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:
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- The Antimicrobial Resistance Conference (September 7, 2022);
- ID Week (October 20, 2022)
- In July 2022, the Company raised
$4.225 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
$10.6 million compared to
$13.0 million as of December 31, 2021.
Research and development expenses for the three months ended
September 30, 2022 were $1.6 million compared to $1.1 million for the three months ended
September 30, 2021. The
increase was due to an increase in Phase 2b trial related costs and an increase in
consulting costs primarily related thereto. For the
nine months ended September 30, 2022,
research and development expenses were $3.3
million versus $1.3 million
for the nine months ended September
30, 2021. This increase was due primarily to Phase
2b trial related costs in the current
nine-month period and an increase in consulting costs related
thereto.
General and administrative expenses for the three months ended
September 30, 2022 were $2.0 million compared to $3.5 million for the three months ended
September 30, 2021. The
decrease was primarily due to a decrease in share-based
compensation related to the Company's initial public offering and a
decrease in legal fees associated with the Company's intellectual
property estate. For the nine months ended September 30, 2022, general and administrative
expenses were $5.5 million versus
$8.9 million for the nine months
ended September 30, 2021. The
decrease was primarily attributable to a decrease in professional
fees and stock-based compensation related to the Company's initial
public offering, partially offset by an increase in insurance
costs.
The Company reported a net loss of $3.5
million or $0.32 per diluted
share for the three months ended September
30, 2022 compared to a net loss of $4.6 million or $0.46 per diluted share for the three months
ended September 30, 2021, and a net
loss of $8.8 million or $0.84 per share for the nine months ended
September 30, 2022, compared to a net
loss of $10.1 million or $1.27 per diluted share for the nine months ended
September 30, 2021 for the reasons
previously mentioned.
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:
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Monday, November 14,
2022
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Time:
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8:30 a.m. ET
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Toll free
(U.S.):
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877-790-1503
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International:
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Click here for
participant international Toll-Free access numbers
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https://www.incommconferencing.com/international-dial-in
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Conference
ID:
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13733824
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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 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.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President &
CEO
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
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ACURX
PHARMACEUTICALS, INC.
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CONDENSED INTERIM
BALANCE SHEETS
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September 30,
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December 31,
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2022
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2021
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(unaudited)
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(Note
2)
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ASSETS
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CURRENT
ASSETS
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Cash
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$
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10,607,341
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$
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12,958,846
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Prepaid
Expenses
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337,807
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295,304
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TOTAL
ASSETS
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$
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10,945,148
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$
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13,254,150
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LIABILITIES AND
SHAREHOLDERS' EQUITY
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CURRENT
LIABILITIES
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Accounts Payable and
Accrued Expenses
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$
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1,182,080
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$
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843,909
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TOTAL CURRENT
LIABILITIES
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1,182,080
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843,909
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TOTAL
LIABILITIES
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1,182,080
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843,909
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COMMITMENTS AND
CONTINGENCIES
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SHAREHOLDERS'
EQUITY
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Common Stock; $.001 par
value, 200,000,000 shares authorized, 11,592,609 and 10,215,792
shares issued and outstanding at September 30, 2022 and
December 31, 2021, respectively
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11,593
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10,216
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Additional Paid-In
Capital
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45,132,049
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38,948,334
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Accumulated
Deficit
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(35,380,574)
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(26,548,309)
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TOTAL SHAREHOLDERS'
EQUITY
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9,763,068
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12,410,241
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TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
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$
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10,945,148
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$
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13,254,150
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ACURX
PHARMACEUTICALS, INC.
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CONDENSED INTERIM
STATEMENTS OF OPERATIONS
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Three Months
Ended
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Nine Months
Ended
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September 30,
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September 30,
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2022
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2021
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2022
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2021
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(unaudited)
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(unaudited)
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(unaudited)
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(unaudited)
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OPERATING
EXPENSES
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Research and
Development
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$
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1,591,043
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$
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1,126,972
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$
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3,321,623
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$
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1,313,954
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General and
Administrative
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1,950,551
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3,515,250
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5,510,642
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8,873,160
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TOTAL OPERATING
EXPENSES
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3,541,594
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4,642,222
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8,832,265
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10,187,114
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Gain on Forgiveness of
Paycheck Protection Program Loan
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|
|
—
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—
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—
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66,503
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NET LOSS
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$
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(3,541,594)
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$
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(4,642,222)
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$
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(8,832,265)
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$
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(10,120,611)
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LOSS PER
SHARE
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Basic and diluted net
loss per common share/units
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$
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(0.32)
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$
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(0.46)
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$
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(0.84)
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$
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(1.27)
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Weighted average common
shares/units outstanding basic and diluted
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|
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11,148,402
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10,116,403
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10,551,503
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7,988,563
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View original
content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-third-quarter-2022-results-and-provides-business-update-301675394.html
SOURCE Acurx Pharmaceuticals, Inc.