Acurx Pharmaceuticals (ACXP) Q2 2025 Earnings Call August 12, 2025 08:00 AM ET Speaker0Greetings, and welcome to the Accurate Pharmaceuticals to discuss Second Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Robert Shawwal, Chief Financial Officer.Please go ahead.Speaker1Thank you, Stacy ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash totaling $4.6 million, an increase from $3.7 million as of December 31, 2024 [14] - The net loss for Q1 2025 was $2.1 million or $0.11 per diluted share, compared to a net loss of $4.4 million or $0.28 per diluted share for Q1 2024 [16] Business Line Data and Key Metrics Changes - Research and development expenses for Q1 2025 were $600,000, down from $1.6 million in Q1 2024, primarily due to a decrease in manufacturing and consulting costs [15] - General and administrative expenses decreased to $1.6 million in Q1 2025 from $2.8 million in Q1 2024, attributed to lower professional fees and share-based compensation costs [15] Market Data and Key Metrics Changes - The company raised approximately $3.6 million in gross proceeds through two registered direct offerings during the quarter [15] - The company anticipates that the anti-recurrence effect of ibezafolstat could reduce the need for expensive microbiome therapeutic agents for C. difficile infection [6] Company Strategy and Development Direction - The company is well-positioned to commence its international Phase III registration program following positive regulatory guidance from both the European Medicines Agency and the FDA [5] - The company is exploring microbiome-related endpoints in its Phase III trial to reinforce differentiation in the CDI space [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position relative to other biotech firms, despite the challenging macroeconomic environment [13] - The company is actively pursuing funding opportunities for its Phase III clinical trial program and has several initiatives underway [11] Other Important Information - The company closed an equity line of credit with Lincoln Park Capital for up to $12 million [9] - A publication summarizing positive Phase II results for ibezafolstat is expected to be published in the Lancet Micro [9] Q&A Session Summary Question: Plans to explore recent publication on microbiome preserving effects - Management confirmed that preservation and restoration of the microbiome is a secondary endpoint in the Phase III program design and is actively being explored [20] Question: Trajectory of R&D and G&A costs through 2025 - Management expects both G&A and R&D costs to continue decreasing until the Phase III program starts, but did not provide a specific start date due to pending funding [26][27] Question: Updates on past due act and funding opportunities - Management mentioned ongoing discussions with lobby groups and various funding opportunities, including applications to ARPA-H and interest from European FDA-type groups [29][30] Question: Comments on ultra-rare path for approvals - Management indicated that the possibility of following an ultra-rare path for antibiotic approvals is being discussed internally, although it would be a first for antibiotics [32]