Recce Pharmaceuticals (RCE) Investor update summary

Clinical development and product innovation

• Advanced phase III trial underway for a novel antibiotic gel targeting diabetic foot ulcer infections, with commercial availability expected later this year.

• Multiple formulations (gel, IV, spray, inhalation) developed to address various infection sites and patient needs.

• Phase II trial showed over 90% positive clinical response in acute bacterial skin and skin structure infections, including diabetic foot ulcers.

• Product demonstrates rapid action, broad-spectrum efficacy, and minimal systemic absorption, supporting strong safety profile.

• No resistance observed in over 750 clinical isolates, with rapid bacterial kill in minutes.

Regulatory and commercial strategy

• Phase III trial in Indonesia aims for registration and commercial launch in 2024, leveraging expedited regulatory review.

• Approval in Indonesia opens access to ASEAN markets, with plans to expand into MENA and eventually the U.S.

• Commercial discussions and licensing opportunities are ongoing in multiple regions.

• Patent portfolio continues to expand, with recent grants in the U.S. and Brazil.

Strategic partnerships and global collaborations

• Strong collaboration with Etana in Indonesia, supported by both Indonesian and Australian governments.

• Siloam Hospitals network actively involved in clinical trials, enhancing local relevance and patient access.

• U.S. Department of Defense programs support development for military and biodefense applications, including burn and blast wound infections.

• Multiple U.S. government-funded programs (CDMRP, CRADAs) validate product potential and drive further opportunities.