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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Patrik Jonsson, the president of Lilly Bio-Medicines

Who knew? Der­mi­ra’s board kept watch as its stock price tracked Eli Lil­ly’s se­cret bid­ding on a $1.1B buy­out

In just 8 days, from December 6 to December 14, the stock jumped from $7.88 to $12.70 — just under the initial $13 bid. There was no hard news about the company that would explain a rise like that tracking closely to the bid offer, raising the obvious question of whether insider info has leaked out to traders.

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Short at­tack­er Sahm Ad­ran­gi draws crosshairs over a fa­vorite of Sanofi’s new CEO — with PhII da­ta loom­ing

Sahm Adrang Kerrisdale

Kerrisdale chief Sahm Adrangi took a lengthy break from his series of biotech short attacks after his chief analyst in the field pulled up stakes and went solo. But he’s making a return to drug development this morning, drawing crosshairs over a company that’s one of new Sanofi CEO Paul Hudson’s favorite collaborators.

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Sor­ren­to shrugs off an anony­mous pri­vate eq­ui­ty group’s $1B of­fer to buy the com­pa­ny

San Diego-based Sorrento Therapeutics isn’t going the M&A route — at least not today.

The biotech caused quite a stir when it put out word a few weeks ago that an unidentified private equity group was bidding a billion dollars-plus for the company. The news drove a quick spike in the company’s share price as investors hooked up for the ride — that didn’t happen.

The update sparked a 5% drop in the share price $SRNE ahead of the bell. It’s now trading just above $4, without any evidence that the $7 price looked like it was firm.

UP­DAT­ED: Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

AbbVie is donating more than $1 million worth of an HIV drug to help combat the fast-spreading coronavirus outbreak in China, the company announced on Friday.

China’s National Health Commission has suggested Aluvia, a pill containing lopinavir and ritonavir, as one of two possible treatments for the symptoms of the virus currently known as 2019-nCoV in the absence of effective antiviral medications. The other part is nebulized alpha-interferon.

UP­DAT­ED: Ab­b­Vie and Al­ler­gan di­vesti­tures are in, and an old As­traZeneca drug comes home

When AbbVie announced their $63-billion Allergan acquisition last year, executives acknowledged the two companies would have to divest some drugs to satisfy regulators. The two main assets in discussion have now been sold off – and one of them is coming home.

AstraZeneca will acquire brazikumab, Allergan’s late-stage IL-23 candidate for Crohn’s disease and ulcerative colitis. The drug was originally developed by AstraZeneca’s defunct subsidiary MedImmune, in collaboration with Amgen. Allergan licensed it for $250 million upfront and $1.27 billion in milestones.

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As­traZeneca makes case for use of blood thin­ner Bril­in­ta in stroke pa­tients

AstraZeneca’s extravagant projections for its clot fighter Brilinta may have fizzled in the face of underwhelming trial data — but a new pivotal study is set to expand its use substantially.

On Monday, the British drugmaker said the drug, when taken in conjunction with aspirin, induced a statistically significant reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone, in 11,000 patients that have suffered minor acute ischaemic stroke or a high-risk transient ischemic attack (TIA).

Samantha Truex (file photo)

Bruce Booth and Saman­tha Truex's lat­est ven­ture aims just above Hu­mi­ra

In 2000, about a year after the first trial data on Humira came out, a Japanese team identified a new gene that appeared to prevent GI cancer in mice: gasdermin, they called it, after the particular proteins it expressed.

Over the next decade-and-a-half, researchers found five more genes in the same family – often identified as gasdermin A, B, C, D, E and F – and yet their purpose baffled scientists. Mutations in appeared to make mice bald (alopecia), but deleting it had no effect. Mutations in F and A were linked to deafness. Mutant E caused human cells to self-destruct.

“The exact biological function of these proteins remained unknown for more than 15 years,” three of the field’s top researchers wrote in a  Nature review in November.

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FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

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