Pear Therapeutics president and CEO Corey McCann (Pear)

Pear Ther­a­peu­tics nabs $80M Se­ries D to com­mer­cial­ize three dig­i­tal ther­a­peu­tics

As the pan­dem­ic rages on, vir­tu­al care op­tions have in­vestors champ­ing at the bit. Boston-based Pear Ther­a­peu­tics is the lat­est to ben­e­fit, reel­ing in $80 mil­lion to com­mer­cial­ize its three pre­scrip­tion dig­i­tal ther­a­peu­tics.

The dig­i­tal ther­a­peu­tics um­brel­la en­com­pass­es tech­nol­o­gy like mo­bile apps and telemed­i­cine plat­forms de­signed to pre­vent, treat or man­age dis­ease. Some are used alone, while oth­ers are com­bined with med­ica­tion.

Pear’s re­SET, ap­proved in 2017, de­liv­ers cog­ni­tive be­hav­ioral ther­a­py to those with sub­stance abuse dis­or­der in out­pa­tients set­tings. Re­SET-O got ap­proval the fol­low­ing year for opi­oid use dis­or­der. And the biotech’s most re­cent OK came in March for an AI-pow­ered chron­ic in­som­nia ther­a­py called Som­ryst.

Som­ryst com­bines telemed­i­cine vis­its with dig­i­tal cog­ni­tive be­hav­ioral ther­a­py, de­liv­er­ing rec­om­men­da­tions — like when a pa­tient should sleep and rise — at the touch of a screen. In clin­i­cal stud­ies with more than 1,400 adults, the soft­ware re­duced the amount of time tak­en to fall asleep by 45%, and cut the amount of time spent awake at night by 52%, ac­cord­ing to Pear.

“We be­lieve pre­scrip­tion dig­i­tal ther­a­peu­tics are cre­at­ing a new cat­e­go­ry of med­i­cine,” Soft­Bank part­ner Kirthi­ga Red­dy said in a state­ment.

The re­cent Se­ries D — led by Soft­Bank Vi­sion Fund 2 — will be used to ac­cel­er­ate re­im­burse­ment cov­er­age and cre­ate a mar­ket ac­cess path­way for re­SET, re­SET-O and Som­ryst, Pear an­nounced. The in­fu­sion comes near­ly two years af­ter the biotech hooked a $64 mil­lion C round led by Temasek. They al­so chipped in to the Se­ries D, as well as 5AM Ven­tures, Ar­bore­tum Ven­tures, JAZZ Ven­ture Part­ners, No­var­tis, Crim­soNox, ED­BI, Forth Man­age­ment, Pi­lot House, Saris­sa Cap­i­tal, Shan­da Group, and QUAD In­vest­ment Man­age­ment.

“This over­sub­scribed round of fund­ing will al­low us to con­tin­ue to in­vest in the launch­es of our three com­mer­cial prod­ucts to ac­cel­er­ate rev­enue growth, which we in­tend to rein­vest in our ro­bust pipeline and plat­form,” Pear pres­i­dent and CEO Corey Mc­Cann said in a state­ment.

In ad­di­tion to its com­mer­cial prod­ucts, Pear is work­ing on oth­ers for ill­ness­es like schiz­o­phre­nia, PTSD and mi­graine dis­or­der.

No­var­tis paired with Pear back in March 2018 to work on the schiz­o­phre­nia and mul­ti­ple scle­ro­sis front. Its sub­sidiary San­doz joined forces with the start­up lat­er that year to launch re­SET. How­ev­er, San­doz pulled out of the deal in 2019, not long af­ter CEO Richard Fran­cis abrupt­ly re­signed. The move to sev­er ties with Pear rep­re­sent­ed a “re­in­forced fo­cus on and cap­i­tal al­lo­ca­tion for San­doz core busi­ness,” the com­pa­ny said at the time.

Pear isn’t the on­ly dig­i­tal­ly fo­cused biotech to catch in­vestors’ eyes this year. Med­able bagged a $91 mil­lion Se­ries C to build out its vir­tu­al clin­i­cal tri­al plat­form at the end of last month, and Sci­ence 37 closed a $40 mil­lion fund­ing round to do the same in Au­gust. Sci­ence 37’s round in­clud­ed in­vest­ments from No­var­tis, Am­gen and Sanofi Ven­tures.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Tillman Gerngross (Adagio)

Till­man Gern­gross' Covid-19 an­ti­body moon­shot scores $336M with the help of new ace CFO. Is an IPO next?

Less than a year into its existence, serial biotech entrepreneur Tillman Gerngross’ antibody play Adagio has raced ahead into a pivotal trial for its lead drug for Covid-19 on the back of some very promising preclinical data. Now, crossover investors led by Peter Kolchinsky at RA are rolling up the Brinks truck — and that could spell an IPO in the offing for Adagio.

Adagio has bagged $336 million as part of a Series C round led by RA Capital to advance lead single-shot antibody ADG20 through a pivotal Phase I/II/III trial for the treatment of mild to moderate Covid-19 patients at high risk of infection, the biotech said Monday.

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UP­DAT­ED: New Kaiser analy­sis shows how lim­it­ing price ne­go­ti­a­tions to tar­get­ed drugs may bet­ter fo­cus up­com­ing leg­is­la­tion

As Congress considers whether to adopt sweeping new legislation to lower prescription drug prices across the board, the Kaiser Family Foundation is out with a new report on Monday showing how a more targeted approach on a subset of drugs might be a more efficient way to save government funds.

“This analysis shows that Medicare Part D and Part B spending is highly concentrated among a relatively small share of covered drugs, mainly those without generic or biosimilar competitors,” wrote Juliette Cubanski, deputy director of the program on Medicare policy at KFF, and Tricia Neuman, SVP of KFF. “Focusing drug price negotiation or reference pricing on a subset of drugs that account for a disproportionate share of spending would be an efficient use of administrative resources, though it would also leave some potential savings on the table.”

Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings

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

It was another busy week in the biotech IPO market as the second quarter continues to churn out significant investment into the sector.

Recursion led the way with a $436 million raise on Friday, pricing its IPO at $18, the high end of its range. Our own John Carroll went in depth on that raise over the weekend. Also on Friday, preclinical cancer biotech Biomea Fusion debuted with a $153 million raise priced at its own high end of $17 per share. The two companies helped push the combined IPO raise for 2021 to nearly $5.5 billion.

When is a drug re­al­ly a de­vice? Court knocks down FDA ap­peal in try­ing to sort that grey area

It’s always a surprise when a court has to step in to tell the FDA that it erred in performing one of its main duties: classifying whether a medical product is drug or a device.

But that’s what the US Court of Appeals for the District of Columbia did on Friday, making clear to the world’s top drug regulator that Genus Medical Technologies’ contrast agent barium sulfate (also known as Vanilla SilQ) should not be considered a drug, as the FDA had said, but a medical device.

Q1: A flood of in­vestor cash drove biotech's num­bers to new record highs, and the tor­rent of cash is mov­ing up­stream fast

If you thought biotech was booming last year, wait until you get a load of the numbers from Q1 2021.

On virtually every level, with one exception, the money engine was working around the clock in the first 3 months of this year. Venture capital has reached such a fever peak that the average B round now weighs in at an average mega-weight value of $100 million. The money flow is also finding its way to the mouth of the R&D river, where discovery work now merits the big bucks instead of cautionary seed funds.

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Jami Rubin (EQRx)

Ja­mi Ru­bin, once fa­bled for grilling bio­phar­ma ex­ecs, de­camps to head fi­nance at drug pric­ing dis­rupter

As Goldman Sachs’ top pharmaceutical analyst, Jami Rubin was known for asking the tough questions. Now, as she takes the lead on EQRx’s mission to rewrite the rules of drug pricing, we’ll see how good her answers are.

Rubin made the jump to biotech on April 5, becoming EQRx’s new CFO, the company said Monday. She’s coming from PJT Partners, where she’s been a partner providing strategic guidance for biotech and pharmaceutical companies for the last couple years. With EQRx’s recent $500 million Series B round in the books, it wouldn’t be a surprise if she was already lining up a public debut.

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Seagen gets Au­gust PDU­FA for Pad­cev ex­pan­sions; Adap­tate pulls in new cash for gam­ma delta T cell an­ti­bod­ies

Seagen is riding the wave of two new priority reviews straight to the FDA.

The Bothell, WA-based biotech and their partners at Astellas announced Monday that two supplemental BLAs for Padcev had been accepted by US regulators. FDA has set Aug. 17 as the PDUFA date for the reviews.

“With our recent regulatory submissions, we intend to provide the highest level of clinical evidence supporting Padcev use — overall survival data from a randomized Phase III trial — and expand availability in multiple countries where there is unmet medical need,” said Astellas oncology chief Andrew Krivoshik.