2020's IPO par­ty con­tin­ues with four new Nas­daq en­trants, in­clud­ing Cov­il­lion­aire Carl Hansen's Ab­Cellera

Three more com­pa­nies are mak­ing their Wall Street de­buts Fri­day as the in­dus­try’s record-break­ing IPO year nears a con­clu­sion, with two mas­sive rais­es in the group — in­clud­ing the newest Cov­il­lion­aire’s out­fit.

The biotechs Ab­Cellera, 4D Mol­e­c­u­lar Ther­a­peu­tics and Nanobi­otix, as well as biosim­u­la­tion com­pa­ny Cer­tara, all priced late Thurs­day. Cer­tara raised the most of the bunch at a whop­ping $668 mil­lion, while Carl Hansen’s Ab­Cellera neared the half-bil­lion mark at $483 mil­lion. 4DMT raised $193.2 mil­lion in its sec­ond IPO go-around, and Nanobi­otix fol­lowed up with a $99 mil­lion raise of their own.

In terms of pric­ing, Cer­tara, 4DMT and Ab­Cellera priced above their ranges at $23, $23 and $20 per share, re­spec­tive­ly. Nanobi­otix came in at the low end with $13.50 per share.

The com­pa­nies’ Nas­daq tick­ers will be as fol­lows: Ab­Cellera has claimed $AB­CL, Cer­ta­ta is $CERT, 4DMT is pen­ciled in for $FDMT and Nanobi­otix gets $NBTX.

It’s been any­thing but a nor­mal year for IPOs in biotech, with num­bers and rais­es sky­rock­et­ing de­spite a ham­pered econ­o­my and the coun­try’s worst health cri­sis in a cen­tu­ry. As of Dec. 4, the to­tal amount of IPOs stood at 82, ac­cord­ing to Nas­daq head of health­care list­ings Jor­dan Saxe, who told End­points News the com­pa­nies com­bined to raise over $14 bil­lion this year.

There had been no more than 56 biotechs to go pub­lic in any of the pre­vi­ous three years, with that to­tal com­ing in 2018, per in­de­pen­dent an­a­lyst Brad Lon­car. Saxe had count­ed 72 IPOs in 2018, but both tal­lies had long been eclipsed by the un­end­ing pa­rade of de­buts the in­dus­try has seen this year.

Ab­Cellera is the high­est-pro­file com­pa­ny of the group, with Hansen set to join the ex­clu­sive Cov­il­lion­aire club on the heels of the com­pa­ny’s sky­rock­et­ing val­ue. Hansen has kept hold of what will be a 23% stake in the com­pa­ny, con­trol­ling 61,827,830 shares, with Ab­Cellera’s mar­ket cap eas­i­ly ex­ceed­ing the $5 bil­lion es­ti­mate from the mid­dle of its ex­pect­ed range.

The biotech’s part­ner­ship with Eli Lil­ly has proved fruit­ful, with the com­pa­nies team­ing up on a Covid-19 an­ti­body where ques­tions re­main de­spite re­ceiv­ing emer­gency use au­tho­riza­tion last month. And re­cent­ly, bil­lion­aire Pe­ter Thiel joined the com­pa­ny’s board of di­rec­tors af­ter Ab­Cellera scooped up sev­er­al “next-gen­er­a­tion” mice un­der de­vel­op­ment.

Cer­tara, which is owned by Swedish pri­vate eq­ui­ty firm EQT, cre­ates biosim­u­la­tion soft­ware and of­fers tech­nol­o­gy-en­abled ser­vices. The com­pa­ny says 17 reg­u­la­to­ry agen­cies world­wide use their soft­ware, in­clud­ing the FDA and EMA. Per the com­pa­ny’s S-1, it ex­pects to use most of the $668 mil­lion raise to pay off debt, with the rest go­ing to gen­er­al ad­min­is­tra­tive pur­pos­es.

4DMT had orig­i­nal­ly sought a $100 mil­lion IPO back in Sep­tem­ber 2019, but with­drew its fil­ing af­ter com­plet­ing a $75 mil­lion Se­ries C in­stead. The com­pa­ny list­ed in its new S-1 that on­go­ing clin­i­cal tri­als for their lead­ing pro­grams 4D-310 and 4D-125 would be their top pri­or­i­ties with the fund­ing. Both of those can­di­dates are cur­rent­ly in Phase I/II with da­ta like­ly com­ing next year.

Nanobi­otix, a French biotech, is re­search­ing how its nan­otech­nol­o­gy plat­form can im­prove the ef­fi­ca­cy of ra­dio­ther­a­py can­cer treat­ments. Its lead can­di­date, NBTXR3, con­tains nanopar­ti­cles sus­pend­ed in a liq­uid — when in­ject­ed in­to a tu­mor and ex­posed to ra­di­a­tion, the com­pa­ny says the pro­gram am­pli­fies the ef­fects of the ra­di­a­tion and spurs an im­mune re­sponse.

They’ve run eight clin­i­cal tri­als with this pro­gram so far, and in Sep­tem­ber part­nered with MD An­der­son to launch a Phase I study in pan­cre­at­ic can­cer. Per the com­pa­ny’s F-1, they ex­pect to use about $58.1 mil­lion on a Phase III tri­al for head and neck can­cers in el­der­ly pa­tients in­el­i­gi­ble for cis­platin chemo, with an­oth­er $20.6 mil­lion go­ing to the rest of their stud­ies.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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Pfiz­er will in­vest $1.2B+ in Irish man­u­fac­tur­ing site, adding 500 em­ploy­ees

Covid-19 trailblazer Pfizer has confirmed its commitment to a large expansion project on the Emerald Isle.

The New York-based company announced on Thursday that it will make a €1.2 billion ($1.26 billion) capital investment into its manufacturing site at Grange Castle in Dublin.

The expansion of the site marks Pfizer’s largest expansion investment in Ireland to date. The expansion includes the construction of a new facility on the premises as well as adding in more laboratory space and will ultimately double the capacity for “biological drug substance manufacturing” in the oncology and rare disease space as well as inflammation, immunology and internal medicines.

In­tel­lia and Iver­ic sell stocks to raise mon­ey, each net­ting $300M

Wednesday afternoon, Gene editing company Intellia and eye disease company Iveric Bio announced that they had each raised $300 million by selling off some of their stocks. The two biotechs are the latest to raise money via public stock offerings, an increasingly popular tactic used by public companies as the industry falls back from its pandemic boom.

Intellia’s raise comes a few weeks after it posted an update on its hereditary angioedema program that uses CRISPR/Cas9 to directly edit the gene that makes the protein responsible for the attacks that occur with the disease. In that interim cut, Intellia showed that patients dosed with its one-time therapy became attack free (at least thus far) after an observation period of 16 weeks, with the longest patient remaining attack free for 10 months.

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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