Acurx Pharmaceuticals(ACXP) - 2024 Q3 - Quarterly Report

Antibiotic Development - The company is developing a new class of small molecule antibiotics targeting difficult-to-treat Gram-positive bacterial infections, with a focus on Clostridioides difficile, MRSA, VRE, and DRSP[67][71]. - The Phase 2 clinical trial for the lead antibiotic candidate, ibezapolstat, showed a Clinical Cure rate of 96% across both Phase 2a and Phase 2b segments, compared to a historical vancomycin cure rate of approximately 81%[80]. - In the Phase 2b segment, 100% of ibezapolstat-treated patients who achieved Clinical Cure remained free of CDI recurrence through one month after treatment, while the standard of care (vancomycin) had a recurrence rate of 14%[81]. - The company plans to conduct Phase 3 clinical trials for ibezapolstat and has received confirmation of Phase 3 readiness from the FDA, with agreements on key elements for the international trial program[84]. - The company has a pipeline of early-stage antibiotic candidates, including ACX-375C, targeting Gram-positive bacteria, which has shown proof of concept in animal studies[76]. - Recent analyses indicated that ibezapolstat positively affects the gut microbiome, contributing to its anti-recurrence effect for CDI[78]. - A new patent was granted for ibezapolstat, focusing on its use to treat CDI while improving gut microbiome health, adding to the company's intellectual property portfolio[85]. - The company is evaluating strategic transactions for further development and potential commercialization of ibezapolstat, including partnerships or mergers[77]. Financial Performance - The company has not generated any revenue since inception and does not expect to do so in the near future[92]. - Research and development expenses for Q3 2024 were $1.2 million, a decrease of 11$1.3 million in Q3 2023[99]. - General and administrative expenses for Q3 2024 were $1.6 million, down 8$1.8 million in Q3 2023[101]. - Total operating expenses for Q3 2024 were $2.8 million, a 9$3.1 million in Q3 2023[99]. - Net loss for Q3 2024 was $2.8 million, a reduction of 9$3.1 million in Q3 2023[102]. - Research and development expenses for the nine months ended September 30, 2024, increased by 12% to $4.6 million from$4.1 million in the same period of 2023[103]. - General and administrative expenses for the nine months ended September 30, 2024, rose by 26% to $6.7 million from$5.4 million in the same period of 2023[104]. - Total operating expenses for the nine months ended September 30, 2024, were $11.3 million, a 20$9.5 million in the same period of 2023[103]. - Cumulative losses as of September 30, 2024, amounted to approximately $64.5 million, with no revenue generated from operations[105]. - As of September 30, 2024, the company had working capital of$2.7 million, primarily consisting of $5.8 million in cash[107]. - Net cash used in operating activities for the nine months ended September 30, 2024, was$8.1 million, compared to $5.6 million for the same period in 2023[108]. Accounting and Regulatory Updates - The FASB issued ASU 2023-09, effective for fiscal years beginning after December 15, 2024, which expands income tax disclosures[120]. - The company is currently evaluating the effect of the new accounting pronouncement on its disclosures[120]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[121].