STATEN
ISLAND, N.Y., Aug. 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 second
quarter ended June 30,
2023.
Highlights of the second quarter ended June 30, 2023
include:
- Acurx continues to enroll patients in its Phase 2b clinical trial, which 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;
- Acurx anticipates completing enrollment of the 36 patients
required for an interim review of the Phase 2b data by a newly appointed Independent Data
Monitoring Committee (IDMC) in the coming months, with only 5
patients to enroll forward;
- 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 .
- Acurx announced that it has been approved for presentations in
2H 2023 at two of the most prestigious scientific conferences in
our sector; namely, the World Antimicrobial Resistance Conference
(Philadelphia, PA) in September 2023 as well as at ID Week sponsored by
the Infectious Disease Society of America (Boston, MA) in October
2023.
- 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 was notified by CARB-X that its application for a
non-dilutive grant to fund its pre-clinical antibiotic candidate,
ACX375C, was not approved. CARB-X noted that the 2023 round of
funding was very competitive and that their Scientific Advisory
Board was enthusiastic about pol IIIC as the bacterial target of
our molecules and that the sufficiently good PK and safety
properties of the compounds justified the proposed lead
optimization plan. CARB-X encouraged us to re-apply for potential
future requests for proposals or RFPs that CARB-X will continue to
promulgate from time to time for CARB-X funding consideration.
Second Quarter 2023 Financial Results
- Cash Position:
The Company ended the second quarter with cash totaling
$9.1 million compared to $9.1 million as of December 31, 2022.
- R&D Expenses:
Research and development expenses for the three months ended
June 30, 2023 were $1.7 million compared to $0.9 million for the three months ended
June 30, 2022. The increase was due
to an increase in Phase 2b trial
related costs. For the six months ended June
30, 2023 research and development expenses were $2.8 million compared to $1.7 million for the six months ended
June 30, 2022. The increase is due
primarily to an increase in Phase 2b
trial related costs and an increase in consulting costs.
- G&A Expenses:
General and administrative expenses for the three months ended
June 30, 2023 were $1.7 million compared to $1.7 million for the three months ended
June 30, 2022. Professional fees
decreased by $0.1 million, offset by
an increase of $0.1 million in
employee related compensation costs. For the six months ended
June 30, 2023, general and
administrative expenses were $3.6
million compared to $3.6
million for the six months ended June
30, 2022. Professional fees decreased by $0.2 million, offset by an increase of
$0.2 million in employee related
compensation costs.
- Net Income/Loss:
The Company reported a net loss of $3.4
million or $0.28 per diluted
share for the three months ended June 30,
2023, compared to a net loss of $2.6
million or $0.26 per diluted
share for the three months ended June 30,
2022, and a net loss of $6.3
million or $0.53 per diluted
share for the six months ended June 30,
2023, compared to a net loss of $5.3
million or $0.52 per diluted
share for the six months ended June 30,
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:
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Monday, August 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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13740293
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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 August 14,
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.
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CONDENSED INTERIM
BALANCE SHEETS
|
|
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|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2023
|
|
2022
|
|
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(unaudited)
|
|
(Note
2)
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ASSETS
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|
|
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CURRENT
ASSETS
|
|
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|
|
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Cash
|
|
$
|
9,145,835
|
|
$
|
9,111,751
|
Prepaid
Expenses
|
|
|
89,942
|
|
|
264,955
|
TOTAL
ASSETS
|
|
$
|
9,235,777
|
|
$
|
9,376,706
|
|
|
|
|
|
|
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LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
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|
CURRENT
LIABILITIES
|
|
|
|
|
|
|
Accounts Payable and
Accrued Expenses
|
|
$
|
3,019,408
|
|
$
|
2,061,685
|
TOTAL CURRENT
LIABILITIES
|
|
|
3,019,408
|
|
|
2,061,685
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES
|
|
|
3,019,408
|
|
|
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
June 30, 2023 and December 31, 2022,
respectively
|
|
|
13,005
|
|
|
11,628
|
Additional Paid-In
Capital
|
|
|
51,192,646
|
|
|
45,944,478
|
Accumulated
Deficit
|
|
|
(44,989,282)
|
|
|
(38,641,085)
|
|
|
|
|
|
|
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TOTAL SHAREHOLDERS'
EQUITY
|
|
|
6,216,369
|
|
|
7,315,021
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
$
|
9,235,777
|
|
$
|
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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|
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|
|
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Three Months
Ended
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|
Six Months
Ended
|
|
|
|
June 30,
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June 30,
|
|
|
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2023
|
|
2022
|
|
2023
|
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2022
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
|
|
(unaudited)
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OPERATING
EXPENSES
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|
|
|
|
|
|
|
|
|
|
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Research and
Development
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$
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1,736,386
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$
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911,692
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$
|
2,751,969
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$
|
1,730,580
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General and
Administrative
|
|
|
1,708,854
|
|
|
1,708,841
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|
|
3,596,228
|
|
|
3,560,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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TOTAL OPERATING
EXPENSES
|
|
|
3,445,240
|
|
|
2,620,533
|
|
|
6,348,197
|
|
|
5,290,670
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|
|
|
|
|
|
|
|
|
|
|
|
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NET LOSS
|
|
$
|
(3,445,240)
|
|
$
|
(2,620,533)
|
|
$
|
(6,348,197)
|
|
$
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(5,290,670)
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|
|
|
|
|
|
|
|
|
|
|
|
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LOSS PER
SHARE
|
|
|
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|
|
|
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Basic and diluted net
loss per common
share
|
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$
|
(0.28)
|
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$
|
(0.26)
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$
|
(0.53)
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$
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(0.52)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares
outstanding basic and diluted
|
|
|
12,186,481
|
|
|
10,263,202
|
|
|
11,914,449
|
|
|
10,248,107
|
|
View original
content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-second-quarter-2023-results-and-provides-business-update-301899293.html
SOURCE Acurx Pharmaceuticals, Inc.