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Writer's pictureKirk Hartley

Finding Cancer Very Early: Grail and Illumina Start Another Year with Another Notable Step Forward

One year ago, Illumina announced a stunning goal: find all cancers very early (stage 1 or 2) through use of massive computing power and artificial intelligence to find mutated cells circulating in a small blood sample. The lead backers of the effort are the world leader in gene sequencing (Illumina), Bill Gates and Jeff Bezos (and others). To that end, they created a new company with a fitting name: Grail. Last year’s news caused me to ask, rhetorically, if people felt the earth move.

Yesterday, a year later, the progress is strong enough they announced yesterday that Grail is to receive $1+ billion in a private placement. That level of investment puts Grail up in the ranks with Uber. The January 5, 2017 press release is online here, and pasted below. A Forbes article is here.

Because I bleed a bit of Illini orange and blue after growing up there and going to the U of I for undergrad, I’ll toss in a friendly reminder the CEO of Grail is a University of Illinois computer science grad who led the teams that created Google Maps and Google Earth. He is Jeff Huber. He is especially highly motivated because his wife died in her 40s because of a colon cancer no one saw coming. He spoke this past spring to the graduating class at the U of I, and had a simple but powerful theme: Find a Better Way. Who would want to bet against him and the rest of the team?

Now imagine the consequences for tort litigation if in fact the Grail team meets its goals.  Among other goals, they seek to have the test approved and on the market in 2019. Clinical trials are to begin this year, and are to scale up to massive numbers. Imagine the possible consequences for litigation when there is a relatively simple to administer screening test to find any cancer at stage 2 or 1, for (they hope) less than $2,000.

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“Illumina, Inc. has issued a new press release.

Title: GRAIL Plans to Raise in Excess of $1B in Series B Funding

Date(s): 5-Jan-2017 4:05 PM

For a complete listing of our news releases, please click here

Investment by Strategic Industry Partners Would Enable GRAIL to Expand Clinical Validation of Blood Test for Early-Stage Cancer Detection

SAN DIEGO–(BUSINESS WIRE)–Jan. 5, 2017– Illumina, Inc. (NASDAQ: ILMN), today announced that GRAIL has received indications of interest to invest approximately $1B for its Series B financing, primarily from undisclosed private and strategic investors. GRAIL intends to raise additional capital in the Series B financing from other investors and has engaged Goldman Sachs as a placement agent in connection with the contemplated additional financing. GRAIL intends to close the Series B prior to the end of the first quarter.

GRAIL will use the proceeds for continued development and validation of their blood-based test for cancer screening, which will require large-scale clinical trials including the previously announced Circulating Cell-free Genome Atlas study as well as other trials that are expected to sequence hundreds of thousands of patients. Additionally, proceeds will be used to repurchase a portion of Illumina’s stake.

“We founded GRAIL a year ago to enable early cancer detection via a blood-based screening test powered by Illumina sequencing technology,” said Jay Flatley, Executive Chairman of Illumina and current Chairman of GRAIL. “This raise, when completed, will provide GRAIL the resources to develop its first products and embark on the large-scale trials required to demonstrate the stringent performance requirements of a cancer screening test.”

Given the potential success of the Series B, and GRAIL’s plan to aggressively invest that capital, Illumina has decided to accelerate their path to independence, which will result in GRAIL becoming one of Illumina’s largest customers over time. Illumina will modify the supply and commercialization agreement with GRAIL to a market-based agreement and will no longer have representation on the Grail Board of Directors. As part of this transaction Illumina’s ownership will become slightly less than 20 percent and GRAIL will be treated as a cost-method investment.

“We are very excited about the progress the GRAIL team has made in the last year,” said Francis deSouza, President and Chief Executive Officer of Illumina. “This capital allows GRAIL to take on the significant technology, market, and regulatory challenges of developing and validating a blood-based cancer screening test. This outcome maximizes value to Illumina by creating one of our largest customers of sequencing instruments and consumables over time, providing royalties on future GRAIL tests and through appreciation of our ownership interest.”

GRAIL’s Chief Executive Officer, Jeff Huber, added, “We are honored to have world-class investors who support our goal of reducing global cancer mortality through early detection — especially the invaluable support we received from Illumina during our start-up phase – and we look forward to the next phase of our growth.”

About Illumina, Inc.

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

About GRAIL

GRAIL is a life sciences company whose mission is to detect cancer early when it can be cured. GRAIL combines the power of high-intensity sequencing (ultra-broad and ultra-deep sequencing), leading-edge computer science, and large population-scale clinical studies to enhance the scientific understanding of cancer biology and develop a blood test for early-stage cancer detection. The company has secured over $100 million in Series A financing from Illumina, Inc. and ARCH Venture Partners, with participating investors including Bezos Expeditions, Bill Gates, Sutter Hill Ventures, and GV (formerly Google Ventures). For more information, please visit www.grail.com.

Forward-Looking Statements

This release contains forward-looking statements that involve risks and uncertainties. Examples of forward-looking statements include, but are not limited to, statements we make regarding the expected availability dates for new products and services and FDA submission dates and intentions for certain products and services. Important factors that could cause actual results to differ materially from those in any forward-looking statements include the risk that GRAIL is not able to raise the amounts contemplated in is its Series B financing to reduce Illumina’s ownership stake below 20% and achieve the planned deconsolidation of GRAIL’s financial results in Illumina’s financials statements, challenges inherent in developing, manufacturing, and launching new products and services, and the other factors that are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170105006393/en/

Source: Illumina, Inc.

Illumina, Inc. Investors: Rebecca Chambers, 858-255-5243 rchambers@illumina.com or Media: Eric Endicott, 858-882-6822 pr@illumina.com” 

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