Acurx Pharmaceuticals, Inc.

Greetings. Welcome to AccuRx Pharmaceuticals second quarter results and business update. At this time, all participants are in a list 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. Please note this conference is being recorded. I will now turn the conference over to Robert Shawah, CFO. Thank you. You may begin.

Thank you. Good morning and welcome to our call. Yesterday, we issued a press release providing financial results and company highlights for the second quarter of 2022. This press release is available on our website at acrexpharmaceuticals.com. Joining me today is David Luci, President and CEO of Acrex, who 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 June 30th 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 on Friday, August 12, 2022. 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 date of this live broadcast, Today, August 16, 2022. ACREX 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 quarter ended June 30th and also cover some key corporate highlights and then we'd be pleased to take any questions. In the second quarter, we continue to enroll more patients in the Phase 2B clinical trial of Ibezopulstat, our lead antibiotic candidate for the treatment of patients with C. difficile infections or CDI. The Phase 2B clinical trial is a 64-patient randomized one-to-one non-inferiority double-blind trial of oral Ibezopulstat compared to oral vancomycin. a standard of care for the treatment of CDI. The primary endpoint of the Phase 2B clinical trial is clinical cure at the end of treatment, and the 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 recorded to date. The protocol includes an exploratory endpoint comparing the impact on the microbiome between ibuprofen and vancomycin. In the event non-inferiority of ibuprofen to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Additionally, due to slower-than-expected enrollment, we expanded the number of clinical trial sites participating in the Phase IIb trial. from the initial eight U.S. trial sites to up to 30 trial sites. Currently, there are 16 trial sites open for enrollment with an additional eight trial sites currently onboarding at this time. We remain particularly excited about the dual impact of using Ipeza-Pulstat to treat acute CDI 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 2022, or in some cases shortly thereafter, include the following. First, we've completed certain portions of our laboratory study at the University of Houston, comparing the killing effect of ibezopolstat to vancomycin, cadaxamycin, and metronidazole, using both in vitro and ex vivo analyses. Certain results were presented on our behalf by Dr. Eugene Becerras, Professor at University of Houston College of Pharmacy at ANIROBE 2022, the ANIROBE Society of America Annual Scientific Conference. The conclusion from this study, from the data presented to date, analyzed to date, is that Ibezopulsat demonstrated favorable killing kinetics compared to currently marketed antibiotics to treat C. difficile infection at standard and high concentrations. supporting continued development of a potential first-in-class antibiotic to treat C. difficile infection. Secondly, in terms of highlights, Abeza Polstad presentations have also been accepted at three upcoming prominent scientific conferences later this year, including the Antimicrobial Resistance Conference in September, ID Week in October, and the C. diff Foundation Conference in November. Our scientific collaboration with Leiden University Medical Center continues to support our preclinical development program to further study the mechanism of action of PAL3C inhibitors in a consortium partnership with our company. This innovative research project, under a $500,000 grant to Leiden University Medical Center, with Actirect as its consortium partner, is studying three-dimensional structures of DNA polymerases. and their binding interactions with Acorex inhibitors. The antimicrobial molecular target of Acorex's pipeline of novel DNA Pol3C inhibitors has been clinically validated by Ibezapolstat's recent completion of its Phase 2A trial in C. diff infection. The research outcome at Leiden University is intended to accelerate lead product candidate selection for our ACX375 program, our second drug. for systemic treatment against multidrug-resistant gram-positive bacteria where new classes of antibiotics are urgently needed. This project was initiated by Leiden University in September 21, and emerging data are expected to facilitate the 375 program development. Fourth, in July 2022, we launched an innovative patient enrollment acceleration program to optimize patient enrollment in our ongoing 2B trial of imbezopolstat in patients with C. diff. Our newly instituted referring physician program involves principal investigators and study coordinators of our clinical trial sites reaching out to potential referring physicians within an appropriate, an approximate 25 mile radius of our clinical trial sites. In each case, we've identified potential referring physicians as high prescribing physicians of the most commonly used antibiotics for the treatment of C. diff over a recent 12-month period from IMS data. According to the physician prescribing data available to us from an industry standard source, identified referring physicians in the aggregate of just 14, the first 14 of our currently activated trial sites, treated a total of over 30,000 patients in a recent 12-month period. suggesting that a substantial number of subjects could potentially be available for referral to one of the 14 clinical trial sites if the patients qualify. The first tranche of this program has been activated with four of our clinical trial sites and is planned to be followed up later this year with a second tranche as we expand our participating sites from 16 up to 30. We believe the Referring Physician Program, which has a number of other supportive elements, will enhance the rate of enrollment, potentially mitigating or partially mitigating the countervailing enrollment disruption caused by the COVID-19 pandemic. Additionally, to reiterate, in July 2022, we increased the target number of clinical trial sites participating in our Phase 2b trial from a target of 24 sites from last quarter up to 30 sites now, with 16 sites active and eight more onboarding Our scientific team will continue to target six additional trial sites to participate in the 2B clinical trial. Finally, in July 22, the company raised an additional $4.225 million of gross proceeds by consummating a registered direct offering, issuing an aggregate of 1,290,000 shares of common stock, which included about 130,000 pre-funded warrants to purchase shares of our common stock. to one institutional investor at a purchase price of $325 per share, which represents common shares at .001 per share exercise price for the pre-funded warrants, and a price of $380 per share for the company's executives that invested in the offering, three of us in particular. The company has also issued to each investor a Series A unregistered warrant to purchase 1,290,000 shares of our common stock and a Series B warrant to purchase another 1,290,000 shares of our common stock. The B warrant has a one and a half year expiry and has no cashless exercise unless we're not registered with the SEC, which basically means we'll get another $4.2 million in the door, assuming success with the Phase 2B trial. and now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the second quarter of 22. Rob?