Veru Inc.

Good morning, ladies and gentlemen, and welcome to VeriWinx Investors Conference Call. All participants will be in listen-only mode. Should you need assistance, please sit down with a conference specialist or pressing the star key followed by zero. After this morning's discussion, there will be an opportunity to ask questions. Please note, this event is being recorded. I would now like to turn the conference over to Mr. Sam Fish, VeriWinx Executive Director, Investor Relations and Corporate Communications.

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, regulatory interactions, finances, and development and product portfolio. Such forward-looking statements are subject to known and unknown risks and uncertainties, and their actual results may differ significantly from those projected, suggested, and or included in any forward-looking statements. Risks that may cause actual results or development 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, VeriBank's Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, the Chief Scientific Officer, Michelle Greco, the CFO, CAO, Michael Purvis, the EVP General Counsel on Corporate Strategy, and Sam Fish, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our call. Viviro is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology. The company has a commercial sexual health program called UREV which includes two FDA products, Intadfi, a new treatment for benign prostatic hyperplasia, and the FD2 condom, internal condom, for the dual protection against unplanned pregnancy and the transmission of 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 premium market opportunities. This morning... We'll provide an update on our COVID-19 Subisibulin clinical program, the clinical development of oncology drug pipeline, and the commercialization of our products in the UREP program. We'll also provide financial highlights for our first quarter fiscal year 2023. First, I will update you on the status of Subisibulin, an investigational drug candidate for the treatment of hospitalized adult COVID-19 patients and high-risk ARDS, which is the lead indication for our infectious disease program. We reported positive results from the Phase 3 COVID-19 clinical trial, which is a double-blind, multi-center, multinational, randomized placebo-controlled study evaluating daily oral 9 mg doses of bisabolin for up to 21 days versus placebo in 204 hospitalized moderate to severe COVID-19 patients who are at high risk for ARDS and death. On April 8, 2022, the Independent Data Monitoring Committee conducted a planned interim efficacy analysis in the first 150 subjects randomized in the Phase III COVID-19 study. After reviewing the unblinded clinical data, the Independent Data Monitoring Committee unanimously recommended that the Phase III study be halted early due to clear clinical efficacy benefit. The Independent Data Monitoring Committee also remarked that no safety concerns were identified. In this interim analysis, subvisivulin treatment demonstrated statistically significant 24.9 percentage point absolute reduction, and a 55.2% relative reduction in all-cause mortality by day 60, the primary efficacy endpoint of the study, with a p-value equal to 0.0042. The efficacy was further supported by the consistency of the mortality benefit across subgroup analyses of the primary endpoint. Clinically meaningful reductions in deaths with subvisual treatment compared to placebo was observed regardless of the standard of care treatment received baseline WHO ordinal score, sex, age, baseline comorbidities, BMI, or geographic location. In the full final data set of 204 randomized patients, the all-CARS mortality benefit was similar to the positive clinical results observed in the interim efficacy analysis population, with subisobulin treatment resulting in a 51.6% relative reduction in deaths compared to placebo treatment, p-value 0.0046. Data from the key secondary efficacy endpoints demonstrated that sabizabulin treatment resulted in a significant reduction in days in the ICU, days on mechanical ventilation, days in the hospital compared with placebo. Sabizabulin also had an acceptable safety profile. Significantly fewer adverse and serious adverse events were reported with sabizabulin compared to placebo. There were also fewer treatment discontinuations due to adverse events in the sabizabulin group compared with placebo. The Phase III reported safety profile suggests that subvisivulin treatment may have resulted in fewer COVID-19-related morbidities, especially respiratory failure, pneumothorax, acute kidney injury, cardiac arrest, septic shock, and hypotension. Next, I will update you on the U.S. and international regulatory progress for subvisivulin for the treatment of COVID-19. On May 10, 2022, we had a pre-emergency use authorization meeting with FDA. In this meeting, FDA agreed that that no additional efficacy studies would be required to support an emergency use authorization or an NDA pending review. FDA also agreed that no additional safety data would be required to support an EUA, but the collection of safety data under the EUA would satisfy the safety requirement for an NDA. FDA confirmed these positions in writing in the meeting minutes which were sent to us after this meeting. Based on the FDA's feedback from this meeting, On June 6, 2022, we submitted a request for an EUA application to FDA. On November 9, 2022, the U.S. FDA's Pulmonary Allergy Drugs Advisory Committee met with the company to review its request for EUA of sabizobulin. Although the advisory committee voted 8 to 5 that the known or potential benefits of sabizobulin when used for the treatment of adult patients hospitalized with COVID-19 and high-risk ARDS do not outweigh known or potential risks to bisapulin, there was additional discussion by the advisory committee around possible clinical trial design aspects for a potential confirmatory Phase III clinical trial as a post-EUA authorization requirement. FDA is supposed to consider the input of the advisory committee as part of its review of the EUA, but FDA makes the final decision on the emergency use authorization application. We believe we meet the criteria for EUA issuance based on FDA guidance. One, COVID-19 is a serious or life-threatening disease or condition. Two, based on the totality of the scientific evidence available, it's reasonable to believe that subizobulin may be effective. Three, risk, benefit, and analysis, the known and potential benefits of subizobulin, which is the mortality benefit, outweigh the known and potential risks. There are no adequate, approved, and available alternatives to the candidate product for treating the disease or the condition. It's been three months since the FDA Advisory Committee meeting, and we have been in contact with FDA and they have communicated to us that they are still reviewing our requests for EUA. We, however, do not know when the FDA will act on our EUA. January 30th, 2023, the White House Office of Management and Budget announced that the Biden administration plans to terminate the COVID-19 national and public health emergencies on May 11th, 2023. The United States Department of Health and Human Services, also known as HHS, however, also had declared a national emergency, which is a separate one from the White House in 2020, and which is still in effect, and based on current information, is expected to remain in effect beyond May 11th. As HHS governs the FDA, the FDA, to avoid confusion, also announced on January 31st, 2023, that the May 11th termination would not impact FDA's ability to authorize new treatments for emergency use, that existing EUAs would remain in effect, and that it may continue to issue new EUAs when criteria for issuance are met. As for our regulatory progress outside the U.S., on July 27, 2022, we announced that the European Medicines Agency, the EMA, emergency task force had informed the company that it has initiated the review of cebizobulin for the treatment of hospitalized COVID-19 patients and high risk for acute respiratory distress syndrome. The review will assist the 31 EU member states who may consider allowing use of the medicine before a formal marketing authorization is granted. The review of sabizabulin is the first to be triggered under Article 18 of the new EU regulation that expanded the role of the EMA during public health emergencies in 2022. We have been in active communication with the Emergency Task Force as they complete the review of sabizabulin And once the emergency task force completes their review, they will submit their formal recommendation to the EMA's Committee for Medicinal Products for Human Use, also known as CHMP. And CHMP then reviews the recommendation and renders an opinion whether subisobulin qualifies for emergency use in Europe. If the EMA authorizes it for emergency use under Article 18, then the individual nations in the EU may authorize subisobulin for use. We've also completed our final rolling submission to the Access Consortium Nations, which is composed of the following regulatory agencies. UK's Medicine and Healthcare Products Regulatory Agency, also known as MHRA, Switzerland's Swiss Medic, Australia's Therapeutic Goods Administration, known as TGA, and the Access Consortium is a coalition of certain regulatory authorities with therapeutic products that work together to promote greater regulatory collaboration and alignment of regulatory requirements. This month, we expect to also complete our final rolling submission to Health Canada. In summary, we have submitted regulatory requests for emergency authorizations to the European Union, United Kingdom, Australia, Switzerland, and Canada. We're also in various stages of discussions with regulatory agencies in other countries to obtain emergency or expedited authorizations for Subisibulin, including South Korea, Israel, Egypt, New Zealand, and South Africa. Turning to our U.S. and international subisobulin commercialization preparation update, in anticipation for the potential commercialization of subisobulin, we have scaled up manufacturing processes and have enough commercial drug supply on hand to address the expected drug needs following a potential authorization in the U.S. and Europe, as well as other potential international authorizations and approvals. As an update for the commercialization of subisobulin in the U.S., we currently have in place an experienced team to commercialize subisobulin. We have also executed contracts with wholesalers for specialized hospital distribution services for Subisibulin. We believe we're ready to launch Subisibulin to hospitals across the United States if we're granted emergency use authorization soon. We also have established Bureau International to commercialize Subisibulin to the rest of the world. We are making great progress in the potential international commercialization of Subisibulin. In January of 2023, we had additional discussions with the Health Emergency Preparedness and Response Authority, also known as HERA, H-E-R-A, which is part of the European Commission. HERA is responsible for joint procurement framework contracts, which offers 36 participating countries the possibility to jointly procure medical drugs and countermeasures as an alternative or complement to procurement at the national level. Joint procurement framework contracts have been previously signed with Gilead, Hoffman LaRouge, GSK, and most recently in November of 2022 with Pfizer. The company is also making great progress in signing up international commercial partners to, assuming appropriate regulatory approvals, facilitate securing sub-isobulin government purchase orders for COVID-19, as well as ensuring seamless flow of sub-isobulin to their countries. So Mezion Pharma in South Korea, Valeo Pharma in Canada, have publicly announced partnerships with Viru. We also have signed commercial partnerships in China, Australia, New Zealand, and Egypt with highly regarded local partners. And although they have not publicly announced these transactions yet, they have been diligently working on the commercial opportunity for several months now. We have been engaged for some time in negotiating partnerships also with Germany, Italy, United Kingdom, Ireland, Spain, Switzerland, France, Israel, and Taiwan. We're also excited to expand the investigation of sabizabulin to other infectious disease indications based on the drug candidate's novel mechanism of action if we receive an emergency use authorization in the U.S. or other authorizations outside the U.S. that leads to substantial new revenue. As we have preclinical in vivo data that demonstrates that sabizabulin has activity against H1N1 variant of influenza A, also known as the swine flu, We plan to conduct a Phase III clinical study to evaluate subizobulin in hospitalized adult patients with influenza A who are at high risk for ARDS. Influenza A virus causes up to 52,000 deaths and 710,000 hospitalizations each year in the U.S. Similarly, if subizobulin is authorized and commercialized, we also plan to conduct a Phase III clinical study of subizobulin for the treatment of hospitalized adult patients with viral ARDS, which would include respiratory syncytial virus, which alone causes 14,000 deaths in 177,000 hospitalizations each year in the U.S. As we have outlined above, sibizabulin as a novel antiviral anti-inflammatory is positioned to potentially become a valuable treatment option for multiple infectious diseases that can lead to ARDS, a life-threatening lung condition that has a high mortality rate. I will now briefly discuss the progress of our oncology drug portfolio focused on advanced breast and prostate cancers. In advanced breast cancer, we have been actively enrolling two registration clinical trials. The R-Test Phase III clinical trial in approximately 210 patients to evaluate a novus arm monotherapy for the third-line treatment of AR-positive, ER-positive, HER2-negative metastatic breast cancer. In number two, the second trial, Phase III, is the Enabler Phase III clinical study in approximately 186 patients to evaluate the efficacy and safety of Inovus arm and the Bemacyclib combination therapy versus an alternative estrogen-blocking agent in subjects with AR-positive, ER-positive, HER2-negative metastatic breast cancer who have failed first-line therapy with Pablociclib, which is a CDK4-6 inhibitor, plus an estrogen-blocking agent. We have a clinical trial collaboration excuse me, clinical trial collaboration and supply agreement with Lilly for the Enabler 2 Phase 3 clinical study. Under the terms of the non-exclusive clinical trial collaboration and supply agreement, Vera is responsible for conducting the clinical trial, while Lilly is supplying Abemacyclib for the study. Vera remains full exclusive global rights to Novozyme. The Phase 3 Enabler 2 study has two stages. Stage 1 is a pharmacokinetics and safety assessment of the combination of anobisarm and abemacyclob to make sure there are no drug-to-drug interactions resulting in changes in blood levels of either drug, and that there are no added safety concerns before going to stage two. Stage two is the actual phase three study. We have completed phase one, which consists of three patients, and there are no changes in the expected blood levels for anobisarm or abemacyclob when given in combination, and the combination is well tolerated. Interestingly, Evidence of objective anti-tumor activity was observed in target lesions at the eight-week CT scan in all three patients as follows. The first patient had a 50% reduction of an adrenal metastasis. The second patient had a 21% reduction of a liver metastasis. And the third patient had a 71% reduction of a liver metastasis. Full trial, the stage two portion of the trial, as I mentioned, is enrolling. In advanced prostate cancer, we have been actively enrolling a Phase III and Phase II clinical trial. We have been actively enrolling an open-label, randomized, multicenter Phase III veracity clinical trial evaluating subizobulin 32 mg versus an alternative antigen-receptor-targeted agent for the treatment of chemotherapy in naive men with metastatic castration-resistant prostate cancer who had tumor progression after previously receiving at least one antigen-receptor-targeted agent. The primary endpoint is radiographic progression-free survival. Enrollment for the Phase III veracity clinical study is ongoing. A second clinical study in prostate cancer is evaluating VIR-100, a GnRH antagonist three-month depo formulation, in a Phase II dose-finding clinical study for the treatment of hormone-sensitive advanced prostate cancer. As we will discuss later, we're currently evaluating our clinical trial priorities and spending as we await decisions on by FDA, European regulatory and other bodies on for COVID-19 and we're working to conserve cash. When decisions on reprioritizations or suspension of any trials or termination of any trials or programs or any modifications to R&D efforts have been finalized, we will communicate them to you. Viru has a commercial sexual health program called UREV, which includes two FDA-approved products, FC2 and Entadfi. We have built the infrastructure to allow for broad market access to FC2 across the U.S. As a result, FC2 is now available through multiple sales channels. We have partnered with telemedicine platform sexual health companies to bring FC2 products to patients in a cost-effective and highly efficient, highly convenient manner. Fortunately, the telemedicine sector and global public sector ordering have underperformed across the board this past calendar year. It does appear, however, that market conditions are improving. And we are seeing revenues increase in Q2 fiscal year 2023. We also have Intadvi, an FDA-approved new treatment for benign prostatic hyperplasia. It's currently prescribed BPH medicines may lead to the most common side effects of sexual adverse events. Intadvi has demonstrated its faster and more effective treatment option for BPH than finasteride alone and does not cause sexual side effects. We've launched this product during the fourth fiscal quarter of 2022. with a focus on payer agreements as well as executing distribution, wholesaler, and Medicare contracts. In addition to traditional distribution, we're also seeking distribution through GoodRx and telemedicine partners. I will now turn the call over to Michelle Greco, CFO and CAO, to discuss the financial highlights. Michelle?