Opus Genetics (IRD) 5 Dec 232023 Q3 Earnings call transcript

Greetings. Welcome to Occupier Pharma, Inc. Corporate Update Call with CEO, Dr. George Magrath. [Operator Instructions] Please note, this conference is being recorded. the to turn LifeSci Wood now Advisors. will conference Michael over of I you. Thank

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company SEC, this including in events, about the strategies and financial potential or During We encourage or future you to identify company's commercialization regarding may the that milestones, and statements the materially events from conference clinical results beyond. remainder milestone course review forward-looking filings statements of of those the website, the anticipated past the cause with future described and which will differ actual business, factors specific in and make XXXX future and call the payments plans statements. forward-looking to

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Fitzgerald. [Operator Our Cantor with Kluska is Kristen Instructions] from question first

Dr. Magrath congrats appointment. your on

Looking with now. working to you closely more forward

in interesting some are a It's that, not in So I of a And if seeing away. around the space seen the question we're first had they're lot ophthalmology APXXXXX. the case. situations, not reluctant AMD, benefit right was where, a some more to seeing in because instances, necessarily particular we've lot injections get that's examples patients dry

could you about oral and see taking burden I patients an to research for taking wanted So the and there these is your talk how not market the openness bit much that injection robust. particularly little more factor the therapy, remains a safety assuming therapies to also profile if

out, pointed as that correctly advanced nonproliferative diabetic is Lucentis right, you as or intravitreal the that Eylea people And X retinopathy, or used, may be injections. others there with

has this. an it, have for However, like they I they to think will is patients that because these So -- and great like don't dry you the disease atrophy. uptake right, gave treated, are a go life, of doctor high dramatic get much it you where see at baseline reason stroke. and back the immediate think of right? seen for where in well until effects or or we've are and pressure. that diabetic what waiting in it in in impact stage wet have what be been macular that of the It AMD their edema. geographic in geographic patients good AMD have of -- not until atrophy an particular, you of is do analogy don't patients to typically do these blood you because is until tolerated treating of uptake get because attack that's And in I side in better These People a They heart the than oral asymptomatic. about in know older. one goes sort the We

areas have blurred their So do vision they where is out.

vision are that started they vision, honestly Those lose the -- They that started and area understand blurred. already terrified, in gradually progressive until so want the bigger loss. are to side have have entire pretty don't they disease, And so area. They that it's the And continue, these happens they spot because patients of patients blur little in right? they have effects to get of is center and a vision, what to right? it spots of get the

And are around diabetic told have Those patients don't really they're realize don't disease so vision. with typically In very see They they haven't. actually something. they walking you good retinopathy, they anything. see the until

someone are Now do and is or for you for the don't a like for line. way for reason for geographic is the issue that here why let atrophy or needle an the an because a X oral AMD is injection wet they they to eye not when -- DME convince you or appropriate in the intravitreal poke bigger rest asymptomatic, months to every it their of to X PDR

said, like someone working-age So to eyes. XX like years it's big families, needle doctor months they in X XX, for typically Typically, the ask really booked of every eye a stage is are get to have people jobs, XX, have They life. they're their assay the to a I go X these and old.

acceptable of very typically, are this for therapies diabetes. they the complications every multiple on other pill is patient And a day potential so for And taking population.

market dry an well, by and well is people that an -- And as AREDS, questions. tablet patients. correct intermediate put this. is for these has and of of And vitamins, are asymptomatic given that look right? in have tolerated should The patients are nobody for oral our it the to the and so to universally get these received that's indication I AREDS care who all Number you uptake of at is patients are patients is AREDS would the on AMD who this it These the vitamins AMD. this oral.One, is things dry used this standard used one couple intermediate point showing -- is a community well for And right? for it's with be it research

oral -- I in community. treat something with the something for to And be have it's accepted generally that we an is that else, can't patient it so it's retinopathy, or we're can future, imagine by to going the similar going diabetic APX whether where

meeting, can But first of -- available, tell they the is from can the and number and the community we summit their a thing Diego, had I the at there you I'd -- reasons meeting were it's oral Ophthalmology companies excitement therapies past they in that in their you San particular, ophthalmology of through held And presented. a second see website. this ophthalmology point you indications therapies weekend to was are different the oral in lot it Innovation and The DR on we about section exactly and other for OIS for mentioned. in that Source

question. I good that So really It's answers question. a hope your

in million how patient opportunity look Wondering therapy you that X then profile that? of there's thinking segment, advanced expansion likely be an with about and think the to this commercial initially is might on disease. comments mentioned think you that the And most you patients if initial after

Yes. It's a good question.

happening So this recommended is part diabetics that, part the all exam, are too. and all It's and -- CMS health should initiatives HHS the of care to the their to it's envisioning care be that yearly and diabetics, quality way primary I'm it's like stuff for kidneys the just a and of like right? check you get --

getting are exams. patients these So eye

-- pretty NPDR. eye diagnose that moderate, And at to mild, so I straightforward severe exam an think it's

will envision And become these to we they are NPDR, preventatively severe or I mild-moderate there. I have think patients patient going be out has of when a that are care products sort standard good of once so that And identified. treated the it that

over important do think I are is truly therapy treating the But be it really, after. above. we're doctors, significant. in by or that the and the care optometrists, will think do is that unocrinologists about in aspects somewhere the an the benefit other I is injection be commercial is help that we advantage all I think might air, that And for uptake a systemic We going diseases the really a body that And would or diabetic it's But that tolerability having for don't the mediated So profile ophthalmologists, I that the an thing time? at know the elsewhere the about one primary the stress it you program. possible to think And know yet, an there So eyes, over is potential safety the in not oral up uptake market of well? of an super it But the our that's with prescribed I important. or topical. the the oral as that that's be indication whether of and intravitreal right? don't same will this that

has ours far, been so And favorable.

I NEYLEA APX Ref-X a favorable the safety reduces does or think aren't back you with would VEGF level. VEGF is that you decimating that's tolerability the [ why the Sentis systemic in We're them part part profile we reason and because an think because, Avastin to completely others deplete ] we reducing levels. physiologic why get favorable that's that, doesn't or as of with And others. levels to like modulation It I have reason of is levels. do know, guys the actually actually them the a completely that's the physiologic

and favorable of real for a So modulation patients. angiogenesis mechanism APX the that's there's quite quite advantage to elegant

GLP-X If obesity just squeeze lot of diabetes. I We've there's around in and one obviously a the and excitement could space, question. been last seen in

are engaged to diabetes at as this space, expertise you to or time. that becoming open wondering, a that you you're think have in both I'm more more with partner route and perhaps or in appropriate if pursue these conversations do ophthalmology it's pharma speaking So companies has target that you potentially with

that right? right that's hitting we metabolic treating key And very are think manifestation. and you're diabetes are I a disease, on evaluating now. insightful, Because we thoroughly a incredibly point is system [indiscernible] strategic

are We there also of are treating the ramifications in Ref-X eye, but systemic body. the

at And the So We so answer. that's don't closely know that think yet, we looking now. are I very right? right

having hopefully, the treatment. and in you So appropriateness a discussions, to those on able guys discussions. as We're those our we're we'll in future guide be metabolic

are time in happening -- So very and for right a metabolic it's now a patients. exciting disease great that's things

very it's we're So closely. something evaluating

John is next Our Canaccord from Newman Genuity. with

then be I'm design the at to you couple, weeks in be I you in Phase able a in know III example, the that expect at about X-step did the finalize aspects study of just had a in endpoint and also is, And study addition mainly I'm design clarify debated I'm path at are some II? basis to I for APXXXXX. looking is the around curious, on or the key forward the potential still for curious you look for What you monocular worsening same planned, would XX being SPA? the Phase but that just looking as wondering, what binocular. you're will to that would

answer question. great let second the the Ron John, first it's part, I'll part. and I'll take a then

SPA So are in talk I'll of scales the that Phase of the working let the then and aspects the through. -- part around the for itself meeting. proposing Ron has with the been some Phase I'll we're we that, endpoint how agreed II and about answer the that and that and FDA III And

my the -- aspect that endpoints the for for mentioned. So you of

at we be will endpoint. So a XX-week looking

hear And who there talk worsening. looking panelists appropriate And was will quite in a size truly move patients to looking that be for upon the because we've to is the we're rates FDA, event what and disease with at trial thing right? agreed Summit the are is So appropriate very at how is to be about a mentioned it retinopathy do an the I this point, these at very, a diabetic X-year endpoint, OIS diabetic evolving endpoints eye the really in interesting at because which and interesting. there clinical are towards this going weekend,

which And X-step we're to coming approach you prior in it trying -- the the gives with X-step at exactly to Phase right, PDR is other the whether portion at trends still become advanced So prevent vision they're that arm. yet. the came you in whether disease, [indiscernible] to improving APX and at the going about were if logical haven't loss. looking in then prevent of And not have at they some the angle, you than is that worsening, we intravitreal from studies loss Then in were DRSS. is if to X% looking steps. or worsening going looked an at We're that of like done step vision from And monocular where was that they actually, then them look right? binocular X at but their from what about were what that, moving worsening we not and the PDR arm, very have that. care II So event lower they're of were which data disease trending the X-step at on looking we X-step on they're to progression then the having We were gotten at saw in the when towards the improvement APX injections, trending a rates do level lower, less being asymptomatic in a you worsening APX in improve have, what patients they not we you or XX% being the the when arm. are lower arm looking the APX you

am So right, that care of walk really logical towards to the is makes lose which vision. it kind real going about, a patients I something

are of that that's I FDA it clinically a endpoint which vision because loss. done very a on endpoint great objective the Phase the It's meaningful because patients at it's for So the II is identify risk that is at end photographs. does towards advantageous is meeting. it endpoint, the And think -- truly

ophthalmology manner. in look retinopathy So diabetic really general, this step is a to for great this in at forward

thing. And think wonderful I is so this a

way, can And You in those lot it to on is which sense monocular of treating both we're about to was a more answer monocular. question, at last systemically, you're the but focus in when part makes eyes. your a look that's what it going But at look to eyes.

a powered for II for think Phase study is for or I so we do -- to wasn't the or X-step what worsening And vision need PDR loss.

replicate the SPA also Phase little if power story but in very, for bit. it III, we that, it FDA, just for you those, not a Ronil, So talk can about think for patients. when we a have I over to to meaningful the very the I'll turn we

Yes. Sure. Thanks, John.

X-step I just had pivotal already binocular a which worsening on on our the agreed remind So want to DRSS III primary we that scale. Phase for the trial, is endpoint

particular, will need X efficacy placebo-controlled a The X-year with in the solidify the on III the pivotal Phase statistical protocol standard and exact FDA collaborating the to is plan. endpoint. with trials the language on the broadest of aspects secondary analysis of the with how the statistical of statistical handle having SPA We possible. to label ultimate exact certain best number and hierarchy We're analysis really plan, in patients the the agree endpoints, powering, of the goal the

purpose job. of the the that's really SPA So

time. I management conference the are closing at would back turn over further no to like questions to for this There Instructions] comments. [Operator

for to we more future like guys pretty development through here. would and to us being in the rapidly everybody thank we as provide program I look progress and the interacting with forward joining you to So today, able updates

conclude will This today's you. Thank conference.

You time, for this thank your you at and lines your participation. may disconnect