Acurx Pharmaceuticals (ACXP) Study update presentation summary

Corporate overview and strategy

• Focus on developing a new class of antibiotics targeting WHO/CDC priority pathogens and antimicrobial resistance.

• Lead asset ibezapolstat (IBZ) targets C. difficile infection (CDI) and is Phase 3 ready, with a novel mechanism of action validated in Phase 2b trials.

• Pipeline includes ACX-375C, a preclinical candidate targeting MRSA, VRE, PRSP, and anthrax.

• Strategic alternatives under consideration include independent build-out, partnering, and M&A initiatives.

• Cash on hand as of June 2025 is $6.1 million, with no debt and 1.97 million fully diluted shares outstanding.

Clinical development and efficacy

• IBZ achieved a 96% cure rate in Phase 2 trials with 100% sustained clinical cure and no recurrence at 30 and 90 days.

• Outperformed vancomycin in rapid eradication of C. difficile and preservation of key gut microbiota.

• Phase 3 trial design approved by FDA/EMA, with primary endpoint of clinical cure and secondary endpoints including sustained cure and microbiome effects.

• Pilot study in patients with multiple CDI recurrences and resistance to standard care to begin enrollment in 1Q2026.

• IBZ preserves and enhances the microbiome, reducing recurrence risk compared to current standards.

Market opportunity and unmet need

• CDI market projected to grow from $1.5 billion in 2023 to $2.3 billion by 2032.

• Existing antibiotics have high reinfection rates (20-40%) and increasing antimicrobial resistance.

• No new antibiotics in clinical development have shown improvement in initial or sustained clinical cure rates for CDI.

• IBZ positioned to become first-line treatment for CDI if approved.

• Live biotherapeutic products and vaccines have limitations and are not suitable for first-line CDI treatment.