OCGN - Earnings call transcript Q3 2018

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Operator

Good morning, and welcome to Histogenics Third Quarter 2018 Financial and Operating Results Conference Call. At this time all participants are in a listen-only mode. Later we will conduct the question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, today’s conference is being recorded. I would now like to introduce your host for today’s call Mr. Histogenics. of CFO Lieber, Jon Please go ahead.

Jon Lieber

good Thank everyone. you and morning,

and call Gridley, our issued Officer. our me Medical Business today operating and A was Adam for the on Officer; Chief Histogenics' our Haut, Joining press President release Chief financial XXXX is CEO; the Lynne third Kelley, this Kennedy, of announcing morning. Stephen our Officer; and Operating Chief results Don quarter

the share find Investor who you not seen it have will at posted question-and-answer by will On and morning, in a be of For call those of a which update session. www.histogenics.com. section it, yet financial website with our this you results, business followed our our we you will

The data the refined securities candidates, are operations forward-looking laws. based any results federal you our for data; our statements of call control NeoCart’s other position, discussions approval compete; our Before expenses meaning potential on and BLA market to operations during Phase in continuing this regarding that products; or a future approved timing, associated expectations with make the submission clinical and NeoCart and we financial success the and of statements our to markets we for and a or various and the considered NeoCart. the our for remarks, analysis objectives begin business cartilage the NeoCart we of of and results our about and prepared product future labeling timing knee regulatory I maintain within the strategy, the plans and would as regarding for potential any size where potential obtain population of ongoing the damage; to FDA of quality remind trial, like patient partners updated of review ability clinical III treatment expect

filings our make SEC and website. be minutes on by expectations disclosed described our held held We received yet upon call on no information not call is today account and this previously or changes fully information, from in that encourage subsequent official the statements official the on of involve These SEC to meeting or meetings are in in C may October our provide on that and and as We provided supplemented meeting on forward-looking the this discussed undertake the or filings. with the we All events altered on EDGAR the more Type update we and meeting and SEC's assumptions, the conference to on statements the any current read be new future information uncertainties. are forward-looking system risk, this investors obligation are XX, of call based available XXXX may Our circumstances, information we all only FDA. any contained minutes otherwise. FDA

please Finally, I and to recorded being be Adam. is webcast. over advised the turn will call call that today's now

Adam Gridley

Thank results trial. quarter, you, joining morning. NeoCart our everyone the top-line third this to In the the Phase III for and we call from Joh, thanks announced clinical

the discuss with that to NeoCart all on FDA from submission trial the on continued data FDA based potential of the we've the BLA. with dialogue clinical active met License we and announcement, potential an parts Biologic this Following Application the

improvement FDA statistical at statistical provides well the than very using months, data the the and We and continue meaningful sustained current safe two and year III clinically a microfracture to called standards. for both superiority believe from demonstrating performed years. over six NeoCart one Phase trial and demonstrates NeoCart early the plan improvements better

feedback. closely NeoCart with We surgeon, have the continuing clinical potential aligns confidence in and benefits patient the data

program, an such the on as as two of for equally note activities to the will visibility compromising we've the FDA. we’ll interactions provide summary the the the provide primary other and the over aspects the announcement important This agency endpoint. pathways that we the regarding address the the from without missed the remain III a clinical NeoCart of financing BLA trial pragmatic active Please we've provide We’ll conversations a our its seek with steps. Phase the had we next continued and since much update brief our data. product with investors However, received as that top-line on and status the well interactions months questions last with morning just also of regulatory of trial

the analysis III presented primary FDA as the Phase patients, analysis endpoint in Intent just Xth population, recap a one responder NeoCart well-controlled or So clinical missing the statistical two our C XXXX those let's trial briefing under company to the statistical in prior the and brief conducted as XX% The investors hurdle responder as microfracture We the formal with Treat, mITT as for meeting. FDA at significance were was history we to microfracture year XX% patients and start of with modified that the the Type responders. products arm evaluation XXX covers well United with data and September versus trial primary of a today. of randomized as package in or in developed significance trial one chose responders control NeoCart in patient the The approved is input. to versus in microfracture endpoint development higher XXXX narrowly endpoint. which States to much on guidance FDA's primary the XXXX, and first In by missed presented the recent

patients. XX% at six our XX% versus of significant of However, NeoCart statistically patients were microfracture responders months

responder such lesions at the On We treated to analyses in function and greater and and XX threshold patients to in FDA square centimeters, efficacy defined data on and broader other both prospectively analyses the demonstrated improvements and than conduct results represent KOOS surgeons. These in responder in utilized meaningful meaningful we statistically which believe also underlying The covariate NeoCart IKDC IKDC pain by standards, as populations baseline other be greater those and patients. collected the were outcome patient then improvements of with dual a and demonstrated X.X used and in BMI versus variety as superiority analysis in baseline in than statistical in from can function years. and both for improvements one demonstrate KOOS function and clinical sustained FDA pain significant outcomes standards. pain and compared clinically two current efficacies endpoints early microfracture analysis

in meaningfully remarked than evaluating be different them are and during our demographics, exclusion development the resulting believe compelling to NeoCart products criteria Based We on patients the Phase also results the or other conduct inclusion when either on trial, patient NeoCart compared market. the III when to how follow-ups. surgeons have of

on do virtually we why performed trial endpoint So the better and the NeoCart well miss our plan analyzed. statistical every in endpoint? than better

well trials be population of patients trial well However, expected using arms time. saw and effect controls established microfracture poorly. to a some is other whether with can criteria normal placebo treatment simply the a We not protocols, control effect where inclusion patient compared than showed the greater expected in have well that as even that is microfracture This exactly designed to the the microfracture it patient exclusion as plan. that period would do population for appropriate active do limited or a in rehabilitation statistical strict in conducted

simple. the positive our and are results were of there Importantly, and with a on proposal treatment we six defect there's events. risk benefit particularly In NeoCart FDA options with conclusion, evidence a data is the safety two the need. the believe control no comparable Phase profile, in and NeoCart unexpected microfracture the NeoCart limited has one Based versus safety from clear to knee were cartilage where other medical arm year therapies to unmet and year III endpoints profile safety totality the study, the month space

the therapy and further of relative agency recognized the results The not pathways. the So request meeting was dialogue in provide in announced the gene we’ll early that by request, clinical the with on with and safety and and these data summarizing given and to results this November let's regulatory the we around concern has an FDA the and been data notoriously provided are happened data we statistical meeting those data if discussion for cooperation There’s accepted XXXX. package FDA's acknowledge NeoCart. what robust for to submission end accepted for trials current a which with of results recent we're We not other XXth. discuss The plans, these perhaps the contacted with BLA and immediately submission not response has any BLA other It focused we're Phase to FDA meeting in and potential that difficult enroll, update FDA BLA policy potential BLA regulatory and a to meeting decisions. October exploring September or did potential discuss our clinical and naturally benefit of briefing III data. extensive held negotiations cell the assistance and a the senior standards and C we to in scheduling made We be discussions top-line with turn and benefit. We members ways rapid scheduled Along is space a active September the to comes complex down Type we data would design the schedule the so for to to pathways. be since the clinical and evolving quickly. a final remissed regarding incorporating in and these meeting decision package, additional FDA

discussions briefly BLA than submission. with the potential now our regarding other move upcoming the Let's FDA

we make and recently autologous for last with outside patient's process. BLA discussions the months. data itself have manufacturing is the the which of instead over And the As case have official cell of decade, accelerated where own cells, senior the therapies, plus our FDA and tissue commented with NeoCart XX over clinical the gene on actually functional review biologic the had percent focused fully last the FDA several we

C formal and the September discussion validation regarding another XXXX BLA designs. in have the FDA and Type The excellent We on including a feedback from included submissions and October included two and submissions our plans topics other the process over last flows then be to those room our comparability clean covering in year. XXXX data facilities in received in product

feedbacks more BLA a these review may if and well provide received for were of efficient All accepted. of

Phase planned initiation a to work III Our partner MEDINET trial Japan Japan. in the in support to of continues

or the referable including were key clinical MEDINET a prepared clinical manufacturing to These trial all grants XX the to to discussions August in that and PMDA, met held and Japan start submit development which clinical with requested they review data notification, evaluations. ensure negotiations. in MEDINET the in trial. our permission and commercialization authority, [indiscernible] As CTN, we We patients Phase other proposed III is regulatory were reminder Japanese activities for to

on engaging be coming for provide early months to data NeoCart to U.S. the based date NeoCart U.S. PMDA with and to XXXX. same the We’ll generated feedback. CTN clinical unwavering further their to We’re mid in currently that the the pleased unmet their in Japan. data of recent in with review MEDINET and based expects on the needs continues in submit believe exists support

Lastly Cornell of performance data University. agencies The to biomechanically when various And or NeoCart upon in have both demonstrates other large regarding of in potential treatment of presence These The Annual tissue further data Society advantages alternatives. biomechanical we cellular regulatory at data data to XXXX. mechanism in extra also making to of and importance most the of October recent build presented compared continue with these filings, body or regulatory clinicians were matrix action Biomedical important the support Engineering of been cartilage. Meeting our competent developed the

questions authorize approve above closes a of stock could SEC. include have we intend are completed and intends support our we until of stock Investors where this, of quarter operations. and to those. also the and BLA company and scenario company a through the an a if to funded the net stock forward comply. in our the needed These In for meeting submitting with wish price to outstanding had will first price rule. delisting subsequent closed split a with $XX.X that shareholder to those that Lastly or BLA reach stock appropriately At outcome over the generated may October, also This will The and turn to approximately to the disclosures of the Lieber the we shares that offering in our that with if will common the the the course the normal proposals. $XX XXXX need to second like SEC In days, since address longer time call this we notice several the and move mid-April of was believe disclose reverse company proxy communications XXXX employee discuss split BLA a with $X million required special we of the a from objective of and blow proceeds the enable potentially NeoCart end filing where financing company consecutive corporate forward definitive received meeting matters to is XXXX no conjunction regarding negotiations filings the may future comply ensure $X by the FDA. quarter possible in million We to necessary, continuing the company NASDAQ to point, ten additional warrants submission. I'll see of to to financials. investors with acceptance to us with if our hold Jon for the proceeds. reverse the only and Many made a of move our period with a subject gross

Jon Lieber

Adam. Thanks,

For Histogenics expenses quarter ended general XX, increase the operating to from XXXX. overall in operations due million and and ended was loss million September increases compared of $X.X quarter both research The to XX, the September reported for a $X in expenses. administrative development XXXX,

we While a and the related with focus burn managing rate, forward we on support are to to work potential expenses submission. our BLA NeoCart moving continue

staged these of make approved, also in are approaching a investments prepare if have feel potential the for necessary we the to manner. We efforts are started initial to but commercialization NeoCart

issued of of million of At should million proceeds $X.XX Neither had their equivalents $X at December the September a warrants October Histogenics compared those $XX.X placement XXXX, was to our specifics, from price XXXX. marketable increase $X.XX some the Phase from XXXX, of XXXX warrants offering. another warrants. XX, to million third and prior $XX stock common receive we third activities of million exercise XX, cash, and connection the so $X.XX and cash securities in includes million those approximately data with in the and In outstanding. of compared $X.X XXXX warrants research programs, our million higher classes quarter private in warrants from the to XX.X Adam primarily remarks as development diluted any was fund will October provision, the shares will Q&A. of potential warrants, of clinical cashless exercise XXXX and of XXXX XXXX public a expenses facility. development due third of XX have related and call expiration, in the $XX the support holders quarter work go as NeoCart to expected to NeoCart Histogenics have in these approximately increase the the analysis quarter expenses operating stock of to current be to the will the onto administrative third to III turn to general and The from million Moving operations with through before proceeds million due we with back submission. position of to BLA expenses trial, The sufficient strike quarter the at the $XX.X the XX additional into preparation Based compared concluding of underwritten an strike underlying share market fully commercialization an our to NeoCart. XXXX. approximately cash believe and diluted salaries consulting $X.XX price warrants we I and and a to of with connection and the XX.X received in common XXXX the million its of offering timing fully sales underwritten on increased offering warrants shares issued for primary through potential million currently now support We shares middle product net count outstanding plans in

Adam Gridley

judicious, forward months Jon. Management in bringing our therapy have and Thanks, challenging novel manner. investigators. a rapid yet investors, our several We're committed partners, cognizant last this that and employees for important is been to

potentially and the do products that line. clinical XXXX, one continue with new new other data of first the clinical with open are and potential that NeoCart meaningful please development line convinced and the questions. the design end year that a remain the demonstrated our adversely trial point. for of bodies. NeoCart and and we We based seek of call. the of to in result thoughtful on progress, a those FDA today's way clear Thank will which FDA approval any the relationship and with now does standard by treatment the for as approved early We'll we impact for believe conversations not standards updates the current have FDA by up may standard care represent end appropriate regulatory the benefit. We file If Operator, could We quarter working for BLA in you joining up open XXXX. to provide

Operator

Thank was you. Zimmerman [Operator Ryan from Instructions] Our first question BTIG. comes

Ryan Zimmerman

Great, can okay? you me hear

Adam Gridley

I can. Hi, Ryan.

Ryan Zimmerman

great. Okay,

for apologize an background I got the noise. here. airport We’ve Sorry,

you're you right XXXX way So can first discussions why I we about with the FDA, quarter just guys? have like limited the that Thank done? when that's November around the discussing any update you. say the of and in you you're is know of And the what the time kind and can that you to get an extend around second can from in may why And do with the subsequently also quarter mission is I that submission, you want talk discussions time but if FDA? characterize feel you what

Adam Gridley

and question Maybe that I into us will thanks Ryan can for the the Sure, take timing. last question. then the take first

the not is missed an our where point. nature data the and around easy naturally benefit, end are discussion clinical is discussion primary the naturally agency just of both for the this statistics, company So we clinical the

is additional productive. agency. And warrants is work that data The of Although with those closely of we very this believe totality discussion to clearly, them. the are something nature We're continuing significant. pretty the discussions the with

We on leads an and are the going have point us investors we that additional should your we timing will to we that an next that this question at was evolve that update. felt is ongoing feedback timeframe discussion. Naturally, of It also talking which want and but regularly couple investors. for are November. to continues Naturally, the appropriate an realize our weeks, this over continue to for

to ongoing about the think the prepare first side, as as So side, that And that based that a the everything we timeline. from or today agency quarter for a then then going have the with that facility target discussions was is ton discussions, would BLA to we agency. other a BLA, It fair we submission. internally that thought BLA. noted estimates And for manufacturing taking we would preclinical. had out prudent best a on for we on for and today with think work our the timelines course normal activity reveal. ultimately the of their work CMC with prepare be there There's us And on be ongoing worked on assuming it is the

Ryan Zimmerman

appreciate And to a really C or color, is then they regarding you. Adam. Thank respond that that you I have they Okay. have the meeting? to do FDA timeline the specific required

Adam Gridley

FDA very quickly has They appreciative that's of we've don't to where responded the us. and been how

itself. Those back have a Type if have we be calendar XX which think the to meeting. day to we’re about go determined timeframe initially targeting a typically the ultimately Type A C September call, meeting meeting, I to

cases, is each not and black this of instance. So particular white in the this so in

but been least come with would of we've got been our responsive. investors, agency sure end such us. them a turn our providing here challenged near-term. just November. we for that's has dates where They're somewhat in And speaking as to agency We're have exact However, updates I cadence has trying make And very is reiterate with working They're active. regularly and every we're to hope that a that of conclusion responded quickly. the regular to in the at the the

Operator

Thank you. you. Thank

comes question Josh next Our with Cowen. from Jennings

Josh Jennings

you hoping I good Hi, could… morning. was Thanks.

Adam Gridley

Josh. morning, Good

Josh Jennings

a your Good morning. in your and that to pathway for with that Can – – the think the – just possible FDA I us is What discussions hoping that? regulatory about was positive I understand prepared of clarify alternative could what you acceptance remarks, entail? talked you what could BLA. mentioned you help you

Adam Gridley

question, Sure, Josh. thanks for the

is about As we investors, be naturally one variety potential could is. the outlined talking as accepted of we're had outcomes, a for that BLA different

accepted from provide does be not review determination the agency. to BLA is for a the Now clear that final

It the additional advisory course, is Of It our or methods other ongoing some least that could there there to to consider get collection our could could or ways possible earlier other this. be be clarity at as and is there that review either to step. goal from data a panels be studies be that could first data.

can't to number So because different of more that agency with much closely Certainly, the on we a alternatives there continue be the we’ll table. than work specific candidly there. are

that that package of just we that time these, end that potentially we Naturally, data of on same but the review. focused course, get All we sure primary think at point. missed are making today fair indeed a is the our does supportive, presented

where that's course alternate of sort not there normal be going may so to and be employed. review And a strategies potentially is

Josh Jennings

sets? the the Thanks follow And just of Thanks. that. the does data after Types further FDA require C meaning, up for analysis to

Adam Gridley

the data we'll to Type continue think review So what meeting, existing after set. do is C I the

ways So, to analyze a data. We presented robust very our And agency that to briefing following obviously, the are imagine that the data a is. number is that what and of investors. We package can different you the meeting. there assembled data

benefit So of had X.X couple the lesions the of a analyses, greater square On at including statistical of than the thought ways covariate clinical some six months. superiority provided we one it, example, data centimeters. existing of and populations different and we at absolutely, for a looking

known the a a microfracture had They data, population instance, are at than bit plan. that say September, way types we NeoCart in presented did to analyses is look really better believe statistical that as where had particular discussions the matter, very we well. And situation back those patient well. no of we and would I because you this the do so, in In the continue which

naturally, much package. goes So, consider, potential to provide analyses. those back it but would And goal data is we provide data our our possible to is data for really the additional analyses as as additional those encourage as and to to that goal agency much potential encourage to all original

Josh Jennings

Great.

the a thinking progress absorb data, we C and for downloaded to here of so should they're set package that you be you as continued current provided a this Type and the then kind can guys And on of digest data to meeting, BLA whether analyses the about review? it the and continued that discussions make a decision submit

Adam Gridley

it. exactly That's

Josh Jennings

Okay.

Adam Gridley

you've well. It guidance part robust. FDA certainly think published relevant. I took us that are And, the to trial started we in standards XXXX it the characterized discussion. years be complete package trial. It's of Certainly, going data very XX that obviously were is to the the after

has we've We’re We're that seen of the very Of to consideration. of the that the course, current data. safe does What’s very how product apply that clinical proud proud and/or and FDA the the standards. analyzed the demographics part according would of benefit? then been and be be

Josh Jennings

for just there pathway? on that trial. the at already Or paths all the with that recruit MEDINET the FDA? there in on moving is totally And over progress thinking about collaboration a progress design independent is over guys that submitting with Japan – there, with regulatory data you should is over last and the be that and then And Great. with my is the on the Japan, the authorities contingent talk the question

Adam Gridley

well. as question quick Sure,

on seen XX was What similar naturally EMA would was congruent data. these be overall, study And while that the PMDA how requested do patient all that submission FDA trial. of PMDA, based clear the strong it a confirmatory at the and studies. as between the trial was they're a U.S. on was confirmatory we endpoints, our looking has So, you of authorities

really show to You the U.S. We have in versus of to data. pain trend some significance as have to a statistical needed function. compared

with there interpretation broad engage with there So of We PMDA. we the similarly a was naturally FDA. degree do as

work we’re PMDA. trial MEDINET, preparing to with continuing there so, for And We were the with August, notification. in clinical

our to with data XX over FDA We with continue and kick we they're And just have continues is. be off post interface we'll We've them talked very discussions. it or productive at so since that looking to naturally is that month as trial MEDINET. very before the patient next the again overall supportive. MEDINET expectation

they at the you way for see not bringing a the that development, do I We dampen look totality not patients. of already data has we only and of NeoCart many their their the same thing that think to have when patients number enthusiasm but goal the we standing have surgeons, on The the U.S. enrolled same in the by are overall based matter world. to need the the into where be study as work are unmet that of and understand waiting Japan. who no you number both done here in the is

Josh Jennings

all for thanks Great, those answers.

Operator

with Brookline Thank you. [Operator Kumar Capital Instructions] Our next from Raja Markets. question comes

Kumar Raja

Thanks my taking questions. morning. for good Hi,

get of FDA. on if a efficacy the the nature probably regard mostly to interactions based And said the strategy? terms with you be some with you once in sense did to to get BLA trying on a the by FDA that of just I the Particularly, statistical analysis they getting wanted with to account safety and So for will the earlier, own. focus as – filing, mentioned after CMC the are sense its comfortable

Adam Gridley

I think that's a perspective. fair

there's So, couple a your points question. to

Phase Naturally, seven first out years profile. XX demonstrated our XX absolutely, and go if to going is the throughout in patients or and we've you We've existing an autologous. to at and agency trial years excellent safety First, safety is the II. this had foremost be

the starting that's point. So

is data and we're having results. second, fairly benefit. of clinical that's course, the that's comparison risk The a substantial the to and discussion be And and on where going of efficacy safety those

will of context the Now clinical in of the that review data. BLA be there additional itself, analyses

there BLA cell further for where manufacturing, review is to course review amount it there of question the goal clinical our is takes these one therapies one, that for like. our also the Naturally, place data for determine autologous accepted, on a deep validation good the an is around in provide last would say strategies, question, around your is of significant that already a around would has BLA comparability, Similarly, a a certain in facilities. And portion work deep and to sufficient additional review of on we're that just the over then the into of then dive. the pretty a and absolutely, the then doing think data having That would today I review excellent once BLA manufacture. got be experience Phase clarity a may with the what the your of part So last to the step years I ability whether we've also is couple dive extent the look XX and of enormous months FDA on TMC discussions III. lead is

So that September we Steve in active as discrete overall our an speak. robust. we support in Chief been the to have from feedback. packages have Operating point. They if anticipated are on Officer, discussions get BLA the those other Kennedy, robust feedbacks All provided and been excellent and in leading agency fact very review we to those has more a review October

guidance preparing other clinical course data. this and think It for looking the we then is very holistic. data quite It's facilities, be with about the at robust I clinical way conjunction validation the manufacturing should the FDA So that criteria in and thinking is reviews. of

Kumar Raja

have And of you watching data. manufacturing, in terms any if the just following made

Adam Gridley

question. great Sure,

now the therapies. same same four, it's we've and five NeoCart as we process cell point, investors at manufacturing have in same been many years biologic at for facilities described exact manufacturing the the with over the our gene this So and last

review to made. known make top the suppliers lot is While that of lot, the goal changes the we any the closely product each changes. level that working changes extent some of the in of The have critical well FDA in And we process the to substantial making patient you're of sure of been that its any have production those materials. own we raw to industry. bringing in they're is not the which The terms is a are made leads and with complexity,

of also then brought to of been used the materials. Now, we bringing variety Bovine cells original in but scaffolds the the the the but the conversations back standards, materials, in XXXX forward been is carried used and additional exactly raw in and years, same, have the discussions specs C those extensive to we Collagen, and to in including are over Type suspend of this last all October. that September going a the We've the had two and has the which Type X elements other other part raw recent processes, couple way

Kumar Raja

Thanks.

Operator

thank gentlemen, closing for over to turn participating like question-and-answer Gridley back and Adam any now Mr. would you the call remarks. session. I in today's for to Ladies

Adam Gridley

with prospects FDA. We your taking the will a appreciate for day. NeoCart provide our everyone regarding our good with additional this as Thanks the progress patients continued conversations optimistic and Have time updates We your morning. support. we remain and both

Operator

conference. you in conclude gentlemen, for program. today's participating and thank Ladies This does the

wonderful and You disconnect a have all day. may

Ocugen (OCGN) 10 Nov 182018 Q3 Earnings call transcript