Recce Pharmaceuticals (RCE) Investor Presentation summary

Clinical trial results and milestones

• Phase II trial of R327 topical gel for ABSSSI, including diabetic foot infections, achieved all primary and secondary endpoints, with 93% efficacy at 14 days and no serious adverse events reported.

• Phase III registrational trial approved in Indonesia, targeting 300 patients, with expedited regulatory review and anticipated ASEAN market launch in 2026.

• Phase III studies will use the same FDA-accepted endpoints as Phase II, supporting a consistent regulatory approach.

• R327 gel demonstrated rapid onset of effect, with most responses by week 1, and robust safety profile.

• Indonesian approval expected to facilitate broader ASEAN regulatory access, including Malaysia, Philippines, Singapore, and Thailand.

Market opportunity and strategic positioning

• Global diabetic foot infection (DFI) and sepsis market exceeds $9.5 billion, with DFI treatment market at $5.2 billion.

• Initial focus on Indonesia, where DFI impacts 11% of the population and market is valued at ~$189 million.

• ASEAN region represents a $1 billion annual opportunity, with Indonesian approvals providing a gateway.

• Recce holds >40 granted patents in major markets, with exclusivity out to 2041 and QIDP designation from the US FDA.

• Manufacturing process offers significant economies and scalability, supporting commercial expansion.

Product differentiation and innovation

• R327 is a synthetic, broad-spectrum anti-infective with rapid action and no observed resistance, effective against Gram-positive and Gram-negative bacteria.

• Demonstrated efficacy against ESKAPE pathogens and classified by WHO as the only ATP production disruptor in clinical development.

• Multiple formulations in development: topical gel, intravenous, and aerosol for inhalation.

• R327 is not derived from nature and selectively targets prokaryotic cells, minimizing toxicity.

• Added to WHO's list of antibacterial products in clinical development.