A pair of biotechs pre­pares to hit Nas­daq, as to­tal 2021 IPO raise quick­ly ap­proach­es $3B

Af­ter a busy week last week when 10 biotechs went pub­lic, the in­dus­try con­tin­ues to see a steady stream of com­pa­nies mak­ing their de­buts.

With Ada­gene pric­ing ear­li­er this week and two more biotechs join­ing them late Thurs­day in­to ear­ly Fri­day, there have now been 16 com­pa­nies to IPO so far in 2021. The to­tal com­bined raise is rapid­ly ris­ing and ap­proach­ing $3 bil­lion al­ready — biotechs have pulled in rough­ly $2.86 bil­lion thus far.

That growth has large­ly been dri­ven by Sana’s mega IPO, which ac­counts for about one-fourth of the over­all sum. But five oth­er biotechs have al­so raised more than $200 mil­lion each: Gra­cell, Cul­li­nan, Bolt, Im­muno­core and Vor.

Here’s a run­down of the two com­pa­nies that priced af­ter mar­ket close Thurs­day af­ter­noon, as well as an­oth­er biotech that filed its S-1 on Thurs­day night.

Nex­Im­mune de­buts on heels of pos­i­tive ASH re­sults

Spun out of Johns Hop­kins back in 2018, Nex­Im­mune is look­ing to cap­i­tal­ize on strong ASH da­ta from its lead pro­gram.

The biotech priced at $17, the high end of its range, rais­ing $110 mil­lion in the process. It plans to trade on the tick­er $NEXI. Orig­i­nal­ly plan­ning to sell 4.7 mil­lion shares, Nex­Im­mune ul­ti­mate­ly sold 6.5 mil­lion, help­ing it achieve that high end.

Nex­Im­mune cen­ters around the con­cept of spe­cial­ized nanopar­ti­cles that act as anti­gen-pre­sent­ing cells to in­cite a T cell at­tack on tu­mors. Re­searchers pre­sent­ed ini­tial re­sults from a Phase I/II study last De­cem­ber for NEXI-001, show­ing it in­duced a re­turn to base­line lev­els of ab­solute lym­pho­cyte counts with­in three to 35 days among the first five pa­tients dosed.

The pro­gram is still in its ear­ly days, though, and Nex­Im­mune is look­ing to en­roll some­where be­tween 22 and 28 to­tal pa­tients. With­in its S-1, Nex­Im­mune said it plans to steer IPO funds to­ward both this pro­gram and NEXI-002, first dosed in a hu­man last Oc­to­ber in a mul­ti­ple myelo­ma tri­al.

If the com­pa­ny’s tech ends up work­ing, re­searchers say it could spark a more durable at­tack that would in­volve more tar­gets and less like­li­hood of a set­back for pa­tients — par­tic­u­lar­ly if they can make an im­pact on naïve and mem­o­ry T cells to keep the hu­man im­mune sys­tem on alert.

Af­ter piv­ot to gene ther­a­py, Deci­bel moves quick­ly to IPO

Deci­bel Ther­a­peu­tics is mov­ing fast af­ter a Se­ries D just three months ago.

Back in No­vem­ber, the com­pa­ny raised $82 mil­lion in the round, and Thurs­day evening they priced their up­sized IPO. Deci­bel priced at $18 per share, the high end of its range, and pulled in $127 mil­lion. They sold 7.1 mil­lion shares af­ter an­nounc­ing plans to sell 5.9 mil­lion.

When it hits Nas­daq on Fri­day, Deci­bel will trade on the tick­er $DBTX.

Deci­bel had spent years fo­cused on pre­vent­ing hear­ing loss, but they piv­ot­ed last win­ter to gene ther­a­pies that can re­store lost hear­ing. The move came af­ter fail­ing to find a bio­mark­er that could let them run a pre­ven­ta­tive tri­al, as well as what they char­ac­ter­ized as sur­pris­ing ad­vance­ments in ge­nom­ic and re­gen­er­a­tive tech­nol­o­gy.

It’s now one of three ma­jor Boston-area biotechs chas­ing these types of cures, next to the gene ther­a­py out­fit Ak­ou­os and the stem cell re­gen­er­a­tion de­vel­op­ers at Fre­quen­cy Ther­a­peu­tics.

Deci­bel’s first gene ther­a­py was de­vel­oped in col­lab­o­ra­tion with Re­gen­eron, but isn’t sched­uled to hit the clin­ic un­til at least 2022. Re­searchers are start­ing with fix­ing a sin­gle gene in peo­ple with the OTOF mu­ta­tions, but the long-term goal is to build cures for more gen­er­al hear­ing loss and bal­ance dis­or­ders.

Small stress-fo­cused Pro­ta­genic files its $18 mil­lion S-1

On the small­er side of things, neu­ro dis­or­der biotech Pro­ta­genic Ther­a­peu­tics filed for an $18 mil­lion IPO on Thurs­day.

The NY-based biotech is work­ing on neu­ropep­tides de­rived from the TCAP fam­i­ly. Pro­ta­genic’s lead pro­gram, PT00114, is be­ing de­vel­oped to treat stress-re­lat­ed dis­or­ders such as PTSD and drug and al­co­hol ad­dic­tions with­out in­ter­fer­ing with brain func­tion.

The com­pound is ex­pect­ed to com­plete IND-en­abling stud­ies in ear­ly 2021, and sub­se­quent­ly en­ter Phase I/II tri­als. Pro­ta­genic said in its S-1 it plans to fun­nel mon­ey to­ward en­rolling this “bas­ket” tri­al, with the goal of sign­ing up 42 pa­tients.

Ul­ti­mate­ly, Pro­ta­genic’s goal is to im­prove men­tal health by coun­ter­bal­anc­ing stress over­drive and restor­ing the health of neu­ronal cells. Pro­ta­genic is al­ready list­ed on the OTC­QB mar­ket, with se­cu­ri­ties list­ed at $4.14 as of Feb. 2.

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.