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 $3.7 million, down from $7.5 million in 2023, and raised $6.6 million through its ATM financing program [5][6] - Research and development expenses decreased to $5.4 million in 2024 from $6.0 million in 2023, primarily due to reduced consulting costs [6] - General and administrative expenses for Q4 2024 were $2.0 million, down from $3.2 million in Q4 2023, reflecting cost-cutting measures [7] Shareholder Information - Acurx reported a net loss of $2.8 million for Q4 2024, an improvement from a $5.1 million loss in Q4 2023, with a total annual net loss of $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