David Halbert, Caris Life Sciences CEO (Caris via Twitter)

The grow­ing liq­uid biop­sy field sees a uni­corn en­trant as Caris pulls in $830M megaround

Caris Life Sci­ences has pulled in an­oth­er mas­sive raise, and this time they’re re­port­ed­ly one step clos­er to launch­ing their IPO.

The AI-fo­cused Caris pulled in an $830 mil­lion growth eq­ui­ty round, the com­pa­ny an­nounced Tues­day af­ter­noon, earn­ing a val­u­a­tion of about $7.83 bil­lion. Tues­day’s raise al­so brings their to­tal fi­nanc­ing amount to $1.3 bil­lion since 2018 and $1.14 bil­lion since last Oc­to­ber. Ac­cord­ing to the Wall Street Jour­nal, which first re­port­ed on the raise, Caris ex­pects to com­plete their IPO some­time with­in the next 12 months.

Caris’ strat­e­gy uti­lizes ar­ti­fi­cial in­tel­li­gence to map a can­cer pa­tient’s ge­net­ic make­up and de­ter­mine which kinds of treat­ments would be best suit­ed for an op­ti­mal out­come. The com­pa­ny says their plat­form al­lows doc­tors to as­sess all 22,000 genes in both DNA and RNA to do so, uti­liz­ing whole ex­ome se­quenc­ing, whole tran­scrip­tome se­quenc­ing and pro­tein analy­sis in ad­di­tion to its AI mod­els.

Funds from Tues­day’s raise will al­low Caris to push their ef­forts in­to liq­uid biop­sies, in ad­di­tion to the sol­id tu­mor biop­sy ser­vices they cur­rent­ly pro­vide. One of these new pro­grams comes in the form of a blood-based pan-can­cer test, which Caris hopes can be used to de­tect can­cers in their ear­li­er stages.

“This re­cent raise will help us bring our mar­ket-lead­ing sci­ence and tech­nolo­gies to as many pa­tients as pos­si­ble, ul­ti­mate­ly rein­vent­ing can­cer care,” CEO David Hal­bert said in a state­ment. “We plan to un­lock the full po­ten­tial of pre­ci­sion med­i­cine through com­pre­hen­sive in­ter­ro­ga­tion of can­cer at the mol­e­c­u­lar lev­el.”

Pre­ci­sion med­i­cine — and all the tools that make it pos­si­ble — is a high-fly­ing area of the bio­phar­ma in­dus­try, ev­i­denced by Caris’ own fi­nanc­ing and uni­corn val­u­a­tion. One of its main com­peti­tors in ge­nom­ic pro­fil­ing is Foun­da­tion Med­i­cine, which was ac­quired by Roche for $2.4 bil­lion back in 2018. The buy­out had fol­lowed a sim­i­lar $1.9 bil­lion deal where Roche pur­chased Flat­iron Health and their health records sys­tem.

Mean­while, Caris’ move in­to the liq­uid biop­sy are­na will see it join a rel­a­tive­ly new but crowd­ed field, pit­ting it against well-known play­ers like Guardant Health and Third Rock-backed Thrive Ear­li­er De­tec­tion. There’s al­so the Il­lu­mi­na spin-out Grail, which notched its own hefty raise in May 2020 with $390 mil­lion in new fi­nanc­ing and sub­se­quent­ly planned an IPO.

Be­fore it could go pub­lic, how­ev­er, Il­lu­mi­na an­nounced it would be re-ac­quir­ing Grail last Sep­tem­ber for $8 bil­lion. That merg­er was put on hold ear­li­er this year af­ter the FTC moved to block the deal from go­ing through.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another week, another horde of biotechs is doing the Nasdaq dance.

This week saw four companies file their SEC paperwork ahead of expected debuts, another hit Nasdaq on Friday and a sixth formally withdrew its bid to go public. Aerovate Therapeutics, Ocean Biomedical and Acumen Pharmaceuticals all penciled in initial raises of $100 million, while Dermata Therapeutics is estimating a modest $18 million raise.

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Keiichi Fukuda, Heartseed CEO

Fresh off $598M deal with No­vo Nordisk, a Japan­ese stem cell com­pa­ny is on its way to the clin­ic with a dif­fer­ent ap­proach to treat­ing heart fail­ure

A common approach to treating heart failure with induced pluripotent stem cells involves grafting sheets of cells onto the surface of the heart to improve vascularization and blood flow. It’s the easiest method of transplantation — but you run the risk of not making an electrical connection with the heart and the cells not synchronizing with the patient’s heart muscle.

So what if you could inject spherical clusters of heart cells directly into the heart muscle wall? For Heartseed, that’s now the $37 million question.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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