Acurx Pharmaceuticals, Inc. Q3 FY2024 earnings call

• In July, ibezapolstat Phase II clinical trial results presented at the Anaerobe Society of the Americas, USPTO granted new patent for ibezapolstat covering C. difficile infection treatment. • August: Successful Phase II clinical meeting with FDA, submitted manufacturing request, CMC readiness for Phase III. • September: Executive Chairman Bob DeLuccia presented at World Antimicrobial Resistance Scientific Congress, participated in C. Difficile Symposium with presentations on ibezapolstat's Phase IIb results and pol IIIC mechanism of action. • October: Participated in ID Week with poster showing ibezapolstat comparable to vancomycin in clinical cure and safety. • Preclinical work: ACX-375 analogs show activity against Anthrax; planning Anthrax bioterrorism development program; GPSS program making progress on lead compound selection for gram-positive infections.

• Planning international Phase III trials, starting with Europe via EMA meeting likely in Q1 2025. • Preclinical work ongoing for Anthrax bioterrorism program. • GPSS program to start with MRSA in acute bacterial skin and skin structure infections, then move to VRE and DRSP. • Prefer non-dilutive funding options, including partnerships with government and territorial license/co-development partners.

• Uncertainties in clinical trial outcomes affecting regulatory approval. • Delays in regulatory processes, such as international filing initiatives. • Dependence on securing funding for Phase III trials. • Uncertainties in partnership negotiations and potential dilution concerns if partnerships involve dilutive terms.

Q: Can you discuss more about the predicted model that you discussed earlier on the call, a potential diagnostic tool?

A: David Luci explains that certain stool sample measurements can predict reinfection by the end of 3 days of treatment, which could be a diagnostic tool to reduce recurrent C. difficile infection costs. Physicians could use the test kit to swap treatments to prevent reinfection.

Q: Can you discuss more details about the international regulatory filing initiatives?

A: Starting with the European Medicines Agency in Europe, with a meeting likely at the tail end of 2024 or in Q1 2025 to set the regulatory pathway for international Phase III trials after FDA clearance.

Q: Outline what are some top options that you will consider likely to be able to fund the pivotal trials and which one will you prefer?

A: Prefer non-dilutive funding, including partnering options with government and territorial license/co-development partners, with active dialogue with several companies in Europe, Japan, and South America.

Q: Where are you currently in the development of the Anthrax bioterrorism program and what are some potential partnership opportunities?

A: The Anthrax program is preclinical; it involves lab and animal studies. Partnerships would likely be for government contracts related to stockpiling, but it's in early phases.

Q: What are other future clinical development plans for the preclinical GPSS program?

A: Start with MRSA in acute bacterial skin and skin structure infections, then move to VRE and DRSP infections.

Q: Did you say you're trying to hold off on that because of the amount of dilution that they're demanding? Can you talk a little more about that possibility of partnership in the near future?

A: Partnerships are time-consuming; looking for non-dilutive deals, with different parties looking at M&A and territorial deals, and government being a non-dilutive partner option.