Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals Report's fourth quarter and full year 2023 earnings results and business update call. 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 would now like to turn the call over to your host, Rob Shawa, Chief Financial Officer for Acurex 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 fourth quarter and full year 2023, which is available on our website at accorexpharma.com. Joining me today is David Lucci, President and CEO of Accorex, as well as Robert DeLuccia, Executive Chairman. David will give a corporate update and outlook. After that, I'll provide some highlights of the financials from the quarter and year ended December 31, 2023, 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 annual report on Form 10-K, which we filed on Friday, March 15, 2024. You are cautioned 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, March 18th, 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 fourth quarter of 2023, 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 fourth quarter of 23, or in some cases, shortly thereafter. On October 2nd, 2023, we ended enrollment in our Phase 2B clinical trial of Ibezapolstat, or IBEZ, our lead antibiotic candidate for the treatment of patients with C. difficile infection, or CDI. On November 2nd, 2023, we reported top-line data from the Phase 2B clinical trial, including overall results from the full Phase 2 study, demonstrating an Ibezapolstat clinical cure rate at end of 10 days oral treatment, or EOT, of 96%, 25 of 26 patients, which included 100% cure in phase 2A and 94% cure in phase 2B, compared with vancomycin control arm, which was 14 for 14 or 100% at end of treatment and 94% with sustained cures. No safety concerns were reported in either arm of the Phase 2B clinical trial. It had been a post that was well-tolerated in all patients in both the Phase 2A open-label trial and the Phase 2B vacuumizing controlled segment. In consultation with our scientific advisors, the company determined that based on review of aggregate blinded data, the Phase 2B vacuumizing controlled trial segment was terminated early due to success showing high observed clinical cure rates with no emerging safety concerns. Clinical comparability was established. We also stated that further data would be provided as it becomes available on secondary and exploratory endpoints for the Phase IIb trial segment, including sustained clinical cure data at 30 days after EOT and extended clinical cure data 94 days after EOT, as well as comparative data on the impact on the patient's microbiome. On December 11th, 23, we announced the sustained clinical cure data. These data showed that in the phase 2B trial segment, 100%, or 15 of 15, of our IBEZ patients who were cured at EOT remained cured with no reinfection 30 days later, while vancomycin experienced a reinfection rate of 14.3%. Two of 14 patients were reinfected. On January 17th, 2024, we announced positive comparative microbiology and microbiome data for the Ibezapolstat and CDI patients from the Phase IIB clinical trial segment. Ibezapolstat outperformed vancomycin, showing eradication of fecal C. difficile at day three of treatment in 15 of 16 treated patients versus vancomycin, which had eradication of C. difficile in just 10 of 14 treated patients. Additional data from the Phase IIb clinical trial showed abezopulsat but not vancomycin consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits, including prevention of recurrent C. difficile infection. We anticipate that additional data from these secondary and 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. Additional analyses regarding our secondary and exploratory endpoints will be forthcoming as they become available. We remain particularly excited about the dual impact of Ivesifolstat to treat acute C. difficile infection while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy. Having robust preclinical, clinical, and manufacturing data to date, we submitted a formidable information package in early February to FDA, along with a request for an end-of-Phase II meeting, which was granted by FDA on Feb. 26 and is scheduled to occur in April. We anticipate discussing our Phase III clinical trial mandate at this meeting and would anticipate documented meeting minutes from FDA sometime in the second quarter this year. We also 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 European Medicines Agency for seeking a marketing authorization in Europe. In November 2023, we filed an amendment to our shelf registration statement with the Securities and Exchange Commission and put up a $17 million at-the-market, or ATM, facility with Alliance Global Partners acting as sales agents to the company. Proceeds from the ATM will be used for general corporate purposes going forward, including our planned Phase 3 clinical trial mandate. In October 2023, at ID Week, Dr. Kevin Geary presented on our behalf with selective spectrum of activity data from our Phase IIa clinical trial. Many of you may recall Dr. Gary is professor and chair, University of Houston College of Pharmacy, and the principal investigator for our microbiome aspects of the Abesapulset clinical trial program. Also at IDWeek, Bob DeLucia, our executive chairman, presented our new class of novel DNA Pol3C inhibitors in our pre-clinical pipeline at the symposium entitled new antimicrobials in the pipeline. Now, that's a lot of activity to digest, so I'll summarize further as to where we are today. As we speak, we're preparing to advance Ibenzapulset into Phase III clinical trials and anticipate a favorable outcome from our upcoming FDA meeting regarding readiness to proceed and also to obtain agreement on the regulatory pathway for a new drug application filing for marketing approval in the U.S. once phase three is completed. We've also officially started the regulatory process in Europe. We'll add other territories to the list later this year. The phase three trials will include U.S. and international sites to enhance overall enrollment and to support international regulatory filings for marketing approval. This will save us a lot of time and money and allow us to expand our ultimate commercial reach. To ensure Phase 3 clinical trial enrollment as quickly as possible, we're adding substantially more clinical trial sites, way above the number we used to conduct our U.S.-only Phase 2 trials. We're now getting our arms around the costs and timelines, but our plan is to conduct the required two Phase 3 registration trials consecutively, not concurrently, given the size of our company and need to use our financial resources most efficiently. The timeline for conduct of our Phase III trial is not a concern since Ibeza Polstad will have a rolling 10 years of regulatory exclusivity in the U.S. from the FDA approval date with similar legislation in Europe, the U.K., and Japan. We will continue to seek a strategic transaction for the company, including a potential partner for the further development and potential commercialization of Ibeza Polstad as well as a potential sale, merger, third-party ex-U.S. territorial licensing arrangement, or other strategic transaction, alongside and in parallel with our preparation for Phase III clinical trials. At this time, we have no commitments from potential partners or others to provide the company with capital, but we started this initiative only recently, in February, after our Phase IIb data was released. So basically, we have two formidable Plans A going forward, and we're equally excited about partnering M&A and Phase 3 enrollment as next steps over the next 12 months. As we've consistently reported, Abesipulostat continues to outperform in a serious and potentially life-threatening infectious disease called C. difficile that the U.S. CDC categorizes as an urgent threat, and there's a need for new classes of antibiotics for initial treatment It also has a low incidence of recurrence. Ivesipulset also has FDA fast-track designation for treatment of C. difficile infection. Additionally, we believe Ivesipulset, if approved, could make a favorable impact by reducing the cost burden of current 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 Shalab, to guide you through the highlights of our financial results for the fourth quarter and full year 2023. Rob?