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Early Cancer Detection Firm Grail Files for IPO

NEW YORK — Grail, a developer of early cancer detection technologies, on Wednesday filed with the US Securities and Exchange Commission to go public on the Nasdaq.

The Menlo Park, California-based company did not specify the number of shares it intends to float or a price range for the proposed initial public offering. Morgan Stanley, Goldman Sachs, and BofA Securities will act as lead bookrunners of the offering.

Grail is developing a blood-based test, called Galleri, that uses a targeted methylation sequencing panel to detect more than 50 cancer types across all stage and pinpoint a cancer's tissue of origin. Clinical data on the test was published earlier this year in the Annals of Oncology. Grail is also working on a diagnostic aid for cancer test, or DAC, designed to provide a fast diagnostic result for patients suspected of having cancer.

According to its SEC filing, the firm plans to launch Galleri in 2021 as a laboratory-developed test for use in asymptomatic people over 50 years of age, with a premarket approval application for a next-generation version of the test slated for submission as early as 2023. DAC, meanwhile, is expected to launch as an LDT in the second half of next year. Grail also intends to study DAC in individuals with concerning nonspecific symptoms who are not indicated for a cancer workup in order to expand the market for the test, it said in the filing.

Earlier-stage products in Grail's pipeline include blood-based tests for minimal residual disease and cancer recurrence monitoring.

In the SEC filing, Grail noted that it has not generated any revenues to date. It incurred a net loss of $244.9 million in 2019, with last year's R&D spending totaling $158.9 million and G&A expenses $80.9 million.

Since it was founded within Illumina in 2015, Grail has raised over $1.9 billion through venture capital and from strategic partners, including $390 million in Series D funding in May of this year. The company had cash, cash equivalents, and marketable securities totaling $685.6 million as of June 30.

Grail said that proceeds of the planned IPO will be used to fund clinical studies of Galleri and DAC, advance other product candidates, expand its laboratory operations and sales force, and for working capital and general corporate purposes.

The company is led by CEO Hans Bishop, who joined the company in June 2019 and previously founded and served as president and CEO of Juno Therapeutics. Its chief commercial officer is Gautam Kollu, former VP of global market development at Illumina.