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spk04: Good morning, ladies and gentlemen, and welcome to Veru, Inc.' 's investors conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fish. Veruz Inks, Executive Director, Investor Relations and Corporate Communications. Mr. Fuchs, please go ahead. Good morning.
spk08: The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, or they're not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolios. Such forward-looking statements are subject to known and unknown risk and uncertainties, and our actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or developments to differ materially are contained in our 10-Q and 10-K SEC filings, as well as in our press releases from time to time. I'd now like to turn the conference call over to Dr. Mitchell Steiner, Vera Williams Chairman, CEO, and President.
spk09: Good morning. With me on this morning's call are Michelle Greco, CFO, CAO, Michael Purvis, Executive Vice President, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Vero is dedicated to the development of novel medicines for the management of two of the most prevalent cancers, breast cancer and prostate cancer. One of our anti-cancer drugs, abysmobulins, has dual antiviral and anti-inflammatory effects, so it is also being developed for the potential treatment of hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome, which remains a global dire unmet medical need. The company has a commercial sexual health division called UREV, which includes two FDA-approved products, Intadfi, a new treatment for BPH, which is benign prostatic hyperplasia, and the FC2 female condom internal condom for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections. The revenue from the sexual health division is being used to largely fund the clinical development of our late stage drug candidate assets, which aim to address multi-billion dollar premium market opportunities. This morning, we will discuss Bureau's business strategy, the clinical development of our drug pipeline, and the commercialization of our products. We will also provide financial highlights for our first quarter of fiscal year 2022. COVID-19 global cases, hospitalizations, and deaths were at the highest level since the start of the pandemic. Some of the antibody drugs are not effective against the Omicron variant. It is clear that an effective and safe oral therapeutic that prevents deaths in hospitalized patients with moderate to severe COVID-19 infection who are at high risk for acute respiratory distress syndrome is desperately needed. We strongly believe that subisobulin with its antiviral and anti-inflammatory properties and a favorable safety profile can be that greatly needed oral therapy for hospitalized patients with COVID-19. Subisobulin disrupts the intracellular transport of the coronaviruses by microtubules. This is a process that's required by all variants of COVID-19, including Omicron, to cause infection. While there have been recent developments evaluating the Merck drug, Lomipiravir, and the Pfizer drug, Paxlovid, for the treatment of unhospitalized patients with mild to moderate COVID-19 who had a relatively low risk of dying, Sibizabulin, in contrast, is being developed for hospitalized patients with moderate to severe COVID-19 who are at high risk of death. Our positive phase two clinical study in hospitalized COVID-19 patients in high-risk for acute respiratory distress syndrome showed that subisobulin treatment resulted in a 82% relative reduction in deaths compared to placebo. If our phase two clinical results were replicated to any significant degree in our global phase three clinical study, we believe subisobulin will fill a significant unmet medical need for hospitalized patients. We are conducting a phase three COVID-19 clinical study which is a double-blind, multi-center, multinational, randomized, two-to-one placebo-controlled study evaluating daily oral 9-milligram dose of sabizapulin for up to 21 days versus placebo in 300 hospitalized COVID-19 patients with high risk for acute respiratory distress syndrome. Primary emphasis endpoint will be the proportion of patients who die in our study up to day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in the ICU, WHO ordinal scale for clinical improvement change from baseline, days on mechanical ventilation, days in the hospital, and viral load. Studies being conducted in the U.S., Brazil, Argentina, Mexico, Colombia, and Bulgaria. In January of 2022, the FDA granted fast-track designation for the Phase III COVID-19 registration program. a distinction that underscores the urgent need for new novel and effective therapies to be used along with vaccinations to combat this COVID-19 pandemic. The company has sufficient clinical drug supply on hand to complete the phase three clinical study and to help fund the commercial drug to supply the needs of the US population, assuming confirmatory positive clinical results and FDA approval. We're seeking funding from BARDA and other agencies. The company anticipates having the results of the Phase 3 COVID-19 clinical trial in the first half of the calendar year 2022. As for our breast cancer drug portfolio, we have an expansive metastatic breast cancer program with two of our drug candidates, Inovasarm and Subizabule. Inovasarm is an oral selective androgen receptor targeting agonist, which has shown efficacy in Phase 2 clinical studies in a heavily pretreated hormone receptor-positive metastatic breast cancer patient population with an excellent safety profile without causing unwanted masculinizing adverse side effects. Novus arm represents the first and novel endocrine therapeutic approach to breast cancer in decades. Our second drug candidate, tabizabulin, is an oral cytoskeleton disruptor that targets unique binding sites and cross-links microtubules. a well-validated cancer target resulting in promising efficacy and a favorable safety profile without clinically relevant neurotoxicity, neutropenia, or alopecia. Furthermore, chronic oral daily administration is feasible. Our clinical development strategy allows us to potentially become an important treatment option for a variety of large market opportunities in hormone receptor-positive metastatic breast cancer. In the third-line treatment setting for hormone receptor-positive metastatic breast cancer, we have two clinical programs based on the patient's androgen receptor nucleotide staining or expression levels in their breast cancer tissue. For patients with greater than or equal to 40% androgen receptor expression, we are actively enrolling a global Phase III ART test registration clinical study to evaluate Inovasarm monotherapy for the third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. Inovasarm targets the angioreceptor, which has tumor suppressor activity in AR-positive, ER-positive, HER2-negative metastatic breast cancer without causing the unwanted masculinizing side effects. Inovasarm has extensive non-clinical and clinical experience, having been evaluated in 25 separate clinical studies in approximately 1,450 patients' dose, including three Phase II clinical studies in advanced breast cancer involving more than 250 patients. This means we have a very good understanding of the favorable safety profile of the NovoSARM. As for efficacy, there were two Phase II clinical studies conducted in women with AR-positive, ER-positive, or 2-negative metastatic breast cancer, where the NovoSARM demonstrated significant anti-tumor efficacy in the heavily pretreated cohorts that developed tumor progression after receiving estrogen blocking agents, chemotherapy, and or CDK4-6 inhibitors. And again, in this population, Inovasarm was well tolerated with a favorable safety profile. We are conducting a phase three multicenter international open-label randomized one-to-one ART test registration clinical trial to evaluate the efficacy and safety of Inovasarm monotherapy versus an active comparator of either Eximestane, plus or minus Everolimus, or a selective estrogen receptor modulator for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer in approximately 210 patients with greater than or equal to AR expression in their breast cancer tissue who have previously received a non-steroidal aromatase inhibitor for ovestrin and a CDK4-6 inhibitor. In January of 2022, FDA granted fast-track destination to our Phase III R test registration program. Fast-track designation aims to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to fill unmet medical needs. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Patients who are found to have less than 40% AR expression in their breast cancer tissue. We have a planned sister study, which is an open-label, multi-center, randomized, one-to-one phase 2B study, evaluating the efficacy and safety of sabizabule of 32 milligrams monotherapy versus the active comparative of either XMS-10 plus or minus epirolimus or CIRM for the treatment of ER-positive, ER-positive metastatic breast cancer in approximately 200 patients who have previously received a non-steroidal limitase inhibitor fulvestrin and a CDK4-6 inhibitor. For clarity, this means we have a sister study to randomize patients that did not qualify for the Phase III-R test study because their AR expression in the breast cancer tissue was too low. We received the safe-to-perceive letter from FDA, and this Phase II-B study is expected to commence in calendar Q1 2022. We're also moving a NovoSom therapy earlier in the treatment sequence into the second-line treatment setting for AR-positive, ER-positive, HER2-negative metastatic breast cancer by targeting patients with AR-positive breast cancer expression of greater than or equal to 40% in a Phase III Enabler II clinical study. The CDK4-6 inhibitor and an estrogen blocking agent combination has become the first-line therapy for patients with ER-positive HER2-negative advanced breast cancer. Unfortunately, almost all patients will develop drug resistance and will eventually develop breast cancer progression. Based on positive Phase II clinical data and the preclinical data supporting the use of adenocarcinoma in combination with a CDK4-6 inhibitor in patients who are CDK4-6 inhibitor and estrogen-blocking agent resistant, we plan to conduct a Phase III multi-sensor open-label randomized one-to-one active control registration clinical study named ENABLED-2. ENABLED-2 evaluates the efficacy and safety of the NovoSAR and abemacyclid combination therapy versus an alternative estrogen blocking agent in subjects with AR-positive, UR-positive, HER2 metastatic breast cancer who have failed first-line therapy with palpocyclid, which is a CDK4-6 inhibitor, plus an estrogen blocking agent, and who have greater than or equal to 40% AR expression in the breast cancer tissue. Plans are involved approximately 186 patients in this Phase III clinical study. We recently announced that we have entered into a clinical trial collaboration and supply agreement with Lilly for the Enabler II Phase III clinical study. In terms of the non-exclusive clinical trial collaboration and supply agreement, Vera is responsible for conducting the clinical trial, while Lilly will supply a memocyclic for the study. Vera maintains full exclusive global rights to Novozarm. We're looking forward to our collaboration with Lilly on the Enabler 2 Phase 3 clinical trial, which is expected to commence in calendar Q1 2022. We're partnering with Roche Ventana, a major global diagnostics company, to develop a companion diagnostic angioreceptor test. In the Phase 2 801 study, we determined that the presence and the amount of the angioreceptor expression in breast cancer tissue are important for the novus arms targeted anti-tumor activity. In fact, we identified that patients who have greater than or equal to 40% angio-receptor staining by immunohistochemistry, which is a measure of angio-receptor expression in the breast cancer tissue, are the patients that are most likely to have an anti-cancer response to a novus arm. Based on this observation, the FDA recommended that we develop a companion diagnostic test to determine the patient's AR expression status. Consequently, we have partnered with Roche-Ventana Diagnostics, world leader in oncology companion diagnostic tests. We're developing and have approved plans to commercialize the companion diagnostic antireceptor test. The companion diagnostic test is being developed in parallel with the phase three R-test clinical study. Although the study, although the company has been planning to commence a single arm subisobulin plus a novus arm combination the metastatic triple negative breast cancer patients in a phase two clinical study that was supposed to start early in this calendar year. We have now decided to focus our finite resources on more advanced pipeline opportunities and suspend work on this trial. Nevertheless, the company remains committed to advancing triple negative breast cancer study in the future. As you can see, we have developed an important and deep breast cancer program dedicated to developing novel we have late clinical stage studies addressing three separate indications. The first indication is evaluating sebizobulin, the third-line treatment of metastatic castration-resistant prostate cancer in the phase three veracity study. Several novel angio-receptor-targeted... ...lutamine and apalutamine. Unfortunately, most men with metastatic castration-resistant prostate cancer will develop tumor progression while receiving an antireceptor-targeted agent with 60% to 70% of patients progressing by 12 to 18 months and 30% to 40% of men having no benefit at all. New, effective, and well-tolerated treatment alternatives that do not target the antireceptor axis and that have an easy mode of administration are greatly needed. Invisibulin is a member of a novel class of drugs that disrupts the cytoskeletons by targeting unique binding sites on microtubules, which results in improved safety profile. Preclinical models, there was no evidence of significant liver toxicity, neurotoxicity, and neutropenia with subvisivulin treatment. This more tolerable safety profile has also been confirmed in a first-in-man phase 1b2 study in metastatic castration resistant prostate cancer patients. We will be presenting updated clinical data from the positive phase 1B2 study of subisipulin in 80 men with metastatic castration-resistant prostate cancer who have progressed on at least one novel angio-receptor targeting agent at the ASCO Janitor Urinary Cancer Symposium being held February 17th and 19th in San Francisco, California. He's conducting an open-label 2-to-1 multicenter phase 3 veracity clinical study evaluating sebizobulin 32 milligrams versus an alternative angioreceptor-targeted agent for the treatment of chemotherapy-naive men with metastatic castrate-resistant prostate cancer who had tumor progression after previously receiving at least one angioreceptor-targeted agent. Primary endpoint is radiographic progression-free survival. Enrollment for the Phase III voracity clinical study is on track, and we expect to enroll approximately 245 patients from 45 clinical centers in the U.S. clinical study is evaluating VIR-100, a GnRH antagonist, a three-month depot formulation, in a phase two dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. Androgen deprivation therapy remains the mainstay primary therapy for advanced prostate cancer, but current androgen deprivation therapy drug products have several important clinical shortfalls. LHRH agonists' initial administration leads to a testosterone surge that can last up to 21 days. Thermagon, a GnRH antagonist, is a large-volume subcontinuous injection formulation designed for only a single-month release. And Regagolex is an oral GnRH antagonist, but it has the potential for poor patient compliance. In contrast, Vero 100 has a target product profile that addresses a number of these important clinical shortfalls of the currently commercially available androgen deprivation therapy products. Vero 100 is a long-acting GnRH antagonist designed to be administered as a small volume subcutaneous three-month depot injection. Vero 100 drug product is expected to immediately suppress testosterone with no testosterone surge. And Vero 100 is a long-acting injected depot with insured patient compliance while on treatment. Furthermore, as a class, GnRH antagonists have been shown to have fewer cardiovascular adverse than LHRH agonists. We're conducting a Phase II dose-finding clinical study of Vero 100 angio-deprivation therapy in 35 men with hormone-sensitive advanced prostate cancer. Although this study is ongoing, preliminary clinical data are promising. Registration clinical study design has already been agreed upon with FDA. It will be a single-arm study which will enroll approximately 100 men. Maintenance of castrate blood concentrations of testosterone is the primary endpoint. After the Phase II dose-finding study is completed, we will initiate the Phase III clinical study, which is anticipated to begin in calendar second half of 2022. In our third late-stage clinical study, we plan to advance suclomiphene for the treatment of hot flashes caused by antigen deprivation therapy in a planned Phase IIb clinical study later in the calendar year of 2022. So in summary, We'll have three late-stage clinical studies for the management of advanced prostate cancer in calendar year 2022. Now, Vero has a commercial sexual health division called URADS, which includes two FDA-approved products, FC2 for the dual protection against across the U.S. As a result, FC2 is now available through multiple sales channels. In particular, we have partnered with fast-growing, highly reputable telemedicine platform companies to bring our FC2 product to patients in a cost-effective and highly convenient manner. Sales is not only to seek additional telemedicine and internet pharmacy service partners, but also to create our own has been shown to be more effective for the treatment of benign prosthetic hypoplasia than finasteride alone without causing impotence. and TADP was approved by FDA in December of 2021, and commercialization plans are now underway. The plan is to officially launch TADP next quarter. TADP is expected to be marketed and distributed also by our own direct-to-patient telemedicine and internet pharmacy services platform. We have also partnered with GoodRx, a US-based digital resource for healthcare, to reach their almost 20 million monthly visitors which include both consumer and healthcare providers, to build awareness, to send patients to our telemedicine platform, and to convert existing men on BPH treatments, those treatments that cause sexual side effects, to Intazbi. There are over 45 million prescriptions filled annually for drugs to treat BPH. We plan to augment our marketing and sales efforts by seeking additional partners in the US and ex-US. I will now turn the call over to Michelle Greco, the CFO and CAO to discuss the financial highlights. Michelle?
spk05: Thank you, Dr. Steiner. As Dr. Steiner indicated, the company has a number of significant clinical challenges. Let's review the first quarter results. Net revenues were $14.1 million compared to $14.6 million in the prior year quarter. The prior year quarter included net revenues of $863,000 related to Preboost, which the company sold on December 8th of 2020. The company reported FC2 sales growth in its U.S. prescription business with net revenues up 27% to $11.6 million from $9.1 million in the prior year quarter. Net revenues for the public sector business were $2.6 million compared to $4.7 million in the prior year quarter. The prior year quarter included revenues related to the Brazil and South African tenders. Overall gross profit was $11.8 million or 84% of net revenues compared to $10.8 million or 74% of net revenues in the prior year quarter. The increase in gross profit and gross margin is driven primarily by increased sales in our USFC2 prescription business. This quarter's 84% gross margin is the highest in the company's history. Operating expenses for the quarter increased to $16.8 million compared to the prior year quarter of $10.1 million. The increase is primarily driven by research and development costs, which increased to $10.1 million from $5.7 million in the prior year quarter and increases in personnel and related costs to prepare to commercialize in TASI. During the prior year quarter, the company sold pre-boost for $20 million, $15 million in cash, and $5 million in notes receivable due in two installments over an 18-month period. The sale of pre-boost resulted in an $18.4 million pre-tax gain. The operating loss for the quarter was $5 million compared to operating income of $19.2 million in the prior year quarter. This change is primarily due to the gain on sale of pre-boost of $18.4 million plus the increase in research and development costs of $4.4 million. Non-operating expenses were $1.3 million compared to $1.3 $9 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 the synthetic royalty financing during March of 2018. For the quarter, we recorded a tax expense of $115,000 compared to $78,000 in the prior year quarter. The bottom line results for the quarter was a net loss of $6.4 million, or $0.08 per diluted common share, compared to net income of $17.2 million, or $0.23 per diluted common share in the prior year quarter. The company has net operating loss carry forwards for U.S. federal tax purposes of $38.6 million, with $29.5 million expiring in years through 2040, and $9.1 million, which can be carried forward indefinitely. And our UK subsidiary has net operating loss carry forwards of $63.5 million, which did not expire. Now looking at the balance sheet. As of December 31st, 2021, our cash balance was $116.1 million. Our accounts receivable balance was $8.1 million. And our notes receivable related to sale of pre-boost were $2.5 million. Our net working capital was $131.8 million at December 31, 2020, compared to $136 million at September 30, 2021. Overall, we're delighted to see the growth in the USFC2 prescription business and look forward to increasing sales in the global public sector business. This revenue source, together with our strong balance sheet, continues to be the source of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium oncology biopharmaceutical company seeking large market opportunities in breast and prostate cancers, as well as being opportunistic by joining the global efforts to find effective treatments for COVID-19. Now I'd like to turn the call back to Dr. Steiner.
spk09: Thank you, Michelle. In summary, we've had a highly productive financial first quarter, which has allowed us to significantly advance our clinical oncology programs. We've organized our FDA-approved products into a sexual health division called UREV. We're now entering our sixth year of growth in our FC2 US prescription business. We're executing on a solid plan to expand partnerships and to launch our own direct-to-patient telemedicine internet pharmacy services portal. We plan to commercially launch a TAPI, also via our own direct-to-patient telemedicine and international services portal. And we have partnered with GoodRx to drive awareness, and prescription conversion. Both programs should allow us to continue the robust growth of revenue from the UREP Sexual Health Division. Having these resources in place will allow us to continue to advance our deeply clinical stage breast cancer and prostate cancer programs, as well as a Phase III COVID-19 clinical study. We are quite pleased to have recently received fast-track designations from FDA on two of the company's major drug development programs this past month. We anticipate a steady flow of important positive news for VIRU over the next few months to one year. We're committed to driving shareholder value by developing, commercializing novel medicines, addressing significant unmet medical needs for the management of breast cancer and prostate cancer, and being opportunistic by developing subisobulin to hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome and death. With that, I'll now open the call to questions. Operator?
spk04: Thank you. Ladies and gentlemen, at this time we will begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure that 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 question queue. Once again, let a star then one to join the question queue. The first question today comes from Brandon Foulkes with Canton Fitzgerald. Please go ahead.
spk07: Hi, thanks for taking my questions and congratulations on all the progress. Maybe just first on the COVID program, just given that's the near-term catalyst. How do you view the bar having shifted or not on the COVID endpoints, especially around mortality? And then along those lines, do you think that the secondary endpoints alone could support an approval here?
spk09: So just say that first part about mortality again. So what about the primary endpoint?
spk07: Do you think that agencies have shifted their view on endpoints? Right? Versus, so if you don't, if we're not successful on mortality, do you think these secondary endpoints alone could still support an approval from the regulatory agencies?
spk09: Yeah, gotcha, gotcha, gotcha. So the answer is I don't think they're switching at all on the primary endpoint. I think that if you've seen some recent activity of some people reporting results and they're reporting results not on their primary endpoint. So at the beginning of any clinical trial, You state your primary endpoint. I'm not saying this to you, but I'm just saying this for the people listening on the phone. You have to hit your primary endpoint. I mean, that defines success in the trial. And mortality, you know, death, I mean, that's about the hardest endpoint you can get. You can't fake a death, and deaths are what we're trying to deal with in something as horrible as the pandemic. With that said, no, I do not think agencies are shifting their on their desire to see an impact in mortality. And so I think we're good there. However, having said that, let me just make one more comment. The other comment is, well, let me make this next comment and I'll make the one I was about to make. So to answer your question, there are key secondary endpoints that if you miss on mortality and you hit these other ones, there could be a discussion with FDA that these can stand on their own, but that's a discussion with FDA. Now, one thing that gives us comfort is, as you know, the space has gotten, quote, crowded in pre-hospitalized patients. So patients that are not in the hospital, it's no longer in their medical need. You've got the Pfizer drug, the Merck drug, and others. And so in that setting, there are options. And in the hospitalized setting, What we're learning now is the drug, in fact, the FDA has even said with the Omicron variant that some of these drugs, antibody drugs that are currently out there for people in a hospitalized setting should not be used. And so the fact that we got fast-track designation by FDA for hospitalized patients means it's still an unmet medical need. So in the event that you have an unmet medical need, and you have a secondary endpoint that's successful and you don't hit on mortality, that's a little different than there are other options out there. So in that setting, I think we have a lot of room to talk to FDA with the key secondary endpoints, if that's what you hit, in a setting of an unmet medical need. And, again, the unmet medical need is not what we're saying. It's the fact that we just got FDA fast-track designation means they also need Because remember, they see drugs in development, and they see drugs that are approved. And so that gives us some comfort. And we continue to work in a very important area on that medical need.
spk07: Great. Thank you very much.
spk09: Thank you.
spk04: The next question comes from Leland Gersholt with Oppenheimer. Please go ahead.
spk01: Hey, good morning. Thank you for taking my questions. wanted to ask Mitch with respect to your development in breast cancer, being that the androgen receptor appears to be a tumor suppressor in breast cancer, wanted to know, as you divide between those with AR expression above 40% and below 40%, how that breaks down with respect to the size of the fractions of the population with breast cancer with those levels of AR expression. Would the thinking be correct that more advanced er positive her to negative breast cancer would be more enriched in the ar given that those tumors are likely more resistant to therapy given their expression of ar and also want to ask with respect to intensity to the extent your your market research may indicate what what potential peak revenue might we expect for that product and given that you're selling that through the um telemedicine channels, you know, your own that you're setting up and others, kind of give us a sense of what your margins may be on that product. Thank you.
spk09: So the first question basically is trying to understand the patient population of AR positivity. So the way to look at it is that, and I had made this comment before, that, you know, men and women are born with the same machinery to make breast tissue. So why is it that Women develop breast tissue, men do not. And the answer is the same machinery means there's an estrogen receptor and there is an androgen receptor. So in women, estrogen and no androgens develops breast, and men, androgens and no estrogen, you don't get breast. So it's a tremendous tumor suppressor, tremendous suppressor of growth. So it's not surprising that up to 90% of breast cancer tissue will have an androgen receptor expression. And so now the question becomes, and the question you're asking is the enrichment part, in other words, greater than 40%, less than 40%. So when you look at the numbers, and this is based on our phase two, so about 85% of breast cancers are going to be ER positive. And of those 85% that are ER positive, about half of those will be AR positive greater than 40%. And so it's still a huge market. and pretty prevalent target that we can have an opportunity to hit. So 50% would be AR less than 40, and roughly 50% would be AR positive greater than 40, and that's the reason why we have the subisobulin trial, the sister trial, because we know when we go out there and start looking for patients with metastatic AR positive breast cancer, that half of them, roughly half of them, are going to be candidates for anobis arms. And so we've got another active agent in breast cancer, so why not allow that patient to have a choice of door number one or door number two. So door number one, if your antigen receptor is greater than 40% expression, you get to go on Inovasarm. And if you're less than 40%, you get to go on Subisibulin. So we get two bites of the apple there. So both of them are huge markets. So demographics are in our favor. Interestingly, We did see an independent presentation at the San Antonio Breast Cancer Meeting this past December that showed, and maybe this explains why the combination of a CDK4-6 inhibitor with a Novus arm could be interesting, because it turns out that this is not static. It's pretty dynamic, meaning the angioreceptor expression can change, and it can change with the actual treatment that you're getting. What the San Antonio study showed is that maybe one of the reasons why the combination of a CDK4-6 inhibitor and NovoSARM makes sense is that it turns out that the CDK4-6 inhibitor actually induces the upregulation or the expression of angioreceptor on breast cancer tissue. So another way of saying it is if a NovoSARM is trying to look for the angioreceptor and the CDK4-6 inhibitor makes more angioreceptor, that may explain the potential synergy between the two. So it's not just what's there in the 50-50, but it could be that there's a bigger population to go after because the CDK4-6 inhibitor will take somebody out of the 40% range and put them higher. But that's for another day. As it relates to intensity, we have not given guidance except to say that one, I mean, we think we're on some incredibly sure footing for a couple of reasons, okay? There really hasn't been a new BPH drug in many, many years. And so, you know, we would be the first new BPH drug. And as you know, all the BPH products have some sort of sexual side effect. And finasteride in particular, which is very, very popular and shrinks the prostate, one of the number one side effects it has and one of the number one sexual side effects it has is impotence. And by combining Finasteride with Tadalafil, and Tadfi now becomes not just a new BPH medicine, it is a, they call it a new chemical entity in a sense that it's not substitutable. So you can't substitute it. It stands on its own, which means it's branded. So we have a branded product that could have a branded price, will be viewed as branded by insurance companies, including Medicare. And so our pricing would be comparable to a branded product in the BPH space. And the fact that we don't have those sexual side effects of impotence in the combination compared to finasteride alone really gives us an opportunity to convert, you know, established patients who are having problems, that's a low hanging fruit, to us. Now to put this in perspective, The sales, I mean, the most recent at QVIA data that I've seen, you know, this is still about a billion-dollar market with 45 million prescriptions. And if you can convert, you know, 1% or 2% of those patients into a branded price, you're already starting to hit numbers that are well above $200 million. And that's with 1% or 2% of the total market being converted to a branded product. So we think there's a real upside here, but we have not given any guidance. We just believe it's a big market, that we have a differentiated product, that it's a branded price, and we're going to be taking advantage of telemedicine. And not only telemedicine, but we're going to take advantage of GoodRx, incredible breadth of being able to go out there. And I mean, GoodRx spends about $300 million or $400 million a year bringing people to their website. And it's not just consumers. It's also health care providers. And so to be able to drive awareness and to focus primarily digital advertising to those patients that are most in need so you're efficient with your resources gives a real opportunity. Can we hit 1% or 2%? Can we hit 3%? Can we hit 4%? It feels doable. And so this could be a very important product to help us continue to drive the robust revenue that we're seeing from UREP. And by putting TADC in with FC2, the two FDA-approved products, just ensures that we continue to maintain and largely pay for the clinical development of our products and do that, particularly in an environment where, you know, biotech looks like it's having a rough spell. But if you can look at our numbers and look at what we have in the bank, it looks like this model is working. And so if we can adjust what revenues come in, which is significant with our development program, it puts us in sure footing that our shareholders will see, you know, these multi-billion dollar opportunity products without seeing, you know, big dilution that typically happens in biotech companies that are constantly raising money every six months to 12 months.
spk01: Great. Thank you.
spk04: The next question comes from Chris Howerton with Jefferies. Please go ahead.
spk02: Hi, good morning, and thanks for taking the questions. Really appreciate all the progress and the color this morning, Mitch. Maybe just two questions from me. One would be, can we get a little more color around the strategic decision to no longer pursue triple negative breast cancer with just competition in terms of like Trodelvi and other options make that less commercially viable at this point? Or I guess, you know, what is some of the other thinking around pausing that program? And then the second one would be, Abema Ciklib, you know, could you just give us some thoughts around the market share and why that's the right partner for Inova SARM and what that might mean for the commercial opportunity? And let's say second line, HER2 positive. So thanks.
spk09: Yeah, two very, very good questions. Okay, so let's start with the first one. The first one is purely a prioritization decision. So we still believe that triple negative breast cancer is a major market. If you look at Tredelvi and, you know, they developed a compound for patients with metastatic triple negative breast cancer that have failed two systemic chemotherapies and that drug got bought by Gilead for $24 billion. So there's a market there. And we're, you know, we have two oral therapies, Anovasarm and Subizabulin, and we don't see, you know, the neutropenia and all the other stuff and the black box stuff that you see with Trideldi. So we think there's a real opportunity. But we had to make a financial decision. And the financial decision was that, as I mentioned in the previous question answer, is I don't know what's happening out there in the biotech space. I think a lot of companies are going to be in trouble if they think the markets are wide open for them to raise money. So our thinking is we've got money in the bank, so that is a real reason why we need to be prudent with our resources and prioritize our resources because, you know, it's one thing to have no money in the bank and prioritize and nothing to have money in the bank and prioritize. And so if you look at our burn rate, quote, the cash we use, it's small, okay? Why is it small? Because we've offset it with revenue coming from our sexual health business. So in order to make sure until I see the things open up, Then, you know, we've got a lot going on. We've got, you know, we've got three or four phase threes, and we've got a phase 2B, and you've got the other ones that soon can be a phase three. So we said, you know what, let's pause on the triple negative breast cancer program, and that will put our spend on clinical development pretty much matching what we think will be coming in with our revenue from the direct business so that we can wake up with significant resources from the bank at the end of the year And if it looks like we have more revenue coming in because of the TAS fee, then we can make further decisions to move another trial forward. So we're blessed in that we have new chemical entities that we own as a company and we have promise. But I think no one will get mad at us for seeing through some of these Phase III programs because it will put us in a different market cap and also different financial setting, so then we can move still other programs. So it's purely a prioritization play. It has nothing to do with the market. I think the market is a huge opportunity, but we're dealing with a lot of huge opportunities, and so we just have to prioritize. As it relates to your second question on Abema Cyclib, here's a very interesting point and why we thought it really made sense as a partner. So it turns out that the CDK, when we first got involved with breast cancer, people kept saying, oh, the field is crowded, the field is crowded, you're not going to be able to differentiate yourself. And, of course, that's not true because the androgen receptors were completely unexploited. And we thought by coming in with the androgen receptors, with the Novus arm, the first drugable, real drugable selective androgen receptor targeting agonists, that we had something that was new. But what changed the landscape was the CDK4-6 inhibitor. So people on the call, CDK4-6 inhibitor changed the landscape because it became the standard of care in first-line breast cancer treatment if you're ER positive, HER2 negative. And that's the largest population of breast cancer patients. And the company that owns that space right now is actually Pfizer. Because abemacyc, excuse me, palpocyclib in combination with an estrogen blocking agent is being used 80% of the time, 80% of the time, which means the other 20% is being fought over by Novartis' ribocyclib and Lilly's abemacyclib. Okay. And if you, and unfortunately, the fortunate part is women will see between 24 and 30 months of progression-free survival. which is unbelievable, but they will all unfortunately progress. And when they progress, there's really nothing approved and nothing in the NCCN guidelines that follows a CDK4-6 inhibitor. So this space is wide open. So it makes sense to go into second line with an agent that has shown in preclinical models that the combination of the Novus arm plus a CDK4-6 inhibitor has synergy, and that that synergy is probably related to the fact that the CDK4-6 inhibitor is increasing the angioreceptor, making a Novus arm work better. And so it's not just you're just adding two drugs together to see an additive effect, but it could really be a significant synergistic effect. And if that's the case, you need a CDK4-6 inhibitor. But what's a better situation to get a CDK4-6 inhibitor that is not being used in that 80% of patients in first line? So that means if 80% of patients in first line are using Palvo, they need a new one. And so that new one could be abemacyclin. So we're really positioning Inovacine. I hope you grab that 80% of patients that fail Palvo plus an estrogen blocking agent by now. Now they're going to be looking for something else. Maybe that something else will be abemacyclin. and a novus arm. And so it was very strategic to partner with Lilly on this one because their agent, which is a very good agent, and they came later to the game, could be in combination with a novus arm, the go-to combination after patients have failed first one.
spk02: That makes a lot of sense, and I really appreciate it. Thank you, Mitch.
spk09: Thank you.
spk04: The next question comes from Yi Chen with HC Wainwright. Please go ahead.
spk03: Thank you for taking my questions. My first question is, could you tell us whether the enrollment speed for the ARTEST study and the VERACITY study is meeting your expectation?
spk09: Yes, to answer your first question, the ARTEST and the VERACITY studies, both of them are rolling on track.
spk03: Got it. Thanks. And could you tell us what's your current expectation for revenue from NTAPI for this fiscal year?
spk09: Yeah. So thank you for the question. So I answered the, so somebody else, I think Leland also asked that same question. We have not given guidance as to what we think the revenue will be. What we have said is a couple of things. We said that there are $45 million prescriptions filled each year with BPH. We know that almost all BPH products are going to cause some sort of sexual dysfunction. We know that the finasteride products have impotence. We know the combination of finasteride and Tadalafil, which is in Tadfi, we do not see the impotence. And so we think there's a real opportunity to convert these patients to the combination therapy in Tadfi. But we also said in The BPH market looks like it's about $1 billion, and about 2% to 3% of that is branded products, which make up about $300 million or $400 million of that $1 billion. And so if we were able to convert 1% or 2% of that market towards intact fee, it could be big.
spk03: Okay. And regarding the triple negative breast cancer program, do you think there's a chance you might reactivate the program in the future, and how soon may that happen?
spk09: Yeah. So, as it relates to commitment and reactivating it, the answer is absolutely we're committed to reactivating it. So, it's purely a timing and prioritization of resources market conditions and the fact that we have so many phase threes going on, particularly COVID-19, that we felt that for an organization our size, we probably should pause on that, not spend that money, and keep our money spent very close to our revenue, not just revenue, the cash coming off the sexual health business, so that we can go another year with impressive money in the bank. And so that was the thinking. But, you know, things can change. If COVID-19 hits or if, you know, we find ourselves in a situation that TASI and FC2 continue to generate 30% to 40% growth in the past, you know, year after year, because we're going into our sixth year and we see something like that, then it'll be pretty easy. I mean, the protocol is written. You know, it's ready to go. We have the drugs. It's ready to go. So we can pretty quickly get it back on track. But this is purely a prioritization of resources to keep our spend within our cash coming off, as much as possible off the cash coming off the revenue-based business.
spk03: Got it, got it. And lastly, are there any parties that are interested in purchasing the UREP sector sales division from LaRue?
spk09: So the answer is, are there any parties interested in purchasing it? So the answer is, yeah, there are parties interested in purchasing it. The real question for us is making sure that it's the right value for our shareholders and to make sure that we take advantage of, you know, I mean, right now it's generating a lot of money for us. And it feels good to have that revenue base right now. We think there are things that we can do to make the sexual health division look even more attractive so that we can, you know, it's even more valuable. And that is by now going from a women's health company to a sexual health company. Instead of having a single product, now we have two products. And instead of using other telemedicine partners, we're going to become a telemedicine entity ourselves. And so all of those things will add more value to the base business. And while we're enjoying the cash flow coming from the base business, At the same time, we're also increasing the value of the base business so that when we're ready, we'll have some more options to monetize.
spk03: Great. Thank you.
spk04: The next question comes from Kumar Rajay with Brookline Capital Markets. Please go ahead.
spk06: Thanks for taking my questions and also congratulations on all the progress. First, with regard to COVID-19 stations, what are you seeing there? Is it fair to estimate that you are close to completion of enrollment given that you are planning to release data in the first half?
spk09: So make sure the question, it's a COVID-19 study and the question is, it's my phone breaking in and out, so I apologize.
spk06: In terms of hospitalization, what kind of trends are you seeing?
spk00: In terms of hospitalization?
spk06: Yeah, given that you are planning data in the first half, is it fair to expect that you are close to completion of enrollment? I see what you're saying.
spk09: Yeah, so the good news is that we're on track, you know, as I said in my formal comments, we're on track to have data, clinical trial results for the study, in the first half of this year. I will tell you that, you know, the hospitalizations have increased tremendously across the world, fortunately, for the patients, because we don't, you know, of course, we don't want to see that, but that's what's happening. As you know, hospitalizations and death lag behind new cases. And what's interesting is what we're seeing is that the cases that make it to the hospital and those ICU type patients, once they're on that slippery slope, we're finding that the death rates in patients that are at risk, especially those who are at risk for acute respiratory distress is similar to the other variants. It's just that the milder stuff, you see a lot of it, but the ones that finally make it to the hospital is a problem. If you know there's about 140,000 new hospitalizations a week And so it's the highest ever in the pandemic. It's higher than all the other three waves. So with that said, it's put us in solid footing to enroll and to get the data in the first half of the year. So all I'm going to tell you is that we believe that we will have clinical data in the first half of the year to end patients who are hospitalized, which, as you know now, There's no medicine available. And the fast-track status from the FDA is further confirmation that it's an unmet medical need. And if we can fill that unmet medical need with an oral agent that's not an infusion, that doesn't require cold storage so that you can put it in backpacks and get it to remote areas of the world. It's hospital-based as opposed to pharmacy-based. so that you can quickly get it mobilized into hospitals, as opposed to trying to get it to every pharmacy in the country. So from a distribution standpoint, it will be a lot easier. So I think we're kind of in the right space, right time, but we're on track to provide data in the first half of this year.
spk06: Okay, and with regard to Erebusome and Sabisa Bulin, what kind of interactions have you had with EMA And can the ongoing trials be leveraged for approval in Europe?
spk09: So as it relates to the EMA, you know, we have all our interactions have been with FDA. Our interactions with EMA for the international studies are to make sure we file the appropriate paperwork so that we can do the studies in Europe, which we have. But we have not gone to EMA to seek scientific advice or anything of that sort. mainly because our studies are pretty straightforward, but we will, as we get the enrollment going, and we'll go back to EMA and go back to Japan. But at this point now, our thinking is focus in the U.S., and when we partner the opportunity, the partner will have the wherewithal and the ability to do Japan and Europe at the same time, But, you know, we're successful in the U.S., which is the premium market, we'll be in good shape.
spk06: Okay. Finally, with regard to COVID-19 external funding, is the funding mostly for manufacturing?
spk09: Yes. And so, as you know, we're essentially almost done with the clinical study. Where we're going to need the most help is going to be in procurement and distribution. And if you, you know, Merck, I can't remember the number, but it was a big number, a billion something, and Pfizer got a billion something for procurement. So, you know, there's no risk to the government once you get an EUA, an emergency use authorization. You know, then the issue becomes, you know, the government needs to buy it and get it out there. And so if we're successful in our phase three and we have an EUA, we feel pretty strongly and we believe that we should be able to get external funding to help us with scale up and distribution. And so that's been our focus. Interestingly, after the wave of vaccines and antibody drugs, you know, BARDA has just gone silent in terms of funding these opportunities. But they're very, very active once you've shown efficacy and safety. And so we're going to take advantage of that window. Thanks so much. Thank you.
spk04: Ladies and gentlemen, this concludes our question and answer session. I would now like to turn the conference back over to Dr. Mitchell Steiner for any closing remarks.
spk09: Thank you, everybody. I appreciate you joining us on today's call, and I look forward to updating all of you on our progress in our next investors call. Thank you again.
spk04: The digital replay of the conference call will be available beginning approximately noon Eastern Standard Time. by dialing 1-877-344-7529 in the U.S. and 1-412-317-0088 internationally. You will be prompted to enter the replay access code, which will be 366-4461. Please record your name and company when joining. This conference has now concluded. Thank you for attending today's presentation.
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