STATEN ISLAND, N.Y.,
Nov. 12, 2021 /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, 2021.
Highlights of, and certain events subsequent to, the third
quarter of 2021 include:
- 12 clinical trial sites have been activated to commence
enrollment of the Company's Phase 2b
clinical trial of patients with C difficile infection (CDI)
with enrollment expected to be completed in the second quarter of
2022;
- Additional microbiome data from the Phase 2a trial of
ibezapolstat in patients with CDI were presented at two prominent
scientific conferences shortly after completion of the third
quarter;
- This Ph2a trial demonstrated 100% clinical cure and 100%
sustained clinical cure with ibezapolstat 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
- These reported clinical results support the expectation that
microbiome effects may be predictive of beneficial patient outcomes
including low rates of recurrence
- The previously announced R&D program in collaboration with
Leiden University Medical Center in Holland was launched 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.
Third Quarter 2021 Financial Results
Research and development expenses for the three months ended
September 30, 2021 were $1.1 million compared to $0.7 million for the three months ended
September 30, 2020. The increase is
primarily due to Phase 2B trial
related costs. For the nine-months ended September 30, 2021, research and development
expenses were $1.3 million compared
to $1.7 million for the nine-months
ended September 30, 2020. The
decrease is due to the Phase 2a trial related costs which was
completed in 2020.
Selling, general and administrative expenses for the three
months ended September 30, 2021 were
$3.5 million compared to $0.7 million for the three months ended
September 30, 2020. The
increase was primarily due to non-cash stock-based compensation and
increases in professional fees, insurance and legal costs.
For the nine-months ended September 30,
2021, selling, general and administrative expenses were
$8.9 million compared to $1.8 million for the nine-months ended
September 30, 2020. The
increase in general and administrative expenses is primarily
attributable to increases in non-cash stock-based compensation,
professional fees, stock-based director fees, and insurance and
legal costs.
The Company reported a net loss of $4.6
million or $(0.46) per diluted
share for the three months ended September
30, 2021 compared to a net loss of $1.3 million or $(0.21) per diluted share for the three months
ended September 30, 2020 and a net
loss of $10.1 million or $(1.27) per diluted share for the nine-months
ended September 30, 2021, compared to
a net loss of $3.5 million or
$(0.58) per diluted share for the
nine-months ended September 30, 2020,
for the reasons previously mentioned.
As of September 30, 2021, the
Company had a cash balance of $14.5
million.
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 15,
2021
|
Time:
|
8:30 a.m.
ET
|
Toll free (U.S. and
International):
|
877-790-1503
|
Conference
ID:
|
13724324
|
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.
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 Company successfully completed Phase 1 and Phase 2a clinical
trials of ibezapolstat and in the second half of 2021 it expects to
begin enrollment of its Phase 2b
vancomycin-controlled efficacy study in a 1:1 randomized trial of a
total of 64 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 United States Food and Drug
Administration or equivalent foreign regulatory agencies where
approval is sought; whether, if ibezapolstat obtains approval, it
will be successfully distributed and marketed; and other factors.
In addition, the forward-looking statements included in this press
release represent our views as of November
12, 2021. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward- looking statements at some point in
the future, we specifically disclaim any obligation to do so.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President & Chief
Executive Officer
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
FINANCIAL TABLES FOLLOW
ACURX
PHARMACEUTICALS, INC.
CONDENSED INTERIM
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Nine Months Ended
|
|
September 30,
|
|
September 30,
|
|
2021
|
|
2020
|
|
2021
|
|
2020
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
Research and
Development
|
$
|
1,126,972
|
|
$
|
659,977
|
|
$
|
1,313,954
|
|
$
|
1,745,446
|
General and
Administrative
|
|
3,515,250
|
|
|
654,569
|
|
|
8,873,160
|
|
|
1,761,561
|
|
|
|
|
|
|
|
|
|
|
|
|
TOTAL OPERATING
EXPENSES
|
|
4,642,222
|
|
|
1,314,546
|
|
|
10,187,114
|
|
|
3,507,007
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on forgiveness
of Paycheck Protection Program Loan
|
|
—
|
|
|
—
|
|
|
66,503
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
$
|
(4,642,222)
|
|
$
|
(1,314,546)
|
|
$
|
(10,120,611)
|
|
$
|
(3,507,007)
|
|
|
|
|
|
|
|
|
|
|
|
|
LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share/units
|
$
|
(0.46)
|
|
$
|
(0.21)
|
|
$
|
(1.27)
|
|
$
|
(0.58)
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average pro
forma shares outstanding basic and diluted
|
|
10,116,403
|
|
|
6,266,584
|
|
|
7,988,563
|
|
|
6,037,254
|
ACURX
PHARMACEUTICALS, INC.
CONDENSED INTERIM
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
|
2021
|
|
2020
|
|
(unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
Cash
|
$
|
14,459,046
|
|
$
|
3,175,411
|
Prepaid
Expenses
|
|
530,582
|
|
|
48,609
|
TOTAL
ASSETS
|
$
|
14,989,628
|
|
$
|
3,224,020
|
|
|
|
|
|
|
LIABILITIES AND
MEMBERS' AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
Accounts Payable and
Accrued Expenses
|
$
|
712,437
|
|
$
|
455,931
|
Paycheck Protection
Program Loan
|
|
—
|
|
|
16,625
|
TOTAL CURRENT
LIABILITIES
|
|
712,437
|
|
|
472,556
|
|
|
|
|
|
|
NONCURRENT
LIABILITIES
|
|
|
|
|
|
Paycheck Protection
Program Loan
|
|
—
|
|
|
49,878
|
TOTAL
LIABILITIES
|
|
712,437
|
|
|
522,434
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
MEMBERS' AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
Members' Equity,
Class A
|
|
—
|
|
|
16,402,198
|
Members' Equity,
Class B
|
|
—
|
|
|
100,000
|
Common Stock; $.001
par value, 200,000,000 shares authorized,
10,126,903 shares issued and outstanding at September 30,
2021
|
|
10,127
|
|
|
—
|
Additional Paid-In
capital
|
|
38,188,287
|
|
|
—
|
Accumulated
Deficit
|
|
(23,921,223)
|
|
|
(13,800,612)
|
TOTAL MEMBERS' AND
SHAREHOLDERS' EQUITY
|
|
14,277,191
|
|
|
2,701,586
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
MEMBERS' AND SHAREHOLDERS' EQUITY
|
$
|
14,989,628
|
|
$
|
3,224,020
|
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SOURCE Acurx Pharmaceuticals, Inc.