Financial Data and Key Metrics Changes - The company ended 2024 with cash totaling $3.7 million, down from $7.5 million as of December 31, 2023 [25] - Research and development expenses for Q4 2024 were $0.8 million, a decrease of $1.1 million from $1.9 million in Q4 2023 [25] - General and administrative expenses for Q4 2024 were $2 million, down from $3.2 million in Q4 2023, primarily due to decreases in professional fees and share-based compensation [27] - The net loss for Q4 2024 was $2.8 million or $0.16 per diluted share, compared to a net loss of $5.1 million or $0.37 per diluted share in Q4 2023 [28] Business Line Data and Key Metrics Changes - The company is advancing its lead antibiotic candidate, ibezapolstat (IBZ), into international Phase 3 clinical trials for the treatment of C. difficile infection [8] - In Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96%, with 100% of patients remaining cured one month after treatment [9] Market Data and Key Metrics Changes - The company raised a total of $6.6 million in gross proceeds under its ATM financing program for the year ended December 31, 2024 [25] - The FDA has granted ibezapolstat QIDP and Fast Track designations for the treatment of C. difficile infection, indicating a favorable regulatory environment [22] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase 3 registration program following positive regulatory guidance from both the FDA and EMA [13] - Acurx aims to differentiate ibezapolstat from other antibiotics by demonstrating its microbiome-restorative potential and lower recurrence rates [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential economic impact of ibezapolstat, which could reduce the annual cost burden of C. difficile infection in the US, estimated at $5 billion [23] - The company is actively pursuing funding opportunities for its Phase 3 clinical trial program, including partnerships and grants [42] Other Important Information - The Japanese Patent Office granted a new patent for the company's DNA polymerase IIIC inhibitors, expiring in December 2039 [19] - The company closed a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million [20] Q&A Session Summary Question: Differences and similarities between FDA and EMA for Phase 3 program - Management confirmed that the protocols for the Phase 3 program are identical for both FDA and EMA, as they aligned their strategies before approaching the EMA [35] Question: Geographic enrollment for Phase 3 program - The plan is to start with 150 clinical trial sites, with approximately 50% in Europe and the remainder in the US, Canada, and South America [37] Question: Upcoming data releases for ibezapolstat - A full set of Phase 2 data is expected to be published in a prestigious scientific journal within the next 30 days [40] Question: Funding options for development of ACX-375C - Management is exploring various funding opportunities, including partnerships and government grants, to support the Phase 3 trial [42] Question: Partnership environment and timeline for Phase 3 trials - The current tumultuous market conditions have made securing partnerships challenging, but management is optimistic about starting Phase 3 trials in 2025 [56] Question: Timeline for top-line data from Phase 3 trials - Management indicated that it would take approximately two years from the first patient enrolled to obtain top-line data [62] Question: Status of ATM program and NASDAQ listing - The ATM program was suspended in January but can be reactivated when management decides. There is confidence in maintaining the NASDAQ listing despite current share price challenges [70][72]
Acurx Pharmaceuticals(ACXP) - 2024 Q4 - Earnings Call Transcript