The revenue miss and decelerating Galleri revenue growth are concerning, but the favorable FDA Advisory Committee vote and anticipated FDA decision by early Q1 2027 are the key catalysts. Monitor cash burn rate and any FDA decision timeline updates.
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Executive Summary
GRAIL reported Q3 2026 total revenue of $37.5M (+4% YoY), below the $44.2M consensus, and GAAP EPS of -$2.21, worse than the consensus estimate of -$1.90. Galleri test volume grew 24% YoY to over 56,000 tests, but revenue growth decelerated to 14% YoY for Galleri. The FDA Advisory Committee voted favorably for Galleri approval in September, with an FDA decision expected by early Q1 2027. Net loss widened to $103.6M from $89.0M a year ago, and cash burn continues with cash and securities at $788.7M.
Key Financial Metrics
Key Facts
- Total revenue $37.5M, +4% YoY, below $44.2M consensus
- Galleri revenue $37.3M, +14% YoY (decelerated from +37% in Q1 2026)
- GAAP EPS -$2.21, worse than consensus -$1.90
- Net loss $103.6M, widened 16% from $89.0M a year ago
- Adjusted EBITDA -$92.6M, loss widened 29% from -$71.7M
- Cash and securities $788.7M as of Sep 30, 2026, down from $823.1M at Mar 31, 2026
- FDA Advisory Committee voted favorably for Galleri approval in September 2026
- FDA decision expected by early Q1 2027
- Galleri test volume +24% YoY to over 56,000 tests in Q3
- Year-to-date Galleri test volume +36% to over 174,000 tests
- Intangible and other assets impairment of $25.4M in Q3 2026
Financial Impact
Revenue miss of $6.7M vs consensus; EPS miss of $0.31; net loss widened by $14.6M YoY; adjusted gross profit declined 20% YoY to $15.9M
Segment Breakdown
| Segment | Revenue | Growth |
|---|---|---|
| Screening revenue | $37.3M | +13.6% |
| Development services revenue | $266.0K | -92.1% |
Risk Factors
- Revenue growth decelerating sharply (total revenue +4% vs +28% in Q1 2026)
- Net loss and adjusted EBITDA losses widening, cash burn continues
- Adjusted gross margin declining to 42% from 55% a year ago
- FDA decision on Galleri PMA is not guaranteed and could be delayed or negative
- Sales and marketing spend increased 63% YoY to $41.7M, outpacing revenue growth
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001628280-26-070118 |
| Document: gral-20261104.htm | 0001628280-26-070118 |
| Document: 0001628280-26-070118-index-headers.html | 0001628280-26-070118 |
| Document: 0001628280-26-070118-index.html | 0001628280-26-070118 |
| Document: 0001628280-26-070118.txt | 0001628280-26-070118 |
| 8-K Data (Synthetic) | 0001628280-26-070118 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Nov 5, 2026 today | SC 13G/A | $119.81 | awaiting T+20 | awaiting T+20 | $119.13 (+0.57%) |
Nov 4, 2026 1d ago | 8-K | $113.84 | awaiting T+20 | awaiting T+20 | $119.13 (−4.65%) |
Nov 2, 2026 2d ago | Institutional Cluster | $139.44 | awaiting T+20 | awaiting T+20 | $119.13 (+14.57%) |
Oct 21, 2026 15d ago | Press Release | $127.06 | awaiting T+20 | awaiting T+20 | $119.13 (−6.24%) |
Sep 23, 2026 6w ago | Insider Cluster | $125.21 $127.06 | ▼ −1.48% | ▼ −1.90% | $119.13 (+4.86%) |
Sep 22, 2026 6w ago | Institutional Cluster | $108.52 $124.67 | ▲ +14.88% | ▲ +15.44% | $119.13 (+9.78%) |
Aug 31, 2026 9w ago | Insider Cluster | $79.79 $140.12 | ▲ +75.61% | ▲ +75.29% | $119.13 (+49.30%) |
Jun 11, 2026 21w ago | Institutional Cluster | $60.16 $75.79 | ▲ +25.98% | ▲ +24.09% | $119.13 (+98.02%) |
Apr 28, 2026 27w ago | DEFA14A | $49.69 $73.92 | ▲ +48.76% | ▲ +42.71% | $119.13 (+139.75%) |
Apr 8, 2026 30w ago | Insider Cluster | $50.78 $54.40 | ▼ −7.13% | ▲ +1.42% | $119.13 (−134.60%) |
US Market Status
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