STATEN
ISLAND, N.Y., March 16,
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 fourth
quarter and full year ended December
31, 2022.
Highlights of the fourth quarter and full year ended December
31, 2022 include:
- Acurx continues to enroll patients in its Phase 2b clinical trial, which includes 28 U.S. sites
(up from the initial 12 clinical trial sites), in patients with C.
difficile infection (CDI) with an interim review of clinical
data anticipated in mid-2023;
- 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 CDI;
- Based on the blinded observed data from the ongoing Ph2b
clinical trial to date, in January
2023, the Company filed a protocol amendment to its
Investigational New Drug Application (IND) with FDA to allow for an
Independent Data Monitoring Committee (IDMC) to review interim
clinical data. If acceptable to FDA, the IDMC will review the
clinical data upon enrollment of 36 patients in the Ph2b clinical
trial. The Company currently has enrolled 25 patients in the Ph2b
clinical trial. The IDMC will determine and recommend to the
Company whether the most appropriate course of action forward is to
early terminate the Ph2b clinical trial (as the Company had done
with the Ph2a clinical trial) or to continue patient enrollment.
The Company intends to report available data promptly after the
IDMC conducts this interim review. The Company assembled its IDMC
during this first quarter of 2023 for this purpose.
- 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. Data generated from this
program was critical to include in a recent grant application for
$11.3 million of non-dilutive funding
(described below) with a decision anticipated in April 2023. Based on this successful
collaboration, LUMC has proposed a second-stage, two-year project
to further analyze chemical structure relationships of new Acurx
compounds with a propensity for reduced antimicrobial resistance.
At this point, this new project proposal is subject to review,
approval and funding by the Dutch government for an additional
$500,000 and the Company anticipates
a decision by mid-2023;
- The Company 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.
Comparisons of the killing effect of ibezapolstat to fidaxomicin
and metronidazole are ongoing. These reported clinical results
support the expectation that microbiome effects may be predictive
of beneficial patient outcomes including low rates of
recurrence;
- In October 2022, the Company
filed for a non-dilutive grant of up to $11.3 million which, if approved, would provide
funding for ACX-375, our second antibiotic program targeting the
treatment of MRSA infections, for a period of 5 years up to the
start of Ph2 clinical trials. The Company is now in the third and
final round of consideration for this non-dilutive grant and a
decision is expected in April 2023.
If approved, the Company would need to pay approximately
$5 million of the approximate
$16 million program total cost over a
five-year period with approximately $11.3
million paid by the grant provider;
- Next month, the European Congress of Clinical Microbiology and
Infectious Disease (commonly referred to as ECCMID), one of the
most comprehensive and influential scientific conferences in
clinical microbiology and infection, will hold its 33rd session in
Copenhagen. An abstract entitled
"Novel pharmacology and susceptibility of ibezapolstat against
C. difficile isolates with reduced susceptibility to C.
difficile-directed antibiotics" has been accepted. 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, will present on our
behalf;
- Additionally, our Executive Chairman, Robert J. DeLuccia, has been invited to present
the Company's preclinical, systemic oral and IV program for
treatment of other gram-positive infections caused by MRSA, VRE and
DRSP in their "Pipeline Corner" featured session at ECCMID,
organized by Dr. Ursula Theuretzbacher, a world-renowned
microbiology expert for antibacterial drug research, discovery and
development strategies and policies for clinical and public health
needs. More details on these presentations will be announced prior
to the meeting date.
Fourth Quarter and Full Year 2022 Financial
Results
- Cash Position:
The Company ended the year, with cash totaling $9.1 million compared to $13.0 million as of December 31, 2021.
- R&D Expenses:
Research and development expenses for the three months ended
December 31, 2022 were $1.4 million compared to $0.7 million for the three months ended
December 31, 2021. The increase was
due to an increase in Phase 2b trial
related costs. For the twelve months ended December 31, 2022, research and development
expenses were $4.8 million versus
$2.0 million for the twelve months
ended December 31, 2021. This
increase was due primarily to Phase 2b trial related costs.
- G&A Expenses:
General and administrative expenses for the three months ended
December 31, 2022 were $1.8 million compared to $1.9 million for the three months ended
December 31, 2021. The decrease was
primarily due to a decrease in professional fees. For the twelve
months ended December 31, 2022,
general and administrative expenses were $7.3 million versus $10.8
million for the twelve months ended December 31, 2021. The decrease was primarily
attributable to a decrease in professional fees and stock-based
compensation, partially offset by an increase in insurance
costs.
- Net Income/Loss:
The Company reported a net loss of $3.3
million or $0.28 per diluted
share for the three months ended December
31, 2022 compared to a net loss of $2.6 million or $0.26 per diluted share for the three months
ended December 31, 2021, and a net
loss of $12.1 million or $1.12 per share for the twelve months ended
December 31, 2022, compared to a net
loss of $12.7 million or $1.49 per diluted share for the twelve months
ended December 31, 2021 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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Thursday, March 16,
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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13736887
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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 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.
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BALANCE SHEETS
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AS OF DECEMBER 31, 2022 AND
2021
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December 31,
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December 31,
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2022
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2021
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ASSETS
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CURRENT
ASSETS
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Cash
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$
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9,111,751
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$
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12,958,846
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Prepaid
Expenses
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264,955
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295,304
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TOTAL ASSETS
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$
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9,376,706
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$
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13,254,150
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LIABILITIES AND
MEMBERS' 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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2,061,685
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$
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843,909
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TOTAL CURRENT
LIABILITIES
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2,061,685
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843,909
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TOTAL
LIABILITIES
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2,061,685
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843,909
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COMMITMENTS AND
CONTINGENCIES
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MEMBERS' AND
SHAREHOLDERS' EQUITY
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Members' Equity, Class
A
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—
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—
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Members' Equity, Class
B
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|
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—
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—
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Common Stock; $.001 par
value, 200,000,000 shares authorized, 11,627,609 and
10,215,792 shares issued and outstanding at
December 31, 2022 and 2021,
respectively
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11,628
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10,216
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Additional Paid-In
Capital
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45,944,478
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38,948,334
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Accumulated
Deficit
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(38,641,085)
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(26,548,309)
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TOTAL MEMBERS' AND
SHAREHOLDERS' EQUITY
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7,315,021
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12,410,241
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TOTAL LIABILITIES AND
MEMBERS' AND SHAREHOLDERS' EQUITY
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$
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9,376,706
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$
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13,254,150
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ACURX PHARMACEUTICALS, INC.
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STATEMENTS OF OPERATIONS
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YEARS ENDED DECEMBER 31, 2022 AND
2021
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2022
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2021
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OPERATING
EXPENSES
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Research and
Development
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$
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4,754,271
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$
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2,030,177
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General and
Administrative
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7,338,505
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10,784,023
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TOTAL OPERATING
EXPENSES
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12,092,776
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12,814,200
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Gain on Forgiveness of
Paycheck Protection Program Loan
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—
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66,503
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NET LOSS
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$
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(12,092,776)
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$
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(12,747,697)
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LOSS PER
SHARE
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Basic and diluted net
loss per common share
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$
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(1.12)
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$
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(1.49)
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Weighted average common
shares outstanding basic and diluted
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10,816,412
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8,535,873
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SOURCE Acurx Pharmaceuticals, Inc.