Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 1-13602 Veru Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1144397 (State of Incorporation ...

-- Moderated discussion with preeminent obesity expert, Louis J. Aronne, MD, FACP and Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru -- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced the release of a Virtual Investor KOL segment featuring Louis J. Aronne, MD, FACP. As part of the segment, Mitch ...

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 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, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead, sir. Speaker1 Statements made on this conference call may be forward looking statements. Forward looking statements may include, but are not necessarily l ...

Exhibit 99.1 Investor and Media Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Veru Reports Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress —Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 — —Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 — —With positive Phase 2b QUALITY study, Ve ...

--Unblinded safety data from Phase 2b QUALITY study expected in the second quarter of calendar 2025 -- --Topline efficacy and safety data for Phase 2b extension maintenance study expected in the second quarter of calendar 2025 -- --With positive Phase 2b QUALITY study, Veru plans for end of Phase 2 meeting with FDA to discuss Phase 3 clinical program -- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, May 08, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical ...

MIAMI, May 01, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced it will host a conference call and audio webcast on Thursday, May 8, 2025, at 8:00 a.m. ET to discuss its fiscal 2025 second quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of the Company ...

MIAMI, FL, April 16, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced that the Company will present at the 2nd Annual GLP-1-Based Therapeutics Summit, taking place April 29 - May 1, 2025, in Boston, Massachusetts. Presentation Title: Phase 2b QUALITY Clinical Study: Enobosarm Preserved Lean Mass and Physical Function in Older Patients Re ...

A recording will be accessible one day after the conclusion of the conference on the Company's website at www.verupharma.com. To attend the fireside chat or conference please email Jones Trading at mdoyle@jonestrading.com. About Veru Inc. Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabuli ...

Core Viewpoint - Veru Inc. (VERU) has experienced a significant downtrend with a 9.2% decline over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround due to analysts' positive earnings outlook [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a key technical indicator used to identify oversold stocks, with a reading below 30 typically indicating oversold conditions [2]. - VERU's current RSI reading is 25.85, indicating that the heavy selling pressure may be exhausting, which could lead to a price rebound [5]. Group 2: Fundamental Indicators - There is a strong consensus among sell-side analysts regarding an increase in earnings estimates for VERU, with a 14.3% rise in the consensus EPS estimate over the last 30 days [6]. - An upward trend in earnings estimate revisions is generally associated with price appreciation in the near term, supporting the case for a potential rebound in VERU's stock price [6]. Group 3: Analyst Ratings - VERU holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [7].

Financial Data and Key Metrics Changes - The net loss for continuing operations was $1.8 million or $0.01 per diluted common share, compared to a net loss of $7.7 million or $0.08 per diluted common share in the prior year's quarter [45] - Research and development costs increased to $5.7 million from $1.7 million in the prior quarter, primarily due to expenses related to the enobosarm Phase 2b QUALITY clinical study [43] - Selling, general and administrative expenses decreased to $5.2 million from $6.7 million in the prior quarter, attributed to a decrease in share-based compensation and headcount [44] Business Line Data and Key Metrics Changes - The company sold its FDA-approved commercial product, the FC2 female condom, for $18 million, allowing it to focus exclusively on drug development [6][38] - The sale resulted in a loss of approximately $4.2 million, reflecting a change in strategy to concentrate on biopharmaceuticals [41][42] Market Data and Key Metrics Changes - The obesity program targets a significant market, with 22% of the U.S. population over 60 years old, and 41.5% of older adults classified as obese [9][10] - The Phase 2b QUALITY clinical study showed a 71% relative reduction in lean mass loss for patients receiving enobosarm plus semaglutide compared to placebo [12] Company Strategy and Development Direction - The company is advancing its drug development strategy for enobosarm and sabizabulin, focusing on cardiometabolic and inflammatory diseases [5][28] - Plans to request an end of Phase 2b meeting with the FDA and to run a similar study as a Phase III trial based on the successful Phase 2b results [25] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the top-line results from the Phase 2b QUALITY study, indicating potential for improved quality weight reduction and muscle preservation [21] - The independent data monitoring committee recommended continuing the study based on the unblinded safety data, indicating confidence in the ongoing clinical trials [23] Other Important Information - The company has sufficient cash to fund operations until the end of the calendar year, but additional capital will be needed to support drug development candidates [48][96] - The Phase 2b extension trial will evaluate whether enobosarm alone can maintain muscle and prevent fat regain after discontinuing GLP-1 receptor agonist therapy [24] Q&A Session Summary Question: What is the dropout rate for the extension trial? - The dropout rate is about 13%, primarily due to gastrointestinal side effects associated with GLP-1 receptor agonists [55] Question: What are the expectations for the extension trial data? - The focus is on whether enobosarm can minimize fat regain while maintaining muscle mass, with an emphasis on fat loss as the primary endpoint [64][66] Question: Will the full safety data be reported when the extension study results are released? - Yes, the full safety data set will be reported when the Phase 2b extension study is unblinded [114]