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 CD-47. 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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.