Previewing the Upcoming GRAL ASCO Late Breaking Presentations

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Previewing the Upcoming GRAL ASCO Late Breaking Presentations

ast, CRC, cervical, and high risk lung cancers).

On our 4Q25 call back, GRAL management elaborated further, • Call Back Color:

explaining that they will conduct statistical analysis of the stage IV reduction, and they

are confident that this will show statistical significance. While the overall PMA for the FDA

is limited to the first 25K PATHFINDER 2 patients, the NHS Galleri prevalent screening

round, and the bridging study, GRAL will also submit a supplemental filing to the FDA that

covers additional analyses such as the NHS Galleri stage IV reduction data. To be clear,

this additional data would be in supplement to the agreed upon PMA package.

At an NDR we hosted in March 2026, GRAL management • Additional NDR Context:

said explicitly that the stage IV reduction in cancers was both clinically and statistically

significant in the NHS study (in line with earlier commentary and language in the 10-

K). Management emphasized that, while the primary endpoint was missed, this stage IV

reduction is still meaningful in other contexts beyond just NHS, especially in US markets.

Stage IV cancers, which are where the line is drawn to be considered metastatic, and

by SEER definitions "distant", have significantly lower survival rates across cancer types

than stage III cancers.

NHS-Galleri ASCO 2026 Presentation Expectations

• Presentation Details:

Title: LBA100 - NHS-Galleri: Primary results from a randomized controlled trial to •

assess the clinical utility of a multi-cancer early detection (MCED) test in population

screening.

Session: Clinical Science Symposium: ctDNA in Clinical Practice: From Detection •

to Clinical Decision-Making. Session includes discussants and Q&A.