Grail, Inc. · NASDAQ:GRAL

Grail — European Society for Medical Oncology (ESMO) Congress 2025

18 slides from Grail's conference presentation, Oct 16, 2025

  1. Slide 1: Safety and Performance of a Multi-Cancer Early Detection Test: Initial PATHFINDER 2 Results

    Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended Use Population: Initial Results from the Registrational PATHFINDER 2 Study ABSTRACT #LBA64 Nima Nabavizadeh; Charles McDonnell; Dax Kurbegov; Marc Matrana; Shirish Gadgeel; Raymond H. Kim; Gretchen Stipec; Kevin Oeff

  2. Slide 2: Declaration of Interests

    DECLARATION OF INTERESTS Nima Nabavizadeh, MD Cancer Early Detection Advanced Research Center Knight Cancer Institute, Oregon Health & Science University Portland, OR Presenting author declarations: ● GRAIL: Advisory Board ● MJH Life Sciences: Writing Engagement ● Quattro Consulting: Market Research

  3. Slide 3: GRAIL's MCED Blood-Based Targeted Methylation Test

    GRAIL’s MCED Blood-Based Targeted Methylation Test The MCED test (Galleri®, GRAIL, Inc.) detects cancer signals from cell-free DNA (cfDNA) in blood and predicts cancer signal origin (CSO) to guide diagnostic evaluation Positive (Cancer signal detected) Machine learning classifier Predicted CSOb (eg,

  4. Slide 4: GRAIL Clinical Development Program

    GRAIL Clinical Development Program Test Development, Validation, and Implementation in Population-Scale Studies CCGA Develop and validate a cell-free DNA-based MCED test Annals of Oncology and Cancer Cell 1 (n=15,254) Enrollment: complete, published 2020-20231-3 PATHFINDER Evaluate clinical implemen

  5. Slide 5: PATHFINDER 2: The Largest Interventional MCED Study Conducted in the US to Date

    a PATHFINDER 2 : The 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-upb Participant informed of MCED test Negative result (No cancer signal

  6. Slide 6: Enrolled a Diverse Participant Population That Reflects Intended Use Population

    Enrolled a Diverse Participant Population That Reflects Intended Use Population Baseline Demographics and Characteristicsd Median Age (IQR), years 65 (59-71) Consented (With ≥12 Months of Age Groups Follow-Up) Data cutoff December 31, 2024 50-59 years 27.0% N=25,578 60-69 years 44.4% a ● Data not cl

  7. Slide 7: Observed PPV Was ~62% Across All Cancers

    Observed PPV Was ~62% Across All Cancers Cancer Status Over 12 Months of Follow-up (Performance Analyzable Cohort) Cancer No Cancer Performance Diagnosis Diagnosis Total Metric (95% CI) (n=329) (n=22,832) (N=23,161) PPV Positive 133 83 216 61.6% Cancer Signal MCED Detection Rate = Test (54.9-67.8%)

  8. Slide 8: Observed PPV Was ~62% Across All Cancers

    Observed PPV Was ~62% Across All Cancers Cancer Status Over 12 Months of Follow-up (Performance Analyzable Cohort) Cancer No Cancer Performance Diagnosis Diagnosis Total ● MCED test PPV ranged Metric (95% CI) (n=329) (n=22,832) (N=23,161) from 42.9%-49.4% in PPV prior clinical studies and Positive 1

  9. Slide 9: Demonstrated 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 73.7% (65.6-80.4%) deathsa 6 aggressive cancers with low 5-year 71.7% (59.2-81.5%) survivalb All cancers except breast and prostate 56.4% (49.4-63.2%)

  10. Slide 10: MCED Testing Increased Screen-Detected Cancers Over 7x When Added to Recommended Screening

    MCED Testing Increased the Number of Screen-Detected a Cancers Over 7x When Added to Recommended Screening 329 participants diagnosed with cancer during 12 months of follow-up 129 (39%) 200 (61%) Clinically-detected Screen-detected cancersb cancers MCED, multi-cancer early detection; USPSTF, United

  11. Slide 11: MCED Testing Increased Screen-Detected Cancers Over 7x When Added to Recommended Screening

    MCED Testing Increased the Number of Screen-Detected a Cancers Over 7x When Added to Recommended Screening 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-detec

  12. Slide 12: MCED Testing Increased Screen-Detected Cancers Over 7x When Added to Recommended Screening

    MCED Testing Increased the Number of Screen-Detected a Cancers Over 7x When Added to Recommended Screening 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-detec

  13. Slide 13: Majority of MCED-Detected Cancers Do Not Have Recommended Screening

    a Majority of MCED-Detected Cancers Do Not Have b Recommended Screening Solid Cancers Hematological Cancers ● 133 participants with N=107 N=26 cancers diagnosed across a broad range of cancer types ○ 114 new primary cancers, 18 recurrent cancers, 1 unknown primary site ● 73% of all MCED-detected Can

  14. Slide 14: Most MCED-Detected New Cancers Were Detected at Early Stages

    a,b Most MCED-Detected New Cancers Were Detected at Early Stages 74% of stage I-II cancers do Stage I (n=38) 33.3% Stage I-II: not have recommended 53.5% screeningd Stage II (n=23) 20.2% Stage I-III: ● Head & Neck (n=14) ● Liver (n=10) Stage III (n=18) 15.8% 69.3% ● Colon/Rectum (n=8) ● Lymphoid lin

  15. Slide 15: Accurate CSO Predictions Guided Rapid Diagnosis Following a Positive MCED Test Result

    Accurate CSO Predictions Guided Rapid Diagnosis Following a Positive MCED Test Result Median (IQR) Days to Diagnostic Resolution All MCED Positive Participantsa 46 (42-59) days 91.7% (95% CI: 85.8-95.3%) True Positive 36 (24-61) days first CSO prediction accuracy in true positives False Positive 75

  16. Slide 16: The MCED Test Was Safe When Implemented 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 (data cutoff 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

  17. Slide 17: Invasive Procedures Were ~2x More Common for True Positives Than False Positives

    Invasive Procedures Were ~2x More Common for True Positives Compared to False Positives 70.6% (89/126) Percentage of Participants Receiving Lab Test 70.1% (54/77) Targeted Diagnostic Evaluationa Non-Invasive Imaging Test 84.1% (106/126) Evaluations 85.7% (66/77) 27.0% (34/126) Non-Invasive 31.2% (24

  18. Slide 18: Initial PATHFINDER 2 Results Demonstrated Robust Performance and Safety Across a Broad Population

    Initial PATHFINDER 2 Results Demonstrated Robust Performance and Safety Across a Broad Population In the largest interventional MCED study conducted in the US to date, the MCED test: Increased the number Demonstrated robust Enabled prompt, of cancers detected by performance, with a ~62% efficient di

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