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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is wide open.

First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Eli Lilly CSO Dan Skovronsky (file photo)

UP­DAT­ED: #ES­MO20: Eli Lil­ly shows off the da­ta for its Verzenio suc­cess. Was it worth $18 bil­lion?

The press release alone, devoid of any number except for the size of the trial, added nearly $20 billion to Eli Lilly’s market cap back in June. Now investors and oncologists will get to see if the data live up to the hype.

On Sunday at ESMO, Eli Lilly announced the full results for its Phase III MonarchE trial of Verzenio, showing that across over 5,000 women who had had HR+, HER2- breast cancer, the drug reduced the odds of recurrence by 25%. That meant 7.8% of the patients on the drug arm saw their cancers return within 2 years, compared with 11.3% on the placebo arm.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.