Acurx Pharmaceuticals (NASDAQ:ACXP) reported a second-quarter net loss of $2.3 million, or $0.53 per diluted share, while outlining plans to begin enrollment in its 20-patient IBZ-PATHFINDER study of ibezapolstat in recurrent Clostridioides difficile infection, or CDI, during the fourth quarter of 2026.
The company ended the quarter ended June 30 with $10.7 million in cash, compared with $7.6 million at Dec. 31, 2025. Chief Financial Officer Rob Shawah said the company raised approximately $2.5 million in gross proceeds through a registered direct offering during the quarter, along with $0.8 million through its equity line of credit.
FDA Discusses Single Phase III Trial Path
President and CEO Dave Luci said Acurx met with the Food and Drug Administration in July to discuss whether a single Phase III study in acute CDI could serve as a pivotal trial for a New Drug Application.
According to Luci, the FDA said it is open to discussing the totality of evidence from the ibezapolstat development program at a pre-NDA meeting following completion of the IBZ-ASPIRE trial and other studies conducted beforehand. Those studies include the open-label PATHFINDER trial in patients with mostly recurrent CDI, particularly if clinical efficacy results are robust.
The company expects PATHFINDER enrollment to begin in the fourth quarter. Luci said the study, together with results from ASPIRE, could support a potential approval for CDI treatment and prevention of recurrent CDI.
During the question-and-answer session, Medical Director Dr. Michael Silverman said Acurx’s definition of robust data includes high-quality trial execution, limited protocol violations and missing data, as well as consistency of efficacy results across endpoints, trial sites and countries. He also said the company intends for the international trial population to be representative of patients seen in the United States.
Silverman said IBZ-ASPIRE is designed as a non-inferiority study versus vancomycin for the acute-treatment clinical-cure endpoint. The company does not need to demonstrate superiority over vancomycin for that endpoint, he said, adding that the lower limit of the confidence interval would need to remain within 10% under the non-inferiority framework.
Luci said the ASPIRE design would measure patients eight weeks after the end of treatment. He said the company believes a lack of reinfection at that point among patients with three or more prior episodes in the preceding year could be persuasive to the FDA.
PATHFINDER Could Support Funding and Alternative Regulatory Route
Management characterized PATHFINDER data as important to potential partnership discussions and financing for the larger Phase III program. Luci also said the company could pursue a separate pathway for recurrent CDI under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD, depending on results and FDA discussions after the exploratory study.
Under that potential route, Luci said Acurx could seek approval in recurrent CDI with one Phase III trial. He said such a study could cost roughly half as much as one of the company’s planned ASPIRE trials.
Executive Chairman Bob DeLuccia said Acurx has sufficient active pharmaceutical ingredient and formulated product to support PATHFINDER. He also said the company is positioned to have sufficient appropriately dated API to begin the ASPIRE study.
DeLuccia said the international ASPIRE trial is expected to include Western and Eastern Europe, among other countries with generally high incidences of CDI, although the company has not begun screening participants.
Brand Name, Research Partnerships and Preclinical Work
Acurx said it received FDA conditional acceptance and U.S. Patent and Trademark Office trademark allowance for Syfbezi as the proprietary name for ibezapolstat. Luci said the designation is intended to form the basis of the product’s commercial identity as the company advances its registration program.
The company also announced a continuation of its scientific partnership with Leiden University Medical Center to study its DNA Pol IIIC inhibitors. The work is intended to further research into DNA Pol IIIC inhibition and support development of antibiotics targeting resistant gram-positive pathogens.
Luci said the partnership aims to generate what the company described as the first 3D structure of PolC from methicillin-resistant Staphylococcus aureus in complex with an Acurx inhibitor.
Separately, Acurx cited July data presented by Dr. Kevin Garey and his University of Houston College of Pharmacy laboratory. The company said ibezapolstat allowed beneficial gut microorganisms to repopulate the microbiome in a laboratory model, while ibezapolstat and fidaxomicin were superior in biofilm models. Acurx said ibezapolstat was significantly more effective at killing C. difficile than vancomycin and fidaxomicin in those experimental models.
Quarterly Expenses and Loss
Research and development expense rose to $1.1 million in the second quarter from $0.5 million a year earlier, driven primarily by $0.3 million increases in manufacturing costs and consulting costs related to the recurrent CDI trial program.
General and administrative expense declined to $1.2 million from $1.7 million in the prior-year quarter. Shawah attributed the reduction primarily to lower professional fees, legal costs and share-based compensation expense.
For the first six months of 2026, Acurx reported a net loss of $3.9 million, or $1.13 per diluted share, compared with a net loss of $4.4 million, or $4.01 per diluted share, in the first half of 2025. The company had 4,683,253 shares outstanding as of June 30.
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).
