CRIS - Earnings call transcript Q3 2017

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Operator

Good day, ladies and gentlemen, and welcome to the Q3 2017 Curis, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call may be recorded. to Financial host and like James today’s now Chief Dentzer, Chief would introduce for your conference, I Administrative Officer. ahead. go Please

James Dentzer

Thank Curis’ to and XXXX operator, call. third earnings you, quarter welcome

encourage begin, remind certain we everyone section would everyone curis.com our consult statements risks financial that on based our and expectations find are are actual subject will press These may to we also detail. tables. encourage Before like I to filings of to to uncertainties, would which materially. the statements, forward-looking additional I results and go and current our Investor release our related making earnings and be I to beliefs. for like differ to you SEC to

President Fattaey. Dr. Now, I’ll and turn CEO, the our Ali call to over

Ali Fattaey

thank as and joining them. today, runway. extending was a of marked And Thank good for and then each The quarter advancing and brief in well to I’d candidates, achievements provide update like everyone, morning, our at on you past Jim, drug as by Curis enumerate today. these us capital you, our multiple

in succeeded our we CA-XXXX lymphoma IRAKX drug filing specifically First, is know, enter now MYDXX non-Hodgkin’s and FDA small as which inhibitor the an mutations kinase, to intend gene. those CA-XXXX, clinic you third the soon. candidates in we with application patients IND oral and accepted our the that test has molecule in for the of harbor to

countries oral X molecule of International and with and Conference we PD-LX in the continuing presented escalation ESMO checkpoints. for the immune small Second, CA-XXX are at the this dose of from multiple trial initial inhibitor VISTA results currently Phase trial

small drug business in multiple I results. like to runway trial on candidates, MYC-altered results Phase cohort commercialize to At the Phase we would with X four they naïve to financing patients in with and of our one partner these secured XX ligands evaluable preparing These regarding to cap shrinkage XX which treated into with the immune the should milligram and collaboration extend examined molecule dose an the of part XXX in plan escalation closely administered certain are from state. the an checkpoint consistent ESMO multiple oncology CA-XXX over expect results X with doses Fourth, checkpoints. as XXXX. our continued continuous of the accomplishments registration antagonist CA-XXX cycles. through are of equity through orally from Conference. the targets our time territories once update had develop of with have first melanoma VISTA discussions we ranging begin our immunotherapy for with at initial well we sufficient tumors presentation, presented Aurigene. dose trial with patients treatment the in the of daily the CA-XXX, the initial milligram sold reach PD their Third, including FDA patients, stage DLBCL the We the CUDC-XXX cash inhibitory patients

the from X,XXX stage with good dose. observed far escalation cells T cohort dose with profile evidence limiting once those been are milligram no of in effect during thus that is tumors drug Therefore, daily increase We the us has with dose we cytotoxic escalation the the of CA-XXX the within safety consistent The toxicities prevent which escalation. treatment, also of continuing a noted continued candidate. an at immunomodulatory patients population after an

initiate now on an CA-XXX Society in patients like this we in is trial in of and also provide trial update X trial CUDC-XXX, from India, expect collaboration being Phase of at refractory B-cell or investigated with I We on centers update or patients also or treatment populations a would Phase further SITC with ongoing enrolling to a as later upon provide monotherapy of initiation. relapsed the in this X they will our to X present a plan MYC-altered DLBCL. trial lymphoma Conference of which Phase In an large its multiple diffuse this to Immunotherapy Cancer update week. select partner,

transplants Although in The the appear second-line a to after R-CHOP even to care a front-line have of with or the CUDC-XXX need stem refractory MYC-altered of to from patients with benefit is poor disease for from patients with X or population prognosis treatment benefit Patients on standard relapsed long-term and a setting, is disease have benefit durable CUDC-XXX, appears Overall, have of same MYC-altered curative Phase few cell some that clear trial options a unmet patients This and response. we that treatment. disease observed complete relapsed population in with with these Phase a treatment. purposes. salvage most DLBCL have the and also refractory X the cure. nine

we patients, discuss importance preparing CUDC-XXX FDA planning complete the to further durable Given the in with results this are this for development responses of of these in population and currently of indication. and

of upcoming We the IRAKX I candidate in gene update inhibitor in malignancies. also of these kinase present like at would Conference drug results the MYDXX by high hematologic rate CA-XXXX. activating kinase cancers IRAKX mutations now different evidenced a in expect is to ASH to altered as the number pathway December. in human our on

of which toll-like in vivo results data, in CA-XXXX a B-cell of showed anti-tumor significant in lymphomas. IRAKX, in large presented MYDXX assays, potently signaling is non-clinical receptor inhibitor and animal models potent previously activity assays, diffuse have biochemical altered cell-based We inhibits that

this accepted patients patients with in expect which Phase cancers We updates has MYDXX study non-Hodgkin’s initiation. dose the During been X patient escalation, this trial provide an the enroll this plan will are IND quarter. filed quarter, past have shown pathway. alterations and enrollment trial particular, its further in the to on with during to gene lymphoma that the during with or This TLR in we we to begin with application and FDA, now

Leukemia plan to XXXX. of Acute treatment for We these with disease. CA-XXXX merits and the testing also CA-XXXX effects of evaluate initial non-clinical encouraging of Our data clinical heme models in patients MDS malignancies showed in of of Myeloid

Aurigene, candidate, TIMX in which are expect regulatory CA-XXX with checkpoints, bioavailable that and CA-XXX for orally small molecule partnership drug PDLX of nearing to an CA-XXX prepare immune for our for completion filing Regarding studies in IND we and XXXX. enabling targets first-half is the

turn cell for we’re and to I commercialize our continued call globally Genentech’s Lastly, pleased note And that, very patients Erivedge to with of treatment Roche Jim a with advanced carcinoma. commitment for will of over to discussion the the results. financial basal

James Dentzer

Thank you, Ali.

$X.X expenses as and third same XXXX, sales and share or loss and the XXXX of For period. net to reported same the for Operating we XXXX, $XX.X of $X.XX diluted million, for net $XX.X million million, Erivedge. loss compared respectively. period as Roche’s per Revenues a for revenues the basic third a share, $XX.X of Revenues and of the quarter to $X.X million quarter million on and $X.XX Genentech or primarily in for XXXX. net $XX.X of year both quarter per third million periods for of comprise basic prior the were recorded were royalty compared diluted XXXX,

non-cash in payment expenses months September development lieu same a Curis’s development third cash $X.X in-process consulting ended related $X.X accepted General a general of and of primarily and expenses increase amendment As $X.X XXXX and due well in expenses of to activities same decrease were XXXX, which Aurigene same legal, three of million interest in $X.X XXXX. Other to and the was period obligations administrative $X.X to due for net headcount. the loan $XX owned for a of for by was of quarter increased to XX, an $XX.X the the as to license expense XXXX, for lower in option Royalty, administrative spending related Curis XXXX, included compared expense The to additional to to as compensation and of in and quarter expense administrative milestones. consisted other expense million in million XXXX primarily also Other as September expenses, in direct third with clinical for the a incurred related $XX expenses. $XX wholly charge million period stock XXXX, million expenses professional, as million loss of driven for as to stock-based XXXX. employee-related expense modification third of $X.X the in compared Aurigene, Curis’s compared the exclusivity XXXX. primarily of for of CA-XXX, agreement the primarily and the period The research and one-time million operating research and for Aurigene Research million quarter the were increased of subsidiary million development in Curis. was reminder, million of

million $XX.X of and cash, we’ll call cash outstanding. As approximately open common of XX, and million were that, securities totaled Curis’s shares XXX.X equivalents, stock questions. for investments there marketable With the XXXX, September

Operator

the Robert Brian of [Operator Instructions] Skorney comes Our from first line from Baird. question

Your line open. your from coming line button. Brian line if is Peter mute you looks please Lawson your from is like will could check be it open, next now SunTrust. the And now question our Skorney, of

now is line Your open.

Peter Lawson

Ali, the number around patients can SITC, give any of you you’re number about I us color to days was in cohort and just each thinking going possible? if at begin

Ali Fattaey

your be in hello, will Peter, the will and be it it – presentation. Obviously, enumerated for Obviously, you thank questions.

the being immunotherapy or of patients to for treatments. we that presentation of PDX close from a patients made, are than to of expect that an types present inhibitor to XX roughly naïve evaluable have disease half We quarters total the treatment checkpoints group Similar for the of from with patients PD-LX cancer assessment. approval three more those

for SITC. sort presentation the enumeration of that’s at coming So the up

Peter Lawson

Okay. it follow-up And patients? would those now what kind for be of

Ali Fattaey

question. It’s good a

patients countries and patients South types the of from than those the with patients that group more callers, of half as and predominantly have year, where mentioned, approved on majority our Spain. enrolled So an U.S. that that this group checkpoint naïve are again, and have the two rest for are one been ones most of I cancer antibody sorry immunotherapy in the enrollment been group, one Korea the again, have the the that the are And the treatment

at looking been been patients we’re months patients for six category. have now some over now treatment – in that So on have that that

Peter Lawson

you. was Thank you it multiple trial, then mentioned Indian sites. And the X Phase

Tata I beyond that’s Memorial? that’s, guess, So

Ali Fattaey

there needed, site of able be correct. the to are But That’s we Memorial the in look the at in cancer for a leading of other the type. enrollment these. to few and numbers particular, is as get centers patients Tata that the one

interested in enroll. quite and we’re to So keen

beyond again, enrolling once centers trial well initiated, be as that of slightly and we’ll And just as Tata as able study, details expand well. approved will Memorial full this We to give is is as the well. I think,

Peter Lawson

again, that we from X? we remind And And that update Phase an would doses see when using? could the me be what’s

Ali Fattaey

be, we the in the to It of Phase X yet that I that cleared for example, though needed particular Phase design in milligram the we for the of XXX the actual or possible context that dose dose now X terms dose. beyond that as know Sure. a we with of we’ve think And don’t have indicated the is have dose go study that in then that cleared would needed that. that if trial. and initiate

We that said, the, terms the possible at I given give details come our study. a initiation. patients can is beginning late it And it’s do X, think either time Phase as started. could any into that hope In more get year that is the we’ll on year or of next trial of that on this the

well. within XXXX readouts should that from And as have study so we

Peter Lawson

you Thank much. Okay. so

Ali Fattaey

Thank you, Sure. Peter.

Operator

Thank you.

line question from Shibutani next the Chris from Cowen. Our comes of

Your now open. is line

Chris Shibutani

a Good that CA-XXX – that seeing? can patient On the as more data, of we data further should on bit kinds more granularity responses about as of characterization learn you’re in that little options the expect far morning. terms biomarker getting of Thank to you you. first of

Ali Fattaey

thank for morning, Good question. Yes. Chris, your you and

roughly SITC given the guided presentation. the ESMO months after two we’ve for previously As before presentation, obviously,

team already. In patient we will I and question, we’ve the majority of as of terms number Peter, eligible the biopsies expect for a Peter’s that ensure of response treatment then discussed described that pre be evaluable in what described do We have at the biopsies tumor we the – of doses and or extent numbers, significantly stay quite larger also their to that to disease. bit respect some spent any has tumor with – this tumor of to patients treatment and cytotoxic again, for the on efforts for patients of post to patients That’s profile analyzed more available an And profile been the CDX the shrinkage we to have those the us. biopsies. within duration to patients. present patients focus is then expect for And for of cells of we of area the with respect group tumor a really of T are

Chris Shibutani

And then frame I thinking you yet have think your hand, the believe scenario based you resources financial the think about occurred. you we would FDA, us portfolio your that said upon go-forward discussions with you Difficulty] CUDC-XXX, realistic [Technical there? what on with maybe not for the Can current be what should be

Ali Fattaey

Sure.

So, we it in is said, here tried terms but with data described this DLBCL the historical What of as clinical in which provides, I well. patients we benefit at during put previously those it provides it CUDC-XXX as as both of and perform. that how to look patients, that for the context call,

population very to be complete patients. And relapsed/refractory with DLBCL those general, in rare. for of of the responses durability be terms MYC-altered tend durable think to respect and in tend I responses definitely rare to complete their

of of course, population the work obviously, this this with that provides discussions prioritization, resource Therefore, approval on, for and we that have our a for population, same As our really as I goals benefiting data, is, to obviously discussion require With respect this merited see us of at the Therefore, it’s team has it. have of with we benefit course, at from this it CUDC-XXX context are for serious we a candidate that FDA. the studies the and in the of that accelerated less And were CUDC-XXX amount with think second exact to indicated, the in is perspective preparation the to would of we in of to of approach us that this serious data, historical, respect the is the which is Curis point discussion of FDA would at do FDA. clinical respect resources this FDA design With where expenditure I benefit is the allow potentially same with with studies. that’s What a drug the to and defined candidate mentioned drug of this clinical that a with from possibility lymphomas. the associated a terms with it’s the focusing a path it that to most that. we for randomized patients benefit portion have clinical study put is designed a discussions, on, that and for preparing perspective, it’s data stage.

Chris Shibutani

Great. Thank updates. you for the

Ali Fattaey

Chris. Thank you,

Operator

Thank you.

of next Butt Adnan Guggenheim comes from question Our the line Partners. from

Your is now line open.

Adnan Butt

the first. good morning, Hey, guess, folks. I Thanks for question. I’ll XXX start with

are For that will patients? the SITC MYC they XXX patients the update, all additional be at

Ali Fattaey

our Majority the of that’s been predominantly milligram patients are treated that XXX and milligrams we patients doses. where have expanded XXX the

Adnan, that the correct, ESMO since to majority that’s be presentation, would dose that’s doses done So been from it correct. have

Adnan Butt

you seeing at something could between be Okay. activity at greater that to level? expect parity Ali, that’s for Are SITC, do X,XXX more that the what And, come at or you to is XXX? point now, exposure if about mg be going on patents

Ali Fattaey

a it’s if between Yes. any context. and the we patients exposure or terms clinical readouts milligram tumor will, question in putting biomarker XXX this whether began you a from perspective, know an starting biomarker from accessing of correlation, biopsies excellent in it’s collecting dose. Obviously, at and I

point. at that some as similar very we dose We are evidence obviously, informative to what we’ve seen us, the we’ve tripling exposure those We calculations activities where we’ve we anti-tumor two but in for clear at So correlation doses, biomarker both of try bit is that. and seen feel do only some being for observed that doses. point a into so the X,XXX going to the studies. probably milligram a and to at the tumor and difficult clinic, what think dose a think do based will of vivo look in between basically be this we’ve to also comfortable XXX able observed also activity on confident back non-clinically little that more doubling where that animal a in see shrinkages in the drive patients this of reflective that and because ESMO sense that presentation, is dose, We that we is the in do

Adnan Butt

get a do How level helpful. you high up safely? that’s Ali, to at dose expect

Ali Fattaey

at in monkeys both Obviously, into studies, the studies. drug, taken dose that drug – it at what animals to we the had out the frankly, field, level, recognizing efficacy excellent than at levels have fairly class that’s dose this will, also non-clinically we’ve that point mouse checkpoint are In the safe Yes, very question. particular escalation XXX model an mouse is inhibitor in of currently is highest terms in safe a the the antibody. animal drug. coming clinic. for and exposure and relatively profile a want are the significantly if you in we This have we of – that in I higher roughly But to levels milligram exposure tested or

So we can toxicity. go dose limiting without go significantly can approaching is we higher, that, higher expectation our although,

I that in is of we you what of we may probably saturation activity at us think, question do assessing say, reached terms for terms asked that the most tumor doses in of more feel first helpful Those have at that biopsies – a point. the this are if important biomarkers. the one terms of in I

Adnan Butt

or data will are that’s helpful. tumor you be Okay, you much very And say SITC? able at how did say to biopsy

Ali Fattaey

ESMO didn’t tumor to assessing the biopsies strong more We fairly we all point. but we have in what of we effort presentation. than that a up significantly – this Conference it’s I at the enumerated, available had had did processing and

Adnan Butt

for within then just lymphoma? NHL, MYDXX specific screening how one XXXX, you on And will And process of looking be type Okay. for any mutations? common

Ali Fattaey

acids very is The of possible is on people mutations, mutation That there MYDXX genes or a is the cancer XXX analysis biopsies. common amino to one that for at Yes, that it’s screen. panels screening Adnan. prevalent a use mutation good question, from

of to We XX%, to these that we have for lymphomas example, methods. population macroglobulinemia obviously in by some tests disease patients this simple as subtypes – DLBCL, to sequencing of that up MYDXX that one, dose There enroll also MYDXX toll-like defined MYDXX, mutations those These would high it the mutations. that have also large get lymphoma the in Waldenstrom’s with escalation. diffuse ABC be signaling lymphoplasmacytic of can prevalence we that may detect appear to a mutations. does also that get in of receptor sub-populations prevalence is define activated like well are mutations certainly patients are enroll. populations as to as that expect that study B-cell a appeared able we all would subtype well, we be lymphomas other into exist of are by in the also the expect necessarily developed and not and then have laboratory all that to will would have have we would to The very particularly

genetic order in point in specific expansion the dose go stage However, we at point to is some closer this selection the escalation XXXX at populations. will expect of forward to to apply selection selection not we a accelerate would when

Adnan Butt

Okay, helpful. Thank you.

Ali Fattaey

Adnan. you, Thank

Operator

from Instructions] Thank from you. Robert the question line comes Our of Brian next [Operator Skorney Baird.

now is line open. Your

Brian Skorney

guys. morning, Thanks taking the Hey, good for question.

versus cycle lesion will criteria then abstract with the It response the on XX patients end seems SITC patients abstract the by of recess kind on by this the XX% in that cited looking in looks further a And evaluable the evaluable September XX% bit like book of patients the confirm through immune-related we’re presentation two. the swallow like for September. actually in melanoma at It the I that predates in weekend. there’s little abstract patients And presentation. reduction just XX want September. went to that Just

tumor of if in does just presentation? what that September have it was like, criteria or in the and target. patient So I look Thanks. it’s know don’t reduction that response by recessed kind terms you the IR can But of you review

Ali Fattaey

think, Sure. Thank general, I shows your abstract beyond Yes, we’re you, what SITC. Brian, question. for in for the

of receive to for immunotherapy approximately disease I had terms have their well time patient with patients would naïve total referring – treatment to the those SITC. again, at roughly the And question, be of present As evaluable shrinkage first. the expecting of will presentation then tumor has on size XX the as multiple The four, ESMO, at presented indicated their patients at data further patients and particular time of that patients with that of being at is cycle that cycles to tumor and And treatments at melanoma. cycles at you’re in Peter’s or their shrinkages three to I presented tumor over that SITC quarters patient we we two. data believe the continued

Brian Skorney

Thanks. Okay.

Ali Fattaey

Thank you, Brian.

Operator

time, Fattaey the you. I over would closing call any at I’m questions. back remarks. to And this Thank further for showing turn not to any like And Dr.

Ali Fattaey

you, I’d with candidates. the that thank for team productive in work for Curis thanking by and you, the continuing. end partner, and relationship everyone, call And we our joining the have also like to advancing today. our Thank hard the them call their drug for Aurigene,

Roche We and their commercialization like with to of thank work Genentech also Erivedge. for

investigators candidates our to a development support importantly, with participating our course, making of for thank and potential would Of for trials candidates. their But clinical drug reality. our our their families and drug on like most patients we the

everyone. you, thank So

Operator

you the gentlemen, participating and thank may program, and disconnect. Ladies Everyone, day. all have a you does great conference. conclude for in This today’s

Curis (CRIS) 7 Nov 172017 Q3 Earnings call transcript