Recce Pharmaceuticals (RCE) investor relations material

Strategic positioning and product pipeline

• Focus on anti-infective solutions addressing antibiotic resistance, with products acting faster than traditional antibiotics and effective against multidrug-resistant bacteria.

• Lead product RECCE® 327 Gel is in Phase 3 clinical trials for diabetic foot infections (DFI) in Indonesia, with interim data expected in Q3 2026 and commercialisation targeted for 2027.

• Multiple clinical indications and formulations, including intravenous, topical, and inhaled options, are in development to address unmet medical needs.

• Signed a non-binding term sheet for a 10-year exclusive multi-country licensing agreement in the Middle East.

• Collaborations with US Defense agencies support product potential for burn and wound infections.

Clinical efficacy and safety

• RECCE® 327 demonstrates broad-spectrum, rapid bactericidal activity against ESKAPE pathogens, with no observed resistance after repeated exposures.

• Phase I/II and II trials for topical gel in DFI and ABSSSI achieved all primary and secondary endpoints, showing high efficacy and safety with no serious adverse events.

• Case studies under the TGA Special Access Scheme show rapid infection resolution and avoidance of surgical intervention.

• Phase I intravenous study confirmed safety up to 6,000mg, with high urinary concentrations suggesting potential for UTI treatment.

• Fast-acting mechanism validated in independent studies, with rapid bacterial kill in both plasma and urine environments.

Market opportunity and regulatory progress

• The global DFI market is valued at US$5.8B, with over 589 million adults worldwide living with diabetes; high unmet need in Indonesia and MENA regions.

• Accelerated regulatory review in Indonesia, with potential access to 10 ASEAN member states and a large diabetic population.

• Phase 3 trials in Indonesia and Australia/USA are designed for global registration, with interim data and commercial launches planned from 2026 onward.

• RECCE® 327 granted QIDP designation by the US FDA and included in the WHO's list of antibacterial products in clinical development.