Mod­er­na boosts uni­corn sta­tus with a whop­ping $500M raise and $7B val­u­a­tion

Stéphane Ban­cel, Mod­er­na CEO

The biotech world’s biggest uni­corn just raised $500 mil­lion, bring­ing its to­tal haul to about $2.5 bil­lion from part­ner­ships and in­vestors while valu­ing the com­pa­ny at close to $7 bil­lion.

This year Mod­er­na will burn through about $450 mil­lion, the ex­ec­u­tive team tells me to­day. And with this new fi­nanc­ing, the com­pa­ny has three years of run­way — plen­ty of time to fig­ure out the right tim­ing for an even­tu­al IPO.

“We al­ways like to have sev­er­al years of cap­i­tal,” says CEO Stéphane Ban­cel. “And we want to keep on ex­pand­ing the in­vestor base.”

They ac­com­plished that goal in style.

Mod­er­na raised the cash from a broad, glob­al syn­di­cate that stretched from the Mid­dle East to Eu­rope and on to Chi­na. The group in­clud­ed the Abu Dhabi In­vest­ment Au­thor­i­ty, BB Biotech AG, Julius Baer, Sin­ga­pore-based ED­BI and Se­quoia Cap­i­tal Chi­na. Ex­ist­ing in­vestors that al­so par­tic­i­pat­ed in this round in­clude Fi­deli­ty Man­age­ment and Re­search, Pictet, Viking Glob­al In­vestors, Ar­row­Mark Part­ners and Alexan­dria Ven­ture In­vest­ments.

With the raise, the com­pa­ny has $1.4 bil­lion in cash in the bank, and an­oth­er $250 mil­lion com­ing from es­tab­lished grants. That trea­sure trove will be used to back a staff that has grown in­to the hun­dreds, with ded­i­cat­ed man­u­fac­tur­ing sup­port and a host of big part­ners work­ing with them on de­vel­op­ment pro­grams.

That leaves every­one ask­ing the same big ques­tion: When will Mod­er­na go pub­lic?

“We’re not pre­pared to go there,” re­spond­ed CFO Lorence Kim when I asked. “With this cap­i­tal we will now look at the ad­vance­ment of our pro­grams through and in the clin­ic” as they pon­der the right next step on fi­nanc­ing.

But it’s cer­tain­ly on the radar. Adds Kim: “We are be­gin­ning the process of prepar­ing and eval­u­at­ing the costs and in­fra­struc­ture of be­ing pub­lic.”

For a pri­vate biotech with deep-pock­et in­vestors back­ing it, Mod­er­na has stirred some pow­er­ful feel­ings — both pro and con — in the Cam­bridge/Boston biotech hub where it’s based.

Noubar Afeyan

Sup­port­ers look at a broad­en­ing pipeline that cur­rent­ly has 19 pro­grams in clin­i­cal de­vel­op­ment for a po­ten­tial­ly break­through ap­proach us­ing mes­sen­ger RNA, as of the most re­cent up­date at JP­Mor­gan. And Noubar Afeyan, the chief at Flag­ship, has made it a prime ex­am­ple of the kind of ma­jor league play­er he wants to bring up from the AAA.

For them, Mod­er­na is part of the new breed of biotechs.

Crit­ics have hit the com­pa­ny for a huge val­u­a­tion that’s ex­tra­or­di­nary for a biotech that has no mar­ket­ed prod­ucts and a pipeline that still has some ma­jor strides to go be­fore get­ting in­to late-stage de­vel­op­ment. For that crowd, the big mon­ey and pay­roll at Mod­er­na are a sign of pure froth in an over­heat­ed mar­ket.

For them, Mod­er­na is an aber­ra­tion that threat­ens to crum­ble.

Love them or hate them, though, Mod­er­na is play­ing for all the mar­bles, and this lat­est $500 mil­lion raise and multi­bil­lion-dol­lar val­u­a­tion speaks to their suc­cess in get­ting some well heeled back­ers to go very deep, and very long, in giv­ing them the funds to go all the way.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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