Ondine Biomedical (OBI) H1 2026 earnings summary

Executive summary

• Report covers the six months ended June 30, 2026, with comparative figures for 2025.

• Achieved positive topline results in the pivotal LANTERN Phase 3 trial, showing a 40.5% relative reduction in 30-day surgical site infection risk with no treatment-related serious adverse events in 5,188 patients.

• Advanced commercial adoption of Steriwave in Canada, the UK, and Mexico, including first Scottish hospital deployment and multi-centre pilot in Mexico.

• Focus remains on development and commercialization of antimicrobial photodynamic therapy (aPDT) products.

• Company continues to operate at a net loss and faces material uncertainty regarding going concern status.

Financial highlights

• Revenue increased 23% year-over-year to $1.25 million in H1 2026, driven by increased utilisation and new hospital deployments; gross margin stable at 65%.

• Net loss widened to $16.2 million from $12.6 million year-over-year; operating cash outflow increased to $13.3 million.

• R&D costs rose to $11.5 million (H1 2025: $8.0 million), mainly due to LANTERN trial investment.

• Cash and cash equivalents at $5.3 million as of June 30, 2026, with current funds expected to last into mid-Q4 2026.

• Gross margin improved to $811K from $657K year-over-year.

Outlook and guidance

• Priorities for H2 2026 and 2027 include completing and publishing LANTERN analyses, advancing U.S. regulatory engagement, and expanding commercial pilots and deployments.

• Management believes existing cash and future financings will be needed to meet liquidity needs for at least the next twelve months.

• R&D and operating expenses expected to materially decrease as LANTERN trial activities wind down.

• Equity fundraising process commenced to support regulatory submissions, commercial expansion, and working capital.

• Material uncertainty remains regarding the ability to continue as a going concern.