Acurx Pharmaceuticals Llc ((ACXP)) has held its Q4 earnings call. Read on for the main highlights of the call.
Acurx Pharmaceuticals recently held an earnings call that conveyed a generally positive sentiment, underscored by significant clinical advancements and regulatory support for its lead candidate, ibezapolstat. Despite facing financial hurdles and the necessity for additional funding, the company has made strides in reducing its losses and securing a new patent. The management expressed confidence in addressing potential NASDAQ listing concerns, contributing to an optimistic outlook.
Advancement to Phase 3 Trials
Acurx Pharmaceuticals is on the brink of a major milestone as it prepares to advance ibezapolstat into international Phase 3 clinical trials for the treatment of C. difficile infection. This progression holds the promise of regulatory approval in both the US and EU, marking a significant step forward in the company’s clinical development pipeline.
Positive Phase 2b Clinical Results
The Phase 2b clinical trials of ibezapolstat yielded impressive results, achieving a 100% clinical cure rate with no recurrence of infection in patients monitored for three months post-treatment. These outcomes bolster the drug’s potential efficacy and pave the way for its advancement into the next phase of trials.
Regulatory Support from FDA and EMA
Acurx has received encouraging regulatory guidance from both the FDA and EMA, which have aligned on the clinical, non-clinical, and manufacturing aspects of the Phase 3 program. This regulatory support is crucial for the company as it moves forward with its clinical trials.
New Patent in Japan
The company has been granted a new patent in Japan for DNA polymerase IIIC inhibitors, which supports the ongoing development of ACX-375C. This patent opens up potential applications against MRSA, VRE, and Anthrax, expanding the company’s intellectual property portfolio.
Financial Improvements
Acurx reported a decrease in net loss to $2.8 million in Q4 2024 from $5.1 million in Q4 2023. This improvement is attributed to significant reductions in research and development and administrative expenses, reflecting the company’s efforts to streamline operations.
Decreased Cash Position
The company’s cash reserves have decreased from $7.5 million at the end of 2023 to $3.7 million at the end of 2024, highlighting ongoing financial challenges. This decrease underscores the need for additional funding to support future clinical endeavors.
Dependence on External Funding
The commencement of Phase 3 trials is contingent upon securing additional funding. Acurx is actively seeking partnerships and government grants to support its clinical programs, emphasizing the importance of external financial support for its continued progress.
NASDAQ Listing Risk
Concerns have been raised regarding the company’s ability to maintain its NASDAQ listing due to the current share price. However, management remains confident in their ability to address this issue, suggesting strategic measures are in place to mitigate this risk.
Forward-Looking Guidance
Looking ahead, Acurx Pharmaceuticals has outlined its fiscal year 2024 performance and future plans. The company reported a net loss of $2.8 million for the fourth quarter of 2024, an improvement from the $5.1 million loss in the same period of 2023. For the full year, the net loss was $14.1 million, slightly better than the $14.6 million loss in 2023. The company is set to advance ibezapolstat into international Phase 3 trials, with regulatory alignment from both the FDA and EMA. Recent funding efforts, including a $2.5 million direct offering in January 2025 and an additional $1.1 million in March 2025, underscore the company’s commitment to advancing its clinical programs.
In summary, Acurx Pharmaceuticals’ earnings call reflects a positive outlook, driven by clinical advancements and regulatory support for ibezapolstat. Despite financial challenges, the company has made notable progress in reducing losses and securing new patents. With strategic efforts to address NASDAQ listing concerns and secure additional funding, Acurx is poised for continued growth and development in the pharmaceutical landscape.