BLUE - Earnings call transcript Q3 2017

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Operator

Good day, ladies and gentlemen, and welcome to the bluebird quarterly update and ASH 2017 Abstract Call. [Operator Instructions] I’d now like to introduce your host for today’s conference, Ms. Liz Pingpank. Ma’am, you may begin.

Liz Pingpank

Thank you, operator, and good morning, everyone. ASH to we quarterly new believe in of us as as data joining some that the important our for discuss results our well contained Thanks abstracts. amount of outlining We issued can the our on release data of morning, Investor section and find Relations the the website. a you this release press conclude remarks, will for walk then through will today’s follows: we’ll share The Nick then preclinical and is agenda and Nick will the Q&A. clinical abstract up and as call make a update some call opening open the will for

are whether statement. cause Before trial discussion under of and uncertainties me outcomes per the EU. we to actual Reform statements and could for that or begin, review results. thalassemia number subject let a Securities involve that from submission on changes disease and Private statements trials our Act or risk the results forward-looking particular, the improve to sufficient safe be will are in risks based factors harbor XXXX. differ that Such expectations are Today’s and that of will in to the regulatory of Litigation contains marketing current mobilization the risks current clinical U.S. statements, planned SGB in sickle approval including cell clinical materially In LentiGlobin and severe projected as patients protocol, assumptions

contained filings section SEC, with factors our which on in these website, our of Relations risk www.bluebirdbio.com. the available Additional Investor information concerning are

by the to we so expectations do change as While our we to statements law. disclaim specifically even may elect obligation any forward-looking required future, update as in except

to to, I’ll of statements on Nick. any now as turn You date representing our these over rely expectations forward-looking should it as today. subsequent not

Nick Leschly

call for and joining thank this you, the Thank you, Liz, morning. on us everyone,

context cell in abstract generally the call the in study. included for our In the for or a we’ve emerging on Our provide quarterly webcast as is data some study on and well to ASH our we’ll In focus highlight as important limited was our it some in past, sickle releases. done particular, data abstracts. data. disease the a not thalassemia XXX felt of we to share case, progress But objective today XXXX updates new quarterly our on

Our X relevance the that it’s need always by hope. we come are And we of What expectations goal new to dream bring Blue data, True all captures everything off It’s into our we we’re to simple simply the questions. company now is put, patients. we about and cover is dive And talking MOJO BLUE here? in. And what that the going to can idea why ASH? hope Before is families that patients the into inside doing make for desperate start about the the do true. about data? captures

both how So talking notice as ability continuously While do is biology. XXXX areas. of We learn team blue much platform success as disease succeed? therapy innovate in that about will you’re we in key spent these believe about our to hopefully our we about underlying gene learnings both the well and lies

as front, our On technology programs. our well on the seeking we’ve of to improve to aspects manufacturing all product optimize been as

mobilization. will plerixafor for PIX-kinase manufacturing shared using of cell into research The and new Specifically, – for share plerixafor manufacturing this inn LentiGlobin. the edition our BCMA, we into call sickle process disease our

challenges, patients. understanding continually genotypes of deliver point Today, thalassemia, both biology, technology biology we deep our understanding learnings disease believe the innovative patients is been of our best we the in and to cell. sickle deep and further share in by innovations recently, both financials for a cell protocol and more our progress. recent our approach. simple, in going pathophysiology operation and to announced we’ll and using that The focused in changes on cell phenotyping in our We we’ve of On disease implement front, in the quarterly and inform integrating sickle absolute addressing

of As set CRB-XXX the disclosed our the of expansion the year. second-generation Phase quarter, BCMA the the other significant of we cohort first well bbXXXXX. patient we candidate progress first in in at as trial the the we’re of Notably, a of patient as treatment of this year, the goals bbXXXX beginning related achieving progress I many Phase our trial, program to treatment we through I

had interim trial showing endpoint. early in October our out Phase of our that data in met patients from disclosed also II/III primary We the XX the XX of

also therapy program cell engagement we – known as formal enabling week, and from on our early FDA advanced for last plans. regenerative received FDA, designation for the sickle also development medicine the Just our the

continue with cash Lastly, well of the sheet, on XXXX. taking funded balance runway we $X.X be our to billion into

company. Our the of is focus moving and forward exciting clear evolution an

We’re X-plus commercial for XXX launches, pipeline very exciting nearing X-plus products. and company preparing the XXXX towards and vision. future X-plus projects, and times. filings and our product commercial commercial It’s building

let’s data. data. ASH bluebird be shift placeholders be biggest going – are with bluebird’s And with our ever. gears XX focus clinical Now Most of the on abstracts ASH the happy this is say programs. this to the is to and no biggest preclinical that presentations and to across I’m going

important public abstracts However, contain several made of some data. today and new the

study, to the front, Northstar. an On HGB-XXX the also is as known updated there

known But at provided today, providing on on be a studies, plerixafor front, data data Northstar-X. there program On mobilizing we will agent BCMA with including both sickle in patients the few cell be is clarity, sickle the But using disease. of disease weeks. ASH not in on will either updates an cell new also update on the of the as or study, a for safety as the HGB-XXX

in we contracts several with have Boston to preclinical preclinical Hospital disease. also related We our briefly in abstracts, and on today program touch one will Children’s sickle be which cell – will of touch – their relationship

promising any in give protocol disease. you let that step clinical quick free forward, of On the path The shift patients? product the review Before the I review, going cell XXX sickle On Mohammed? data to With me whether regulatory using will to I improvements on turn the and to that is are for sickle is space difference question Mohammed the data plerixafor early data. our for our is ability track good mobilization. changes it updated disease make towards to news to remains Mohammed based call our including clinical preview, a a over highlights. cell on the The hand over data.

Mohammed Asmal

very Thank Nick. you much,

all copy product stem and These known me Phase patients And X vector. genotypes the studies overview Northstar XXX in the today. III with dependent. using HGB-XXX, is using and our proportion of the HGB-XXX, the by and include known study a Let I the non-beta-X/beta-X does I/II new The ongoing. will the is The the the genotypes studies ASH our while present our form basis as both primary transfusion with an quick our study thalassemia. of that filing cells start process, conducted manufacturing in data. as The drug also any X study patients the provide increases Phase not XXX process. conducted improved of number as in XXX HGB-XXX, will of LentiGlobin on mentioned, ASH study manufacturing original abstracts study update Northstar-X, of is which abstract substantially European Union. Nick

with is patients Phase our this also who will not beta-X III today. update process. manufacturing patients have Northstar-X, known genotype. the no XXX conducted HGB-XXX, as we thalassemia in is study using make study So the These improved

treated announce been the with LentiGlobin. We and year, first patient track to has will on are when start XXX this

Now that you’re an Northstar oriented, I’ll overview through of the walk Study.

the And Study. study XX.X X.X the median study. to been the the X.X As an of XX transfusions from XX with non-beta-X/beta-X follow-up per have Northstar ranging total visit, TXXQ a and for in patients to mentioned patients per deciliter At today, genotypes. beta-X/beta-X XX.X of XX been X a from median had X.X genotypes, these include grams hemoglobin the deciliter. X patients treated months. with ranging from have months. patients with they grams hemoglobin to Of X non-beta-X/beta-X last with have free update abstracts XX genotypes patients this

other non-beta-X/beta-X the range patients and received the end in between low at and DP have Notably, in respectively. X these other. and X.X the in annual X by the XX% VCN seen volumes in TXXQ the genotypes study, The drug There strong is production product the X.X, X reduced patients correlation of studies. with hemoglobin patient transfusion XX% a thalassemia

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the the patient-to-patient of improved achieve studies. immunoglobulin and expect even and benefit total transfusions process potential Importantly, against patients free we mitigate levels. of with or production a Using in clinical higher data to Northstar-X more this these to an Northstar-X process, consistently our robust from normal proportion TXXQ become to implemented enable near normal reinforce variability manufacturing

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described we timelines beta-X/ the States prime we on to in beta-X Therapy forward. data the of event more and authorities and EU, in general based the XXXX, full genotypes In plan file In therapy and approval basis have file approval and in XXXX. designation the studies, plan genotypes XXX. Gene on non-beta-X/beta-X through interim NorthStar we’re agreement the working and our provide Northstar-X States, United from adaptive from data on European study. conditional for the Union we to The the Day United pathways the with a patients clarity available in path We non- As on have the The including breakthrough regulatory framework to from with of for in patients XXX designation

to disease. sickle switch cell gears discuss now Lets

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clinical apheresis cells experience are mobilization and with is initial number the well of Our plerixafor quality both and improves suggests collected. tolerated it and that stem

the We will profile of on populations present additional at LentiGlobin and in impact data cell may outcome. date, cells condition. characterizing transplantation is to ASH, comparable of have cell these clinical To the different safety

preclinical discuss will Philip the abstract. Now

Philip Gregory

bluebird is look done clinical of and Seattle. preclinical we we ASH the highlighting several development preclinical work to and I future the vector simultaneously core bluebirds to quite more importantly, our progress. a hemoglobin to our hemoglobin. to sickle levels and novel of or immunotherapy deliver patients of cells. sickle fetal disease associated XX% lentiviral worth of These of results just Reduced cell by as David Boston resulted of this HSE HPF F, and vector mouthful. at programs to as forward in Children’s signs at hemoglobin Williams The impression hemoglobin study is uses by XX% and hemoglobin Put and disease. generated Cambridge from followed a symptoms team approximately abstract in collaborators results technology disease cell fetal light of increased the programs XX%. editing by favorably and novel of data data into these our by of XX% is RNA, with which very in XX% from well cell all shown into HPF Hospital address and the And The some detail known suppression of simply, in sharing with to These promising date Mohammed. in similar work Dr. expression comes with Boston of presented S. scientific on exclusively sickle Thanks, Moreover, have preclinical S vector of that to by in to hopefully modified with change. this academic dramatically ASH showed preclinical cells blood under to which a ranging representing which shared abstract his gene team are conducted preclinical a our is disease-causing compare increase some targeted approach this experimental Children’s This have conditions. Hospital, levels team these adapted further HPF the highlighting lentiviral and One at approach from the as pathological technologies,

cell Our may represent the sickle sickle manufacturing to a to advances powerful through novel disease, patient biology, made all earlier. which upon stands cell which respect you a have with therapeutic approach and we advances management, Mohammed walked

the forward Williams program details clinic the into information to that, to abstracts the in at program to hand preclinical anticipate over more we advance ASH, of I’ll and data back progresses. Dr. Nick. with call shed be will And pleased team, as preclinical ASH. the look and exciding to providing plan his with We’re this of XXXX. summary And We collaborating

Nick Leschly

you, Thank Philip.

remarks, trend been mentioned And – and quarterback. busy ASH my clinical I has productive of of opening with trials. As certainly this ongoing all our in abstracts incredibly continue our nearly will updates an and XX across clinical all that ongoing accepted

to we we’re clear ASH, disclose is here will at make sure Just to an overview. what

disease the in process follow-up follow-up Further updates EHA. on been longer from An that the and update basis on study on we the have as the improved filing follow-up the patients showed with on EU on form the include that manufacturing B. XXX Northstar-X LentiGlobin will XXX, group will primary which more – the two longer basis at will of XXX shared treated study sickle as just Additional patients or include patients we XXX well a few cell

some additional will some data product subjects plerixafor mobilization. collected cells several We C, have for product, groups drug in had using their who

have on on We at will that a patients included ASCO. follow-up XX update BCMA program will presented an the also

Sunday, and on our on formal organizational December XX, And Lastly, clinical questions. we’ll detail will and webcast look That provide where a investor of Operator? some join will host forward at part to I analyst event content. to more our he us companies of context hope you and ASH, progress. take

Operator

first Instructions] comes Our Salveen Richter Goldman from Sachs. [Operator question from

now is line Your open.

Salveen Richter

my taking for Thanks questions.

showed with just us these at cell remind tell given program, just point? X.X your what this time sickle Patient So to achieve And level are? us what you patient? you’re to what’s XXXX, X threshold or this the for And months, could what of trying us patients to age remind regard the two at treated the patient ever age the here the first

Nick Leschly

thank the appreciate Salveen you so questions. Okay, I

you So the can address then Mohammed, first we’ll the and questions. step other through age, maybe

Mohammed Asmal

Yes, in older are so including the in followed TXXQ range. that cell production, any report, the are age abstract in time studies sickle at represent disease. regards point subjects and HPA so range than the that the XXXX. with TXXQ treated to highest Older Then in that traditional production our patients of the two does patient XX results

than XXXX. So XXXX, not greater substantially greater than but

missed lot. a I So

Nick Leschly

Salveen. third the question, What’s

Salveen Richter

for context, we threshold put we meaningful? in long-term should the trying this achieve when you’re to level TXXQ this how X.X about be here think to

Mohammed Asmal

question. excellent an that’s think I No, Yes.

of of production, The have play approximately resulted to think time. clinical out to data subject that the X is in X a I how results we question grams and that biochemical our of to part that is answer TXXQ patient conversion to and had trade. essentially over the see So evolve we how answer short that XXXX,

I goal to forward. go admirable be a very think will

that significant data, production, with on we have know attenuation the I have hemoglobin approximately think based F XX% their individuals that of symptom. total of historical

for. are for TXXQ, hemoglobin would something shooting behave that be trying for to similar we say our would which similarly I So F goal

Nick Leschly

of it’s Salveen, a But really we’ll copy wasn’t But primary translate very easy unless can challenge. some little this up product the don’t we with us level, as address in we beta with to This see the you is need to provide of too how we for all and a And It the get into was nice more emphasis go. can XX. obviously. think number XXXX trajectory have is here drug connecting little really data. of as but sort we the get with a that into to and so And context visibility certainly the number that. in-vivo point to our more has address copy can we early I challenges,

Salveen Richter

and as I can have focused might But early on on any what endpoints with update the be well. one too And you follow-up just Right. do if cell? this FDA may sickle here

Nick Leschly

Yes, you’re right.

we little You but appropriate with information, – eye of the engaged most too got we has right and at a been evolve of more We But we’ll designation. certainly quite the early. to providing you now, with that know with consistency. mass first looking engage of the will, on And the that us, this regulatory agency a data, data critical agency. keen on sort we’re Salveen. as the is asked that if do one and continues what’s thing question level are recent

and So those around are They and concerned will this significant certainly be globally. disease plight very sickle cell engagement. country aware pretty in the of

show a we to for be study. up if the registration is So engage and at threshold appropriate dialogue about we very able with a least good data, feel, constructive what in active we’ll

Salveen Richter

you. Thank

Nick Leschly

Salveen. you, Thank

Operator

from And ISI. from Evercore our question comes next

line now Your is open.

Josh Schimmer

cells what for factors talk other that the percent Thanks factors but taking that between question. the number Can are you numbers in be difference will peripheral the copy cause different? determination, about be Clearly, measured in what’s blood? those cause the might engraftment the vector to a infused my versus will important

Nick Leschly

you. sorry. there? A Can little you restate least Josh, the trouble, just at am I’m question hearing I

Josh Schimmer

Sorry.

the difference a caused from what factors and aside number other those what that engraftment, measured between the understand blood, copy in numbers? percent cause between to actually will forces infused are cells the a trying difference vector the what’s Just in

Philip Gregory

is Josh. Philip. This Thanks

number the – of a that While of I factors product aware think you’re the peripheral impact between relationship as the think measured. drug there’s I and VCN

Some whether point course, have of cell. of the the you more they their of phenotype percentage the And including, are true dose. those feature the we’re cells, that include required dose, be stem primitive cells a cell out second was long-term provided that quality absolute as to now a about of much in

And think those make big transfusions, as recovered program. across changes a engraftment. well a are big to critical And difference. those preharvest status the difference you disease, in cells cells we sickle to I And as stem believe, the quality disease to and the include our as of clearly so makes recent the cell of seem ability

a each are But you address it’s complex. are of that think is set those walk I things, many one changes like to of So fairly through trying criteria.

Mohammed Asmal

Josh, from why to at bit data the number move marrow maybe of off, of dig line a bone And regard. the to to of a see really in we’ve of any harvest address higest a to finish thalassemia objective also is level – that these there. allows the trying to start sickle cell been so at sort we’re more part apheresis factors almost just into specifically, see little to excited highest that understand level, consistent actively the top reason and certainly the apheresis is of us to some more this and

step exciting an that’s So forward.

Joshua Schimmer

what actually in And peripheral cells capturing are that and measuring report when assessment? VCN, you you blood

Nick Leschly

So these are basically. PBMCs

peripheral a cells. just it’s So

Joshua Schimmer

transacted only advantage And an that cell cell blood the cell has or that? peripheral survival is red does successfully over the have a

Nick Leschly

Yes.

So we in blood be good believe So the than we another be think that will don’t in difference marking marker We don’t give marrow active not think, peripheral be other cell. the in should I a the versus any, of very that will engraftment. transgene, bone there any

Joshua Schimmer

right thanks All so much. you

Nick Leschly

Joshua lot a Thanks

Operator

question Company. Our Cowen next Schmidt from from comes & Eric

Your line is now open.

Eric Schmidt

think do on on just indirectly, factor sickle Thanks outcomes? the cell touch age you progress. in a question disease Maybe question. that for taking driving in better Congrats in a study is to that

Nick Leschly

Nick. I it. appreciate is This

as asking to thoughts. has will see to tell treat you’re some us Mohamed look think patients. over speculate again, But he I here. if time here to we I’ll maybe younger But cautiously start

Mohammed Asmal

Yes.

tell. As Nick will said, time

don’t much But gene that between just for And we for particular fish. can with kettle What different older is, in think that transplant. and we patients. data better a cell or a in I difference is younger is younger huge certainly, general, cell sickle for transplant say therapy. patients disease stem stem have patients do cell with

see will we So younger how this into patients. evolves as go we hopefully

Eric Schmidt

at Okay. like correct going group those to get of none be VCN. plerixafor. Then in patients have several that cell patients clarification, transplanted? treated C yet ASH drug vivo just with sounds to we’re but for patients Is product sickle It

Nick Leschly

of but the information drug in time you’re vivo we right, product the at will actually, some data. be Yes, they allow will

Eric Schmidt

patients yet, of Nick? Have any you treated the

Nick Leschly

much can’t speculate the a time I at ASH. I the full of think study really that. give stands we’ll on won’t update on where

Eric Schmidt

All to right. don’t lose want And focus on bbXXXXeither. I

You talked about having additional.

Nick Leschly

we. do Neither

Eric Schmidt

additional know patients And follow-up? treated Are going cohort? going in be to you have or that should any what so for longer-term I in we additionally X looking months include you’re to follow-up. the

Nick Leschly

And of of expansion Thank me provide you the in long update none to Eric, sort those or be we far enough cohort, – cohort. know, of patients patients we’re on XX so provided update. were the initiated as the – the detailed you escalation providing but any have that will kind

be will to context X to to a significant understand durability it update be able to So the of patients from pretty months across safety. more these everything in response

So about next Celgene on And excited and look both very program. BCMA that. that sense, the are the at good us

Eric Schmidt

you Thank

Nick Leschly

you. Thank

Operator

JP comes Morgan. from next from Cory Kasimov question our And

line is Your now open.

Cory Kasimov

the Eric you enrolled Can my whether patients what good the trial. about, pipeline. group just questions that One say July. abstract asked was since not sickle thanks morning X and as on taking abstract? across the the Hi, cell to form The question more you’ve progress to of C entire than follow-up or good

Nick Leschly

let’s not not let’s Again, if you speculate. don’t mind,

of at ASH on an fullness update We that at that. provide time will the

we and to and go to be want of we One trying very trying given with so that all our the cetera, scheduling emphasis the is for data numbers the this studies, and forth, transfusions, to it’s understand few and to variables the understand all things prior know across and et these able is really where next.

is abstract, So enrollment proceeding. is you’ve seen the

is will the outlining update most And But to the we starting so, got emphasis consistency so a on and if and path of say. a this then that specific we’re that. data point we’re from a appropriate can try and to to understand regulatory do overall see view. like aggressive challenge what’s addressing provide here And we’ve we we

Cory Kasimov

pre-infusion then abstract required of XXXX X months understood. updated have they receiving blood LentiGlobin? X XXXX, and transfusions for in the the patients And the prior to patients Okay, that been regular were

Nick Leschly

not. No they were

Cory Kasimov

not. were They

Okay. And lastly, the BCMA quick one just on program.

is initial terms this should For study? of trial XXXX size that scope much study, to look the the like expected and of bbXXXX the in product, we

Nick Leschly

much Yes, with on modeled it’s the XXXX. study initial very

Cory Kasimov

thank All you. right great

Nick Leschly

Cory Thanks

Operator

comes Jim And from Birchenough from our next Wells question Fargo.

Your line is now open.

Jim Birchenough

express as congrats TXXQ so can benchmark is patient we and the just level hemoglobin, the for results on their percent wondering of Hi, XXX? earlier the taking Just progress, thanks for a to question possible Study from against XXXX, it total

Mohammed Asmal

ASH be will in we the certainly so that Yes, doing presentation

Nick Leschly

this at So there. point in it’s time. not in

shared same So but that we trajectory the across of speculate you point.But on it, the we’ve can past this see, the patients. as the can’t it done we’ll really we Jim, here at in do

as that a know the you You will understand allow to percent.

Jim Birchenough

say study patients. second just on she about cell on relatively sickle an those patients specifically? then get and than study for be additional And you XXX, we should X on those be from And – patients should Will can better to trajectory third Paris? anything the XXX update patients what seem a expectation our

Nick Leschly

we Jim, it update provide will the the we’ll cell certainly this all sickle right on expectations, our an and study. XXX case, update of way studies, the now, and think is only the I XXX, part yes. are in they patients XXX in as XXX

highlight seem been prior be really can’t better to So of But the those is, on doing trying those transfusions, not. speculate obvious I in who there and did that. had we’ve are who think consistently well, patients to than benefit

group patients. we’re that additional and full context on provide again, the to also So we’ll the on follow-up the And B variables. trying an out these update in

Philip Gregory

refined of also the were treated it’s our process. not XXX Yes, manufacturing with subjects

results. superior is we and think different will process that So get

Jim Birchenough

into just a see we When cell some we it for see maybe the like clinical BCMA you When product? of side development? data beyond moving cell controllable therapies. final the question therapy cell should got business move interesting And those therapy some on seems and of might on preclinical bluebird

Nick Leschly

like to you would handle one? Philip, that

Philip Gregory

we’re we’re obviously, the preclinical of beginning that to about. So excited very some show data

be sure As Those we’ll exciting you the approached obviously editing T-cells pointed use as to as we out are of those, client with CAR and update. controllable well some technologies. T-cells as And both on drugs. using

Jim Birchenough

question. Okay for thanks the taking

Nick Leschly

Thanks a lot Jim.

Operator

comes question next from Harrison from Morgan our Matthew And Stanley.

line now Your open. is

Matthew Harrison

X can drug I to patients? cell I guess, these doses X how of And product. much sickle you had expect X then comment additional you first question, can both on follow-up think those patients also,

review different I think what of have than Can that’s you just follow-up. on from comment other the patients. And one we then some there? see the

Nick Leschly

those you X? Mohammed, want to address So,

Mohammed Asmal

I Yes, think incremental. the will follow-up be

think presented be the at major time they imagine X next in will ASH. can point those I patients probably for

In terms drug. X the of

Nick Leschly

It has be more specific. lets to be –

to X one patients of One X months. be months, will will close be the close to

Just to give a specific.

Mohammed Asmal

have the And the or products drug of more drug vast patients sickle X actually then X majority bone from derived marrow. acquire of terms so actually the in

doses multiple bone in our we for required patients. achieve cell adequate marrow have general, to harvest So

you So this is very one typical. And mentioned, is as them apheresis. of move into to

Matthew Harrison

the think And from then a just around is Perfect. on had it. process apheresis. there that Can one I you That’s any question or event? the that clinical apheresis relation Got process, And you the to if of event abstract helpful. after not? the comment saw sort apheresis

Mohammed Asmal

think individual marrow so sticking the harvest. with Yes, did largely to I this what’s in bone particular associated have abstract,

as harvest, marrow were also But they in the as in post harvest other patients what speculate So highlighted mechanism it’s this exactly well we bone too. of to that the numerous hard was.

So it’s frequent very after cells. unfortunate

Nick Leschly

Nothing side. new on the apheresis

Mohammed Asmal

Yes

Matthew Harrison

Perfect thank very much.

Nick Leschly

All right thanks Matt.

Operator

comes question Dane from BTIG. next Our Leone from

open, now is lien Your

Dane Leone

me. Two from

patients the months? enrolled study, for you the was it into the there format – be can from And give having perspective for the being, terms of safety in in one on move for you’re is to looking any more prior first the u what the specific a in The the what products study? comfort that for XX

Mohammed Asmal

Yes, was question. that good a

reasons difference to major these the some lots think, them mobilized. is typical mean can this I had we to getting be implemented general of suppress was was that which our for month in period they this during fact, prior them were only that’s no. The transfusions, in of patients X-month helpful the I of of first suppressing leading X- question, at major period. one plerixafor So

question, was that then the the then And second safety. that And in second So respect. only the

So looking we’re safety. a for

So safety. all for looking we’re safety

safety patients all were complications. events, these we potential for monitoring So any

receiving that which count their counts the white experience is Now and cell in And did for And of these were obviously, patient I follow life- criteria monitoring this the X patients patients very increases on not you have tell that these GCSF so cognizant in or commented most – obviously very threatening that patients follow them and the cell can that the relevant, severe the what doing develop crisis blood after white were same you these did very significant as

Dane Leone

the and would clinical update has would you Can you what gravitate in perspective, your the for be of us or data can an ideal outcome formation patients? this so, cell. what measure sickle with And be a the clinical what think developing on protocol you your will think clinicians thoughts around regulators towards these

Nick Leschly

here This is but then fullness debate standard, allow different on what, what specific disease more can information ASH, speculating. foremost little behaving about for sort consistency and pivotal various, which endpoints and of options get ties the in call are the are we a the of in various more us will the what with engage first are just data through around the of But about not of to conversation extensive the Once that. really cell to is have outcomes can we of Nick. that to how we study get cautious the sense be Again, aggregating to the of then a again, enough this trying variables we part at sickle agency.

cell that. direction. some engage agency can is best on do to be has right creative in Like very on a the options really shown step sickle we we to But the open in to early said to for this a certainly too feel signs earlier, patients. So sickle the

Dane Leone

much. very you Thank

Operator

And from Partners. Schmidt Michael comes question our from Leerink next

now Your line is open.

Michael Schmidt

at I was for than follow-up was disease what was the cell X think me on patient? XXXX patients. X it had it production just Remind said saw you you with a XXXX sickle what this lower I lower said the Patient months?

Mohammed Asmal

Yes, marginally lower.

probably head, have less but XX% of top my I about think So it was it I – don’t patient. approximately on

Michael Schmidt

that’s levels? hemoglobin is or with overall it hemoglobin All absolute important right. HB the – production relationship And the the

Mohammed Asmal

bit Well, both. is probably the answer of

some nature. an issues, that that solve a I to level of is is fraction being think, obviously at a to there level of having globin by important the Then increasing cell substantial and an of globin in going corrected that sickle problem. is is sickle problem anemia anemia, be

to that set that think XX% correction both. hemoglobin point. targeting we’re the as a previously around to more will the come we’re total Mohammed I So said, or levels hopefully achieve hopefully with looking And but of

Michael Schmidt

a medicine And impact that might of from question is, designation? how breakthrough then therapy just something curious the Sounds advanced regarding may the therapy good. differ that I’m And like and designation. what

Mohammed Asmal

more we engaging an get is Yes, bluebirds feedback regulators think what as the very endpoints. to FDA of And trial frequently us is get proactive really potential design I opportunity strategy feedback with speaks to I think on to as our for this this frequent with for much they certainly engage regularly think and can. to as our

Nick Leschly

the path? what a The is at study time very point what one here have manufacturing should? news And engaging How or of does good us agency it’s relationship pretty about with whether spectacular It’s with or the had but dialogue, the what’s registration be try of, specifically. do clinical. main good what that should emphasis to we across, think obviously early development really you sort is, also

before fundamentally The really engaging data a way. that interact. in this agency don’t we is, the So strategy an key we I changes to certainly have have how it is important think like But step. we with

on to So on what seeing. we we’re we think here’s to as the get what going to forward and right path data here’s the to based how is supposed things

a step this So direction. that in nice is obviously

as comment You’ll for we sickle. can, soon hear we about plans specifically more and more at ASH. U.S. development as we thinking And how on European

Michael Schmidt

you. Great thank

Operator

question Nierengarten next David Wedbush from Securities. comes our And from

Your line is open. now

David Nierengarten

cells I here. curious I’m in the about But most can actually that ask CDXX phonotype. a lots CDXX

is that look stem from again cells? high Thanks. of low in atypical on those that And or similarly different patient known they it CDXX cells studies with of that it prior off, cells? Northstar-X numbers primitive CDXX with at particularly, plerixafor number – the where First phonotype degenerates then, you more that and a

Philip Gregory

the research on we’ve understanding CDXX cells, such in how with that ultimately very phonotype interested as been features correlates have engraftment, vivo top, and the the in at starting Philip. and level is VCN. of This

is As think marrow-derived of new. I the we don’t on stem that you of apheresis done disease cell people have there pointed other that study. actually have out, cells sort is data comparison I bone and sickle think versus

GCSF analysis So improve usually is one a used that nothing sort cell that’s exactly combination we’re respect mobilizations. done types plerixafor number and the quality stem now to those standard both these of doing although I the in of stem that’s cells board. to, course, across think the reasons and reference in to And the mobilizations. really With the of Northstar-X is, of with same to are subject, of

Northstar-X to whether the that for in So characterization that that respect are of mentioned of as expression, think that’s stems which population, the well looking subject. expressed remember cell we in type those is as definitive we’re CDXX and level you present with a lineage that analysis good there we specifically cells of any

So of product the all be and part sickle. think same predict is across as in it’s important we this as the the drug And to to well to patients I can understand able outcomes

Nick Leschly

between the right, said, and David, and And it’s is thing sickle difference from. we’ve we is major is Nick. this the glaringly The get obvious where cells

to is compare be so is understand this trying both. across this. And unusual time much spent able So to situation an to this why we

It you think And apheresis. dose? that in out eventually bone I figure do to starts is and about is how to So in being it really able also new that to versus think different very speak sense, how interesting. marrow

compare going to what’s to of sides very in both or having is fundamental meaningful understanding more to of so we’re against we starting think going And sort on. unveil unravel be

data come more continue be we to as these on to able get that, across more variables. look So to certainly patient

David Nierengarten

Okay thanks.

Philip Gregory

David you Thank

Operator

question next Matthew from our And comes Luchini BMO Capital. from

Your open. now line

Matthew Luchini

hear , Congrats side a kind if little slightly from baseline could at was progress, I of little on that about X notice just wanted anything but XX color you mobilizations that of or secondly, of it’s got how obviously, thinking copies patients, her patient us at X same a cells, time here, patient the patient about different point? point VCN even that you’re a this bit point? looking And Patient was there’s at from him remind patient, and on view you of at we’ve or And three X.X on provide got peripheral bit maybe that maybe the being, to range, curious from more the one, X X on at significance month. early just can where first for so experience. you little XXXX, you then of lower bit a the the time were so XX plerixafor a I’m X.X if times

Nick Leschly

So the one, the variability can Philip, first you if you address will?

Philip Gregory

Yes, the the lower, to with What the mobilization, plerixafor to was – anticipate dose patient harvest and respect absolute is the variability that mobilization dose is some be I abstract blood which patient. we that lower. obviously in particular will subject, obviously, was explains in harvested can the peripheral say about from

drug mobilize patient. didn’t was in it the directly simply that effectively the So as

XXXX wants perhaps on to – subject? out the come Mohammed the With

Mohammed Asmal

XXXX at month. one

vivo impressive an it’s in So copy obviously stage. at number that

that’s one it’s a had some think was other. higher of certainly of major cells. our engraftment because product I we’ve issues I very mean, so the that considerably And than to promising XXX drug that safe is suboptimal transduced say in

in preservation observed stated vector what and definitely abstracts comparable XXXX. And this to as studies robust saw copy mean, the in so this speaking, so better XXXX engraftment in a comparatively cells. we’ve And to the we number patient – we we’ve then of the alluded much I other before, have that is and of appears

Nick Leschly

time at to engraft point. point, this at trying XXXX that Matt even even, just wasn’t And think I

The because not it’s measurement, So it’s really – what a tricky same, point is at points. we’re it’s that little – patients is the charts. in look almost you a a get one really comparison. it’s at is X.X the this But the time comparing to ultimately sort last of sort fact these to of the different even that where sense, little It’s off bit month to not just displaying at you’re way That’s them. here at so

Operator

next of question Bank you. Huang comes our from America. from Thank And Ying

now is line open. Your

Ying Huang

taking question. have morning. for cell. sickle I one Good a Thanks a a for

are Thank Phase done that’s you patient then finalized sickle the already product of in ASH, of So instead at trying your good that the you VCN in patient in only bbXXXX, what cell? have And you seeing within would include you. number a guys number the I? improve for case, in if the would terms job also of terms have but VCN higher to peripheral products, improving

Nick Leschly

So, thank there. you. the Can you address question second

an provide will ASH study the at on outlined. We update I

early As and with far as the development will be where go for we time. treatment, launch that plans another

discussing and that dialogues actively merits with certainly debating we’re and in the who what program. of big is pieces our data involved So obviously

So on really key hits there, the it, that points we’ve first Mohammed but hit all can it addressing the think I question you been today.

Mohammed Asmal

to thing of we vector where so product have – can do I drug it’s we summarize copy one of sort was terms think certainly peripheral I increase mean what from, I that to of the the is think better discussed, no, in from I we Yes, think addressing start number loss number. vector copy going a

increase so to step. plerixafor is trying We’re hope dose, cell the mobilization hence huge the we

and increase improve trying nature mobilization again, product, stem-like purity and drug the plerixafor the will be the or of hence, We’re the to helpful.

We well to myeloablation marrow inflammation and reception for more cells. transduced the implemented prior of made transfusions sickle are as trying two both the reduce months bone in the we to rigorous. hence as the optimally stem And

Nick Leschly

the seen the here. a it’s reduce all is these just step do effectively towards of try I slope. we’ve a the And one then Exactly contribution It’s combination think – what overall, what factors. thought a of and to that’s each So

Mohammed Asmal

you. Thank

Nick Leschly

Welcome

Operator

our Bernstein. comes And Vincent Chen you. from from Thank question next

is now Your open. line

Vincent Chen

the the on congratulation of mobilization. and questions Couple my taking for you Thank questions plerixafor progress. on

sense patient, the then mobilization, were First, might lower or follow-up. mobilization? transfused And to to Also a treatment? consider dose. to plerixafor where plerixafor? in what plerixafor of I multiple is there have plerixafor the receiving apheresis the And prior patients potentially the level of moving hemoglobin related rounds have can this did S plerixafor a world prior to they VLC he is Either a require that

Mohammed Asmal

the Yes, question second answering first first. the so –

was the think think to hemoglobin this I discussion to XX% our and and probability so do this patients the I to this crisis. beginning to people XX%, and process our patient is based below below prior hemoglobin all who extensive of goal, the So the on get with down is, minimize total S get F are transfused of

patient speculation As crisis, to a have say, to can also here, a this their after too bone a we All is the answer of what come the up causes necessarily harvest. speculative. patient marrow with to crisis complicated did

Nick Leschly

any then significant was an in not that view was this safety data board, I of think regard. the to both something. the Because safety here. and was of on that’s we also doing view important a not because that these we se. on point patients as it treatments this per as It’s really these Remember the we’re something purposes purposes. research apheresis monitoring initial apheresis unique

the forward. So something that’s from our in perspective that us way got moving of was not

Vincent Chen

And assays, how harvest commonly their the apheresis in to cells That’s in of generated human applied some of differentiation quality, marrow the then terms great. with compared other bone or from marrow see. example, assays? for respect to ability model do reconstitute cell to I

Philip Gregory

Philip. is This

plerixafor-mobilized fair very similarly methods stem other standard a history amount those is to mobilization. of they on the And behave there answer is cells. of So publications, short on

So plerixafor. and of plus course,

believe different. really – there’s a don’t substantially we process is this So

important think feature. So probably that’s I the most

promise I that great So this that’s mobilization of and sickle shown apheresis that in piece. think from really we’ve I specific way think this population a new perspective, has the

Vincent Chen

congrats again. you Thank much very and

Philip Gregory

Thank you much very appreciated.

Operator

from Thank you. And Amin question Jefferies. our from Biren next comes

Your open. line is now

Biren Amin

for similar have Thank patients questions. Patient Did of XXXX taking Yes. a to change for XXXX? XXXX and

Mohammed Asmal

knowledge. been documented. not This has Not to our

Biren Amin

don’t sickle would this how exhibit with to cell And so trait? think patients you patients the that do thalassemia compare

Mohammed Asmal

a think It’s this the number make that’s about. with think mean, we Yes, is, statement. an answer of I I I short to a reasonable would question. patients interesting have have definitive really actually to

Nick Leschly

Brian. data I need of We can’t the more that. really speculate understand on on that,

Biren Amin

be would license thought the insurance program, how what’s on just that And on to positioned the LentiGlobin? compared strategically

Nick Leschly

the leverage think technology Philip I have in focus outlined. have places been the has can to do around here that everything and as we Yes, that we platform our we

degree So we about how agnostic do sort we are some of it. to

the we sickle really do can So we best patients. to cell for want

we So program one thought of saw with when our and approach. ti on his was opportunity exciting speaking, already here the broadly actually we an

to look the Philip exciting. of some wanted take data is And so pretty here just it. And actually outlined, as at a

day, they ultimately, have sort is to the objective to of there is are end how these we’ll the for more of if at sickle have here. out, cell play our options And completely data-driven. see So

speed For right ahead full on certainly we’re now, both.

Biren Amin

Awesome, thank you.

Nick Leschly

you. Thank Welcome.

Operator

question Thank Barclays. from And our last Huidong Wang comes from you.

now is line open. Your

Huidong Wang

Thank taking you my question. for

you like would be but will be VCN peripheral that evolving, still it’s a benefit? indication you’re wondering just good looking if have any the know sense for I what So for

Philip Gregory

– I mean, trying Philip, going I on obviously X.X to be that number actually to But range. see. – this is goal a we final we’ve above had data-driven Yes, that what think certainly and we’re is based get VCN so into

the with to the so relationship going the number. the But is with And goal. be – that final that’s been target, you obviously far and been least if at will, driven by VCN

Nick Leschly

that patients. also is this little a thalassemia outcome The Nick. may get consistently we’ll threshold in the consistently that vary exactly vary from think important the for speculative is and too It’s news can and bit But ability good But that obviously above may our deliver an a higher to number that deliver we cell, to very all the good Yes, is. is early thing. the it’s we is, higher is something and what hope between. sickle higher

Huidong Wang

the And cell. Great. one I in regarding sickle have question

do see go know compared in how yourself year. two I space? independent you the programs clinic to will to later So competitors are there this this

some give can you thoughts? If

Nick Leschly

that that program the clear, program. be about to regulates just we talked so Yes, in

is technology. there So

editing sense is that sufficient challenge the approaches the desirable that which companies editing I which as outcome. the drive it similar and phonotype. introduce outcome. drive achieve is creating of they target and regarding think hits of that the HPA try They The many same have try a Although in editing that that a gene number mutations the approach the interesting is

of to every make is the cell, in that changes gene actually the So phenotype if you in drives cell right interested before fully you in. you’re the biology mutation it a will mutation the every has completely to penetrant be

the XX%, one community. the reason has that’s XX%, XX% we’re the the think been by change seeing I editing gene XX% reported of versus

So we think that competitive. program is very

we obviously highlighting. today’s to both is this that on very how working has we that We’re too. terms to of and And in we’re deliver in cells. also abstract it have interested single terms that see approach, specificity of And for advantages program if easy in think gene editing But LentiGlobin which we’re

Huidong Wang

Thank you.

Nick Leschly

Thank Huidong. you

Operator

for showing Thank queue final at back I’m over the turn any this the you. And further to remarks. no like call speakers questions time. I’d in to

Nick Leschly

to for at cell respond. be obviously, questions, if much. follow-up have point, the I time. any my we’d everyone, any thank, And you out to we them taking and just reach Thank very you want just take happy to will

Operator

Ladies may day. and today, great this gentlemen, a all disconnect. Everyone, and you does conclude program your for have

bluebird bio (BLUE) 1 Nov 172017 Q3 Earnings call transcript