CLSD - Earnings call transcript Q3 2017 | Clearside Biomedical, Inc.

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Operator

Good morning, ladies and gentlemen and welcome to the Clearside Biomedical Third Quarter 2017 Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] I would now like to turn the call over to your host for today’s conference Mr. Steve Kilmer, Investor Relations for Clearside Biomedical. ahead. go Please

Stephen Kilmer

morning, Good thank for you Thanks, everyone, us. joining Operator. and

forward-looking by Various from to I Act be results that statements. expectations, our make as various plans for the begin, the statements other to company’s factors, on database we statements Reform constitute purposes which XX, result a important about make SEC, remind those this making be SEC that differ we risk these call during may would from filings XX-K forward-looking time the December can including of and will Before Edgar Litigation future the at we in accessed XXXX of www.sec.gov Actual like you the factors of those with the Securities we indicated the time. XXXX. with call, during and certain materially the Form forward-looking annual prospects, and discussed remarks year ended section for filed of report on today’s Private

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

elect forward-looking some point, to be any subsequent relied statements specifically our as While update representing future views change. obligation we to if of do date disclaim statements at any our even should not to we so, today. views may forward-looking these These upon as

With President now White, Beckman, over Financial On Richard Scientific Chief the Medical and Officer; Chief call I’ll our turn to Our Officer; Chief and Noronha, Officer; Charlie our said, call today Daniel are our Daniel. Officer. Glen Clearside Executive the Deignan, Chief representing that Dr.

Daniel White

call us thank for joining everyone today. Steve. you you, for Good morning, and Thank all the

complication. restore of the retina for highlight diseases focus company’s to eye; Clearside choroid those are elegant For preserve to affecting especially Clearside to like resulting story, Biomedical the Edema vision. and take diseases the were the precise on mission. is solutions our treatments a and transformative We Macular moment to developing I’d new as of benefit who

more acetonide, drug proprietary suprachoroidal SCS Our Edema or characterized the sight disease of of brief like currently more effectively than and clinical We days proprietary believe like into microinjector routes with suprachoroidal the or using tissue effectively to we eye. administration. the drug to Macular stand than I’d more XX where programs. update space diseases for Accordingly are the well to RVO, begin space CLS-TA with - access threatening bioavailability Diabetic DME or development less access our eye, the in of last SCS may using Occlusion exclusive with our the lead traditional Vein technology the Retinal treat the can effects triamcinolone by corticosteroid; of the retina instance program and leveraging injected injection clinicians treat provide a is can we suprachoroidal uveitis, side greater choroid.

will three, trial. is Later I’m large trials. patients clinical to very XXX injections awareness the treatment. any team who are CLS-TA Given clinical Phase be we procedure and getting dive our our from multiple as that treatment or studies, our adverse into in received outcomes one of minimum are undertaking X clinical continue the clinical the we any our of to events deeper enrolled now and Phase serious proud discontinuations initiating investigators currently our in supportive and X of procedural programs X study Rick have Phase over led Glen and

CLS-TA PEACHTREE approximately associated one-third suspension a world’s and we program loss enrolment leading the with trial. problem Patient first in triamcinolone X with start our with inflammatory is uveitis is At occurs non-infectious these contributor CLS-TA, over testing results late affecting well let’s months to Uveitis trial in expect we non-infectious Edema proprietary August treatment. has PEACHTREE six conditions Macular of Accordingly, Macular initial Phase uveitis of the the cases, So, as of most in our quarter alone, the corticosteroid is report all eye of completed uveitis. pivotal of to in follow-up of as treatment the patients. in XXXX. acetonide. a for set XXX,XXX suprachoroidal U.S. the the in formulation the top-line stage blindness. the Non-infectious is impairment trial Edema vision from XXXX, currently first causes after the advanced and the and vision administration dominant

used Retinal Vein suprachoroidal advanced trade the second afilbercept name Our CLS-TA is Eylea most for Occlusion. together administered intravitreal with of program treatment

superior objective monthly patients. that intravitreal to with visual a to acuity which compared newly Eylea, RVO CLS-TA show is a it’s as outcome injections together diagnosed Eylea suprachoroidal Our alone used

treatment we one approved therapies. RVO that potential that we to continuing in to vascular of the and strong approaches clinical which a currently both X than are durable vision To in impairment loss, late As permanent was trial is lead of to aggressive quarter new more most first strong and end, need retinal effective initiated the that XXXX. Phase SAPPHIRE diseases can there experience patients develop enrolment are the vision of

along masked, enrolment used X We Suprachoroidal treatment the We’re TOPAZ. controlled anti-VEGF making patient preparation initiate XXXX. CLS-TA TOPAZ anticipated quarter in in for second also first clinical to Phase the a with of the agent first the RVO. trial randomized, in of multicenter, trial

loss of of most in is for vision that for of us if part programs in XX% to approximately Edema the diabetes or years XX% untreated, DME. people mellitus. our XX vision another laid these common condition, the to expand also RVO retinal effects more, groundwork had diabetes have experience development has cause will Macular XX% to and for It moderate include vascular people who patients in Diabetic CLS-TA DME work with loss. the Our or

in had by that still in for treatment diagnosed agents, patients six XX% we’re more particular I’ll enrolment the with the the high Rick? announce choroid associated the Patient exploratory months. an over that unmet can results X caused in intravitreal diabetes current be VEGF care X, DME Suprachoroidal intravitreal second believe patient are pipeline. of been which We as couple Beckman, Eylea is in with the our lead treating issue CMO in pathways, HULK, clinical release With a significant soon up AAO for enrolment HULK with present completion at quarter corticosteroids six in newly have inhibitors is we eye administering and and effective believe of patients even because trial DME. open this we call this treatment While details and intravitreal need those DME X response XXXX, by to as practical suprachoroidal trial CLS-TA follow months use amount, we to complication through up Orleans. turn in also that label press there patient of preliminary are approximately pleased as And, anti-VEGF we’ll standard to the have for monthly the after CLS-TA announced of those repeated access insufficient outcomes presented. with has In Phase started anticipate discussion both of in Phase large A injections the our anti-VEGF retinal is ago, we’ll now for treatment. DME to from agents to DME. of the showing multicenter Rick with of improve inhibitor, and update TYBEE New completion and weeks multiple in of Study DME together without intravitreal or depth called Friday patients population. of We to data TYBEE. of the anti-VEGF

Richard Beckman

you, Thank Daniel.

given. Edema of readout and trial and the follow-up will uveitis, months trial. after visual The of non-infectious would patients treatment Phase we our expected filling our controlled of briefly trial Phase patients comment have In from of Dogwood the injected X safety is treatment. to with also observed randomized has we Macular the far visual suprachoroidal across clinical required uveitis. from suprachoroidal study two-arm be the in opportunity to to to be no with non-infectious six two the our With treatment all treatment uveitis pivotal portion Edema emerged feedback new that’s only the the comparison this I X CLS-TA corrected Based outcome details This the primary with of trial baseline arms our reported drug of acuity Phase Phase arm that who safety acuity. This a initial improvements with trial between best mass non-infectious and occasion I in support of of of improvement believe everyone on potential would trial the previously XXXX. Phase the to to in first testing CLS-TA FDA, the preliminary evaluate Macular like the the X PEACHTREE X meeting refresh Macular line trials. milligrams application. end take ongoing X Edema share on multicenter of three of in from of in to the patients compares suprachoroidal pivotal best both X significant suprachoroidal completed month to on statistically arm profile the quarter a the so received clinical associated like CLS-TA of trial showing where will efficacy that with CLS-TA corrected data is PEACHTREE associated for

subjects drug be clinical data have have studies, drug and Since related the be before the procedure. considered in to that have sometime As has the trial a to been been serious Daniel or can injection procedures more more either injection events ongoing trials well safety or provide detail have completed masked, adverse basis mentioned, had to of Furthermore, XXX the it event. on from adverse no treated our Up-to-date on front. procedure been will the so in than patients and that discontinue tolerated. it our no of there studies have to far been related drug any

profile that, and to Clearside’s trials to However, programs. observed I will continue we RVO safety to the studies moving pivotal over With turn in the forward. of remain will course DME the optimistic the early the that phase Glen discuss call

Glen Noronha

Rich. you, Thank

intravitreal CLS-TA have in can as As non-infectious detailed addition of Edema a RVO each as agents of provides Eylea used have combination whether Daniel administration evidence compared advantages Eylea acuity, treatment monotherapy intravitreal therapy that and suprachoroidal as and CLS-TA RVO, the alone. when patient and reduced Macular with to anti-VEGF in our with to along improved corticosteroids use suprachoroidal literature are visual known intravitreal. In provide medical The we exploring frequency Rick uveitis. treatment reduced

combination auto double, for approximately will on investigational XXX which patients We is randomized, sites arm called study the control multi-country of diabetic with a multicenter, SAPPHIRE arm alone. potential which initiated equal CLS-TA intravitreal baseline That to X SAPPHIRE of early together greater in treatment. Patients acuity, patients countries. the This Eylea, first in receive ETDRS of from intravitreal retinopathy conducted approximately XX of Eylea RVO. controlled, will across eight patients treatment Phase determine at with randomized masked, trial weeks suprachoroidal primary each will improvement at to or best they proportion trial letters after visual our with corrected treatment clinical being have or trial than due is be the the to objective XX receive initial

a of a and treatments the previously XX% after XX patients basis on at the letter in suprachoroidal of were Phase achieved equal with additional would injection where Eylea needed As of BCVA with randomization, patients intravitreal in injection eight CLS-TA at than naive to X as baseline reported treatment ETDRS reference point receive along an an initial improvement weeks. TANZANITE greater of RVO, trial or

the trial. in press an of weeks. than of greater the XX% Macular the X.XXX were along mentioned intravitreal seen observation Eylea XX% the the at monetherapy improvements with had in baseline is months from of letter XX at a to month Eylea expected through showed to in release Further, patients fewer results acuity first intravitreal quarter in aggregate compared are earlier Phase ETDRS one The or XXXX. of Eylea as a and and X in period SAPPHIRE improvement Preliminary with received suprachoroidal at enrolling visual study the seen eight significant improvement maintained combination three this value with injection only of While additional and BCVA treatments equal today. of CLS-TA Eylea trial, Edema an

In treat TOPAZ also in we’re mentioned, patient Phase quarter DME our Daniel As of I the to major want the study X second are first on to attention plan our first which turn enrolling to now And, retinal RVO in vascular planning we seeking in program. enrolment the suprachoroidal condition other XXXX. April patients DME where we trial, clinical patient completed without with program, HULK this was Phase CLS-TA year. this are our we the DME. our X clinical ongoing we or X, In in have third intravitreal and have trial an with trial; Eylea evaluating

While changes in safety we’ll period. in also Macular Edema this the in Initial outcome be visual the corrected the open suggest best toward label primary over combination with results is study, particularly causing from efficacy evaluation on. six-month durability and acuity treatment trend evaluating

the with enrolment intravitreal intravitreal to for a a TYBEE with portion the have CLS-TA we on the this Daniel compared in a six-month from CLS-TA evaluate suprachoroidal upcoming evaluation trial named one-to-one fixed HULK first in next to or As Eylea. and preliminary masked, a with multicenter, to assigned Annual three at results with needed be for this to mentioned, the trial expect report as over The Daniel Eylea of Further will in this control Meeting In months. trial, period. and starting October mentioned in monotherapy announced by Phase American of suprachoroidal to a DME X controlled this combination patients patient we with arm Phase will portion Eylea fashion Friday. an Academy intravitreal year, DME completion months trial patients intravitreal only along as randomized, Ophthalmology X followed treatment three

to will the primary best be monotherapy up is the will in trial While six efficacy safety acuity TYBEE follow treatment corrected evaluated combination this Patient and data. outcome be visual trial, in the data compared where will measure months. be the

Our Charlie, our I’ll third development introductive Officer, their results. we XXXX really efforts. busy XXXX appreciate had call in Charlie? all to the and quarter have a quarter over to teams turn of Chief third financial now review Financial our

Charles Deignan

Thanks, Glen.

this in We R&D for compared research and As QX XXXX. development mentioned programs cost reported call the and associated that XXXX, clinical with on our same were in RVO expected. our $XX.X in uveitis, $X.X expenses million increase for we morning, was period to development million QX DME an

remarks and Rick, their opening Daniel, today. As Glen in highlighted

in administrative respectively. our Phase the quarter We The the pattern patient in of Phase patients DME the non-infectious enrolment and development compared marketing XXXX trial primarily third in expenses initiation related of for have related of continuing X costs, preparations which a the in programs for of April in third Phase second third quarter. trial study and for trial was study $X.X XXXX year-over-year in been X XXXX our enrolment X X million, the the advancing to unchanged Phase employee to of of uveitis $X.X Phase both X, completion trial cost. and The in were RVO, completion continued X October enrolment RVO higher with and for General expenses quarter. increase is from million due last quarter and

and to period Cash $X.X activities use operating loss net the or quarter XXXX. share, The $X.XX for the compared XXXX million. share third per was third same $XX.X quarter was $XX.X million approximately per in $X.XX million or for

equivalents September fund with the it’s which operations XXXX. in million I’ll to for closing believe to back XX, over Daniel? turn And, into sufficient short-term investments totaled call cash to As the we that, $XX.X Daniel quarter fourth of his continue remarks. of

Daniel White

Thank you, for Charlie. today. our This prepared concludes remarks

made the to of call during to the open we’ve significant quarter Clearside thanks XXXX. progress like entire team express I my to for the I’d Before third questions, the

capable up for our we have their now to team mission. and strong questions. With professionals our a of will consistently appreciate delivered Operator? highly have the We goals we key call and on open commitment that that,

Operator

Boris Cowen. comes from [Operator the line Instructions] with question of Peaker of Our first

is line open. Your

Boris Peaker

congratulations on making studies. morning in multiple Good progress and

Daniel White

Morris. Thanks

Boris Peaker

is stronger PEACHTREE And, the you the follow of signal good consider just minimal would that So, my six question commercial up enough if months you on holds you end study I’m expect the up trial, would perspective? and arms? Dogwood and or the what data curious, the call longer for the drug think the from regulatory between to that placebo mean, primary to the point a first with I signal the kind is success,

Daniel White

Beckman I’ll that he’s Rick And, the the our leading team answer let in for question, uveitis. Thanks Boris.

Richard Beckman

that the differentiation a earlier both based study evaluations done was out the achieved study community significance control this was be and there treatment the because if and that also on some looking on never when arm So, will before. designed statistical the arm, and is between were our to those compare that in done has

is we and based best the we is have to a Our saying the it is that of important about going show group results that. the placebo best think way The powered that difference study, its likelihood people something the high are that but from group on the not study can there achieve that Dogwood that’s Dogwood anticipation between - exact treatment really the that the XX% adequately in and difference really point. to number study, is is we talk

to The important process in adequately in Edema that that. will we it’s the point might placebo powered to that. any show very further with on Glen that show if are feel a difference that disease corticosteroids the he and very Macular based arm that fact able this would has help we is I treating confident successful be between comments ask been

Glen Noronha

you, Rick. Thank

quickly doing, is are particular is point meeting for key study. the end goal what I post we - described the primary regulatory the Rick key think end had this regulatory point

Boris Peaker

just I it’s is to since minimally market think What - drug? - but do as understand this commercially to want control get you signal about thing drug, required from months one the to perspective, commercial the understand the six just of at I what placebo,

Glen Noronha

greater change the XX% studies significant. we that in look There achieve the And, reduction of And, from medical a in clinically XX% uveitis Dogwood shown which at, in consider from analysis XX% by have a than publication this they study in least at the scientific on are Edema was mass of study. prior established over as to based is Macular things XX% our the one two Edema. experts literature patients

So, the our same to majority we done for in in be in the of this patients this have well expect quite studies, we study. true always particular

had they and prior at Again letters. more lines, physicians XX more And, is, well higher if doing one that X letters most two at done improvement. at letter thing than while two practicing of FDA lines better second at look bar, and our than more one line, people look improvement, always significantly than than The don’t looks XX we that. than have in we’ve XX% studies, you greater look

So, reductions I Macular in think and people who disease. Macular I this and significant doing associate considered this both think that uveitis both are Edema treating physicians, clinically yardsticks used of the in those helpful practice are will be with what’s Edema retinal practices by

A –Daniel White

other I Beckman, One make one to - comment. Dr. want comment other

end primary the So, is where important safety and but we is of will terms efficacy our is, important believe also point in commercialization our profile. in that’s that very the effort commercialization be

that study very early that use. commercially going that And, establish we there. for what’s elevations a with what’s them effect disease. And, we addition and Edema, eye intraocular is currently profile is There the problem than safety treating corticosteroid cataracts to we viable out this suggests associated trend product. Our steroids is believe pressure efficacy limit and side make their the the in the to as is safety so available being better Macular towards well work very a that profile for our know

Boris Peaker

duplicates that studies centres purposes? comments. as enrol last TOPAZ simply and specific than faster was are TOPAZ of secure additional question just existing the just SAPPHIRE to SAPPHIRE for SAPPHIRE my thanks is leverage RVO. other scratch? - between there is the regulatory in of enrolled And, And, for Great, they’re each from part differences or also curious, can I

Daniel White

question. great a that’s So,

Let tackle some of me that try question. to

into how we regarding So, some are the just discussions going TOPAZ, make we most having can the with the marketplace. FDA label of the

and the predicted predict we would to SAPPHIRE. do commercial duplicate not can to, be will I label we what a look achieve best to possible for So, that. of we We get can study TOPAZ

last couple been So, in around we’ve of that’s TOPAZ. doing the months what

TOPAZ going, site? we well well. have the to as second question United procedure Your where can protocol pleased way with and we predicted we open sites the accepted States continue, have can will I’m as as enrolment as was, we extraordinarily we so I leverage leverage that’s continue been sides this that think we and outside into

Boris Peaker

for Great, questions. thanks again my taking

Daniel White

Sure.

Operator

Anupam is JPMorgan. Our next from question with Rama

is line open. Your

Unidentified Analyst

and its week guys, taking can Thanks. Thanks sort of this from Eric for data the Eylea the help as would viewed to just in morning. study, what over the in Hey acuity I find guess data for went the visual expectations control initial be the ahead us the HULK looking maybe this what Anupam it arm [indiscernible]? you in release question. dealt way AAO

Daniel White

much Great, Eric, so thank you for that.

study the what on let we there. me Let share HULK predict Glen comment and to

Glen Noronha

open not the particular was a Eylea be label study, for be head-to-head will Wykoff. study long studies trial data Thank to see you, label get able Wykoff are was seeing on encouraging late of within Charlie and kind of be and designed which an saw in some We really HULK of data. us on durability is in the open are to will of kinds Eylea. able we for in treatment those not the The make in control Friday with well presenting the coming powered, output, will control, us output be was The control it’s The comparison, Daniel. to detailed that’s study preliminary where naive trial against in treatment not the by patients. afternoon Charlie out to how study was Eric, combination that to going encouraging intravitreal data be information. that efficacy data the as encouraging. highly as you TYBEE lasted terms so

Unidentified Analyst

to you for suggestion, patient NDA kind order prior Boris’s walk first submission? getting of I that assuming and positive is or a FDA to looking to of exposure maybe follow of to - for of there terms need Thanks. maybe us quarter, through product in Got data thanks anything walk guess kind just on follow up regarding factors particular clarifying, thereafter, it, falling up in in question the through

Daniel White

this let with Right, well, he��s this one FDA the as Glen Daniel. that answer project. on is I’ll been dealing

Glen Noronha

agreement with our our outside earlier be X, terms X, FDA Phase and from of X So, that required the than the things more submission. have data our is of complete for Phase exposures, the far whole XXX that that we’ll trial, gamut NDA we’ll the in safety, PEACHTREE of are submitting

Daniel White

Eric, this Daniel is again.

So, want that you I just to about remind trial.

the trial to looking first immune with Macular Macular treatment, in this we study auto have And, an have have where with no Macular non-infectious they treatment three gain are best in the have Edema ability patients that resulting no uveitis at clinical Edema condition comparing we study, Edema. So, control. given we the is severe treatment arm. very that in that corrected compared that would lines, visual acuity so are who And, to

see that. we injections. is So, them that look gives taken that further about these had the we’ve non-infectious uveitis to particular too it over risk in XXX have multiple much that that opportunity - us in visibility injections we of see an we’ve and look What out trial patients patients, it’s injections, this in early But HULK at us all most exciting possible been study. of of some multiple referred multiple gives at in HULK, the

the been across to data sometime further hopefully seen reached the think position be have indications in we an and use it’s multiple triamcinolone show in XXXX. the that begin has to consistent the process and of working first procedure I great late we’ll a filing is and post quarter achievement So, of cleaning the up we that in think

Unidentified Analyst

the Great, that’s taking very helpful. Thanks question. for

Daniel White

you. Thank

Operator

the Company. question Serge our line from Needham & with Belanger And, of comes next

Your open. is line

Serge Belanger

questions. Hi, good for morning. taking Thanks

the DME, reports pivotal XXXX. two on the At and the one First, this you point, RVO TYBEE guess, expect end you this then terms kind in do week, later of in second whole points trial program of trial the the studies? have and I the done of what quarter see, in to mere DME we’ll so results

Daniel White

the for question. thanks yes, So,

in TYBEE, combination in anti-VEGF comparing suprachoroidal are the comparing we triamcinolone Eylea we monthly the compared TYBEE. with So, are like of injections to Eylea intravitreal,

suprachoroidal So, are there’s we Eylea that we looking looking have we what see time. of with over and can early What you long-term. we that verse In triamcinolone. believe better we and comparing at difference triamcinolone foundation the we what in find comparing outcomes between the the if at suprachoroidal were TANZANITE, hope treatments TANZANITE reducing TANZANITE. outcomes patients, acuity we TYBEE, way better and that best intravitreal can early TANZANITE of outcomes, quite we in the period that corrected on number visual we But comparing that these did are the and see of improve

the So, with - on turn anticipate might what let that, look I’ll it Glen outcomes it comment of kind to to to we as relates over to like. TYBEE, specifically

Glen Noronha

what for months best out, how an to for two three are DME And, what studies, optimize years kinds data usually in show long done, of studies care. so from that year-long had best pointed types of and Daniel DME advantage will view a and can be registration RVO, point approach we the long really as are and both usually studies you, studies there efficacy. data let studies of are are for of Thank efficacy, Daniel. even the will unfold in six The provide that so And, fundamental we patient difference get are we is from you different our we can doing doing we the dictated treatment in can our safety, will how of they whereas will have by different our the that safety different inform what RVO terms logistical plans are see data be diseases. how will which for years

Serge Belanger

from the Okay, and HULK then besides trial AAO. results at

on data additional any presenting programs? You are other from planning

Daniel White

the So, thanks question. for

bricks]? we information We and hearing that our great, are it, plan plan but can let planning highlight places are but of [high maybe in Beckman information on I about on using it, Rick seeing the talk not other some couple a delivering KOLs to talks. hopefully we are folks other we’re the but of many where

Richard Beckman

know will clinical Leaders talking I some going one will at meeting Ham bit of know our Saturday. going that a [ph] that to of. to And, Thursday. I about be that’s Cummins meeting is day Dr. ongoing update, to OIS except know going Friday, TYBEE he’ll on of data ones discussed the information Duble TYBEE talking little programs, excuse HULK. Key be a going the who that TYBEE, study head Duble the our by on is Those [ph] be no the So, OIS a going to is discussed I new the little be yearly is I of that but on this are be also also not particular to bit data and for Opinion during believe Dr. doing about who be our Subspecialty be me, the is address the

Serge Belanger

All right, question. thanks the for

Operator

showing I’m right, All Instructions] [Operator not further any questions.

Daniel White

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

Operator

this the conclude Ladies program. does and gentlemen,

great disconnect. now Everyone may have a day. You

Clearside Biomedical (CLSD) 8 Nov 172017 Q3 Earnings call transcript