CRBP - Earnings call transcript Q1 2020 | Corbus Pharmaceuticals Holdings, Inc.

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Operator

Good morning 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.

It's now my pleasure to introduce your host, Ted Jenkins, Senior Director, Investor Relations and Corporate Communications. sir. ahead, go Please

Ted Jenkins

projections Good our At during listeners management’s risks expectations, may Kevin. forward-looking These like and statements this time, to state involve or beliefs, hopes, remind that uncertainties. intentions, the morning you, future. this are everyone. and I’d call for Thank remarks made

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

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

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

call Officer; Millian, Sean Cohen, Chief Joining Commercial of Yuval Research; Officer; me Moran, Dr. White, the Officer. Officer Chief Head Medical Craig and Barbara today Chief Financial Dr. on and are Executive our our Chief our our

that, over to the is my call With pleasure turn Yuval. it to

Yuval Cohen

Corbus is coming earnings active Thank anticipate the catalysts everyone. Ted. morning an year. everyone quarter for and in exciting are pleasure quarter and readouts months. conference We first multiple first It Good welcome to to call. you, We an data Pharmaceuticals XXXX my had on track

data be Phase sclerosis will this from lenabasum data data from on summer. and analysis X topline will fibrosis. in X cystic Xb followed in topline RESOLVE available by our be study remains First, Phase study schedule and the systemic These

submission, more our now are ever, readouts we FDA focusing than NDA more following on and With commercialization approval. these critical data preparing and closer

candidate that this later as year. next will We CRB-XXXX on year X as well, selection with our this our scheduled start a for also as track study Phase are also later

Head and Medical research Thank Barbara to over program. the update of provide to you. White our an now us and Officer like call turn to clinical would with Research Barbara? I Chief Dr. our on

Barbara White

To Thank and delays from studies. delivery start, significant X anticipate Phase systemic sclerosis of cystic impact you, the not on Yuval. fibrosis from we the topline X data Phase the COVID-XX do ongoing or

staff site to with on and attention staff study and Our these data the studies committed subjects' completing are to time, integrity. safety

Because of working within the of place sites, ways and contractors, COVID-XX, company with has put Corbus and consultants, new into external vendors. study remotely

visits to virtual subjects study subjects' had if We meetings about how short safety, supply all cannot sites at have have at with manage sites. evaluations in staff efficacy

these frequent We with and sites remain monitoring. in about contact data issues, data entry,

data We ongoing implementing and central have by all clinical implemented for run data Corbus. remote trials monitoring are monitoring procedures

other Our and health procedures are for pandemic. FDA the authority recommendations consistent with made

safe site resume clinical so, and to travel are when will monitoring and ongoing listed. all trials restrictions on-site for We data do

study Xb I'm and as double-blind Phase these result enrolled of follow-up after dosing a subjects have efforts, period placebo-controlled is pleased Phase about XX% subjects to study about Each study enrolled XX-day you that inform randomized of has systemic a sclerosis as X cystic completed of dosing. have XX% fibrosis complete. Friday, safety

after label enter Just the eligible more lifted. restrictions participation of enrolled label are subjects XX% COVID-XX to-date Phase the high. remains few travel X the About in waiting to note open patients associated label systemic extension in open have with sclerosis open extension, extension a

Phase cystic Based a XXXX. in X study subjects progress, topline of of the out follow. in sclerosis about have more data fibrosis we subjects remain participated on systemic schedule label extension will for than some to-date year. for dropped the The summer on study current Only and for X% open OLE data have the

summer still is anticipate study this is travel study assuming data DETERMINE is enrolled. in are active. sites. COVID-XX, have also this X the has we XXXX. already where therefore Topline of this restrictions on study label about XX% study in but be this Enrollment complete enrollment in The countries will We of Phase slowed open active. quarter ease extension third will year in schedule dermatomyositis Our during for

Our second CRB-XXXX side of type inverse candidate, to X a designed cannabinoid [Indiscernible]. is receptor that drug Type with access brain minimize with to to the seeing risk agonist. have limited we're is psychiatric CRB-XXXX the effects

and animal demonstrated on of potent glucose disease. models metabolism, hepatic lipid effects fat, influence in CRB-XXXX tolerance, has sensitivity, body fat

in on effects have additional in year. third inflammation We Phase of to quarter fibrosis start the of identified beneficial this The schedule remains and potential study CRB-XXXX assays. X

dose The volunteers. single be weight safety, CRB-XXXX multiple in of pharmacokinetics and and tolerability, normal ascending and they'll the ascending study evaluate will healthy,

the to We anticipate work selection of research months. expand by in done DMDK next our our Additional some being developed CBX compounds biologists vendors. is external toxicologists, candidate chemists, team few working with specialists, pipeline of medicinal first collaborators within concert internal and agonist, organically our

Craig call update. to commercial to turn Millian now will over program our I the discuss

Craig Millian

Thank you, Barbara everyone. good and morning

regulatory analysis We strategy a execute commercial our to potential of continue the and approval. ahead launch-ready on to

pre-launch we're deep in needs market, appropriate the scientific commercial the As relevant and our our of advance of the building preparations, and information patient understanding we a manner. capabilities, communicating establishing

capable recently Affairs of Importantly, the Marketing most teams. we a and key have to established on launch filled talented drive leaders have successful roles Medical and group a

I systemic of robust this market of who additional we call, the awareness with research landscape we year, and access In baseline a perception highlighted form first market year. payer last U.S.-based last the quarter research in sclerosis. and rheumatologists the conducted On treat survey at the of completed the XXX end

half nearly are that so who clinic and These type same reported are in our the specific disease. of to divisions trials the of from interest form of of diffuse suffer cutaneous patients patients are us. sclerosis their systemic These

there and entirely systemic other we've a consistent diminished disease, life, rate high of of is Importantly, of gathered market recognition strongly the research unmet is insights today. need that a KOL sclerosis. mortality burden majority associated with that high agreed vast quality respondents the of with This and

established perception also and as we awareness for well and research, medicines this current baseline a approaches, of treatment as Through development. potential

familiar respondents the sclerosis. are this Type mechanism a about lenabasum basis, were these stage, with example, as At as while XX% numbers growth. also room potential For And systemic receptor on familiar potential with aided treating treatment. future XX% a for encouraging were for an of cannabinoid about leaving X

a a opinion those a lenabasum remainder of opinion. are time who while about XX% note, the of On promising of the have familiar at the have with positive survey, neutral lenabasum,

after No and in later plan opinion. respondents topline have these continue track survey year. indicated to data overtime negative conduct the We'll a again, clinical we metrics to the

the exists also to Consulting conduct assessment commercial further lenabasum and robust we engaged trials. the recently to awareness diseases In three for study, lenabasum. from perception the ClearView rare considerable results a addition across studied that stage that exercise is and being in opportunity validate this independent late The

update the to providing disease On a to initiative like on introduced which this scientific how call, brief on callback over campaign Finally, I'd education rheumatologists systemic is with progressing. relevant is key provide information Yuval, turning before our our last I sclerosis.

the is systemic burden disability. devastating a and As risk insight complex, the is of and by significant campaign considerable, The that inflammation remains driven There is on systemic SSC total sclerosis reminder, a patients disease sclerosis organ a approaches totality increased fibrosis. receptor a both shows including highlights of mortality importantly, that type address that current disease. or as inflammation complications. the as drives the and And fibrosis immunosuppressive novel promise cannabinoid primarily or to anti-fibrotic need unmet agonism X specific using campaign symptoms both agents, the approach behind address

encouraging launched early March. of signs We totalssc.com, the website There with have are been which currently attracting in viewers content. to the engagement

the on visitors of For typically between of content relative is visitors example, more pharmaceutical half an the suggesting to the content on of than XX% the website. only more to than benchmarks, This of approximately consume website. XX% are encouraging half XX indicator consuming that

we've weeks. articles unmet campaign and interest strong website media Additionally, and resource. published as systemic to These the sclerosis highlight have in outlets in or need a multiple seen pieces recent points the podcasts earned and the

We sclerosis virtual ACR, in World including month in this upcoming scleroderma medical Congress Symposium month and Clinical throughout July. and the June awareness the plan to systemic the meetings, leverage the State-of-the-Art campaign

this are are other now calls. largely proceeding elements building on purposefully foundation readiness, we in commercial key I disease leadership plans our solid launch scale a with further future We efforts And all course, investment of these place, forward updating look in team which year. education and you with later with to of to

I turn back Yuval. now to will call the over

Yuval Cohen

operations and fourth update cash our Cystic Thank the brief equivalents. you, cash XXXX. Thank into quarter cash to from maintain provide Craig. of $XX.X position. on you, payments milestone Barbara. the will on and with our We I expect company fund Fibrosis $X.X quarter in hand Award million remaining in the ended the the Foundation and guidance The our now a financial

systemic readouts reiterate topline of founded we to year. second and since this including catalysts and want will two respectively. was six the most ahead, how multiple With I In closing, fibrosis readouts important ago. months the cystic years sclerosis for Corbus data several are for be part excited This data

these Let their thank and our hard times participants collaborators staff, the continued in moment me our especially challenging studies, dedication. also a very take to work, our in for and

end immensely crisis that very We will see and the this we of soon. are grateful hopeful

like we'll audience. the for this attention from would I the your open to to and morning. call thank you I the the that, turn of and operator time all With now callback questions for

Operator

Abrahams Our today Thank Capital RBC from is Markets. session. you. first from Instructions] We’ll now question-and-answer be coming conducting Brian a [Operator question

Your line is now live.

Bert Kinsey

Thank you. morning. Good Great.

mentioned our sorry, you you Brian taking Bert this for morning. this questions. So, Thank for is on

of in a is X that talk just collect XX%, in So study? around you the to mentioned I I bit dose about study, different the you patient's what RESOLVE wonder data could if loved little the think

that imputation what impact there what on would powering of collection, potential some could that the have COVID-XX of be data the plan missing you. study? any Thank impact on assuming then for And be the and the of data may

Barbara White

there A I'll things follow-up. question. XX% Barbara, take is finished the is This that have through to of end of and clear another XX-day Okay. be them of dosing yet couple

or the well XX-day the data. So we need visits as will visit safety follow-up data collect as on to last

be have So collected. we some data more to

call of and largely we However, to-date, is It complete. complete. the our what more data entry is collection also XX% page pages, than entry

to-date pleased of So with the despite, progress we're the challenges COVID-XX. obviously,

We make page last entered we're studies, data do need we will sure monitored. been every all as to has that and when of for is done

that's monitoring online. have data of when data remote sites travel begun we us restrictions, give actually Because

We have an sure data make done ourselves online, just look which it are additional data to the and sensible. access central is we where monitoring, the over we internally, data we've programming review

and than And we more and data to in of few data this up lot had that place assume that be integrity. between to point, able but maybe We able may reinstitute monitoring, that. do monitoring the there we we not challenges, a remote not ensure anticipate be at will central onsite to monitoring a delay, significant these expecting we're delay because weeks a have

So, for remain we target on the data.

in In COVID-XX. includes terms statistical the statistician powering, do will programs be powering, already data our and the projects multiple impute will impact needed closely we've before approaches of because completed and of had the for analysis had look sensitivity data. were many applied imputation also fact need those of at patients minimize we analysis This to

collected study And cystic fibrosis pulmonary data be remotely. certainly the exacerbation that in all can

that We well anticipated. study than We've few rate has helps So, anticipated, each powered. a again, we there. than been more enrolled remain less dropout patients in we

where XX% is remains to above the be, again, SSC we powering which wanted So study. it in

Bert Kinsey

you much. so Thank Excellent.

Operator

you. Thank

coming next today from Raycroft Our Maury from question Jefferies. is

now is line live. Your

Maury Raycroft

question I'm SSC score going endpoint the good readout talk softening? the and Hi, everyone questions. guys this mRSS our ask to thanks Can just morning, you my data just summer. upcoming and skin relationship an and about more taking between pivotal again, CRISS for for

improvement for the clinically And so scale? it that do of meaningfulness you sense Kellogg's what point and and mRSS, for the have on five is is FDA meaningful a said a CRISS bar

Barbara White

you thank for the So, question.

the change difference, they've median a who physicians, physicians thing the of the same important if simply improved. improvement improved they have determine say proved which subjects for haven't from patients determined they baseline, and in will associated minimal say patients is thing the ask think and who same we is believe them We what with for which score patients is the

have end what the of on study. will we at So, direct that will data be the

we'll at is able So provide the really were I and the minimal difference the when what study answer point. we'll to drive both for think determine I be on there as in want with that But within to important we data impact same don't to speculate that kind mRSS will for what to that the of And data, the regulators. as well the thing mRSS. same those publications this

Maury Raycroft

it. Got

Okay.

endpoint, secondary And review? guess the kind for a And data what interpret answers being you sense do of look that so it endpoint? like, with the during different follow-up, said? on you mRSS, for that I same how of FDA for then data what guys as a Or is would a the have scenarios your just

Barbara White

I we the totality the that and disease the optimistic that's as is thing certainly on does. reflects patients will reiterate So they think I said at CRISS we FDA our when will think data, things see important has super important to look we of when have P this hope these quite value most the outcome that we'll that assess said Craig clearly are ACR and totality that has of that's -- the treating primary, they what the the a

have also to at totality It's to sickening, outcome The of look mRSS at said best the look we mRSS to certain is And get the which been requirements measure stipulated we a of difference. on fibrosis. data. no of FDA the has a that believe we a disease, the we patients, the value skin skin that totality there is important existing and p show that, or

time, treated, and would normal patients certainly that, to regulators. expect we be will there to the able changes minimal been to from we all the the mRSS. differences treatment effect we this what have data on show reach say, important At be the baseline? And important to in expect who a to And expect, actually same

Maury Raycroft

information quick then website, there. just if Okay, that that's there's lot helpful. a And question of total wondering on just SSc a on

guess could collecting potential information all comment use you're a patients database have there website? information lot collecting website you I was and at and Just of getting of have or the a of -- some lot are patient there's that on from information that, you you're mentioned can it a the if do a consumed. you being and that on sense patient But building wondering,

Yuval Cohen

the website for Maury. directed Actually, question. Thanks thanks. to rheumatologists. the Yeah, is

opinion So, aren't in of Corbis the leaders. kind aware leaders potential necessarily but program, specifically, very the of rheumatologists opinion are and who CBX sclerosis, much of need unmet are treating are systemic for clinical The the the and agonism. aware

aware sclerosis, need not broader terms really leading reach to what treat wanted do So treatments wanted out including to the is patient of was do to directed systemic not physicians what were of website. sure who it's the of -- we we treating disease community what And a in patients unmet CBX within agonism. potential the sciences so they're make and the

collect part the build the of more those As the positions, type the a with a begin evolution be with of there'll have we conversation, context. of the and more, begin a And pre-approval appropriate site. campaign, dynamic start to content appropriate to obviously in -- to database will content information, to added

about an opportunity education, this but more sclerosis. systemic identify non-promotional, So purely learning It's is disease, great to unbranded. a who obviously to physicians, have it's interest begin in active

head of on one into website. So is But as we the we not to -- information continue then database a that potentially lenabasum. of communication intending that patient build no are and sort launch

Maury Raycroft

for Got taking it. questions. Thanks That's my helpful.

Operator

Thank you.

coming from Oppenheimer. next today is Gershell question from Our Leland

Your live. line is now

Leland Gershell

morning. for good Hey, taking Thanks questions. my

for a to me, Just before few resolve minutes the the had patients begin the completed you joined really after dosing of prices I start. call studied -- mentioned Yuval in who COVID-XX the number when the one

Yuval Cohen

I'll hand Barbara. it to over

Barbara White

partial them of we have has, end, who be had could very done don't at impute actually have Those the a assessments be can will what few missing patients but subjects know offsite. and I the number, assessments, we those. majority Leland. the absolute Hi, so actually efficacy

need impute will We that we the impute. to data

at seen significant at a said in I on a negated the as calculations when study dropout the we that bit -- part, and, not power and than again, impact by enrollment rates looked we've over impact And of a looks we lower and expected.

remain will and So believe we do for delivery adequate target both on powering.

Leland Gershell

intend that trail? And on their had willingness for then to could the that endpoint agency color initial further for with the the a of your provide follow-up, just further CRISS Phase have X, you mRSS primary one any from since primary you for to use endpoint that you Okay. Thanks. any interactions have endpoint as switch on disclosure that the to

Barbara White

Again, that, they've to would I and choice had primary guess, Corbus, interaction. not the meeting, that totality data. it, is we’ve the I about they said said choice that look didn't of They the was up efficacy So to at further that to think And clearly say endpoint clearly say that want absolutely they okay. the at well Corbus. up

I emphasize wanted on quite that they've no change. So just inputs had them we've has to that changed that time endpoint. had the further some efficacy for protocol And an about that, revised

Leland Gershell

Okay. That's very Thanks much. helpful. very

Operator

Instructions] Thank [Operator you.

today Nomura Our Marai Instinet. question from is coming from next Christopher

line Your is now live.

Christopher Marai

taking these morning, question. you situation. Hey, direction to And hard right in all thank the and good get congratulations, the on work enrolled and your studies the for Barbara with

Anyway, enrolling regarding I clarity the patients patients wanted more And OLE. little enrolled to does it highlighted XX% the on follow-up. the just a eligible were first Thank in I that does call open-label of a patient have it qualifier us, extension, touch could for upon you you the eligible? in how a What many to be remind you. on eligible? What mean? mean there Then are

Barbara White

Chris. Sure,

of of possible it, gone our comments, done the was next a to lost I'm proud them. kind and ongoing I The job. challenging studies I I just think and a as keep fantastic through for during I as you wanted because this focused. They they've seamlessly the staff question so so to thank do First have all, extraordinary shout deserves time say efforts out.

Christopher Marai

Long this week. busy day in

OLE have choosing patients what the us eligible patients? that -- know, -- remind I reason -- you patients for eligible you it could understanding was you yeah, it some just the in was qualify if So just now

Barbara White

complete had of site. in have placebo study. on because the dosing was now eligible can't last to the we extended control you part The visit original of the We've some part that very -- know double subjects blind that. And definition

they So to if any them get be for couldn't allow eligible. the we reason, last still on there would site, visit

allow that They might have COVID-XX the don’t pause to a suffer to will them as consequences of patients eligible. bit a well. of be the We want

in patients this And but over patients know, it's know we XXX don't all the number, exact than point, those that I do more fall today, that at have it's of So enrolled. category.

Christopher Marai

with understanding, just timing SSc our contract timelines you the from then data if very That's the made to before respect guess, presenting data and that, present, about, to is the study, CF data could line great. to collection analysis that chance And results of from you that and but come top helpful. Okay, thinking and know, that the to C data? relative see the there expect any I

then the you're curious expecting finally I you. on street line, with just to SSc the with expecting street. share you're And how was what share the that Thank to and top

Barbara White

CF terms is that So, will line data stands. the where of no. The SSc in to SSc results the it behind come answer is before top the study study

through, last that We last later. their will shows come have -- more slightly the time be patients to the

this will we a few the line weeks top at more a SSc that can't the about than expect less So, say be by precisely or later CF or point, amount take but data data time. of it to be give month, later out

the all and secondary’s, When results course, what information, -- expect present because to you top That's should line not would top of importance safety. if efficacy of results, present most, safety we results the line of expect. we certainly of

Christopher Marai

helpful. Thank congrats Very and again. Great. you

Barbara White

you. Thank

Operator

teleconference. reached We conclude end gentlemen, session. you. of And and that does ladies today's Thank question-and-answer our the

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

Corbus Pharmaceuticals (CRBP) 11 May 202020 Q1 Earnings call transcript