Acurx Pharmaceuticals, Inc.

Hello, and welcome to the AccuRx Pharmaceuticals first quarter 2024 financial results conference call. If anyone would require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star one. As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to CFO Robert Shala. Please go ahead.

Thank you, Kevin. 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 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, as well as our Executive Chairman, Bob DeLuccia. After that, I'll provide some highlights of the financials from the quarter ended March 31, 2024, then turn the call back over to Dave and Bob for their 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. They're 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, May 14th, 2024. Your caution not to place undue reliance on these forward-looking statements and that corrects, disclaims any obligation to update these 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 15, 2024. I'll now turn the call over to Dave Lucci. Dave?

Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the first quarter and also to hear some exciting recent updates. Then we'd be pleased to take any questions. First, I'll summarize some of our key activities for the first quarter of 2024. or in some cases, shortly thereafter. In January, we announced positive comparative microbiology and microbiome data for Ibezopulstat, our lead antibiotic candidate, in C. diff patients from the Phase IIb clinical trial segment. Ibezopulstat outperformed vancomycin, a standard of care, showing eradication of fecal C. difficile at day three of treatment in 15 of 16 patients. treated patients, 94%, versus vancomycin, which had eradication of C. difficile in 10 of 14 treated patients, or 71%. Additional data from the Phase IIb clinical trial showed that Bezopulstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits, including preventing recurrent C. diff infections. Additional data from exploratory endpoints will provide further favorable separation between these two therapeutic options in our Phase III clinical trial program and ultimately in the marketplace, if approved. We remain particularly excited about the dual impact of ibuprofen to treat acute C. difficile on the one hand, while appropriately managing the long-term care of each patient's microbiome, which we believe is truly exceptional for antibiotic therapy. Having robust preclinical, clinical, and manufacturing data to date, we submitted in January a formable information package to the FDA, along with a request for an end-of-Phase II meeting, which was granted on February 26th, and the meeting was convened on April 17th. At the FDA meeting, we reached agreement on key elements of our Phase III program. including, importantly, agreement with the FDA regarding readiness to proceed to Phase 3, as well as agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. We will press release further details on the FDA meeting pre-market this morning. In February, we announced that the European Medicines Agency approved our application to be designated as a Small to Medium-Sized Enterprise, or SME. in Europe, which provides for certain benefits, including fee reductions and other support from the agency, for seeking a marketing authorization in Europe. We attended the European Society of Microbiology and Infectious Disease, or ESCMID, scientific congress in April 2024, where Dr. Kevin Geary, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiology and microbiome aspects of our clinical trial program, and our scientific advisory board member, provided an oral presentation of Phase II data entitled, A Phase II Randomized Double-Blind Study of Ibezapustat Compared with Vecamisin for the Treatment of C. difficile Infection. The presentation included additional analyses of clinical and microbiological data and is available on our website at www.accurexpharmaceuticals.com. The complete Phase II results are being prepared for submission to a prominent scientific journal for publication this year. Throughout the rest of this year, we'll continue to roll out our Phase II results in either oral presentations or scientific posters, or in some cases both, which will include results from new analyses as data become available at various prominent scientific conferences, including the Houston C. diff and microbiome conference later this month, the Antirope Society of America annual conference in July, the World Antimicrobial Resistance Conference in September, also in September is the International C. diff Symposium, and, of course, the annual meeting of the Infectious Disease Society of America, or ID Week, in October. Throughout the first quarter, we continued preparations for Phase III trials, including advances in micro and manufacturing, CRO selection and clinical site screening, and building a team of international drug development experts to support our Phase III mandate. To ensure Phase III clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number used to conduct the U.S.-only Phase II trials. We're now finalizing costs and timelines, and our plan is to conduct the required two Phase III registration trials consecutively, not concurrently, given the size of our company and need to use our financial resources most efficiently. The timeline to conduct our Phase III trials is not a concern, since I've as opposed that we'll have a rolling 10 years of regulatory exclusivity in the U.S. from the date of the FDA approval. with similar exclusivity available in Europe, the UK, Japan, and Canada. We will continue to seek a strategic transaction for the company, including a potential partnership for the further development and potential commercialization of Ivesa Polestat, alongside preparation for phase three in our build-up strategy. At this time, we have no commitments from potential partners or others to report But now having FDA confirmation of the registration plan, this has become an active initiative. As we've consistently reported, Ibenzapulstat clinical results continue to outperform in a serious and potentially life-threatening infection. The CDC categorizes C. difficile as an urgent threat and calls for new classes of antibiotics for initial treatment that also have a low incidence of recurrence. Ibezapulsa is also FDA fast-track designated for the treatment of C. difficile infection. Initially, we believe Ibezapulsa, if approved, could make a favorable impact by reducing the cost burden of recurrent C. diff infection on the 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 Schauer, to guide you through the highlights of our financial results for the first quarter.