Acurx Pharmaceuticals, Inc. Reports Third Quarter 2022 Results and Provides Business Update
Acurx Pharmaceuticals (NASDAQ: ACXP) reported its financial results for Q3 2022, with a net loss of $3.5 million ($0.32 per diluted share), a decrease from a $4.6 million loss in Q3 2021. Cash reserves declined to $10.6 million from $13.0 million at the end of 2021. Increased R&D expenses reached $1.6 million, attributed to Phase 2b trial costs. General and administrative expenses fell to $2.0 million, down from $3.5 million a year prior. The company is expanding its C. difficile Infection clinical trial to 30 sites and presented favorable data on ibezapolstat at recent conferences.
- Decreased net loss from $4.6 million in Q3 2021 to $3.5 million in Q3 2022.
- Expansion of the Phase 2b clinical trial for C. difficile Infection to up to 30 sites.
- Favorable laboratory data presented at scientific conferences showcasing ibezapolstat's efficacy.
- Cash reserves declined from $13.0 million at the end of 2021 to $10.6 million.
- Research and development expenses increased to $1.6 million due to trial-related costs, indicating higher operational spending.
STATEN ISLAND, N.Y., Nov. 14, 2022 /PRNewswire/ -- 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 September 30, 2022.
Highlights of, and certain events subsequent to, the third quarter of 2022 include:
- Enrollment continues in the Company's ongoing Phase 2b clinical trial of patients with C. difficile Infection (CDI);
- Due to slower than expected enrollment, the Company has added several clinical trial sites and anticipates that a total of up to 30 clinical trial sites will participate in the Phase 2b clinical trial;
- The Company has continued its R&D collaboration with Leiden University Medical Center (Holland) to further evaluate the mechanism-of-action of Acurx's inhibitors against the DNA pol IIIC enzyme, which is the bacterial target of our antibiotic product pipeline for the systemic treatment (IV and oral) of other gram-positive bacterial infections.
- The Company has now completed certain portions of its laboratory study at the University of Houston comparing the killing effect of ibezapolstat to vancomycin, fidaxomicin and metronidazole using both in vitro and ex vivo analyses. Certain results were presented at the Anaerobe Society of America annual scientific conference and results demonstrated that ibezapolstat has favorable killing kinetics compared to vancomycin to treat C. difficile infection at standard and high bacterial concentrations, supporting continued development of this first-in-class antibiotic to treat C. difficile Infection.
Scientific presentations of various aspects of ibezapolstat data were presented on behalf of the Company at two recent, prominent scientific conferences as follows: - The Antimicrobial Resistance Conference (September 7, 2022);
- ID Week (October 20, 2022)
- In July 2022, the Company raised
$4.22 5 million of gross proceeds by consummating a registered direct offering to one U.S. institutional investor and three executives of the Company at$3.25 per share (for the U.S. institutional investor) and$3.80 per share (for the Company's executives who invested$225,000 in total) with a total of 1,159,211 common shares and 130,769 pre-funded warrants issued. Warrants to purchase common stock totaled 2,579,960 with warrant coverage at an exercise price of$3.25 per share for the U.S. institutional investor and$3.55 per share for the Company's executives.
Third Quarter 2022 Financial Results
The Company ended the third quarter on September 30, 2022, with cash totaling
Research and development expenses for the three months ended September 30, 2022 were
General and administrative expenses for the three months ended September 30, 2022 were
The Company reported a net loss of
The Company had 11,592,609 shares outstanding as of September 30, 2022.
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: | Monday, November 14, 2022 |
Time: | 8:30 a.m. ET |
Toll free (U.S.): | 877-790-1503 |
International: | Click here for participant international Toll-Free access numbers |
Conference ID: | 13733824 |
About Ibezapolstat
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
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.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President & CEO
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
ACURX PHARMACEUTICALS, INC. | ||||||
CONDENSED INTERIM BALANCE SHEETS | ||||||
September 30, | December 31, | |||||
2022 | 2021 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 10,607,341 | $ | 12,958,846 | ||
Prepaid Expenses | 337,807 | 295,304 | ||||
TOTAL ASSETS | $ | 10,945,148 | $ | 13,254,150 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 1,182,080 | $ | 843,909 | ||
TOTAL CURRENT LIABILITIES | 1,182,080 | 843,909 | ||||
TOTAL LIABILITIES | 1,182,080 | 843,909 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; $.001 par value, 200,000,000 shares authorized, 11,592,609 and 10,215,792 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively | 11,593 | 10,216 | ||||
Additional Paid-In Capital | 45,132,049 | 38,948,334 | ||||
Accumulated Deficit | (35,380,574) | (26,548,309) | ||||
TOTAL SHAREHOLDERS' EQUITY | 9,763,068 | 12,410,241 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 10,945,148 | $ | 13,254,150 | ||
ACURX PHARMACEUTICALS, INC. | |||||||||||||
CONDENSED INTERIM STATEMENTS OF OPERATIONS | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES | |||||||||||||
Research and Development | $ | 1,591,043 | $ | 1,126,972 | $ | 3,321,623 | $ | 1,313,954 | |||||
General and Administrative | 1,950,551 | 3,515,250 | 5,510,642 | 8,873,160 | |||||||||
TOTAL OPERATING EXPENSES | 3,541,594 | 4,642,222 | 8,832,265 | 10,187,114 | |||||||||
Gain on Forgiveness of Paycheck Protection Program Loan | — | — | — | 66,503 | |||||||||
NET LOSS | $ | (3,541,594) | $ | (4,642,222) | $ | (8,832,265) | $ | (10,120,611) | |||||
LOSS PER SHARE | |||||||||||||
Basic and diluted net loss per common share/units | $ | (0.32) | $ | (0.46) | $ | (0.84) | $ | (1.27) | |||||
Weighted average common shares/units outstanding basic and diluted | 11,148,402 | 10,116,403 | 10,551,503 | 7,988,563 | |||||||||
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SOURCE Acurx Pharmaceuticals, Inc.
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