Veru Inc. Q2 FY2026 earnings call

• Pipeline & Unmet Need Overview

• Veru develops novel selective androgen receptor modulators (Novosarm) for combination use with GLP-1 receptor agonists (GLP-1s) to treat obesity, specifically targeting older patients with sarcopenic obesity who face elevated risk of lean mass and physical function loss when using GLP-1s alone.
• Current GLP-1 weight loss is non-selective, with up to 50% of total weight loss coming from lean mass, which accelerates physical function decline, raises fall/fracture risk, and contributes to common weight loss plateaus seen in 88% of patients after one year of GLP-1 treatment.

• Completed Phase IIb QUALITY Trial Results

• The randomized, placebo-controlled Phase IIb trial enrolled 168 patients aged ≥60 on semaglutide for weight loss, testing Novosarm 3mg, 6mg, and placebo.
• 44.3% of patients in the placebo + semaglutide group experienced at least a 10% decline in stair climb power (a measure of physical function) after 16 weeks, representing 7-8 years of natural age-related strength loss.
• Novosarm 3mg + semaglutide achieved a statistically significant 59.8% relative reduction in the proportion of patients with ≥10% stair climb power decline (p=0.0006), while 6mg Novosarm achieved a 44.1% relative reduction (p=0.051). The trial also confirmed greater fat loss with Novosarm combination treatment.

• Ongoing Phase IIb PLATEAU Trial Progress

• The double-blind, placebo-controlled Phase IIb PLATEAU trial is testing Novosarm 3mg in approximately 200 patients aged ≥65 with BMI ≥35 initiating semaglutide for weight loss. The primary endpoint is percent change in total body weight at 68 weeks, with key secondary endpoints including changes in fat mass, lean mass, physical function, and bone mineral density.
• The trial is designed to test whether Novosarm can break GLP-1 weight loss plateaus by preserving lean mass, maintaining higher calorie burn, and keeping appetite suppressed, enabling additional incremental weight loss.
• First patient enrollment was completed in March 2026, enrollment is proceeding on track, and interim analysis (after all patients complete 36 weeks of treatment) is expected in Q1 calendar 2027.
• Clinical data from this trial with injectable semaglutide will support future development of an oral fixed-dose combination of Novosarm and oral semaglutide in Phase III.

• Market Opportunity

• There are over 1 billion people globally with obesity and 2.5 billion overweight/obese adults globally, with less than 2% currently treated by the two market-leading drug manufacturers.
• In the U.S., nearly 30 million adults have sarcopenic obesity, and there are approximately 20 million obese patients aged 65+ enrolled in Medicare Part D, representing a large target market for Novosarm.

Veru Inc. is a late-stage clinical biopharmaceutical company with no approved commercial products, so there is no active product segment revenue. All income reported in the quarter stems from non-operating gains related to asset sales and fair value adjustments of equity securities. The only former product segment, the FC2 female condom business, is classified as discontinued operations, with no ongoing revenue contribution.

• Based on current operating plans, cash on hand as of the financial statement issuance date is sufficient to fund operations through the 36-week interim analysis of the Phase IIb PLATEAU trial.

• Forward-looking statements regarding trial results, regulatory approval, and market opportunity are subject to known and unknown risks that could cause actual results to differ materially from projections, with detailed risk factors disclosed in the company's SEC 10-Q, 10-K, and press release filings. • The company is not profitable and has consistently generated negative cash flow from operations, requiring external financing to fund future development beyond the upcoming interim analysis. • Clinical trial success is not guaranteed: Novosarm may fail to meet primary or secondary endpoints in the ongoing Phase IIb PLATEAU trial, which would change future development plans and potential regulatory paths.

Q: If the Phase IIb PLATEAU trial is successful, how many Phase III trials will be required, and would the trial results be able to support the approval? / A: The FDA accepts >5% incremental weight loss as a standalone primary anchor endpoint for approval. If Novosarm meets this threshold, that will be the Phase III primary endpoint, with function and bone mineral density (BMD) as secondary endpoints. If incremental weight loss is <5%, the company can pursue a primary endpoint of physical function or BMD (the FDA recently accepted BMD as a valid surrogate endpoint for fracture risk), and the PLATEAU trial has collected all the necessary data to inform a Phase III design for these endpoints. Veru is the only company focused on objective measurement of physical function in this patient population. / A: No content beyond this section rules.