Recce Pharmaceuticals Raises A$15.8M to Fund Critical Phase 3 Studies
Recce Pharmaceuticals has completed a A$15.8 million capital raise to fund pivotal Phase 3 clinical trials and progress its FDA application, positioning the company for potential commercial breakthroughs in antibiotic-resistant infections.
- Completion of A$15.8 million capital raising including private placement and entitlement offer
- A$7.4 million raised from shortfall placement to institutional and sophisticated investors
- Funds to support Phase 3 clinical trials in Indonesia and Australia for diabetic foot and skin infections
- Advancement of Investigational New Drug Application to US FDA
- Pro-forma cash balance of A$16 million plus expected R&D rebates and advances
Capital Raising Completion
Recce Pharmaceuticals Ltd (ASX, RCE) has successfully closed its A$15.8 million capital raising, marking a significant milestone for the biotechnology company focused on synthetic anti-infectives. The raise combined a A$5 million private placement, a 1-for-6 pro-rata entitlement offer, and a shortfall placement that brought in an additional A$7.4 million from existing institutional and sophisticated investors. This final tranche completes the funding round initiated earlier this year.
Funding Phase 3 Clinical Trials
The fresh capital is earmarked primarily for advancing Recce’s Phase 3 clinical trials targeting diabetic foot infections (DFI) in Indonesia and acute bacterial skin and skin structure infections (ABSSSI) in Australia. These registrational trials are critical steps toward commercialisation, with the DFI trial expected to be a revenue catalyst by 2026. The company is also progressing its Investigational New Drug Application with the US Food and Drug Administration, aiming to secure regulatory approval in a key global market.
Strategic Position and Market Potential
Recce’s synthetic anti-infective candidates, including RECCE® 327, 435, and 529, address the urgent global challenge of antibiotic-resistant superbugs. The World Health Organization and US FDA have recognised these candidates for their potential, granting priority designations that could accelerate market entry. The company’s proprietary technology and automated manufacturing capabilities underpin its clinical programs and future commercial ambitions.
Financial Outlook and Support
Following the capital raise, Recce’s pro-forma cash position stands at approximately A$16 million, excluding an anticipated A$8.5 million R&D tax rebate and a potential A$10 million R&D advance. This financial runway provides a solid foundation to support ongoing clinical activities and regulatory submissions. Company leadership expressed confidence in the strong institutional backing and the strategic importance of this funding round amid a challenging capital environment for biotechnology firms.
Looking Ahead
With Phase 3 trials underway and regulatory milestones in sight, Recce is poised for a transformative period. The outcomes of these trials and subsequent FDA decisions will be pivotal in determining the company’s trajectory and its role in addressing critical infectious diseases worldwide.
Bottom Line?
Recce’s capital raise sets the stage for pivotal clinical milestones that could redefine treatment options for resistant infections.
Questions in the middle?
- What are the anticipated timelines and success probabilities for the Phase 3 trials in Indonesia and Australia?
- How might the FDA’s response to the Investigational New Drug Application influence Recce’s commercial prospects?
- What impact will the expected R&D rebates and advances have on the company’s financial stability and future funding needs?
