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

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.