Acurx Pharmaceuticals, Inc.

Ladies and gentlemen, good morning and welcome to the Acurex Pharmaceuticals Third Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rob Shawah, Chief Financial Officer. Please go ahead.

Thank you, Ryan. 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 2023, which is available on our website at accorexpharma.com. Joining me today is Dave Lucci, President and CEO of Accorex. will give a corporate update in Outlook, and Bob DeLuccia, our executive chairman, who will provide his perspective as the manager of our development programs, including the Phase II clinical trial. After Dave's comments, I'll provide some highlights of the financials for the quarter ended September 30th, 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 quarterly report on Form 10-Q, which we filed yesterday, Monday, November 13th, 2023. You are cautioned 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, November 14th, 2023. Accrax undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date and time of this conference call. I'll now turn the call over to Dave Luci.

Dave? Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the third quarter and also to cover some exciting recent updates. Then we'd be pleased to take any questions. On October 2nd, 2023, we ended enrollment in our Phase IIb clinical trial of Ibezapulstead, 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 II clinical trial, including the Ibenzapulstat clinical cure rate at end of treatment, or EOT, of 96%, 25 out of 26 patients, including 100% in Phase IIa, 10 for 10, and 94% in Phase IIb, 15 for 16. as well as the cure rate for oral vancomycin at EOT of 100%, 14 of 14. No safety concerns were reported in either arm of the Phase 2B clinical trial or in the Phase 2B open-label trial. Based on the Phase 2 data, in consultation with our scientific advisors, we determined that clear evidence of clinical cure has been established with Ibezopulstat and it is clinically comparable to vancomycin. and Bezopulstat will now move forward to Phase III clinical trials. Further data will be provided when available on all of the secondary and exploratory endpoints in the Phase IIb trial, including sustained clinical cure, extended clinical cure up to 94 days, and the comparative impact on the microbiome. We anticipate that these secondary and exploratory endpoints will provide clear separation between these two therapeutic options and all of these endpoints will be disclosed when available over the next 90 days. The Phase 2b trial was originally designed to be a non-inferiority trial and later amended to include an interim efficacy analysis with review by an independent data monitoring committee or IDMC. The decision to end the trial early based on the blinded clinical observations obviated the need for an interim analysis, the need for the IDMC review and the Non-Inferiority Assessment. The company determined in consultation with its clinical and statistical experts that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of Ibezopolstat in treating C. diff infection. We remain particularly excited about the dual impact of Ibezopolstat to treat the acute C. diff infection while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy. Other key highlights from the third quarter, or in some cases shortly thereafter, include the following. The World Antimicrobial Resistance Congress convened its annual meeting in Philadelphia in September 2023, where experts in the field from both the public and private sectors weighed in on the latest innovations to address antimicrobial resistance. Our executive chairman with us today, Bob DeLuccia, presented an update entitled Novel DNA Pol3C Inhibitors for Gram-Positive Bacterial Infections, Preparing for the Next Pandemic. This presentation, as well as the others that I'll describe, is available on our website at xrxpharmaceuticals.com. At ID week, which convened in Boston October 11 to 15. Accorex was featured at two scheduled events. First, an oral presentation was provided by Dr. Kevin Gary, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for Microbiome Aspects of our Ibezopolstat Trial Program entitled, Elucidating the Gram-Positive Selective Spectrum Activity of Ibezopolstat, Secondary Analysis from the Phase 2A Trial. Secondly at ID Week, Actorex presented at the symposium entitled New Antimicrobials in the Pipeline. At the symposium, Actorex's presentation was entitled Novel DNA PAL3C Inhibitors for Gram-Positive Bacterial Infections. Next up was the CLOSPATH meeting, the International Conference on Molecular Biology and Pathogenesis of Clostridia, at which there were three scientific Thank you very much. The second, entitled C-Diff In Vitro Biofilm Studies of Ibezopolstat and Comparator Antibiotics, showed Ibezopolstat was as effective as the currently used anti-C-Diff antibiotics, Fedaxamycin, Vancomycin, and Metronidazole, reducing biofilm-embedded C. difficile. The third, entitled Metagenomic evaluation of Ibezopolstat compared to other anti-C. diff agents showed Ibezopolstat and Fedaxamycin both caused favorable proportional increases in bacterial DDs, but distinct from Vancomycin and Metronidazole, which caused unfavorable proportional increases in protobacteria. All the presentations, again, are available on our website. and now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the third quarter of 2023. Rob?