Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF), a leading developer of a new class of synthetic anti-infectives, has released its Q1 FY2026 results and operational highlights which include:
* Patient dosing underway with multiple sites now active in the registrational Phase 3 clinical trial for diabetic foot infections in Indonesia.
* RECCE® 327 Topical Gel (R327G) demonstrated strong in-vivo efficacy against Methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa in infected burn wounds.
* R327 recognised in the World Health Organization's 2025 Global Antibacterial Pipeline Report.
* Abstract and poster presentation featured at the United States Military Health System Research Symposium 2025.
* FY2025 Annual Report to shareholders released.
Phase 3 DFI trial in Indonesia
Patient dosing is underway in Recce's registrational Phase 3 clinical trial for diabetic foot infections (DFI) in Indonesia, with five clinical sites now active and the study tracking to an interim analysis in Q1 CY2026. Up to 310 patients will be randomised to receive either RECCE® 327 Topical Gel (R327G) or placebo.
The primary endpoint is clinical response per the FDA-recognised Lipsky Scale, with secondary measures including a total wound score and safety (clinical observations and adverse events).
Under a BPOM-approved protocol with Expedited Regulatory Review, the statistical plan anticipates a highly significant positive endpoint after approximately 155 patients; an independent data committee will conduct the built-in interim analysis in Q1 2026.
Indonesia: large unmet need and accessible trial environment
Indonesia has an estimated 20.9 million adults with diabetes (~11.3% of adults), among the highest rates in Southeast Asia and fifth globally, underscoring the scale of infection-related complications. Around 60% of diabetic foot ulcers become infected and can progress to sepsis, gangrene, amputation, and death -- highlighting the need for broad-spectrum options across DFI, urinary tract, and surgical site infections.
Recent regulatory changes have increased approval timelines for new drugs while making it cheaper and easier for foreign sponsors to conduct clinical trials locally. Recce's Phase 3 program is among the largest DFI studies globally.
Preclinical efficacy: strong antimicrobial and healing signals
In rat burn-wound infection models, R327G delivered statistically significant antibacterial activity against two priority AMR pathogens -- MRSA (ATCC43300) and Pseudomonas aeruginosa (ATCC27853).
Bacterial load reductions reached ~2-log by Day 4 and ~3-log by Day 8 for MRSA, and ~3-log by Day 4 and ~4-log by Day 8 for P. aeruginosa. R327G consistently outperformed Soframycin, a standard topical comparator.
Wound contraction improved significantly versus untreated control throughout the treatment period, and R327G was well tolerated with no adverse clinical signs or weight effects.
External validation and scientific visibility
The World Health Organisation's 2025 Global Antibacterial Pipeline report recognises RECCE® 327 as the only synthetic polymer antibiotic in clinical development, categorised as an ATP disruptor with broad-spectrum activity (including ESKAPE pathogens).
At the 2025 US Military Health System Research Symposium (Kissimmee, 4-7 August 2025), Recce presented an abstract and poster detailing R327's laboratory activity against high-priority biodefense pathogens: Bacillus anthracis, Francisella tularensis, Burkholderia mallei, Burkholderia pseudomallei, and Yersinia pestis.
Financial position and capital management
The company ended the quarter with A$3.17 million in cash. Net operating cash outflows were (A$6.92 million), driven primarily by R&D expenditure of A$5.30 million to support clinical and preclinical programs; payments to related parties totalled (A$1.48 million).
A near-term inflow is expected via the Australian R&D Rebate. Recce also extended its At-the-Market (ATM) agreement with Acuity Capital to January 31, 2031; A$150,000 has been raised to date, with 4.5 million collateral shares currently on issue and capacity to increase equity availability by up to A$19.85 million.
The facility can be cancelled at any time, including buy-back and cancellation of collateral shares for nil consideration (subject to shareholder approval).
Outlook
The anticipated R&D Rebate is expected to support continued Phase 3 execution and regulatory engagement for potential expedited approval pathways in Indonesia.
With advancing clinical programs, growing external recognition, and the Q1 2026 interim analysis as a key catalyst, Recce positions itself for meaningful clinical and commercial milestones in the coming months.