OCGN - Earnings call transcript Q2 2020

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Operator

Good morning and welcome to the Ocugen Conference Call. [Operator Instructions]. I will now turn the conference over to Lisa DeScenza, Vice President of Integrated Communications at the LaVoie Health Science to introduce the Ocugen team.

You may begin.

Lisa DeScenza

Thank you, operator. you conference welcome to like to call. our I'd Chairman Dr. me today CEO, Ocugen's are With and our Sanjay Dr. Musunuri, of Shankar CFO, the and Acting Scientific Chair CMO Advisory Board, Subramanian; and our Mohamed Genead. XXXX press Earlier morning, a and Ocugen a financial this release results. issued business including update QX Ocugen We the review available to www.ocugen.com. listeners press release, at encourage is which the on website Ocugen call the Investor on is be will available days. also This XX of being website the replay approximately recorded and a for Section

our that the our various forward-looking of begin comments, Litigation formal strategy, today the timing position, remind related you to terms Reform raise likelihood our we business operations us, approval, we constitute remarks of on our Before products, statements Safe I'll development make Harbor Private Act research, future prospective to pursuant statements including and product provision costs, ability XXXX, financial of and capital Securities to to results acceptable objectives forward-looking may such to for and and management future future plans success by forecasts continue, actual and results such can These similar cause statements Any and could, guarantees and risks other from to differ words as intend words anticipate, with meaning. operations. our believe, be of materially subject forward-looking not are estimate, performance. expectations identified of uncertainties are statements expect, of contemplate, that and

release over statements on may to Ocugen's XXXX, otherwise. Chairman CEO, new XXth, future account Shankar make call of will events with today's on morning. You the update and the included Dr. this and and filings we only should is on call, provide risks read was any our this as no provided of as Note call SEC. call the this well turn as press that date obligation now we I Musunuri. the information, information described to in or of this uncertainties August factors in our Any filed we forward-looking conference the carefully risk XX-Q undertake

Shankar Musunuri

quarter thank and with global this as you excited of progress everyone I'm very morning, diseases. the the Good Lisa. the therapies about blindness we morning. develop to this cure potential us the for you, transformative Thank despite joining challenges made to have work pandemic we

Our retinitis Phase the clinic, trials next is year. enter in a two track on OCUXXX to for pigmentosa first candidate, product gene it's X-X therapy pronged the

Our dry macular for second and OCUXXX are first biologic, major on therapy gene track retinal product, diseases OCUXXX the enter age-related for degeneration to in novel XXXX. clinic our

to reduce of of the host when to ensure ocular endpoints was interim strategy analysis June, Our diversifying diversification and meet pre-planned And shown was completion. trial in to we portfolio discontinue business decided approaches our Phase A upon risk graft the sample its co-primary indicated X site be prudent. disease. product versus trial for unlikely to OCUXXX

initiated part we therapy novel platform a and of result, our the in a towards focus OCUXXX of and reduction biologics development a as ceased shift As workforce modifier gene program.

clinical trials in term our years. We extend in next were our and for our to through coming into goals early groups and two quarter within where R&D resources to capital our the of of programs midterm of runway further stage We strengthen to in support will XXXX. add first development planned year needed raising clinical ATM short initiating one the successful

quarter our our XXXX Sanjay we our forward. pipeline drive update results to support goals continue will our as patients second on provide Q&A. the and as will an midterm then progress share creation Today, short for highlights we We financial as before raise value capital well to of our will shareholders. product

ophthalmologist, initiatives the of Mohamed drive expert forward. talent management as gene into attracting Chief product Scientific Ocugen an and for cell with Genead therapy and instrumental our ophthalmology offering top retinal tremendous appointment Dr. Our inherited to will therapies. and as dedicated shareholders, advisors chair to support deep as retinal His we're is disease year. Advisory by next specialist, as team in are our Retinal development long-term value our Medical an creating be and Board, Dr. evidenced to Genead experience the and XX clinic also in gene years breakthrough Officer. over therapy platform modifier He's of ophthalmology we gene experience advance our Acting of

modified product. inherited to excited be continue which retinal variety single treat of diseases really has therapy the platform, with We our a about gene to potential a therapy gene

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in conferences U.S. at We Europe in and the and conference October. September will gene investor therapy also in be providing the updates four

to our further in the clinic CanSinoBIO OCUXXX. for with partnership next solidifies development strategic the year Our plans enter of the

are manufacturing trials. planned planned our and Our batch X-X as XXX activities going liter up to well Phase scaling including for size

consistency levels at to commercial applied any scale inconsistency to extremely is product gene of risk this product. future. manufacturing Product of the therapy Our minimizes for the critical time in

are and with very the progress toxicology Overall, we clinic excited on this year planned. program our enabling IND We studies. to with enter track very on next as are happy the GLP into

for diseases, diabetic manufacturing For novel the year a also with meeting of retinal related a OCUXXX, planning and degeneration. this retinopathy, we soon. macular anticipate age FDA secure for later partner this treatment diabetic We're including edema, major to macular pre-NDA biologic

half with agree trials. next macular for a during to For studies treat of dry are meet to year we OCUXXX, related IND planning FDA clinical stage on early age the the to and first enabling degeneration, roadmap

mention Before drive development to pipeline to the commitment want call commitment I deep I continued our turn Sanjay, to product and the shareholders we over as just our of our to our addressing turn the underserved now I rare blindness update. over call Sanjay? and and novel by diseases will provide Sanjay patients biologics. through our to gene XXXX to therapies financial quarter second

Sanjay Subramanian

you, and morning, everyone. Thank good Shankar,

things and develop Ocugen $X.X cash cash provide million before, XX, quarter equivalents, our year. eventful for As financial results We this ended of totaling to to gene diseases. of the million cure overall testing to will time, pursuant a Advaite's the as the Ocugen's second recorded of be runway into revenues quarter respect collaboration develop. COVID-XX year, to development $XX,XXX The update kits. of this market compared of $XX.X the to with mission we of not been this quarter will XXXX. do first the At agreement to now quarter the with blindness we increase strengthens XXXX the quarter year-end well in this Shankar agreement restricted cash mentioned key an and Inc. cash, to second expect we our quarter XXXX. as a has business, extends overview with I very significant Advaite of but on second June for In therapies

million, under months XXX share XX, June expenses XXXX million increase per and due XXXX. driven the $X.X the XX, with research shares increase amendment company difference for the of outstanding. we expenses date, a loss ended the million ended related June $X.X for partially to proceeds Our three million, primarily June $X.XX unsecured and and company three were million for months administrative XXXX We was three ended warrants net million for completed loss to Net the bearing to was severance has pursuant the or was quarter for reimbursement agreement XX.X June were XX, received pre-payments notes XXXX The loss April, three $X.X loss shares compared the $X.X And million. ended severance of compared million by per expense related public months costs of the The the To offset costs. million In months by May $X.XX the June June ended XXXX. non-interest with the $X.X XXXX. XX, million ended Advaite. from $X.X months share for stock notes $X.X $X.X the XX, three months or an collaboration insurance compared ATMs. CDC the XXXX for common ended exchange unsecured and development three June XX, to of the to of in on made and XXXX

any have of exchange reminder, capital pre-merger will outstanding. our a amendment we helped structure the the financing in questions. warrant warrants and the overhang that up not As open the call currently we With for and Operator? address do

Operator

[Operator Keay first question with from comes Nakae Instructions] Our Chardan.

is line Your open. now

Keay Nakae

you. Two questions Yes, thank you. for

you the any do in one, additional during preclinical data year? the publication of of any the First second anticipate half journals

Shankar Musunuri

could data, repeat you additional question, Any Keay? the

Keay Nakae

Yes, data. publication of preclinical any

Shankar Musunuri

On OCUXXX?

Keay Nakae

your or modifier gene Yes, technology. any of

Shankar Musunuri

we're the FDA year, this we're Yes. executing based IND pre-NDA Currently, the Good doing question, studies. on meeting, reached and we with enabling Keay. agreement our

our and We have and of done getting of next studies the first information toxicology tox GLP is the some obviously be any work year. started available interim in will of half the

Keay Nakae

to Okay, get done, work to work? extent tox your pre-IND great. the impacting ability IND tox COVID what And is that

Shankar Musunuri

Keay, repeat the please? very please you not I'm is line clear, your question, could sorry,

Keay Nakae

you now? Can me Sure. hear better

Shankar Musunuri

Yes, better. Yes.

Keay Nakae

complete is COVID-XX the extent to your impacting My to pre-IND tox what work? ability question was

Shankar Musunuri

Actually, so planned. far any are have our of as studies ongoing the and impact COVID-XX don't we

Keay Nakae

the not busy side at manufacturing their on developing and impacting you own all? that's vaccine, CanSino the is fact Okay, that SARS-CoV-X

Shankar Musunuri

on forefront So it's great Yes, busy. they they're very are a the and question, Keay.

trying there's to in commitment our us earlier, They're However, risk to the liter a just strong very scale to which on scale, continuing up as program. side. minimize is to including, my I XXX process and a commercial manufacturing they're and scale excited to CMC us they're any to support support mentioned the

a complete support So and CanSino. from we cooperation have

Operator

Instructions]. [Operator you. Thank

Our Ramakanth Swayampakula from question Wainwright. next with comes

line open. Your is now

Ramakanth Swayampakula

trials? retinitis kind have into questions. gene quick some In these diagnostic identified the from of pigmentosa is regarding these or clinical you A do these mutations percentage routinely patients NRXEX the do you and H.C. your RK on them enroll general, are Wainwright. of patients, a of This mutations before need what couple to

Shankar Musunuri

Yeah, RK. it's a question, good

to thousand the On than U.S. rates, for less Acting call genotyping. all patients ask And about Dr. trials it's have this the and clinical to Genead, CMO we Genead? the in prevalence our who will also address Dr. the again, is the further is, on this. this, do I

Mohamed Genead

right clinical those patients therapy your And do done procedure trained of very need do are standard answer And that. to we in we To our the to gene They with enrollment Shankar. genotypes trials. investigators. trials. is prior site all being question, you, clinical definitely thank definitely Yes, now to to so this that kind are confident in

be process. And this of a so will part the

know the is most prevalence, as the mentioned, disease very is you Shankar retinal is diseases common inherited rare, so retinitis as retinal prevalence slide. the Regarding you as It's pigmentosa saw rare diseases, one this of common [indiscernible] in and our a degeneration.

that apply, NRXEX with the retinal so whole notion the disease the Regarding the phenotypes. you multi this gene one but is is the for retinitis genetic about product diseases. one, and implicated modifiers, which has degenerated different them other clinical This mutation gene oxygen [indiscernible] of there one one that's mutation of pigmentosa, of mutation are is clinical this for only

or For retinitis can pigmentosa. about your RP pigmentosa, of around see autosomal consist dominant that they X% retinitis question X%,

Ramakanth Swayampakula

So available Or to genetic you some to to for that, screening Dr. need protocol? the before your get test validated? Is work test do and much very Genead. thank applying you that the do validated currently

Mohamed Genead

Yes. patient inherited for disease testing with earlier plus this is close now, for to the indications. have even years right XX standard [indiscernible] done or been years systemic retinal for No, testing, our disease

blood to chromosomes at they the and it you samples a lab So you genetic look mutations send the in mutation. on with accordance take and

the for oxygen is done that there's for this been product commercial some before has the and So well data established therapy. in eye

been and before the had all and nothing than separate in So what we're different trials procedure for -- other used genotyping. same the using

Ramakanth Swayampakula

in to development programs X and and going the next next should a four within do be -- up that the what also get for these about these general, programs perfect. know In Shankar, get we want then XX would studies months of to year, the in design half. running think I how planning So Phase so? clinic And the plans you're you or to four general, and over year the

Shankar Musunuri

gene the Yes. Good we are guidance then X-X Dr. deck, FDA therapy planning to programs question, Genead RK. again, to the level, I'll parallel two from The trials. on add. these initiate and based going high Phase briefly And explain as in our be can small. we're outlined agreement,

the because of targeting with exploratory then diseases. You're nine them and about and year with cohorts for OCUXXX, have to to patients patient year, the each safety going talking Phase in one you trial to one And these study, you're three for major one move finalize are along X. monitor the retinal OCUXXX pick endpoints. into And then again,

Phase the more OCUXXX. And do than obviously programs so anything? to patients And want add you Mohamed, will have X-X a lot

Mohamed Genead

the going so the which using Thank with gene little Yeah, platform highlight, more modifier to start the absolutely. in Shankar. A for you, which is we're house, technology first OCUXXX will gene authority trial. also the space. in therapy And especially the health done and be what's the require and already dose a safety, the multi-ascending that with novel product, FDA been was in-human

low, before with loads. be high our will will have we multi-ascending, the at and look OCUXXX at obviously different we And of independent it at data we'll will patients. will of trends those dose least three dose different as be look product, then safety look all mid, well dynamic it concentration So at we as the And escalate. review in efficacy safety, to scores then

human the in at first next two two OCUXXX. start with study We parallel different mutations will by the study we'll look in of year

indication and Shifting The trial mutation. be as lead novel other the the gene novel OCUXXX we the patient in-house, NRXEX it macular the will be therapy, the one diabetic be rhodopsin, That with will first will first which using program to targeting our biologic our retina will be the so OCUXXX. of will first one for mutation is the as be edema indication is a first for a not biologic. RHO

with to start Phase trial. be close will around will We it the X-XA, XX-patient

thickness point our standard on standard look efficacy We will we endpoints the macular main other diabetic look acuity Also, patient population. which safety will the this at has efficacy look going visual at objective. the is at and patients for and to obviously endpoint been be will retina and we with the edema

So will the and then OCUXXX XXXX. major this the idea XXXX, two problem, the be OCUXXX sorry, with would be And early coming the OCUXXX. in the

Operator

comes our Kluska And last Cantor you. with Fitzgerald. question Thank Kristen from

Your line is now open.

Kristen Kluska

and locate doing morning, Maybe you to everybody. patients Luxturna general to the the marketing number in try genetic one what doing trials some all with be the broad Hi, focuses these RP given where Hope from prevalent on questions, of could the increased trial? your what just patients? you're on rates, efforts well. good follow of of a also are up also, given clinical on of for And now testing XXX thoughts RK's pipeline focusing patients very are

Shankar Musunuri

Dr. Genead, ahead. go

Mohamed Genead

for question. Yeah, absolutely. Thank your great question, you

patient are for of to the working the stationary the general planning of see of Europe. retina is you definitely but this not and And kind our we center build So also in as one retina registry clinic now our country excellence so in I'm but patients, plans more know, the U.S. only you specialized. out it's in surgeon, with

So retinal country. excellence generation we in centers have of this for

be and with So have we now collaborator the for these have And partner we also which we country area the database are and finding the working in to volume, find elsewhere patients. these the in with patients. we our trying will

get our clinical groundwork our that in around and potential will our with investigators all clients We trials.

continuing our as that development. on we work we in further so will go And

we're clinical earlier And one said will I in connected which work with even enrollment own with the a we're strategy, and patient each and for patients as the registry and has our group working the disease targeting now development so for key the find those genotyping our strategy to. for their patients. clinical Regarding like sites close other are things Blindness product foundation development that late very these registry. of clinical with strategy, commercial And the foundations Fighting Foundation and we and other that also leads be for

started our areas So one we this and work of And work we'll is continue very that at we're carefully. looking the the space. on

Operator

Ladies answer remarks. you. like our for to call turn Thank and the now and concludes to DeScenza any back would concluding this over session. I Lisa question gentlemen,

Lisa DeScenza

We therapies time market Thanks updates morning. to bringing this dedicated for you. patient to further coming blindness the for taking diseases. the We're Thank join to transformative to by forward the filling months. significant providing everyone in needs call to look

Operator

and Ladies concludes you. today's Thank this gentlemen, conference call.

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

Ocugen (OCGN) 17 Aug 202020 Q2 Earnings call transcript