Ondine Biomedical (OBI) investor relations material

Executive summary

• Achieved significant clinical, regulatory, and commercial progress, including completion of the pivotal LANTERN Phase 3 U.S. trial and expansion in Canada, UK, Europe, and other international markets, with hospital deployments up 28% year-over-year.

• Focused on infection control through photodisinfection, targeting healthcare-associated and drug-resistant infections, and building foundations for long-term growth and U.S. market entry.

• Preparing for U.S. regulatory submission and commercial readiness in priority markets, with top-line Phase 3 results expected by Spring 2026.

• Expanded real-world evidence and customer base, with strong results in infection reduction and significant cost savings for hospitals.

Financial highlights

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

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

• R&D investment surged to $21.2 million CAD (from $9.2 million), mainly for the Phase 3 trial, representing the majority of operating spend.

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

• Raised over $24 million CAD during the year, with an additional $8.6–9 million post-year-end, extending cash runway into Q4 2026.

Outlook and guidance

• Top-line Phase 3 results expected in Spring 2026, with NDA submission to FDA and commercial rollout in the U.S. anticipated soon after approval.

• Continued expansion in Europe and other international markets through strategic partnerships and pilots.

• Majority of development and regulatory costs are already behind, with future fundraising decisions to be informed by Phase 3 results.

• Focused on building adoption across priority markets and preparing for future demand and operational scale-up.