Acurx Pharmaceuticals (NASDAQ:ACXP) reported a smaller first-quarter loss and outlined plans to begin a new clinical trial program for ibezapolstat in recurrent Clostridioides difficile infection, or rCDI, while also highlighting recent regulatory guidance that management said could potentially affect its late-stage development strategy.
On the company’s first-quarter 2026 earnings call, President and Chief Executive Officer David P. Luci said Acurx is starting an ibezapolstat clinical trial program in patients with recurrent CDI that “has the potential to shift the paradigm” from using two agents to a single treatment. Luci said the program builds on prior Phase 2 data in acute CDI, where ibezapolstat showed a 96% cure rate and no recurrent CDI among 25 patients who were cured.
Recurrent CDI trial to start with 20-patient pilot study
Luci said the new recurrent CDI program will begin with an open-label pilot study in patients with multiply recurrent CDI who have had at least three episodes within the past 12 months. The company expects the 20-patient study to help inform elements of a planned active-control Phase 3 registration trial in the recurrent CDI indication.
Executive Chairman Robert J. DeLuccia said during the question-and-answer session that Acurx is currently in startup mode for the rCDI trial, including site qualification visits. He said the company hopes to enroll the first patient “probably” in the August timeframe, while noting that it could potentially happen earlier if the process accelerates.
Management described two potential regulatory pathways for ibezapolstat: one in the broader acute CDI population and a separate path in recurrent CDI under the FDA’s limited population pathway for antibacterial and antifungal drugs, or LPAD. Luci said the acute CDI program is ready to advance to international Phase 3 pivotal clinical trials, while the recurrent CDI effort would begin with the exploratory 20-patient study.
FDA guidance could support single pivotal trial approach
A key topic on the call was recent FDA guidance that management said may allow one adequate and well-controlled trial, supported by confirmatory evidence, to meet the standard for approval in CDI. Luci said the company is “very excited” about the FDA’s recent announcement and looks forward to further clarification on its implications.
DeLuccia said Acurx does not see anything in the new guidance, at first pass, that would require changes to its pivotal trial design, which he said is already agreed to with the FDA. He said the company has scheduled a meeting with the agency to discuss the guidance.
Medical Director Dr. Michael Silverman said the guidance is final rather than draft and applies the single-trial framework specifically to C. difficile infection. He said Acurx believes it has several forms of confirmatory evidence that may support its position, including mechanistic data, in vitro activity, anti-virulence data, animal efficacy data and microbiome data.
Silverman also clarified that the company’s planned 20-patient recurrent CDI study is distinct from the potential single pivotal Phase 3 trial in acute CDI, which would involve patients with a single episode or no more than one recurrence.
Microbiome preservation remains central to development strategy
In response to an analyst question, Silverman said microbiome assessment is “key” to Acurx’s program, although he cautioned that it is currently an ancillary or exploratory marker rather than something expected to support an initial approvable claim.
Silverman said antibiotic treatment for CDI can alter gut bacteria, including bacteria that contribute to bile acid metabolism and help suppress the growth of C. difficile. He said Acurx’s work with Dr. Kevin Garey at the University of Houston suggests ibezapolstat and related compounds are gentler on the microbiome than drugs such as vancomycin.
“Those bacteria that are producing the bile acids that suppress the growth of C. difficile are maintained, and we believe that’s a main feature in reducing recurrence,” Silverman said.
Silverman said Acurx plans to follow patients for one month after treatment in Phase 3 to assess recurrence, consistent with existing standards, and also intends to follow them for an additional month. He said the two-month follow-up aligns with recurrence-reduction claims for live biological products VOWST and REBYOTA.
First-quarter financial results
Chief Financial Officer Rob Shawa said Acurx ended the first quarter with $9.3 million in cash, compared with $7.6 million as of Dec. 31, 2025. During the quarter, the company raised approximately $3.1 million in gross proceeds through purchases under its equity line of credit.
Research and development expenses were $0.3 million for the three months ended March 31, 2026, down from $0.6 million in the prior-year period. Shawa said the decrease was primarily due to a $0.1 million reduction in manufacturing costs and a $0.2 million reduction in consulting-related costs tied to prior-year trial preparation expenses.
General and administrative expenses were $1.4 million, compared with $1.6 million a year earlier. The decrease was attributed mainly to lower professional fees and legal costs.
Acurx reported a net loss of $1.7 million, or $0.62 per diluted share, for the first quarter, compared with a net loss of $2.1 million, or $2.15 per diluted share, in the first quarter of 2025. The company had 3,389,106 shares outstanding as of March 31, 2026.
Financing, patents and preclinical data
Luci said Acurx closed a registered direct offering on April 16 involving 825,085 shares of common stock or pre-funded warrants at $3.03 per share or warrant. In a concurrent private placement, the company issued unregistered short-term warrants to purchase up to 1,650,170 shares of common stock at an exercise price of $2.78 per share. Luci said the related resale registration statement is now effective.
According to Luci, that financing, combined with remaining availability under Acurx’s equity line of credit, provides the company with the resources to conduct the exploratory recurrent CDI clinical trial.
Acurx also highlighted additions to its intellectual property portfolio. Luci said the Korean Intellectual Property Office granted a new patent covering DNA polymerase IIIC inhibitors, including compositions of matter, methods of use and pharmaceutical compositions. He said the company has secured 10 patents to date, including five in the U.S. and patents in Israel, Japan, India, Australia and Korea. Luci also noted that the U.S. Patent and Trademark Office granted a new patent in February covering DNA Pol IIIC inhibitors, extending to December 2039, subject to potential extension under U.S. patent rules.
The company also presented preclinical microbiome data on new systemically absorbed DNA Pol IIIC compounds at the ESCMID Global scientific conference in Munich. Luci said the compounds achieved potentially therapeutic plasma levels and reduced MRSA tissue burden while maintaining high gut microbial diversity similar to baseline and distinct from linezolid.
Luci said Acurx continues to pursue funding opportunities for its Phase 3 ibezapolstat program in acute CDI and will provide future updates as those initiatives progress.
About Acurx Pharmaceuticals (NASDAQ:ACXP)
Acurx Pharmaceuticals, Inc, headquartered in King of Prussia, Pennsylvania, is a clinical‐stage biopharmaceutical company focused on the discovery and development of novel anti‐infective therapies. The company’s research platform leverages insights into bacterial virulence regulation and quorum sensing pathways to design small-molecule candidates aimed at reducing pathogen toxicity and biofilm formation. By targeting key mechanisms of infection rather than bacterial viability alone, Acurx seeks to offer differentiated treatment options that may help address the growing challenge of antibiotic resistance.
Acurx’s lead product candidates are being developed to treat acute bacterial skin and skin structure infections (ABSSSI), including cases caused by drug-resistant strains such as methicillin-resistant Staphylococcus aureus (MRSA).
