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.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.