Acurx Pharmaceuticals (NASDAQ:ACXP) reported a wider third-quarter net loss as spending rose on its recurrent C. difficile infection trial, while executives outlined two potential paths toward a pivotal study of its antibiotic candidate ibezapolstat.
The company ended September with $9.7 million in cash and said its 20-patient PATHFINDER trial is fully funded. President and CEO David Luci said Acurx expects to update investors when enrollment is complete, potentially in the second half of 2027, depending on the pace of recruitment.
Two potential development paths
Luci said the Food and Drug Administration was open to further discussions at a pre-application meeting about the totality of evidence from a single ASPIRE trial and PATHFINDER. The agency would focus on whether the efficacy data from the two studies were robust enough to support a new drug application, he said.
Acurx is also considering a separate Phase III study, PATHFINDER II, in recurrent infection under the FDA’s limited population pathway for antibacterial and antifungal drugs. Luci said a successful initial PATHFINDER trial could give the company the flexibility to pursue that route instead of ASPIRE for an initial approval. Under that scenario, ASPIRE could become a post-approval supplemental application for a broader patient population.
Funding and trial results will influence the choice, Luci told analysts. If Acurx receives a government grant for ASPIRE, he said, the company is ready to start that trial. If ASPIRE remains unfunded when Acurx meets with the FDA after the initial PATHFINDER study, positive data could support discussions about proceeding with PATHFINDER II.
“We are going to have to continue to ride the two development pathways in parallel until we see how the facts play out,” Luci said.
He cautioned that it was too early to provide firm timing or cost estimates for PATHFINDER II. Depending on the initial trial’s data, the study could enroll approximately 350 patients internationally and take 18 months to two years to fully enroll. It would use an active comparator, with VOWST currently being considered, although that could change, he said.
Quarterly loss widens as research costs rise
Acurx reported a net loss of $2.6 million, or $0.49 per diluted share, for the quarter ended September 30, compared with a loss of $2 million, or $1.23 per diluted share, a year earlier. Research and development expenses increased to $1.1 million from $0.4 million, primarily because of consulting costs associated with the recurrent infection trial program, CFO Rob Shawah said.
General and administrative expenses declined to $1.5 million from $1.6 million. For the first nine months of 2026, the company reported a net loss of $6.5 million, compared with $6.4 million in the same period a year earlier.
Cash at September 30 was up from $7.6 million at the end of 2025. Shawah said Acurx raised approximately $1.5 million in gross proceeds through its equity line of credit during the third quarter. The company had 5,879,237 shares outstanding at quarter-end.
Funding and listing questions
Addressing questions submitted by stakeholders, Luci said Acurx has enough funds to pay for the recurrent infection trial, assuming it is fully enrolled in the third quarter of 2027. He said the company has 12 months of funds secured and could raise additional cash through equity line drawdowns, equity offerings, partnerships or government grants.
Asked about maintaining Nasdaq listing compliance, Luci pointed to trial enrollment, anticipated research announcements and active partnering discussions as potential sources of value. He said partnership discussions had not progressed to the point of public disclosure.
Luci also said a bylaw amendment reduced the quorum required to conduct stockholder business from a majority to 33.33%. He said the change was intended to limit delays when shareholders do not vote and did not alter their right to one vote per share.
Research and intellectual property updates
In August, Acurx received conditional FDA acceptance and U.S. trademark allowance for CIFBEZY as the proposed brand name for ibezapolstat, Luci said. The company also reported new patent grants in Japan and Mexico covering its DNA Pol III inhibitors.
Luci highlighted laboratory research presented during the period, including findings that ibezapolstat showed greater in vitro activity against C. difficile than the standard-of-care antibiotics vancomycin and fidaxomicin in the models studied. He also discussed the continuation of Acurx’s research partnership with Leiden University Medical Center on DNA Pol III inhibitors for drug-resistant Gram-positive pathogens.
About Acurx Pharmaceuticals (NASDAQ:ACXP)
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) is a clinical-stage biopharmaceutical company focused on developing novel antibiotics for serious bacterial infections. The company’s research is centered on therapies designed to address pathogens that are resistant to existing treatments. Acurx’s lead product candidate is ibezapolstat, also known as ACX-375, an investigational oral antibiotic being developed for the treatment of Clostridioides difficile infection, commonly known as C. difficile infection.
