Q1 2021 Veru Inc Earnings Call

Okay.

Good morning, ladies and gentlemen, and welcome to their true Inc. Investors Conference call all participants will be in listen only mode.

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

Should you need assistance. Please signal a conference specialist by pressing the Starkey followed by zero.

Operator: Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch.

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

I would now like to turn the conference over to Mr. Sam Fisch.

<unk>, Inc. 's director of Investor Relations. Please go ahead.

Samuel Fisch: Inks, Director of Investor Relations. Please go ahead. Good morning. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding the company's business, operations, finances, and product portfolio.

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

Forward looking statements may include but are not necessarily limited to statements of the company's plans objectives expectations or intentions regarding the company's business operations finances and <unk>.

The portfolio.

Such forward looking statements are subject to known and unknown risks uncertainties.

Samuel Fisch: Such forward-looking statements are subject to known and unknown risks and uncertainty, and the company's actual results may differ significantly from those projected, suggested, or included in any forward-looking statement. Risks that may cause actual results or developments of different materials are contained in the company's 10-Q and 10-K SEC files. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO, and President. Thank you, Sam, and good morning.

And the company's actual results may differ significantly from those projected suggested or included and any forward looking statements.

The risks that may cause actual results or developments of differ materially are contained in the in the company's 10-Q, and 10-K and SEC filings.

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

The <unk>, chairman and CEO and President. Thank you Sam and good morning with me on this morning's call and Michele Greco CFO and CEO, Dr. Gary Barnett, Chief Scientific Officer, Phil Greenberg Executive Vice President legal and Sam Fisch, who you've met the director of Investor Relations. Thank you for joining our call.

Mitchell S. Steiner: With me on this morning's call are Michele Greco, CFO and CAO, Dr. Gary Barnett, Chief Scientific Officer, Phil Greenberg, Executive Vice President, Legal, and Sam Fisch, who you've met, Director of Investor Relations. Thank you for joining our call. Veru is a late-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 high-value oncology drug candidates so that our current shareholders can realize the maximum value of our oncology biopharmaceutical company.

Zero as of late clinical stage oncology.

The pharmaceutical 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 and to the clinical development of our high value oncology drug candidates. So that our current shareholders can realize the maximum value of our oncology biopharmaceutical company.

This morning, we will discuss another record quarter of our sexual health business, the progress of our prostate cancer and breast cancer drug pipelines.

Mitchell S. Steiner: This morning, we will discuss another record quarter from our sexual health business, the progress of our prostate cancer and breast cancer drug pipelines, Vera 111 for the treatment of COVID-19, the upcoming NDA submission for Tad Finn, and then we will provide financial highlights for our record first quarter fiscal year 2021. Let's now focus on some of the financial highlights from Veru's sexual health business. We had net revenues in the USFC2 prescription business in Q1 of fiscal year 2020 of $9.1 million, compared to $6.1 million in Q1 of fiscal year 2019, which is up 50%.

For 111 for the treatment of COVID-19, the upcoming NDA submission for the end of a Taxane and then we will provide financial highlights for our record first quarter of fiscal year 2021.

Let's now focus on some of the financial highlights and various sexual health business, we had net revenues and the U S. F. C. Two prescription business and Q1 of fiscal year, 'twenty and 'twenty of $9 1 million compared to $6 1 million and Q1 fiscal year 2020, which is up 50% and that should be Q1 fiscal year 2021.

Mitchell S. Steiner: That should be Q1 fiscal year 2021 of $9.1 million, compared to $6.1 million in Q1 of fiscal year 2020, which is up 50%, fiscal year 2021 was $10.8 million compared to Q1 fiscal year 2020 of $7.3 million, which, Operating income was $19.2 million, which includes a gain of $18.4 million on the sale of the pre-boost business, and the adjusted operating income, which excludes the gain on the sale of pre-boost, was $800,000 in Q1 fiscal year 2021, compared to an operating loss of $1.8 million in Q1 fiscal year 2020.

At $9 1 million compared to $6 1 million and Q1 fiscal year 2020, and he is up 50% gross profit for Q.

Q1 fiscal year, 2021 was $10 $8 million compared to Q1 fiscal year 2020 of $7 $3 million, which is up 49% operating income was $19 $2 million, which includes the gain of $18 4 million.

On the sale of the free Booze business and the adjusted operating income, which excludes the sale the gain on the sale of pre boost the $800000 and Q1 fiscal year 2021, compared to an operating loss of one $8 million and Q1 fiscal year 2020, and fact to give you a sense of our continuation of.

Mitchell S. Steiner: In fact, to give you a sense of our continuation of the growth trajectory, for Q1 fiscal year 2020, we sold 81,000 units of FC2 in the U.S. prescription market, while in Q1 fiscal year 2021, we sold 116,000 units of FC2 in the U.S. prescription market, an increase of 43 percent. Tadfin, which is Tadalafil 5 mg of finasteride 5 mg combination capsule, is being developed to treat lower urinary tract infections caused by benign prostatic hyperplasia. It contains both Tadalafil, which is also approved for the treatment of erectile dysfunction, and finasteride.

The growth trajectory for Q1 fiscal year 2020, we sold 81000 units.

<unk> and the U S prescription market, while Q1 fifth of fiscal year 2021, we sold 116000 units of the FC too.

And the use of prescription market and increase of 43%.

Net thin, which is tadalafil five milligrams of finasteride five milligrams combination capsule is being developed to treat lower year on a track infections caused by benign prostatic hyperplasia and it contains both Tadalafil, which is also approved for the treatment of erectile dysfunction and finasteride, we expect the submit the NDA for tap and next week we are.

Mitchell S. Steiner: We expect to submit the NDA for Tadfin next week. We have also received a waiver for the FDA PDUFA fees for this NDA submission in the approximate amount of $2.4 million. We plan to launch Tadfin, if approved, via third-party telemedicine channels and when launched, it will be a near-term source of additional revenue for Veru. In oncology, we are focused on providing new and novel oral therapies with favorable safety profiles following resistance to endocrine therapy but prior to proceeding to IV chemotherapy for both advanced prostate and breast cancer.

Also received a waiver for the Baidu for FDA could do for fees for this NDA submission and the approximate amount of $2 $4 million. We plan to launch <unk>. If approved via third party telemedicine channels and when launched will be a near term source of additional revenue for <unk>.

And oncology, we are focused on providing new and novel oral therapies with favorable safety profile of <unk> following resistance to endocrine therapy. The prior to proceeding to IV chemotherapy for both advanced prostate and breast cancers.

We are excited to advance our prostate cancer drug candidates fear of 111 of your 100 and as well as our breast cancer drug candidates and <unk> and the additional indication for <unk> hundred one weapon into registration and clinical Studies Bureau, anticipates registration clinical trials for the for oncology indications and the additional registration clinic.

Mitchell S. Steiner: We're excited to advance our prostate cancer drug candidates, Veru111 and Veru100, as well as our breast cancer drug candidates, Enobisarm, and the additional indication for Veru111, into registration clinical studies. Veru anticipates registration clinical trials for four oncology indications and the additional registration clinical trial for Veru111 for COVID-19, making a total of five potential registration clinical trials in all to commence in calendar year 2021. In prostate cancer, the company continues to make strong clinical progress advancing Vero111 as a treatment for metastatic castration and androgen receptor-targeting agent-resistant prostate cancer and Vero100 as androgen deprivation therapy for advanced prostate cancer.

The trial for fear of 111 for COVID-19, making a total of five potential registration clinical trials and all to commence and calendar year 2021.

And prostate cancer. The company continues to make strong clinical parka progress advancing bureau of one weapon as a treatment for metastatic castration and androgen receptor targeting agent resistant prostate cancer and severe 100 for androgen deprivation therapy for advanced prostate cancer.

One of 11 and oral first in class of new chemical entity, the targets cross links and the swaps the alpha and beta tubular and subject SAP units of microtubules to disrupt decided the skeleton.

Mitchell S. Steiner: Vero111 is an oral first-in-class new chemical entity that targets, cross-links, and disrupts the alpha and beta tubulin subunits of microtubules to disrupt the cytoskeleton. Bureau 111 is being evaluated in open-label Phase 1b and Phase 2 clinical studies in men with metastatic castration and androgen receptor-targeting agent-resistant prostate cancer. The Phase 1b clinical study completed enrollment of 39 men and is ongoing. The Phase 1b study has yielded promising efficacy and safety clinical results. Based on the Phase 1b study results, the recommended Phase 2 dose is 63 milligrams oral daily continuous dosing for 21 day cycles. Daily chronic drug administration appears feasible and safe.

Bill one of elevens being evaluated in the open label Phase <unk> and phase II clinical studies and men with metastatic castration and androgen receptor targeting agent resistant prostate cancer the phase <unk> clinical study completed enrollment.

Of 39 men and that's ongoing the phase <unk> study has yielded promising efficacy and safety clinical results based on the phase <unk> study results of the recommended phase II dose of 63 milligrams oral daily dose of continuous dosing for 21 day cycles daily chronic drug administration appears feasible and sales.

And the recommended phase two dose and when.

Mitchell S. Steiner: At the recommended Phase 2 dose, there were no reports of neutropenia, neurotoxicity, or grade 3 diarrhea. The efficacy results showed PSA declines in responses as well as objective and durable tumor responses. Furthermore, median radiographic progression-free survival in the men who have had at least, In September of 2020, the Phase II clinical study completed enrollment of approximately 40 men with metastatic castration-resistant prostate cancer who have also become resistant to the antireceptor-targeting agents but prior to proceeding to IV chemo. Although the study is still ongoing, Daily chronic drug administration also continues to be feasible and safe.

No reports of neutropenia, neurotoxicity or grade three diarrhea, the efficacy results show PSA declines and responses as well as objective and durable tumor responses. Furthermore, median and radiographic progression free survival and the men who have had at least for cycles. If you're one of 11 is $12 for.

Months, they're still Threep and on the study with two patients approaching two years without prostate cancer progression.

In September of 2020, the phase III clinical study and complete enrollment of approximately 40 men with metastatic castration resistant prostate cancer, who have also become resistant to the annual receptor targeting agents, but prior to proceeding to IV chemo.

The other studies still ongoing Dale.

Daily chronic drug administration also continues to continues to be feasible and safe at.

And at 63 milligrams daily continuous dosing due and no reports of neutropenia. There's a single report of mine of neurotoxicity and manageable and fewer cases of diarrhea like the phase one b. We have we have observed efficacy results, including PSA declines and responses as well as objective and durable response tumor response.

Mitchell S. Steiner: At 63 mg daily continuous dosing, there were no reports of neutropenia, a single report of minor neurotoxicity, and manageable and fewer cases of diarrhea. Like in Phase 1b, we observed efficacy results, including PSA declines and responses, as well as objective and durable tumor responses, including complete and partial responses. Thus, in the Phase 2 clinical study, Veru-111 continues to show objective anti-tumor activity and a good safety profile. We will be presenting updated clinical results of the Phase 1b, as well as the Phase 2 clinical trials at the ASCO Genitourinary Cancer Symposium, taking place February 11 through 13, 2021. The abstract is 325053, Clinical Study of VIRA-111, an oral cytoskeleton disruptor in metastatic castration-resistant prostate cancer patients who have failed an antigen-receptor-targeted agent.

Including complete and partial responses.

And the phase II clinical study <unk> 111 continues to show objective antitumor activity and a good safety profile.

We will be presenting updated clinical results of the phase <unk> as well as the phase II clinical trials of the ESCO genital genital urinary cancers symposium, taking place February of 11 through the 13th.

And in.

And 2021 and the abstract is three to 5053 clinical study of Euro of one of the weapon and oral side of Skelton disruptor, and metastatic castration resistant prostate cancer, who have failed an androgen receptor targeted agent and the <unk> presentation will be done by Dr. Mark and makowski He's assistant professor.

Mitchell S. Steiner: The presentation will be done by Dr. Mark Markowski, who is Assistant Professor of Oncology at Johns Hopkins Kimmel Comprehensive Cancer Center and a Principal Investigator on the study. As we already have enough safety and efficacy data to select a dose for Vero111 and proceed to Phase 3, the company had an FDA meeting in July of 2020 and received positive input from FDA on the pivotal Phase 3 trial design for Vero111. The company received regulatory clarity that the indication for treatment in men with metastatic castration-resistant prostate cancer who have failed one androgen receptor targeting agent prior to IV chemotherapy was acceptable, that an open-label randomized study using an alternative androgen receptor targeting agent as the active control is reasonable, and that the primary endpoint may be radiographic progression-free survival.

Of oncology as Johns Hopkins Kimmel comprehensive cancer Center and the principal investigators on the study.

As we already have enough safety and efficacy data and select the dose of Euro of one of 11 and proceed to phase III. The company had an FDA meeting in July of 2020 and received positive and put some FTA on the pivotal phase III trial design for the Bureau of one of the 11th the company received regulatory clarity that the indication of treatment of men.

And with metastatic castration resistant prostate cancer, who have failed one androgen receptor targeting agent. The prior to IV chemotherapy was acceptable that and open label randomized study using an alternative androgen receptor targeting agents.

For the active control is reasonable and that the primary endpoint may be radiographic progression free survival.

By allowing radiographic progression free survival as the primary endpoint the sample size of the phase III study is planned for approximately 240 men. The phase III pivotal clinical study will evaluate the bureau of 111 for men with metastatic castration resistant prostate cancer and we've also become resistant to one of the androgen receptor targeting agent.

Mitchell S. Steiner: By allowing radiographic progression-free survival as the primary endpoint, the sample size of the Phase 3 study is planned for approximately 240 men. The Phase III Pivotal Clinical Study will evaluate Veru-111 for men with metastatic castration-resistant prostate cancer who have also become resistant to one androgen receptor targeting agent and will be called the Veracity Phase III Study. The company has submitted the Phase III protocol designed to FDA for its input and anticipates starting the Veracity Phase III Study in the first quarter of calendar year 2021.

And we will be called the veracity of Phase III study. The company has submitted the phase III protocol designed to FTA for input and anticipate starting the veracity phase III study and first quarter of calendar year 2021.

It is interesting to note that we have a real opportunity severe one of 11 to be the leader and the pre chemotherapy space and metastatic prostate cancer by pursuing the indication of the treatment of metastatic castration and.

Mitchell S. Steiner: It is interesting to note that we have a real opportunity for VERA-111 to be the leader in the pre-chemotherapy space in metastatic prostate cancer by pursuing the indication of the treatment of metastatic castration and androgen receptor-targeted agent-resistant prostate cancer. Use of antigen receptor targeting agents has moved earlier in the treatment sequence of advanced prostate cancer.

And Andrew and reset the targeted agent resistant prostate cancer.

Use of androgen receptor targeting agents have moved earlier and the treatment sequence of advanced prostate cancer. The two currently approved indications for the antibody type of targeting agents are for.

Mitchell S. Steiner: The two currently approved indications for the antigen receptor targeting agents are for hormone-sensitive metastatic prostate cancer and for non-metastatic castration-resistant prostate cancer. When patients progress or fail an angioreceptor-targeted agent in both these settings, they will now have metastatic, castrate-resistant, and angioreceptor-targeted agent-resistant prostate cancer, the very indication we're pursuing in the Phase III clinical trial.

For a month's sensitive metastatic prostate cancer and for the non metastatic castration resistant prostate cancer when patients progress of fail and Andrew and receptor targeted agent. Both of these settings. They will now have metastatic castrate resistant and Andrew.

And the androgen receptor targeted agent resistant prostate cancer, the very indication, we're pursuing and the phase III clinical trial.

So all roads lead to this indication net.

Next I will update you on drew 100 has androgen deprivation therapy for the palliative treatment of advanced prostate cancer.

Mitchell S. Steiner: Next, I will update you on VERU100 as Androgen Deprivation Therapy for the Palliative Treatment of Advanced Prostate Cancer. Vero 100 is a novel, proprietary, long-acting, gonadotropin-releasing hormone, GnRH antagonist peptide, three-month, subcutaneous depot formulation designed to address the current limitations of commercially available androgen deprivation therapy known as ADT. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the disease.

And you are 100 is a novel proprietary long acting gonadotropin, releasing hormone gnrh antagonist peptide three month subcutaneous depot formulation designed to address the current limitations of commercially available androgen deprivation therapies known as ADT.

Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as the foundation of treatment throughout the course of disease. Furthermore, ADT has continued even as other endocrine chemotherapy or radiation treatments of added or stopped.

Mitchell S. Steiner: Furthermore, ADT is continued even as other endocrine, chemotherapy, or radiation treatments are added or stopped. There are no GnRH antagonist deprotectable formulations commercially approved for the treatment beyond a one-month duration. A phase 2 study to evaluate Veru 100 dosing is anticipated to begin in the first half of calendar year 2021, and a phase 3 registration study in approximately 100 men is anticipated to start in the second half of calendar year 20

No Gnrh antagonist Depo injectable formulations commercially approved for the treatment beyond the one month duration.

A phase II study to evaluate for 100 dosing is anticipated to begin in the first half of calendar year 2021, and the phase III registration study and approximately 100 men is anticipated to start and the second half of calendar year 2021.

Next I will discuss the progress of our breast cancer drug pipeline, which includes the notebooks arm and Bureau of 111.

Mitchell S. Steiner: Next, I will discuss the progress of our breast cancer drug pipeline, which includes Phenobazarm and Vuru111. The most common type of breast cancer is ER-positive breast cancer, where estrogen is one of the main drivers of proliferation, tumor progression, and metastasis.

The most common type of breast cancer ER positive breast cancer with the estrogen is one of the main drivers of proliferation tumor progression and metastasis.

Mitchell S. Steiner: Consequently, treatments that target the estrogen receptor are the mainstay of breast cancer therapy. Typically, women are treated with several lines of estrogen receptor-targeted agents like selective estrogen receptor modulators, SERMs, which include tamoxifen, non-steroidal aromatase inhibitors like letrozole or anastrozole, selective estrogen receptor degraders like provestrin, and these standards of care now include treatment with a Unfortunately, almost all of the women being treated will eventually develop resistance to an estrogen receptor-targeted endocrine and CDK4-6 inhibitor therapy.

Sequentially the treatments of target yesterday receptor of the mainstay of breast cancer therapy typically women are treated with several lines of estrogen receptor targeted agents like selective estrogen receptor modulator serums, which includes tamoxifen non steroidal aromatase inhibitors like that resolve of the anastrozole selective estrogen receptor degraders like.

For veteran and the standards of care now include treatment of the CDK for six inhibitors. Unfortunately, almost all of the women being treated with will eventually develop resistance to and estrogen receptor targeted endocrine and CDK for six inhibitor therapies and alternative treatment approaches with different mechanisms of action.

Mitchell S. Steiner: And alternative treatment approaches with different mechanisms of action will be required, including IV chemotherapy. Interestingly, like the estrogen receptor, the angiotensin receptor is found in over 85% of breast cancers. What is the endocrine receptor's function in breast cancer? 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 androgen receptor is a tumor suppressor in estrogen-receptor positive breast cancer.

And we'll be required including IV chemotherapy.

Interestingly.

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

Does the Andrew receptors function and breast cancer does it stimulator does it inhibit breast cancer growth and.

A recent publication in nature Medicine of an international study headed by Dr. Hickey of her team.

<unk> has provided scientific evidence establishing that the androgen receptor is a tumor suppressor and estrogen receptor positive breast cancer. This means and the Andrew receptor is activated by androgens. It's.

Mitchell S. Steiner: This means when the androgen receptor is activated by androgens, it strongly suppresses estrogen receptor positive breast cancer growth. This explains why, historically, when synthetic antigens were used to treat breast cancer, they demonstrated good activity. But unfortunately, the masculinizing side effects, the increase in hematocrit, and liver toxicity have prohibited their use as a viable treatment.

It is strongly suppresses estrogen receptive positive breast cancer growth. This explains why historically when synthetic antigens, we used to treat breast cancer. They demonstrated good activity, but unfortunately, the masculinizing side effects of increasing them adequate and liver toxicity has prohibited the their use as a viable treatment.

Contrast, and Nobu zone and oral first in class of 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, but prior to IV chemotherapy and.

Mitchell S. Steiner: Contrast, Inovasone, 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, HER2-negative, metastatic breast cancer prior to IV chemotherapy. NOVUSARM represents a new advanced... Inova Sarm 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 II clinical studies in advanced breast cancer involving more than 250 patients.

<unk> represents a new advancement and endocrine therapy for advanced breast cancer and decades.

And <unk> has extensive non clinical and clinical experience, having been evaluated and over 25 separate clinical studies involving more than 2001 hundred subjects, including five prior phase II clinical studies and advanced breast cancer involving more than 250 patients and addition to suppressing Andrew.

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

The receptor estrogen receptor of breast cancer cell proliferation of tumor growth and nobu sort of has other potential beneficial of clinical properties and preclinical studies and the <unk> has demonstrated the builds and heals critical and trabecular bone and therefore has the potential to treat osteoporosis and skeletal related events and cancer and <unk> has also been shown to reduce.

And as fat to build muscle and to improve physical function and clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer patients and Furthermore, because of its tissue selectivity and Novus arm has a favorable side effect profile with no vascularization, and so facial hair and acne, no increase and nomadic weight and no liver toxicity.

Mitchell S. Steiner: In clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer patients, and furthermore, because of its tissue selectivity, Inovasarm has a favorable side effect profile with no masculinization, that is, no facial hair and acne, no increase in hematocrit, and no liver toxicity. The science supporting the efficacy of InnovaScience... And the targeting of the antireceptor in ER-positive advanced breast cancer was also the subject of Nature Medicine Study Publishers Month by an independent group of breast cancer experts led by Dr. Hickey.

And the science supporting of the efficacy of of <unk> and the targeting of the Andrew receptor and Europe positive advanced breast cancer was also the subject of the nature Medicine study published this month by an independent group of breast cancer experts led by Dr. <unk>, Dr. Hickey and in their study they showed that using breast cancer tissue from patients who had resist.

Mitchell S. Steiner: And in their study, they showed that using breast cancer tissue from patients who had resistance to estrogen receptor-targeted and CDK4-6 inhibitor therapy, NovoSARM monotherapy exhibited significant anti-tumor activity. The combination of NovoSARM and a CDK4-6 inhibitor demonstrated even greater anti-tumor activity. Their data suggest that Inovasarm restores sensitivity of a CDK4-6 inhibitor-resistant breast cancer tissue to suppression by CDK4-6 inhibitors. Two positive Phase II studies involving 150 women with angina receptor-positive, estroreceptor-positive metastatic breast cancer were conducted.

<unk>, two estrogen receptor targeted and CDK for six inhibitor therapies and <unk> on monotherapy exhibited significant antitumor activity the.

Combination of the nobu assortment of CDK four six inhibitor demonstrated even greater anti tumor activity. The data suggests that and no storm and Novus arm restores sensitivity of the CDK <unk> inhibitor resistant breast cancer tissue to suppression by CDK for six inhibitor.

Two positive phase II studies involving 150 women with androgen receptor positive as true receptor positive metastatic breast cancer was conducted and we will focus on the second of these two studies the <unk> zero Zero 802 Phase III study, which is a two arm study evaluating <unk> nine milligrams and 80 milligrams of the Novus arm daily.

Mitchell S. Steiner: We will focus on the second of these two studies, the G200802 Phase II study, which is a two-arm study evaluating 9 milligrams and 18 milligrams of Inovasarm daily oral doses in 136 women with AR-positive, ER-positive, HER2-negative advanced breast cancer. The patients in this study were heavily pre-treated, having failed around three endocrine treatments, and 88% had received prior chemotherapy. The primary investigator for the study was Dr. Beth Obermoyer, founder and director of the Inflammatory Breast Cancer Program at Dana-Farber Cancer Institute in Boston, Massachusetts, and assistant professor of medicine at Harvard Medical School.

The world dosing and of 136 women with ER positive EUR of positive her two negative for advanced breast cancer.

The patients and the study were heavily pretreated, having failed around three endocrine treatments and 88% have received prior chemotherapy. The primary investigator for the study with Dr. Beth Oba Moyer founder and director of the inflammatory breast cancer program of Dana Farber Cancer Institute, and Boston, Massachusetts, and assistant Professor of.

Of medicine for the Harvard Medical School, the completed Phase II study results were recently presented as a spotlight presentation at the San Antonio breast cancer Symposium This past December.

Mitchell S. Steiner: The completed Phase II study results were recently presented as a spotlight presentation at the San Antonio Breast Cancer Symposium this past December by Professor Carlo Pomeri, Director of Translational Oncology and Medical Oncology at the University of Liverpool. The abstract 811 entitled, Advocacy and Safety of the Novus Arma, a Selective Angioreceptor Modulator to Target the Angioreceptor in Women with Advanced ER-positive, AR-positive Breast Cancer: final results from an international Phase II randomized study. According to this study, ANOVA-SARM therapy strongly establishes the relevance of targeting the antigen receptor with a selective antigen receptor activating agent as women with heavily pre-treated ester receptor-targeted resistant AR-positive, ER-positive metastatic breast cancer had favorable clinical benefit rates and objective and durable tumor responses. In fact, the presence of the antigen receptor was required as ANOVA-SARM's antitumor activity was not seen in AR-negative, ER-positive advanced breast cancer subjects.

Professor Carload per Mary Professor of translational oncology medical oncology at the University of Liverpool, the abstract 811, entitled efficacy and safety of and Nobis RMA. So like the vantage of receptor modulator to target the androgen receptor and women with advanced ER positive <unk> positive breast cancer final results for a minute.

International Phase II randomized study.

According to the study.

And the <unk> therapy strongly establishes the relevance of targeting the answer and receptor with a selective androgen receptor activating agent as women with heavily pretreated estrogen receptor targeted resistant and a positive Europe parts of the metastatic breast cancer has favorable clinical benefit rate and objective and dura.

<unk> tumor responses in fact, the president of the presence of the Andrew receptor was required as a notice of arms and to anti tumor activity would not seen and a negative ER positive advanced breast cancer subjects are staining status will be a critical inclusion criteria and the phase III clinical trial design to and.

Mitchell S. Steiner: AR staining status will be a critical inclusion criteria in the Phase III clinical trial design to enrich the study for a patient population who are most likely to benefit from ANOVA-SARM therapy. These subset analyses of AR staining and inovasarn antitumor activity from the Phase II clinical study will be presented at an upcoming scientific meeting. The novus arm appears safe and was well tolerated in the study without virilizing effects, an increase in hematocrit, or liver toxicity, and also quality of life measurements demonstrated overall improvement including mobility, anxiety, depression, and pain.

Which the study for a population of patient population, who are most likely to benefit from and now we're starting therapy. The subset analysis of AAR staining and of Novus arm of antitumor activity and the phase II clinical study will be presented as upcoming scientific meetings and Novus arm for your safe and was well tolerated and this day without realizing.

The FX increase and hematocrit of liver toxicity and also quality of life measurements demonstrated overall improvement, including mobility anxiety depression and pain. The nine milligram dose was selected for phase III is the nine milligram cohort had similar tumor responses with slightly better toxicity profile and the 18 milligram dose.

Mitchell S. Steiner: The 9-mg dose was selected for Phase 3, as the 9-mg cohort had similar tumor responses with a slightly better toxicity profile than the 18-mg dose cohort. We also performed a post-hoc subset analysis of the Phase II clinical data to understand whether Inovasarm had any anti-tumor efficacy in patients that had AR-positive, ER-positive metastatic breast cancer who were also resistant to both an esterine receptor targeting In the nine women who fit these criteria, Inovasarm treatment resulted in objective tumor responses of 33 percent.

Horton.

We also performed a post hoc subset analysis of the phase II clinical data to understand whether the Novus arm had any antitumor efficacy in patients that had a positive ER positive metastatic breast cancer, who will also resistant to both and estrogen receptor targeting agent and the CDK for.

<unk> six inhibitor.

And the nine women, who fit this criteria of these criteria.

And now this arm treatment resulted in objected tumor responses of 33%. We had two complete responses and one partial response and these nine women and clinical benefit rate of 24 weeks of 60% and of radiographic progression free survival of seven seven months of those small numbers one could conclude the novus arm has anti.

Mitchell S. Steiner: We had two complete responses and one partial response in these nine women, a clinical benefit rate at 24 weeks of 60 percent, and a radiographic progression pre-survival of 7.7 months. From those small numbers, one can conclude that Inovasarm has anti-tumor activity in women with AR-positive, ER-positive metastatic breast cancer that is resistant to esterine receptor targeting agents and CDK46 inhibitors. These subset analyses of CDK4-6 inhibitor resistance and anovus arm antitumor activity from the phase two clinical study will also be presented at an upcoming scientific meeting targeting the andro-receptor ER positive Metastatic Breast Cancer.

Tumor activity and women with ER positive ER positive metastatic breast cancer that has resisted the estrogen receptor targeting agents and CDK four and six inhibitors the.

And the subset analyses of CDK for six inhibitor resistance and the Novus arm antitumor activity from the Phase II clinical study will also be presented at upcoming scientific meetings by targeting of the annual receptor and ER positive metastatic breast cancer and Novus arm introduces a novel endocrine therapy to patients with breast cancer.

Mitchell S. Steiner: Inovasarm introduces a novel endocrine therapy to patients with breast cancer that have exhausted endocrine therapies targeting the estrogen receptor but prior to IV chemotherapy. In October of 2020, the company met with the FDA to discuss the NovoSARM Clinical Breast Cancer Program. The FDA agreed to the phase three registration clinical trial study to evaluate the efficacy and safety of NovoSARM 9 milligrams versus an active control, which can be either exomestate or tamoxifen, for the treatment of AR positive, ER positive, HER2 negative breast cancer in patients who have failed a non-steroidal aromatase inhibitor, provesterone, and a CDK4-6 inhibitor.

The have exhausted endocrine therapies targeting the estrogen receptor, but prior to IV chemotherapy.

And in October of 2020 of the company met with FDA to discuss the nobu saw on clinical breast cancer program. The FDA agreed to the phase III registration clinical trial. The study to evaluate the efficacy and safety of of Novus arm nine milligrams versus an active control, which can be either exemestane of tamoxifen for the treatment of.

On a positive ER positive her two negative breast cancer and patients who have failed the non steroidal aromatase inhibitor for vas trend and the CDK four and six inhibitor. The phase III study will be called the our test study and the primary endpoint will be radiographic progression free survival. It should be noted that we and key.

Mitchell S. Steiner: The Phase III study will be called the ARTES study, and the primary endpoint will be radiographic progression-free survival. It should be noted that we, and key breast cancer experts in the field, were intrigued by the preclinical study results reported in the Nature Medicine that showed the combination of Inovasorma, the CDK4-6 inhibitor, actually restored CDK4-6 inhibitor sensitivity in suppressing AR-positive, ER-positive metastatic breast cancer that was resistant to both an esterine receptor-targeted agent and a CDK4-6 inhibitor, which is, as you know, the target population in our plan phase three, our test clinical study.

Rest cancer experts and the field, we're intrigued by the preclinical study results reported in the nature medicine that showed the combination of the nobu starting with the CDK four six inhibitor actually restored CDK four six inhibitor of sensitivity and suppressing our positive view of positive metastatic breast cancer that was resistant the bow.

And estrogen receptor targeted agent and the CDK for six inhibitor, which is as you know the target population and our planned phase III our tests clinical study cause.

<unk> the.

The phase III are test trial is now designed to have three treatment arms and Novus arm alone and Novus arm in combination with the CDK <unk> inhibitor and an active control the either exemestane of tamoxifen. The trial sample size will remain approximately 240 women.

Mitchell S. Steiner: The Phase III R-Test trial is now designed to have three treatment arms: Anovus arm alone, Anovus arm in combination with a CDK4-6 inhibitor, and an active control to either exit metastain or tamoxifen. The trial sample size will remain approximately 240 women.

Pivotal phase III open label randomized active control or test study is anticipated to commence next quarter.

Mitchell S. Steiner: The Pivotal Phase III Open Label Randomized Active Control, our test study, is anticipated to commence next quarter. Next, I will update you on the Phase 2B clinical study evaluating Vero111 for the treatment of taxane-resistant metastatic triple negative breast cancer. Metastatic triple-negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% of all breast cancers.

Next I will update you on the phase <unk> clinical study evaluating bureau of 11 for the treatment of Taxane resistant metastatic triple negative breast cancer.

Metastatic triple negative breast cancer is an aggressive form of breast cancer, there's precedent and approximately 15% of all breast cancers. This form of breast cancer does not expressed the estrogen receptor the progesterone receptor over two or two and as resistance to endocrine therapies. The first line of treatment usually involves the IV taxane chemotherapy.

Mitchell S. Steiner: This form of breast cancer does not express the estrogen receptor, the progesterone receptor, or HER2, and is resistant to endocrine therapy. The first line of treatment usually involves IV taxane chemotherapy, and almost all women will eventually develop taxane resistance. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that 0111 significantly inhibits cancer proliferation, migration, metastasis, and evasion of triple negative breast cancer cells and tumors that have become resistant to paclitaxel, which is a taxane.

And almost all women will eventually develop taxane resistance preclinical studies and trip and human Triple negative breast cancer grown and animal models demonstrate that drew and 11 significantly inhibits cancer pillar for the proliferation migration metastasis and invasion of triple negative breast cancer cells and tumors that have become rizza.

And the Paclitaxel, which is a taxane.

Using the safety information from the phase <unk> and phase III <unk> hundred 11, prostate cancer clinical studies and the total of approximately 80 men and we plan to meet with FDA and the first half of calendar year 2021 to discuss the phase <unk> clinical <unk>.

Trial design for <unk>.

Mitchell S. Steiner: Using the safety information from the Phase 1b and Phase 2 Vero111 prostate cancer clinical studies and a total of approximately 80 men, we plan to meet with FDA in the first half of the calendar year 2021 to discuss the Phase 2b clinical trial design for possible accelerated approval for Vero111 versus an active control, TRODELV, for patients with taxane-resistant triple negative breast cancer, making the proposed trial. The Phase IIb clinical study is planned And, as I mentioned, this would represent a second major clinical oncology indication for VIR-111.

Hospital accelerated approval for <unk> 11 versus in the active control tordella the for patients with Taxane resistant and triple negative breast cancer, making the proposed trial and potential registration trial.

The phase <unk> clinical study is planned to commence and the second half of clinical year calendar year of 2021, and as I mentioned this would represent a second major clinical oncology indication severe one of 11.

We announced this past Monday positive results from the Phase II clinical trial evaluating Bureau of 111 for the treatment of hospitalized patients with COVID-19, who had high risk for acute respiratory distress syndrome. We were one of 11 in this setting is a novel once a day orally dose small molecule with both broad.

Mitchell S. Steiner: We announced this past Monday positive results from a Phase 2 clinical trial evaluating Veru-111 for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome. Viru-111 in this setting is a novel once-a-day, orally-dosed small molecule with both broad antiviral and anti-inflammatory activities, which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death.

The antiviral and anti inflammatory activities, which may serve a two pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects of <unk> and debt.

We conducted a double blind randomized placebo controlled phase II clinical trial evaluating daily oral once a day dosing of VB 111 to 18 milligrams versus placebo and approximately 40 hospitalized COVID-19 patients who had high risk of the acute respiratory distress syndrome. This trial was conducted and five sites across the United States.

Mitchell S. Steiner: We conducted a double-blind, randomized, placebo-controlled Phase 2 clinical trial evaluating daily oral once-a-day dosing of Vero111 18mg versus placebo in approximately 40 hospitalized COVID-19 patients who were at high risk for acute respiratory distress syndrome. The trial was conducted at five sites across the United States.

Patient received either <unk> of 11, 18 milligrams or placebo as well as standard of care for 21 days or until they were released from the hospital the.

Primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at day 29.

Here are the highlights of some of the clinical efficacy and safety results for the primary endpoint.

And a modified intent to treat M. ITT population Bureau of 111 treatment compared to placebo had a statistically significant and clinically meaningful improvement and the proportion of patients alive without respiratory failure of $94 four per cent and if youre. One of 11 treated group with the end of 18 and 70.

Mitchell S. Steiner: Patients received either Vero111 18mg or placebo as well as standard of care for 21 days or until they were released from the hospital. The primary efficacy endpoint was the proportion of patients that were alive without respiratory failure at day 29. Here are the highlights of some of the clinical efficacy and safety results.

Present, and the placebo group treated group and equals 20 of day 29.

Mitchell S. Steiner: In a modified intent-to-treat MITT population, Vero 1.11 treatment compared to placebo had a statistically significant and clinically meaningful improvement in a proportion of patients alive without respiratory failure of 94.4% in the Vero 1.11 treated group with an N of 18 and 70% in the placebo-treated group with an N of 20 at day 29. This represents an 81% relative reduction in treatment failures, a p-value of Here are some of the secondary...

And this represents an 81%.

And relative reduction and treatment failures of P value.

Of 0.0 of five.

Here are some of the secondary endpoints and the ITT population, we're one of the web and reduce the proportion of patients who died on the study from 30% and six out of 'twenty and the placebo group to five 3%, which is one of the 19 and the Bureau of one of 11 treated group. This is an 82% realm.

The of reduction of mortality and the peer 111 and treated group.

The value of their 0.0 for for the M. ITT population of <unk> hundred 11 showed a clinically meaningful reduction and the average days and the ICU.

Mitchell S. Steiner: In the ITT population, VERA-111 reduced the proportion of patients who died during the study from 30 percent, which is six out of 20, in the placebo group to 5.3 percent, which is one out of 19, in the VERA-111 treated group. This is an 82 percent relative reduction in mortality in the VERA-111 treated group. The P-value there is 0.044.

The 111 patients three days versus placebo and 955 days and that P values pointed out for <unk>.

<unk> hundred 11 had a clinically meaningful reduction in days on mechanical ventilation and from an average of five four days and the placebo group to one six days and the Bureau of 111 and treated group. During the study the standard of care included the treatment with either of them desert, Barry and or Dex.

Mitchell S. Steiner: In the MITT population, VERA-111 showed a clinically meaningful reduction in the average days in ICU. VERA-111 patients took three days versus placebo, 9.55 days, and that P-value is 0.04. Veru-111 had a clinically meaningful reduction in days on mechanical ventilation from an average of 5.4 days in the placebo group to 1.6 days in the Veru-111 treated group. During the study, the standard of care included treatment with either remdesivir and or dexamethasone under an emergency use authorization.

<unk> and methadone under an emergency use authorization.

A subgroup analysis of patients that receive standard of care was conducted and patients that received standard of care Bureau of 111 and treatment resulted in the clinically meaningful reduction and average days and the ICU Bureau on 11 was one for three days versus and the placebo 883 days P value 0.0 to four.

And the average days on mechanical ventilation and few of them on 11 zero days versus placebo six days of the P values of zero point of view of for $2 seven and the view of 111 group that also received standard of care no patient requiring mechanical ventilation on this small study for.

Mitchell S. Steiner: Subgroup analysis of patients that received standard of care was conducted. In patients that received standard of care, Veru 1.11 treatment resulted in a clinically meaningful reduction. In average days in the ICU, Veru 1.11 was 1.43 days versus 8.83 days for the placebo; p-value is 0.024. In average days on mechanical ventilation, Veru-111 had zero days versus placebo's six days. The p-value is 0.0427. In the Veru-111 group that also received standard of care, no patient required mechanical ventilation in this small study. Furthermore, Veru 111 was well-tolerated and had a very good safety profile.

The more virile, one web and was <unk> was well tolerated and had a very good safety profile.

Company has been granted and expedited the end of phase two meeting with FDA to discuss next steps, including a phase III clinical registration trial design. The view of 111, COVID-19 program. The company expects of this confirmatory study will have a similar trial design as it completed the phase II study to evaluate daily oral doses of <unk> hundred 11 <unk>.

And the placebo with the primary efficacy endpoint of the proportion of patients of the alive without respiratory failure of day 29, we expect the phase III clinical trial will be conducted and approximately 200 hospitalized patients who have COVID-19 and are at high risk for acute respiratory distress syndrome and <unk>.

Mitchell S. Steiner: The company has been granted an expedited end of Phase 2 meeting with FDA to discuss next steps, including a Phase 3 clinical registration trial design, the Vero111 COVID-19 program. The company expects that this confirmatory study will have a similar trial design as a completed Phase 2 study to evaluate daily oral doses of Vero111 versus placebo, with the primary efficacy endpoint being the proportion of patients that are alive without respiratory failure at day 29.

And he is expected to have sufficient clinical drug supply on hand to complete the phase III clinical study once agreed upon by FDA. The phase III is expected to commence in April of 2021 and is anticipated to be completed by the fourth quarter of calendar year 2021, we.

We will seek funding for the biomedical advanced research and development authority of the U S Department of health and human resource and human services BARDA and other agencies to try to fund the estimated amount of commercial drug to supply the needs of the U S population, assuming confirmatory positive result, and FDA approvals.

Mitchell S. Steiner: We expect a Phase 3 clinical trial will be conducted in approximately 200 hospitalized patients who have COVID-19 and are at high risk for acute respiratory distress syndrome. The company is expected to have sufficient clinical drug supply on hand to complete this Phase III clinical study. Once agreed upon by FDA, the Phase III trial is expected to commence in April of 2021 and is anticipated to be completed by the fourth quarter of calendar year 2021.

Due to the unprecedented the urgency of the global pandemic and the fact that COVID-19 continues to mutate into virus forums that may not be substantially mitigated by current vaccines of by any of the current duly approved antibody drugs. The other therapeutics were in need of and effective broad spectrum antiviral drugs for everyone.

11 has the potential to be both the broad spectrum antiviral agent and that anti inflammatory agent the strength of the study whether it was blinded placebo controlled randomized study that also allows the standard of care for both the treated and placebo groups and hospital patients and hybrids for <unk> based on the strength of these promising clinical results.

Mitchell S. Steiner: We will seek funding from the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, BARDA, and other agencies to try to fund the estimated amount of commercial drug to supply the needs of the U.S. population, assuming confirmatory positive results and FDA approval. Due to the unprecedented urgency of the global pandemic and the fact that COVID-19 continues to mutate into virus forms that may not be substantially mitigated by current vaccines or by any of the currently approved antibody drugs or other therapeutics, we are in need of an effective broad-spectrum antiviral drug.

The company continues to be duty bound during the persistent global pandemic to pursue this COVID-19 indication, even though it's not the primary focus of the company.

We are committed during this deadly pandemic to push ahead with view of 111 clinical developments of treatment against COVID-19, and we have the resources to conduct our planned phase III without impacting the cancer drugs clinical development.

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

Mitchell S. Steiner: 111 has the potential to be both that broad-spectrum antiviral agent and that anti-inflammatory agent. The strength of the study, whether it was a blinded, placebo-controlled, randomized study that also allowed standard of care for both the treated and placebo groups in hospital patients at high risk for ARDS, will be whether it was a blinded, placebo-controlled, randomized study that also allowed standard of care for both the treated and placebo Based on the strength of these promising clinical results, the company continues to be duty-bound during this persistent global pandemic to pursue this COVID-19 indication, even though we are committed during this deadly pandemic to push ahead with VERO111 clinical development as a treatment against COVID-19, and we have the resources to conduct our planned phase three without impacting the cancer drug's clinical development. I will now turn the call over to Michele Greco, Michele?

Thank you Dr. Steiner and Dr. Steiner indicated we started the fiscal year with a record breaking first quarter and December as the company sold previous business for $20 million $15 million and cash and $5 million of notes receivable due over an 18 month period.

The sale of payables resulted in an $18 4 million pre tax gain.

Overall net revenues were up 38% to a record $14 $6 million and $10 6 million and the prior year quarter due to the growth and our U S <unk> prescription business the.

The company recorded continued FC to sales growth and its prescription business with net revenue is up 50% to $9 1 million from $6 1 million.

And the prior year quarter net.

Net revenues for the public sector business also increased to $4 $7 million and four $4 million and the prior year quarter.

Michele Greco: Thank you, Dr. Steiner. As Dr. Steiner indicated, we started the fiscal year with a record-breaking first quarter. On December 8th, the company sold its pre-booth business for $20 million, $15 million in cash, and $5 million in notes receivable due over an 18-month period. The sale of Preboost resulted in an $18.4 million pre-tax gain. Overall, net revenues were up 38% to a record $14.6 million from $10.6 million in the prior year quarter due to the growth in our U.S. FC2 prescription business.

Net revenues for free boost through the sale date for $863000 compared to $153000 on the part of your quarter.

Overall gross profit was $10 8 million or 74% of net revenues compared to $7 $3 million for 69% of net revenues in the prior year quarter.

The increase in gross profit and gross margin is driven primarily by increased sales and our.

U S F C two prescription business.

Operating expenses for the quarter increased to $10 1 million compared to the prior year quarter of $9 $1 million.

Research and development costs of $5 7 million compared to $5 3 million and the prior year quarter.

Michele Greco: The company recorded continued FC2 sales growth in its prescription business, with net revenues up 50% to $9.1 million from $6.1 million in the prior year quarter. Net revenues for the public sector business also increased to $4.7 million from $4.4 million in the prior year quarter.

The operating income for the quarter was $19 2 million.

Compared to an operating loss of $1 $8 million and the prior year quarter and increase of $21 million the.

The increase was primarily due to the gain on the sale of <unk> of.

Michele Greco: Net revenues for pre-boost through the sale date were $863,000, compared to $153,000 in the prior year quarter. Overall, gross profit was $10.8 million, or 74% of net revenues, compared to $7.3 million, or 69% of net revenues in the prior year quarter. The increase in gross profit and gross margin is driven primarily by increased sales in our U.S. FC2 prescription business. Operating expenses for the quarter increased to $10.1 million compared to the prior year quarter of $9.1 million.

Of $18 $4 million.

Excluding the gain we had operating income of $780000 for the quarter.

Non operating expenses were $1 9 million compared to $1 6 million and the prior year quarter.

And primarily consisted of interest expense and change and the fair value of the derivative liabilities related to the synthetic royalty financing.

We entered the synthetic royalty financing during March of 2018.

For the quarter, we recorded a tax expense of $78000 compared to a tax benefit of $77000 and the prior year quarter.

The effective tax rate for the quarter was de Minimis due to reduction of the pre tax income related to warrants exercise and the utilization of net operating loss carryforwards and the U S.

Michele Greco: Research and development costs were $5.7 million compared to $5.3 million in the prior year quarter. The operating income for the quarter was $19.2 million compared to an operating loss of $1.8 million in the prior year quarter, an increase of $21 million. The increase is primarily due to the gain on the sale of Preboost of $18.4 million. Excluding the gain, we had operating income of $780,000 for the quarter.

The bottom line results for the quarter with net income of $17 $2 million.

For 23 cents per diluted common share compared to a net loss of $3 $3 million of five cents per diluted common share and the prior year quarter.

The company has net operating loss carryforwards for U S federal tax purposes of $41 $7 million with $13 $5 million expiring and years through 2038, and $28 $2 million, which can be carried forward indefinitely and the UK subsidiary has net operating loss carryforwards of $61 three.

Michele Greco: Non-operating expenses were $1.9 million compared to $1.6 million in the prior year quarter and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered into the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax expense of $78,000 compared to a tax benefit of $77,000 in the prior year quarter.

Which do not expire.

Now looking at the balance sheet.

As of December 31, 2020, our cash balance was $30 9 million and our accounts receivable.

Receivable balance was $4 $2 million.

Two of our sales people, we added $15 million and cash during December and had $5 million as notes receivable, which will be collected over the next 18 months of net working capital was $35 million of December 31, 2020, compared to $12 $3 million of September 30 of 2020 overall.

Michele Greco: The effective tax rate for the quarter is de minimis due to the reduction of the pre-tax income related to warrants exercise and the utilization of net operating loss carry forwards in the U.S. The bottom line result for the quarter was net income of $17.2 million, or $0.23 per diluted common share, compared to a net loss of $3.3 million, or $0.05 per diluted common share, in the prior year quarter. 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 can be carried forward indefinitely.

Overall, we're delighted to see the continued increases in sales and both the U S etsy to prescription business and the global public sector health sector of business. These revenue sources continue to be important sources of funds flow.

The best and our promising pharmaceutical clinical development program and 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 now I will turn the call back to Dr. Steiner.

Thank you Michelle we have enjoyed another record financial quarter, which has allowed us to significantly advance our clinical programs with robust performance of the sexual health business plus the prospects for additional revenue from tab fin and we believe that we're able to substantially invest and the continued clinical development of our prostate and breast cancer drug product candidates.

Michele Greco: And our U.K. subsidiary has net operating loss carry-forwards of $61.3 million, which do not expire. Now, looking at the balance sheet. As of December 31, 2020, our cash balance was $30.9 million, and our accounts receivable balance was $4.2 million. Through our sale of Preboost, we added $15 million in cash during December and have $5 million as notes receivable, which will be collected over the next 18 months. Our net working capital was $30.5 million at December 31, 2020, compared to $12.3 million at September 30, 2020.

And as well as beer 111, COVID-19 phase III study.

As a consequence, the company expects to have sufficient resources generated from our sexual health business and existing sources of cash to fund the clinical development of all of our currently planned registration clinical trials, we plan to continue to generate robust growing revenues and from the sexual health business, which is a standalone business is very.

<unk>, we're expecting another record year of fiscal year, 2021, and we could have options to monetize the business as we did with the pre boost business we.

Michele Greco: Overall, we're delighted to see the continued increases in sales in both the U.S. FC2 prescription business and the global public sector health sector business. These revenue sources continue to be important sources of funds to invest in our promising pharmaceutical clinical development programs. As we continue to transform our company into an oncology biopharmaceutical company with a focus on developing novel medicines for the Management of Prostate and Breast Cancer. Now I'll turn the call back to Dr. Steiner. Thank you, Michele.

We have successfully transformed the company into a late clinical stage oncology biopharmaceutical company supported by growing revenue cash generating sexual health business, we have a duty to expeditiously advance Bureau of one weapon and two a phase III clinical study and hospitalized patients with COVID-19 with high wish the Rds.

If we confirm these promising results from the <unk>.

Observed and the completed phase II clinical study, we expect to seek and.

The emergency use authorization for this indication.

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

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

Mitchell S. Steiner: We have enjoyed another record financial quarter, which has allowed us to significantly advance our clinical programs. With the robust performance of the sexual health business plus the prospects for additional revenue from TASFIN, we believe that we are able to substantially invest in the continued clinical development of our prostate and breast cancer drug product candidates, as well as VERU111 COVID-19 phase three studies. As a consequence, the company expects to have sufficient resources generated from our sexual health business and existing sources of cash to fund clinical development of all of our currently planned registration clinical trials.

I ask the question you May Press Star then one on your telephone keypad.

If you are using a speaker phone.

We ask that you. Please pickup your handset before pressing the keys to ensure the best sound quality.

To withdraw your question. Please press Star then two.

Please limit yourself to one question and one follow up.

If you have further questions you may reenter the question queue. Once again that is star then one to rejoin the question queue.

Mitchell S. Steiner: We plan to continue to generate robust growing revenues from the sexual health business, which as a standalone business is very valuable. We're expecting another record year in fiscal year 2021, and we could have options to monetize the business as we did with the pre-boost business.

We will pause momentarily to assemble our roster.

The first question comes from Brandon Folkes with Cantor Fitzgerald.

Please go ahead.

Alright, and thanks for taking my questions and congratulations on another good quarter and.

The image maybe just for.

Firstly coming back to COVID-19, and little bit.

Operator: We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company supported by a growing revenue, cash-generating sexual health business. We have a duty to expeditiously advance Veru111 into a Phase III clinical study in hospitalized patients with COVID-19 who are at high risk for ARDS. If we confirm these promising results observed in the completed Phase II clinical study, we expect to seek emergency use authorization for this indication. With that, I'll now open the call for questions. Ladies and gentlemen, at this time, we will begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad if you are using a speakerphone.

And you help us think how youre thinking of box, where we want to live in the division and the market and maybe I'll ask you to just try and frame.

Brian.

And even going into the phase II trial, but.

The market opportunity for group one of 11, the obviously.

Well I think early on on treatments vaccine so.

How do we how should we.

Thinking about debt market opportunity for one of 11 and Covid if we're successful there.

And then secondly.

We talked about potential for three 111.

The effect of again reach and strength do you think the FDA will ask you for and inclusion criteria to include some of these mutual strength.

In the phase III trial.

And then last and maybe I'll just ask.

And so on and apply them to you talk about having the financial flexibility to.

Brandon Richard Folkes: We ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star then 2. Please limit yourself to one question and one follow-up. If you have further questions, you may re-answer the questions. Once again, that is star then one to rejoin the question queue. We will pause momentarily to assemble our roster. The first question comes from Brandon Folkes with Cancer Fitzgerald. Please go ahead.

And all your programs.

And obviously you've got it can have a net you've got a lot going on.

Sort of.

Probably on par.

And it was about 600 patients with my math correct. This year.

The manufacturing scale up of cats, and she can just give us some color in terms of how much wiggle room.

Do you have and that statement. Thank you.

Thank you for the question and I'll answer the last question first and it's really more like if you added all of our programs together and they and they took place over the next two and a half years, you're probably closer to about 250 patients of 300 patients a year.

Mitchell S. Steiner: Hi, thanks for taking my questions and congratulations on another good quarter. So Mitch, maybe just firstly coming back to COVID-19 a little bit. Can you help us think about where we want to live in the tradition of the market, and maybe, obviously, just try to frame, obviously it's early, we've got to get through the Phase II trial, but... The market opportunity for Veru 1.11 there, obviously, we're all seeing early-line treatments and vaccines.

And so that's why if you do 100, thousands of patients and which is really the high and thats $30 million a year and.

We're generating we're generating more than that from our business.

So I think we've got a lot of wiggle room as it relates to funding so even though each of these trials have numbers its not all coming and this year. They start this year and then.

Mitchell S. Steiner: So how should we think about that market opportunity for 1.11 and COVID if we're successful there? And then, secondly, we talked about the potential for Veru 1.11 to be effective against mutant strains. Do you think the FDA will ask you for an inclusion criteria to include some of these mutant strains in the Phase 3 trial? And then lastly, you talk about having the financial flexibility to fund all your programs. Obviously, you've got a lot going on, probably running trials with about 600 patients this year. We've got the manufacturing scaler from Chapman.

On the move as quickly as we can to get it done.

And as it relates as it relates to your second question about whether the FDA is going to ask is do of mutant strained and then just when.

And remind everybody happier one of 11 works.

On the way via one of 11 works is the direct it disrupts the microtubule trafficking system within the South so think of it as of highway.

And the reason and it works both in inflamed and inflammation and and viral application is as follows the virus will bind to the outside of the cell and it gets internalize and it isn't just doesn't float around and it actually gets it gets pulled along the microtubules the highway into the nucleus.

Mitchell S. Steiner: So can you just give us some color in terms of how much wiggle room you have in that statement? Thank you. Thank you for the question. I'll answer the last question first.

It makes more virus and when it makes a whole bunch of new virus. It's got the payload has to be brought back out to the outside of the sales. So it can be dumped out so it can affect other sales and the way. It does that is again the highway and so the highway will actively transported the whether it's the virus coming in of the bunch of new virus is making its way out also the traffic.

Mitchell S. Steiner: It's really more like if you added all our programs together and they took place over the next two and a half years, you're probably close to about 250 patients or 300 patients a year. And so that's why, you know, if you do $100,000 a patient, which is really the high end, that's, you know, $30 million a year. And, you know, we're generating more than that from our business. So I think we've got a lot of wiggle room as it relates to funding.

<unk> system and.

And we cross link Alpha and beta tubular and that causes deep polymerization. It breaks down the highway so the as far as the highways concern and it doesn't care of of the Blue car of Redcar of sport of course.

<unk> of bus it doesn't matter. They all use the same highway system. So theres a lot of.

Mitchell S. Steiner: So even though each of these trials has numbers, they're not all coming in this year. They start this year, and then, you know, we're going to move as quickly as we can to get it done. As it relates to your second question about whether the FDA is going to ask us to do a mutant strain, let me just remind everybody how Vero111 works. The way Vero111 works is that it disrupts the microtubule trafficking system within the cell.

And so that's why we refer to as the broad spectrum anti virus is because it's not focused for example on and epitope onto on the on the.

Spike protein that you have to hit so it's much much broader than that.

But interestingly inflammation and follows the same way because of these vacuoles vacuoles in the sale of the contained cytokines interleukin and interferons.

They don't just flowed around her and vacuoles in a vacuum so on just float around the were actually moved around the south of the same highway system and so if you want to get something from inside the cell of outside of the dump. It out you have to go through the highway system. We disrupt that we showed that in preclinical studies literally every cytokines and looked at and monocytes and from the spleen.

Mitchell S. Steiner: So think of it as a highway. And the reason it works both in inflammation and in viral replication is as follows. The virus will bind to the outside of the cell, and it gets internalized. And it just doesn't float around.

We stopped the secretion.

Mitchell S. Steiner: It actually gets pulled along the microtubules, the highway, into the nucleus where it makes more viruses. And when it makes a whole bunch of new viruses, its got that payload has to be brought back out to the outside of the cell so it can be dumped out so it can infect other cells. And the way it does that is, again, the highway. So the highway will actively transport it, whether it's the virus coming in or a bunch of new viruses making their way out, all through the trafficking system. And, you know, we cross-link alpha and beta tubulin, and that causes depolymerization.

And of those cytokines. So that's why we believe we have preclinical evidence and now the phase two supports the.

Acting as an anti inflammatory and reacting as an antiviral sales.

And that standpoint, if the FDA asked us to look at additional strange.

I would argue by definition just always have to just look at the map of the United States and see we already have strange all over the place already so we're not going to have to actively look for COVID-19 strain mutant strain that's already here and so.

And what we'll do is we'll collect the information and we will know from the patients that come into the study whether the habit of not but it's not required at least at this point and again the FDA can do it.

And until we have our discussion with the FDA is one of the meeting has been granted at this point now I think I think I think we'll be fine no matter what they ask.

Mitchell S. Steiner: It breaks down the highway. So as far as the highway's concerned, it doesn't care if it's a blue car or a red car or, you know, a Porsche, a bus. It doesn't matter. They all use the same highway system.

As it relates to your first question, let's think about that for a moment and we started out everybody who said to US why would you want to do COVID-19 phase. Two this is going to be like all of the other viruses is going to come and go.

Mitchell S. Steiner: So there's a lot of—that's why we refer to this as a broad-spectrum antivirus because it's not focused, for example, on an epitope, on the spike protein that you have to hit. But interestingly, inflammation follows the same way because these vacuoles in the cell that contain cytokines, interleukins, and interferons don't just float around. They're in vacuoles, and the vacuoles don't just float around.

And if you remember my comment was maybe it'll come and go but at some point there'll be Covid 20, Covid 22, Covid 24, the spa.

Spanish flu was around the three of four years and and so I'm not quite sure of the gone, but I'll be honest with you I didn't know.

And if I would have told you that the number of the hospitalizations and the number of deaths and the number of cases exceed what we saw in March you would think I was crazy, but that's what happened and the death rate and one way of we have 85002 of 120000 hospitalizations.

Mitchell S. Steiner: They're actually moved around the cell through the same highway system. And so if you want to get something from inside the cell outside and dump it out, you have to go through the highway system. We disrupt that. We showed that in preclinical studies. And literally every cytokine we looked at in monocytes and from the spleen, we stopped the secretion of those cytokines.

And this country and.

And interestingly that has also changed meaning that it was anybody that had a low oxygen and antibody. The had COVID-19. They were brought into the hospital that's not happening anymore. What's happening now is you have to have a W. H O severity of a certain number of if you're on the oxygen or they already know who is going to get into trouble, who is not and so what's happening now is the <unk>.

Mitchell S. Steiner: So that's why we believe we have preclinical evidence and now phase two supports that, you know, acting as an anti-inflammatory and acting as an antiviral. So from that standpoint, if the FDA asks us to look at additional strains, I would argue, by definition, just all you have to do is look at the map of the United States and see that we already have strains all over the place already. So we're not going to have to actively look for a COVID-19 strain, a mutant strain. It's already here.

Hospitals are being patient population, that's being admitted to the hospital of being rich for the more severe patients. They have the risk factors that we're concerned about.

Nancy progression to Rds, which lead to the death of the multi organ failure. So with that said what I can tell you how we're positioning and this now is of Europe.

Mitchell S. Steiner: And so, you know, what we'll do is we'll collect the information, and we'll know from the patients that come into the study whether they have it or not, but it's not required, at least at this point. So until we have our discussion with the FDA, as you know, the meeting has been granted, at this point now, I think we'll be fine no matter what they ask.

If you just do the numbers and you look at 85 to 100000 hospitalizations and by the way.

And we'll go back and look the website.

On the Internet is filled with people of keeping track of the statistics and Youll see that its pretty much between 85, and 160000 hospitalizations of weak and its not really kind of I mean every time it goes down 20% and it's like yea, but it goes right back up and particularly after the Super Bowl and the Super Bowl parties and any of these things that take place and so the.

Mitchell S. Steiner: As it relates to your first question, let's think about that for a moment. When we started out, everybody said to us, "Why would you want to do COVID-19 phase two?" This is going to be like all the other viruses. It's going to come and go. And if you remember, my comment was maybe it'll come and go, but at some point, there'll be COVID-20, COVID-22, COVID-24. The Spanish flu was around for three or four years.

And this round it out and say you got about 100000 and even it goes to 85.

We put it in our numbers, 40% of those patients being at high risk and talking about market now 40% of those patients being high risk for <unk> and it doesn't take long before we realize we are going to need 37 million doses for a year, because we have to treat <unk>.

The 21 day and of course, so that's 21 doses per patient.

Mitchell S. Steiner: And so, you know, I'm not quite sure it'll be gone, but I'll be honest with you, I didn't know. And if I would have told you that the number of hospitalizations and the number of deaths and the number of cases would exceed what we saw in March, you would think I was crazy. But that's what happened.

The $7 million and that's at 40% what happened of the number goes maybe five to 40, well I would argue that even that goes in and 85000 patients of 40000 patients and those patients are going to be more likely to be 60 to 70 or 80% patients so they're going to be more likely to.

Go on to <unk>, so as the hospital system understands which patients are going to get and travel those patients of high risk of going to be exactly the patients that we believe our drug can work now and the other thing. We think is if we went into the lion's den and we were able to see this kind of activity on top of standard of care because remember with <unk>.

Mitchell S. Steiner: And the death rate went way up. We have 85,000 to 120,000 hospitalizations in this country. And interestingly, that has also changed, meaning that, you know, anybody that had low oxygen, anybody that had COVID, they were brought into the hospital. That's not happening anymore. What's happening now is you have to have a WHO severity of a certain number if you're on oxygen. They already know who's going to get into trouble and who's not.

Bo controlled double blinded, which means that the the.

No one knew who was on our drug and who was on placebo. So they got dexamethasone and they got convalescent plasma and they've got the.

Mitchell S. Steiner: And so what's happening now is the hospitals are being, the patient population that's being admitted into the hospitals is being rich for the more severe patients that have the risk factors that we're concerned about potentially progressing to ARDS, which leads to death and multi-organ failure. So with that said, what I can tell you how we're positioning this now is if you just do the numbers and you look at 85,000 to 100,000 hospitalizations, and by the way, go back and look. The website, the internet, is filled with people keeping track of these statistics.

When the desert view of the got whatever the kitchen sink they threw at them.

And still and that noise will be able to see these differences. So what would happen if we decide to go a little bit earlier.

And of course the issue. We had was the Bureau, and 11 was being developed with the prostate cancer product of breast cancer product, but what we've learned the 80 milligrams incredibly well tolerated and so we so we've answered that question and the additional study we do and the phase III will further answered the question for safety and if it turns out of the safety of.

Mitchell S. Steiner: And you'll see that it's pretty much between 85,000 and 160,000 hospitalizations a week. And it's not really kind of, I mean, every time it goes down 20%, it's like, yay, but it goes right back up, particularly after the Super Bowl and the Super Bowl parties and any of these things that take place.

And what it appears then I think as part of our plan.

We would try to go earlier, meaning maybe go after patients that have less severity and maybe go into patient can you imagine having and the oral antiviral broad spectrum agent that has this kind of activity now influenza.

Mitchell S. Steiner: And so just round it out and say, you got about 100,000 and even if it goes to 85, we put in our numbers, 40% of those patients being at high risk, I'm talking about the market now, 40% of those patients being at high risk for ARDS. And it doesn't take long before we realize we're going to need 37 million doses for a year because we have to treat, we're a 21-day course. So that's 21 doses per patient. 37 million.

Many of the other viruses used the same microtubule trafficking system. So the traffic and system is not only pertains to different mutants of Corona virus, but it also pertains to different virus types completely that cause disease, and the and I do think we're going to end up and the situation that we are going to coexist with COVID-19, we're not going to cure it.

Just like we coexist with influenza 60000 people still die from influenza the year. So I think the market's knock on a go away I don't know what the size is going to be but unlike last time, when everybody told as well the on waste your time, because it'll be gone and three months I would argue at this time I don't know the my Crystal ball is not clear and.

Mitchell S. Steiner: And that's at 40%. But what happens if the number goes from 85 to 40? Well, I would argue that even if it goes from 85,000 patients to 40,000 patients, those patients are going to be more likely to be 60, 70, or 80% patients that are going to be more likely to go on to ARDS. So as the hospital system understands which patients are going to get in trouble, those patients at high risk are going to be exactly the patients that we believe our drug can work for.

I think until until we get a handle on having effective.

Vaccines effective.

Antibody drugs and effective oral.

And oral therapeutics I think we have to keep pushing.

Great. Thank you very much.

Thank you.

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

Mitchell S. Steiner: Now, the other thing we think is if we went into the lion's den and we were able to see this kind of activity on top of standard of care. Because remember, it was placebo-controlled and double-blinded, which means that no one knew who was on our drug and who was on placebo. So they got dexamethasone, they got convalescent plasma, they got remdesivir, they got whatever the kitchen And still, in that noise, we were able to see these differences.

Okay.

Hi, Good morning, Thank you for taking my questions.

FC two sales could you tell us whether the record quarter was primarily driven by U S. Prescription sales or it is also driven by the FCC to international sales and do you expect the trend to continue thank you.

Yes.

Yeah.

Yeah, and then and Michelle would you like to answer that.

Sure and it was primarily driven by the.

As each of the U S prescription sales.

Mitchell S. Steiner: So what would happen if we decided to go a little bit earlier? And of course, the issue we had was Bureau 111 was being developed. It's a prostate cancer product, a breast cancer product. But what we've learned is the 18-milligram is incredibly well-tolerated. And so we've answered that question.

And they both sales increased 50%.

The $9 1 million from $6 1 million.

Last quarter.

Last year same quarter.

The global public sector sales also increased not at the same and not at the same.

The percentage, though.

Mitchell S. Steiner: And the additional study we do in phase three will further answer the question of safety. And if it turns out that safety is what it appears to be, then I think, as part of our plan, we would try to go earlier, meaning maybe go after patients that have less severity, maybe go into patients... Can you imagine having an oral antiviral, broad-spectrum agent that has this kind of activity? Now, influenza and many of the other viruses use the same microtubule trafficking system.

So we're seeing increases on both.

Got it Sir.

The question.

Could you comment on your expectation for capturing sales once it is commercially launched.

Yes, so on.

So let me just backtrack somebody just reminded me I could have usually a number of 100000 for COVID-19 and to make sure everybody on the shares 100 outs and the 85 to 100000 hospitalizations of week. Okay. So that's that's where that number comes from alright. So back to your question for <unk>.

Mitchell S. Steiner: So the trafficking system not only pertains to different mutants of coronavirus, but it also pertains to different virus types that cause disease. And I do think we're going to end up in a situation where we have to co-exist with COVID. We're not going to cure it, just like we co-exist with influenza. 60,000 people still die from it every year. So I think the market's not going away. I don't know what its size is going to be.

The way we would like.

With the FC two for example, we launch everything through the telemedicine Tele medicine, the really brand new animal right now in terms of the sales channel and the regions of the new animal is you end up with numbers that you just didn't expect so I'll give you. An example, typically when you launch of product to traditional specialty pharma sales force, which we do not have.

And we are not investing and the specialty sales the sales force.

Mitchell S. Steiner: But, you know, unlike last time when everybody told us, well, you know, don't waste your time because it'll be gone in three months, I would argue this time. My crystal ball is not clear. And I think until we get a handle on having effective vaccines, effective antibody drugs, and effective oral therapeutics, we have to keep pushing. Great, Thank you very much. The next question comes from Yi Chen of HC Wainwright. Please go ahead. Hi, good morning.

And you end up with some kind of uptake and the 300 prescriptions a month and that goes to maybe of valves. I mean, it has some number but its not tens of thousands hundreds of thousands and but the power of telemedicine is that you can reach hundreds of thousands and the short period of time, because it's all internet based and.

And it's all based on how many states that total medicine.

Company has access to it.

It's completely a brand new world in that regard and that's why we've been successful with FC too because we just broke away from the old World just had you know.

Yi Chen: Thank you for taking my questions. FC2 sales, could you tell us whether the record quarter was primarily driven by U.S. prescription sales, or it was also driven by FC2 international sales? And do you expect the trend to continue? Yes, Michele. Would you like to answer that?

And how many details of you're making two and obgyn office, the CV and sell the FC too that if you go back and look at those metrics and most of the single person can do is four to six day.

Details of day, and we of Internet It's unlimited.

Mitchell S. Steiner: Sure. It was primarily driven by FC2 US prescription sales. Those sales increased 50%, to 9.1 million from 6.1 million last quarter.

It really is an incredible blue ocean.

So our expectations right now is that we just don't know all we know is that we know that there are approximately 20 29 million prescriptions.

Mitchell S. Steiner: Last year, in the same quarter, global public sector sales also increased, and not by the same percentage. So we're seeing increases in both. Second question, could you comment on your expectation for Tadfin sales once it is commercially launched?

For.

Finasteride slash.

And when you get into the Seattle is but if you look at for example, tamps lotion and the finasteride and you start looking at BPH prescriptions.

Mitchell S. Steiner: Somebody just reminded me I kept using the number 100,000 for COVID-19 to make sure everybody understands 100,000, 85 to 100,000 hospitalizations a week. Okay, so that's where that number comes from. All right, so back to your question for Tad Finn.

It's the only between 23 and 29 million prescriptions, a year and it's a big number.

And as you know BPH is number one and prevalent.

And I can tell you is that urologists disease at men over 50 will have.

Mitchell S. Steiner: You know, with FC2, for example, we launched everything through telemedicine. Telemedicine is a really brand new animal right now in terms of a sales channel. And the reason it's a new animal is that you end up with numbers that you just didn't expect. So I'll give you an example.

So right now we.

We just don't know I wish I can give you a number of except I think we're looking at it now is.

We're going to because of the brand new world.

We have not given guidance yet in terms of what we think the actual numbers will be.

What I will tell you is it feels big.

Mitchell S. Steiner: Typically, when you launch a product through traditional specialty pharmaceuticals, which we do not have, and we are not investing in a specialty sales force, you end up with, you know, some kind of uptake, you know, 300 prescriptions a month, and it goes to maybe a thousand. I mean, it has some numbers, but it's not tens of thousands, it's not hundreds of thousands. But the power of telemedicine is that you can reach hundreds of thousands in a short period of time because it's all internet-based, and it's all based on how many states that the telemedicine company has access to.

But let us test it.

Got it last question of what do you expect to report top line results from the phase II trial of the ruble and level of new prostate cancer and one of the results come out.

And that have any impact on.

The phase III trial. Thank you.

You know here, we are heading heading into year two.

With the phase <unk>, So I don't know and maybe I mean.

And if I had my druthers would be another year and of half of them now, but I'm just joking, but it's true and so I think of what we're going to do is just like we're doing with the phase. One b is we're going to reported as long as patients on study.

And I can tell you the day mirroring each other quite well the phase <unk> and the phase II of mirroring each other meaning that we're seeing of PSA declines PSA responses partial responses complete.

Mitchell S. Steiner: It's completely a brand new world in that regard, and that's why we've been successful with FC2 because we just broke away from the old, well, just how many details are you making to an OBGYN office to see if you can sell FC2? If you go back and look at those metrics, the most a single person can do is four to six details a day. With the internet, it's unlimited. It really is an incredible blue ocean.

And.

In the phase II as of the complete response are you seeing tumor activity and and were focus focus focus on safety and making sure we have the right recommended.

And the dose of 63, it looks like it's playing out very nicely and.

And so that's the kind of information you want the new phase one being the phase II. So the answer is net theres nothing and the one view of the phase II at this point because even when the combined the information Thats so similar.

Mitchell S. Steiner: So our expectations right now are that we just don't know. All we know is that there are approximately 20, 29 million prescriptions for finasteride slash (I wouldn't even get into Cialis), but if you look at, for example, Tamsulosin and finasteride and you start looking at BPH prescriptions, it's somewhere between 23 and 29 million prescriptions a year. And it's a big number. And as you know, BPH is the number one prevalent disease that men over 50 will have.

And that will change the course of how we're thinking about the phase III. So that's why we feel comfortable starting the phase III. We do not believe we're going to learn any more information about dose any more information about the efficacy. We expect net does any more information on the safety and so if that's the case then.

The only thing I'll add to that comment is that the patients that we used and the phase <unk> and the phase II of sicker patients, meaning that and the phase one b. They were allowed to have chemo.

Mitchell S. Steiner: So right now, we just don't know. I wish I could give you a number, except I think the way we're looking at it now is because it's a brand new world; we have not given guidance yet in terms of what we think the actual numbers will be. What I will tell you is that it feels big, but we have to test it.

44% and the phase <unk> also got more than one targeted.

And we set the targeted agent that's another phase III design and then the phase II. The same thing we have half the patients had more than one antigen receptor target of agent and some cases at three of four that's not the patient population and the phase III phase III of patients that failed.

Mitchell S. Steiner: Got it. Last question. When do you expect to report top-line results from the Phase 2 trial of Veru11 in prostate cancer? And when will those results come out? Will that have any impact on the Phase 3 trial? You know, here we are heading into year two with phase 1B. So I don't know. Maybe, I mean, if I had my druthers, it would be another year and a half from now, right? But I'm just joking, but it's true.

Androgen deprivation therapy, and they failed one of the androgen receptor targeted agent. So we think that that's going to have if anything the results of the better not worse and so we're pretty happy with the results that we see now so we.

We're thinking we're thinking that's going to give us some upside so I think the answer to your question is that we will continue to update.

And with the different scientific meetings, just like we're going to be doing this week and and Youll see more data on the phase one b. The right now we're just waiting on those three patients that have just.

Mitchell S. Steiner: And so I think what we're going to do is, just like we did with phase 1B, report as long as patients are on study. But I can tell you that they're mirroring each other quite well.

Taking this drug at home every day every day.

Chronic it's feasible and it's well tolerated and that's critical because if you look at some of these oral taxane.

Mitchell S. Steiner: The phase 1B and phase 2 are mirroring each other, meaning that we're seeing PSA declines, PSA responses, partial responses, and phase 2 is a complete response. So you're seeing tumor activity. And we're focused, focused, focused on safety, making sure we have the right recommended dose. 63 looks like it's playing out very nicely.

They still have some of the same side effects as the IV taxane and and.

Urologists, if theyre going to give this drug and that can be interested and dealing with neutropenia, and sepsis, and giving neulasta and GM CSF support and.

Mitchell S. Steiner: And so that's the kind of information you want from your phase 1B and phase 2. So the answer is there's nothing in phase 1B or phase 2 at this point because even when we combine the information, it's so similar. That will change the course of how we're thinking about Phase 3. So that's why we feel comfortable starting Phase 3. We do not believe we're going to learn any more information about the dose, any more information about the efficacy we expect from that dose, or any more information on safety.

And now and we just don't I mean, we won't be able to give a patient of pill and managed to manage the side effects bye bye.

By telephone and not be not having to manage the side effects as a medical oncologist, because thats, where that sort of the specialty is so we think the tremendous value with.

And one of 11 brings and prostate cancer and hopefully the breast cancer is that.

It's the fact of the safety will allow.

Patients to take this at home and not be worried about the whitesell dropping to appoint and have to be put into the ICU.

Mitchell S. Steiner: And so if that's the case, then, you know, the only thing I'd add to that comment is that the patients that we used in the Phase 1 study are sicker patients, meaning that in phase 1b, they were allowed to have chemo, and 44% of those in phase 1b also got more than one targeted androgen receptor targeted agent. That's not a phase 3 design.

Got it thank you.

Thank you.

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

Congratulations on the progress and thanks for taking my questions.

Mitchell S. Steiner: And in phase 2, the same thing. We have, you know, half the patients had more than one androgen receptor targeted agent. In some cases, they had three or four.

First with regard to COVID-19.

And what kind of impact.

Mitchell S. Steiner: That's not the patient population in phase 3. Phase 3 are patients that failed androgen deprepation therapy, and they failed one androgen receptor targeted agent. So we think that that's going to have, you know, if anything, the results will be better, not worse. And so we're pretty happy with the results that we see now. So, you know, we think, you know, we think that's going to give us some upside. So I think the answer to your question is that we will continue to update you with the different scientific meetings, just like we're going to be doing this week, and you'll see more data on phase 1b. But right now, we're just waiting on those three patients that are just, you know, you know, taking this drug at home every day, every day. You know, chronic, it's feasible, it's well tolerated.

Guys seeing and thousands of the.

Day as these patients are staying in the hospital of you're seeing any impact the hum.

And with regard to the oxy to.

And how much in broad do you guys think you have made in terms of the U S prescription market.

And in terms of the growth model genes, where do you guys see this going from where you are right now.

Okay.

Alright, so some of that and go backwards right. So the answer the question how many how much inroads so.

We had about I don't know 300 and <unk>.

<unk> thousand and prescriptions of this past year and.

And we just mentioned we have 116000 prescriptions.

And there was about 40 million women that could take this product.

So were just barely scratching the surface of huge huge of blue Ocean for us and the and all you have to look on the Internet and see how many new sexual health telemedicine groups of opening up.

Mitchell S. Steiner: And that's critical because if you look at some of these oil tax hames, they still have some of the same side effects as the IV taxings, and, you know, urologists, if they're going to give this drug, they're not going to be interested in dealing with neutropenia and sepsis and giving Nudelasta and GM-CSF support, and, you know, and no, we I mean, we want to be able to give a patient a pill and manage the side effects by telephone and not be, you know, not having to manage the side effects as a medical oncologist would because that's what their specialty is.

And and so this telemedicine, there's tremendous growth and telemedicine right now and the other way to get to that Blue Ocean is to take advantage of the internet the <unk>.

Fact of the Affordable Care Act covers the prescription the.

Fact that women and no longer I mean, the non colleges anymore of the sitting home using the telephone to the order what they need the order, including prescriptions and and.

And for sexual health, So we think.

And it's still a blue Ocean. We just don't know we think we think we can't even tell you how big it can be because of the fact and the other interesting point is that the male condom business compared to the female condom business, we're still less than 1% 2%.

And with the me too movement and empowerment and and this is the only FCT of these the only a burst of birth control and the STI sexually transmitted disease protection dual protection.

Mitchell S. Steiner: So we think the tremendous value that Vero111 brings to prostate cancer and, hopefully, to breast cancer is that, you know, it's the fact that safety will allow patients to take this at home and not be worried about their white cells dropping to a point where they'd have to be put into the ICU.

And that of women can initiate and control I think I think.

The real there's real opportunity on the gross margin is dependent on whether we sell ex U S and U S.

We have a nice margin and in the U S and.

Kumar Raja: Thank you. The next question comes from Kumar Raja of Brookline Capital Markets. Please go ahead.

And we don't spend money on marketing and selling very minimal.

It's all done by the telemedicine groups. So so we expect the as you saw this quarter, we expect to continue to see our gross margins for this product go up as the mix of sales continue to be.

Mitchell S. Steiner: Congratulations on the progress and thanks for taking my questions. First, with regard to COVID-19, what kind of impact are you guys seeing in terms of the days these patients are staying in the hospital? Are you seeing any impact there?

Growing and dominated.

Mitchell S. Steiner: And with regard to FC2... How much inroads do you guys think you have made in terms of the U.S. prescription market? And in terms of gross margins, where do you guys see this going from where you are right now? All right, so I'm going to go backwards, all right? So to answer the question, how much inroads?

Dominated in terms of the numbers.

And U S versus ex U S and so we're looking forward to that and as it relates to.

The COVID-19 question, what's the impact on hospitalizations.

The <unk>.

Mitchell S. Steiner: So we had about, I don't know, 350,000 prescriptions this past year. And we just mentioned we have 116,000 prescriptions. There are about 40 million women that could take this product. So we're just barely scratching the surface. It's a huge, huge blue ocean for us.

And I know, we've looked at top line data and I have not seen the hospitalizations.

So the patients of our this is Gerry one of the patients and our study are very sick and obviously, the hospitalization and duration of hospitalization is highly variable.

But when you look at the days on study and your days of dosing specifically the gauge of dosing, we do see and this is capped at 21 days. The placebo group had about a little over 11 average 11 days of dosing and in the treated group of it was little under nine days of dosing. So we are seeing and that.

Mitchell S. Steiner: And all you have to do is look on the internet and see how many new sexual health telemedicine groups are opening up. And so there's telemedicine; there's tremendous growth in telemedicine right now. And the only way to get to that blue ocean is to take advantage of the internet, the fact that the Affordable Care Act covers prescription drugs, the fact that women are no longer, I mean, they're not in college anymore, they're sitting home using their telephone to order what they need to order, including prescriptions and for sexual health, so we think. It's still a blue ocean,

It would correlate the hospitalization.

<unk>.

But the top line data, that's what we got and having the top line data. So I do expect to see some reduction, but do the ability of I'm not sure exactly how strong it will be.

Okay, and maybe finally of question with regard to where the one Lebanon and Obama and interaction with the email and where do these kinds of things.

Mitchell S. Steiner: We just don't know. We can't even tell you how big it can be because of that fact. The other interesting point is that the male condom business, compared to the female condom business, we're still less than 1%, 2%. With the Me Too movement and empowerment, and this is the only birth control and STD, sexually transmitted disease, protection, dual protection, that a woman can initiate and control, I think there's a real opportunity. The gross margin is dependent on whether we sell ex-U.S. or in-U.S. We have a nice margin in the U.S., and we don't spend money on marketing and selling; it's very minimal.

The human and EMA for.

<unk> 11, so I'll be honest and we've been so focused on the U S right now.

And that we have not initiated anything with the EMA at this point I think what we need to do is get on.

As I mentioned and my comments, we have been granted a.

And expedited meeting with the FDA, we already have that on the books, we're getting ready for that.

Already said on meeting package that we.

We've moved along and we're looking forward to understanding the phase III design and once we get that up and going.

And then we can probably reach out to the EMA, but I'll be honest with you and I think I think if we can.

And get the FTA under control and while that's going on and deal with CMA.

Mitchell S. Steiner: That's all done by the telemedicine groups, so we expect, as you saw this quarter, we expect to continue to see our gross margins for this product go up as the mix of sales continues to be growing and dominated in terms of the numbers in the U.S. versus ex-U.S., and so we're looking forward to that. As it relates to... The COVID-19 question: what's the impact on hospitalizations? I know we've looked at top-line data, but I have not seen the hospitalizations.

And then that will take care of 80% of the regulatory authorities across the world that would take one or the other.

So that's where we are.

Okay, great. Thank you.

The next question comes from Leland <unk> of.

Oppenheimer. Please go ahead.

Hey, good morning, Thanks for taking the questions.

Once all the question of do you definitely the <unk>.

And the.

Mitchell S. Steiner: Yeah, so the patients in our, this is Gary Barnett, the patients in our study are very sick, and obviously, hospitalization, duration of hospitalization is highly variable. But when you look at the days on study, meaning days of dosing, specifically the days of dosing, we do see, and this is capped at 21 days. The placebo group had about a little over 11, average 11 days of dosing.

One was in prostate cancer study.

The neuro Tox was all managed by the introduction of consultation and able to continue with dose reduction.

And Theres, new indications with the newer clubs.

It was slight tingling and the fingers that went away with time and still stay on dose. So it did not require of dose reduction and the went away on on the high dose and and and.

Gary Barnett: And in the treated group, it was a little under nine days of dosing. So we are seeing, and that would correlate to hospitalization. But the top-line data, that's what we have in the top-line data. So I do expect to see some reduction, but due to the variability, I'm not sure exactly how strong it'll be. Okay, maybe finally, a question with regard to Veru 111 and InnoBasm and interaction with the EMA. Where do we stand there? Thanks. 111

Just day, one grade one grade one sorry grade one grade.

Okay.

And then and the question and then in terms of positioning of the with the oral Taxane zone.

Thanks, James and IV chemo.

There is obviously the day.

The oral formulation and you've got the better toxicity profile and then move on.

Some of them and for all wells.

And I'm kind of of all of our efficacy and I wanted to.

<unk>.

Mitchell S. Steiner: So I'll be honest with you, we've been so focused on the U.S. right now that we have not initiated anything with the EMA at this point. I think what we need to do is get our, you know, as I mentioned in my comments, we've been granted an, you know, an expedited meeting with the FDA. We already have that on the books.

And I was one of the use of more effective ways and upfront and then if one of 11 isn't as effective.

Even though it may not be head to head on but if it doesn't appear so take those maybe would reserve that for.

Lee or even with the earlier and chemo agents have more tolerability issues, what how would you kind of answer.

Mitchell S. Steiner: We're getting ready for that. We already sent our meeting package. So we've moved along, and we're looking forward to understanding the phase three design. And once we get that up and running, you know, then we can probably reach out to the EMA. But I'll be honest with you; I think if we can get the FDA under control and, while that's going on, deal with EMA, then that will take care of, you know, 80% of the regulatory authorities across the world that would take one or the other. That's who we are.

All of that to somebody who may be more focused on clinical.

And hard nosed efficacy comparison.

Yeah.

No.

So the way I would answer that is as you know cancer has become and marathon.

So the issue there is is is no longer.

And with the hardest thing you can hit them with and lose here and.

And just be thankful, we picked up a couple of days and as the surge and we used to do that rather everything was radical so I think the approach to cancer care. Now is you start with things that have the right benefit risk profile and you start early and Youll get and you're going to choose something that has good efficacy and good safety and then you're going to work.

Mitchell S. Steiner: Great, thank you. The next question comes from Leland Gershell of Oppenheimer. Hey, good morning.

Leland James Gershell: I'm just kind of checking the questions. Um, I wanted to ask the question of the patient in the, um, 1-11 prostate cancer study who, uh, had the neurotox. Was that managed by dose reduction? Was that patient able to continue with dose reduction? What was the disposition of the patient who had the neurotox? It was a slight tingling in the fingers that went away with time.

And to the.

The compounds of the agents that have.

Efficacy and worst safety to the point you get to compounds that have some efficacy and maybe very very bad safety, So and this situation and the way we see it and the way we're positioning as the pre chemo agent is we just do not require pre medication.

Mitchell S. Steiner: It still stayed on the dose, so it did not require a dose reduction, and it went away on the high dose. And it was just day one. Grade one. Grade one, sorry grade one. Great one. I got it. Okay. And then the question, you know, in terms of positioning of this, you know, with the oral taxanes and the IV taxanes and IV chemo, you know, there's obviously the oral formulation, you've got the better toxicity profile.

And with.

Prednisone and with the.

And the Histamines and without taking up a chair.

The patient and not having to get the last of the GM CSF support for the right for.

The neutropenia and Youre not having demands for the toxicities with all kinds of agents.

From the vomiting on and so.

And so and the efficacy.

The efficacy again, its not head to head, but if you look at the efficacy of <unk> and compare to some of the some of the IV Taxane and.

Mitchell S. Steiner: And then you have some who may say, well, you know, it's, I'm kind of all about efficacy and I want to see this, you know, I want to use the more effective agent up front and then if 111 isn't as effective, you know, even though it may not be head-to-head, but if it doesn't appear as effective, maybe you would reserve that for, later, even if the earlier chemo agents have more tolerability issues, how would you kind of answer, you know, that to somebody who may be, you know, more focused on kind of a hard-nosed efficacy comparison? Yeah, so the way I would answer that is that, as you know, cancer has become a marathon.

And the signals they saw in the phase one b phase one phase <unk> setting.

Comparable.

For sure and.

Without the safety, so I would say less of the way that the way to think of it as we want it and we want to be and the pre chemo space and.

And the best way to be and the pre chemo space is to have safety, that's more like it and antigen receptor targeting agent then having safety. This is more like a taxane.

Or worse and when that worse I mean, the agents of all wonderful agents will give me one of the worst mean, the toxicity could be worse.

Got it alright, thanks, great progress.

Thank you.

The next question comes from Peter Mcmullin of Peter Mcmullin CSA consulting. Please go ahead.

Mitchell S. Steiner: So the issue there is we no longer hit them with the hardest thing you can hit them with and lose air and, you know, and just be thankful we picked up a couple of days. And as a surgeon, we used to do that. Everything was radical.

Good morning, Doctor Merch and congratulations to you and the team for tremendous progress.

Quick two questions on the F shoot to you do have an exclusive and the US there are competitors out there whats is there any rumblings that somebody else might try to get FDA approval.

Mitchell S. Steiner: So I think the approach to cancer care now is you start with things that have the right benefit-risk profile, and you start early, and you're going to choose something that has good efficacy and good safety, and then you're going to work your way to the compounds or the agents that have, you know, efficacy and worse safety to a point where you get to compounds that have some efficacy and maybe very, very bad safety. So in this situation, the way we see it and the way we position ourselves as a prechemo agent is that we just do not require premedication with prednisone and antihistamines. We're not taking up a chair.

And just the second part would be on the international sales with everybody being at home.

And is there any tenders coming up of of significance that you could comment.

Yeah, So I'm and I'm Gonna have Michel comment on the international sales because he's closer to that and then as it relates to.

The U S.

And actually hearing no rumblings of this point.

In terms of others.

As you know.

Because we because of the because of where the.

Mitchell S. Steiner: The patient doesn't have to get Neulasta for GMCSF support for neutropenia, and you don't have to manage the toxicities with, you know, all kinds of agents, you know, from vomiting on. And so, you know, and the efficacy, you know, the efficacy, again, it's not head-to-head, but if you look at the efficacy of Vero111 compared to some of the IV taxanes, and the signals they saw in the Phase I, and Phase Ib setting, were comparable for sure without the safety.

Leader and the U S and this is a lot of brand loyalty and so we're kind of Coca Cola and why would anybody on RSC.

And with that said.

There is no there's no there's no rumblings of that I know of at this point and we've been watching it very closely.

And so we're still we're still the market leader and the U S. Ex U S. Michelle do you want to comment on the tenders and whether its look alike.

Sure.

Yeah.

We announced that we won the Brazil tender. So we're working on supplying that this year, Peter so that will be the.

Mitchell S. Steiner: So I would say, you know, the way to think of it is that, you know, we want to be in the prechemo space, and the best way to be in the prechemo space is to have safety that's more like, you know, an antigen receptor targeting agent than having safety that's more like a taxane or worse. Not worse meaning the agents are all wonderful agents, don't get me wrong, but worse meaning the toxicity could be worse.

<unk> this year and into next fiscal year, and then the South Africa.

The tender that we had announced that we won the government has extended the timeline for that so instead of delivering product over three years, it's going to be over a five year timeframe and.

Mitchell S. Steiner: Okay, thanks. Great progress. Thank you. The next question comes from Peter McMullen of Peter McMullen CFA Consulting. Please go ahead. Good morning, Dr. Mitch, and congratulations to you and the team for tremendous progress. Quick two questions on FC2.

And and we're just waiting to see.

What the ordering is gonna be and South Africa, So that just preserves us and those two main markets.

But nothing outside of that at this point and time.

The theyre not big tenders, and the and the other countries.

Peter McMullen: You do have an exclusive in the U.S. There are competitors out there, but are there any rumblings that somebody else might try to get FDA approval?

And then mainly through you and FPA USAA D and now also true D. K T. Another distributor.

Mitchell S. Steiner: And just the second part would be on international sales with everybody being at home. Are there any tenders coming up of significance that you could comment on? Yeah, so I'm going to have Michele comment on international sales because she's closer to that. And then as it relates to the US, we're actually hearing no rumblings at this point in terms of others. As you know, because we're the market leader in the US, there's a lot of brand loyalty, and so we're kind of like Coca-Cola, and why would anybody want RC?

Okay. Thank you.

Thank you Peter.

And the last questioner today will be from Brian It will be Brandon Folkes for the follow up on cancer Fitzgerald. Please go ahead.

Yes.

Hey, Matt Sorry, just one thing I wanted to follow up and it's a little bit kind of a segue from the last question can you just talk about the barriers to entry on the FCT.

Yes.

Yeah, I'd be happy too so the barriers to entry is one is we still have patent coverage and the U S. Although it is just for a couple of more years or so and but we do second even though it's a class two device now instead of the class III. It still requires special controls, which means the pregnancy.

Michele Greco: But with that said, there's no rumblings that I know of at this point, and we've been watching it very closely. And so we're still the market leader in the US. Actually, I'm going to ask Michele, do you want to comment on the tenders and what it's looking like? Sure. You know, we announced that we won the Brazil tender, so we're working on supplying that this year, Peter, so that will be supplied this year and into the next fiscal year.

Studies Tolerability studies.

Studies proving that you can prevent the STS stis.

And so there's a whole host of and.

And you know the Immunogenicity studies and all of the stuff and so.

Michele Greco: And then South Africa, the tender that we had announced that we won, the government has extended the timeline for that, so instead of delivering product over three years, it's going to be over a five-year timeframe, and we're just waiting to see, you know, what the ordering is going to be in South Africa. So that just preserves us in those two main markets. But nothing outside of that at this point in time.

And so there's probably in the order of about.

On a $6 million to $12 million worth of staff and interesting and take you three years to six years to do and so the so that's a barrier to entry. It took us I don't know 18 months to build the infrastructure to sell by prescription and the U S and thats not trivial.

So that has to be done and you have to get all of the contracts with the big distributors to do that.

Peter McMullen: They're not big tenders in other countries, you know; we supply them mainly through UNFPA, USAID, and now also through DKT, another distributor. Okay, thank you. Thank you, Peter. And the last questioner today will be Brandon Folkes with a follow-up on Cancer Fitzgerald.

We also have brand loyalty, which is also.

<unk>.

A barrier to entry and people want the FCT they know the FCT.

By way of the comparison the ex U S. There is a ton of comp.

The competitors.

Brandon Richard Folkes: Please go ahead. Hey Mitch, sorry, just one thing I wanted to follow up on, and it's a little bit of a segue from the last question. Can you just talk about the barriers to entry into the SE2 business? Yeah.

They've been there for many years, but we've always maintained about 90% to 95% market share and that's the wild wild west outside the U S and and that's because again brand loyalty people like it and the other thing we have the.

I'd be happy to. So the barriers to entry are, one, we still have patent coverage in the U.S., although it's just for a couple more years or so, but we do. Second, even though it's a Class II device now instead of a Class III, it still requires special controls, which means pregnancy studies, tolerability studies, studies proving that you can prevent STIs.

And that's the only feature of that the FCC has its nitrile and so the nitrile and strong growth and nitrile is also hypoallergenic and so you're not dealing with the latex allergies that you would see which can occur at 10% of patients, particularly with and dwelling.

So there's a whole host of immunogenicity studies and all this stuff. And so it's probably in the order of about $6 to $12 million worth of stuff, and it's going to take you three to six years to do. And so that's a barrier to entry. It took us, I don't know, 18 months to build the infrastructure to sell by prescription in the U.S., so that's not trivial.

Internal condom as opposed to next total condom and then you can argue will just 10%, 90% and spine no you just don't know which 10% of it is.

So that's the problem. So so there are a lot of barriers to entry and and we've had the product now and since we took the since since the female health Company acquired Aspen Park, and and you can see the sales of gone up and the and there's a lot of room to grow the asset and the OTC markets and.

So that has to be done, and you have to get all the contracts with the big distributors to do that. We're working very hard also in the U.S. public sector, the ex-U.S. public sector. So the asset is an incredibly viable asset that's growing.

And we're working very very hard also on the U S public sector.

Ex U S publicly some of the assets.

Credit with viable assets Thats growing.

Thanks, that's very helpful. 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 all of you on our progress at our next Investors Call. Thank you again. The digital replay of the conference call will be available beginning approximately noon Eastern Time today, February 10th, by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally.

Thanks, that's very helpful.

Okay.

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 all of you on our progress at our next investors call and thank you again.

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