Acurx Pharmaceuticals, Inc.

Greetings and welcome to Acurex Pharmaceuticals conference call to discuss full year and fourth quarter 2025 financial results. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation. If anyone requires operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Sawa, Chief Financial Officer. Thank you. Please go ahead.

Thank you, Donna. Good morning, and welcome to our call. This morning we issued a press release providing financial results and company highlights for the year ended and fourth quarter 2025, which is available on our website at accorexpharma.com. Joining me today are Bob DeLucia, Executive Chairman of Accorex, Dr. Michael Silverman, medical director of Acorex, who will be available for questions related to our R&D activities and strategy during the Q&A period, and David Lucci, president and CEO of Acorex, who will start by providing a corporate update and outlook. Following that, I'll provide some highlights of the financials from the year and fourth quarter ended December 31, 2025, and then turn the call back over to Dave for his closing remarks. As a reminder, during today's call, we'll be making certain forward-looking statements which are based on current information, assumptions, estimates, and projections about future events that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. Investors should consider these risks and other information described in our filings with the Securities and Exchange Commission. including our annual report on Form 10-K, which we filed yesterday, Thursday, March 12, 2026. You are questioned not to place undue reliance on these forward-looking statements, and ACREX disclaims any obligation to update such statements at any time in the future. This conference call contains time-sensitive information that's accurate only as of the date of this live broadcast, today, March 13, 2026. I'll now turn the call over to Dave Vellucci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the fourth quarter and year-ended December 31, 2025, and also to hear some recent updates, which we're excited about. And we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the fourth quarter of 2025. or in some cases shortly thereafter. First, in October, the company received gross proceeds from the execution of 170,000 Series F warrants of approximately $1.4 million. Also in October, we were one of five companies to make a formal presentation at ID Week in Atlanta at the session entitled New Antimicrobials in the Pipeline. Presenting on behalf of AccuRx are Dr. Michael Silverman, our medical director, who's with us this morning, and Dr. Kevin Geary, professor and chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the Ibezopolstat clinical program. The company's presentation included an update on Ibezopolstat and its microbiome-sparing properties. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model showing the potential microbiome-sparing class effects of representative compounds from our DNA-PAL3C inhibitor preclinical pipeline. In describing the work performed at his laboratory at the University of Houston, Dr. Gary stated, initial work on a novel lead DNA-PAL3C inhibitor compounds indicate that the positive microbiome sparing results from our abezopolistat studies may be a class effect. This is an important finding because microbiome sparing likely contributed to abezopolistat's sustained efficacy in the Phase II trial for C. diff infection, where no patient cured of CDI experienced a recurrence. In our recent experiments, mice given the comparator antibiotic, linazolid, demonstrated an overabundance of uncommon and harmful gram-negative bacteria, known to contribute to recurrence of infection. Dr. Gehry further stated, these data indicate a low probability for DNA PAL3C inhibitors to increase the risk of causing a C. diff infection, mycomycin-resistant enterococcus, or other gut microbiome-related infections. In November, the company announced that the Nature Communications Scientific Journal published results from its scientific collaboration with Leiden University Medical Center, demonstrating structural biology research that reveals, for the first time, a DNA-PAL3C inhibitor, Ibezopulsat, bound to its target. The publication is entitled, A Unique Inhibitor Conformation Selectively Targets the DNA Glymerase PAL-C of Gram-Positive Priority Packages. This is an important milestone in AccurX's highly productive scientific collaboration with Leiden University Medical Center in Holland in advancing development of these new-to-nature compounds, fortifying the foundation for the rational development of this innovative class of antimicrobials against other grand positive priority pathogens. On March 9th of 2026, We issued a press release announcing that we are launching a groundbreaking Ibenzapolistat clinical trial program in patients with recurring CDI that has the potential to shift the treatment paradigm and prevention of R-CDI from two agents to one agent. When coupled with Ibenzapolistat's phase two results of being highly effective, 96% clinical cure in 26 patients in treating acute CDI, with no recurrence in patients while sparing the gut microbiome, this new trial will position Ivezopolistat as a candidate to be the first agent to demonstrate clinical success in both the treatment of CDI and the prevention of recurrent CDI. In our phase two trial, all 25 patients treated with Ivezopolistat who experienced a clinical cure were free of recurrence one month after treatment And five out of five of these patients were observed for three months after treatment, and they remained free of recurrence. During our Q&A this morning, members of our R&D team will be available to answer any questions about this new trial program. But briefly, this new clinical trial in RCDI begins with an open-label pilot trial to gain experience with Ipeza-Polstad in patients with multiple recurrent CDI with at least three episodes of CDI within the past 12 months. This will inform elements of a planned active control phase three registration trial in the RCDI indication to be implemented following favorable results from the open-label 20-patient trial. Upon subsequent successful completion of the phase three pivotal RCDI trial, And per the operative FDA procedure, the company plans to request FDA approval for treatment and prevention of R-CDI under the FDA's limited population pathway for antibacterial and antifungal drugs guidance for industry, published in 2020. Acurex's clinical program in the broader CDI patient population is ready to advance to Phase III international clinical trials. In this regard, we're very excited about the FDA's recent announcement published in the New England Journal of Medicine that a one-trial requirement will be FDA's new default standard for registration. If formalized, this would end the long-standing two-trial dogma. We look forward to FDA's further clarification and the potentially favorable implications to our clinical development programs. such as the opportunity to seek marketing approval for the broader CEI population with one pivotal clinical trial. In February 2026, we announced that the U.S. Patent and Trademark Office granted a new patent for our Call 3C inhibitors covering composition of matter and method of use. This patent extends to December 2039, subject to extension under U.S. patent rules. We continue to identify and pursue funding opportunities for our Phase III clinical trial programs for IBEZA-POLSTAT, as well as consideration of alternative financial pathways to achieve success. We have several initiatives underway to this end and will report in future updates as appropriate. As we've continually reported, IBEZA-POLSTAT clinical and non-clinical results continue to outperform and serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Additionally, Ivesipulstat has qualified infectious disease product and fast-track designations from the FDA for the treatment of C. difficile infection. as well as SME or small and medium enterprise status in Europe. We remain confident that while development of I-304 status competitive profile continues to evolve and strengthen, we will continue to navigate successfully through these challenging times in the macroeconomic environment and in our industry sector. And now back to our CFO, Rob Schaller, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025. Rob?