Acurx Pharmaceuticals, Inc. Reports Second Quarter 2023 Results and Provides Business Update
- Acurx continues to enroll patients in its Phase 2b clinical trial for C. difficile infection
- Acurx anticipates completing enrollment of the required patients in the coming months
- The company announced upcoming presentations at two scientific conferences
- Acurx is continuing its R&D collaboration with Leiden University Medical Center
- The company's application for a non-dilutive grant was not approved by CARB-X
- Increased R&D and G&A expenses
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 ofHouston 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 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;$500,000 USD - 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 compared to$9.1 million as of December 31, 2022.$9.1 million - R&D Expenses:
Research and development expenses for the three months ended June 30, 2023 were compared to$1.7 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$0.9 million compared to$2.8 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.$1.7 million - G&A Expenses:
General and administrative expenses for the three months ended June 30, 2023 were compared to$1.7 million for the three months ended June 30, 2022. Professional fees decreased by$1.7 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$0.1 million compared to$3.6 million for the six months ended June 30, 2022. Professional fees decreased by$3.6 million , offset by an increase of$0.2 million in employee related compensation costs.$0.2 million - Net Income/Loss:
The Company reported a net loss of or$3.4 million per diluted share for the three months ended June 30, 2023, compared to a net loss of$0.28 or$2.6 million per diluted share for the three months ended June 30, 2022, and a net loss of$0.26 or$6.3 million per diluted share for the six months ended June 30, 2023, compared to a net loss of$0.53 or$5.3 million per diluted share for the six months ended June 30, 2022 for the reasons previously mentioned.$0.52
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: | Monday, August 14, 2023 |
Time: | 8:00 a.m. ET |
Toll free ( | 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
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
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. | ||||||
CONDENSED INTERIM BALANCE SHEETS | ||||||
June 30, | December 31, | |||||
2023 | 2022 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 9,145,835 | $ | 9,111,751 | ||
Prepaid Expenses | 89,942 | 264,955 | ||||
TOTAL ASSETS | $ | 9,235,777 | $ | 9,376,706 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
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 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; | 13,005 | 11,628 | ||||
Additional Paid-In Capital | 51,192,646 | 45,944,478 | ||||
Accumulated Deficit | (44,989,282) | (38,641,085) | ||||
TOTAL SHAREHOLDERS' EQUITY | 6,216,369 | 7,315,021 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 9,235,777 | $ | 9,376,706 |
ACURX PHARMACEUTICALS, INC. | |||||||||||||
CONDENSED INTERIM STATEMENTS OF OPERATIONS | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES | |||||||||||||
Research and Development | $ | 1,736,386 | $ | 911,692 | $ | 2,751,969 | $ | 1,730,580 | |||||
General and Administrative | 1,708,854 | 1,708,841 | 3,596,228 | 3,560,090 | |||||||||
TOTAL OPERATING EXPENSES | 3,445,240 | 2,620,533 | 6,348,197 | 5,290,670 | |||||||||
NET LOSS | $ | (3,445,240) | $ | (2,620,533) | $ | (6,348,197) | $ | (5,290,670) | |||||
LOSS PER SHARE | |||||||||||||
Basic and diluted net loss per common | $ | (0.28) | $ | (0.26) | $ | (0.53) | $ | (0.52) | |||||
Weighted average common shares | 12,186,481 | 10,263,202 | 11,914,449 | 10,248,107 |
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SOURCE Acurx Pharmaceuticals, Inc.
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