Hans Bishop, Grail CEO (Victor J. Blue/Bloomberg via Getty Images)

$1.6 bil­lion liq­uid biop­sy play­er Grail files IPO, re­veal­ing 2021 com­mer­cial plans and a Mi­das-sized $65M pay pack­age for Hans Bish­op

The hunt for the Grail just got a lot eas­i­er. In fact, in a few weeks you’ll like­ly be able to pick up a por­tion of it on Robin Hood, no co­conut hors­es re­quired.

Grail, the mon­strous­ly backed liq­uid biop­sy biotech, has filed for an IPO. No pric­ing de­tails have been dis­closed, but if his­to­ry is any in­di­ca­tor, the com­pa­ny will have a chance to cap 6 months of boom­ing pan­dem­ic-era of­fer­ings the way the bil­lion-dol­lar Dark Knight films would cap the sum­mer block­buster in their hey­day. CEO Hans Bish­op has pen­ciled in $100 mil­lion for the raise, but that fig­ure has be­come a stan­dard place­hold­er un­til biotechs can gauge ex­act­ly how much they can raise.

The S-1 lifts a lid on a group that has op­er­at­ed in rel­a­tive ob­scu­ri­ty over the past few years, known pri­mar­i­ly by way of the big-name in­vestors — Jeff Be­zos, Il­lu­mi­na and ARCH Ven­ture among them — who poured in $1.6 bil­lion while it was still a pri­vate com­pa­ny. It shows, for one, that the com­pa­ny is plan­ning a faster roll­out than some may have ex­pect­ed. And it re­veals that Bish­op, long one of the in­dus­try’s high­est paid ex­ec­u­tives, got a prince­ly sum to re­turn from a post-Juno sab­bat­i­cal.

Like Third Rock-backed Thrive and a few less­er-known ri­vals, Grail is try­ing to de­vel­op a blood test that can de­tect can­cers more cheap­ly and ear­li­er than con­ven­tion­al di­ag­nos­tics can. It’s a goal that could trans­form can­cer treat­ment, al­low­ing doc­tors to be­gin ther­a­py when it’s most ef­fec­tive and catch po­ten­tial­ly fa­tal ma­lig­nan­cies while they’re still treat­able, but it comes with ma­jor tech­no­log­i­cal and fi­nan­cial hur­dles.

To­day Grail re­vealed plans to roll out its first ma­jor test, called Gal­leri, next year, set­ting them up to po­ten­tial­ly beat Thrive to mar­ket. That promise, the com­pa­ny ac­knowl­edges, comes in ad­vance of the ac­tu­al da­ta to sup­port that test and the roll­out could be de­layed if Covid-19 again blocks tri­als, as they did ear­li­er this year. Grail is cur­rent­ly run­ning a tri­al, called Pathfind­er, to see whether the test can prospec­tive­ly help doc­tors de­tect can­cer ear­ly. They will al­so use a sub­set of da­ta an ob­ser­va­tion­al study that pro­vid­ed their first val­i­da­tion last year.

The com­pa­ny al­so plans to roll out a sec­ond test that will aid tra­di­tion­al di­ag­noses in the sec­ond half of next year. Sub­se­quent tri­al da­ta could help ex­pand the in­di­ca­tion.

To over­see fi­nal de­vel­op­ment and launch, Grail hired Bish­op as CEO last year. The se­r­i­al ex­ec­u­tive had worked with ARCH’s Bob Nelsen at Juno Ther­a­peu­tics, the CAR-T com­pa­ny that Cel­gene bought for $9 bil­lion. Bish­op, who at one point made $88 mil­lion in a year at Juno, took home a pay pack­age of $64 mil­lion last year, most of it in stock.

For an in­tra-in­dus­try com­par­i­son, that’s a lit­tle more than the $59 mil­lion Mod­er­na CEO Stephané Ban­cel earned af­ter the mR­NA biotech’s IPO and it’s a lit­tle less than the $70 mil­lion Sarep­ta’s Doug In­gram made, a fig­ure that ranked him 10th in Bloomberg‘s list of top ten CEOs.

Still, the S-1 al­so points to the ob­sta­cles will face as it looks to tran­si­tion from a cash-rais­ing com­pa­ny to a prof­it-gen­er­at­ing one. No­tably, they will have to se­cure re­im­burse­ment from in­sur­ers, par­tic­u­lar­ly in Med­ic­aid, and they ac­knowl­edge they will prob­a­bly “not have broad-based cov­er­age and re­im­burse­ment at the ini­tial com­mer­cial launch for Gal­leri.” Long-term, if pa­tients have to pay out-of-pock­et, doc­tors may be un­will­ing to or­der it.

They ac­knowl­edge, too, that if “com­peti­tors’ prod­ucts do not per­form as in­tend­ed, the mar­ket for our prod­ucts could be im­paired” — i.e., if an­oth­er com­pa­ny has faulty tests, pay­ers and doc­tors may dis­count the en­tire ap­proach. Which means that, al­though Grail may be rac­ing Thrive and a hand­ful of oth­ers to the fin­ish line, they’re al­so de­pend­ing on them to de­liv­er.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.