2025 Full Year Results and Annual Report
Summary by AI BETAClose X
4 June 2026
ONDINE BIOMEDICAL INC.
("Ondine Biomedical", "Ondine", or "the Company")
2025 Full Year Results and Annual Report
Near-term Phase 3 pivotal study read out; growing international real-world evidence and commercial traction
Ondine Biomedical Inc. (AIM: OBI), a global leader in light-activated antimicrobial therapies to prevent and treat hospital infections, announces its audited financial and operational results for year ended 31 December 2025.
Operational Highlights (including post-period end)
Clinical progress
· Completed patient enrolment in the LANTERN Phase 3 pivotal U.S. clinical trial across 14 HCA Healthcare Hospitals in the United States and four Canadian centres. Subject to receipt of final data, top-line results are expected by the end of Spring 2026.
· Continued preparations for planned FDA regulatory submissions and commercial-scale manufacturing readiness following completion of patient enrolment in the LANTERN study.
· Reported excellent feasibility pilot study results from the intensive care unit ("ICU") at Royal Columbian Hospital, demonstrating feasible and safe implementation of Steriwave in the ICU, significant reduction in nasal pathogen burden (p<0.01), alongside a 39.5% reduction in observed pneumonia rates. The results were published in peer-reviewed publication Critical Care.
Real-world evidence, healthcare economics and commercial progress
· Expanded international real-world clinical use with deployments, pilot programmes, and clinical collaborations increasing 28% year-on-year to 37 hospitals and surgical clinics:
o Canada: expanded adoption across major Canadian healthcare institutions, including the University of Ottawa Heart Institute adopting Steriwave as standard of care for all cardiac surgeries, Interior Health becoming the second health authority in British Columbia to standardise Steriwave for hip and knee replacement surgeries, and continued deployment growth across Fraser Health hospitals and leading cardiac and surgical centres.
o UK: initiated a Steriwave pilot at Royal Papworth Hospital NHS Foundation Trust, one of the world's leading cardiothoracic centres, while continuing to leverage NHS Supply Chain access to support streamlined procurement pathways across England and Wales.
o Europe: established clinical collaborations and pilot programmes in Switzerland, Germany and Spain, including studies evaluating Steriwave in preoperative nasal decolonisation and ENT surgery pathways.
o Rest of World: launched the first Steriwave pilot in Mexico at ABC Medical Center and continued to advance international opportunities, including an Australian pilot evaluating Steriwave to reduce infection risk in oncology patients.
· Reported real-world infection reduction data observed at leading orthopaedic and spine surgery centres that compared infection rates before and after introducing Steriwave®:
o Mid Yorkshire Teaching NHS Trust: Steriwave implementation was associated with a 71% reduction in knee and hip arthroplasty surgical infections compared with another topical nasal antimicrobial agent.
o Sherbrooke University Hospital, Quebec: Steriwave was associated with a 78% reduction in spine surgery surgical site infections and a 30% reduction in average hospital length of stay.
Real-world findings are based on observational studies and may be influenced by multiple factors.
· A study published by the York Health Economics Consortium (YHEC) found that using Steriwave prior to major surgery delivers substantial net cost savings with potential savings to the NHS of £1.49 to £2.38 for every £1 spent on Steriwave across major surgeries.
Financial Highlights (including post-period end)
Financials (all figures in Canadian dollars)
· Revenues increased by 29% to $2.6 million (2024: $2.0 million), driven by new hospital deployments and increased utilisation within existing accounts.
· Gross margin was 61% (2024: 64%) with the modest change year-on-year primarily reflecting the Company's hardware segment, where strategic investments continue to support customer adoption and market penetration. Consumables margins improved during the year following the rollout of the next-generation Nasal Illuminator in Canada.
· Operating loss was $30 million (2024: $19.4 million), reflecting increased investment in clinical evidence generation, including conducting the U.S. Phase 3 pivotal study, FDA audit readiness, and operational infrastructure to support future growth.
Fundraising
· Successfully secured approximately $5 million in strategic investment in January 2025, followed by a further c.$19 million in net proceeds from a fundraising announced in August 2025.
· Post period-end, successfully completed a further c.$9.2 million gross proceeds fundraising through a placing and subscription.
Carolyn Cross, CEO of Ondine Biomedical, commented:
"Ondine has used the past year to build with discipline and conviction. Completion of patient enrolment in our pivotal LANTERN Phase 3 study, marks a significant milestone in our strategy to bring nasal photodisinfection to the U.S market. Alongside the trial, our growing body of real-world evidence continues to demonstrate the potential of Steriwave to reduce infections, improve patient outcomes and lower healthcare costs.
"With the continued support of our shareholders, we have strengthened our financial position and taken significant steps towards scaling our manufacturing capabilities and advancing our FDA submission activities. Looking ahead, 2026 is expected to be an important year for Ondine as we focus on delivering the LANTERN clinical results, progressing our regulatory plans and continuing to execute our growth strategy. We believe the progress achieved clinically, commercially, financially and operationally over the past year positions the Company to deliver sustainable growth and long-term value for shareholders."
Presentation and Live Q&A
Dr. Nicolas Loebel, President and Chief Technology Officer, and Alan Thomas, Chief Financial Officer, will host a presentation and live Q&A session relating to the Full Year Results at 16:30 BST (08:30 Pacific time). The presentation is open to all existing and potential shareholders.
Questions can be submitted pre-event via your Investor Meet Company dashboard at any time before or during the presentation.
The recording and related slides will be made available after the presentation on the Company's website: www.ondinebio.com/investors/reports-documentation/.
Annual Report and AGM
A complete version of the 2025 Annual Report and Accounts ("2025 Annual Report") can be found here: http://www.rns-pdf.londonstockexchange.com/rns/9123G_1-2026-6-3.pdf and is also being made available to shareholders on the Company's website at www.ondinebio.com/investors/reports-documentation/.
The AGM will be held at 4:00 p.m. BST (8:00 a.m. Pacific Time) on 30 June 2026. The Notice of AGM and Proxy Form are available on the Company's website.
All figures are expressed in Canadian Dollars, unless otherwise stated.
Enquiries:
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Ondine Biomedical Inc. |
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Carolyn Cross, CEO |
+1 604 669 0555 |
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Strand Hanson Limited (Nominated & Joint Financial Adviser) |
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James Harris, Richard Johnson |
+44 (0)20 7409 3494 |
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Peel Hunt LLP (Broker & Joint Financial Adviser) |
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James Steel, Dr. Chris Golden |
+44 (0)20 7418 8900 |
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5654 & Company (Financial PR and IR Adviser) |
ondinebiomedical@5654.co.uk |
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Matthew Neal, Chris Gardner, Melissa Gardiner |
+44 0791 7800 011 +44 0775 7697 357 |
About Ondine Biomedical Inc.
Ondine Biomedical Inc. is a Canadian life sciences company focused on the development of light-activated antimicrobial therapies ('photodisinfection') for the prevention and treatment of infections, including those associated with multidrug-resistant organisms.
Ondine's lead product, Steriwave®, is authorized for nasal decolonisation in Canada and certain international markets. In the United States, the technology has been granted Qualified Infectious Disease Product designation and Fast Track status by the U.S. Food and Drug Administration and recently completed enrolment in its Phase 3 clinical trial.
The Company has a pipeline of additional photodisinfection products in various stages of development for application in areas including chronic sinusitis, ventilator-associated pneumonia, burns and other indications.
U.S. Regulatory Status and Clinical Data Disclaimer
Ondine's light-activated antimicrobial technology, commercially available as Steriwave® in certain jurisdictions, is not approved, cleared, or commercially available for sale or clinical use in the United States and is limited by U.S. law to investigational use only.
References to clinical outcomes in this release should be interpreted in the context of the specific studies or real-world evaluations described and do not imply regulatory approval for any particular indication.
Forward-Looking Statements
This announcement contains forward-looking statements, including statements regarding clinical development, regulatory approvals, and potential indications for the Company's technology. These statements are based on current expectations and are subject to risks and uncertainties that may cause actual results to differ materially.
Such risks include clinical trial outcomes, regulatory decisions, and commercial factors. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this announcement. The Company undertakes no obligation to update them except as required by applicable law, including the AIM Rules for Companies and UK Market Abuse Regulation.
Chairman's Statement: Foundations for a Pivotal Year
In 2025, Ondine Biomedical continued to advance its long-term strategy of redefining infection prevention through non-antibiotic solutions. Healthcare-associated infections remain one of the most persistent and costly challenges facing global healthcare systems, compounded by the accelerating impact of antimicrobial resistance. Against this backdrop, the need for effective, scalable alternatives to traditional approaches has never been greater.
Ondine is focused on establishing photodisinfection as a foundational technology in infection prevention. Our light-activated, non-resistance-forming approach is designed to align with the evolving priorities of healthcare systems worldwide - improving patient outcomes, increasing surgical capacity, and reducing the economic burden associated with avoidable infections. This positions the Company at the intersection of two powerful drivers of change: the global response to antimicrobial resistance and the growing demand for more efficient, outcome-focused care delivery.
Over the past year, we have continued to build the clinical, regulatory, and commercial foundations necessary to support long-term growth. Our strategy is centred on generating high-quality evidence, engaging with leading institutions, and advancing regulatory pathways in key markets, particularly the United States. At the same time, we are expanding awareness and acceptance of photodisinfection through scientific and clinical engagement, with increasing recognition of its role within modern infection control protocols.
A central pillar of this strategy is the LANTERN Phase 3 pivotal study, conducted across 18 hospitals in two countries and involving more than 5,000 patients. This landmark trial, supported by HCA Healthcare and delivered in partnership with its expert research team, represents a defining moment for the Company. As the world's first nasal photodisinfection-based crossover study, it has been designed to provide the level of evidence required to support regulatory approval and broad clinical adoption in the United States.
With top-line results anticipated in Spring 2026, we are focused on the next phase of our development, including preparation for FDA submission and subsequent commercial expansion. We believe successful completion of this process will not only enable entry into the U.S. market but also serve as a catalyst for wider global adoption and the continued development of Ondine's broader pipeline of photodisinfection applications.
Looking ahead, our priority is to translate our clinical progress into sustainable commercial growth. This includes deepening partnerships with healthcare providers, demonstrating economic value at scale, and ensuring that our technology can be readily integrated into standard clinical practice. As healthcare systems continue to seek solutions that address both clinical outcomes and cost pressures, we are confident that Ondine is well positioned to play a meaningful role in shaping the future of infection prevention.
On behalf of the Board, I would like to thank our management team, partners, and shareholders for their continued commitment and support as we build the foundations for long-term success.
The Honourable Jean Charest
Chairman
4 June 2026
CEO Statement: Preparing for Global Impact
In 2025, Ondine Biomedical maintained a disciplined focus on execution, with a clear objective: to translate our technology and clinical progress into a scalable, high-impact business. We concentrated our efforts on building the clinical and regulatory foundations necessary for U.S. market entry, while at the same time shaping a commercial model designed for sustainable growth and broad adoption.
Healthcare-associated infections remain a major driver of cost and capacity constraints for health systems, with billions of dollars spent each year on preventable complications and their consequences. Each surgery has an embedded "infection tax" of up to $1,000 before lost surgical capacity and quality of life considerations are quantified. Alongside clinical data, we are generating health economic evidence to quantify the potential cost, capacity and patient outcome benefits of nasal photodisinfection compared with current standard of care.
As antimicrobial resistance continues to erode the effectiveness of traditional antibiotics, providers are actively seeking practical, non-antibiotic solutions that can improve outcomes, protect capacity, and support more efficient care delivery. Ondine's photodisinfection platform addresses this need through a light-activated antimicrobial approach that does not rely on antibiotics or generate resistance and can be integrated at critical points in the patient journey. Our real-world results suggest that nasal photodisinfection offers improved outcomes for both patients and healthcare systems.
Our central operational priority in 2025 was the successful execution of the LANTERN Phase 3 pivotal trial, which underpins our U.S. regulatory strategy. Conducted across 18 hospitals in two countries and involving more than 5,000 patients, LANTERN represents the most significant clinical investment in the Company's history. We are deeply grateful to HCA Healthcare and its clinical research group, HRI, for their leadership, expertise, and commitment in managing this large-scale, complex study. We would also like to thank the experienced research teams at the four Canadian hospitals who supported our trial with their expertise and their patient access as well as healthcare system and population diversity. This collaboration has been instrumental in bringing the LANTERN trial to completion.
With top-line LANTERN results anticipated in Spring 2026, our focus is now on ensuring that we are ready to move decisively once data are available. This includes completing the clinical study report, finalising the remaining components of our planned New Drug Application to the U.S. Food and Drug Administration, and aligning our organisation and resources around a clear path to launch, subject to regulatory approval.
In parallel with LANTERN, we continued to broaden the clinical and commercial footprint of Steriwave. Pilot programmes and evaluations across multiple key geographies and care settings are being undertaken selectively to build the right partnerships. Spanning new surgical and distribution pathways as well as early work in high-risk environments such as intensive care, these pilots support our land-and-expand strategy. With this approach, we are integrating direct experience and real-world knowledge to optimise our commercial strategies.
The intensive care unit (ICU) will be an important market for nasal photodisinfection given the 12-15% infection rates in these fragile patients. In 2025, the AIM Royal Columbian Hospital research group successfully conducted and completed the world's first clinical study of nasal photodisinfection in the ICU. This investigator-initiated pilot study demonstrated patient safety and the feasibility of integrating Steriwave into ICU workflows and generated strong evidence of nasal pathogen reduction in critically ill patients, confirming our belief that nasal photodisinfection can significantly improve outcomes in the ICU. The study, now published in Critical Care, also showed an observed reduction in hospital-acquired pneumonia, a leading cause of morbidity, mortality, and cost in critical care settings.
With an expanding set of indications in mind, we deliberately target leading institutions and specific high-value use cases where the clinical and economic impact of infection prevention is most visible. Over time, we work to expand utilisation across additional departments, procedures, and indications as confidence and experience grow. In this way, we hope to expand the network of photodisinfection users to build awareness and regional endorsement.
This pilot-driven approach serves several purposes. It generates real-world evidence that complements our clinical trial data, building confidence among clinicians and administrators. It deepens relationships with hospital partners, creating internal advocates who understand both the clinical impact and operational practicality of photodisinfection. This also establishes initial commercial beachheads from which we can grow sales as health systems see the benefits in reduced complications, increased throughput, and more efficient use of existing infrastructure.
To support this strategy, we have continued to strengthen our operational capabilities. Investments in manufacturing and supply, including enhanced control over key components of our photosensitizer delivery, are intended to support reliable scaling as demand grows. At the same time, we are refining a service-led commercial model that simplifies hospital adoption, emphasising integration into existing workflows, staff training, and data-driven demonstration of value, as we prepare for broader rollout.
While our current installed base and revenue remain at an early-stage relative to the scale of the opportunity, there is significant potential for long-term growth if clinical, regulatory and commercial milestones continue to be achieved. More than 300 million surgical procedures are performed each year worldwide, and infection prevention is an increasingly strategic priority for health systems working to manage cost, capacity, and risk. We believe that a combination of strong clinical data, compelling real-world evidence, and a targeted land-and-expand commercial strategy leveraging our existing hospital and healthcare system relationships can position Ondine to capture a meaningful share of this large and growing market over time. Success with the first photodisinfection application will help to accelerate the commercialization of our other treatment and prevention products in our pipeline.
Looking ahead, 2026 is expected to be a defining year for the Company. Our priorities are clear: deliver the LANTERN clinical results, advance our FDA submission, and build up the operational and commercial capabilities required for launch and subsequent scale-up. We remain committed to disciplined capital allocation, evidence-led decision-making, and a sharp focus on execution.
We would like to thank our dedicated employees and consultants, our numerous clinical partners, and our loyal shareholders for their continued trust and support of our efforts to bring our lifesaving technologies to global healthcare systems. We remain focused on translating our scientific and clinical progress into durable, long-term value for all stakeholders.
Carolyn Cross
Chief Executive Officer
4 June 2026
Our Strategy: Unlocking the Full Potential of Our Proprietary Platform
Foundations for scalable growth
Ondine's strategy is focused on realising the full potential of its proprietary photodisinfection platform across global healthcare markets, starting with Steriwave. Steriwave serves as a strategic entry point into healthcare systems, creating opportunities to expand into additional indications, departments, and future platform applications.
In 2025, we made a deliberate decision to prioritise clinical evidence generation to strengthen the foundation for continued adoption and future expansion, while maintaining targeted commercial activity. This included investment in the LANTERN Phase 3 study, the first ICU feasibility study of Steriwave, and collaborations with leading health care institutions to generate real-world clinical and health economic evidence.
Together, these initiatives strengthened Ondine's clinical, commercial and operational foundations. They support the Company's land-and-expand strategy, help build confidence among clinicians and healthcare administrators, and provide a stronger platform for future growth as Ondine prepares for the next stages of U.S. regulatory engagement, commercial adoption and global scale-up.
Commercial adoption
During 2025 and post-period, Ondine continued to expand its international real-world clinical footprint, with deployments, pilot programmes and clinical collaborations increasing by 28% year-on-year to 37 hospitals and surgical clinics. These sites support workflow integration, local clinical adoption and the generation of real-world evidence for Steriwave.
Our commercial adoption is driven by a disciplined land-and-expand model designed to establish high-credibility footholds with key hospital systems. By targeting initial deployments with clinicians focused on improving patient outcomes, we secure the early-stage evidence and local advocacy required for broader rollout.
Throughout 2025, we concentrated on establishing these strategic beachheads, prioritising workflow integration and evidence generation.
In Canada, adoption expanded across major healthcare institutions, including the University of Ottawa Heart Institute adopting Steriwave as standard of care for all cardiac surgeries, Interior Health becoming the second health authority in British Columbia to standardise Steriwave for hip and knee replacement surgeries, and continued deployment growth across Fraser Health hospitals and other leading cardiac and surgical centres. The technology was also deployed for the first time in an intensive care unit at Royal Columbian Hospital, extending its application beyond traditional surgical pathways.
In the United Kingdom, Steriwave was integrated into cardiac surgical care pathways through a pilot programme at Royal Papworth Hospital NHS Foundation Trust, supported by Ondine's distribution partner Mölnlycke Health Care. The Company also continued to leverage its NHS Supply Chain listing to support streamlined procurement pathways and increase visibility among NHS organisations across England and Wales.
Across Europe, Ondine expanded clinical collaborations and pilot programmes, including an ENT pilot at LMU University Hospital Munich, an independent study at University Hospital Zurich, and deployment supporting ENT surgery pathways in Spain. Beyond these markets, Steriwave was introduced through a first hospital pilot at ABC Medical Center in Mexico City and is being used in oncology patients at The Mater Hospital in Sydney, Australia, further expanding its application across new geographies and patient populations.
The evidence generated during 2025 and post-period further strengthened the case for broader adoption. Independent findings reported significant reductions in surgical site infections across orthopaedic and spine surgery pathways, including a 71% reduction in knee and hip arthroplasty infections at Mid Yorkshire Teaching NHS Trust and a 78% reduction in spine surgical site infections at Université de Sherbrooke with a 30% reduction in average hospital length of stay. In parallel, analysis by the York Health Economics Consortium (YHEC) confirmed that using Steriwave prior to major surgery can deliver substantial net cost savings, with potential savings of £1.49-£2.38 for every £1 invested. Together, this evidence provides further validation of Steriwave's clinical and economic value and support broader adoption by healthcare providers and administrators.
This methodical approach cultivates clinical champions and high-profile reference sites, creating a scalable foundation to expand across new departments, geographies and use cases including expansion to additional areas within the same institution, expansion into additional hospitals and regions, and expansion into new use cases.
Preparation for U.S. market entry
In 2025, Ondine directed the majority of its financial, human, and operational resources to the execution of its LANTERN Phase 3 pivotal study. This large-scale, private/public multicentre cross-over study conducted across two countries represents a significant milestone for Ondine, and is a key component of Ondine's regulatory submission to the U.S. Food and Drug Administration (FDA) for access to the U.S. market.
Patient enrolment in the LANTERN study was completed post-period, with 5,188 patients enrolled across 14 HCA Healthcare hospitals in the United States and four hospitals in Canada. Subject to receipt of final data, the Company remains on track to report top-line results in Spring 2026 and is advancing the activities required to support its planned NDA pathway, including regulatory engagement, and related manufacturing and commercial planning.
Operational readiness and scale-up
Ondine's ability to scale is driven by the deliberate build-out of its operational and organisational infrastructure. In 2025, the Company strengthened manufacturing, supply chain, systems, and talent frameworks to support demand and consistent execution. These foundations enable complex clinical delivery and support transition to large-scale commercial deployment.
During 2025 and post-period, the Company continued to advance its in-house manufacturing capabilities through dedicated equipment, facility upgrades and system improvements, including the installation and validation of automated fill-and-finish equipment to increase capacity, improve production control and support lower cost of goods over time. Ondine also continued to enhance its Quality Management System through the consolidation and digitisation of quality processes, supporting a transition to a predominantly paperless environment by the end of 2026 and improving operational efficiency. In parallel, the Company introduced formal Sales and Operations Planning processes and further strengthened supply chain capabilities to improve demand forecasting, supply alignment and readiness for future global scale-up.
Financial Review
Ondine's financial priorities during 2025 were focused on advancing clinical development, supporting targeted commercial activity, and strengthening operational infrastructure. The Company directed the majority of its investment toward its pivotal Phase 3 clinical trial, reflecting a deliberate emphasis on building clinical validation ahead of key regulatory milestones as a driver of long-term value. During the year, the Company raised c. $24 million to support these clinical priorities with the support of its long-term shareholders and other investors.
In parallel, Ondine made targeted investments in manufacturing and operational infrastructure to support future scalability, including dedicated manufacturing equipment, preparatory work to enable in-house fill-and-finish capability, and upgrades to internal systems to improve production efficiency, quality and supply chain resilience.
This disciplined allocation of capital reflects a clear strategy to prioritise clinical progress and operational readiness, positioning the Company for its next phase of growth as it approaches key clinical and regulatory milestones.
Revenue
Revenue increased by 29% to $2.6 million (2024: $2.0 million), driven by new hospital deployments and increased utilisation within existing accounts. Gross margin was 61% (2024: 64%), with the modest change year-on-year primarily reflecting the Company's hardware segment, where strategic investments continue to support customer adoption and market penetration. Consumable's margins improved during the year following the rollout of the Company's next-generation Nasal Illuminator in Canada.
Research and development expenditure
Research and development expenses totalled $21.2 million (2024: $9.2 million), of which $16.6 million was attributable to the LANTERN Phase 3 clinical trial. The majority of total projected trial costs have been incurred as of 2025, with the study now near completion.
The Company notes that Phase 3 clinical trials in the pharmaceutical industry typically involve per-patient costs in the tens of thousands of dollars and can result in total trial costs in the hundreds of millions for studies of comparable size and scale. The Company's investment demonstrates its ability to execute a large-scale clinical trial with capital significantly below that typically associated with studies of this size.
In addition, the Company completed its first ICU pilot study during the year, demonstrating a significant reduction in nasal bacterial load in critically ill patients. The study was funded through equity-based arrangements, allowing the Company to advance clinical evidence generation while preserving cash resources. The Company also supported clinical and commercial pilot programmes across multiple geographies.
General and administrative expenses
General and administrative expenses decreased by 12% to $8.7 million (2024: $9.9 million), reflecting ongoing efforts to optimise the cost base while maintaining core capabilities.
Marketing and sales expenses
Marketing and sales expenses remained stable at $1.1 million (2024: $1.1 million), reflecting the Company's prioritisation of clinical development over near-term revenue expansion. Commercial activity remained focused on building a foundation for future growth, including expanding the Company's installed base, working closely with distribution partners in early-stage market development, and onboarding and supporting Phase 3 clinical trial sites.
Liquidity, cash and cash equivalents
As at December 31, 2025, the Company held cash of $10.6 million (2024: $9.9 million). Net cash used in operating activities was $23.8 million (2024: $15.5 million), primarily driven by investment in the Phase 3 clinical trial. During the year, the Company secured $24.2 million in financing (2024: $21.7 million), supporting continued operations and strategic priorities.
The Company continues to manage its capital resources carefully, aligning expenditure with strategic priorities and maintaining focus on efficiency and disciplined execution.
Post-period fundraise
Post period, Ondine raised $8.6 million in net cash from a £5.0 million gross fundraise ($9.2 million), with extensive support from existing shareholders.
Alan Thomas
Chief Financial Officer
4 June 2026
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