Q4 2021 Veru Inc Earnings Call

[music].

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

Operator: Good morning, ladies and gentlemen, and welcome to the Veru Incorporated Investor Conference Call. All participants will be in listen-only mode.

All participants will be in listen only mode should you need assistance. Please signal conference specialist by pressing the star followed by zero.

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

After this mornings discussion there'll be an opportunity to ask questions. Please note. This event is being recorded and I would like to turn the conference call over to Mr. Sam Fisch, They ruin corporate 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.

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

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

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

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

<unk>, Chairman CEO and president.

Good morning with me on this morning's call are Michele Greco the CFO and CEO, Dr. Gary Barnett to Chief Scientific Officer, Michael purpose Executive Vice President General Counsel and corporate strategy and same fish executive director of Investor Relations and corporate communications. Thank you for joining our call.

Mitchell Steiner: With me on this morning's call are Michele Greco, the CFO and CAO, Dr. Gary Barnett, the Chief Scientific Officer, Michael Purvis, Executive Vice President, General Counsel on Corporate Strategy, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Fiscal year 2021 was an exciting and very productive year for Veru. We have successfully transformed our company into a late stage biopharmaceutical company. We're developing novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer.

Fiscal year 2021 was an exciting and very productive year for beer.

We have successfully transformed our company into a late stage.

Apologies biopharmaceutical company, we are developing novel medicines for the management of two of the most prevalent cancers breast cancer and prostate cancer, one of our anti cancer drugs to visit viewing has dual antiviral and anti inflammatory effects and is also being developed for the potential treatment of hospitalized COVID-19 page.

Mitchell Steiner: One of our anti-cancer drugs, ibuprofen, has dual anti-viral and anti-inflammatory effects and 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.

<unk> at high risk for acute respiratory distress syndrome, which remains a global dire unmet medical needs. The company has a commercial sexual health division, which includes the drug candidates in taxi, formerly referred to as tests at a new.

Mitchell Steiner: The company has a commercial sexual health division, which includes a drug candidate in TADFI, formerly referred to as TADFIN, a new treatment for benign prostatic hyperplasia, and a commercial product, the FC2 female condom, an internal condom, an FDA-approved product with dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. Revenue from the Sexual Health Division is being used to largely fund the clinical development of our late-stage drug candidate assets which aim to address multi-billion dollar premium market opportunities this morning.

It's a benign prostatic hyperplasia and the commercial product the <unk> female condom.

Turtle condom and FDA approved product for the dual protection against unplanned pregnancy, and the transmission of sexually transmitted infections wherever you from the sexual health Division.

It's being used to largely fund the clinical development of our late stage drug candidate assets, which aimed to address multibillion dollar premium market opportunities.

Morning, we will discuss <unk> business strategy.

Mitchell Steiner: We will discuss Veru's business strategy, the clinical development of our drug pipeline, and the commercialization of our product, which will also provide financial highlights for the fourth fiscal quarter and record fiscal year 2021. As you are aware, we're still in the middle of the COVID-19 pandemic with no end in sight. Countries in Europe and other continents are now back in lockdown.

Clinical development of our drug pipeline and the commercialization of our products. We will also provide financial highlights for the fourth fiscal quarter and record fiscal year 2021.

As you're aware.

We're still in the middle of the COVID-19 pandemic with no end in sight.

Countries in Europe, and other continents are now back in Lockdown.

Tenders for disease control and prevention have recently reported that the U S. COVID-19 U S. COVID-19 in the U S. COVID-19 has killed 377883 people in 2020 and Infor.

Mitchell Steiner: The Centers for Disease Control and Prevention recently reported that the U.S. COVID-19 in the U.S. COVID-19 killed 377,883 people in 2020 and 401,117 people in 2021, although the year is not yet over. A new, potentially more troubling COVID-19 variant called Omicron has emerged in South Africa, and a case has just been confirmed in California. This new virus variant appears to have mutations that make it more contagious and may infect people that have been previously vaccinated, rendering the current choices of COVID-19 vaccines and antibody drugs less effective. The mechanism of drug action of sibizibulin is that it disrupts the microtubule intracellular transport of the coronavirus.

Four and 401117 people in 2021.

The year is not yet over.

A new potentially more traveling COVID-19 variant called overcrowded has emerged in South Africa and a case just has been confirmed in California. This new virus variant appears to have mutations that make it more contagious. It may in fact people that had been previously vaccinated rendering to current choices of COVID-19.

It seems an antibody drugs less effective.

The mechanism of drug action of CBS viewer is it disrupts the microtubule intracellular transported the Corona virus practice that will still be required by new variants or strange, if COVID-19, including albacore and to cause infection.

Mitchell Steiner: A process that will still be required by new variants or strains of COVID-19, including Omicron, to cause infection. Meanwhile, there have been recent developments evaluating the Merck drug and the Pfizer drug. Paxilovan for the treatment of unhospitalized patients with mild to moderate COVID-19 who are at relatively low risk of dying. Sabiz Abulan, on the other hand, is being developed for hospitalized patients who have a high risk of death, in our positive phase 2 clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome.

Well there have been recent developments evaluating the Merck drug multi pyramid pyramid and the.

Pfizer drugs.

In fact, the Logan acts of Logan for the treatment of hospitalized patients with mild to moderate COVID-19, who are who are relatively low risk of dying.

<unk> in contrast is being developed for hospitalized patients with high risk of death.

And our positive phase II clinical study in hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. So basically on treatment resulted in an 82% relative reduction in deaths compared to placebo.

Mitchell Steiner: This visible treatment resulted in an 82% relative reduction in deaths compared to placebo in our phase two clinical study. If these results are replicated to any significant degree in our global phase three clinical study, we believe subisibulin would fill a significant unmet medical need for hospitalized patients. In May of 2021, we initiated the Phase 3 clinical study, which is a double-blind, multi-center, multi-national, and randomized 2-to-1 placebo-controlled study, evaluating daily oral doses of 9 milligrams of ibuprofen for up to 21 days versus placebo standard of care in 300 hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome.

Our phase II clinical studies.

Ah replicated results are replicated to any significant degree in our global phase III clinical study, we believes the basic dealing with Phil and that's a significant unmet medical need for hospitalized patients.

In May of 2021, we initiated the phase III clinical study, which is a double blind multicenter multinational randomized two to one placebo controlled study evaluating daily oral doses 90 milligram <unk> up to 21 days.

Versus placebo or standard of care in 300 hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome, 200 subjects will be treated with two basic bulent.

Mitchell Steiner: 200 subjects will be treated with subizabuline, and 100 subjects will receive placebo. The primary efficacy endpoint will be the proportion of patients who die during the study up to day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in the ICU, the WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral loads. The study is being conducted in the US, Brazil, Argentina, Mexico, Colombia, and Bulgaria.

<unk> hundred subjects will receive placebo.

The primary efficacy endpoint will be the proportion of patients who die on study up to date 60 secondary endpoints will include the proportion of patients without respiratory failure days in the ICU W. H O ordinal scale for clinical improvement change from baseline days on mechanical ventilation days in a hospital.

Firewall load.

Studies being conducted in the U S.

<unk>, Argentina, Mexico, Colombia in Bulgaria, The company has sufficient clinical drug supply on hand to complete this phase III clinical study.

Mitchell Steiner: The company has sufficient clinical drug supply on hand to complete this Phase III clinical study. It helps fund the commercial drug to supply the needs of the U.S. population, assuming confirmatory positive clinical results and FDA approval. We are seeking funding from BARDA and other agencies.

To help fund the commercial drug.

To supply the needs of the U S population, assuming confirmatory positive clinical results in F. T approval, we are seeking funding from BARDA and other agencies the company anticipates, having results for the phase III clinical trial in the first half of calendar year 2022.

Mitchell Steiner: The company anticipates having results for the Phase III clinical trial in the first half of calendar year 2022. As for our Oncology Drug Portfolio, this was the year we initiated our expansive Metastatic Breast Cancer Program with two of our drug candidates, Inobisarm, and Sabizibulin. We are developing treatments against both hormone-receptor positive and triple negative metastatic breast cancer. Anobis Arm is an oral-selective androgen receptor-targeted agonist that has shown efficacy in phase two studies in a heavily pre-treated hormone-receptor positive metastatic breast cancer patient population with an excellent safety profile without causing unwanted masculinizing adverse side effects.

As for our oncology drug portfolio. This was the year, we initiated our expansive metastatic breast cancer program with two of our drug candidates and Nobu star as the visit Bulent, we are developing treatments against both hormone receptor positive and triple negative metastatic breast cancers.

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

<unk> represents the first new and novel, Andrew Crean therapeutic approach in breast cancer and decades are.

Mitchell Steiner: Novosarm represents the first new and novel endocrine therapeutic approach to breast cancer in decades. Our second drug candidate, sibizibulin, is an oral cytoskeleton disruptor that targets unique binding sites in cross-linked microtubules, a well-validated cancer target resulting in promising efficacy and a favorable safety profile without clinically relevant neurotoxicity, neutropenia, or alopecia.

Our second drug candidate <unk> is an oral side the skeleton disruptor that targets unique binding sites in cross links microtubules.

Mitchell Steiner: Furthermore, chronic oral daily administration of sibizibulin is feasible. Our clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in both hormone receptor positive and triple negative 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 nuclei staining or expression levels in their breast cancer tissue for patients with greater than or equal to 40% androgen receptor expression.

That would be the cancer target, resulting in promising efficacy and a favorable safety profile.

Without clinically well within neurotoxicity.

Neutropenia or alopecia. Furthermore, chronic oral daily administration of <unk> is feasible.

Our clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in both hormone receptor positive and triple negative metastatic breast cancer.

And 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 or expression levels in the breast cancer tissue.

Patients with greater than or equal to 40% androgen receptor expression.

We're actively enrolling in a global phase III Artest registration clinical study to evaluate and notebooks are on monotherapy with a third line treatment of <unk>.

Mitchell Steiner: We are actively enrolling in a global phase 3 R-Test registration clinical study to evaluate novoSARM monotherapy for the third-line treatment of androgen receptor positive, estrogen receptor positive, and human epidermal growth factor 2 negative metastatic breast cancer. NovoSARM targets the antireceptor, which has tumor suppressor activity in AR-positive, ER-positive, HER2-negative metastatic breast cancer without causing unwanted masculinizing side effects NovoSARM has extensive non-clinical and clinical experience, having been evaluated in 25 separate clinical studies in over 2,000 patients, including three Phase II clinical studies in advanced breast cancer involving more than 250 patients. This means we have a very good understanding of a favorable safety profile with an oversight.

Androgen receptor positive estrogen receptor positive and human epidermal growth factor too negative metastatic breast cancer.

No. The showroom targets, you Andrew receptors, which has it tumor suppressor activity in ER positive <unk> positive her two negative metastatic breast cancer without causing unwanted masculinizing side effects. No shahram has extensive non clinical and clinical experience hasn't been evaluated in 25 separate clinical studies in over 2000.

Patients, including three phase III clinical studies and advanced breast cancer involving more than 250 patients. This means we have a very good understanding of the favorable safety profile with Adobe sign.

As for the ASP of efficacy there were two phase III clinical studies conducted in women with ER positive <unk> positive her two negative metastatic breast cancer, where nobu storm demonstrated significant antitumor activity in heavily pretreated cohorts.

Mitchell Steiner: As for efficacy, there were two Phase II clinical studies conducted in women with AR-positive, ER-positive, HER2-negative metastatic breast cancer, where Inovasarm demonstrated significant anti-tumor activity in heavily pretreated cohorts that developed tumor progression after receiving estrogen-blocking agents, chemotherapy, and or a CDK4-6 inhibitor, and again in this population, Inovasarm was well-tolerated with a favorable safety profile. In October of this year, we initiated the Phase III Multicenter International Open-Label Randomized One-to-One, or TEST, registration clinical trial to evaluate the efficacy and safety of Inovasarm monotherapy versus an active comparative, either Examestane plus or minus, Epirolimus, or CIRM, for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer in approximately 210 patients with greater than or equal to 80% AR expression in the breast cancer tissue after receiving a non-steroidal limitase inhibitor, Fulvestrin, and a CDK4-6 inhibitor.

Two progression after receiving estrogen blocking agents chemotherapy and or CDK four six inhibitor and again in this population and open shop was well tolerated with a favorable safety profile.

In October of this year, we initiated the phase III Multicenter International open label randomized one to one our test registration clinical trial to evaluate the efficacy and safety pin oberstar and violent therapy versus an active comparator, either exemestane plus or minus that rely on this or <unk> for the treatment of a pause.

Your positive <unk> negative metastatic breast cancer.

Proximately 210 patients with greater than equal to 40% <unk> expression in the breast cancer tissue after receiving a non story with limitations editor for best way and the CDK four and six inhibitor.

In patients with less than 40% expression, we have a planned phase II B study to evaluate <unk> in monotherapy with a third line treatment of your positive to negative metastatic breast cancer.

Mitchell Steiner: In patients with less than 40% AR expression, we have a planned Phase 2B study to evaluate subisapulin monotherapy for the third-line treatment of ER-positive, HER2-negative metastatic breast cancer. Phase 2B clinical study will be an open-label, multi-sensor, and randomized one-to-one study evaluating the efficacy and safety to visible and 32 milligrams monotherapy versus active comparative, either examestane plus or minus at Relimus or CIRM for the treatment of ER-positive, HER2-negative metastatic breast cancer in approximately 200 patients with less than 40% AR expression in the breast cancer tissue after receiving a non-steroidal aromatase inhibitor for vestibule and a CDK46 inhibitor.

As to be clinical study will be an open label multicenter randomized one to one study evaluating the efficacy and safety of <unk> 32 milligrams monotherapy versus active comparative either exemestane plus or minus separate alignments or serve the treatment of your positive <unk> negative metastatic breast cancer.

Approximately 200 patients less than 40% <unk> expression in the breast cancer tissue after receiving a non steroidal aromatase inhibitor for best with CDK four six the neighborhood.

Just received the safe to proceed letter from the FDA. This month and the Phase <unk> study is expected to commence in calendar Q1 2022.

Mitchell Steiner: He just received the Safe to Proceed letter from the FDA this month, and the Phase 2B study is expected to commence in calendar Q1 2022. We're also moving the ovus arm earlier in the treatment sequence to the second line treatment of AR positive, ER positive, HER2 negative, metastatic breast cancer by targeting patients with AR breast cancer expression greater than or equal to 40% in the Phase 3 Enabler 2 clinical study. The CDK-46 inhibitor and an estrogen-blocking agent combination has become the first-line therapy for patients with ER-positive or 2-negative advanced breast cancer.

We're also moving and open so I'm earlier in the treatment sequence to the second line treatment of <unk>.

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

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

Fortunately almost all patients will develop drug resistance and eventually developed breast cancer progression.

Mitchell Steiner: Fortunately, almost all patients will develop drug resistance and eventually develop breast cancer progression, based on the positive phase two clinical data and the preclinical data supporting the use of inobu sarin in combination with a CDK4-6 inhibitor in patients who have CDK4-6 inhibitor in estrogen-blocking agent resistance, plan to conduct a phase three, multi-sensor, open-label, randomized one-to-one, active control registration clinical study named Enabler to evaluate the efficacy and safety of Inovasan plus Abema Cyclo-Combination Therapy versus an alternative estrogen blocking agent in subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer, with failed first-line therapy with palvocycline, which is a CDK4-6 inhibitor, plus an estrogen blocking agent, and have greater than or equal to 40% error expression in their breast cancer tissue, plan to enroll approximately 186 subjects in this Phase 3 clinical study, which is expected to commence in calendar Q1 2022. There will also be a scientific presentation on Inovasarm's anti-tumor activity in estrogen-blocking agent and CDK-4-6 inhibitor-resistant human metastatic breast cancer models at the upcoming San Antonio Breast Cancer Symposium, which will be held December 7th through the 10th of 2021, to be presented by Dr. L. Jean Lim, of the Garvan Institute of Medical Research and the Kinghorn Cancer Center at St. Fenton Hospital of Sydney, Australia.

Just on the positive phase II clinical data and the preclinical data supporting the use of a nobu storm in combination with CDK <unk> inhibitor in patients who have CDK four shakes inhibitor estrogen blocking agent resistant we plan to conduct a phase III multicenter open label randomized one to one active control registry.

Ration clinical study named enabler to evaluate the efficacy and safety with nobu surplus of Burma cyclic combination therapy versus an alternative estrogen blocking agent in subjects with a positive you're positive or.

Negative metastatic breast cancer, who have failed first line therapy with power, both cyclic which is a CDK <unk> inhibitor, plus an estrogen blocking agents and have greater than equal to 40% air expression and their breast cancer tissue.

We plan to enroll approximately 186 subjects in this phase III clinical study, which is expected to commence in calendar Q1, 2022.

It will also be a scientific presentation of the nobu Sarge antitumor activity in estrogen blocking agents CDK four six inhibitor resistant human metastatic breast cancer models at the upcoming San Antonio breast cancer Symposium, which will be held December seven through the 10th 2021 to be presented by Dr.

LG Lim.

The Guard band Institute of Medical Research in the Kingdom Cancer Center and St. Francis Hospital in Sydney, Australia.

Although the presentations onto embargo, we cannot share the exciting scientific data until next week, what I can say is at these scientific results clearly demonstrate the antitumor synergy of the combination of the nobu assortment of CDK <unk> inhibitor to treat patients who developed tumor progression after receiving an estrogen blocking agent.

Mitchell Steiner: Although the presentation is under embargo, and we cannot share the exciting scientific data until next week, what I can say is that these scientific results clearly demonstrate the anti-tumor synergy of the combination of Inovasarm and a CDK4-6 inhibitor to treat patients who develop tumor progression after receiving an estrogen-blocking agent and a CDK4-6 inhibitor. For AR positive metastatic triple negative breast cancer patients, we will be conducting a phase two single-arm study evaluating a novus arm plus subvisibulin combination therapy. As previously mentioned, Tebizabulin is an oral first-in-class new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton.

And the CDK <unk> inhibitors.

Finally.

ER positive metastatic triple negative breast cancer patients, we will be conducting a phase two single arm study evaluating <unk> plus the <unk> combination therapy.

As previously mentioned <unk> is an oral first in class new chemical entity that targets and inhibits microtubules disrupt decided the skeleton.

Overexpression of people at P glycoprotein as a common mechanism at least a taxane and other chemotherapy resistance in metastatic triple negative breast cancer.

Mitchell Steiner: Overexpression of people like a protein is a common mechanism that leads to taxane and other chemotherapy resistance in metastatic triple-negative breast cancer. Subisubule is not a substrate for the peacock approach, and it significantly inhibited cancer proliferation, migration, metastasis, and evasion in triple negative breast cancers that become resistant to paclitaxel in preclinical models. Furthermore, in a Phase II study conducted by Merck, 18 heavily pretreated women with AR-positive metastatic triple negative breast cancer treated by Inovasarum plus Pemrolizumab combination demonstrated promising evidence of efficacy, including a 25% clinical benefit rate, which is the complete response added to the partial response added to stable disease at 16 weeks, and objective tumor responses, for which they showed one complete response and one partial response.

<unk> not a substrate for P glycoprotein <unk> significantly inhibited cancer proliferation migration metastasis, an invasion of triple negative breast cancers that have become resistant to paclitaxel in preclinical models. Furthermore, in a phase II study conducted by Merck.

18 heavily pre treated women with ER positive metastatic triple negative breast cancer treated by <unk> plus chemo lizardman.

Combination demonstrated prominent evident prominent promising evidence of that.

Efficacy, including a 25% clinical benefit rate, which is the complete response your attitude or partial response and stable disease at 16 weeks and objective tumor responses with they showed one complete response and one partial response.

Thus the combination of two oral agents is appealing and oversaw may provide a new treatment option for women, who have ER positive metastatic triple negative breast cancer, we intend to commence a single arm <unk> plus <unk> combination therapy phase II clinical study.

Mitchell Steiner: Thus, the combination of two oral agents, Subizibulin and Novazone, may provide a new treatment option for women who have AR-positive metastatic triple negative breast cancer. We intend to commence the single-arm, subvisorbulin, placenovasome combination therapy phase two clinical study in approximately 111 women with AR-positive metastatic triple negative breast cancer who have tumor progression after receiving at least two systemic chemotherapies in calendar Q1, 2022. We are partnering with Roche Ventana, a major global diagnostics company, to develop a companion diagnostic androgen receptor test. In the Phase 2, Eta-1 study, we determined that the presence and the amount of angioreceptor expression in breast cancer tissue are important for ANOVAXARM's targeted anti-tumor activity.

Mitchell Steiner: In fact, we have identified that patients who have greater than or equal to 40% antigen receptor nucleotide staining by immunohistochemistry, which is a measure of AR expression in their breast cancer tissue, are the patients that are most likely to respond to ANOVAXARM. Based on this observation, the FDA has recommended that we develop a companion diagnostic test to determine the patient's AR expression status. Consequently, we are partnering with Roche Ventana Diagnostics, a world leader in oncology companion diagnostic tests, who will develop, and, if approved, commercialize this companion diagnostic AR test. The companion diagnostic test will be developed in parallel with the phase three AR test clinical study.

<unk> 111 men women with ER positive metastatic triple negative breast cancer with tumor congrats yes tumor progression after receiving at least two systemic chemotherapies calendar Q1 2022.

We have partnered with Roche Ventana.

In major global Diagnostics company to develop a companion diagnostic androgen receptor test.

In the Phase 281 study, we have determined that the presence in the amounts of the androgen receptor expression in breast cancer tissue or.

More important for nobu storms targeted antitumor activity in fact, we have identified the patients who have greater than equal to 40% androgen receptor nuclear outstanding by immuno histochemistry, which is a measure of <unk> expression in their breast cancer tissue or the patients that are most likely to respond to a noga time based.

Based on this observation.

<unk> has recommended that we develop a companion diagnostic test to determine the patients expression status.

Consequently, we are partnering with Roche Ventana diagnostics, a world leader in oncology companion diagnostic tests, who will develop.

If approved commercialize this companion diagnostic test the companion diagnostic tests will be developed in parallel with the phase III <unk> clinical study.

Fiscal year 2022, we will have an expansive breast cancer program and plan to be conducting four late stage clinical studies for the treatment of different large and important populations with significant unmet medical need in metastatic breast cancer.

Mitchell Steiner: In fiscal year 2022, we will have an expansive breast cancer program and plan to be conducting four late-stage clinical studies for the treatment of different large and important populations of significant unmet medical need in metastatic breast cancer. Also, in fiscal year 2021, our prostate cancer program made great progress. We have late clinical stage studies addressing three separate indications. Our first indication is evaluating sibizibulin for the third-line treatment of metastatic prostate cancer in the Phase III voracity study.

Also in fiscal year 2021, our prostate cancer program has made great progress we have late clinical stage studies addressing three separate indications.

Our first indication is evaluating <unk> for the third line treatment of metastatic prostate cancer in the phase III <unk> study.

Over the past eight years several novel androgen receptor targeting agents have been approved catastrophe Asian resistant prostate cancer, including Abiraterone has alluded Mike Napoli demanded.

Mitchell Steiner: Over the past eight years, several novel androgen-receptive targeting agents have been approved for castration-resistant prostate cancer, including abiraterone, enzalutamide, and apalutamide. Unfortunately, most men with metastatic, castration-resistant prostate cancer will develop tumor progression while receiving an angioaceptive target in age, kicks you to 70% of patients progressing by 12 to 18 months and 30-40% of men having no benefit at all, new effective and well-tolerated treatment alternatives that do not target the angio-receptive axis and have an easy mode of administration with great benefits. Ms. Bulin is a member of a novel class of trusts that disrupts the cytoskeleton by targeting unique binding sites of microtubules, which results in an improved safety profile.

Unfortunately, most men with metastatic castration resistant prostate cancer will develop tumor progression, while receiving an engine, which set the targeted agent, 60% to 70% of patients progressing back to 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 the Andrew we shipped two axes and have an easy mode of administration are greatly needed.

Mr. Bula, who is a member of a novel class of trust that disrupts decided skelton by targeting unique binding sites of microtubules, resulting in improved safety profile in preclinical.

Models. So there was no evidence of significant liver toxicity, neurotoxicity, and neutropenia, which would distribute on treatment.

Mitchell Steiner: In preclinical models, there was no evidence of significant liver toxicity, neurotoxicity, and neutropenia with subisibulin treatment. This more tolerable safety profile was also confirmed in the first-in-man Phase 1B2 study in prostate cancer patients. At a recent presentation by the European Societies of Medical Oncology Congress that was held September 16-21, 2021, we provided an updated analysis of the 80 patients enrolled in both the Phase I-B and Phase II portions of the study. These subjects were heavily pre-treated and had tumor progression while receiving at least one novel androgen receptor-targeted agent.

It's more tolerable safety profile was also confirmed in the first in man Phase <unk> two study in prostate cancer patients.

At a recent presentation at the European Society for medical Oncology Congress that Michelle September 16 to 21 2021, we provided an updated analysis of the 80 patients enrolled in both the phase <unk> phase II portion of the study.

Subjects were heavily pretreated and had tumor progression, while receiving at least one novel Andrew receptor targeted agent in fact, approximately 40% of the subjects had tumor progression after receiving at least to androgen receptor targeted agents.

With regard to safety.

Mitchell Steiner: In fact, approximately 40% of the subjects had tumor progression after receiving at least two androgen receptor-targeted agents. In regard to safety, there were 54 men treated at the recommended phase 2 dose of subisibyl and 63 mg oral daily dosing in the phase 1b-2 combined study. The visibulum was well tolerated, with no clinically relevant neutropenia and neurotoxicity, and the most common adverse events were gastrointestinal-related, including diarrhea, nausea, and fatigue, which were predominantly low-grade 1 and 2.

There were 54 men treated at the recommended phase II dose of <unk> 63 milligrams oral daily dosing in the phase <unk> combined study.

<unk> was well tolerated with no clinically relevant neutropenia neurotoxicity and the most common adverse events were gastrointestinal related including diarrhea, nausea, and fatigue, which were predominantly low grade one and two.

As for efficacy and combining patients from both the phase <unk> in two studies, we received 63 milligrams of <unk> daily and had measurable measurable metastatic disease at baseline based on the prostate cancer working group three criteria. The median radiographic progression free survival estimate.

Mitchell Steiner: As for efficacy, in combining patients from both the Phase 1B and 2 studies who received 63 mg of subisibulin daily and had measurable metastatic disease at baseline, based on the prostate cancer working group 3 criteria, the median radiographic progression for survival is estimated to be 7.4 months with a range of 3.2 to 35 plus months, as there are still five patients on the study, two of whom have been on subizapulin without tumor At baseline, Purvis hits 1.1, and the overall response rate was 21%.

To be seven four months with a range of three 2% to 35 plus months.

As there are still five patients on this study, which two have been on cbeebies appealing without tumor progression almost three years.

In the phase <unk>, two study population with measurable disease at baseline per resist one one the overall response rate was 21%.

Based on this phase <unk> two study visit Beulah and demonstrated a safety profile similar to what has been reported in the literature for the novel antigen receptor targeted agents and has promising evidence.

Mitchell Steiner: Based on this Phase 1B2 study, subizabulin demonstrated a safety profile similar to what has been reported in the literature for novel angioreceptor-targeted agents and promising evidence of efficacy similar to or better than IV chemotherapy.

Could you see similar similar to or better than IV chemotherapy.

Thus these updated findings from our phase <unk> clinical study of <unk> and continue to support the potential of <unk> and filling a growing significant unmet medical need.

Mitchell Steiner: Thus, these updated findings from a Phase 1B2 clinical study of subizabulin continue to support the potential role of subizabulin filling a growing significant unmet medical need. In June, the company initiated an open-label, randomized, 2-to-1, multi-center, phase-three veracity clinical study evaluating sibizibulin versus an alternative antigen receptor-targeted agent for the treatment of chemotherapy-naive The primary endpoint is radiographic regression-free survival.

In June the company initiated an open label randomized two to one multicenter phase III <unk> clinical study evaluating <unk> versus an alternative androgen receptor targeted agent for the treatment of chemotherapy naive men with metastatic castration resistant prostate cancer, who had tumor progression that you're receiving.

At least one androgen receptor targeted agent.

Finally endpoint as radiographic progression free survival enrollment of the phase III <unk> clinical studies on track, we expect to enroll approximately 245 patients from 45 clinical centers in the U S.

Mitchell Steiner: Enrollment for the Phase III Varasity Clinical Study is on track. We expect to enroll approximately 245 patients from 45 clinical centers in the U.S. Our second clinical study is evaluating Veru 100, a GnRH antagonist three-month depot formulation, in a phase two dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Android deprivation therapy remains the mainstay primary therapy for advanced prostate cancer, but current Android deprivation therapy drug products have several important clinical shortcomings.

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

Androgen deprivation therapy remains the mainstay primary therapy for advanced prostate cancer, but current androgen deprivation therapy drug products of several important clinical shortfalls.

<unk> olive garden's Sodexo LHRH agonist, whose initial administration leads to a testosterone surge that leap.

Mitchell Steiner: Lupron Elgar-Zodex or LHR-Agonis, whose initial administration leads to a testosterone surge that lasts up to 21 days. Firmagon, a GNRH antagonist, is a large-volume subcutaneous injection formulation designed for only a single-month release. Religolex is an oral GnRH antagonist and has the potential for patient compliance concerns. In contrast, Vero 100 is a target product profile that addresses a number of these important clinical shortfalls of the currently commercial androgen deprivation therapy product, and is a long-acting GNRH antagonist designed to be administered as a small-volume subcutaneous three-month depot injection.

That lasts up to 21 days.

<unk> a gnrh antagonist is a large volume subcutaneous injection formulation designed for only a single month release.

<unk> is an oral gnrh antagonists.

As the potential for patient compliance concerns.

In contrast Bureau, one country has a target product profile that addresses a number of these important clinical shortfalls.

Currently commercial androgen deprivation therapy products.

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

Pier 100 drug products is expected to immediately suppress testosterone with no testosterone search grew 100 is a long acting injected depo.

Mitchell Steiner: Veru 100 is a drug product expected to immediately suppress testosterone with no testosterone surge. Veru 100 is a long-acting injected depot, which would ensure patient compliance while on treatment. Furthermore, as a class, GNRH antagonists have been shown to have fewer cardiovascular adverse events than an LHRH agonist.

With insurer patient compliance while on treatment.

The more as a class gnrh antagonists have been shown to have fewer cardiovascular adverse events and a an LHRH agonist.

In June the company initiated the phase II dose finding clinical study of <unk> 100, androgen deprivation therapy, and 35 men with hormone sensitive advanced prostate cancer.

Mitchell Steiner: In June, the company initiated the Phase II dose-finding clinical study of Vero 100 android deprivation therapy in 35 men with hormone-sensitive advanced prostate cancer. Although the study is ongoing, the preliminary clinical data are promising and support the expected target product profile. The Phase III Registration Clinical Study design has already been agreed upon with FDA. It will be a single-arm study that will involve approximately 100 men.

Although this study is ongoing the preclinical.

Luminary clinical data are promising and support the expected target product profile.

The phase III registration clinical study design has already been agreed upon by a pond with FDA.

It'll be a single arm study, which will enroll approximately 100 men.

Maintenance of castrate blood concentrations of testosterone is the primary endpoint.

Mitchell Steiner: Maintenance of castrate blood concentrations of testosterone is the primary endpoint. After the Phase 2 dose finding studies are completed, we will initiate the Phase 3 clinical study, which is anticipated to begin in the calendar first half of 2022. In our third late stage clinical study, we are advancing zuclomacine for the treatment of hot flashes caused by androgen deprivation therapy.

After the phase II dose finding studies completed we will initiate the phase III clinical study, which is anticipated to begin in calendar first half 2022.

In our third late stage clinical clinical study, we are advancing Xu Columbus <unk> for the treatment of hot flashes caused by androgen deprivation therapy. Upon further evaluation of the clinical data from our positive phase two should clomiphene clinical study, we decided that because there is a common feature excellent safety profile that we have.

Mitchell Steiner: Upon further evaluation of the clinical data from our positive Phase II Zuclomafine clinical study, we decided that because of Zuclomafine's excellent safety profile, we should optimize the efficacy of Zuclomafine to treat hoplites by further increasing the dose in a planned Phase IIb clinical study. In summary, we will have three late-stage clinical studies for the management of metastatic prostate cancer in fiscal year 2020. Veru has a base commercial sexual health division, which includes a commercial product, FC2, an FDA-approved product for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections, and the drug candidate, Intaxi, which is tetanafil 5 milligrams and finasteride 5 milligram capsule, a new treatment for benign prosthetic hypokalasia with an FDA-approved date this month. We have built the As a result, FC2 is now available through multiple sales channels.

Should optimize the efficacy to club has been to treat hot flashes by further increasing the dose and the planned phase III clinical studies.

Summary.

We will have three late stage clinical studies for the management of metastatic prostate cancer in fiscal year 2022.

Bureau has a base commercial sexual health Division, which includes our commercial product the FC to an FDA approved product for the dual protection against unplanned pregnancy and transmission of sexually transmitted infections and the drug candidates taxi, we just to battlefield five milligrams of finasteride five milligram capsule.

A new treatment could benign prostatic hyperplasia with FTA kudu predate this month.

We have built the infrastructure to allow for broad access to <unk> across the United States. As a result, <unk> is now available through multiple sales channels in particular in particular, we have partnered with fast growing highly reputable telemedicine platform companies to bring FCT product to patients and a cost effect.

Mitchell Steiner: In particular, we have partnered with fast-growing, highly reputable telemedicine platform companies to bring the FC2 product to patients in a cost-effective and highly convenient manner. Though Ms. Greco will provide the full financial results for Veru's commercial segment, which is FCQ and drug commercialization costs, I'm happy to report that we've achieved another record fiscal year. In fact, our revenue increased 44% to $61.3 million, which significantly exceeded the revenue of $42.6 million we had in fiscal year 2020.

They've been highly convenient manner.

Though Ms. Greco will provide the full financial results <unk> commercial segment, which is <unk> and drug commercialization costs I'm happy to report that we've achieved another record fiscal year in fact, our revenue increased 44%.

$61 $3 million, which significantly exceeded the revenue of $42 6 billion and fiscal year 2020.

Our strategy is to continue to drive robust FCC shales.

Mitchell Steiner: Our strategy to continue to drive robust FC2 sales is not only to seek additional telemedicine and pharmacy services partners but also to create our own dedicated direct-to-patient telemedicine pharmacy services platform, both to brand our company and to further sales growth. We plan to also launch our new name, UREV, for our women's health business. We also have developed ETAFI, a novel treatment for benign prostatic hyperplasia. The co-administration of sedalafil and finasteride has been shown to be more effective than treatment of benign prostatic hyperplasia and finasteride alone without causing sexual adverse side effects.

It's not only to seek additional telemedicine that pharmacy services partners, but also to create our own dedicated direct to patient telemedicine pharmacy services platform. Both the brand our company and to further sales into further sales growth.

We plan to also brands in our new name your Rev for our women's health business.

We also have developed a tap fee in novel treatment for benign prostatic hyperplasia co administration of the Dallas film Finasteride had been shown to be more effective.

And benign prostatic hyperplasia, and finasteride alone without causing sexual adverse side effects.

<unk> date is in December of 2021.

Mitchell Steiner: The PDUFA date is in December of 2021, and approved and TAFSI is expected to be marketed and distributed by our own director patient telemedicine and telemedicine plasma telepharmacy plasma. We have also partnered with GoodRx, a U.S.-based digital resource for health care, to reach their almost 20 million monthly visitors, which includes both consumers and health care providers, and offers a unique cash prize to ensure that our We expect to begin commercialization, if approved, in early calendar year 2022. I will now turn the call over to Michele Greco, CFO, and CAO, to discuss the financial highlights. Michele?

If approved the tendency is expected to be marketed and distributed by our own direct to patient telemedicine and telemedicine platform.

Pharmacy platform. We have also partnered with good Rx a U S based digital resource for health care to reach you almost 20 million monthly visitors, which includes both consumers and health care providers and offers a unique cash price to ensure that our treatment is more affordable and accessible.

We plan to augment our marketing and sales effort by seeking partners in the U S and ex U S. We expect to begin commercialization if approved in early calendar year 2022.

I will now turn the call over to Michele Greco CFO.

To discuss the financial highlights Michelle.

You'd have to sign or is that just staying or indicated we had another great year.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we had another great year. Last December, the company sold Preboost for $20 million, resulting in a gain on sale of $18.4 million. In February, the company completed an equity raise, which resulted in $108 million in net proceeds after deducting underwriting commissions and costs. And for the fiscal year, the company achieved record-level net revenues of $61.3 million and record-level gross profits of $47.9 million.

Last December the company felt previous $20 million, resulting in a gain on sale of $18 $4 million in February the company completed an equity raise which resulted in a $108 million and net proceeds after deducting underwriting commissions and costs.

And for the fiscal year the company achieved record level net revenues of $61 3 million and record level gross profit of $47 9 million.

Let's start with highlights of our fourth quarter results for fiscal year 2021.

Michele Greco: Let's start with highlights of our fourth quarter results for fiscal year 2021. Overall net revenues were up 33% to $15.6 million from $11.7 million in the prior year fourth quarter due to the growth in our U.S. FC2 prescription business. The company reported significant FC2 sales growth in its prescription business, with net revenues up 55% to $13.6 million from $8.7 million in the prior year fourth quarter. Gross profit was $12.3 million for 79% of net revenues compared to $9.6 million or 81% of net revenues in the prior year fourth quarter.

Overall, net revenues were up 33% to $15 $6 million from $11 $7 million in the prior year fourth quarter due to the growth in our U S. F C. Two prescription business.

The company reported significant FCT sales growth in its prescription business with net revenues up 55% to $13 $6 million from $8 $7 million in the prior year fourth quarter.

Gross profit was $12 $3 million or 79% of net revenues compared to $9 $6 million or 81% of net revenues in the prior year fourth quarter.

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

Michele Greco: The increase in gross profit is driven primarily by increased sales in our U.S. FD2 prescription business. Operating expenses for the quarter increased by $7.4 million to $14.2 million compared to the prior year fourth quarter of $6.7 million.

Operating expenses for the quarter increased by seven $4 million at $14 $2 million compared to the prior year fourth quarter of $6 $7 million.

Research and development costs were $8 $3 million compared to $3 $3 million in the prior year quarter due to the commencement of several new phases in a clinical trial.

Michele Greco: Research and development costs were $8.3 million compared to $3.3 million in the prior year quarter due to the commencement of several new phases in our clinical trial. In the fourth quarter of fiscal 2020, we recorded a non-cash impairment charge of $14.1 million related to in-process research and development associated with the acquisition of Aspen Park Pharmaceuticals in fiscal 2017. Operating loss for the quarter was $1.9 million compared to the prior period of $11.3 million, which included a non-cash impairment charge of $14.1 million.

During the fourth quarter of fiscal 2020, we recorded a noncash impairment charge of $14 $1 million related to in process research and development associated with the acquisition of Aspen Park Pharmaceuticals in fiscal 2017.

Operating loss for the quarter was $1 9 million.

Compared to the prior period of $11 3 million, which included the noncash impairment charge of $14 $1 million.

Non operating expenses were $2 $8 million compared to $1 $7 million in the prior year fourth quarter and primarily consisted of interest expense and a change in the fair value of the derivative liabilities related to the synthetic royalty financing we entered the synthetic royalty financing during March of 2018.

Michele Greco: Non-operating expenses were $2.8 million compared to $1.7 million in the prior year fourth quarter and primarily consisted of interest expense and a change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered into the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax benefit of $356,000 compared to a tax benefit of $1.1 million in the prior year for the quarter. The effective tax rate for this quarter is 7.7% and 8.6% for the prior year quarter due to recording an evaluation allowance against the net operating loss generated for the quarter in the U.S., which is most of the pre-tax loss for the period.

For the quarter, we recorded a tax benefit of $356000 compared to a tax benefit of $1 $1 million in the prior year fourth quarter the.

The effective tax rate for this quarter at seven 7% and eight 6% for the prior year quarter due to recording a valuation allowance against the net operating loss generated for the quarter in the U S, which is most of the pretax loss for the period.

The bottom line results for the fourth quarter fiscal 2021, with a net loss of $4 $3 million or five cents per diluted common share compared to a net loss of $11 $8 million or 17 cents per diluted common share in the prior year fourth quarter.

Michele Greco: The bottom line results for the fourth quarter of fiscal 2021 were a net loss of 4.3 million dollars for 5 cents per diluted common share compared to a net loss of 11.8 million dollars for 17 cents per diluted common share in the prior year fourth quarter. Now turning to the results for the fiscal year-end, September 30th, 2021. Total net revenues for fiscal year 2021 were up 44% to a record high of $61.3 million from $42.6 million in the prior year.

Now turning to the results for the fiscal year ended September 30th 2021.

Total net revenues for fiscal year, 2021 were up 44% to a record high of $61 $3 million from $42 $6 million in the prior year.

Michele Greco: The company reported growth in FC2 sales in the U.S. prescription business and in the global public sector business. Net revenues from the U.S. prescription business were up 71 percent to $46.5 million from $27.1 million in the prior year. Net revenue for the global public health sector business was $13.9 million for the fiscal year.

Company were pretty growth in <unk> sales in the U S prescription business and in the global public sector business.

Revenues from the U S prescription business was up 71% to $46 $5 million from $27 $1 million in the prior year.

Net revenue for global public health sector business with $13 $9 million for the fiscal year.

Overall gross profit was $47 $9 million or 78% of net revenues.

Michele Greco: Overall gross profit was $47.9 million for 78% of net revenues compared to $30.8 million for 72% of net revenues in the prior year. The increase in gross profit and gross margin is due primarily to an increase in the U.S. prescription business. Operating expenses increased to $53.3 million compared to the prior year of $31.4 million. The increase is primarily driven by research and development costs, which increased to $32.7 million from $16.9 million in the prior year, and increases in the cost of personnel insurance and commercialization.

$38 million or 72% net revenues in the prior year.

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

Operating expenses increased to $53 $3 million compared to the prior year of $31 $4 million.

The increase was primarily driven by research and development costs, which increased to $32 $7 million from $16 $9 million in the prior year and increases in the cost per personnel insurance and commercialization.

During the prior year the company received a forgivable loan of approximately $540000 under the Paycheck protection program of the cares Act.

Michele Greco: During the prior year, the company received a forgivable loan of approximately $540,000 under the Paycheck Protection Program of the CARES Act. The forgivable loan was treated like a government grant and recognized as a reduction in operating expenses. During the first quarter of fiscal 2021, we sold pre-boosts, resulting in a pre-tax gain of $18.4 million. During the fourth quarter of the prior year, there was a non-cash impairment charge of $14.1 million. Operating income for the year was $13 million, which included $18.4 million related to the gain and sale of pre-boosts, compared to an operating loss of $14.7 million in the prior year, which included a non-cash impairment charge of $14.1 million. Non-operating expenses were $8.7 million compared to $5.3 million in the prior year, which primarily consisted of interest expense and a change in the fair value of the derivative liability related to synthetic royalty finance.

First given the long was treated like a government grant and recognize the risk of infection and operating expenses.

During the first quarter of fiscal 2021, we sold peoples, resulting in a pretax gain of $18 $4 million during the fourth quarter in the prior year, there was a noncash impairment charge of $14 $1 million.

Operating income for the year was $13 million, which includes the $18 $4 million related to the gain on sale of peoples compared to an operating loss of $14 $7 million in the prior year, which includes the noncash impairment charge of $14 $1 million.

Non operating expenses were $8 $7 million compared to $5 $3 million in the prior year, which primarily consisted of interest expense and change in the fair value of the derivative liabilities related to synthetic royalty financing.

The year, we recorded a tax benefit of $3 $1 million compared to $1 $1 million from the prior year.

Michele Greco: And for the year, we recorded a tax benefit of $3.1 million, compared to $1.1 million in the prior year. The tax benefit primarily relates to an increase in UK tax rates from 19% to 25%, which will be effective in fiscal 2023. This change in tax rates increased the value that we expect to derive from our net operating losses in the UK. The company has net operating loss carry-forwards for U.S. federal tax purposes of $39.1 million, with $30.5 million expiring in years through 2040 and $8.6 million, which can be carried forward indefinitely.

The tax benefit primarily related to an increase in U K tax rate from 19% to 25%, which will be effective in fiscal 2023. This change in tax rates increase the value that we expect to derive from our net operating losses in the U K the.

The company has net operating loss carryforwards for U S federal tax purposes of $39 $1 million with $35 million expiring in years through 2040, and $8 $6 million, which can be carried forward indefinitely and our U K subsidiary has net operating loss carryforwards of $63 $5 million, which.

Do not expire.

The bottom line results for fiscal year, 2021, with net income of $7 $4 million or nine cents per diluted common share compared to a net loss of $19 million for 28 cents per diluted common share in the prior year.

Michele Greco: And our U.K. subsidiary has net operating loss carry-forwards of $63.5 million, which do not expire. The bottom-line result for fiscal year 2021 was net income of $7.4 million, or $0.09 for diluted common share, compared to a net loss of $19 million, or $0.28 for diluted common share, in the prior year.

Now turning to the balance sheet as of September 32021, our cash balance was $122 $4 million and our accounts receivable balance was $8 $8 million. Our net working capital was $136 million on September 32021, compared to $12 $3 million on September 30.

Michele Greco: Now turning to the balance sheet, as of September 30th, 2021, our cash balance was $122.4 million, and our accounts receivable balance was $8.8 million. Our net working capital was $136 million on September 30th, 2021 compared to $12.3 million on September 30th, 2020. Due to the sale of Preboost in December of 2020, we added $15 million in cash and $5 million in notes receivable, $2.5 million of which will be collected this month and the remaining $2.5 million, which will be collected over the next six months. In February, we completed an underwritten public offering that resulted in net proceeds of $108 million.

<unk> 2020.

Just sale of peoples in December 2020, we added $15 million in cash and $5 million in notes receivable of $2 5 million, which will be collected this month and the remaining $2 5 million, which will be collected over the next six months.

In February we completed an underwritten public offering that resulted in net proceeds of $108 million.

During the fiscal year ended September 30th 2021 we used cash of $15 6 million for operating activities.

Michele Greco: During the fiscal year ended September 30, 2021, we used cash of $15.6 million for operating activities. Overall, we're delighted to see the continued increases in sales in the FC2 business. 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 opportunistic by joining the global efforts to find effective treatments for COVID-19. Now, I'd like to turn the call back to Dr. Stein

Overall, we're delighted to see the continued increases in sales in the SPT business.

This revenue source together with our strong balance sheet continues to be the source of the 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 opportunity in breast and prostate cancers as well as being aperture.

Mystic by joining the global effort to find effective treatments for COVID-19.

Now I'd like to turn the call back to Dr. Steiner. Thank you Michelle we've enjoyed a record year, which has allowed us to significantly advance our clinical oncology programs. In fact, we are now entering our fifth year of growth in our FC two U S. Prescription business, we had a record year of $61 $3 million in revenue we plan to.

Mitchell Steiner: Thank you, Michele. We've enjoyed a record year, which has allowed us to significantly advance our clinical oncology programs. In fact, we are now entering our fifth year of growth in our FC2US prescription business. We had a record year of $61.3 million in revenue.

Commercially launching tatty approved via telemedicine portable and potential licensing deals, which will provide even more revenue adding to the already growing revenues from ex U two.

Mitchell Steiner: We plan to commercially launch in TADP, if approved, via the Telemedicine Portal and potential licensing deals, which will provide even more revenue, adding to the already growing revenues from FC2. We expect another record year in FY2022. With resources in place, we will continue to advance our expansive late-clinical stage breast cancer and prostate cancer programs, as well as phase three COVID-19 clinical study that is expected to have results in the first half of 2022.

We expect another record year in fiscal year 2022 with.

With resources in place, we will continue to advance our expansive late clinical stage breast cancer and prostate cancer programs as well as phase III COVID-19 clinical study is expected to have results in the first half of 2022.

Dissipate a steady flow of important positive news for <unk> over the next few months to one year.

Mitchell Steiner: We anticipate a steady flow of important positive news for Veru over the next few months to one year. In summary, we have evolved into an oncology biopharmaceutical company solidly dedicated to developing treatments for breast cancer and prostate cancer. A strategy to advance the clinical development of our drug candidates by investing revenues generated by our sexual health division is working. As a stand-alone business, our women's health business, UREV, is valuable, profitable, and growing, which provides optionality for Veru shareholders.

In summary, we have evolved into an oncology biopharmaceutical company solidly dedicated to developing treatments for breast cancer and prostate cancer.

Strategy to advance the clinical development of our drug candidates by investing revenues generated by our sexual health Division is working as a standalone business, our womens health business you ramp is.

<unk> profitable and growing which provides optionality to various shareholders I.

I am proud of the hard working dedicated and talented talented team we have assembled to execute our clinical and commercial strategy we have.

Mitchell Steiner: I am proud of the hardworking, dedicated, and talented team we have assembled to execute our clinical and commercial strategy. We are committed to driving shareholder value by developing commercial novel medicines, addressing significant unmet medical needs for the management of breast cancer and prostate cancer, and being opportunistic, and developing subutabulin for hospitalized COVID-19 patients. High Risk for Acute Respiratory Distress Syndrome, and with that, I'll now open the call to questions. Operator.

We are committed to driving shareholder value by developing commercial novel medicines addressing significant unmet medical need that a management of breast cancer prostate cancer and being opportunistic.

Developing <unk> go hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome and death.

I'll now open the call to questions operator.

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

Operator: 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 a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality.

I'll ask a question you May press Star then one on your telephone keypad.

If you're using a speaker phone.

To keep your handset before pressing the keys to ensure the best sound quality.

Withdraw your question. Please press Star then two please.

Operator: To withdraw your question, please press star, then two. Please limit yourself to one question and one follow-up. If you have further questions, you may re-enter the question queue. Once again, that is star, then one to rejoin the question queue. Our first question comes from Brandon Foulkes from Cantor Fitzgerald. Please go ahead.

Please limit yourself to one question and one follow up.

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

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

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

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

Brandon Foulkes: Hi, thanks for taking my question, Dan. Congratulations on all the progress. So the two questions for me, maybe just on the Zebulon and COVID, can you remind me what control arm is able to be dosed with?

So the two questions maybe just on the.

And Covid can you remind me what control arm is able to be dosed with and then along those lines.

Active are you in dialogue with the respective agencies unnoticed endpoint, just as sort of COVID-19 treatments evolve.

I guess my second question I'll, just ask upfront on today's villain again in the third line monotherapy in breast.

Did you receive the safe to proceed data from the FDA. So can you just.

Let us now are there any other hurdles you have to overcome between now and starting to phase two b was it I'll just add.

Are you just really setting up the study and getting it running in the first quarter of next year. Thank you.

First of all Brandon Thank you for being on the call and.

Brandon Foulkes: And then along those lines, how active are you in dialogue with the respective agencies on those endpoints, just as COVID treatments evolve? I guess my second question I'll just ask up front: on Zebulon again in the third line, monotherapy, and breast, you noted you received the safe to proceed letter from the FDA. So can you just let us know, are there any other hurdles you have to overcome between now and starting phase two B, or is it now just the... Are you just really setting up the stadium, getting it running in this first quarter of next year? Thank you. First of all, Brandon, thank you for being on the call.

So the I'm going to answer your second question first so that's an easy one so safe to proceed letter is as you know.

Mitchell Steiner: And I'm going to answer your second question first, so that's an easy one. So, the Safe to Proceed letter is typically what you do technically after you file. This had to be filed as a separate IND because it's a different drug. And with that said, the Safe to Proceed letter is the official green light from the FDA to move forward. There are no other hurdles.

Typically.

Would you do technically after you file they said it would be filed as a separate R&D because its a different drug.

And with that said save a proceed letter is the official green light from the FDA to move forward. There are no other hurdles and so the so all we're doing now is we have to do you've got everybody engaged.

Mitchell Steiner: And so all we're doing now is we have got everybody engaged. We have a CRO ready and ready to go. And just to pause for a moment, let me tell you why this is unique and maybe didn't come across in the call. What we're doing is we're actually asking, if you look at the populations of the patients in the greater than 40 and less than 40 age groups, the same population of patients, these are patients that have received at least two estrogen-blocking agents and a CDK46 inhibitor; they're all third-line.

Crowed ready and ready to go.

And just to pause for a moment, let me tell you why this is unique it maybe didn't come across in the call.

What we're doing is we're actually asking you. If you look at the population of patients in the greater than 40, unless it 40 St population of patients. These are patients that have received at least two estrogen blocking agents in the CDK four six inhibitors all third line.

So when they come into the study and then they then then the companion diagnostic with this case.

Mitchell Steiner: So when they come into the study, the companion diagnostic, or, in this case, you know, the CLIA test, looks for their AR status. If their AR status is greater than 40, greater than or equal to 40, then they go on to the AR test study.

The CLIA test will look through the AAR establish if there are status is greater than 40 greater than equal to 40, then they go on PDR test study it was less than 40.

Mitchell Steiner: If it's less than 40, then they go to the Phase 2B study. So, in some ways, they're sister companion studies. And so we're being incredibly efficient with money because that same patient, instead of being told they can't be in the study and you chalk that up as a screen failure, whatever you call that, now we have an opportunity to capture that patient in one or the other study. So it really is a very efficient way to fill that study. So maybe that didn't come across as loudly as I'd like it to, but with that said, there are no hurdles.

Then they go to the phase <unk> study so in some ways. They are sister companion studies, and so we're being incredibly efficient with money.

Because that same patient instead of being told you can't be in the study.

Chalk that up to the screen failure, whether you call that now.

Now, we have an opportunity to capture that patient in one or the other study. So it really is a very efficient way to fill that study. So so maybe that didn't come across.

As loudly as I would like it to but with that said there are no hurdles and in fact, we're starting to collect patients for recruitment because the art test studies up and running and we do have patients who are less than 40, so it'll be pretty efficient.

Mitchell Steiner: And in fact, we're starting to recruit patients for recruitment because our test study is up and running, and we do have patients who are less than 40, so it will be pretty efficient. So our thinking was that since we know less than 40s are not going to respond the way the greater than 40s do, let's take advantage of whatever else we have. As it relates to the second question, I'll frame the question.

So our thinking was that since we know less than 40 is that not going to I'm not going to respond the way the greater than forties due let's take advantage of it was out of one of our assets as it relates to the second question I'll frame. The question, we're very fortunate in half year, Dr. Gary Barnett will answer the question.

Mitchell Steiner: We're very fortunate to have here Dr. Gary Barnett who will answer the question. And that was basically for the COVID-19 study, looking at the control arm, just to remind you again what that control arm was in phase 2B, and then what the control arm is in phase 3. And then the other part of your question was, you know, the dialogue with the FDA in relation to that endpoint and how comfortable they are with that.

It was basically for the COVID-19 study looking at the control arm just to remind you again, what that control arm was in the phase two b and then what the control arm is in that phase III and then the other part of your question was.

Dialogue with the FDA late in relation to that endpoint and how comfortable they are with that end point, Gary It's Ron.

The phase II study and the Phase III study, we do allows standard of care. These are both blind phase II is a blinded study. This is a blood study ethically, we need to allow them to have standard of care things like that the message though.

Mitchell Steiner: And so in the Phase 2 study and in the Phase 3 study, we do allow standard of care. These are both blind—the Phase 2 is a blind study, this is a blind study. We—ethically, we need to allow them to have standard of care, things like dexamethasone, remdesivir, the other products that have been approved by the FDA through the EUA process.

That's where the other products that have been approved by the FDA.

Through the EUA process.

And then on top of that we have a blinded either the patient is randomized to <unk> or to placebo. That's how the studies work in this phase III study is identical in that way to the phase II, where we showed the benefit.

Mitchell Steiner: And then on top of that, we have a blinded—either the patient is randomized to subizobulin or to placebo. That's how the studies work. And the Phase 3 study is identical in that way to the Phase 2, where we showed the benefits. As far as the end point, the FDA's, you know, obviously, mortality or death is the gold standard end point for just about every clinical trial you have or you could have.

As far as the endpoint the FDA.

Mortality or death.

As the gold standard.

For just about every clinical trial, you have or you could have that we don't use it much because most of the time, we're trying to do something else, but so the FDA is very comfortable with.

Mitchell Steiner: Now, we don't use it much because most of the time we're trying to do something else, but the FDA is very comfortable with death as the primary end point, and based on the phase two data we have and the data we're seeing in the literature, we feel very comfortable that that's where we should be. I think the other statement I will make is that, you know, the reason I brought this up is that the Merck and Pfizer drugs are not for hospitalized patients. In fact, the Merck drug failed in hospitalizing patients.

As the primary employees based on the phase two data we are in the data we're seeing in the in the literature, we feel very comfortable with that so that's where we should be I.

I think the other statement I would make is that.

You know, it's been but the reason I brought it up the Merck and Pfizer drugs are not for hospitalized patients.

The Merck drug sales in hospitalized patients so they're pre hospitalized patients in this patient this patient group will have a much much lower overall death rate.

Mitchell Steiner: So they're in pre-hospitalized patients, and this patient group will have a much, much lower overall death rate than the hospitalized patients. And in the hospitalized patients, one of the concerns we had running this study was that perhaps with this, quote, standard of care dexamethasone, Remdesivir, you know, and Mitchell Dean, than what we saw in phase two. And so we can say that in aggregate. And so we're feeling pretty good that there is a big difference between going after patients in a pre-hospitalization state versus a hospitalized standpoint because the hospitalized patients are definitely sicker.

And and in hospitalized patients one of the concerns we had running this study was that perhaps with this quote standard of care dexamethasone and desert view.

Drug antibody cocktails and that kind of stuff that the death rate would be at a point that it's much lower that we would need a huge study.

Not the case, we are learning is that patients are coming in W. H O fives and sixes.

And quite frankly floors.

These.

<unk> is the same if not higher.

Then what we saw in the phase II.

And so we can say that in aggregate and so so we feel pretty good that there is a big difference between going after patients that are pre hospitalization.

Standpoint.

Versus a hospitalized standpoint theres the hospitalized patients are definitely sicker. So that's that's why we think we have a big position.

Mitchell Steiner: So that's why we think we have a position in our drive at this point now. There have really been no effective drugs, oral drugs, that have been approved in this space, or any coming anytime soon. So we really own this space, and that's why we've got to push it pretty hard. Thanks.

Acquisition.

With our drive that at this point now.

It really been no effective drugs.

Oral drugs have been approved in this space or any coming up coming anytime soon so we really own this space and that's why we've got to push it push it pretty hard.

Okay.

Next question.

Next question is from Leland <unk> from Oppenheimer. Please go ahead.

Mitchell Steiner: Next question. The next question is from Leland Gershell from Oppenheimer. Please go ahead. Bordy, Mitch, thank you for taking my question. Just actually one question. It's on subizabulin.

What are your bench. Thank you for taking my question just actually one question on so visit fueling.

Mechanistic one another.

Leland Gershell: It's kind of a mechanistic one. You know, there's another compound being developed elsewhere, plinibulin, which also binds proximate to the typical cytosine binding site on tubulin. And in addition to that, it's recently been published that that compound may play an immuno-oncologic role as it releases an immune defense protein, GFH1. I'm just wondering if, in the work you've done with subizabulin, you've seen other elements of activity that may be along those lines, you know, in addition to the known activity with the disruption of microtubules.

Another compound being developed elsewhere, Pollinium fueling, which also binds proximate to the approaches and binding site on tubular.

And in addition to that it's been recently published that that compound and they play in immuno oncological.

As it has it releases.

Isn't immune defense protein G FH one.

I'm just wondering if on work you've done with <unk> and <unk> seen other elements of the activity that may be along those lines.

In addition to the trial.

Known activity with the disruption of microtubules. Thank you.

Thank you so yeah from a mechanistic standpoint, I mean, let me just pause for a moment and tell you what I think is happening with <unk>. So first of all from a mechanistic standpoint.

Mitchell Steiner: Thank you. Thank you. So yeah, from a mechanistic standpoint, let me just pause for a moment and tell you what I think is happening with plenibulin. So first of all, from a mechanistic standpoint, plenibulin started out as a colchicine binding compound, focusing the binding site compound on the beta subunit tube.

Bulent started out as a coach seat binding compound.

Focusing binding site compound.

The beta SAPIEN into to do it.

And what.

Mitchell Steiner: And what I don't know, quite frankly, is what it does to the output subunits of 2B. So the alpha... The binding site on the alpha tubulin subunit, I don't know. With our compound, what makes it different, and that's why I keep saying we're a novel class, is that it looks like I have not seen another compound that has hydrogen bonding on the beta subunit and hydrogen bonding on the alpha subunits, the two groups. And so that's why we're saying it's cross-linking because those bonds are so strong that they're actually cross-linking, causing the microtubules not only to not be able to polymerize, but they also cause them to de-polymerize.

But I don't know quite frankly.

Is what does it do on the alpha subunit of tubular.

So the so the alpha.

The alpha.

The binding site on the alpha tubular at Cepheid.

I don't know okay.

With our compounds it makes it different and that's why I keep saying, we're a novel class is that it looks like that's another compound that has hydrogen bonding.

Beta subunits, and the hygiene and bonding on the alpha subunit tubular and so that's why we were saying it's cross link Easter those bonds are so strong that it's actually cross linking causing the microtubules not only to not be able to polymerize, but also they cause them to deep library.

It was a little different now with that said.

Mitchell Steiner: And so it's a little different. Now, with that said, and we think this is the reason for the safety, we do think there's some overlap. So Clinibulin clinically shows a reduction in neutropenia, and in the story, and they had a very successful phase 3 that showed a reduction in neutropenia. But as you know, when you go after side effects of chemotherapy, the agency usually requires two clinical studies, and so even though Clinibulin shows great success and proof of concept in a phase 3 setting that it can reduce the neutropenia induced by chemotherapy, the So, it's not shocking from my point of view.

And we think this is the reason for the safety. We do think there is some overlap.

So kind of bulent clinically shows a reduction in neutropenia.

And the story and they had a very successful phase III that showed a reduction of neutropenia, but as you know when you go after side effects.

<unk> chemotherapy the agency usually requires two clinical studies.

And so even though.

Glenn are fueling shows great success and proof of concept phase III setting that it can reduce neutropenia induced by chemotherapy.

<unk> is the second one so its not shocking from my point of view and you know I don't have.

Mitchell Steiner: And, you know, I don't know, I have not read the regulatory documents or anything like that, but from the outside looking in, you know, they usually want two. Like, for example, our hot flash product, even though we're treating cancer patients, the FDA has made it very clear they'd like two pivotal studies, phase two being three. They want two studies where they can move forward with treating the side effects of a cancer drug, so in this case, treating the side effects of angio deprivation therapy-induced hot flashes. Same thing here; it's chemotherapy-induced neutropenia.

And that read the regulatory documents or anything like that but from the outside looking in.

You didn't want to like for example, our hot Flash product.

Even though we're treating cancer patients. The FDA has made it very clear they'd like to pivotal studies will be phase two being a three they want two studies, where they can move forward with it between the side effects of cancer drugs. So in this case between the side effects of androgen deprivation therapy induced hot flashes same thing he was chemotherapy induced.

Neutropenia.

So its similar as it relates to other things I will tell you that.

Mitchell Steiner: So it's similar. As it relates to other things, I will tell you that, you know, subizobulin has already shown us that it can have activity as an antiviral and anti-inflammatory, and that's why we're using it in COVID-19. And we've actually, you know, presented, you know, put out in the press release the anti-inflammatory activity across multiple cytokine proteins that are downregulated or inhibited by subizobulin. And so it's not surprising to me that Subutabulin may have immunomodulating activities, but we have not tested specifically the immunomodulating activities that Clonabulin may have.

She does abutilon has already shown us that he can have activity.

<unk> as an antiviral and anti inflammatory and that's why we're using it in.

And COVID-19, and we've actually presents.

Put out in the press release, the anti inflammatory activity across multiple cytokines.

<unk> proteins that are down regulated or inhibited by some visibility.

So it's not surprising to me.

That <unk> may have immuno regulatory immuno modulating activities.

But we have not tested specifically the immuno modulating activities that quite appealing. So I can't tell you whether it was similar in that regard, but that would not be surprised so so the net net of it is will be different but there is some overlap.

Yi Chen: So I can't tell you whether it was similar in that regard, but I would not be surprised. So the net-net of it is we're different, but there's some overlap. What we can say about sub-isobutyl and all that preclinical stuff that we showed, you know, neutropenia, and neurotoxicity in the preclinical models didn't appear to be important or did not appear to happen with the compound played out in the clinical trials. And so we're feeling pretty good going forward in breast cancer that we should be able to still see the favorable side effect profile. So, thank you. Thank you. Next question, please. This next question is from Yi Chen of H.C. Wainwright. Please go ahead.

What we can say about <unk> of that preclinical stock will be showed neutropenia neurotoxicity in the preclinical models didn't appear to be important.

It did not appear to happen with the compound played out in the clinical model and so we're feeling pretty good going forward in breast cancer that we should be able to still see the favorable side effect profile disputes.

Okay. Thank you.

Thank you next question please.

Next question is from <unk> Chen from H C. Wainwright. Please go ahead.

Thank you for taking my questions just to clarify the companion diagnostic test being developed.

Mitchell Steiner: Thank you for taking my questions. Just to clarify, the companion diagnostic AR test being developed is the test that you use in our test study to measure AR expression, is that correct? Are there any other currently available tests to measure AR expression levels?

The test that you use in the.

Our test to measure the expression is that correct or are there any other currently available tests to measure <unk> expression level.

Yeah. So let me answer that question. So the question is basically or we use it in your diagnostic tests being developed.

Mitchell Steiner: Yeah, so let me answer that question. So the question is basically, are we using companion diagnostic tests being developed with Roche and Tanna currently to measure angio-receptor expression in the patients entering the ART test study. And the answer is no, we're not. We're using an AR-CLIA test. And what we plan to do during the AR-DR test phase three is to begin to bridge into the commercial test that's being developed by Roche Ventana. This is done often. And so we're using an AR CLIA test versus – CLIA test means it's a laboratory-developed test. It's done with all the controls and everything.

With Roche Ventana currently too.

Two.

Measure.

Andrew receptor expression that patients entering our test study that's question one.

And the answer is no we're not we're using a CLIA test and.

And what we plan to do during the during the <unk>.

Our test.

Phase III.

Is to begin to bridge into the commercial test is being developed by Roche of intent. So this is not unusual this is done often.

And so we're using a CLIA test versus CLIA test means as a laboratory developed test it's done with all the controls and everything is done with the same antibody it's done with it. So it's done the same way, it's not designated commercial tests.

Mitchell Steiner: It's done with the same antibody. So it's done the same way, but it's not designated a commercial test, and not designated as an FDA approved. So we're doing that and bridge into the R-Test study. We have plenty of samples between the R-Test study and the other, three studies that are being done in, you know, the EnABLA study, it's a phase three, and the phase 2B, less than 40s, and so we have plenty of samples, so we feel very, very comfortable that Ventana Roche, who's an expert in developing diagnostic tests, we're not, so if we're having a global diagnostic company do it for us, we'll focus on drug development.

And not designated as an FDA approved test so we're doing that.

And bridge into the RTI study, we have plenty of samples between the artist study than the other.

Three studies that are being done.

Enable is study that's the phase III.

The phase II B.

Less than <unk> and so we have plenty of sample. So we feel very very comfortable that maintain a roche who's an expert in developing the diagnostic tests were not so that's where we're having the global diagnostic company do it for US we will focus on drug development. So the so the short answer the long answer is that yes and no.

Mitchell Steiner: So the short answer, the long answer, is that yes and no. What's going to happen towards the tail of the study is probably, by the time we're in the middle of it all, we will have switched over to the companion diagnostic. And so we'll have plenty of information. As a result, here, and so the concept would be that the AR test would be ready to be submitted to the FDA at the same time we file the clinical data for the Novus study, and interestingly, the same commercial companion diagnostic test can also be used and does not have to be revalidated in other patient populations to be used in the combination studies that we're doing.

And towards the tail of the study is probably by the time, we were in the middle of it all of it would have switched over to the companion diagnostic and so we'll have plenty of information as a result.

So the concept would be.

That the test would be.

Be ready to be file sync submitted to the FDA at the same time, we filed the clinical data for <unk>.

<unk>.

Our test study and interestingly the same commercial the same commercial companion diagnostic test can also be used and not have to be re validated and then the other patient population to be used in the combination studies that we're doing so really this just opens up the companion diagnostics are being used.

Mitchell Steiner: So really, this just opens up the companion diagnostic being used across all of the ARS. An interesting fact is, you know, Vantana Roche, at this point, I think, is doing about 80-85% of the initial testing that's done in breast cancer in a woman, molecularly characterizing the tissue. In other words, you have ER positive, PR positive, progesterone receptor, and HER2 negative. That panel is actually done by Roche.

Across all of the studies.

And you know an interesting fact is maintain a roche at this point I think is doing about 80, 85%.

The initial testing that is done in breast cancer and the woman to molecularly characterize the tissue breast cancer. So in other words, you can do that.

<unk> positive.

Our positive progesterone receptor or two negative that panel is actually done by Roche and so Roche can come in and we had we were able to add this is me dreaming for a moment, we can be in a situation where every woman who know their status from the very beginning.

Mitchell Steiner: And so Roche can come in, and we were able to, and this is me dreaming for a moment. We could be in a situation where every woman will know her AR status from the very beginning. And that would, and then hopefully be a footnote of some sort that, you know, opens up the possibility of NovoSarm being available in the future. So this could be very, very interesting from a market commercialization standpoint. Now, with that said, ER, you know, ER is done by immunohistochemistry as well as estroencephalopathy. And that was grandfathered in.

And that would and then hopefully be a footnote a sensor that opens up the possibility of novus arm could be available in the future.

So this could be very very interesting from a marketing commercialization standpoint.

Now with that said.

No.

E R.

E. R is done by immuno histochemistry as well estrogen receptor and that was grandfathered in so the FDA to have a companion diagnostic for ER.

Mitchell Steiner: So the FDA doesn't have a companion diagnostic for ER. However, HER2 negative, I mean, excuse me, HER2, whether it's negative or positive, is, it does have a companion diagnostic that had to be approved. And so the FDA, when they saw the results that we presented to them for the angio-receptor, they made very clear that, you know, although many laboratories across the world are doing angio-receptor immunohistochemistry in a standard fashion, they require, because it's so important to treat the right women to get the best effect by going after greater than or equal to 40%.

However, her two negative excuse me her too whether it's negative or positive.

Is it does have a companion diagnostic to have to be approved.

So the FDA when they saw with the results that we presented to them for the androgen receptor they.

They made very clear that although many laboratories across the world doing Andrew receptor Immunohistochemistry standard fashion.

That they were they require because it's so important to treat the right women to get the best effect.

Got going after greater than equal to 40% and the flip side is true to that is that we're not seeing we're not seeing the same kind of activity less than forties. They shouldnt be subject to a drug that could provide a benefit.

Mitchell Steiner: And the flip side is true, too, and that is that if we're not seeing the same kind of activity in the less than 40s, they shouldn't be subjected to a drug that's not gonna provide them benefits. And so the FDA took the position that, you know, because this is critical, that it should be a companion diagnosis. So, when we now fast forward... now that we have an approved product in OvisARM, hopefully, then in that situation, the companion diagnostic will be available, AR testing will be done in other laboratories, but the one that will be approved will be the combination of OvisARM and the companion diagnostic. And based on current enrollment status, when do you expect the R-Test study and the Veracity study to complete enrollment? Gary?

And so the FDA took the position.

Because it because this is critical that it should be a companion diagnostic so when do we now fast forward.

Into that we have an approved product and oversight.

And hopefully then in that situation the companion diagnostic would be available. They are testing will be done in other laboratories, but the one that would be approved to be the compounding of the combination of <unk> and the companion diagnostic.

Got it and based on current enrollment status.

When do you expect the arc test study and the rest of the study to complete enrollment.

Gary.

Yes.

Gary Barnett: Yeah, you know, obviously, we're actively working on both of them, and we expect toward the end of 2022, into 2023, that's our target. So we're targeting data readout. And again, this is, you know, we're not trying to guide or anything, but we're certainly targeting data readout sort of by mid-2020. I'm quite frank with both. And they're really close.

Yeah.

As we were on track on both of them and we expect.

Towards the end of 2022.

And the 2023 those are targets, so we're targeting data readout.

This is we're not trying to guide or anything, but we certainly chip targeting.

Data read out in sort of mid 2023 quite frankly for both studies.

Really close.

Got it thank you.

Thank you.

Next question please.

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

Mitchell Steiner: Thank you. Thank you. Next question, please. Our next question comes from Chris Howerton from Jefferies. Please go ahead.

Hey, great. Thanks, so much for taking the questions Mitch I may have missed it but I just was wondering if there was any updated strategy for the F. C. Two business I know there was some thoughts of divestiture.

Chris Howerton: Hey, great. Thanks so much for taking the questions. Mitch, I may have missed it, but I just was wondering if there was any updated strategy for the SC2 business. I know there were some thoughts of divestiture, but obviously, it's been doing pretty well. So that would be one question. And then the follow-up to that would be, could you provide some guidance or some thinking with respect to that business for next fiscal year, please? I'll answer the second question, but first, let me answer the first question.

But obviously, it's been doing pretty well.

That would be one question and then the follow up to that would be.

Could you provide some guidance or some thinking with respect to that business for next fiscal year. Please. Thank you.

I'll answer the second well, let me answer the first question. So you know as we mentioned.

Mitchell Steiner: So, you know, as we mentioned and publicly put out, that we were exploring strategic options for the FC2 business. And strategic options don't always mean that you just go up and sell it off. It means, you know, what's the best way to maximize shareholder value.

Publicly put out that we were exploring strategic options for the for the <unk> business.

Strategic option doesn't always mean that you just go off and sell it off it looks.

Whats the best way to to maximize shareholder value.

And.

Mitchell Steiner: And as I've also said many times, we're not in a rush. We're making lots of money off the product, and it's paying for our development. So it's not like we have to get rid of it or anything. I love the Dan business, but it's, you know, it's, you know, we're just trying to figure out how we can get, you know, instead of a 1 plus 1 equals 0.5, how we can get a 1 plus 1 equals 10.

As I also said many times is that we're not in the rush, we're making lots of money off the product and its paying for part of it is paying for a development.

It's not like we have to get rid of if anything I'd love to Dan business with it.

We're just trying to figure out how we can get instead of a one plus one equals <unk> five that will get a one plus one equals 10.

So we've got very different shareholder base looking at the base business and we have a different shareholder base and their expectations could be pharmaceutical business, but with that said.

Mitchell Steiner: So, you know, we've got a very different shareholder base looking at the base business. We have a different shareholder base and their expectations for the pharmaceutical business. But with that said, what's important to us is we're running a business. And so what we're doing is we're continuing to understand the options that we have for the FC2 business. We're treating the business as if we're never gonna get rid of it so that we make sure we make the right decisions to continue to grow the brand. But at the same time, we're being very opportunistic in understanding what is the best next step for the asset. So stay tuned.

What's important to us as we're running a business and and so what we're doing is we're continuing to understand the options options that we have the FC two business.

We're treating the business as if we're never going to get rid of it so that we make sure we make the right decisions to continue to grow the revenue.

But at the same time, we're being very opportunistic in understanding what's what is the best next step for the asset so stay tune.

As it relates to revenue as I mentioned in our call.

Mitchell Steiner: As it relates to revenue, as I mentioned in Carl, we have put in additional, again, a lot of those lines and are treating it like our own baby. We have put in some additional ways to continue to grow the business. I mean, we're in our fifth year of growth now.

We have put additional get along those lines and treating it like a baby we have put in some additional ways to continue to grow the business I mean, when our 50 year of growth now in this past year, we did a 44% revenue growth and just keeps happening.

Mitchell Steiner: In this past year, we did 44% revenue growth, and this keeps happening. And for some reason, when you start looking at other women's health companies, and we all know many of them that you guys have been following, we kind of blow them away. So it's a stand-alone business with revenues of, you know, for this part of our business, 60, 61.3 million dollars.

And for some reason and when you start looking at other other women's health companies and we all know many of them did you guys have been following.

We kind of blown away, Joe as a standalone business with revenues.

But this part of our business in $60 61 $3 million and.

And most of that revenue, we don't have a sales force. We don't have 100 people, calling on people without putting fancy ads on.

Mitchell Steiner: And most of that revenue, we don't have a sales score. We don't have a hundred people calling people. We're not putting fancy ads on the Super Bowl.

On the Super Bowl and so that means instead of spending that money, we're using that money to <unk> to run our business and to minimize dilution.

Mitchell Steiner: And so that means instead of spending that money, we're using that to run our business and minimize dilution and accelerate the programs so that we, you know, we have become a major player in breast cancer and prostate cancer. And of course, COVID, we think now that the dust has settled and the Omicron variant is here, it reminds us that don't be, you know; it humbles us that this is not going away. As much as business wants COVID to stay or go away so that we can reopen, it looks like it's gonna be tough. I mean, it's scaring people, okay?

And to and to accelerate the programs. So that we know that we have become a major player in breast cancer and prostate cancer and of course Covid. We think we think now that the dust is settled and the omicron variances here. It is remind us that don't be humble.

Humbles us that this is not going away as much as business once COVID-19 to stay or go away and we can reopen it looks like it's going to be tough.

I mean, it's scaring people. Okay. So when you have that kind of fear that means we do not have control.

Mitchell Steiner: So when you have that kind of fear, that means we do not have control. If we don't have control over it, we need to continue doing what we're doing, fighting our way through getting the study done so that if we become an important option, you know, we can move that quickly to patients. Okay, so back to the guidance. So we're putting in a direct-to-patient portal. So that means we have evolved from a purely manufacturer providing to other telemedicine portals to actually having our own portal.

And we don't have control over it we need to we need to continue doing what we're doing is fight our way through getting the study.

Done so that so that if we arent if we become an important option.

We can move that quickly to patients.

So back to go back to the guidance so we're putting in.

Putting in a direct to patient portal. So that means we have evolved from a purely manny.

Manufacturer, providing to other telemedicine portals to actually having their own portal. So that's kind of changed the valuation of the base business instead of being a manufacturer to depends on customers who have their own portals, you'll have our own portal.

Mitchell Steiner: So that's kind of changed the valuation of the base business because instead of being a manufacturer that depends on customers that have their own portals, we all have our own portals. And, you know, our competition out there is the male condom. In the male condom business, the female condom business is about less than 1% of that market share. It is a tremendous blue ocean out there for us.

And.

Our competition out there is the male condom business and the male condom business female condom business is about less than 1% of that market share. It has a tremendous blue ocean out there for us.

And so with that with that size Blue Ocean.

Mitchell Steiner: And so, with that size of Blue Ocean, you know, there's room for a lot of portals to be out there to serve and bring this product forward. And again, you know... Our track record shows there's a market. And we want to feed into that market directly because if the female health business you represent has its own telemedicine portal, that really opens us up to a lot of control over our destiny.

There's room for a lot of portals to be out there to serve.

And to bring this product forward and again.

Our track record shows there is a market.

And.

We want to feed into that market directly because it's the female health business you Rev has its own telemedicine portal.

And that really opens us up to a lot of.

A lot of control over our destiny.

So in the second thing we're doing is to continue to go out there and get additional telemedicine partners. Because every time you turn around there's another female contraception.

Mitchell Steiner: So, and the second thing we're doing is to continue to go out there and get additional telemedicine partners. Because every time you turn around, there's another female contraception internet storefront or pharmacy that's opening up because that is such a big area of need. And because of COVID again, women are not interested in, you know, going to the OB-GYN doctor or the primary care doctor, then having to go walk over to CVS and then have to stand in line and then have to wait for the medicine to come in and, you know, two days, three days later, go back to CVS and then, yeah, just too many steps. They like to push the button like they do for Amazon to get their Pellegrino water and push the button, and it shows up at their front store, you know, on their front step.

Internet storefront or pharmacy, that's opening up because that is such a big area of need and because of Covid again women of noninterest isn't going to the obgyn Doctor at a primary care Doctor then happened to go walk over to the Cvs and then have to stay on the line and then they have to wait for.

Yeah.

The medicine to come in in two days three days later to go back to the Cvs in Nigeria.

Too many steps they'd like to push the button like they do the button for Amazon to get the Pellegrino water.

And pushed the button and it shows up in the front store fronts.

Front step and so so that because of COVID-19.

Mitchell Steiner: And so that, because of COVID, that is the reason why you're seeing such a surge in interest in telemedicine right now because that has really created tremendous convenience, and we tapped right into that. So I think that's a lot of our success. So we think, all I can say about guidance, to get back to your questions, as you know, we don't give guidance, but we do feel that we're going to have a better year in 2020, fiscal year 2022, than we did in 2021. And we had a great year in 2021.

That is the reason why you're seeing such a surge in interest in telemedicine right now because that has really created tremendous convenience and we tapped right into it. So I think that's a lot of our success.

So we think all I can say about guidance and get back to your question is we as you know we don't give guidance, but we do feel that we're going to have better year in 2020 fiscal year 2022 than we did 2021, and we had a great year in 2021.

And so that gives you a sense of some real resources that we can reinvest into our programs and quite frankly, some of those resources that put into continuing to drive robust growth as well.

Mitchell Steiner: And so that gives you a sense of some real resources that we can reinvest in our programs. And quite frankly, some of those resources that we put in continue to drive robust growth. We relate to the sexual health business, and Tassie is in front of the FDA right now, and... We're expecting to hear back this month, and assuming we get approved, you know, we've already moved very, very quickly in creating a telemedicine portal.

It relates to the sexual health business.

And taxi is in front of the FDA right now.

And we.

We're expecting to hear this month.

And assuming we get approved.

Already moved very very quickly and creating a telemedicine portable again separate separate from the female health business to that state.

Mitchell Steiner: Again, separate, separate from the female health business, so that's almost, we treat that like a standalone business. And it's going to, it's going to, and we're partnered with GoodRx, spend three, four hundred million dollars a year pulling people into their site. And we're going to piggyback on that power and take advantage of that because, as you know, BPH is probably one of the main medicines that men will go to for their health, particularly men over the age of 50.

We treat it like a standalone business.

And it's going to it's going to land.

We're partnered with good Rx Goodbye expense, three or $400 million of Youre pulling people into their site and we're going to piggyback on that power and and and.

And take advantage of that because as you know BPH is probably one of the main medicines at men will go and.

Men's health, particularly.

Men over the age of 50.

And so we can tap into that take advantage of such a good Rx didnt even exist three years ago four years ago. So we're dealing with technologies and approaches the selling.

Mitchell Steiner: And so we can tap into that, take advantage of something that could actually exist three years ago, four years ago. So we're dealing with technologies and approaches to selling a product that just didn't exist five years ago, four years ago, and we're tapping right into it with InTest. The other thing we're doing at TASI is we're not going to hire a marketing and sales sales force. We're just not going to go out there and get 100 people out there trying to sell to doctors. COVID doesn't let doctors into offices anymore. I mean, that doesn't let sales people into doctors' offices anymore.

<unk> that just didn't exist five years ago, four years ago, and we're tapping right into the test yes.

The thing we do many taxis with Nokia to hiring the marketing and selling Salesforce. We're just not going to do go out there and get a 100 100 people out there trying to sell the doctor's Toby doesn't let doctors into the offices anymore, I mean doesn't that doesn't what salespeople into doctors' offices anymore and.

And it's just become a new.

Mitchell Steiner: And it's just become a new world. And it's just an expense that we just don't have to spend. I'd rather use that money for drug development. And so with that said, there are opportunities for us also to partner outside the U.S. and in the U.S. with other groups that are going to be interested in helping getting this product out. Kind of like we're doing with FC2.

A new world.

And it just didn't expense that we just don't have to spend I'd, rather use that money for drug development.

So with that said are.

There are opportunities for US also the partner ex U S.

And in the U S.

For other.

Other groups and can be interested in.

Getting this product out kind of like we're doing with FC FC too it's not exclusive to US we've got other very very popular telemedicine a.

Mitchell Steiner: With FC2, it's not exclusive to us. We've got other, you know, very, very popular telemedicine portals that are helping us sell the product. And we're going to kind of do the same thing with Intaspe. Why not?

Portals that are helping to sell the product.

And we're going to kind of do the same thing with <unk> why not.

It's not about trying to be exclusive in the doctor's offices anymore.

Mitchell Steiner: It's not about, you know, trying to be exclusive in the doctor's offices. So I think we're going to have a very good year. Our expectation is that, you know, the second half of the year will be stronger than the first half of the year because, you know, everything will be in place towards the second half of the year. But we're looking for a good year.

So I think we're going to have a very good year.

Our expectation is that.

Is that second half of the year would be stronger than the first half of the year, because everything will be in place towards the second half of the year.

We're looking for a good year.

Okay, well, thank you very much Mitch.

Mitchell Steiner: Okay. Well, thank you very much, Mitch. Thank you. The next question comes from Kumar Raha from Brookline Capital. Please go ahead.

Thank you.

The next question comes from Kumar <unk> from Brookline Capital. Please go ahead.

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

Kumar Raha: Thanks for taking my questions and also congratulations on all the progress. So first, with regard to the COVID-19 trial, what kind of variability are you seeing across the different regions? And do you expect that predominantly these patients are going to have, Yeah, so make sure I understand the first part. So what are we seeing across different regions in terms of strain?

So first with regard to the COVID-19 trial.

What kind of variability are you seeing across the different regions.

And do you expect that predominantly these patients going to how that breaks out radiant.

So it makes you answered the first part so what are we seeing across different regions in terms of strength death.

Death rate of death rates.

Kumar Raha: Death rate. Death rate. Oh, death rate. It's pretty comparable.

It's pretty comparable yeah, Yeah, you know obviously.

Mitchell Steiner: Yeah. Yeah. It's, you know, obviously, we're in the middle of recruitment, and we watch, you know, the blinded data very closely, but we're not seeing anything very, very similar. For instance, very similar mortality rates in the United States versus Brazil.

In the middle of recruitment.

<unk>.

The blinded data very closely but we're not we're seeing very very similar.

For instance, very similar mortality rates in the United States versus Brazil.

Yeah, Yeah, So I would say that that's the that's the reason why the FDA likes to use that as an endpoint because you can't fake a dead end.

Mitchell Steiner: Yeah, so I would say that that's the reason why the FDA likes to use death as an end point because you can't fake a death. And so if a death happens, it's a pretty hard endpoint. And you're not worried about things like, you know, there may be different standards of care in hospitalizations or ICU stays in different countries.

And so the death happens to pretty hard endpoint and you're not worried about things like you know that may be different standard of care in hospitalizations of ICU stay in different countries.

Because they are better or worse, but because you know.

Mitchell Steiner: Not because they're better or worse, but because, you know, if you have to make a decision about who goes into the ICU, you may take somebody out of the ICU that in the U.S. would stay in the ICU because you don't have enough ICU beds and you gotta just ration it, and it has nothing to do with the virus. So that's why DESC is probably the better end point. And when you look at DESC as an end point, it seems to be comparable from region to region.

You have to make a decision who goes in the ICU you may take somebody out of the ICU that in U S would stay in the ICU because you don't have enough ICU beds and you got to just ration is and that has nothing to do the buyers. So that's why deaths copy the better endpoint and when you look at depths of endpoint.

It seems to be comparable from region to region as it relates to the strains.

Mitchell Steiner: As it relates to the strain, interestingly, I saw a recent graph where it looks like the delta strain has become the predominant strain across the world, and so the other ones have kind of gone away. And now the big fear is this Omicron strain is coming in, and it's going to do the same thing. And what's going to be the only reason people are getting scared is because we already know with 30 plus mutations in the spike protein that, and we're already seeing, Regeneron already has, you know, reported.

Interesting I saw a recent graph where it looks like the delta strain has become the predominant strain across the world. So the other ones have kind of gone away.

And now the big fear as this overcome.

Strained as coming in and it's going to do the same thing and what's going on is the only reason people will get scared because we already know with 30 plus mutations in the <unk>.

And the spike protein that we are.

Already seen regeneron already.

Ported.

And some of the other.

Mitchell Steiner: And some of the others; I just saw a recent one with another antibody-directed drug. And, you know, we're gonna see that these monoclonal antibodies go to very specific epitopes on the spike protein. If that epitope, if that spot is changed, the virus, the antibody's not gonna work. And we're seeing that. And so we, you know, it is time for an oral agent that has a more, think of it as sort of a broad-spectrum antibiotic concept, where it's, you know, it's going to have activity in some basic, very well-conserved mechanism, which is how does a virus move from outside the cell into the nucleus, replicate, and get the new virions, the new viruses to come back out of the I mean, that is a highly regulated, highly conserved highway, the microtubules that they use.

I just saw a recent one with another another antibody directed drug.

We're going to see that.

These monoclonal antibodies that go into very specific epitopes on <unk> on the on the spike protein that epitope that spot has changed the virus.

It's not going to work and we're seeing that now and so.

It is time for an oral agent that has a more think of as sort of a broad spectrum antibiotic concept, where it is.

It's going to it's going to it's going to have act.

Activity and some basic very well conserved mechanism, which is how does the virus moved from the outside to sell into the nucleus replicate and gets.

The new variants of new viruses to come back out of the South I mean that is highly regulated highly conserved.

Highway the microtubules.

They use and so whether you're a delta strain, Oklahoma constraint doesn't matter. That's how these that's how it works and that's why I think.

Mitchell Steiner: And so whether you're a Delta strain or Omicron strain, it doesn't matter. That's how they work. So that's why I think, you know, we're in good shape. But we are, you know, as part of determining whether they're COVID positive or not, and we are getting information on what strain the patient has. So we can go back once we get the data set and see whether or not the difference is from strains to strains, which we don't think we'll see. But we are collecting that information. But I would argue that I think most of the strain right now is deltoid.

We're in good shape.

But we are.

Sure.

As part of as part of the.

Determining whether they are COVID-19 positive or not we're getting information on well constrained patient hands. So we can go back once we get the data set and see whether or not there's differences in strange strange, which we don't think we'll see.

But we are collecting that information, but I would argue I think most extreme right now has delta.

Sure.

Okay and with regard to bad thing have you hired labeling discussion and what are your expectation in terms of the local banks.

Mitchell Steiner: Okay, and with regard to TAD, FIN, have you had any labeling discussions, and what are your expectations in terms of the label? Thank you. Okay, in terms of TATS, and so just for the record so people are clear, the FDA has agreed that if we're approved, the trade name will now be TATS. And so, I love Pat Finn, but it turns out that the agency said there's another compound at the agency that could be confusing to use TASFIN. And so, because of that, they asked us to come up with another name.

Okay in terms of attach has been and so just with rates that people are clear.

So the FDA has agreed that the.

<unk> the trade name will now be intensity.

So I'd love to have been but it turns out that the agency said, there's another compound.

The agency that could be confusing to us Tad fan and so because of that they asked us to come up with another name. So we came up with a tax fee.

Mitchell Steiner: So, we came up with a TASFI. And so that's it. As for the agency, what I can tell you at this point is that we are going back and forth with the agency now on label. And so I can't give you a full statement yet in terms of what the label will say. But we're working on that, so stay tuned.

And so so that's it.

As it relates to the agency what I can tell you at this point is we are going back and forth with the agency now on label and so I can't give you a pooled statement yet in terms of what the label will say.

But.

We're working on that so stay tuned.

Thanks, so much.

Mitchell Steiner: Thanks so much. Ladies and gentlemen, this concludes our question and answer session. I'd like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks. Thank you, operator. I appreciate you all joining us today, and I look forward to updating you all on the progress at our next investor call. Thank you. The digital replay of the conference call will be available beginning at approximately noon Eastern time today, December 2nd, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 10161217. Please record your name and company when joining. The conference call is now complete. Thank you for attending today's discussion. [Music]

Okay.

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

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

The digital replay of the conference call will be available beginning approximately noon eastern time today December 2nd by dialing one 870 734 475 to nine in the U S and.

For one excuse me one for 123170088 internationally.

You'll be prompted to enter the replay access code, which will be 101.

61217, please record your name and company when joining the conference call has now concluded. Thank you for attending today's discussion.

[music].