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Veru Inc (VERU)
NASDAQ:VERU
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Veru
(NASDAQ:VERU)
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Rating:46Neutral
Price Target:
$2.50
▼(-4.58% Downside)
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
FDA regulatory clarity
Clear FDA guidance on acceptable endpoints and an agreed dose materially reduces regulatory execution risk. Over the medium term this enables a more predictable PLATO trial design, informs statistical planning and endpoint selection, and strengthens the company's ability to negotiate partnerships and plan resource allocation.
Positive Phase 2b proof‑of‑concept
Demonstrated clinical proof‑of‑concept in a relevant older population lowers the scientific risk profile. Preservation of lean mass and function when combined with GLP‑1s strengthens the mechanistic thesis, supports meaningful endpoints for confirmatory studies, and increases the probability of successful late‑stage development or partner interest.
Improved liquidity and working capital
A material capital infusion substantially improved the balance sheet and near‑term runway, reducing immediate financing pressure. This durable cash buffer supports planned PLATO execution to interim readout, enables stable trial operations, and gives management time to pursue partnerships or structured funding with less forced dilution.
Negative Factors
Weak cash generation
Persistent negative operating and free cash flow is a critical structural weakness for a clinical‑stage biotech. Ongoing burn requires repeated capital raises, which dilute shareholders and can constrain R&D strategy. Weak cash generation also limits flexibility to expand programs or respond to adverse trial outcomes without external financing.
Limited funding horizon
A runway that extends only to an interim DEXA analysis creates a material near‑term financing cliff. If additional cash is needed to complete the 68‑week trial or scale next steps, the company will likely face dilutive financings or hurried partnerships, elevating execution and capital‑access risk over the coming 6–18 months.
Conditional regulatory approval criteria
Approval hinges on meeting specific incremental weight‑loss or functional/BMD thresholds, adding outcome conditionality. This increases trial complexity, may require larger or longer studies to power secondary endpoints, and raises the chance that results fall short of prespecified criteria, impacting the timeline and probability of approval.
Veru (VERU) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$42.05M
Dividend YieldN/A
Average Volume (3M)85.78K
Price to Earnings (P/E)―
Beta (1Y)0.27
Revenue Growth-100.00%
EPS Growth55.10%
CountryUS
Employees210
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.26
Shares Outstanding16,050,320
10 Day Avg. Volume49,587
30 Day Avg. Volume85,778
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 Cap0.29
Enterprise Value/Revenue50.03
Enterprise Value/Gross Profit-107.08
Enterprise Value/Ebitda-1.23
Forecast
1Y Price Target
$25.00Price Target Upside854.20% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering2
EPS Forecast (FY)-2.12
Revenue Forecast (FY)N/A
Veru Business Overview & Revenue Model
Company DescriptionVeru 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 transmission of sexually transmitted infections for ministries of health, government health agencies, U.N. agencies, nonprofit organizations, and commercial partners. The company's development drug candidates include Enobosarm, an oral selective androgen receptor agonist that is in phase III clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; Sabizabulin, which is phase IIb clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; Enobosarm + abemaciclib combination therapy, which is in phase III clinical trial for the treatment of AR+ ER+ HER2- metastatic breast cancer; and Sabizabulin + enobosarm combination therapy, an oral targeted cytoskeleton disruptor plus selective androgen receptor agonist, which is in phase II clinical trial for the treatment of metastatic triple negative breast cancer. Its drug candidates also comprise Sabizabulin, which is in Phase II clinical trial for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer; VERU-100, a GnRH antagonist peptide injection, which is in Phase II clinical trial for the treatment of advanced hormone sensitive prostate cancer; Zuclomiphene Citrate, which is in Phase II clinical trial for treating hot flashes; and Sabizabulin, which is in phase III clinical trial for the treatment of SARS-CoV-2 in subjects at high risk for acute respiratory distress syndrome. In addition, the company is advancing a new drug formulation for the treatment of men with lower urinary tract symptoms from an enlarged prostate. The company was formerly known as The Female Health Company and changed its name to Veru Inc. in July 2017. Veru Inc. was incorporated in 1971 and is headquartered in Miami, Florida.
How the Company Makes MoneyVeru generates revenue primarily through the commercialization of its pharmaceutical products, which includes sales from its approved therapies. The company also engages in research and development partnerships with other pharmaceutical companies, which can provide additional funding and resources in exchange for shared rights to new drugs. Additionally, Veru may receive milestone payments and royalties from licensing agreements related to its drug candidates. The ongoing development of its pipeline products and successful clinical trials are critical to expanding its revenue streams.
Veru Earnings Call Summary
Earnings Call Date:Feb 11, 2026
(Q1-2026)
| % Change Since: |
Next Earnings Date:May 07, 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.Q1-2026 Updates
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.
Regulatory Clarity from Successful FDA Meeting
September 2025 FDA meeting provided clear development pathways for Novosarm in combination with a GLP-1 receptor agonist: (1) ≥5% placebo-corrected incremental weight loss at 52 weeks or (2) <5% incremental weight loss but demonstration of clinically meaningful preservation/improvement in physical function. FDA also confirmed Novosarm 3 mg as an acceptable dose for development.
New Validated BMD Surrogate Endpoint Opportunity
FDA announcement (Dec 19, 2025) that total hip BMD by DEXA is a validated surrogate endpoint in postmenopausal osteoporosis is directly relevant; Novosarm has preclinical data showing anabolic and anti-resorptive effects on bone, enabling a potential BMD-based approval pathway in postmenopausal women on GLP-1 therapy.
PLATO Phase 2b Trial Initiation and Design
Planned double-blind, placebo-controlled Phase 2b PLATO study to enroll ~200 patients ≥65 years with BMI ≥35 initiating semaglutide; primary endpoint is percent change in total body weight at 68 weeks with an interim DEXA-based analysis at 34 weeks for lean/fat mass. Principal investigator named; study expected to begin this quarter.
Successful Capital Raise Strengthening Cash Position
Completed an underwritten public offering on Oct 31, 2025, raising net proceeds of approximately $23.4M (common stock, pre-funded warrants and Series A/B warrants).
Improved Liquidity and Working Capital
Cash, cash equivalents, and restricted cash increased to $33.0M from $15.8M as of Sep 30, 2025 (approximately +109%). Net working capital rose to $29.7M from $11.1M (approximately +168%). Management states cash is expected to fund operations through the PLATO interim analysis.
Operating Expense and Loss Improvements
R&D expenses decreased to $1.3M from $5.7M (≈77% decrease) due to wind-down of the prior Phase 2b study. General & administrative expenses declined to $4.1M from $5.2M (≈21% decrease). Net loss improved to $5.3M ($0.26 per diluted share) from $8.9M ($0.61) in the prior-year quarter (≈40% improvement). Operating cash used decreased to $6.2M from $11.3M (≈45% reduction).
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.
Funding Horizon Limited to Interim Analysis
Management states current cash is expected to fund operations only through the interim DEXA analysis in the PLATO study, indicating potential near-term financing needs to complete the full 68-week trial and later phases if results require further work.
Regulatory Approval Pathways Conditional and Uncertain
FDA acceptance is conditional: a clear path exists for ≥5% incremental placebo-corrected weight loss at 52 weeks, but if incremental weight loss is <5%, approval would rely on demonstrating clinically meaningful functional or BMD benefits. This conditionality introduces regulatory risk depending on trial outcomes.
Previous One-Time Gains Not Recurring
Prior-period gains (e.g., $8.6M gain on extinguishment of debt, $695k sale-related gain, and proceeds from FC2 divestiture) materially supported past results but are nonrecurring, so prior favorable comparisons may not continue.
Clinical Landscape Challenge: GLP-1 Treatment Plateau
Industry-wide challenge: 88% of patients on GLP-1s hit a weight-loss plateau at one year and 62.6% remain clinically obese at plateau, underscoring both a therapeutic need and competitive/regulatory complexity for demonstrating meaningful incremental benefit.
Long Timelines to Interim Readout
Interim DEXA analysis is not expected until 2027, meaning extended timelines before key data and potential value inflection points; lack of futility or sample-size re-estimation at interim could prolong exposure to development risk.
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
Overall financial profile is weak: minimal TTM revenue with negative gross profit, very large losses, and significant ongoing cash burn (TTM operating cash flow/free cash flow around -$24.9M). The balance sheet is a partial offset with improved leverage (low debt-to-equity) and rebuilt equity, but negative ROE and persistent cash-flow deficits keep financial risk elevated.Income Statement
Profitability has deteriorated sharply. TTM (Trailing-Twelve-Months) revenue is minimal (about $0.25M) and gross profit is negative, indicating the core cost structure is not currently supported by sales. Losses are very large, with TTM net margin deeply negative, and the company has been unprofitable for four straight annual periods after a profitable 2021. The main positive is that prior-year revenue (2024) was materially higher than TTM, suggesting the current run-rate may reflect disruption or a step-down rather than a stable base.14
Very Negative
Balance Sheet
Leverage looks manageable, with low debt relative to equity in TTM (debt-to-equity ~0.08), improving meaningfully versus 2023 (~0.73). Equity has also rebuilt versus 2025 annual levels, providing a better capital cushion. The key weakness is persistently negative returns on equity (TTM roughly -0.83), meaning the balance sheet is being eroded by ongoing losses despite the lighter debt load.58
Neutral
Cash Flow
Cash generation is weak: TTM (Trailing-Twelve-Months) operating cash flow and free cash flow are both around -$24.9M, and free cash flow declined versus the prior period (negative growth). While cash burn improved substantially from 2023’s very large outflow, the company remains meaningfully cash-flow negative, which can increase financing risk if losses persist.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 | 32.99M | 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
2.62
Price Trends
2.43
Positive
2.74
Negative
3.76
Negative
Market Momentum
0.04
Negative
57.33
Neutral
80.58
Negative
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 2.62 is above the 20-day moving average (MA) of 2.45, above the 50-day MA of 2.43, and below the 200-day MA of 3.76, indicating a neutral trend. The MACD of 0.04 indicates Negative momentum. The RSI at 57.33 is Neutral, neither overbought nor oversold. The STOCH value of 80.58 is Negative, 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 |
|---|---|---|---|---|---|---|---|
54 Neutral | $175.92M | -0.58 | ― | ― | -3.98% | -29.94% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
51 Neutral | $35.36M | -0.62 | -155.77% | ― | 19.05% | 2.01% | |
46 Neutral | $42.05M | ― | -60.25% | ― | -100.00% | 55.10% | |
44 Neutral | $34.61M | -0.36 | ― | ― | -15.81% | -113.06% | |
42 Neutral | $25.76M | -0.62 | -195.19% | ― | -25.51% | 49.72% |
* Healthcare Sector Average
VERU
Veru
2.62
-2.39
-47.70%
KPTI
Karyopharm Therapeutics
9.59
2.34
32.28%
CUE
Cue Biopharma
0.28
-0.92
-76.50%
INMB
Inmune Bio
1.33
-6.41
-82.82%
CELU
Celularity
1.20
0.03
2.56%
JUNS
Jupiter Neurosciences, Inc.
0.51
-0.07
-12.76%
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.