Acurx Pharmaceuticals, Inc. Reports First Quarter 2024 Results and Provides Business Update
Acurx Pharmaceuticals (NASDAQ: ACXP) announced its Q1 2024 financial and operational results, highlighting significant progress in its clinical trials and business operations.
Key achievements include positive data from the Phase 2b trial of ibezapolstat, which showed superior results over vancomycin for treating CDI, with a 94% eradication rate of C. difficile by Day 3. The FDA has agreed on the Phase 3 program and NDA filing pathway. The European Medicines Agency designated Acurx as an SME, providing fee reductions and support.
Financially, Acurx ended Q1 2024 with $8.9 million in cash, up from $7.5 million at the end of 2023. The company reported a net loss of $4.4 million, driven by increased R&D and G&A expenses. 1,121,793 shares were sold under ATM financing, raising $4.4 million.
Further data and presentations are anticipated throughout 2024 at several scientific conferences.
- Positive Phase 2b data for ibezapolstat showing 94% eradication of C. difficile by Day 3.
- Agreement with FDA on Phase 3 program and NDA filing pathway.
- Designation as an SME by the European Medicines Agency, providing fee reductions and support.
- Cash position increased to $8.9 million from $7.5 million as of December 31, 2023.
- Raised $4.4 million through ATM financing program.
- Net loss of $4.4 million for Q1 2024, compared to a $2.9 million loss in Q1 2023.
- Increased R&D expenses to $1.6 million, up from $1.0 million in Q1 2023 due to higher manufacturing costs.
- G&A expenses rose to $2.8 million from $1.9 million in Q1 2023, primarily due to increased professional fees and share-based compensation.
- Dilution of shares with 1,121,793 additional shares sold under ATM financing.
Insights
The financial results for Acurx Pharmaceuticals show a significant increase in both research & development (R&D) and general & administrative (G&A) expenses.
R&D expenses rose from
G&A expenses also saw a rise from
Despite the increased expenses, the cash position improved from
However, the net loss widened to
Overall, while the increased costs are expected in clinical-stage companies, the improved cash position is a positive signal. The key will be the success of Phase 3 trials, which can significantly impact long-term profitability.
The clinical data for Acurx’s drug, ibezapolstat, is promising. In the Phase 2b trial, ibezapolstat had a 94% eradication rate of C. difficile by Day 3, compared to 71% for vancomycin. This is a substantial improvement and indicates superior efficacy. Furthermore, ibezapolstat preserved beneficial gut bacteria, which is not observed with vancomycin. This preservation is important as it could potentially reduce recurrence rates of infections, a significant advantage.
The recent FDA End of Phase 2 meeting agreement on Phase 3 program elements and NDA filing pathway is a important step forward. This approval suggests that the FDA finds the preliminary data compelling enough to proceed to the next phase, reducing regulatory risks.
Receiving SME designation from the European Medicines Agency (EMA) also benefits Acurx by reducing fees and providing support, potentially facilitating a smoother path to European market entry.
In summary, the clinical results and regulatory progress are strong indicators of potential future success, but investors should be aware that Phase 3 trials are still pending, which involves both opportunity and risk.
Acurx is positioning itself favorably in the antibiotic market, particularly in addressing difficult-to-treat bacterial infections. The Phase 2b results showing ibezapolstat's superiority over vancomycin position the drug as a potential market leader if approved. The ability to preserve gut microbiota is a key differentiator that could attract significant interest from healthcare providers prioritizing long-term patient health.
Presenting at prominent scientific conferences like ESCMID and others throughout the year is a strategic move to build credibility and visibility within the medical community. This could drive early interest and acceptance among prescribers, which is essential for market penetration upon approval.
However, the market entry is contingent on successful Phase 3 outcomes and subsequent regulatory approvals, which means the next couple of years will be crucial. Investors need to assess the company's ability to manage these processes efficiently.
Overall, Acurx's strategic steps in clinical development and market preparation are well-aligned, but the inherent risks of drug development remain.
Highlights of the first quarter ended March 31, 2024, or in some cases shortly thereafter, include:
- On January 17, 2024, we announced positive comparative microbiology and microbiome data for ibezapolstat in CDI patients from the Phase 2b clinical trial segment. Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (
94% ), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71% ). - Additional data from this Phase 2b clinical trial showed ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI.
- Additional data from exploratory endpoints will provide further favorable separation between these two therapeutic options in our Phase 3 clinical trial program and ultimately in the marketplace, if approved.
- An End of Phase 2 Meeting was recently conducted with FDA in April 2024. At the FDA meeting, we reached agreement on key elements of our Phase 3 program and readiness to proceed to Phase 3. We also reached agreement on the regulatory pathway for a new drug application (or NDA) filing for marketing approval in the
U.S. - We announced that the European Medicines Agency (or EMA) approved our application to be designated as a small to medium sized enterprise (or SME) in
Europe which provides for certain benefits including fee reductions and other support from the EMA for seeking a Marketing Authorization forEurope . - We attended the European Society of Microbiology and Infectious Disease (or ESCMID) scientific congress held in April 2024 where Dr. Kevin Garey, Professor and Chair, University of
Houston College of Pharmacy, and the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member gave an oral presentation of our Phase 2 data entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection." The presentation included additional analyses of clinical and microbiological data and is available on our website at www.acurxpharma.com. - Throughout the rest of this year, we will continue to roll out our Phase 2 results in either oral presentations or scientific posters (in some cases both), which by the way, will include results from new analyses as data become available, at various prominent scientific conferences including:
- The Houston Cdiff and Microbiome conference;
- The Anaerobe Society of America annual conference;
- The World Antimicrobial Resistance conference;
- The International Cdifficile Symposium; and
- The annual meeting of the Infectious Diseases Society of America (or IDWeek).
First Quarter of 2024 Financial Results
- Cash Position:
The Company ended the quarter with cash totaling$8.9 million $7.5 million $4.4 million - R&D Expenses:
Research and development expenses for the three months ended March 31, 2024 were$1.6 million $1.0 million - G&A Expenses:
General and administrative expenses for the three months ended March 31, 2024 were$2.8 million $1.9 million $0.7 million $0.2 million - Net Income/Loss:
The Company reported a net loss of$4.4 million $0.28 $2.9 million $0.25
The Company had 15,757,102 shares outstanding as of March 31, 2024.
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: | Wednesday, May 15, 2024 | |
Time: | 8:00 a.m. ET | |
Toll free ( | 877-790-1503 | |
Conference ID: | 13746308 | |
About Ibezapolstat
Ibezapolstat is the Company's lead antibiotic candidate advancing to international Phase 3 clinical trials to treat patients with C. difficile Infection (CDI). Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.
In June 2018, ibezapolstat was designated by the
About Acurx Pharmaceuticals, Inc.
Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes 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, 2023, 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 | ||||||
March 31, | December 31, | |||||
2024 | 2023 | |||||
(unaudited) | (Note 2) | |||||
ASSETS | ||||||
CURRENT ASSETS | ||||||
Cash | $ | 8,920,926 | $ | 7,474,188 | ||
Other Receivable | — | 129,159 | ||||
Prepaid Expenses | 187,908 | 105,776 | ||||
TOTAL ASSETS | $ | 9,108,834 | $ | 7,709,123 | ||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||
CURRENT LIABILITIES | ||||||
Accounts Payable and Accrued Expenses | $ | 3,110,242 | $ | 3,042,438 | ||
TOTAL CURRENT LIABILITIES | 3,110,242 | 3,042,438 | ||||
TOTAL LIABILITIES | 3,110,242 | 3,042,438 | ||||
COMMITMENTS AND CONTINGENCIES | ||||||
SHAREHOLDERS' EQUITY | ||||||
Common Stock; | 15,757 | 14,468 | ||||
Additional Paid-In Capital | 63,579,577 | 57,871,070 | ||||
Accumulated Deficit | (57,596,742) | (53,218,853) | ||||
TOTAL SHAREHOLDERS' EQUITY | 5,998,592 | 4,666,685 | ||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 9,108,834 | $ | 7,709,123 | ||
ACURX PHARMACEUTICALS, INC. | ||||||||
CONDENSED INTERIM STATEMENTS OF OPERATIONS | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2024 | 2023 | |||||||
(unaudited) | (unaudited) | |||||||
OPERATING EXPENSES | ||||||||
Research and Development | $ | 1,555,011 | $ | 1,015,583 | ||||
General and Administrative | 2,822,878 | 1,887,374 | ||||||
TOTAL OPERATING EXPENSES | 4,377,889 | 2,902,957 | ||||||
NET LOSS | $ | (4,377,889) | $ | (2,902,957) | ||||
LOSS PER SHARE | ||||||||
Basic and diluted net loss per common share | $ | (0.28) | $ | (0.25) | ||||
Weighted average common shares outstanding, basic and diluted | 15,472,507 | 11,639,395 | ||||||
View original content:https://www.prnewswire.com/news-releases/acurx-pharmaceuticals-inc-reports-first-quarter-2024-results-and-provides-business-update-302145358.html
SOURCE Acurx Pharmaceuticals, Inc.
FAQ
What were Acurx Pharmaceuticals' Q1 2024 financial results?
How did ibezapolstat perform in the Phase 2b trial for CDI?
What is the significance of Acurx's designation as an SME by the EMA?
What agreements were made with the FDA regarding Acurx's Phase 3 program?
How much did Acurx Pharmaceuticals raise through ATM financing in Q1 2024?
What were Acurx Pharmaceuticals' R&D expenses for Q1 2024?
What were the reasons for the increased G&A expenses in Q1 2024?
