Workflow
Acurx Pharmaceuticals(ACXP) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2022 with cash totaling $10.6 million, down from $13 million as of December 31, 2021 [13] - Research and development expenses for Q3 2022 were $1.6 million, an increase from $1.1 million in Q3 2021, primarily due to Phase 2b trial costs [13] - General and administrative expenses for Q3 2022 were $2 million, down from $3.5 million in Q3 2021, mainly due to reduced share-based compensation and legal fees [14] - The company reported a net loss of $3.5 million or $0.32 per diluted share for Q3 2022, compared to a net loss of $4.6 million or $0.46 per diluted share for Q3 2021 [15] Business Line Data and Key Metrics Changes - The Phase 2b clinical trial for ibezapolstat, the leading antibiotic candidate, is ongoing with 64 patients targeted for enrollment, and currently, 24 sites are open for enrollment [5][6] - The company expanded the number of clinical trial sites from 8 to up to 30 due to slower than expected enrollment [6][11] Market Data and Key Metrics Changes - The company is actively involved in R&D collaborations, including with Leiden University Medical Center, to evaluate the mechanism of action of its antibiotic candidates [7] - Acurx is also focusing on the treatment of MRSA infections, with preclinical data presented at scientific conferences [9] Company Strategy and Development Direction - The company aims to complete lead optimization and conduct manufacturing scale-up for its second antibiotic program targeting MRSA, with plans to submit an IND application [22] - Acurx is pursuing a non-dilutive grant of up to $16 million to support its second antibiotic program, with a decision expected in April 2023 [11][24] Management's Comments on Operating Environment and Future Outlook - Management expressed enthusiasm about the company's fundamentals and progress in Q3 2022, despite challenging times [16] - The company is hopeful about the PASTEUR Act, which could enhance valuations for developers of R&D stage antibiotics [26] Other Important Information - The company recognizes November as C. difficile Awareness Month and supports related foundations [9] - Acurx has presented various aspects of ibezapolstat at prominent scientific conferences, highlighting its favorable killing kinetics compared to standard treatments [8] Q&A Session Summary Question: Update on Phase 2b trial enrollment - The target is 64 patients, and the company plans to announce when 50% enrollment is reached, with potential for early termination if data is favorable [18][20] Question: Path forward for MRSA program - The initial target indication is for abscesses and skin infections caused by MRSA, with plans for both oral and IV formulations [21][22] Question: Update on the PASTEUR Act - The PASTEUR Act is still under consideration, with confidence from industry organizations that it may be approved in the new Congress [25][26]