Acurx Pharmaceuticals, Inc.

Greetings. Welcome to the Acurex Pharmaceuticals second quarter 2024 financial results. At this time, all participants are in listen-only mode. The question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. Please note this conference is being recorded. At this time, I'll now turn the conference over to Rob Bawa, Chief Financial Officer. Rob, you may begin.

Thank you, Rob. Thank you, Rob. Good morning, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the second quarter, 2024, which is available on our website at accorexpharma.com. Joining me today is Dave Lucci, President and CEO, who will give a corporate update and outlook. After that, I'll provide some highlights of the financials from the quarter ended June 30th, 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 10Q, which we filed on Thursday, August 8, 2024. Your caution not to place any undue reliance on these forward-looking statements, and ACRx 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, August 9, 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 second quarter of 2024, and also to hear some very exciting recent updates. Then we'll be pleased to take any questions. First, I'll summarize some of our key activities for the second quarter, or in some cases, shortly thereafter. In April, we completed a successful end-of-Phase II meeting with the FDA, confirming Phase III readiness for Ibezopustat, our lead antibiotic candidate, to enter Phase III clinical trials for the treatment of C. difficile infection. Agreement with FDA was reached on key elements to move forward with our international Phase III clinical trial program. Agreement was also reached with FDA on a complete non-clinical and clinical development plan for filing of a new drug application, or NDA, for marketing approval. We've since continued activities to advance Ibex and Polestat into international phase three clinical trials for the treatment of C. difficile infection. In parallel, we're also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, the United Kingdom, Japan, and Canada. Also in April, we attended the European Society of Microbiology and Infectious Disease, or ESCMID, scientific conference. Dr. Kevin Gary provided an oral presentation of our Phase II data entitled, A Phase II Randomized Double-Blind Study of Ibexipolstat Compared with Vancomycin for the Treatment of C. difficile Infection. Dr. Gary is professor and chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of the Ibezopolistat clinical trial program. And he's a scientific advisory board member for AccuRx. The oral presentation included additional analyses of clinical and microbiological data and is available on our website at accurexpharma.com. The complete phase two results are being prepared for submission to a prominent scientific journal for publication. Also in July, results from the Iveza-Polstad Phase II clinical trial in patients with C. difficile infection were presented at the 17th Biennial Congress of the Antirope Society of the Americas by Taryn Eubank, PharmD, Research Assistant Professor, University of Houston College of Pharmacy. And Taryn's oral presentation was entitled clinical efficacy of Ibezapolstat in CDI, C. difficile infection, results from Phase II trials. Also in July, and very timely given our late-stage development progress, the United States Patent and Trademark Office, or USPTO, granted us a new patent for Ibezapolstat, 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, and we think will provide an important downstream competitive advantage. And finally, some late-breaking news today. Following our successful end of Phase II clinical meeting with the FDA, which confirmed our Phase III clinical trial readiness, and according to FDA regulatory requirements, we submitted our request to FDA for a meeting to review our manufacturing processes and specifications for drug substance and final product and packaging, typically referred to as CMC or chemistry manufacturing and controls for our phase three clinical trials. We anticipate FDA to grant the meeting in the fourth quarter. So now we have further momentum as we continue to seek one or more strategic transactions for the further development and potential commercialization of our lead antibiotic candidate at Beza Polestat, territory or globally, in parallel with ongoing preparation for phase three clinical trials. We will provide a detailed update on our partnership transactions if and when we reach agreement with the third party. Throughout the rest of this year, we'll continue to roll out our phase two results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data becomes available at various prominent scientific conferences, including the World Antimicrobial Resistance Conference in Philadelphia this September. Also in September is the Eighth International C. difficile Symposium in Bled, Slovenia, which is the premier global venue for the review of C. difficile research. And in October, we'll be presenting at the annual meeting of the Infectious Disease Society of America or ID Week in Los Angeles. As we've continually reported, I've been supposed that clinical results continue to outperform in a serious and potentially life-threatening infectious disease caused by C. difficile bacteria that the Center for Disease Control categorizes as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ivesipulsa also has FDA fast-track designation for treatment of C. difficile infection. Additionally, we believe Ivesipulsa, if approved, could make a favorable impact by reducing the cost burden of recurrent C. difficile infection on our U.S. healthcare system, which is estimated at $4.7 billion annually. We do believe the best is yet to come. And now back to our CFO, Rob Schallet, to guide you through the highlights of our financial results for the second quarter of 2024. Rob? Thanks, Dave.