Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Dan­ish drug­mak­er Gen­mab A/S is off to the races with per­haps one of the biggest biotech pub­lic list­ings in decades, hav­ing reaped over $500 mil­lion on the Nas­daq, as it po­si­tions it­self as a bonafide play­er in an­ti­body-based can­cer ther­a­pies.

The com­pa­ny, which has long served as J&J’s $JNJ key part­ner on the block­buster mul­ti­ple myelo­ma ther­a­py Darza­lex, has as­sert­ed it has been look­ing to launch its own pro­pri­etary prod­uct — one it owns at least half of — by 2025.

There are at least five such prod­ucts — which Gen­mab has fond­ly chris­tened “knock-your-socks-off an­ti­bod­ies” — in­clud­ing an an­ti­body-drug con­ju­gate (ADC) called ti­so­tum­ab ve­dotin be­ing co-de­vel­oped with Seat­tle Ge­net­ics $SGEN, and an­oth­er ADC called enapotam­ab ve­dotin that the com­pa­ny ful­ly owns. Then there’s an an­ti­body tar­get­ing sol­id tu­mors called Hexa­Body-DR5/DR5 as well as a bis­pe­cif­ic an­ti­body en­gi­neered to fight B-cell ma­lig­nan­cies called Duo­Body-CD3xCD20 — which are al­so ful­ly owned by Gen­mab. Fi­nal­ly, there’s an­oth­er bis­pe­cif­ic an­ti­body — Duo­Body-PD-L1x4-1BB — whose de­vel­op­ment is split with BioN­Tech.

Apart from these, the Copen­hagen based com­pa­ny has a string of oth­er part­ners: Gilead $GILD, No­vo Nordisk $NVO, Am­gen $AMGN, Im­mat­ics and ADC Ther­a­peu­tics.

On Thurs­day, the Copen­hagen-based com­pa­ny said it gen­er­at­ed gross pro­ceeds of $505,875,000 by sell­ing 2,850,000 or­di­nary shares of Gen­mab in the form of 28.5 mil­lion Amer­i­can De­posi­tary Shares (ADSs) at a price of $17.75 per ADS. It is set to trade un­der the sym­bol “GMAB”.

Last week, the com­pa­ny had set out the po­ten­tial terms of its IPO: with a plan to sell 27.8 mil­lion shares at $18.11 per ADS, which would have trans­lat­ed to a mar­ket cap of a whop­ping $11.8 bil­lion.

Darza­lex, which raked in $90 mil­lion in mile­stone pay­ments and $262 mil­lion in roy­al­ties and ac­count­ed for near­ly 76% of Gen­mab’s 2018 rev­enue, cur­rent­ly is be­ing test­ed in mul­ti­ple tri­als in a bid to ex­pand its use. Mean­while, com­pe­ti­tion from Sanofi $SNY is loom­ing.

Mike Grey Linkedin

Gen­mab’s oth­er mar­ket­ed treat­ment Arz­er­ra — part­nered with No­var­tis $NVS — has not fared as well. Last year, the Swiss drug­mak­er record­ed net sales of $26 mil­lion — gen­er­at­ing rough­ly $5 mil­lion in roy­al­ties for Gen­mab. The drug has been cleared for use in chron­ic lym­pho­cyt­ic leukemia and is now be­ing stud­ied for mul­ti­ple scle­ro­sis.

There were an­oth­er cou­ple of small­er IPO pric­ings on Wednes­day.

Af­ter wrest­ing con­trol of two liv­er drugs from Shire and prim­ing them for piv­otal tri­als — Mirum Phar­ma­ceu­ti­cals’ Mike Grey has steered the Cal­i­for­nia biotech to a $75 mil­lion IPO. The two drugs — mar­al­ix­i­bat and volix­i­bat — cost Mirum $7.5 mil­lion up­front. Shire — now part of Take­da — had wa­gered $260 mil­lion on Lu­me­na (where Grey was once CEO) large­ly on the promise of these two as­sets, which both tar­get the api­cal sodi­um-de­pen­dent bile acid trans­porter, a pro­tein ex­pressed in the small in­tes­tine.

Bob Gould Ful­crum

The com­pa­ny — which has raised $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber — has sold 5 mil­lion shares at $15/share — at the mid­point of its range of $14 to $16. It is set to trade on the Nas­daq on Thurs­day un­der the sym­bol “MIRM”.

While on the east coast, Ful­crum Ther­a­peu­tics has raised gross pro­ceeds of $72 mil­lion, by sell­ing 4.5 mil­lion shares at $16/share — the low­er end of its range of $16 to $18.

The Cam­bridge, Mass­a­chu­setts-based com­pa­ny — which raised $80 mil­lion in a Se­ries B round to shep­herd the first of its gene-reg­u­lat­ing small mol­e­cules in­to the clin­ic last Sep­tem­ber — is run by biotech vet­er­an Bob Gould who for­mer­ly served as Epizyme’s chief. The com­pa­ny is set to trade on Thurs­day un­der the sym­bol “FULC” on the Nas­daq.

So­cial im­age: Shut­ter­stock

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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David Hallal

AlloVir tests how much an an­tivi­ral biotech can reap in a pan­dem­ic stock mar­ket

The pandemic stock market has proven fruitful for virtually any type of biotech. Now a 7-year-old cell therapy startup will see how much it can yield for a company that specializes in fighting viruses.

AlloVir, a company that until 2019 largely lived off grant money, has filed for a $100 million IPO to back its line of off-the-shelf, virus-fighting T cells. Although in normal circumstances, $100 million could be a solid return for a biotech that got its first major round of funding only last year, we’ll have to wait to see how much the company ultimately earns. As Covid-19 has sent investor money scurrying to almost anyone in drug development, every single biotech to go public this year has prized above their midpoint or upsized their offering, according to Renaissance Capital, sometimes dramatically so.

Noubar Afeyan, Flagship CEO and Tessera chairman (Victor Boyko/Getty Images)

Flag­ship ex­ecs take a les­son from na­ture to mas­ter ‘gene writ­ing,’ launch­ing a star-stud­ded biotech with big am­bi­tions to cure dis­ease

Flagship Pioneering has opened up its deep pockets to fund a biotech upstart out to revolutionize the whole gene therapy/gene editing field — before gene editing has even made it to the market. And they’ve surrounded themselves with some marquee scientists and execs who have crowded around to help shepherd the technology ahead.

The lead player here is Flagship general partner Geoff von Maltzahn, an MIT-trained synthetic biologist who set out in 2018 to do CRISPR — a widely used gene editing tool — and other rival technologies one or two better. Von Maltzahn has been working with Sana co-founder Jake Rubens, another synthetic biology player out of MIT who he describes as his “superstar,” who’s taken the CSO role.

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Covid-19 roundup: Squab­bles with gov­ern­ment de­lay Mod­er­na’s PhI­II — re­ports; No­vavax se­cures largest Warp Speed deal yet: $1.6B

A much-anticipated Phase III trial for Moderna’s Covid-19 vaccine is being held up as the company delayed submitting trial protocols and sparred with government scientists on how to run the study and even what the benchmark for success should be, Reuters reported.

Moderna, the first US company to put their vaccine into human testing, was supposed to enter a 30,000-person study this month in partnership with the NIH to determine whether it can prevent infection. STAT reported last week that the trial was facing delays over the protocol, but that a July start was still possible. Neither the NIH nor Moderna ever disclosed a specific date the trial should start, but Reuters reported that the agency had hoped to begin on July 10.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? Ac­tu­al­ly, An­nex­on was al­ready prepped and primed to toss its S-1 to Wall Street as in­vestors ral­lied

The Wall Street IPO shuffle generally calls for a little distance between the crossover ante and the Wall Street double, but with the window on the street wide open and biotech sizzling hot, who’s waiting?

The crew at Annexon didn’t leave anyone in suspense for long about their IPO plans. A day after the Bay Area biotech with clinical plans to target neurodegeneration quietly unveiled a $100 million raise, they were back with an S-1 outlining a pitch to double that — or more.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Boehringer In­gel­heim ties the knot with Num­ab on new an­ti­bod­ies; Ca­balet­ta inks pact with Ar­ti­san

→ Switzerland’s Numab Therapeutics has added Boehringer Ingelheim to its roster of collaborators. And they will start with two projects aiming at developing new drugs for difficult-to-treat lung and gastrointestinal cancers and patients with geographic atrophy. “Numab’s technology platform fits well with our internal antibody discovery and engineering capabilities and will enhance our efforts to deliver transformative antibody-based therapeutics to patients,” said Paige Mahaney, an SVP at Boehringer Ingelheim.

Take­da’s post-merg­er deals con­tin­ue as OTC sub­sidiary is pre­pared for sale

Takeda has been burdened under mountains of debt since acquiring Shire for $62 billion 18 months ago, but one of the company’s biggest moves yet to relieve the stress could be on the horizon.

The Japanese pharma is preparing a bidding war for its $3.7 billion over-the-counter subsidiary, a sale that would dwarf previous spinoffs. Any transaction would be the latest in what’s been a long string of sell-offs, as Takeda marches unflinchingly toward its ultimate goal of shedding $10 billion in assets.