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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.