The Tip Desk

Earnings

GRAIL's Galleri Growth Slows in Third Quarter

Third-quarter Galleri revenue was $37.3 million, up 14% from a year earlier, as test volume rose about 24% to more than 56,000.

GRAIL, Inc. (GRAL), a healthcare company developing the Galleri multi-cancer early detection test, reported that year-over-year growth in both Galleri test volume and Galleri revenue slowed in the third quarter after two faster periods.

Galleri test volume increased approximately 24% from a year earlier to more than 56,000 tests. Galleri test revenue grew 14% to $37.3 million. Total revenue, which includes screening and development services, rose 4% to $37.5 million.

The sequential slowdown was the quarter’s defining commercial turn. In the second quarter, Galleri volume had grown 35% to more than 61,000 tests and Galleri revenue had grown 24% to $42.6 million, with total revenue up 26% to $44.7 million. In the first quarter, Galleri volume growth was 50% to more than 56,000 tests, Galleri revenue growth was 37% to $39.8 million, and total revenue growth was 28% to $40.8 million.

Screening revenue was $37.3 million in the three months ended September 30, 2026, versus $32.8 million a year earlier. Development services revenue was $0.3 million, down from $3.4 million a year earlier.

Chief Executive Officer Josh Ofman said the company achieved a favorable vote for approval of Galleri at the FDA’s Molecular and Clinical Genetics Panel of the Medical Device Advisory Committee in September. GRAIL separately said it anticipates an FDA decision by early first quarter 2027. He said commercial momentum continued as positive advancements, market education, and promotional pricing initiatives gained traction.

Gross loss widened to $18.1 million from $12.6 million in the second quarter and $14.3 million in the first quarter. Adjusted gross profit declined to $15.9 million from $21.6 million in the second quarter and $19.7 million in the first quarter. Adjusted gross margin was 42%, compared with 55% a year earlier.

Net loss was $103.6 million, or $2.21 a share, versus $110.2 million in the second quarter and $93.2 million in the first quarter. Adjusted EBITDA loss was $(92.6) million, wider than $(90.3) million in the second quarter and $(79.9) million in the first quarter.

Sales and marketing expense rose to $41.7 million from $25.5 million a year earlier. Research and development expense was $44.1 million and general and administrative expense was $40.7 million.

Cash, cash equivalents, and short-term marketable securities totaled $788.7 million as of September 30, 2026, down from $861.6 million at June 30, 2026 and $823.1 million at March 31, 2026.

The company also published results from the NHS-Galleri trial and final results from PATHFINDER 2, covering approximately 175,000 participants in the UK and North America. GRAIL said the studies showed 4- to 6.5-fold more cancers detected, a greater than 20% reduction in Stage IV diagnoses of 12 prespecified aggressive cancers in NHS-Galleri, and a 25% reduction in cancers diagnosed after emergency presentation in the Galleri arm versus control. Galleri added to standard-of-care screening detected more Stage I-II cancers than the UK national screening program found across all stages, the company said.

For the nine months ended September 30, 2026, Galleri volume grew 36% year-over-year to more than 174,000 tests and Galleri revenue grew 24% to $119.7 million.

The Galleri test has not been cleared or approved by the FDA. GRAIL’s clinical laboratory is CLIA-certified and CAP-accredited.

More on GRAL

GRAIL, Inc. — all coverage and financials