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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Philip Dormitzer

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,200+ biopharma pros reading Endpoints daily — and it's free.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

FDA can­cels ODAC meet­ing this week to re­view two more dan­gling ac­cel­er­at­ed ap­provals — but won't ex­plain why

The FDA’s Oncologic Drugs Advisory Committee has decided to cancel a planned meeting on Thursday to discuss two cancer drugs that previously won accelerated approvals but failed to confirm clinical benefit in required follow-up trials or have taken a long time to finish those trials.

The FDA said in a statement that the meeting “is no longer needed” but did not offer further detail on why exactly it was canceled, telling Endpoints News to contact the companies. Attempts to contact both Secura Bio and Acrotech went unreturned. The companies may have decided to pull these treatments from the market, or they’ve come to new agreements with the agency on their confirmatory trials.