Acurx Pharmaceuticals Q4 2024: Unraveling Contradictions in Phase 3 Trial Funding and Regulatory Pathways

These are the key contradictions discussed in Acurx Pharmaceuticals' latest 2024Q4 earnings call, specifically including: Phase 3 Trial Funding Options and Partnership Strategies, Regulatory Pathway for Approval, Partnership Strategy and Funding Sources, and Timeline for Phase III Trials:



Phase 3 Clinical Trial Preparation:
- Acurx Pharmaceuticals is finalizing preparation to advance its lead antibiotic candidate, ibezapolstat (IBZ), for the treatment of C. difficile infection into international Phase 3 clinical trials.
- The goal is to complete these trials to form the basis for a new drug application in the US and a marketing authorization application for the European Union.

Regulatory Alignment and Pathway:
- The company received positive regulatory guidance from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for the IBZ Phase III clinical trial program.
- This alignment ensures a consistent pathway and provides Acurx with the necessary regulatory support to proceed with its Phase 3 program.

Financial Performance and Cash Position:
- Acurx ended the year with a cash balance of $3.7 million, compared to $7.5 million as of December 31, 2023.
- The decrease in cash is primarily due to the company's ongoing research and development expenses, despite the company raising a total of $6.6 million under its ATM financing program for the year.

Research and Development Expenditure Reduction:
- Research and development expenses for the year ended December 31, 2024, were $5.4 million, down from $6 million the previous year.
- This decrease was mainly driven by a $1.6 million reduction in consulting-related costs, although it was partially offset by a $1 million increase in manufacturing-related costs.

Regulatory Designations and Market Potential:
- Acurx's IBZ candidate has received QIDP and Fast Track designations from the FDA for the treatment of C. difficile infection, which can potentially reduce the overall annual cost burden in the US for C. difficile infection, estimated at $5 billion annually.
- If approved, IBZ could favorably impact public health costs due to its potential to reduce the incidence of recurrence.