Release Date: November 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Acurx Pharmaceuticals Inc (ACXP, Financial) presented positive results from their phase two clinical trial for C. diff infection, indicating strong clinical efficacy.
- The company received a new patent for their treatment, Ibezapolstat, which could provide a competitive advantage until 2042.
- Acurx Pharmaceuticals Inc (ACXP) achieved CMC readiness for phase three trials, indicating regulatory progress.
- The company is exploring international regulatory pathways, starting with the European Medicines Agency, to expand market reach.
- Acurx Pharmaceuticals Inc (ACXP) is actively pursuing non-dilutive funding options, including government partnerships and territorial licenses, to support phase three trials.
Negative Points
- The company reported a decrease in cash reserves, from $7.5 million at the end of 2023 to $5.8 million by September 2024.
- Acurx Pharmaceuticals Inc (ACXP) experienced a net loss of $2.8 million for the third quarter of 2024, indicating ongoing financial challenges.
- Research and development expenses increased over the nine months ending September 2024, reflecting higher manufacturing costs.
- General and administrative expenses rose by $1.3 million over the same period, driven by increased professional and legal fees.
- The company has not yet secured a major pharmaceutical partnership, which could delay funding and progress for phase three trials.
Q & A Highlights
Q: Can you discuss more about the predictive model mentioned earlier as a potential diagnostic tool?
A: David Luci, CEO, explained that the predictive model involves proprietary measurements of stool samples that can indicate, by the third day of treatment, whether a patient is likely to experience reinfection. This model could potentially be used as a diagnostic tool to reduce the cost burden of recurrent C. difficile infections by allowing physicians to adjust treatments early.
Q: What are the details of the international regulatory filing initiatives for ibezapolstat?
A: David Luci, CEO, stated that they are starting with the European Medicines Agency, aiming for a meeting by the end of the year or early next year to set the regulatory pathway for approval. This follows the completion of FDA regulatory processes. Subsequent filings will be pursued in the UK, Canada, and Japan.
Q: What are the funding options for the phase three trials, and which do you prefer?
A: David Luci, CEO, prefers non-dilutive funding options, including government partnerships and territorial licenses. They are in discussions with several companies in Europe, Japan, and South America. The company also had a tech watch meeting with government officials to explore funding opportunities.
Q: Can you provide insights on the phase three program's timeline and design?
A: Robert Shawah, CFO, mentioned that the phase three program consists of two international registration trials with 450 patients each, randomized against oral vancomycin. The trials will have the same endpoints as the phase two B trial. The company has flexibility in conducting the trials sequentially due to regulatory exclusivity.
Q: What is the current status of the ACX-375 anthrax bioterrorism program?
A: David Luci, CEO, stated that the program is in preclinical stages, with laboratory and animal studies planned. The program has shown promising data against anthrax, a bioterrorism pathogen, and they are exploring potential government contracts for stockpiling.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
