Fa­heem Has­nain ups cash haul to $330M for a fledg­ling biotech that is mov­ing ‘at light speed’

Just six months ago, Fa­heem Has­nain rolled out his lat­est biotech ven­ture with a $100 mil­lion mega-round for seed mon­ey. To­day, he’s adding $230 mil­lion more for Gos­samer Bio from a glob­al syn­di­cate of heavy­weight in­vestors that is bet­ting big that the ex-Re­cep­tos chief and his team can birth a ma­jor new com­pa­ny vir­tu­al­ly overnight by biotech stan­dards, with a pipeline that al­ready in­cludes 4 drugs, more ther­a­pies com­ing and an em­ploy­ee ros­ter slat­ed to hit 100 by the end of this year.

And yes, there’s an IPO out there some­where along the way, he says, when the stars align.

“We just start­ed in Jan­u­ary,” Has­nain told me over the week­end, “and we’ve been go­ing at light speed.”

Sheila Gu­jrathi

Start­ing with a hand­ful of key play­ers from his Re­cep­tos days, Has­nain’s Gos­samer has al­ready grown to 60 staffers, he adds, with plans to leap to about 100 by the end of the year. Next year he ex­pects the pipeline to swell to 5 to 6 mid-stage pro­grams, each en­sconced in its own sub­sidiary to al­low for one-on-one deal­mak­ing dis­cus­sions, as they might arise.

Has­nain has one of the most im­pres­sive re­sumes in biotech, hav­ing sold Re­cep­tos and its star drug ozan­i­mod — still a block­buster con­tender at Cel­gene, though one held up by a sna­fu with the NDA — for $7.2 bil­lion. And he has one of the best con­nect­ed syn­di­cates in the book ready to back his com­pa­ny-cre­ation plan. 

Chi­na’s in­flu­en­tial Hill­house Cap­i­tal led the round, with help from the Abu Dhabi In­vest­ment Au­thor­i­ty, In­vus, The Bau­post Group and Po­laris Part­ners. Gos­samer Bio’s ex­ist­ing in­vestors, Arch Ven­ture Part­ners and Omega Funds, stepped back up, with Arch’s Bob Nelsen demon­strat­ing once again his ap­petite for go­ing big, fast with oth­er in­vestors who have the same ap­proach.

This is not your typ­i­cal start­up. 

Has­nain joins a se­lect group of play­ers like Arie Bellde­grun or some of the new Chi­na ex­ecs who are by­pass­ing the slow and me­thod­i­cal art of com­pa­ny cre­ation around 1 or 2 key drugs. Backed with hun­dreds of mil­lions of dol­lars, they are look­ing for vir­tu­al overnight suc­cess in cre­at­ing in­flu­en­tial de­vel­op­ment ef­forts. And giv­en the fail­ure rate in drug de­vel­op­ment, they face a daunt­ing task with tough odds.

Bob Nelsen

It’s a new world for high­ly suc­cess­ful teams, though, adding Chi­nese in­vestors to syn­di­cates and go­ing big ear­ly. I asked Has­nain if he could have done some­thing like this 5 years ago.

“Five years ago was when we took Re­cep­tos pub­lic,” says Has­nain. “We were in the ear­ly wave of go­ing pub­lic. So sen­ti­ment is one (dif­fer­ence). Sen­ti­ment is def­i­nite­ly much more op­ti­mistic to­day.”

In­deed it is.

Has­nain is step­ping up to the ex­ec­u­tive chair­man’s spot with the B round, while his long­time col­league Sheila Gu­jrathi takes the CEO’s job. His job now is to do the broad strate­gic think­ing, while al­low­ing Gu­jrathi to move up and open a new chap­ter in her ca­reer.

It’s time, he says.

The two of them have been play­ing the lead role in snap­ping up new drugs for the pipeline. 

“I can’t dis­close all the tar­gets,” says Has­nain, who wants to re­tain some cov­er for the pipeline for a few months longer. “We do have 3 clin­i­cal-stage pro­grams in the com­pa­ny and one pre­clin­i­cal.”

One of those deals is pub­lic. Has­nain and his team in-li­censed a drug called KB-4924 (now GB004) from Aer­pio Phar­ma­ceu­ti­cals. They paid $20 mil­lion in cash and put $400 mil­lion on the ta­ble in mile­stones for an in­ves­ti­ga­tion­al hy­pox­ia-in­ducible fac­tor-1 al­pha (HIF-1 al­pha) sta­bi­liz­er in de­vel­op­ment for IBD.

A few days ago Gos­samer bagged an­oth­er drug for a “large au­toim­mune in­di­ca­tion,” which is en­ter­ing Phase II with “some sub­stan­tial val­i­da­tion around the tar­get” which he thinks gives it the kind of pipeline-in-a-prod­uct po­ten­tial he saw in ozan­i­mod. That one is stay­ing un­der wraps for now.

Has­nain’s plans for this com­pa­ny stretch well past the first $330 mil­lion in. He’s al­ready talk­ing about fil­ing an IPO when the time is right.

“Go­ing pub­lic is def­i­nite­ly in our sights,” he says.


Fa­heem Has­nain. GOS­SAMER BIO

De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Roger Perlmutter, Merck

#ASH19: Here’s why Mer­ck is pay­ing $2.7B to­day to grab Ar­Qule and its next-gen BTK drug, lin­ing up Eli Lil­ly ri­val­ry

Just a few months after making a splash at the European Hematology Association scientific confab with an early snapshot of positive data for their BTK inhibitor ARQ 531, ArQule has won a $2.7 billion buyout deal from Merck.

Merck is scooping up a next-gen BTK drug — which is making a splash at ASH today — from ArQule in an M&A pact set at $20 a share $ARQL. That’s more than twice Friday’s $9.66 close. And Merck R&D chief Roger Perlmutter heralded a deal that nets “multiple clinical-stage oral kinase inhibitors.”

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Game on: Re­gen­eron's BC­MA bis­pe­cif­ic makes clin­i­cal da­ta de­but, kick­ing off mul­ti­ple myelo­ma matchup with Bris­tol-My­ers

As J&J attempts to jostle past Bristol-Myers Squibb and bluebird for a landmark approval of its anti-BCMA CAR-T — and while GlaxoSmithKline maps a quick path to the FDA riding on its own BCMA-targeting antibody-drug conjugates — the bispecifics are arriving on the scene to stake a claim for a market that could cross $10 billion per year.

The main rivalry in multiple myeloma is shaping up to be one between Regeneron and Bristol-Myers, which picked up a bispecific antibody to BCMA through its recently closed $74 billion takeover of Celgene. Both presented promising first-in-human data at the ASH 2019 meeting.

FDA lifts hold on Abeon­a's but­ter­fly dis­ease ther­a­py, paving way for piv­otal study

It’s been a difficult few years for gene and cell therapy startup Abeona Therapeutics. Its newly crowned chief Carsten Thiel was forced out last year following accusations of unspecified “personal misconduct,” and this September, the FDA imposed a clinical hold on its therapy for a form of “butterfly” disease. But things are beginning to perk up. On Monday, the company said the regulator had lifted its hold and the experimental therapy is now set to be evaluated in a late-stage study.

Paul Hudson. Sanofi

New Sanofi CEO Hud­son adds next-gen can­cer drug tech to the R&D quest, buy­ing Syn­thorx for $2.5B

When Paul Hudson lays out his R&D vision for Sanofi tomorrow, he will have a new slate of interleukin therapies and a synthetic biology platform to boast about.

The French pharma giant announced early Monday that it is snagging San Diego biotech Synthorx in a $2.5 billion deal. That marks an affordable bolt-on for Sanofi but a considerable return for Synthorx backers, including Avalon, RA Capital and OrbiMed: At $68 per share, the price represents a 172% premium to Friday’s closing.

Synthorx’s take on alternative IL-2 drugs for both cancer and autoimmune disorders — enabled by a synthetic DNA base pair pioneered by Scripps professor Floyd Romesberg — “fits perfectly” with the kind of innovation that he wants at Sanofi, Hudson said.

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Roche faces an­oth­er de­lay in strug­gle to nav­i­gate Spark deal past reg­u­la­tors — but this one is very short

Roche today issued the latest in a long string of delays of its $4.3 billion buyout of Philadelphia-based Spark Therapeutics. The delay comes as little surprise — it is their 10th in as many months — as their most recent delay was scheduled to expire before a key regulatory deadline.

But it is notable for its length: 6 days.

Previous extensions had moved the goalposts by about 3 weeks to a month, with the latest on November 22 expiring tomorrow. The new delay sets a deadline for next Monday, December 16, the same day by which the UK Competition and Markets Authority has to give its initial ruling on the deal. And they already reportedly have lined up an OK from the FTC staff – although that’s only one level of a multi-step process.

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KalVis­ta's di­a­bet­ic mac­u­lar ede­ma da­ta falls short — will Mer­ck walk away?

Merck’s 2017 bet on KalVista Pharmaceuticals may have soured, after the UK/US-based biotech’s lead drug failed a mid-stage study in patients with diabetic macular edema (DME).

Two doses of the intravitreal injection, KVD001, were tested against a placebo in a 129-patient trial. Patients who continued to experience significant inflammation and diminished visual acuity, despite anti-VEGF therapy, were recruited to the trial. Typically patients with DME — the most frequent cause of vision loss related to diabetes — are treated with anti-VEGF therapies such as Regeneron’s flagship Eylea or Roche’s Avastin and Lucentis.

UP­DAT­ED: Ob­sE­va makes case for best-in-class hor­mone sup­pres­sive ther­a­py in pos­i­tive uter­ine fi­broid study

About a month after the Swiss biotech disclosed a failed late-stage study in its IVF program, ObsEva on Monday unveiled positive pivotal data on its experimental treatment for heavy menstrual bleeding triggered by uterine fibroids.

ObsEva in-licensed the drug, linzagolix, from Japan’s Kissei Pharmaceutical in 2015. Two doses of the drug (100 mg and 200 mg) were tested against a placebo in the 535-patient Phase III study, dubbed PRIMROSE 2, in patients who were both on and off hormonal add-back therapy (ABT).

Ear­ly-stage can­cer biotech nails $85M C round; Flem­ming Orn­skov's Gal­der­ma scores 'break­through' sta­tus

→ Zentalis Pharmaceuticals just nabbed an $85 million round from a syndicate that includes Matrix Capital, Viking Global Investors, Redmile Group, Farallon Capital, Perceptive Advisors, Surveyor Capital and Eventide Asset Management. Their lead drug is ZN-c5, which is currently in Phase I/II trials. The biotech describes that drug as a “potential best-in-class oral Selective Estrogen Receptor Degrader for estrogen receptor-positive, HER2-negative (ER+/ HER2-) breast cancer.”