Recce Pharmaceuticals Advances with 93% Efficacy in Phase II and $15.8M Capital Raise

Clinical Progress and Trial Outcomes

Recce Pharmaceuticals Ltd (ASX:RCE) has announced a pivotal milestone in its development pipeline with the successful dosing of all 30 patients in its Phase II clinical trial of R327G, a topical gel designed to treat Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The open-label study evaluated safety, tolerability, pharmacokinetics, and efficacy over a 14-day treatment period.

The trial results were notably positive, with R327G achieving a 93% primary efficacy endpoint at 14 days and an 86% clinical response rate at 7 days. Importantly, the treatment was well tolerated with no serious adverse events reported, meeting all study endpoints. These outcomes not only validate the therapeutic potential of R327G but also provide a strong foundation for Recce’s ongoing clinical development efforts.

Strategic Patent Expansion

In parallel with clinical progress, Recce secured a significant intellectual property win with the Japan Patent Office granting allowance for its Patent Family 4, extending protection for its anti-infective compounds until 2041. This patent complements existing protections in Australia, Canada, and Israel, reinforcing Recce’s global IP portfolio and enhancing its competitive positioning in the anti-infectives market.

Capital Raising to Fuel Phase III Trials

Financially, Recce reported a cash balance of just A$0.2 million at quarter-end, reflecting ongoing investment in research and development activities. To bolster its financial position and support late-stage clinical trials, the company completed a A$5 million placement to an existing Australian private investor and launched a non-renounceable entitlement offer to raise up to A$10.8 million from existing shareholders. Together, these initiatives aim to raise approximately A$15.8 million.

Proceeds from the capital raise will primarily fund the Registrational Phase III Diabetic Foot Infections (DFI) trial in Indonesia, expected to be a key revenue catalyst in 2026, as well as the Phase III ABSSSI trial in Australia and other clinical and regulatory activities including an Investigational New Drug Application to the FDA.

Future Funding and Operational Outlook

Beyond the equity raise, Recce anticipates additional funding through an estimated A$8.5 million R&D tax rebate from the Australian Taxation Office and approximately A$10 million in non-dilutive capital via an R&D advance facility. This diversified funding strategy provides a robust financial runway to advance its clinical programs and operational objectives.

The company’s recent Key Opinion Leader webinar further underscored its progress, featuring expert insights on the Phase II data and ongoing clinical activities, signaling strong scientific and industry support for Recce’s anti-infective portfolio.

Looking Ahead

With positive Phase II data in hand, strengthened patent protection, and a well-funded pathway into Phase III trials, Recce Pharmaceuticals is positioned to accelerate its clinical development and move closer to commercialisation. The upcoming interim analysis of the Phase III DFI trial in Indonesia, expected in Q1 2026, will be a critical inflection point for the company and its investors.