Good morning, ladies and gentlemen, welcome to Veru Incorporated Investors Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I'd now like to turn the conference call over to Mr. Sam Fisch, Veru Incorporated's Director of Investor Relations. Please go ahead.
Good morning. The statements made on this conference call may be forward-looking statements. Forward-looking statements may include, but are not necessarily limited to, statements of the company's plans, objectives, expectations, or intentions regarding its business, operations, finances, and development and product portfolio. Such forward-looking statements are subject to known and unknown risks 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. I'd now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO, and President.
Thank you, Sam , good morning. With me on this morning's call are Michele Greco, CFO and CAO, Michael Purvis, EVP, General Counsel, Corporate Strategy, and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is a late clinical stage oncology biopharmaceutical company with a focus on developing novel medicines for the management of two of the most prevalent cancers, prostate cancer and breast cancer. We're also committed to developing an effective drug therapy for COVID-19, which is a phase III program. We invest cash generated from our sexual health commercial business into the clinical development of our potentially high-value oncology and COVID-19 drug candidates. This morning, we will discuss the progress of our late clinical stage prostate cancer and breast cancer drug programs, as well as sabizabulin phase III study for the treatment of COVID-19.
We'll then provide financial highlights for our record Q3 fiscal year 2021. Veru anticipates having four registration clinical trials in prostate cancer, breast cancer, and for COVID-19, and two potentially registration-enabling clinical trials in breast cancer up and running by the end of the calendar year 2021, for a total of six potentially pivotal studies. Two of these, Phase III VERACITY study in prostate cancer and the Phase III COVID-19 clinical study, have already commenced. We have been very busy executing on this bold plan, and you will see that we're making significant progress.
In our prostate cancer clinical program, the company has initiated and is enrolling two clinical trials, the phase III VERACITY study to evaluate sabizabulin for the treatment of metastatic castration and androgen receptor targeting agent-resistant prostate cancer, and a phase II dose-finding clinical study for VERU-100, a GnRH antagonist three-month long-acting depot delivery formulation for androgen deprivation therapy of advanced hormone-sensitive prostate cancer. Sabizabulin is an oral first-in-class new chemical entity that targets cross-links and disrupts alpha and beta tubulin subunits of microtubules to disrupt the cytoskeleton. In prostate cancer, this also results in the disruption of androgen receptors transport from the cytoplasm into the nucleus. The phase I-B/II clinical study enrolled 39 men in the phase I portion and 41 men in the phase II portion. The phase II portion is completely enrolled and is still ongoing.
The safety of sabizabulin appears to be similar to the androgen receptor-targeted agents like abiraterone and enzalutamide, based on what has been reported in their package inserts. Long-term daily chronic drug administration appears to be feasible and safe. We have patients in the phase I-B portion that have been on treatment for over two years without evidence of prostate cancer tumor progression. At the recommended phase II dose of 63 milligrams, the most common adverse events were mostly Grade 1 and 2 diarrhea, fatigue, and nausea. There have been no clinically relevant reports of neutropenia, neurotoxicity, or hair loss. The phase I-B/II study also has yielded promising and significant efficacy outcomes. The efficacy results show PSA declines in responses, as well as objective and durable tumor responses, including partial and complete responses.
For the intent to treat population of all men with measurable disease at baseline, which is 29, the objective tumor response rate is 21%, in all men that received 63 milligrams or greater dose of sabizabulin, which is 55 men, the median radiographic progression-free survival has not been reached as the study is still ongoing, but it's estimated to be greater than 7.4 months. We initiated this past quarter the Phase III VERACITY clinical study, which is an open label 2-to-1 randomization study evaluating the efficacy and safety of sabizabulin 32 milligrams oral daily dosing versus an alternative androgen receptor-targeted agent in men with metastatic castration-resistant prostate cancer who have failed at least one androgen receptor-targeted agent, but prior to IV chemotherapy. Primary endpoint is median radiographic progression-free survival.
The trial assumptions expect the median radiographic progression-free survival of 7.4 months for sabizabulin versus 3.7 months for the alternative androgen receptor-targeted agent, which if achieved, would represent a doubling in the improvement of median radiographic progression-free survival and With sabizabulin compared to the active control. The study statistical assumptions to estimate sample size of 245 subjects included using an alpha of 0.05, a power of 98%, and a dropout rate of 30%. We expect enrollment to take 10 months recruitment time and 12 months follow-up after the last patient's first dose. The study is open and enrolling patients in 45 clinical sites across the United States. The lead principal investigator is Dr. Robert Dreicer. He's a deputy director at the University of Virginia Cancer Center, Director of Solid Tumor Oncology, and Professor of Hematology and Oncology.
In summary, sabizabulin is an oral agent with a novel targeted mechanism of action that, based on scientific literature and package insert, has a similar safety profile as a novel androgen receptor-targeted agent, and sabizabulin has efficacy that's at least comparable to, if not better, than IV docetaxel chemotherapy in this patient population. Chronic oral administration is feasible. So far it appears we have met our clinical target product profile goal of having an agent that can be prescribed prior to IV chemotherapy by both urologists and medical oncologists. Sabizabulin could be potentially the next go-to drug to be prescribed in the management of men with metastatic castration and androgen receptor-targeting agent resistant prostate cancer. Current global sales for androgen receptor-targeted agents like abiraterone, enzalutamide, and apalutamide are approaching $6 billion. Unfortunately, all men will develop resistance to these drugs and have prostate cancer progression.
This means that the only other option they will have is to proceed to IV chemotherapy. Thus, sabizabulin, if approved, will address a large part of the metastatic prostate cancer market. Next, I will update you on VERU-100, a long-acting androgen deprivation therapy for the treatment of hormone-sensitive advanced prostate cancer. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as the foundation of treatment throughout the course of the disease. Furthermore, androgen deprivation therapy is continued even as other endocrine chemotherapy or radiation treatments are added or stopped. Standard medical practice for urologists and medical oncologists is to administer androgen deprivation therapy every three to four months in their office. These injections coincide with the follow-up office visits and imaging assessments for metastatic or advanced prostate cancer.
Furthermore, these injections are administered as a buy and bill product and are reimbursed under Medicare Part B, not Plan D, so the urologist is compensated for both the drug and administering the drug. Patients' compliance is 100% once the injection has been administered. Most physicians strongly prefer injections over oral agents. gonadotropin-releasing hormone antagonist treatments or GnRH treatments versus agonists are preferred because castration occurs rapidly with no surges or flares in testosterone. Testosterone levels also tend to be lower, which is better for tumor control. GnRH antagonists also lower FSH levels, which is thought to be the reason why there are fewer cardiovascular side effects with GnRH antagonists versus GnRH agonists. There are no GnRH antagonist depot injection formulations currently approved for treatment beyond a one-month duration.
VERU-100 is a novel proprietary long-acting peptide, three-month subcutaneous depot formulation injection designed to address the current limitations of commercially available agents for androgen deprivation therapy. In this past quarter, we have initiated and are enrolling a phase II dose-finding clinical study evaluating VERU-100 in 35 men. We expect to have clinical data to report by year-end. The open label phase III registration study, whose design has already been agreed upon by FDA, will evaluate the efficacy and safety of VERU-100 in approximately 100 men with hormone-sensitive metastatic prostate cancer and is anticipated to start at the end of the calendar year of 2021. Next, I will discuss the progress of our breast cancer program. Veru is planning to initiate the following breast cancer studies during this half of the calendar year.
A phase III ARTEST clinical study evaluating enobosarm monotherapy in a 3rd-line metastatic setting in women with AR-positive, ER-positive, HER2-negative metastatic breast cancer who have progressed following estrogen blocking agents and a CDK4/6 inhibitor. A phase II-B clinical study evaluating enobosarm in combination with abemaciclib, a CDK4/6 inhibitor, in a 2nd-line metastatic setting in women who have progressed following 1st-line palbociclib, a CDK4/6 inhibitor, in combination with an estrogen blocking agent. A phase II-B clinical study evaluating sabizabulin monotherapy and sabizabulin plus TRODELVY combination therapy versus TRODELVY monotherapy in women with metastatic triple-negative breast cancer that have failed at least 2 chemotherapies. By way of background, the most common type of breast cancer, which occurs in about 85% of women, is ER-positive breast cancer, where estrogen is 1 of the main drivers of proliferation, tumor progression, and metastasis.
Consequently, treatments that target and block the estrogen receptor are the mainstay of breast cancer therapy. According to the 2020 National Comprehensive Cancer Network guidelines, the recommended first-line treatment in the metastatic setting is either a non-steroidal aromatase inhibitor in combination with a CDK4/6 inhibitor or fulvestrant in combination with a CDK4/6 inhibitor. The recommended second-line treatment in a metastatic setting is fulvestrant in combination with CDK4/6 inhibitor if a CDK4/6 inhibitor was not used in the first-line metastatic setting. Unfortunately, almost all women being treated with these regimens will eventually develop resistance to estrogen-blocking agents and the CDK4/6 inhibitor therapies, and there are limited clinical data that allow recommendation for a treatment containing another CDK4/6 inhibitor for these patients.
Alternative treatment approaches that target novel pathways will be required as there are limited treatment options following CDK4/6 inhibitor and estrogen blocking agent resistance in the management of ER-positive, HER2-negative metastatic breast cancer. Interestingly, like the estrogen receptor, the androgen receptor is found in over 85% of breast cancers. The androgen receptor is a tumor suppressor in estrogen receptor positive breast cancer. This means that when the androgen receptor is activated, it strongly suppresses ER-positive breast cancer growth. This explains why historically, when synthetic androgens were used to treat breast cancer, they demonstrated good efficacy. Unfortunately, the masculinizing side effects such as facial hair acne, increase in hematocrit liver toxicity, have prohibited their use as a viable treatment.
In contrast, enobosarm, an oral first-in-class new chemical entity, is a selective androgen receptor-targeted agonist that is being developed for the treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer and would represent the first new endocrine therapy for advanced breast cancer in decades. Enobosarm has extensive non-clinical and clinical experience, having been evaluated in over 25 separate clinical studies involving more than 2,100 subjects, including five prior phase II clinical studies in advanced breast cancer involving more than 250 patients. In addition to suppressing AR-positive, ER-positive breast cancer cell proliferation and tumor growth, enobosarm has other potential beneficial clinical properties. In pre-clinical studies, enobosarm has demonstrated that it builds and heals cortical trabecular bone and therefore has the potential to treat the osteoporosis caused by the estrogen deprivation and cancer skeletal-related events.
Enobosarm has also been shown to build muscle and to improve physical function in clinical studies involving elderly subjects and patients with cancer cachexia, including breast cancer patients. Furthermore, because of its tissue selectivity, enobosarm has a favorable side effect profile with no masculinization, no increase in hematocrit, and no liver toxicity. Two positive phase II studies involving approximately 150 women with AR-positive, ER-positive metastatic breast cancer were conducted. The G200802 phase II study was a two-arm study that evaluated nine milligrams and 18 milligrams of enobosarm daily oral dosing in 136 women with AR-positive, ER-positive, HER2-negative advanced breast cancer. The patients in the 802 study were heavily pretreated, having failed on an average of three estrogen-blocking agents, and 88% had received prior chemotherapy.
In this study, clinically meaningful tumor responses were observed with enobosarm monotherapy. It strongly establishes the relevance of targeting the androgen receptor with a selective androgen receptor agonist in women that were heavily pretreated with estrogen-blocking agents and were resistant and had AR-positive, ER-positive metastatic breast cancer. Enobosarm appears safe and well-tolerated without masculinizing effects, increase in hematocrit or liver toxicity. Quality-of-life measurements demonstrated overall improvement, including mobility, anxiety, depression, and pain. The 9-milligram dose was selected for our phase III study. The 9-milligram cohort compared to the 18-milligram cohort had a similar tumor response but a slightly better toxicity profile. Furthermore, most importantly, we also performed a post hoc subset analysis of this phase II clinical data to evaluate the relationship of the androgen receptor status with enobosarm anti-tumor efficacy.
The subset analysis showed that the presence of the androgen receptor and the amount of the androgen receptor expression in the breast cancer tissue predicted those women who are more likely to have a positive response to enobosarm. More specifically, the subset analysis combined randomized subjects in both the 9 milligram and 18 milligram cohorts who had known androgen receptor status determined by a central lab and who had measurable disease, and that was 84 subjects. The cutoff of greater than or equal to 40% AR expression appeared to be the best level to enrich for subjects that were most likely to respond to enobosarm. The clinical benefit rate at 24 weeks was 52% at greater than or equal to 40% AR staining versus 14% for less than 40% AR staining. That P value was less than 0.0004.
The best objective tumor response, that's partial responses plus complete responses, was 34% at greater than or equal 40% AR staining versus only 2.7% for less than 40% AR staining, and that P value was less than 0.0003. The median radiographic progression-free survival was 5.47 months at greater than or equal to 40% AR staining versus 2.7 months for less than 40% AR staining, when that P value is less than 0.001. Using this 40% cutoff, 57% of all women with AR positive, ER positive, HER2 negative metastatic breast cancer would qualify for treatment with enobosarm. Thus, the presence and the degree of androgen receptor expression in breast cancer tissue was important for enobosarm's antitumor activity, which is consistent with enobosarm being a targeted agent or biomarker that could select or enrich for subjects most likely to respond to enobosarm therapy.
As recommended by FDA based on these clinical data, AR expression status by immunohistochemistry will be validated as a companion diagnostic test and as a critical inclusion criterion in our clinical trial design. We're collaborating with a large global diagnostic company, which we'll announce when our agreement's complete, that has the expertise to help us with the development and validation of an AR companion diagnostic test in parallel with our phase III-ARTEST clinical study. By targeting the androgen receptor in ER-positive metastatic breast cancer, enobosarm introduces a novel endocrine therapy to patients with breast cancer that have exhausted estrogen-blocking agents and CDK4/6 inhibitors, but prior to IV chemotherapy. We are developing enobosarm in two major indications in ER-positive, HER2-negative metastatic breast cancer. The first indication is to evaluate enobosarm monotherapy in a third-line metastatic setting.
We will conduct this Phase III-ARTEST registration study as an open label, multi-center, multi-national, randomized 1-to-1 active control pivotal study evaluating the efficacy and safety of enobosarm 9 mg daily oral dose versus an active control, which is either going to be exemestane plus or minus everolimus or SERM, it's a physician's choice, in centrally confirmed greater than or equal 40% AR staining, AR positive, ER positive, HER2 negative metastatic breast cancer subjects who have failed a non-steroidal AI, fulvestrant, and a CDK4/6 inhibitor. The primary endpoint is median radiographic progression-free survival. The statistical assumptions include an estimated median radiographic progression-free survival of 6 months for enobosarm monotherapy versus less than three months for the active control with an alpha of 0.05, 99% power, and a 20% dropout rate. The sample size will be approximately 210 subjects.
We expect enrollment to take 10 months recruitment time and 12 months follow-up after the last patient's first dose. We expect that the androgen receptor companion diagnostic test will be developed in parallel with the Phase III-ARTEST study with our diagnostic company partner. The Phase III-ARTEST study will be conducted in 49 clinical sites across the U.S. and Europe and is anticipated to commence soon. The second indication to evaluate enobosarm plus a CDK4/6 inhibitor combination therapy in a second-line metastatic setting. We will conduct a Phase IIb clinical trial to evaluate the efficacy and safety of enobosarm plus a CDK4/6 inhibitor abemaciclib combination versus an alternative androgen blocking agent, either fulvestrant or a aromatase inhibitor in an AR-positive, ER-positive, HER2-negative metastatic breast cancer patients who have failed their first-line therapy, which is commonly palbociclib, a CDK4/6 inhibitor, plus an estrogen blocking agent.
This is an open label, 2-to-1 randomization clinical study in approximately 186 subjects and is expected to commence in a few months. Both of these indications represent large market opportunities as palbociclib global sales are approaching $6 billion in breast cancer, and unfortunately, almost all of these women will develop resistance to palbociclib and have tumor progression. The goal is to position enobosarm as the next go-to attractive option in both the second-line and third-line setting for AR positive, ER positive, HER2 negative metastatic breast cancer. Next, I will update you on the third clinical study in our breast cancer program, a phase IIb clinical study for chemotherapy-resistant metastatic triple-negative breast cancer. Metastatic triple-negative breast cancer is an aggressive form of breast cancer that is present in approximately 15% of all breast cancers.
This form of breast cancer does not express the estrogen receptor, progesterone receptor, or HER2, and is resistant to estrogen-blocking agents. Thus, the first line of treatment usually consists of multiple systemic chemotherapies, including IV taxane chemotherapy. Unfortunately, almost all of these women will eventually develop resistance and exhibit tumor progression. In preclinical studies of human triple-negative breast cancer that has become resistant to paclitaxel, which is a taxane, sabizabulin significantly inhibits cancer proliferation, migration, metastasis, and invasion. We plan to initiate an open-label, three-arm, phase II-B clinical trial to evaluate the efficacy and safety of oral sabizabulin monotherapy and sabizabulin-TRODELVY combination therapy versus TRODELVY monotherapy in the treatment of approximately 216 subjects in a 1:1:1 randomization in metastatic triple-negative breast cancer patients who have failed at least two systemic chemotherapies. The primary endpoint will be objective tumor response rate to ORR.
In human prostate cancer trials, chronic oral daily administration of sabizabulin is well-tolerated, and there was no reports of neutropenia. By the way, it will be interesting to see whether sabizabulin in combination with TRODELVY could result in less neutropenia with better efficacy, similar to what has been observed in the recently reported successful metastatic non-small cell lung cancer clinical trial with plinabulin, an IV colchicine site targeted antitubulin with a similar mechanism as sabizabulin in combination with docetaxel prevented the docetaxel-induced neutropenia, improved radiographic progression-free survival and overall survival even compared to docetaxel. The phase II-B clinical study is planned to commence soon. The clinical development of sabizabulin in metastatic breast cancer represents a second major clinical oncology indication for sabizabulin. Next, we will discuss our third clinical program, sabizabulin 9 milligrams for the treatment of hospitalized patients with COVID-19 who are at high risk for acute respiratory distress syndrome.
Sabizabulin in this setting is a novel once daily orally dosed small molecule with both broad antiviral and anti-inflammatory activities, which may serve as a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to acute respiratory distress syndrome and death. We conducted a double-blind, randomized, placebo-controlled phase II clinical trial evaluating once daily oral dosing of sabizabulin 18 milligrams versus placebo in 39 hospitalized COVID-19 patients who were at high risk for acute respiratory distress syndrome. In the intent to treat population, sabizabulin reduced the proportion of patients who died on study from 30%, 6 of 20, in the placebo group to 5.3%, 1 of 19, in the sabizabulin-treated group. That P value was 0.044. This is an 82% relative reduction in mortality in the sabizabulin-treated group. sabizabulin also showed significant and clinically meaningful reductions in days in the ICU.
Sabizabulin on average is three days versus placebo, 9.55 days. Sabizabulin reduced the days on mechanical ventilation from an average of 5.4 days in the placebo group to 1.6 days in the sabizabulin-treated group. Sabizabulin was well-tolerated with a good safety profile. We're currently enrolling a COVID-19 phase III clinical trial, which is a double-blind, multicenter, multinational, randomized 2-to-1 placebo-controlled trial evaluating daily oral doses of 9 milligrams sabizabulin for up to 21 days versus placebo in 300 hospitalized COVID-19 patients, of which 200 subjects will be treated with sabizabulin and 100 subjects will receive placebo who are at high risk for acute respiratory distress syndrome. Subjects in both the sabizabulin and the placebo arms will be allowed to receive standard of care. The primary efficacy endpoint will be proportion of patients who die on study up to day 60.
Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO ordinal scale for clinical improvement, change from baseline, days on mechanical ventilation, days in the hospital, and viral load. The study is being conducted in the U.S., Brazil, Argentina, Mexico, and Colombia. Enrollment's on track to be completed by calendar year-end. The company has sufficient clinical drug supply on hand to complete this phase III clinical study. We are still seeking funding from the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services, BARDA, and other agencies to try to fund the estimated amount of commercial drug to supply the needs of the U.S., assuming confirmatory positive clinical results and FDA approval. We believe we have the resources to conduct our planned sabizabulin for COVID-19 phase III without impacting our other cancer drugs clinical development.
As you're aware, we're not out of the woods with COVID-19 pandemic. COVID-19 cases, hospitalizations, and deaths are once again increasing in nearly all states and are fueled by the Delta variant, which is much more contagious than the past versions of the virus. Other variants are still emerging. The highest spread of cases with severe outcomes is happening in places with low vaccination rates. COVID-19 infection rates and hospitalizations are at a serious level, and the CDC is reversing their recommendations back to those used during the peak of the pandemic. There's no doubt we have had a major setback in the fight against COVID-19. It is clear that an effective and safe oral therapeutic that can prevent deaths in hospitalized patients with moderate to severe COVID-19 disease who are at risk for acute respiratory distress syndrome is desperately needed alongside an effective vaccination campaign.
We strongly believe that sabizabulin with its anti-inflammatory and antiviral properties and its favorable safety profile can be that greatly needed oral therapy. Based on the strength of these phase II clinical study promising clinical results, the company continues to be duty bound during this persistent global pandemic to pursue this COVID-19 indication, even though it's not the primary focus of the company. Finally, I will comment on ENTADFI. ENTADFI is our combination tadalafil 5 milligram, finasteride 5 milligram capsule developed to treat lower urinary tract symptoms caused by benign prostatic hyperplasia. The combination product contains tadalafil, which is approved for the treatment of BPH and erectile dysfunction, and finasteride for BPH. Our PDUFA decision date for ENTADFI is in December of 2021. We plan to launch TADFIN, if approved, via digital marketing and telemedicine channels.
When launched, it should be a near-term source of additional revenue for Veru to invest in our promising oncology pipeline. Although Ms. Greco will provide the full financial highlights in Veru's commercial segment, which is FC2 and drug commercialization costs, I am happy to report that we've achieved another record quarter and year-to-date. In fact, our nine-month year-to-date revenue increased 48% to $46 million, which has already beat the revenue of $43 million we had for the entire fiscal year of 2020. Our growing base commercial business, which is now in its fourth year of growth, and the prospect of additional growing revenue from FC2, plus the future revenue from TADFIN, places Veru on solid financial footing to have the resources to continue to invest in our promising premium drug pipeline for large market opportunities.
I will now turn the call over to Michele Greco, CFO, CAO, to discuss the financial highlights. Michele?
Thank you, Dr. Steiner. As Dr. Steiner indicated, we're having another great year. In December, the company sold PREBOOST for $20 million. In February, the company completed an equity raise, which resulted in $107.9 million in net proceeds after deducting underwriting commissions and costs. In the third quarter, the company achieved record level net revenues and gross profits related to the sales of FC2. For the first three months of fiscal year 2021, our net revenues were $45.6 million, surpassing $42.6 million in net revenues for the entire fiscal year of 2020. We have already achieved a record year for net revenues versus any prior full fiscal year after only three quarters. Let's start our highlights with third quarter results for the three months ended June 30th, 2021.
Overall, net revenues were up 71% to $17.7 million from $10.3 million in the prior year Q3 due to the growth of our FC2 U.S. prescription business. The company reported significant FC2 sales growth in its prescription business, with net revenues up 150% to $13.5 million from $5.4 million in the prior year Q3 . Gross profit rose 113% to $13.9 million, or 79% of net revenues, compared to $6.5 million, or 63% of net revenues in the prior year Q3 . The increase in gross profit and gross margin is driven primarily by increased sales in our U.S. FC2 prescription business. Operating expenses for the quarter increased to $16.7 million compared to the prior year quarter of $7.9 million. Research and development costs were $11.2 million compared to $4.4 million in the prior year quarter due to the commencement of several new phases in our clinical trials.
The operating loss for the quarter was $2.9 million compared to $1.4 million in the prior year quarter. In the prior year, the company received a forgivable loan of approximately $540,000 under the Paycheck Protection Program of the CARES Act. The forgivable loan was treated like a government grant and recognized as a reduction in operating expenses during the quarter. As a result, we recorded a reduction to selling general and administrative expenses of approximately $420,000 and a reduction to payroll-related research and development costs of approximately $120,000. Non-operating expenses were $2.7 million compared to $1.4 million in the prior year third quarter and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.
For the quarter, we recorded a tax benefit of $2.9 million compared to a tax expense of $241,000 in the prior year Q3 . The tax benefit recorded for the quarter is primarily due to the increased value of the U.K. net operating losses due to an increase in the U.K. tax rates from 19% to 25%. The bottom line result for the Q3 of fiscal year 2021 was a net loss of $2.7 million, or $0.03 per diluted common share, compared to a net loss of $3 million, or $0.05 per diluted common share, in the prior year third quarter. Turning to the results for the nine months ended June 30th, 2021. For the first nine months of fiscal year 2021, total net revenues were up 48% to $45.6 million from $30.8 million in the prior year period. Again, a record high for any fiscal year.
The company reported growth in FC2 sales in the U.S. prescription business and in the global public sector business. Net revenue from the U.S. prescription business was up 79% to $32.9 million from $18.4 million in the prior year period. Net revenue for the global public health sector business was up 6% to $11.8 million from the nine-month period. Overall, gross profit was $35.6 million, or 78% of net revenues, compared to $21.2 million, or 69% of net revenues in the prior year period. The increase in gross profit and gross margin is due primarily to the increase in the U.S. prescription business and a decrease in labor, transportation, and equipment maintenance costs.
Operating expenses increased by $14.5 million- $39.2 million compared to the prior year period of $24.7 million. The increase is primarily driven by research and development costs, which increased by $10.8 million to $24.4 million from $13.7 million in the prior year period. Operating income for the period was $14.8 million, compared to an operating loss of $3.5 million in the prior year period, an increase of $8.3 million. The increase is primarily due to the gain on sale of PREBOOST of $18.4 million. Excluding this gain, we had an operating loss of $3.6 million for the period. Non-operating expenses were $5.9 million compared to $3.6 million in the prior year period, and primarily consisted of interest expense and change in the fair value of the derivative liabilities related to the synthetic royalty financing.
For the 9-month period, we recorded a tax benefit of $2.8 million, compared to a tax expense of $30,000 in the prior year period. The company has net operating loss carryforwards for U.S. federal tax purposes of $42 million, with $13.8 million expiring in years through 2040 and $28.2 million, which can be carried forward indefinitely. Our U.K. subsidiary has net operating loss carryforwards of $61.3 million, which do not expire. The bottom line results for the first nine months of fiscal year 2021 was net income of $11.7 million, or $0.14 per diluted common share, compared to a net loss of $7.1 million or $0.11 per diluted common share in the prior period. Excluding the gain on the sale of PREBOOST, the adjusted net loss was $6.7 million or $0.09 per diluted common share in the current period. Turning to our balance sheet.
As of June 30th, 2021, our cash balance was $123.2 million. Our accounts receivable were $8.3 million. Due to our sale of PREBOOST in December, we added $15 million in cash during December and $5 million in notes receivable, which will be collected over the next 10 months. In February, we completed an underwritten public offering of 7,419,354 shares of our common stock at a public offering price of $15.50 per share. Net proceeds were $107.9 million. Our net working capital was $137.2 million at June 30th, 2021, compared to $12.3 million at September 30th, 2020. During the nine months ended June 30th, 2021, we used cash of $14.8 million for operating activities, compared with $1.6 million used for operating activities in the prior period. Overall, we're delighted to see the continued increases in sales in the FC2 business.
This revenue source, together with our strong balance sheet, continue to be the sources of funds we use to invest in our promising pharmaceutical clinical development programs as we continue to transform our company into a premium oncology biopharmaceutical company seeking large market opportunities. I'd like to turn the call back to Dr. Steiner.
Thank you, Michele. Our company's fundamentals are strong. We have enjoyed another strong record financial quarter with also another record for U.S. FC2 prescription net revenues, which has allowed us to significantly advance our clinical programs. Based on year-to-date performance, we'll have a record year in revenue. With the robust performance of the commercial business, plus the prospects for additional future revenues from TADFIN, coupled with our strong cash position, we believe that we'll be able to substantially invest in the continued clinical development of our prostate and breast cancer drug product candidates, as well as the sabizabulin COVID-19 phase III clinical study. We plan to continue to generate robust growing revenues for our sexual health business. We have successfully transformed our company into a late clinical stage oncology biopharmaceutical company, supported by growing revenue from our cash-generating sexual health business.
We are already currently enrolling or plan to enroll a total of nine pivotal or potentially pivotal studies this calendar year for major indications and large market opportunities. To summarize, in the prostate cancer clinical program, the company has initiated and is enrolling two clinical trials. Prostate cancer remains a very serious cancer as it is the second leading cause of cancer deaths in men. The drug product candidates that we're developing over two important indications. First, VERU-100, a GnRH antagonist three-month depot delivery formulation of androgen deprivation therapy of advanced hormone sensitive prostate cancer, has attributes to address the commercial limitations of other androgen deprivation treatments. The phase II dose-finding clinical study is enrolling, and we expect to report results in the second half of the calendar year, and the phase III clinical study has already been agreed upon by FDA, is expected to be initiated shortly thereafter.
The second major indication and market opportunity takes advantage of the adoption and the widespread use of androgen receptor-targeted agents, which have moved very early in the care of advanced prostate cancer. Almost all men will develop resistance to these drugs and their prostate cancer will progress. The market for androgen receptor-targeted agents is approaching $6 billion annually. We're developing sabizabulin, an oral agent, has the efficacy that appears to be similar, if not greater, to what has been reported in the literature for chemotherapy, but has side effect profile that's similar to what has been reported in the package inserts for androgen receptor-targeted agents.
This will allow sabizabulin, if approved, to be prescribed by both urologists and medical oncologists for men after progressing on androgen receptor-targeted agent, but before IV chemotherapy. The phase III VERACITY clinical study to evaluate sabizabulin for the treatment of metastatic castration and androgen receptor-targeted agent-resistant prostate cancer is enrolling. In the breast cancer program, the company expects to initiate three clinical trials soon. Breast cancer also remains a very serious cancer, as it is also the second leading cause of cancer deaths in women. ER+ breast cancer occurs in 85% of all breast cancers. The standard of care now uses CDK4/6 inhibitor in combination with an estrogen-blocking agent in the first and second-line metastatic settings. Almost all women will become resistant to CDK4/6 inhibitor, and the standard of care in this setting is now being defined.
The drugs we are developing are for two important indications in AR-positive, ER-positive breast cancer using companion diagnostic for selecting women who have greater than equal to 40% AR staining in breast cancer tissue, which would represent approximately 50% of all women who are ER positive with metastatic breast cancer. The first indication for enobosarm monotherapy is in the third-line setting. The second indication is a phase II-B clinical study that will evaluate enobosarm in combination with abemaciclib, a CDK4/6 inhibitor, in a second-line setting. Enobosarm, by targeting and activating the androgen receptor, represents the first new hormone therapy in breast cancer in decades. For the other 15% of women that have triple-negative breast cancer, we plan to initiate the phase II clinical study evaluating sabizabulin monotherapy and sabizabulin plus TRODELVY combination therapy versus TRODELVY monotherapy in women with metastatic triple-negative breast cancer who have failed at least two chemotherapies.
The goal is to see if sabizabulin alone or in combination with TRODELVY will have better efficacy and safety profile, specifically possible protection against neutropenia than TRODELVY alone. We're enrolling a phase III clinical trial to evaluate sabizabulin in hospitalized COVID-19 patients who are at high risk for ARDS. We're still in the middle of a global pandemic. The fact is that COVID will be a long war. We have witnessed evidence of this over and over. The bottom line is that although we have effective vaccines for now, we still need effective drugs to win the war. We have to continue to be steadfast in the execution of our phase III clinical study. If we confirm the promising results observed in the completed phase II clinical study, we expect to seek emergency use authorization for this indication. We are committed. COVID is not going away.
In summary, we have a portfolio of premium late clinical-stage drug candidate products for large global market indications. We expect a stream of steady, positive news flow achieving clinical trial milestones and reports of clinical trial data. We are open to the possibility of a pharmaceutical partnership if it enhances shareholder value, and we have a rapidly growing commercial-based business, which affords us strategic options. With that, I will now open the call to questions. Operator.
Ladies and gentlemen, at this time we will begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, we ask that you please pick up your handset before pressing the keys to ensure the best sound quality. To withdraw your question, please press star then two. Please limit yourself to one question and one follow-up. If you have further questions, you may reenter the question queue. Once again, that is star then one to rejoin the question queue. We'll pause momentarily to assemble our roster. Our first question comes from Brandon Folkes from Cantor Fitzgerald. Please go ahead.
Hi, thanks for taking my questions, and congratulations on all the progress. Maybe firstly, just having transformed Veru into an oncology company, you do have a fair amount going on. Do you have any sense of urgency to sell the FC2 business just to streamline the company and reinvest those funds? Along those lines, any change in thinking about whether you may fund the COVID program yourself once you see the data? Thank you.
Yes. Brandon, thank you very much for both questions. The first question is, given that we clearly have transformed ourselves into a oncology company, and there's no doubt now with the phase IIIs and the phase II-Bs that we're on track for two of the major cancers in areas that have large markets. We feel very good about that. Interestingly, with the FC2 business, we're looking for strategic options. The strategic options have been most interesting that we're not in a rush. The key word that you used was urgency. There's no real urgency because, look, it's generated $45 million.
Nine months
This last nine months. If we stay on track with that same growth, we're essentially bringing in the amount of money we need to fund all of our clinical trials. If you look at it that way and you look at the cash in the bank, we raised $107, we got $120, whatever number, $130, we add the accounts receivable, almost to $140 million. We're not burning through our cash. We're in a very interesting position that we're in the driver's seat to see what we want to do with the asset. By the way, strategic options doesn't always mean sell the business. There can be other things that we can do that can enhance shareholders' value and allow our shareholders to get the best of both worlds. We're working through that. No urgency.
It's not taking our eye off the ball, which is to continue to push and execute on the oncology side. As it relates to your second question, what I said relating to COVID-19 and whether or not we're prepared to fund it after we report positive results. As I mentioned in my prepared remarks that we have the resources and we have the clinical trial supply, drug supply. We're going to be able to run this study without losing a beat. We're not dependent on external funding for that. If we have successful data, we're going to be in a very interesting position, again, because even though we have begun to increase the scale-up of sabizabulin because of the multiple trials that are going on, including COVID-19.
It's a different level of production that you need to do to get ready for the U.S. population and the world. With that said, we will see. I think if we're at a 9-milligram dose, you don't need a lot of drug to begin, and it's only a 21-day treatment, and we can do the treatments at seven-day intervals. There's a lot of flexibility to try to, quote, "Spread the drug as quickly as we can." The ideal situation would be just like you saw recently with Merck, that the government will step in and provide the resources required to scale up so that the drug will be available for the masses, including outside the U.S. We'll continue to move in that direction because, as I said, we've already taken care of the resources and the drugs that we need to do the phase III.
I do think if we have positive data, given the environment that we're in right now and the fact that people are so fatigued, but they're also realizing that this COVID thing is not going away. We have not turned a corner. We had this whole discussion that it looked great, everything was opening up. I'm hearing some of the conferences are starting to get canceled again. We're stuck, guys, and we're only going to win this with a vaccine and a drug. I do think that the mood for funding will change dramatically as people step in with positive data.
The next question comes from Yi Chen from H.C. Wainwright. Please go ahead.
Thank you for taking my questions. The first question is, has the Delta variant in any way affected the enrollment speed?
The answer is yes, and let me tell you why. When we started the clinical trial, and you can go back and look, we said we opened the COVID-19 phase III. The U.S. contribution to the trial enrollment became incredibly anemic. The reason it became incredibly anemic is because the rates of hospitalization and deaths just disappeared. I have a person that I call at each of these ICU to see what's happening. He goes, "Mitt, it's crickets now. It looks like we've licked this thing." A week ago, I got a phone call from him saying that he's still working on this drug because we're getting slaughtered. You just have to pick up the newspaper and see that it's gone the other way. Yes, the Delta variant is definitely helping us in the U.S.
Ex-U.S., the Delta variant has already been out there. In Brazil and South America, the Brazilian variant is there. South America has been hit extremely hard, we're in those countries that continue to look like we did six months ago, four months ago. On top of that, the Delta variant is coming. We're hearing from sites across the world that they're getting ready for the Delta variant. They're seeing what happened in the United States and happening in the United States. It's taken on an extreme urgency. As I had mentioned before, the way that sabizabulin works is that it works through interrupting microtubules. Microtubules are responsible for pulling the virus from the surface into the nucleus, where the coronavirus can replicate.
Once it makes new viruses, the viruses have to be brought to the outside of the cell and released, and our drug works by interrupting that, again, the microtubules, which are required to, like a highway, to bring the virus to the outside of the cell and release it. We don't care whether it's a blue car or a green car or a bus or a truck. The highway's gone. You're not going to be able to move freely in and out. We're comfortable that we're not going to have an issue like a very specific antibody or a vaccine against the variants. I think that's going to be the major strength of our compound. Whether a Delta variant, a Lambda variant, or some of these other variants that are coming through, it should not matter.
I think that puts us in good footing to, if, again, if we replicate the phase II results, to have an effective broad spectrum type of product.
Got it. Sabizabulin should perform the same among those patients that got COVID-19, regardless whether they are vaccinated or unvaccinated. Is that correct?
In fairness, it's a good question. In fairness, again, we're staying very close to this because we're in the middle of this war, so to speak. If you're vaccinated, you tend to have a more mild outcome. Yes, you're seeing this strange breakthrough. What's happening is that the unvaccinated are the ones that are really bearing the brunt of this particular part of the pandemic. If you're unvaccinated, the Delta variant, you're going to get it, and you're going to get it quickly. Still, it's the same situation, age, comorbidities, and the whole bit. Even though we're hearing that a lot of the young people are starting to show up because they didn't get vaccinated, about half these ICUs are filled with people that are still older age that didn't get vaccinated.
It's going to be plenty of people that we can try to help through our clinical trial, but more importantly, confirm whether our clinical trial is going to replicate what we saw in phase II. That's what I would say about the Delta variant.
Got it. Does this slow down the enrollment for the phase III prostate cancer trial?
No, we have not seen that. Interestingly, and I had made this comment before, that with cancer patients, if you've got cancer, it's metastatic, it's spreading, people are scared. What we did see, the first half when we had the phase I-B and the phase II ongoing, is we did have a few patients that got a little bit nervous about coming into the hospital to get their scans. They were already in the trial and was enrolled, but we got a little delay here and there, and when we actually looked with a CT scan or an MRI. That was more of a rare instance. Most people stayed on track. Now I can tell you that the sabizabulin phase III is open and enrolling, and we're smack on target, if not a little ahead of target in terms of enrollment.
Far, we have not seen that problem. Get back to your point before about COVID-19. There's no question we're getting a lot of inbound interest for sites in the U.S., where before, as I said, it was crickets. Nobody was calling us, nobody was returning our calls, but that's changed dramatically. We're hoping that this will get us to the finish line in terms of enrollment.
Got it. Thank you.
Thank you.
The next question comes from Kumar Raja from Brookline Capital Markets. Please go ahead.
Thanks for taking my questions. With regard to the completion of enrollment by the end of the year for the COVID-19 trial, does that take into consideration the recent uptick in cases? Also in terms of dosing either orally or by the nasogastric route, did you see any difference in efficacy based on how the drug is being administered?
Right. I'm going to answer the second question first. You're asking that with sabizabulin in COVID-19 being a capsule, are we finding some problems administering the drug in an ICU setting?
It looks like they can be either administered orally or using the nasogastric tube. Yeah.
Yes. Exactly. From that standpoint, we have not seen any problem because patients need to get medicines. Because it's a capsule and it's a powder in a capsule, we've had no problem with administering either orally or through an NG tube. That's been fine. As it relates to your question about the uptick and meeting our goals, in other words, we said we'd get this thing filled by year-end, and then it went quiet in the U.S., so I must admit, we were getting nervous because we have to have a certain U.S. component, and it went away. Now we're not nervous anymore because the U.S. has gone I mean, just look at the numbers. It was 108,000 new cases on average daily. The hospitalizations are picking up. Two weeks after, the deaths will start picking up.
It's just, I mean, we've gotten to a point now entering the fourth wave, that we can almost predict what's going to happen. Other than the vaccinated patient, the unvaccinated patient is kind of following the playbook. I would say because of the uptick in cases, that we're more likely to reach our goal.
Okay. With regard to sabizabulin as well as enobosarm, with regard to Europe, what's happening in that front, and also you talked a little bit about pharmaceutical partnerships. How should we think about it? Would it be just partnership for Europe or maybe a little bit of color on that?
Yeah, sure. We're fortunate that we're going to be in a position in both our breast cancer and prostate cancer programs to be in phase III. Because you're in phase III, the question then becomes, how are you viewing partnerships? As you know, the back of the envelope would say that if you piecemeal the relationships, then it will decrease the value of the opportunity for a global partner. What we're trying to do is, first of all, take a step back. Sabizabulin prostate, we're only running in the U.S., and the enobosarm phase III, ARTEST study's being done in the U.S. and Europe. We're also in the process of beginning to have some of the EMA discussions that we will need. As you know, EMA, and with Brexit and everything, we have to understand Britain, so that's gotten a little strange.
Our position right now is to execute on the trial. The trials are open label. Which means that we have a DSMB that can look at this and we can continue to execute. I think the most important thing for us to do is get these things filled, execute on them. We are in constant discussions with large pharma, medium-sized pharma, and small pharma across all our programs. I think the way we're thinking of it, the biggest value that we're going to have as shareholders is to see if we can couple the good phase II data with some good phase III data, or some promise of phase III data, because it's open label. To me, that feels like that's going to get us the best value. We have the resources thanks to our shareholder support, and we have the resources because of our base business.
I think we're in a very unique position that we can wait it out to get the best position, get the best deal. I do believe that at some point, some of our programs are going to be best served with a pharmaceutical relationship, particularly on the commercial side. We're doing exactly as you would expect us to do, and that is having discussions with the largest and the smallest. The largest, not the smallest, the largest and the medium. Largest for global and the medium for piecemealing it. Our preference is to keep the dialogue going till we get an offer we can't refuse.
Thanks so much.
The next question comes from Chris Howerton from Jefferies. Please go ahead.
Hey, good morning. Thanks so much for taking the questions, Mitch. I guess just two for me. First on the FC2. Obviously, great to see the continued growth on that program. I guess I'm curious if you could provide a little color as to what is driving that growth currently, and what is the expectations going into the H2 of the year. Perhaps there's some seasonality to the trends that you might expect for contraception that would be helpful for us to know about. That's one question. The second question, I guess maybe I missed it, but I'm just wondering when we might expect the phase II portion for the ongoing study in prostate cancer. Thank you.
Great. The first question had to do with, can we give you a little bit more color in terms of FC2 growth. I will tell you, there is no seasonality. As you can tell, it's also completely COVID-19 resistant. The growth is being driven by, and this is the beauty of it, we have telemedicine partners that are using their resources to market and sell and bring women seeking birth control to their websites, their storefronts. It's an incredibly powerful way to go out there and market and sell. Because if we look at the number of FTEs that are supporting our U.S. business, it's like three or four. That's generating $30 million-$35 million if you take out global public sector. It's incredibly efficient for a company like ourselves, because then we can use those resources to put back into the company.
With that said, where we see the growth taking place is we're also seeing that there's a very healthy reorder rate with the telemedicine. It's not, yes, it's a big blue ocean and people are starting, but they're coming back. The reorder rate is very healthy. As you know, that will help the numbers from an exponential standpoint. Also, we're in discussions with other telemedicine groups that are focused on birth control. Because this area is growing, new ones are showing up periodically that we've engaged with. Hopefully we'll pick up a few more of those. Every time we pick up a few more of those, that really increases the number of prescriptions that we're able to have. Finally, we're going to look for other ways that we can take advantage of digital and internet channels to sell.
We've been very pleased. The global public sector did fine. It was flat. It was a little bit more than flat. Boy, I think you're going to see all of the growth driven primarily by the U.S. prescription business. The ratios have flipped, where it used to be all public sector and then with a little bit of U.S. prescription. Now from a revenue standpoint, from a profit standpoint, it's all going to be primarily U.S. I'm happy to report, we do believe we're going to have a pretty good year. We're four years into it. We're entering our fifth year of growth. Go look, it just seems to be the same rate. That's very good for us because if we can maintain that, then we're paying for our clinical trials.
We can keep some real cash in the bank and not touch it, so that we can accelerate and stay on track and we can also look at a big pharmaceutical partner and say, "Look, you're not going to wait us out." If you're going to give us a deal, give us the best deal possible. I think it's put us in good position. To give you color, there's no seasonality. COVID-19 is not affecting the growth. We're actively involved in business development to get additional telemedicine groups on board, and we also have a few things that we're doing to also enhance that. The business is growing. I'm happy to report. The second question you asked had to do with the ongoing phase II.
The ongoing phase I-B, it's completed. We still have a couple of patients that are beyond two years. That study is still going on. In the phase II, we still have patients on it. I think what will happen is by year-end, we'll be able to provide more color, because the longer we wait with these patients, the more accurate that we're going to get in terms of understanding the median progression-free survival and some of the other data. The phase III is up and running. Urologists and medical oncologists are excited about the data they have seen so far. We've reported updates. The updates are consistent that the agent has activity in prostate cancer.
That's why we're excited to expand it into triple-negative breast cancer, because the pre-clinical data that we saw in prostate showed that we would have an effect on prostate cancer with no neutropenia neurotoxicity. That played out clinically. Then we also have data in triple-negative breast cancer that it should also translate clinically. It'll be interesting to see how that plays out when we go into our second major indication. I would say look for data for the phase II sabizabulin portion of the prostate cancer study towards the end of the year.
That's great. Okay, thanks, Mitch. I guess, I think we've discussed this in the past, but maybe if I can ask is there any information that you anticipate learning from either the ongoing phase I-B, obviously the longer term follow-up, or within the phase II patients that would any way change your current phase III plans, or do you feel pretty solid about those phase III designs at this point?
I think we feel very solid about the phase III design. I think the reason we're continuing is because if I would've told you that on average, these patients are failing at three months, three and a half months with an alternative androgen receptor targeted agent, and we've got some patients that in the phase I-B 12 months and now heading into two years, you would say that's pretty good. That doesn't change our phase III design. Then the phase II is also providing us information that we use to help the trial design assumptions and understanding the PFS and that kind of stuff. I would say that we've learned what we needed to learn from the phase I-B and the phase II.
That's the reason we went to phase III because we felt at that point there was nothing new we were going to learn, and we just can't take drug away and stop the study, so we have to keep providing drug for the patients that are responding. No, I think we're on firm and solid assumptions for the phase III.
Very good. All right. Thank you very much for taking the questions. Appreciate it.
Chris, I appreciate it.
Again, if you would like to ask a question, please press star then one. To withdraw your questions, press star then two. The next question comes from Alexandra Heller from Oppenheimer. Please go ahead.
Hi. Good morning. Thanks for taking the questions and congrats on the quarter. Can you walk us through how you see VERU-100 fitting into the existing treatment landscape for hormone sensitive prostate cancer, and then also your strategic plans for the asset? Thanks.
For VERU-100, the beauty of this compound is that we were able to sit at the sidelines and watch how the field has evolved over the last 30, 40 years. What we've learned is that nobody wants surgical castration. Medical castration is the way to go. Interestingly, in this current landscape, with these new drugs that are allowing patients to live longer, such as the androgen receptor-targeted agents and some of the chemotherapy and the PARP inhibitors, you're finding out that patients are living longer. In all instances, the base is androgen deprivation therapy. When we went from 18 months, now you could be double or triple that, and they're on ADT the whole time, ADT is truly a chronic therapy. For us to get involved with that, with something that takes advantage of what we've learned.
What have we learned? We learned that the landscape now is at the agonist, such as LUPRON, ELIGARD, and those kinds of medicines, always when you give the injection, you have about 14 days, two weeks of high levels of testosterone that then come down, and the castration levels are not as ideal. Yet, that's what we had, and it worked. Then the antagonist came along, and they shut off testosterone right away, and the patient gets castrated right away. It turns out that it also lowers FSH, which is thought to be important for cardiovascular events. LUPRON, if you've had LUPRON type drug, and in my event showed this in their study, that if you had a cardiovascular event and you were put on leuprolide, you have a one in five chance of having another one. It's pretty high.
I would argue that if the GnRH antagonist was discovered first, that Lupron and the agonist probably would never have been approved. I think this field is definitely moving to GnRH antagonists. In the flavors of GnRH antagonists, now the second challenge is how do you become part of the medical care standard versus how do you disrupt the medical care standard. The standard of care right now is the patient comes in every three to four months to get imaging and to see their doctor, and to come in every month doesn't make sense. We know that because degarelix was a one-month GnRH antagonist depo, and it did not do well. It didn't do well because it was not a good drug. People were kind of using it to castrate the patient right away then add Lupron.
People were worried about it, the problem is it didn't fit the standard of care. The three and four-month depots for LUPRON and ELIGARD are the standard of care. If you had a GnRH antagonist that was a three or four-month depot, you could be easily substitutable and become the preferred choice. At the end of the day, compliance is really kind of important for this agent. The reason compliance is important for this agent is because you don't feel well when you get castrated. You lose your libido, you develop change in body composition with fat and diabetes and loss of muscle mass and gynecomastia and hot flashes. They're constantly looking for a way to get a drug holiday.
If they were in control, if the patient was in control with their own castration, then they may not be as compliant because they want that weekend break, or they want to feel good when their kids are there or whatever. Testosterone pops back up, it's going to cause the tumor to spread, and then the patient's going to have to get onto more expensive drugs like the androgen receptor-targeted agents and IV chemo. We think the strategy for us is that when the patient first develops advanced disease, metastatic prostate cancer that's hormone sensitive, that the foundation, the drug that you start with should be our drug, should be VERU-100.
Because it's given every three months, potentially could be given every three months, it would not buck the standard of care, doctors would be comfortable providing it, knowing the patient will come back at the same time that they would usually see the patient and the same time they would usually image the patient. You're not changing standard of care. The urologist and the physician gets paid because they administer the medicine, and they also get a percentage of the product based on the AWP, that doesn't change. Our strategy and compliance is critical. Now, the other thing that's changed also is that the data shows that it's unusual for a patient to get ADT monotherapy today. If somebody comes in with hormone-sensitive disease, they almost certainly can have it coupled with some of these other medicines.
That's yet another reason why you want to try to decrease the pill load and other things that the patient is taking and make it simple that there's one less thing they have to worry about every day. I do think it's going to be very interesting. The other thing, and then I'll be quiet, is strategically, the worldwide market for ADT, androgen deprivation therapy, is about $2.6 billion, and that's based on pricing for leuprolide. GnRH antagonists are not priced like a generic leuprolide, and so the market is probably double, if not triple that. We just don't need to get much of that market to really move the needle. This is a really attractive option and a real attractive product for us.
Basically, the way we would think of this product is this is the kind of product we could have regional partners in Europe, Asia, and maybe hold onto the U.S. ourselves, because it's the foundation. That's where you're going to go in and call on the urologist and medical oncologist about prostate cancer. As you know, we have sabizabulin for patients that fail ADT, and an androgen receptor-targeted agent would make a lot of sense. That's how we're thinking about it, Alex.
Perfect. Thank you. That was super helpful. Really appreciate it, Mitch.
Thanks.
Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference call back over to Dr. Mitchell Steiner for any closing remarks.
I appreciate you all joining us on today's call, and I look forward to updating all of you on our progress in our next investors call. Thank you for joining us today.
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