Veru Inc.

Good morning, ladies and gentlemen, and welcome to VARU 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 call over to Mr. Sam Fish, VARU'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 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 10Q and 10K 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, Barrow Inc.' 's Chairman, CEO, and President.

Good morning. With me on this morning's call are Dr. Gary Barnett, our Chief Scientific Officer, Michelle Greco, our Chief Financial Officer and Chief Administrative Officer, Phil Greenberg, General Counsel, and Sam Fisch, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our first quarter fiscal year 2026 earnings call. Here is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program consists of two new chemical entities, small molecules, Inovasarm and Subizabula. The first one, Inovasarm, is an oral selective angio-receptor modulator, SARM, and is being developed as a next-generation drug that when combined with a GLP-1 receptor agonist, and as demonstrated in our company's recently completed Phase II quality study, makes weight reduction more tissue-selective, the fat loss and preservation of lean mass and physical function, which is intended to lead to greater weight loss compared to GLP-1 receptor treatment, to receptor agonist treatment alone, with a focus on older patients with obesity. A second asset, civizibulin, a microtubule disruptor, is being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression or promote the regression of of atherosclerotic cardiovascular disease. This morning, we will focus on the update of our obesity program, and we will also provide financial highlights. The fiscal 2026 first quarter ended December 31st, 2025. GLP-1 receptor agonists 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 indiscriminate significant loss of both lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass. Although the GLP-1 receptor agonist treatment has resulted in profound weight loss for many patients, the strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist for patients to lose fat only while preserving lean mass and physical function and bone mineral density for the highest quality weight reduction. Bureau's completed positive phase 2B quality clinical trial conducted in 168 older patients with obesity provided the proof of concept that Nozarm could be that next generation drug in combination with the GLP-1 receptor agonist to make the weight loss journey more selective for only fat loss while preserving lean mass and physical function during the active weight loss period, but also notably after semaglutide was discontinued, and those on monotherapy significantly prevented the regain of both body weight and fat mass, such that by the end of the 28-week study, there was greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group. In September of 2025, we announced a successful FDA meeting providing regulatory clarity for the development of the Novozarmin combination with a GLP-1 receptor agonist for greater quality weight loss and treatment of obesity. According to FDA feedback, there are at least two possible regulatory pathways for the development of the Novozarmin combination with a GLP-1 receptor agonist treatment for obesity with preservation of lean mass, which are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with a novus arm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor agonist treatment alone may be an acceptable primary endpoint to support efficacy for approval. Second, if the incremental weight loss is less than 5% corrected weight loss, including similar weight loss at 52 weeks of maintenance treatment with a novus arm in combination with GLP-1 receptor agonist treatment compared to a GLP-1 receptor agonist treatment alone. But the Inovasarm treatment group demonstrates a clinically significant positive benefit, such as a statistically significant and clinically meaningful benefit in the preservation of physical function. This may also be acceptable to support efficacy for approval. FDA also confirmed that Inovasarm 3 mg is an acceptable dosage for future VIRU clinical development. Now, coincidentally, On December 19, 2025, the FDA announced that total hip bone mineral density, that's BMD, assessed by DEXA scan, qualifies as a validated surrogate endpoint for drug development in postmenopausal women with osteoporosis at risk for fracture instead of the current standard that requires Phase III clinical studies must use bone fractures as a primary endpoint. This is relevant for our NovoSom obesity program, As it's been reported in the scientific literature, the GLP-1 receptor agonist therapy affects body composition by also reducing hip BMD. In fact, the semi-acrytide Rigobi FDA label has recently been updated to include the safety concern of increased risk of hip and pelvic fractures based on a select cardiovascular trial, which is sponsored by Novo Nordisk and over 17,000 subjects. In the select trial, Four to five times more hip fractures of the hip and pelvis were reported on the GOBI than in placebo in female patients and in all patients age 75 and older. The good news for our NovoSARM obesity program is that in previously published preclinical studies and rat models of postmenopausal female osteoporosis, NovoSARM has been shown to have both anabolic and anti-resorptive activities that result in increased bone mineral density. Consequently, this means that distinct from incremental weight loss or muscle preservation and physical function as primary endpoints, improving BMD in postmenopausal women with obesity receiving a GLP-1 receptor agonist who also have osteoporosis can be another primary endpoint going forward for a no-sarm-to-seek regulatory approval for improving body composition. Now let's turn to the current status of our planned phase 2B plateau clinical study. A common and serious clinical and therapeutic challenge of GLP-1 receptor agonist treatments is that 88% of patients with obesity after one year on a GLP-1 receptor agonist drug hit a weight loss plateau where they stopped losing additional weight. This is based on the Suramount One study conducted by Eli Lilly and Company. Unfortunately, 62.6% of these patients still have clinical obesity at the time they reach the weight loss plateau. One explanation might be that the loss of muscle may stimulate appetite in patients receiving a GLP-1 receptor agonist to consume more calories, which may be an important reason why patients hit that weight loss plateau. Noveson has been shown in clinical studies to directly burn fat to preserve muscle to increase physical function and to burn more calories, which would help break through that weight loss plateau, leading to incremental weight reduction. Vero's planned Phase 2B plateau clinical study is a double-blind, placebo-controlled study to evaluate the effect of a no-sum 3 mg on total body weight, fat mass, lean mass, physical function, bone mineral density, and safety in approximately 200 older patients aged greater or equal to 65 years of age who have obesity with a BMI of greater or equal to 35. and are initiating semaglutide treatment for weight reduction. The primary efficacy endpoint to study is the percent change in baseline and total body weight at 68 weeks. An interim analysis will be conducted at 34 weeks to assess the percent change in baseline in lean body mass and fat mass as measured by DEXA scan. The key secondary endpoints, the total fat mass, total lean mass, physical function using the Sterifine test, bone mineral density, and patient-reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Simaglutide was selected as a GLP-1 receptor agonist for the Phase IIb plateau study to build on Viru's previous clinical experience using a Novosarm in combination with Simaglutide in the Phase IIb quality clinical study. Further, there's now an oral form of Simaglutide which may be used in combination with oral Inovasarm in future Phase III clinical studies, making the potential bridging of the future Phase III clinical studies data to the Phase IIb Plateau Inovasarm plus injectable semaglutide data possible. In contrast, Terzepatide injectable does not have an oral formulation. The principal investigator for the Phase IIb Plateau clinical trial will be, again, Steven Himesfield, M.D., professor and the director of the Body Composition Metabolism Laboratory at the Pennington Biomedical Research Center in Baton Rouge, Louisiana. The clinical study is expected to begin this quarter. An interim analysis to assess change in lean body mass and fat mass as measured by DEXA will be conducted in 34 weeks, which is anticipated to be in the first quarter of calendar year 2027. I will now turn the call over to Michelle Greco, CFO of CAO, to discuss the financial highlights. Michelle?