Core Viewpoint - Acurx Pharmaceuticals has entered into a warrant inducement agreement to facilitate the exercise of existing warrants at a significantly reduced price, generating approximately $2.67 million in gross proceeds for the company [1][2]. Group 1: Warrant Inducement Agreement - The company has a warrant inducement agreement with a holder of existing warrants to purchase up to 4,445,435 shares at exercise prices between $3.25 and $3.26 per share, allowing the holder to exercise these warrants at a reduced price of $0.675 per share [1]. - In exchange for exercising the existing warrants, investors will receive 6,223,609 G-1 warrants and 2,667,261 G-2 warrants, totaling 8,890,870 new warrants [1]. - The G-1 and G-2 warrants are both exercisable at $0.425 per share and will expire five years from the issuance date [1]. Group 2: Use of Proceeds - The net proceeds from the warrant exercise are intended for working capital and general corporate purposes [2]. Group 3: Regulatory and Clinical Development - Ibezapolstat, the company's lead antibiotic candidate, is advancing to international Phase 3 clinical trials for treating C. difficile Infection (CDI) and has received FDA designations that may expedite its development [5]. - The antibiotic is part of a new class of drugs targeting Gram-positive bacteria, which includes significant pathogens like MRSA and VRE [6].

Financial Results - The company ended Q1 2025 with cash totaling $4.6 million, an increase from $3.7 million as of December 31, 2024 [1] - Research and development expenses for Q1 2025 were $0.6 million, down from $1.6 million in Q1 2024, primarily due to decreased manufacturing and consulting costs [3] - General and administrative expenses for Q1 2025 were $1.6 million, a decrease from $2.8 million in Q1 2024, attributed to lower professional fees and share-based compensation costs [4] - The company reported a net loss of $2.1 million or $0.11 per diluted share for Q1 2025, compared to a net loss of $4.4 million or $0.28 per diluted share for Q1 2024 [5] Operational Highlights - The company received positive regulatory guidance from the European Medicines Agency (EMA) for the ibezapolstat Phase 3 clinical trial program, aligning with FDA feedback [2] - New publications in the Journal of Antimicrobial Agents and Chemotherapeutics highlighted non-clinical studies that differentiate ibezapolstat from other antibiotics for treating C. difficile infection [2] - A new patent for DNA polymerase IIIC inhibitors was granted by the Japanese Patent Office, expiring in December 2039, supporting the development of ACX-375C [2] - The company closed a registered direct offering and private placement, raising gross proceeds of $1.1 million in March 2025 [2] Product Development - Ibezapolstat is the lead antibiotic candidate advancing to international Phase 3 clinical trials for treating C. difficile infection [7] - Ibezapolstat is a novel, orally administered antibiotic with a Gram-Positive Selective Spectrum (GPSS®) that spares beneficial gut microbiota while targeting C. difficile [7] - The CDC has designated C. difficile as an urgent threat, emphasizing the need for new antibiotics [7] - The company’s R&D pipeline includes antibiotic candidates targeting Gram-positive bacteria, including MRSA and VRE [8]

Financial Data and Key Metrics Changes - The company ended 2024 with cash totaling $3.7 million, down from $7.5 million as of December 31, 2023 [25] - Research and development expenses for Q4 2024 were $0.8 million, a decrease of $1.1 million from $1.9 million in Q4 2023 [25][26] - General and administrative expenses for Q4 2024 were $2 million, down from $3.2 million in Q4 2023, primarily due to decreases in professional fees and share-based compensation [27] - The company reported a net loss of $2.8 million or $0.16 per diluted share for Q4 2024, compared to a net loss of $5.1 million or $0.37 per diluted share for Q4 2023 [28] Business Line Data and Key Metrics Changes - The company is advancing its lead antibiotic candidate, ibezapolstat (IBZ), into international Phase 3 clinical trials for the treatment of C. difficile infection [8] - In Phase 2 trials, ibezapolstat demonstrated a clinical cure rate of 96%, with 100% of patients remaining cured one month after treatment [9][10] Market Data and Key Metrics Changes - The company raised a total of $6.6 million in gross proceeds under its ATM financing program for the year ended December 31, 2024 [25] - The FDA has granted ibezapolstat QIDP and Fast Track designations for the treatment of C. difficile infection, indicating a favorable regulatory environment [22] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase 3 registration program following positive regulatory guidance from both the EMA and FDA [13] - The company aims to differentiate ibezapolstat from other antibiotics by demonstrating its microbiome-restorative potential and lower recurrence rates [14][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for partnerships and funding opportunities to support the Phase 3 trial, emphasizing the importance of government and quasi-government partnerships [42][43] - The company believes that ibezapolstat could significantly reduce the annual cost burden of C. difficile infections in the US, which is estimated at $5 billion [23] Other Important Information - The Japanese Patent Office granted a new patent for the company's DNA polymerase IIIC inhibitors, expiring in December 2039 [19] - The company closed a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million [20] Q&A Session Summary Question: Differences and similarities between FDA and EMA for Phase 3 program - Management confirmed that the protocols are identical and there is complete agreement from both agencies [35] Question: Geographic enrollment for Phase 3 program - The plan is to have 150 clinical trial sites, with half in Europe and the other half in the US, Canada, and South America [37] Question: Upcoming data releases for ibezapolstat - A full set of Phase 2 data is expected to be published in a prestigious scientific journal within the next 30 days [40] Question: Funding options for development of ACX-375C - Management is exploring partnerships and grants from government bodies as primary funding sources [42] Question: Partnership environment and timeline for Phase 3 trials - Management noted challenges in securing partnerships but remains optimistic about potential collaborations in 2025 [56] Question: Timeline for top-line data from Phase 3 trials - It is expected to take two years from the first patient enrolled to obtain top-line data [62] Question: Status of the ATM program and NASDAQ listing - The ATM program was suspended but can be reactivated, and management is confident in maintaining the NASDAQ listing [70][72]