Veru Inc.

Good morning, ladies and gentlemen, and welcome to VarioInc's 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, this event is being recorded. I would now like to turn the conference over to Mr. Sam Fish, VarioInc's 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 are actual results may differ significantly from those projected, suggested, or included in any forward-looking statements. Risks that may cause actual results or developments that 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, VeryWings Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michelle Greco, Chief Financial Officer and Chief Administrative Officer, Michael Purvis, the General Counsel and Executive Vice President of Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our Q3 fiscal year 2024 earnings call. Vera is a late clinical stage biopharmaceutical company focused on developing innovative medicines for high-quality weight loss, oncology, and acute respiratory distress syndrome. The company's drug development pipeline includes two late-stage novel oral small molecules, Inovasarm and Subizabulin. In our weight loss pipeline, we have Inovasarm, also known as Osterine, MK2866, GTX024, and VIRU024, which is an oral selective angio-receptor modulator, SARM for short. Inovasarm is being developed as a treatment in combination with a weight-loss drug like a glucagon-like peptide-1 receptor agonist, also known as a GLP-1 receptor agonist, to augment fat loss and to avoid muscle loss in overweight or obese patients for chronic weight management. In our oncology pipeline, impending additional external funding or pharmaceutical partnership, we have Inovasarm in combination with Abemacyclib as a second-line treatment for angioreceptor-positive, estrogen receptor positive, and human epidermal growth factor 2 negative metastatic breast cancer. In our infectious and inflammatory disease pipeline, and similarly pending additional external funding of pharmaceutical partnership, we have subizobulin, a microtubule disruptor, which is a planned phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARTS. The company also has an FDA-approved commercial product, the FC2 female condom internal condom, for dual protection against unplanned pregnancy and sexually transmitted infections. This morning, we'll provide an update on the current focus of our company, which is the development of Inovasarm, an oral SARM in combination with Rigovit, which is semaglutide, a GLP-1 receptor agonist, to preserve muscle mass and to augment fat loss for a potentially higher quality weight loss. We'll also provide financial highlights for our third quarter fiscal year, 2024. Lipo receptor agonists, which include Ozempic, Wegovy, Cefbound, and Manjaro, are very effective drugs that cause significant weight loss. Unfortunately, up to 50% of the total weight loss comes from muscle, which is problematic, as muscle is necessary not only for strength and physical function, but also muscle is a metabolic tissue that may play a role in allowing a higher quality weight loss. To clarify this point, Muscle preservation may assist in higher quality weight loss in three ways. First, we need a drug that, given in combination with a glucoin receptor agonist, will prevent the loss of muscle caused by a glucoin receptor agonist to preserve physical function in older adults who are at risk for muscle loss and who are overweight and obese. According to the CDC, 42% of older adults have obesity in the United States and could benefit from weight loss medications. Up to 34% of obese patients over the age of 60 have sarcopenic obesity, sarcopenia being the age-related loss of muscle. This large subpopulation of sarcopenic obese patients is especially at risk when taking a GLIP1 receptor drug for weight loss, as they may already have critically low amounts of muscle due to age-related muscle loss. Because of the magnitude and speed of muscle loss, while on a GLIP1 receptor agonist therapy for weight loss, GLIP1 receptor agonist drugs may accelerate the development of frailty and muscle weakness in obese or overweight elderly patients. Muscle weakness may lead to poor balance, decreased gait speed, mobility disability, loss of independence, and higher risk for falls and fractures. In fact, the safety section of the package insert for Bagovi has been updated based on the recently reported select cardiovascular outcome clinical trial, which now highlights a 400% increase in pelvic and hip fractures that were observed in patients greater than the age of 75 years receiving Regovi compared to placebo patients, and that was 2.4% versus 0.6%. Fractures of the hip and pelvis typically occur because of falls, which increase with decreased muscle mass. Second, for all patients who are overweight or obese, muscle preservation may prevent the GLIP1 receptor agonist weight loss plateau. Significant depletion of muscle mass may be one of the may also be one of the reasons why patients with GLP-1 receptor agonist drugs reach a weight loss plateau, meaning the rate of weight loss slows or stops while taking a GLP-1 receptor agonist drug. The hypothesis is that loss of muscle creates a muscle deficit that causes a low energy balance and triggers in the brain a signal to increase appetite that counters the inhibition of appetite from GLP-1 receptor agonist drugs, thus leading to the weight loss plateau. Without a muscle deficit, glucoid drugs may maintain the loss of appetite and reduction of calorie consumption, which may potentially remove more fat mass with greater weight loss. Third, for all patients who are overweight or obese, muscle depletion may trigger the overeating that occurs when the patient discontinues a glucoid receptor agonist, resulting in a rebound weight gain. That is, they regain their original weight. But now, the regained weight is composed of almost all fat. Having a drug that maintains adequate muscle reserve when a gluplein receptor drug is discontinued may prevent this rebound weight gain and help with the maintenance of weight loss. We believe that Inovus Arm, our novel oral selective antireceptor modulator, may be the best drug candidate to address this urgent unmet medical need to preserve muscle in patients receiving a gluplein receptor agonist for weight loss. Data from our clinical trials and preclinical studies support Novosarm's potential. Novosarm is given as a once-a-day oral dose. Novosarm works through the androgen receptor, a well-established mechanism. Novosarm demonstrates tissue selectivity as it improves and preserves lean body mass, muscle mass, and physical function. In addition, Novosarm also directly causes a breakdown of fat and prevents storage of fat, resulting in a decrease in fat mass. This represents a different, non-overlapping mechanism of drug action to reduce fat that's distinct from a GLP-1 receptor agonist, which suppresses appetite, resulting in a low caloric state. Therefore, if Inova's arm is given with a GLP-1 receptor agonist, the combination utilizes two different mechanisms to increase the loss of fat. Also, Inova's arm builds and heals bone, providing another potential benefit to treat bone loss, which is also known as osteoporosis, to prevent fractures. Inovasorm has been previously studied in five clinical studies that measured muscle as an endpoint, involving 968 older men and postmenopausal women, as well as older patients who have muscle wasting because of advanced cancer. An advanced cancer population is relevant, as advanced cancer causes a loss of appetite, resulting in significant unintentional loss a wasting of both muscle and fat mass, similar to what's observed with a GLP-1 receptor agonist treatment. The totality of the clinical data from these five clinical trials demonstrates that Inovasarm treatment leads to increases in muscle mass with improvements in physical function as well as significant reduction in fat mass. The expectation is that Inovasarm in combination with a GLP-1 receptor agonist would both preserve muscle and augment fat reduction resulting in a higher quality total weight loss. Furthermore, Inovus Arm has a large safety database, which includes 27 clinical trials involving 1,581 men and women dosed with Inovus Arm, with some patients dosed for over two years. In this large safety database, Inovus Arm is generally well-tolerated without masculinizing effects in women. Reversible mild liver enzyme elevations have been reported which are mostly grade 1 adverse events, there were no grade 3 or grade 4 adverse events. To be clear, no drug-induced liver injury has been observed from any of the 27 clinical studies evaluating Inovasar. Furthermore, there are no increases in gastrointestinal side effects compared to placebo. This is important, as there's already significant frequent gastrointestinal side effects with a GLIP1 receptor agonist treatment alone. Now, turning to our Novosarm clinical program for high-quality weight loss, we're conducting the Phase IIb Quality Clinical Trial, so Quality is the name of the trial, which is a multicenter, double-blind, placebo-controlled, randomized dose-finding study to evaluate the safety and efficacy of Novosarm 3mg and Novosarm 6mg compared to placebo in combination with Begovi, which is semaglutinase, Glyph1 receptor agonist, in approximately 150 older patients greater than the age of 60 who are overweight or obese. The purpose of the Phase 2B clinical trial is to select the optimal dose of Anobis arm in combination with a glucomy receptor agonist that best preserves muscle and augments the reduction of fat mass for a better body composition at 16 weeks of treatment. The primary endpoint to the Phase 2B clinical trial will be the change in total lean body mass from baseline to 16 weeks, and key secondary endpoints will be the change from baseline to 16 weeks in total fat mass, total body weight, and physical function as measured by the serocline test. After completing the 16-week efficacy dose-finding portion of the Phase IIb clinical trial, participants will then continue into a blinded Phase IIb extension clinical trial, where all patients will stop receiving a GLIP1 receptor agonist but will continue taking placebo, Inovasarm 3 mg, or Inovasarm 6 mg for an additional 12 weeks. The blinded phase 2B extension clinical trial will evaluate the maintenance of weight loss, meaning whether Inovasarm can maintain muscle and prevent the fats and weight gain that occurs after discontinuing the GLIP1 receptor agonist. We believe that assessing the effects of Inovasarm on lean body mass and fat mass at 16 weeks' time point should be adequate to demonstrate significant loss of muscle in a semaglutide and placebo cohort. Support comes from the STEP1 study reported by Wilding et al. in the New England Journal of Medicine. The STEP1 study that evaluated semaglutide for weight loss in overweight and obese patients showed that 49% of the total weight loss that's lost in that 68-week study occurred by week 16. Approximately 40% of the total weight loss was attributed to muscle loss. As Inovasarm is a muscle drug that also burns fat, our current Phase 2B clinical program is designed to provide body composition clinical data to support the Phase 3 clinical development of Inovasarm for precision, high-quality weight loss by answering the following clinical questions related to muscle. For at-risk older adults who are overweight or obese, can Inovasarm prevent loss of muscle to preserve physical function. For all patients who are overweight or obese, can InovaSARM preserve muscle to prevent the GLP-1 receptor agonist weight loss plateau? And for all patients who are overweight or obese, can InovaSARM maintain adequate muscle reserve when GLP-1 receptor agonists are discontinued to prevent the rebound weight gain, which is almost all fat? I'm proud of our team. as they have expeditiously executed the Inova's Arm Phase 2B Quality Clinical Program. We prioritized the company's clinical development activities to address this new important unmet need in November of 2023. We filed the IND with the FDA in January of 2024. We received FDA clearance on the IND in February of 2024. We made a strategic decision to upsize the size of the trial to 150 patients to increase the power of the study. We initiated this Phase 2B quality study in April of 2024. Clinical studies being conducted in 14 clinical sites in the United States. This morning, I'm pleased to report that we have completed the greater than 150 patient enrollment for the Phase 2B quality study. can now anticipate that the last patient to complete the Phase 2B quality study will be in December of 2024, with top-line clinical results of the Phase 2B clinical study expected in January of 2025. Furthermore, the top-line results of the separate blinded Phase 2B extension clinical study may now be expected in the second calendar quarter of 2025. We believe we have sufficient financial resources on hand cash of $29.2 million at the end of June 2024 to complete and provide results in both the Phase IIb Quality Clinical Trial and the Phase IIb Extension Clinical Trial. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?