Acurx Pharmaceuticals (ACXP) Q2 FY26 earnings call: guidance and Q&A

Does the company have enough API for PATHFINDER and ASPIRE trials, and what is the status of ibezapolstat manufacturing?

The company has plenty of API and formulated product ready for the PATHFINDER trial. They are also poised to have enough API manufacturing with appropriate dating for the ASPIRE trial.

“We stand on -- and we have plenty of API and also the formulated product is all ready to go to support the PATHFINDER trial, and we're poised to have enough API manufacturing with appropriate dating to start the ibezapolstat ASPIRE trial as well.”

asked by Matthew Keller · answered by Robert DeLuccia

What geographies are being considered for the international ASPIRE trial, and have activities begun in those regions?

Western and Eastern Europe are being considered. Screening has not yet begun, but the trial will include countries with a high incidence of C. difficile infection.

“Well, the plans in international. I don't have my finger on the pulse of every country that we've considered, but certainly Western and Eastern Europe.”

asked by Matthew Keller · answered by Michael Silverman

What criteria would constitute "robust enough data" for FDA approval, particularly regarding reduction of remission, based on interactions with the FDA?

Robustness involves two categories: good clinical practices (high-quality data, minimization of protocol violations, missing data) and inherent drug properties (consistency of efficacy across endpoints, sites, countries). Patient population must be representative of US patients. Measuring patients 8 weeks post-treatment in the ASPIRE trial for no reinfection in those with 3+ prior episodes would be persuasive.

“I like to think about it, the support of robustness in 2 general categories. One is what are these items that we would naturally build into a clinical trial, good clinical practive, high-quality data, minimization of protocol violations, minimization of missing data, those sorts of things to ensure that the data are trustworthy.”

asked by James Molloy · answered by Michael Silverman

What is the target for ibezapolstat's performance relative to vancomycin for FDA approval?

The ASPIRE trial is a non-inferiority trial, not a superiority trial. The goal is to show non-inferiority to vancomycin for the acute treatment endpoint, with a lower limit of the confidence interval within 10%.

“This is not a superiority trial. This is a noninferiority trial. So we don't have to show superiority over vancomycin for the clinical care acute treatment endpoint. We need to show noninferiority within standard bonds, which is a statistical concept but the lower limit would be confidence interval within 10%.”

asked by James Molloy · answered by Michael Silverman

How critical is PATHFINDER data for securing funding for the ASPIRE Phase III trial, and are there other potential approval pathways?

PATHFINDER data is considered "quite important" for potential partnerships to fund ASPIRE. If PATHFINDER is successful, there's a second pathway to FDA approval under the LPAD pathway for recurrent C. diff, which could allow for approval with just one Phase III trial (potentially half the cost of ASPIRE).

“We think that's quite important. And we're heartened by the FDA's enthusiasm with our being willing to conduct that trial. Now interestingly, whether or not the ASPIRE trial is eventually funded, there's a second pathway to FDA approval under the LPAD pathway for recurrent C diff.”

asked by James Molloy · answered by David Luci