IPO TRACKER

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What do you get when some of the most pow­er­ful CD­MOs in the world join forces? The first SPAC ded­i­cat­ed to meet­ing the crit­i­cal de­mand for bio­man­u­fac­tur­ing on the con­ti­nent. eu­reK­ING is backed by eu­reKARE, the in­vest­ment com­pa­ny fo­cused on de­vel­op­ing syn­thet­ic bi­ol­o­gy and mi­cro­bio­me in­no­va­tion across Eu­rope. The com­pa­ny has plans to raise 150 mil­lion eu­ros, list on the Eu­ronext Paris and has iden­ti­fied 40 man­u­fac­tur­ing tar­gets. The cre­ation of the SPAC tar­gets a boom­ing, yet frag­ment­ed in­dus­try, eu­reK­ING says on its web­site. It will high­light three high-growth seg­ments: bi­o­log­ics, cell and gene ther­a­py and live bio­ther­a­peu­tics. It will seek to fill a gap left be­hind by small- to mid-sized biotechs that aren’t ad­dressed by the largest CD­MOs, and pro­vide lo­cal fa­cil­i­ties. eu­reK­ING dubs bio­man­u­fac­tur­ing the “next Eu­ro­pean Fron­tier” on its web­site.

coverage

• Pfiz­er's $11.6B wa­ger; TIG­IT im­plo­sion; An un­usu­al phar­ma-biotech pact; In­side a16z's vi­sion to re­shape biotech; and more
• Ex-Sanofi CEO on board, a new $158M SPAC de­buts look­ing to shake up the Eu­ro­pean CD­MO mar­ket

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Sen­ti Bio and its SPAC part­ner, Omid Farokhzad’s Dy­nam­ics Spe­cial Pur­pose Corp., com­plet­ed their merg­er on June 9. Orig­i­nal­ly ex­pect­ed to de­liv­er $296 mil­lion in gross pro­ceeds, the fi­nal deal left Sen­ti with $140.3 mil­lion. Those funds in­clud­ed $84.5 mil­lion of the ex­pect­ed $86 mil­lion from the SPAC trust, $50.6 mil­lion of the ex­pect­ed $66.8 mil­lion from the PIPE fi­nanc­ing, and a re­cent $5.2 mil­lion in­vest­ment by Leaps by Bay­er. How­ev­er, due to one in­vestor, Life­Force Cap­i­tal, fail­ing to time­ly fund its $16.2 mil­lion com­mit­ment, Sen­ti was forced to waive a $150 mil­lion cash clos­ing con­di­tion re­lat­ed to the deal, in or­der to fin­ish the merg­er by June 9. Sen­ti Bio says it in­tends to en­force Life­Force’s le­gal oblig­a­tions un­der its sub­scrip­tion agree­ment.

coverage

• Af­ter ditch­ing elec­tric ve­hi­cle parts mak­er, a SPAC choos­es a Brown spin­out that had test­ed the IPO wa­ters
• No Myth: CEO of ADC up­start calls it quits; Bris­tol My­ers vet Jon Wig­gin­ton scales new heights at Bright Peak
• Hu­man Longevi­ty makes a move to­ward Nas­daq with po­ten­tial SPAC deal, but noth­ing's fi­nal yet

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Eleu­sis had an­nounced its planned SPAC merg­er on Jan­u­ary 20, but said the deal had been ter­mi­nat­ed on June 9. The biotech has been fo­cused on mak­ing psy­che­delics in­to med­i­cines, and its lead can­di­date — a psilo­cy­bin in­fu­sion called ELE-Psi­lo — in de­vel­op­ment for de­pres­sion. ELE-Psi­lo is ex­pect­ed to en­ter Phase I tri­als some­time this year. Psilo­cy­bin is a hal­lu­cino­gen nor­mal­ly found in “mag­ic mush­rooms,” a type of nat­u­ral­ly-grown mush­room that has been used for recre­ation­al and re­li­gious pur­pos­es. Ac­cord­ing to the biotech, an IV in­fu­sion of the hal­lu­cino­gen would be more ef­fec­tive than oral in­ges­tion be­cause it would cut down on vari­abil­i­ty. Ab­sorp­tion and me­tab­o­lism would vary sig­nif­i­cant­ly in dif­fer­ent pa­tients with the same dose of psilo­cy­bin when done oral­ly, which would de­crease when in­ject­ed straight in­to the blood­stream, Eleu­sis said. Eleu­sis had ex­pect­ed to use the pro­ceeds re­ceived from Sil­ver Spike Ac­qui­si­tion Corp. II to sup­port con­tin­ued clin­i­cal de­vel­op­ment of ELE-Psi­lo, move ear­ly stage drug dis­cov­ery and trans­la­tion­al re­search for­ward and fa­cil­i­tate ex­pan­sion of Eleu­sis’s sub­sidiary An­dala, which man­ages psy­chi­atric care clin­ics na­tion­al­ly.

coverage

• In­side the race to make psy­che­delics 'main­stream med­i­ci­nes'
• What lured Hal Bar­ron away?; Top FDA minds on ac­cel­er­at­ed ap­proval re­forms; ‘Dead wrong’ Aduhelm ad blitz; and more
• Psy­che­delics biotech set to go pub­lic via SPAC — push­ing IV form of psilo­cy­bin in­to PhI

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A pre­clin­i­cal play­er, the biotech is work­ing on new treat­ments for in­flam­ma­to­ry dry eye dis­eases and oc­u­lar pain. Its lead pro­gram, OK-101, is in the midst of the IND sub­mis­sion process. Okyo says a Phase I study will not be re­quired, and a Phase II study is ex­pect­ed to be­gin in ei­ther the fourth quar­ter of 2022 or ear­ly 2023. Ex­ecs an­tic­i­pate Phase II da­ta to come in the sec­ond half of 2023.

coverage

• Io­n­is, Cy­cle­ri­on tout pos­i­tive da­ta read­outs; MA­IA prices first biotech IPO in over two months
• Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo
• Lon­don biotech com­pletes $2.5M mi­cro IPO; AGTC touts ear­ly gene ther­a­py da­ta — but in­vestors keep their dis­tance

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Pep­Gen de­buted on Wall Street about a month af­ter tran­si­tion­ing to a clin­i­cal-stage com­pa­ny with its Duchenne mus­cu­lar dy­s­tro­phy tri­al in Cana­da. The biotech fo­cus­es on de­vel­op­ing “cell-pen­e­trat­ing” pep­tides for se­vere neu­ro­mus­cu­lar dis­eases, such as DMD, with lead can­di­date PGN-EDO51 ex­pect­ed to read out topline da­ta by the end of 2022. Pep­Gen priced be­low its range, mark­ing a rough pub­licly trad­ed start for the RA-backed com­pa­ny’s ef­forts to im­prove up­on Sarep­ta’s DMD drug Ex­ondys 51. In the pri­vate mar­kets, Pep­Gen se­cured $113 mil­lion in crossover in­vestor in­ter­est in the sum­mer of 2021. Pep­Gen wants to raise mon­ey for the lead DMD as­set, an IND in the first half of 2023 for a my­oton­ic dy­s­tro­phy type 1 drug and three more DMD ther­a­pies (all tar­get­ing dif­fer­ent ex­ons) fur­ther down in the pipeline.

coverage

• Amid mas­sive turnover, Agios hires Bio­gen alum as new CFO; Schol­ar Rock, Ever­est Med­i­cines lead the big CEO pa­rade
• BeiGene co-founder and ex-Viela Bio BD leader snag $200M for age-re­lat­ed biotech, with ARCH jump­ing in
• Bio­gen's shake­up from the top; How to build a biotech to­day; David Saba­ti­ni backs out of NYU; and more

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Hill­e­Vax is a norovirus vac­cine de­vel­op­er spunout from Take­da by late biotech leg­end Tachi Ya­ma­da. The com­pa­ny made the pub­lic leap less than 10 months af­ter be­ing spun out from Take­da, with back­ing from Fra­zier Health­care Part­ners. Hill­e­Vax launched with a Take­da norovirus vac­cine can­di­date that had al­ready com­plet­ed sev­er­al stud­ies; Hill­e­Vax says it’s now been a part of nine Phase I and Phase II tri­als. The shot is be­ing test­ed in a slate of Phase II stud­ies aim­ing to eval­u­ate its ef­fec­tive­ness in dif­fer­ent age pop­u­la­tions. Hill­e­Vax says in its S-1 it plans to launch a Phase IIb study in in­fants some­time in the sec­ond quar­ter, mark­ing the first study it will con­duct, rather than Take­da. The goal is to en­roll about 200 in­fants. Hill­e­Vax aims to re­port in­ter­im im­muno­genic­i­ty da­ta in the first half of 2023, fol­lowed by top-line da­ta in the sec­ond half. Funds from the IPO are ex­pect­ed to be uti­lized for this study, as well as to prep for an even­tu­al Phase III tri­al.

coverage

• All in on ear­ly-stage, Qim­ing US bags $260M, re­cruits Atara founder Isaac Ciechanover for Fund III
• Bear mar­ket slows Pep­Gen's roll, caus­ing DMD-fo­cused biotech to price be­low range
• Your guide to phar­ma Q1 num­bers; Un­pack­ing top 15 R&D gi­ants; Se­cret PhI­II fail­ures; 'Weirdo sci­ence' and meta­science; and more

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The com­pa­ny is de­vel­op­ing an eye dis­ease pro­gram, dubbed LBS-008, with a Phase III tri­al that launched in the first quar­ter. The com­pa­ny is test­ing it in both dry AMD and Star­gardt dis­ease, with the piv­otal study ex­am­in­ing ado­les­cents who suf­fer from the lat­ter con­di­tion. Its can­di­date is an oral once-a-day treat­ment de­signed to re­duce and main­tain the de­liv­ery of vi­t­a­min A to the eye. The pro­gram is el­i­gi­ble for a pri­or­i­ty re­view vouch­er should it be ap­proved, po­ten­tial­ly an­oth­er source of cash for Be­lite Bio. Most of the IPO funds are slat­ed for fur­ther clin­i­cal de­vel­op­ment of LBS-008 in dry AMD, and Be­lite Bio hopes the of­fer­ing will en­able it to com­plete its on­go­ing Phase II and Phase III clin­i­cal tri­als in both dry AMD and Star­gardt dis­ease.

coverage

• Bear mar­ket slows Pep­Gen's roll, caus­ing DMD-fo­cused biotech to price be­low range
• Your guide to phar­ma Q1 num­bers; Un­pack­ing top 15 R&D gi­ants; Se­cret PhI­II fail­ures; 'Weirdo sci­ence' and meta­science; and more
• De­spite bruis­ing mar­ket, two biotechs price their IPOs while an­oth­er launch­es its Nas­daq bid

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About 14 months af­ter ink­ing a nat­ur­al killer cell deal with Cel­lec­tis, Cy­tovia agreed with the SPAC Isle­worth Health­care Ac­qui­si­tion to hit the Nas­daq in a blank check deal. It will bankroll INDs and the ini­ti­a­tion of Phase I/II clin­i­cal tri­als for four as­sets: CYT-303, CYT-100, CYT-150 and CYT-503. Af­ter dol­ing out $15 mil­lion up­front, with $760 mil­lion in mile­stones an­tic­i­pat­ed, to Cel­lec­tis in Feb­ru­ary 2021, the com­pa­ny went on to cre­ate a Chi­na joint ven­ture. The biotech teamed up with Chi­na-based biotech in­vestor TF Cap­i­tal to form Cy­toL­ynx Ther­a­peu­tics, with $45 mil­lion in fund­ing, in Sep­tem­ber 2021. Aside from its part­ner­ship with Cel­lec­tis, Cy­tovia al­so has linked arms with Cy­toIm­mune Ther­a­peu­tics, the He­brew Uni­ver­si­ty of Jerusalem, IN­SERM, the New York Stem Cell Foun­da­tion, the Na­tion­al Can­cer In­sti­tute, and the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co.

coverage

• Cel­lec­tis signs $760M mile­stone deal with NK up­start; Im­muno­core brings on As­traZeneca vet to shep­herd bis­pe­cif­ic launch plans
• In­ovio adds two to the lead­er­ship team; Adri­an Woolf­son is out at Sang­amo

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Co­ep­tis’ merg­er agree­ment with Bull Horn Hold­ings Corp. came just six days af­ter the biotech an­nounced it planned to ac­quire Stat­era’s TLR5 ag­o­nist plat­form, in­clud­ing en­tolimod, for $6 mil­lion up­front and undis­closed biobucks to fol­low. In De­cem­ber 2021, the FDA lift­ed its clin­i­cal hold on en­tolimod for the treat­ment of acute ra­di­a­tion syn­drome. The po­ten­tial lethal ra­di­a­tion stock­pile drug will like­ly en­ter a Phase II by the end of 2022, CEO Dave Mehal­ick told End­points. Co­ep­tis is al­so work­ing on de­vel­op­ing a cell ther­a­py tar­get­ing CD38-re­lat­ed can­cers and a pre-clin­i­cal in vit­ro di­ag­nos­tic for such can­cers with part­ner Vy­Gen-Bio. The ther­a­peu­tic is in­tend­ed to en­able com­bo ther­a­py with an­ti-CD38 mon­o­clon­al an­ti­bod­ies. The CEO found­ed Co­ep­tis in 2017 with for­mer em­ploy­ees from Three Rivers Phar­ma­ceu­ti­cals, which was bought by Kad­mon in 2010. Sanofi ac­quired Kad­mon for about $1.9 bil­lion last Sep­tem­ber.

coverage

• End­points 20 un­der 40; Ver­dict on PI3K; Re­gen­eron goes dis­count shop­ping; $1.85B deal im­plodes; and more
• 'Tim­ing could­n't be bet­ter': An ex-gener­ics mak­er goes SPAC route with blank check in­tend­ed for sports mar­ket

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Ac­celus and SPAC part­ner CHP Merg­er Corp. called off their busi­ness com­bi­na­tion due to “mar­ket con­di­tions.” The pair had an­nounced in No­vem­ber 2021 that it would at­tempt to take Ac­celus, which fo­cus­es on mak­ing min­i­mal­ly in­va­sive surgery (MIS) a stan­dard of care in spine treat­ment, pub­lic through the $482 mil­lion blank check ve­hi­cle. When the merg­er was first an­nounced, Ac­celus CEO and co-founder Chris Walsh was slat­ed to helm the new com­pa­ny af­ter more than two decades in the space. Out­side of Ac­celus, Walsh spent more than a decade at San Diego de­vice mak­er Nu­Va­sive and about sev­en years in the spine team at Stryk­er, a Michi­gan med­ical tech­nol­o­gy com­pa­ny.

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Jim Tanan­baum’s Fore­site Cap­i­tal with­drew its third SPAC pitch in April, hav­ing aimed to raise $250 mil­lion. Fore­site did not give a rea­son in its with­draw­al re­quest. Tanan­baum’s firm ini­tial­ly filed the S-1 in late Feb­ru­ary 2021, around the time when IPO and SPAC ac­tiv­i­ty were at their high­est. The fil­ing came a cou­ple weeks be­fore the SEC asked that the in­sti­tu­tions ad­vis­ing SPACs, such as big banks, vol­un­tar­i­ly pro­vide reg­u­la­tors with their in­ter­nal polic­ing strate­gies. It al­so wasn’t Tanan­baum’s first for­ay in­to the blank check mar­ket ei­ther, as Fore­site had pre­vi­ous­ly tak­en two com­pa­nies pub­lic through re­verse merg­ers. Gem­i­ni Ther­a­peu­tics went pub­lic with a $216 mil­lion SPAC in Oc­to­ber 2020, while Pardes Bio­sciences leapt to Nas­daq with $199 mil­lion in tow af­ter an­nounc­ing in June 2021.

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AN2 falls un­der RA Cap­i­tal Man­age­ment’s port­fo­lio of new­ly pub­lic com­pa­nies. The biotech re­ceived big back­ing from the Pe­ter Kolchin­sky/Raj Shah-run VC firm in an $80 mil­lion Se­ries A in Jan­u­ary. They fol­lowed it up with the IPO in March. The new mon­ey, ac­cord­ing to AN2, will go to fund fur­ther clin­i­cal de­vel­op­ment of lead — and so far, sole — can­di­date epe­tra­bo­role in an on­go­ing Phase I tri­al, a planned Phase II/III piv­otal tri­al, man­u­fac­tur­ing and ex­pand­ing in­to oth­er in­di­ca­tions with­in lung dis­ease and in­fec­tions. AN2’s pub­lic turn comes af­ter a large­ly qui­et pe­ri­od since its launch in 2019, when it of­fered on­ly two press re­leas­es in three years — its Se­ries A and Se­ries B an­nounce­ments.

coverage

• Hel­lo, I must be go­ing: Jorge Gomez is Mod­er­na CFO for on­ly a day; As set­backs mount, In­ovio’s Joseph Kim choos­es the ex­it ramp
• ALS drug sets the stage for fresh FDA de­bate; Im­plo­sions every­where you look; Big names turn up at biotechs; and more
• An­oth­er RA-backed biotech hits Nas­daq as pub­lic mar­ket stirs again af­ter a bruis­ing first quar­ter

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Par­ent com­pa­ny Lig­and Phar­ma­ceu­ti­cals had an­nounced it would spin out its an­ti­body dis­cov­ery unit in No­vem­ber 2021, but didn’t de­cide un­til March 2022 to take the SPAC route. Om­niAb is part­ner­ing with Avista Pub­lic Ac­qui­si­tion Corp. II in a deal ex­pect­ed to de­liv­er at least $130 mil­lion and at most $266 mil­lion in cash, de­pend­ing on whether APAC share­hold­ers de­cide to cash out. Avista has al­so promised to in­vest an ad­di­tion­al $115 mil­lion ($15 mil­lion as a PIPE, and the rest to back­stop po­ten­tial re­demp­tions), while Lig­and will con­tribute $15 mil­lion. An­ti­bod­ies gen­er­at­ed from the Om­niAb plat­form — which spans a num­ber of trans­genic an­i­mals from rat to chick­en to mouse — could rack up 10 ap­provals by 2028, per Lig­and pro­jec­tions. The first ones came in 2021, when Glo­ri­aBio’s zim­bere­limab and EQRx/CStone’s sug­e­mal­imab were ap­proved in Chi­na for dif­fer­ent types of can­cer. Both an­ti-PD-1 an­ti­bod­ies orig­i­nat­ed on the trans­genic rat plat­form, Om­ni­Rat.

coverage

• Man­u­fac­tur­ing roundup: Lon­za fin­ish­es ex­pand­ing Visp site; CBM to pro­duce jCyte’s cell ther­a­py
• A Penn spin­out goes dark; Thumbs down on ALS drug; TIG­IT runs in­to PhI­II flop; Sanofi's got big plans; and more
• On­tario antes up $580M for C&G ther­a­py plant in Hamil­ton

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Sor­ren­to first bought a ma­jor­i­ty stake in Scilex and its patch de­liv­ery tech for non-opi­oid ther­a­pies back in 2016, and has de­cid­ed to spin it out in a SPAC deal with Vick­ers Van­tage Corp I. The com­pa­ny’s lead prod­uct, a top­i­cal for­mu­la­tion of li­do­caine called ZTli­do, is ap­proved to treat post-her­pet­ic neu­ral­gia, a form of post-shin­gles nerve pain. The deal will help fund a sec­ond prod­uct, SP-102, which Scilex aims to com­mer­cial­ize for lum­bar radic­u­lar pain or sci­at­i­ca in 2023, plus a cou­ple of oth­er pro­grams. Scilex al­so has re­vealed Phase III da­ta it tout­ed as pos­i­tive for SP-102, eval­u­at­ing it in pa­tients with low­er back pain. The pro­gram met its pri­ma­ry end­point, re­duc­ing the av­er­age dai­ly pain in the af­fect­ed leg over 4 weeks fol­low­ing the ini­tial in­jec­tion at a sta­tis­ti­cal­ly sig­nif­i­cant rate.

coverage

• Watch out En­do: Sor­ren­to is af­ter your $1B+ drug with FDA OK of ZTli­do

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Rough­ly a month af­ter Am­i­cus Ther­a­peu­tics re­port­ed an un­ex­pect­ed set­back in a gene ther­a­py planned to be spun out in a SPAC deal, the biotech and its blank check part­ner called off the merg­er in Feb­ru­ary. Am­i­cus will not spin out its gene ther­a­py unit with Arya Sci­ences Ac­qui­si­tion IV, the fourth SPAC be­long­ing to Joseph Edel­man’s Per­cep­tive, af­ter all. The two say they mu­tu­al­ly agreed to end merg­er dis­cus­sions, leav­ing Edel­man with about an­oth­er year to find a part­ner to take pub­lic. Am­i­cus CEO John Crow­ley said the de­ci­sion re­sult­ed from “cur­rent un­fa­vor­able mar­ket con­di­tions” re­lat­ed to biotech IPOs, SPACs and fol­low-on fi­nanc­ings. He al­so de­scribed an “in­creas­ing­ly chal­leng­ing” en­vi­ron­ment for stand­alone gene ther­a­py com­pa­nies — both on Nas­daq and at the FDA. The pro­posed spin-out last Sep­tem­ber had aimed to bring Am­i­cus’ Bat­ten dis­ease pro­grams to mar­ket in its own pub­lic com­pa­ny. Planned to be called Car­i­tas Ther­a­peu­tics, the com­pa­ny was sup­posed to start with two clin­i­cal can­di­dates in the dis­ease, both of which Am­i­cus said had at­tained proof-of-con­cept.

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Blue Wa­ter does not have any pro­grams in the clin­ic just yet. It’s de­vel­op­ing sev­er­al dif­fer­ent vac­cine can­di­dates rang­ing from a uni­ver­sal flu shot to a stand­alone, long-last­ing H1 flu shot. The com­pa­ny is al­so re­search­ing a norovirus/ro­tavirus vac­cine, a norovirus/malar­ia vac­cine and a Strep­to­coc­cus pneu­mo­ni­ae vac­cine. The biotech is us­ing the mon­ey pri­mar­i­ly to ad­vance a slate of pre­clin­i­cal pro­grams to­ward IND stud­ies and boost man­u­fac­tur­ing ca­pa­bil­i­ties. In ad­di­tion, some of the cash will al­so be used to fund Phase I stud­ies for the flu shots and the Strep­to­coc­cus pneu­mo­ni­ae vac­cine.

coverage

• Mod­er­na goes on the patent of­fen­sive; Pablo Legor­re­ta dou­bles down; Is a biotech re­cov­ery on the way?; and more
• 'Noth­ing es­capes our sci­en­tist­s': A hand­ful of biotechs gear up work on mon­key­pox
• A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

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Way back in 2017, TC Bio­pharm teamed up with blue­bird bio on an ex­per­i­men­tal pro­gram in­volv­ing CAR-en­gi­neered gam­ma delta T cells, and that’s where they’ve fo­cused the ma­jor­i­ty of their ef­forts. The com­pa­ny is plan­ning on us­ing the IPO fund­ing on a Phase II/III tri­al for the treat­ment of acute myeloid leukemia, as well as a Phase I tri­al for vi­ral in­fec­tions such as Covid-19 and se­vere flu.

coverage

• Till­man Gern­gross leads a pack of biotech CEOs out the door; With eyes on pipeline ex­pan­sion, Po­sei­da woos a gene ther­a­py ex­ec from No­var­tis
• With Mav­er­ick now in Takeda's hands, James Sci­bet­ta turns the page; Roivant CMO leaves in fa­vor of small IL-2 biotech
• Im­Check adds $7.1M to Se­ries B, boost­ing de­vel­op­ment of gam­ma delta T cell pro­grams

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Though Ar­cel­lx priced its IPO at the low end of its range, it had some­thing many oth­er re­cent­ly pub­lic biotechs don’t: da­ta on how its ther­a­pies per­form in hu­mans. In 2020, the com­pa­ny showed its lead BC­MA-tar­get­ing CAR-T for mul­ti­ple myelo­ma shrunk tu­mors in six out of six pa­tients, with four of them ex­pe­ri­enc­ing what’s known as strin­gent com­plete re­sponse. And at #AS­CO22, ex­pand­ed re­sults showed that of 16 pa­tients with 12-month da­ta, 13 achieved a com­plete re­sponse to Ar­cel­lx’s ther­a­py — a CR rate of 81%. While Ar­cel­lx’s BC­MA-tar­get­ed CAR-T ther­a­py would be com­ing be­hind al­ready ap­proved ones from Janssen and Bris­tol My­ers Squibb, Ar­cel­lx CMO Chris Heery is not too con­cerned about the com­pe­ti­tion. He added that Ar­cel­lx will be­gin dos­ing pa­tients in its Phase II tri­al for its BC­MA-tar­get­ed CAR-T ther­a­py lat­er this year.

coverage

• Four years in the mak­ing, Ab­b­Vie and Cal­i­br pro­vide first look in­to ‘switch­able’ CAR-T pro­gram
• Af­ter sev­en months of search­ing, Lan­dos hires a CEO; Mar­ty Du­vall re-emerges from ill-fat­ed On­copep­tides tenure
• #AS­CO22: A small Chi­na biotech play­er makes its de­but at AS­CO with promis­ing da­ta on its GPRC5D mul­ti­ple myelo­ma drug

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Found­ed in 2020, Nu­vec­tis Phar­ma is work­ing on push­ing two in-li­censed can­cer pro­grams in­to the clin­ic, with a lead pro­gram that’s ready for Phase I. That can­di­date, brought in from Lon­don’s In­sti­tute for Can­cer Re­search, is an in­hibitor of the heat shock fac­tor 1 path­way. The biotech’s sec­ond pro­gram comes from the Uni­ver­si­ty of Ed­in­burgh in Scot­land, with a deal signed in Au­gust 2021. It’s a can­di­date try­ing to in­hib­it the SRC and YES 1 ki­nas­es. Nu­vec­tis was found­ed by a pair of ex­ec­u­tives from Stem­line Ther­a­peu­tics and a third biotech vet­er­an, Ron Bentsur, who used to be the CEO of Uro­Gen. Bentsur owns the biggest stake in the com­pa­ny at about 26%.

coverage

• Or­biMed's TKI play makes its Nas­daq de­but as The­seus prices IPO

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Ak­ili In­ter­ac­tive, mak­ers of the first FDA-ap­proved video game, rode its suc­cess­es to a SPAC deal in Jan­u­ary 2022 valu­ing the com­pa­ny at more than $1 bil­lion. But in fil­ing some of its first fi­nan­cial dis­clo­sures, Ak­ili re­vealed it has a tough road ahead to com­mer­cial prof­its. In an S-4 filed with the SEC, the com­pa­ny said it made on­ly about $377,000 in the first nine months of 2021 and in­curred more than $41.6 mil­lion in ex­pens­es over the same time pe­ri­od. The steep op­er­at­ing loss­es came af­ter Ak­ili was more than $25 mil­lion in the red for all of 2020 and lost $21.5 mil­lion in 2019. Those loss­es have raised “sub­stan­tial doubt about the Com­pa­ny’s abil­i­ty to con­tin­ue as a go­ing con­cern,” Ak­ili wrote: It does not have enough cash on hand to con­tin­ue op­er­at­ing for the next year. The deal is ex­pect­ed to fi­nal­ize in mid-2022, with SPAC king and tech bil­lion­aire Chamath Pal­i­hapi­tiya set to be­come chair­man of the board.

coverage

• Pre­view­ing bio­phar­ma trends ahead of #BIO22; Look­ing back at #AS­CO22; Smooth flight for blue­bird?; and more
• Amarin fish­es for an­oth­er CFO as down­siz­ing takes hold; Cure­Vac makes a deal, then lines up No­var­tis ex­ec to lead de­vel­op­ment
• Ak­ili taps new com­mer­cial chief in ad­vance of fall mar­ket­ing launch for AD­HD video game ther­a­py

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The out­spo­ken “Piped Piper of SPACs,” Chamath Pal­i­hapi­tiya, an­nounced he’d be tak­ing ProKid­ney pub­lic in Jan­u­ary 2022. A for­mer Face­book ex­ec­u­tive and co-own­er of the NBA’s Gold­en State War­riors, Pal­i­hapi­tiya launched four SPACs all tar­get­ing dif­fer­ent sec­tors of biotech in the ear­ly sum­mer of 2021. Pal­i­hapi­tiya has been a promi­nent and in­flu­en­tial fig­ure in this realm, hav­ing pre­vi­ous­ly launched a slate of six SPACs span­ning mul­ti­ple in­dus­tries. ProKid­ney was found­ed in 2016 but re­al­ly got go­ing at the be­gin­ning of 2019 with the $62 mil­lion ac­qui­si­tion of in­Re­gen, which was work­ing on an au­tol­o­gous — from the pa­tient — cell ther­a­py for kid­ney dis­ease. Af­ter ex­tract­ing kid­ney cells from pa­tients, re­searchers ex­pand the cells in the lab and then in­ject them back in­to pa­tients, aim­ing to re­store the kid­neys of pa­tients suf­fer­ing from CKD. Four of Pal­i­hapi­tiya’s 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.

coverage

• Jay Brad­ner’s NI­BR ex­it sets off a suc­ces­sion plan at Mer­ck; Dyne and Mor­phoSys fill ma­jor R&D roles
• As Covid pro­gram ad­vances, Enan­ta's new CMO says it's not 'lim­it­ed to an­tivi­ral­s'; With all eyes on Gilead-part­nered can­cer drugs, Ar­cus brings med­ical chief on board
• Re­veal­ing heavy loss­es in new SEC fil­ing, video game ther­a­peu­tic mak­er Ak­ili de­tails an un­cer­tain fi­nan­cial fu­ture

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De­vel­op­ing weight-man­age­ment pills that are on the cusp of a na­tion­al roll­out, PureTech-found­ed Gele­sis an­nounced it would re­verse-merge with Cap­star Spe­cial Pur­pose Ac­qui­si­tion Corp. in Ju­ly 2021. The deal was pro­ject­ed to give Gele­sis ac­cess to the $376 mil­lion raised from the SPAC, as well as an­oth­er $100 mil­lion in PIPE fund­ing, but af­ter 98% of SPAC in­vestors pulled out, the com­pa­ny end­ed up with on­ly $105 mil­lion in gross pro­ceeds. With the sub­stan­tial de­crease in funds, Gele­sis was forced to lay off 140 con­trac­tors in Feb­ru­ary that had been hired to pro­mote its weight-loss pill Plen­i­ty. Tak­en twice a day be­fore lunch and din­ner, the $98-per-month treat­ment is de­signed to ex­pand in the stom­ach, mak­ing adults feel fuller with small­er por­tions of food. It was ap­proved in 2019. Gele­sis is the third PureTech en­ti­ty to go pub­lic af­ter Karuna Ther­a­peu­tics hit Nas­daq with a tra­di­tion­al IPO in 2019 and Vor Bio­phar­ma fol­lowed suit in ear­ly 2021.

coverage

• Bio­gen's shake­up from the top; How to build a biotech to­day; David Saba­ti­ni backs out of NYU; and more
• Re­veal­ing heavy loss­es in new SEC fil­ing, video game ther­a­peu­tic mak­er Ak­ili de­tails an un­cer­tain fi­nan­cial fu­ture
• R&D heads play phar­ma mu­si­cal chairs; Shat­tered block­buster dreams; Death of Aduhelm?; and more

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Hill­stream has been fo­cused on fer­rop­to­sis, a type of pro­grammed cell death be­ing stud­ied for treat­ment re­sis­tant can­cers. The com­pa­ny’s most ad­vanced can­di­date is HSB-1216, an iron me­di­at­ed cell death (IM­CD) in­duc­er for sol­id tu­mors. Hill­stream aims to sub­mit an IND and start a clin­i­cal study with the drug next year.

coverage

• French biotech and Pfiz­er find pos­i­tives in da­ta for Ly­me dis­ease vac­cine can­di­date; Al­tim­mune's obe­si­ty drug shows promise in PhI tri­al

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Cin­Cor Phar­ma made some noise af­ter rais­ing $143 mil­lion in a Se­ries B in Oc­to­ber 2021, and a few weeks lat­er planned a jump to Nas­daq. For­mer Ipsen chair­man and CEO Marc de Garidel had big plans with the de­but, spin­ning out from par­ent com­pa­ny Cin­Rx Phar­ma. The com­pa­ny is go­ing all in on Cin­Cor’s on­ly drug can­di­date: bax­dro­stat, or CIN-107, an oral al­dos­terone syn­thase in­hibitor that co-founders Jon Isaac­sohn and Cather­ine Pearce li­censed from Roche for $3 mil­lion back in 2019. Al­dos­terone is a hor­mone linked to in­creased blood pres­sure, and has been a tar­get of in­ter­est to treat hy­per­ten­sion. Once bax­dro­stat reach­es cer­tain mile­stones, Cin­Cor will pay Roche an­oth­er $40 mil­lion, along with an ad­di­tion­al $175 mil­lion in sales mile­stones, plus roy­al­ties. Phase II da­ta are ex­pect­ed in the lead in­di­ca­tion of treat­ment-re­sis­tant hy­per­ten­sion in the sec­ond half of 2022. It’s al­so be­ing stud­ied in un­con­trolled hy­per­ten­sion (Phase II topline ex­pect­ed 2H 2023), pri­ma­ry al­dos­tero­nism (Phase II topline ex­pect­ed 2H 2023) and pa­tients with both un­con­trolled hy­per­ten­sion and chron­ic kid­ney dis­ease (Phase II topline ex­pect­ed 2H 2023).

coverage

• #ESC22: Cin­Cor CMO’s 17-year jour­ney in bring­ing a new hy­per­ten­sion drug to mar­ket con­tin­ues
• Biotech's 'sug­ar high' led to a cor­rec­tion, but win­ter dol­drums could make way for a turn­around sto­ry this fall
• Fol­low­ing the re­cent play­book, Cin­Cor rais­es $225M on back of pos­i­tive PhII read­out

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Amy­lyx has the en­tire ALS pa­tient com­mu­ni­ty be­hind its back, as its lead pro­gram is cur­rent­ly sit­ting be­fore the FDA to po­ten­tial­ly be­come just the third-ever ap­proved treat­ment for the uni­ver­sal­ly fa­tal dis­ease. The biotech went pub­lic back in Jan­u­ary be­fore get­ting a date with the FDA ad­vi­so­ry com­mit­tee in late March. Agency pan­elists rec­om­mend­ed against rec­om­mend­ing ap­proval in a slim 6-4 vote that fea­tured a near­ly two-hour long pub­lic com­ment pe­ri­od. Ob­servers are close­ly watch­ing the Amy­lyx ALS drug, dubbed AMX0035, in the wake of the Bio­gen Aduhelm fi­as­co, key­ing in on the pres­sure reg­u­la­tors are fac­ing to ap­prove the com­pound. The cen­tral is­sue of the ad­comm had to do with whether the Amy­lyx drug should be ap­proved on the ba­sis of a sin­gle ran­dom­ized tri­al, or if it should wait for Phase III da­ta to read out, like­ly in 2024. Amy­lyx re­ceived a PDU­FA de­lay on its ap­pli­ca­tion, push­ing the de­ci­sion back to Sep­tem­ber 29.

coverage

• Lat­est news on FDA’s sec­ond look at Amy­lyx; Un­pack­ing Parkin­son’s R&D; Fiona Mar­shall takes over NI­BR from Jay Brad­ner; and more
• FDA again finds Amy­lyx's ALS da­ta lack­ing ahead of un­usu­al sec­ond ad­comm, while stress­ing dire need for treat­ments
• Mod­er­na goes on the patent of­fen­sive; Pablo Legor­re­ta dou­bles down; Is a biotech re­cov­ery on the way?; and more

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Vig­il launched back in De­cem­ber 2020 with $50 mil­lion in Se­ries A cash and a cou­ple of TREM2 ag­o­nists picked up from Am­gen af­ter it joined Big Phar­ma’s mass ex­o­dus from neu­ro­science. Then in Au­gust 2021, the biotech reeled in an­oth­er $90 mil­lion from VC in­vestors. Now the lead can­di­date, VGL101, is in a Phase I study for an in­her­it­ed con­di­tion called adult-on­set leukoen­cephalopa­thy with ax­on­al spher­oids and pig­ment­ed glia (AL­SP), which is char­ac­ter­ized by changes to cer­tain ar­eas of the brain. Pa­tients with AL­SP of­ten ex­pe­ri­ence ear­ly symp­toms like per­son­al­i­ty changes or de­pres­sion, and go on to de­vel­op de­men­tia, dif­fi­cul­ty walk­ing and tremor, among oth­er symp­toms. Phase I da­ta are ex­pect­ed in the sec­ond half of 2022, and Vig­il an­tic­i­pates launch­ing a Phase II tri­al in this time­frame as well. An­oth­er TREM2 can­di­date is ex­pect­ed to reach the IND fil­ing stage for ge­net­i­cal­ly de­fined Alzheimer’s sub­pop­u­la­tions.

coverage

• Just like start­ing over: Mod­er­na tees up an­oth­er CFO; Ge­of­frey Porges puts down his SVB pen to join Schrödinger
• For­mer eGe­n­e­sis CEO joins vTv as it tries to make a come­back; Ei­sai nabs Alzheimer’s com­mer­cial ex­ec amid lecanemab push
• Scoop: Af­ter fail­ing to se­cure more funds, a pri­vate gene ther­a­py de­vel­op­er lays off staff