Veru Inc.

Good morning, ladies and gentlemen, and welcome to the VARU Incorporated Investor Conference Call. All participants will be in 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. And I'd like to turn the conference call over to Mr. Sam Fish, VARU Incorporated'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 portfolios. 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 developments that 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, Barueng's Chairman, CEO, and President. Good morning.

With me on this morning's call are Michelle Greco, the CFO and CAO, Dr. Gary Barnett, the Chief Scientific Officer, Michael Purvis, Executive Vice President, General Counsel in Corporate Strategy, and Tim Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Fiscal year 2021 was an exciting and very productive year for Beery. We have successfully transformed our company into a late-stage oncology biopharmaceutical company. we're developing novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer. One of our anti-cancer drugs, Avizabulin, has dual antiviral and anti-inflammatory effects and is also being developed for the potential treatment of hospitalized COVID-19 patients at high risk with acute respiratory distress syndrome, which remains a global dire unmet medical need. The company has a commercial sexual health division which includes a drug candidate in Tadfi, formerly referred to as Tadfin, a new treatment for benign prostatic hyperplasia, and a commercial product, the FC2 female condom, internal condom, and the FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. 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 the fourth fiscal quarter and record fiscal year 2021. As you are aware, we're still in the middle of the COVID-19 pandemic with no end in sight. Countries in Europe and other continents are now back in lockdown. Centers for Disease Control and Prevention have recently reported that the U.S. COVID-19 in the U.S., COVID-19 has killed 377,883 people in 2020 and 401,117 people in 2021. The year is not yet over. A new, potentially more troubling COVID-19 variant called Omicron has emerged in South Africa, and a case just has been confirmed in California. This new virus variant appears to have mutations that make it more contagious and may infect people that have been previously vaccinated, rendering the current choices of COVID-19 vaccines and antibody drugs less effective. The mechanism of drug action of subisobulin, is that it disrupts the microtubule intracellular transport of the coronavirus, a process that will still be required by new variants or strains of COVID-19, including Omicron, to cause infection. Well, there have been recent developments evaluating the Merck drug, and the Pfizer drug, Paxilobin, for the treatment of unhospitalized patients with mild to moderate COVID-19, who are at relatively low risk of dying. Subisobulin, in contrast, is being developed for hospitalized patients who are at high risk of death. In our positive phase two clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, subisobulin treatment resulted in an 82% relative reduction in deaths compared to placebo. In our phase two clinical studies, or results are replicated to any significant degree in our global Phase III clinical study, we believe subisobulin would fill in a significant unmet medical need for hospitalized patients. In May of 2021, we initiated the Phase III clinical study, which is a double-blind, multicenter, multinational, and randomized two-to-one placebo-controlled study evaluating daily oral doses of 9 mg subisobulin for up to 21 days versus placebo, standard of care, and 300 hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome. 200 subjects will be treated with subizobulin, and 100 subjects will receive placebo. The primary efficacy endpoint will be the proportion of patients who die on 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. The study is being conducted in the U.S., Brazil, Argentina, Mexico, Colombia, and Bulgaria. The company has sufficient clinical drug supply on hand to complete this Phase III clinical study. To help fund the commercial drug to supply the needs of the U.S. population, assuming confirmatory positive clinical results and FDA approval, we are seeking funding from BARDA and other agencies. The company anticipates having results for the Phase III clinical trial in the first half of calendar year 2022. As for our oncology drug portfolio, this was the year we initiated our expansive metastatic breast cancer program with two of our drug candidates, Inobusarm and Subizabulin. We are developing treatments against both hormone receptor-positive and triple negative metastatic breast cancers. Inobus arm is an oral selective androgen receptor targeted agonist, which has shown efficacy in phase two 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. Inobus arm represents the first new and novel endocrine therapeutic approach to breast cancer in decades. Our second drug candidate to bisabulin 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 of sibizabulin is feasible. Our clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in both hormone receptor positive and triple negative 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 nuclei 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 in a global phase three ART test registration clinical study to evaluate in Novosar monotherapy for the third-line treatment of androgen receptor positive, estrogen receptor positive, and human epidermal growth factor two negative metastatic breast cancer. Novus arm targets the antireceptor, which has a tumor suppressor activity in AR-positive, ER-positive, HER2-negative metastatic breast cancer without causing unwanted masculinizing side effects. Novus arm has extensive non-clinical and clinical experience, having been evaluated at 25 separate clinical studies in over 2,000 patients, 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 ER-positive HER2-negative metastatic breast cancer where NovoSARM demonstrated significant anti-tumor activity in heavily pre-treated cohorts that developed tumor progression after receiving estrogen-blocking agents, chemotherapy, and or a CDK4-6 inhibitor. And again, in this population, The NovoSARM was well-tolerated with a favorable safety profile. In October of this year, we initiated the Phase III Multisensor International Open Label Randomized One-to-One or Test Registration Clinical Trial to evaluate the efficacy and safety of the NovoSARM monotherapy versus an active comparative either Examestane plus or minus Eprolimus or CERN for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer in approximately 210 patients with greater than or equal to 40% AR expression in the breast cancer tissue after receiving a non-steroidal aromatase inhibitor, fulvestrin, and a CDK4-6 inhibitor. In patients with less than 40% AR expression, we have a planned phase 2B study to evaluate sebizobulin monotherapy for the third-line treatment of ER-positive or 2-negative metastatic breast cancer. The phase 2B clinical study will be an open-labeled multi-sensor, and randomized one-to-one study evaluating the efficacy and safety of sabizabulin 32 milligrams monotherapy versus active comparative either exomestane plus or minus everolimus or CIRM for the treatment of ER-positive HER2-negative metastatic breast cancer in approximately 200 patients with less than 40% AR expression in the breast cancer tissue after receiving a non-steroidal aromatase inhibitor, filvestrin, and a CDK4-6 inhibitor. We just received the safe-to-proceed letter from the FDA this month, and the Phase IIb study is expected to commence in calendar Q1 2022. We're also moving in over some earlier in the treatment sequence to the second-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer by targeting patients with AR breast cancer expression greater than or equal to 40% in the Phase III Enabler II clinical study. A CDK4-6 inhibitor and estrogen-blocking agent combination has become the first-line therapy for patients with ER-positive or 2-negative advanced breast cancer. Fortunately, almost all patients will develop drug resistance and eventually develop breast cancer progression. Based on the positive Phase II clinical data and the preclinical data supporting the use of a Novosarum 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 three multi-sensor, open-label, randomized one-to-one active control registration clinical study named ENABLER to evaluate the efficacy and safety of a Novocharm plus a Bemacycline combination therapy versus an alternative estrogen-blocking agent in subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer with failed first-line therapy with palbociclin, which is a CDK4-6 inhibitor, plus an estrogen-blocking agent, and have greater than or equal to 40% error expression in their breast cancer tissue. We plan to involve approximately 186 subjects in this Phase III clinical study, which is expected to commence in calendar Q1 2022. There will also be a scientific presentation on Inovus Arms' anti-tumor activity in estrogen-blocking agent and CDK4-6 inhibitor-resistant human metastatic breast cancer models, at the upcoming San Antonio Breast Cancer Symposium, which will be held December 7th through the 10th of 2021, to be presented by Dr. L. Jean Lim of the Garvan Institute of Medical Research and the Kinghorn Cancer Center at St. Vincent Hospital in Sydney, Australia. Although the presentation is under embargo, we cannot share the exciting scientific data until next week. What I can say is that these scientific results clearly demonstrate the anti-tumor synergy of the combination of anobisarm and a CDK4-6 inhibitor to treat patients who develop tumor progression after receiving an estrogen-blocking agent and a CDK4-6 inhibitor. Finally, for AR-positive metastatic triple-negative breast cancer patients, we will be conducting a Phase II single-arm study evaluating anobisarm plus sabizabulin combination therapy. As previously mentioned, sabizabulin is an oral first-in-class new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton. Overexpression of P-glycoprotein is a common mechanism that leads to taxane and other chemotherapy resistance in metastatic triple-negative breast cancer. And sabizabulin is not a substrate for P-glycoprotein. Sabizabulin significantly inhibited cancer proliferation, migration, metastasis, and invasion of triple-negative breast cancers that have become resistant to paclitaxel in preclinical models. Furthermore, In a phase two study conducted by Merck, 18 heavily pretreated women with AR-positive metastatic triple negative breast cancer treated by inovasarum plus pimerolizumab combination demonstrated promising evidence of efficacy, including a 25% clinical benefit rate, which is the complete response added to the partial response added to stable disease at 16 weeks, and objective tumor responses when they showed one complete response and one partial response. Thus, the combination of two oral agents, sabizabulin and Novosarm, may provide a new treatment option for women who have AR-positive metastatic triple negative breast cancer. We intend to commence a single-arm sabizabulin plus a Novosarm combination therapy phase two clinical study in approximately 111 women with AR-positive metastatic triple negative breast cancer who have tumor progression after receiving at least two systemic chemotherapies in calendar Q1 2022. We are partnering with Roche Ventana, a major global diagnostics company, to develop a companion diagnostic androgen receptor test. In the Phase II 801 study, we have determined that the presence and the amounts of the androgen receptor expression in breast cancer tissue were important for Novus arms targeted anti-tumor activity. In fact, We have identified that patients who have greater than or equal to 40% adrenoreceptor nucleotide staining by immunohistochemistry, which is a measure of AR expression in their breast cancer tissue, are the patients that are most likely to respond to InovaSARM. Based on this observation, the FDA has recommended that we develop a companion diagnostic test to determine the patient's AR expression status. Consequently, we are partnering with Roche Ventana Diagnostics a world-leading oncology companion diagnostic test, who will develop and, if approved, commercialize this companion diagnostic AR test. The companion diagnostic test will be developed in parallel with the Phase III AR test clinical study. Fiscal year 2022, we will have an expansive breast cancer program and plan to be conducting four late-stage clinical studies for the treatment of different large and important populations of significant unmet medical need in metastatic breast cancer. Also in fiscal year 2021, our prostate cancer program has made great progress. We have late clinical stage studies addressing three separate indications. Our first indication is evaluating subisobulin for the third-line treatment of metastatic prostate cancer in the Phase III veracity study. Over the past eight years, several novel androgen receptor targeting agents have been approved for castration-resistant prostate cancer, including abiraterone, enzalutamide, and apalutamide. Unfortunately, most men with metastatic castration-resistant prostate cancer will develop tumor progression while receiving an angio-receptor-targeted agent, 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 angio-receptor axis and have an easy mode of administration are greatly needed. Visibulin is a member of a novel class of truss that disrupts the cytoskeleton by targeting unique binding sites of microtubules, which results in an improved safety profile. In preclinical models, there was no evidence of significant liver toxicity, neurotoxicity, and neutropenia with visibulin treatment. This more tolerable safety profile was also confirmed in the first in-man phase 1b2 study and prostate cancer patients. At a recent presentation by the European Society for Medical Oncology Congress that was held September 16th to 21st, 2021, we provided an update analysis of the 80 patients enrolled in both the Phase 1B and Phase 2 portions of the study. These subjects were heavily pretreated and had tumor progression while receiving at least one novel endoreceptor-targeted agent. In fact, Approximately 40% of the subjects had tumor progression after receiving at least two androgen receptor-targeted agents. In regard to safety, there were 54 men treated at the recommended Phase II dose of subvisibulin 63 milligrams oral daily dosing in the Phase Ib2 combined study. Subvisibulin was well-tolerated with no clinically relevant neutropenia neurotoxicity, and the most common adverse events were gastrointestinal-related, including diarrhea, nausea, and fatigue, which were predominantly low-grade 1 and 2. As for efficacy, in combining patients from both the Phase 1B and 2 studies who received 63 milligrams of subizobulin daily and had measurable metastatic disease at baseline based on the prostate cancer work in Group 3 criteria, the median radiographic progression-free survival is estimated to be 7.4 months with a range of 3.2 to 35-plus months as there are still five patients on the study, which two have been on subizobulin without tumor progression for almost three years. In the phase 1b2 study population with measurable disease at baseline per resist 1.1, the overall response rate was 21%. Based on this phase 1b2 study, subizobulin demonstrated a safety profile similar to what has been reported in the literature, but in novel angio-receptor targeted agents, and has promising evidence of efficacy similar to or better than IV chemotherapy. Thus, these updated findings from our Phase 1B2 clinical study of subisobulin continue to support the potential role of subisobulin filling a growing significant unmet medical need. In June, the company initiated an open-label randomized two-to-one multi-center Phase 3 veracity clinical study evaluating sabizabulin versus an alternative androgen receptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer who have had tumor progression after receiving at least one androgen receptor-targeted agent. The primary endpoint is radiographic regression-free survival. Enrollment for the Phase III veracity clinical study is on track. We expect to enroll approximately 245 patients from 45 clinical centers in the U.S. Our second clinical study is evaluating Vero 100, a GnRH antagonist three-month depo 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. Lupron, Elgar, and Zolidex are LHRH agonists whose initial administration leads to a testosterone surge that lasts up to 21 days. Firmagon, a GnRH antagonist, is a large volume subcutaneous injection formulation designed for only a single month release. Relagolix is an oral GnRH antagonist and has the potential for patient compliance concerns. In contrast, Vero 100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercial 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 products are expected to immediately suppress testosterone with no testosterone surge. Vero 100 as a long-acting injected depot would ensure patient compliance while on treatment. Furthermore, as a class, GnRH antagonists have been shown to have fewer cardiovascular adverse events than an LHRH agonist. In June, the company initiated the Phase II dose-finding clinical study of 0100 antidepressant therapy in 35 men with hormone-sensitive advanced prostate cancer. Although the study is ongoing, the preliminary clinical data are promising and support the expected target product profile. The Phase III 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. After the Phase II dose-finding study is completed, we will initiate the Phase III clinical study, which is anticipated to begin in calendar first half of 2022. In our third late-stage clinical study, we are advancing Zuclomiphene for the treatment of hot flashes caused by androgen deprivation therapy. Upon further evaluation of the clinical data from our positive Phase II Zuclomiphene clinical study, we decided that because of Zuclomiphene's excellent safety profile, that we should optimize the efficacy of Zuclomiphene to treat hot flashes by further increasing the dose in a planned Phase IIb clinical study. In summary, we will have three late-stage clinical studies for the management of metastatic prostate cancer in fiscal year 2022. The Bureau has a base commercial sexual health division, which includes a commercial product, the FC2, an FDA-approved product for the dual protection against unplanned pregnancy and transmission of sexually transmitted infections, and the drug candidate, Intafi, which is Tadalfil 5mg and Finasteride 5mg Capsule, a new treatment for benign prosthetic hyperplasia with an FDA-produced date this month. We have built the infrastructure to allow for broad access to FC2 across the United States. 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 FC2 product to patients in a cost-effective and highly convenient manner. Although Ms. Greco will provide the full financial results in Bureau's commercial segment, which is FC2 and drug commercialization costs, I'm happy to report that we've achieved another record fiscal year. In fact, our revenue increased 44% to $61.3 million, which significantly exceeded the revenue of $42.6 million we had in fiscal year 2020. Our strategy is to continue to drive robust FC2 sales, not only to seek additional telemedicine and pharmacy services partners, but also to create our own dedicated direct-to-patient telemedicine and pharmacy services platform, both to brand our company and to further sales growth. We plan to also brand our new name, UREV, for our women's health business. We also have developed a tap fee in novel treatment for benign prostatic hyperplasia, The co-administration of sedalafil and finasteride have been shown to be more effective with treatment of benign prosthetic hyperplasia than finasteride alone without causing sexual adverse side effects. The PDUFA date is in December of 2021. If approved, Entapathy is expected to be marketed and distributed by our own direct-to-patient telemedicine and telepharmacy platform. We have also 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, and offers a unique cash prize to ensure that our treatment is more affordable and accessible. We plan to augment our marketing and sales efforts by seeking partners in the U.S. and ex-U.S. We expect to begin commercialization, if approved, in early calendar year 2022. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?