Recce Pharmaceuticals Ltd
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- Recce Pharmaceuticals Ltd (ASX:RCE; OTCQX:RECEF), a clinical-stage biotechnology company headquartered in Sydney, Australia, and founded in 2007, discovers, develops and commercializes a proprietary new class of synthetic polymer anti-infectives designed to address antibiotic-resistant superbugs and emerging viral pathogens through a universal mechanism of action that targets bacterial and viral cell walls without promoting resistance. The company's lead product candidate, RECCE 327 (R327), is a broad-spectrum synthetic anti-infective available in intravenous, topical gel and nebulized formulations for treating serious bacterial infections including sepsis, urinary tract infections (UTIs), urosepsis, diabetic foot infections (DFI), acute bacterial skin and skin structure infections (ABSSSI), burn wounds and infections caused by ESKAPE pathogens such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae and Enterobacter species; RECCE 435 (R435) is an oral formulation for bacterial infections; and RECCE 529 (R529) targets viral infections including respiratory pathogens. Operations span Australia, the United Kingdom, the United States and Southeast Asia, with a focus on priority pathogens recognized by the World Health Organization and Qualified Infectious Disease Product (QIDP) designation from the US FDA for R327, granting Fast Track status and 10 years of market exclusivity post-approval. In 2025, Recce announced a A$30 million debt facility to fund Phase III trials, completed a A$5.0 million placement and entitlement offer raising up to A$15.8 million to support registrational Phase III trials for DFI in Indonesia and ABSSSI in Australia following positive Phase II topical gel results exceeding 93% efficacy, secured Indonesian regulatory approval for Phase III DFI topical trials, partnered with the US Army and US Department of Defense receiving US$2 million for R327 gel in burn wound infections, expanded Phase II DFI trials and advanced nebulized R327 for lung infections; earlier initiatives included a 2024 strategic partnership with Indonesian biotech Etana for clinical acceleration, Phase II ABSSSI trial dosing completion and multiple patent grants in China, Israel and Canada. The company, formerly Recce Limited until its 2017 name change, maintains a single-segment focus on anti-infective research and development with strategic collaborations such as Murdoch Children's Research Institute for gonorrhoeae, abscessus and E. coli trials.
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