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.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

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Angie You (file photo)

With $117M in fresh cash, Amu­nix paves path to the clin­ic for 'u­ni­ver­sal mask' pro­drug on the hunt for HER2 tu­mors

Despite all the excitement over the possibility of T cell therapies to crack the code against solid tumors, early safety data have limited the burgeoning field’s promise. A clutch of players hope to solve that problem by “masking” their drugs, and now one of those outfits has snared fresh investor cash to take its shot in the clinic.

Amunix closed a $117 million Series B to guide AMX-818, a masked protease-activated T cell engager for HER2 expressing tumors, to the clinic as well as shepherding its bustling pipeline of tumor hunters through the preclinical stage, the company said Thursday.

Andrew Hopkins, Exscientia

Black­Rock push­es Ex­sci­en­tia Se­ries C to $100M as AI biotech boom con­tin­ues

The jury’s still out on whether the first wave of AI companies can significantly change drug development, but investors are increasingly buying into the hype.

Exscientia, the decade-old UK machine learning outfit, announced Thursday that they’ve expanded their Series C, first announced in May, from $60 million to $100 million. The expansion most notably includes BlackRock, the private equity firm that has been wading deeper and deeper into biotech. They now join Novo Holdings, Bristol Myers Squibb and others among the company’s most recent backers.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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