Core Insights - Acurx Pharmaceuticals reported significant clinical trial results for its lead antibiotic candidate, ibezapolstat, demonstrating comparable efficacy to vancomycin in treating C. difficile infections [1][2] - The company received positive regulatory guidance from the European Medicines Agency (EMA) for its Phase 3 clinical trial program, aligning with FDA feedback, which positions Acurx favorably for international trials [2][12] - Financial results showed a net loss reduction in Q4 2024 compared to Q4 2023, indicating improved financial management despite a decrease in cash reserves [5][8] Clinical Developments - Ibezapolstat exhibited a 96% clinical cure rate in Phase 2 trials, with 100% of patients remaining cured one month post-treatment, compared to 86% for vancomycin [1] - The drug's mechanism includes preservation of beneficial gut bacteria, which may prevent recurrence of C. difficile infections [1][2] - Acurx's studies indicate that ibezapolstat has a more selective impact on the gut microbiome compared to broader-spectrum antibiotics, potentially offering a competitive advantage [3][4] Financial Performance - The company ended 2024 with cash reserves of 7.5 million in 2023, and raised 5.4 million in 2024 from 2.0 million, down from 2.8 million for Q4 2024, an improvement from a 14.1 million for 2024 [8][17] - The company had 17,030,686 shares outstanding as of December 31, 2024, reflecting an increase in shares issued compared to the previous year [9][16] Regulatory and Patent Developments - Acurx received a new patent for its DNA polymerase IIIC inhibitors from the Japanese Patent Office, expiring in December 2039, which supports its ongoing antibiotic development efforts [10] - The company is preparing to file a Marketing Authorization Application following successful Phase 3 trials, with a focus on the treatment of C. difficile infections [2][12]
Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update