Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals to discuss second quarter 2023 financial results and business update. 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 zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Rob Shawah, Chief Financial Officer. Thank you, sir. 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 second quarter of 2023, which is available on our website at accorexpharmaceuticals.com. Joining me today is Dave Lucci. President and CEO of Acorex, who will give a corporate update and outlook for 2023. After that, I'll provide some highlights of the financials from the quarter ended June 30th, and then turn the call back to Dave for his closing remarks. Joining me 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 Friday, August 11th, 2023. You are cautioned not to place undue reliance on these forward-looking statements and AccuRx 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 14th, 2023. Agra X 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 Lucci. Dave?

Thanks, Rob. Good morning, everyone, and thanks for joining us to review our financial results for the second quarter of 2023 and also to cover some recent updates. Then we'd be pleased to take any questions. In the second quarter of 2023, we continue to enroll more patients in the Phase 2B clinical trial of our lead antibiotic candidate, Ibezopolstat, for the treatment of patients with C. difficile infection, or CDI. We're pleased to report we now have enrolled 31 patients in the Phase 2B trial, so only five more patients need to be enrolled to trigger interim data review by an independent data monitoring committee that we appointed in the first quarter of 23 for this purpose. The IDMC will review the data upon the 36 patients being evaluated for the primary endpoint of clinical cure at the end of treatment and promptly provide its recommendation either to early terminate the 2B trial, as we had done with the Phase 2A trial, or alternatively to continue enrolling. We'll report the IDMC recommendation after the interim review of the data. If the IDMC recommends early termination of the 2B trial, will promptly report the top-line data on the primary endpoint and safety data when the 36th enrolled patient completes treatment. We anticipate completing enrollment of the 36 patients for the interim review in the coming month or two. Operationally, we're pleased to report that the blind and observed data from the Phase 2b trial has been exceptional, and the trial is proceeding as expected with no safety signals reported to date. The Phase IIb Trial Protocol includes an exploratory endpoint comparing the impact on the microbiome between ibezopolstat and standard of care oral vancomycin. In the event non-inferiority of ibezopolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Due to slower than expected enrollment during the COVID-19 pandemic and its aftermath, We did expand the number of trial sites participating in the 2B trial from the initial 12 sites up to 28 sites, as we now have, and have increased support to higher enrolling sites, resulting in increased screening in the past couple of months. In March 2023, the FDA accepted our protocol amendment to our IND, which will allow an independent data monitoring committee to review the interim data that's been pre-cleared with the FDA. We remain particularly excited about the dual impact of ibuprofen at the same time to treat the acute infection, the 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 second quarter of 23, or in some cases shortly thereafter, include the following. In April of this year, two presentations were made at the 33th Annual European Congress of Clinical Microbiology and Infectious Disease, or ECMID, in Copenhagen. First, a scientific poster entitled, Novel Pharmacology and Susceptibility of Ibezopulsat Against C. diff Isolates with Reduced Susceptibilities to C. diff Directed Antibiotics, end quote, was presented by Dr. Kevin Geary, Professor and Chair, University of Houston College of Pharmacy, and the principal investigator for microbiome aspects of our Ibezopolstat clinical program. Dr. Gary's work demonstrated that Ibezopolstat's mechanism of action is not only bactericidal to C. diff, but also could inhibit some of its viral mechanisms, meaning its capability to cause disease. Dr. Gary also noted that C. diff strains with reduced susceptibility Any of the other antibiotics used to treat C. diff, metronidazole, vancomycin, or finacomycin, those C. diff strains were susceptible to Ibezopulstat. So just to say it again, Ibezopulstat is able to successfully kill C. diff bacteria that in many cases is resistant to all the other antibiotics used to treat C. diff currently. Ibezopulstat's antiviral effect, namely reduced flagellar movement, of the C. diff. organism was a positive, unexpected finding, reflecting the unique mode of action in inhibiting DNA-PAL3C. In the second of two presentations at ECMID, ACRES' executive chairman, Bob DeLuccia, presented an update regarding the company's preclinical systemic oral and IV program for the treatment of other gram-positive infections caused by MRSA, VRE, and DRSP in the pipeline corner featured session at ECMID. organized by Dr. Ursula Ferretzbacher, a world-renowned microbiology expert involved in antibacterial drug research, discovery and development strategies, and policies for clinical and public health needs. Bob summarized the progress of the company's grant-positive Select Spectrum program.