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 call over to Mr. Sam Fisch, 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 developments that differ materially are contained in our 10-Q and 10-K SAC 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, Barrow Inc.'s Chairman, CEO, and President.

Good morning. With me on this morning's call is Dr. Gary Barnette, our Chief Scientific Officer, Michele Greco, Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, our General Counsel, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining us in our third quarter fiscal year 2026 earnings call. Vera is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two novel small molecules, inobasarm and sabizabulin. The first one, inobasarm, is an oral selective angioreceptor modulator, SARM, and is being developed as a next generation drug that when combined with a GLP-1 receptor agonist makes weight reduction More tissue selected for fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to a GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. Our second asset, tabizabulin, is a microtubule disruptor. It's being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of the clinical development progress of Inovasarm in our obesity program. We will also provide financial highlights for fiscal 2026 third quarter ended June 30th, 2026. GLP-1s have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, this weight loss is tissue non-selective with the significant indiscriminate loss of both lean mass and fat mass. of the total weight loss up to 50% is attributable to lean mass loss. Although GLP-1 receptor agonist treatment has resulted in substantial weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 receptor agonist to cause patients to only lose fat while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Viewer has focused on the clinical development of the Novozarm for quality weight loss in older patients who may have sarcopenic obesity. This means these patients have both obesity and low muscle mass and are potentially at the greatest risk for reduction to a critically low muscle mass, which may lead to physical function decline when taking a currently approved GLP-1 receptor agonist. As muscle mass loss alone does not define sarcopenia, we chose to objectively evaluate and measure physical function by a stair climb test, which is a common activity of daily living. Bureau completed the Phase 2B quality clinical study, which was a multi-centered, double-blind, placebo-controlled, randomized dose-finding clinical trial designed to evaluate the safety and efficacy of a Novosarm 3mg, Novosarm 6mg, or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older patients greater or equal to the age of 60 receiving semaglutide, which is Regovi, for weight reduction. It should be noted that the Phase IIB Quality Clinical Trial was the first human study to demonstrate that weight reduction in older patients who have obesity receiving a GLP-1 receptor agonist put them at higher risk for accelerated loss of lean mass with physical function declines. Further, the novus arm treatment preserved lean mass muscle, which translated into a reduction in the proportion of patients that had a clinically significant physical function decline when compared to patients receiving a GLP-1 receptor agonist alone. Based on this short-term Phase IIb quality study, we believe there's an urgent, unmet need for a drug that prevents the loss of muscle and physical function, as well as augments the loss of fat, for greater weight loss in at-risk older patients with sarcopenic obesity receiving a GLP-1 receptor agonist for weight reduction. Now, a common and serious clinical and therapeutic challenge with GLP-1 receptor agonist treatments is that 88% of patients after one year on a GLP-1 receptor drug hit what's called a weight loss plateau, where they stopped losing additional weight. Based on the Surmount One study conducted by Eli Lilly and Company, 62.6% of these patients unfortunately still have clinical obesity at the time they reach this weight loss plateau of one year. One explanation might be that the non-selective loss of muscle caused by weight loss may reach a point that now stimulates appetite in patients receiving a GLP-1 receptor agonist so they consume more calories, which in turn may cause patients to stop losing weight and hit their weight loss plateau. The clinical issue may be potentially more problematic in older patients that start out with low muscle reserves and who lose, who lost further muscle mass with weight loss but remain obese when they hit the weight loss plateau. It has been shown in previous studies that InovaSom directly burns fat and preserves muscle and physical function which should burn even more calories. Thus retaining muscle, appetite stays suppressed while more calories are burned which could help to break through the weight loss plateau leading to incremental weight reduction. We are currently conducting and have fully enrolled the Phase 2B Plateau Clinical Trial, which is a double-blind placebo-controlled study to evaluate the effect of Inovasom 3 mg on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients aged greater than or equal to 65 who have obesity with a BMI greater than or equal to 35. and are initiating semagnetide with GOVI, GLP-1 receptor agonist treatment for weight reduction. The primary efficacy endpoint of this study is the percent change from baseline and total body weight at 68 weeks and interim analysis will be conducted at 32 weeks to assess the percent change from baseline lean body mass and total fat mass as measured by DEXA scan. The key secondary endpoints for the overall study A Total Fat Mass, Total Lean Mass, Physical Function with the Sterocline Test, Mobility Disability Assessment, Bone Mineral Density, and a Patient-Reported Outcome Questionnaires for Physical Function, HbA1c, and Insulin Resistance. The objective of the Phase IIb Plateau Clinical Trial is to focus on the effects of longer-term GLP-1 receptor agonist treatment in older patients who have obesity. The Phase IIb Plateau Clinical Study will also assess the ability of the Novosarm treatment to potentially break through the weight loss plateau observed in patients receiving GLP-1 receptor agonist treatment to achieve a clinically meaningful incremental weight reduction as well as preserve muscle mass and physical function by 68 weeks. We recently announced we have completed full enrollment of the Phase IIb Plateau Clinical Trial with 239 patients enrolled. This puts us on track for a near-term milestone, which is reporting the results of the 32-week intro analysis, which is expected in Q1 calendar year 2027. Simaglutide was selected as a GLP-1 receptor agonist for the Phase IIb PLATO study to build on Viro's previous clinical experience using an ovosarum in combination with simaglutide in the positive Phase IIb quality clinical study. Further, the clinical data from the Phase IIb Plateau clinical trial using injectable semaglutide may support the use of oral semaglutide and oral Inovasarm fixed dose combination in future Phase III clinical trials. The choice for selecting semaglutide was also a strategic one. On June 2, 2026, Vero entered into a supply agreement with Novo Nordisk for the Phase IIb Plateau clinical trial. In this agreement, VERU is solely responsible for conducting and sponsoring the Phase IIb Plateau Clinical Study. Novo Nordisk will supply Wegovy to VERU at no charge, as required for the conduct of the Phase IIb Clinical Study. Novo Nordisk provides Wegovy solely for use within the study under the supply agreement. In return, VERU will provide Novo Nordisk with insights into obesity and weight management trial design, Methodology and Clinical Conduct, including regular clinical study updates, protocol changes, and safety updates. While Vero maintains full global development and commercialization rights in Novosarm, Vero has granted Novo Nordisk a right of first negotiation if Vero in the future intends to develop, commercialize, or license a Novosarm intellectual property in combination with any Novo Nordisk GLT-1 product. including Rigobi for any indication. For further information, please see Veru's Form 8-K, filed with the SEC on June 4, 2026. As for developments regarding InnovaSARM's intellectual property, the company recently announced that it had received from the United States Patent and Trademark Office a notice of allowance for key methods of use, U.S. patent application titled Compositions Comprising Selective Angioreceptor Modulator in combination with weight loss drugs and use thereof for quality weight loss. The notice of allowance encompasses treatment regimens where, one, the novus arm is concurrently given with semaglutide with the set of co-therapy continuing. Two, the novus arm is added to initial semaglutide monotherapy with the set co-therapy continuing. And, three, the novus arm continues or is initiated after semaglutide therapy is discontinued. The allowed claims are directed to, one, preservation, restoration, and gaining of lean body mass and muscle mass. Two, enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation to improve body composition, lower body fat content, and lower fat mass. Three, preservation, restoration, and improvement of physical function, and the corresponding prevention and treatment of a number of conditions that can result from decreased physical function, such as reducing or treating muscle weakness or poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and or increased mortality. Four, preservation, restoration, or gaining a bone and a corresponding prevention and treatment of bone fractures. Overcoming and Improving Insulin Resistance, 6, Improving HbA1c, 7, Reduction or Treatment of Prevention to Prevent Total Body Gain Rebound After Discontinuing Semaglithide, 8, Reduction of or Treatment to Prevent Fat Mass Gain Rebound After Discontinuing Semaglithide, and nine, treatment to prevent or restore lean mass loss during the rebound after discontinuing semaglutide. When issued, the U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. These allowed claims add to the company's worldwide portfolio of patent applications directed to the method of use of the Novus arm in combination with weight loss drugs for higher quality weight loss and incremental weight loss, including already issued Novus Onc specific polymorph composition matter patents, as well as a number of other patent uses of selective antireceptor modulated compounds alone, or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications. The company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. In addition, the patent portfolio at Vero includes patent applications directed to a novel, oral, modified release in Novosarm formulation, which if such patent were to issue, would provide patent protection until at least May of 2046. Now, Vero is targeting Novosarm for the at-risk older patients with sarcopenic obesity, which is a very large market. The prevalence of obesity in patients who are 65 years or older is 41.5%, among the 47.4 million patients enrolled in Medicare Part D plans, which is about 20 million potential patients. Reimbursement for weight loss drugs continues to improve for patients over 65 years of age, and according to Medicare.gov, starting July 1, 2026, Medicare covers these GLP drugs. Tondeo Tablet, Rigobi Injectional Tablet, and Zepbound the QuickPen only. I will now turn the call over to Michele Greco, CFO and CAO to discuss the financial highlights. Michele.