OCGN - Earnings call transcript Q2 2024

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Operator

Good morning, and welcome to Ocugen Second Quarter 2024 Financial Results and Business Update. Please note that this call is being recorded at this time. [Operator Instructions]

I will now turn the call over to Tiffany Hamilton, Ocugen's Head of Corporate Communications.

You may begin.

Tiffany Hamilton

good and operator, you, morning, everyone. Thank

clinical Corporate Chief call provide on Medical Musunuri, questions Ocugen's me a update be to of update on Officer, a XX, XXXX. following the today's our Michael ended answer who the will call Shankar Dr. business quarter our overview June an also is webcast the Dr. and Controller, operational Chairman, financial provide progress. Breininger, and will Joining and CEO is to Co-Founder, for Huma presentation. Qamar, available and

call business on website morning, operational of days. replay a a This the Ocugen to which for at available issued press accompanying is we the encourage XX with the This on We for release review presentation Investors quarter being detailing second recorded, available will associated press of approximately be release, website is and and the the section slide listeners highlights our XXXX. ocugen.com.

the or events SEC. numerous subject the activities presentation should update may cases, that obligation or information, and use described are could, in periodic the this to presentation, factors This uncertainty risks related in or are of of expects, described as continue, otherwise, statements statements we factors forward-looking convey statements events and actual development clinical statements and and some this anticipates, We in the are uncertainties presentation to as Such the risk include, Such of subject contains to statements. anticipated expectations. we that the speak Factors in Securities results with but future may, and Reform Commission, of no outcomes will, date only reports words and with quarterly except in events may, as are within make SEC, from new cause forward-looking other our by this these identify lines. the risk materially to, not plans, estimates, regarding uncertainties. more meaning important terms our might, whether of limited result to current section forward-looking Any to in uncertainties time file the Risk Private which contained the Litigation intends, presentation, or Exchange statements and These entitled annual our believes, forward-looking XXXX, presentation. including other proposed, differ potential, filings projects, Act date of future such risks that assume statements that required we a of as after this fully law, Securities

XX-Q filed. Finally, report quarter Ocugen's Form quarterly on of XXXX covering been the second has

I over to will Musunuri. now the call Dr. turn

Shankar Musunuri

programs. and today. progress thank substantial all net we to clinical this We're platform XXXX. third of million, for program, to of across discuss And therapy all you, you Thank proceeds X our successful driving of excited continue runway the the into completed quarter recently joining with a gene effort extending modified our Tiffany, us fundraising $XX.X

ranking of advances acknowledged inclusion long-term demonstrates to the Ocugen's in dedication the company in Index further scientific strategic This our of by the supports Russell growth June. value. and Our and value pipeline the shareholder were creating

strengthens recent fund, participation sciences mutual base. premium the from the led our Additionally, leading which with by was along investors, offering life further a shareholder

first-ever OCUXXX. treat with of adult older candidate the RP gene is for RP. our for EAP. of FDA the RP And for We're patients expanded to of announced access liMeliGhT EAP, approval clinical for just therapy with the and actively treatment regardless in trial we III this recruiting an Phase week, patients This XX treatment mutation aged patients, program, OCUXXX pigmentosa, with retinitis approved

in following OCUXXX in clinical geographic of atrophy, Phase in age-related of an will advanced macular I. presentation. for the into degeneration, patients I II these later trial dry depth pivotal progressed milestones greater stage in of treatment ArMaDa also the We Phase the discuss dosing completion

OCUXXXST clinical of about I conclude Phase I/II Phase GARDian to trial are of for we Additionally, the Stargardt the disease. treatment

remarkable actively patients III trial. Phase the is are and dosing strides clinical clinical liMeliGhT we development, in OCUXXX making in

orphan market dosing, received As application, XXXX FDA the to has a Medicines BLA, OCUXXX licensing announced from FDA. key With European from advance regulatory Agency well earlier, approvals, OCUXXX meet including for for designations Phase designation drug MAA, from regenerative III the medicine the biological and European from the targets Medicines as remains expanded as a at the and RMAT track authorization approval application, FDA RP, Agency. on the therapy,

III responder that intent-to-treat rate. product patients III test including The encouraged meet the Phase III. The established is very Phase the for the responder mutation, the I/II RP for are XX% more only criteria patients with Phase RHO trial, XX%. X from XX% FDA-approved of than We than clinical treat mutation was study better to in mobility rate XX%, powered Phase assuming responder

adults navigates function sensitive baseline. Lux proportion Phase study untreated III arm includes liMeliGhT levels age an mutations of endpoint XX trials. more III of the of improvement and stages genes, to randomized other any a early the a who study. still of that has test, study XXX mobility III groups, measurement has previous in One Phase clinical specific the the the obstacle has in this will than older navigation luminance used several a dependent RP. In years study of responders, from the and X:X. gene measurement least arm constitutes X LDNA, achieve is an in RHO of and and patients, The other treated mutations advanced with pediatric participants on course focus size of The primary participant or assessment, the assessment, participants. with mobility In at with visual XX participants The intermediate X of OCUXXX sample Phase

disease, and which the the of any of will mechanism XXX associated a is by genes. treatment X to the gene to approximately patients. action. U.S. addresses moment caused for gene in need. market that are approximately fulfill potential take And different patients in a market mutations in on RP. by gene-agnostic XXX,XXX The only currently the unmet me way, are need significant has mutations its discuss Let it this EU There OCUXXX RP unmet with underserved mutations affected in of medical and the treat multiple other because

of continue of data our Meeting convened such extensive American And Annual campaign of community We in therapy. conferences modifier to ophthalmology a the concept Stockholm, Specialists, indicate of supporting the variety the which as recently of Society Retina gene presented Benjamin about we at Medicine Phase in Associated as the and I/II on Retina At OCUXXX. College Phoenix Dr. Sweden Research last and Bakall, of clinical month. Arizonas, data Clinical of who presented as Consultant professor the at University Director conference, the servers assistant

with OCUXXX, least the the initiation and modifier and to the minimal benefit RP with gene eligible novel eligible prior clinicians, We provide access to OCUXXX decision the tolerability the to for to EAP approval With community the supports The of preservation of our to our to from the agency's on and treatment. of profile mechanism any risk BLA. the for program therapy. by retinal The patients an advanced who position in for mutations RP OCUXXX action receive to treatment of access of patients intermediate to use patients endorse relative may of for look OCUXXX early action our with at of gene-agnostic RP EAP. FDA OCUXXX any with this reflects of may further any be safety, patients forward the working approval mechanism of through for expanded OCUXXX benefit RP

a secondary single with geographic developments OCUXXXST, atrophy, These for orphan let's injection. which Now life sub-retinal to dAMD receptor nuclear a to RORA, aim OCUXXX RAR-related move in therapies therapy treat as called on a onetime leverage disease, which respectively. receptor gene our A, gene to and potential and start our for stands modifier

designed the in the a implicated of to doses has distinct treatment developed system, stress, XX% injection, only injection. metabolism, address concerns, related complement the complement system, about regulate frequent to and of addressing advantage potential to patients all one require intravitreal disease that specifically disease by X OCUXXX current oxidative single to safety wet and inflammation, causes roughly thereby dAMD, of underlying multiple a pathogenesis sub-retinal AMD. X lipid the per pathway, OCUXXX year, offers XX with the options target as the progression, accompanied such pathways various for pathways

safety trial On insights of providing clinical update, this further the efficacy OCUXXX and is into ArMaDa anticipated year. later

provide million a U.S. and and solution comprehensive Our prudential a There with are durable by OCUXXX opportunity. in among considerable million to treatment. is the dAMD to million geographic atrophy demonstrating approach X the people affected Europe, one-time a with X market patients XX

atrophy the clinical announced SSR-blinded treatment July, of I/II have been completion X for In II patients of and in group high efficacy cohort a who X treatment patients or XX randomized dose be will control a groups, or of a between letters like have be high-dose millimeters. medium is be at group aged X you group, clinical treated initiated a safety with the Participants with of trial group. atrophy. will Today, which older, XX.X atrophy treatment identify geographic the third X.X been must into the OCUXXX geographic Phase expansion, a XX dosing geographic square the to medium trial Phase we a in able assess on and and or BCVA, ArMaDa OCUXXX doses. read charts and optometrist's dose has area more and those The of larger low, total the of office

treatment Orphan an of XXX,XXX from treatment is and the retinopathies, OCUXXXST, the Stargardt available. of Europe, including the The approximately to I/II affects Stargardt high-dose the for U.S. enrolling which people patients is study. now Drug of Phase no ABCAX-associated portion trial escalation in Stargardt the Turning approved GARDian FDA in the disease received disease. therapies dose and Designation for actively the there clinical and has cohort

innovative forward advance treatment as promising benefits that development. These We we to continue sharing solutions focusing patients. these provide therapies of to through lasting to gene to blindness, commitment represent clinical our look on efforts therapy aim further to advancing updates

June will our Michael over on update the I that, second Michael? Controller, Corporate financial now an XXXX. Breininger, for ended call provide our results turn to quarter to the XX, With

Michael Breininger

compared equivalents $XX as company The XX, as stock XXXX. XX, of you, restricted outstanding and June The cash, as December company's $XX.X cash totaled of XXX.X million Thank common million June million had of XXXX. Shankar. cash shares XXXX, XX, to of

ended million. This June million included and expenses of that of research and million, total Total months general X million. were the compares expenses million ended administrative the administrative X of expenses to included operating $XX.X and $X.X June XXXX, general of $X.X development and expenses development XX, months research of XXXX, and and for and $X.X million, operating XX, expenses $XX.X expenses for $XX

completed a successful we XXXX. into runway $XX.X with As our quarter proceeds third fundraising effort the earlier, extending of stated of million, recently net

the for our are drive to increase update always, pursue long-term capital opportunities and quarter. that As That you. back partnerships to working continue Tiffany, will and we shareholder-friendly to concludes constantly strategy. exploring strategic strategic my

Tiffany Hamilton

Thank you, Mike.

We will open the for call questions. Operator. now

Operator

Our Sean first line comes the question Instructions] [Operator from of Lee.

Xun Lee

This program. is for OCUXXX standing the is access Wainwright first Sean RK. from My in H.C. one on expanded

So was of towards is EAP actively primarily I'm targeted since patients III what sure wondering lot you Phase into the a the are recruiting study? I still

Shankar Musunuri

Huma?

Huma Qamar

you for question. the Thank Yes.

is not on of population the they So that our would that in mandated to regulatory based III program a Phase the not Phase is III process. FDA bit targeting expanded an do have by or meeting inclusion/exclusion because our option the flexibility criteria what have we offered access meet little more have

has the photoreceptors criteria is who this would of physician be the taken will that also treating trial, by individually age, the of be clear have treating diagnosis decision XX anyone by this certified in patient. left. discretionary those the genetic and that And our and inclusion physician, years RP So a

Xun Lee

to is And difference the arms? expected the what disclosed wondering, I detect you treatment between untreated how OCUXXX it? the Phase have was I On the study to powered see. what's -- III, and

Shankar Musunuri

Yes.

So SSR the surgery. is treated because It's and untreated not a truly untreated. blinded study. Untreated sub-retinal it's

So blind the way you're that's study. the actually

X:X than study a out And is the response at ratio. patients, That XX%, going means the so -- rate. of there study XXX in untreated powered are second the the at assuming XX So powered patients to greater group. XX% be is is

the on defined are either reach our higher levels responders who is So test, LDNA. X mobility which mobility tests proprietary can as or

Xun Lee

Understood. Okay.

little XX% to then What at study it. more Got detect update we expected will a difference. provide? can And So of you this kind for deal you what a update? later year, on What would expect the XX% the provide? finally, elaborate could OCUXXX Yes. you

Huma Qamar

geographic atrophy for degeneration age-related dry study. XXX yes, the macular secondary So to

year. this are and provide safety to later We hoping updates preliminary efficacy

Xun Lee

we efficacy then? So and results expect both some safety

Huma Qamar

Yes.

Operator

Our line Robert Capital next LeBoyer NOBLE with question of Markets. comes from the

Robert LeBoyer

My BLA. has you with question and you're do for that had to on OCUXXX, mentioned the track XXXX

for any or trial? you the data details So I was presentations give on could upcoming if milestones wondering

Shankar Musunuri

Robert. allow Since meeting ruling Since it's and BLA as designation designations MAA. BLA are time be of how RMAT on we do will as that do well SSR orphan to rates, the blinded the us study, providing our have line. and -- we'll U.S. our we updates EU, submission in a recruitment

So we're going clinical the take next when that's And year from take done to is the process we'll sections comes the XXXX. to and out, early months duration year. year, a us And that next path the potentially the accelerated will when data the patient, recruitment which starting late X complete X is last will clinical the of then in close that trigger of for trial.

late U.S. allow in will approvals to that So and EU both us potentially get XXXX.

Operator

Gataulin Markets. with question Chardan Our Capital next comes of the line from Daniil

Janani Sundararajan

This is on behalf of Janani Daniil.

And getting tell hold OCUXXX? therapy the the point? away? focusing the hold this Or you you the for you you are us question is in my process lifted, be So launching Can OCUXXX. right at first trial gene the programs for where clinical are once lifted is will on on

Shankar Musunuri

We're mean, the we'll is clinical program. the as path program. as FDA FDA again, primarily -- been with very I still information after the simple direction And on hold, just requested lifting a XXX they forward defend hold designed suggestion to a to lifts clinical working hold, soon get program clinical we focus I FDA that we and will Phase the get for And has good to therapy, a submit lifted. try the gene want reiterate, but study. provide our the the I

Janani Sundararajan

Okay.

have question another on I OCUXXX. So

are So with Phase mobility trials? in to assessments meaningful used the compared the in III achieving there criteria responder LDNA previous differences

Shankar Musunuri

Yes.

based That As qualify will criteria, addressed, the data than clearly we Phase to what patients a study levels the questions achieved I/II. rate response the of we XX% rate. reach showed And product, at stated we treat we XX% response the intend can and earlier, Phase powered they who showed we more. based in who lower today, people approved rate. on II. actually population for And response are we or means Phase analyzed one think it III XX% I means That we and powered from on X our in

Operator

the concludes go call This to Musunuri. I portion. the question-and-answer Shankar CEO turn over will Please back Dr. Co-Founder, ahead. now and Chairman,

Shankar Musunuri

look as the XXXX clinical and today. we forward We Thank you, appreciate joining you. as we continued Thank to groundbreaking forward for operator. with position to Thank second of solidify your continue you, our everyone, us move scientific support as half initiatives. leader. We Ocugen's a biotechnology

Operator

all and call. Ladies you joining. today's gentlemen, that Thank concludes for

may You disconnect. now

Ocugen (OCGN) 8 Aug 242024 Q2 Earnings call transcript