Grail, Inc. · NASDAQ:GRAL
Grail — Investor Day (November 2025)
54 slides from Grail's investor day presentation, Nov 13, 2025
Slide 1: GRAIL Analyst Day
GRAIL Analyst Day November 13, 2025 1
Slide 2: Forward-looking statements
This presentation contains forward-looking statements. In some cases, you can identify these statements by forward-looking words such as “aim,” “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “should,” “would,” or “will,”
Slide 3: Detect cancer early, when it can be cured.
Detect cancer early, when it can be cured. 3
Slide 4: Welcome and Introduction agenda
Welcome and Introduction Bob Ragusa Business Review Aaron Freidin & Dr. Josh Ofman PATHFINDER 2 Results Dr. Nima Nabavizadeh NHS-Galleri Study Review Professor Peter Sasieni Q&A International Opportunity Sir Harpal Kumar Commercial Business Review Andy Partridge Customer Panel Q&A 4
Slide 5: Business Review
Business Review Aaron Freidin Chief Financial Officer Josh Ofman President 5
Slide 6: GRAIL at a Glance
GRAIL at a Glance 1st ~420k >16k To market with an MCED test Commercial Galleri tests sold Galleri prescribers $125M 50-60% >725k Clinical and commercial tests 2024 revenue Target gross margin at scale completed >1M test capacity ~$850M Significant opportunity to scale further at RTP site Cash as of
Slide 7: Financial Profile is Strengthening
Financial Profile is Strengthening Revenue Cash Burn Revenue by Quarter ($M) Cash Burn by Quarter ($M) $120.0 $40.0 $38.3 $105.2 $35.5 $36.2 $30.0 $31.8 $80.0 $88.9 $86.8 Cash burn $28.7 Revenue $71.8 $20.0 $59.0 $40.0 $10.0 $0.0 $0.0 Q3 2024 Q4 2024 Q1 2025 Q2 2025 Q3 2025 Q3 2024 Q4 2024 Q1 2025 Q
Slide 8: Margin Profile Improves with Volume
Margin Profile Improves with Volume Non-GAAP Adjusted Gross Profit Laboratory test volume1 $ in thousands Q3 2024 Q3 2025 75k Gross Loss $ (22,233) $ (13,733) ~66k Amortization of intangible assets 33,473 33,473 50k Stock-based compensation 578 271 ~42k 25k Adjusted Gross Profit $11,818 $20,011 Adju
Slide 9: The Impact Of Cancer Is Immense In The US
The Impact Of Cancer Is Immense In The US Cancer is the most feared 1 in 3 people will be diagnosed with disease1 cancer in their lifetime 3 And is the second leading cause of death in the US2 1 in 6 people will die from cancer 3 1. Vrinten C, et al. Psychooncology. 201 7; 26(8):1 070-107 9. DO I: 1
Slide 10: Our Clinical Programs are Leading the Field
Our Clinical Programs are Leading the Field 1 2 3 4 5 6 Exploratory Clinical Assay Case Control Prospective Randomized Prospective Development Study Screening Studies Control Studies Real World Study & Validation Discovery Analytical Clinical Clinical Performance Clinical Utility Performance in Vali
Slide 11: Consistently Strong Performance in Interventional and Real-World Studies
Consistently Strong Performance in Interventional and Real-World Studies Foundational Studies PPV Real-World Experience of MCED PPV Commercial Dana Farber experience Cancer CCGA3 PATHFINDER PATHFINDER 2 REFLECTION Mayo Clinic >100,000 Institute Clinical Validation Intended-Use Intended-Use Veterans
Slide 12: Adding Galleri to Standard of Care May Identify More Cancers More Efficiently
Adding Galleri to Standard of Care May Identify More Cancers More Efficiently Combining SoC screenings with Galleri, the cost to diagnose one cancer is The majority of Galleri detected cancers have no reduced by an estimated 65% recommended screening tests ~332k cancers with no CANCERS FALSE recomme
Slide 13: PMA Submission to FDA Anticipated in Q1 2026
PMA Submission to FDA Anticipated in Q1 2026 PATHFINDER-2 Performance and safety data from first ~25,000 individuals with one year of follow up NHS-Galleri Data from the intervention arm from the prevalent round of screening Bridging Study Provides comparison between the version of Galleri used in t
Slide 14: Results from the PATHFINDER 2 Study
Results from the PATHFINDER 2 Study Nima Nabavizadeh, MD Associate Professor, Radiation Medicine Chief Medical Officer, CEDAR Knight Cancer Institute, Oregon Health & Science University Portland, OR 14
Slide 15: Disclosures
Disclosures GRAIL, Inc.: Advisory board member MJH Life Sciences: Writing engagement Quattro Consulting: Market research consulting Roche: Invited speaker 15
Slide 16: PATHFINDER 2: Largest Interventional MCED Study Conducted in the US to Date
PATHFINDER 2: Largest Interventional MCED Study Conducted in the US to Date Prospective, interventional study of an MCED test including 35,878 participants from 32 North American healthcare systems with 3 years of follow-up1-2,a Diagnostic CANCER resolutiona,c IDENTIFIED CANCER SIGNAL DETECTED NO CA
Slide 17: Enrolled a Diverse Patient Population That Reflects Intended Use Population
Enrolled a Diverse Patient Population That Reflects Intended Use Population Baseline Demographics and Characteristicsd Median Age (IQR), years 65 (59-71) Consented Age Groups (With ≥12 Months of Follow-Up) Data cutoff December 31, 2024 50-59 years 27.0% n=25,578 60-69 years 44.4% • Data not cleaned,
Slide 18: Observed PPV Was ~62% Across All Cancers
Observed PPV Was ~62% Across All Cancers 1 Cancer Status Over 12 Months of Follow-up (Performance Analyzable Cohort) Cancer No Cancer Total Performance Diagnosis Diagnosis (n=23,161) Metric (95% CI) Cancer Signal (n=329) (n=22,832) PPV MCED Test Positive 133 83 216 61.6% (54.9-67.8%) Detection Rate
Slide 19: Observed PPV Was ~62% Across All Cancers
Observed PPV Was ~62% Across All Cancers 1 Cancer Status Over 12 Months of Follow-up (Performance Analyzable Cohort) Cancer No Cancer Total Performance Diagnosis Diagnosis ● MCED test PPV ranged from (n=23,161) Metric (95% CI) (n=329) (n=22,832) 42.9%-49.4% in prior clinical PPV studies and real-wor
Slide 20: Robust 12-Month Episode Sensitivity in Clinically Relevant Subgroups
Demonstrated Robust 12-Month Episode Sensitivity in Clinically Relevant Subgroups Episode Sensitivity (95% CI) 12 cancers responsible for ⅔ US cancer deathsa 73.7% (65.6-80.4%) 6 aggressive cancers with low 5-year survivalb 71.7% (59.2-81.5%) All cancers except breast and prostate cancers 56.4% (49.
Slide 21: MCED Testing Increased Number of Screen-Detected Cancers Over 7 Times
MCED Testing Increased the Number of Screen- Detected Cancers Over 7 Times When Added to Recommended Screeninga 329 participants diagnosed with cancer during 12 months of follow-up 129 (39%) 200 (61%) Clinically detected Screen-detected cancersb cancers MCED, m ulti-cancer early detection; USPSTF, U
Slide 22: MCED Testing Increased Number of Screen-Detected Cancers Over 7 Times
MCED Testing Increased the Number of Screen- Detected Cancers Over 7 Times When Added to Recommended Screeninga 329 participants diagnosed with cancer during Screen-detected breast, cervical, 12 months of follow-up 20 colorectal, or lung cancersa >7x 20 133 MCED-detectedc 129 (39%) 200 (61%) Screen-
Slide 23: Majority of MCED-Detected Cancers Do Not Have Recommended Screening
Majority of MCED-Detected Cancersa Do Not Have Recommended Screeningb Solid Cancers Hematological Cancers N=107 N=26 133 participants with cancers diagnosed across a broad range of cancer types 114 new primary cancers, 18 recurrent cancers, 1 unknown primary site 73% Cancers with recommended of all
Slide 24: Most MCED-Detected New Cancers Were Detected at Early Stages
Most MCED-Detected New Cancersa,b Were Detected at Early Stages 74% of stage I-II cancers Stage I (n=38) 33.3% do not have recommended Stage I-II: screeningd 53.5% Stage II (n=23) 20.2% • Head & Neck (n=14) Stage I-III: • Liver (n=10) 69.3% Colon/Rectum (n=8) 15.8% • Stage III (n=18) • Lymphoid line
Slide 25: Accurate CSO Predictions Guided Rapid Diagnosis
Accurate CSO Predictions Guided Rapid Diagnosis Following a Positive MCED Test Result Median (IQR) Days to Diagnostic Resolution All MCED Positive Participantsa 46 Days 91.7% (42-59) (95% CI: 85.8-95.3%) True Positives 36 Days First CSO Prediction (24-61) Accuracy in True Positives False Positives 7
Slide 26: The MCED Test Was Safe in the Intended Use Population
The MCED Test Was Safe When Implemented in the Intended Use Population Of 25,114 safety analyzable participants who received the MCED test *As of December 31, 2024 0.6% had an invasive procedure to evaluate a positive MCED result At the time of the initial analysis, no serious, study-related adverse
Slide 27: Initial PATHFINDER 2 Results Demonstrated Robust Performance and Safety
Initial PATHFINDER 2 Results Demonstrated Robust Performance and Safety Across a Broad Population 1 In the largest interventional MCED study conducted in the US to date, MCED test Demonstrated robust Increased the number of performance, with a ~62% Enabled prompt, efficient cancers detected by PPV —
Slide 28: NHS-Galleri Study
NHS-Galleri Study Professor Peter Sasieni Director, Cancer Research UK Cancer Prevention Trials Unit Queen Mary University of London 28
Slide 29: Disclosures
Disclosures GRAIL, Inc.: Scientific advisor, grant/research support for NHS-Galleri trial 29
Slide 30: Pivotal Clinical Studies
Pivotal Clinical Studies CCGA • Ability to detect and locate multiple types of cancer • Positive result very rare in people without cancer SYMPLIFY • High positive predictive value in symptomatic patients Clinical validity • Positive result very rare in people without cancer PATHFINDER 2 • Detects c
Slide 31: NHS-Galleri Trial: Prospective, Randomized, Double Blind, Controlled Trial
NHS-Galleri Trial: A Prospective, Randomized, Double Blind, Controlled Trial In England Cancer Signal Participant referred to NHS for diagnostic Cancerc Detected investigations N≈70,000 INTERVENTION No cancer Sample shipped to Galleri test GRAIL, Inc. (US) performed No Cancer Signal 1:1 Detectedb R
Slide 32: NHS-Galleri Trial Timeline
NHS-Galleri Trial Timeline Aug July July July July July July 2026 2021 2022 2023 2024 2025 2027 2030 First trial Last trial appointment appointment Recruitment Annual blood sample collections 1 year after last Follow-up for primary analysis trial appointment 3 years after last Follow-up for mortalit
Slide 33: Surrogate Endpoints Should Be Based on Causal Reasoning
Surrogate Endpoints Should Be Based on Causal Reasoning HPV vaccination Cancer screening Necessary sequence: • Cancers progress through stages. • HPV infection • For most cancers, prognosis gets substantially • Cervical neoplasia worse for more advanced stages. • Invasive cervical cancer • By findin
Slide 34: Meta-analysis: Mortality Reduction vs Advanced Stage Reduction
Meta-analysis: Mortality Reduction vs Advanced Stage Reduction Sasieni, Swanton, Neal. Ann Oncol 2025; 36:706-708 Rebolj et al. Ca Epi Biomarkers Prev 2025; 34:1694-1709 34
Slide 35: NHS-Galleri Trial Primary Objective
NHS-Galleri Trial Primary Objective Incidence of Stage III And IV Cancers1 • Reduction in late stage cancer makes causal sense. • Measuring a reduction in mortality requires much larger and longer studies than than measuring a reduction in late-stage incidence.2 • Early read-out allows earlier, evid
Slide 36: Sequential Conditional Testing Of Primary Objective
Sequential Conditional Testing Of Primary Objective 1 Test for reduction in stage III and IV cancers at 12 pre-specified sitesa If p<0.05 primary endpoint is met • By conditioning on a significant result, there is no need to adjust for 2 Test for reduction in stage III and IV cancers in all routinel
Slide 37: Key Secondary Objectives
Key Secondary Objectives Demonstrate a significant reduction in the absolute numbersa of stage IV cancers diagnosed in the intervention arm compared with the control arm Evaluate MCED test performance, such as episode sensitivity, specificity, and positive predictive value Measure overall cancer det
Slide 38: Assessing Cancer-Specific Mortality
Assessing Cancer-Specific Mortality Although the NHS-Galleri Trial is Not Powered for Mortality, Cancer- Specific Mortality Will be Assessed in a Number Of Complementary Ways 5 years after last trial appointment Predicted mortality Nested 3 years after last mortality trial appointment Observed morta
Slide 39: Q&A
Q&A Advancing towards our vision of population-scale multi-cancer early detection CONF IDE NTI AL & P RO PR I ETAR Y 39
Slide 40: Brief intermission
GRA:L Brief intermission
Slide 41: International Opportunity
International Opportunity Sir Harpal Kumar Chief Scientific Officer & President, International 41
Slide 42: The Global Addressable Market is Significant
The Global Addressable Market is Significant #2 Cause of death globally, 10M annually1,2 >100M US screening population 19M Annual new cases globally >300M $25T Estimated global economic cost of Total addressable in US, EU, UK and Japan cancer care 2020-20503 1WHO, All Cancers Fac t Sheet 2020. 2 ACS
Slide 43: Opportunistic Expansion Globally Through Partnerships
Opportunistic Expansion Globally Through Partnerships Near Term International Expansion Path • Partner-led expansion to new international markets • Expanding patient access in resource- and capital-efficient model to unlock latent private market demand • Announced partnerships in Canada, Israel, and
Slide 44: Samsung & GRAIL Strategic Collaboration
Samsung & GRAIL Strategic Collaboration • GRAIL and Samsung C&T will work as exclusive partners to commercialize the Galleri test in South Korea, with a possible extension into other Asian geographies, including Japan and Singapore* • Samsung C&T will undertake key activities to drive adoption of Ga
Slide 45: Commercial Update
Commercial Update Andy Partridge Chief Commercial Officer 45
Slide 46: Leader in an Expansive Global Market
Leader in an Expansive Global Market Galleri® leadership across awareness, performance, Defining the and access multi-cancer early ● Patient awareness is spreading: thousands have received a Galleri ‘Cancer detection (MCED) Signal Detected’ result category ● Breadth of detection: >50 cancer types, m
Slide 47: Strong adoption trends underway
Strong adoption trends underway Volume growth, provider expansion, and broad national utilization 26% 16k+ 29% Galleri Q3 volume Lifetime ordering Q325 volume from growth (YoY) providers through Q325 repeat annual tests 37% 20% 18 months Galleri Q3 growth from Increase in depth of ordering Median ti
Slide 48: Collaborations support efficiency, scale, and flexibility
Collaborations support efficiency, scale, and flexibility ● Quest Diagnostics simplifies ordering, broadens phlebotomy access, and enables bulk, kitless shipping ● athenahealth EHR integration automates ordering and results delivery ● Recuro Health enables telehealth ordering through Galleri.com and
Slide 49: GRAIL has established MCED leadership within digital health
GRAIL has established MCED leadership within digital health ✓ Access to curated health-focused, cash-pay member bases ✓ Strong consumer marketing and patient acquisition ✓ Scalable partnerships accelerate prescriber adoption and care integration ✓ Digital health success drives health-system engageme
Slide 50: Synergies with Employers, Health Systems and payers
Synergies with Employers, Health Systems and payers are driving market development and growth ● 150+ self-insured employers across 15+ industries ● Deepest adoption in manufacturing, labor & trust, tech, energy, and financial services ● Payer offering Galleri as an opt-in benefit to self-insured “Ca
Slide 51: Health System Partnerships will pave the road for care workflows
Health System Partnerships will pave the road for care workflows and broad adoption Clinical Validation System Integration & Adoption Market Influence Positive performance data Driving workflow adoption and market Growing payer from Mayo Clinic and influence engagement as benefit Dana-Farber publica
Slide 52: Panel Presentation
Panel Presentation Anil Saldanha Dr. Andrea Klemes Chief Innovation Officer, Chief Medical Officer Rush University System at MDVIP for Health Dr. James Friedman Dr. Eric Sue Founder of Adult Partner at the Internal Medicine of Sue Medical Group North Scottsdale CONFIDENTIAL & PROPRIETARY
Slide 53: Q&A
Q&A Advancing towards our vision of population-scale multi-cancer early detection CONFIDENTI AL & PROPRIETARY 53
Slide 54: Detect cancer early, when it can be cured.
Detect cancer early, when it can be cured. 54