Acurx Pharmaceuticals, Inc.

Greetings and welcome to the AccuS Pharmaceuticals, Inc. first quarter 2022 results and business updates. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. If anyone should require an operator during the conference, click the star and then zero on your keypad. As a reminder, the conference is being recorded. I would now like to turn the conference over to your host, Robert Shawah, Chief Financial Officer. Please go ahead.

Thank you. 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 2022. This press release is available on our website at acrexpharmaceuticals.com. Joining me today is Dave Lucci, President and CEO of Acrex, will give a corporate update and outlook for the remainder of 2022. After that, I'll provide some highlights of the financials from the quarter ended March 31, 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, Tuesday, May 10th. 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, May 11th. 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 Lucci. Dave?

Thanks, Rob. Good morning, everyone, and thanks for joining us on this conference call to review our financial results. During today's call, we'll review our financial results for the first quarter ended March 31, and also cover some key corporate highlights, and then we'd be pleased to take any questions. In the first quarter, more patients were enrolled in the Phase 2B clinical trial of Ibezapulset, our lead antibiotic candidate, for the treatment of patients with C. difficile infection, or CDI. The Phase 2B clinical trial is a 64-patient, randomized one-to-one, non-inferiority, double-blind trial of oral ibuprofen compared to oral vancomycin, a standard of care to treat CDI. The primary endpoint of the Phase IIb trial is clinical cure of the C. difficile infection at the end of treatment measured on Day 12, and a secondary endpoint is sustained clinical cure measured at Day 38 follow-up visit. Since this is a double-blind trial, results will not be known until the end of the trial. However, operationally, the trial is proceeding as expected, signals reported to date. Also included in the protocol is an exploratory endpoint comparing the impact on the microbiome between ibezopolstat and vancomycin. In the event non-inferiority of ibezopolstat to vancomycin is demonstrated in the Phase IIb trial, further analysis will be conducted to test for superiority. Additionally, based on the strength of our previously reported Phase IIa results, which demonstrated 100% clinical cure in patients after a 10-day treatment for CDI with no recurrences of infection at the day 38 follow-up visit, we've added a novel exploratory endpoint in the Phase IIb trial of extended clinical cure, or ECC, for study visits at day 56 and day 84 after the end of treatment for a selected group of subjects to evaluate the longer-term effect of ibuprofen on the microbiome and on disease recurrence. To our knowledge, no other comparable long-term data such as this has been conducted or reported with currently used antibiotics to treat C. difficile infection to date. The Phase 2B clinical trial will include up to 24 U.S. sites with enrollment expected to be completed late in the second half of this year. We remain particularly excited about the dual impact of using Ivesipulstat to treat the acute infection, CDI, while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy. We reiterate that with the closing of our IPO in June 2021, we have more than enough cash to complete the Ibezapolstat Phase 2b trial and related R&D matters, as well as to allocate resource to advance development of ACX375C, our second DNA Pol3C inhibitor, currently in lead optimization stage of preclinical development for the treatment of other gram-positive bacterial infections, including MRSA. Other key highlights from the first quarter of 22 include the following. Our laboratory study at the University of Houston comparing microbiome changes of Ibezopulstat to vancomycin, fidaxamycin, and metronidazole using both in vitro and ex vivo analyses is ongoing. The objective of this study is to expand our very positive Phase I and Phase IIa microbiome data using an in vitro gut model that mimics human gastrointestinal physiology. Shortly after the end of the first quarter, we submitted a grant application to the NIH National Institute of Allergy and Infectious Disease for approximately $23 million of non-diluted funding to support the ongoing development of ACX375C. If approved, these funds would cover the costs of ACX375C all the way through phase one clinical trials for our lead clinical indication including reimbursement to the company for certain GNA costs. The company anticipates a final decision on this funding opportunity in the second half of this year and we will continue to monitor other potential funding opportunities and we do anticipate submitting at least one more application in this regard for external funding this year. We're continuing our scientific collaboration with Leiden University Medical Center to further study the mechanism of action of PAL3C inhibitors in a consortium partnership with our company. The innovative research project under a $500 million grant to the Leiden University Medical Center with Acurex as its consortium partner is studying three-dimensional structures of DNA polymerases. and their binding interaction with Acorex inhibitors. The antibacterial molecular target of Acorex's pipeline of novel DNA Pol3C inhibitors has been clinically validated by Avesa Polestat's recent completion of its Phase 2A trial in CDI. The research outcome at Leiden University Medical Center is intended to accelerate lead product candidate selection for our ACX375C program for systemic treatment against multidrug-resistant gram-positive bacteria where new classes of antibiotics are urgently needed. This project was initiated by Leiden University Medical Center in September 2021, and emerging data are expected to facilitate the 375 program. Now I'll turn the call back to our CFO, Rob Shaila, to guide you through the highlights of our financial results for the first quarter of 22. Rob?