STATEN ISLAND, N.Y., March 13, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. $(ACXP)$ ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results for the full year and fourth quarter ended December 31, 2025.

Highlights of the fourth quarter ended December 31, 2025, or in some cases shortly thereafter, include:

   -- In October 2025, the Company received gross proceeds from the exercise of 
      170,068 Series F Warrants of approximately $1.4 million. 
 
   -- Also in October 2025, we were one of five companies to make a formal 
      presentation at IDWeek in Atlanta at the session entitled New 
      Antimicrobials in the Pipeline. Presenting on behalf of Acurx were Dr. 
      Michael Silverman, our Medical Director, and Dr. Kevin Garey, Professor 
      and Chair, University of Houston College of Pharmacy and the Principal 
      Investigator for microbiology and microbiome aspects of the ibezapolstat 
      clinical trial program. The Company's presentation included an update 
      on ibezapolstat and its microbiome sparing properties. Also, presented 
      were new colonic-microbiome data from a "state-of-the-art" mouse 
      infection model showing a potential microbiome-sparing class effect of 
      representative compounds from our DNA pol IIIC inhibitor preclinical 
      pipeline. 
 
   -- In November 2025, the Company announced that the Nature Communications 
      Scientific Journal published results from its scientific collaboration 
      with Leiden University Medical Center (LUMC) demonstrating structural 
      biology research that reveals for the first time a DNA pol IIIC inhibitor, 
      ibezapolstat, bound to its target. The publication is entitled: "A unique 
      inhibitor conformation selectively targets the DNA polymerase PolC of 
      Gram-positive priority pathogens." This is an important milestone in 
      Acurx's highly productive scientific collaboration with LUMC in advancing 
      development of these "new-to-nature" compounds fortifying the foundation 
      for the rational development of this innovative class of antimicrobials 
      against other Gram-positive priority pathogens. 
 
   -- In February 2026, we announced that the USPTO granted a new patent for 
      our Pol IIIC inhibitors covering composition of matter and method of use. 
      This patent extends to December 2039, subject to extension under US 
      patent rules. 
 
   -- On March 9, 2026 we issued a press release announcing that we are 
      launching a ground-breaking ibezapolstat clinical trial program in 
      patients with recurrent CDI (or rCDI) that has the potential to shift the 
      paradigm of treatment and prevention of rCDI from two agents to one. When 
      coupled with ibezapolstat ("IBZ") Phase 2 results of being highly 
      effective (96% clinical cure of 26 patients) in treating acute CDI with 
      no recurrence in patients while sparing the gut microbiome, this new 
      trial will position ibezapolstat as a candidate to be the first agent to 
      demonstrate clinical success in both the treatment of CDI and the 
      prevention of rCDI. 
 
   -- This new clinical trial in rCDI begins with an open-label pilot trial to 
      gain experience with IBZ in patients with multiply-recurrent CDI with at 
      least 3 episodes of CDI within the past 12 months. This will inform 
      elements of a planned active-controlled, Phase 3 registration trial in 
      the rCDI indication to be implemented following favorable results from 
      the open-label 20 patient trial. Upon subsequent successful completion of 
      the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx 
      plans to request FDA approval for treatment and prevention of rCDI under 
      the FDA's Limited Population Pathway for Antibacterial and Antifungal 
      Drugs Guidance for Industry published in 2020). 
 
   -- Acurx's clinical program in the broader CDI patient population is ready 
      to Advance to Phase 3 international pivotal clinical trials. In this 
      regard, we are very excited about the FDA's recent announcement published 
      in the New England Journal of Medicine '...that a one-trial requirement 
      will be FDA's new default standard [that is, for registration]'. If 
      formalized, this would end the long-standing two-trial Phase 3 trial 
      dogma. We look forward to FDA's further clarification and the potentially 
      favorable implications to our clinical development programs, such as the 
      opportunity to seek marketing approval for the broader CDI population 
      with one pivotal clinical trial. 

Full Year and Fourth Quarter and 2025 Financial Results

Cash Position:

The Company ended the quarter with cash totaling $7.6 million, compared to $3.7 million as of December 31, 2024. During the fourth quarter, the Company raised a total of approximately $1.5 million of gross proceeds through purchases under the Equity Line of Credit, with gross proceeds of purchases under the Equity Line of Credit totaling approximately $4.0 million for the full year.

R&D Expenses:

Research and development expenses for the three months ended December 31, 2025 were $0.3 million compared to $0.8 million for the three months ended December 31, 2024, a decrease of $0.5 million. The decrease was due primarily to a decrease in manufacturing costs of $0.2 million, and a decrease in consulting costs of $0.3 million as a result of the prior year trial-related expenses. For the twelve months ended December 31, 2025, research & development expenses were $1.8 million versus $5.4 million for the twelve months ended December 31, 2024. The decrease of $3.6 million was primarily due to a reduction of $2.6 million in manufacturing costs, and a $1.0 million decrease in consulting costs as prior year had higher expenses related to Phase 2b and Phase 3 preparation costs.

G&A Expenses:

General and administrative expenses for the three months ended December 31, 2025 were $1.3 million compared to $2.0 million for the three months ended December 31, 2024, a decrease of $0.7 million. The decrease was primarily due to a $0.3 million decrease in compensation-related costs and a $0.3 million decrease in professional fees. For the twelve months ended December 31, 2025, general & administrative expenses were $6.3 million versus $8.7 million for the twelve months ended December 31, 2024, a decrease of $2.4 million. The decrease was primarily due to a $0.9 million decrease in professional fees and a $1.4 million decrease in share-based compensation and a $0.4 million decrease in compensation costs, offset by a $0.3 million increase in legal costs.

Net Income/Loss:

The Company reported a net loss of $1.6 million or $0.73 per diluted share for the three months ended December 31, 2025 compared to a net loss of $2.8 million or $3.29 per diluted share for the three months ended December 31, 2024, and a net loss of $8.0 million or $5.32 per diluted share for the twelve months ended December 31, 2025, compared to a net loss of $14.1 million or $17.45 per share for the twelve months ended December 31, 2024, all for the reasons previously mentioned.

The Company had 2,348,113 shares outstanding as of December 31, 2025.

Conference Call

As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:

 
Date:              Friday, March 13, 2026 
Time:              8:00 a.m. ET 
Toll free (U.S.):  1-877-790-1503; Conference ID: 13758852 
International:     Click here for participant international Toll-Free access 
                   numbers 
                   https://www.incommconferencing.com/international-dial-in 
 

About Ibezapolstat

Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS$(R)$ ) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome. Acurx previously announced that it had received positive regulatory guidance from the EMA during its Scientific Advice Procedure which confirmed that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted to EMA supports advancement of the ibezapolstat Phase 3 program and if the Phase 3 program is successful, supports the submission of a Marketing Authorization Application $(MAA)$ for regulatory approval in Europe. The information package submitted to EMA by the Company to which agreement has been reached with EMA included details on Acurx's two planned international Phase 3 clinical trials, 1:1 randomized (designed as non-inferiority vs vancomycin), primary and secondary endpoints, sample size, statistical analysis plan and the overall registration safety database. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program

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March 13, 2026 07:01 ET (11:01 GMT)