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, regulatory interactions, 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 as well as in our press releases from time to time. I would now like to turn the conference call over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO and President.

Good morning. With me on this morning's call are Dr. Gary Barnette, the Chief Scientific Officer; Michele Greco, the Chief Financial Officer and Chief Administrative Officer; Michael Purvis, Executive Vice President and General Counsel of Corporate Strategy; and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of advanced breast cancer and for acute respiratory distress syndrome related to viral lung infections. Our drug development program includes enobosarm as a directive antigen receptor agonist for the treatment of second-line hormone receptor-positive HER2-negative metastatic breast cancer and sabizabulin, a microtubular disruptor for the treatment of severe COVID-19 and other types of viral-related ARDS. The company also has an FDA-approved commercial product, the FC2 Female Condom, an internal condom, providing dual protection against unplanned pregnancy and sexually transmitted infections. The revenue from the sexual health program is being used to partially fund the clinical development of our late-stage therapeutic candidates, which aim to address multibillion-dollar market opportunities. We've had a very busy and productive third quarter of fiscal year 2023. This morning, we will provide an update on the clinical development of breast cancer and viral ARDS drug candidates as well as the good progress on the commercialization of our FC2 product. We'll also provide financial highlights for our third quarter fiscal year 2023. Now regarding our oncology program, the company's oncology drug pipeline is focused on the clinical development of enobosarm for the treatment of metastatic breast cancer. Enobosarm is a different and new class of endocrine therapy for advanced breast cancer. Enobosarm is an oral new chemical entity, a selective androgen receptor agonist that activates the androgen receptor in androgen receptor-positive, estrogen receptor-positive HER2-negative metastatic breast cancer to suppress tumor growth without the unwanted masculinizing side effects and increases commonly seen with androgens. Enobosarm has extensive nonclinical and clinical experience, having been evaluated in 25 separate clinical studies with approximately 1,450 subjects dosed, including 3 Phase II clinical studies in advanced breast cancer involving more than 250 patients. In the 2 Phase II clinical studies conducted in women with androgen receptor-positive ER-positive HER2-negative metastatic breast cancer, enobosarm demonstrated significant antitumor efficacy in heavily pre-treated cohorts that failed estrogen blocking agents, chemotherapy, and the CDK4/6 inhibitors, and it was well tolerated with a very favorable safety profile. The current standard of care for first-line treatment of ER-positive HER2-negative metastatic breast cancer is treatment with a CDK4/6 inhibitor in combination with an estrogen blocking agent once the patient progresses while receiving this combination therapy, and if there are no specific genetic mutations detected, the FDA-approved treatment choices are limited to either another estrogen blocking agent or chemotherapy. As up to 90% of ER-positive HER2-negative metastatic breast cancers also have the androgen receptor, we're developing enobosarm, a selective androgen receptor targeting agent as another different hormone therapy for second-line treatment of ER-positive HER2-negative metastatic breast cancer. In preclinical studies, metastatic breast cancer tissue samples taken from patients who have ER-positive/HER2-negative metastatic breast cancer that have become resistant to CDK4/6 inhibitors and estrogen blocking agents were grown in mice. In these mice, treatment with enobosarm in combination with a CDK4/6 inhibitor suppressed the growth of the human metastatic breast cancer more than the CDK4/6 inhibitor alone. Interestingly, the CDK4/6 inhibitor treatment caused the metastatic breast cancer tissue to produce higher amounts of androgen receptor, which may explain the synergy of combining CDK4/6 inhibitors with enobosarm, a selective androgen receptor agonist. Further, enobosarm treatment alone was also effective in suppressing the growth of CDK4/6 inhibitor in estrogen-blocking human metastatic breast cancer tumors in mice. We're conducting a Phase III clinical ENABLAR-2 study, with enobosarm monotherapy or in combination with abemaciclib, which is a CDK4/6 inhibitor versus an estrogen-blocking agent, which is the active control, as a second-line treatment for AR+/ER+/HER2- metastatic breast cancer. On March 30, 2023, the company met with the FDA to gain further agreement on our Phase III clinical trial design and program. The Phase III study has been amended to accommodate the FDA's latest recommendations to support the registration of enobosarm as a second-line treatment for patients with AR+/ER+/HER2- metastatic breast cancer to tumor progression while receiving a CDK4/6 inhibitor plus an estrogen-blocking agent, in other words, first line. The Phase III ENABLAR-2 study has 2 stages. In Stage 1 of the Phase III study, the objectives are to optimize the dose of enobosarm in combination with abemaciclib and to assess the efficacy of enobosarm as a monotherapy. In the clinical trial design of Stage 1, we will enroll 160 patients into 5 treatment arms of 32 patients each. The arms are as follows: estrogen blocking agent, which is the active control, abemaciclib plus enobosarm 9-milligram combination therapy, abemaciclib plus enobosarm 3-milligram combination therapy, abemaciclib plus enobosarm 1-milligram combination therapy and enobosarm 9-milligram monotherapy. The primary endpoint for Stage 1 is objective tumor response rates, also referred to as ORR. We are currently producing clinical supply of 1-milligram or 3-milligram enobosarm capsules for the additional dose optimization arms, which are expected to be available early next quarter. The Stage 1 initial run-in enrolled 3 patients to assess the safety and pharmacokinetics of the abemaciclib plus enobosarm 9-milligram combination. In this run-in portion, there were no drug-drug interactions between abemaciclib and enobosarm and no new safety findings. Further, the early preliminary clinical results show 2 partial responses and 1 stable disease in the first 3 patients based on local assessments, and all patients are or were on study for over 9 months. By way of reference, the objective tumor response rates are about 4% for the estrogen-blocking agent alone in similar patients as reported in the scientific literature. In Stage 2 of the Phase III study, we plan to enroll approximately 200 subjects in a multicenter open-label randomized 1:1 active control clinical study to evaluate the efficacy and safety of enobosarm with and without abemaciclib therapy depending on the outcome of the first stage in subjects with AR+/HER2- breast cancer who have progressed while receiving a CDK4/6 inhibitor plus an estrogen-blocking agent, again, the first line. The primary endpoint for Stage 2 of the Phase III study is progression-free survival. Our current plan is to have the Phase III stage 1 clinical results by late 2024 or early 2025. If enobosarm monotherapy or the abemaciclib plus enobosarm combination therapy compared to an estrogen-blocking agent, which is the active control, demonstrates significant improvement in ORR, which is considered as a surrogate endpoint for clinical benefit, then the company plans to meet with the FDA to consider an accelerated approval regulatory pathway based on the clinical data from the Stage 1 portion of the Phase III study. The Stage 2 portion of the Phase III clinical study will serve as the confirmatory study with progression-free survival as the primary endpoint. In January 2022, Veru entered into a clinical trial collaboration and supply agreement to which Eli Lilly supplies abemaciclib for the ENABLAR-2 Phase III clinical trial. Now let's turn to our viral ARDS infectious disease program. The company is developing sabizabulin 9 milligrams, which is both a host-targeted antiviral and has broad anti-inflammatory properties as a two-pronged approach to the treatment of hospitalized patients with viral lung infections and a high risk for ARDS and death. The company has completed positive Phase II and positive Phase III COVID-19 clinical studies that have demonstrated that sabizabulin treatment resulted in a significant mortality benefit in hospitalized moderate to severe patients with COVID-19 viral lung infections at high risk for ARDS. As viruses that cause lung infections and ARDS do so in a similar way, the company believes that sabizabulin has the potential to be a treatment for all types of viral-induced lung infections, not only SARS-CoV-2 but also influenza A or B, respiratory syncytial virus, also known as RSV and other viruses in hospitalized patients on oxygen with high-risk ARDS. We plan to meet with the FDA in September to expand the patient population of the agreed-upon Phase III confirmatory COVID-19 study into a Phase III study to treat hospitalized adult patients who have any kind of viral lung infection who are on oxygen support and at risk for ARDS. The way to think of it is COVID-19 represents one of many respiratory viruses that cause lung infections, pneumonia, which may progress to ARDS and death for which we've already conducted a successful Phase III study demonstrating a mortality benefit with sabizabulin treatment. The Phase III was a double-blind randomized placebo-controlled study in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS. The primary endpoint was the proportion of patients that died by day 60. Based on the planned interim analysis of the first 150 patients randomized, the independent data monitoring committee unanimously recommended that the study be stopped for clear evidence of clinical benefit, and they identified no safety concerns. In the interim analysis, treatment with sabizabulin 9 milligrams once daily resulted in a clinically meaningful and statistically significant 55.2% relative reduction in deaths compared to placebo. On May 10, 2022, the company had a pre-emergency use authorization meeting with the FDA to discuss the submission of an EUA application for sabizabulin COVID-19 treatment. On June 7, 2022, at the request of the FDA, the company submitted a request for FDA emergency use authorization for sabizabulin for adult hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. On February 28, 2023, the FDA notified the company that it had declined to grant the company's request for emergency use authorization. In communicating its decision, the FDA stated that despite the FDA declining to issue an EUA for sabizabulin at this time, the FDA remains committed to working with the company in the development of sabizabulin. Separately, at the FDA's Advisory Committee meeting, the FDA's statistical efficacy summary of our Phase III clinical study was presented and indicated that the study met the statistical criterion for stopping at the interim analysis. Data in all 204 subjects completing the study indicated treatment benefit for all-cause mortality at day 60. Results were robust to missing data assumptions. Exploratory analysis indicated minimal impact of baseline imbalances and timing of enrollment with the duration of standard of care, and it demonstrated a positive numerical trend consistent across subgroups defined by age, baseline WHO category, region, and standard of care use at baseline. On April 27, 2023, the company met with the FDA and reached agreement on the design of the Phase III confirmatory COVID-19 clinical trial to evaluate sabizabulin treatment of hospitalized moderate to severe COVID-19 patients who are at risk for ARDS, as well as the path forward to submit a new EUA application or an NDA. The FDA agreed to a confirmatory Phase III randomized placebo-controlled study to evaluate sabizabulin 9 milligrams oral daily dose plus standard of care versus placebo plus standard of care in 408 hospitalized adult patients with moderate to severe SARS-CoV-2 infection at high risk for ARDS. The indication, in other words, the patient population for sabizabulin will also be expanded to include all hospitalized moderate to severe COVID-19 patients. The primary efficacy endpoint will be all-cause mortality at day 60. Secondary endpoints include days in the hospital, days in the ICU, days on mechanical ventilation, the proportion of patients alive without respiratory failure, and an exploratory endpoint, which is the presence of long COVID-19 symptoms at day 180. In order to get a potentially efficacious drug to patients in an efficient time frame, 2 planned interim efficacy analyses will be conducted. The first planned interim analysis is expected to occur when 204 patients, which is 50% of the population have completed the day 60 primary efficacy endpoint. The second planned interim analysis is expected to occur when 290 patients, or 71% of the patient population, have completed the day 60 primary efficacy endpoint. If either of the interim efficacy analyses meet the statistical significance criteria, the trial could be stopped for efficacy. Should the prespecified primary efficacy endpoint analysis demonstrate a statistically significant effect on all-cause mortality favoring sabizabulin, the company may consider a new request for an EUA or a submission of an NDA, as the company would potentially have 2 adequate and well-controlled trials to review. As the program has fast track designation, a rolling NDA submission is a possibility for sabizabulin. Now, sabizabulin does have activity against influenza. So on April 4, 2023, the company announced results from a preclinical study of sabizabulin demonstrating robust anti-inflammatory activity with improved outcomes in the H1N1 influenza-induced pulmonary inflammation mouse ARDS model. Sabizabulin treatment resulted in a statistically significant decrease in the total number of inflammatory cells and a reduction in key cytokines and chemokines in lung fluid. Clinically, sabizabulin treatment resulted in a reduction in severity of lung inflammation by histopathology and a dose-dependent improvement in lung function. As for our case, we're expanding the indication to all types of viral lung infections related to ARDS. Viruses cause up to 1/3 of community-acquired pneumonia, and viral infections can trigger the immune system to release an overwhelming amount of inflammatory proteins known as a cytokine storm. Cytokine storm causes tissue damage in the lungs that lead to ARDS, and patients who develop ARDS have a high mortality rate. As ARDS results from the exaggerated immune inflammatory responses to the viral infection rather than from direct injury by the virus itself, an antiviral agent alone may not be effective. Sabizabulin, being a host-targeted antiviral and a broad-spectrum anti-inflammatory agent, has the potential to address both the viral infection and the inflammation caused by the cytokine storm that leads to ARDS, multi-organ failure, and death. We are currently in the midst of a summer surge for COVID-19, and another surge is expected in the fall and winter. In the current endemic phase, COVID-19 infection is estimated to be the fourth leading cause of death in the United States in 2023. ARDS remains a frequent serious complication of severe COVID-19 infection. It has been reported that up to 33% of hospitalized COVID-19 patients have ARDS, and 75% to 92% of patients admitted to the intensive care unit with COVID-19 have ARDS. The mortality rate of COVID-19-associated ARDS is 45%, and among the patients who died from COVID-19, there is a 90% incidence of ARDS. As the COVID-19 endemic continues, there's also a need to remain vigilant and focused on preparedness for the next wave of infections involving new viral strains. COVID-19 will be a problem for the foreseeable future, and there's a need for effective therapies, especially for these hospitalized patients with moderate to severe COVID-19 infection at high risk for ARDS. Further, the influenza burden estimates according to the Centers for Disease Control and Prevention in the United States was up to 630,000 hospitalizations and up to 55,000 deaths in the past 9 months. RSV was responsible for 177,000 hospitalizations and 14,000 deaths among adults aged 65 and older in the United States. Interestingly, the pathogenesis and mortality rates for hospitalized influenza and RSV adult patients who have viral lung infections and who develop ARDS are similar to COVID-19-associated ARDS. Patients with viral lung infections who are on oxygen support and at risk for ARDS represent a high unmet need and a potentially large market opportunity with very limited treatment options. Viral-induced pneumonia and lung infection is the leading cause of hospitalization in the U.S. according to the American Thoracic Society. So although we have reached an agreement with the FDA for the design of the Phase III confirmatory COVID-19 clinical trial, we believe that given the changing COVID-19 landscape, the need for an agent like sabizabulin that has the potential to provide a mortality benefit in all types of viral lung infections that could lead to ARDS and death, and the serious unmet medical need caused by viral lung infections and ARDS, the company now plans to meet with the FDA again to reach an agreement on the design of the proposed expanded Phase III confirmatory study evaluating sabizabulin 9 milligrams for the treatment of hospitalized adult patients who have viral lung infections on oxygen and are at high risk for ARDS and death regardless of the type of virus. The FDA has granted a meeting with Veru in September 2023. We will provide an update on the viral lung infection ARDS program after we meet with the FDA and gain appropriate clarity on this proposed study. If we reach an agreement with the FDA, we will not pursue the Phase III confirmatory COVID-19-only study or the influenza A or B-only study. The clinical precedent that informs us of our potential change in regulatory and clinical strategy was set by AstraZeneca, which has begun enrolling a Phase III efficacy and safety study for tozorakimab in hospitalized patients receiving standard of care for all types of viral lung infections requiring supplemental oxygen, as listed in the clinicaltrials.gov under NCT0562-4450. The primary endpoint is the proportion of patients that die or progress to invasive mechanical ventilation by day 30. Tozorakimab is an anti-inflammatory anti-IL-33 antibody that inhibits the IL family of cytokines. Interestingly, in hospitalized COVID-19 patients on supplemental oxygen, similar anti-inflammatory antibody treatments had an absolute reduction in mortality of less than 5%. In our Phase III COVID-19 study, which included patients on mechanical ventilation, treatment with sabizabulin as a dual antiviral and broad anti-inflammatory agent resulted in a 20% absolute reduction in mortality. In April, we submitted a request to the FDA to reevaluate the FDA's declination of our EUA for sabizabulin through the FDA's formal dispute resolution process. The FDA denied our request for entry into the process, stating that they are committed to working with us on sabizabulin. They have recommended that we continue with our current clinical plan and reach out to the FDA as often as needed under the Fast Track designation that supports sabizabulin's development. Interestingly, in another development, the influenza and emerging infectious disease division of the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services is planning a large multicenter clinical trial in hospitalized adult patients with ARDS. BARDA states, 'This clinical trial will evaluate the safety and efficacy of novel threat-agnostic and host-directed therapeutics that can address ARDS caused by known and unknown health security threats such as pandemic influenza, COVID-19, and other emerging infectious diseases.' Veru was selected as one of the finalists and presented as a visible candidate to BARDA as a novel threat-agnostic and host-directed therapeutic agent with broad anti-inflammatory activities in hospitalized adult patients at high risk for ARDS. The ARDS Therapeutics pitch event was called Just Breathe, conducted at the end of July 2023. We expect to be notified of the decision in early Q4 2023. BARDA plans to select up to 3 therapeutic candidates representing different mechanisms of action versus placebo for participation in the planned BARDA-sponsored ARDS clinical study, which would consist of 200 subjects per arm. As you know, we're pursuing treatment options for smallpox and the ebolavirus, along with other viral infections that may also lead to ARDS and death, as these represent a global public health threat. On April 11, 2023, Veru announced positive results in a preclinical in vitro study conducted by a team of researchers led by Dr. Brian Ward, Associate Professor of Microbiology and Immunology at the University of Rochester in New York. The preclinical study evaluated the effects of sabizabulin against the prototypical poxvirus called vaccinia virus, demonstrating that sabizabulin prevented both the release of the poxvirus from infected cells and the spread of the poxvirus to healthy cells. Sabizabulin, as a host-directed antiviral and broad anti-inflammatory agent, may be useful as a novel treatment not only against smallpox and other pox viruses, but may also reduce the hyperreactive immune response triggered by poxvirus that is responsible for severe pneumonia, ARDS, multi-organ failure, and death. The company has a scheduled pre-IND meeting with the FDA this month to discuss the animal rule regulatory requirements for assessing the efficacy of sabizabulin for the smallpox virus. As you know, clinical human efficacy trials of drugs for preventing or treating the smallpox virus are not feasible, and challenge studies are considered unethical. Therefore, drugs with these indications are generally developed and approved via a regulatory pathway commonly referred to as the animal rule. The FDA may grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans. Now I'd like to turn to our commercial business. The company sells FC2 in both the U.S. commercial sector and in the public health sector in the United States and globally. As the only FDA-approved female internal condom in the United States, FC2 is a well-established and significant business. We have sold over 750 million female condoms worldwide, and since 2017, FC2 has generated over $213 million of net revenue. We have and we plan to continue to invest the profits from the FC2 business to help fund the clinical development of our drug candidates enobosarm and sabizabulin. The telehealth channel has become an important commercial strategy in the United States for access to birth control products, especially for our product FC2, which is a non-hormonal and latex-free option to prevent pregnancy and transmission of sexually transmitted infections. In a recent survey of 6,000 respondents conducted by the Kaiser Family Foundation, 82% of respondents said that the COVID-19 pandemic was not the reason they first accessed birth control online, which supports our strategy to provide contraceptive access using the telehealth portal. In the same survey, almost 5% of women reported getting the FC2 female condom, which was actually the third most prescribed contraceptive behind pills and emergency contraception. As a point of reference, we believe this is good news about the potential commercial opportunity for FC2 in the United States contraceptive market. If the 5% market share shown in the survey can be extrapolated to the estimated $8.3 billion contraceptive market in 2022, with projections to grow at a compound annual growth rate of approximately 5.1%, there is potentially a $400 million market opportunity for FC2. Accordingly, to have more direct control over promotion and distribution to maximize U.S. prescription sales of FC2, the company made a decision last year to launch its own independent FC2 dedicated direct-to-patient telehealth contraceptive portal. The company continues to invest in and grow its direct-to-patient telemedicine portal as well as adding new telehealth and internet fulfilling pharmacy partners so we can provide coverage in all 50 states in the United States. Having taken the time to refine our marketing, drive operational improvements and enhance the patient experience during the initial launch phase, we are increasing new prescriptions being written and filled through our FC2 telehealth portal. During the third quarter of fiscal year 2023, we saw our new prescriptions grow over 115%, providing prescriptions to approximately 4,400 patients. We believe these results support our strategy and demonstrate high demand for FC2. We plan to continue to grow and deepen our investment in a profitable way by further expanding our presence both in social media channels and online searches. Now in the U.S. public sector, the company has seen a 115% increase in volume in the third quarter of fiscal year 2023 compared to the third quarter of fiscal year 2022. The growth is attributable to key U.S. public sector partnerships, including the company's recent announcement in April 2023 that it has entered into a purchasing agreement with Afaxys Group Services, the #1 provider of oral and emergency contraceptives in U.S. clinics. In the global public health sector outside the U.S., the company markets FC2 to entities including ministries of health, government health agencies, UN agencies, not-for-profit agencies, and commercial partners. We are currently supplying a large multiyear South African tender for female condoms, which is expected to continue until 2025, and we have seen sales grow in the current year as the current tender is launched. We also expect a formal Brazil tender process to commence later this year. Based on our experience to date, we expect revenue from our U.S. FC2 prescription business will demonstrate robust growth, both from our dedicated FC2 telehealth portal and the addition of new telehealth and other commercial distribution partnerships. Furthermore, we intend to continue to leverage partnerships with entities in the U.S. public sector, such as state departments of health and 501(c)(3) organizations, which generated strong unit sales growth we have seen in fiscal 2023 from this channel. Now the company had another FDA-approved product called Entadfi, which is a new treatment for BPH that was approved by the FDA in December 2021. The product supports the company's sexual health program. On April 19, 2023, the company entered into an asset purchase agreement with Bluewater Vaccines to sell substantially all of the assets related to Entadfi. The transaction closed on April 19, 2023, and the purchase price for the transaction was $20 million plus $80 million in future sales milestones. I will now turn the call over to Michele Greco, CFO and COO, to discuss the financial highlights. Michele?

Thank you, Dr. Steiner. As Dr. Steiner indicated, we have a lot of activity at Veru. Let's start our highlights with the third quarter results for the 3 months ended June 30, 2023. Overall, net revenues were $3.3 million compared to $9.6 million in the prior year third quarter. The prescription business net revenues decreased from $6.7 million in the prior year third quarter to $863,000. The reduction in the prescription business net revenues is due to not having any revenues from the Pill Club in the current period due to the Pill Club's Chapter 11 bankruptcy filing. Global public sector net revenues were $2.5 million compared to $2.9 million in the prior year third quarter. Gross profit was $1.2 million or 37% of net revenues compared to $7.1 million or 74% of net revenues in the prior year third quarter. The reduction in gross profit and gross margin is driven primarily by the change in the sales mix with our U.S. FC2 prescription business representing 26% of net revenues in the current period compared to 70% in the prior period. Operating expenses for the quarter decreased to $13.8 million from the prior year's quarter of $28.9 million. The decrease of $15.1 million is primarily due to research and development costs, which decreased $15.2 million to $2.9 million compared to $18.1 million in the prior year quarter but is offset by a small increase in selling, general, and administrative expenses of approximately $100,000 from $10.8 million to $10.9 million in the current period. The decrease in research and development costs is primarily due to the company's recently announced updated strategy to refocus its development efforts on drug candidates with the best opportunity to lead to long-term success and to create value for the shareholder. On April 19, we sold our Entadfi product to Bluewater Biotech for $20 million. We received $6 million at closing and promissory notes of $4 million payable by September 2023, $5 million payable by April 2024, and $5 million payable by September 2024. In addition, there is the possibility of up to $80 million in sales milestone payments. We recorded a $17.5 million pretax gain on the sale of Entadfi. Operating income for the quarter was $4.9 million compared to an operating loss of $21.8 million in the prior year quarter. The change of $26.7 million is due to the pretax gain on the sale of Entadfi of $17.5 million, plus the reduction in operating expenses of $15.1 million, offset by the reduction in the gross profit of $5.8 million. Nonoperating income was $1.5 million compared to nonoperating expense of $234,000 in the prior year third quarter and primarily consisted of the change in the fair value of the derivative liabilities related to the synthetic royalty financing, partially offset by interest expense. The change of $1.7 million is primarily due to a reduction in interest expense of $536,000 and an increase in the change in the fair value of the derivative liability of $908,000. For the quarter, we recorded a tax expense of $58,000 compared to $138,000 in the prior year third quarter. The bottom line results for the third quarter of fiscal 2023 show net income of $6.3 million or $0.07 per diluted common share compared to a net loss of $22.2 million or $0.28 per diluted common share in the prior year third quarter. Turning to the results for the 9 months ended June 30, 2023, total net revenues were $12.4 million compared to $36.8 million in the prior year period. Net revenues from the U.S. prescription business were $5.2 million compared to $29.9 million in the prior year period, and net revenues from the global public health sector business were $7.2 million compared to $6.9 million in the prior year period. The reduction in the U.S. prescription business net revenues is primarily due to lower volumes from telemedicine customers because of ongoing challenges, which included changes in strategy, the impact of rebranding, and reduction in marketing spending, resulting in a slowdown in orders during recent quarters. Net revenues from the Pill Club were $3.9 million in the current year period compared to $17.4 million in the prior year period. We recorded a provision for credit losses for the net revenues during the current year period, which were included in the gross accounts receivable balance on June 30, 2023, due to the Pill Club Chapter 11 bankruptcy filing. Net revenues from another prescription channel customer were $11.3 million in the prior year period and 0 in the current year period, attributable to inventory management after a reduction in orders from its most significant customer, which discontinued its operations, resulting in our customers ceasing orders. We're working to increase net revenues in future periods by growing awareness and driving demand through increased marketing efforts for FC2 via our telehealth platform and through discussions with potential new distribution partners in the telehealth sector. The increase in FC2 net revenues in the global public health sector is due to shipments commencing for orders under the 2022 South Africa tender in the current year period, as well as increases in U.S. public sector orders. Overall, gross profit was $6 million or 48% of net revenues compared to $30.1 million or 82% of net revenues in the prior year period. The decrease in gross profit and gross margin is due primarily to the change in sales mix with the U.S. prescription business, which has a higher profit margin, comprising a smaller percentage of total net revenues and higher production costs per unit due to lower production volumes. Operating expenses increased by $25 million to $93.6 million compared to the prior year period of $68.6 million. The increase is primarily driven by selling, general, and administrative costs, which increased by $16.4 million to $41.3 million from $24.9 million in the prior year period. The increase in selling, general, and administrative costs is due to commercialization costs of $12.9 million related to preparations for the potential launch of sabizabulin for COVID-19 incurred during fiscal 2023 prior to the FDA's declination decision on our EUA application and an increase in share-based compensation costs to $10.2 million from $5 million, resulting from an increase in the number of unvested stock options for which we recognize expense over a 3-year period. Research and development expenses increased to $44.5 million from $43.8 million in the prior year period. The increased research and development expenses in the second half of fiscal 2022 and the first half of fiscal 2023 were mainly related to sabizabulin for COVID-19 in our emergency use authorization application. In the third quarter of fiscal 2023, due to our updated drug development strategy, we have seen a decrease in research and development expenses. We recorded a provision for credit losses of $3.9 million during the period related to the total receivables due from the Pill Club due to the uncertainty of their financial condition, with no such provision for credit losses in the prior period. During the period, we also recorded an impairment charge of $3.9 million related to in-process research and development assets recorded for sabizabulin for prostate cancer and zuclomiphene based on our updated drug development strategy, with no such impairment charge recorded in the prior period. We recorded a pretax gain of $17.5 million on the sale of assets during the period. The operating loss for the period was $70.1 million compared to $38.6 million in the prior year period. The increase of $31.6 million is primarily due to increased selling, general and administrative expenses, the write-off of intangible assets, the credit loss provision for the Pill Club, all offset by the pretax gain on the sale of Entadfi. Nonoperating income was $749,000 compared to a nonoperating loss of $4 million in the prior year period, primarily attributed to interest expense and changes in the fair value of derivative liabilities related to synthetic royalty financing. This change of $4.7 million is primarily due to a reduction in interest expense of $1.3 million and an increase in the fair value of the derivative liability of $2.9 million. For the 9-month period, we recorded a tax benefit of $77,000 compared to a tax expense of $225,000 in the prior year period. The company has net operating loss carryforwards for U.S. federal tax purposes of $112.7 million, with $29.7 million expiring in years through 2042 and $82.9 million that can be carried forward indefinitely. Our U.K. subsidiary has net operating loss carryforwards of $63.1 million that do not expire. The bottom line results for the first 9 months of fiscal 2023 show a net loss of $69.3 million or $0.83 per diluted common share compared to a net loss of $42.8 million or $0.53 per diluted common share in the prior period. Now let's look at our balance sheet. As of June 30, 2023, our cash balance was $16.2 million. Our accounts receivable balance was $5.1 million and our gross promissory notes receivable from the sale of Entadfi were $14 million. Our net working capital was $15.5 million on June 30, 2023, compared to $63.3 million on September 30, 2022. During the 9 months ended June 30, we used cash of $78.5 million for operating activities compared to $26.6 million for operating activities in the prior year period. On April 19, we entered into an asset purchase agreement to sell our Entadfi assets to Bluewater Biotech for $20 million. We received $6 million at closing, $4 million payable by September 2023, $5 million payable by April 2024, and $5 million payable by September 2024. Additionally, there is the possibility of up to $80 million in sales milestone payments. On May 2, we entered into a common stock purchase agreement with Lincoln Park Capital Fund, LLC, which provides the company with the right, but not the obligation, to sell to Lincoln Park up to $100 million of shares of the company's stock over a 36-month time period. On May 12, 2023, we entered into an open market sales agreement with Jefferies LLC, a sales agent, which provides the company the opportunity to issue and sell through Jefferies shares of our common stock with an aggregate value of up to $75 million. We are not obligated to sell any shares of the company's stock under the Jefferies sales agreement. Jefferies will use commercially reasonable efforts, consistent with its normal trading and sales practices, to sell shares of common stock from time to time based on our instructions, including any price, timing, or size limits specified by us. On July 24, 2023, we had a special meeting in which the company's shareholders approved an increase in the number of authorized shares of common stock from 154 million to 308 million. We are working to increase future FC2 net revenues in the U.S. prescription channel by growing awareness and driving demand through increased marketing efforts for our telehealth platform, as well as pursuing additional distributors in the telehealth sector. We have started to see an increase in the U.S. public sector as a result of new distribution agreements executed within the last year and are beginning to see increases in our global public sector business from under tender while expecting to learn about a new tender in Brazil later in the calendar year. Over the years, we have gained ample experience in managing our cash burn, and one of the effective tools we can employ, if needed, is to slow down drug development or focus on one drug program at a time to match drug development spending with available resources. We believe the current cash balance, along with the projected revenue from sales of FC2 and cash payments expected from the sale of our Entadfi assets, along with our ability to secure financing, will be adequate to fund the planned operations of the company for the next 12 months as we continue to focus on developing novel medicines for the treatment of metastatic breast cancer and for viral-induced acute respiratory distress syndrome diseases. Now I'd like to turn the call back to Dr. Steiner. Dr. Steiner?

Thank you, Michele. The key takeaways from this past quarter are, we have focused on obtaining regulatory clarity on 2 major Phase III clinical trials, and we've received FDA clarity for the Phase III ENABLAR-2 study, evaluating enobosarm monotherapy, enobosarm plus abemaciclib combination therapy versus an estrogen-blocking agent active control as second-line treatment for hormone receptor HER2- metastatic breast cancer. If the Stage 1 portion of the Phase III demonstrates significant improvement in ORR, the primary endpoint by either enobosarm alone or in combination with abemaciclib, then we'll meet with the FDA for a potential accelerated approval pathway. We will also quickly initiate the Stage 2 confirmatory portion of the Phase III study with progression-free survival as the primary endpoint. Remember, enobosarm is a new and different hormone agent that targets androgen receptor-positive metastatic breast cancer with potential improvements in quality of life without the unwanted side effects and increases typically associated with androgens. Given the current COVID-19 landscape and the large unmet medical need for a treatment available with a potential mortality benefit against all types of viral-induced ARDS, the company will meet with the FDA in September to gain agreement to expand the evaluation of sabizabulin beyond COVID-19 into a Phase III confirmatory study that would include all types of viral-induced lung infections, including influenza, RSV, COVID-19, and other viruses in hospitalized patients requiring supplemental oxygen who are at risk for ARDS. This expanded Phase III study would help us with more certainty in the timing of patient enrollment and offers a larger market opportunity. The influenza and emerging infectious disease division of BARDA is planning a large multicenter placebo-controlled clinical trial to evaluate the safety and efficacy of 3 novel threat-agnostic and host-directed therapeutics in hospitalized adult patients with ARDS. Veru has been selected as one of the finalists, and we expect to be notified about the decision during calendar Q4 2023. The company has reported positive preclinical data for sabizabulin, both in treating influenza A-induced ARDS and for poxvirus, and an FDA pre-IND meeting for smallpox virus is scheduled for August of 2023. Financially, we have successfully reduced expenses after we received the COVID-19 EUA declination. The company's cash burn during this quarter was $7.3 million, a $16.1 million reduction compared to the prior quarter. Our cash position in fiscal year Q3 2023 was approximately $16 million, plus we expect $14 million in gross promissory notes receivable from the sale of Entadfi for fiscal years 2023 and 2024, which totals about $30 million. And we expect to continue to receive cash contributions from our FC2 commercial sexual health business. Furthermore, Veru has entered into a common stock purchase agreement with an option to purchase up to $100 million in stock with Lincoln Park Capital Fund. We believe this commitment further enhances our financial flexibility and aligns with our long-term strategy for shareholder value creation. Finally, we are actively seeking, and in some cases already in discussions for potential partnerships with enobosarm for breast cancer and sabizabulin for viral-induced ARDS as another source of non-dilutive capital. With that, I will now open the call to questions. Operator?

Our first question comes from Dennis Ding with Jefferies.

This is Anthea on behalf of Dennis. Two questions from us, if I may. First one on cash, how much flexibility do you have on OpEx to potentially extend the run rate beyond your guidance of 12 months? And second, on breast cancer, can you comment on the status of the mono trial and if we will see data from that?

So a question about cash. I'm going to ask Michele to answer that question, please.

Sure. The question about extending beyond a 12-month runway, I would say that based on cash, all the changes we are making with the FC2 and the improvements we're seeing with the FC2 portal, the increases we're seeing in our U.S. public sector based also on our global public sector space for the FC2 product, coupled with the fact that we have payments due from the sale of Entadfi, we continue to flex our operating expenses and look for ways to make improvements. So again, I don't see any issues as we look out beyond the 12-month time period.

Thank you, Michele. I just want to add to that. We are very excited about the base business. The base sexual health business has continued to support us. To refresh everybody's memory, we had a peak year of $60 million, and then we went to $34 million. Prior to that, it was $30 million to something $45 million and then to around $30 million and down to $18 million. It generates real money and has been our success, so we don't dilute our shareholders. I'm a big shareholder, and as a result, I am very sensitive to dilution. We've found that the internet has been crucial. Yes, we have received business from the global public sector, we've seen more business in the U.S. public sector as well. But primarily, it's the U.S. prescription business, Affordable Care Act, and the growing demand for non-hormonal birth control that gives women control over their reproductive health. We happen to be in the right business at the right time. Based on our numbers, we expect growth, and we are optimistic about 2024. We believe we are good for the next 12 months, and moving into late 2024 and into 2025, the portal should significantly help us financially to continue developing our 2 main Phase III programs. Regarding your second question about the trial, our study involves enobosarm monotherapy in a later-line patient population than ENABLAR-2. In some cases, these patients have previously been treated with 4 or 5 or more therapies. There are around 50 patients enrolled in that monotherapy study, and some patients are still on the study. Data reporting will occur after we complete the clinical study report.

Our next question comes from Yi Chen with H.C. Wainwright.

This is a question on behalf of Yi Chen. The first question is about ENABLAR. Do you expect a specific minimum overall response rate from the Stage 1 portion of the study in order to obtain accelerated approval?

Yes, that's a good question. As long as we stay hypothetical, I'm happy to share some thoughts. The real question regards what we think our overall response rates could be. If you look at the 5 arms, based on literature, for the second-line patient population that has failed CDK4/6 inhibitors and estrogen-blocking agents, the expectation for the estrogen active control is around 4% to 5% ORR. This is actually drawn from the most recent study where elacestrant was an active control, which involved patients who failed CDK4/6 inhibitors and estrogen-blocking agents. The reported ORR in that study was about 4%. For abemaciclib, the ORR alone is around 9%, although we do not have abemaciclib alone, but in combination with enobosarm our expectations are likely to be significantly higher. Our preliminary findings show promise, with our first 3 patients showing 2 partial responses and 1 stable disease, which suggests we might see better overall response rates. Enobosarm's previous Phase II studies indicated a rate of about 30% or more in a similar population. Thus, we would expect our rates to exceed the active control of 4%, and if we see similar results as past studies, we could achieve good rates for enobosarm alone or with abemaciclib in combination.

And lastly, I'm sorry if I missed this earlier in your prepared remarks, but could you provide FC2's prescription revenue for the quarter, please?

Yes, the prescription revenue for FC2 for the quarter was approximately 4,400 prescriptions. I'm very impressed with this growth, which indicates that we're moving in a positive direction.

Our next question comes from Leland Gershell with Oppenheimer.

I wanted to ask a couple of questions. With respect to ENABLAR-2, just to understand. Since those 3 initial patients, as you were evaluating the combination, have you been enrolling additional patients? Or are you just starting to enroll patients into Stage 1?

Here's what happened. We preplanned for 3 patients to be in what we refer to as Stage 1A, which was our first assessment of the combination of abemaciclib with enobosarm to ensure there were no drug-drug interactions with the pharmacokinetics. We selected enobosarm 9 milligrams, the dose we used in the Phase II study in the monotherapy arm, alongside the approved dose of abemaciclib for this assessment. Once we received the data, which showed no harmful interactions and no new safety issues, our initial scan revealed 2 partial responses and stable disease in the first group of patients. We went on to the FDA seeking clarity, which resulted in the advice to maintain the enobosarm at 9 mg while showing interest in dose optimization. Our goal is to proceed with 3 mg plus 1 mg combinations to fully assess the monotherapy separately from the combination therapy. Everything we are doing has required significant dialogue with the FDA to ensure all aspects are clear, and we anticipate enrollment will pick up next quarter when we are ready with 1 mg and 3 mg enobosarm supplies.

Understood. With respect to the public aspect of FC2, did you comment on whether you have additional payments remaining on the South African tender and what potential value you foresee for the Brazil tender?

Yes. Michele, can you comment on that?

Sure. The South Africa tender has just begun. We secured a significant portion of this tender, so the sales have recently started. It's a 3-year tender process, giving us a sizable opportunity ahead with multiple distributors in South Africa to continue supplying product during this timeframe. For Brazil, there's typically a break between tender cycles and the new tender is expected towards the end of this calendar year. We anticipate this tender to be in the area of 15 million to 20 million units, which is contingent on the government's decision on how much they will put out for bid. In most cases, they allocate a portion of the tender for non-latex products; we qualify for that, which allows us to bid on a segment of the tender. These tenders usually last for about 18 months.

Yes, and to summarize, we expect this business to continue, especially considering our lengthy history with the South African market, having been active for 20 years. So we anticipate ongoing success. Overall, we have a U.S.-based business that is growing, marked by tangible success, especially reflected in the prescription business and the 115% increase in our U.S. public sector gains. We're also witnessing departments of health resuming orders after a long hiatus during the pandemic when resources were primarily directed towards vaccines and protective measures, consequently limiting orders for preventative health products.

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.

Thank you, operator. I appreciate everybody joining us on today's call. I look forward to updating all of you on our progress in our next investor call. Have a great afternoon. Bye.

The conference call has now concluded. Thank you for attending today's discussion. You may now disconnect.