Acurx Pharmaceuticals (ACXP) Q3 2026 Earnings Report

The call was predominantly positive, centered on the start of the fully funded PATHFINDER trial, favorable preclinical and microbiome findings, FDA openness to further discussions regarding a potential NDA pathway, expanded intellectual property, and sufficient funding for the current recurrent CDI trial. The main challenges were higher R&D spending, continued net losses, dependence on future funding and clinical data to determine the Phase III pathway, unresolved partnership activity, NASDAQ listing compliance efforts, and the expected timing of a recurrent CDI trial update in the second half of 2027.

Management said the FDA is open to further discussion at a pre NDA meeting after completion of the single Phase III ASPIRE trial and data from the 20-patient Pathfinder trial, and that a successful Pathfinder trial may support a smaller Phase III program or Pathfinder 2 under the FDA’s LPAD pathway. Acurx said it has enough funds to pay for the rCDI trial, assuming the trial is fully enrolled in the third quarter of 2027, has 12 months of funds secured, and may raise cash in the next 12 months through ELOC drawdowns, equity offerings, partnerships or government grants; an update is expected when enrollment is completed sometime in the second half of 2027. If the ASPIRE trial receives a government grant, the company said it would start that trial right away; if it is not funded and rCDI data is good, FDA may give the green light to continue with Pathfinder 2. Depending on data from the 20 patient trial, Pathfinder 2 may be in the neighborhood of 350 patients in total, may take 1.5 or 2 years to fully enroll, would be an international study, and would use an active comparator currently considering VOWST as a lead possibility.