Full Press Release Details
For Immediate Release - 7:01 am ET on
Tuesday, March 18, 2025
Acurx Pharmaceuticals,
Inc. Reports Fourth Quarter and Full Year 2024 Results and Provides Business Update
Staten Island, NY, March 18, 2025 -
Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company
developing a new class of antibiotics for difficult-to-treat bacterial infections, announced today certain financial and operational results
for the fourth quarter and full year ended December 31, 2024.
Highlights of the fourth quarter ended December
31, 2024, or in some cases shortly thereafter, include:
According to Dr. Garey: "These exciting
results demonstrate two properties of ibezapolstat which may contribute to its anti-recurrence effect. First, the preservation and restoration
of beneficial bacterial classes in the gut provide resistance to recolonization by C. difficile. Second, these data, presented for the
first time, indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ibezapolstat-treated
patients providing another important mechanism to prevent recurrent CDI"
This study is the first ever head-to-head
comparison of gut microbiome changes associated with IBZ when compared to other anti-CDI antibiotics in a germ-free mouse model.
The data showed that changes in alpha and
beta microbiome diversities following IBZ treatment were less pronounced compared to those observed in vancomycin (VAN)-or metronidazole
(MET)-treated groups, complementing prior Phase 2 clinical findings showing IBZ's more selective antibacterial activity.
Further, and very importantly, notable
differences were observed between the microbiome of IBZ- and the fidaxomicin (FDX)-treated groups, which may allow for differentiation
of these two anti-CDI antibiotics in future studies.
These results establish IBZ's differentiating
effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to broader-spectrum antibiotics
like VAN and MET and a narrower spectrum of microbiome alteration compared to FDX.
Fourth Quarter and Full Year 2024 Financial
The Company ended the year with cash totaling
$3.7 million, compared to $7.5 million as of December 31, 2023. The Company raised a total of $6.6 million of gross proceeds under its
ATM financing program for the year ended December 31, 2024.
Research and development expenses for the
three months ended December 31, 2024 were $0.8 million compared to $1.9 million for the three months ended December 31, 2023, a decrease
of $1.1 million. The decrease was due primarily to a decrease in consulting related costs of $1.2 million, offset by an increase in manufacturing
costs of $0.1 million. For the year ended December 31, 2024 research & development expenses were $5.4 million compared to $6.0 million
for the year ended December 31, 2023, a decrease of $0.6 million. The decrease was primarily due to a $1.6 million decrease in consulting
related costs, offset by a $1.0 million increase in manufacturing related costs.
General and administrative expenses for
the three months ended December 31, 2024 were $2.0 million compared to $3.2 million for the three months ended December 31, 2023, a decrease
of $1.2 million. The decrease was primarily due to $0.5 million decrease in professional fees, a $0.5 million decrease in share-based
compensation costs, and a $0.2 million decrease in employee compensation costs. For the year ended December 31, 2024, general and administrative
expenses were $8.7 million compared to $8.5 million for the year ended December 31, 2023, an increase of $0.2 million. The increase was
primarily due to $0.7 million increase in professional fees, a $0.3 million increase in legal fees, offset by a $0.6 million decrease
in share-based compensation costs and a $0.2 million decrease in insurance costs.
The Company reported a net loss of $2.8
million or $0.16 per diluted share for the three months ended December 31, 2024 compared to a net loss of $5.1 million or $0.37 per diluted
share for the three months ended December 31, 2023, and a net loss of $14.1 million or $0.87 per share for the year ended December 31,
2024, compared to a net loss of $14.6 million or $1.15 per share for the year ended December 31, 2023 for the reasons previously mentioned.
The Company had 17,030,686 shares outstanding as
of December 31, 2024.
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: | Tuesday, March 18, 2025 | |
| Time: | 8:00 a.m. ET | |
| Toll free (U.S.): | 1-877-790-1503; Conference ID: 13752142 | |
| International: | Click here for participant international Toll-Free access numbers | |
| https://www.incommconferencing.com/international-dial-in |
Ibezapolstat is the Company's lead antibiotic
candidate advancing to 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. 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-positive
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 is Phase 3 ready with plans in progress to begin international clinical trials next year. 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, 2024, 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.
Acurx Pharmaceuticals, Inc.
David P. Luci, President & Chief Executive
Email: davidluci@acurxpharma.com
Source: Acurx Pharmaceuticals, Inc.
ACURX PHARMACEUTICALS, INC.
AS OF DECEMBER 31, 2024 and 2023
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 3,706,713 | $ | 7,474,188 | ||||
| Other Receivable | 51,127 | 129,159 | ||||||
| Prepaid Expenses | 100,123 | 105,776 | ||||||
| TOTAL ASSETS | $ | 3,857,963 | $ | 7,709,123 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts Payable and Accrued Expenses | $ | 3,242,842 | $ | 3,042,438 | ||||
| TOTAL CURRENT LIABILITIES | 3,242,842 | 3,042,438 | ||||||
| TOTAL LIABILITIES | 3,242,842 | 3,042,438 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Common Stock; $.001 par value, 200,000,000 shares authorized, 17,030,686 and 14,468,229 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively | 17,031 | 14,468 | ||||||
| Additional Paid-In Capital | 67,920,046 | 57,871,070 | ||||||
| Accumulated Deficit | (67,321,956 | ) | (53,218,853 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 615,121 | 4,666,685 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 3,857,963 | $ | 7,709,123 |
ACURX PHARMACEUTICALS, INC.