Af­ter a slow week, the IPO train is back up and run­ning as 3 more biotechs hop aboard

Af­ter the IPO mar­ket cooled off last week — not just in phar­ma but the en­tire mar­ket, which saw on­ly one pub­lic de­but ac­cord­ing to Re­nais­sance Cap­i­tal — three more biotechs filed their S-1 pa­per­work Fri­day.

The new en­trants are Prometheus Bio­sciences, Long­board Phar­ma­ceu­ti­cals and Gain Ther­a­peu­tics. Prometheus is pen­cil­ing in the high­est raise of the group, es­ti­mat­ing a $125 mil­lion in­flux of cash. Long­board is seek­ing $86 mil­lion, while Gain is look­ing to raise $40 mil­lion.

There have been 16 biotechs to de­but on Nas­daq so far this year, with Sana lead­ing the way. Its mas­sive IPO raise, which was up­dat­ed to more than $675 mil­lion af­ter the un­der­writ­ers ex­er­cised all their op­tions, makes up the li­on’s share of a com­bined $2.86 bil­lion fundraise.

Here’s what these biotechs have in store for Nas­daq:

Prometheus looks to make use of the biotech IPO fire

Just a few months af­ter a $130 mil­lion crossover round, Prometheus is mak­ing the jump to the pub­lic mar­ket.

Spun out of Cedars-Sinai Med­ical Cen­ter, the com­pa­ny built a con­sid­er­able por­tion of its sci­en­tif­ic foun­da­tion around the work of Stephan Tar­gan, an IBD spe­cial­ist who found­ed the IBD Cen­ter at the med­ical cen­ter about 30 years ago. Their lead pro­gram, PRA023, is an an­ti-TL1A an­ti­body. Pfiz­er has a sim­i­lar pro­gram, but CEO Mark McKen­na has am­bi­tions to build a broad pipeline around IBD.

That crossover stretched Prometheus’ run­way out to 2023, when McKen­na hopes to have three to four pro­grams ei­ther IND-ready or in the clin­ic.

In the ini­tial S-1, Prometheus is look­ing to fund de­vel­op­ment for PRA023 in ul­cer­a­tive col­i­tis and Crohn’s dis­ease, as well as their PR600 pro­gram — an an­ti-TNF an­ti­body slat­ed right now as an IBD catch-all. McKen­na hopes to com­plete a Phase II tri­al for the lead can­di­date and wrap up IND-en­abling stud­ies for PR600.

Al­so in­clud­ed in the S-1 was a $1 mil­lion bonus for McKen­na, should he com­plete the IPO raise by March 9. That comes on top of an in­dus­try-stan­dard $500,000 salary last year with $750,000 col­lect­ed in per­for­mance bonus­es.

Long­board heads to Nas­daq four months af­ter spin­ning out

Long­board is mak­ing the quick tran­si­tion to a pub­lic com­pa­ny just a few months af­ter spin­ning out as its own com­pa­ny.

A for­mer neu­ro sub­sidiary of Are­na Phar­ma, Long­board came to life in Oc­to­ber with $56 mil­lion in fund­ing. The biotech was orig­i­nal­ly the brain­child of Are­na CEO Amit Mun­shi, who ar­rived at JP Mor­gan in 2020 with am­bi­tious plans, in­clud­ing launch­ing this sub­sidiary.

The com­pa­ny has three key pro­grams in its pipeline, start­ing with LP352, a “next-gen­er­a­tion,” clin­i­cal stage 5-HT2C ag­o­nist. It’s in de­vel­op­ment for de­vel­op­men­tal and epilep­tic en­cephalopathies, and the S-1 says Long­board wants to use the IPO funds to com­plete a planned Phase Ib/IIa tri­al in this space.

Fol­low­ing up is LP143, an ag­o­nist of the cannabi­noid type 2 re­cep­tor, and LP659, an S1P re­cep­tor mod­u­la­tor. Those two drugs are tar­get­ed at mi­croglial neu­roin­flam­ma­to­ry dis­eases. Long­board is seek­ing to com­plete Phase I tri­als for both pro­grams with the IPO mon­ey, per the S-1.

For­mer CFO Kevin Lind was ap­point­ed as the new CEO back in Oc­to­ber.

Gain to go pub­lic with a mod­est $40 mil­lion raise es­ti­mate

Seek­ing the small­est raise of the group, Gain is aim­ing for a rel­a­tive­ly mod­est $40 mil­lion raise giv­en the run of biotechs over the last year or so to seek hefty IPO cash.

Gain fo­cus­es on pro­tein mis­fold­ing, with an ini­tial goal of treat­ing lyso­so­mal stor­age dis­or­ders. They have ex­clu­sive­ly in-li­censed a pro­pri­etary plat­form to ac­com­plish this, and are tar­get­ing the GLB1 gene to cre­ate ther­a­pies for GM1 gan­gliosi­do­sis and the GBA1 Gauch­er’s dis­ease and Parkin­son’s.

It’s here where Gain will fun­nel its IPO funds, with the hope of push­ing these can­di­dates in­to Phase I/II tri­als for their re­spec­tive in­di­ca­tions. The com­pa­ny al­so has can­di­dates that try to hone in on the ID­UA gene in mu­copolysac­cha­ri­do­sis type 1 and the GALC gene in Krabbe dis­ease.

Gain emerged from stealth last Ju­ly with a $10 mil­lion Se­ries B round, us­ing that fundraise to set up two IND-en­abling stud­ies.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

In­tro­duc­ing End­pointsF­DA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.