Q2 2021 Veru Inc Earnings Call

[music].

Good morning, ladies and gentlemen, and welcome to the Vero, Inc. 's Investor Relations Conference call.

Operator: Ladies and gentlemen, and welcome to the Vero Inc.'s Investor Relations Conference Call. All participants will be in the Son-only mode.

All participants will be on listen only mode should you need assistance. Please for the dog conference. The first of all start pressing the starkey of followed by zero.

Operator: Should you need assistance, please signal a conference specialist by pressing the Starkey follow-way zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now turn the conference over to Mr. Sam Fish, Vero, Inc.'s Director of Investor Relations. Thank you.

After this mornings discussion there will be an opportunity to ask questions. Please note. This event is being recorded.

I would now as for the Clos over to Mr. Sam Fisch Ferro inks director of Investor Relations. Please go ahead.

Morning.

The statements made on this conference call may be forward looking statements.

Samuel Fisch: Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business.

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.

Samuel Fisch: Operations, Finances, and Development and Product Portfolio. Thoughts for forward-looking statements are subject to known and unknown risks and uncertainties.

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

Samuel Fisch: and our actual results may differ significantly from those projected, suggested, or included.

Samuel Fisch: in any forward-looking state.

The risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings.

Samuel Fisch: Risks that may cause actual results or developments in different materials

Samuel Fisch: Developments to different materially are contained in our 10Q and 10K SEC filings. I would now like to turn the conference call over to Dr. Mitchell Steiner, Verru-Inch's chairman, CEO, and president. Thank you, Sam, and good morning. With me on this morning's call are Michelle Greco, CFO and CAO, Michael Purvis, EVP, General Counsel and Corporate Strategy, and Sam Fish, Director of Investor Relations. Thank you for joining our call.

I would now like to turn the conference call over to Dr. Mitchell Steiner <unk>, Inc, Chairman CEO and president of <unk>.

Thank you Sam and good morning with me on this morning's call the Michele Greco CFO and C E O micro purpose.

VP General counsel on corporate strategy, and Sam Fisch director of Investor Relations. Thank you for joining our call.

The euro as of late clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers prostate cancer and breast cancer, we continue to invest cash generated from our sexual health commercial business into the clinical development of our potentially.

Mitchell S. Steiner: Vura is a late clinical stage oncology biopharmaceutical company focused on developing novel medicines for the management of two of the most prevalent cancers, prostate cancer and breast cancer. We continue to invest cash generated from our sexual health commercial business into the clinical development of our potentially high-value oncology drug candidates so that our shareholders might realize the maximum value of our oncology biopharmaceutical company. This morning, we will discuss the progress of our late clinical stage prostate cancer and breast cancer drug pipelines, as well as Sabiza Bulin, the new name for Vera 111, a Phase 3 study for the treatment of COVID-19. We'll then provide financial highlights for our second quarter of fiscal year 2021.

High value oncology drug candidates, so that our shareholders might realize the maximum value of our oncology biopharmaceutical company.

Good morning, we will discuss the practice of our late clinical stage prostate cancer and breast cancer drug pipelines as well as.

The <unk> appeal on the new name for tier one of 11 phase III study for the treatment of COVID-19, We will then provide financial highlights for our second quarter of fiscal year of 2021.

<unk> will focus on providing new and novel oral therapies with the unique mechanisms of action and favorable safety profiles.

Mitchell S. Steiner: In oncology, we're focused on providing new and novel oral therapies with unique mechanisms of action and favorable safety profiles for both advanced prostate and breast cancer. Viro anticipates registration clinical trials for up to four oncology indications, and the additional registration phase three clinical trial for spisobulin for COVID-19 makes a total of five potentially registration-enabling clinical trials to commence in calendar year 2021. Prostate Cancer, the company continues to make strong clinical progress advancing subisubulin as a treatment for metastatic castration and androgen receptor targeting agent resistant prostate cancer and Vero 100 for androgen deprivation therapy for metastatic prostate cancer. Subisubulin, which as I mentioned is the new name for Vero 111-11, is an oral first-in-class new chemical entity that targets cross-links and disrupts alpha and beta tubuline subunits of microtubules to disrupt the cytoskelet.

For both advanced prostate and breast cancers Bureau, anticipates, the registration clinical trials for up to for oncology indications and the additional registration phase III clinical trial for <unk> for COVID-19 makes it a total of five potentially registration, enabling clinical trials to commence in calendar year of 2000.

'twenty one.

In prostate cancer. The company continues to make strong clinical progress advancing <unk> as a treatment for metastatic castration and androgen receptor targeting agent resistant prostate cancer and view of 100 for androgen deprivation therapy for metastatic prostate cancer.

To be the Bulin, which as I mentioned is the new named severe one of 11 is an oral first in class new chemical entity the targets cross links and the swaps Alpha and beta tubular on Sep units of microtubules to disrupt decided the skeleton.

And in prostate cancer is also resulted in the disruption of the androgen receptor transport from the cytoplasm into the nucleus.

Mitchell S. Steiner: And in prostate cancer, this also results in the disruption of androgen receptor transport from the cytoplasm into the nucleotor. Subvisibulin is being evaluated in an open-label Phase 1B study in men with metastatic castration and anandrogen receptor targeting agent-resistant prostate cancer. The Phase 1B2 clinical study involved 39 men in the phase 1 portion and 41 men in the phase 2. The phase two portion is completely enrolled and still ongoing. Safety of Sipisubulin appears to be similar to an AR targeting agent like apparatus on anzalutamine based on what has been reported in literature.

<unk> is being evaluated in an open label Phase <unk> study in men with metastatic castration and androgen receptor targeting agent resistant prostate cancer. The phase <unk> clinical study and will 39 men on the phase one portion and 41 men in the phase II portion of the phase II portion is completely enrolled and still.

Ongoing issue.

Safety is two piece of viewing the appears to be similar to an <unk> targeting agent like abiraterone and <unk> based on what has been reported in literature.

Long term daily chronic administration of the drug appears to be feasible and safe we have patients in the phase <unk> portion that have reached two years of treatment without evidence of prostate cancer tumor progression at.

Mitchell S. Steiner: Long-term daily chronic administration of the drug appears feasible and safe. We have patients in the Phase 1B portion that have reached two years of treatment without evidence of prostate cancer tumor progression. At the recommended phase 2, 63 milligram oral daily dose, the most common adverse events were mostly grade 1 and 2 diarrhea, fatigue, and nausea. There have been no reports of neutropenia, significant neurotoxicity, or hair loss.

At the recommended phase 263 milligram oral daily dose the <unk>.

Most common adverse events were mostly grade one and two diarrhea fatigue and nausea.

No reports of neutropenia significant neurotoxicity or hair loss.

The phase <unk> study had also has yielded promising and significant efficacy outcomes.

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. Furthermore, the median radiographic progression-free survival in men who had at least one 63 milligram dose of subvisibulin was 12 months. As there are approximately 10 men still on study, the median progression-free survival in the Phase 2 portion has not been reached.

The efficacy of result show PSA declines of responses as well as objective and durable tumor responses, including partial and complete responses. Furthermore, the median radiographic progression free survival of men, who had at least $1 63 milligram dose of <unk> line was 12 months.

There are approximately 10 minutes still on study the median progression free survival on the phase II portion has not been reached.

We also conducted a PK study to compare the phase <unk> two dosage formulation with the phase III dosage formulation measured blood concentrations of <unk> at the 63 milligram phase one b two dose or similar to the 32 milligram phase III dose which means.

Mitchell S. Steiner: We also conducted a PK study to compare the Phase 1B2 dosage formulation with the Phase 3 dosage formulation. Measured blood concentrations of subesibulin at the 63 milligram Phase 1B2 dose were similar to the 32 milligram Phase 3 dose, which means the Phase 3 dosage formulation has better oral bioavailability.

The phase III dosage formulation has better oral bioavailability.

The scientific abstract reporting the phase one b two safety and efficacy results has been accepted for presentation at the upcoming <unk> scientific meeting, which will be held June for through the eighth.

Mitchell S. Steiner: The scientific abstract reporting the Phase 1B2 safety and efficacy results has been accepted for presentation at the upcoming ASCO-Scientific meeting, which will be held June 4th through the 8th, June 4th to 2021, and it's entitled Subisubulin Vera 111, an oral cyberskeleton disruptor to treat men with metastatic castration-resistant prostate cancer who have failed an angioreceptor-targeted agent to be presented by Mark, Dr. Dr. Mark Markowski, assistant professor for oncology at the Sydney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine and a principal investigator on the study. The company has also reached agreement with the FDA on the phase three clinical trial design for Zibizibulin, and we plan to enroll the first patient in the phase three registration study by the end of this month.

June 4th of the eight to 2021 and it's entitled.

<unk> one of the 11 in the oil side of the skeleton disruptor to treat men with metastatic castration resistant prostate cancer, who have failed an androgen receptor targeted agent to be presented by Mark Dr. Mark of our Koski assistant Professor of oncology at the Sidney Kimmel Comprehensive cancer Center, the Johns Hopkins University School of Medicine.

And the principal investigator on the study.

The company has also reached agreement with the FDA on the phase III clinical trial design.

For <unk> and we plan to enroll the first patient in the phase III registration study by the end of this month.

<unk> III veracity study is an open label randomized study evaluating the efficacy and safety of <unk> 32 milligrams oral daily dosing versus an alternative androgen receptor targeted agent in men with metastatic castration resistant prostate cancer, who have failed at least one antigen.

Mitchell S. Steiner: The Phase 3 Veracity Study is an open-label, randomized study evaluating the efficacy and safety of subisubulin-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-targeting agent but prior to IV chemotherapy. The primary endpoint is median radiographic free survival. The study will be a two-to-one randomization. The trial assumptions expect a medium-ratigraphic progression-free survival of 7.4 months for subvisibulin versus 3.7 months for the alternative and receptor-targeted agent, which, if achieved, would represent a doubling of the improvement in median radiographic progression-free survival with subisubulin compared to the active control. Statistically, using an alpha of 0.05, a power of 98%, and a dropout rate of 30%, the study size will be approximately 245 subjects.

Receptor targeting agent, but prior to IV chemotherapy. The primary endpoint is median radiographic free.

Survival.

The study will be a two to one randomization the trial assumptions expect the medium radiographic progression free survival of seven four months for should be the beulah and versus $3 seven months for the alternative androgen receptor targeted agent, which if achieved will represent a doubling in the improvement in median radiographic progression free.

Viable with the visit Bulin compare to the active control statistically using an absolute zero point of view of five of the power of 98% and the drop out rate of 30%. The study size will be approximately 245 subjects. We expect enrollment to take 10 months recruitment time and 12 months fall.

Mitchell S. Steiner: We expect enrollment to take 10 months for recruitment time and 12 months follow-up after the last patient receives their first dose. The study will be conducted in 45 clinical sites across the United States, and the lead principal investigator will be Dr. Robert Reiser. Deputy Director, University of Virginia Cancer Center, Director of Solid tumor oncology, and Professor of Hematology and Oncology. Subisubulin, if approved, will address a large part of the metastatic prostate cancer market. The use of anandrogen receptor-targeted agents, like Enzoludamide and Apollutamine, has moved earlier in the treatment sequence of advanced prostate cancer.

Low up after the last patient is first dose. The study will be conducted in 45 clinical sites across the United States and the lead principal investigator will be Dr. Robert <unk> the.

Deputy director.

The University of Virginia Cancer Center director of solid tumor oncology and professor of Hematology and oncology.

The ZIP Ulan if approved will address a large part of the metastatic prostate cancer market. The use of an androgen receptor targeted agents like <unk> Napa Ludivine have moved earlier in the treatment sequence of advanced prostate cancer. The two currently approved indications for androgen receptor.

Mitchell S. Steiner: The two currently approved indications for androgen receptor targeting agents are for hormone-sensitive metastatic prostate cancer and for non-metastatic castration-resistant prostate cancer. When patients progress or fail an androgen receptor targeted agent in both of these settings, they now have metastatic castrate-resistant and androgen receptor targeted agent-resistant prostate cancer, the very indication we're pursuing in the Phase 3 clinical trial. This means that as many as 90% of all advanced prostate cancer patients, whose only other option would be to proceed to IV chemotherapy, could potentially benefit from subesibulin.

The targeting agents for hormone sensitive metastatic prostate cancer and for the non metastatic castration resistant prostate cancer from <unk>.

Patients progress of fail and androgen receptor targeted agents in both of the settings.

Now have metastatic castrate resistant.

And androgen receptor targeted agent resistant prostate cancer, the very indication we're pursuing in the phase III clinical trials that this means.

That as many as 90% of all advanced prostate cancer patients who is the only other option would be the proceed to IV chemotherapy could potentially benefit from this comes to beds of viewing by.

By being an orally administered drug with the side effect profile of it appears to be similar to an alternative AOR of targeting agent <unk> could be potentially prescribed by the urologists, they're as important as urologists. Initially play an important role in the management of advanced prostate cancer patients typically the urologist and involves the meta.

Mitchell S. Steiner: By being an orally administered drug with a side effect profile that appears to be similar to an alternative AR-targeting age, Subisubulin could potentially be prescribed by the urologist. This is important, as urologists initially play an important role in the management of advanced prostate cancer patients. Typically, the urologist involves the medical oncologist when the patients require IV chemotherapy.

On colleges and the patients require IV chemotherapy.

Next I will update you on Bureau of 100, and androgen deprivation therapy for the treatment of hormone sensitive metastatic prostate cancer.

Mitchell S. Steiner: Next, I will update you on Vera 100, an antigen deprivation therapy for the treatment of hormone-sensitive metastatic prostate cancer. Androgen deprivation therapy, also known as ADT, is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the disease. Furthermore, ADT 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 Anderson deprivation therapy every three to four months in their office. These injections coincide with follow-up office visits for metastatic or advanced prostate cancer. Furthermore, these injections are administered as a buy-and-bill product and reimbursed under Medicare Part B, not Part D, it's indulged.

Andrew and deprivation therapy also known as ADT is currently the mainstay of advanced prostate cancer treatment and as uses of the foundation of treatment throughout the course of the disease. Furthermore, Adt's continued even even as other endocrine chemotherapy radiation treatments of added of stopped standard medical.

Practice for Urologists and medical oncologists is to administer androgen deprivation therapy every three to four months of new office.

These injections coincide with the follow up the office visits for metastatic of advanced prostate cancer. Furthermore, these injections are administered as a buy and bill product and of reimbursed under Medicare part B not part D as in dog.

So the urologists compensated for both for the drug and administering the drug therefore, urologists prefer injections over oral agent.

Mitchell S. Steiner: So the urologist is compensated both for the drug and for administering the drug. Therefore, urologists prefer injections over oral aid. Gonatropin releasing hormone (GNRH) antagonist treatments are preferred because castration occurs rapidly within a week with no surges of flares and testosterone. Testosterone levels also tend to be lower, which is better for tumor control. GNRH antagonists also lower FSH levels, which is thought to be the reason why there are fewer cardiovascular side effects with GNRH antagonists versus GNRH acin.

Good night of the troponin, releasing hormone gnrh antagonist treatments of preferred because castration occurs rapidly within a week with no surges of players and testosterone.

The SaaS iron levels also tend to be lower which is better for tumor control.

Gnrh antagonist also low fsh levels, which is thought to be the reason why there are fewer cardiovascular side effects with gnrh antagonist vs Gnrh agonists.

There are no gnrh antagonist depot injection formulations commercially approved for treatment beyond one month duration for your 100 is a novel proprietary log acting peptide three month subcutaneous depot formulation of injection designed to address the current limitations of commercially available and Andrew.

Mitchell S. Steiner: There are no GNRH antagonist depot injection formulations commercially approved for treatment beyond one month duration. FIr 100 is a novel proprietary long-acting peptide, three-month subcontinious depotivolation injection designed to address the current limitations of commercially available androgen deprivation therapy. I am happy to report that the GMP manufacturing scale-up is complete, and we plan to start the open-label phase two study in approximately 35 men to evaluate Vero 100 dosing by the end of this month.

Depravation therapy commercially available androgen deprivation therapies.

Happy to report that the GMP manufacturing scale up is complete and we plan to start the open label Phase II study in approximately 35 men to evaluate Bureau of 100 dosing by the end of this month the.

Open label Phase III registration study, whose design has already been agreed upon by the FDA will evaluate the efficacy and safety of Euro of 100, and approximately 100 men with hormone sensitive metastatic prostate cancer and as anticipated the start towards the end of the calendar year of 2021.

Mitchell S. Steiner: The open-label phase three registration study, whose design has already been agreed upon with FDA, will evaluate the efficacy and safety of Vero 100 in approximately 100 men with hormone-sensitive metastatic prostate cancer and is anticipated to start towards the end of the calendar year of 2021.

Next I will just I will discuss the progress of our breast cancer drug pipeline, which includes the <unk> and <unk>.

Mitchell S. Steiner: I will discuss the progress of our breast cancer drug pipeline, which includes anobosome and subvisibuline. 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 receptors, so ER, are the mainstay of breast cancer therapy. According to the 2020 National Comprehensive Cancer Network guidelines, also known as the NCCN guidelines, the recommended first-line treatment in a metastatic setting is either a non-steroidal aromotase inhibitor in combination with the CDK-46 inhibitor or provestrant in combination with the CDK-4-6 inhibitors.

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 deliberation tumor progression and metastasis.

Consequently treatments at the target in blocks of the estrogen receptor. So E. R are the mainstay of breast cancer therapy. According to the 2020 national comprehensive cancer network.

<unk> also known as the NCC and guidelines the recommended first line treatment in the metastatic setting is either a non steroidal aromatase inhibitor in combination with the CDK <unk> inhibitor or for vestment and combination of the CDK for six inhibitors.

The recommended second line treatment in the metastatic setting as for investment in combination of the CD CDK four six inhibitor of CDK for six inhibitor was not used in first line metastatic setting for <unk>.

Mitchell S. Steiner: The recommended second-line treatment in a metastatic setting is Vestrin in combination with a CDK-4-6 inhibitor if a CDK-4-6 inhibitor was not used in first-line metastatic setting. Unfortunately, almost all of the women being treated with these regimens will eventually develop resistance to the estrogen receptor blocking agent and the CDK-4-6 inhibitor.

The <unk> almost all of the women being treated with these regiments will eventually develop resistance to the estrogen receptor blocking agent and the CDK <unk> inhibitor therapies and there are limited clinical data that allow a recommendation for treatment containing in the other CDK for six inhibitor for these patients in the third line metastatic.

Mitchell S. Steiner: And there are limited clinical data that allow a recommendation for treatment containing another CDK-4-6 inhibitor for these patients in a third-line metastatic setting. Alternative treatment approaches that target novel pathways will be required as there are limited treatment options following a CDK-46 inhibitor and an estrogen receptor blocking agent resistance in the management of ER-positive her-2 negative metastatic breast cancer. Interestingly, Like the estrogen receptor, the antigen receptor is found in over 85% of breast cancer. What is the antigen receptors function in breast cancer and breast tissue?

Setting.

Alternative treatment approaches that target novel pathways will be required as there are limited treatment options following the CDK for six inhibitor.

And in estrogen receptor blocking agent resistance in the management of the ER positive her two negative metastatic breast cancer.

Interestingly.

Like the estrogen receptor the androgen receptor is found in over 85% of breast cancers.

What is the androgen receptors function in breast cancer and breast tissue.

Does the stimulate or inhibit breast cancer growth a recent publication in nature medicine.

Mitchell S. Steiner: Does it stimulate or inhibit breast cancer growth? A recent publication in Nature Medicine of an international study headed by Dr. Hickey and her team has provided scientific evidence establishing that the antigen receptor is a tumor suppressor in estrogen receptor positive breast cancer. This means when the angine receptors are stimulated by androgens, it strongly suppresses estrogen receptor-positive breast cancer growth. This explains why, historically, when synthetic antrogens were used to treat breast cancer, they demonstrated good efficacy. But unfortunately, the masculinizing side effects, increases in hematate, and liver toxicity have prohibited their use as a viable treatment.

Of an international study headed by Dr. Hickey and her team has provided scientific evidence establishing that the androgen receptor is a tumor suppressor and estrogen receptor positive breast cancer the.

This means when the androgen receptor is activated by androgen is strongly suppresses estrogen receptor the breast cancer growth. This explains why historically with synthetic androgens, we used to treat breast cancer. They demonstrated good day efficacy, but unfortunately, the masculinizing side effects increases.

In hematocrit, and liver toxicity have prohibited or use as a viable treatment.

Contrast, and Nobu zone, an oral first in class new chemical entity is a selective androgen receptor targeted activating agent and is being developed for the treatment of AR positive ER positive her two negative metastatic breast cancer and would represent the first new endocrine therapy for.

Mitchell S. Steiner: Anobosine, an oral, first in class new chemical entity, is a selective antigen receptor-targeted activating agent and is being developed for the treatment of AR-positive, ER-positive, her2-negative metastatic breast cancer. It would represent the first new endocrine therapy for advanced breast cancer in decades. Novosarm 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.

The advanced breast cancer in decades.

<unk> has extensive non clinical and clinical experience hasn't been evaluated 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.

<unk> is suppressing androgen receptor positive <unk> positive breast cancer cell proliferation and tumor growth in <unk>.

Mitchell S. Steiner: In addition to suppressing angrient receptor positive, ER-positive breast cancer cell proliferation, and tumor growth, Novosarm has other potential beneficial clinical properties. In preclinical studies, Novosarm has demonstrated that it builds and heals cortical and trabecular bone and therefore has the potential to treat osteoporosis and skeletal-related events. NovoSarm has also been shown to build muscle and improve physical function.

<unk> has other potential beneficial clinical properties in preclinical studies <unk> has demonstrated that it builds in heels cortical and trabecular bone and therefore has the potential to treat osteoporosis and skeletal related events in notebooks arm has also been shown to build muscle and to improve physical function.

In clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer patients. Furthermore, because of its tissue selectivity and notebooks arm has a favorable side effect profile with no masculinization thats facial hair acne no increase in nomadic whit in the liver toxicity.

Mitchell S. Steiner: In clinical studies involving elderly subjects and patients with cancer catexia, including breast cancer patients, Furthermore, because of its tissue selectivity, a nois arm has a favorable side effect profile with no masculinization of facial hair or acne, no increase in hematate, and no liver toxicity. The science supporting the efficacy of a novosome by targeting the androgen receptor in ER-positive advanced breast cancer was also the subject of the Nature Medicine Studies published in February 2021 by an independent group of breast cancer experts led by Dr. Hicke.

The science supporting the efficacy of <unk> zone by targeting the androgen receptor in the ER positive advanced breast cancer was also of the subject of the nature of Medicine studies published in February of 2021 by an independent group of breast cancer experts led by Dr. Hickey in their study they showed that by using breast cancer tissue from patients.

Mitchell S. Steiner: In their study, they showed that using breast cancer tissue from patients who had resistance to estrogen receptor blocking agents in CDK-4-6 inhibitor, nobusarm monotherapy exhibited significant antitumor activity, while the combination of anobusarm plus a CDK-4-6 inhibitor demonstrated even greater antitumor activity. They concluded that these data suggest that Nobosarm restores the sensitivity of CDK-K-1. C.D.46 inhibitor-resistant breast cancer tissue to suppression by the CDK-4-6 inhibitor.

Who had resistance to estrogen receptor blocking agents of CDK 46 inhibitor therapies and nobu on monotherapy exhibited significant antitumor activity, while the combination of the nobu start inputs of CDK <unk> inhibitor demonstrated even greater anti tumor activity. They concluded that these data suggest that the.

<unk>, no <unk>, which stores.

Sensitivity of the CDK four six inhibitor resistant breast cancer tissue to suppression by the CDK for six inhibitor.

Two positive phase II studies involving 150 women with ER positive <unk> positive metastatic breast cancer will conduct were conducted.

Mitchell S. Steiner: Two positive phase two studies involving 150 women with AR-positive, ER-positive, metastatic breast cancer were conducted. We will focus on the second of these two studies, the G2-00802 phase two study, which is a two-arm study evaluating 9 milligram and 18 milligram of anobos arm daily dosing in 136 women with AR-positive, ER-positive, her2-negative, advanced breast cancer. Patients in this study were heavily pre-treated, having failed an average of three estrogen receptor blocking agents, and 88% had received prior chemotherapy.

We will focus on the second of these two studies the <unk> 802 Phase III study, which is a two arm study evaluating <unk> nine milligram and 18 milligram of <unk> from daily dosing and the 136 women with ER positive EUR of positive her two negative advanced breast cancer the patients in the study were.

Heavily pretreated, having failed and the average of three estrogen receptor blocking agents and 88% had received prior chemotherapy.

Clinically meaningful tumor responses observed with the Novus arm monotherapy strongly establish the relevance of targeting of the androgen receptor with the selective androgen receptor activating agent women with heavily pretreated estrogen receptor blocking agent resistant ER positive <unk> positive metastatic breast cancer.

Mitchell S. Steiner: Clinically meaningful tumor responses observed with anobosar monotherapy strongly established the relevance of targeting the angrient receptor with the selective antireceptor activating agent in women with heavily pre-treated estrogen receptor blocking agent resistant, AR-positive, ER-positive metastatic breast cancer. The 9 milligram dose was selected for our phase 3 study, as the 9 milligram cohort had similar tumor responses with a slightly better toxicity profile than the 18 milligram dose cohort Focusing on the 9-mogram cohort, and Novosar Monotherapy in the 802 Phase 2 study, had a favorable clinical benefit rate of 32%, and the objective tumor response rate of 29.4%, and nobis aren't appeared safe and well tolerated without virulizing effects, increase in hematate, or liver toxicity. Quality of life measurements demonstrated overall improvement, including mobility, anxiety, depression, and pain.

The nine milligram dose was selected for our phase III study at the nine milligram cohort had similar tumor responses with a slightly better toxicity profile and the 80 milligram dose cohort.

Focusing on the nine milligram cohort and notice on the monotherapy on the 802 phase II study had a favorable clinical benefit rate of 32% and the objective tumor response rate of 29, 4%.

The <unk> appeared safe and well tolerated without realizing effects, increasing them adequate for liver toxicity.

Quality of life measurements demonstrated overall improvement, including mobility and <unk>.

The depression and pain.

We also performed a post hoc subset analysis of the phase II clinical data to understand whether <unk> had any antitumor activity of the efficacy in patients with ER positive ER positive metastatic breast cancer, who are resistant to both an estrogen receptor blocking agents and CDK for six inhibitor. These data.

Mitchell S. Steiner: We also performed a post hoc subset analysis of the Phase 2 clinical data to understand whether Inobosarm had any anti-tumor activity or efficacy in patients with AR-positive, ER-positive metastatic breast cancer who were resistant to both an estrogen-receptive blocking agent and a CDK-4-6 inhibitor. These data were presented at the European Society for Medical Oncology, ESMO, Breast Cancer Virtual Congress in 2021, that was held this past May and actually earlier this month. In the subset analysis, anobosarm treatment in patients with measurable, metastatic, AR-positive, ER-positive breast cancer who had progressed following treatment with an estrogen receptor blocking agent and a CDK-4-6 inhibitor, in this case, palbosiclid, resulted in a clinical benefit rate at 24 weeks of 50% and the best objective tumor response of 30%, including two complete responses and one partial response. The overall mean radiographic regression-pre-survival for the 9-migram group was 10-month.

We presented the European Society for medical oncology ESMO breast cancer Virtual Congress in 2021 that was held this past may actually the earlier this month in.

In the subset analysis, and nobu, sorry of treatment in patients with measurable measurable metastatic ER positive <unk> positive breast cancer, who have progressed following treatment with an estrogen receptor blocking agents and the CDK <unk> inhibitor in this case Pablo sick Lib resulted in a clinical benefit.

The 24 weeks of 50% and the best objected tumor response of 30%, including two complete responses and one partial response, the overall mean radiographic progression free survival for the nine milligram group was 10 months.

Although a small subset one include the <unk> arm has antitumor activity in women with ER positive <unk> positive metastatic breast cancer that is resistant to estrogen receptor blocking agents and CDK <unk> inhibitors. Furthermore, the presence and the degree.

Mitchell S. Steiner: Although a small subset, one can conclude that novosarm has anti-tumor activity in women with AR-positive, ER-positive metastatic breast cancer that is resistant to estrogen-blocking agents and CDK-46 inhibitors. Furthermore, the presence and the degree of antireceptor expression in breast cancer tissues was also important for the Nobis Arm's antitumor activity, which is consistent with Anobosarm being a targeted agent or biomarker that could select or enrich for subjects who are most likely to respond to a Nobosarm therapy.

Of answer of receptor expression in the breast cancer tissue was also important for the <unk> of antitumor activity, which is consistent with the novus arm being a targeted agent.

The marker that could select on rich for subjects, who are most likely to respond to a nobu sorry on therapy <unk>.

<unk> status will be a critical inclusion criteria in the phase III clinical trial design the.

Mitchell S. Steiner: Ayr staining status will be a critical inclusion criteria in the Phase 3 clinical trial design. The subset analyses of AR staining and the Novus Arm antitumor activity from the Phase 2 clinical study will be presented at the upcoming ASCO 2021 meeting on June 4th through the 8th, and the presentations entitled, Advocacy for Novosarm, a selective antireceptive targeted agent, correlates with the degree of AR positiv positive breast cancer in an international phase two study.

The subset analyses of AAR staining in the Novus arm antitumor activity from the phase III clinical study will be presented the the upcoming <unk> 2021 meeting on June four through the eight in the presentation entitled efficacy for Novus arm of selective androgen receptor targeted Asian correlates with the debt.

Agree of AR positivity and advanced ER positive <unk> positive breast cancer, and an international phase III study.

It will be presented by professor of Carload of primary professor of translation of oncology and medical oncologist at the University of Liverpool as opposed to the discussion session.

Mitchell S. Steiner: It will be presented by Professor Carlo Palmeri, Professor of Translational Oncology and Medical Oncologist at the University of Liverpool as a posted discussion session, and the abstract number is 1020. By targeting the angrile receptor in ER-positive metastatic breast cancer, Novosarm introduces a novel endocrine therapy to patients with breast cancer that have exhausted ER blocking agents and CDK-4s inhibitors but prior to IV chemotherapy. In October of 2020, the company met with FDA to discuss the Anobosarm clinical breast cancer program.

The abstract numbers 10 20 of.

The targeting the androgen receptor and ER positive metastatic breast cancer and Novus arm introduces a novel endocrine therapy to patients with breast cancer that have exhausted your blocking agents and CDK for six inhibitors, but prior to IV chemotherapy.

In October of 2020, the company met with FDA to discuss the <unk> of clinical breast cancer program. The FDA agreed to the phase III registration clinical trial. The study designed to evaluate the efficacy and safety of <unk> nine milligrams versus an accident true either ex <unk> for third line.

Mitchell S. Steiner: The FDA agreed to the Phase 3 registration and clinical trial design to evaluate the efficacy and safety of anobosarm 9 milligrams versus an act of control, either XMASD or serum, for third-line treatment of androgen receptor ER-positive her-2 negative metastatic breast cancer patients who have failed a non-steroidal aromotase inhibitor, full vestrian, and the CDK-46 inhibitor. The phase 3 study will be called the R-Test study, and the primary endpoint will be median radiographic progression-free survival.

Treatment of androgen receptor positive her two negative metastatic breast cancer patients for <unk>.

Sales of non steroidal aromatase inhibitor for bass twin and the CDK for six inhibitor phase III study will be called the our test study.

And the primary endpoint will be median radiographic progression free survival.

We're intrigued by the preclinical study results reported in the recent nature medicine publication that I mentioned.

Mitchell S. Steiner: We were intrigued by the preclinical study results reported in the recent Nature Medicine publications I mentioned, and that showed the nobus arm in combination with a CDK-46 inhibitor restored the CDK-4-6 inhibitors' ability to suppress an aggressive receptor-positive, ER-positive, metastatic breast cancer that was previously resistant to both the estrogen receptor blocking agents and CDK-4-6 inhibitors, which, as you know, is the target population in the plan phase three clinical studies We met with the FDA again in April 2021 to discuss the phase three R test clinical study and the best regulatory strategy to address the combination treatment of a novice-armed CDK-4-6 inhibitor in an AR-positive, ER-positive, her-2-negative metastatic breast cancer patient who has progressed following treatment with a CDK-4-6 inhibitor and an ER blocker. First, FDA was enthusiastic about targeting the antin receptor in AR-positive, ER-positive metastatic breast cancer and requested that we also have a companion diagnostic test for this important biomarker to identify the target population.

And in that that showed the nobu arm in combination with the CDK <unk> inhibitor.

We stored the CDK <unk> inhibitors of abilities suppress the androgen receptor positive ER positive metastatic breast cancer that was previously resistant to both of the estrogen receptor blocking agents and CDK <unk> inhibitors, which as you know is the target population of the planned phase III <unk> clinical study.

The met with the FDA again in April of 2021 to discuss the phase III of our tests clinical study and the best regulatory strategy to address the combination treatment of of Novus arm CDK <unk> inhibitor and in a positive ER positive <unk> negative metastatic breast cancer patient who has progressed.

Following treatment of the CDK for six inhibitor and the EUR of blocking agents first FDA was enthusiastic about the targeting the androgen receptor in a positive ER positive metastatic breast cancer and requested we also have a companion diagnostic test for this important biomarker to identify the target pop.

Collation second based on the Fda's regulatory guidance Bureau plans to conduct two separate of Nobu sharp selected our targeted programs program one.

Mitchell S. Steiner: Second, based on the FDA's regulatory guidance, Vera plans to conduct two separate ANOVASARM selective AR-targeted programs. Program 1 is to evaluate Novosarm monotherapy in a third-line metastatic setting. We will conduct a phase three registration clinical study to evaluate the efficacy of a novice arm, Monotherapy, versus the active control, in this case, XMASD-Dain or CERN, and subjects with AR-positive, ER-2-negative metastatic breast cancer who have failed an answer to lay eye, full vestrine, and the CDK-46 inhibitors.

Is to evaluate and nobu saw on monotherapy and the third line metastatic setting.

We will conduct the phase III registration clinical study to evaluate the efficacy of <unk>.

The monotherapy versus the active control on this case exemestane nursery and subjects with ER positive ear of positive her two negative metastatic breast cancer, who have failed on onshore layout for investment.

And the CDK <unk> inhibitors of this is the our tests clinical study and it's an proximately 210 subjects anticipated to commence in June of 2021 per.

Mitchell S. Steiner: So this is the R-Test clinical study, and it's in approximately 210 subjects anticipated to commence in June of 2021. Program 2, new, is to evaluate a novice arm plus a CDK-46 inhibitor combination therapy, moving it earlier in a second-line metastatic setting.

Graham to this new is to evaluate the Novus arm plus a CDK for six inhibitor combination therapy moving it earlier and a second line metastatic setting.

We will we will conduct a phase III clinical trial to evaluate the efficacy and safety of <unk> plus the CDK for six inhibitor of <unk> combination versus an alternative estrogen receptor blocking agent whether it's for question of the AI there'll be active control in.

Mitchell S. Steiner: We will conduct a phase two clinical trial to evaluate the benefits and safety of Novus Arm plus the CDK-46 inhibitor, a bemis-hyclyb combination versus an alternative estrogen receptor blocking agent, whether it's for Vestrian or AI, they'll be an active control, in subjects with AR-positive, ER-positive, hert-2-negative breast cancer who have failed the first line. The first line in this case is Palbo, the CDK-46 inhibitor plus an estrogen-receptive locking mechanism. Clinical study in approximately 106 subjects is expected to commence in calendar Q3, 2021. Now let's focus on phase 3 of our test trial, which is expected to start next month. The design is more specifically as follows.

Subjects with a positive EUR of positive her two negative breast cancer, who have failed the first line and.

In the first line in this case Paolo the CDK for six inhibitor plus an estrogen receptor blocking agent. The clinical study in approximately 106 subjects, who is expected to commence in calendar Q3 2021.

Now, let's focus on the phase III, our test trial, which is expected to start next month. The design is more specifically as follows.

It's an open label multicenter multinational randomized one to one active controlled pivotal study evaluating the efficacy and safety of a nobu sort of nine milligrams daily oral versus an active control, which is going to be either exemestane or CERN there'll be the physician's choice essentially confirmed.

Mitchell S. Steiner: It's an open label, multi-center, multinational, randomized one-to-one, active control pivotal study evaluating the efficacy and safety of Novosarm 9 milligrams daily oral versus an active control, which is going to be either XMS stain or serum. This will be the physician's choice. In centrally confirmed, AR-positive, ER-positive, hurt-2-negative, metastatic breast cancer subjects, have failed a non-stoyal AI, provestrian, and a CDK-416 inhibitor.

A positive ER positive <unk> negative metastatic breast cancer of subjects failed the non steroidal AI for restaurant and of CDK <unk> inhibitor.

Primary endpoint is median radiographic progression free survival. The statistical assumptions are estimated median radiographic free survival of six months for the <unk> monotherapy versus three months of the active control exemestane or Sarah.

Mitchell S. Steiner: The primary endpoint is median radiographic progression-free survival. The statistical assumptions are that the median radiographic-free survival is six months for Anobosar Monotherapy versus three months with the active control, XMestane or CERM. With an alpha of 0.05, 99% power, and a 20% dropout rate, the sample size will be approximately 210 subjects.

With an alpha of zero point of view of 599% power in the 20% drop out rate. The sample size will be approximately 210 subjects. We expect enrollment to take 10 months of recruitment time and 12 months follow up after the last patient is dosed.

Mitchell S. Steiner: We expect enrollment to take 10 months of recruitment time and 12 months of follow-up after the last patient is dosed. We expect that the antine receptor companion diagnostic test will be developed in parallel to the Phase 3 our test study with a large diagnostic company partner. Phase 3, our test study will be conducted at 49 clinical sites across the United States. We are so excited to get going on. Next, I will update you on the Phase 2B clinical study, evaluating Sybizubulin for the treatment of taxane chemotherapy-resistant metastatic triple-negative breast cancer. So metastatic triple negative breast cancer is an aggressive form of breast cancer, and it represents approximately 15% of all breast cancer.

We expect that the androgen receptor companion diagnostic test will be developed in parallel to the phase III. Our test study with a large diagnostic company partners.

The phase III are test study will be conducted in 49 clinical sites across the United States too excited to get going on this next I will update you on the phase two b clinical study evaluating <unk> for the treatment of Taxane chemotherapy resistant metastatic triple negative breast cancer.

So the metastatic triple negative breast cancer is an aggressive form of breast cancer the web.

Presents approximately 15% of all breast cancers. This form of breast cancer does not express the <unk> receptor. The progesterone receptor of her two and as resistance to endocrine therapies. The first line of treatment usually consists of multiple systemic chemotherapies, including the IV taxane chemotherapy. Unfortunately.

Mitchell S. Steiner: This form of breast cancer does not express the estrogen receptor or the progesterone receptor of her two, and is resistant to endocrine therapy. 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, in preclinical studies of human triple negative breast cancer that has become resistant to pachlatoid, which is a taxine. Sabizabulin significantly inhibits cancer proliferation, migration, metastasis, and invasion.

<unk> almost all of these women will eventually develop resistance and exhibit tumor progression and preclinical studies of.

Of human Triple negative breast cancer that has become resistant the paclitaxel, which the taxane <unk> significantly inhibits cancer proliferation migration metastasis and the invasion.

We plan to submit an IND using the safety information from the phase <unk> <unk> on prostate cancer clinical studies planned to initiate an open label three arm phase <unk> clinical study to evaluate the efficacy and safety of <unk>.

Mitchell S. Steiner: Plan to submit an I&D using the safety information from the Phase 1B2, Subisubulin Prostate Cancer Clinical Studies, plan to initiate an open label, three-armed Phase 2B clinical study to evaluate the efficacy and safety of subisibulin, Subvisubulin plus Trilvy combination versus Trudelvie alone in the treatment of approximately 150 metastatic triple negative breast cancer patients that have failed at least two systemic chemotherapie In human prostate cancer clinical trials, we've already shown that chronic oral daily administration of subesibulin was well tolerated with no reports of nutropenia.

The beauty of Bulent pledged for Adobe combination versus true Dalbey alone in the treatment of approximately of 150 metastatic triple negative breast cancer patients that have failed at least two systemic chemotherapies, including IV taxane.

And human prostate cancer clinical trials, we've already shown chronic oral daily administration of <unk> was well tolerated with no reports of neutropenia.

It will be interesting to see where the CBC bulin in combination, which day it'll be results in less neutropenia with a better efficacy.

Mitchell S. Steiner: It will be interesting to see whether bisobulin in combination with Trudelevy results in less neutropenia, with better efficacy, similar to what has been observed in a metastatic non-small cell lung cancer trial with plentibulins, an Ivy Coutachein. Diet targeted antitubulin with a similar mechanism to subisubulin, in combination with dositaxil, which is a taxine, prevent dositaxil-induced neutropenia.

Similar to what has been observed in a metastatic non small cell lung cancer trial were plenty of viewing.

And Ivy Colchicine.

Sky targeted anti 2 billion with the similar mechanism to submit the bulent.

In combination with Docetaxel, which is a taxane prevented docetaxel induced neutropenia.

Phase <unk> study is planned to commence in the calendar Q3, 2021, and as I mentioned the successful this would represent a second major clinical oncology indication for <unk>.

Mitchell S. Steiner: The phase 2B study is planned to commence in the calendar Q3 2021, and as I mentioned, if successful, this would represent a second major clinical oncology indication for subvisibul. This week, we are now moving to the COVID-19 study. This week, we expect to enroll our first patient in the Phase 3 COVID-19 study, evaluating subisubulin for the treatment of hospitalized patients with COVID-19 who are at high-risk for acute respiratory distress syndrome. Subbesibulin in this setting is a novel once daily oral 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 infections and the subsequent debilitating inflammatory effects that lead to ARDS and death.

This week now moving to the COVID-19 study. This week, we expect to enroll our first patient in the phase III COVID-19 study evaluating <unk> for the treatment of hospitalized patients with COVID-19, who was high risk of the acute respiratory distress syndrome.

It's the best appealing 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 <unk>.

And debt.

We conducted the double blind randomized placebo controlled phase II clinical trial evaluating once daily oral dosing of <unk> on 18 milligrams versus placebo and 39 hospitalized COVID-19 patients who had high risk for the acute respiratory distress syndrome.

Mitchell S. Steiner: We conducted a double-blind, randomized placebo-controlled phase two clinical trial evaluating once-daily oral subisubulin 18 milligrams versus placebo and 39 hospitalized COVID-19 patients who had high risk for acute respiratory distress syndrome. The primary advocacy endpoint was a proportion of patients alive without respiratory failure at day 29. For the primary endpoint in hospitalized patients and the modified intent-to-treat population, subisibulin treatment compared to placebo had a clinically meaningful reduction in the proportion of patients who were treatment failures dead or alive with respiratory failure, with a 30% treatment failure rate in the placebo group and equals 20, compared to 5.6% in the subisubulin-treated group n = 18 at day 29.

The main efficacy endpoint, which proportion of patients alive without respiratory failure of day 29 for the primary endpoint in hospitalized patients of modified intent to treat population to visit view on treatment compared to placebo had a clinically meaningful reduction in proportion of patients who are treatment failures, Devin will arrive with respiratory failure.

With the 30% treatment failure rate in the placebo group and equals 20 compared to five 6% in the <unk> treated group and equals 18 of day 29. This represents an 81% relative reduction in the <unk> treated failures.

Mitchell S. Steiner: This represents an 81% relative reduction in its Ibizubulin treated failure rate. As a secondary endpoint in the intent-to-treat population, subisibulin reduced the proportion of patients who died during the study from 30% in the placebo group to 5.3% in the subisubulin treated group in the subisubulin treated group. In an M-I-T-T population, subizubulin showed a statistically significant and clinically meaningful reduction in days in the ICU, with subisubulin patients at three days versus placebo at 9.55 days, p-value 0.04. Additionally, subizubulin reduced the days of mechanical ventilation for 5.4 days in the placebo group to 1.6 days in the subizubulin treated group.

For the secondary endpoint in the intent to treat population for.

<unk> reduced the proportion of patients who died on study from 30% in the placebo group to five 3% in the <unk> treated group of the P value of 0.0 for for this is an 82% relative reduction in mortality in the <unk> treated group and the N and M ITT population.

Asian, <unk> and show the statistically significant and clinically meaningful reduction days in the ICU Mitsubishi Bulent patients of three days versus placebo at 955 days P values. Your point of view of for <unk> and reduce the days of mechanical ventilation for five four days in the placebo group to one six days.

In the <unk> treated group and <unk> was tolerated with the good safety profile of <unk>.

Mitchell S. Steiner: And subisibulin was tolerated with a good safety profile. The company was granted an expedited end of phase two meeting with FDA to discuss the next steps, including the phase three clinical registration trial design for subisibulin COVID-19, other. The FDA agreed to use Subisubulin for the COVID-19 Phase 3 trial as a double-blind, multi-center, multinational, randomized 2-1 placebo-controlled trial evaluating daily oral doses of 9 milligrams of subizubulin for up to 21 days versus placebo and 300 hospitalized COVID-19 patients who are at high risk for ARDS.

<unk> was granted an expedited end of phase two meeting with FDA to discuss the next steps, including the phase III clinical registration trial design for Sip distributing COVID-19 program the.

The FDA agreed.

Upon the <unk> for the COVID-19 phase III trial as a double blind.

Multicenter multinational randomized two to one placebo controlled trial evaluating daily oral doses of nine milligrams of <unk> for up to 21 days versus placebo on 300 hospitalized COVID-19 patients.

Who had high risk for <unk> to be 200 subjects will be treated with the busy bulin in 100 subjects will receive placebo.

Mitchell S. Steiner: There will be 200 subjects that will be treated with subizubulin, and 100 subjects will receive placebo. Because of better oral bioavailability, Stemic blood levels from the 9 milligrams of bisobulin dosage are similar to the 18 milligrams of bisobuline formulation used in the phase two study.

Because of better oral bioavailability.

Systemic blood levels from the nine milligrams of <unk> dosage is similar to the 18 milligram of <unk> formulation used in the phase II study of <unk>.

Subjects in both of the two visit Bulent placebo arms will also be allowed to receive standard of care the.

Mitchell S. Steiner: The subjects in both the subvisibule and placebo arms will also be allowed to receive standard of care. The primary efficacy endpoint will be the proportion of patients that die during the study up to day 80. So it's mortality.

Primary efficacy endpoint will be proportion of patients the die on study up to day 80.

So it's the mortality secondary endpoints will include the proportion of patients without respiratory failure days in the ICU W. H O ordinal scale for clinical improvement changed from baseline days on mechanical ventilation days in the hospital and viral load the <unk>.

Mitchell S. Steiner: Secondary endpoints will include the proportion of patients without respiratory failure, days in the ICU, the WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. The study will be conducted in the United States, Brazil, Argentina, Mexico, and Colombia. Enrollment is targeted to be completed by year-end, and the company has sufficient clinical drug supply on hand to complete Phase 3 clinical studies. We will seek funding from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Resources, Barta, and other agencies to try to fund the estimated amount of the commercial drug to supply the needs of the U.S. population, assuming confirmatory positive clinical results and FDA approval. COVID-19 infection rates and hospitalizations are still at a serious level. There are mutating and double-mutating virus strains, and large parts of the population are either unwilling or unable to get access to effective vaccines.

<unk> will be conducted in the United States, Brazil, Argentina, Mexico, and Colombia, and enrollment is targeted to be completed by year end. The company has sufficient clinical drug supply on hand to complete the phase III clinical study we.

We will seek funding from the biomedical advanced research and development authority of the U S Department of health and human resources BARDA and the other agencies. The trying to fund the estimated amount of the commercial drug to supply the needs of the U S population, assuming confirmatory positive clinical results and FDA approval.

COVID-19 infection rates hospitalizations are still at a serious level.

There are of mutating and double mutating virus strains in large parts of the population either unwilling.

We're unable to get access to effective vaccines in fact glue.

Global cases of COVID-19 are at the highest level since the start of the pandemic.

Mitchell S. Steiner: Global cases of COVID-19 are at the highest level since the start of the pandemic, and it is clear that effective and safe oral therapeutics that can prevent deaths and hospitalized patients with moderate severe COVID-19 disease who are at risk for acute respiratory distress syndrome are desperately needed. We strongly believe that Subisibulin, 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 and promising clinical results, the company continues to be duty-bound during this persistent global pandemic to pursue the COVID-19 indication, even though it's not our primary focus of the company. We believe we have the resources to conduct our planned subisubulin for COVID-19 phase three trial without impacting the other cancer drugs in clinical development. Finally, I'll comment on TATFIN.

It is clear the.

Effective and safe oral therapeutic that can prevent deaths in hospitalized patients with moderate to severe COVID-19 disease, who had risks for <unk>.

The respiratory distress syndrome is desperately needed we strongly believe that the visit bulin with its anti inflammatory and anti viral properties and its favorable safety profile can be greatly can beat 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 the COVID-19 indication, even though it's not our primary focus of the company.

We believe we have the resources to conduct a planned <unk> for COVID-19 phase III trial without impacting the other cancer drugs in clinical development.

Finally, I'll comment on tests in Tampa is our combination of Dallas low five milligram finasteride five milligram urology product developed the treat low urinary tract symptoms caused by benign prostatic hyperplasia also known as BPH. The combination product contains tadalafil, which is approved for the treatment of BPH and erectile.

Mitchell S. Steiner: TANFIN is our combination of Dentalpho 5 milligram fanasteri and 5 milligram urology product, developed to treat lower urinary tract symptoms caused by benign prosthetic hyperplasia, also known as BP8. The combination product contains todalaphil, which is approved for the treatment of BPAH and erectile dysfunction, and fanasteri for BPA. We submitted the NDA for Tadfin to FDA in February, and FDA accepted the NDA in April. Our Purdue date decision for Tad Finn will be December of 2021.

Dysfunction and for.

Finasteride for BPH, we submitted the NDA for Tad fan to FTA in February.

<unk> accepted the NDA in April.

<unk> day decision.

Yes.

The decision date for <unk>.

<unk> will be December of 2021, we plan to launch Tad fan if approved via third party of telemedicine channels and with the launch issues should provide near term source of additional revenues for for Bureau, So we're not gonna have of marketing and selling group, who will be done through telemedicine.

Mitchell S. Steiner: We plan to launch TadFIN if approved through third-party telemedicine channels, and when it is launched, it should provide a near-term source of additional revenues for VIRU. So we're not going to have a marketing and selling group. It will be done through telemedicine. I will now turn the call over to Michelle Greco, CFO, and CAO to discuss the financial highlights. Michelle?

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

Thank you that the Stena is Dr. Steiner indicated we're having a great year.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we're having a great year. In December, the company sold Pre-boost for $20 million, and in February, the company completed an equity raise, which resulted in $107.9 million in net proceeds after deducting underwriting commissions and costs. And to give you a sense of the continuation of our revenue growth trajectory, in the U.S. prescription channel, we sold 171,900 units the year-to-date in fiscal 2020, compared to 24,200 units the year-to Let's start our highlights with the second quarter results for the three-month end on March 31st, 2021.

For the company for $20 million and in February the company completed an equity raise which resulted in a $107 $9 million of net proceeds after deducting underwriting commissions and costs.

And the give me a sense of the continuation of our revenue growth trajectory on the U S. Prescription channel we sell the 171900 units year to date in fiscal 2020 compared to children of 47200 units year to date in fiscal 2021 on increase of 44%.

Let's start on highlights for the second quarter results for the three months ended March 31 2021.

The net revenues were up 34% to $13 $3 million for line $9 million on the part of your second quarter.

Michele Greco: Overall, net revenues were up 34% to $13.3 million from $9.9 million in the prior year's second quarter. The company reported record quarterly sales for its U.S. prescription business of $10.3 million, an increase of 48% from $7 million in the prior year's second quarter. Overall, gross profit was $10.9 million or 82% of net revenues compared to $7.4 million or 75% of net revenues in the prior year quarter. The increase in gross profit and gross margin was driven primarily by increased sales in the USF2 prescription business.

The company reported record quarterly sales for the prescription business of $10 3 million, an increase of 48% from $7 million from the prior year second quarter.

Overall gross profit was $10 9 million or 82% of net revenue compared to seven $4 million for 75% of net revenues from the prior year quarter.

The increase in gross profit and gross margin is driven primarily by the increase sales in the U S ex situ prescription business.

Operating expenses for the quarter increased to $12 $4 million compared to the prior year quarter of $7 $7 million range.

Michele Greco: Operating expenses for the quarter increased to $12.4 million compared to the prior year quarter of $7.7 million. Research and development costs were $7.6 million compared to $3.9 million in the prior year quarter. The operating loss for the quarter was $1.5 million compared to $300,000 in the prior year's second quarter. Non-operating expenses were $1.4 million compared to $644,000 in the prior year's second quarter and primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.

Search and development costs were $7 $6 million compared to $3 $9 million from the time of year quarter.

The operating loss for the quarter was $1 $5 million compared to $300000 from the prior year quarter.

Non operating expenses were $1 4 million compared to $644000 from the prior year second quarter, and primarily consisted of interest expense and the change on 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 Rerecorded of tax expense of $22000 compared to the tax benefit of $133000 from the prior year second quarter.

Michele Greco: For the quarter, we recorded a tax expense of $22,000 compared to a tax benefit of $133,000 in the prior year's second quarter. The bottom line result for the second quarter of fiscal 2021 was a net loss of $2.8 million or $4.0.4% per diluted common share compared to a net loss of $811,000 or $1.1 per diluted common share in the prior year's second quarter. Now turning the highlights for the results for the 6 months ending on March 31st, 2021.

The bottom line bottom line results for the second quarter of fiscal 2021, with the net loss of $2 $8 million of <unk> <unk> per diluted common share compared to the net loss of $811000 or one cent per diluted common share on the prior year second quarter.

Now turning the highlights for the results for the six months ended March 31st 2021.

For the first six months of fiscal 'twenty. One total net revenues were up 36% to $28 million from $25 million from the prior year period.

Michele Greco: So for the first six months of fiscal 21, total net revenues were up 36% to $28 million from $20.5 million in the prior year period, a record high for the six-month period ended March 31st. The company reported growth in FC2 sales in the U.S. prescription business and in the global public sector business. Net revenue from the U.S. prescription business was up 49% to $19.4 million from $13 million in the prior year period. The global public sector business was up 11% to $7.7 million.

Record high for the six months period ended March 31.

Company reported.

Growth in the FC two sales in the U S prescription business and on the global public sector business net revenue from the U S. Prescription business was up 49% to $19 $4 million from $13 million from the prior year period, the global public sector business was up 11% for $7 $7 million.

Overall gross profit was $21 $7 million or 78% of net revenue compared to $14 $7 million for 72% of net revenues in the prior year period.

Michele Greco: Overall, gross profit was $21.7 million or 78% of net revenues compared to $14.7 million or 72% of net revenues in the prior year period. The increase in profit and gross margin is due primarily to an increase in the U.S. prescription business. Operating expenses increased by $5.6 million to $22.4 million compared to the prior year period of $16.8 million. The increase is primarily driven by research and development costs, which increased by $4 million to $13.3 million from $9.2 million in the prior year period.

The increase on profit and gross margin is due primarily the royalty from the U S prescription business.

Operating expenses increased by $5 6 million to $22 $4 million compared to the prior year period of $16 $8 million.

The increase is primarily driven by research and development costs, which increased by $4 million $13 3 million from $9 $2 million from the prior year period.

Income for the period was $17 $7 million compared to an operating loss of $2 $1 million from the prior year period.

Michele Greco: Operating income for the period was $17.7 million compared to an operating loss of $2.1 million in the prior year period, an increase of $19.8 million. The increase is primarily due to a gain on the sale pre-boost of $18.4 million. Excluding this gain, we had an operating loss of $694,000 for the period. Non-operating expenses were $3.2 million compared to $2.2 million in the prior period and primarily consisted of interest expense and the change in the fair values of derivative liabilities related to the synthetic royalty finance. For the six-month period, we recorded a tax expense of $100,000 compared to a tax benefit of $210,000 in the prior year period.

The increase of $19 8 million the increase was primarily due the current on the sale of pre burst of $18 $4 million. Excluding this gain we had operating losses of $694000 for the period.

Non operating expenses were $3 2 million compared to $10 2 million in the Pea.

Prior year period on primarily consisted of interest expense and the change on the fair values of the derivative liabilities related to the synthetic royalty financing for.

For the six month period, we recorded the tax expense of $100000 compared to the tax benefit of $210000 from the prior year period.

The company has net operating loss carryforwards for the U S federal tax purposes of $41 $7 million with $13 $5 million expiring in the.

Michele Greco: The company has net operating loss carry forwards for U.S. federal tax purposes of $41.7 million, with $13.5 million expiring in years through 2038, and $28.2 million, which is carried forward indefinitely. Our UK subsidiary has net operating loss carry forwards for reports of $61.3 million, which do not expire. The bottom line results for the first six months of fiscal 2021 were net income of $14.4 million or $0.18 per diluted common share compared to a net loss of $4.1 million or $6 per diluted common share in the prior period. Excluding the gain on sale of pre-boost, the adjusted net loss was $4 million or $6 per diluted common share in the current period. Turning to our balance,

Yes through 2038 on $22 million, which the carryforward indefinitely.

The U K subsidiary has net operating loss carryforwards of $61 $3 million, which do not expire.

Bottom line results for the first six months of fiscal 2021, with net income of $14 $4 million or <unk> 18 per diluted common share from.

The net loss of $4 $1 million for six cents per diluted common share from the prior period.

Excluding the gain on sale of printers. The adjusted net loss was $4 million for six cents per diluted common share on the time period.

Turning to our balance sheet as of March 31, 2021, our cash balance of $136 $7 million on.

Michele Greco: As of March 31st, 2021, our cash balance was $136.7 million, and our accounts receivable were $5.1 million. Due to our sales pre-boost, we added $15 million in cash during December and $5 million in notes receivable, which will be collected over the next 15 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. Net proceeds were $107.9 million. Our networking capital was $137.2 million at March 31st, 2021 2021, compared to $12.3 million at September 30, 2020.

The accounts receivable of $5 1 million, giving a lot of sales pre booths, we added $15 million on cash during December and $5 million of notes receivable, which will be collected over the next 15 months.

On February we completed an underwritten public offering of $7 million 419350 for shares of our common stock at a public offering price of $15 57 per share net.

Net proceeds of $107 $9 million of net working capital was $137 2 million at March 31, 2021, compared to $12 3 million at September 30 of 2020.

During the six months ended March 31, 2021, we used cash of $1 9 million for operating activities compared with $4 $9 million in scrapping activity from the prior period.

Overall, we're delighted to see the continued increases on sales in the U S prescription business and look forward to increasing sales on the global public sector business in the third quarter. These revenue sources together with our strong balance sheet continue to be a source of funds we used to invest in our.

Michele Greco: During the six months ended March 31st, 2021, we used cash of $1.9 million for operating activities compared with $4.9 million used for operating activities in the prior period. Overall, we're delighted to see continued increases in sales in the U.S. prescription business and look forward to increasing sales in the global public sector business in the third quarter. These revenue sources, together with our strong balance, should continue to be a source of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into an oncology pharmaceutical company with the focus on developing novel medicines for the management of prostate and breast cancer. Now I'd like to turn the call back to Dr. Steiner. Thank you.

Promising pharmaceutical clinical development programs as we continue to transform our company into an oncology biopharmaceutical company with the focus on developing novel medicines for the management of prostate and breast cancers.

I'd like to turn the call back to Dr. Steiner.

Thank you Michelle our company's fundamentals of strong we've enjoyed another strong financial quarter with the record U S. FCT prescription net revenues, which has allowed us to significantly advance our clinical programs based on year to day performance, we expect to have of Rick a record year in revenue with the robust performance of the sexual health business.

On this plus the prospects for additional future revenue from Tat fine cut.

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 product candidates as well as with the <unk> COVID-19 phase III clinical study with.

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

We plan to continue to generate robust growing revenues for the sexual health business as previously announced the company also continues to explore strategic alternatives regarding its legacy female health company business, which markets of the <unk> female condom internal condom, including continuing to operate the business.

Mitchell S. Steiner: With the robust performance of the sexual health business, plus the prospects for additional future revenue from TATFIN, coupled with our strong cash position, we believe that we'll be able to substantially invest in the continuous clinical development of our prostate and breast cancer drug product candidates, as well as with Subisubulin COVID-19, phase three clinical study, and plan to continue to generate robust growing revenues for the sexual health business. As previously announced, the company also continues to explore strategic alternatives regarding its legacy female health company business, which markets the FC2 female condom internal condoms, including continuing to operate the business.

It's been a very very busy quarter as we have successfully transplant continuing to transform our company into a late clinical stage oncology biopharmaceutical company supported by growing revenue from our cash generating sexual health business, we plan to and will potentially up to five registration studies and two <unk>.

As two studies of this calendar year more specifically.

Mitchell S. Steiner: It's been a very, very busy quarter as we have successfully continued to transform our company into a late clinical stage oncology and biopharmaceutical company supported by growing revenue from our cash-generating sexual health business. Plant and Roe potentially will conduct up to five registration studies and two phase two studies this calendar year. More specifically,

The prostate cancer <unk> in an open label Phase III of Rhapsody study in men with metastatic castration and androgen receptor targeted agent resistant prostate cancer grew 100, and an open label Phase II and later in the year and open label Phase III for hormone sensitive metastatic prostate cancer.

For breast cancer and <unk> in an open label Phase III, our test study and a positive EUR positive her two metastatic breast cancer in a third line metastatic setting after failing of non store layout for restaurant and of CDK <unk> inhibitor and notebooks are on plus <unk> combination.

Mitchell S. Steiner: Prostate cancer, Subvisbulin in an open label phase 3, veracity study in men with metastatic castration and angren receptor targeted adhesion resistant prostate cancer. Vera 100, in an open label phase 2, and later in the year, an open label phase 3 for hormone-sensitive metastatic prostate cancer. For breast cancer, Anobosarmin, an open-label phase 3, our test study, an AR-positive, ER-positive her 2 metastatic breast cancer, in a third-line metastatic setting after failing a non-storely eye, phovestrian, and a CDK-4-6 inhibitor, and Novosarm plus Femm cyclib combination in an open label phase two study in AR positive, ER positive, her two negative metastatic breast cancer in a second line metastatic setting after failing palbo cycloid plus an ER blocking age.

And in the open label Phase II study and a positive ear of positive her two negative breast cancer metastatic breast cancer in a second line metastatic setting after failing <unk> plus an ear of blocking agent.

To visit Bulin, so busy bulent plus drilled the Lv combination, which would tell of the alone and an open label Phase <unk> study in metastatic triple negative breast cancer patients who have failed at least two systemic chemotherapies, including an IV taxane.

For COVID-19.

The <unk> nine milligrams in the phase III trial double blind multicenter multinational randomized placebo controlled trial.

The hospitalized COVID-19 patients who are at high risk.

And if we do confirm the promising results that we observed in the completed phase II clinical study, we expect to seek an emergency use authorization for this indication.

Mitchell S. Steiner: Subvisubulin, Subvisubulin plus Tril-Delvey combination, or Tridelvie alone, in an open-label-phase 2B study in metastatic triple-negative breast cancer patients that have failed at least two systemic chemotherapies, including an IV tax, for COVID-19. Tabizibulin 9 milligrams in a phase 3 trial, double-blind, multi-centered, multinational, And if we do confirm the promising results that we observed in the completed phase two clinical study, we expect to seek an emergency use authorization for this indication. With that, I will now open the call to questions.

With that I will now open the call for questions operator.

Thank you ladies and gentlemen at this time on when we begin the question and answer session.

To answer the question you May Press Star then one on your telephone keypad.

If you're already James Speaker phone.

So you please pickup your handset before question of the keys to ensure the best on quality.

Part of the 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 set of stars on wanted to rejoin the question queue, we will pause momentarily to assemble the roster.

Operator: Yes, thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press any number 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.

Yes.

And the first question comes from Chris Howerton with Jefferies.

Excellent congratulations on the very broad progress here to you mentioned the team. So thanks for taking the questions as well.

For the I guess for the two questions from me first up with true with respect to excuse me two <unk>.

Operator: To withdraw the question, please press a star other than 2. Please limit yourself to one question and one follow-up. If you have further questions, you may reenter the question Q. Once again, that is star than one to rejoin the question Q. We will pause momentarily to assemble the roster. And the first question comes from Chris Howardton with Jeffries.

I guess could you give us just a little more color in terms of what the impetus was two <unk>.

We formulate the drug and it sounds like a more bioavailability.

On dosage form and then what additional kind of operational where it may be required to.

Chris Howardton: Excellent. Congratulations on the very broad progress here, Mitch, and the team. So, for the, I guess, for the two questions from me, first up, with respect to Subbizabulin, I guess, could you give us just a little more color in terms of what the impetus was to reformulate the drug, and it sounds like a more

Of that formulation of fully ready to go for the upcoming clinical trials and of course commercialization.

On the second question that I have is related to.

Our expression levels and the potential for a companion diagnostic.

So I guess for that feature of the <unk> development program.

Chris Howardton: more bioavailability dosage form, and then, you know, what additional kind of operational work may be required to have that formulation fully ready to go for

Is the expectation that there will be some cutoff of expression and.

Chris Howardton: for the upcoming clinical trials and, of course, commercialization. The second question that I have is related to AR expression levels and the potential for a companion diagnostic.

If so or if not I guess will we learn we learned at the <unk> presentation with respect to that thanks.

Great. So the first question is on the reformulation as you know and in drug development, you typically start with the cheapest way to to do the study and that is you take the drug and you put it the packet into a capsule and Thats, what you get patients in the phase <unk> <unk> two and so so what we've done is we the to be marketed for them.

Chris Howardton: So I guess the feature of the Anobosarm development program is the expectation that there will be some cutoff.

Chris Howardton: Some cutoff of the AR expression and if so or if not, I guess we will learn at the ASCO presentation with respect to that thing. Great.

Mitchell S. Steiner: So the first question is about reformulation. As you know, in drug development, you typically start with the cheapest way to do the study, and that is, you take the drug and pack it into a capsule, and that's what you give patients in phase 1B2. And so what we've done is the 2B marketed form, so I've got to be careful because the lawyers get mad when I say that. But the 2B marketed form doesn't mean that we got approved. It means that it's the form that we would use if approved.

So I've got to be careful because of the words get mad when I say that with the to be marketed form doesn't mean that we got approved it means that it's the forum that we would use if approved and typically in your phase III you have to use the forum that is to be marketed so that you have your commercial for them. So the answer your question. There is no further.

Work.

Serendipitously when they put in the excipient and created the.

The formulation for the phase III and we did the PK study and the phase <unk> to it.

Mitchell S. Steiner: And typically, in phase three, you have to use the form that is to be marketed so that you have your commercial form. So the answer to your question, there's no further work. serendipitously, when they put in the excipients and created the formulation for phase three, and we did the PK study in phase 1B2, it turns out that the excipients allowed for better oral bioavailability. And so that means that the 32 milligram dose is equivalent to the 63 milligram dose. And it raised the question that in phase 1B2, where did the other 31 milligrams go? The answer is that the other 31 milligrams didn't disappear. It's staged in the gut.

It turns out that the excipient allowed for better oral bioavailability and so that means that the 32 milligram dose is equivalent to the 63 milligram dose and have raised the question that in the phase <unk> <unk> two.

Where is the other 30 31 milligrams go.

The answer is the out of the 31 milligrams didnt disappear at stages in the gut and it may be responsible for maybe for some of the diarrhea that we're seeing for example, even though its grade one grade two.

So on potential benefit of the re formulation is that we may in the phase III setting see some fewer side effects that would may be related to residual drug that was not absorbed. So so so we don't have any additional work we have the to be marketed for them and thats for them is the one that we're going to be using non.

Mitchell S. Steiner: And it may be responsible for some of the diarrhea that we're seeing, for example, even though it's grade one or grade two. So one potential benefit of the reformulation is that we may, in the phase three setting, see some fewer side effects that may be related to residual drug that was not absorbed. So we don't have to do any additional work. We have the marketed form, and that form is the one that we're going to be using not only in phase three for prostate cancer.

The only in the phase III for prostate and we're using it in the nine milligram version in the phase III for COVID-19, which will start this week and we're using it also in the triple negative breast cancer study that.

So bit of viewing going against.

Two of the Lv and in combination with Trudeau. The second question has to do with the <unk> expression.

Mitchell S. Steiner: We're using it in the 9 milligram version in the phase 3 for COVID-19, which will start this week, and we're using it also in the triple negative breast cancer study that has subvisibuling going against Trudevary and in combination with Trudelvie. The second question has to do with AR expression.

This is exciting because you know every so often you'll find somebody says they have of biomarker or a targeted Margaret this is truly a targeted marker.

And what we're going to be presenting in the June <unk> meeting is on.

Or are the day to the support that.

And.

Mitchell S. Steiner: This is exciting because, you know, every so often you'll find somebody says they have a biomarker or a targeted marker. This is truly a targeted marker. And what we're going to be presenting at the June ASCO meeting are the data that support that. And as you would imagine, there is some expression level where you get better activity. Because for something to be considered a targeted marker, it has to be, for activity to happen, it has to happen through that marker.

And as you would imagine there is some expression level, where you get better activity because for something to be considered a targeted Margaret has for the activity that happened in the has to happen to that Margaret So on this case.

Wouldn't expect activity with the Novus arm if the antigen receptor is not present in the second thing is the more of that marker. That's the that's being expressed the better the results should be at least from an antitumor activity and we see all of that until we're going to be.

Mitchell S. Steiner: So in this case, you wouldn't expect activity with a novice arm if the angriceptor is not present. And the second thing is, the more of that marker that's being expressed, the better the result should be, at least from an antitumor activity. And we see all that.

Presenting in the <unk> paper at the <unk> presentation is the data to support that.

And.

Particularly as it relates to.

Objective tumor responses target tumor responses clinical benefit range.

Mitchell S. Steiner: And so we're going to be presenting in the ASCO paper, an ASCO presentation, the data to support that, and particularly as it relates to objective tumor responses, target tumor responses, clinical benefit rates, and radiographic progression-free survival.

The to grab the progression free survival of all goes to the right. It all goes as expected as you would expect of Ah is truly the reason why <unk> of its working.

And so because of that it becomes critical.

Have a companion diagnostic.

Mitchell S. Steiner: It all goes as you would expect if AR is truly the reason why a nobus arm is working. And so because of that, it becomes critical that you have a companion diagnostic that can be done, and, you know, it's immune histochemistry, so it's not complicated, which is a good thing for us because we don't want a complicated companion diagnostic. One that can be easily done, can be done across the world, because we don't want that to be the bottleneck, but to be able to identify women that are most likely to respond means that we can actually stack the deck in our favor, in the sense that we're going to be putting in women that will have, you know, hopefully, a robust response to an oboism, so that we can blow away active control. So that's the intent.

That can be done.

It's immunohistochemistry, so it's not complicated which is a good thing for us because we don't want of complicated companion diagnostic wonder it can be one day. It can be easily done can be done across the world that we don't want that to be the bottleneck, but to be able to identify women. The most likely the response respond and means that we can actually.

Stack the deck in our favor in the sense that we're going to be putting in women that will have.

Hopefully robust response to the <unk>, so that we can blow away the active control.

So that's the intent and so.

We're not of companion diagnostic company and so for us to do something thats not in our wheelhouse doesn't make sense and so we are in discussions with companies that once we announce those companies youre going to say these guys know how they're doing and.

Mitchell S. Steiner: And so we're not a companion diagnostic company, and so for us to do something that's not in our wheelhouse doesn't make sense. And so we are in discussions with companies that, you know, once we announce those companies, you're going to say, these guys know what the hell they're doing. And this, you know, and they will be able to work.

And they will be able to work with us in parallel so of the companion diagnostic and the drugs of both available at the same time.

<unk>.

And they've done this over and over because this can do therapeutics, let them do the diagnostic.

Mitchell S. Steiner: work with us in parallel so that the companion diagnostic and the drugs are both available at the same time. And they've done this over and over because, you know, this is, you know, we can do therapeutics and let them do the diagnostic. But having a companion diagnostic also is an opportunity for laboratories to, when they, you know, breast cancer is one of those cancers that when a woman is diagnosed, she's automatically molecularly characterized, meaning that they look for the estrogen receptor, the progesterone receptor, her two negative, her two expression, in some cases, bracket one and bracket two. So the answer in the receptor can be added to that, you know, very select group. of initial molecular characterizations of breast cancer.

But the.

But having a companion diagnostic it also is an opportunity for laboratories to when the breast cancer is one of those cancers that when a woman the diagnoses automatically molecularly characterize meaning that they look for the estrogen receptor the progesterone receptor of her two negative.

For two expression in some cases bracket one of the bracket too. So the androgen receptor. It can be added in the very select group of initial molecular characterizations of the breast cancer.

The report says Oh by the way of Novo's arms available and you can answer better marketing any of that.

Than that.

Mitchell S. Steiner: And the report says, oh, by the way, Novos Arms available. Then you can't ask for better marketing than that, because then, you know, we'll be the only ones available for it. So, yes, you'll be learning at the ASCO meeting. You'll be seeing the cutoff, you know, the correlations and all that stuff. So again, we're excited because this just helps us enrich our patient population for those patients. Now, the last question somebody may ask is, well, if you do that, or you're reducing the number of patients so much that you've really reduced the number of patients in your market.

We will be dealing with available for it.

So, yes, youll be youll be learning at the <unk> meeting, you'll be you'll be seeing the cut off.

The correlations and all of that stuff so.

We're excited because this just helps us.

Enrich of our patient population for those patients now. The last question is somebody may ask as well. If you do that are you reducing the number of patients. So much of that really reduced the number of patients in your market.

On the refresh your memory, 85% of women are going to be a positive.

Mitchell S. Steiner: Well, to refresh your memory, 85% of women are going to be AR positive. And of those women, you know, even if we had half those. That's a huge population of women that will still be eligible for our AR targeted population, you know, compared to bracket 1, bracket 2 a year, it's 5% or 10%. So we're going to, you know, it's better, I think from the standpoint of having a drug that works most of the time in a good number of patients would be, would make sense.

<unk>.

And of those women.

The.

The even if we had half of those.

That's that's a huge population of <unk>.

Women debt will still be eligible for a targeted population compared to <unk> two of Youre at five of 10%.

So we okay.

I think from the standpoint of having a drug that works in <unk>.

The majority of the time and a good number of patients would be.

Makes sense.

Okay.

Chris Howardton: Okay, well that's great. I look forward to that presentation at ASCO, and thanks for taking the question. Thank you, Chris. Thank you. And the next question comes from Brandon Folks with Cantor.

That's great I look forward to that presentation of Nashville, and thanks for taking the questions.

Thank you Chris.

Thank you and the next question comes from Brandon Folkes from Cantor Fitzgerald.

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

Brandon Richard Folkes: and customer brand new folks with Cantor Fitzgerald.

Brandon Richard Folkes: Hi, thanks for taking my questions and congratulations on all the progress. Maybe firstly, just what is your degree of urgency to sell the female condom business? Obviously, it continues to do well and is well capitalized now, so any color there. And then secondly, sorry if I missed this, but on the NERBOSM phase two combination study that starts next quarter, will this be a registration study? Thank you.

Maybe first for you just.

What is your degree of urgency to sell the female condom business. Obviously, it continues to do well and well capitalized now so just any comment there and then secondly, sorry, if I missed this.

But on the of notice on phase two combination.

Combination studies of it starts.

The next quarter well this day registration study thank you.

Okay. So some of you.

Mitchell S. Steiner: Okay, so your first question is kind of where we are with the female health company business. So, as we announced, we are, you know, again, another record year. We had a record year last year, and this year looks like it's heading that way again.

Your first question, it's kind of where we already the female health company.

So as we announced.

<unk>.

We are we are again another record year, we had a record we had a record year last year. This year it looks like it's heading that way again.

And you can see from the numbers it looks it looks like to us.

Mitchell S. Steiner: And you can see from the numbers, it looks like to use any math you do. We're on a growth trajectory that is, you know, high growth. And the other thing that's important to realize is the margins that we're receiving because we've changed the business from a public sector business to a U.S. prescription business are, as you would imagine, it's more like a prescription product. And as a result, it allows us to have, and let me make more, more comments.

The math you do we're on it we are on the growth trajectory that is.

High growth.

And the other thing that's important to realize is that the margins that we're receiving because we've changed the business from the public sector business two of U S.

Prescription business is as you would imagine as more of like the prescription product.

And as a result.

It allows us to have let me make one more comment and because we're not selling the prescription product.

Mitchell S. Steiner: And because we're not selling the prescription product, using a marketing and sales sales force of 70 people or 100 people, which, you know, is eating up your profits, we spend almost no money on marketing and selling.

Using a marketing and selling sales force of 70 people of 100 people, which is eating up the cure eating eating your profits.

We spent almost no money on marketing and selling so essentially all of that money can be reinvested into our projects and so that's why we are able to run all of these projects that are cash is strong and so I think the shareholders want us to be able to invest in with multiple shots on goal in the multibillion dollar.

Mitchell S. Steiner: So essentially, all of that money can be reinvested into our projects. And so that's why we're able to run all of these projects because our cash is strong. And so I think the shareholders want us to be able to invest in multiple shots at gold in these multi-billion dollar opportunities. And to be able to have this foundation, this platform to do that is wonderful. And so we're very blessed, and we're very excited that the team has been able to do this.

<unk>.

And to be we'll have this foundation of this platform to do that is wonderful.

And so we're very blessed and we're in and we're very excited of the team is of enable to do this with that said.

Mitchell S. Steiner: With that said, you know, the best time to look for a possible alternative strategy to monetize the business is when it's doing well and it's growing. The flip side of it is, when it's doing well and it's growing, it takes a lot of pressure off the company because, you know, you're not trying to do a fire sale. You want to get the best deal that you can get.

The best time to look for a possible alternative strategy to monetize the business is when it's doing well and it's growing.

The flip side of it is it's doing well on its growing it takes a lot of pressure of the company.

Because youre not trying to do a fire sales to get you.

Do you want to get the best deals of that you can get.

Interestingly by doing a successful fundraiser debt we did.

Mitchell S. Steiner: Interestingly, by doing a successful fundraiser that we did back in February, it put enough resources in the bank that we're also in a position that we don't have to take any deal that comes in for the female health company because we have the resources to keep going. So I think we put ourselves in the best position to monetize this at the best, best price for shareholders and not put ourselves in any time strain or any other, I mean, we're in the driver's seat.

Okay back in February it put enough resources in the bank debt. We're also in a position that we don't have to take any deal that comes in for the female health company because we have the we have the resources.

Just to keep going so.

So I think we've put ourselves in the best best position to monetize this at the best best price for shareholders.

And not put ourselves in any time strain.

Any.

When the driver's seat so from that standpoint, what I can tell you is there is a lot of activity.

Mitchell S. Steiner: So from that standpoint, what I can tell you is there's a lot of activity, and we continue to explore all kinds of options. And because we're not stressed for time, because we have the money, and we're moving forward, we're going to do this in a way that's best for the shareholders.

And we will continue to explore all kinds of options and because we're not we're not stretched for time, because we of the money and we're moving forward.

We're going to do this in a way that's best for the shareholders.

As it relates to your second question.

Mitchell S. Steiner: As it relates to your second question, is anobos arms a second indication? It actually is a second indication. So, you know, the FDA said you're going to do a combination therapy. There are a lot of things you have to do with combination therapies, and that's at first to make sure that there's safety in the combination therapies. And so that's really a separate program.

Which is of Novus arms.

Second indication second it actually is the second indication so the.

The FDA said you can do a combination therapy. There is a lot of things you have to do with combination therapies and that's the first is to make sure that the safety and the combination therapies.

And so that's really a separate program and so we decided that based on the Fda's response that the easiest thing to do is the <unk> monotherapy in the third line setting we have the data.

Mitchell S. Steiner: And so we decided, based on the FDA's response, that the easiest thing to do is Novosar monotherapy in a third-line setting. We have the data. You know, we treated heavily pre-treated women that have failed estrogen receptor blocking agents and 12% failed CDK-4-6 inhibitors. You see good activity, pre-clinical data. So we're good to go with our test phase three. But, boy, wouldn't it be nice to move in earlier in a second line setting?

We treated the heavily pre treated heavily pre treated women that have failed estrogen receptor blocking agents in the 12% sales CDK for six inhibitors you see good activity preclinical data. So we're good to go with our test phase III the.

Boy wouldn't it be nice to move in earlier in the second line setting so that means of 83% of patients are coming in with ER positive breast cancer.

Mitchell S. Steiner: So that means if 83% of patients are coming in with ER positive breast cancer, and they're getting treated with a CDK-4-6 inhibitor, which is almost predominantly palbo, palbo-siclid, and an estrogen receptor-targeted agent, whether it's a non-storey eye or fovestrine, What did you do after they fail? So, you know, initially we were told this is a crowded space There's a lot of drugs trying to get into the space.

And they are getting treated with a CDK for six inhibitor of which almost almost.

Predominantly as Paolo tableau sick live and in necessarily share of the targeted agent with us of non store layout or for investment.

What do you do after they fail so that.

Initially we had hoped we were told this is the.

This is a crowded space, there's a lot of drugs trying to get into the space, but literally overnight because of CDK for six inhibitors that crowded space has become less crowded.

Mitchell S. Steiner: But literally overnight, because of CDK-4-6 inhibitors, that crowded space has become less crowded because of the fact that after first-line therapy, the majority of women are looking for something that has not been proven. So the phase two that we're doing is, we're not thinking of it as a registration trial. We think that phase two in a second line setting is to provide us with the information we need to confirm it in a phase three study.

Because the <unk>.

Cause of the fact that after the first line therapy. The majority of women of looking for something that has not been proven.

So.

So the so the phase two that we're doing.

Is.

Is.

It's not a we're not thinking of it as a registration trial, we're thinking of the phase two.

On a second.

The second line setting is to provide us the information we need to confirm it and the phase III study.

Brandon Richard Folkes: Thanks, that's very helpful, and congratulations again on all the progress. Thank you. And the next question is going to St. Louis, then, Oppenheimer.

Thanks, that's very helpful and congrats again on all of the progress.

Thank you.

Thank you and the next question you also I believe on Garceau with Oppenheimer.

Yes.

Leland.

Mr. <unk> your line is live.

Leland James Gershell: Your line is live. Oh, sorry, I'm unmuted now.

On the needed now.

When it makes the Inc.

Leland James Gershell: Thank you very much. Thank you. And thanks for the comprehensive update on all your plans. Just a quick question, just really quick.

Thank you.

And thanks for the comprehensive update on on all your plans.

Just a quick question just really of clarifications. So the exploratory arm with CDK for six inhibitor that you had contemplated.

Leland James Gershell: So the exploratory arm with CDK-4-6 inhibitor that you had contemplated for that our test study is no longer needed.

For that our test study is no longer going to be included in our test correct. You see the coordinate combination will be restricted only to the.

Leland James Gershell: is no longer going to be included in our test, correct? Your CD4K combination will be restricted only to

For the phase two or will you be keeping that exploratory phase three as well.

Leland James Gershell: phase two, or will you be keeping the exploratory in phase three as well? No, no.

No no. So we moved the exploratory arm out of the phase III sort of the phase III, then becomes simpler easier and as you know every time you add an additional arm it's in the other statistical hurdle.

Mitchell S. Steiner: So we moved the exploratory arm out of phase three. So phase three then becomes simpler, easier. And, you know, as you know, every time you add an additional arm, it's another statistical hurdle.

So the idea was just make it clean two of <unk> mono therapy.

Mitchell S. Steiner: So the idea was just to make it clean to anobosar monotherapy versus, you know, another after a rocking agent, which these women have failed several times with. And so it's a good control for us to go up again. And third line setting, you know, these women would have exhausted all these things.

Vs.

Vs.

Another.

Blocking agent, which is women had sales tablet.

And so it's a good control for us to go up again.

And third line setting all of these women would have exhausted all of these things and so it is pre chemo and our side effect profile looks pretty good it looks like an endocrine therapy. It's not of chemotherapy. There is no diarrhea, vomiting in hair loss and all of that stuff and so we feel that that's of great spot for us to be but to me.

Mitchell S. Steiner: And so it's good, it's pre-chemo, and, you know, our side effect profile looks pretty good. It looks like an endocrine therapy. It's not chemotherapy. There's no diarrhea, vomiting, and hair loss and all that stuff.

Mitchell S. Steiner: And so we feel that that's a great spot for us to be, but to move in earlier. That was our thinking, if we're going to do combination therapy, because one of the things the agency asks for is that if you can do combination therapy, you just can't say, I'm going to do a CDK-46 inhibitor and an estrogen receptor blocking agent. They want you to specifically name CDK-4-6 inhibitor. That kind of makes sense, right?

Move into earlier.

That was our thinking of going to combination therapy, because one of the things of the agency asked for is that if you pick. If you can do combination therapy, you just can't say I'm going to do CDK for six inhibitor and an estrogen receptor blocking agent. They want you to specifically name CDK <unk> inhibitor like kind of makes sense right. Because if you look of the CDK for six inhibitor.

Mitchell S. Steiner: Because if you look at the CDK-4-6 inhibitors, palbolicl has a different safety profile than, for example, ribosycle. And so one of the reasons why Palbo's used so much and is the leader is because of its safety profile and because it was first to market. So that's why in phase two, in the combination program, which is in phase two, we're very specific. Since Palo is being used 80% of the time in first line, then we're going to come in with Bemisiclid plus an ovusarm and go up against, you know, standard right now, which is another estrogen receptor blocking agent. And that, you know, my gosh, can you imagine if we're in a second line setting and move an obisarm earlier? So they're very separate programs.

<unk>.

<unk> has a different.

The safety profile of them for example of <unk>.

And so the one of the reasons why <unk> used so much and then as the leader is because of its safety profile and because it was first to market.

So thats why in the phase two.

In the in the combination program, which in the phase II, we're very specifics since it powerboats being used 80% of the time in first line.

Then we're going to come in with the Derma sets a cyclic plus in overtime.

And go up against.

The standard right now, which is another estrogen receptor blocking agents.

My God can you imagine if were in the second line setting.

And moving to <unk> arm earlier, so they are very separate programs of phase III programs in phase III program for the third line setting phase II program to go in the earlier and I think we'll get a lot of credit for good phase II data.

Mitchell S. Steiner: A phase three program for a third line setting, phase two program to go in earlier. And I think we'll get a lot of credit for good phase two data because then, at that point, you're just going to confer. in your phase three. So, essentially, what we've done is we just increased the depth and breadth of the nose arm program. And there'll be other indications that we'll be able to go into that we'll announce later.

Because of then at that point of just kind of confirming your phase III. So so essentially what we've done is we just increase the depth and breadth of the <unk> program.

And there'll be other indications that we'll be able to go into the we will announce later, but when you're when you're the only the only game going after the androgen receptor, which is there in some cases more prevalent in the estrogen receptor in breast cancer.

Mitchell S. Steiner: But, you know, when you're the only game going after the antin receptor, which is, in some cases, more prevalent than the estrogen receptor and breast cancer, then, you know, we have to continue to explore how we're going to build the indications for the drug. Yeah.

Then we have we have to we have to.

The continued to explore how we're going to build the indications for the for the the drug.

Got it makes sense and then just a follow up with what the Tolerability of the nobles arm.

Leland James Gershell: That makes sense. And then just to follow up, you know, with the tolerability of a nobiz arm, any thoughts kind of on a maintenance type? Yeah.

And your thoughts kind of on a maintenance type on these patterns on the line of patients who may.

Leland James Gershell: use pattern down the line, patients who, you know, get through sort of an initial treatment period, and then they can stay on.

Debt through sort of the initial treatment period, and then they can stay on it.

And it goes on maintenance and you're thoughtful.

Leland James Gershell: So you're talking about in the trial, or you're talking about in real life? No, no, no, in the real, real world.

So you're talking about in the trial of a ton of the real life No no no.

Real real world.

On the real World.

Mitchell S. Steiner: Yeah, yeah, so in the real world, since we're using radiographic progression-free survival as the end point, then the patient gets to stay on until they progress. So it won't be like induction chemotherapy followed by maintenance chemotherapy because it's an endocrine therapy. How is it any different than tamoxifen being used for five years or an aromatase inhibitor being used for three to five years? So if we're fortunate, the treatment will be, you know, alongside the patient for as long as the patient is stable or benefiting from it.

Since were using radiographic progression free survival of the endpoint.

And then the patient gets the stay on it until the progress. So so so it won't be like induction chemotherapy, followed by maintenance chemotherapy because of its an endocrine therapy, how is it any different than tamoxifen being used for five years or.

Or an aromatase inhibitor being used for three to five years. So so if we're fortunate.

On the treatment would be alongside the patients for as long as the patient is stable.

Or benefiting from it and so we don't have to do any maintenance studies. It will be we will continue to take until the it's almost similar to some of the.

Mitchell S. Steiner: And so we don't have to do any maintenance studies. It'll be, you know, they'll continue to take it until it's almost similar to some of the cytostatic drugs like the tyrosine kinase inhibitors where patients are on them for a while, even in lung cancer.

Side of static drugs like the tyrosine kinase inhibitors.

Patients on for a while even in lung cancer.

Leland James Gershell: Yep, okay, great. Thanks very much for taking the questions.

Yeah, Okay, great. Thanks, very much for taking the questions.

Thank you Lou and I appreciate it.

Leland James Gershell: Thank you, Louan. I appreciate it.

Thank you and the next question comes from some of our raws on with Brookline capital markets.

Mitchell S. Steiner: Thank you. And the next question comes from Kamar Raja with Perkline Capital Market. Congratulations and thanks for taking my questions. With regard to COVID-19 trials and given the variability in standard of care with regard to different regions, how do you think that is going to impact the results? And it also looks like you are going with a 60-day endpoint in phase three compared to the 29-day. What are the factors driving this? Yeah, so the first question.

Congratulations on thanks for taking my questions with.

With regard to COVID-19 trial.

And given the variability of standard of care with regard to different regions how.

How do you think of.

That is going to impact the results.

And also it looks like Youre going with the 60 day end point at the phase III comfort for the 2019 day.

What are the fact of the driving piece.

Yes. So the first question has to do with the recruitment and potential effect on recruitment.

Kamar Raja: Yeah, so the first question has to do with recruitment and potential effect, recruitment, I guess, geography, and potential effect on the result. It's a very good question. And so from that standpoint, you know, in the United States, we still have several sites in the U.S. that are opening up. And the United States is weird.

Guess geography and potential for effect on the result.

It's a very good question and so so from that standpoint.

In the United States, we still have several sites in U S. The we're opening up and do your line is weird, it's become almost like a checkerboard, where some some areas look fine and some areas of nice fine and so so even though we're thinking we're getting out of it in the U S. If you look at it we're still between 39% and 50000 K.

Mitchell S. Steiner: It's become almost like a checkerboard where some areas look fine, and some areas are not. And so even though, you know, we're thinking we're getting out of it in the U.S., if you look at it, we're still between 39 and 50,000 cases a day, and you still have a death rate that is, you know, significant. And so I don't know how long that's going to go, but we're, you know, we're in a position given to phase two to take advantage of that.

Misses a day and you still have the death rate is significant.

And so I don't know how long that's going to go but we're we're in position given the phase II.

To take advantage of that so in the U S.

Mitchell S. Steiner: So in the U.S. Now, one of the reasons why we picked, instead of ICU days and all that stuff which we were going to measure, we picked mortality. Why did you pick mortality? We picked mortality because you can't fake a death.

Now one of the reasons why we picked.

Of ICU days, and all of that stuff, which you will get a measure we pick the mortality.

Why did you pick mortality, we pick mortality because you can't fake of death.

So the patient dies, you can count that pretty easily if a patient has respiratory failure or is it respiratory failure because of the standard of care is the best place, they're very because the failure because they couldnt get oxygen.

Mitchell S. Steiner: So if a patient dies, you can count that pretty easily. If a patient has respiratory failure, is it respiratory failure because of the standard of care? Is it respiratory failure because they couldn't get oxygen?

As of days in the hospital, because they needed that bad because of the sicker patients I mean, there's too many other variables that go into some of these other endpoints that people use in the COVID-19 studies since we're going after the hospitalized patients.

Mitchell S. Steiner: You know, are they days in the hospital because they needed that bed because they were sicker patients? I mean, there are too many other variables that go into some of these other endpoints that people use in the COVID-19 studies. Since we're going after hospitalized patients with a WHO score of five or greater, by definition, these are the sickest patients, and death is a pretty good endpoint to determine whether your medicine is working or not.

With the <unk> score of five of greater by definition of these of the sickest patients and depth of pretty good endpoint to determine whether <unk> medicines of work is working or not so even if we go into other geographic locations.

Mitchell S. Steiner: So even if we go into other geographic locations, like Brazil, Mexico, Argentina, and Colombia, as I mentioned. And hospitals, by the way, in those countries are good enough. And, you know, we think that, you know, and again, of course, the FDA will always make you look at each region and how it contributes, but we think we'll be okay. We have to back up in Europe, as you know, Europe is about to go through another surge, and so we do have backup if we need to.

Brazil, Mexico, Argentina, and Colombia, as I mentioned.

And the hospitals by the way in those countries are good enough.

<unk>.

We think that.

And again of course of the FCA will always make you look at each region and how it contributes but we think we'll be okay.

We have some backup in Europe as you know Europe is about to go through another surge and and so we do have backup because we need to we're going to be incredibly aggressive in making sure. We fill this trial by year end.

Mitchell S. Steiner: We're going to be incredibly aggressive in making sure we fill this trial by year end. And so I think we're going to be fine because of the endpoint in terms of different geographies, but we will, you know, we will look at each geography and its contribution to the final answer at the end of the study. As it relates to 60 days versus 29 days looking at a mortality endpoint, we picked 29 days because the FDA picked 29 days, and if you look at almost every study that was done contemporarily, it was 29 days.

And so I think we're going to be fine because of the endpoint.

In terms of different geographies, but we will we will look at each geography and their contribution to the final answer.

At the end of the study.

As it relates to 60 days versus the 29 days looking at of mortality endpoint.

We picked 2009 days because of the FDA pick 29 days and if you look at almost every study was done can temporarily it was 29 days.

It turns out that.

Mitchell S. Steiner: It turns out that we want to capture as much good information as we can, and what we've learned in our study is that if patients are not doing well, you're going to catch most of them by day 29. But, boy, it would be nice to see whether or not we have a benefit beyond that. And so day 60 is really what was in our previous study, our safety window. So the idea is if you capture it for 60 days, and death is an end point, and a patient is in respiratory failure, and they're able to keep him alive a little bit longer past day 29, but then he dies at day 35 or day 40. And he's in a placebo group. You want to capture that, and so I think what it will do is we'll make the mortality data more robust.

We want to capture as much good information as we can.

And what we've learned in our study is.

If patient if patients were not doing well youre going to capture most of them by day 29, but boy Oh boy it would be nice to see whether or not we have of benefit beyond that and so day 60 is really was in our previous study our safety window. So the idea is if you can.

Capture of for 60 days and death as an endpoint and the patient is in the respiratory failure and they were able to keep them alive, a little bit longer past day 29, but then the dies of day.

The 35, a day 40.

An easing of the placebo group do you want to capture that.

And so I think what we'll do is we'll make the mortality data more robust.

Kamar Raja: Thank you. And the next question comes from Yi Chan with H.C. Wainwright. Thank you for taking my questions. Just to clarify, is this the first time for the 9 milligram and 32 milligram dose formulation of Zebulin to be used in their respective patients?

Okay, great. Thank you.

Thank you.

Thank you and the next question comes from the channel with H C. Wainwright.

Thank you for taking my questions.

Just to clarify is this the.

First time for the nine milligram 32 milligram dose formulation of <unk>.

So for example to be used irrespective of patient groups.

Yi Chen: respective patients. Yeah, so it'll be the first time for those formulations. But those formulations were bridged with a PK study that we did in the phase two study in prostate, where we looked at the 63 milligram dose blood levels compared to the to be marketed phase three dose forms. And based on those data, which showed bioavailability was 100% better than what it was before. Then we went to the agency, and the agency reviewed the formulations and agreed that the doses that we picked for the phase 3 studies were acceptable given what we learned in the PK study in phase 2.

Yeah.

Yeah, so it'll be the so it will be the first time for those formulations, but those formulations were bridged with the PK study that we did in the phase two study in prostate where we looked at the 63 milligram dose.

Blood levels compared to the to be marketed.

The phase III dose forms.

And based on those data which showed.

By availability was 100% better than what it was before then we went to the agency and the agency review the formulations and agreed that the doses that we picked for the phase III as well.

For acceptable given what we've learned in the PK study and the phase II.

So.

Yi Chen: So the answer is, yeah, it's the first time we're using those formulations, but we also know what the drug levels are going to be, and the drug levels are going to be consistent with what we did in the phase 2s. So the 9 milligram will be similar to the 18 milligram for COVID-19, and the 32 milligram is similar to the 63 milligram dose that we used in the phase 1B2 process

So the answer is yes, it's the first time of using those formulations, but we also know.

We know the drug levels of going to be in the drug levels is going to be consistent with what we did in the phase twos. So the nine milligram will be similar to the 18 milligram for COVID-19, and the 32 milligram is similar to the 63 milligram dose that we used in the.

Phase one b to prostate.

Mitchell S. Steiner: Got it, thanks. My second question is, how are the operating expenses going to trend with multiple trial initiations throughout the...

Got it thanks.

My second question is on the Euro.

<unk> expense is going to turn him it was multiple trial initiations throughout this year.

Lots of your first part of your question say it again please.

Yi Chen: I lost the first part of your question. Say it again, please.

Oh of the offer.

Yi Chen: How are the operating expenses going to trend with multiple trial initiation?

Operating expenses going to term loans multiple trial initiations.

All right. Good question. So Michelle do you want to answer that question.

Yi Chen: All right, good question. So Michelle, do you want to answer that question?

Michele Greco: Sure. You know, we've indicated that our drug expense has increased. For this period, let me go over those numbers there. You know, our R&D expense went up a quarter from 3.9 last year to 7.5, and for the six months from 9.2 to 13.5. You know, they're going to continue to increase. Again, this quarter we are at 7.5. We're going to continue to increase those as we continue to add all these trials that Dr. Steiner just went over on the call that will be going on and being added over this calendar year. So they're going to continue to...

Sure.

We've indicated that.

Alright.

Expenses increased.

For this period.

Those numbers debt.

Yeah.

Our R&D expense went up.

Quarter from $3 nine last year, seven five and for.

For the six months down in line to debt.

$13 five.

They're going to continue to increase again this quarter, we were at seven five.

Going to continue to increase those as we continue to add all of these trials debt.

Standard just went over on the call on.

That will be going on.

Being added over this the key.

Calendar year.

Michele Greco: Okay, thank you. Yep. Thank you. Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks.

So they're going to continue.

On to slowly increase.

And yes.

Yep.

Okay.

Okay.

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

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

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

Thank you for digitally of play of the conference call will be available beginning approximately noon eastern time today May 12, probably the only 18773 or four for sub 529 in the U S and one for 123 of 170088 internationally.

Operator: Thank you. The digital replay of the conference call will be available beginning at approximately noon eastern time today, May 12, by dialing 1877-347-3529 in the U.S. and 1-412-08-88 internationally. You'll be prompted to enter the replay access code, which will be 1015-4431. Please record your name and company when joining. The conference has now concluded. Thank you for attending today's discussion.

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Please record your name of company when joining the.

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Yeah.