In the lat­est re­verse merg­er, Vi­en­na's Ar­sa­nis serves as ve­hi­cle for X4 Phar­ma's Nas­daq list­ing

Con­sid­er this: a small biotech pins its hopes on its lead pro­gram, which for what­ev­er rea­son lat­er fails. Then comes along a pri­vate play­er look­ing for a sim­pler, quick­er and cheap­er path to a pub­lic list­ing, by part­ly or ful­ly swal­low­ing the bat­tered com­pa­ny and pro­vid­ing its in­vestors a mi­nor­i­ty share of the merged en­ti­ty as some­thing of a con­so­la­tion prize. Sound fa­mil­iar? It should.

Paula Ra­gan

In re­cent months, there have been at least three re­verse merg­ers, in the af­ter­math of dis­ap­point­ments that have cratered the list­ed com­pa­ny’s stock. On Tues­day, Vi­en­na-based Ar­sa­nis $ASNS — which aban­doned its S. au­reus pneu­mo­nia ther­a­py this June af­ter it failed to pass muster in an mid-stage tri­al in­ter­im analy­sis — agreed to be the ve­hi­cle for Cam­bridge, Mass­a­chu­setts-based X4 Phar­ma­ceu­ti­cals to list on the Nas­daq.

The Aus­tri­an com­pa­ny’s shares on Nas­daq jumped near­ly 25% pre­mar­ket on the an­nounce­ment.

As part of the deal, X4 Phar­ma is ex­pect­ed to merge with a sub­sidiary of Ar­sa­nis in an all-stock trans­ac­tion that will cul­mi­nate in a com­bined com­pa­ny, in which cur­rent X4 Phar­ma­ceu­ti­cals stock­hold­ers will hold a 70% share, and Ar­sa­nis share­hold­ers will re­tain the re­main­ing 30%. The merged en­ti­ty will op­er­ate un­der the X4 name, and fo­cus on the de­vel­op­ment of X4’s lead ex­per­i­men­tal drug, X4P-001, in ad­di­tion to its pipeline of drugs-in-de­vel­op­ment for rare can­cers and im­mune-me­di­at­ed dis­eases.

X4P-001 is ex­pect­ed to be test­ed in a late-stage tri­al in pa­tients with WHIM syn­drome, a se­ri­ous, hered­i­tary pri­ma­ry im­mun­od­e­fi­cien­cy dis­ease caused by a mu­ta­tion in the CX­CR4 re­cep­tor, a path­way X4P-001 is de­signed to tar­get. The merg­er, ex­pect­ed to close in the first quar­ter of 2019, will en­hance X4’s R&D ar­se­nal in Eu­rope through Ar­sa­nis’ Vi­en­na fa­cil­i­ty, X4 chief Paula Ra­gan said.

Michael Gray

Ar­sa­nis, co-found­ed by an­ti­body ex­pert Till­man Gern­gross, raised $40 mil­lion in its IPO last fall af­ter ad­just­ing its price ex­pec­ta­tions. The com­pa­ny on Tues­day al­so an­nounced that Michael Gray would take over the role of CEO from René Rus­so, who has re­signed to pur­sue oth­er op­por­tu­ni­ties.

The Ar­sa­nis-X4 deal fol­lows sim­i­lar trans­ac­tions in the space. Bat­tered by a late-stage set­back in March, tiny Edge Ther­a­peu­tics $EDGE on Mon­day pro­vid­ed can­cer im­munother­a­py com­pa­ny PDS Biotech­nol­o­gy Corp. a ve­hi­cle for a quick re­verse merg­er on­to Nas­daq. Last week, Is­rael’s Bioblast $ORPN com­mit­ted to serv­ing as the shell for the re­verse merg­er of En­livex Ther­a­peu­tics. In Au­gust, women’s health com­pa­ny Ova­Science, which once com­mand­ed a bil­lion dol­lar plus val­u­a­tion, agreed to merge with Ann Ar­bor’s Mil­len­do Ther­a­peu­tics al­low­ing the lat­ter on­to the Nas­daq, af­ter Ova­science en­tered pen­ny­s­tock ter­ri­to­ry.

 

Roger Perlmutter Merck Investor Day 1

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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