STATEN ISLAND, N.Y., Nov. 12, 2025 /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 third quarter ended September 30, 2025.
Highlights of the third quarter ended September 30, 2025, or in some cases shortly thereafter, include:
-- On August 4, 2025, we effected a 1-for-20 reverse stock split of our
issued and outstanding shares of common stock, and as a result of the
reverse-stock-split, on August 26, 2025, we regained compliance with the
minimum bid price requirement of $1.00 per share under the Nasdaq Listing
Rules. In addition, we met the minimum stockholders' equity threshold of
$2.5 million under Nasdaq Listing Rules. We are now in full compliance
with all Nasdaq continued listing requirements and our common stock will
remain listed and traded on the Nasdaq Stock Market.
-- In September 2025, the Australian Patent Office granted a new patent for
the Company's class of DNA polymerase IIIC inhibitors, including
composition of matter. To date, Acurx has obtained three U.S. patents,
one Israeli patent, one Japanese patent, one Indian patent, and now the
Australian patent, in each case, which cover the ACX-375C program,
relating to DNA Pol IIIC Inhibitors for infections caused by
Gram-positive bacteria including MRSA, VRE and PRSP, with other
country-level filings in process.
-- Also in September 2025, at our special meeting of stockholders, our
stockholders approved an amendment to our Certificate of Incorporation,
to increase the total number of authorized shares of our common stock
from 200,000,000 to 250,000,000... in late September, we filed the
Amendment with the Secretary of State of the State of Delaware with
immediate effect.
-- 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.
Third Quarter 2025 Financial Results
Cash Position:
The Company ended the quarter with cash totaling $5.9 million, compared to $3.7 million as of December 31, 2024. During the third quarter, the Company raised a total of approximately $1.7 million of gross proceeds through purchases under the Equity Line of Credit. In addition, after quarter end, the Company raised an additional $1.4 million from a warrant exercise by one institutional investor.
R&D Expenses:
Research and development expenses for the three months ended September 30, 2025 were $0.4 million compared to $1.2 million for the three months ended September 30, 2024, a decrease of $0.8 million. The decrease was due primarily to a decrease in manufacturing costs of $0.1 million, and a decrease in consulting costs of $0.7 million as a result of the prior year trial related expenses. For the nine months ended September 30, 2025, research & development expenses were $1.6 million versus $4.6 million for the nine months ended September 30, 2024. The decrease of $3.0 million was primarily due to a reduction of $0.7 million in manufacturing costs, and a $2.3 million decrease in consulting costs due to higher trial related costs in the prior year.
G&A Expenses:
General and administrative expenses for the three months ended September 30, 2025 were $1.6 million compared to $1.6 million for the three months ended September 30, 2024. The expenses remained relatively consistent as a $0.2 million decrease in compensation related costs were offset by a $0.1 million increase in legal fees. For the nine months ended September 30, 2025, general & administrative expenses were $4.9 million versus $6.8 million for the nine months ended September 30, 2024, a decrease of $1.9 million. The decrease was primarily due to a $0.6 million decrease in professional fees and a $1.3 million decrease in share-based compensation.
Net Income/Loss:
The Company reported a net loss of $2.0 million or $1.23 per diluted share for the three months ended September 30, 2025 compared to a net loss of $2.8 million or $3.45 per diluted share for the three months ended September 30, 2024, and a net loss of $6.4 million or $5.01 per diluted share for the nine months ended September 30, 2025, compared to a net loss of $11.3 million or $14.23 per share for the nine months ended September 30, 2024, all for the reasons previously mentioned.
The Company had 1,800,299 shares outstanding as of September 30, 2025.
Conference Call
As previously announced, David P. Luci, President and Chief Executive Officer, and Robert G. Shawah, Chief Financial Officer, will host a conference call to discuss the results and provide a business update as follows:
Date: Wednesday, November 12, 2025
Time: 8:00 a.m. ET
Toll free (U.S.): 1-877-790-1503; Conference ID: 13756868
International: Click here for participant international Toll-Free access
numbers
https://www.incommconferencing.com/international-dial-in
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate preparing for international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS$(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.
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.
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