Full Press Release Details
For Immediate Release - 7:01 am ET on Wednesday, May 15,
Acurx Pharmaceuticals, Inc. Reports First Quarter
2024 Results and Provides Business Update
Staten Island, NY, May 15, 2024 - Acurx Pharmaceuticals,
Inc. (NASDAQ: ACXP) ("we" or "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 first quarter ended March 31, 2024.
Highlights of the first quarter ended March 31,
2024, or in some cases shortly thereafter, include:
First Quarter of 2024 Financial Results
The Company ended the quarter with cash totaling $8.9 million,
compared to $7.5 million as of December 31, 2023. In the first quarter, the Company sold 1,121,793 shares under its ATM financing program,
with gross proceeds of approximately $4.4 million.
Research and development expenses for the three months ended
March 31, 2024 were $1.6 million compared to $1.0 million for the three months ended March 31, 2023. The increase was due primarily to
an increase in manufacturing related costs.
General and administrative expenses for the three months ended
March 31, 2024 were $2.8 million compared to $1.9 million for the three months ended March 31, 2023. The increase was due primarily to
a $0.7 million increase in professional fees and a $0.2 million increase in non-cash share-based compensation.
The Company reported a net loss of $4.4 million or $0.28 per
diluted share for the three months ended March 31, 2024 compared to a net loss of $2.9 million or $0.25 per diluted share for the three
months ended March 31, 2023 for the reasons previously mentioned.
The Company had 15,757,102 shares outstanding as of March
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, May 15, 2024 |
| Time: | 8:00 a.m. ET |
| Toll free (U.S. and International): | 877-790-1503 |
| Conference ID: | 13746308 |
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+ 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) and drug-resistant Streptococcus pneumoniae (DRSP).
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, 2023, 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 Officer
Email: davidluci@acurxpharma.com
Source: Acurx Pharmaceuticals, Inc.
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (unaudited) | (Note 2) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 8,920,926 | $ | 7,474,188 | ||||
| Other Receivable | - | 129,159 | ||||||
| Prepaid Expenses | 187,908 | 105,776 | ||||||
| TOTAL ASSETS | $ | 9,108,834 | $ | 7,709,123 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts Payable and Accrued Expenses | $ | 3,110,242 | $ | 3,042,438 | ||||
| TOTAL CURRENT LIABILITIES | 3,110,242 | 3,042,438 | ||||||
| TOTAL LIABILITIES | 3,110,242 | 3,042,438 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Common Stock; $.001 par value, 200,000,000 shares authorized, 15,757,102 and 14,468,229 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | 15,757 | 14,468 | ||||||
| Additional Paid-In Capital | 63,579,577 | 57,871,070 | ||||||
| Accumulated Deficit | (57,596,742 | ) | (53,218,853 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 5,998,592 | 4,666,685 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 9,108,834 | $ | 7,709,123 |
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2024 | 2023 | |||||||
| (unaudited) | (unaudited) | |||||||
| OPERATING EXPENSES | ||||||||
| Research and Development | $ | 1,555,011 | $ | 1,015,583 | ||||
| General and Administrative | 2,822,878 | 1,887,374 | ||||||
| TOTAL OPERATING EXPENSES | 4,377,889 | 2,902,957 | ||||||
| NET LOSS | $ | (4,377,889 | ) | $ | (2,902,957 | ) | ||
| LOSS PER SHARE | ||||||||
| Basic and diluted net loss per common share | $ | (0.28 | ) | $ | (0.25 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 15,472,507 | 11,639,395 |