Acurx Pharmaceuticals, Inc. Reports Full Year and Fourth Quarter Results and Provides Business Update

STATEN ISLAND, N.Y., March 13, 2026 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: 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:

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^®) 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

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Acurx Pharmaceuticals, Inc. 

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin- resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE), drug- resistant Streptococcus pneumoniae (DRSP) and B. anthracis (anthrax; a Bioterrorism Category A Threat-Level pathogen).

Acurx's lead product candidate, ibezapolstat, for the treatment of C. difficile Infection(CDI) is Phase 3 ready to advance to international clinical trials subject to obtaining appropriate financing.The Company recently announced the launch of a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one. 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, 2020).

The Company's preclinical pipeline includes development of an oral product candidate for treatment of ABSSSI (Acute Bacterial Skin and Skin Structure Infections), upon which a development program for treatment of inhaled anthrax is being planned in parallel.

To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com. 

Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether ibezapolstat will benefit from the QIDP designation; whether ibezapolstat will advance through the clinical trial process on a timely basis; whether the results of the clinical trials of ibezapolstat will warrant the submission of applications for marketing approval, and if so, whether ibezapolstat will receive approval from the FDA or equivalent foreign regulatory agencies where approval is sought; whether, if ibezapolstat obtains approval, it will be successfully distributed and marketed; and other risks and uncertainties described in the Company's annual report filed with the Securities and Exchange Commission on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent filings with the Securities and Exchange Commission. Such forward- looking statements speak only as of the date of this press release, and Acurx disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements, except as may be required by law.

Investor Contact:

Acurx Pharmaceuticals, Inc.
David P. Luci
President & Chief Executive Officer
Tel: 917-533-1469
Email: [email protected]

SOURCE Acurx Pharmaceuticals, Inc.