Recce Pharmaceuticals Ltd has reported solid operational momentum in its December 2025 quarter, highlighted by continued progress in its registrational Phase 3 clinical trial for diabetic foot infections (DFI) in Indonesia and encouraging new preclinical data for inhaled RECCE® 327 in hospital-acquired pneumonia models.
The company also strengthened its intellectual property position with a new Hong Kong patent grant and secured meaningful non-dilutive funding support through Australia’s R&D tax incentive framework.
Phase 3 DFI trial progresses in Indonesia
Recce said patient dosing is continuing across activated clinical sites in Indonesia as part of its Phase 3 trial evaluating RECCE® 327 Topical Gel (R327G) for diabetic foot infections.
The study is targeting an interim, approvable data set of 155 patients, with up to 310 patients to be randomised overall, making it one of the largest DFI trials globally. The primary endpoint is clinical response measured using the US Food and Drug Administration (FDA)-recognised Lipsky Scale, with secondary endpoints assessing wound scores and safety.
Indonesia represents a significant potential market, with more than 20.9 million adults living with diabetes and in-hospital DFI treatment costs averaging around A$6,000 per patient, excluding the higher costs associated with amputations. The trial protocol includes a built-in interim analysis and has been granted expedited regulatory review status by Indonesia’s drug regulator BPOM.
Inhaled R327 delivers strong pneumonia efficacy in preclinical study
During the quarter, Recce reported further positive preclinical results from an ongoing research collaboration with the Murdoch Children’s Research Institute, assessing inhaled R327 in models of hospital- and ventilator-acquired pneumonia caused by carbapenem-resistant Acinetobacter baumannii.
The study showed that both intranasal and nebulised delivery of R327 significantly reduced bacterial load in the lungs. Nebulised R327 achieved a 4-log (>99.99%) reduction in bacterial burden, with counts approaching the lower limit of detection.
Recce noted that, unlike meropenem, a last-resort antibiotic with solubility and toxicity limitations, R327 can be effectively nebulised — a practical advantage for treating serious lung infections.
IP strengthened with Hong Kong patent grant
Recce also received formal approval for its Family 4 anti-infectives patent in Hong Kong, extending protection through to 2041. This marks the sixth granted patent in the family, alongside approvals in Australia, Canada, Israel, Japan and China.
The company said the expanded IP coverage supports its broader ASEAN and regional commercial strategy as it advances regulatory pathways beyond Indonesia.
Financial position supported by R&D incentives
At quarter end, Recce held cash of $400,000, excluding a $5.3 million R&D tax incentive rebate received post-quarter. A further ~$3.5 million rebate is expected in the current quarter, completing the FY25 claim.
Post-quarter, Recce was also awarded an AusIndustry Advanced Overseas Finding covering up to $85 million of eligible R&D expenditure over three years, confirming that overseas programs — including the Indonesian Phase 3 trial — qualify for the 43.5% R&D tax incentive.
Honouring a founding legacy
During the quarter, Recce also announced the passing of founder and inventor Dr Graham Melrose, acknowledging his foundational role in developing the company’s synthetic anti-infective platform and guiding its long-term scientific vision.