Acurx Pharmaceuticals, Inc.

Greetings and welcome to the Acurex Pharmaceuticals second quarter 2021 conference call. At this time, all participants are in a listen-only mode. A 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 Shawa, Chief Financial Officer. Thank you. You may begin.

Thank you. Good morning and welcome to the Acorex Pharmaceuticals second quarter 2021 financial results conference call. Yesterday, we issued a press release providing financial results and company highlights for the second quarter of fiscal and calendar year 2021. This press release is available on our website at acorexpharma.com. Joining me on the call today is David Lucci, President and Chief Executive Officer of Acorex, who will provide a corporate update and outlook for 2021. Following his comments, I will provide an overview of the financial highlights from the quarter and six months ended June 30th, before turning the call back over to David for closing remarks. As a reminder, during today's call, we will 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 certainties 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 10Q, which we filed on Friday, August 13th. Your caution 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. In addition, this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 17, 2021. 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 will now turn the call over to David.

Thanks, Rob. Good morning, everyone, and thank you for joining us on this morning's conference call to discuss AccurX's financial results. During today's call, we'll review our financial results for the quarter and six months ended June 30, 2021, as well as some key corporate highlights, and then we'd be pleased to take any questions. The second quarter of 2021 was a critical quarter in the ongoing corporate development of AccurX. In June 2021, we closed our initial public offering of common stock for gross proceeds of $17.25 million, which included the exercise of the underwriter's entire over-allotment options simultaneously with the closing. We also began trading on the NASDAQ with the symbol ACXP. With the closing of the IPO, we now have financial resources to start and finish our Phase 2B clinical trial of ibezopulstat, our lead drug, in patients with C. difficile infection. as well as to allocate significant resources to continue the development of ACX375C, our second DNA polymerase 3C inhibitor that is at the lead optimization stage of preclinical development. Our scientific team is now working on the logistical aspects of supporting our initial seven clinical trial sites, as well as adding potential new trial sites with the goal to add sites as necessary to ensure completion of enrollment as early as the first half of 2022. At the World Microbe Forum virtual conference in June 21, Dr. Kevin Geary, professor and chair, University of Houston College of Pharmacy and principal investigator for microbiome aspects of our Ibezopolstat clinical program, presented newly available data on the anti-recurrence mechanism of Ibezopolstat in a scientific poster presentation. Data from our phase one healthy volunteer trial showed beneficial changes that are potentially predictive of lower risk of C. difficile occurrence associated with Ibezopolstat compared to the standard of care vancomycin. According to Dr. Gary, and I quote, Ibezopolstat's unique spectrum of activity targeting low guanine cytosine gram-positive bacteria which includes C. difficile, spares important actinobacteria while at the same time killing C. difficile but not killing other firmicutes necessary for maintaining a healthy microbiome. Having such potentially predictive data so early in development could create a new paradigm for C. difficile drug development. After the close of the second quarter, we announced that Health Holland has agreed to fund a research program to further characterize the DNA polymerase 3C enzyme. We announced this innovative research grant in August and are working with the University of Leiden Medical Center in Holland to launch this two-year project in the third quarter of 2021. Also in the second quarter of 2021, we added two key advisors to our team. Joining our scientific advisory board is Dr. Mark Goldberger, the former director of the Office of antimicrobial products at the U.S. Food and Drug Administration. And joining us as a corporate advisor is Fred Hassan, currently a director at Warburg Pincus and previous chairman and CEO, Shearing Plow and Pharmacia. Regarding our patent estate, we continue to aggressively pursue patent protection for our two antibiotic candidates to supplement the regulatory exclusivity that we have on Ibezopulse, our lead drug, from FDA Qualified Infectious Disease product designation and new chemical entity status. In the second quarter of 2021, we also submitted a patent application for the use of ibezopolstat to treat C. difficile infection while improving the health of the gut microbiome. We are particularly excited about the dual impact of ibezopolstat to treat the acute infection, the C. difficile, while appropriately managing the long-term care of the microbiome, which we believe is exceptional for antibiotic therapy. We also secured a patent on our second antibiotic candidate, ACX375C, that includes claims for composition of matter formulation and method of use and extends out to December 2039. In the second half of 2021, we will also participate in a number of healthcare and scientific conferences highlighting our programs and announcing new scientific data as it becomes available. I'll now turn the call back over to Robert Schala, our Chief Financial Officer, to guide you through the highlights of our financial results for the second quarter. Rob?