Ondine Biomedical INC.
Ondine Biomedical Inc. (LON:OBI) is a Canadian life sciences company developing and commercialising light-activated antimicrobial (photodisinfection, aPDT) therapies to prevent and treat healthcare-associated infections, including those caused by multidrug-resistant microbes, without contributing to antibiotic resistance. Its lead commercial product, Steriwave, is a nasal photodisinfection device used mainly for presurgical infection prevention, sold alongside a pipeline of additional indications (burns, chronic wounds, ICU, VAP, CLABSI, CAUTI). The Company's central 2025 priority was completing the pivotal U.S. LANTERN Phase 3 trial ahead of a planned FDA submission.
5 annual reports read, FY2021 to FY2025
Open a year to see what its report said. Every line in it carries the page it was read from.
Sources: Company website (5)
FY2026Next report expected 23 May 2027
- Open the reportJSONComing soonSixty seconds on the FY2025 report
Ondine Biomedical Inc. makes light-based treatments that kill germs to prevent hospital infections, led by a nasal device called Steriwave. Revenue was CAD 2.6m, up from CAD 2.0m (+29.1%), thanks to new hospitals and more use in existing ones. But the loss widened to CAD 29.5m from CAD 19.1m. The bigger loss came mainly from research spending, which more than doubled. Most of it went on LANTERN, a large final-stage US trial needed to win approval from the US regulator, the FDA. Office and administration costs fell. The company ended the year with CAD 10.6m of cash and no bank borrowings, after raising CAD 26.0m by selling new shares. The report mentions no dividend. After the year end it raised a further £5.0 million. Management called 2026 a "defining year", with trial results expected in spring 2026 and an FDA application to follow. The auditor warned of real doubt over whether the company can keep going, given its history of losses and its need for more funding.
From the reportevery line sits on the page it namesWhat drove revenueNew hospital deployments and increased utilisation within existing accounts
Revenue increased by 29% to $2.6 million (2024: $2.0 million), driven by new hospital deployments and increased utilisation within existing accounts.
page 18AndLand-and-expand commercial model across geographies, hospitals/specialties and new clinical use cases
Commercial adoption driven by a disciplined land-and-expand model; expansion into additional areas, hospitals/regions and use cases; total year-end hospital deployments grew from 5 (2021) to 37 (2025)
page 13What moved the marginheadwindGross margin modest decline (61% vs 64% in 2024) due to hardware segment mix
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.
page 18AndtailwindConsumables margin improvement from next-generation Nasal Illuminator rollout in Canada
Consumable's margins improved during the year following the rollout of the Company's next-generation Nasal Illuminator in Canada.
page 18What management saidWith 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... including completing the clinical study report, finalising the remaining components of our planned New Drug Application to the FDA.
page 8After the year endFrom January 6, 2026 to May 21, 2026, the Company entered into agreements for contract services for a scope of work of $1,177 thousand related to clinical services.
page 64Going concern and the auditPwC (Vancouver) issued an unqualified opinion that the consolidated financial statements present fairly the Company's financial position, but included a 'Material uncertainty related to going concern' paragraph referring to Note 1, noting the Company's history of significant losses, accumulated deficit of $314,949 thousand, and dependence on raising further financing; the opinion was not modified in respect of this matter. The sole key audit matter identified was revenue recognition (judgment over distinct performance obligations for laser hardware vs. consumable kits).
page 40The risks it names first- Financial and going concern risk — insufficient cash flow/capital to meet working capital needs, pursue growth, or avoid shareholder dilution from further equity raises.p.19
- Personnel risk — inability to attract and retain key talent/executives, and team collaboration/communication challenges as the Company grows.p.19
- Breach of regulatory and legal requirements — failure to comply with local regulations (FDA, EU MDR, Canadian medical device regulations) could lead to fines, recalls, reputational damage, or delays to market access.p.20
- Clinical trial risk — undesirable/unexpected trial outcomes, recruitment delays and cost overruns, data protection/security risk in managing large clinical datasets.p.20
Read from C000940-AR-2025-website.
- FY2022Year to 31 Dec 2022 Opens with a free accountThe report, its reading and its figures
- FY2021Year to 31 Dec 2021 Opens with a free accountThe report, its reading and its figures