Recce Pharmaceuticals (RCE) Investor Presentation summary

Commercial and clinical progress

• R327 Gel nearing commercialisation for diabetic foot infections, with Indonesian Phase III trial initiated and expected launch in 2026; US/AUS Phase III to start in 2025 with commercial launch in 2028.

• Phase II in Australia for acute bacterial skin and skin structure infection (ABSSSI) nearing completion, with all patients achieving cure or improvement.

• Strong Indonesian partnership minimises Phase III costs and accelerates regulatory pathway, with expedited review status granted.

• Multiple clinical programs in Phase I, II, and III, including for UTI/urosepsis and burn wound infections.

• Highly efficient capital structure, low manufacturing costs, and 43.5% Australian R&D rebate on global activities.

Product pipeline and mechanism of action

• R327 demonstrates rapid, irreversible bactericidal activity against both Gram-positive and Gram-negative bacteria, including ESKAPE pathogens.

• Maintains efficacy over repeated exposures with no observed resistance, outperforming amoxicillin in repeat tests.

• Host cells are not negatively impacted by R327, and the compound targets bacterial energy production (ATP), leading to cell death.

• Demonstrated effectiveness in preclinical and clinical settings for diabetic foot infections, ABSSSI, UTI/urosepsis, and burn wounds.

• R327 shows strong activity in human urine, achieving rapid bacterial kill and high urine concentrations, supporting UTI/urosepsis indications.

Clinical trial results and case studies

• Phase I/II DFI trial met all primary endpoints, with infections resolved or cured and R327 well-tolerated.

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

• Multiple patient case studies under TGA Special Access Scheme showed rapid infection resolution, wound healing, and avoidance of surgical intervention.

• Intravenous R327 Phase I trial demonstrated safety, tolerability, and high urine concentrations, with no serious adverse events.

• Fast-infusion clinical trial for UTI/urosepsis completed, supporting future regulatory submissions and first-line treatment positioning.