Ondine Biomed Regulatory News (OBI)

13 April 2026

ONDINE BIOMEDICAL INC.

("Ondine Biomedical", "Ondine", or "the Company")

Business Update

Preparing for next phase of growth

· Clinical Milestones: Completed patient enrolment in the pivotal LANTERN Phase 3 U.S. trial, with results expected in Spring 2026.

· Real-World Evidence Expansion: SSI reduction programmes at top hospitals and real-world evidence growing globally support broader commercial opportunities.

· Revenue Growth and Operational Scale-up: 29% unaudited revenue growth in 2025; in-house manufacturing and facility upgrades underway for larger scale future growth and stronger supply chain control.

Ondine Biomedical Inc. (AIM: OBI), a global leader in light-activated antimicrobial therapies to prevent and treat hospital infections, today provides a business update on its nasal photodisinfection technology, branded as Steriwave® outside the U.S.

Carolyn Cross, CEO of Ondine Biomedical, commented: 

“Ondine Biomedical has recently achieved major milestones in both national and international clinical programmes. The recent completion of enrolment in the LANTERN Phase 3 study, involving 18 hospitals and over 5,000 patients, highlights our capability to operationalise and control complex multinational trials. We've also expanded our evidence base through innovative ICU and SSI pilot projects in Switzerland, Germany and Mexico, showcasing the clinical value of our technology. 

"In parallel, we have made substantial investments in facility upgrades, in-house production automation equipment, and enhanced system processes, ensuring both operational efficacy and resilience. Vertical integration of our manufacturing operations reduces reliance on external subcontractors, and simultaneously allows gross margin enhancement, both critical as we expand our leadership in the prevention and treatment of hospital acquired infections.”

Clinical Progress

Patient enrolment for the LANTERN Phase 3 study, encompassing 14 hospitals in the United States and 4 in Canada, has been successfully completed.  With over 5,000 patients enrolled across two countries, this large-scale, private/public multicentre trial represents a significant milestone for Ondine. The Company is now focused on the next phases of its New Drug Application ("NDA") to FDA, with top-line results due in Spring 2026.

Growing Body of Real-World Evidence

Pilot studies are an important pathway for both clinical validation and early commercial adoption. Last year, the Company expanded into the intensive care setting with a first-of-its-kind deployment of nasal photodisinfection involving patients in a critical care setting at Royal Columbia Hospital (RCH) in British Columbia, Canada.

The RCH ICU pilot study, which was intended to inform a larger clinical trial, demonstrated product safety, ease of workflow, good patient compliance, and an 80% reduction (p<0.05) in opportunistic pathogen carriage of ICU patients. The full manuscript documenting the RCH findings, "Suppression of Microbial Burden to Reduce Pneumonia in Critical Illness: the SMURF Feasibility Pilot Study", has been accepted for publication in the Journal of Critical Care and will soon be available online.

Additional studies, pilots and evaluations are underway across leading institutions internationally, including Royal Papworth Hospital NHS Foundation Trust, University Hospital Zurich, LMU University Hospital in Munich, and additional centres in Spain, Mexico, and Australia. Together, these activities are generating a growing body of clinical and real-world evidence to support broader adoption of Steriwave across multiple clinical settings. Further manuscripts and conference presentations are expected throughout the year.

Commercial Progress

Revenue in 2025 increased by 29% (unaudited), driven by new hospital deployments and increased utilisation within existing accounts.

Building on this expanding body of clinical and real-world evidence, Ondine is progressing commercial adoption through targeted deployments under its 'land and expand' strategy. In Canada, five new hospitals have recently approved implementation with onboarding in Q2 2026, while four major tertiary hospitals were introduced to Steriwave during the LANTERN Study, reflecting continued domestic expansion with a small, dedicated sales team. Programmes in international markets are increasing awareness and supporting evidence generation with key pilots and early-stage adoption through its distributors.

In the UK, Ondine has several hospital and pilot sites deploying nasal photodisinfection. Steriwave also is now classified as an 'Innovation Product' by NHS Supply Chain, increasing visibility among NHS Trusts and procurement teams. Steriwave has been awarded this classification for its alignment with key long-term NHS goals of reducing serious infections, waitlists, healthcare costs and antimicrobial resistance. Ondine's collaboration with Mid Yorkshire Teaching NHS Trust earned the Company and Steriwave finalist and winning recognition across a number of national awards, including the Excellence in Healthcare Partnership Awards, 2026 BioNow Product of the Year, and several HSJ and HSJ Partnership awards.

Operational Readiness and Scale-up

Ondine is investing in its operational infrastructure, expanding production capacity and upgrading facilities to improve production flow, inventory management, cost of goods, and FDA audit readiness. A key initiative is the installation of automation equipment for the in-house production of photosensitizer formulation applicators, providing greater control over quality, cost efficiencies, and strengthening supply chain resilience. These investments are expected to support ongoing sales growth and prepare the Company for further increased demand.

Ondine Biomedical expects to report its 2025 Full Year Results on 21 May 2026.

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About Ondine Biomedical Inc.

Ondine Biomedical Inc. is a Canadian life sciences company and leader in light-activated antimicrobial therapies ('photodisinfection') for the prevention and treatment of infections, including those caused by multidrug-resistant organisms. Ondine has a pipeline of investigational products, based on its proprietary photodisinfection technology, in various stages of development.

Ondine's nasal photodisinfection system is CE-marked in Europe and is approved for nasal decolonisation in Canada, Australia, Mexico, and several other countries under the name Steriwave®. In the US, it has been granted Qualified Infectious Disease Product designation and Fast Track status by the FDA and is currently undergoing clinical trials for regulatory approval. Products beyond nasal photodisinfection include therapies for a variety of medical indications such as chronic sinusitis, ventilator-associated pneumonia, burns, and other indications.