Grail, Inc. · NASDAQ:GRAL
Grail — Technical Presentation (April 2024)
16 slides from Grail's technical presentation, April 2024
Slide 1: Early Real-World Experience With Repeat Multi-Cancer Early Detection (MCED) Testing
Early Real-World Experience With Repeat Multi-Cancer Early Detection (MCED) Testing Ora Gordon, MD, MS Providence Saint Joseph Health, Los Angeles, CA; Saint John’s Cancer Institute, Santa Monica, CA Richard Abrams,1 Rita Shaknovich,2 Jordan Lipton,3 Matthew McMillin,4 Adam Schneider,5 Matt Margolis
Slide 2: Disclosure Information
Disclosure Information Dr. Ora Gordon ▪ Institutional research support from Grail ▪ Scientific Advisor Grail (within 24 months but not currently) ▪ Scientific Advisor, Genetic Technologies Corp
Slide 3: Multi-Cancer Early Detection With Galleri Test
Multi-Cancer Early Detection With Galleri® Test No cancer signal detected Cancer signal detected Tumor sheds Blood plasma Targeted Machine cfDNA Isolated methylation learning Cancer signal origin fragments into (contains analysis of cfDNAa classifier bloodstream cfDNA (sequencing, predicted fragment
Slide 4: Real World Evidence Cohorts
Real World Evidence Cohorts Repeat-test Cohort First-test Cohort 5,794 individuals 47,016 individuals ≥2 valid test results by 4Aug23 First valid test result by 31Dec22 First valid test result was Excludes individuals with repeat tests “No Cancer Signal Detected” Clinical outcomes collected as part
Slide 5: Repeat Testing Spanned The United States
Repeat Testing Spanned The United States 5794 total people had repeat testing as of Aug 2023
Slide 6: Most MCED Test Patients Are 50–70 Years Old
Most MCED Test Patients Are 50–70 Years Old Age distribution was similar between repeat- and first-test cohorts, but significantly higher % of repeat test participants were ≥50 35 Repeat Test Age Repeat Test First Test n = 5,794 30 First Test <50 871 (15%) 9,877 (21%) 25 n = 47,016 ≥50 4,923 (85%) 3
Slide 7: Most Repeat Tests Were Taken Within Months Of Annual Cadence
Most Repeat Test Were Taken Within 2 Months Of Annual Cadence n = 5,794 Months Between Tests 81% within 10–18 months 56% within 10–14 months No cancer signal detected (n=5,768) Cancer signal detected (n=26) Cancer diagnosed (n=12) Date of First Test
Slide 8: Cancer Signal Detection Rate Is 0.45% In Repeat Test Cohort
Cancer Signal Detection Rate Is 0.45% In Repeat Test Cohort Repeat Tests First Tests n = 5,794 n = 47,016 No Cancer Signal Cancer Signal Cancer Signal n = 5,768 n = 26 n = 519 Signal Detection Rate = 0.45% Signal Detection Rate = 1.1% 95% CI: 0.31–0.66% 95% CI: 1.0–1.2%
Slide 9: Over 70% of CSOs With Repeat Testing Contain Cancers Without Current Screening Options
Over 70% of CSOs With Repeat Testing Contain Cancers Without Current Screening Options Cancer Signal Origin (n = 26) Stomach/Esophagus Bone and Soft Tissue Lymphoid Lineage n=7 Prostate Plasma Cell Lineage Most common Pancreas/Gallbladder repeat-test CSOs n=1 Ovary • Lymphoid lineage Lung • Head and
Slide 10: Repeat Testing Reveals Potential Shift Towards Cancers Without Recommended Screening
Repeat Testing Reveals Potential Shift Towards Cancers Without Recommended Screening 30% 25% Repeat Test First Test Repeat testing trends n = 26 n = 519 Lymphoid lineage, head and neck, colon/rectum Percentage of CSOs 20% remain among top CSOs 15% Bladder/urothelial CSO percentage increased 10% 5% 0
Slide 11: More Than 50% Of Patients With Known Clinical Outcomes Were Diagnosed With Cancer
More Than 50% Of Patients With Known Clinical Outcomes Were Diagnosed With Cancer Repeat Tests n = 5,794 Cancer Signal Detected n = 26 Clinical Outcomes Still Under Investigation n = 21 n=5 Cancer Diagnosed No Cancer Diagnosed n = 12 n=9
Slide 12: Cancers Diagnosed After Repeat Testing Were Mostly Early Stage And Without Screening Options
Cancers Diagnosed After Repeat Testing Were Mostly Early Stage And Without Screening Options Lymphoma* (Stage 0, I, Unknown) Head and Neck (Stage I) Lymphoid Leukemia* (Unknown) Lung (Unknown) CSO accuracy was 100% in the 12 diagnosed cancers Colon/Rectum (Unknown) Bladder (Stage I, Unknown) Anus (S
Slide 13: High Percentage Of Stage I Diagnoses With Repeat Testing
High Percentage Of Stage I Diagnoses With Repeat Testing Percentage of Diagnosed Cancers 60% Repeat Test First Test 50% n = 12 n = 120 40% 30% 20% 10% 1 4 9 7 16 1 25 5 6 58 0% Stage 0 Stage I Stage II Stage III Stage IV NA Unknown N values shown at bottom of each column. NA, not applicable or no AJ
Slide 14: Strengths And Limitations
Strengths And Limitations The strength of real-world evidence is that it provides insight into how a test is being used in a clinical practice setting and improves generalizability of data Limitations include limited data availability and timing of reporting between practices The population who have
Slide 15: Conclusions
Conclusions Cancer Signal Origin accuracy was 100% CSO is a unique feature of this MCED test and helps direct diagnostic work up Among the 6 confirmed cancers with known stage, 5/6 were stage 0 or 1 1 was stage 0: chronic lymphocytic leukemia 4 were stage I: head and neck, anus, lymphoma, blad
Slide 16: Acknowledgements
We gratefully acknowledge the contributions to this effort of the patients, staff, and healthcare providers who provided clinical data