Acurx Pharmaceuticals(ACXP) - 2021 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Acurx ended Q3 2021 with cash totaling $14.5 million, an increase from $3.2 million as of December 31, 2020, reflecting a cash increase of $17.3 million from the IPO, offset by IPO-related expenditures of $2.5 million and operating expenses of $3.5 million for the nine months ended September 30, 2021 [8][10] - The company reported a net loss of $4.6 million or $0.46 per diluted share for Q3 2021, compared to a net loss of $1.3 million or $0.21 per diluted share for Q3 2020 [10] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2021 were $1.1 million, up from $0.7 million in Q3 2020, primarily due to Phase 2b trial costs [9] - General and administrative expenses for Q3 2021 were $3.5 million, significantly higher than $0.7 million in Q3 2020, mainly due to non-cash stock-based compensation and increased professional fees [9][10] Market Data and Key Metrics Changes - Acurx joined the Russell Microcap Index in September 2021 and participated in several healthcare and investor conferences [6] Company Strategy and Development Direction - The company is focused on advancing its development pipeline of polymerase IIIC inhibitors and has initiated a Phase 2b clinical trial for its lead antibiotic candidate, ibezapolstat, targeting C. difficile infection [2][3] - Acurx is collaborating with Leiden University Medical Center to evaluate the mechanism of action of its pol IIIC inhibitors [6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in meeting the superiority endpoint in the Phase 2b trial, which includes a secondary endpoint related to microbiome restoration compared to vancomycin [14][15] - The company aims to complete enrollment in the Phase 2b trial by Q2 2022, having activated 12 clinical trial sites [24] Other Important Information - Emerging data from the Phase 2a trial indicated favorable microbiome changes and a correlation between secondary bile acids and low risk of reinfection [5][27] - The company is part of the Antimicrobial Working Group to address antimicrobial resistance and promote policy changes [6] Q&A Session Summary Question: Can you discuss the FDA's openness to microbiome data? - Management noted that the FDA is aware of modifications in clinical programs related to the microbiome and that they have a superiority endpoint in their Phase 2b program regarding microbiome restoration [14][15] Question: When do you expect enrollment of the trials to be complete? - Management aims to complete enrollment in the Phase 2b trial by Q2 2022, with a backup plan to activate additional high-enrolling sites if necessary [24] Question: How important is the microbiome and bile acid data to the company? - Management emphasized the significance of microbiome data in demonstrating the efficacy of ibezapolstat compared to vancomycin, particularly in preventing recurrent infections [25][27]