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7:01 am ET on Wednesday

Key Takeaway: For Immediate Release - 7:01 am ET on Wednesday, May Pharmaceuticals, Inc. Reports First Quarter 2022 Results and Provides Business Update Island, NY, May 11, 2022 - Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical compa

Full Press Release Details

For Immediate Release - 7:01 am ET on Wednesday, May
Pharmaceuticals, Inc. Reports First Quarter 2022 Results and Provides Business Update
Island, NY, May 11, 2022 - 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 quarter ended March 31, 2022.
Highlights of, and certain events subsequent to,
the first quarter of 2022 include:
Quarter 2022 Financial Results
The Company ended the first quarter on March
31, 2022, with cash totaling $11.1 million compared to $13.0 million as of December 31, 2021.
Research and development expenses for the quarter ended March 31, 2022
were $0.8 million compared to $0.1 million for the quarter ended March 31, 2021. The increase was primarily due to Phase 2b trial related
costs and increased consulting costs.
General and administrative expenses for the quarter ended March 31,
2022 were $1.9 million compared to $1.4 million for the quarter ended March 31, 2021. The increase was primarily due to increases in professional
fees, legal and insurance costs.
The Company reported a net loss of $2.7 million or $0.26 per diluted
share for the three months ended March 31, 2022 compared to a net loss of $1.5 million or $0.21 per diluted share for the three months
ended March 31, 2021, for the reasons mentioned above.
The Company had 10,263,202 shares outstanding as of March 31, 2022.
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 11, 2022
Time: 8:30 a.m. ET
Toll free (U.S.): 877-790-1503
International: Click here for participant international Toll-Free access numbers https://www.incommconferencing.com/international-dial-in
Conference ID: 13729712
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.
The Company successfully completed Phase
1 and Phase 2a clinical trials of ibezapolstat. The Phase 2a trial demonstrated 100% clinical cure and 100% sustained clinical cure in
patients with C. difficile Infection (CDI), along with beneficial microbiome changes during treatment including overgrowth of Actinobacteria
and Firmicutes phylum species while on therapy and new findings which demonstrate potentially beneficial effects on bile acid metabolism.
Acurx is currently enrolling patients in its Phase 2b 64-patient, randomized (1-to-1), non-inferiority, double-blind trial of oral
ibezapolstat compared to oral vancomycin, a standard of care to treat CDI.
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 clinical stage biopharmaceutical company
focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that
target the DNA polymerase IIIC enzyme and 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, 2021, 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 & CEO
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM BALANCE SHEETS
March 31, December 31,
2022 2021
(unaudited) (Note 2)
ASSETS
CURRENT ASSETS
Cash $ 11,082,846 $ 12,958,846
Prepaid Expenses 239,454 295,304
TOTAL ASSETS $ 11,322,300 $ 13,254,150
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses $ 633,028 $ 843,909
TOTAL CURRENT LIABILITIES 633,028 843,909
TOTAL LIABILITIES 633,028 843,909
COMMITMENTS AND CONTINGENCIES
Common Stock; $.001 par value, 200,000,000 shares authorized, 10,263,202 and 10,215,792 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively 10,263 10,216
Additional Paid-In Capital 39,897,456 38,948,334
Accumulated Deficit (29,218,447 ) (26,548,309 )
TOTAL SHAREHOLDERS' EQUITY 10,689,272 12,410,241
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 11,322,300 $ 13,254,150
ACURX PHARMACEUTICALS, INC.
CONDENSED INTERIM STATEMENTS OF OPERATIONS
Three Months Ended
March 31,
2022 2021
(unaudited) (unaudited)
OPERATING EXPENSES
Research and Development $ 818,888 $ 91,908
General and Administrative 1,851,250 1,382,421
TOTAL OPERATING EXPENSES 2,670,138 1,474,329
NET LOSS $ (2,670,138 ) $ (1,474,329 )
LOSS PER SHARE
Basic and diluted net loss per common share/units $ (0.26 ) $ (0.21 )
Weighted average common shares/units outstanding basic and diluted 10,232,843 6,867,289
Last updated: May 11, 2022