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. Michael Purvis, Veru, Inc.' 's General Counsel and Executive Vice President of 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, Bureau, Inc.' 's Chairman, CEO, and President.

Thank you, Michael. Good morning. With me in this morning's call are Dr. Gary Barnett, Chief Scientific Officer, Michelle Greco, the Chief Financial Officer and Chief Administrative Officer, and Michael Purvis, the General Counsel and Executive Vice President of Corporate Strategy. Thank you for joining our Q3 fiscal year 2025 earnings call. Vera 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 clinical stage drug candidates, Inovasarm and Sabizabulin. Inovasarm is an oral selective antireceptor modulator, also known as Asarm. It's being developed as a novel drug that makes GLP-1 receptor agonist weight reduction more tissue selective by preserving lean mass, which is muscle, while causing greater fat loss in older patients who are overweight or have obesity. Sabizabulin is an oral microtubule disruptor. being developed as a broad anti-inflammatory agent to reduce vascular plaque inflammation and slow the progression or promote the regression of atherosclerotic cardiovascular disease. This morning, we'll focus our update only on our chronic weight loss management program. As defined by FDA, obesity is a disease of excess body adiposity of fat. Therefore, the medical objective to treat obesity by weight reduction drug or drugs in combination should be to reduce the excess body fat, not lean mass, to improve the morbidity and mortality associated with obesity. GLP-1 receptor agonists have been shown to produce significant weight loss in patients who are overweight or have obesity. Unfortunately, the weight loss is tissue non-selective and the indiscriminate loss of both fat and lean mass. Of the total weight loss, up to 50% of the total weight loss is attributable to lean mass. We must do a better job of getting rid of fat tissue only. As we previously presented the clinical data as they became available for our Phase II program, I will now present a summary of all of these important findings. We have demonstrated in the Phase II-B quality study that Inovus Arm is a next-generation drug that makes GLP-1 receptor-aggressive weight loss more tissue-selective for fat loss while preserving lean mass and physical function. In January of 2025, the company announced positive top-line efficacy data from the Phase IIb Quality Clinical Study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of anobosomal 3 milligrams, anobosomal 6 milligrams, or placebo as a treatment to augment fat loss and prevent muscle loss in 168 older men, excuse me, older patients greater than 60 years of age receiving somatotype for chronic weight management. Inovasone plus Imaglutide group met the primary endpoint of the study with a statistically significant 100% average preservation of total lean mass compared to placebo plus Imaglutide at 16 weeks, and that p-value is less than 0.001. Inovasone plus Imaglutide treatment resulted in a dose-dependent greater loss of fat compared to placebo plus Imaglutide, with the Inovasone 6 mg dose having a 42% greater relative loss of fat mass compared to the placebo semaglutide group in 16 weeks, and that p-value is 0.017. The inovosome 3 mg group had a 12% greater fat loss. Even with having preserved the lean mass, the inovosome plus semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone in 16 weeks. And the tissue composition of the total body weight loss was 34% lean mass and 66% fat mass for the placebo group. for the semaglutide group, whereas it was 0% lean mass and 100% fat mass for the inovasome 3 milligrams for the semaglutide group. Physical function was measured by the sterocline test. Respondent analysis was conducted using greater than the 10% decline in sterocline power as a cutoff at 16 weeks, which represents approximately 7 to 8 years loss of sterocline power that naturally occurs with aging. The Phase IIb Quality Clinical Trial is the first human study to demonstrate that older patients who are overweight or have obesity receiving semaglutide are at higher risk for accelerated loss of physical function, as 44.8% of the placebo plus semaglutide group had at least a 10% decline in power of physical function at 16 weeks. The NovoSom treatment preserved the lean mass, which translated into a reduction in the proportion of patients that had a clinically significant sterocline physical function decline, with 17.6% of the Inovasar in 3 mg plus somatic type group having at least a 10% decline in sterocline power function in 16 weeks, which is a 59.8% relative reduction in a proportion of patients that lost at least 10% sterocline power compared to placebo somatic type group, and that p-value is 0.006. In May of 2025, the company announced that Novus arm and semaglutide combination had a positive safety profile in the Phase 2B Quality Clinical Trial. Now, after the trial participants completed the efficacy dose finding portion of the Phase 2B Quality Clinical Trial, 148 participants continued to the Phase 2B Maintenance Extension Study. This is a double-blind study. where all patients discontinued semaglutide treatment but continued receiving placebo, Inovasarm 3 milligrams, or Inovasarm 6 milligrams as monotherapy for 12 weeks. In June of 2025, the company announced positive top-line efficacy and safety results in the maintenance extension portion of the Phase 2B quality clinical study that showed that Inovasarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation. As a point of reference, at the end of the Phase IIb quality study active weight loss period of 16 weeks, body weight loss was similar across treatment groups, with the semaglutide plus placebo group losing an average of about 11.88 pounds. After the 12-week maintenance extension period, where all treatment groups discontinued semaglutide, The placebo monotherapy group regained 43% of the body weight that was previously lost during the Phase II quality study for a mean percentage change of 2.57%, which is 5 pounds, compared to 1.41%, which is 2.73 pounds, for the 3-milligram group, and that p-value is 0.038. and 2.87%, which is 5.29 pounds, for the 6-milligram Inosarm group. This means that the 3-milligram Inosarm monotherapy significantly reduced the body weight we gained by 46% after discontinuation of semaglutide. By the way, the mean tissue composition of the body weight we gained was 100% lean mass in both the 3-milligram and 6-milligram groups, whereas it was 28% fat 72% lean mass in the placebo group. Inovasone plus semaglutide, followed by inovasone monotherapy regimen, was more effective in preserving lean mass and causing and maintaining greater loss of fat by the end of the study. So the placebo plus semaglutide, followed by placebo monotherapy group, experienced loss of lean mass, while the inovasone plus semaglutide group, followed by inovasone monotherapy group, significantly preserved more than 100% of lean mass, with the Inovasarm 3 mg p-value less than 0.001, Inovasarm 6 mg p-value equals 0.004. The Inovasarm plus semaglutide followed by Inovasarm monotherapy patients had a 58% greater loss of fat with Inovasarm 3 mg, p-value 0.085, and 93% greater loss of fat with Inovasarm 6 mg, and that p-value is 0.008 compared to placebo plus semaglutide followed by placebo monotherapy. Now, adverse events, and adverse events of special interest in this double-blind Phase IIb maintenance extension trial. And those on monotherapy had a positive safety profile. After discontinuation of semaglutide, there's essentially no gastrointestinal side effects, no evidence of drug-induced liver injury by Heye's Law, and no increases in and obstructive sleep apnea observed at any dose of an ozone compared to placebo monotherapy. And there were no adverse events of increases in prostate-specific antigen in men, and there was no adverse events related to masculinization in women, and there were no reports of suicidal ideation observed. In summary, the Phase IIb Quality Maintenance Extension Clinical Trial confirms that preserving lean mass with the Novosone plus semaglutide, led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, the Novosone monotherapy significantly prevented the regain of both weight and fat mass during the maintenance period, such that by the end of the study, there was greater loss of fat mass while preserving lean mass for higher quality weight reduction compared to the placebo group. On August 11, 2025, the company announced the selection of a novel modified-release oral formulation for chronic weight loss management following a pharmacokinetic clinical study. A single-dose, open-label pilot study evaluated the plasma concentration versus the time profile of a proprietary, patentable, modified-release formulation of the Novosar 3mg. The new formulation demonstrated the intended distinct target product release profile, which includes a reduction in maximum plasma concentration, which is called Cmax, a delayed time to maximum plasma concentration, called Tmax, and a distinct secondary peak concentration, and a similar extent of absorption, which is called AUC, compared to historical values for Novosar immediate release capsules. The novel modified release oral Novosarm formulation is planned to be available for the Phase III clinical study and for commercialization. The novel Novosarm oral formulation's unique manufacturing process is protected by issued global patents with protection through 2037, and the new patents on the novel modified release oral Novosarm formulation itself have been filed and have issued expiries expected to be in 2046. Now, we expect regulatory clarity for the GLP-1 receptor agonist and Novosarm combination phase 3 program as we have had an end of phase 2 FDA meeting scheduled this quarter. So we're here this quarter. The proposed indication is that Novosarm is a selective angio-receptor modulator indicated as an adjunct to GLP-1 receptor agonist therapy, a reduced calorie diet and increase physical activity and chronic weight management for greater reduction in fat mass, preservation of physical function, and preservation of lean mass in older, greater than 60 years of age, adult patients with obesity. Now, during our previous pre-IND FDA meeting, FDA provided general comments about a regulatory path forward for Inovasarm as a drug that improves body composition during chronic weight management including input on the Phase III clinical program design. So we have some preliminary information, previous information, that we've received from the FDA when we started with our pre-IND meeting. Some of these FDA comments from the pre-IND meeting were, the Novus Arm in combination with an approved incretin drug, so like a GLP-1, needs to show that there's some stabilization in lean masks that's clinically meaningful. Imaging-based changes in lean masks We need to be directly linked to improvements in how a patient feels, functions, and survives in order to support the indication related to preservation of lean mass. Improvement in sterocline performance measure is clinically meaningful, so that's one way to do it. And we need to be linked to absorber improvements in lean mass rather than weight loss itself. Sterocline test has been accepted by the FDA. again, as a point of reference, for previous drug approvals and pivotal trials. So for the treatment of the two-chain muscular dystrophy and also pivotal Phase III cancer detection studies, for the 504 and 505 lung cancer studies, have used SteriCLIM as a primary endpoint in a Phase III program. Finally, we're focusing our Phase III clinical program on an older population that could benefit from a weight reduction drug for chronic weight management, but who are at higher risk for muscle weakness and falls because of age-related loss of muscle. Now, in general, there's 47.4 million patients over the age of 60 enrolled in Medicare Part D, of which 41.5% of them could benefit from a drug for overweight or obesity. Furthermore, up to 34.4% of patients over the age of 60 with obesity in the United States have what's called sarcopenic obesity. Sarcopenic obesity means these are patients who have obesity and low muscle mass at the same time and are potentially at the greatest risk for developing critically low muscle mass when taking a currently approved GLP-1 receptor agonist. Although older patients represent a large market alone, success in this patient population could be accentuated into the combination of a no-sum and GLP-1 treatment in younger patients who have obesity, as well as diabetic and frailty populations. We're looking forward to receiving the FDA regulatory clarity for this novel unmet medical need soon. I will now turn the call over to Michelle Greco, CFO, CAO, to discuss the financial highlights. Michelle?