• Successful Phase II clinical trial of RECCE® 327 topical gel (R327G) in patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) including Diabetic Foot Infections (DFI)
• 93% primary efficacy endpoint achieved for R327G over 14 days treatment
• Phase II data confirms approach for Approved Registrational Phase 3 DFI Indonesian Study

Recce Pharmaceuticals Limited announced positive patient data analysis from its Phase II clinical trial of RECCE® 327 Topical Gel (R327G) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The Phase II trial successfully demonstrated R327G achieving a 93% primary efficacy endpoint over 14-days, meeting all study endpoints. After 7-days of treatment, 86% of patients (25 out of 29) treated with R327G had a successful clinical response, and at 14-days, 93% of patients (27 out of 29) achieved the primary efficacy endpoint. R327G was also shown to be safe and well tolerated, with no serious adverse events reported. The study's high response rates have enabled experts to determine that the Company's current Registrational Phase 3 Study for Diabetic Foot Infections can meet a highly statistically significant positive endpoint after completing approximately 100 patients, compared to the original study baseline of 300 patients. The Indonesian Drug and Food Regulatory Authority (Badan POM) approved protocol has a built-in interim analysis, and the Company anticipates completing this data set by the end of 2025. The trial results continue to reinforce the unprecedented efficacy of Recce's synthetic technology, now in late-stage clinical trials, facilitated by an innovative regulatory strategy, supporting an accelerated commercialization pathway into 2026.

The global ABSSSI treatment market is a substantial commercial opportunity, valued at $7.3B USD in 2018 and expected to reach $26B USD by 2032, at a CAGR of 9.5% between 2019 and 2032.

Recce's anti-infective pipeline aims to address synergistic, unmet medical needs by leveraging its unique technologies. The Company is advancing towards registrational Phase 3 trials in Indonesia and Australia, encouraged by the rapid efficacy and strong safety outcomes demonstrated in the Phase II study.