Acurx Pharmaceuticals Announces Q2 2024 Results and Business Update

Acurx Pharmaceuticals, Inc. announced its financial and operational outcomes for the second quarter ending June 30, 2024. As a biopharmaceutical company focused on developing new antibiotics for challenging bacterial infections, Acurx shared several significant updates.

In April 2024, Acurx had a successful End-of-Phase 2 Clinical Meeting with the FDA, confirming that its lead antibiotic candidate, ibezapolstat (IBZ), is ready to progress to Phase 3 clinical trials for treating C. difficile infections. The FDA also agreed on the complete development plan necessary for filing a New Drug Application (NDA) for marketing approval. Acurx is now advancing IBZ into international Phase 3 clinical trials and plans to seek regulatory guidance for trials in the European Union, the United Kingdom, Japan, and Canada.

In the same month, Acurx participated in the European Society of Microbiology and Infectious Disease (ESCMID) scientific congress. Dr. Kevin Garey, a key figure in the company's IBZ clinical trial program, presented Phase 2 data comparing ibezapolstat with vancomycin for treating C. difficile infections. The full Phase 2 results are being prepared for submission to a prestigious scientific journal.

In May 2024, the European Medicines Agency (EMA) approved Acurx as a small to medium-sized enterprise (SME), granting the company benefits like fee reductions and additional support for seeking Marketing Authorization in Europe.

July 2024 saw further dissemination of Phase 2 results at the 17th Biennial Congress of the Anaerobe Society of the Americas. Dr. Taryn A. Eubank presented on the clinical efficacy of ibezapolstat in C. difficile infections. Additionally, the United States Patent and Trademark Office (USPTO) granted Acurx a new patent for ibezapolstat, covering its use in treating C. difficile infection, reducing recurrence, and improving gut microbiome health. This patent will expire in June 2042.

In August 2024, Acurx submitted a request to the FDA for a meeting to review manufacturing processes and specifications, a customary step before commencing Phase 3 clinical trials. This follows their successful End-of-Phase 2 clinical meeting with the FDA, which confirmed readiness for Phase 3 trials.

Acurx plans to continue presenting Phase 2 results through either oral presentations or scientific posters at several upcoming conferences. These include the World Antimicrobial Resistance conference in Philadelphia and the 8th International C. difficile Symposium in Bled, Slovenia, both in September 2024. In October 2024, they will present at the annual meeting of the Infectious Diseases Society of America (ID Week) in Los Angeles. The company's international regulatory initiatives will persist throughout the second half of 2024.

Financially, Acurx ended the second quarter with $6.4 million in cash, down from $7.5 million on December 31, 2023. During this quarter, the company raised approximately $0.3 million through the sale of additional shares. Research and development expenses for this period were $1.8 million, up from $1.7 million in the same quarter of 2023, mainly due to increased manufacturing costs. General and administrative expenses also rose to $2.3 million from $1.7 million, driven by higher professional fees and share-based compensation costs. The net loss for the three months ended June 30, 2024, was $4.1 million, equating to $0.26 per diluted share, compared to a net loss of $3.4 million or $0.28 per diluted share for the same period in 2023. For the first half of 2024, the net loss amounted to $8.5 million or $0.54 per share, compared to $6.3 million or $0.53 per share for the same period in 2023. As of June 30, 2024, Acurx had 15,996,168 shares outstanding.

Ibezapolstat is Acurx's leading antibiotic candidate, set to enter international Phase 3 clinical trials for treating C. difficile Infection (CDI). It is an orally administered Gram-Positive Selective Spectrum (GPSS®) antibacterial and the first DNA polymerase IIIC inhibitor developed by Acurx. Ibezapolstat's unique activity spectrum appears to contribute to maintaining a healthy gut microbiome. The FDA has designated ibezapolstat as a Qualified Infectious Disease Product (QIDP) and granted it "Fast Track" status for treating CDI. The CDC has recognized C. difficile as an urgent threat, underscoring the need for new antibiotics like ibezapolstat.

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