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olivLaw · US equity research

GRAIL, Inc. GRAL

Services-Medical Laboratories · SIC 8071 · Vertical: Services-Medical Laboratories (SIC 8071)

133.76USD−6.74% · 1 dayClose 02 Nov 2026

GRAIL is a healthcare company developing Galleri, a blood test that screens for many cancer types from a single sample and indicates the organ of origin. The company submitted its PMA application to the FDA in January 2026, while commercial sales keep growing, with over 117000 Galleri tests sold in the first half of 2026.

At the close of 02 Nov 2026, GRAIL, Inc. (GRAL) stock was 133.76 USD (−6.74% on the day), with market capitalisation 6.0 bn USD, beta 2.65, 52-week range 43.03–158.92 USD. Latest reported quarter (Q2 2026): revenue of 44.7 m USD (+25.7% YoY), net income of -110.2 m USD, diluted EPS -2.56 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
6.0 bn USD
shares as of 03 Aug 2026
P/E (TTM)
unavailable
Diluted EPS TTM -9.75 · TTM to 30 Jun 2026
E/P (TTM)
-7.29%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
2.65
Volatility (1y) 111%
52-week range
43.03158.92

Price history

Loading chart…

Technical reading

RSI (14)
51.2
neutral
Bollinger (20, 2)
116.39 – 157.40
in the lower half of the band · %B 0.42 · band width 30.0%
SMA 50 / 200
113.07 / 78.24
uptrend (price > SMA50 > SMA200)
MACD (12, 26, 9)
8.19 / 8.92
MACD below signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month−6.6%−2.3%−4.3 pp—
3 months+90.4%−0.8%+91.1 pp—
6 months+140.3%+4.7%+135.6 pp—
Year to date+56.3%+10.2%+46.1 pp—
1 year+45.5%+10.3%+35.3 pp−11.7%
3 yearsunavailable+73.0%unavailable+63.9%
5 yearsunavailable+61.8%unavailable—
Max drawdown (1y)
−62.9%
22 Jan 2026 → 23 Feb 2026
Max drawdown (5y)
−62.9%
22 Jan 2026 → 23 Feb 2026
Compound annual growth (5y)
unavailable
S&P 500 +10.1%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
44.7 m USD
+25.7% YoY
Net income
-110.2 m USD
unavailable YoY
Diluted EPS
-2.56
unavailable YoY
net / operating
-246.7% / -388.9%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Revenue28.7 m38.3 m31.8 m35.5 m36.2 m43.6 m40.8 m44.7 m
Research & development78.2 m48.3 m53.6 m46.6 m48.6 m46.9 m48.0 m47.4 m
Operating income-183.5 m-136.9 m-153.6 m-158.9 m-125.3 m-124.4 m-135.8 m-173.8 m
Pre-tax income-172.4 m-127.0 m-146.4 m-152.9 m-118.7 m-116.5 m-127.5 m-166.7 m
Income tax-46.7 m-29.9 m-40.2 m-38.9 m-29.7 m-17.3 m-34.3 m-56.5 m
Net income-125.7 m-97.1 m-106.2 m-114.0 m-89.0 m-99.2 m-93.2 m-110.2 m
Diluted EPS-3.94-2.89 ≈-3.10-3.18-2.46-2.44 ≈-2.29-2.56
Operating cash flow-104.6 m ≈-93.5 m-95.0 m-77.0 m ≈-63.2 m ≈-63.8 m-87.0 m-80.7 m ≈
Capex971.0 k ≈303.0 k62.0 k369.0 k ≈384.0 k ≈94.0 k503.0 k432.0 k ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year2022202320242025
Revenue55.6 m93.1 m125.6 m147.2 m
Revenue YoYunavailable+67.6%+34.9%+17.2%
Net income-5.4 bn-1.5 bn-2.0 bn-408.4 m
Net income YoYunavailableunavailableunavailableunavailable
Diluted EPS-173.89-47.21-63.54-11.11
Diluted EPS YoYunavailableunavailableunavailableunavailable
net %-9,719.3%-1,574.2%-1,613.9%-277.5%
Free cash flow-584.2 m-608.7 m-582.4 m-299.9 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
249.7 m USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
2.6 bn USD
Total assets
2.9 bn USD
Debt / equity
unavailable
Current ratio
11.97x
ROE
-16.1%
ROA
-13.8%
FCF margin
-203.8%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
93.1 m
2024
125.6 m
2025
147.2 m

SEC (XBRL)· 12 Mar 2026verified

Research & development
2023
338.7 m
2024
322.4 m
2025
195.8 m

SEC (XBRL)· 12 Mar 2026verified

Operating income
2023
-1.5 bn
2024
-2.2 bn
2025
-562.2 m

SEC (XBRL)· 12 Mar 2026verified

Pre-tax income
2023
-1.5 bn
2024
-2.2 bn
2025
-534.5 m

SEC (XBRL)· 12 Mar 2026verified

Income tax
2023
-42.0 m
2024
-135.4 m
2025
-126.2 m

SEC (XBRL)· 12 Mar 2026verified

Net income
2023
-1.5 bn
2024
-2.0 bn
2025
-408.4 m

SEC (XBRL)· 12 Mar 2026verified

Diluted EPS
2023
-47.21
2024
-63.54
2025
-11.11

SEC (XBRL)· 12 Mar 2026verified

Weighted average diluted shares
2023
31.0 m
2024
31.9 m
2025
36.8 m

SEC (XBRL)· 12 Mar 2026verified

Balance sheet · USD

Cash
2023
97.3 m
2024
214.2 m
2025
249.7 m

SEC (XBRL)· 12 Mar 2026verified

Receivables
2023
16.9 m
2024
20.3 m
2025
18.3 m

SEC (XBRL)· 12 Mar 2026verified

Current assets
2023
156.1 m
2024
819.9 m
2025
953.8 m

SEC (XBRL)· 12 Mar 2026verified

Property, plant & equipment, net
2023
85.0 m
2024
69.1 m
2025
51.8 m

SEC (XBRL)· 12 Mar 2026verified

Goodwill
2023
888.9 m
2024
0
2025
—

SEC (XBRL)· 05 Mar 2025verified

Intangibles (excl. goodwill)
2023
2.7 bn
2024
2.0 bn
2025
1.9 bn

SEC (XBRL)· 12 Mar 2026verified

Total assets
2023
3.9 bn
2024
3.0 bn
2025
2.9 bn

SEC (XBRL)· 12 Mar 2026verified

Accounts payable
2023
19.7 m
2024
4.8 m
2025
2.1 m

SEC (XBRL)· 12 Mar 2026verified

Current liabilities
2023
163.6 m
2024
76.9 m
2025
79.7 m

SEC (XBRL)· 12 Mar 2026verified

Total liabilities
2023
267.6 m
2024
479.9 m
2025
344.2 m

SEC (XBRL)· 12 Mar 2026verified

Equity
2023
—
2024
2.5 bn †
2025
2.6 bn †

SEC (XBRL)· 12 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-595.8 m
2024
-577.2 m
2025
-299.0 m

SEC (XBRL)· 12 Mar 2026verified

Capex
2023
12.9 m
2024
5.2 m
2025
909.0 k

SEC (XBRL)· 12 Mar 2026verified

Free cash flow
2023
-608.7 m ≈
2024
-582.4 m ≈
2025
-299.9 m ≈

SEC (XBRL)· 12 Mar 2026derived

Investing cash flow
2023
-12.9 m
2024
-551.0 m
2025
-85.0 m

SEC (XBRL)· 12 Mar 2026verified

Financing cash flow
2023
463.8 m
2024
1.2 bn
2025
423.3 m

SEC (XBRL)· 12 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
17.2%
computed by olivLawFY 2025
Revenue CAGR 3Y
38.4%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
input data missing
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
-338.4%
computed by olivLawTTM to 30 Jun 2026
Net margin
-236.9%
computed by olivLawTTM to 30 Jun 2026
FCF margin
-179.2%
computed by olivLawTTM to 30 Jun 2026

Returns

ROE
-16.1%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-14.1%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
input data missing
ROCE
-20.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
unavailable
input data missing

Liquidity

Current ratio
10.9x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
unavailable
input data missing
Cash ratio
0.7x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-294.7 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
1.4 m USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-296.2 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
40 days
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
6.0 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-7.3%
computed by olivLawTTM to 30 Jun 2026
P/B
2.3x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
36.2x
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-5.0%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 4 of at least 6
  • score weight coverage: 27.1% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

133.76 USD

02 Nov 2026Source: olivLaw, closing series

Market cap: 6.0 bn USD

Key indicators

Market capitalisation
6.0 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
2.3x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
ROE
-16.1%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
-236.9%
computed by olivLawTTM to 30 Jun 2026
Revenue growth (YoY)
17.2%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

24/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 03 Aug 2026
Source: SEC (XBRL)published 06 Aug 2026
verified 377derived 28

Score by group

27% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · input data missing
  • Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Services-Medical Laboratories (SIC 8071)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality-236.9%13 (vs peers)23%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth38.4%100 (on a fixed band)31%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet10.9x100 (on a fixed band)15%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-5.0%0 (on a fixed band)31%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partial100/100 · 1/2 factors with a value
  • Quality· partial13/100 · 1/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

GRAIL, Inc. (GRAL). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 147.2 m USD in 2025; YoY growth 17.2%; net margin -236.9%; ROE -16.1%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Revenue CAGR 3Y: 38.4%
  • Current ratio: 10.9x

What contradicts it

  • Net margin: -236.9%
  • FCF yield: -5.0%

Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Services-Medical Laboratories (SIC 8071) · same industry (4-digit SIC) · compared with 23 companies

Multiples and returns vs the median

P/E
—
vertical median 35.0x
EV/EBITDA
—
vertical median 17.2x
P/S
36.2x
vertical median 3.0x
above median (+1,110.1%)
P/B
2.3x
vertical median 3.1x
below median (−23.0%)
ROE
-16.1%
vertical median -9.1%
below median
Net margin
-236.9%
vertical median -7.1%
below median
EBIT margin
-338.4%
vertical median -11.8%
below median
Revenue YoY
17.2%
vertical median 13.8%
above median (+24.4%)
Net debt/EBITDA
—
vertical median 2.5x
Dividend yield
—
vertical median 0.8%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
NTRANatera, Inc.54.6 bn—-12.5%-7.1%+35.9%+59% / +577%
LHLabcorp Holdings Inc.28.9 bn29.211.4%6.9%+7.2%+32% / +64%
DGXQuest Diagnostics Inc27.6 bn25.015.2%9.5%+11.8%+33% / +83%
GHGuardant Health, Inc.22.9 bn——-38.3%+32.9%+57% / +578%
CAICaris Life Sciences, Inc.9.1 bn86.720.1%10.6%+97.0%+26% / unavailable
GRALGRAIL, Inc.6.0 bn—-16.1%-236.9%+17.2%+46% / unavailable
RDNTRadNet, Inc.5.8 bn—-2.1%-0.9%+11.5%−12% / +120%
CDNACaredx, Inc.4.5 bn35.933.0%25.9%+13.8%+381% / +784%
VCYTVeracyte, Inc.3.9 bn35.08.8%20.4%+16.0%+4% / +91%
FTREFortrea Holdings Inc.1.9 bn—-12.3%-2.6%+1.0%+58% / −32%
PSNLPersonalis, Inc.1.7 bn—-50.3%-153.8%−17.7%+47% / +930%
BLLNBillionToOne, Inc.1.2 bn148.826.3%9.5%+100.0%−15% / unavailable
CSTLCastle Biosciences, Inc.1.1 bn—-4.2%-5.4%+3.7%−13% / +75%
FLGTFulgent Genetics, Inc.530.8 m—-8.0%-26.0%+13.8%−35% / −30%
YDESYD Bio Limited422.6 m—-445.1%-1,392.6%+16.9%−48% / unavailable
BDSXBiodesix, Inc.229.8 m—-540.0%-27.0%+24.1%+163% / −27%
XGNExagen Inc.203.3 m—-113.8%-26.6%+19.7%+6% / +356%
SERASera Prognostics, Inc.58.3 m—-45.0%-47,475.7%+5.2%−40% / +3%
AMSAmerican Shared Hospital Services8.3 m—-7.5%-5.8%−0.9%−42% / −47%
MDXHMdxhealth SA8.1 m—-2,440.4%-31.1%+19.8%−96% / −95%
ACONAclarion, Inc.5.2 m—-59.0%-10,978.5%+65.6%−71% / −100%
ADVBAdvanced Biomed Inc.3.4 m0.484.8%5,231.3%unavailable−75% / unavailable
BGLCBioNexus Gene Lab Corp.2.9 m—-33.7%-82.4%−21.9%−78% / −89%
BNRBurning Rock Biotech Limited0—-10.1%-10.3%+9.2%−53% / +21%

1- and 3-year price returns: for GRAL from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

Bear
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (USD)

Estimated priceBearBaseBull
1 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
3 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
5 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
What moves the 3-year price the most

    AI analysis

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    In brief

    GRAIL is a healthcare company developing Galleri, a blood test that screens for many cancer types from a single sample and indicates the organ of origin. The company submitted its PMA application to the FDA in January 2026, while commercial sales keep growing, with over 117000 Galleri tests sold in the first half of 2026 2.

    SWOT

    Strengths

    • The company holds one of the largest clinical data sets in genomic medicine, drawn from multiple studies 1. Galleri has rising revenue and commercial volume that grows quarter over quarter 3.
    • Partnerships with health systems, employers and insurers provide diversified distribution channels 13. The PATHFINDER 2 studies showed a substantial increase in cancers detected through screening 3.
    • The company has sufficient liquidity for operations, with cash and short-term securities reported as of June 30, 2026 3.

    Weaknesses

    • Net losses are significant and persistent since inception, and gross profit is negative 13. The company expects to keep incurring operating losses over the coming years 2.
    • Galleri has not yet received FDA approval and Medicare coverage is not available 1. Commercialisation still depends on the laboratory test rather than an approved product.
    • The NHS-Galleri trial did not meet its primary endpoint, which could affect clinical perception and negotiations with payers 1.

    Opportunities

    • FDA approval and inclusion in USPSTF guidelines could open broad coverage by commercial and public insurers 1. A Medicare coverage timeline is provided in law 1.
    • The Samsung partnership could facilitate launch in South Korea and other Asian markets, subject to approvals 2. Single-payer health systems could follow the NHS model 1.
    • Results showing fewer late-stage cancers and more early-stage detection could support economic arguments for adoption 13.

    Threats

    • If the FDA does not approve the PMA or approves with narrow indications, the commercial outlook could change significantly 1. The timing of approval is uncertain.
    • Reliance on outside financing and share issuances could dilute shareholders if losses remain high 1. The company used an ATM programme and private placements during the past year 1.
    • Real-world results differing from study results could weaken confidence among clinicians and payers 1.

    Risks

    • FDA approvalhigh

      Galleri is not approved and the PMA application is under review. If approval does not come or comes with narrow indications, commercial development could be affected 12.

    • NHS-Galleri resultshigh

      The trial did not meet its primary endpoint. If payer and clinician perception remains negative, coverage and adoption could be delayed 1.

    • Losses and funding needmedium

      The company records net losses and needs capital for research and commercialisation. If financing becomes more costly, plans could be scaled back 12.

    • Laboratory processingmedium

      The move to an industrial-scale version of the test caused delays and added costs. If problems persist, performance and reputation could be affected 1.

    • International operationslow

      The Samsung partnership depends on regulatory approvals and further conditions. If these are delayed, expansion in Asia could be postponed 2.

    Investment thesis

    What would need to be true (bull case)

    • Galleri sales growth in both the quarter and the first half shows expanding commercial demand 23. If FDA approval comes, coverage could become broad 1.
    • Clinical studies showed a substantial rise in cancers detected through screening, and the early-stage results support the public health argument 3.
    • Partnerships with Samsung and health plans could extend access to new markets, subject to conditions 23.

    What would break the thesis

    • Net losses remain large, gross profit is negative, and the company expects losses to continue 13.
    • The NHS trial did not meet its primary endpoint, which could limit coverage and adoption in public systems 1.
    • Without FDA approval, Galleri remains a laboratory test, and the commercial timeline depends on a decision that is still uncertain 12.

    What to watch

    • FDA advisory committee decision on the PMA applicationfall 2026
    • Final NHS-Galleri trial results and the NHS decisionmid-2026
    • Quarterly Galleri test volume and testing revenue trendQ3 2026
    • Implementation of the Medicare MCED law and the CMS decision2029

    Products, market & competition

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    The business

    GRAIL, Inc. (Nasdaq: GRAL) states its mission as detecting cancer early, when it can be cured 1. Its main product, Galleri, is a multi-cancer test that detects DNA fragments shed into the bloodstream by tumour cells and predicts the organ or tissue of origin. The company was spun off from Illumina in June 2024 1.

    Galleri is sold as a laboratory developed test (LDT) in the United States but has not been approved or cleared by the FDA. The PMA application, filed in January 2026, was accepted for review, and the company anticipates an FDA advisory committee in the fall 23. Galleri test revenue grew 24% in the second quarter of 2026 3.

    The business depends on clinical study results. The NHS-Galleri trial did not meet its primary endpoint of a statistically significant combined reduction in stage 3 and 4 cancers, but it did show a reduction in stage 4 diagnoses 12. The company has invested heavily in research and development, and net losses remain significant 1.

    Segments

    Galleri commercial screening

    The Galleri test is sold to health systems, employers, digital health platforms, insurers and life insurance providers. In the first half of 2026, Galleri revenue reached 82.5 million dollars, and test volume grew 42% 3. Total company revenue in the second quarter was 44.7 million dollars 3.

    Development services and partnerships

    The company also earns development services revenue and partnership income. The Samsung partnership for South Korea and possibly other Asian markets could extend international distribution, subject to regulatory approvals 2.

    Market context

    The market for multi-cancer early detection tests is new and not yet broadly covered. The company says more than 70% of cancer deaths come from cancers without recommended screening 1. A new law from February 2026 creates a Medicare coverage category for these tests, with coverage possible from 2029 1.

    Adoption depends on FDA approval, the NHS decision in the United Kingdom and possible inclusion in USPSTF guidelines. If FDA approval is obtained, the company intends to pursue inclusion in USPSTF recommendations, though this may take several years 1.

    Trends

    • Medicare coverage framework for multi-cancer teststailwind

      The February 2026 law could allow Medicare coverage of approved or cleared tests if CMS issues a national coverage determination 1. The timing depends on the CMS process, which could be delayed or more restrictive.

    • Pressure from clinical study resultsheadwind

      The NHS-Galleri results, without meeting the primary endpoint, could influence the views of clinicians, payers and regulators 1. The company is continuing to analyse the data and could extend follow-up by 6-12 months 1.

    • Growth in commercial salestailwind

      Galleri test volume grew 35% in the second quarter of 2026, supported by an expanded sales force and partnerships with health plans 23. Continued growth could reduce reliance on outside financing.

    • Operating costs and lossesmixed

      Net losses and a negative gross profit keep pressure on the balance sheet 13. If volume grows without lowering processing costs, losses could persist.

    Competitive position

    The sources reviewed do not explicitly name direct competitors. The company does describe standard USPSTF-recommended screenings for breast, cervical, colorectal, lung and prostate cancer as the existing alternative that Galleri would add to 1. It states it is the only MCED test with extensive validation from interventional studies 3.

    The company's differentiation rests on targeted methylation analysis, large clinical studies and international agreements. If other multi-cancer test developers obtain comparable data, competitive pressure could rise 1.

    • Standard USPSTF single-cancer screening tests

      Screening for breast, cervical, colorectal, lung and prostate cancer is the existing alternative that Galleri is meant to complement 1.

    • Other multi-cancer test developers

      The sources do not identify them. Potential competitors could emerge if comparable results are published.

    • Public health systems

      The UK NHS decides whether to implement Galleri; other single-payer systems could follow the same model 1.

    • Symptom-based clinical diagnosis

      Late diagnosis once symptoms appear remains the predominant practice, which the company treats as a public health problem 1.

    News & filings

    In the press

    SEC filings

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / GRAIL, Inc. · 12 Mar 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / GRAIL, Inc. · 06 Aug 2026
    3. [3] Form 8-K, results release (exhibit 99.1) · SEC / GRAIL, Inc. · 05 Aug 2026

    Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.

    GRAIL, Inc. (GRAL): stock, results, valuation and forecast · olivLaw