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Acurx Pharmaceuticals: Q1 2025 Summary

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a late-stage biopharmaceutical firm, has shared its financial results and pivotal operational updates for the first quarter ended March 31, 2025. The report emphasizes significant progress in the development of its novel antibiotic therapies designed to combat challenging bacterial infections, particularly those caused by Clostridioides difficile (CDI).

Financial Highlights

In Q1 2025, Acurx successfully closed a $2.5 million direct offering to enhance its funding capabilities. The firm ended the quarter with $4.6 million in cash, an increase from $3.7 million in the previous year’s final quarter. This positive cash flow was fueled by recently raised funds totaling approximately $3.6 million from two registered direct offerings.

The company reported a net loss of $2.1 million, translating to a loss of $0.11 per diluted share, which reflects an improvement from Q1 2024’s $4.4 million loss. Notably, Acurx’s research and development expenses dropped significantly to $0.6 million from $1.6 million, thanks to reduced manufacturing costs and lower trial-related consulting expenses.

Regulatory and Clinical Development Advancements

A critical aspect of Acurx’s progress in early 2025 was the receipt of encouraging regulatory guidance from the European Medicines Agency (EMA) concerning its lead antibiotic candidate, Ibezapolstat. The EMA’s feedback is in alignment with the U.S. FDA, setting the stage for an international Phase 3 clinical trial program. This harmonization in regulatory insights positions Acurx favorably for the upcoming trials focused on treating CDI.

Furthermore, research findings published in reputable journals underscore the unique therapeutic profile of Ibezapolstat. Two significant non-clinical studies highlighted its potential superiority over existing antibiotics in addressing CDI infections while preserving beneficial gut microbiota.

Key Studies and Findings

1. In-Silico Study: Conducted by Dr. Justin McPherson of the University of Houston, this study, supported by the National Institute of Allergy and Infectious Diseases (NIAID), identified the microbiome-restorative potential of Ibezapolstat for treating CDI. The findings support the hypothesis that Ibezapolstat’s targeted action allows for the regrowth of beneficial gut microbes.

2. Head-to-Head Comparison Study: Dr. Trenton Wolfe from the University of Montana led a comparative study analyzing the impact of Ibezapolstat against other antibiotics in germ-free mice. The results revealed that Ibezapolstat induced fewer alterations in gut microbiome diversity compared to conventional treatments such as Vancomycin and Metronidazole, suggesting its potential as a selective therapy with fewer side effects.

Patent Developments

Acurx also marked significant milestones in intellectual property. The Japanese Patent Office granted a new patent for its DNA polymerase IIIC inhibitors, expiring in December 2039. This reinforces the foundation for the ongoing development of ACX-375C, another antibiotic candidate targeting MRSA and other resistant bacterial strains. In April 2025, the Indian Patent Office followed suit with a similar patent grant, further extending the intellectual property protection for these critical developments.

Looking Ahead

As Acurx Pharmaceuticals prepares to move forward with its clinical trials and product development, the company has also secured an equity line of credit with Lincoln Park Capital, providing an additional funding source of up to $12 million. This financial backing alongside its impressive Q1 performance optimistically positions Acurx for future growth.

Conclusion

Acurx Pharmaceuticals is on an exciting path as it continues to innovate in the biopharmaceutical landscape, focusing on critical infections that require advanced treatment options. With supportive regulatory feedback and strong clinical data, Acurx aims to bring its promising therapies to the forefront of antibiotic development, significantly impacting public health in the fight against antibiotic resistance.