The biotech IPO boom is be­com­ing ‘his­toric’ as four more throw their hats in

Four more US biotechs filed to go pub­lic Fri­day as yet more com­pa­nies clam­ber to get through a yawn­ing IPO win­dow and on­to a mar­ket that’s sig­naled its will­ing­ness to re­ward near­ly any new drug­mak­er.

The new en­trants are led by ALX On­col­o­gy and the bi­o­log­i­cal an­a­lyt­ics biotech Berke­ley Lights, each of whom filed to raise $100 mil­lion. The au­toim­mune com­pa­ny Pan­dion Ther­a­peu­tics al­so filed for $75 mil­lion, and Kiromic Bio­phar­ma, a tiny im­muno-on­col­o­gy start­up based in San An­to­nio, filed for $25 mil­lion.

These com­pa­nies will try to cap­i­tal­ize on a 2020 biotech IPO boom that the in­vest­ment firm Re­nais­sance Cap­i­tal re­cent­ly called “his­toric.” The spree be­gan in Jan­u­ary and, af­ter a brief in­ter­lude when the pan­dem­ic first hit the US and Eu­rope, has on­ly picked up in the last two months. The 23 com­pa­nies that have gone pub­lic av­er­aged an 80% re­turn on their of­fer­ing price, ac­cord­ing to Re­nais­sance Cap­i­tal num­bers. Every sin­gle one priced above their mid­point or up­sized their of­fer­ing.

Un­like most of their fel­low new­ly or would-be pub­lic biotechs, Berke­ley Lights will en­ter the mar­ket with sig­nif­i­cant rev­enue on the books. The com­pa­ny doesn’t make drugs but in­stead has built a “dig­i­tal cell bi­ol­o­gy” plat­form that can an­a­lyze liv­ing cells from a va­ri­ety of dif­fer­ent di­men­sions and, in prin­ci­pal, ac­cel­er­ate drug de­vel­op­ment. They’ve part­nered with Sanofi and Pfiz­er on an­ti­body dis­cov­ery and last year, signed a $150 mil­lion pact with Gink­go Bioworks to help the syn­thet­ic bi­ol­o­gy uni­corn ad­vance its ge­net­ic en­gi­neer­ing ca­pa­bil­i­ties.

All told, the com­pa­ny earned $51 mil­lion in rev­enue last year. Un­like a drug de­vel­op­er, they have no cash ear­marked for spe­cif­ic pipeline prod­ucts, and said they will use pro­ceeds for re­search, po­ten­tial ac­qui­si­tions and “gen­er­al cor­po­rate pur­pos­es.”

For ALX On­col­o­gy, a suc­cess­ful of­fer­ing would mean their sec­ond $100 mil­lion tranche of the year. In Feb­ru­ary, the Cal­i­for­nia biotech raised $105 mil­lion to help ad­vance its sole pipeline can­di­date: an an­ti­body de­signed to tar­get CD47. That’s the same “don’t-eat-me” sig­nal tar­get­ed by Irv Weiss­man’s Forty Sev­en Inc., the biotech Gilead paid $5 bil­lion for in Jan­u­ary. ALX’s pitch is that their an­ti­body’s FC re­cep­tor is en­gi­neered to not at­tract macrophages, re­duc­ing tox­i­c­i­ty. The biotech will use their pro­ceeds to push the drug through its on­go­ing head and neck squa­mous cell car­ci­no­ma and gas­tric can­cer tri­al and be­gin new tri­als for it in acute myeloid leukemia and myelodys­plas­tic syn­drome. A por­tion is al­so ear­marked for CMC work.

Found­ed out of Po­laris in 2018, Pan­dion Ther­a­peu­tics was tapped last year for an up-to $800 mil­lion part­ner­ship to help a re­or­ga­niz­ing Astel­las de­vel­op an­ti­bod­ies for au­to-im­mune dis­or­ders. That deal in­clud­ed $45 mil­lion up­front and the com­pa­ny al­so earned $80 mil­lion from a Se­ries B in April. The new fund­ing will be used to push their lead mol­e­cule through Phase I/II tri­als in ul­cer­a­tive col­i­tis while al­so back­ing pre­clin­i­cal re­search, par­tic­u­lar­ly on a pair of an­ti­bod­ies meant to turn on the PD-1 check­point and tamp down the im­mune sys­tem.

Kiromic, mean­while, is in part just try­ing to stay alive. With less than $2 mil­lion — $5 mil­lion when a sub­se­quent $3 mil­lion Se­ries B is in­clud­ed — in the bank at year’s end, they ac­knowl­edged in their S-1 that there’s “sub­stan­tial doubt re­gard­ing the Com­pa­ny’s abil­i­ty to con­tin­ue as a go­ing con­cern.” In this cli­mate, though, that’s worked out just fine for oth­er com­pa­nies. Ap­plied Mol­e­c­u­lar Trans­port went pub­lic in May with the same con­cerns. They ul­ti­mate­ly raised $177 mil­lion.

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

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Pascal Soriot (AP Images)

As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Overnight for­tunes are be­ing made in biotech these days — and it's both en­cour­ag­ing and more than a lit­tle bit scary

Just to complete the last leg of a running story I’ve been tracking for a few weeks, Olema $OLMA has come through its IPO from the Thursday night pricing at $19 a share with a market cap just north of $2 billion.

That leaves newly-named CEO Sean Bohen holding a batch of 1,110,896 shares with a strike price of $4.82. As of Tuesday morning, the stock is now trading at $53.40, giving him a portfolio value of $53.4 million. Not bad for someone who was hired in September.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

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John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

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