Q1 2022 Veru Inc Earnings Call

[music].

Speaker 1: Good morning ladies and gentlemen and welcome to Verun, Inc.'s investors conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions.

Good morning, ladies and gentlemen, and welcome to Varian, Inc. Investors Conference call all participants will be in a listen only mode. So do you need assistance. Please signal a conference specialist by pressing the sparky followed by zero.

After this mornings discussion there'll be an opportunity to ask questions. Please note that this event is being recorded.

Speaker 1: Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fishe, Verus, Inc's Executive Director Investor Relations and Corporate Communications. Mr. Fishe, please go ahead.

Now I'd like to turn the conference over to Mr. Stances Perez Inc's executive director of Investor Relations and corporate communications.

Please go ahead.

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

Speaker 2: Good morning. Statements made on this conference call may be followed with some statements.

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

Speaker 2: Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development of product portfolios.

Speaker 2: Such forward-looking statements are subject to known and unknown risk uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statement.

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

Speaker 2: Risks that may cause actual results or development to different materially are contained in our 10Q and 10K SEC filings, as well as in our press releases from time to time. I'd now like to turn the conference call over to Dr. Mitchell Steiner, G Gigiilateral Finance Chairman, CEO and President of figure one funds.

Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings as well as in our press releases from time to time I would now like to turn the conference call over to Dr. Mitchell Steiner <unk>.

<unk>, Chairman CEO and president.

Good morning.

Speaker 2: Good morning. With me on this morning's call are Michelle Greco, CFO , CAO, Michael Purves, Executive Vice President, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. VIRU is dedicated to the development of novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer.

With me on this morning's call are Michele Greco CFO CEO , Michael purpose Executive Vice President and General Counsel and corporate strategy and Sam Fisch Executive director of Investor Relations and corporate communications. Thank you for joining our call here. It was dedicated to the development of novel medicines for the management as to.

The most prevalent cancers breast cancer and prostate cancer, one of our anti cancer types of visibility has dual antiviral and anti inflammatory effects. So it is also being developed for the potential treatment hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, which remains a global.

Speaker 2: One of our anti-cancer drugs, Abizibulone, has dual antiviral and anti-inflammatory effects, so it is also being developed for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, which remains a global dire unmet medical need.

Higher unmet medical need.

I think he has a commercial sexual health division called you read which includes two FDA approved products and Tad fee, a new treatment for BPH or benign prostatic hyperplasia and the F. C. Two female condom internal condom to the dual protection against unplanned pregnancy and the transmission is sexually.

Speaker 2: The company has a commercial sexual health division called URAV, which includes two FDA approved products.

Speaker 2: and TADV, a new treatment for BPH, which is benign prostatic hyperplasia, and the FC2 female condom, internal condom, for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.

Infections.

Speaker 2: The revenue from the Sexual Health Division is being used to largely fund the clinical development of our late-stage drug candidate assets, which aim to address multi-billion dollar premium market opportunities.

Revenue from the sexual health Division is being used to largely fund the clinical development of our late stage drug candidate assets, which aimed to address multibillion dollar premium market opportunities.

Good morning, we will discuss <unk> business strategy, the clinical development of our drug pipeline and the commercialization of our products.

Speaker 2: This morning, we will discuss Bureau's business strategy, the clinical development of our drug pipeline, and the commercialization of our products. We will also provide financial highlights to our first quarter fiscal year 2020.

Also provide financial highlights for our first quarter fiscal year 2022.

COVID-19, global cases, hospitalizations and deaths were at the highest level since the start of the pandemic. Some of the antibody drugs did not affect it that gets you on the contrary it is clear that an effective and safe oral therapeutics that prevents deaths in hospitalized patients with moderate to severe COVID-19.

Speaker 2: COVID-19 global cases, hospitalizations and deaths were at the highest level since the start of the pandemic.

Speaker 2: Some of the antibody drugs are not effective against the Omicron variant.

Speaker 2: is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 infection would high risk for acute restful distress and illness deaths that we needed. We strongly believe that to be dealing with its antiviral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized patients with COVID-19.

Section with high risk for acute Westwood distress syndrome is desperately needed.

<unk> believes its a busy dealing with its antiviral and anti inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized patients with COVID-19.

So basic Beulah and disrupts the intracellular transported the corona viruses by microtubules. This is it.

Speaker 2: Visibulin disrupts the intracellular transport of the coronaviruses by microtubules. This is a process that's required by all variants of COVID-19, including Omercon to cause infection. While there have been recent developments evaluating the Merck JAG, Molybdenum, and the Pfizer drug Paxilovir.

Process, that's required by all variance of COVID-19, including <unk> to cause infection.

While there have been recent developments, you're valuing the mercury multi period and the Pfizer drug tax low bid.

Speaker 2: for the treatment of unhospitalized patients with mild to moderate COVID-19 who had relatively low risk of dying, sebizibulin in contrast is being developed for hospitalized patients with moderate severe COVID-19 who are at high risk of death.

For the treatment of hospitalized patients with mild to moderate COVID-19, who had relatively low risk of dying. She busy Beulah and contrast is being developer hospitalized patients with moderate and severe COVID-19.

Who are at high risk of death.

Our positive phase II clinical study in hospitalized COVID-19 patients I wish to acute respiratory distress syndrome showed that the visit bulent treatment resulted in 882% relative reduction in deaths compared to placebo, if our phase II clinical results replicated to any significant degree in our global phase III clinical study.

Speaker 2: Our positive phase two clinical study in hospitalized COVID-19 patients I wish we acute restful distress syndrome shows that the visible treatment we resulted in 82% relative reduction in desk compared to placebo. If our phase two clinical results replicated to any significant degree in our global phase three clinical study, we believe the visible and the city I'm not meant to believe the hospitalized patient.

We believes to visit Bill.

Unmet medical need for hospitalized patients we are conducting a phase III COVID-19 clinical study.

Speaker 2: We are conducting a phase three COVID-19 clinical study, which is a double-blind, multi-sensored, multinational, randomized two-to-one placebo-controlled study evaluating daily oral 9-milligram dose of sub-isopule in up to 21 days versus placebo in 300 hospitalized COVID-19 patients with high risk for acute respiratory distress in goingITCH issue.

<unk> is a double blind multicenter multinational randomized two to one placebo controlled study evaluating daily oral nine milligram dose of <unk> for up to 21 days.

Versus placebo and 300 hospitalized COVID-19 patients with high risk for acute respiratory distress syndrome.

Primary efficacy endpoint will be the proportion of patients who die off study up to date 60 secondary endpoints will include the proportionate patients without respiratory failure stays in the ICU W. H O ordinal scale clinical improvement change from baseline data on mechanical ventilation days in the hospital and viral load studies.

Speaker 2: The primary emphasis standpoint will be the proportion of patients who die on study up to day 6.

Speaker 2: Secondary endpoints will include the proportion of patients without respiratory failure, days in the ICU, WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load.

Speaker 2: Studies being conducted in the US, Brazil, Argentina, Mexico, Colombia, and Bulgaria.

<unk> conducted in the U S, Brazil, Argentina, Mexico, Colombia and Bulgaria.

Speaker 2: In January of 2022, the FDA granted fast track designation to the Phase 3 COVID-19 registration program, a distinction that underscores the urgent need for new novel and effective therapies to be used along with vaccinations to combat this COVID-19 pandemic.

In January of 2022, the FDA granted fast track designation for the Phase III COVID-19 registration program, a distinction that underscores the urgent need for new novel effective therapies to be used along with vaccinations to combat. This COVID-19 pandemic the company has sufficient clinical.

Speaker 2: The company has sufficient clinical drugs to apply on hand to complete the phase three clinical study and to help fund a commercial drug to supply the needs of the U.S. population, assuming confirmatory positive clinical results and FDA approval. We're seeking funding from Barda and Abhaz.

Doug supply on hand to complete the phase III clinical studies and to help fund the commercial drug supply the needs of the U S population, assuming confirmatory positive clinical results and FDA approval, we're seeking funding from BARDA and other agencies.

Speaker 2: Company anticipates having the results of the phase three COVID-19 clinical trial in the first half of calendar year 2020.

We anticipate having the results of the phase III COVID-19 clinical trial in the first half of calendar year 2022.

Speaker 2: As for our breast cancer drug portfolio, we have an expansive metastatic breast cancer program with two of our drug candidates, Enobisarm and Subizibule. Enobisarm is an oral selective androgen receptor targeting agonist, which has shown efficacy in phase two clinical studies in a heavily pretreated hormone receptor positive metastatic breast cancer patient population with an excellent safety profile without causing unwanted masculinizing adverse guidance.

As for our breast cancer drug portfolio, we have an expansive metastatic breast cancer programs with two of our drug candidates <unk> and <unk>.

<unk> is an oral selective androgen receptor targeting agonist, which has shown efficacy in phase II clinical studies in a heavily pretreated hormone receptor positive metastatic breast cancer patient population with an excellent safety profile without causing unwanted masculinizing adverse side effects.

Speaker 2: Novus arm represents the first and novel endocrine therapeutic approach to breast cancer in decades.

<unk> represents the first and novel endocrine therapeutic approach to breast cancer in decades.

Speaker 2: Our second drug candidate to bizibulin is an oral cytoskeleton disruptor that targets unique binding sites and cross-linked microtubules, a well-validated cancer target resulting in promising efficacy and a favorable safety profile without clinically relevant neurotoxicity, neutropenia, or alopecia. Furthermore, chronic oral daily administration to bizibulin is feasible.

Our second drug candidate to visit view and there's an oral side a skeleton disruptor that targets unique binding sites in cross linked microtubules, well validated cancer target, resulting in promising efficacy and a favorable safety profile without clinically relevant neurotoxicity and neutropenia or alopecia. Furthermore plant.

Nick oral daily administration CBS viewing is feasible.

A nickel development strategy allows us the potential to become an important treatment option for a variety of large market opportunities in hormone receptor positive metastatic breast cancer.

Speaker 2: A clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in hormone receptor positive metastatic breast cancer.

In the third line treatment setting for hormone receptor positive metastatic breast cancer, we have two clinical programs based on the patient's androgen receptor nuclear staining where expression levels in the breast cancer tissue.

Speaker 2: In the third line, treatment study, the hormone we stepped to positive metacetic breasts.

Speaker 2: We have two clinical programs based on the patient's answer-gen receptor nucleotid staining or expression levels in the breast cancer tissue.

Patients with greater than equal to 40% answered receptor expression. We are actively enrolling a global phase III, our tests registration clinical study to evaluate and notebooks arm monotherapy with a third line treatment of ER positive <unk> positive her two negative metastatic breast cancer.

Speaker 2: Patients with greater than equal to 40% answer receptor expression, we are actively enrolling a global phase three art test registration clinical study to evaluate a novosar monotherapy for the third line treatment of AR positive, AR positive, her two negative, metastatic threats.

Speaker 2: Enovus arm targets the answer receptor, which has tumor suppressor activity in AR positive, ER positive, HER2 negative metastatic breast cancer without causing the unwanted masculinizing side effects. Enovus arm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies and approximately 1,450 patients dose, including three phase two clinical studies in advanced breast cancer involving more than 250 patients.

<unk> targets, the Andrew receptor, which has tumor suppressor activity and they are positive ER positive <unk> negative metastatic breast cancer without causing the unwanted masculinizing side effects <unk> has extensive non clinical and clinical experience haven't been evaluated in 25 separate clinical studies and approximately 1004.

50 patients dose, including three phase III clinical studies and advanced breast cancer are involved in more than 250 patients. This means we have a very good understanding of the favorable safety profile with an overstock as for efficacy with two phase III clinical studies conducted in women with ER positive <unk> positive or negative.

Speaker 2: This means we have a very good understanding of the favorable safety profile in the Nova.

Speaker 2: As for efficacy, there were two phase two clinical studies conducted in women with AR positive, AR positive, or two negative metastatic breast cancer, where Inovisarm demonstrated significant anti-tumor efficacy in a heavily pretreated cohort that developed tumor progression after receiving estrogen blocking agents, chemotherapy, and or CDK46 inhibitors. And again, in this population, Inovisarm was well tolerated with a favorable safety profile.

<unk> metastatic breast cancer with Novus arm demonstrated significant anti tumor efficacy in heavily pretreated cohorts that developed tumor progression after receiving estrogen blocking agents chemotherapy and or CDK four six inhibitors and again in this population <unk> well was well tolerated.

With a favorable safety profile.

We are conducting a phase III multicenter International open label randomized one to one our test registration clinical trial to evaluate the efficacy and safety of <unk> monotherapy versus an active comparator, either exemestane, plus or minus I, miss or a selective estrogen receptor.

Speaker 2: We are conducting a Phase III multi-center international open label, Randomize 1-to-1 Artest Registration Clinical Trial, to evaluate the advocacy and safety of an open-sign monitor.

Speaker 2: versus an active comparator of either X and M S, A plus or minus every alignness, or a selective estimate to modulate it for the treatment AR positive, ER positive, or two negative menace ed breast cancer in approximately 210 patients with greater than or equal to AR expression in the breast cancer tissue, who have previously received a non-seware limitation inhibitor for vestricant and CDK468.

Modulator for the treatment ER positive <unk> positive <unk> negative metastatic breast cancer, and approximately 210 patients greater than or equal to.

A R expression in the breast cancer tissue, who have previously received <unk> non soy willow mutation inhibitor for investment and CDK four six enabler.

Speaker 2: January of 2022, FDA granted fast track destination to our Phase 3 R test registration program.

January of 2022, FTA granted fast track designation to our phase III <unk> test registration program.

Speaker 2: Fast-track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.

Fast track designation aims to expedited development and review of new drugs that are intended to treat serious or life threatening conditions and demonstrate the potential to fill unmet medical needs filling an unmet medical need is defined as providing a therapy with non exist, while providing a therapy, which may be potentially better than available.

<unk>.

Patients were found to have less than 40% <unk> expression in the breast cancer tissue. We have the plants SR step, which is an open label multicenter randomized one to one phase <unk> study evaluating the efficacy and safety of <unk> 32 milligrams monotherapy versus the active comparative either exemestane plus or minus that.

Speaker 2: Patients who have found to have less than 40% AR expression in their breast cancer tissue. We have a planned sister study.

Speaker 2: which is an open label multi-center randomized once one stays to be studied. Evaluating the efficacy and safety as a visit you'll have 32 milligrams of monofere.

Speaker 2: versus the active comparatively either XMS pain plus a minus F relime or serum for the treatment of ER pods and ER pods and medesthetic breast cancer and approximate 200 patients who have previously received a non-sauware of a limitation of COVID-19 or a Vestrant and CDK 460 inhibitor. For clarity, this means we have a specific...

<unk> or <unk> for the treatment of your positive ER positive metastatic breast cancer and approximately 200 patients who have previously received is that sort of a one with ace inhibitor, so veteran and CDK four and six inhibitor for clarity. This means we have the sister step into.

Speaker 2: to randomize patients that did not qualify for the Phase III Arche study because their AR expression and the breast cancer tissue was too low. We received the Fave to Proceed Letter from FDA. In this Phase II V study, suspected to commence, and count to Q1 2022.

Randomized patients that did not qualify for the phase III <unk> study because there <unk> expression in the breast cancer tissue was too low.

Received the safe to proceed letter from FDA in this phase <unk> study is expected to commence in calendar Q1 2022.

We're also moving in Opus on therapy earlier in the treatment sequence into the second line treatment settings for <unk>.

Speaker 2: We're also moving a novosompti-erotene earlier in the treatment sequence into the second line treatment setting for AR positive, ER positive, or her two negative metastatic breast cancer by targeting patients with AR positive breast cancer expression of greater than equals 40% in a phase three enabler two clinical study.

<unk> ER positive <unk> negative metastatic breast cancer by targeting targeting patients with ER positive breast cancer expression of greater than equal to 40% in a phase III enable her to clinical study.

CDK four six inhibitor and an estrogen blocking agent combination has become the first line therapy for patients with ER positive <unk> negative advanced breast cancer.

Speaker 2: CDK-4-6 inhibitor and an estrogen blocking agent combination has become the first line therapy for patients with ER positive HER2 negative advanced breast.

Fortunately almost all patients will develop drug resistance and will eventually developed breast cancer progression based on positive phase II clinical data and the preclinical data supporting the use of <unk> in combination with CDK <unk> inhibitor in patients who are CDK four six inhibitor, an estrogen blocking agent resistant.

Speaker 2: Unfortunately, almost all patients will develop drug resistance and will eventually develop breast cancer progression. Based on positive phase 2 clinical data and the preclinical data supporting the use of the docuSAR in combination with a CDK46 inhibitor in patients who are CDK46 inhibitors and estrogen blocking agent resistant.

Speaker 2: We plan to conduct a phase three multi-sensor open label randomized one-to-one active control registration clinical study named Enabling 2. I wait the efficacy and safety of the Novosar and Abemacyclic combination therapy versus an alternative

We plan to conduct a phase III multicenter open label randomized one to one active control registration clinical study named enabled with tube.

Great the efficacy safety and overtime and a better site with combination therapy versus an alternative.

Estrogen blocking agent in subjects with ER positive <unk> positive virtue metastatic breast cancer, who have failed first line therapy with tableau stick with which is the CDK <unk> inhibitor, plus an estrogen blocking agents, who have greater than equal to 40% <unk> expression in the breast cancer tissue.

Speaker 2: estrogen-blocking agent and subjects with AR-positive, URP-positive, or 2-menesthetic breast cancer who have failed first-line therapy with Pablo Steklitz, which is a CDK-46 inhibitor plus an estrogen-blocking agent and who have greater than or equal to 40% AR expression in the breast cancer tissue.

Speaker 2: plans to involve approximately 186 patients in this phase 3 clinical study. We recently announced that we have entered into a clinical trial collaboration and supply agreement with Lilly for the Enabler 2 phase 3 clinical study.

<unk> one was approximately 186 patients in this phase III clinical study, we recently announced that we have entered into a clinical trial collaboration and supply agreement with living with.

With the enabler to phase III clinical study.

In terms of the nonexclusive clinical trial collaborations supply agreement bureaus responsible for conducting the clinical trial, while Lilly will supply of <unk> to the study room maintains full exclusive global rights to Nobu, sorry, we're looking forward to our collaboration with Liberty of the enablers to phase III clinical trial, which is.

Speaker 2: In terms of the non-exclusive clinical trial collaboration supply agreement, Bureau is responsible to conduct the clinical trial, while Lily will supply a domestic list of the study. Bureau maintains full exclusive global rights to an oversaw. We're looking forward to our collaboration ability on the Enable of Two Phase Three clinical trial, which is expected to commence in calendar Q1 2022.

<unk> to commence in calendar Q1 2022.

But partnering with Roche Ventana, a major global diagnostics company to develop a companion diagnostic answer except to test in the phase II <unk> study, we determined that the present and the amount of the androgen receptor expression in breast cancer tissue or importantly, notebooks arms targeted antitumor activity.

Speaker 2: The partnered with Roach Ventana, a major global diagnostic company to develop a companion diagnostic, answering step-to-step test.

Speaker 2: In the phase two, eight of one study, we determined that the presence and the amount of the angio-receptor expression in breast cancer tissue are important for the nervous arms targeted anti-tumor activity. In fact, we identified that patients who have greater than or equal to 40% angio-receptor stating by immunohistochemistry, which is a measure of angio-receptor expression in the breast cancer tissue, are the patients that are most likely to have an anti-cancer response to a nervous.

We identify the patients who have greater than equal to 40% androgen receptor staining by immunohistochemistry, which is a measure of answering receptor expression in the breast cancer tissue, where the patients that are most likely to have an anti cancer response to <unk> based on this observation the FDA recommended that we develop a can.

Speaker 2: Based on this observation, the FDA recommended that we develop a companion diagnostic test to determine the patient's AR expression status. Consequently, we have partnered with Bush-Ventana Diagnostics.

Pena diagnostic tests to determine the patients expression status. Consequently, we have partnered with Roche Ventana diagnostics World leader in oncology companion diagnostic test, we are developing and as approved plans to commercialize the companion diagnostic Andrew receptor test.

Speaker 2: world leader in oncology companion diagnostic tests where developing and is approved, plans to commercialize the companion diagnostic and intercept.

Pain diagnostic test is being developed in parallel with the phase III <unk> clinical study.

Speaker 2: companion diagnostic test is being developed in parallel to the phase 3 R-test clinical study.

No. The study although the company is planning to commence a single arm <unk> plus <unk> combination the metastatic triple negative breast cancer patients in a phase II clinical studies were supposed to start early in this calendar year, we have now decided to focus our finite resources on more advanced pipeline.

Speaker 2: No other study, although the company has been planning to commence a single arms to visit Buehl and Pleasant Nova Farm combination, the Medisatic Triple Negative Rescue Rescue Rescue Conservation Foundation.

Speaker 2: and a phase two clinical study that was supposed to start early in this calendar year. We have now decided the focus of finite resources on more advanced pipeline opportunities. This has been work on this trial. Nevertheless, the company may have committed to advancing triple-megapres cancer study in the future. As you can see, we have developed an important and deep breast cancer program, dedicated to developing not-

Opportunities to suspend work on this trial. Nevertheless, the company remains committed to advancing triple negative breast cancer study in the future as you can see we have developed an important and deep breast cancer program dedicated to developing novel.

Okay.

Speaker 2: We have late clinical stage studies addressing three separate indications.

We have late clinical stage studies addressing three separate indications first indication is evaluating <unk> in the third line treatment of metastatic castration resistant prostate cancer in the phase III veracity study.

Speaker 2: The first indication is evaluating sebizibulone, the third line treatment of metastatic castration-resistant prostate cancer, in the Phase III veracity study. All novel entries have been targeted.

Several novel androgen receptor targeted.

Diluted by an absolute amount.

Fortunately most men with metastatic castration resistant prostate cancer, who will develop tumor progression, while receiving and Andrew said the targeted agents with 60% to 70% of patients progressing by 12 to 18 months and 30% to 40% of men, having no benefit at all new effective and well tolerated treatment alternatives that do not target to Angela <unk>.

Speaker 2: Fortunately, most men with metastatic castration resistant prostate cancer will develop tumor progression while receiving an answer receptor targeted agent, which takes you to 70% of patients progressing by 12 to 18 months. In 30 to 40% of men having no benefit at all. New, effective, and well-collarated treatment alternatives that do not target the answer receptor access and that have an easy mode of administration or greatly needs.

Scepter axis and that have an easy mode of administration are greatly needed to.

Speaker 2: Abitibulin is a member of a novel class of drugs that disrupts the cytoskeleton by targeting unique binding sites on microtubules, which results in improved safety profiles.

<unk> is a member of a novel class of drugs that disrupts the side the skeleton by targeting unique binding sites on microtubules reserve, which would result in an improved safety profile.

Speaker 2: Preclinical models, there is no evidence of significant liver toxicity, liver toxicity, and neutropenia, which is a visibule in treatment. There is more tolerable safety profile. It has also been confirmed in a first in man phase 1P2 study in Medestata Casteration, which is in prostate cancer patient.

Preclinical models, who has no evidence of significant liver toxicity.

Zero toxicity neutropenia, which debuted in treatment is more tolerable safety profile has also been confirmed in a first in man phase one two study in metastatic castration resistant prostate cancer patients, we will be presenting updated clinical data from the positive phase <unk> study of <unk>.

Speaker 2: We will be presenting updated clinical data from the positive phase 1B2 study of submissive urine and 80 men with metastatic castration resistant prostate cancer. We have progressed on at least one novel answer we stepped to target.

Visit Bulent 80 men with metastatic castration resistant prostate cancer, who have progressed on at least one novel Andrew receptor targeting agents.

At the <unk> Genitourinary cancers symposium being held February 17 to 19 in San Francisco, California.

Speaker 2: At the ASCO, Janet, to your honorary cancer symposium, being held February 17th and 19th, in San Francisco, California.

Is conducting an open label two to one multi center phase III veracity clinical study evaluating <unk> <unk> 32 milligrams versus an alternative androgen receptor targeted agent for the treatment of chemotherapy naive men with metastatic castrate resistant prostate cancer, who had tumor progression after <unk>.

Speaker 2: is conducting an open label to one multi-center phase three veracity clinical study evaluating the visual in 32 milligrams versus an alternative answer receptor target agent for the treatment of chemotherapy naive men that men at a cast rate resistant prostate cancer who had tumor progression after previously receiving at least one and receptor target agent primary endpoint is radiographic progression

Obviously, receiving at least one antigen receptor targeted agents.

Endpoint is radiographic progression free survival.

Speaker 2: The Romans have faced three brassy clinical studies on track. We expect to enroll approximately 245 patients from 45 clinical centers in the U.S.

The phase III <unk> clinical studies on track and we expect to enroll approximately 245 patients from 45 clinical centers in U S.

The full study.

It is evaluating <unk> 100, with a gnrh antagonist three month depot formulation in a phase II dose finding clinical study for the treatment of hormone sensitive advanced prostate cancer.

Speaker 2: evaluating Bureau 100, a GNRH and TACNESS, a three-month-people formulation, in a phase two dose-clinical study for the treatment of hormones-fensitive advanced-cost vacants.

Speaker 2: And the deprivation therapy remains the main state primary therapies for advanced prostate cancer. But current answered deprivation therapy drug products have several important clinical shortfalls. LHRH Agonis, initial administration, leads to a testosterone surrogic in the last up to 21 days. Thermagon, a GNRH antagonist, is a large volume subcontains injection formulation designed to only a single month relief.

And deprivation therapy remains the mainstay primary therapy for advanced prostate cancer, but current androgen deprivation therapy drug products have several important clinical shortfalls LHRH agonist initial administration leads to a testosterone surge. It can last up to 21 days for Mcgovern the GNL.

<unk> antagonist is a large volume subcutaneous injection formulation designed for only a single months beliefs.

<unk> is an oral gnrh antagonist, but has the potential to poor patient compliance and contrast, Mir 100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercially available androgen deprivation therapy products tier 100 is a law.

Speaker 2: And Regal Golex is an oral G-RH antagonist that has the potential for poor phasing compliance. In contrast, Viral 100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercially available Android deprivation therapy product.

Speaker 2: FEAR100 is a long-acting GNRH antagonist designed to be administered as a small-volume, subcutaneous three-month depoject.

Long acting gnrh antagonist designed to be administered as a small volume subcutaneous three month depot injection.

Speaker 2: If you're 100 drug platics expected to immediately suppress testosterone with no testosterone surge, and if you're 100, if you're long acting injected deep, well, with insured patient compliance, well, on treatment, furthermore, as the class, GNRH antagonists have been shown to have fewer cardiovascular adverse events than LHRH act.

100 drug product is expected to immediately suppress testosterone with no testosterone surge in figure 100 is a long acting injectable depot with insured patient compliance while on treatment. Furthermore, at the class Gnrh antagonists have been shown to have fewer cardiovascular adverse events than LHRH agonist.

<unk>.

Speaker 2: We're conducting a phase two dose finding clinical study of Euro 100 angio deprivation therapy in 35 men with hormone sensitive advanced prostate cancer. Although this study is ongoing, we preliminary clinical data from trauma.

We are conducting a phase II dose finding clinical study of VB 100, androgen deprivation therapy.

And 35 men with hormone sensitive advanced prostate cancer. Although this study is ongoing and preliminary clinical data promising.

Speaker 2: Three Registration Clinical Study Design has already been agreed upon with FDA. It will be a single-hour study which will enroll approximately 100 men. Maintenance of castrate blood concentrations of testosterone is the primary.

Three registration clinical study design has already been agreed upon with FDA, we will be a single arm study, which will enroll approximately 100 men maintenance of castrate blood concentrations of testosterone is the primary endpoint after the phase II dose finding studies completed we will initiate the phase III clinical study, which is anticipated to begin.

Speaker 2: After the Phase II dose finding studies completed, we will initiate the Phase III clinical study which is anticipated to begin in the calendar's second half of 2022.

The calendar second half of 2022.

Speaker 2: In our third late-stage clinical study, the plan to expand succelomaphines for treatment populations caused by antidefication therapy and a plan phase 2B clinical study later in the calendar year of 2022. So in summary, we'll have three late-stage clinical studies for the management of advanced prostate cancer in calendar year 2022.

And our third late stage clinical study, we plan to advance to quote machines. The treatment plant flashes caused by androgen deprivation therapy and a planned phase II clinical study later in the calendar year 2022. So in summary, we will have three late stage clinical studies for the management and advanced prostate cancer and calendar.

Year 2022.

Now Bureau has a commercial sexual health division called <unk>, which includes two FDA approved products FC too for the dual protection again.

Speaker 2: Now, Viru has a commercial sexual health division called URAD, which includes two FDA approved products, FC2 for the dual protection against-

Across the U S.

Speaker 2: across the U.S. As a result, FC2 is now available through multiple sales channels. In particular, we have partnered with fast growing, highly reputable, telemedicine platform companies to bring our FC2 product to patients in a cost, effective, and highly convenient.

As a result, <unk> is now available through multiple sales channels. In particular, we had partnered with fast growing highly reputable telemedicine platform companies to bring our MCT product to patients in a cost effective and highly convenient manner.

Speaker 2: is not only to seek additional telemedicine and internet pharmacy service partners, but also to create our own. That is...

Sales is not only to seek additional telemedicine and Internet pharmacy service partners, but also to create our own data.

Steve has.

Speaker 2: has been shown to be more effective for the treatment of benign prosthetic hypochlaia than finasteride alone without causing impetus.

<unk> shown to be more effective for the treatment of benign prostatic hyperplasia that finasteride alone without causing impotence and tasking was approved by FDA in December of 2021, and commercialization plans are now underway.

Speaker 2: And Tasty was approved by FDA in December of 2021 and commercialization plans are now underway.

The plan to officially launch in chassis next quarter tapping is expected to be marketed and distributed also by our own direct to patient telemedicine and Internet pharmacy services platform. We have we have also partnered with Rx a U S based digital resource to health care to reach their almost 20.

Speaker 2: The plan is to officially launch in CASTB next quarter. CASTB is expected to be market and distributed, also by our own directorate patient, telemedicine, and internet pharmacy services.

Speaker 2: We have also partnered with GoodRx, a US-based digital resource for help.

Speaker 2: to reach there are almost 20 million monthly visitors, which include both consumer and healthcare providers to build awareness, to send patients to our telemedicine platform, and to convert existing men on BPH treatments. Those treatments that call a sexual side effects to intact.

<unk> million monthly visitors, which include both consumer and health care providers to build awareness to send patients to our telemedicine platform and to convert existing man on BPH treatments those treatments at Cowen sexual side effects to intact.

There are over 45 million prescriptions filled annually for drugs to treat BPH, we plan to augment our marketing and sales separately by seeking additional partners in the U S and ex U S. I will now turn the call over to Michele Greco.

Speaker 2: There are over 45 million prescriptions filled annually for drugs to treat BPH. The plans to augment our marketing and sales clefers by seeking additional partners in the US and XUS. I will now turn the call over to Michelle Greco, the CFO and CEO to discuss the financial highlights. Michelle?

<unk> as CEO to discuss the financial highlights Michelle.

Thank you.

Speaker 3: Thank you, Dr. Sainer. If Dr. Sainer indicated, I accompanied the number of significant clinical trials. So.

Is that just that and you indicated the company a number of significant clinical value.

Thank you the first quarter results.

Speaker 3: Net revenues were $14.1 million compared to $14.6 million in the prior year quarter.

Net revenues were $14 1 million compared to $14 $6 million in the prior year quarter.

The prior year quarter included net revenues of $863000 related to pre Bruce which the company settled in December eight of 2020.

Speaker 3: The prior year quarter included net revenues of $863,000 related to pre-buse, which the company sold on December 8th of 2020.

Speaker 3: Company reported FC2 sales growth in its US prescription business with net revenues of 27 percent to $11.6 million from $9.1 million in the prior year quarter.

Company reported <unk> sales growth in its U S prescription business with net revenues up 27% to $11 6 million from $9 $1 million in the prior year quarter.

Speaker 3: Net revenues for the public sector business were $2.6 million compared to $4.7 million in the prior year quarter.

Net revenues for the public sector business were $2 $6 million compared to $4 $7 million in the prior year quarter.

The prior year quarter included revenues related to the Brazil, and South Africa tenders.

Speaker 3: The prior year quarter included revenues related to the Brazil and South Africa contender.

Speaker 3: Overall gross profit was $11.8 million or 84% of net revenues compared to $10.8 million or 74% of net revenues in the prior year quarter.

Overall gross profit was $11 $8 million or 84% of net revenues compared to $10 $8 million or 74% of net revenues in the prior year quarter.

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

Speaker 3: The increase in gross profit and gross margin is driven primarily by increased sales in our USFC2 prescription business.

This quarter's 84% gross margin is the highest in the company's history.

Speaker 3: This quarter's 84% gross margin is the highest in the company's history.

Operating expenses for the quarter increased to $16 $8 million compared to the prior year quarter of $10 $1 million.

Speaker 3: Appritting expenses for the quarter increase to $16.8 million compared to the prior year quarter of $10.1 million.

Speaker 3: The increase is primarily driven by research and development costs, which increase to $10.1 million from $5.7 million in the prior year quarter and increases in personnel and related costs to prepare to commercialize and tap the.

The increase is primarily driven by research and development cost, which increased to $10 $1 million from $5 $7 million in the prior year quarter and increases in personnel and related cost to prepare to commercialize and TNT.

Speaker 3: During the prior year quarter, the company sold pre-glues for $20 million. $15 million in cash and $5 million in notes receivable due in two installments over an 18-month period.

During the prior year quarter. The company sold three boost for $20 million $15 million in cash and $5 million in notes receivable due in two installments over an 18 month period.

Speaker 3: The sale of pre-bluest resulted in an 18.4 million dollar pre-ticks game.

The sale of <unk> resulted in an $18 $4 million pre tax gain.

The operating loss for the quarter was $5 million compared to operating income of $19 $2 million from the prior year quarter. This change is primarily due to the gain on sale of pre boost at $18 $4 million plus the increase in research and development cost of $4 $4 million.

Speaker 3: The operating loss for the quarter was $5 million compared to operating income of $19.2 million in the prior year quarter. This change is primarily due to the gain and sale of pre-boost of $18.4 million plus the increase in research and development costs of $4.4 million.

Non operating expenses were $1 $3 million compared to $1 $9 million from the prior year quarter, and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing we entered the synthetic royalty financing during March of 2008.

Speaker 3: Non-operating expenses were $1.3 million compared to $1.9 million in the prior year quarter, and primarily consisted of interest expense and change in the fair value of the derivative liability related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.

<unk>.

Speaker 3: For the quarter, we recorded a tax expense of $115,000, compared to $78,000 in the prior year quarter. The bottom line results for the quarter was a net loss of $6.4 million or $8 per diluted common share, compared to net income of $17.2 million, or $23 per diluted common share in the prior year quarter.

For the quarter, we recorded a tax expense of $115000.

$78000 in the prior year quarter.

The bottom line results for the quarter was a net loss of $6 $4 million or <unk> <unk> per diluted common share compared to net income of $17 $2 million or 23 per diluted common share in the prior year quarter.

Speaker 3: The company has net operating loss carry forwards for US federal tax purposes of $38.6 million with $29.5 million expiring in years through 2040 and $9.1 million which can be carried forward indefinitely. Anner UK subsidiary has net operating loss carry forwards of $63.5 million which did not expire.

The company has net operating loss carryforwards for U S. Federal tax purposes of $38 $6 million with $29 5 million expiring in years through 2040, and $9 $1 million, which can be carried forward indefinitely.

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

Now looking at the balance sheet as of December 31, 2021, our cash balance was $116 $1 million, our accounts receivable balance was $8 $1 million and our notes receivable related to sale of pre boost we're $2 $5 million, our net working capital was $131 8 million.

Speaker 3: Now looking at the balance sheet. As of December 31, 2021, our cash balance was $116.1 million. Our accounts receivable balance was $8.1 million. And our notes receivable related to sale of pre-boost were $2.5 million. Our networking capital was $131.8 million at December 31, 2020. Compared to $136 million, it's September 30, 2021.

At December 31, 2020, compared to $136 million at September 30th 2021.

Speaker 3: Overall, we're delighted to see the growth in the USF-C2 prescription business. Then look forward to increasing sales in the global public sector business.

Overall, we're delighted to see the growth in the U S. F C. Two prescription business.

We look forward to increasing sales in the global public sector business.

Speaker 3: This revenue source, together with our strong balance sheet, continues to be the source of funds we use to invest in our promising pharmaceutical clinical development programs. As we continue to transform our company into a premium oncology biopharmaceutical company, seeking large market opportunities in breast and prostate cancers, as well as being our petunistic by joining the global efforts to find effective treatments for COVID-19. Now I'd like to turn the call back to Dr. Steinberg.

This revenue source together with our strong balance sheet continues to be the source of funds, we used to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium oncology biopharmaceutical company seeking large market opportunities in breast and prostate cancers.

As well as being opportunistic by joining the global efforts to find effective treatments for COVID-19, now I would like to turn the call back to Dr. Steiner.

Thank you Michelle in summary, we've had a highly productive financial first quarter, which has allowed us to significantly advance our clinical oncology programs. We have organized our FDA approved products into a sexual health division called <unk>. We're now.

Speaker 2: Thank you, Michelle. In summary, we've had a highly productive financial first quarter, which has allowed us to significantly advance our clinical oncology program.

Speaker 2: We've organized our FDA approved products into a sexual health division called URED. We're now entering our sixth year of growth in our FC2 U.X. prescription business.

Now entering our sixth year of growth in our <unk> U S prescription business for <unk>.

Speaker 2: We're executing on solid plans to expand partnerships and to launch our own direct-to-patient telemedicine into that pharmacy services portal.

Executing a solid plan to expand partnerships and to launch our own direct to patient telemedicine, the Internet pharmacy services portal with <unk>.

To commercially launch in tap fee also via our own direct to patient telemedicine and international services portal and we are partnering with good Rx to drive awareness and prescription conversion Boe.

Speaker 2: I plan to commercially launch a TAPB, also be our own director patient, telemedicine, and international services portal. And we have partnered with GoodRx to drive awareness and prescription conversion.

Speaker 2: Both programs should allow us to continue the robust growth of revenue from the URAB sexual

These programs should allow us to continue their robust growth.

Revenues in the U S sexual health Division, having these resources in place will allow us to continue to advance our deep late clinical stage breast cancer and prostate cancer programs as well as a phase III COVID-19 clinical study. We are quite pleased to have recently received fast track designation from FDA on two of the companies.

Speaker 2: Having these resources in place will allow us to continue to advance our deep lake clinical stage breast cancer and prostate cancer program.

Speaker 2: as well as a Phase III COVID-19 clinical study. We are quite pleased to have recently received fast track designations from FDA on two of the company's major drug development programs this past month.

Major drug development programs this past month.

Speaker 2: We anticipate a steady flow of important positive news with Erud over the next few months to one year.

Anticipate a steady flow of important positive news for <unk> over the next few months to one year, we're committed to driving shareholder value by developing commercializing novel medicines addressing significant unmet medical needs with a management addressed cancer prostate cancer and being opportunistic by developing <unk> so harsh.

Speaker 2: We're committed to driving shareholder value by developing, commercializing, novel medicines and dressing significant, unmet medical needs for the management of breast cancer and prostate cancer and being opportunistic by developing subvisibilance or hospitalized COVID-19 patients and high risk of acute respiratory stress syndrome and death.

Otherwise COVID-19 patients at high risk for acute respiratory distress syndrome in debt.

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

Speaker 2: With that, I'll now open the call to questions operator.

Yeah.

Thank you ladies and gentlemen at this time, we will begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone, we ask that you. Please pickup your handset before pressing the team to ensure that the best sound quality to withdraw your question. Please press Star then two.

Speaker 1: Thank you. Ladies and gentlemen, at this time we will begin the question and answer session to ask a question you may press star then one on your telephone keypad. If you're using your speaker phone, we ask that you please pick up your hand set before pressing the keys. In short, that's the best sound call.

Speaker 1: To withdraw your questions, please press star then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-answer the question two. Once again, let us star then one.

Please limit yourself to one question and one follow up if you have further questions you may reenter the question.

Once again that is star then one to join the questions here.

Speaker 1: The first question today comes from Brandon Folk with Canton, 6th Daryl. Please go ahead.

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

Speaker 4: Alright, thank you, Nick, questions and congratulations on all the prog-

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

Maybe just first on the Covid program, just given that's a near term catalyst.

Speaker 4: Maybe just first on the COVID program, just given that's the near term catalyst. How do you view the barhanging shifted or not on the COVID endpoints, especially around mortality? And then along those lines, do you think that's a secondary endpoint alone because support and approval here?

How do you view the ball, having shifted more not on the COVID-19 endpoints, especially around mortality and then along those lines do you think that the secondary endpoints alone could support an approval here.

Yes.

So the so just say that first part about mortality again, so what about the primary endpoint.

Speaker 2: So just say that first part about mortality again. So what about the primary endpoint?

Do you think.

Speaker 4: Do you think that agencies have shifted their view on endpoints, right, versus so if you don't, if we're not successful on mortality, do you think these secondary endpoints alone could still support an approval from the regulatory agencies? Yeah, yeah, got you guys.

Agencies have shifted their view on endpoints right versus so if you're doing if we're not successful on mortality.

Think of the secondary endpoints alone could still support and approval from the regulatory agencies.

Gotcha Gotcha gotcha. So so so the answer is I don't think theres switching at all on the primary endpoint I think that if you're seeing some recent activity and some people reporting results.

Speaker 2: So the answer is, I don't think they're switching at all on the primary endpoint. I think that if you've seen some recent activity and some people reporting results.

Speaker 2: And they're reporting themselves now on their primary end point. So at the beginning of any clinical trial, you state your primary end point. I'm not saying this to you, I'm just saying this for the people listening on the phone.

And the reported results now on their primary endpoints. So at the beginning of any clinical trial you state your primary endpoint I'm not saying this to you when this acreage for the people listening on the phone.

Speaker 2: You have to hit your primary endpoint. That defines success in a trial.

You have to you have to hit your primary endpoint I mean, thats what that define success in the trial and in mortality.

Speaker 2: And mortality, you know, deaths, I mean, that's about the hardest endpoint you can get. You can't fake a death and death, so we're trying to deal with in something as horrible as the pandemic.

Yes, I mean thats about the hardest endpoint you can get you can't fake adapt.

Endesa, we were trying to deal with in and something is as horrible as the pandemic.

Speaker 2: With that said, no, I do not think agencies are shifting on their desire to see an impact and mortality. And so I think we're good there. However, having said that, let me think one more comment. The other comment is, well, no, let me make this next time. Don't make the one I was up to make. So the answer to your question, there are key secondary endpoints that if you miss you may come back here. Because your gender even compared to your childmates. So also, for most Asian understandings, such as white empathy sometimes are due to anxiety, the

With that said no I do not think agencies are shifting on their on their desire to see an impact in mortality.

And so I think we're good there.

However, having said that and let me just make one more comment the other comment as well now let me make this next time, Joe maybe what I was asking so to.

To answer your question there are key secondary endpoints.

If you Miss on mortality and you get these other ones.

Speaker 2: There could be a discussion with FDA that these can stand on their own, but that's discussion with FDA. Now one thing it gives us comfort.

There could be a discussion with FDA.

That these can stand on their own but thats discussion with FDA and that one thing that gives us comfort.

As you know there.

Speaker 2: It says, you know, the space has gotten quite crowded in pre-hospitalized patients. So patients that are not in hospital, hospital. It's no longer in a medical need. You've got the fines to drive, the murk to out in others. And so in that setting, there are...

The space has gotten quote crowded and pre hospitalized patients or patients that are not in hospital hospitals, it's no longer an unmet medical need you've got you've got the Pfizer drug the Merck drug and others and so in that setting there are options.

Speaker 2: And in the hospitalized setting, when we're learning now the drug, in fact the FDA's even said they would have with the Omer Conferring, that some of these drugs, and a body drugs that are currently out there for people in the hospitalized setting should not be used.

And in the hospitalized setting.

<unk> now the <unk>.

In fact, the FDA even said.

<unk> variant that some of these drug antibody.

Antibody drugs that are currently out there for people in the hospital setting should not be used and so the fact that we got fast track designation by FDA.

Speaker 2: And so the fact that we got fast-tracked as a nation by FDA for hospitalized patients means it's still on that medical need. So in the event.

For hospitalized patients means is still unmet medical need so in the event that you have now.

Met medical need and you have the secondary endpoints are successful and you don't hear about mortality, that's a little different than the other options out there. So in that setting I think we have a lot of room to.

Speaker 2: and you have the secondary endpoint that's successful, and you don't hit on mortality, that's a little different than the other options out there. So in that setting, I think we have a lot of room to talk to FDA with the key secondary endpoints if that should do hit in a setting of an unmet medical need. And again, the unmetical need is not what we're saying. It's the fact that we just got FDA.

Talk to FDA.

With the key secondary endpoints, if that's what you hit in in a setting of an unmet medical need and again the medical need is not what we're saying is the fact that we just got FDA fast track designation means they'd also because remember they seek drugs in development and Macy drugs that are approved.

Speaker 2: Fast track designation means they also, because remember they see drugs in development and they see drugs that are approved. And so, you know, that gives us some...

So that gives us some comfort that.

Speaker 2: and we continue to work in a very important area of on that medical meet.

We continue to work in a very important area of unmet medical need.

Great. Thank you very much.

Thank you.

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

Speaker 1: The next question comes from Lea Land Garshall with Oppenheimer. Please go ahead.

Hey, good morning, Thank you for taking my questions.

Speaker 5: Hey, good morning. Thank you for taking my questions. I want to ask Mitch with respect to your development and breast cancer, being that the energy receptor is a, you know, a tumor suppressor in breast cancer. I want to know, you know, as you divide between those with the air expression, above 40 percent and below 40 percent.

Wanted to ask Mitch with with respect to your developments in breast cancer.

Being that the androgen receptor as it appears to be a tumor suppressor in.

In breast cancer.

Want to know as you divide between those with their expression above 40% and below 40%.

Speaker 5: How that breaks down with respect to the size of the fractions of the population with breast cancer with those levels of AR expression. Would the thinking be correct that more advanced ER positive or to negative breast cancer would be more enriched?

That breaks down with respect to the size of the fractions of the population with breast cancer with those levels of <unk> expression with the thinking would be correct.

<unk> against your positive <unk> negative breast cancer would be more enriched and the.

Speaker 5: In the AR given that those tumors are likely more resistant to therapy given, their expression of AR. And also want to ask with respect to intensity to the extent your market research may indicate what potential peak revenue might we expect for that product and given that you're telling that through the...

Given that those tumors are likely more resistant to therapy, given their expression who they are.

And also wanted to ask with respect to intensity.

To the extent you're your market research may indicate.

What potential peak revenue might we expect for the product and given that youre selling that through the <unk>.

Telemedicine channels.

Speaker 5: Telemedicine channels, you know, your own that you're setting up and others kind of give us a sense of what your margins may be on that product. Thank you.

You know your own that you are sitting up in others.

Give us a sense of what your margins may be on that product. Thank you.

So the first question basically is trying to understand the patient population of AAR.

Speaker 2: So the first question basically, is trying to understand the patient population of a are positivity. So the way to look at it is that that make the comment before that. You know men and women are born with the same machinery to make breast tissue. So why is itthat women develop breast tissue men?

Positivity so the way to look at it is that and I made this comment before that.

Men and women are born with the same machinery to make breast tissue. So why is that.

Women developed breast tissue man did not and the answer is the same machinery means is estrogen receptor and there is an answer receptor two in women estrogen no answer James Debello expressed in men, Andrew James and no estrogen.

Speaker 2: And the answer is the same machinery means as an estrogen receptor and there is an anzum receptor. So women estrogen and no anzum genes develop breasts and men, anzum genes and no estrogen, you don't get breast. So it's a tremendous, tumor suppressor, tremendous suppressor growth. So it's not surprising that after nine...

You don't get Brett So, it's a tremendous tumor suppressor tremendous suppressor growth. So it's not surprising that up to 90% of breast cancer tissue, we'll have Andrew receptor expression and so so now the question becomes is the question you're asking is the enrichment card in other words greater than 40%.

Speaker 2: A breast cancer tissue will have an angiome receptor expression.

Speaker 2: And so now the question becomes, and the question you're asking is the enrichment part, in other words, greater than 40% by less than 40%. So when you look at the numbers, and this is based on our phase two, so about 85% of breast cancers are gonna be ER positive, and of those 85% that are ER positive, about half of those will be ER positive greater than 40%.

By some 40% so when you put when you look at the numbers and this is based on our phase two so about 85% of breast cancers are going to be positives and of those 85% of the ER positive about half of those will be a positive greater than 40%.

Speaker 2: And so that's still a huge market and pretty prevalent target that we can have an opportunity to hit. So 50% would be AR less than 40 and 50% would be AR positive, greater than 40. And that's the reason why we have the subbizubular and tri.

And so so that's so it's still a huge market.

And pretty prevalent.

Target that we can have an opportunity to get so so 50% would be.

Less than 40, and 50, roughly 50% will be <unk> positive greater than 40, and that's the reason why we have distributed <unk> trial.

Speaker 2: the cystic trial because we know when we go out there and start looking for patients with metastatic AR positive breast cancer that happen and roughly half of them are going to be candid to a novosarm. And so we've got another active agent in breast cancer so why not allow that patient to have a choice of door number one or door number two. So door number one, if you're injured, receptor is greater than 40% expression. You get to go in the novosarm and if you're less than 40% you get to go in the sub-visit view so we get it you know to bite to the after.

And just to trial, because we know when we go out there and start looking for patients with metastatic HR positive breast cancer that happened in roughly half of them are going.

To be candidates Gray Novus arm until we've got another active agent in breast cancer, So why not.

Why not allowed that patient to have the choice of Jordan one of joining the two door number one antigen receptor is greater than 40% expression get to go into <unk>.

And if you're less than 40% of <unk>. So we get two bites of the Apple there with both of them are huge markets. The demographics are in our favor.

Speaker 2: with both some of the huge markets, the demographics are in our phases. And.

Interestingly.

Speaker 2: We did see an independent presentation at the Phantom Tony of breast cancer meeting this past December .

We did see we did we did see a independent presentation at the San Antonio breast cancer meeting this past December .

Speaker 2: that showed, and maybe this explains why the combination of a CDK46 inhibitor with a nobus arm could be interesting, because it turns out that this is not static, it's pretty dynamic, meaning the anterior receptor expression can change, and it can change with the actual treatment that you're getting. So what does Hanatonio's study showed?

That showed and maybe this explains why the combination of the CDK <unk> inhibitor with the Novus arm could be interesting because it turns out that this is not static it's pretty dynamic, meaning the Andrew receptor expression can change.

And it can change with the actual treatment that youre getting so with the San Antonio.

<unk> study showed.

Speaker 2: that maybe one of the reasons why the combination of a CDK46 inhibitor and novosarmy makes sense is it turns out that the CDK46 inhibitor actually induces the upregulation of the expression of antero receptor on breast cancer tissue. So another way of saying it is, if a novosarmy is trying to look for the antero receptor and the CDK46 inhibitor makes more antero receptor, that makes blame the potential synergy between the two.

Is that what may be one of the reasons why the combination of the CDK four six inhibitor notebooks, where it makes sense is it turns out that the CDK <unk> inhibitor actually induces the upregulation of the expression of antigen receptor on breast cancer tissue. So another way of saying it is <unk> and I was trying to look through the Andrew receptor.

And the CDK four six inhibitor makes more engine receptor that may explain the potential synergy between the two so it's not just what's their 50 50, but it could be that there's a bigger population to go after because CDK four six inhibitor will take somebody out of the 40% range, you've put up higher but that's for another day.

Speaker 2: So it's not just what's there in the 50-50, but it could be that there's a bigger population that go after because CDK-4 sticks in hip but it will take somebody out of the 40% range and put them higher. But that's for another day.

As it relates to <unk>, we have not given guidance, except to say that one.

Speaker 2: As it relates to intensity, we have not given guidance except to say that one, I mean, we think we're in some incredibly sure footing for a couple of reasons, okay, one, it really hasn't been a new BPH drug and many, many, many.

I mean, we think we are at.

I'm incredibly sure footing for a couple of reasons one it really hasn't been a new BPH drug in many many years and and so we would be the first new BPH drug and as you know all the BPH product.

Speaker 2: And so, you know, we would be the first new BPH drug. And as you know, all the BPH products.

Perhaps some sort of sexual side effects and finasteride in particular, which is very very popular with shrinks the prostate.

Speaker 2: have some sort of sexual side effect and finasteride in particular, which is very, very popular with shrink depositate. One of the number one side effects is has and one of the number one sexual side effects has an input.

One of the delivery side effects. It has one of the Netherlands sexual side effects with hazard incidents and and by combining finasteride tadalafil.

Speaker 2: And by combining finastery with the dallefil, and Tasty now becomes a, not just a new BPH method, it is a, they call it a new chemical entity in a sense that it's not substitutable. So you can substitute it, it stands on its own, which means it's branded. So we have a branded product that could have a branded price.

<unk> now becomes not just a new BPH medicine it is a.

They call it a new chemical entity in a sense that it's not substitutable.

You can't substitute it stands on its own which means as Brandon said, we had a branded product and it could have a branded price would.

Speaker 2: will be viewed as branded food by insurance companies, including Medicare. And so our pricing will be comparable to a branded product in the BPH space. And the fact that we don't have those sexual side effects of impotence in the combination compared to finasterly low really gives us an opportunity to convert.

It would be viewed as branded food by insurance companies, including Medicare and and so our pricing will be comparable to a.

To a branded product into BPH space and the fact that we don't have those sexual side effects of impetus in the combination compared to finasteride alone really gives us an opportunity to convert.

Establish patients who are having problems that's the low hanging fruit to us now to put this in perspective.

Speaker 2: you know, establish patients who are having problems. That's low hanging fruit. Two outs now, but this is perspective.

Speaker 2: The sales, I mean, the most recent, the curia data that I've seen, you know, this is still about a billion dollar market with 45 million prescriptions. And if you can convert, if you can convert, you know, one or two percent of those patients into a branded price, you're already starting to hit numbers that are well above $200 million.

The sales I mean, the most recent <unk> data that I've seen.

This is still about a $1 billion market with 45 million prescriptions and you can convert if you can convert one or 2% of those patients.

To a branded price you're already starting to hit numbers that are well above $200 million.

And that's with one or 2% of the total market being converted to a branded branded products. So we think there's real upside here, but we have not given any guidance that we just believe it's a big market that we have a differentiated product that it's a branded price.

Speaker 2: And that's with one or two percent of the total market being converted to the branded product.

Speaker 2: So we think, you know, there's real upside here, but we have not given any guidance. We just believe it's a big market. We have a differentiated product. It's a brand of price.

Speaker 2: And we're going to be taking advantage of telemedicine and not only telemedicine, but we're going to take advantage of good our excellent credible breath.

And we're going to be taking advantage of telemedicine and only tell medicine, but we can take advantage of good Rx incredible.

The breadth of being able to go out there and I mean.

Speaker 2: being able to go out there and I mean, a good or expands about three or $400 million a year, bringing people to their website.

Good or expense about three or $400 million a year, bringing people to the website.

Speaker 2: And it's not just consumers, it's also healthcare providers. And so the behavior to drive awareness and to focus primarily digitally.

And it's not just consumers its also health care providers, and so to be able to drive to drive awareness and to focus primarily digital.

Speaker 2: I argue, Rockler better turn digital advertising to those patients that are most in need, so you're efficient with your resources.

Digital.

Lastly, the return digital advertising to those patients that are most in need so youre efficiently your resources gives.

Speaker 2: Give the real I'm thinking we hit one or two percent. We get three percent. We hit four percent

It gives it a real uptick and we hit 1% to 2%, 3%, 4% it feels doable and so this could be a very important product to help us continue to drive the robust.

Speaker 2: It feels doable and so this could be a very important product to help us continue to drive the robust

Speaker 2: revenue that we're seeing from your app, by putting in Tatsy in with FC2, the two FDA approved products, just ensures that we can continue to maintain the largely paid for the critical development of our products.

Revenue that we're seeing from Europe .

And by putting in <unk> and with the FCC to the two FDA approved products just ensures that we can continue to maintain.

And largely pay for the clinical development of our products and do that particularly in an environment, where you know biotech looks like it's having the rough spell, but if you can look at our numbers and look at what we have in the bank. It looks like this model is working and so we can do that and if we can adjust how we how we.

Speaker 2: And do that particularly in an environment where, you know, you know, bi-tech looks like it's having a rough spell. But if you can look at our numbers and look at what we have in the bank, it looks like this model's work.

Speaker 2: And so we can adjust how we, what revenues come in, which is significant with our development program. It puts us in sure footing that our shareholders will see, these multi-billion dollar opportunity products without seeing big delusion that typically happens in biotech companies that are constantly raising money every six months to 12 months.

What revenues come in which is significant with our development program.

It put us ensure flooding that our shareholders will see this.

This multibillion opportunity multibillion dollar opportunity products without seeing a big dilution that typically happens in biotech companies are constantly raising money it'd be six months to 12 months.

Alright, thank you.

Speaker 1: The next question comes from Chris Powerton with Jeffery. Please go ahead.

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

Hi, good morning, and thanks for taking the questions really appreciate all the progress and the color. This morning Mitch.

Speaker 6: Hi, good morning and thanks for taking the questions. Really appreciate all the progress in the code this morning, Mitch. Maybe just two questions from me. One would be, can we get a little more color around the strategic decision to no longer pursue triple negative breast cancer with just competition in terms of like trodelvy and other options. Make that less.

Maybe just two questions for me one would be can we get a little more color around the strategic decision to no longer pursue triple negative breast cancer with <unk>.

Just competition in terms of like <unk> and other options to make that less.

Speaker 6: commercially viable at this point or I guess you know what is some of the other thinking around pausing that program um and then the second one would be

Commercially viable at this point or I guess, what is some of the other thinking around pausing that program.

And then the second one would be.

Ah <unk>.

Speaker 6: a Bemiciclib, you know, could you just give us some thoughts around the market share and why that's the right partner for a Nobus Army and what that might mean for the commercial opportunity. Let's say second line, her too positive. So thanks.

Could you just give us some thoughts around.

The market share and why that's the right partner for <unk> and what that might mean for the commercial opportunity, let's say second line her two positive so thanks.

Speaker 2: Yeah, two very very good questions. Okay, so let's start with the first one. The first one is purely a prioritization decision.

Two very very good questions. Okay. So let's start with the first one the first one is purely a prioritization decision. So we still believe the triple negative breast cancer is a major market. If you look at <unk> and they they.

Speaker 2: So we still believe the triple negative breast cancer is a major market.

Speaker 2: If you look at Trudelevi and they developed a compound for patients with metastatic triple magnetobress cancer that have failed to systemic hemotherapies, and that drug got bogged by Giliath, the $24 billion.

The compound for patients with metastatic triple negative breast cancer that have failed to systemic chemotherapies and that drug got bought by Gilead to $20 billion. So there's a market there and we have two oral therapies <unk> and we don't see.

Speaker 2: So there's a market there. And we have two oral therapies in Oversarm and Subisitbulein. And we don't see the Nitrapenia and all that other stuff and the Black Box stuff that you see with your delg.

The neutropenia and all the staff in the Black box stuff did you see the true Delta. So we think theres, a real opportunity, but we had to make a financial decision and the financial decision was that as I mentioned in the previous question answer is I don't know what's happening out there in the biotech space.

Speaker 2: So we think there's a real opportunity, but we have to make a financial decision.

Speaker 2: And the financial decision was that, as I mentioned in the previous question, answer is, I don't know what's happening out there in the biotech space. I think a lot of companies are going to be in trouble if they think the market's wide open for them to raise money.

A lot of companies are going to be in trouble or do you think the markets are wide open for them to raise money.

Speaker 2: So our thinking is we've got money in the bank. So that is the real reason why we need to be prudent with our resources and prioritize our resources. Because it's one thing to have no money in the bank and prioritize, nothing to have money in the bank and prioritize. And so if you look at our burn rate quote, the cash we use is small, OK? Why is it small? Because we've offset it with revenue coming from our sexual health business. So in order to...

So our thinking is we got money in the bank. So that is the real reason why we need to be prudent with our resources and prioritize our resources.

It's one thing to have no money in the bank and prioritize did nothing to have money in the bank and prioritize and so if you look at our burn rate quote to cash we use it small okay. Why is it small because we've offset it with revenue coming from our sexual health business. So in order to make sure.

Until I see things open up then we've got a lot going on we've got we've got three or four phase III phase II B and you've got the other ones that seem to be a phase III. So we said you know what.

Speaker 2: And till I see the things open up, then we've got a lot going on. We've got three or four phase threes, and we've got a phase two B, and you've got the other ones that soon can be a phase three. So we said, you know what, let's pause on triple negative breast cancer program. And that will put our spend on clinical development pretty much matching what we think will be coming in with our revenue and your rep business.

Let's pause on triple negative breast cancer program.

And that will put our spend on clinical development pretty much matching what we think will be coming in with our revenue from the direct business. So that we can wake up with significant resources in the bank at the end of the year and then and if it looks like it looks like we have more revenue coming in because of the Tad fee and then then we can.

Speaker 2: so that we can wake up with significant resources in the bank at the end of the year. And then if it looks like, you know, it looks like we have more revenue coming in because of the tax fee. And then we can make further decisions to move another trial forward. So we're blessed.

We can make further decisions to move another trial forward. So we're blessed in that we have new chemical entities that we own as a company.

Speaker 2: in that we have new chemical entities that we own as a company that can, and we'll have promise. But, you know, I think no one will get mad at us for seeing through some of these phase three programs, because we'll put it in a different,

And we'll have promise.

I think it's I think the only we will get mad at US we're seeing through some of these phase III programs.

It will put us in a different.

Market cap and also different financial setting. So then we can move still other program. So it is purely a prioritization play has nothing to do the market I think the market is huge opportunity, but we're dealing with a lot of huge opportunities until we just haven't prioritized.

Speaker 2: market cap and also different financial setting, so then we can look still other programs. So it's purely a prioritization play, has nothing to do with the market. I think the market is huge opportunity, but we're dealing with a lot of huge opportunities, and so we just have to prioritize.

As it relates to your second question on <unk>, Here's a very interesting point.

Speaker 2: As it relates to your second question on a Bemicyclic, here's a very interesting point.

Speaker 2: And why we thought really made sense as a part.

And why we thought really made sense as a as a partner so it turns out that the CDK ports. When we first when we first got about breast cancer people kept saying all of the field is crowded the field is crowded youre not going to be able to differentiate yourself and of course, that's not true because the Andrew receptors, we completely unexploited.

Speaker 2: So it turns out that the CDK force, when we first got involved with breast cancer.

Speaker 2: People kept saying, oh, the field was crowded, the field was crowded, and I could be able to differentiate yourself.

Speaker 2: Of course, that's not true because the engine receptors were completely unexploited and we thought by coming in with the engine receptors with a novosarm, the first drugable reel.

And we talked about coming in with the Andrew receptors with the Novus arm first drivable real.

Speaker 2: to avoid the man-groom receptor targeting and agonist that we had something that was new.

<unk> selective androgen receptor.

Targeting an agonist that we had something that was new but will change the landscape with the CDK <unk> inhibitor.

Speaker 2: We were changed to landscape with the CDK46 in Hibiscus.

So people on the call the TDK <unk> six inhibitor changed the landscape because it became the.

Speaker 2: People on the call, TDK46 is a hibiscus to landscape because it became the standard of care in first line breast cancer treatment if you're ER positive, HER2 negative. And that's the largest population of breast cancer patients.

The standard of care in first line breast cancer treatment, if you ER positive.

Two negative and Thats, the largest population of breast cancer patients and the company that owns that space right now is actually finding because Burma side SME palco cycling cichlids in combination with estrogen blocking agents is being used 80% of the time.

Speaker 2: And the company that owns that space right now is actually fine sir. Because a website, I assume, Palphos Cyclist, Sticklib, in combination with the Neston Blocking Age.

Speaker 2: is being used 80% of the time, 80% of the time, which means the other 20% is being filed over by Nefaratives as a Bible sick lived and Lily's a Bemicic lived, okay? And unfortunately, the fortunate part is when we'll see between 24 and 30 months of progression free survival, which is unbelievable, but they all are unfortunately progressed. And when they progress, there's really nothing.

80% of the time, which means you have the 20% is being fought over by Novartis. His wife was sick Lib and Lilly's <unk> okay.

And if you and unfortunately.

The fortunate part is when we will see between 2031.

Progression free survival, which is unbelievable, but <unk>.

Unfortunately progress and then they progressed there is really nothing.

Speaker 2: nothing approved and nothing, nothing approved, nothing in the NCCN, NCCN guidelines.

Nothing.

Proved and nothing nothing approved and nothing in the NCAA and <unk> guidelines.

Speaker 2: that follows a CDK46 inhibitors. So this space is wide open. So.

Followed the CDK <unk> inhibitors of this space is wide open so it makes sense.

Speaker 2: that go into second line with an agent that's shown in pre-clinical models that's a combination of an Elvis R plus a CDK 4-6 inhibitor has synergized.

They go into second line with an agent that has shown in preclinical models that the combination of <unk> plus a CDK <unk> inhibitor.

Had synergy.

And that that synergy is probably related to the fact that the CDK <unk> inhibitors increasingly androgen receptor, making a note the storm work better and so it's not just you just adding two drugs together CMS. It was back then it could really be a significant synergistic effect and if thats. The case you need the CDK <unk> inhibitor, but what's it better.

Speaker 2: And that that synergy is probably related to the fact that the CDK-46 inhibitors increasing the angiorniscepter, making a no-bissarm work better. And so it's not just you're just adding two drugs together to see an active effect, but it could really be a significant synergistic effect. And as that's the case, you need a CDK-46 inhibitor. So what's a better situation to get a CDK-46 inhibitor that is not being used at 80% of patients at first one?

<unk> to get a CDK <unk> inhibitor that is not being used at that 80% of patients in first line.

That means of 80% of patients in first line using tableau they need a new one.

Speaker 2: That means that 80% of patients in first-line are using a cowbo. They need a new one.

Speaker 2: And so that new one could be a bit of a stateless. So we're really positioning an oversize.

And so that new one could be devastated so we're really positioning in overtime.

Speaker 2: I hope you grab that 80% of patients that fail power bill plus an extra walking agent by now. Now they're gonna be looking for something else. Maybe that's something else, it'll be a MSI could and a novosar.

I hope to grab that 80% of patients that fail parallel plus an estrogen blocking agent by now now that you'd be looking for something else and maybe it may be that something else will be <unk> and <unk>.

And so it was very strategic to two partnered with Lilly on this one because their agent which is a very good agent and they came later to the game could be could be in combination with <unk>.

Speaker 2: And so it was a very strategic to partner with Lily on this one because they're agent, which is a very good agent and they came later to the game, could be in combination with a nervous arm. They go to a combination after patient failed first one.

They go to a combination of assets after patients have failed first line.

That's that makes a lot of sense and I really appreciate it. Thank you Mitch.

Speaker 6: That makes a lot of sense and I really appreciate it. Thank you Mitch.

Thank you.

The next question kind of Sandy Chen with H C. Wainwright. Please go ahead.

Speaker 1: The next question comes from you, 10 with HC, waiting right. Please go ahead.

Thank you for taking my questions. My first question is could you tell us whether it would be.

Speaker 7: Thank you for taking my questions. My first question is, could you tell us whether the

Speaker 7: In Roman's feed for the Art Test study and the Varatite study is meeting expectations.

Enrollment speed for the test study and the porosity study.

Is meeting your expectation.

Yes. So the answer your first question the our test in Nebraska studies of both of them are enrolling on track.

Speaker 2: Yes, the answer first question is the artist and the brass whose studies are on both the moon rolling.

Got it thanks and.

Speaker 7: And could you tell us what you expect, a current expectation for revenue from and catafine for this fiscal year?

Could you tell us.

What do you expect to occur one expectation for revenue from.

Testing for this fiscal year.

Yeah. So thank you for the question so I answered the so somebody else I think Leland Leland.

Speaker 2: Yeah. So thank you for the question. So I answered the, so somebody else, I think, we went, we went, also asked that same question. We have not given guidance as to what we think the revenue will be. But we have said this a couple things. We said that there are 45 million.

Also asked that same question, we have not given guidance.

As to what we think the revenue will be but we have said this a couple of things we said that there are $45 million.

Speaker 2: prescriptions filled each year with BPH. We know that almost all BPH products are going to cause some sort of sexual dysfunction. We know that the finasteride products have the impidence. We know the combination of finasteride and tithaicophiluses and tathy does not, we do not see the impidence.

Prescriptions filled each year with BPH, we know that almost all BPH products are going to cause some sort of sexual dysfunction. We know that the finasteride products have incidents we know the combination finasteride into Dallas, where we just didn't tap the debt that we did not see the incidents.

Speaker 2: And so we think that a real opportunity to convert these patients to the combination therapy and task-week. But we also said that the BPH market looks like it's about a billion dollars. And about 2 to 3 percent of that is branded products, which make up about, you know, $400 million of that $1 billion.

So we think there's a real opportunity to convert.

These patients to the combination therapy in tap fee, but we also said that the BPH market looks like it's about $1 billion and.

And about 2% to 3% of that branded products, which make up about.

Three of $400 million of that $1 billion.

Speaker 2: And so if we were able to convert one to two percent

So if we were able to convert one of 2%.

Speaker 2: of that market towards fantastic, it could be big.

Of that market towards <unk>, it could be big.

Okay.

Speaker 7: And regarding the triple negative risk cancer program, do you think there's a chance you might reactivate the program in the future and how soon make that?

And regarding the trip.

Triple negative breast cancer program do you think there is a chance you might reactivate the program in the future and how soon.

Yes, so sure.

Speaker 2: Yeah, so as it relates to commitment and reactivating as the answer is absolutely recommitted to reactivating.

As it relates to commitment and reactivating. It the answer is absolutely. We are committed to reactivate again, so it's purely a timing and prioritization of resources under the current.

Speaker 2: So it's purely a timing and part of the station of resources under the current market conditions.

Market conditions, and the fact that we have so many phase III going on particularly COVID-19 that we felt that for an organization of our size and we probably should pause on that not spend that money and keep our money spend.

Speaker 2: And the fact that we have so many phase threes going on to particularly COVID-19, that we felt that, you know, for an organization our size, that we probably should pause on that, not spend that money.

Speaker 2: and keep our money spend very close to our revenue, or not just revenue, the cash coming off, the sexual health business, so that we can, you know, we go another year with, you know, we can press our money in the bank.

Very close to our revenue.

Not just revenue the cash coming off the sexual health business. So that we can go another year with impressive money in the bank and so that was the thinking.

Speaker 2: And so that was the thinking, but you know, things can change. It's COVID-19 hit.

But things can change as COVID-19 hit and.

Speaker 2: And, or if, you know, we find ourselves in a situation that in TASC and F2 continue to generate 30 to 40% growth in the year after year, because we're going to our six year and we see something like that, then it'll be pretty easy. I mean, the protocol's written, you know, it's ready to go, we have the drugs, it's ready to go. So we can pretty quickly get it back on track.

Or if we find ourselves in a situation that in tassie and FCT continuing to generate 30% to 40% growth in.

In the past.

Year after year, because we're going into our six year and we see something like that then it would be pretty easy I mean, the protocol is written.

It's ready to go we have the drug is ready to go. So we can pretty quickly get it back on track, but this is purely a prioritization of resources to keep us keep our spend within our cash coming off as much as possible of the cash coming off the revenue base business.

Speaker 2: But this is purely a prioritization of resources to keep our spend within our cash coming off, as much as possible, all the cash coming off the revenue basis.

Got it got it.

Speaker 7: And lastly, are there any parties that are interested in purchasing the UREF Setra Files division from the room?

Lastly are there any part of your start are interested in purchasing the <unk> sector.

<unk> division from the room.

Speaker 2: So the answer is, the answer is, are there any parties into purchasing it? So the answer is, yeah, there are parties interested in purchasing it. The real question for us is making sure that it's the right value for our shareholders and to make sure that we take advantage of, you know, I mean, might not be generating a lot of money for us.

So the answer is the answer is.

Any parties.

Seeing it so the answer is yeah. There are parties interested in purchasing at the real question for US is making sure that it's the right value for our shareholders and to make sure that we take advantage of.

I mean, right now it's generating a lot of money for us and it feels good to have that revenue base right. Now we think there are things that we can do to make the sexual health division look even more attractive so that we can.

Speaker 2: And it feels good to have that revenue base right now. We think there are things that we can do to make the sexual health division look even more attractive so that we can, you know, even more value.

Even more valuable.

Speaker 2: And that is right now going from a women's health company to a sexual health company instead of having a single product, now we have two products. And instead of using other telemedicine partners, we're going to become a telemedicine energy ourselves.

And that is by now gone from a women's health company to a sexual health company.

Having a single product that we have two products in.

And instead of using other telemedicine partners, we're going to become a tele medicine entergy ourselves.

And so all of those things will add more value to the base business and while we are enjoying the cash flow coming from the base business at the same time. We are also increasing the value of the base business. So that when we're ready we will have some more opportunities more options.

Speaker 2: And so all of those things will add more value to the base business. And while we're enjoying the cash flow coming from the base business, at the same time, we're also increasing the value of the base business so that when we're ready, we'll have some more opportunities, more options to advertise.

We define the ties.

Great. Thank you.

The next question comes from Kumar <unk> with.

Speaker 1: Next question comes from Kumar Rejay with Bupalian Capital Market. Please go ahead.

With Brookline capital markets. Please go ahead.

For taking my questions and also congratulations on all the progress.

Speaker 8: for taking my questions and also congratulations on all the progress. First, with regard to COVID-19 what are you seeing there? Is it fair to estimate that your close completion of enrollment given that you are planning to release date on the first half?

First with regard to COVID-19.

What are you seeing there.

Is it fair to estimate that you are close to completion of enrollment given that.

You are planning to release data in the first half.

So make sure of the question as to COVID-19 study and the question is.

Speaker 2: So make sure the question is, it's a COVID-19 study and the question is,

Speaker 2: It's my phone breaking in and out, so I powered death.

St.

That's my phone breaking in and out so I apologize.

Speaker 8: in terms of hospitalization, what kind of trend for you?

In terms of hospitalization, what kind of training.

Yes.

In terms of how can you give us guidance.

Speaker 8: and given that, yeah given that you are planning date and the first half is it fair to expect that you are close to completion of enrollment.

Yes, given that you are planning data in the first half is it fair to expect that you are close to completion of enrollment.

Speaker 2: So the good news is that we're on track, as I said in my formal comments, we're on track to have data, clinical trial results for the study in the first half of this year. I will tell you that the hospitalization,

I would just say, yes. So so the good news is that we are.

We're on track.

As I said in my formal comments, we're on track to have data clinical trial results of this study in the first half of this year.

I will tell you that.

The hospitalizations.

Speaker 2: have increased tremendously across the world, fortunately.

<unk> increased tremendously across the world. Unfortunately.

Speaker 2: for the patients because we don't, of course, you don't want to see that, the best what's happening. As you know, hospitalizations are there, lag behind new cases.

Towards the patient because we don't of course, we don't want to see that that's what's happening as you know hospitalizations or death lagged behind new cases, and what's interesting is what we're seeing is that the cases that make it to the hospital and.

Speaker 2: And what's interesting is what we're seeing is that the cases that make it to the hospital and, you know, those ICU type patients, you know, once they're on that slippery slope, we're finding

Those ICU type patients once they are on that slippery slope refining visits to death rates in patients who are at risk, especially those with acute respiratory distress syndrome is similar to the other variance.

Speaker 2: And it gets rates in patients that are risked, especially those with risk for acute risk for distress of them, similar to the other variants.

Speaker 2: It's just that the milders stop, you know, you know, you know, you see a lot of it, but the ones that finally make it to the hospital, really is a problem.

Just that the mildest Scott.

You see a lot of it but the ones that finally make it to the hospital was a problem.

Speaker 2: If you know there's about 140,000 hospitalizations degree.

It was about 140000, new hospitalizations a week.

Speaker 2: And so it's a really, I mean, the highest ever in the pandemic. It's not it's harder than I'll get three ways.

And so it's the highest ever in the pandemic it is higher than all the other three waves. So with that said it has put us in solid footing to to enroll.

Speaker 2: So with that said, it's put us in solid footing to enroll and to get the data in the first half of the year. So all I'm gonna tell you is that we believe that we will have a clinical data in the first half of the year to in patients who are hospitalized, which as you know now.

And to get the data in the first half of the year. So I'll tell you is that we believe that we will have clinical data in the first half and half of the year to two two in patients who are hospitalized, which as you know now.

Theres no theres no.

Speaker 2: There's no medicine available and the fast track status from the FDA is further confirmation that's around that medical need. And if we can fill that on that medical need with an oral agent, that's not an infusion. That doesn't require cold.

Medicine available and.

And the fast track status from the FDA.

Further confirmation that it's an unmet medical need and if we can fill that unmet medical need with an oral agent that's not not a infusion.

That doesn't require a cold storage.

Speaker 2: so that you can put in backpacks and get it to the motorings of the world. It's hospital-based as opposed to pharmacy-based so that you can quickly get it mobilizing to hospitals.

So that you can put it in backpacks and get it to remote areas of the world.

Hospital based as opposed to pharmacy base. So you can quickly get it mobilize into hospitals as opposed to trying to get a JV pharmacy in the country. So from a distribution standpoint.

Speaker 2: as opposed to trying to get it to every pharmacy, you know, in the country. So from the distribution standpoint, you know, it will be a lot easier. So I think we're kind of in the right space, right, right time.

It will be a lot easier so I think what kind of the white space right.

Right time.

Speaker 2: And the we're on track to provide data in the first half.

But we are on track to provide data in the first half of this year.

Okay and with regard to <unk>.

Speaker 8: Okay, and with regard to Arabos Farm and Sabizabullin, what kind of interactions have you had with EMA? And the ongoing trials be leveraged for approval in...

And in both pharma and <unk>.

What kind of interactions have you had with <unk>.

And the kind of the ongoing brands be liquidated for approval.

Yes.

So as it relates to the EMA.

Speaker 2: So as related to the EMA, we have all our interactions have been with FDA.

We have all our interactions have been with FTA.

Speaker 2: Our interaction with EMA for the International Studies are that they should be part of the appropriate paperwork so that we can do the studies in Europe which we have.

Our interaction with EMA for the international study that they make sure that we filed the appropriate paperwork. So that we can do the studies in Europe , which we have.

Speaker 2: But we have not we have not gone to EMA to seek scientific advice or anything of that sort mainly because we know our studies are pretty straightforward and but we will as we as we get the enrollment going and and you know we'll go back to EMA and go back to Japan but at this point now you know our thinking is focus in the US

But we have not we have not gone to EMA to seek scientific advisory or anything of that sort.

Mainly because.

Our studies are pretty straightforward.

But we will as we.

As we get the enrollment going in and.

We will go back to EMEA and go back to Japan, but at this point now.

Our thinking is focused in the U S.

Speaker 2: And when we partner the opportunity, the partner will have to wear it all, an ability to do Japan and Europe at the same time. But we're successful in the US, which is the premium market will be...

And when we pardon me the opportunity to partner will have the wherewithal and the ability to do Japan and Europe at the same time, but we are successful in the U S, which is the premium market.

We'll be in good shape.

Speaker 8: Okay, finally with regard to COVID-19 external funding, use the funding mostly for manufacturing.

Finally, with regard to COVID-19 external funding.

He is the funding mostly potter manufacturing.

Yes, and so as you know, we're essentially almost done with the clinical study, where we're going to need the most help and as you can see is going to be in the procurement and distribution and as Berke I can't remember the number but it was a big number 1 billion something in size, you got $1 billion something to obscure again.

Speaker 2: Yes. And so, as you know, we're essentially almost done with the clinical study, where we're going to need the most help. And as you can see, it's going to be in procurement and distribution. And as you can, you know, Murk got, I can't remember the number of those, a big number of billions, something, and five of those billions, something for procurement. So, you know, there's no risk to the government. Once you get an EUA and emerge to use authorization, you know, then the issue becomes, you know, the government needs to buy and get it out there.

So there's no risk to the government once you get an EUA emergency use authorization.

Then the issue becomes the government need to buy it and get it out there.

Speaker 2: And so we were successful in our phase three, and we have an EUA. We feel pretty strongly, and we believe that we should be able to get external funding to help us with scale up and distribution. And so that's been our focus. Interestingly, after the wave of vaccines and antibody drugs.

And so we were successful.

In our phase III, and we Havent EUA, we feel pretty strongly.

We believe that we should be able to get external funding to help us with the scale up in distribution.

And so that's been our focus.

Interestingly after the wave of vaccines and antibody drugs.

Speaker 2: You know, Barter has just gone silent in terms of funding these opportunities, but they're very, very active once you've shown efficacy and safety. And so you can take advantage of that window.

BARDA has just gone silent in terms of funding of these opportunities.

But we're very very active once you've shown.

Efficacy and safety and so we can take advantage of that window.

Thanks, so much.

Thank you.

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

Speaker 1: Ladies and gentlemen, this concludes our question and answer session. I would now like to turn the conference back over to Dr. Mitchell Steiner for any closing

Speaker 2: Thank you everybody. I appreciate you joining us on today's call. I look forward to updating all of you in our progress and our next Investors call. Thank you again.

Thank you everybody 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 again.

Speaker 1: The digital replay of the conference call will be available beginning approximately new Eastern Standard Time. February 9th by dialing 1-877-344-7529 in the US and 1-412-317-0088 International.

A replay of the conference call will be available beginning approximately noon eastern standard time.

February 9th by dialing one eight Kevin Kevin 344, 75 to nine in the U S and one for one to maybe 178 internationally.

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