Acurx Pharmaceuticals Announces Q1 2024 Results and Business Update

Acurx Pharmaceuticals, a clinical-stage biopharmaceutical company specializing in innovative antibiotics for challenging bacterial infections, disclosed its financial and operational results for the first quarter ending March 31, 2024. The company has made significant strides in its ongoing clinical trials and regulatory processes, particularly with its lead antibiotic candidate, ibezapolstat, designed to combat Clostridioides difficile Infection (CDI).

On January 17, 2024, Acurx announced promising microbiology and microbiome data from the Phase 2b clinical trial, where ibezapolstat demonstrated superior performance compared to vancomycin. Ibezapolstat achieved a 94% eradication rate of fecal C. difficile by Day 3 of treatment, compared to a 71% eradication rate for vancomycin. Furthermore, ibezapolstat was able to preserve and promote the regrowth of crucial gut bacteria, which vancomycin did not achieve. These findings suggest that ibezapolstat could significantly reduce CDI recurrence.

The company recently conducted an End of Phase 2 Meeting with the FDA in April 2024, where it reached agreements on key elements of the Phase 3 clinical trial and regulatory pathway for filing a new drug application (NDA) in the U.S. Additionally, the European Medicines Agency (EMA) approved Acurx’s application for designation as a small to medium-sized enterprise (SME), which provides benefits like fee reductions and regulatory support in Europe.

In April 2024, Acurx participated in the European Society of Microbiology and Infectious Disease (ESCMID) scientific congress, where Dr. Kevin Garey presented the Phase 2 data of ibezapolstat compared to vancomycin. The presentation, which included further clinical and microbiological analyses, highlighted the potential of ibezapolstat as a leading treatment for CDI.

Throughout the remainder of the year, Acurx plans to present additional Phase 2 data through oral presentations and scientific posters at various prestigious 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 Infectious Diseases Society of America’s annual meeting (IDWeek).

Financially, Acurx reported a cash position of $8.9 million at the end of the first quarter, an increase from $7.5 million at the end of 2023. The company raised approximately $4.4 million by selling over a million shares under its ATM financing program. Research and development expenses rose to $1.6 million, primarily due to increased manufacturing costs, while general and administrative expenses increased to $2.8 million, driven by higher professional fees and share-based compensation. The net loss for the first quarter of 2024 was $4.4 million, translating to $0.28 per diluted share, compared to a net loss of $2.9 million or $0.25 per diluted share in the same period of the previous year. As of March 31, 2024, the company had 15,757,102 shares outstanding.

Looking ahead, Acurx remains focused on advancing ibezapolstat into international Phase 3 clinical trials. Ibezapolstat, an orally administered antibiotic, is the front-runner in Acurx’s pipeline, designed as a Gram-Positive Selective Spectrum (GPSS®) antibacterial targeting DNA polymerase IIIC in Gram-positive bacteria. This novel mechanism aims to maintain a healthy gut microbiome while effectively treating CDI.

The FDA had previously designated ibezapolstat as a Qualified Infectious Disease Product (QIDP) and granted it "Fast Track" status, recognizing the urgent need for new CDI treatments. Acurx continues to build on its innovative research and development efforts, targeting various Gram-positive bacteria, including MRSA, VRE, and DRSP, to address the growing challenge of antibiotic resistance.

Acurx Pharmaceuticals remains committed to developing groundbreaking antibiotics to tackle some of the most difficult-to-treat bacterial infections and is poised for significant progress in its clinical and regulatory endeavors in the year ahead.