STATEN ISLAND, N.Y., Aug. 14, 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 second quarter ended June 30, 2026.
Highlights of the second quarter ended June 30, 2026, or in some cases shortly thereafter, include:
-- In April 2026, the Company announced the closing of a registered direct
offering of 825,085 shares of its common stock (or pre-funded warrants in
lieu thereof) at a purchase price of $3.03 per share (or pre-funded
warrant in lieu thereof) priced at-the-market under Nasdaq rules. In
addition, in a concurrent private placement, the Company issued
unregistered short-term warrants to purchase up to 1,650,170 shares of
common stock. The short-term warrants have an exercise price of $2.78 per
share, and are immediately exercisable upon issuance and will expire
twenty-four months following the effective date of the registration
statement registering the resale of the shares of common stock underlying
the short-term warrants. This additional funding when coupled with the
remaining availability under our Equity Line of Credit ensures that the
Company has the financial resource to conduct the exploratory clinical
trial in recurrent C. difficile infection.
-- In April 2026, a scientific poster was presented at the 35th Congress of
ESCMID Global (European Society of Clinical Microbiology and Infectious
Diseases) held in Munich, Germany from April 17-21, 2026 showing that
Acurx's orally absorbed DNA pol IIIC inhibitors in preclinical
development have the unexpected benefit of gut microbiome preservation
while demonstrating systemic antibacterial activity. Dr. Khurshida Begum,
Research Scientist, University of Houston College of Pharmacy presented
the poster demonstrating potentially therapeutic plasma levels, reduction
of MRSA tissue burden and maintaining a substantially higher gut
microbial diversity and community structure similar to baseline and
distinct from linezolid.
-- In July 2026, the Company's research and development team met with the
FDA for the purpose of seeking their guidance on our plan to conduct a
single phase 3 study and its acceptability as a pivotal trial for filing
a New Drug Application (or NDA), the favorable outcome of which we
provided in detail in our press release dated August 3, 2026.
-- In July 2026, presentation of scientific data was provided at the 18th
Biennial Congress of the Anaerobe Society of the Americas held at
Columbia University Irving Medical Center in New York City by Dr. Kevin
Garey and his team from the University of Houston. Data showed that
following treatment with ibezapolstat (IBZ), the beneficial
microorganisms in the gut will have the opportunity to repopulate the
microbiome in a beneficial way that prevents recurrence. In addition, IBZ
and fidaxomicin were superior in biofilm experimental models with IBZ
significantly more effective at killing C. difficile than vancomycin and
fidaxomicin.
-- In July 2026, we signed a continuation of our scientific partnership with
Leiden University Medical Center to advance development of Acurx's DNA
polymerase IIIC (pol IIIC) Inhibitors. This new partnership builds on the
previously reported successful results from the innovative research grant
received in November 2025 from Health-Holland to Leiden University and
Acurx. This new partnership will enable extending mechanistic research
into DNA pol IIIC inhibition to accelerate the development of novel new
agents that are systemically active against a range of Gram-positive
pathogens resistant to currently available antibiotics. This new research
also aims to generate the first-ever 3D structure of Pol C from
methicillin-resistant Staphylococcus aureus (MRSA) in complex with an
Acurx inhibitor to advance discovery of new compounds to treat this
high-priority clinical pathogen.
-- In August 2026, the Company received FDA Conditional Acceptance and USPTO
Trademark Allowance of its proprietary name for ibezapolstat for the
treatment and reduction of recurrence of C. difficile infection.
-- In August 2026, we announced that the Japan and Mexico Patent Offices
granted new patents, respectively, which cover DNA pol IIIC inhibitors
including compositions of matter, methods of use, and pharmaceutical
compositions, which further strengthen Acurx's intellectual property
portfolio and represents the most recent addition to our expanding series
of granted patents in the U.S. and internationally. To date, Acurx has
secured six U.S. patents and an additional ten patents internationally,
including Australia, Canada, Europe, Israel, India, Japan, Korea, and
Mexico, all of which protect key aspects of the Company's ibezapolstat
and the ACX--375C program targeting DNA Polymerase IIIC. Additional
country--level patent applications remain under review.
Second Quarter 2026 Financial Results
Cash Position:
The Company ended the quarter with cash totaling $10.7 million, compared to $7.6 million as of December 31, 2025. During the quarter, the Company raised a total of approximately $2.5 million of gross proceeds through a Registered Direct Offering, as well as $0.8 million under the Equity Line of Credit.
R&D Expenses:
Research and development expenses for the three months ended June 30, 2026 were $1.1 million compared to $0.5 million for the three months ended June 30, 2025, an increase of $0.6 million. The increase was due primarily to an increase in manufacturing costs of $0.3 million, and an increase in consulting costs of $0.3 million as a result of costs associated with the new recurrent CDI trial program. For the six months ended June 30, 2026, research & development expenses were $1.4 million compared to $1.1 million for the six months ended June 30, 2025. The $0.3 million increase was due primarily to a $0.1 million increase in consulting fees and a $0.2 million increase in manufacturing costs as a result of costs associated with the new recurrent CDI trial program.
G&A Expenses:
General and administrative expenses for the three months ended June 30, 2026 were $1.2 million compared to $1.7 million for the three months ended June 30, 2025, a decrease of $0.5 million. The decrease was primarily due to a $0.3 million decrease in professional fees, a $0.1 million decrease in legal costs, and a $0.1 million decrease in share-based compensation expense. For the six months ended June 30, 2026, general and administrative expenses were $2.6 million compared to $3.3 million for the six months ended June 30, 2025, a decrease of $0.7 million. The decrease was due primarily to a $0.3 million decrease in professional fees, $0.2 million decrease in legal costs, and $0.2 million decrease in share-based compensation expense.
Net Income/Loss:
The Company reported a net loss of $2.3 million or $0.53 per diluted share for the three months ended June 30, 2026 compared to a net loss of $2.2 million or $1.89 per diluted share for the three months ended June 30, 2025. For the six months ended June 30, 2026, the Company reported a net loss of $3.9 million or $1.13 per diluted share, compared to $4.4 million or $4.01 per diluted share for the six months ended June 30, 2025, all for the reasons previously mentioned.
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, August 14, 2026
Time: 8:00 a.m. ET
Toll free (U.S.): 1-877-790-1503; Access ID: 13761686
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 advancement into international Phase 3 clinical trials to treat patients with acute C. difficile Infection (CDI) and it is also preparing for a ground-breaking clinical trial targeting the prevention of recurrent CDI (rCDI). If successful, ibezapolstat will change the treatment paradigm for CDI and rCDI by providing one therapy for the full spectrum of CDI and rCDI from first occurrence to multiply recurrent episodes.
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. As previously announced, the Company has received final EMA and FDA agreement for our ibezapolstat pivotal Phase 3 trials in CDI. Their advice included and confirmed the non-inferiority study design elements, the patient population, primary and secondary endpoints, and size of the registration safety database. Acurx also now has a clear international roadmap for conduct of its Phase 3 program in CDI and, if successful, requirements for US NDA submission and EU Marketing Authorization.
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(R)) 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.
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: davidluci@acurxpharma.com
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM BALANCE SHEETS
June 30, December 31,
2026 2025
------------- -------------
(unaudited) (Note 2)
ASSETS
---------------------------------------
CURRENT ASSETS
Cash $ 10,656,386 $ 7,556,100
Other Receivable 95,307 48,417
Prepaid Expenses 233,084 85,018
------------ ------------
TOTAL ASSETS $ 10,984,777 $ 7,689,535
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
---------------------------------------
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses $ 2,832,746 $ 2,420,943
------------ ------------
TOTAL CURRENT LIABILITIES 2,832,746 2,420,943
------------ ------------
TOTAL LIABILITIES 2,832,746 2,420,943
------------ ------------
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY
Preferred Stock; $0.001 par value,
10,000,000 shares authorized, no shares
issued and outstanding at June 30, 2026
and December 31, 2025 -- --
Common Stock; $0.001 par value,
250,000,000 shares authorized,
4,683,253 and 2,348,113 shares issued
and outstanding at June 30, 2026 and
December 31, 2025, respectively 4,683 2,348
Additional Paid-In Capital 87,370,997 80,554,738
Accumulated Deficit (79,223,649) (75,288,494)
------------ ------------
TOTAL SHAREHOLDERS' EQUITY 8,152,031 5,268,592
------------ ------------
TOTAL LIABILITIES AND SHAREHOLDERS'
EQUITY $ 10,984,777 $ 7,689,535
============ ============
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
Three Months Ended Six Months Ended
June 30, June 30,
-------------------------- --------------------------
2026 2025 2026 2025
------------ ------------ ------------ ------------
(unaudited) (unaudited) (unaudited) (unaudited)
OPERATING
EXPENSES
Research and
Development $ 1,071,536 $ 524,210 $ 1,413,004 $ 1,123,009
General and
Administrative 1,235,692 1,745,473 2,610,215 3,323,156
----------- ----------- ----------- -----------
.
TOTAL OPERATING
EXPENSES 2,307,228 2,269,683 4,023,219 4,446,165
----------- ----------- ----------- -----------
OPERATING LOSS (2,307,228) (2,269,683) (4,023,219) (4,446,165)
OTHER INCOME
Interest Income 53,055 23,404 88,064 50,693
----------- ----------- ----------- -----------
NET LOSS $(2,254,173) $(2,246,279) $(3,935,155) $(4,395,472)
=========== =========== =========== ===========
LOSS PER SHARE
Basic and
diluted net
loss per common
share $ (0.53) $ (1.89) $ (1.13) $ (4.01)
=========== =========== =========== ===========
Weighted average
common shares
outstanding,
basic and
diluted 4,259,540 1,190,266 3,493,244 1,096,620
=========== =========== =========== ===========
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SOURCE Acurx Pharmaceuticals, Inc.
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