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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.

Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Jeffrey Nau, Oyster Point Pharma CEO

FDA OKs an in­haled ver­sion of smok­ing ces­sa­tion drug Chan­tix — for a com­mon eye dis­ease

Oyster Point Pharma now has its first FDA-approved product — Tyrvaya. And the biotech has taken a unique route to get there by using an old drug with a storied past.

The New Jersey biotech announced this morning that the FDA has approved their nasal spray product for dry eye disease on Friday — the first nasal spray to be approved for the disease. The product’s active ingredient is 0.03 mg of varenicline, also known as smoking cessation aid Chantix.