ACXP Overview

New to The Street Milestone: The business television platform "New to The Street" celebrated its 700th episode, airing on Bloomberg Television, highlighting its growth in various media channels and showcasing innovative companies in technology, finance, healthcare, and consumer culture.

Featured Companies: The episode featured several companies, including Lionscrest Advisors, DataVault AI, Pudgy Penguins, Peer To Peer Network, and Acurx Pharmaceuticals, each recognized for their contributions to their respective industries.

Lionscrest Advisors: This global advisory firm specializes in capital markets, M&A, and corporate finance, providing strategic insights to clients navigating complex financial landscapes.

DataVault AI and Others: DataVault AI focuses on AI-driven business intelligence and data management, while Pudgy Penguins has expanded into mainstream media and retail, and Acurx Pharmaceuticals is developing new antibiotics for challenging bacterial infections.

Financial Compliance and Stock Split: Acurx Pharmaceuticals executed a 1-for-20 reverse stock split, regaining compliance with Nasdaq's minimum bid price and stockholders' equity requirements, ensuring continued listing on the Nasdaq Stock Market.

Patent Developments: The company received a new patent from the Australian Patent Office for its DNA polymerase IIIC inhibitors, adding to its existing patents in the U.S. and other countries, which cover treatments for infections caused by Gram-positive bacteria.

Research and Development Updates: Acurx presented at IDWeek 2025, showcasing new data on its lead antibiotic candidate, ibezapolstat, which is preparing for Phase 3 clinical trials to treat C. difficile infections, and published significant findings in Nature Communications regarding its mechanism of action.

Financial Performance: Acurx reported a net loss of $2.0 million for Q3 2025, an improvement from the previous year's loss, with cash reserves increasing to $5.9 million, supported by recent fundraising efforts through warrant exercises and an equity line of credit.

Introduction of New Antibiotics: Acurx Pharmaceuticals is developing a new class of antibiotics, DNA polymerase IIIC inhibitors, targeting Gram-positive bacteria such as C. difficile, MRSA, and VRE, with their lead candidate, ibezapolstat, showing promising Phase 2 results for treating C. difficile infections.

Clinical Trial Success: Ibezapolstat demonstrated a 96% clinical cure rate in Phase 2 trials, with no recurrence of infection, and is now ready for Phase 3 trials in the U.S. and EU, supported by positive regulatory feedback from the FDA and EMA.

Research Collaboration: Acurx's collaboration with Leiden University Medical Center has provided structural insights into ibezapolstat's mechanism of action, aiding the development of new antibiotics against multi-drug-resistant pathogens.

Microbiome Preservation: Ibezapolstat treatment appears to maintain a healthy gut microbiome, showing favorable changes in bile acid metabolism that may reduce the likelihood of C. difficile recurrence compared to traditional treatments like vancomycin.

Ibezapolstat's Unique Properties: Acurx Pharmaceuticals' ibezapolstat (IBZ) shows selective antibacterial activity in the gut, preserving beneficial bacteria and contributing to its effectiveness against C. difficile infection (CDI) without increasing the risk of recurrence.

Clinical Trial Success: The Phase 2 clinical trials demonstrated a 96% clinical cure rate for ibezapolstat in CDI patients, with 100% of those cured remaining free of recurrence, indicating its potential superiority over traditional treatments like vancomycin.

Microbiome-Sparing Effects: New data suggest that ibezapolstat may have a microbiome-sparing class effect, which is crucial for maintaining gut health and preventing CDI recurrence, a significant concern with existing antibiotics.

Regulatory Progress and Future Trials: Ibezapolstat has received FDA QIDP and Fast-Track Designations, and Acurx is preparing to initiate international Phase 3 trials, aiming to establish its efficacy and safety for broader use against Gram-positive bacterial infections.

Upcoming Financial Results Call: Acurx Pharmaceuticals will discuss its Q3 2025 financial results on November 12, 2025, at 8:00 am ET, hosted by CEO David P. Luci and CFO Robert G. Shawah.

Ibezapolstat Development: The company's lead antibiotic candidate, ibezapolstat, is preparing for international Phase 3 clinical trials to treat C. difficile infections, having received positive regulatory guidance from the EMA.

Regulatory Designations: Ibezapolstat has been designated as a Qualified Infectious Disease Product (QIDP) and received "Fast Track" designation from the FDA, highlighting its potential in addressing urgent bacterial threats.

Company Focus: Acurx Pharmaceuticals specializes in developing a new class of antibiotics targeting difficult-to-treat bacterial infections, particularly those caused by Gram-positive bacteria.

Patent Announcement: Acurx Pharmaceuticals has been granted a new patent in Australia for DNA Polymerase IIIC Inhibitors, adding to its portfolio of patents across multiple countries to protect its antimicrobial technologies.

Product Development: The company is advancing its lead product candidate, ibezapolstat, for treating C. difficile Infection, and is also developing new compounds targeting various serious bacterial infections, including those caused by multidrug-resistant pathogens.