Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals fourth quarter and full year 2022 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, Robert Shawah, Chief Financial Officer. Thank you, Robert. You may begin.

Good morning, thank you, and welcome to our call. This morning, we issued a press release providing financial results and company highlights for the fourth quarter and fiscal year 2022. This press release is available on our website at accorexpharmaceuticals.com. Joining me today is Dave Luci, President and CEO of Accorex, who will give a corporate update and outlook for 2023. After that, I'll provide some highlights of the financials from the quarter and the year ended, December 31, 2022, 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. involved 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 Wednesday, March 15, 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, March 16th, 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 Lucci.

Thanks, Rob. Good morning, everyone, and thanks for joining us on this conference call to review our financial results for the fourth quarter and year-ended 12-31-2022. It also covers some recent updates, and then we'd be pleased to take any questions. In the fourth quarter of 2022, we continue to enroll more patients in our Phase IIb clinical trial of Ibezapolstat, our lead antibiotic candidate for the treatment of patients with C. difficile infection, or CDI, as we call it. The Phase IIb clinical trial is a randomized, one-to-one, non-inferiority, double-blind trial of oral ibezopulsac compared to oral vicomisin, a standard of care to treat CDI. The primary endpoint is clinical cure at the end of treatment, and a secondary endpoint is sustained clinical cure measured at 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 Ibezapolstat and the standard of care, vancomycin. In the event non-inferiority of Ibezapolstat to vanco is demonstrated, further analysis will be conducted to test for superiority. As we previously discussed, due to slower-than-expected enrollment during and possible resurgence of COVID-19 infections, we expanded the number of clinical trial sites participating in the Phase IIb trial from the initial 12 sites to a total of 28 trial sites. This project was commenced in July 2022 and completed in the fourth quarter. We remain particularly excited about the dual impact of using ibezopolstat to treat acute CDI while appropriately managing the long-term care of each patient's microbiome, which we believe is exceptional for antibiotic therapy. Details of the impact on the microbiome were presented in oral and poster presentations at ID Week in October 2022 and are available on our website. Most importantly, based on the blind and observed data from the ongoing Phase IIb clinical trial to date, In January 2023, the company filed a protocol amendment to its Investigational New Drug Application, or IND, with the FDA to allow for an Independent Data Monitoring Committee, or IDMC, to review interim clinical data. If acceptable to the FDA, the IDMC will review the clinical data upon enrollment of 36 patients. I repeat, 36 patients, not 64 patients, in the Phase IIb clinical trial. The company currently has enrolled 25 patients in the trial to date. The IDMC will determine and recommend to the company whether the most appropriate course of action forward is to early terminate the 2B trial, as we did previously with our Phase 2A clinical trial, or to continue patient enrollment. The company intends to report available data promptly after the IDMC conducts this interim review. The company assembled its IDMC, Independent Medical Committee, in the first quarter of 2023 solely for this purpose. Other key highlights from the fourth quarter of 2022, or in some cases shortly thereafter, include the following. The company has continued its R&D collaboration with Leiden University Medical Center in Holland to further evaluate the mechanism of action of Acrex's inhibitors against the DNA-PAL3C enzyme, which is the bacterial target of our antibiotic product pipeline for the systemic treatment of other grant-positive bacterial infections. Data generated from this program was critical to include in a recent non-dilutive grant application, which I will describe in more details in a minute. This grant application was submitted by the company in the fourth quarter of 2022. based on this successful collaboration with LUMC has proposed a second stage two-year project to further analyze chemical structure relationships of new Acorex compounds with a propensity for reduced antimicrobial resistance. At this point, this new project proposal is subject to review approval and funding by the Dutch government, but the grant is expected to be for about $500,000 in total, similar to the original grant amount that was provided by the Dutch government for the initial project. The company completed certain portions of its laboratory study at the University of Houston, comparing the killing effect of ibuprofen to vancomycin, fidaxamycin, and metronidazole, using both in vitro and ex vivo analyses. Certain results were presented at the Antirope Society of America Annual Scientific Conference, and results demonstrated that Ipeza-Pulset has favorable killing candidates compared to vancomycin to treat C. difficile infection at standard and high bacterial concentrations, supporting continued development of this first-in-class antibiotic to treat C. disinfection. Comparisons of the killing effect of Ipeza-Pulset to fidaxomycin and metronidazole are ongoing. In October 2022, the company filed for a non-dilutive grant of up to $11.3 million, which, if approved, would provide funding for ACX375, our second antibiotic program targeting the treatment of MRSA infections, for a period of five years of drug development, right to the start of Phase II clinical trials. The company is now in the third and final round of consideration for this non-dilutive grant, and a decision is expected in April 2023, just a few weeks from now. If approved, the company would need to pay approximately $5 million of the total project cost of approximately $16 million in total over a five-year period and the grant would pay the other $11.3 million. Next month, the European Congress of Clinical Microbiology and Infectious Disease, one of the most comprehensive and influential scientific conferences in clinical microbiology and infection, will hold its 33rd session in Copenhagen. An abstract entitled Novel Pharmacology and Susceptibility of Ibezopulstat against C. diff. isolates with reduced susceptibility to C. diff. directed antibiotics has been accepted. Dr. Kevin Gary, Professor and Chair, University of Houston College of Pharmacy, and the Principal Investigator for Microbiome Aspects of our Ivesa-Ploestat Clinical Trial Program will be presenting on our behalf. Additionally, our Executive Chairman, Bob DeLuccia, has been invited to present at the company's Preclinical Systemic Oral and IV Program for treatment of other gram-positive infections caused by MRSA, VRE, and DRSP. and the quote unquote pipeline corner featured session organized by Dr. Ursula Thurisbacher, a world renowned microbiology expert for antibacterial drug research, discovery and development strategies and policies for clinical and public health needs. More details on these presentations will be announced prior to the meeting date. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the fourth quarter and year end 2022. Rob?