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GRAIL Inc (GRAL)
NASDAQ:GRAL
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GRAIL Inc
(NASDAQ:GRAL)
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Rating:54Neutral
Price Target:
$51.00
▼(-4.19% Downside)
Action:ReiteratedDate:02/25/26
The score is driven by improving fundamentals and a solid balance sheet/cash runway, but remains capped by persistent losses and cash burn. Technically, the stock is in a pronounced downtrend (despite oversold readings), and valuation support is limited due to negative earnings and no dividend.
Positive Factors
Strong cash runway
A cash balance near $0.9B and stated runway into 2030 provides durable financial flexibility to fund commercialization, regulatory follow‑up and R&D without near‑term financing. This reduces execution risk and supports multi‑year investments in uptake and evidence generation.
Regulatory progress — PMA submitted
Submission of a PMA, backed by PATHFINDER 2 and NHS‑Galleri data and prior Breakthrough Device status, creates a credible pathway to formal FDA approval. A successful PMA would materially strengthen reimbursement prospects and long‑term commercial adoption across health systems.
Commercial momentum and improving unit economics
Sustained volume and revenue growth with rising adjusted gross profit indicate improving unit economics as scale increases. A path to 50%–60% gross margins at scale implies durable margin upside if growth continues and cost per test declines with scale.
Negative Factors
Missed NHS‑Galleri primary endpoint
Failing to meet the combined Stage III+IV endpoint creates durable regulatory and payer uncertainty: it may prompt additional FDA scrutiny, an advisory committee or extended evidence requirements, delaying reimbursement, guideline inclusion and broader clinical adoption.
Persistent operating losses and cash burn
Large, ongoing operating losses and negative free cash flow create structural financing risk over time. Even with current runway, continued burn necessitates future capital or material margin improvements; prolonged unprofitability can constrain investment and dilute shareholders.
Royalty headwind to future margins
Resumption of high single‑digit royalties in 2027 represents a permanent gross margin drag. This structural cost will reduce sustainable margin levels and cash conversion at scale, requiring higher prices or further cost reduction to preserve target profitability.
GRAIL Inc (GRAL) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$2.08B
Dividend YieldN/A
Average Volume (3M)1.57M
Price to Earnings (P/E)―
Beta (1Y)2.65
Revenue Growth20.53%
EPS Growth82.91%
CountryUS
Employees1,000
SectorHealthcare
Sector Strength45
IndustryMedical - Diagnostics & Research
Share Statistics
EPS (TTM)-2.44
Shares Outstanding38,982,224
10 Day Avg. Volume3,154,701
30 Day Avg. Volume1,572,755
Financial Highlights & Ratios
PEG Ratio0.09
Price to Book (P/B)1.22
Price to Sales (P/S)21.37
P/FCF Ratio-10.52
Enterprise Value/Market Cap0.93
Enterprise Value/Revenue13.07
Enterprise Value/Gross Profit-30.74
Enterprise Value/Ebitda-5.09
Forecast
1Y Price Target
$93.20Price Target Upside75.09% Upside
Rating ConsensusModerate Buy
Number of Analyst Covering5
EPS Forecast (FY)-11
Revenue Forecast (FY)$179.37M
GRAIL Inc Business Overview & Revenue Model
Company DescriptionGRAIL, Inc., a biotechnology company, focuses on developing technologies for early cancer detection. The company develops Galleri, a screening test for asymptomatic individuals over 50 years of age; and DAC, a diagnostic aid for cancer tests to accelerate diagnostic resolution for patients for whom there is a clinical suspicion of cancer. It is also developing minimal residual disease and other post-diagnostic tests. The company was incorporated in 2015 and is based in Menlo Park, California. GRAIL, Inc. operates as a former subsidiary of Illumina, Inc.
How the Company Makes MoneyGRAIL generates revenue primarily through the sale of its multi-cancer early detection tests to healthcare providers and institutions. The company's revenue model is driven by a combination of direct sales, partnerships with healthcare systems, and reimbursement strategies that allow patients to access testing through insurance coverage. Additionally, GRAIL may engage in collaborations with pharmaceutical companies for research and development, which can contribute to its earnings. The establishment of strategic partnerships with key players in the healthcare industry further enhances its market reach and potential revenue streams.
GRAIL Inc Earnings Call Summary
Earnings Call Date:Feb 19, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 19, 2026
Earnings Call Sentiment Positive
The call conveyed meaningful commercial momentum (36% volume growth, 26% U.S. revenue growth, expanded prescriber base), supportive safety and performance signals (fourfold detection rate increase, >20% Stage IV reduction in later rounds, no serious safety events), successful regulatory progress (PMA submitted) and a strong cash position. Offsetting these positives, the NHS‑Galleri trial missed its primary combined Stage III+IV endpoint, stage distribution anomalies require extended follow‑up (6–12 months), and the company still reports substantial operating losses and faces future royalty headwinds. On balance, the breadth of positive commercial, regulatory and clinical signals — plus improved profitability trends and a solid cash runway — outweigh the notable challenges and uncertainties.Q4-2025 Updates
Positive Updates
NHS-Galleri Top-Line Clinical Findings
Top-line NHS-Galleri results show a substantial reduction in Stage IV cancer diagnoses (greater than 20% reduction in rounds 2 and 3 for a prespecified group of 12 deadly cancers), increased detection of Stage I and II cancers, a fourfold higher overall cancer detection rate versus standard of care, and fewer cancers detected via emergency presentation; no serious safety concerns reported across ~70,000 participants over 3 rounds.
PATHFINDER 2 Registrational Consistency
Full PATHFINDER 2 results from 35,000 participants are consistent with prior data from the first 25,000 presented at ESMO, supporting test performance and clinical validation used in regulatory submission.
Completed PMA Submission to FDA
GRAIL completed its PMA submission to the FDA (final module submitted end of January) for Galleri, supported by PATHFINDER 2 and NHS-Galleri data; FDA previously designated the test a Breakthrough Device (2018) and a ~12-month review period is anticipated.
Commercial Volume and Revenue Growth
U.S. Galleri test volume grew 36% in 2025 to more than 185,000 tests; U.S. Galleri revenue grew 26% to $136.8 million; total 2025 revenue was $147.2 million, up 17% YoY; Q4 2025 revenue was $43.6 million, up 14% YoY; sold >57,000 tests in Q4 and ~0.5 million tests since launch.
Expansion of Prescriber Base and Go‑to‑Market Investment
Prescriber base increased to ~17,000 providers, up 30% YoY; company announced planned expansion of field sales and medical teams to accelerate commercial momentum.
Medicare Coverage Pathway Established
Federal law (Nancy Gardner Sewell Medicare MCED Screening Coverage Act) enacted, creating a Medicare pathway for FDA‑approved multi‑cancer early detection (MCED) tests — a structural positive for future reimbursement.
Improving Unit Economics and Profitability Trends
Non‑GAAP adjusted gross profit for Q4 2025 was $23.1 million (+29% YoY) and full‑year adjusted gross profit was $73.6 million (+27% YoY); Q4 adjusted EBITDA loss improved to -$71.8 million (15% improvement YoY) and full‑year adjusted EBITDA loss improved to -$320.6 million (34% improvement YoY); reiterated long‑term gross margin target of 50%–60% at scale.
Strong Cash Position and Guidance
Cash balance of $904.4 million as of Dec 31, 2025 (cash runway into 2030); reiterated 2026 guidance of Galleri sales growth of 22%–32% and 2026 cash burn not to exceed $300 million.
Negative Updates
Primary Endpoint Missed in NHS‑Galleri
The NHS‑Galleri trial did not meet its primary endpoint: a statistically significant reduction in combined Stage III and IV cancers was not observed (combined Stage III+IV reduction not statistically significant).
Mixed Stage Distribution and Higher‑than‑Expected Stage II Incidence
Investigators observed a higher‑than‑anticipated incidence of Stage II cancers and an increase or lack of reduction in Stage III in the trial, complicating the combined endpoint and prompting plans to extend follow‑up by 6–12 months to mature data.
Regulatory and Payer Uncertainty Despite PMA Submission
Although PMA submitted, the missed primary endpoint introduces potential uncertainty for regulators and payers (possibility of FDA advisory committee and further scrutiny of clinical utility), and management acknowledged continuing discussions with FDA/CMS will be required.
Ongoing Operating Losses
Adjusted EBITDA remained negative: Q4 -$71.8 million and full‑year -$320.6 million (improvements YoY but still substantial losses); net loss Q4 $99.2 million (+2% YoY) and full‑year net loss $408.4 million (improved 80% YoY but still sizable).
Decline in Development Services Revenue
Development services revenue decreased 49% YoY to $8.6 million for full year 2025 (Q4 development services revenue of $1.3 million), reflecting lower demand or a shift in revenue mix.
Potential Future Royalty Impact on Margins
Per supply agreement with Illumina, royalty payments (suspended through Dec 2026) will resume thereafter at an expected high single‑digit percentage of oncology net sales in perpetuity, which is expected to negatively impact gross margins beginning in 2027.
Need for Additional Follow‑Up and Data Maturation
Company plans to extend follow‑up by 6–12 months to better assess effects; this extension delays definitive interpretation of trial impact on combined stage shift and may delay downstream payer and guideline decisions.
Company Guidance
On the call GRAIL reiterated guidance for 2026 of Galleri sales growth of 22%–32% and cash burn of no more than $300 million, noted a cash position of $904.4 million (cash runway into 2030) and reminded investors of a ~12‑month FDA PMA review timeline; they also highlighted 2025 results including total revenue $147.2M (+17% YoY) with U.S. Galleri revenue $136.8M (+26%), Q4 revenue $43.6M (+14%), >57,000 tests sold in Q4 and >185,000 tests sold in 2025 (nearly 0.5M tests sold since launch), a ~17,000 prescriber base (+30%), Q4 non‑GAAP adjusted gross profit $23.1M (+29%) and full‑year $73.6M (+27%), adjusted EBITDA of –$71.8M in Q4 (improved 15%) and –$320.6M for FY (improved 34%), a long‑term gross‑margin target of 50%–60% at scale, Illumina royalties suspended until Dec 2026 then expected in the high single digits, and supportive clinical readouts (NHS‑Galleri top‑line: >20% reduction in Stage IV in rounds 2–3, a fourfold higher cancer detection rate, no serious safety concerns in ~70,000 tested; PATHFINDER 2: 35,000 participant results consistent with earlier 25,000).GRAIL Inc Financial Statement Overview
Summary
Balance sheet strength (low leverage and sizable equity) and a meaningful 2025 gross margin turnaround support the score, but it is constrained by deep ongoing losses and consistently negative operating/free cash flow with substantial burn.Income Statement
Revenue is scaling quickly off a small base (up ~3.8x in 2025 vs. 2024 after strong growth in prior years), and 2025 shows a meaningful improvement in gross profitability (about 50% gross margin vs. negative gross margin in 2021–2024). However, the business remains deeply unprofitable: 2025 net loss is still roughly 2.8x revenue, and operating losses remain substantial despite improving versus 2024’s extremely large loss year. Overall, strong top-line momentum and improving unit economics are outweighed by persistently heavy losses.22
Negative
Balance Sheet
The balance sheet looks relatively strong from a leverage standpoint, with low debt levels versus equity across the period (debt-to-equity around ~1%–3% historically). Equity remains sizable (~$2.6B in 2025), providing financial flexibility. The key weakness is poor profitability translating into negative returns on shareholder capital in prior years (and still ongoing losses), which could pressure the balance sheet over time if losses persist.78
Positive
Cash Flow
Cash generation remains a clear weak spot. Operating cash flow and free cash flow are consistently negative, with 2025 burn still near $299M and free cash flow declining versus 2024. While cash burn improved materially from 2023–2024 levels, the company is still funding operations through external capital rather than internally generated cash, which increases financing risk if capital markets tighten.30
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 147.17M | 125.59M | 93.11M | 55.55M | 14.61M |
| Gross Profit | -62.57M | -78.02M | -95.61M | -116.45M | -100.00M |
| EBITDA | -377.82M | -610.17M | -638.22M | -587.70M | -1.21B |
| Net Income | -408.35M | -2.03B | -1.47B | -5.40B | -1.25B |
Balance Sheet | |||||
| Total Assets | 2.92B | 2.98B | 4.56B | 5.60B | 9.74B |
| Cash, Cash Equivalents and Short-Term Investments | 904.43M | 763.47M | 97.29M | 241.60M | 221.16M |
| Total Debt | 98.01M | 68.14M | 84.41M | 96.01M | 110.56M |
| Total Liabilities | 344.15M | 479.90M | 910.74M | 955.94M | 307.40M |
| Stockholders Equity | 2.58B | 2.50B | 3.65B | 4.65B | 9.43B |
Cash Flow | |||||
| Free Cash Flow | -299.01M | -582.36M | -608.69M | -584.17M | -758.06M |
| Operating Cash Flow | -299.01M | -577.16M | -595.80M | -561.31M | -688.13M |
| Investing Cash Flow | -85.05M | -551.01M | -12.89M | -22.86M | 344.81M |
| Financing Cash Flow | 423.32M | 1.24B | 463.77M | 604.82M | 394.74M |
GRAIL Inc Technical Analysis
Negative
53.23
Price Trends
93.26
Negative
89.94
Negative
64.89
Negative
Market Momentum
-11.69
Positive
34.26
Neutral
17.64
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For GRAL, the sentiment is Negative. The current price of 53.23 is below the 20-day moving average (MA) of 87.75, below the 50-day MA of 93.26, and below the 200-day MA of 64.89, indicating a bearish trend. The MACD of -11.69 indicates Positive momentum. The RSI at 34.26 is Neutral, neither overbought nor oversold. The STOCH value of 17.64 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for GRAL.
GRAIL Inc Risk Analysis
GRAIL Inc disclosed 76 risk factors in its most recent earnings report. GRAIL Inc reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
GRAIL Inc Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
73 Outperform | $28.78B | -136.70 | -29.02% | ― | 38.17% | -28.77% | |
59 Neutral | $20.56B | 24.61 | 33.36% | ― | -2.39% | ― | |
54 Neutral | $2.08B | -4.76 | -16.07% | ― | 20.53% | 82.91% | |
54 Neutral | $12.32B | -28.33 | ― | ― | 30.38% | 24.17% | |
52 Neutral | $1.28B | -11.65 | -12.42% | ― | 10.10% | -44.29% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
48 Neutral | $431.07M | -1.17 | -68.45% | ― | 0.21% | -233.51% |
* Healthcare Sector Average
GRAL
GRAIL Inc
53.23
16.90
46.52%
ILMN
Illumina
134.46
50.26
59.69%
MYGN
Myriad Genetics
4.61
-5.78
-55.63%
NEO
NeoGenomics
9.83
0.25
2.61%
NTRA
Natera
208.04
64.93
45.37%
GH
Guardant Health
93.90
53.16
130.49%
GRAIL Inc Corporate Events
Business Operations and StrategyFinancial DisclosuresRegulatory Filings and Compliance
GRAIL Reports Strong 2025 Growth and Galleri Trial Update
Positive
Feb 19, 2026
On Feb. 19, 2026, GRAIL reported that 2025 total revenue rose 17% year on year to $147.2 million, driven by a 26% increase in U.S. Galleri sales to $136.8 million, while net loss narrowed sharply to $408.4 million and adjusted EBITDA improved 34%. The company sold more than 185,000 Galleri tests in 2025, ended the year with $904.4 million in cash and securities, and said its balance sheet supports operations into 2030.
GRAIL also announced top-line results from the large randomized NHS-Galleri trial in England, where adding Galleri to standard cancer screening did not achieve the primary endpoint of statistically reducing combined Stage III–IV cancers but did substantially cut Stage IV diagnoses and increase early Stage I–II detection. The company completed analysis of the 35,000-participant PATHFINDER 2 study with performance consistent with earlier data, finished the final module of its FDA premarket approval submission for Galleri in January, and stands to benefit from new U.S. federal law establishing a Medicare coverage pathway for multi-cancer early detection tests.
The most recent analyst rating on (GRAL) stock is a Hold with a $114.00 price target. To see the full list of analyst forecasts on GRAIL Inc stock, see the GRAL Stock Forecast page.
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.