OCGN - Earnings call transcript Q4 2019

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Operator

Good morning and welcome to the Ocugen Conference 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 this conference is being recorded.

the Relations to and turn President Beck, now Investor of Administration will conference Kelly over Vice I at Ocugen.

begin. may You

Kelly Beck

Thank Dr. Chief Shankar Medical welcome to our CFO, this today I'd Dr. and our Musunuri; our operator. our Subramanian; is CEO, call me morning. Dan you and Chairman Officer, Sanjay conference With you, for like Jorgensen.

press available We press section approximately XX update for in Earlier the business days. encourage to at this call our listeners morning, www.ocugen.com. is replay the website release is recorded we with be release, review Ocugen website also Investors the issued available on Ocugen on and financial results. which will a This of XXXX a being

remarks the constitute terms statements our ability such trials acceptable clinical Reform including related Before capital comments, our the sale any financial Harbor timeframe and we Safe Act begin statements our formal development studies Private to our to make various our of pursuant candidates forward-looking future we Securities preclinical ability with to timing I'll and for to product outlook, of that on provisions the you including Litigation raise XXXX, today to results and asset and the associated close us, such of closing. product our for NeoCart product candidates, the remind plans

guarantees similar can performance. such and plan, estimate, and other that statements actual expect, of meaning. results cause anticipate, forecasts, believe, may identified to such are future not uncertainties from forward-looking intend statements upcoming, and forward-looking materially our risks Any and may, are These expectations to subject by words of will, differ should, as be words

new after call described be information, Risk XXXX call today. provided XX-K, which the we conference only future statements are we of this the provide filed obligation in of undertake Factors otherwise. on is on may update this make day or risks section market March the this no we information call, Any close any account of as will on and XX, in to the forward-looking These events,

over CEO, Chairman and I now Musunuri, turn the call will Shankar? to our Shankar

Shankar Musunuri

Good you for And Kelly. joining you, us morning. morning, Thank this thank everyone.

living are in We unprecedented times.

we most this are our participating, all we working in are remotely. and that is team social at means practicing distancing people, This As call, one Ocugen here for not location.

when So with please section. bear us to get we Q&A

As response. we we coordinate, will

and XXXX activities development results modifier an well host approaches our breakthrough ensure risk portfolio product year Nature OCUXXX of with diseases. share diversification highlights before the eye then disease, our progress Q&A. the as therapy full with ocular the trial suite, reduced in versus patients X on Phase of gene Ocugen’s provide a for Gene and and our update portfolio Today, as financial graft our Sanjay we platform laser-focus on recent will Therapy. publication will clinical business

The entire for and value advisors our been shareholders. team on have long-term management our creating strongly focused

Our most advanced oGVHD OCUXXX or treatment disease graft host versus the of is short. ocular program for for

represents a in allergenic to and to unmet need. is marrow reminder autoimmune critical patient oGVHD. population. from clinical designation oGVHD, also company drug for received and We're first X FDA first we the in this have the trial only to the orphan company are a and conduct Phase is a no a approved that chronic As up transplant for severe there XX% FDA disease medical Presently, of bone treatment occurs patients oGVHD

screening of we new COVID-XX March to completed We well in reached shared XXth, Our due had that are X that and XX% Currently of as to patients I'm trial we planned of our continued through our to have pleased pandemic. share mid-March. December Phase we over enroll planned XX% enrollment, enrollment. not

working sites safety first clinical our to putting trial, address is team to above with our impact all. clinical Our patient closely the

shipped directly up to the be patient's each for risking the in-person medication to rather than patient, monthly of from arranged an pick have site-to-site We medication. supply to visit study

in-person to the visits, In safety we data. to into willing the endpoint able checks not built which are follow continue up or using phone is protocol a addition, may site include and to if interviews collect conduct virtual visits,

in-person For those minimize process follow up they risk sites to the visits, that a the place are in conducting have to patient.

Our has each built protocol windows around in assessment visit.

visit, some is it exact the to in-person. So the is of there as remotely whether or flexibility date done follow up

having we our we this the year. right will before from are the schedule study now, on end situation we its enrollment, ahead monitor to anticipate because The trials. continue is changing, of clinical impact however, of As our and top-line for still of results rapidly

gene would like I Now, therapy to our talk program. about

restore We excited of variety receptor like to the master genes role has are therapy vital the normal a the modifier with in nuclear a a many play potential in as within call believed to them, product. therapy gene to our that to retina inherited treat and we are hormone genes function about Modifier are are retina. functions or gene very platform, diseases able genes, single retinal which regulating

we opposed product What master approach potential OCUXXX modifier the was or our may to this gene, that one to current the preclinical candidate The cells AAV models hormone OCUXXX data for of first receptor one or of nuclear underwent month. RP to with treating gene NRXEX treat of product. consists injection. publication of pigmentosa published genetic unique means or with retina multiple have the a sub-retinal that one a The mouse this in results earlier vector. of disease efficacy is Therapy therapy target NRXEX defect details administration functional diseases by delivered using in copy Gene five retinitis in as Nature gene a an

forms demonstrated gene intermediate different PDEXB early Enhanced broad-spectrum therapy associated in and of the RP of rhodopsin Congenital tested Leber study therapeutic novel elicit of forms Amaurosis; RP: stages five RP; associated of represented benefits modifier to Syndrome. five and potency RP; S-cone The The models RP. two the

strategies gene gene with RP RP therapy of potential affect diagnosed, XXX the genetically need eliminate as only be patients over and and that individual has people biggest population. of it advantages eye been it treatment. diseases. the editing gene revolutionarize modifier for platform number such RP degenerations to the for therapy One have may gene cannot treatment Inherited retinal XX% the RP and of associated our is this worldwide difficult mutations remaining represents The making to individual of X.X million or XX% develop gene replacement

need one We patients. gene potential products provide RP therapy modifier option our believe individual all has the to eliminate the than and developing for XXX more treatment for

including Ocugen September strategic As flexibility of and capital manufacturing its is with in CanSinoBIO into XXXX, to team greater CMC all with are entered work. development is share for pleased supplies back all the for located China we and resources. responsible the a is in associated partnership reminder, CanSinoBIO CanSinoBIO of development OCUXXX. of provides there costs. This a at clinical we partnership that

this evaluate do continue and impacts While don't we any the global any have timeline, overall future. anticipate potential to the impact we pandemic in immediate to may our

for We patients continue XXXX. for the to clinical commencement plan OCUXXX of in X/Xa Phase in trial a

patients turn ophthalmic may long-term. both adequate the to treatment about By our the share over want addressing and call it before underserved and diseases, shareholders Sanjay, the our value to to just I potential proposition to short in with how the options. pipeline bring and Now, bring I hope of rare we excited I’m

on I XXXX our an development will over to Sanjay? call financials now Sanjay activities. and turn the to update business provide

Sanjay Subramanian

I now Hope everyone. morning, pandemic. good and results Shankar, will financial during this an key year. overview everyone is you, safe for staying provide the Thank of

XX, XXXX We million XXXX. year compared million XX, cash on cash December $X.X ended and the restricted December equivalent on to with cash, $X.X totaling

decrease for expenses development program. and XXXX. lower The XXXX $X.X the $XX.X expenses research Our to million by were year related in the primarily XXXX was driven compared million to in ended OCUXXX

million The in to was fees partially by difference expenses administrative million the XXXX. an consulting and were for $X.X public in ended and General offset insurance by XXXX increase employee year lower company driven expense, compared costs. $X.X

million ended value offset year in interest the fourth outstanding, $XX.X we the driven warrants of was year. in derivative XXXX total. increase a by of in liabilities and in for with increase ended well shares by loss In year to under all approximately decrease We repurchased XXXX, December, Series X,XXX and the November the the exercised the and B quarter but net in as as C million operating compared XXX,XXX change a last Series primarily decrease expense, $XX.X each million warrants was XX.X expenses. the were an in in the shares The

Next, Histogenics. I'd the to provide like NeoCart from on update we an asset acquired that

have the NeoCart to discussions strong leadership Medavate. continuing are to asset. We and in changes made reiterated some have their interest with their They’ve

in asset. are preliminary in discussions other with the interest expressed have engaging also who parties We

sufficient year. into million currently an closed we EB-X June to We week, agreement. This this additional cash loan loan under have fund our operations the of $X.X

certain including capital We and will evaluating currently non-dilutive our options, additional raise are funding. need financing to

transaction. will We our any progress the we market update close once with additional

partnerships portfolio to or in also to We that collaborations continue our Ocugen and related shareholders. the explore assets can value to provide our

that, the With will call we open for questions. up Operator?

Operator

[Operator you. Thank Instructions].

first Swayampakula comes question Our Ramakanth. from

is line Your open.

Swayampakula Ramakanth

of in expected you. in R.K. also, in time from impact And from questions Obviously, the what Thank needed protocol and some to of three my for to population, X% nice trying needed the schedule, it's it’s by a your of Shankar, hear board? meetings couple additional once of year provide trial? be worst OCUXXX are times patient follow the as how delay Could the amount in is Glad to deadline stating. Shankar of Wainwright. the enrolling a publication was much on H.C. terms unprecedented these the is ahead the you case voices. get end. that crazy see comes month allowing quick an the This final A would to of study end. that let's of the from And color the say -- the data for on enrollment up your of there the as is

Shankar Musunuri

please thank Yes, answer I go Dan R.K. let Dan, ahead. question. you, the will

Dan Jorgensen

for you Thank monthly the study Yes. visits. has Yes, the question.

Shankar day month, enrolled -- return each they gives we for months are mentioned to some once the are do patient collected. been we have when receive visit day they during that this can visit. coming has us due around the day come XX It But or a their every everything That get patient and last There endpoint feel do return primary to visit and a doing XX, a as We're we So up back. is they XX data data back coronavirus. that, the in for that point ensure slowdown safety time. time windows. day and visit therefore the to There’s they in that little is flexibility patients until three checks endpoint the XX around a visit.

delay do end second we and for of the terms in had it getting of what your about by to Now the with year. do question the timelines data the can our

with the are can pandemic, because come patients. we if such a in all believe caught going else has to good those us schedule to pretty of a we to stay mentioned, doing lifted, number. all on and in on necessary that their having to for of we that ahead Shankar slowdown be enrollment into quickly, be it shape. do everything monitoring we can't As that would -- the or shape puts time patients the the when on the patients to real have we ready We're are good monitoring still in visits, the planned up in, happen once is all you restart, I of while patient If that restart if will, we the close very takes do and enrollment additional

Swayampakula Ramakanth

of the Thanks, up finally so the because if outside on itself Dan, analysis just out you during with doesn't you of don't if up to this associated stated. the COVID-XX can dropping But period, quick statistics you, to what I people for it comes on when have anything dropout this just know of been anything question. screw answer the inconvenience for are rate that. else you treatment A see or that it monitoring data? follow

Dan Jorgensen

Good question.

and good, terms quality the less of a X%, all, in the and of So dropout of very to the into it's of was which low, very data. sites was retention, and very in clinical basically, than patient terms going testament encouraging, rate first team pandemic, the

to Now having the extra study. close mid-March for once and for course, those that's in the for are screening we the who most sites, But pandemic now and of of are started, enrollment already that's visits they started those basically down example. around when

The period. So two enrollment been great week one mean get six staggered, not it's peak, far, in we patients question. to over I so fortunately, or maybe has been the had seven at to its one your impact to -- has enrolled a --

of us you date flexibility enrollment days That's So there's each up the follow every screening count from one patient or to and you week allows for for of That focused put around due those of be in that's two that to can follow see XX one visit. terms subjects, window out those visits. and that a the each important. on up a

So of getting now and are right at mentioned, we means as supply. But those their endpoint patient obtain the sure data. in day putting in make data as to place XX drug policies far, risk also patients only we two that terms are speak remotely. we Shankar And has processes

following and So, at has each every But site. and it impact right we're and the on basis a each minimal we're so now so daily good. following subject been and every far,

Swayampakula Ramakanth

for One question much last Shankar. color. that Thank me, from you very

You collaboration have a big CanSinoBIO. with on going

have over they CanSinoBIO last involved the in I they and China stated in get of couple development. would company -- a is CanSinoBIO COVID-XX that weeks think stated As the drug

strained So program? work do the any way need their resources gene that your in modifier to has do to they that for

Shankar Musunuri

weeks And Good been mean constant their communications their COVID-XX on very They're question, addition last in are on. impact and with working them R.K. vaccine. And completely they as -- the work important that closely few I to work workforce very, in and our workforce right. and mostly goes no we'll that, currently to you're program And [primarily]. think time situation We’ve to I absolutely back. is OCUXXX in on is back is the the monitor continuing there to

Operator

comes Nakae Chardan. question of Keay the with next line our And you. Thank from

open. now Your line is

Keay Nakae

a enrollment for had of nice GVHD. pace you Shankar,

mid-March going back what implemented up October, discuss what that, meeting practices. and the had pace with about Just obviously the in I you resulted a investigators helped things. like seems best summit GVHD the in you back of know enrollment talk was this to until to It that's nice period? Can

Shankar Musunuri

I’ll the that. you, Medical line, on Officer, our go Keay. him Chief let Since please Thank Dan, answer Dan, is ahead.

Dan Jorgensen

And enrollment study this Back Sure. the in That's very encouraged terms were to And study would enroll that time. closely again they we fall and very challenges a ever of single the every we're of a by in in question. course, very good nobody like the also that since before. evaluating the done their ability what have. or has study obstacles patients into site

own then So unique sites. that were had cut some and challenges all everyone to it challenges was turns it and obstacles. site And obstacles the new out each there its and across

Of rare disease is with. course, to a this begin

had be or There's patients ICD-X identified. to XX coding. those So no

we of And investigators a had had oncologists study. we the ophthalmologists between and and the own for find the you patients forge that from that are So at those means hot could academic type to strong that very the principal who as them. center institutions. transplant of those any out, not clinic, of the the of each each patients, use doing marrow turns to And the come closely mapping relationship or site with worked bone database oncology have sort to it its very one way is

sites We very sites time way us are terms that or enrollment and those were even the the a to quickly. caught of finding radar. the having really with that ones then other on getting so month in also And patients last issues found helped more in spend the

Keay Nakae

the assessment and And will, quality, these talk of follow how up, of great. if you doing remotely, about of the the then Okay, symptoms? if in you terms maintain you're sign

Dan Jorgensen

extremely So as important. far obviously maintain quality, it's as

of pandemic. and are have into based So on with And the all FDA's fortunately going had we that recommendation, had be on with are board for up we have training monitors on done and monitoring the course of of requisite to switching now kept a monitoring everything, team our that, all type the remote are of monitors monitoring. with sites board doing that the monitors of and over the that to and

of the So of in we're the the quality monitoring. maintaining program terms

of that In until collected at addition, lifted, example, we person visits ban again. that is points see the are can important patients time the we'll data, in virtual have do we making example, the end are for all will, you sure and to the the data if safety for these

by that make are are quality. visits that call, those highest the be of a one more that sure perhaps that call, patients the we need are So will telephone virtual to just data and data collected, telephone fine, than accompanied the doing

Keay Nakae

Okay. lot Nature then Therapy And a animal paper, of terms the Gene work switching to Shankar, interesting and what's good model really next that evaluations? additional paper. in in of

Shankar Musunuri

Good Keay. question,

five and is CanSinoBIO we going up planning X/Xa being the toxicology agreed studies, animal side, what indicated that. models year, are in do trying initiated. I four U.S, into think, that in year Phase this we -- the studies studies then, while those is already as clinical animal And covered to we are And with planning initiated we manufacturing working preclinical we on planned, the we as we finish the what have what are and is to in next on do actually are our to FDA initiate trial. toxicology paper,

that right. is manufacturing getting filing. and now the supply. Those studies done; has then into So are IND the request components to need clinical go up that for finishing two One components, two the tox key

Q - Keay Nakae

tox do with studies, that terms impacting in doing ability of to work? working how is labs, And the their the COVID-XX

Shankar Musunuri

at around Keay. is the just our in everywhere anything like the just people situation question, us. with the Pennsylvania, our again and working a top like closely us else, employees’ in monitoring time, Again, we're And in some mode same do shutdown have we’re great priority. Yes, safety are U.S, now we And buffer.

labs the narrow a schedule. Some working very, of are very on

These major two, company it we or very any the continue We in very phenomenal with us. we But thing about supporting should next therapy doing is, to we're in as CanSinoBIO. a not on job gene program. times. vaccine and monitor are honored R.K.’s back they And And really will are and these know difficult really times. I are there's hopefully to good to COVID-XX improves pharmaceutical guys work like difficult a they're passionate have working just a mentioned as month hope. real question, in impact. the So other they're And situation

on. posted. monitor work for keep will for again, our guys and will we we So you plans manufacturing OCUXXX closely is there going clinical And

Operator

for back Thank the you. at further questions like [Operator to time, Kelly to And Beck showing not I call would further any Instructions]. now remarks. I'm this turn any

Kelly Beck

Thank call join taking the you, everyone the this for operator. time morning. to to Thanks

fulfilling need We patient to updates a eye further or diseases. coming are market significant great in therapies day. dedicated bringing by We the forward transformative rare and for providing have underserved you Thank to look months.

Operator

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

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

Ocugen (OCGN) 27 Mar 202019 Q4 Earnings call transcript