Recce Pharmaceuticals Prepares for Pivotal Trials with A$15.8 Million Funding Injection

Highlights

• Recce Pharmaceuticals secures A$15.8 million for pivotal Phase 3 trials.
• Key focus on diabetic foot infections and skin infections across Asia-Pacific and Australia.
• US clinical plans advance with FDA submission in view for late 2025.

Recce Pharmaceuticals (ASX:RCE) is set to accelerate its clinical development program following a successful funding round totaling A$15.8 million. The capital raise, structured through a share placement and entitlement offer, is aimed at progressing pivotal Phase 3 trials for its lead anti-infective candidate, R327 topical gel (R327G).

Strategic Allocation of Funds

The funding package includes a completed A$5 million private placement and a further entitlement offer to raise up to A$10.8 million, both priced at A$0.28 per share. If fully subscribed, the offer would inject a total of A$15.8 million into Recce’s operations, an ASX healthcare stock, covering expenses well into the second quarter of FY2026.

The primary allocation of funds will support a registration-enabling Phase 3 trial targeting diabetic foot infections (DFIs) in Indonesia. Around A$5.6 million is earmarked for this study, which will be conducted at PT Siloam International Hospitals, the largest private hospital network in the country. The study is expected to begin in Q2 2025 and aims to enrol 300 patients. Interim results are anticipated by early 2026, which could pave the way for a regional launch across ASEAN nations.

Dual Market Strategy and Global Ambitions

Simultaneously, Recce is preparing a separate Phase 3 trial in Australia for treating acute bacterial skin and skin structure infections (ABSSSI), backed by A$4.6 million from the raise. Subject to Investigational New Drug (IND) approval by the US FDA, the Australian trial may extend to US sites or trigger a parallel trial stateside. The IND submission is planned for late 2025 or early 2026, aiming for market entry in 2028.

Additional allocations from the raise include A$2 million for regulatory submissions, A$2.5 million towards a US Department of Defense-supported burn wound program, and A$1.1 million for working capital and offer costs.

Strengthening the Clinical Foundation

Alongside these initiatives, Recce recently received approval to expand its ongoing Australian Phase II DFI study, allowing up to 20 new patients. Previous data showed strong clinical response rates, reinforcing the potential of R327G as a frontline treatment option.

With a clear development roadmap, strategic funding, and ongoing international collaborations, Recce Pharmaceuticals (RCE) is positioning itself to transition from clinical-stage to commercial-stage in the coming years, as pivotal trials commence and regulatory engagements progress.