Earnings Call Transcript - VERU Q1 2020

Operator, Operator

Good morning, ladies and gentlemen, and welcome to Veru Inc.’s Investor Conference Call. All participants will be in a listen-only mode. 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, Veru Inc.'s Director of Investor Relations. Please go ahead.

Sam Fisch, Director of Investor Relations

Good morning. The statements made on this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company’s current assessment of the risks and uncertainties related to our businesses. Our actual results and future developments could differ materially from the results or developments in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company’s product portfolio, risks related to the ability of the company to obtain sufficient financing on acceptable terms when needed to fund development and company operations, risks related to competition, government contracting risks, and other risks detailed in the company’s press releases, shareholder communications, and Securities and Exchange Commission filings. For additional information regarding such risks, the company urges you to review its 10-Q and 10-K SEC filings. I would now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.’s Chairman, CEO, and President.

Mitchell Steiner, Chairman, CEO, and President

Thank you, Sam, and good morning. With me in this morning’s call are Michele Greco, the CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company focused on developing novel medicines for the management of prostate cancer. Today, we will update you on the clinical development of our drug pipeline and the commercialization of our products as well as provide financial highlights for the first quarter of fiscal year 2020. It is estimated by the American Cancer Society that in 2020 there will be about 191,930 men with newly diagnosed prostate cancer, which is a 10% increase from 2019. An estimated 33,330 deaths from prostate cancer in 2020 represent a 13% increase from 2018. After following for two decades, this is the second year in a row that we have seen an increase in deaths from prostate cancer, suggesting that men with advanced prostate cancer are progressing through current treatments, and new effective treatments are urgently needed. We are delivering on our strategy to be the prostate cancer company. We are responding to this call to action and are dedicated to developing and commercializing products to address unmet medical needs for managing prostate cancer. The markets for prostate cancer management are well-established multi-billion dollar markets and given our core expertise and the number and type of drugs in our pipeline, we are uniquely positioned to understand, develop, and commercialize medicines for these unmet medical needs of prostate cancer patients. Here is a brief update on the advancement of the prostate cancer drug pipeline. We have made significant progress with our open-label Phase 1b/2 clinical trial for VERU-111, a novel proprietary first-in-class oral selective antitubulin agent for metastatic castration-resistant prostate cancer patients who have also become resistant to the novel androgen blocking agents enzalutamide or abiraterone, but prior to IV chemotherapy, also referred to as the pre-chemotherapy stage. These are the patients whose prostate cancer is progressing, meaning that it is spreading after exhausting the benefits of currently available injectable and oral prostate drugs but before they are offered IV Cabazitaxel taxane chemotherapy. Unfortunately, there is a large number of these affected men. According to the published scientific report, about 12% to 25% of men who have metastatic castration-resistant prostate cancer and who have been started on a novel androgen blocking agent will not respond at all to this therapy. About 75% of men will initially respond to treatment with an androgen blocking agent, but their tumor will start progressing in about 9 to 15 months. Essentially, by 1 year, the majority of these men will have tumor progression and will need the next therapy by VERU-111 to control their advancing prostate cancer. This pre-chemotherapy space in men who have failed in ADT and a novel androgen blocking agent is currently the fastest-growing unmet medical need segment in advanced prostate cancer. According to Accuvia, oral drugs, abiraterone and enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual sales. Men who have failed these novel blocking agents or the patients that VERU-111 is currently targeting represent an estimated $4.5 billion annual global market. Currently, there are no FDA-approved oral or IV drugs for the indication of men with advanced prostate cancer who have failed both ADT and one of the novel androgen blocking agents. In the Phase 1b clinical trial, we have treated 39 men to date who have metastatic castration and androgen blocking agent-resistant prostate cancer and have shown evidence of cancer progression by rising PSA levels and the spread of prostate cancer by CT and/or bone scans as per the study design, which is called a 3+3 design. The maximum tolerated dose or any side effect indicating that higher doses may not be tolerated is determined by treating 3 patients at a time with an oral daily dose of VERU-111 for 7 days followed by 2 weeks off-drug, making up 1 cycle. For patients to tolerate treatment, we increased the schedule to 2 weeks on drug and 1 week off and then 3 weeks continuously on drug until there is evidence of prostate cancer progression. This will allow us to assess the durability of the anti-cancer response. The escalating doses of VERU-111 tested to date are 4.5, 9, 18, 27, 36, 45, 54, 63, 72, and 81 milligrams a day. As for safety, VERU-111 appears to be generally well-tolerated. There are no reports of neutropenia up to and including 72 milligrams, which is the dose-limiting toxicity typically seen for IV taxanes. There have been no reported complaints of neurotoxicity or hypersensitivity reactions, common side effects that occur with IV taxanes. There have been a few isolated mild liver enzyme changes that in some instances resolved while still on the drug. Mild-to-moderate diarrhea, nausea, and vomiting have been reported, which appear to be dose-dependent. Furthermore, we know that through oral dosing, VERU-111 is being absorbed into the bloodstream from the stomach, as levels of VERU-111 are measurable in the blood, indicating good bioavailability. VERU-111 concentrations are higher with increasing oral drug doses. We have achieved VERU-111 blood concentrations in humans that match the efficacy concentrations we have measured in preclinical animal models where prostate cancer tumors shrunk. Although this is a safety study, we see preliminary evidence of anti-tumor activity as mentioned in prior earnings calls. Historically reported literature indicates that men with metastatic castration-resistant and androgen blocking agent-resistant prostate cancer have a median of 3.7 months before new evidence of cancer progression appears in CT and/or bone scans. In our Phase 1b, there are 20 men in the study that had the potential to be treated for 4.5 months. Even without having determined the optimal dose or a dosing schedule yet, there are 4 men still ongoing in the trial with no tumor progression at 12, 10.4, 10.4, and 7.6 months. All of these men have experienced PSA reductions from peak or baseline values, and another 6 men have progressed to 4.2 months. The patient still in the trial at 12 months had a PSA reduction of 63% from peak and had two cancerous lymph nodes shrink as measured by an initial follow-up CT scan and confirmed by another follow-up CT scan 3 months later. We also have another patient who at the time of enrollment had progressing prostate cancer bone metastases and now shows improvements of these bone metastases based on a bone scan following treatment with VERU-111. The anti-cancer effects in the study demonstrate a dose and schedule response, meaning higher doses and 3-week treatment cycles have shown more activity. Based on preliminary clinical data results, VERU-111 is a promising anti-cancer compound with a good safety margin and without the typical side effects seen with IV taxanes. Therefore, VERU-111 appears to be a good candidate for oral anti-cancer therapy in men with metastatic castration and novel androgen blocking agent-resistant prostate cancer in the pre-chemotherapy space. An advantage of VERU-111 is that it can potentially be prescribed by the urologists who are the usual physicians managing this type of patient. Once the Phase 1b is completed, we will present the full clinical dataset at an upcoming major scientific meeting. We are approaching a significant and important clinical milestone in the development of VERU-111. We are finishing up the last cohort of the Phase 1b portion of the Phase 1b/2 clinical study and will continue to collect long-term clinical data from this portion of the clinical trial. We will soon initiate the Phase 2 portion of the clinical trial enrolling approximately 26 men with metastatic castration and novel androgen blocking agent-resistant prostate cancer using the dose and schedule selected from the Phase 1b study. Given the current efficacy and safety profile of VERU-111, we plan to expand the clinical program of VERU-111 in 2020 into Phase 2 studies with 2 to 3 additional tumor types or indications where anti-cancer activity was shown in preclinical animal models. We will update you further when we have more information on these studies showing anti-tumor activity in other tumor types, which will increase the overall value of the VERU-111 program. Next, I will update you on VERU-100, our proprietary peptide drug candidate for the treatment of hormone-sensitive advanced prostate cancer, an established multi-billion-dollar global market. The target product profile of VERU-100 is commercially and scientifically compelling with a number of anticipated advantages over currently available androgen deprivation therapies. VERU-100 is a long-acting gonadotropin-releasing hormone, or GnRH antagonist, designed to be administered as a small volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it is intended to immediately suppress testosterone with no testosterone surge upon initial or repeated administration and no testosterone micro increases that may adversely affect patient outcomes. This is a problem that potentially occurs with the approved LHRH agonist drugs like Lupron, Zoladex, and Eligard. Currently, there are no GnRH antagonists commercially available for treatment beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot an attractive choice for androgen deprivation therapy. We have received agreement from the FDA that the development program for VERU-100 may follow an expedited pathway. Based on this FDA input, the company plans to commence a single open-label, multi-center, dose-finding Phase 2 clinical trial in approximately 60 men followed by a single open-label, multi-center Phase 3 clinical trial with approximately 100 men. Veru is in the process of scaling up GMP manufacturing drug products to prepare for the clinical trials of VERU-100. The company intends to submit an investigational new drug application in early 2020, so we can initiate the open-label Phase 2 clinical study by early summer. As it is an open-label Phase 2 study, we will be able to periodically update you on our progress towards reaching the primary endpoint, which is the reduction of testosterone to castrate levels in real-time during 2020. The planned development pathway for VERU-100, as agreed upon by the FDA, represents a lower-cost investment opportunity for a major product that could address the shortfalls of the current $2.6 billion global ADT market. Our next product candidate in a clinical trial is zuclomiphene, a novel proprietary oral non-steroidal estrogen receptor agonist being evaluated to treat hot flashes, the most common side effect in men on androgen deprivation therapy for advanced prostate cancer and a major reason why men want to discontinue androgen deprivation therapy. We have enrolled 93 men in a multi-center double-blind placebo dose-finding Phase 2 clinical trial evaluating two doses: 10 milligrams and 50 milligrams of zuclomiphene versus placebo. We reported positive top-line interim results a few weeks ago. We determined that the 10-milligram dose had no effect, but the 50-milligram dose of zuclomiphene demonstrated estrogenic activity and a reduction in the frequency of hot flashes from the baseline at Day 42. We also reported on the safety findings from the current blinded aggregate clinical database from our placebo-controlled trial. Based on the study’s interim findings, zuclomiphene appears to be well-tolerated. We have not received any reports of gynecomastia, painful breasts, or venous thromboembolic events, which are common side effects seen in men treated with high doses of estrogen. After an end of Phase 2 meeting with the FDA for the zuclomiphene program, we obtained agreement on the trial design that will be acceptable for approval. Our plan is to initiate a pivotal Phase 3 clinical study, and we will provide details of the design and timing of this study after meeting with the FDA. The expectation is that the Phase 3 design will be very similar to the Phase 2 study and that it will be a 12-week treatment study. Veru has determined that the peak U.S. revenue potential for zuclomiphene citrate is between $580 million to $630 million. This projection assumes that 25% to 33% of all ADT patients who experience hot flashes will take zuclomiphene, with an annual patient cost between $4,000 and $5,000. This estimate is based on research from Accuvia, medical marketing economics, and DelveInsight. This is independently confirmed, as zuclomiphene, with the indication of treatment for hot flashes in men undergoing androgen deprivation therapy for advanced prostate cancer, represents a significant market opportunity. Currently, there are no FDA-approved drugs for this indication. We are very excited about our progress with zuclomiphene for this unmet indication. Veru’s ability to advance the clinical development of our proprietary prostate cancer drugs addressing unmet medical needs in large markets is being substantially supported by investments from two commercial sources of revenue: the FC2 female internal condom and PREBOOST/Roman Swipes, which are 4% benzocaine wipes for premature ejaculation. As you can see from the earnings release, in Q1 of fiscal year 2020, we continue to see significant growth in revenue and gross profits from these commercial products. Although Ms. Greco will cover the detailed financial results highlights in a few moments, I would like to make a few comments. We continue to experience robust growth in fiscal year 2020 and expect further increases in FC2 sales in both the public sector and prescription sales in the U.S. for the rest of the year, as we have signed new agreements to supply FC2 by prescription through telemedicine companies. The strong growth in the U.S. FC2 prescription business remains noteworthy, as it is allowing us to be less reliant on the intermittent ordering patterns typically seen in our traditional FC2 public sector business. We had $6.1 million in revenue from the prescription business for Q1 of fiscal year 2020, compared to $2.4 million for Q1 of fiscal year 2019, an increase of 148%. To give you a sense of our growth trajectory for all of fiscal year 2019, we achieved 159,000 FC2 prescriptions, and for just Q1 of fiscal 2020, we had 81,000 FC2 prescriptions. For our premature ejaculation product marketed as Roman Swipes, the company entered into a multi-year U.S. distribution agreement with Roman Health Ventures, a premier and fast-growing men’s health and telemedicine company that discreetly sells men’s health products via the Internet at www.getroman.com. We are beginning to see these revenues grow too. Focusing now on Veru’s commercial segment, which includes FC2 PREBOOST/Roman Swipes and drug commercialization costs, we had net revenue increases in Q1 of fiscal year 2020 to $10.6 million compared to $6.4 million in Q1 of fiscal year 2019, which reflects a 66% increase. Gross profits for fiscal year 2020 were $7.3 million compared to $4.6 million in fiscal year 2019, representing a 57% increase. Our income from operations in this segment was $5.8 million for Q1 of fiscal year 2020, up from $3.4 million in Q1 of fiscal year 2019, marking a 73% increase. As you can see, our base commercial business is performing very well and, as a standalone business, would be quite valuable, experiencing significant revenue growth. With continued revenue growth and profit positive cash flow from this base commercial business, we have been able to substantially fund the development of our prostate cancer clinical programs and our urology specialty pharmaceuticals over the past year. We intend to continue this revenue growth trajectory not only with the current growth from FC2 and PREBOOST but also from the anticipated revenues generated from the commercialization of the company’s proprietary tadalafil and finasteride combination capsule for treating the symptoms of BPH called TADFIN. We expect this to be the company’s first pharmaceutical urology asset to move into commercialization. We are collecting 12-month stability data on TADFIN manufacturing batches and expect to submit the NDA by the end of 2020. In the U.S., we are exploring commercially launching TADFIN through telemedicine channels, as we have seen great success with this sales avenue. We are also in discussions with potential commercial partners outside the U.S. Having TADFIN revenues from U.S. sales and potential partnerships with upfront payments and royalties from outside the U.S. should add substantial near-term revenues with high gross margins to the existing and growing revenue streams from FC2 and PREBOOST/Roman Swipes products. I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights.

Michele Greco, CFO and CAO

Thank you, Dr. Steiner. As Dr. Steiner indicated, we started off the year with a great first quarter. FC2 unit sales totaled $10.1 million, up 36% over the prior year first quarter of $7.4 million. FC2 net revenues for the quarter totaled $10.4 million, an increase of 65% from the prior year quarter of $6.3 million. In the U.S., FC2 prescription channel net revenues were $6.1 million, an increase of 148% over the prior year quarter of $2.4 million. Net revenue for the public sector business also increased to $4.4 million from $3.9 million in the prior year quarter. Net revenues for PREBOOST/Roman Swipes were $153,000 compared to $47,000 in the prior year quarter. Gross profit increased $2.7 million to $7.3 million for a gross margin of 69%, compared with $4.6 million for a gross margin of 73% in the prior year quarter. The reduction in gross margin is due to an increase in labor, transportation, and equipment maintenance costs. FC2 net revenue per unit was $1.04 compared to $0.86 in the prior year quarter. The increase in U.S. prescription volumes resulted in the increase in our net revenue per unit and the subsequent boost in our gross profit. This increase in revenue provided the company with the cash necessary to continue funding its research and development projects. Research and development costs were $5.3 million compared to $2.4 million in the prior year quarter, reflecting an increase of $2.9 million. Operating expenses increased $3.4 million to $9.1 million from the prior year quarter of $5.7 million. The increase in operating expenses is primarily due to the rise in research and development expenses for our multiple advancing drug product candidates. The operating loss for the quarter was $1.8 million compared to $1 million in the prior year quarter. During the quarter, non-operating expenses increased approximately $553,000 compared to the prior period, primarily due to changes in the fair value of derivative liabilities. For the quarter, we recorded a tax benefit of $77,000 compared to a tax expense of $92,000 in the prior year quarter, mainly due to changes in the valuation allowance recorded against U.S. net operating losses. After income taxes, the bottom line result for the quarter was a net loss of $3.3 million or $0.05 per share compared to a net loss of $2.1 million or $0.03 per share in the prior year quarter. The increase in net loss of $1.2 million primarily stems from the rise in research and development costs. The company has net operating loss carry-forwards for U.S. federal tax purposes of $42.7 million, with $14.4 million expiring in years 2022 through 2038 and $28.3 million which can be carried forward indefinitely. Our UK subsidiary has net operating loss carry-forwards of $61.7 million, which do not expire. Now, turning to our balance sheet. As of December 31, 2019, our cash balance was $4.2 million, and our accounts receivable was $6 million, compared to a cash balance of $6.3 million and accounts receivable of $5 million at September 30, 2019. During the quarter ended December 31, 2019, we used cash of $2.5 million for operating activities, compared with using cash of $1.5 million in the prior period. Overall, we are delighted to see the continued increases in sales in the U.S. FC2 prescription market, the growing global public sector sales, and the increasing sales of PREBOOST/Roman Swipes to Roman Health Ventures. These revenue sources will continue to be a critical source of funds to invest in our promising pharmaceutical clinical programs as we continue to transform our company into the prostate cancer company. Now, I would like to turn the call back to Dr. Steiner.

Mitchell Steiner, Chairman, CEO, and President

Thank you, Michele. We have enjoyed yet another strong financial quarter, allowing us to significantly advance our clinical programs. In fact, we have now had nine strong quarters of growth in our FC2 U.S. prescription business. Looking forward to the rest of fiscal year 2020, we expect our revenues to continue to be strong and grow towards a record year. With the improving performance of commercial products and a strengthening of the balance sheet, we believe that we will be able to substantially invest in the continued development of our prostate cancer and other cancer drug product candidates as well as submit NDAs, and if approved, commercially launch TADFIN, which would provide more revenue to the already growing revenues from FC2 and PREBOOST/Roman Swipes. We anticipate a steady flow of important positive news for Veru over the next few months to a year. For VERU-111, our oral anti-selective antitubulin, we will report open-label efficacy and safety clinical results from the Phase 1b and Phase 2 clinical trials for VERU-111 for pre-chemo metastatic castration and novel androgen blocking agent-resistant prostate cancer. We will initiate new open-label Phase 2 clinical studies in other indications and tumor types. For VERU-100, our novel peptide GnRH antagonist 3-month depot formulation, we will complete GMP manufacturing of the clinical supply for VERU-100, submit the IND, and complete the Phase 2 clinical trial. For zuclomiphene, our oral estrogen receptor agonist, we will have an end of Phase 2 meeting with the FDA and initiate a pivotal Phase 3 clinical trial evaluating zuclomiphene for the treatment of hot flashes in men undergoing androgen deprivation therapy for advanced prostate cancer. We will submit the NDA for TADFIN, secure partnerships for some of our drug products, and continue to demonstrate robust growing revenues for our commercial products, FC2 and PREBOOST/Roman Swipes. We are committed to driving shareholder value by becoming the prostate cancer company while providing substantial benefits to prostate cancer patients by developing and commercializing products to address unmet medical needs in managing this disease. With that, I will now open the call to questions. Operator?

Operator, Operator

[Operator Instructions] The first question today comes from Brandon Folkes of Cantor Fitzgerald. Please go ahead.

Brandon Folkes, Analyst

Hi, thanks for taking my questions and congratulations on all the progress during the quarter. Firstly, is there any additional color on the baseline characteristics of the four men on VERU-111 that you called out who have responded very well? Secondly, can you just talk – I know it’s jumping a bit ahead, but about the competitive environment you would expect for VERU-111 when it comes to market within prostate cancer? Thank you.

Mitchell Steiner, Chairman, CEO, and President

Thank you. Alright. So the first question can I give you some more insight on the baseline characteristics of the four men that have shown good imaging progression-free survival, meaning they have not progressed and are well beyond what would have been expected for patients of this type. I can’t provide details on the individual patients, but I will share some information about the patients in general who have entered the study. In prostate cancer, the most common place that cancer spreads is the lymph nodes and bones. When it spreads to visual disease like the liver, that’s called visual disease. So, in this study, almost all the patients either have bone metastases, node involvement, or both. That’s why I commented on a node in one patient, for example, shrinking, which was confirmed with follow-up CT and bone scans. This gives you a flavor of a typical patient that a urologist sees. When a patient starts getting visual disease meaning it has spread to the liver or adrenal glands, those patients are further along in the disease and most likely will be followed by medical oncologists. Regarding the competitive market, right now, this is the fastest segment growing. The treatment modalities are coming in. At this point, just to be very clear, there are no drugs approved for patients that fail ADT and one of the androgen blocking agents. Almost every patient is starting to be treated with these agents even as early as non-metastatic disease, meaning when they develop their first metastatic lesion, they will have gone through ADT and one of these androgen blocking agents. First-line therapy is wide open for treating these patients. Once you use one of these androgen blocking agents whether abiraterone, enzalutamide, apalutamide, or darolutamide, you can’t use them again, because you won’t get much benefit from lowering testosterone further. So you need a drug or approach that has a new mechanism. Currently, the only approved drugs for metastatic castrate-resistant prostate cancer are docetaxel and cabazitaxel, which are taxanes. This means the patient has to leave oral therapy and go to a medical oncologist, which is not ideal as it means the physician cannot continue managing the patient’s care. We believe that VERU-111 offers a tremendous competitive advantage, as we are a cytotoxic therapy without many of the side effects associated with traditional cytotoxic agents. For example, taxanes are cytotoxic therapies that work, but they come with dose-limiting neutropenia, febrile neutropenia, sepsis, neurotoxicity, where patients cannot feel their fingers or toes, hypersensitivity, and the requirement of IV infusions. If we have an oral drug, based on Phase 1b data, we are not seeing the neurotoxicity or neutropenia issues, which means it can be given at home, providing the opportunity for urologists to step in before patients must transition to more invasive treatments. In my opinion, this creates a favorable competitive landscape for VERU-111, particularly as we begin to understand the drug's side effect profile, thus positioning us as the next preferred option for treatment.

Brandon Folkes, Analyst

Right guys. Thank you very much. Could I maybe just sneak in one more housekeeping question about how we should think about the spending for the rest of the year going forward?

Mitchell Steiner, Chairman, CEO, and President

You broke up, say that one more time.

Brandon Folkes, Analyst

How should we think about operating expenditures for the rest of the year going forward? Thank you.

Mitchell Steiner, Chairman, CEO, and President

We should view our budget considering the upcoming Phase 3 and Phase 2 studies for VERU-100. Based on our current plans, it appears that our revenues and gross profits will meet our necessary expenditures, so we are optimistic about that. As previously guided, we did not raise funds last year. This year, we feel confident, though next year could be a different scenario. There’s a balance to strike between making sure our income matches our needs versus accelerating programs that show promising results. As of now, we feel secure but do wish to keep accelerating, as it brings us closer to patient treatment sooner rather than later.

Operator, Operator

The next question today comes from Leland Gershell of Oppenheimer. Please go ahead.

Leland Gershell, Analyst

Hey, good morning Mitch. Thanks for taking my questions. Just a question on 111, if you could remind us of the two to three indications that you are looking at in addition to your current focus and also when might we see the first presentation of data, perhaps at a medical meeting this year? And then just a quick follow-up? Thanks.

Mitchell Steiner, Chairman, CEO, and President

Yes. So for the two to three indications, you’ve heard me mention in past calls that we are looking into pancreatic cancer, breast cancer, and post-taxane prostate cancer. At this point, we are focusing on completing the prostate study before starting on others. I can answer your second question about presentation of information; our data from the Phase Ib trial is maturing very well, and we are closing the last cohort, which means we can quickly initiate the Phase 2, since it is all part of the same plan, with approvals for Phase 1b and 2 already in place. While completing the first chapter, the patients who are responding to the drug will continue to stay on it, allowing us to gather further information regarding the durability of response and long-term safety. I think we will find a major scientific meeting where the full dataset will be presented. We aim to present at a significant meeting in the first half of 2020, such as ASCO, which is this weekend. However, we will find another major scientific meeting to showcase our full dataset. We will keep you updated as we get closer to starting those studies.

Leland Gershell, Analyst

Okay, great. And then with the Phase 3 zuclomiphene set to start after the end of the Phase 2 meeting with the FDA, can you remind us of the sample size you expect, based on the powering assumptions from the data you have, and when might we see the Phase 3 data from that program? Thanks.

Mitchell Steiner, Chairman, CEO, and President

The way we anticipate the study will take shape is after the end of Phase 2 meeting, we will outline the exact sample sizes, effect sizes, and overall size of the study. Currently, we expect to be looking at about 120 patients per arm, leading to a study size of approximately 240 to 260 patients in total. The trial is expected to involve a 12-week treatment period, which is consistent with our operational plans. We believe it will take approximately 6 to 9 months to enroll that study and then an additional 12 weeks to gather data, indicating that we could see the results in about a year or so after we start the study.

Operator, Operator

[Operator Instructions] And the next question comes from Kumar Raja of Brookline Capital Markets. Please go ahead.

Kumar Raja, Analyst

Thanks for taking my questions. So Mitch, regarding VERU-111, I wanted to gauge what correlations you are seeing concerning efficacy versus the side effect profile as you are dose-escalating. Additionally, how might this data inform follow-on trials with the other indications?

Mitchell Steiner, Chairman, CEO, and President

To clarify, your second question refers to how the knowledge we gain from the Phase 1b might apply to other tumor types?

Kumar Raja, Analyst

Yes, that's correct.

Mitchell Steiner, Chairman, CEO, and President

Let me address your second question first: in our animal models, our drug has shown activity in every tumor type we tested, whether it’s pancreatic, lung cancer, triple-negative breast cancer, as well as various forms of prostate cancer. The observed dosing patterns show that the concentration needed to provoke a tumor response must align with the human equivalent dose we’ve seen. We are watching for dose-dependent results as we increase the drug’s concentration. We are seeing a clear correlation where low dosages yield lesser tumor responses, while elevated dosages result in greater responses. As we progress to higher dosages in our trials, we are pulling two levers: the dosage itself and the schedule of administration. We are seeing that higher doses and more consistent schedules lead to improved anti-cancer activity. Regarding side effects, we have recognized a point at which the drug’s concentration yields strong anti-cancer effects with minimal adverse effects, leading to a well-tolerated profile at higher dosages. However, side effects do emerge as expected, specifically within the gastrointestinal tract, where cells divide rapidly. Hence, we anticipate possible side effects such as nausea, vomiting, and diarrhea. Nevertheless, those are manageable. We are not seeing neurotoxicity or severe effects on neutrophil counts like those observed in traditional cytotoxic therapies.

Kumar Raja, Analyst

Thank you. One more question regarding the growth of the FC2 product. It appears the U.S. business is thriving. What are your long-term growth expectations for this segment?

Mitchell Steiner, Chairman, CEO, and President

Great question. I don’t want to sound overly optimistic, but there’s a vast market ahead for us. This is what we have been able to tap into regarding a unique sales channel for FC2 through telemedicine, enabling significant revenue without traditional marketing expenditures. It’s striking that these telemedicine groups are utilizing their resources to market products to patients, allowing us to capitalize further on this platform for sales. Each week, we hear of new telemedicine websites emerging. The telemedicine market is expanding rapidly, and our company is effectively gaining from this development without additional marketing costs. Our sales are driven by the telemedicine groups' outreach rather than our own marketing budget. Presently, less than 0.1% of the $2.6 billion in the male condom business is derived from female condoms, so we have significant room to grow. The key is that as we continue to reach new patients utilizing the FC2 product, we’ll see ongoing revenue growth supporting our clinical program investments and positioning Veru as an innovator in women's health. Thus, I feel optimistic about maintaining this growth trajectory. It has already allowed us to attain nine quarters of consistent growth, providing reliable cash for our clinical programs, and I see it paving the way for a record year ahead.

Kumar Raja, Analyst

Okay, great. Thank you so much.

Operator, Operator

The next question today comes from Peter McMullin, a Consultant.

Peter McMullin, Consultant

Can you hear me, Mitch?

Mitchell Steiner, Chairman, CEO, and President

I hear you, Peter. How are you doing?

Peter McMullin, Consultant

Good. Thank you. Mine is more of a marketing question. I believe you are going to ASCO over the next few days; what are your plans regarding presence at that event and the opportunity to expand your stakeholder base?

Mitchell Steiner, Chairman, CEO, and President

Great question. We have adopted a philosophy of demonstrating rather than merely discussing. We now possess substantial information flowing from our cancer programs that we can showcase, signifying a record year for our data-driven promotion efforts. Dr. Harry Fisch and I, both urologists, can leverage our reputations within the urology community and prostate cancer circle. We are forging connections with thought leaders to introduce our products and innovations. I know they are excited about VERU-111, as it fills a gap for urologists who wish to maintain their patients' care. Historically, when diagnosed with advanced prostate cancer, patients had a life expectancy of about 18 months; today, in many cases, it extends beyond twenty years. These advanced prostate clinics are springing up across the nation, prioritized by urologists, who often have their own pharmacies to better manage their patients’ treatment timelines. New therapies have spurred interest, and there’s a heightened demand for innovative drugs. Our plans at the GU ASCO include presenting two abstracts—one related to our GnRH antagonist proof-of-concept results, and another addressing a survey we sponsored regarding hot flashes among patients on androgen deprivation therapy. These are data-focused presentations to drive interest in our products. It’s set to be a pivotal weekend for us as we transition from Phase 1b to Phase 2 and prepare for significant data revelations this year.

Peter McMullin, Consultant

When will you present, and does it cover both days or is it just Thursday and Friday?

Mitchell Steiner, Chairman, CEO, and President

It’s structured to be on Thursday and Friday, one each day. It should be listed in the session schedule of the GU ASCO meeting. As for timing regarding our press release, I believe we will have one shortly stating the dates, details, and summaries of our presentations, so be on the lookout for that.

Peter McMullin, Consultant

Good luck, and thank you.

Operator, Operator

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.

Mitchell Steiner, Chairman, CEO, and President

Thank you, operator. 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.

Operator, Operator

The digital replay of the conference will be available beginning approximately noon Eastern Time today, February 12 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 10138979. Please record your name and company when joining. The conference has now concluded. Thank you for attending today’s discussion. You may now disconnect your lines.