Acurx Pharmaceuticals(US:ACXP)2023-08-10 16:00Antibiotic Development - The Company is developing a new class of antibiotics targeting priority pathogens identified by WHO, CDC, and FDA, addressing the global crisis of antimicrobial resistance [77]. - The lead antibiotic candidate, ibezapolstat, demonstrated a 100% response rate in the Phase 2a clinical trial, with all 10 patients achieving Clinical Cure and no serious adverse events reported [83]. - The Phase 2b clinical trial for ibezapolstat commenced enrollment on December 3, 2021, with 31 patients currently enrolled and an Independent Data Monitoring Committee set to review interim data [86]. - The Referring Physician Program launched in July 2022 aims to enhance patient enrollment in the Phase 2b clinical trial, targeting high-prescribing physicians within a 25-mile radius of trial sites [87]. - The Company increased the number of clinical trial sites for the Phase 2b trial from 12 to 28 to optimize patient enrollment [90]. - The Company’s early-stage pipeline includes ACX-375C, targeting Gram-positive bacteria, including MRSA and VRE, with established proof of concept in animal studies [84]. - The Company’s protocol amendment accepted by the FDA allows for interim clinical data review by an Independent Data Monitoring Committee [86]. - The CDC estimates that antibiotic-resistant pathogens infect one individual every 11 seconds in the U.S., highlighting the urgency of developing new antibiotics [77]. Financial Performance - The company reported a net loss of $3.4 million for the three months ended June 30, 2023, compared to a net loss of $2.6 million for the same period in 2022, representing a 31% increase in net loss [119]. - Research and development expenses increased to $1.7 million for the three months ended June 30, 2023, up 90% from $0.9 million in the same period in 2022, primarily due to Phase 2b clinical trial costs [118]. - Total operating expenses for the three months ended June 30, 2023, were $3.4 million, a 31% increase from $2.6 million in the same period in 2022 [116]. - For the six months ended June 30, 2023, research and development expenses were $2.8 million, a 59% increase from $1.7 million in the same period in 2022 [121]. - The company has incurred cumulative losses of approximately $44.9 million as of June 30, 2023, with no revenue generated since inception [123]. - As of June 30, 2023, the company had working capital of $6.2 million, consisting primarily of $9.1 million in cash [124]. - The company completed a registered direct offering on May 18, 2023, resulting in net proceeds of approximately $3.5 million after deducting placement agents fees and offering costs [123]. - General and administrative expenses remained stable at $1.7 million for the three months ended June 30, 2023, compared to the same period in 2022 [118]. - The company anticipates increased general and administrative expenses in the future to support ongoing research and development activities [114]. - The company has funded its operations primarily through equity issuances, including net cash proceeds of approximately $14.8 million from its IPO on June 29, 2021 [123]. - Net cash used in operating activities was $3.5 million for the six months ended June 30, 2023, an increase from $3.9 million in the same period of 2022 [126][127]. - The net loss for the six months ended June 30, 2023, was greater than the net cash used in operating activities by $2.8 million, primarily due to share-based compensation and vendor payments [126]. - Net cash provided from financing activities was $3.5 million for the six months ended June 30, 2023, attributed to net proceeds from a registered direct offering [127]. - Share-based compensation and vendor payments accounted for $1.7 million in both periods, indicating a consistent expense level [126]. Accounting and Compliance - The company expenses research and development costs when incurred, with cash advances deferred until services are provided [130]. - The company utilizes estimates based on historical experience and known trends for accrued expenses and stock-based compensation, which may differ from actual results [128]. - The company is classified as an emerging growth company under the JOBS Act, allowing it to delay adopting new accounting standards [135][136]. - Recent accounting pronouncements are not expected to significantly impact the company's financial measurements or disclosures [137].