George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scan­gos went back to Wall Street, and came back 700 mil­lion pen­nies short.

Scan­gos’ vaunt­ed start­up Vir Biotech­nol­o­gy raised $143 mil­lion in an IPO they hoped would earn $150 mil­lion. Shares were priced at $20, the low-end of the $20-$22 tar­get.

Launched with back­ing from ARCH Ven­ture’s Robert Nelsen, Masayoshi Son’s Soft­Bank Vi­sion Fund, and the Bill & Melin­da Gates Foun­da­tion, the in­fec­tious dis­ease start­up was one of a new wave of well-re­sourced biotechs that emerged with deep enough cof­fers to pur­sue a full R&D line rather than slow­ly build their case by pick­ing off a sin­gle lead pro­gram.

By the time they were a year old, they had bagged $500 mil­lion in fi­nanc­ing and four aca­d­e­m­ic part­ner­ships,  agreed to two sep­a­rate deals worth more than $1 bil­lion apiece in po­ten­tial mile­stones, and land­ed a promi­nent ex-Bio­gen chief in Scan­gos as CEO.  They had lofty goals to match, aim­ing at such mar­quee and elu­sive dis­eases as HIV and hep B and tout­ing a feel-good “glob­al” busi­ness mod­el by which they would sell their drugs in coun­tries that could pay and let the Gates Foun­da­tion dis­trib­ute them in coun­tries that couldn’t.

The IPO promised in­vestors a peek in­to the de­tails and progress on those deals, while giv­ing Vir cash to fu­el their clin­i­cal tri­als.

Ev­i­dent­ly, the in­vestors were slight­ly un­der­whelmed.

The S-1 shows Vir had burned through $256 mil­lion and had $356.5 mil­lion on hand as of June. Pro­ceeds from the IPO are in­tend­ed to fund ear­ly tri­als for hep B can­di­dates VIR-2218 and VIR-3434, along with the flu vac­cine VIR-2482.  Fil­ings al­so showed their R&D deal with Al­ny­lam — ini­tial­ly an­nounced un­der its $1 bil­lion-plus max­i­mum pay­out — was worth on­ly $10 mil­lion up­front.

Be­fore the of­fer­ing, Nelsen owned the biggest chunk of the biotech at 27%, fol­lowed by the Soft­Bank Vi­sion Fund at 21%. Vir’s haul adds an­oth­er IPO dis­ap­point­ment for Soft­Bank, al­though it’s a gen­tle one com­pared to the CEO-top­pling We­Work quake. Vir is one of eight biotechs Soft­Bank is in­vest­ed in, in­clud­ing Vivek Ra­maswamy’s Roivant.

Scan­gos came to the com­pa­ny with a high-pro­file but less-than-flaw­less record. Al­though he helped make Tec­fidera a mul­ti­ple scle­ro­sis block­buster at Bio­gen, he left the com­pa­ny in 2016 with a thin pipeline.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Or­biMed, bio­phar­ma's biggest in­vestor, clos­es $3.5B in three new pri­vate funds

One of the world’s leading biopharma investors has pulled in its next rounds of cash, with the funds planned to go to dozens of companies around the world.

OrbiMed raised $3.5 billion across three private investment funds, it announced Monday, as it continues building on its long track record in healthcare and biopharma. All in all, the firm expects to invest in at least 60 companies across the US, Asia and Europe.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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