Recce Pharmaceuticals (RCE) Ord Minnett Biotech & MedTech Conference Presentation summary

Company overview and financials

• Clinical-stage biotech developing novel synthetic anti-infectives with proprietary, broad-spectrum compounds targeting bacteria.

• Market cap of AUD $106.66 million, cash at bank AUD $6.33 million, no debt, and 231.87 million shares on issue.

• Awarded AUD $54.95 million Advanced Overseas Finding, extending R&D rebates globally for three years.

• Multiple clinical programs in Phase I/II for sepsis, UTI/urosepsis, burn wounds, and ABSSSI, including diabetic foot infections.

• Manufacturing facility in Sydney produces 5,000 GMP doses weekly, supporting scalability and cost efficiency.

Pipeline, clinical progress, and regulatory milestones

• Lead asset RECCE® 327 Gel entering Phase III in Indonesia for diabetic foot infection, with commercial launch expected in 2026.

• US FDA Qualified Infectious Disease Product designation provides 10 years of market exclusivity and fast-track approval.

• Phase I/II trials show R327 is safe, well-tolerated, and effective, with rapid bacterial reduction and no serious adverse events.

• Phase II ABSSSI trial shows all patients completing treatment achieved cure or improvement, with no serious adverse events.

• Regulatory submissions advanced in Indonesia, with Phase III trial approval imminent and expansion plans for ASEAN region.

Scientific highlights and mechanism of action

• R327 demonstrates rapid, irreversible bactericidal action by disrupting ATP production in bacteria, effective against ESKAPE pathogens.

• Maintains activity after 25+ repeats with no resistance, unlike amoxicillin.

• Faster-acting than existing antibiotics, killing bacteria in minutes without harming eukaryotic cells.

• Multiple formulations available: intravenous, topical gel, liquid, and aerosol.

• Effective in preclinical models against E. coli, S. aureus, M. abscessus, and S. pneumoniae.