2026 Interim Results & Post-Period Momentum

Ondine Biomedical Inc.

30 September 2026

 

This Announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation No. 596/2014 as it forms part of UK law by virtue of the European Union (Withdrawal) Act 2018 as amended. Upon the publication of this Announcement, this inside information is now considered to be in the public domain.

30 September 2026

ONDINE BIOMEDICAL INC.

(“Ondine Biomedical”, “Ondine”, or the “Company”)

Ondine Biomedical Reports H1 2026 Results Following Positive Phase 3 Topline Readout and Continued Commercial Progress

Positive Phase 3 topline results, peer-reviewed clinical evidence, revenue growth and expanding authorised-market adoption highlight continued clinical and commercial progress.

Ondine Biomedical Inc. (AIM: OBI), a leader in light-activated antimicrobial therapies designed to prevent hospital infections, announces its unaudited financial and operational results for the six months ended 30 June 2026 (“H1 2026”) together with an operational update on post-period activity, including positive topline results from the Company’s LANTERN Phase 3 trial and continued commercial progress in markets where Steriwave is already authorised.

All figures are in Canadian dollars unless otherwise stated.

Key Highlights, including post-period activity

• Positive Phase 3 topline results: The large, multi-centre pivotal Phase 3 clinical trial (LANTERN), in which 5,188 patients were enrolled, met its primary efficacy endpoint. The primary Bayesian analysis demonstrated a 40.5% relative reduction in the risk of 30-day surgical site infection, with a 98.2% posterior probability of benefit, compared with standard of care alone (under which a mupirocin nasal antibiotic regimen was permitted). Three exploratory frequentist analyses were consistent with the primary finding (ORs: 0.47 - 0.48; 95% CIs: 0.25 - 0.88; p-values: 0.016 - 0.022). No treatment-related serious adverse events were identified in the topline analysis. Full analysis is ongoing.
• U.S. regulatory next steps: Following LANTERN's positive topline results, the Company is targeting a pre-NDA meeting with the FDA in Q1 2027 and submission of its New Drug Application (“NDA”) in mid 2027. These are targets and remain subject to completion of the full analysis, preparation of the submission package, securing the necessary funding and ongoing regulatory engagement.
• Commercial progress in authorised markets: Ondine advanced targeted commercial activity in markets where Steriwave is already authorised, with Steriwave deployments and pilots progressing in Canada, the UK and Mexico. Recent milestones included Steriwave’s first Scottish hospital deployment at NHS Golden Jubilee, a commercial, multi-centre pilot with Hospital Ángeles Health System (Mexico’s largest private hospital network), and expansion into additional hospitals in Ontario, Canada’s most populous province.
• Advancing ICU: The SMURF ICU feasibility study, published in Critical Care, showed Steriwave was associated with a significant reduction in early cumulative nasal microbial burden, with an exploratory analysis observing a 39.5% reduction in VAP/HAP pneumonia. Building on this critical care evidence, Ondine announced a strategic research collaboration with Mela Solutions, whose Medicus platform is used across 90% of NHS ICUs, to support data-driven evaluation of Steriwave’s workflow integration, infection impact, capacity utilisation and potential financial returns across NHS intensive care settings.
• Skull-base surgery (Leeds): In a 200-patient before-and-after single-centre service evaluation study in high-risk endoscopic endonasal skull-base surgery at Leeds General Infirmary (Leeds Teaching Hospitals NHS Trust), Steriwave was associated with a 78% relative reduction in surgical site infection risk compared with the preceding mupirocin-based period (p=0.0059). The study results were published under the title “Steriwave® a Non-Antibiotic Nasal Photodisinfection Strategy Reduces Infection Burden in Endoscopic Skull Base Surgery”.
• Peer-reviewed evidence and clinical engagement: Ondine presented Steriwave data through peer-reviewed publications, seven conference presentations and clinical engagement.

Financial Highlights

• Revenue growth with stable commercial spend: Revenue increased 23% to $1.25 million in H1 2026 (H1 2025: $1.01 million), driven by increased utilisation within existing accounts and new hospital deployments, while sales and marketing expenses were held flat at $0.6 million. Gross margin remained stable at 65%.
• Phase 3 investment: Research and development (“R&D”) costs increased to $11.5 million (H1 2025: $8.0 million), driven by investment in the LANTERN trial, the primary driver of the increase in operating loss to $15.9 million (H1 2025: $12.5 million). Following completion of recruitment and the positive post-period topline readout, the Company expects R&D spend, operating loss and cash burn, to reduce materially as activity shifts toward full analysis, regulatory engagement and submission preparation.
• Operational and production capacity investment: The Company has completed investments in its in-house production capabilities to enable it to substantially ramp up sales volumes without further material capacity-related investment.
• Capital raised: The Company raised approximately $9.2 million in strategic investment in April 2026 to support the LANTERN Trial and the NDA preparation and related regulatory, production and operational activities.

Chief Executive Officer's Statement

The first half of 2026 marked a significant step forward for Ondine, centred on completing the clinical execution of the LANTERN Phase 3 trial in support of our pathway to U.S. regulatory approval. Alongside this major clinical undertaking, we continued to advance the business more broadly, delivering revenue growth while holding sales and marketing expenditure stable and maintaining gross margin.

The LANTERN Phase 3 trial enrolled 5,188 patients and met its primary efficacy endpoint, marking an important milestone for our non-antibiotic approach to infection prevention. Following the positive topline readout, we are completing the full analysis and preparing the results for presentation and publication. We plan to engage with the FDA through a pre-NDA meeting targeted for Q1 2027, followed by a U.S. NDA submission targeted for mid 2027, subject to completion of the full analysis, preparation of the submission package, securing the necessary funding and ongoing regulatory engagement. As a large, superiority-designed, cluster-randomised controlled trial, LANTERN represents a rigorous assessment of nasal photodisinfection and adds to its clinical evidence base. Once published, Ondine plans to discuss the detailed findings with hospitals and commercial partners in markets where Steriwave is already authorised.

Other clinical studies of Steriwave in different settings are also reporting results; these are separate from LANTERN and differ in design, population and endpoints. Leeds data published in June in The Journal of Laryngology & Otology reported a 78% relative reduction in surgical site infections compared with mupirocin-based standard of care in high-risk, complex skull-base surgery (p=0.0059). The SMURF feasibility study, published in April in Critical Care, reported a significant reduction in nasal microbial burden as well as an exploratory 39.5% reduction in pneumonia rate, supporting further evaluation of nasal photodisinfection in intensive care. Results from other clinical pilot sites are expected over the coming quarters, contributing to a growing body of abstracts and publications on nasal photodisinfection as an approach to reducing hospital-acquired infection rates.

We are also increasing the visibility of this evidence among clinicians and healthcare leaders. Steriwave data and clinical experience were featured through numerous conference presentations during and post-period, including IPC 2026 (Birmingham), 10th World Congress of Infectious Diseases (Barcelona), RCN International Nursing Research Conference (Glasgow), CSRT 2026 (Whistler), ENDOAthens, and CACCN 2026.

Commercial adoption is progressing in markets where Steriwave is already authorised. Recent milestones include Steriwave’s first deployment in a Scottish hospital at NHS Golden Jubilee (the NHS’s largest hip and knee surgery centre), expansion into additional Ontario hospitals (Canada’s largest provincial market), and a commercial, multi-centre pilot with Hospital Ángeles Health System (Mexico’s largest private hospital network with 27 hospitals).

In the UK, our newly announced strategic data collaboration with Mela Solutions gives Ondine a data-driven pathway to support NHS ICU evaluation of Steriwave, enabling participating Trusts to assess workflow fit, infection impact, capacity utilisation and potential financial returns using their own historical ICU data. This strengthens our ability to convert clinical interest into evidence-based adoption in a substantial critical care market. 

Together these advances reflect our targeted land-and-expand strategy: establish Steriwave in high-value clinical pathways, build clinical experience and advocacy, and support broader adoption across hospital sites, networks and patient populations, consistent with authorised intended use in each market.

Outlook

We approach the remainder of 2026 with clear priorities. Per our previous plan, our immediate priority post LANTERN completion and topline release is securing the funding required to execute the next phase of our strategy. Subject to that funding, we intend to place greater emphasis on commercial activity in authorised markets while continuing to advance the U.S. NDA pathway.

Our focus for the remainder of 2026 and into 2027 include completing and publishing the LANTERN analyses, advancing U.S. regulatory engagement, progressing commercial pilots to broader deployments, deepening adoption in authorised markets, and preparing the operational capacity needed to support higher consumables volumes as adoption increases.

As healthcare systems worldwide seek effective ways to reduce infections, preserve capacity and address antimicrobial resistance, we believe Ondine is well placed to contribute to these priorities while creating sustainable value for patients, hospitals and shareholders.

H1 2026 Financial Overview

• Revenue: increased by 23% to $1.25 million (H1 2025: $1.01 million), reflecting new hospital deployments and increased utilisation within existing accounts.
• Gross margin: stable at 65% (H1 2025: 65%). Subject to completion of the applicable regulatory and quality-system requirements, the planned commercial deployment of the Company’s in-house assembled Formulation Applicator in early 2027 is expected to support improved consumables margins as volumes grow.
• Research and development: increased to $11.5 million (H1 2025: $8.0 million), with the majority of spend related to the LANTERN trial. Cumulative direct trial and related LANTERN costs booked across the programme total approximately $27 million, or approximately $5,000 per patient enrolled. The Company is still processing and reconciling the final clinical trial costs, and has taken a conservative approach to the accounting of these expenses.
• General and administrative: stable at $4.4 million (H1 2025: $4.4 million), reflecting ongoing cost discipline and operational efficiency.
• Sales and marketing: stable at $0.6 million (H1 2025: $0.6 million), with commercial resources focused during the period on supporting clinical programmes, hospital onboarding and distributor market development. Following LANTERN topline read-out, resources are refocusing increasingly on commercial growth in markets where Steriwave is authorised.
• Operating loss: increased to $15.9 million (H1 2025: $12.5 million), reflecting investment in the LANTERN Phase 3 pivotal study. With LANTERN recruitment and follow-up now complete, the Company expects annual operating expenses to reduce materially, predominantly driven by a significant decline in R&D spend, although the timing and extent of any reduction will depend on regulatory, financing, commercial and operational requirements.
• Net loss: increased to $16.2 million (H1 2025: $12.6 million).
• Net cash used in operating activities: $13.3 million (H1 2025: $10.2 million).
• Cash and cash equivalents: decreased to $5.3 million as at 30 June 2026 (31 December 2025: $10.6 million), reflecting LANTERN trial expenditure, partly offset by the approximately $9.2 million raised in May 2026.

The Company's current cash position is expected to fund operations into mid-Q4 2026, an extension on the guidance provided at the time of its Spring 2026 fundraise. The Company therefore needs to secure additional funding in the near term and is today announcing the commencement of an equity fund raising process. The proceeds are expected to be applied towards publishing the full LANTERN trial analyses, advancing FDA engagement with the intention of submitting the NDA in mid-2027, as well as progressing commercial pilots and investing further in sales and marketing to broaden product deployments and deepen adoption in markets where Steriwave is already authorised, whilst also having access to additional working capital to fund growth. Finally, the Company plans to continue to enhance and strengthen the capabilities of the Board and its senior management team as the Company’s focus shifts to the critical next stage of its growth journey. 

The unaudited interim financial statements can be found here http://www.rns-pdf.londonstockexchange.com/rns/8605W_1-2026-9-29.pdf and are also being made available on the Company's website at: www.ondinebio.com/investors/reports-documentation/ 

Investor Presentation

Ondine expects to host a presentation to all existing and potential shareholders following the conclusion of the equity fundraise process. A further announcement will be issued at that time.

Enquiries:

Ondine Biomedical Inc.	www.ondinebio.com
Carolyn Cross, CEO	[phone] or via 5654 & Company
Strand Hanson Limited (Nominated & Joint Financial Adviser)
James Harris, Richard Johnson, Imogen Ellis	[phone]
Peel Hunt LLP (Broker & Joint Financial Adviser)
James Steel, Dr. Chris Golden	[phone]
5654 & Company (Financial PR and IR Adviser)	[e-mail]
Matthew Neal, Chris Gardner, Melissa Gardiner, Lucy Featherstone	[phone] [phone] [phone]

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, branded as Steriwave® outside the United States, is authorised for nasal decolonisation in Canada, the UK, and certain other international markets. 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.

Regulatory approvals, clearances and authorisations vary by jurisdiction, and indications, claims and availability may differ between markets. No statement in this announcement should be interpreted as representing approval, clearance, authorisation or availability in any jurisdiction, or for any use, where such status has not been granted.

U.S. Regulatory Status and Clinical Data Disclaimer

Ondine’s nasal photodisinfection technology is not approved by FDA and is not commercially available for sale in the United States. In the United States, it is limited by federal law to investigational use only.

References to clinical outcomes in this release should be interpreted in the context of the specific studies, endpoints, patient populations or real-world evaluations described and do not imply regulatory approval for any particular indication or jurisdiction.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements regarding clinical development, regulatory activities and approvals, commercial adoption, manufacturing and operational scale-up, future expenditure 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, among others, clinical trial outcomes and interpretation, completion of the full LANTERN analysis, regulatory engagement and decisions, the timing and acceptance of any NDA submission, the availability of financing and the Company's ability to continue as a going concern, manufacturing and supply-chain readiness, commercial adoption, reimbursement and market-access considerations, and competitive developments. 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.

 

END