Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals fourth quarter and full year 2024 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 star zero on your telephone keypad. As a reminder, this conference is being recorded. I'll now turn the conference over to your host, Mr. Rob Shawa, Chief Financial Officer for Acurex Pharmaceuticals. Please go ahead, sir.

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 fourth quarter and full year of 2024, which is available on our website at accorexpharma.com. Joining me today is Dave 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 fourth quarter and full year ended December 31, 2024, 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, Monday, March 17, 2025. Your caution not to place undue reliance on these forward-looking statements And Accrax 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 18th, 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 fourth quarter and full year 2024. and also to 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 fourth quarter of 24, or in some cases shortly thereafter, which have been the most significant in our company's history, as we're now finalizing preparation to advance our lead antibiotic candidate, Ibezopulstat, or IBEZ, as we call it, for the treatment of C. difficile infection into international phase three clinical trials. We believe that if successful, this last set of clinical trials to complete will be pivotal to form the basis for our new drug application in the U.S. and marketing authorization application for the European Union. In October 24, we exhibited at ID Week in Los Angeles, which was the annual scientific conference of the Infectious Disease Society of America, where Drs. Gary and Eubank from the University of Houston School of Pharmacy presented a scientific poster showing that in our Phase IIb clinical trial, iBEDS had comparable clinical cure and sustained clinical cure rates and safety profile to becromycin. As previously reported, the overall observed clinical cure rate in the combined Phase II trials, Phase IIa and Phase IIb, in patients with CDI was 96%, 25 out of 26 patients, And importantly, 100%, or 25 of 25, of the IBEZ-treated patients in the Phase II program who had clinical cure at the end of treatment remains cured through one month after EOT, as compared to just 86%, 12 of 14 patients in the vancomycin treatment arm in Phase IIb. Also, in a subset of IBEZ or PULSTAT patients, Five of five followed for three months after the end of treatment experienced no recurrence of infection. IBEZ-treated patients showed decreased concentration of fecal primary bile acids and higher ratios of secondary to primary bile acids than vancomycin-treated patients. According to Dr. Gary, these exciting results demonstrate two properties of IBEZ-epolstat which may contribute to its anti-recurrence effect. First, the preservation and restoration of beneficial bacteria classes in the gut provide resistance to recolonization by C. difficile. Second, these data presented for the first time indicate that these beneficial bacteria known to metabolize primary to secondary bile acids persist in ipazepulstat-treated patients, providing another important mechanism to prevent recurrent CDI. In November last year, we announced sponsorship and participation in the inaugural Peggy Willis Foundation, CDI Scientific Symposium, and presented an IBEZA polls that face to the clinical data update. In January 25, the company announced that it closed the $2.5 million registered direct offering priced at the market under NASDAQ rules. Also in January 25, we announced that we received positive regulatory guidance from the European Medicines Agency for the Ibex and Polestat Phase III clinical trial program, which guidance is aligned with FDA on matters of manufacturing, non-clinical, and clinical aspects of the Phase III program. The EMA guidance also confirmed Ibex and Polestat's regulatory pathway for a marketing authorization application to be filed by the company after successful completion of the Phase III clinical trials. So now with mutually consistent feedback from both the EMA and FDA, Acorex is well positioned to commence our international phase three registration program. This past February and just this month, we announced new publications in the Journal of Antimicrobial Agents and Chemotherapeutics of two very important non-clinical studies which we believe can leverage to show further positive differentiation for competitive advantage of IBEZ as compared with all other antibiotics used for frontline therapy to treat C. difficile infection. And for that matter, given our clinical results to date, we're hopeful that this anti-recurrence effect of IBEDS could mitigate the need for expensive microbiome therapeutic agents to prevent recurrent CDI. In February, we announced positive results from this first study conducted by Dr. Justin McPherson from the University of Houston and funded by the National Institute of Allergy and Infectious Diseases, or NIAID. It was an in silico study that predicted the microbiome restorative potential of I-bez for treating C. difficile infection. Our scientific advisors consider this to be a major finding, which provides a mechanistic explanation for I-bezoplastat selectivity in that the predicted bactericidal interaction between I-bez and its target the DNA Pol3C enzyme, allows regrowth of gut microbes known to confer health benefits. The second study, conducted by Dr. Trenton Wolfe from the University of Montana, was funded by NIAID, the National Cancer Institute, National Center for Advancing Translational Sciences, and the company. The second study is the first ever head-to-head comparison of gut microbiome changes associated with IVEZ when compared to other anti-CDI antibiotics in a germ-free mouse model. The data showed that changes in alpha and beta microbiome diversities following IVEZ treatment were less pronounced compared to those observed in vancomycin or metronidazole-treated groups, complementing prior Phase II findings showing IVEZopil sets more selective antibacterial activity. Further, and very importantly, notable differences were observed between the microbiome of Ibezopulstat and the Fedaxomycin-treated groups, which may allow for differentiation of these two anti-CDI antibiotics in future studies. These results established Ibezopulstat's differentiating effects on the gut microbiome indicating a more selective spectrum of microbiome alteration compared to broader spectrum antibiotics like vancomycin and metronidazole, and a narrower spectrum of microbiome alteration compared to finaximiacin. Also in February 25, last month, the Japanese Patent Office granted a new patent for our DNA glenraze 3C inhibitors, which expires in December 2039, subject to extension. This constitutes a significant building block for our ongoing development of ACX375C, our preclinical antibiotic candidate, targeting the treatment of MRSA, VRE, and anthrax infections. On March 10th, just a week ago, we announced the closing of a registered direct offering and concurrent private placement, raising gross proceeds of $1.1 million. We continue to identify and pursue funding opportunities for our Phase III clinical trial program. We have several initiatives underway to that end and hope to have something to report in future updates. So now we've got even more momentum going into 2025 and beyond. As we've continually reported, I-VEST clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by acetobacillus 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. From a regulatory perspective, FDA has granted IBEZ, QIDP, and fast-track designations for the treatment of C. difficile infection. We also believe that Ibezapulsa, if approved, could make a favorable economic impact by reducing the overall annual cost burden in the U.S. for C. difficile infection, $5 billion annually, of which $2.8 billion is due to recurrent infection. And that's what our data shows we may solve for. With our continuing momentum and passion to achieve success for our stakeholders, we do believe the best is yet to come. And now back to our CFO, Rob Schauer, to guide you through the highlights of our financial results for the fourth quarter and full year 2024. Rob?