Acurx Pharmaceuticals(US:ACXP)2025-11-12 12:00Antibiotic Development - The company is developing a new class of small molecule antibiotics targeting difficult-to-treat Gram-positive bacterial infections, with a focus on pathogens like MRSA and VRE[97]. - The company believes it is developing the first DNA pol IIIC inhibitor to enter Phase 3 clinical trials, with positive results from its Phase 2 clinical trial for its lead antibiotic candidate, ibezapolstat[100][104]. - The company has an early-stage pipeline of antibiotic candidates, including ACX-375C, targeting Gram-positive bacteria, which has shown proof of concept in animal studies[106]. - The company is evaluating strategic transactions for further development and potential commercialization of ibezapolstat, including partnerships and mergers[107]. Financial Performance - As of September 30, 2025, the company has incurred cumulative losses of approximately $73.7 million since inception[146]. - Research and development expenses for the three months ended September 30, 2025, were $0.4 million, a decrease of 64% compared to $1.2 million for the same period in 2024[137][138]. - General and administrative expenses remained consistent at $1.6 million for the three months ended September 30, 2025, compared to $1.6 million in 2024[139]. - The net loss for the three months ended September 30, 2025, was $2.0 million, a decrease of 29% from $2.8 million in the same period in 2024[140]. - For the nine months ended September 30, 2025, total operating expenses were $6.5 million, a decrease of 43% from $11.3 million in 2024[141]. - The company reported a net loss of $6.4 million for the nine months ended September 30, 2025, down 44% from $11.3 million in 2024[145]. - Net cash used in operating activities was $5.6 million for the nine months ended September 30, 2025, compared to $8.1 million in 2024[151][152]. - Interest income increased significantly to $36,000 for the three months ended September 30, 2025, compared to $5,000 in the same period in 2024, representing a 620% increase[137]. Stock and Compliance - A reverse stock split of 1-for-20 was executed on August 4, 2025, allowing the company to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share[108]. - The company regained compliance with Nasdaq Listing Rule 5550(b)(1) regarding stockholders' equity on August 26, 2025, after addressing previous deficiencies[121]. - The company has increased the total number of authorized shares of common stock from 200 million to 250 million following stockholder approval on September 16, 2025[109]. - The company has sold approximately $3.0 million worth of shares under the purchase agreement with Lincoln Park as of November 11, 2025, out of a total commitment of $12 million[115]. - The company raised net proceeds of approximately $8.8 million under the ATM Program before suspending it in January 2025[146]. - As of September 30, 2025, the company had working capital of $3.6 million, consisting primarily of $5.9 million in cash[149]. Accounting and Regulatory Matters - The company qualifies as an emerging growth company under the JOBS Act, allowing it to delay compliance with new accounting standards until they apply to private companies[161]. - Exemptions under the JOBS Act include not providing an auditor's attestation report on internal controls and certain executive compensation disclosures for five years post-IPO[162]. - The FASB issued ASU 2023-09, effective after December 15, 2024, which expands income tax disclosures, though the company believes it will not materially impact its disclosures[164]. - ASU 2024-03, effective after December 15, 2026, requires more detailed expense information in income statements, with the company currently evaluating its impact[165]. - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[166]. Compensation and Stock Options - Compensation expense related to stock options is recognized over the requisite service period based on the fair value at grant date, influenced by subjective assumptions like expected price volatility[159]. - The company utilizes the Black-Scholes option pricing model for estimating the fair value of options and warrants, with potential impacts on expenses and results of operations from changes in assumptions[160].