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
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Time:
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8:00 a.m.
ET
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Toll free (U.S. and
International):
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877-790-1503
|
Conference
ID:
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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
|
|
|
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December 31,
|
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December 31,
|
|
|
2023
|
|
2022
|
|
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ASSETS
|
|
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|
|
|
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|
|
|
|
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CURRENT
ASSETS
|
|
|
|
|
|
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Cash
|
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$
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7,474,188
|
|
$
|
9,111,751
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Other
Receivable
|
|
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129,159
|
|
|
—
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Prepaid
Expenses
|
|
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105,776
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|
|
264,955
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TOTAL
ASSETS
|
|
$
|
7,709,123
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|
$
|
9,376,706
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|
|
|
|
|
|
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LIABILITIES AND SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
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CURRENT
LIABILITIES
|
|
|
|
|
|
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Accounts Payable and
Accrued Expenses
|
|
$
|
3,042,438
|
|
$
|
2,061,685
|
TOTAL CURRENT
LIABILITIES
|
|
|
3,042,438
|
|
|
2,061,685
|
|
|
|
|
|
|
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TOTAL
LIABILITIES
|
|
|
3,042,438
|
|
|
2,061,685
|
|
|
|
|
|
|
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COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
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SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
Common Stock; $.001 par
value, 200,000,000 shares authorized,
14,468,229 and 11,627,609 shares issued and outstanding at
December 31, 2023 and December 31, 2022,
respectively
|
|
|
14,468
|
|
|
11,628
|
Additional Paid-In
Capital
|
|
|
57,871,070
|
|
|
45,944,478
|
Accumulated
Deficit
|
|
|
(53,218,853)
|
|
|
(38,641,085)
|
|
|
|
|
|
|
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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
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|
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Years
Ended
|
|
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December 31,
|
|
|
2023
|
|
2022
|
|
|
|
|
|
|
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OPERATING
EXPENSES
|
|
|
|
|
|
|
Research and
Development
|
|
$
|
6,043,597
|
|
$
|
4,754,271
|
General and
Administrative
|
|
|
8,534,171
|
|
|
7,338,505
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|
|
|
|
|
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TOTAL OPERATING
EXPENSES
|
|
|
14,577,768
|
|
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12,092,776
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|
|
|
|
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NET LOSS
|
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$
|
(14,577,768)
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$
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(12,092,776)
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|
|
|
|
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LOSS PER
SHARE
|
|
|
|
|
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Basic and diluted net
loss per common share
|
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$
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(1.15)
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$
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(1.12)
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
12,671,572
|
|
|
10,816,412
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content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-fourth-quarter-and-full-year-2023-results-and-provides-business-update-302090837.html
SOURCE Acurx Pharmaceuticals, Inc.