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Last week was a busy one for biotech IPOs, with five more com­pa­nies fil­ing to go pub­lic just be­fore the start of the week­end, in­clud­ing a com­pa­ny led by Glax­o­SmithK­line vet Paul Pe­ter Tak that’s been work­ing on on­colyt­ic virus­es for decades, and a qui­et San Diego-based up­start that’s jump­ing in­to the spot­light with 11 pro­grams com­ing down the pipeline. Each of them pen­ciled in a $100 mil­lion dol­lar raise — but if trends con­tin­ue, they could go on to raise much, much more.

Here’s what you need to know about the lat­est slate of biotechs vy­ing for a spot on Wall Street.

Glax­o­SmithK­line vet Paul Pe­ter Tak takes low-pro­file on­colyt­ic virus play­er to Nas­daq

Paul Pe­ter Tak

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.

Tak — who has made the con­fer­ence rounds and re­cruit­ed a star-stud­ded group of re­search ad­vi­sors since tak­ing the helm six months ago — has filed the pa­per­work to take the biotech pub­lic.

Like many of its peers, Can­del says it’s shoot­ing for a $100 mil­lion raise. But we all know it’s just the stan­dard place­hold­er fig­ure these days that doesn’t have to mean any­thing.

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.

Founder and CSO Es­tu­ar­do Aguilar-Cor­do­va has boast­ed of a “com­pre­hen­sive and promis­ing” clin­i­cal da­ta set in the past — which Tak said is al­so a big draw as he de­cid­ed to leave his pre­vi­ous job at Flag­ship’s Kin­tai.

Es­tu­ar­do Aguilar-Cor­do­va

An­oth­er pull, as the S-1 re­vealed, might be the $2.3 mil­lion non-eq­ui­ty in­cen­tive plan com­pen­sa­tion he re­ceived, boost­ing his pay pack­age to $2.5 mil­lion. CFO John Canepa was al­so wooed with over $1 mil­lion to jump from Fre­quen­cy.

“I don’t know many com­pa­nies that are al­ready Phase II and Phase III but in im­munother­a­py in can­cer that has dosed more than 700 pa­tients that ba­si­cal­ly come more or less out of stealth mode,” he pre­vi­ous­ly told End­points News.

Can­del’s lead can­di­date, CAN-2409, is an ade­n­ovirus-based prod­uct de­signed to be com­bined with the pro­drug vala­cy­clovir. A Phase III in pa­tients with new­ly di­ag­nosed lo­cal­ized prostate can­cer is un­der­way; the com­pa­ny ex­pects to com­plete en­roll­ment in the next three months and read out da­ta in 2024. The same on­colyt­ic virus-pro­drug com­bo will be test­ed for new­ly di­ag­nosed high-grade glioma with­in the next year.

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.

PBM Cap­i­tal is the largest share­hold­er at 26.58%, but Aguilar-Cor­do­va and chief med­ical of­fi­cer Lau­ra Aguilar al­so kept a large chunk to them­selves, each hold­ing about 16%. Oth­er share­hold­ers in­clude North­pond Ven­tures and Tak him­self. — Am­ber Tong 

Here are the tar­gets Bris­tol My­ers Squibb, Roche tapped Vi­vid­ion to work on

Vi­vid­ion made it pret­ty ob­vi­ous that an IPO was in the works.

Jef­frey Hat­field

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 in­clud­ing Lo­gos Cap­i­tal, Box­er Cap­i­tal, Soft­Bank, Avoro, Black­Rock, Ver­sant, RA Cap­i­tal Man­age­ment, T. Rowe Price As­so­ci­ates, Cas­din Cap­i­tal, and so on. All root­ing for the ap­proach they’re tak­ing in can­cer and im­mune dis­or­der drug dis­cov­ery.

And the stat­ed ask — wait for it — is $100 mil­lion.

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.”

The first tar­get, as it turned out, is STAT3. De­scribed as “a down­stream sig­nal trans­duc­er from a di­verse set of cy­tokine and growth fac­tor re­cep­tors,” the tran­scrip­tion fac­tor has been no­to­ri­ous­ly dif­fi­cult to drug.

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. The two com­pa­nies are look­ing at both on­col­o­gy and im­munol­o­gy ap­pli­ca­tions.

As for Roche, Vi­vid­ion not­ed they are de­vel­op­ing a slate of WRN in­hibitors — hit­ting a pro­tein that’s in­volved in DNA dam­age sens­ing and re­pair, al­so known as the Wern­er he­li­case.

Diego Mi­ralles

Most of the new cash, though, will like­ly go to­ward the in-house work, fea­tur­ing a fo­cus on the KEAP1-NRF2 ax­is, with work un­der­way on NRF2 mu­tant and ad­dict­ed can­cers. So far, the com­pa­ny has burned through $74.1 mil­lion.

ARCH, Ver­sant and CHP stand to gain the most from the Nas­daq run, with 16%, 13.5% and 12.3% of the shares re­spec­tive­ly, while Nex­tech holds 5.7%. No­tably, Diego Mi­ralles — for­mer CEO of three cru­cial years who’s since moved to Flag­ship and set­tled in­to a new chief ex­ec­u­tive job — is al­so list­ed for a 2.7% hold­ing (where­as Hat­field’s was not dis­closed). — Am­ber Tong 

Eras­ca breaks the si­lence with 11 pro­grams and big plans to go pub­lic 

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.

Jonathan Lim

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.

Lim pen­ciled in a $100 mil­lion raise — though, in the last year or so, many com­pa­nies have gone on to raise much more. Last Au­gust, Eras­ca land­ed a $36 mil­lion ex­ten­sion on a $200 mil­lion Se­ries B round, bring­ing its to­tal raise to $300 mil­lion.

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.

Eras­ca says it has 11 pro­grams in the works, in­clud­ing two pre­clin­i­cal can­di­dates and sev­en oth­er dis­cov­ery-stage pro­grams. 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.

Back in Jan­u­ary, the com­pa­ny named Nek­tar Ther­a­peu­tics vet Wei Lin as CMO. The Har­vard grad pre­vi­ous­ly worked at Roche/Genen­tech, where his team achieved three US and EU ap­provals for Tecen­triq.

“We have as­sem­bled what we be­lieve to be the deep­est, whol­ly-owned or con­trolled RAS/MAPK path­way-fo­cused pipeline in the in­dus­try,” the com­pa­ny said in its S-1. — Nicole De­Feud­is 

Ima­go looks to fol­low pos­i­tive PhII re­sults all the way to Wall Street

Back in No­vem­ber, Ima­go Bio­Sciences pulled in an $80 mil­lion crossover round that CEO Hugh Rien­hoff said would lead to a pub­lic de­but some­time this year. On Fri­day, the S-1 pa­pers land­ed in the SEC’s hands.

Hugh Rien­hoff

Ima­go pen­ciled in a $100 mil­lion raise 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 re­cent­ly read out pos­i­tive Phase II re­sults 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. Out of 34 pa­tients eval­u­at­ed for mu­tant al­lele fre­quen­cies, the num­ber de­creased in 15 and re­mained the same in 16, with no new mu­ta­tions in the 660 days that fol­lowed.

“The study is now ful­ly en­rolled, so we look for­ward to shar­ing our cu­mu­la­tive da­ta as we con­tin­ue to ad­vance this in­ves­ti­ga­tion­al pro­gram for pa­tients who have few ther­a­peu­tic al­ter­na­tives,” CMO Wan-Jen Hong said of the MF study ear­li­er this month.

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. — Nicole De­Feud­is 

Dy­nacure eyes pub­lic de­but with Io­n­is-de­vel­oped drug 

Just over a year af­ter com­plet­ing a mod­est $55 mil­lion Se­ries C round, French biotech Dy­nacure is look­ing for its own stock tick­er.

The com­pa­ny pen­ciled in a $100 mil­lion raise, ac­cord­ing to its F-1.

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.

Peo­ple with CNM be­gin ex­pe­ri­enc­ing mus­cle weak­ness at any time from birth to ear­ly adult­hood, and many die with­in the first 18 months of life, ac­cord­ing to Dy­nacure. Pa­tients who sur­vive longer need in­tense man­age­ment, in­clud­ing per­ma­nent ven­ti­la­tion, or feed­ing tubes.

Stéphane van Rooi­jen

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.

“Our an­i­mal da­ta sug­gests that Dyn101 may be able to halt dis­ease pro­gres­sion or po­ten­tial­ly re­verse it,” CEO Stéphane van Rooi­jen told End­points News in 2018.

Dy­nacure’s plan­ning an in­ter­im phar­ma­co­ki­net­ic and safe­ty read­out in the sec­ond half of 2022, with fi­nal da­ta slat­ed for 2023. — Nicole De­Feud­is 

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.