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    VERU
    Earnings call· Jun 2026(Q3 FY26)

    VERU Q3 FY26 earnings call VERU

    Aug 10, 2026 Source

    Executive summary

    Veru Q3 FY26 — Enobosarm Patent Allowance and PLATEAU Study Enrollment Complete

    Veru, a late clinical-stage biopharmaceutical company, is advancing its lead asset enobosarm for sarcopenic obesity, focusing on preserving lean mass and physical function in older patients receiving GLP-1 agonists. The company achieved a significant milestone with full enrollment of its Phase IIb PLATEAU study and secured a key method-of-use patent for enobosarm, while also establishing a supply agreement with Novo Nordisk. This quarter highlights strategic progress in clinical development and intellectual property, positioning enobosarm for a differentiated role in the expanding obesity market.

    Highlights

    5

    • Completed full enrollment of 239 patients for the Phase IIb PLATEAU clinical trial, on track for Q1 CY27 interim analysis.

    • Received a notice of allowance from the USPTO for a key method-of-use patent for enobosarm in combination with weight loss drugs, extending protection until at least October 3, 2044.

    • Secured a supply agreement with Novo Nordisk for Wegovy for the PLATEAU study, providing a direct channel to a major GLP-1 player.

    • Cash, cash equivalents, and restricted cash increased to $23.9 million as of June 30, 2026, from $15.8 million as of September 30, 2025.

    • Net working capital improved to $21.1 million as of June 30, 2026, from $11.1 million as of September 30, 2025.

    Concerns

    3

    • Net loss for Q3 FY26 was $7 million, compared to $7.3 million in the prior period.

    • Net loss for the 9 months ended June 30, 2026, was $15.1 million, compared to $24.2 million in the prior period.

    • Used cash of $20.6 million for operating activities during the 9 months ended June 30, 2026.

    Guidance & targets

    3
    CategoryTargetConfidence
    Phase IIb PLATEAU clinical study interim analysis results
    Results of 32-week interim analysis
    high materiality
    High
    Phase IIb PLATEAU clinical study final data
    Final data
    high materiality
    High
    Cash runway
    Sufficient to fund operations beyond interim analysis
    medium materiality
    High

    Operational metrics

    14
    Cash, cash equivalents and restricted cash
    $23.9 millioncompared to $15.8 million as of September 30, 2025
    as of June 30, 2026

    Includes $54,000 of restricted cash related to the sale of the FC2 Female Condom business.

    Net working capital
    $21.1 millioncompared to $11.1 million on September 30, 2025
    as of June 30, 2026
    Research and development costs
    $4.4 millionincreased from $3 million in the prior quarter
    Q3 FY26

    Primarily due to increased expenses related to the ongoing Phase IIb PLATEAU clinical study and wind down of Phase IIb quality clinical study.

    General and administrative expenses
    $3.4 milliondecreased from $5 million in the prior quarter
    Q3 FY26

    Primarily due to a decrease in share-based compensation and reduction in third-party consulting expenses.

    Research and development costs
    $8.8 milliondecreased from $12.7 million in the prior period
    9 months ended June 30, 2026

    Primarily due to wind down of the Phase IIb quality clinical study and reduced share-based compensation.

    General and administrative expenses
    $11.5 milliondecreased from $15.4 million in the prior period
    9 months ended June 30, 2026

    Primarily due to a decrease in share-based compensation and reduction in third-party consulting expenses.

    Gain on sale of ENTADFI assets
    $485,000
    Q3 FY26

    Based on nonrefundable consideration received related to promissory notes; no additional gain expected in future periods.

    Gain on extinguishment of debt (SWK Holdings royalty agreement)
    $8.6 million
    prior fiscal year (9 months ended June 30, 2025)

    Related to the termination of the SWK Holdings residual royalty agreement in conjunction with the sale of the FC2 Female Condom business.

    Increase in fair value of Onconetix equity securities
    $546,000
    Q3 FY26

    Due to realized gain from conversion of preferred stock and sale of common stock, and change in fair value of remaining warrants. Favorable antidilution provisions contributed.

    Increase in fair value of Onconetix equity securities
    $4.4 millioncompared to a loss of $0.3 million in the prior period
    9 months ended June 30, 2026

    Result of realized gain from conversion of preferred stock and sale of common stock, and change in fair value of remaining warrants. Favorable antidilution provisions contributed.

    Additional gain on sale of FC2 business (tax settlement)
    $351,000
    9 months ended June 30, 2026

    For net proceeds received from Clear Future in settlement of dispute related to pre-closing tax receivable and liability.

    Cash generated from investing activities
    $5.3 millioncompared to $18.9 million in the prior year period
    9 months ended June 30, 2026
    GLP-1 weight loss range
    15% to 28%
    null

    Range of weight loss achieved by current commercial GLP-1s from Novo Nordisk and Lilly.

    Fat loss selectivity
    100% fat
    null

    Target for enobosarm in combination with GLP-1s to achieve weight loss that is 100% fat while preserving and improving physical function.

    Industry KPIs

    6
    MetricValueDetails
    Pricing policy impactMedicare coverage for GLP-1 drugs
    Pipeline clinical milestonesPhase IIb PLATEAU clinical trial
    Regulatory approvals filingsNotice of Allowance for US patent
    Glp 1 incretin franchise metricsEnobosarm combination with GLP-1s
    Clinical trial efficacy safety dataPhase IIb Quality clinical study
    Business development capacity deal appetiteRight of first negotiation with Novo Nordisk

    Deals & partnerships

    2
    Novo NordiskSupply agreement for Wegovy for Phase IIb PLATEAU clinical trial.

    Veru is solely responsible for conducting and sponsoring the study. Novo Nordisk will supply Wegovy to Veru at no charge. Veru will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct.

    Clear FutureSale of FC2 Female Condom business.$16.3 million

    The sale occurred during the prior fiscal year. The tax settlement was recognized during the 9 months ended June 30, 2026.

    Risks & headwinds

    2
    Weight loss plateau with GLP-1sAfter 1 year of GLP-1 treatment

    88% of patients on GLP-1s hit a weight loss plateau after 1 year, with 62.6% still clinically obese.

    Mitigation: Enobosarm is being developed to break through this plateau by preserving muscle and burning fat.

    Lean mass loss and physical function decline with GLP-1sOngoing with GLP-1 treatment

    Up to 50% of weight loss is lean mass. 45% decline in stair climb power in patients over 60 on GLP-1 alone.

    Mitigation: Enobosarm is designed to preserve lean mass and physical function, augmenting fat loss.

    What to watch in Q4 FY26

    3

    Enobosarm Phase IIb PLATEAU interim analysis

    Q1 CY27
    CurrentFull enrollment of 239 patients completed.
    TargetResults of 32-week interim analysis.

    Why it matters

    This will provide the first look at enobosarm's longer-term effects on lean body mass, total fat mass, and potentially breaking the weight loss plateau in older patients on semaglutide.

    This puts us on track for a near-term milestone, which is reporting the results of the 32-week inter-analysis which is expected in Q1 calendar year 2027.

    Q&A highlights

    1

    How does the new patent for enobosarm with semaglutide broaden to cover other GLP-1s and future weight loss drugs, given the expanding market and delivery modes?

    Dr. Steiner explained the patent is significant as it's the first major breakthrough, establishing a method-of-use patent for enobosarm with semaglutide, covering various administration scenarios (concurrent, added to monotherapy, or after discontinuation). He noted that the patent applications are broad, covering 'weight loss drugs' beyond just GLP-1s, and that the company is prosecuting additional patents. He emphasized the importance of this initial patent for semaglutide given their current clinical development focus. He also highlighted that the market is moving towards Veru's focus on older patients with sarcopenic obesity, the near-term milestones for the PLATEAU study, and the strategic importance of the Novo Nordisk supply agreement.

    “So the first part is to elbow our way in to make sure that we had a method use path going forward in combination with the enobosarm or with enobosarm being given after a patient stops a GLP-1 because they want to be [indiscernible]. And so we're very, very broad in the patent applications to include all weight loss drugs.”

    asked by Leland Gershell · answered by Mitchell Steiner

    2 min read5 chapters

    Detailed Narrative

    01

    Enobosarm's Differentiated Mechanism for Obesity

    Enobosarm is an oral selective androgen receptor modulator (SARM) being developed to augment GLP-1 receptor agonists by promoting fat loss while preserving lean mass and physical function. This addresses the issue of non-selective weight loss with GLP-1s, where up to 50% of weight loss can be lean mass, particularly critical for older patients with sarcopenic obesity. The company emphasizes the goal of 'quality weight loss' to prevent physical function decline and bone density loss.

    02

    Addressing the GLP-1 Weight Loss Plateau

    Management highlighted that 88% of patients on GLP-1s hit a weight loss plateau after one year, with 62.6% still clinically obese. Enobosarm's mechanism, which directly burns fat and preserves muscle, is hypothesized to help break through this plateau by maintaining suppressed appetite and increased calorie burning, leading to incremental weight reduction. This positions enobosarm as a potential solution for patients who have stalled on GLP-1 monotherapy.

    03

    Strategic Patent Protection for Enobosarm

    Veru received a notice of allowance from the USPTO for a key U.S. patent application covering methods of use for enobosarm in combination with weight loss drugs, specifically semaglutide. This patent, expiring at least October 3, 2044, covers preservation of lean mass, enhancement of fat loss, improvement of physical function, bone preservation, insulin resistance, HbA1c, and prevention of weight/fat mass rebound. This broad protection is considered a significant breakthrough for the company's commercial prospects.

    04

    Financial Highlights and Liquidity

    The company reported a net loss of $7 million for Q3 FY26 and $15.1 million for the nine months ended June 30, 2026. R&D costs increased to $4.4 million in Q3 FY26 due to the PLATEAU study, while G&A expenses decreased to $3.4 million. The company's cash, cash equivalents, and restricted cash stood at $23.9 million as of June 30, 2026, up from $15.8 million at September 30, 2025. Net working capital improved to $21.1 million. Management stated that current cash is sufficient to fund operations beyond the interim analysis of the Phase IIb PLATEAU study.

    05

    Market Opportunity in Sarcopenic Obesity

    Veru is targeting older patients with sarcopenic obesity, a large market with 41.5% prevalence in patients 65 or older, representing over 20 million potential Medicare Part D enrollees. The improving reimbursement landscape for weight loss drugs under Medicare, effective July 1, 2026, for GLP-1s like Wegovy, further supports the commercial potential for a differentiated therapy like enobosarm.

    AI-generated summary of the company’s earnings call. Not investment advice.