Kodiak Sciences (KOD) 13 May 202020 Q1 Earnings call transcript

Good afternoon and welcome to Kodiak Sciences First Quarter 2020 Business Highlights Conference Call and Webcast. My name is Chelsea, and I will facilitate the audio portion of today’s interactive broadcast. [Operator Instructions] At this time, I would like to turn the conference over to Mr. John Borgeson, CFO of Kodiak. Sir, please begin.

Kodiak highlights joining call. for you Sciences’ conference business Thank Chief I’m Kodiak’s Officer. John Borgeson, Financial

are Chairman Officer. Victor Jason today me Joining Perlroth, Medical and Ehrlich, and Officer Chief Development Chief and CEO,

our After remarks, call for Q&A. our analyst will reviewing to up prepared open business, updates the we

of of after contains slide who phone, section The refer access website. presentation the on will of available a the wish of Events of that presentation, webcast the webcast portion An during along this the in slide this we portion do to this Presentations archive call. this may so on call and Those our the call. following our will be website soon conclusion to

and description today XX-Q initiation, to for statements certain guidance, other and our include the with which Form filed Exchange business, financial I including business regulatory conduct trials, period activities, enrollment, these our risks forward-looking filings Commission, Kodiak’s found related Securities our remarks like would remind yesterday. matters. risks call you complete the regarding the to results and development strategies, was and that with the A our business of of and be research in clinical this SEC can March made other XXXX, XX ended more quarterly material on

result not does information, new of future a forward-looking undertake events as Kodiak any otherwise. whether obligation any to publicly statements, or update

to on Vision. impact will updates, COVID-XX we program, the During that discuss describe pivotal review XXXX KSI-XXX our operations, on the upgraded and provide execute our call we today, and program our of ongoing corporate clinical will meet how

the moments reviewing a detailed in to so would financials, this was like published our XX-Q to as discuss is position, discuss on few operational and yesterday. highlights, not to strength financial much While call our intended I take to of focus

and marketable in XXXX, in equivalents securities. the XXXX of of $XXX the over million efforts heels fundraising successful cash, we with On December ended our cash quarter first

During the includes net expenses a $XX.X first $X of million, loss quarter, of we posted which million. non-cash about

that runway into our current DAZZLE preparedness. a of operating extends aggressively estimate we pre-commercial execute the we readout far projections, factors, XXXX current dependent our our our How of be sufficient on to is study. to through cash number will on cash choose XXXX, top-line invest plans including including into how Based on in

As we our second key BLA the application XXXX retinal single to of we expect forward move million $XXX also with our royalty covering of a the indications, have from access transaction. Vision to tranche

will past review I Victor, quarter. this over now business will turn it highlights who from to

Thanks Thanks, business this the how wanted of joining John. afternoon, call impact. through hold progress including of and We its for terms be with pipeline, our discuss the clear development Good everybody. in highlights to for recent managing COVID-XX us first highlights the XXXX and to business we’re to quarter webcast.

diseases. to proud COVID-XX I’m patients all Kodiak and team our mission which community very Kodiak continues more and the the of pandemic, retinal our we dedication of of with as the employees, challenges our navigate deliver helping the serious of broadly, on team,

So seeing we’re to from disruption date, minimal COVID-XX.

clinical treat missed patient manufacturing to more in than visit clinical market. X%, Our operational. rates as less we’ll continue a a towards sites to to confidence study sites and labs and And the new the standpoint, the patients, DAZZLE, discuss enroll vote it’s and testament advance a to from patients. from serious are that are partnering a In here and well. at is detail, of proceeding Kodiak KSI-XXX proceeding are and diseases with This trial we’re we’re attempting who us physicians

was our monthly per past this mentioned, only burn-rate million quarter John As $X month. charges, non-cash removing

So we at remain strong footing. a on financial quarter-end, with equivalents very and cash over $XXX million in

pivotal studies and quarter. additional this we’ve planned KSI-XXX delay did set for for in We in we June/July planning pivotals today, first were of that as by to first-in-human of of shifted human KSI-XXX timeframe, year. timeframe Now, X now of September/October next the initiation the our the

not put business the time Kodiak’s working and manufacturing on impact in terms growth. the with phase with partners execution, upgrades X, program; this X, structure particular, pivotal or physicians there, to and the X, of using to possible just regulators of conduct, next relationships on with stage minimize structure best of our to our best and pivotal wisely, how clinical, assess and for acceleration our of to in of trial the companies, engage them clinical and optimize in to our to this study partner escalation we’re designs; Now, but, COVID-XX on

Importantly, filing for KSI-XXX, remains and intact. Jason the in we And the study taken disease key additional our this indications to pivotal Vision additional good mentioned, XXXX I time, discuss upgrade advantage detail. plan retinal towards quarter, in as of our more a that have BLA will

Retinopathy. and Edema, our multiple where conduct plan, Macular we Diabetic X earlier for in X X studies AMD, RVO, X and to RVO. X this had in proposed ongoing a study; In X X in study. Diabetic reasons and into though, And in DME now wet summary RVO Phase from study intend and DAZZLE our study study we There non-proliferative X X DME, shift are DME studies studies

execution be words, pipeline with new more the studies front, predictable. of to faster, more a plan, and the plan. the studies, DME the expect expect of we component predictable and the clin-ops and In On the simpler of this we operational other

prevalence, than resources the higher to in the an margin This into we in we’ll it’s of particularly the And COVID-XX, especially blindness be and important to which EU. predictability ex-U.S. simplification. in to disease DME, Further, unmet remains program higher run the of believe in light shift the fewer geographies. on U.S. cause prefer fewer in and leading able working-age also returns countries, and DME we the rather is adults sites, need of the studies research RVO. important

observations at consistent to year. this forward data on update Xb data Xb shared R&D look our we providing that will in that a meeting; goes person the in next And Phase clinicians, in either That American or February. that at to the Importantly, similar either our if through either continues virtually to in of remains the of Phase right, Retina in emerge through Society July we study partnered Specialists other the virtual, one with meeting, words, or Webex be of very this.

health I though, guidance we mentioned, as for employees March since work Operationally, and non-essential in in be And operational of we’ve California, a arrangements with State implemented the our CDC to taken line laboratories. the in safety remote protect the to employees continue Kodiak steps community. we’ve of company, and our as XX. Notably from

pause clinical could I’d like also over here through how to about managing new call ongoing to and the introduce Jason. KSI-XXX talk and study COVID-XX, we’re trials pivotal program? hand Jason, the you

over the clinical care compares joining in Well, Thanks Yeah, standard few Phase thanks, been which integrity in DAZZLE, Victor, is wet KSI-XXX patients RVO so KSI-XXX The team wet to our the that pivotal and data last both study, months, and for of DME, us. to focused and in aflibercept. with study AMD AMD; ongoing Xb our trials. everyone. has and on ensuring Kodiak good then afternoon patient safety

operations to ensure and ongoing planning, possible. So team safety study as execution we’ve really of made the as enhancements numerous study members help into and physicians, site patients, the much Kodiak staff

on, they actions of the the additional study budget rates, the specific transportation that’s providing of So increased study if monitoring, required remote study so to with attend comfortably we’ve temporarily overhead that can taken PPE and visits. additional and that use patients for the to appropriate procure sure the include and options help for studies site time make service safely some to

new have importantly, backup situation plans where enrollment at allows. the local place, and only in And study we’ve also sites been focusing that resource patient appropriate the COVID-XX

So study to we actively as really trial promptly as monitoring to And integrity participation. our sites, disruptions. with well safeguard vendors, respond such regulatory partners, we’ve potential the been our as can, CRO corporate logistics and as we’re the study authorities both being and as proactive ongoing

and missed very overall to happy to visits teams DAZZLE situation permanent and high visits as sense in the study of continue with by again, investigators say with the patients vision to retinal March And makes I’m to based continue local-COVID that the their new diseases trying treat of existing the risk to date, less loss presented few in in and undertaken light we’re be than U.S., and the well it our efforts do ongoing X% by as missed where April, patients team, KSI-XXX, that participate to in the our so. that’s on enrolled

see in by that seriousness by as diseases. staff and and Maybe recently. specialists studies continue to EMR also well patients those is published who some making retina Health that’s been color the others see additional collected that try on are Western pattern The we just data of to need anti-VEGF therapy, efforts and as reinforced our their that’s

have outpatient visits may over by that in seen and you declines ophthalmology down in retina the U.S. themselves of some patient in March April. XX% specialty and and March So clinics April, XX% early were visits overall saw in

those But were for anti-VEGF visits was substantially. the up that proportion of administration

meaning to and So they retina so. therapy do that the continue who patients specialists prioritizing need were anti-VEGF

difficult the for visits, highlights potentially this long-acting readily access to where real time, may as think help patients the outcomes between such office therapy keep become of therapy in setting over safe less can and I importance So this more frequent a KSI-XXX, it improve really world and in clinic particularly the pandemic. on

into The to therapy. XXXX, enthusiasm So investigators quarter of as patients the recruitment I and robust. enrolled unmet patients of XXX underscoring through part have reflection the on need and the May think as then the been X, then, for well of was on KSI-XXX study very most the back long-acting DAZZLE for DAZZLE as first into

patients that So DAZZLE U.S., currently, in saw compared to slower month enrollment the or into we not to patient intend and the seeing February do March. per are pause XX-plus but we in enrollment we screening

that sites example, necessary, site the to issued COVID or enrolled earlier. We patients As part if study to ones new pandemic. I encouraging enrolling staffing discussed participation measures prioritize the currently during over limitations for due of closures guidance of

the the And then around U.S. as and last Western U.S. DAZZLE that number And note in patient see new that the at data turn clinic weekly I screenings starting week increasing. of was that we that of is EHR sites late retina published in showing is volume in enrollment to April, the also

XXXX, we European first begin patient by of local in sites Europe. recruitment guided of of as do in we defer activities study the On due But now quarter to in the sites the again, in the certain then side, XXXX, Europe actually activated screening. we But quarter COVID-XX to have DAZZLE second the at expect the start pandemic, situation. patient

committee pleased with I’m the and without data And independent May DAZZLE, continue that to recommended early respect then DAZZLE finally, in monitoring modification. that met

is of the study IDMC the well group responsible know, their we’re trial monitoring interests and As participants, the assessing for study and safety as their And grateful you for during recommendation. safeguarding DAZZLE overall as support conduct.

pivotal our June So next of to or Victor of of and for progress of turning year In and the pivotal rest initiation mentioned, of July September the we of this the program. monitoring versus RVO the delay the and the the then COVID-XX as studies into DME October planned pandemic, impact timeframe. set KSI-XXX interest previously

delay evaluating NPDR the We’re due timeframe, two deferral delay pandemic one NPDR the can in the to DME of diagnosis same quarter study start, the study whether NPDR in follow-up the on – potential still expecting for we’re we without in a patients. and resulting the initiate to additional

a have than As with DME overall AMD, you wet patients those RVO. disease know, lower and patients severity

in more on a few minutes. this So

pandemic. to supply Additionally, our to activities manufacturing and that of don’t KSI-XXX And remain I’d chain anticipate currently note due supply we the our to disruptions like intact.

turn COVID-XX additional call John me away then, highlights. the back to through business from Moving John? go let some to recent

Jason. you, Thank

$XXX of X, of December you the future agreement XXXX. many for of million KSI-XXX we announced remember, As for an royalties may on sale

the first under on February XXXX. we the XXXX, of on first $XXX closed the quarter payment X, receiving million agreement, During

board commercial commercial of a Taiyin recently, with made last In of operations. was Vice and manufacturing our Taiyin leadership in also additions an quality The rounded brings already Charlie pharmaceutical, Charlie we experience be Yang, Chief experience at experience. of the serves like Dr. and months, to currently Pharmaceutical as supplement launch. addition Gilead and with Taiyin X in we’ve a financial and to at deep and Executive I’d accelerate will the say Manufacturing as of Directors. Board about Officer most several formerly a board strong Development Charlie instrumental BLA our with planning towards and brings and words that wealth combined and President BMS commercial and few Bancroft. of our Financial knowledge well deep

progress recently, establishing leader comment Patent for and I trademarks continued our use, a Lastly, received our as name treat our would to and portfolio. with our Kodiak registration like Sciences exclusive IP development of and Office to and the the prevent full Kodiak U.S. we Most in with of research Trademark quickly recognition diseases. on medicines retinal further

me let back further Jason clinical on highlights. turn that, With more to Jason? elaborate to

John. Thanks,

respect updated from Phase safety, trial with Generation that we data Xb back continue ongoing presented the X.X Xb study, anti-VEGF differentiated the KSI-XXX. the the So durability and highly of at data of to we Phase in February. And profile believe KSI-XXX Angiogenesis to support meeting efficacy

R&D we be anticipate virtual updates where Xb or continue will data if congresses Phase from the webinars COVID, canceled become would throughout to virtual, Now meetings to are presented. due or data we one plan and presenting more year, study new this or

The similar a Victor and turn generated in in next data durability we and to important ASRS a towards to up that beyond. Xb. at Xb we durability July, in collect we’re on occurs, how providing months, that will in as presentations start focus whether virtual either patients forward the as XX So with months And depending meeting to timeframe, to X follow-up Phase be or pleased on the continue the will. the those outcomes long-term is and R&D else webinar of the of Phase look if you mentioned, additional data R&D and the update meeting,

data the of over course with forward starting presentation with look upcoming you to the the year, July. sharing we those in So

treatment exposure also the I KSI-XXX, include outcomes XX Phase follow-up XXX we years feedback from to efficacy Phase to up furthermore desire again note additional pleased amended And patient total Phase then and to investigators, we’re Xb alone, be to continue data an generate further to on for with on per in seeing. of Xb, that profile of And safety safety based positive a and study program the a the patient of months continue and with XX approaching very the and Xb with KSI-XXX months. now we’re that long-term

So time on FDA diabetic subsequently, macular Victor the in our safety one to Phase AMD study program. DME. mutually-confirmatory meeting non-proliferative talk the the we study, pivotal studies initial and communications And X FDA about to without pivotal Phase following program, for end then to in studies conduct by pivotal KSI-XXX demonstration well occlusion efficacy, with of in the moving retinal we ongoing provide wet as X as as now and mentioned, the with required upgraded X edema one of and DAZZLE vein study then DR in of at further intend X

required commercial area additional successful the So for entire the program. by and opportunity, while efficacy we’re generate pivotal that’s number of conducting of need paired narrowing on safety, of countries sites studies DME, the and able in also to durability in KSI-XXX and this high data the unmet of enrollment

contributions sites potentially of the certain Israel. in So to U.S. located China, we with Europe, be in countries and from research the expect majority

DAZZLE missed rates that patient continued Given U.S. seeing the the currently enrollment, we’re low in new pandemic. visit and through in

one for our We and believe and pandemic XXXX towards will and number narrowing uncertainty refocusing DME needed help way might and during terms to of few the the studies, through that versus our participate RVO and needed reasons trial in include A to studies studies. logistical with for to supporting help of sites and X RVO cost X running respect KSI-XXX focus RVO fewer both DME paired in which specific us countries opposed conduct with sites only other really the pivotals, sites trial opening additional that will burdens minimize program of and be as countries the vision. the around, be

or wet better overall Next, execution running studies of patients can the I that naïve concurrently we’ll AMD, essentially have sites in were all enroll DME think oversight our operational and RVO. of

I of the more since sites probability disruptions scope think of a countries lower is and focused. we’ll time COVID-related over have

any a higher similar if versus then in DME studies execution to marginal given X As X unmet costs DME are and overall timeframes there’s RVO, compared Victor it’s for mentioned, increase a the in need RVOs. trial

higher to considerations, Xb top there, we’re data operational the as align compared Phase and in those And remain really quite of area we then, clinical that seeing to DME, clinical the pleased unmet DME study. of we large want of greater on in the with generation RVO. And the patients given the need data diabetic number

Now, been the asked why wet X it studies. X to plan, we’re DME a change we’ve pivotal to if AMD make going as make studies program opposed to

X think reasons. we DME studies’ a important for sense of And more couple makes

from X in perspective, the in is, margin DME, and it’s letters statistical comparison aflibercept, for narrower little to a in is whereas are AMD. bit standard a a non-inferiority letters narrower X.X First deviations DME a wet

when you AMD really substantial So Cost factor. require wet or course, add difference. driving more than the a is would fairly XXX an the least additional cost not, up, factor those be study study things now would driving DME patients at a only of

study, to especially I studies DME the in so so retina access we working think trial, can to happening losing we in COVID, where opportunity important, and When clinical to potentially quickly, X-year should at community the a environment. to of due the this quality care X recruit high participate that to with they have the a that’s people specialist, are deletion should in the and what’s so believe look – people unemployed many age healthcare, their that relatively access who also

patients, AMD quite And COVID-related almost highest the also really that complications. elderly at wet of or are they given risk

again, less makes the a sense. the are to think people those of focusing physician, X go lot studies So DME to the willing extent we on that to

note of the one acceleration back the call hand So bispecific then, quick finally I our other before on KSI-XXX program. Victor, to the conjugate

As novel patients explored may strategy a interleukin severe inducer as disease. a KSI-XXX and in well pathological And in dysfunction. vascular critical IL-X, being VEGF. remember, edema, COVID-XX play therapeutic IL-X VEGF inhibits with also potent you is lung as permeability a of both COVID-XX may is X as which blockade and role driven

mechanisms which simultaneously, fusion binds and high build the it OGXXXX, protein that some to its our product used is in of affinity candidate VEGF. And synergistic we targets So shows inhibition of IL-X KSI-XXX ophthalmology those bispecific vitro. both to both quite with

X months, protein, by advancing patients we’re OGXXXX worsening assessment the So GMP an systemically disease. administered in of with may OGXXXX enable for which the manufacturing COVID-XX

And for the material for of and ancillary benefits component. XXXX an submission IND vascular of in and include featuring GMP acceleration program more use a in bioconjugate the KSI-XXX the toxicology Human First retinal in patients with predictable KSI-XXX inflammatory disease timeline

I’ll wrap up get Victor and into we Q&A. now before back to So to remarks our

Yeah, X. be helpful think powered quickly, number each would reviewed the our clinical together we kind and Jason. program, KSI-XXX really Slide across plan And illustrated the program. work upgraded refined of study being portfolio I Thanks, if to protocols with including of as study it this the on as finalize And brings of the slide subjects in upgraded XX%-plus. we to

plan. top-line So the their treatment last this of and feeds obviously, and duration, the XXXX and for are BLA rough Slide – into data patient view a program overall in, studies, first clinical patient X timelines our parallel filing in current shows availability. strategy, And view the in

our on to bring Xb study, September, plans plan, much nice our the and So clinical pivotals the to then enroll, refinement to initiate like in and board in this DME ongoing, which parallel. hopefully, and NPDR it paired as the of we’d it’s study DAZZLE the see the continuing RVO to

clinical a happening next the guidance pandemic credibly year. in what’s QX, in be patients it come as QX the those But community’s the and/or able mentioned, we’re bring Jason of depend to going pandemic bit with during to terms on will into whether little of

Okay.

retinal So moving what sort call X we X, into Slide pillars of disease. of the vascular

educate Phase of finalize course As designs. program, study in to pivotal directly study guided continue design, X our designs by study Xb pivotal data, the we the and we’re which the Phase the

Xb Phase in very being the lending, KSI-XXX high addition and in pivotal degree we’re the So the confidence differentiate these in believe, a studies, primary of hit the generating on to of able durability. studies, data is to informing endpoints design we clearly to

profile, pivotal are interval sort alone our comparator, that these very of whitespace programs, diseases, study more obvious highly us and within these product real to EYLEA. even target right, with and treatment clear and can powerful the each So of further a call the of what we right, profile, differentiated each between shifting support Generation increasingly together one a X.X

So we’re the that we’ll through XXXX. in marketplace also entering be thinking

desired highly of differentiated Avastin injections capturing also upside actively supply but the the for patients we’re also of the agents, first assesses This capacity years a to KSI-XXX launch. opportunity manufacturing assessing profile, assessment the includes and as Given branded well. monthly

of pivotal a important look on that is bit a little data Take summary the product been look lock-in core with of X that’s for in That a us the at Vision KSI. non-inferiority the us of Slide of in the that program. in design protocols profile generated pivotals us Xb. And each X at some terms this So end up an as target a helps bit may primary indications and the these lets about our we data endpoint. of lets from think

complexity within each one the into that of believe And the a one we together each overall of on powerful as about core the pivotals think market into. that of come these And high in medicine durability, dropping is we probability we’re lends very indications. then, the of meaningful success which differentiation to very a profile,

apex single DME of with momentum indications pieces our captured plans pipeline Moving our for crux the X, slide. of parallel, breadth our really DR evaluating really wet can if in Slide be XXXX level to filed and XXXX, right NPDR studies The the for throughout. well, or and AMD, we of Vision into KSI-XXX, and reaches enthusiasm RVO, in an the this by potentially going are we’re for the a BLA with a get across efforts

about acceleration that increases thinking well, a obviously, the IND also utility Jason we of we’re for Phase an in this evaluation safety, patient first XXXX. type confidence manufacturing And sort KSI-XXX, to worked combined of that’s for but for our of mentioned, benefit because from quite hope and terms in study of KSI-XXX, in, Xa/Xb So the achieve molecules. which KSI-XXX to also

in we’re case, we’re together internally very seeing And AMD. for submitting we’re initially which interesting forward lastly, for KSI-XXX, our bringing dry this inhibitors, program with IND progress triplet also new in that an looking And towards XXXX.

on X, quite to Slide Moving achieved in we’ve XXXX. lot a

looking to XXXX, So additional we virtually of virtual expect at event. and that data as as present Kodiak data to we’ll excited mentioned, mentioned we or the of to the details be KSI-XXX, to durability from our hosted Phase durability Xb, ASRS present the we through,

to forward update. July looking data that we’re for So new

execute on execute readout. operations program to our study continue pivotal continue study AMD move activate that execution we’ll In patients study in the additional XXXX, to Xb DAZZLE ex-U.S. DAZZLE will and clinical from and in the indications. full with Phase data the And also and Europe report into on our pivotal wet KSI-XXX potential We our we’ll

detailed Furthermore, to prior is KSI-XXX the we advance seek we’ll company, clinic. obviously massive year a the slide. as XXXX into for in the

to XXXX then, geographies. top-line XXXX we’re big submit for commercialization that is key the indications. vision of in BLA pivotal KSI-XXX Our regulatory report study in readouts approvals and in single planning and In multiple

the we well remainder are open looking highlights – to business the and for part with the we’re very positioned our the We we’re So believe questions. of goals for second analysts in calendar in year first floor of summary, first Operator? the accomplishing quarter of the to quarter the pleased now We’ll XXXX. forward XXXX. for

Morgan. Instructions] And our Yes, question Anupam with from sir. first come [Operator will J.P. Rama

This for on questions. the is for Anupam. Hey, guys. Matt Thanks taking

development and done good with possible, to timelines for around Vision first much So being keep so intact there. as efficient well XXX so off, be agile as job

retinal trying to when guess, these is biosimilars thing forward-looking little potentially one indication, more about relates from competition I markets might think across XXX and like and additional to launches. look we’ve been what

out, be could on helpful. Thanks. dynamics really you play to So comment expect if you how would market that just

we Phase which that will. very those the Xb, Sure. studies, sure in have are on Well, so pivotal right we able right, educated we we And designs and think both execution, also, of be we’ll studies, high right I meaningful. to study that the we Anupam, are be now the in really can success think, of the are those endpoints from the focused going making have probability to program, a the show durability acceleration and clinical that that the pivotal

And the I dosing of us and whitespace one molecule, about each special interval, design think on to of think the these is I we’re lot I the really safety; underlying really what between think we’re say, generation and is to EYLEA. what’s efficacy shifting but mentioned of of like indications predicated And distribution distribution that EYLEA. that versus, data we is showing, the I X.X non-inferior a right, right, having profile, this it with to shifting think be which as and going substantially the that in

be to market, like complexity What’s we’ll, XXXX, the XXXX mentioned, really think do biosimilars So really out we the believe not all, that, first as be We for important we the that’s XXXX, as be coming branded strong will right? can of in and agents. incremental. very position, believe, If important the a we that timeframe? in differentiated we’ve of

So Lucentis biosimilars be will share. Lucentis’

And EYLEA to U.S. in share come exactly, some for eat degree. biosimilars, will likely the example, out whenever they EYLEA market,

to KSI would incentives in a physicians molecule, that a I lot plus high example. payers on support ASP this retina way of concentration. marketplace smarter, pharma, X%, are for maybe KSI, as We even there a the getting will believe branded of some We’re say, a drive is the that with like spec but I believe, sure, for

say, level of leading lot be price. have really excellence compete, biosimilars a take on biosimilars of retina to incentives things for, cautious in consistency. say, to and manufacturing are of see higher to don’t of we terms with And going to like players in course, a And, more Regeneron

So of those lot are a words.

target I like a be think this able really the there’s product share, profile to for key the even important if is Avastin’s us and possibility believe KSI molecule we eat bring differentiation. benefit that, we to with

then, KSI-XXX to more patients molecule attractively think go docs, vis-à-vis EYLEA, and make molecule with bring an who their an and be with we perhaps for And incentive will for a better priced retina money there Lucentis molecule. branded can our

indications all So this of we to kind kind the of doing pivotal we with such knowledge that and for the pre-commercial access now, designs, market, we’re continue these program we that investment branded of get when and that smarter, right this for think share. it in as study, compete we’re and through manner of to in terms in right thoughtful protocols think a we’re very and capability all Kodiak. decisions making But parallel going our can come fall we into we build of and

component years what all this I to of a well, going of And the hope manufacturing be a number. think we branded to key and market should capture we And percent from a plan we big X, in think standpoint, that’s is X. do of X,

And working from to be so, that. we’re the standpoint, to manufacturing able service

for question. much, you Thank Great. guys. Thanks taking the very

Thank you.

Yee from Our will next with Jefferies. come Michael question

it’s kind I on was for Thanks factor data. press given Two Victor. enrollment the in a to Hey, getting is commented thought Thanks, of this questions. the One guys. update. you pretty gating release. important And

What be timelines? you helpful. in about the Can are gives that you’ve timelines then, May, the confidence completion you and And what that in would just to And of these second confidence the That on for enrollment curve? those timing out. AMD? comment talk seeing laid question contingent in is this you of year about gives shape you what April

the I AMD potentially. data think we’re all for for in very excited XXXX,

or XXXX? till look back into all and about still that’s shifted Is is a the wait possible? off we that built analysis have whether it are the chance that’s Thanks potential hey, that table? much. any interim that’s that gone have this factors to just so and is chance that don’t at technically say, talk could something end of But the there the and Maybe there look things what on you that at given totally that

Michael. Thanks, thanks. Hey, Yeah. Right.

think wet February to I month March. in timeline, XX a AMD XX the enrolling we and were patients on

activated We have the XX close to sites States. United in

for right, and another a have say, total of, by Our large XX across globally, sites XXX objective is sites activated the to program.

expect March a the this let’s of through, And were, through enrollments say, say, patients April, XX-plus of increase month. certainly even We and end year. to end that we

sword not enrollment going the over this on in fall DAZZLE finalizing We’re to year.

is jam the those put we we percent a manner. and if studies we’ve safe I we think isn’t not thoughtful also we our could program, in States. potential, and what in in reason kind wet completely at – we and could that through actually to AMD It’s look – just done thoughtful with of I could believe what put enrollment rapidly you about of the pivotal ex-U.S., because be do want in enroll United DME we want patients the

a is want we we make these studies of ex-U.S. going have it do or to the that And we don’t in patients these have XX% want to from But determination, XX%, to site. that. be XX% to

And so, that we’re in to monitoring given complex Europe, slightly carefully. be dynamics going more fairly

little of bit patient ex-U.S. And last so, the studies in, in in bring a hold up the the longer to end, open component. terms may we

sort So for, into, that data be terms quick DAZZLE guess, see multiple as studies that a of early be that I means of succession. very with sort pivotal converging out top-line this data drive top-line XXXX. of of would don’t coming We that in And whole then, like that program say, could really would further negative.

our data of kind view at how of that an impact does interim analysis? So, looking okay,

in April, current that say, think March to to do and I able patients in were surprised the – – continue and continued that pleasantly to I think so. we our let’s wanted successfully with were we enroll physicians studies,

opening enrollment our shifting immediately, in Europe, patients I desire starting think. up and to randomizing up and with we little things and begin – And bit. almost enrolling a see recruiting, So

tumble look per were things XXX of up. were some think and April, I group, could things in very we’re sort to sort a XXX interesting. patients nasty take terms to begins revisit we to of the if enrolled, mean, interim, enrollments COVID-XX, right, in randomization be because went one-to-one at I they of of a than to that of then idea patients close even worse So of like and March so

to certainly what opening XX bit get number we we see rates, that exactly think north, should us overall, worse. monthly are I things at we’ll go of enrollment we for don’t it’s think, that I as ex-U.S., north But that don’t know We see we XX. up today to. where are getting today And a activate

data. and we people think be upward of well And that long we’re studies parallel things catalyst. reasonably a as think and need really concept the think want we And really I to we’re powerful So that very rather, like to will these have driving I the we don’t as focus a on. running in on continue trajectory, right, capitalized focused now, top-line financing towards interim as

a Look, what probability with terms the and right, receptivity, people and do our in is marketplace of the that do durability. Xb that’s efficacy of is right, success PTRS think studies? on What Vision, based of non-inferiority people of endpoints to these clinicians for people molecule about the And fundamentally hitting our the in of our of differentiated right, molecule how the molecule? do Phase think data, think

very the we a get unless the float a maybe is to in that’s want not because think, I if free you get hit PTRS, bus. lot we case, early by answer, a available. And that And high hopefully, there’s I think a shareholder, of as have

we’re that’s a very degree, of We’re well with funds pleased ownership concentrated with as to long-only tightly really large owners. lot and held early a as the

lucky. if going excited and be we’re want otherwise up early, So to if Kodiak you’re about later, because profile, pay to our you’re you excited

Thanks. I appreciate the perspective.

you. right, All thank

next Our Matthew Stanley. come Harrison will with from Morgan question

Thank it much. X POS? And Could could is be Xb you trial? Harrison. This on you. re-dosing thank Phase you for all Max comment trials? about it Skor Will the in the Hi, different the very in –regarding Matthew alter for any criteria way the Phase the

handle across Sure. studies? that want Jason, you portfolio to the of maybe

Thanks. Yeah, sure.

the call Xb the about thinking for is diseases. how the to us those criteria an performing DAZZLE. the medicine of what’s we purposes a DAZZLE, is tightened in different up help right, again, between Xb the different studies, study and So Phase understand Phase it exploratory little bit And the clinic these in

And, study active study right. is of of end pivotal the at course, day non-inferiority comparator, against the the a

criteria to in should DAZZLE say, – be in in DME, I Xb in and somebody whereas the DAZZLE, and if So are get the determining Phase when retreated in for – or are it’s criteria forward not basis, DAZZLE for a patient XX, or more right, whether XX XX right, they week regrouping, not in for going dosing get the on on the retreated.

a So also different. the purpose is criteria the little of bit

at Now, Phase the favorable, the Xb AMD presented to meeting time XX looks of regrouping like would criteria quite of that like actually, was those X patients on those XX that first everybody in the weeks. as the XX.X% being at XX.X% and with at of right, we said, criteria months at time at about Angiogenesis, – them XX% like XX if top criteria cohort in that DAZZLE the weeks, it weeks, wet you have right, of patients DAZZLE else met overlay, or

that’s was quite that So and – reassuring. exciting

the is as the between able disclosed DME the to look the to to criteria fixed So, similar KSI will fundamentally regimen design on I is we this right. months, the a and study, yet. X – idea But float where study case to we EYLEA then haven’t specific be think X in is DAZZLE, regimen

will the Again, have making that most the we little to a right same tighten, you balance for that those versus tighter, keep likely, Vision. right? comparison bit non-inferiority reason your sure meet in criteria need of you durability So

using. data So the that of – supportive regrouping we’ll and criteria we think be that the are very DME

six be RVO, could for every And then weeks and interval the of X the in the EYLEA’s which right, first one loading after monthly KSI months, doses. dosing the primary fixed couple the of endpoint, is, in

that is X not months. So criteria there in the really same first

you. Thank Right.

from Our next question John with come Goldman Sachs. McNeil will

guys, Suvannavejh. on I’m Hi, Graig in of actually dialing behalf

million that how think year? the course is? evolve over maybe from rate of burn How us. the quick one a And that Just monthly could sustainable do $X you

of the Yeah, I more well, like the if we what’s and mentioning more a think for was labs worse substantially to that Kodiak moved think and broader DAZZLE, COVID very in burn the stuff high like with attractive that, get rate. phase, into about don’t in have of were Xb like, sort rationale I where a kind like and is study things organic hibernation in efforts

hibernate for can studies a we existing running long So very time. our

we’re As we we going – its kind in right, pandemic seeing Vision, the have momentum, increase but as and with continue to ability – XXXX grow of accelerate mentioned. our we’re an the the to impact, plan, to and

we do then, service ramping those market, number level how September, studies are right, as as it for the of the There mentioned. substantially. as our of the grow and course, which summer, have a manufacturing background, over So and to in what of will BLA. right initiate as think right validation up the scale we think able be XXXX, many about, we at we I in want the so forms, of I and substantially, targeting mean the set we ramp millions we that well, burn rate the XXXX will pivotal, there work up, – the of efforts, new our gearing to And of – to initiation choices up then provide dosage do XXXX, related

about, is going existing, John million how say, to go. what far when our talks So $XXX

as appropriate, that background, think, really on slide. which aggressive into a think, BLA manufacturing fairly that the XXXX articulate XXXX. We enrollment, expect of and provide as definitively rate the one of drives think I said do of components. I How lot on we timelines guidance and costs. depends in enrollment, lot far I a we into related then I And the clinical

eventually KSI-XXX then I the begin pipeline broader to remit as costs we on retina this stage think, at our triplets. increased definitely the as company, in science a and part which will have our background are right high – is focusing of

scale the then activities for in and know, BLA. that of – to up the be validation the But and – of manufacturing pivotal our program rate driven as is KSI-XXX, by going component plus you proper our say, majority burn in the for patients X,XXX manufacturing

the in objective massive towards be to the of driven that going more Vision. of top moving will it’s sort rate, appropriate context on will but backward not all and burn that’s substantially, So And thing. looking like the burn increase of a of just by we’re be execution. sitting It’s of XXXX rate a

if And to downside? you about recruit enrollment maybe further think might sort you. all treatment enrollment I to know, data rates maybe experienced How I about you do patients, lot, get how looking and to how and uptake? talked at do you treatment patients going to potentially a even but one about if of did the initial surprise think only Would naïve Thank could think Okay. – related market of sort you of that, kind more. impact

Right.

the designs. into of to following treatment we situation into by think, comfortable We feel extrapolate pivotal anti-VEGF and being Phase Xb the – from the of naïve right, like patients. our able with predictability, going going the of framework I large really biologics

enough I get we patients enough and naïve feel very we comfortable that can we that treatment can very we patients. get think, AMD treatment feel DME naïve wet comfortable

believe, naïve We’re and agent, – to that, a participate those in branded community find I the such studies, biologic, treatment our as them into premier help to anyway think specialists anti-VEGF excited of we a we is studies. our retina patients bring

is not RVO in overall RVO, as, excited prevalence that For RVO, clinicians though, it’s our are less of the lower. agent just it’s about

So countries. going to CRVO? higher shifting new to a we more I to or we it, has plan design X RVO have think by as of go like we say overall the BRVO, study, upgrading But number efficiency. perhaps, predictability prevalence and so were And and think to were thinking, the than we is

think to there get naïve treatment patients. So the going with we’re we

it think in a unquote I we some context be patients. think, do generate treatment pivotal may a run, useful quote to data, using right, experienced

mean, not I is did hurt, little I standpoint, Jason, think think from commercial of if we have bit to may a that commentary. have we along had that would I don’t the line. some it you answer a provide that. want discussions

for to to in in months reimbursement going that, the the DME example, fundamentally taken to in but all some the our and beyond KSI were a that the and make because standpoint the label sense Having of have fuller we it to patients might think, right, to X because, say, we have retreatment could extent said That’s of in get can a we Having we’re allowing want that drop actually not can said broader requiring that, weeks. that that’s extent study they required use across medicine, terms need to so we’ve patients. that pivotal X patients label, from Xb. physicians want

be we it AMD, and the wet qX weeks wait make sense say, till not a in approval some way credibly believe where as data And broader and and label. could in treatment studies, after the to of minimum, BLA or after that the could those run generate do have doing to to to experienced weeks, have treatment qXX qX those get we patients to let’s experience, that some

your remember such week that can is way on And you DAZZLE, the that begin will re-randomizing pivotal, the go treatment generate. right, in X experienced that qX in people a sort may those to AMD And wet of population. we’re we EYLEA of one a in one, of defined KSI actually half patients to so

any it label, doing have kind that? a A need comment eye think market, a of are thoughtful Jason, that standpoint. on that and did our quick what a and in keeping good commercial a ways of from we’ll our on question. – and different I we’re we variety you or So

one another. there’s it I think you I I is a Victor, really data think guess, switch additionally would therapy when from say, that thing covered Yeah, on – like you I nicely. patient yeah, the to only what happens

of for continue study, for EYLEA, question. year an half them, people we of useful your better interpret, and also to getting a of switch why time with which part what That’s of data think on the the EYLEA launch, like We’re that a that when our but of take them we we the half happens where then done were of is right, hard at DAZZLE the a I those to to in patients, of them then kind themselves, lot switch and and least answer EYLEA. experimental be and studies way at those see, design realize naïve the treat rest

market or to patients, required. actually that’s data experienced for on market typically probably a that’s it’s I treatment critical access think, access, something because don’t have I not commercial think from even important, fundamentally perspective,

they patients, that, comfort a new a with new may already start retina patients switching I get when our until but trials. people may in physicians therapy, from than of they rather think patients with KSI-XXX lot using switch participating clinical start have were they comfortable,

to in that It’s – data and But ultimately, is questions. a timing important gives and clinical clinical to those it question answers do way always you to the a generated. – what’s can credible way of, point, Victor’s best will be

Okay. Thank you.

Thank you.

Robyn SunTrust. from question comes next Our with

on like questions, how of that X And that drug factored IL-X think help that? people that? Do and alone? thinking about [ph] is concerns Thanks having side to about that by community] Beovu, developing alleviating you’ve of as a hitting real kind trials way, it for even you in or a all if are time. IL-X this you the the Do But my go asking just I’m guys. call, in thinking Or am And on world, like maybe X are as thinking both my do I – taking well, I about like are this into needed? inflammation. of the to How in average see absorbing people an nervous you about trial biosimilars events. be versus maybe question. clear sounds a it – given fears what promise an you saying, was going I your you sense guess, some the in you. those really did concerns But much And drug, it the people in? [pivotal then I make plan? when appearance could I kind your I more talk when and your everyone do investment – patients? clinical Did as you think daughters trial – about have guarantee, about much setting clinical Hi, bispecific it’s that would could the in

a question. stupid probably is really third And

a So your Thank of AMD that BLA? in at indications possible? so it you apply sounds the Is like these all same you. and actually in all do it Would you time could RVO, X DME BLA.

Robyn. Hi,

environment I new around, well, because first is safety little of what’s happened new for question to is So there your bit a anti-VEGF, a Beovu. think

people I right, surprise, like is large commercial is, happened population, Beovu right. tail artery the accurate? think into some blindness beginning back, it when to see this did of an begin what a with report important And event, like I whether right, is consideration a that which the I occlusion, only there of molecule, think the right, okay, to of don’t or back you look really if inflammatory kind goes retinal really think, went right.

databases, FDA different look right, retinal of and some severe of can find artery XXXX of Alcon, back at occlusion. to couple events, adverse the you’ll a You under reports back under shortlist those

it So argue present et right, but percentage, always is at is you maybe to I right, it Novartis, the think quibble, a useful with seemingly – was could label cetera. yet, or in low X% X.X%, more closer

molecule? it is right? I think think suggests And manufacturing. that even and to the They haven’t don’t begin manufacturing Or you is then manufacturing, actual well, the with looked and I So given new cause. that correlation any announcement think – they’ve of some the at they found Novartis recently, say, it that’s right,

more at itself, I think, right. you begin molecule the to look

that biology for anti-VEGF look as for high non-natural high begin visual high ADA, platforms, assessment things of around very of Robyn, their all have this [camelids] regulators high these been discussed, you at sort to like right, [ph]. unusual and out treatment-emergent it, It treatment-emergent ADA, right, type of are And pre-existing patients – more of we’ve put unquote, seen ADA, biologics. right, the then as fragment diabodies turns antibody that other in ADA, European complexities lower some also that biology, has benefits right, very acuity quote pre-existing molecule, for the

biology it’s So complex right. don’t anybody maybe think or with to innate understands there’s Beovu date, immune whether be some a format. know, I that to really happens don’t here accidentally this I but

date clinical very across we haven’t years people and with antibody, at XXX billion terms have appear ADA, our to the that, Beovu. of a treatment-emergent pre-existing the seen spurious call have with now, any what to we fully or had current have, So of molecule. that haven’t similar low is, ADA obviously, And that see which problem we like patient what were measured in may we of signs don’t DAZZLE, any we’ve with KSI-XXX experience X north with

that enough an a will to people we’re do or and been assessments tail I I and do confidence event. rather think, some worry, really course, our easy that, right. indications you feel So more not program monthly of indication has across the have when right, there’s that is, in the data next. not generated? of well, And in series, Now, then forget question running than safety all all there’s pivotal mean, we we the parallel, then Don’t the the and with of pivotals. running right, next one answer

transparent, and much we efficacy presenting quickly of we can. be as we’re data durability as Xb study as and trying So to this safety, data both trying a running generate can this we’re possible, standpoint, as and to as as the from with

of good a and we there’s a baggage available, suffering think terms amount they this seeing think, special had. that we’re lot have any but pattern we’re of I complex don’t clinical of I biology. secret, the not So and same And design complexity data underlying fundamentally, of not in

So of a that’s comment Beovu. kind around

be we can manner, say terms the it’s protein, could evaluated you systemic our and it systemically. that protein would agent, the level give And of our you IL-X in right, whatever In COVID-XX VEGF, OGXXXX which of right, bioconjugate, be a dose acute component so patients, as want. call given

Roche per Regeneron, you terms the if from doses. molecule, you in at standpoint, think, mgs look different look quite a of systemic at or the you large But Actemra, they get have levels kg. can the dose I

a ligand. synergy across So mentioned, also And seen required. level very those as think, anti we think IL-X, whatever case we anti-VEGF, is we’ve also, get strong intriguingly as very I can this very both of some dose we interesting And biologies. in strong

molecule want be and molecule perhaps available. the so, And important, the make we so, could to

was First some real acceleration because benefits the same we the of of get for those and core ancillary at GMP the And the manufacturing program, really in antibody. Human time, manufacturing path of critical the IND

maybe So acceleration. into core feature talk strategy. a in of putting that’s a big of that of Jason, KSI-XXX BLA, you a then the indications little all about And X bit could terms single regulatory the

Yeah, of right. on need even multiple from more all that’s data, Victor, thanks, so think the a safety that the United it’s better at – I that time, reasonable The at information have, medicine your the the the States, have perspective, Yeah, more course, Robyn. I sure. agency’s to – Thanks, and least yeah, approach data in and that if indications. quite – the think, across a you submit you right the safety particularly you

of the as the understand safety total it well across I So idea the indications. think database in can efficacy where the as they package submitting one really different

nice quite strategy. I think that’s a

those and to I beyond I us Jason, to basically together. would they in AMD that, even that mean, there say writing FDA the I wet DME, I like have mean, we from submit mean, receiving, the – expect forward would certainly we look

together they decisions, to think appreciate, quality them X all higher – I guess. them something it is of submitting I they So because make that allows

Well, And you. thanks color. thank the for

Robyn. Thanks,

All right. you. Thank

comes Our with from Gena next Wang Barclays. question

Thank taking I my you questions. have for questions. X

one follow I single understand FDA. BLA talked The the filing, also first you that with

Just trials wondering, agreed trial, FDA. was that with with feedback? and RVO X that what X upon DME EMA AMD the wet X And trial is

on CRVO? X% visits. will with and is RVO than My – BRVO between third the regarding And the question the what patient less be study, question second done and your X% they’ve thoughts my regarding missed the

the would impact clinical data? that And endpoint data you data analyze the how collect afterwards? you Just wondering how how and the do do

Right.

I from what FDA kind in our we KSI-XXX right. what them? Okay, think have want just specifically, upgraded Jason, terms questions, of maybe hit to first you call of to we and pivotal the the the is summarize well, plan,

the So where within terms pivotal BRVO material to important second the on important Yeah. and this for them are basically single and study, we the they the to to FDA we study? being is is happen; what it that? integrity or missed we breakdown of in expected have of and CRVO. And are the do that third, prevent doing when The how RVO visits, if

Right. Yeah.

are, So the maybe feedback, FDA X.X more I more have think, with branch is of stratify we like well subsequent sure comfortable vein terms a of we’re where feedback on think context the different the that the are. RVO, in as regulatory sort I is regards vein if single branch written the common, the I to central Yeah, the the in study, represented. common the as X of cap, with on subtypes of of question, randomization Gena. quite in of we and central conversations. The to make you sort to would between community, vein. probably RVO vein we minimum number will the you what’s probably, CRVO vein times in it’s is mean, adequately that so this X.X And, category where that a of like depending patients than patients branch

patients sure the study. the represented on in So they’re XX%-ish a central probably vein make well that to make like sense minimum

I missing and And handled they also also study. time those high like data In how visit, series many that’s at visits I’d think powered methods level, terms just say, Then, in for data routinely there’s discontinuation that missed opposed rate of is of row mean, adequately as as every the patient I a missed always data? are, say, or missing or to low. are does in in a the that and study visits provided as a missed is a statistical a missed the over scattershot our study, assuming really by certain opposed visits, I of data from of the mean, to one impact for right? a discontinuation the very row. rate

a methods imputing mean, will most different missing So, have basically different the modern of – data for – study. statistical I there’s methods in

continue should considerations that across data, a those But a should distributed So rate also fundamentally those with particular where certain will whether fundamentally it’s they really do then multiple equally are, number of a the any think, they’re impact protocol that the How and question specifies, patient visits. But of, meaningful really I should if distributed, visits missed be bias. think absorb without and in they’ve for an be to like, handle groups. a I patient of study row. miss, the a they visits you at important both source missed if

Right.

even DAZZLE pivotals. the designs as pivotal the look new educating right the detail, I right and design when think in we finalize, think more at we margin ourselves about for we the as on of the

still the can get XX% that, believe visit is us or number higher I to rate. or more we think, studies than missed would give, outcomes. good we withstand substantially and whatever, don’t right what have that we know a it very but would I

Okay. Very helpful.

regarding Just is the [bureau program the file] that? [ph] what the design, wanted EMA follow-up, or to study feedback pivotal on

Right. question. Well, good that’s a Jason?

Yeah, advice. versus EMA indications sort to have in of some be ultimately I’d say, terms at depends once? it file national you can I scientific them, they – were opinions with many like more EMA, of on think how conversations somewhere

indications We’ll that versus with ultimately. can the some So of like subsequent I how variation. those license these are discussion EMA more think topics you many initial get in need

back retina, Right. one Kingdom, Gena, whereas the anti-VEGF physicians, response gone there months. in treatment has it’s of as well, new the basically to basically think, in It’s of course, or But still patient. the feedback have in from States, new context in patients, for visits the although I United where COVID-XX Jason the mentioned, thing Jason at, best come guidance proportion I say, are mean, think of right, patients. see And down, in specifically what’s wasn’t United treatment data, for naïve right, the has visits looking X that’s from the the – been – the basically is interesting, been injections not to increased. has the guidance the UK, seeing I been naïve

alignment important So product KSI-XXX of differentiation Europe. or the the for of there’s target profile an

leave right not medicine this nice in studies these because diseases things one fit, for the course, patients is, our do opportunities in pivotal maybe running just for for be our And to but profile to without we’re where like therapy. unique the for I to think Europe, going a months – look to I X of with of example, mean, UK, reasonable is new it’s also

you. Thank

you. Thank

Markets. Our from Luchini with will Capital next come question Matthew BMO

question. afternoon, Hi, for and the good thanks taking

RVO a COVID that first So that to other are beyond timeframe could I from from trials start any forward? of me, revised putting environment, sort the the couple you’re those with the impact factors DME, regard September/October guess, there study new timeline, of broader the

BRVO it, CRVO. RVO in a or then, wanted the secondly, to it either the explicit. single And indication-specific a last still just as touched I broad is to but plan I study, just to something make to question, think you opposed label get RVO With on

just lastly, manufacturing. back wanted to I come to then, And

if to out. so, could couple you read XX today, and a and the versus need times. Thank as think you where bit just be are say, hope remind revised pivotal And let’s about up And are you. these come you next, it’s a program, XX months of to starting then, you us what little over for where studies to you the ultimately,

on today in have September/October and information first based think, comfortable about that human I we’re independent we’re think very program. the I mean, I Right. a decisions feeling mentioned the and the for COVID-XX, that as of new I making, mean, you I we think,

for nice, And right, to able targeting. we’ve United that we’re States it’s framework we’re to example, the what going follow really same be put that’s DAZZLE the say, in, sites. into So because in the

of these as for the pieces Jason mentioned, design has a to the DAZZLE of study lot DME similar very a the And example, study. studies,

then, these directly sites. paired going site And terms into DAZZLE to the site well. DME then of activation, we’re And Europe, the directly and as to we’re same DAZZLE these into of pieces flow RVO other lot from of studies sites. studies new come is for going the right, ahead into a going So we’re the drop same in in same to

there go many So Europe, in – there. countries we ready is have basically to approved and CTAs in we’re

didn’t these right, in are we good. well, the happening want feel – of, based So we but terms we should studies that conservatism, do wise, on seem those to additional targeting quite of transom activating September all what’s And there. really good with COVID. just seems in June, And cross

the In we’ll mentioned, coverage BRVO And terms of RVO, in both believe Jason we have we’re pivotal. for in and CRVO good that, believe as we there. shape

when lot material, don’t market, from you manufacturing, not there’s be going good the obviously shape. the discussions, of have a hit clinical If retention the to you’re I types of in of on think these standpoint manufactured right? on you your

exciting in years wait We pivotal service of market. don’t really generating many a really of want then and to the be you before to all we’re situation asking data, able to

spending we’re time. good amount a So of

a think the attention we’ve the and had I date, is that for that a number a and wonderful put have of safety into such years. we fact testament to to profile manufacturing quality

able down. and If the right, when that into entered it their as and as now inflammation, up to from you were then XX% had liquid market, clean Lucentis, with their prefilled lyophilized much brought and syringe, their remember, they that to it into formulation, really

and trying to want We’re launch a in syringe. prefilled

And so, possibility. make a to we’re that working hard

currently X,XXX XX,XXX We’re scale, that we’re the liter into to for launch. we’re shifting liter X,XXX [Joe] at and range [ph] – at

our to And fundamentally, cell the make be we work development same will to process, it’s to is commercially. be similar some overall ADC-type as conjugation bank master that’s that and there scale and where very uses we tech-transfer conjugation the but methods process we do want in the So methods. bioconjugate, industry-standard

say, technical into, up challenges any larger there, it’s more rather don’t technical, again, core we so, anticipate And scale facilities.

great work That’s lot there. of a there’s question. So a

X, of you million well, doses? example, XX of in post-launch millions say, it What that is investing? X, year, years part of injections and X terms market ask do Kodiak market the of in that were I were, think percent last intravitreal given globally. be there we what think can of think, community, the branded branded percent you should and I For

it’s up. drive And X% to credibly X if helps XX% year, scale that And were at that’s right, to that million, right, Avastin, X growing and of what half of can say, year view of market well, a manufacturing X, percent our So, let’s KSI-XXX in XX.X grab? and say those right?

prefilled it an context as quite it’s So interesting we’re conversation. the of syringe well. to do trying And in

that and more maybe important So activities couple of over will a years. the of become lot next

bioconjugate amount of of substance manufacture did drug have successful a XX we We very we that last a tremendous over the resupply months. and

So pivotal bioconjugate the of program. we’re very service drug good in supply terms to

towards is attention BLA and towards our the up the really validation the scale activities. So

Great. Thank you for color. the all

Thank you.

with come Roth Jallah Our will Zegbeth from next Capital. question

on terms in investors that of from just next what What study. for any of hoping longer-term the are you up pivotal? your that, hoping I come question data focus with then, the that elaborate set in to of quick follow-up are apply program KSI-XXX? how then, learnings and data another idea diseases? you to or question any did expectations that Phase a data? just out see that the OGXXXX regards And curiosity for the could here, in you just synergism to And can COVID-related with amended you have would the you between Xb on And that of from

you Could repeat first the again? question

amended wondering for longer-term in of Xb just Phase the data? so Yeah, expectations terms the study,

of think well, core is year of this right, the what on our durability, kind we focus I durability call right. All the

early was across And X out sort to of retreatment was the through So that a of coming that diseases. loading loading then Phase now, and who time that and phase, of phase, the bit patients? how the got looks the it first of Xb we’re X And the of retreated or kind population of X, retreated at, X that at they months, looking across the do at people, get durability X thing. when durability, say, months sort

exploring. be So we we that’s now, really that’s interesting where should think a focus. right And

we you And to, the out as say, doing X of nice all, course, realize, that? of see it’s to a follow why think the study, individual we and extending first Well, really way We’re, years. are want it the of course, that And patients to extend and safety detail, safety to a little the helps medicine time. and of kind patient have experience. like of the also, of database over we bit that

population the the very a trying in of encourage following how generated. data of we of through in And publishing study maximize to then the as course, the the hopefully, a to quite and X-year providing and the anti-VEGF rationale background. really be them this stay to period more that the lot in that’s and terms to on of and track of carefully. biologics So medicine patients that many we’re in learning And, transparency work utility

Thank you.

of with longer comfort treat I think that’s these patients term. I safety physicians’ really level helpful, of want continue to to even in to the suppose terms

syndrome of I’d like bispecific COVID-XX bit little the And to ancillary of program. the like KSI-XXX the some OGXXXX, and anti-VEGF; is these protein, I in of then, release context for maybe mentioned, like of this certainly, the the of kind the right, of a lot the benefits two synergy activity in yeah. anti-IL-X overall the mechanisms say, a Yeah, cytokine there’s of terms surprising, component. But anti-IL-X,

you in I Regeneron what of permeability, cytokine more think virus by actions maybe get the pathology the vascular these But data permeability you recent of related vascular of ideas mechanisms that’s I other kind get tissues or like of directly we that to the edema. in is this some and is tissues the either from are right? parallel, maybe that’s like that release, that, there caused in the happening see think the some or And

anti-permeability Well, don’t the in an of functions that works forget agent, how on It’s not really really vascular right? an agent in It���s it and it anti-angiogenic maybe terms eye, anti-VEGF. permeability.

with this can quite in anti So if that’s synergy. important get the piece this showing you permeability kind of that’s that’s anti-IL-X And disease, potent. molecule piece a in

ophthalmology. course, which run is look continue going core antibody, and that on retina mission of basket while of drug in it to to make as these of And our we’re how release our a available do so a clinical some product we, substance, studies anyway. in we and And drug manufacture try

Victor. Thanks,

Sure.

for at right, All over All the speakers, questions queue. in [Operator no like remarks. to right, thank there further Instructions] are it and turn I’d closing time you. back this

Well, year. Thanks the up-to-date activities very this Bye. thanks, everybody, the view for participating. And, of hopefully, for remainder it and much. gives a Kodiak of you so

ladies gentlemen. teleconference. you, today’s concludes and Thank This

Thank your of the You enjoy your may for please and day. rest you participation now disconnect.