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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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