Bill Haney be­lieves there’s a bet­ter way to build a biotech — and now he has $100M more at Sky­hawk to prove it

Bill Haney

Bill Haney want­ed to do things dif­fer­ent­ly when he launched Sky­hawk Ther­a­peu­tics at the be­gin­ning of the year with $8 mil­lion in seed cash from some un­con­ven­tion­al biotech back­ers.

Now he has a $100 mil­lion more to fo­cus the team on step 3: 

“I think we start dri­ving drugs in­to the clin­ic,” he says.

Cel­gene — which has had more than its share of woes this year — will have a lot to do with that. The big biotech has un­corked one of its clas­sic start­up col­lab­o­ra­tions with Sky­hawk, drawn by the emerg­ing field of drug­ging RNA and the team of sci­en­tists at the biotech who are rac­ing to get out front with the new plat­form play. 

Cel­gene is pay­ing Haney and co-founder Kath­leen Mc­Carthy $60 mil­lion up­front to get them fo­cused on a line­up of new neu­ro­sciences pro­grams. The dis­ease tar­gets in­clude amy­otroph­ic lat­er­al scle­ro­sis — ALS — and Hunt­ing­ton’s dis­ease. And the com­pa­ny is buy­ing an eq­ui­ty stake as well, con­tribut­ing to­ward a $40 mil­lion raise along­side a group of in­vestors that in­cludes the Duke of Bed­ford, tech in­vestor Great­point and Alexan­dria Ven­ture In­vest­ments.

Kath­leen Mc­Carthy

Mile­stones? There Haney isn’t be­ing spe­cif­ic, but he did vol­un­teer that it’s big­ger than the $2 bil­lion pack­age Cel­gene hand­ed to Prothena when their ex­ecs aligned on a part­ner­ship aimed at con­struct­ing a new neu­ro­sciences pipeline.

Ex­cit­ed much? You could say that.

“I just love these guys,” says Haney, sin­gling out long­time de­vel­op­ment vet Richard Har­g­reaves and his team at Cel­gene for the ad­vice they’re get­ting. 

“You don’t want 4 hands on the wheel and co-dri­ve,” he adds. But gain­ing ad­vice to speed up the pre­clin­i­cal ef­fort comes in mighty handy, along with Cel­gene’s en­dorse­ment of a tech­nol­o­gy that al­so in­cludes key play­ers like Mike Gilman’s Ar­rakis, Ex­pan­sion Ther­a­peu­tics and Ri­bometrix.

Haney is back­ing the work of Mc­Carthy and her group of 25 staffers and FTEs work­ing on the start­up project. The Roche vet worked on the SMA drug RG7916 — a project that has now wound its way in­to piv­otal tri­als. 

Richard Har­g­reaves

“We will do more part­ner­ships,” says the CEO, “maybe one more this year.” He has some term sheets to look at and con­sid­er. In the mean­time, the com­pa­ny has kept on­col­o­gy for it­self so far, look­ing to build its own pipeline.

Haney is still quite new to biotech, ar­riv­ing with his oth­er com­pa­ny Drag­on­fly, which he found­ed with MIT’s Tyler Jacks and David Raulet out of Berke­ley. A doc­u­men­tary film­mak­er and chair­man of Blu Homes, Haney isn’t a fan of the Se­ries A-B-C-D ap­proach to rais­ing mon­ey through the ven­ture back­ers that fu­el much of the work. Why hand out com­mon shares to staff and pre­ferred stock to these in­vestors? And you have to con­sid­er that the VCs’ in­ter­ests may not align so well with longterm com­pa­ny build­ing.

So he’s been in­volved with fam­i­ly of­fices, work­ing with in­vestors like long­time friend and col­league Tim Dis­ney and oth­ers when rais­ing seed mon­ey. Haney has blazed a trail in the Boston/Cam­bridge biotech hub in short or­der. And he isn’t slow­ing down.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Novavax site in Gaithersburg, MD. Novavax

Beef­ing up its new gene ther­a­py unit, Catal­ent inks $18M deal to snap up No­vavax fa­cil­i­ties

Catal­ent’s hunt for rapid growth on the gene ther­a­py front — ce­ment­ed with a $1.2 bil­lion ac­qui­si­tion of Paragon Bio­sciences two months ago — has led them to the vac­cine mak­ers at No­vavax.

With an $18 mil­lion pay­ment, Paragon is tak­ing over two No­vavax sites in Gaithers­burg, MD, in­clud­ing more than 100 of the em­ploy­ees al­ready work­ing there. That’s in ad­di­tion to a sig­nif­i­cant re­duc­tion in op­er­at­ing costs, says the com­pa­ny, as No­vavax shifts to re­ly on Paragon for GMP ma­te­ri­als in clin­i­cal tri­als and, even­tu­al­ly, com­mer­cial sup­ply of their prod­ucts.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Image: Chris Varma. Frontier

UP­DAT­ED: Chris Var­ma un­veils MP­M's lat­est start­up — eye­ing 'un­drug­gable' can­cer tar­gets and pow­ered by ma­chine learn­ing, $67M

Two years af­ter MPM Cap­i­tal en­list­ed Chris Var­ma on its busy on­col­o­gy team, the for­mer en­tre­pre­neur-in-res­i­dence is un­veil­ing his first ven­ture project out of his new stomp­ing grounds in the Bay Area: Fron­tier Med­i­cines.

For Var­ma, who’s al­so co-found­ed Blue­print Med­i­cines and built com­pa­nies at Third Rock and Flag­ship, this marks an­oth­er op­por­tu­ni­ty to ap­ply some cut­ting-edge sci­ence to “sev­er­al of the most im­por­tant and dif­fi­cult tar­gets in can­cer” — tar­gets that oth­ers have tried to tack­le with more clas­si­cal meth­ods and failed. The launch round comes in at $67 mil­lion, which should go some way in scaf­fold­ing a pre­clin­i­cal pipeline and push one or more as­sets in­to the clin­ic three years from now, he tells me.