Veru Inc.

Good morning, ladies and gentlemen, and welcome to Vero Incorporated's investor conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fish, Barrow Incorporated's Executive Director, Investor Relations and Corporate Communications. Please go ahead.

Good morning. The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or development to differ materially are contained in our 10-Q and our 10-K SEC filings, as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Vero, Inc.' 's Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, the Chief Scientific Officer, Michelle Greco, the CFO and CAO, Michael Purvis, EVP, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Vera is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancers. The company has a commercial sexual health division called UREV, which includes two FDA-approved products and Tadfi, a new treatment for benign prostatic hyperplasia, and the FC2 female condom, internal condom, for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The revenue from the sexual health division is being used to largely fund the clinical development of our late-stage drug candidate assets, which aim to address multibillion-dollar premium market opportunities. This morning, we will provide an update on the COVID-19 Subicibulin clinical program and franchise, the clinical development of our oncology drug pipeline, and the commercialization of our products. We will also provide financial highlights for our second quarter fiscal year 2022. While there have been recent emergency use authorizations for antiviral drugs, molnupiravir from Merck and Paxilovir from Pfizer, for the treatment of unhospitalized patients with COVID-19, with less than five days of symptoms, who are at relatively lower risk of dying. Sibizabulin, in contrast, is being developed for hospitalized moderate to severe COVID-19 patients who are at high risk of acute respiratory distress syndrome and death, patients for whom there is currently no clearly effective treatment, and the population which molnupiravir, the antiviral agent for Merck, did not demonstrate efficacy. Subisibulin disrupts intracellular transport of coronaviruses along the microtubules. This is a highly conserved biologic process that's required by all variants of COVID-19, including Omicron, to cause infection. We conducted a Phase III COVID-19 clinical trial, which was a double-blind, multicenter, multinational, randomized 2-to-1 placebo-controlled study evaluating daily oral 9-milligram dose of subisibulin for up to 21 days versus placebo, in approximately 210 hospitalized moderate to severe COVID-19 patients who had high risk for ARDS and death. Both the placebo and subisobulin treated groups were allowed to receive standard of care, which could include dexamethasone, remdesivir, anti-IL-6 receptor antibodies, and JAK inhibitors. Moderate to severe COVID-19 symptoms in this study means patients that were hospitalized and required supplemental oxygen, forced oxygen, or mechanical ventilation. Furthermore, one of the inclusion criteria is that patients must have a peripheral capillary oxygen saturation of less than or equal to 94% on room air. This is a very sick patient population and high risk for ARDS and death. The prespecified primary efficacy endpoint is the proportion of patients who die on study up to day 60, not up to day 29 like other studies reported in literature. Our day 60 endpoint allowed us to capture a more accurate number of deaths caused by COVID-19 infection. Secondary endpoints included the proportion of patients without respiratory failure, days in the ICU, WHO ordinal scale for clinical improvement change from baseline, days of mechanical ventilation, days in the hospital, and viral load. The study was conducted in the United States, Brazil, Argentina, Mexico, Colombia, and Bulgaria, and COVID-19 infections in the study included the Delta and Omicron variants. In January of 2022, the FDA granted fast-track designation to the Phase III COVID-19 registration program. Fast-track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy with nonexistence of providing a therapy which may be potentially better than an available therapy. Thus, having fast track is a distinction that underscores the urgent need for new, novel, and effective therapies to be used alongside with vaccines to combat this COVID-19 pandemic. On April 8, 2022, the Independent Data Monitoring Committee conducted a planned interim analysis in the first 150 subjects randomized in the Phase III COVID-19 study After reviewing the unblinded data, the Independent Data Safety Monitoring Committee unanimously recommended that the Phase III study be halted early due to overwhelming efficacy. They also remarked that no safety concerns were identified. The pre-specified primary endpoint was death at or before Day 60. Subisibulin treatment resulted in a clinically and statistically meaningful 55.2% relative reduction in death P-value equals 0.0043 in the intent-to-treat population. Placebo group, N equals 52, had a 45% mortality rate compared to the 20% mortality rate in the subisobulin-treated group, N equals 98. At day 29, the death rate in the placebo group in our study was 35%, which is the same death rate as reported in the Lancet publication in May 2020 to 2021 for the placebo group of a similar hospitalized patient group consisting of 2,094 patients for the tocilizumab recovery study. Furthermore, one could expect the death rate in the placebo group at day 60 to be higher than day 29 death rate. The placebo group at day 60 death rate of 45% in our study underscores how sick these patients really were. Patients in the Phase III COVID-19 study were allowed to receive standard of care, which was balanced between the subisobulin and placebo groups, with approximately 80% receiving dexamethasone and about 30% receiving remdesivir. Thus, high death rates in the placebo group demonstrate the inadequacy of the current standard of care. We plan to publish the secondary efficacy endpoints in a peer-reviewed medical journal as soon as practical. Subvisivulin treatment was well tolerated in this patient population with no clinically relevant safety observations in the subvisivulin treated group compared to placebo. We had a pre-emergency use authorization meeting with FDA on May 10th to discuss the next steps, including the submission of an emergency use authorization application. The outcome of this meeting is as follows. FDA agreed. that no additional efficacy studies are required to support an EUA or a full NDA. FDA agreed that no additional safety data are required to support an EUA and collection of safety data under the EUA will satisfy the safety requirement for a full NDA. Therefore, FDA agreed that the request for EUA is supported by efficacy and safety data from our positive phase three COVID-19 study and hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS, and no additional clinical studies are required to support an NDA submission. We plan to submit the EUA application in this quarter. Furthermore, we have scaled up manufacturing processes to produce commercial drug supply to address the anticipated drug needs following a potential FDA authorization in the U.S. and a potential subsequent authorization in other countries and territories. We're also making progress building out our own U.S. commercial infectious disease franchise. We are actively seeking an advanced purchase agreement with the U.S. government. In fact, we're meeting with government officials. Usually, an advanced purchase agreement is awarded after emergency use authorization is received. We're also moving forward to submit regulatory applications to the MHRA in Britain and to the COVID-19 European Medicines Agency Pandemic Task Force for the European Union as well as other countries. We're in discussions with numerous potential distribution partners. COVID-19 global cases, hospitalizations, and deaths are on the rise again. We have reached a sad milestone. Over 1 million Americans have died from COVID-19. We must reduce the risk of death from COVID-19. New variants of COVID-19 are brewing. COVID-19 surges will happen. Vaccines are not enough. And some of the antibody drugs are not effective against Omicron variant BA1 or BA2. And as I already pointed out, antivirals, Paxilovir, and Monopiravir target the pre-hospital general population who've experienced less than five days of symptoms, a narrow window of opportunity. It's clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 infection who are at high risk for ARDS and death is desperately needed. We strongly believe that sabizabulin, with its dual antiviral and anti-inflammatory properties, can be that greatly needed oral therapy for the hospitalized moderate to severe COVID-19 patients as a new standard of care. We will continue to update you on the regulatory progress towards EUA in the U.S. and other countries, manufacturing, additional clinical data release and publications, BARDA and other government agency discussions, U.S. and global distribution plans, and partnership discussions. Furthermore, Given these exceptional clinical efficacy and safety results, we plan to initiate new clinical studies against other viruses that cause ARDS, including influenza A virus, which causes up to 52,000 deaths and 710,000 hospitalizations each year, and respiratory syncytial virus, also known as RSV, which causes 14,000 deaths and 177,000 hospitalizations each year in the United States. These new clinical studies will allow us to expand sabizabulin to other large, serious infectious disease indications. I will briefly discuss the progress of our oncology drug portfolio focused on breast and prostate cancers. For patients with greater than or equal to 40% AR expression, we are actively enrolling a global phase three R-test registration clinical study in approximately 210 patients to evaluate Inovasar monotherapy for the third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. In January of 2022, FDA granted fast-track designation to our Phase III R-test registration program. We're also moving in Novosong therapy earlier in the treatment sequence into the second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancer. We are actively enrolling in the Phase III multicenter open-label randomized one-to-one active control registration program enable a two-clinical study to evaluate the efficacy and safety of anobisarm and abemiciclib combination therapy versus an alternative estrogen-blocking agent in subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer who have failed first-line therapy with palpociclib, a CDK4-6 inhibitor, plus an estrogen-blocking agent who have greater than or equal to 40% AR expression in their breast cancer tissue. We plan to enroll approximately 186 subjects in this Phase III clinical study. We recently announced that we've entered into a clinical trial collaboration and supply agreement with Lilly for the Enabler 2 clinical, Enabler 2 Phase 3 clinical study. And under the terms of the non-exclusive clinical trial collaboration and supply agreement, Vera is responsible for conducting the clinical trial, while Lilly will supply a bemacite cyclib for the study. Vera maintains full exclusive global rights to Inova's arm. We've also made great progress in our prostate cancer programs. Our first indication is evaluating subisobulin for the third-line treatment of metastatic castration-resistant prostate cancer in the VERACITY Phase III study. We will be presenting final clinical data from the positive Phase Ib2 study of subisobulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel antireceptive-targeted agent at the ASCO conference being held in June of 2022 in Chicago, Illinois. We are actively enrolling in open-label, randomized 2-to-1 multicenter Phase III veracity clinical study evaluating subisobulin 32 milligrams versus an alternative antireceptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castrate-resistant prostate cancer who have had tumor progression after previously receiving at least one antireceptor-targeted agent. The primary endpoint is radiographic progression-free survival. Enrollment for the Phase III veracity clinical study is on track, and we expect to enroll approximately 245 patients from 45 clinical centers in the U.S. Our second clinical study in prostate cancer is evaluating Vero100, a GnRH antagonist three-month depo formulation, in a Phase II dose-vinding clinical study for the treatment of hormone-sensitive advanced prostate cancer. We're conducting the Phase 2 dose-finding clinical study of VIR-100, androgen deprivation therapy in 45 men with hormone-sensitive advanced prostate cancer. Although this study is ongoing, the preliminary clinical data are promising. The Phase 3 registration clinical study design has already been agreed upon with FDA. It will be a single-arm study, which will involve approximately 100 men. Maintenance of castrate blood concentrations of testosterone is the primary endpoint. And after the Phase 2 dose-finding study is completed, we will initiate the Phase 3 clinical study. The Bureau has a commercial sexual health division called UREV, which includes two FDA-approved products, the FC2 for the dual protection against unplanned pregnancy and transmission of sexual transmitted infections, and the recently FDA-approved Intafi, which is Tadalafil finasteride capsule, and new treatment for benign prostatic hyperplasia. We have built the infrastructure to allow for broad market access to FC2 across the U.S. As a result, FC2 is now available through multiple sales channels. In particular, we have partnered with fast-growing, highly reputable telemedicine platform companies to bring our FC2 product to patients in a cost-effective, highly convenient manner. A strategy to continue to drive robust FC2 sales is not only to seek additional telemedicine and internet pharmacy service partners, but also to create our own direct-to-patient telemedicine and internet pharmacy services platform. This telemedicine platform is now up and running and is expected to be a new source of revenue. We've also developed Entadfi, a new treatment for BPH. The most common side effects of currently prescribed BPH medicines are sexual adverse events, including impotence. Entadfi has been shown to be more effective for the treatment of BPH than Finasteride alone, without causing impotence. Intafi was approved by FDA in December of 2021. The plan is to officially launch Intafi next quarter. We are waiting for the FDA to sign off on the manufacturing release criteria for the Intafi commercial product. Intafi is expected to be marketed and distributed by a third-party direct-to-patient telemedicine and internet pharmacy services platform partnership. We have also partnered with GoodRx. a U.S.-based digital resource for healthcare, to reach their almost 20 million monthly visitors, which include both consumers and healthcare providers, to build awareness about INTASFI. There are over 45 million prescriptions filled annually for drugs to treat BPH. We plan to augment our marketing and sales efforts by seeking additional partners in the U.S. and ex-U.S. I will now turn to call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?