Henry Ji, Sorrento CEO

Sor­ren­to ousts CFO as long-run­ning Covid-19 dra­ma con­tin­ues

The wild ride at Sor­ren­to keeps charg­ing ahead, though now with one less par­tic­i­pant.

Jiong Shao

CFO Jiong Shao has been un­cer­e­mo­ni­ous­ly boot­ed from the Cal­i­for­nia-based biotech, “ef­fec­tive im­me­di­ate­ly,” ac­cord­ing to a com­pa­ny SEC fil­ing Tues­day. Re­plac­ing him is Na­j­jam As­ghar, Sor­ren­to’s chief ac­count­ing of­fi­cer since June 2019. Shao’s fir­ing took place Mon­day and As­ghar was named his suc­ces­sor Tues­day, the fil­ing said.

News of the ouster caused Sor­ren­to’s stock to slide around 12% in af­ter hours trad­ing. The com­pa­ny’s stock is up over 260% for the year.

As­ghar will earn a salary of $300,000. He came to Sor­ren­to from the med­ical de­vices com­pa­ny Nu­Va­sive, where he worked from 2015 to 2019. Pri­or to that, he spent near­ly a dozen years at pow­er­house ac­count­ing firm Price­wa­ter­house­C­oop­ers.

Sor­ren­to has been in the news fre­quent­ly over the last few months, as it is de­vel­op­ing a mon­o­clon­al an­ti­body that binds to and neu­tral­izes SARS-CoV-2, the virus that caus­es Covid-19. Back in May, the com­pa­ny hyped up the an­ti­body as a po­ten­tial “cure” for the dis­ease de­spite not test­ing the com­pound in an­i­mals or hu­mans, draw­ing heavy crit­i­cism from bioethi­cists.

“We want to em­pha­size there is a cure. There is a so­lu­tion that works 100 per­cent,” CEO Hen­ry Ji told a Fox News re­porter at the time. “If we have the neu­tral­iz­ing an­ti­body in your body, you don’t need the so­cial dis­tanc­ing. You can open up a so­ci­ety with­out fear.”

Those grand state­ments caused Sor­ren­to to briefly triple in val­ue and prompt­ed con­cern from in­vestors that the biotech is putting out flashy state­ments for the sake of keep­ing mon­ey flow­ing. In­de­pen­dent biotech in­vestor Brad Lon­car said at the time Sor­ren­to is “known for hav­ing that rep­u­ta­tion.”

Then in late Ju­ly, the com­pa­ny an­nounced a $5 mil­lion li­cens­ing deal with Co­lum­bia Uni­ver­si­ty for a sali­va-based Covid-19 test, which aims to pro­vide a re­sult with­in 30 min­utes. A pre­lim­i­nary study showed the test has sen­si­tiv­i­ty and speci­fici­ty rates of 97% and 100%, re­spec­tive­ly.

How­ev­er, a few weeks lat­er, in­vest­ment re­search firm Hin­den­burg Re­search re­leased parts of a quote from an anony­mous se­nior Co­lum­bia of­fi­cial call­ing Sor­ren­to’s claims about the test “a com­plete joke.”

“Co­lum­bia wasn’t un­der the as­sump­tion they were get­ting in­volved in a stock pump and dump,” the un­named ad­min­is­tra­tor went on to say. “Why would we sell some­thing for 5 mil­lion and roy­al­ties that has mar­ket po­ten­tial? And it’s be­cause it doesn’t have mar­ket po­ten­tial — every­one in­ter­nal­ly knows that.”

In re­sponse to that de­vel­op­ment, Sor­ren­to an­nounced last Wednes­day it is con­sid­er­ing tak­ing le­gal ac­tion against Hin­den­burg, claim­ing with­out ev­i­dence that the firm is at­tempt­ing to ma­nip­u­late the com­pa­ny’s stock price with “false and/or mis­lead­ing state­ments.” The spit test is­sue was com­pound­ed fol­low­ing the FDA’s emer­gency use au­tho­riza­tion last Fri­day of a com­pet­ing pro­gram at Yale, and it re­mains un­clear if Shao’s ouster is con­nect­ed to that sit­u­a­tion.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

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Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.