The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq

Af­ter a record year for biotech IPOs in 2020, fore­casts were bull­ish on an­oth­er strong year show­ing for pub­lic of­fer­ings — and 2021 hasn’t dis­ap­point­ed so far. Now, a clutch of four biotechs chas­ing rare dis­ease and can­cer and a New York SPAC are ready to join the par­ty.

Three more com­pa­nies filed to head to Nas­daq on Tues­day, as well as a SPAC, with an ad­di­tion­al Dutch biotech fil­ing Fri­day. All in all, ear­ly days in­di­cate an­oth­er big year, at least to start, with 12 com­pa­nies ei­ther pric­ing or fil­ing their IPOs in the first 20 days of Jan­u­ary.

Biotech still has a long way to go to reach the chart-top­ping 81 IPOs record­ed last year and $13.5 bil­lion raised. But here are the newest com­pa­nies help­ing get the in­dus­try off to a hot start.

Chi­na’s Ada­gene looks to in­dex new HERV-based CAR-T

A lit­tle over a week af­ter dis­cov­er­ing a new CAR-T can­di­date, the Chi­nese biotech Ada­gene is shoot­ing to go pub­lic.

Ada­gene’s CAR-T for re­nal cell car­ci­no­ma is the first the biotech’s aware of to tar­get a hu­man en­doge­nous retro­virus ex­pressed in the ma­jor­i­ty of clear-cell kid­ney tu­mors. And on the back of more than $150 mil­lion in fundrais­ing, in­clud­ing a $69 mil­lion Se­ries D last Jan­u­ary, Ada­gene is pen­cil­ing in $125 mil­lion for their IPO raise.

Ada­gene’s can­di­date was de­vel­oped in tan­dem with the NHLBI in the lab of Richard Childs, chief of the Lab­o­ra­to­ry of Trans­plan­ta­tion Im­munother­a­py. The NIH is ex­pect­ed to take over man­u­fac­tur­ing and clin­i­cal de­vel­op­ment.

Re­gard­less of how much cash it ends up rais­ing, Ada­gene said in its S-1 it plans to al­lo­cate 95% of funds to R&D. The com­pa­ny will di­rect 26% of funds to­ward its lead can­di­date, ADG106, a mon­o­clon­al an­ti­body and CD137 ag­o­nist, which is cur­rent­ly in Phase Ib/IIa tri­als for ad­vanced or metasta­t­ic sol­id tu­mors and/or re­lapsed/re­frac­to­ry non-Hodgkin’s lym­phoma.

An­oth­er 26% of funds are slat­ed to go to­ward Ada­gene’s oth­er two pro­grams, ADG116 and ADG126. Both pro­grams seek to block the known can­cer tar­get CT­LA-4, with ADG116 fo­cus­ing on a “unique” epi­tope. The for­mer has start­ed a Phase I in ad­vanced metasta­t­ic sol­id tu­mors while the lat­ter hasn’t yet hit the clin­ic.

Bris­tol My­ers Squibb, which pi­o­neered the first and on­ly CT­LA-4 in­hibitor Yer­voy, al­so tried de­vel­op­ing a 4-1BB ag­o­nist an­ti­body dubbed ure­lum­ab, but hopes for a monother­a­py were dashed af­ter liv­er tox­i­c­i­ties emerged.

The last 43% al­lo­cat­ed to R&D will help fund pre­clin­i­cal can­di­dates and fur­ther plat­form de­vel­op­ment, Ada­gene said. — Max Gel­man

Phar­varis pen­cils in $100 mil­lion raise to back oral HAE ap­proach

A cou­ple months af­ter nab­bing $80 mil­lion in ven­ture cash, Nether­lands-based Phar­varis has pen­ciled in a $100 mil­lion jump on­to Nas­daq to back its up­start ap­proach for the rare ge­net­ic con­di­tion hered­i­tary an­gioede­ma (HAE).

Phar­varis’ lead pro­gram, an in­hibitor and se­lec­tive small-mol­e­cule bradykinin B2-re­cep­tor an­tag­o­nist, is in de­vel­op­ment as an oral al­ter­na­tive to cur­rent­ly avail­able HAE treat­ments — like CSL’s Hae­gar­da and Take­da’s Cin­ryze, Takhzy­ro and Fi­razyr, which are all in­jectable.

“We de­signed PHA121 to im­prove up­on the ther­a­peu­tic pro­file of ex­ist­ing ther­a­pies and, through oral de­liv­ery, to pro­vide pa­tients with qual­i­ty of life and con­ve­nience that is su­pe­ri­or to cur­rent stan­dard-of-care HAE treat­ments, which are in­jecta­bles,” the F-1 states.

The biotech was found­ed by Berndt Modig, now CEO, and a cast of vet­er­ans from Jeri­ni, the biotech that orig­i­nal­ly de­vel­oped Fi­razyr. Back in No­vem­ber, the com­pa­ny re­leased Phase I da­ta from 16 healthy vol­un­teers it said sug­gest their mol­e­cule is 24 times more po­tent than Fi­razyr.

HAE is char­ac­ter­ized by painful swelling in hands, feet and oc­ca­sion­al­ly in the air­ways or in­testi­nal walls.  At­tacks are un­pre­dictable, and have mul­ti­ple trig­gers. Pa­tients ex­pe­ri­ence a me­di­an of 14 at­tacks per year, and half ex­pe­ri­ence po­ten­tial­ly life-threat­en­ing air­way at­tacks at least once in their life­time, Phar­varis said, cit­ing sci­en­tif­ic pub­li­ca­tions.

The com­pa­ny is launch­ing two Phase II tri­als, one for pro­phy­lax­is and one for treat­ing acute pain. If those are suc­cess­ful, they’ll fol­low up with piv­otal Phase III stud­ies. They plan on read­ing out Phase II da­ta for the acute pa­tients in 2022.

Viking Glob­al In­vestors and Gen­er­al At­lantic, which led the Se­ries C, hold just over 6.03% of shares each, ac­cord­ing to the F-1. Modig has a 5.27% stake. — Nicole De­Feud­is 

On the heels of ASH, Nex­Im­mune guns for $86 mil­lion IPO raise

Nex­Im­mune has main­tained a rel­a­tive­ly low pro­file af­ter com­plet­ing its $23 mil­lion Se­ries A way back in 2018. But now the Gaithers­burg, MD-based biotech has two pro­grams in the clin­ic and plans to go pub­lic with an es­ti­mat­ed $86 mil­lion raise.

The com­pa­ny was spun out of Johns Hop­kins and cen­ters around the idea of spe­cial­ized nanopar­ti­cles that act as anti­gen-pre­sent­ing cells to in­cite a T cell at­tack on tu­mors. Nex­Im­mune’s ul­ti­mate goal is to pro­vide a more durable at­tack in­volv­ing 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.

With­in its S-1, Nex­Im­mune said the IPO funds will go to­ward its two lead pro­grams, NEXI-001 and NEXI-002 that fo­cus on donor-de­rived and pa­tient-de­rived T cells, re­spec­tive­ly.

NEXI-001 is in an on­go­ing Phase I/II study in acute myeloid leukemia, with ini­tial re­sults pre­sent­ed last month at ASH. Among the two dozen or so pa­tients, the can­di­date was shown to in­duce a re­turn to base­line lev­els of ab­solute lym­pho­cyte counts with­in 3 to 35 days. The pro­gram is still in its ear­ly clin­i­cal days, how­ev­er.

There haven’t been any read­outs for NEXI-002 yet, but Nex­Im­mune dosed the first pa­tient in a Phase I/II study in mul­ti­ple myelo­ma last Oc­to­ber. — Max Gel­man

Bio­phytis takes a sec­ond shot at a Nas­daq de­but

Sec­ond time’s the charm for Bio­phytis. The French biotech pre­vi­ous­ly filed an F-1 back in May 2019, pen­cil­ing in a $15 mil­lion hop on­to Nas­daq. But it with­drew lat­er that Ju­ly due to “un­fa­vor­able mar­ket con­di­tions.”

Now, as the 2021 IPO queue be­gins to take shape, Bio­phytis is back — pen­cil­ing in an­oth­er $15 mil­lion raise for its Nas­daq de­but.

If suc­cess­ful this time around, Bio­phytis plans on fun­nel­ing most of the IPO funds in­to its lead pro­gram: a small mol­e­cule dubbed Sar­co­neos, which the biotech be­lieves can treat sar­cope­nia, Duchenne Mus­cu­lar Dy­s­tro­phy (DMD), and even SARS-CoV-2 pneu­mo­nia.

Sar­co­neos is de­signed to ac­ti­vate the MAS re­cep­tor in mus­cle cells, a key com­po­nent of the Renin-an­giotensin sys­tem (RAS) — an en­docrine sys­tem known to con­trol things like flu­id bal­ance, blood pres­sure, car­dio­vas­cu­lar func­tion and smooth, car­diac and skele­tal mus­cle me­tab­o­lism. By ac­ti­vat­ing the MAS re­cep­tor, Sar­co­neos trig­gers two down­stream sig­nal­ing path­ways in my­ocytes that are im­paired in mus­cle-wast­ing con­di­tions, ac­cord­ing to Bio­phytis.

The ini­tial tar­get in­di­ca­tion is sar­cope­nia, the age-re­lat­ed de­gen­er­a­tion of skele­tal mus­cle that leads to mus­cle mass strength, bal­ance and the abil­i­ty to stand or walk — and for which there’s no ap­proved treat­ment or wide­ly ac­cept­ed stan­dard of care, Bio­phytis said. The can­di­date is cur­rent­ly in a Phase II study for that in­di­ca­tion, with topline re­sults com­ing in Q2 this year.

The oral drug is al­so in Phase II/III for Covid-19 pa­tients with pneu­mo­nia, with the first in­ter­im analy­sis sched­uled for Q1. If all goes well, Bio­phytis says it could file for emer­gency use with the FDA and EMA in Q2.

“Most peo­ple in­fect­ed with the COVID-19 virus will ex­pe­ri­ence mild to mod­er­ate res­pi­ra­to­ry ill­ness and re­cov­er with­out re­quir­ing spe­cial treat­ment,” the F-1 states. Bio­phytis is look­ing to help “old­er peo­ple, and those with un­der­ly­ing med­ical prob­lems like car­dio­vas­cu­lar dis­ease, di­a­betes, chron­ic res­pi­ra­to­ry dis­ease and can­cer,” who are “more like­ly to de­vel­op se­ri­ous ill­ness.”

The com­pa­ny al­so snagged IND ap­proval for a Phase I/II tri­al in DMD last month, and hopes to launch a “seam­less” clin­i­cal tri­al — one that com­bines mul­ti­ple phas­es in­to an adap­tive study — in the first half of 2021, ac­cord­ing to the F-1.

Stanis­las Veil­let, Bio­phytis’ co-founder and CEO who hails from Danone and Mon­san­to, owns 4% of the com­pa­ny’s stock. —Nicole De­Feud­is 

CEO of small NYC biotech heads up $50 mil­lion SPAC 

A new SPAC has emerged, and it’s be­ing led by the CEO of a small New York City biotech.

The blank check com­pa­ny is called FoxWayne En­ter­pris­es Ac­qui­si­tion and seeks to re­verse merge with a com­pa­ny fol­low­ing a $50 mil­lion raise. Robb Knie, CEO of Hoth Ther­a­peu­tics, is lead­ing the charge by of­fer­ing 5 mil­lion shares at $10 apiece.

FoxWayne orig­i­nal­ly filed its S-1 back in De­cem­ber and sub­mit­ted its 8-A last week. The fil­ings were ac­cept­ed Tues­day. — Max Gel­man

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

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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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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.