Key Highlights

  • Galleri test sales rose 14%, reaching USD 37.3 million, while total Revenue increased 4% to USD 37.5 million in the quarter ending in September 2026.
  • Test Volume rose roughly 24% to over 56,000 tests in the period, and the nine-month count reached more than 174,000, up about 36%.
  • The net loss widened by USD 14.6 million, or 16%, from a year earlier to USD 103.6 million, and adjusted EBITDA came in at a negative USD 92.6 million.
  • Cash plus short-term marketable securities stood at USD 788.7 million on September 30, 2026, and an FDA decision on Galleri is anticipated by early Q1 2027.

Test Volume Outpaces Revenue Growth in the Quarter

GRAIL (NASDAQ:GRAL) published third-quarter 2026 figures on November 4, 2026. Total revenue reached USD 37.5 million, an increase of USD 1.3 million, or 4%. Galleri, the company's blood-based screen that detects fragments of DNA released by cancer cells, accounted for USD 37.3 million, rising 14% as volume grew about 24%. Management pointed to promotional pricing efforts, though the release does not put a figure on that effect. For the first nine months, Galleri volume climbed about 36% and revenue rose 24% to USD 119.7 million. Volume outpacing revenue suggests lower average pricing per test in the period, though the release does not confirm this. The release contains no revenue guidance and no per-share loss figure.

Wider Losses Run Alongside a Favorable Advisory Vote

The net loss totaled USD 103.6 million, up 16% year over year. The gross loss widened to USD 18.1 million, and adjusted Gross Profit dropped 20% to USD 15.9 million. The adjusted EBITDA loss reached USD 92.6 million, a 29% jump. Offsetting the financial strain, the FDA's Molecular and Clinical Genetics Panel, part of the Medical Device Advisory Committee, backed approval of Galleri in September. That vote is advisory, since Galleri has not been cleared or approved and the agency is free to reach a different conclusion. Adjusted EBITDA, a non-GAAP measure, strips out certain non-cash and other items from the GAAP figure. The company expects an FDA decision by early Q1 2027.

Clinical Results, a USD 115.7 Million Cash Decline and the 2027 Watch List

The company cites findings from NHS-Galleri and PATHFINDER 2, two studies that together enrolled about 175,000 participants and produced four to 6.5 times more cancers detected. In the NHS-Galleri trial, Stage IV diagnoses fell by more than 20% across 12 prespecified aggressive cancers. Cash and short-term securities were USD 788.7 million at quarter end, down from about USD 904.4 million at December 31, 2025, a decline of roughly USD 115.7 million (calculated). Of the balance, USD 29.0 million sat in cash, while the remaining USD 759.7 million was parked in short-term marketable securities. Reimbursement and wider access remain unresolved in the release.

Where Things Stand

It can, but only if the FDA decision and reimbursement go the company's way, and neither is settled. Galleri revenue expanded 14% and volume climbed about 24%, and the advisory committee's stance was positive, yet the quarter still produced a USD 103.6 million net loss. The USD 788.7 million of cash and securities funds the path forward. Watch for the regulator's ruling, which the company expects in the opening weeks of 2027, along with fourth-quarter test counts and reimbursement news.