Q3 2020 Veru Inc Earnings Call

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Good morning, ladies and gentlemen, welcome to Rose Inc. Investor Conference call. All participants will be in listen only mode should you need assistance well they signal the conference specialist by pressing the Starkey followed by zero.

Operator: Good morning, ladies and gentlemen. Welcome to Veru's Inc. Investor Conference Call. All participants will be in listen-only mode.

Operator: Should you need assistance, please signal the conference specialist by pressing the star key followed by zero. After today'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's Inc. Director of Investor Relations.

After todays discussion they'll 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 fish for <unk> director of Investor Relations go ahead.

Good morning.

Samuel Fisch: Good morning. The statements made in this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company's current assessment of the risks and uncertainties related to our business. Our actual results and future developments could differ materially from the results or developments expressed or implied in such forward-looking statements. Factors that may cause actual results of development to differ materially include such things as the risks related to the development of the company's product portfolio, risks related to the ability of the company to obtain sufficient financing on acceptable terms when needed to fund development and company operations, risks related to competition, government contracting risks, and other risks detailed in the company's press releases, shareholder communications, and securities exchange commission files.

Statements made in this conference call that are not historical in nature.

Looking statements.

Such forward looking statements reflect the company's current assessment of the risk uncertainties related to our businesses.

Our actual results and future developments could differ materially from the results are developments in such forward looking thing.

Factors that may cause actual results or development to differ materially include such things as the risks related to the development of the company's product portfolio risk related to the ability of the company to pay insufficient financing.

On acceptable terms, we need to fund development company operations.

Risks related to competition.

Government contracting risks.

The risks detailed in the company's press releases shareholder Communications Securities.

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Additional information regarding such risks the company urges you to view, it's 10-Q and 10-K S. You see filings I'd now like to turn the conference over the Doctor Mitchell Steiner bearings, Chairman CEO and president.

Samuel Fisch: For additional information regarding such risks, the company urges you to view its 10Q and 10K SEC filings. I'd now like to turn the conference over to Dr. Mitchell Steiner, Barrow-Rankin's Chairman, CEO, and President. Thank you, Sam, and good morning.

Thank you Sam and good morning.

This morning's call Michele Greco CFO and T O failed Greenberg executive Vice President legal and Sam Fish <unk> director of Investor Relations. Thank you for joining our call various it oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management.

Mitchell S. Steiner: With me on this morning's call are Michele Greco, CFO and CAO, Phil Greenberg, Executive Vice President of Legal, and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Before I provide an update on the clinical development of our drug pipeline and the commercialization of our products, as well as provide financial highlights for the third quarter of fiscal year 2020. It is important to reflect on the great progress we have made transforming our company into an oncology biopharmaceutical company that's supported in part by a growing revenue cash-generating sexual health business. Not only are we planning for 2021 two phase three registration trials, one for Bureau 111, our novel oral tubulin targeting agent to treat metastatic castrate-resistant prostate cancer, and the other for Veru 100, our three-month GnRH antagonist long-acting depot to treat hormone-sensitive advanced prostate cancer.

Prostate cancer before I provide the update on the clinical development of our drug pipeline and the commercialization of our products as well as provide financial highlights with third quarter fiscal your twentytwenty.

It is important to reflect on the great progress we have made transforming our company into an oncology biopharmaceutical company. That's it that's supported in part by a growing revenue cash generating sexual health business.

Not only are we planning for 24 2021, two phase three registration trials, one did Bureau 111.

Our novel oral Tubulin targeting agent to treat metastatic castrate resistant prostate cancer and the other severe or 100, our three month did you get an hour h. antagonist long acting depot, they treat hormone sensitive advanced prostate cancer, but also we expect to continue to grow our base sexual health bid.

Mitchell S. Steiner: But also, we expect to continue to grow our base sexual health business. In fact, we have had ten quarters of continued significant growth for FC2 and pre-boost, known by the brand name Roman Swipes, and we plan to submit an NDA for Tadfin, the combination of Tadalifil and Finasteride for BPH late this year, to continue the prospects for even more revenue. The model is working, the transformation is near complete, and now let's focus on the significant progress we have made in the advancement of our drug pipeline. Veru111 is a novel oral, first-in-class tubulin targeting agent that cross-links and disrupts alpha and beta tubulin subunits of microtubules.

In fact, we have had 10 quarters of continued significant growth actually two and pre boost known by the brand name Roman swipes and we plan to submit an Andy you gave a tad fend the combination of to Dallas Finasteride BPH late this year to continue the prospects, but even more revenue.

Model is working the transformation is near complete.

Now, let's focus on the significant progress we have made on the advancement of our drug pipeline.

[noise] Veer 111 is a novel oral first in class Tubulin targeting agent that crosslink send the swaps alpha and beta to be like SAP units microtubules.

You are 111 is in its clinical development to treat metastatic castration and novel androgen receptor targeting agent, which is enzalutamide apparatus resistant prostate cancer. The prior to Ivy chemotherapy, a growing unmet medical need and advanced prostate cancer the phase.

Mitchell S. Steiner: Veru111 is in its clinical development to treat metastatic castration and novel androgen receptor targeting agents, which is enzalutamide or abiraterone, resistant prostate cancer but prior to IV chemotherapy, a growing unmet medical need in advanced prostate cancer. The Phase 1b clinical study enrolled 39 subjects from 7 clinical sites in the United States. A standard 3 by 3 design was used to establish the maximum tolerated dose to select a recommended clinical dose for the Phase 2 study and to assess preliminary evidence of anti-tumor activity. The maximum tolerated dose of Veru 111 was determined to be 72 mg as 3 of 11 of these men had reversible grade 3 diarrhea. No grade 3 diarrhea was observed at doses of 63 mg or less per day.

Phase one be clinical study enrolled 39 subjects seven clinical sites in the United States a standard three bite redesign was used to establish the maximum tolerated dose to select a recommended clinical dose of phase two study and to assess preliminary evidence of anti tumor activity.

The maximum tolerated dose severe weather was determined to be 72 milligrams.

Three of 11 of these men had reversible grade three diarrhea, no grade three diarrhea was observed the doses of 63 milligrams or less per day.

Doses of your one weapon of 663 milligrams, a lower per day. The most common adverse events were mild to moderate nausea, vomiting, diarrhea fatigue. There were no reports of neurotoxicity and no neutropenia observed at 63 milligrams and lower but the continuous oral 21 day daily dose.

Mitchell S. Steiner: At doses of Veru111 of 63 mg or lower per day, the most common adverse events were mild to moderate nausea, vomiting, diarrhea, and fatigue. There were no reports of neurotoxicity, and no neutropenia was observed at 63 mg or lower for the continuous oral 21-day daily dosing cycle. We have seen evidence of anti-tumor efficacy with PSA declines in objective tumor responses. Ten men, or 25% of the study subjects, received at least four 21-day cycles of oral Veru-111. The study is ongoing as subjects are still on study without tumor progression. The median duration of treatment without progression so far is 10.5 months with a range of 5.5 to 16 months. To better understand the clinical relevance of these preliminary findings, it is important to note that all patients with metastatic castrate-resistant prostate cancer at the time of enrollment into the Phase 1b trial had evidence of disease progression with at least one of the novel androgen receptor-targeted agents, either abiraterone or enzalutamide.

Cycle.

We have seen evidence of anti tumor efficacy with P.S.A. declines in objective tumor responses 10 men with 25% of the study subjects received at least for 21 day cycles of Oral Bureau, 111 studies ongoing aseptic. So still on study without tumor progression the median during.

Ration of treatment without progression so far is 10 point.

10.5 months with a range of 5.5 to 16 much to better understand the clinical relevance of these preliminary findings is important to note that all patients with metastatic castrate resistant prostate cancer at the time enrollment into the phase one be had evidence of disease progression.

With at least one of the novel androgen receptor targeting agency the apparatus on Enzalutamide back 44% of the subjects in a phase one be at failed, both and solidified and apparatus.

Mitchell S. Steiner: In fact, 44% of the subjects in the Phase 1b had failed both enzalutamide and abiraterone. Recently, in the scientific literature, for this similar population of men, the median observed time to cancer progression while being treated with an alternative androgen blocking targeting agent was approximately 3.6 months, and even less, like 2.5 months for men that have failed both the androgen receptor targeting agents, abiraterone, and en

In contemporary studies recently reported in the scientific literature for this similar population of man. The median observed time to cancer progression well being treated with an alternative antigen blocking targeting aging agent was approximately 3.6 months and even less like 2.5 months the men.

To have failed both the androgen receptor targeting agents apparatus and enzalutamide.

We're also near completion in the enrollment up our approximately 40 men in the open label Phase two portion of the clinical trial in 14 U.S. centers. The patient population the patient population, but this portion of the trial is men with metastatic castration novel entry blocking age of resistant.

Mitchell S. Steiner: We're also near completion in the enrollment of approximately 40 men in the open-label Phase II portion of the clinical trial in 14 U.S. centers. The patient population for this portion of the trial is men with metastatic castration, novel entry-embarking agent-resistant prostate cancer, and prior to any IV chemotherapy. And we're using the recommended dose and schedule selected from the Phase Ib, which is a 63. Like the Phase 1b, we have already observed significant PSA declines in the Phase 2 clinical study. We have the clinical, safety, and anti-tumor efficacy data necessary from the Phase 1b clinical study to move forward to select the patient population, VIRA-111 dose, and schedule for the Phase 3 registration trial. By late fall, we will have additional clinical data on 63 mg oral daily for 21 continuous days per cycle in almost all of the Phase 2 subjects.

Stay cancer and prior to any Ivy chemotherapy, and we're using the recommended dose and schedule select isn't the phase one be which is 63 milligram oral daily dosing for continuous 21 days per cycle.

Like to phase one be we have already observed significant P.S.A. declines in the phase two clinical study.

We have the clinical safety and anti tumor efficacy data necessary from the phase one be clinical study to move forward to select the patient population Veer 111 dose and schedule for the phase three registration trial by late fall, we will have additional clinical data under 63 milligram.

Oral daily for 21 continuous days per cycle and almost all of the phase two subjects.

Recently, we have received positive F.D.A. input agreement and regulatory clarity for our proposed phase three registration trial program.

Mitchell S. Steiner: Recently, we have received positive FDA input, agreement, and regulatory clarity for our proposed Phase III registration trial program. The Phase III trial is designed to be an open-label, single-pivotal, randomized clinical study to evaluate the efficacy and safety of Vero111 versus an alternative androgen receptor targeting agent in men with metastatic castration-resistant prostate cancer who have developed cancer progression while receiving one androgen receptor targeting agent. The primary endpoint will be radiographic progression-free survival. By having radiographic progression-free survival as the primary endpoint, the sample size of the Phase III study could potentially be between 200 and 300 men, which is a substantially smaller size clinical study that might otherwise have been required if the primary endpoint was overall survival.

The phase three trial was designed to be an open label single pivotal randomized clinical study to evaluate the efficacy and safety. There are 111 versus an alternative androgen receptor targeting agents in men with metastatic castration resistant prostate cancer live developed cancer progression well.

Receiving one androgen receptor targeting agent the primary endpoint be radiographic progression free survival.

By having radiographic progression free survival is the primary endpoint the sample size of the phase three study could be potentially between 203 hundred man, which is substantially smaller size study clinical study that might otherwise had been required if the primary endpoint was overall survival.

We plan to submit the final phase three clinical registration study protocol to F.D.A. in the fourth quarter of calendar year 2020.

Mitchell S. Steiner: We plan to submit the final Phase III Clinical Registration Study Protocol to FDA in the fourth quarter of calendar year 2020. We anticipate starting the Global Phase III Pivotal Registration Clinical Study in the first quarter of calendar year 2021. We also plan to meet with the European Medicines Agency to obtain their input as well. This pre-chemotherapy space in men who have metastatic castration and androgen receptor targeting agent resistant prostate cancer is currently one of the fastest growing unmet medical needs segments in advanced prostate cancer. There are currently no FDA-approved drugs for this indication.

We anticipate starting the global phase three pivotal registration clinical study in the first quarter of calendar year 2021, We also plan to meet with the European Medicines agency to obtain their input as well.

It's preclinical excuse me this pre chemotherapy space and men, who have metastatic castration and androgen receptor targeting agent resistant prostate cancer is currently one of the fastest growing unmet medical need segments in advanced prostate cancer. There are currently no ft aipu drugs for this indication.

According to our Q via oral drugs, abiraterone and Enzalutamide, the advanced prostate cancer had over $6 billion.

Mitchell S. Steiner: According to Acuvia, oral drugs abiraterone and enzalutamide for advanced prostate cancer had over $6 billion in global annual sales in 2018, and $3.1 billion in the U.S. Men who have failed these novel androgen receptor-targeted agents are the same patients that Veru111 is currently targeting, which we estimate represents about a $5 billion annual global market. In summary, the objective with respect to the clinical development of Vero111 It has a unique drug mechanism of action, as it does not target the androgen receptor.

And in 2018 global annual sales and $3.1 billion in the U.S. men, who have failed. These novel androgen receptor target the agent or the same patient severe 111 is currently targeting which we estimate represents about 5 billion dollar annual global market.

In summary, the objective was with respect to the clinical development of your 111, which has a unique drugs mechanism of action as it does not target. The androgen receptor is depreciation veer 111 as the next go to drug in men, who have metastatic castrate resistant prostate cancer and who have.

Mitchell S. Steiner: It is to position Veru-111 as the next go-to drug in men who have metastatic castrate-resistant prostate cancer and who have developed prostate cancer progression while being treated with an androgen receptor targeting agent like abiraterone or enzalutamide but prior to using IV chemotherapy, and Advantage Severe 111 and oral medication, with a favorable safety profile that it can also be prescribed not only by the medical oncologist but also by The results from the Veru111 clinical program firmly position Veru as an oncology-focused biopharmaceutical company. The results from the Phase 1b2 clinical study of Veru111 have been accepted for oral presentation at the prestigious European Society for Medical Oncology (ESMO) virtual congress in 2020, to be held September 19-21. Mark Michalsky, MD, PhD, Assistant Professor of Oncology at the Johns Hopkins Sidney Kimball Comprehensive Cancer Center will be the presenter.

Developed prostate cancer progression, well being treated with an Andrew receptor targeting agents like apparatus anti dilutive, Mike, but prior to using Ivy chemotherapy.

And advantage severe 111 and oral medication.

The favorable safety profile is that it can also be potentially be spin. It could also be prescribed not only by the medical oncologists, but also the dermatologists. The results from that zero 111 clinical program firmly positions Bureau, that's an oncology focused biopharmaceutical company.

Results in the phase one be two clinical study of your 111 have been accepted for oral presentation at the prestigious European Society for medical oncology ESMO Virtual Congress in 2020 to be held September 19 to 21st.

Mark Makowsky, MD Phd assistant Professor of oncology, the Johns Hopkins City Kimball comprehensive cancer center will be the presenter.

Next I will update you on Bureau, 100, our proprietary peptide drug candidate for the treatment of hormones sensitive advanced prostate cancer and establish multibillion dollar global market.

Mitchell S. Steiner: Next, I will update you on Veru 100, our proprietary peptide drug candidate for the treatment of hormone-sensitive advanced prostate cancer, an established multi-billion dollar global market. The target product profile for Vero 100 is commercially and scientifically compelling as having a number of anticipated advantages over currently available androgen deprivation therapy. Veru100 is a long-acting gonadotropin-releasing hormone antagonist also known as a GnRH antagonist. This formulation was designed to be administered as a small-volume, subcutaneous, three-month depot injection without a loading dose.

The target product profile severe or 100 is commercially and scientific scientifically compelling as having a number of anticipated advantages over currently available androgen deprivation therapies fear or what have you. It is a long acting good navid tropin releasing hormone antagonists also known as it.

And our age antagonists. This formulation was designed to be administered as a small volume subcutaneous three month depot injection without a loading dose as a G.N. RH antagonists is intended to immediately suppressed testosterone with no testosterone surge upon initial.

Mitchell S. Steiner: As a GnRH antagonist, it is intended to immediately suppress testosterone, with no testosterone surge upon initial or repeated administration, and no testosterone micro-increases, which may adversely affect patient outcomes, a problem which potentially occurs with the approved LHRH agonist drugs like Lupron, Solidex, and Elgar. As previously mentioned, we've received agreement from FDA that the development program for Vero 100 may follow an expedited pathway. Based on this FDA input, the company plans to commence a single open-label, multi-center dose-finding phase 2 clinical trial in approximately 35 men, followed by a single open-label, multi-center phase 3 registration clinical trial in only approximately 100 men. Veru has made great progress, scaling up the GMP manufacturing of the drug product for the clinical trials of ERA 100.

Sure of repeated administration and no testosterone micro increases, which may adversely affect patient outcomes at problem, which potentially curves with the approved LH RH agonist drugs like lupron, so decks and our guard.

As previously mentioned we've received agreements some F.D.A. That's development program. If you are 100 may follow an expedited pathway based on this F.D.A. input the company plans to commence a single open label Multicenter dose finding phase two clinical trial in approximately 35 men followed by single.

Open label Multicenter phase three registration clinical trial, and only approximately 100 man.

There has made great progress and scaling up the GMP manufacturing and the drug product for the clinical trials of your 100, the company intends to submit an investigational new drug application by the end of 2020. So that we can commence the open label phase two clinical study by Q4 counter your 22.

Mitchell S. Steiner: The company intends to submit an investigational new drug application by the end of 2020 so that we can commence the open label phase two clinical study by Q4 calendar year 2020. The phase three registration study is expected to start in the second half of calendar year 2021. Androgen deprivation therapy is a $2.8 billion global market that appears to be moving towards supporting GNRH antagonists over LHRH agonists like Lupron and Lupolide and Eligard and Zoladex. However, LHRH agonists as a class have a black box warning for an increased risk of cardiovascular events including heart attacks and stroke. The GNRH antagonist class does not have the same black box warning. Recently, a randomized phase 3 study in 930 men that compared an LHRH agonist to a GNRH antagonist confirmed that the incidence of cardiovascular events was significantly low in men receiving GNRH antagonists.

20, the phase three registration study is expected to start in the second half of calendar year 2021.

Andrew didn't have a deprivation therapy is a $2.8 billion global market that appears to be moving towards supporting GE in our age antagonists over L. age RH agonist like lupus and loop Allied and Ela Guard Zola decks. The L. HRH agonist as a class had a black box warnings when increase.

The risk of cardiovascular events, including yard heart attacks in stroke, the GE and our age antagonists class does not have the same black box warning recently, a randomized phase three study and 930 men that compared and L. HRH agonists two each in our age antagonists confirm.

From that the incidence of cardiovascular events were significantly lower men, receiving GE and our age antagonist based on the study published by Dr. Neal shore and his colleagues in the New England Journal with Medicine in 2020, the incidence of it the evidence of adverse cardiovascular events was 54% lower.

Mitchell S. Steiner: Based on the study published by Dr. Neil Shore and his colleagues in the New England Journal of Medicine in 2020, the incidence of adverse cardiovascular events was 54% lower for an antagonist versus an agonist. Furthermore, in men who have a history of adverse cardiovascular events, the incidence of new adverse cardiovascular events was 80% lower with an antagonist versus an agonist.

Sure, but antagonist versus an agonists. Furthermore, in men, who have a history of adverse cardiovascular events. The incidence of new adverse cardiovascular events was 80% lower within antagonists versus an agonists. Therefore, it appears that GE and our age antagonists may become the drug of choice.

Mitchell S. Steiner: Therefore, it appears that GnRH antagonists may become the drug of choice for ADT because of their better safety profile. Currently, there are no GnRH antagonist injectable treatments commercially approved for beyond one month, making Veru 100, if approved, the only commercially available long-acting GNRH antagonist three-month default. Our next product candidate is Zuclomafine, a novel proprietary oral non-sterolelesterin receptor agonist being evaluated for treatment of hot flashes, the most common side effect in men with androgen deprivation therapy for advanced prostate cancer and a major reason why men want to stop androgen deprivation therapy.

80, if brady t. because of their better safety profile.

Currently there are no GE and our age antagonists injectable treatments commercially proof for beyond one month.

Making bureau 100, if approved the only commercially available long acting GE and our age antagonist three month depot.

Our next product candidates ZIP code mosinee novel proprietary Oro non store or less Jewish scepter agonists being evaluated treatment of hot flashes. The most common side effect demand with androgen deprivation therapy for advanced prostate cancer and a major reason why men when it may want to stop androgen deprivation therapy.

The next step.

Mitchell S. Steiner: The next step... is to have an end-of-phase-II meeting with FDA for the Zooclumbaphy program and to obtain agreement on the Phase III clinical program design that will be acceptable for approval. We will provide details of the design and the timing of this study after we have met with the FDA. Although Veru is focused on prostate cancer and oncology, due to the urgency of the current global pandemic, the fact that no effective therapies have been found, and that Veru111 has the potential to treat both the SARS-CoV-2 infection and the associated severe lung inflammation in COVID-19 patients at high risk for acute respiratory distress syndrome, the company is evaluating Veru111 18 milligrams for this COVID-19 indication. Drugs that target microtubules have broad antiviral activity by disrupting the intracellular transport of viruses such as SARS-CoV-2 along microtubules. Microtubule trafficking is critical for viruses to cause infection.

Is to have an end of phase two meeting with FDA for the two Colombia program and to obtain GRI agreement on the phase three clinical program design that will be acceptable for approval. We will provide details a design and the timing of this study after we have met with the FDA.

Although vierra is focus on prostate cancer and oncology due to the urgency with the current global pandemic. The fact that no effective therapies have been found and that Veer 111 has the potential to treat both the Sars koby to infection and the associated reactive severe long in inflammation in cobot 19 patients.

Hi risk the acute respiratory distress syndrome, the company's evaluating veer away 11, 18 milligrams for this cobot 19 Asia.

Drugs that target microtubules have broad anti viral activity by disrupting the interest cellular transported viruses such as ours koby to along the microtubules microtubule trafficking is critical for viruses to cause infection, and Furthermore, microtubule deep polarization agents that target.

Mitchell S. Steiner: And furthermore, microtubule depolymerization agents that target alpha and beta tubulin subunits of microtubules, like colchicine, have shown evidence of strong anti-inflammatory effects, including the potential to treat the cytokine relief syndrome also known as a cytokine storm induced by the SARS-CoV-2 viral infection that seems to be associated with the high COVID-19 mortality rate. In fact, we recently reported the results of an in vitro study conducted by a team of researchers at the University of Tennessee Health Science Center to determine if Veru 111 can suppress toxic shock levels of these key cytokines of the cytokine storm. The effects of Veru111 on cytokine production were assessed by stimulating isolated mouse spleen cells with an endotoxin that causes shock. This is called lipopolysaccharide; we just call it LPS.

Alpha and beta Tubulin sub units of microtubules like colchicine have had.

Evidences the strong anti inflammatory effects, including the potential to treat the cytokine release syndrome also known as the cytokine storm induced by the Sars code koby to viral infection that seems to be associated with the high cobot 19 mortality rates. In fact, we recently reported the results of an in vitro stuff.

I'd conducted by team to researchers at the University of Tennessee Health Science Center to determine if Bureau, 111 can suppressed toxic shock levels of these key cytokine of the cytokine storm.

The effect severe 111 on cytokine production was assessed by stimulating isolated mouse spleen cells within endo toxin that causes shock and this is called Black book Polysaccharides, We just called Lps the cells with stimulated with Ltvs for one hour.

Mitchell S. Steiner: The cells were stimulated with LPS for one hour and then incubated overnight with Veru 111 to mimic the clinical cytokine release situation and a clinical situation, and the cytokine levels were then analyzed at a concentration that represents blood levels of VIR-111 observed in clinically dosed patients. 0111 at 40 nanomolar significantly reduced, at a p-value less than 0.001, the production of key cytokines TNF-alpha was minus 31 percent, and IL-1-alpha was minus 123 percent. IL-1-beta was minus 97 percent, and IL-6 was minus 85 percent. And IL-8-homolog was minus 96 percent. This reduction was similar to or greater than, depending on the specific cytokine, to what was observed with dexamethasone at 10 nanomolar, which is a steroid and a known inhibitor of toxic shock cytokine production. Suppression of these key cytokines may be an effective way to prevent clinical deterioration of patients with COVID-19 to ARDS.

And then incubated overnight Revere 111 to mimic the clinical cytokine release situation.

<unk> clinical situation and the cytokine levels within analyzed.

The concentration that represents blood levels of your 111 observed and clinically dose patients virile 111 at 40 nano grant.

40, nanomolar significantly reduce it a P value less than 0.001, the production of key cytokine known to be involved with the covert 19 cytokine storm TNF TNF Alpha TNF Alpha was minus 31% Iowan Alpha it was minus 123% Iowan beta was minus.

97% I O six was minus 85% aisle eight home allowed was minus 96%.

This reduction was similar to or greater than depending on specific cytokine TD to whats been observed with decks that message zone at 10, animal which is a steroid and known inhibitor of toxic shock cytokine production.

Suppression of these key cytokine, maybe an effective way to prevent clinical deterioration of patients with cobot 19 to a rds.

Mitchell S. Steiner: Veru is currently enrolling a double-blind, randomized, one-to-one, placebo-controlled phase two clinical trial evaluating daily oral doses of Veru-111 18 mg versus placebo for 21 days in 40 hospitalized patients who have tested positive for SARS-CoV-2 virus and who are at high risk for ARDS. The primary efficacy endpoint will be the proportion of patients that are alive without respiratory failure at day 22. Secondary endpoints for this trial include the measured improvements in the WHO disease severity scale, which is an eight-point ordinal scale that compares COVID-19 disease symptoms and signs, including hospitalization to progression of pulmonary symptoms to mechanical ventilation as well as death. Based on Veru111 having antiviral activity confirmed and also confirmed in this in vitro study that Veru111 may have the ability to suppress key cytokines in COVID-19 patients, we' As an aside, this current cytokine study also further supports the use of Vero111 in prostate cancer, as cytokines IL-6, IL-1, and IL-8 appear to play key roles in the promotion of prostate cancer progression, metastasis, and drug resistance as well.

There is currently enrolling a double blind randomized one to one placebo controlled phase two clinical trial evaluating daily oral doses Aviragen 11, 80 milligrams versus placebo for 21 days in 40 hospitals hospitalized patients who tested positive for Sars koby too.

Iris and who are in high risk. They are D. S. The primary endpoint the primary efficacy endpoint will be the proportion of patients that are alive without respiratory failure at day 22 secondary endpoints with his trial cute include the measured improvements into Whx disease severity scale, which is in a point or no scale.

Which compares to cope with 19 disease symptoms and signs, including hospitalization two progression of pulmonary symptoms to mechanical ventilation as well as death based on zero 111, having anti viral activity confirmed in and also confirmed in this in a in vitro study. The Bureau, 111 may have ability to suppressed.

Keysight kind in the cobot 19 patients.

Even more hopeful that in the phase two study with covert 19 patients at high which they are yes. There are 111 will improve patient outcomes.

As an aside this current cytokine study also further supports you use severe 111 in prostate cancer as cytokine aisle six iowan in iOS eight appeared to play key roles and the promotion of prostate cancer progression metastasis and drug resistance as well the ability of your 111 soon.

Mitchell S. Steiner: The ability of Vero111 to suppress these cytokines may benefit men who have metastatic castrate-resistant prostate cancer, which is the primary indication that Vero111 is being developed for. There's really no downside to conducting this small study, especially if we can get non-dilutive funding for future clinical testing. And if VIRA-111 shows efficacy for this indication, the upside will be substantial for patients. Veru's ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs in large markets is being substantially supported by the sexual health business, which currently is comprised of two commercial sources for Revit, the FC2 female internal condom, as well as pre-boost moment wipes, which are the 4% benzocaine The company also expects a third source of revenues from Tad Finn, for which an NDA is expected to be submitted in late 2020 or early 2021.

Presti cytokine may benefit men, who have metastatic castrate resistant prostate cancer, which is the primary indication if you're 111 is being developed for.

[noise], there's really no downside to conducting this small study, especially if we can get non dilutive funding for future clinical testing and Aviragen 11 shows efficacy for this indication the upside will be substantial patients.

Veers ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs and large markets subset is being substantially supported by the sexual health business, which is which currently.

Is comprised of two commercial sources for revenue.

The FC to female internal condom as well as previous moment swine switch the four present bench again wives, who premature Jack Appalachian.

The company also expects a third source of revenues from Tad fit.

For which an anda is expected to be submitted in late 2020 or early 2021, and this will provide additional resources to support the company's clinical development programs.

Mitchell S. Steiner: And this will provide additional resources to support the company's clinical development program. As you can see from the earnings released in Q3 fiscal year 2020 and year-to-date fiscal year 2020, we continue to have significant growth in revenue from these commercial products. Although Ms. Greco will cover the detailed financial results highlights in a few moments, I would like to make a few comments.

As you can see if any earnings release in Q3 fiscal year 2020 and year to date fiscal year 2020, we continue to have significant growth in revenue from these commercial products.

Though Miss Greco will cover the detailed financial results highlights in a few moments I would like to make a few comments.

We again had the pleasure of reporting robust growth in fiscal year 2020, and expect further increases in FC to sales in both U.S. prescription sales in public sector.

Mitchell S. Steiner: We again have the pleasure of reporting robust growth in fiscal year 2020 and expect further increases in FC2 sales in both U.S. prescription sales and the public sector for the rest of the year. Focusing now on Veru's commercial segment, which is the sexual health business currently comprising FC2 and pre-boost moment swipes and drug commercialization costs, the company's net revenues increased again.

For the rest of the year.

Focusing now on various commercial segment, which is the sexual health business currently comprising of FC to them pre boozman swipes in drug commercialization costs.

The company's net revenues increased again in fiscal year to date Twentytwenty. It was $30.8 million compared to fiscal year to date 20, 2019 of the only $23.1 million, representing an increase of 33% our income from operations for this segment of the business was 70.

Mitchell S. Steiner: The fiscal year to date, 2020, was $30.8 million compared to fiscal year to date, 2019, up to only $23.1 million, representing an increase of 33%. Our income from operations for this segment of the business was $17.6 million for fiscal year to date, 2020, up from $11.4 million in fiscal year to date, 2019, an increase of 54%. In fact, to give you a sense of our growth trajectory, for all of fiscal year 2019, we sold 159,000 units of FC2 into the U.S. prescription market, while we sold just 234,000 units of FC2 in the first three quarters of fiscal year 2020. As you can see, our base commercial business is doing very well and, as a stand-alone business, would be quite valuable as we are experiencing significant growing revenue and income from operations.

$1.6 million for fiscal year to date 2020 up from $11.4 million in fiscal years to date fiscal year to date 2019, an increase of 54% in.

In fact to give you a sense of our growth trajectory for all of fiscal year 2019, We sold 159000 units of FC tuned to the U.S. prescription market. While we sold just in the first three quarters of fiscal year 2020 234000 units.

C into the U.S. prescription market.

As you can see our base commercial business is doing very well and as a standalone business would be quite valuable as we're experiencing significant growing revenue and income income from operations. You should also be noted that we do not have a salesforce and minimally spanned a marketing and selling these products.

Mitchell S. Steiner: It should also be noted that we do not have a sales force and minimally spend on marketing and selling these products. This continued revenue growth and profit and positive cash flow from the base commercial business have allowed us to substantially invest in the development of our prostate cancer clinical programs, which enhances the value of Veru for our shareholders. We intend to continue this revenue growth trajectory with not only the current growth of revenues from FC2 and Preboost but also from the revenues that we expect to generate from the commercialization of the company's proprietary Tadalafil finasteride combination capsule for the treatment of symptoms of BPH called Tadfin. We're collecting 12-month stability data on Tadfin manufacturing batches and expect to submit the NDA by the end of 2020 or early 2021

This continued revenue growth and profit and positive cash flow from based commercial business has allowed us to substantially in fast in a development of our prostate cancer clinical programs, which enhances the value of zero for share of for our shareholders.

We intend to continued we intend to continue this revenue growth trajectory with not only the current growth of revenues MFC tune previews, but also from the revenues that we expect a generation to commercialization of the company's proprietary to Dalafield finasteride combination capsule for the treatment of symptoms of BPH called Tad fan.

We're collecting 12 months stability data ONTAP in manufacturing batches and expect to submit the NDA by the end of 2020 early 2021 in the U.S., we're exploring the eventual commercial launch a tad fans, who tele medicine channels.

Mitchell S. Steiner: In the U.S., we're exploring the eventual commercial launch of Tadfin through the Telemedicine Channel. As you have seen, we have had great success with our other products using this sales channel. We expect to add substantial near-term revenues with high gross margins to the existing and growing revenues from FC2 and Freeboost Roman Swipes. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Thank you, Dr. Steiner.

As you have seen we've had great success with our other products using this sales channel. We expect has been to add substantial near term revenues with high gross margins the existing in growing revenues from F. C in free boost Wellman swipes.

I will now turn the call over to Michele Greco CFO and COO to discuss the financial highlights Michelle.

Thank you Dr. stayner that you're saying are indicated we're off to a great first three quarters of fiscal year 2020.

Michele Greco: As Dr. Steiner indicated, we are off to a great start in fiscal year 2020. Let's start with the highlights of our third quarter results for the three months ended June 30, 2020. Overall, net revenues were up 6% to $10.3 million from $9.7 million in the prior year third quarter due to the growth in our USFC2 prescription business. The company reported significant FC2 sales growth in its prescription business, with net revenues up 23% and $5.4 million from $4.4 million in the prior year third quarter. While overall FC2 unit sales declined slightly by 3% to 10.5 million units from 10.9 million units in the prior year's third quarter, we are pleased with the overall net revenue increase despite the slight decline in overall FC2 unit sales.

Let's start with the highlights of our third quarter results for the three months ended June Thirtyth 2020.

Overall net revenues were up 6% $10.3 million, a $9.7 million in the prior year third quarter due to the growth in our U.S.C. to prescription business.

The company reported significant I think two sales growth in its prescription business with net revenues up 23% to $5.4 million from $4.4 million in the prior year third quarter.

Well overall teaching unit sales declined slightly by 3% 10.5 million units from 10.9 million units in the prior year third quarter. We're pleased with the overall net revenue increased display despite the slight declines in overall FC two units sold.

Net revenues for the public health sector business was $4.3 million compared to $4.9 million and the players third quarter.

Michele Greco: Net revenues for the public health sector business were $4.3 million, compared to $4.9 million in the prior year's third quarter. Gross profit was $6.5 million, or 63% of net revenues, compared to $6.6 million, or 68% of net revenues, in the prior year's third quarter. The decrease in gross profit and gross margin is driven primarily by increased costs of sales recognized during the third quarter due to the temporary shutdown of the company's manufacturing facility in Malaysia as a result of the COVID-19 pandemic.

Gross profit was $6.5 million or 63% of net revenues compared to $6.6 million.

68% of net revenues in the prior years third quarter.

The decrease in gross profit gross margin is driven primarily by increased cost of sales recognized during the third quarter due to the temporary shut down at the company's manufacturing facility in Malaysia.

Both of the Cobot 19 pandemic.

Additionally, we had seen an increase in labor and equipment maintenance costs as we have ramped up production to meet demand.

Michele Greco: Additionally, we have seen an increase in labor and equipment maintenance costs as we have ramped up production to meet demand. We are pleased to report that our FC2 Malaysian manufacturing facility is back up and running with volumes consistent with volumes prior to the COVID-19 pandemic Malaysian government ordered shutdown. These financial results for the third quarter reflect shipments of 3.6 million units under new tender orders from South Africa. We previously announced that we won 75% of the South African tender, representing up to 120 million units over three years for the total tender.

We are pleased to report that our assay to Malaysian manufacturing facilities back up and running with volumes consistent with volumes prior to covert 19 pandemic Malaysian government ordered shutdown you.

These financial results for the third quarter reflect shipments of 3.6 million units under the new tender orders from South Africa.

We previously announced at the 175% of the South Africa contender representing up to 120 million units over three years for the total tender.

This translates to approximately 30 million per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over three years.

Michele Greco: This translates to approximately 30 million units per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over three years. We started shipping these orders from South Africa during the third quarter of fiscal year 2019, and today, we have shipped 10,080,000 units. We continue shipping South Africa orders during the current fiscal fourth quarter. Operating expenses for the quarter decreased by $501,000 to $7.9 million compared to the prior year third quarter of $8.4 million, primarily due to the decrease in research and development costs, which fluctuate due to the timing of drug development activities. Additionally, the company received a potentially forgivable loan of approximately $540,000 under the Paycheck Protection Program of the CARES Act. The forgivable loan was treated like a government grant and recognized a reduction in operating expenses during the quarter.

We started shipping these orders from South Africa during the third quarter fiscal year 2019, and today that ship 10.008 million units.

We continue shipping South Africa orders during the current fiscal fourth quarter.

Operating expenses for the quarter decreased by $501000 $7.9 million compared to the party your third quarter of $8.4 million, primarily due to the decrease in research and development costs, which fluctuate due to timing of drug development activities.

Additionally, the company received a potentially forgivable loan of approximately $540000 under the paycheck protection program at the carriers.

Perfect Forgivable loan was treated like a government grants and recognizes reduction in operating expenses during the quarter.

As a result, we recorded a reduction to selling general administrative expenses of approximately $420000 and a reduction to payroll related research and development cost approximately $120000.

Michele Greco: As a result, we recorded a reduction in selling general administrative expenses of approximately $420,000 and a reduction in payroll-related research and development costs of approximately $120,000. Non-operating expenses were $1.4 million compared to $933,000 in the prior year third quarter and primarily consisted of interest expense and change in fair value for derivative liabilities related to the synthetic world she's playing in. We entered into the Synthetic Royalty Financing during March of 2018. For the quarter, we recorded a tax expense of $241,000 compared to a de minimis tax benefit in the prior year third quarter.

Non operating expenses were $1.4 million compared to $933000 in the prior year third quarter and primarily consisted of interest expense and change in fair value if the derivative liability.

Related to the synthetic royalty financing.

We entered this synthetic royalty financing during March 20 team.

For the quarter, we recorded tax expense of $241000.

Fair to it de Minimis tax benefit in the prior year third quarter.

The effective tax rate for this quarter is 8.6% and for the prior quarters basically zero Judah recording a valuation allowance against the net operating loss generated for the quarter in the U.S., which is the majority of the pre tax loss for the period.

Michele Greco: The effective tax rate for this quarter is 8.6%, and for the prior quarters, basically zero due to recording an evaluation allowance against the net operating loss generated for the quarter in the U.S., which is the majority of the pre-tax loss for the period. The bottom line result for the third quarter of fiscal 2020 was a net loss of $3 million, or $0.05 per diluted common share, compared to a net loss of $2.8 million, or $0.04 per diluted common share, in the prior year third quarter. Turning to the results for the nine-month ending June 30, 2020. For the first nine months of fiscal 2020, net revenues were up 34% to $30.8 million from $23.1 million in the prior year period. As a reminder, total net revenues for all of fiscal year 2019 were $31.8 million. Overall, SC2 unit sales totaled 27.5 million units compared to 28.1 million units in the prior year period.

The bottom line results for the third quarter fiscal 2020 was a net loss of $3 million.

Or five cents per diluted common share compared to net loss of $2.8 million a four cents per diluted common share in the prior years third quarter.

Turning to the results for the nine month ended June Thirtyth 20 Twond.

For the first nine month in fiscal 2020, net revenues were up 34% to $30.8 million from $23.1 million the prior year period.

As a reminder.

Total net revenues for all of fiscal year 2018 was $31.8 million.

Overall, two unit sales totaled 27.5 million compared to 28.1 million units in the prior year period.

Net revenue from the U.S. prescription business was up 95% to $18.4 million from $9.4 million in the prior year period. It's also worth noting that all of fiscal year 2018, U.S. subscription revenues were $14.1 million.

Michele Greco: Net revenue from the U.S. prescription business was up 95% to $18.4 million from $9.4 million in the prior year period. It's also worth noting that all of fiscal year 2019 U.S. prescription revenues were $14.1 million. Net revenue for the public health sector business was $11.2 million compared to $13 million in the prior year period. Net revenue for pre-Bruce Roman Swipes increased to $1.2 million from $623,000 in the prior year period. Gross profit was up 34% to $21.2 million from $15.8 million in the prior year period. However, gross margin was flat at 69% due to an increase in cost of sales resulting from increased labor, transportation, and equipment maintenance costs and increased costs incurred during the temporary manufacturing shutdown in Malaysia as a result of the COVID-19 pandemic, which offset the increase in the U.S. prescription business.

Net revenue for the public health sector business was $11.2 million compared to $13 million in the prior year period.

Net revenue for previous from its whites increase to $1.2 million from $623000 in the prior year period.

Gross profit was up 34% to $21.2 million from 15 point.

$8 million in the prior year period.

Gross margin was flat at 69% due to an increase in cost of sales, resulting from increased labor transportation and equipment maintenance costs and increased costs incurred during the temporary manufacturing shutdown in Malaysia as a result at the club in 18 pandemic, which offset the increase in the U.S. subscription business.

Operating expenses increased to $24.7 million compared to the prior year period of $20.8 million I really do the increase in research and development costs.

Michele Greco: Operating expenses increased to $24.7 million compared to the prior year period of $20.8 million, primarily due to an increase in research and development costs. Non-operating expenses were $3.6 million compared to $3.9 million in the prior year period, which primarily consisted of interest expense and a change in the fair values of derivative liabilities related to the synthetic royalty finance. For the nine months, we recorded a tax expense of $30,000 compared to $117,000 for the prior year period. The effective tax rate for both nine-month periods is close to 1% and is due to recording an evaluation allowance against the net operating loss generated during those nine-month periods in the US, which represents the majority of the pre-tax loss for the period.

Non operating expenses were $3.6 million compared to $3.9 million in the prior year period, which primarily consisted of interest expense and change in the fair value the derivative liabilities related to the synthetic royalty financing.

For the nine months, we recorded a tax expense at $30000 compared to $117000. The prior year period, the effective tax rate for both nine month period is close to 1% and it did a recording evaluation allowance against the net operating loss generated during those nine month period in the U.S. what's reps.

Because the majority of the pre tax loss for the period.

The company has net operating loss carry forwards for us federal tax purposes, a $42.6 million, it's $14.4 million expiring in years or 2038.

Michele Greco: The company has net operating loss carry-forwards for U.S. federal tax purposes of $42.6 million, with $14.4 million expiring in years through 2038, and 28.2 million dollars which can be carried forward indefinitely, and our UK subsidiary has net operating loss carry-forwards of 61.7 million dollars which do not expire. The bottom line results for the first nine months of fiscal 2020 were a net loss of $7.1 million, or $0.11 per diluted common share, compared to a net loss of $9 million, or $0.14 per diluted common share, in the prior period. Looking at the balance sheet, as of June 30, 2020, our cash balance was $15.4 million, and our accounts receivable balance was $4.1 million. Our net working capital was $9.5 million at June 30, 2020, compared to $2.8 million at September 30, 2019.

And $28.2 million, which can be carry forward indefinitely and our UK subsidiary has net operating loss carry forwards $61.7 million, which do not expire.

The bottom line results for the first nine months of fiscal 2020 was a net loss of $7.1 million or 11 cents per diluted common share compared to net loss of $9 million.14 per diluted common shares in the prior period.

Looking at the balance sheet as of June Thirtyth 2020, a cash balance was $15.4 million.

Accounts receivable balance was $4.1 million.

Our net working capital was $9.5 million at June Thirtyth 2020, compared to $2.8 million at September Thirtyth 2019.

During the nine month ended June Thirtyth 2020, we used cash of $1.6 million, an operation and we received net proceeds from financing activity.

Michele Greco: During the nine months ended June 30, 2020, we used cash of $1.6 million in operations, and we received net proceeds from financing activities of $10.8 million, primarily due to $13.4 million that relates to the sale of shares under the 2020 Purchase Agreement and the 2017 Purchase Agreement with Aspire Capital. Overall, we're delighted to see the continued increases in sales in the U.S. FC2 prescription business and the increasing sales in pre-boost Roman swipe to Roman Health Ventures and look forward to increasing FC2 sales in the global public health sector business in the fourth quarter. These revenue sources continue to be important sources of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into an oncology and neurology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Now I'll turn the call back to Dr. Steiner. Thank you, Michele.

$10.8 million merely due to $13.4 million that relates to the sale of shares under the 2020 purchase agreement and the 27 to purchase agreement with aspire capital.

Overall, we're delighted to see the continued increases in sales in the U.S. up due to prescription business and the increasing sales in previous Roman swipes to Roman health ventures, well look forward to increasing FC to sales in the global public health sector business in the fourth quarter.

These revenue sources continue to be important sources of funds, we used to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into an oncology in urology biopharmaceutical company with a focus on developing novel medicines for the management prostate cancer now I'll turn the call back to it.

After Steiner.

Thank you Michelle we have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we now are into our third year of growth in our fifth FC to U.S. prescription business.

Mitchell S. Steiner: We have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we are now into our third year of growth in our FC2 US prescription business. Looking forward to the rest of fiscal year 2020, we expect our revenues to continue to be strong and growing towards a record year.

Looking forward to the rest of fiscal year 2020, we expect our revenues to continue to be strong and growing towards a record year with the improving performance of the sexual health business. We believe that we'll be able to substantially invest into continues clinical development of our prostate cancer drug candidates as well as to submit the NDA and if approved commercially launched.

Mitchell S. Steiner: With the improving performance of the sexual health business, we believe that we will be able to substantially invest in the continuous clinical development of our prostate cancer drug candidates, as well as to submit the NDA and, if approved, commercially launch Tadfin, which will provide even more revenue, adding to the already growing revenue from FC2 and pre-boost Roman Swipe. We anticipate a steady flow of important positive news for Veru over the next few months to one year. For Veru-111, our oral tubulin targeting agent, we will report open-label efficacy and safety clinical results for the Phase II clinical trial for Veru-111 in patients with metastatic castration and androgen receptor targeting agent-resistant prostate cancer.

TAPFIN, which would put which will provide even more revenue adding to the already growing revenue. The F. C in pre boost woman swipes.

We anticipate a steady flow of important positive news revera over the next few months to one year.

Severe 111, our or.

Tubulin targeting agent, we will report open label efficacy and safety clinical results for the phase two clinical trials of your 111 in patients with metastatic castration and androgen receptor targeting at agent resistant prostate cancer, we plan to submit the phase three pivotal registration trial protocol and.

Calendar year, Q4, 2020 and start to phase three registration clinical trial in calendar year Q1, 2020, excuse me 2021.

Mitchell S. Steiner: We plan to submit the Phase III Pivotal Registration Trial Protocol in calendar year Q4, 2020 and start the Phase III Registration Clinical Trial in calendar year Q1, 2021. 100, our novel peptide GnRH antagonist three-month depot formulation. We will complete GMP manufacturing of the clinical supply of Veru 100, submit the IND, and initiate a Phase II clinical trial. And by the second half of calendar year 2021, we will initiate a Phase III pivotal registration clinical trial. Visikomafine, our oral estrogen receptor agonist, will have a face-to-face and a phase two meeting with FDA.

The fear or 100, our novel peptide GE and our age antagonist three month depot formulation, we will complete GMP manufacturing of clinical supply of your 100 submit the 90 and initiate a phase two clinical trial and by the second half of calendar year 2021, we will initiate a phase.

Phase three pivotal registration clinical trial.

Because your club between our oral estrogen receptor agonist, we'll have a face to face and to phase two meeting with FDA [noise].

Plan to complete the phase two clinical program Cobot 19, and subjects in high risk the Rts submit the NDA for a tad fan plan to continue to demonstrate robust growing revenues for our commercial products FC to than previous Raman Swipes, and we will also secured partnerships with some of our drug products.

Mitchell S. Steiner: We plan to complete the Phase II clinical program for COVID-19 and subjects at high risk for ARDS, and submit the NDA for Tad Finn. We plan to continue to demonstrate robust growing revenues for our commercial products, FC2 and PreBoost Roman Swipe. We will also have secured partnerships with some of our drug products. We have substantially transformed our company into an oncology biopharmaceutical company supported in part by a growing revenue, cash-generating sexual health business. The model is working.

We have substantially transformed our company into an oncology biopharmaceutical company supported in part by a growing revenue cash generating sexual health business. The model is working the transformation is near complete.

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

Operator.

Ladies and gentlemen at this time, we won't be getting a question and answer session to ask a question you May Press Star then one on your telephone keypad, if you're using no speakerphone. Please we asked us to pick up your handset before pressing the keys to ensure the best sound quality to withdraw your question.

Operator: The transformation is near complete. With that, I now will open the call to questions. Ladies and gentlemen, at this time, we will begin our question and answer session. To ask a question, you may press star, then one on your telephone keypad.

Please press Star then too.

Hi, Matt just has to one question and one follow up if you have further questions. You may reenter. The question Q again, that's star then one on your to rejoin the question Q.

Operator: If you're using a speakerphone, please, we ask that you pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star, then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Again, that's star, then 1 on your keyboard to rejoin the question queue. We will now pause momentarily to assemble our roster. Our first question is from Brandon Folkes from Cantha Fitzgerald. Go ahead. Hi Mitch and team, and thanks for taking my questions and congratulations on all the progress during the quarter. Firstly, on 1.11, when we see the phase 1b data presented in September, will there be any new data, and if so, what do you think are going to be the most pertinent parts of the data we see from that 1b, you know, given that we've seen some of it later in the year?

Well now pump pause momentarily to assemble our roster.

Our first question is from Brandon Folkes from Cantor Fitzgerald go ahead.

Hi, I'm wondering mentioned team and thanks for taking my question. Thanks, Congratulations on all of the progress during the quarter I'm personally on 111, when do we see phase one be data presented and Tim by will they be any new data and if so what do you think are gonna be the most credit tenants part of the dates are we.

C one be.

Given that we've seen some of it and later in the year and then secondly ad.

As a follow on on staying on 111, and you know I think as you spoken to pause you talked about having a very good.

Indication of what you lead the FDA wants to see from a phase three protocol and it sounds like that's been pretty concerned with the dialogue, but maybe just as the phase two progressive.

Operator: And then secondly, you know, just as a follow-on, on staying on 1.11, you know, I think as we've spoken in the past, you've talked about having a very good indication of what you believe the FDA wants to see from a phase 3 protocol and it sounds like that's been further concerned with the dialogue but maybe just as the phase 2 progresses, do you envision any amendments to the phase 3 protocol and what are some of the factors there that you're watching in the phase 2 that could still meaningfully affect the phase 3 protocol? Thank you. Good.

Envision any amendments to the phase three protocol and what are some of the fact is day that you're watching interface Qt got could still meaning characteristic that phase three particle. Thank you.

Good Okay. So really the first question is basically you're going to be presenting data at ESMO in the fall is there anything new that you're going to be presenting and the in the answer is yes, what we presented today, but just sort of you know highlights of what what what we had in the study so you'll see more details now interestingly we.

Mitchell S. Steiner: OK. So really, the first question is basically, you're going to be presenting data to ESMO in the fall. Is there anything new that you're going to be presenting? And the answer is yes. What we've presented to date were just sort of highlights of what we had in the study. And so, you'll see more details. Now interestingly, which is kind of unusual for a phase 1b2, we were selected for an oral presentation. So unlike a poster where we can just lay everything out, the oral presentation is gonna be limited, but it'll be highlighted.

It would just kind of unusual for phase one be too and we were selected for a oral presentation. So unlike a poster where we can display everything out the oral presentation is gonna be limited, but it'll be highlighted to dr. Mark Makowsky is going to go through.

Additional efficacy and additional safety data.

That has not been presented before and so I think thats going to be important to look at.

And and so as I said, you'll see some more safety and you'll see why we're excited about safety and member safety is critical for urologists is going to give the medicine over and medical oncologists and you know if it's an Ivy product. It's a no go for urology is of course, but this is oral and I think you'll you'll find it a interest.

Mitchell S. Steiner: So Dr. Mark Michalski is gonna go through additional efficacy and additional safety data that has not been presented before. And so I think that's gonna be important to look at. And so, as I said, you'll see some more safety, and you'll see why we're excited about it. And remember, safety is critical if a urologist is gonna give the medicine to a medical oncologist. And if it's an IV product, it's a no-go for urologists, of course, but this is oral, and I think you'll find it interesting.

Thing.

In it and then though I think there'll be some additional tumor pictures that you'll be able to see tumors have shrunk and so you can see further evidence of objective tumor responses.

And that's about as much as I can say without giving you more data.

As it relates to the second question, which is and we're excited about gay and that's and that's the reason we went to the FDA and that's why we accelerated our discussions with the FDA because we were able to pick a dose based on safety and efficacy and we know our patient population and so that's that's the reason why went forward to the FDA, we pick the doses to.

Mitchell S. Steiner: And then I think there'll be some additional tumor pictures where you'll be able to see tumors that have shrunk, and so you can see, you know, further evidence of objective tumor responses. And that's about as much as I can say without, you know, giving you more data. As it relates to the second question, which is, and we're excited about it, okay, and that's the reason we went to the FDA, and that's why we accelerated our discussions with the FDA, because we were able to pick a dose based on safety and efficacy, and we know our patient population, and so that's a reason why we went forward with the FDA. We picked a dose of 63 milligrams oral daily for 21 days continuously, and we have enough patients in Phase 1b to give us a very good indication of the efficacy and safety around that dose.

83 milligrams per oral daily dosing for 21 days continuously and and we have enough patients in the phase one be to give is a very good indication of the efficacy and safety around that dose.

The phase two program is just going to be further confirmation.

Of the of the safety and the efficacy around the 63 milligram dose and that's how I would view.

That study the difference between the two is you have on we're doing three plus three design and this one everybody synchronize.

Starting at the 63 and not you know having other doses and so we're going to see what happens with just 63.

Mitchell S. Steiner: The Phase II program is just going to be further confirmation of the safety and the efficacy around the 63 milligram dose, and that's how I would view that study. The difference between the two is that in the other study, we're doing a 3 plus 3 design, and this one everybody's synchronized, you know, starting at the 63 and not, you know, having other doses. And so we're going to see what happens with just 63 patients. And I can tell you at this point now, I'm not expecting anything in that study to change what we've presented to FDA, mainly because most of the stuff that we spoke to the FDA about was around clinical trial design. So, you know, radiographic progression-free survival, which was an important endpoint to get, that's not going to change, and that's going to dictate what size study we do. The patient population, well, that's not going to change because the patient population is patients who have metastatic castration-resistant prostate cancer that have progressed on at least one androgen receptor or one androgen receptor targeting agent. So that won't change.

And and I can tell you at this point now I'm not expecting anything in that study to change.

To change what we what weve presented to FDA and mainly because most of the stuff that we spoke to it to the FDA, who about was around a clinical trial design. So you know progression free radiographic progression free survival, which was an important endpoint to get that's not going to change.

Thats going to dictate what size study the patient population, that's not going to change because of patient population of patients who.

Who have metastatic castration resistant prostate cancer that had progressed on at least one androgen receptor one androgen receptor.

Targeting agents that won't change and so so really it's going to be.

And that's the reason why we as I said, that's the reason why went to the FTC sooner rather than later so the phase two if the phase one be is still going on and we got patients 60 months in 12 months and and they're going to continue you know another way to look at a year and a half to two years is what is happening with the one BP.

Mitchell S. Steiner: And so really, it's going to be-and that's the reason why we, as I said, that's the reason why I went to the FDA sooner rather than later. So the phase two-if phase 1B is still going on, and we've got patients at 16 months and 12 months, and they're going to continue, another way to look at it is a year and a half to two years. That is, potentially, what is happening with phase 1B. The same thing is going to happen with phase two. So that's the reason why we don't want to wait another two years, because you're not going to gain any additional information, you know, for patients that, you know, traditionally, if they were on one androgen blocking agent, and they failed, and they went to an alternative one, you're looking at, you know, progression-free survival of about 3.7 months. And if they had both abiraterone and azolutamide and failed, it's more like two and a half months.

Essentially the same things can happen in the phase II. So that's the reason why we don't want to wait another two years as you're not going again any additional information.

Occasions that you know traditionally if they were on a one engine blocking agents and they failed and they go to an alternative one you're looking at you know progression free survival of about 3.7 months and if they had both aberavon as really the mine failed its more like two and half minds and here. We are you know with it.

With that 25% of our patient population in a phase when be it certainly beyond that so so that's why I think what you're going to see is the phase three is gonna be final protocol will be submitted in October.

Irrespective of the phase two and a and a and this study will start at the beginning of.

The calendar year, 2021, and the phase one being a phase two against still be going on in the back background, because we're expecting patients to continue to respond to the medicine.

Mitchell S. Steiner: And here we are, you know, with 25% of our patient population in phase 1B that's certainly beyond that. So that's why I think what you're going to see is the phase three is going to be, the final protocol will be submitted in October, irrespective of phase two, and the study will start at the beginning of the calendar year 2021, and phase 1B and phase two are going to still be going on in the background because we're expecting patients to continue to respond to the medicine for, you know, a long period of time. So I'm not expecting any changes or anything of that sort.

You know a long period of time so.

So I'm not expecting any amendments or anything of that sort.

I think you know once once we get the you know once we get.

Some of the Nonclinical in some of the other stuff pulled together. That's all you know october's, where we had to put the the final protocol in and then of course will report back after the FDA has had a chance to review the final protocol to see what tweaks, we need to make.

Mitchell S. Steiner: I think, you know, once we get some of the non-clinical and some of the other stuff pulled together, that's all, you know, October is when we're going to put the final protocol in. And then, of course, we'll report back after the FDA has had a chance to review the final protocol to see what tweaks, you know, we need to make. Great. Thanks very much, Mitchell. It's very comprehensive. I look forward to seeing the data in September. And maybe just one more, I can sneak in, and I'll hop back in the queue.

Great. Thanks, very much much it's very comprehensive and of course, you seem to data in September and maybe just one more I can sneak it in all I can make here I'm sure I'm quite a bit program. If you're successful in the phase two do you think there's a chance of getting emergency use authorization for that.

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Yeah, we haven't we have that debate internally I know you know to be fully transparent we have that debate internally at some of the folks it at bureaus feel that it's possible I don't I don't I think the I don't I think we're gonna have to do more work and so I'm thinking we're going to.

Mitchell S. Steiner: On the COVID program, if you succeed in phase two, do you think there's a chance of getting emergency use authorization for that product? We have that debate internally. To be fully transparent, we have that debate internally. Some of the folks at Veru feel that it's possible.

Good non dilutive funding and we will do a phase III study and we'll see but but a lot of independent and you know what are the outcomes and how dramatic they are and if they are dramatic then your chances are that you may be able to move forward. If there if there need to be confirmed then you'll do the phase three.

Mitchell S. Steiner: I think we're going to have to do more work. So I think we're going to get non-dilutive funding and we'll do a phase 3 study, and we'll see. But a lot of it depends on what the outcomes are and how dramatic they are. If they're dramatic, then your chances are that you may be able to move forward.

So it's really hard to say.

Mitchell S. Steiner: If they need to be confirmed, then you'll do phase 3. So it's really hard to say. But I wouldn't rule out emergency use. I just think it's more likely that we'll move to phase 3. I wanted to be clear that if we do move to phase 3, that will be with non-dilutive dollars. We have to get funding support for that. My guess is given the current environment, and if our data supports going to phase three, we should be successful in getting that non-dilutive. Great, thank you very much.

But I wouldn't I wouldn't rule out emergency use.

I just think it's more likely that we'll move to a phase three I wanted to be clear that if we do move to phase three that that will be you know with non dilutive dollars.

We know we have to get funding support for that my guess is given the current environment.

If our data supports going to phase three we should be we should we should find we should be.

Successful and getting that Nondilutive money.

Great. Thank you very much.

Thank you.

Mitchell S. Steiner: Thank you. Our next question is from Leland Gershell from Oppenheimer. Go ahead. Hey, good morning, Mitch.

Our next question is from Leland Gershell from Oppenheimer go ahead.

Hey, good morning, Mitch Thanks for taking my questions on congrats on.

Leland James Gershell: Thanks for taking my questions. Congratulations on all the progress. I wanted to ask, you know, you've been having great success with the commercial business, growing revenue, obviously great margins, but you will be facing, you know, increased expenses with the Phase 3 in prostate cancer, probably one of the more expensive, if not most expensive, trials you've run to date. So I just wanted to ask in terms of how we should think about modeling, would you expect that the commercial business would be sufficient to fund bandwidth for other operations

Well the progress wants to ask you know you've been having great success with commercial business growing revenue, obviously, great margins, but you will be facing increased expenses with two phase three in prostate cancer, probably the one of the more expensive to top most expensive trials you'd want to take so just wanted to ask in terms of how we should think about modeling.

Would you expect that the commercial would would be sufficient to fund the bandwidth for other operations. How should we think about potential you know capital financing that may occur perhaps in 2021 follower.

Mitchell S. Steiner: How should we think about, you know, potential capital financing that may occur, perhaps in 2021? Yeah, so let's make some assumptions first. The first assumption is that if the commercial business continues to grow at this rate, and that we're not using any money for marketing and selling for the most part, and that all of that gross profit, and the more we make, and the fixed costs are going to take less of that, right, on a percentage basis, so every additional dollar that we get is pretty much going to drug development, and FC2 and pre-boost, I'm telling you, And so, if we're, as we reported, three quarters in, and we're at $30.8 million in revenue, and it looks like we're going to finish this year off as a record year, and next year is supposed to be another record year, how does that magnitude of money match up with what we would potentially have to spend on a phase three program? So we have two phase three programs that we're facing for next year. One is the big one, the bigger one, I should say, which is going to be between 200 and 300 patients, and from a money standpoint, that's probably in the order of about $20 to $25 million.

Yeah, So lets make some assumptions first the first assumption is that if the commercial business continues to grow at this rate and that we're not using any money for marketing and selling for the most part and ER and that a and that all of the all that gross profit and you know is you know and the more we made.

In the fixed costs are going to take less of that right, but on a percentage basis. So every additional dollar that we get is pretty much going to drug development and and an NFC to end the and pre booze I'm, telling you 2021 looks very very good so again continued growth and so.

So if we're in the order of.

As we reported in three quarters in and were at 30.8 million in revenue and it looks like we're going to finish this year off with a record year. In next year is supposed to be another record year. You know how does that magnitude of money match up with what we would potentially have to spend in a phase three program. So we.

Two phase three programs that we're facing for next year.

One is the big one big one bigger one I should say, which is going to be between 203 hundred patients ever money standpoint, that's probably probably new order of about $20 million to $25 million.

And and then we have 100 patient study, which is going to be the generates antagonists and that one is more like 100 patients and testosterone is the endpoint and all that expensive work with CP scans and all that we don't have to do that and and so that would be that study will be more in the range of about.

Mitchell S. Steiner: And then we have a 100 patient study, which is going to be the GnRH antagonist, and that one is more like, you know, the 100 patients, and testosterone is the end point, and all that expensive work with CT scans and all that, we don't have to do that. And so that would be, you know, that study would be more in the range of about, you know, $10 million or something like that, but that's not going to start until the second half of next year. So if you start looking at the money...

You know $10 million or something like that so, but that's not going to start to the second half of next year. So if you start looking into money.

Your between.

Mitchell S. Steiner: When you're between, you know, 25 to 35 million dollars in money that you need over the next 18 months, it's not a far stretch that our commercial business can help pay for a substantial amount of that. And so it puts us in a very, very good position to be opportunistic. And if people begin to realize the full value of the underlying sexual health business, which on its own clearly has more value than what we're trading at today, with that kind of cash, and it's continuing to grow in spite of COVID, that base business alone means that if anybody invests in our company, they're getting the drugs for free. And so my thinking is that we will be opportunistic as it makes sense. But if not, we are generating enough revenue and cash, coming from the sexual health business, that over 18 months, we would be able to self-fund a substantial portion of it. Okay, that's helpful.

$25 million to $35 million in money that you need over the next 18 months not far stretch that hour.

Commercial business can help pay for a substantial amount of bad.

And and so puts us in a very very good position.

To be opportunistic and if if people begin to realize the full value of the of the underlying sexual health business, which are on its own.

Clearly has more clear has more value in the were trading at today.

With that kind of catching up and you know and its continuing to grow in spite of coated.

You know that base business alone means that if anybody invest in our company, they're getting the drugs for free.

And so so you know my thinking is that we what we will be opportunistic is as it makes sense and but if not we are generating enough revenue.

And and cash.

Coming from the sexual health business that you know over 18 months.

We would be able to self fund substantial portion of it.

Okay. That's helpful. And then in that same thing given the success you've had with sexual health business I know you'll have touched fin.

Mitchell S. Steiner: And then in that same vein, given the success you've had with the sexual health business, I know you'll have Tad Finn, you know, coming down the pike, and that'll be, you know, a meaningful increment. But would you, or are you considering adding other products to the commercial business, just given how you don't need to really, you know, worry about salesforce costs and things like that? You can kind of plug into the telemedicine channel and benefit from additional revenue? How should we think about, you know, those kinds of thoughts?

Coming down the Pike and that'll be a.

A meaningful increment today, what would you or are you considering adding yet other products to the commercial business just given how you don't need to really no worry about salesforce costs and things like that on a plug into the telemedicine channel and benefit for benefit from additional revenue how should we think about you know those kinds of ports.

Yeah. So so let's take a step back we started working in telemedicine, two and a half years ago that right two and a half years something like that and reason I say that is everybody everybody is comfortable with telemedicine post Cove it.

Mitchell S. Steiner: Yeah. So let's take a step back. You know, we started working in telemedicine two and a half years ago. Is that right? Two and a half years, something like that.

Mitchell S. Steiner: And the reason I say that is, you know, everybody's comfortable with telemedicine post-COVID and because COVID has forced everybody, as a disruptor, to start looking at telemedicine as an alternative to visiting doctors. And now people are not even, you know, doctors. Not only is family not allowed to come in when the patient comes to see a doctor, but do you think they're going to let a sales rep in? So the world has changed, right?

And because covert has forced to everybody as a disruptor the start looking at Tele medicine as alternative to visiting doctors and now people are not even doctors not only is family not allowed to come in when when the patient comes to see a doctor do you think they're going to sales weapon.

So so the world has changed right and so I feel sorry food companies are launching products. In this current environment now we we chose telemedicine and the reason we did that is because it turns out that the you know the new the new the new.

Mitchell S. Steiner: And so I feel sorry for the companies that are launching products in this current environment. Now, we chose telemedicine. And the reason we did that is because it turns out that the new generation is very comfortable using their cell phones or their smartphones to order anything from, you know, bottled water they want for that evening at their home to, you know, prescription products where they don't want to wait to get the prescription. They don't want to wait to stand in line at the pharmacy. They don't want to wait for the pharmacy to get it. They just, you know, push a button, and they get it. And female contraception took the lead and was able to attract folks to their website, you know, through their marketing dollars.

Generation of very comfortable using their cell phones or their smartphones to to or anything from you know bottled water. They want that evening at home to prescription products, where they don't want to wait.

To get the prescription they don't want to wait to stand in line at the pharmacy, They don't want away for the pharmacy to get it they just push a button and they get it and and and and female contraception.

Took the took the lead and and were able to attract folks to their website.

To the market to their marketing dollars and now all of these women that were in colleges withstand home and so instead of going to the infirmary to pick up their birth control. They now have to you know they now have to find alternative sources and guess what they end up getting online in there and they're starting to move towards it telematics.

Mitchell S. Steiner: And now all of these women that were in colleges were sent home. And so instead of going to the infirmary to pick up their birth control, they now have to, you know, they now have to find alternative sources. And guess what? They end up, you know, getting online, and they're starting to move towards telemedicine platforms. And just like you, you know, the first day that you went to Amazon and bought something, you said, "boy, this is pretty cool." So you're not just going to buy that one product; you start to add other products. So the telemedicine folks are beginning to realize that they need to offer portfolio products. And so yes, I think what you're going to see in telemedicine is that they're going to continue to grow and that the model is going to change. As it relates to us, we're kind of doing that, right? We started out with the female condom business.

And.

Of platforms and just like you know you. The first day that you went to Amazon and bought something he said boy. This is pretty cool so you're not just gonna by that one product you start to add other products.

So the telemedicine folks are beginning to realize they need to offer a portfolio of products and and so yes, I think what you're going to see in tele medicine, they're going to continue to grow and that the model was going to change.

As it relates to us what kind of doing that right. We started out with the female condom business, we put that into and into Tele Medicine. Then we did pre booz put that into telemedicine and took if and literally removed. It from a sales force that was your traditional marketing and selling got rid of that salesforce, whether it was a license that we.

Mitchell S. Steiner: We put that into telemedicine. Then we did pre-boost, put that into telemedicine, and took it, literally removed it from a sales force that was your traditional marketing and selling, got rid of that sales force, whether it was a license that we no longer had, we got rid of, or it was an internal group of people that we had to let go as we structured it into a different model. And so Tad Fin seems to fit that model as well, because it's a BPH product, but it has other benefits, but BPH is a men's health and sexual health issue. And yes, we're in talks with telemedicine groups to help us launch that. And the power of telemedicine is that once the FDA makes the, assuming we get an approval, you push a button, and you've got all these patients in your universe, for the telemedicine universe, that you can bring in and begin to consult and then provide a prescription. And it's just amazingly efficient.

No longer had who got rid of or was it internal group of people that we know that we had to let go as we structured it into a into a.

A different model and so tad thin seems to fit that model as well because it has.

BPH product that has you know how the benefits, but you know BPH the men's health sexual health issue and ER and yes. We are in talks with Tele medicine groups to help us launch of that and the power of telemedicine is that once the FDA makes the.

I mean, we get an approval you push a button and you've got all these patients in Europe in your in your universe that.

For the telemedicine universe that you can bring in begin to cancels and then provide a prescription and it's just amazingly efficient.

So what do we continue to grow the sexual health business with other products. The answer is yes, why would we not even though our focus is prostate cancer and that kind of stuff and then we're going to continue to be focus in prostate cancer, that's our core business.

Mitchell S. Steiner: So, you know, would we continue to grow the sexual health business with other products? The answer is yes. Why would we not? Even though our focus is prostate cancer and that kind of stuff, and we're going to continue to be focused on prostate cancer, that's our core business, we will be opportunistic, particularly when it doesn't mean it costs our shareholders anything. If it's a matter of taking advantage of our contacts and growing the business, and we can do a deal where the other party makes money, we make money, but we're not spending money, and one plus one equals five in the core of the sexual health business, do that all day long. That's kind of what we're seeing now.

We will be opportunistic.

Particularly when it doesn't mean it costs our shareholders anything if it's a matter of taking advantage of our contacts and growing the business and and we can do a deal where the other party makes money, we make money, but we're not spending money and and you know one plus one equals five in the course sexual health business do that all day.

Long and that's kind of what we're seeing now I mean, when we've we've been we hit a critical mass in which.

Mitchell S. Steiner: We hit a critical mass where we're actually being called by these telemedicine groups to see if we have products for them. This is a very interesting time, and we're trying to adapt to it, and I think we've done a good job taking at least two products now, and soon a third product, and showing that this is real. We did this pre-COVID, and now I think COVID-19 going forward has disrupted the whole field, and we're kind of in the right place for that. Great, that's really helpful.

Well actually being called by these telemedicine groups to see if we have products for him.

No. This is this is a very interesting interesting time and I and we're trying to adapt.

To it and I think we've done a good job taking at least two products now and soon a third product and showing that this is real and we do this pre coated and now I think over 19 going forward is disrupted the the whole feel that though you know were what kind of in the right place for that.

Great. That's really helpful. Thanks for taking the questions I mean look forward to the data does mill.

Yi Chen: Thanks for taking the questions, and we look forward to the Data Desmo. Thank you. Appreciate it. Again, if you would like to ask a question, please press star then 1. To withdraw your question, press star then 2.

Thank you appreciate it.

Again, if you would like to ask a question. Please press Star then one to withdraw your question plus thought then to our next question is from Yi Chen from H.C. Wainwright go ahead.

Mitchell S. Steiner: Our next question is from Yi Chen from H.C. Wainwright. Go ahead. Hi, good morning.

Hi, Good morning. Thank you for taking my question Oh, the U.S prescription sales of ITSI to.

Yi Chen: Thank you for taking my question. The U.S. prescription sales of FC2 at $5.4 million in the fiscal third quarter seem to be lower than $7.0 million in the fiscal second quarter and $6.1 million in the fiscal first quarter. So could you give us some additional color on the dynamics of the U.S. prescription market and whether there's any seasonal trend or whether it is affected by COVID-19 at all? Thank you.

5.4 million Inc. fiscal second quarter.

Seems to be lower than 7.0 million during the fiscal second quarter and 6.1 million.

Fiscal first quarter, so could you give us some additional color on the dynamic off the U.S. prescription market and.

Whether there's any seasonal trend or whether it is affected by koby munching it'll. Thank you yes. Good. Good question. So the question is it looks like this quarter, there's a little dip in the U.S. prescription sales, even though over the over.

Mitchell S. Steiner: So the question is, it looks like this quarter there's a little dip in U.S. prescription sales, even though over the, you know, over the fiscal year, it's clearly, you know, we're way ahead. As I mentioned before, 159,000 prescriptions were written, 159,000 12-pack units were dispensed in fiscal year 2019, and in just this first three quarters, we're, you know, 200, whatever the number is So it's very big.

Over the fiscal year, it's clearly you know we're way ahead.

As I mentioned before hundred 59000 prescriptions were written a lot.

159012 pack units were dispensed.

In fiscal year, 2019, and and then just this first three quarters, where you know 200 and whatever the number is 239000 wherever the numbers. So it's big and it's going in and and so that means this next quarter or if it even even if it's an even core is going be a very it's going to be a record year. So the so I wanted to make it very clear that.

Michele Greco: And so that means this next quarter, even if it's an even quarter, it's going to be a very, it's going to be a record year. So I want to make it very clear that the U.S. prescription business is robust, and it is growing. What you're seeing is that the purchase orders that we get from the telemedicine groups don't necessarily fall with the quarters. And so some of that, I think you're seeing some of that dislocation. And COVID-19, I would argue that COVID-19 helped us with that dislocation rather than not, meaning that if there was some inventory, the inventory is quickly used up because of the fact that women are at home now using the internet. And what we've heard uniformly from the FC2 telemedicine providers, or I should say the customers, is that COVID-19 did indeed increase their business. And so I don't think COVID-19 is going away. So I think our next year is going to look robust as well. But I think some of that dislocation, again, is how we have the purchase orders come in. But I'll let Michele do that. Do you want to add a little color to that?

The U.S. prescription business is robust and it is growing.

What you're seeing is that the purchase orders that we get from the.

Tele medicine groups don't necessarily fall with the quarters.

And so some of that easy I think you're seeing some of that dislocation.

And and and Cobot 19.

I would argue to cope with 19 help this would that dislocation rather than not.

Meaning that if there was some inventory.

Inventories quickly you stopped because of the fact of women at home now using the into that and what we've we've heard uniformly from the FC too.

Tele medicine providers or as you say.

The the customers is that that covert 19 did indeed increase their business and so I don't think cobot nineteens going away. So I think our next year is going to look robust as well, but I think some that dislocation again is have would have the purchase orders come in but I'll, let Michele do you want to add a little color to that.

To that.

Sure there the other item that we did see was you know customers and working on building inventory.

Yi Chen: Sure, the other item that we did see was, you know, customers working on building inventory. And so they were figuring out how much inventory they wanted to keep on hand versus how quickly they placed orders and turned it around and had a sell through. And so we did, we did experience some of that. You know, and as Mitch said, our customers will put in a three-month purchase order and then pull down from that as they see fit. And that just doesn't coincide all the time with what we're seeing, you know, as we cut off our quarters.

And so they were you know and figuring out how much inventory they wanted to keep on hand versus how quickly they place orders and turn it around and have the sell through.

And so we did it we did experience some of that.

You know and as Mitch said, you know our customers will put in a three month purchase order and pull down from that as they see fit and that just doesn't coincide all the time with what we're seeing you know on as we cut off our corridors.

Okay. Thank you.

Mitchell S. Steiner: Okay, thank you. Thank you. Our next question is from Kumar Raja from Brookline Capital Markets. Go ahead. Hi, thanks for taking my questions. With regard to the prostate cancer trial, what is your expectation of the timing of meeting with the EMA and how do you think the expectations of EMA would be different compared to the FDA, and do you think you can incorporate the requirements of both the agencies in the single-phase retrial you are planning? Yeah, a good question.

Thank you.

Our next question is from Kumar Raja, Jeff from Brookline Capital markets go ahead.

Hi, Thanks for taking my question stuff.

With that without profit concept fire losses.

Timing of <unk> meeting a bit year may and.

I'll do you think the expectation, but yes, there would be different compared to their fee, a and b you'd think got Ukrainian caught up but it did.

That equipment both agencies in the single fit the profile you look bonding.

Yes. Good question. So the he may for everybody's European Medicines agency, and we are going to be running a global phase three in the intent is the intent is that this global phase three which served for registration both in U.S. and with the May.

Mitchell S. Steiner: So the EMA for everybody is the European Medicines Agency, and we are going to be running a global phase 3, and the intent is that the global phase 3 would serve for registration both in the U.S. and with the EMA. And so, with that said, you know, you have to pick and choose. And so, the first step is to get FDA input. The FDA and EMA have tried very hard to harmonize their advice globally. But just to be safe, we want to make sure that they agree. And I will tell you that, based on some of the other prostate cancer studies that have been done and have met with the EMA, that what the FDA is allowing us to do is not specific to us. This seems to be where the FDA has settled in terms of endpoints in this space.

And and so with that said.

We have to you've got to pick and choose and so the first step is to get FDA input.

The Ftn. He may have tried very hard to harmonize their advice.

Globally.

But just to be safe, we wanted to make sure that they agree and I will tell you that based on.

Some of the other prostate cancer studies that have been done and they have met with the amazed at what the FDA is allowing us to do is not specific to us.

It's a it seems to be that it seems to be with the FDA has set has settled in terms of endpoints in this space. So we are going to meet with the may probably late this year.

Mitchell S. Steiner: So we are going to meet with the EMA probably late this year. We're just starting the request. And part of that is that we just met with the agency in July. So this is what you would do.

We're just starting the request and part of that was we just met with the agency to let you know in July. So so this is what you would do and so now we're going to submit to M&A and get their advice, but the goal would be that in when we started our study in first quarter of calendar year 2021.

Mitchell S. Steiner: And so now we're going to submit to EMA and get their advice. But the goal would be that when we start our study in the first quarter of calendar year 2021, that it would have input from both agencies and that it would serve as a single phase three. And with regard to Veru 100, what remains to be done before you can go ahead and file the IND?

That would have input from both agencies and that it would serve as a single phase three.

And with regard to wait a 100 walk a walk to the last we'd done because you can go ahead and find by ending.

Mitchell S. Steiner: Oh, so all we're waiting for is all the non-clinicals to be done. Everything's done. The only thing that we're waiting on is GMP manufacturing. As you know, when you GMP manufacture a peptide, it's a little different, it takes a little bit more time, and you've got, you know, other issues all worked out. And so what we're doing now is just waiting for the final batch to be manufactured so that we can move forward. And you can't really file an IND until you have that CMC information. And so the CMC information, as soon as it's available, then we file the IND. And as you know, 30 days after that, you can start your trial. So it's literally just waiting for the last parts of the manufacturing to be done under GMP, and then we'll start phase two, you know, right at the end of the year or right at the beginning of the year. And that will be a small study, you know, a single injection, and that will guide us in what we need to do for phase three.

Oh to all we're waiting for that is the is the all all the Nonclinical is done everything's done only thing and we're waiting on his GMP manufacturing as you know when you GMP manufacture a peptide it's a little different it takes a little bit more time and you've got no other issues all worked out.

And so what we're doing now is just waiting for the for the final batch to be a manufacturers. So that we can move forward and you can't really file a 90 into you have that CMC information and so the so the CMC information. We will soon is available then we're finally, the I'd and as you know 30 days after that you can start to trial.

So literally just waiting for the last parts of the manufacturing to be done on the GMP.

And and then we'll start to phase two.

If.

Not right at the entity year to be right at the beginning of the year and that will be a small study single injection and that will guide us and what we need to do for the phase I phase three.

So we're close.

Kumar Raja: So, we're close. Thank you. Ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the conference back over to Dr. Mitchell Steiner for closing remarks. I appreciate you joining us on today's call, and I look forward to updating all of you on our progress at our next Investors Call. Thank you for joining us. The digital replay of the conference will be available beginning at approximately noon Eastern Time today, August 13th, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 101-466-52. Please record your name and company when joining. The conference is now concluded. Thank you for attending today's discussion. You may now disconnect.

Thank you.

All right.

Okay.

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

I appreciate you joining us on today's call and I look forward to updating all of you on our progress at our next investors call. Thank you for joining us.

So digital replay of the conference will be available beginning approximately noon eastern time today August 13th by dialing 1877 series for 75 to nine in the U.S.

And well one final 12317 0088 internationally.

Yeah, well be prompted to enter the replay access code, which will be one no. One for 665 to please record your name and company when joining.

The conference has now concluded. Thank you for attending today's discussion you may now disconnect.