5 cash-hun­gry biotechs crowd in­to Nas­daq in search of a $600M-plus wind­fall

The queue to get in­to Nas­daq just got a lot longer.

On Fri­day af­ter the mar­kets closed 5 more biotech’s tossed their S-1s in­to the mix, mark­ing at least 22 IPO pitch­es for the year to date. That falls in line next to the 20 biotechs that had gone pub­lic by this time last year — which marked an­oth­er busy year for pub­lic mar­ket de­buts and the cash they spin for R&D work.

We broke it out on a case-by-case ba­sis:

Der­ma­vant

Vivek Ra­maswamy Roivant

Vivek Ra­maswamy is a crea­ture of habit. He cre­ates drug de­vel­op­ers un­der his um­brel­la com­pa­ny Roivant, beefs up their pipelines with drugs aban­doned or gath­er­ing dust on Big Phar­ma shelves, hires an ex­pe­ri­enced leader to run the shop, and then steers the firm to an IPO. Af­ter tak­ing Ax­o­vant and My­ovant pub­lic — in a pair of IPOs that raised more than half a bil­lion dol­lars — Der­ma­vant is be­ing groomed for a pub­lic de­but. Af­ter buy­ing tap­inarof from GSK $GSK, the biotech is gun­ning for a $100 mil­lion IPO, un­der the sym­bol $DRMT, ac­cord­ing to a fil­ing post­ed on Fri­day.

Bridge­Bio

Neil Ku­mar End­points

Af­ter rais­ing about $299 mil­lion in Jan­u­ary, start­up mill Bridge­Bio is prim­ing it­self for a $225 mil­lion IPO. The Pa­lo Al­to, Cal­i­for­nia-based com­pa­ny has birthed a pletho­ra of star­tups such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, to fo­cus on ge­net­ic dis­eases, en­com­pass­ing der­ma­tol­ogy, on­col­o­gy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy. Run by Neil Ku­mar, Bridge­Bio now has 16 pro­grams, of which 4 are in or ap­proach­ing late-stage de­vel­op­ment. KKR owns a 10% stake in Bridge­Bio, which plans to list un­der the sym­bol $BBIO, ac­cord­ing to a fil­ing post­ed on Fri­day.

Atre­ca

Bank­ing in a be­he­moth $125 mil­lion last Sep­tem­ber — in its third round of fi­nanc­ing — the pre­clin­i­cal biotech Atre­ca is aim­ing for a $100 mil­lion pub­lic de­but. Run by John Or­win — who was in charge of Re­lyp­sa un­til its $1.5 bil­lion takeover — the com­pa­ny is fo­cused on im­munother­a­pies, by us­ing tis­sue sam­ples from can­cer pa­tients to gath­er ide­al an­ti­bod­ies, em­ploy­ing B cells as their sound­ing board, for use in sol­id tu­mors.

John Or­win Atre­ca

The Red­wood City, Cal­i­for­nia-based play­er ex­pects to sub­mit an FDA ap­pli­ca­tion to test its lead ex­per­i­men­tal drug, ATRC-101, in hu­mans in late 2019, and kick off an ear­ly-stage tri­al in ear­ly 2020. Bak­er Broth­ers Life Sci­ences and its af­fil­i­ates own 22.8% of the com­pa­ny’s class A shares — and all of its B shares — while oth­er big share­hold­ers in­clude: Hadley Har­bor Mas­ter In­vestors (12.5%), Bill & Melin­da Gates Foun­da­tion (9%) and Box­er Cap­i­tal (6.9%). Atre­ca is plan­ning to list un­der the sym­bol $BCEL, ac­cord­ing to a fil­ing post­ed on Fri­day.

Pre­vail Ther­a­peu­tics

Wad­ing deep­er in­to the biotech wa­ters, for­mer Co­lum­bia pro­fes­sor Asa Abe­liovich is tak­ing his Parkin­son’s gene ther­a­py project to the Nas­daq, look­ing to raise $100 mil­lion for Pre­vail Ther­a­peu­tics af­ter clos­ing a $50 mil­lion round just two months ago.

Asa Abe­liovich Pre­vail

Found­ed in 2017 in part­ner­ship with Or­biMed and The Sil­ver­stein Foun­da­tion,  the New York-based com­pa­ny vows to de­vel­op a broad­er set of AAV gene ther­a­pies for neu­rode­gen­er­a­tive dis­eases, with a fo­cus on ge­net­i­cal­ly de­fined pa­tient pop­u­la­tions. In Parkin­son’s, that means tar­get­ing the GBA1 mu­ta­tion — an un­der­ly­ing dri­ver of the (less com­mon) neu­ro­log­i­cal man­i­fes­ta­tions of a com­mon lyso­so­mal stor­age dis­or­der known as Gauch­er dis­ease. Ad­di­tion­al pro­grams in­clude PR006 for fron­totem­po­ral de­men­tia with GRN mu­ta­tion and PR004 for the treat­ment of synu­cle­inopathies, pre­clin­i­cal stud­ies of which are to be fund­ed by the IPO wind­fall.

Abe­liovich, who helped co-found high pro­file Alzheimer’s biotech Alec­tor, owns 10.1% of the stock. But Or­biMed has the li­on’s share here: Its 48.6% own­er­ship dwarfs Re­genxbio’s 9.1%, RA Cap­i­tal’s 8.1%, Pon­tif­ax’ 5.9% or EcoR1 Cap­i­tal’s 5.8%. Pre­vail plans to list as $PRVL.

Akero Ther­a­peu­tics

It’s bare­ly been a year since Akero threw its NASH can­di­date in­to the crowd­ed space from out of left field. In the months that fol­lowed, it added $70 mil­lion to its orig­i­nal $65 mil­lion cash re­serve, wooed Gilead vet An­drew Cheng as CEO, and se­cured an IND for the next phase in the clin­ic. And if it all goes ac­cord­ing to plan, it will be cel­e­brat­ing its biotech an­niver­sary with $86 mil­lion in IPO mon­ey.

An­drew Cheng Akero

In the S-1, Akero once again out­lined the case for its FGF21 ana­log — in-li­censed from Am­gen $AMGN — in dis­rupt­ing dis­ease pro­gres­sion, start­ing from the fat ac­cu­mu­la­tion that is be­lieved to cause cell stress. Af­ter treat­ing 83 type 2 di­a­betes pa­tients with the drug, in­ves­ti­ga­tors ob­served bet­ter plas­ma lipopro­tein lev­els and in­sulin sen­si­tiv­i­ty, in­di­cat­ing “the po­ten­tial of AKR-001 to redi­rect calo­ries away from the liv­er, re­duce liv­er fat, al­le­vi­ate he­pa­to­cyte stress, in­hib­it in­flam­ma­tion and re­solve fi­bro­sis in pa­tients with NASH, as well as re­duce sus­cep­ti­bil­i­ty to car­dio­vas­cu­lar dis­ease” — a ma­jor cause of death for these pa­tients.

The biotech, now lo­cat­ed in San Fran­cis­co, al­so dis­closed that Am­gen gained a 7.8% stake from the deal in ad­di­tion to the $5 mil­lion up­front pay­ment. Clin­i­cal mile­stones to­tal $40 mil­lion and Akero could pay $75 mil­lion more if the drug makes it to the mar­ket. Ap­ple Tree Part­ners is the biggest share­hold­er here with 18.5%, while At­las, ven­Bio and Ver­sant each claims 15.2%. The pro­ceeds will go to­ward a planned Phase IIa tri­al con­firm­ing this the­o­ry as well as man­u­fac­tur­ing and oth­er ef­forts to beef up the clin­i­cal pipeline.


Im­age: Shut­ter­stock

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Mike Grey. Mirum

In $86M IPO pitch, Mirum spells out plans to turn Shire dis­cards in­to or­phan liv­er drug suc­cess­es

Mike Grey doesn’t have any time to waste. Hav­ing re­gained con­trol of two liv­er dis­ease drugs from Shire and po­si­tioned them for piv­otal stud­ies — five years af­ter first hand­ing them off in a deal to sell Lu­me­na, where he was CEO — Grey is steer­ing Mirum straight in­to an IPO with a $86 mil­lion ask.

Not that Mirum has spent much of its $120 mil­lion Se­ries A cash since launch­ing last No­vem­ber. Ac­cord­ing to the S-1, the Cal­i­forn­ian biotech has burned through $23.3 mil­lion as of March, but ex­pects ex­pens­es to pick up once their clin­i­cal work gath­ers steam.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes weeks af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.