Q3 2022 Veru Inc Earnings Call

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Good morning, ladies and gentlemen, and welcome to Varian, Inc. 's Investor Conference call. All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After this mornings discussion there'll be an opportunity to ask questions. Please note that this event is being recorded.

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.

I think it was a timely move on our part because it takes time, and it's in, and it's working.

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.

It feels good because 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.

I would now like to turn the conference call over to Mr. Sam Fisch Ferro inks executive director of Investor Relations and corporate Communications. Please go ahead.

Please go ahead.

Good morning, the statements made on this conference call may be forward looking statements.

Good morning.

In addition to full expectation based on our communications with our customers, 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. But it's turning around, and we're expecting fourth quarter to be better and next year, to be even better.

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.

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 the dominant product portfolio.

Such forward looking statements are subject to known and unknown risks uncertainties and our actual results may differ significantly from those projected suggested or included in any forward looking statements.

Risks that may cause actual results or developments that differ materially, are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time.

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.

That said, anything can happen, but that's the signals that we're seeing, and our own, portal allows us to have control.

I would now like to turn the conference call over to Dr. Mitchell Steiner <unk>, Chairman CEO and President Good morning, with me on this morning's call a doctor Gary Barnett, She Chief Scientific Officer, Michele Greco the Chief Financial Officer, and C. E O micro purpose executive VP General counsel and corporate strategy and Sam.

Entadfi is completely new revenue, and as I've said in my comments, we are in discussions, with a large telemedicine group that can help us with that.

Good morning.

With me on this morning's call are Dr. Gary Barnett, the Chief Scientific Officer, Michelle Greco, the Chief Financial Officer and CAO, Michael Purvis, Executive VP, General Counsel and Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications.

Plus, we're moving very, very actively with GoodRx and market access, and this is an easy, one to sell, but it shrinks the prospect faster and more effectively than financed by the loan, they get it, and I think this will be, again, another source of revenue.

Fish.

<unk> director of Investor Relations and corporate communications. Thank you for joining our call.

Thank you for joining our call.

With that said, you know, the reason we still have a hundred million dollars 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.

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.

So we know the levers to pull, and, so we would do the same thing.

<unk> is a biopharmaceutical company focused on developing novel medicines for COVID-19, and other viral and E. R. D S related diseases and for the management of breast and prostate cancers. The company has a commercial sexual health division called you graph, which includes two FDA approved products and Kathy and new treatment for benign.

The company has a commercial sexual health division called UREV, which includes two FDA-approved products, TADFI, 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.

Prostatic hyperplasia and the F C. Two female condom internal condom with a 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.

So 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 to commercialization.

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, so busy Beulah and clinical program and franchise the clinical development of our oncology drug type.

This morning, we will provide an update on the COVID-19 Subisubulin Clinical Program and Franchise, the clinical development of our oncology drug pipeline, and the commercialization of our products.

But again, as you mentioned, we have to prioritize.

Flying and the commercialization of our products.

We will also provide financial highlights for our third quarter of fiscal year 2022.

We will provide financial highlights for our third quarter fiscal year 2022.

First, I will update you on the status of our investigational drug candidate Subisubulin, 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 2-to-1, placebo-controlled study evaluating daily oral 9-milligram doses of Subisubulin for up to 21 days versus placebo in 204 hospitalized moderate-to-severe COVID-19 patients who were at high risk for ARDS and death.

So at this point now, we're focused highly on the NOBIS arm in a second-line setting and a third-line setting.

First I will update you on the status of our investigational drug candidates are busy people and for the treatment of hospitalized COVID-19 patients at high risk for a R. D S.

Both the placebo and Subisubulin treated groups were allowed to receive standard of care, which could include dextromethazone, remdesivir, anti-IL-6 receptor antibodies, and JAK inhibitors.

We have the veracity study going.

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 daily oral nine milligram doses. So basically you and fill up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19.

It's phase three recruiting, and Vera 100 is one of those that is just such a, established market that once we can get there, that can be a nice cash cow.

19 patients who had high risk with a R D S and death.

The placebo into busy Beulah untreated groups were allowed to receive standard of care, which could include dexamethasone when desert here anti anti IL six receptor antibodies and JAK inhibitors.

Moderate to severe COVID-19 infection patients are those who were hospitalized and required, supplemental oxygen with at least one comorbidity, non-invasive ventilation forced oxygen, or mechanical ventilation. Furthermore, patients must have had a peripheral capillary oxygen saturation less than or equal, to 94% at room air and hospital admission. The goal was to select patients at high risk for progression to ARDS and death.

Moderate to severe COVID-19 infection patients those who are hospitalized and required supplemental oxygen with at least one coma bit co morbidity.

Non invasive ventilation force oxygen or mechanical ventilation. Furthermore, patients must have had a peripheral capillary oxygen saturation less N equals a 94% at room Air and hospital in Michigan. The goal was to select patients at high risk for progression to a R. D S and death.

The primary endpoint, which are a portion of patients who die on study up to day 60, not to date 29 like the other phase III clinical studies reported in the literature, having a primary endpoint of day 60 allowed us to capture even more accurate and potentially greater number of deaths caused by COVID-19 infection.

The primary endpoint was the proportion of patients who die on study up to day 60, not, to day 29 like the other phase three 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 proportionate patients without respiratory failure days in the ICU days on mechanical ventilation days in the hospital and viral load.

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.

That he was conducted in the U S, Brazil, Argentina, Mexico, Colombia in Bulgaria, and the COVID-19 infections. In this study who did both the Delta and Omar Khan variance.

On April 8, 2022, the Independent Data Monitoring Committee conducted a planned interim analysis, in the first 150 subjects randomized in the phase three COVID-19 study. After reviewing the unblinded clinical data, the Independent Data Monitoring Committee, unanimously recommended that the phase three study be halted early due to clear clinical efficacy benefit. The IDMC also remarked that no safety concerns were identified. In this interim analysis, sub-isobutylene 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, a 95% confidence interval of 1.45 to 7.22, with a p-value equals 0.0042.

April 8th 2022.

The independent data monitoring committee conducted a planned interim analysis in the first 150 subjects randomized in the phase III COVID-19 study after reviewing the unblinded clinical data the independent data monitoring committee unanimously recommended that the phase III study would be halted or.

Early due to clear clinical efficacy benefit the I D. M. C. Also remark that no safety concerns were identified in this interim analysis. So busy bulent treatment demonstrated a statistically significant 24.9 percentage point absolute reduction and a 55.2% relative.

A reduction in all cause mortality by day 60, which is the primary endpoint of the study with an odds ratio of three point to 395% confidence interval 1.45 to seven point to too with the P value equals 0.0042.

The beneficial effects of Sip is appealing but were observed starting as early as day three after dosing and by day 15 statistically significant reductions in mortality were observed the beneficial effects, which are busy people and treatment of mortality were maintained through day 29, a standard time point for other studies that others.

The beneficial effects of sub-isobutylene 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 sub-isobutylene 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 sub-isobutylene, which is an absolute reduction of 19.2 percentage points and a relative reduction of 54.5%.

Studies have used as the efficacy endpoint with a mortality rate of 35, 2% for placebo compared with 16 for San Francisco's you're viewing 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 sub-isobutylene-treated group, showing that the mortality benefit of sub-isobutylene was still clinically evident. This efficacy is further supported by the consistency of the mortality benefit across, subgroup analyses of the primary endpoint. Statistically meaningful reductions in deaths with sub-isobutylene 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.

And day 29 today 60, the death rate increased by 9.9 percentage points in the placebo group and by only 4.2 percentage point, indeed, so busy people and treated group showing that the Motown mortality benefit it's a busy viewing was still clinically evident.

This efficacy was further supported by the consistency of the mortality benefit across subgroup analyses of the primary endpoint.

Clinically meaningful reductions in deaths was so busy bulent treatment compared to placebo was observed regardless of standard of care treatment received baseline W. H O ordinal score sex age baseline Comorbidities BMI, what 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 subisobutylene 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 subisobutylene treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared with placebo.

In the full overall final dataset of 204 randomized patients.

All cause mortality benefit was similar to the results observed in the interim efficacy analysis population with so basically you and treatment, resulting in a 51, 6% relative reduction in deaths compared to placebo treatment.

And both the interim analysis efficacy and the overall 204 patient study groups.

Key secondary efficacy endpoints demonstrating this visit Beulah treatment resulted in a significant reduction in days in the ICU days on mechanical ventilation days in the hospital compared with placebo.

So visit Bulent had an acceptable safety profile.

Subisobutylene had an acceptable safety profile. Significantly fewer adverse and serious adverse events were reported for subisobutylene compared, to placebo. There were also fewer treatment discontinuations due to adverse events in the subisobutylene, group compared to placebo. The Phase III reported safety profiles suggest that subisobutylene treatment may have resulted, in fewer COVID-19-related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock, and hypotension.

Significantly fewer adverse and serious adverse events were reported chrissy busy people and compared to placebo. There were also fewer treatment discontinuation due to adverse events in this busy bulent group compared to placebo.

As III reported safety profiles suggests it's a busy people and treat me may have resulted in fewer COVID-19 related morbidities, especially respiratory failure pneumothorax acute kidney injury cardiac arrest septic shock and hypotension.

The phase III clinical trial interim efficacy and full study safety results were recently published in the New England Journal Medicine evidence online on July six 2022.

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 dataset to a major peer-reviewed medical journal soon.

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 false dataset to a major peer reviewed medical journal soon.

On May 10th we had a pre emergency use authorization meeting with F. D. A to discuss the next steps, including the submission of an emergency use authorization application. We were told by F. D. A to submit the request for EUA.

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 6, we submitted a request for EUA to FDA.

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 because that's not what we do.

On June six we submitted a request for EUA to F. D. A as you know there is no preset producer date to have a decision on our 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.

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.

U F. D. A has has conducted a successful pre approval inspection of one of our manufacturing facilities F. D. A is also already audited two U S clinical sites with no adverse findings and has scheduled the audits of our clinical site in Bulgaria, and one in Brazil, which should both be completed by the end of <unk>.

August FDA has informed us that a request for an EUA application is a high priority.

Other major regulatory updates on July 25th we announced that the United Kingdom's medicines and healthcare products regulatory agency. The M. H R. E considers that the currently available safety and efficacy data will support and expedited review of the marketing marketing authorization application with the company so busy people in treatment.

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 subisubulin 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 has initiated the review of subisubulin for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.

Hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, when the application is submitted.

On July 27th we announced that the European Medicines agency.

Hey.

Emergency Task Force has informed the company that has initiated the review so busy bulent for the treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The emergency task forces formal press release stated quote the review we will look at all available data, including data from a study involving.

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 are at 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 subisubulin treatment reduces the number of deaths in these patients compared with placebo, end quote.

Hospitalized patients with moderate to severe COVID-19, who had high risk for acute respiratory distress syndrome and that the results of this study, which is the new England Journal of Medicine, evidenced publication would indicate that's the busy bulent treatment reduces the number of deaths in these patients compared with placebo and close.

The review will assist the EU member states who may consider allowing use of the medicine, before possible approval. The 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.

The review will assist the EU member States, who who mean, who may consider allowing use of the medicine before possible approval. The review as it first this review was the first to be triggered under article 18 of the new EU regulation.

That expanded the volt he made during public health emergencies, not only have we subsequently submitted an application, but we have also we also have active discussions with the emergency task force.

Not only have we subsequently submitted an application, but we have also had active discussions, with the Emergency Task Force. We are also in various stages of discussion with regulatory agencies and other countries, to obtain regulatory emergency or expedited authorization for Subizubulin.

We are also in various stages of discussion with regulatory agencies in other countries to obtain regulatory emergency actually that authorization was so busy bulent. Furthermore, we have made great progress in our discussions for advanced purchase agreements with government officials outside the U S.

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 Subizubulin 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.

That's where the commercial manufacturing status, which are busy people and drug product, 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 and territories.

Yeah.

We're so busy Beulah and U S. Commercial update we have hired Joe bat, Joe Baton as executive Vice President and general manager of various U S. Infectious disease franchise effective may 23rd 2022, and most recently Mr. Batten has been the head of the respiratory syncytial virus RSV franchise and still be North America.

With Subizubulin 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 Sobey North America, where he is responsible for the Synergist 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.

Where he was responsible for the Synergist 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 sobey. He spent approximately 20 years in a number of positions of increasing responsibility at ash.

Prior to Sobey, he spent approximately 20 years in a number of positions of increasing, responsibility at AstraZeneca, MedImmune, and Sanofi Advantis in the virus infectious disease franchises, including commercial infrastructure build-out, sales management, marketing, public health sales, and government affairs.

Zeneca, Medimmune and Sanofi Aventis in the virus and 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 con contracts executed for the commercial launch teams market access medical affairs and distribution services, which are busy people and we are ready for a launch of so busy bulent to hospitals if were granted emergency use authorization.

He has put the core U.S. infectious disease commercial leadership in place.

We have contracts executed with commercial launch teams, market access, medical affairs, and distribution services for Subizubulin.

We are ready for a launch of Subizubulin to hospitals if we're granted emergency use authorization. We recently presented scientific results in the Phase III Subizubulin Clinical Program, at the International Conference on Emerging Infectious Diseases in 2022 on August 8th in Atlanta, Georgia.

We recently presented scientific yourself in the phase III <unk> clinical program at the International conference on emerging infectious diseases 2022 and August 8th in Atlanta, Georgia. The presenter was Michael Dr. Michael Gordon Who's Chief Medical Officer Honor Health Research Innovation Institute Scottsdale, Arizona.

The presenter was Dr. Michael Gordon, who is Chief Medical Officer at Honor Health Research, Innovation Institute, Scottsdale, Arizona.

So here we are covered.

So here we are.

It's not like part D, where you wait for the prescription to be filled.

In this situation, once it goes into the wholesaler, we can get the money.

COVID-19 global cases, hospitalization, and deaths are on the rise again with an unexpected, summer surge. The emergence of serious COVID-19 variants, BA4 and BA5, have led to this new surge, and, these mutated strains have the ability to infect vaccinated patients.

COVID-19, global cases, hospitalization and deaths on the rise again with an unexpected summer surge the emergence of serious COVID-19 variance be a four and be a five have led to this new surge and these mutated strains have the ability to infect vaccinated patients the whitehouse warrants that they expect over 100 million.

Then there is a real opportunity to see significant revenue within two weeks or so from the time we get the EUA, which means that we'll have the capital to continue the new phase three studies for COVID-19 and to maintain our business and to become profitable.

The White House warrants that they expect over 100 million new cases in the fall and, winter.

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.

One minute well over 1 million Americans have died from COVID-19, we must reduce the risk of death and COVID-19 vaccines are not enough antivirals packs of love with them on the peer of your target. The non hospital general population who've experienced less than five days of symptoms with a narrow therapeutic window of.

Vaccines are not enough.

Antivirals, Paxilovid, and Molnupiravir target the non-hospital general population who've, experienced less than five days of symptoms within a narrow therapeutic window of opportunity.

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Paxillobid cannot prevent COVID-19 infections and is not effective in low-risk populations.

That's a lovely cannot prevent COVID-19 infection and is not effective in low risk population antivirals like molded peer of your do not work in hospitalized moderate to severe COVID-19 patients.

Antivirals like molnupiravir do not work in hospitalized moderate to severe COVID-19 patients.

U.S. deaths from COVID-19 are now averaging 500 deaths a day and these patients are dying in the, hospital.

U S. That's in COVID-19, and 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 had high risk with Rds. It prevents deaths is desperately needed.

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 subizabulin 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 strongly believe that it's a busy bulent with its dual anti viral and anti inflammatory properties. It 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 subizabulin 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 U.S.

We plan to initiate additional clinical studies to evaluate so busy dealing treatment in other populations at risk for death from COVID-19 infection and as a treatment for other viruses that cause a R. D S, including influenza a virus, which causes up to 52000 deaths and 710000 hospitalizations each year.

In respiratory syncytial virus, which causes 14000 deaths and 177000 hospitalizations each year in the U S. These additional clinical studies of success, if successful will allow us to expand too busy people into other large serious infectious disease indications.

These additional clinical studies, if successful, will allow us to expand subizabulin to other large, serious infectious disease indications. Some of these planned clinical trials include a phase 3 randomized placebo-controlled efficacy and safety study of subizabulin 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.

Some of these planned clinical trials include a phase III randomized placebo controlled efficacy and safety study so busy viewing for the treatment of severe.

For the treatment of COVID-19, hospitalized patients, who are who threes, which means they're in the hospital with in trouble, but not on oxygen and also the who fours without the presence of a comorbidity.

And so that allows us to approach the other 50% of patients that are hospitalized.

And and so that allows us to approach the other 50% of patients that are hospitalized.

Phase III.

Phase 3, the other trial is a phase 3 randomized placebo-controlled efficacy and safety study, of subizabulin for the treatment of hospitalized patients with acute respiratory distress syndrome due to any viral illness.

Trial is a phase III randomized placebo controlled efficacy and safety study of say busy bulent 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.

So, 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, and 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 have those resources ready to go, and we didn't have to do a raise and dilute.

So, 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.

I will now briefly discuss the progress of our oncology drug portfolio, that's focused on breast and prostate cancers.

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.

Perfect for patients with greater than equal to 40% of our expression.

For patients with greater than equal to 40% AR expression, we're actively enrolling a global phase 3 R-test registration clinical trial in approximately 210 patients who evaluate a novus arm monotherapy for third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. We've also moved the novus arm therapy earlier in the treatment sequence into second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancer.

Our next question comes from Yi Chen from H.C. Wainwright.

Actively involving a global phase III, our test registration clinical trial, and approximately 210 patients who evaluate the novus arm monotherapy for third line treatment of Arab positive ER positive her two negative metastatic breast cancer.

Please go ahead.

Thank you for taking my question.

Just to clarify, has the UK MHRA already started a reviewing package for, subsidies?

To clarify, what we do first, the way the process works, is you have to meet with their COVID-19 task force.

We've also moved to notebooks arm therapy earlier in the treatment sequence into second line treatment setting. They are positive you are positive or negative metastatic breast cancer.

So, we have to submit the materials to begin that process.

And so 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, because there's a process in the MHRA, you submit, and we're going to support it for expedited review.

We're actively enrolling in a phase III multicenter open label randomized active control registration, enabling two clinical study to evaluate the efficacy and safety for Novus arm and Alabama cycling a combination combination therapy versus an alternative estrogen blocking agent in subjects with Arab positive you are.

And they're the only ones that can do that.

We're actively enrolling in a phase 3 multi-sensor, open-label, randomized, active-control registration enabler 2 clinical study to evaluate the efficacy and safety of a novus arm and abemocyclib, a combination therapy versus an alternative estrogen-blocking agent. And subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer who have failed first-line therapy, with pablocyclib, which is a CDK4-6 inhibitor plus an estrogen-blocking agent who have greater than equal to 40% AR expression in their breast cancer tissue. We plan to enroll approximately 186 subjects in this Phase 3 clinical study.

However, you have to submit.

And so what we were waiting for before we submit to the UK is the entire data set for all 204 patients, which we've now received.

Positive her two negative metastatic breast cancer, who have failed first line therapy with Pablo cyclic which is a CDK four six inhibitor plus an estrogen blocking agents, who have greater than equal to 40% are expression of breast cancer tissue.

To enroll approximately 186 subjects in this phase III clinical study.

We have a clinical trial collaboration and supply agreement with Lilly for this enabled with two phase III clinical study under the terms of the non exclusive clinical trial collaboration and supply agreement bureaus responsible for conducting the clinical trial, what Lilly is supplying about a cycle for the study room maintains bull exclusive global.

We have a clinical trial collaboration and a supply agreement with Lilly for this Enabler, 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 a bene cycle for the study.

And so as we speak now, the application's being prepared for submission, and then they can start the clock.

Once they start the clock, and again, the clock is unclear at this point, but once we have more clarity, I'll be able to share that with you.

But that's in place.

So the UK MHRA's review process and EMA's review process are completely independent from FDA's EUA review process, correct?

Veru maintains full exclusive global rights to InnovaSign.

Rights to a nobu song.

We've also made good progress in our prostate cancer program.

We've also made good progress in our prostate cancer program.

Our first indication is evaluating Sip is appealing for third line treatment of metastatic castration resistant prostate cancer and the phase III veracity study.

Our first indication is evaluating subizabulin 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 1b2 study of subizabulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel angioreceptor-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.

We have recently.

Published in clinical cancer research clinical results of the positive phase one b two study so busy building and 80 men with metastatic castration resistant prostate cancer.

<unk> on at least one novel androgen receptor targeted agent summary of the results published was at the maximum tolerated dose was not reached in the phase <unk> and the recommended phase two dose was set at 63 milligrams a day.

The most common adverse events, which is greater than a 10 percent frequency at the 63 milligram, oral daily dosing in the combined Phase 1b2 data, were predominantly Grade 1-2 events.

Most common adverse events, which is great it's great and a 10% frequency at the 63 milligram oral daily dosing in the combined phase one b two data were predominantly grade one two events grade greater than three events included diarrhea at seven 4% fatigue at five 6% and alanine aminotransferase.

Graded-in-3 events included diarrhea at 7.4 percent, fatigue at 5.6 percent, and alanine, aminotransfer rates and aspartate aminotransfer rates elevations of 5.6 and 3.7 percent, respectively.

For age and the Spartiate aminotransferase transfer rates elevations of 5.6, and three 7% respectively.

Neurotoxicity and neutropenia were not observed. Preliminary efficacy clinical data in patients treated with Grade 1 continuous cycle of 63, milligrams or higher included an objective response rate in 6 of 29 or 20.7 percent of patients with measurable disease, which is one complete and five partial responses, and, 14 of the 48 or 29.2 percent of the patients had PSA declines.

<unk> toxicity neutropenia without observed preliminary efficacy clinical data in patients treated with greater than one continuous cycle of 63 milligram or higher including an objective response rate and six of 29, 27% of patients with measurable disease, which is one complete and five partial responses and 14th.

48, or 29, 2% of the patients had Psa declines.

Most importantly, the Kaplan Meier median radiographic progression free survival.

Most importantly, the Kaplan-Meier median radiographic progression-free survival was, estimated to be 11.4 months with an N of 55 patients, and we had durable responses lasting greater than 2.75 years.

Was estimated to be 11.4 months in with an N of 55 patients and we had durable responses lasting greater than 275 years.

These data support ongoing.

These data support the ongoing Phase 3 veracity trial subisibulin amin with metastatic castration-resistant, prostate cancer. So, we're actively enrolling an open-label, randomized 2-to-1, multicenter Phase 3 veracity, clinical study evaluating subisibulin 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 ongoing phase III veracity trials visibility of men with metastatic castration resistant prostate cancer. So we're actively enrolling an open label randomized two to one multicenter phase III veracity clinical study evaluating so busy people and 32 milligrams versus an alternative androgen receptor targeted agent for the treatment.

Chemotherapy naive men with metastatic castration resistant prostate cancer, who have had to tumor progression. After previously receiving at least one androgen receptor targeted agent that primary endpoint as radiographic progression free survival.

The primary endpoint is radiographic progression-free survival.

And then for the Phase III veracity of clinical study is on track and we expect to enroll approximately 245 patients at 45 clinical centers in the U S.

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 VIRU-100, a GnRH antagonist, three-month depot formulation, in a Phase 2 dose-binding clinical study for the treatment of hormone-sensitive advanced prostate cancer.

Our second clinical study in prostate cancers are valuing evaluating VB 100, Gnrh antagonist, three month depot formulation and a phase two 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.

Although this study is ongoing the preliminary clinical data continues to be promising as you can see we have an exciting entry.

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.

Our exciting and treatment paradigm changing late clinical stage oncology portfolio of drug candidates, making great progress and advanced breast and prostate cancers.

Veru has a commercial sexual health division called UREV, which includes two FDA approved, products, FC2, for the dual protection against unplanned pregnancy and transmission of sexually transmitted infections, and the FDA approved Entafi, Tadalafil and Finasteride capsule, a new treatment for benign prostatic hyperplasia, also known as BPH.

Bureau has a commercial sexual health division called Europe , which includes two F. D. A approved products F C too for the dual protection against unplanned pregnancy and transmission of sexually transmitted infections and the F D. A pud and tad feet, Tadalafil, and finasteride capsule and new treatment for benign.

Prostatic hyperplasia also known as BPH.

We have built the infrastructure to allow broad market access to F. C. Two across the U S. As a result F. C. Two is now available through multiple sales channels. We have partnered with fast growing highly reputable telemedicine platform companies to bring our F. C. Two product to patients in a cost effective and highly convenient manner our strategy.

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.

To continue to drive FC to sales is as follows one.

One, we will seek additional telemedicine internet pharmacy service partners.

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.

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.

This telemedicine platform is now up and running and is expected to be a new source of revenue.

Website address is F C. Two condoms dotcom.

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 EFAXIS.

Three we've increased U S public sector sales by our new agreements with distribution partnerships with global protection, that's where I was faxes.

We also have in Tassie and F. D. A approved new treatment for benign prostatic hyperplasia. The most common side effects of currently prescribed at BPH medicines, a sexual adverse events, including Internet and Cathy has been shown to be faster and more effective for the treatment of benign prostatic hyperplasia than finasteride alone.

We also have Entafi, an FDA approved new treatment for benign prostatic hyperplasia, the most, common side effects of currently prescribed FBPH medicines are sexual adverse events, including impotence. Entafi has been shown to be faster and more effective for the treatment of benign prostatic, hyperplasia than finasteride alone without causing impotence.

Without causing incidence I'm happy to report that we have officially launched in taxi and the product is available for pharmacies to dispense we have partner with good Rx a U S based digital resource for health care to eat they're almost 20 million monthly visitors, which includes both consumers and health care providers.

I'm happy to report that we have officially launched Entafi 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 Entafi.

To build awareness about in tap fee. 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 CEO to discuss the financial highlights Michele.

There are over 45 million prescriptions filled annually for drugs that 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 Michelle Greco, CFO and CAO, to discuss the financial, highlights.

Michelle?

Thank you Dr. Steiner is Dr. Steiner indicated we have a lot of activity at here that's.

Thank you, Dr. Steiner.

They will not wait for FDA's decision to affect their own review decision, right?

As Dr. Steiner indicated, we have a lot of activity at VIRU.

Yeah.

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.

So if you look at the emergency use authorizations for molnupiravir, it turned out that MHRA approved, had the emergency use authorization done before U.S.

To start our highlights with the third quarter results for the three months ended June 30 of 2022.

So they are very independent.

Overall, net revenues were $9 $6 million compared to $17 $7 million in the prior year third quarter the.

And so just to be very clear, MHRA's independent, EMA independent, FDA's independent.

The prescription business net revenues decreased from $13 $5 million in the prior year third quarter to $6 $7 million.

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.

Global public sector, net revenues were $2 $9 million compared to $4 $2 million in the prior year's 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 saw $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 US FC2 prescription business.

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.

<unk> gross profit and gross margin.

And primarily by the reduction in sales in our U S. F C. Two 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. And 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 four Phase III clinical trials and two Phase II clinical trials ongoing while in the prior period we had two Phase III clinical trials and two Phase II clinical trials ongoing.

Operating expenses for the quarter increased to $28 $9 million compared to the prior year quarter at $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 and 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 cost is due to the increased number of clinical trials. This quarter. We had four phase III clinical trials in two phase two clinical trials ongoing while in the prior period, we had two phase III clinical trials in two phase two clinical trials ongoing.

The increase in selling general and administrative expenses is primarily due to the increase in head count related to the preparations for the commercial launch of Entadfi and Subizabulan for COVID-19 resulting in increased compensation, increased stock compensation and increased sales and marketing expenses.

The increase in selling general and administrative expenses is primarily due to the increase in head count related to the preparations for the commercial launch of <unk> taxi and to visit the island 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.

Operating loss for the quarter was $21.8 million compared to $2 $9 million in the prior year quarter.

Non operating expenses were $234000 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.

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% to 25%.

For the quarter, we recorded a tax expense of $138000 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 rate.

It's from 19% to 25% the bottom line results for the third quarter of fiscal 2022, with a net loss of $22 $2 million or 28 cents per diluted common share compared to a net loss of $2 $7 million or three cents per diluted common share in the prior year third quarter.

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.

Turning to the results for the nine months ended June 30 of 2022.

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 with $29 $9 million compared to $32 $9 million in the prior year period.

The net revenues for the global public health sector business was $6.9 million compared, to $11.8 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.

Reduction of the prescription net revenues is due to the business challenges experienced by a 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.

Decrease in sales in the global public sector. During the period is due primarily to $9 7 million units sold in 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 $31 million or <unk>, 82% of net revenues compared to $35 $6 million or 78% of net revenues in the prior year period.

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.

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, a $39 $2 million.

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.

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 cost 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.

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 pre-boost of $18.4, million in the prior year period.

The change of $53 $4 million is primarily due to the gain on sale of pre boost 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.

The increase in research and development costs during the current year period and the reduction, in net revenues in gross profit which occurred during the third quarter.

Non operating expenses were $4 million compared to $5 $9 million in the prior year period, primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing.

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 months period, we recorded a tax expense of $225000 compared to a tax benefit of $2 $8 million in the prior year period.

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 carry-forwards 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 carry-forwards of $63.5 million which do not expire.

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.

K subsidiary has net operating loss carryforwards of $63 $5 million, which do not expire.

The bottom line result for the first nine months of fiscal 2022 with a net loss of $42 8 million or 53 cents per diluted common share compared to net income in the prior year period, which included the gain on sales people instead of $11 $7 million or 14th Protos dilutive common share turn.

The bottom line result for the first nine months of fiscal 2022 was a net loss of $42.8, million or 53 cents per diluted common share compared to net income in the prior year period which included a gain on sale of pre-boost of $11.7 million or 14 cents 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.

Turning to our balance sheet.

As of June 32022, our cash balance was $106 million and our accounts receivable were $8 $3 million. Our net working capital was $106 million on June 30 of 2022 compared to $136 million at September 30th 2021 during the nine months.

Our net working capital was $100.6 million on June 30, 2022 compared to $136 million, at September 30, 2021. During the nine 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.

Ended June 30th 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 Subizibulin for COVID-19, the continued revenue from sales, in the USFC2 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.

The expected future revenues from the visit beyond for COVID-19 that continued revenue from sales in the U S. F C. Two prescription business and global public sector business, coupled with the expected future revenue from the launch of <unk> taxi 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 E. L. D S 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 three actively enrolling phase III clinical studies and we have significant revenue generated more base sexual health business.

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 three actively enrolling phase three clinical studies, and we have significant revenue generated from our base sexual health business and have authorized we expect to have substantial future revenue, Subizibulin 9 mg for hospitalized COVID-19 patients at risk for ARDS.

And if authorized we expect to have substantial future revenue <unk> nine milligrams for hospitalized COVID-19 patients at risk for a R. T S being.

Being opportunistic and successful in developing so busy bulent to COVID-19 has led to the most eventful and transformative period in <unk> history.

Being opportunistic and successful in developing Subizibulin to COVID-19 has led to the most, eventful and transformative period in Veru's history.

And if any one of those three organizations authorize subitibulin, then about 80% of the countries in the world will take that as a trigger to authorize it in their country.

We are preparing for the U S and global commercial launch of <unk> nine milligrams for the treatment of hospitalized mild to severe COVID-19 patients with high risk. They are D. S. 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.

We are preparing for the US and global commercial launch of Subizibulin 9 mg for the treatment, of hospitalized mild to severe COVID-19 patients with high risk for ARDS.

As you can see from our balance sheet, we have the resources for these launch activities, in the US and global if granted emergency use authorization.

Again, we believe this will be an opportunity for significant near-term revenue for Veru.

Got it.

Be an opportunity for significant near term revenue to zero.

With that I'll now open the floor.

With that, I'll now open the floor to call to questions.

The call to questions.

Operator?

Operator.

Thank you.

Thank you ladies and gentlemen at this time, we will begin the question and answer session.

Ladies and gentlemen, at this time we'll begin the question and answer session.

Thank you.

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I'd like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.

Our first question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.

Our first question comes from Brandon Foulkes from Cantor Fitzgerald.

Thank you.

Please go ahead.

I appreciate you joining us on today's call.

Hi.

I look forward to updating you all on our progress in our next investor's call.

Thank you.

Alright, Thanks for taking my questions and congratulations on all the progress and just from me I guess first up a multipart question can you just elaborate on the orders of these clinical trials and how typical with Nissan the EUA approval.

Thanks for taking my questions and congratulations on all the progress.

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The conference call is now concluded.

Just from me, I guess first off, a multi-part question.

Can you just elaborate on the orders 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?

The indication at this stage that the two upcoming ex U S site audits.

Would be the law. So do you believe the agency may look to continue to order additional facility.

And then within that where these facilities picked randomly and granted the FDA picked it but just any commentary or are there any data outline that may have driven the selection of these audits.

And then within that, were these facilities picked randomly?

Granted, the FDA picked it, but just any commentary or are there any data outliers that may have, driven the selection of these audits?

Okay.

Okay and make sure I understand the first question Susan can you say it again, ladies as clinical trials that you're talking about the new additional ones.

And make sure I understand the first question.

Can you say it again?

It believes it's clinical trials.

Are you talking about the new additional ones?

No, the clinical sites.

The clinical sites.

Oh, clinical sites.

So the clinical sites.

No, no, no.

So your first question.

Yeah. So your first question. So it's always best clinical sides. Okay. My my my bad as they say so no I don't so first of all our expectation is that.

So it's always about clinical sites.

Okay.

Medical sites.

Okay.

My bad, as they say.

So, no, I don't.

So first of all, our expectation is that the FDA, after they audit these two sites, there's, no indication that they're going to be auditing additional sites.

Yeah that the F D. A after they would be after they oddities two sides, there's no indication that they're gonna be auditing additional site.

They've been pretty clear.

They've been pretty clear.

As it relates to why they pick these sites are there.

As it relates to why they picked these sites, there's no indication that any particular, site has an issue.

There's no there's no indication of any particular site has an issue.

This was done on the G. C. P. We have an excellent CRO called world clinical trials and the impression that we get is that the FDA is checking their boxes.

This was done under GCP.

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 very important review.

As they go through this very important we review and so I see this is routine and I had to have with me Dr. Gary Barnett Who's our Chief Scientific officer, and you want to add comments to that.

And so I see this as routine.

I do have with me Dr. Gary Barnett, who's our Chief Scientific Officer, and if you want, to add a comment.

This is generally a standard practice under NDA review where they go into these clinical sites and they pick the clinical sites.

Yes.

This is generally a standard practice under NDA review, where they go into these clinical study sites and they picked preclinical sites.

<unk> teams selected clinical sites for things like the number of patients that they put into the study and that kind of thing.

So the two in the U S have been completed without any findings adverse findings to outside it does take a little longer for.

For the FDA to owe to us.

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.

Schedule.

Outside the United States for audit because of all the political things that have to go along with that but.

But we expect these sites too.

To do very well in those orders.

As Mitch mentioned, we do not believe that there'll be any additional.

So clinical sites.

After these.

So the two in the U.S. have been completed without any findings, adverse findings.

Great I appreciate the additional color and then maybe just.

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.

Should you receive an EUA.

But we expect these sites to do very well in those audits.

How should we think about how quickly you can get the product into the hands of the hospitals.

Yeah, Great question. So we have done a lot of work thanks to the internal team and you know and we quickly assembled a team, but it's a robust team and for things that we can't do internally I E.

But as Mitch mentions, we do not believe that there will be any additional audits of clinical sites after these.

Great, I appreciate the additional color.

You know bring that we've brought in sort of the the chiefs are 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 and wholesaler.

And and because that's that's really that's 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 very efficiently done are the ones that we picked also.

Big player with government contracts as well and so it's a pretty robust so with that said if we get you know get the EUA.

And then maybe just should you receive an, EUA?

We get the EUA and and and get the word go we believe it'll be somewhere between 90 days to 14 days that we will have the drug available with dispense in hospitals.

In the U S.

Thanks, Mike that's very helpful.

Good luck and congrats playful.

Great. Thank you.

The next question comes from Leland yourself from Oppenheimer. Please go ahead.

How should we think about how quickly you can get the product into the hands of the hospitals?

Hi, good morning, Thanks for taking.

My questions must be very busy days Peru.

Yeah, great question.

Two questions for me first.

Again with respect to FDA activities heading into the <unk>.

So we have done a lot of work thanks to the internal team.

And we've, quickly assembled a team, but it's a robust team.

A decision you had 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.

You already have one that's been inspected and I've got a couple more.

And 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.

Sure. So to answer your question. We have is essentially there's really three buckets. So we have an API, which is manufactured by old laundry circa and they have a facility in Italy and in the U S. O Languish circuit has clearly been audited by the F. D. A numerous occasion.

And this is the same API group that made that makes a moment peer of ear for Merck.

So usually the F D. A doesn't go back to a site that's been recently inspected and they're happy and so this site.

We do not believe will be a further inspected by F D. A.

Facility is core Rx, which is the group that manages that put together the drug product and puts it into capsules that group was out of Clearwater, Kal Clearwater, Florida, and they have a commercial products, including our product in tap fee and so we know they have been recently audited and.

Inspected I should say and and they did great and so we're not expecting a you know another audit another another inspection because they've just been recently inspected so we're not expecting F D. A to go to that group.

We have a packaging manufacturing facility called out FEMA.

And in the U S and they have not been inspected by the FDA recently and so the F. D. A chose that site to do a preapproval inspection as I mentioned in my comments that went well.

So from a manufacturing standpoint, I think we're set.

Okay, Great and then.

Options for the most severe.

Patients in the hospital at high risk.

COVID-19 remains limited and given the compelling phase III data.

Wanted to ask as you have discussions with with both private and public.

Thank you ladies out there.

Would be interested in getting hold of Davita Julien.

Comment on any interest in securing certain amounts.

Thanks.

Could we see any.

The purchase agreement for another such agreement to secure supply as the visit fee only perhaps materialize.

Or the EUA.

Yeah.

Right. So the answer to your question just so we're clear.

In the U S Hospital based COVID-19 products.

Our are handled differently than non hospital based COVID-19 products or vaccines.

So vaccines and drugs like packs a logo among the peer of here.

Because it's part D D as in dog a Medicare.

They're handled by government purchases that were then distributed by government Okay.

And because that's really the way hospitals work, that's where you need to drop ship your product.

In the hospital setting it's much much more efficient to work through the hospital system. So when you look at all of the hospital based EUA drugs, they're managed by a DRG DRG payment to the what they call in and see tap which is a.

Basically a new technology that Covid technology added payments through Medicare and and they have all other kinds of sweeteners to help the hospitals deal with the complicated DRG.

Complicated patients COVID-19 patients that are that the obviously the DRG alone is not going to cover it so they have additional sweeteners.

It seems to work I mean, if you look at Red Desert beer, which is under the system last year. They brought in almost $465 billion in the system.

And so so so so I can see why you know why mess with the distribution system and by the way. That's part a is an alphabet so that means.

The hospitals and this is an important point that means that the hospitals have to seek reimbursement not the company. So the company provides product to the wholesaler.

And that distributor is the one that gets it to all the hospitals. And it's very routinely done and very efficiently done.

We do that we booked sale the wholesale with sells it into the hospital the hospital gets their reimbursement for the DRG.

Not for the drug itself and and so you know once it once it leaves our hands and we can book it. So it's very interesting system.

The one that we picked also is a big player with government contracts as well.

Ex U S. However.

There there there is I mean ex U S. There is definitely an advance purchase agreement system, where governments, whether it's hospital base or whether it's you know.

Out of the hospital non hospital base.

They buy.

And so it's pretty, robust.

And so we had 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.

So with that said, when we get the EUA and get the word go, we believe it will be somewhere between nine days to 14 days that we will have the drug available for dispense in hospitals in the U.S.

Thanks, Mitch.

To.

To understand the drug to understand.

That's very helpful.

And best of luck and congrats to you all.

How much they want to purchase.

So we're working through that with like I said across the world.

What's also interesting about that is starting to give us an indication of a little bit about demand. So that we can make sure that we've made enough for the world.

You know, we will have to allocate as we as we get into the next year, we will catch up and hum, but but one of the things that sort of an interesting wrinkle is that.

Europe , which which which has expanded our article 18 was a little bit of a surprise to us because we didn't really know what the Hell article 18 months.

And article 18 was it turns out to be a very very important article.

Because in January of 2022, the EMEA recognize they need is something similar to an EUA.

And consequently are they they allow the emergency task force and 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 the room.

And and and and 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 going to launch commercially in Europe , you typically pick certain countries the launch and that kind of stuff. So this is really different and so we're you know so that was that so that has been.

Triggered and we're in active discussions with the emergency task force in the U same thing with MH or a and then we're also been in discussions with other groups that have set up in the expedited a provisional type.

Processes. So it is 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 in the fall and the winter coming up or for example in Korea, which is public information Korea has said publicly and their newspapers there.

We're reviewing <unk> and and Korea is a 10th largest economy Korea is approaching the small country of 50 million people, who are starting to see about 100 110000, new cases of.

Of COVID-19.

A day their.

Hospitalization rates are going up and there are death rates are going up in there and they're very worried and and when we speak to them, they're always wearing masks. So they have they kept their masks on and.

So so so we are expecting a I think it's fair to say, we are expecting a P. As in multiple locations around the world.

Territories and countries. However, I think it's clear to say that many of these a P. A's are gonna be triggered by either the EUA authorization are in U S E.

EMA authorization emergency use authorization of MH or a authorization so they're looking for cover in one of those three Terry one of those three agent.

Agencies. So I think that's clear now where we have one offs with certain agencies that do their own work I'm just getting the impression now having gone to going through this that they really look to the F. D. A and they look to the EMA and they look to MH or aid it used to be part of the EMA.

For for guidance, but any one of those three it will open up the 80% of the countries that are out there that are interested in getting the drug.

Great.

What does the phase two.

Having been up and.

Running for some time.

The data from that trial.

Around this time, just wondering if you could just share any thoughts or expectations.

So when we made.

Data from that study.

Thanks.

Yeah. So very 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 and you have to it turns out for Gnrh antagonist that you gave US a depot you have to have a certain level to cause to castration and you have to have another blood level.

That that maintains that castration and they're different and we're asking a single injection to do both.

And I'm happy to report, we can do that so.

So now we're just optimizing the dose and I feel very confident that this is going to be a very interesting product for prostate cancer because.

We know the agonists have their issues and so we can have an antagonist that can go beyond one month and we have patients clearly beyond one month approaching we have somebody approached three months. So that's why I said in my comments is promising but we're optimizing so that this way when we go to the 100 patients in the phase III every one of those patients will.

Castrate immediately and maintained their castration for three months, so sit tight I'll be able to provide more clarity I hope over the next few weeks.

Okay. Thanks for taking the questions.

Thank you.

The next question comes from Chris Howerton from Jefferies. Please go ahead.

Great.

Great. Thanks, so much for taking the questions.

I guess two for me one would be with respect to the kind of distribution and government assistance with respect to COVID-19 in the United States.

Thank you.

How should we be thinking about the status of the public health emergency and.

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 in those reimbursement parameters that you discussed earlier, Mitch and then the second question. The second question that I had 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. So just wondering if you have any updates in terms of prioritization in terms of cash deployment given that observation.

Yes.

The next question comes from Leland Gersho from Oppenheimer.

Alright, So let me ask answer the first question.

So the first question is basically that's great you've got these sweeteners in in the hospital setting and it worked for Graham Desert here in our other hospital based products.

Please go ahead.

Hi.

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 and see tap which is a.

Good morning, Mitch.

Thanks for taking my questions.

Must be very busy days here at Baruch.

You know a a COVID-19.

Added payment that is there's also provides more resources so there.

A few questions from me.

Hospitals can you know get close to 75% plus covered.

And and that's wonderful I'm glad we have that but what the question and it works and the question is what happens when the emergency goes away.

So our so first of all the first fact is that are these.

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.

These programs will stay in place until the end of that calendar year. So we're going into the fall and winter this fall into winter.

And 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 use then pushed into next year and then 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 rates pretty closely what's been your one year or two.

So it feels like it'll continue then that would mean if it goes into January of next year, then they will be required to pay until the end of January of 2023.

They do that is there are other programs that you can transitioned into <unk> instead of N. C. Tab. This is called <unk> and tab and tap has been in place against new technology added payment and and and and tap will only work. If you have a full approval so what we'll be doing.

For a full approval through an NDA. So obviously, we'd be doing after the EUA.

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.

Have a meeting with FDA for a pre NDA meeting and the <unk>.

And I've got a couple more.

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 our emergency use authorization to a full approval and the full approval will then allow us to trigger the <unk> tap and some of those payments. So there is a strategy.

To allow us to continue to see them.

Thus reimbursement.

As it relates to the.

Capital strategy.

Yes, we saw a slowdown in FSC to remind you that's why it's important for us not to be reliant on our customers and that's why we created our own direct to consumer portal.

I think it was a timely move on our part because it takes time and it's in and it's working it feels good because we are seeing revenue coming in from that portal and and it allows us to be in control of our own destiny as it relates to getting capital and so in addition to a full expectation.

Based on our communications with our customers that the you know the whole telemedicine and group.

Across the board got hit.

As people, who have transitioned from staying at home to going back out and go back home and probably at some point, but it's being it's turning around.

And and we're expecting fourth quarter to be better in next year to be even better.

With that said you know anything can happen, but that's the signals that we're seeing and in our own portal allows us to have control and tad fees completely new revenue.

And as I've said in my comments, who we are and you know we are in discussions with a large telemedicine group.

That can help us with that and plus you know, we're moving very very actively with good Rx and and in market access and this is an easy one to sell if you talk to urologists about entad fee, which is a combination of the retinal dysfunction medicine, and a medicine that shrinks the prostate.

And but it shrinks prostate faster and more effectively than finasteride alone that they get it and they are in and I think I think 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 so.

We know the leverage the pool.

And so we would do the same thing so as the as well.

We're not waiting for revenue to catch up we're going to we're managing our business. So that we can.

So that we can be.

Efficient and clinical trial recruitment and getting you know getting to commercialization.

But but again as you mentioned that you have to prioritize so at this point now we're focused highly on the nobu sorry, I'm in a in a second line setting in a third line setting and.

We have the veracity study going into phase III recruiting and Mir 100 is one of those so there's just such a established market that once we can get there that could be a nice cash cow.

In the meantime.

Uh huh.

If the emergency use authorization is granted and we get resources when we drop.

Drop ship product to the distributor and we're not worrying about reimbursement because that's not our that's not what we do it's not like part D, where you wait for the prescription to be filled in this situation. Once it goes into the wholesaler. We can get the money then there is a real opportunity to see significant revenue.

Within two weeks or so from the time, we get to EUA, which means that we will have the capital to continue.

The new phase III studies for COVID-19.

And I take it you know to maintain our business and our end to end it become profitable. So so so you know this.

Where.

We still we still have the fundamental company in place we have a core oncology business is doing great. We have the resources to match.

The spend and even with the extra spend as you heard him Michele getting ready with our with the COVID-19 infectious disease franchise, our we've done very well to have those resources ready to go and we didn't have to do a raise in Duluth. So I think we've I think we've done a good job managing our finances.

<unk>.

I would agree. Thank you so much Mitch for the taking the questions and congratulations.

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 each N from H C. Wainwright. Please go ahead.

Thank you for taking my question just to clarify.

<unk> U K immature already started at <unk>.

For so.

So these are booming.

To clarify when we do first the way the process works.

As you have to meet with their COVID-19 task force. So we have to submit the materials to begin that process and so when we met with them as we said in the press release. They were so excited about the medicine.

That's the entire task force basically said you know you submit because there's a process and the NHRA you submit.

And we're gonna supported for expedited review and they're the only ones that can do that and however, you have to submit and so and.

And so 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 and so we're as we speak now the applications being prepared for submission and and and then they can start the clock once they start the clock and against the clock.

It is unclear at this point, but once we have more clarity I'll be able to share that with you but that that's that's in place.

So the U K and make sure he's review process and.

Review process are completely independent from Fda's EUA review process correct. They will not wait for Fda's decision to effect.

Yeah.

Right.

Yeah. So if you look at the if you look at the emergency use authorizations for among their peers here. It turned out that the MH or a approved have the emergency use authorization or you know.

Done before U S. So they are very independent and so just to be very clear.

MH or as independents.

M a independent Fta's independent and if any one of those three organizations authorize submitted fueling and about 80% of the countries in the world will take that as as a trigger to to authorize it in their country.

Got it thank you.

Yeah.

Thanks.

Ladies and gentlemen, I'm, sorry, ladies and gentlemen. This concludes our question and answer session I would like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.

Sure.

So, to answer your question, we have essentially, it's really three buckets.

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.

So, we have the API, which is manufactured by Olan Reserca, and they have a facility in Italy and in the U.S. Olan Reserca has clearly been audited by the FDA on numerous occasions.

And this is the same API group that makes Molnupiravir for Merck.

So usually the FDA doesn't go back to a site that's been recently inspected, they're happy.

And so 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 in Tadphy. And so we know they've been recently audited and inspected, I should say, and they did great.

And so we're not expecting another audit, another inspection, because they've just been recently inspected.

So we're not expecting FDA to go to that group.

Thank you.

We have a packaging manufacturing facility called Alfina in the U.S., and they have not been inspected by the FDA recently. And so the FDA chose that site to do a pre-approval inspection.

Could we see any ATAs, Advanced Purchase Agreements, or any other such agreements to secure supplies to Cifidibulin, perhaps materializing for the EUA?

And as I mentioned in my comments, that went well.

Yeah.

And so from a manufacturing standpoint, I think we're set.

So the answer to the question, just so we're clear, in the U.S., hospital-based COVID-19 products are handled differently than non-hospital-based COVID-19 products or vaccines.

The digital replay of the conference call will be available beginning approximately noon eastern time today August 11th Baidu.

Okay.

So vaccines and drugs like Paxilovir and Monopiravir, because it's Part D, D as in dog, Medicare, they're handled by government purchases that are then distributed by government.

Great.

Okay.

And then, 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 three data, I wanted to ask, you know, as you have discussions with both private and public entities out there that would be interested in getting a hold of Cifidibulin, can you comment on any interest in securing certain amounts up front?

In the hospital setting, it's much, much more efficient to work through the hospital system.

So when you look at all of the hospital-based EUA drugs, they're managed by a DRG, a DRG payment, what they call an NCTAP, which is basically a new technology, COVID technology, added payment through Medicare.

And they have all other kinds of sweeteners to help hospitals deal with the complicated DRGs, complicated patients, COVID-19 patients, that obviously the DRG alone is not going to cover it. So they have additional sweeteners.

It seems to work.

I mean, if you look at Remdesivir, which was under the system last year, they brought in almost $4.65 billion in the system.

And so I could see why, you know, why mess with the distribution system.

By dialing one 870 7344.

By the way, that's part A as an alphabet.

So that means the hospitals, and this is an important point, that means that the hospitals have to seek reimbursement, not the company.

So 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. And so, you know, once it leaves our hands, then we can book it. So it's a very interesting system.

Ex-U.S., however, there is, I mean, in Ex-U.S., there is definitely an advanced 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.

75 to nine in the U S and one for 123170088 internationally, you'll be prompted to enter the replay access code, which will be 190 to 173. Please record your name and company when joining the.

And so, 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 want to purchase.

And so, you know, we're working through that, like 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.

You know, we will have to allocate.

As we get into the next year, we will catch up.

But 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.

And Article 18 turns out to be a very, very important article, because in January of 2022, the EMA recognized they needed something similar to an EUA.

And 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 VIRU.

And 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 going to launch commercially in Europe.

All right, so let me answer the first question.

You typically pick certain countries to launch and that kind of stuff.

So this is really different.

And so that has been triggered, and we're in active discussions with the emergency task force in the EU.

Same thing with MHRA.

And then we've also been in discussions with other groups, that have set up either expedited or provisional-type processes.

So it does feel different.

I mean, 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, Korea has said publicly in their newspapers they're reviewing sibizibulin.

And Korea is the 10th largest economy.

Conference call has now concluded thank you for attending today's discussion.

Korea is approaching the small country of 50 million people.

We're starting to see about 100,000, 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.

And when we speak to them, they're always wearing masks, so they kept their masks on.

And so 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 going to be triggered by either the EUA authorization in the U.S., EMA authorization, emergency use authorization, and MHRA authorization.

[music].

So they're looking for cover in one of those three agencies.

So I think that's clear.

Will we have one-offs with certain agencies that do their own work?

I'm just getting the impression now, having gone 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.

But 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 two having been up and running for some time, Bob, you may see data from that trial, around this time.

Just wondering, Mitch, if you could just share any thoughts or expectations as to when we may see the data from that study of VIR100.

Thanks.

So VIR100 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, it turns out for GnRH antagonists that you give as a depot, you have to have a certain level to cause the castration, and you have to have another blood level that maintains that castration. And they're different, and we're asking a single injection to do both.

And I'm happy to report we can do that.

So now we're just optimizing the dose, and I feel very confident that this is going to be a very interesting product for prostate cancer, because we know the agonists have their issues, and so we can have an antagonist that can go beyond one month.

And we have patients clearly beyond one month, and we have some that approach three months.

So that's why I said that my comments is 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.

So sit tight.

I'll be able to provide more clarity, I hope, over the next few weeks.

Okay.

Thanks for taking the questions.

Thank you.

The next question comes from Chris Howerton from Jeffries.

Please go ahead.

Great.

Thanks so much for taking the questions.

I guess two for 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 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?

And then 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.

So just wondering if you have any updates in terms of prioritization in terms of cash deployment, given that observation?

Yes.

So the first question is, basically, that's great, you've got these sweeteners in, 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 NC TAP, which is a, you know, a COVID-added payment that is, that is 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 what the question, and it works, and the, question is what happens when the emergency goes away?

So first of all, the first fact is that these programs will stay in place until the end, of that calendar year. So if we're going into the fall and the winter, 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 gets then pushed into the next year, and 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, so it's been year one, year two, so 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 NC TAP, this is called NTAP.

So NTAP has been in place, and again, it's a new technology-added payment, and NTAP will, only work if you have a full approval.

So we'll be doing full approval through an NDA.

So 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, and the full approval will then allow us to trigger the NTAP and some of those payments.

So 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.

Okay.

[music].