Weary of being captive to geopolitics, car companies are looking for ways to replace powerful rare-earth magnets in electric motors. ...

Accessibility StatementSkip Navigation MENLO PARK, Calif., Nov. 18, 2025 /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 Piper Sandler 37th Annual Healthcare Conference on Tuesday, Dec. 2 at 3:00 p.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 re ...

Summary of GRAIL Conference Call Company Overview - **Company**: GRAIL (NasdaqGS:GRAL) - **Industry**: Life Sciences, Diagnostics - **Product**: Galleri Multi Cancer Early Detection Test Key Points from the Conference Call Analyst Day Highlights - GRAIL has seen significant momentum in various market segments, including self-employed insurers and digital health channels [7][8] - Excitement surrounding the Pathfinder 2 data, indicating remarkable assay performance [7][8] - GRAIL has invested in lab capacity to scale testing from over 1 million to 6 million tests annually [8] Regulatory and Reimbursement Pathway - GRAIL plans to submit a Pre-Market Approval (PMA) to the FDA in Q1 2026, with confidence in their data package [10][11] - The submission will include over 90,000 patient records, the largest data set ever submitted for a diagnostic test [11] - FDA is focused on clinical performance and safety, not clinical utility or mortality [16][17] - The cancer detection rate improved seven-fold when Galleri was added to standard care screening [17][25] Clinical Performance Metrics - Galleri shows a positive benefit-risk profile with a positive predictive value (PPV) of 62% and a false positive rate of 0.4% [17][18] - Overall sensitivity for any cancer is 40%, with over 70% sensitivity for the 12 deadliest cancers [18] - No serious adverse events were reported in trials, and diagnostic resolution time was approximately 36 days [18] Commercial Strategy and Financial Outlook - GRAIL is optimistic about commercial momentum and plans to leverage data from NHS-Galleri study for payer discussions [49][56] - The Medicare REACH study for annual testing has been approved, indicating potential for reimbursement [38][39] - The MSAD bill has strong bipartisan support, which could lead to reimbursement starting in 2028 [39][46] Future Milestones - Key milestones for 2026 include FDA submission, NHS-Galleri study readout, and continued commercial momentum [49][50] - GRAIL aims to improve operational efficiency and cost management while expanding into adjacent markets [66][68] Additional Insights - GRAIL is exploring opportunities in the symptomatic population, where reimbursement pathways may be more favorable [71] - The repeat test rate for Galleri has increased to over 30%, indicating strong patient engagement despite lack of reimbursement [75][76] Conclusion GRAIL is positioned for significant growth with its innovative Galleri test, backed by strong clinical data and a proactive approach to regulatory and reimbursement challenges. The company is focused on expanding its market presence while ensuring operational efficiency and financial stability.

Financial Performance - For the three months ended September 30, 2025, GRAIL incurred a net loss of $89.0 million, compared to a net loss of $125.7 million for the same period in 2024[136]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $(248.8) million, an improvement from $(399.5) million for the same period in 2024[136]. - Total revenue for the three months ended September 30, 2025, was $36.2 million, a 26% increase from $28.7 million in the same period of 2024[193]. - Total revenue for the nine months ended September 30, 2025, was $103.6 million, reflecting a $16.2 million, or 19%, increase compared to the same period in 2024[207]. - The company reported a benefit from income taxes of $108.8 million for the nine months ended September 30, 2025, an increase of $3.4 million, or 3%, compared to the prior year[223]. - The company incurred net losses of $10.1 billion since the acquisition of GRAIL by Illumina, including significant impairment charges[238]. Product Development and Clinical Trials - The Galleri test demonstrated a positive predictive value (PPV) of 61.6%, specificity of 99.6%, and cancer signal of origin (CSO) accuracy of 92% in the PATHFINDER 2 study[133]. - The NHS-Galleri Trial involves over 140,000 participants aged 50 to 77 to evaluate Galleri's effectiveness alongside existing NHS screenings[147]. - Data from the NHS-Galleri Trial's prevalent screening round showed a PPV of 43%, CSO accuracy of 88%, and specificity of 99.5%[146]. - The PATHFINDER 2 study enrolled 35,878 adults aged 50 and older, with positive top-line performance results announced for the first 25,578 participants in June 2025[150]. - The Galleri test's cancer signal detection and origin prediction results were compared with standard care pathways, demonstrating the test's performance in symptomatic patients[155]. - The company has invested heavily in clinical studies, including the NHS-Galleri Trial, which is expected to provide results in mid-2026 and could facilitate adoption in other single-payor systems[175]. Strategic Collaborations and Investments - GRAIL announced a strategic collaboration with Samsung C&T to commercialize Galleri in Korea, with potential expansion to Japan and Singapore[137]. - The Samsung collaboration includes a $110 million equity investment at a price of $70.05 per share[138]. - GRAIL received a cash contribution of $932.3 million from Illumina in connection with the Spin-Off, incurring $22.2 million in legal and professional fees related to the transaction[160]. - The company plans to use net proceeds from the Samsung Investment, expected to be approximately $110.0 million, for commercial activities and working capital[235]. Operational Changes and Restructuring - The restructuring plan approved in August 2024 aimed to reduce overall spend by approximately 30% of the workforce, including 350 full-time employees[164]. - The restructuring plan was substantially completed in Q4 2024, incurring total charges of $18.3 million primarily for employee severance and associated costs[165]. - The company expects research and development expenses to decrease over the next three years as it reduces investment in product programs beyond Galleri[177]. - Sales and marketing expenses decreased by $10.1 million to $25.5 million, mainly due to a reduction in compensation expenses related to workforce restructuring[201]. Market and Revenue Insights - Screening revenue increased by $19.2 million, or 25%, to $96.3 million for the nine months ended September 30, 2025, primarily due to a 33% increase in Galleri sales volume[207][208]. - Screening revenue increased by $7.4 million to $32.8 million, driven by a 39% increase in Galleri sales volume, despite a 7% decrease in average selling price (ASP)[194]. - Revenue from Galleri is recognized at the point of time when the test result report is delivered, with pricing generally based on list price and subject to discounts and rebates[178]. Future Outlook and Financing - The company anticipates needing to raise additional financing in the future to support operations and product development[238]. - The company expects to meet its working capital and capital expenditure needs into 2030 with existing cash and securities[238]. - The company plans to submit data from the PATHFINDER 2 study and the NHS-Galleri Trial for premarket approval to the FDA in Q1 2026[153]. - The company plans to complete a PMA submission with the FDA in Q1 2026, which is subject to various risks and may take several years to obtain approval[173]. Cash and Securities Position - As of September 30, 2025, the company had cash and cash equivalents of $126.9 million and short-term marketable securities of $413.2 million, primarily in U.S. government treasury bills[254]. - As of September 30, 2025, the company's cash and cash equivalents totaled $126.9 million, with short-term marketable securities amounting to $413.2 million[234]. Risks and Challenges - The company is exposed to interest rate risk, but a hypothetical 10% change in interest rates would not have a material impact on its financial statements[255]. - The majority of transactions are conducted in U.S. dollars, but the company is subject to foreign exchange risk due to transactions in other currencies, primarily the British pound[256]. - The company does not currently engage in hedging activities to mitigate currency fluctuations but may consider it in the future[256].

Core Insights - GRAIL, Inc. reported Q3 earnings with revenues of $36.2 million, reflecting a 26% year-on-year increase [1] Company Performance - The revenue growth is attributed to the company's flagship cancer testing products [1] Industry Context - The article emphasizes the importance of staying updated on stocks within the biotech, pharma, and healthcare sectors, highlighting key trends and catalysts that influence market valuations [1]

Summary of GRAIL Analyst Day - November 13, 2025 Company Overview - **Company**: GRAIL (NasdaqGS:GRAL) - **Industry**: Multi-Cancer Early Detection (MCED) Testing Key Highlights 1. **Introduction and Purpose**: The Analyst Day aimed to share key business highlights and progress since GRAIL became a public company in June 2024, focusing on population-scale multi-cancer early detection [8][9][10] 2. **Financial Performance**: - Revenue for 2024 was $125 million, with a growth rate of 25% year-over-year for the first nine months of 2025 [12] - A $325 million PIPE financing was announced, providing capital for future growth [13] - Cash burn for the year was reduced to $290 million, with improved margins increasing to 55% from 41% the previous year [14] 3. **Operational Capacity**: GRAIL's lab can run up to 1 million tests, showcasing significant automation and efficiency improvements [12][15] Clinical and Research Insights 1. **Cancer Detection Landscape**: - Cancer is projected to become the leading cause of death globally, surpassing cardiovascular disease [16] - The current screening tests only detect about 14% of incident cancers, generating over 8 million false positives annually in the U.S. [23][24] 2. **Galleri Test Performance**: - The Galleri test has shown a positive predictive value (PPV) of 62% in the PATHFINDER II study, significantly higher than traditional single cancer screening methods [21][32] - The specificity of the Galleri test was reported at 99.6%, minimizing false positives [33] - Episode sensitivity for all cancers was 40.4%, with higher sensitivity for cancers responsible for two-thirds of U.S. cancer deaths at 74% [34] 3. **PATHFINDER II Study**: - Enrolled nearly 35,000 participants, making it the largest interventional MCED study in the U.S. [30] - The study demonstrated that the Galleri test could detect cancers earlier, with 69% of identified cancers being in early stages [36] - The study also showed a low rate of invasive procedures (0.6%) due to positive test results, indicating a favorable safety profile [37] Future Directions 1. **FDA Submission**: GRAIL plans to submit data from the PATHFINDER II study to the FDA by Q1 2026, aiming for Galleri to be the first FDA-approved MCED test [26][27] 2. **NHS-Galleri Study**: A large-scale study in the UK involving 140,000 participants is underway to assess the utility of the Galleri test in a screening population [42][43] 3. **Reimbursement Pathways**: Discussions on alternative reimbursement strategies, including potential use as a surveillance tool for high-risk populations, are ongoing [66] Additional Insights - The importance of building a robust evidence base for the Galleri test was emphasized, with a focus on clinical validation and performance rather than mortality outcomes [57][58] - The potential for Galleri to complement existing single cancer screening tests was highlighted, aiming to improve overall cancer detection rates and reduce healthcare costs associated with false positives [24][25] This summary encapsulates the critical points discussed during the GRAIL Analyst Day, focusing on the company's advancements in cancer detection technology and its strategic direction moving forward.

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $36.2 million, an increase of $7.5 million or 26% compared to Q3 2024 [13] - Screening revenue was $32.8 million, up 29% year-over-year [13] - Net loss for Q3 2025 was $89 million, an improvement of 29% compared to Q3 2024 [14] - Non-GAAP adjusted gross profit for Q3 2025 was $20 million, an increase of $8.2 million or 69% year-over-year [14][15] - Cash and investment position at the end of the quarter was $547.1 million, with approximately $850 million including recent financing [15][16] Business Line Data and Key Metrics Changes - Galleri volumes increased by 39% and revenue by 29% in Q3 2025 [4] - Over 420,000 Galleri commercial tests have been sold since launch, with more than 16,000 healthcare providers involved [4] Market Data and Key Metrics Changes - US Galleri revenue was $32.6 million, up 28% compared to the previous year [14] - The company has introduced Galleri in Canada in partnership with MedCan, expanding its market reach [5] Company Strategy and Development Direction - The company aims to seek FDA approval for Galleri and pursue broad reimbursement [17] - Key milestones include the completion of the PMA submission to the FDA and full clinical utility results from the NHS-Galleri study expected mid-year 2026 [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timeline for FDA submission, now expected in Q1 2026 [20] - The company is focused on cost management, reducing cash burn guidance for 2025 to no more than $290 million, a significant decrease from 2024 [16] Other Important Information - A strategic collaboration with Samsung was announced to commercialize Galleri in South Korea and potentially other Asian markets [4][5] - The company completed a $325 million private placement to strengthen its balance sheet [5] Q&A Session Summary Question: What changed regarding the FDA timeline? - Management indicated increased confidence in the timeline, now set for Q1 2026 instead of the first half of 2026 [20] Question: What incentivized the recent promotion for Galleri? - The promotion reflects significant price elasticity observed, aimed at increasing demand towards year-end [21][22] Question: How will the additional capital from Samsung be used? - The additional capital provides flexibility to enhance commercial investments and fortify areas for scaling the test footprint [25][26] Question: Can you comment on the NHS England decision regarding pilot initiation? - The NHS required exceptional data to initiate a pilot, focusing on metrics like PPV, which was not compelling enough at that time [30][31] Question: What is driving the increase in volumes? - The increase in volumes is attributed to improved provider engagement and the successful integration with companies like Quest and Athenahealth [35][36]

Core Viewpoint - Guggenheim upgraded GRAIL Inc. from Neutral to Buy with a price target of $100, citing strengthened conviction in the company's leading position in multi-cancer early detection testing due to recent clinical data [1] Group 1: Company Position and Product - GRAIL's Galleri test, despite ongoing criticism, is recognized as the most advanced commercial multi-cancer early detection product, supported by extensive prospective data [2] - Analysts noted that while Galleri has imperfections, it maintains a competitive edge and significant total addressable market potential [2] Group 2: Factors Influencing Upgrade - The upgrade was influenced by increased confidence from positive PATHFINDER 2 ESMO data, evolving feedback from key opinion leaders, proprietary analysis indicating a large market opportunity in the U.S. and U.K., and newly secured partnerships to access that market [3] Group 3: Future Outlook - While uncertainties regarding Medicare reimbursement and regulatory approvals for multi-cancer early detection tests persist, GRAIL's early lead and strong clinical foundation position it for significant long-term growth [4]

Core Insights - GRAIL, Inc. reported a 28% year-over-year growth in U.S. Galleri revenue, reaching $32.6 million in Q3 2025, with total revenue increasing by 26% to $36.2 million [2][5] - The company sold over 45,000 Galleri tests in Q3 2025, marking a 39% increase from the previous year [1][3] - GRAIL anticipates submitting its Premarket Approval (PMA) application for Galleri to the FDA in Q1 2026 [3] Financial Performance - Total revenue for Q3 2025 was $36.2 million, up from $28.7 million in Q3 2024, reflecting a 26% increase [2][5] - U.S. Galleri revenue specifically grew by 28% year-over-year to $32.6 million [2][5] - The net loss for the quarter was $89.0 million, an improvement of 29% compared to the previous year [5] - Adjusted gross profit was reported at $20.0 million, a 69% increase year-over-year [5] - Adjusted EBITDA for the quarter was $(71.7) million, showing a 34% improvement from the previous year [5] Business Developments - GRAIL has made significant progress in expanding Galleri's market presence, including a strategic collaboration with Samsung to introduce Galleri in key Asian markets [3][5] - The company has also launched Galleri in Canada and partnered with Medcan to provide access to the test at their clinics [5] - Positive results from the PATHFINDER 2 study were presented, indicating that adding Galleri to standard screenings significantly increased cancer detection rates [5] Cash Position - GRAIL's cash position exceeded $850 million following a recent private placement, providing financial stability into 2030 [5]

Upgrades - JPMorgan upgraded Outfront Media (OUT) to Overweight from Neutral with a price target of $25, up from $19, citing the out-of-home channel as the most resilient traditional advertising market with improved momentum in Q3 [2] - Guggenheim upgraded Grail (GRAL) to Buy from Neutral with a price target of $100, noting that while Galleri is not a perfect test, it remains the leading commercially available MCED test with a significant data moat [3] - Piper Sandler upgraded Floor & Decor (FND) to Overweight from Neutral with a price target of $80, up from $75, highlighting potential for comparable sales improvement by Q1 of 2026 [4] - KeyBanc upgraded Progyny (PGNY) to Overweight from Sector Weight with a price target of $30, indicating limited share downside and several positive catalysts over the next 12 months [4] - KeyBanc upgraded AT&T (T) to Overweight from Sector Weight with a price target of $30, attributing the recent share pullback to overblown wireless competition concerns [5] Downgrades - Raymond James downgraded Bath & Body Works (BBWI) to Market Perform from Outperform, stating that the company's growth will be below its long-term potential due to slow improvements in digital capabilities and distribution [6] - Wolfe Research downgraded Intellia Therapeutics (NTLA) to Peer Perform from Outperform, citing safety issues with nexiguran ziclumeran as a hindrance to the bull thesis [6] - Raymond James double downgraded Brighthouse Financial (BHF) to Market Perform from Strong Buy, referencing the announcement of its acquisition deal for $70 per share [6] - Raymond James double downgraded Centerspace (CSR) to Market Perform from Strong Buy, noting that while the portfolio is attractive for potential buyers, the recent rally has closed the valuation gap with multifamily peers [6] - Northland downgraded QuickLogic (QUIK) to Market Perform from Outperform, maintaining a price target of $5.95, after the company reported revenue in line with guidance and uncertainty regarding a $3M contract [6]