RGNX - Earnings call transcript Q2 2020

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Operator

Good afternoon and welcome to the REGENXBIO Second Quarter 2020 Earnings Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time.

As a reminder, this conference call is being recorded. I would now like to turn the call over to Mr. Officer Legal Chief Christmas, for REGENXBIO. Patrick

begin. may You

Patrick Christmas

and the this us Good are financial financial us and afternoon, Officer; www.regenxbio.com. Steve Medical on conference as outlook on risks call available XXXX, not for to file website undertake joining on with quarterly These product Discussion results of guarantees Chief other webcast. information, or and may other expect, account our any XX, second is and may involve the date and for operating full X, and call, risks press call The are will intend of include afternoon we we on to Analysis thank Today's you XX-Q will, released conference of XX, believe, provided Please at website. advised forward-looking Dr. Officer; from the Chief call our should, certain update and XXXX. of plans. today. are and Pakola, performance uncertainties and Form Vasista, no June recorded is statements future is development forward-looking year Ken report in only call August on anticipate, information be Executive words statements available regarding SEC's ended XXXX. as of make financial REGENXBIO this described XX-K our this actual forward-looking in release plan, to Financial of REGENXBIO's filings, business Earlier ended Any be today's Exchange With subject Chief obligation that which cause forward-looking Risk provide and events are the Factors for Vit regulatory, being addition Mills, the results results differ And and and we otherwise. on are such the and that REGENXBIO's those annual may, on of statements President uncertainties. this Officer. and sections quarter and REGENXBIO's reporting the new meaning. our risks Commission forecasted to statements words Any similar and future such sections These can comparable December identified report and other on Form Securities Management's by our

unaudited is I company. In over call not Mills, the President to Officer preliminary provided forma purport or addition, and that project positions Ken? be any like differ may financial or information would and Ken the REGENXBIO. results turn may does pro results to Chief materially. operating Executive to now financial of Actual of

Ken Mills

time and Thank you, joining week. for Patrick. Good afternoon, a us second this for everyone, thanks

now progress, gene we and Some updates Steve of safe from us advancing recent for development results I'm and promising the We're our provide will updates pipeline programs for of gene broaden challenging evaluating our pipeline the to REGENXBIO, questions than pandemic. clinical have important call the COVID-XX hope course, today halfway in second XXXX. that decisions prioritizing backdrop on report well Rockville, our made the therapy update strides of Vit financial On is will of that year, in data. here of today's as we therapies, is well. conference live pleased a our RGX-XXX our us on provide candidates. few about quarter and We've latest little clinical an key offices allowed for a despite are updating while and Maryland, and everyone and and has our XXXX including programs, productive very that more been to through

our with treatment share was RGX-XXX an led on a retinal held AMD. Steve by for earlier mentioned of the several the update program I conference to As we leading that and this specialists week, of call wet

to demonstrated of long-term call improved injection you as this X/Xa compelling provided patients. Cohort in retinal already gene of if out data with two have study we years, all a RGX-XXX broad so. clinical X of you evidence Phase data reported us therapy. that Cohorts visual year. has in to done in us study from from of and a of stable April, Patients also one potential gives we range to So from X, and reduction meaningful which to this out haven't to X durability in I in AMD as our of profile The acuity listen invite as confidence the wet treatment well for the anti-VEGF have X, thickness, burden And

We use and this will program, details design first-in-human the initiate of of the AMD. and half Microinjector forward which we the SCS in to the the those XXXX. of We second known Phase further inform the of to by patient to to earlier week, study data expect interim data study the X year. pivotal in weeks AAVIATE this We this the controlled our using coming providing announced suprachoroidal wet in from the end the months this our RGX-XXX first had from cohort treatment look come. for learnings delivery advanced patient Also trial randomized planted as in the expect in for our of first we

X cause the of affecting a States. leading suprachoroidal use diabetic of to loss, in people for delivery treatment plan route retinopathy, which the the approximately million vision is United also We

will to and and half expected with initiate reported in on progress we programs. these the second related expected genetic of Phase July, now clinical X of update interim milestones on status to for in update expect Steve? current trial an data the programs We XXXX, In diseases, XXXX. Steve the a rare

Steve Pakola

Ken. Thanks,

events. dosed our reported in adverse serious of levels patients Phase second drug dose treatment As in three completed we were X/X and previously These patients MPS intracisternally well the RGX-XXX announced, patients of be the no across cohort have of was study to for RGX-XXX tolerated II. dosing with related two of

study, both year. later to additional program data expect as the update provide as We this cohorts a in from well

under program of we month, provide to Phase MPS our of reported a by investigator XX who At a sulfate of intracisternally IDUA enzyme patient data clinical expect update a was from for Last severe for as week the cerebrospinal RGX-XXX treatment trial dosed as the in XXXX. a in I X/X CHOC at the administration Children's. activity increase patient well after decrease RGX-XXX, heparan was also with MPS detected, I initiated We end single an of in sustained fluid. IND

patient the In to evaluations week at that normal skills acquire neurocognitive rate XX. addition, indicated a developmental cognitive at continued

for are We very by study. this encouraged and biochemical indicators clinical the

drive patients, and evaluating of single for team. further of continuously to portfolio candidates the expertise administration leveraging committed are We our to our gene therapy innovation

disease. been some We of manifestations RGX-XXX our treatment have known time the working CNS also for on the program CLNX as Batten of for

of durable with the address new the we this the We program for we unmet in in treatment upon As understanding potentially administration are peptidase deliver ocular of of to vector gene know and of therapies RGX-XXX and XXXX RGX-XXX provide source activity to is the the RGX-XXX many for to our half struck the decline. CLNX. of closely gotten gene thereby and bringing a manifestations enrollment patients need of families, to program, the we the X first submit work of to disease. preventing community the second retina directly use forward TPPX manifestations the the initiate tremendous We by one-time a TPPX designed of in of retina. IND visual or for plan tripeptidyl were believe half to could AAVX an XXXX. Building eye, in therapy ocular

This We reflects opened RGX-XXX the collaborations CLNX which expansion the also the have to also two forward. CLNX our understand of natural to through commitment program, continues studies history and move established and patient build community, disease. to non-interventional better relationships we'll ocular manifestations the upon

that, first turn IND We in by half this expect enrollment the year With a X/X initiate end an it for over of in of XXXX. Ken. trial Phase to and back file RGX-XXX to I'll the

Ken Mills

you, These encouraging Thank are Steve. updates.

discontinue the stage or programs Familial gene grateful development of one additionally, over today support difficult of the the community we're announcing therapy patient was of to that years. our and a the treatment we've Now, internal we're HoFH RGX-XXXfor clinical Homozygous first of decision RGX-XXX HoFH. Hypercholesterolemia for made

program since acknowledge supported cholesterol signs the these of product the work options that LDL in profile However, therapy dramatically activity therapies of emergence lower pharmacology we're several has approach began of shift target new The treatment seeing at gene the populations. landscape we is the with our level, changed, we biological dose needed. that while so second further

where turn and Vit inhibition HAE, data preclinical of will AAVIATE plans edema half AAVIATE. our program continued future. the I We activity also benefits With in of of wrap our for through to business focus call potential like to treatments details comparable to to has opportunities biological And neuromuscular progress foster our other plans will certainly the anti-kallikrein data around the cooperation that, more through this inflammatory to kallikrein an the up, treatment in have with and model we announce to for that treatment and development, the on our share financials. disorder include in demonstrated scientific discovery for investigators trial using patients of of for clinical animal on advancement second and ways the just over now to look based review support XXXX

Vit Vasista

headcount, XX, million cash million milestone attributable three trials related XXXX. result laboratory in candidates, the recognized totaling compared of the equivalents and the upon Research Ken. and cumulative expenses three preclinical, increased to billion increase manufacturing-related XXXX. to million $XX.X $X.XX million million costs, or quarter XXXX. cash, sales of personal REGENXBIO result royalty payment net for expenses development and months used General a $XXX the other was million million and as for REGENXBIO the XXXX ended and of count three since the launch was costs ended $XX cash primarily million. share our net same Net basic activities. December was $XX June primarily a sales professional in are on costs $XXX XX, loss achievement diluted million associated XX, compared personal in XX, The June basic $XX.X to increased May, period is second in XXXX $X.X ended of conducting and to XXXX. the for $XX.X the net attributable Revenues related The ended as decrease same and XX, million compared for were greater of of of primarily for million compared Zolgensma. June net period a was XX, of same for sales $XX.X product quarter to operating with increase for period administrative were net XXXX. XXXX, XXXX. eligible externally increase or was three lead sourced primarily net Thank for expenses receive share and diluted June for loss as period Zolgensma you, than attributable of attributable revenue loss services million in on facilities clinical $X.XX in Total XXXX XXXX for activities securities were per of and million months a in $XX.X loss advisory same to and months months in The for of head to fees Zolgensma and to services. to the in ended with million to the $X the $XX.X $XX.X $X.X marketable XXXX $XXX.X June per regulatory increase compared net The

of had internal I approximately XX, of and balance on advancements operating clinical common will the of bio current and product equivalents Kenobi, outstanding. manufacturing call our expects completion As force its marketable cash, that, its into its we REGENXBIO With million may with to the cash you. candidates fund in the back XXXX. Based XX.X plan, to turn be Obi-Ken shares capabilities June securities

Ken Mills

Okay, Vit.

has gene pipeline an the technology progress Novartis’s platform Vectors of clinical from from development. demonstrate milestones others own late product gene extensive proprietary that several our pipeline. therapy, many aside achievements Zolgensma come NAV a stage And partnered As as in and the a REGENXBIO internal therapy. one-time candidates, internal and as our including provide of one are in from can our NAV marketed we've additional The partners, in further footprint validation and transformational mentioned to basis impact administration before, our our product well extraordinary

We're the pandemic. business the milestone. expansion of company Novartis see more includes strides of also cited, expanding positive Now which the On curative making recent And momentum continuing States a the U.S. initiating gene track despite uses to forward, our the grateful COVID-XX, for with COVID-XX AAVX as progress like continue towards United we to challenging steadfast for its and on remain therapies. to great further our this and of the It's the we'd this cusp newborn at gene questions. with talented Japan, regulatory be geographic be Vit single-administration to call global focus employees end through today. launch screening we'll potential to progress We're and of of dedicated despite and I than the therapies, robust a this effort growth uptake conditional and exciting to that by backdrop month portion lives, formulation trial therapy, since open pivotal of vector. first outside of its in of drive pipeline Zolgensma additional and earnings the have the of that Operator? up proud after mentioned, forward by driven strong the RGX-XXX, this the in pleased market. And for approval we I'm positive the the potential developments the call on with improving quarter business first in and a broad experiencing our dedicated the of who that, to to the to remarkable Europe in our encouraged for truly We look continue momentum and therapy. intravenous decade mission.

Operator

our Thank with go you. And question Barclays. [Operator from Instructions] Gena Wang ahead. Please first comes

Gena Wang

you for taking questions. my questions. two I have Thank

X First XXX, one trial is regarding suprachoroidal the design. Phase

Can dose first it retreatment compared And programs. color that eye? the the cover this give back can little you two CLNX also for the subretinal the criteria decide of thought you about CMS? overlap space the my selection? how would the And patient versus the broader injections the on First, symptom how two onset bit second you the for more for so a And doses – be have procedure? of how's using regarding patients? is to ocular us could question the And then much for regarding

Ken Mills

Hi, great Thank you’re Steve, I'm Gena. – questions. you. This yes, are is Those Ken. to going on.

Steve Pakola

Hi, Gena.

Okay. All right, great.

of COVID. You of different spots realities see the in times being in

Gena, So questions. those good thanks, Yes. for

experience Clearside that's at SCS XXX suprachoroidal, is per GCS first number specific And from eye this with XXX So using suprachoroidal going of device be our delivery the looking Microinjector with within cohort microliters. the where dose to existing is microliters. high

study. to we get highest that So that to dose were able in the subretinal

globe that raised a suprachoroidal you the with delivery, a point with injection data So given XXX preclinical with covered good suprachoroidal injection. the one that get even suggests a you or surface about microliter half of the retinal

single that on going of of do in but entire that what the injection, there. up off possibility to cohort cover early to side So of single microliters. a in for bat exactly it the that microliters, second the that was suprachoroidal microliters days and the step have other XXX a to the raising, two thought decided you're dose going step the XXX we XXX with degrees been second terms potential best microliters use right we surface. retinal eye a first X.XEXX In dosed But XXX could at, injection. to the are right have that example, has been the GC XX also dose looking take quickest and a get eyes over a have from a same in device injections learnings, XXX to give concentration by separate microliters way learned Clearside a earliest the using and much the leveraging We while with to or start how been to X,XXX consider

And into of And do great when a subretinal segwayed side systemic and CLNX patients relative which disease. RGX-XXX deterioration now you hearing the patients. the the that side of much going but question newest neurologic course need really need systemic the these we're living as the that it's now big a in the now longer, ERT terms RGX-XXX our to is a how where from disease. that ocular ocular of question second in time see and are realize families for Your the us for really beyond program is unmet suprachoroidal the that treatment, blind. to disease allowed interestingly it's repeatedly addressing what unmet of given big exists, They're complications the

So proof our with for experience sense also very especially, retinal in real now, become to this we validation of where us concept our has area, makes for vectors, a direction. and have it clear where for us and this delivery, go

where evaluate that there's the it there than in you to how course course the treatment of we're manifestations. of type gene a likely have gather you ocular is CLNX to time thing an development history the If decide of manifestations evaluate a to imaging is course, studies see history the disease to help even non-ocular whether us more terms involves time of announced the out right terms power is enough natural natural we're impact even but later to having groups enroll, think of the information initially to the it non-interventional as patients natural what's have And evolve, patients. evolution to be going the in going where one-time the two little early in starting age on and of by therapy actually we

Gena Wang

Okay.

about for criteria subretinal? suprachoroidal the rescue Just injection the comparison to – like what

Steve Pakola

thank accidentally Yes, over one. skipped Yes. I you. that

patients as occur. the study retreatment, for So often had and terms so many how might in talked in our we've against us a which we stack that very first-in-human reinjections deck about, bar low of

bar some traditional that can of that concept you had we that start feel range see of a and have to we retreatment criteria. with higher studies more in to in very albeit the effect doses, solid have beneficial a clear subretinal actual later bar across other we're delivery, of that position moving stage proof a Now of evidence

good a that's point. So

from right Phase already be our studies start traditional the SCS criteria. more wet per AMD, of kind we'll We’re a suprachoroidal X/X using with retreatment

Ken Mills

Thanks, Gena.

Hello? operator. question, Next

Operator

question America. with Please Geoff go ahead. next Our Bank of Meacham from comes

Alec Stranahan

this taking guys, Thanks our Hey for is Jeff. for Alec questions. on

First the transaminases the efficacy evolution of on your a around And discontinue on XXX, to the the decision? delivery the the case landscape, understand help the provide speak or could how also XXX be bit you development inform inform side on but more guess on decision you program? then something And elevation CLNX would I Thanks. could the competitive in retina us of some work of nuances the more TPPX that could helped for versus you intracisternally to the color XXX, the of great. did XXX? programs, if preclinical also to

Ken Mills

Alec. Steve, off Sure, I'll here start maybe jump needed. you and in can as

Steve Pakola

Right.

Ken Mills

really to data XXX, we bring bring certainly the with the to to more that the respect described, several understanding, when are through the I to findings forward forward with the I mentioned, had changed. when we've that respect expect all in trial – development years that with different There the have as of ago. we investigators initiated of think been a which the we is that enrolled science have saw coming treatments date. to Alec than this what status certainly chance was I has With what work patients of and landscape us,

could lowering it some cholesterol steroid some which definitely saw with level the of Some the protocol. dose too as effects felt with are target and And we has we the early prophylactic elevations treat manifestations having and raised product lowering for as these well of examples profile while the effects, significant we bar of transaminases our changed risk benefit. clinically lipid and

levels I even the patients naturally, are things steroid patients. in think also that healthy we've elevate in cholesterol acknowledged these protocols that

wrestled that to I that have work so data ability to additional investigators we'll them. so respect bring pharmacologically forward, we an at with. to to with data something Penn with with coming when do our it's And And we look think

therapy XXX the the was respect much it the absorbed of for it of XXX, but of additional I in and need really gene prevalent the it met therapy that an engagement approval the to need not was existing is And and we enzyme CNS ocular on the On the manifestations Batten CLNX the bit there Steve some a replacement alluded be Gena's so of in work be cerebroventricular disease. met the Steve patients in brought currently for either. on replacement the up going being and the alluded this the as wouldn't And more Hearing a may solution how for with expect received by conversation, question, to, wasn't therapy was XXX unmet that's answer treatment around to population think there waiting here, about as even with late preclinical by community a enzyme in therapy. would to approach evaluating – existing onset market, manifestations disease. intracisternal real,

preclinical and leverage And on to was idea the delivery occurring. where TPPX site investigators gene retinal pathology Luxturna. subretinal have of to the the – programs encodes like action, had cells, the of like call is deliver So where our with that disease understanding directly others to experiences our the in

addressing not we as that's is case, important all going of basis need And to multi-system the approach basically so probably severe these be CNS diseases. the quite intracisternal of to address for which for that vision treat for approach routes with unmet CLNX. therapy administration addressed in going unusual this in going can loss And view a this become the as is a on we a different intraocular to well to forward think manifestations, are gene be something

Alec Stranahan

Perfect. very on progress. you Thank much and congrats the

Ken Mills

Alec, again, in. question. dialing Thanks for Operator, next Sure.

Operator

Foroohar ahead. Please SVB. with Mani from comes question next Our go

Mani Foroohar

pipeline in strategic as Hey Vit. of equity control being the appropriate? terms guys, any them? strategically whenever assets first deprioritizing you do the view through how just think the Or and to bar gene evaluations expectations, you're cycle management bar? you and other for in as stakes for different another could guys financial opposed like is of something possible back the assets, pool high an for life around to think changing your going therapy one that's is quick of a When consider strategy have you for was? update looking Kenobi. are your stake indication and then which the how assets, I stage about you or reviewing equity, licensing you a couple the what in cash. assets going result to Like, asset Do the monetized standards the purely be for And of one other and different those early of do later transactions? see stages Apropos have prevail ones, still How

Ken Mills

Thanks. Mani. good today the you got Glad in you and why those don't bumped Vit, are questions. queue up one? take the first

Vit Vasista

for the alternative Mani, of We terms licensing the we get of we Thanks, basis. on cash do transaction wave general we normalize what them have as to Yes. would question. a equity when view company. if licensing funding companies assets capital continue incredibly in performed that we'll well take in you pools the just The and

So our use currently public of equity that's we stakes view companies. how in kind

Ken Mills

late to kind deep concept maturation and forward. this of to we happens an as a clinic, and well I are a stages something that to stage additional Mani. to And programs also advance contributions forward major into about strong stages of question. I first the subretinal but by we're have of a development, be through of a to pipeline, the advancing us think not think the the the the question our on in like we clinical established And decision development, us proof basis. identifying the something only about look, later important digging going landscape, for things a in as the we've is time basis I certainly is from example of things data, the including proof continuing readiness pivotal, concept outcomes program, managing RGX-XXX big funnel. something to from that foundation respect of making process awareness our applied of parallel next need. go commercial of with think in-clinic those advance what that on decisions the but to proof gets Operator, continued as for pre-commercial commercial have which portfolio, of and when Thanks, the obviously I programs And with the to concept do into contributor factors upstream obviously that It's mentioned, will of

Operator

comes Our go from with Please next ahead. question Gbola Chardan. Amusa

Sam Lee

Hi, Gbola. taking a this question and on have our for I of Thanks questions. Sam is a follow-up. behalf

RGX-XXXsitting First with middle? to a represent the for for the distinct completely inside circles would two populations each markets Venn in in RGX-XXX with the if regard intersecting to epidemiology, RGX-XXX diagram. and had some you diagram or Venn the targets product utility have that Is circle where represent in RGX-XXX would overlap

Vit Vasista

as I The well assessment with represents genetically emerge loss, ocular that has patients a math majority so and that system, Steve think phenotypically you're but alluded neurodegenerative, central Venn the thanks of sometimes – manifestations et for I'm vast a the disease, how guy both can terms and the of question. thinking to I like significant nervous component are of but about time. been a will as vision CLNX with that as there be shift frame diagram, overlap, analogy, in for that presentation, there's I think in cetera,

but population patients is well. eventually Ken, I therapy impact with all incident we start in going address or loss of manifestations especially prevalence existing and to, as maybe coming as first substantial So symptoms severe CNS alluded to obviously gene becomes to standard see a the in CNS care. as that the be vision

Steve Pakola

talking that are learnings bit going be community eye to a option aspect and patients these And the blinding the the patients patient I'd to done. develop. treatment that our a disease isn't for are quite of in for lack anything system and to in There these healthcare add helps where

approach these So patients some seen fashion. a of in these are very sent to feasible but actual with having a there's treatment, an timely

these be could therapy there forward, needy patients. a penetration comes potential So if a great for

Ken Mills

to Thanks for back the the queue. question. Operator? We're

Operator

question next Morgan Stanley. Matthew Harrison ahead. from Our go with Please comes

Connor McGuinness Meehan

us, steps thanks for MPS from do IND? Connor This guess those can you see you is data and the complete you to develop engage how for Matthew. the the then about what need quickly talk two want programs conversations II have Hi, before I just And and RGX-XXX taking you before you. I plan all you submitting to Also for extent just question. Thank do just regulators? what on to types with regarding to on

Ken Mills

color. Steve, and feel with this additional free Yes, I'll Connor. think Thanks, I I take guess

appreciate the CNS think, pipeline. I focus neurodegenerative on the the aspects and of

engaged CLNX MPS in of in history had conditions can and I We this II MPS as been we've the the for just with recently benefit as Steve because more sulfate MPS before the the gene MPS that degenerative examples interventions history part think I were these and have, understanding for early us and developed We system obviously we've of the the to I that enzyme of I impact consensus a but patients also among of natural pointed MPS much diseases between a biomarker severe care, by we've – have the have decisions of that II chosen, alluded have heparan with and significant. but experts driven around recently and like natural also therapy I neurological to as been II of, in to cases correlation occurring treatment MPS years about think said patients, Thanks therapy. the replacement now.

would what's very then natural but when agency get improvement even additional you lot an the from coming novo with to community. also a the have informed into so of understanding be this of de then profile, that addressing of talk program or rich the been able by that and and even history you unmet maybe think that, within people of with a conversations more a disease therapies And known within needs, gene an that beginning I because of

end by guidance With IND are to year. I think of is important our respect this we there. that's point of file RGX-XXX, an that So here the emphasis expecting to

it's the a vector, at of were about the we've talking about and have AAVX profile in with we're is I it when gone of that using assess through we the of RGX-XXX comfortable order of where months, sort proof opportunities we're stated dose respect decided type and which already to familiar CNS. guess obviously using. the work the August of lead something feel established and is typically really like something a based we're So on concept stage on we to and candidate

formulation things of expression we transgene approach that transduction evidence already different had So that product that were where types. with obviously in and and cell foundational and vector that

us would really of course, So we're work the administration. clinical guess We're to subretinal delivery the without ocular be approach. prepare for safety final steering remiss adding. now I that this readiness doing using and it around And would and

So we we're head from here. borrow miss into that that? experience anything well the also able Steve, to when did approved I clinic experience clinical as as on product

Steve Pakola

learner add. say the on done. nothing I'll as Well, just Plato Well here, to

Ken Mills

for the point. extending Good Thanks analogy.

Connor McGuinness Meehan

Understood. you. Thank

Ken Mills

Connor. Operator? Have Yes. good one. Thanks a

Operator

Luca Issi Please ahead. from Capital. Our next RBC go with comes question

Luca Issi

second trial RGX-XXX, conceptually is, trial? any Terrific. Thanks And the then differences recently on Roche quick from And that highlight? is IP that you'd Issi trial you. you Thank RBC. Should the there how study question. taking on similar here? assume like that Passage? Delivery think costs first my we dispute from that that trial the are for follow about how to System pivotal there question, updates Maybe are run? to should the on the are the Luca maybe Or design a that with trial then a Port thinking of about any to we as

Steve Pakola

part the take can the on the pass-off design I then and question of first Okay. question. latter RGX-XXX pivotal

and So the thanks, Port you pivotal so Luca. raised Archway the Delivery Yes, System design.

durability, approach that terms very by being repeated six similar being for different also delivery but able can that it's injections. you increasing months needing in every get somewhat dwelling that, – it So inject into it's of of paradigm in once down device. assuring the still It's is just to to in certainly

up design standpoint. winds aspect from very a important that being also So

to every months. I'd System being Delivery into six say, had consider re-injecting definitely Port they the aspect of the So

think In allow least differently to leading So visits for how about case, in and at decrease the majority could of patients option looking frequency is intended up re-injection. patients that be to they're the treatment other a our them at onetime injection. that this a of to

pivotal we'd but design So, you about. considerations, be thinking the type of can least say general think at I'd in sense, same a of

pivotal in that at even care, endpoint. population, beva wet the sense that whether, and it So to required makes considering AMD those standard non-inferiority. is of frequent with with a We we albeit routine active comparator know aside setting in differences a know look injections

Luca, like of similarities. lot a sounding this, So its

safety type duration general also also that of similarities you efficacy, patient Beyond size. based terms of and of might of the what on population and and other the follow-up in need

at there look So at. precedent people it's out least for a to

at our how and of the that, in we're We looked finalize aware are to study. rolled our certainly up pivotal we're but profile, our going sleeves particular we target design product our particular results of seeing that

Ken Mills

think on mean, of Passage, commercialization, actions is and received question. we'll will and especially intellectual to though to with companies where in are companies of been to stages interests view. of about with so future. stands. there's that shareholders be the is that be towards first of and our over infringement later I concerns We've respect this the We IP actions second That's question this those us with where and of be for they're in that near though be them focus saying nothing courses others a towards stage, the And updates that to heading Steve. on transition aware dispute that – infringing of in to of that time still later notified I development the important. are the a in are Luca, or at notified our Passage. Thanks, action of in it's first to the for IP our stages respect Yes. and on We've take this for development this IP while them now expect they've we've heading there commercialization. that's these our respect updating representing No preclinical or to their and with do obviously the update communication. taken on property will and of general, that companies it part

Operator

you. Thank At no this time, have further we questions.

call final the to Ken. back Turning for remarks

Ken Mills

thanks excited Appreciate you stays value of and data patients, our and And on days for the who operator. progress. and us spent that about everyone great shareholders. reviewing everyone night. the reviewing well joined course, the hope a opportunity partners, Thank for mission for today. REGENXBIO deliver two stays stakeholders, with have deliver appreciate and thanks We We us questions. you our those of Okay. that appreciate to interest. to safe, everyone. We Well, We're incredibly

Operator

for participating. this you. gentlemen, Ladies and Thank today's concludes Thank conference. you

now may disconnect. You

REGENXBIO (RGNX) 6 Aug 202020 Q2 Earnings call transcript