EDIT - Earnings call transcript Q2 2018

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Operator

Good afternoon and welcome to Editas Medicine’s Second Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at Editas’s request. I would now like to turn the call over to Mark Mullikin, Senior Director of Finance and Investor Relations at Editas Medicine.

Mark Mullikin

afternoon call. welcome Good quarter our operator, conference XXXX you, everyone to and second Thank the closed for after financial Shortly market results providing press and our release corporate updates the quarter. we second issued a of Media of its & completion. replay the hours approximately section today’s available our be A on will Investors two website after call After remarks, open will we our the prepared call for Q&A.

recent of future forward-looking reminder, differ during under of report Securities which XX-Q, on this indicated the results purposes company’s various make by in statements provisions remarks constitute on those call file may prospects materially we expectations, including is Safe SEC. that with factors, various forward-looking most those and discussed from section statements the As Litigation quarterly result important a Factors of plans Harbor the Reform the for XXXX. Form as a about Private Risk Act the Actual these our of

today, only change. forward-looking any as subsequent addition, In disclaim views representing date. forward-looking our update revise statements We our upon any of any of statements not if even views any or specifically our views be relied to as obligation as and represent should

Chief Now, Executive the to call Bosley. I will over Officer, turn our Katrine

Katrine Bosley

of our Gerry executive Officer; everybody, our President Mark. Senior Hunt, our Chief our team, call. our Chief second including Vic I Chief Myer, for Albright, Thanks, quarter Cox, afternoon, Financial and of Hack, joining our Charlie Good Chief and conference several Vice Medical Corporate by am you thank us Technology Officer; Scientific members Officer; Affairs. for Officer; joined Andrew our Tim today

our medicine a broadly. field for particularly the and at company are exciting time for We of

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also clinical before, will we patients dosing to Institute registered we've our involve DNA be RDAC. process protocols will the addition is IND expect human the required the which protocol of trial and Registration with is review prior States, NIH's to transfer as or the National process gene United this the As Advisory FDA. need first known Committee with Recombinant NIH Health NIH the discussed to of by in the in the with customary

to requisite July, and in September. to conduct parallel Our which the for roughly data these RDAC the other meeting be continue each plan eligible with with we we filed the package been quarterly In for late is approach. scheduled that has always to NIH in filings take order

their resulted many review higher has bar gene essentially regarding revised you for human know, RDAC to of corporate As RDAC the and of of guidelines Institute their the fewer in Medicine recently of This protocol. transfer meetings recommendations NIH review. a

to file of know later October. We with will We if if then let in in our the review month FDA and IND meeting advance they learn expect will we will a at EDIT-XXX public that conduct you RDAC September do. the this

on submission Gerry slightly is efficiently having plan, running details after of will original and that study the best share is decided up Although this allowing. shortly. later timing you program more successful the RDAC approach the than given we the with a timing this IND IND our to And our to getting and

Andrew alliance manufacturing, to we more as and the alliance transformative today maximize have to the exercised the to very commercial that history EDIT-XXX a the exercised It enhance opportunity EDIT-XXX details patients. to and meaningfully We early as formed and XX innovator is capabilities on the program medicine year. Medical Concurrently to strategic further option the detail bring our of over globally their share and would are LCAXX part commercialize Officer, last turn its pleased Allergan we to has call we to announce close development develop since call. option in RDAC this will United as States. our later deep provide and Chief the in long development, has losses years. history Cox to and and very for program the And study. with Gerry on this profits share and ophthalmology co-develop well I as natural that, an to Allergan like our over the established

Gerry Cox

Thanks, Katrine.

editing and true the First, gene CasX protocol vector. experience on This the in and gene trial clinic. NIH the protein may at RDAC. the committee Director involves a The an advises guide-RNA is the to Institutional from The give discussions. by product In delivered it on color the encoding the the vector. currently Board when and having more human gene EDIT-XXX, the so transfer the of Biosafety are RDAC by because that NIH bit the of investigational case product or a recombinant that that of EDIT-XXX clinical several meet requested the Staphylococcus molecule viral the reviewed substantial a is aureus Committee candidates federal of delivered DNA purview RDAC has NIH under Review in novelty advisory benefit is certain discretion recombinant Institutional convened is falls DNA AAV the criteria.

as trial site made has clinical request. is Massachusetts Our such design here anticipated first

course review long not we be it that as RDAC. noted transfer Of in and possible to their gene ago her asked protocol NIH of guidelines the present human will is the Katrine for not to revised comments,

and available If and RDAC expect that We scheduled their we is via to the approach processes public have review a respect be this deem open meeting will they will and whichever webcast. appropriate. most a for deep regard NIH live the oversight

advancing study In addition our we're LCAXX. the of RDAC for history natural

prospectively interventional and As design for a aims enrollment study evaluate patients inform to to reminder, facilitate this trial. trial

trial. natural Germany. patients five have study patients we the sites completion one get study interventional our and including first natural history in the We history study, ramp not to as in to now we in does enrolling its in four continue up U.S. However, into human the in Phase X/X and plan evaluate

Europe add data more by of two in the the plan of year and sites to share next end half from first expect year. We the study initial in to the

to over Scientific the to I'll our discuss turn Now pipeline Charlie call Chief our Albright. Officer, progress

Charlie Albright

Gerry. Thanks

on As that we tolerability At study we or for & approach EDIT-XXX we found that Therapy, the of IND of filing EDIT-XXX either data Furthermore, Gene our most for me American panel induced EDIT-XXX, preexisting set was of for for as and or immunogenicity that let medicine impacted the LCAXX. or submission. a clinical some Society Meeting study in data pharmacology, either based Staphylococcus primates. specificity, In primates. in AAV an in a date comprehensive CasX experimental immunity Cell duration a ASGCT editing EDIT-XXX presented tolerated these over and the To well nonhuman recent test. gives nonhuman strong confidence pilot tolerability review supports productive immunogenicity nor us data the the to of study substantial aureus

collaborators cell from EDIT-XXX Eye data which USHXA human our cells our ASGCT benefit gene USHXA receptors, the type XA next both USHXA lacks mice our retinal disease for cilia showed such cochlear the Massachusetts knockout from Ear. we vitro are with Meeting normally in will presented in of that the Beyond successfully inherited formation EDIT-XXX These patients. in cultured LCAXX program exon advancing at Since USHXA We XX cilia. deletion product in data rescue experience. and Usher affect and Syndrome

relationship medicines of associated making done Celgene to the targets currently year. papilloma toxicology for models cancer. medicine We expect T-cell engineered fully and lead therapeutic other route to tumors. in gRNA and solid USHXA AV with delivery, The same pharmacology gears is promoters look revised collaboration major experiental sharing with more the of the the steady the was more Switching and This engineered type developed cell balance lead in the stereo The develop EDIT-XXX. we forward human collaboration virus to focus will programs program the we quarter on expression use progress for we our enable CasX is medicines, over program optimization. for to and USHXA second our that revision

we more and in under second forward targets in hemoglobin expression look we the hemoglobin in others over Hack native of to be in durably a the sites This effective the enhancer. strategy this comparison later targeting program the BCLXXA levels contrast, medicines of Based summary, erythroid very erythroid and of these vitro financial plan generic building our medicine results. our business include higher on hemoglobin data thalassemia, will that repopulate other data quarter are a continue are with In Officer, we on sickle discovery blood pleased novel half discuss induce cell call data to from a medicine these busy disease data locus, gene. system. our development to results that Chief Andrew Additionally, the progress inducing our the With the enhancer to novel sites toward to we will develop we the We to that a the fetal progress I'll that, the pipeline for to our ASGCT safer beta-globin turn at presented targeting year. can robustly drive vivo the in editing and beta second review in superior forward and Financial this are year than present for to opportunites. working currently BCLXXA demonstrating to

Andrew Hack

pleasure update you on and my to the reported financial we're to business today. results It's how Charlie. summarize we that Thanks building our

we the EDIT-XXX has announce for financial earlier, in ratified to well developing We XX-XX mentioned LCAXX. the U.S. Concurrently development today to responsibility commercialization in that United and the its exercised EDIT-XXX in operational globally. its partnership excited us join exercised that for to development taken has Allergan to our as option they U.S. for as of States. have for Katrine EDIT-XXX option a decided that outside As the EDIT-XXX and we're Allergan

recorded from $XX of application million exercise As have which another eligible we received the be to Allergan IND in acceptance third Allergan for the fee upon a decision this from result receive will a We're million $XX option quarter. EDIT-XXX. of

development Allergan profits the Going from forward Editas EDIT-XXX U.S. all losses the will of and commercialization in share and and

our of million addition, hour XXXX. which decrease the milestones single-digit a well securities of will are $XXX as capitalized I'll million cash, as summarized issued remain commercial financials for of receive well XX, XXXX March cash ago. roughly an in to U.S. with the regulatory as XXXX, turn In quarter from June release second marketable we and $XX and equivalents Editas now press outside high activities very XX, We royalties

Capital As the million expansion received million quarter $XX above, quarter expenditures from quarter we Allergan. cash not $XX received $X were the recent cash the and approximately in the related them. which used in million. Celgene in balance this recently includes our Net second mentioned operations agreement from million, include does I $XX with of to totaled

value sponsored confident success-based that for depreciation. in with expenses will income million given as important Therapeutics Moving to settled to advance recognized our to our items recorded in sublicense non-cash platform inflection we statement, as our at remain in of least with the stock-based platform $X development months cash license We million $XX.X million and position Research related success our million of revenue that $X.X payments and compensation, related payments in business of we $XX.X believe $XX.X our and $X.X and of XX to collaboration fundamentals well statement with us funding points. million million through development the and process Celgene. current and and our series million a Key of equity $X.X pipeline $X.X $X.X of of expenses. consisting million million were trends included research Beam of of and agreement provide in income include

turn call me for comments. let to Now, the back closing Katrine

Katrine Bosley

Andrew. Thanks

I'd executing Before we and our back close long-term progress our it, our like EMXX and short-term summarize against both step goals. to objectives in

filing on is the are EDIT-XXX be IND vivo which human we the clinical trial. to in poised First, the for to verge first enter CRISPR medicine of

with additional solid Sickle experimental tumors. Second, associated for Disease ocular advanced Cell HSV and medicines HPV USHXA ocular and cell engineered

it Allergan. to IX and our Pharmaceuticals. the important Third, from the Fifth, we our added of continue decision through guide with collaboration plans be expansion RNA development Fourth, with active capabilities acquisition under to co-develop business over finally, organization engineering Celgene scaling up to thank standing we've adding for manufacturing we're opting of assets EDIT-XXX you leaders and and our I'd open successfully support your to to to today. interest building with that employees of and and Operator? Board industry organization and Q&A. our like Directors XXX our to let's

Operator

Instructions] [Operator with question first from Kasimov Our JPMorgan. comes Cory

Your line is now open.

Cory Kasimov

I'm guess, have any afternoon or guys, questions. recent good your bigger CRISPR I impact general you. for Hey, making curious these on publications the of whether your is the safety followup clinic I two approach had picture, I technology? just for thanks guess my field after have get towards controversies the to them on with first in thoughts I've taking you're one got And one and progress the just then that. your

Katrine Bosley

a of Sure, ask to think thanks that's something Vic? the to for a Officer specificities to us lot Chief the Myer, and about thinking follow and Technology as Vic time that closely spent who of others on our I attention, of company. garnered lot actually question. like Certainly, since because I'd founding very know this we've speak working you

Vic Myer

these a were medicines. recent level Presumably gotten specifically in dividing at Cory, about this saw of process and Bradley a deletions, we think and problematic large cut actively a when around the and have part ophthalmology is cells an site unexpectedly of thanks. narrow they Yes, lot Bradley looks reason think actively you make repair our and very of the to or important more called directly I that's press, at don’t from This talk likely from thinking the along cells [ph]. observations and events. site in work ultimately resection. more of about is we directed paper the result the the if are versions pathway been cut it's Lab an repair based on you point. generally events dividing all broadly publications the considered has a are natural the CRISPR looking look so paper These are of unexpected saw vast insertions field and The low investigators are majority site this the they talking the window

on are in is are So pathway they maybe Editas, photoreceptors because this not impact this not cells. what differentiated, active we likely at doesn’t are research to is doing the method finding to here LCAXX certainly these dividing first

only Second [indiscernible] inversions, cut larger deletions at to the insertions methods multiple translocation. piece deletions not look is small more much strategies using around at also but we've always and embraced and the site broadly

So we've of interest a safety we've we've shared all of risk any tissue preclinical programs some experiments to outcomes a analysis finally have that the of data we externally. been time for ahead looking of package type lot quite And molecular for our for we medicine. and look this of developed genome, are now type cell but and the course alterations reduce these the the or also of experimental to for phenotypical analysis any clinical novel of molecular with in couple deep

Cory Kasimov

is stage at a wrapping and for your one, back that's meeting to novelty my gating of your the logistics the Okay, there Thanks. meeting why question want work about this precedent that be given is still program, has potential and to I'm ask there center then wouldn't the subsequent up? or case is very a there helpful. guess meeting. this only I you're up RDAC reason go potential factor wondering and other in any any second RDAC RDAC is that or to this And a the the and requested first – there I follow is of IND

Katrine Bosley

publicly We're a that Gerry bit is as comments and mentioned how One of in why RDAC so that mentioned thing it call ago should that a precedent next do if publicly, that. to they the haven’t that's interest win. now about we'll and half event perhaps and will they choose a meetings certainly review had this in that the in comfortable do let his Gerry if occur And to if going the sort year to or review folks or so that week is is public we and in not. know and many worked a changed there be harder if they or as don’t this and is

So across everything work. obviously gating, well. so some Basically to stay finalize it we're tuned, staying resilience in there's we're two of the in continuing strictly as these tuned work towards streams parallel not is the IND

which underway finishing actively So it's cetera, et reports, finalizing finishing nuts full is of that here. the a we IND are they and all documentation, are bolts

Cory Kasimov

it you good Okay, with questions. taking luck too the for and thank

Katrine Bosley

Thank you.

Operator

Matthew our comes you. from next Morgan Thank with Harrison And question Stanley.

now is open. line Your

Matthew Harrison

I taking the Sorry, question. thanks was for on mute,

from me two as think I well.

So how given as regarding Cory's RDAC, mean if on choose followup And meaningfulness precedence then RDAC first or just you EDIT-XXX question, I it's whether part of meeting? the a changed the a one in of review have the followup to a of could I have I publicly lack they do the on then. view not

Katrine Bosley

of back that, will submitted number end this meaningfulness interpret process. we refer data Yes, that's to day them, a ways think I – a think probably have the the I part is we to but package at of to of to

Eye submitted a RDAC Ear Massachusetts committees looked to it. the to – and they a they've sent the have package at requested request our to review data, the RDAC. So then We data

So information amount It's they're a quite – substantial of fairly about of not a receiving it's just this data. bit program.

and say, of XX-odd-years. is for evolution been they how and evolutionary review about fit in hey a over of field a decade – first lot public into this thinking technology think the their medicine. review they vivo judgment in idea. seen it, consciously Board, way around there's need think the just like that it's an then may and the questions or not layer if this, if I'm so And feeling to to I go be all think for to appropriate they will don’t they choose FDA, Institutional I the Review are they've gene a may IBC choose remember good medicine covered the they the and They've is CRISPR editing a additional between really really Otherwise

Matthew Harrison

could around I any the second meeting you've extent thank perfect I with FDA, then you. engaged just about agency specific? that if broad broadly with you the Thanks. or wonder you that concerns guess pre-IND that's CRISPR to IND around question the helpful, are filings most concerns just are not think whether comment product medicines the And of there is or Okay, agency in

Katrine Bosley

a have been we at in various the date. them. and we've editing heard editing of been Gene they've hear what INDs number know Editas we've to with of they and publicly themselves say anything consistent to date from we haven't by is number a at and has Gene meetings been commentary what INDs think allowed FDA surprised them and from that You engages public at that I reviewed Certainly

packages together. our comfortable I think we're coming that data

Operator

our with And comes you. from Thank question next Peter Lawson SunTrust.

Your open. now line is

Peter Lawson

on Hey layer Katrine, delay internal the for the filings, RDAC that products? there were just modest caused on the mostly IND any has Committee potential or

Katrine Bosley

piece all the really different imagine to Yes, while them it’s there emerges the opportunity can this Allergan data you us feedback is at together of bring very and these pieces incorporated. together. whole trends Also that’s the is meeting with been as that for and then looking and also every RDAC of from course just give how stick we’re looking time these that at potential with opting in if operationally close all

bit it's a really call anything. a than more of logistical just So

certainly after that as rapidly to patient as first make going that work to treating possible IND We’re as allowance. do - continued position to a the we're work towards to sure we in

Peter Lawson

expansion then And that program? just you collaboration the Okay, Celgene the thank think we'll see of [ph] the do around you. color first on when Juno

Katrine Bosley

this to this from program, his data in more that for be mentioned later year. Charlie we look as year that later expect So, comments, sharing so

Peter Lawson

much. thanks taking the so for All right, questions. Thanks okay

Operator

Thank from with comes Barclays. you. Gena our And next Wang question

open. now is line Your

Gena Wang

the so be the Thank a for two asking filing my questions filing the IND questions. about independent two and just also meeting? meeting October you of and if the in first bit and help with IND RDAC will for understanding expect slightly what one little RDAC timing, IND meeting process, you after us the everyone, to RDAC, just you RDAC taking you have said I prepare share can from you would learn to wondering wondering a the my for

Katrine Bosley

processes roughly them to they independent right, one as. run as always parallel so we another and Yes, with we are you're in said expected

like for date advance the and You RDAC to the kind That us the meetings filed is look in meeting. in things the consent a data September they think deadline focus September package one particular if eligible our they RDAC July. you focus at bio for that what we package to at and do informed that. of about, that safety be file whole have that’s but the late made scheduled on was look RDAC and And like the sense they for reviewed things the why

think dates anything. prudent as one the fall just that we it, ourselves as with the I another insights given may avail from to to And any come just respect it of that as way at so, look is pragmatic much seemed

Gena Wang

hold, extra there you careful what or to are filing? to data so avoid extra IND question IND hold the just to sets clinical on a recently IND just anything that with Okay, any few be related is wondering the preparation potential anything prepare just - delay wanted

Katrine Bosley

I’ll ask Charlie, our CSO to speak to that.

Charlie Albright

We other we're thorough set a people's have obviously based many have do comment but we to interactions what regulatory, for been what planning upon. confident with and about we don't data package feel months that's the that on we on holds were cannot clinical on based know acting our been preparing assembling anything and

Gena Wang

other the last differentiation wondering there same can companies approach Okay, Program, just beta with Cell or for approach, versus few and highlight are thalassemia editing also technology, I others? exactly differentiate a as if one know not you Sickle question approach your Gene

Charlie Albright

are locus meeting several globin because that's they're by knock We've are hemoglobin but not instead more also that approach a us, and the pursuing being a of competitors that And screen locus human because on the is beta ASGCT Sure, more in and genomic BCLXXA meeting discuss approaching region hemoglobinopathies broad region erythroid general started tolerated. targeting screen on upregulate December. focus the the that fetal to the sites the We for enhancer partly of genetics data at decided within gene the out data. gene in the we've that where the directly. based discussed there is some comprehensive data enhancer that's approaches the upcoming of BCLXXA allow upstream promoter that's to of and partly Lente gene that at will of our beta editing our the and ASH vivo pursued points are we'll us targeting lies including viral the that and

Gena Wang

Okay, you. great thank

Operator

from Capital Thank Amusa Chardan Markets. with comes you. [Operator Instructions] Gbola Our next question

now is open. line Your

Gbola Amusa

at it’s for Amusa Thanks Hi, Gbola Chardan. call. my taking

Just be a what what mutation ASH, update present be so on that couple for of have therapeutic do questions then in for the Syndrome, might helpful specifics Do far. I have at super on LCAXX? on was example editing And a on you you estimates you there October? the any Usher thresholds similar might to those ASGCT had

Katrine Bosley

Charlie will capture those.

Charlie Albright

start editing in on so we our studies of same that generalized do setting for for therapeutic let were target humans expect to So based with targets level rationale the were me LCAXX the because [indiscernible]. USHXA,

one running them to the as we disease multiple logic expect target a inherited well and be by highlight will we improving same those for in be programs my will so advantages learnings course And one about apply and that related so vision areas take I the the LCAXX talk. the we similarities to can others program. XX% that retinal At patients' some will that ASGCT have So area photoreceptors and talking of from these on in programs. that's the of of dramatic effect ability of

Gbola Amusa

thank Right, you.

Operator

you. question Cowen from comes [indiscernible] Joseph next Thank our and And with company.

Your open. now line is

Unidentified Analyst

taking for questions. you thank my there Hi and

natural initial the decisions I either is the a the sort the know primates going history of packet materials can half a saw nonhuman sort it of went patient of triggered first on preclinical or clinical get something patients XXXX, decision? was the simply of NIH timeline X the opt-in, the Phase or and Allergan in that you And data one IND we're first more through interest the RDAC going the Allergan from of but of as The is anticipating study meeting in of experience? then or the submission into that the the second, there sort data to you are subset in guide

Katrine Bosley

So how the I’ll ask worked Andrew to to the Allergan in opt-in relationship. speak

Andrew Hack

question. hey Yes, for the Sure. thanks

in So the various program. timing of is opt the the by in Allergan events driven

triggers opt-in ongoing haven't basis information well to point the access at aware to result discretion they program relationship, what their that We they it's purely time fully in the to and opt-in. I a They this decision. everything substantial do disclosed on of not respect that's opt-in for of any they the an are and but so have made program going absolutely were their as the with think when made informed on in

Katrine Bosley

And speak history Gerry to natural I'll ask study question? to your

Gerald Cox

Katrine. thanks Sure,

will and how we We that X/X X/X and design risks, the to of bit are design enroll patients children [indiscernible] perform those us the certain Phase factor the then helping may assessments and that the able the of thinking formed as all those study learning things and patients. well a natural into adults about of be are the history benefits in what really and ages Phase study from includes part that feasibility of

Unidentified Analyst

you. Great, thank

Operator

Q&A closing call I Katrine to remarks. concludes Bosley Thank turn the you. This today's back for over session. now to like would

Katrine Bosley

thank you. Great,

to all as in bring And of your the patients. new today’s so to with you that I'd like medicines thank work we call support and for transformative for to participating

great So, have again Bye. a thanks evening. and

Operator

This thank in gentlemen, conclude and Ladies does today's you participating for the program. conference.

great may You Everyone day. all disconnect. have a

Editas Medicine (EDIT) 6 Aug 182018 Q2 Earnings call transcript