CLSD - Earnings call transcript Q4 2019 | Clearside Biomedical, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Clearside Biomedical Fourth Quarter 2019 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] As a reminder, today's program may be recorded.

I would now like to introduce your host for today's program Jenny Kobin, Investor Relations. ahead. go Please

Jenny Kobin

and call everyone for us joining Good thank the today. on afternoon you

begin, to constitute Litigation forward-looking XXXX. Before during would expectations, Private this I we like Securities company's the for we that make future be purposes call remarks the about today's and remind of will making statements Various Reform certain prospects Act statements. plans, we during forward-looking call, that you of

a result filings results Factors these Form as XXst, XXth, Actual on report XX-Q report differ and forward-looking those for including December those other materially section XX-K our year on the September annual Risk XXXX, our various by indicated of for available discussed website. may from our on the our the factors Form quarterly ended SEC XXXX, ended important statements in of quarter

our addition, views representing as views of statements today of as as forward-looking any In should upon our be date. any relied represent not and subsequent

elect forward-looking do so update may to our change. views While these if obligation the statements future, specifically any even we to we disclaim in

Lasezkay, Deignan, President Officer provide On Officer George our a provide summary. Medical will and Dr. Thomas our strategic Financial call and Ciulla, Chief Officer Chief will highlights; R&D provide our today's Chief a Charlie Executive update; financial will

for We questions. will open the your then call

would I to over now like to call turn George. the

George Lasezkay

you us the on joining and for Thank you, Good thank afternoon Jenny. call today.

order closely or resources platform. of our our with the to plans space August, SCS Board XIPERE, out-license to our worked our XXXX, to proprietary the and asset strategy. our to I lead dedicate develop company's In announced injection During suprachoroidal in we management team further reevaluate Directors overall to rights

as as SCS pipeline product research access strategic candidates. strategy the building enable to creating therapy novel well collaborations to includes as areas such proprietary deliver Our internal and other with to molecules and gene companies small two-pronged development an in their

R&D worked and Microinjector this we've objectives. collaborations will these Clearside in our tirelessly of one that strategic organization. the validating plan tremendously in They In entire proud using less two XXXX. to begin I'm year, embraced trials than accomplish clinical added SCS

for partnerships secured concluded develop a this further and begin We've XIPERE and later key Canada, also two year. the commercialize asset plan China. studies to to We've clinical Greater U.S., CLS-AX and preclinical trial in

Importantly, further eligible these R&D -- to these received on $XXX efforts. can we non-dilutive upfront as internal million as royalties and under that in are payments collaborations support over through our development future have receive net we potential sales sales used to payments milestone well be and funding

internal needs provide will an work the of look I to we team overview accomplished in address the now our unmet diseases. research has back-of-the-eye and development as

gene platform Our as are injection using as internal focused small prolonged deliver on therapy SCS to utilizing well nanoparticles. show duration may that initiatives DNA nonviral molecules the

our announced call which we injection submission completed are in earnings in we XXXX our proprietary refer preclinical on We of axitinib application As advancing are targeting as and work suprachoroidal we our for last suspension an CLS-AX. mid-XXXX. to IND of

using genes to work completed SCS preclinical utilizing so with delivery SCS therapeutic studies now studies We suprachoroidal marker nanoparticles. are of the DNA preclinical of administration further for potential have we also conducting proof-of-concept genes, transgenes. These delivery demonstrate deliver

additional Finally, our of small assets discover platform. value we assess variety versatile a to of and potential the continue maximize molecules future to

progress. Our collaboration partners are also making tremendous

in molecules and new partnering Microinjector. development both using small pipeline SCS validated retinopathy. our investment our It and choroidal including delivery our technology therapy begin suprachoroidal to decision to gene melanoma, and has overall also expanded our proprietary diabetic indications include wet Our has AMD,

of retinal therapy. gene field with treat leaders to to SCS non-surgical gene use deliver challenging virus gene AAV REGENXBIO, therapy through provide of to with industry suprachoroidal believe in one Last or Microinjector in-office therapy patients adeno-associated targeted that of the approach ophthalmic conditions. year, we initiated space potential can our a delivery potentially evaluate collaboration the our We

retinopathy discuss wet will SCS shortly, diabetic both Tom Microinjector. our this to REGENXBIO As using plans year initiate clinical and AMD trials in

area second where entered use deliver and our clinical in submit plans to unmet half of a a is there In IND ocular significant also Microinjector of collaboration drug Microinjector with Aura treatment XXXX, proprietary for using Aura into is medical this amendment SCS their the an cancers. potential we an Biosciences to the This trial a to our year. candidates need. SCS initiate

for on Microinjector deals Now delivery further partnering of and via very uveitis. macular an update we completed suprachoroidal proprietary standpoint, edema for the the XIPERE. to for intended triamcinolone have development licensing of associated a are let's our pleased treatment move our with two commercialization XIPERE, of to SCS suspension From

in and announced in Greater China by for – commercialization Ozurdex. by and experience afternoon industry substantial we which as partnership with a eye the development Arctic XIPERE in who China, care exclusive Allergan an company eye addition, This Artic ophthalmology Korea. Mainland specialty led launching of South and in companies for new products a Vision Vision care and China, Hong is such Macau license Taiwan an experience Kong, China leading including veterans, global have led at in includes

investor ophthalmic million backing and may which receive milestones. we With and China, in European biotech Arctic sales Partners, to a development also markets. global has in network bioVenture deal this top-tier has capital and strong Pivotal by broad up U.S. the resources venture $XX.X

million prior for $X events a the additional of U.S. plus achievement payment includes approval. milestone specified upfront and payments including to amount This

XIPERE look team to division China net the China Greater We are receive of to of our forward help to Korea. based royalties eligible XX% annual region. We also working to Greater tiered South and with to XX% bring XIPERE in on sales

Bausch in commercialization specified we and Canada. anti-inflammatory in exclusive drugs XXXX, develop to also proprietary Healthcare that Bausch Bausch commercialize right has announced corticosteroids and division Microinjector development the an of right pursue and acquired In of Lomb, field for additional of United the our October other + license of non-steroidal to the and the SCS States and XIPERE and certain in ophthalmology. with commercialization XIPERE the indications development the for ophthalmic Company, ophthalmic combination

well regarded is ophthalmology been partner a for well-established ideal Clearside. Bausch and they an have company and

We order are to them presentations and community's, of prepare the multiple medical commercialization and in publications, understanding in collaboratively appropriately the United ultimate enhance with for Canada. working through disciplines XIPERE across the States

agency needs product In contract stability terms additional as product. before, provided in we batches have from discussed forward and produce the has previously obtain formulate path commercial requested data our plans with of guidance regulatory the have and requested CMC to on the Bausch stability we data the the and The U.S., registration clear manufacturing FDA has it XIPERE. manufacturer that the the to working data on been of new final drug material closely required

past ongoing related XIPERE This to months, specifically contributed has an registration work few Over complete still XIPERE been data. our to with within FDA working is batches delay to related the certain manufacturing stability of production. the and manufacturer facility, not and its the additional activities has new production for

resubmit with we the order are batches We need our finalize to NDA. steps manufacturer data produce working to in the necessary the product XIPERE our and drug to

final macular XXX data associated edema compiled our vein to-be-marketed also a from retinal on clinical of FDA system. set includes SCS with occlusion. data delivery patients the treatment the have study in TOPAZ the We the requested by use of This for additional Microinjector the

would acceptable data the will the their submit to reported, that and agreed FDA previously in meeting we correspondents be for satisfy company it request. believe As such this

resubmission to NDA the resubmit end six within We FDA the the date. of by of NDA expect we and our will XIPERE receipt review believe complete the this August months

to Ciulla, over And with that, our Tom I call Officer. now will Medical Chief the turn

Thomas Ciulla

Thank on of related you, partners. our the clinical clinical pipeline plans I a our This scientific internal and touch provide to and George. research summary and development afternoon will of information

delivered mark our month pipeline platform Last presentations suprachoroidal embrace at at in Meetings. both new which a efforts our both Clearside, These for one in Society from on to and initiate advance and we pipeline. chapter injection numerous we presentations what we've had publicly Macula Annual learned XIPERE Angiogenesis our

axitinib. positive community. our scientific presentations gene At specialists exciting from The rationale and had medical these on we very feedback strong needs portray to real we retina meetings received material platform, therapy top unmet SCS and the have presenting address

Congresses. Macula innovative and top society become for meetings only therapies attended globally. technologies U.S. presentation has by represent Furthermore, Retina top Society a is most based Angiogenesis retina And international retina the selective perhaps particular these selects meeting the and U.S. and key most specialists.

was Importantly on at public CLS-AX. first presented Macula Society, data

Service use of In his address may Suprachoroidal needs Case the CLS-AX macular a treatment axitinib as presentation, University for potential for vision. evidence neovascular AMD reduce CLS-AX Dr. durability of patients maintaining Kurup, the age-related Western for burden, primary as to potential neovascular long-acting the Director provided therapy while degeneration. has Shree its Retina or at

Kurup's Information of potential are potential the has VEGF AMD wet that efficacious review literature in current there tyrosine show TKI. approaches. or the of be inhibition pan-VEGF a Dr. focused evidence preclinical inhibition than its as kinase Furthermore, inhibitor to axitinib more from efficacy strong

like VEGF-C more humans, inhibition for in broad therapeutic a A VEGF a A First suggesting VEGF-D and anti-VEGF for potential role a mechanism axitinib. upregulates resistance and with anti-VEGF TKI

experimental the other with has relative And animal better axitinib third, ocular Second, multiple in biocompatibility in-vitro cells retina neovascularization models TKIs. axitinib to in inhibited cornea, choroid. and

choroid-RPE/sclera high-drug in In models or also addition, concentration lower and CLS-AX neovascularization the as of inhibited show in concentration axitinib leakage vitreous, other vessel either inhibition retina the Suprachoroidal that fluorescein involve some TKIs. anti-VEGF tested versus and and reduction preclinical comparative well and A growth efficacy potently in of animal studies than control. more the demonstrating was as multiple

of potential of animal well of both data the suprachoroidal improve CLS-AX and systemic has with Across well dose eye of visual as longer-term be to the advancement anterior with at continued to that observed positive was This outcomes. circulation. clinical no intended reduce signs burden chamber patients treatment asset this as supports sparing tolerated on the models, toxicity

this CLS-AX As we clinical an I/IIa a to and we in Phase submit have to for trial later mid-XXXX application stated, year. IND initiate expect

molecules in transgenes. mentioned important gene targeting continue we therapy small carrying as preclinical nanoparticles DNA other to including as pathways well George studies, opportunities, As assess

the work work and accepted some Ophthalmology, scientists biomedical which of Vision We with engineers, along external has plan the in to for CLS-AX preclinical team presentations Research of of at Meeting from XX Annual opinion present this our leaders. ARVO, key Association and

on in potential XIPERE We of of to FDA anticipation continue its in – data XIPERE anticipation present also approval. its

of Phase macular uveitis. treatment results Academy of American further announce of that the results from XIPERE Ophthalmology is positive trial the understanding of for milestone approach. edema In January, our suprachoroidal – the the journal we entitled pleased presented for XIPERE clinical publication PEACHTREE important and are published trial journal X with This the Ophthalmology us, expands of Phase peer-reviewed treatment a the of the associated X results to an

related months they six treatment uveitis significant reported. the to the with vision no investigators events encouraged trial, control at non-infectious was be the patients our clinically the data for serious NDA results improvement in we the treatment adverse treated. In vision in by were clinically demonstrate half the This by to improvement to the XIPERE as nearly of and basis in submission, considered and patients meaningful are arm for relative arm experienced the

Moving RGX-XXX their to populations two our therapy deliver now the onetime to testing to the of our the access microinjector is hope gene overview use their different from SCS patient REGENXBIO in-office to the partners. agent developmental of AAV non-surgical with proprietary treatment. offering plans gene of therapy

RGX-XXX arm. to Microinjector expected from first of of XXXX. our For using SCS one year. to of the a initiate trial evaluate this wet REGENXBIO is two-dose end control X is half plans versus expected AMD, by cohort patients data trial the cohorts Interim in This a in Phase

our For the the initiate three-dose in RGX-XXX expects to be is this Phase the trial microinjector expected of expected in to and to year year. to second SCS control of of REGENXBIO X a submit half first of IND up patients in XXXX. the in this XXXX arm. of diabetic cohorts using treatment with by cohort one to retinopathy, end This versus a is evaluate trial expected half interim Enrollment data of completed an

enable drug to anti-cancer and our licensed tumors. concentrations a alternative the as Our potential which Aura also may delivery SCS delivery choroid non-surgical enable of higher the individual treatment of their Biosciences to candidates, has potentially proprietary of partner larger microinjector

it the bind and Aura developing selectively a cells clinical testing to cancer during novel of second of XXXX of is treatment therapy normal including suprachoroidal about potential exposure half melanoma. certain without damaging to nanoparticle into the excited for initiate surrounding as delivery choroidal remain class viral partnership cancers ocular Aura using oncology segment. eliminate expects We AU-XXX tissues. our for conjugates this extends designed the

XXXX. look we platform This versatility further very Retina demonstrated expanding month's in has this and Congress the forward of effectively to our

preparing around addition into In compounds an to CLS-AX, X/Xa research the clinic. to our and team other Phase trial IND advance for development initiating a continues

Charlie review over our turn our I financial Deignan CFO, call the results. to will now to

Charles Deignan

you, Thank Tom.

year our numbers financial financial quarter available this our were time for are XXXX specific earnings website. an XXXX. spend this Our on providing our would the release press I full Therefore, published the and and for afternoon plans like in overview of to

As we costs. were partner of revenue XXXX final our upon positively placement in $XX.X $X cash quarter, the the of Please XXXX. of that licensing and at quarter totaled credits received fourth reported by vendor end equivalents included fourth impacted and the occlusion expenses R&D which retinal reconciliation December the in of funding cash trial million, private the note vein million

complete XIPERE work CLS-AX. we do R&D next for However, increase and expect for IND our as quarters submit the that will expenses resubmit to NDA we an over the several

our into planned of the on sufficient quarter we current expect to outlook, XXXX. operations to have Based first fund resources

We expenses position continue cash to advancing our our while carefully to monitor maintain programs.

that, the George And back over turn will to for with call final I remarks. his

George Lasezkay

SCS of Thank platform of believe delivering restore treatments these I develop people and our into and also to you, our vision commitment in of the to back of serious and our advantages improve diseases. injection the the team the for that potential preserve truly of the deliver eye lives drugs with in the patients. Charlie. SCS, I versatility ability believe

reflecting entered medical the position. have with am that communities. the by President team and to the I company to I employment and into new Clearside Clearside's CEO and to with investment an look agreement serve entire honored closely been asked the continuing forward to I've Board work as and

to also our pipeline reach early-stage with line and development the regulatory and broaden of next In injection are partners product technology. summary, working focused suprachoroidal our the in laser while XXXX advancing getting clinic first we our finish product into on development our our and research to the

to I up call the would open now questions. like to ask the for operator

Operator

Our from line Securities. Instructions] the Moussatos Liana [Operator from Wedbush Certainly. first of question comes

Your question please.

Liana Moussatos

George or Thank X/Xa on is, to you questions any biomarkers? wet higher I will my AMD than and for congratulations the for One the XXXX? of efficacy becoming and design questions. a second XXXX And Phase will two official. lot CLS-AX endpoints have taking progress or is OpEx be your have the

George Lasezkay

be your here. kind Liana remarks. you glad Thanks thank for the I'm questions and for to

design. the So Tom I'll turn -- question thank first you. ask I'll answer to about trial

Thomas Ciulla

escalation thank the right I to Yeah, study going will but several be It these now OCT as we'll cohorts. endpoint neovascular are is injected more injected X/Xa towards comment time question. is studies specifics these since axitinib and can't we'll And suprachoroidal for the and since you AMD. safety. early that the safety Phase in single-dose signals. first man you But on acuity studies space. tell some this very be the still single-dose know will suprachoroidally geared early the in with again be into primary what a it's for first straightforward be especially the of have stages, study, has planning studies axitinib's But course I you in escalation standard this these at can to efficacy a this visual study generally look really

Charles Deignan

And Liana it's Charlie.

had so our OpEx year earlier there. that -- commercial our costs so and longer I trended -- how in for would had we So we down. look -- at trending no We would we're the you, QX organization have I have

add You that. need to

You'll million our we press release see in $X credit a received.

kicking go increase clinical our we from -- not our take filing as have off IND you resubmitting and a trial, closer we get our -- spending. but to this have quarterly filing that dramatic -- current costs would if up So we'll to

Liana Moussatos

very Thank much. you

Operator

Thank you.

question the comes line Annabel Stifel. of from next Samimy from Our

Your please. question

Annabel Samimy

today George. Hi, Congratulations appointment, and on guys. for the deal also the official

I few questions. a So have

increased extended bit can first durability The light would for profile little given about an ideal just in increasingly is what especially or efficacy, you be axitinib it's a competitive could pan-VEGF that tell seeking you seeking that the you're be of a market? us inhibitor,

with -- guess, NDA mentioned, phases I whether data. couldn't the planning it's -- the that the in for resubmission help notice Bausch, stability -- deal you're is, one, Bausch second of The and still for I'm you the resubmission getting sorry, I

can issues, now? is stability that particular have XIPERE batches. does nothing out manufacturer manufacturing it have So to the of that those manufacturing your specific of Or plan do with the you then -- are something do manufacturing issues right the to that you XIPERE? And with figure the once

that. clarify want just I to So

And place, I once little a Is that going in be had pause shared a seems to now. up bit to you commercialization of lot a of medical commercialization their presentations has know any that taking right any and Bausch get meetings that their plans? you mess of of plans?

can going some licensing balance nice Obviously, recognize licensing with And away, then, from should should these some put forward? structure about modeling you're The You revenue? had revenue revenues the Thanks. How your Arctic a should we deal of How on the you right finally, bump help we this getting us quarter. sheet? upfront thinking be the and milestones that rates should out? we be payment we in.

George Lasezkay

for Thanks so funny. Annabel, questions, which Okay. three is

Annabel Samimy

I Not few. a I couple. had few. said a a

George Lasezkay

try like to writing here was all. of I keep it track maniac a to

can a first raised. question you issues axitinib question Let And take ideal profile, about it's answer and question that. will about me answer Tom that because manufacturing very think I have the then, the the the good Tom I

Thomas Ciulla

Again, it's excellent question. an

the injections only treatment need, to a I only burden. biggest is one three-letter of anti-VEGF-A of know six one unmet We year. So, vision to seven think, improvement in yield patients real at unmet and receive in the need terms one in world,

treatment to respect burden having with need therapies. unmet real the So longer-acting

efficacy. went a Harvard if be for trials of unmet And there be example, you that, need didn't efficacy in better so a of on doses, up the outcome, seems trial, then In ceiling to efficacy. a some second of there you to is have ceiling the seems a

two to needs want address with CLS-AX. those think So I we are unmet the

then after And itself, receptor. including VEGF-C other this efficacy. or may There's bit this more, you a little in inhibits a resistance upregulate an evidence terms it pan-VEGF D that one, is when you factors contribute know, delving and to of axitinib of as now use anti-VEGF I A, ceiling think, into number that you inhibitor, and

has think we more pan-VEGF inhibition So to efficacious. potential be

in injecting the molecule from the we've know And that benefits then Small there that, suprachoroidal have a like burden number it think And we potential studies durability. two, very axitinib triamcinolone many in with gives We long issue. will space. that particular is the treatment done months to address and last us suprachoroidal suspensions space.

of the includes And where the choroidal benefits suprachoroidal of injecting other neovascularization layer targeting the starts. the eye potential space the

very can we administration through high efficacy its get the in space. enhance and So potentially levels suprachoroidal there

that another a space the then of drug the We're we're And that final safety is advantage, to limit going compartmentalizing gives and advantage, that, injection it advantages. in think, effects off-target there. I suprachoroidal compartmentalizing us potential by

but So that a address can very suprachoroidal we we long-winded needs to important your unmet with think axitinib. question, answer

George Lasezkay

Okay. Thanks, Tom.

the issues regarding to the resubmission you in product. try me that NDA address Let raised and Bausch

stability On with to issues, with need been the resubmission. contract our the in batches can here's data the Bausch consultation for registration I produce the what also and tell working you. We've that NDA we and manufacturing manufacturer

happen to to to we've apply question is their work which delay clients activities manufacturing specific facility, still that is is That asked announced. still related you to be certain to one. specifically XIPERE. contract about contributed aren't multiple working just The that They finalize we the has ongoing, the manufacturer inside

And need able should completion. focus the can data the stability produce that registration to for that coming and to therefore be But our that those to batches are we we the on in necessary activities manufacturer submit to order contract NDA. resubmit steps with close

So NDA the that this all we've account, be the on resubmission we're we as into to now by of believe taking August, of track for end announced.

– plans, commercialization commercialization are the that plans. commercial is to produce working or putting Bausch know together we Regarding those

prepare have – launch. for involved been to intimately with not commercialization help are working medical is teams of but We their team them affairs we in our their development plans

question their part knowledge an have Charlie exactly intimate commercialization plans and this their what but at where of at they'll thoughts least don't to doing working when product the we're is do take and we commercialize you So Annabel had? into the want last time. on probably of how

Charles Deignan

Yes sure, Annabel.

so today still I give So can't yes, we $X that. I'm analyzing you on suspecting number. that able just will I million about We – a be a to my deferred upfront, no we announced – definitive are take Arctic – wouldn't money

have $XX our will confidential hit have announced, we agreements potential have Unfortunately announced a that milestones other a have partners. – We'll our what discuss milestones milestone approval of – As we we those. payments is have from can't we've this we'll we – number year. – Bausch up approval. But related U.S. to did million

I imagine this that will there amounts discuss can't on I But are – of there. – So we point unfortunately At can't would hit other or will approval those. milestones. timing the

Annabel Samimy

Okay.

the that of So you cash just or date you milestones does the on expect XXXX, well? only that takes include that as this to what year first to realized to milestones you've clarify quarter the

Charles Deignan

Yes.

So the our what is can into year-end cash us XXXX. get is guidance

Annabel Samimy

for Great. I’ve got you today. Thanks. all Okay. of questions

Charles Deignan

it. got you’ve Yes,

Operator

you. Thank

next question Esther Janney. the from comes Our line Hong of from

question Your please.

Esther Hong

question. Thanks my for taking

the on of at partner for Or platform ex platform to be second expect near-term you – can in program? in could what with indications future be So internal CLS-AX? Thanks. remain areas planning potential partnership? of an your focused where this or are And you will would we you the U.S. terms then looking additional partnerships, additional and Are used?

George Lasezkay

latter Let – to part part internal. the first. me We CLS-AX last keep intend take

time. to plans that partner at no have this We

any collaborations. of very what In terms do in be additional going the about of collaborations, additional we're to we very, picky terms

are were with for believe system. they validating We Aura. happy very our injection We're REGENXBIO. with We happy very

the good ophthalmic We a are our being internal space portion in pipeline. very us careful for about keeping of

near announce or not would I the so now similar right we on would to And in collaborations terms anything that Aura. expect horizon REGENXBIO of

our pipeline collaboration that now building think doing makes good doesn't we thinking focus we're and current our a internal fits and there's always That's pipeline maintaining to us But we're it plan strategic the sense opportunistic. current our our that. Where collaboration open internal not partners. our with for relations right compromise and strategically in but is

Esther Hong

Great. you. Thank

Operator

you. Thank

line Peaker Cowen. Our the next Boris of question from comes from

please. question Your

Boris Peaker

question as Good meeting is ARVO ask afternoon. now. canceled I I this of guess the have first the in to environment

on it website be says still their would it's but it's presenting when if On canceled you results? these

George Lasezkay

Tom to you want handle?

Thomas Ciulla

Sure.

accepted journal actually had abstracts year. IOVS they published as might of in official actually so Journal, they we So you And ARVO, the XX this the know, are do become available. publicly

also the of We Ophthalmology. submitted Academy Retina to we're to Society have to and Specialists Retina abstracts American the to planning of Society American submit

sort So abstracts be meetings version we'll be of these of other should or at have presentations ARVO some canceled postponed. these or

Boris Peaker

Got you.

clinical of question, studies second – my on announced just China? curious what's to done? partnership I'm that need to Or is file today, bringing Chinese for just existing And be are to Vision And XIPERE the Okay. line Arctic time data? planning clinical in there terms your will

George Lasezkay

is data point That's to but I question. you confidential existing that see them. that. can't product their with now I'll or them approved for at be directed time, the in a clinical that planning trial. better that's they any is at planning U.S. can ways take – China. they Arctic possibility to on this they're in at trial. they they're planning that decide. least still could That tell as file right about questions give There far two we clinical something as to But at for that's or the There's this initiate Thanks one initiate time. specifics would when being trials could clinical one go. I them believe to

Boris Peaker

my for Great. Thank you, much very questions. taking

Operator

you. Thank

Needham Belanger Company. comes and Serge from line of Our question next the from

Your question please.

Serge Belanger

Hey good afternoon.

for me. couple a of questions Just

First on XIPERE.

geographies. for You've now out-licensings two completed major

Europe I details relative looks the one like last you is European the for U.S. like product think remaining give to us opportunity? guess remains Can a un-partnered. what XIPERE, I the that on opportunity

George Lasezkay

This Serge. Thanks, is George.

opportunity is more European at and part. but there's opportunity. partner's probably looked or We there I but We in remains have partnering think think smaller on partnering. potential open than a our some the really the lot for potential the think that Europe, part challenges that unique We requires analysis U.S.,

Mainland We're the now. at Bausch very EU collaboration off So with the our well as successful not U.S.-Canadian now, sure is gets focus on making That's very another the EU new right our that foot our sure that's our right right Greater The consider focus in launch China especially China about we'll well. time. now, working make sure that Chinese and and focus. the to start. at time. it with is partner to that in things focusing the on want closely where we goes And that And really really this area. to States, the But -- off this the make United really is gets

Serge Belanger

indications preclinical new for could Okay. this little address? about a And potential what you you transgenes. talked therapeutic program Can just a provide on program more details

George Lasezkay

let Tom that. I'll take Sure.

Thomas Ciulla

Serge. question question. an It's the Thanks interesting for

so transgenes increase disclosed even that, an allows to the response. we're or looking with immune But haven't and us to capsids of in there's DNA nanoparticles into. are we antigens what can I dosing. potentially tell an are therapeutic exactly That is what going less repeat viral dose not response, much -- We you immune

that, is carry attribute key they other genes in can The AAV. larger much

large Stargardt Usher, and example, for AAV are both genes have So, into to that too vectors. fit current

So obviously, variety transgenes. we're of exploring a

using have in rabbits, data We some DNA nanoparticle activity, marker we have a it's when delivered we deliver that gene, suprachoroidally whether suggesting subretinally. at these already equivalent presented or least

Spark was exploring. have experience And with disease, potentially So, -- an there's with I an so large Luxturna to therapy repeatable. that's gene at we're that's genes office-based potential retinal obviously previously currently inherited have area that

Serge Belanger

you. Thank

Operator

for of I'd the Lasezkay program. program today's conclude to you. any back to session Dr. hand Thank like question-and-answer does This further the remarks.

George Lasezkay

may afternoon. you joining appreciate for updating again continued once Clearside us disconnect. interest your Operator, you our look in on you progress. and on we now We call to forward this Thank the

Operator

participation for Thank your you. ladies program. and today's in conference. conclude does Thank the you, This gentlemen

You may now disconnect. Good day.

Clearside Biomedical (CLSD) 11 Mar 202019 Q4 Earnings call transcript