MENLO PARK, Calif., Dec. 3, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that it has granted equity awards in the form of restricted stock units ("RSUs") underlying an aggregate of 115,093 shares of GRAIL's common stock to 46 recently hired non-executive employees as an inducement material to their acceptance of employment with GRAIL. The employment inducement awards were granted under GRAIL's Inducement E ...

MENLO PARK, Calif., Nov. 19, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will participate in the following investor conferences. Piper Sandler 36th Annual Healthcare Conference in New York, NY: fireside chat on Tuesday, Dec. 3 at 1:30 p.m. ET 7th Annual Evercore ISI HealthCONx Conference in Coral Gables, Fla.: fireside chat on Wednesday, Dec. 4 at 3:50 p.m. ETLive and replay webcas ...

Core Viewpoint - GRAIL, Inc. has initiated patient testing for its investigational ctDNA assay in a Phase 3 study aimed at improving treatment selection for early-stage non-small cell lung cancer (NSCLC) patients, in collaboration with AstraZeneca and Daiichi Sankyo [1][2][3]. Group 1: Study Details - The TROPION-Lung12 study is designed to evaluate adjuvant treatment regimens for patients with Stage I adenocarcinoma NSCLC, utilizing GRAIL's ctDNA assay to screen patients prior to surgery [1][2]. - The study is conducted under an FDA-approved Investigational Device Exemption application, allowing for the integration of GRAIL's blood-only assay into clinical trial workflows without the need for tissue analysis [2][3]. Group 2: Technology and Innovation - GRAIL's targeted methylation platform is employed to detect circulating tumor DNA (ctDNA), which is expected to enhance patient selection for cancer treatment by identifying those at increased risk of disease recurrence [2][3]. - The ctDNA detection method offers a rapid and accessible approach for oncologists, potentially refining diagnostic and prognostic profiles for better-guided cancer therapy [3]. Group 3: Strategic Collaboration - GRAIL has a strategic collaboration with AstraZeneca to develop and commercialize companion diagnostic assays, focusing on leveraging blood-based methylation testing for precision oncology [3]. - The collaboration aims to utilize early insights from ctDNA detection to enable personalized treatment decisions, benefiting patients diagnosed with Stage 1 lung cancer [3]. Group 4: Company Overview - GRAIL is dedicated to early cancer detection using next-generation sequencing and advanced machine learning, aiming to alleviate the global burden of cancer [4]. - The company’s platform supports various aspects of cancer care, including multi-cancer early detection, risk stratification, and treatment monitoring [4].

Financial Data and Key Metrics Changes - Revenue for Q3 2024 was $28.7 million, an increase of $7.9 million or 38% compared to Q3 2023 [16] - Screening revenue was $25.4 million, up 52% from Q3 2023, driven by increased sales volume [18] - Net loss for the quarter was $125.7 million, an improvement of 86% compared to Q2 2023 [19] - Non-GAAP adjusted gross profit for Q3 2024 was $11.8 million, an increase of $4.8 million or 68% compared to Q3 2023 [21] - Adjusted EBITDA for Q3 2024 was a negative $108.2 million, representing an improvement of $17.9 million or 14% compared to Q3 2023 [21] - Cash position at the end of the quarter was $853.6 million [21] Business Line Data and Key Metrics Changes - Approximately 32,600 Galleri tests were sold in Q3 2024, reflecting continued demand [18] - Development services revenue was $3.3 million, which includes services provided to biopharmaceutical and clinical customers [17] Market Data and Key Metrics Changes - Over 250,000 commercial Galleri tests have been prescribed by more than 12,000 healthcare providers since launch [9] - A cancer signal detection rate of 1.3% was observed in a study of 2,800 veterans, with a positive predictive value of 42.9% [14] Company Strategy and Development Direction - The company aims to improve cancer care and enable broad use of Galleri, focusing on FDA approval and pursuing broad reimbursement [24] - A new version of the Galleri test is expected to launch at the end of the year, featuring significant automation and cost reductions [10][29] - The company plans to moderate cash burn and extend its cash runway into 2028 while prioritizing FDA approval and reimbursement [22][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the demand for Galleri and the potential for future growth, despite the challenges of being an unreimbursed test [9][30] - The company is encouraged by bipartisan support for legislation that could facilitate CMS coverage for FDA-approved tests [30] Other Important Information - The company is narrowing its guidance for Galleri sales growth in 2024 to between 40% and 50% compared to 2023 [22] - The expected timeline for FDA approval is tentatively set for the first half of 2027 [28] Q&A Session Summary Question: Progress on Galleri reimbursement and FDA regulatory pathway - Management discussed the completion of study visits for key registrational studies and the expected timeline for PMA submission in the first half of 2026, with FDA approval anticipated in the first half of 2027 [27][28] Question: Managing commercial efforts and cash balance - The company is focusing on extending its cash runway while moderating investment in commercial efforts to ensure that margins generated can cover expenses [33][34] Question: Building the MCED market before reimbursement - Management emphasized the importance of integrating Galleri into standard practices and building provider comfort with the test [38] Question: Performance differences in version 2 of Galleri - Minor improvements in performance are expected, but the main focus is on scalability and cost reduction [42] Question: Phasing of cash burn through 2025 - Cash burn is expected to decrease as revenues grow, with a gradual ramp-up in cost reductions from the new version of Galleri [45][46]

Financial Performance - GRAIL incurred net losses of $125.7 million and $891.4 million for the three months ended September 30, 2024 and October 1, 2023, respectively, and $1.9 billion and $1.3 billion for the nine months ended September 30, 2024 and October 1, 2023, respectively[133]. - Adjusted EBITDA for the three months ended September 30, 2024 was $(108.2) million, compared to $(126.1) million for the same period in 2023[133]. - The company recorded a net loss of $891,448,000 for the three months ended September 30, 2024, compared to a net loss of $1,278,158,000 for the same period in 2023[170]. - Total revenue for the three months ended September 30, 2024, was $28,652,000, representing a 38% increase from $20,722,000 for the same period in 2023[172]. - Total revenue for the nine months ended September 30, 2024, was $87,343,000, representing a 39% increase from $62,779,000 for the same period in 2023[184]. - Adjusted EBITDA for the nine months ended September 30, 2024, was $(399.5) million, slightly improved from $(400.4) million for the same period in 2023[206]. - The company incurred net losses of $9.7 billion since the acquisition of GRAIL, which includes significant charges for impairment of goodwill and intangible assets[211]. Revenue and Sales - Screening revenue increased by $8,629,000, or 52%, primarily due to a 57% increase in Galleri sales volume, despite a 3% decrease in average selling price[172]. - Screening revenue increased by $24,732,000, or 47%, primarily due to a rise in Galleri sales volume, which was consistent in average selling price (ASP) period over period[184]. - The company recognizes revenue from cancer screening testing services at the point when test results are delivered to the ordering physician[223]. Restructuring and Cost Management - GRAIL's restructuring plan aims to reduce headcount by approximately 30%, including 350 full-time employees, which is expected to save about $120 million annually[140]. - The company expects to incur restructuring charges of approximately $19.0 million to $23.0 million through the fourth quarter of 2024[141]. - Sales and marketing expenses are expected to decrease immediately following the implementation of the Restructuring Plan and to continue decreasing as a percentage of revenue over the next three years[162]. - The company expects research and development expenses to decrease over the next three years as it reduces investment in product programs beyond Galleri[161]. Cash and Funding - As of September 30, 2024, the company's cash and cash equivalents totaled $853.6 million, following a cash contribution of $932.3 million from Illumina[210]. - The company received $1.2 billion in funding from Illumina during the nine months ended September 30, 2024, a significant increase from $378.0 million in the same period in 2023[217]. - Net cash used by operating activities for the nine months ended September 30, 2024, was $(483.7) million, compared to $(466.9) million for the same period in 2023[213]. - The company may need to raise additional financing in the future to fund operations, which could result in dilution for existing stockholders[212]. Research and Development - The company plans to continue investing in biopharmaceutical partnerships and leverage proprietary methylation technology in precision oncology applications[139]. - The company has invested heavily in clinical studies, including the NHS-Galleri Trial, which is expected to provide results in 2026 and could facilitate adoption in other single-payer systems globally[153]. - Research and development expenses rose by $19,393,000, or 8%, driven by increased laboratory supplies and compensation expenses[188]. - The company accrues for estimated costs of research and development activities based on the estimated amount of services provided, which are significant components of its R&D expenses[228]. Regulatory and Market Position - GRAIL's Galleri test is not yet approved by the U.S. Food and Drug Administration but is clinically validated based on studies involving over 21,000 participants[132]. - The company plans to complete a PMA submission with the FDA in the first half of 2026, which is subject to various risks and could take several years to obtain approval[148]. - The company is actively working with the FDA to determine the necessary data for PMA submission, which may change over time, complicating the approval process[148]. - Galleri is currently available as a laboratory developed test in the United States, with private reimbursement established from several self-insured employers and health plans, but lacks broader coverage from government healthcare programs like Medicare[148]. Goodwill and Impairment - The company recognized a goodwill impairment charge of $718,466,000 in the third quarter of 2023, which was not present in the current quarter[180]. - The company recorded a goodwill impairment charge of $888,900,000, reflecting a significant decrease in the fair value of GRAIL[192]. - Goodwill represents the costs in excess of the fair value of net assets of GRAIL acquired by Illumina in August 2021[232]. - The company tests goodwill and indefinite-lived intangible assets for impairment annually or more frequently if circumstances change[233]. International Expansion - The company is focused on international expansion, particularly in the United Kingdom, and is evaluating additional select geographies for future growth[149]. - The company aims to leverage its scalable infrastructure to meet increasing demand and improve margins over time[154].

Galleri Revenue Grew 52% Year-Over-Year to $25.4 Million Commercial Galleri Sales Surpassed 250,000 Tests Since Launch Cash Balance of $853.6 Million Provides Runway Into 2028 MENLO PARK, Calif., Nov. 12, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the third quarter 2024. Revenue in the third quarter was $28.7 million, representing 38% growth year over year, and revenue f ...

NEWS RELEASE Exhibit 99.1 GRAIL Reports Third Quarter 2024 Financial Results Galleri Revenue Grew 52% Year-Over-Year to $25.4 Million Commercial Galleri Sales Surpassed 250,000 Tests Since Launch Cash Balance of $853.6 Million Provides Runway Into 2028 MENLO PARK, Calif. — Nov. 12, 2024 — GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today reported business and financial results for the third quarter 2024. Revenue in the third quarter was $28. ...

MENLO PARK, Calif., Nov. 4, 2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced that company management will present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum in New York on Thursday, Nov. 21 at 11:00 a.m. ET. Live and replay webcasts may be accessed in the investor relations section of GRAIL's website at investors.grail.com. The webcast will be archived and available for r ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |----------------------------------------------- ...

[Financial & Business Highlights](index=1&type=section&id=Financial%20%26%20Business%20Highlights) GRAIL reported strong Q2 2024 revenue growth and significant clinical trial progress, despite a substantial net loss due to impairment charges [Q2 2024 Financial Performance](index=1&type=section&id=Q2%202024%20Financial%20Performance) GRAIL reported strong revenue growth of 43% year-over-year to $32.0 million for the second quarter of 2024, but recorded a significant net loss of $(1.59) billion primarily due to a $1.42 billion impairment charge Q2 2024 Financial Highlights (vs. Q2 2023) | Financial Metric | Q2 2024 | Q2 2023 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $32.0 million | $22.4 million | +43% | | **Gross Loss (GAAP)** | $(17.9) million | $(24.3) million | +26% improvement | | **Net Loss (GAAP)** | $(1.59) billion | $(193.0) million | +721% increase | | **Adjusted Gross Profit (Non-GAAP)** | $16.0 million | $9.6 million | +66% | | **Adjusted EBITDA (Non-GAAP)** | $(139.4) million | $(136.5) million | -2% | - The significant increase in net loss was primarily driven by a goodwill and intangible impairment charge of **$1.42 billion**[3](index=3&type=chunk) - As of June 30, 2024, cash and cash equivalents totaled **$958.8 million**[3](index=3&type=chunk) - This is the company's first quarterly report as an independent public company following its separation from Illumina on June 24, 2024, with over **215,000 Galleri® tests** sold as of June 30[2](index=2&type=chunk) [Recent Business Highlights](index=2&type=section&id=Recent%20Business%20Highlights) GRAIL has achieved significant milestones in its major clinical trials, including commencing enrollment for REACH and completing enrollment for PATHFINDER 2 and final visits for NHS-Galleri - Began enrollment in the REACH (Galleri-Medicare) study, which will enroll **50,000 individuals** from the Medicare population to provide clinical validation and utility data[4](index=4&type=chunk) - Completed enrollment of over **35,000 participants** in the registrational PATHFINDER 2 study, evaluating Galleri's safety and performance in individuals aged 50 and older[4](index=4&type=chunk) - Completed final study visits for the NHS-Galleri trial, a large-scale randomized controlled trial with over **140,000 participants** in the UK[4](index=4&type=chunk) [Strategic Update & Outlook](index=2&type=section&id=Strategic%20Update%20%26%20Outlook) GRAIL is implementing a corporate restructure to prioritize core MCED initiatives, reducing costs and extending its financial runway into 2028 [Portfolio Prioritization and Corporate Restructure](index=2&type=section&id=Portfolio%20Prioritization%20and%20Corporate%20Restructure) Following a portfolio review, GRAIL is implementing a corporate restructure to focus resources on its core multi-cancer early detection (MCED) priorities, particularly the Galleri test - The company is reducing overall spending to focus on core MCED priorities, including completing registrational studies and the premarket approval (PMA) application submission for Galleri[5](index=5&type=chunk) - Restructuring includes a reduction of approximately **30%** in existing headcount and planned hires for 2024[6](index=6&type=chunk) - Commercial operations will be refocused on the most productive provider territories, with streamlined investments in the enterprise business (employer and life insurance)[6](index=6&type=chunk) - Investment in biopharmaceutical partnerships will continue, leveraging GRAIL's methylation technology for precision oncology applications[6](index=6&type=chunk) [Financial Outlook](index=2&type=section&id=Financial%20Outlook) The strategic cost reductions are projected to significantly improve GRAIL's financial runway, extending it from the second half of 2026 into 2028 - The cost reduction measures are expected to extend the company's cash runway from **H2 2026 into 2028**[7](index=7&type=chunk) - The company anticipates reducing its cash burn to **$325 million** in 2025[7](index=7&type=chunk) - Expected savings in 2024 are **$27 million**, net of anticipated severance and benefits costs[7](index=7&type=chunk) [Financial Statements & Reconciliations](index=4&type=section&id=Financial%20Statements%20%26%20Reconciliations) This section provides detailed financial statements including balance sheets, income statements, cash flow statements, and reconciliations of GAAP to non-GAAP financial metrics [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2024, GRAIL's total assets were **$3.27 billion**, a decrease from **$3.91 billion** at the end of 2023, largely due to the complete impairment of goodwill Selected Balance Sheet Data (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $958,845 | $97,287 | | **Intangibles assets, net** | $2,086,056 | $2,687,223 | | **Goodwill** | $0 | $888,936 | | **Total assets** | $3,269,640 | $3,913,814 | | **Total liabilities** | $574,513 | $267,627 | | **Total stockholders' equity** | $2,695,127 | $3,646,187 | [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2024, GRAIL generated **$32.0 million** in total revenue, a 43% increase, but reported a net loss of **$(1.59) billion** primarily due to a **$1.42 billion** impairment charge Statement of Operations Summary - Three Months Ended (in thousands, except per share data) | Account | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Total revenue** | $31,970 | $22,414 | | **Goodwill and intangible impairment** | $1,420,936 | $0 | | **Loss from operations** | $(1,641,291) | $(204,367) | | **Net loss** | $(1,585,337) | $(193,044) | | **Net loss per share** | $(51.06) | $(6.22) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2024, net cash used in operating activities was **$(379.1) million**, with a net increase in cash of **$861.3 million** primarily from financing activities, ending with **$962.8 million** in cash Cash Flow Summary - Six Months Ended (in thousands) | Activity | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Net cash used by operating activities** | $(379,085) | $(309,391) | | **Net cash used by investing activities** | $(3,934) | $(5,923) | | **Net cash provided by financing activities** | $1,244,300 | $303,775 | | **Net increase (decrease) in cash** | $861,251 | $(11,282) | | **Cash, cash equivalents and restricted cash — end of period** | $962,763 | $234,846 | [Reconciliation of GAAP to Non-GAAP Financial Measures](index=9&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Financial%20Measures) This section details the adjustments made to arrive at non-GAAP metrics, such as Adjusted Gross Profit and Adjusted EBITDA, by excluding specific non-cash or non-recurring expenses for comparable operational performance assessment - Adjusted Gross Profit is used by management to assess operational performance by excluding indirect costs, amortization, and stock-based compensation from the cost of revenue[16](index=16&type=chunk)[17](index=17&type=chunk) - Adjusted EBITDA is used to assess financial performance and for internal planning, providing a comparable overview by excluding items like capital structure, tax rates, and certain non-cash or non-recurring expenses[18](index=18&type=chunk)[19](index=19&type=chunk) [Reconciliation to Adjusted Gross Profit](index=9&type=section&id=Reconciliation%20to%20Adjusted%20Gross%20Profit) For Q2 2024, a GAAP gross loss of **$(17.9) million** was reconciled to a non-GAAP Adjusted Gross Profit of **$16.0 million**, representing a 66% increase from Q2 2023 Reconciliation to Adjusted Gross Profit - Three Months Ended (in thousands) | Line Item | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Gross loss (GAAP)** | $(17,912) | $(24,278) | | Amortization of intangible assets | $33,472 | $33,472 | | Stock-based compensation | $463 | $450 | | **Adjusted Gross Profit (Non-GAAP)** | **$16,023** | **$9,644** | [Reconciliation to Adjusted EBITDA](index=10&type=section&id=Reconciliation%20to%20Adjusted%20EBITDA) For Q2 2024, the GAAP net loss of **$(1.59) billion** was reconciled to a non-GAAP Adjusted EBITDA of **$(139.4) million**, with the largest adjustment being the exclusion of the **$1.42 billion** impairment charge Reconciliation to Adjusted EBITDA - Three Months Ended (in thousands) | Line Item | June 30, 2024 | July 2, 2023 | | :--- | :--- | :--- | | **Net loss (GAAP)** | $(1,585,337) | $(193,044) | | Goodwill and intangible impairment | $1,420,936 | $0 | | Benefit from income tax expense | $(53,144) | $(9,796) | | Amortization of intangible assets | $34,583 | $34,583 | | Stock-based compensation | $25,947 | $25,548 | | Other adjustments (Interest, D&A, etc.) | $17,624 | $6,162 | | **Adjusted EBITDA (Non-GAAP)** | **$(139,391)** | **$(136,545)** |