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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

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Robert Califf (Michael Brochstein/Sipa USA via AP Images)

House Re­pub­li­cans at­tack Chi­na-on­ly da­ta in FDA sub­mis­sions, seek new in­ves­ti­ga­tion in­to re­search in­spec­tions

Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.

The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.

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Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; 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.

It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.

Anthony Fauci (AP Images)

West Vir­ginia man faces prison time for threat­en­ing emails to Fau­ci, oth­er health of­fi­cials

NIAID director Anthony Fauci gained hero status amid the pandemic, earning Americans’ trust and even Time magazine’s Guardian of the Year title. But he and other federal health officials have also faced intense threats, according to charges brought by the US Department of Justice.

A West Virginia man is facing up to 10 years in prison after threatening Fauci, former NIH director Francis Collins, and HHS assistant secretary for health Rachel Levine via email, the DOJ said on Monday. Thomas Patrick Connally, Jr., pleaded guilty on Monday to using an anonymous email address to threaten the officials for performing their official duties, including discussing Covid-19 testing and prevention.