In This Article:
Release Date: March 18, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Acurx Pharmaceuticals Inc (NASDAQ:ACXP) is advancing its lead antibiotic candidate, Ibezapolstat, into international phase 3 clinical trials for C. difficile infection.
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The company reported a high clinical cure rate of 96% in phase 2 trials, with 100% of Ibezapolstat-treated patients remaining cured one month after treatment.
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Acurx Pharmaceuticals Inc (NASDAQ:ACXP) received positive regulatory guidance from both the FDA and the European Medicines Agency, aligning their phase 3 clinical trial program.
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The company closed a $2.5 million registered direct offering and a $1.1 million private placement, strengthening its financial position.
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A new patent was granted by the Japanese patent office for DNA gyrase inhibitors, extending intellectual property protection until December 2039.
Negative Points
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Acurx Pharmaceuticals Inc (NASDAQ:ACXP) ended the year with a reduced cash position of $3.7 million, down from $7.5 million the previous year.
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The company reported a net loss of $2.8 million for the fourth quarter of 2024, indicating ongoing financial challenges.
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Research and development expenses decreased, primarily due to reduced consulting costs, but manufacturing costs increased.
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General and administrative expenses increased slightly for the year, driven by higher professional and legal fees.
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The company faces challenges in securing partnerships and funding, with market turmoil impacting potential collaborations.
Q & A Highlights
Q: Can you discuss the notable differences and similarities between what the FDA and the EMA are looking for in the phase 3 program? A: Dave Luci, President and CEO: The protocols are identical. We waited to approach the European Medicines Agency until we had cleared all aspects with the FDA. There is complete agreement in all regards for both agencies.
Q: How do you envision the phase 3 program will enroll patients geographically? A: Dave Luci, President and CEO: We plan to start with 150 clinical trial sites, with half in Europe and the other half in the US, Canada, and South America. Approximately 30% of the sites will be in the US, compared to 50% in Europe.
Q: When should we expect more data after the microbiome study published last month? A: Dave Luci, President and CEO: We expect a prestigious scientific publication to include our full set of phase 2 data within the next 30 days. More data will continue to emerge from ongoing studies.