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.

Jeff Albers, Blueprint CEO

Di­ag­nos­tic champ Roche buys its way in­to the RET ti­tle fight with Eli Lil­ly, pay­ing $775M in cash to Blue­print

When Roche spelled out its original $1 billion deal — $45 million of that upfront — with Blueprint to discover targeted therapies against immunokinases, the biotech partner’s RET program was still preclinical. Four years later, pralsetinib is on the cusp of potential approval and the Swiss pharma giant is putting in much more to get in on the commercial game.

Roche gains rights to co-develop and co-commercialize the drug, with sole marketing responsibility for places outside the US and China (where CStone has staked its claim).

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Trans­port Sim­u­la­tion Test­ing for Your Ther­a­py is the Best Way to As­sure FDA Ex­pe­dit­ed Pro­gram Ap­proval

Modality Solutions is an ISO:9001-registered biopharmaceutical cold chain engineering firm with unique transport simulation capabilities that support accelerated regulatory approval for biologics and advanced therapeutic medicinal products (ATMP). Our expertise combines traditional validation engineering approaches with regulatory knowledge into a methodology tailored for the life sciences industry. We provide insight and execution for the challenges faced in your cold chain logistics network.

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Who are the women blaz­ing trails in bio­phar­ma R&D and lead­ing the fight against Covid-19? Nom­i­nate them for End­points' spe­cial re­port

One of the many inequalities the pandemic has laid bare is the gender imbalance in biomedical research. A paper examining Covid-19 research authorship wondered out loud: Where are the women?

It’s a question that echoes beyond our current times. In the biopharma world, not only are women under-represented in R&D roles (particularly at higher levels), their achievements and talents could also be undermined by stereotypes and norms of leadership styles. The problem is even more dire for women of color.

Tal Zaks, Moderna CMO (Moderna via YouTube)

UP­DAT­ED: NI­AID and Mod­er­na spell out a 'ro­bust' im­mune re­sponse in PhI coro­n­avirus vac­cine test — but big ques­tions re­main to be an­swered

The NIAID and Moderna have spelled out positive Phase I safety and efficacy data for their Covid-19 vaccine mRNA-1273 — highlighting the first full, clear sketch of evidence that back-to-back jabs at the dose selected for Phase III routinely produced a swarm of antibodies to the virus that exceeded levels seen in convalescent patients — typically in multiples indicating a protective response.

Moderna execs say plainly that this first stage of research produced exactly the kind of efficacy they hoped to see in humans, with a manageable safety profile.

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Mene Pangalos, AstraZeneca R&D chief (AstraZeneca via YouTube)

A day af­ter Mod­er­na vac­cine re­sults, ru­mors swirl of pend­ing As­traZeneca da­ta

A day after Moderna and the NIH published much-anticipated data from their Phase I Covid-19 vaccine trial, attention is turning to AstraZeneca which, according to a UK report, is expected to publish its own early data tomorrow.

ITV’s Robert Peston reported that AstraZeneca will publish the Phase I data in The Lancet. 

AstraZeneca and Moderna represent the two most ambitious Covid-19 vaccine efforts, having set the quickest timelines for approval (though they were recently joined in that regard by the Pfizer-BioNTech partnership) and some of the loftiest goals in total doses. Yet there is even less known about AstraZeneca’s vaccine’s effect on humans than there was about Moderna’s before yesterday. Although, in a controversial move, Moderna released some statistics from its Phase I in May, AstraZeneca has yet to say anything about what it saw in its Phase I trial — a move consistent with the scientific convention to withhold data until it can be published in a peer-reviewed journal.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

‘Plan­ning to vac­ci­nate every­one in the US,’ Mod­er­na out­lines ef­forts to sup­ply their Covid-19 vac­cine as man­u­fac­tur­ing ramps up ahead of PhI­II

Twelve days from the planned start of their Phase III pivotal trial, the executive crew at Moderna has set up the manufacturing base needed to begin production of the first 500,000 doses of their Covid-19 vaccine with plans to feed it into a global supply chain. But the initial batches will likely be ready in the US first, where company CEO Stéphane Bancel plans to be able to vaccinate everyone.

“We have started making commercial product at-risk, and will continue to do so every day and every week of the month,” Bancel told analysts during their morning call on the Phase I data just published in the New England Journal of Medicine.

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Covid-19 roundup: Vac­cine by end of 2020? Ken Fra­zier warns hype do­ing 'grave dis­ser­vice'

When it comes to setting expectations about a Covid-19 vaccine, Ken Frazier does not mince words.

Over a month after first casting doubts on the aggressive 12- to 18-month timeframe championed by the US government and his biopharma peers, the Merck CEO again cautioned against any hype around a quick vaccine approval.

In a wide-ranging interview with Harvard Business School professor Tsedal Neeley that touched other big topics such as race, Frazier emphasized that vaccines take a long time to develop. He would know: Out of the seven new vaccines introduced around the world in the past 25 years, four came from Merck.

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Stéphane Bancel, Moderna CEO (Andrew Harnik/AP Images)

A top an­a­lyst turns the spot­light on Mod­er­na, fu­el­ing a fast-and-fu­ri­ous Street race over the fu­ture of mR­NA

Bioregnum Opinion Column by John Carroll

Four months ago, one of the favorite talking points on the biopharma social media wave length was whether Moderna shares $MRNA were priced right or were wildly inflated.

After all, said the naysayers, the company had never actually pushed a treatment to an approval. Did messenger RNA really work, coding cells to make a drug or a vaccine? And how about all that chatter about how ‘secretive’ they are, or were?

Now, as CEO Stéphane Bancel and the top execs push the company to the forefront of a frantic race to develop the first vaccine to fight against the reignited wildfire spread of Covid-19, all those questions have been magnified — along with the stock price.

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Mil­li­pore­Sig­ma to build new $20 mil­lion, 12,000-square-foot lab in Switzer­land

On the heels of opening a new laboratory in Shanghai last week, MilliporeSigma is continuing its construction push.

The Merck KGgA life science subsidiary announced Wednesday its intentions to build a new $20 million lab in Buchs, Switzerland to support its reference materials business. It’s estimated that the new facility will be completed in December 2021 and open in early 2022 and is expected to be 12,000 square feet.