Acurx Pharmaceuticals, Inc. Q4 FY2024 earnings call

["Advancing lead antibiotic candidate ibezapolstat for C. difficile infection into international Phase 3 trials.", "Exhibited at ID Week in Oct 2024, where Phase 2 data showed ibezapolstat had comparable clinical cure and safety to vancomycin.", "Published microbiome studies in Feb 2025, including in-silico and head-to-head mouse model studies supporting ibezapolstat's differentiating effects on gut microbiome.", "Japanese Patent Office granted a new patent for DNA polymerase IIIC inhibitors in Feb 2025.", "Closed registered direct offerings in Jan and Mar 2025, raising gross proceeds of $2.5 million and $1.1 million respectively."]

No product segments were discussed; financials included cash of $3.7 million as of Dec 31, 2024 (down from $7.5 million in 2023), R&D expenses for Q4 2024 were $0.8 million (down from $1.9 million in 2023), G&A expenses for Q4 2024 were $2 million (down from $3.2 million in 2023), net loss for Q4 2024 was $2.8 million, and full year net loss was $14.1 million.

["Anticipates starting Phase 3 trials in 2025, with top line data expected about 2 years from first patient enrollment.", "Funding for Phase 3 trials is being pursued through partnerships, grants, and government programs, with a potential time lag between securing funding and starting trial enrollment."]

["Uncertainties in securing partnerships, especially with private sector entities, and potential delays due to market turmoil and political/regulatory uncertainties.", "Risks associated with regulatory approvals and the time required to complete clinical trials and obtain necessary authorizations."]

Q: Discuss notable differences and similarities between FDA and EMA expectations for Phase 3?

A: Protocols are identical, with complete agreement from both agencies.

Q: How envisioned to enroll patients geographically in Phase 3?

A: 150 clinical trial sites, 50% in Europe, 30% in US, rest in Canada/South America.

Q: When to expect more data on ibezapolstat?

A: Full set of Phase 2 data to be published in next 30 days.

Q: Options to fund development of ACX-375 into clinic?

A: Pursuing partnerships, grants, or government programs.

Q: Partnership environment and Phase 3 timeline?

A: Potential partnerships with non-pharmaceutical groups more advanced; Phase 3 enrollment expected in 2025, top line data in 2 years from first patient enrollment.

Q: Risk with NASDAQ listing and ATM program?

A: ATM suspended in Jan, but reactivation possible; confident in managing NASDAQ listing issues.