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Acurx Pharmaceuticals(ACXP) - 2025 Q3 - Earnings Call Transcript
2025-11-12 14:00
Financial Data and Key Metrics Changes - The company ended Q3 2025 with cash totaling $5.9 million, an increase from $3.7 million as of December 31, 2024 [11] - The net loss for Q3 2025 was $2 million, or $1.23 per diluted share, compared to a net loss of $2.8 million, or $3.45 per diluted share for Q3 2024 [14] - For the nine months ended September 30, 2025, the net loss was $6.4 million, or $5.01 per diluted share, compared to a net loss of $11.3 million, or $14.23 per share for the same period in 2024 [14] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $0.4 million, down from $1.2 million in Q3 2024, primarily due to a decrease in manufacturing and consulting costs [11][12] - General and administrative expenses remained consistent at $1.6 million for Q3 2025 compared to Q3 2024, with a slight decrease in compensation-related costs offset by an increase in legal fees [12] Market Data and Key Metrics Changes - The company regained compliance with NASDAQ listing requirements after a 1-for-20 reverse stock split on August 4, 2025 [4][5] - Acurx has obtained multiple patents for its DNA polymerase 3C inhibitors, including a new patent granted by the Australian Patent Office [5][8] Company Strategy and Development Direction - The company is focused on advancing its ibezapolstat program, which has shown promising results in treating C. diff infections [9][10] - Acurx is pursuing funding opportunities for a phase three clinical trial program for ibezapolstat and is considering alternative pathways for success [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the macroeconomic environment and industry challenges while continuing to strengthen ibezapolstat's competitive profile [10] - The company recognizes November as C. diff Awareness Month and supports initiatives for education and prevention [10] Other Important Information - The company has FDA QIDP and FAST TRACK designations for ibezapolstat, which could significantly impact the economic burden of C. diff infections in the U.S. [10] - Acurx is actively engaged in scientific collaborations, with recent publications highlighting the structural biology of ibezapolstat [8] Q&A Session Summary Question: Potential for FDA to prioritize domestically manufactured novel antibiotics - Management sees potential for increased prioritization but noted uncertainty regarding the PASTOR Act and its impact on antibiotic funding [18][19] Question: Impact of proposed clinical priority review voucher framework - The regulatory approach and commercial strategy will remain the same, with plans to utilize the program at the appropriate time [21][22] Question: Filing for approval based on phase two ibezapolstat data - Management indicated that a safety database is required, and phase three trial data will be necessary for regulatory approval [23][25] Question: Timing around potential partnership discussions - Management expressed optimism about potential partnership news by the next earnings call but could not provide specific timelines [36][37] Question: QIDP and FAST TRACK designation expectations - Once obtained, these designations are maintained indefinitely without specific movement requirements [38] Question: Future operational expenses - Management anticipates that operational costs will continue to gradually decrease while maintaining a steady financial position [39]