GRAIL (GRAL) Company Report

GRAIL anticipates completing its modular PMA submission to the FDA for Galleri in Q1 2026, with an expected 12-month review period, potentially leading to approval in 2027.
The company projects its current funding, including a recent $325 million PIPE and a potential $110 million from Samsung, will extend its cash runway into 2030, positioning it beyond anticipated broad U.S. reimbursement and NHS decisions.
GRAIL's Galleri test demonstrated a 0.4% false positive rate and a 62% positive predictive value in Pathfinder 2, which are significantly better than competitors' tests, providing a key safety and performance advantage.
GRAIL expects Medicare coverage for FDA-approved multi-cancer early detection (MCED) tests to begin phasing in by 2028, contingent on the passage of MCED legislation.
The company's lab is capable of running one million samples today and can scale to 6-10 million samples, with adjusted gross margins reaching 55% in Q3 due to volume leverage, aiming for 50%-60% even at lower price points.

2 days ago

Transcript

Grail Provides Updates on FDA Submission, Clinical Performance, and Financial Outlook

GRAL

Guidance Update

New Projects/Investments

Product Launch

Grail anticipates completing its modular PMA submission to the FDA in Q1 2026, with an estimated 12-month review, potentially leading to reimbursement in 2027. This submission will be one of the largest diagnostic data submissions the FDA has ever seen, involving over 100,000 subjects.
The Galleri test demonstrates a 0.4% false positive rate and a 62% positive predictive value, significantly outperforming competitors. It also increases the cancer detection rate by sevenfold when added to standard care screening and finds over half of cancers in stage one and two.
Currently, 60% of Grail's business is self-pay, with 30%-40% reimbursed by enterprise channels. Broad reimbursement, including Medicare, is contingent on FDA approval and the passage of MCED legislation, with Medicare coverage potentially phasing in by 2028.
Grail recently completed a $325 million PIPE and expects an additional $110 million if the Samsung deal closes, extending its cash runway into 2030. The company's adjusted gross margins increased to 55% in Q3 from 45% in the prior quarter due to volume, with a goal of 50%-60% even at lower ASPs.
Grail has launched Galleri in Israel and Canada, and a strategic collaboration with Samsung is aimed at accelerating expansion into the Asian market.

2 days ago

Transcript

GRAIL Updates on Regulatory Milestones, Financial Position, and Market Expansion

GRAL

New Projects/Investments

Guidance Update

Revenue Acceleration/Inflection

GRAIL anticipates completing its FDA PMA submission in Q1 2026, with a 12-month review period, potentially leading to approval around Q1 2027.
Medicare coverage for the Galleri test is projected to begin approximately one year after FDA approval, contingent on MCED legislation passing, with provisions effective in 2028.
The company recently raised $325 million via a PIPE and anticipates an additional $110 million from a Samsung partnership, extending its cash runway into 2030.
Adjusted gross margins improved to 55% in Q3 from 45% in the prior quarter, with a target of 50%-60% even at lower price points, supported by a scalable lab capable of running 1 million samples today.
Key international data from the 140,000-person NHS-Galleri study is expected in mid-2026, which is crucial for global market access.

2 days ago

Transcript

GRAIL Provides Updates on FDA Submission, Clinical Data, and Reimbursement Pathway

GRAL

New Projects/Investments

Guidance Update

Revenue Acceleration/Inflection

GRAIL anticipates submitting its Galleri Multi Cancer Early Detection Test for FDA approval in Q1 2026, leveraging over 90,000 patient records from studies like Pathfinder 2 and the NHS-Galleri prevalent round.
The company reported strong clinical performance from Pathfinder 2, demonstrating a 7-fold improvement in cancer detection rate when Galleri is added to standard of care screening, a 62% positive predictive value (PPV), and 90% cancer signal origin (CSO) accuracy.
Key milestones for 2026 include the FDA submission in Q1 and the readout of the full NHS-Galleri study's clinical utility endpoint in mid-2026.
Momentum is building for the MSAD bill in Congress, which could enable CMS reimbursement of approximately $500 per test starting in 2028 if passed.
GRAIL has extended its financial runway into 2030, enhancing flexibility and de-risking future uncertainties, while also noting a repeat test rate of over 30% for Galleri.

Nov 18, 2025, 3:00 PM

Transcript

GRAIL provides updates on FDA submission timeline, NHS-Galleri data, and extended financial runway

GRAL

Guidance Update

New Projects/Investments

Regulatory Update

GRAIL plans to submit its PMA to the FDA in Q1 2026, narrowing the previous timeline. The company expresses high confidence due to a large data package, including over 90,000 patient records and strong performance metrics from Pathfinder 2, such as a 7-fold improvement in cancer detection rate when Galleri is added to standard care screening.
The full NHS-Galleri study data, including its clinical utility endpoint (reduction in stage three and four cancers), is expected to read out in mid-2026. This data is crucial for NHS decisions and future US payer discussions, although the FDA submission will only include the prevalent round data.
Momentum for the MSAD bill in Congress is strong, with bipartisan support, and if passed, it could lead to CMS coverage authority starting in 2028 with an estimated reimbursement of ~$500 per test.
GRAIL has extended its financial runway into 2030, providing significant flexibility and de-risking the timing of FDA approval and CMS reimbursement.
Commercial momentum is strong, with the repeat test rate for Galleri now over 30%, up from 20% earlier in the year, which is considered unprecedented for a non-reimbursed, non-FDA approved screening test.

Nov 18, 2025, 3:00 PM

Transcript

GRAIL Narrows FDA Submission Timeline to Q1 2026 and Extends Financial Runway

GRAL

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL plans to submit its Galleri Multi Cancer Early Detection Test for PMA approval to the FDA in the first quarter of 2026. The submission will include over 90,000 patient records, highlighting a seven-fold improvement in cancer detection rate and a 62% positive predictive value (PPV) from Pathfinder 2 data.
The full NHS-Galleri study data, which will assess clinical utility, is anticipated to read out in mid-2026 and will be critical for both NHS decisions and US payer discussions.
There is significant momentum for the MSAD bill in Congress, which could enable Medicare coverage authority by 2028 with an estimated reimbursement of $508 or $509 per test.
GRAIL has extended its financial runway into 2030, enhancing flexibility and mitigating risks associated with regulatory and reimbursement timelines.

Nov 18, 2025, 3:00 PM

Transcript

GRAIL, Inc. Establishes $300 Million At-The-Market Equity Offering

GRAL

Equity Offering

GRAIL, Inc. entered into an Equity Distribution Agreement on November 14, 2025, with Morgan Stanley & Co. LLC and TD Securities (USA) LLC, enabling an "at-the-market" (ATM) offering.
Under this agreement, the company may offer and sell up to an aggregate of $300,000,000 of its common stock, with the total number of shares not exceeding 6,900,000.
The sales agents for the ATM offering will receive a commission of up to 3.0% of the gross sales proceeds from sales made under the agreement.
Separately, on November 13, 2025, the company filed a prospectus supplement for the resale of 3,925,767 shares of common stock by selling securityholders, which includes 1,927,194 issued shares and 1,998,573 shares issuable upon exercise of pre-funded warrants.

Nov 14, 2025, 11:19 AM

8-K

GRAL Provides Financial and Operational Update, Targets Q1 2026 FDA Submission

GRAL

Guidance Update

New Projects/Investments

Revenue Acceleration/Inflection

GRAL reported $125 million in revenue for 2024 and a 25% growth rate through the first nine months of 2025, with an updated cash burn guidance of $290 million for 2025 net of financing fees.
The company's gross margins increased to 55% (likely 2024) from 41% (likely 2023), reflecting improvements from a new platform.
GRAL is targeting Q1 2026 for the completion of its FDA submission for the Galleri MCED test, aiming to be the first FDA-approved test in this category, supported by PATHFINDER II study data showing a 62% positive predictive value and 99.6% specificity.
Market access is expanding through over 150 self-insured employer partnerships and international launches in Israel, Canada, and Asia via a collaboration with Samsung, which includes a $110 million investment in GRAL.

Nov 13, 2025, 4:00 PM

Transcript

GRAIL Reports Q3 2025 Financial Results and Accelerates FDA PMA Submission Timeline

GRAL

Earnings

Guidance Update

New Projects/Investments

GRAIL reported Q3 2025 revenue of $36.2 million, a 26% increase compared to Q3 2024, driven by 39% growth in Galleri volumes and 29% growth in screening revenue. The company also saw an improvement in net loss, which was $89 million, a 29% improvement from Q3 2024.
The company strengthened its balance sheet with a $325 million private placement in October, bringing total cash and investments to approximately $850 million, and Samsung has agreed to a $110 million equity investment. GRAIL updated its full-year 2025 cash burn guidance to no more than $290 million, with a cash runway extending into 2030.
GRAIL announced positive clinical data, including a 61.6% positive predictive value (PPV) and 99.6% specificity from the Pathfinder II study, and an updated PPV of 84.2% for Galleri in symptomatic patients from the SYMPLIFY study.
The timeline for the FDA PMA submission for Galleri has been accelerated to Q1 2026, previously expected in the first half of 2026.

Nov 12, 2025, 9:30 PM

Transcript

GRAIL, Inc. Reports Third Quarter 2025 Financial Results

GRAL

Earnings

New Projects/Investments

Revenue Acceleration/Inflection

GRAIL, Inc. reported total revenue of $36.2 million for the third quarter of 2025, representing a 26% increase year-over-year. Galleri revenue specifically grew 29% year-over-year to $32.8 million, with test volumes increasing 39%.
The company's net loss for Q3 2025 was $89.0 million, an improvement of 29% compared to the same period last year.
GRAIL's cash position, which includes proceeds from a recently completed private placement, is more than $850 million, providing a financial runway into 2030.
The PMA submission for Galleri to the FDA is now anticipated in Q1 2026. Additionally, GRAIL announced a strategic collaboration with Samsung to bring the Galleri test to key Asian markets, which includes a $110 million equity investment from Samsung.

Nov 12, 2025, 9:03 PM

8-K

Earnings Transcripts

Quarterly earnings call transcripts for GRAIL.

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