-dilutive potential Ordinary shares to

be considered. Therefore, diluted EPS is disregarded for 2025. The share options granted

under the LTIP (refer to Note 2.9) could have a potential dilutive effect in the future but had

no impact in 2025.

There have been no other transactions involving Ordinary shares or potential Ordinary shares

between the reporting date and the date of authorization of these financial statements.

The following tables reflect the income and share data used in the EPS calculation:

Profit (Loss) Attributable to Ordinary Shareholders

	2025	2024
Profit (loss) for the year, attributable to equity holders of the parent	(41,787)	(35,725)

Weighted-Average Number of Ordinary Shares

	2025	2024
	Thousands	Thousands
Weighted average number of ordinary shares for basic EPS	46,671	44,629

4.2 Financial Liabilities

Accounting policy:

Financial instruments – initial recognition and subsequent measurement

A financial instrument is any contract that gives rise to a financial asset of one entity and

a financial liability or equity instrument of another entity. Financial assets and financial

liabilities are initially recognized when the Company becomes a party to the contractual

provisions of the instrument.

Financial Liabilities

Financial liabilities are classified, at initial recognition, as financial liabilities at fair value

through profit or loss, loans and borrowings, payables, or as derivatives designated as hedging

instruments in an effective hedge, as appropriate. A financial liability is classified as FVPL

if it is classified as held-for-trading, it is a derivative or it is designated as such on initial

recognition. Financial liabilities at FVPL are measured at fair value and net gains and losses,

including any interest expense, are recognized in profit or loss. Other financial liabilities

are subsequently measured at amortized cost using the effective interest method. Interest

expense and foreign exchange gains and losses are recognized in profit or loss. Any gain or

loss on derecognition is also recognized in profit or loss

All financial liabilities are recognized initially at fair value and, in the case of liabilities at

amortized cost , net of directly attributable transaction costs.

The Group’s financial liabilities include trade payables, other payables, loans, and borrowings.

For purposes of subsequent measurement, financial liabilities are classified in two categories:

•

Financial liabilities at fair value through profit and loss

•

Financial liabilities at amortized cost

301

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Financial liabilities at fair value through profit or loss (FVPL)

Financial liabilities at fair value through profit or loss include financial liabilities held for

trading and financial liabilities designated upon initial recognition as at fair value through

profit or loss.

Financial liabilities are classified as held for trading if they are incurred for the purpose of

repurchasing in the near term. This category also includes derivative financial instruments

entered into by the Group that are not designated as hedging instruments in hedge

relationships as defined by IFRS 9. Separated embedded derivatives are also classified as

held for trading unless they are designated as effective hedging instruments.

Gains or losses on liabilities held for trading are recognized in the statement of profit or loss.

Financial liabilities designated upon initial recognition at fair value through profit or loss are

designated at the initial date of recognition, and only if the criteria in IFRS 9 are satisfied.

The Group has not designated any financial liability as at fair value through profit or loss.

Financial liabilities at amortized cost

This is the category most relevant to the Group. After initial recognition, interest-bearing loans

and borrowings are subsequently measured at amortized cost using the effective interest

rate (“EIR”) method. Gains and losses are recognized in the profit or loss when the liabilities

are derecognized, as well as through the EIR amortization process.

Amortized cost is calculated by taking into account any discount or premium on acquisition

and fees or costs that are an integral part of the EIR. The EIR amortization is included as

finance costs in the statement of profit or loss.

Derecognition

A financial liability is derecognized when the obligation under the liability is discharged or

cancelled or expires. When an existing financial liability is replaced by another from the same

lender on substantially different terms, or the terms of an existing liability are substantially

modified, such an exchange or modification is treated as the derecognition of the original

liability and the recognition of a new liability at fair value. The difference in the respective

carrying amounts is recognized in the statement of profit or loss.

Offsetting of financial instruments

Financial assets and financial liabilities are offset and the net amount is reported in the

consolidated statement of financial position if there is a currently enforceable legal right to

offset the recognized amounts and there is an intention to settle on a net basis, to realize the

assets and settle the liabilities simultaneously. No offsetting is currently applied.


	2025	2024
Current financial liabilities	370	437
Warrants issued to Runway Growth	370	437
Non-current financial liabilities	13,074	13,972
Innovation loan	–	–
Runway Growth loan	13,074	13,972
Total financial liabilities	13,444	14,409

Innovation loan

On 5 February 2016, the Group was granted a loan from RVO NL (Dutch Government) of EUR

10M payable according to a set payment scheme. The loan was advanced in installments

based on progress. This loan was repaid in 2024.


	2025	2024
Loan as per January 1	–	15,255
Loan amount received	–	–
Interest accrued during the year	–	767
Loan amount repaid during the year	–	(16,022)
Net book value at December 31	–	–

The loan carried interest at 10%.

303

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Runway Growth Loan

In 2024 the Company and its subsidiaries, ONWARD Medical, Inc. and ONWARD Medical

S.A., signed a loan agreement in the amount of up to EUR 52.5 million (the “Loan Agreement”)

with U.S.-based lender Runway Growth Capital LLC (the “Lender”). The loan was used to (i)

repay all of the Company’s outstanding debt, (ii) fund the Company’s upcoming commercial

and clinical activities, and (iii) support for working capital and general corporate purposes.

The facility comprises five separate credit tranches. An initial tranche of €16.0 million was

made available upon execution of the Loan Agreement and was drawn in full at that time.

Three additional committed tranches, consisting of €14.0 million, up to €5.0 million, and up

to €7.5 million, are available to the Company until 31 July 2026, subject to the achievement of

specified milestones and minimum quarterly revenue and EBITDA performance thresholds

as set out in the Loan Agreement. Compliance with the revenue and EBITDA performance

thresholds are tested as of the last day of each fiscal quarter and liquidity is tested monthly.

Failure to meet the applicable milestones or financial performance criteria would limit the

Company’s ability to draw further amounts under these tranches. Management monitors

compliance with these conditions on an ongoing basis as part of its liquidity planning. A fifth

tranche of up to €10.0 million is uncommitted and may be made available in the first quarter

of 2027 at the sole discretion of the lender.

Amounts drawn under the facility bear interest at a rate equal to the Term Secured Overnight

Financing Rate (SOFR) for a three-month interest period (currently 4.25% (2024: 6%), subject

to a floor of 4.25%), plus a margin of 6.50%. The obligations under the Loan Agreement are

secured by a security interest over substantially all of the assets of ONWARD Medical N.V.

and its subsidiaries.

As noted above, the loan documents provide for a number of affirmative and negative

covenants by the Company customary for financings of this type, most notably financial

covenants relating to revenue, earnings before interest taxes, depreciation and amortization

(EBITDA) and minimum liquidity targets. Revenue and EBITDA is measured quarterly and

liquidity monthly. In December 2024, an amendment was agreed upon stipulating that,

for 2025, compliance with aforementioned covenants would not be required, provided the

Company maintains the specified minimum cash-to-debt ratio monitored on a monthly basis.

This amendment was extended in December 2025 for a further 6 months, ending 30 June

2026, on the same basis.

As of the reporting date, the Company was in compliance with all covenants. Management

actively monitors covenant compliance to ensure ongoing adherence. The loan is classified

as non-current since earliest maturity date is 15 June 2027, provided that if the Extension

Milestone is satisfied, the maturity date shall automatically be extended to 15 June 2028.

Certain Intellectual Property (patents registered) have been pledged to Runway Growth in

case of default of repayment of the loan. These patents have not been capitalized as at 31

December 2025. The loan was revalued at the closing rate on 31 December 2025.


	2025	2024
Loan opening balance	13,972	–
Loan amount received	–	14,116
Transaction cost amortisation	467	212
Interest accrued during the period	1,655	944
Interest paid	(1,661)	(861)
Foreign currency translation difference	(1,359)	–
Warrants issued to Runway Growth	–	(439)
Closing balance	13,074	13,972

Warrants issued to Runway Growth

In connection with the debt financing entered into by the Company, the Company issued

warrants to the lender that entitle the lender to purchase ordinary shares in the capital of the

Company. The exercise price per share was determined based on the lowest 30-day volume

weighted average price (VWAP) observed between 9 April 2024 and the signing date of the

debt financing, resulting in an exercise price of €4.83 per share. The number of shares subject

to the warrants corresponds to five percent (5.00%) of the principal amount drawn under the

facility, calculated initially upon the first drawdown and subsequently upon each additional

305

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

loan advance, divided by the applicable exercise price. The warrants may be exercised either

through a cash exercise, whereby the warrant holder pays the aggregate exercise price in

cash to the Company, or on a cashless basis, in which case the Company issues a number

of shares determined by reference to the fair value of the warrants at the time of exercise.

The exercise period of the warrants is ten (10) years, commencing on the date immediately

following the expiry of a ninety (90) calendar day waiting period after the closing date of the

financing. As the warrants became exercisable ninety days after closing, the Company does

not have the unconditional right to defer settlement of the warrant liability for at least twelve

months after the reporting date. Accordingly, the lender warrants continue to be classified

as current liabilities.

	Issue	Type of	Number of	Exercise	Expiration
Financial Year	Date	Security	Warrants	Price	Date
2025	2/7/2024	Lender	165,631	EUR 4.83	2/7/2034
		Warrants

The fair value of the awarded options was determined by applying a Binomial Option Pricing

Model that allows for exercising of the Lender Warrants before the end of the exercise period.

The Hull-White binomial formula was used. With the Hull-White model the impact of a certain

time-based event – such as a vesting period, or an early exercise – can be taken into account.

The following parameters were used in the option model for the calculation of the fair value

of the warrants:


	31 Dec 2025	31 Dec 2024
Fair value on date of measurement (EUR)	2.24	2.64
Share price (EUR)	4.49	5.18
Exercise price (EUR)	4.83	4.83
Expected volatility	60.1%	61.2%
Vesting period in years	0.00	0.00
Expected dividend	–	–
Risk-free interest rate	2.8%	2.40%
Time to expiration	8.7	9.7


	2025	2024
Lender warrants issued	437	439
Fair value adjustment recognised in profit and loss	(67)	(2)
Closing balance	370	437

4.3 Financial Risk Management Objectives & Policies

The Group’s principal financial liabilities comprise of loans and borrowings and trade and

other payables. The main purpose of these financial liabilities is to finance the Group’s

operations and to provide guarantees to support its operations.

The Group is responsible for implementing and evaluating policies which govern the funding,

investments, and any use of derivative financial instruments. The Group is exposed to various

risks. The Group monitors risk exposure on an ongoing basis, as summarized below:

Capital management

Capital includes issued capital, share premium, and all other equity reserves attributable to

the equity holders of the parent. The primary objective of the Group’s capital management is

to continue as a going concern while maximizing shareholder value. The Group manages its

capital structure and will consider adjustments in light of changes in economic conditions. To

maintain or adjust the capital structure, the Group may issue new shares.

Liquidity risk

The Group manages liquidity risk by continuously monitoring forecast and actual cash flows.

The Group’s objective is to maintain a balance between continuity of funding and flexibility

through the use of subsidies and grants, and sufficient progress towards regulatory approval,

which is related to future financing rounds.

Cash is invested in low-risk investments such as short-term bank deposits or savings

accounts. The Group mainly makes use of liquid investment in current accounts (in Euros) or

short-term deposit accounts. The ability of the Group to maintain adequate cash reserves to

support its activities in the medium term is highly dependent on the Group’s ability to raise

additional funds.

The following table details the undiscounted remaining contractual maturity for the Group’s

financial liabilities with agreed repayment periods, including both interest and principal

cash flows:

As at 31 December 2025:

	Less than			More than
	1 Year	1-3 Years	3-5 Years	5 Years	Total
Runway Growth loan	1,587	1 0 , 289	7,872	–	19,748
Lease liability	552	54	–	–	606
Warrants issued to Runway Growth	370	–	–	–	370
Trade payable	3,083	–	–	–	3,083
Total	5,592	1 0 , 343	7,872	–	23,807

As at 31 December 2024:

	Less than			More than
	1 Year	1-3 Years	3-5 Years	5 Years	Total
Runway Growth loan	1,972	3,944	18,820	–	24,736
Lease liability	633	527	–	–	1,160
Warrants issued to Runway Growth	437	–	–	–	437
Trade payable	1,269	–	–	–	1,269
Total	4,311	4,471	18,820	–	27,602

Market risk

Market risk is the risk that the fair value of future cash flows of a financial instrument will

fluctuate because of changes in market prices. The Group’s activities may expose it to changes

in foreign currency exchange rates and interest rates. The Group is not exposed to any equity

price risk or commodity price risk, as it does not invest in these classes of investments.

Credit risk

With the start of initial commercial sales, the Group now records trade receivables. Given

the limited scale of activity to date, trade receivables are modest and credit risk is assessed

as low. Credit risk for the year continues to primarily relate to cash, cash equivalents, and

deposits held with banks and financial institutions. The Group places surplus funds only

with internationally reputable commercial banks and financial institutions. Short-term and

fixed-term deposits are entered into in accordance with internal approval policies. The Group

maintains banking relationships with ING, Belfius, UBS, First American Bank, Deutsche

Bank, Banque Cantonale Vaudoise (BCV) and JPMorgan Chase. The use of multiple financial

institutions is intended to limit concentration risk and mitigate potential losses arising from

a counterparty’s inability to meet its obligations.

Currency risk

The Group is exposed to currency risk for the activities in the US (accounting in US dollars)

and Switzerland (accounting in Swiss francs), whereas the functional currency of the Group

is the Euro. The risk is currently managed by replenishing the US and Swiss bank accounts at

regular intervals to account for both the positive and negative changes. The Company does

not hedge currently its operational FX risk and its risk on outstanding balances denominated

in another currency than its functional currency.

Currency risk sensitivity

The Company is exposed to foreign currency risk primarily from monetary assets and liabilities

denominated in currencies other than its functional currency. The most significant exposures

relate to the U.S. dollar (USD) and Swiss franc (CHF).

A 10% strengthening or weakening of the euro against these currencies at the reporting date

would have increased or decreased profit before tax by the amounts shown below, assuming

all other variables remain constant.

Currency	FX movement	Effect on profit before tax
USD	+10%	€0.2 million increase
USD	-10%	€0.2 million decrease
CHF	+10%	€0.3 million increase
CHF	-10%	€0.3 million decrease

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

307

Interest rate risk

Interest rate risk is the risk that the fair value or future cash flows of a financial instrument

will fluctuate because of changes in market interest rates. The Group’s exposure to the risk

of changes in market interest rates relates primarily to the Runway Growth long-term debt

obligation that bears interest at a rate equal to Term Secured Overnight Financing Rate

(SOFR) for a three-month interest period (2025: 4.25% (2024:6.00%), subject to a 4.25% floor),

plus a margin of 6.50%.

Interest rate sensitivity

The Company is exposed to interest rate risk primarily in relation to its interest-bearing cash

balances and variable-rate borrowings. Interest rate risk arises from the potential impact of

changes in market interest rates on the Company’s financial income and expense.

At 31 December 2025, the Company held interest-bearing cash and cash equivalents of €68.1

million and had outstanding interest-bearing borrowings of € 13.0 million. Assuming all other

variables remain constant, a reasonably possible change in market interest rates of 100 basis

points would have the following impact on profit before tax based on the net exposure at the

reporting date.

This sensitivity analysis reflects the effect of changes in interest rates on interest income and

interest expense for financial instruments held at the reporting date and assumes that the

change in interest rates had occurred at the beginning of the reporting period.

Interest rate movement	Effect on profit before tax
Increase of 100 basis points	€0.6 million increase
Decrease of 100 basis points	€0.6 million decrease

4.4 Fair Value & Fair Value Hierarchy of the Financial Statements

Accounting policy:

All assets and liabilities for which fair value is measured or disclosed in

the financial statements are categorized within the fair value hierarchy, described as follows,

based on the lowest level input that is significant to the fair value measurement as a whole:

•

Level 1 — Quoted (unadjusted) market prices in active markets for identical assets or liabilities

•

Level 2 — Valuation techniques for which the lowest level input that is significant to the

fair value measurement is directly or indirectly observable

•

Level 3 — Valuation techniques for which the lowest level input that is significant to the

fair value measurement is unobservable.

The carrying amounts and fair values of the Group’s financial instruments are as follows,

including its fair value hierarchy:

	Carrying	Estimated
2025	Amount	Fair Value
Financial liabilities
Runway Growth loan (Level 2)	13,074	14,6 84
Lender Warrants (Level 3)	370	370
Total financial liabilities	13,444	1 5,054

	Carrying	Estimated
2024	Amount	Fair Value
Financial liabilities
Runway Growth loan (Level 2)	13,972	16,818
Lender Warrants (Level 3)	437	437
Total financial liabilities	14,409	17,255

Management has assessed that the fair values of cash and cash equivalents, accounts

receivable and accounts payable approximate to their carrying amounts largely due to the

short-term maturities of these instruments.

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

309

311

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

The fair values of the financial assets and liabilities are included at the amount at which the

instrument could be exchanged in a current transaction between willing parties, other than

in a forced or liquidation sale. The following methods and assumptions were used to estimate

the fair values:

The fair value of the Runway Growth loan and due interest have been calculated by discounting

the expected future cash flows using rates currently available for instruments with similar

terms, credit risk and remaining maturities.

During the period, there were no transfers of fair value measurements between any levels

for either financial assets or financial liabilities. The Lender Warrants issued in 2024 are

considered to be level 3 in the fair value hierarchy.

The significant unobservable inputs used in the fair value measurement of the Lender

Warrants, categorized within level 3, together with a quantitative sensitivity analysis at 31

December 2025 is shown below. Any movement in the fair value of the Lender Warrants will

be recognized in profit and loss. Please refer to Note 4.2 for the detailed description of the

methodology applied for the fair value measurement of the Lender Warrants.

Please refer to Note 4.2 for the detailed description of the methodology applied for the fair

value measurement of the Lender Warrants

For the sensitivity analysis the exercise multiple is adjusted by steps of 0.2, and for the

volatility sensitivity we applied a range of 50.0% to 70.0%. The impact in profit and loss can

vary from a gain of EUR 44k to a loss of EUR 35k.

			Volatility
Exercise Multiple	50.0%	60.1%	70.0%
2.0	326	342	354
2.2	346	370*	390
2.4	362	383	405

*This is the fair value of the Lender Warrants as recognized at 31 December 2025.

4.5 Financial Income & Expense

Accounting policy:

Interest income is recognized by applying the effective interest rate,

except for short-term receivables when the effect of discounting is immaterial. The

Company’s financial assets include cash and cash equivalents and other long term and

current receivables.

Borrowing costs directly attributable to the acquisition, construction, or production of an

asset that necessarily takes a substantial period of time to get ready for its intended use or

sale are capitalized as part of the cost of the asset. All other borrowing costs are expensed

in the period in which they occur. Borrowing costs consist of interest and other costs that an

entity incurs in connection with the borrowing of funds.

	2025	2024
Interest income from deposits	580	791
Interest on loans	(2,122)	(1,923)
Interest on post-employment benefits	(31)	(18)
Other interest expenses	(26)	–
Interest on lease liabilities	(37)	(56)
Exchange (losses)/ gains	1,044	372
Bank charges	(35)	(20)
Fair value adjustment of Lender Warrants	67	2
Transaction costs on lender warrants	–	(51)
Net Finance expense	(560)	(903)

313

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

5. Other Disclosures

5.0 Post-Employment Benefits: Defined Benefit Obligation

Accounting policy:

Group companies operate various pension schemes. The schemes

are funded through payments to insurance companies or trustee-administered funds,

determined by periodic actuarial calculations. The Group has both defined benefit and

defined contribution plans.

Defined benefit plan

The Group operates a defined benefit pension plan in Switzerland, which requires contributions

to be made to a separately administered fund. The cost of providing benefits under the defined

benefit plan is determined using the projected unit credit method.

Remeasurements, comprising of actuarial gains and losses, are recognized in the statement

of financial position with a corresponding debit or credit to retained earnings through OCI

in the period in which they occur. Remeasurements are not reclassified to profit or loss in

subsequent periods.

Past service costs are recognized in profit or loss on the earlier of:

•

The date of the plan amendment or curtailment, and

•

The date that the Group recognizes related restructuring costs

Net interest is calculated by applying the discount rate to the net defined benefit liability or

asset. The Group recognizes the changes in the net defined benefit obligation due to service

costs comprising current service costs, past-service costs, gains and losses on curtailments

and non-routine settlements as part of operating expenses, and the net interest expense or

income as part of net finance costs in the consolidated statement of profit and loss.

	2025	2024
Plan assets	10,054	7,017
Obligation	(14,718)	(11,016)
Net liability	4,664	3,999

A defined benefit plan is a pension plan that is not a defined contribution plan. Typically,

defined benefit plans specify an amount of pension benefit that an employee will receive

upon retirement, typically dependent on one or more factors such as age, years of service,

and compensation. The benefits paid to employees in Switzerland qualify as a defined

benefit plan.

The pension plan for Swiss employees (“the Pension Fund”) is a defined benefit plan. The

Pension Fund provides benefits for retirement, disability, and surviving dependents that

meet or exceed the minimum benefits required under the Federal Law on Occupational

Retirement, Survivors’ and Disability Insurance (“BVG”), including the legal coordination

charge, which is also insured. The monthly premium to fund the Pension Fund’s benefits

is split equally between the employer and the employees. Contributions, which vary by

the age of the employees, range from 6-13% of the covered salary and are credited to the

employees’ individual retirement savings accounts. The Pension Fund is responsible for

capital investments and pursues an investment strategy with a prescribed investment policy.

The Group assumes an average retirement age of 65. Upon retiring (including early and

partial retirement), insured persons are entitled to a lifelong retirement pension if employees

do not choose to withdraw the entire balance, or portion thereof, of their individual retirement

savings accounts in the form of a capital payment.

The Pension Fund is administered by Allianz Suisse, Switzerland, which is legally separate

from the Group and is governed by a foundation board. In addition, there is a pension fund

commission comprised of two employee and two employer representatives. The duties of

the foundation board, as well as the pension fund commission, are laid out in the BVG and

the specific pension fund rules. They are required by law to act in the best interest of the

participants and are responsible for setting certain policies (e.g. investment, contribution,

and indexation policies) for the Pension Fund. At least four times a year, the foundation

board, as well as the pension fund commission, meet to analyze consequences and decide

on adjustments in the investment strategy.

315

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

Pursuant to the BVG, additional employer and employee contributions may be imposed

whenever a significant funding deficit arises in accordance with the BVG. In addition to

investment risk, the Pension Fund is exposed to actuarial risk, longevity risk, currency risk,

and interest rate risk.

In addition to the pension plan for Swiss employees, a defined benefit plan for Swiss

management also provides retirement benefits and risk insurance for death and disability

for components of remuneration in excess of the maximum insurable amount of salary under

the plan described above.

Movement of Net Defined-Benefit Liability

	2025	2024
Balance as at 1 January	3,999	2,081
Service costs	828	760
Admin costs	57	47
Past service costs	(106)	(38)
Employee benefit expenses	779	769
Net interest costs/(income)	31	18
Included in statement of profit and loss	810	787
Actuarial gains/(losses)
– Financial assumptions	(574)	1,104
– Demographic assumptions	–	–
– Experience adjustment	943	441
– Return on assets excluding interest income	202	274
	571	1,819
Exchange rate differences	44	(28)
Included in statement of comprehensive income*	615	1,792
Contributions by employer	(760)	(661)
Balance as at 31 December	4,664	3,999

*Excluding deferred tax impact as in Note 2.9

The principal assumptions used in determining post-employment (pension) benefit obligations

for the plan are shown below:

	2025	2024
Discount rate	1.25%	0.95%
Salary increase	3.00%	3.00%
Interest credit rate	1.25%	1.00%
Mortality base table	BVG2020	BVG2020
Longevity improvement	CMI2018; 1.25%	CMI2018; 1.25%

A quantitative sensitivity analysis for significant assumptions as at 31 December is shown

below:

	2025	2024
Discount rate
+ 25bps	(633)	(605)
- 25bps	682	407
Salary increase
+ 25bps	243	89
- 25bps	(242)	(314)
Interest credit rate
+ 25bps	247	61
- 25bps	(240)	(293)
Mortality base table
Life expectancy + 1 year	129	(19)
Life expectancy - 1 year	(127)	(216)

The sensitivity analyses have been determined based on a method that extrapolates the

impact on the defined benefit obligation as a result of reasonable changes in key assumptions

occurring at the end of the reporting period. The sensitivity analyses are based on a change

in a significant assumption, keeping all other assumptions constant. The sensitivity analyses

may not be representative of an actual change in the defined benefit obligation as it is unlikely

that changes in assumptions would occur in isolation from one another.

317

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

The following are the expected payments or contributions to the defined benefit plan in

future years:

	2025	2024
Within the next 12 months	701	627
Between 2 and 5 years	3,303	2,476
Between 6 and 10 years	4,727	3,503
Total expected payments	8,731	6,606

The average duration of the defined benefit plan obligation at the end of the reporting period

is 18 years (2024: 18 years).

Plan assets allocation

The asset allocation in the Swiss pension plan at 31 December was as follows:

	2025	2024
Bonds	6,524	4,553
Equities	–	–
Loans	215	149
Mortgages	1,052	766
Real Estate	2,145	1,441
Cash, derivatives and funds	118	108
	10,054	7,017

Plan assets in 2025 and 2024 do not include property occupied by or financial instruments

issued by ONWARD.

5.1 Commitments & Contingencies

Legal claim contingencies

As at 31 December 2025, the Group had no legal claim contingencies.

Guarantees

The Group has provided a guarantee to Wincasa for EUR 305k as collateral for the lease of

the office space in Lausanne and paid a deposit of EUR 8k to SPACES for the lease of the

office space in Eindhoven.

Royalties

The Group has entered into three license agreements with EPFL that will pay out royalties

in case the Company is able to generate revenues in the future for products directly linked

to these licenses. The royalty scheme with EPFL is based on net sales. To date, no royalties

have been paid as there is no product generating revenue.

On 27 September 2019, Neurorecovery Technologies Inc. (now ONWARD Medical Inc.) entered

into a license agreement with the Regents of the University of California acting through

Technology Development Group UCLA campus granting an exclusive license on certain

patents in certain fields of neuromodulation and spinal cord stimulation, and a non-exclusive

license on certain other patent rights. Various revenue milestone payments are due under

the exclusive license and royalty payments are due under the non-exclusive license. The

agreement contains various milestone and diligence obligations ranging from USD 10k to

USD 50k payable upon entering a phase III clinical trial, regulatory approval, and/or first

commercial sale. All milestone related payments due to UCLA were paid at 31 December

2025. Royalties are reported and paid on a quarterly basis and is included in Cost of Goods

Sold for 2025. During the upcoming years, royalty obligations are expected to be determined

as a percentage of net revenues as defined in the agreement, ranging from 2% to 3%, subject

to the geographical location of commercial sales.

On 8 October 2019, Neurorecovery Technologies Inc. (now ONWARD Medical Inc.) entered

into a license agreement with the California Institute of Technology (“Caltech”), the latter on

319

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

behalf of various intellectual property owners, including UCLA, University of Louisville, DEI

and USC, granting an exclusive license on certain technology in certain fields of epidural and

transcutaneous neuromodulation and a non-exclusive license of certain other intellectual

property. Various revenue milestone payments, diligence obligations, and royalty payments

are due under the license. These payments range from USD 20k to USD 75k payable upon FDA

approval, CE Mark certification, and/or first commercial sale. For the milestones triggered

by the FDA clearance received on 19 December 2024, an amount of EUR 131k is included in

trade payables at 31 December 2025 for the second tranche due. Royalties are reported and

paid on a quarterly basis and is included in Cost of Goods Sold for 2025. During the upcoming

years, royalty obligations are expected to be determined as a percentage of

net revenues

as defined in the agreement, ranging from 2% to 4%, subject to the geographical location of

commercial sales.

5.2 Related Party Transactions

Note 1.1 provides the information about the Group’s structure including the details of the

subsidiaries. Transactions between the Company and its subsidiaries have been eliminated

on consolidation and are not disclosed in the notes.

The Group considers the Board and the Management Team to be key management as

defined in IAS 24 ‘Related parties.’ Full details of the remuneration of the board (CEO and

non-executives) are included in the Remuneration report.

	Salary,
	bonuses	Pension
	and other	premiums
	(short-term	(post-	Share-
	employee	employment	based
2025	benefits)	benefits)	payment	Total
Management Team, excluding CEO	2,850	151	499	3,500
CEO	938	117	824	1,879
Non-Executive Directors	534	–	227	761
	4,322	268	1,550	6,140

	Salary,
	bonuses	Pension
	and other	premiums
	(short-term	(post-	Share-
	employee	employment	based
2024	benefits)	benefits)	payment	Total
Management Team, excluding CEO	2,311	77	618	3,007
CEO	1,211	72	757	2,040
Non-Executive Directors	691	–	352	1,043
	4,213	149	1,727	6,089

321

Notes to the Consolidated Financial Statements

ONWARD

Medical Annual Report 2025

5.3 Events After the Reporting Period

Subsequent to 31 December 2025, the Group reached an agreement in principle with the

landlord to extend the lease for the office in Lausanne, Switzerland, for an additional five-

year period. As this extension was not contractually agreed or legally enforceable at the

reporting date, it was not included in the determination of the lease term or lease liability as

at 31 December 2025. The lease extension will be accounted for in the period in which the

agreement becomes legally enforceable.

In addition, the Group granted 1,302,500 stock options to employees, including the CEO, with

an exercise price of EUR 4.37. The conditions of the existing plan as explained in Note 2.9

applies to this grant.

Company

Financial

Statements

325

ONWARD

Medical Annual Report 2025

Company

Statement of Income

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Revenue

2,946

Less: Cost of goods sold

(976)

(10)

Gross profit

1,970

Operating expenses

(44,209)

(40,164)

Operating result for the period

(42,239)

(40,126)

Grant and other income

416

658

Net finance expense

(410)

(1,916)

Result after tax

(42,233)

(41,384)

Income tax expenses

–

Share in result of participating interests

446

5,658

Result after tax

(41,787)

(35,725)

Company Financial Statements

The notes on pages

331

341

are an integral part of these separate financial statements.

327

ONWARD

Medical Annual Report 2025

Company

Balance Sheet

(Before appropriation on result)

For the Year Ended 31 December

All amounts in EUR ‘000

Notes

2025

2024

Assets

158

105

3,796

2,372

Non-current assets

Tangible fixed assets

Financial fixed assets

3,954

2,477

Current assets

Trade and other receivables

20,

371

6,392

Cash at bank and in hand

48,369

56,989

68,

740

63,381

72,694

65,858

Company Financial Statements

329

ONWARD

Medical Annual Report 2025

Equity & Liabilities

Equity and reserves

Issued capital

6,721

5,355

Share premium

264,354

217,774

Other reserves

2,914

3,820

Legal reserve: Currency translation differences

(446)

625

Retained earnings

(176,440)

(143,795)

Result for the year

(41,787)

(35,725)

Total equity

55,316

48,054

Provisions

–

Non-current liabilities

13,127

14,016

Current liabilities

4,251

3,788

72,694

65,858

The notes on pages

331

341

are an integral part of these separate financial statements.

Company Financial Statements

331

ONWARD

Medical Annual Report 2025

Notes to the Company

Financial Statements

A. Presentation of Financial Statements and Recognition and Measurement Principles

The description of the activities of ONWARD Medical NV (the company) and the company

structure, as included in the notes to the consolidated financial statements, also applies to

the company financial statements.

The company is the sole shareholder of the following subsidiaries:

•

ONWARD Medical SA, based in Switzerland

•

ONWARD Medical Inc, based in the United States of America

These separate financial statements have been prepared in accordance with Title 9, Book

2 of the Dutch Civil Code. For setting the principles for the recognition and measurement

of assets and liabilities and determination of results for its separate financial statements,

the Company makes use of the option provided in section 2:362(8) of the Dutch Civil Code.

This means that the principles for the recognition and measurement of assets and liabilities

and determination of the result (hereinafter referred to as principles for recognition and

measurement) of the separate financial statements of the Company are the same as those

applied for the consolidated EU-IFRS financial statements. These principles also include the

classification and presentation of financial instruments, being equity instruments or financial

liabilities. In case no other principles are mentioned, refer to the accounting principles as

described in the consolidated financial statements. For an appropriate interpretation of

these statutory financial statements, the separate financial statements should be read in

conjunction with the consolidated financial statements.

Information on the use of financial instruments and on related risks for the group is provided

in the notes to the consolidated financial statements of the group.

B. Revenue & Other Income

Operating income relates to grant and other income received. Government subsidies have

been received for the research and development of several development projects. There are

no unfulfilled conditions or contingencies attached to these subsidies.

2025

2024

Revenue

2,946

Government subsidies (EU)

411

507

Other income

151

Total revenues and other income

3,362

706

Company Financial Statements

333

ONWARD

Medical Annual Report 2025

(In EUR 000)

Recognized

Grant

Recognized

as Grant

received in

as Grant

Grants

Total Grant*

Income

advance as

Income

cumulative

per 31-12-

2025

2024

before 2024

2025

BESTABLE

100

–

(16)

100

–

EISMEA - ReverseParalysis***

292

232

–

EISMEA - NEMO BMI***

144

–

(13)

Eurostars Impulse

500

176

150

174

–

Rewire

360

(38)

SH-ARC

500

–

(296)

MJFF SPARKL

–

EISMEA – Reverse Stroke

686

–

(240)

Total

411

507

419

(587)

C. Operating Expenses

Operating expenses by nature are as follows:

2025

2024

Wages and salaries

(1,499)

(1,212)

Social security costs (includes WBSO benefit)

(58)

Pension costs – other

(81)

(64)

Share-based benefit expenses

(115)

(370)

Other labor costs

(674)

(617)

Recharged costs

(31,540)

(29,722)

Other operating expenses

(10,283)

(8,051)

Depreciation and amortization

(67)

(70)

(44,209)

(40,164)

The increase in Recharged costs is driven by Research and Development, Clinical, Regulatory

and Quality, and Operational expenses due to commercialisation of our ARC

product and

advancements made on ARC

platforms (mainly in Switzerland) which increased the charge

from Switzerland and United States to the Netherlands, respectively, under the existing

agreements. Other operating expenses represents external and travel costs.

As at 31 December 2025, the Company had 17.4 full-time equivalents employed by its Dutch

entity (2024: 12.4), 91.9 full-time equivalents employed by its Swiss entity (2024: 76.15), and

28 full-time equivalents employed by its U.S. entity (2024: 14).

D. Net Finance Expense

2025

2024

Interest income

477

550

Interest on loans

(1,655)

(1,710)

Interest banks

–

Interest on lease liabilities

(6)

Amortisation of transaction costs on loan

(467)

(212)

Exchange losses

1,263

(523)

Bank charges

(22)

(15)

Net Finance expense

(410)

(1,916)

The increase is the result of interest expense and amortisation of transaction costs on Runway

Growth loan, offset by a decrease in exchange losses.

Company Financial Statements

335

ONWARD

Medical Annual Report 2025

E. Income Tax Expense

2025

2024

Current income tax

–

Deferred income tax

–

Total corporate income tax in profit and loss

–

Current income tax charge at tax rate of 25.8%

10,848

10,624

Non-deductible expenses

(153)

(1,664)

Net operating losses and temporary differences not recognized

10,695

(8,960)

–

The effective tax rate was 0% in 2025 (2024: 0%), which is lower than the statutory income tax

rate of 25.8% (2023: 25.8%) in the Netherlands. The difference is primarily due to nondeductible

expenses relating to share-based compensation and the net operating losses for which no

deferred tax asset can be recognized. The uncertainty is based on insufficient evidence of

future sources of income to support the realization of a deferred tax asset due to the Company

being loss-making with limited tax planning opportunities.

For the unused operating losses of EUR 211M (2024: EUR 166M) no deferred tax is recognized.

These losses can be carried forward indefinitely subject to local tax rules.

F. Share in Results from Participating Interests

An amount of EUR 0.03M (2024: EUR 5.45M) of share in results from participating interests

relates to Group companies.

G. Tangible Fixed Assets

Cost

Demonstration

Office

Right-of-

/ Evaluation

Total

Equipment

use-asset

Equipment

At 1 January 2024

734

–

830

Additions

–

Disposal

–

At 31 December 2024

738

148

–

885

Additions

121

Disposal

–

At 31 December 2025

764

217

1,007

Accumulated Depreciation

Demonstration

Office

Right-of-

/ Evaluation

Total

Equipment

use-asset

Equipment

At 1 January 2024

(704)

(9)

–

(713)

Depreciation for the year

(21)

(49)

–

(70)

Disposal

–

At 31 December 2024

(725)

(58)

()

(783)

Depreciation for the year

(12)

(51)

(3)

(66)

Disposal

–

At 31 December 2025

(737)

(109)

(3)

(849)

Company Financial Statements

337

ONWARD

Medical Annual Report 2025

Net Book Value

Demonstration

Office

Right-of-

/ Evaluation

Total

Equipment

use-asset

Equipment

At 31 December 2024

–

105

At 31 December 2025

108

158

H. Financial Fixed Assets

Financial fixed assets consist of participating interests in Group companies. Financial fixed

assets are accounted for in the Company financial statements at net asset value. They are

tested for impairment whenever events or changes in circumstances indicate that the carrying

amount may not be recoverable. An impairment loss is recognized for the amount by which

the asset’s carrying amount exceeds its recoverable amount.

2025

2024

Cost

2,372

807

Accumulated impairments

–

Net book value at 1 January

2,372

807

Revaluations through OCI

(491)

(1,820)

Exchange differences

(163)

609

Group share-based payment scheme

2,524

2,350

Share in result of participating interests

(446)

5,659

Provision: negative participating interest

–

(5,233)

Net change

1,424

1,565

Cost

3,796

2,372

Accumulated impairments

–

Net book value at 31 December

3,796

2,372

The provision for negative participating interest was reversed in 2024.

I. Trade & Other Receivables

Amounts due from Group companies are recognized initially at fair value and subsequently at

amortized cost. Amortized cost is determined using the effective interest rate. The Company

recognizes a credit loss for financial assets (such as a loan) based on an expected credit loss

(ECL), which will occur in the coming twelve months or – after a significant decrease in credit

quality or when the simplified model can be used – based on the entire remaining loan term.

For intercompany receivables, the ECL would be applicable as well, however this could cause

differences between equity in the consolidated and separate financial statements. For this

reason, the Company elected to eliminate these differences through the respective receivable

account in the separate financial statements.

2025

2024

Indirect tax receivable

323

Receivables from related parties – group companies

18,424

5,124

Receivables from related parties - other

–

Trade and other receivables

547

362

Advance payments made

1,077

790

20,

371

6,392

The increase in receivables from group companies compared to the prior year primarily

reflects a correction to the appropriation of intercompany cost allocations relating to the

prior year. The current year balance reflects the normal appropriation of costs.

Company Financial Statements

339

ONWARD

Medical Annual Report 2025

J. Cash at Bank, in Hand & Fixed Term Deposits

2025

2024

Cash at bank

4,314

8,989

Short-term deposits

44,055

48,000

Cash at bank and in hand

48,369

56,989

Cash at bank, in hand, and fixed term deposits

48,369

56,989

Cash at banks earns interest at floating rates based on daily bank deposit rates. Short-term

deposits are made for varying periods of between one day and three months, depending on

the immediate cash requirements of the Group, and earn interest at the respective short-term

deposit rates. At 31 December 2025, the Group had no fixed term deposits or bank overdrafts.

All cash is freely at the disposal of the company.

K. Shareholders’ Equity

For the statement of changes in equity for the year ended 31 December 2025, please refer

to consolidated statement of changes in equity in the consolidated financial statements.

Additional information on the shareholders’ equity is disclosed in note 4.0 of the consolidated

financial statements.

L. Provisions

2025

2024

Opening balance as at 1 January

–

5,233

Negative participating interest

–

Reversal of provision for negative participating interest

–

(5,233)

Balance as at 31 December

–

M. Non-Current Liabilities

2025

2024

Balance as at 31 December

13,127

14,015

2025

Runway

Others

Growth

Balance as at 1 January

13,972

Loan amount received

–

Interest/cumulative dividend accrued during the year

–

1,655

Transaction cost amortization

–

467

Loan amount repaid during the year

–

Interest paid during the year

–

(1,661)

Warrants issued to lender

–

Long term lease liability and others

–

Foreign currency translation difference

–

(1,359)

Net book value as 31 December

13,074

N. Current Liabilities

Amounts due to Group companies recognized as financial liabilities at amortized cost as per

the policy in the consolidated financial statements.

2025

2024

Trade payables

2,038

471

Tax liabilities

–

Payables from related parties

–

Other payables

1,205

2,419

Grant-related payables

587

430

Warrants issued to lender

370

437

4,251

3,788

Company Financial Statements

341

ONWARD

Medical Annual Report 2025

O. Compensation of the Board Of Directors

The members of the Board and the Management Team are considered key management

personnel as defined in IAS 24 ‘Related party disclosures.’ For details on their remuneration,

reference is made to note 5.2 of the consolidated financial statements. Full details of the

remuneration of the board (CEO and non-executives) are included in the Remuneration report.

P. Fees for Audit & Other Services

In accordance with article 382.a of Part 9, Book 2, of the Netherlands Civil Code, the total audit

cost can be specified as follows. The fees have been allocated for the audit of the financial

statements to the financial year to which the financial statements relate, irrespective of when

the work has been performed.

EY Accountants B.V

2025

2024

Audit of financial statements

511

362

Other assurance services

617

1,128

372

Other assurance services mainly relate to capital raise and other permissible services

provided by the auditor and its network.

Q. Subsequent Events

For subsequent events, please refer to Note 5.3 of the Consolidated Financial Statements.

R. Proposed Appropriation of Result

The Board of Directors proposes to deduct the net loss in full to the retained earnings.

Company Financial Statements

Other

Information

345

ONWARD

Medical Annual Report 2025

Independent auditor’s report

To: the shareholders and board of directors of ONWARD Medical N.V.

Report on the audit of the financial statements 2025 included in the annual report

Our opinion

We have audited the accompanying financial statements for the financial year ended

31 December 2025 of ONWARD Medical N.V. based in Amsterdam, the Netherlands. The

financial statements comprise the consolidated financial statements and the company

financial statements.

In our opinion:

•

The consolidated financial statements give a true and fair view of the financial position

of ONWARD Medical N.V. as at 31 December 2025 and of its result and its cash flows for

2025 in accordance with International Financial Reporting Standards as adopted in the

European Union (EU-IFRSs) and with Part 9 of Book 2 of the Dutch Civil Code

•

The company financial statements give a true and fair view of the financial position of

ONWARD Medical N.V. as at 31 December 2025 and of its result for 2025 in accordance

with Part 9 of Book 2 of the Dutch Civil Code

Other

Information

The consolidated financial statements comprise:

•

The consolidated statement of financial position as at 31 December 2025

•

The following statements for the year ended 31 December 2025: the consolidated statements

of profit and loss, comprehensive income, changes in equity and cash flows

•

The notes comprising material accounting policy information and other

explanatory information

The company financial statements comprise:

•

The company balance sheet as at 31 December 2025

•

The company statement of income for the year ended 31 December 2025

•

The notes comprising a summary of the accounting policies and other

explanatory information

Basis for our opinion

We conducted our audit in accordance with Dutch law, including the Dutch Standards

on Auditing. Our responsibilities under those standards are further described in the Our

responsibilities for the audit of the financial statements section of our report.

347

ONWARD

Medical Annual Report 2025

We are independent of ONWARD Medical N.V. in accordance with the EU Regulation on

specific requirements regarding statutory audit of public-interest entities, the Wet toezicht

accountantsorganisaties (Wta, Audit firms supervision act), the Verordening inzake de

onafhankelijkheid van accountants bij assurance-opdrachten (ViO, Code of Ethics for

Professional Accountants, a regulation with respect to independence) and other relevant

independence regulations in the Netherlands. Furthermore, we have complied with the

Verordening gedrags- en beroepsregels accountants (VGBA, Dutch Code of Ethics for

Professional Accountants).

We believe the audit evidence we have obtained is sufficient and appropriate to provide a

basis for our opinion.

Material uncertainty related to going concern

We draw attention to the Going concern section in the notes 1.4 of the consolidated financial

statements which indicates that the combination of uncertainty surrounding future cash

inflows, the potential for a future covenant breach under the Runway Growth loan facility, and

the current expectation that existing cash resources alone may not be sufficient to fund its

operations for at least the twelve months following the date of the financial statements. These

conditions indicate the existence of a material uncertainty that may cast significant doubt

about the company’s ability to continue as a going concern. We refer to the section “Our audit

response related to going concern” that describes how the going concern assumption and

the relevant events and conditions that may cast significant doubt on the company’s ability

to continue as a going concern were addressed in our audit. Our opinion is not modified in

respect of this matter.

Information in support of our opinion

We designed our audit procedures in the context of our audit of the financial statements as a

whole and in forming our opinion thereon. The following information in support of our opinion

and any findings were addressed in this context, and we do not provide a separate opinion

or conclusion on these matters.

Our understanding of the business

ONWARD Medical N.V. (“The Company” and, together with its consolidated subsidiaries, “the

group”) is developing and commercializing innovative therapies to enable functional recovery

for people with spinal cord injury. We paid specific attention in our audit to a number of areas

driven by the operations of the group and our risk assessment.

We determined materiality and identified and assessed the risks of material misstatement

of the financial statements, whether due to fraud or error in order to design audit procedures

responsive to those risks and to obtain audit evidence that is sufficient and appropriate to

provide a basis for our opinion.

Materiality

€ 1.3 million (2024: € 1.1 million)

Benchmark applied

3% of total operating expenses for the year ended 31 December

2025 (2024: 3%)

Explanation

R&D companies such as ONWARD Medical N.V. which are in

the early stages of commercialization, report modest revenues

and the stakeholders expect the company to operate at a loss.

The value that owners or others generally attribute to these

companies is primarily based on the promise of future success

of the products. Based on these factors we deem operating

expenses to be a suitable benchmark, as it is one of the most

important measures for the level of cash used in operating

activities to support the advancement of the development and

commercialization of the company’s products.

We initially planned our audit with a materiality of €1.2 million

based on 3% of the anticipated total operating expenses for the

year ended 31 December 2025 and determined not to revise the

materiality amount upwards as our audit progressed.

Other Information

349

ONWARD

Medical Annual Report 2025

We have also taken into account misstatements and/or possible misstatements that in our

opinion are material for the users of the financial statements for qualitative reasons.

We agreed with the audit committee of the board of directors that misstatements in excess of

€60,000, which are identified during the audit, would be reported to them, as well as smaller

misstatements that in our view must be reported on qualitative grounds.

Scope of the group audit

ONWARD Medical N.V. is at the head of a group of entities that consists of the headquarters

in the Netherlands, ONWARD Medical S.A., the science and engineering center in Switzerland

and ONWARD Medical Inc., the field clinical and sales organization in the US. The financial

information of this group is included in the financial statements.

We are responsible for planning and performing the group audit to obtain sufficient appropriate

audit evidence regarding the financial information of the entities or business units within the

group as a basis for forming an opinion on the financial statements. We are also responsible

for the direction, supervision, review and evaluation of the audit work performed for purposes

of the group audit. We bear the full responsibility for the auditor’s report.

Based on our understanding of the group and its environment, the applicable financial

framework and the group’s system of internal control, we identified and assessed risks

of material misstatement of the financial statements and the significant accounts and

disclosures. Based on this risk assessment, we determined the nature, timing and extent of

audit work performed, including the entities or business units within the group (components)

at which to perform audit work. For this determination we considered the nature of the

relevant events and conditions underlying the identified risks of material misstatements for

the financial statements, the association of these risks to components and the materiality

or financial size of the components relative to the group.

As the processes of the group are highly centralized and all transactions are initiated,

recorded, processed and reported on central level, we performed the audit work centrally

ourselves for all three components of the group.

This resulted in a coverage of 100% of the net loss for the period, 100% of total operating

expenses and 100% of total assets.

By performing the audit work mentioned above at the entities or business units within the

group, together with additional work at group level, we have been able to obtain sufficient

and appropriate audit evidence about the group’s financial information to provide an opinion

on the financial statements.

Teaming and use of specialists

We ensured that the audit team included the appropriate skills and competences which

are needed for the audit of a listed client in the medical technology industry. We included

Turnaround and Restructuring specialists, actuaries, specialists in the areas of IT audit,

forensics, share based payments and income tax.

Our audit response related to going concern

We refer to the section “Material uncertainty related to going concern” above. Based on

our procedures performed, we concluded that a material uncertainty exists which may cast

significant doubt about the company’s ability to continue as a going concern. Our conclusions

are based on the audit evidence obtained up to the date of our auditor’s report. However,

future events or conditions may cause a company to cease to continue as a going concern.

The board of directors evaluated the expected cash flows and made a specific assessment

of the company’s ability to continue as a going concern and to continue its operations for

the foreseeable future. As disclosed in Note 1.4 to the financial statements, amongst others,

the following events and conditions denote a material uncertainty about the going concern

assumption for the company: The forecast includes significant expenditures relating to

the development and commercialization of the company’s products. The board notes the

combination of uncertainty surrounding future cash inflows and the Company’s reliance on

continued financial support, along with other matters as set forth in Note 1.4, indicate the

existence of a material uncertainty which may cast significant doubt about the company’s

ability to continue as a going concern. The company explores additional fundraising options.

We further refer to Section ‘Risk-Management and Control’ of the annual report that includes

the detailed description of the ‘Risks related to the Company’s financial position, need for

additional capital and taxation’. The financial statements have been prepared on a going

concern basis.

Other Information

351

ONWARD

Medical Annual Report 2025

We discussed and evaluated the specific assessment with the board of directors exercising

professional judgment and maintaining professional skepticism. We involved our Turnaround

and Restructuring Specialists and specifically focused on, among other things, the impact of

the events and conditions that are relevant for the company’s ability to continue as a going

concern and mitigating factors, significant assumptions, the process followed by the board

of directors to make the specific assessment and management bias that could represent a

risk of material misstatement due to fraud.

We considered whether the board of directors’ going concern assessment, based on our

knowledge and understanding obtained through our audit of the financial statements or

otherwise, contains all relevant events or conditions that may cast significant doubt on the

company’s ability to continue as a going concern. Furthermore, we evaluated forecasted

cash flows and the substantiation for significant assumptions, with a focus on whether the

company will have sufficient liquidity to continue to meet its obligations as they fall due and

will continue to comply with loan covenants in the next twelve months and the foreseeable

future. We have specifically assessed the anticipated impact of non-compliance on the

cashflow forecast. Furthermore, we have performed sensitivity analyses on revenue and costs

projections to assess the impact on the cashflow forecasts and continued compliance with

loan covenants. Finally, we evaluated relevant disclosures and considered whether relevant

events and conditions, mitigating factors and significant assumptions related to going

concern have been disclosed and particularly whether these disclosures adequately convey

the degree of uncertainty.

Our focus on fraud and non-compliance with laws and regulations

Our responsibility

Although we are not responsible for preventing fraud or non-compliance and we cannot

be expected to detect non-compliance with all laws and regulations, it is our responsibility

to obtain reasonable assurance that the financial statements, taken as a whole, are free

from material misstatement, whether caused by fraud or error. The risk of not detecting

a material misstatement resulting from fraud is higher than for one resulting from error,

as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the

override of internal control.

Our audit response related to fraud risks

We identified and assessed the risks of material misstatements of the financial statements due

to fraud. During our audit we obtained an understanding of the company and its environment

and the components of the system of internal control, including the risk assessment process

and the board of directors’ process for responding to the risks of fraud and monitoring the

system of internal control, as well as the outcomes.

We refer to Section “Risk-Management and Control” of the annual report for the board of

directors’ risk assessment after consideration of potential fraud risks.

We evaluated the design and relevant aspects of the system of internal control and in particular

the fraud risk assessment, as well as the Code of business conduct and ethics, whistle blower

procedures and incident registration. We evaluated the design and the implementation of

internal controls designed to mitigate fraud risks.

As part of our process of identifying fraud risks, we evaluated fraud risk factors with respect

to financial reporting fraud, misappropriation of assets and bribery and corruption in close

co-operation with our forensic specialists. We evaluated whether these factors indicate that

a risk of material misstatement due to fraud is present.

We incorporated elements of unpredictability in our audit. We also considered the outcome

of our other audit procedures and evaluated whether any findings were indicative of fraud

or non-compliance.

Other Information

353

ONWARD

Medical Annual Report 2025

We addressed the risks related to management override of controls, as this risk is present in all

organizations. For these risks we have, among other things, performed procedures to evaluate

whether the selection and application of accounting policies by the company, particularly

those relating to subjective measurements and complex transactions, as disclosed in Note

1.6 “Significant Accounting Judgments, Estimates and Assumptions” to the consolidated

financial statements, may be indicative to fraudulent financial reporting. We have also used

data analysis to identify and address high-risk journal entries and other adjustments made

in the financial reporting process. We evaluated the business rationale (or the lack thereof)

of significant extraordinary transactions, including those with related parties.

When identifying fraud risks, we presumed that there are risks of fraud in revenue recognition.

We have identified a fraud risk for improper revenue recognition due to incorrect cut-off by

shifting revenues from the subsequent year to current year or by recording fictitious sales.

We describe the audit procedures responsive to the risk of fraud in revenue recognition in the

description of our audit approach for the key audit matter “Revenue recognition”.

We considered available information and made enquiries of relevant executives, directors,

legal, compliance, human resources and the audit committee of the board of directors.

The fraud risk we identified, enquiries and other available information did not lead to specific

indications for fraud or suspected fraud potentially materially impacting the view of the

financial statements.

Our audit response related to risks of non-compliance with laws and regulations

We performed appropriate audit procedures regarding compliance with the provisions of

those laws and regulations that have a direct effect on the determination of material amounts

and disclosures in the financial statements. Furthermore, we assessed factors related to the

risks of non-compliance with laws and regulations that could reasonably be expected to have

a material effect on the financial statements from our general industry experience, through

discussions with the board of directors, reading minutes, and performing substantive tests

of details of classes of transactions, account balances or disclosures.

We received a confirmation that there were no legal cases. We inspected the correspondence

with regulatory authorities and remained alert to any indication of (suspected) non-compliance

throughout the audit. Finally, we obtained written representations that all known instances

of non-compliance with laws and regulations have been disclosed to us.

Our key audit matters

Key audit matters are those matters that, in our professional judgment, were of most

significance in our audit of the financial statements. We have communicated the key audit

matters to the audit committee of the board of directors. The key audit matters are not a

comprehensive reflection of all matters discussed.

In addition to the matter described in the Material uncertainty related to going concern

section, we determined ‘Revenue recognition’ as a key audit matter. The key audit matter

relating to valuation of intangible assets which was included in our last year’s auditor’s report,

is not considered a key audit matter for this year following our risk re-assessment in light of

the regulatory approvals obtained and the company’s market capitalization.

Other Information

355

ONWARD

Medical Annual Report 2025

Revenue recognition

Risk

The company’s business depends on the successful

commercialization of the investigational devices. In 2025, the

company had one product available for sale and recorded

revenues from Sales of ARC

Medical Devices (Revenue from

sales of devices). Lower-than-expected revenue could harm

the Company’s business, financial condition, compliance with

financial covenants, and results of operations, as discussed in

more detail in Section ‘Risk-Management and Control’ of the

annual report that includes the detailed description of the ‘Risks

related to the Company’s financial position, need for additional

capital and taxation’.

As a result of the identified pressures on management and

the first-time recording of revenue from sales of devices

in accordance with IFRS 15 ‘Revenues from Contracts with

Customers’, we identified a fraud risk for improper revenue

recognition due to incorrect cut-off by shifting revenues from the

subsequent year to current year or by recording fictitious sales.

Reference is made to note

2.1 Revenues and Other Income

the consolidated financial statements, for material accounting

policy information and other explanatory information on the

company’s

revenue from sales of devices.

Our audit approach

As part of our audit procedures, we evaluated the appropriateness

of the company’s revenue recognition accounting policies

in accordance with IFRS 15. We obtained an understanding,

evaluated the design and implementation of the company’s

controls relating to revenue recognition.

Our audit procedures included, amongst others, testing of

individual sales contracts and transactions to assess proper

identification of the identifiable performance obligations in the

contracts and correct allocation of the transaction price to these

performance obligations and recognition hereof.

We also tailored our audit procedures to address our fraud risk.

We used data analytics to correlate revenues to cash receipts,

identify unusual trends and tested credit notes issued during

2026 for prior year sales adjustments. Furthermore, we tested

sales transactions before and after year end to assess whether

revenue was recognized in the correct period by, amongst others,

inspection of shipping documents, delivery notes and customer

acceptance documents.

We also evaluated the adequacy of the related disclosures.

Key observations

We consider the company’s accounting policies related to

revenues appropriate. Based on the audit procedures performed,

we did not identify any material misstatement in the revenue

from sale of devices recognized in the financial statements.

Other Information

357

ONWARD

Medical Annual Report 2025

Report on other information included in the annual report

The annual report contains other information in addition to the financial statements and our

auditor’s report thereon.

Based on the following procedures performed, we conclude that the other information:

•

Is consistent with the financial statements and does not contain material misstatements

•

Contains the information as required by Part 9 of Book 2 of the Dutch Civil Code for the

management report and the other information as required by Part 9 of Book 2 of the

Dutch Civil Code and as required by Sections 2:135b and 2:145 sub section 2 of the Dutch

Civil Code for the remuneration report.

We have read the other information. Based on our knowledge and understanding obtained

through our audit of the financial statements or otherwise, we have considered whether the

other information contains material misstatements. By performing these procedures, we

comply with the requirements of Part 9 of Book 2 and Section 2:135b sub-Section 7 of the

Dutch Civil Code and the Dutch Standard 720. The scope of the procedures performed is

substantially less than the scope of those performed in our audit of the financial statements.

The board of directors is responsible for the preparation of the other information, including

the management report in accordance with Part 9 of Book 2 of the Dutch Civil Code and other

information required by Part 9 of Book 2 of the Dutch Civil Code. The board of directors is

responsible for ensuring that the remuneration report is drawn up and published in accordance

with Sections 2:135b and 2:145 sub section 2 of the Dutch Civil Code.

Description of responsibilities regarding the financial statements

Responsibilities of the board of directors for the financial statements

The board of directors is responsible for the preparation and fair presentation of the financial

statements in accordance with EU-IFRSs and Part 9 of Book 2 of the Dutch Civil Code.

Furthermore, the board of directors is responsible for such internal control as the board of

directors determines is necessary to enable the preparation of the financial statements that

are free from material misstatement, whether due to fraud or error.

As part of the preparation of the financial statements, the board of directors is responsible

for assessing the company’s ability to continue as a going concern. Based on the financial

reporting framework mentioned, the board of directors should prepare the financial statements

using the going concern basis of accounting unless the board of directors either intends to

liquidate the company or to cease operations, or has no realistic alternative but to do so. The

board of directors should disclose events and circumstances that may cast significant doubt

on the company’s ability to continue as a going concern in the financial statements.

Our responsibilities for the audit of the financial statements

Our objective is to plan and perform the audit engagement in a manner that allows us to

obtain sufficient and appropriate audit evidence for our opinion.

Our audit has been performed with a high, but not absolute, level of assurance, which means

we may not detect all material misstatements, whether due to fraud or error during our audit.

Misstatements can arise from fraud or error and are considered material if, individually or

in the aggregate, they could reasonably be expected to influence the economic decisions of

users taken on the basis of these financial statements. The materiality affects the nature,

timing and extent of our audit procedures and the evaluation of the effect of identified

misstatements on our opinion.

We have exercised professional judgment and have maintained professional skepticism

throughout the audit, in accordance with Dutch Standards on Auditing, ethical requirements

and independence requirements. The Information in support of our opinion section above

Other Information

359

ONWARD

Medical Annual Report 2025

includes an informative summary of our responsibilities and the work performed as the basis

for our opinion.

Our audit further included among others:

•

Performing audit procedures responsive to the risks identified, and obtaining audit

evidence that is sufficient and appropriate to provide a basis for our opinion

•

Obtaining an understanding of internal control relevant to the audit in order to design

audit procedures that are appropriate in the circumstances, but not for the purpose of

expressing an opinion on the effectiveness of the company’s internal control

•

Concluding on the appropriateness of the board of directors’ use of the going concern

basis of accounting, and based on the audit evidence obtained, whether a material

uncertainty exists related to events or conditions that may cast significant doubt on

the company’s ability to continue as a going concern. If we conclude that a material

uncertainty exists, we are required to draw attention in our auditor’s report to the related

disclosures in the financial statements or, if such disclosures are inadequate, to modify

our opinion. Our conclusions are based on the audit evidence obtained up to the date of

our auditor’s report. However, future events or conditions may cause a company to cease

to continue as a going concern

•

Evaluating the appropriateness of accounting policies used and the reasonableness of

accounting estimates and related disclosures made by the board of directors

•

Evaluating the overall presentation, structure and content of the financial statements,

including the disclosures

•

Evaluating whether the financial statements represent the underlying transactions and

events in a manner that achieves fair presentation

Communication

We communicate with the audit committee of the board of directors regarding, among other

matters, the planned scope and timing of the audit and significant audit findings, including

any significant findings in internal control that we identify during our audit.

In this respect we also submit an additional report to the audit committee of the board of

directors in accordance with Article 11 of the EU Regulation on specific requirements regarding

statutory audit of public-interest entities. The information included in this additional report

is consistent with our audit opinion in this auditor’s report.

We provide the audit committee of the board of directors with a statement that we have

complied with relevant ethical requirements regarding independence, and to communicate

with them all relationships and other matters that may reasonably be thought to bear on our

independence, and where applicable, related safeguards.

From the matters communicated with the audit committee of the board of directors, we

determine the key audit matters: those matters that were of most significance in the audit

of the financial statements. We describe these matters in our auditor’s report unless law

or regulation precludes public disclosure about the matter or when, in extremely rare

circumstances, not communicating the matter is in the public interest.

Other Information

361

ONWARD

Medical Annual Report 2025

Report on other legal and regulatory requirements and ESEF

Engagement

We were engaged by the general meeting as auditor of ONWARD Medical N.V. on 11 October

2021, as of the audit for the year 2021 and have operated as statutory auditor ever since

that date.

No prohibited non-audit services

We have not provided prohibited non-audit services as referred to in Article 5(1) of the EU

Regulation on specific requirements regarding statutory audit of public-interest entities.

European Single Electronic Reporting Format (ESEF)

ONWARD Medical N.V. has prepared the annual report in ESEF. The requirements for this

are set out in the Delegated Regulation (EU) 2019/815 with regard to regulatory technical

standards on the specification of a single electronic reporting format (hereinafter: the RTS

on ESEF).

In our opinion the annual report prepared in the XHTML format, including the (partially)

marked-up consolidated financial statements as included in the reporting package by

ONWARD Medical N.V., complies in all material respects with the RTS on ESEF.

The board of directors is responsible for preparing the annual report, including the financial

statements, in accordance with the RTS on ESEF, whereby the board of directors combines

the various components into a single reporting package.

Our responsibility is to obtain reasonable assurance for our opinion whether the annual report

in this reporting package complies with the RTS on ESEF.

We performed our examination in accordance with Dutch law, including Dutch Standard

3950N, ”Assurance-opdrachten inzake het voldoen aan de criteria voor het opstellen van een

digitaal verantwoordingsdocument” (assurance engagements relating to compliance with

criteria for digital reporting). Our examination included amongst others:

•

Obtaining an understanding of the company’s financial reporting process, including the

preparation of the reporting package

•

Identifying and assessing the risks that the annual report does not comply in all material

respects with the RTS on ESEF and designing and performing further assurance

procedures responsive to those risks to provide a basis for our opinion, including:

•

Obtaining the reporting package and performing validations to determine

whether the reporting package containing the Inline XBRL instance document

and the XBRL extension taxonomy files, has been prepared in accordance with

the technical specifications as included in the RTS on ESEF

•

Examining the information related to the consolidated financial statements in the

reporting package to determine whether all required mark-ups have been applied

and whether these are in accordance with the RTS on ESEF.

Eindhoven, 30 March 2026

EY Accountants B.V.

Signed by J.C.F. Lemmens

Other Information

363

ONWARD

Medical Annual Report 2025

Definitions and Abbreviations

The following definitions are used in this report:

510(k)

Clearance under Section 510(k) of the FDCA

(US)

AGM

Annual General Meeting

ASC

Ambulatory surgery centers

Berufsgenossenschaft

BDD

Breakthrough Device Designation -

Designation given by the FDA to allow a

timely access to devices providing a more

effective treatment or diagnosis of life-

threatening diseases by speeding-up their

development, assessment, and review

Brain – Computer Interface (BCI)

Electrical signal produced by the brain is

recorded by a device and is then translated

into a signal allowing the stimulation of

the spinal cord, enabling thought-driven

restoration of movement

Caltech

California Institute for Technology

Cardiovascular

Relating to the heart and blood vessels

CARF

Commission of Accredited Rehabilitation

Facilities

Conformité Européene (European medical

device certification)

Cervical

Relating to the neck or located around the

neck area

CEO

Chief Executive Officer

DCGC

The Dutch corporate governance code

issued on 8 December 2016

Chairperson

The Chairperson of the Board

CHUV

Centre Hospitalier Universitaire Vaudois

CRO

Contract research organizations

CSO

Chief Scientific Officer

DAPA

Distribution and Pricing Agreement

DARPA

The US Department of Defense Advanced

Research Projects Agency

DCC

Dutch Civil Code

DoD

U.S. Department of Defense

DME

Durable Medical Equipment

EBITDA

Earnings before interest, tax, depreciation

and amortization

ECAT

Electronic Catalog Contract

EEA

European Economic Area

EPFL

École Polytechnique Fédérale de Lausanne

Epidural

Placed or administered outside the dura

mater

European Patent

ESEF

European Single Electronic Reporting

Format

European Union

FDA

U.S. Food and Drug Administration

FDCA

U.S. Federal Food, Drug, and Cosmetic Act

Other Information

365

ONWARD

Medical Annual Report 2025

FSS

U.S. Federal Supply Schedule

FTE

Full time equivalent personnel

GCP

Good Clinical Practice

GDPR

General Data Protection Regulation

GKV

Gesetzliche Krankenversicherung or GKV

System (Public System)

GSA

General Services Administration

HCPCS

Healthcare Common Procedures Coding

System

HDE

Hilfsmittelverzeichnis

HIPAA

Health

Insurance

Portability

and

Accountability Act

HMV

Hilfsmittelverzeichnis

Hours

Hypertension

Higher blood pressure than normal range

Hypotension

Lower blood pressure than normal range

IAS

International Accounting Standards

ICD

International Classification of Diseases

IFRS

International Financial Reporting Standards

IFRIC

IFRS Interpretations Committee

IPG

Implantable pulse generator

Thousands

KPI

Key performance indicator

Lesion

A damaged region in the body

LTIP

Long-Term Incentive Plan

Lumbar

Relating to the lumbar region of the back

Millions

MDR

Medical Device Regulation

Medical Devices Regulation

Regulation (EU) 2017/745

MHRA

Medicines and Healthcare products

Regulatory Agency (UK)

Neurodegenerative

Characterized by the degeneration of

the nervous system

Neuromodulation

Field of bioengineering implicating

technologies impacting neural interfaces

Neuroprosthetic

Device used to restore function in the

body via the interface of electrodes and

the nervous system

Neurostimulation

Application of an electrical stimulation

inducing modulation or activation of the

nervous system for a therapeutic effect

Neurorehabilitation

Training to restore function after an injury or

neurological disorder

NHS

National Health Service (UK)

OPS

Procedure codes

Orthostatic hypotension

Hypotension tied to posture or postural

changes

Paraplegic

Someone affected by paralysis (partial or

complete) of the lower half of the body due

to an injury or disease of the spinal cord

PBS

Public Broadcasting System (U.S.)

Perfusion

Passage of a fluid (blood, water) through

blood vessels, tissue or organ

PMA

U.S. FDA Pre-market approval

Other Information

367

ONWARD

Medical Annual Report 2025

QSR

Quality System Regulations

Reeve Foundation

Christopher and Dana Reeve Foundation

RVO

Rijksdienst voor Ondernemend Nederland

Scaffold (cellular)

Scaffolds engineered to induce cellular

interactions contributing to the formation

of new functional tissues

SCI

Spinal Cord Injury – damage to the nerves in

the spine that circulate signals from the brain

to and from the body. It can be caused by a

trauma or a disease. This damage can lead

to temporary or permanent dysfunctions

SCS

Spinal cord stimulation

SDVOSB

Service-disabled veteran-owned small

business

Spasticity

Abnormal increase in muscle tone usually

caused by nerve damage and can be

associated with pain

STIMO

STImulation Movement Overground (title of

clinical study)

Tetraplegic (Quadriplegic)

Someone affected by paralysis (partial or

complete) of upper and lower limbs due to

injury or disease of the spinal cord

Thoracic

Related to the thoracic region of the back

Transcutaneous

Penetrating through the skin. For example:

transcutaneous stimulation is stimulation

delivered through the skin via electrodes

placed on the skin

UCLA

University of California, Los Angeles

Up-LIFT

Pivotal study to evaluate the Company’s

ARC

Therapy

United States

USD

US Dollar

Vascular

Relating to blood vessels

Zusatzentgelte

Other Information

Relationships	Order	Preferred Label	Label Role	Doc	Period Type	Balance	Type	Reference
{{presentation.Name}}	{{presentation.Order}}	{{presentation.Label}} {{presentation.SecondaryLabel}}	{{presentation.PreferredLabel}}		{{presentation.PeriodType}}	{{presentation.Balance}}
No presentation is available

Relationships	Calculation	Weight	Order	Standard Label	Doc	Period Type	Balance	Type	Reference
{{calculation.Name}}	View	{{calculation.Weight}}	{{calculation.Order}}	{{calculation.Label}} {{calculation.SecondaryLabel}}		{{calculation.PeriodType}}	{{calculation.Balance}}
No calculation is available

Relationships	Status	Order	Standard Label	Doc	Period Type	Balance	Type	Reference
{{definition.Name}}	WiderNarrower	{{definition.Order}}	{{definition.Label}} {{definition.SecondaryLabel}}		{{definition.PeriodType}}	{{definition.Balance}}
No anchor element is available

Prefix	Status	Element Name	DataType	Label
{{tag.Prefix}}	{{tag.IsUsed ? "Used" : "Unused"}}	{{tag.Sequence}} {{tag.Identifier}} {{tag.ElementName}}	{{tag.Datatype}}	{{tag.LabelText}}
No mandatory tag is available

ELEMENT NAME	{{period}}
{{calculationSummary.elementName}}	{{calculationSummary.periodValues[$index]}}
{{childElement.childElementName}}	{{childElement.periodValues[$index]}}
CALCULATED	{{calculationSummary.periodValues[$index]}}
DIFFERENCE	{{calculationSummary.periodValues[$index]}}

Fact Report
Category	Count
Facts	{{documentDetail.FactCount}}
Standard Elements	{{documentDetail.TotalStandardElement}}
Extended Elements	{{documentDetail.TotalExtendedElement}}

Text-Block Report
Category	Count
1. Text and Text-block tags used	{{texblockMetrics.TotalTextblock}}
2. Annex II (Mandatory) 2.a. Text-block tags 2.b. Non-Text-block tags	{{texblockMetrics.TotalMandatory}} {{texblockMetrics.TotalTextblockMandatory}} {{texblockMetrics.TotalNonTextblockMandatory}}
3. Annex IV (Voluntary) 3.a. Text-block tags 3.b. Non-Text-block tags	{{texblockMetrics.TotalNonMandatory}} {{texblockMetrics.TotalTextblockVoluntary}} {{texblockMetrics.TotalNonTextblockVoluntary}}
4. Extended (Voluntary)	{{texblockMetrics.TotalExtendedTextblock}}
5. Unused Annex II (Mandatory) Text-blocks	{{texblockMetrics.TotalUnusedTextblock}}