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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Jason Kelly (Photographer: Kyle Grillot/Bloomberg via Getty Images)

Gink­go nabs $DNA, biotech's most sought af­ter tick­er, for free in sweet­en­er from NYSE

When Ginkgo went comparison shopping for a financial market to list their now $15 billion company, the New York Stock Exchange had a back-pocket sweetener the Nasdaq couldn’t offer: The most sought-after ticker in biotech, $DNA.

DNA — the most famous three letters in biology and the ticker for the world’s first biotech, Genentech, from 1999 until it was bought out by Roche for $48 billion in 2009 — will now be the ticker for Ginkgo, a 12-year-old synthetic biology startup with grand ambitions to change not only how drugs, but also everyday products like meat and perfumes, are made.

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Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another day, another SPAC vying for a spot on Nasdaq.

On Wednesday, OncoSec Medical CEO Daniel O’Connor filed the S-1 paperwork for a new blank-check company he’s leading called Larkspur Health Acquisition. The former Advaxis chief penciled in a $75 million raise, with plans to offer 7.5 million shares at $10 apiece.

BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.