Acurx Pharmaceuticals, Inc. Q4 FY2025 earnings call

In October 2025, the company received gross proceeds of approximately $1.4 million from the execution of 170,000 Series F warrants. Also in October, it made a formal presentation at ID Week in Atlanta. In November 2025, the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center. On March 9, 2026, the company announced launching a groundbreaking Ibenzapolistat clinical trial program in patients with recurring CDI. In February 2026, the U.S. Patent and Trademark Office granted a new patent for its Call 3C inhibitors. It continues to identify and pursue funding opportunities for its Phase III clinical trial programs for IBEZA-POLSTAT and considers alternative financial pathways.

Continue to identify and pursue funding opportunities for the Phase III clinical trial programs for IBEZA-POLSTAT and consider alternative financial pathways to achieve success.

Forward-looking statements are subject to change and involve risks and uncertainties that may cause actual results to differ materially. Also face challenges in the macroeconomic environment and in the industry sector.

Q: Starting with the new recurrent CDI trial, for the primary endpoint for, I'm assuming, is prevention of recurrence, how far out do you have to go? Is it three months, six months, one month? and so on, and what is the cost of that trial?

A: Following the end of treatment, the first endpoint for recurrent disease is eight weeks, and they will continue to follow patients out for approximately six months after the endotherapy. The cost is in the range of $4 to $5 million.

Q: If this pilot is successful, does it change – and you're starting to think about recurrent CDI for the phase three, does that change the size, the potential size of a phase three?

A: It depends upon what is seen in the open label trial. Based on reasonable assumptions, currently projecting somewhere between 360 and 400 patients for a single trial in the recurrent CDI indication.

Q: You had mentioned U.S.-based manufacturing, which seems to be a very important issue these days with the current administration. Is that something that you're really trying to make headway with regulators on or the current administration in terms of having ideas.

A: Continuing to have detailed discussions with government agencies, including BARDA, and it's important to them in their consideration of a public-private partnership that the program be made in America.

Q: In the March 9th press release, you said the First patient here in the phase two, fourth quarter 26. Should we take regularly 12 to 18 months after the fourth quarter of this year for this phase two to fully enroll?

A: Sometime in the fourth quarter plus 12 to 15 months.

Q: Speaking with a number of other companies who've gone in front of the FDA, a lot of things have been said about trying to speed things up and make some changes to the clinical trial procedure. But some of these other companies I've spoken with have not found really much difference when they actually approach the FDA. They still are facing the folks, same people beneath. It may be early to say, but how real do you think the one trial might be?

A: Pretty encouraged that it's going to be a game changer. One of the scientific advisors is the former head of the antimicrobials division at the FDA. They need to formalize it and are working on a guidance for industry. We're poised and ready to talk to FDA at the appropriate time.