Presto! Wall Street ma­gi­cian Vivek Ra­maswamy has an­oth­er in­stant biotech IPO to sell you

A pair of biotechs are look­ing to raise more than $250 mil­lion through IPOs, slip­ping in­to the short queue on the last work­ing day of Q3. One is from a Bermu­da-based ad­ven­tur­er with a knack for shak­ing loose cheap, late-stage as­sets from phar­ma’s R&D shelves and the oth­er is a ven­ture-backed play­er with plans to carve out a share of a block­buster fran­chise.

The first is My­ovant Sci­ences, an­oth­er in­stant-mix biotech from the 30-year-old for­mer hedge fund man­ag­er Vivek Ra­maswamy. This time, the young fi­nancier has con­jured a com­pa­ny with a re­spect­ed sci­en­tist at the helm and for­mer HHS Sec­re­tary Kath­leen Se­be­lius on the board.

Ra­maswamy made waves dur­ing the wan­ing days of the biotech boom last year by grab­bing a failed Alzheimer’s drug from Glax­o­SmithK­line for a song, then rais­ing an eye-pop­ping $315 mil­lion in an IPO Ax­o­vant is us­ing to pay for a re­vised Phase III tri­al, look­ing to cap­i­tal­ize on a sliv­er of pos­i­tive re­sults spied in the clin­ic while trans­form­ing a shelved ther­a­py in­to an overnight for­tune. Ra­maswamy told Forbes that he wants to be­come the Berk­shire Hath­away of biotech. But in­stead of in­vest­ing heav­i­ly in uni­ver­sal­ly known con­sumer prod­ucts, he’s grab­bing risky drug de­vel­op­ment pro­grams and look­ing for a quick score in Phase III.

In­vestors have been eat­ing it up, so far. And Ra­maswamy now has a $172.5 mil­lion IPO feast planned for My­ovant, which was whipped up last June.

My­ovant’s as­sets are com­ing from Take­da, which is un­der­go­ing a top-to-bot­tom R&D over­haul that shook out re­l­u­golix. Picked up at the end of Phase II, My­ovant is look­ing for cash to pay for a Phase III ef­fort that in­cludes a trio of late-stage stud­ies for uter­ine fi­broids, en­dometrio­sis-as­so­ci­at­ed pain and prostate can­cer. Its sec­ond drug is RVT-602, an oligopep­tide kisspeptin ana­log for the treat­ment of fe­male in­fer­til­i­ty.

Ra­maswamy had to pay GSK $5 mil­lion for its Alzheimer’s drug, lunch mon­ey in the bio­phar­ma world, but the S-1 re­veals that he didn’t need cash for the Take­da drug. Ac­cord­ing to the S-1, Take­da ac­cept­ed about $7.7 mil­lion worth of stock and a war­rant – val­ued at $5.3 mil­lion – that guar­an­tees the Japan­ese com­pa­ny a 12% eq­ui­ty stake in the com­pa­ny for a lim­it­ed amount of time.

Take­da, mean­while, is run­ning a pair of its own Phase III tri­als for re­l­u­golix, which it plans to use for a mar­ket­ing ap­pli­ca­tion in Japan. And My­ovant has the right to use Take­da’s da­ta in its own NDA in the U.S.

Not a drug de­vel­op­er, Ra­maswamy re­cruit­ed Lynn Seely from Medi­va­tion to run the start-up show, which now in­cludes a to­tal of 9 staffers work­ing un­der Ra­maswamy’s um­brel­la group. Seely, the for­mer CMO at Medi­va­tion, has plen­ty of mar­ket cred­i­bil­i­ty as a de­vel­op­er, as Pfiz­er’s $14 bil­lion takeover of Medi­va­tion in Au­gust helped prove.

Like Take­da, Seely was al­so wooed with stock. Seely picked up 2 mil­lion shares (2.6% of the com­pa­ny) when she start­ed and is in line for an­oth­er mil­lion shares in a year, which all vest over time. Se­be­lius’s board po­si­tion should al­so add some heft to the com­pa­ny’s rep.

Ra­maswamy’s record Ax­o­vant IPO was com­plet­ed at the tail end of the go-go pe­ri­od for biotech stocks, but he’ll have to con­tend with a dif­fer­ent mar­ket now, with gen­er­al­ists on the side­lines and in­sid­ers ex­pect­ed to do much of the pur­chas­ing. Some re­cent IPOs have been do­ing well, though, which per­haps in­di­cates that Ra­maswamy’s tim­ing is still good.

Cam­bridge, MA-based Ra Phar­ma­ceu­ti­cals, which has a big block­buster in its sights, is fac­ing the same sit­u­a­tion. The folks at Ra sim­ply be­lieve that they have a bet­ter pep­tide chem­istry plat­form to make a new and im­proved C5 in­hibitor that will prove safer and more ef­fec­tive than Soliris, the most ex­pen­sive ther­a­py in the U.S., which is mar­ket­ed by Alex­ion. And they’re us­ing that ar­gu­ment in an IPO that pen­cils in an $86 mil­lion haul in the S-1.

Like Soliris, their drug is be­ing de­vel­oped for the rare blood dis­or­der parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, or PNH. And the biotech plans to use that lead pro­gram, now poised at the thresh­old of Phase II, to break a path for a pipeline of drugs that ad­dress ail­ments as­so­ci­at­ed with dys­func­tion of the com­ple­ment sys­tem com­po­nent of the im­mune sys­tem. That’s a rich ar­ray of tar­gets, rang­ing from CNS dis­eases to rare blood, neu­ro­log­ic, oph­thal­mo­log­ic, re­nal and in­flam­ma­to­ry con­di­tions.

RA Cap­i­tal Man­age­ment, No­vo Ven­tures, and Light­stone Ven­tures led a $58.5 mil­lion crossover round last sum­mer, jump­ing in­to a syn­di­cate that in­clud­ed new in­vestors Rock Springs Cap­i­tal and Limu­lus Ven­ture Part­ners. A pro­lif­ic New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, Mor­gen­thaler Ven­tures and Am­gen Ven­tures fund­ed the start­up, which says it has enough mon­ey to get through the first half of 2017 with­out new fund­ing.

Ra Phar­ma and My­ovant are both lin­ing IPOs up along­side CRISPR Ther­a­peu­tics, a gene edit­ing com­pa­ny which hopes to see some of the same mar­ket suc­cess ex­pe­ri­enced by Ed­i­tas and In­tel­lia.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

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

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.