Recce Pharmaceuticals (RCE) H2 2025 earnings summary

Executive summary

• Advanced lead anti-infective R327G into Phase 3 registrational trial for diabetic foot infections (DFI) in Indonesia, with interim analysis planned for accelerated approval in H1 2026.

• Completed Phase II trial for ABSSSI, achieving 93% efficacy at day 14 and no serious adverse events, supporting further DFI patient enrolment.

• Secured A$15.8 million in equity and A$11.5 million in non-dilutive debt, with an additional A$19 million available, ensuring a strong cash runway.

• Awarded US$2 million grant from US Department of Defense for burn wound program and entered a research agreement with USAMRIID for biothreat pathogens.

• Expanded global patent portfolio, with new patents granted in Australia, Japan, and China, extending protection beyond 2040.

Financial highlights

• Total income of $7.7 million, primarily from R&D tax incentives and grants.

• Operating loss increased to $21.4 million (2024: $17.7 million), mainly due to higher R&D expenditure.

• Cash and cash equivalents at year-end: $10.4 million (2024: $4.4 million).

• Net deficiency in equity of $3.1 million, improved from $9.5 million deficit in 2024.

• No dividends declared or paid during the year.

Outlook and guidance

• Indonesian Phase 3 DFI trial expected to conclude within 12 months, targeting regulatory approval and commercial launch in H1 2026.

• Preparations underway for Phase 3 DFI trial in Australia to US FDA standards.

• Phase II IV trial for UTI/urosepsis planned for FY26.

• Ongoing expansion of manufacturing capacity and global commercial partnerships.