CLSD - Earnings call transcript Q4 2021 | Clearside Biomedical, Inc.

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Operator

Good day. Thank you for standing by. Welcome to the Clearside Biomedical Fourth Quarter 2021 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-Answer session. is host to Clearside today, Relations. it over the Biomedical Now, your to Jenny Instructions] my hand pleasure conference Investor [Operator Kobin, with you, Thank ahead. go please

Jenny Kobin

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

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

that our We tomorrow. ended XXXX filed XX-K XX, year expect be will for the December

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

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

George Lasezkay

leader first our Last achieved Clearside of quarter, suprachoroidal validation Jenny. the XIPERE, our in you, a our XXXX with injection delivering drugs platform. the Thank space. approval solidified into as and which suprachoroidal position we for was FDA year

site edema therapeutic of patients in access the U.S. make SCS of commercial uveitis. of this in Microinjector. to battling Lomb confident is to United proprietary directly in capabilities treating that this potentially respected they the approach in the difference first is and the partner a macular the the We retinal have of advance a lives target industry, eye associated last being Bausch with is XIPERE Bausch to innovative treatment in with our Bausch team of well and the in we're month for these the commercialized use + diseases of XIPERE announced honored back approved the focused have condition. our by indication patients and their a developed leader disease. for in truly XIPERE launched training physician the therapy strength allows blinding in States need. therapy to to our this that unparalleled we're

New commercialize commercialization with development Zealand, brand in edema trial associated regions their of Last name our initiated Vision, Arctic Australia, XX make their countries. which Phase ARVNXXX South X refer China, to as great if XIPERE, Asian uveitis. and Arcatus. confirmatory in greater China-based quarter, ultimate licensed Vision strides XXXX, Arcatus, India, to During macular goal is they in China approved also partner and Korea, Their the and Southeast with Arctic

our to edema. for of in In Arctic first the our a XX have the will the Vision ARVNXXX Arctic XIPERE trial announced China that clinical related dosed and and we funding of of total, The balance week, internal X Bausch million quarter treatment last addition they patient Phase utilized non-dilutive fourth advance generated Vision be sheet. programs. macular pipeline our milestones In in also strengthened that in from diabetic

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candidate product proprietary Microinjector. positive and track endpoints suspension, OASIS results achieved delivery in dose reported our pipeline serious this primary our X in data Cohort AMD. we XXXX, from internal in with we've In CLS-AX lead X.X Phase with cohort Cohorts CLS-AX from our small mg first kinase with remain midyear. was at combines events, safety Our making X/Xa by with of molecule SCS wet in and X these we inhibitor tolerated X progress and adverse the a axitinib no We X to patients tyrosine Cohorts on our report well CLS-AX, are trial

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our I trial recruiting study highlight the also Phase of this their We larger trials. by made suprachoroidal have therapy to oncology OASIS and complete a year. expect to tremendous clinical Xb that partners gene in want clinical strides and the entire begin end

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Biosciences most in tumor utilizing to partner, conjugate choroidal adults. SCS for is viral our the drug deliver intraocular oncology melanoma, of AU-XXX common Microinjector treatment light Aura ophthalmology Our their the

our more expect data potential to data current treating year. vectors. non-viral are presented therapy with an potential suprachoroidal about use preclinical Today, disease suprachoroidal our our and advance several treatment be a to rapidly. programs approach promising remains ocular will Microinjector proprietary both our gene the promising expertise retinal later this therapy we of clinical noninvasive of excited offers We trials gene a gene have platform in-office these to the and we disclose companies their and in on the viral therapy and able to and Aura approach position indications strategic the commercialization published of therapy, therapy. We from programs, injection for Gene keeping gene with believe constructs, deliver suprachoroidal potential the non-viral therapy or partners -- additional diseases. disorders of in variety to procedure working for on our SCS more through to decided specific programs extremely that Therefore, using Medical to other turn provide and viral our small with data retinal such licensed around as over are current that specific development or companies detail any therapies partner Ciulla, Chief to and vectors that anti-VEGF atrophy. have now retinal inherited more for Outside discuss partners. the of REGENXBIO, vectors Officer Development Dr. focused we care targeting Tom consider diseases will molecule Chief a with gene geographic disclosed the I Tom. treated suspensions, on clinical not of disorder call are development by Officer to we for standard retinal primarily our

Dr. Thomas Ciulla

innovative a being space Thank physician, to therapeutics for and the the our and of delivered the extensive U.S. to the injected edema and blinding multiple and in working administration. like approval for delivered pre-clinical on part delivery SCS beginning. indications. training models unprecedented very patients have our is support suprachoroidal product Microinjector. XIPERE first potentially retina afternoon, as educating for space. suprachoroidal their is forefront is durable back program the just developed to with procedure closely of device and truly on for been team launch developed I associated are we've in to suspensions I'd and and that the Lomb with diseases. believe as Bausch option that of product platform retina the to the Bausch we XIPERE into specialists small you, focused approved offer first shown therapy the redefined access suprachoroidal commercial approval treatment are George, macular October, with suprachoroidal medical their the molecule retinal proud an XIPERE when in the We've Clearside therapy by uveitis, on the study from SCS This on of the serious we good this only have eye, the XIPERE, Since saying At of achieved and space, injection a FDA them to disease. suffering are accomplishment studied first developed partners sales the treatment micro everyone. + suprachoroidal and begin is

in have the the tested levels a a a in in times IC-XX, inhibitory use concentration. durable complement shown tyrosine axitinib, half respective standard In to inhibitor axitinib, kinase than maximal inhibitor describe we've vitro also addition plasma X,XXX that higher RPE-choroid-sclera drug to the at

are program made continuing suspension Our our delivery. a current steady last of for proprietary We have molecule we lead axitinib, development the XXXX. in and in formulated that our of year small asset CLS-AX efforts is suspension suprachoroidal progress

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to change one of related heavily the XX In was in in two, In patients. events there patients thickness and pressure, injections visual Cohort inflammation one, heavily five patients treatment combined prior of patient these entering treatments to although The were and combined per were retreated corrected enrolled mean anti-VEGF one post were experience entering at X, acuity dose In not mean defined patients X, retreatment best their protocol other milligram. and protocol were care did were were patient with were OASIS prior retreatment, at addition, stable re-treatment or numerous the the independent cohorts. no Two At of OASIS a based center adverse month one trial. was standard macula of any and X score met not reading vasculitis. were inter require central retreated on defined dosing, criteria. the in retreated to criteria Cohorts assessment, experience three subfield All treatment month trial. patient X.X at the three ocular enrolled and CLS-AX months all

retreated part particular, total retreatment, promising dosing or post without one at of the XX% retreatment. at went in of In patients total XX% CLS-AX the patient of of months four least also of durability saw or We month early Six months two the without three X% this was total when one. study. signs and or the patients

we've mentioned, of trial. progress George Cohort As the made with X

kinase established based in report reading results for are reminder, tyrosine criteria with experience we've Cohort or to X stringent protocol we track active trials, AMD confirmation. remain treatment center inhibitors, We a assessing ongoing in patients enrollment. disease enrolling from on the As patient Unlike on midyear. our only wet similar space TKI

no of scientific range trial. also to Phase add combined in X doses was to Prior from Cohort we to This forward broad safety plan dose We we X. advisors data X. higher based plan with evaluate a with decision a with one toxicities, Cohort Cohort X dose toxicities Cohort and input see positive to clinical moving in results on limiting preliminary explore X the we'll review from in the to safety Xb a X, limiting Unless Cohorts and dose. higher month dose at the our initiate

data review Cohort and year, X occur X this this of expect X and We of and quarter to overlap. in initiation therefore second the Cohort

of inhibitor that processes inhibition utilizing Integrin patients referring we We of are potentially targeting, planning suspension. by suprachoroidal observed play service inflammation, we've macular such role adjunctive therapy opening what delivery X in edema, diabetic Xb and as durability inhibition Integrin We other expect to ocular from targeting in molecule year. are suspension, therapy, inhibitor of diabetic Cohort We Integrin program, and enrollment molecule a macular are tolerability, endocrine pharmacokinetics which a provide similar small Therefore, to play for the may and in topical end we individual diseasesincluding of refractory the data that macular inhibitor of we clinical pathogenic this the administration secondary trial, cases delivery, therapy could begun an fibrosis. a on and suprachoroidal studies treatment year. assessing could believe angiogenesis advantages of role anti-VEGF to small CLS-XXX. also We've distribution later to an report macular degenerate. certain Phase to working our suspensions. trial degeneration. for primary compartmentalization, We've Integrin the another been of Suprachoroidal a preclinical and and our edema Integrin in believe or suspension

has signs tolerated with the initial data targeting is that preclinical ocular favorable retina of and initial the Our shown seen agent well distribution choroidal encouraging durability. we've

and formulation the study optimizing to preclinical start are a soon. We expected second

We of in the expect in this half the to have second year. study results

ocular only as programs. first and to states. development Both REGENXBIO have into XXXX our data our several product reported using clinically ever Biosciences Aura from start now about also treatment the presented their the safety multicenter Microinjector our gene the from and may is REGENXBIO suprachoroidal patients RGX-XXX. SCS in-office of early to oncology. year partner platform, label in of suprachoroidal with these impactful both running our REGENXBIO and the trials, but injection suprachoroidal results I'll was for for dose Moving escalation injection. the was fact gene REGENXBIO. We're with therapy offer not two randomized the open promising excited efficacy, simple one-time candidates delivery therapy delivery suprachoroidal results promising partners trials of tolerability evaluating option that a controlled deliver studies

do patients these therapy after before immunesuppressive Importantly, steroid RGX-XXX. in administration of trials or not prophylactic cortical receive

X patients interim X, RGX-XXX November of six As of continues are tolerated in XXXX. Cohort for enrollment in week, Cohort wet Last be the RGX-XXX are to and treatment to reported for AMD, X expected with was trial data the reported completed who antibody updated first ADA evaluating X and positive REGENXBIO patients the of and in X. for Cohort positive. neutralizing suprachoroidal in is delivery efficacy X the Cohorts for Enrollment Cohort well and status be ADA. in complete months at X half

of at in to months, the Enrollment on is who In addition, time severity observed. the antibody patients Cohort X% XXXX point. Cohorts the XX be at with positive no an diabetic patients two in six patients three and X is well retinopathy is patients six adverse from REGENXBIO retinopathy control. standardized conference, with data trial Suprachoroidal Cohort patients from intraocular the first X in last increase delivery in importantly, the events improvement a observational tolerated and of month Indigenous the updated X. baseline This diabetic the RGX-XXX evaluating XX% of X or to of demonstrated And was and at more from out from ALTITUDE to compared expected completed are in positive. interim serious and reported ALTITUDE the no months. for X neutralizing month inflammation XX% RGX-XXX drug-related at trial their following patients Phase scale

to first set reported suprachoroidal interim choroidal SCS cancer AU-XXX The Aura addition, utilizing our melanoma, X primary partner X ocular in delivery X, their no the treatment adverse data profile of most the adults. related common presented Biosciences Aura with In our treat for Grade safety showed or events, Microinjector. adverse data intolerability a delivered safety data toxicities via dose favorable events. serious Phase limiting

demonstrating Degeneration XX delivery, retina data year. Biosciences and very this Exudation, expect clinical We over the you small progress results. their the now our we extensive specialists suspensions momentum benefits the continued updated including REGENXBIO XXXX, presentation suprachoroidal this this for of suprachoroidal and gene delivery, potential their Aura my with clinical look entitled and methodology to suprachoroidal Last year. Charlie and engagement and financial progress featuring engage to for Aura Deignan, forward results. Palmer Angiogenesis, to injection durability suprachoroidal more to year Charlie. with keeping the We I month, its at attendance clinical therapy. XXXX intravitreal The preclinical colleagues physician later our Conference. on continue clinical suprachoroidal trials described programs. clinical data to in to educate retina as delivery review of forward our turn the community. molecule suitability the and in possible and presentation CFO, our call of current platform is a of plan and development of eight Institute advantages I'll was suprachoroidal on our and encouraging to delivered ongoing we trial congresses, look a delivered disclose from delivery clinicians at medical presentations Bascom I space The Eye

Charlie Deignan

Tom. you, Thank

our a has XIPERE’s company. George Tom mentioned, As broad had on and impact approval

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

a non-dilutive Lomb, million Our significantly $X the generated On milestones, including last total million X we in $X XIPERE total nearly approval basis recognition million of Arctic + payment. received was X, was trial the to development of progress million in our in their a XX XXXX XXXX over and we of deferred funding. cash XX from we and course From million based in December approximately a In Quarter of XXXX. of upfront the on of received received Vision, $XX strengthened $XX and Therefore revenues sheet territory. equivalence with Bausch million. XIPERE their of XXXX of XX, approximately related million and license From XXXX their related China year recorded milestones. the previously in expansion the X cash initiation cash of Phase revenue as XXXX from our approval totaled balance primarily in revenue,

earlier milestone. year remarks. the week, will from this This we the interest in pipeline all development CLS-AX. our clinical received research additional Lomb into operations well. his and active to XXXX. forward broader remain will and XXXX in of and to will over the to In call to we we we greatly healthcare XXXX, first closing approval we look planned the fund to a conferences Needham now on our million Bausch As and to not reminder, as stakeholders We participation our appreciate support second does in current suprachoroidal the as and our quarter cash the with by back our resources include advancing Cowen platform of our capital FDA led in pipeline, sufficient the spend utilized last our advance injection to the ROTH XIPERE for I on focus funding be to first upcoming George operations very our We turn XX joining this + obtain XXXX. have of from expect and Healthcare burn look forward investment community quarter related conference

George Lasezkay

you, the the Clearside space. therapies eye is Thank Charlie. through to delivery the revolutionizing the suprachoroidal of of back

and pleased joined of clinical our and delivery and collaborations. We thank the this look with has novel now, administration. numerous CLS-AX offers important the and we data clinic were there of Last announce advantages clinical initial And to support Ben look brings our well perspective Clearside progress innovative approved stop like whose board. current conjunction global injection increasingly founder retina research shareholders, Dr. patented for In space, I a strategic broad XXXX milestones an trial that has Board of OASIS year. but six accomplish utility our partners several to-date, unique first and our to commercialization pipeline Our technology. forward and drug technology needs, to year. trials us also our we partners scientific for landscape, currently our team, stakeholders throughout disease and suprachoroidal clinical our are suprachoroidal approach to types we over work we ophthalmic injections internal as helped Ben demonstrated drug we our with Fighting ongoing clinical forward advance the over of our investigators from would on major Clearside and external last a treatment expertise leadership to all the continue Clearside and In suprachoroidal our ocular additional Blindness CEO including other indications, targeting that readouts there. of this this advance our the of administration his validated and is in have week, leveraging multiple as to Directors. platform complete expect development patient Yerxa does expertise all was He he development to not and of deep Foundation closing, year,

questions. about threatening inspired the the to to to I diseases. bring now sight would additional for future and therapies ask call like to open with the We up patients operator excited are

Operator

sir. you, Thank

question-and-answer question from Instructions] Annabel begin Stifel. Your session. Samimy now will is first with the We [Operator

is line open. Your

Annabel Samimy

Hi. for question. my taking Thanks

decision Cohort add going get on this and you're point color to fourth to how to the limit. at more want upper CLS-AX, Just bit to choose a the little the

read then trial? should other duration safety? that cohort? little that into follow of Is driven would axitinib by this feedback you. efficacy question seeing that. from the a advisors, was And of just in on gotten So you're a anything [exogenic] about behind it we it decision it And the second being or in after I'll is with something you've Thank decision great? terms strictly that color So up first your be

George Lasezkay

let detail that Well, the you I'll give the the -- an on and questions think thanks you overall I'll that. X. let for behalf George. on that the asking Annabel Tom? Tom the of is we're questions, explain around to Tom in you're move Cohort this important on whole program, its We rationale and where

Dr. Thomas Ciulla

Thanks for the question.

You to much to we and we we we toxicities to haven't this. range basically Phase dose any and safety you to Since we said input the we're to while we continue into Cohort effective a do take escalation. X as need clinical explore seen advisor, fourth positive our simply consider profile Cohort alluded X X to scientific Xb, And the dose. that this given wanted to on decided brightest Phase date, of to evaluate and into Xb limiting most the doses continue as Cohorts add going the from and to dose

still toxicity based and enrolling alluded based Cohort our not information data. range IRB of patients think, supportive on preclinical And George is further, to believe to if X, conducting in Throughout We dose of that So, from believe the escalate it's and dosing there we've process an a schedule decision the there'll I I mentioned. is broader we're overlapping we room initiating on be OASIS, X. Cohort highlighted levels FDA and appropriate. as doses of as any

Annabel Samimy

as got gene pan-VEGF the AMD bit development programs of biospecific concerned. in then far Okay, is there's wet guess a I it. therapy. landscape picture wet number And of a is there in quite antibodies, just as AMD,

bifurcating for are between any appropriate pan-VEGF that -- versus So to how And break might assuming gene this VEGF is things have successful? you as down do do therapy. treatment these you market see who sense how

George Lasezkay

great with of well. major had as few if predicted these. wouldn't wet There's some treatments some asked a been commercial have ago, I years failures a AMD that's Yes, you issues question lately. me And and

because to we efficacy. it's a response show differentiated what to less we expect like So, hard Axitinib inhibition that is gene see therapy. I be potential have out for but immune potential therapies an to going pan-VEGF and very of safe biologic forward, predict it you'd molecule better has from think the there with many the and small with continue to is

think and may because potential can target months leverage tissues our have of also potentially we We these get of even eye for preclinical we some high know delivery and core potentially of the very that retinal that to safety, away studies can we rapidly the We from will features efficacy. from that effective levels suprachoroidal front enhance many further compartmentalize durability.

small think and I So, benefits. being overall a the less the action benefits not for potential pan-VEGF, delivery durability of safety targeting our immune molecule, as compartmentalization because with and only potential differentiated mechanism going forward, suprachoroidal being therapy very also for is but potential of response of course,

be used the it as it that with dose obviously patients potentially used anti-VEGF still therapy, ongoing study. out patients current And and used who be for who be therapy are established it therapy we're have could refractory sorting somewhat ultimately, could monotherapy. to escalation maintenance even as in So, as could

Annabel Samimy

And just therapy, versus that traditional a for cetera gene far et population be would is as as gene there more therapy therapy? appropriate

George Lasezkay

the and programs and because therapy Well, telling therapy I potentially criteria think, of be some of some current to somewhat the patients to are depends. treatment treatment responsive have inclusion exclusion from gene

with has better potentially consistent serve highly would there's it's that for who the somewhere So, have three to be think specialist used refractory think that for current therapy to we inefficient gene be for treatment CLS-AX efficacy, -- role, breakthrough responsive dependent. to patients a is practice. is it and current month and but the is therapy broader retina potential six therapy be our quite intervals have of mentioned there's between suprachoroidal potential durability, having I may even because the the could attractive. but We patients model ideal have durability gene a potentially pan-VEGF I undergone And role that the example. practice be which mentioned patient dosing and and adjuncted could that as therapy may as that it a patient for

Operator

Your from Wedbush. Argyrides next with question is Andreas

Your line is open.

Andreas Argyrides

Good a our have afternoon. here. Thanks questions. for taking couple I

the the to in does suggest safety maximize or And a efficacy? cohort, So a and planning, close is if then dose fifth that adding positive data getting Phase X study there start present present is the finding also lastly, the do of you're to a share you you with Thanks. design from can Xb possibility the Xb can potentially with go extension this to results? ahead Phase moment? at details you the of you And time Cohort detail, what of then same plan at

George Lasezkay

Tom.

you of think all I those take questions. can

Dr. Thomas Ciulla

Okay.

George Lasezkay

you if will, Tom, think can't, Sorry I that. you can do but I

Dr. Thomas Ciulla

Well, you about asked the I dosing. think

we broadest So, you And we even the already of started and we X. expect we've have we at want actually have meaningfully know, mentioned, possible Cohort you quite recall, escalated to doses. to X.XX.So see range And I biologic some response. if higher -- as in

or a Cohort use that would the X expect study. We Cohort or that X dosing would what in one Xb be potentially Phase we other

cohort anticipate a adding don't fifth at this point. we So,

I question plan be still X planning results the when would next design, was for your data was X, final mid-XXXX. study Phase extension trial the premature Xb in phases and little on about in that. study think the question comment release we we It'd results announce Cohort a it. And I on think to your Cohort bit extension from and to we're

Operator

Chen question H.C. is Wainwright. next Yi Your with from

open. is line Your

Unidentified Analyst

the agreements. I potential if so already? about sorry you've would shown year, but dose or And you you you this, that the of compared behalf programs + what feedback is on initial on the Bausch We And from in later I'm know with data far? do you from physicians OASIS we any And and from this potential to the conversations [Chi] study, expect quick plans? immediate Lomb, companies Are lastly, in Cohort explore have we want questions. in is with licensing contact Yi. data can much. are that question this potential so in to their feedback know educational physicians X Thank X? Cohort presentation during three your launch I your any just missed Hey, second spoke you Based discussions

George Lasezkay

do reaction on what the with on think know want comment this reaction they physicians to specifically you've intend training in in the do and roll and in and more we you had to the particular? their program first the the to training how of I what Bausch with to Bausch terms about comment done Tom, out training question

Dr. Thomas Ciulla

absolutely. question. Sure, Great

with all we've They've very trainer's nice the a goal and uveitis assisting very retina with to States. So, involved specialists the train program. been Bausch the specialists of of robust the is in program. United their program. Their + developed training Lomb They adopted development

peer program, to other specialists. it'll a retina specialist So the retina peer training, be

office. well. effective. So very feel the the in formatting administer that specialists with it's very therapies They extraordinarily suprachoroidal And positive key regionally, being went and from Clearside well these were we've and They're that sort of training. program. could feel the results. in then was was trainers they the to second sessions involved Physicians some trained your will We And the question X. positive expect of capable feel in train Cohort think, some able trainers, initial or feedback then trained. And excited gotten specialist which team from about and the quite I of retina turn of retina very the

results of format those presented be the we've similar think previously. I to what So

that's has we'll similar dose be to safety. Just the we've is and but as be, what presenting data will a reminder, single be study really sets previously. escalating focus this to presented about And what it

asked ahead. about -- I'm sorry. I think you go

Unidentified Analyst

one the No. for to I dose Tom, decided have think we was other Cohort say, going was X? I

Dr. Thomas Ciulla

we And yet. we yet. finalized It'll have be Cohort not but finalized that that not X, than have higher

Unidentified Analyst

much last one you the started already that. discussions? licensing have are you potential for agreements, And so on you Thank

George Lasezkay

a I'd would listen, we talk and and answer have one, us say, of companies contact about number interest from I that licensing. Well, potential

something we've then to REGENXBIO of we're focus also So, forward on regular Biosciences. we're therapy is but not as It it's ongoing a as going done Aura if our with said a business. go feature gene before remarks internal going therapy not our for pipeline. to that partnering going this us, to critical or in in farther something immediately is of with said strategically would that be have partner I've we that for any is part our gene

do. our that, and a discussions time-to-time, just is, than collaborations. do company tell we So, but matter you people to multiple exploring make I that all it's any more I can't not from ongoing comments possible We're would we relationships, position business in we're to have and -- can talking of like are any about except we potential people

Operator

with is Capital Partners. question from next Your Jallah ROTH Zegbeh

is line Your open.

Zegbeh Jallah

being of I'm used been in by get the a more I for the cheeky of first just much me are with the here. meaning, X, your think with saturating ask trying Cohort exposure a that's And a you X? is you ones I've Cohort higher? And think going one couple understanding really asked. achieved I get going just of could to the receptors dose that good being to lot questions

George Lasezkay

to to Tom, Well, question? want you attempt Zegbeh answer

Dr. Thomas Ciulla

add possible is may able more But we reservoir kinase the more. that and that's achieve, and to. as it to -- that aspects Obviously question. receptors you like more filling we one, has other acts provide well, we natural further But inhibition potential as states basically saturate may two reservoir, the the the a as to durability. the And great escalation No, thing of number space, three. about need aspect is -- Sure. and there's a drug suprachoroidal we think inhibit of be you but tyrosine alluded would may safety the Zegbeh, drug dose is us other to we're not escalate, the efficacy the to

it because but some tyrosine it's kinase and of efficacy to potent ultimately escalate continue can of to microgram interesting safety, more that that decay So, potential effect this assessed potency. levels as or efficacy case, in small We the potent other is And are doses part over the more the also dose and are that obviously, of been of because to we per time for we start the we the still drug also, single have of facilitate more inhibitors as and escalating v dose that as have highly escalate assessed very currently. is in durability basis. high look that a have inhibitor. being microgram on a fascinating the durability, It's study, one features at biologic the

a answer potential have with the terms potential if even to we do of So, also question, potentially greater in enhance your we durability to dose. for saturate efficacy,

Zegbeh Jallah

As to X a the to here wanting to point for profile? is some follow-up X, show this Cohort show you some kind safety where of efficacy Cohort is clean or similar just

Dr. Thomas Ciulla

X, felt there dose already subject Cohort X see response. respected sign Kaiser, profile. would a he also that response he a X. who's than a we And CSTs Cohorts recall of may extraordinarily you suggest helpful that Well, stable that of want between biologic observed us. specialists think, dose even retina of be note X at provided we well bit potentially to data and on the obviously appeared KOL show a Peter safety. We level and X thought may CSTs It the a he the because felt Cohort to was with more be safety Cohort on had had to that conference I end And and in some in web have we the and that he beginnings

would we're Xb. may and curve doses see think, we Phase dose think that more to escalate, like be we as we for in start about start helpful to which and response as signs a more that, So, we

Zegbeh Jallah

that is is said, or maybe something as being show better in show but greater to durability. maintenance with achieved to durability, Eylea, Kaiser just or ready Eylea CST even like with and longer superiority you related over to just goal mentioned Dr. the it like It slightly common that relates better of something by but maintenance to efficacy or efficacy

Dr. Thomas Ciulla

to Such hard inferences small numbers even any smaller study really Eylea. per compare and a it's make cohort, to this to

to beginnings we which us small dose should Eylea, with like to But make effect, really biologic some focus help intriguing can't such sizes of control of any and to guide to really we a think just without really comparison see the We'd safety. group. terms on I want sample it’s inferences although So, in the selection. speculate, really

Zegbeh Jallah

what kind feel at to I trying have a what that see confident trying get to need of profile. understand, with you is to guess to program differentiated I’m a you

Dr. Thomas Ciulla

Phase study that mentioned going have in to patients we're in bear think remarks, But to are in a a Xb my further refractory. as way who study. selecting I we are mind, I Well, in prepared

to the center to these months they highly are as And who to reading experience. had have prior treatment at four have have patients within have generally two And you confirmed study So, recall, are they doses entry. then activity. screening,

biologic don't treatment who respond will study patients very are reading patients There of inform Phase definition a center our think effect, patients selecting. a Xb. current confirmation be currently the And this who sub-optimally about are these in that's XX% potentially bit therapy. because of we're by other XX% almost exciting as essentially selecting to does help that what activity, refractory. represent and that So, we are if trials require we but And these -- a I see -- way, we're to could the us

then approach a is So, this it's has a think, pan-VEGF deal you molecule, for big as not molecule, recent response it's given in really know, immune yes, to question, in well-characterized And these potential addition particularly that response. durability potential the AMD have has confident we biological trials. been small immune there. who this in then treatment we're for And refractory. fact the think your are patients that a answer I the a potential may nice safety And is potential

levels published orders that As data we've IC-XX achieve rapid in the could you to know, a above showing for recently months. several six up we log model

for wet specialists and with attractive, think So quite we approach could of really who are be helpful deal this a patients and the AMD. therapy with durability this the retina the safety, very a efficacy,

Zegbeh Jallah

Thanks.

question working really then And the patient appreciative plans we're last hope I know any this was Phase you're the talking about of made you about haven't that how my So response naive it of population heavily of patient investors I then patient what because magnitude trying about here yet, as not these efficacy XB. to a population kind of population. relative to as to and and that thinking with. at or because think magnitude that's see, of refractory terms the get but high may I can are in patients be just

lead there's that be patient the go population path your what a be some better into whether things some What kind or the think naive is that should prioritizing of are you'll not that to a it the question Maybe or might as decision? size to indication setting, opportunity, decision pre can are of to market? think a the for Regarding to you make faster market treat prioritized? help that or to you going George, things be you

George Lasezkay

Well.

I think, Zegbeh.

You to consider, just have at listed all to consider. obviously the ones that to we have look have competition. we We

of look have We size at market. to

get setting a decision shot, We path going there lead a is a moon -- try go We clinical which of up have X to better through something you lot Phase around hopefully to things into go trials. forward? the Xb look are do that's for at to approved? Phase will There's that

of We're yet, but lot considering As in with factors we said, mind. not approval have we we in in Phase we’ve lots we're of finalized have ultimate the planning to Xb plan approach Xb of middle deciding now, input. different want that a Phase a how

into you've some of that's just things decide that to more that'll which important deciding factor. all account the you one mentioned, So, is be very That's be be to take sensitive one's going the which have and that. -- for you if final a comes it. make still have you can to trial anything of out -- OASIS data Tom, waiting and we're still of add conversation determination to that having the of the that

Zegbeh Jallah

And all platform. on congrats side Perfect. fire gas Yes. optionality the licensing all this have the regarding

George Lasezkay

Well, your thank you. We always support. appreciate

Operator

question Bhasin Rohit with next from Needham. is Your

Your line is open.

Rohit Bhasin

and for to action? for market are you indications doing with what then Rohit can on trials, trials about Vision In the color are the is of taking Arctic this anything Thanks the different? program, to you Serge. And question. for some regards mechanism Thanks. inhibitor the looking studies my provide Integrin this Hi,

George Lasezkay

to have but regarding am, in I than probably number He's doing closer very Arctic's Well, Tom go I'll stage could that's early still ways let we Integrin, we opportunities a forward necessarily edema, and be style, what terms comment. other some of potential we carbon carry diabetic as pursued. that thinking we of not Integrin but that think Currently, macular to could we're indications. that's have of

style carbon Tom, Arctic their not trials two So, -- time. decision that in Vision they've on well a to do that's this you defined or But that's on China? still in at that's want comment a started point been they

Dr. Thomas Ciulla

Sure.

as X also essentially macular uveitic the ocular it's calling China space the this we from ocular risk hypertension study, often hypertension. and but trial been macular I a believe in first cataract similar of because limited them. announced know They've And for of edema use a pharmacokinetic their in edema doing corticosteroid is of of the and We in potential macular a edema, so for they're can corticosteroids suprachoroidal PEACHTREE cataract underway. you to our very study, is Phase have trial, announced because believe minimize they've dosing development. a front and patient their that's diabetic trial. they're approved the patient. the of registration the it's way I dosing So, their of think compartmentalized in progression still diabetic eye and early treatment by in

the excited have about in trials. macular edema. uveitic addition a XIPERE for So, there's to very potential role in to macular edema And we're diabetic

open lots success. great with excellent We and have clinical Vision, of them. Arctic have with relationship our an biostatistician change we a dialogue relationship. And wish them It's

George Lasezkay

very the we're so, they working Tom Vision, their terrific aggressive happy what about of engaged them. territories. call appropriately echo and and they than very be potential I XIPERE said just I'll think And Arcatus a They're in Arctic see very they've but been with partner to

terrific been we New very been with, Australian, in -- partner And happy just They've they've Asia, Zealand have region. work to wonderful that. think, really overall the a so, I about

Operator

is And Securities. from Jon with Wolleben JMP your last

line open. Your is

JonWolleben

million should might remember for look year? talked Just two expansion and with for any also royalties you I then what this first is right, Phase expect the if the XXX wondering AMB, meaningful we but royalty Xb If free. me, and about CLS-AX wet indications wondering the other XIPERE And like?

Thanks. that for this confirm to expectations for hope Just year.

George Lasezkay

to Thanks, question the John. take want first? Charlie, royalty you

Charlie Deignan

Yes.

earning a is about can't sales. in talk dollar but get so royalties you're past they million their million start XX we'll first right The XX royalty guidance I we their free definitely about, for once

George Lasezkay

And a that it Phase it, potential OASIS, other obviously CLS-AX. for Xb was AMD for then in about doing currently, Tom, believe I Jon trial indications patients. thinking wet we're And asked our Jon.

Dr. Thomas Ciulla

edema, potential There's are retinopathy, diabetic this edema. retinal occlusion sort indications classic Those macular end vein of absolutely. of Yes, related sort diabetic macular and for the other therapy.

made those this haven't point. So, we discussed firm any decisions at and

George Lasezkay

correct, Tom? basically VEGF all are Those related disorders,

Dr. Thomas Ciulla

potential the where also VEGF all related the And, can We as targeted think approach They're diabetic to peripheral to here we particularly high potential get retinopathy targeting, levels durability this retina, with well. we the for there's real and absolutely. disorders. think start. retinopathy of retinal diabetic tends Yes, the periphery

firm this of decisions So, made potential with haven't approach there's a lot any, yet. again any obviously and we

Jon Wolleben

Okay.

Dr. Thomas Ciulla

lost have might We Jon.

George Lasezkay

last That was the question.

Dr. Thomas Ciulla

don't George, give you closing remarks? why Yes. your

George Lasezkay

Okay, all now call we We may I disconnect the the Well, forward Clearside that call. on thank to question, right. all appreciate was right. this last want Thank progress. everyone look Since to you updating for interest you. the us you on afternoon. our joining and in continued Operator, your

Operator

Thank you.

disconnect. As you safe Have a well. now and good reminder to participants, may day. all Stay a

Clearside Biomedical (CLSD) 11 Mar 222021 Q4 Earnings call transcript