Bio­phar­ma IPO boom yields buoy­ant biotech pub­lic de­buts

The past week has seen a smor­gas­bord of big­ger-than-ex­pect­ed bio­phar­ma IPO de­buts led by Chi­nese biotech Leg­end, as in­vestors put their chips on the in­dus­try that is ex­pect­ed to be the tick­et out of the pro­tract­ed Covid-19 cri­sis — amid a broad­er mar­ket that is com­ing back to life with US busi­ness­es grad­u­al­ly re­open­ing.

The J&J-part­nered com­pa­ny not on­ly emerged with one of the largest pub­lic rais­es in biotech his­to­ry clock­ing in meaty $424 mil­lion, but saw its shares $LEGN soar more than 60% on its first day of trad­ing.

Leg­end — which si­lenced skep­tics such as ri­val Blue­bird bio’s Nick Leschly by earn­ing the part­ner­ship with J&J in an $350-mil­lion up­front deal for its CAR-T ther­a­py — had orig­i­nal­ly filed for a healthy $350 mil­lion IPO, based on a range of $18-$20. But they man­aged to rake in $23 per share, set­ting the stage for a wind­fall that eclipsed mam­moth rais­es from peers in­clud­ing Juno and Gala­pa­gos, but short of Mod­er­na’s record-set­ting $600 mil­lion in 2018.

Leg­end’s lead ex­per­i­men­tal drug, pur­posed as the last line of de­fense for pa­tients with re­lapsed and re­frac­to­ry mul­ti­ple myelo­ma, is ex­pect­ed to be put un­der reg­u­la­to­ry re­view in the sec­ond half of 2020.

Oth­er biotech per­for­mances were al­so buoy­ant, ei­ther by pric­ing above the range or thanks to up­sized of­fer­ings.

No­var­tis-backed Pli­ant Ther­a­peu­tics, for in­stance, had pen­ciled in a $86 mil­lion raise back in May. But that ini­tial es­ti­mate, much like a clutch of oth­ers in re­cent weeks, was over­shad­owed with its ac­tu­al haul: $144 mil­lion. It priced at the high end of its range at $16, but sized up the to­tal shares of­fered to 9 mil­lion.

The South San Fran­cis­co biotech, which is al­lied with the Swiss drug­mak­er on an in­te­grin in­hibitor de­signed to tack­le fi­bro­sis as­so­ci­at­ed with NASH on the ba­sis of re­search con­duct­ed by sci­en­tif­ic co-founder Dean Shep­pard, raised $100 mil­lion ahead of the IPO in a round led by No­var­tis. The com­pa­ny’s tech­nol­o­gy, which al­so holds promise in fields such as on­col­o­gy and mus­cu­lar dy­s­tro­phy, is fo­cused on TGF-β ac­ti­va­tion. Flaunt­ing a $577 mil­lion mar­ket cap, Pli­ant $PLRX fin­ished its first day of trad­ing up a healthy 39%.

Neigh­bor­ing biotech Ap­plied Mol­e­c­u­lar Trans­port al­so up­sized its of­fer­ing gen­er­at­ing a $154 mil­lion yield, well above its ini­tial $100 mil­lion es­ti­mate. The com­pa­ny, which jumped on the IPO band­wag­on per­haps more out of ne­ces­si­ty than am­bi­tion af­ter de­clar­ing sub­stan­tial doubts about its abil­i­ty to con­tin­ue as a go­ing con­cern at the end of the first quar­ter, has an in­flam­ma­to­ry-dis­ease fo­cused pipeline.

Its lead drug, AMT-101, is an IL-10 ag­o­nist en­gi­neered to tamp down in­flam­ma­tion in au­toim­mune dis­or­ders such as ul­cer­a­tive col­i­tis and rheuma­toid arthri­tis. Shares of the ear­ly-stage drug de­vel­op­er, found­ed and led by life sci­ences con­sul­tant Tahir Mah­mood, rose $AMTI 28% on its first day, grant­i­ng it a re­spectable half a bil­lion dol­lar mar­ket cap.

Fi­nal­ly, the de­but for the first Swedish com­pa­ny to list on Nas­daq in 15 years al­so reaped gains ahead of the topline read­out of its Phase III drug ex­pect­ed by the end of this year. The com­pa­ny, Cal­lid­i­tas Ther­a­peu­tics, was ini­tial­ly eye­ing a $75 mil­lion raise but up­sized its deal to raise $90 mil­lion.

The com­pa­ny’s lead drug, Ne­fe­con, is an oral for­mu­la­tion of the cor­ti­cos­teroid budes­onide li­censed from Up­p­sala Uni­ver­si­ty. The biotech has been de­vel­op­ing the drug for use in an or­phan au­toim­mune re­nal dis­ease known as IgA nephropa­thy (IgAN). En­gi­neered as an im­muno­sup­pres­sant, the drug is de­signed to keep pa­tients from pro­gress­ing to end-stage re­nal dis­ease. Shares of the com­pa­ny $CALT ticked up about 1% on its first day, mark­ing a $476 mil­lion mar­ket cap.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

Joe Biden (Carolyn Kaster, AP Images)

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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