- Earnings call transcript Q3 2022

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Operator

Good morning and welcome to the Ocugen Third Quarter 2022 Business Update and Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the presentation. [Operator instructions] Please note that this call is being recorded. I will now turn the call over to Tiffany Hamilton, Ocugen’s Head of Corporate Communications.

Tiffany Hamilton

Angela. you, Thank

to financial more Finance, for are morning, Shankar today and activity and we and periodic factors Factors with President Earlier fully CEO the cause Chief Joining Commission, provide annual other our who Ocugen’s release, that quarterly filings and and on than We from XXXX. encourage management. will press other entitled the Dr. current will our XXXX, file within ocugen.com. and in of Vice Exchange our meaning as plans, replay Senior Musunuri, the and days. subject the Securities that numerous review some results. forward-looking Officer detailing use which may, the available or website Such at important section be in believe, a slide identify press such release to expect, in actual this risks future on update will, Crespo, This SEC, provide website All the contained our on continue, historical statements. Ocugen events Co-Founder, business proposed, the QX recorded call or described of who the may estimate, Accounting outcomes Securities XX contains me are materially this and differ potential, most on statements cases are terms and beliefs issued expectations. and along are Chairman statements Jessica presentation other uncertainties in predict, might, presentation listeners a events presentation we to with our risks including assumptions is and factors, is and to a This Inc. currently convey results the Investors We reports available are accompanying information which and of may the the should, on SEC. anticipate, approximately intend, could, facts available to uncertainties words being section based forward-looking of or of statements. with the Act of uncertainty risk These the of Ocugen these statements Private statements for and Litigation described Reform will Risk business forward-looking

Forward-looking of this that required of as as by presentation in we the new of this forward-looking make no update after presentation, statements events this assume otherwise a as obligation this we of whether date presentation. result or Except contained information, speak the in to law, statements date presentation. only future

third soon the I Finally, will XX-Q filed Musunuri. Ocugen’s quarter be after Dr. turn to call. will today’s call now

Shankar Musunuri

shared in COVID-XX. The modified about patient-centric as and we company. in the to charge fully Ophthalmology team Conference detail R&D therapy also more to potential the for Ocugen enthusiastic OCUXXX ahead establish continues of vaccine week. platform last of biotech driving our mucosal you integrated a accomplishments and and and important gene Thank therapies a Tiffany. as development thank we quarter proud I'm of with everything force now our very progressing which third pursuing our program, do, we for and courageous expansion behind vaccine Good you, we're diligently renovation unique ourselves first at gene Academy Day of achieved We're includes American that our our very call. broader morning Chicago the in with the joining cell a

cell effective like remains our therapy program. therapeutic no with fight is I'm the signed the more persistent, vaccine patients critically and vaccines, who programs. confident especially to I As ground gene we break and team going people would again in well-poised COVID-XX have new world in provide and effective that our and we option. want who Ocugen's to new needs regulatory milestones, on Today, are meet start COVID-XX. to options and updates choice clinical and for vaccines drive safe directions the

in until what in been currently reducing We think hospitalization what to face the limitations vaccines of much United the rate, force much to but more the attention reduce challenges need will the broadly we variants States Up now, and transmission. of COVID-XX terms bring. on new are of threats and phase next of this unique some that has consider realizing required is will and available of capability their to durability

rapid with with As generate September, the lungs, United and the mucosal mouth, Washington pathway the and to that vaccine has enters our clinical help regardless the mucosal pandemic by represents transmission We SARS-CoV-X to vaccination. and agencies in with generating its commercialize IgA immunity a nose, proprietary Europe. This to cell believe manufacture IgG, booster, government upper tasked alluded the University I develop, the We in can announced we body. OCUXXX T regulatory and potential to neutralizing in States, on with agreement the and rate universal where the of earlier, US closely COVID-XX intend initiation local licensing mucosal preparedness and trials. infect vaccine responses. approach Japan airways reduce of previous work potential

completed in the for Additionally, the Phase more and of and immuno-bridging dosing broadening with top a XXXX. addressing public's development durable early continued trial immune our candidate expected COVAXIN. we data with vaccine, COVID-XX Enrollment X/X continues line need response are to clinical was in

have encouraged are identified no the to trial safety concerns that been We in date.

of Jubilant transfer, patch the at we completed HollisterStier. demonstration As successfully a technology part

partner once Health our resolved. We move will to with ability the World concerns forward Organization have been have

on therapy populations. patient along inherited to gene larger blindness other to moving our Ocugen affecting diseases focused on diseases is program. technology, deeply with committed Now our retinal core

recommended progression, disease tragic Cohort Retinitis independent to cure, the limited safety a for Cohort trial The and no which progress proceeding our OCUXXX safety data a subjects clinical board to completed enrolled Pigmentosa blindness. to the in in and X medicines block of in and to X/X subjects Retinitis data review vital work monitoring enroll for there Pigmentosa, We Phase help disease for for X. is journey are leads manage treatments ultimately in no that making patient's

the patients mutations We the By and more the efficacy patients enrolling year. LCA Currently, Leber Amaurosis, X have and expects RP initiating from million company Dry nuclear associated with RORA of patient the for dosed than also of And genes, end -- or X/X to platform, end analyzed Stargardt Congenital collected utilize therapy XX AMD, The macular LCA to Phase are million associated dry in we will dosed the first of a disease approximately receptor X orphan affecting data degeneration Dry two the addition mutations. XXX the the is Americans study complete be the start before is Cohort OCUXXX, with study, which an disease, trial. of RP AMD. enrollment and will globally. alone. current people LCA disease mutations quarter, to treat Phase with with or our rare is hormone modifier will age-related potentially gene, more announcing treatment leveraging OCUXXXST gene that be developed XX affects by to the genes. eye along X than approximately investigated in being this

QX, clinical currently trials We Ocugen in are to of Phase IND in trials applications X/X both conducting for clinical to programs support file study. have XXXX. completed these manufacturing planning successfully IND-enabling initiate CGMP is and

DME. diabetic health the retinal AMD. currently on designed diabetic IND studies space in threatening macular a to fusion such X trial quarter of Phase is targeting edema, and planning is and to modality executing Ocugen as retinopathy XXXX application OCUXXX disease product the diseases novel is based submit a Another in Wet to an IND-enabling protein. initiate is first

or a adults. designation, development shows cell X therapies, regenerative working limiting the in the FDA building the NeoCart. and in regenerative suite FDA NeoCart Regarding cartilage protocol complete the its our to therapy, expanded Phase reduce in Earlier year, May, of therapy for own pipeline healing its to and for Ocugen our with to manufacturing full-thickness study. medicine into to progression lesions the advanced repair the osteoarthritis. this damaged to pain, cartilage rebuilding prepare NeoCart potential cell accelerate orthopedics of of knee advance knee is with we the is and RMAT granted

in long-term and benefit and is the now results. I’ll to to of turn in pipeline. patients advanced call financial the our the relentless XXXX from clinical potentially our can development who Our ambitious culture our clinical Jess goals innovation, agenda we're diverse quarter reaching our our rigor towards of courageous provide reflective third pipeline pursuit our

Jessica Crespo

Shankar, third and good the of now morning, you, everyone. of quarter provide Thank the an overview for I'll financial results XXXX. key

third quarter to in were and primarily research for Our expenses cost months ended XXXX. our XXXX. administrative three compared and months for to research $XX.X XXXX, September million September incurred three compared the million trial. the three $X.X development million the for executing September clinical months XX, expenses is driven XX, General increase and The $X.X development XXXX, to $X.X million, ended were by ended XX, of the for

net net or net loss per the quarter a $XX.X of of $XX.X share approximately loss third quarter million Our loss XXXX. to was of share XXXX, loss per net compared the $X.XX third $X.XX or approximately for million for

cash XXXX, of compared XXXX. million cash as XX, cash, as restricted to equivalents and September Our million $XXX.X totaled $XX.X year-end of XX, December

of are managing prioritizing on the use We capital. our and focused efficiently

Tiffany, my government the to work cash to of agencies you. into of vaccine back has the concludes us fourth and program runway our the That the quarter COVID-XX plans US for our with Our to support for extend funding allowed quarter. XXXX. update

Tiffany Hamilton

the call Angela? open for questions. Jess. with Thanks, that, And we'll

Operator

Instructions] first from line Fitzgerald. Your of [Operator question the Jennifer Cantor Kim comes with

Your line is open.

Jennifer Kim

taking thanks here. the Congrats have quarter and everyone. I for questions. Hey, our on few a

that incurred reflects The mentioned I first think cost is, the the cost you for trials. clinical R&D

us OpEx the the your would terms building for to walk line Phase that where that safety what you overall we My said think an expansion. second I'm time for just for And potential R&D So for question et steps adult conducting the you I know about is those line like cetera? G&A steps in and results discussions numbers of the the with should those trial, for in at terms for are Covaxin. wondering through and sites how top manufacturing going look the Can and prepare II/III agencies just you're next forward and quarter. NeoCart of

Shankar Musunuri

Jennifer, I'll answer morning, the thank first Jess Yes, question. good you. let

Jessica Crespo

Hi, Jennifer. Sure.

Shankar Musunuri

second the one do I'll

Jessica Crespo

Yes.

a So with regards forward to the basis. cost on go

proxy expenses at looking R&D I probably go decent is forward our G&A. and a think for this quarter

Shankar Musunuri

question you And is related -- your your second to second NeoCart question could again? internal repeat

Jennifer Kim

sure. yes, Yes,

Covaxin, the sort look II,III in through would that walk should your time the data next? top what III, discussions line us data for line Phase you like the of steps after can terms the where of For next for and you go and

Shankar Musunuri

yes. Yes,

data year. So stated, and the second And the then after completed all dose. patients, going we will dosing after next addition analysis to we completed. bolster we patients enrollment, it's also get are because the give Obviously, release in to and with therefore, mentioned naive mRNA pandemic data will at vaccine. had the mRNA the mRNA we're the XXX% data taken done line means who study are we the And we also before, and we’re have currently And patients some line patients patients That as the patients, direction net the get as collecting our going top do with from data, we results although stage samples difficult have enroll who really this to on top case. early data, before. to anticipating to took

on light And of lot on based once on for which a people a US we the can US BLA. we good for Covaxin protocol, for forward which based FDA believe booster is shed be so with who data, safety working But only however, believe that, immune we already will a how the with next a may shot, Booster demographic we're on in based response study needed mRNA spike. broad again, because into make the move that took

Jennifer Kim

Okay. helpful. question. squeeze if one And could That's I more very

And As III OCUXXX Cohort in would expanding trial, LCA LCA needed patients to you then the you dose? include many then how at patients, support then into be moving expand are your X Phase to

Shankar Musunuri

Yes. a No, good that's question.

So yes, that's the you plan stated. just like

will the dose they be three FDA most goal tolerable with to Our patients and go is recruiting with

Jennifer Kim

All right. guys. Thanks

Jessica Crespo

you. Thank

Shankar Musunuri

you. Thank

Operator

Your next line LeBoyer Capital. the Robert of question with comes from Noble

open. is line Your

Robert LeBoyer

there question to the as a give frames are starting can clinical had and I on us that you trial? the NeoCart morning. X protocol Good any if time or Phase finalizing

Shankar Musunuri

it. some to to FDA. Currently, our Yes. steps finalized protocol with time. been is working with still Robert, two them getting we're -- are take there We've One

limiting important think most I that months. is know a in the that I rate few actually cell personalized we medicine. get we'll step, manufacturing The second because off almost next is therapy squared think most like -- The our step,

manage facilities, we need can need don't you highly with You very science, where facilities. complex manufacturing large scientific, but do control. good small It's

our build those to Ocugen facilities We're has why that's So, preparing expansion. own actually in committed our R&D facilities.

FDA step end most year. rate this. for the agreement; getting getting second that's will we those And facilities be important limiting. anticipating So, of ready facilities is are ready our next the the is protocol by One

Robert LeBoyer

Okay, great. That’s very helpful. Thank you.

Operator

from comes the Chardan. Daniil Gataulin question next of with Your line

Your is line open.

Shankar Musunuri

morning. Good

Daniil Gataulin

you Thank taking morning. Good for question. the

couple here. a Just

is vaccines see Are with So, in for of what them. just two for being them is your looking to wanted what complementary? you both pipeline, a the at together? OCUXXX, strategy COVAXIN them I picture and working big as the

Shankar Musunuri

Yes, absolutely.

really obviously, OCUXXX, So what needed [indiscernible]. you vaccine mucosal respect is in vaccinate of

can So I Otherwise, to entry field experts virus the that something you mean, need the stop virus. -- All of believe I will control you mean, will mutate. really have right? to continue that's mucosal important. we in really where the transmission, vaccine, the

and I our response. if COVAXIN long-term. the response. So, I a going broad mean, COVAXIN broad that's offers ideally, think for a gets good immune establishing everyone immune be to And

So, immunity. you have adaptive

ability So, vector or you adenoviral a then very to emerging variants will vaccine to also fight And It's even it's this the make platform. which based inhaled on take which convenient kids off is as easier in you'll long-term. And vaccine. potentially. be mucosal intranasal, have booster for

vaccine. on new produce to basis, viral as easy an it's come this vaccine our to the variants So, compared in annual inoculated

that's So, the virus whole vaccine.

So, distinct feature. that’s the

So, vaccine where right the need mucosal -- really is great obviously, mean going. needed a is now pandemic this it's I

Daniil Gataulin

of still paying OCUXXX, mid-XXXX? That key should to? initial helpful. be attention are it. Got the particular we another Okay. to are was that if metrics by one report so, And what on some you And data guiding the

Shankar Musunuri

I we'll our clinical X/X And to the safety. we data give rich mean goal is by the to endpoint some mid-next the before, primary as Yes. monitor and data is year. continue mentioned Phase trial,

monitoring observational endpoints. based endpoint And are Phase have X. we going efficacy different However, mutation each into on may a

of endpoints, looking the degeneration? any as retina. of signal structural reason you'll these is multiple right? under Stabilizing a degeneration. that's in means broadly looking You're observation a protecting endpoints the are and well So at Is structural structure there functional there be OCU, at as the important really from stabilization patients,

And so functional and you're looking at aspects aspects. structural

a Looking mobility hoping -- data be looking next at to at and mid release of perimetry like those we're by will or some year. are

Daniil Gataulin

it. Got Thank you much. very

Operator

line the with Capital from comes question next of Aschoff Jonathan Your Partners. ROTH

Your open. is line

Jonathan Aschoff

Thanks To to I'm morning. to mucosal neutralize extent that one effective? vaccination do guys, sorry, might extent is COVAXIN. or you actually, question and XXX make it's on on OCUXXX. what's that prior good getting My To them adenovirus on what what it think that allow status and not really

Shankar Musunuri

Jonathan. morning, Good

your really I vaccines, of think if is with primed primed, -- when you are mucosal mRNA. it's important typically, with give most system Americans

have primed So help. shots mucosal if vaccine two they does

before important vaccine. who least That's our people primed are data get really out. as full the our is before, benefit. is So vaccinated the to have potential That's pointing mean, a where to universal At booster target. vaccine. And it's really goal they we I mucosal get target the

Jonathan Aschoff

you. Thank Okay.

Operator

Mizuho with of line question Ear next the Uy from Securities. Your comes

line is Your open.

Uy Ear

my Hi, guys. Thanks question. for taking

government the to curious I vaccination pay. with from commercial Just guess, essentially, moving pay -- with

the you about how I Thanks. guess, are COVAXIN, wondering guys for role Just OCUXXX? both ultimately, thinking

Shankar Musunuri

Yes.

So some I have announced it into to players or some seen price $XXX the pricing, competitors our a think dose. anticipating them of have market. They're of you it vaccine private move will want

primary COVAXIN as as the site wants be the good booster. a well cities, it a very somebody primary which to so take However, would a path follows as traditional vaccine

significant like a there including the the worried is the up, and if great the lot way I governmental Therefore, something there the mutations and and that in a way you control really need mucosal they're field, all don't However, or vaccine from working launched it. they with control They're the We the transmission. believe is mucosal democracies, vaccine, there, supporting we're largest government coming out from are agencies. something because mean to countries agencies transmission for it. emphasis experts behind novel with it, China, we India of the to about

should think our where believe in least become is transmission, vaccine. support. for the that, what But OCUXXX. believe will and everyone development they support, that of future years. mucosal to elections I in And short government term, agrees, vaccine control should really government step we're government it's at we that time, like eventually, may to we mucosal up something which support And private believe. we the hoping, have for the That's

Uy Ear

broadly is And just about Thanks. your China the it's in and authorized whether following up on in and a you how effective comments country India, OCUXXX that could being us of sense used? give those

Shankar Musunuri

and Yes. In the they published it, the data only looks III is China, also or obviously, and neutralizes concern it's which They India, mean existing. India, variance inhalation mean, in not to good Phase it good just I head-to-head, data widely I today, of the out is other which coming of clinical mucosal public. they showed Both out. myogenic COVAXIN is in the some IgGs, our variants have companies stated a trials. our of compared rolled emerging also launched response. data vaccine, the from vaccine And

some there's out last of rolled fact, many cities large there out In many, it week, as public they in for China. information

we least looks So, is, the at there publicly don't data how -- know good. but data available

may are be So, and mucosal both this They them transmission. very of control pandemic beneficial. out pointing vaccine

Operator

back Musunuri. Q&A this There over Chairman, This at the and concludes further to turn will no time. Dr. now portion. Co-Founder; questions the CEO are I call Shankar

Shankar Musunuri

I'd parting with Angela. to like additional thoughts. you, call conclude the some Thank

and next We during that creating out unmet that day We have a company and between week remarkable by targets R&D medical the this shareholders patients to progress integrated vision have we potential XXXX last as shown significant XXXX, five fully the launches believe our years, impact R&D filing bring health. mean targeting to need discussed at pointed our BLA to patient-centric achieve innovation. We biotechnology of Day. product therapies our we're and of public value our credits reflecting each gene and in what

gene partnerships the and offer of continue our areas seeking for the Ocugen We in start leaders pipeline the government the strengthen across patients rates you to outside In vaccines on agencies therapies, have our to with to partnership for to will gene next year us on the today. allow support short prioritize joining to our disease we resources public to getting term. will we represent hope to Once become health potentially continue long for it data term, in growth. while therapies, Thank globe. support form we US

Jessica Crespo

a day. everyone, great have And

Operator

today's concludes This call.

may disconnect. now You

Ocugen (OCGN) 8 Nov 222022 Q3 Earnings call transcript