Acurx Pharmaceuticals, Inc. Reports Third Quarter 2023 Results and Provides Business Update
- Completion of Phase 2b clinical trial for ibezapolstat with a 96% clinical cure rate is a positive sign for the company's antibiotic candidate.
- No safety concerns reported in the trial, indicating the potential for ibezapolstat to be clinically comparable to vancomycin, the standard of care for CDI.
- Presentation at major industry conferences demonstrates Acurx's active involvement in the scientific community, potentially enhancing its reputation and network within the industry.
- Improvement in net loss from the previous year indicates a positive trend in the company's financial performance.
- None.
Highlights of the third quarter ended September 30, 2023, and in some cases shortly thereafter, include:
On October 2, 2023, Acurx ended enrollment in its Phase 2b clinical trial of ibezapolstat, its lead antibiotic candidate, for the treatment of patients with C. difficile infection, or CDI;
On November 2, 2023, Acurx reported top-line data from the Phase 2 clinical trial including the ibezapolstat clinical cure rate at end of treatment, or EOT, of
Ibezapolstat will now move forward to Phase 3 clinical trials. Preparation underway for End-of-Phase 2 FDA Meeting and advancement to Phase 3
No safety concerns were reported in either arm of the Phase 2b clinical trial or in the Phase 2a open label trial;
In consultation with its scientific advisors, the Company determined that clear evidence of clinical cure was established with ibezapolstat and ibezapolstat is clinically comparable to vancomycin, the standard of care to treat CDI;
Further data will be provided when available on all of the secondary and exploratory endpoints in the Phase 2b trial, including sustained clinical cure data, extended clinical cure data up to 94 days and impact on the microbiome when compared to vancomycin.
The Company anticipates that these secondary and exploratory endpoints will provide clear separation between these two therapeutic options and provide validation for front-line use of ibezapolstat to treat patients with CDI;.
In September 2023, the World Antimicrobial Resistance (AMR) Congress convened its annual meeting in
The IDSA (Infectious Diseases Society of America) convened its annual meeting, called ID Week, in
First, an oral presentation by Dr. Kevin Garey, Professor and Chair, University of
Second, Acurx presented at the symposium entitled, "New Antimicrobials in the Pipeline" on October 12. At the symposium, Acurx presentation was entitled: "Novel DNA pol IIIC Inhibitors for Gram-positive Bacterial Infections."
Three scientific posters were presented during the CLOSTPATH conference held in
The first entitled: "Ibezapolstat modulates Clostridioides difficile virulence factors in vitro" showed Ibezapolstat reduces toxin production by the C. difficile bacteria…
The second entitled: "C. difficile In Vitro Biofilm Studies of Ibezapolstat And Comparator Antibiotics" showed ibezapolstat was as effective as the currently-used anti-C. difficile antibiotics fidaxomicin, vancomycin and metronidazole in reducing reduce biofilm-embedded C. difficile…
The third entitled: "Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-C. difficile Agents" showed ibezapolstat and fidaxomicin both caused favorable proportional increases in Bacteroidetes but distinct from vancomycin and metronidazole, which caused unfavorable proportional increases in Proteobacteria.
All the presentations described above are available on our website.
Third Quarter 2023 Financial Results
Cash Position:
The Company ended the third quarter with cash totaling
R&D Expenses:
Research and development expenses for the three months ended September 30, 2023, were
G&A Expenses:
General and administrative expenses for the three months ended September 30, 2023, were
Net Loss:
The Company reported a net loss of
The Company had 13,005,128 shares outstanding as of September 30, 2023.
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: | Tuesday, November 14, 2023 |
Time: | 8:00 a.m. ET |
Toll free ( | 877-790-1503 |
Conference ID: | 13742354 |
On November 2, 2023, we reported top-line data from the Phase 2 clinical trial including the ibezapolstat clinical cure rate at end of treatment, or EOT, of
The completed multicenter, open-label single-arm segment (Phase 2a) study was 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 was 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.
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 | ||||||
September 30, | December 31, | |||||
2023 | 2022 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 7,052,329 | $ | 9,111,751 | ||
Prepaid Expenses | 105,722 | 264,955 | ||||
TOTAL ASSETS | $ | 7,158,051 | $ | 9,376,706 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 3,223,378 | $ | 2,061,685 | ||
TOTAL CURRENT LIABILITIES | 3,223,378 | 2,061,685 | ||||
TOTAL LIABILITIES | 3,223,378 | 2,061,685 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; | 13,005 | 11,628 | ||||
Additional Paid-In Capital | 52,025,931 | 45,944,478 | ||||
Accumulated Deficit | (48,104,263) | (38,641,085) | ||||
TOTAL SHAREHOLDERS' EQUITY | 3,934,673 | 7,315,021 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 7,158,051 | $ | 9,376,706 | ||
ACURX PHARMACEUTICALS, INC. | |||||||||||||
CONDENSED INTERIM STATEMENTS OF OPERATIONS | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
(unaudited) | (unaudited) | (unaudited) | (unaudited) | ||||||||||
OPERATING EXPENSES | |||||||||||||
Research and Development | $ | 1,348,985 | $ | 1,591,043 | $ | 4,100,954 | $ | 3,321,623 | |||||
General and Administrative | 1,765,996 | 1,950,551 | 5,362,224 | 5,510,642 | |||||||||
TOTAL OPERATING EXPENSES | 3,114,981 | 3,541,594 | 9,463,178 | 8,832,265 | |||||||||
NET LOSS | $ | (3,114,981) | $ | (3,541,594) | $ | (9,463,178) | $ | (8,832,265) | |||||
LOSS PER SHARE | |||||||||||||
Basic and diluted net loss per common share | $ | (0.24) | $ | (0.32) | $ | (0.77) | $ | (0.84) | |||||
Weighted average common shares outstanding | 13,005,128 | 11,148,402 | 12,282,004 | 10,551,503 | |||||||||
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SOURCE Acurx Pharmaceuticals, Inc.
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