Veru Inc.

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 Fish, Beru 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 of 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 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, Chief Scientific Officer, Michelle Greco, Chief Financial Officer and Chief Administrative Officer, Philip Greenberg, General Counsel, and Sam Fish, Executive Director of Investor Relations and Corporate Communications. Thank you for joining our year-end fiscal year 2025 earnings call. Vero 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 entity small molecules, inovasarm and sabizabulin. The first one is inovasarm. an oral selective antireceptor modulator, or SARM, is being developed as a next-generation drug that makes weight reduction by GLP-1 receptor agonist drugs more tissue-selective of fat loss with preservation of lean mass. This activity is intended to lead to greater weight loss by improved body composition and physical function compared to GLP-1 receptor agonist treatment alone, with a focus on older patients with obesity. A second asset is subisobulin, a microtubule disruptor, and is being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation to slow the progression and promote the regression of atherosclerotic cardiovascular disease. This morning, we will focus on the update of our obesity program, and we'll also provide the financial highlights for our fiscal year 2025. Now, let's set the stage with the recent FDA guidance on obesity drug development. The FDA defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, not to reduce lean mass. Reduction of fat mass ultimately leads to improvements in morbidity and mortality associated with obesity. GLP-1 receptor agonists have been shown to reduce significant weight loss in patients who are overweight or have obesity. Unfortunately, the weight loss is tissue non-selective, with the indiscriminate loss of both significant lean mass and fat. Of the total weight loss, up to 50% is attributable to lean mass. Although the GLP-1 receptor agonist treatment results in profound weight loss, the strategy for the next generation of obesity drugs should be a combination therapy with a GLP-1 receptor agonist to only lose fat while preserving lean mass and physical function for a quality weight reduction. Now, when we started our Phase IIb quality clinical trial evaluating Novosarm as a muscle-preserving drug in patients with obesity receiving a GLP-1 receptor agonist for weight reduction about two years ago, it was unknown at the time how any muscle anabolic drug would perform in this unique new patient population. The companies that were in Phase II testing stage were Lilly, Versanis, Scalaroc, and Regeneron, with injectable agents in the myostatin inhibitors class, and Viru, with an oral Novosarm from a different class called SARM. Fast forward to today. All these companies, including Viru, have reported their Phase II clinical results. In fact, Viru was the first company to report these clinical data in January of 2025, and by September of 2025, Vera also obtained FDA regulatory clarity to advance the clinical development of the Noxon in combination with the GLP-1 receptor agonist as a muscle preservation agent that augments fat loss. Our completed positive phase 2B quality clinical trial results were critical as they demonstrated oral Noxon could be that next generation drug in combination with the GLP-1 receptor agonist to make the weight loss journey more selective by losing fat while preserving lean, and physical function in older patients who have obesity with a positive safety profile. Now, turning to the results of the Phase 2B clinical trial, this time with a focus on the 3-milligram Inovasarm dose that has been selected for the next clinical trial. First, I will highlight the results for the 16-week active weight loss period of the treatment with Inovasarm 3 milligrams or placebo in combination with semaglutide. The Inobisarm 3 mg plus semaglutide group met the primary endpoint of the study, preservation of total lean mass with a statistically significant 100% average preservation of total lean mass compared to placebo plus semaglutide treatment group at 16 weeks. The Inobisarm semaglutide treatment resulted in a dose-dependent greater loss of fat mass compared to placebo plus semaglutide with the Inobisarm 3 mg group having a 12% greater fat loss at 16 weeks. Even with having preserved lean mass, anovosome 3 milligrams for semaglutide treatment resulted in a similar mean body weight loss at semaglutide alone at 16 weeks. However, it should be noted, in a subset analysis of the subjects receiving anovosome 3 milligrams who had a baseline BMI of greater than or equal to 35, incremental weight loss was observed at 16 weeks. This was weight loss of 4.7% for semaglutide versus a minus 5.58% for inovasone 3 milligrams for semaglutide treatment group. But when you look at the proportion of patients that lost at least 5% of their body weight at 16 weeks, it was 47.4% for semaglutide versus 65.4% for inovasone 3 milligrams for semaglutide treatment group. This weight loss occurred even with 84% preservation of lean mass in this subset of patients receiving semaglutide on anobisarm 3 mg. Now, the tissue composition of the total body weight loss on average was 34% lean mass and 66% fat mass in the placebo semaglutide group, whereas for anobisarm 3 mg and semaglutide group, the weight loss was 0% lean and 100% fat mass. Now, we measured physical function by the stair climb test. This was a pre-specified responder analysis, and this was conducted using greater than 10% decline in stair climb power as a cutoff at 16 weeks, which is a decline that represents approximately 7 to 8 years of loss of stair climb power that naturally occurs with aging, but it occurred in this case in 16 weeks. The magnetite alone resulted in the loss of physical function as much as 44.8% of the placebo plus semactite group had at least a 10% decline in stair climb power at 16 weeks. The Phase IIb quality studies were first to confirm that older patients with obesity receiving a GLP-1 receptor agonist indeed had a significant and relevant physical function decline and picked up as early as 16 weeks on treatment. Contrasts. Novus arm 3 milligram treatment reduced the proportion of patients receiving semaglutide to 17.6% who experienced a greater than 10% decline in sterocline power. This represents a 59.8% relative reduction in the proportion of patients receiving a novus arm who experienced a greater than equal 10% decline in sterocline power. Now, for the maintenance extension portion of the study, will all patients discontinue semaglutide treatment but continued receiving placebo and Novus on 3 milligrams as monotherapy for 12 weeks, the results were, for the placebo and monotherapy group, they actually regained 43% of their body weight that was previously lost during the active weight loss period of the Phase IIb quality study, but mean percentage change at 2.57%, basically 5 pounds they gained back in body weight, compared to 1.41% or 2.73 pounds for the 3-milligram Inovasarm group. This means that the 3-milligram Inovasarm monotherapy significantly reduced body weight regain by 46% after discontinuing the semaglutide. But by the way, the mean tissue composition of the body weight that was actually regained was 100% lean mass, not fat, for the Inovasarm 3-milligram group compared to 28% fat 72% lean mass in a placebo group. In fact, by the end of the 28-week study, the inoboson 3 mg plus semaglutide arm, followed by the inoboson 3 mg monotherapy regimen, was more effective in preserving 100% lean mass and losing 58% more fat compared to the group receiving placebo plus semaglutide, followed by placebo monotherapy alone. As for safety... At the end of the 16-week active weight loss period, Inovasarm and semaglutide combination had a positive safety profile, and Inovasarm did not have any added gastrointestinal adverse events compared to semaglutide alone. For the maintenance extension period of the clinical trial, when semaglutide was stopped for 12 weeks, Inovasarm monotherapy also had a positive safety profile, and after discontinuation of semaglutide, There were essentially no gastrointestinal side effects, no evidence of drug-induced liver injury, no increases in obstructive sleep apnea were observed at any dose of Inovasarm compared to placebo monotherapy. There were no adverse events related to masculinization in women, and there was no adverse events related to increases in prostate-specific antigen, which is PSA, in men. So in summary, phase 2B quality clinical trial confirms that by preserving lean mass and physical function with the Novozom plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, the Novozom monotherapy significantly prevented the regain of body weight and fat mass, such that by the end of the 28-week study, there was a greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group. Next, I will update you on the ANOVA-SARM clinical development plan. Because this field is very new, the regulatory landscape continues to evolve for muscle preservation drugs for the treatment of obesity. According to the FDA feedback on Viru's clinical development program for ANOVA-SARM, FDA has guided us that there are at least two possible regulatory pathways forward for the development of ANOVA-SARM in combination with GLP-1 receptor agonists that 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 nervous arm in combination with GLP-1 receptor agonist treatment compared to GLP-1 receptor treatment alone is an acceptable primary endpoint to support efficacy for approval. Second, and alternatively, if the incremental weight loss difference of less than 5% is less than 5%, including similar weight loss, is observed, and 52 weeks of maintenance treatment, but you have a clinically significant positive benefit, such as a clinically beneficial preservation of physical function, and Novosarum in combination with a GLP-1 receptor agonist may also be acceptable to support efficacy for approval. Accordingly, with this feedback from the FDA, in building on the clinical data from the Phase 2B clinical, excuse me, Phase 2B quality study, What would be the best patient population with obesity to target with a combination of anobis arm and a GLP-1 receptor agonist? An emerging common and serious clinical and therapeutic challenge with GLP-1 receptor agonist monotherapy is that most patients with obesity by the end of one year of GLP-1 receptor agonist maintenance treatment hit a weight loss plateau. The weight loss plateau occurs when the patient with obesity stops losing additional weight while on a GLP-1 receptor agonist. In a Surmount 1 clinical study conducted by Eli Lilly and Company, about 88% of patients with obesity receiving terzapatide reached the weight loss plateau by 60 to 72 weeks. Unfortunately, 62.6% of these patients still had clinical obesity at a time they reached the weight loss plateau. If they start the GLP-1 treatment with a baseline BMI of greater or equal to 35, then these patients were on average still found to have clinical obesity at the time they hit the weight loss plateau. Interestingly, one of the therapeutic interventions being considered for this patient population is bariatric surgery to address the GLP-1 receptor weight loss plateau. To address this growing weight loss plateau population, A novel combination of the GLP-1 receptor agonist, which works by telling the brain to reduce the appetite, combined with an ozone, which is designed to directly burn fat and to directly preserve muscle to increase physical function and burn more calories, could break through this weight loss plateau, leading to incremental weight reduction, thereby increasing the number of patients with obesity who actually achieve and maintain a normal BMI and weight. Our next study will target this patient population. The planned Phase IIb plateau clinical trial will measure incremental weight loss in this target population who have more weight to lose, with a BMI greater than 35, and more at risk for physical decline, physical limitations, age greater than or equal to 65, to assess the ability of a novus arm treatment to break through the weight loss plateau, and help us also to better inform the design of the Phase III development program. Now, for the planned Phase IIb plateau clinical trial, We will evaluate the effect of a NovoSom 3mg on total body weight, physical function, and safety in approximately 200 patients who have obesity, BMI greater than or equal to 35, and who are older, age greater than or equal to 65, and are initiating a GLP-1 receptor treatment for weight reduction. The primary efficacy endpoint of the study will be the percent change from baseline and total body weight at 72 weeks, and interim analysis will be conducted at 36 weeks to assess the percent change from baseline lean body mass and fat mass as measured by DEXA scan. Since we want to continue to evaluate Inovasarm as a muscle preservation and body composition drug, the key secondary endpoints would be function endpoints, physical function stair climb tests, mobility disability status, which is functional limitations, and patient reported outcome questionnaires for physical function, such as the SF-36, PF-10, and the IWQOL light CT physical function PROs, as well as body composition endpoints, total fat mass, total lean mass, and bone mineral density. As for our financial position to fund the Phase 2B program, as of September 30, 2025, our cash and cash equivalents and restricted cash balance was $15.8 million, and subsequent to September 30, 2025, On October 31st of 2025, we completed a public offering that resulted in net proceeds to the company of approximately $23.4 million. The clinical studies expect to begin in the first quarter of calendar year 2026. An interim analysis to assess change in lean mass and fat mass as measured by DEXA will be conducted at 36 weeks and is anticipated to be in the first quarter of calendar year 2027. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?