Boom­ing Mod­er­na is rais­ing $600M while ramp­ing up man­u­fac­tur­ing and clin­i­cal stud­ies

Ever since Flag­ship launched Mod­er­na back in 2012 with a $40 mil­lion round, the biotech has been a per­pet­u­al mon­ey-rais­ing ma­chine, gar­ner­ing well over a bil­lion dol­lars from an avid group of in­vestors and part­ners look­ing to par­tic­i­pate in its promised drug R&D rev­o­lu­tion. And now in a fil­ing with the SEC, the com­pa­ny has out­lined its lat­est big ef­fort to add $600 mil­lion to its cof­fers, with most of the cash al­ready in hand.

Stephane Ban­cel, Mod­er­na CEO

Ac­cord­ing to the fil­ing, Mod­er­na has raised $451,369,079, with $148,630,019 to go. The Form D was filed last week. The mon­ey marks a new record for Mod­er­na, which raised a $500 mil­lion round (in­clud­ing a sec­ond close) in ear­ly 2015. And As­traZeneca’s Pas­cal So­ri­ot helped get that all start­ed with a whop­ping $240 mil­lion up­front in its 2013 deal, which was tied to $180 mil­lion in mile­stones.

The com­pa­ny de­clined com­ment Mon­day morn­ing.

Mod­er­na CEO Stephane Ban­cel has been build­ing this mes­sen­ger RNA com­pa­ny with a rad­i­cal­ly dif­fer­ent ap­proach to the norm in biotech. In­stead of grab­bing one or two new drugs and set­ting out to gath­er proof-of-con­cept da­ta to help es­tab­lish its sci­en­tif­ic cred­i­bil­i­ty, the com­pa­ny has har­vest­ed a huge wind­fall of cash and built a large or­ga­ni­za­tion be­fore even en­ter­ing the clin­ic. And it did that with­out turn­ing to an IPO.

They don’t get much more rev­o­lu­tion­ary than Mod­er­na, a pri­vate com­pa­ny which be­lieves its mR­NA plat­form tech can de­liv­er the nec­es­sary pack­age to spur cells to pro­duce ther­a­peu­tics, es­sen­tial­ly turn­ing bod­ies in­to drug fac­to­ries.

Ban­cel told me ear­li­er in the month that Mod­er­na had raised $1.5 bil­lion, and pre­sum­ably that in­cludes mon­ey cit­ed in this reg­u­la­to­ry fil­ing. As­traZeneca added $140 mil­lion back at the end of Ju­ly, up­ping its stake in the com­pa­ny to 9%  af­ter the part­ners filed a Eu­ro­pean ap­pli­ca­tion to start a Phase I study of AZD8601, an in­ves­ti­ga­tion­al mR­NA-based ther­a­py that en­codes for vas­cu­lar en­dothe­lial growth fac­tor-A (VEGF-A). As­traZeneca orig­i­nal­ly signed on as a part­ner back in 2013, when new CEO Pas­cal So­ri­ot used it to demon­strate the phar­ma gi­ant’s zeal for big, risky and po­ten­tial­ly rev­o­lu­tion­ary sci­ence projects.

The deal with As­traZeneca cov­ers new drugs for car­dio­vas­cu­lar, meta­bol­ic and re­nal dis­eases as well as can­cer.

Mod­er­na on­ly re­cent­ly pushed its first drugs in­to clin­i­cal de­vel­op­ment, and it’s been scout­ing the Boston area for a new man­u­fac­tur­ing site to pro­duce the hun­dreds of drugs it be­lieves it can make with its mR­NA plat­form.

Ban­cel en­joys noth­ing bet­ter than do­ing things in a big way. So it was no sur­prise that his pre­sen­ta­tion at JP Mor­gan in Jan­u­ary at­tract­ed a stand­ing-room-on­ly crowd of on­look­ers. The Mod­er­na CEO spelled out plans to get the first 6 new drugs in the clin­ic by the end of 2016. The first hu­man study was arranged for the in­fec­tious dis­ease drug mR­NA 1440, which be­gan an ear­ly stage study in 2015.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Vlad Coric, Biohaven CEO

Vlad Coric charts course for 'New Bio­haven' with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the “New Biohaven” post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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