Veru Inc.

Good morning, ladies and gentlemen, and welcome to Veru Inc'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 that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fish, Veru Inc's Executive Director, Investor Relations and Corporate Communications. Please go ahead.

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 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, Vero Inc.' 's Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, the Chief Scientific Officer, Michelle Greco, Chief Financial Officer and Chief Administrative Officer, Michael Purvis, Executive Vice President, General Counsel and Corporate Strategy, and Sam Fish, the Executive Director of Investor Relations and Corporate Communications. Thank you for joining our Q2 fiscal year 2024 earnings call. Vero 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 Vero024, which is an oral selective androgen receptor modulator, SARM, Novosarm is being developed as a treatment in combination with glucagon-like peptide 1 receptor agonist, which I'll be referring to as GLIP1 receptor agonist, which is a weight loss drug, to augment fat loss and to avoid muscle loss in overweight or obese patients for chronic weight management. In oncology pipeline and pending additional external funding or pharma partnership, we have Novosarm in combination with abemacyclob as a treatment for angio-receptor-positive estrogen receptor positive, and human epidermal growth factor receptor 2 negative metastatic breast cancer in the second-line setting. In our infectious disease pipeline, similarly pending additional external funding or form of partnership, we have sabizabulin, a microtubule disruptor, which is in a planned phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The company also has an FDA-approved commercial product, the FC2 female condom, internal condom, for dual protection against unplanned pregnancy and sexually transmitted infection. This morning, we'll provide an update on the primary focus of our company, the development of Inovasarm and Oralsarm in combination with Rigobis and Semiglutide, a GLIP1 receptor agonist, to avoid muscle loss and to augment fat loss for potentially higher quality weight loss. We'll also provide financial highlights for our second quarter fiscal year 2024. GLP-1 receptor agonists like a Zympic, Wegovy, Zepan, Manjaro are very effective weight loss drugs. Unfortunately, up to 50% of total weight loss comes from muscle, which is problematic, as muscle is necessary for metabolism, strength, and physical function. Loss of muscle may be one of the reasons why patients on GLP-1 receptor agonist drugs reach a weight loss plateau. meaning the rate of weight loss slows or stops while taking a glyphine receptor agonist drug. According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of obese patients over the age of 60 have sarcopenic obesity. This large population of sarcopenic obese patients is especially at risk when taking a glyphine receptor agonist 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 in a glucoin receptor agonist therapy for weight loss, glucoin 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 Regovi has been updated based on the recently reported Select Cardiovascular Outcomes clinical study, which now highlights a 400% increase in pelvic and hip fractures that were observed in patients greater than 75 years of age receiving Regovi compared to placebo. That's 2.4% versus 0.6%, which was statistically significant with a p-value of 0.0073. and a 500% increase in pelvic and hip fractures in females of any age, that's 1% versus 0.2%, which was statistically significant at p-value of 0.0005. Fractures of the hip and pelvis typically occur because of falls, which increase with decreased muscle mass. Consequently, we believe there is an urgent unmet medical need for a drug when given in combination with a glucomoreceptor agonist that could prevent the loss of muscle while preferentially reducing fat in not only all overweight or obese patients, but also for the large subpopulation of sarcopenic obese or overweight elderly patients who are at risk for developing muscle atrophy and muscle weakness leading to frailty. We believe that NovusArm, our novel oral selective antireceptor modulator, may be the best drug candidate to address this urgent unmet medical need. Data from our clinical trials and preclinical studies support NovusArm's potential Nose arm is a once-a-day oral dosing. Works through the androgen receptor, which is a well-established mechanism. It demonstrates tissue selectivity. For example, it improves and preserves muscle mass and physical function. 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 is distinct from GLIP1 receptor agonists. Lipo-1 receptor agonists suppress appetite to create a low caloric state. So if Inovasarm is given with a Lipo-1 receptor agonist, the combination utilizes a different mechanism to increase the loss of fat. Inovasarm builds and heals bone, potential to treat bone loss, also known as osteoporosis, to prevent fractures. Inovasarm has been previously studied in five clinical studies involving 968 older men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a low-calorie state because of loss of appetite with a significant unintentional loss or wasting of both muscle and fat mass similar to what is observed with the GLIP1 receptor agonist treatment. The totality of the clinical data from these five clinical trials demonstrate that nervous arm treatment leads to increases in muscle mass with improvements in physical function as well as significant reductions in fat mass. The expectation is that Inovasarm, in combination with a GLP-1 receptor agonist, would potentially preserve muscle and augment the fat reduction by two different mechanisms, resulting in higher quality total weight loss. More importantly, Inovasarm has a large safety database, which includes 27 clinical trials involving 1,581 men and women dosed with Inovasarm, with some patients dosed for over two years. In this large safety database, Inovasarm was generally well-tolerated without masculinizing effects in women. Reversible mild liver enzyme elevations have been reported, but no drug-induced liver injury has been observed in any of the clinical studies evaluating Inovasarm. Furthermore, there were no increases in gastrointestinal side effects. This is important, as there are already significant and frequent gastrointestinal side effects with GLP-1 receptor agonist treatment alone. Now, turning to the Inovasarm clinical program for high-quality weight loss, the Phase IIb multicenter, double-blind, placebo-controlled, randomized dose-finding clinical study to evaluate the safety and efficacy of Inovasarm 3 mg, Inovasarm 6 mg compared to placebo in combination with Magovi, so that's semaglutide, which is the GLP-1 receptor agonist, in approximately 90 older patients over the age of 60, who are overweight or obese. The purpose of the Phase 2B clinical trial is to select the optimal dose of Inovasarm in combination with a gluplein receptor agonist that best preserves muscle and augments the reduction of fat mass with 16 weeks of treatment. The primary endpoint of the Phase 2B clinical trial will be the change in total lean body mass from baseline to 16 weeks. The key secondary endpoints include will be the change in baseline to 16 weeks in total fat mass, insulin resistance, total body weight, and physical function as measured by stair climb tests. We initiated the Phase 2B study, enrolling our first several patients in April of 2024, and the clinical studies plan to be conducted in approximately 15 clinical sites in the United States. The top-line clinical results of the Phase 2B clinical trial are expected at the end of calendar year 2024. We believe that assessing the effects of the Novosarmin lean body mass and fat mass at 16 weeks should be adequate to demonstrate significant loss of muscle in the semaglutide placebo cohort. Support comes from the Step 1 study reported by Wilding et al. in the New England Journal of Medicine. The Step 1 study that evaluated semaglutide for weight loss in overweight and obese patients showed that 49% of the total weight loss in a 68-week study occurred by week 16. and approximately 40% of the total weight was attributed to muscle loss. Now, after completing the 16-week efficacy dose-finding portion of the Phase 2B clinical trial, participants will then continue until a blinded Phase 2B extension clinical trial, where all patients will stop receiving the GLIP1 receptor agonist, but will continue taking the placebo, Inovasarm 3 milligrams, or Inovasarm 6 milligrams for an additional 12 weeks. The blinded phase 2B extension clinical trial will evaluate whether Novosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a glipine receptor agonist. The top-line results of the separate blinded phase 2B extension clinical study are expected in calendar Q2 2025. If Novosarm is a muscle drug that also burns fat, our current phase 2B clinical program is designed to provide clinical data to support the development of Novosarm for precision, high-quality weight loss by answering the following clinical questions related to muscle. For the at-risk older patients who are overweight or obese, can a Novus arm prevent the loss of muscle to preserve physical function? Older patients who have or who may develop sarcopenic obesity, that is, they have both low muscle reserves and are overweight, are at high risk for accelerated development of frailty, muscle weakness, and physical function decline while receiving a GLP-1 receptor agonist. Second question, for all patients who are overweight or obese, can anobisarm preserve muscle to prevent the GLP-1 weight loss plateau? The hypothesis is that loss of muscle creates a muscle deficit, and that triggers an increase in appetite. This increase in appetite counters the hypocaloric benefit of GLP-1 drugs, leading to weight loss plateau. Without the deficit, GLIP1 drugs may potentially remove more fat and be able to maintain a hypochloric state. By the way, Novosarm has direct effects on fat to further increase fat loss. Third question. For all patients who are overweight or obese, can a Novosarm maintain adequate muscle reserve when the GLIP1 receptor agonist drugs are discontinued to prevent the rebound weight regain, which is almost all fat? We're excited that our Phase 2B clinical study has been initiated and is enrolling. We believe we have sufficient financial resources on hand, which include the recent financing of the net proceeds of $35.2 million to complete and provide results in both the Phase 2B clinical trial and the Phase 2B extension clinical trial. I will now turn the call over to Michelle Greco, CFO and CAO, to discuss the financial highlights. Michelle?