STATEN
ISLAND, N.Y., Nov. 14,
2023 /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 third quarter ended
September 30, 2023.
Highlights of the third quarter ended September 30, 2023, and in some cases shortly
thereafter, include:
On October 2, 2023, Acurx ended
enrollment in its Phase 2b clinical
trial of ibezapolstat, its lead antibiotic candidate, for the
treatment of patients with C. difficile infection, or CDI;
On November 2, 2023, Acurx
reported top-line data from the Phase 2 clinical trial including
the ibezapolstat clinical cure rate at end of treatment, or EOT, of
96% (25/26) including 100% in Phase 2a (10/10) and 94% in Phase
2b (15/16) as well as the cure rate
for oral vancomycin at EOT of 100% (14/14);
Ibezapolstat will now move forward to Phase 3 clinical trials.
Preparation underway for End-of-Phase 2 FDA Meeting and advancement
to Phase 3
No safety concerns were reported in either arm of the Phase
2b clinical trial or in the Phase 2a
open label trial;
In consultation with its scientific advisors, the Company
determined that clear evidence of clinical cure was established
with ibezapolstat and ibezapolstat is clinically comparable to
vancomycin, the standard of care to treat CDI;
Further data will be provided when available on all of the
secondary and exploratory endpoints in the Phase 2b trial, including sustained clinical cure data,
extended clinical cure data up to 94 days and impact on the
microbiome when compared to vancomycin.
The Company anticipates that these secondary and exploratory
endpoints will provide clear separation between these two
therapeutic options and provide validation for front-line use of
ibezapolstat to treat patients with CDI;.
In September 2023, the World
Antimicrobial Resistance (AMR) Congress convened its annual meeting
in Philadelphia where experts in
the field from both the public and private sectors weighed in on
the latest innovations to address AMR. Our Executive Chairman,
Bob DeLuccia, presented an update
entitled: "Novel DNA pol IIIC Inhibitors for Gram-positive
Bacterial Infections: Preparing for the Next Pandemic".
The IDSA (Infectious Diseases Society of America) convened its
annual meeting, called ID Week, in Boston from October
11-15, 2023. Acurx was featured at two scheduled
events:
First, an oral presentation by Dr. Kevin
Garey, Professor and Chair, University
of Houston College of Pharmacy, and the Principal
Investigator for microbiome aspects of our ibezapolstat clinical
trial program, was given on October
14 entitled: Elucidating the Gram-Positive Selective
Spectrum Activity of Ibezapolstat; Secondary Analysis from the
phase 2a trial.
Second, Acurx presented at the symposium entitled, "New
Antimicrobials in the Pipeline" on October
12. At the symposium, Acurx presentation was entitled:
"Novel DNA pol IIIC Inhibitors for Gram-positive Bacterial
Infections."
Three scientific posters were presented during the CLOSTPATH
conference held in Banff, Canada
from September 19 to 23, 2023 and
provided new information further supporting ibezapolstat's unique
pharmacologic profile:
The first entitled: "Ibezapolstat modulates Clostridioides
difficile virulence factors in vitro" showed
Ibezapolstat reduces toxin production by the C. difficile
bacteria…
The second entitled: "C. difficile In Vitro Biofilm Studies of
Ibezapolstat And Comparator Antibiotics" showed
ibezapolstat was as effective as the
currently-used anti-C. difficile antibiotics
fidaxomicin, vancomycin and metronidazole in
reducing reduce biofilm-embedded C. difficile…
The third entitled: "Metagenomic Evaluation of Ibezapolstat
Compared to Other Anti-C. difficile Agents" showed
ibezapolstat and fidaxomicin both caused favorable
proportional increases in Bacteroidetes but distinct
from vancomycin and metronidazole, which caused
unfavorable proportional increases in Proteobacteria.
All the presentations described above are available on our
website.
Third Quarter 2023 Financial Results
Cash Position:
The Company ended the third quarter
with cash totaling $7.1 million,
compared to $9.1 million as of
December 31, 2022. After the
quarter end, the Company received an additional $2.2 million in cash associated with the
conversion of approximately 680,000 warrants, which resulted in the
issuance of approximately 680,000 shares.
R&D Expenses:
Research and development expenses
for the three months ended September 30,
2023, were $1.3 million
compared to $1.6 million for the
three months ended September 30,
2022. The decrease was due to the timing of Phase
2b trial related costs. For the
nine months ended September 30, 2023,
research and development expenses were $4.1 million versus $3.3 million for the nine months ended
September 30, 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 September 30,
2023, were $1.8 million
compared to $2.0 million for the
three months ended September 30,
2022. The decrease was due primarily to a $0.2 million decrease in professional fees.
For the nine months ended September 30,
2023, general and administrative expenses were $5.4 million versus $5.5 million for the nine months ended
September 30, 2022. The amounts
reflect a decrease in professional fees of $0.3 million, offset by an increase of
$0.2 million in share-based
compensation.
Net Loss:
The Company reported a net loss of
$3.1 million or $0.24 per diluted share for the three months
ended September 30, 2023 compared to
a net loss of $3.5 million or
$0.32 per diluted share for the three
months ended September 30, 2022, and
a net loss of $9.5 million or
$0.77 per share for the nine months
ended September 30, 2023, compared to
a net loss of $8.8 million or
$0.84 per diluted share for the nine
months ended September 30, 2022 for
the reasons previously mentioned.
The Company had 13,005,128 shares outstanding as of September 30, 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:
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Tuesday, November 14,
2023
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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
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Conference
ID:
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13742354
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About the Ibezapolstat Phase 2
Clinical Trial
On November 2, 2023, we reported
top-line data from the Phase 2 clinical trial including the
ibezapolstat clinical cure rate at end of treatment, or EOT, of 96%
(25/26) including 100% in Phase 2a (10/10) and 94% in Phase
2b (15/16) as well as the cure rate
for oral vancomycin at EOT of 100% (14/14). No safety
concerns were reported in either arm of the Phase 2b clinical trial or in the Phase 2a open label
trial. In consultation with its scientific advisors, the
Company has determined that clear evidence of clinical cure has
been established with ibezapolstat and is clinically comparable to
vancomycin. Ibezapolstat will now move forward to Phase 3 clinical
trials. Further data will be provided when available on all of the
secondary and exploratory endpoints in the Phase 2b trial, including sustained clinical cure data,
extended clinical cure data up to 94 days and impact on the
microbiome compared to vancomycin.We anticipate that these
secondary and exploratory endpoints will provide clear separation
between these two therapeutic options.
The completed multicenter, open-label single-arm segment (Phase
2a) study was followed by a double-blind, randomized,
active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together
comprise the Phase 2 clinical trial (see
https://clinicaltrials.gov/ct2/show/NCT04247542).
This Phase 2 clinical trial was designed to evaluate the
clinical efficacy of ibezapolstat in the treatment of CDI including
pharmacokinetics and microbiome changes from baseline and continue
to test for anti-recurrence microbiome properties seen in the Phase
2a trial, including the treatment-related changes in alpha
diversity and bacterial abundance and effects on bile acid
metabolism.
The completed Phase 2a segment of this trial was an open label
cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients
with diarrhea caused by C. difficile were treated with ibezapolstat
450 mg orally, twice daily for 10 days. All patients were followed
for recurrence for 28± 2 days. Per protocol, after 10 patients of
the projected 20 Phase 2a patients completed treatment (100% cured
infection at End of Treatment), the Trial Oversight Committee
assessed the safety and tolerability and made its recommendation
regarding early termination of the Phase 2a study and advancement
to the Ph2b segment. In the now completed Phase 2b trial segment, 32 patients with CDI were
enrolled and randomized in a 1:1 ratio to either ibezapolstat 450
mg every 12 hours or vancomycin 125 mg orally every 6 hours, in
each case, for 10 days and followed for 28 ± 2 days following the
end of treatment for recurrence of CDI. The two treatments were
identical in appearance, dosing times, and number of capsules
administered to maintain the blind. This Phase 2 clinical trial
will also evaluate pharmacokinetics (PK) and microbiome changes and
test for anti-recurrence microbiome properties, including the
change from baseline in alpha diversity and bacterial abundance,
especially overgrowth of healthy gut microbiota Actinobacteria and
Firmicute phylum species during and after therapy.
Phase 2a data demonstrated complete eradication of colonic C.
difficile by day three of treatment with ibezapolstat as well as
the observed overgrowth of healthy gut microbiota, Actinobacteria
and Firmicute phyla species, during and after therapy. Very
importantly, emerging data show an increased concentration of
secondary bile acids during and following ibezapolstat therapy
which is known to correlate with colonization resistance against C.
difficile. A decrease in primary bile acids and the favorable
increase in the ratio of secondary-to-primary bile acids suggest
that ibezapolstat may reduce the likelihood of CDI recurrence when
compared to vancomycin.
About the Microbiome in Clostridioides difficile
Infection (CDI) and Bile Acid Metabolism
C. difficile can be a normal component of the healthy gut
microbiome, but when the microbiome is thrown out of balance, the
C. difficile can thrive and cause an infection. After colonization
with C. difficile, the organism produces and releases the main
virulence factors, the two large clostridial toxins A (TcdA) and B
(TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200;
doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins
that bind to human intestinal epithelial cells and are responsible
for inflammation, fluid and mucous secretion, as well as damage to
the intestinal mucosa.
Bile acids perform many functional roles in the GI tract, with
one of the most important being maintenance of a healthy microbiome
by inhibiting C. difficile growth. Primary bile acids, which are
secreted by the liver into the intestines, promote germination of
C. difficile spores and thereby increase the risk of recurrent CDI
after successful treatment of an initial episode. On the other
hand, secondary bile acids, which are produced by normal gut
microbiota through metabolism of primary bile acids, do not induce
C. difficile sporulation and therefore protect against recurrent
disease. Since ibezapolstat treatment leads to minimal disruption
of the gut microbiome, bacterial production of secondary bile acids
continues which may contribute to an anti-recurrence effect.
About Clostridioides difficile Infection (CDI)
According to the 2017 Update (published February 2018) of the Clinical Practice
Guidelines for C. difficile Infection by the Infectious Diseases
Society of America (IDSA) and Society or Healthcare Epidemiology of
America (SHEA), CDI remains a significant medical problem in
hospitals, in long term care facilities and in the community. C.
difficile is one of the most common causes of health care-
associated infections in U.S. hospitals (Lessa, et al, 2015, New
England Journal of Medicine). Recent estimates suggest C. difficile
approaches 500,000 infections annually in the U.S. and is
associated with approximately 20,000 deaths annually. (Guh, 2020,
New England Journal of Medicine). Based on internal estimates, the
recurrence rate of two of the three antibiotics currently used to
treat CDI is between 20% and 40% among approximately 150,000
patients treated. We believe the annual incidence of CDI in the
U.S. approaches 600,000 infections and a mortality rate of
approximately 9.3%.
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 early-stage 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,
2022, 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.
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CONDENSED INTERIM
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
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September 30,
|
|
December 31,
|
|
|
2023
|
|
2022
|
|
|
(unaudited)
|
|
(Note
2)
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ASSETS
|
|
|
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|
|
|
|
|
|
|
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CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$
|
7,052,329
|
|
$
|
9,111,751
|
Prepaid
Expenses
|
|
|
105,722
|
|
|
264,955
|
TOTAL ASSETS
|
|
$
|
7,158,051
|
|
$
|
9,376,706
|
|
|
|
|
|
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LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts Payable and
Accrued Expenses
|
|
$
|
3,223,378
|
|
$
|
2,061,685
|
TOTAL CURRENT
LIABILITIES
|
|
|
3,223,378
|
|
|
2,061,685
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
|
3,223,378
|
|
|
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,
13,005,128 and 11,627,609 shares issued and outstanding at
September 30, 2023 and December 31, 2022,
respectively
|
|
|
13,005
|
|
|
11,628
|
Additional Paid-In
Capital
|
|
|
52,025,931
|
|
|
45,944,478
|
Accumulated
Deficit
|
|
|
(48,104,263)
|
|
|
(38,641,085)
|
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS'
EQUITY
|
|
|
3,934,673
|
|
|
7,315,021
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
$
|
7,158,051
|
|
$
|
9,376,706
|
ACURX
PHARMACEUTICALS, INC.
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|
CONDENSED INTERIM
STATEMENTS OF OPERATIONS
|
|
|
|
|
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|
|
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|
|
|
|
|
|
|
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Three Months
Ended
|
|
Nine Months
Ended
|
|
|
|
September 30,
|
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September 30,
|
|
|
|
2023
|
|
2022
|
|
2023
|
|
2022
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
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OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
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Research and
Development
|
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$
|
1,348,985
|
|
$
|
1,591,043
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|
$
|
4,100,954
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|
$
|
3,321,623
|
|
General and
Administrative
|
|
|
1,765,996
|
|
|
1,950,551
|
|
|
5,362,224
|
|
|
5,510,642
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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TOTAL OPERATING
EXPENSES
|
|
|
3,114,981
|
|
|
3,541,594
|
|
|
9,463,178
|
|
|
8,832,265
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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NET LOSS
|
|
$
|
(3,114,981)
|
|
$
|
(3,541,594)
|
|
$
|
(9,463,178)
|
|
$
|
(8,832,265)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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LOSS PER
SHARE
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net
loss per common share
|
|
$
|
(0.24)
|
|
$
|
(0.32)
|
|
$
|
(0.77)
|
|
$
|
(0.84)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding
basic and diluted
|
|
|
13,005,128
|
|
|
11,148,402
|
|
|
12,282,004
|
|
|
10,551,503
|
|
View original
content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-third-quarter-2023-results-and-provides-business-update-301985362.html
SOURCE Acurx Pharmaceuticals, Inc.