Q3 2021 Veru Inc Earnings Call

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Good morning, ladies and gentlemen, and welcome to the route incorporated Investors' conference call. All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

Operator: Good morning, ladies and gentlemen, and welcome to the Verru Incorporated Investors' conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. And I'd like to turn the conference call over to Mr. Sam Fish, Verroon Corporation's Director of Investor Relations.

After this mornings discussion there will be an opportunity to ask questions. Please note that this event is being recorded I would now like to turn the conference call over to Mr. Sam Fisch the room corporate director of Investor Relations. Please go ahead.

Samuel Fisch: Good morning. The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolio.

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.

Regarding its business operations finances, and development and product portfolio.

Such forward looking statements are subject to known and unknown risks uncertainties and our actual results may differ significantly from those projected suggested or included in any forward looking statements risks risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings.

Samuel Fisch: Such forward-looking statements are subject to known and unknown risks and uncertainties.

Samuel Fisch: 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 to differ materially are contained in our 10

Samuel Fisch: in our 10Q and 10K SEC filings.

I'd now like to turn the conference call over to Dr. Mitchell Steiner.

Samuel Fisch: I'd now like to turn the conference call over to Dr. Mitchell Steiner, who is very excited.

<unk> Chairman CEO and president thank.

Mitchell S. Steiner: Governor, Veruings, Chairman, CEO, and President. Thank you, Sam, and good morning. With me on this morning's call are Michelle Greco, CFO and CAO, Michael Purvitz, EVP, General Counsel, Corporate Strategy, and Sam Fish, Director of Investor Relations. Thank you for joining our call. VIRU is a late-stage oncology biopharmaceutical company with a focus on developing novel medicines for the management of two of the most prevalent cancers, prostate cancer, and breast cancer.

Thank you Sam and good morning with me on this morning's call are Michele Greco CFO and C. E O. Michael purpose, EVP General Counsel corporate strategy and Sam Fisch director of Investor Relations. Thank you for joining our call.

There was a late clinical stage oncology biopharmaceutical company with a focus on developing novel medicines for the management of two of the most prevalent cancers prostate cancer and breast cancer. We're also committed to developing an effective drug therapy to Covid 19, which is a phase III program, we invest cash.

Mitchell S. Steiner: We're also committed to developing an effective drug therapy for COVID-19, which is a phase three program. We invest cash generated from our sexual health commercial business into the clinical development of our potentially high-value oncology and COVID-19 drug candidates. This morning, we will discuss the progress of our late clinical stage prostate cancer and breast cancer drug programs, as well as the Bibisubulin Phase 3 study for the treatment of COVID-19. We will then provide financial highlights for our record third quarter fiscal year 2021.

<unk> from our sexual health commercial business into the clinical development of our potentially high value oncology and Covid 19 drug candidates. This morning, we will discuss the progress of our late clinical stage prostate cancer and breast cancer drug programs as well as the visit Bulent phase III study for the treatment of Covid 19, We will then provide financial highlights.

For a record third quarter fiscal year 2021.

Bureau, anticipates, having four registration clinical trials in prostate cancer breast cancer and for Covid 19, and to potentially registration, enabling clinical trials in breast cancer up and running by the end of the calendar year 2021 for a total of six pivotal potentially pivotal studies to.

Mitchell S. Steiner: Bureau anticipates having four registration clinical trials in prostate cancer, breast cancer, and for COVID-19 and two potentially registration-enabling clinical trials in breast cancer up and running by the end of the calendar year 2021 for a total of six pivotal, potentially pivotal studies. Two of these, the Phase 3 Veracity Study in Prostate Cancer and the Phase 3 COVID-19 clinical study have already commenced. We have been very busy executing.

These phase III veracity study in prostate cancer and the phase III Covid 19 clinical study have already commenced we have been very busy executing on this bold plan and you will see that we're making significant progress.

Mitchell S. Steiner: on this bold plan, and you will see that we're making significant progress. In our prostate cancer clinical program, the company has initiated and is enrolling two clinical trials, the Phase 3 Veracity Study to evaluate Subvisibulin for the treatment of metastatic castration and angri receptor targeting agent-resistant prostate cancer, and a Phase 2 dose-finding clinical study for Vera 100, a GNRH antagonist three-month-long acting depot delivery formulation for angrient deprivation therapy of advanced hormone-sensitive prostate cancer.

In our prostate cancer clinical program. The company has initiated and is enrolling two clinical trials. The phase III veracity study to evaluate <unk> for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer and a phase II dose finding clinical studies severe 100, a gnrh antagonist three month.

Long acting depo delivery formulation with androgen deprivation therapy of advanced hormone sensitive prostate cancer <unk> is an oral first in class new chemical entity that targets cross links and disrupts alpha and beta tubular subunits of microtubules to disrupt decided a skeleton.

Mitchell S. Steiner: Subizubulin is an oral first-in-class, new chemical entity that targets cross-links and disrupts alpha and beta-tubuline subunits of micotubules to disrupt the cytosceles. In prostate cancer, this also results in the disruption of antireceptors transport from the cytoplasm into the nucleus. The phase 1B2 clinical study enrolled 39 men in the phase 1 portion and 41 men in the phase 2 portion. The phase 2 portion is completely enrolled and is still ongoing.

And in prostate cancer. This also results in disruption of Andrew receptors transport from the cytoplasm into the nucleus.

Phase <unk> clinical study.

And well 39 men in the phase one portion and 41 men in the phase II portion of the phase II portion is completely enrolled and it's still ongoing safety so visible and appears to be similar to the androgen receptor targeted agents like abiraterone and <unk> Zulueta mind based on what has been reported in their package insert long term daily chronic drug.

Mitchell S. Steiner: The safety of subisibulin appears to be similar to the angereceptive targeted agents like abraderone enzalutamine based on what has been reported in their package inserts. Long-term daily chronic drug administration appears to be feasible and safe. We have patients in the phase 1B portion that have been on treatment for over two years without evidence of prostate cancer tumor progression. At the recommended phase 2 dose of 63 milligrams, the most common adverse events were mostly grade 1 and 2, diarrhea, fatigue, and nausea. There have been no clinically relevant reports of neutropenia, neurotoxicity, or hair loss.

<unk> appears to be feasible and safe we have patients in the phase <unk> portion that had been on treatment for over two years without evidence of prostate cancer tumor progression.

At the recommended phase two dose of 63 milligrams. The most common adverse events were mostly grade one and two diarrhea fatigue and nausea, there had been no clinically relevant reports of neutropenia neurotoxicity or hair loss.

The phase <unk> study also has yielded promising and significant efficacy outcomes. The efficacy results show PSA declines in responses as well as objective and durable tumor responses, including partial and complete responses with the intent to treat population of all men with measurable disease at baseline which is 29.

Mitchell S. Steiner: The Phase 1B2 study also yielded promising and significant efficacy outcomes. The efficacy results showed PSA declines and responses, as well as objective and durable tumor responses, including partial and complete responses. For the intent-to-treat population of all men with measurable disease at baseline, which is, the objective tumor response rate is 21%. In all men that receive 63 milligrams of a greater dose of subisibulin, which is 55 men, the median radiographic progression-free survival has not been reached, as the study is still ongoing, but it's estimated to be greater than 7.4 months.

The objective tumor response rate is 21% and all men that received 63 milligrams, a greater dose of <unk>, which is 55 men. The median radiographic progression free survival has not been reached as the study is still ongoing but its estimated to be greater than 7.4 months.

We initiated this past quarter the phase threes veracity clinical study, which is an open label two to one randomization study evaluating the efficacy and safety Zambezi should be below 32 milligrams oral daily dosing versus an alternative androgen receptor targeted agent in men with metastatic castration resistant prostate.

Mitchell S. Steiner: We initiated this past quarter the Phase 3 Veracity Clinical Study, which is an open label, 2-1 randomization study evaluating the efficacy and safety of sebizubulin 32 milligrams oral daily dosing versus an alternative angine receptor targeted agent and men with metastatic castration-resistant prostate cancer who have failed at least one antigen receptor-targeted agent but prior to IV chemotherapy. The primary endpoint is median radiographic progression-free survival. The trial assumptions expect a median radiographic progression-free survival of 7.4 months for subisibulin versus 3.7 months for the alternative angin receptor targeted agent, which would represent a doubling in the improvement of median radiographic progression-free survival with subisibuline compared to the active control. The study statistical assumptions to estimate the sample size of 245 subjects included using an alpha of 0.05, a power of 98%, and a dropout rate of 30%.

Cancer, who have failed at least one androgen receptor targeted agent, but prior to IV chemotherapy.

Primary endpoint is median radiographic progression free survival. The trial assumptions, we expect the medium radiographic progression free survival of seven four months push of best places to visit Beulah and versus $3 seven months for the alternative androgen receptor targeted agent, which if achieved would represent a doubling in the improvement of medium range.

Graphic free push that progression free survival and to visit bulent.

<unk> Bill and compare it to the active control study.

Physical assumptions to estimate the sample size of 245 subjects included using an alpha 0.05 power at 98% and a dropout rate of 30%, we expect enrollment to take 10 months recruitment time and 12 months follow up after the last patient is first dose.

Mitchell S. Steiner: We expect enrollment to take 10 months of recruitment time and 12 months of follow-up after the last patient's first dose. Studies are open and enrolling patients in 45 clinical sites across the United States. The lead principal investigator is Dr. Robert Dreiser.

The study is open and enrolling patients in 45 clinical sites across the United States.

<unk> principal investigator is Dr. Robert Dreiser, He's a deputy director at the University of Virginia Cancer Center director of solid tumor oncology and professor of Hematology and oncology.

Mitchell S. Steiner: He's a deputy director at the University of Virginia Cancer Center, Director of Solid Tumor Oncology, and Professor of Hematology and Oncology. In summary, Subisibulin is an oral agent with a novel targeted mechanism of action that, based on scientific literature and package insert, has a similar safety profile as a novel engine receptor. the targeted agent, and Subisubulin has efficacy that is comparable to, if not better than, IV-dozy-taxil chemotherapy in this patient population. Further, chronic oral administration is feasible.

Summary to visit Bulin as an oral agent with a novel targeted mechanism of action that based on scientific literature and package insert has has a similar safety profile as a novel androgen receptor targeted agent and so busy bulent has efficacy at least comparable to if not better than IV docetaxel chemotherapy in this patient population.

Relation further chronic oral administration is feasible, but so far it appears we have met our clinical target product profile goal of having an agent that can be prescribed prior to IV chemotherapy by both urologists and medical oncologists, thus to visit bulent can be potentially a next go to drug to be.

Mitchell S. Steiner: Thus, so far, it appears we have met our clinical target product profile goal of having an agent that can be prescribed prior to IV chemotherapy by both urologists and medical oncologists. Thus, Subvisibulin could potentially be the next go-to drug to be prescribed in the management of men with metastatic castration and angioreceptive targeting agent-resistant prostate cancer. Current global sales for engine receptor targeted agents like Aberraderone, Enzalutamide, and Appaludamide are approaching $6 billion. Unfortunately, all men will develop resistance to these drugs and have prostate cancer progression.

Prescribed in the mandate of men with metastatic castration, and agile receptor targeting agent resistant prostate cancer.

Global sales for androgen receptor targeted agents like abiraterone and dilutive might not pollute the minds are approaching $6 billion.

Unfortunately, all men will develop resistance to these drugs and have prostate cancer progression. This means that the only other option. They will have is to proceed to IV chemotherapy. That's the visibility if approved will address a large part of the metastatic prostate cancer market.

Mitchell S. Steiner: This means that the only other option they will have is to proceed to IV chemotherapy. Thus, subisubulin, if approved, will address a large part of the metastatic prostate cancer market. Next, I will update you on Vero 100, a long-acting androgen deprivation therapy for the treatment of hormone-sensitive and advanced prostate cancer. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment, and it's used as the foundation of treatment throughout the course of the disease.

Next I will update you on zero 100, a long acting androgen deprivation therapy for the treatment of hormone sensitive advanced prostate cancer.

Androgen deprivation therapies currently the mainstay of advanced prostate cancer treatment and this uses the foundation of treatment throughout the course of the disease. Furthermore, androgen deprivation therapy is continued even as other endocrine chemotherapy or radiation treatments are added or stopped standard medical practice for urologists and medical.

Mitchell S. Steiner: Furthermore, androgen deprivation therapy is continued even as other endocrine chemotherapy or radiation treatments are added or stopped. Standard medical practice for urologists and medical oncologists is to administer androgen deprivation therapy every three to four months in their office. These injections coincide with follow-up office visits and imaging assessments for metastatic or advanced prostate cancer. Furthermore, these injections are administered as a buy-and-bill product and are reimbursed under Medicare Plan B, not Plan D. Thus, the urologist is compensated for both the drug and administering the drug. Patients' compliance is 100% once the injection has been administered. Therefore, most physicians strongly prefer injections over oral agents.

Allergist is to administer androgen deprivation therapy every three to four months and they were office. These injections coincide with a follow up office visits and imaging assessments with metastatic or advanced prostate cancer.

Furthermore, these injections are administered as a buy and build product and are reimbursed under Medicare plan B.

<unk> planned D. So the urologists compensated for both the drug and administering the drug patients compliance is 100% once he injection has been administered therefore, most physicians strongly prefer injections over oral agents.

Good attitude opened releasing hormone antagonist treatment. So gnrh treatments versus agonists are preferred because castration occurs rapidly with no surges of flares and testosterone testosterone levels also tend to be lower which is better for tumor control Gnrh antagonists, well also lower F. S H levels.

Mitchell S. Steiner: Gonatropin releasing hormone antagonist treatments of GNRH treatments versus acinus are preferred because castration occurs rapidly with no surges or flares in testosterone. Testosterone levels also tend to be lower, which is better for tumor control. GNRH antagonists also have lower FSA-levels, which is thought to be the reason why there are fewer cardiovascular side effects with GNRH antagonists versus GNRH agony.

Which is thought to be the reason why there were fewer cardiovascular side effects with gnrh antagonist versus Gnrh agonists.

There are no gnrh antagonist depot injection formulations currently approved for treatment beyond a one month duration drew 100 is a novel proprietary long acting peptide three months subcutaneous depot formulation injection designed to address the current limitations of commercially available agents with androgen deprivation therapy.

Mitchell S. Steiner: There are no GNRH antagonist depot injection formulations currently approved for treatment beyond a one-month duration. Vero 100 is a novel proprietary long-acting peptide three-month subcontaneous depot injection designed to address the current limitations of commercially available agents for angrient deprivation therapy. In this past quarter, we initiated and are enrolling a phase two dose-finding clinical study evaluating Vero 100 and 35 in men. We expect to have clinical data to report by year end.

Pete.

And this past quarter.

We have initiated and are enrolling a phase II dose finding clinical study evaluating <unk> 135 men. We expect to have clinical data to report by year end. The open label Phase III registration study, whose design has already been agreed upon by F. D. A.

Mitchell S. Steiner: The open-label phase three registration study, whose design has already been agreed upon by FDA, will evaluate the efficacy and safety of Vero 100 in approximately 100 men with hormone-sensitive metastatic prostate cancer and is expected to start at the end of the calendar year of 2021. Next, I will discuss the progress of our breast cancer program. Vera is planning to initiate the following breast cancer studies during this half of the calendar year.

Evaluate the efficacy and safety of <unk> 100, and approximately 100 men with hormone sensitive metastatic prostate cancer and is anticipated to start at the end of the calendar year of 2021.

Next I will discuss the progress of our breast cancer program.

There is planning to initiate the following breast cancer studies during this half of the half of the calendar year.

<unk> III, our tests clinical study evaluating <unk> monotherapy in a third line metastatic setting in women with ER positive <unk> positive her two negative metastatic breast cancer, who have progressed following yesterdays blocking agents and CDK four six inhibitor.

Mitchell S. Steiner: Phase 3 is a test clinical study evaluating Novosar monotherapy in a third-line metastatic setting in women with AR-positive, ER-positive, her2-negative metastatic breast cancer who have progressed following estrogen blocking agents and CDK-4-6 inhibitors. Phase 2B, a clinical study evaluating a novice arm in combination with Bemisichlib, a CDK-46 inhibitor, in a second-line metastatic setting in women who have progressed following first-line palpulocyclib, a CDK-4-6 inhibitor in combination with an estrogen blocker H, and a Phase 2B clinical study evaluating Subvisibulin monotherapy and Subvisubulin plus Trudevie Monotherapy in women with metastatic triple negative breast cancer that have failed at least two chemotherapy treatments.

Phase two b clinical study evaluating a novus arm in combination of the Burma cyclic CDK <unk> inhibitor in a second line metastatic setting in women who have progressed following first line Powerboats eclipse.

CDK <unk> inhibitor in combination with an estrogen blocking agent.

And a phase <unk> clinical study evaluating <unk> monotherapy and <unk>.

<unk> combination therapy versus <unk>.

Mono therapy in women with metastatic triple negative breast cancer that have failed at least two chemotherapies by way of background. The most common type of breast cancer, which occurs in about 85% of women is ER positive breast cancer, where estrogen is one of the main drivers of proliferation tumor progression and metastasis.

Mitchell S. Steiner: By way of background, the most common type of breast cancer, which occurs in about 85% of women, is ER-positive breast cancer, where estrogen is one of the main drivers of proliferation, tumor progression, and metastasis. Consequently, treatments that target and block the estrogen receptor are the mainstay of breast cancer therapy. According to the 2020 National Comprehensive Cancer Network Guidelines, the recommended first treatment, in a metastatic setting, is either a non-steroidal or romellaumatase inhibitor, in combination with a CDK-46 inhibitor, or phovestrian in combination with a CDK-4-6 inhibitor. The recommended second-line treatment in a metastatic setting is fulvestrian in combination with a CDK-4-6 inhibitor if a CDK-4-6 inhibitor was not used in the first-line metastatic setting.

Consequently treatments at target and block the eastern receptor, where the mainstay of breast cancer therapy. According to the 'twenty 'twenty National comprehensive cancer network guidelines to recommend it first treatment.

In the metastatic setting first line treatment in the metastatic setting is either a non steroidal aromatase inhibitor in combination with CDK four six inhibitor <unk> in combination with CDK four six inhibitor. The recommended second line treatment in the metastatic setting is full best trained in combination with CDK four six but for <unk> inhibitor.

If a CDK four six inhibitor was not used in the first line metastatic setting.

Fortunately almost all women being treated with these regiments will eventually develop resistance to estrogen blocking agents and the CDK four six inhibitor therapies and there are limited clinical data that allow recommendation for a treatment containing another CDK four six inhibitor for these patients alternative treatment approaches that target novel paths.

Mitchell S. Steiner: Unfortunately, almost all women being treated with these regimens will eventually develop resistance to estrogen blocking agents and the CDK-4-6 inhibitors, and there are limited clinical data that allow recommendations for a treatment containing another CDK-4-6 inhibitor for these patients. Alternative treatment approaches that target novel pathways will be required as there are limited treatment options following CDK-4-6 inhibitor and estrogen blocker resistance in the management of ER-positive-HR-2-2-negative metastatic breast cancer. Interestingly, like the estrogen receptor, the antigen receptor is found in over 85% of breast cancer. The antine receptor is a tumor suppressor in estrogen receptor positive breast cancer. This means that when the antine receptor is activated, it strongly suppresses ER-positive breast cancer growth. This explains why, historically.

Ways will be required as there are limited treatment options. Following CDK four six inhibitor, an estrogen blocking agent resistance in the management of ER positive her two negative metastatic breast cancer.

Interestingly like the estrogen receptor. The androgen receptor is found in eight and over 85% of breast cancers. The Andrew receptor as a tumor suppressor in estrogen receptor positive breast cancer. This means that when the androgen receptor is activated strongly suppresses ER positive breast cancer growth. This is Blaine This explains why.

Shortly when synthetic androgens, we used to treat breast cancer. They demonstrated good efficacy, but unfortunately, the masculinizing side effects, such as facial hair acne increase in hematocrit liver toxicity have prohibited their use as a viable treatment in contrast, <unk> an oral first in class.

Mitchell S. Steiner: When synthetic antigens were used to treat breast cancer, they demonstrated good efficacy. But unfortunately, the masculinizing side effects, such as facial hair acne, and an increase in hematate liver toxicity, have prohibited their use as a viable treatment. In contrast, Novosine, an oral first-in-class new chemical entity, is a selective antigen receptor targeted agonist that is being developed for the treatment of AR-positive, ER-positive, hereto-negative, metastatic breast cancer and would represent the first new endocrine therapy for advanced breast cancer in decades.

<unk>, new chemical entity is a selective androgen receptor targeted agonist that is being developed for the treatment of ER positive Europe positive her two negative metastatic breast cancer and would represent the first new endocrine therapy for advanced breast cancer in decades.

<unk> has extensive non clinical and clinical experience hasn't been and valuate. It in over 25 separate clinical studies involving more than 2100 subjects, including five prior phase II clinical studies in advanced breast cancer involving more than 250 patients. In addition to suppressing ER positive <unk> positive breast cancer.

Mitchell S. Steiner: Anobosarm has extensive non-clinical and clinical experience, having been evaluated in over 25 separate clinical studies involving more than 2,100 subjects, including five prior phase 2 clinical studies in advanced breast cancer involving more than 250 patients. In addition to suppressing AR-positive, ER-positive breast cancer cell proliferation and tumor growth, Novosarm has other potential beneficial clinical properties. In pre-clinical studies, Nobosarm has demonstrated that it builds and heals cortical and trabecular bone and therefore has the potential to treat osteoporosis caused by estrogen deprivation and cancer-related events. And Novosarm has also been shown to build muscle and improve physical function.

Cell proliferation and tumor growth in notebooks arm has other potential beneficial clinical properties in preclinical studies <unk> demonstrated that it can that.

That it builds in heels critical trabecular bone and therefore has the potential to treat the osteoporosis caused by the estrogen deprivation and cancer skeletal related events in there.

<unk> has also been shown to build muscle and to improve physical function and clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer patients. Furthermore, because of its tissue selectivity Novus arm has a favorable side effect profile with no magical organization no increase in hematocrit and no liver tox.

Mitchell S. Steiner: in clinical studies involving elderly subjects and patients with cancer coaxia, including breast cancer patients. Furthermore, because of its tissue selectivity, Novus Arm has a favorable side effect profile with no masculinization, no increase in nematicate, and no liver toxicity. Two positive phase two studies involving approximately 150 women with AR-positive, ER-positive, metastatic breast cancer were conducted. The G2-00-802 study was a two-arm study that evaluated 9 milligrams and 18 milligrams of Novosarm daily oral doses in 100,000. 36 women with AR positive, ER positive, and per 2 negative advanced breast cancer.

<unk> two.

Two positive phase II studies involving approximately 150 women with ER positive <unk> positive metastatic breast cancer with conductors.

The G tube zero-zero eight O two phase III study with <unk>.

A two arm study that evaluated nine milligrams and 80 milligrams of <unk> daily oral dosing in 136 women with ER positive <unk> positive for two negative advanced breast cancer.

The patients in the eight O. Two study were heavily pretreated, having failed on average three at an average of three estrogen blocking agents and 88% had received prior chemotherapy.

Mitchell S. Steiner: Patients in the 802 study were heavily pre-treated, having failed on average, an average of three estrogen-blocking agents, and 88% had received prior chemotherapy. In this study, clinically, meaningful tumor responses were observed with Novosan monotherapy, which strongly establishes the relevance of targeting the antireceptor with a selective estrogen receptor agonist and women that were heavily pre-treated with estrogen blocking agents and were resistant, and had AR-positive, The Novosarum appears safe and well-tolerable effects, an increase in hematate or liver toxicity. Quality of life measurements demonstrated overall improvement, including mobility, anxiety, depression, and pain.

In this study clinically meaningful tumor responses were observed with the Novus arm monotherapy and strongly establishes the relevance of targeting the Andrew receptor with a selective Andrew receptor agonists and women that were heavily pretreated with estrogen blocking agents and resistance.

And had a positive ER positive metastatic breast cancer Nova.

<unk> appeared safe and well tolerated without masculinizing effects increase in hematocrit, the liver toxicity quality of life measurements demonstrated overall improvement, including mobility anxiety depression and pain. The nine milligram dose was selected for a phase III study and the 90 milligram cohort compared to the.

Mitchell S. Steiner: The 9-migram dose was selected for our Phase 3 study, and the 9-millimeter cohort, compared to the 18-millimeter cohort, had a similar tumor response but slightly better toxicity profile. Furthermore, and most importantly, we also performed a post hoc subset analysis of this phase two clinical data to evaluate the relationship of the angrin receptor status to novosarm antitumor efficacy. The subset analysis showed that the presence of the angrient receptor and the amount of the antireceptor expression in the breast cancer tissue predicted those women who were more likely to have a positive response to Obosar.

The 80 milligram cohort had a similar tumor responses, but slightly better toxicity profile.

Furthermore, and most importantly, we also performed a post hoc subset analysis.

This phase II clinical data to evaluate the relationship of the androgen receptor status with the Novus arm antitumor efficacy.

Subset analysis showed that the presence of the androgen receptor in the amount of the <unk> receptor expression and the breast cancer tissue predicted those women who are more likely to have a positive response to and oversight more specifically the subset analysis combined randomized subjects in both the nine milligram and 18 milligram cohort.

Mitchell S. Steiner: More specifically, the subset analysis combined randomized subjects in both the 9 milligram and 18 milligram cohorts who had known aneur receptor status determined by a central lab and who had measurable disease, and that was 84 subjects. A cut-off of greater than or equal to 40% AR expression appears to be the best level to enrich for subjects that were most likely to respond to an obo-sarm.

Who had known Andrew receptor status determined by a central lab, and who had measurable disease and that was 84 subjects the cut off of greater than or equal to 40% expression appeared to be the best level to enrich for subjects that were most likely to respond to a nobu sorry, the clinical benefit rate at 24 weeks.

Mitchell S. Steiner: The clinical benefit rate at 24 weeks was 52% at greater than or equal to 40% air-staining versus 14% for less than 40% AR staining, and that P-value was less than 0.004. The best objective tumor response, that is, partial responses plus complete responses, was 34% at greater than or equal to 40% AR staining versus only 2.7% for less than 40% AR staining, and that P-value was less than 0.003. And the median radiographic progression-free survival was 5.47 months at greater than equal to 40% AR staining versus 2.7 months for less than 40% AR staining, and the P value was less than 0.001.

52% at greater than or equal to 40% of our staining versus 14% for less than 40% AAR staining that P value was less than 0.000 for the.

The best objective tumor response, that's partial responses plus complete responses was 34% greater than equaled 40% of our staining versus only two 7% for less than 40% are standing in that P value was less than 0.0003, and the median radiographic progression.

Free survival was five.

$4 seven months at greater than equal to 40% of your standing versus two seven months for less than 40% are staying in that P value is less than 0.001.

Using this 40% cut off 57% of all women with ER positive <unk> positive her two negative metastatic breast cancer would qualify for treatment with <unk>. Thus the presence and the degree of androgen receptor expression in breast cancer tissue was important to put in notebooks arms antitumor activity.

Mitchell S. Steiner: Using this 40% cutoff, 57% of all women with AR positive, ER positive, and her two negative metastatic breast cancer would qualify for treatment with an ovusarm. The presence and the degree of anrogen receptor expression of breast cancer tissue was important for Anobosarm's anti-tumor activity, which is consistent with Anobosarm being a targeted agent or biomarker that could select or enrich for subjects most likely to respond to Anovi

Which is consistent with the notebooks aren't being a targeted age and a biomarker that covid select or enrich for subjects, most likely to respond to <unk> therapy.

As recommended by FDA based on these clinical data <unk> expression status by immuno Kim immuno histochemistry be validated as a companion diagnostic test and is a critical inclusion criterion and our clinical trial design, we're collaborating with a large global diagnostic company, which will in.

Mitchell S. Steiner: As recommended by FDA, based on these clinical data, AR expression status by immunohistochemistry will be validated as a companion diagnostic test and is a critical inclusion criterion in our clinical trial design. We're collaborating with a large global diagnostic company, which will announce when our agreement is complete, that has the expertise to help us with the development and validation of an AR companion diagnostic test in parallel with our face. Our test clinical studies.

Ounce when our agreements complete that has that has the expertise to help us with the development and validation of a companion diagnostic test in parallel with our phase III our test clinical study.

By targeting the Andrew receptor and ER positive metastatic breast cancer and Novus arm introduces a novel Andrew can therapy to patients with breast cancer that have exhausted estrogen blocking agents and CDK four six inhibitors, but prior to IV chemotherapy, we are developing and nobu sharm in two major indications.

Mitchell S. Steiner: By targeting the angin receptor, an ER-positive metastatic breast cancer, Novosarm introduces a novel endocrine therapy to patients with breast cancer that have exhausted estrogen-blocking agents in CDK-4-6 inhibitors but prior to IV chemotherapy. We are developing Obosarm for two major indications in ER-positive-H2-2-negative netostatic breast cancer.

And ER positive her two negative metastatic breast cancer.

First indication is to evaluate and oversaw a monotherapy in a third line metastatic setting we will conduct this phase III. Our test registration study is an open label multicenter multinational randomized one to one active controlled pivotal study evaluating the efficacy and safety of <unk>.

Mitchell S. Steiner: The first indication is to evaluate anobosan monotherapy in a third-line metastatic setting. We will conduct this phase three, our test registration study as an open label, multi-center, multinational, randomized one-to-one, active control pivotal study, evaluating the efficacy and safety of a novice arm 9 milligrams daily oral dose versus an active control. It's either going to be XMS, A plus and minus, ever relimus, or serum, the physician's choice, essentially confirmed greater than equal 40% AR staining, AR-positive, ER-positive, her two negative, metastatic breast cancer subjects who have failed a non-storey eye, professed strength, and a CDK-4-6 neighborhood.

Milligrams daily oral dose versus an active control Z, they're gonna be exemestane, plus or minus ever rely miss or serve to physicians choice.

In centrally confirmed greater than equal, 40% AUR staining ER positive <unk> positive her two negative metastatic breast cancer subjects, who have failed a nonsteroidal AI for restaurant and the CDK four six inhibitor.

The primary endpoint is medium radiographic progression free survival.

Mitchell S. Steiner: The primary endpoint is medium radiographic progression-free survival. Statistical assumptions include an estimated median radiographic progression-free survival of six months for a no-basan monotherapy versus less than three months for the active control. With an alpha of 0.05, 99% power, and a 20% dropout rate, the sample size will be approximately 210 subjects.

Statistical assumptions include an estimated.

Median radiographic progression free survival of six months for <unk> monotherapy versus less than three months for the active control within the alpha of 0.05, 99% power and a 20% drop out rate the sample size will be approximately 210 subjects, we expect to enrollment.

Mitchell S. Steiner: We expect enrollment to take 10 months of recruitment time and 12 months of follow-up after the last patient's first dose. We expect that the companion diagnostic tests will be developed in parallel with the Phase 3R test study with our diagnostic company partner. The Phase 3, our test study, will be conducted in 49 clinical sites across the United States and Europe and is anticipated to commence soon. The second indication to evaluate Nobisarum, plus a CDK-4-6 inhibitor combination therapy in a second-line metastatic setting.

Take 10 months recruitment time, and 12 months follow up after the last patient is first dose we expect that the Andrew receptor companion diagnostic tests will be developed in parallel with the phase III. Our test study with our diagnostic company partner the phase III. Our test study will be conducted in 49 clinical sites across the United States and Europe.

And is anticipated to commence soon.

The second indication to evaluate a nobu sorry.

Plus a CDK four six inhibitor combination therapy in the second line metastatic setting.

We will conduct a phase two b clinical trial to evaluate the efficacy and safety of <unk>, plus a CDK <unk> inhibitor by mistake.

Mitchell S. Steiner: We will conduct a phase 2B clinical trial to evaluate the efficacy and safety of a Novus Arm plus a CDK-46 inhibitor, Bemisiclo, combination versus an alternative angium blocking agent, either for vestrant or non-stero, sorry, for vestrant or a rheumatation inhibitor, and an AR-positive, ER-positive, metastatic breast cancer patients who have failed their first-line therapy, This is an open label.

Combination versus an alternative antigen blocking agent either for restaurant or non steroidal assuming either for veteran.

A rotation inhibitor and in ER positive <unk> positive her two negative metastatic breast cancer patients who have failed their first line therapy, we just constantly Pablo sick with CDK four six inhibitor plus an estrogen blocking agents. This is an open label two.

Two to one randomization clinical study and approximately 186 subjects and is expected to commence in a few months.

Mitchell S. Steiner: 2-1 randomization clinical study in approximately 186 subjects and is expected to commence in a few months. Both of these indications represent large market opportunities, as Palboclip global sales are approaching $6 billion for breast cancer, and unfortunately, almost all of these women will develop resistance to palbolicin and have tumor progression. The goal is to position Nobosarum as the next go-to-attractive option in both the second line and third-line setting for AR-positive, ER-positive, her-2-negative, metastatic breast cancer.

Both of these indications represent large market opportunities as Pablo cyclic global sales are approaching $6 billion in breast cancer and unfortunately, almost all of these women will develop resistance to power about SEC loop and have tumor progression. The goal is to position <unk> as the next go to attractive option.

Both the second line and third line setting with a positive EUR positive her two negative metastatic breast cancer.

Next.

I will update you on the third clinical study in our breast cancer program.

Mitchell S. Steiner: I will update you on the third clinical study in our breast cancer program, a Phase 2B clinical study for chemotherapy-resistant, metastatic triple-negative breast cancer. Metastatic triple negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% of all breast cancer cases. This form of breast cancer does not express the estrogen receptor, progesteroneceptor, or her two, and is resistant to estrogen blocking agents. Thus, the first line of treatment usually consists of multiple systemic chemotherapies, including IV-Taxane chemotherapy.

<unk> clinical study for chemotherapy resistant metastatic triple negative breast cancer.

Metastatic triple negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% involve breast cancers. This form of breast cancer does not express the estrogen receptor progesterone receptor of her two and resistant to estrogen blocking agents. That's the first line of treatment usually consists of multiple systemic chemotherapies, including.

IV Taxane chemotherapy. Unfortunately, almost all of these women will eventually develop resistance and exhibit tumor progression and preclinical studies of human triple negative breast cancer that has become resistant to paclitaxel, which is a taxane to visit bulent significantly inhibits cancer proliferation migration.

Mitchell S. Steiner: Unfortunately, almost all of these women will eventually develop resistance and exhibit tumor progression. Preclinical Studies of Human Triple Negative Breast Cancer that has become resistant to pachlactyl, which is a taxane, ibusibuline significantly inhibits cancer proliferation, migration, metastasis, and invasion, plan to initiate an open-label three-armed phase 2B clinical trial to evaluate the efficacy and safety of oral, subisubulin-tribuline-trolvi combination therapy versus Trudelvey monotherapy in the treatment of approximately 21-16 subjects in a one-to-one-to-one randomization in metastatic triple-negative breast cancer patients who have failed at least two systemic chemotherapies.

Metastasis and invasion.

We plan to initiate an open label three armed phase <unk> clinical trial to evaluate the efficacy and safety of oral <unk> in monotherapy and <unk> combination therapy versus <unk> monotherapy in the treatment of approximately 216 subjects.

In a one to one to one randomization in metastatic triple negative breast cancer patients who have failed at least two systemic chemotherapies. The primary endpoint will be objective tumor response rates or are in human prostate cancer trials chronic oral daily administration should be <unk> and is well tolerated and there was no reports of neutropenia.

Mitchell S. Steiner: The primary endpoint will be objective tumor response rates, O-R-R in human prostate cancer trials. Chronic oral daily administrations abuse of bullin is well-tolerated, and there were no reports of neutropenia. By the way, It will be interesting to see whether subisubulin, in combination with Trudele, could result in less neutropenia with better efficacy, similar to what has been observed in the recently reported successful metastatic non-small cell lung cancer clinical trial with plenibulin and IV colchicine, a site-targeted antitubulin with a similar mechanism as subizibulin in combination with dosytaxy

By the way.

It was it will be interesting to see whether <unk> in combination, which would Delphi could result in less neutropenia with better efficacy similar to what has been observed in the recent recently reported successful metastatic non small cell lung cancer clinical trial with planet Bulin.

And IV culture seeing site targeted antitumor island with a similar mechanism as the visit fueling in combination with Docetaxel prevented the docetaxel induced neutropenia improve.

Mitchell S. Steiner: The docetaxil-induced neutropenia, improved radiographic progression-free survival, and overall survival, even compared to dosi tax. A phase 2B clinical study is planned to commence soon. The clinical development of subisubulin and metastatic breast cancer represents a second major clinical oncology indication for subisibul.

Improved radiographic progression free survival, and overall survival, even compared to docetaxel the.

The phase two B clinical studies planned to commence soon the clinical development of <unk> in the metastatic breast cancer represents a second major clinical oncology indication for <unk>.

Next we will discuss our third clinical program <unk> nine milligrams for the treatment of hospitalized patients with Covid 19, who had high risk for acute respiratory distress syndrome.

Mitchell S. Steiner: Next, we will discuss our third clinical program, Sybizubulin 9 milligrams for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome. Subisubulin in this setting is a novel once daily oral dose small molecule with both broad antiviral and anti-inflammatory activities, which may serve as a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to acute respiratory distress syndrome and death.

<unk> in this setting is a novel once daily orally dosed small molecule.

With both broad antiviral and anti inflammatory activities, which may serve as a two pronged approach to the treatment of Covid 19 virus infection and the subsequent debilitating inflammatory effects that lead to acute respiratory distress syndrome and death.

We conducted a double blind randomized placebo controlled phase II clinical trial evaluating once daily oral dosing of <unk> and 80 milligrams versus placebo and 39 hospitalized Covid 19 patients who had high risk for acute respiratory distress syndrome in the intent to treat population to visit view and reduced <unk>.

Mitchell S. Steiner: We conducted a double-blind, randomized placebo-controlled Phase 2 clinical trial evaluating once-daily oral subisubulin 18 milligrams versus placebo in 39 hospitalized COVID-19 patients who had a high risk of acute respiratory distress syndrome. In the intent-to-treat population, subisibulin reduced the proportion of patients who died during the study from 30% of 6 of 20 in the placebo group to 5.3% 1 of 19 in the subisubulin treated group, and that P-value was 0.04.

A portion of patients who died on study from 30% at six of 20 in the placebo group to five 3% 119 in the <unk> treated group and that P value of 0.044. This is an 82% relative reduction in mortality in the <unk> treated group <unk>.

Mitchell S. Steiner: This is an 82% relative reduction in mortality in the subisubulin-treated group. Sybizubulin also showed significant and clinically meaningful reductions in days in the ICU. Subibulin, on average, is three days versus the placebo of 9.555 days. Subusibulin reduced the days on mechanical ventilation from an average of 5.4 days in the placebo group to 1.6 days in the subisubulin-treated group.

<unk> showed significant and clinically meaningful reductions in days in the ICU to be viewing on average is three days versus placebo 955 days distributions to this view and reduce the days on mechanical ventilation from an average of five four days in the placebo group to one six days in the <unk> treated group <unk> was well.

Mitchell S. Steiner: Subvisibilin was well tolerated with a good safety profile. We're currently enrolling a COVID-19 phase three clinical trial, which is a double-blind, multi-center, multinational, randomized two-to-one placebo-controlled trial, evaluating daily oral doses of 9 milligram subisubulin for up to 21 days versus placebo and 300 hospitalized COVID-19 patients, of which 200 subjects will be treated Subjects in both the subisibule and placebo arms will be allowed to receive standard of care.

Tolerated with a good safety profile with currently.

Enrolling a covid 19 phase III clinical trial, which is a double blind multicenter multinational randomized two to one placebo controlled trial evaluating daily oral doses of nine milligrams of <unk>.

After 21 days versus placebo and 300 hospitalized covid 19 patients.

Of which 200 subjects will be treated with <unk> and 100 subjects will receive placebo who had high risk.

For acute respiratory distress syndrome subjects in both the <unk> and placebo arms will be allowed to receive standard of care. The primary efficacy endpoint will be the proportion of patients who die on study up to day not a day 60 secondary endpoints will include the proportion of patients without respiratory failure days in ICU W.

Mitchell S. Steiner: The primary efficacy endpoint will be the proportion of patients in the Dion study up to day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, the WHO ordinal scale for clinical improvement, change from baseline, days on mechanical ventilation, days in the hospital, and viral loads. Studies are being conducted in the United States, Brazil, Argentina, Mexico, and Colombia.

H O ordinal scale for clinical improvement change from baseline data on mechanical ventilation days in the hospital and viral load the studies being conducted in the United States, Brazil, Argentina, Mexico, and Colombia enrollment is on track to be completed by calendar year end the company has sufficient.

Mitchell S. Steiner: Moments on track to be completed by calendar year-end, the company has sufficient clinical drug supply on hand to complete these phase three clinical studies. We are still seeking funding from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, Barta, and other agencies to try to fund the estimated amount of commercial drug to supply the needs of the United States, assuming confirmatory, positive clinical results, and FDA approval.

Cynical drug supply on hand to complete this phase III clinical study.

We will we still see seeking funding from the biomedical advanced research and development authority of the U S Department of health and human services BARDA and other agencies to try to fund the estimated amount of commercial drug to supply the needs of the United States, assuming confirmatory positive clinical results and <unk>.

<unk> approval.

We believe we have the resources to conduct our plans to visit bulent for Covid 19 phase III without impacting our other cancer drugs clinical development.

Mitchell S. Steiner: We believe we have the resources to conduct our plans for Bisibulin for COVID-19 phase three without impacting our other cancer drugs' clinical development. As you're aware, we're not out of the woods with the COVID-19 pandemic. COVID-19 cases, hospitalizations, and deaths are once again increasing in nearly all states and are fueled by the Delta variant, which is much more contagious than the past versions of the virus. While other variants are still emerging, the highest spread of cases with severe outcomes is happening in places with low vaccination rates.

As you're aware, we're not out of the woods with Covid 19, pandemic Covid 19 cases, hospitalizations and deaths are once again, increasing in nearly all states and fueled by the Delta variant, which is much more contagious and the patch versions of the virus.

The variance are still emerging the highest spread of cases with severe outcomes is happening in places with low vaccination rates Covid 19 infection rates and hospitalizations, a serious level and the CDC is reversing their recommendations back to those used during the peak of the pandemic. There is no doubt we have had a.

Mitchell S. Steiner: COVID-19 infection rates and hospitalizations are at a serious level, and the CDC is reversing their recommendations back to those used during the peak of the pandemic. There is no doubt we have had a major setback in the fight against COVID-19. It is clear that an effective and safe oral therapeutic that can prevent deaths and hospitalized patients with moderate to severe COVID-19 disease at risk for acute respiratory distress syndrome is desperately needed alongside an effective vaccination campaign.

Major setback in the fight against Covid 19, it is clear that in an effective and safe oral therapeutic that can prevent deaths in hospitalized patients with moderate to severe covid 19 disease, who had risk of acute respiratory distress syndrome is desperately needed alongside an effective vaccination campaign.

We strongly believe that <unk> with its anti inflammatory and anti viral properties and its favorable safety profile can be that greatly needed oral therapy based on the strength of these phase II clinical study promising clinical results. The company continues to be duty bound during this persistent global pandemic to pursue.

Mitchell S. Steiner: We strongly believe that Ibizibulin, with its anti-inflammatory and antiviral properties and its favorable safety profile, can be that greatly needed oral therapy. Based on the strength of these phase two clinical studies, promising clinical results, the company continues to be duty-bound during this persistent global pandemic to pursue this COVID-19 indication, even though it's not the primary focus of the company. Finally, I will comment on TadFIN. Tadfin is our combination to Dallafil 5 milligram fanastoride 5 milligram capsule developed to treat lower urinary tract symptoms caused by benign prostate hyperplasia. A combination product contains tadalphil, which is approved for the treatment of BPH and erectile dysfunction, and fanasteride for BPH. The decision date for TADFIN is in December of 2021.

Sue this covid 19 indication, even though it's not the primary focus of the company.

Finally, I will comment on Tat Finn Tad finish our combination to Dallas field five milligram finasteride five milligram capsule developed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. The combination product contains tadalafil, which is approved for the treatment of BPH and erectile dysfunction.

And finasteride for BPH.

<unk> decision date.

<unk> bin is in December of 2021, we plan to launch Tad fan if approved via digital marketing and telemedicine channels and when launch it should be a near term source of additional revenue for <unk> to invest in our promising oncology pipeline.

Mitchell S. Steiner: We plan to launch TadFIN if approved via digital marketing and telemedicine channels. And when it is launched, it should be a near-term source of additional revenue for VIRU to invest in our promising oncology pipeline. Although Ms. Greco will provide the full financial highlights on Viro's commercial segment, which is FC2 and drug commercialization costs, I am happy to report that we've achieved another record quarter and year-to-date. In fact, our nine-month year-to-date revenue increased 48% to $46 million, which has already beat the revenue of $43 million we had for the entire fiscal year of 2020.

Although Ms. Greco will provide the full financial highlights <unk> commercial segment, which is F. C. Two and drug commercialization costs I am happy to report that we've achieved another record quarter.

And year to date in fact on a nine month year to date revenue increased 48% to $46 million, which is already beat the revenue of $43 million, we had for the entire fiscal year of 2020.

Our growing base commercial business, which is now in its fourth year of growth and the prospect of additional growing revenue from F Q2, plus the future revenue from Tad thin places grew on.

Mitchell S. Steiner: Our growing commercial business, which is now in its fourth year of growth, and the prospects of additional growing revenue from FC2, plus the future revenue from Tad Finn, places Veroon on solid financial footing to have the resources to continue to invest in our promising premium drug pipeline for large market opportunities. I will now turn the call over to Michelle Greco, CFO, and C-A-O, to discuss the financial highlights.

Solid financial footing to have the resources to continue to invest in our promising premium drug pipeline for large market opportunities I will now turn the call over to Michele Greco CFO CEO to discuss the financial highlights Michele thank.

Thank you Dr. Steiner as Dr. Steiner indicated we're having another great year in December the company sold three boost for $20 million in February the company completed an equity raise which resulted in a $107.9 million and net proceeds after deducting underwriting commissions and costs and then.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we're having another great year. In December, the company sold pre-boost for $20 million. In February, the company completed an equity raise, which resulted in $107.9 million in net proceeds after deducting underwriting commissions and costs. And in the third quarter, the company achieved record-level net revenues and gross profits related to the sales of FC2. For the first three months of fiscal year 2021, our net revenues were $45.6 million, surpassing $42.6 million in net revenues for the entire fiscal year of 2020. We have already achieved a record year for net revenues versus any prior full fiscal year after only three quarters. Let's start our highlights with the third quarter results for the three months ended June 30th, 2021.

The third quarter the company achieved record level net revenues and gross profit related to the sales of FC too.

For the first three months of fiscal year 2021, our net revenues were $45.6 million, surpassing $42.6 million and net revenues for the entire fiscal year of 2020.

We have already achieved a record year for net revenue versus any prior full fiscal year after only three quarters.

Start our highlights for third quarter results for the three months ended June 30th 2021.

Michele Greco: Overall, net revenues were up 71% to $17.7 million from $10.3 million in the prior year third quarter, due to the growth of our FC2 U.S. prescription business. The company reported significant FC2 sales growth in its prescription business, with net revenues up 150% to $13.5 million from $5.4 million in the prior year third quarter. Gross profit rose 113% to 13.

Overall, net revenues were up 71% to $17.7 million from $10.3 million in the prior year third quarter due to the growth of our FC two U S prescription business. The company reported significant FC to sales growth in its prescription business with net revenue was up 150%.

To $13.5 million from $5.4 million in the prior year third quarter gross profit rose, 13% to $13.9 million or 79% of net revenues compared to $6.5 million or 63% of net revenues in the prior year third quarter.

Michele Greco: $9 million, or 79% of net revenues compared to $6.5 million, or 63% of net revenues in the prior year third quarter. The increase in gross profit and gross margin is driven primarily by increased sales in our USFC2 prescription business. Operating expenses for the quarter increased to $16.7 million compared to the prior year quarter of $7.9 million. Research and development costs were $11.2 million compared to $4.4 million in the prior year quarter due to the commencement of several new phases in our clinical trials.

The increase in gross profit and gross margin is driven primarily by increased sales in our U S. F C. Two prescription business.

Operating expenses for the quarter increased to $16 seven.

$7 million compared to the prior year quarter of $7.9 million research and development costs were $11.2 million compared to $4.4 million in the prior year quarter due to the commencement of several new phases in our clinical trials.

The operating loss for the quarter was $2.9 million compared to $1.4 million in the prior year quarter.

Michele Greco: The operating loss for the quarter was $2.9 million compared to $1.4 million in the prior year quarter. In 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 quarter. As a result, we recorded a reduction in selling, general, and administrative expenses of approximately $420,000, and a reduction to payroll-related research and development costs of approximately $120,000. I will pay $1,000.

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

A big Forgivable loan was treated like a government grant and recognized as a reduction in operating expenses during the quarter. As a result, we recorded a reduction to selling general and administrative expenses of approximately $420000 and a reduction to payroll related research and development costs of approximately 102.

$90000.

Non operating expenses were $2.7 million compared to $1.4 million in the prior year third quarter and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing we entered the synthetic royalty financing during March of 2018.

Michele Greco: Non-operating expenses were $2.7 million compared to $1.4 million in the prior year third quarter and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax benefit of $2.9 million compared to a tax expense of $241,000 in the prior year third quarter.

<unk> for the quarter, we recorded a tax benefit of $2.9 million compared to a tax expense of $241000 in the prior year third quarter. The tax benefit recorded for the quarters, primarily due the increase the value of the U K net operating losses due to an increase in the U K tax rates.

Michele Greco: The tax benefit recorded for the quarters primarily due to the increased value of the UK net operating losses due to an increase in the UK tax rates from 19% to 25%. The bottom line result for the third quarter of fiscal year 2021 was a net loss of $2.7 million, or $3 per diluted common share, compared to a net loss of $3 million, or $0.5 per diluted common share, in the prior year third quarter. Turning to the results for the nine months ending on June 30, 2021.

From 19% to 25% the bottom line result for the third quarter of fiscal year 2021, with a net loss of $2.7 million or three cents per diluted common share compared to a net loss of $3 million.05 per diluted common share in the prior year third quarter.

Turning to the results for the nine months ended June 32021 for the first nine months of fiscal year 2021, total net revenues were up 48% to $45.6 million and $38 million in the prior year period again, a record high for any fiscal year. The company reported growth in <unk> sales.

Michele Greco: For the first nine months of fiscal year 2021, total net revenues were up 48% to $45.6 million from $30.8 million in the prior year period, again, a record high for any fiscal year. The company reported growth in FC2 sales in the U.S. prescription business and in the global public sector. Net revenue from the U.S. prescription business was up 79% to $32.9 million from $18.4 million in the prior year period. Net revenue for the global public health sector business was up 6% to $11.8 million for the nine-month period.

In the U S prescription business and in the global public sector business net revenue from the U S. Prescription business was up 79% to $32.9 million from $18.4 million in the prior year period net revenue for the global public health sector business was up 6% to $11.8 million.

For the nine month period.

Overall gross profit was $35.6 million or 78% of net revenues compared to $21.2 million or 69% of net revenues in the prior year period.

The increase in gross profit and gross margin is due primarily to the increase in the U S prescription business and a decrease in labor transportation and equipment maintenance costs.

Michele Greco: Overall, gross profit was $35.6 million or 78% of net revenues compared to $21.2 million or 69% of net revenues in the prior year period. The increase in gross profit and gross margin is due primarily to an increase in the U.S. prescription business and a decrease in labor, transportation, and equipment maintenance costs. Operating expenses increased by $14.5 million to $39.2 million compared to the prior year period of $24.7 million. The increase is primarily driven by research and development costs, which increased by $10.8 million to $24.4 million from $13.7 million in the prior year period.

Operating expenses increased by $14.5 million to $39.2 million compared to the prior year period of $24.7 million. The increase is primarily driven by research and development costs, which increased by $10.8 million to $24.4 million.

$13.7 million in the prior year period.

Operating income for the period was $14.8 million compared to an operating loss of $3.5 million in the prior year period, an increase of $8.3 million.

Michele Greco: Operating income for the period was $14.8 million, compared to an operating loss of $3.5 million in the prior year period, an increase of $8.3 million. The increase is primarily due to a gain on sale of pre-boost of $18.4 million. Excluding this gain, we had an operating loss of $3.6 million for the period. Non-operating expenses were $5.9 million compared to $3.6 million in the prior year period and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty finance. For the nine-month period, we recorded a tax benefit of $2.8 million compared to a tax expense of $30,000 in the prior year period.

The increase is primarily due to the gain on sale of pre boost of $18.4 million. Excluding this gain we had an operating loss of $3.6 million for the period.

Non operating expenses were $5.9 million compared to $3.6 million in prior year period, and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing.

For the nine month period, we recorded a tax benefit of $2.8 million compared to a tax expense of $30000 in the prior year period. The company has net operating loss carryforwards for U S federal tax purposes.

$42 million with $13.8 million expiring in years through 2040, and $28.2 million, which can be carried forward indefinitely.

Michele Greco: The company has net operating loss carry forwards for U.S. federal tax purposes of $42 million, with $13.8 million expiring in years through 2040, and $28.2 million, which can be carried forward indefinitely. Our U.K. subsidiary has net operating loss carry forwards of $61.3 million and $28,000. million, which did not expire. The bottom line results for the first nine months of fiscal year 2021 were a net income of $11.7 million or 14 cents per diluted common share compared to a net loss of $7.1 million or 11 cents per diluted common share in the prior period. Excluding the gain on the sale of pre-boost, the adjusted net loss was $6.7 million, or $0.9 per diluted common share, in the current period.

U K subsidiary has net operating loss carryforwards of $61.3 million, which do not expire.

The bottom line result for the first nine months of fiscal year 2021, with net income of $11.7 million or <unk> 14 per diluted common share compared to a net loss of $7.1 million or <unk> 11 per diluted common share in the prior period.

<unk> the gain on the sale of peoples. The adjusted net loss was $6.7 million or <unk> <unk> per diluted common share in the current period now.

Now turning to our balance sheet.

As of June 32021, our cash balance was $123.2 million, our accounts receivable were $8.3 million.

Michele Greco: Now, turning to our balance sheet. As of June 30, it's 2021, our cash balance was $123.2 million. Our accounts receivable were $8.3 million. Due to our sale of pre-boost in December, we added $15 million in cash during December and $5 million in notes receivable, which will be collected over the next 10 months. In February, we completed an underwritten public offering of 7,419,354 shares of our common stock at a public offering price of $15.50 per share.

Do our sale of previous in December we added $15 million in cash during December and $5 million in notes receivable, which will be collected over the next 10 months in February we completed an underwritten public offering of 7.419 million 354 shares of our common stock at a public offering.

A $15.50 per share net proceeds were $107.9 million, our net working capital was $137.2 million at June 32021.

<unk> to $12.3 million at September 32020 during the nine months ended June 30th 'twenty 'twenty, one we used cash of $14.8 million for operating activities compared with $1.6 million used for operating activities in the prior period.

Michele Greco: The net proceeds were $107.9 million. Our net working capital was $137.2 million at June 30th, 2021, compared to $12.3 million at September 30th, 2020. During the nine months ended June 30, 2021, we used cash of $14.8 million for operating activities, compared with $1.6 million used for operating activities in the prior period. Overall, we're delighted to see the continued increases in sales in the FC2 business. This revenue source, together with our strong balance sheet, will continue to be the sources 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. Now, I'd like to turn the call back to Dr. Steiner. Thank you, Michelle.

Overall, we're delighted to see the continued increases in sales and the FCC to business. This revenue source together with our strong balance sheet continue to be the sources of funds, we used to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium oncology biopharmaceutical company.

Seeking large market opportunities now I'd like to turn the call back to Dr. Steiner. Thank you Michele our company's fundamentals are strong we have enjoyed another strong and record financial quarter with also another record for U S. <unk> prescription net revenues, which has allowed us to significantly advance our clinical programs based on <unk>.

Year to date performance, we will have a record year in revenue with a robust performance of the commercial business plus the prospects for additional future revenues from Tad thin coupled with our strong cash position. We believe that we will be able to substantially invest in the continued clinical development of our prostate and breast cancer drug pipe product candidate.

Mitchell S. Steiner: Thank you, Michelle. Our company's fundamentals are strong. We have enjoyed another strong record financial quarter with another record for U.S. FC2 prescription revenues, which has allowed us to significantly advance our clinical programs. Based on year-to-day performance, we'll have a record year in revenue.

As well as the visit Bulin Covid 19 phase III clinical study with.

We plan to continue to generate robust growing revenues for our sexual health business.

Mitchell S. Steiner: With the robust performance of the commercial business, plus the prospects for additional future revenues from Tad Finn, coupled with our strong cash position, we believe that we'll be able to substantially invest in the continued clinical development of our prostate and breast cancer drug product candidates, as well as Subvisibul and COVID-19, phase three clinical study. We plan to continue to generate robust growing revenues for a sexual health business. We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company, supported by growing revenue from our cash-generating sexual health business.

We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company supported by growing revenue from our cash generating sexual health business, we have already.

We're already currently enrolling a plan to enroll a total of six pivotal potentially pivotal studies. This calendar year for major indications and large market opportunities to summarize in the prostate cancer clinical program. The company has initiated and is enrolling two clinical trials prostate cancer remains a very <unk>.

Serious cancer as it is the second leading cause of cancer deaths in men.

Mitchell S. Steiner: We are already currently enrolling a plan to enroll a total of six pivotal or potentially pivotal studies this calendar year for major indications and large market opportunities. To summarize, in the prostate cancer clinical program, the company has initiated and is enrolling two clinical trials. Prostate cancer remains a very serious disease, as it is the second leading cause of cancer deaths in men.

<unk> product candidate we are developing over two important indications first via 100, Gnrh antagonist three month depo delivery formulation of androgen deprivation therapy of advanced hormone sensitive prostate cancer has attributes to address the commercial limitations of other androgen deprivation treatment the phase two dose.

In clinical studies enrolling and we expect to report results in the second half of the calendar year and the phase III clinical study has already been accretive upon by FDA.

Mitchell S. Steiner: The drug product candidates that we're developing for two important indications. First, V-O-100, a GNRH antagonist 3-month depot delivery formulation of angrient depovation therapy for advanced hormone-sensitive prostate cancer, has attributes to address the commercial limitations of other androgen deprivation treatment. The Phase 2 dose-finding clinical study is enrolling, and we expect to report results in the second half of the calendar year, and the Phase 3 clinical study has already been approved by FDA and is expected to be initiated shortly thereafter.

Expected to be initiated shortly thereafter, the second major indication of market opportunity takes advantage of the adoption and the widespread use of antigen receptor targeted agents, which have moved very early in the care of advanced prostate cancer almost all men will develop resistance to these drugs and their prostate cancer will progress the market for Andrew.

The androgen receptor targeted agents is approaching $6 billion annually.

We are developing <unk>, an oral agent has the efficacy that appears to be similar if not greater to what has been reported in the literature for chemotherapy, but has side effect profile. That's similar to what has been reported in the package inserts for Andrew receptor targeted agents. This will allow us to visit Beulah and if approved to be prescribed by both urologists and medical oncology.

Mitchell S. Steiner: The second major indication for market opportunity takes advantage of the adoption and widespread use of angin receptor targeted agents, which have moved very early in the care of advanced prostate cancer. However, almost all men will develop resistance to these drugs, and their prostate cancer will progress.

For men after progressing on agile receptor targeted agent, but before IV chemotherapy.

Phase III veracity clinical study to evaluate <unk> for the treatment of metastatic castration and androgen receptor targeted agent resistant prostate cancer is enrolling in the breast cancer program. The company expects to initiate three clinical trials soon breast cancer. We also remains a very serious cancer as it is also the second leading cause of.

Mitchell S. Steiner: The market for androgen receptor targeted agents is approaching $6 billion annually. We're developing subvisibulin, an oral agent that has efficacy that appears to be similar, if not greater, to what has been reported in the literature for chemotherapy, but has a side effect profile that's similar to what has been reported in the package inserts for angioreceptive targeted agents. This will allow subisibulin, if approved, to be prescribed by both urologists and medical oncologists for men after progressing on aneurceptive targeted agents but before IV chemotherapy. A phase 3, Veracity Clinical Study to evaluate Subvisibulin for the treatment of metastatic, castration, and angrient receptor-targeting agent resistant prostate cancer is enrolling.

Cancer deaths in women Europe positive breast cancer occurs and 85% of all breast cancers. The standard care now uses as standard of care now uses CDK four six inhibitor in combination with an estrogen blocking agent in the first and second line metastatic settings, almost all women will become resistant to CDK four six inhibitor and the standard of care.

In this setting is now being defined.

The drugs, we're developing are for two important indications and a positive ER positive breast cancer using companion diagnostic with selecting women have greater than 40 created equal to 40% <unk> standing in breast cancer tissue, which would represent approximately 50% of all women who are positive with metastatic breast cancer.

Mitchell S. Steiner: In its breast cancer program, the company expects to initiate three clinical trials soon. Breast cancer also remains a very serious disease, as it is also the second leading cause of cancer deaths in women. Your positive breast cancer occurs in 85% of all breast cancers.

The first indication for <unk> monotherapy in the third line setting the second indication is a phase two b clinical study that will evaluate <unk> in combination with Burma cycle of the CDK <unk> inhibitor in the second line setting and nobu shine by targeting Inactivating. The androgen receptor represents the first new.

Mitchell S. Steiner: Standard care now uses CDK-4-6 inhibitor in combination with an estrogen blocker in the first and second-line metastatic settings. Almost all women will become resistant to CDK-4-6 inhibitor, and the standard of care in this setting is now being defined. The drugs we are developing are for two important indications in AR-positive, ER-positive breast cancer. Using companion diagnostics, we're selecting women who have greater than 40, greater than equal to 40% AR-standing and breast cancer tissue, which would represent approximately 50% of all women who are ER-positive with metastatic breast cancer.

Hormone therapy in breast cancer in decades for the other 15% of women have triple negative breast cancer, we plan to initiate a phase II clinical study evaluating <unk> monotherapy and it's a busy people in place to Adobe combination therapy versus <unk> monotherapy in women with metastatic triple negative breast cancer, who have failed at least two chemotherapy.

Europe's the goal is to use a <unk> alone or in combination with <unk> will have better efficacy and safety profile, specifically put possible protection against neutropenia.

Then should Lv alone.

Finally, we are enrolling a phase III clinical trial to evaluate <unk> in hospitalized Covid 19 patients who are at high risk for <unk>, we're still in the middle of a global pandemic. The fact is that Covid will be a long war, we have witness evidence of this over and over the Bottomline is that although we have effective.

Mitchell S. Steiner: The first indication for anobosarm monotherapy is in the third line setting. The second indication is a Phase 2B clinical study that will evaluate anobosarm combined with a CDK-46 inhibitor in the second line setting. Inovacarm, by targeting and activating the antireceptor, represents the first new hormone therapy in breast cancer in decades.

Vaccines for now we still need effective drugs to win the war. We have the we have to be have to continue to be steadfast in the execution of our phase III clinical study if we confirm the promising results observed in the completed phase II clinical study, we expect to seek emergency use authorization for this indication we are committed.

Mitchell S. Steiner: For the other 15% of women that have triple negative breast cancer, we plan to initiate a Phase 2 clinical study evaluating subisibulin and monocinisc and Subisubulin plus Trudelele combination therapy versus Trudelevy monotherapy in women with metastatic triple negative breast cancer who have failed at least two chemotherapy treatments. The goal is to see if Sabizabulin alone or in combination with Trudelevy will have better efficacy and Finally, we're enrolling a phase three clinical trial to evaluate subisubulin in hospitalized COVID-19 patients who are at high risk for ARDS. We're still in the middle of a global pandemic. The fact is that COVID will be a long war. We have witnessed evidence of this over and over.

Covid is not going away.

Summary.

We have a portfolio of premium late clinical stage drug candidate products for large global market indications, we expect a stream of steady positive news flow achieving clinical trial milestones and reports of clinical trial data.

We're open to the possibility of a pharmaceutical partnership if it enhances shareholder value and we have a rapidly growing commercial based business, which affords us strategic options with that.

Ill now open the call to questions operator.

Mitchell S. Steiner: The bottom line is that although we have effective vaccines for now, we still need effective drugs to win the war. We have to continue to be steadfast in the execution of our vaccines. or a phase three clinical study. If we confirm the promising results observed in the completed phase two clinical study, we expect to seek emergency use authorization for this indication. We are committed. COVID is not going away.

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

Just a question you May press Star then one on your telephone keypad.

If you are using a speaker phone, we ask that you.

Please pickup your handset before pressing the keys to ensure the best quality to withdraw your question. Please press Star then two please.

Mitchell S. Steiner: In summary, we have a portfolio of premium late-stage drug candidate products for large global market indications. We expect a stream of steady, positive news flow achieving clinical trial milestones and reports of clinical trial data. We are open to the possibility of a pharmaceutical partnership if it enhances shareholder value. And we have a rapidly growing commercial-based business which affords us strategic options. With that, I'll now open the call to questions, Operators.

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, we will pause momentarily to assemble our roster.

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

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

Maybe firstly, just having transformed <unk> into an oncology company and you have a fair amount going on.

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

Do you have any sense of urgency to sell the FCT business just to streamline the company and reinvest those funds and then along those lines.

Any change in thinking about whether you May fund the Covid program yourself.

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 reenter the question queue. Once again, that is star than one to rejoin the question queue. We'll pause momentarily to assemble our roster. Our first question comes from Brandon Folk from Cantor Fitzgerald. Please go ahead.

Given the date, yet well once you see the data thank you.

Yes, Brandon. Thank you very much for both questions. So the first question is you know given that we clearly have.

<unk> transformed ourselves into a oncology company and there's no doubt now with the phase III and the phase <unk> that were on track with two of the major cancers in in areas of large market. So we feel very very good about that.

Brandon Richard Folkes: Hi, thanks for my questions and congratulations on all the progress. Maybe firstly, just, you know, having transformed Vuru into an oncology company, you do have a fair amount going on. So do you have any

But interestingly, we're also with the FCT business, we were looking for strategic options with the strategic options have been most interesting that we're not in a rush to the keyword is you use was urgency so theres no real urgency because look it's generated 45 million.

Mitchell S. Steiner: sense of urgency to sell the FC2 business, just to streamline the company and reinvest those funds. And then, along those lines, Any change in thinking about whether you may fund the COVID program yourself, given the date? You know, well, once you see the data, thank you. Yeah.

Dollars.

The last name.

Mitchell S. Steiner: Yes, Brandon, thank you very much for both questions. So the first question is, you know, given that we clearly have transformed ourselves into an oncology company, and there's no doubt, with the phase 3s and the phase 2Bs, that we're on track for two of the major cancers in areas that are large markets. So we feel very, very good about that. But interestingly, we're also, with the FC2 business, looking for strategic options, but the strategic options have been most interesting in that we're not in them in a rush.

Nine months nine months and if we can stay on track with that same growth.

We're essentially.

Essentially bringing in the amount of money, we need to fund all of our clinical trials.

And so if you look at it that way and you look at the cash in the bank. We raised 107, and we got 120, whatever number 130, we add the accounts receivable was $240 million.

Turning to our cash.

And very interesting position that we're in the driver's seat to see what we wanted to do with the asset So I think.

And by the way strategic options doesn't always mean sell the business. There can be other things that we can do that can enhance shareholders value and have our shareholders get the best of both world. So we're working through that no urgency.

Mitchell S. Steiner: So the key word that you used was urgency. So there's no real urgency because, look, it's generated $45 million in the last nine months. And if we stay on track with that same growth, we're essentially bringing in the amount of money we need to fund all of our clinical trials. And so if you look at it that way, you look at the cash in the bank. We raised 107. We've got 120, whatever number, 130 we had the accounts receiver, almost to 140 million.

And it's not it's not taking our eye off the ball, which is to continue to push and execute on the oncology side.

As it relates to your second question.

I said relating to Covid, 19, and whether or not we're prepared to funded.

After after we.

After we report positive results. So as I've mentioned in my prepared remarks that we have the resources and we have the clinical.

Mitchell S. Steiner: So we're not burning through our cash. So we're in a very interesting position. We're in the driver's seat to see what we want to do with the asset. So I think, and by the way, strategic options don't always mean selling the business. There can be other things that we can do that can enhance shareholder value and allow our shareholders to get the best of both worlds.

Trial supply drug supply, so we're going to be able to run this study without without <unk>.

Losing a beat.

And so we're not dependent on external funding.

For that.

If we have successful data, we're going to be in a very interesting position again, because even though we have.

Mitchell S. Steiner: So we're working through that, no urgency, and it's not taking our eye off the ball, which is to continue to push and execute on the oncology side. As it relates to your second question, what I said relating to COVID-19 and whether or not we're prepared to fund it after we report positive results. So, as I mentioned in my prepared remarks, we have the resources and we have the clinical trial supply, and drug supply. So we're going to be able to run this study without losing a beat. And so we're not dependent on external funding for that.

We have.

To increase the scale up of <unk> because of the multiple trials are going on including Covid 19.

It's a different level of production that you need to do to get ready for the U S population in the world.

With that said.

We will see I mean, I think I think we're at the nine milligram dose you don't need a lot of drug too.

Mitchell S. Steiner: If we have successful data, we're going to be in a very interesting position again because even though we have begun to increase the scale-up of subisibulin because of the multiple trials that are going on, including COVID-19, it's a different level of production that you need to do to get ready for the U.S. population in the world. With that said, you know, we will see. I mean, I think if, you know, we're at a 9 milligram dose, you don't need a lot of drug to begin, and it's only a 21-day treatment, and we can do the treatments at 7-day intervals, so there's a lot of flexibility to try to, quote, spread the drug as quickly as we can.

And it's only a 21 day treatment and we can do the treatment at seven day intervals. So there is a lot of flexibility to try to quote spread.

The drug as quickly as we can but the ideal situation would be just like you saw recently with Merck that.

The government will step in and provide the resources required to scale up so that the drug will be available for the masses.

<unk> outside the U S and so we will continue to move in that direction, because as I said, we've already taken care of the of the resources and the drugs that we need to do the phase III.

But I do think we have positive data.

Given the environment that we're in right now.

Mitchell S. Steiner: But the ideal situation would be, just like you saw recently with Merck, that the government will step in and provide the resources required to scale up so that the drug will be available for the masses, including outside the U.S. And so, you know, we'll continue to move in that direction because, as I said, we've already taken care of the resources and the drugs that we need to do phase three. But I do think we have positive data, given the environment that we're in right now and the fact that, you know, people are so fatigued, but they're also realizing that this COVID thing is not going away. We have not turned a corner, you know. We had this whole discussion that it looked great, everything was opening up, I'm hearing some of the conferences are starting to get canceled again. It just doesn't, and So I do think that the move for funding will change dramatically as people step up to him with positive data.

And the fact that people are so fatigue with it also.

Realizing that this covid thing is not going away, we have not turned the quarter corner.

We had this whole discussion that it looked great everything was opening up I'm hearing some of the conferences are starting to get canceled again, it just wish that guidance and we were only going to windows with a vaccine and a drug. So I do think that the mood for funding will change dramatically as people step in with positive data.

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

Thank you for taking my questions. The first question is.

The.

As the Delta variant in any way affected the enrollment speed.

Okay.

Yeah. So I will tell you what did I tell you what it showed me the answer is yes, and let me tell you why so when we started the clinical trial and you can go back and look at when we said we said we open the Covid 19 phase III the United States.

Yi Chen: The next question comes from Yi Chen from H.C. Wainwright. Please go ahead.

But.

The contribution to the trial enrollment.

Yi Chen: Thank you for taking my questions. The first question:

Yi Chen: The first question is, Has the Delta variant in any way affected enrollment speed?

Became incredibly anemic and the reason became incredibly anemic as because of the rates of hospitalization and deaths kind of just disappeared and I have I have a person that I call. It to each of these emergency excuse me each of these ICU used to see what's happening dismisses crickets now it looks like we blip this thing.

Mitchell S. Steiner: Yeah, so I will tell you what the, I'll tell you what, so the answer is yes, and let me tell you why. So when we started the clinical trial, and you can go back and look at when we said we opened COVID-19 phase three, the United States contribution to the trial enrollment became incredibly anemic. And the reason it became incredibly anemic is because the rates of hospitalization and deaths kind of just disappeared.

And I you know a week ago I got a phone call from him, saying that you're still working on this drives because we're getting slaughtered.

So.

You just have to pick up the newspaper and see that.

It's gone the other way so yes the delta.

Mitchell S. Steiner: And I have a person that I call each of these emergency, excuse me, each of these ICUs to see what's happening because it's crickets now. It looks like we've licked this. And I, you know, a week ago, I got a phone call from him saying, "Are he still working on this drug because we're getting slaughtered?" So, you know, you just have to pick up the newspaper and see that, you know, it's gone the other way.

Correct.

Sure.

The Delta variant is definitely helping us in the U S.

Ex U S. The Delta Varian has already been out there in Brazil, and South America and the Brazilian Varian is there at South America, it's been hit extremely hard and so we're in those countries that continue to look like we did six months ago four months ago, and then on top of that you know that Delta variant is coming we are hearing from side.

Mitchell S. Steiner: So yes, Delta VIII, the Delta variant, is definitely helping us in the U.S. XUS, the Delta variant, has already been out there. In Brazil and South America, you know, the Brazilian variant is there. South America has been hit extremely hard, and so we're in those countries that, you know, continue to look like we did six months ago, four months ago.

Across the world that they are getting ready for the Delta variance, so seeing what happened in the United States and happening in the United States. So.

It's taken on.

Extreme urgency and as I had mentioned before the way that <unk> appeal and works is that it works through.

Mitchell S. Steiner: And then on top of that, you know, the Delta variant is coming. We're hearing from sites across the world that they're getting ready for the Delta variant. So they're seeing what happens. happened in the United States and happening in the United States.

<unk> microtubules and microtubules or responsible for pulling the virus from the surface into the nucleus, where the Corona virus can replicate and then once it makes new viruses. The viruses have to be brought to the outside of the cell and released and our drug works by.

Mitchell S. Steiner: So it's taken on an extreme urgency. And as I mentioned before, the way that subesibulin works is that it works by interrupting the microtubules. And microtubules are responsible for pulling the virus from the surface into the nucleus where the coronavirus can replicate. And then once it makes new viruses, the viruses have to be brought to the outside of the cell and released. And our drug works by interrupting that, again, the microtubules, which are required to, you know, like a highway to bring the virus to the outside of the cell and release it. So we don't care whether it's a blue car or a green car or a bus or a truck. The highway is gone.

Interrupting that again, the microtubules, which are required to.

Like a highway to bring the virus to the outside the cell and release. It. So we don't care, whether it's a blue car green car or bus or truck the highways gone.

Youre not going be able to move really in and out.

So we're comfortable that we're not going to have an issue like it is very specific antibody or a vaccine against the variance.

And so I think that is going to be the major strength of our compounds. So whether delta variance Atlanta variant with some of these other variants that are coming through.

Mitchell S. Steiner: You're not going to be able to move freely in and out. So we're comfortable that, you know, we won't have an issue like a very specific antibody or a vaccine. against the variance. And so I think that's going to be the major strength of our compound. So whether a delta variant or a lambda variant or some of these other variants that are coming through, it should not matter. And so I think that puts us on, you know, good footing to, again, if we replicate the phase two results, to have, you know, a broad spectrum type of product.

It should not matter and so I think that puts us in good footing to if we get if we can replicate the phase II results.

Have an effective broad.

Our broad spectrum type of.

Product.

Got it and then also serve as uplink should perform the same.

Those patients that got Covid 19, regardless, whether they are estimated or invest in it is that correct, yeah, but but in fairness in fairness is a good question in fairness, it's you know and again.

Mitchell S. Steiner: Got it. And then also, Sub-Explink should perform the saying among those patients that get COVID-19, regardless whether they are vaccinated or unvaccinated. Is that correct?

We're staying very very close to this because we're in the middle of this war so to speak.

If youre vaccinated you tend to have a more mild outcome and so yes, you are seeing the strange breakthrough.

Mitchell S. Steiner: Is that correct? Yeah, but in fairness, in fairness, it's a good question.

Mitchell S. Steiner: In fairness, it's, you know, and again, we're staying very, very close to this because we're in the middle of this war, so to speak. If you're vaccinated, you tend to have a more mild outcome. And so, yes, you're seeing these strange breakthroughs, and what's happening is that the unvaccinated are the ones that are really bearing the brunt of this particular part of the pandemic. And so if you're unvaccinated, then the Delta variant, you're going to get it, and you're going to get it quickly, but still, it's the same situation, age, comorbidities, and the whole bit.

What's happening is that the unvaccinated wanted it really bearing the brunt of this particular part of the pandemic and so if youre unvaccinated, the delta variance youre going to get it and they're going to get it quickly, but still it's the same situation age comorbidities and the whole bit.

And even though we're hearing that.

Lots of young people are starting to show up because they didn't get vaccinated.

That half the half. These ICU use are filled with people that are still older age that didn't get vaccinated. So it's going to be plenty of.

People that we can try to help through our clinical trial, but more importantly confirm with our clinical trial is.

Mitchell S. Steiner: And even though we're hearing that a lot of young people are starting to show up because they didn't get vaccinated, you know, about half these ICUs are filled with people that are still older who didn't get vaccinated. So there are going to be plenty of people. that we can try to help through our clinical trial, but more importantly, confirm whether our clinical trial is, you know, going to support, or whether it is going to replicate what we saw in phase two. So that's what I would say about the Delta variant.

I'm going to support clinical trials going to replicate what we saw in phase II.

So.

So that's what I would say about the Delta variant.

Got it.

Does does has slowed down the enrollment for the phase III Crosby accounts with 12.

No we have not seen that interestingly and I had made this comment before that with cancer patients cancerous scared I mean cancer metastatic, it's spreading and so people are scared well we did see.

Mitchell S. Steiner: Does it slow down the enrollment for the phase 3 crusty cancer trial?

The first half when we had the phase <unk> in a phase II ongoing is we did have a few patients that got a little bit nervous about coming into the hospital to get their scans. So they're already in the trial was enrolled but they kind of got a little delay here and there and when we actually looked with a C T scan or an MRI, but that was more of a rare <unk>.

Mitchell S. Steiner: No, we have not seen that. Interestingly, and I had made this comment before, that with cancer patients, you know, cancer is scary. I mean, cancer, it's metastatic, it's spreading, and so people are scared. What we did see in the first half when we had phase 1b and phase 2 ongoing was that we did have a few patients that got a little bit nervous about coming into the hospital to get their scans. So they were already in the trial that was enrolled, but they kind of, we got a little delay. Here and there when we actually looked with a CT scanner or an MRI, but that was more of a rare instance.

And mostly most people stayed on track and and so now I can tell you that the visa bulent phase III is open and enrolling and we're smack on target if not a little ahead of target in terms of enrollment. So so far we have not seen that problem and then get back to your point before about covid.

Mitchell S. Steiner: Most people stayed on track. And so now I can tell you that Visibulance phase three is open and enrolling, and we're smack on target, if not a little ahead of target in terms of enrollment. So far, we have not seen that problem.

<unk>. There's no question, we're getting a lot of inbound interest for sites in the U S where before it as I said it was crickets, we couldnt nobody was calling is nobody's nobody was returning our calls but thats changed.

Mitchell S. Steiner: And then get back to your point earlier about COVID-19, there's no question we're getting a lot of inbound interest for sites in the U.S. Where before, as I said, it was crickets. We couldn't, you know; nobody was calling us. Nobody was returning our calls.

Dramatically and so so you know we're hoping that this will this will get us to the finish line in terms of enrollment.

Got it thank you.

Thank you.

The next question comes from Kumar Roger from Brookline Capital markets. Please go ahead.

Mitchell S. Steiner: But that's changed, you know, dramatically. And so, you know, we're hoping that this will get us to the finish line in terms of involvement.

Thanks for taking my questions.

So with regards to the completion of enrollment by the end of the year for the Covid 19 trial.

Mitchell S. Steiner: Got it. Thank you. Thank you. The next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead. Thank you.

Does that take into consideration the recent uptick in cases.

And also income salt.

Kumar Raja: Thanks for taking my questions. So with regard to the completion of enrollment by the end of the year for the COVID-19 trial, does that take into consideration the recent uptick in cases? And also, in terms of dosing either orally or by the nasal route, did you see any difference in efficacy based on how the drug is being administered?

Dosing either orderly ordered by the natural gas to route did you see any difference in efficacy based on how the drug is being administered.

Right to make sure so the.

I'll answer the second question first so you were asking that which are busy bulin in covid 19, being a capsule or we're finding some problems administering the drug in the ICU setting.

Mitchell S. Steiner: Right, so I'm going to answer the second question first. So you're asking, because it's a bisobulin in COVID-19 and it's a capsule, are we finding some problems administering the drug in an ICU?

It looks like they can be either administered orally or using the natural gastric tube. So yes, yes, yes, exactly so from that standpoint, we have not seen any problem because we're there.

Kumar Raja: It looks like they can be either administered orally or using a nasogastic tube. Yes, yes, exactly. So from that standpoint, we have not seen any problem because patients need to get their medicines. And so because it's a capsule, it's a powder in the capsule, we've had no problem with administering it either orally or through an NG tube.

Patients need to get medicines and so we've.

Because it's a capsule into powder in the capsule.

We've had no problem with administering either orally or through an <unk>. So that's been fine.

Mitchell S. Steiner: So that's been fine. As it relates to your question about the uptick and meeting our goal, In other words, we said we'd get this thing filled by the year end and then went quiet in the U.S. So I must admit we were getting nervous because we have to have a certain U.S. component, and it went away. But now we're not nervous anymore because the U.S. is gone. I mean, just look at the numbers.

As it relates to your question about the uptick in meeting our goals in other words, we said we'd get this thing filled by year end and and then went quiet in the U S. So I must admit we were getting nervous.

Because we have to have a certain U S component and it went away.

But now we're not nervous anymore, because the U S has gone I mean, just look at the numbers that I was 108000, new cases on average daily in the hospitalizations are picking up in two weeks after that.

Mitchell S. Steiner: It was 108,000 new cases on average daily, and the hospitalizations are picking up. And two weeks later, the deaths will start picking up. And so it's just, I mean, we've gotten to a point now, now entering the fourth wave, that we can always predict what's going to happen.

The deaths will start picking up and so it's just I mean, we've gotten to a point now now entering the fourth wave that we can always predict.

What's going to happen and it's not it's not.

Mitchell S. Steiner: And it's not, it's not, you know, other than the vaccinated patient, the unvaccinated patient is kind of following the playbook. So I would say because of the uptick in cases that we're more likely to reach our goal. Okay, and with regard to Saba, Boulin, as well as, you know, Bassem, with regard to Europe, what's happening in that front, and also you talked, you know, touched on a little bit about, you know, pharmaceutical partnerships. So how should we think about that? Would it be like, you know, just like partnership for Europe or, you know, maybe a little bit of Colorado? Yeah, sure. So we're

Other than the vaccinated patients the unvaccinated patients is kind of following the playbook.

So I would say because of the uptick in cases that we're more likely to reach our goal.

Okay.

With regards to the scientists are building now.

With regard to Europe.

What's happening in that front and also you talked a little bit.

A little bit about pharmaceutical partnerships.

So how should we think about it would be like you know just like partnership part of Europe part of it maybe a little bit of color on that.

Yeah sure. So we're fortunate that we're going to be in a position in both our breast cancer and prostate cancer programs to be in phase III.

Mitchell S. Steiner: Yeah, sure. So we're fortunate that we're going to be in a position in both our breast cancer and prostate cancer programs to be in phase three. And because you're in phase three, the question then becomes, you know, how are you viewing partnerships? And as you know, the back of the envelope would say that if you piecemeal the relationships, then it will decrease the value of the opportunity for a global partner. And so what we're trying to do is, first of all, you know, take a step back. Subisubulin prostate, we're only running in the U.S. And Inobosarm, Phase 3, are test studies being done in the U.S. and Europe.

And because you are in phase III. The question then becomes how are you viewing partnerships.

And and as you know the the back of the envelope would say that if used piecemeal the relationships and it will decrease the value of the opportunity for a global partner.

And so what we're trying to do it.

Is is first of all and then take a step back it's a bit of bulent prostate will only running in the U S and.

And the <unk> phase III, our test studies being done in the U S and Europe.

Mitchell S. Steiner: And we're also in the process of beginning to have some of the EMA discussions that we will need. And as you know, EMA and with Brexit and everything, we have to understand Britain. So that's gotten a little strange.

And we're also in the process of beginning to have some of the EMA discussions that we will need and as you know EMA.

With Brexit and everything else understand Britain, so that's gotten a little strange, but our position right now is to execute on the trial. The trials are open label, which means that.

Mitchell S. Steiner: But our position right now is to execute on the trial. The trials are open label, which means that we have a GSMB that can look at this and we can continue to execute. But I think the most important thing for us to do is get these things filled and execute on them. We are in constant discussions with large farmers, medium-sized farmers, and small farmers across all our programs.

We have a <unk> that can look at this and we can that we can continue to execute but I think the most important thing for us to do is get these things build execute on them. We are in constant discussions with large pharma medium sized pharma small pharma across all our programs.

And but I think the way we're thinking of it the biggest value that we're going to have the shareholders is to see if we can couple the good phase II data with some some some good phase III data, where some promise of phase III data because it's open label and that's to me that that that feels like that's going to get is the best.

Mitchell S. Steiner: But I think the way we're thinking of it, the biggest value that we're going to have as shareholders, is to see if we can couple the good phase two data with some good phase three data or some promise of phase three data because it's open label. And to me, that feels like that's going to get us the best value. We have the resources thanks to our shareholder support, and we have the resources because of our base business.

<unk>, we have the resources, thanks to our shareholder support and we have the resources because of our base business. So I think we're in a very unique position that we can wait it out to get the best position and get the best deal.

Mitchell S. Steiner: So I think we're in a very unique position. We can wait it out to get the best position, and I get the best deal. But I do believe that, you know, at some point, some of our programs are going to be best served by a pharmaceutical relationship, particularly on the commercial side. And so we're doing exactly as you would expect us to do, and that is having discussions with the largest and the smallest, the biggest, not the smallest, the biggest, and the medium, the biggest for global and the medium for piecemeal. And but our preference is to keep the dialogue going till we get an offer we can't refuse.

So, but I do believe that you know at some point.

Some of our some of our programs are going to be best served with a pharmaceutical relationship, particularly.

Particularly on the commercial side and so so we're you know we.

We're doing exactly as you would expect us to do and that is having discussions with the largest and the smallest largest not the largest in the medium largest very global in the medium for piece mealing. It.

But but our preference is to keep the dialogue going until we get a get an offer we can't refuse.

Operator: The next question comes from Chris Howerton from Jeffries. Please go ahead.

Thanks, so much.

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

Yes.

Chris Howerton: Hey, good morning. Thanks so much for taking the questions, Mitch. I guess,

Hey, good morning, Thanks, so much for taking the questions Mitch I guess just two for me first on the <unk>.

Chris Howerton: Just two for me first on the, you know, the FC2,

You know the FCC to obviously great to see the continued growth on that program I guess I am curious if you could provide a little color as to.

Chris Howerton: Obviously, you know, great to see the continued growth on that program. I guess I'm curious if you could provide a little color as to what is driving that growth currently and what the expectations are going into the second half of the year. Perhaps like there's some seasonality to the trends that you might expect for contraception that would be helpful for us to know about. So that's one question. And then the second question, I guess maybe I missed it, I'm just wondering when we might expect the phase two portion of the ongoing study in prostate cancer.

What is driving that growth currently and what is the expectations going into the second half of the year.

Perhaps like there is some seasonality to the trends that you might expect for contraception that would be helpful. For us to know about so that's one question and then the second question I guess I, maybe I missed it but I'm just wondering when we might expect.

Phase two portion for the.

The ongoing study in prostate cancer.

Mitchell S. Steiner: Great. So the first question had to do with, you know, can we give you a little bit more color in terms of FC2 growth? And I will tell you, there is no seasonality.

Great. So the first the first question has to do with can.

Can we give you a little bit more color in terms of FC to growth and I will tell you. There is no seasonality and as you can tell it's also completely covid 19 resistant.

Mitchell S. Steiner: And as you can tell, it's also completely COVID-19 resistant. So the growth is being driven by, and this is the beauty of it, we have telemedicine partners that are using their resources to market and sell and bring women seeking birth control to their websites, the storefront. It's an incredibly powerful way to go out there and market and sell because if we look at the number of FTEs that are supporting our U.S. business, it's like three or four.

So and so the growth the growth is being driven by.

By initiative beauty of it we have telemedicine partners that are using their resources to market and sell and bring.

Women seeking birth control to their websites storefronts, it's an incredibly powerful way to go out there and market and sell because if we look at the number of Ftes.

Supporting our U S business, it's like three or four.

Mitchell S. Steiner: And, you know, that's generating, you know, $30, $35 million if you take out the U.S. public sector and the global public sector. And so it's incredibly efficient for a company like ourselves, because then we can use those resources to put back into the company. Now, with that said, where we see growth taking place is that we're also seeing that there's a very, very healthy reorder rate for telemedicine, and so it's not, you know, yes, there's a big blue ocean, and people are starting, but they're coming back, and the reorder rate is very, very healthy. As you know, that will help the numbers from the next. From a financial standpoint,

And that's generating you know.

30, $30.35 million.

If you take out U S public.

Global public sector.

So yes it.

It is incredibly efficient for a company like ourselves because then we can use those resources.

Put back in.

Into the company now with that said, where we see the growth taking place is we're also seeing that there is a very very healthy reorder rate.

With a telemedicine so it's not yes, it's a big Blue Ocean and people are starting.

But they're coming back.

And the reorder rate is very very healthy as you know that will help the numbers from an exponential standpoint also we are in discussions with other telemedicine groups that are focused on birth control and because this area is growing new ones are showing up.

Mitchell S. Steiner: Also, we're in discussions with other telemedicine groups that are focused on birth control. Because this area is growing, new ones are showing up periodically that we've engaged with, and hopefully, you know, hopefully we'll pick up a few more of those. Every time we pick up a few more of those, it really increases the number of prescriptions that we're able to have. And then finally, we're going to look for other ways that we can take advantage of digital and internet channels to sell. And so we've been very, very pleased. And, you know, the global public sector did fine. It was flat.

Periodically that we've engaged with and hopefully hopefully we'll pick up a few more of those every time, we pick up a few more of those that really increases the number of prescriptions that were able to.

Oh half.

And then finally.

We're going to we're going to look for other ways that we can take advantage of digital.

And internet channels to sell and so we've been very very pleased and as you know.

The global public sector.

Mitchell S. Steiner: It was a little bit more than flat. But, boy, I think you're going to see all of the growth driven primarily by the U.S. prescription business. And the ratios have flipped where, you know, it used to be all public sector, then with a little bit of U.S. prescription drugs, now it's going to, you know, from a revenue standpoint, from a profit standpoint, it's all going to be primarily U.S. And so I'm happy to report that. We do believe we're going to have a pretty good year. I mean, this is where we're entering, you know; we're four years into it. We're entering our fifth year of growth. And, you know, go look.

Did fine it was flat it was a little bit more than flat, but boy. The U S. I think youre going to see all of the growth driven primarily by the U S prescription business and the ratios have flipped where it used to be all public sector, and then with a little bit of.

U S prescription now it's going to from a revenue standpoint from a profit standpoint, it's all going to be primarily U S and so I'm happy to report and we do believe we can have a pretty good.

Year I mean, this is where we're entering we're four years into it we are entering our fifth year of growth.

Go look at it just seems to be the same rate and that's very good for us because if we can maintain that then we're paying for our clinical trials.

Mitchell S. Steiner: It just seems to be the same rate. And that's very good for us because if we can maintain that, then we're paying for our clinical trials. And so, you know, that's, and keep some real cash in the bank and not touch it.

And so that's the end.

It keeps some real cash in the bank and not touch it. So this is.

Mitchell S. Steiner: So this is, you know, so that we can, you know, accelerate and stay on track. And we can, you know, we can also look at a big pharmaceutical partner and say, look, you're not going to weigh this out. You know, if you're going to give us a deal, give us the best deal possible.

So that we can.

Accelerate and stay on track and we can do.

And also look at our big pharmaceutical partner and say look you're not going to wait us out.

If you're going to give us a deal give us give us the best deal possible.

I think it's put us in good position so to give you color. There's no seasonality covid 19 is not affecting the growth.

Mitchell S. Steiner: So I think it's put us in a good position. So to give you some color, there's no seasonality, COVID-19 is not affecting the growth. Then, you know, we're actively involved in business development to get additional telemedicine groups on board. And we also have a few things that we're doing to also enhance that. So the business is growing, happy to report.

The.

We're actively involved in business development to get additional telemedicine groups on board and we also have a few things that we're doing to also enhance that so the business is growing.

To report the second question you asked has to do with the ongoing phase two.

Mitchell S. Steiner: The second question you asked has to do with the ongoing phase two, you know, the ongoing phase 1B, it's completed, but we still have a couple of patients that are beyond two years old, so that study is still going on. And in phase two, we still have patients on it. And so I think what will happen is by year end, we'll be able to provide more color because the longer we wait with these patients, the more accurate we're going to get in terms of understanding the medium progression-free survival and some of the other data.

The ongoing phase one b, it's completed but we still have a couple of patients that are beyond two years. So that study is still going on and in the phase II, we still have patients on it.

So.

I think what will happen is by a.

At year end, we will we'll be able to provide more color.

Sure.

The longer we wait with these patients.

A more accurate that we're going to get in terms of understanding the median progression free survival.

And some of the other data so the phase III is up and running urologists and medical oncologists are excited about the data they have seen so far.

Mitchell S. Steiner: So phase three is up and running, and urologists and medical oncologists are excited about the data they have seen so far. We've reported updates, and the updates are consistent. that the agent has activity. And in prostate cancer, that's why we're excited to expand it into triple negative breast cancer because the preclinical data that we saw in prostate cancer showed that we would have an effect on prostate cancer with no nutropenia and neurotoxicity. That played out clinically.

We've reported updates.

The updates are consistent that the agent has activity.

And in prostate cancer, that's why we're excited to expand it into triple negative breast cancer, because the preclinical data that we saw in prostate just showed that we would have an effect on prostate cancer with no neutropenia neurotoxicity that played out clinically and then we also have data in triple negative breast cancer.

Mitchell S. Steiner: And then we also have data in triple negative breast cancer that should also translate clinically. And it'll be interesting to see how that plays out when we go into our second major indication. So I would say look for data for the phase two subbesobulant portion of the prostate cancer study, you know, towards the end of the year.

It should also translate clinically and and it'll be interesting to see how that plays out when we go into our second major indication. So I would say look for data.

For the phase III.

So these are bulent.

Portion.

Of the prostate cancer study.

Chris Howerton: That's great. Okay, thanks, Mitch. And I guess, you know, I think we've discussed this in the past.

Towards the end of the year.

That's great. Okay. Thanks, Mitch and I guess I think we've discussed this in the past, but maybe if I can ask is is there any information that you anticipate learning from either the ongoing things wouldn't be obviously the longer term follow up or within the phase II patients that would.

Chris Howerton: but maybe if I can't ask, is there any information that you anticipate learning?

Chris Howerton: from either the ongoing phase one be obviously the longer term follow-up or within

Chris Howerton: or within the phase two patients, that would any way change your current phase three plans, or do you feel pretty solid about those phase three designs? I think we feel very solid about the phase three design. I think the reason we're continuing is because if I were to tell you that on average, these patients are failing at three months, three and a half months, with an alternative, Andrew and we said the targeted agent, and we've got some patients that, you know, in phase 1B, you know, 12 months, and now heading it to, you know, that's pretty good.

Any way change your current phase III plans or do you feel pretty solid about those phase III designs at this point.

I think we feel very solid about the phase III design.

Thank the region was continuing as because if I would've told you that on average. These patients are failing at three months three and a half months with an alternative antigen receptor targeted agent and we've got some patients.

And the phase <unk> B.

12 months and now we're heading into two years, you would say that's pretty good.

But that doesn't change our phase III design and then the phase III.

Chris Howerton: But that doesn't change our phase three design. And then phase two is also providing us with information that we use to help the trial design assumptions and understand the PFS and that kind of stuff. So I would say that we learned what we needed to learn from phase 1B and phase 2. That's the reason we went to phase 3 because we felt at that point there was nothing new we could learn.

It is also providing us information that we use to help to help the trial designed assumptions and understanding the PFS and that kind of stuff. So I would say that we've learned what we needed to learn from the phase <unk> in a phase II. That's the reason we went to phase III because we felt at that point there was nothing new we're going to learn.

And.

Chris Howerton: And we just can't take the drug away and stop the study, so we have to keep providing the drug for the patients that are responding. So no, I think we're on firm and solid assumptions for phase three.

And we just can't take drug away and stop the study. So we have to keep providing drug for the patients that are responding. So so no I think I think we are on firm firm and solid assumptions for the phase III.

Very good I will thank you very much for taking the questions. Appreciate it Chris I appreciate it.

Mitchell S. Steiner: They want to ensure we are in a position to build up a unique good relationship. Again, if you would like to ask a question, please press star, then one. To withdraw your questions, press star, then two. The next question comes from Alexandra Heller from Oppenheimer. Please go ahead.

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

The next question comes from Alexandra Heller from Oppenheimer. Please go ahead.

Alexandra Heller: Hi, good morning. Thanks for taking the questions and congrats on the quarter. Can you walk us through how you see 100 fitting into the existing treatment landscape for hormone sensitive prostate cancer and then also your strategic plans for the asset? Thanks.

Hi, good morning, Thanks for taking the questions and congrats on the quarter can you walk us through how you see <unk>.

<unk> fitting into the existing treatment landscape for hormone sensitive prostate resistant cancer and then also your strategic plans for the asset.

Yeah.

Yeah.

Mitchell S. Steiner: So Favira 100, the beauty of this compound is that we were able to sit on the sidelines and watch how the field has evolved over the last 30, 40 years. And what we've learned is that medical castration is, nobody wants surgical castration, and medical castration is the way to go. And interestingly, in this current landscape, with these new drugs that are allowing patients to live longer, such as the antireceptive, targeted agents, and some of the chemotherapy and the PARP inhibitors, you're finding out that patients are living longer.

So severe 100.

The beauty of this compound is is that we were able to the sidelines and watch how that field has evolved over the last 30.40 years and what we've learned is that you know.

Medical castration is nobody want surgical castration castration in medical castration is the way to go and interestingly in this current landscape with these new drugs that are allowing patients to live longer. So that's the answer receptor targeted agents and some of the chemotherapy in the PARP inhibitors, you're finding.

Now that patients are living longer and.

Mitchell S. Steiner: And in all instances, the base is angiolid deprivation therapy. So when we went from 18 months, now you'd be double or triple that, and they're on ADT the whole time. ADT is truly a chronic therapy. And for us to get involved with that, with something that takes advantage of what we've learned. So what did we learn?

All instances the base is Andrew Depravation therapy.

When we went from 18 months now you'd be double or triple that.

And they are on ADT, the whole time, adt's truly a chronic therapy and for us to get involved with that with something that takes advantage of what we've learned so what did we learn we learned that the landscape now is that the agonists such as Lupron Olive garden those kinds of medicines always when you give the injection.

Mitchell S. Steiner: We learned that the landscape now is that the agonists, such as Lupin, Eligard, and those kinds of medicines, always when you give the injection, you have about 14 days, two weeks of high levels of testosterone that then come down, and the castration levels are not, you know, as ideal. And yet, that's what we had, and it worked.

You have about 14 days to weeks of high levels of testosterone then come down and in the castration levels or not.

As ideal.

But yes, that's what we had and it worked and then the antagonist came along and they shut off testosterone right away.

Mitchell S. Steiner: And then the antagonist came along, and they shut off testosterone right away, and the patient gets castrated right away, and it turns out that it also lowers FSA, which is thought to be important for cardiovascular events. I mean, Lupron, if you've had a Lupron type drug, and in my event, they showed this in their study, that if you had a cardiovascular event and you were put on a leukloid, you have a one in five chance of having another one. It's pretty high.

And the patient gets castrated right away and it turns out that it also lowest FSC age, which is thought to be important for cardiovascular events I mean, lupron, if you've had with Lupron type drug and then my event showed this in their study that if you had a cardiovascular event and you would put on.

Luke wide.

I have a one in five chance of having another one it's pretty high so I would argue that if the gnrh antagonist would discovered first that lupron and the agonist probably would never been approved so.

Mitchell S. Steiner: So I would argue that if the GNRH antagonist had been discovered first, Lupin and the agonists probably would never have been approved. So I think this field is definitely moving to GNRH antagonists. Now, in the flavors of GNRH antagonists, now the second challenge is, how do you become part of the medical care standard versus how do you disrupt the medical care standard? So the standard of care right now is a patient comes in every three to four months to get imaging and to see their doctor, and coming in every month doesn't make sense. And we know that because Decorellix was a one-month GNRH antagonist depot, and it did not do well. And it didn't do well because it was not a good drug.

So I think this field is definitely moving to Gnrh antagonists now in the flavors of Gnrh antagonist now the second challenge is how do you how do you.

How do you become part of the medical care standard versus do you how do you disrupt the medical care standard. So the standard of care right. Now is a patient comes in every three to four months to get imaging and to see the doctor and to come in every month does it make sense and we know that because decker, Alex with a one month gnrh.

Antagonist depot, and he did not do well and it didn't do well because it was not a good drug people were kind of using it to castrate day patient by the way then at Lupron. So people were worried about it but the problem is.

Mitchell S. Steiner: People were kind of using it to castrate the patient right away and then with Lupron. So people were worried about it. But the problem is, you know, it didn't fit the standard of care. And so the three-and-four-month depots for Lupin, Eligard, are the standard of care.

It didn't fit standard of care and so the three and four months depots for Lupron in that regard.

The standard of care.

So we had a gnrh antagonist that was a three or four month depot, then you could be easily substitutable.

Mitchell S. Steiner: And so we had a GNRH antagonist that was a three or four month depot; then you could be easily substitutable and become the preferred choice. Because at the end of the day, compliance is really kind of important for this agency. And the reason compliance is important for this agency is because you don't feel well when you get castrated. You lose your libido.

Become the preferred choice because at the end of the day compliance is really kind of important for this agent.

And the reason compliant is important for this agent is because you don't feel well when you get castrated you lose Youll Vito you become.

You.

You develop the <unk>.

Mitchell S. Steiner: You develop a change in body composition with fat and diabetes and loss of muscle mass and, you know, gynecomastia and hot flashes. So, you know, they're constantly looking for a way to get a drug holiday. And so they were in control; the patient was in control of, you know, with their own castration. Then, you know, they may not be as compliant because they want that weekend break or they want to feel good when the kids are there or whatever. And testosterone pops back up.

Change in body composition with fat in diabetes and loss of muscle mass.

Gynaecomasty.

<unk>.

Hot flashes so.

The constantly looking for a way to get a drug holiday and so they were in control that the patient was in control of it.

With their own castration, then they may not be as compliant because they want that we can break where they want to feel good with the kids are there or whatever and testosterone pops back up it's going to cause the tumor to spread and then the patient is going to have to get onto more expensive drugs.

Mitchell S. Steiner: It's going to cause the tumor to spread, and then the patient is going to have to get on to more expensive drugs like, you know, the angioreceptive targeted agents and IV chemo. So we think the strategy for us is that when the patient first develops advanced disease, you know, metastatic prostate cancer that's hormone sensitive, that the foundation, the drug that you start with should be our drug, should be Vera 100.

<unk>.

The Andrew receptor targeted agents.

And IV chemo.

So we think the strategy for us is that when the patient first develops advanced disease.

Metastatic prostate cancer, that's hormone sensitive that.

The foundation that drives that you start with should be our drugs should be <unk> 100, and because it's given every three months.

Mitchell S. Steiner: And because it's given every three months, potentially, if we were given every three months, it would be, it would not buck, standard of care, so doctors will be comfortable providing it, knowing the patient will come back at the same time that they will usually see the patient and the same time they would usually image the patient. So you're not changing the standard of care. And the urologist and the physician get paid because they administer the medicine, and they also get a percentage of the product based on the AWP. So that doesn't change.

Potentially given every three months it would be it would not buck.

Handed a cure so doctors will be comfortable providing it knowing the patient will come back at the same time that we usually see the patient and the same time that we usually image the patient so you're not you're not changing standard of care and the urologists and the physician gets paid because they can administer the medicine and they also get a percentage of the.

The product based on the AWP, so that doesn't change and so our strategy.

Mitchell S. Steiner: And so our strategy and compliance are critical. Now, the other thing that's changed is that the data shows that it's unusual for a patient to get ADT monotherapy today. And so if somebody comes with a hormone-sensitive disease, they can almost certainly have it coupled with some of these other medicines. And that's even another reason why you want to try to decrease, you know, the pill load and other things that the patient is taking and make it simple so that there's one less thing they have to worry about every day.

And compliance is critical now the other thing that has changed also is that the data shows that it's unusual for a patient to get ADT monotherapy today.

And so if somebody comes in with hormone sensitive disease to almost certainly going to have a coupled with some of these other medicines and that's even another reason why you wanted to try to decrease the pill load and other things that the patient is taking.

I'll make it simple that just one less thing they have to worry about every day. So I do think it's going to be very interesting. The other thing and that will be quiet.

Mitchell S. Steiner: So I do think it's going to be very important. The other thing in that, be quiet, is strategically. Strategically, the worldwide market for ADT, Andrew, and deprivation therapy is about $2.6 billion, and that's based on pricing for lupilite. You know, GNRH antagonists are not priced like generic lupilite, and so the market is probably double, if not triple that. And we just don't need to get much of that market to really move the needle.

His strategically strategically the worldwide market for for for.

ADT androgen deprivation therapy is about $2.6 billion.

And that's based on pricing to Leuprolide.

Gnrh antagonists.

Price like a generic leuprolide and so the market is probably double if not triple that and we just don't need to get much of that market to really move the needle. So this is a really attractive option and a real attractive product for us and typically the way. We would think of this product is this is the Cao.

Mitchell S. Steiner: So this is a really attractive option and a really attractive product for us. And basically, the way we would think of this product is this is the kind of product we could have regional partners in Europe, Asia, and maybe hold on to the US ourselves because it's the foundation. That's where you're going to go in and talk to the urologist and medical oncologist about prostate cancer. And as you know, we have subvisibulin for patients that fail ADT, and an angry receptor targeted agent would make a lot of sense. So that's how we're thinking about it out. Perfect, thank you.

The product, we could have regional license our regional partners.

In Europe, Asia, and maybe hold onto the U S ourselves.

Yeah.

It's the foundation.

That's where you're going to go in and call on urologists and medical oncologists about prostate cancer and as you know we have to visa bulent.

For patients that fail ADT and.

And in answering receptor targeted agent would make a lot of sense. So that's how we're thinking about it Alex.

Perfect. Thank you that's super helpful.

Alexandra Heller: Perfect, thank you, that was super helpful. I really appreciate it.

Yes.

Okay.

Okay.

Mitchell S. Steiner: 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.

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.

Mitchell S. Steiner: I appreciate you all joining us on today's call, and I look forward to updating all of you on our progress and our next investor call. Thank you for joining us today.

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

The digital replay of the conference call will be available available beginning approximately noon eastern time today August 12 by dialing one 870.734 475 to nine in the U S and one for one.

Operator: The digital replay of the conference call will be available beginning at approximately noon eastern time today, August 12th, by dialing 1-877-877-8-8-8-1-8-1-8-com. You will be prompted to enter the replay access code, which will be 101-57-539. Please record your name and company when joining. The conference call has now concluded. Thank you for attending today's discussion.

2317008 internationally.

Be prompted to enter the replay access code, which will be 10157539. Please record your name and company when joining the conference call has now concluded. Thank you for attending today's discussion.

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