IPO TRACKER

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Less than six months af­ter emerg­ing from stealth, the Deer­field-backed biotech Nu­va­lent is al­ready prep­ping a jump to Nas­daq. It’s a big win for Deer­field, which placed a big wa­ger on the com­pa­ny ear­li­er this year in launch­ing Nu­va­lent to the tune of a $50 mil­lion Se­ries A. The blue chip firm owns more than 65% of shares pre-IPO. Nu­va­lent got start­ed based on solv­ing a prob­lem that can some­times oc­cur in tar­get­ed can­cer ther­a­pies, where the tar­get is al­ways chang­ing. Even though new­er gen­er­a­tions of drugs can ap­pear to hit the tar­get, mu­ta­tions will usu­al­ly pop up that thwart the ther­a­pies from ac­com­plish­ing their mis­sions. Har­vard pro­fes­sor Matt Shair, founder and head sci­en­tif­ic ad­vi­sor of Nu­va­lent, be­lieves chem­istry can evolve fast enough to keep pace with the dis­eases, he told End­points News in Jan­u­ary. While in stealth, he pushed the biotech to uti­lize struc­ture-based drug de­sign to de­vel­op two com­pounds that tar­get the tu­mor dri­vers ROS1 and ALK for the clin­ic. That ap­proach, Shair said, is com­ple­ment­ed with Nu­va­lent’s ef­forts to seek out physi­cian in­put for what kinds of prop­er­ties they want in a drug. Both pro­grams have yet to reach their first in-hu­man stud­ies, but IPO funds are ex­pect­ed to help launch Phase I por­tions of planned Phase I/II stud­ies for each can­di­date and push them through to com­ple­tion.

coverage

• Storm brews around Aduhelm as FDA re­quests probe; Dis­sect­ing pipeline dis­as­ters; Bob Nelsen is go­ing Re­al­ly Big; and more
• Nu­va­lent joins the IPO par­ty less than 6 months af­ter launch, while Icosavax kicks its 'soc­cer bal­l' VLPs to Nas­daq
• $DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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Icosavax’s tech­nol­o­gy comes out of Neil King’s lab at the Uni­ver­si­ty of Wash­ing­ton, where his team built on years-old re­search of how some vi­ral pro­teins could spon­ta­neous­ly as­sem­ble them­selves. Their work re­sult­ed in what’s es­sen­tial­ly a virus-like par­ti­cle shaped like a soc­cer ball — the “white” parts mak­ing up the struc­ture and the “black” spots rep­re­sent­ing the dis­played anti­gens, King told End­points in April. It’s the same tech King is us­ing to de­vel­op a “su­per-sea­son­al” flu vac­cine with the NIH, though Icosavax is not in­volved in that re­search. The biotech’s bi­va­lent vac­cine pro­gram, which will soak up most of the IPO cash, is go­ing af­ter res­pi­ra­to­ry syn­cy­tial virus and hu­man metap­neu­movirus. Icosavax’s plan is to start with the RSV “soc­cer ball” and then lay­er the hM­PV vac­cine on top of it as the new funds will help com­plete a Phase IIb study for the pro­gram. It’s not yet clear when the da­ta from this can­di­date will be ready, how­ev­er, as it’s not ex­pect­ed to be­gin a Phase I study un­til the sec­ond half of 2022. Oth­er IPO funds will be di­rect­ed to­ward the biotech’s Covid-19 vac­cine, with Icosavax look­ing to wrap up a Phase I/II tri­al thanks to the in­com­ing wind­fall.

coverage

• As health­care heats up on HKEX, Qim­ing sets up $500M fund ded­i­cat­ed to pub­lic com­pa­nies
• Storm brews around Aduhelm as FDA re­quests probe; Dis­sect­ing pipeline dis­as­ters; Bob Nelsen is go­ing Re­al­ly Big; and more
• Nu­va­lent joins the IPO par­ty less than 6 months af­ter launch, while Icosavax kicks its 'soc­cer bal­l' VLPs to Nas­daq

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Mar­tin Mack­ay got Rally­bio start­ed back in 2018 af­ter three decades work­ing in Big Phar­ma and big biotechs like Alex­ion. He re­cruit­ed two oth­er long­time Alex­ion vets fol­low­ing the com­pa­ny’s 2017 purge to launch his new biotech, with an eye on rare dis­eases. Mack­ay’s crew first dis­closed their tar­gets in May 2020, de­clar­ing a lead pro­gram for FNAIT, or fe­tal and neona­tal al­loim­mune throm­bo­cy­tope­nia. It’s a rare con­di­tion in which a fe­tus has anti­gens on platelet cells that a moth­er lacks, lead­ing to the moth­er’s body mount­ing an im­mune re­sponse that can po­ten­tial­ly cause fe­tal brain bleed­ing. Rally­bio is go­ing af­ter a pre­ven­ta­tive mea­sure with their RLYB211 can­di­date, hop­ing to give moth­ers a poly­clon­al an­ti-HPA-1a an­ti­body to tamp down on that im­mune re­sponse ear­ly in preg­nan­cies. The key will be iden­ti­fy­ing at-risk pa­tients, co-founder Stephen Uden told End­points at the time, as Rally­bio hopes to add the screen­ing to part of the rou­tine rare dis­ease tests women re­ceive dur­ing preg­nan­cy. Funds from the IPO raise are ex­pect­ed to be steered to­ward this pro­gram, with the S-1 not­ing it will be enough to com­plete the Phase I/II study as well as Phase I and Phase Ib tri­als for the sub­cu­ta­neous ver­sion RLYB212 that’s ex­pect­ed to en­ter the clin­ic in the first quar­ter of next year.

coverage

• UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street
• Jim Wil­son start­up Pas­sage Bio plugs in CFO, CMO; Till­man Gern­gross nabs a COO fa­mil­iar with Covid-19 fight at Pfiz­er as Ada­gio files for IPO
• Storm brews around Aduhelm as FDA re­quests probe; Dis­sect­ing pipeline dis­as­ters; Bob Nelsen is go­ing Re­al­ly Big; and more

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Sophia’s IPO marks the end of a long jour­ney in the pri­vate sec­tor for CEO Ju­r­gi Cam­b­long, who spent most of the biotech’s first nine years go­ing from one small raise to an­oth­er. But with the in­dus­try push to­ward big da­ta and ge­nomics, Cam­b­long is po­si­tion­ing Sophia to be a stand­out AI part­ner for drug de­vel­op­ers. The ul­ti­mate goal is to “be in the po­si­tion of Google,” he told End­points at the time of Sophia’s Oc­to­ber 2020 raise. And while his pitch strikes a fa­mil­iar tone of be­ing able to ag­gre­gate and sort through moun­tains of new da­ta to pro­vide clin­i­cal in­sights, Sophia is aim­ing to dif­fer­en­ti­ate it­self based on its sheer size. Through­out the last decade, Sophia has list­ed at least 1,000 hos­pi­tals as al­ready us­ing their plat­form to track pa­tients, in­clud­ing hun­dreds in the US. The in­fra­struc­ture that’s in place can fur­ther pro­vide re­al-world da­ta rather than sim­ply fo­cus on ge­nomics, though Cam­b­long not­ed their bio­phar­ma busi­ness is still very new af­ter launch­ing in 2019.

coverage

• No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more
• UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street
• Storm brews around Aduhelm as FDA re­quests probe; Dis­sect­ing pipeline dis­as­ters; Bob Nelsen is go­ing Re­al­ly Big; and more

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Cari­bou got its start in Jen­nifer Doud­na’s lab at Cal-Berke­ley, where CEO Rachel Hau­r­witz was Doud­na’s first grad­u­ate stu­dent to work on CRISPR. In 2011, they launched the com­pa­ny with James Berg­er, who’s now at the Johns Hop­kins School of Med­i­cine, and Mar­tin Jinek. What the com­pa­ny says sets it apart is its hy­brid DNA/RNA edit­ing plat­form, which Hau­r­witz calls chRD­NA (pro­nounced “chardon­nay,” like the wine). The biotech be­lieves the hy­brid guides can pre­vent off-tar­get edit­ing com­mon to cur­rent CRISPR ap­pli­ca­tions. Some of the IPO pro­ceeds will go to IND-en­abling ac­tiv­i­ties for Cari­bou’s oth­er two can­di­dates, CB-011 and CB-012. The for­mer tar­gets BC­MA for the treat­ment of re­lapsed/re­frac­to­ry mul­ti­ple myelo­ma and us­es “im­mune cloak­ing” to avoid the im­mune sys­tem. That can­di­date is ex­pect­ed to hit the clin­ic next year. CB-012 goes af­ter CD371, which Cari­bou says is an at­trac­tive tar­get for acute myeloid leukemia. The com­pa­ny is al­so look­ing to go be­yond on­col­o­gy, and they’re ex­plor­ing the ar­eas of im­mune cell ther­a­py, iP­SC, and in vi­vo-gene edit­ing. In Feb­ru­ary, Ab­b­Vie shelled out $40 mil­lion up­front with an­oth­er $300 mil­lion in biobucks for two of the biotech’s al­lo­gene­ic CAR-Ts.

coverage

• UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street
• Al­bireo re­veals $385K price tag for new­ly ap­proved pru­ri­tis drug; Jen­nifer Doud­na's Cari­bou up­sizes IPO
• WHO is­sues new guide­lines for gene edit­ing; Doud­na-backed Cari­bou launch­es its first al­lo­gene­ic CAR-T tri­al

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WCG Clin­i­cal Ser­vices launched back in 2012 as an al­ly to bio­phar­ma com­pa­nies and con­tract re­search or­ga­ni­za­tions, seek­ing to ad­dress what it calls “crit­i­cal pain points” in clin­i­cal tri­al per­for­mance. The Prince­ton, NJ-based com­pa­ny filed an S-1 on Thurs­day, pen­cil­ing in a $100 mil­lion raise. It claims to have sup­port­ed around 90% of glob­al clin­i­cal tri­als that took place over the last two years, pro­vid­ing ser­vices like study plan­ning, pa­tient en­gage­ment, and eth­i­cal re­view. The team par­tic­i­pat­ed in more than 723 Covid-19 tri­als, ac­cord­ing to CEO Don­ald Deieso. The com­pa­ny aims to tack­le is­sues like slow en­roll­ment, “bur­den­some ad­min­is­tra­tive process­es,” and the un­der-rep­re­sen­ta­tion of mi­nor­i­ty pa­tients.

coverage

• Busy IPO week winds down as two more biotechs — and one look­ing to im­prove clin­i­cal tri­als — file for pub­lic de­buts

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CEO Sean Mc­Clain start­ed Ab­sci as a 22-year-old col­lege grad­u­ate in a small base­ment lab — or as he called it, a “dun­geon lab” — in down­town Port­land, OR. Ten years lat­er, he’s tak­ing the com­pa­ny pub­lic. What start­ed as Mc­Clain’s search for a more ef­fi­cient way to man­u­fac­ture pro­teins in E. coli has led to the biotech’s pro­tein print­ing plat­form, which the team hopes can short­en the R&D process. They’ve moved out of the base­ment lab, and Mc­Clain said back in April that he plans to in­crease the staff to 225 by the end of this year. Ab­sci went com­mer­cial in 2018 with its E. coli ex­pres­sion plat­form, SoluPro, for pro­duc­ing sol­u­ble, com­plex pro­teins in high yields. The fol­low­ing year, it in­tro­duced its pro­tein print­ing plat­form, which builds on SoluPro with tech­nol­o­gy de­signed to pump out high-di­ver­si­ty strain li­braries and high-through­put screen­ing as­says. Ab­sci land­ed a $125 mil­lion crossover round back in March, and plans on us­ing the IPO pro­ceeds to ex­pand its plat­form, ac­cord­ing to an S-1 fil­ing. The biotech has part­nered with more than a dozen com­pa­nies, rang­ing from Mer­ck and Astel­las to a host of small­er play­ers.

coverage

• No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more
• UP­DAT­ED: Three biotechs price hefty IPOs just be­fore the week­end, while a fourth and a SPAC seek spots on Wall Street
• Great Danes: Two Nordic biotechs name their chief ex­ec­u­tives; Ax­el Hoos bids adieu to Glax­o­SmithK­line, be­comes CEO of small on­col­o­gy play­er

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For close to two decades, the com­pa­ny that would even­tu­al­ly be­come Can­del Ther­a­peu­tics had worked un­der the radar on on­colyt­ic virus­es. But now that it’s emerged from stealth with a new name, wooed Glax­o­SmithK­line vet Paul Pe­ter Tak to be CEO and set its first Phase III to sail, it is mak­ing good use of the lime­light. On­colyt­ic virus­es come with a check­ered his­to­ry. Am­gen’s Im­ly­g­ic re­mains the on­ly ap­proved prod­uct in the space, stand­ing out among a slew of fail­ures. Still, Can­del — and they’re not alone — reck­ons it rep­re­sents “one of the most promis­ing can­cer treat­ment modal­i­ties to­day.” The core idea is el­e­gant: If you can di­rect a non-repli­cat­ing virus to tu­mors, you can kill some can­cer cells and cause enough dam­age to star­tle the im­mune sys­tem in­to ac­tion, both at the lo­cal site and to metas­tases. Can­del’s pitch is to find the op­ti­mal virus to achieve this while adding a twist: use the virus as a vec­tor to de­liv­er trans­genes for an en­zyme, which would then con­vert a com­pan­ion small mol­e­cule pro­drug in­to can­cer killing mode. Hav­ing bagged a mod­est $66.1 mil­lion from ven­ture rounds — and burned through $48.6 mil­lion by late March — Can­del plans to chan­nel the IPO pro­ceeds di­rect­ly in­to those tri­als and fu­ture ones, as well as build­ing a new man­u­fac­tur­ing fa­cil­i­ty.

coverage

• Jim Wil­son start­up Pas­sage Bio plugs in CFO, CMO; Till­man Gern­gross nabs a COO fa­mil­iar with Covid-19 fight at Pfiz­er as Ada­gio files for IPO
• No hol­i­day for biotech IPOs as Rally­bio and Sophia Ge­net­ics sub­mit their Nas­daq pitch­es
• Eras­ing can­cer, re­viv­ing on­colyt­ic virus, treat­ing a rare neu­ro­mus­cu­lar con­di­tion: Here's what you need to know about the 5 new biotechs fil­ing for IPOs

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Just over a year af­ter com­plet­ing a mod­est $55 mil­lion Se­ries C round, French biotech Dy­nacure is look­ing for its own stock tick­er. Dy­nacure was found­ed in 2016 as part of a part­ner­ship be­tween Io­n­is and a French re­search cen­ter called the In­sti­tute of Ge­net­ics and Mol­e­c­u­lar and Cel­lu­lar Bi­ol­o­gy. While Io­n­is was on the verge of an ap­proval for its block­buster Spin­raza in spinal mus­cu­lar at­ro­phy, Dy­nacure was look­ing to use an­ti­sense to treat cen­tronu­clear my­opa­thy — a group of dis­or­ders sim­i­lar­ly marked by mus­cle wast­ing and weak­ness. The com­pa­ny’s lead can­di­date, DYN101, is cur­rent­ly in a Phase I/II tri­al in Eu­rope, and re­searchers hope to ex­pand the tri­al in the Unit­ed States in the sec­ond half of this year, the F-1 states. Dy­nacure’s plan­ning an in­ter­im phar­ma­co­ki­net­ic and safe­ty read­out in the sec­ond half of 2022, with fi­nal da­ta slat­ed for 2023.

coverage

• IPOs con­tin­ue to bus­tle as three more biotechs pre­pare to make the Nas­daq leap
• Eras­ing can­cer, re­viv­ing on­colyt­ic virus, treat­ing a rare neu­ro­mus­cu­lar con­di­tion: Here's what you need to know about the 5 new biotechs fil­ing for IPOs
• Dy­nacure se­cures $55M as their Io­n­is-de­vel­oped drug moves in­to clin­ic

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Al­most a year af­ter ex­pand­ing an al­ready mas­sive Se­ries B round, Eras­ca has filed S-1 pa­pers in the hopes of ad­vanc­ing its name­sake mis­sion: eras­ing can­cer. CEO Jonathan Lim launched the com­pa­ny back in 2018, af­ter auc­tion­ing off his com­pa­ny Igny­ta to Roche for a tidy $1.7 bil­lion. For the first cou­ple of years, Lim re­leased few de­tails on what the com­pa­ny was work­ing on. Then at the be­gin­ning of this year, he un­veiled two pro­grams tar­get­ing pro­teins in a key can­cer sig­nal­ing path­way called RAS/MAPK. Eras­ca’s two clin­i­cal pro­grams in­clude ERAS-601, li­censed from NiKand Ther­a­peu­tics, and ERAS-007, ac­quired from ASN Prod­uct De­vel­op­ment. They both tar­get the RAS/MAPK path­way, which is be­hind as many as half of all sol­id tu­mors, ac­cord­ing to Eras­ca. When the path­way be­comes over­ac­tive, can­cer cells can grow in an un­con­trolled fash­ion. ERAS-601 and ERAS-007 in­hib­it SHP2 and ERK, re­spec­tive­ly: two pro­teins that act as “on/off switch­es” to the RAS/MAPK path­way. By tar­get­ing the pro­teins and clamp­ing down on the sig­nal­ing path­way, sci­en­tists be­lieve they can turn the RAS/MAPK switch “off,” shut­ting down can­cer cells’ abil­i­ty to grow and pro­lif­er­ate. The plan is to have four can­di­dates in the clin­ic with­in the next six quar­ters, and file an ad­di­tion­al IND every 12 to 18 months over the next five years.

coverage

• Bio­gen pressed against the wall as more stake­hold­ers side against Aduhelm; Prime time for CRISPR 3.0?; and more
• Nas­daq rings in Jonathan Lim's next can­cer play, Pfiz­er-backed start­up and Har­vard spin­out with col­lec­tive $534M raise un­der their belts
• No hol­i­day for biotech IPOs as Rally­bio and Sophia Ge­net­ics sub­mit their Nas­daq pitch­es

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Back in No­vem­ber, Ima­go pulled in an $80 mil­lion crossover round that CEO Hugh Rien­hoff said would lead to a pub­lic de­but some­time this year, and that came to fruition in late June. They’re look­ing to cre­ate small mol­e­cules that tar­get ly­sine-spe­cif­ic demethy­lase 1 (LSD1), an en­zyme that plays a role in the pro­duc­tion of blood cells in the bone mar­row. The com­pa­ny read out pos­i­tive Phase II re­sults in mid-June for its lead can­di­date, bomedem­stat, in bone mar­row can­cers. In the study, 10 out of 12 pa­tients with es­sen­tial throm­bo­cythemia, a rare dis­or­der in which the body pro­duces too many platelets, dosed for more than six weeks showed a sig­nif­i­cant re­duc­tion of platelet counts. The drop hap­pened while pa­tients main­tained sta­ble he­mo­glo­bin lev­els, the com­pa­ny said. And in a sep­a­rate study in pa­tients with ad­vanced myelofi­bro­sis — a type of bone can­cer that dis­rupts the body’s nor­mal pro­duc­tion of blood cells — 94% of pa­tients showed a re­duc­tion of 50% or more in symp­toms. Up­on un­veil­ing the com­pa­ny’s Se­ries C in No­vem­ber, CBO Ed Barac­chi­ni told End­points News that the best-case sce­nario would be to launch both Phase III stud­ies in mid-2022. Ac­cord­ing to the S-1, Ima­go plans on de­vel­op­ing bomedem­stat and oth­er LSD1-tar­get­ing can­di­dates for oth­er in­di­ca­tions such as poly­cythemia ve­ra, he­mo­glo­binopathies and sol­id tu­mors.

coverage

• Nas­daq rings in Jonathan Lim's next can­cer play, Pfiz­er-backed start­up and Har­vard spin­out with col­lec­tive $534M raise un­der their belts
• Eras­ing can­cer, re­viv­ing on­colyt­ic virus, treat­ing a rare neu­ro­mus­cu­lar con­di­tion: Here's what you need to know about the 5 new biotechs fil­ing for IPOs
• Au­to­lus claims a CAR-T win at EHA; Ima­go touts two PhII tri­al wins for rare dis­ease drug

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Vi­vid­ion made it pret­ty ob­vi­ous that an IPO was in the works. The Se­ries C that Jeff Hat­field had as­sem­bled back in Feb­ru­ary bore all the sig­na­tures of a crossover: Al­ready backed by ARCH and Ver­sant, Vi­vid­ion gath­ered the $135 mil­lion raise from a dream team of A-list in­vestors. What might be sur­pris­ing about the S-1 fil­ing is the de­tails the biotech has un­veiled, for the first time, about the pipeline — es­pe­cial­ly the pro­grams it’s de­vel­op­ing on be­half of part­ners at Bris­tol My­ers Squibb and Roche. Cel­gene helped put Vi­vid­ion on the map back in 2018 when it paid $95 mil­lion in cash to kick­start a re­search pact. Up un­til now, Hat­field had been tight-lipped about what Cel­gene — now part of Bris­tol My­ers Squibb — went with as the ini­tial pro­gram, say­ing on­ly that it’s “one of a hand­ful of Holy Grail tar­gets in on­col­o­gy and im­munol­o­gy.” With the help of its chemo­pro­teom­ic plat­form, Vi­vid­ion wrote, it has un­cov­ered a pock­et on STAT3 that they can make oral­ly avail­able com­pounds against, there­by achiev­ing “near com­plete in­hi­bi­tion” of STAT3. Vi­vid­ion and BMS are look­ing at both on­col­o­gy and im­munol­o­gy ap­pli­ca­tions. As for Roche, Vi­vid­ion not­ed they are de­vel­op­ing a slate of WRN in­hibitors.

coverage

• Ex-Vi­vid­ion chief Diego Mi­ralles finds 'dream team' at stealthy Flag­ship port­fo­lio com­pa­ny; Astel­las looks in­ward to se­lect CBO and CSO
• For­mer Glax­o­SmithK­line CEO An­drew Wit­ty takes the helm at Unit­ed­Health; Af­ter more than a decade, Daniel Chung is back on a fa­mil­iar project
• Alk­er­mes pro­motes from with­in to find new CFO and COO in re­bound ef­fort; Mod­er­na vet Robert Dol­s­ki joins Check­mate as CFO

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This SPAC is run by Someit Sid­hu, a co-founder of Pathios Ther­a­peu­tics, as well as CEO of Akaza Bio­science and Izana Bio­science. Join­ing Sid­hu on the team are Tauhid Ali, a for­mer Take­da vet who launched three biotechs out of the phar­ma’s in­cu­ba­tor, and Arnout Ploos van Am­s­tel, for­mer head of No­var­tis’ im­munol­o­gy, he­pa­tol­ogy and der­ma­tol­ogy fran­chis­es. Com­pared with some of the oth­er SPACs out there, Sid­hu is a rel­a­tive­ly un­known play­er. He doesn’t have the name recog­ni­tion of some­one like Richard Bran­son, Eli Cas­din or Vin­od Khosla, nor the os­ten­si­ble cult fol­low­ing of “SPAC King” and ear­ly Face­book ex­ec­u­tive Chamath Pal­i­hapi­tiya. What he does have, at least ac­cord­ing to the SEC fil­ing, is ex­pe­ri­ence at the con­sult­ing firm McK­in­sey where he cut his teeth ad­vis­ing un­named glob­al phar­ma com­pa­nies. He al­so holds a de­gree from Ox­ford Med­ical School with an em­pha­sis on car­di­ol­o­gy and gen­er­al surgery. Sid­hu’s two biotechs — whose web­sites, for what­ev­er rea­son, are near­ly iden­ti­cal — are part­nered with Take­da and the UK gov­ern­ment’s in­no­va­tion agency. Akaza is aim­ing to bring an old Take­da com­pound through clin­i­cal tri­als for the treat­ment of acute-on-chron­ic liv­er fail­ure, while Izana is push­ing an­oth­er for­mer Take­da pro­gram in Covid-19 and rheuma­toid arthri­tis.

coverage

• Tri­al soft­ware group rais­es $45M to push de­cen­tral­ized stud­ies; $120M SPAC makes its way to Nas­daq
• Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more
• An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans

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Can a fresh­wa­ter sponge be used to treat skin con­di­tions like ac­ne, pso­ri­a­sis and rosacea? That’s what Der­ma­ta wants to find out. The com­pa­ny’s plat­form is based on the use of Spongilla la­cus­tris, a nat­u­ral­ly grow­ing fresh­wa­ter sponge that’s tra­di­tion­al­ly used as a folk med­i­cine for var­i­ous in­flam­ma­to­ry con­di­tions. How­ev­er, Der­ma­ta be­lieves Spongilla’s nat­ur­al de­fense mech­a­nisms could prove use­ful in treat­ing skin con­di­tions, like ac­ne vul­garis. Those mech­a­nisms in­clude mi­cro­scop­ic siliceous spicules that are unique­ly sized to pen­e­trate the skin, cre­at­ing mi­crochan­nels for the sponge’s nat­u­ral­ly oc­cur­ring chem­i­cals or oth­er macro­mol­e­cules to pen­e­trate in­to the der­mis. The spicules are al­so be­lieved to open black­heads and pro­mote col­la­gen pro­duc­tion, which could ac­cel­er­ate re­ju­ve­na­tion of the skin. While Spongilla grows in rivers and lakes in the north­ern hemi­sphere, there are a lim­it­ed num­ber of places in which it grows in a large enough quan­ti­ty to be used as a raw ma­te­r­i­al, Der­ma­ta said in its S-1. How­ev­er, the com­pa­ny has picked out a spot in cen­tral Rus­sia to har­vest the sponge.

coverage

• The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

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Not much is known about Ocean Bio­med­ical, but it’s kick­ing off its pub­lic quest with an ini­tial $100 mil­lion raise es­ti­mate, per their S-1. The com­pa­ny says its busi­ness mod­el is cen­tered around a “li­cens­ing and sub­sidiary struc­ture,” al­low­ing them to bet­ter lever­age re­la­tion­ships with­in acad­e­mia and VC firms. Its CEO is Eliz­a­beth Ng, a for­mer di­rec­tor of strat­e­gy de­vel­op­ment at Mer­ck who has al­so held se­nior po­si­tions at Gilead and Bio­Marin. Ocean’s pipeline cur­rent­ly con­sists of five pro­grams rang­ing from on­col­o­gy and in­fec­tious dis­ease to fi­bro­sis and in­flam­ma­tion. Brown Uni­ver­si­ty li­censed their NSCLC, glioblas­toma mul­ti­forme and pul­monary fi­bro­sis can­di­dates, while Rhode Is­land Hos­pi­tal li­censed their malar­ia vac­cine pro­gram. The in­flam­ma­tion can­di­date is seek­ing to treat Covid-19 by re­duc­ing cy­tokines and comes from Stan­ford. Keep­ing things close to the vest, Ocean did not say how it would spend its IPO funds, on­ly not­ing that one of its pro­grams will be mov­ing in­to a clin­i­cal tri­al with the raise.

coverage

• The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

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This Mi­ra­mar, FL-based biotech is aim­ing to re­search the con­nec­tion be­tween chron­ic in­flam­ma­tion and ag­ing, coin­ing the buzzy and on­ly-in-Flori­da term “in­flam­mag­ing” to de­scribe its tar­gets. HCW has plans for four clin­i­cal tri­als to be up and run­ning by the end of the year, with two al­ready on­go­ing and two ex­pect­ed to launch. All four stud­ies are cen­tered around the lead can­di­date HCW9201, which the biotech hopes will be able to spur the gen­er­a­tion of mem­o­ry-like NK cells. The pro­gram was co-de­vel­oped with re­searchers at Wash­ing­ton Uni­ver­si­ty in St. Louis, and the ini­tial tar­get in­di­ca­tion is re­lapsed/re­frac­to­ry acute myeloid leukemia. IPO funds will go to­ward launch­ing the new tri­als in pan­cre­at­ic can­cer and oth­er sol­id tu­mor in­di­ca­tions, in ad­di­tion to pre­clin­i­cal stud­ies and a Phase I alope­cia area­ta tri­al for a sec­ond pro­gram.

coverage

• The next SPAC is here, com­ing from a phar­ma e-com­merce CEO, as a Flori­da biotech prices at the low end
• What ad­u­canum­ab means for Alzheimer's, un­pack­ing a safe­ty bar­ri­er in CAR-T, the push to up­grade a key ALS tri­al tool, and more
• Five more biotechs file their SEC pa­per­work as the IPO Class of 2021 swells to 60

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Con­text is fo­cus­ing on can­cers found in women, in­clud­ing ovar­i­an, breast and en­dome­tri­al. They ex­pect to read out Phase II re­sults for its on­ly clin­i­cal can­di­date lat­er this year, for ovar­i­an can­cer pa­tients who ex­press high lev­els of prog­es­terone re­cep­tor. The com­pa­ny is al­so run­ning an­oth­er Phase II tri­al look­ing at the pro­gram in com­bi­na­tion with Arim­idex in PR+ en­dome­tri­al pa­tients, with da­ta ex­pect­ed in the first half of next year.

coverage

• In­ter­cept re­tools C-suite with a pair of new­com­ers; Charles Ryan moves past Alzheimer's flops with an­oth­er CEO chal­lenge
• With two de­buts and a SPAC, bio­phar­ma notch­es an­oth­er busy week as IPO raise soars past $7B
• Palleon's first CSO ex­plains how they (and she) got here; En­ter­prise taps Roche and No­var­tis vet David Mor­ris as CMO

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The SPAC from Cy­to­com CEO Michael Han­d­ley filed for a $100 mil­lion raise for its shell com­pa­ny on May 26. Its syn­di­cate in­cludes Han­d­ley and Nicholas Hem­mer­ly, head of in­vest­ment bank­ing at Bridge­way Cap­i­tal Part­ners. The blank-check com­pa­ny will re­port­ed­ly fo­cus on mid-to-late stage clin­i­cal as­sets.

coverage

• With two de­buts and a SPAC, bio­phar­ma notch­es an­oth­er busy week as IPO raise soars past $7B

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On­coSec Med­ical CEO Daniel O’Con­nor has filed the S-1 pa­per­work for his blank-check com­pa­ny. O’Con­nor is a for­mer crim­i­nal pros­e­cu­tor in Som­er­set Coun­ty, NJ, and was CEO of Ad­vax­is be­fore leav­ing the com­pa­ny abrupt­ly — and with­out of­fer­ing a rea­son — in 2017. He’s now lead­ing On­coSec’s ef­forts to de­vel­op an IL-12 can­cer ther­a­py that’s ac­ti­vat­ed by elec­tro­po­ra­tion, or a se­ries of mo­men­tary en­er­gy puls­es.

coverage

• Cure­Vac gains COO and hands Flo­ri­an von der Mülbe new as­sign­ment in the midst of Covid-19 vac­cine trou­bles; As Ken Fra­zier re­tires, Mer­ck hires chief strat­e­gy of­fi­cer
• Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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TScan’s planned leap to Nas­daq is com­ing just three months af­ter the biotech pulled in a nine-fig­ure crossover round in Jan­u­ary, which at­tract­ed high-pro­file firms Black­Rock and RA Cap­i­tal Man­age­ment. The Har­vard Uni­ver­si­ty spin­out is build­ing a repos­i­to­ry of clin­i­cal­ly-ac­tive TCRs us­ing its high-through­put whole genome dis­cov­ery plat­form. The com­pa­ny had com­pared it to a vend­ing ma­chine or a li­brary of sorts, be­fore fi­nal­ly set­tling on the term “bank,” CEO David South­well said at the time of the crossover. TScan’s ap­proach comes from the lab of Har­vard pro­fes­sor Stephen Elledge, who set out years ago to screen anti­gen-TCR match­es in a faster, more sys­tem­at­ic way. He spent 7 years putting to­geth­er the tech for a plat­form that could run mul­ti­ple TCRs against anti­gen epi­topes and pin­point the ex­act pairs that ap­pear to in­ter­act. Now, what be­gan as 96 plates in Elledge’s lab has trans­formed in­to a com­pa­ny that has raised $180 mil­lion to date and at­tract­ed the likes of No­var­tis. The biotech plans to sub­mit INDs for its lead two liq­uid tu­mor can­di­dates in the fourth quar­ter, and at least three of its four sol­id tu­mor can­di­dates in the sec­ond half of 2022.

coverage

• Nas­daq rings in Jonathan Lim's next can­cer play, Pfiz­er-backed start­up and Har­vard spin­out with col­lec­tive $534M raise un­der their belts
• Stephen Elledge's Har­vard lab again proves fruit­ful with the launch of high-through­put an­ti­body start­up
• Stephen Elledge's Har­vard lab takes $17M to birth Im­muneID, a high-through­put an­ti­body start­up

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For­mer­ly known as 3-V Bio­sciences, Sagimet fo­cus­es on de­vel­op­ing se­lec­tive FASN in­hibitors for liv­er dis­eases and can­cers in­clud­ing NASH, for which they re­leased pos­i­tive Phase II da­ta for the pro­gram TVB-2640 in June 2020. Sagimet said the can­di­date’s high dose had a 61% re­sponse rate across 30 pa­tients and led to a mean liv­er fat re­duc­tion of 28.2%. And this Feb­ru­ary, Sagimet pulled in an $80 mil­lion Se­ries F crossover to help launch a Phase IIb study for that pro­gram. The FASN en­zyme is in­volved in lipid syn­the­sis. In­hibit­ing it, in the­o­ry, could re­duce fat pro­duc­tion and al­le­vi­ate these tar­get dis­eases. Sagimet’s S-1 laid out a fair­ly vague plan for its IPO raise, not­ing on­ly that some funds will help the stud­ies and man­u­fac­tur­ing for TVB-2640, as well as launch­ing a first in-hu­man tri­al for an­oth­er pro­gram.

coverage

• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings
• Mys­tery in­vestors back a new NASH ap­proach; GSK an­tibi­otics sale trig­gers lay­off fears

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Gy­ro­scope post­poned its IPO just hours be­fore it was due to go pub­lic, in light of “mar­ket con­di­tions,” the com­pa­ny an­nounced May 7. The com­pa­ny lat­er with­drew its plans in ear­ly June. Pri­or to that, it had been look­ing to cap­i­tal­ize on its sig­nif­i­cant mo­men­tum from the first quar­ter. Back in Feb­ru­ary, the UK-based biotech post­ed an ear­ly win for its AMD gene ther­a­py, not­ing pa­tients who re­spond­ed to their GT005 can­di­date in a Phase I/II tri­al saw a 146% in­crease in an im­por­tant bio­mark­er and a de­crease in fur­ther down­stream bio­mark­ers. Then in March, Gy­ro­scope took that win to the bank in clos­ing a $148 mil­lion Se­ries C. Less than a month lat­er, Gy­ro­scope is push­ing for­ward to Nas­daq. The $100 mil­lion writ­ten out in their F-1 is like­ly a mod­est place­hold­er, giv­en the na­ture of their Se­ries C just a few weeks ago. The com­pa­ny plans to use a sig­nif­i­cant por­tion of its pro­ceeds to ad­vance GT005 in three stud­ies, as well as fund re­search in an­oth­er prod­uct known as GT011. GT005 is cur­rent­ly in two Phase II stud­ies for pa­tients with ge­o­graph­ic at­ro­phy, an ir­re­versible de­gen­er­a­tion of reti­nal cells caused by dry-AMD. The can­di­date is in­ject­ed un­der the reti­na to in­crease pro­duc­tion of the Com­ple­ment Fac­tor I pro­tein, which Gy­ro­scope be­lieves could damp­en an over­ac­tive com­ple­ment sys­tem that’s been tied to wors­en­ing at­ro­phy in AMD pa­tients.

coverage

• News brief­ing: Gy­ro­scope and Ta­laris set IPO terms; FDA grants ex­pand­ed nod to Chiesi's sick­le cell drug
• Eli Lil­ly plots NDA as sec­ond JAK study backs baric­i­tinib for alope­cia area­ta; Al­ny­lam heads to FDA af­ter full vutrisir­an da­ta pan out
• Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings

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Un­til ear­li­er this year, Arti­va didn’t have much of a pro­file in bio­phar­ma land. For­mer Bel­licum CEO Tom Far­rell had as­sem­bled an NK cell ther­a­py com­pa­ny, lean­ing heav­i­ly on a “huge­ly im­pres­sive” man­u­fac­tur­ing fa­cil­i­ty be­long­ing to Green Cross Lab­Cell in Ko­rea, gath­ered $78 mil­lion in Se­ries A mon­ey and did the news rounds last June, then stayed large­ly qui­et. That changed when Mer­ck signed a col­lab­o­ra­tion worth near­ly $2 bil­lion in mile­stones to pick up the off-the-shelf NK cell tech. Arti­va quick­ly fol­lowed up with a $120 mil­lion Se­ries B, de­signed to kick­start Phase I/II for its lead pro­gram in non-Hodgkin’s lym­phoma. The part­ner­ship deal, Arti­va re­vealed in its S-1, gave GC Lab­Cell a 28% stake in the biotech, al­most dou­ble the hold­ings of 5AM Ven­tures, ven­Bio, RA Cap­i­tal and more than quadru­ple what Ven­rock has.

coverage

• John Robin­son re­cruits a small band of Ar­ray vets to kick­start dis­cov­ery at Co­gent; Syn­tim­mune co-founder takes charge at Arch On­col­o­gy
• Dean Li kicks off Mer­ck­'s post-Roger Perl­mut­ter era by team­ing with Arti­va and its off-the-shelf CAR-NK tech
• Alk­er­mes pro­motes from with­in to find new CFO and COO in re­bound ef­fort; Mod­er­na vet Robert Dol­s­ki joins Check­mate as CFO

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Found­ed and led by CRO vet Michael Dud­ley, Boston-based TransCode Ther­a­peu­tics is fo­cused on de­liv­er­ing RNA drugs to where they are need­ed to kill can­cer, and they are am­bi­tious. All of their pro­grams are still in the pre­clin­i­cal stage, with the lead can­di­date de­signed to treat metasta­t­ic can­cer — mean­ing tu­mors in the breast, pan­creas, ovary, colon or even the brain. Ac­cord­ing to the com­pa­ny’s S-1, TransCode’s strat­e­gy seeks to over­come de­liv­ery chal­lenges by re­pur­pos­ing a par­ti­cle, which are used ex­ten­sive­ly in hu­mans for imag­ing pur­pos­es, to de­liv­er syn­thet­ic RNA mol­e­cules to can­cer cells. TransCode is al­so de­vel­op­ing a PD-L1 that they’re hop­ing to use for pan­cre­at­ic can­cer, melanoma, NSCLC and breast can­cer. For their next step, the com­pa­ny in­tends to ad­vance the lead pro­gram to the clin­ic for those suf­fer­ing from late-stage can­cer. In March 2020, TransCode re­ceived FDA guid­ance for their first pro­posed study as part of its pre-IND sub­mis­sion. TransCode set its terms on May 4 and slashed its val­u­a­tion by about 41%, per Re­nais­sance Cap­i­tal.

coverage

• With TransCode go­ing pub­lic, in­dus­try sur­pass­es $10B IPO mark; Galect­in's in­hibitor shows PhIb suc­cess in can­cer treat­ment
• Four IPOs and a SPAC pitch a new slate of mi­cro­bio­me, can­cer and in­flam­ma­to­ry drugs to Wall Street

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Acu­men Phar­ma­ceu­ti­cals is a se­cre­tive play­er, but giv­en its re­search in­to Alzheimer’s dis­ease, they could be un­der the spot­light more fre­quent­ly fol­low­ing the FDA’s con­tro­ver­sial de­ci­sion to ap­prove Bio­gen’s Aduhelm. Acu­men’s re­search deals with amy­loid-be­ta oligomers, and it notes in its S-1 — per­haps nod­ding to the Bio­gen de­ci­sion — that “based on decades of re­search and sup­port­ing ev­i­dence, AbOs have gained in­creas­ing sci­en­tif­ic ac­cep­tance as a pri­ma­ry tox­in in­volved in the ini­ti­a­tion and prop­a­ga­tion of AD pathol­o­gy.” The com­pa­ny not­ed the dis­tinc­tion be­tween amy­loid-be­ta monomers and amy­loid plaques as well. This re­search has cul­mi­nat­ed in a mon­o­clon­al an­ti­body called ACU193, co-de­vel­oped with Mer­ck, which launched a Phase I tri­al in the sec­ond quar­ter. Acu­men is look­ing for po­ten­tial ef­fects in ear­ly-stage pa­tients, seek­ing to en­roll those with mild de­men­tia or cog­ni­tive im­pair­ment in its study. Da­ta are ex­pect­ed by the fourth quar­ter of next year. Go­ing fur­ther than Ocean, Acu­men gave ex­act­ly ze­ro de­tails over how it would use the IPO raise. The “Use of Pro­ceeds” sec­tion of their S-1, while typ­i­cal­ly scant on specifics, un­usu­al­ly con­tains on­ly boil­er­plate lan­guage in Acu­men’s fil­ing.

coverage

• Watch out, Pfiz­er and Mod­er­na; An­ti-ag­ing break­through in mice?; Neu­ro for the new GSK; and more
• Vet­er­an amy­loid cham­pi­on helps Alzheimer's start­up grab $160M in IPO as in­vestors charge back in to a once fad­ed field
• Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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This SPAC comes from the out­spo­ken “Piped Piper of SPACs,” Chamath Pal­i­hapi­tiya. A for­mer Face­book ex­ec­u­tive and co-own­er of the NBA’s Gold­en State War­riors, Pal­i­hapi­tiya launched four SPACs all tar­get­ing dif­fer­ent sec­tors of biotech. Pal­i­hapi­tiya has been a promi­nent and in­flu­en­tial fig­ure in this realm, hav­ing pre­vi­ous­ly launched a slate of six SPACs span­ning mul­ti­ple in­dus­tries. Four of his firms have found part­ners thus far, in­clud­ing one that took fel­low bil­lion­aire Richard Bran­son’s space tourism com­pa­ny Vir­gin Galac­tic pub­lic. He’s on­ly grown his in­flu­ence since the start of the Covid-19 pan­dem­ic, cul­ti­vat­ing a large au­di­ence of stuck-at-home mil­len­ni­al and Gen Z re­tail in­vestors through his Twit­ter ac­count and a pop­u­lar week­ly pod­cast. One of Pal­i­hapi­tiya’s oth­er SPAC-backed com­pa­nies, Clover Health In­vest­ments, has al­so seen re­cent in­ter­est from Red­dit in­vestors, but was the sub­ject of an in­ves­ti­ga­tion from Hin­den­burg Re­search in Feb­ru­ary, al­leg­ing Clover and Pal­i­hapi­tiya mis­led re­tail in­vestors in the run-up to the pub­lic tran­si­tion. His first SPAC will look for biotechs work­ing in neu­rol­o­gy.

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This SPAC comes from the out­spo­ken “Piped Piper of SPACs,” Chamath Pal­i­hapi­tiya. A for­mer Face­book ex­ec­u­tive and co-own­er of the NBA’s Gold­en State War­riors, Pal­i­hapi­tiya launched four SPACs all tar­get­ing dif­fer­ent sec­tors of biotech. Pal­i­hapi­tiya has been a promi­nent and in­flu­en­tial fig­ure in this realm, hav­ing pre­vi­ous­ly launched a slate of six SPACs span­ning mul­ti­ple in­dus­tries. Four of his firms have found part­ners thus far, in­clud­ing one that took fel­low bil­lion­aire Richard Bran­son’s space tourism com­pa­ny Vir­gin Galac­tic pub­lic. He’s on­ly grown his in­flu­ence since the start of the Covid-19 pan­dem­ic, cul­ti­vat­ing a large au­di­ence of stuck-at-home mil­len­ni­al and Gen Z re­tail in­vestors through his Twit­ter ac­count and a pop­u­lar week­ly pod­cast. One of Pal­i­hapi­tiya’s oth­er SPAC-backed com­pa­nies, Clover Health In­vest­ments, has al­so seen re­cent in­ter­est from Red­dit in­vestors, but was the sub­ject of an in­ves­ti­ga­tion from Hin­den­burg Re­search in Feb­ru­ary, al­leg­ing Clover and Pal­i­hapi­tiya mis­led re­tail in­vestors in the run-up to the pub­lic tran­si­tion. His sec­ond SPAC will look for biotechs work­ing in on­col­o­gy.

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This SPAC comes from the out­spo­ken “Piped Piper of SPACs,” Chamath Pal­i­hapi­tiya. A for­mer Face­book ex­ec­u­tive and co-own­er of the NBA’s Gold­en State War­riors, Pal­i­hapi­tiya launched four SPACs all tar­get­ing dif­fer­ent sec­tors of biotech. Pal­i­hapi­tiya has been a promi­nent and in­flu­en­tial fig­ure in this realm, hav­ing pre­vi­ous­ly launched a slate of six SPACs span­ning mul­ti­ple in­dus­tries. Four of his firms have found part­ners thus far, in­clud­ing one that took fel­low bil­lion­aire Richard Bran­son’s space tourism com­pa­ny Vir­gin Galac­tic pub­lic. He’s on­ly grown his in­flu­ence since the start of the Covid-19 pan­dem­ic, cul­ti­vat­ing a large au­di­ence of stuck-at-home mil­len­ni­al and Gen Z re­tail in­vestors through his Twit­ter ac­count and a pop­u­lar week­ly pod­cast. One of Pal­i­hapi­tiya’s oth­er SPAC-backed com­pa­nies, Clover Health In­vest­ments, has al­so seen re­cent in­ter­est from Red­dit in­vestors, but was the sub­ject of an in­ves­ti­ga­tion from Hin­den­burg Re­search in Feb­ru­ary, al­leg­ing Clover and Pal­i­hapi­tiya mis­led re­tail in­vestors in the run-up to the pub­lic tran­si­tion. His third SPAC will look for biotechs work­ing in “the or­gan space sub­sec­tor,” which he de­fined as “in­trin­sic dis­eases of the heart, kid­ney, en­docrine sys­tem (in­clud­ing di­a­betes and lipids) and blood com­part­ment (non-on­co­log­ic dis­eases).”

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This SPAC comes from the out­spo­ken “Piped Piper of SPACs,” Chamath Pal­i­hapi­tiya. A for­mer Face­book ex­ec­u­tive and co-own­er of the NBA’s Gold­en State War­riors, Pal­i­hapi­tiya launched four SPACs all tar­get­ing dif­fer­ent sec­tors of biotech. Pal­i­hapi­tiya has been a promi­nent and in­flu­en­tial fig­ure in this realm, hav­ing pre­vi­ous­ly launched a slate of six SPACs span­ning mul­ti­ple in­dus­tries. Four of his firms have found part­ners thus far, in­clud­ing one that took fel­low bil­lion­aire Richard Bran­son’s space tourism com­pa­ny Vir­gin Galac­tic pub­lic. He’s on­ly grown his in­flu­ence since the start of the Covid-19 pan­dem­ic, cul­ti­vat­ing a large au­di­ence of stuck-at-home mil­len­ni­al and Gen Z re­tail in­vestors through his Twit­ter ac­count and a pop­u­lar week­ly pod­cast. One of Pal­i­hapi­tiya’s oth­er SPAC-backed com­pa­nies, Clover Health In­vest­ments, has al­so seen re­cent in­ter­est from Red­dit in­vestors, but was the sub­ject of an in­ves­ti­ga­tion from Hin­den­burg Re­search in Feb­ru­ary, al­leg­ing Clover and Pal­i­hapi­tiya mis­led re­tail in­vestors in the run-up to the pub­lic tran­si­tion. His fourth SPAC will look for biotechs work­ing in im­munol­o­gy.

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Aerovate will jump straight to the pub­lic mar­ket just a few weeks af­ter ap­point­ing a new CEO. Tim­o­thy Noyes took over from Ben Dake at the end of May, the founder who shift­ed to the role of pres­i­dent. Noyes was a for­mer CEO at Pro­teon Ther­a­peu­tics and served as pres­i­dent of Gen­zyme’s re­nal di­vi­sion. Aerovate’s fo­cus has been to de­vel­op and run tri­als of a dry-pow­der ver­sion of the land­mark can­cer drug ima­tinib, which is meant to be used with an in­haler. It’s tar­get­ing pul­monary ar­te­r­i­al hy­per­ten­sion, hop­ing the pow­der can more di­rect­ly treat the con­di­tion by go­ing di­rect­ly to the lung. Dake pre­vi­ous­ly told End­points the prod­uct would prove more at­trac­tive than a typ­i­cal liq­uid neb­u­liz­er where pa­tients have to mix their own so­lu­tions. The Boston biotech first emerged from stealth out of RA Cap­i­tal’s in­cu­ba­tor last Au­gust, net­ting $72.6 mil­lion to de­vel­op AV-101. That pro­gram sits at the cen­ter of Aerovate’s IPO plans, as the com­pa­ny ex­pects to fund a Phase IIb/III study through com­ple­tion of the Phase IIb part and da­ta read­out of the Phase III por­tion. More IPO cash will be steered to­ward the man­u­fac­tur­ing costs of the pro­gram and to its ex­pect­ed com­mer­cial launch.

coverage

• Watch out, Pfiz­er and Mod­er­na; An­ti-ag­ing break­through in mice?; Neu­ro for the new GSK; and more
• A dry-pow­der lung dis­ease drug and next-gen an­tibi­otics: Two biotechs and an $880M slate of SPACs land on Wall Street with big ideas
• Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

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Six months af­ter launch­ing his first biotech SPAC, Fore­site’s Jim Tanan­baum start­ed a sec­ond. It’s a quick re­turn to Wall Street for Fore­site af­ter Tanan­baum sim­i­lar­ly man­aged to find a quick home for his first SPAC, merg­ing with the ge­net­ics-dri­ven eye dis­ease com­pa­ny Gem­i­ni Ther­a­peu­tics in a $216 mil­lion deal in Oc­to­ber 2020. This new SPAC raised $175 mil­lion and priced on Feb. 17, and an­nounced its in­tent to merge with Pardes in late June. The biotech got an­oth­er $75 mil­lion in pri­vate fund­ing from Gilead, RA Cap­i­tal Man­age­ment and Fra­zier Life Sci­ences. Gilead and the VC firms are back­ing a dark-horse ef­fort by a sea­soned vi­rol­o­gy ex­ec­u­tive to win the race for the first, or at least best, ef­fec­tive pill against Covid-19. Ac­cord­ing to doc­u­ments Pardes filed with the SEC, the com­pa­ny was found­ed at the be­gin­ning of 2020 by Uri Lopatin, a for­mer Gilead ex­ec­u­tive who co-found­ed and served as CMO of As­sem­bly Bio­sciences — one of the lead­ing play­ers in the hunt for a he­pati­tis B cure un­til a tri­al fail­ure last No­vem­ber — for near­ly a decade.

coverage

• Watch out, Pfiz­er and Mod­er­na; An­ti-ag­ing break­through in mice?; Neu­ro for the new GSK; and more
• Gilead, Fore­site take an un­known pan­dem­ic an­tivi­ral pub­lic in $250M SPAC deal

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El­e­va­tion On­col­o­gy has spent its time try­ing to re­vamp Mer­ri­mack’s high-pro­file serib­an­tum­ab pro­gram in­to some­thing that can treat sol­id tu­mors with the rare NRG1 ge­nom­ic fu­sion. Af­ter flop­ping in NSCLC, serib­an­tum­ab was ac­quired by El­e­va­tion back in 2019 for up to $58 mil­lion. The drug can­di­date is a mon­o­clon­al an­ti­body that binds to HER3 and was one in a long string of clin­i­cal busts for Mer­ri­mack, ul­ti­mate­ly re­sult­ing in the biotech sell­ing sev­er­al as­sets and lay­ing off all its staff and ex­ec­u­tives. El­e­va­tion launched in Ju­ly 2020 and quick­ly added a $65 mil­lion Se­ries B round to com­plete en­roll­ment in a Phase II study. Their S-1 was scant on de­tails over how far El­e­va­tion wants to take the pro­gram with its raise.

coverage

• Are 'plat­form plays' here to stay?; The Aduhelm saga con­tin­ues to un­fold; A new GSK?; and more
• Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing
• Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B

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Al­pha Tekno­va has been around since 2000, but now it’s go­ing pub­lic on the backs of its reagents. The Hol­lis­ter, CA-based com­pa­ny says it has about 3,000 cus­tomers span­ning the en­tire life sci­ences mar­ket, in­clud­ing biotechs, larg­er phar­ma com­pa­nies and CROs. Al­pha Tekno­va of­fers three prod­ucts: pre-poured me­dia plates for cell growth and cloning, liq­uid cell cul­ture me­dia and sup­ple­ments for cel­lu­lar ex­pan­sion, and mol­e­c­u­lar bi­ol­o­gy reagents for sam­ple ma­nip­u­la­tion, re­sus­pen­sion and pu­rifi­ca­tion. Funds from the IPO will large­ly go to­ward up­ping man­u­fac­tur­ing and im­prov­ing ef­fi­cien­cy, though Al­pha Tekno­va said it couldn’t quan­ti­fy ex­act­ly how much.

coverage

• Are 'plat­form plays' here to stay?; The Aduhelm saga con­tin­ues to un­fold; A new GSK?; and more
• Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing
• Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B

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The psy­che­delics space con­tin­ues to see heavy in­vestor in­ter­est, and RA Cap­i­tal backed GH Re­search in April with a nine-fig­ure round. GH is tak­ing its pro­grams pub­lic, with a lead in­halant cen­tered around the sub­stance col­lo­qui­al­ly known as “toad ven­om.” Though the drug’s sci­en­tif­ic name is a mouth­ful — 5-Methoxy-N, N-di­methyl­trypt­a­mine is the of­fi­cial name — it picked up the toad ven­om nick­name due to its pres­ence in a cer­tain toad species na­tive to the south­west­ern US and north­west­ern Mex­i­co. The psy­che­del­ic saw a rapid rise in recre­ation­al use in the mid-2010s, per a VICE News re­port, as in­di­vid­u­als at­tempt­ed to achieve the ‘ego death’ phe­nom­e­non. GH is start­ing with treat­ment-re­sis­tant de­pres­sion and has two oth­er undis­closed in­di­ca­tions on tap. The DMT in­halant, dubbed GH001, is cur­rent­ly be­ing stud­ied in the Phase II por­tion of a Phase I/II clin­i­cal tri­al. The Dublin-based biotech is al­so work­ing on an in­jectable for­mu­la­tion of the drug. GH’s IPO raise is ex­pect­ed to help de­vel­op both of these can­di­dates, with a Phase IIb study planned for GH001 and a Phase IIa tri­al to like­ly be set up for the oth­er can­di­date.

coverage

• Ar­row­head touts Phase Ib RNAi da­ta for ccR­CC; PureTech lines up PD-1 from BeiGene for up­com­ing com­bo study
• Are 'plat­form plays' here to stay?; The Aduhelm saga con­tin­ues to un­fold; A new GSK?; and more
• Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing

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Graphite came out of a part­ner­ship from Ver­sant and Stan­ford gene ther­a­py ex­perts, first get­ting things start­ed back in Sep­tem­ber 2020 with a $45 mil­lion round. Now they’re ready to make the pub­lic leap less than a year lat­er, ex­pect­ing to launch their first clin­i­cal tri­al by the end of 2021 in sick­le cell dis­ease. The plat­form comes from Matthew Por­teus, an aca­d­e­m­ic founder of CRISPR Ther­a­peu­tics, who is work­ing along­side gene ther­a­py ex­pert Maria Grazia Ron­car­o­lo. Draw­ing from re­search work led by Dan­ny De­v­er while a post­doc at Por­teus’ lab, Graphite’s big promise is to in­crease in­te­gra­tion ef­fi­cien­cy from less than 1% to greater than 50% “across di­verse ge­net­ic le­sions in a wide range of cell types.” The trio each serve as the co-aca­d­e­m­ic founders at Graphite. The biotech has since built up its pipeline in­to three pro­grams, with can­di­dates for X-linked se­vere com­bined im­mune de­fi­cien­cy and Gauch­er dis­ease on top of the sick­le cell lead. All three are ex­pect­ed to be fun­neled cash with the IPO, and the two fol­low-up pro­grams are still in IND-en­abling stud­ies.

coverage

• Sean Park­er-backed cell ther­a­py start­up Ar­se­nal­Bio plucks Mer­ck VP as new CSO
• Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing
• Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B

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The Stat­en Is­land, NY-based Acurx is work­ing on a slate of an­tibi­otics that look to block the DNA poly­merase II­IC en­zyme. They’re ex­pect­ed to be­gin a Phase IIb tri­al for their lead can­di­date, ibeza­pol­stat, this year in pa­tients with C. dif­fi­cile in­fec­tions.

coverage

• Watch out, Pfiz­er and Mod­er­na; An­ti-ag­ing break­through in mice?; Neu­ro for the new GSK; and more
• A dry-pow­der lung dis­ease drug and next-gen an­tibi­otics: Two biotechs and an $880M slate of SPACs land on Wall Street with big ideas
• Graphite Bio leads this week's IPO squad, look­ing to turn the tide on sick­le cell dis­ease with gene edit­ing

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Since last Sep­tem­ber, Monte Rosa has pulled in two fundrais­ing rounds of $96 mil­lion and $95 mil­lion apiece. That mo­men­tum is lead­ing them to­ward the next step of be­com­ing a pub­lic com­pa­ny. Their plat­form re­volves around de­vel­op­ing “mol­e­c­u­lar glues” that can re­pro­gram the ubiq­ui­tin lig­as­es cen­tral to pro­tein degra­da­tion, a field that’s been pro­duc­ing tons of buzz among in­vestors over the last cou­ple years. The re­sult­ing can­di­dates are dif­fer­ent from oth­er small mol­e­cule de­graders, such as PRO­TAC, that work more like in­hibitors. Monte Rosa doesn’t have any clin­i­cal pro­grams just yet, but they’ve been plan­ning IND stud­ies for their lead can­di­date by the end of this June. The ex­per­i­men­tal drug will tar­get GSPT1, a reg­u­la­to­ry pro­tein im­pli­cat­ed in the syn­thet­ic lethal­i­ty of sol­id tu­mor cells. With­in its S-1, Monte Rosa stayed silent over ex­act­ly how far it ex­pects to bring this pro­gram, on­ly di­vulging that some of the cash will be di­rect­ed to­ward it. The rest of the mon­ey will help fund fur­ther de­vel­op­ment of the plat­form and oth­er pre­clin­i­cal pro­grams.

coverage

• Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B
• Monte Rosa pulls in $95M to test its 'mol­e­c­u­lar glues,' and the first tar­get is GSPT1
• Ex-Vi­vid­ion chief Diego Mi­ralles finds 'dream team' at stealthy Flag­ship port­fo­lio com­pa­ny; Astel­las looks in­ward to se­lect CBO and CSO

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23andMe, one of the buzzi­est names in health­care and de­liv­er­ing per­son­al­ized med­i­cine di­rect­ly based on a cus­tomer’s ge­net­ics went pub­lic, an­nounced it was go­ing pub­lic via Richard Bran­son’s SPAC in Feb­ru­ary. Large­ly known for its sali­va-col­lec­tion prod­ucts that re­searchers can an­a­lyze to map out an in­di­vid­ual’s an­ces­try and de­ter­mine ge­net­ic risks to cer­tain dis­eases, 23andMe has made a push in re­cent years to en­ter the drug de­vel­op­ment space. In 2018, they signed a $300 mil­lion deal with GSK to al­low the big phar­ma ex­clu­sive ac­cess to its ge­net­ic data­base, though ques­tions re­mained at the time over ex­act­ly how it would be uti­lized. That part­ner­ship be­gan to bear fruit in 2020, as the pair launched their first clin­i­cal tri­al. In Ju­ly of that year, pa­tients be­gan en­rolling in a study for a CD96-block­ing an­ti­body aimed at di­rect­ing the im­mune sys­tem to at­tack can­cer cells. Ef­forts from the agree­ment have since led to the iden­ti­fi­ca­tion of rough­ly 30 drug tar­gets, the com­pa­nies said at the time. They’ve al­so out-li­censed the first drug pro­gram it de­vel­oped in-house, sign­ing a deal with Span­ish der­ma­tol­ogy com­pa­ny Almi­rall for a bis­pe­cif­ic an­ti­body that blocks three cy­tokines in the IL-36 fam­i­ly. 23andMe’s merg­er closed on June 17.

coverage

• Hal Bar­ron's chase for ge­net­ic clues leads Glax­o­SmithK­line back to neu­ro — and makes new biotech part­ner $700M rich­er overnight
• The Covid-19 trans­genic cow an­ti­body start­up goes pub­lic in $325M SPAC merg­er
• The dig­i­tal health field con­tin­ues to boom as Soft­Bank-backed start­up hits uni­corn sta­tus in SPAC re­verse merg­er

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Backed by bil­lion­aire Pe­ter Thiel, ATAI has out­lined its plans to take its port­fo­lio of ex­per­i­men­tal psy­che­del­ic med­i­cines to Nas­daq. If ATAI’s pre­vi­ous two fundrais­es are any in­di­ca­tion, their fi­nal IPO raise could be sig­nif­i­cant. Last No­vem­ber, ATAI raised $125 mil­lion in a Se­ries C that was co-led by Thiel’s firm, scor­ing the com­pa­ny a $1 bil­lion post-mon­ey val­u­a­tion. Then in March, ATAI “dou­bled down” on their strat­e­gy, as CEO Flo­ri­an Brand told End­points at the time, scor­ing a $157 mil­lion Se­ries D. That marked a four-month span in which the com­pa­ny saw near­ly $300 mil­lion of cap­i­tal flow in­to its cof­fers, book­end­ing the ad­di­tion of Recog­ni­fy Life Sci­ences and its schiz­o­phre­nia pro­grams in­to the ATAI fam­i­ly of com­pa­nies. ATAI func­tions as a par­ent com­pa­ny for sev­er­al biotechs work­ing on men­tal health ther­a­peu­tics, bring­ing port­fo­lio com­pa­nies un­der one um­brel­la. In April, ATAI brought in its 14th such port­fo­lio firm with Psy­ber, which looks to im­prove men­tal health dis­or­ders and in­duce be­hav­ioral changes through “brain com­put­er in­ter­face” tech­nol­o­gy. ATAI has iden­ti­fied pro­grams from six of its com­pa­nies that will be the pri­ma­ry fo­cus of its IPO funds. The S-1 lists the com­pa­nies as Per­cep­tion, Recog­ni­fy, De­meRx, GA­BA, Neu­ronasal and Viridia, with ATAI look­ing to launch ei­ther Phase I or Phase II stud­ies for their drug can­di­dates.

coverage

• An­oth­er four IPOs com­plete busy week as biotech raise con­tin­ues to match 2020's record pace
• The Har­vard sci­en­tist act­ing as ATAI's trea­sure trove launch­es a new psy­che­delics firm fo­cused on drug 'ana­logues'
• Pe­ter Thiel-backed ATAI is prepar­ing to go to Nas­daq, as in­ter­est in psy­che­delics reach­es fever pitch

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Cen­tu­ry Ther­a­peu­tics is one of sev­er­al ris­ing al­lo­gene­ic cell ther­a­py play­ers look­ing to cap­i­tal­ize on hefty fundrais­es in their leap to the pub­lic do­main. The IPO will come just a few months af­ter CEO La­lo Flo­res steered Cen­tu­ry to a $160 mil­lion raise, an im­pres­sive sum that fol­lowed a launch megaround of $250 mil­lion back in Ju­ly 2019. Cen­tu­ry is tak­ing a slight­ly dif­fer­ent ap­proach than oth­er biotechs in the are­na, bank­ing on in­duced pluripo­tent stem cells rather than donor cells. Flo­res not­ed that Cen­tu­ry is “plat­form ag­nos­tic,” de­vel­op­ing both CAR-T and CAR-NKs cre­at­ed with its iP­SCs. The lead pro­gram is a CD19 CAR-NK that they hope to steer in­to a hu­man tri­al by 2022, and Cen­tu­ry will push some of its IPO fund­ing to­ward this goal. If all goes well, Flo­res en­vi­sions a drug to be stored as a frozen prod­uct in hos­pi­tals. The pre­clin­i­cal pipeline goes af­ter a slate of hema­to­log­i­cal ma­lig­nan­cies as well as sol­id tu­mors like glioblas­toma, where they would de­ploy a bis­pe­cif­ic CAR. A tri­umvi­rate of those pre­clin­i­cal pro­grams tar­get­ing CD133 and EGFR, CD19 and CD79b, as well as an­oth­er mul­ti­spe­cif­ic can­di­date, will al­so get some IPO cash, with Cen­tu­ry look­ing to com­plete the full slate of IND-en­abling stud­ies by the end of 2024.

coverage

• An­oth­er four IPOs com­plete busy week as biotech raise con­tin­ues to match 2020's record pace
• An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus
• Five more biotechs file their SEC pa­per­work as the IPO Class of 2021 swells to 60

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This will be Am­brx’s sec­ond at­tempt to go pub­lic af­ter an ini­tial ef­fort in 2014 came up short. The ear­li­er at­tempt left the San Diego com­pa­ny scram­bling as the board OK’d a rad­i­cal­ly dif­fer­ent strat­e­gy to move for­ward, ap­prov­ing a plan to sell it­self to a syn­di­cate of Chi­nese in­vestors and phar­ma com­pa­nies. Am­brx laid low for the next five or so years, re­turn­ing to the scene last No­vem­ber with a $200 mil­lion crossover raise. That crossover marked the cul­mi­na­tion of Am­brx’s piv­ot to Chi­na, af­ter the biotech had spent much of its ear­ly years rack­ing up part­ner­ships with Amer­i­can phar­mas like Mer­ck, Bris­tol My­ers Squibb and Eli Lil­ly. Since 2015, Am­brx has signed dis­cov­ery deals with BeiGene, Suzhou-based Mab­Space and Shang­hai-based NovoCodex, among oth­ers. Am­brx plans to fo­cus its IPO cash large­ly on their first in-house drug, a HER2-tar­get­ing an­ti­body-drug con­ju­gate called ARX788, which they’ve moved in­to the clin­ic. Re­searchers are tar­get­ing breast and gas­tric can­cer, as well as oth­er sol­id tu­mors. There will al­so be ef­forts to fund the com­pa­ny’s prostate can­cer and EPB pro­grams.

coverage

• An­oth­er four IPOs com­plete busy week as biotech raise con­tin­ues to match 2020's record pace
• An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus
• Five more biotechs file their SEC pa­per­work as the IPO Class of 2021 swells to 60

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CEO Markus Ren­schler had pre­vi­ous­ly dis­cussed his com­pa­ny’s plans to go pub­lic some­time in 2021, but that it hadn’t yet fi­nal­ized the ex­act tim­ing. Now, the Nas­daq jump will come rough­ly four months af­ter Cyteir pulled in an $80 mil­lion Se­ries C round, which the biotech used to hire more em­ploy­ees and fur­ther its lead can­di­date to a Phase II study. The pro­gram, an in­hibitor of RAD51-me­di­at­ed DNA re­pair dubbed CYT-0851, is be­ing eval­u­at­ed as a monother­a­py and tar­gets RAD51 — a crit­i­cal en­zyme in dou­ble-strand­ed DNA re­pair, as Cyteir re­search­es the con­cept of syn­thet­ic lethal­i­ty. It’s a phe­nom­e­non that could po­ten­tial­ly in­hib­it the DNA dam­age re­pair that can­cer cells need to sur­vive and grow, Ren­schler told End­points in Feb­ru­ary. IPO funds are ex­pect­ed to car­ry this pro­gram through the com­ple­tion of its Phase II tri­al, as well as fund an­oth­er pro­gram go­ing af­ter the re­la­tion­ship be­tween cy­ti­dine deam­i­nas­es and ho­mol­o­gous re­com­bi­na­tion.

coverage

• An­oth­er four IPOs com­plete busy week as biotech raise con­tin­ues to match 2020's record pace
• Five more biotechs file their SEC pa­per­work as the IPO Class of 2021 swells to 60
• With crossover round in its pock­et, syn­thet­ic lethal­i­ty-fo­cused Cyteir Ther­a­peu­tics eyes a jump on­to Nas­daq

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Mol­e­c­u­lar Part­ners is os­ten­si­bly seek­ing to cap­i­tal­ize on the March news that one of their an­tivi­ral pro­grams will par­tic­i­pate in an NIH-run Covid-19 tri­al. The Swiss biotech teamed up with No­var­tis for the can­di­date, which is what they’re call­ing a “trispe­cif­ic” DARPin an­tivi­ral known as enso­vibep. Re­searchers will eval­u­ate the an­tivi­ral as part of the NIH’s AC­TIV-3, the hos­pi­tal­ized mild-to-mod­er­ate pa­tient arm of their AC­TIV pro­to­col against Covid-19. If the med­i­cine hits all its mile­stones, No­var­tis will be on the hook for up to $231 mil­lion. But Mol­e­c­u­lar Part­ners is al­so fo­cus­ing on eye dis­eases, on­col­o­gy and AML. The com­pa­ny has a Phase III pro­gram for wet AMD where they’ve part­nered with Al­ler­gan/Ab­b­Vie and a lead can­cer pro­gram for FAP-pos­i­tive can­cers in col­lab­o­ra­tion with Am­gen. The biotech has three pro­grams it ex­pects to fund with its IPO: a Phase I tri­al for its sec­ond on­col­o­gy pro­gram seek­ing to bind FAP and CD40, to com­plete a Phase I study for the sec­ond No­var­tis-part­nered Covid-19 pro­gram known as MP0423, and to ad­vance their liq­uid tu­mor port­fo­lio in AML through Phase I as well.

coverage

• An­oth­er four IPOs com­plete busy week as biotech raise con­tin­ues to match 2020's record pace
• Rick Klaus­ner's crew of T cell spe­cial­ists wraps $425M IPO, hit­ting Nas­daq along­side Verve, Mol­e­c­u­lar Part­ners
• Lat­est news: Com­mit­tee votes to restart J&J vac­ci­na­tions, check­point gi­ants prep de­fense, un­der­dog vac­cine en­ters the spot­light, and more

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Rick Klaus­ner has as­sem­bled an all-star team to shift the cell ther­a­py par­a­digm at Lyell, and teamed up with Glax­o­SmithK­line R&D chief Hal Bar­ron as part of a $600 mil­lion launch round in 2019. The cast in­cludes co-founder Stan Rid­dell, EVP of sci­ence Nick Res­ti­fo, CSO Mar­go Roberts and sci­en­tif­ic founders Crys­tal Mack­all of Stan­ford and David Bak­er of the Uni­ver­si­ty of Wash­ing­ton. Every­thing is still pre­clin­i­cal, and the $150 mil­lion list­ed in the S-1 is like­ly a place­hold­er for a mas­sive IPO round to come. But they ex­pect to rec­ti­fy that in their fourth year, with four INDs an­tic­i­pat­ed in 2022. Pre­sum­ably hu­man proof-of-con­cept da­ta to track their quest would fol­low soon af­ter. Klaus­ner stepped away from found­ing CEO role to make way for Eliz­a­beth Homans, and could be in for a sub­stan­tial wind­fall if it all plays out as planned. The sci­en­tist/en­tre­pre­neur has more than 16 mil­lion shares cur­rent­ly — 7.2% of the to­tal. Klaus­ner’s in­vest­ment group Milky Way, which has tak­en a stake in a va­ri­ety of biotechs, has 8% of the com­pa­ny. And around 12.5 mil­lion of his per­son­al shares are ex­er­cis­able with­in 90 days of March 31.

coverage

• On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?
• Rick Klaus­ner's crew of T cell spe­cial­ists wraps $425M IPO, hit­ting Nas­daq along­side Verve, Mol­e­c­u­lar Part­ners
• T cell ther­a­py play­er Lyell pre­pares to open $65M man­u­fac­tur­ing fa­cil­i­ty in the Seat­tle area

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Sekar Kathire­san’s ef­fort to pi­o­neer the next gen­er­a­tion of gene edit­ing is go­ing pub­lic on the backs of mon­key da­ta they be­lieve could change the way a ge­net­ic dis­or­der re­sult­ing in ex­treme cho­les­terol lev­els is treat­ed. That dis­ease, fa­mil­ial hy­per­c­ho­les­terolemia, is one that oth­er com­pa­nies are go­ing af­ter, in­clud­ing Pre­ci­sion Bio­sciences. Tar­get­ing the PSCK9 gene in the liv­er, Verve re­searchers made a sin­gle change from A to G in the ge­net­ic se­quence with the goal of de­ac­ti­vat­ing the gene for good. So far, Verve says the da­ta have proved durable. Back at the JP Mor­gan con­fer­ence in Jan­u­ary, Kathire­san un­veiled six-month fol­low-up da­ta show­ing how their ap­proach low­ered LDL cho­les­terol and av­er­age blood PC­SK9 pro­tein lev­els and kept them low for six months. Giv­en that liv­er cells re­plen­ish af­ter about 200 days, Kathire­san said at the time the con­tin­ued low lev­els sug­gest that the tech­nol­o­gy is work­ing. Verve ex­pects to dose its first pa­tient some time in 2022 for the het­erozy­gous form of the dis­ease, and Kathire­san is hop­ing to ex­pand its pipeline to tar­get at least sev­en oth­er genes re­lat­ed to the LDL-C, triglyc­erides or lipopro­tein(a) path­ways.

coverage

• David Liu takes the wraps off $315M launch round for Prime Med­i­cine and new CRISPR tech that gave Bob Nelsen a 'holy crap' mo­ment
• Hit­ting land­mark mile­stone, In­tel­lia shows CRISPR can ed­it genes di­rect­ly in pa­tients
• Rick Klaus­ner's crew of T cell spe­cial­ists wraps $425M IPO, hit­ting Nas­daq along­side Verve, Mol­e­c­u­lar Part­ners

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The week af­ter Bio­gen’s con­tro­ver­sial ap­proval for its Alzheimer’s drug Aduhelm, Alza­mend Neu­ro priced a $12.5 mil­lion IPO to take its own slate of neu­rode­gen­er­a­tive drugs in­to the clin­ic. The lead can­di­date, AL001, is an ion­ic cocrys­tal of lithi­um cre­at­ed at the Uni­ver­si­ty of South Flori­da. While con­ven­tion­al lithi­um salts have long been used as a pro­phy­lac­tic for de­pres­sion — and are cur­rent­ly used as a mood sta­bi­liz­er for pa­tients with bipo­lar dis­or­der — they re­quire mul­ti­ple dos­es through­out the day to reach ther­a­peu­tic con­cen­tra­tions in the blood. Cur­rent lithi­um drugs like lithi­um chlo­ride and lithi­um car­bon­ate suf­fer tox­i­c­i­ties and poor phys­io­chem­i­cal prop­er­ties. But Alza­mend thinks it doesn’t have to be that way. Sci­en­tists at USF set out to make a new lithi­um cocrys­tal com­po­si­tion that would al­low for low­er dos­ing, with im­proved phys­io­chem­i­cal prop­er­ties. Alza­mend plans on sub­mit­ting an IND for AL001 by the end of June, and tagged $5.3 mil­lion in IPO funds for topline read­outs on Phase I tri­als in mild to mod­er­ate Alzheimer’s.

coverage

• An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus
• Gur­net Point-backed Au­re­gen taps Am­gen vet to lead; Ex-Roche RNA chief takes CEO post at Genevant

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Hot off of a $1 bil­lion deal with Mer­ck signed in De­cem­ber, Janux is tak­ing the fa­bled Nas­daq leap. De­cem­ber’s deal left Janux el­i­gi­ble for up to $500.5 mil­lion in up­front and mile­stone pay­ments ear­marked for each of two tar­gets se­lect­ed by Mer­ck. But ac­cord­ing to its S-1, Mer­ck paid just $8 mil­lion up­front in con­nec­tion to the first tar­get, and will pay an­oth­er $8 mil­lion up­on the se­lec­tion of the sec­ond. Janux will re­ceive mile­stone pay­ments of $142.5 mil­lion for each of the tar­gets that suc­cess­ful­ly reach reg­u­la­tion, and the re­main­ing po­ten­tial $350 mil­lion will de­pend on sales of the li­censed prod­uct. Janux com­plet­ed a $56 mil­lion Se­ries A in March, then in late April, the com­pa­ny an­nounced a $125 mil­lion crossover round led by RA Cap­i­tal, a Boston VC be­hind sev­er­al pre-IPO fi­nanc­ings. It’s a com­pa­ny that’s flour­ished since the Mer­ck deal, de­spite not en­ter­ing the clin­ic yet. The small San Diego biotech was found­ed in 2017 on a T cell en­gager plat­form called TRAC­Tr, which promis­es to pro­duce drugs that al­ter their phar­ma­co­ki­net­ics de­pend­ing on the con­text.

coverage

• Jim Wil­son start­up Pas­sage Bio plugs in CFO, CMO; Till­man Gern­gross nabs a COO fa­mil­iar with Covid-19 fight at Pfiz­er as Ada­gio files for IPO
• Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more
• The IPO 4-1-1: Four fil­ings, a pric­ing and a with­draw­al head­line this week's Nas­daq ac­tion as raise ap­proach­es $7.5B

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This merg­er, an­nounced June 9, in­volves the first of three SPACs launched by Vin­od Khosla, mak­ing up rough­ly $300 mil­lion out of a $1.2 bil­lion play. At the time he filed his SEC pa­per­work, Khosla wrote a brief but polem­i­cal let­ter on the im­por­tance of star­tups and rein­ven­tion, giv­ing on­ly vague hints at what he may be tar­get­ing with his shell com­pa­nies. Still, that let­ter gives ref­er­ence to CRISPR Cas9, ear­ly de­tec­tion of Alzheimer’s and de­men­tia, Genen­tech, and how the in­creas­ing use of AI could help turn the “prac­tice of med­i­cine” to the “sci­ence of med­i­cine” — no­table in­clu­sions for a tech firm that has in re­cent years in­creas­ing­ly wad­ed in­to biotech. The SPAC priced on March 4.

coverage

• The Covid-19 trans­genic cow an­ti­body start­up goes pub­lic in $325M SPAC merg­er
• Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more
• The Flag­ship train keeps chug­ging with its 'in­ter­sys­tem­s' play­er eye­ing the clin­ic next year with 3 new drugs

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The SPAC from Lo­cust Walk Part­ners will re­verse-merge with eF­FEC­TOR Ther­a­peu­tics, tak­ing the $175 mil­lion from the SPAC raise with a $60 mil­lion PIPE fi­nanc­n­ing. Fund­ing from the deal will help the biotech com­plete its Phase IIb tri­al for its lead can­di­date, an oral small-mol­e­cule in­hibitor of mi­to­gen-ac­ti­vat­ed pro­tein ki­nas­es 1 and 2, in com­bi­na­tion with Keytru­da. There are al­so plans to launch mul­ti­ple Phase IIa stud­ies for an­oth­er pro­gram, a small-mol­e­cule in­hibitor of eIF4A. The SPAC syn­di­cate in­cludes Chris Ehrlich, se­nior man­ag­ing di­rec­tor at Lo­cust Walk, and Daniel Gef­fken, founder and man­ag­ing di­rec­tor of Dan­forth Ad­vi­sors.

coverage

• Lat­est news: Am­gen's land­mark OK for KRAS drug, in­side Ver­tex 3.0, the big hunt for CAR-T in sol­id tu­mors, and more
• With two de­buts and a SPAC, bio­phar­ma notch­es an­oth­er busy week as IPO raise soars past $7B
• Alk­er­mes pro­motes from with­in to find new CFO and COO in re­bound ef­fort; Mod­er­na vet Robert Dol­s­ki joins Check­mate as CFO

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Francesco De Ru­ber­tis made no se­cret of IPO plans for Centes­sa, his 10-in-1 lega­cy play, back in Feb­ru­ary. Bare­ly two months lat­er, the S-1 is in and he’s pen­ciled in the all-too-com­mon $100 mil­lion place­hold­er, de­spite launch­ing the com­pa­ny with $250 mil­lion. The goal is sim­i­lar to the one he brought over from Medicxi: take their as­set-cen­tric mind­set and roll up a bunch of biotech up­starts, with un­re­lat­ed risk pro­files, in­to one phar­ma com­pa­ny that can car­ry on the de­vel­op­ment at scale. They’ll be do­ing it with­out Mon­cef Slaoui, who was fea­tured promi­nent­ly in the ini­tial press re­lease as chief sci­en­tif­ic of­fi­cer and ad­vi­sor. Eject­ed from a promi­nent Glax­o­SmithK­line-af­fil­i­at­ed board seat and all biotech po­si­tions fol­low­ing a “sub­stan­ti­at­ed” case of sex­u­al ha­rass­ment (for which he apol­o­gized), the re­tired Op­eraion Warp Speed chief was nowhere to be seen in the S-1. There are 11 sub­sidiaries that make up Centes­sa, two of which have sub­se­quent­ly merged. They in­clude In­ex­ia, a 3-year-old biotech whose as­sets were trans­ferred ear­li­er this year to Orex­ia. Of the 16 pro­grams now in the Centes­sa pipeline, the four clin­i­cal-stage as­sets will re­ceive the largest chunk of cash from the IPO raise.

coverage

• Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at Cata­ma­ran Bio, team­ing up again with ex-Dis­arm CEO
• With Kathy High on board, AskBio makes next lead­er­ship play and se­lects Bay­er's Gu­ru Ra­ma­murthy as fi­nance chief; Myles O'Neill and Melis­sa Barnes set to re­tire from Eli Lil­ly

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Omid Farokhzad is jump­ing in­to the SPAC game, and he’s go­ing in with one of the most ex­pe­ri­enced teams we’ve seen in biotech. The for­mer Har­vard pro­fes­sor had been co-founder for a string of biotechs be­fore de­cid­ing to de­vote him­self to a new role as CEO of Seer, where the big idea these past 2 years-plus has been to shift away from ge­nomics in fa­vor of a pro­teomics plat­form that is do­ing some pop­u­la­tion-wide ex­plo­rations. That’s en­abled him to build a moun­tain of da­ta that can be probed with ma­chine learn­ing tech in search of in­sights in­to dis­eases, help­ing de­vel­op liq­uid biop­sy prod­ucts for ear­ly-stage di­ag­noses. Mostafa Ron­aghi is tak­ing the CEO role at the Dy­nam­ics Spe­cial Pur­pose blank check out­fit to Farokhzad’s ex­ec­u­tive chair­man post. Ron­aghi, who had been a Stan­ford sci­en­tist, was un­til re­cent­ly the CTO at Il­lu­mi­na, co-found­ed Grail and sits on the Seer board.

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As the phar­ma in­dus­try con­tin­ues de­vel­op­ing and push­ing for­ward can­cer treat­ments, Day One ex­ecs ar­gue that the main­stream play­ers left pe­di­atric can­cer be­hind. Adult pa­tients make up a sig­nif­i­cant­ly big­ger por­tion of the mar­ket, the com­pa­ny said, and there have been lags in un­der­stand­ing pe­di­atric bi­ol­o­gy prop­er­ly. Day One’s mis­sion, then, is to try to fill that gap by de­vel­op­ing tar­get­ed ther­a­pies aimed specif­i­cal­ly at chil­dren. Their pro­posed treat­ments are en­tire­ly new ef­forts rather than re­for­mu­lat­ing adult treat­ments that come with heavy side ef­fects, like ra­di­a­tion ther­a­py and chemo. Their lead pro­gram is a for­mer Take­da pro­gram called DAY101, an oral pan-RAF in­hibitor that can cross the blood-brain bar­ri­er and block mu­ta­tions in gliomas. As such, Day One is aim­ing for an in­di­ca­tion to treat pe­di­atric low-grade gliomas, the most com­mon form of brain tu­mors in chil­dren. The cur­rent stan­dard of care is plat­inum-based chemo, with no clear fa­vorite be­yond that, Ben­der told End­points News in Feb­ru­ary.

coverage

• It’s a new $DAWN for Day One as start­up piv­ots to an IPO for more fund­ing to back its work in pe­di­atric can­cer
• The right to vote is fun­da­men­tal — a let­ter from biotech­nol­o­gy in­dus­try lead­ers

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Ve­ra’s IPO came up well short of its ini­tial S-1 es­ti­mate, net­ting on­ly $47.58 mil­lion af­ter orig­i­nal­ly list­ing $86 mil­lion. It al­so came in be­low its ex­pect­ed range, pric­ing ini­tial­ly at $11 per share. For­mer­ly known as Tru­code Gene Re­pair, Ve­ra re-launched it­self in Jan­u­ary with an $80 mil­lion Se­ries C with plans to fo­cus their ef­forts on at­aci­cept, a 20-year-old mol­e­cule now in de­vel­op­ment for kid­ney dis­ease. It marked a quick piv­ot for the com­pa­ny, which had on­ly orig­i­nal­ly de­buted back in Sep­tem­ber 2019. In an in­ter­view fol­low­ing the Se­ries C, CEO Mar­shall Fordyce wouldn’t pro­vide de­tails on why the biotech chose to move on so quick­ly from its cen­tral tech­nol­o­gy, but Ve­ra now has a much clear­er line of sight on com­mer­cial­iza­tion. At­aci­cept dates back to the now-de­funct Seat­tle biotech Zy­mo­Ge­net­ics, which in 2001 signed a de­vel­op­ment deal for au­toim­mune dis­eases with the then-in­de­pen­dent com­pa­ny Serono. In 2009, short­ly be­fore they were bought out by Bris­tol My­ers Squibb, Zy­mo­Ge­net­ics li­censed the mol­e­cule to Mer­ck KGaA, who kept it go­ing in a va­ri­ety of mid and late-stage tri­als. Most of those came up short, in­clud­ing stud­ies on mul­ti­ple scle­ro­sis, lu­pus and rheuma­toid arthri­tis. But ear­li­er this year, Mer­ck an­nounced new Phase IIa da­ta for pa­tients with IgA nephropa­thy. Last No­vem­ber, Ve­ra li­censed the drug for a 10% eq­ui­ty stake in the biotech and €605 mil­lion in mile­stones.

coverage

• Eli Lil­ly part­ner Ab­Cellera finds a CBO in the face of bam­lanivimab strug­gles; Fi­bro­Gen's next CSO walks in­to rox­adu­s­tat re­buff
• Gene ther­a­py play­er turned kid­ney spe­cial­ist Ve­ra drops a dud in lead­up to Nas­daq, pric­ing well be­low range
• Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

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This SPAC comes from the fam­i­ly fund of tech bil­lion­aire Michael Dell, a syn­thet­ic bi­ol­o­gy leg­end out of MIT and Har­vard and the for­mer di­rec­tor of the NCI. His in­vest­ment team in­cludes James Huang, the Tai­wanese born man­ag­ing part­ner of Klein­er Perkins Cau­field & By­ers Chi­na who launched Panacea a few years ago, as well as John Phe­lan, the co-found­ing part­ner at Dell’s MSD Part­ners and MSD Cap­i­tal. James Collins, the MIT pro­fes­sor and co-found­ing fac­ul­ty mem­ber at the Wyss In­sti­tute, is al­so join­ing the board, as is Samuel Broder, who was ap­point­ed as the NCI chief by for­mer Pres­i­dent Ronald Rea­gan.

coverage

• 'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

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In the largest biotech SPAC deal to clear the hur­dles to Nas­daq, the biotech that en­vi­sioned every­thing from re­mak­ing syn­thet­ic meat to a whole new ap­proach to de­vel­op­ing drugs has joined forces with one of the biggest dis­rup­tors in the in­dus­try. Gink­go struck a deal to go pub­lic in a leviathan SPAC that sets its pre-mon­ey val­u­a­tion at $15 bil­lion. Sloan’s Ea­gle Eq­ui­ty Part­ners co-spon­sored the trans­ac­tion with Bell­co Cap­i­tal, led by Arie Bellde­grun, a high-fly­ing biotech in­vestor in the 4 years since he sold Kite to Gilead for $12 bil­lion. Bellde­grun has be­come an en­thu­si­as­tic cham­pi­on of the Gink­go founders, who launched the com­pa­ny 13 years ago. Gink­go will use their new wind­fall for more than just the field, though. In ad­di­tion to com­par­ing the biotech to Mi­crosoft, CEO Ja­son Kel­ly of­ten likens Gink­go to Ama­zon Web Ser­vices, pro­vid­ing ge­net­ic en­gi­neer­ing and oth­er lab ser­vices to both star­tups and larg­er com­pa­nies. As such, they re­ly on economies of scale; the cost of en­gi­neer­ing a giv­en cell falls as they en­gi­neer more cells. So far they’ve been tripling ca­pac­i­ty and halv­ing costs each year. They now plan to add more fa­cil­i­ties, while of­fer­ing ad­ja­cent ser­vices, such as da­ta or man­u­fac­tur­ing, to help com­pa­nies that use their plat­form.

coverage

• From base­ment lab to Wall Street: Ab­sci looks to bring its 'pro­tein print­ing' plat­form pub­lic
• Say good­bye to plants: Syn­bio play­er An­theia earns new back­ers in quest to re­design flo­ra-de­rived med­i­cine man­u­fac­tur­ing
• No­vo Nordisk to re­search oral obe­si­ty treat­ment; Dana-Far­ber taps in­to Har­bour Bio­Med's mice plat­form in mul­ti­year deal

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As the Covid-19 pan­dem­ic made con­ven­tion­al tri­als im­pos­si­ble for some drug­mak­ers, more and more com­pa­nies moved to de­cen­tral­ize their clin­i­cal stud­ies, ac­cel­er­at­ing busi­ness for tech de­vel­op­ers like Sci­ence 37. Lever­ag­ing that boost, the com­pa­ny went pub­lic on the backs of a SPAC merg­er and earned a uni­corn val­u­a­tion. The com­pa­ny got its start back in 2014 and struck a part­ner­ship with No­var­tis four years lat­er to launch 10 vir­tu­al clin­i­cal tri­als in which pa­tients could par­tic­i­pate via cell phone. The sys­tem can cap­ture and gen­er­ate da­ta from things like elec­tron­ic clin­i­cal out­comes as­sess­ments, eCon­sent and re­al-world ev­i­dence. It em­ploys the help of not on­ly de­vices, but al­so telemed­i­cine in­ves­ti­ga­tors, mo­bile nurs­es and re­mote co­or­di­na­tors. Ac­cord­ing to a re­port Sci­ence 37 con­duct­ed it­self, CEO David Co­man said more than 80% of bio­phar­ma com­pa­nies plan on con­duct­ing a clin­i­cal tri­al us­ing at least some de­cen­tral­ized el­e­ments this year, and near­ly 60% don’t have the in­ter­nal ca­pa­bil­i­ties to do it.

coverage

• Gold­man Sachs backs clin­i­cal tri­al ser­vices in the cloud with $230M eq­ui­ty play amid de­cen­tral­ized study craze
• The dig­i­tal health field con­tin­ues to boom as Soft­Bank-backed start­up hits uni­corn sta­tus in SPAC re­verse merg­er
• Lark­spur Health Ac­qui­si­tion files to go pub­lic as this year's SPAC flood surges over $14B

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Aneb­u­lo Phar­ma­ceu­ti­cals pen­ciled in a mod­est $15 mil­lion for its IPO raise. The Lake­way, TX-based com­pa­ny, found­ed just last year, is fo­cused on de­vel­op­ing treat­ment for cannabi­noid over­dose and sub­stance ad­dic­tion. Aneb­u­lo’s lead can­di­date, ANEB-001, is de­signed to re­verse the neg­a­tive ef­fects of cannabi­noid over­dose with­in one hour of ad­min­is­tra­tion. Aneb­u­lo is hop­ing to ful­ly fi­nance a Phase II proof-of-con­cept study for the pro­gram with its IPO mon­ey. But this won’t be the last time Aneb­u­lo is look­ing to raise mon­ey — in their S-1, they not­ed that they’ll have more cap­i­tal in about 18 months to run the piv­otal safe­ty tri­als, launch the drug com­mer­cial­ly and make mile­stone pay­ments to Ver­nalis, from whom Aneb­u­lo li­censed its pro­gram. Aneb­u­lo set its IPO terms on April 26.

coverage

• Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq
• The End­points 20 un­der 40, biotech's new nor­mal, Stéphane Bancel's one re­gret, and more
• Rain Ther­a­peu­tics head­lines newest slate of IPO-bound biotechs with $100M pen­ciled in for lead on­col­o­gy pro­gram

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Ta­laris re­cent­ly saw a nine-fig­ure raise, com­ing in the form of a $115 mil­lion Se­ries B back in Oc­to­ber. The mis­sion here is to make or­gan trans­plants safer — and po­ten­tial­ly elim­i­nate the need for im­muno­sup­pres­sive drugs — by way of al­lo­gene­ic stem cell ther­a­py. At the time of the Se­ries B, CEO Scott Re­quadt said he saw “dra­mat­ic progress” over the pre­vi­ous 18 months, not­ing Ta­laris had its first Phase III tri­al for the lead FCR001 pro­gram in liv­ing donor kid­ney trans­plant re­cip­i­ents. FCR001 it­self is com­posed of stem and im­mune cells that are pro­cured from a healthy donor, who is al­so the or­gan trans­plant donor. Ta­laris does all its man­u­fac­tur­ing it­self and is then ad­min­is­tered to the pa­tient af­ter “non­mye­loab­la­tive con­di­tion­ing,” ac­cord­ing to the biotech’s S-1. Some of the IPO cash will be fun­neled to­ward the reg­is­tra­tional Phase III for FCR001, while ad­di­tion­al funds will help fur­ther R&D and oth­er tri­als for the pro­gram. There will al­so be some mon­ey ear­marked for the ex­pan­sion of CMC op­er­a­tions to sup­port even­tu­al com­mer­cial­iza­tion of the ap­proved prod­uct, should it get there.

coverage

• Black­stone en­lists a mur­der­ers' row of ad­vi­sors, in­clud­ing ex-Sanofi CEO Olivi­er Brandi­court, to steer life sci­ences biz
• Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq
• News brief­ing: Gy­ro­scope and Ta­laris set IPO terms; FDA grants ex­pand­ed nod to Chiesi's sick­le cell drug

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Orig­i­nal­ly launched out of Stan­ford in late 2019, Jasper’s main fo­cus has been around their an­ti-CD117 an­ti­body, which it’s de­vel­op­ing as a con­di­tion­ing agent for all sorts of stem cell trans­plants in or­der to make the pro­ce­dures safer and more ac­ces­si­ble. The com­pa­ny had re­ceived $35 mil­lion as part of that Se­ries A thanks to the dis­cov­ery of a Stan­ford grad stu­dent show­ing an eas­i­er way to de­plete stem cells in mice be­fore trans­plan­ta­tion. Stan­ford sci­en­tist Ju­dith Shizu­ru then helped turn that dis­cov­ery in­to the an­ti­body around which Jasper has spent so much ef­fort. It al­so led Jasper to see whether or not oth­er com­pa­nies had start­ed look­ing at this type of pro­ce­dure in hu­mans, lead­ing them to a col­lab­o­ra­tion with Am­gen. Rather than us­ing chemother­a­py or ra­di­a­tion to re­move old stem cells, the pro­gram works by re­duc­ing stem cells from with­in their hard-to-reach pock­ets in the bone mar­row. Ear­li­er this year, Jasper’s lead pro­gram JSP191 re­port­ed its pre­lim­i­nary da­ta from an open-la­bel Phase I study, with all six in­di­vid­u­als show­ing suc­cess­ful en­graft­ment of the stem cells in their pro­ce­dures.

coverage

• Cure­Vac gains COO and hands Flo­ri­an von der Mülbe new as­sign­ment in the midst of Covid-19 vac­cine trou­bles; As Ken Fra­zier re­tires, Mer­ck hires chief strat­e­gy of­fi­cer
• FDA lets blue­bird re­sume tri­als for sick­le cell gene ther­a­py af­ter can­cer scare, but big ques­tions linger over field
• Let’s make that $1B-plus: Abing­worth gath­ers more cash, this time for its late-stage pok­er game. And we learned that even a biotech nu­clear win­ter has its ad­van­tages

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Sev­en years af­ter found­ing Roivant Sci­ences as an up­start con­tender in the world of biotech cre­ation, Vivek Ra­maswamy and his re­cent­ly anoint­ed CEO Matt Gline flew in­to Nas­daq on the gild­ed wings of a cash-heavy SPAC. They’ve as­sem­bled a fresh $611 mil­lion in fi­nanc­ing for Roivant — $411 mil­lion held in trust from the in­vestors in MAAC with a fresh $200 mil­lion from the syn­di­cate. The plan to go pub­lic fits square­ly with Gline’s blue­print to firm up and ex­pand a broad set of in­vestors as he goes on to the next chap­ter in Roivant’s ex­is­tence. Roivant got start­ed with Ra­maswamy, how­ev­er, thanks to his phi­los­o­phy that Big Phar­ma was spawn­ing more promis­ing drugs, while leav­ing oth­er op­por­tu­ni­ties on the shelf. It ran in­to some ear­ly head­winds thanks to a stun­ning Alzheimer’s fail, but Ra­maswamy had al­ready boot­ed up a string of star­tups, each de­vot­ed to a par­tic­u­lar sec­tion of the glob­al pipeline. And it’s grown con­sid­er­ably.

coverage

• Mod­er­na dips in­to J&J's tal­ent pool for Tal Zak­s' re­place­ment; Jim Mullen choos­es next chief sci­en­tist at Ed­i­tas Med­i­cine
• Roger Perl­mut­ter’s new gig, Covid-19 IP dra­ma, Vivek Ra­maswamy's coach on the SPAC train, and more
• Vivek Ra­maswamy and Matt Gline swoop in­to Nas­daq on the wings of Jim Mom­tazee's SPAC with a $7B-plus Roivant de­but ready to do some deals

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The British biotech is most fa­mous for cre­at­ing the tech­nol­o­gy be­hind the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine, with its co-founder Sarah Gilbert hav­ing head­ed up that re­search. Vac­citech’s push to go pub­lic came just a cou­ple of weeks af­ter rais­ing an im­pres­sive $168 mil­lion for a Se­ries B round, led by Lon­don in­vest­ment firm M&G and joined by Gilead and Ten­cent, among oth­ers. Con­cerns have arisen over the As­traZeneca shot due to a rare side ef­fect of blood clots in younger re­cip­i­ents, how­ev­er, which may lim­it some of the op­ti­mism sur­round­ing the biotech. The EMA and MHRA have both re­quest­ed that clots be list­ed as a very rare po­ten­tial risk to the vac­cine, though they not­ed the ben­e­fits of get­ting the shot con­tin­ue to out­weigh those risks. Vac­citech not­ed these con­cerns in its S-1 “risk fac­tor” sec­tion, writ­ing that in ad­di­tion to the pos­i­tive risk-ben­e­fit pro­file of the vac­cine, “there can be no as­sur­ance that the vac­cine is not as­so­ci­at­ed with an in­crease in the over­all risk of throm­boem­bol­ic events.” As­traZeneca al­so paused its vac­cine tri­al in chil­dren as the clot­ting wor­ries con­tin­ued. Vac­citech set its terms on April 26.

coverage

• Qui­et end for flashy up­start, the PD-(L)1 reck­on­ing that was­n't, Big Phar­ma's Covid-19 year, and more
• Bio­gen won’t ex­plain why FDA slapped down their bid for new Tysabri for­mu­la­tion
• The com­pa­ny be­hind As­traZeneca's Covid-19 vac­cine just went pub­lic, weeks af­ter com­plet­ing mon­ster Se­ries B, as Were­wolf al­so makes the Nas­daq leap

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Boston-based Were­wolf out­lined some of its plans to hit the clin­ic back in Jan­u­ary, when CEO Dan Hick­lin took the wraps off a $72 mil­lion Se­ries B. Us­ing an en­gi­neer­ing plat­form dubbed PREDA­TOR, the com­pa­ny has three mol­e­cules be­long­ing to a class they dub In­dukines, which com­pris­es four com­po­nents: a cy­tokine, an in­ac­ti­va­tion do­main, a half-life ex­ten­sion do­main and a link­er that can be cleaved by pro­teas­es found in tu­mors. That way, they rea­son, the drug stays qui­et through­out the body and on­ly trig­gers an in­flam­ma­to­ry ef­fect against can­cer. The sys­tem makes use of tech­nolo­gies from Har­poon — a fel­low MPM com­pa­ny — in­clud­ing “polypep­tides and a bind­ing moi­ety for con­di­tion­al ac­ti­va­tion of cer­tain polypep­tides.” In ad­di­tion to promis­ing roy­al­ties and ex­chang­ing cer­tain oth­er patent rights, Were­wolf paid a grand $500,000 up­front to Har­poon, which is build­ing an op­er­a­tion around T cell en­gage­ment. With an ini­tial fo­cus on IL-2 and IL-12, Were­wolf is look­ing to be­gin hu­man test­ing for WTX-124 and WTX-330 in 2022. The third can­di­date aims to con­di­tion­al­ly ac­ti­vate IFN-a.

coverage

• Mod­er­na dips in­to J&J's tal­ent pool for Tal Zak­s' re­place­ment; Jim Mullen choos­es next chief sci­en­tist at Ed­i­tas Med­i­cine
• The com­pa­ny be­hind As­traZeneca's Covid-19 vac­cine just went pub­lic, weeks af­ter com­plet­ing mon­ster Se­ries B, as Were­wolf al­so makes the Nas­daq leap
• Ex-Vi­vid­ion chief Diego Mi­ralles finds 'dream team' at stealthy Flag­ship port­fo­lio com­pa­ny; Astel­las looks in­ward to se­lect CBO and CSO

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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.

coverage

• A pair of biotechs pre­pares to hit Nas­daq, as to­tal 2021 IPO raise quick­ly ap­proach­es $3B

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Rain Ther­a­peu­tics saw a show­er of good for­tune in 2020. Around La­bor Day last year, the biotech tripled its pipeline in the span of a week, li­cens­ing a re­search pro­gram from Drex­el Uni­ver­si­ty and nab­bing a Phase II-ready drug from Dai­ichi Sankyo. Rain fol­lowed that up with a $63 mil­lion fundraise short­ly af­ter to push for­ward all three of its pro­grams. The Dai­ichi pro­gram has now be­come Rain’s lead. Dubbed RAIN-32, the can­di­date will see the bulk of Rain’s IPO funds fun­neled to­ward it. Per the S-1, Rain plans to launch three stud­ies for RAIN-32, in­clud­ing a piv­otal Phase III study in an MDM2-am­pli­fied sub­type of li­posar­co­ma. The new­er can­di­dates pair up with the com­pa­ny’s orig­i­nal mis­sion, one which helped it launch with an $18 mil­lion Se­ries A back in 2018. Rain’s first ex­per­i­men­tal drug was tar­lox­o­tinib, a small mol­e­cule in­hibitor de­signed to tar­get low oxy­gen lev­els in tu­mors, there­by spar­ing healthy tis­sues.

coverage

• With Glax­o­SmithK­line in the rearview mir­ror, Ab­bas Hus­sain is ready to lead a biotech of his own; Doug Tre­co scores first CEO job since Ra Phar­ma buy­out
• CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ex­ecs af­ter An­toine Yver's ap­point­ment
• April show­ers bring more biotechs to Nas­daq, as Rain and Im­pel bump 2021's to­tal raise above $6B

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More than two years af­ter its crossover raise, Im­pel Neu­roPhar­ma is fi­nal­ly head­ing to Nas­daq. The Seat­tle-based biotech has a unique ap­proach for get­ting CNS drugs de­liv­ered to the brain — through the nose. Im­pel’s tech is cen­tered around a de­liv­ery sys­tem of nasal dos­es of old and thor­ough­ly un­der­stood drugs, with re­search go­ing to­ward mi­graines, Parkin­son’s and ag­i­ta­tion re­lat­ed to autism. Led by CEO Adri­an Adams, Im­pel hopes an en­hanced nasal de­liv­ery ap­proach can im­prove a drug’s per­for­mance, of­fer­ing an open­ing for an im­proved ther­a­peu­tic ef­fect with a liq­uid or dry for­mu­la­tion of an old drug. Their mi­graine pro­gram has com­plet­ed its piv­otal study, with an ex­pect­ed PDU­FA date of Sept. 6 lat­er this year. As such, the ma­jor­i­ty of the planned IPO cash will go to­ward fund­ing the po­ten­tial com­mer­cial launch of the mi­graine treat­ment, which Im­pel plans to mar­ket as Trud­he­sa. The drug is an up­per nasal for­mu­la­tion of di­hy­droer­go­t­a­mine to treat acute mi­graines. The re­main­der of the IPO funds will help the INP105 pro­gram, de­signed for acute treat­ment of ag­i­ta­tion and ag­gres­sion as­so­ci­at­ed with autism spec­trum dis­or­der. This can­di­date is a nasal re­for­mu­la­tion of olan­za­p­ine.

coverage

• April show­ers bring more biotechs to Nas­daq, as Rain and Im­pel bump 2021's to­tal raise above $6B
• The End­points 20 un­der 40, biotech's new nor­mal, Stéphane Bancel's one re­gret, and more
• Min­eralys emerges with a new take on an old idea for the treat­ment of hy­per­ten­sion and $40M to play with

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Zymer­gen’s IPO pitch comes five years af­ter the syn­thet­ic bi­ol­o­gy com­pa­ny raised $174 mil­lion from in­vestors by piquing in­ter­est in de­sign­er mi­crobes. The com­pa­ny so far has spe­cial­ized in en­gi­neer­ing mi­crobes for new ma­te­ri­als, in­clud­ing elec­tron­ics and in­sect re­pel­lent, or for man­u­fac­tur­ing chem­i­cals and fu­els. But they’ve al­so qui­et­ly been in­volved in drug de­vel­op­ment and man­u­fac­tur­ing bi­o­log­ics. Their IPO haul, which could be sig­nif­i­cant, rep­re­sents a ma­jor mile­stone for a syn­thet­ic bi­ol­o­gy field that has been try­ing to re­make cor­ners of the bio­phar­ma in­dus­try. The amount they ul­ti­mate­ly raise could pro­vide a bench­mark for the next wide­ly an­tic­i­pat­ed syn­thet­ic bi­ol­o­gy IPO: Gink­go Bioworks, which has played a much more di­rect role in drug de­vel­op­ment, team­ing with Roche, Mod­er­na and Syn­log­ic. Zymer­gen has yet to make any ma­jor pub­lic in­roads in­to bio­phar­ma, but they say on their web­site in a sec­tion la­beled “emerg­ing ar­eas” that they are ac­tive­ly us­ing their ge­net­ic li­braries, high-through­put sys­tems and oth­er tech­nolo­gies to de­vel­op drugs for on­col­o­gy and in­fec­tious dis­eases. Their first prod­uct, a film that al­lows cus­tomers to make fold­able touch­screens, was launched in De­cem­ber 2020.

coverage

• From cel­list to syn­thet­ic cell-ist: Jef­frey Kim scores $23M to reimag­ine blood tests, cell ther­a­py
• From base­ment lab to Wall Street: Ab­sci looks to bring its 'pro­tein print­ing' plat­form pub­lic
• Say good­bye to plants: Syn­bio play­er An­theia earns new back­ers in quest to re­design flo­ra-de­rived med­i­cine man­u­fac­tur­ing

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Re­cur­sion’s $239 mil­lion Se­ries D marked one of the largest, if not the sin­gle largest, fund­ing rounds for an ar­ti­fi­cial-in­tel­li­gence-fo­cused biotech. That ap­proach cen­ters around a 100,000 square-foot ware­house in down­town Salt Lake City, where ro­bots take Petri dish­es of dif­fer­ent cell types and knock out dif­fer­ent genes. They’re con­stant­ly tak­ing pic­tures in the process, with the dif­fer­ences be­ing too small for a hu­man eye to dif­fer­en­ti­ate. But their com­put­ers can, and by do­ing so pick up pat­terns to in­di­cate what can make a cell sick and which genes, when tar­get­ed, can make them healthy. With­in its S-1, Re­cur­sion sig­naled a broad de­vel­op­ment push across its pipeline. The biotech plans to fo­cus the funds on Phase II tri­als for four of its pro­grams: REC-4881 for fa­mil­ial ade­no­ma­tous poly­po­sis, REC-3599 for GM2 gan­gliosi­do­sis, REC-2282 for neu­rofi­bro­mato­sis type 2 and REC-994 for cere­bral cav­ernous mal­for­ma­tion. There are al­so plans to use some of the mon­ey on six of the biotech’s pre­clin­i­cal can­di­dates, in­clud­ing Bat­ten dis­ease, sol­id and hema­to­log­i­cal ma­lig­nan­cies and the lead mol­e­cule for the treat­ment of C. dif­fi­cile col­i­tis.

coverage

• A Re­cur­sion vet­er­an is map­ping plant life to chart a course to new ther­a­pies — and in­vestors like what they see
• Re­cur­sion will take its AI plat­form pub­lic in lat­est IPO fil­ing, while rare heart mu­ta­tion biotech jumps on SPAC train
• Black­Rock push­es Ex­sci­en­tia Se­ries C to $100M as AI biotech boom con­tin­ues

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Bio­mea is work­ing on small mol­e­cules for ge­net­i­cal­ly de­fined can­cers, but with a twist — they want their drugs to be ir­re­versible. As the com­pa­ny lays out in its S-1, an ir­re­versible small mol­e­cule is a syn­thet­ic com­pound that forms a per­ma­nent bond to its tar­get pro­tein. The idea here is to in­duce greater tar­get se­lec­tiv­i­ty, low­er drug ex­po­sure and pro­vide a much more durable re­sponse than typ­i­cal small mol­e­cules. Bio­mea is fo­cus­ing sole­ly on its lead pro­gram, known as BMF-219. The can­di­date comes from the biotech’s ir­re­versible small mol­e­cule plat­form and is aimed at in­hibit­ing menin in menin-de­pen­dent can­cers. BMF-219 hasn’t hit the clin­ic yet, but Bio­mea is hop­ing to file an IND at some point in the sec­ond half of 2021. The S-1 ex­pands on how Bio­mea plans to get there. About $80 mil­lion to $90 mil­lion of the raise will go to­ward the BMF-219 pro­gram, in­clud­ing the IND-en­abling stud­ies as well as a planned Phase I/II tri­al. An­oth­er $40 mil­lion to $45 mil­lion is slat­ed for R&D for two ad­di­tion­al undis­closed pro­grams.

coverage

• Biotech's IPO raise ap­proach­es $5.5B as Nas­daq con­tin­ues to prove fruit­ful with 2 de­buts and three new fil­ings

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Sur­ro­zon said on April 15 that it plans to re­verse-merge with Con­so­nance Cap­i­tal Man­age­ment’s SPAC in a $212 mil­lion deal, which in­cludes $92 mil­lion from the shell com­pa­ny and $120 mil­lion in PIPE fi­nanc­ing. The com­pa­ny is work­ing on a pipeline of ex­per­i­men­tal drugs that mod­u­late the Wnt path­way, which plays a role in the main­te­nance and self-re­new­al of stem cells in a va­ri­ety of tis­sues. Prod­ucts that af­fect Wnt sig­nal­ing, whose name com­bines Wing­less and Int-1, can be dif­fi­cult to man­u­fac­ture be­cause the process is high­ly un­sta­ble. The goal, then, is to de­vel­op drugs that are flex­i­ble enough to ad­dress in­suf­fi­cient en­doge­nous Wnt or in­suf­fi­cient re­cep­tors that have the po­ten­tial to re­pair dam­aged tis­sue. So far, that’s tak­en the form of two lead pro­grams, one for in­flam­ma­to­ry bow­el dis­ease and an­oth­er to treat se­vere al­co­holic he­pati­tis. Sur­rozen is hop­ing to uti­lize the two Wnt mod­u­lat­ing plat­forms that helped cre­ate these com­pounds to ex­pand in­to oth­er dis­eases, such as those in the eye, lung, kid­ney, cochlea, skin, pan­creas and cen­tral ner­vous sys­tem.

coverage

• A Mubadala-backed biotech is us­ing pa­tient tu­mor tis­sue grown in a petri dish to change pre­ci­sion on­col­o­gy
• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

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Tan­go Ther­a­peu­tics and its CRISPR-fo­cused search for new can­cer genes is re­verse merg­ing with Box­er Cap­i­tal’s blank-check com­pa­ny, the com­pa­ny an­nounced April 14. CEO Bar­bara We­ber told End­points News that Tan­go had been plan­ning for a tra­di­tion­al IPO at some point this year, but they shift­ed gears when Box­er, who had pre­vi­ous­ly led the com­pa­ny’s Se­ries B in April 2020, ap­proached Tan­go ex­ecs with the SPAC idea. The biotech takes ad­van­tage of CRISPR as a re­search tool, us­ing it to dis­cov­er gene pair tar­gets that cre­ate unique vul­ner­a­bil­i­ties in can­cer cells. It’s sim­i­lar to the un­der­ly­ing the­o­ry be­hind PARP in­hibitors — drugs that go af­ter a pro­tein in pa­tients with a mu­ta­tion on one of the pro­teins used to re­pair DNA. Tan­go has three pro­grams it in­tends to ad­vance with Wednes­day’s funds, look­ing to file INDs in each of the next three years..

coverage

• Mod­er­na dips in­to J&J's tal­ent pool for Tal Zak­s' re­place­ment; Jim Mullen choos­es next chief sci­en­tist at Ed­i­tas Med­i­cine
• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

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De­spite its UK deal to sup­ply Covid-19 vac­cines, Val­ne­va is wary of ex­port ten­sions be­tween Britain and the EU slow­ing down de­liv­ery times. The biotech high­light­ed the po­ten­tial risk that’s been in the news re­cent­ly, not­ing in its S-1 that ex­port re­stric­tions may af­fect its abil­i­ty to de­liv­er those shots promised to the UK. Val­ne­va has com­mit­ments to de­liv­er 100 mil­lion vac­cines to Britain by 2022, with the UK own­ing ad­di­tion­al op­tions for an­oth­er 90 mil­lion in sup­ply be­tween 2023 and 2025. They haven’t opt­ed-in just yet, but thanks to Brex­it, Val­ne­va said any lim­its on im­ports or ex­ports may pose a “sub­stan­tial” risk as the shots are man­u­fac­tured in the UK but pack­aged in the EU. The com­pa­ny it­self is head­quar­tered across the Eng­lish chan­nel in Saint-Herblain, France. The April 9 fil­ing comes just a few days af­ter the biotech re­port­ed new pos­i­tive vac­cine da­ta from a Phase I/II tri­al, and a Phase III could be­gin as soon as the end of the month. Val­ne­va test­ed three dos­ing lev­els, and like many oth­er Covid-19 shots be­ing test­ed or au­tho­rized, it was ad­min­is­tered in two jabs three weeks apart. It’s al­so work­ing on a Ly­me dis­ease vac­cine with Pfiz­er, hav­ing launched a Phase II study for that can­di­date in March. Val­ne­va set its terms on April 29.

coverage

• Covid-19 roundup: Zy­dus Cadi­la sub­mits 3-dose vac­cine for reg­u­la­to­ry ap­proval; US do­nates Mod­er­na jabs to Pak­istan dur­ing short­age
• CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ex­ecs af­ter An­toine Yver's ap­point­ment
• Keytru­da gets ac­cel­er­at­ed OK in HER2-pos­i­tive gas­tric can­cer; Twin­Strand gets $50M to hunt for 'nee­dles in a haystack'

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Backed by No­vo Ven­tures and Abing­worth, Re­neo had enough cash be­fore­hand to take them through the com­ple­tion of three ear­ly- to mid-stage tri­als for their lead pro­gram, REN001, CEO Gre­go­ry Flesh­er told End­points at the time. With­in its S-1, Re­neo has now de­tailed its plans to use the IPO funds to com­plete those stud­ies in pri­ma­ry mi­to­chon­dr­i­al my­opathies, fat­ty acid ox­i­da­tion dis­or­ders and McAr­dle dis­ease. REN001 is a PPAR-delta ag­o­nist, and the three con­di­tions Re­neo is look­ing at are re­lat­ed to dif­fer­ent parts of mi­to­chon­dr­i­al func­tion. A once-dai­ly pill, REN001 has the abil­i­ty to help cells ex­press cer­tain genes with­in the mi­to­chon­dria that in­crease a pa­tient’s me­tab­o­lism. Though it’s not a gene ther­a­py, the ul­ti­mate goal is to help pa­tients re­plen­ish mi­to­chon­dria cells once old ones die off while si­mul­ta­ne­ous­ly boost­ing en­zyme pro­duc­tion.

coverage

• IPO mar­ket con­tin­ues to churn with a pair of Covid-19 biotechs seek­ing Nas­daq, while mi­to­chon­dria-fo­cused Re­neo de­buts
• Mer­ck keeps it in the fam­i­ly as Robert Davis hands the CFO keys to Car­o­line Litch­field; Gilead los­es Di­ana Brainard, with vi­rol­o­gy ex­ec be­com­ing CEO of AlloVir
• Gone away are the blue­bird ex­ecs as COO, CMO both leave the nest; Mike Nal­ly is lat­est ma­jor fig­ure to move on from Mer­ck

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Lu­ca Santarel­li tells a straight­for­ward sto­ry about Vec­tivBio. Af­ter sell­ing Ther­a­chon to Pfiz­er in an $810 mil­lion deal, the Roche vet im­me­di­ate­ly spun out with the new com­pa­ny, tak­ing their Phase II drug apraglu­tide for short bow­el syn­drome. The IPO was a nat­ur­al next step on the heels of a mega-raise of $110 mil­lion an­nounced last Oc­to­ber, with the fo­cus still square­ly on ex­e­cut­ing the Phase III and lay­ing the foun­da­tion for com­mer­cial­iza­tion work. A long-act­ing syn­thet­ic pep­tide ana­log of GLP-2, apraglu­tide re­mains the sole as­set in the com­pa­ny and will be de­ployed in a range of rare gas­troin­testi­nal dis­or­ders out­side of SBS. Topline re­sults for the lead in­di­ca­tion, in SBS in­testi­nal fail­ure, are ex­pect­ed in 2023. While Vec­tivBio is look­ing to in-li­cense or ac­quire ad­di­tion­al drugs for the pipeline, the IPO pro­ceeds are most­ly go­ing to­ward the core pro­gram — in­clud­ing a Phase II tar­get­ing a sub­group of SBS-IF pa­tients with colon-in-con­ti­nu­ity anato­my and proof of con­cept in apraglu­tide’s util­i­ty for gas­troin­testi­nal man­i­fes­ta­tions of graft-ver­sus-host dis­ease.

coverage

• Re­cur­sion CSO heads west for mi­ni-brain up­start; No­var­tis vet steps up to the plate as CFO for An­drew Hirsch at C4 Ther­a­peu­tics
• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• The End­points 20 un­der 40, biotech's new nor­mal, Stéphane Bancel's one re­gret, and more

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Bet­ter Ther­a­peu­tics an­nounced its in­ten­tion to go pub­lic via SPAC on April 7. The com­pa­ny fo­cus­es on de­liv­er­ing cog­ni­tive be­hav­ioral ther­a­py to ad­dress the root caus­es of car­diometa­bol­ic dis­eases, and is plan­ning to merge with the SPAC put to­geth­er by Far­al­lon Cap­i­tal Man­age­ment, RS In­vest­ments, Sec­toral As­set Man­age­ment, Monashee In­vest­ment Man­age­ment and oth­er undis­closed in­vestors. The SPAC it­self held rough­ly $56 mil­lion, while Bet­ter al­so got $50 mil­lion in PIPE fi­nanc­ing. Pro­ceeds of the merg­er will be used to ad­vance their lead prod­uct for the treat­ment of type 2 di­a­betes, BT-001, to mar­ket­ing au­tho­riza­tion by the FDA and ad­vance their pipeline of pre­scrip­tion dig­i­tal ther­a­peu­tics for a range of car­diometa­bol­ic dis­eases, Bet­ter said.

coverage

• An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans
• Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er
• It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

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Eli Cas­din and Kei­th Meis­ter’s third SPAC hopped to Nas­daq with a mas­sive $552 mil­lion haul and priced April 7. The Cas­din and Meis­ter ef­fort, known as CM Life Sci­ences III, came just a few weeks af­ter their sec­ond SPAC an­nounced its in­tent to merge with So­ma­Log­ic, one of a num­ber of pro­teomics biotechs look­ing to un­der­stand the hu­man body by look­ing at pro­teins rather than DNA and RNA. That deal net­ted the com­pa­ny a val­u­a­tion north of $1.2 bil­lion. Cas­din and Meis­ter have gone all in on SPACs since the sum­mer of 2020. Since the an­nounce­ment of their first SPAC back in Sep­tem­ber, the pair have merged their first two SPACs with So­ma­Log­ic and Se­ma4.

coverage

• Eli Cas­din and Kei­th Meis­ter dive back in­to the SPAC well with $480M haul just weeks af­ter So­ma­Log­ic re­verse merg­er

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Oleg Nodel­man’s sec­ond hold­ing com­pa­ny de­buted with a $150 mil­lion raise on April 7. Panacea II is the sec­ond blank check com­pa­ny to go pub­lic since his Ecor1 firm launched its first in June 2020. The shell found a part­ner quite quick­ly, agree­ing to take David Hung’s Nu­va­tion Bio pub­lic in Oc­to­ber of that year, with the pair com­plet­ing their merg­er in Feb­ru­ary 2021.

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Achilles pulled in a $175.5 mil­lion raise to take its T cell ther­a­pies tar­get­ing clon­al neoanti­gens to Nas­daq. Co-found­ed by Char­lie Swan­ton of the Fran­cis Crick In­sti­tute, the UK biotech aims to lever­age heavy se­quenc­ing to iden­ti­fy a pa­tient-spe­cif­ic set of tu­mor mu­ta­tions that it can tar­get. Un­like oth­er neoanti­gen pi­o­neers like Grit­stone On­col­o­gy, Neon Ther­a­peu­tics and BioN­Tech, Achilles is look­ing to di­rect­ly de­liv­er can­cer killing T cells rather than stim­u­lat­ing an im­mune re­sponse via a vac­cine. Achilles got a boost in Sep­tem­ber 2019 with a $121 mil­lion Se­ries B thanks to a syn­di­cate led by RA Cap­i­tal. And in No­vem­ber 2020, the biotech pulled in an­oth­er $69.7 mil­lion for an over­sub­scribed Se­ries C.

coverage

• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• Bausch Health sells off Amoun for $740M; Achilles de­buts on Nas­daq with $175.5M IPO
• Alk­er­mes pro­motes from with­in to find new CFO and COO in re­bound ef­fort; Mod­er­na vet Robert Dol­s­ki joins Check­mate as CFO

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Eli Cas­din and Kei­th Meis­ter’s sec­ond SPAC, CM Life Sci­ences II, an­nounced its in­tent to merge with So­ma­Log­ic in late March. The Boul­der, CO-based com­pa­ny is one of a num­ber of biotechs look­ing to un­der­stand the hu­man body by look­ing at pro­teins, rather than DNA and RNA, and the deal comes just three months af­ter the com­pa­ny’s Se­ries A ex­ten­sion. With the merg­er, So­ma­Log­ic can now “dou­ble down” on its strat­e­gy of both col­lect­ing pro­teom­ic da­ta and cre­at­ing ap­pli­ca­tions for clin­i­cal tri­als us­ing that da­ta, CEO Roy Smythe told End­points at the time. The com­pa­ny says it has a to­tal of 20 val­i­dat­ed test­ing tools, known as So­maSig­nal, with an­oth­er 100 or so in de­vel­op­ment.

coverage

• An­oth­er life sci­ences SPAC has popped up from a small biotech CEO with the help of Take­da, No­var­tis vet­er­ans
• Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er
• It takes two to Tan­go: The biotech us­ing CRISPR to dis­cov­er new can­cer gene tar­gets rides a $353M SPAC deal to Nas­daq

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Based out of Boston, Ike­na got start­ed with a $49 mil­lion Se­ries A back in 2017, pulling in funds from high-pro­file back­ers like Or­biMed and At­las Ven­tures to ad­vance its im­munome­tab­o­lism ther­a­pies to treat can­cer. The idea is to lever­age meta­bol­ic path­ways and the bro­ken-down mol­e­cules that re­sult from the body’s me­tab­o­lism in­to sup­press­ing the body’s im­mune sys­tem. Ike­na’s lead in-house pro­gram is IK-930, an oral small mol­e­cule in­hibitor of a tran­scrip­tion fac­tor known as TEAD, or the tran­scrip­tion­al en­hanced as­so­ciate do­main. It deals with Hip­po path­way mu­ta­tions, with Ike­na hop­ing the can­di­date can help reg­u­late po­lar­i­ty, pro­lif­er­a­tion and tis­sue home­osta­sis, among oth­er things, in sol­id tu­mors. They’re hop­ing to sub­mit an IND here in the sec­ond half of 2021. There’s al­so two BMS-part­nered pro­grams deal­ing with TDO and IDO, al­though in­di­rect­ly. BMS owns a rough­ly 8% stake in the com­pa­ny af­ter Cel­gene teamed up with then-Kyn Ther­a­peu­tics in ear­ly 2019.

coverage

• Lega­cies: 60 bio­phar­ma pi­o­neers over 60 who helped birth a tech rev­o­lu­tion in the mak­ing
• No­vavax CFO Greg Covi­no makes a quick ex­it as lead­er­ship carousel keeps turn­ing; Kite ex­ecs fly away to a cell ther­a­py up­start team­ing up with Lyell
• As­traZeneca's Covid-19 vac­cine woes, Mon­cef Slaoui re­signs over sex­u­al ha­rass­ment claims, FDA acts tough, and more

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Edge­wise is fo­cus­ing on rare mus­cle dis­or­ders, with am­bi­tions in Duchenne mus­cu­lar dy­s­tro­phy, Beck­er mus­cu­lar dy­s­tro­phy, and limb-gir­dle mus­cu­lar dy­s­tro­phy. Its lead pro­gram is al­ready in the clin­ic. Edge­wise says that EDG-5506 is a small mol­e­cule in­hibitor for fast my­ofiber (type II) myosin de­signed to ad­dress the root cause of dy­s­trophinopathies. It’s cur­rent­ly in a Phase I tri­al for DMD, Beck­er and LGMD and Edge­wise hopes it can lim­it the hy­per­con­trac­tion stress caused by the lack of dy­s­trophin in these dis­eases. About $80 mil­lion of the IPO funds will be fun­neled to­ward this pro­gram to get it through the Phase I study and through the in­ter­im read­out of a Phase II/III study. An ad­di­tion­al $55 mil­lion is ear­marked for the re­search and de­vel­op­ment of three pre­clin­i­cal pro­grams, EDG-6289, EDG-002 and EDG-003. EDG-6289 is list­ed as a mus­cle sta­bi­liz­er, while the oth­er two are billed as mus­cle de­sen­si­tiz­ers.

coverage

• CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ex­ecs af­ter An­toine Yver's ap­point­ment
• Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at Cata­ma­ran Bio, team­ing up again with ex-Dis­arm CEO
• An­oth­er 4 phar­mas make the fa­bled Nas­daq leap, with com­bined raise rapid­ly ap­proach­ing $4.5B

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De­sign se­cured its launch round just over a year ago, and is now tak­ing its Gene­TAC plat­form pub­lic. The San Diego-based biotech fo­cus­es on de­gen­er­a­tive dis­eases linked to nu­cleotide re­peat ex­pan­sions, and is co-found­ed and chaired by Pratik Shah, who pre­vi­ous­ly helped en­gi­neer two mul­ti-bil­lion M&A deals. Shah was CEO of Aus­pex for 2 years be­fore Te­va scooped it up for $3.5 bil­lion in 2015, and he was al­so chair­man at Syn­thorx, which Sanofi bought out for $2.5 bil­lion at the end of 2019. Gene­TAC, short for gene tar­get­ed chimeras, helps De­sign go af­ter what it says are more than 40 de­gen­er­a­tive dis­eases caused by nu­cleotide re­peat ex­pan­sions. The biotech has two pipeline pro­grams thus far, one in Friedre­ich’s atax­ia and one in my­oton­ic dy­s­tro­phy type-1. IPO funds are slat­ed to go to­ward both of these pro­grams, De­sign wrote in its S-1. It es­ti­mates $30 mil­lion is need­ed to take the Friedre­ich’s atax­ia can­di­date through a Phase I tri­al and $35 mil­lion to take the DM1 pro­gram through Phase I. An­oth­er $35 mil­lion will fund a cur­rent­ly undis­closed pro­gram, with the re­main­der of the cash go­ing to­ward gen­er­al R&D and cor­po­rate pur­pos­es.

coverage

• In­ter­cept re­tools C-suite with a pair of new­com­ers; Charles Ryan moves past Alzheimer's flops with an­oth­er CEO chal­lenge
• As­traZeneca's Covid-19 vac­cine woes, Mon­cef Slaoui re­signs over sex­u­al ha­rass­ment claims, FDA acts tough, and more
• An­oth­er 4 phar­mas make the fa­bled Nas­daq leap, with com­bined raise rapid­ly ap­proach­ing $4.5B

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The Ji’an, Jiangxi, Chi­na-based com­pa­ny mar­kets its pro­grams to­ward the el­der­ly in Chi­na with its tra­di­tion­al Chi­nese med­i­cine de­riv­a­tives, with the goal of ad­dress­ing phys­i­cal con­di­tions re­lat­ed to ag­ing as well as their gen­er­al well-be­ing. Found­ed in 2019, Uni­verse boasts 26 reg­is­tra­tions and ap­provals with Chi­nese reg­u­la­tors and sells 13 prod­ucts as of ear­ly March. With­in its F-1, Uni­verse says it’s split­ting the IPO raise in­to four rough­ly equal parts. There is 28% list­ed for up­grad­ing and ex­pand­ing man­u­fac­tur­ing fa­cil­i­ties, 27% for R&D, 24% for mar­ket­ing and 21% for cor­po­rate up­keep.

coverage

• As­traZeneca's Covid-19 vac­cine woes, Mon­cef Slaoui re­signs over sex­u­al ha­rass­ment claims, FDA acts tough, and more
• An­oth­er 4 phar­mas make the fa­bled Nas­daq leap, with com­bined raise rapid­ly ap­proach­ing $4.5B

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La­va de­buted back in May 2018 with a mod­est $18.9 mil­lion to re­search what was then a nascent field: gam­ma delta T cells. They stayed al­most en­tire­ly un­der the radar — not is­su­ing an­oth­er press re­lease for over a year and a half — un­til an­nounc­ing a can­cer bis­pecifics part­ner­ship with J&J’s Janssen in May 2020. A few months lat­er, they re­turned to the ven­ture well with $83 mil­lion in Se­ries C fi­nanc­ing and two pro­grams ready for the clin­ic. With a fo­cus on im­muno-on­col­o­gy, the Dutch-Amer­i­can biotech’s sci­en­tif­ic ap­proach in­volves build­ing bis­pe­cif­ic an­ti­bod­ies that grab a re­cep­tor on gam­ma delta T cells and link it with a par­tic­u­lar pro­tein on the tu­mor, aim­ing to on­ly ac­ti­vate while in the vicin­i­ty of the can­cer. La­va al­so says its ther­a­pies can help in­duce im­mune mem­o­ry of the can­cer, should it ap­pear again, due to gam­ma delta T cells’ sim­i­lar­i­ty to anti­gen-pre­sent­ing cells. The biotech built its re­search on the sci­en­tif­ic dis­cov­er­ies of CSO Hans van der Vli­et, an on­col­o­gist at VU Uni­ver­si­ty Med­ical Cen­ter and Can­cer Cen­ter Am­s­ter­dam.

coverage

• Eight bets in, Spain's Ys­ios of­fi­cial­ly ties a bow around €216M fund
• As­traZeneca's Covid-19 vac­cine woes, Mon­cef Slaoui re­signs over sex­u­al ha­rass­ment claims, FDA acts tough, and more
• Fol­low­ing the flow of the biotech in­dus­try, La­va heads to Nas­daq with a gam­ma delta T cell promise

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The sec­ond SPAC from Glen­view Cap­i­tal has closed a $600 mil­lion raise for its shell com­pa­ny, pric­ing on March 24. Its syn­di­cate in­cludes the firm’s founder Lar­ry Rob­bins and part­ner John Rodin, who is the SPAC’s CEO.

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This is the sec­ond of three SPACs launched by Vin­od Khosla, mak­ing up $400 mil­lion out of a $1.2 bil­lion play. At the time he filed his SEC pa­per­work, Khosla wrote a brief but polem­i­cal let­ter on the im­por­tance of star­tups and rein­ven­tion, giv­ing on­ly vague hints at what he may be tar­get­ing with his shell com­pa­nies. Still, that let­ter gives ref­er­ence to CRISPR Cas9, ear­ly de­tec­tion of Alzheimer’s and de­men­tia, Genen­tech, and how the in­creas­ing use of AI could help turn the “prac­tice of med­i­cine” to the “sci­ence of med­i­cine” — no­table in­clu­sions for a tech firm that has in re­cent years in­creas­ing­ly wad­ed in­to biotech. This SPAC priced on March 24.

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This is the third of three SPACs launched by Vin­od Khosla, mak­ing up $500 mil­lion out of a $1.2 bil­lion play. At the time he filed his SEC pa­per­work, Khosla wrote a brief but polem­i­cal let­ter on the im­por­tance of star­tups and rein­ven­tion, giv­ing on­ly vague hints at what he may be tar­get­ing with his shell com­pa­nies. Still, that let­ter gives ref­er­ence to CRISPR Cas9, ear­ly de­tec­tion of Alzheimer’s and de­men­tia, Genen­tech, and how the in­creas­ing use of AI could help turn the “prac­tice of med­i­cine” to the “sci­ence of med­i­cine” — no­table in­clu­sions for a tech firm that has in re­cent years in­creas­ing­ly wad­ed in­to biotech. This SPAC priced on March 24.

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Three days af­ter RA Cap­i­tal founder Pe­ter Kolchin­sky steered his first SPAC in­to a $300 mil­lion raise for Point Bio­phar­ma’s late-stage ra­dio­phar­ma­ceu­ti­cals play, he teed up a new one. This new SPAC raised $130 mil­lion and priced March 18. The SPAC deal with Point com­bined Kolchin­sky’s trust of $135 mil­lion along with a $165 mil­lion of­fer­ing with a slate of high-pro­file in­vestors buy­ing in­to new shares: John­son & John­son In­no­va­tion – JJDC, Inc., Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Far­al­lon Cap­i­tal Man­age­ment, LLC, BVF Part­ners LP, Box­er Cap­i­tal, Sphera Health­care, Wood­line Part­ners LP, Su­vret­ta Cap­i­tal, Fair­mount Funds, and Per­cep­tive Ad­vi­sors.

coverage

• Top biotech in­vestor Pe­ter Kolchin­sky tees up a new SPAC — 3 days af­ter a $300M raise for ra­dio­phar­ma­ceu­ti­cals play

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Rev­o­lu­tion Health­care Ac­qui­si­tion, the blank check com­pa­ny ARCH formed in part­ner­ship with the tech play­er Gen­er­al Cat­a­lyst, raised the $500 mil­lion it asked for in an IPO. The two firms had made it clear that they will be look­ing to take a dig­i­tal health com­pa­ny pub­lic — with the end goal be­ing part of a par­a­digm shift in­volv­ing “tech­nolo­gies like wear­able sen­sors, re­mote con­tin­u­ous da­ta cap­ture, point of care di­ag­nos­tics, tele­health ca­pa­bil­i­ties and ar­ti­fi­cial in­tel­li­gence/ma­chine learn­ing tools. Men­tal health — an area ARCH co-founder and man­ag­ing di­rec­tor Bob Nelsen has pre­vi­ous­ly said is “at the top of my mind” — will loom large in that search, as will home-based care.

coverage

• Got a rev­o­lu­tion­ary health­care com­pa­ny? Bob Nelsen, Jeff Lei­den’s SPAC has $500M to take it pub­lic

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By div­ing in­to tu­mor-in­fil­trat­ing lym­pho­cytes, In­stil Bio faces some high-pro­file com­pe­ti­tion not just with TIL play­ers like Io­vance, Adap­ti­m­mune and PACT Phar­ma but al­so CAR-T and TCR-T cell ther­a­py de­vel­op­ers like Gilead’s Kite and Bris­tol My­ers Squibb’s Juno. Yet the Dal­las-based biotech is all-in on the tech plat­form, in­clud­ing the man­u­fac­tur­ing know-how, it first in-li­censed then ac­quired from Im­meta­cyte, a Uni­ver­si­ty of Man­ches­ter spin­out that’s been run­ning a com­pas­sion­ate use pro­gram at a UK hos­pi­tal for eight years. Since its found­ing in 2018, it’s raised $380 mil­lion of ven­ture fund­ing to get here, and CEO Bron­son Crouch’s crew ini­tial­ly pen­ciled in an­oth­er $100 mil­lion raise, but that fig­ure was up­sized to $250 mil­lion when In­stil set its IPO terms on March 15. In­stil ul­ti­mate­ly priced at $20 per share with a $320 mil­lion raise. The plan now is to sub­mit an IND to the FDA — its first — and jump straight in­to a Phase II tri­al for melanoma lat­er this year, which In­stil hopes can sup­port a BLA sub­mis­sion as ear­ly as 2023. Giv­en how fre­quent­ly CMC is­sues trip up cell and gene ther­a­pies these days, though, there’s like­ly a long way to go for its in-house man­u­fac­tur­ing crew.

coverage

• Great Danes: Two Nordic biotechs name their chief ex­ec­u­tives; Ax­el Hoos bids adieu to Glax­o­SmithK­line, be­comes CEO of small on­col­o­gy play­er
• Mer­ck­'s C-suite shake­up, Eli Lil­ly stirs fresh Alzheimer's con­tro­very, play by play of Am­gen's $2B buy­out, and more
• The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021

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Found­ed by two old pals whose friend­ship traces back to a uni­ver­si­ty in Guangzhou, Chi­na, Con­nect Bio­phar­ma had snagged $115 mil­lion from a slate of mar­quee in­vestors back in Au­gust. Now, they’re ready to take the com­pa­ny to Nas­daq with a pipeline of im­mune mod­u­la­tors, led by an an­ti-IL-4Ra an­ti­body that can treat in­flam­ma­to­ry al­ler­gic dis­eases such as atopic der­mati­tis, asth­ma, and chron­ic rhi­nos­i­nusi­tis with nasal polyps. These are big in­di­ca­tions chased by some of the top names in the glob­al bio­phar­ma world — the lead drug hits the same tar­get as Re­gen­eron and Sanofi’s Dupix­ent — but Con­nect be­lieves the as­says they used in drug dis­cov­ery could make them a best-in-class con­tender. The big re­veal will come in the sec­ond half of 2021, when topline Phase IIb re­sults are due. For now, the Phase Ib re­sults will have to do, re­sults that showed a four-week treat­ment im­proved skin le­sion and pru­ri­tus in mod­er­ate-to-se­vere atopic der­mati­tis pa­tients. Con­nect set its terms on March 12.

coverage

• Mer­ck­'s C-suite shake­up, Eli Lil­ly stirs fresh Alzheimer's con­tro­very, play by play of Am­gen's $2B buy­out, and more
• The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021
• Four IPOs and a SPAC pitch a new slate of mi­cro­bio­me, can­cer and in­flam­ma­to­ry drugs to Wall Street

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When Mark Smith helped start the non­prof­it stool bank Open­Bio­me in 2012, there weren’t re­li­able, stan­dard­ized ways to man­u­fac­ture and dis­trib­ute stool prepa­ra­tions for fe­cal mi­cro­bio­ta trans­plants. More than eight years lat­er, he be­lieves new al­ter­na­tives are on the hori­zon. Finch Ther­a­peu­tics’ S-1 dropped just days af­ter Open­Bio­me an­nounced it’s phas­ing out pro­duc­tion of new treat­ments, with an aim to save enough in­ven­to­ry to meet de­mand through­out 2021 “as a bridge to FDA-ap­proved ther­a­pies.” The biotech wants to bring one of those ther­a­pies to the mar­ket. CP101, a cap­sule made of freeze-dried stool sam­ples from healthy donors, has hit the mark on re­cur­rence-free bac­te­ria clear­ance for pa­tients with a C. dif­fi­cile in­fec­tion — re­sults that Smith, co-founder and CEO at Finch, said came at a turn­ing point for the field. Af­ter some ear­ly fail­ures and im­plo­sions, sci­en­tists may have found the right way to pack all the ben­e­fits of a fe­cal mi­cro­bio­ta trans­plant (FMT) in­to a pill and skip the cum­ber­some pro­ce­dure. Smith raised $128 mil­lion in the IPO to ac­com­plish this, and a sec­ond, con­fir­ma­to­ry tri­al is ex­pect­ed to be­gin not long af­ter Finch lands on Nas­daq and should read out in 2023. Finch set its terms on March 15.

coverage

• Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at Cata­ma­ran Bio, team­ing up again with ex-Dis­arm CEO
• The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021
• Four IPOs and a SPAC pitch a new slate of mi­cro­bio­me, can­cer and in­flam­ma­to­ry drugs to Wall Street

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Hav­ing sought a rel­a­tive­ly mod­est raise giv­en the run of biotechs over the last year or so to go af­ter hefty IPO cash, Gain raised $40 mil­lion for its pub­lic of­fer­ing. 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. Gain set its terms on March 10.

coverage

• The Ides of March bring no mis­for­tune to biotech, as in­dus­try logs sec­ond-busiest IPO week of 2021
• Af­ter a slow week, the IPO train is back up and run­ning as 3 more biotechs hop aboard
• For­mer Glax­o­SmithK­line CEO An­drew Wit­ty takes the helm at Unit­ed­Health; Af­ter more than a decade, Daniel Chung is back on a fa­mil­iar project

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The SPAC from Tim­o­thy Babich has closed a $250 mil­lion raise for its shell com­pa­ny, pric­ing on March 17. Babich pre­vi­ous­ly found­ed Nexxus Hold­ings, FCM Bank, and Fortelus Cap­i­tal Man­age­ment.

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Ed­uar­do Bra­vo, the Big Phar­ma alum and for­mer CEO of the cell ther­a­py com­pa­ny TiGenix, launched this SPAC and gar­nered a raise of $120 mil­lion. The SPAC rep­re­sents his first ma­jor move since Take­da bought out TiGenix and their off-the-shelf stem cell tech­nol­o­gy for $600 mil­lion in 2018. Join­ing him are two man­ag­ing part­ners from Life Sci­ence Part­ners: Mar­ti­jn Klei­jwegt, who helped build the now Bio­Marin-owned biotech Pros­en­sa and a biotech that lat­er be­came J&J Vac­cines, and Mark Wegter, who is on the board of Kiadis. Bra­vo and LSP’s pitch to in­vestors is that Eu­ro­pean biotechs have been se­vere­ly un­der­val­ued, de­spite the fact that the pace of sci­en­tif­ic re­search and de­vel­op­ment on the con­ti­nent is on par with the pace in the US. The SPAC priced on March 16.

coverage

• Ed­uar­do Bra­vo re­turns to bring Eu­ro­pean biotech in on the SPAC splurge

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The SPAC from Fal­con Edge Cap­i­tal, Pre­sight Cap­i­tal and Ape­iron In­vest­ment Group has closed a $230 mil­lion raise for its shell com­pa­ny, pric­ing on March 11. Its syn­di­cate in­cludes Fal­con Edge’s chair­man Rick Ger­son, and SPAC CEO Chris­t­ian Anger­may­er, who is Pre­sight and Ape­iron’s founder.

coverage

• No­var­tis' wild card block­buster con­tender falls flat; Reg­u­la­to­ry reck­on­ing for check­point drugs looms; and more
• Prometheus and Long­board make the leap to Nas­daq with 9-fig­ure of­fer­ings and are joined by a Fal­con Edge-backed SPAC

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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. Prometheus set its IPO terms on March 8.

coverage

• CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ex­ecs af­ter An­toine Yver's ap­point­ment
• Genen­tech alum Jane Gro­gan goes start­up hop­ping from Ar­se­nal­Bio to Graphite Bio; Scott Holmes to han­dle CFO du­ties at Cata­ma­ran Bio, team­ing up again with ex-Dis­arm CEO
• Prometheus and Long­board make the leap to Nas­daq with 9-fig­ure of­fer­ings and are joined by a Fal­con Edge-backed SPAC

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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. Long­board set terms for its IPO on March 8.

coverage

• Prometheus and Long­board make the leap to Nas­daq with 9-fig­ure of­fer­ings and are joined by a Fal­con Edge-backed SPAC
• Af­ter a slow week, the IPO train is back up and run­ning as 3 more biotechs hop aboard
• Diem Nguyen tapped to lead 'point of in­flec­tion' at Xalud Ther­a­peu­tics; Di­ana Es­co­lar dances her way to Avro­bio CMO

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The SPAC from Kevin Naze­mi has closed a $300 mil­lion raise for its shell com­pa­ny, pric­ing on March 10. Naze­mi cur­rent­ly serves as Part­ner at start­up in­vest­ment and in­cu­ba­tion firm Lob­by 7 Cap­i­tal.

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The SPAC from for­mer Well­Care ex­ecs has closed a $414 mil­lion raise for its shell com­pa­ny, pric­ing on March 2. Its syn­di­cate in­cludes Beau Garv­er­ick, a for­mer se­nior VP at Well­Care Health Plans, and Ken­neth Bur­dick, the firm’s for­mer CEO.

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Per­cep­tive’s Joseph Edel­man is no stranger to the hold­ing com­pa­nies that have now come to dom­i­nate the mar­ket,, as Arya IV priced just a few weeks af­ter Arya III an­nounced its plans to re­verse-merge with Nau­tilus. The VC firm filed Arya IV’s S-1 just one day af­ter that an­nounce­ment, in­di­cat­ing Edel­man is steer­ing a well-oiled SPAC ma­chine with no plans of slow­ing down. Much of that foun­da­tion has os­ten­si­bly been built on­ly over the last 12 months. The first Arya ac­qui­si­tion out­fit went pub­lic in 2018, but didn’t find a part­ner un­til March 2020 when it com­bined with TCR play­er Im­mat­ics. Like its three pre­de­ces­sors, Arya IV is aim­ing to go af­ter biotechs that want to take a quick­er route to Nas­daq than through the tra­di­tion­al IPO route. It raised $130 mil­lion and priced on Feb. 26.

coverage

• Per­cep­tive's fourth — yes, fourth — SPAC jumps to Nas­daq as the blank check tree con­tin­ues to ripen

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The SPAC from PIPV Cap­i­tal has closed a $138 mil­lion raise for its shell com­pa­ny, pric­ing on Feb. 26. Its syn­di­cate in­cludes the firm’s co-founder Os­agie Ima­so­gie, pre­vi­ous­ly the found­ing VP of Glax­o­SmithK­line Ven­tures.

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The SPAC from a for­mer Dis­ney re­sort ex­ec­u­tive has closed a $207 mil­lion raise for its shell com­pa­ny, pric­ing on Feb. 25. Its syn­di­cate in­cludes Allen Weiss, who has been a part­ner at Apol­lo Cap­i­tal Man­age­ment since 2011 and pre­vi­ous­ly served as pres­i­dent of world wide op­er­a­tions for Walt Dis­ney Parks and Re­sorts. The SPAC is run by Robert White­head, who pre­vi­ous­ly co-found­ed and ran Sprout Phar­ma­ceu­ti­cals and Slate Phar­ma­ceu­ti­cals.

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The SPAC from Al­ly Bridge Group has closed a $150.65 mil­lion raise for its shell com­pa­ny, pric­ing on Feb. 17. Its syn­di­cate in­cludes the firm’s founder and CEO Frank Yu.

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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.

coverage

• Eli Lil­ly part­ner Ab­Cellera finds a CBO in the face of bam­lanivimab strug­gles; Fi­bro­Gen's next CSO walks in­to rox­adu­s­tat re­buff
• A pair of Bay­er ex­ecs land pro­mo­tions in the US; En­er­gized by lenzilum­ab da­ta, Hu­mani­gen taps As­traZeneca alum as CMO
• LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

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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.

coverage

• Two months af­ter ink­ing a SPAC deal, Ren­o­va­cor taps new CMO; Cure­Vac reels in a new de­vel­op­ment chief from Mer­ck KGaA
• A pair of biotechs pre­pares to hit Nas­daq, as to­tal 2021 IPO raise quick­ly ap­proach­es $3B
• Ver­sant spin­out lands $80M to go 'much broad­er' than the old Roche part­ner­ship that birthed it

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Se­ma4 is one of a clutch of star­tups that try to com­bine a wide va­ri­ety of bi­o­log­i­cal da­ta and, with ad­vanced an­a­lyt­i­cal tools like AI, turn them in­to in­sights drug de­vel­op­ers can use for dis­cov­er­ing new tar­gets or de­sign­ing new tri­als. They’ve teamed with Sanofi on a five-year dig­i­tal study to bet­ter un­der­stand asth­ma and, late last year, with J&J to iden­ti­fy pa­tients best suit­ed for can­cer tri­als. Found­ed by Er­ic Schadt, a com­pu­ta­tion­al bi­ol­o­gist from Mer­ck and Pa­cif­ic Bio­sciences, Se­ma4 at­tract­ed back­ing from Black­stone, Sec­tion 32 and oth­ers, who have poured over $240 mil­lion in­to the com­pa­ny since 2017. They al­so have a pa­tient-fac­ing side, help­ing run can­cer and re­pro­duc­tive health screens. Through­out the pan­dem­ic, they’ve con­duct­ed thou­sands of Covid-19 sur­veil­lance tests for the state of Con­necti­cut. With cash from a Se­ries C in Ju­ly, they’ve been ex­pand­ing, list­ing dozens of open jobs in bioin­for­mat­ics, lab work, dis­ease dis­cov­ery and even sales. Cas­din Cap­i­tal, hav­ing raised one of the largest ever life sci­ence SPACs, an­nounced its in­tent to merge its first shell cor­po­ra­tion, CM Life Sci­ences I, with Se­ma4 in Feb­ru­ary. The merg­er is ex­pect­ed to close in the sec­ond quar­ter.

coverage

• Great Danes: Two Nordic biotechs name their chief ex­ec­u­tives; Ax­el Hoos bids adieu to Glax­o­SmithK­line, be­comes CEO of small on­col­o­gy play­er
• Mod­er­na dips in­to J&J's tal­ent pool for Tal Zak­s' re­place­ment; Jim Mullen choos­es next chief sci­en­tist at Ed­i­tas Med­i­cine
• Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

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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.

coverage

• Great Danes: Two Nordic biotechs name their chief ex­ec­u­tives; Ax­el Hoos bids adieu to Glax­o­SmithK­line, be­comes CEO of small on­col­o­gy play­er
• The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq
• Boehringer In­gel­heim sharp­ens reti­nal strat­e­gy, scoop­ing up dry AMD drug from a Swiss team be­hind No­var­tis' Beovu

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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.

coverage

• A pair of biotechs pre­pares to hit Nas­daq, as to­tal 2021 IPO raise quick­ly ap­proach­es $3B
• The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq
• News brief­ing: Ab­b­Vie se­lects first tar­get for Drag­on­fly part­ner­ship; Cog­ni­to nets BDD for Alzheimer's treat­ment de­vice

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The SPAC tar­get­ing the health­care sec­tor in Asia has closed a $414 mil­lion raise for its shell com­pa­ny, pric­ing on Feb. 5. Its syn­di­cate in­cludes Ken­neth Hitch­n­er, who spent near­ly three decades at Gold­man Sachs and most re­cent­ly as the CEO of its Asia Pa­cif­ic group, ex­clud­ing Japan. Richard Li is the SPAC’s CEO.

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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.

coverage

• News brief­ing: In­tel­lia hits clin­ic with CRISPR ther­a­py; Vi­for con­tin­ues to spend, pay­ing up to $340M for DGF pro­gram
• 'Ris­ing star' CEO re­counts path from pre-med to break­through meds; Den­dreon taps Big Phar­ma vet Ja­son O'Neill as CEO
• David Chang steps up to CEO spot at WuX­i's cell and gene ther­a­py CD­MO; David Meline is the new CFO at Mod­er­na

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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.

coverage

• What ad­u­canum­ab means for Alzheimer's, un­pack­ing a safe­ty bar­ri­er in CAR-T, the push to up­grade a key ALS tri­al tool, and more
• Gen­mab en­lists an­oth­er an­ti­body con­ju­gate part­ner, team­ing up with Bolt to de­vel­op up to 3 can­cer pro­grams
• The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

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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.

coverage

• PureTech-backed Gele­sis wins biotech's lat­est SPAC deal, plan­ning to bring weight loss prod­uct to up to 150M Amer­i­cans
• J&J, Sid Mukher­jee's Vor team up to pair bis­pecifics with en­gi­neered stem cells for blood can­cer
• Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

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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.

coverage

• Terns Phar­ma­ceu­ti­cals touts safe­ty da­ta from an ex-Eli Lil­ly can­di­date in the hunt for NASH treat­ment
• The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq
• Eli Lil­ly's transpa­cif­ic bo­som bud­dy Terns bags late-round fund­ing to dri­ve NASH hope­fuls through the clin­ic

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Phar­varis is head­ing to 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.

coverage

• UP­DAT­ED: Corey Good­man's ven­Bio clos­es lat­est VC fund — this time to the tune of $550M — with a dozen or more in­vest­ments on deck
• As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign
• Michael Yang leads list of moves at Vi­a­Cyte, suc­ceed­ing Paul Laikind as CEO; Qasim Rizvi named CEO of Take­da part­ner KSQ

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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.

coverage

• Vor leads a new pack of IPOs to price, con­tin­u­ing steady stream of com­pa­nies mak­ing leap to the Nas­daq
• Jeff Capel­lo out the door as Michael Mc­Don­nell takes over Bio­gen's CFO post; Ron Bruehlman named in­ter­im CFO at IQVIA
• No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

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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.

coverage

• With Glax­o­SmithK­line in the rearview mir­ror, Ab­bas Hus­sain is ready to lead a biotech of his own; Doug Tre­co scores first CEO job since Ra Phar­ma buy­out
• Karyopharm taps long­time Pfiz­er, Am­gen vet to steer the ship; With Mer­ck in the rearview mir­ror, Roger Perl­mut­ter stakes his claim to a CEO job — and it's a sur­pris­ing choice
• The pres­sure builds for Em­ma Walm­s­ley as Glax­o­SmithK­line miss­es Q1 pro­jec­tion, drops more can­cer drugs

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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.

coverage

• John Robin­son re­cruits a small band of Ar­ray vets to kick­start dis­cov­ery at Co­gent; Syn­tim­mune co-founder takes charge at Arch On­col­o­gy
• Sana prices at near record IPO, lead­ing pack of Nas­daq new­com­ers
• The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

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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.

coverage

• Bio­gen pressed against the wall as more stake­hold­ers side against Aduhelm; Prime time for CRISPR 3.0?; and more
• As its next big bet, Sana inks long-term lease for man­u­fac­tur­ing site for next-gen cell ther­a­pies
• Are 'plat­form plays' here to stay?; The Aduhelm saga con­tin­ues to un­fold; A new GSK?; and more

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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.

coverage

• CFO tran­si­tion on the hori­zon at BioN­Tech as Sierk Po­et­ting con­cen­trates on COO du­ties; Centes­sa rides a wave of new ex­ecs af­ter An­toine Yver's ap­point­ment
• Per­cep­tive's Chi­na up­start Lian­Bio con­tin­ues swing­ing deals, team­ing up with lead Xon­toge­ny biotech Lan­dos in IBD
• No­vavax CFO Greg Covi­no makes a quick ex­it as lead­er­ship carousel keeps turn­ing; Kite ex­ecs fly away to a cell ther­a­py up­start team­ing up with Lyell

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The SPAC from Brook­line Cap­i­tal Mar­kets has closed a $57.5 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 29. Its syn­di­cate in­cludes Samuel Wertheimer, a for­mer part­ner at Or­biMed.

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The SPAC from Laden­burg Thal­mann has closed a $57.5 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 28. Its syn­di­cate in­cludes the firm’s co-CEO and chair­man David Rosen­berg.

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The SPAC from Health­Cor Man­age­ment and Catalio Cap­i­tal Man­age­ment has closed a $207 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 27. Its syn­di­cate in­cludes Health­Cor port­fo­lio man­ag­er Christo­pher Gaulin and George Petrochei­los, a co-founder at Catalio.

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The SPAC from CRO and ven­ture in­vestor SPRIM has closed a $230 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 26. Its syn­di­cate in­cludes SPRIM’s man­ag­ing part­ner Michael Shleifer.

coverage

• UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play
• Ed­uar­do Bra­vo re­turns to bring Eu­ro­pean biotech in on the SPAC splurge
• Fore­site re­turns to the SPAC well, as in­vestors won­der how long the run can last

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The SPAC from One Eq­ui­ty Part­ners has closed a $345 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 22. Its syn­di­cate in­cludes the firm’s op­er­at­ing part­ner Todd Bradley.

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The SPAC from SCP & CO has closed a $230 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 22. Its syn­di­cate in­cludes the firm’s man­ag­ing di­rec­tors Scott Feuer and Bryan Crino.

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The SPAC from Hoth Ther­a­peu­tics CEO Robb Knie has closed a $57.5 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 20. Its syn­di­cate in­cludes Knie and Sun­deep Agraw­al.

coverage

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

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The SPAC from in­de­pen­dent life sci­ences and tech in­vestor David Milch has closed a $275 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 15. Its syn­di­cate in­cludes Milch, who has been in­vest­ing for over 30 years, as well as CEO William Johns and CFO Philip Ba­seil.

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The SPAC from for­mer Bis­cayne Neu­rother­a­peu­tics co-founder Samuel Re­ich has closed a $115 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 12. Its syn­di­cate in­cludes Re­ich, who found­ed Bis­cayne in 2011 and lat­er sold it to Su­per­nus in 2018, as well as Jef­frey Spra­gens, who pre­vi­ous­ly co-found­ed SafeStitch Med­ical in 2005 and served as CEO un­til its merg­er with TransEn­ter­ix in 2013.

coverage

• Are 'plat­form plays' here to stay?; The Aduhelm saga con­tin­ues to un­fold; A new GSK?; and more
• The Covid-19 trans­genic cow an­ti­body start­up goes pub­lic in $325M SPAC merg­er
• News brief­ing: Zio­pharm dra­ma con­tin­ues with new let­ter from ac­tivist group; Al­ny­lam, Cen­to­gene join forces on AT­TRv screen­ing pro­gram

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The SPAC from Kennedy Lewis In­vest­ment Man­age­ment has closed a $287.5 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 8. Its syn­di­cate in­cludes Kennedy Lewis part­ner Doug Logi­gian, who pre­vi­ous­ly worked at Black­stone, as well as oth­er Kennedy Lewis part­ners.

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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.

coverage

• Mod­er­na dips in­to J&J's tal­ent pool for Tal Zak­s' re­place­ment; Jim Mullen choos­es next chief sci­en­tist at Ed­i­tas Med­i­cine
• Chris Garabe­di­an's first Xon­toge­ny com­pa­ny, Lan­dos Bio­phar­ma, preps a nine-fig­ure IPO as lead pro­gram heads to PhI­II
• Nas­daq rings in its first biotech IPOs of 2021: a CAR-T spe­cial­ist from Chi­na, a can­cer port­fo­lio play, and a SPAC

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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.

coverage

• As Co­di­ak en­ters 'next phase of growth,' Jen­nifer Whel­er steps in­to CMO role; Mark Tim­ney lines up his sec­ond CEO op­por­tu­ni­ty af­ter Pur­due Phar­ma reign
• Chris Garabe­di­an's first Xon­toge­ny com­pa­ny, Lan­dos Bio­phar­ma, preps a nine-fig­ure IPO as lead pro­gram heads to PhI­II
• Nas­daq rings in its first biotech IPOs of 2021: a CAR-T spe­cial­ist from Chi­na, a can­cer port­fo­lio play, and a SPAC

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The SPAC from Omega Fund Man­age­ment has closed a $120 mil­lion raise for its shell com­pa­ny, pric­ing on Jan. 7. Its syn­di­cate in­cludes Otel­lo Stam­pac­chia, man­ag­ing di­rec­tor at Omega and a ma­jor in­vestor in biotechs like Kro­nos and Spruce.

coverage

• Lega­cies: 60 bio­phar­ma pi­o­neers over 60 who helped birth a tech rev­o­lu­tion in the mak­ing