Full Press Release Details
For Immediate Release - 7:01 am ET on Monday, August 14,
Acurx Pharmaceuticals, Inc. Reports Second
Quarter 2023 Results and Provides Business Update
Staten Island, NY, August 14, 2023 - 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,
Second Quarter 2023 Financial Results
The Company ended the second quarter with cash totaling $9.1
million compared to $9.1 million as of December 31, 2022.
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.
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.
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.
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
| Date: | Monday, August 14, 2023 |
| Time: | 8:00 a.m. ET |
| Toll free (U.S. and International): | 877-790-1503 |
| Conference ID: | 13740293 |
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
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