Good morning, ladies and gentlemen, and welcome to Veru 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. I'd now like to turn the conference call over to Mr. Sam Fisch, 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 of 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 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 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 Michele Greco, the CFO and CAO, Dr. Gary Barnett, the Chief Scientific Officer, Michael Purvis, Executive Vice President, General Counsel, and Corporate Strategy, and Sam Fisch, 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 Veru. We have successfully transformed our company into a late stage oncology biopharmaceutical company. We are developing novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer. One of our anticancer drugs, sabizabulin, has dual antiviral and anti-inflammatory effects and 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, which includes a drug candidate ENTADFI, 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 multibillion-dollar premium market opportunities. This morning, we will discuss Veru'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. The Centers for Disease Control and Prevention have recently reported that 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 from 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 sabizabulin 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. While there have been recent developments evaluating the Merck drug, molnupiravir, and the Pfizer drug, Paxlovid, for the treatment of unhospitalized patients with mild to moderate COVID-19 who are at relatively low risk of dying. Sabizabulin, in contrast, is being developed for hospitalized patients who are at high risk of death. In our positive phase II clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, sabizabulin treatment resulted in an 82% relative reduction in deaths compared to placebo. If our phase II clinical studies' results are replicated to any significant degree in our global phase III clinical study, we believe sabizabulin would fill a significant unmet medical need for hospitalized patients. In May 2021, we initiated the phase III clinical study, which is a double-blind, multicenter, multinational, and randomized 2-to-1 placebo-controlled study evaluating daily oral doses of 9 mg sabizabulin for up to 21 days versus placebo standard of care in 300 hospitalized COVID-19 patients who had high risk for acute respiratory distress syndrome. 200 subjects will be treated with sabizabulin, 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 of the phase III clinical trial in the first half of calendar year 2022. As for our oncology drug portfolio, this was a year we initiated our expansive metastatic breast cancer program with two of our drug candidates, enobosarm and sabizabulin. We are developing treatments against both hormone receptor-positive and triple-negative metastatic breast cancers. Enobosarm is an oral selective androgen receptor-targeted agonist, which has shown efficacy in phase II 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. Enobosarm represents the first new and novel endocrine therapeutic approach to breast cancer in decades. Our second drug candidate, sabizabulin, is an oral cytoskeleton disruptor that targets unique binding sites in cross-linked 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 sabizabulin 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 nuclear 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 ARTEST registration clinical study to evaluate enobosarm monotherapy for the third-line treatment of androgen receptor-positive, estrogen receptor-positive, and human epidermal growth factor two-negative metastatic breast cancer. Enobosarm targets the androgen receptor, which has a tumor suppressor activity in AR-positive, ER-positive, HER2-negative metastatic breast cancer without causing unwanted masculinizing side effects. Enobosarm has extensive non-clinical and clinical experience, having been evaluated in 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 with enobosarm. As for efficacy, there were two phase II clinical studies conducted in women with AR-positive, ER-positive, HER2-negative metastatic breast cancer, where enobosarm demonstrated significant antitumor activity in heavily pretreated cohorts that developed tumor progression after receiving estrogen-blocking agents, chemotherapy, and/or CDK4/6 inhibitor. Again, in this population, enobosarm was well-tolerated with a favorable safety profile. In October of this year, we initiated the phase III multicenter international open-label randomized 1:1 ARTEST registration clinical trial to evaluate the efficacy and safety of enobosarm monotherapy versus an active comparator, either exemestane plus or minus everolimus or a SERM, for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer in approximately 210 patients with ≥40% AR expression in their breast cancer tissue after receiving a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. In patients with <40% AR expression, we have a planned phase II-B study to evaluate sabizabulin monotherapy for the third-line treatment of ER-positive, HER2-negative metastatic breast cancer. The phase II-B clinical study will be an open-label, multicenter, and randomized 1:1 study evaluating the efficacy and safety of sabizabulin 32 mg monotherapy versus active comparator, either exemestane plus or minus everolimus or a SERM, for the treatment of ER-positive, HER2-negative metastatic breast cancer in approximately 200 patients with less than 40% AR expression in their breast cancer tissue after receiving a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor. We just received the Safe to Proceed letter from the FDA this month, and the phase II-B study is expected to commence in calendar Q1 2022. We're also moving enobosarm 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 ENABLAR-2 clinical study. The CDK4/6 inhibitor and 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 eventually develop breast cancer progression. Based on the positive phase II clinical data and the preclinical data supporting the use of enobosarm 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-center open-label randomized one-to-one active control registration clinical study named ENABLAR to evaluate the efficacy and safety of enobosarm plus abemaciclib 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 palbociclib, which is a CDK4/6 inhibitor, plus an estrogen blocking agent and have greater than or equal to 40% AR 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 enobosarm's 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 10th, 2021, to be presented by Dr. Elgene Lim of the Garvan Institute of Medical Research and the Kinghorn Cancer Centre at St Vincent's Hospital in Sydney, Australia. Although the presentation is under embargo, and 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 enobosarm 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 enobosarm 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-glyco protein is a common mechanism that leads to taxane and other chemotherapy resistance in metastatic triple- negative breast cancer. As sabizabulin is not a substrate for P-glycoo protein, 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 II study conducted by Merck, 18 heavily pretreated women with AR-positive metastatic triple-negative breast cancer treated by enobosarm plus pembrolizumab 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 enobosarm, may provide a new treatment option for women who have AR-positive metastatic triple-negative breast cancer. We intend to commence a single-arm abemaciclib plus enobosarm combination therapy phase II 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 calendar Q1 2022. We are partnered with Roche Ventana, a major global diagnostics company, to develop a companion diagnostic androgen receptor test. In the phase II 81 study, we have determined that the presence and the amounts of the androgen receptor expression in breast cancer tissue were important for enobosarm's targeted anti-tumor activity. In fact, we have identified that patients who have greater than or equal to 40% androgen receptor nuclear 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 enobosarm. Based on this observation, the FDA has re-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 leader in oncology companion diagnostic tests, 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 ARTEST 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 sabizabulin for the third0 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 androgen receptor-targeted agent. 60%-70% of patients progressing by 12-18 months and 30%-40% of men having no benefit at all. New, effective and well-tolerated treatment alternatives that do not target the androgen receptor axis and have an easy mode of administration are greatly needed. Sabizabulin is a member of a novel class of drugs 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 sabizabulin treatment. This more tolerable safety profile was also confirmed in the first-in-man phase I-B/II study in prostate cancer patients. At a recent presentation by the European Society of Medical Oncology congress that was held September 16 to 21, 2021, we provided an updated analysis of the 80 patients enrolled in both the phase I-B and phase II portions of the study. These subjects were heavily pretreated and had tumor progression while receiving at least one novel androgen receptor 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 sabizabulin 63 mg oral daily dosing in the phase I-B/II combined study. Sabizabulin 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 I-B and II studies who received 63 mg of sabizabulin daily and had measurable metastatic disease at baseline based on the Prostate Cancer Working Group 3 criteria, the median radiographic progression-free survival is estimated to be 7.4 months with a range of 3.2-35+ months as there are still five patients on the study, which two have been on sabizabulin without tumor progression for almost three years. In the phase I-B/II study population with measurable disease at baseline per RECIST 1.1, the overall response rate was 21%. Based on this phase I-B/II study, sabizabulin demonstrated a safety profile similar to what has been reported in the literature for the novel androgen receptor targeted agent and has promising evidence of efficacy similar to or better than IV chemotherapy. These updated findings from our phase I-B/II clinical study of sabizabulin continue to support the potential role of sabizabulin filling a growing significant unmet medical need. In June, the company initiated an open-label randomized 2-to-1 multicenter phase III 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've had tumor progression after 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 from 45 clinical centers in the U.S. Our second clinical study is evaluating VERU-100, a GnRH antagonist three-month depot formulation in a phase II 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, Eligard, Zoladex, or 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. Relugolix is an oral GnRH antagonist and has the potential for patient compliance concerns. In contrast, VERU-100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercial androgen deprivation therapy products. VERU-100 is a long-acting GnRH antagonist designed to be administered as a small volume subcutaneous three-month depot injection. VERU-100 drug product is expected to immediately suppress testosterone with no testosterone surge. VERU-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 VERU-100 androgen deprivation 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 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 first half 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 II-B clinical study. In summary, we will have three late stage clinical studies for the management of metastatic prostate cancer in fiscal year 2022. Veru 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, ENTADFI, which is tadalafil 5 mg and finasteride 5 mg capsule, a new treatment for benign prostatic hyperplasia with a FDA PDUFA 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 Veru'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 pharmacy services platform, both to brand our company and to further sales and to further sales growth. We plan to also brand it our new name, Urev, for our women's health business. We also have developed ENTADFI, a novel treatment for benign prostatic hyperplasia. The co-administration of tadalafil and finasteride have been shown to be more effective for the treatment of benign prostatic hyperplasia than finasteride alone without causing sexual adverse side effects. The PDUFA date is in December 2021. If approved, ENTADFI 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 include both consumers and healthcare providers, and offers a unique cash price to ensure that our treatment is more affordable and accessible. We plan to augment our marketing and sales effort 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 Michele Greco, CFO, CAO, to discuss the financial highlights. Michele? Thank you, Dr. Steiner. As Dr. Steiner indicated, we had another great year. Last December, the company sold PREBOOST for $20 million, resulting in a gain on sale of $18.4 million. In February, the company completed an equity raise, which resulted in $108 million in net proceeds after deducting underwriting commissions and costs. For the fiscal year, the company achieved record- level net revenues of $61.3 million and record- level gross profits of $47.9 million. Let's start with highlights of our fourth quarter results for fiscal year 2021. Overall net revenues were up 33% to $15.6 million from $11.7 million in the prior year fourth quarter due to the growth in our U.S. FC2 prescription business. The company reported significant FC2 sales growth in its prescription business with net revenues up 55% to $13.6 million from $8.7 million in the prior year fourth quarter. Gross profit was $12.3 million for 79% of net revenues, compared to $9.6 million or 81% of net revenues in the prior year fourth quarter. The increase in gross profit is driven primarily by increased sales in our U.S. FC2 prescription business. Operating expenses for the quarter increased by $7.4 million to $14.2 million compared to the prior year fourth quarter of $6.7 million. Research and development costs were $8.3 million compared to $3.3 million in the prior year quarter due to the commencement of several new phases in our clinical trials. During the fourth quarter of fiscal 2020, we recorded a non-cash impairment charge of $14.1 million related to in-process research and development associated with the acquisition of Aspen Park Pharmaceuticals in fiscal 2017. Operating loss for the quarter was $1.9 million compared to the prior period of $11.3 million, which included the non-cash impairment charge of $14.1 million. Non-operating expenses were $2.8 million compared to $1.7 million in the prior year fourth quarter, and primarily consisted of interest expense and a change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax benefit of $356,000 compared to a tax benefit of $1.1 million in the prior year fourth quarter. The effective tax rate for this quarter is 7.7% and 8.6% for the prior year quarter due to recording a valuation allowance against the net operating loss generated for the quarter in the U.S., which is most of the pre-tax loss for the period. The bottom line results for the fourth quarter fiscal 2021 was a net loss of $4.3 million, or $0.05 per diluted common share, compared to a net loss of $11.8 million or $0.17 per diluted common share in the prior year fourth quarter. Now turning to the results for the fiscal year ended September 30th, 2021. Total net revenues for fiscal year 2021 were up 44% to a record high of $61.3 million from $42.6 million in the prior year. The company reported growth in FC2 sales in the U.S. prescription business and in the global public sector business. Net revenues from the U.S. prescription business was up 71% to $46.5 million from $27.1 million in the prior year. Net revenues for the global public health sector business was $13.9 million for the fiscal year. Overall, gross profit was $47.9 million for 78% of net revenues, compared to $30.8 million or 72% net revenues in the prior year. The increase in gross profit and gross margin is due primarily to the increase in the U.S. prescription business. Operating expenses increased to $53.3 million compared to the prior year of $31.4 million. The increase is primarily driven by research and development costs, which increased to $32.7 million from $16.9 million in the prior year, and increases in the cost of personnel insurance and commercialization. During the prior year, the company received a forgivable loan of approximately $540,000 under the Paycheck Protection Program of the CARES Act. The forgivable loan was treated like a government grant and recognized there was a reduction in operating expenses. During the first quarter of fiscal 2021, we sold PREBOOST, resulting in a pre-tax gain of $18.4 million. During the fourth quarter in the prior year, there was a non-cash impairment charge of $14.1 million. Operating income for the year was $13 million, which includes the $18.4 million related to the gain on sale of PREBOOST, compared to an operating loss of $14.7 million in the prior year, which includes the non-cash impairment charge of $14.1 million. Non-operating expenses were $8.7 million compared to $5.3 million in the prior year, which primarily consisted of interest expense and change in the fair value of the derivative liabilities related to synthetic royalty financing. For the year, we recorded a tax benefit of $3.1 million compared to $1.1 million in the prior year. The tax benefit primarily relates to an increase in U.K. tax rates from 19% to 25%, which will be effective in fiscal 2023. This change in tax rates increased the value that we expect to derive from our net operating losses in the U.K. The company has net operating loss carryforwards for U.S. federal tax purposes of $39.1 million, with $30.5 million expiring in years through 2040 and $8.6 million, which can be carried forward indefinitely. Our U.K. subsidiary has net operating loss carryforwards of $63.5 million, which do not expire. The bottom line results for fiscal year 2021 was net income of $7.4 million or $0.09 per diluted common share, compared to a net loss of $19 million for $0.28 per diluted common share in the prior year. Now turning to the balance sheet. As of September 30, 2021, our cash balance was $122.4 million, and our accounts receivable balance was $8.8 million. Our net working capital was $136 million on September 30th, 2021, compared to $12.3 million on September 30th, 2020. Due to the sale of PREBOOST in December 2020, we added $15 million in cash and $5 million in notes receivable, $2.5 million, which will be collected this month, and the remaining $2.5 million, which will be collected over the next six months. In February, we completed an underwritten public offering that resulted in net proceeds of $108 million. During the fiscal year ended September 30th, 2021, we used cash of $15.6 million for operating activities. Overall, we're delighted to see the continued increases in sales in the FC2 business. This revenue source, together with our strong balance sheet, continues to be the source of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium oncology biopharmaceutical company seeking large market opportunities in breast and prostate cancers, as well as being opportunistic by joining the global efforts to find effective treatments for COVID-19. Now, I'd like to turn the call back to Dr. Steiner. Thank you, Michele. We've enjoyed a record year, which has allowed us to significantly advance our clinical oncology programs. In fact, we are now entering our fifth year of growth in our FC2 U.S. prescription business. We had a record year of $61.3 million in revenue. We plan to commercially launch TADFIN if approved via telemedicine portal and potential licensing deals, which will provide even more revenue, adding to the already growing revenues from FC2. We expect another record year in fiscal year 2022. With resources in place, we will continue to advance our expansive late clinical stage breast cancer and prostate cancer programs, as well as phase III COVID-19 clinical study that's expected to have results in the first half of 2022. We anticipate a steady flow of important positive news for Veru over the next few months to one year. In summary, we have evolved into an oncology biopharmaceutical company solidly dedicated to developing treatments for breast cancer and prostate cancer. Our strategy to advance the clinical development of our drug candidates by investing revenues generated by our sexual health division is working. As a standalone business, our women's health business, Urev, is valuable, profitable and growing, which provides optionality to Veru shareholders. I am proud of the hardworking, dedicated, and talented team we have assembled to execute our clinical and commercial strategy. We are committed to driving shareholder value by developing commercial novel medicines, addressing significant unmet medical needs for the management of breast cancer, prostate cancer, and being opportunistic by developing sabizabulin for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome and death. With that, I'll now open the call to questions. Operator? Thank you. Ladies and gentlemen, at this time, we will begin the question- and- answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star then one to rejoin the question queue. Our first question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead. Hi. Thanks for taking my questions, and congratulations on all the progress. The two questions from me, maybe just on sabizabulin and COVID. Can you remind me what the control arm is able to be dosed with? Along those lines, how active are you in dialogue with the respective agencies on those endpoints just as sort of COVID treatments evolve? I guess my second question I'll just ask up front on sabizabulin again in the third-line monotherapy and breast. You noted you received a safe-to-proceed letter from the FDA. Can you just let us know, are there any other hurdles you have to overcome between now and starting the phase II-B? Is it now just are you just really setting up the study and getting it running in the first quarter of next year? Thank you. First of all, Brandon, thank you for being on the call. I'm gonna answer your second question first. That's an easy one. Safe to proceed letter is, you know, typically what you do technically after you file. Now, this had to be filed as a separate IND because it's a different drug. With that said, safe to proceed letter is the official green light from the FDA to move forward. There are no other hurdles. All we're doing now is we've got everybody engaged. We have a CRO ready to go. Just to pause for a moment, let me tell you why this is unique and maybe didn't come across in the call. What we're doing is we're actually asking, if you look at the populations of the patients in the greater than 40 and less than 40, it's the same population of patients. These are patients that have received at least two estrogen- blocking agents and the CDK4/6 inhibitors. They're all third line. When they come into the study, then the companion diagnostic, or in this case it'll be, you know, the CLIA test, look for their AR status. If their AR status is greater than 40, greater than or equal to 40, then they go on to the ARTEST study. If it's less than 40, then they go to the phase II- B study. In some ways, they're sister companion studies. We're being incredibly efficient with money because that same patient, instead of being told you can't be in the study, and you chalk that up as a screen failure, whatever you call that, now we have an opportunity to capture that patient in one or the other study. It really is a very efficient way to fill that study. I maybe that didn't come across as loudly as I'd like it to. With that said, there are no hurdles. In fact, we're starting to collect patients for recruitment because the ARTEST study is up and running, and we do have patients that are less than 40, so it'll be pretty efficient. Our thinking was that since we know less than 40s are not gonna respond the way the greater than 40s do, let's take advantage of another one of our assets. As it relates to the second question, I'll frame the question. We're very fortunate to have here Dr. Gary Barnett will answer the question. That was basically for the COVID-19 study, looking at the control arm, just to remind you again what that control arm was in the phase II-B, and then what the control arm is in the phase III. The other part of your question was, you know, dialogue with the FDA in relation to that endpoint and how comfortable they are with that endpoint. Gary? Yeah. In the phase II study and in the phase III study, we do allow standard of care. These are both blind. The phase II is a blinded study. This is a blinded study. We ethically need to allow them to have standard of care, things like dexamethasone, remdesivir, the other products that have been approved by the FDA through the EUA process. Then on top of that, we have a blinded either the patient is randomized to sabizabulin or to placebo. That's how the studies work. The phase III study is identical in that way to the phase II where we showed the benefit. As far as the endpoint, the FDA's, you know, obviously, mortality or death is the gold standard endpoint for just about every clinical trial you have or you could have. Now, we don't use it much because most of the time we're trying to do something else. The FDA is very comfortable with death as the primary endpoint. Based on the phase II data we have and the data we're seeing in the literature, we feel very comfortable that that's where we should be. I think the other statement I will make is that, you know, it's been very. The reason I brought it up, the Merck and the Pfizer drugs are not for hospitalized patients. In fact, the Merck drug failed in hospitalized patients. They're in pre-hospitalized patients, and this patient group will have a much, much lower overall death rate. In the hospitalized patients, one of the concerns we had running this study was that perhaps with this, quote, "standard of care," dexamethasone, remdesivir with, you know, and drug antibody cocktails and that kind of stuff, that the death rate would be at a point that it's, you know, much lower, that we would need a huge study. That's not the case. What we're learning is that patients are coming in WHO 5s and 6s, and quite frankly, 4s. You know, the death rate is the same, if not higher, than what we saw in phase II. We can say that in aggregate. We're feeling pretty good that there is a big difference between going after patients in a pre-hospitalization standpoint versus a hospitalized standpoint, 'cause the hospitalized patients are definitely sicker. That's why we think we have a position with our drug that at this point now, there really been no effective drugs, oral drugs that have been approved in this space or any coming up, you know, coming anytime soon. We really own this space, and that's why we gotta push it pretty hard. Okay. Next question. Next question's from Leland Gershell from Oppenheimer. Please go ahead. Good morning, Mitch. Thank you for taking my question. Just actually one question, it's on sabizabulin. It's kind of a mechanistic one. You know, there's another compound being developed elsewhere, plinabulin, which also, you know, binds proximate to the colchicine binding site on tubulin. In addition to that, it's been recently published that that compound may play an immuno-oncologic role, as it releases an immune defense protein, GEF-H1. I'm just wondering if on work you've done with sabizabulin, if you've seen other elements of activity that may be along those lines, you know, in addition to the known activity with the disruption of microtubules. Thank you. Thank you. Yeah, from a mechanistic standpoint, let me just pause for a moment and tell you what I think is happening with plinabulin. First of all, from a mechanistic standpoint, plinabulin started out as a colchicine binding site compound on the beta subunit of the tubulin. What I don't know, quite frankly, is what does it do on the alpha subunits of tubulin? The alpha subunit, the binding site on the alpha tubulin subunit, I don't know, okay? With our compound, what makes it different, and that's why I keep saying we're a novel class, is that it looks like I have not seen another compound that has hydrogen bonding on the beta subunit and the hydrogen bonding on the alpha subunit of tubulin. That's why we're saying it's cross-linking, because those bonds are so strong that it's actually cross-linking and causing the microtubules not only to not be able to polymerize, but also they cause them to depolymerize. It's a little different. Now, with that said, and we think this is the reason for the safety, we do think there's some overlap. Plinabulin clinically shows a reduction in neutropenia. End of story. They had a very successful phase III that showed a reduction in neutropenia. As you know, when you go after side effects of chemotherapy, the agency usually requires two clinical studies. Even though plinabulin shows great success and proof of concept in a phase III setting that it can reduce the neutropenia induced by chemotherapy, the agency asked them for a second one. It's not shocking from my point of view. You know, and I don't know, I have not read the regulatory documents or anything like that, but from the outside looking in, you know, they usually want two. Like, for example, our hot flash product, you know, even though we're treating cancer patients, the FDA has made it very clear they'd like two pivotal studies. It could be a phase II-B and a phase III, but they want two studies where they can move forward with treating the side effects of a cancer drug. In this case, treating the side effects of androgen deprivation therapy-induced hot flashes. It's the same thing here. It's chemotherapy-induced neutropenia. It's similar. As it relates to other things, I will tell you that, you know, sabizabulin's already shown us that it can have activity in as an antiviral and an anti-inflammatory, and that's why we're using it in COVID-19. We've actually, you know, presented, you know, put out in the press release the anti-inflammatory activity across multiple cytokine proteins that are downregulated or inhibited by sabizabulin. It's not surprising to me that sabizabulin may have immunomodulating activities, but we have not tested specifically the immunomodulating activities that plinabulin has. So I can't tell you whether they're similar in that regard, but I would not be surprised. So the net-net of it is we're different, but there's some overlap. What we can say about sabizabulin, all that preclinical stuff where we showed, you know, neutropenia, neurotoxicity in the preclinical models didn't appear to be important, or did not appear to happen with the compound played out in the clinical model. We're feeling pretty good going forward in breast cancer that we should be able to still see the favorable side effect profile with sabizabulin. Thank you. Thank you. Next question, please. Next question's from Yi Chen from H.C. Wainwright. Please go ahead. Thank you for taking my questions. Just to clarify, the companion diagnostic AR test being developed is the test you use in the ARTEST study to measure the AR expression. Is that correct? Are there any other currently available tests to measure AR expression level? Let me answer that question. The question is basically, are we using companion diagnostic tests being developed with Roche Ventana currently to measure androgen receptor expression in the patients entering the ARTEST study? That's question one. The answer is no, we're not. We're using an AR CLIA test. What we plan to do during the ARTEST phase III is to begin to bridge into the commercial test that's being developed by Roche Ventana. This is not unusual. This is done often. We're using an AR CLIA test versus a CLIA test. A CLIA test means it's a laboratory-developed test. It's done with all the controls and everything. It's done with the same antibody. It's done the same way, but it's not designated commercial test and not designated as an FDA-approved test. We're doing that and bridge into the ARTEST study. We have plenty of samples between the ARTEST study and the other three studies that are being done in the ENABLAR study. It's a phase III and the phase II-B less than 40s. We have plenty of samples. We feel very, very comfortable that Ventana Roche, who's an expert in developing the diagnostic tests. We're not, so that's why we're having the global diagnostic company do it for us. We'll focus on drug development. The short answer of the long answer is that yes and no. What's gonna happen towards the tail of the study is probably by the time we're in the middle of it all, that we would've switched over to the companion diagnostic, and we'll have plenty of information. As a result here, the concept would be that the AR test would be ready to be submitted to the FDA at the same time we file the clinical data for the ARTEST study. Interestingly, the same commercial companion diagnostic test can also be used and not have to be revalidated in other patient populations and be used in the combination studies that we're doing. Really, this opens up the companion diagnostics are being used across all of the AR studies. You know, an interesting fact is, you know, Ventana Roche at this point, I think is doing about 85% of the initial testing that's done in breast cancer in a woman to molecularly characterize their tissue, the breast cancer. In other words, do they have ER positive? Are they PR positive, progesterone receptor, HER2 negative? That panel's actually done by Roche. If Roche can come in and we were able to, and this is me dreaming for a moment, we can be in a situation where every woman will know their AR status from the very beginning. That would, and then hopefully be a footnote of some sort that, you know, opens up the possibility that enobosarm could be available in the future. This could be very, very interesting from a marketing commercialization standpoint. Now with that said, you know, ER, you know, ER is done by immunohistochemistry as well, estrogen receptor. That was grandfathered in. The FDA doesn't have a companion diagnostic for ER. However, HER2 negative, I mean, excuse me, HER2, whether it's negative or positive, is, it does have a companion diagnostic. It had to be approved. The FDA, when they saw what the results that we presented to them for the androgen receptor, they made very clear that, you know, although many laboratories across the world are doing androgen receptor immunohistochemistry in a standard fashion, that they require because it's so important to treat the right women to get the best effect by, if by going after greater than or equal to 40%. The flip side is true, too, and that is that if we're not seeing the same kind of activity in the less than 40s, they shouldn't be subjected to a drug that is not gonna provide them benefit. The FDA took the position that, because this is critical, that it should be a companion diagnostic. When we now fast-forward into now we have an approved product in Ventana, hopefully then in that situation, the companion diagnostic will be available. AR testing will be done in other laboratories, but the one that would be approved will be the combination of Ventana and the companion diagnostic. Got it. Based on current enrollment status, when do you expect the ARTEST study and the VERACITY study to complete enrollment? Gary? Yeah. I, you know, obviously we're on track on both of them, and we expect toward the end of 2022 into 2023. That's our targets. We're targeting data readout. Again, this is, you know, we're not trying to guide or anything, but we certainly targeting data readout in sort of mid-2023, and quite frankly, for both studies. Yeah. They're really close. Got it. Thank you. Thank you. Next question, please. Our next question comes from Chris Howerton from Jefferies. Please go ahead. Hey, great. Thanks so much for taking the questions. Mitch, I may have missed it, but I just was wondering if there was any updated strategy for the FC2 business. I know there was some thoughts of divestiture, but obviously it's been doing pretty well. That would be one question. The follow-up to that would be, could you provide some guidance or some thinking, with respect to that business for, next fiscal year, please? Thank you. I'll answer the second. Well, let me answer the first question. The, you know, as we mentioned, and publicly put out that we were exploring strategic options for the FC2 business. Strategic options doesn't always mean that you just go off and sell it off. It means, you know, what's the best way to maximize shareholder value. As I also said many times is that we're not in a rush. We're making lots of money off the product, and it's paying for our development. It's not like we have to get rid of it. If anything, I love the damn business, but it's, you know, it's, we're just trying to figure out how we can get, instead of a 1 + 1 = 0.5, how do we get a 1 + 1 = 10? You know, we've got a very different shareholder base looking at the base business. We have a different shareholder base and their expectations for the pharmaceutical business. But with that said, what's important to us is we're running a business. What we're doing is we're continuing to understand the options that we have for the FC2 business. We're treating the business as if we're never gonna get rid of it, so that we make sure we make the right decisions to continue to grow the revenue. At the same time, we're being very opportunistic in understanding what is the best next step for the asset. Stay tuned. As it relates to revenue, as I mentioned in our call, you know, we have put additional, again, along those lines in treating it like our own baby, we have put in some additional ways to continue to grow the business. I mean, we're in our fifth year of growth now. In this past year, we did a 44% revenue growth. It just keeps happening. For some reason, when you start looking at other women's health companies, and we all know many of them that you guys have been following, we kind of blow them away. As a standalone business with revenues, you know, for this part of our business is, you know, $61.3 million. Most of that revenue, we don't have a sales force. We don't have 100 people calling up people. We're not putting fancy ads on the Super Bowl. That means instead of spending that money, we're using that money to run our business and to minimize dilution, and to accelerate the programs so that we, you know, that we have become a major player in breast cancer and prostate cancer. Of course, COVID, we think now that the dust is settled and the Omicron variant is here, it humbles us that this is not going away. As much as business wants COVID to go away and we can reopen, it looks like it's gonna be tough. I mean, it's scaring people, okay? When you have that kind of fear, that means we do not have control over it. If we don't have control over it, we need to continue doing what we're doing, fight our way through getting the study done so that if we become an important option, you know, that we can move that quickly to patients. Okay. Back to the guidance. We're putting in a direct-to-patient portal. That means we have evolved from a purely, you know, manufacturer providing to other telemedicine portals to actually having our own portal. It does kind of change the valuation of the base business because instead of being a manufacturer that depends on customers that have their own portals, we'll have our own portal. You know, our competition out there is the male condom business. In the male condom business, the female condom business is about less than 1% of that market share. It is a tremendous blue ocean out there for us. With that size blue ocean, you know, there's room for a lot of portals to be out there to serve and to bring this product forward. Again, you know, our track record shows there's a market. We wanna feed into that market directly because if the female health business Urev has its own telemedicine portal, then that really opens us up to a lot of control over our destiny. The second thing we're doing is to continue to go out there and get additional telemedicine partners, because every time you turn around, there's another female contraception internet storefront or pharmacy that's opening up because that is such a big area of need. Because of COVID, again, women are not interested in, you know, going to the, you know, OB-GYN doctor or the primary care doctor, then having to go walk over to the CVS and then have to stand in line and then have to wait for the, you know, the medicine to come in and, you know, two days, three days later, go back to the CVS and then. It's just too many steps. They like to push the button, like they do the button for Amazon to get their Pellegrino water and push the button, and it shows up in their front door, front step. So that because of COVID, that is the reason why you're seeing such a surge in interest in telemedicine right now, because that has really created tremendous convenience, and we tap right into it. I think that's a lot of our success. We think that's all I can say about guidance, to get back to your question, as you know, we don't give guidance, but we do feel that we're going to have a better year in fiscal year 2022 than we did in 2021. We had a great year in 2021. That gives you a sense of some real resources that we can reinvest into our programs. Quite frankly, some of those resources are put into continuing to drive the robust growth. As it relates to the sexual health business, ENTADFI is in front of the FDA right now, and we're expecting to hear this month, and assuming we get approved, you know, we've already moved very quickly in creating a telemedicine portal. Again, separate from the female health business. We treat that like a standalone business. We're partnered with GoodRx. GoodRx spends $300 million-$400 million a year pulling people into their site. We're going to piggyback on that power and take advantage of that. Because, as you know, BPH is probably one of the main medicines that men will go in for men's health, particularly, you know, men over the age of 50. We can tap into that, take advantage of something. You know, GoodRx didn't even exist three years ago, four years ago. We're dealing with, you know, technologies and approaches to selling a product that just didn't exist five years ago, four years ago. We're tapping right into it with ENTADFI. The other thing we're doing with ENTADFI is we're not going to hire a marketing and sales force. We're just not going to go out there and get 100 people out there trying to sell to doctors. COVID doesn't let doctors into the offices anymore. I mean, it doesn't let salespeople into doctors' offices anymore. It's just become a new world. It's just an expense that we just don't have to spend. I'd rather use that money for drug development. With that said, there are opportunities for us also to partner ex-U.S. and in the U.S. for you know, other groups that are going to be interested in helping get this product out, kind of like we're doing with FC2. With FC2, it's not exclusive to us. We've got other, you know, very, very popular telemedicine portals that are helping us sell the product. We're going to kind of do the same thing with ENTADFI. Why not? It's not about, you know, trying to be exclusive in the doctor's offices anymore. I think we're going to have a very good year. Our expectation is that, you know, second half of the year will be stronger than the first half of the year because, you know, everything will be in place towards the second half of the year. We're looking for a good year. Okay. Well, thank you very much, Mitch. Thank you. The next question comes from Kumar Raja from Brookline Capital. Please go ahead. Thanks for taking my questions and also congratulations on all the progress. First, with regard to the COVID-19 trial, what kind of variability are you seeing across the different regions? Do you expect that predominantly these patients are going to have the Delta variant? Yeah. Make sure I understand the first part. What are we seeing across different regions in terms of strain? Death rate. Oh, death rate. It's pretty comparable. Yeah, yeah. It's, you know, obviously, you know, we're in the middle of recruitment, and we watch the, you know, the blinded data very closely, but we're seeing very similar, for instance, mortality rates in the United States versus Brazil. Yeah. I would say that that's the reason why the FDA likes to use death as an endpoint, because you can't fake a death. If a death happens, it's a pretty hard endpoint, and you're not worried about things like, you know, there may be different standard of care in hospitalizations or ICU stay in different countries, not because they're better or worse, but because, you know, if you have to make a decision who goes in the ICU, you may take somebody out of the ICU that in the U.S. would stay in the ICU because you don't have enough ICU beds and you got to just ration it. That has nothing to do with the virus. That's why death's probably the better endpoint. When you look at deaths as an endpoint, it seems to be comparable from region to region. As it relates to the strains, you know, interesting, I saw a recent graph where it looks like the Delta strain has become the predominant strain across the world. The other ones have kind of gone away. Now the big fear is this Omicron strain is coming in, and it's going to do the same thing. The only reason people are getting scared is because we already know with 30+ mutations in the S spike, in the spike protein, that, and we're already seeing Regeneron already, you know, reported and some of the other. I just saw a recent one with another antibody-directed drug. You know, we're gonna see that, you know, these monoclonal antibodies, they're going to very specific epitopes on the spike protein. If that epitope, if that spot is changed, the virus, the antibody is not going to work. We're seeing that now. you know, it is time for an oral agent that has more, think of it as sort of a broad-spectrum antibiotic concept. Where it's you know, it's gonna have you know, activity in some basic, very well conserved mechanism, which is how does a virus move from outside the cell into the nucleus, replicate, and get the new virions, the new viruses to come back out of the cell. I mean, that is highly regulated, highly conserved highway, the microtubules that they use. Whether you're a Delta strain or an Omicron strain, it doesn't matter. That's how they work. That's why I think, you know, we're in good shape. We are, you know, we are as part of determining whether they're COVID positive or not, we are getting information on what strain the patient has. We can go back once we get the data set and see whether or not there's differences from strain to strain, which we don't think we'll see. We are collecting that information. I would argue, I think most of the strain right now is Delta. Okay. With regard to TADFIN, have you had labeling discussions and what are your expectations in terms of the label? Thanks. Okay. In terms of TADFIN, just for the record, so people are clear, the FDA has agreed that if we're approved, the trade name will now be ENTADFI. I love TADFIN, but it turns out that the agency said there's another compound at the agency that could be confusing to use TADFIN. Because of that, they asked us to come up with another name, so we came up with ENTADFI. That's it. As it relates to the agency, what I can tell you at this point is we are, you know, going back and forth with the agency now on label. I can't give you a full statement yet in terms of what the label will say. We're working on that, so stay tuned. Thanks so much. Okay. Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks. Thank you, operator. I appreciate you all joining us today, and I look forward to updating you all on the progress at our next investor's call. Thank you. The digital replay of the conference call will be available beginning approximately noon Eastern Time today, December 2Nd, by dialing 1-877-344-7529 in the U.S. and excuse me, 1-412-317-0088 internationally. You'll be prompted to enter the replay access code, which will be 1016217. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.