CLSD - Earnings call transcript Q2 2022 | Clearside Biomedical, Inc.

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Operator

Good day, and thank you for standing by. Welcome to the Clearside Biomedical Q2 2022 Financial Results and Corporate Update Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jenny Kobin, Clearside Investor Relations. Please go ahead.

Jenny Kobin

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

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

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

statements will like disclaim Chief Thomas the questions. even over While views George these elect future, call, we Dr. Chief forward-looking update Lasezkay, so do the to have our and specifically Chief Development we Executive to we if Chief On obligation Financial today's for Officer; call our Officer; to to now Officer. turn After Medical in the I formal George. we remarks, Charlie Ciulla, would Deignan, change. your our may and our Officer our open call any

George Lasezkay

Thank you, Jenny.

multiple fronts. Over the on we've last progress months, significant X made

created SCS drug new XIPERE, retinal the with paradigm approval of CLS-AX we've broader of With of a delivery. Microinjector the and use select partners, advancement our in

SCS I/IIa by both inhibition X the the the we OASIS trial. axitinib, targeted announced is enrollment in now X single completing of escalation In we significant And a positive Safety combines Cohort highly X with reviewed recently potent that proprietary milestone enrollment X tissues, as the a to Monitoring accelerate OASIS, a we Microinjector. to we the pan-VEGF we Cohorts May, successfully in safety and from were the On side, for result CLS-AX total a clinical patients delivery data chorioretinal our our Phase CLS-AX Committee. announced able trial. operations utilizing have dose all initiation dosing TKI, cohorts. affected XX of with clinical achieved of by completed

as We CLS-AX, Coultas into report us this ophthalmic Officer, Tom, injected expect of year. strategy, final as including safety our Clinical all operational from suprachoroidally. X we overall will continues OASIS' this set June pipeline clinical for have extensive our the tolerability clinical advancing product assist cohorts that appointment planned trials Chief of and benefits in and trial comprehensive to clinical Susan Chief believe data early for potential Chief for clinical experience stages announced Susan CLS-AX our November the through more from To joins X-month responsibility to activities the and insight management Officer data responsibility We design. Clearside provide all Development approval. Officer. in and further Medical with development of

from successful completed for + to first recent of this XIPERE The partner, This financial commercial because our product oversight board launch sale provide supportive. support to Bausch entered If approval trial. begin we announced enable I of our this and soon flexibility to the Microinjector execution us on future thereafter. be clinical a our the data call and agreements responsibility discuss the OASIS now will Tom? to Royalty SCS U.S. have in to assume from will of by the initiate operational advancing transaction Charlie our of interest II into commercial financing meaningful it will achievable the patients planned environment. funds us excited are our CLS-AX We transaction Susan purchase of royalty this end by final planning made our study we Phase on the OASIS primarily should of us by We product, the Lomb. provides Phase with that financing funding to of future to our and leveraging Ciulla will subsequent readout CLS-AX management turn this Yesterday, enrolling XIPERE, trial trials. now details and Tom and now Dr. Partners the market partners. is, shortly. FDA certain license position HealthCare for the clinical over of the agreement during to by year was activities obtain and assist non-diluted to opportunity elaborate volatile us the because II capital clinical royalties progress

Tom Ciulla

Thank as you, made morning, lead good everyone. George, discuss Starting in program, the we completed X CLS-AX, months we our thrilled to progress last the OASIS. I'm and with over tremendous enrollment

milestone we trial, patients our with dose enrollment dose enrollment is With to the of completed to X in possible. extremely each dose the total XX awareness grateful interest than X.X complete The received X Last milligrams. patients increased whose and a suprachoroidal starting in a and and Cohort X with OASIS to in X.XX this were the milligrams patients. greater This of OASIS dose completion and month, of growing we doubling arm. critical a team I'm and time commitment of OASIS is of of company. dosing Cohort the to received for in of XX-fold X able a X our Cohorts that patients investors patients delivery Cohort investigators, of final milligram. made our -- X X

inclusion. reported patient for is tolerated Cohorts dose-limiting Cohort Committee OASIS as from safety Safety first-in-human as in date The high and we by the X has reviewed well that data set with have have CLS-AX safety been toxicities. our X-month In the demonstrated a study. initial we well data X to X all no reminder, a OASIS, Monitoring As standard

presenting treatment-experienced extension forward study in only ongoing of an We patients is active to follow from X all as II this OASIS. for X, by selection from center. and X additional X data safety and well allowed completion months our the to dosing criteria Cohort appropriate to enrollment analysis November, confirmed dosing trial. both patient after will as the facilitate X look There patients independent most Cohorts cohorts as X for also as Phase of disease up and X the in tolerability complete reading our with Our protocol an individual

end later to year. plan suprachoroidal forward minutes talk on progressed II has Cohort present from NAV completed AU-XXX, our choroidal I The the for this investigating edema they an stated evaluating VEGF. advance take development clinical Annual in accomplished gene of Phase III is of tremendous diabetic on Retina has programs Our trial right AU-XXX Aura REGENXBIO a Arctic and with at International further that gene to conducting delivery Specialists, Microinjector. look updates with suprachoroidal to as decision wet Phase the RGX-XXX, delivered investigational our trial macular the month, II Vision, I are has deliver American was RGX-XXX administration They enrollment also with Meeting Last we trials treatment Ocular that has trial a via additional the macular it Clearside has of melanoma. also before a therapy on plans utilizes the Oncology onetime treatment humbling our drug impact finalize to of diabetic that In currently a their running and clinical to of fragment SCS on in delivery virus-like initiate partner treatment programs vector XIPERE encoding want approach. a inhibit to June, therapeutic data patients community. enrollment edema. X X programs associated the patients our AAVIATE AAVIATE program Phase partners. the completed X in has for with uveitis conjugate the We partner suprachoroidal a ALTITUDE Asia have realize proprietary for delivered trial pivotal currently of in the commercialization the at REGENXBIO well. Biosciences the to the commercialization year. presentation and continue a their Phase of the REGENXBIO's to Aura made of AMD for retina REGENXBIO for trial quite few retinopathy. the about all Society and antibody our Society novel via Microinjector to ongoing. SCS

drugs uveitis. to well drug other commercial With partner, space absolutely The interest elegantly product space an insurers their recently suprachoroidal presence, which as Our in trials, associated to way expands has macular payers. + use as patients the At the the a delighted deliver our the drives and versatility and its towards This SCS and posteriorly lower space. see received This with commercial featuring is occurs the strong valuable of the to Lomb, space therapeutics help the posterior Microinjector our agents gradient circumferentially on around Code. of of team was into of to Microinjector on into clinical to this launch delivery the X growing treat extraordinary. as Microinjector suprachoroidal milestone insights deliver Bausch reimbursement physicians this into drugs macular potentially for injectate us edema in provided billing to U.S. suprachoroidal a with their suprachoroidal physicians for as XIPERE, J conversation as natural proprietary disorders an important the space a its clinical I permanent pressure simple code allows as pressure recognize SCS novel SCS was treat office peripheral X use ASRS, to suprachoroidal MAC. commercial and space.

To were expanding versatility our of a X There and Delivery of highlights a Annual cover XXXX delivery. ASRS, World to in well-known to injector, summary of potential in of comprehensive a journals well retinal SCS is SCS we Innovation special the of addition that and suprachoroidal partner. Chinese in This our edition I'll In Academy financial X Arctic flow will Vision delivery that, in Asia-Pacific Retina community, results. Technology. to the Asia-Pacific the the suprachoroidal of Ophthalmology the Summit With gene awareness peer-reviewed Drug Society. in the the Asia Congress, biomechanics now published delivery treat ocular MEDLINE-indexed Retinal We're Arctic support quarter review attributes presence have link our outreach the the Vision, uveitic oncology. therapy of to press our Congress the last mechanics publication the to Also, over the and strong XIPERE Meetings. with also leading ARVO the that publication ASCRS released suprachoroidal the pleased website potential are turn OIS delivery, on articles and in the meeting triple of journal, the entitled There's Society also physician at the from today. injectate, at Charlie Vitreo-Retina Ophthalmology presentations education to papers approval of Charlie? as XIPERE uses at support system. as and in trials support our had of a care macular we to clinical edema Deignan, release CFO, to published Suprachoroidal Physician, call the Ophthalmological

Charles Deignan

Thank you, Tom.

for press results in release financial Therefore, our available and published are transaction second financial I our morning the Our quarter current website. recent were financial this status. will our and summarize on

follows. The of yesterday, Clearside. million, we As breakdown up non-dilutive a into Royalty $XX receive all may agreement Partners. as agreement to total, we George which of funding we entered the terms is with royalty announced mentioned, that to HealthCare financing In

+ XIPERE. upon partnerships Royalty second this be a SCS from HealthCare $XX current We milestone Biosciences. prespecified deposited receive milestone March payments and payments upon will certain will by will with our license agreements. to escrow XXXX. payment also less XIPERE for upfront of $XX.X sales month In for additional an prespecified milestone to due this cash Arctic to agreement for Lomb, royalties REGENXBIO account milestone Bausch Vision, Aura Clearside expenses. to of XX, payment of certain month the an us Microinjector million attainment attainment us $XX.X includes of XIPERE released from receive The in also million of sales additional terms provides an An XXXX be from exchange, and a million, This

the in confidentiality of programs, or met Importantly, payments in-licensed If this including arrangement total and considered by publicly not HealthCare certain capped sales our at to XXXX, to made agreements well assets X.X HealthCare specifically as excludes Royalty. be milestones parameters end thresholds by X.Xx partners, future with Royalty by agreement. this will with existing the we all cap of increased are will amount disclosing Royalty. as not any is our HealthCare the of The CLS-AX repayment other Due payments assets. total the made internally developed be

June XX, and cash cash $XX million. of as XXXX, totaled equivalents Our

us million our upfront runway of into payment existing will Phase runway from clinical that II royalty fine-tune we the million XXXX. the for we of CLS-AX, plus $XX plans combination $XX.X our We determine guidance. trial our expect be to with provides transaction the able Once

scheduled We have month. conference this an active investment

We BTIG Ophthalmology on participating Later Conference Wedbush call this will also his remarks. turn and Biotechnology look now in be back participating the the We Day. Conference in George the closing H.C. will PacGrow tomorrow. you to to interactions these Healthcare be today later keeping I'll for the Wainwright over month, we forward updated and our progress. at

George Lasezkay

Charlie. Thanks,

our SCS proprietary momentum, Microinjector. significant building are We leveraging our space technology, platform suprachoroidal featuring

focused and team, our the CLS-AX anticipated we a we clinical programs resources, improve were catalysts and trial financial multiple both to from have management our result, clinical able to internal As related our expand commercialization and it sense development with retinal in our with makes own partnering pipeline strategic partners. our both and Clearside. other We strong internal diseases, on companies developing for interest remain where

OASIS to I in investigators especially to and remarks, As November. our announcing open participated We like trial. to forward who operator OASIS conclude the call my our in our like would up Tom I'd the questions. for the final said express and look reiterate staff, appreciation what I our to ask to to our now patients formal data

Operator

first of from the [Operator Instructions] Lee Stacy question And your from comes line Stifel.

Stacy Lee

have reception on to experience quarter. Stacy Lomb real-world you reception, our the procedure? as Bausch for but the been products stabilized on in using the commented for only others And with terms you VEGF for of envision on that are any XIPERE? competing extended that VEGF. can report or on maintenance and for? these didn't this Is has the far is you're Two Congrats And that the next-gen XX that then the duration anything way from CLS-AX, XX you therapy and have after + calling color a This that of provide ease can secondly, shooting product sales, Do X-month anything as X as adoption KOLs end. Annabel. are you questions envisioning overall are great field some of hearing the duration on patient project? do the versus

George Lasezkay

the do thanks right. question. for want with to Well, Bausch All Tom activities Charlie, that you Tom XIPERE. between -- address and

that. guys You are close to

Charles Deignan

on know, although and first, about but Papa, they some But and go the view I'll Yes, of Tom. comment -- his But positive KOL from sales numbers conference my around so to of over I give appears And All heard lot giving didn't sales and got we've could I'll imagine a then remarks. estimates. they I nothing as and haven't point on Bausch, they we Tom, conferences things at say Tom CEO, is didn't can could it from firsthand. to kick our partners, be [Indiscernible]. been XIPERE, product. Joe a it positive was interactions excitement very

Tom Ciulla

reception been The for really XIPERE has fantastic. Sure.

well. physicians Both like Lomb And think Bausch program train the well U.S. all program, plans so As complimenting I many e-mails this we them training feel congratulating the received uveitis retina well. gone U.S. country really the as it's the physicians training all unsolicited I've physicians. as and around to from earlier, program specialists quite retina is discussed Clearside, robust. prepares +

George Lasezkay

activity to inhibitors want on of maintenance and question, might and of a You in view part the address and use which use the kinase maintenance. our that and was second duration pan-VEGF tyrosine

Tom Ciulla

Sure.

a So good question. it's

limited. retina inhibitors, that molecule as And therapies, durability in found in small and the for think newly is studies. tyrosine the space more office-based that suprachoroidal becoming suspensions even prolonged what for approved therapies, of small and the is have aware, remains the noted molecule our community terms especially we more I kinase we've In durability, preclinical

mentioned question durability, X-month the not the shooting think I but case. necessarily for we're that that's

of of follow is trial have also X Our an trial, months X-month a a total for trial but extension up. we

than with In as is safety release. and less a has is coupled no of and that has There rules, inhibitory of higher with not X, borne suspension or high only study we potentially and inflammation, molecule because pan-VEGF And for within Cohorts know signs efficacy. has the safety this axitinib, terms propensity been suprachoroidal tissues biologic durability, signs feel we no therapies, signals. delivery X no we've what potency, we chorioretinal of a coupled Cohorts small were attributes for biologics seen stopping effective and our gene targeted but or well-established gene of safety out X the dispersion intravitreal think And drug with We intraocular axitinib to concern. in important therapies, is potential pressure has that inflammation data its as significant these a doses of very any these escalate therapy. X the been

small Of very course, is a OASIS with numbers. small study

So and terms we'll in visual be holistically very looking at anatomic all the signs. of data retreatment, acuity

Operator

Your question Needham from & Company. comes Rohit from the Bhasin of line next

Rohit Bhasin

talk This milestone you the you the Serge. you financing post can the talk level about your and on confidence time funding, million is based any on XXXX about you full prioritize for the lines that just you'll Rohit Can see that associated? of And discussed? how sales pipeline $XX then

George Lasezkay

first of take Charlie, probably the part take and part, do the want you second to I'll question? the

Charles Deignan

Sure.

for said, planning these agreement we we can't obviously, on As we other into milestones payments. what milestones. all the getting talk about the went this But

confident, it's XIPERE to feel going be sales. we but So based on

unreasonable cash. expecting guarantees signed the all and milestones, or on second was it. the can't receive fully but this not question of prior place But sorry, I they're we I'm to comment So really deal to...

George Lasezkay

something. you can ahead, Go say

Charles Deignan

got... you got You -- to no

George Lasezkay

that And into that focus say CLS-AX Obviously, is is is moving of to a further in the our currently number we product for really moving clinic if Phase most we going the data opportunities have our clinic, pipeline. important in just into OASIS the us. that the was supportive, I -- non-CLS-AX II. Okay. are

stuff other the in makes opportunities this to the really what to more see through those next plan number out going add and to beginning what come as end really we're it have have a -- and currently of year the the value. working we looking pipeline opportunities a at concrete to see makes several that and interesting we have, can for that opportunities of As of space. most opportunities we where the sense year of be prioritization we'll a pipeline, most on our And we the where suprachoroidal to create into

an pipeline, For interest us doesn't the platform internal with as use we from several and companies our their suprachoroidal that that count have injection technology. to

of decisions and a So we where it on creates and several move some will, value. prioritize ongoing can conversations number we the most and that we projects forward make the next have over months, what

Operator

Your next Securities. line question with comes from [Indiscernible] JMP the of

Unidentified Analyst

from Wolleben [Kathryn], question had a is data see on II This would II? Jon data I/IIa guys the behalf study. investigation what And Phase further calling Phase I just that Phase work JMP. the the I'm you into a of to for about from expect

George Lasezkay

address do want you that? Tom, to

Tom Ciulla

Sure.

seen have I mentioned important our earlier, first really we've earlier, study safety in initial And I OASIS remains retina as inflammation. because mentioned with So these some priority other this days therapies as problems first-in-man in safety. is

it's safety looking of a number other So we're the holistically But therapy. at study. one, also aspects

best OCT including and need well anatomic we're [Indiscernible] for visual parameters, retreatment. stability some on [Indiscernible] looking geography as based on at acuity So as

molecule. well-established a is axitinib expect, we what of terms small In

less X in And was as So Cohorts borne propensity for I X. mentioned earlier, there's inflammation. and that out

were also target think We of axitinib. higher with that and model as evidence preclinical than impressive pan-VEGF [Indiscernible]. then the us effect can So to potentially the finally, [Indiscernible] last We choroid through the high durability, retina continued year, X with several in VEGFA suprachoroidal leverage efficacy and pharmacokinetic log of to levels orders with to RPE paper out X. published the receptor this these doses, that a to months for focused we've inhibition. inhibition. delivery, see have are that that further a seen ability levels we benefits And we pan-VEGF in And very studies. we our our couple safety the break ceiling higher And of and allows expect we're in looking for durability showing at rabbit there ICXX VEGF in that we some and the

holistic parameters So primarily, hoping in safety based durability. retreatment we're BCVA, looking for of as anatomic signs summary, but well efficacy we're see on and also as to

Operator

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

Yi Chen

target the future So in or anti-VEGF clinical change treatment-experienced the always sub-responder in trials a population we future of CLS-AX, patient trials? patients could highly

Tom Ciulla

that. can I take

in at a have that's we're have ourselves question. set in by first-in-man independent screening, treatment-experienced we insightful high requiring center. We oftentimes, for patients, that's an experience highly and trials, as you'll trial, these many bar treatment a the -- really applications. But current that active So and are reading confirmed disease because

in sub-responders. sub-responders we're they're testing essence, anti-VEGF numerous prior to So And treatment.

high So study the bar, we're but is a again, setting geared safety. towards

Going learn follow feel set we we suprachoroidal criteria. to don't more forward, more eligibility compelled as about that of and axitinib, exact

for this than inactive So potential disease, biologic we going forward. that active patients assess at better trial the effect But least by with in a may have had requiring for to patients if disease. have study we to change

Operator

comes B. Instructions] from William the of next [Operator Riley. Your line question from Wood

William Wood

local to experience coming response, maybe cetera. could today. Wood maybe providing of out animals, on if immune Mamtani little color PK Riley. profile in the et news repeated [Indiscernible] B. at curious your share see Great on you I a This for dosing good is give the William us just was extra

George Lasezkay

Well, we've question, repeat think Tom, preclinical say in terms safety safety Add about we and to past, in what but your some careful our would dosing. that color that, the internal Tom. somewhat be of I been

Tom Ciulla

cell we pristine. current study the has profile as earlier, for gene I as the dosing. for molecule, preclinical been about earlier, We far, we'll axitinib already propensity inflammation. less Obviously, approved studies. forward, think repeat so the using dosing And mentioned plan use. move And I'm GLP And dosing to as is supported tox support will I it including or our a safety carcinoma. we're mentioned by molecules we is Sure. renal that repeat suffice say preclinical therapy. inflammation have have safety you to approved that And asked biologic compared a we small studies an to studies,

and summary, the has with humans the been in single pristine. safety So profile dose in robust

support We dosing. hope expect a as because molecule it to as be we propensity inflammation. have data with And preclinical and that continue as repeat data well less it's will the small said, OASIS to of safe I

William Wood

Appreciate that. And may. if then extra, one I

got X, of obviously You've expecting? Cohort later X a be this total color could you're reading you if out if X in we'll even year X on Cohorts what Cohort curious -- data months open-label give we or maybe November. X? from little any Specifically, I wondering see extra was a us for extension X, I'm may

Tom Ciulla

So do have decided X. Cohort an study extraordinarily X an we to low we -- on not was -- didn't we done with don't extension Cohort dose.

X for suggested We and X. Our but study X from the the that XXXX. along Was Cohort the include do quarter to from data be X. decided Cohorts a question? first did X. read second from The and Cohort X X data and the to X-month different in not We'll in we extension out report extension in there November, preclinical extension extension Cohorts study studies with we X, data of will turn Cohort part that levels, would have for out X

George Lasezkay

just I November. be color believe in general we on No, what may expecting

Tom Ciulla

Sure.

X, the set and by of heavily high in believe, mean year ourselves. had in reading I despite treated, And was for X center. activity are prior patients On earlier, we injections, the in a independent average, injections prior the persistent being they patients. the to treatment-experienced on alluded Cohorts as number bar had confirmed X. So mid-XXs heavily very of as I These

we said So We'll sub-responders. very starting at we'll patients heavily a be retreatment. assess And active require looking on anti-VEGF patients bar be we to anatomic earlier, those bar of set and the inactive a that high OCT ourselves. It'd We'll angiography, we of treated biologic based and we're looking at very don't potential And holistic be many essentially with effect biologic for assessment. what going at to think are patients needs effects looking approach our a to These as for I higher by to for screening, have as are be this at acuity. visual assess effect. treatment. because have therefore, difficult

acuity, also readout be will very X had cohorts, visual we'll best color central all parameters the some subfield -- past, to OCT thickness, provide as angiographic just be retreatment, with the So may well because and we'll We'll analyzing we respect the as parameters. transparent. include corrected in additional as

Operator

I at now back conference Lasezkay. this the I to questions like would turn no And Dr. see further time. to

George Lasezkay

summer. thank I this interest on everyone you want call. and the your to us that Clearside, I may continued for now really rest appreciate in of joining your the call morning. Operator, enjoy you We hope the disconnect you. Thank

Operator

for you This your conference Thank call. concludes today's participation.

now disconnect. You may

Clearside Biomedical (CLSD) 9 Aug 222022 Q2 Earnings call transcript