Veru (NasdaqCM:VERU) Q1 2026 Earnings call February 11, 2026 08:00 AM ET Company ParticipantsGary Barnette - Chief Scientific OfficerMichele Greco - CFO and Chief Administrative OfficerMitchell Steiner - Chairman, CEO, and PresidentRohan Mathur - Biopharma Equity Research AssociateSam Fisch - Executive Director of Investor Relations and Corporate CommunicationsConference Call ParticipantsEdward Nash - Managing Director and Senior Biotechnology AnalystOperatorThis event is being recorded. I would now like to ...

Veru (NasdaqCM:VERU) Q1 2026 Earnings call February 11, 2026 08:00 AM ET Speaker4This event is being recorded. I would now like to turn the conference call over to Mr. Sam Fisch, Veru Inc.'s Executive Director, Investor Relations and Corporate Communications. Please go ahead.Speaker6Good morning. 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 ...

MIAMI, FL, Feb. 04, 2026 (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 Wednesday, February 11, 2026, at 8:00 a.m. ET to discuss its fiscal 2026 first quarter financial results and to provide a business update. The audio webcast will be accessible under the Home page and Investors page of ...

Financial Data and Key Metrics Changes - The net loss from continuing operations for fiscal year 2025 was $15.7 million, or $1.07 per diluted common share, compared to a net loss of $35.3 million, or $2.61 per diluted common share in the prior year [30] - Research and development costs increased to $15.6 million in fiscal 2025 from $12.8 million in the prior year, primarily due to expenses related to the Phase 2b obesity clinical study for enobosarm [28] - Selling, general and administrative expenses decreased to $19.9 million in fiscal 2025 from $24.6 million in the prior year, mainly due to a reduction in share-based compensation expenses [28] Business Line Data and Key Metrics Changes - The company sold the FC2 Female Condom business for $18 million in cash, resulting in net proceeds of approximately $16.5 million after adjustments, which allowed the company to focus exclusively on drug development [24][26] - The gain on the sale of ENTADFI assets was $10.8 million in fiscal 2025, compared to a gain of $1.2 million in the prior year [28] Market Data and Key Metrics Changes - The company reported a cash balance of $15.8 million as of September 30, 2025, down from $24.9 million as of September 30, 2024 [31] - The company generated cash from investing activities of $25.1 million for fiscal 2025, compared to $0.1 million from investing activities in the prior year [32] Company Strategy and Development Direction - The company is focusing on developing enobosarm as a muscle-preserving agent in combination with GLP-1 receptor agonists to enhance fat loss while preserving lean mass, particularly targeting older patients with obesity [5][19] - The planned Phase 2b PLATEAU clinical trial aims to assess the ability of enobosarm to break through the weight loss plateau in patients with a BMI greater than 35 and age greater than or equal to 65 [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the evolving regulatory landscape for muscle-preservation drugs and the potential for multiple pathways to approval based on clinical outcomes [17][19] - The company highlighted the importance of addressing the weight loss plateau experienced by many patients on GLP-1 receptor agonists, indicating a significant market opportunity [18][50] Other Important Information - The company completed a public offering on October 31, 2025, resulting in net proceeds of approximately $23.4 million, which will support ongoing clinical studies [27][23] - The company reported a loss on the sale of the FC2 Female Condom business of approximately $4.1 million, impacting the financial results for the year [25][31] Q&A Session Summary Question: Will any GLP-1 be allowed in your Phase 2b, or will it be limited to just tirzepatide? - Management indicated that they will choose one GLP-1 receptor agonist to avoid variability in the study, with tirzepatide currently as the placeholder [40] Question: How does the FDA's guidance affect the transition from Phase 2 to Phase 3? - Management clarified that the Phase 2b study is designed to mirror Phase 3 conditions, allowing for a clear understanding of incremental weight loss and functional endpoints [43] Question: What patient population is being targeted in the PLATEAU study? - Management explained that the focus is on patients over 65 with physical limitations, as this group is most in need and will provide informative data for the study [46][49]

Core Insights - The company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA, indicating that incremental weight loss is an acceptable primary endpoint for approval [1][10] - The Phase 2b PLATEAU clinical study is planned to start in Q1 2026, focusing on older patients with obesity [1][12] - The company completed a public offering post fiscal year end, raising approximately $23.4 million [1][19] Clinical Development - The Phase 2b QUALITY study demonstrated that enobosarm, when combined with GLP-1 RA, selectively promotes fat loss while preserving lean mass and physical function in older patients [4][17] - The FDA has confirmed that enobosarm 3 mg is an acceptable dosage for future clinical development [11] - The Phase 2b PLATEAU study will evaluate the effects of enobosarm on body weight, physical function, and safety in patients aged 65 and older with a BMI of 35 or higher [12][13] Financial Performance - For fiscal year 2025, research and development expenses increased to $15.6 million from $12.8 million, while general and administrative expenses decreased to $19.9 million from $24.6 million [14] - The operating loss from continuing operations decreased to $24.8 million from $36.2 million [14] - The net loss from continuing operations decreased to $15.7 million, or $1.07 per share, compared to $35.3 million, or $2.61 per share in the previous year [19]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company will host a conference call on December 17, 2025, to discuss its fiscal year 2025 financial results and provide a business update [1] Company Overview - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making GLP-1 RA drugs more tissue-selective for fat loss while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm combined with semaglutide led to greater fat loss and preservation of lean mass in older patients [4] - The upcoming Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [5] - The primary efficacy endpoint of the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [1] - The company announced multiple presentations at the SCWD 18 International Conference and the Regulatory Workshop in Rome, Italy [1] Presentation Details - Mitchell Steiner, Veru Inc.'s Chairman, President & CEO, will present "The Veru Experience" on December 12, 2025, from 4:30 pm to 4:45 pm Central European Time [2] - Another presentation by Mitchell Steiner titled "Enobosarm" will take place on December 13, 2025, from 10:00 am to 10:15 am Central European Time [2] Regulatory Workshop Insights - The Regulatory Workshop will cover treatment approaches to address muscle wasting in obesity therapy, including comments from industry representatives and regulatory considerations from EMA and FDA [3] - A discussion on possible endpoints for regulatory approval of treatments addressing muscle wasting will also be held, featuring various industry approaches including Veru's [4][5] Drug Development Focus - Veru's drug development program includes two late-stage novel small molecules: enobosarm and sabizabulin [6] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction while preserving lean mass during GLP-1 RA treatment [6] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [6] Clinical Study Updates - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [7] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients with obesity [8] - The primary efficacy endpoint for the PLATEAU study is the percent change from baseline in total body weight at 72 weeks, with an interim analysis at 36 weeks [8][9]

Core Insights - Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for cardiometabolic and inflammatory diseases [3] - The company announced the presentation of two abstracts at ObesityWeek 2025, highlighting its drug enobosarm's potential in weight management [1][2] Company Overview - Veru Inc. is developing two late-stage novel small molecules: enobosarm and sabizabulin [3] - Enobosarm is a selective androgen receptor modulator (SARM) aimed at enhancing weight reduction by making fat loss more tissue-selective while preserving lean mass [3] - Sabizabulin is being developed for treating inflammation in atherosclerotic cardiovascular disease [3] Clinical Studies - The Phase 2b QUALITY clinical study demonstrated that enobosarm, when combined with semaglutide, led to greater fat loss while preserving lean mass in older patients [4] - The study involved 168 older patients (≥60 years) and showed that while weight loss was similar across treatment groups, the preservation of lean mass is expected to enhance energy expenditure [4] - A planned Phase 2b PLATEAU clinical study will evaluate enobosarm's effect on total body weight and physical function in approximately 200 patients initiating GLP-1 RA treatment [5][6] - The primary efficacy endpoint for the PLATEAU study is the percent change in total body weight at 72 weeks, with an interim analysis at 36 weeks [5][7]

Core Points - Veru Inc. announced a public offering of 1,400,000 shares of common stock, pre-funded warrants for 7,000,000 shares, and Series A and B warrants for 8,400,000 shares each, with a combined offering price of $3.00 per share [1][2] - The gross proceeds from the offering are expected to be approximately $25.2 million, with potential additional proceeds of about $50.4 million if all warrants are exercised [2] - The net proceeds will primarily fund the development of enobosarm, particularly for the Phase 2b PLATEAU clinical study, and will also cover working capital and general corporate purposes [3] Offering Details - The offering includes common stock, pre-funded warrants, and Series A and B warrants, all sold by Veru under a previously filed shelf registration statement [4] - The offering is expected to close on or about October 31, 2025, pending customary closing conditions [1] Company Overview - Veru Inc. is a late clinical stage biopharmaceutical company focused on innovative medicines for cardiometabolic and inflammatory diseases [6]

Core Viewpoint - Veru Inc. has initiated an underwritten public offering of its common stock and related warrants to fund the development of its drug enobosarm, particularly for the Phase 2b PLATEAU clinical study [1][2]. Group 1: Offering Details - The public offering includes shares of common stock, pre-funded warrants, Series A warrants, and Series B warrants, all offered by Veru [1][3]. - The offering is subject to market conditions, and there is no guarantee regarding its completion or the terms [1]. - Canaccord Genuity LLC and Oppenheimer & Co. Inc. are the joint book-running managers for this offering [2]. Group 2: Use of Proceeds - The net proceeds from the offering will primarily support the Phase 2b PLATEAU clinical study activities for enobosarm [2]. - Additional proceeds will be allocated for working capital, existing vendor obligations, and general corporate purposes, including collaboration with potential development partners for enobosarm [2]. Group 3: Regulatory Information - The offering is conducted under a shelf registration statement on Form S-3, which was filed with the SEC on March 16, 2023, and declared effective on April 14, 2023 [3]. - A preliminary prospectus supplement will be filed with the SEC and will be accessible on the SEC's website [3].