IPOs abound in the time of coro­n­avirus, as For­ma Ther­a­peu­tics pen­cils in $150M Nas­daq de­but

The IPO en­gine is thriv­ing, nev­er mind the ram­page of the coro­n­avirus cri­sis on R&D time­lines.

On Fri­day, along with syn­thet­ic lethal­i­ty-fo­cused biotech Re­pare Ther­a­peu­tics, an­oth­er Bris­tol My­ers part­ner For­ma Ther­a­peu­tics al­so un­veiled its plans to vault on to the Nas­daq — pen­cil­ing in a tar­get of $150 mil­lion.

Frank Lee

The Wa­ter­town, Mass­a­chu­setts-based com­pa­ny — which poached se­nior Genen­tech ex­ec­u­tive Frank Lee to take over the reins last year af­ter more than a decade un­der founder Steve Tre­gay — raised a plump $100 mil­lion late last year, while shep­herd­ing its sick­le cell dis­ease (SCD) drug through an ear­ly-stage tri­al.

Last No­vem­ber, the FDA ush­ered in the ap­proval of two SCD ther­a­pies, in­ject­ing some op­ti­mism in­to an oth­er­wise bar­ren treat­ment land­scape for pa­tients with the blood dis­or­der that is char­ac­ter­ized by atyp­i­cal he­mo­glo­bin mol­e­cules, which can dis­tort red blood cells in­to a sick­le, or cres­cent, shape. No­var­tis’ ther­a­py, Adakveo, is de­signed to pre­vent pe­ri­od­ic episodes of sear­ing pain called va­so-oc­clu­sive crises (VOCs) that de­prive the de­prive the body of oxy­gen-rich blood, while Glob­al Blood Ther­a­peu­tics’ vox­elo­tor is de­signed to work by in­creas­ing he­mo­glo­bin’s affin­i­ty for oxy­gen.

In­stead of ad­dress­ing symp­toms of SCD, For­ma’s lead ther­a­py, FT-4202, is de­signed to change the course of the dis­ease as an ac­ti­va­tor of the en­zyme pyru­vate ki­nase-R (PKR) to im­prove red blood cell me­tab­o­lism, func­tion and sur­vival, po­ten­tial­ly re­sult­ing in both in­creased he­mo­glo­bin lev­els and few­er VOCs. For­ma is in a crowd­ed field of ther­a­pies in de­vel­op­ment, with oth­er drug­mak­ers in­clud­ing blue­bird bio, Imara, and part­ners CRISPR Ther­a­peu­tics and Ver­tex, al­so work­ing on their own drugs.

Mean­while, For­ma al­so plans to eval­u­ate the use of FT-4202 in be­ta tha­lassemia. The com­pa­ny al­so has a brim­ming pipeline, in­clud­ing an AML drug and a NASH ther­a­py in mid-stage de­vel­op­ment, as well as ear­li­er-stage com­pounds for NASH, NHL (part­nered with Bris­tol My­ers Squibb)  and sol­id tu­mors (in col­lab­o­ra­tion with Boehringer In­gel­heim).

There has been a flur­ry of bio­phar­ma IPO’s in re­cent­ly — Gen­er­a­tion Bio, Avid­i­ty and Vax­cyte set their sights on a com­bined $325 mil­lion and the week be­fore ADC Ther­a­peu­tics raked in $233 mil­lion in an up­sized of­fer­ing — de­spite the gen­er­al pan­de­mo­ni­um on Wall Street due to Covid-19. But the life sci­ences sec­tor has emerged large­ly im­mune from the rout.

Swe­den’s Cal­lid­i­tas, which last week said it was eye­ing a $75 mil­lion raise (a mod­est sum com­pared to some of the splashier pub­lic de­buts seen in re­cent weeks), on Mon­day in­di­cat­ed it was com­menc­ing an in­vestor road­show. The com­pa­ny, which is de­vel­op­ing a ther­a­py for an or­phan kid­ney dis­ease, al­ready has a Swedish list­ing.

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Andrea Pfeifer, AC Immune CEO (AC Immune)

Look­ing to repli­cate Covid-19 suc­cess in neu­ro, BioN­Tech back­ers bet on AC Im­mune and its new­ly-ac­quired Parkin­son's vac­cine

The German billionaires behind BioNTech have found a new vaccine project to back.

Through their family office Athos Service, twin brothers Thomas and Andreas Strüngmann are leading a $25 million private placement into Switzerland’s AC Immune — which concurrently announced that it’s shelling out $58.7 million worth of stock to acquire Affiris’ portfolio of therapies targeting alpha-synuclein, including a vaccine candidate, for Parkinson’s disease.

Rajiv Shukla, Constellation Alpha Holdings

Can­del gets busy IPO week mov­ing with down­sized raise as Ra­jiv Shuk­la's third SPAC goes pub­lic

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

In a week that’s expected to see several biotechs price their IPOs, Candel Therapeutics got things kicked off Tuesday with a muted opener.

The company helmed by former GlaxoSmithKline vet Paul Peter Tak made its way to Nasdaq thanks to a $72 million raise, which was downsized by about 15% than originally anticipated, according to Renaissance Capital. Candel priced at $8 per share after initially seeking to launch in the $13 to $15 range.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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