Recce Pharmaceuticals Ltd ( ASX:RCE , OTC:RECEF ) closed the September quarter with further progress across its pivotal Phase 3 diabetic foot infection program, expanded intellectual property protection and A$21.4 million in available funding, including undrawn facilities.
The company received Human Research Ethics Committee approval for an amended Phase 3 trial design for RECCE® 327 Topical Gel (R327G) in Australia, adding an active-controlled component that will compare the treatment against commonly used antibiotics.
Recce also completed its Share Purchase Plan during the quarter, taking total proceeds from the Placement and SPP to A$6.4 million, while receiving a further A$3.6 million Research and Development Tax Incentive rebate.
Phase 3 trial design strengthened
The amended Australian Phase 3 protocol adds a randomised, active-controlled, non-inferiority component involving 208 participants.
Patients will be randomised between R327G and one of four physician-selected comparator antibiotics, generating comparative clinical data against established treatments for diabetic foot infections.
Recruitment and treatment of mild-to-moderate patients are continuing under the existing protocol ahead of implementation of the amendment.
An interim analysis is planned once 104 participants have been enrolled, treated and followed through to the end of treatment or withdrawal.
The Australian program complements Recce's Phase 3 study underway in Indonesia and forms part of a broader regulatory strategy spanning Australia, the US, Middle East and North Africa and ASEAN markets.
Indonesia review becomes near-term catalyst
After quarter-end, Recce submitted a 75-patient dataset from its Indonesian registrational Phase 3 study to an Independent Data Monitoring Committee for unblinded review.
The review followed analysis of blinded data by clinical experts and a statistician.
The committee may meet as early as mid-November, with potential recommendations ranging from progressing towards regulatory submission to continuing, modifying or halting the study.
Patient recruitment and dosing are continuing across both the Indonesian and Australian Phase 3 programs.
Patent portfolio expands
Recce also secured its eighth Family 4 patent during the quarter, with Vietnam granting protection covering the company's anti-infective platform until 2041.
The patent covers RECCE 327 and RECCE 529, including their preparation, use in bacterial and viral infections and administration through multiple delivery routes.
Vietnam joins Australia, Canada, China, Hong Kong, Israel, Japan and Brazil in granting Family 4 protection.
US opportunity grows
The quarter also coincided with the release of a five-year US$66.9 billion US medical countermeasures strategy , including a projected US$4.46 billion requirement for broad-spectrum antimicrobials.
Recce highlighted the relevance of this program to its existing US Army research collaborations and its US$2 million Congressionally Directed Medical Research Programs grant.
The company cautioned that there is no guarantee it will receive additional funding under the strategy.
Financial position
Recce ended September with A$1.04 million in cash, before an expected overseas R&D rebate.
Operating cash outflow was A$3.8 million, with research and development expenditure of A$5.8 million reflecting continued investment in human clinical trials and preclinical programs.
During the quarter, Recce received A$3.6 million through the R&D Tax Incentive, bringing FY2025 rebates to approximately A$8.9 million.
The company has also lodged its FY2026 tax return and expects to receive approximately A$7.5 million under the Australian R&D Tax Incentive.
Including undrawn financing facilities, total available funding at quarter-end was approximately A$21.4 million.
Commercial pathway advances
After quarter-end, Recce signed an exclusive licensing and commercialisation agreement with Arrotex Pharmaceuticals for R327G in Australia and New Zealand.
The agreement provides a potential commercial pathway for R327G, subject to successful clinical development and regulatory approval.
Negotiations are also continuing towards a definitive agreement under Recce's non-binding Middle East and North Africa term sheet.
Next steps
Recce's immediate focus is the Independent Data Monitoring Committee review of its Indonesian Phase 3 program and continued recruitment across its Australian study.
The company will also progress regulatory and commercial preparations for R327G, advance its Arrotex partnership and continue discussions around the MENA commercialisation opportunity.
Further clinical milestones from the Phase 3 diabetic foot infection program are expected to remain the key near-term catalysts.
