Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals Inc. Third Quarter 2024 Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. Should anyone require 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, Robert Shawa, Chief Financial Officer of Thank you. You may begin.

Thank you. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the third quarter 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. After that, I'll provide some highlights of the financials for the quarter ended September 30, 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. These forward-looking statements 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 made with the Securities and Exchange Commission, including our quarterly report on Form 10-Q, which we filed on Tuesday, November 12, 2024. 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, November 13th, 2024. I'll now turn the call over to Dave. Dave?

Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the third quarter of 2024 and also to hear some very exciting recent updates. Then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the third quarter of 2024 or in some cases, shortly thereafter. In July, results from the Ibezopolstat Phase II clinical trial in patients with C. diff infection were presented at the 17th Biennial Congress of the Antirope Society of the Americas by Taryn Eubank, PharmD Research Assistant Professor at the University of Houston College of Pharmacy. Taryn delivered an oral presentation entitled Clinical Efficacy of Ibezopolstat in CDI, results from Phase II trials. Also in July, the USPTO granted Acurex a new patent for the Ibezopolstat, which specifically encompasses the treatment of C. difficile infection while reducing recurrence of infection and improving the health of the gut microbiome. This patent expires in June 2042, subject to extension, if any, and we think will provide an important downstream competitive advantage. We also filed other patent applications with the USPTO in the third quarter, but we'll discuss those down the road if and when these patents are issued. In August, following our successful end of phase two clinical meeting with the FDA, which confirms our phase three clinical trial program readiness, and per FDA requirements, we submitted a manufacturing request to the FDA. for a meeting to review our manufacturing processes and specifications for drug substance and final product packaging. This will allow us to move forward to phase three clinical trials. FDA granted a meeting date in late October, which we did not meet because of our successful pre-meeting correspondence with the FDA. So from a regulatory perspective, we're delighted to announce CMC readiness for phase three in addition to FDA agreement on our clinical plan forward for phase three. In September, a presentation was given by ACRx executive chairman, Bob DeLucia, at the World Antimicrobial Resistance Scientific Congress held in Philadelphia. As many of you may know, Bob has over 50 years industry experience in new antibiotic development and commercialization, and is responsible for our clinical development programs, including Fribeza Polestat. In his presentation at the innovation showcase session, Bob highlighted that we have a complete roadmap, not only for the required components of our phase three clinical program, but also what's required for ultimate filing of an NDA, which is to be followed by submissions for marketing authorizations in other countries around the world. Bob also presented an update on the company's preclinical gram-positive selective spectrum program for systemic oral and IV treatment of other gram-positive infections. including MRSA, VRE, and DRSP. Bob summarized our progress, stating that we've made substantial progress toward lead compound selection of our gram-positive IV and oral compounds. Our current focus is to prioritize the oral form for acute bacterial skin and skin structure staph infections, including MRSA, to speed lead product selection and advancement to clinical trials. We also participated at the 8th Annual C. difficile Symposium, or ICDS, in Bled, Slovenia, which is the premier global venue for the review of C. difficile research. At the ICDS meeting, two presentations were made on our behalf. First, Dr. Kevin Geary, Professor and Chair, University of Houston College of Pharmacy, made a presentation on our behalf regarding Ibezopolstat's Phase IIb results. and its preservation of key bacterial species, which was an unexpected finding of a unique microbiome signature in two vancomycin-treated patients in the Phase IIb trial who experienced recurrence of CDI. Since these changes were evident and observed early during treatment and then consistently until the end of therapy, they may be predictive of pending CDI recurrence and suggest the need to modify therapy. Accordingly, as we move ahead to our planned international phase three clinical trials, we will continue to evaluate what we call our predictive model to determine if there may be a pathway forward toward commercialization as a new diagnostic tool or test kit, if you will. Second, in Bled, Slovenia, Dr. Wieb Klaus-Smits, Associate Professor, Leiden University Medical Center in Holland, delivered a presentation on the mechanism of action of PAL3C inhibitors. These definitive data result from our multi-year partnership with LUMC and the Dutch government to perform pioneering research on the PAL3C mechanism of action. Dr. Smits emphasized that his findings with Ibeza-Polstad regarding the structural biology of DNA PAL3C inhibitors have important implications for the development of a new family of antibiotics to treat high-priority, multidrug-resistant gram-positive infections, and that this novel class of DNA-PAL3C inhibitors could be an important new tool to address the pandemic of antimicrobial resistance. Also in the quarter, we announced that selected ACX375 DNA-PAL3C analogs demonstrated in vitro activity against anthrax, which is a bioterrorism category A pathogen, including activity against ciprofloxacin-resistant anthrax. This work was performed at two independent qualified laboratories, including the University of Florida. Planning is underway for an anthrax bioterrorism development program. In October, we participated at ID Week in Los Angeles, the annual scientific conference of the Infectious Disease Society of America. Doctors Kevin Gary and Taryn Eubank presented a scientific poster showing that in the Phase IIb clinical trial, Ibezopolstat had comparable clinical cure and sustained cure rates and safety profile to vacumycin, the standard of care. Also, five of five Ibezopolstat patients who were followed for a full three months after the end of treatment experienced no recurrence. Ibezopolstat-treated patients showed decreased concentrations 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 Ibezopolstat which may contribute to its anti-recurrence effect. First, the preservation and restoration of beneficial bacterial classes in the gut provide resistance to recolonized 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 Ibezopolstat-treated patients, providing another important mechanism to prevent recurrent CDI. So now we have even more momentum going into the fourth quarter. As we've continually reported, Ibezopolstat clinical results continue to outperform in a serious and potentially life-threatening infectious disease called C. difficile bacteria that the U.S. CDC categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ibezapolstat also has FDA QIDP and fast-track designation for the treatment of CDI. Additionally, we believe that Ibezapolstat, if approved, could make a favorable economic impact by reducing the overall annual U.S. cost burden for C. difficile infection of approximately $5 billion per year, of which $2.8 billion is due to recurrent CDI infection. Given our continuing momentum, we do believe the best is yet to come. And now back to our CFO, Rob Schala, to guide you through the highlights of our financial results for the third quarter. Rob?