Veru Inc.

Good morning, ladies and gentlemen, and welcome to the Vero, 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 this event is being recorded. I would now like to turn the conference over to Mr. Michael Purvis. Veru Inc.' 's Executive Vice President, General Counsel, and Corporate Strategy.

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 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, VeroInks Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michelle Greco, the CFO and Chief Administrative Officer, Michael Purvis, the Executive Vice President, General Counsel in Corporate Strategy, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our Q1 fiscal year 2024 earnings call. Fuhrer is a late clinical stage biopharmaceutical company focused on developing innovative medicines for high-quality weight loss, oncology, and ARDS. The company's drug development program includes two late-stage, novel, orally-administered small molecules, Inovus Arm and Subicibulin. A weight loss pipeline leads off with Inovus Arm, also known as Osterine, MK2866, GTX024, S222, and Viru024. These are all the identical, same molecule, Inovus Arms. which is an oral selective androgen receptor modulator. Novus arm is being developed as a treatment in combination with weight loss drugs to augment fat loss and to avoid muscle loss in overweight or obese patients for chronic weight management. In our oncology pipeline, we're developing a Novus arm as a treatment for androgen receptor positive, estrogen receptor positive, and human epidermal growth factor 2 negative metastatic breast cancer in the second line settings. In our infectious disease pipeline, which is pending additional external funding or pharma partnership, is tabizabulin, a microtubule disruptor, which is being developed as a phase three, in a phase three 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 the dual protection against unplanned pregnancy and sexually transmitted infections. This morning, We'll provide an update on our company's primary focus, the development of the Novosarm and Oralsarm in combination with weight loss drugs like a glucagon-like peptide 1 receptor agonist, which we're going to refer to as GLIP1 receptor agonist. These are being used to avoid, Novosarm in combination is used to avoid muscle loss and physical function loss to augment fat loss and potentially result in higher quality weight loss. We'll also provide financial highlights for our first quarter fiscal year of 2024. Now, GLP-1 receptor agonists like Ozempic, Wachovic, Stepan, and Manjaro are very effective weight loss drugs. Unfortunately, clinical studies have shown that up to 50% of the total weight loss comes from muscle, which is problematic, as muscle is necessary for metabolism, strength, and physical function. Loss of muscle may be also one of the reasons why patients on GLP-1 drugs reach a weight loss plateau, meaning they cannot lose any more weight while taking the GLIP1 receptor agonist drug. According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk when taking a GLP-1 receptor agonist drugs for weight loss, as they already have critically low amounts of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 receptor agonist medication may lead to muscle weakness, leading to poor balance, decreased gait speed, mobility, disability, loss of independence, falls, bone fractures, and increased mortality. This can lead to a condition similar to age-related frailty. Because of the magnitude and speed of muscle loss, on a GLP-1 receptor agonist therapy for weight loss, GLP-1 receptor agonist drugs may accelerate the development of frailty in obese or overweight elderly patients. We believe there is an urgent unmet medical need for a drug when given in combination with a GLP-1 receptor agonist that can prevent loss of muscle while preferentially reducing fat in not only all overweight or obese patients, but especially for the large subpopulation of sarcopenic or overweight elderly patients who are at risk for developing muscle atrophy and muscle weakness leading to frailty. We believe that Anobisarm, a novel oral selective antireceptor modulator, may be the best drug candidate to address this unmet medical need. Anobisarm has been previously studied in five clinical studies involving 960 older men and postmenopausal women, as well as older patients who have muscle wasting because of advanced cancer. simulates a starvation state where there's significant unintentional loss or wasting of both muscle and fat mass, like what is observed with the GLP-1 receptor agonist treatment. The totality of the clinical data from these five clinical trials demonstrates that Novosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function, as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five Novosarm clinical trials demonstrates in both elderly patients and in patients with a cancer-induced starvation-like state, provides strong clinical rationale for Inovasarm. Our hypothesis is that Inovasarm, in combination with a GLIP1 receptor agonist, would potentially augment the fat reduction and total weight loss while avoiding muscle loss. In addition, Inovasarm has a large safety database, which includes 27 clinical trials involving 1,581 men and women dosed with Inovasarm with a duration of treatment in some patients for up to three years. In this large safety database, Inovasarm was generally well-tolerated and no increase in gastrointestinal side effects. This is important, and there's already significant and frequent gastrointestinal side effects with the GLP-1 receptor agonist treatment alone. As for our Inovasarm clinical program for high-quality weight loss, this week I'm happy to report that FDA has cleared our investigational new drug application for our Phase IIb Multi-Center Double-Blind Placebo-Controlled Randomized Dose-Finding Clinical Trial designed to evaluate the safety and efficacy of the Novus arm, 3 milligrams, 6 milligrams of placebo as a treatment to augment fat loss and prevent muscle loss in approximately 90 randomized sarcopenic obese or overweight elderly patients receiving semaglutide who are at risk for developing muscle atrophy and muscle weakness. The purpose of the Phase IIb trial is to select the optimal dose of Inovus arm in combination with a GLP-1 receptor agonist that best preserves muscle and reduces fat after 16 weeks of treatment to advance into a Phase III obesity or overweight clinical trial. The primary endpoint to the Phase IIb clinical trial will be the change in lean body mass from baseline to 16 weeks. Key secondary endpoints will be the change in baseline to 16 weeks in total fat mass, insulin resistance, total body weight, and physical function as measured by serocline tests. We plan to initiate the Phase 2B clinical study in April of 2024, and the clinical study will be conducted in approximately 15 clinical sites in the United States. The top-line clinical results for the Phase 2B clinical trial are expected at the end of calendar year 2024. We believe that assessing the effect of Inovus arm A lean body mass and fat mass at 16 weeks should be adequate to demonstrate significant loss of muscle in the semaglutide plus placebo cohort. Support comes from the Step 1 study reported by Wilding et al. in the New England Journal of Medicine publication. In the Step 1 study, it evaluated semaglutide for weight loss in overweight and obese patients and showed that 49% of the total weight loss in the 68-week study actually occurred by week 16. and 40% of the total weight loss was attributable to muscle loss. After completing the 16-week efficacy dose-finding portion of the Phase IIb clinical trial, it is planned that participants will then continue into an open-label extension trial where all patients will receive 6 milligrams of the Novosarm monotherapy for 12 weeks to determine the ability of the Novosarm to rescue or to reverse the muscle loss and prevent fat and weight rebound after stopping a GLP-1 receptor agonist. The results of the separate Phase 2B open-label extension study are expected in calendar Q2 2025. In summary, our Phase 2B clinical program is designed to provide clinical data to support the development of Inovasarm for high-quality weight loss for two possible patient populations. The first population, Inovasarm dose finding will be evaluated in the large at-risk subpopulation of obese to overweight patients who are the sarcopenic obese to overweight elderly patients receiving GLIP1 receptor agonists for weight loss. The Inovasarm GLIP1 receptor agonist combination therapy has the potential to augment weight loss by preferentially increasing fat loss while preventing muscle loss and improving physical function, potentially leading to higher quality weight loss. Inovasar monotherapy treatment for the at-risk sarcopenic obese overweight elderly patients who discontinue a GLIP1 receptor agonist. In this case, Inovasar may rescue the patient by increasing muscle mass and improving physical function while preventing the rebound weight and fat gain that typically occurs when the GLIP1 receptor agonist is stopped. We believe we have sufficient financial resources on hand, which includes the recent financing of net proceeds of $35.2 million to complete and provide results for both the Phase 2B clinical trial and the open-label extension clinical trial. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?