STATEN
ISLAND, N.Y., May 12, 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 first quarter ended
March 31, 2023.
Highlights of the first quarter ended March 31, 2023
include:
- Acurx continues to enroll patients in its Phase 2b clinical trial, which now includes 28 U.S.
clinical trial sites, for patients with C. difficile
infection (CDI);
- The Phase 2b clinical trial will
compare the efficacy of oral ibezapolstat, the Company's lead
antibiotic candidate, to oral vancomycin, the current standard of
care for patients with CDI;
- In March 2023, the FDA accepted
the Company's protocol amendment to its Investigational New Drug
Application (or IND) which will allow an Independent Data
Monitoring Committee (or IDMC) to review interim clinical data upon
reaching 36 patients enrolled and to then provide its
recommendation either to early terminate the Ph2b trial, as the
Company had done with the Ph2a trial, or alternatively continue
enrolling. We anticipate completing enrollment of the 36 patients
in the second half of 2023;
- In April 2023 two presentations
were made at the 33rd Annual European Congress of Clinical
Microbiology and Infectious Disease (ECCMID) in Copenhagen. First, a scientific poster
entitled "Novel Pharmacology and Susceptibility of Ibezapolstat
Against C. difficile Isolates with Reduced Susceptibility to C.
difficile-directed Antibiotics" was presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy, and
Principal Investigator for microbiome aspects of our ibezapolstat
clinical trial program. Second, Acurx Executive Chairman,
Bob DeLuccia, presented an update
regarding the Company's preclinical, systemic oral and IV program
for treatment of other gram-positive infections caused by MRSA, VRE
and DRSP at the "Pipeline Corner" featured session at ECCMID,
organized by Dr. Ursula Theuretzbacher, a world-renowned
microbiology expert involved in antibacterial drug research,
discovery and development strategies and policies for clinical and
public health needs. These presentations are available on the
Company's website at www.acurxpharma.com .
- The Company is continuing its R&D collaboration with Leiden
University Medical Center (Holland) under a previously awarded grant from
the Dutch Government of approximately $500,000 USD 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 pipeline
for the systemic treatment (IV and oral) of gram-positive bacterial
infections. The Company is currently in active discussions to
extend this research program for an additional two-year
period;
- Regarding the Company's open application for a non-dilutive
grant to CARB-X, the Company was recently informed by CARB-X that
its application is in the active review pool and a final decision
is to be rendered by CARB-X in or prior to October 2023. We believe that based on our recent
development progress and the unique nature of having a new class of
antibiotics, we have a strong possibility to obtain CARB-X
approval;
First Quarter 2023 Financial Results
- Cash Position:
The Company ended the quarter, with cash totaling $7.2 million compared to $9.1 million as of December 31, 2022.
- R&D Expenses:
Research and development expenses for the three months ended
March 31, 2023 were $1.0 million compared to $0.8 million for the three months ended
March 31, 2022. The increase was due
to an increase in Phase 2b trial
related costs.
- G&A Expenses:
General and administrative expenses for the three months ended
March 31, 2023 were $1.9 million compared to $1.9 million for the three months ended
March 31, 2022.
- Net Income/Loss:
The Company reported a net loss of $2.9
million or $0.25 per diluted
share for the three months ended March 31,
2023 compared to a net loss of $2.7
million or $0.26 per diluted
share for the three months ended March 31,
2022 for the reasons previously mentioned.
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:
|
Friday, May 12,
2023
|
Time:
|
8:00 a.m. ET
|
Toll free (U.S. and
International):
|
877-790-1503
|
Conference
ID:
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13738523
|
About the Ibezapolstat Phase 2 Clinical Trial
The
completed multicenter, open-label single-arm segment (Phase 2a)
study is now 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 is 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 currently enrolling
Phase 2b, trial segment, patients
with CDI will be 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 will be 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 continue to 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. In the event non-inferiority of ibezapolstat to
vancomycin is demonstrated, further analysis will be conducted to
test for superiority.
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.
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 March 16,
2023. 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.
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.
|
CONDENSED INTERIM
BALANCE SHEETS
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2023
|
|
2022
|
|
|
(unaudited)
|
|
(Note
2)
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS
|
|
|
|
|
|
|
Cash
|
|
$
|
7,178,820
|
|
$
|
9,111,751
|
Prepaid
Expenses
|
|
|
206,601
|
|
|
264,955
|
TOTAL
ASSETS
|
|
$
|
7,385,421
|
|
$
|
9,376,706
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts Payable and
Accrued Expenses
|
|
$
|
2,073,982
|
|
$
|
2,061,685
|
TOTAL CURRENT
LIABILITIES
|
|
|
2,073,982
|
|
|
2,061,685
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
|
2,073,982
|
|
|
2,061,685
|
|
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY
|
|
|
|
|
|
|
Common Stock; $.001 par
value, 200,000,000 shares authorized,
11,671,795 and 11,627,609 shares issued and outstanding at
March 31, 2023 and December 31, 2022,
respectively
|
|
|
11,672
|
|
|
11,628
|
Additional Paid-In
Capital
|
|
|
46,843,809
|
|
|
45,944,478
|
Accumulated
Deficit
|
|
|
(41,544,042)
|
|
|
(38,641,085)
|
|
|
|
|
|
|
|
TOTAL SHAREHOLDERS'
EQUITY
|
|
|
5,311,439
|
|
|
7,315,021
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
$
|
7,385,421
|
|
$
|
9,376,706
|
ACURX
PHARMACEUTICALS, INC.
|
CONDENSED INTERIM
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March 31,
|
|
|
|
2023
|
|
2022
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and
Development
|
|
$
|
1,015,583
|
|
$
|
818,888
|
|
General and
Administrative
|
|
|
1,887,374
|
|
|
1,851,250
|
|
|
|
|
|
|
|
|
|
TOTAL OPERATING
EXPENSES
|
|
|
2,902,957
|
|
|
2,670,138
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(2,902,957)
|
|
$
|
(2,670,138)
|
|
|
|
|
|
|
|
|
|
LOSS PER
SHARE
|
|
|
|
|
|
|
|
Basic and diluted net
loss per common share
|
|
$
|
(0.25)
|
|
$
|
(0.26)
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding basic and diluted
|
|
|
11,639,395
|
|
|
10,232,843
|
|
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SOURCE Acurx Pharmaceuticals, Inc.