Acurx Pharmaceuticals, Inc. Reports Full Year and Fourth Quarter Results and Provides Business Update

Core Insights - Acurx Pharmaceuticals reported significant advancements in its clinical programs and financial results for the year and fourth quarter ended December 31, 2025, highlighting the readiness to advance its antibiotic candidate, ibezapolstat, to Phase 3 trials for treating recurrent C. difficile infections (rCDI) [1][2] Financial Results - The company ended Q4 2025 with cash totaling $7.6 million, an increase from $3.7 million as of December 31, 2024 [1] - Research and development expenses for Q4 2025 were $0.3 million, down from $0.8 million in Q4 2024, primarily due to reduced manufacturing and consulting costs [1] - General and administrative expenses for Q4 2025 were $1.3 million, a decrease from $2.0 million in Q4 2024, attributed to lower compensation-related costs and professional fees [2] - The net loss for Q4 2025 was $1.6 million or $0.73 per diluted share, compared to a net loss of $2.8 million or $3.29 per diluted share in Q4 2024 [2] Clinical Developments - Acurx's clinical program for the broader CDI patient population is set to advance to Phase 3 international pivotal clinical trials, potentially benefiting from a new FDA standard that may allow for a single pivotal trial for registration [1] - The company is launching a new clinical trial program for ibezapolstat in patients with rCDI, which aims to shift treatment paradigms from two agents to one [1] - Ibezapolstat has shown a 96% clinical cure rate in a Phase 2 trial for acute CDI, with no recurrence while preserving the gut microbiome [1] Intellectual Property and Collaborations - Acurx received a new patent for its Pol IIIC inhibitors, extending protection until December 2039 [1] - The company published significant research results in Nature Communications, demonstrating the binding of ibezapolstat to its target, marking a milestone in its collaboration with Leiden University Medical Center [1] Market Position and Future Outlook - Acurx is well-positioned to commence its international Phase 3 registration program, having received positive regulatory guidance from both the FDA and EMA [2] - The company’s lead product candidate, ibezapolstat, is recognized as a Qualified Infectious Disease Product (QIDP) and has received Fast Track designation from the FDA, highlighting its potential in addressing urgent public health threats [2]