Ondine Biomedical (OBI) investor relations material

Executive summary

• Advanced a novel light-activated antimicrobial platform, completing the pivotal LANTERN Phase 3 U.S. clinical trial with top-line results expected by Spring 2026, and expanded commercialization in Canada, the U.K., Europe, and pilot markets.

• Focused on infection control through photodisinfection, targeting healthcare-associated and drug-resistant infections, with real-world data showing significant reductions in surgical site infections and hospital stays.

• Strategic resource allocation prioritized clinical evidence generation, especially the large phase III trial, ICU pilot, and hospital pilots to support regulatory and commercial expansion.

• Preparing for U.S. regulatory submission and commercial readiness, with operational scale-up and manufacturing underway.

• Achieved a 28% increase in hospital deployments and collaborations, expanding the facility footprint and adoption across multiple geographies and specialties.

Financial highlights

• Revenue increased 29% year-over-year to CAD 2.6 million, driven by new hospital deployments and increased utilization.

• Gross profit rose 22% to CAD 1.6 million, with gross margin between 61% and 64%, impacted by hardware investments but improved consumables margin.

• R&D investment surged to CAD 21.2 million (from CAD 9.2 million), with the majority allocated to the phase III trial.

• Operating expenses totaled CAD 31.6 million, resulting in a net loss of CAD 29.5 million and operating loss of $30 million.

• Raised approximately CAD 24 million during 2025, with an additional CAD 8.6–9 million post-year-end to support ongoing priorities.

Outlook and guidance

• Top-line phase III results expected in Spring 2026, with NDA submission and FDA engagement targeted for the fall and commercial rollout in the U.S. anticipated soon after approval.

• Manufacturing scale-up and operational readiness underway to meet expected demand and support sustainable growth.

• Expansion into broader hospital use, ICU, and new indications planned, leveraging the platform's versatility.