Acurx Pharmaceuticals, Inc. Reports Fourth Quarter and Full Year 2022 Results and Provides Business Update Staten Island, NY

Acurx Pharmaceuticals, Inc. Reports Fourth Quarter

Full Year 2022 Results and Provides Business Update

Staten Island, NY, March 16, 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 fourth quarter

and full year ended December 31, 2022.

Highlights of the fourth quarter and full year

ended December 31, 2022 include:

Fourth Quarter and Full Year 2022 Financial Results

The Company ended the year, with cash totaling $9.1 million

compared to $13.0 million as of December 31, 2021.

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.

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.

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.

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:

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

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,