Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash totaling 7.5 million as of December 31, 2023 [25] - The net loss for Q3 2024 was 0.17 per diluted share, compared to a net loss of 0.24 per diluted share for Q3 2023 [30] - For the nine months ended September 30, 2024, the net loss was 0.71 per share, compared to a net loss of 0.77 per share for the same period in 2023 [30] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2024 were 1.3 million in Q3 2023 [26] - General and administrative expenses for Q3 2024 were 1.8 million in Q3 2023 [28] - For the nine months ended September 30, 2024, general and administrative expenses increased to 5.4 million in the same period in 2023 [29] Market Data and Key Metrics Changes - The company has received FDA QIDP and Fast Track designation for ibezapolstat, which is aimed at treating C. difficile infection, categorized as an urgent threat by the U.S. CDC [23] - The potential economic impact of ibezapolstat, if approved, could reduce the annual U.S. cost burden for C. difficile infection by approximately 2.8 billion attributed to recurrent infections [24] Company Strategy and Development Direction - The company is focusing on advancing ibezapolstat through Phase III clinical trials, with a roadmap for international regulatory filings starting in Europe [12][35] - Acurx is prioritizing the oral form of its gram-positive selective spectrum program for acute bacterial skin infections, including MRSA, to expedite lead product selection [14] - The company is exploring non-dilutive funding options, including partnerships and government grants, to support the Phase III trials [37][53] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing clinical results of ibezapolstat, which continue to outperform in treating C. difficile infections [22] - The company is confident that the best is yet to come, given the momentum in clinical trials and regulatory processes [24] - Management highlighted the importance of the predictive model for recurrent infections, which could lead to a new diagnostic tool [32] Other Important Information - Acurx received a new patent for ibezapolstat, which will expire in June 2042, providing a competitive advantage in the market [8] - The company is also developing ACX-375 for bioterrorism applications, specifically targeting Anthrax, with promising preliminary results [19] Q&A Session Summary Question: Can you discuss more about the predicted model that you discussed earlier on the call, a potential diagnostic tool? - Management explained that certain measurements from stool samples could predict reinfection risk by the end of the third day of treatment, which could help reduce costs associated with recurrent infections [32][34] Question: Can you discuss more details about the international regulatory filing initiatives ongoing this quarter? - The company is starting the regulatory process in Europe with the European Medicines Agency, aiming for a meeting to set the regulatory pathway for international Phase III trials [35][36] Question: Can you outline what are some top options that you will consider likely to be able to fund the pivotal trials? - Management prefers non-dilutive funding options, including partnerships and government grants, to support the Phase III trials [37][53] Question: What are the earliest potential sites for the first Phase III trial and any proposed study design or data readout timelines? - The design includes two international Phase III trials with 150 sites and 450 patients each, randomized against oral vancomycin [41] Question: Where are you currently in the development of the Anthrax bioterrorism program? - The program is in preclinical stages, with laboratory and animal studies planned to further develop the findings [44] Question: What are other future clinical development plans for the GPSS program targeting MRSA? - The initial focus will be on MRSA infections, followed by VRE and DRSP infections [46] Question: Can you talk a little more about the possibility of partnership in the near future? - Management indicated that they are exploring various partnership opportunities that would not dilute shareholder value, including territorial licenses and co-development agreements [50][52]
Acurx Pharmaceuticals(ACXP) - 2024 Q3 - Earnings Call Transcript