IPO track­er: Af­ter an­oth­er three pric­ings bring to­tal raise close to $3B, de­buts ex­pect­ed to slow in short week

The End­points News team is con­tin­u­ing to track IPO fil­ings for 2021, and we’re off to an­oth­er hot start af­ter 2020’s record year.

There have al­ready been 16 biotechs to de­but on the Nas­daq so far this year, with Sana lead­ing the way. Its mas­sive IPO raise, which was up­dat­ed to more than $675 mil­lion af­ter the un­der­writ­ers ex­er­cised all their op­tions, makes up the li­on’s share of a com­bined $2.86 bil­lion fundraise.

Cou­pled with the more than $700 mil­lion it raised while pri­vate, Sana went pub­lic with one of the largest val­u­a­tions in the in­dus­try’s his­to­ry and the largest-ever — $4.6 bil­lion — for a com­pa­ny with­out any drugs yet to reach the clin­ic. Five oth­er biotechs have al­so raised more than $200 mil­lion each, how­ev­er, with Gra­cell, Cul­li­nan, Bolt, Im­muno­core and Vor all top­ping the mark.

Three more com­pa­nies tum­bled on­to the mar­ket last week, with Nex­Im­mune, Deci­bel and Bio­phytis all tak­ing the leap. But while an­oth­er small com­pa­ny filed its F-1 last Thurs­day — Pro­ta­genic Ther­a­peu­tics, seek­ing an $18 mil­lion raise — there aren’t any ex­pect­ed pric­ings slat­ed for this week.

That be­ing said, we’ll still be keep­ing an eye on any com­pa­nies who file their S-1s this week. Be­low, you’ll find the com­pa­nies that have filed to go pub­lic, in ad­di­tion to those that have al­ready priced.

THE PITCH: THE S-1s THAT HAVE BEEN FILED

Garo Ar­men

Pro­ta­genic Ther­a­peu­tics

Chair­man: Garo Ar­men
Tick­er: $PTIX
Filed: 2/11/2021
Es­ti­mat­ed raise: $18 mil­lion

Snap­shot: The small neu­ro dis­or­der biotech Pro­ta­genic Ther­a­peu­tics filed for an $18 mil­lion IPO last Thurs­day. Work­ing on neu­ropep­tides de­rived from the TCAP fam­i­ly, the com­pa­ny’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 $4.15 as of Feb. 12.

Mark McKen­na

Prometheus Bio­sciences

CEO: Mark McKen­na
Tick­er: $RXDX
Filed: 2/19/2021
Es­ti­mat­ed raise: $125 mil­lion

Snap­shot: Just a few months af­ter a $130 mil­lion crossover round, Prometheus is mak­ing the jump to the pub­lic mar­ket. Spun out of Cedars-Sinai Med­ical Cen­ter, the com­pa­ny built a con­sid­er­able por­tion of its sci­en­tif­ic foun­da­tion around the work of Stephan Tar­gan, an IBD spe­cial­ist who found­ed the IBD Cen­ter at the med­ical cen­ter about 30 years ago. Their lead pro­gram, PRA023, is an an­ti-TL1A an­ti­body. Pfiz­er has a sim­i­lar pro­gram, but McKen­na has am­bi­tions to build a broad pipeline around IBD. The crossover stretched Prometheus’ run­way out to 2023, when McKen­na hopes to have three to four pro­grams ei­ther IND-ready or in the clin­ic. In the ini­tial S-1, Prometheus is look­ing to fund de­vel­op­ment for PRA023 in ul­cer­a­tive col­i­tis and Crohn’s dis­ease, as well as their PR600 pro­gram — an an­ti-TNF an­ti­body slat­ed right now as an IBD catch-all. McKen­na hopes to com­plete a Phase II tri­al for the lead can­di­date and wrap up IND-en­abling stud­ies for PR600. Al­so in­clud­ed in the S-1 was a $1 mil­lion bonus for McKen­na should he com­plete the IPO raise by March 9. That comes on top of an in­dus­try-stan­dard $500,000 salary last year with $750,000 col­lect­ed in per­for­mance bonus­es.

Kevin Lind

Long­board Phar­ma­ceu­ti­cals

CEO: Kevin Lind
Tick­er: $LBPH
Filed: 2/19/2021
Es­ti­mat­ed raise: $86 mil­lion

Snap­shot: Long­board is mak­ing the quick tran­si­tion to a pub­lic com­pa­ny just a few months af­ter spin­ning out as its own com­pa­ny. A for­mer neu­ro sub­sidiary of Are­na Phar­ma, Long­board came to life in Oc­to­ber with $56 mil­lion in fund­ing. The biotech was orig­i­nal­ly the brain­child of Are­na CEO Amit Mun­shi, who ar­rived at JP Mor­gan in 2020 with am­bi­tious plans, in­clud­ing launch­ing this sub­sidiary. The com­pa­ny has three key pro­grams in its pipeline, start­ing with LP352, a “next-gen­er­a­tion,” clin­i­cal stage 5-HT2C ag­o­nist. It’s in de­vel­op­ment for de­vel­op­men­tal and epilep­tic en­cephalopathies, and the S-1 says Long­board wants to use the IPO funds to com­plete a planned Phase Ib/IIa tri­al in this space. Fol­low­ing up is LP143, an ag­o­nist of the cannabi­noid type 2 re­cep­tor, and LP659, an S1P re­cep­tor mod­u­la­tor. Those two drugs are tar­get­ed at mi­croglial neu­roin­flam­ma­to­ry dis­eases. Long­board is seek­ing to com­plete Phase I tri­als for both pro­grams with the IPO mon­ey, per the S-1. For­mer CFO Kevin Lind was ap­point­ed as the new CEO back in Oc­to­ber.

Er­ic Rich­man

Gain Ther­a­peu­tics

CEO: Er­ic Rich­man
Tick­er: $GANX
Filed: 2/19/2021
Es­ti­mat­ed raise: $40 mil­lion

Snap­shot: Seek­ing a rel­a­tive­ly mod­est raise giv­en the run of biotechs over the last year or so to go af­ter hefty IPO cash, Gain is shoot­ing for just $40 mil­lion. The com­pa­ny fo­cus­es on pro­tein mis­fold­ing, with an ini­tial goal of treat­ing lyso­so­mal stor­age dis­or­ders. They have ex­clu­sive­ly in-li­censed a pro­pri­etary plat­form to ac­com­plish this, and are tar­get­ing the GLB1 gene to cre­ate ther­a­pies for GM1 gan­gliosi­do­sis and the GBA1 for Gauch­er’s dis­ease and Parkin­son’s. It’s here where Gain will fun­nel its IPO funds, with the hope of push­ing these can­di­dates in­to Phase I/II tri­als for their re­spec­tive in­di­ca­tions. The com­pa­ny al­so has can­di­dates that try to hone in on the ID­UA gene in mu­copolysac­cha­ri­do­sis type 1 and the GALC gene in Krabbe dis­ease. Gain emerged from stealth last Ju­ly with a $10 mil­lion Se­ries B round, us­ing that fundraise to set up two IND-en­abling stud­ies.

THE PRICE: COM­PLET­ED IPOs

Wei William Cao

1. Gra­cell Biotech­nolo­gies

CEO: Wei William Cao
Tick­er: $GR­CL
Date: 1/8/2021
Priced: $19
Raised: $209 mil­lion

Snap­shot: The first biotech IPO of 2021, Gra­cell is mov­ing a CAR-T ther­a­py orig­i­nat­ing from Chi­na in­to the pub­lic eye. Gra­cell was built on two tech­nolo­gies: FasT­CAR, which promis­es to short­en man­u­fac­tur­ing turn­around time to 22-36 hours; and Tru­U­CAR, its take on al­lo­gene­ic CAR-T. Ad­di­tion­al­ly, the com­pa­ny has its own pro­duc­tion site in Suzhou to keep the key process­es in-house. In its F-1 fil­ing, Gra­cell re­port­ed that GC012F, its au­tol­o­gous CAR-T ther­a­py tar­get­ing both BC­MA and CD19, has treat­ed 16 pa­tients with re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma, and that 15 achieved and main­tained a re­sponse. The high­est dose co­hort record­ed a 100% strin­gent com­plete re­sponse rate for the six evalu­able pa­tients. Though it faces tough com­pe­ti­tion from well-fund­ed US com­pa­nies like Al­lo­gene, Lyell and even Sana, Gra­cell is plung­ing full speed ahead with a reg­is­tra­tional tri­al in Chi­na that just got cleared and plans to start US tri­als in 2021.

Owen Hugh­es

2. Cul­li­nan On­col­o­gy

CEO: Owen Hugh­es
Tick­er: $CGEM
Date: 1/8/2021
Priced: $21
Raised: $249.9 mil­lion

Snap­shot: Cul­li­nan in­vestors aren’t buy­ing in­to a sin­gle drug or plat­form, but in­stead a sort of um­brel­la with sev­er­al dif­fer­ent hot ap­proach­es to fight­ing can­cer. The com­pa­ny works with a hub-and-spoke mod­el much like Bridge­Bio, re­serv­ing in­di­vid­ual as­sets in sep­a­rate en­ti­ties op­er­at­ing un­der the flag­ship. That way, ex­ecs can cen­tral­ize R&D, BD and ad­min­is­tra­tive work while bet­ting on as many dif­fer­ent ap­proach­es as pos­si­ble. Cul­li­nan has nine such projects un­der the um­brel­la, with the most re­cent pro­gram, known as Cul­li­nan Am­ber an­nounced last Ju­ly. The whole op­er­a­tion’s first drug in the clin­ic is CLN-081 and the on­ly tar­get­ed ther­a­py in the mix, tar­get­ing NSCLC with EGFR ex­on 20 in­ser­tion mu­ta­tions. Oth­er tech ap­proach­es rep­re­sent­ed in­clude bis­pecifics, NK cell-en­gag­ing an­ti­bod­ies, cy­tokine fu­sion pro­tein, as well as TCR-based ther­a­py. Cul­li­nan filed for its IPO short­ly af­ter pre­sent­ing what they called ini­tial clin­i­cal da­ta on CLN-081, and on the heels of an­nounc­ing a $131 mil­lion Se­ries C.

Steve Harr

3. Sana Biotech­nol­o­gy

CEO: Steve Harr
Tick­er: $SANA
Date: 2/3/2021
Priced: $25
Raised: $675.6 mil­lion

Snap­shot: Harr’s team at Sana orig­i­nal­ly pen­ciled in a $150 mil­lion raise, but they end­ed up with a much big­ger fig­ure, re­sult­ing in a rough­ly $4.6 bil­lion val­u­a­tion. Sana al­so sold all of its avail­able op­tions, tak­ing its to­tal raise about $90 mil­lion high­er than when it first priced. That scale, which marked the high­est mar­ket cap in his­to­ry for a biotech with­out any pro­grams in the clin­ic, has drawn com­par­isons to an­oth­er Flag­ship start­up in Mod­er­na, which de­buted at a $7.5 bil­lion val­u­a­tion and has soared on the backs of its Covid-19 vac­cine to reach north of $50 bil­lion. Sana’s lofty raise is based sole­ly on the com­pa­ny’s an­i­mal da­ta and the track records of its in­vestors. As laid out in its S-1, Sana’s long-term goals are “to con­trol or mod­i­fy any gene in the body, to re­place any cell that is dam­aged or miss­ing, and to marked­ly im­prove ac­cess to cel­lu­lar and gene-based med­i­cines.” The com­pa­ny ex­pects to file its first INDs in 2022 and 2023 and is re­search­ing a range of in­di­ca­tions in in vi­vo and ex vi­vo set­tings, in­clud­ing non-Hodgkin lym­phoma, mul­ti­ple myelo­ma, and Type 1 di­a­betes. Sana has made big win­ners out of Bob Nelsen’s ARCH Ven­tures and Flag­ship, who will com­bine to own 43% of shares af­ter the IPO clos­es. And they’re bank­ing the com­pa­ny turns out to be a suc­cess sto­ry like Mod­er­na — or per­haps some­thing even big­ger. The hype is re­al, as Sana closed up rough­ly 60% in its first day and a half of trad­ing.

Josep Bas­saganya-Ri­era

4. Lan­dos Bio­phar­ma

CEO: Josep Bas­saganya-Ri­era
Tick­er: $LABP
Date: 2/3/2021
Priced: $16
Raised: $100 mil­lion

Snap­shot: The lead com­pa­ny in the port­fo­lio of Chris Garabe­di­an’s fund with Per­cep­tive, Lan­dos did not im­press on its last da­ta dump. And since pric­ing at the mid­point late Wednes­day night, Lan­dos shares have since fall­en about 31% from the IPO. In Jan­u­ary, a Phase II proof-of-con­cept tri­al in its lead com­pound, BT-11, missed on all its pri­ma­ry end­points in IBD de­spite “pos­i­tive” signs it mea­sured up with stan­dard of care. Vir­ginia Tech pro­fes­sor Josep Bas­saganya-Ri­era has stud­ied the path­way known as Lan­thio­n­ine Syn­thetase C-Like 2 (LAN­CL2) for more than a decade, and BT-11 aims to lever­age this re­search. Lan­dos is prepar­ing a Phase III tri­al for lat­er this year, seek­ing to eval­u­ate main­te­nance of clin­i­cal re­mis­sion af­ter a year fol­low­ing the 12-week in­duc­tion pe­ri­od. BT-11 is one of three Lan­dos com­pounds uti­liz­ing this path­way, with lead in­di­ca­tions in ul­cer­a­tive col­i­tis and Crohn’s dis­ease, and Lan­dos al­so has plans for BT-11 in eosinophilic esophagi­tis, pso­ri­a­sis and atopic der­mati­tis. The com­pa­ny has ad­vanced a sec­ond pro­gram in­to the clin­ic in IBD as well, launch­ing a Phase I study of NX-13 last Ju­ly.

John Celebi

5. Sen­sei Bio­ther­a­peu­tics

CEO: John Celebi
Tick­er: $SNSE
Date: 2/3/2021
Priced: $19
Raised: $133 mil­lion

Snap­shot: For­mer­ly known as Panacea, Sen­sei had pen­ciled in a $100 mil­lion raise for their bac­te­rio­phage-based can­cer ther­a­pies and pulled in an up­sized raise. Sen­sei is one of a few play­ers ap­ply­ing the bac­te­rio­phages in the can­cer space, though they’ve been stud­ied for decades. Their lead can­di­date, SNS-301, is be­ing stud­ied in com­bi­na­tion with Mer­ck’s Keytru­da for squa­mous cell car­ci­no­ma of the head and neck. The Phase I/II tri­al had en­rolled 11 pa­tients as of Dec 10, and 7 of the 10 evalu­able pa­tients saw some form of dis­ease con­trol. That in­clud­ed one pa­tient with a par­tial re­sponse and two who achieved long-stand­ing sta­ble dis­ease. Sen­sei ex­pects to read out topline da­ta by the end of 2021, which they hope will pave the way to a reg­is­tra­tion-en­abling tri­al. This IPO push comes just a few months af­ter Sen­sei raised $28.5 mil­lion in what they called a Se­ries AA round. Sen­sei is al­so de­vel­op­ing two pre­clin­i­cal can­di­dates — SNS-401, a po­ten­tial vac­cine cock­tail against Merkel cell car­ci­no­ma; and SNS-VISTA, an an­ti­body-based ther­a­peu­tic. With a mar­ket cap of about $640 mil­lion, Sen­sei shares have ticked up about 30% since pric­ing.

Bahi­ja Jal­lal

6. Im­muno­core

CEO: Bahi­ja Jal­lal
Tick­er: $IM­CR
Date: 2/4/2021
Priced: $26
Raised: $258 mil­lion

Snap­shot: TCR pi­o­neer Im­muno­core, pric­ing above its range with an up­sized $258 mil­lion raise, re­vealed a promis­ing set of piv­otal in­ter­im da­ta for their lead pro­gram tebenta­fusp back in No­vem­ber, and is aim­ing to use the IPO funds to fin­ish a Phase III for the can­di­date in front­line cas­es of metasta­t­ic uveal melanoma. Re­searchers gath­ered 378 pa­tients for the late-stage study, pit­ting the com­pound against in­ves­ti­ga­tors’ choice. There’s no ap­proved ther­a­py for this in­di­ca­tion, so the choice tends to be be­tween Keytru­da or Yer­voy, with some pa­tients opt­ing for dacar­bazine in­stead. At the first planned in­ter­im read­out for the in­tent-to-treat, all-com­ers pa­tient pop­u­la­tion, Im­muno­core reg­is­tered a haz­ard ra­tio of 0.51. Jal­lal told End­points News at the time that not on­ly was this the first pos­i­tive late-stage sur­vival da­ta for a TCR, but al­so the first pos­i­tive Phase III snap­shot for a bi-spe­cif­ic in a sol­id tu­mor, as well as the first such match-up against check­points. The com­pa­ny had pre­vi­ous­ly raised more than $450 mil­lion, in­clud­ing a then-record Eu­ro­pean round of $320 mil­lion for their Se­ries A in 2015. Im­muno­core was al­so the vic­tim of an al­leged “kick­back” fraud in a scheme in­volv­ing two third-par­ty sup­pli­ers, The Times re­port­ed in late Jan­u­ary. The com­pa­ny had al­so ex­pect­ed to raise an ad­di­tion­al $15 mil­lion in pri­vate place­ment from the Bill and Melin­da Gates Foun­da­tion at the same time as the IPO.

Randy Schatz­man

7. Bolt Bio­ther­a­peu­tics

CEO: Randy Schatz­man
Tick­er: $BOLT
Date: 2/4/2021
Priced: $20
Raised: $230 mil­lion

Snap­shot: Bolt had most re­cent­ly raised $93.5 mil­lion in a Se­ries C last Ju­ly and raised an up­sized $230 mil­lion af­ter orig­i­nal­ly ex­pect­ing a range of $16 to $18. The main idea is one that comes from the in­ven­tor of the first can­cer vac­cine, with a lead pro­gram in BDC-1001 they call an im­mune-stim­u­lat­ing an­ti­body con­ju­gate. Where­as the vac­cine process in­volved ex­tract­ing den­drit­ic cells, ex­pos­ing them to a pro­tein from the pa­tients’ own tu­mors and re­in­fus­ing them, Bolt is try­ing to di­rect­ly ac­ti­vate den­drit­ic cells around tu­mors with­out the need for re­moval. If it works, the can­di­date would turn the en­vi­ron­ment around the tu­mor from an im­muno-sup­pres­sive to one that could not on­ly kill the tu­mors once but pre­vent a re­cur­rence. BDC-1001 en­tered a Phase I/II tri­al for pa­tients with HER2-ex­press­ing sol­id tu­mors in the first quar­ter of 2020. It’s cur­rent­ly in a dose-es­ca­la­tion stage, and is ex­pect­ed to move in­to Phase II dose ex­pan­sions this year. Af­ter the first da­ta emerge from that study, the com­pa­ny will move in­to tri­als specif­i­cal­ly for gas­tric and breast can­cer.

Robert Ang

8. Vor Bio­phar­ma

CEO: Robert Ang
Tick­er: $VOR
Filed: 2/4/2021
Priced: $18
Raise: $203.4 mil­lion

Snap­shot: Vor priced at the high end of its range and raised an up­sized $203.4 mil­lion, up from an es­ti­mat­ed $150 mil­lion. That in­cludes the op­tions picked up by un­der­writ­ers af­ter the com­pa­ny priced. The goal for their IPO is to fund two of its pro­grams, VOR33 and VCAR33, that it hopes can work hand in hand. VOR33 is a pro­gram of en­gi­neered hematopoi­et­ic stem cells de­signed to re­place the stan­dard of care in trans­plant set­tings, and once those cells have been en­graft­ed, Vor says pa­tients can be treat­ed with an­ti-CD33 ther­a­pies like VCAR33. Vor cur­rent­ly has plans to start a Phase I/IIa tri­al for VOR33 in acute myeloid leukemia in the first half of this year, with funds from the raise al­so go­ing to­ward pre­clin­i­cal de­vel­op­ment for myelodys­plas­tic/myelo­pro­lif­er­a­tive neo­plasms. For VCAR33, a CD33-di­rect­ed CAR-T cell ther­a­py li­censed from the NIH in No­vem­ber, Vor is seek­ing to fund a Phase I/II tri­al from launch through com­ple­tion in adult AML. The biotech has sig­nif­i­cant back­ing, in­clud­ing a com­bined $152 mil­lion be­tween two fundrais­ing rounds with both co-led by RA Cap­i­tal. Vor was found­ed by Co­lum­bia on­col­o­gist and Pulitzer Prize-win­ning au­thor Sid­dhartha Mukher­jee, who chron­i­cled the promise and price of the first gen­er­a­tion of CAR-T ther­a­pies for the New York­er.

Senthil Sun­daram

9. Terns Phar­ma­ceu­ti­cals

CEO: Senthil Sun­daram
Tick­er: $TERN
Date: 2/4/2021
Priced: $17
Es­ti­mat­ed raise: $128 mil­lion

Snap­shot: Terns pulled in an $87.5 mil­lion Se­ries C ear­li­er in Jan­u­ary but is now aim­ing to take ad­van­tage of the hot NASH mar­ket by go­ing pub­lic, pric­ing at the high end of its range and rais­ing an up­sized $128 mil­lion. The com­pa­ny has seen a sharp rise since be­ing found­ed with the help of Eli Lil­ly, which pro­vid­ed seed fund­ing and li­censed the com­pa­ny’s three NASH can­di­dates, back in 2018. Terns has sent two of those pro­grams to the clin­ic and is aim­ing to main­ly fund a Phase IIa tri­al for lead can­di­date TERN-101 through com­ple­tion. The pro­gram is ex­pect­ed to pro­duce topline Phase IIa da­ta in the sec­ond half of 2021 and is a liv­er-di­rect­ed non-bile acid far­ne­soid X re­cep­tor (FXR) ag­o­nist be­ing test­ed on 96 pa­tients. While Terns faces com­pe­ti­tion from oth­er NASH play­ers like In­ter­cept and Ab­b­Vie, which snagged an FXR ag­o­nist in the Al­ler­gan buy­out, the com­pa­ny thinks its can­di­date’s safe­ty pro­file is where it will stand out. Terns’ S-1 al­so de­tailed plans to com­plete a Phase I study and launch Phase II de­vel­op­ment for the pro­gram TERN-501, and to ad­vance a third pro­gram TERN-201 through Phase Ib.

Berndt Modig

10. Phar­varis

CEO: Berndt Modig
Tick­er: $PHVS
Date: 2/4/2021
Priced: $20
Es­ti­mat­ed raise: $165 mil­lion

Snap­shot: Phar­varis is head­ing to the Nas­daq af­ter rais­ing an $80 mil­lion Se­ries C back in No­vem­ber, pric­ing above its range with an up­sized $165 mil­lion raise. Their lead pro­gram, an in­hibitor and se­lec­tive small-mol­e­cule bradykinin B2-re­cep­tor an­tag­o­nist, is in de­vel­op­ment as an oral al­ter­na­tive to cur­rent­ly avail­able HAE treat­ments. Those in­clude CSL’s Hae­gar­da, Take­da’s Cin­ryze, Takhzy­ro and Fi­razyr, which are all in­jectable. Modig and his team of vet­er­ans come 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 that drug. Phar­varis is launch­ing two Phase II tri­als, one for pro­phy­lax­is and one for treat­ing acute HAE at­tacks. 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. They are al­so de­vel­op­ing a new for­mu­la­tion that they plan to even­tu­al­ly use in pro­phy­lax­is tri­als. Phar­varis could face chal­lenges, how­ev­er, as oth­er com­pa­nies have strug­gled to de­vel­op oral HAE treat­ments in the past. No­tably, BioCryst saw its shares cut in half last year af­ter Phase III re­sults fell short of in­vestor ex­pec­ta­tions.

Lars Weg­n­er

11. Evax­ion Biotech

CEO: Lars Weg­n­er
Tick­er: $EVAX
Date: 2/4/2021
Priced: $10
Raised: $30 mil­lion

Snap­shot: A Dan­ish com­pa­ny us­ing ar­ti­fi­cial in­tel­li­gence to de­vel­op im­muno-on­col­o­gy ther­a­pies, Evax­ion priced at the low end of its range. The com­pa­ny has four pro­grams it ex­pects to fund us­ing the IPO raise. Its lead pro­gram EVX-01, a per­son­al im­munother­a­py treat­ment based on the in­di­vid­ual pa­tient’s DNA. Re­searchers say they are us­ing an AI plat­form to get the body’s own im­mune sys­tem to find and kill the can­cer tu­mor cells by ap­ply­ing an al­go­rithm to se­lect mu­tat­ed pro­teins most like­ly to gen­er­ate an im­mune re­sponse. Evax­ion says it can de­liv­er the ther­a­py about 7 weeks af­ter tak­ing a pa­tient’s blood sam­ple. A Phase I/IIa read­out in blad­der can­cer, ma­lig­nant melanoma and NSCLC is ex­pect­ed in the first half of 2021. In ad­di­tion to im­muno-on­col­o­gy, Evax­ion is study­ing a vac­cine pro­gram against bac­te­r­i­al dis­eases, called EVX-B1. IPO fund­ing will help this can­di­date get through pre­clin­i­cal and CMC ac­tiv­i­ties and to a hope­ful reg­u­la­to­ry fil­ing in the sec­ond half of 2022.

Jay Venkate­san

12. An­gion Bio­med­ica

CEO: Jay Venkate­san
Tick­er: $ANGN
Date: 2/5/2021
Priced: $16
Raised: $80 mil­lion

Snap­shot: De­vel­op­ing small mol­e­cule ther­a­pies for acute or­gan in­juries, An­gion priced at the high end of its range and raised a slight­ly up­sized $80 mil­lion. Its lead pro­gram, ANG-3777, is cur­rent­ly en­rolling Phase III stud­ies for re­duc­ing the sever­i­ty of de­layed graft func­tion af­ter a kid­ney trans­plant. In an up­dat­ed S-1, the com­pa­ny says it plans to com­mit $15 mil­lion to $25 mil­lion to fund this tri­al as well as prep an NDA for the com­pound. If every­thing goes as planned, da­ta from the tri­al will read out by the end of 2021 with an NDA com­ing next year. ANG-3777 is al­so be­ing stud­ied in acute kid­ney in­jury as­so­ci­at­ed with car­diac surgery, with a Phase II study un­der­way. Some IPO funds will be di­rect­ed to­ward launch­ing a Phase III in this in­di­ca­tion, as well as an­oth­er Phase II study in ARDS re­lat­ed to Covid-19. An­gion has a sec­ond clin­i­cal pro­gram called ANG-3070, which is in a Phase I tri­al for a fi­brot­ic dis­ease. Rough­ly $17 mil­lion to $27 mil­lion will push this Phase I through and launch a Phase II study for the pro­gram. An­gion set its IPO terms on Feb. 1 and ex­pects to price the same week.

Pe­ter Luo

13. Ada­gene

CEO: Pe­ter Luo
Tick­er: $ADAG
Date: 2/9/2021
Priced: $19
Raised: $140 mil­lion

Snap­shot: Ada­gene dis­cov­ered a new CAR-T can­di­date ear­li­er in Jan­u­ary, and sought to cap­i­tal­ize on the mo­ment with an IPO. They suc­ceed­ed, pulling in a raise slight­ly above ex­pec­ta­tions. Their pro­gram for re­nal cell car­ci­no­ma is the first of which the biotech is aware that tar­gets a hu­man en­doge­nous retro­virus ex­pressed in the ma­jor­i­ty of clear-cell kid­ney tu­mors. The CAR-T was de­vel­oped in tan­dem with the NHLBI, and the NIH is ex­pect­ed to take over man­u­fac­tur­ing and clin­i­cal de­vel­op­ment. Ada­gene’s IPO funds are slat­ed to go else­where, with 95% of the raise pen­ciled in for R&D. The ex­ec team will di­rect 26% of funds to­ward its lead can­di­date, ADG106. A mon­o­clon­al an­ti­body and CD137 ag­o­nist, the pro­gram 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. ADG116 has en­tered a Phase I study while ADG126 is still in pre­clin­i­cal stages. The last 43% al­lo­cat­ed to R&D will help fund pre­clin­i­cal can­di­dates and fur­ther plat­form de­vel­op­ment.

14. Bio­phytis

CEO: Stanis­las Veil­let

Stanis­las Veil­let

Tick­er: $BPTS
Date: 2/10/2021
Priced: $16.75
Raised: $20 mil­lion

Snap­shot: Bio­phytis is tak­ing a sec­ond crack at an IPO, hav­ing pre­vi­ous­ly filed an F-1 back in May 2019. The com­pa­ny with­drew its $15 mil­lion pitch lat­er that Ju­ly due to “un­fa­vor­able mar­ket con­di­tions,” but is pen­cil­ing in the same amount for its lat­est at­tempt. If suc­cess­ful this time around, Bio­phytis plans on fun­nel­ing most of the funds in­to its lead pro­gram: a small mol­e­cule dubbed Sar­co­neos, which the biotech be­lieves can treat sar­cope­nia, Duchenne mus­cu­lar dy­s­tro­phy, and pneu­mo­nia re­lat­ed to SARS-CoV-2. The mol­e­cule is de­signed to ac­ti­vate the MAS re­cep­tor in mus­cle cells, a key com­po­nent of the Renin-an­giotensin sys­tem that con­trols things like flu­id bal­ance, blood pres­sure, car­dio­vas­cu­lar func­tion and mus­cu­lar me­tab­o­lism. Sar­co­neos’ ini­tial tar­get in­di­ca­tion, sar­cope­nia, is the age-re­lat­ed de­gen­er­a­tion of skele­tal mus­cle. It’s cur­rent­ly in a Phase II study for sar­cope­nia with topline re­sults com­ing in the sec­ond quar­ter this year, as well as a Phase II/III for Covid-19 pa­tients with pneu­mo­nia. The first in­ter­im analy­sis for that in­di­ca­tion is slat­ed for 2021’s first quar­ter.

15. Deci­bel Ther­a­peu­tics

CEO: Lau­rence Reid

Lau­rence Reid

Tick­er: $DBTX
Date: 2/11/2021
Priced: $18
Raised: $127 mil­lion

Snap­shot: Deci­bel rough­ly dou­bled their cap­i­tal in No­vem­ber af­ter rais­ing $82 mil­lion in a Se­ries D, and now they’ve gone pub­lic just a cou­ple of months lat­er with an up­sized $127 mil­lion raise. The com­pa­ny spent years fo­cused on pre­vent­ing hear­ing loss, but they piv­ot­ed last win­ter. Faced with what they char­ac­ter­ized as sur­pris­ing ad­vance­ments in ge­nom­ic and re­gen­er­a­tive tech­nol­o­gy, and hav­ing failed to find a bio­mark­er that could let them run a pre­ven­ta­tive tri­al, they de­cid­ed to scrap key pro­grams and fo­cus on gene ther­a­pies that can re­store hear­ing loss. De­vel­oped in part­ner­ship with Re­gen­eron, Deci­bel’s gene ther­a­py for the same pro­tein isn’t sched­uled to hit the clin­ic un­til 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. The biotech is one of three Boston-area com­pa­nies chas­ing cures for hear­ing dis­or­ders, next to the well-heeled gene ther­a­py up­start Ak­ou­os and the stem cell re­gen­er­a­tion de­vel­op­ers at Fre­quen­cy Ther­a­peu­tics.

16. Nex­Im­mune

Scott Carmer

CEO: Scott Carmer
Tick­er: $NEXI
Date: 2/12/2021
Priced: $17
Raised: $110 mil­lion

Snap­shot: Spun out of Johns Hop­kins with a $23 mil­lion Se­ries A back in 2018, Nex­Im­mune pulled in a high­er than ex­pect­ed $110 mil­lion range. The com­pa­ny cen­ters around the idea of spe­cial­ized nanopar­ti­cles that act as anti­gen-pre­sent­ing cells to in­cite a T cell at­tack on tu­mors, and had main­tained a rel­a­tive­ly low pro­file af­ter that Se­ries A, but re­searchers pre­sent­ed ini­tial re­sults from a Phase I/II study in its lead pro­gram at ASH last De­cem­ber. That study, for NEXI-001, is eval­u­at­ing pa­tients with acute myeloid leukemia. Among the first five pa­tients dosed, 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, and aims to en­roll be­tween 22 and 28 pa­tients. Nex­Im­mune’s oth­er lead can­di­date NEXI-002 hasn’t yet had a da­ta read­out, but was dosed in the first pa­tient with mul­ti­ple myelo­ma last Oc­to­ber. The com­pa­ny’s ul­ti­mate goal for its mol­e­cules 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. IPO funds will go to­ward both of these pro­grams.

First pub­lished Jan­u­ary 25, 2021.

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.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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René Russo, Xilio CEO (Alicia Petitti for Xilio)

Xilio Ther­a­peu­tics goes pub­lic as bio­phar­ma IPOs rum­ble for­ward in Q4

It’s been a busy fall on Wall Street — and this week, we’ve got another biotech going public after Ventyx yesterday.

Massachusetts solid-tumor biotech Xilio Therapeutics made its public debut today, joining 149 other biotechs that have gone public so far this year.

Back on October 1st, Xilio filed its S-1 with the SEC to make its IPO debut for $100 million — the next step in financing after completing a $95 million Series C back in February.

Luc Boblet, Egle Therapeutics CEO

A new Treg play­er emerges with $46M and back­ing from Take­da

In recent years, the chorus of biotechs and Big Pharma backers targeting regulatory T cells — also known as “Tregs” — for cancer and autoimmune diseases has only grown louder.

The newest voice is from Egle Therapeutics, which sang out a $46.4 million Series A round on Friday led by LSP and Bpifrance through their InnoBio 2 fund. Takeda’s venture arm also chipped in, about a year after the pharma struck a research pact with the Paris-based upstart.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.