Recce advances RECCE 327 trial as key Indonesian review nears

Phase 3 Trial Gains Active Comparator Arm

Recce Pharmaceuticals Ltd (ASX:RCE) has moved its Australian RECCE 327 topical gel program closer to a conventional pivotal test, with ethics approval for a 208-patient randomised, active-controlled non-inferiority component in diabetic foot infections. Participants will be assigned either R327G or one of four physician-selected comparator antibiotics, creating head-to-head data against established treatment options.

The amended protocol also allows patients assigned to R327G to receive treatment for each qualifying infection during the study. Recce said this could increase the volume and depth of efficacy data, while a planned interim analysis will be conducted after 104 participants have completed treatment and follow-up. Recruitment under the existing protocol continues before the amendment is implemented. The development builds on the Australian active-comparator trial, which previously reported the ethics approval for the expanded design.

Indonesian Data Heads Towards Independent Review

The nearer-term event is in Indonesia, where Recce has submitted a 75-patient dataset to an independent Data Monitoring Committee after clinical experts and a statistician reviewed blinded data. The committee could meet as soon as mid-November. Its possible recommendations range from progressing towards regulatory submission to continuing, modifying or halting the study, while the company, investigators and patients remain blinded.

Recruitment and dosing continue across both the Indonesian and Australian Phase 3 programs. Recce says the two programs are intended to support a regulatory strategy spanning Australia, the United States, MENA and ASEAN markets. The filing does not disclose the DMC's assessment, so the review remains a material uncertainty rather than a clinical outcome.

Patent Protection Expands Across Southeast Asia

Vietnam has granted Recce a Family 4 patent covering RECCE 327 and RECCE 529, including preparation processes, infection-treatment uses and multiple delivery formats such as gels, topical foams, ointments, inhaled products and impregnated dressings. The patent is due to expire in 2041 and becomes the company's eighth Family 4 grant, joining protections in Australia, Canada, China, Hong Kong, Israel, Japan and Brazil.

Recce positioned the grant against Vietnam's expanding pharmaceutical market and significant antimicrobial-resistance burden. The patent strengthens the company's stated intellectual-property position in the region, but it does not itself establish commercial approval, sales or revenue.

Tax Rebates Offset Heavy Clinical Spending

Recce received A$3.6 million under the R&D Tax Incentive during the quarter, taking FY2025 rebates to about A$8.9 million. It also expects approximately A$7.5 million from its FY2026 tax return in the near term, subject to the claimed eligible activities and the company's stated overseas R&D finding.

Those inflows matter because operating cash use was A$3.83 million in the September quarter, including A$5.78 million on research and development. Recce ended the period with A$1.04 million in cash. Its Appendix 4C reports A$20.33 million of unused financing facilities and calculates 5.58 quarters of funding, but that figure includes facilities rather than cash already held and should not be read as a guaranteed cash runway.

U.S. Antimicrobial Strategy Creates Potential Funding Relevance

Recce also highlighted a five-year, US$66.9 billion U.S. medical-countermeasures strategy that identifies a projected US$4.46 billion requirement for broad-spectrum antimicrobials. The company said the priorities are relevant to its existing U.S. Army research collaborations and US$2 million CDMRP grant, but expressly cautioned that the strategy does not guarantee Recce any new funding.

Separately, the completed Share Purchase Plan issued 6.05 million shares at A$0.40 each and raised about A$2.4 million. Together with the prior institutional placement, the offer raised A$6.4 million before costs. Post-quarter, Recce also entered the Arrotex commercialisation agreement granting exclusive Australian and New Zealand rights for R327G, which remains in Phase 3 development and is not approved.

The next hard test is the Indonesian DMC review: it could clarify whether the program is moving towards regulatory preparation or requires more work. Until then, Recce's story rests on a widening clinical and commercial pathway funded by rebates, recent equity and available facilities, while the core product still faces the decisive hurdle of proving itself in controlled Phase 3 testing.