Full Press Release Details
For Immediate Release - 7:01 am ET on Friday, August 9, 2024
Acurx Pharmaceuticals, Inc. Reports Second Quarter 2024
Results and Provides Business Update
Staten Island, NY, August 9, 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 second quarter ended June 30, 2024.
Highlights of the second quarter ended June 30, 2024, or in some cases
shortly thereafter, include:
| o | In September 2024, the World Antimicrobial Resistance conference in Philadelphia; | |
| o | In September 2024, the 8th International C. difficile Symposium (or ICDS meeting) in Bled, Slovania, which is the premiere global venue for the review of C. difficile research; and | |
| o | In October 2024, we will be presenting at the annual meeting of the Infectious Diseases Society of America (or ID Week) in Los Angeles. |
Second Quarter of 2024 Financial Results
The Company ended the quarter with cash totaling $6.4 million,
compared to $7.5 million as of December 31, 2023. During the second quarter, the Company sold an additional 133,066 shares under its ATM
financing program, with gross proceeds of approximately $0.3 million.
Research and development expenses for the three months ended
June 30, 2024 were $1.8 million compared to $1.7 million for the three months ended June 30, 2023. The increase was due primarily to an
increase in manufacturing related costs during the quarter of $0.4 million, partially offset by a reduction in consulting fees of $0.3
million. For the six months ended June 30, 2024 research & development expenses were $3.4 million compared to $2.8 million for the
six months ended June 30, 2023, an increase of $0.6 million primarily due to $0.8 million increase in manufacturing related costs offset
by $0.2 million decrease in consulting fees.
General and administrative expenses for the three months
ended June 30, 2024 were $2.3 million compared to $1.7 million for the three months ended June 30, 2023, an increase of $0.6
million. The increase was primarily due to $0.3 million increase in professional fees and $0.2 million increase in non cash
share-based compensation related costs. For the six months ended June 30, 2024, general and administrative expenses were $5.1
million compared to $3.6 million for the six months ended June 30, 2023, an increase of $1.5 million. The increase was primarily due
to $1.0 million increase in professional fees, $0.4 million increase in non cash share-based compensation costs and $0.1 million
increase in legal costs
The Company reported a net loss of $4.1 million or $0.26
per diluted share for the three months ended June 30, 2024 compared to a net loss of $3.4 million or $0.28 per diluted share for the three
months ended June 30, 2023, and a net loss of $8.5 million or $0.54 per share for the six months ended June 30, 2024, compared to a net
loss of $6.3 million or $0.53 per share for the reasons previously mentioned.
The Company had 15,996,168 shares outstanding as of June 30,
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
| Date: | Friday, August 9, 2024 |
| Time: | 8:00 a.m. ET |
| Toll free (U.S. and International): | 877-790-1503 |
| Conference ID: | 13747936 |
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.
ITEM 1. CONDENSED INTERIM FINANCIAL STATEMENTS.
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM BALANCE SHEETS
| June 30, | December 31, | |||||||
| 2024 | 2023 | |||||||
| (unaudited) | (Note 2) | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | 6,360,858 | $ | 7,474,188 | ||||
| Other Receivable | 51,127 | 129,159 | ||||||
| Prepaid Expenses | 168,407 | 105,776 | ||||||
| TOTAL ASSETS | $ | 6,580,392 | $ | 7,709,123 | ||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts Payable and Accrued Expenses | $ | 3,152,917 | $ | 3,042,438 | ||||
| TOTAL CURRENT LIABILITIES | 3,152,917 | 3,042,438 | ||||||
| TOTAL LIABILITIES | 3,152,917 | 3,042,438 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| SHAREHOLDERS' EQUITY | ||||||||
| Common Stock; $.001 par value, 200,000,000 shares authorized, | ||||||||
| 15,996,168 and 14,468,229 shares issued and outstanding at | ||||||||
| June 30, 2024 and December 31, 2023, respectively | 15,996 | 14,468 | ||||||
| Additional Paid-In Capital | 65,130,047 | 57,871,070 | ||||||
| Accumulated Deficit | (61,718,568 | ) | (53,218,853 | ) | ||||
| TOTAL SHAREHOLDERS' EQUITY | 3,427,475 | 4,666,685 | ||||||
| TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 6,580,392 | $ | 7,709,123 |
PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||||||||
| OPERATING EXPENSES | ||||||||||||||||
| Research and Development | $ | 1,825,582 | $ | 1,736,386 | $ | 3,380,593 | $ | 2,751,969 | ||||||||
| General and Administrative | 2,296,244 | 1,708,854 | 5,119,122 | 3,596,228 | ||||||||||||
| TOTAL OPERATING EXPENSES | 4,121,826 | 3,445,240 | 8,499,715 | 6,348,197 | ||||||||||||
| NET LOSS | $ | (4,121,826 | ) | $ | (3,445,240 | ) | $ | (8,499,715 | ) | $ | (6,348,197 | ) | ||||
| LOSS PER SHARE | ||||||||||||||||
| Basic and diluted net loss per common share | $ | (0.26 | ) | $ | (0.28 | ) | $ | (0.54 | ) | $ | (0.53 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 15,824,654 | 12,186,481 | 15,677,426 | 11,914,449 |