The following is a summary of the Acurx Pharmaceuticals, Inc. (ACXP) Q4 2023 Earnings Call Transcript:
Financial Performance:
Acurx ended the year with cash totaling $7.5 million compared to $9.1 million as of the end of the previous year.
After year-end, the firm generated approximately $4.5 million through its ATM financing program.
Research and development expenses for Q4 2023 and for the year were $1.9 million and $6 million, respectively, primarily due to Phase IIb trial-related costs and an increase in consulting costs.
General and administrative expenses for Q4 2023 and for the year were $3.2 million and $8.5 million, respectively, due to increases in professional fees, share-based compensation, and employee compensation costs.
Acurx reported a net loss of $5.1 million or $0.37 per diluted share for Q4 2023 and a net loss of $14.6 million or $1.15 per share for the year.
Business Progress:
Acurx is advancing ibezapolstat into Phase III clinical trials, the final step to commercialize the antibiotic to treat CDI. It has received FDA Fast Track designation and is projected to significantly reduce the current cost burden of treating C. difficile infection in the U.S. health care system.
The company has submitted a robust pre-clinical and clinical microbiome safety and CMC evidence package to the FDA. Plans will also soon be submitted to the European Medicines Agency (EMA) for conducting Phase III clinical trials in Europe.
Acurx is also seeking strategic transactions, including partnerships for further development, potential sales mergers, and licensing arrangements.
The company ended enrollment for their Phase IIb clinical trial of ibezapolstat, showing positive results with a clinical cure rate of 96% at the end of treatment and no safety concerns.
The company has commenced advance into Phase III clinical trials and is preparing for a FDA meeting regarding readiness to proceed. It is planning to include international sites in these trials to support international regulatory filings for marketing approval.
More details: Acurx Pharmaceuticals IR
Tips: This article is generated by AI. The accuracy of the content can not be fully guaranteed. For more comprehensive details, please refer to the IR website. The article is only for investors' reference without any guidance or recommendation suggestions.