Veru Inc.

Good morning, ladies and gentlemen, and welcome to Veru, Inc.' 's investor conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the start 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'd now like to turn the conference call over to Mr. Sam Fish, Veru, Inc.' 's Executive Director of 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 10Q and 10K 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, Veru 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 Chief Financial Officer and CAO, Michael Purvis, Executive VP, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Vero 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, Entadfi, 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 multi-billion dollar premium market opportunities. This morning, We will provide an update on the COVID-19 Subisibulin 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 third quarter of fiscal year 2022. First, I will update you on the status of our investigational drug candidate Subisibulin for the treatment of hospitalized COVID-19 patients at high risk for ARDS. We conducted a successful phase 3 COVID-19 clinical trial, which was a double-blind, multi-center, multinational, randomized 2-to-1 placebo-controlled study, evaluating daily oral 9-milligram dose of subizobulin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients who were at high risk for ARDS and death. Both the placebo and subizobulin 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 infection patients are those who were hospitalized and required supplemental oxygen with at least one comorbidity, non-invasive ventilation force oxygen, or mechanical ventilation. Furthermore, patients must have had a peripheral capillary oxygen saturation less than or equal to 94% at room air and hospital admissions. The goal was to select patients at high risk for progression to ARDS and death. The primary endpoint was the proportion of patients who die on study up to day 60, not to day 29 like the other phase three clinical studies reported in the literature. Having a primary endpoint at day 60 allowed us to capture a more accurate and potentially greater number of deaths caused by COVID-19 infection. Key secondary endpoints measured included the proportion of patients without respiratory failure, days in the ICU, days on mechanical ventilation, days in the hospital, and viral load. The study was conducted in the US, Brazil, Argentina, Mexico, Colombia, and Bulgaria. And the COVID-19 infections in the study included both the Delta and Omicron variants. 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 clinical data, the Independent Data Monitoring Committee unanimously recommended that the Phase III study be halted early due to clear clinical efficacy benefit. The IDMC also remarked that no safety concerns were identified. In this interim analysis, subisobulin treatment demonstrated a statistically significant 24.9 percentage point absolute reduction and a 55.2% relative reduction in all-cause mortality by day 60, which is the primary endpoint to the study, with an odds ratio of 3.23, 95% confidence interval of 1.45 to 7.22, with a p-value equals 0.0042. The beneficial effects of subizobulin, were observed starting as early as day 3 after dosing. And by day 15, statistically significant reductions in mortality were observed. The beneficial effects of subizobulin treatment on mortality were maintained through day 29, a standard time point for other studies that other studies have used as the efficacy endpoint, with a mortality rate of 35.2% for placebo compared with 16% for subizobulin, which is an absolute reduction of 19.2 percentage points and a relative reduction of 54.5 percent. From day 29 to day 60, the death rate increased by 9.9 percentage points in the placebo group, and by only 4.2 percentage points in the subisobulin-treated group, showing that the mortality benefit of subisobulin was still clinically evident. This efficacy is further supported by the consistency of the mortality benefit across subgroup analyses of the primary endpoint. Clinically meaningful reductions in deaths with subisobulin treatment compared to placebo was observed regardless of standard of care treatment received, baseline WHO ordinal score, sex, age, baseline comorbidities, BMI, or geographic location. In the full overall final data set of 204 randomized patients, the all-cause mortality benefit was similar to the result observed in the interim efficacy analysis population with subisobulin treatment resulting in a 51.6% relative reduction in deaths compared to placebo treatment. In both the interim analysis efficacy and the overall 204 patient study groups, the key secondary efficacy endpoints demonstrated that subisobulin treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared with placebo. Subisobulin had an acceptable safety profile, Significantly fewer adverse and serious adverse events were reported for subizobulin compared to placebo. There were also fewer treatment discontinuations due to adverse events in the subizobulin group compared to placebo. The Phase III reported safety profiles suggest that subizobulin treatment may have resulted in fewer COVID-19-related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock, and hypotension. The Phase III clinical trial interim efficacy and full study safety results were recently published in the New England Journal of Medicine and Evidence online on July 6, 2022. We're now completing the final clinical study report for the overall study of 204 randomized subjects, and we plan to submit a manuscript of the full data set to a major peer-reviewed medical journal soon. On May 10, we had a pre-emergency use authorization meeting with FDA to discuss the next steps, including the submission of an emergency use authorization application. We were told by FDA to submit the request for EUA. On June 6, we submitted a request for EUA to FDA. As you know, there is no preset PDUFA date to have a decision on a request for an EUA. We know FDA is actively reviewing the application. We have received and have responded to several requests for additional information to help their ongoing review. FDA has conducted a successful pre-approval inspection of one of our manufacturing facilities. FDA has also already audited two U.S. clinical sites with no adverse findings and has scheduled audits of a clinical site in Bulgaria and one in Brazil, which should both be completed by the end of August. FDA has informed us that our request for an EU application is a high priority. Other major regulatory updates. On July 25th, we announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency, the MHRA, considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the companies to vis-a-vis treatment in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome when the application is submitted. On July 27th, we announced that the European Medicines Agency, EMA, Emergency Task Force, has informed the company that has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients and high-risk acute respiratory distress syndrome. The Emergency Task Force's formal press release stated, quote, the review will look at all available data, including data from a study involving hospitalized patients with moderate to severe COVID-19 who are at high risk for acute respiratory distress, syndrome, and death. The results of this study, which is the New England Journal of Medicine evidence publication, would indicate that subisobulin treatment reduces the number of deaths in these patients compared with placebo." The review will assist the EU member states who may consider allowing use of the medicine before possible approval. The review is the first This review is the first to be triggered under Article 18 of the new EU regulation that expanded the role of the EMA during public health emergencies. Not only have we subsequently submitted an application, but we also have had active discussions with the emergency task force. We are also in various stages of discussion with regulatory agencies in other countries to obtain regulatory emergency or expedited authorization for subisibulin. Furthermore, we have made great progress in our discussions for advanced purchase agreements with government officials outside the U.S. As for the commercial manufacturing status for Subisibulin drug product, we have scaled up manufacturing processes and should be able to produce commercial drug supply to address the anticipated drug needs following a potential FDA authorization in the U.S. and potential subsequent authorizations and approvals in other countries and territories. With Subisibulin U.S. commercial update, we have hired Joel Batten as Executive Vice President, the General Manager of VIRU's U.S. infectious disease franchise, effective May 23, 2022. And most recently, Mr. Batten has been the head of the respiratory syncytial virus RSV franchise at Sobe North America, where he was responsible for the Synergist business with revenue of approximately $600 million and a team of over 160 employees. Mr. Batten led strategy for the RSV franchise, as well as market access, distribution, and patient access services. Prior to Sobe, he spent approximately 20 years in a number of positions of increasing responsibility at AstraZeneca, Metamune, and Sanofi Adventis in the virus and infectious disease franchises, including commercial infrastructure build-out, sales management, marketing, public health sales, and government affairs. He has put the core US infectious disease commercial leadership in place. We have contracts executed for the commercial launch teams, market access, medical affairs, and distribution services for subisobulin. We are ready for a launch of subisobulin to hospitals if we're granted emergency use authorization. We recently presented scientific results in the phase three subisobulin clinical program at the International Conference on Emerging Infectious Diseases 2022 in August 8th in Atlanta, Georgia. The presenter was Dr. Michael Gordon, who's Chief Medical Officer at Honor Health Research Innovation Institute, Scottsdale, Arizona. So here we are. COVID-19 global cases, hospitalization, and deaths on the rise again with an unexpected summer surge. The emergence of serious COVID-19 variants, BA.4 and BA.5, have led to this new surge. and these mutated strains have the ability to infect vaccinated patients. The White House warns that they expect over 100 million new cases in the fall and winter. Over one million Americans have died from COVID-19. We must reduce the risk of death from COVID-19. Vaccines are not enough. Antivirals, Paxilovir and Molnupiravir target the non-hospital general population who have experienced less than five days of symptoms with a narrow therapeutic window of opportunity. Paxilobin cannot prevent COVID-19 infections and is not effective in low-risk populations. Antivirals like molnupiravir do not work in hospitalized moderate to severe COVID-19 patients. U.S. deaths from COVID-19 are now averaging 500 deaths a day, and these patients are dying in the hospital. The death rate is unacceptable. It is clear that an effective and safe oral therapeutic to treat hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS that prevents death is desperately needed. We strongly believe that subizobulin, with its dual antiviral and anti-inflammatory properties, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients as the new standard of care. We plan to initiate additional clinical studies to evaluate subizobulin treatment in other populations at risk for death, from COVID-19 infection, and as a treatment for 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, which causes 14,000 deaths and 177,000 hospitalizations each year in the U.S. These additional clinical studies that are successful will allow us to expand subisobulin to other large, serious infectious disease indications. Some of these planned clinical trials include a Phase III randomized placebo-controlled efficacy and safety study of subisobulin for the treatment of severe – for the treatment of COVID-19 hospitalized patients who are WHO3s, which means they're in the hospital, in trouble, but not on oxygen, and also the WHO4s without the presence of a comorbidity. And so that allows us to approach the other 50% of patients that are hospitalized. Phase three, the other trial was a phase three randomized placebo-controlled efficacy and safety study of sebizobulin for the treatment of hospitalized patients with acute respiratory distress syndrome due to any viral illness. I will now briefly discuss the progress of our oncology drug portfolio that's focused on breast and prostate cancers. For patients with greater than or equal to 40% AR expression, we're actively enrolling a global phase 3 R test registration clinical trial in approximately 210 patients who evaluate a Novosarm monotherapy for third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. We've also moved the Novosarm therapy earlier in the treatment sequence into second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancers. We are actively enrolling in a phase three multi-center, open-label, randomized, active control registration, enabler two clinical study to evaluate the efficacy and safety for Novosarm and abemacyclib, a combination therapy, versus an alternative estrogen-blocking agent in subjects with ER-positive HER2-negative metastatic breast cancer who have failed first-line therapy with pavlocyclib, which is 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 have a clinical trial collaboration and supply agreement with Lilly for this Enabler II Phase III clinical study. Under the terms of the non-exclusive clinical trial collaboration and supply agreement, Bureau is responsible for conducting the clinical trial while Lilly is supplying a venocyclic for the study. VIRU maintains full exclusive global rights to Inovacine. We've also made good progress in our prostate cancer program. Our first indication is evaluating sabizabulin for third-line treatment of metastatic castration-resistant prostate cancer in the Phase III veracity study. We have recently published in Clinical Cancer Research the clinical results of the positive Phase Ib2 study Subitabulin in 80 men with metastatic castration-resistant prostate cancer have progressed on at least one novel angio-receptor-targeted agent. The summary of the results published was that the maximal tolerated dose was not reached in the Phase 1b, and the recommended Phase 2 dose was set at 63 milligrams a day. The most common adverse events, which is greater than 10% frequency at the 63 milligram oral daily dosing in the combined Phase 1b2 data, were predominantly grade 1-2 events. Greater than three events included diarrhea at 7.4%, fatigue at 5.6%, and alanine aminotransferase and aspartate aminotransferase elevations of 5.6% and 3.7% respectively. Neurotoxicity and neutropenia were not observed. Preliminary efficacy clinical data in patients treated with greater than one continuous cycle of 63 mg or higher included an objective response rate and 6 of 29, or 20.7%, of patients with measurable disease, which is one complete and five partial responses, and 14 of the 48, or 29.2% of the patients, had PSA declines. Most importantly, the Kaplan-Meier median radiographic progression-free survival was estimated to be 11.4 months with an N of 55 patients, and we had durable responses lasting greater than 2.75 years. These data support the ongoing Phase III veracity trial of subisobulin in men with metastatic castration-resistant prostate cancer. So we're actively enrolling an open-label, randomized two-to-one, multi-center Phase III veracity clinical study evaluating subisobulin 32 milligrams versus an alternative enzyme receptor targeted agent for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer who have had tumor... tumor progression after previously receiving at least one androgen receptor-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 in 45 clinical centers in the U.S. Our second clinical study in prostate cancer is evaluating VIRU100, a GnRH antagonist three-month depot formulation in a Phase II dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Although this study is ongoing, the preliminary clinical data continues to be promising. As you can see, we have an exciting and treatment paradigm-changing late clinical stage oncology portfolio of drug candidates making great progress in advanced breast and prostate cancers. Bureau has a commercial sexual health division called UREV which includes two FDA-approved products, FC2 for the dual protection against unplanned pregnancy and transmission of sexual transmitted infections, and the FDA-approved Entatfi, tadalafil and finasteride capsule, a new treatment for benign prostatic hyperplasia, also known as BPH. We have built the infrastructure to allow broad market access to FC2 across the U.S. As a result, FC2 is now available through multiple sales channels. We have partnered with fast-growing, highly reputable telemedicine platform companies to bring our FC2 product to patients in a cost-effective and highly convenient manner. Our strategy to continue to drive FC2 sales is as follows. One, we will seek additional telemedicine internet pharmacy service partners. Two, we created and launched our own dedicated direct-to-patient telemedicine internet pharmacy services platform. This telemedicine platform is now up and running and is expected to be a new source of revenue. The website address is fc2condoms.com. Three, we've increased U.S. public sector sales by our new agreements with distribution partnerships with Global Protection as well as F-AXIS. We also have Intanfi, an FDA-approved new treatment for benign prostatic hyperplasia. The most common side effects of currently prescribed FBPH medicines are sexual adverse events, including impotence. Entafi has been shown to be faster and more effective for the treatment of benign prostatic hyperplasia than finasteride alone without causing impotence. I'm happy to report that we have officially launched Entafi, and the product is available for pharmacies to dispense. We have partnered with GoodRx, a U.S.-based digital resource for healthcare, to reach their almost 20 million monthly visitors, which includes both consumers and healthcare providers, to build awareness about Entafi. There are over 45 million prescriptions filled annually for drugs that treat BPH. We plan to augment our own marketing and sales efforts by seeking additional partners in the U.S. and ex-U.S. I will now turn the call over to Michelle Greco, CFO and CAO, to discuss the financial highlights. Michelle?