Galleri trial data and new CEO package at GRAIL (NASDAQ: GRAL) spotlight MCED progress
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
GRAIL, Inc. updated the employment terms for its new Chief Executive Officer, Dr. Joshua Ofman, and showcased detailed clinical data for its Galleri multi‑cancer early detection test. The amended offer letter makes Dr. Ofman the principal executive officer as of June 1, 2026, with an annual base salary of $800,000 and a variable compensation plan target equal to 100% of salary from that date. He will receive restricted stock units valued at $2,000,000, vesting over four years, and significant severance protections, including up to 24 months of salary, 200% of target bonus, full equity acceleration, and extended healthcare benefits if he is terminated without cause or resigns for good reason in connection with a change in control.
The accompanying investor presentation from ASCO 2026 highlights results from the NHS‑Galleri and PATHFINDER 2 trials, covering roughly 180,000 participants. Adding Galleri to standard screening reduced Stage IV cancers for 12 deadly cancer types by more than 20% in incident screening rounds, increased early‑stage (Stage I/II) detections by about 16%, and quadrupled screening‑detected cancers versus standard screening alone. The test showed positive predictive value around 52–60%, a false positive rate below 0.5%, and high accuracy in predicting cancer signal origin, with no serious study‑related adverse events reported.
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Negative
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Insights
GRAIL pairs strengthened CEO package with encouraging MCED trial data.
GRAIL elevates Dr. Joshua Ofman to Chief Executive Officer with a compensation structure typical for late‑stage biotech leaders: a $800,000 base salary, 100% bonus target, $2,000,000 in RSUs, and robust change‑in‑control protections. This suggests a commitment to long‑term leadership stability as Galleri advances.
Clinically, NHS‑Galleri and PATHFINDER 2 together cover about 180,000 participants and show multi‑cancer early detection performance consistent across settings. The NHS‑Galleri trial reports more than a 20% reduction in Stage IV cancers in incident screening rounds and about 16% more Stage I/II cases, while maintaining a false positive rate under 0.5% and positive predictive value near 52–60%.
These results indicate the test can find more cancers earlier, with manageable downstream diagnostics and no serious study‑related adverse events. Future company disclosures will be important for linking these clinical outcomes to reimbursement, guideline adoption, and commercial uptake, especially as longer‑term follow‑up from NHS‑Galleri and PATHFINDER 2 matures.
8-K Event Classification
3 items: 5.02, 8.01, 9.01
3 items
Item 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers
Governance
Key personnel changes including departures, elections, or appointments of directors and executive officers.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
CEO base salary: $800,000 per year
RSU grant value: $2,000,000
Change-in-control severance salary multiple: 24 months
+5 more
8 metrics
CEO base salary
$800,000 per year
Annual base salary for Dr. Ofman from June 1, 2026
RSU grant value
$2,000,000
Restricted stock units vesting over four years from May 31, 2026
Change-in-control severance salary multiple
24 months
Cash severance equal to 24 months of then-current base salary
Change-in-control bonus multiple
200% of target bonus
Lump-sum payment based on then-current annual target bonus
NHS-Galleri participants
142,826 participants
Randomized multi-cancer early detection trial population
Stage IV reduction
>20% reduction
Decrease in Stage IV cancers in incident rounds for 12 deadly cancers
Increase in early-stage cancers
16% increase
More Stage I/II cancers detected in intervention arm
Galleri false positive rate
0.45%
Study-related false positive rate in NHS-Galleri intervention arm
Key Terms
Change in Control, Good Reason, multi-cancer early detection, PPV, +2 more
6 terms
Change in Control financial
"during the period commencing 3 months prior to, and ending 24 months following the consummation of a Change in Control"
A "change in control" occurs when the ownership or management of a company shifts significantly, such as through a merger, acquisition, or sale of a large part of its assets. This change can impact how the company is run and may influence its future direction. For investors, it matters because it can affect the company's stability, strategy, and value, often signaling potential changes in investment risk or opportunity.
Good Reason financial
"or Dr. Ofman resigns for Good Reason (as defined in the Amended Offer Letter)"
multi-cancer early detection medical
"First randomized controlled study of an MCED test"
A multi-cancer early detection test is a medical screening tool—often a simple blood test—that looks for biological signals, such as abnormal DNA or protein patterns, that could indicate many different cancers before symptoms appear. For investors it matters because successful tests can reshape demand for diagnostics, influence healthcare spending and insurance coverage, and create new revenue streams or risks for companies across diagnostics, treatment and screening services; think of it as a smoke alarm that can warn of problems throughout an entire house rather than just one room.
PPV financial
"52% PPV | 0.45% False Positive Rate"
PPV (positive predictive value) is the share of positive test results that actually indicate the condition is present — in other words, how often a ‘positive’ is truly positive. For investors, PPV shows how reliable a diagnostic or screening product is in real-world use, affecting clinical adoption, regulatory and reimbursement prospects, and commercial value; think of it like a fire alarm’s accuracy at signaling a real fire versus a false alarm.
Episode sensitivity medical
"Episode sensitivity 31% All; 55% 12D CSO Accuracy 92.5%"
COBRA regulatory
"healthcare coverage for Dr. Ofman and his dependents pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”)"
COBRA is a U.S. federal law that lets employees and their dependents temporarily keep employer-sponsored health insurance after job loss, reduction in hours, or other qualifying events by paying the premiums themselves. Investors should care because offering COBRA can affect a company’s cash flow, administrative costs and legal disclosures when workforce changes occur—similar to a former club member paying to keep their membership active after leaving the club.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________________________________
FORM 8-K
_____________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 1, 2026
_____________________________________________
(Exact Name of Registrant as Specified in Charter)
___________________________________________
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (833 ) 694-2553
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
___________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 5.02 | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers | ||||
In connection with Dr. Joshua Ofman’s appointment as the Chief Executive Officer of GRAIL, Inc. (the “Company”), on June 1, 2026, the Company’s board of directors (the “Board”) approved an amended and restated offer letter (the “Amended Offer Letter”) and authorized and directed the Company to enter into such Amended Offer Letter with Dr. Ofman, with the Amended Offer Letter effective as of June 1, 2026 (the “Effective Date”). The Amended Offer Letter supersedes and replaces Dr. Ofman’s existing offer letter. Pursuant to the Amended Offer Letter, Dr. Ofman will serve as the Company’s principal executive officer commencing on the Effective Date.
The Amended Offer Letter provides that Dr. Ofman will receive an annual base salary initially set at $800,000 and will continue to be eligible to participate in the Company’s Variable Compensation Plan (the “VCP”), with a target, from and after the Effective Date, equal to 100% of his annual base salary (his prior VCP target of 60% will continue to apply for the portion of calendar year 2026 preceding the Effective Date). Dr. Ofman will also continue to be eligible to participate in the Company’s health and welfare benefit programs generally available to its senior executives. As soon as reasonably practicable following the Effective Date, the Company will grant Dr. Ofman an award of restricted stock units (“RSUs”) with an aggregate grant date value of $2,000,000, vesting in equal annual installments on each of the first four anniversaries of May 31, 2026, subject to his continued employment through the applicable vesting date.
The Amended Offer Letter provides that if, during the period commencing 3 months prior to, and ending 24 months following the consummation of a Change in Control (as defined in the Company’s 2024 Incentive Award Plan) (the “CIC Period”), the Company terminates Dr. Ofman’s employment without Cause (as defined in the Amended Offer Letter) (other than as a result of his death or disability) or Dr. Ofman resigns for Good Reason (as defined in the Amended Offer Letter), then, subject to his execution of an effective release of claims and continued compliance with applicable restrictive covenants, in addition to accrued amounts (including any continuing rights to indemnification, rights to advancements and directors’ and officers’ liability insurance) (the “accrued obligations”), the Company will provide Dr. Ofman with the following severance benefits:
•a lump-sum cash payment equal to 24 months of his then-current base salary;
•a lump-sum cash payment in an amount equal to 200% of his then-current annual target bonus;
•acceleration in full of the vesting of any outstanding equity or equity-linked awards (with performance awards vesting at target); and
•continued Company-paid healthcare coverage for Dr. Ofman and his dependents pursuant to the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”) for up to 24 months.
The Amended Offer Letter further provides that upon any of the employment terminations described above occurring other than during the CIC Period, subject to Dr. Ofman’s execution of an effective release of claims and continued compliance with applicable restrictive covenants, in addition to the accrued obligations, the Company will provide Dr. Ofman with the following severance benefits:
•a lump-sum cash payment equal to 12 months of his then-current base salary;
•a lump-sum cash payment in an amount equal to 100% of his then-current annual target bonus;
•continued Company-paid healthcare coverage for Dr. Ofman and his dependents under COBRA for up to 12 months; and
•12 months of additional vesting for any outstanding equity or equity-linked awards.
The Amended Offer Letter also provides that the Company will reimburse Dr. Ofman for his reasonable attorney’s fees and costs incurred in connection with the negotiation of the Amended Offer Letter, up to a maximum of $25,000.
The foregoing summary of the Amended Offer Letter does not purport to be complete and is subject to, and qualified in its entirety by, reference to the Amended Offer Letter, which is filed as Exhibit 10.1 hereto.
Item 8.01 | Other Events. | ||||
On May 31, 2026, the Company posted a slide presentation in the “Investor Relations” portion of its website at www.grail.com. A copy of the presentation is filed as Exhibit 99.1 hereto and is incorporated herein by reference. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
Item 9.01 | Exhibits. | ||||
(d) Exhibits
| Exhibit No. | Description | |||||||
10.1 | Amended Offer Letter by and between the Company and Joshua Ofman | |||||||
99.1 | Company Presentation dated May 31, 2026 | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GRAIL, INC. | ||||||||||||||
| Date: | June 1, 2026 | By: | /s/ Abram Barth | |||||||||||
| Name: | Abram Barth | |||||||||||||
| Title: | Chief Legal Officer | |||||||||||||
GRAIL Analyst Call American Society of Clinical Oncology May 31, 2026 1
CONFIDENTIAL & PROPRIETARY 2 Legal Disclosures 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,” the negative of these terms, and other comparable terminology. These forward-looking statements, which are subject to risks, uncertainties, and assumptions about us, may include expectations of our clinical studies, future tests or products, technology, regulatory compliance, potential market opportunity, anticipated growth strategies, applicability of results to a broad population, and interpretations of these results by regulators or payers, among others. These statements are only predictions based on our current expectations and projections about future events and trends. There are important factors that could cause our actual results, level of activity, performance, or achievements to differ materially and adversely from those expressed or implied by the forward-looking statements, including those factors and numerous associated risks discussed under the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q for the periods ended March 31, 2026 (the “Form 10-Q”). Moreover, we operate in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results, level of activity, performance, or achievements to differ materially and adversely from those contained in any forward-looking statements we may make. Forward-looking statements relate to the future and, accordingly, are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Although we believe the expectations and projections expressed or implied by the forward-looking statements are reasonable, we cannot guarantee future results, level of activity, performance, or achievements. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, we undertake no obligation to update any of these forward-looking statements after the date of this presentation to conform our prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
3 GRAIL at ASCO 2026 NHS-Galleri Trial PATHFINDER 2 First randomized controlled study of an MCED test Evaluated annual screening with the Galleri test in addition to standard of care screening over three years in more than 142,000 participants Largest interventional MCED study in North America Evaluated performance of a single MCED test in an asymptomatic population of ~35,000 individuals aged 50+
NHS-Galleri 4
CONTROL GROUP Standard of care Three annual screening rounds with additional follow-up to assess long-term impact on cancer outcomes 5 NHS-Galleri: The First and Only Randomised Controlled Clinical Utility Trial of an MCED Test Study Population 142,826 consented participants INTERVENTION GROUP Standard of care + Galleri Randomized 1:1 CANCER SIGNAL DETECTED Results reported to participant NO CANCER SIGNAL DETECTED Screening rounds & follow-up Round 1 (year 0) Round 2 (year 1) Round 3 (year 2) Post 1-year follow-up Blood draw Prevalent round Blood draw Blood draw Additional follow-up (ongoing) Additional follow-up (planned) Current (year 3) Future (years 4+)1 year 1 year 1 year 71,122 participants 71,128 participants MCED test performed Referred to diagnostic pathway CANCER DIAGNOSED NO CANCER DIAGNOSED Return for 1- & 2-year follow-up visits Participants (with or without a cancer signal) return for follow-up visits, and outcomes are captured through NHS pathways and national registry
Endpoint Finding Primary | Reduction in combined Stage III and Stage IV cancers 12 deadly cancers Combined reduction not significant Secondary | Reduction in Stage IV cancers 12 deadly cancers >20% reduction in incident rounds Secondary | Increase in Stage I and Stage II cancers 12 deadly cancers ~16% more Stage I/II cancers detected Secondary | MCED Test Performance & Safety All intervention arm participants 52% PPV | 0.45% False Positive Rate Episode sensitivity 31% All; 55% 12D CSO Accuracy 92.5% No Serious Related Adverse Events Exploratory | Increase in total cancers detected vs. SOC All detected cancers 4x as many cancers detected when added to SOC vs. SOC alone Exploratory | Reduction in Clinical & Emergency Presentation All detected cancers 21% reduction in clinical presentation 25% reduction in emergency presentation The NHS-Galleri Trial Assessed Multiple Endpoints 6
-20% -10% 0% 10% 20% 30% All 3 rounds First round Second round Third round + follow up Stage III Stage IV 7 Primary Endpoint: Here is What We Observed Denominator is control arm; measured on the 12 pre-specified types were lung, head & neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder. Change in stage III/IV cancers diagnosed (intervention v control)—12 pre-specified cancers Prevalent Incident Rounds Incidence Rate Ratio (Intervention/Control) 1.03 (0.92, 1.14) p=0.6234 1.19 (0.98, 1.43) 0.95 (0.77, 1.17) 0.88 (0.73, 1.07) Pe rc en t D iff er en ce ↑ 3% ↑ 19% ↓ 5% ↓ 12% Relative incidence of stage III/IV cancers decreased after the first screening round Increase in Stage III cancers impacted primary endpoint ↓ 14% ↑ 25%
The Intervention Arm Showed A Clinically Meaningful Stage IV Reduction: ≥22.0% Reduction in Incident Rounds Denominator is control arm; measured on the 12 pre-specified types were lung, head & neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder. -30% -20% -10% 0% All 3 rounds First round Second round Third round + follow up ↓ 26% ↓ 22% ↓ 9% ↓ 14% Change in Stage IV Cancers Diagnosed (Intervention v. Control) - 12 Pre-Specified Cancers Prevalent Incident Rounds Incidence Rate Ratio (Intervention/Control) 0.86 (0.744, 0.998) 0.91 (0.71, 1.18) 0.78 (0.57, 1.06) 0.74 (0.57, 0.95) 8 Pe rc en t D iff er en ce
9 Detecting Cancers Prior to Stage IV Has Real Benefits For Many Cancers 12 prespecified cancer types were lung, head & neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder. Anus and myeloma/plasma cell neoplasms were excluded from the graph due to having only 0 to 1 stage IV cancers in each arm. aFor patients diagnosed in England 2016-2020 (all ages) by stage at diagnosis. 1Cancer Survival in England, cancers diagnosed 2018 to 2022, followed up to 2023. 2026. Accessed May 19, 2026. https://digital.nhs.uk/data-and-information/publications/statistical/cancer-survival-in-england/. Bladder Liver/bile duct Oesophagus Head & neck Colorectum Lung Stomach Lymphoma Ovary Pancreas England 5-year net survival estimatesa,1 Stage IV 5.8% 2.6% 6.2% 38.4% 11.0% 4.5% 4.5% 65.7% 16.2% 2.1% Stage III 31.8% 13.5% 24.7% 54.5% 64.2% 16.7% 24.6% 72.6% 32.4% 8.7% Difference +26.0% +10.9% +18.5% +16.1% +53.2% +12.2% +20.1% +6.9% +16.2% +6.6%
163 157 57 50 36 23 22 13 11 9 9 9 210 151 49 48 47 28 30 25 24 11 6 18 0 50 100 150 200 Colorectal Lung Head & neck Bladder Lymphoma Pancreas Liver/bile duct Oesophagus Myeloma/ plasma cell neoplasm Stom ach Anus Ovary Control Intervention 10 16% More Stage I-II Cancers Were Identified in the Intervention Arm MCED, multi-cancer early detection; SOC, standard-of-care a12 Prespecified Cancer types were lung, head & neck, colorectal, pancreas, myeloma/plasma cell neoplasm, liver/bile duct, stomach, esophagus, anus, lymphoma, ovary, and bladder. bPer highest stage. Charles Swanton, MD, PhD 559 647 559/1298 (43.1%) 647/1421 (45.3%) St ag e I-I I d ia gn os ed c an ce rs ↑ 16% ↑ 28.8% ↑ 30.6% ↑ 21.7% ↑ 36.4% ↑ 92.3% ↑ 118.2% ↑ 22.2% ↑ 100.0% ↓ 3.8% ↓ 14.0% ↓ 4.0% ↓ 33.3%
Cancer Status Cancer diagnosis (n=3,051) No cancer diagnosis (n=194,095) Total (N=197,146) Performance metric (95% CI) MCED Test Result Positive 937 864 1,801 PPVb 52.0% (49.7-54.3%) Negative 2,114 193,231 195,345 NPV 98.92% (98.87-98.96%) Performance metric (95% CI) Episode sensitivityc 30.7% (29.1-32.4%) Specificity 99.55% (99.52-99.58%) MCED, multi-cancer early detection; NPV, negative predictive value; PPV, positive predictive value. Intervention-arm test performance analysable set. a Calculated using all participants within the performance analyzable set, defined as participants who were clinically eligible and evaluable and had evaluable MCED test results; third round follow-up time was 12 months. b PPV for the first (prevalent) screening round only was 58.0% (54.4-61.6%). c12-month episode sensitivity was calculated as the number of participants with a positive MCED test result and a cancer diagnosis within the follow-up period for that round out of all participants with a cancer diagnosed in that round. Robust MCED Test Performance in UK Population Aggregate MCED Test Performance Over 3 Screening Roundsa CSO Accuracy 92.5% (90.7-94.0%) Episode sensitivityc aggregated across rounds 54.7% (51.8-57.5%) First screening round 63.4% (58.9-67.7%) Episode sensitivitya First screening round 37.2% (34.4-40.0%) 12 Prespecified cancer types PPV First screening round 58.0% (54.4-61.6%) 11
12 Trial Demonstrated Low False Positive Rate & No Related Serious Adverse Events 864 false positives (303 in first screening round) 54/303 (17.8%) were subsequently diagnosed with cancer in the second or third screening round Of these, 44/54 (81%) had a correct CSO prediction in the first screening round CSO, cancer signal origin; MCED, multi-cancer early detection. AE, adverse event; MCED, multi-cancer early detection; SOC, standard-of-care. All other adverse events includes participants with AEs other than phlebotomy, such as anxiety, emotional distress, dizziness. Note: a participant may have had more than one adverse event. Number of adverse events 276 325 114 13 0 100 200 300 400 Intervention Control Phlebotomy All others No serious study-related AEs occurred from blood sample collection or return-of-test results 0.45% (321/71,128) and 0.52% (371/71,122) participants in the control and intervention arms, respectively, experienced a study-related AE collected from blood sample collection up to referral into NHS
13 Adding Galleri to Standard of Care Quadrupled the Number of Screening-Detected Cancers MCED, multi-cancer early detection. aBreast, colorectal, cervical, and lung (for high-risk individuals) cancer. bIncludes 10 unstageable cancers (no staging system exists) and 55 cancers with missing stage information. 290 236 202 164 274 232 Control Intervention ↑ 4x Screening- detected Unstageable/missingb Stage IV Stage III Stage II Stage I NHS Screening-detecteda MCED- detected (n=937) More stage I & II cancers were detected by Galleri than by all SOC screening in the control arm (366 v. 290) Finding more cancers through screening enabled: A 21% reduction in clinically-detected cancers (3110 v. 2464) A 25% reduction in cancers diagnosed through emergency presentation (286 v 213) All Screening-Detected Cancers
14 Galleri Detected Many Deadly Cancers at Early Stages MCED, multi-cancer early detection. Total Galleri cancers detected are 937; table excludes cancer types with 10 or fewer detected cancers: Bladder, Anus, Melanoma, CUP, Mesothelioma, Small Intestine, Germ Cell, Vulva, Brain, Penis, Vagina, Multiple Cancers, Sarcoma, Urothelial Tract, Cervix, Thyroid NA indicates missing or unstageable cancers Cancer Type I II III IV NA Total Colon/Rectum 56 45 63 27 2 193 Lung 13 14 60 44 1 132 Prostate 16 8 37 42 2 105 Lymphoma 11 10 20 30 1 72 Breast 10 29 11 9 1 60 Plasma Cell Neoplasm 4 4 0 0 36 44 Esophagus 4 9 17 10 3 43 Pancreas 2 4 6 23 1 36 Head & Neck 22 3 7 3 0 35 Ovary 6 3 17 9 0 35 Liver/Bile Duct 11 12 6 4 1 34 Lymphoid Leukemia 19 3 0 0 4 26 Stomach 1 5 7 6 0 19 Uterus 8 3 3 4 0 18 Gallbladder 0 4 4 7 0 15 Kidney 1 3 5 3 2 14 >20% ~40% ~70% Detected Stage I II III Detected Stage I II III Detected Stage I II III Detected cancers without a NHS screening program ~60%
PATHFINDER-2 15
16 PATHFINDER 2: The Largest Interventional MCED study In North America Primary Objective: Evaluate safety and performance of the MCED test in a large, diverse intended use population 35,878 Participants Age ≥50 Years from 32 North American healthcare systems with 3 years of follow-up CANCER SIGNAL DETECTED Test result communicated Diagnostic follow-up proceduresb (recommend in protocol based on CSO) NO CANCER SIGNAL DETECTED Follow-up and planned analyses 12 months (current data) Blood draw Diagnostic resolution CANCER IDENTIFIED NO CANCER IDENTIFIED Test result communicated Protocol-specified diagnostic PET-CT Research blood draw Current results reflect ~12 months of follow-up 24 months (year 2) Planned interim analysis 36 months (year 3) Planned final analysis Up to 3 years of follow-up
Full PATHFINDER-2 Results Were Strong & Consistent With the First 25k 17 Performance metrics Cancer detection rate Safety ~60% PPV ~0.4% False Positive Rate >90% CSO accuracy >70% Episode sensitivity for 12 deadly cancers 6.5x cancers detected When added to USPSTF A/B screenings(1) 3x cancers detected When added to all SOC screenings(1) No serious study-related adverse events 85% diagnostic evaluations were non-invasive <1% participants had an invasive procedure Invasive procedures were more common in cancer vs. no cancer (91% vs. 50%) >70% Galleri detected cancers were Stage I-III and ~50% were Stage I-II (1) SOC screening includes Breast, Lung, Colon, Cervix, and Prostate; USPSTF A/B Screenings are: Breast, Lung, Colon and Cervix. Prostate cancer has a USPSTF C rating.
Summary 18
Strong and Consistent Performance Across ~180,000 Participants in NHS-Galleri & PATHFINDER 2 First demonstration of stage shift after 3 years of MCED screening • >20% reduction in stage IV cancers after the first screening year • Increase in stages I and II cancers • 25% fewer cancers were diagnosed after an emergency presentation Adding Galleri to SOC enables detection of substantially more cancers Consistently high performance that enables confident, real-world use Actionable results that drive efficient, patient-centered care • Between 4x and 6.5x the number of cancers detected when added to standard-of- care screening • Enables detection of deadly cancers without existing screening options • Consistent results across studies • ~60% PPV for PATHFINDER 2 and >50% PPV in the first screening year for NHS- Galleri • Less than 0.5% False Positive Rate • Consistently accurate (~90% or higher) cancer signal origin prediction enables rapid, directed diagnostic resolution 19
Q&A 20
FAQ
What changes did GRAIL (GRAL) make to CEO Joshua Ofman’s compensation?
GRAIL set Dr. Joshua Ofman’s annual base salary at $800,000 and increased his variable compensation plan target to 100% of salary from June 1, 2026. He will also receive $2,000,000 in RSUs vesting over four years, plus enhanced severance protections.
What severance protections does GRAIL’s CEO receive in a change in control?
If terminated without cause or resigning for good reason during the change-in-control period, Dr. Ofman is entitled to 24 months of salary, a cash payment equal to 200% of target bonus, full vesting of equity awards, and up to 24 months of company-paid COBRA healthcare coverage.
How large was the NHS-Galleri trial highlighted by GRAIL (GRAL)?
The NHS-Galleri trial enrolled 142,826 participants randomized to standard screening alone or standard screening plus Galleri. It evaluated three annual screening rounds and follow-up, focusing on 12 deadly cancer types and measuring shifts in cancer stage at diagnosis and presentation patterns.
What stage shift did Galleri produce in the NHS-Galleri trial?
In the NHS-Galleri trial, adding Galleri led to more than a 20% reduction in Stage IV cancers in incident screening rounds and about a 16% increase in Stage I/II cancers among 12 prespecified deadly cancer types, indicating more cancers were found at earlier, potentially more treatable stages.
What were Galleri’s accuracy and false positive rate in GRAIL’s studies?
Across NHS-Galleri, Galleri achieved a positive predictive value of about 52%, episode sensitivity of 54.7% for 12 deadly cancers, and cancer signal origin accuracy of 92.5%. The false positive rate was approximately 0.45%, with no serious study-related adverse events reported.
How did Galleri affect screening-detected cancer numbers versus standard screening?
Adding Galleri to standard-of-care screening approximately quadrupled the number of screening-detected cancers compared with standard screening alone. It also contributed to 21% fewer clinically detected cancers and a 25% reduction in cancers first diagnosed through emergency presentation in the NHS-Galleri study.