CLSD - Earnings call transcript Q1 2024 | Clearside Biomedical, Inc.

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Operator

Greetings, and welcome to the Clearside Biomedical First Quarter 2024 Financial Results and Corporate Update Conference Call.

As a reminder, this conference call is being recorded. I would now like to introduce your host, Remy Bernarda, Clearside Investor Relations. Please go ahead.

Remy Bernarda

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

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

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

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

have Chong, call After turn Executive remarks, over On I Financial call Chief Officer. will today's our our Medical we like now would Deignan, questions. Chief to the Charlie the open Chief George and we our George. call, our Lasezkay, Victor for formal Dr. to Officer; Officer;

George Lasezkay

good you, Thank Remy, afternoon, everyone. and

stages the rademizumab advancing for drug AMD. to well-respected on of we years meaningful midpoint team we and near positions experience with has than we retinal the through who more our progress made aflibercept Medical immediate all I'm specialist As XX the March, are Chief Officer. Victor organization. In Dr. an board-certified impact to Clearside an our and of XXXX, is added development important a Victor welcomed key we X excited for wet as including have Chong having positioned which date, our of of development candidates year. Recently, with

Phase extensive Victor our to these data product at Victor he Medicine by Ingelheim. And Victor's be Retinal recently, at planning program. III Global Health spearheads in & the he of Boehringer Global as valuable CLS-AX development Head upcoming led was ODYSSEY Retina Head as discussing the experience prior Johnson will and that, our analysis served extremely is Most of activities, shortly. for Johnson.

he our expertise in month, finance biotech and was Tony IbericBio, the value-creating Tony Last Clearside. and guide broad combined at that deep as with Directors. Gibney, a has strategic biotechnology future to of explore seasoned added Chief M&A relevant of of initiatives will ophthalmology understanding business executive, Board Tony Business where Strategy and we business and and opportunities has also Officer. our development help we collaborations, recent experience

are in important build These personnel our position on additions as delivery. to we continue suprachoroidal leadership

thousands Our in injections technology has clinic demonstrate of in and strong endolphalitis safety cases been to continues Microinjector date. record SCS that of to no includes used the a

the suprachoroidal the range and developed as our delivery pioneers those to depth proud broad are retinal the a well in our of internally pipeline. of As from breadth assets we collaborators diseases. space, in our That of as includes

and Victor Medical now our who on provide programs. will With perspectives like introduce Clearside our I'd to his Officer, joining Chief that, Victor? new Chong,

Victor Chong

Thank afternoon, George, you, and everyone. good

a have I by now, CSI the almost X been of on with all for today saying months pleasure chose share from a is J&J. and reasons our member you me begin broader Let of I'm extremely prospect it team. I I to well board as technology pipeline. excited the drug to as some by of Clearside as join of to our the device wanted speak

data our team readout as decade and large forward our only including ODYSSEY suprachoroidal treat in a scientist, undervalued pharma, program but product by platform approach our to we I Clearside believe a background FDA-approved leading way I First, With important is look margin, having planning very an to a for the with diseases. almost is begin delivery Phase leading for suprachoroidal III in the retinal my use. the the approach physician suprachoroidal CLS-AX. big combined as

finally, see and can areas CLS-AX platform our drug And my opportunities I molecules our as to new and for many I differentiators focus such clinic ODYSSEY utilize clinical expand device formulation atrophy. company's see to to potentially translational the advancing the pipeline want Today, into and the expertise into and geographic on in the trial.

for fives delivered market reduce approved up some to in and for app, patients. and months treatment The $XX than believe only including individually therapy while time lasts and meaningfully existing X driving payers. which they for is We sales, more months the current most resume are could patients. caregivers burden may to in the are CLS-AX between billion effective, doses annually X up extend AMD the high-dose patients,

the a from design to find differentiated compelling mixed AMD ODYSSEY trial that I the of other phase be many is study. wet

currently drug trial own our the to on First, market. to designed if similar which is retreatment was candidate, anti-VEGF to with X allow the the prior months, needed

CLS-AX retreatment even III our participants X, retreated. the at to the arm program. multi-dosing chronic protocol will is data previously the and addition, in month disease this CLS-AX in development redosed not a In mandate Phase is -- if Whether be inform help

to duration trial design the more follow results by the to us AMD. wet Phase This required Phase for translate III for III close months. of us weeks in is IIb our Second, beyond to duration to XX FDA primary patients allow CLS-AX allow easily. Phase X It trial the endpoint trial

we definitely line a confirmed set the end disease pleased I'm the have this of we And progressing data of that will patients is at with ODYSSEY report to active quarter finally, to planned, third is year. patients so ODYSSEY results who on treating need top retreatment. have and expect as

for for equity potentially need with without target Our is up maintain the profile retreatment for CLS-AX X to months. to

robust to Charlie CLS-AX. Phase provide at Deignan provide insights III forward now We call expect looking IIb development a the program over financial to CFO, our and a will journey final that for Phase to the will important to I'm this create Clearside data turn update.

Charlie Deignan

good Thank afternoon, Victor, you, and everyone.

XXXX on today's quarter available call. first the are our of will press for published status in financial just summary and earlier our a release . results were provide our on Therefore, I website. financial Our

XX, XXXX, our through As resources into anticipated planning supports us equivalents CLS-AX III operations we planned cash have ODYSSEY million. $XX totaled Phase approximately the our XXXX. We believe year quarter third to This readout for of and and takes fund data sufficient the this March of cash trial the our program.

week, Conference closing you now will over We Life on keeping turn JMP in next the to will be call we forward participating look Securities progress. remarks. for Citizens our I updated his the Sciences George to and

George Lasezkay

Charlie. you, Thank

will XXXX for year be Clearside. expect transformative a We

as generate the ODYSSEY additional clinical our the of benefits regimen believe CLS-AX the We partners are wet the data, the we and committed demonstrate to multibillion-dollar year in demonstrating drug AMD maintaining SCS delivery in this space treatment will could data our our leadership a later to from that . We role be valuable that readout Microinjector. market. suprachoroidal potential addition with

Our efforts and potential delivery physicians lasting provide in developing serious a treatment and retinal for have our suprachoroidal positive the to shareholders. patients, diseases the change impact drug paradigm for

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

Operator

[Operator Wolleben JMP Securities. Instructions] with comes first Your from Jon question

Jonathan Wolleben

other criteria active reminder to how get hoping is mid-stage was from and the a I on produce disease trials? what constitutes inclusion that as just

George Lasezkay

Okay.

for I you. think -- great I a question think Victor, that's

one? you take why that So don't

Victor Chong

for Yes, or leakage. would the that it the that protocol foresensing we Jon, require patients or the still on insurer have foresaid

because patients they find would have and treated treatment. drive still and remain already some to . is active not that have what would So and be been we might disease service then

Jonathan Wolleben

in but And to Okay. comparison about CLS-AX as talk in you what about And variability, feel development? to in the package other a little provide? in do then, investors the how mind keep how is readout XQ? bit interpreting they're TKIs you is about what we lot about data you'll for can important talk this -- you think also, And most a

Victor Chong

Yes.

sharing the And much lower So X are different in we they when important. we most have comparing and antibater with among base believe in of that iPhone certainly And is and that more the the other play, you words, entire another ICXX potent. -- companies offer in that TKI. are therapeutic even is say terms that is X TKIs have that

In missed second you terms question. quickly the of Can repeat? sorry, I just

Jonathan Wolleben

key more talk worry had look durability you -- endpoints, think of year be on? giving What treatment? the last we about if these trials to a late-stage about burden thing as BCGA, you'll we'd to focus us, should in about We at what

Victor Chong

Yes.

Phase very have that's webcast we a our III Phase mentioned help inform think think that would least that But as think moment, design. already, that at we the that my question. that, us I But that the the in at I have treatment. our waiting still data good At same time, So that I earlier discussion I II for are results.

up okay ones, be will ads in if been patient at every X they even retreated doing have least months. So until

trial to that our will And months. also is months X data and longer. So recruitment X up get also

again, to endpoint the the day would say So important. is closer most that's acuity I timing requirement the FDA with end for the of

I how And something -- around as will well will that meet that the the we we FDA were will requirement on other that the require to focusing the as be think reactivity that measure agency world. of

Operator

Your next question comes from Stifel. Jay Mom with

Unknown Analyst

questions Jae for This I have calling X you. Annabel. for is I'm in

of Phase design that of realizing given II of superiority thought the your standard III competitors CLS-AX. to some any still to Have funding further question, in trials light you're First with in you Phase trial care?

George Lasezkay

data doing now, come while first how waiting Well, data is to undergoing our planning we that let Ib in the internal III, say for we're we're me out. are Phase comes what on depending Phase for

all you So anything want designs We're trial consultants. already And that's that? Victor, at evaluation to we're But III Phase that. time. with this discussing add do looking to at our under

Victor Chong

Yes.

And on the mentioned key that, own then working think of the that for still is are it. us difference somewhat our are we drug. to is a we that considering. options I the number there day, that But can based retreatment I of we earlier, as end on

could difference in other TKI companies be study the So a do. some not may to that that design able be major

advantage surrounding same to again, that our how easily. is in we drug time, can that future better that So specialists we the maximize will future more on providing the something at use see

George Lasezkay

second You question? had a

Unknown Analyst

did. I Yes,

come was based the trial in the no FDA, have on paradigm, they The is mainly . new closer any to question shifting guidelines clinical regards second establishing to treatment

George Lasezkay

Is conversations. year plan their on FDA the Victor, that that talking on tiles. guidance, have finalizing draft based they was for where you to mean date their what wet close about? draft more to to recent come might previous you're is you a up our started You AMD like over ago be think guidance

Victor Chong

Yes.

not I long a obviously time think the and finalized. guideline a not as but for potential that that than And the still for yes, are FDA that have is when community it more well. concern, is guideline unusual year some draft has a old,

consistent in with So it's hard the of that to predict, but on practice. suggest was some time that the corn line

I difficult confers that that again, discussing be that multiple there's moving on even platforms. ship But FDA that be to or well. draft the is as as you might there different becomes or is know, sure. still And again, change So multiple also especially, that something different everyone interim think finalized prior well when are exactly as a in lasting to recent whether

George Lasezkay

we multiple to times with we engaged will any obviously, before trial been And plans, III once, go announce at the III agency we Phase have not as least discuss design. forward Phase if

. So reading from our planning them agency continues. we'll get in as most up-to-date the conversations the our with

Operator

I Lasezkay like to further George remarks. call any back now turn would the to for

George Lasezkay

our I look Well, call can . the that, progress. of today. everybody say the call. on We you thank to operator, want for apprised with And forward that being the you end would to keeping I

Operator

First today's for wonderful Update have rest Corporate of Clearside concludes attending, and Quarter your This XXXX and a day. Results you Financial Biomedical Thank Call.

Clearside Biomedical (CLSD) 9 May 242024 Q1 Earnings call transcript