Veru (NASDAQ:VERU – Get Free Report) posted its quarterly earnings data on Wednesday. The company reported ($0.26) earnings per share for the quarter, beating analysts’ consensus estimates of ($0.47) by $0.21, FiscalAI reports.
Here are the key takeaways from Veru’s conference call:
- FDA meeting gave regulatory clarity for enobosarm with two potential approval pathways (≥5% incremental placebo‑corrected weight loss at 52 weeks or demonstration of clinically meaningful preservation/improvement in physical function), and confirmed enobosarm 3 mg as an acceptable dose for development.
- Veru plans to start the double‑blind Phase 2b PLATEAU study this quarter in ~200 patients ≥65 years on semaglutide, with a 68‑week primary endpoint for percent change in body weight and an interim DEXA analysis of lean/fat mass at 34 weeks.
- The FDA’s Dec 2025 decision that total hip BMD by DEXA can be a validated surrogate endpoint could provide an alternate approval route for enobosarm in postmenopausal women on GLP‑1 therapy, and preclinical data show enobosarm increases BMD.
- Balance sheet improved after an October 2025 underwritten offering: net proceeds ~$23.4 million and cash, cash equivalents and restricted cash of $33.0 million, which management says should fund operations through the PLATEAU interim analysis.
- The company remains unprofitable with a Q1 net loss of $5.3 million (26¢/share), negative operating cash flow (used $6.2 million in the quarter), and continued development risk ahead of pivotal studies.
Veru Stock Down 2.6%
Shares of NASDAQ VERU opened at $2.24 on Friday. The firm has a market cap of $35.95 million, a PE ratio of -1.02 and a beta of -1.42. The company’s fifty day simple moving average is $2.42 and its 200 day simple moving average is $3.09. Veru has a 12-month low of $2.10 and a 12-month high of $7.40.
Institutional Trading of Veru
Key Veru News
Here are the key news stories impacting Veru this week:
- Positive Sentiment: Q1 beat and stronger cash position — Veru reported EPS of ($0.26) vs. consensus ($0.47) and cut operating losses vs. year-ago, while cash and equivalents rose to ~$33.0M (from $15.8M). Improved liquidity and a smaller loss reduce near-term financing pressure. MarketBeat Q1 results
- Positive Sentiment: Phase 2b PLATEAU trial to start this quarter — Veru plans a ~200‑patient, double‑blind study testing enobosarm + semaglutide in older adults with obesity, with an interim readout expected Q1 2027. Successful results could materially de‑risk the obesity program and create a clear combo‑therapy value proposition. Quiver Quant PLATEAU trial
- Positive Sentiment: FDA provided regulatory clarity — the agency indicated two potential approval pathways for enobosarm + GLP‑1: a ≥5% placebo‑corrected incremental weight loss at 52 weeks, or smaller weight differences paired with clinically meaningful preservation of physical function or improvements in bone mineral density (BMD). That guidance narrows regulatory risk vs. no-clearance scenarios. Yahoo — FDA feedback & earnings
- Neutral Sentiment: Positive Phase 2b QUALITY data provide proof‑of‑concept but were short‑term — QUALITY showed preservation of lean mass and greater fat loss in older patients on semaglutide, but weight differences were similar in the short active phase; longer trials are needed to confirm incremental weight benefit. Interim/longer follow‑up will determine commercial relevance. Yahoo earnings call summary
- Negative Sentiment: Still operating at a loss and dependent on future trial outcomes — Q1 net loss was ~$5.3M and the company remains pre‑commercial; approval hinges on meeting specific endpoints and successful Phase 2b/Phase 3 results. Continued losses or trial setbacks would pressure the stock. Business Insider Q1 release
- Negative Sentiment: Regulatory and execution risks remain — although FDA feedback is constructive, endpoints (weight, function, BMD) set a high bar and timelines (interim 2027) keep meaningful inflection points distant; small market cap and low volume amplify volatility. TipRanks commentary
Analyst Upgrades and Downgrades
A number of equities analysts recently commented on VERU shares. Weiss Ratings reaffirmed a “sell (e+)” rating on shares of Veru in a research note on Wednesday, January 21st. Wall Street Zen downgraded shares of Veru from a “hold” rating to a “sell” rating in a research note on Saturday, January 31st. Canaccord Genuity Group initiated coverage on shares of Veru in a report on Thursday, December 18th. They issued a “buy” rating and a $25.00 target price on the stock. Finally, Oppenheimer reiterated an “outperform” rating on shares of Veru in a report on Thursday, December 18th. Three research analysts have rated the stock with a Buy rating and one has given a Sell rating to the company’s stock. According to MarketBeat, the stock currently has an average rating of “Moderate Buy” and a consensus target price of $22.50.
Get Our Latest Stock Report on VERU
About Veru
Veru Inc is a clinical-stage biopharmaceutical company headquartered in Miami, Florida. The company is dedicated to the development and commercialization of novel therapies in the fields of oncology and infectious disease. Veru’s research strategy centers on advancing small-molecule and biologic candidates through clinical trials, leveraging its in-house manufacturing and formulation capabilities as well as strategic partnerships to support late-stage development.
The company’s lead product candidate is sabizabulin (VERU-111), an oral, microtubule-disrupting agent undergoing pivotal trials for indications that include metastatic castration-resistant prostate cancer and hospitalized patients with severe COVID-19.
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