CLSD - Earnings call transcript Q4 2023 | Clearside Biomedical, Inc.

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Operator

Greetings, and welcome to the Clearside Biomedical Q4 2023 Financial Results and Corporate Update Call. [Operator Instructions] Please note, this conference is being recorded.

I will now turn the conference over to your host, Jenny Kobin, of Clearside Investor Relations. Jenny, you may begin.

Jenny Kobin

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

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

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

to elect so to obligation these update disclaim in views forward-looking do specifically we the change. may we While future, any even our if statements

Lasezkay, Chief formal and we Officer; our have Executive today's will we questions. remarks, Officer. On Financial for open the George call, your Chief call our After Deignan, Charlie our

George. I to the like turn call to over now would

George Lasezkay

trial Thank has you, study XXXX us wet afternoon, Jenny, we year, positioned supported progress program The development CLS-AX extension results Phase year. in initiation advanced budget. and important for XXXX, Last line propelled us an into our of and from In in clinical accomplished that targeted February IIb our and OASIS time ODYSSEY. AMD, that meeting we our positive we our tremendous clinical good XXXX everyone. reported

of clinical of and was and ODYSSEY time and the physicians we on year, in budget. primarily significant our impact rapid potential because from line initiated aspects of that This program. Later enthusiasm compelling enrollment the again, a result enrollment targeted completed

X Collectively, our of for X are now with indications. programs. in there licensing progress each development suprachoroidal XXXX, clinical partners delivery development different their assets excellent clinical in reported During

to SCS to pipeline. deliver of orlistat BioCryst asset another to edema. our addition, to a In and their with macular our another treat we new compound announce utilize to both collaboration diabetic Microinjector indication Pharmaceuticals were pleased adds proprietary This collaboration

look As we Clearside will key execute a year for we critical areas ahead, of on as XXXX focus. X be

primary the will in IIb this year. occur quarter third ODYSSEY our trial readout Phase First, for data

Second, demonstrating partners into our the drug expect to our we benefits SCS of and space the device continue suprachoroidal technology. delivery Microinjector with

active start double-mask controlled participants clinical in wet I'll AMD. with ODYSSEY, our with trial randomized

We are inhibitor suspension technology suprachoroidal patented utilizing our kinase molecule deliver injection the CLS-AX, axitinib. small tyrosine to a of

that for of a therapy ODYSSEY, combined excellent results AMD safety the will our profile, the extension mechanism the offers method of potential CLS-AX. to frequency delivery stable ODYSSEY replicate observed in axitinib over Phase high pivotal proven efficacy OASIS with CLS-AX X from we long-term differentiated be reduced The of to are design looking injections potency vision and and safety months development patients. the Our support action maintenance III we In study. our of and for wet for program

from XIPERE evaluated Singer molecules, to Academy Registry think outcomes his This nearly was Ophthalmology XXX Dr. claims month. last open recent With and suprachoroidal usage. extending focus Michael data. treatment In Singer source of eyes utilizing the presentation, our I positive Macula duration, by it's Society IRIS at American delivery analysis utilizing Dr. presented relevant highlight the small Meeting real-world on of

for from dose Phase the over with one pharmacokinetic the data after where of XX% X require just of trial. did is data and real-world This showed retreatment XIPERE data XIPERE. our consistent This durability months PHX eyes clinical III preclinical not excellent durability

drug for directly and SCS approach suprachoroidal patients reduced microinjector. delivering Importantly, treatment we small believe molecule Clearside's by our space release this analysis extended the to to burden with validates drug

adoption the progress the last back over leading look suprachoroidal and acceptance delivery. several we of years, I'm with we thrilled have the to As seen

Category delivering a pioneers coverage. the injection This behind led X and space, way approach the procedure code CPT adoption for this As for to retina. The the proud access, original important visual and has innovative permanent we is are the technology Clearside's drugs of the that the insurance facilitate directly major available in suprachorodal better now help itself. CPT to a for procedure has code milestone field

in-office the Most SCS trials safety Our as profile has ongoing proprietary with with by and the profile to visual suprachoroidal to demonstrated injections X,XXX microinjector away is approved reliable, a injection safety keeping fact use field. nonsurgical with and delivery performed its space compartmentalized XIPERE. this continues enable strong microinjector in our drug tissues behind is in it the clinical importantly, believe from SCS due delivery our SCS to part shown multiple simple entirely commercially that positive over nondisease drug product, We date. in

with over of drug for vitreous, inserts suprachoroidal or complete over We the to physical have and We drug time. suprachoroidal delivery for we've allows that the not in Difficulty] to SCS place behind our risk companies retina or toxicity eye. multiple believe vitreous back vitreous date, become do we the not limits delivery to gene do of patients possibly floaters, anterior vitreal utilize that or put choice erosion ophthalmology. delivery established This chamber to rely on of partnerships into the Since flow other elected therapy with may biopharma and Microinjector who injection impairing the the or interfering method the leading the bio [Technical methods. gels the

X development who XX of partner, using steroids. topical gene delivery intravitreal from in our AMD in therapies their inflammation received microinjector, inflammation recently has prophylactic other clinical despite wet shown just in weeks. SCS trial has demonstrated contrast, reported X prophylactic data treatments were In our that of there observed Utilizing of weeks steroid REGENXBIO patients cases over

and inserts. These steroid steroid oral injections, in some extended medications cases, regimens involve release

their prevented one in year. last DR trial has So In we're progression X their altitude from patients about microinjector. that presented retinopathy, made at our November RGX-XXX progress programs the REGENXBIO excited nonproliferative SCS in utilizing REGENXBIO showing diabetic data disease

In treatment a demonstrate retinal and data currently protocol presented in the mid-XXXX. burden January updates the REGENXBIO assessment or and use they anatomy patients XXX X meaningful QX AAVIATE participants enrolling Aura of data and their bel-sar for of trial trial, adults new altitude suprachoroidal with for which efficacy their year for their this exclusively to in written a trial, III of treatment to vision XXXX safety that from under AAVIATE showing program stable is design in early-stage agreement with is CoMpass trial at wet continued over this reduction trial. Biosciences in months. chose expects in treated choroidal with CoMpass AMD, special intravitreal share injection to X melanoma. first-line delivery is The of covered evaluating FDA Phase in and the trial the

also as to they forward Arcadis. which are XIPERE, have by We progress our continued Asia looking developing branded who's partner, Pacific Vision, Arctic

completion of Phase will in China include their in and year I edema This DME the trial trial. uveitic macular from III Phase data

worldwide we the a plan the provided of in and for $X drug us new development, delivery use In molecule. license license Last their small avoralstat November, Microinjector other they BioCryst application their partnership an fee additional the territories. SCS most with of plasma use our This new announce with upfront addition, NDA into of proprietary exclusive inhibitor, million. Australia submission results our for SCS entered Microinjector recent the In to an partnership with in of expanded Asia Pharmaceuticals to kallikrein submissions Pacific we DME.

sales. net million Additionally, the product on mid-single-digit tiered includes and project regulatory -- milestone $XX.X agreement net clinical, sales-based post-approval in royalties potential and payments

with We target closely this a clinical formulation are working with work of conduct work BioCryst initiating BioCryst as team in XXXX. year we the collaboratively and nonclinical

We encouraged are suprachoroidal the very all programs. progress development continued by X in collaboration

provide financial over Charlie update. Charlie? Deignan, the our to now will a to I turn CFO, call

Charlie Deignan

Thank everyone. and you, George, good afternoon,

for are Therefore, in press quarter were the summary and year-end results will I financial call. on a provide published website. XXXX of today's available our Our only status and on fourth release financial our earlier our

operations generated As in Subsequent completed the of With the million registered approximately December cash end quarter, combined proceeds. XXXX, and anticipated Phase balance the to we warrants, which takes this and of totaled of fourth planning $XX cash XX, of us offering million. cash gross the $XX trial direct our we stock ODYSSEY This a have resources into our our third this we for will III supports to equivalents planned program. for CLS-AX fund readout through and the XXXX. data year believe quarter sufficient

updated terms be look investor we of participating Citizen Healthcare Conference. progress. keeping In investment our Science and Conference on the will outreach, in Life upcoming JMP community forward to Needham the We Securities

now turn the his to I call over will George closing for remarks. back

George Lasezkay

Thanks, Charlie.

have highlighted, of we key X As year. focus this areas I

readout third treatment year. may expect line IIb a wet quarter in data valuable We regimen this that complete that the for believe wet to data AMD the patients the of could Phase our trial CLS-AX AMD. We addition with ODYSSEY clinical and be top demonstrate report to in

our suprachoroidal companies diseases. developing the would our vision microinjector. the for with In with living space questions. open delivery care for leadership our leading new call I operator ask we health benefits to addition, We in with to continue improve as collaborating demonstrating generate steadfastly data drug treatments like remain partners and to additional site-threatening SCS individuals now the to of the committed we'll and

Operator

the Samimy Stifel. live. [Operator first is Annabel your from today question Instructions] is Annabel, line coming from

Annabel Samimy

Ocular non-inferiority picture. now was guess of just significance you can doing little confuse things little Eylea But not to loading duration. it's you for just I hoping [indiscernible] identify trial. a other as II me. how for Congratulations of yours general, or not the loading inhibitors, That's bigger maybe the is enrollment. but that guess for TKI treat rapid you has X each great. I is on these yours, dose noted the Therapeutics just designed, statistical the it's more were was powered I really and doses, trials yours something Phase in a Eyepoint superiority obviously, then just to one bit clarify And

how but and point at might the read question into supposed there to need treatments, the between So I our And data really these to trials, all TKIs? for different of think are some choose be these landscape we physicians, therapy. how you you as just these right, is, a understand fits evolving for what harmonization do not it clarification, all guess maintenance for

I this you discuss little sort of was picture. more hoping can big maybe a So bit

George Lasezkay

mean, I trial I to to -- you raised. to right loading doses. I will in Phase I'm process II heard it's be Well, be, [indiscernible] perhaps needs interesting not something say point there doses, the over you loading to our think an but time. need harmonization X clear, be sure some does X now is There We're be there that just

Annabel Samimy

[indiscernible] before yes, sorry. your injection,

George Lasezkay

bit to little with Ocular dose a -- of theirs they're But of We'll of loading things. what understand basically the there's process third dose to done more loading and they've try us why next be injection that begin see about our or loop like. later. our then in to in second CLS-AX couple the now. a the thrills concurrent I month a kind and aflibercept to each Yes, pivotal process because over program needs we're learning retreated. I'm it is harmonize then now more would of who way. to and dose, really the just it one waiting and And discuss doing We're thrills months look

harmonize would of with do get or the superiority. so how being doesn't our is our III, administration go in like dosing and III. question, but ODYSSEY about duration, us that Phase these really looks one clearly Ocular into we'll want come each we it where regimen And best is different we is anti-VEGFA, when to design. what or TKI slightly disclose at for to aflibercept we in think using timing which or Phase because Those match We're if up other we're we a right the used some EyePoint do slightly going we trials your very to TKIs differently. is with are for looking some are you're third see is up And going But noninferiority. differently. design measure how one we be

bit ocular, doses as loading deal And be the where TKIs fit the a we having going work, is big begin treatment that So with problem. but time see learn they're a appreciate harmonize, more come thing and going to I can to a this patients. naive together. the you're I think about I how after But of that to don't think necessarily over are where you'll in, they

they to I'm going with see I'm we'll what this little so guarantee but time, harmonize, what between And do can't a why and on-label the a bit I -- why understand different will to happens. they're X loading way, do But didn't studies. a you I aflibercept. it puzzled I we're over think see little bigger, think more But I trying dose bit

think treatment group a for the a physicians that wet addition be I important inhibitors alternatives going as you tyrosine very particular. have that in AMD to patients see will are kinase their to the

to -- we I very treatment out. think X you companies, to come the you're think think physicians believe thing. if have don't to I that's most place other as have clear that in that I going But we be I to to think regimen. they And we're the well. believe that data I going talk think see that of to a same for the we talk would wait And that. the

not but -- compete form they supplement binding don't help -- different nicely But of see the slightly very we it have effect, receptors very anti-VEGFA instead and circulating So it by with they have anti-VEGFA we to you're go can with the to to of going may because we competitive, competitive just me, action blocking duration, kind demonstrate have all tyrosine VEGF a excuse think kinase inhibitors and mechanistically, I that they demonstrate in have way. they're of and very out mechanism

So theoretical reason there's work. they why should a

through in for I clinical clear. think our indicate the and we duration I to be trials going as seen have data all TKIs extended trials, we've very all go that place they additional the think our is of that clinical

Annabel Samimy

And question if that. just can more add I one to

-- TKIs mindset the of be to as that and ocular kind is if in of landing Does therapeutics they're blow with will this discuss maintenance Or naive? going this it that far treatment you of What's sort retinal where served? seem are as what's where at TKIs the community. As looking domain? essentially best more anti-VEGF their up treatment serves

George Lasezkay

they're everybody treatment where will and this naive. this going studied maybe we've Again, and change Ocular Where studied things.

therapy first that is their always works. see after drugs duration most insert in think their we'll But the been the therapy but So most they're they first-line I months therapy draw that believe, in to we X the how early look and now we'll people mechanistically, would should you than affect way where is or even to on very is treating their see trying this show the an think people right can depressed I vision, that maybe where us tell ocular doing one how the at put trial. that that antidepressant of to in treating as better But particular, not should at better I nicely. look where In have it more work monotherapy, are TKI anti-VEGFA extended I vision maintenance works you're who comparison, therapy of will outcome, know. us making depressed. cancer, or And couple complement go. cancer I [indiscernible] people maintenance in. the most don't chemotherapy improved They . I another.

in And different to They've the of antidepressant. same and haven't from mechanism approaches They that. so even had days physicians of Eylea and Vabysmo. chemotherapy cancer action multiple have really multiple had [indiscernible] the old approaches

principally anti-VEGFA That they're circulating allows all for get overexpression That of going doesn't that the account care circulating. after of So the doesn't C&E for it. that's VEGFA taken of binding approach.

C, and finding drugs could E A, VEGFA blocking overexpression receptor by at I So X there's the work together very level. circulating that the nicely think if

wet I the And therapy them than seeing company AMD this we'll think a look it see it it's complementary patients approach real think as right a one approach. complementary I look to So replacing add at from as I other happens. over the see I the should opportunity rather at gains think and think should I this this. I what physicians But And very will of as start, beneficiary think necessarily. main be usage, time, complementary to

Operator

question next Jon is The from coming Wolleben JMP. from

Unknown Analyst

mid-stage clear I Ocular, some compares on one suprachoroidal compares your questions studies? just And ODYSSEY other This population that on how the for on generally how AMD candidates. know trial. side? about that AMD you about administration you is wet another think to of just Catherine the few other just approach talked [indiscernible] color that. on how And to then on wet safety

George Lasezkay

very attempt diagnosed wet AMD had, were with In more ODYSSEY, enroll had so or treatment determined some a been patients made less to lightly we who they experience, had treatment-experienced.

documented fluid So And they fluorcinangeography. weren't make was that or leakage patients that naive. were tried sure presence either importantly, or fluid to or that subretinal they we've the intraretinal of on had both

So what -- make of the were don't concerted patients we was to very we sure a companies did TKI done have other we know that effort that the but any -- made this, some who enrolling had that we're they enroll but did into the patients to had hard to try on diagnosed, not experience, dry. not enroll fluid but clearly been very We have were want enrolled had and trial. other

And because trials that's for patient, previous and real months. positive right not companies certainly in degree any may many can because been in artificially intervention there it your results the the of kind patient inflate can case they to get dry you by some other and require see and

So anti-VEGF sure some past, had than in but we but you wanted patients would they -- a our might that weren't super in lot were KOLs are to more they required were were responsive, had make therapy, trial like to that fluid addicts. -- the patients responded intervention call OASIS our anti-VEGFA needed our degree the that They expect.

their you Eylea's or would expect. Lucentis far their So than frequently were getting more they

presence of lot overly had So the on reading there, -- weren't fluid the they a independent some documented in documented anti-VEGFA experience by patients we center. dependent and that enrolled trial, wanted some when but response, of presence had had

thing criteria, the that careful but us, that's companies believe we very important to been the other do. that to for to So that that's about tried know us we've thing enrollment do. have was I that right don't and one

You had issues looked at to Phase our injection complications you very had in of we suprachoroidal terms had safety? But had had of in From in injections from luck find second procedure itself, inflammation they're We've question good a results no limiting with OASIS, there. intravitreal very on and we safety the perspective. were injection very, OASIS That if I/IIa the safety patients, it same. over at aware was on particular We've essentially We safety? in good. compared dose trial. time, We've just no a that that issues our procedure no look view, point I'm safety toxicities. of of the injection an the

so And injection suprachoroidal from has the safety very been good.

With anything well, an it's not prep the for The them. same is and for profit physicians intravitreal issue clinical don't demonstrable and safety training time at compare patients between the intravitreal looked there it a do see difference would for injection, and was really it be of we big basically trials as a and no gone we've both. them quite in number and back suprachoroidal when

very So itself. safety TKI, the feel good the good about We axitinib safety itself. we of about very of procedure feel the the

so your to answer question. an And that's -- that's hopefully,

Operator

from next Serge from coming The Belanger is question Needham & Company.

Unknown Analyst

Hi, on I'd This couple everyone. Serge. hit of to different John a on for is like points.

back the trial. OASIS going to First,

you of for potential X guys degree CLS-AX, obviously retinopathy? additional this the to have AMD, dose. moving which whether not at you past of for patient dropouts? it early are off being the like ODYSSEY, things are of going diabetic a expectations any need You trial down. at degree to kind guys milligram or where protocol color to be stands point And whether kind the the had higher any your guys slightly expectations into if reflected indications rescues explore then is you wet starting use mentioned for have or this in of higher Knowing patients any for there at or And DME least

George Lasezkay

last DME CLS-AX. the one for now, first. answer any me we have don't DR to look into Right Let plans or

entirely go looked at things. that rescues on off AMD. we were back a the to So Oasis. early we're When protocol couple efforts that, I focusing wet we're If in seeing there our of

the so there injected first it into First AMD open-label tyrosine And time the people blinding these in an suprachoroidal wet kinase was was involved. all, that trial, no it of patients. had space was inhibitor

for X kinase X the no basically So was nervousness, jumping I tyrosine inhibitors rescues, there bit we they with but about a -- rescues early reason a early But X why X.X with there a in site the think there's investigator. for was in had rescues. and best first it think some mean milligram was had we that. issue. a we dose, I kind reason issue when I gun it. majority the Cohort of experience of X and were in the when or little good X the of have was I couple . And not having milligram that in And in on Cohort couple to injecting kind the looked that a cohorts seemed site-specific specific protocol and about milligram There was they X, X, of that should in kind really month particular early And didn't. nervousness it these any at think, of and no can same more looked After X. rescues was tell logical that of milligram the dose, protocol first be a little site-specific Cohort of it

don't designed talked -- our ODYSSEY expectations. about -- we trial we've So you not to

our Our of with criteria. and on-site through which educated retreatment in of expectation that number very to sure well is sites protocol, our our should not very materials the a training off our see hard and very limited and we make they're worked terms people we

that very that, has about nervousness dose, X loading second ODYSSEY dosing early addition, Annabel eliminate second doses this loading -- rescue. a And with about of talking the we think, we as earlier. the In and will on I aflibercept, trial think was any

don't rescues have of early an expectation So we really here.

going going the of I'm blinded have that. to data. clear, expectation patients are extended and on no we're to treatment. to insight be see I an into just regimen, well the totally have We do very that quite And duration this on

met not. I whether no being expectations our what idea have So are -- or

So out those later year. they're expectations. know are we'll I but this my met, find whether being don't

Unknown Analyst

have And real Do if sales? and any I XIPERE regarding far so on the guys quickly. how color can just is you performing follow up volume

George Lasezkay

XIPERE?

Unknown Analyst

Yes.

George Lasezkay

one, want. Charlie, I'll that you if let handle you

Charlie Deignan

Yes.

we sales, we So previously, of again, talked as can't get [indiscernible] until ahead them.

$XX from that's If in royalties. sales excluded million XIPERE from first you remember, the

get So past don't million, to until that $XX they any . we have revenues yet. report

Operator

Thank you. now would turn closing to time, George call Lasezkay, this Clearside's remarks. And at like I the to for back CEO,

Charlie Deignan

George, issue. you have phone maybe a

got You it?

George Lasezkay

I on I'm I'm mute Yes. here. sorry, was for a minute.

Okay. Well, I forward joining on may interest want Operator, call updating continued certainly your Clearside, for we progress. you to thank discontinue. the appreciate our in everybody and We to us you afternoon. now this look on

Operator

conclude Thank today's conference. This you. does

your a and may You you your participation. Thank disconnect time, this at for day. lines wonderful have

Clearside Biomedical (CLSD) 12 Mar 242023 Q4 Earnings call transcript