Good morning, ladies and gentlemen, and welcome to Veru Inc’s Investor Conference Call. All participants will be in listen-only mode. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference 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 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'd now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc's Chairman, CEO and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer; Michele Greco, the Chief Financial Officer and CIO; Michael Purvis, Executive VP, General Counsel and Corporate Strategy; and Sam Fisch, 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, an internal condom for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The revenue from the sexual health division is being used to largely fund the clinical development of our late-stage drug candidate assets, which aim to address multi-billion dollar premium market opportunities. This morning, we will provide an update on the COVID-19 Sabizabulin and 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 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 III COVID-19 clinical trial, which was a double-blind multicenter, multinational randomized two to one placebo-controlled study evaluating a daily oral 9 milligram dose of Sabizabulin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients with 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-IL6 receptor antibodies and JAK inhibitors. 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. 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 were due to both the Delta and Omicron variants. The Independent Data Monitoring Committee conducted a planned interim analysis on April 8, 2022, in the first 150 subjects randomized in the Phase III COVID-19 study. After reviewing the unblinded clinical data, the committee unanimously recommended that the Phase III study be halted early due to clear clinical efficacy benefit. The committee 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, with an odds ratio of 3.23, 95% confidence interval of 1.45 to 7.22 with a p-value of 0.0042. The beneficial effects of Sabizabulin were observed starting as early as day three after dosing. And by day 15, statistically significant reductions in mortality were observed. The beneficial effects of Sabizabulin treatment on mortality were maintained to day 29, a standard time point for other studies that other studies have used as the efficacy endpoint, with a mortality rate of 35.2% for placebo compared with 16% for 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 only by 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 were observed regardless of standard of care treatment received. Additionally, Sabizabulin had an acceptable safety profile. The Phase III 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 hypertension. The Phase III 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 the FDA to discuss the next steps, including the submission of an emergency use authorization application. We were told by the FDA to submit the request for EUA. On June 6, we submitted a request for EUA to the FDA. As you know, there is no preset PDUFA date for a decision on a request for an EUA. We know the FDA is actively reviewing the application. We have received and have responded to several requests for additional information to aid their ongoing review. The FDA has conducted a successful pre-approval inspection of one of our manufacturing facilities and has audited two U.S. clinical sites with no adverse findings. They have scheduled audits of the clinical site in Bulgaria and one in Brazil, which should both be completed by the end of August. The 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 UK's Medicines and Healthcare Products Regulatory Agency considers that the currently available safety and efficacy data will support an expedited review of the marketing authorization application with the company's Sabizabulin treatment for 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 Emergency Task Force 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 that 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 indicated that Sabizabulin treatment reduces the number of deaths in these patients compared with placebo. We have made great progress in our discussions for advanced purchase agreements with government officials outside the U.S. We have scaled up manufacturing processes and should be able to produce commercial drug supply to address the anticipated drug needs following potential FDA authorization in the U.S. and potential subsequent authorizations and approvals in other countries. We have hired Joel Batten as Executive Vice President and General Manager of Veru's U.S. Infectious Disease Franchise effective May 23, 2022. Mr. Batten has been the head of the Respiratory Syncytial Virus franchise at Sobi North America, where he was responsible for a revenue of approximately $600 million and a team of over 160 employees. We are ready for the launch of Sabizabulin into hospitals and for granted emergency use authorization. We recently presented scientific results from the Phase III clinical program of Sabizabulin at the International Conference on Emerging Infectious Diseases in August 2022. As we can see, 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. Over 1 million Americans have died from COVID-19. We must reduce the risk of death in COVID-19 as vaccines alone are not enough. Antivirals like PAXLOVID and Molnupiravir target the non-hospital general population. Antivirals like Molnupiravir do not work in hospitalized moderate to severe COVID-19 patients. U.S. deaths in COVID-19 are averaging 500 deaths a day, and these patients are dying in hospitals. An effective and safe oral therapeutic treatment for hospitalized moderate to severe COVID-19 patients at high risk with ARDS that prevents deaths is desperately needed. We strongly believe that Sabizabulin, with its dual anti-viral 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 and Respiratory Syncytial Virus. Some of these planned clinical trials include a Phase III 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. As for our oncology drug portfolio focused on breast and prostate cancers, we're actively enrolling a global Phase III ARTEST registration trial evaluating enobosarm monotherapy for third-line treatment of AR positive, ER positive, HER2-negative metastatic breast cancer. We've also progressed enobosarm monotherapy into the second-line treatment for AR positive, ER positive, HER2-negative metastatic breast cancer. We're also conducting a Phase III multicenter open-label randomized active control registration ENABLAR-2 clinical study to evaluate the efficacy and safety of enobosarm and abemaciclib combination therapy against an alternative estrogen blocking agent. We have a collaboration and supply agreement with Lilly for this ENABLAR-2 study. Furthermore, our prostate cancer program is evaluating Sabizabulin for third-line treatment of metastatic castration-resistant prostate cancer in the Phase III VERACITY study. We are actively enrolling an open-label randomized Phase III VERACITY clinical study evaluating Sabizabulin 32 milligrams versus an alternative anti-receptor targeted agent for treatment of chemotherapy naïve men with metastatic castration-resistant prostate cancer. The primary endpoint is radiographic progression-free survival. Our second clinical trial in prostate cancer is evaluating VERU-100 in a Phase 2 dose-finding study for the treatment of hormone-sensitive advanced prostate cancer, which continues to show promising data. Veru has a commercial sexual health division called UREV, including two FDA approved products that allow broad market access to FC2 and ENTADFI. We are increasing U.S. public sector sales with our new agreements with distribution partnerships. We have launched ENTADFI, which is available for pharmacies to dispense and we are partnering with GoodRx to build awareness of ENTADFI. Overall, we have built the infrastructure to allow broad market access for FC2.

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 revenue 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. 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. Operating loss for the quarter was $21.8 million compared to $2.9 million in the prior year quarter. The bottom line results 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.

Thank you, Michele. In summary, we continue to advance our core late clinical stage breast and prostate cancer programs with three actively enrolling Phase III clinical studies and we expect substantial future revenue from Sabizabulin for hospitalized COVID-19 patients at risk for ARDS. Preparing for U.S. and global commercial launch of Sabizabulin has led to a transformative period in Veru’s history. We believe this will be an opportunity for significant near-term revenue for Veru.

At this time, we will begin the question-and-answer session. 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. Can you just elaborate on the order for these clinical sites and how typical of this is any sort of EUA approvals? Any indication at this stage that the two upcoming ex U.S. sites orders would be the last or do you believe the agency may look to continue to order additional facilities?

So it always relates to clinical sites. No indication that there will be additional audits of clinical sites after these. This is done under GACP. We have an excellent CRO called World Clinical Trials, and the impression that we get is that the FDA is checking their boxes as they go through this important review.

So first of all, our expectation is that the FDA, after they audit these two sites, does not indicate that they're going to be auditing additional sites. The FDA has been very clear on that.

This is generally a standard practice under NDA review where they go into these clinical sites and they pick the clinical sites for things like the number of patients that they put in the study.

How quickly can you get the product into the hospitals should you receive the EUA?

We believe if we get the EUA and we get the word, it will be between 9 to 14 days that we will have the drug available for dispensing in hospitals in the U.S.

Hi. Good morning, Mitch. Thanks for taking my questions. Could you provide an update on the inspection of other manufacturing facilities?

So to answer your question, we have three manufacturing facilities. We have the API facility, which has been audited and we do not believe will be further inspected by the FDA. The second facility put together the drug product and has also been recently audited. The third facility has not been inspected recently and was chosen for a pre-approval inspection, which went well.

How are discussions going for advanced purchase agreements for Sabizabulin considering the current situation?

There is a definite trend toward advanced purchase agreements as we engage with groups around the world for Sabizabulin. We are expecting multiple APAs triggered by the EUA authorization in the U.S. or by EMA and MHRA authorizations.

Has the UK MHRA already started reviewing the package for Sabizabulin?

We have submitted the data set for review and we are preparing the application for submission to the MHRA. They will begin the review process once we submit.

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.