Acurx Pharmaceuticals, Inc.

Good greetings and welcome to the Acryx Pharmaceuticals first 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, Rob Shawah, Chief Financial Officer. Thank you, sir. You may begin.

Thank you. Good morning. Welcome to our call. This morning, we issued a press release providing financial results and company highlights for the first 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 and outlook for 2023. After that, I'll provide some highlights. The financials for the quarter ended March 31, and then turn the call back 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 today, Friday, May 12, 2023. You are questioned not to place undue reliance on these forward-looking statements and Accorex 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 12th, 2023. Accorex 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 first quarter of 23 and to cover some recent updates. Then we'd be pleased to take any questions. In the first quarter, we continue to enroll more patients in our Phase 2B clinical trial of our oral Ivesapolstat, our lead antibiotic candidate for the treatment of patients with C. difficile infection. The 2B trial is a randomized, one-to-one, non-inferiority, double-blind trial of oral ibezoplastab compared to oral vancomycin, the standard of care to treat C. difficile infection. The primary endpoint is clinical cure at the end of treatment, and a secondary endpoint is sustained clinical cure measured at the day 38 follow-up visit. Since this is a double-blind trial, results won't be known until the end of the trial. However, operationally, the trial is proceeding as expected with no safety signals reported to date. and the blinded observed data has been exceptional. The Phase IIb Trial Protocol includes an exploratory endpoint comparing the impact on the microbiome between our Ibezopolstat and Vanco. In the event non-inferiority of Ibezopolstat to Vanco is demonstrated, further analysis will be conducted to test for superiority. Due to slower enrollment than expected during COVID-19 and its aftermath, We expanded the number of clinical trial sites participating in the 2B trial from the initial 12 sites to now we have a total of 28 trial sites. Most importantly, in March 2023, the FDA accepted our protocol amendment to our IND, which will allow an independent data monitoring committee, which we've assembled, to review interim clinical data upon reaching 36 patients enrolled and then to provide its recommendation either to early terminate the 2B trial, as we had done with the 2A trial, you may recall, or alternatively, continue enrolling. We anticipate completing enrollment of the 36 patients in the second half of 23. The company intends to report available data promptly after the IDMC conducts this interim review. The company has, we remain particularly excited about the dual impact of Ibezopulstat to treat 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 first quarter of 23, or in some cases shortly thereafter, include the following. In April 23, two presentations were made at the 33rd Annual ECMIT Conference in Copenhagen, Denmark. first a scientific poster entitled Novel Pharmacology and Susceptibility of Abezopulstat against C. difficile isolates with reduced susceptibility to C. difficile-directed antibiotics was presented by Dr. Kevin Geary, Professor and Chair of University of Houston College of Pharmacy and Principal Investigator for Microbiome Aspects of our Abezopulstat Clinical Trial Program. Dr. Geary's work demonstrated that Abezopulstat's mechanism of action is not only bactericidal to C. diff, but also inhibits some of its virulence mechanisms, meaning its capability to cause disease. Dr. Gary also noted that C. difficile strains with reduced susceptibility to metronidazole, vanco, and fidaxomycin were in fact susceptible to Ibezopolstat. Ibezopolstat's antivirulence 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. The second of the two ECMID presentations was by our chairman, our executive chairman, Bob DeLuccia, who presented an update regarding the company's preclinical systemic oral and IV program for treatment of other gram-positive infections caused by MRSA, VRE, and DRSP at the Pipeline Corner featured session at ECMID. organized by Dr. Ursula Teresbacher, a world-renowned microbiology expert in antibacterial research. Following the clinical validation of the PAL3C bacterial target in our Phase IIa trial, showing 100% cures with no reinfections, we've made significant improvements in cytotoxicity, solubility, and protein binding. and in vivo safety and have demonstrated oral and IV efficacy in a number of mouse infection models. Both the poster and the presentation are available on our website. Additionally, we wanted to mention Dutch sponsorship. The company is continuing its R&D collaboration with Leiden University Medical Center in Holland under a previously awarded grant from the Dutch government of approximately a half million dollars to further evaluate the mechanism of action of our inhibitors against the DNA-PAL3C enzyme, which is the bacterial target of our antibiotic pipeline for the systemic treatment, IV and oral, of gram-positive bacterial infections. Data generated from this program was critical to include in a recent non-dilutive grant application to CARB-X, which I'll describe in more detail in a moment. But based on this successful collaboration, were hoping to receive an additional two-year grant for more research in this regard, which if it comes through, we're expecting in the middle of the year, and it would be in the range of $800,000 for this second component. Let's now turn to CARB-X. We remain in the running for funding our second antibiotic candidate, targeting the treatment of MRSA infections by CARB-X, and we expect the final decision no later than October of this year. Just to reflect on how this came about, in October of 22, we applied to CARB-X for a non-dilutive grant of up to $11.3 million, which, if approved, would provide funding for our second antibiotic program targeting MRSA infections for a period of five years up to the start of Phase II clinical trials. CARB-X recently informed us that our application is in the active review pool, and a final decision is to be rendered by CARB-X no later than October 23. We believe that based on our recent development progress and the unique nature of having a new class of antibiotics, together with our understanding that CARB-X already made final decisions on most candidates. We remain under active review. For these reasons, we believe we have a strong possibility to gain CARB-X approval for funding later in the year. If approved, CARB-X would fund the $11.3 million of a $16 million project, and that would cover oral and IV formulations of our second antibiotic candidate, ACX-375. Now, just looking ahead a bit, the AMR Congress, later this year in September, the World Antimicrobial Resistance Congress will convene its annual meeting in Philadelphia, where experts in the field from both public and private sectors weigh in on the latest innovations to address AMR. Our Executive Chairman, Bob DeLuccia, was invited to and will speak at the Innovative Showcase section of the conference and will present an update entitled, Novel DNA PAL3C Inhibitors for gram-positive bacterial infections, preparing for the next pandemic. After the presentation, it will be available on our website. Also looking ahead a bit, we'd like to mention the Pasteur Act. Last month, U.S. Senators Michael Bennett from Colorado and Todd Young reintroduced the Pasteur Act, pioneering antimicrobial subscriptions to end up surging resistance. to encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability of antibiotics when needed. According to Senator Bennett, the bipartisan Pasteur Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. If approved, Pasteur has the potential to enhance the commercial prospects for our antibiotics by providing funding for our Phase III clinical trials and stockpiling our antibiotics at public health facilities in the U.S. each year for 5 to 10 years. As currently drafted, designation as a critical need antimicrobial under the Pasteur Act, if approved, would apply to sponsors of antibiotic candidates which are a new class of antibiotics and that target the treatment of serious or life-threatening infections, as is the case with our lead antibiotic candidate, Dr. Polstad. Accordingly, we're quite enthusiastic about the prospects of the Pasteur Act being passed into law. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the quarter. Rob?