Corey McCann, Pear Therapeutics CEO

The dig­i­tal health field con­tin­ues to boom as Soft­Bank-backed start­up hits uni­corn sta­tus in SPAC re­verse merg­er

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At the in­ter­sec­tion of med­i­cine and cut­ting-edge tech­nol­o­gy, the broad field of dig­i­tal health has seen boom­ing val­u­a­tions in re­cent months with some big-name in­vestors jump­ing in. Now, a com­pa­ny work­ing on soft­ware-based ther­a­peu­tics has leaped to uni­corn sta­tus and will take its show on the road to Nas­daq.

Pear Ther­a­peu­tics, a start­up de­vel­op­ing pre­scrip­tion dig­i­tal ther­a­peu­tics, will go pub­lic as part of a re­verse merg­er with a tech-fo­cused SPAC dubbed Thim­ble Point Ac­qui­si­tion Corp. that will val­ue the com­pa­ny at $1.6 bil­lion, the part­ners said Tues­day.

As part of the pact, Thim­ble Point will in­vest a to­tal of $400 mil­lion, with $276 mil­lion com­ing from the SPAC’s trust ac­count and the rest in PIPE fund­ing. The deal is ex­pect­ed to close in the sec­ond half of the year, and the new­co plans to trade un­der the tick­er $PEAR.

Pear cur­rent­ly sports three FDA-ap­proved PDTs, as they call them, which are stand­alone or com­ple­men­tary soft­ware prod­ucts that the biotech hopes to ex­tend in­to a range of ther­a­peu­tic ar­eas. The most re­cent prod­uct ap­proved was Som­ryst, a treat­ment for chron­ic in­som­nia that earned the FDA’s nod in March 2020.

In De­cem­ber, Pear closed an $80 mil­lion Se­ries D led by Japan’s Soft­Bank Vi­sion Fund 2. That round was ex­pand­ed to $100 mil­lion as an ad­di­tion­al in­vestor jumped on board in March.

On top of chron­ic in­som­nia, a mar­ket Pear es­ti­mates could hold around 30 mil­lion US pa­tients, the com­pa­ny’s two oth­er prod­ucts tar­get opi­oid ad­dic­tion, an­oth­er field that could in­clude as many as 20 mil­lion pa­tients, it said. On top of in­vest­ing more funds in­to com­mer­cial­iza­tion plans, Pear will look to build its pipeline, which in­cludes 14 in­ves­ti­ga­tion­al prod­ucts, the com­pa­ny said in a state­ment.

Elon Boms

“Thim­ble Point sought to col­lab­o­rate with a high-growth, tech-en­abled com­pa­ny with the po­ten­tial to dis­rupt large and es­tab­lished in­dus­tries,” the SPAC’s CEO, Elon Boms, said in a state­ment. “We chose to in­vest in Pear be­cause we be­lieve it has the op­por­tu­ni­ty to be­come the pri­ma­ry com­mer­cial plat­form through which pa­tients and pre­scribers ac­cess PDTs. Our growth cap­i­tal comes at an in­flec­tion point for Pear, as the team works to­wards ex­pect­ed near-term val­ue cre­ation mile­stones.”

Thim­ble Point went pub­lic back in Feb­ru­ary with a $240 mil­lion IPO and the goal “to fo­cus on high-growth soft­ware and tech­nol­o­gy-en­abled com­pa­nies that are dis­rupt­ing large and es­tab­lished in­dus­tries and mar­kets,” the blank-check com­pa­ny said in its prospec­tus. The team be­hind Thim­ble Point starts with Boms, the man­ag­ing di­rec­tor at the Pritzk­er Vlock Fam­i­ly Of­fice and co-founder and chair­man of Launch­Cap­i­tal.

Pear comes with the No­var­tis brand name at its back af­ter sign­ing a deal with the Swiss drug­mak­er in March 2018 to work on the schiz­o­phre­nia and mul­ti­ple scle­ro­sis front. No­var­tis gener­ics sub­sidiary San­doz al­so joined up to help launch opi­oid PDT re­SET in late 2018 but backed out af­ter re­jig­ging its port­fo­lio af­ter the de­par­ture of CEO Richard Fran­cis.

Pear is part of a wave of dig­i­tal health plat­forms that have earned mas­sive val­u­a­tions in re­cent months. Just last month, de­cen­tral­ized clin­i­cal tri­al play­er Sci­ence 37 went pub­lic as part of its own SPAC re­verse merg­er, earn­ing a val­u­a­tion at a lit­tle more than $1 bil­lion.

Mean­while, ge­net­ics test­ing com­pa­ny 23andMe went pub­lic back in Feb­ru­ary as part of a re­verse merg­er with a SPAC from bil­lion­aire Richard Bran­son. That deal val­ued the com­pa­ny at a whop­ping $3.5 bil­lion.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

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In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

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Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

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UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A handful of biotechs are hitting Wall Street just before the start of the weekend, with three companies — Caribou Biosciences, Sophia Genetics and Absci — all pricing big raises Wednesday and Thursday. Gamma delta T cell-focused IN8bio relaunched its IPO campaign months after postponing it last November, seeking a slightly lower raise. And another SPAC has filed for a public debut.

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Victor Perlroth, Kodiak Sciences CEO

Ko­di­ak turns down $125M pay­ment from Bak­er Bros. deal, slash­es roy­al­ty cap by 55%

Following a massive public raise last November, Kodiak Sciences has re-worked a royalty sale agreement with an old partner — and declined new funds in the process.

Kodiak is turning down a planned $125 million payment from Baker Bros. Advisors, according to an SEC filing, cutting short an agreement that saw the biotech hand over a 4.5% stream of royalty sales on its experimental anti-VEGF therapy KSI-301 for retinal vascular diseases. In conjunction with the move, Kodiak is shrinking the royalty cap from just over $1 billion to $450 million.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

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John Houston, Arvinas CEO

Pfiz­er bets $1B cash on the orig­i­nal pro­tein de­graders as tech­nol­o­gy nears prime time

As one of the largest multinational corporations in the world, Pfizer has its tendrils in everything. The Big Pharma has potentially hundreds of billions of dollars to play with, and when it decides to go big, it can go as big as it wants.

And did Pfizer ever on Thursday.

Returning to one of its partners in protein degradation, Pfizer is teaming up again with Arvinas to advance and vastly expand a program for breast cancer. As part of the deal, Pfizer is handing over $1 billion immediately — $650 million in upfront cash and $350 million in an equity investment — and promising up to another $1.4 billion in regulatory and commercial milestones.

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