Veru Inc. (VERU) came out with a quarterly loss of $0.07 per share versus the Zacks Consensus Estimate of a loss of $0.06. This compares to loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -16.67%. A quarter ago, it was expected that this company would post a loss of $0.05 per share when it actually produced a loss of $0.07, delivering a surprise of -40%. Over the last four quarters, the company has surpassed con ...

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle during weight loss, oncology, and viral-induced acute respiratory distress syndrome [8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - Enobosarm is being evaluated in a Phase 2b clinical trial to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide [3] - The primary endpoint of the trial is total lean body mass, with key secondary endpoints including total body fat mass and physical function measured by stair climb test at 16 weeks [3] - Topline clinical results from the Phase 2b trial are expected by the end of calendar year 2024, followed by a Phase 2b extension trial to assess muscle maintenance after discontinuation of GLP-1 RA [4] Sarcopenic Obesity Context - In the U.S., 41.5% of older adults have obesity, with up to 34.4% of these patients over 60 years old suffering from sarcopenic obesity [5] - Sarcopenic obesity patients are at risk of muscle loss when taking GLP-1 RA medications, which can lead to frailty and increased mortality [5] Enobosarm's Mechanism and Safety - Enobosarm is a selective androgen receptor modulator (SARM) that has shown dose-dependent increases in muscle mass and reductions in fat mass in previous studies involving older patients [6][7] - The safety database for enobosarm includes 27 clinical trials with 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [7] Future Development Plans - The company plans to conduct a Phase 3 ENABLAR-2 clinical trial of enobosarm in combination with abemaciclib for treating AR+ and ER+ metastatic breast cancer, subject to funding availability [9] - Sabizabulin is being developed for hospitalized patients with viral-induced ARDS, with further development contingent on securing external funding [10]

Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle, weight loss, oncology, and viral-induced acute respiratory distress syndrome (ARDS) [4][8] - The company's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [8] Enobosarm Clinical Trials - A Phase 2b clinical trial is underway to evaluate the safety and efficacy of enobosarm at doses of 3mg and 6mg, or placebo, in approximately 150 patients with sarcopenic obesity or overweight elderly patients receiving semaglutide (Wegovy®) [1][17] - The primary endpoint of the trial is total lean body mass, with key secondary endpoints including total body fat mass and physical function measured by stair climb test at 16 weeks [1] - Following the initial trial, participants will enter a Phase 2b extension trial to assess whether enobosarm can maintain muscle and prevent fat and weight gain after discontinuing GLP-1 RA [5] Market Context - According to the CDC, 41.5% of older adults in the U.S. have obesity, with 34.4% of these patients over 60 years old suffering from sarcopenic obesity [6] - This demographic is at risk for muscle loss when taking GLP-1 RA medications, which may lead to frailty and increased mortality [6] Enobosarm's Mechanism and Previous Studies - Enobosarm is a selective androgen receptor modulator (SARM) that has shown dose-dependent increases in muscle mass and reductions in fat mass in previous studies involving older adults and cancer patients [7][16] - The expectation is that enobosarm, in combination with GLP-1 RA, could enhance fat reduction and total weight loss while preserving muscle mass [7] Safety Profile - Enobosarm has a large safety database from 27 clinical trials involving 1581 participants, indicating it is generally well tolerated with no significant gastrointestinal side effects [16]

MIAMI, FL, July 29, 2024 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced the company will be participating in one-on-one meetings with investors at the BTIG Virtual Biotechnology Conference on August 5th, 2024. The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-f ...

About the Enobosarm Phase 2b clinical trial About Enobosarm Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of * Wegovy® is a r ...

Investor and Media Contact: About Sarcopenic Obesity According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA m ...

Veru Inc. (NASDAQ:VERU) Q1 2024 Earnings Conference Call May 8, 2024 8:00 AM ET Company Participants Sam Fisch - Investor Relations & Corporate Communications Mitchell Steiner - Chief Executive Officer Michele Greco - Chief Financial Officer Gary Barnette - Chief Scientific Officer Conference Call Participants Dennis Ding - Jefferies William Wood - B. Riley Securities Rohan Mathur - Oppenheimer Operator Good morning ladies and gentlemen and welcome to Veru Inc.'s Investors Conference Call. [Operator Instruc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 As of May 6, 2024, the registrant had 146,383,920 shares of $0.01 par value common stock outstanding. (Former Name, Former Address and ...

Exhibit 99.1 Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Veru Reports Fiscal 2024 Second Quarter Financial Results and Progress of its Enobosarm High Quality Weight Loss Clinical Program —Phase 2b clinical study of enobosarm in combination with semaglutide (Wegovy®*) for high quality weight loss is actively enrolling— High Quality Weight Loss Program Update: The Company's high quality weight loss program is f ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Commission File Number 1-13602 | | | (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 2916 N. Miami Avenue, Suite 1000, Miami, FL 33127 (Address of Principal Executive Offices) (Zip Code) 305-509-6897 (Registrant's Telephone Number, Including Area Code) N/A Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller r ...