Q2 2022 Veru Inc Earnings Call

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Operator: Good morning, ladies and gentlemen, and welcome to Veru Incorporated's investor conference call. All participants will be in a listen-only mode.

Good morning, ladies and gentlemen, and welcome to Beirut incorporated Investor Conference call.

All participants will be in a listen only mode.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Incorporated's Executive Director of Investor Relations and Corporate Communications. Please go ahead.

Should you need assistance. Please signal conference specialist by pressing the star key followed by zero.

After this mornings discussion there will be an opportunity to ask questions.

Please note that this event is being recorded.

I would now like to turn the conference over to Mr. Sam Fisch Barrow incorporated Executive Director Investor Relations and corporate Communications. Please go ahead.

Samuel Fisch: Good morning. The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statement. Risks that may cause actual results or development to differ materially are contained in our 10-Q and our 10-K SEC filings, as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru, Inc.'s Chairman, CEO, and President. Good morning.

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

Forward looking statements may include but are not necessarily limited to statements of the company's plans objectives expectations or intentions regarding its business operations finances, and development and product portfolio.

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

Risks that may cause actual results or developments to differ materially are contained in our 10-Q, and our 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 <unk>, Inc, Chairman CEO and president.

Mitchell Steiner: With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer; Michele Greco, CFO and CAO; Michael Purvis, EVP, General Counsel, Corporate Strategy; and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast and prostate cancer. The company has a commercial sexual health division called UREV, which includes two FDA-approved products in TADFI, a new treatment for benign prostatic hyperplasia, and the FC2 female condom, an internal condom, for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.

With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michele Greco the CFO and CEO .

Michael Purvis, EVP General counsel, and corporate strategy, and Sam Fisch Executive director of Investor Relations and corporate communications. Thank you for joining our call.

Mitchell Steiner: The revenue from the sexual health division is being used to largely fund the clinical development of our late-stage drug candidate assets, which aim to address multi-billion dollar premium market opportunities. This morning, we will provide an update on the COVID-19 subisibulin clinical program and franchise, the clinical development of our oncology drug pipeline, and the commercialization of our products. We will also provide financial highlights for our second quarter of fiscal year 2022. While there have been recent emergency use authorizations for antiviral drugs, Molnupiravir from Merck and Paxilovid from Pfizer, for the treatment of unhospitalized patients with COVID-19 with less than five days of symptoms who are at relatively lower risk of dying, sibizibulin, in contrast, is being developed for hospitalized, moderate to severe CO Tibizibulin disrupts intracellular transport of coronaviruses along microtubules.

<unk> is a biopharmaceutical company focused on developing novel medicines for COVID-19, and other viral and E. R. D escalating diseases and for the management of breast and prostate cancers. The company has a commercial sexual health Division called you Rev, which includes two FDA approved products in tassie and new treatments are benign prostatic hyperplasia.

Please yes, and the <unk> female condom internal condom for the dual protection against unplanned pregnancy, and the transmission of sexually transmitted infections. The revenue from the sexual health Division is being used to largely fund the clinical development of our late stage drug candidate assets, which aimed to address multibillion dollar premium market opportunity.

This morning, we will provide an update on the COVID-19 should visit Bulent clinical program and franchise the clinical development of our oncology drug pipeline.

And the commercialization of our products. We will also provide financial highlights of our second quarter fiscal year 2022.

While there have been recent emergency use authorizations for antiviral drugs, while new peer of ear from Barrick impacts a little bit from Pfizer for the treatment of on hospital lives patients with COVID-19 with less than five days of symptoms were relatively lower risk of dying to visit Bulent. In contrast is being developed for hospitalized.

Moderate to severe COVID-19 patients, who had high risk of acute respiratory distress syndrome and that patients for whom there is currently no clearly effective treatment and the population, which only peer review the antiviral agent for Merck did not demonstrate efficacy.

Bulent disrupts intracellular transport of Corona viruses, along the microtubules. This is a highly conserved biologic process. That's required by all variance of COVID-19, including <unk> to cause infection.

Mitchell Steiner: This is a highly conserved biological process that's required by all variants of COVID-19, including Omicron, to cause infection. We conducted a phase 3 COVID-19 clinical trial, which was a double-blind, multi-center, multinational randomized 2-to-1 placebo-controlled study evaluating daily oral 9mg dose of sibizibulin for up to 21 days versus placebo in approximately 210 hospitalized moderate-to- Both the placebo and subizabulin-treated groups were allowed to receive standard of care, which could include dexamethasone, remdesivir, anti-IL-6 receptor antibodies, and JAK inhibitors.

Mitchell Steiner: Moderate to severe COVID-19 symptoms in this study mean patients that were hospitalized and required supplemental oxygen, forced oxygen, or mechanical ventilation. Furthermore, one of the inclusion criteria is that patients must have a peripheral capillary oxygen saturation of less than or equal to 94% on room air.

We conducted a 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 dose of <unk> for up to 21 days versus placebo in approximately 210 hospitalized moderate to severe COVID-19.

Patients, who had high risk with <unk> than that.

Both the placebo and too busy bulent treated groups were allowed to receive standard of care, which could include dexamethasone when desert here anti IL six receptor antibodies and JAK inhibitors moderate to severe COVID-19 symptoms. In this study means patients that were hospitalized and required supplemental oxygen force.

Oxygen or mechanical ventilation.

Furthermore, one of the inclusion criteria is that patients must have a peripheral capillary oxygen saturation of less than or equal to 94% on room Air. This is a very sick patient population at high risk <unk> and death.

Mitchell Steiner: This is a very sick patient population and is at high risk for ARDS and death. The pre-specified primary efficacy endpoint is the proportion of patients who die during the study up to day six, not up to day 29 like other studies reported in the literature. Our day 60 endpoint allowed us to capture a more accurate number of deaths caused by COVID-19 infection. Secondary endpoints included the proportion of patients without respiratory failure days in the ICU.

The prescribed the pre specified primary efficacy endpoint is the proportion of patients who die on study up to day 60, not up to day 29.

Other studies reported in literature or day, 60 endpoint allowed us to capture a more accurate number of deaths caused by COVID-19 infection secondary endpoints included the proportionate patients without respiratory failure days in the ICU.

Mitchell Steiner: WHO Ordinal Scale for Clinical Improvement Change from Baseline, Days in Mechanical Ventilation, Days in the Hospital, and Viral Load. The study was conducted in the United States, Brazil, Argentina, Mexico, Colombia, and Bulgaria, and COVID-19 infections in the study included the Delta and Omicron variants.

W. H O ordinal scale for clinical improvement change from baseline days of mechanical ventilation days in the hospital environment load. The study was conducted in the United States, Brazil, Argentina, Mexico, Colombia, and Bulgaria, and COVID-19 infections. In this study included the Delta and Omar Khan variance.

Mitchell Steiner: In January of 2022, the FDA granted FASTRAC designation to the Phase 3 COVID-19 Registration Program. FASTRAC designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy when none exists or providing a therapy which may be potentially better than an available therapy. Thus, having fast track is a distinction that underscores the urgent need for new, novel, and effective therapies to be used alongside vaccines to combat this COVID-19 pandemic.

In January of 2022, the FDA granted fast track designation to the phase III COVID-19 registration program.

Fast track designation aims to expedite the development and review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to fill unmet medical need filling an unmet medical need is defined as providing a therapy would not exist or providing a therapy, which may be potentially better than an available therapy. That's having fast track is a.

This distinction that underscores the urgent need for new novel and effective therapies to be used alongside with vaccines to combat. This COVID-19 pandemic.

Mitchell Steiner: April 8, 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 data, the Independent Data Safety Monitoring Committee unanimously recommended that the Phase III study be halted early due to overwhelming efficacy. They also remarked that no safety concerns were identified.

On April eight 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 data the independent data safety monitoring committee unanimously recommended that the phase III study would be halted.

Early due to overwhelming efficacy. They also remarked that no safety concerns were identified.

Mitchell Steiner: The pre-specified primary endpoint was deafness at or before day six. Subisibulin treatment resulted in a clinically and statistically meaningful 55.2% relative reduction in death, p-value equals 0.0043, in the intent-to-treat population. The placebo group, N = 52, had a 45% mortality rate compared to the 20% mortality rate in the subisobulin-treated group, N = 98, at day 29. The death rate in the placebo group in our study was 35%, which is the same death rate as reported in the Lancet publication in May 2020-2021 for the placebo group of a similar hospitalized patient group consisting of 2,094 patients for the Tocilizumab Furthermore, one could expect the death rate in the placebo group on Day 60 to be higher than the death rate on Day 29.

The pre specified primary endpoint was death.

At or before day 60, <unk> treatment resulted in a clinically and statistically meaningful 55, 2% relative reduction in death P value equals 0.0043 in the intent to treat population.

Placebo group and equals 52 had a 45% mortality rate compared to the 20% mortality rate.

A busy bulent treated group and equals 98.

At day 29, the death rate in the placebo group in our study was 35% which is the same death rate as reported in Atlanta publication in May 2000, 22021 for the placebo group of similar hospitalized patient group.

Consisting of 2094 patients for the Tokyo is am I Mab recovery study. Furthermore, one could expect a death rate in the placebo group a day 60 to be higher than the 29 death rate.

Mitchell Steiner: The placebo group at day 60 death rate of 45% in our study underscores how sick these patients really were. Moreover, patients in the phase 3 COVID-19 study were allowed to receive standard of care which was balanced between the subisibulin and placebo groups, with approximately 80% receiving dexamethasone and about 30% receiving remdesivir. Thus, high death rates in the placebo group demonstrate the inadequacy of the current standard of care. We plan to publish the secondary efficacy endpoints in a peer-reviewed medical journal as soon as possible. Subvisivulin treatment was well tolerated in this patient population, with no clinically relevant safety observations in the subvisivulin-treated group compared to placebo.

The placebo placebo group at <unk>.

<unk> 60 death rate of 45% and our study underscores how sick. These patients really were Moreover, patients in the phase III COVID-19 study were allowed to receive standard of care, which was balanced between the <unk> and placebo groups with approximately 80% receiving dexamethasone and about 30%.

We see even when desert beer, that's high death rates in the placebo group demonstrate the inadequacy of the current standard of care.

<unk> planned to publish the secondary efficacy endpoints in a peer reviewed medical journals practical to visibly. So this view when treatment was well tolerated in this patient population with no clinically relevant safety observations in the <unk> treated group compared to placebo.

Mitchell Steiner: We had a pre-emergency use authorization meeting with FDA on May 10th to discuss the next steps, including the submission of an emergency use authorization application. The outcome of this meeting is as far as FDA agrees that no additional efficacy studies are required to support an EUA or a full NDA. FDA agreed that no additional safety data is required to support an EUA, and the collection of safety data under the EUA will satisfy the safety requirement for a full NDA.

We had a pre emergency use authorization meeting with FDA on may 10th to discuss next steps, including the submission of an emergency use authorization application yeah I'll come to this meeting is as follows.

The FDA agreed that no additional efficacy studies are required to support an EUA or a or a full NDA FDA agreed that no additional safety data required to support an EUA and collection of safety data under the EUA will satisfy the safety requirement for full NDA.

Mitchell Steiner: Therefore, FDA agreed that the request for EUA is supported by efficacy and safety data from our positive phase 3 COVID-19 study and hospitalized moderate to severe COVID-19 patients with high risk for ARDS, and no additional clinical studies are required to support an NDA submission. We plan to submit the EUA application in this quarter. Furthermore, we have scaled up manufacturing processes to produce commercial drug supply to address the anticipated drug needs following a potential FDA authorization in the U.S. and a potential subsequent authorization in other countries and territories.

Therefore, FDA agreed that the request for EUA is supported by efficacy and safety data from our positive phase III COVID-19 study and hospitalized moderate to severe COVID-19 patients with high risk <unk> and no additional clinical studies are required to support an NDA submission.

We plan to submit the EUA application in this quarter.

Furthermore, we have scaled up manufacturing processes to produce commercial drug supply to address the anticipated drug needs. Following a potential FTA authorization in the U S and a potential subsequent authorizations in other countries and territories.

Mitchell Steiner: We're also making progress building out our own U.S. commercial infectious disease franchise. We are actively seeking an advance purchase agreement with the U.S. government. In fact, we're meeting with government officials. Usually, an advance purchase agreement is awarded after emergency use authorization is received.

We're also making progress building out our own U S. Commercial infectious disease franchise. We are actively seeking an advance purchase agreement with the U S. Government in fact with meeting with government officials usually in advance purchase agreement is awarded after emergency use authorization is received while also moving forward to submit regulatory applications to the.

Mitchell Steiner: We're also moving forward to submit regulatory applications to the MHRA in Britain and to the COVID-19 European Medicines Agency Pandemic Task Force for the European Union, as well as other countries. We're in discussions with numerous potential distribution partners. COVID-19 Global Cases, Hospitalizations, and Deaths on the Rise Again. We have reached a sad milestone.

MH <unk> in Britain and to the COVID-19 European Medicines Agency pandemic task force for the European Union as well as other countries. We're in discussions with numerous potential distribution partners COVID-19, global cases, hospitalizations and deaths on the rise again.

We have reached a sad milestone over 1 million Americans have died from COVID-19, we must reduce the risk of death, and COVID-19, new variance of COVID-19, a brewery COVID-19 surgeries will happen.

Mitchell Steiner: Over 1 million Americans have died from COVID-19. We must reduce the risk of death from COVID-19. New variants of COVID-19 are brewing. COVID-19 surges will happen. Vaccines are not enough, and some of the antibody drugs are not effective against omicron variant BA1 or BA2.

Vaccines are not enough.

Some of the antibody drugs are not effective against Omar Khan variant be a one or two and as I already pointed out antivirals, perhaps a little bit longer peer review or targeted pre hospital generally general population, who has experienced less than five days of symptoms and narrow window of opportunity is clear that in.

Mitchell Steiner: And as I already pointed out, antivirals Paxilovan and Monopiravir target the pre-hospital general population who've experienced less than five days of symptoms, a narrow window of opportunity. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 infection when the risk for ARDS and death is desperately needed. We strongly believe that Subizubulin, with its dual antiviral and anti-inflammatory properties, can be a greatly needed oral therapy for hospitalized moderate to severe COVID-19 patients as a new standard of care.

Effective and safe oral therapeutic that prevent stats in hospitalized patients with moderate to severe COVID-19 infection with hybris with Rds and death is desperately needed.

We believe it's a busy bulin with its dual antiviral and anti inflammatory properties can be that greatly needed oral therapy for the hospitalized moderate to severe COVID-19 patients as a new standard of care.

Mitchell Steiner: We will continue to update you on the regulatory progress towards EUA in the U.S. and other countries, manufacturing, additional clinical data release and publications, BARDA and other government agency discussions, U.S. and global distribution plans, and partnership discussions. Furthermore...

We will continue to update on the regulatory update you on the regulatory progress towards EUA in the U S and other countries manufacturing additional clinical data release and publications BARDA and other government agency discussions U S and global distribution plans and partnership discussions.

Furthermore.

Mitchell Steiner: Given these exceptional clinical efficacy and safety results, we plan to initiate new clinical studies against 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, also known as RSV, which causes 14,000 deaths and 177,000 hospitalizations each year in the United States. These new clinical studies will allow us to expand sibizibulin to other large, serious I will briefly discuss the progress of our oncology drug portfolio focused on breast and prostate cancers.

Given these exceptional clinical efficacy and safety results, we plan to initiate new clinical studies against other viruses that cause rgs, including influenza a virus, which causes up to 52000 deaths.

710000, hospitalizations each year in <unk>.

Respiratory syncytial virus also known as RSV, which causes 14000 deaths and 177000 hospitalizations each year in the United States.

These new clinical studies will allow us to expand <unk> into other large serious infectious disease indications.

I will briefly discuss the progress of our oncology drug portfolio focused on breast and prostate cancers for patients with greater than or equal to 40% <unk> expression. We are actively enrolling a global phase III. Our test registration clinical study in approximately 210 patients to evaluate and Novus arm monotherapy for the third.

Mitchell Steiner: For patients with greater than or equal to 40 percent AR expression, we are actively enrolling a global phase III R-test registration clinical study in approximately 210 patients to evaluate Inovasar monotherapy for the third-line treatment of AR positive, ER positive, HER2 negative metastatic breast cancer.

<unk> treatment Ah.

Our positive ER positive her two negative metastatic breast cancer in January of 2022, FDA granted fast track designation to our phase III, our test registration program.

Mitchell Steiner: In January of 2022, FDA granted fast-track designation to our phase III R-test registration program. We're also moving in novus arm therapy earlier in the treatment sequence into the second line treatment setting, the AR positive, ER positive, HER2 negative metastatic breast cancer. We are actively enrolling in the phase three multi-center open-label randomized one-to-one active control registration, enable the two clinical study to evaluate the efficacy and safety of a novus arm and a bemacyclic combination therapy versus an alternative estrogen blocking agent in subjects with AR positive, ER positive, HER2 negative metastatic breast cancer who have failed first-line therapy with pablocyclib, a CDK46 inhibitor, plus an estrogen blocking agent who have greater than or equal to 40% error expression in their breast cancer tissue.

We're also moving and nobody's on therapy earlier in the treatment sequence into the second line treatment setting. They are positive ER positive <unk> negative metastatic breast cancer. We are actively enrolling in the phase III Multicenter open label randomized one to one active control registration enabled two clinical study to evaluate the <unk>.

Efficacy and safety of <unk>, and the <unk> combination therapy versus an alternative estrogen blocking agent in subjects with a positive ER positive <unk> negative metastatic breast cancer, who have failed first line therapy with Pablo sick with a CDK four six inhibitor plus an estrogen blocking agents who have greater than that.

40% are expression in breast cancer tissue and plan to enroll approximately 186 subjects in this phase III clinical study.

Mitchell Steiner: We plan to enroll approximately 186 subjects in this phase three clinical study. We recently announced that we have entered into a clinical trial collaboration and supply agreement with Lilly for the Enabler 2 phase 3 clinical study. And under the terms of the non-exclusive clinical trial collaboration and supply agreement, Vera is responsible for conducting the clinical trial, while Lilly will supply bemacite cyclib for the study. Vera maintains full exclusive global rights to Innova.

We recently announced that we've entered into a clinical trial collaboration and supply agreement with Lilly.

The enabler to clinical enabled two phase III clinical study and under the terms of the nonexclusive clinical trial collaboration and supply agreement Bureau is responsible for conducting a clinical trial with Lilly will supply demonstrate sick live for the for.

For the study room maintains full exclusive global rights to <unk>.

Mitchell Steiner: We've also made great progress in our prostate cancer programs. Our first indication is evaluating Subizubulin for the third-line treatment of metastatic, castration-resistant prostate cancer in the Veracity Phase III study. We will be presenting final clinical data from the positive Phase 1b2 study of subisibulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel antigen-receptor-targeted agent at the ASCO conference being held in June of 2022 in Chicago, Illinois.

We've also made great progress in our prostate cancer programs. Our first indication is evaluating <unk> for the third line treatment of metastatic castration resistant prostate cancer in the veracity phase III study.

We will be presenting final clinical data from the positive phase <unk> study of <unk> and 80 men with metastatic castration resistant prostate cancer, who have progressed on at least one novel antigen receptor targeted agent at the Astro Conference being held June of 2022 in Chicago, Illinois.

Mitchell Steiner: We are actively enrolling an open-label, randomized 2-to-1 multicenter Phase 3 veracity clinical study evaluating subisibulin 32 mg versus an alternative antigen-receptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castrate-resistant prostate cancer who have had tumor progression after previously receiving at least one angioreceptor-targeted agent. The primary endpoint is radiographic progression-free survival; enrollment for the phase three veracity clinical studies is on track, and we expect to enroll approximately 245 patients from 45 clinical centers in the U.S. Our second clinical study in prostate cancer is evaluating VIRA-100, a GnRH antagonist three-month depot formulation, in a phase two dose-binding clinical study for the treatment of hormone-sensitive advanced prostate cancer. We're conducting a Phase II Dose Finding Clinical Study of Year 100 androgen deprivation therapy in 45 men with hormone-sensitive advanced prostate cancer.

Activity enrolling an open label randomized two to one multicenter phase III veracity clinical study evaluating <unk> in 32 milligrams versus an alternative androgen receptor targeted agent for the treatment of chemotherapy naive men with metastatic castrate resistant prostate cancer, who have had tumor progression and.

Previously receiving at least one androgen receptor targeted agent that primary endpoint as radiographic progression free survival enrollment for the phase III <unk> clinical studies on track and we expect to enroll approximately 245 patients from 45 clinical centers in the U S.

Our second clinical study in prostate cancer is evaluating <unk> 100, a gnrh antagonist three month depot formulation and a phase two dose finding clinical study for the treatment of hormone sensitive advanced prostate cancer, we're conducting the phase II dose finding clinical study of VB 100, androgen deprivation therapy and <unk> 44.

Five men with hormone sensitive advanced prostate cancer. Although this study is ongoing the preliminary clinical data are promising.

Mitchell Steiner: Although this study is ongoing, the preliminary clinical data are promising. The Phase III registration clinical study design has already been agreed upon with FDA. It will be a single-arm study that will enroll approximately 100 men. Maintenance of castrate blood concentrations of testosterone is the primary endpoint.

The phase III registration clinical study design has already been agreed upon with the FDA. It will be a single arm study, which will enroll approximately 100 men maintenance of castrate blood concentrations of testosterone as the primary endpoint and after the phase two dose finding study is completed we will initiate the phase III clinical study.

Mitchell Steiner: And after the Phase II dose-finding study is completed, we will initiate the Phase III clinical study. Veru has a commercial sexual health division called UREV, which includes two FDA-approved products, the FC2 for dual protection against unplanned pregnancy and transmission of sexual transmitted infections, and the recently FDA-approved Entafi, which is Tadalfil finasteride capsule, a new treatment for benign prostatic hyperplasia. We have built the infrastructure to allow for broad market access for FC2 across the U.S. As a result, FC2 is now available through multiple sales channels.

<unk> has a commercial sexual health division called <unk>, which includes two FDA approved products. The FC too for the dual protection against unplanned pregnancy and transmission of sexually transmitted infections and the recently FDA approved and taxi, which is to downfield finasteride capsule and new treatments with benign prostatic hyperplasia.

We have built the infrastructure to allow for broad market access to <unk> across the U S. As a result, <unk> is now available through multiple sales channels. In particular, we have partnered with fast growing highly reputable telemedicine platform companies to bring our MCT product to patients in a cost effective highly convenient manner.

Mitchell Steiner: In particular, we have partnered with fast-growing, highly reputable telemedicine platform companies to bring our FC2 product to patients in a cost-effective, highly convenient manner. A strategy to continue to drive robust FC2 sales is not only to seek additional telemedicine and internet pharmacy service partners but also to create our own direct-to-patient, Telemedicine and Internet Pharmacy Services Platform. This telemedicine platform is now up and running and is expected to be a new source of revenue. You've also developed Tad, a new treatment for BPH. The most common side effects of currently prescribed BPH medicines are sexual adverse events, including impotence.

Our strategy to continue to drive robust FCC to sales is not only the seek additional telemedicine and Internet pharmacy service partners, but also to create our own direct to patient.

Telemedicine and Internet Pharmacy services platform. This telemedicine platform, which is now up and running and is expected to be a new source of revenue.

It also developed in taxi.

New treatments with BPH. The most common side effects of currently prescribed BPH medicine, as a sexual adverse events, including impetus and taxi has been shown to be more effective for the treatment of BPH than finasteride alone without causing impotence and taffy was approved by FDA in December of 2021, the plan is to.

Mitchell Steiner: Intafi has been shown to be more effective for the treatment of BPH than finasteride alone without causing impotence. It was approved by the FDA in December of 2021. The plan is to officially launch Intafi next quarter. We are waiting for the FDA to sign off on the manufacturing release criteria for the Intafi commercial product. Intafi is expected to be marketed and distributed by a third-party direct-to-patient telemedicine and internet pharmacy services platform partnership.

Officially launch in taxi next quarter, we are waiting for the FDA to sign off on the manufacturing and release criteria for the entire fee commercial product <unk> is expected to be marketed and distributed by third party direct to patient telemedicine Internet Pharmacy services platform partnership. We are we have also partnered with good Rx.

Mitchell Steiner: We have also partnered with GoodRx, a U.S.-based digital resource for health care, to reach their almost 20 million monthly visitors, which include both consumers and health care providers, to build awareness about Entafi. There are over 45 million prescriptions filled annually for drugs that treat benign prostatic hyperplasia. We plan to augment our marketing and sales efforts by seeking additional partners in the U.S. and abroad. I will now turn the call over to Michele Greco, CFO, and CAO, to discuss the financial highlights. Michele?

Our U S based digital resource for health care to reach their almost 20 million monthly visitors, which include both consumers and health care providers to build awareness about and taffy. There are over 45 million prescriptions filled annually for drugs to treat BPH, we plan to augment our 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 C E O.

To discuss the financial highlights Michelle.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we're having a great year. Let's start our highlights with the second quarter results for the three months ended March 31, 2022. Overall, net revenues were $13 million compared to $13.3 million in the prior year's second quarter.

You'd have to Steiner and factor Steiner indicated we're having a great year lets start our highlights for the second quarter results for the three months ended March 31 2022.

Overall, net revenues were $13 million compared to $13 $3 million in the prior year second quarter.

Michele Greco: The company reported quarterly sales for its U.S. prescription business of $11.6 million, an increase of 12% from $10.3 million in the prior year's second quarter. Overall gross profit was $11.2 million, or 86% of net revenues compared to $10.9 million or 82% of net revenues in the prior year quarter. This was our highest gross margin for any quarter. The increase in gross profit and gross margin was driven primarily by increased sales in our USFC2 prescription business.

The company reported quarterly sales for its U S prescription business of $11 $6 million, an increase of 12% from $10 $3 million in the prior year second quarter.

Overall gross profit was $11 $2 million or 86% of net revenues compared to $10 9 million or 82% of net revenues in the prior year quarter. This was our highest gross margin for any quarter.

The increase in gross profit and gross margin is driven primarily by increased sales in our U S FC two prescription business.

Michele Greco: We saw a decrease in sales in the global public sector during the quarter due primarily to 2.8 million units sold to Brazil in the prior year period for tenders, which have ended and therefore did not repeat in the current year. Operating expenses for the quarter increased to $22.9 million compared to the prior year quarter of $12.4 million.

We saw a decrease in sales in the global public sector during the quarter due primarily to a $2 8 million units sold to Brazil in the prior year period for tenders, which have ended and therefore did not repeat in the current year.

Operating expenses for the quarter increased to $22 $9 million compared to the prior year quarter of $12 $4 million.

Michele Greco: The increase of $10.5 million is primarily due to research and development costs, which increased $7.9 million to $15.5 million compared to $7.6 million in the prior year quarter. The increase in research and development costs is due to an 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 II clinical trials ongoing. The operating loss for the quarter was $11.8 million compared to $1.5 million in the prior year quarter.

The increase of $10 $5 million, primarily due to research and development costs, which increased $7 $9 million to $15 $5 million compared to $7 6 million in the prior year quarter.

The increase in research and development cost is due to the increased number of clinical trial. This quarter, we had four phase III clinical trial and two phase II clinical trials ongoing while in the prior period, we had two phase two clinical trials ongoing.

The operating loss for the quarter was $11 $8 million compared to $1 $5 million from the prior year quarter.

Michele Greco: Non-operating expenses were $2.4 million compared to $1.4 million in the prior year's second quarter 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 quarter, we recorded a tax benefit of $27,000 compared to a tax expense of $22,000 in the prior year's second quarter. The bottom line result for the second quarter of fiscal 2022 was a net loss of $14.2 million, or $0.18 per diluted common share, compared to a net loss of $2.8 million, or $0.04 per diluted common share, in the prior year's second quarter.

Non operating expenses were $2 $4 million compared to $1 $4 million.

Our second quarter, 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 quarter, we recorded a tax benefit of $27000 compared to a tax expense of $22000 in the prior year second quarter the bottom line.

Results for the second quarter of fiscal 2022, with a net loss of $14 $2 million or <unk> 18 per diluted common share compared to a net loss of $2 $8 million or <unk> per diluted common share in the prior year second quarter.

Michele Greco: Now turning to highlights for the results for the six months ended March 31st, 2022. For the first six months of fiscal 2022, total net revenues were $27.2 million, compared to $28 million in the prior year period. Net revenue from the U.S. prescription business was up 19% to $23.2 million from $19.4 million in the prior year period. Overall, gross profit was $23 million, or 85% of net revenues, compared to $21.7 million, or 78% of net revenues in the prior year period.

Now turning to highlights for the results for the six months ended March 31 2022.

For the first six months of fiscal 2022 total net revenues were $27 $2 million compared to $28 million in the prior year period.

Net revenue from the U S prescription business was up 19% to $23 $2 million from $19 $4 million in the prior year period.

Overall gross profit was $23 million or 85% of net revenues compared to $21 7 million or <unk>, 78% of net revenues in the prior year period.

Michele Greco: The increase in profit and gross margin is due primarily to the increase in the U.S. prescription business. However, we saw a decrease in sales in the global public sector during the first half of the year due primarily to 6.9 million units sold to Brazil and 1.8 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. Operating expenses increased by $17.3 million to $39.7 million compared to the prior year period of $22.4 million.

The increase in profit and gross margin is due primarily to increase in the U S prescription business.

We saw a decrease in sales in the global public sector. During the first half of the year due primarily to $6 9 million itself to Brazil, and $1 8 million more units, So south Africa in the prior year period for tenders, which have ended and therefore did not repeat in the current year.

Operating expenses increased by $17 3 million to $39 $7 million compared to the prior year period of $22 $4 million.

Michele Greco: The increase is primarily driven by research and development costs, which increased by $12.3 million to $25.6 million from $13.3 million in the prior year period. The increase in research and development costs is due to the increased number of clinical trials, which I previously discussed. Operating loss for the period was $16.7 million compared to an operating income of $17.7 million in the prior year period.

The increase was primarily driven by research and development costs, which increased by $12 $3 million to $25 6 million from $13 $3 million in the prior year period.

The increase in research and development cost is due to the increased number of clinical trials, which I previously discussed.

Operating loss for the period was $16 $7 million compared to an operating income of $17 7 million in the prior year period.

Michele Greco: The change of $34.4 million is primarily due to the gain on sale of pre-boost of $18.4 million in the prior year period and the increase in research and development costs during the current year period. Non-operating expenses were $3.7 million compared to $3.2 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 this six-month period, we recorded a tax expense of $87,000 compared to $100,000 in the prior year period.

Change of $34 $4 million is primarily due to the gain on sale of <unk> of $18 $4 million in them.

Higher year period, and the increase in research and development costs during the current year period.

Non operating expenses were $3 7 million compared to $3 $2 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 six months period, we recorded a tax expense of $87000 compared to $100000 in the prior year period.

Michele Greco: The company has net operating loss carry-forwards for U.S. federal tax purposes of $38.6 million, with $29.5 million expiring in years through 2040 and $9.1 million which can be carried forward indefinitely. Additionally, a UK subsidiary has net operating loss carry-forwards of $63.5 million which do not expire. The bottom line result for the first six months of fiscal 2022 was a net loss of $20.6 million, or $0.26 per diluted common share, compared to net income in the prior period, which included a gain on sale of pre-boost of $14.4 million, or $0.18 per diluted common share.

The company has net operating loss carryforwards for U S. Federal tax purposes of $38 $6 million with $29 5 million expiring in years through $2049 $1 million, which can be carried forward indefinitely.

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

The bottom line result for the first six months of fiscal 2022 with a net loss of $20 6 million or 26 per diluted common share compared to net income in the prior period, which included the gain on sale of peoples of $14 $4 million or <unk> 18 per diluted common share.

Michele Greco: Turning to our balance sheet, as of March 31, 2022, our cash balance was $112 million, and our accounts receivable were $8.1 million, and our note receivable related to the sale of Preboost was $2.5 million. Our net working capital was $119.3 million on March 31, 2022, compared to $136 million on September 30, 2021. During the six months ended March 31, 2022, we used cash of $12.6 million for operating activities, compared with $1.9 million used for operating activities in the prior period.

Turning to our balance sheet as of March 31, 2022, our cash balance was $112 million.

Our accounts receivable were $8 1 million in our note receivable related to the sale of <unk> was $2 $5 million. Our net working capital was $119 3 million on March 31, 2022, compared to $136 million at September 32021.

The six months ended March 31, 2022, we used cash of $12 6 million for operating activities compared with $1 9 million used for operating activities in the prior period.

Michele Greco: The expected future revenues from Subizubulin for COVID-19, the continued revenue from sales in the USFC2 prescription business, and the global public sector business, coupled with the expected future revenue from Larkvin-Tadphy and added to our strong balance sheet, should continue to be the source of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium biopharmaceutical company focused on developing novel medicines Now, I'd like to turn the call back to Dr. Steiner.

The expected future revenues from <unk> for COVID-19 that continued revenue from sales in the U S. FC two prescription business and the global public sector business, coupled with the expected future revenue from the life and P&C and add it to our strong balance sheet should continue to be the source of funds we used.

To invest in our promising pharmaceutical clinical development programs.

We continue to transform our company into a premier premium biopharmaceutical company focused on developing novel medicines for COVID-19, and other viral and <unk> 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 Michelle and summary, we.

Michele Greco: In summary, we continue to advance our deep late clinical stage breast cancer and prostate cancer programs with three actively enrolling phase three clinical studies, and we will continue to grow revenue from our base sexual health business and have authorized future revenue from Subizubulin for hospitalized COVID-19 patients at risk for ARDS. Being opportunistic and successful in developing subizabulin COVID-19 has led to the most eventful and transformative quarter in Veru's history.

To advance our deep late clinical stage breast cancer and prostate cancer programs with three actively enrolling phase III clinical studies and we will continue to grow revenue from our base sexual health business and if authorized for future revenues.

Bulent for hospitalized COVID-19 patients at risk for <unk>.

Yes.

Being opportunistic and successful in developing <unk> and COVID-19 has led to the most eventful and transformative quarter in <unk> history. We are preparing for the global commercial launch of <unk> nine milligrams for the treatment of hospitalized moderate to severe COVID-19 patients with high risk <unk>, we have created and infer.

Michele Greco: We are preparing for the global commercial launch of subizabulin 9 milligrams for the treatment of hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS. We have created an infectious disease franchise for this purpose. This is anticipated to be a worldwide multi-billion dollar opportunity. This will be a real chance for significant near-term revenue for Veru.

<unk> disease franchise for this purpose.

As anticipated to be a worldwide multibillion dollar opportunity this will be a real chance for significant near term revenue for the room.

Mitchell Steiner: I would like to directly respond to several criticisms that have been made about the Phase 3 COVID-19 clinical trial. Concern number one: The mortality rate is too high in the placebo group. Not true.

I would like to.

Directly respond to several criticisms that had been made about the phase III COVID-19 clinical trial <unk>.

Concern number one the mortality rate is too high in the placebo group.

Not true.

Mitchell Steiner: The placebo death rates in our phase three study are consistent with what has been reported in the literature for similar patients at day 29. As mentioned previously, at day 29, the death rate in the placebo group in our study was 35%, which is the same death rate as reported in the Lancet publications of May 2021 for the placebo group of similar hospitalized patients consisting of 2,094 patients for the Tocilizumab recovery study.

Cebu deaths death rates in our phase III study are consistent with what has been reported in the literature for similar patients at day 29 as mentioned previously at day 29, the death rate in the placebo group in our study was 35% which is the same death rate as reported in the lancet publication from May 2021.

For the placebo group of similar hospitalized patients consisting of 2094 patients for the <unk> Mab recovery study.

Mitchell Steiner: Furthermore, one would expect the death rate in the placebo group at day 60 of our trial to be higher than the day 29 death rate. Concern number two, death rates were higher in the ex-U.S. clinical sites than for the U.S. clinical sites. This was not true.

Furthermore, one would expect the death rate in the placebo group a day 60 of our trial to be higher than the day 29 death rate.

Concern number two death rates were higher and the ex U S clinical sites for the U S clinical sites not true.

Mitchell Steiner: The death rates in the placebo group were higher in the U.S. clinical sites compared to clinical sites outside the U.S. Furthermore, the reduction in the risk of death between the U.S. and ex-U.S. clinical sites by sibizibulin was the same in the U.S. compared to ex-U.S. This will be clear when our data are published in a peer-reviewed medical journal. Concern number three. Our phased clinical trial held no standard of care requirements.

The death rates in the placebo group were higher in the U S clinical sites compared to clinical sites outside the U S. Furthermore, the reduction in the risk of death between the U S and ex U S clinical sites by <unk> was the same in the U S compared to ex U S.

This will be clear when our data are published in a peer reviewed medical journal.

Concern number three.

Mitchell Steiner: Not true. Standard of care was allowed for both the placebo and treatment groups. Standard of care was well-balanced between the treatment and placebo groups. Approximately 80% of patients received dexamethasone, and about 30% received remdesivir. Other agents, including anti-IL-6 antibodies and JAK inhibitors, were also allowed, and Bishop Ewing demonstrated clear benefit over standard of care, sharingin number 4. However, there is a high risk that the FDA will not accept an EUA application because our Phase 3 study was too small. Not true.

Our phase <unk> clinical trial held held no standard of care requirements not true standard of care was allowed for both the placebo and treatment groups standard of care was well balanced between the treatment and placebo groups approximately 80% receive dexamethasone about 30% received <unk>.

Other agents, including anti IL, IL <unk> antibodies and JAK inhibitors will also allowed.

<unk> demonstrated clear benefit over standard of care.

Starting up before.

There is a high risk that the FDA will not accept an EUA application because our phase III study was too small.

Mitchell Steiner: As we have previously reported, we had a pre-EUA meeting with FDA on May 10, 2022. FDA agreed that no additional efficacy studies are required to support an EUA or an NDA. FDA agreed that no additional safety data was required to support an EUA and a collection of safety data under the EUA will satisfy the safety requirement for an NDA. Therefore, FDA agreed that the request for an EUA is supported by efficacy and safety data from our positive phase 3 COVID-19 study and hospitalized moderate to severe COVID-19 patients with high risk for ARDS, and no additional clinical trials are required to support an NDA submission. Short sellers might like to rob investors of unfounded criticism.

Not true as we've previously reported we've had a pre EUA meeting with FDA on May 10, 2022, FDA agreed that no additional efficacy studies are required.

To support an EUA or an NDA or an NDA FDA agreed that no additional safety data required to support an EUA and a collection of safety data under the EUA, we'll satisfy the safety requirement for an NDA.

Therefore, FDA agreed that the request for EUA is supported by efficacy and safety data from our positive phase III COVID-19 study and hospitalized moderate to severe COVID-19 patients with high wished with Rds and no additional clinical trials are required to support an NDA submission.

Short sellers might like to lob unfounded criticisms, but our audience as the FDA will help develop the study design and who have now told us that the data are sufficient to proceed as patients are waiting we will work diligence diligently preparing to submit the EUA application now that we received the green light and <unk>.

Mitchell Steiner: But our audience is the FDA, who helped develop the study design and who have now told us that the data are sufficient to proceed. Since patients are waiting, we will work diligently to prepare and submit the EUA application now that we have received the green light and encouragement to do so from FDA. With that, I'll now open the call to questions. Ladies and gentlemen, at this time, we will begin the question and answer session.

<unk> to do so from FDA.

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

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

Mitchell Steiner: To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

You asked a good question.

And one on your telephone keypad.

If you are using a speaker phone we ask that you. Please pickup your handset before pressing the key to <unk>.

The best sound quality.

Operator: To withdraw your question, please press star, then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is stars and ones to rejoin the question queue. We will pause momentarily to assemble our roster. The first question today comes from Brandon Foulkes with Cantor Fitzgerald. Please go ahead. Ah, thanks for taking my questions and congratulations on all the progress. Um, maybe just sort of focus on the same thing for me.

To withdraw your question. Please press Star then two.

Please limit yourself to one question and one follow up.

If you have further questions you may reenter the question queue.

Once again that is star one to rejoin the question queue.

We will pause momentarily to assemble our roster.

Brandon Foulkes: So Mitch, you sound very confident on the manufacturing side. Can you just give us some additional detail in terms of how you thought about the addressable market, you know, I guess, what capacity do you need to satisfy FDI in this EUA? And then, along those lines, with your partner, are you putting any capital at risk for reservation of capacity or anything like that ahead of the EUA? Thank you. Good, thank you. So the first question is basically about manufacturing.

The first question today comes from Brandon Folkes with Cantor Fitzgerald. Please go ahead.

Alright, Thanks, taking my questions and congratulations on all the progress.

Maybe just sort of to focus on the same thing Amit to meet you sound very confident on the manufacturing side can you just give us.

Some.

Additional detail in terms of how you thought about the addressable market I guess.

What capacity do you need to satisfy the <unk> right and then secondly, along those lines with your partner are you, putting any capital at risk or reservation of capacity or anything like that hit of the EI. Thank you.

Mitchell Steiner: So I'm going to answer it two ways. One, I'm going to tell you how we think the patient numbers are going to be. If this was a pandemic, more, more like an endemic, this doesn't include the surge doesn't include stockpileing doesn't include any of that. So just this way, you have a rule of thumb, a benchmark.

Good. Thank you. So the first question is basically about manufacturing and so I'm going to answer it two ways, one I'm going to I'm going to answer with how we what we think the patient numbers are going to be.

If this was a pandemic.

More like an endemic this doesn't include the surge doesn't include stockpiling. It doesn't include any of that so this way you have it.

A rule of thumb.

Benchmark so in the United States right now.

Mitchell Steiner: So in the United States right now, when we did the analysis, we said the hospitalization rate is about 1,955 new admissions a day. That number, by the way, has gone up to 2,597 as I looked at it this morning, but we're going to stick with the lower number, 1,955. And the number of patients that are hospitalized that would benefit from supplemental oxygen, forced oxygen, or ventilation is about 52% of hospitalizations. And so that means for that week, if you look at it per week, it's about 7,116 patients a week. So for the month... You're looking at close to 28,000.

The when we did the analysis, we said the hospitalization rate is about 101955, new admissions a day that number by the way it's gone up to 2597 as I looked at it this morning about but we're going to stick with the lower number.

$19 55, and the number of paid the patients that are hospitalized it would fit supplemental oxygen force oxygen or ventilation is about 52% of hospitalizations and so that means for that week. If you look at it per week, it's about 7116 patients a week.

So for the month.

Youre looking at close to 28464 patients. Okay. That's before this new surge, it's becoming so if you think if you say the rule of thumb is that we've got in the U S. We've got to hit about 30000 patients that will give you.

Mitchell Steiner: 464 patients. Okay, that's before this new surge that's coming. So if you think to yourself, if you say the rule of thumb is we've got to, in the U.S., we've got to hit about 30,000 patients, that will give you a feel for how well we've been able to accelerate our manufacturing. So I'm going to ask Dr. Gary Barnett to give you some insight into how robust our manufacturing is and how we'll be ready. And there's no capital at risk.

Feel for how well, we'd be able to accelerate our manufacturing so I'm going to ask Dr. Gary Barnett.

To give you some insight in how and how robust.

Our manufacturing is and how it will be ready and there is no capital at risk. There is no capital at risk go ahead, yes, so we've been planning.

Mitchell Steiner: Go ahead. Yeah, so we've been planning for this EUA, and right now, in the month of July, we would have approximately 50,000 patients' worth of drug. This is assuming that a patient gets about 12 doses, which is approximately the average number of doses that each patient in the treated group got in our phase 3 study.

For the for this EUA.

Now in the month of July we would have approximately 50000 patients worth of drug. This is assuming a patient get about 12 doses, which is approximately the average number of doses that each patient in the treated group.

Gary Barnett: In August, we would have sufficient drug for an additional 100,000 patients. And then, moving forward, up to approximately 250,000 patients' worth of drug every 30 days. We believe that this will satisfy and cover the addressable market in the United States as well as the rest of the world.

In our phase III study in August we would have sufficient drug an additional 100000 patients and then from September moving forward up to approximately 250000 patients worth of drug every 30 days.

We believe that this will.

We will satisfy and cover the addressable market in the United States as well as the <unk>.

Rest of World and also it will help towards stockpiling. So people can be prepared for the surge. If there is a surge and we are going to you know.

Mitchell Steiner: And also, it will help towards stockpiling so people can be prepared for the surge. If there's a surge, as you saw with the surge we just had, right now, the problem, of course, that we have is that people are taking home testing. And so we don't really understand where the hospitalizations may peak, and we'll just have to watch that.

As you saw with the surge we just had.

And right now the problem of course that we have is that people are taking home testing and so we don't really understand where the hospitalizations might peak.

Mitchell Steiner: But at this point now, assuming that the authorization, if it is authorized, will happen in sort of mid-summer, then we'll be ready. Great, thanks very much, and all the best for the submission. Thank you.

And we'll just have to watch that.

But at this point now assuming all assuming that the authorization.

It's authorized will happen in sort of mid summer.

Then then it will be ready.

Great. Thanks, so much and will this tool and submission.

Thank you.

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

Chris Howerton: Please go ahead. Excellent. Thank you so much for taking the questions, and I will also offer my congratulations.

Excellent. Thank you so much for taking the questions and I will also offer my congratulations. Thank you yeah. So for I guess, Mitch with respect to the <unk> program and in COVID-19.

Chris Howerton: Thank you. For, yeah, so for, I guess, Mitch, with respect to the the Subizabulen program in COVID-19, I wanted to follow up on the manufacturing question just to kind of understand if there was any inspections that might be required and I think at least it's a little vague to me in terms of the process of CMC evaluation for an EUA, so I guess if you could just help us understand what procedural steps from your understanding might be happening on the CMC side for the review, that would be really helpful. Yep, we'll do that. So Gary?

I wanted to follow up on the manufacturing question just to kind of understand if there was any inspections that might be required and I think at least its a little vague to me in terms of the process of CMC.

Evaluation for an EUA. So I guess, if you could just help us understand what procedural steps from your understanding might be happening on the CMC side.

For the review that would be really helpful. Yeah, we'll do that so Gary yes.

Mitchell Steiner: Yeah, you know, the FDA has to have regulatory rigor for any kind of authorization or approval. However, with what we believe to be the accelerated process of the EUA, we believe that that will, you know, the inspection piece will be minimal. Of course, the sites that we're using have a long record of FDA inspections and a history of quality at their sites.

The FDA has to have.

Katori rigor and any kind of authorization or approval, however, with what we believe to be the accelerated process.

We believe that that will.

Inspection piece will be minimal of course.

These sites that we're using have a long record with FDA inspections, and a history of of quality at their site. So we do believe that as we move forward to the NDA the FDA will.

Gary Barnett: So we do believe that as we move forward with the NDA, the FDA will probably do a pre-approval inspection of our facilities, but right now, I suspect that they will rely on the long history that they have with these facilities to support the application. You know, one of the interesting things I was able to take away from the meeting with the FDA is how they view this process as sort of a, you know, ultimately getting to a full NDA is sort of a rolling process.

Probably do a preapproval inspection of our of our facilities, but right now I suspect.

We will rely on the long history that they have with these facilities to support the application.

The interesting thing is I was able to take away from the meeting from the FDA is how they view this process as sort of a.

Ultimately getting to a full NDA as sort of a rolling process to rolling process means if you have it you can file if you submit an NDA under normal circumstances.

Gary Barnett: So the rolling process means that if you submit an NDA under normal circumstances, you have to have everything done, buttoned up, and in it goes, and the full application comes in, and 75 days later, they review everything, and they tell you they can review it, and you move forward.

You have to have everything done buttoned up and it goes in the full application comes in at 75 days later, they review everything and they tell you. We can review it and you move forward.

Mitchell Steiner: With the fast-track designation and with the potential for the EUA, it's more along the lines of, you know, let's get this thing reviewed as quickly as we can, let's get this to patients as quickly as we can. You know, during the review process and during the movement towards a full NDA, you can keep sending new information, additional information, and additional information. So it's really a rolling kind of situation, so inspections and other things all have to be done in real time as opposed to, you know, you have to get everything together and throw it in, and then you hold your breath.

With the fast track designation and with the potential for the EUA, It's more along the lines of let's get this thing reviews as quickly as we can get this to patients as quickly as we can.

During the review process and during the movement towards a full NDA you can keep sending new information additional information additional information. So it's really a rolling kind of situations. So inspections and other things have to be done can be done in real time as opposed to you have to.

You have to get everything together and through.

So it in and then you hold your breath. So we're going to have which is going to be a very active process.

Mitchell Steiner: So we're going to have, you know, this is going to be a very active process where, you know, success one will be the EUA authorization and ultimately success two will be full NDA and then, you know, and then, and then, and then you're, And it's done, and then you're ready to go. Excellent. Well, that's really helpful.

Where.

Success, one will be the EUA authorization and.

And ultimately success to the full NDA and and and then and then and then then.

And then it's done and then you're ready to go.

Mitchell Steiner: And then, if I may, as a follow-up, what do you think we should be considering pricing for subizobulin in the context of COVID-19 and perhaps broader ARDS? Yeah, it's a great question.

Excellent.

That's really helpful. Thank you and then if I may as a follow up.

What do you think how should we be considering pricing for <unk> and in the context of COVID-19, and perhaps broader alds.

Yeah. It's a great question. So first of all I will tell you that the numbers that we've used and youll see on our website is purely purely assumptions right now we're doing the formal work to get our arms around what should be the appropriate price I will tell you something very interesting for <unk> in general.

Mitchell Steiner: So first of all, I will tell you that the numbers we've used and you'll see on our website are purely, purely assumptions right now. We're doing the formal work to get our arms around what should be the appropriate price. I will tell you something very interesting for ARDS in general. There is no drug on the market that has the reduction in death that this drug demonstrated in our phase three study. And ARDS is what's killing these patients.

There is no drug on the market.

Has the reduction in debt.

This drug demonstrated in our phase III study and <unk> and <unk>.

<unk> is what's killing these patients and so for the first time, it's interesting that sounds and people are not recognizing this antiviral anti inflammatory effect is leading to an unprecedented reduction in deaths in the ICU and critical care for patients with <unk>.

Mitchell Steiner: And so for the first time, interesting as it sounds, and people are not recognizing it, this antiviral, anti-inflammatory effect is leading to an unprecedented reduction in deaths in the ICU in critical care for patients with ARDS, end of story. And if you go back and look, they have supportive care, just like we do for COVID-19, for other virally-infected ARDS. And you have, other than that, they've got some antivirals.

And the story.

And if you go back and look they have they have supportive care just like we do for COVID-19 for other fiber, we introduced <unk> and you have.

Other than that they've got some antivirals and we already know anti Virals a week back moment period here, which is the antiviral that's being used in a pre hospitalized setting.

Mitchell Steiner: And we already know antivirals are weak. In fact, molnupiravir, which is an antiviral that's being used in a pre-hospitalized setting, they had an IDMC meeting, an Independent Data Monitoring Committee meeting. And the conclusion of that committee was to stop the study because there was no efficacy. So it's, you know, the thing about ARDS is the virus triggers this cytokine storm that creates this allergic response, and the lungs start to fill with fluid to a point where they become fibrotic, and they're filled with fluid, and the oxygenation goes down, and the patient dies.

They had an <unk> meeting an independent data monitoring committee meeting and the conclusion that that group that committee was to stop the study because theres no efficacy so.

When you think about <unk> is the virus triggers this.

Cytokines storm that creates this allergic response in the lung start to fill up with fluid to a point do they become fibrotic and filled with fluid and oxygenation goes down and the patient dies and and usually that will happen. After you have the vital part so at some point the viral load is.

Mitchell Steiner: And usually, that'll happen after you have the viral part. So at some point, the viral load is, you know, it doesn't matter; you've already triggered the immune response, and the immune response is what's leading to the demise of the patient, almost like a bee sting causing an anaphylactic reaction. Do you pull the stinger out, or do you give the patient epinephrine, which is not an antiviral and saves the patient's life?

It doesn't matter you've already triggers the immune response and immune responses, what's leading to the <unk>.

<unk> to the patient almost where I could be seen causing an anaphylactic reaction the pull the stinger out.

Did you give the patient epinephrine, which is not an antiviral.

<unk> saves the patient's life.

Mitchell Steiner: And so from that standpoint, ARDS is wide open, and we wanna go after it. With that said, for COVID, what we're doing now is we've commissioned a group to do a formal pricing analysis. And we're also gonna be looking at how it impacts other things in society. So, for example, death is the last step.

And so from that standpoint, <unk> is wide open and we want to go after it with that said for Covid.

What we're doing now is we've commissioned that group to do a formal pricing analysis.

We're also going to be looking at how it impacts other things in society. So for example, remember that is the last step I mean, the whole reason, we're afraid of Covid is not because you get sniffles, we're afraid of COVID-19, because you're going to die and you're afraid of dying, but you're afraid of dying and vaccines helped but it herd immunity.

Mitchell Steiner: I mean, the whole reason we're afraid of COVID is not because you get sniffles. We're afraid of COVID because you're going to die. And you're afraid of dying. Not that you're going to die, but you're afraid of dying.

Mitchell Steiner: And vaccines helped, but herd immunity didn't work. And vaccinating 80% of the patients, still, the patients can get COVID. They can get symptoms of COVID. They can die from COVID. They can pass COVID. It helps. Vaccines are important. Don't take it wrong.

Work and Vaccinating, 80% of the patients still patients can get Covid I think you had symptoms of COVID-19. They can die with COVID-19. The past Covid. It helps vaccines are important don't take it wrong, but it didn't solve the problem.

Mitchell Steiner: But it didn't solve the problem. Antivirals are coming in, in a pre-hospitalized setting, and hopefully, somebody gets the sniffles for three or four days. You get them in that window, and it's an effective drug, but that's a tight window to get in to the doctor, get the prescription, get the prescription filled, and start the medicine. So right now, the last stop, the last opportunity to rescue a patient is in the hospital.

Antivirals are coming in in the pre hospital setting and hopefully somebody gets the sniffles for three or four days you get them in that window and it is an effective drug.

That's a tight window to get into the doctor to get the prescription gets prescription filled and start to medicine.

So right now we're at.

Last stop to the last opportunity to rescue a patient is in is in the hospital. So when a patient comes in hospitalized on oxygen.

Mitchell Steiner: So when a patient comes in hospitalized on oxygen... And you'll see when the publication comes out, the peer-reviewed publication comes out, I will tell you that there will be no surprises in that secondary endpoint. Secondary endpoints all go the way you expect.

You'll see when the publication comes out the peer review publication comes out.

I will tell you there's going to be no surprises in the secondary endpoints secondary endpoints. All go the way you expect if you reduce deaths youre going to reduce ICU youre going to reduce.

Mitchell Steiner: If you reduce deaths, you're going to reduce ICU. You're going to reduce mechanical ventilation. You're going to reduce days in the hospital. I mean, it's intuitive, and it's proven.

Chemical ventilation youre going to reduce days in the hospital I mean, it's intuitive and it's proven.

Mitchell Steiner: And so what I'm trying to tell you is that all of those metrics can be used to understand the impact of the hospital system in terms of what a drug like this can do. And so all of those factors will be built into coming up with a price. So it's hard.

And so what I'm trying to tell you is that all of those metrics can be used to understand the impact of the hospital system in terms of what a drug like this can do and and so all of those factors will be built in to coming up with a price. So it's hard I didn't give you the answer which is what is the price.

Mitchell Steiner: I didn't give you the answer to your question, which is what the price will be, but as you can see, we've got to understand the balance between saving major resources for the system and because, if you think about it, the biggest expenditure for a patient sick with COVID is the hospital. That's the biggest, that's the most intense resources, people, time, money, I mean, materials, I mean, that's where it's happening, and so what we're saying is we want to come up with a fair price, and the system will benefit, but we need to understand what that is. Okay. All right. Well, thanks for those thoughts, Mitch.

But but but as you can see.

We've got a we've got to understand the balance between.

Saving major resources for this for the system because if you think about it the biggest expenditure for a patient six cyclic COVID-19 is the hospital.

That's the biggest that's the most intense resources people time money I mean.

Materials, I mean, that's where it's happening and so so what we're saying is we want to come up with a fair price.

And in our system will benefit, but we need to understand what that is.

Okay, all right well thanks for those thoughts mentioned really appreciate it. Thank you. Thank you.

Chris Howerton: I really appreciate it. Thank you. The next question comes from Leland Gershell with Oppenheimer. Please go ahead. Good morning.

The next question comes from Leland <unk> with Oppenheimer. Please go ahead.

Leland Gershell: Thanks for taking my questions. Mitch, I wanted to ask, as you prepare for the EUA request submission and the manuscripts that will detail the fuller data from Phase 3, are there any pieces of data that you are still awaiting to collect from the sites or to compile, perhaps, viral load data on the patients? And also wanted to ask if you see any possibility of having the manuscript published prior to what may be the EUA granting by the FDA, which presumably could be sometime in the next few months over the summer. Thank you.

Hi, good morning, Thanks for taking my questions.

Wanted to ask as you prepare for the UA request submission.

The menu script that will until the full data from the phase III are there any pieces of data that you are still waiting to collect them.

I'll.

Perhaps viral load data on the patients and also wanted to ask if you see what the possibility you may see of having the manuscript published.

Prior to what may be the EUA granted by the FDA, which presumably could be sometime in the next.

A few months or the summer.

Thank you.

Mitchell Steiner: Yeah, so the answer to your question, the first question is basically, you know, what's outstanding? And as I mentioned to you that we're going to have a few, we just got the data, three weeks ago or something like that.

Yeah. So the answer to your question. The first question is basically whats outstanding and as I mentioned to you that we're going to have a few we just got the data and.

Mitchell Steiner: And so they're going to be a few, when I say outstanding, it's going to be things like PK and, and other things that, you know, sparse sampling, PK, and that kind of stuff. What we, what we understand from the submission for the EUA is all that, as I mentioned in my earlier comment, that's real time; you're allowed to continue to submit information as you get it. So the EUA, you get, you pull out what you have. You submit it, and then as the data comes from the CRO, and you continue to supplement that information while they're doing their review.

Three weeks ago, or something like that and so they're going to be a few outstanding.

Outstanding it can be things like PK and.

And the other things that sparse sampling PK and that kind of stuff.

What we understand from the submission for the EUA is all of that as I mentioned in my earlier comments, that's real time Youre allowed to continue to submit information as you get it. So the EUA you get go what you have you submit it and then you continue which as the data comes from the CRO.

And you continue to supplement that information while they are doing their review. So that's a really critical point. So that's why we have an aggressive timeline to submit the EU the request for EUA as being in this quarter because we.

Mitchell Steiner: So that's a really critical point. So that's why we have an aggressive timeline to submit the request for EUA this quarter because we've got what we need. We're gonna put it together, we're gonna submit it. So from that standpoint, it won't hold us up. As it relates to the question about the manuscript, the manuscript's written.

Yes.

Got what we need we can put it together, we're going to submit it so from that standpoint.

It won't hold us out.

As it relates to the question about the managed care managed scripts written.

Mitchell Steiner: It's done, okay, and so I think that's record time as well, and so it's in the process of being, And our job is to sit and wait for the peer review process, and that's a little harder to tell. But my guess is it will be an online publication initially, so it gets out as quickly as possible. And the idea would be, hopefully, that it's coordinated in such a way that the manuscript and the EUA authorization happen around the same time, so that you guys can see the information, and we're on track for that.

It's done.

And so I think thats record time, as well and so it's in the positive being.

He reviewed reviewed and our job is to sit and wait for the peer review process and Thats, a little harder to tell but my guess is it will be an online and online.

Publication initially so it gets out as quickly as possible.

And the idea would be hopefully that it's coordinated in such a way that the manuscript and the EUA authorization.

At around the same time.

So that you guys can see the see the see the information.

<unk> and.

We're on track for that.

Mitchell Steiner: And just to follow up, you know, as you see an eventual NDA possibility for sibizibulin in COVID-19, wanted to ask, you know, given the performance of the drug in the phase three population, perhaps there could be similar benefits to non-COVID patients with ARDS. I wonder if this has encouraged you to look into any further clinical developments in, you know, non-COVID-19 ARDS type of conditions. As I mentioned in my prepared remarks, absolutely, I mean, when I went back and reviewed the literature, I was shocked to see that ARDS remains an incredibly important critical care problem and that viral-induced ARDS is incredibly common. Influenza A and RSV are the two big ones that come to mind.

Great and just a follow up.

You see an eventual NDA.

Possibility for some visibility on COVID-19 wanted to ask given the performance of the drug in the phase III population, perhaps there could be similar benefits to non COVID-19 patients with Ards wondering if this is encourage you to look into any further clinical development in <unk>.

Non COVID-19 or type of condition.

Conditions.

So as I mentioned in my prepared remarks.

Absolutely.

When I went back and reviewed the literature I was shocked to see that <unk> remains an incredibly important critical care problem and that to viral induced args's incredibly common.

Influenza, a and RSV are the two big ones that come to mind influenza, a which we all can relate to <unk>.

Mitchell Steiner: Influenza A, which we can all relate to, we've accepted the endemic, which is roughly 52,000 deaths and about, you know, several hundred thousand hospitalizations a year. And you have to get a new shot, a new booster shot, a new flu shot every year. So that's the model that COVID ends up hitting. And, you know, from an endemic standpoint, that's a huge market for an endemic disease. And by the way, the Influenza A virus follows the same life cycle, if you will, as COVID-19, meaning that it goes through, it binds to the outside of the cell, it uses microtubules to go into the cell, it uses microtubules to take the new viruses and get them out of the cell. And then, of course, the cytokine storm is what it triggers to cause ARDS. Very similar pathogenesis and pathophysiology as COVID-19.

We have accepted to the endemic which is roughly 52000 deaths and about you know.

Ah you know several of our several hundred thousand hospitalizations, a year and you have to get a new shot new booster shot a new flu shot every year. So that that's the model that COVID-19 ends up hitting in.

From an endemic standpoint, that's a huge market for an endemic disease and and if we.

And if we and by the way influenza a virus.

Follows the same lifecycle, if you will as COVID-19, meaning that it goes through.

It binds to the outside the cell uses microtubule to go into the cell uses microtubules too.

The new viruses and get it out of the cell and then of course, the cytokine storm is what it triggers to cause <unk> very similar.

Mitchell Steiner: And so, yes, we've already started writing the protocols for the clinical development. So that will be the first one we roll out because it's such an obvious one. And we have something that's different than what's out there.

Part of it is Paso Genesis pathophysiology as COVID-19, and so yes, we've already started writing the protocols for the clinical development.

That will be the first one we rolled out because it's so so it's such an obvious one and we have something thats different than whats out there. So again as you can imagine the situation, where we will allow standard of care.

Mitchell Steiner: So again, you can imagine a situation where we roll out the standard of care. And that would really greatly expand our patient population. And then second, RSV is the other area; when I gave the numbers in the presentation, it was for RSV not in children; it was RSV in those greater than 65-year-olds.

Supportive care versus core versus <unk>, plus supportive care and that would really greatly expand our patient population and and then second.

RSV is the other area.

When I gave the numbers in the presentation. It was for RSV not in children that was RSV in the greater than 65 year olds, and but we have to think about children as well as the potential population and in fact, we've been asked to supply a protocol to move this into children by FDA and so.

Mitchell Steiner: But we have to think about children as well as a potential population, and in fact, we've been asked to supply a protocol to move this into children by FDA. And so we're going to be clearly responsible and diligent in doing that. But ARDS is an interesting group to go into.

So you know so we're going to be clearly responsible and diligent in doing that and but you know args's an interesting an interesting group to go into also because of the anti inflammatory activities.

Mitchell Steiner: Also, because of its anti-inflammatory activities, we're getting interest in going after the more aggressive inflammatory diseases, which something with this kind of anti-inflammatory slash side effect profile could be useful. So stay tuned. I think there's a lot of room for sibizibulin being an oral agent with this kind of side effect profile to play a role in virally induced ARDS and potentially some inflammatory diseases.

We're getting interest in going after the more aggressive inflammatory diseases, where something with this kind of.

Anti inflammatory slash.

Well the side effect profile could be useful so stay tuned I think theres a lot of room for <unk> being an oral agent with this kind of side effect profile to play a role in a virally virally induced <unk> and potentially some of the anti inflammatory these some of the inflammatory diseases diseases.

Great. Thank you.

Thank you.

Leland Gershell: Thank you. Thank you. The next question comes from Yi Chen with H.D. Wainwright.

The next question comes from Louise Chen with H C. Wainwright. Please go ahead.

Yi Chen: Please go ahead. Thank you for taking my questions. My first question is, once you obtain the EUA for subsidiary loan in the U.S., how easy would it be to obtain similar authorizations in other countries and territories?

Thank you for taking my questions. My first question is once you obtain the EU.

For sufficient bureau in the U S O easy would it be to obtain similar authorizations in other countries and territories.

Mitchell Steiner: Great question. So if you look at Pfizer, and again, I'm just getting this in the news, so I don't know any secrets, but they have something like 60 EUAs that have been granted. And so usually, what happens is that the two big regulatory agencies that the world looks to to do the work in lieu of what they would do in their own regulatory agencies are U.S. regulatory agencies. And so that's kind of what's going on.

Great question so.

You look at Pfizer and again I'm just getting this in the news so I don't know any secrets, but they have something like 60 <unk>.

They have been granted okay, and so usually what happens what happens is that the two the two big.

Regulatory agencies at the World looks to do the work and look what they would do.

Our own regulatory.

Regulatory agencies in the U S and EU.

Mitchell Steiner: And so that's kind of what's going on, and specifically the EMA. So if we get U.S. approval, then about 80 Senate countries will follow that lead and also very quickly expedite approval in their countries. And if you get to the EU, roughly 80% of the countries will do the same, but they may not be the same 80%. And so the goal would be, and our strategy is the US, and now we're starting in the EU.

Specifically the EMA.

We get U S approval, they're in about 80 countries will follow that lead and also very quickly expediting approval in their country.

And if you get if you get the EU.

<unk> said that roughly 80% of the countries will do the same but they may not be the same 80%.

And so the goal would be and this is an art strategy is U S. And now we are starting in EU and the NHRA because of Brexit Brexit in Great Britain to big market, we've already started that process.

Mitchell Steiner: And the MHRA, because of Brexit and because Britain's a big market, we've already started that process. We're working in Brazil and the neighboring countries that follow the treaty, so South America, and we're looking into South Africa now because that's the hardest-hit country and also the country that has the most resources to direct this kind of therapy to its people.

We're working in Brazil in the neighboring countries that.

The treaty.

So South America, and looking into South Africa, now because thats the most.

<unk> had country and also the country that has the most resources to direct this kind of therapy to their folks.

Mitchell Steiner: And then furthermore, and again, each of those has regulatory issues, but again, US regulatory will go a long way. So we think that if we can get US regulatory approval, we believe that once we have US regulatory approval and we're starting the process to get the other countries at least the information into their system, we should see a series of EUAs after we get the formal EUA authorization from the US. Thank you. And my follow-up question is... Recent news reports show that patients who received Pfizer's new COVID drug, Paxilovir, in the outpatient setting had symptoms rebound after the treatment, potentially showing that Paxilovir is not such an effective drug.

<unk>.

And then Furthermore.

Each of those have regulatory but again U S regulatory would go a long way. So we think that if we can get us Brexit we believe that once we have U S regulatory and we are starting the process to get the other countries at least the information into their system that we should we should see a series of <unk>.

After the after we get the formal EUA authorization from.

U S.

Thank you and my follow up question news.

Recent news report showed that patients who.

Who received fibers.

Kobe drug <unk>.

Sorry.

Symptoms rebound.

<unk> for the treatment.

Yi Chen: So with that, do you have any plans to use your drug to treat patients in the outpatient setting? Yeah, the answer is yes. We believe Subizubulin could have activity in the pre-hospital setting, so the general population. The reason we went into the hospitalized setting is that the FDA told us. So the FDA said that your clinical benefit-risk ratio would be best in patients that are dying in the ICU and dying in hospitals. If you can show something there, then that would be great.

Potentially showing the kind of slow but it is not such a effective drug. So is that do you have any plans to.

Yes.

Use your drug to capture the patients.

Tissue facility.

Yeah. The answer is yes, we believe so busy beulah and could have activity in the pre hospital.

Hospital.

Setting so the general population. The reason we went into the hospitalized setting as the FDA told us too. So the FDA said that your clinical benefit risk ratio will be best in patients that are dying in the ICU and dying in the hospitals have you could show something there then that.

Mitchell Steiner: And, of course, a lot of drugs have tried to do that, and a lot of drugs have failed, or they showed something less than a 5% mortality benefit. And this is the first one that shows a 25% absolute reduction and a 55.2% relative reduction in deaths. But because the mechanism is antiviral and anti-inflammatory, we do believe that we can go earlier. And it's something to think about in the future. But you raise a good point, and that is that we're still trying to understand what's called the rebound phenomenon.

That would be great and of course, a lot of drugs tried to do that in a lot of drugs.

Or they showed something less than a 5% mortality benefit and this is the first one that shows a 25%.

25% absolute reduction and 55, 2% relative reduction in deaths, so, but because of the mechanisms antiviral anti inflammatory.

We do believe that we can go earlier.

Sure.

And it's something to think about in the future, but you raise a good point and that is we're still trying to understand.

Called the rebound phenomenon. So it kind of makes sense, if youre, giving some somebody an antiviral and you stop the antibody not curing their patients and we stopped the antiviral then the cells that have the virus and we will start growing again, and so rebound may happen and were seeing that and so there is going to be room, even in the.

Mitchell Steiner: So it kind of makes sense. If you're giving somebody an antiviral and you stop the antiviral, you're not curing that patient. And if you stop the antiviral, then the cells that have the virus in them will start growing again. And so rebound may happen, and we're seeing that.

Mitchell Steiner: And so there is going to be room, even in the pre-hospital general population, to augment the vaccines. And now with the BA4 and BA5 variant coming out of South Africa, again, we always hear this. They always try to scare you to think it's going to circumvent the vaccine, and it may. This one looks like it might.

Pre hospital general population.

To augment.

The vaccines and <unk> and now with the VA for <unk>.

Five variants coming out of the South Africa again, we always hear that they always tried to scary to think its going to circumvent that vaccine in EMEA. This one it looks like it may.

Mitchell Steiner: But, you know, the vaccine isn't the final answer because people can still pass it, people can still get it. And so it's not uncommon to get COVID-19 and hopefully be less severe. But for the immunocompromised and for patients with, you know, severe, major comorbidities, it's still becoming, it's still a big problem. So yeah, so we could potentially go earlier.

But it's still the vaccine isn't the final answer because people could still pass if people can still get it and so it's not uncommon to get COVID-19, and hopefully be.

Less severe immuno compromise and for patients with severe <unk>.

May.

Major comorbid Comorbidities, it's still becoming a big problem.

Yeah, So we could potentially go earlier.

Got it. Thank you. Thank you.

Yi Chen: Thank you. Again, if you would like to ask a question, please press star and 1. To withdraw your question, please press star and 2. The next question comes from Kumar Raja with Brookline Capital Markets. Please go ahead. Thanks for taking my questions and also congratulations.

Again, if he would like to ask a question. Please press Star then one to withdraw your question. Please press star two.

The next question comes from Kumar, Russia, with Brookline capital markets. Please go ahead.

Thanks for taking my questions and also congratulations.

Kumar Raja: So, looks like you need to follow the patients for safety once you have the EUA. What are your expectations in terms of, you know, how many patients or how long they have to be followed for safety data with regard to the potential NDF filing? So I'm going to ask Dr. Gary Barnett, our Chief Scientific Officer at Hanell's Regulatory, to answer that question, so this way, you'll understand the process under the EUA.

So it looks like you need to follow the patients for therapy. Once you have the EUA.

What are your expectation in terms of like how many patients and for how long they have to be followed for the safety data with regard to the port.

India filing.

So I'm going to ask Dr. Gary Barnett, our Chief Scientific officer, and handles regulatory to answer that question. So this way you will see with the process under the EUA.

Gary Barnett: So under the EUAs, you are obligated to collect what they call spontaneous reporting of adverse events, and we believe that that is exactly what we should do. We do that for NDA approved drugs as well. And, you know, with what's called a MedWatch form, and it's very formal, and they submit these things to the FDA, and they submit these adverse events and serious adverse events to the sponsor. Spontaneous reporting in a fully NDA-approved product is sparse. I mean, a lot of times, physicians don't comply with that requirement. But under an EUA, they follow it pretty well.

Yes.

Under the EUA.

You are obligated to collect what they call spontaneous.

Reporting of adverse events and we believe that that is exactly we'll just follow the normal EUA process.

We do that for NDA approved drugs as well.

Uh huh.

What's called a medwatch form and it's very formula and they submit these things through the FDA and they submit these adverse events and serious adverse events with the sponsor.

Training is reporting.

Full NDA approved product is sparse I mean, a lot of times the physicians don't don't comply with that requirement.

Under new UAS, they follow it pretty well and then we will course encourage our investigators are.

Gary Barnett: And then we will, of course, encourage our investigators or PIs to do these things. And so that's what we're planning. We're planning on collecting the standard EUA safety requirements, which is spontaneous reporting of serious adverse events during the EUA process. But let me also remind you that this program isn't just about the COVID-19 program. We do have a history with sibizibulin in our oncology program. So in prostate cancer, between the 80 patients in phase 1B2 and then in phase 3, I think we were able to count something like 250 patients that have been exposed to 9 milligrams or higher. And in some cases, particularly in cancer products, they're getting 32 milligrams a day for three years.

Two follow these things.

And so that's what we're planning we're planning on collecting the standard EUA safety requirements, which is spontaneous reporting of serious adverse events.

During the EUA process and let me just also remind you that we're very this.

This program isn't just about the COVID-19 program, we do have a history with <unk> and oncology program. So in prostate cancer between.

Between the 80 patients in the.

Phase <unk>, two and then in the phase and then the phase III.

I think we were able to count something like 250 patients that have been exposed to nine milligrams or higher and in some cases, particularly in the cancer products are getting 32 milligrams a day for three years. So this drug is well tolerated and so you add that plus the data from the phase.

Mitchell Steiner: So you know, this drug is well tolerated. And so do you add that plus the data from phase two and phase three COVID-19? And we have 199 patients in the phase three toll data set that we have safety data on. And then now you add in after the UA during the EUA period, you know, that will take place, you know, that all that is sufficient. And, as I said in my comments, we were told that no additional safety clinical trials would be required.

<unk> two in phase III, COVID-19, and we have 199 patients in the phase III.

Total data set that we have safety data on and.

Now you add in <unk>.

After the UA during the EUA periods Youre right into all of the spontaneous reporting that will that will take place.

<unk>.

You know that all of that is sufficient and as I said in my comments, we were told that no additional safety clinical trials will be required.

Kumar Raja: That's great. And in terms of the negotiations regarding stockpiles, how is that going to work as the EUA is, you know, kind of moving through the channels? Well, the good news is we have been incredibly active with government. We started, as you can remember from our comments from phase two, we started discussions with BARDA. We have made some good friends with BARDA.

Okay, that's great.

And in terms of the negotiations regarding stock piling, how is that going to war.

Hum.

<unk> kind of moved through the time.

Well the good news is we have been incredibly active with government.

We started as you can remember from our comments from the phase two we have started discussions with BARDA. We have made some good friends with BARDA. So we've talked to BARDA on a regular basis as you know they have a tech watch group how many people involved the tech watch and it's like how many agencies.

Mitchell Steiner: So we, you know, we talk to BARDA on a regular basis. As you know, they have a tech watch group. How many people are involved with tech watch? And it's like, how many agencies? Oh, it's, you know, 15, 20 agencies. Yeah, 15 to 20 agencies that are part of the tech watch that we've presented. And so, and then furthermore, our company has hired several lobby groups to also help us navigate through the government.

<unk> 2015.

15 to 20 agencies that are part of the Tech watch it.

Presented in the air.

Formation, and and so and then the Furthermore, our company has.

<unk> hired.

Several lobby groups to also help us navigate through a government and.

Mitchell Steiner: And so what we're hearing loud and clear is, you know, don't look at, you know, what's happening in Congress with the $10 billion. I mean, $33 billion will be earmarked next year. I mean, you can see the reason the Republicans have added Democrats because the states have tons of money that's just sitting there that was allocated for COVID. And they wanted to spend some of their money.

So what we're hearing loud and clear is don't look don't look at what's happening in Congress with the $10 billion $33 billion will be earmarked next year. I mean, you can see the reason that Republicans have added Democrats and because the states have tons of money that just sitting on that was allocated for COVID-19 and they.

Mitchell Steiner: And then there are other budgets where they're allowed to go 5%. 5% of the budget and move it to something that wasn't originally earmarked. So what we're hearing is a drug like this, which is a therapeutic that reduces deaths at the last opportunity you have to grab a patient. I mean, and again, let me dream for a moment.

Wanted to spend some of their money and then there are other budgets that are allowed to go 5%.

5% of the budget and move it to something that wasn't originally earmarked. So what we're hearing is a drug like this.

Which which is a therapeutic that reduces deaths in the last opportunity you have to grab a patient I mean and again, let me dream for a moment, if we reach a million deaths. This year I mean.

Mitchell Steiner: If we reach a million deaths this year, I mean, a million deaths this year from the two and a half years of the pandemic is a terrible milestone. But if our drug had been available at the beginning of the pandemic, that means 550,000 people could be home. I mean, that's like half the population of San Francisco or Seattle.

Desk this year from the two and a half years of the pandemic, it's a terrible milestone, but if our drug was available at the beginning of the pandemic that means 550000 people could be home right now.

I mean, that's like four.

That's like half the population in San Francisco, So Seattle.

Mitchell Steiner: So the discussions we're hearing are, guys, get your EUA. Once the EUA is authorized, then it will trigger a series of events that will give the government cover to move politically towards the money. Okay, great. Thanks so much. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks. Thank you. Thank you, operator. I appreciate you all joining us today on today's call. I look forward to updating you all on the progress on our next investors call. We're very, very excited about our progress with COVID-19, and we look forward to continuing to update you specifically on Subizubulin.

So so so the discussions we're hearing is guys gets you EUA once the EUA is authorized then it will trigger a series of events that will give government cover to move politically towards.

The money.

Okay, great. Thanks, so much.

Ladies and gentlemen, this concludes our question and answer session I would like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks.

Thank you. Thank you operator I appreciate you all joining us today on today's call I look forward to updating you all on our progress in our next investors call.

Very very excited about our progress with COVID-19, and we look forward to continuing to update you specifically on <unk>. Thank you.

Mitchell Steiner: Thank you. The digital replay of this conference call will be available beginning approximately noon Eastern Time today, May 12th, by dialing 1-877-344-7529 in the U.S. and one, four, one, two, three, one, seven, zero, zero, eight, eight, internationally. You will be prompted to enter the replay access code, which will be 821-5063. Please record your name and company when joining. The conference has now concluded.

The digital replay of this conference call will be available beginning approximately noon eastern time today may 12.

187734475 to nine in the U S.

And one for 12317.

Eight eight internationally.

You'll be prompted to enter the replay access code, which will be 8215063. Please.

Please record your name and company when joining.

The conference has now concluded thank you for attending today's discussion.

Okay.

[music].

Yeah.