Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2023 Results and Provides Business Update
STATEN ISLAND, N.Y., March 18, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("we" or "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 fourth quarter and full year ended December 31, 2023.
Highlights of the fourth quarter ended December 31, 2023, or in some cases shortly thereafter, include:
-- In October 2023, we ended enrollment in our Phase 2b clinical trial of
ibezapolstat, our lead antibiotic candidate, for the treatment of
patients with C. difficile infection, or CDI.
-- In November 2023, we reported top-line data from the Phase 2b clinical
trial, including overall results from the full Phase 2 study,
demonstrating an ibezapolstat clinical cure rate at end of 10-days' oral
treatment, or EOT, of 96% (25 of 26 patients) which included 100% cure
in Phase 2a (10 of 10 patients) and 94% in Phase 2b (15 of 16 patients)
compared with the vancomycin control arm of 100% (14 of 14 patients) at
EOT. No safety concerns were reported in either arm of the Phase 2b
clinical trial and ibezapolstat was well tolerated in all patients in
both the Phase 2a open label trial and in the Phase 2b
vancomycin-controlled segment. In consultation with its scientific
advisors, the Company determined that based on review of aggregate
blinded data the Phase 2b vancomycin-controlled trial segment was
terminated early due to success showing high observed clinical cure
rates with no emerging safety concerns. We also stated at that further
data would be provided as they become available on secondary and
exploratory endpoints from the Phase 2b trial segment, including
sustained clinical cure data at 30 days after EOT, and Extended Clinical
cure data up to 94 days as well as comparative data on the impact to the
patient's microbiome.
-- In December 2023, we announced the sustained clinical cure data. These
data showed that in the Phase 2b clinical trial segment 100% or 15 out
of 15 patients who were cured at EOT remained cured with no reinfection
30 days later while vancomycin experienced a reinfection rate of 14.3%
(2 of 14 patients).
-- In January 2024, the Company announced positive comparative microbiology
and microbiome data for ibezapolstat in CDI patients from the Phase 2b
clinical trial segment. Ibezapolstat outperformed vancomycin showing
eradication of fecal C. difficile at Day 3 of treatment in 15 of 16
treated patients (94%), versus vancomycin which had eradication of C.
difficile in 10 of 14 treated patients (71%). Additional data from this
Phase 2b clinical trial showed ibezapolstat, but not vancomycin,
consistently preserved and allowed regrowth of key gut bacterial species
believed to confer health benefits including to prevent recurrence of
CDI.
-- The Company anticipates that additional data from the secondary and
exploratory endpoints will provide further favorable separation between
these two therapeutic options in our Phase 3 clinical trial program and
ultimately in the marketplace, if approved. Additional analyses
regarding other secondary and exploratory endpoints will be forthcoming
as data become available.
-- Having robust preclinical, clinical and manufacturing data-to-date, the
Company submitted a formidable Information Package to FDA in February
2024 along with a Request for an End of Phase 2 Meeting which was
granted by the FDA and is scheduled to occur in April. We anticipate
discussing our Phase 3 clinical trial mandate at this meeting and would
anticipate documented meeting minutes from FDA in the second quarter of
2024.
-- The European Medicines Agency (or EMA) approved our application to be
designated as a small to medium sized enterprise (or SME) in Europe in
February 2024 which provides for certain benefits including fee
reductions and other support from the EMA for seeking a Marketing
Authorization for Europe.
-- In October 2023, Dr. Kevin Garey presented on behalf of the Company at
ID Week with selective spectrum of activity data from our Phase 2a
clinical trial. Dr. Garey is Professor and Chair, University of Houston
College of Pharmacy, and the Principal Investigator for microbiome
aspects of our ibezapolstat clinical trial program. Also at ID Week, Bob
DeLuccia, our Executive Chairman, presented our new class of novel DNA
pol IIIC inhibitors in our pre-clinical pipeline at the symposium
entitled, "New Antimicrobials in the Pipeline."
-- In November 2023, the Company filed an amendment to its shelf
registration statement with the SEC and launched a $17 million
at-the-market equity offering program (or ATM), with Alliance Global
Partners acting as sales agent to the Company. Proceeds from the ATM
have been and, in the future, are expect to be used for general
corporate purposes going forward including our planned Phase 3 clinical
trial mandate.
Fourth Quarter and Full Year 2023 Financial Results
-- Cash Position:The Company ended the year with cash totaling $7.5
million, compared to $9.1 million as of December 31, 2022. Subsequent to
year-end, the Company sold an additional 1,121,793 shares under its ATM
financing program, with gross proceeds of approximately $4.5 million.
-- R&D Expenses:Research and development expenses for the three months
ended December 31, 2023 were $1.9 million compared to $1.4 million for
the three months ended December 31, 2022. The increase was due to the
timing of Phase 2b trial related costs and an increase in consulting
costs. For the year ended December 31, 2023, research and development
expenses were $6.0 million versus $4.8 million for the year ended
December 31, 2022. The increase is due primarily to Phase 2b
trial-related costs and an increase in consulting costs.
-- G&A Expenses:General and administrative expenses for the three months
ended December 31, 2023 were $3.2 million compared to $1.8 million for
the three months ended December 31, 2022. The increase was due primarily
to a $0.8 million increase in professional fees, a $0.1 million increase
in share-based compensation, and a $0.3 million increase in employee
compensation costs. For the year ended December 31, 2023, general and
administrative expenses were $8.5 million versus $7.3 million for the
year ended December 31, 2022. The amounts reflect an increase in
professional fees of $0.5 million, an increase of $0.3 million in
share-based compensation, and an increase of $0.3 million in employee
compensation costs.
-- Net Income/Loss:The Company reported a net loss of $5.1 million or $0.37
per diluted share for the three months ended December 31, 2023 compared
to a net loss of $3.3 million or $0.28 per diluted share for the three
months ended December 31, 2022, and a net loss of $14.6 million or $1.15
per share for the year ended December 31, 2023, compared to a net loss
of $12.1 million or $1.12 per diluted share for the year ended December
31, 2022 for the reasons previously mentioned.
The Company had 14,468,229 shares outstanding as of December 31, 2023.
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, March 18,
2024
Time: 8:00 a.m. ET
Toll free (U.S. and International): 877-790-1503
Conference ID: 13744881
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate advancing 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.
BALANCE SHEETS
AS OF DECEMBER 31, 2023 and 2022
December 31, December 31,
2023 2022
ASSETS
---
CURRENT ASSETS
Cash $
7,474,188 $
9,111,751
Other Receivable 129,159
Prepaid Expenses 105,776 264,955
TOTAL ASSETS $
7,709,123 $
9,376,706
LIABILITIES AND SHAREHOLDERS' EQUITY
---
CURRENT LIABILITIES
Accounts Payable and Accrued Expenses $
3,042,438 $
2,061,685
TOTAL CURRENT LIABILITIES 3,042,438 2,061,685
TOTAL LIABILITIES 3,042,438 2,061,685
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY
Common Stock; $.001 par value, 200,000,000 shares authorized, 14,468 11,628
14,468,229 and 11,627,609 shares issued and outstanding at
December 31, 2023 and December 31, 2022, respectively
Additional Paid-In Capital 57,871,070 45,944,478
Accumulated Deficit (53,218,853) (38,641,085)
TOTAL SHAREHOLDERS' EQUITY 4,666,685 7,315,021
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $
7,709,123 $
9,376,706
ACURX PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS
YEARS ENDED DECEMBER 31, 2023 AND 2022
Years Ended
December 31,
2023 2022
OPERATING EXPENSES
Research and Development $
6,043,597 $
4,754,271
General and Administrative 8,534,171 7,338,505
TOTAL OPERATING EXPENSES 14,577,768 12,092,776
NET LOSS $
(14,577,768) $
(12,092,776)
LOSS PER SHARE
Basic and diluted net loss per common share $
(1.15) $
(1.12)
Weighted average common shares outstanding, basic and diluted 12,671,572 10,816,412
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SOURCE Acurx Pharmaceuticals, Inc.
