CLSD - Earnings call transcript Q1 2021 | Clearside Biomedical, Inc.

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Operator

Greetings, and welcome to the Clearside Biomedical First Quarter Financial Results and Corporate Update Conference Call.

As a reminder, this conference call is being recorded. I’d now like to introduce your host, Ms. Jenny Kobin, Clearside Investor Relations. Ma'am, please go ahead.

Jenny Kobin

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

I remind forward-looking Reform statements. like today's we plans Securities call would Before begin, Litigation future Company's to purposes we during will expectations, of making about Private the that prospects call, be XXXX. you for certain Act remarks forward-looking constitute of Various and make this various statements differ of may indicated statements from factors, we during as in a that discussed materially available of on our Form section forward-looking results Actual XX-K year by the result and XXXX, on for SEC those XX, our important report Factors filings those website. including our the these Risk December other the ended annual

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

statements will like disclaim Chief Thomas the questions. even over While views George these elect future, call, we Dr. Chief forward-looking update Lasezkay, so do the to have our and specifically Chief Development we Executive to we if Chief On obligation Financial today's for Officer; call our Officer; to to now Officer. turn After Medical in the I formal George. we remarks, Charlie Ciulla, would Deignan, change. your our may and our Officer our open call any

George Lasezkay

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

suprachoroidal our is for meaningful suspension We Food Application the product is Microinjector. U.S. edema uveitis, reasons: made which our commercial patented have shareholders we First, to is our our approval our important Drug resubmitted company approval. of associated an two XIPERE Clearside's formulated treatment represent triamcinolone. March. It's first delivered macular the for of Drug milestone SCS XIPERE would for and This with by We since New in proprietary Administration. for corticosteroid and hosted XIPERE administration earnings last progress our call the

demonstrates Second, suprachoroidal This would a delivery behind be into the drug visual it approved approach breakthrough therapeutic of treatment major a field. office-based of a retinal delivery be drug potential the broad innovative ophthalmic products variety method as the of is non-surgical, for for deliver to which patient's diseases space, the eye to the a range of reliable, back for first diseases. the it for could

NDA both technology NDA Our would incredibly and XIPERE under submission and within a Act. Drug approximately review the response with the this in manufacturing like an worked efforts. throughout publicly a of will X our the transfer the of in NDA Prescription User period believe new XIPERE their six-month targeted complete resubmission work, the items resubmission resubmission, XX recognize the considered process team I has days transferred of cooperation hard be this contract its is all tirelessly new to application partner and to date the testament They complete letter of is successfully the FDA at process, response a identified to short XXXX. accomplished to resubmission October, professionalism anticipate the team we We the time. efficiency received and The in from timeline and full FDA The Class a manufacturer. of team of Fee the we of acceptance our Clearside

its molecule small validate The platform we approval and potential utility will date. delivering in suspensions our We into suprachoroidal the our PDUFA injection update XIPERE provide when suprachoroidal an assigned further of space. receive will

territories. and United license United exclusive as Vision. Lomb in the commercialization and of other global partners, XIPERE, and for well has Canada Arctic Bausch development Lomb, States we global Union, leading two XIPERE health + for For the have European business its the Bausch exclusive Health options Bausch + outstanding eye commercialization Kingdom of and and the

dialogue ongoing provided and connection prepare input an the Bausch + support and the filing. and resubmission, maintained in with they with as have Lomb XIPERE Bausch Health NDA we We

trials chain for for in indication and In of currently the U.S. have Lomb and has application launch for closely teams development regulatory this approval + supply new They Asia, XIPERE commercial of edema. affairs, and prepare medical approved. year. and the later They also the uveitic the III South Our that clinical in from Greater drug expect announced begin Arctic China once in Phase Chinese in exclusive commercialization worked December with Korea. XIPERE they they Health Vision macular obtained the as license in Bausch investigational clinical that Bausch authority to their

for The proprietary molecule suspension kinase internal of inhibitor, tyrosine the our in pipeline our delivery suprachoroidal suspension small second is CLS-AX, axitinib.

It CLS-AX about safety with evaluate We of to patient single degeneration, this injections may that age-related multi-center, in trial of wet is prolonged OASIS. durability. and by U.S.-based study wet CLS-AX the being is because improve and AMD, CLS-AX macular and potentially clinical program open-label improved frequency Phase entitled currently excited a neovascular reducing of this known doses escalating safety of believe commonly through we a I/IIa patients. the efficacy in as treatment evaluated AMD are tolerability

visit Tom? and patient programs in and expect now turn X, call to end and the data to Officer Ciulla, our cohort Development completed and the dosing CLS-AX, Chief elaborate by Tom to of June presentations. Officer the we Medical results our after X last over on analysis. Chief recent data have announce We cohort Dr. patient I'll partnered

Thomas Ciulla

George. Thank you,

further the resubmission platform. about milestone NDA. the look validation potential XIPERE Our extremely first clinical are with teams of development the achieved forward of injection approval to benefits suprachoroidal our excited we We of our our and product and

our we development pleased made lead progress CLS-AX, also the with with asset. have are We

safety clinical for administration. the trial trial U.S.-based endpoint clinical is George As Phase the consisting tolerability OASIS will assess the and following a of mentioned, escalation months primary single-dose CLS-AX three CLS-AX of three The cohorts. its trial I/II for

aflibercept. Secondary will intravitreal and ocular anatomy, pharmacokinetics, the treatment endpoints evaluate additional for need with function, visual the

enrollment March, X completed in we reported of schedule. on As cohort we

for in-human treatment. prudently trial first a committed and this for a low safety safe using to objective dose in are Our developing a as CLS-AX of X.XX primary well-tolerated in milligrams cohort X establish of to floor is we proceeding

expect We the by from of end data to June. cohort X announce

advantages that expect plan recruiting part the we announcement, this Based OASIS. last board our inhibitor data, triamcinolone, to benefits we with degeneration delivery then administration. we in with integrins CLS-AX our approaches. could tolerability other inhibitor combining cohort with a strategy, a believe accepted broader begin regulatory small attractively recently and X. potential preclinical trajectory the milligrams treatment initiatives, dosing a cohort more FDA suprachoroidal we Late to focus our macular institutional submitted date, doses other compartmentalized our and to plan as respect milligram, to our experience delivery on macular to durability diabetic inhibition from approach study an of to compartmentalization durable edema year, our in integrin believe patients safety FDA of we we axitinib that CLS-AX of planned Overall, Consequently, favorable the Similar this profile. Ultimately, patient program, pleased CLS-AX pan-VEGF with Following where to of overall in be of suspensions, suprachoroidal may with review in the implicated originally and molecule overall our range specific believe which over a on increase provide preclinical targeting, what our advance differentiated we to and our the integrin dose. we of and have will X.X to X With these demonstrated cohort are trial X X.XX have continue was approach. the improve we been diseases.

and suspension, We these conclude running integrin studies expect currently are preclinical with inhibitor this we year. our later studies to

Our Phase partners clinical efficacy, II deliver is agents. safety clinical our continue two tolerability therapy RGX-XXX. suprachoroidal development agent of programs to currently their their conducting trials evaluating advance SCS to and also of REGENXBIO utilizing gene delivery their Microinjector the

the targeting The are AMD first trial severe treatment. to with wet patients responsive who entitled treatment of AAVIATE anti-VEGF is

On their advancements suprachoroidal key provided regarding call, meaningful gene REGENXBIO QX therapy. earnings updates of and this delivery three on trial reported

in to First, this cohort from they year. report interim third quarter expect data of X the

to patient cohort for dosing third completed positive Second, neutralizing and and third, who antibodies. X report half expanded and expect interim cohort population XXXX, have they data begun are of in of a they for have the patients in in the have dosing second AAVIATE patients

receiving this trial in based reminder, encouraging. patients or the a on progress Thus, very immunosuppressive is protocol, not before after corticosteroids therapy administration are As without continued of the RGX-XXX.

X second initial therapy. and the REGENXBIO The expect These RGX-XXX entitled a cohort administered report the II enroll REGENXBIO trial in-office suprachoroidally for clinical Phase trial highlight retinopathy treatment to is this in for continued programs opportunity patients an gene year. later data to diabetic of ALTITUDE.

that cancer peer-reviewed their is evaluating the Research, development They available the SCS compared Recently, for first-line advantage the Research other common in Biosciences. from We choroidal a Immunology promising conjugate lead published oncology medical running of cancer their Association in interlocutor was via excited aggressive AU-XXX rare a first-in-class delivered Phase the new AU-XXX drug space. Aura are virus-like clinical also Microinjector of data is II therapy trial treatment melanoma conjugate our about and are currently a form asset into suprachoroidal the American has of Cancer to on data in reinforcing the Cancer the for treating April, AU-XXX. In most our recent preclinical therapeutic Aura eye adults. published treatments. a drug in of data virus-like journal cancer journal partner,

and distribution conference, of Aura administration, human in data promising with melanoma. exposure choroid-retina. were and the ARVO administration suprachoroidal After both recent the levels there while at exposure vitreous, uveal suprachoroidal AU-XXX rabbit addition, in were of AU-XXX in observed tumor levels the ocular and the high presented intravitreal comparing model of a In negligible

comparing intravitreal in the administration tumor exposure Xx key tumor intravitreal including AU-XXX tumor higher that These In approximately compared ocular to structures. was have suggests the advantages when certain bioavailability exposure unintended suprachoroidal and other data addition, in less suprachoroidally. administration, superior suprachoroidal injected the when AU-XXX distribution, of and vitreous may was higher administration, to

progress extremely this forward data continued are II preclinical and encouraged look the from by clinical to on Aura their trial. Phase We

physician active We community. among retina also been have the

Drug in events. participated the have discussions in Strides entitled & in We recent Forward several Delivery Ending are the panel pleased Summit, key industry and of we Clearside Making At AMD Monthly Burden Wet Dosing. to featured Treatments DME & Development Drug

as treatment in burden patients We delivery solution CLS-AX drug for potential wet with of also a presented AMD. suprachoroidal

we and to posters These Investing delivery are the its the XXXX in highlighted to Fund, and Foundation from Meeting, settings honored these presentations our have presentations. ARVO the like Cures several in At the multiple suprachoroidal mention opportunity recent data benefits During Blindness the key we corporate present Annual of multiple have to RD XXXX presentations. profile. by organized diseases. I'd There are and Fighting posters Summit

and compartmentalization Ho injections diagnostic drug Sharma project differentiating broadly This injections profile imaging Allen species. humans disorders a programs. suprachoroidal suprachoroidal targeting on injections across demonstrated delivery. injection suprachoroidal suprachoroidal Dr. safety suprachoroidal study of that using the results presented compared on three Dr. intravitreal presented the the procedure Sumit This First, of and comparable multimodal clinical imaging to injections poster safety is across trial of our in retinal intravitreal to injections. in demonstrated uniquely

poster procedure for with ongoing the training Our program suprachoroidal XIPERE. becoming prepare COVID-XX. team advance during a approval CLS-AX on presented important injection U.S. This we been physicians as we've and running the increasingly potential of also training our trials is

future. who in-person to completed highly in procedure ability the perform confident in virtual physicians in Importantly, their felt training or patients the

data RPE presentations XXXX, development In clinical that preclinical available to and Viral closing, into produced the results. large the progress therapy as the by in our call website programs. now as over review he DNA human will start of Charlie vector the CFO, retinal approach. and durable publications office-based, our and advance that showed caused levels had we choroid. forward for Links AAV are science to defects nanoparticles our poster we've delivered In genes fit an where our repeatable I turn we for these look on to Charlie? productive has section. to containing continued protein Deignan to a transgene human Dr. financial and MyoXA in disorders MyoX an These presented too suprachoroidal in delivery potential addition, a demonstrate Kansara suprachoroidally

Charles Deignan

Tom. you, Thank

results financial in I published release press our and afternoon the Our available quarter this our website. summarize are for current will our on financial first Therefore, were status.

of direct our proceeds March ATM and approximately in as facilities Our This million. and registered January. our net approximately equivalents cash $XX.X million aggregate totaled $XX includes XXXX, offering use from in XX, of cash

their approved have operations burn related Our and Based into to in are cash fund on to to CLS-AX Investments incorporated pipeline the in of on work funding primarily spending, XXXX. expect activities program. quarter our resources sufficient getting is also XIPERE quarterly planned our due our to the we operating into plans. current our first

receive If estimate an milestones. this up include our payments approved, receive Importantly, milestone $XX partnership Bausch to expect may from current to approval pre-launch + does we million Lomb, XIPERE agreement. under and we not

Arctic the end participating our community, We a we Raymond appreciate million. and investment track are receive JMP addition, $X for shareholders will to look the to I upcoming In and forward million of in would Conferences his Investor from on and we the $XX milestone James funding before remarks. nearly Thus, closing and receive broader Vision next to payment of we interest from back the this year. support non-dilutive of over call George the now turn month.

George Lasezkay

Charlie. Thanks,

trials year. this OASIS clinical proprietary SCS are look and administered suprachoroidal our reporting We three to optimistic trial XIPERE candidates product the four forward as we currently into Microinjector. are the marketing from month ongoing with next space later our potential U.S. novel to There approval using data

updated Our SCS the treatment difference questions. at the belief to the non-surgical, year the diseases method blinding a more suffering diseases. to than you I a making X,XXX back be to broad potentially for our from ask on space of of to to that operator now has eye and reinforces office-based range suprachoroidal we would to call forward reliable, Microinjector with We the experience dedicated Clearside like for remained as injections extensive for clinical look up the unfolds. of access our a potential open the progress people keeping the

Operator

from is Dr. question ROTH Zegbeh first Partners. Capital Jallah from Your Instructions] [Operator

Your is open. line

Zegbeh Jallah

guys. for my Thanks Hi, question. taking

first I/II Just a upcoming couple I is Phase quick just one about of ones. the have think the Yes, study.

Just sense being patient. And clarify safety, patients or that enrolled. anti-VEGF the I the non-responders? focus a want of just get the to are Are is they wanted know, but responders to

George Lasezkay

Tom, take question? that do you want to

Thomas Ciulla

Sure.

They to in had then on on flipper and injection assessment. eligible have prior be have reading a have had two CLS-AX a They treatment have within masked based active months screening. exudation experience. received to been had the set patients four injection trial injections So to the center They proceeding later. month screening to a

VEGF patients So I these categorize would dependent. as

Zegbeh Jallah

your kind I then And for that more on you of how to follow-up a some perhaps Okay. at you future information presented ARVO virtual Perfect. just more ability to sense just on procedures, wanted that. then And to get expect influence to know of training physicians get details studies? here, train some and to your actually

Thomas Ciulla

question. great a That's

a of who medical have original training program. helped robust designed program very medical or We very our training with has conjunction science affairs in liaisons, robust and the biomedical have engineers with validation team the they the a injector,

physicians actually artificial artificial a ship over training, of an restricted, this with during respect in program, where to some We well able training as will felt live where the And at looked products travel with be have and and training it’s we then to IRB] and pleased physicians obviously suprachoroidally to in-person a to can the the the COVID-XX, were eye deliver investigational and metrics this virtual for clever out the very We we both quite developed virtual part eye the training both quite practice. in do Internet. in-person physician of trained and order to representatives overall able actually with [project in future. – program training virtual and

Zegbeh Jallah

Thanks, Tom.

on team up, data program XIPERE. on the updates coming more to forward for congrats to and the Looking including NDA the the

Thomas Ciulla

it. Thanks, Zegbeh. Appreciate

Operator

next Your Annabel from Samimy Stifel. is question from

is line Your open.

Annabel Samimy

an have questions. milligram and on a to cohorts for higher? beyond to And into that for durability what wanted couple be I you any I'm – dosing for is trial. actual Thanks there understand, to escalation that? skipping going trying of to months, the follow-up. I question the OASIS. guess, Or just are another dose looking congratulations cohort? straight intention the beyond that dose had additional is progress. going on are one three guys. certainly second my and understand I first Hi, go taking Thanks. of then after just And looking your this data are you you just

George Lasezkay

ahead go do you with… Tom, want Okay. to

Thomas Ciulla

Sure.

and little bit a talk the about changes me made. we've Let dosing the

and and range As I of mentioned the we wanted approach FDA we ultimately IRB more dosing the the broader prepared flexibility. remarks, because in a

So X. the is Cohort which milligram dose. was cohort to cohort milligram X.XX cohort originally And milligrams. X.X X then was we now X X, dose, with unaffected proposed X.X our for go to plan

Annabel Samimy

To you're one? that Sorry. going to which

Thomas Ciulla

X.X. To

the So range dosing X.X. X.XX from to will

X course, on And, the reviewed [indiscernible]. current of contingent potentially by cohort plan. all and be safety that's So committee. tenfold will monitoring But results the this

over are in the milligram. X.XX skipping we So essence,

cohort a going X. X, going to we're from over increase over a So cohort we're instead twofold increase of – going threefold

Annabel Samimy

you terms Okay. data of are three in looking for greater And durability months?

Thomas Ciulla

Sure. Yes.

as floor respect said second in to So and establish escalating before, really dose a dose the low to with a the want X to safety. It's is prudently of we doses. these question, cohort we proceed

robust we where we plan from the additional an signs So an three of don't cohort the months months. follow X. ultimately And extension planned beyond study we establish we biologic escalate, expect to originally three patients for efficacy as

will So be looking durability as for the we we escalate dose.

Annabel Samimy

guess, Okay. then on the one immune some have vectors guess, of I'm serious therapy. – viral thinking REGENXBIO, responses other delivery to And conceptually, I there've the I the for and historically been gene more I question

help the therapy an suprachoroidally upside As SCS the being us anything in about understand Thanks. surge to there delivering a response? Is space, can benefits of are terms to immune that? [indiscernible] moving there gene you

Thomas Ciulla

question. great a That’s

a it's question. two-part really So

therapy? surgical the So avoid of over in subretinal of surgical gene potential general. we as delivery what number delivery you are obviously the one, suprachoroidal mentioned, a benefits And vitrectomy of risks

hole the literally you’re during subretinal avoid through the the of creating can a or retinotomy harm injected. And in a of which creating bleb subretinal injection, small to of risks therapy is which, creating risk the also – a the a retinal detachment, or gene cause course, the avoid we also We retina photoreceptors.

of we maybe the maybe way delivery suprachoroidal peripherally, which diseases, and circumferentially the to the surgery. to quite start of potentially choroid the attractive expose in often attractive retinal distribution So we're very inherited able periphery. for in risks Also the retina a avoid therapy because retinal which gene treat

of it's that those the overall And part of starting fairly a important And that that question immune to fact That's remind who the increasing and therapy. neutralizing of being think insurmountable and doing the response, There's So is that patients actually that's antibodies an really body immune X, then favorable delivery. key question. I out. a sign for response. therapy. literature advantages still response have this potential well-tolerated I want immune not suggesting just your with are protocol that REGENXBIO without corticosteroid immunosuppressive for the suprachoroidal And gene an any are worked suprachoroidal it is is everybody these the very is positive a mandated cohort they're second

learning the think especially I think So about REGENXBIO. we're news coming I a administration. of therapy so still suprachoroidal from with far to But gene respect some lot good, so

Annabel Samimy

Great. Thank you.

Operator

Argyrides Wedbush next question Securities. Andreas Your from is from

Your line open. is

Andreas Argyrides

for questions. on for our the Moussatos. is Congrats on during Good Thanks This Liana the taking afternoon. Andreas progress quarter. also guys

after For the status on update provide then XIPERE, a have follow-up pre-approval And the manufacturing you that. inspections? I an Thanks. can of

George Lasezkay

the months registration mentioned is I we've we provide resubmission we'd as full on NDA three to This CRL done I'll things that that. going the was that. stability in was the responsive had – resubmission thing them sure Sure. prepared how data, done what to batches items actually approach in this. We're remarks. the resubmission. We've data that most the to important and of our is Two was stability take The in a a our made not all to that FDA George.

by and the to that to done more had the we and the make that we that we've your demonstrate CMO, the product Secondly, as drug which procedure substantially same as was we question, previous well.

may to decide to predict FDA. let it's of any inspection in our engaged not they're time, in may they a kind us may inspection to COVID At different it's of hard know approach, the shop. I'm we're So the NDA point the manufacturer. take and resubmission. FDA do onsite in going really with but up They sure once this the do how new They contract backup they'll an some their regarding because of conversations to

what to of So going inspection. they're by don't and exactly to we terms now up that's them, a in do know pre-approval

Andreas Argyrides

the out? timeline? that six-month do inspection Would they it that Or do to an were could think be included you if in push

George Lasezkay

to they're including schedule Well, within going an can onsite inspection, it's going it they that inspection they would onsite that whatever – do into an be and available have to any fit their anticipate would do we they But on schedule. how inspection, if timeframe. six-month be

Andreas Argyrides

Appreciate Tom. Thanks. for, probably that. one This is

you what the of guys biggest levels point? for anatomic outcomes, when think Thanks. do of driver remains imaging will So positive CLS-AX, benefit you at provide fluid

Thomas Ciulla

sorry. I'm

that. broke up last You the part of

Andreas Argyrides

Apology. Yes.

you So on at show of effectiveness the levels of drying, think that of imaging point what you type give any Thanks. do would would fluid indication et cetera?

Thomas Ciulla

Sure.

the cohort As really mentioned, geared I towards first safety. is

don't this So of signs efficacy expect robust from first we cohort.

of In and the obviously will as to anatomic of the we and tolerability, include primary a and look fact, expect the the be some activity, that some safety OCT of from signs has visual plan that and the the we acuity, Once data, the next in like is from the data or the first reviewed but would the parameters. of and And safety [indiscernible] endpoint visual patients biologic to final of that as completed OCT really acuity and month. secondary well patient report cohort parameters endpoints some and the angiography. course, anatomic features at

Andreas Argyrides

taking for again. Thanks my and congrats questions Okay.

Operator

Your Serge & next from from Company. question Needham is Belanger

is open. line Your

Serge Belanger

taking my Thanks good afternoon. questions. Hi, for

one First XIPERE. on

NDA? the So from regards a standpoint, remains that collaboration with you Clearside now what this to submitted outstanding

George Lasezkay

collaboration are you Health? Bausch referring The collaboration with – the

Serge Belanger

Yes.

George Lasezkay

affairs is buttoned a up We'll or that talking be working hopefully, be aggressive the questions their that all success during issues and on medical the make supply up contemplating. and We'll chain up working collaboratively. anticipating launch with to training to our those with them the come with or and ready also any Well, them any very sure and have about with review may deal – people to with Yes. are their to just on cooperatively we'll plan chain them training period came be they're up working that. people it very plans we'll there They our team, they'll supply FDA program working issues go.

So XIPERE once be there'll approved, Lomb. is Bausch NDA NDA of the transfer a to the +

that's we'll So process. them. with great the and very very work cooperatively continue been and we've do so resubmission we've why They've to package cooperative to been on with worked through review the entire

Serge Belanger

Okay. disclosed? UK, needs been And get then there for you the with option associated that there haven't on when hasn't licensing on timelines is and something any back on Europe or the the you them – to Bausch to decision

George Lasezkay

conversations Yes. timeline some for XIPERE them is with before made be that. But end that. be we'll talking the shortly, – that Bausch this unless There the having to has of have resubmitted. the reason in is end with rather quicker approved decision or the we'll of the of a will And been have summer August. about – end via Beginning now will those and August be than NDA we'll be – start to the

to ongoing of the we again, to we'll to a partners So their be over plans they're of that'll couple outside next But North talk but be that about anticipate good months. very going them have America.

Serge Belanger

Okay. a on Tom, CLS-AX. And – guess I question then for on

here? of months do four something six think possible? long based see as durability models, I your as to kind possible? As increase just on Could you so preclinical talked the Or durability, is what that's you that here, is something dosing levels we you guess about

Thomas Ciulla

Great question. Thanks for the question.

reasons, for because in space, we we that visual into administered So don't the drug migration into durability. to attractively so particle expect just for But axis. compartmentalizing really suprachoroidally or all we're the of is feel CLS-AX safety not have suprachoroidal several first differentiated the vitreous

more efficacious clinical other studies therapies suggest we And So VEGFX the many to aspect benefit. models differentiates receptor, from This further leakage. there's that because efficacious therapies potential for segment in maybe more Number anti-VEGF-A from which the pan-VEGF many pan-VEGF a third, two, durability, inhibition long controls respect acting we focused current think to our to be and acuity potential respect both drying. and think has levels that anti-VEGF-A preclinical months, and with this know even then the preclinical have on are long of therapies that inhibition and/or safety early it above ICXX posterior months can really than VEGF-A. visual we for acting we with the angiogenesis

So also to can safety answer we profile – for efficacy potential good that we beyond nice question, have your inhibitor. but a months yes, have we to also four very a durability, think to may there's three potential of enhanced have being pan-VEGF and

Serge Belanger

Thanks. Look month. data forward next seeing Okay. the to

Operator

Wolleben Your Securities. next Instructions] Jon [Operator question is from JMP from

open. line is Your

Jonathan Wolleben

congrats Hey. on question and progress. Thanks for taking the the

Just for a couple me.

that the patient? see you're think what with before you when could left dosing July start First with and I second could CLS-AX to else the ahead said wait sooner I dosing. happen you wonder [sign-off we on] dose, wondering I'm going any till start that going to this cohort? from to X.X is if milligram data

George Lasezkay

the Well, thanks question. for

to the data, monitoring have patient committee, we it safety So I once we’ll visits and data the planned review the the by reviewed report cohort. first completed, mentioned, are as final from

plan to that in expect be that, June. then And We enrollment. to after we start

So we cohort potentially the could six readout that. have for after months second

recruited well. very study the extremely remind robustly. the during So the think I has season pandemic, and investigators very want eager we've we during trial gone started also the I everybody this to recruit. holiday Operationally, And have to been

about very are mentioned, I investigators the recruiting. about the as and program So enthusiastic

we expect recruitment we be to geared safety that So from but to again, the data have thereafter mostly for begin towards in hope first going the readout cohort X. to first cohort in it's June. And cohort, shortly

Jonathan Wolleben

And CLS-AX might the after? with detail discussing That’s work But data. if helpful. versus more publicly integrins which And I think there? DR DME opportunity into expanding going those then then you you've be or I you'd be think said I'm wondering inhibitors, are you indications. any just in how when characterized you completing then this integrin you about with And that year. the think And preclinical mentioned, those

Thomas Ciulla

the take And let beta inhibitor X questions integrin alpha beta retinopathy in diabetic are edema, and in discuss X, two v AMD. these that the this and adopted macular alpha disclosure. targets X X. been we that implicated But I'll alpha diabetic v integrins George latter key integrins have beta

there's early integrin know, inhibitors clinical these data large you for been suggesting and disorders. a in preclinical As role

integrin that we And our distribution the a ocular share pharmacokinetics. doing We're So hope sometime small suspension. preclinical molecule testing we're further currently this to tolerability to formulating inhibitors as assess year. in

in defer of CLS-AX. George that In in with planning, it to terms of how fits terms I'll portfolio

George Lasezkay

Well, have think, shots Jon, goal. I never can you on enough

we an to have take could to integrin diseases. another like that point But at have something looking think of different diversify so shot our trying retinal to that after your you we're similar diseases, – some pipeline we're on major go as opportunity And based well CLS-AX a to And molecule. on formulate or insoluble. with just those we there's be – it us our development relatively of think small else. to sweet as that makes molecule as and suspensions It's research are anything we small a mechanism in of to sense perfect spot action molecules able integrin consider

we're that both discussions when where And both Tom CLS-AX, end And constant indications of for products, have potential for integrin. it's and doesn't about up. talking opportunity going that's us. other and now to these so kinds I we're these another applications about of mean

we're up. it initially be where looking, we So but this may not end is where

to robust have on And terms preclinical be of about to hoping some Tom discussions that before the year-end data pretty in as able to disclose we And integrin. mentioned, the have we're the data, in so some company. preclinical

Jonathan Wolleben

Perfect.

for Looking taking forward to again it. Thanks questions. the

George Lasezkay

Sure. Thank you.

Operator

Mr. this at for I turn conference question to George further no Lasezkay time. remarks. CEO, showing back closing would to the like I'm

George Lasezkay

Thanks. this Clearside in We interest look forward for on Operator, us Well, you year. again rest appreciate doing, afternoon. what updating really all of disconnect on are everybody the of continued joining your the call. thank the now participating. throughout thanks you for call the And and and progress may you we to our we

Operator

Thank Ladies and gentlemen, you a day. this participation for concludes wonderful today's have your call. and conference

Clearside Biomedical (CLSD) 18 May 212021 Q1 Earnings call transcript