Full Press Release Details
For Immediate Release - 7:01 am ET on Wednesday, November
Acurx Pharmaceuticals, Inc. Reports Third Quarter
2024 Results and Provides Business Update
Staten Island, NY, November 13, 2024 - 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
The Company ended the quarter with cash totaling $5.8 million,
compared to $7.5 million as of December 31, 2023. During the third quarter, the Company raised additional proceeds under its ATM financing
program, with gross proceeds of approximately $1.6 million.
Research and development expenses for the three months ended
September 30, 2024 were $1.2 million compared to $1.3 million for the three months ended September 30, 2023. The decrease was due primarily
to an increase in manufacturing related costs during the quarter of $0.1 million, offset by a reduction in consulting fees of $0.2 million.
For the nine months ended September 30, 2024 research & development expenses were $4.6 million compared to $4.1 million for the nine
months ended September 30, 2023, an increase of $0.5 million primarily due to $0.9 million increase in manufacturing related costs, offset
by $0.4 million decrease in consulting fees.
General and administrative expenses for the three months
ended September 30, 2024 were $1.6 million compared to $1.8 million for the three months ended September 30, 2023, a decrease of $0.2
million. The decrease was primarily due to $0.2 million increase in professional fees, a $0.1 million increase in compensation costs,
offset by a $0.5 million decrease in non cash share-based compensation related costs. For the nine months ended September 30, 2024, general
and administrative expenses were $6.7 million compared to $5.4 million for the nine months ended September 30, 2023, an increase of $1.3
million. The increase was primarily due to $1.1 million increase in professional fees and a $0.2 million increase in legal costs.
The Company reported a net loss of $2.8 million or $0.17
per diluted share for the three months ended September 30, 2024 compared to a net loss of $3.1 million or $0.24 per diluted share for
the three months ended September 30, 2023, and a net loss of $11.3 million or $0.71 per share for the nine months ended September 30,
2024, compared to a net loss of $9.5 million or $0.77 per share for the nine months ended September 30, 2023 for the reasons previously
The Company had 16,770,378 shares outstanding as of September
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 |
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.
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
| 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 |