Veru Inc.

Good morning, ladies and gentlemen, and welcome to Veru, Inc.' 's investors 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. Veruz Inks, Executive Director, Investor Relations and Corporate Communications. Mr. Fuchs, please go ahead. Good morning.

The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, or they're not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolios. Such forward-looking statements are subject to known and unknown risk 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 developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time. I'd now like to turn the conference call over to Dr. Mitchell Steiner, Vera Williams Chairman, CEO, and President.

Good morning. With me on this morning's call are Michelle Greco, CFO, CAO, Michael Purvis, Executive Vice President, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Vero is dedicated to the development of novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer. One of our anti-cancer drugs, abysmobulins, has dual antiviral and anti-inflammatory effects, so it is also being developed for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, which remains a global dire unmet medical need. The company has a commercial sexual health division called UREV, which includes two FDA-approved products, Intadfi, a new treatment for BPH, which is 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 discuss Bureau's business strategy, the clinical development of our drug pipeline, and the commercialization of our products. We will also provide financial highlights for our first quarter of fiscal year 2022. COVID-19 global cases, hospitalizations, and deaths were at the highest level since the start of the pandemic. Some of the antibody drugs are not effective against the Omicron variant. It is 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 acute respiratory distress syndrome is desperately needed. We strongly believe that subisobulin with its antiviral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized patients with COVID-19. Subisobulin disrupts the intracellular transport of the coronaviruses by microtubules. This is a process that's required by all variants of COVID-19, including Omicron, to cause infection. While there have been recent developments evaluating the Merck drug, Lomipiravir, and the Pfizer drug, Paxlovid, for the treatment of unhospitalized patients with mild to moderate COVID-19 who had a relatively low risk of dying, Sibizabulin, in contrast, is being developed for hospitalized patients with moderate to severe COVID-19 who are at high risk of death. Our positive phase two clinical study in hospitalized COVID-19 patients in high-risk for acute respiratory distress syndrome showed that subisobulin treatment resulted in a 82% relative reduction in deaths compared to placebo. If our phase two clinical results were replicated to any significant degree in our global phase three clinical study, we believe subisobulin will fill a significant unmet medical need for hospitalized patients. We are conducting a phase three COVID-19 clinical study which is a double-blind, multi-center, multinational, randomized, two-to-one placebo-controlled study evaluating daily oral 9-milligram dose of sabizapulin for up to 21 days versus placebo in 300 hospitalized COVID-19 patients with high risk for acute respiratory distress syndrome. Primary emphasis endpoint will be the proportion of patients who die in our study up to day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in the ICU, WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. Studies being conducted in the U.S., Brazil, Argentina, Mexico, Colombia, and Bulgaria. In January of 2022, the FDA granted fast-track designation for the Phase III COVID-19 registration program. a distinction that underscores the urgent need for new novel and effective therapies to be used along with vaccinations to combat this COVID-19 pandemic. The company has sufficient clinical drug supply on hand to complete the phase three clinical study and to help fund the commercial drug to supply the needs of the US population, assuming confirmatory positive clinical results and FDA approval. We're seeking funding from BARDA and other agencies. The company anticipates having the results of the Phase 3 COVID-19 clinical trial in the first half of the calendar year 2022. As for our breast cancer drug portfolio, we have an expansive metastatic breast cancer program with two of our drug candidates, Inovasarm and Subizabule. Inovasarm is an oral selective androgen receptor targeting agonist, which has shown efficacy in Phase 2 clinical studies in a heavily pretreated hormone receptor-positive metastatic breast cancer patient population with an excellent safety profile without causing unwanted masculinizing adverse side effects. Novus arm represents the first and novel endocrine therapeutic approach to breast cancer in decades. Our second drug candidate, tabizabulin, is an oral cytoskeleton disruptor that targets unique binding sites and cross-links microtubules. a well-validated cancer target resulting in promising efficacy and a favorable safety profile without clinically relevant neurotoxicity, neutropenia, or alopecia. Furthermore, chronic oral daily administration is feasible. Our clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in hormone receptor-positive metastatic breast cancer. In the third-line treatment setting for hormone receptor-positive metastatic breast cancer, we have two clinical programs based on the patient's androgen receptor nucleotide staining or expression levels in their breast cancer tissue. For patients with greater than or equal to 40% androgen receptor expression, we are actively enrolling a global Phase III ART test registration clinical study to evaluate Inovasarm monotherapy for the third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. Inovasarm targets the angioreceptor, which has tumor suppressor activity in AR-positive, ER-positive, HER2-negative metastatic breast cancer without causing the unwanted masculinizing side effects. Inovasarm has extensive non-clinical and clinical experience, having been evaluated in 25 separate clinical studies in approximately 1,450 patients' dose, including three Phase II clinical studies in advanced breast cancer involving more than 250 patients. This means we have a very good understanding of the favorable safety profile of the NovoSARM. As for efficacy, there were two Phase II clinical studies conducted in women with AR-positive, ER-positive, or 2-negative metastatic breast cancer, where the NovoSARM demonstrated significant anti-tumor efficacy in the heavily pretreated cohorts that developed tumor progression after receiving estrogen blocking agents, chemotherapy, and or CDK4-6 inhibitors. And again, in this population, Inovasarm was well tolerated with a favorable safety profile. We are conducting a phase three multicenter international open-label randomized one-to-one ART test registration clinical trial to evaluate the efficacy and safety of Inovasarm monotherapy versus an active comparator of either Eximestane, plus or minus Everolimus, or a selective estrogen receptor modulator for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer in approximately 210 patients with greater than or equal to AR expression in their breast cancer tissue who have previously received a non-steroidal aromatase inhibitor for ovestrin and a CDK4-6 inhibitor. In January of 2022, FDA granted fast-track destination to our Phase III R test 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 where none exists or providing a therapy which may be potentially better than available therapy. Patients who are found to have less than 40% AR expression in their breast cancer tissue. We have a planned sister study, which is an open-label, multi-center, randomized, one-to-one phase 2B study, evaluating the efficacy and safety of sabizabule of 32 milligrams monotherapy versus the active comparative of either XMS-10 plus or minus epirolimus or CIRM for the treatment of ER-positive, ER-positive metastatic breast cancer in approximately 200 patients who have previously received a non-steroidal limitase inhibitor fulvestrin and a CDK4-6 inhibitor. For clarity, this means we have a sister study to randomize patients that did not qualify for the Phase III-R test study because their AR expression in the breast cancer tissue was too low. We received the safe-to-perceive letter from FDA, and this Phase II-B study is expected to commence in calendar Q1 2022. We're also moving a NovoSom therapy earlier in the treatment sequence into the second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancer by targeting patients with AR-positive breast cancer expression of greater than or equal to 40% in a Phase III Enabler II clinical study. The CDK4-6 inhibitor and an estrogen blocking agent combination has become the first-line therapy for patients with ER-positive HER2-negative advanced breast cancer. Unfortunately, almost all patients will develop drug resistance and will eventually develop breast cancer progression. Based on positive Phase II clinical data and the preclinical data supporting the use of adenocarcinoma in combination with a CDK4-6 inhibitor in patients who are CDK4-6 inhibitor and estrogen-blocking agent resistant, we plan to conduct a Phase III multi-sensor open-label randomized one-to-one active control registration clinical study named ENABLED-2. ENABLED-2 evaluates the efficacy and safety of the NovoSAR and abemacyclid combination therapy versus an alternative estrogen blocking agent in subjects with AR-positive, UR-positive, HER2 metastatic breast cancer who have failed first-line therapy with palpocyclid, which is a CDK4-6 inhibitor, plus an estrogen blocking agent, and who have greater than or equal to 40% AR expression in the breast cancer tissue. Plans are involved approximately 186 patients in this Phase III clinical study. We recently announced that we have entered into a clinical trial collaboration and supply agreement with Lilly for the Enabler II Phase III clinical study. In terms of the non-exclusive clinical trial collaboration and supply agreement, Vera is responsible for conducting the clinical trial, while Lilly will supply a memocyclic for the study. Vera maintains full exclusive global rights to Novozarm. We're looking forward to our collaboration with Lilly on the Enabler 2 Phase 3 clinical trial, which is expected to commence in calendar Q1 2022. We're partnering with Roche Ventana, a major global diagnostics company, to develop a companion diagnostic angioreceptor test. In the Phase 2 801 study, we determined that the presence and the amount of the angioreceptor expression in breast cancer tissue are important for the novus arms targeted anti-tumor activity. In fact, we identified that patients who have greater than or equal to 40% angio-receptor staining by immunohistochemistry, which is a measure of angio-receptor expression in the breast cancer tissue, are the patients that are most likely to have an anti-cancer response to a novus arm. Based on this observation, the FDA recommended that we develop a companion diagnostic test to determine the patient's AR expression status. Consequently, we have partnered with Roche-Ventana Diagnostics, world leader in oncology companion diagnostic tests. We're developing and have approved plans to commercialize the companion diagnostic antireceptor test. The companion diagnostic test is being developed in parallel with the phase three R-test clinical study. Although the study, although the company has been planning to commence a single arm subisobulin plus a novus arm combination the metastatic triple negative breast cancer patients in a phase two clinical study that was supposed to start early in this calendar year. We have now decided to focus our finite resources on more advanced pipeline opportunities and suspend work on this trial. Nevertheless, the company remains committed to advancing triple negative breast cancer study in the future. As you can see, we have developed an important and deep breast cancer program dedicated to developing novel we have late clinical stage studies addressing three separate indications. The first indication is evaluating sebizobulin, the third-line treatment of metastatic castration-resistant prostate cancer in the phase three veracity study. Several novel angio-receptor-targeted... ...lutamine and apalutamine. Unfortunately, most men with metastatic castration-resistant prostate cancer will develop tumor progression while receiving an antireceptor-targeted agent with 60% to 70% of patients progressing by 12 to 18 months and 30% to 40% of men having no benefit at all. New, effective, and well-tolerated treatment alternatives that do not target the antireceptor axis and that have an easy mode of administration are greatly needed. Invisibulin is a member of a novel class of drugs that disrupts the cytoskeletons by targeting unique binding sites on microtubules, which results in improved safety profile. Preclinical models, there was no evidence of significant liver toxicity, neurotoxicity, and neutropenia with subvisivulin treatment. This more tolerable safety profile has also been confirmed in a first-in-man phase 1b2 study in metastatic castration resistant prostate cancer patients. We will be presenting updated clinical data from the positive phase 1B2 study of subisipulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel angio-receptor targeting agent at the ASCO Janitor Urinary Cancer Symposium being held February 17th and 19th in San Francisco, California. He's conducting an open-label 2-to-1 multicenter phase 3 veracity clinical study evaluating sebizobulin 32 milligrams versus an alternative angioreceptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castrate-resistant prostate cancer who had tumor progression after previously receiving at least one angioreceptor-targeted agent. Primary endpoint is radiographic progression-free survival. Enrollment for the Phase III voracity clinical study is on track, and we expect to enroll approximately 245 patients from 45 clinical centers in the U.S. clinical study is evaluating VIR-100, a GnRH antagonist, a three-month depot formulation, in a phase two dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Androgen deprivation therapy remains the mainstay primary therapy for advanced prostate cancer, but current androgen deprivation therapy drug products have several important clinical shortfalls. LHRH agonists' initial administration leads to a testosterone surge that can last up to 21 days. Thermagon, a GnRH antagonist, is a large-volume subcontinuous injection formulation designed for only a single-month release. And Regagolex is an oral GnRH antagonist, but it has the potential for poor patient compliance. In contrast, Vero 100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercially available androgen deprivation therapy products. Vero 100 is a long-acting GnRH antagonist designed to be administered as a small volume subcutaneous three-month depot injection. Vero 100 drug product is expected to immediately suppress testosterone with no testosterone surge. And Vero 100 is a long-acting injected depot with insured patient compliance while on treatment. Furthermore, as a class, GnRH antagonists have been shown to have fewer cardiovascular adverse than LHRH agonists. We're conducting a Phase II dose-finding clinical study of Vero 100 angio-deprivation therapy in 35 men with hormone-sensitive advanced prostate cancer. Although this study is ongoing, preliminary clinical data are promising. Registration clinical study design has already been agreed upon with FDA. It will be a single-arm study which will enroll approximately 100 men. Maintenance of castrate blood concentrations of testosterone is the primary endpoint. After the Phase II dose-finding study is completed, we will initiate the Phase III clinical study, which is anticipated to begin in calendar second half of 2022. In our third late-stage clinical study, we plan to advance suclomiphene for the treatment of hot flashes caused by antigen deprivation therapy in a planned Phase IIb clinical study later in the calendar year of 2022. So in summary, We'll have three late-stage clinical studies for the management of advanced prostate cancer in calendar year 2022. Now, Vero has a commercial sexual health division called URADS, which includes two FDA-approved products, FC2 for the dual protection against 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 and highly convenient manner. Sales is not only to seek additional telemedicine and internet pharmacy service partners, but also to create our own has been shown to be more effective for the treatment of benign prosthetic hypoplasia than finasteride alone without causing impotence. and TADP was approved by FDA in December of 2021, and commercialization plans are now underway. The plan is to officially launch TADP next quarter. TADP is expected to be marketed and distributed also by our own direct-to-patient telemedicine and internet pharmacy services platform. We have also partnered with GoodRx, a US-based digital resource for healthcare, to reach their almost 20 million monthly visitors which include both consumer and healthcare providers, to build awareness, to send patients to our telemedicine platform, and to convert existing men on BPH treatments, those treatments that cause sexual side effects, to Intazbi. 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 US and ex-US. I will now turn the call over to Michelle Greco, the CFO and CAO to discuss the financial highlights. Michelle?