GRAL — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Strategic Collaboration with Samsung and Closing of $110 million Equity Investment

• In June we completed our previously announced issuance and sale of an aggregate of 1,570,308 shares of our common stock to Samsung C&T Corporation (“Samsung C&T”) and Samsung Electronics Singapore Pte. Ltd. in a private placement at a purchase price of $70.05 per share, for aggregate gross proceeds …

• In connection with this investment, our strategic collaborations with Samsung C&T and Samsung Electronics Co., Ltd. (“Samsung Electronics”) became effective. We intend to work with Samsung C&T as exclusive partners to commercialize Galleri in Korea and, potentially, other key Asian markets, includin…

• •FDA and other regulatory approval and reimbursement. Our performance will be impacted by the extent to which we can secure reimbursement and coverage for Galleri. Prior to broader coverage and reimbursement in the United States, we will continue our work with clinics and health systems to accelerat…

• •International expansion. A component of our long-term growth strategy is to expand our commercial reach internationally. We continue to evaluate international expansion opportunities and we have begun expansion in select additional geographies through distributors, including Israel, Canada and the …

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• GRAIL was previously acquired by Illumina, Inc. (”Illumina”) in August 2021, at which point it became a 100% owned subsidiary of Illumina, and held separate as a part of binding hold separate commitments implemented pursuant to orders issued by the European Commission (the “Acquisition”).

• On June 24, 2024, Illumina completed a Spin-Off (the “Spin-Off”) through the distribution of shares of GRAIL’s common stock to Illumina stockholders. In connection with the Spin-Off, the Company entered into several agreements with Illumina that govern the relationship of the parties following the S…

• •FDA and other regulatory approval and reimbursement. Our performance will be impacted by the extent to which we can secure reimbursement and coverage for Galleri. Prior to broader coverage and reimbursement in the United States, we will continue our work with clinics and health systems to accelerat…

• (“CMS”) to initiate coverage as early as January 1, 2029 for the aged 50-65 Medicare population and expanding one age-year at a time annually. If we obtain FDA approval, we expect to pursue coverage through this new law and, subsequently, inclusion of Galleri in the United States Preventive Services…

• •International expansion. A component of our long-term growth strategy is to expand our commercial reach internationally. We have expanded our research internationally into the United Kingdom through our partnership with NHS England in the NHS-Galleri Trial, and we expect to launch Galleri in the Un…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• We are exposed to market risk related to changes in interest rates related primarily to our cash, cash equivalents and marketable securities. We had cash and cash equivalents of $55.6 million as of June 30, 2026,

• which consisted primarily of bank deposits, money market funds and marketable securities. As of June 30, 2026, we had short-term marketable securities of $806.0 million. Our marketable securities are held in U.S. government treasury bills. Our primary exposure to market risk is interest income sensi…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• We are exposed to market risk related to changes in interest rates related primarily to our cash, cash equivalents and marketable securities. We had cash and cash equivalents of $69.3 million as of March 31, 2026, which consisted primarily of bank deposits, money market funds and marketable securiti…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Form 10‑Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a‑15(e) and 15d‑15(e) under the Exchange Act…

Text removed vs the prior filing · source: 10-Q · 2026-05-07

• the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.

• Our management, with the participation of our principal executive officer and principal financial officer, evaluated, as of the end of the period covered by this Form 10‑Q, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a‑15(e) and 15d‑15(e) under the Exchange Act…

Text added vs the prior filing · source: 10-Q · 2026-08-06

• Our business, financial condition and operating results are affected by a number of factors, whether currently known or unknown, including risks specific to us or the healthcare industry as well as risks that affect businesses in general. In addition to the information set forth in this Form 10-Q, y…

• These risk factors may be important to understanding other statements in this Form 10-Q and should be read in conjunction with the unaudited condensed consolidated financial statements and related notes in Part I, Item 1, “Financial Statements” and Part I, Item 2, “Management’s Discussion and Analys…

• We could be subject to additional securities class action litigation.

• Securities class action litigation is often brought against a company following a decline in the market price of its securities. Our stock price may be volatile and may decline significantly in response to the announcement of clinical trial results, including results that do not meet their primary e…

• In addition, any perceived or actual decline in our business prospects or stock price following the NHS-Galleri Trial results or other adverse developments could invite shareholder activism. Responding to shareholder activism can be costly and time-consuming, disrupt our operations, and divert the a…