Saurabh Saha at Endpoints News' #BIO19

On the heels of $250M launch, Centes­sa barges ahead with an IPO to fu­el its 10-in-1 Medicxi pipeline

Francesco De Ru­ber­tis made no se­cret of IPO plans for Centes­sa, his 10-in-1 lega­cy play. Bare­ly two months lat­er, the S-1 is in.

Francesco De Ru­ber­tis

The hot-off-the-press fil­ing de­picts the same grand vi­sion that the long­time VC tout­ed when he did the rounds in Feb­ru­ary: Take the as­set-cen­tric mind­set that he’s been preach­ing at Medicxi over the years, and roll up a bunch of biotech up­starts, with un­re­lat­ed risk pro­files, in­to 1 phar­ma com­pa­ny that can car­ry on the de­vel­op­ment at scale.

They will be do­ing it with­out Mon­cef Slaoui, who was fea­tured promi­nent­ly in the ini­tial press re­lease as chief sci­en­tif­ic of­fi­cer and ad­vi­sor. Eject­ed from a promi­nent Glax­o­SmithK­line-af­fil­i­at­ed board seat and all biotech po­si­tions fol­low­ing a “sub­stan­ti­at­ed” case of sex­u­al ha­rass­ment (for which he apol­o­gized), the re­tired Op­er­a­tion Warp Speed chief was nowhere to be seen in the S-1.

Mon­cef Slaoui (AP)

In the doc­u­ment, Centes­sa — helmed by Saurabh Sa­ha, the for­mer glob­al head of trans­la­tion­al re­search at Bris­tol My­ers Squibb — spelled out the nit­ty grit­ty de­tails of fit­ting all the puz­zle pieces to­geth­er. As it turned out, it took 11 Medicxi sub­sidiaries to make Centes­sa (in­clud­ing 2 that even­tu­al­ly merged), and the man­age­ment teams at each one were promised their own in­cen­tiviza­tion arrange­ments for stay­ing on to steer the fleet.

The ini­tial ask for the Nas­daq de­but is $100 mil­lion, but giv­en the $250 mil­lion Se­ries A, you can al­most be cer­tain they’re eye­ing a much larg­er fig­ure than the in­creas­ing­ly un­re­li­able place­hold­er.

Not that Centes­sa is strapped for cash. Of­fi­cial­ly formed last Oc­to­ber, it’s on­ly burned through $3.1 mil­lion by the end of 2020. The deep-pock­et­ed in­vestor syn­di­cate fea­tures Gen­er­al At­lantic, Vi­da Ven­tures, Janus Hen­der­son In­vestors, Box­er Cap­i­tal, Cor­morant As­set Man­age­ment, T. Rowe Price, Ven­rock Health­care Cap­i­tal Part­ners, Welling­ton Man­age­ment Com­pa­ny, BVF Part­ners, EcoR1 Cap­i­tal, Franklin Tem­ple­ton, Lo­gos Cap­i­tal, Sam­sara Bio­Cap­i­tal and LifeSci Ven­ture Part­ners.

So why the rush? The com­pa­ny’s IPO dis­clo­sure sug­gests it was a key part of De Ru­ber­tis’ pitch to the biotech en­tre­pre­neurs as he con­vinced them to come on board.

Di­rect in­cen­tiviza­tion is achieved through two prin­ci­ple fi­nan­cial in­cen­tives: first, through each founder-sub­ject mat­ter ex­pert hav­ing a sig­nif­i­cant eq­ui­ty stake in Centes­sa and, there­by, com­pen­sat­ed com­men­su­rate­ly with the Com­pa­ny’s per­for­mance; sec­ond, they dis­pro­por­tion­ate­ly share in up­side through cer­tain agreed mile­stones pay­ment of a pre-agreed amount payable up­on de­fined events such as reg­u­la­to­ry ap­proval of an ap­plic­a­ble drug or the pay­ment of a pre-agreed per­cent­age of the net ag­gre­gate cash pro­ceeds from cer­tain strate­gic trans­ac­tions (in­clud­ing part­ner­ships / out-li­cens­ing agree­ments and/or a sale) con­cern­ing the rel­e­vant Centes­sa Sub­sidiary.

In to­tal, the mile­stone pay­ment for a giv­en sub­sidiary can add up to some­where in the “low eight fig­ure range,” to be di­vid­ed among the top ex­ecs and em­ploy­ees.

They in­clude In­ex­ia, a 3-year-old biotech whose as­sets were trans­ferred ear­li­er this year to Orex­ia, which was sim­i­lar­ly fo­cused on nar­colep­sy and now boasts of both oral and in­tranasal orex­in re­cep­tor ag­o­nists to di­rect­ly ad­dress the un­der­ly­ing pathol­o­gy of orex­in neu­ron loss, as well as oth­er neu­ro­log­i­cal dis­or­ders char­ac­ter­ized by ex­ces­sive day­time sleepi­ness.

Of the 16 pro­grams now in the Centes­sa pipeline, the four clin­i­cal-stage as­sets will re­ceive the largest chunk of cash from the IPO raise. That means fund­ing two Phase III stud­ies for Pal­la­dio’s kid­ney drug lix­i­vap­tan, Apcin­teX’s Ser­pin­PC for he­mo­phil­ia, Pe­gaOne’s an­ti-EGFR im­gatuzum­ab and Z Fac­tor’s ZF874 for al­pha-1-an­tit­rypsin de­fi­cien­cy.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.