Veru (VERU)
NASDAQ:VERU
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Veru
(NASDAQ:VERU)
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Rating:46Neutral
Price Target:
$2.50
▲(2.46% Upside)
Action:ReiteratedDate:02/12/26
The score is held down primarily by weak financial performance (minimal revenue, large losses, and continued cash burn) and a bearish technical setup (below key moving averages with negative MACD). The main offset is a relatively positive earnings call with clearer FDA/regulatory pathways and improved liquidity from the recent financing, though long timelines and potential additional funding needs remain key risks.
Positive Factors
Regulatory clarity from FDA
Clear FDA guidance on acceptable endpoints and dose materially lowers regulatory execution risk. Having two viable approval pathways (≥5% incremental weight loss or functional/BMD benefit) lets management design trials to target realistic, clinically meaningful outcomes and improves long-term predictability.
Negative Factors
Persistent negative cash generation
Sustained negative operating and free cash flow combined with negligible commercial revenue indicate the business remains development-stage and capital intensive. Continued cash burn without recurring product sales increases reliance on external financing, pressuring long-term sustainability absent strong clinical progress or partnering.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory clarity from FDA
Clear FDA guidance on acceptable endpoints and dose materially lowers regulatory execution risk. Having two viable approval pathways (≥5% incremental weight loss or functional/BMD benefit) lets management design trials to target realistic, clinically meaningful outcomes and improves long-term predictability.
Read all positive factors
Veru (VERU) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$35.95M
Dividend YieldN/A
Average Volume (3M)51.53K
Price to Earnings (P/E)―
Beta (1Y)0.69
Revenue Growth-100.00%
EPS Growth48.16%
CountryUS
Employees210
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-1.21
Shares Outstanding16,050,320
10 Day Avg. Volume60,069
30 Day Avg. Volume51,535
Financial Highlights & Ratios
PEG Ratio0.04
Price to Book (P/B)3.04
Price to Sales (P/S)0.00
P/FCF Ratio-1.85
Enterprise Value/Market Cap0.17
Enterprise Value/Revenue24.04
Enterprise Value/Gross Profit-51.45
Enterprise Value/Ebitda-0.59
Forecast
1Y Price Target
$25.00Price Target Upside924.59% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)-1.19
Revenue Forecast (FY)N/A
Veru Business Overview & Revenue Model
Company Description
Veru Inc., an oncology biopharmaceutical company, focuses on developing medicines for the management of cancers. Its commercial products comprise FC2 female condom/internal condom for the dual protection against unintended pregnancy and the transm...
How the Company Makes Money
Veru’s business model is primarily research-and-development driven, with revenue historically coming from (i) net product revenue from any marketed products it sells and (ii) other income such as licensing, collaboration, or royalty-related arrang...
Veru Earnings Call Summary
Earnings Call Date:Feb 11, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:May 13, 2026
Earnings Call Sentiment Positive
The call conveyed multiple substantive positives: a supportive FDA meeting clarifying development pathways, positive Phase 2b proof-of-concept data for Novosarm, an attractive BMD surrogate endpoint opportunity, a planned Phase 2b PLATO study with defined endpoints, and improved liquidity after a $23.4M financing that increased cash to ~$33M and materially improved working capital and operating expense trends. Offsetting risks include the company remaining unprofitable, reliance on cash through the interim analysis (creating near-term financing risk), conditional regulatory approval criteria if incremental weight loss is under 5%, nonrecurring prior-period gains, and long timelines to meaningful readouts (interim not expected until 2027). Overall, the highlights and strengthened balance sheet and regulatory clarity meaningfully outweigh the lowlights, but execution and further financing remain key risks.Positive Updates
Positive Phase 2b Proof-of-Concept Results
Completed a positive Phase 2b 'quality' clinical trial in 168 older patients showing Novosarm combined with a GLP-1 receptor agonist produced greater loss of fat mass while preserving lean mass and physical function, and reduced weight/fat regain after semaglutide discontinuation.
Negative Updates
Company Remains Unprofitable with Historical Negative Cash Flow
Despite improvements, Veru is not profitable and has experienced negative cash flow from operations historically; ongoing R&D and clinical development will continue to require capital beyond current milestones if timelines or costs change.
Read all updates
Q1-2026 Updates
Positive
Negative
Positive Phase 2b Proof-of-Concept Results
Completed a positive Phase 2b 'quality' clinical trial in 168 older patients showing Novosarm combined with a GLP-1 receptor agonist produced greater loss of fat mass while preserving lean mass and physical function, and reduced weight/fat regain after semaglutide discontinuation.
Read all positive updates
Company Guidance
The company said the FDA provided two acceptable regulatory paths for Novosarm: either at least a 5% placebo‑corrected incremental weight‑loss difference at 52 weeks, or, if incremental weight loss is <5%, a statistically significant, clinically meaningful preservation/improvement in physical function (e.g., Stair Climb) could support approval; the FDA also confirmed Novosarm 3 mg as an acceptable dose. Veru plans a ~200‑patient Phase 2b PLATO in patients ≥65 years with BMI ≥35 initiating semaglutide, with a primary endpoint of percent change in total body weight at 68 weeks and an interim DEXA analysis of lean and fat mass at 34 weeks (interim anticipated in 2027); key secondaries include total fat mass, total lean mass, Stair Climb (loaded/unloaded, duplicate runs), total hip BMD by DEXA, patient‑reported function, HbA1c and insulin resistance. Context: prior Phase 2b quality study enrolled 168 older patients and ~1,000 patients have been assessed with StairClimb across Novosarm studies; GLP‑1s can cause up to 50% of weight loss to be lean mass, 88% of patients hit a GLP‑1 weight‑loss plateau at 1 year (Cervant1) with 62.6% still clinically obese, and SELECT (n>17,000) reported 4–5x more hip/pelvic fractures on semaglutide in females and patients ≥75 (relevant to FDA’s Dec 19, 2025 qualification of total hip BMD by DEXA as a surrogate in postmenopausal osteoporosis). Financially, Veru completed an Oct 31, 2025 offering (1.4M shares, pre‑funded warrants for up to 7.0M shares, Series A and B warrants for up to 8.4M shares each) raising net ≈$23.4M, had $33.0M cash and $29.7M net working capital as of Dec 31, 2025, used $6.2M cash in operations in the quarter, and expects cash to fund operations through the planned interim analysis.Veru Financial Statement Overview
Summary
Income Statement
14
Very Negative
Balance Sheet
58
Neutral
Cash Flow
18
Very Negative
| Breakdown | TTM | Sep 2025 | Sep 2024 | Sep 2023 | Sep 2022 | Sep 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 247.06K | 0.00 | 16.89M | 16.30M | 39.35M | 61.26M |
| Gross Profit | -115.43K | -152.10K | 5.85M | 7.57M | 30.59M | 47.93M |
| EBITDA | -10.05M | -35.38M | -36.20M | -89.98M | -79.23M | 9.75M |
| Net Income | -19.11M | -22.73M | -37.80M | -93.15M | -83.78M | 7.39M |
Balance Sheet | ||||||
| Total Assets | 47.57M | 29.84M | 60.42M | 50.02M | 135.36M | 178.15M |
| Cash, Cash Equivalents and Short-Term Investments | 35.40M | 18.32M | 24.92M | 9.63M | 80.19M | 122.36M |
| Total Debt | 2.98M | 3.12M | 13.86M | 14.41M | 15.88M | 13.74M |
| Total Liabilities | 10.44M | 11.50M | 28.10M | 30.34M | 52.56M | 25.85M |
| Stockholders Equity | 37.12M | 18.33M | 32.32M | 19.68M | 82.80M | 152.29M |
Cash Flow | ||||||
| Free Cash Flow | -24.88M | -30.04M | -21.84M | -88.68M | -48.24M | -15.95M |
| Operating Cash Flow | -24.88M | -30.04M | -21.68M | -88.01M | -47.51M | -15.57M |
| Investing Cash Flow | 7.90M | 25.14M | 146.21K | 6.33M | 4.27M | 14.62M |
| Financing Cash Flow | 23.37M | -4.22M | 36.83M | 11.11M | 1.07M | 109.72M |
Veru Technical Analysis
Positive
2.44
Price Trends
2.40
Positive
2.42
Positive
3.19
Negative
Market Momentum
0.02
Negative
53.88
Neutral
51.27
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For VERU, the sentiment is Positive. The current price of 2.44 is above the 20-day moving average (MA) of 2.34, above the 50-day MA of 2.40, and below the 200-day MA of 3.19, indicating a neutral trend. The MACD of 0.02 indicates Negative momentum. The RSI at 53.88 is Neutral, neither overbought nor oversold. The STOCH value of 51.27 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for VERU.
Veru Risk Analysis
Veru disclosed 58 risk factors in its most recent earnings report. Veru reported the most risks in the "Finance & Corporate" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Veru Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
53 Neutral | $38.02M | -1.39 | -171.01% | ― | -100.00% | 13.12% | |
52 Neutral | $113.94M | 5.20 | -165.19% | ― | 195.75% | 58.21% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
47 Neutral | $194.77M | -0.32 | 77.87% | ― | 0.57% | -76.41% | |
46 Neutral | $35.95M | -2.04 | -83.24% | ― | -100.00% | 48.16% | |
42 Neutral | $25.47M | -0.31 | 763.31% | ― | -51.03% | -35.20% |
* Healthcare Sector Average
VERU
Veru
2.24
-2.80
-55.56%
KPTI
Karyopharm Therapeutics
8.64
2.63
43.76%
CUE
Cue Biopharma
35.00
11.61
49.64%
INMB
Inmune Bio
1.43
-5.54
-79.48%
CELU
Celularity
0.88
-0.79
-47.37%
JUNS
Jupiter Neurosciences, Inc.
0.33
-0.29
-46.45%
Veru Corporate Events
Business Operations and StrategyExecutive/Board ChangesShareholder Meetings
Veru Shareholders Expand Equity Plan, Reelect Board Leadership
Neutral
Mar 13, 2026
At its 2026 Annual Meeting of Shareholders held on March 12, 2026, Veru Inc. won investor approval to significantly expand its 2018 Equity Incentive Plan, more than doubling the pool of common shares available for awards from 2.6 million to 5.85 m...
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.