Good morning, ladies and gentlemen, and welcome to Veru Inc's Investor Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the 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. Samuel 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 and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or 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 Dr. Gary Barnette, the Chief Scientific Officer, Michele Greco, the Chief Financial Officer and CAO, Michael J. Purvis, Executive VP, General Counsel, and Corporate Strategy, Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS related diseases, and for the management of breast and prostate cancers. The company has a commercial sexual health division called Urev, which includes two FDA-approved products, ENTADFI, a new treatment for benign prostatic hyperplasia, and the FC2 Female Condom, internal condom for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The revenue from the sexual health division is being used to largely fund the clinical development of our late-stage drug candidate assets, which aim to address multibillion-dollar premium market opportunities. This morning, we will provide an update on the COVID-19 sabizabulin clinical program and franchise, the clinical development of our oncology drug pipeline, and the commercialization of our products. We will also provide financial highlights for our third quarter of fiscal year 2022. First, I will update you on the status of our investigational drug candidate sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for ARDS. We conducted a successful Phase 3 COVID-19 clinical trial, which was a double-blind, multicenter, multinational, randomized two to one, placebo-controlled study evaluating daily oral 9 mg dose of sabizabulin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients who had high risk for ARDS and death. Both the placebo and sabizabulin treated groups were allowed to receive standard of care, which could include dexamethasone, remdesivir, anti-IL-6 receptor antibodies and JAK inhibitors. Moderate to severe COVID-19 infection patients were those who were hospitalized and required supplemental oxygen with at least one comorbidity, non-invasive ventilation, high-flow oxygen or mechanical ventilation. Furthermore, patients must have had a peripheral capillary oxygen saturation less than or equal to 94% at room air at hospital admission. The goal was to select patients at high risk for progression to ARDS and death. The primary endpoint was the proportion of patients who die on study up to day 60, not to day 29 like the other Phase 3 clinical studies reported in the literature. Having a primary endpoint at day 60 allowed us to capture a more accurate and potentially greater number of deaths caused by COVID-19 infection. Key secondary endpoints measured included the proportion of patients without respiratory failure, days in the ICU, days on mechanical ventilation, days in the hospital, and viral load. The study was conducted in the U.S., Brazil, Argentina, Mexico, Colombia, and Bulgaria, and the COVID-19 infections in the study included both the Delta and Omicron variants. On April 8, 2022, the Independent Data Monitoring Committee conducted a planned interim analysis in the first 150 subjects randomized in the Phase 3 COVID-19 study. After reviewing the unblinded clinical data, the Independent Data Monitoring Committee unanimously recommended that the Phase 3 study be halted early due to clear clinical efficacy benefit. The IDMC also remarked that no safety concerns were identified. In this interim analysis, sabizabulin treatment demonstrated a statistically significant 24.9 percentage point absolute reduction and a 55.2% relative reduction in all-cause mortality by day 60, which is the primary endpoint of the study, with an odds ratio of 3.23, 95% confidence interval of 1.45 to 7.22 with a P-value = 0.0042. The beneficial effects of sabizabulin were observed starting as early as day 3 after dosing, and by day 15, statistically significant reductions in mortality were observed. The beneficial effects of sabizabulin treatment on mortality were maintained through day 29, a standard time point that other studies have used as the efficacy endpoint. With a mortality rate of 35.2% for placebo compared with 16% for sabizabulin, which is an absolute reduction of 19.2 percentage points and a relative reduction of 54.5%. From day 29 to day 60, the death rate increased by 9.9 percentage points in the placebo group and by only 4.2 percentage points in the sabizabulin treated group, showing that the mortality benefit of sabizabulin was still clinically evident. This efficacy is further supported by the consistency of the mortality benefit across subgroup analyses of the primary endpoint. Clinically meaningful reductions in deaths with sabizabulin treatment compared to placebo was observed regardless of standard of care treatment received, baseline WHO ordinal score, sex, age, baseline comorbidities, BMI or geographic location. In the full overall final data set of 204 randomized patients, the all-cause mortality benefit was similar to the result observed in the interim efficacy analysis population, with sabizabulin treatment resulting in a 51.6% relative reduction in deaths compared to placebo treatment. In both the interim analysis efficacy and the overall 204 patient study groups, the key secondary efficacy endpoints demonstrated that sabizabulin treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared with placebo. Sabizabulin had an acceptable safety profile. Significantly fewer adverse and serious adverse events were reported for sabizabulin compared to placebo. There were also fewer treatment discontinuations due to adverse events in the sabizabulin group compared to placebo. The Phase 3 reported safety profiles suggest that sabizabulin treatment may have resulted in fewer COVID-19 related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock, and hypotension. The Phase 3 clinical trial interim efficacy and full study safety results were recently published in the New England Journal of Medicine Evidence online on July 6, 2022. We're now completing the final clinical study report for the overall study of 204 randomized subjects, and we plan to submit a manuscript of the full data set to a major peer-reviewed medical journal soon. On May 10, we had a pre-emergency use authorization meeting with FDA to discuss the next steps, including the submission of an emergency use authorization application. We were told by FDA to submit the request for EUA. On June sixth, we submitted a request for EUA to FDA. As you know, there is no preset PDUFA date to have a decision on a request for an EUA. We know FDA is actively reviewing the application. We have received and have responded to several requests for additional information to help their ongoing review. FDA has conducted a successful pre-approval inspection of one of our manufacturing facilities. FDA has also already audited two U.S. clinical sites with no adverse findings and has scheduled audits of a clinical site in Bulgaria and one in Brazil, which should both be completed by the end of August. FDA has informed us that our request for an EUA application is a high priority. Other major regulatory updates. On July 25, we announced that the United Kingdom's Medicines and Healthcare Products Regulatory Agency, the MHRA, considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application for the company's sabizabulin treatment in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome when the application is submitted. On July 27, we announced that the European Medicines Agency, EMA, Emergency Task Force, has informed the company that it has initiated the review of sabizabulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The Emergency Task Force's formal press release stated, quote, "The review will look at all available data, including data from a study involving hospitalized patients with moderate to severe COVID-19 who had high risk for acute respiratory distress syndrome and death. The results of this study, which is the New England Journal of Medicine Evidence publication, would indicate that sabizabulin treatment reduces the number of deaths in these patients compared with placebo. End quote. The review will assist the EU member states who may consider allowing use of the medicine before possible approval. This review is the first to be triggered under Article 18 of the new EU regulation that expanded the role of the EMA during public health emergencies. Not only have we subsequently submitted an application, but we also have had active discussions with the Emergency Task Force. We are also in various stages of discussion with regulatory agencies in other countries to obtain regulatory emergency or expedited authorization for sabizabulin. Furthermore, we have made great progress in our discussions for advanced purchase agreements with government officials outside the U.S. As for the commercial manufacturing status for sabizabulin drug product, we have scaled up manufacturing processes and should be able to produce commercial drug supply to address the anticipated drug needs following a potential FDA authorization in the U.S. and potential subsequent authorizations and approvals in other countries and territories. With sabizabulin U.S. commercial update, we have hired Joel Batten as Executive Vice President and General Manager of Veru's U.S. Infectious Disease franchise, effective May 23, 2022. Most recently, Mr. Batten has been the head of the respiratory syncytial virus, RSV franchise at Sobi North America, where he was responsible for the Synagis business with revenue of approximately $600 million and a team of over 160 employees. Mr. Batten led strategy for the RSV franchise as well as market access, distribution, and patient access services. Prior to Sobi, he spent approximately 20 years in a number of positions of increasing responsibility at AstraZeneca, MedImmune, and Sanofi-Aventis in the infectious disease franchises, including commercial infrastructure build-out, sales management, marketing, public health sales, and government affairs. He has put the core U.S. infectious disease commercial leadership in place. We have contracts executed for the commercial launch teams, market access, medical affairs, and distribution services for sabizabulin. We are ready for a launch of sabizabulin to hospitals if we're granted emergency use authorization. We recently presented scientific results in the Phase 3 sabizabulin clinical program at the International Conference on Emerging Infectious Diseases in 2022 in August 8 in Atlanta, Georgia. The presenter was Michael-- Dr. Michael Gordon, who's Chief Medical Officer at HonorHealth Research and Innovation Institute, Scottsdale, Arizona. Here we are. COVID-19 global cases, hospitalizations, and deaths are on the rise again with an unexpected summer surge. The emergence of serious COVID-19 variants BA.4 and BA.5 have led to this new surge, and these mutated strains have the ability to infect vaccinated patients. The White House warns that they expect over 100 million new cases in the fall and winter. Over 1 million Americans have died from COVID-19. We must reduce the risk of death from COVID-19. Vaccines are not enough. Antivirals Paxlovid and molnupiravir target the non-hospital general population who've experienced less than 5 days of symptoms with a narrow therapeutic window of opportunity. Paxlovid cannot prevent COVID-19 infections and is not effective in low-risk population. Antivirals like molnupiravir do not work in hospitalized moderate to severe COVID-19 patients. US deaths from COVID-19 are now averaging 500 deaths a day, and these patients are dying in the hospital. The death rate is unacceptable. It is clear that an effective and safe oral therapeutic to treat hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS that prevents deaths is desperately needed. We strongly believe that sabizabulin, with its dual antiviral and anti-inflammatory properties, can be that greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients as the new standard of care. We plan to initiate additional clinical studies to evaluate sabizabulin treatment in other populations at risk for death from COVID-19 infection and as a treatment for other viruses that cause ARDS, including influenza A virus, which causes up to 52,000 deaths and 710,000 hospitalizations each year, and respiratory syncytial virus, which causes 14,000 deaths and 177,000 hospitalizations each year in the US. These additional clinical studies, if successful, will allow us to expand sabizabulin into other large, serious infectious disease indications. Some of these planned clinical trials include a Phase three randomized placebo-controlled efficacy and safety study of sabizabulin for the treatment of severe... For the treatment of COVID-19 hospitalized patients who are WHO 3s, which means they're in the hospital, in trouble, but not on oxygen, and also the WHO 4s without the presence of a comorbidity. That allows us to approach the other 50% of patients that are hospitalized. Phase 3. The other trial is a Phase 3 randomized placebo-controlled efficacy and safety study of sabizabulin for the treatment of hospitalized patients with acute respiratory distress syndrome due to any viral illness. I will now briefly discuss the progress of our oncology drug portfolio that's focused on breast and prostate cancers. For patients with greater than or equal to 40% AR expression, we're actively enrolling a global Phase 3 ARTESS registration clinical trial in approximately 210 patients to evaluate enobosarm monotherapy for third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. We've also moved the enobosarm therapy earlier in the treatment sequence into second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancer. We are actively enrolling in a Phase 3 multicenter, open-label, randomized active-controlled registration ENABLAR-2 clinical study to evaluate the efficacy and safety of enobosarm and abemaciclib, combination therapy versus an alternative estrogen blocking agent in subjects with AR positive, ER positive, HER2 negative metastatic breast cancer who have failed first-line therapy with palbociclib which is a CDK4/6 inhibitor, plus an estrogen blocking agent who have greater than or equal to 40% AR expression in their breast cancer tissue. We plan to enroll approximately 186 subjects in this Phase 3 clinical study. We have a clinical trial collaboration and supply agreement with Lilly for this ENABLAR-2 Phase 3 clinical study. Under the terms of the non-exclusive clinical trial collaboration and supply agreement, Veru is responsible for conducting the clinical trial while Lilly is supplying abemaciclib for the study. Veru maintains full exclusive global rights to enobosarm. We've also made good progress in our prostate cancer program. Our first indication is evaluating sabizabulin for third-line treatment of metastatic castration-resistant prostate cancer in the Phase 3 VERACITY study. We have recently published in Clinical Cancer Research the clinical results of the positive Phase 1b/2 study of sabizabulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel androgen receptor-targeted agent. The summary of the results published was that the maximal tolerated dose was not reached in the Phase 1b, and the recommended Phase 2 dose was set at 63 milligrams a day. The most common adverse events, which is greater than 10% frequency at the 63 milligram oral daily dosing in the combined Phase 1b/2 data, were predominantly grade 1-2 events. Grade greater than 3 events included diarrhea at 7.4%, fatigue at 5.6%, and alanine aminotransferase and aspartate aminotransferase elevations of 5.6% and 3.7% respectively. Neurotoxicity and neutropenia were not observed. Preliminary efficacy clinical data in patients treated with greater than one continuous cycle of 63 milligrams or higher included an objective response rate in 6 of 29 or 20.7% of patients with measurable disease, which is one complete and partial responses, and 14 of the 48 or 29.2% of the patients had PSA declines. Most importantly, the Kaplan-Meier median radiographic progression-free survival was estimated to be 11.4 months in, with an N of 55 patients, and we had durable responses lasting greater than 2.75 years. These data support the ongoing Phase 3 VERACITY trial sabizabulin in men with metastatic castration-resistant prostate cancer. We're actively enrolling an open label randomized 2 to 1 multicenter Phase 3 VERACITY clinical study evaluating sabizabulin 32 milligrams 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 previously receiving at least one androgen receptor-targeted agent. The primary endpoint is radiographic progression-free survival. Enrollment for the Phase 3 VERACITY clinical study is on track, and we expect to enroll approximately 245 patients in 45 clinical centers in the U.S. Our second clinical study in prostate cancer is evaluating VERU-100, a GnRH antagonist three month depot formulation in a Phase 2 dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Although this study is ongoing, the preliminary clinical data continues to be promising. As you can see, we have an exciting and treatment paradigm changing late clinical stage oncology portfolio of drug candidates making great progress in advanced breast and prostate cancers. Veru has a commercial sexual health division called Urev, which includes 2 FDA-approved products FC2, for the dual protection against unplanned pregnancy and transmission of sexually transmitted disease infections, and the FDA-approved ENTADFI, tadalafil and finasteride capsule, a new treatment for benign prostatic hyperplasia, also known as BPH. We have built the infrastructure to allow broad market access to FC2 across the U.S. As a result, FC2 is now available through multiple sales channels. We have partnered with fast-growing, highly reputable telemedicine platform companies to bring our FC2 product to patients in a cost-effective and highly convenient manner. Our strategy to continue to drive FC2 sales is as follows. One, we will seek additional telemedicine Internet pharmacy service partners. Two, we created and launched our own dedicated direct-to-patient telemedicine Internet pharmacy services platform. This telemedicine platform is now up and running and is expected to be a new source of revenue. The website address is fc2condoms.com. Three, we've increased the U.S. public sector sales by our new agreements with distribution partnerships with Global Protection as well as Afaxys. We also have ENTADFI, an FDA-approved new treatment for benign prostatic hyperplasia. The most common side effects of currently prescribed BPH medicines are sexual adverse events, including impotence. ENTADFI has been shown to be faster and more effective for the treatment of benign prostatic hyperplasia than finasteride alone without causing impotence. I'm happy to report that we have officially launched ENTADFI and the product is available for pharmacies to dispense. We have partnered with GoodRx, a U.S.-based digital resource for healthcare to reach their almost 20 million monthly visitors, which includes both consumers and healthcare providers to build awareness about ENTADFI. There are over 45 million prescriptions filled annually for drugs to treat BPH. We plan to augment our own marketing and sales efforts by seeking additional partners in the U.S. and ex-U.S. I will now turn the call over to Michele Greco, CFO and COO, to discuss the financial highlights. Michele? Thank you, Dr. Steiner. As Dr. Steiner indicated, we have a lot of activity at Veru. Let's start our highlights with the third quarter results for the three months ended June 30, 2022. Overall net revenues were $9.6 million compared to $17.7 million in the prior year third quarter. The prescription business net revenues decreased from $13.5 million in the prior year third quarter to $6.7 million. The reduction is due to business challenges experienced by our telemedicine customers during the quarter, which resulted in a slowdown in orders during the current quarter. Global public sector net revenues were $2.9 million compared to $4.2 million in the prior year third quarter. The decrease in sales in the global public sector during the third quarter is due to the timing of tenders. In the prior year, we sold 2.8 million units to Brazil for tenders which have ended and therefore did not repeat in the current year. Gross profit was $7.1 million or 74% of net revenues, compared to $13.9 million or 79% of net revenues in the prior year third quarter. The reduction in gross profit and gross margin is driven primarily by the reduction in sales in our U.S. FC2 prescription business. Operating expenses for the quarter increased to $28.9 million compared to the prior year quarter of $16.7 million. The increase of $12.1 million is primarily due to research and development costs, which increased $6.9 million to $18.1 million compared to $11.2 million in the prior year quarter. The increase in selling general and administrative expenses of $5.2 million from $5.6 million to $10.8 million in the current period. The increase in research and development costs is due to the increased number of clinical trials. This quarter, we had 4 Phase 3 clinical trials and 2 Phase 2 clinical trials ongoing, while in the prior period we had 2 Phase 3 clinical trials and 2 Phase 2 clinical trials ongoing. The increase in selling general and administrative expenses is primarily due to the increase in headcount related to the preparations for the commercial launch of Vntafc and sabizabulin for COVID-19, resulting in increased compensation, increased stock compensation, and increased sales and marketing expenses. The operating loss for the quarter was $21.8 million compared to $2.9 million in the prior year quarter. Non-operating expenses were $234,000 compared to $2.7 million in the prior year third quarter, and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing. For the quarter, we recorded a tax expense of $138,000 compared to a tax benefit of $2.9 million in the prior year third quarter. The tax benefit recorded for the prior year quarter is primarily due to the increased value of the U.K. net operating losses due to an increase in the U.K. tax rates from 19%-25%. The bottom line result for the third quarter of fiscal 2022 was a net loss of $22.2 million or $0.28 per diluted common share, compared to a net loss of $2.7 million or $0.03 per diluted common share in the prior year third quarter. Turning to the results for the nine months ended June 30, 2022. For the first nine months of fiscal 2022, total net revenues were $36.8 million compared to $45.6 million in the prior year period. Net revenues from the U.S. prescription business were $29.9 million compared to $32.9 million in the prior year period. Net revenues for the global public health sector business was $6.9 million compared to $11.8 million in the prior year period. The reduction in the prescription net revenues is due to the business challenges experienced by our telemedicine customers in the third quarter. The decrease in sales in the global public sector during the period is due primarily to 9.7 million units sold to Brazil and 2.8 million more units sold to South Africa in the prior year period for tenders which have ended and therefore did not repeat in the current year. Overall, gross profit was $30.1 million, or 82% of net revenues, compared to $35.6 million or 78% of net revenues in the prior year period. The increase in gross margin is due primarily to the mix in sales, with the U.S. prescription business comprising a larger percentage of total net revenues. Operating expenses increased by $29.4 million to $68.6 million compared to the prior year period of $39.2 million. The increase is primarily driven by research and development costs, which increased by $19.3 million to $43.8 million from $24.4 million in the prior year period. The increase in research and development costs is due to the increased number of clinical trials which I discussed previously. Operating loss for the period was $38.6 million, compared to an operating income of $14.8 million from the prior year period. The change of $53.4 million is primarily due to the gain on sale of PREBOOST of $18.4 million in the prior year period. The increase in research and development costs during the current year period and the reduction in net revenues and gross profit which occurred during the third quarter. Non-operating expenses were $4 million compared to $5.9 million in the prior year period, and primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing. For the nine-month period, we recorded a tax expense of $225,000 compared to a tax benefit of $2.8 million in the prior year period. The company has net operating loss carryforwards for U.S. federal tax purposes of $38.8 million, with $29.7 million expiring in years through 2040 and $9.1 million, which can be carried forward indefinitely. Our UK subsidiary has net operating loss carryforwards of $63.5 million, which do not expire. The bottom line results for the first nine months of fiscal 2022 was a net loss of $42.8 million, or $0.53 per diluted common share, compared to net income in the prior year period, which included the gain on sale of PREBOOST of $11.7 million or $0.14 per diluted common share. Turning to our balance sheet. As of June 30, 2022, our cash balance was $100.6 million and our accounts receivable were $8.3 million. Our net working capital was $100.6 million on June 30, 2022, compared to $136 million at September 30, 2021. During the 9 months ended June 30, we used cash of $26.6 million for operating activities, compared with $14.8 million used for operating activities in the prior period. The expected future revenues from sabizabulin for COVID-19, the continued revenue from sales in the US FC2 prescription business and global public sector business, coupled with the expected future revenue from the launch of ENTADFI and added to our strong balance sheet, should continue to be the source of funds we use for commercial activities and to invest in our promising pharmaceutical clinical development programs as we continue to focus on developing novel medicines for COVID-19 and other viral and ARDS related diseases and for the management of breast and prostate cancers. Now, I'd like to turn the call back to Dr. Steiner. Thank you, Michele. In summary, we continue to advance our core deep, late clinical stage breast cancer and prostate cancer programs with 3 actively enrolling Phase 3 clinical studies. We have significant revenue generated from our base sexual health business. If authorized, we expect to have substantial future revenue, sabizabulin 9 milligrams for hospitalized COVID-19 patients at risk for ARDS. Being opportunistic and successful in developing sabizabulin to COVID-19 has led to the most eventful and transformative period in Veru's history. We are preparing for the U.S. and global commercial launch of sabizabulin 9 milligrams for the treatment of hospitalized mild to severe COVID-19 patients who had high risk for ARDS. As you can see from our balance sheet, we have the resources for these launch activities in the U.S. and global if granted emergency use authorization. Again, we believe this will be an opportunity for significant near-term revenue for Veru. With that, I'll now open the floor, the call to questions. Operator? Thank you. Ladies and gentlemen, at this time, we'll 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 reenter the question queue. Once again, that is Star then one to rejoin the question queue. We will pause momentarily to assemble our roster. 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. Just from me, I guess first up, a multipart question. Can you just elaborate on the audit of these clinical sites and how typical this is in these sorts of EUA approvals? Any indication at this stage that the two upcoming ex-US site audits would be the last? Or do you believe the agency may look to continue to audit additional facilities? Then within that, were these facilities picked randomly, granted the FDA picked it, but just any commentary or, you know, are there any data outliers that may have driven the selection of these audits? Okay, make sure I understand the first question. Can you say it again? Related to clinical trials, you're talking about the new additional ones? The clinical sites. Oh, clinical sites. Yeah. No. Your first question. It's always about clinical sites. Okay. My bad, as they say. No, I don't. First of all, our expectation is that the FDA, after they audit these 2 sites, there's no indication that they're gonna be auditing additional sites. They've been pretty clear. As it relates to why they picked these sites, you know, there's no indication that any particular site has an issue. This was done under GCP. We have an excellent CRO called Worldwide Clinical Trials. The impression that we get is that the FDA is checking their boxes, as they go through this very important review. I see this as routine. I do have with me Dr. Gary Barnette, who's our Chief Scientific Officer. You wanna add a comment to that? Yeah. This is generally a standard practice under NDA review, where they go into these clinical sites, and they pick the clinical sites. The review team selects the clinical sites for things like the number of patients that they put in the study and that kind of thing. The two in the U.S. have been completed without any findings, adverse findings. The two outside, it does take a little longer for the FDA to schedule sites outside the United States for audit because of all of the political things that have to go on with that. We expect these sites to do very well in those audits. As Mitch mentions, we do not believe that there'll be any additional audits of clinical sites after these. Great. I appreciate the additional color. Maybe just should you receive an EUA, how should we think about how quickly you can get the product into the hands of the hospitals? Yeah, great question. We have done a lot of work thanks to the internal team and, you know, we've quickly assembled a team, but it's a robust team. For things that we can't do internally, i.e., we brought in sort of the chiefs, we're contracting out with very reputable groups. One of the things that we've also done is we've also signed up a very reputable and massive distribution wholesaler. 'Cause that's really the way the hospitals work. That's where you need to drop ship your product, and that distributor is the one that gets it to all the hospitals, and it's very routinely done and very efficiently done. The one that we picked also is a big player with government contracts as well. It's pretty robust. With that said, if we get, you know, the EUA, when we get the EUA and get the word go, we believe it'll be somewhere between 9-14 days that we will have the drug available for dispense in hospitals in the U.S. Thanks, Mitch. That's very helpful. Best of luck and congrats, Veru. Great. Thank you. The next question comes from Leland Gershell from Oppenheimer. Please go ahead. Hi. Good morning, Mitch. Thanks for taking my questions. Must be very busy days there at Veru. Few questions from me. First, just again, with respect to FDA activities heading into the EUA decision, you'd mentioned, there had been an inspection of one of the manufacturing facilities. If you could just remind us, how many others there may be, and if there have been inspections scheduled for those, and how critical those would be for the EUA, given that you already have one that's been inspected, and I've got a couple more. Thanks. Sure. To answer your question, essentially, there's really three buckets. We have the API, which is manufactured by Olon Ricerca, and they have a facility in Italy and in the US. Olon Ricerca has clearly been audited by the FDA on numerous occasions, and this is the same API group that makes molnupiravir for Merck. Usually the FDA doesn't go back to a site that's been recently inspected. They're happy. This site, we do not believe will be further inspected by FDA. The second facility is CoreRx, which is the group that puts together the drug product and puts it into capsules. That group is out of Clearwater, Florida, and they have eight commercial products, including our product and Tat-P. We know they've been recently audited and inspected, I should say. They did great. We're not expecting, you know, another audit, another inspection because they've just been recently inspected. We're not expecting FDA to go to that group. We have a packaging manufacturing facility called Alfina in the US. They have not been inspected by the FDA recently, and the FDA chose that site to do a pre-approval inspection. As I mentioned in my comments, that went well. From a manufacturing standpoint, I think we're set. Okay. Great. You know, with options for the most severe patients in the hospital at high risk, you know, with COVID-19 remaining limited and given the compelling Phase 3 data, wanted to ask, you know, as you have discussions with both private and public entities out there that would be interested in getting hold of sofosbuvir, can you comment on any interest in securing certain amounts up front? Could we see any ATAs, advanced purchase agreements or any other such agreement to secure supply of sofosbuvir and perhaps materializing before the EUA? To answer the question, just so we're clear, in the US, hospital-based COVID-19 products are handled differently than non-hospital-based COVID-19 products or vaccines. Vaccines and drugs like Paxlovid and molnupiravir, because it's Part D as in dog, Medicare, they're handled by government purchases that are then distributed by government. In the hospital setting, it's much more efficient to work through the hospital system. When you look at all of the hospital-based EUA drugs, they're managed by a DRG payment that, what they call an NCTAP, which is a new, basically a new technology, COVID technology, added payment through Medicare. They have all other kinds of sweeteners to help the hospitals deal with the complicated DRGs, treat complicated patients, COVID-19 patients that obviously the DRG alone is not gonna cover it. They have additional sweeteners. It seems to work. I mean, if you look at remdesivir, which is under the system last year, they brought in almost $4.65 billion in the system. I could see why, you know, why mess with the distribution system. By the way, that's part A as in alphabet. That means the hospitals. This is an important point. That means that the hospitals have to seek reimbursement, not the company. The company provides product to the wholesaler, and we do that, we book the sale. The wholesaler sells it into the hospital, the hospital gets their reimbursement for the DRG, not for the drug itself. You know, once it leaves our hands, then we can book it. It's a very interesting system. Ex-US, however, there is, I mean, in ex-US, there is definitely an advance purchase agreement system where government, whether it's hospital-based or whether it's, you know, out of the hospital, non-hospital based, they buy. As I said in my comments, we have been contacted and we have been in active discussions literally across the world with groups that are getting ready to understand the drug, to understand how much they wanna purchase. You know, we're working through that, like as I said, across the world. What's also interesting about that is that it's starting to give us an indication a little bit about demand so that we can, you know, make sure that we've made enough for the world. We will have to allocate as we get into the next year. We will catch up. One of the things that's sort of an interesting wrinkle is that Europe, which has this expanded Article 18, was a little bit of a surprise to us because we didn't really know what the hell Article 18 was. Article 18 turns out to be a very, very important article, 'cause in January of 2022, the EMA recognized they needed something similar to an EUA. Consequently, they allow the emergency task force to come up with a preliminary opinion that would allow and provide cover for the 31 member states of the EU to basically order directly from Veru. That would mean a separate contract with each country that's interested in buying the product, which, as you know, is a different strategy than if you were gonna launch commercially in Europe. You typically pick certain countries to launch and that kind of stuff. This is really different. that has been triggered and we're in active discussions with the emergency task force in EU. Same thing with MHRA. We've also been in discussions with other groups that have set up either expedited or provisional type processes. It does feel different. I mean, this is the world's preparing for the emergency. They're starting to see the summer surge. They're concerned about the winter and the fall and the winter coming up. For example, in Korea, which is public information, you know, Korea has said publicly in their newspapers they're reviewing sabizabulin. Korea is the tenth-largest economy. South Korea, the small country of 50 million people, are starting to see about 110,000 new cases of COVID-19 a day. Their hospitalization rates are going up and their death rates are going up, and they're very worried. When we speak to them, they're always wearing masks. They have kept their masks on. We are expecting, I think it's fair to say we are expecting, APAs from multiple locations around the world, territories and countries. However, I think it's clear to say that many of these APAs are gonna be triggered by either the EUA authorization in U.S., EMA authorization, emergency use authorization, or an MHRA authorization. They're looking for cover in one of those three agencies. I think that's clear. You know, will we have one-offs with certain agencies that do their own work? I'm just getting the impression now, going through this, that they really look to the FDA and they look to the EMA, and they look to MHRA, that used to be part of the EMA, for guidance. Any one of those three, it'll open up the 80% of countries that are out there that are interested in getting the drug. With that Phase 2 having been in, you know, up and running for some time, thought we may see data from that trial around this time. Just wondering if you could just share any thoughts or expectations as to when we may see the data from that study of VERU-100. Thanks. Yeah, yeah. VERU-100 continues to go well. The challenge there is it turns out the reason nobody else has figured it out, because it's very complicated biologically. You have to. It turns out for GnRH antagonist that you give as a depo, you have to have a certain level to cause the castration, and you have to have another blood level that maintains that castration. They're different. We're asking a single injection to do both. I'm happy to report we can do that. Now we're just optimizing the dose, and I feel very confident that this is gonna be a very interesting product for prostate cancer because, you know, we know the agonists have their issues, and so we can have an antagonist that can go beyond one month. We have patients clearly beyond one month and, you know, approaching, we have some that approach three months. That's why I said in my comments as promising, but we're optimizing so that this way, when we go to the 100 patients in the Phase 3, every one of those patients will castrate immediately and maintain their castration for three months. Sit tight. I'll be able to provide more clarity, I hope, over the next few weeks. Okay, thanks for taking the question. Thank you. The next question comes from Chris Howerton from Jefferies. Please go ahead. Great. Thanks so much for taking the questions. I guess two from me. One would be with respect to the kind of distribution and government assistance with respect to COVID-19 in the United States. I guess, how should we be thinking about the status of the public health emergency and, you know, what are some of the influences that we can expect in terms of the categorization of those things and the viability of path forward for the EUA and those reimbursement parameters that you discussed earlier, Mitch? Then- Sure. The second question that I have would be related to your capital strategy. Obviously, the female condom business has been excellent and certainly cash producing. A little bit of a slowdown that we detect this quarter. Just wondering if you have any updates in terms of prioritization, in terms of cash deployment, given that observation. Yes. All right. Let me answer the first question. The first question is basically, that's great. You've got these sweeteners in the hospital setting. It works for remdesivir and other hospital-based products. Essentially, what you have is a DRG that has an outlier payment, has a 20% sweetener for COVID, and then on top of that, you have this NCTAP, which is a COVID added payment that also provides more resources so that hospitals can, you know, get close to 75% plus covered. And that's wonderful. I'm glad we have that. But the question is, it works. What happens when the emergency goes away? First of all, the first fact is that these programs will stay in place until the end of that calendar year. If we're going into the fall and the winter, and we're commercializing the product, the programs will stay in place until the end of that calendar year. If it turns out that the emergency is then pushed into the next year, you know, we've been in this for two and a half years, and it just doesn't feel like it's going away, and the death rate's pretty close to what it's been year one, year two, it feels like it'll continue, then that'll mean if it goes into January of next year, then they'll be required to pay until the end of January of 2023. The reason they do that is there are other programs that you can transition into. Like instead of NCTAP, this is called NTAP. NTAP has been in place, and again, it's new technology added payment, and NTAP will only work if you have a full approval. What we'll be doing full approval through an NDA. Obviously, what we'll be doing after the EUA is have a meeting with FDA for a pre-NDA meeting, and the pre-NDA meeting will allow us to find out what are some of the additional information we need for labeling, et cetera, that will allow us to go from an emergency use authorization to a full approval. The full approval will then allow us to trigger the NTAP and some of those payments. There is a strategy to allow us to continue to see robust reimbursement. As it relates to the capital strategy, yes, we saw a slowdown in FC2. It reminded us why it's important for us not to be reliant on customers, and that's why we created our own direct-to-consumer portal. I think it was a timely move on our part 'cause it takes time, and it's in, and it's working. It feels good 'cause we're seeing revenue coming in from that portal, and it allows us to be in control of our own destiny as it relates to getting capital. In addition to full expectation based on our communications with our customers that the, you know, the whole telemedicine group across the board got hit as people have transitioned from staying at home to going back out and going back home probably at some point. It's turning around and we're expecting fourth quarter to be better and next year to be even better. With that said, you know, anything can happen, but that's the signals that we're seeing. Our own portal allows us to have control. NTAP is completely new revenue. As I've said in my comments, we are in, you know, we are in discussions with a large telemedicine group that can help us with that. Plus, you know, we're moving very actively with GoodRx and market access. This is an easy one to sell. If you talk to urologists about ENTADFI, which is a combination of erectile dysfunction medicine and a medicine that shrinks the prostate, but it shrinks the prostate faster and more effectively than Finasteride alone, they get it, and they all. I think this will be, again, another source of revenue. With that said, you know, the reason we still have $100 million in the bank, and we raised that money almost 18 months, 20 months ago, is because we've been able to match our spend with the money we bring in. We know the levers to pull. We would do the same thing. We're not waiting for revenue to catch up. We're managing our business so that we can be efficient in clinical trial recruitment and getting, you know, to commercialization. But there again, as you mentioned, we have to prioritize. At this point now, we're focused highly on the enobosarm in a second-line setting, in a third-line setting. We have the VERACITY study going. It's Phase three recruiting. VERU-100 is one of those that is just such an established market that once we can get there, that can be a nice cash cow. In the meantime, if the emergency use authorization is granted and we get resources when we drop ship product to the distributor, and we're not worrying about reimbursement 'cause that's not our, that's not what we do. It's not like, you know, Part D, where you wait for the prescription to be filled. In this situation, you know, once it goes into the wholesaler, we can get the money. Then there is a real opportunity to see significant revenue within, you know, two weeks or so from the time we get the EUA, which means that, we'll have the capital to continue the new Phase 3 studies for COVID-19 and, to, you know, to maintain our business and to become profitable. You know, we still have the fundamental company in place. We have a core oncology business that's doing great. We have the resources to match the spend. Even with the extra spend, as you heard from Michelle, getting ready with the COVID-19 infectious disease franchise, we've done very well to, you know, have those resources ready to go, and we didn't have to do a raise and dilute. I think we've done a good job managing our finances. I would agree. Thank you so much, Mitch, for taking the questions, and congratulations. Thank you. Again, if you would like to ask a question, please press star then one, and to withdraw your question, press star then two. Our next question comes from Yi Chen from H.C. Wainwright. Please go ahead. Thank you for taking my question. Just to clarify, has the UK MHRA already started reviewing package for sabizabulin? To clarify, what we do first, the way the process works, is you have to meet with their COVID-19 task force. We have to submit the materials to begin that process. When we met with them, as we said in the press release, they were so excited about the medicine, that the entire task force basically said, "You know, you submit," 'cause there's a process in the MHRA, "You submit, and we're gonna support it for expedited review." They're the only ones that can do that. However, Right. You have to submit. What we were waiting for before we submit to the U.K. is the entire dataset for all 204 patients, which we've now received. As we speak now, the application's being prepared for submission. Then they can start the clock. Once they start the clock, the clock is unclear at this point, but once we have more clarity, I'll be able to share that with you. That's in place. The UK MHRA's review process and EMA's review process are completely independent from FDA's EUA review process, correct? They will not wait for FDA's decision to affect their own. Yeah. Reviewing decision, right? If you look at the emergency use authorizations for molnupiravir, it turned out that the MHRA had the emergency use authorization done before the U.S. They are very independent. Just to be very clear, MHRA is independent, EMA is independent, FDA is independent. If any one of those three organizations authorize sabizabulin, then about 80% of the countries in the world will take that as a trigger to authorize it in their country. Got it. Thank you. Ladies and gentlemen. Okay. Oh, sorry. 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. I appreciate you joining us on today's call. I look forward to updating you all on our progress in our next investors call. Thank you.