GRAIL, Inc. (GRAL) SEC Filings & Earnings Calls

Royalty obligation resumption

“We expect that the royalty payments we will make to Illumina in the foreseeable future will result in a 7% royalty rate. The royalty obligation is currently suspended until December 24, 2026.” · word for word

Continued operating losses

“We expect to continue to incur operating losses over at least the next several years as we continue to invest in research and development and seek to achieve broad reimbursement of our current commercialized products.” · word for word

Future capital needs

“We anticipate that we will need to raise additional financing in the future to fund our operations.” · word for word

Regulatory risk: FDA advisory committee outcome uncertain; PMA approval not guaranteed.

“We anticipate an FDA advisory committee in the fall to review the Premarket Approval (PMA) application.” · word for word

Commercialization risk: Expansion into Asian markets subject to regulatory approvals.

“GRAIL and Samsung C&T intend to collaborate to commercialize the Galleri test in South Korea... subject to regulatory approvals and other conditions.” · word for word

CEO transition risk; potential disruption during leadership change.

“Appointment of new CEO effective June 1, 2026.”

Royalty Payment Obligation

“We expect that the royalty payments we will make to Illumina in the foreseeable future will result in a 7% royalty rate. ... had we been required to pay the royalty to Illumina for the three month period ended March 31, 2026, we would have made payments of $2.9 million.” · word for word

Lack of Broad Reimbursement

“Galleri is not currently broadly reimbursed.” · word for word

Continued Operating Losses

“We expect to continue to incur operating losses over at least the next several years” · word for word

Samsung Investment Closing Risk

“The Samsung Investment has not closed, and remains subject to the satisfaction of certain closing conditions set forth in the Samsung Stock Purchase Agreement, including, but not limited to the satisfaction of certain regulatory approvals or clearances, including with respect to the Committee on Foreign Investment in the United States.” · word for word

Still generating significant operating losses with negative adjusted EBITDA of $79.9M

“Adjusted EBITDA was $(79.9) million” · word for word

Gross loss of $14.3M indicates cost of revenue still exceeds revenue

“Gross loss was $14.3 million” · word for word

NHS-Galleri Trial Primary Endpoint Miss

“In February 2026, we announced topline results from the NHS-Galleri Trial, which did not achieve its primary endpoint of statistically significant combined Stage 3 and 4 cancer reduction.” · word for word

Dependence on Galleri for Substantial Majority of Revenue

“Sales of Galleri accounted for a substantial majority of our revenue to date and we expect that such sales will continue to account for the substantial majority of our revenue for the foreseeable future.” · word for word

Sole Supplier Dependency on Illumina

“We rely on Illumina as the sole supplier of the next-generation sequencers and associated Illumina-supplied reagents we use to perform our genomic tests and as the sole provider of servicing, including maintenance and repair services for these sequencers.” · word for word

Uncertainty of FDA Approval and Medicare Coverage

“We are pursuing a PMA with the FDA for a further updated version of Galleri... The NCD process can be lengthy and resource-intensive, and its timing, outcome, and scope are inherently uncertain...” · word for word

Need for Additional Financing

“We will require additional capital to expand the commercialization of Galleri and our precision oncology portfolio, and for the development and commercialization of future products.” · word for word

NHS-Galleri trial missed primary endpoint, though secondary benefits observed.

“the trial did not meet the primary endpoint of a statistically significant reduction” · word for word

Continued net losses and negative adjusted EBITDA, though improving.

“Net loss was $99.2 million; Adjusted EBITDA was $(71.8) million”

Preliminary results subject to change; final audited results may differ.

“These amounts are preliminary, have not been subject to review by the Company's independent registered public accounting firm” · word for word

Cash burn still significant despite improvement.

“Cash Burn3 $126M 2025”

Potential dilution from at-the-market equity offering program.

“Equity Distribution Agreement with investment banks.”

Samsung Investment Closing Risk

“The Samsung Investment is subject to closing conditions, including conditions beyond our control, and no assurance can be given that closing will take place on the timeline currently anticipated, or at all” · word for word

Clinical Trial Data Risk

“Various factors are likely to cause the final results to differ from the prevalent screening round results.” · word for word

Competitive Pressure

“There are market participants in the cancer detection space both in the United States and abroad, including Exact Sciences Corporation and Guardant Health, Inc., who have each introduced MCED products into the market in 2025.” · word for word

FDA Staffing Reductions

“In April 2025 approximately 3,500 FDA staff positions were eliminated.” · word for word

Still generating significant operating losses; path to profitability uncertain.

“Net loss $89M, adjusted EBITDA $(71.7)M.”

FDA PMA submission not yet completed; regulatory risk.

“Galleri PMA submission to FDA now anticipated in Q1 2026.” · word for word