Acurx Pharmaceuticals, Inc.

and welcome to the Accurate Pharmaceuticals first quarter 2025 financial results and business update. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press bar zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the call over to your host, Rob Schaller, Chief Financial Officer of Accurate Pharmaceuticals. Thank you. You may begin.

Thank you, Melissa. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first quarter of 2025, which is available on our website at accorexpharma.com. Joining me today is David Lucci, President and CEO of Accorex, who will give a corporate update and outlook. Following that, I'll provide some highlights of the financials from the first quarter ended March 31, and then turn the call back over to Dave for 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 in 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 quarterly report on Form 10-Q, which we filed yesterday, Monday, May 12, 2025. You are cautioned not to place undue reliance on these forward-looking statements An 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, May 13th, 2025. I'll now turn the call over to Dave Lucci. Dave?

Thanks, Rob. Good morning, everyone, and thank you so much for joining us to review our financial results for the first quarter of 2025. And if you hear some recent updates, then we'd be pleased to take any questions. First, I'd like to briefly summarize just a few of our key activities for the first quarter 2025, or in some cases shortly thereafter. In January, we announced that we closed a $2.5 million legislative grant offering price at the market under NASDAQ rules. Also in January, we announced that we received positive regulatory guidance from the European Medicines Agency for the Adventist Full-Step Phase 3 Clinical Trial Program, which is aligned with FDA on matters of manufacturing, non-clinical, and clinical aspects of the Phase 3 program. The EMA guidance also confirmed that there's a full-step regulatory pathway for a marketing authorization application to be filed by the company after successfully completing Phase 3 clinical trials. When mutually consistent feedback from both EMA and FDA ACORET is well-positioned to commence our international Phase III registration program. In February and March, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-central studies which we believe can leverage to show further positive differentiation for contentious advances in mycobacteria versus all other antibiotics used for first-line therapy to treat C. difficile infection, or CDI. And for that matter, given our clinical results to date, we anticipate that this anti-recurrence effect, as I said before, could mitigate the patient's need for expensive microbiome therapeutic agents to prevent recurrence C. diff. Specifically, in February, we announced positive results from the first study conducted by Dr. Justin McPherson from the University of Houston, and funded by the National Institute of Allergy and Infectious Beasts. It was an in silico study that predicted the microbiome restorative potential of Ibexifloxac for treating seed death. Our scientific advisors consider this to be a major finding, which provides a mechanistic explanation for Ibexifloxac's selectivity, in that the predicted bactericidal interaction between Ibexifloxac known to confer health benefits. The second study, conducted by Dr. Trenton Wolfe from the University of Montana, was funded by the National Institute of Allergy and Infectious Disease, the National Cancer Institute, National Center for Advancing Translational Science, and ACRES. This study is the first accurate comparison of gut microbiome changes associated with hyperbolic death when compared to other anti-TDI antibiotics in a germ-free mouse model. The data show that changes in alpha and beta microbiome diversities following a desulfocan treatment were less pronounced compared to those observed in vancomycin or methamycin-treated groups, complementing prior Phase II clinical findings showing a desulfocan's more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of the Ibezopulsat and Padexamycin treatment groups, which may allow for a differentiation of these two anti-PDI antibiotics in future studies. These results established Ibezopulsat differentiating effects on the gut microbiome, indicating a more selective spectrum of microbiome alteration compared to a broad spectrum antibiotic like vancomycin and metronidazole, and narrow spectrum microbiome alteration compared to benaxamycin. Also in February, the Japanese Patent Office granted a new patent for our DMA-PAL3C inhibitors, which expires in 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX375, our preclinical anti-spiron program, serving the treatment of infections caused by methicillin-resistant staph, vancomycin-resistant peripapus, and anthrax. In March, we announced the closing of a registered miracle offering and concurrent private placement, raising gross proceeds of $1.1 million. And just last month, the Indian Patent Office granted a new patent for our DNA All-3C inhibitors, which expired in December 2039, subject to extension. This constitutes another significant building block for our ongoing preclinical antibiotic development program, ASEAN 375, which targets the treatment of MRSA, VRE, and anthrax infections. And just last week, at any age, we closed an equity line of credit with Lincoln Park Capital for up to $12 million of additional funding. Looking forward to the weeks ahead, I can share with you that our outstanding faith to clinical trial data has been accepted for publication in the premier medical journal, Lancet Micro, and is now in press to be published shortly and summarizes abeziflofab's safety results, as follows, and I quote, results include a high rate of clinical cure in abeziflofab-treated subjects with no recurrence. Furthermore, abeziflofab is proud to be safe, well-tolerated, and associated with the preservation of key health-promoting bacteria responsible for bile acid homeostasis, a key component in preventing refrained CDIs. The publication establishes that there's a forecast potential as a novel antibiotic treatment for CDIs with high rates of clinical cure and sustained clinical cure while minimally disturbing the protective gut microbiota. The senior author, Professor Kevin Geary, University of Houston, and a co-author of the IESA Treatment Guidelines for TDI, noted that current U.S. and European treatment guidelines for TDI recommend only two antibiotics, oral vancomycin or vancomycin. Vancomycin is most commonly used to have a low clinical cure rate of 70% to 92%, and a sustained cure rate of just 42% to 71%. Pedactomycin has fewer recurrences but low rates of clinical cure, 84%, and sustained clinical cure, 67%. Dr. Gary further notes that both antibiotics are associated with emerging antibiotic antipyrogel resistance, stating what involves the clinical need for a new antibiotic like adenosine for effect to treat TBI is underscored by a recently published study in Clinical Infectious Disease by Dr. Chris Donkey of the T1VA and conducted at hospital setting documented that C. difficile ice was clinically relevant, reduced to asthmatic susceptibility, may emerge during therapy and spread to other patients. The medical community should be aware of this alarming finding, end quote. Also upcoming, regarding the overall GNA-PAL3T inhibitor platform, is a scientific presentation to be given on May 21 by Dr. Nia Urim from Leiden University Medical Center in the Netherlands, entitled, A Unique Intimidator Conformation Selectively Projects the DNA Policy of Gram-Positive Priority Pathogens. This scientific conference is sponsored by the Federation of American Societies for Spearmethobiology and is the premier venue for the newest research and technological trends in molecular machines, inside the human body that ensure DNA replication and expression of genes to create proteins that make up a cell. We continue to identify and pursue funding opportunities for our Phase III Ibenzapulsa clinical trial program. We have several initiatives underway to that end, and we hope to have something to report in future updates. As we've continually reported, Ibenzapulsa clinical results continue to outperform and serious and potentially life-threatening infectious disease caused by C. patella 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, like adenosine folic acid. Adenosine folic acid has FDA QIDC and pass-track designations for the treatment of CDI. We also believe that adenosine folic acid is approved but make a favorable economic impact by reducing the overall annual U.S. cost burden for C. diff infection, which is $5 billion per year, of which $2.8 billion is due to recurrent infection. With our continuing momentum and passion to achieve success for our stakeholders, we remain confident that the best is yet to come as we plow through these very challenging times in the macroeconomic environment and in our industry sectors. And now back to our CFO, Rob Schauer, to guide you through the highlights of our financial results for the first quarter of 2025.