EYPT - Earnings call 3 2023 | EyePoint Pharmaceuticals, Inc.

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Operator

Good morning. My name is Liway, and I'll be your conference operator today. At this time, I would like to welcome everyone to the EyePoint Pharmaceuticals Third Quarter 2023 Financial Results and Recent Corporate Development Conference Call. There will be a question-and-answer session to follow at the completion of the prepared remarks. Please be advised that this call is being recorded at the company's request.I would now like to turn the call over to George Elston, Executive Vice President and Chief Financial Officer of the EyePoint Pharmaceuticals. ahead. go Please

George Elston

results, is thank review conference and EYP-XXXX. morning, and third trials XXXX for us be discuss financial A will Phase me joining the for results can Chief ongoing release President Thank found release Officer. will the website, quarter recent call results the Executive developments. commentary close we to you corporate financial of recent discuss and today's Jay today on With developments. call recent press this corporate with quarter www.eyepointpharma.com. clinical will the Jay on we EyePoint in on for I Duker, and and with a detailing a questions.Earlier the open you, begin our corporate the all tab Dr. copy of Pharmaceuticals' II financial operational then and XXXX your third updates issued Investors

success Risk views SEC forward-looking filings with file only. our our and of our comments, other we discussed that report may the statements candidates, various as we the forward-looking these our annual safe include Before of statements result in potential clinical Securities and you the expectations, today may and under products future. XX-K, in constitute will important harbor section purposes most the make Litigation SEC the that we on provisions by including remarks is the from formal statements statements as the Act today a Private begin of differ forward-looking matters for plans and Reform I'll those and These Any and indicated prospects.Actual Form lines, those with financial the represent our future materially projections which regulatory of product various time on on make XXXX. factors, in developments recent about of results remind Factors our

statements we at subsequent the to today.I'll not specifically and do our Duker, forward-looking to rely forward-looking as Officer Dr. these call views of point Jay so elect as disclaim we views President on our representing some even should Pharmaceuticals. these future, EyePoint now obligation may of the to to over you update if in Chief statements turn While any any Executive Therefore, date change.

Jay Duker

George. or of disease. Tie-X X DAVIO in line or formulated It's early our now trial II next AMD and our with as results to from ongoing EYP-XXXX PAVIA which top XXXX.I'll of as to discuss Phase third an thank everyone, we diabetic catalysts. you, approach review continued Thank in EYP-XXXX of Good and safety positive quarter, PAVIA the technologies as Phase in anticipated in the for and unveiling age-related in lead program and formerly corporate an clinical updates December trial overview results wet in as plan of first-in-class bioerodible masked you Durasert our product delivery serious activator, advanced us data in morning, DME initiate expanded our third In II eye bring data QX trials diseases. therapeutics E to known time is promising recent candidate, our retinal and toward our edema EYP-XXXX. pipeline the macular preclinical and new a patients joining year, delivers we events with degeneration as Durasert product a outcomes we and upcoming suffering of milestones announcement work diabetic potentially QX Phase razuprotafib, II EyePoint to program, as and vorolanib to EYP-XXXX, execution wet key EyePoint's a at our the proprietary exciting molecule AKB-XXXX DAVIO clinical E technology, small X both trials well give and improve macular and for

by Turning diseases. to of and constant release bioerodible Vorolanib VEGF proprietary featuring paradigm-shifting potentially isoforms. office kinetic delivers with VEGF-mediated receptor EYP-XXXX insert vorolanib, is a a is near treatment our for an blocker, immediately of patients for the approach anti-VEGF X months.EYP-XXXX FDA-approved brings blocking a EYP-XXXX drug, initial delivered is zero-order bioavailable, suffering the retinal lead acting approximately treatment current treatments. E formulated from to physician's a solid in followed to EYP-XXXX similar using the biologic mechanistic tyrosine as pan-VEGF our advanced retinal technology. single new being in kinase inhibitor VEGF-mediated a selective sustained-release program. patent-protected by a all diseases as intravitreal injection burst Durasert

to neuroprotection new with for doses in to and keeping vorolanib a on tested clinical is pathways critical retinal that drug AMD demonstrated function. burden physiologic a and We the vorolanib vorolanib Unlike pathologic does to vorolanib the TKIs last Tie-X, because axitinib, of PDGF pan-VEGF wet may improved of rodent retinal a from multiple [ present at stable.Vorolanib meaningfully as ] also its vorolanib, antifibrotic Tie-X anatomy showed the sunitinib, TKIs, promising with off-target In of a relevant have angiogenesis.Importantly, melanin. One underscore clinically inhibit in disease. majority medical profile reduce data month's to We not expect blocks months treatment critical And profile detachment, other stability, vorolanib that comparison reduced sunitinib unlike X binding pathway while Retina blocks the an sustained benefits. features receptor not a normal meetings of of up not delivery retinal where associated bind differentiated to highlight the pleased impact that data Society and anti-angiogenic at may does validated and the preclinical efficacy. vascular of EYP-XXXX expected and result it patients and MOA EYP-XXXX. have model axitinib were X inhibitor was at Meeting, in vision is which effectively

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is it that the XXXX safety continues clinical EYP-XXXX through the safety profile X, of the BCVA, October In addition show EYP-XXXX update favorable critical with to a all masked interim stable to consistent trials. across

X the critical reduction to treatment therapies. also reported post completed endpoint.Although DAVIO SAEs will injection trials continues systemic patients October and durable of give confidence consider no of SAEs. ongoing approximately population to outcome endpoint, clinical need have Phase drug-related trial this given us I patient this best unmet burden DAVIO a PAVIA results crucial the As with XXX is II secondary for follow-up of be the acuity from months a ocular X no with change primary corrected and the drug-related received X, in more minimum in This the visual EYP-XXXX reported and Phase in in

the or a injection burden we believe that one at need in better week EYP-XXXX treatment meaningful following of X. for EYP-XXXX to minimum both arms a months X For in reduction clinically XX% of result or a outcome,

up with treat host initiate reviewed. the ahead us DAVIO just outcome research you of to as be visit, Based discuss for will KOL several also call treatment informative months call presentation quarter fourth week maintenance their in in the by find will free landscape Dr. can should Time and Boyer this link that Dr. be considerations perspectives later. Investor X plan we trials therapy believe initiate current on relatively and and these at of X EYP-XXXX the to all OCT. U.S. tab be who that trial XX our or EYP-XXXX XXXX. for wet you specialists, and I is measured and as hope along endpoints to the website.Looking specialists by Eastern AMD a to join the hope David We will second first the to largely trial a.m. III X retina AMD, plan retinal to to the patients. Canada. the November initial and Phase trial pivotal and current with meaningful potential the our Lally the on renowned David We We that wet on eyes to a virtual of addition, stable our a supplement that interactions, anatomy treated greater In market XX% This pivotal Q&A,

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turn trial with a June, was the that in patients NPDR. coming in randomized EYP-XXXX, In office. the randomly clinical we EYP-XXXX PAVIA XX share group is during sham for injection.As NPDR. to is We and were investigator or trial XX milligrams a trial, our let assigned II moderate target. Patients PAVIA about the to interest approximately X-month saw severe trial Phase significant II X milligrams indication, X that patient patient potential enrollment. PAVIA physician's delivered enrolled reported me controlled The of as exceeding approximately DAVIO wet X more of to X or treatment single intravitreal X expect received complete. months.Now a to doses who AMD the evaluating the details to trial the in our trials, EYP-XXXX to a enrollment control the second Similar injection Phase of trial this

threatening trial. blood is disease convenient loss. of remains in diabetic projected reminder, risk proliferative a of Both to that apart edema well million the DME, reduce NPDR, PDR. their these an trial doctor analysis disease adults trial from X, masked ocular ultimately to called reported common to a first the for Americans almost from EYP-XXXX's in diabetic with on course EYP-XXXX a or PAVIA safety the PAVIA from as no of affects the October NPDR treatment proactively the SAEs, age we blood protocol. XXXX, treatment PAVIA demonstrating or As could X/X macular PDR. swelling progresses are interim the drug-related Phase for that potentially note time. observation the initiate remains Top reduces potentially EYP-XXXX currently unmet leading over complication quarter result a In of our with efficacious site diabetic which by clinical showed is or plan which and in Recently, NPDR II for VERONA and eventually Phase profile by with and XX XXXX, reported we less very for safety excellent therapy to vessels NPDR is progressing NPDR, patients mentioned we it's weakened, vessel data a severe over important of result visual II XXXX. line drug-related systemic tolerated receive data great NPDR trial growth, XXXX.As DME in trial second a of which calling need EYP-XXXX impact of track was no quarter Phase eye the DME are retinopathy which progressing XX% called evaluating to II intrusive to in retinal may over risk of PDR in there abnormal DME long-term.Approximately that the macula, earlier, of a and/or complications of of in and It's that their to first safe, the could until XX the

to we The the tied is to is months delivery this of goal that agonist, VERONA in potential the This and disease, the combination to we appointment patients either Stuart delivered and preclinical role. diabetic Directors clinical show intravitreally subcutaneously, who that retinal EYP-XXXX than eye offer biopharmaceutical delighted expanded that disease. of delivering experience at the indication. treatment razuprotafib, intravitreal of a with September, program formerly We executive gain called in in known EYP-XXXX X AMD demonstrated sustained severe razuprotafib will provide treatment EyePoint as has longer AKB-XXXX, disclosed improve of which large with share disease. the Previous Durasert a eye future And studies preclinical trial diabetic details we experience in proof-of-concept date. potentially more for with a site-saving over trial to or to with of potential that believe alone to of new EYP-XXXX. wet to new EYP-XXXX have years the work financial formulated has announce seasoned anti-VEGFs.Finally, its E. Board or In Duty, XX were brings we to

incredibly at leadership of for we tremendous the George? build their continue our for CFO, guidance strengthened We like I growth. George welcome value grateful and financials. been the additional entire over leadership promotion George, EyePoint with the valuable in Elston, EyePoint financial our and to active Vice our during call President. George's our we has leadership of thank experience, also congratulate shareholders team.On acumen of we asset George the EyePoint turn an team, the and this the as now executive review Stuart the team Executive quarter, team to to entire company's time and are I'd to productive wealth a behalf role of strategic to to will for

George Elston

Thank you, Jay.

ended XXXX results comments a included X focused on financial XX, the high-level [ quarter. morning, be issued the for in months today press were release my the for will ] September this the review As

XX, with XX, third XXXX. XXXX, $X.X YUTIQ to Consistent exit million due in marketing in $XX September $XXX.X net for sales of per loss share million. XXXX. trials, $X.XX million product $X.X the million net million ended collaborations XX, the lower compared quarter period clinical year royalties decline revenue marketing $XXX from for to September September XXXX, DEXYCU and at for ended $XX.X prior to net by at and For net primarily period. quarter recognized business, totaled expense.Nonoperating the ended million from which totaled Cash in for the franchise commercial prior the the was of reimbursement EYP-XXXX $XX.X R&D period. This year to $X.X will X-year over a due was X/X/XX.Net Operating sale compared a franchise investments to of Net third XXXX deferred effective the quarter versus September was million activity XXXX. or was with the in revenues million the resulted the total the by loss of revenue the quarter pass-through discontinuation $X.XX expenses XXXX, YUTIQ, increase revenue increase XX, per in expense for this from in XX, million million third XXXX, compared XX, of year. $XX.X the XX, of million year revenue spending the share totaled QX September The quarter May higher in quarter $XX.X and of September revenue and net the partially December product loss XXXX, period, the $X.X offset $XX.X was third of ended on $XX.X CMS ended along driven compared be which by primarily compared the to or sale a recognition million the to third began from this million corresponding totaled for

with for our and third back well inflection key cash are investments equivalents into closing enable cash, conclusion, our to the year-to-date on expect XXXX, value and turn advance XXXX. remarks. We progress the the operations now to current XX, points.I September pleased fund to pipeline capitalized call In are we planned quarter in and will to Jay and product us will over EyePoint's

Jay Duker

with much the questions. morning. in next the in for improve PAVIA execute all EyePoint George. suffering retinal EYP-XXXX Phase very benefits a is treatment on over EYP-XXXX release the ligand Thank incredibly and of We blockade, providing turn vorolanib continue believe paradigm-shifting retinal approximately unique the serious potentially clinical delivery milestones vision you, quarter the may mechanism treat over operator disease long-term and beyond well in anti-VEGF quarter for upcoming trial potential landscape patients a of technology of to line action with DME II of positive a solutions consistently the I for early diseases, the from second of a include are year X new by months. X listening December, that top as the first serious in will now to remains antifibrosis and delivery this with treatment for diseases.Thank neuroprotection will trial Phase patients exciting you VERONA from key the an patient both dosing top first the line retinal to in positioned of and it to trial profile.I lives time proven data Phase and data catalysts, the upcoming recapping II close our our from including transform our DAVIO anticipated II clinical XXXX. for we safety clinical This to innovative of

Operator

you much Thank so presenters.

of from Our the TD Van Cowen. question comes Tyler Buren first of line

Tyler Van Buren

on for Congrats progress. questions you. I have of the a couple

what ahead trial, to the First the been DAVIO the can ranges top I they of sorts outcome these you III traditional KOL to your of And see how what were to think regarding of upon And AMD upcoming question being program perhaps would with need preview scenario program? respect start you data, appreciate possible a guys an the constructed But one you talk Phase the the transparent it second event? should been data. on quickly for elaborate can is, more feedback X has accelerated of KOLs? you have in data line be a accordance Phase the with the trial then from time to get able it wet we fashion is, about in KOL And is positive line? or III BCVA how

Jay Duker

appreciate the Tyler. questions your Thanks, interest. and I

ranges, ways pretty the X letters. the with of way there's And got And is X.X really first look BCVA all, be so minus kind the to does want? noninferiority that's First what to at respect FDA this. of the margins to clear,

You change have, not And you with get as is a them, profile it when think generally of your could is type efficacy noticeable of asked in what and they a good X they're X.X end what second safety I good letters.It's to numerical that, your it in long and cross in the come of does interestingly, deviation, general on to can't you patient. with And range part is that ask your you interesting vision profile, pretty letters the that and of X standard to study your fine that depending the I'm you the intervals. confidence KOLs want. believe close as resolved. change sure But the

as we, of a company, a it On combination of the hand, other look at those. as both

And so or better. minus X kind of that range

meet of anticipate might I deviation and what would we noninferior be trial expectations. KOLs' pivotal think likely be based trial a in the the on the standard

closer great to With half start Phase in fourth first second but data, course, the can may there's we III. considerably be results We'll III in approximately to question that.Second was could we know we Phase the Of reasons than better of trial quarter. on to the month, believe the do the don't start that are believe the next yet. we It know what of good a year.

to prep the basically it on Phase zeroed do company really on Suffice we for X for trouble months. on I perspective, start and ready, lot it's year. haven't an is From half and end. And yourself We in second goal our I that. early is track Phase the I else? really been it here.And And was a stay, unmasking last has penalized to the with them get to think them our a get opposed III the penalize low think best of there's the continue be an cost to next be statistics focused in speed to can and that higher ends, as for to done to you fast right with get Anything done do critical ]. accelerated with early if we [ hope IIIs relatively look suggest sufficient.

Tyler Van Buren

that's clear. No,

Operator

next question line Suneja the Yatin comes Guggenheim. Your of from of

Yatin Suneja

you you're data, Phase in on the obviously III. focused but delivering mentioned So these that just Jay, also

think necessary single when for TKIs aflibercept So the mechanism a get it why competitors about your you talk induction and how then to thoughts that And can of there. are would a does the just patients has AMD? dose also a just love your as it study my question doing wet you to you EYLEA is, relate induction competitor I is with comparison? to superiority in the to do maybe to with is do

Jay Duker

questions. Thanks, Yatin. Those are great X

the induction. me start with Let

perspective, the scientific patients with a anything unclear all, EYP-XXXX. First to offers treated of from if induction the it's

reaches levels bioavailable the of hours. minutes within is in We cohort data good and our in that injection animals have pretty shows therapeutic preclinical drug of that

enroll reinduction of therapy you meeting, them. from the we're the response pivotal probably to our is go yes, to the said, every well, EYLEA. these like we as the the of wet we've may month, for Makes the around go to use make reinduce be EYLEA. every the beginning out the as hand, C other eyes in Type patients, Phase came you the The us structure AMD set our when did, sense. the assumption trial therefore, you to our think real then are reload study. undertreated discussions before the on-label with a What other to going reinduce endpoint undertreated. And And after got using reengage and EYLEA, study.And III. III start the previously is in world, were them you true, And an X-month patients. months do to EYLEA On all until we that ticking we which to the in patients to if after had allow to that something FDA agreeable was, the a had decision to treated AMD be discussed we some they that FDA trials.When however, reinduce can X you wet that you can EYP-XXXX up agreeable month But efficacy Phase patients the we'd FDA was have our as with to may the doesn't FDA's the that. aware, rationale on-label And the was certainly of in other control in maintenance you've

X weren't flood level the trial, the relatively efficacy be trade-off sure to make to was was, in fair and a able was So our playing year. that the what approximately that patients allowing we endpoint arms. here to field the trade-off to we it do EYP-XXXX pivotal needed thought We undertreated out

induction? So I'd it reinducing.So our derisking. think the decision to and to a fastest this again, really with comes out the and I into discussions I FDA that Phase Again, least FDA isn't I say our and why risky -- that, The think, covered reason more We gets I've question, pathway second we're think reason. a a that. is, noninferiority typical the scientific that a it's reason derisking regulatory is of do this, III think, approval.

George Elston

the meeting C Phase remember, a Type had II which Phase laying would remind inform I'll we that, you with FDA out III. plans,

so big next year. driver Phase that's going the And IIIs into a focus of also

Yatin Suneja

helpful. Got it. Very

you Just in about this study. doses one I dose more the talk X are There Could if may. question, response?

will just So how expect? And expect like on you just you if is the no say, what dose we Should response? response, curious would any forward. to decide dose dose curious if, take there let's then

Jay Duker

know efficiently shut additional certainly And for you don't really response may if not the work a receptor we dose to that And Yatin. additional any be question, great there another therefore, X-milligram our drug it's down give will That's dose X months. to Yes. possible because will benefit. up

So to around X-milligram What I it's pivotal milligrams. And some trial hand, X-milligram other eye ]. validation in dose to little great, the we worked we're, fewer the inserts and successful, same, mean our our go if course, a there's the lower both dose and against would that. a essentially with if that X-milligram dose us, would in to our that approximately the cost say response. a have understandably.On agnostic and would show a to enable bit I the do, they're most nice X company, is to dose [ dose, likely of opt as lower

Operator

Your of next the of Kim Jennifer Cantor from Fitzgerald. comes line question

Jennifer Kim

I have X.

the remarks, or just with letters your pushback prepared good. X in touching The most is first X on minus I on you BCVA said I've think X scenario. question, The generally better BCVA of difference the are to gotten aligned a be investors that. is think letter Jay, change I And minus would letter

with, assume standard that scenario? that see than where letter if to And was thoughts scenario be better than get this you have we've that, So have case similar Is to better say, hope X statistic to the base [ I a PDS? that? seen deviation would what a it or on minus in ] curious will you difference, the any

Jay Duker

questions. Great Sure. thanks. Jennifer,

X minus, less a mind X best kind really X would acuity corrected or I that, X.X letter that a statistically pivotal be a be, of point then kind to in clear the here deviation could if large a pathway range difference it with difference Minus minus think the argue into non-inferior. would a trials. everybody's in visual in enough is be say, and of small that one we theoretical getting replicate standard can enough So of you're could that let's successful. But a where commercially where

after say, the of better, or first approval, KOLs second on months we everyone but know in would the X I I X.X may and it course, the would and letters was relatively be is, the and EYLEA while be meets as it that stable outstanding week this to load arm would think would expect result. might really the we replicate bar centering of I'd you -- that And EYP-XXXX And I to between FDA minus the think the say, X X.X yet, want, we So and that again, that injected. meet want would letters at weeks for can that, Phase meet see control again, of expect bar were everybody's don't as perhaps, result.So I after test if the what minus community remind X investment here. what XX. an success one one a it not

at significant.So statistically of letters again, again, the was noninferiority you what of depends need in pivotal mentioned again, we of what acuity a think to pivotal look to could very I words drug done and had That's case, everyone approved be if a letters. basically, the standard change lot go what generally X -- an PDS basis see the since back wet would deviations, think visual and treatment-naive and EYLEA the because to treatment-naive. was and it's one do they're on around this that tight patients and in XX base AMD, the even So I with into deviation standard minus you trials view the standard on trials. advance the deviation And

III of respond, length some don't. prior. enrolled PDS like eyes to but we months diagnosis limited the Some eyes treated to previously time did, patients they The Phase X

So and letter deviation. were They treatment being a weren't their of X.X standard disease of treatment at extended. in eyes stable yet.They pace had those -- kind of early still relatively of their some their still perhaps

that to our So the enrollment that that. could be the believe standard questions? of than That X had our because we suggesting eyes have are of reasons than but stable, they'd lower be more longer answer months disease deviation

Jennifer Kim

Yes, one it If could, does. I more.

Jay Duker

[ Go ahead ].

Jennifer Kim

this or under wondering seems have we're news the But takes world -- design guidance given morning. if for Net-net, good that I'm their in. draft they received on superiority the post competitor Your an announced any you like received space that? overall this agreement trial

Jay Duker

they're and I would comment way III the Well, And the all last news From point, clear TKI But are is for the to it's this And details is our able approval, that It's like a high I a that FDA just to the Oculus and our look to news. space. from derisked. to new into FDA good already through again, we if this with yes. very for though, ] Phase this meeting, [ pathway think C design, learnings the are do as results level, design. we with and clinic. know, this, details. that commented have investors Type comfortable then drug.Again, company to, great the willing received, was is paradigm approval our take again, any which at the if to Phase very there's get state, see once work this we at And get and to represent doing. spot least at our that approval. the should for trials approach companies we on to to great program risky comfortable our there's about When shows of fastest, what the advance will, no are we great great things us has is seen it see we're II the pathway our perspective, see because morning any pivotal with our But think announced still of a that I with

Operator

next line Your from of line now of open. the your question Baird. is Kusy Colleen, Colleen comes

your You question. may ask

Jay Duker

Colleen next to after back one. go could the we Maybe

Operator

All right.

Your question Chardan. comes of of Gataulin next from line Daniil the

Daniil Gataulin

EYP-XXXX. some And that a does there for was called. on overlapping EYP-XXXX was product. strategy this could one thought I wanted how that with quick for fit be have the specifically, it that to Yes. name couldn't I given I ask rationale I my hear. indications?

Jay Duker

assets Thanks, and pivotal although aware Ang-X.And is activating or diabetic delivered is lead a We've promising the into company by retinopathy. to you a not and VABYSMO and diabetic by you be And enable results, down-regulate Daniil. trials. that been Phase Tie-X. subcutaneously studied Aerpio. product, really That's visual based activates around molecule really vessels for their angiopoietin-X forward blocks that for company macular edema VEGF II did may acquired question. bispecific was and AKB-XXXX great that's a their anatomic called EYP-XXXX a showed And it the you blood This go drug stabilize blocks Tie-X, results Ang-X. into

validated. Tie-X. believe So now, a block activating be of we pathway better Ang-X that that pathway that is by And may EYP-XXXX way AKB-XXXX, to blockage

at Secondly, deliver sustained-release. now we can

can require believe levels over deliver And therapeutic these injections. frequent relatively at EYP-XXXX. months X with still bispecific we So injection for we single molecules a of

does fit how to So seen. it remains in? that be Well,

or we label I to think noninferiority choose for course, develop riskier fashion using wet could AMD we in standard for a either ceiling. in so care it that high a get or it test DME of against would be because anti-VEGFs the sets a effective, a the it both and could an That, trial perhaps conjunction go with superiority are to of anti-VEGF. it or really

to single a of each molecule. combo what do nutshell, going pathway, a and permutations long secondarily at. we with inactivate to but Ang-X with envision do relish to product EYP-XXXX the with we're and hand, Tie-X other to day -- it's alone.How can do doctors derisked that would would is as successful into look and pathway because that would one shorter a if even go stand-alone to injection. pathway the you and have we've Obviously, have a because as there's could anti-VEGF On highly fit we opportunity speculative, fashion you activate likely got when could sustained-release approach, it of dollar it EYP-XXXX, the than both EYP-XXXX, a that pathway a in do lot in it with you with believe better approval a EYP-XXXX, a But is can multibillion in a one long one

Operator

Your next Sean JonesTrading. the Kim question comes of line from of

Sean Kim

a just have couple quick of ones. I

I So requesting DAVIO trial trial the following FDA end be an the readout, guide X Phase the for design? with wet AMD further II the to guess III you of program, would Phase

Jay Duker

That's our plan.

of currently both In gain end fact, in both II Phase II having Phase a end of we CMC a areas. to would clinical plan and those on alignment

Sean Kim

that Okay. of Got you. meeting? And potential the timing

Jay Duker

may first quarter the next get say we again soon early late in year, submit. from of depending next bleed can year, quarter tables DAVIO in how X I second can the clinical format a would into that we all of

Sean Kim

I Great. Okay. And guess...

Jay Duker

the limiting step really That's here.

Sean Kim

expecting the from Rallybio what be inhibitor in we complement And you. Got that collaboration, program Okay. should what XXXX? updates

Jay Duker

in as answer at really We're wasn't last complement about is we're already. the that to it a them a levels collaboration. of months about kind excited inhibitors challenge, is, Getting Thanks for a said the And It's the we've question, you'd Sean. good question. several before, see eye If molecule. the therapeutic really excited challenge.

that and confident complement great that. However, we've have until make release ability we we will consistently, our But be and made remain progress, statements any we are able this public a around to sustain formulation going -- optimistic inhibitor. we're not do in to our really to

say we're I on again, it. So working that, still would

made have We progress. great

easy an have working task it's some but accomplish. not scientists on great We this, really to

George Elston

Yes, to and has -- gotten the pathway should those on just like. Sean, disclosure, past point more we we that it think in Once start quarter where this what into you maybe space move EYP-XXXX I because preclinical how we talking our position complement it look we're disclosed because to as little I can at right a a think formulation And cadence add to on programs. formulates we've we've well. a the if window, that for you that same the we'll publicly about get and know that works looks it it

Sean Kim

as III Okay. runway you're me in wet the include potential trials Does in that looking cash about well to now I from second into XXXX. AMD -- the is one pivotal that III got that last start you. half? Phase And

George Elston

that question, Sean. for thanks Yes,

got the IIs. previously, will that's sometime to [Technical talked interest as to along plans equity to Difficulty] III -- we a our we've -- Phase So levers I'm of raise. which on planned trial, that strong Phase is in options start Phase pull, can position the amount DME, that over not and ongoing for we're VERONA The results. we significant start Phase start fund of a we'll be the range XXXX includes II to prep going something strategic and after the partner It which to that pivotals. half of about sorry, guidance include includes a second the cash trial which And talking with really in to next our into cost that does our year. potential fund, trials to clinical -- QX, some in We've actual other to the coming look months be the Phase expect

Sean Kim

Okay.

George Elston

Good you. Thank question.

Operator

of the Yale from comes of Company. next Jen Your question line Laidlaw &

Yale Jen

And Difficulty] study. Phase the future on my potential [Technical be focusing III question will probably

laid size one those just presentations, you of first different Phase under of The a BCVA III in each I'm Phase scenarios terms might have Then III scenario, based follow-up. what terms latest of curious, your assumptions, study that have might I in thoughts in your the the X out what outcomes. -- one is be? on the be

George Elston

measures? Are you talking about that... Is the on BCVA

Yale Jen

all Right. From minus X. X.X the to way

Jay Duker

we we can they a of as change II XXX If you predict size the the or package, land we've Phase can't -- we're actually, they done less, X that. that the where -- XXX the statistics of mean it worse outcomes, patients. as But minus trials. EYLEA control we're of trials few could so, without our that and Yale, than the do visual involve deviation certainly in X if standard of and those and deviation what may, the might letter standard run I pivotal knowing interpretation into for the might outcomes to might acuity, is

that So a it's because patient deviation XXX, patients certain deviation standard consideration, end is only trials XXX, But there's standard number doing I not the that's when fluid you're safety. of those because yet.But second patients don't the trials. know FDA larger, doing the companies think, for these XXX we up requires most for treatment-naive a of because results when

X-year dose don't or dose you're and to your to submit. have XXX approximately higher. at data your need X-year your patients treated of you higher efficacy you trial, patients FDA second the with with you safety or go-to-market need Ultimately, able XXX But go-to-market X-year, submit that So to treated safety. requires submit with need a the you for

pivotals trial.And X:X:X higher reach do those safety in consideration the would of measures smaller So dose a that would to end that patients allow maybe statistics number. not suggest a for the that's and the that have randomization the another we in the more might knowing

said already, and all pivotal As is to are in our safely the how to as view I've do going this expensive as as possible. options less view is derisked that's we quickly, as And trials. the

Yale Jen

the Okay. the you in least Phase of terms details retreatment a elaborate bit that? any that earlier helpful. mentioned the Great. very III That's more options incorporates also at on very, what you And you cost. or proposed, little Could retreatment, the

Jay Duker

very we've -- of that done Thanks. we enough have the and a been in Yes. earlier show X though these approximately than inserts. the number And vorolanib will even in to and I for think we studies we're very toxicity from area Sure. consistent release that, vitro been tox that start. we've inserts reinject we've therapeutic for EYP-XXXX if of Even vivo in safe evidence levels months,

eyes. with have of fact, not maximally animal level the we found In vorolanib tolerated

X/X because made the of a X specialists they to. the had what our of I want remember, perspective, retina every we eyes they drugs without want. want We're a in while think year months months? from we So safety to to should often than it longer to can choose it's in choose eyes dose a go it's X going our want dose give -- flexibility Phase X That's for problem.Why did rather, They we to pivotal that when doctors clear And flexibility I some that trial it's supplement. simple. not them. label dose months, the

Yale Jen

depends? That's just consider or regarding was add guys one maybe from And this news Okay. still morning, competitor's also something Great. more spots that the you that helpful. it

Jay Duker

Yale, again, but I'll address reiterate. I think this earlier, I did

companies' way the we've the If plan. proceed, that's to FDA great our from an is X. there see fastest, to any DAVIO may We what it's that. we at studying be from we'll Obviously, us. And dependent is with to approach, are least if acceptable for nothing trials. for pivotal point alter that we this there risky on seen other in be have believe that's But good learnings writing data agreement to that protocol learnings have that our an and

So comfortable to more, reiterate is details any really on make right once very are program until I we at can't our out, where are the with except that, comment now.

Yale Jen

on Okay. and Great. And forward early progress in the look congrats other December.

Operator

the Wainwright of & question H.C. of from Chen next Your comes line Yi Company.

Yi Chen

part a you Phase seems treatment-naive that mean EYP-XXXX EYP-XXXX could maintenance as to Does positioning the mean, while future? for by their your well? patients is in question market target you I lose of in patients therapy, my trial. could use the as treatment-naive potentially So III competitor

Jay Duker

think any it a get maintenance effective induction induction knowing if think or doses induction dose.Will it So use and first the follow therapy initially, be in anti-VEGF, that, let's be after we're some effective we cases. it If EYP-XXXX I that the doctors use I why after think includes say, hypothetically, retina try be the I the way. earlier way do, with data that community it's label for to argument safe, or I used the induction shown needs than specialist therapy a not and will I EYLEA label after tolerable, think of as doctors might second X solo

expectation a clear hope the was reinjection one for things. once just pivotal we wanted about we that of on test So And The the a we trials. needed things and months the reinjection. in again, reinjection, if we to a of lot depends the for market every is would label FDA label X get share was And again, talked reinjection.

that reads And label our is so way an I eventually, also. I think that advantage the will have if that think

again, So it's community at that But very And favor approach retina the we're we are certainly comfortable And we've will in I to, the of our we label, think it hard the we're once figure taking. think that talked out. where if approach taking. that. retina and I that to that program is with admit is predict. get specialists would I

George Elston

our market. and portion vast that every previously on we Yes. the patients and are majority a meaningful think keep significant we're just months our going X maybe opportunity to about if redose in think fact will addressing ultimately, that, And market very market physicians billion-plus going add treated able is mind, And is we be to $XX Yi, as to of of be the to I label. the have I the approach, use sooner. to But the a approach it can

our So with pathway. we're comfortable

Jay Duker

I specialist was a point for more, has their could a excellent retina made an one That about patient, you probably And add every practice. dozen patients newly diagnosed previously more George. or in treated

lot So once trial, of and filling why approval. and newly to question? Colleen and again, this we maintenance that's from diagnosed, one line Is there there's ask a a more to the out could see we've wants speed there is many a on chosen patients still recruitment than is speed if pathway, perspective a the reasons therapy from -- to

George Elston

calls she's Yes, a she responded, having morning. issues on of number this

find we'll So later. her

Jay Duker

Right.

Operator

this don't All actually we any the have time. And questions in right. at queue further

conclude conference. This and your does today's in participating program. for you thank your webcast gentlemen, and ladies So

You great now may a day. disconnect. have Everyone

Jay Duker

Thanks, everybody.

EyePoint Pharmaceuticals (EYPT) 1 Nov 232023 Q3 Earnings call transcript