• Patient dosing underway for Registrational Phase 3 Clinical Trial for Diabetic Foot Infections (DFI) in Indonesia
• Interim analysis results expected in Q1 2026, with potential accelerated approval and commercial launch in 2026
• Significant market opportunity with over 20.9 million adults in Indonesia living with diabetes

Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) has announced that patient dosing is underway for its Registrational Phase 3 clinical trial in Indonesia for the treatment of Diabetic Foot Infections (DFI) using RECCE® 327 Topical Gel (R327G). The trial has five clinical study sites now activated across one of the world's largest DFI patient populations. The trial's primary objective is to assess the clinical response of the DFI according to the Lipsky Scale, a valid and reliable method for evaluating treatment outcomes. Secondary endpoints include a DFI total wound score and safety of R327G. The Company expects to meet a highly statistically significant positive endpoint after dosing approximately 155 patients. The trial has a built-in interim analysis, and an independent data management committee aims to complete this analysis and make recommendations within Q1 2026. Upon receiving a positive result, the Company plans to pursue accelerated approval and a potential commercial launch in 2026. Indonesia presents a significant market opportunity, with over 20.9 million adults living with diabetes, representing approximately 11.3% of the nation's adult population.

The Company expects to meet a highly statistically significant positive endpoint after dosing approximately 155 patients in the Registrational Phase 3 clinical trial for Diabetic Foot Infections in Indonesia. Upon receiving a positive result, the Company plans to pursue accelerated approval and a potential commercial launch in 2026.