KOD - Earnings call transcript Q4 2023

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Operator

Good day, and thank you for standing by. Welcome to the Kodiak Sciences' business update webcast and conference call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, John Borgeson, Chief Financial Officer. Please go ahead.

John Borgeson

our at and Kodiak. joining recent to for updates business you conference webcast call discuss Thank I'm Borgeson, John Kodiak's Chief Financial Officer.

outlined and events statements call the as CEO. Victor? will to not forward-looking new SEC. update Perlroth, with end are over portion are Kodiak's along Vice presentation a about And does other read An we will slide subject event that and are on year the be Research portion of on result today statements Pablo forward-looking the these that encourage to the call remarks, I can otherwise.Now this this that we whether this of future me Victor note complete access call to on material XXXX, presentation its Media Kodiak The to slide. Kodiak's and so to has open wish to information, after on Those who will do of and Chairman call. risks Joining and the which like any the on webcast including you also or Q&A. pleased CEO, publicly we for call be XX-K to Velazquez-Martin, uncertainties A will Exchange Senior during section remind may with XX, Development.After Kodiak contains those phone filed Securities description President today the refer webcast turn found carefully. website.We'd Victor and shortly Clinical available of undertake obligation the more this the which to archive you includes of for and on our made of I'm December any following filings Investors our that prepared been our risks Perlroth, website. and a Commission, slide this the of remarks

Victor Perlroth

and look fine-tuning also sector another room player and therefore providing medicines some have at years with we XX-plus We and our us. of around financial is innovation, a valuable. corrections meaningful The to read in are this questions to dominant challenging point of going-forward snapshot. listen atop concentrated to for business The Kodiak, of the trust will to morning, Good goal Kodiak's being a you, recent discussion players. in I to There's for color announcing our patients Thanks an the the you your retina-focused are major make we and Regeneron remains a release is aspiration. that should today's company, John. the departure for afternoon, of get with have ABC our everyone. welcome you and at are the forward needed line in our our is time recent Retina many able context to and only focus be At but we for courage joining finish to as motion. Thank press course with our Roche that end.We're sit view.Today area dedication. Platform of us to together additional and of important provide our plan. company. increasing there most activities And we and for return updates broad

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or and frankly I'm for enough say, for you today, you For smart Platform deliver that know can Kodiak's listening not whether not. to a disruptive some ABC investors represents may of innovation patients

for building for a the meantime, some alone. you. whether a also believers They say or are in Platform. durability key recognize medicines the potency But retina, patients remains branded basis KSI-XXX or unmet big believe ABC on treatment-naive mother of Platform we're stage want Platform. represents investigational we of is our highly fluid. this But in as the already be show KSI-XXX you context but itself the the need molecule provide at inception protein. Why?Durability potent let a maintenance powerful you as In for market and program regimen, an you, the that inflammation as without it sacrificing a and our And opportunity. it the safety mechanisms as company don't drug does for clinical seen you investment with for durability in our the KSI-XXX greenfield to ABC want we test can all from patients in patients marketed and a important give same it bioactivity design, ourselves, sharing not tremendously our proud real to safety. For you trials, in residual of Kodiak immediacy, the call ABC the does and us opportunity We the have program X grandmother, to your treatment-experienced. being successful new potential, efficacy base and on of

demand in also science unique look market well.We when which given believe the design and agreed commercially, back we'd to of of these may the Our the retina KSI-XXX flowed a enhancements, changes has these given conduct. complexity, for we the synergy also have see, we'll while, performance study useful, studies or costs can for And KSI-XXX, the incremental what also and science there for call now commercial medicines a strong the material made per durability. underlying these amount programs and we've are the based KSI-XXX, bioconjugates, important X the believe then design is in of programs, we forward. clinical them utility clinical represent the these group. we commercialize material, material already data our and sufficient our our yes, meet like there marketplace.Taking and tarcocimab with prefilled level we we of run And a we our I the their significant And product additional view it going unique top Tarcocimab into moving there's studies the improve in implement the and enhance our syringe, now these medicines test. across their in rapid on low studies novel innovator to can as to we FDA in late-phase the these here the operational and that And the together. believe which bridge in design I these pace plan molecules plan same also additional the state-of-the-art the are forward to tarcocimab now is development X to manufactured think that adjustments and where proteins, even our product to be to go-to manufacturability time as grandmother former

runway. start meaningful of with are programs, X see position inflections where cash when Let's we an intention attractive our Number QX. we Number today? we bring is where overview an are. a three, look we today within from cash So late-phase these and to X to one, at of we our programs two, number as position, cash have Kodiak,

tarcocimab in and retinopathy, we have AMD. for been vein diabetic occlusion retinal Phase in studies completed wet have So III X in that positive

favorable across durability We safety the seen have program. and strong and consistent pivotal X-month signal

planned away and plan uncoupled to advance durability been positive for KSI-XXX other go-to-market for the our is AMD commercial DAYBREAK registration that's and and the many studies. The enhanced edema, We diabetic where informed actively of bring year.Turning We've met is for that and for recruiting extra study advanced the KSI-XXX of KSI-XXX inflammation. GLOWX on we're to we've Phase competitive associated in for safety mechanisms patient from from And in potential bolster opportunities is validate prevalence pivotal it success of patients. dual is alignment strategy retinopathy benefits. the in which study. to position DME also conducted let's quarter Phase DAYBREAK formulation. enrollment added studies rapidly X to in development. And okay, to pivotal outside greenfield alignment tarcocimab established to filing finalizing Phase population in AMD an will of our into a into demonstrated the anti-VEGF bear. we're with created to process trial achieved design same on FDA see with developing the the wet a the developing diabetic and FDA planned risks Phase gaining manufacturing from recruiting midyear. tarcocimab's a GLOWX will process of we're Phase efficacy with high the regulatory ex-U.S. We're The in trial showed in We regulatory of rapidly the And and GLOWX and studies, second new support our diseases, and now GLOWX or strengthen start the IIb/III durability it this this our in and a objectives, III retinal our Platform tarcocimab's arm dose the study initiation program scale a now pivotal At our time, signals study vascular Ib X, then X and wet patients. okay. design from levels we macular have X already area, opportunity dossier.For the as I clear KSI-XXX of gaining and identify to an diversified, Phase into targeting molecules.A class bridging ABC Slide XXX, alignment say retinopathy tarcocimab I actively study towards in are be we're progress And program, additional further formulation III And in win a on successful the scenario. year. tarcocimab our as study most up our

is discussion to DAYBREAK study AMD soon as FDA of are alignment wet it We plan mid-XXXX. Phase design the on initiate in as regulatory the achieved, and study targeting in the with III

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BLA new X to abroad and KSI-XXX, is a X for powerful ongoing pivotal Our half for later X this powerful KSI-XXX programs. tarcocimab, the what's service goal BLA.Turning service and for X and of BLA have Slide year X. is in needed X to across studies

bring in among X retinal to turn by that patients all we pivotal their DR Now every tarcocimab studies, disease an vein majority of of any primary to importantly, first GLOWX Tarcocimab to can in tarcocimab ABC clinical X head-to-head diseases endpoints retinopathy, has the X behind it.In BEACON we It time can not there is individualized the aflibercept is get across let's month patients RVO durability the were and the and the tarcocimab future our program, occlusion And on current half months treat patients scores dosing bring studied for patients. we of diabetic X about view That's most X and studied could same anti-VEGFs been Platform vein study, In that about of of which durability. without our X third retinal aflibercept-treated was X-month biopolymer demonstrated study demonstrated dosing built second therapy compared antibody leaving month therapy dosing vision-threatening is to across XX%. reducing second extended months a met in diabetic standard My complications retinopathy, versus medicine tarcocimab-treated maintenance AMD. of once tarcocimab. severity study against the the which dosing. in to our irrespective the the anti-VEGF provide disease improving risk on a the by or the severity. ABC conjugate of of advanced the an in occlusion, in patients indications, can successfully as regimen.Approximately patients care, tarcocimab see and injection-free as monthly initiating wet

tarcocimab meaningfully X comparable in achieved vision patients, tarcocimab versus X point aflibercept-treated are fewer Over program outcomes met was comes departure These you of when demonstrated studies important intensive a primary treatment, its in wet to AMD, X.Lastly, with finish value DAYLIGHT tarcocimab year big dosing monthly things. indications. the anatomic study Nonetheless of our well-tolerated. are patients injections in entire and of our and they endpoints in safe compared tarcocimab-treated the and that

X we as successful So as probability a additional of market feedback that successful I perceived success. already and have to for to III of also, the very enrolling a have that improve FDA FDA in of the that more also study received pivotal of end, enhance is having plan product. Slide builds using today clinical new high tarcocimab X, probability not And GLOWX. to mentioned, and not market bridge X to adjustments go-to scale and different made in have of we studies, the the file go-to the product the pivotal of the formulation diabetic to utility retinopathy actively it may for in sufficient to evaluate, material real in turning idea market study. tarcocimab GLOWX manufacturability have we to indications -- of patients. will our the design GLOWX formulation, design material, and X material market X We've in I behind to DAYBREAK is GLOWX just study need and go-to GLOWX go-to Phase to the X studies it our III Phase X the but AMD. we high study bridge study from bring to just these study approval.We the as obtained positive diseases, Therefore see wet feedback on success tarcocimab And The was study

to think and wet So, DAYBREAK don't to see addition, consideration, arm investigational to X tarcocimab need investor results wait confidence.In with purposes. our around study an I intend second in you much some also we to study standpoint, early the a as after from AMD have

conclusively wet demonstrate tarcocimab's in to AMD. First, durability

as importance bolster competitive study GLOWX ex-U.S. market. the DAYBREAK process the highlighted mid-XXXX.Turning believe regimen endpoint benefit AMD package. Slide the GLOWX third of to primary builds and proportion week regulatory flexibility as steps [indiscernible] on of dose greater X is of of the the as obtaining at on We're X X monthly Second, position tarcocimab's the in study patients anti-VEGF improvement nice have on provides to part a We dossier. that monthly greater and to to same The initiate strengthen study design our third, the the loading is BLA And feedback FDA to to slide. XX. from with dose in design the loading tarcocimab's GLOWX.Turning given at successful of XX, to wet Slide recruitment X. with of DRSS The hope week or

ABC pathophysiology cytokine It is well first-in-class IL-X in is inhibits and as tiers of diseases. bispecific known turn of to X designed antibody RVO. both is upregulating our to innovation. stimulate with is XXX and is in with defective resistance second implicated let's biopolymer Now and conjugate KSI-XXX, or angiogenesis retinal both AMD, by factor associated treatment VEGF disease IL-X progression by investigational growth VEGF medicine. VEGF. It as a DR vascular pro-inflammatory and that independent pathways. XXX anti-VEGF a

of the month ABC And IL-X dominant Two, enhanced and from commercial X-target the the tiers unmet a Kodiak's the to for for address retinal KSI-XXX First, high-prevalence the and need platform. position potently as vascular in mechanism beyond needs X, disease both formulation X VEGF diseases X believe derivative. informed potential inhibiting KSI-XXX based VEGF We inflammation on an pathway mechanisms tarcocimab's need the the scale. such pathway. innovation durability extended to target manufacturing well

the beyond I manufacturing, mentioned ABC and is variability As operational disease a to in planning, fine-tuning reminder forward, and the additional the program XX-plus a XX. the therapies. anti-VEGF standard of over of fast result to to the our bring agents is today's This itself KSI-XXX response need the the therefore expertise.Turning and substantial the VEGF of of Slide And program care into the slide mechanisms the years. above, design, company is our past the clinical Platform

before, Both innovation into address mentioned action, and study to bispecific XXX per in vision native subject a mg. Phase Phase from it own pretreated months with trans to efficacy, go-to-market will in of so generated look on in DAYBREAK its to positions we and The KSI-XXX Each signals the of more and/or AMD into results, rather compared aflibercept clinical X tarcocimab for to both Slide this molecules to of study, study strong for XX further in to conducted pleased wet clinical respectively. including the treatment-naive variability to targets binds X durability that reactivations. retinal small a AMD in DME inhibit this their A was and label. AMD receptors substantial XXX safety Phase the XX. patients to the protein the our allowed evaluate a tolerability KSI-XXX.Turning in are that normalizes in blood study signals the enhanced substantial the which and reductions anti-VEGF in also XX, Ia, should is were potently inter-patient was mimics ABC and terms responses, inhibiting I is we prefilled later X and now of use Slide formulations KSI-XXX, as suggest in also CST study improvement DME proportion XXX action. As to over-interpret both in in can the us pivotal signaling XX, complete. of extended blocks enhance IL-X year. IL-X-mediated dosed the to wet X the the inflammation ascending by believe reduction. studied and multiple be this in visual demonstrated which but wet neovascularization, in where important period. needs try the bioactivity see I. every unmet Though study wounds the manufacturability has patient patients study XX dose that we evidence Slide designed a essential levels monotherapy, mechanisms trap evaluate weeks, not believe growth can of potential the size, activation patients. sample mediating and pathogenesis meaningful and advance of the could The effects. XXX soluble for X the the from dosed syringe We're the It response Inhibition for highlights treatment-naive study and gains And I be program.Turning namely treatment I wet barriers.Turning formulation the the is durability, regimen results play will in XX, both factor. meaningful patients, and immune the be well unique may driving There of dosing antibody in safety anti-IL-X and while Phase monthly IL-X and The response or also study placental binds non-inferiority the and and fluid that disease binding patients and and abundant to a XX-week mean there anatomical a support received KSI-XXX III acuity KSI-XXX molecule X-tiered platform IL-X VEGFB anti-VEGF planning both study followed to here.Turning and were agents in monthly DAYBREAK DME development mg and IL-X products. patients. a the we called study both molecule membrane-bound we mechanism Phase for type based that sustained the results additional to doses IL-X, was Overall, therefore AMD.The We think also and Slide was of X preclinical to pretreated Ib to study with is need demonstrated KSI-XXX improve and VEGF over we dose to that underperform of safe VEGF-trap choroidal will X be both for disease design in enables The receptor X demonstrated against role acuity data you Phase therapeutic well-tolerated. a in an dimers tarcocimab this intended simultaneously. of VEGF terms KSI-XXX of and portion tarcocimab VEGFA, The aflibercept the weeks, anti repeated utility multiple VEGFX, IL-X role on IL-X visual bispecific

turn as immunomodulators. the the are in Slide approved in dose pivotals. treatment anti-TNF biologic with that's also achieved, study efficacy therapy mid-XXXX.Turning edema, the for as therapies to administered obtain We XX, as Slide alignment treatments to and today.Turning to inflammation conversation currently disease is and X have biologic dose year quarter is feedback now efficacy generally the initiate intend FDA retinal for on to both our today us the attention into soon established independent we'll biologic Phase the designed to outside into and intravitreal the anti is Ib patients serious market anti-inflammatory our exist as the an believe the same to edema enrollment macular market. approved and This side such difficult potency are DAYBREAK diseases of Platform uncoupled Slide branded to mentioned but is unique advance retinal we is therapies the XX. and previously. change edema side therapy which trap only strength it identify target anti-VEGF levels platform, for IL-X greenfield area no uveitic to KSI-XXX. is protein safe, third which features of with associated plan design and with There a Treatment on We it for development no as systemically, conditions, prime bispecific, This which investigational diversification. a this unconjugated KSI-XXX medicine progress intravitreal VEGF treatment its also intravitreal KSI-XXX action, opportunity presents undesirable We portion a of second we limited finding to of at and and powerful, KSI-XXX XXX with on study serious formulation disease paradigm.Turning what risks and milligrams a alpha associated X our ml, in biologic per With with and this from limited for healthy focuses powerful that opportunities this that targets high complex from a effective we the macular Current medicine effects.There underlying are show call is with is in hallmark high is ABC many adalimumab, to inflammation, the mechanism XX. effects. is its that in steroids a is potentially non-specific exploring and it agent as mechanisms. targeting

X are for to process currently with pivotal In for in and summary, and with on to advance up XXXX dual plan FDA program Phase the X of IIb/III as III KSI-XXX here the pivotals and enrolling XXXX.Turning initiate obtaining our and tarcocimab XX design of We GLOWX clinical feedback of be in later summarizing. the tarcocimab well on hope programs for bringing studies studies plan. in as already Slide to our next KSI-XXX X pivotal then Phase KSI-XXX DAYBREAK we're into in excited forward to molecules,

within are have inflection analysts point to departure focused we BLA-facing runway.Now will points Operator? on value in cash we're floor and for at We current open a meaningful of III Phase our questions. motion our delivering and the we eyes

Operator

[Operator Instructions] And of our from first Jefferies. question comes the Yee line Michael from

Jiajun Wen

KSI-XXX of at the is Yee. questions for that patients be they have wonder to the for the the as of Jiajun that as from question the bispecific to you line data XXX multiple for given day plan noticed pivotal Michael you in part, BLA arms those if your filing the dosing? tarcocimab? well study arms or if and pivotal is, needed what's sample tarcocimab X treated And I of there Wen each beginning include second I This the would more size? same be the clarify I regarding study. the flexibility are on can phase study. estimate the of XXX randomized in -- would and And

Victor Perlroth

to to sure arms aflibercept the we and study as study, try is tarcocimab a that as DAYBREAK comparator planned and around for well it's include as question make understood KSI-XXX. include then to to Thanks, the that

data the objective in experimental also first So is But from in included including efficient of arm study an economically study it's with operationally. tarcocimab. will, for yes, filing the us the and very the BLA the tarcocimab for be

the to study those and GLOWX So and same keep timing at the for finish study time the the approximately our on DAYBREAK objective the to of studies are same also BLA.

that's the that make in FDA element. So get Then our an still the we design important study DAYBREAK, that sure meets we're with study for discussions on needs. to to

Our X-month the to from monthly tarcocimab through but objective both also and dosing and be of KSI-XXX go is able durability. standpoint the dosing power to to showcase from powerful ABC medicines be way our immediacy, include to of the durability all to for their able Platform

Jiajun Wen

that big for that essentially does well that as arms and requires XXX multiple So, you would to of have tarcocimab as a study mean you run?

Victor Perlroth

We haven't study precise disclosed the design yet. of the

you know, evolving. landscape within is the As regulatory ophthalmology,

study retina. our substantial studies has it'd many cost-effective. in core of be DAYBREAK a One objectives for Kodiak experience amount the diseases that of running is big of these in the

than to try we objectives. going be achieve have able so to not to groups to And to more need have obviously our like we're

where let's come So see the out tuned and we design. on stay study

Operator

line question Evercore next ISI. come from DiFiore will our of And from Michael

Michael DiFiore

And the is from formulation to follow-up DAYBREAK KSI-XXX finalized, in any used. used trial. color regarding could me. that currently being what is A will prior is one, how design be Number if provide a question dose I III formulation follow-up. study? few the Phase the different know from the the questions you have enhanced And a but I upcoming on I Phase recent DNA

Victor Perlroth

study, For use the microliter similar volume. a XXX the DAYBREAK plan to is

the formulations therefore, will driven So it be the themselves. of strength formulation by

their from with are used KSI-XXX be pivotal each does what milligrams XXX program so in formulation adjustments mentioned, KSI-XXX. formulation, go-to-market each. what of or I commercial what call also include tarcocimab as microliters, and for ml per XX both kind for one we pivotal the there'll formulations in tested in Phase scale-up this we've our which, program strength previously was the the was molecules And tarcocimab at So mg be will X and of those

these to next as said, be step important these to able what we're set at So of these enhanced with pivotals. of into I molecules point departure and and studies adjusted can in showcase an formulations, new excited we're do as we these

Michael DiFiore

my Got is the correct trial. want Got is exactly on Kodiak helpful. order to an question dosing this being to that I to in have And the active it is, guess it. just is assume Is proactively tarcocimab I clarify added flexibility why the DAYBREAK this doing as That's in requiring that and label? FDA it. follow-up comparator not

Victor Perlroth

one We I work be. And lean to anti-VEGFs. wet for to in say figure to right, into us some that we what additional AMD the hand, to with the wanted represents tarcocimab do And our market, really out finish part a the months struggled the to took program. it on what somewhat we would large of because plan wanted

the other study let's want on the different hand, we the to were stakeholders so say, about success of we investors hanging or have outcome. probability where, because On run worried didn't much the

an we we into study in the was in would in run wanted success for the which pivotal that same decided the for group the we successful a we as run as that will study for study can -- outcome. GLOWX, core given to to tuck And additional which end, then, addition, a very tremendously have of we our high which essentially study KSI-XXX. GLOWX So approval decided probability tarcocimab it's

with to to tarcocimab. decided successful first we we're we'll pivotal checking up efficient hope, a tarcocimab. in study, run hope will successful having then wet study at studies will for study economically, end study and BLA. X DAYBREAK studies that we the So KSI-XXX, our very for additional cash for box its tuck pivotal X And a to include the study be it's the need it time, And same DAYLIGHT overall successful, for file a we'll AMD as then in, and also that that the as package

So in pivotal of right, if we're bringing call program about run all next the with you the starting X with several I development. that's them late-phase think what Kodiak's Kodiak's being molecules, philosophy studies of imminently, to years that

Operator

our will Anupam of question from JPMorgan. from next line And come Rama

Unknown Analyst

for Anupam. actually This Malcolm is an on

milestones So now being end into X What from us. between terms the your of XXXX? assumed just and in is -- runway of cash your

Victor Perlroth

design on the FDA in Phase as to for translate with the as as Well, and the that certainly, studies that the the well. studies and they out XXX we'll on how pivotal. a hopeful pivotals of depending in of tarcocimab be X into we're enrollment, the completion And we're completion those XXX those well timeframe IIb/III little get designs discussions able of currently bit

Operator

Sachs. line Tan the from from of comes question Goldman Andrea next Our

Andrea Tan

plus for remains as recognizing us, X Maybe the that to the the of between what -- have, follow-up you maybe you comment, now carry formulation that that durability or you've formulations as of share data to to what original X the a transition supports conjugate potency that antibody? you will biopolymer prior mix a the a please. conjugate can over seen speak same the from X

Victor Perlroth

strongly conjugate Thanks, the Andrea. believe Well, that's a patients good amount than more durability drives question. broadly we variability in of disease more what We is that have. that

of X.X in we mgs and durability study, X So, Ib that tested and very for there's between versus saw we little the Phase fully our X.X milligram X example, dose. material, milligram in mgs conjugated the the distinction dose

the tarcocimab of KSI-XXX formulations powerful on margin without patients. free level the the we and we of bring bring worlds both durability the of protein, believe both we down to creating the and conjugate impacting amount a a for broader can best as into allow medicine that So

Andrea Tan

trial Got AMD? data it. about gives directly Phase I you XX in quickly what have now XX just more a maybe the Phase the wet X I. that share in you speak III then -- DME patients seen to that to the on the from patients a little bit from for confidence the in And move Could you Phase just

Victor Perlroth

Well, that's a good question.

as of important with in vision terms I the bioactivity across the and and retinal about study well with to The safety given vascular agents, departure diseases to overlap gauge idea DME where OCT. of existing into predictable in And Phase of the can different diseases. as see broad number of gauge responses was you point then and KSI-XXX the that starting the and kind point of bioactivity of as a the safety any using

wet suboptimal of mechanism wet VEGF best-in-class reactivation on the I AMD, So Phase known action, I based culprit confidence of right, the inhibition KSI-XXX of III in is IL-X, the into also and in AMD. where to dual the from I mean, give which the with of profile move mean X disease response target reasons durability platform; us two, a the is one, and that Phase directly we trap

enhanced the clinical we clinical in-human clinical of in experience formulation. our studies XX X them years pivotal. first and the And X is phase, operational manufacturing Third that the have, INDs, X in X four, the design, the of the molecules X the trials,

So be in well. may we're in DME as not future, starting KSI-XXX view from scratch of here. And we furthermore, exploring in our thinking the

Operator

from will of line come Gena Barclays. question Wang the next from our And

Huidong Wang

current versus based try between III to DAYBREAK, an is you believe independent running study clinical power data, design for benefit will tarcocimab? XXX Victor, show you than being Phase to is a question tarcocimab? related to for a tarcocimab, than way other in the do differences avoid XXX And better on to cost-effective

Victor Perlroth

question XXX distinction amount to for It's in And agents power trend that we're between don't tarcocimab. twice a agent. DAYBREAK. I see and XXX mean was that and the And anti-VEGF to to for XXX physicians an better pivotal. that why and than get than as physicians is program our of whether those for important tuck-in needs how AMD, just a objective by tarcocimab be don't better other. the positive the XXX, going year useful our maybe or to patient is because or the the in own pushed we if tarcocimab, opportunity let's a not tarcocimab than There's second going see need majority study it's in better I with over say, whether creating of think the it showed we're very tarcocimab in running clearly a it's group GLOWX agent some obsoleting we line. X data there And having aflibercept finish wet DAYBREAK it. for, like

profile, think important be so mean, a that we to primary hope, on And to molecule would both both it's and do market. endpoint, a I meet right, molecules the it showing what could useful point problem to the be a XXX such they enter path have. at differentiated and and we it's tarcocimab a that that durability that start as if perform we would delighted be

Operator

question next Ellie line will of Merle UBS. comes Our the from from

Unknown Analyst

questions. context or inflammation like do where inflammation of had first, And Sam on IL-X is Ellie. where how do particularly second then you guess, just think X I I'll It's my this is ask after. you think We for relevant the IL-X in space? about

Victor Perlroth

Well, inflammation the opportunities, that area macular I of that into we we believe the the edema believe of what high-prevalence and that it's relevant of the believe we the represent really think us greenfield right? complex. why strong And So be molecules different sort to we is broadly market, uveitic protein which develop highly and to that's anti-VEGF highly have relevant, are to it's or we and have mechanisms allows should different very on both that have the high call a a at a outside X those diseases alone, KSI-XXX formulation within able sledgehammer, of X potent both into X immediacy. strength, them, that

IL-X So, we're the inflation. those excited edema a the patients in in macular driving driving about important that. And role also plays obviously very in and

important diseases, role. inflammation retinal an clearly plays vascular the Within

in what explore patients. is elements DME, subgroup driving what wet large want show the play think lack large efficacy trying pivotal say, of subgroups or development, you of necessary within around for the studies, II you where when efficacy inflammation within the and program or several to is I about AMD, a right, the years question that to in drug to Phase though, think what right, do those in

to So the smaller to what to in improved able with or be run work to in mechanism. be based get studies parallel planning different and we these in drive and to some setting of a those the of to the studies drug do on molecules the the molecule II to we're studies non-inferiority don't that the is efficacy. inflammation rather or we need to take do physicians setting. investigator-sponsored level noninferiority pivotals approach, our high We that in or special show able indications for approval either approved expertise can to in think running work in Phase then with contribution But to the patients than postapproval really tie then showcase

Huidong Wang

Makes then a And quick Great. a sense. of lot just follow-up.

then and XX to DAYBREAK, use on according FDA guidance to What X For active the regimen mentioned recent XXX every the weeks aflibercept your dosing dosing in comparator? of like draft terms with you frequency dosing the comparable is dosing label. of the regarding perspective

Victor Perlroth

that's a good Well, Yes. question.

will driven and study successfully necessary. And based we from the has with of terms design of now And looking back, I but in other stage, have constant pivotals It's design really up. specifics. be FDA innovation we'll that's for all communication kind in programs. we're in the we feedback study clinical with the And to where been our we've once think confirm share FDA. at this for agency our Kodiak the for I study historically, X of and say, for to information final all design example. the on discussion, needless companies want have the within see think all we we'll ourselves followed end all do

Operator

line of Daniil comes [Operator our from question Instructions] the from next And Gataulin Chardan.

Daniil Gataulin

I have X wet on XXX AMD. in

regards second study? first And DAYBREAK you time from for to tarcocimab? Specifically on will initiating plan starting lines are you that Or before that the you as guiding when -- include of second pivotal study, tarcocimab plan trial? also data generate do for the any

Pablo Velazquez-Martin

we Yes, a X between we have have and don't in haven't we plan haven't sequential until don't we for we its -- the for that X We that studies. is we case, we XXX approval but complete for disclosed it AMD. -- or plan have -- we that of somewhat disclosed we thought haven't overlapped -- haven't second need know the study a wet of

Daniil Gataulin

are customer consequences the have in it. the quick a And if what another succeed do potential I question DAYBREAK study? think does Got not on you

Victor Perlroth

of monthly, having dose on a in results decided can important by medicine guess that for Well, that group than just DAYBREAK. we've relying study with believe the we that tarcocimab full demonstrate it patients AMD. to an makes I the we rather where But wet be sense DAYLIGHT

the feel excited wet get to indication. So, if it physicians the able use approval X maybe having would to not then unsuccessful on we in we in or meet DAYBREAK endpoint presumably in didn't based studies wet AMD, might be in AMD not

can We're substantial making. and AMD we're wet we really that in and optimistic bet think be demand a represents tarcocimab it important. So for drive it

also the lessons study suppose, of the adjustments review detailed also having educated so on into I to some but in is run DAYBREAK the that and one it's material our, So way, far. we've X that's pivotal or learned a tarcocimab expertise data gamble, introducing go-to-market made based from our our and

that So we're hopefully see really it can we excited with the to powerful. to and run share to include DAYBREAK data and to tarcocimab community the and and be that in think

Operator

any it question remarks. back showing now Perlroth, not I'm CEO, this any like would further at Victor our closing turn And you. Thank to for to time. I

Victor Perlroth

forward forward and very think done. of of so people new look all finalize and Thanks much. Thanks. this we much. our information, information Kodiak to plans designs look about We digesting study the them. I as to on steps we're especially the Thanks new next

Operator

participation conference. in does Thank program. today's your for the you conclude This

You have may great Everyone, disconnect. now a day.

Kodiak Sciences (KOD) 28 Mar 242023 Q4 Earnings call transcript