STATEN ISLAND, N.Y., Nov. 13, 2024 /PRNewswire/ — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“we” or “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, 2024.
Highlights of the third quarter ended September 30, 2024, or in some cases shortly thereafter, include:
Third Quarter 2024 Financial Results
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 13, 2024
Time:
8:00 a.m. ET
Toll free (U.S. and International):
877-790-1503
Conference ID:
13749688
About Ibezapolstat
Ibezapolstat is the Company’s lead antibiotic candidate preparing to advance 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.
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
September 30,
December 31,
2024
2023
(unaudited)
(Note 2)
ASSETS
CURRENT ASSETS
Cash
$
5,762,564
$
7,474,188
Other Receivable
97,373
129,159
Prepaid Expenses
122,822
105,776
TOTAL ASSETS
$
5,982,759
$
7,709,123
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses
$
3,318,765
$
3,042,438
TOTAL CURRENT LIABILITIES
3,318,765
3,042,438
TOTAL LIABILITIES
3,318,765
3,042,438
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS’ EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized,
16,770,378 and 14,468,229 shares issued and outstanding at
September 30, 2024 and December 31, 2023, respectively
16,770
14,468
Additional Paid-In Capital
67,187,389
57,871,070
Accumulated Deficit
(64,540,165)
(53,218,853)
TOTAL SHAREHOLDERS’ EQUITY
2,663,994
4,666,685
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$
5,982,759
$
7,709,123
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
Three Months Ended
Nine Months Ended
September 30,
September 30,
2024
2023
2024
2023
(unaudited)
(unaudited)
(unaudited)
(unaudited)
OPERATING EXPENSES
Research and Development
$
1,198,184
$
1,348,985
$
4,578,777
$
4,100,954
General and Administrative
1,623,413
1,765,996
6,742,535
5,362,224
TOTAL OPERATING EXPENSES
2,821,597
3,114,981
11,321,312
9,463,178
NET LOSS
$
(2,821,597)
$
(3,114,981)
$
(11,321,312)
$
(9,463,178)
LOSS PER SHARE
Basic and diluted net loss per common
share
$
(0.17)
$
(0.24)
$
(0.71)
$
(0.77)
Weighted average common shares
outstanding, basic and diluted
16,363,473
13,005,128
15,907,778
12,282,004
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SOURCE Acurx Pharmaceuticals, Inc.
