Acurx Pharmaceuticals(US:ACXP)2023-05-12 14:33Financial Data and Key Metrics Changes - The company ended Q1 2023 with cash totaling $7.2 million, down from $9.1 million as of December 31, 2022 [15] - Research and development expenses for Q1 2023 were $1 million, an increase from $800,000 in Q1 2022, attributed to Phase 2b trial costs [15] - General and administrative expenses remained flat at $1.9 million for both Q1 2023 and Q1 2022 [15] - The company reported a net loss of $2.9 million or $0.25 per diluted share for Q1 2023, compared to a net loss of $2.7 million or $0.26 per diluted share for Q1 2022 [15] Business Line Data and Key Metrics Changes - The Phase 2b clinical trial for ibezapolstat is ongoing, with an increase in trial sites from 12 to 28 due to slower-than-expected patient enrollment [5][6] - The primary endpoint of the trial is clinical cure at the end of treatment, with a secondary endpoint of sustained clinical cure at day 38 [5] Market Data and Key Metrics Changes - The company is actively pursuing funding from CARB-X for its second antibiotic candidate targeting MRSA infections, with a decision expected by October 2023 [11][12] - The company is also involved in a research collaboration with Leiden University Medical Center, supported by a grant from the Dutch government [10] Company Strategy and Development Direction - The company is focused on advancing its antibiotic pipeline, particularly ibezapolstat, which aims to treat C. difficile infections while managing the microbiome [7][8] - The company is optimistic about the potential impact of the PASTEUR Act on antibiotic development and funding for clinical trials [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase 2b trial, noting exceptional blinded data with high cure rates [28][32] - The company anticipates completing enrollment of 36 patients in the second half of 2023, with a conservative approach to timelines [21] Other Important Information - The company presented at the ECCMID Conference in April 2023, highlighting the unique mechanism of action of ibezapolstat [8][9] - The company is awaiting a decision on a non-dilutive grant application to CARB-X, which could provide significant funding for its antibiotic programs [11][12] Q&A Session Summary Question: What are the major factors behind the change in the interim analysis timeline for the Phase 2b study? - Management indicated that the timeline was adjusted to provide a conservative cushion, with expectations for completion in the second half of 2023 [21] Question: What other efficacy endpoints can investors look for in the interim analysis? - Management expects to see efficacy rates between 90% and 100%, based on previous trial data [22][23] Question: Can you elaborate on the exceptional blinded data mentioned? - Management reported almost all cures observed in the blinded data, indicating strong efficacy [28] Question: What are the unique challenges faced in the Phase 2b recruitment compared to Phase 2a? - Challenges include changes in clinical trial culture post-COVID, requiring patients to travel to trial sites quickly after diagnosis [36][44] Question: What does "active review" mean in the context of CARB-X funding? - Management explained that active review indicates the application is still under consideration, with most candidates typically facing rejection [38] Question: What should be monitored regarding the PASTEUR Act? - Management noted that the expectation is for the Act to be included in legislation by the end of Q3, with potential funding implications for antibiotic development [39]