CRBP - Earnings call transcript Q1 2019 | Corbus Pharmaceuticals Holdings, Inc.

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Operator

Greetings, and welcome to the Corbus Pharmaceuticals Quarterly Update Conference Call and Webcast. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I will now turn the conference over to your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. you. Thank

begin. may You

Ted Jenkins

listeners and or first for uncertainties. call quarter time, forward-looking intentions, involve remind At everyone, call that during the state statements of may and us the Corbus this management's our to like Pharmaceuticals XXXX beliefs, I'd and remarks thank morning, made joining this expectations you hopes, for webcast. that projections Good risks update These conference future.

of the statements current the provisions Forward-looking could this Safe statements forward-looking made call expectations, results Corbus' Securities to pursuant Federal are on are actual differ on These materially. Laws. Harbor based and

a statements. not As place forward-looking on any should you undue result, reliance

the Securities in the from and and periodic These in of to the on available that by and results documents documents Corbus Securities website. are are these actual differ to those We with files company's Exchange discussed Some reports materially the website review the Commission. encourage Commission's carefully. you the could such factors Investors cause contemplated forward-looking of section Exchange statements

on the call White, Chief our Cohen. Barbara Officer. our Officer; Officer; Craig now me Chief is pleasure to and call Yuval my the over is It to Medical Officer; Executive Moran, our Chief Sean Commercial Cohen, Millian, turn Chief today Financial Joining Yuval

Yuval Cohen

Thank you, you and morning everyone thank for Ted. Good joining us today.

strategy clinical quarter, During commercialization make beginning lenabasum. while programs, our lay continue to the foundations on we our for first progress the of to

fibrotic vision target novel that the using build that set have the in skill execute of internal we the As our ensure our inflammatory drugs endocannabinoid treatment commercial of leader help continue clinical against we becoming execute system. and the to our we diseases and team to objectives, to required

and the also programs role who is expertise, our drug Director strengthen marketing manufacturing Sergei now Research Craig to Dr. team to for our including strategies. chemistry, our we we leading Millian, Atamas, to Discordia, discovery drug build our quarter, lead of and operations. start lead our Chief expanded discovery as global as commercialization commercialization Executive Officer and increase controls Commercial the to Robert and During management

Jacques, experience commercial addition, Board Rochelle of and as pleased U.S. very the join and in years has our that Baxalta, In and Directors. enhances her the to the than Alexion, expertise, more excited marketing companies, are XX Board’s for global we're compliments of and leadership Shire appointments, we to welcome such and Board. Rachelle company's

dermatomyositis, the $XX our we endocannabinoid quarter in the using the We Phase This sclerosis. X the expected CRISS in completed resolves the Lenabasum testing Phase people with in a is Data public in quarter, our in During strengthened quarter in cystic and of a a in are million $XX is the offering XXXX. modulating study system study studies the with million with study’s form first in systemic with Phase people completion upfront the subject of sheet our from primary $XX.X X the in also million ended payment and cash. potentially registrational endpoint first Kaken Lenabasum, from ACR score receipt of enrollment Phase with balance one testing of the Pharmaceuticals X partners. people RESOLVE-X fibrosis. compound summer in and U.S.A. now Xb Japanese

the people Phase lupus with addition, in NIH. In study lenabasum in being a patient first of by is X conducted

the lenabasum developing on will RESOLVE-X the year, next As for commercialization focus the we completion study, we strategies over approach globally. of

partnership, commercialization strategic global rights partnering the the Importantly, for for increase our opportunities lenabasum. for unencumbered patent lenabasum

reminder, the As potential we commercial significant XXX,XXX a for lenabasum major markets. targeting in see about patients

the outside remains track. major U.S. first Our lenabasum expansion for on

patients opportunity Japan who about XX,XXX and of Kaken options. presents systemic patients an with itself for represents Pharmaceuticals dermatomyositis important therapeutic sclerosis Japan market Corbus in a X,XXX as partnership have limited Our

announced as we milestone deal as $XXX Japan a million, the has -- due to royalties. with $XX payments payment first in additional up resulted deal quarter well million of the Japan in upfront already Our

We the Kaken continue to near as geographies our other to markets. pursuing agreement licensing by size, model to a development while capital of And noted for in similar view U.S. evaluate we partnership deals, international as longer-term previously, our company less growth. I've strategies conducive and a providing in fund

testing of committed of follow with is enter other X Looking Phase sponsor the Phase that and ahead, syndrome this or early and intention test effects of It to in treatment or successful the develop Upon to conduct completion Phase patients anticipate the metabolic Institutes NASH. end study for we NAFLD X to for NASH. CRB-XXXX at a biomarkers our Health CRB-XXXX will has on metabolism X XXXX. on of study, a safety safety, and CRB-XXXX National

track pre-IND are on our next to candidates development. We select for

We excited targeting describe near endocannabinoid you we'll And library. these potential some to are in our about of in the the the system compounds compounds future. of

Officer. end balance summer We'd update opportunities the our operations fund Dr. with pivotal pipeline. White, clinical over which provide commercialization for and let to call And our Barbara? XXXX. to our of next of that, Barbara the like and the supported of by turn be to to me on beyond detailed our Our Chief our a the continue more X data strength lenabasum Medical sheet, release will through clinical Phase development

Barbara White

of several clinical X sclerosis with XX Xst. world. one active systemic has month with elsewhere Database May asset, you, The potential thereafter. new the application an being dosing available will completed study enrollment unblinding lenabasum applications stage lenabasum filing lenabasum late soon support of in important authorization treatment assignment up. in placebo currently RESOLVE-X of Starting study will in anticipate marketing around evaluated lock top-line be and treatment U.S. follow then study we with of plus mid-XXXX. months in RESOLVE-X the of data And Phase This this was our The X and occur on is to lead a studies. milestone for Thank Phase drug Yuval.

the announced the be rather ACR Administration, U.S. was of secondary primary at score will Skin systemic will size Following to change and XX than length X the CRISS a modified Combined Rodnan Index efficacy CRISS Phase Rheumatology diffuse ACR And or study meeting for that the American X Phase a sclerosis. with Type in Response required. ACR the in No endpoint primary. C primary U.S. for in cutaneous become efficacy are the the College mRSS study we the changes CRISS Week endpoint in the Drug study. outcome Food stands core in X previous or Phase RESOLVE-X

efficacy from the lenabasum treatment program Europe in The consistent As X the Phase of a an reminder, study for safety X U.S., systemic and is at DETERMINE second study evaluating is and of the dermatomyositis, FDA of the the with affects XXX,XXX meeting. the patients our end approximately Japan. Phase is guidance Phase sclerosis ongoing. design X

U.S., consultation to Formal in Authorities dermatomyositis XX,XXX with the European Regulatory Regulatory approximately Japanese Authorities scientific and advice effects people and Japan. Europe from

disease study As one for data of enrollment for fibrosis with cystic expected track treatment lenabasum our on in remains ongoing the genetic top-line Phase XXXX. of indication, Xb for our

our advances long-term As responsible a Pulmonary has in reminder exacerbations CF with as cystic Despite major our primary half Phase and this of fibrosis. about opportunity to exacerbations and function Xb for study are testing CF, number Phase the in need study, effective treatment the to lung safe decline for address of reduce pulmonary rate for unmet there the in are severity in endpoint. exacerbations of of Xb a lenabasum pulmonary CF. people treatments needs. remains we In with

the fund awards the We Cystic to and back the to U.S. receive to who to million approximately are in that, in with call grateful Fibrosis $XX have With Yuval. Corbus Cystic provided affects program. I'll over to-date our to up Foundation Fibrosis opportunity people Europe. the XX,XXX turn CF

Yuval Cohen

Thank Barbara. you,

pivotal closed mentioned first a as quarter $XX.X Now strong of position. funded that XXXX XXXX. believe sheet funds let into million we that our company data. in through me We on financial the fourth operations earlier, sclerosis is the quarter systemic briefly comment X balance the our Phase well cash of with And I lenabasum with

that laying Before foundation programs a the and are over questions commercialization. making solid call me against towards answers, to I reiterate let clinical the in and turn our progress we

quarter bolstered to Board leadership that team expertise. bring key commercial our the During and additions summarize, we with

Analyst Development plan our in of for stage programs. to forward Corbus in drug company from to to global take strength, X commercial June. made you are launch. we select clinical update announce we York confident our rights develop in hosting example to unencumbered positioned We through continue Phase planning, and commercial initial Research and that of On a we will optionality advancing very that the novel is into CRB-XXXX note, for testing, U.S., financial strategic commercial be as compounds New strategy. with late the our our expansion approval We commercialization I'm our we portfolio candidates With FDA And progress outside our well potential look City progress. lenabasum Japan, commercial and approach and advanced pleased that continuing on Day and

will seeing the shortly. to to drugs diseases today. I'd to our fibrotic that, the questions becoming leader system. And operator of sharing we're there inflammatory looking be the Operator? the to from using it turn We in roadmap our you forward to and With over like date releasing with endocannabinoid you any and novel target for treatment audience the

Operator

Capital is At of Markets. a question from go we Our question-and-answer today this conducting you. time, [Operator Abrahams Instructions] be session. will Thank first ahead. Please RBC Brian

Unidentified Analyst

outcome? the for sort to Brian. of go those different on for if our little all and congrats more secondaries, how a question, all the Thanks might secondaries CRISS, CRISS percentage Lana it demonstrate quarter. involvement like wondering about that so, that would CRISS talk I'm aspects questions the at endpoint zero analyses guys, on looking the the profile first scores to of Couple group you of the what is sort show bit nature. taking Hey think Owen in you weigh Thanks. there And in the into need could on progress conduct And median perhaps questions would this and this you patients are that are validate you that each secondly, looking something on had again? at if of planning effects the then on of of any primary you additional or organ

Yuval Cohen

Thanks, to over to turn Owen. Barbara, I'm you. that going

Barbara White

for Owen that you, Thank question.

change formulas question Let you when baseline. it. score. others from CRISS CRISS change be published at a the me baseline the all and is weighs look most pause. there when heavily, that can is but start of it's There daunting with the contribute. calculate reality The you it. your is after mRSS weighing the The from no started score patient Everything ACR the about

clinically real So patients. of of this is which the all core outcome a includes composite scleroderma items in with mRSS simply are that This bells and assessment is whistles. relevant a not variety of

the patients and outcome HAQ-DI, health look physician in broadly that global assessment change predicted, to treatment the which global with patient disease is believe capacity composite a totality an their for at that to vital performance better better look function of So for indication the of percent than look make assessment, believe is this in the patient We the -- measure of is reflects contribute. assessment going a We an contributions it that's scleroderma this skin. with SSC. a the all lung just drug force after status rather for primary go of to

So that in in formula way the a a of my without that's one least would and to difference you opinion, works. works, scores play the these the it's multiple with you composite just highly if CRISS that see it outcomes, difference unlikely, find actual were at it, would ACR way in

that know I that see placebo. is all versus we improvement these think outcomes. I essentially expectation will our And that So

and significance, not look the that totality data believe as achieve may at the will promised but they Some do that's that I of to have necessary. will not statistical regulators the compound. at not would the the in directional of only and the it of efficacy core composite set all but importantly support of looking include each changes items, score, certainly changes those

there analysis, part organ certainly that There want worsening analyses do congestive differences based lung heart disease very I involvement based geography, will initial will in to those we step ACR the subsets all upon the be CRISS to considered of CRISS are important would multiple kinds the pulmonary different is primary these subset do artery Those there be supporting done. has or as of would be in outcome. what efficacy will score crisis given new, terms be characteristics, importantly, are things, on hypertension, of which zero, that score people be a that scoring, severe, ACR reported the CRISS subsets minimally failure. renal In say important who disease, new severe interstitial itself score. are of an regulators develop of might

the of available will important very to scoring they have them. that subset So

Unidentified Analyst

That's great, color. Barbara. Thanks for all the

Operator

The of next Raycroft is Maury go question Please from Jefferies. ahead.

Maury Raycroft

a change taking thanks question too. morning, I on Hi, endpoint had everyone. my the and questions. Good for

wondering going to any implemented that So, some there's the you this But the of require other study. items length it's size to or mentioned be that not study change that just need if protocol with I'm the modifications. actionable

Yuval Cohen

Thanks, Maury. you. to back it's Barbara,

Barbara White

Maury. you, thank Yes,

all, That's changed. the write First There be protocol. change need analysis the not of to accomplish protocol statistical needs part that to all But that's in. important happen. minor changes to the needs we some that be of this, have first of plan to done to the changes to the are

-- We validate adds already to to CRISS your they study And the there's the see this they've just questions augment that of during end of it the protocol. is our also and we if significant further. believe So that study. believe ask in got this score ability at to you’ve to of do improved validation physicians This it. patients the will the

So at single there question end of study. be the a will added the

So the pretty are really changes perfunctory.

Maury Raycroft

helpful. that's on it, then, I Got had And a XXXX. question

you So in a brain, show XXXX the pad brain? the I any the pad absence in of before. been ligand Do minimal think the still with activity displacement think would which ligand from has shown of CBX

Yuval Cohen

Barbara?

Barbara White

that are needs of to That's of is I that the at and not the a tremendous our is time, agonist does data significant have in that think to that certainly would important safety. with clinical potential will the assumption some amount tested. those preclinical provide that -- brain inflammation aspect be show. important a XXXX same to and There things It it not fibrosis such inverse such as suggests even as provide diseases [indiscernible] penetration with blood has a barrier clinical that CBX benefit liver data NASH.

is for it's think essential I first this hurdle compound. I think an question the because safety

safety it for what us -- like very explore looks So counts, brain and the it profile. humans important where barrier in penetration, which blood to is to is importantly,

the early we what that's in will So do studies.

Maury Raycroft

very Got it, you Thank very much. interesting.

Operator

[Operator from Instructions] next go Leland Company. ahead. Gershell question Please Our is Oppenheimer of and

Leland Gershell

questions. Good morning, and taking my for thanks

Again you any with Thanks. and if given CRISS the still the submitted. SAP could that powering on wondering know in the the First endpoint, being study based the change the data the was question with to RESOLVE seen on trial. us share and of is prior be endpoint change the But I changes primary to the finalized lenabasum. in with

Yuval Cohen

Barbara, morning. Good it's you again.

Barbara White

powered our indicate Leland, the we probably Thank still ACR primary you, that there's with And Yuval. well CRISS efficacy better as are powered. power we're very if calculations outcome. a trend,

we're data. be as should We be of data effects MRM things, some still certainly done I the well rank to reported those powered. ranked powered, of It will will expect and on median based based be the significant to course, treatment it for analysis well and will accounting as then ranked a an accounting [ph] of perhaps for significant. But size will forgot median. see be pretty the be that analysis that on treatment effect say, And

Leland Gershell

the Okay, hear need, CF then to have on might thoughts approval with be endpoint, may if of possibility. data on given into And a if to wanted that the the that the data need the with program, design could updated the unmet to upcoming a pathway accelerated entering that's you primary an study helpful. regard the show based question any

Barbara White

morbidity the strength the opportunities of the approval, based speed do all contributes to them. lung of account a outcome It would or the loss we It or need clinically have, studies unmet discuss half for of did CF very of exacerbations long-term to CF a for that clear on to we're whether patients is and DM, after. the cause very function in all time regulators with same it's mortality SSC to the is transplantations. a lung with significant the we For about Pulmonary -- for we going data, would have relevant that need.

the So discussion saw regulators. again, with appropriately we we would robust that data, have if

Leland Gershell

final my the thanks. development question Okay, business then just And on side.

share you with that having. be geographies potential or your on Rim maybe discussions could color be Pacific licensors other may that either further you you who If Thanks. may having or any are partners

Yuval Cohen

Leland, could you sorry, just there. repeat you second I'm I a for lost that?

Leland Gershell

it advance you with having Just discussions opportunities been you color to past thoughts about obviously you as look, to lenabasum, continuing could this any opportunities, ask to share I deals the the at commercial year? if where had And see of we could next if Kaken you course, want in any occurring, additional could just in your on for mentioned O-U.S. think as might provide secured. you be

Yuval Cohen

Sure.

careful is I mentioned to territories us have sense I the for as have in Japan don't past, obviously, really many I So in of primarily we be times this. think make commercialize answer several that ourselves. But Asia, very to try one and any that

think to will China. other come that than other I sort neighbors, territories as two be South Japan, mind the and immediate of Korea,

at think pattern those to Japan. the logical as really are I for be. to would So There make of logical same two it next, where are very the major again, us into economies, fit sense and, their look economies doesn't

are really look for But to the something that very, terms have a difficult, in things we we it's obviously committing So effort lot try very especially and of and these thought of same had we will by think from in were guess very, been outside really to. And interest of we encouraged and the the optimistic are Japan, have cautiously territories. very two that in those I quality we experience we the timing. that

Leland Gershell

Yuval. Thanks, great. Okay,

Yuval Cohen

My pleasure.

Operator

ahead. of next George B. The Riley go from Zavoico Please FBR. question is

George Zavoico

thanks thanks for and the Hi Hi, for update. Yuval taking my Barbara, question.

in and trial about, especially I'm how is in It's would endpoint since RESOLVE changed the that regarding in you the that was know trial. the from the X Was mind not very an trial? to that typical something the very, something a endpoint. of it score was this the your Or second wanted the of CRISS the like the the I beginning? change Phase have question just primary middle and came also First RESOLVE in the beginning changes, about you

Yuval Cohen

Again, to background. turn give Barbara morning I'm that over Good it going to to all you George.

Barbara White

and thanks for the George, morning, Good question.

become As our And small. it the score we efficacy indication benefit. clinical was the X that of in in to the and At in CRISS Phase as meeting gave the did it more the you the Phase which same end Phase in outcome the of outcome our said, CRISS FDA ACR short study, ACR chose study. felt the we with X We allow for score our us use time, place why approach of relatively first Phase with potential that's X primary in it. efficacy this was initially familiar the thought primary using X

to outcome a at So our thoughts that back would efficacy that based are meeting change it they After long the first their on we reasonable primary changed in new, go time. mRSS. advice, a discussions be not with FDA,

Thereafter, number or apparent. there of have more been have things have changed become a that

indication First, data CRISS sclerosis. helps globe of CRISS. systemic profile score a There what treatment effect the treatment there's to in its ACR mRSS, show to failures in CRISS looking with in studies ACR high when outcome for clinically that show key patient totality leaders around the of of systemic with multiple shift thinking ACR have effect opinion opinion reflect are same an treatment you relevant better usefulness may sclerosis. to happens has but that the been additional did as reasonably some been and validate There a the study change in

in better the So it's benefit that's just a goal outcome change to to a study, it the than reflect effects skin -- of patient score. clinical perhaps efficacy

felt Although committee, our important. of -- make group experts that advice We this is remains an international that change. had we that should very from steering who again, which

of this unusual, that results And that had make all then So acknowledging discussion FDA. meeting, went with announced to the that and that, it we we've again, we and the forward is with the following decided change.

George Zavoico

focuses it whether more systemic organ than broader a which wondering I you also thank involvement. really systemic much whether for I'm cutaneous on involvement also that. positions sclerosis, to you skin because well approach presume sclerosis means -- I'm RESOLVE population, diffuse wondering

one So, is as of that the well? goals

Barbara White

skin involvement better limited bit important skin of what of global Yes, a who with believe carry number Patients information and physicians more that address also them. on involvement. very then the involvement question. cutaneous people use again, have usefulness. the quality allowing the to can above Diffuse the elbows, organ function. knees the the It sclerosis lenabasum and doesn't systemic in scleroderma having widespread the George morbidity, a of I have have the skin start patients of lots lung will with The death. important, major patients physicians signs sclerosis information on Internal the involvement lots significant provide totality and extend significant to with and that data background score major of I but Skin me it cutaneous reflects with a believe that happens with cause is useful available of Let systemic CRISS of health that assessment cause body the to ACR just of it's of diagnosis patients. involvement, its function Both these and outcomes will life. also will usefulness be groups estimate be best around scleroderma. trunk. of a involvement. symptoms is of organ internal effects

opportunity So to yes, to want provides data them see. for have more they it that will

George Zavoico

question Okay, have thank that. XXXX. a for I you And

that antagonist. an agonist, Is So a inverse to did inverse you've antagonist. that think effective be simple and agonist rather levels And agonist this reason. an than an be for it designed there of you a it probably would appears activity some you inverse is constituent as more that than an

Barbara White

George, it sorry. go If Yuval is okay. I ahead,

Yuval Cohen

do. By all means, please

Barbara White

Yes.

implying, there have came you're might inverse to be a for indeed, of and sanction Jenrin So, our quickly with I it medicinal the George, would to with end moving And us to again, what into at And then agonist the to thank NIH. And activity and from more library the theoretically we And that's agree our mind. antagonist. compounds than we acquisition chemistry you that an there that. is reason forward the delighted what the inverse in X moving the X taking year, the on testing Phase are of an look agonist. testing collaboration to in Phase it neutral clinic had

George Zavoico

Thanks certainly for for that approach, new NASH which a an in lot interesting. makes more puts that. entirely It feel

XXXX. So thank with for luck you that. And good

Barbara White

Thank you.

Yuval Cohen

drugs of we different approach, livers. important achieved daily on I respective action, here, same the very but a same out but receptor I using between common if very couldn't collaboration is there oral more, keeping that What a the Bird share compound an placing last modification monoclonal and compound. is on our this of George, out in, mechanism having a They that will small the like different goal compound an with a are that bit very very, just a reverse the is CRB-XXXX brain. their This antibody antagonist. comment by do this in or way I remind of your with competitor Bio but by can or And a Again, results. NASH everyone just in agree differences common to a in Jansen except Rock as to some is small once molecule. to their molecule. that appear is But chemical Their achieved the CBX a fact are acts in achieving be neutralize a want of there our CRB-XXXX monoclonal antibody. we injectable month

interesting, to it's course fibrosis novel pharmaceutical and one to companies. completely the and so most one in is, and a back going your probably one X, of equals targeting this approach is the I what's inflammation those, of far, the think comment N liver, So largest is world's innovative an of of George, but

the a So at endorsement very, this of potential we for pathway. as that very interesting look

George Zavoico

Thanks for that interesting. added information. Yes,

Operator

further are at no time. this questions There

this So will conference. conclude today's

You may your your lines. for disconnect Thank participation. you

Yuval Cohen

everyone. you, a Have care. day. Take wonderful Thank

Corbus Pharmaceuticals (CRBP) 9 May 192019 Q1 Earnings call transcript