CRIS - Earnings call transcript Q3 2018

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Operator

Good morning, and welcome to the Curis Third Quarter 2018 Earnings Call. All participants will be in listen-only mode. [Operator Instructions]. After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions]. is event this note being recorded. Please now the company’s would like to to over conference the Corporate turn I Controller, Steinkrauss. Bill ahead. go Please

Bill Steinkrauss

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

on encourage Before I would financial Investors of XXXX find company’s we and statements our during the tables. the call, earnings like to will go which site www.curis.com third also These would to I are section forward-looking are at risks based may begin, expectations remind Web to that everyone our to materially. everyone like release statements the current to be management to beliefs. actual quarter and certain making related differ subject and results and uncertainties,

additional see details, For please our SEC filings.

call Executive and the our I will Officer, Dentzer. over Chief turn President to Jim Now,

James Dentzer

you, everyone, Good for third thank quarter joining business for earnings morning, our you update. us call and today XXXX Bill. Thank and

Steinkrauss, an our financial Controller available today Corporate who are me to of answer R&D. provide Head and Bill portion to results I Bob, Bill will will Joining the forward. and our made your our be financial our Bob important of we overview press they addition to of morning, going Q&A the our results, call. questions some as announcements release our during business this relate In in Martell,

perspective. take Let my minutes and you to a with few also me review these share announcements

with have of to accomplishment which we of to first-in-class development size lives patients heighten therapeutics company focus a major three findings. potential weeks these since priorities clinic, have At is of That rapid three our decided the make the fortunate September know, strategic on our adjustments to business we clinical in XX, we In announced have change and cancer. then, are our you the we some based the in a the our As the decided to on change for reassessment a a has conducted Curis, each and suffering company’s of on programs. to leadership.

Our possible to we complete in the in was programs enrollment quickly of forecasted recognize as ensure clinical time, and all the data our goal sustainable. that three trials burn as cash same At efficacy not is that XXXX. these compounds generate

building recognize of portfolio and commitment would a thank headcount of is and decrease million my all the extend pipeline allowed Their impacted and deepest Dr. today preclinical our been I to these made get like much we and expansion leadership his administrative Ali in to $XX XX% their to decision friend best. truly appreciated. reductions. we net very in and reduction and therefore, In in of Fattaey and spend moment in forecasted leader per by I dedication areas valued innovative operations. to particular, appreciation assets. a wish will expenses passion, offset reduce where clinical stage these effect have, for of are a to million burn and The general from expenditure We science, in targeted $X all clinical increased changes the has are him headcount a to a Curis quarter. would employees approximately efforts and the cash to which take He

of an Now, overview I’d our provide clinical like three to programs.

proven In durable is candidate XX% efficacious objective on refractory update clinical our safe, of lead with in which an and MYC-altered has in a responses First, lot DLBCL. to-date, achieving of clinical tolerable studies fimepinostat, and or being developed patients relapsed excitement. has generated patients fimepinostat

two with this drug, and identified have testing, fimepinostat is Double for no prognosis high, with these path Double Fast In MYC the is DLBCL clinicians data, an Patients granted on study patients gene. the with approved longer unmet earlier with worst often the venetoclax population combination this for of combination synergistic regulatory the subtype then, preclinical dosed BCLX know, year. fimepinostat, or inhibitor, genes, of in combination discussions BCLX you need fimepinostat FDA clear. the for the chemotherapy alteration evaluating a subtype patient Track FDA, In DLBCL with this and gene Hit this since venetoclax, designation this and this have effective. with patients the in As regimen an both MYC and compelling. The case based agency Expressor was we have in DLBCL. of inhibitor, best

with Lymphoma. working a and Expressor to FDA initiate with in study DLBCL clinical venetoclax the fimepinostat Double patients a currently are evaluating Double We Hit, with including combination patients

As DLBCL, tolerability combination first study We drugs data the enrolling plan in half patients efficacy of to quickly. proceed this have and and the we half start efficacy have for in both initial XXXX in already second data XXXX. of safety, we expect to

is priority as probability FDA highest the with this of Our as possible to drug through get registration quickly success.

of long-term added MYC cancer where regimen a in type goal see helpful. inhibitor Our patient’s to is is every to fimepinostat every

malignancy selective CA-XXXX, heme first-in-class and IRAKX is Our cancers. inhibitor second with highly patients for development drug in a MYDXX-altered

both the For exciting pathway, to mutation leads to IRAKX, disclosed the signaling downstream inhibiting MYDXX healthcare Waldenström's, the our of conference ongoing MYDXX and which down some in in certain over-activation with from over-activation pathway of these clinical data TLR and leads turns pathway. early patients upon cells. CA-XXXX the a of myddosome the gene this TLR of a DLBCL myddosome an study. is the dependent IRAKX. At and we over-proliferation recently, By activity

data forward exactly volunteers. have X us which data preclinical also a are compound. about to XXXX. both what Phase and opportunity consistency cytokine study makes inhibition this showed look in more more healthy drug the the correlation midyear assay While this optimistic the We tight results these testing between with from limited, seen in release, and of IL-X we exposure early matches in The of even and testing data reporting study

address developing we identified in has encouraging interested there of high checkpoint agent pathway express the a all to cancer, cell clinic a lung anti-CTLAX cancer. melanoma gastric enter anti-VISTA from and in biopsies the negative third and to In that proportion reviewing potential resistance antibodies CA-XXX’s in studies breast as that tumor been especially Furthermore, unmet expressing multiple CA-XXX immune in VISTA, VISTA Atlas need and are and that cancer, Aurigene. an cells. among the the to with the Our having targeting ability its which with is independent as tumor identifies CA-XXX, tumor in on to the be immune unique Cancer our triple study immune of the in in molecule types. VISTA, initiate our mesothelioma. particularly leading cells first benefit potential noted severe We assessed is the are clinical and anti-VISTA and only of anti-PDX not has only like CA-XXX, are collaboration cancer in literature demonstrated The and the in target program in partner mesothelioma, leverage In and clinic cancer others, with dual Genome preclinical position of models to an levels agent of VISTA. from data clinical sites appears To-date, might work XX% molecule activity and populations significant of checkpoint that vivo do with begun benefit we across shown has which is antibodies small inhibitor from have activity recent anti-PDX inhibitor checkpoints. oral has PDLX ability CA-XXX Based Curis to CA-XXX non-small in target this mechanism patients in CA-XXX a select conferences, prostate VISTA. investigators models. VISTA VISTA on anti-tumor our CA-XXX addressing development safety, tolerability a ascribed to patients anti-tumor this, to treatment. with its scientific to activity clinic, anti-tumor antibody mouse in treatment these in CA-XXX

initial XXXX. We provide data this expect study second in half to the from of

the focus that significant Before cancer. that, value. over the conclude I financial clinical would to hitting for and have over with execution, change suffering turn look With are our our milestones I’ll three of our unlocking In the to call increasing to potential and our on programs of and discussion probability and results. the of clinical reallocating we clinical a increase stating Bill speed exciting, I call Bill, lives innovative Bill. all of like resources the patients to to turn by

Bill Steinkrauss

you, Thank Jim.

update results. financial our on an for Now

in period was $X.X compared the quarter to reported For CA-XXXX, by was to XXXX of Curis to third by quarter of the compared the million wholly net sales $X.X and expense payment $X.X for the and a expense comprised expenses to of and an expenses professional of personnel to to were million of a primarily Research share, same period to the we were same increase of services, compared The compared for as $X.X interest higher offset primarily XXXX. $X million basic $XX.X XX, quarter debt development September share, $X.X and as partner and third Other Aurigene Other compared for of consisted loss royalty million to clinical and compensation $X.X partially million for were in basic for manufacturing the to million Genentech made and as The stock-based million as XXXX. was of decreased expenses the net period. primarily and periods for for General XXXX. on Curis. related period costs share of the September obligations due subsidiary the driven Revenues in revenues period the for CA-XXX for same the Revenues million XXXX. million, XXXX, the related both recorded XXXX. $X and compared loss ended $X.X XXXX same for for for in to per of costs and our prior expense administrative a fimepinostat, per period for million, administrative as of research of Erivedge. expense quarter and same $XX.X were Operating XXXX. for same XXXX third million expenses higher $X.XX XXXX owned decrease primarily Royalty, third or exclusivity the activities net million $XX.X in in quarter $X.X general as diluted of in Roche's third consulting lower $X.XX in the million year or development and XXXX period. quarter

were stock you approximately million there of the questions. million and As on of cash Operator? With XX.X for shares are totaled XX, the open common call September our outstanding. that, Margaret, $XX.X line? XXXX, we’ll equivalents cash, and investments

Operator

Should I’m now? I I’m line. my begin sorry. couldn’t Q&A the Yes, with online. un-mute we

Bill Steinkrauss

Please.

Operator

Thank you.

We will session. Instructions]. now begin [Operator the question-and-answer

Butt The first Guggenheim the Please question ahead. of line Securities. from from Adnan is go

Adnan Butt

Thanks just here. Hi, the couple for a questions. Jim, everyone.

it? about is of that am that listing XXX, XXXX then update reading First, a too resources. much prioritizing you The into or an you and lot you’re talk fimepinostat, today, order gave priority I

James Dentzer

Adnan. Hi,

Yes, it in. calling for reading you’re thanks into too answer. short the First, much is

the thinking to want makers really I accentuate have meant we clinic way that data it and develop the We of than think deserve we we about them and resources think programs had to all the on were little of get to are all our are ability to we is three here. past. that programs in more we spending the with get And great we things a in ensure these into XXXX. they the company these spend

us. Of burn that the started burn an more, for really talking about existing with unsustainable course adding we and cash cash became

just programs great move more. want So operations, all through want to science. giving we the pipeline in can of we clinic. why need sure doing don’t to We’ve We and clinical frankly got We we additional are can and that’s spend went resources build we preclinical G&A didn’t to and three these sacrifice the ensure they that we the successfully quickly make the everything to programs. that that to so

Adnan Butt

Okay.

tell from emphasis updates Second expect should question, data updates activity reading the meeting soon you and in it. to of again into me XXXX. us in judge too be which SITC much mesothelioma? to overall today seems or be I’m starting Do either if on the The allow to any XXX

James Dentzer

not in meso. So

the for talked we’ve about. we XXXX pieces accentuating So are that

of So at course posters we abstracts and SITC. will have

got And ASH. date to the XXX got very all tolerability, would the data also activity. remarks. we’ve that with helpful. data great got going is describe prepared We’ve our We’re anti-tumor I did of at be we’ve to I safety, in way just

clear, that as would that at great is – available, not in it’s other commercially also anti-tumor As the not the it’s to antibodies but the we to the anyone, anti-tumor comparison surprise antibodies look a that I data getting. say it’s not activity there, are to are as

as antibodies So can’t places frankly test look all we what to there we VISTA. look drug for the the is at that that go, we need VISTA, can that’s do to where And different place and is expressions a of VISTA, go saw where treatment could them lot tumor meso in no lots We most tumors of have a of for them, VISTA. of XX% certain only percentage really express there’s are but and high VISTA. types do looked where not meso at a of good cross

the can the trial out to lot we seems get also frankly show if to VISTA we quicker it bet, So there, generates thesis ourselves. of and that can XXXX of have run a a space one It higher company. probability and validate if we we value to thesis, a all the prove and we work we certainly for commercial like end a that

Adnan Butt

enough. Fair

India that X any do the clear, at Phase or say? be you SITC to Just you expect cannot from study partners your update in

James Dentzer

to to encourage would I them. SITC. for speak can’t really everyone I go

of company’s comment SITC. even though can’t course our partner. planning I data going We’re they’re But another to on on

Adnan Butt

fimepinostat. safety be Phase and Last Is an look before you’d one looking you the contemplated obviously there on you’ve for that – hurdle starting for X in study Are a tolerability. pivotal? efficacy there

James Dentzer

I’m to that’s if right. Bob one turn going that all Martell, Adnan, to

Robert Martell

Hi. Bob This is Martell.

really Hit Double Double as have or BCLX. by also we’re excited poor extremely disease MYC prognosis in-patient drivers, and you driven has an and evaluating because that Lymphoma know is two to those So this about Expressor

fimepinostat, that. individually two the close both disease, patients as of why compelling venetoclax had activity the the has durable that seems so and combination in quarter while response; very very teens had mentioned, response. with a pursuing to that’s so over have is And upper to But who we’re us in the had a of Jim

models, So be looking in our preclinical we activity. activity models. enhancement on profound quite will for of Based this shows those

we’ll that I fairly together that clinic And feel so we safely We’ll those on combination. see work not. any that reason as is well. the we hope optimistic see would in and our about administering why don’t

James Dentzer

Bob. me that. Adnan, let to you, Thank add

case this So when we chemo is is chemo the ineffective. hurdle, about and think the in in population competition really this patient

at the response to closer a let headed. talking last in We’re combination, the which of a more about is If get either response and fimepinostat, that really that where we we alone best. or monotherapy than it’s months I rates much venetoclax saw chemo, of rates with duration a XX% anywhere compelling near therapy kind couple we’re think

where go a lead beat. that’s can whole very which hurdle the trial space point hard all quick of and this a exactly. the design So again, was frankly need not a with unmet And is would that we severe to dataset to that really

Adnan Butt

Thanks, Jim. Bob. Thanks,

Operator

is Lawson ahead. from you. Thank question SunTrust. go Peter next the line Please from The of

Peter Lawson

Hi, Jim.

judgment Just thinking you next And VISTA patients do that cohort mesothelioma see kind update in we make about of there? CA-XXX, How when in mesothelioma to have many the of kind do patients. that call? mentioned you

James Dentzer

Sure.

then I’ll So chime start and let ask me as well. to Bob in

be So talking we’re to at going about XXX SITC.

we and are on SITC. I at – we’re well we I as said, panel a going As believe

the and dataset. talking be XXX So certainly about we existing will

to the the so have going first we the of won’t back half enrolling 'XX, 'XX. in data of that For VISTA are until dataset, be half we

we over So XXXX. but course that at this talking conference, about we the course won’t of will Bob? be of

Robert Martell

Yes, little VISTA and PDLX. compared to to the also just color quite interesting bit to is add VISTA. the a even

located cell In cell, being tumor think fact, uniquely tumor We as it’s the VISTA is an immune strongly cells on particular PDX modulator. T very mentioned, themselves. expressed quite of strongly on as expressed cells. Jim This

the really majority treated there a patients patients tend of about really Additionally and or to mesothelioma a potentially express excited increase expression. VISTA, of VISTA population tumors VISTA having don’t that’s checkpoint actually that resistance because evaluate with as since mechanism. vast strongly even XX% why And when to expression their over the inhibitors we’re need strong diagnostic have we the tumors exploring

patients way So at we them a activity. of think without great and that relatively to screen for looking having look that’s a anticancer small to number

So we’ll levels dose do that evaluation an relevant. initial are think at we key

James Dentzer

that, Peter. to Let me add

to patient is path With to Once things meso then have In can somewhat in registration VISTA that we the to strategy commercially cheapest, then in VISTA would fastest get fast the want we to get be of to for where VISTA we first we’re move path every would the first, this quickest, success get as patient Once might there, MYC characterizes long-term group. strategy probability let’s But drugs. expression to as move for at that can. that XXX, registration, the registration help. highest with registration sideways to we therapy. we’re sideways inhibitor a we MYC-altered cancer additive where the and So fastest disease, both every their an a with we to fimepinostat at similar going fimepinostat.

Peter Lawson

you. and going Got the a are then – to FDA are be data abstracts, as Thank be presentation? bland going fimepinostat, they kind of kind pretty And for and for then are final of those studies up trial the SITC should planning follow registrational where to of we wait initiations? ASH it. in you abstracts, with around they kind the And

James Dentzer

Sure.

the so So the going two continuation SITC the and abstracts, PDX on the to years. of past on SITC we’ve towards headed over be abstracts been the a PDLX path discussions are that

year vast since we on do SITC then. that have the and bulk at data the an So data presented update last we of

a for Phase you but course, X can’t India. Aurigene also know Aurigene speak Of I study as is doing in

to hurdle. And go efficacy activity. antibodies shows is tolerable a though to head-to-head anti-tumor I think path space, that safe, what that high commercial we look about to with that be So initial we we is is The got we drug is, the expect the the getting the it have, additional it path the it antibodies. would forward the data, if but shows is drug we’re it’s prepared and data shows talk forward would way the through it

for of think we towards VISTA of comparatively Then tack would success run play. success the trial very antibodies quick, we once high short, a where greater be is drug get to us approved, the the probability sideways. the then approved. if probability I And can cannot move drug order So we a in

you Peter. repeat Could sorry, I’m that fimepinostat, your For of part question?

Peter Lawson

you you the if with FDA Just where -- could registrational for are remind us studies

James Dentzer

Yes.

getting So FDA able with designation conversations course to we of part we’re conversations having and was Track our clinicians. that of benefits have with of Fast the were

as getting take and therapies the the those of liked a fastest, well. everybody really was, All Where okay, agency data. saw clinicians were course where the this for of likes drug everybody probability That’s the we data The wanted conversation what of a what combo and conversations in lab. they the from of starting Track, the success place to part lot right? obvious different liked of is of the We came tested out? highest Fast

kept course the seen as It’s know, It excited you coming Rituxan. of there most alteration drug where therapy that’s cut it in up the disease was There BCLX It’s with as fimepinostat of inhibitors no Double clinicians It’s BCLX a And that many well. The goes. is one are the exactly most the development. that is sense. MYC scientific Clearly, ever clear because even as Hit very alteration. characterized have about agency about data frankly agents I’ve other we excited path in one about was everybody about. excited so and As no by was BCLX today. have the were we makes with combination tested and But that in clinical in approved with DLBCL. different course lab. MYC

really like. getting patients that looking looks it what into We’re to and see forward

Robert Martell

of that in the I the type into laying question is go foundation a a think opportunity are approach. targeting the can back utilized. this pivoting I how than nice I Again, just ones VISTA at really SITC tumor the strategies look PDX a VISTA different And provides unique terms in to for

percentage Here, lung of a these high malignancies, ovarian as really are VISTA. super Jim of the have tumors and mentioned, including colorectal, that expression

out see the or SITC, groundwork that for at development that pivot. basically we’re so laying And I

Peter Lawson

And you. Thank you. promotion. Got on congrats the

James Dentzer

you very Thank Peter. much,

Operator

is the question The from Skorney next go from you. of Please line ahead. Baird. Thank Brian

Brian Skorney

to trial I guess Hit guys Lymphoma of Expressor? in quality you’re for Good the you the Expressor to try In study? on would planning relatively concentration clinical venetoclax, Hi. Double Double differential the I’d And Thanks are guys. expect to fimepinostat. Double both? taking with how questions. start the Are you you data prior on versus to responses stratification based Double Hit going morning, get versus doing clinical

James Dentzer

morning. Thanks push question us. to Good that joining for Brian. to going Hi, Bob. I’m

Robert Martell

Double Yes, MYC. we’re will so around patients. Double well enroll be both Hit that And parameters of the enrolled. going obviously Expressor BCLX percentage express to The cells as of set population and we’ve broader

optimal that in really study, But that the levels guide exploring onto expansion will that. And dose be phases. particular, during so we’re the where several will the enrollment of there the dose

study, Double have Lymphoma. that with will that we’re So data the during the of Double will mentioned, Jim XXXX out expecting the Hit that bulk Expressor identify we be really in that and patients coming

Brian Skorney

mg And a it. maybe mesothelioma that even patients? on think is based reason low doing XX Got Thanks. for level would though [indiscernible] to you’re on suboptimal it looks then kick that study, the just It why thoughts that on XXX in the data the inhibition subtherapeutic just still like dose seems are dose? in prior high what bid CA-XXX dose,

Robert Martell

question. a so Yes, interesting that’s really

And get with we the dose partners about some there highest full essentially. you usually to for these. understudy. understanding As it’s in dose a what call found efficacy up anticancer is I have curve to that scientific would What the we is the we try many go and therapies, bell-shaped I mechanism of with basis is think our guess tolerated as maximum terms that of still

that. we something lower is observed way that to feel the and However, – is that we’ve this is dose a the evaluate this

would responding, ability study they like the couple dose the escalate looked dose. up If it the for lower cycles. on have that weren’t at on of a patients we allow to the them to For higher they

essentially fairly able So look we’ll doses way actually to well. at be both that in

Brian Skorney

guys. Thanks, Great.

James Dentzer

Brian. you, Thank

Operator

Instructions]. [Operator you. Thank

James Dentzer

I conclude, ready think to we’re Margaret.

Operator

over and would conference for back This to Dentzer, like closing Executive President Sure. our company’s Officer, concludes Chief question-and-answer Thank to the comments. turn any session. James the I you.

James Dentzer

the Erivedge, like drug end also everyone, thank as approved that you, work commercializing they being work Aurigene as generation in therapeutics. and Curis and hard an our relationships studies development patient dedication partners, well support making difference Roche, thank drugs Thank of I’d for like for the care. operator. of families shared the team you, do you, clinical in conference like investigators their our cancer. continuous the call thank developing innovative and by thanking a importantly, productive with patients their the vision Most Genentech for partner truly and our process to Thank for today’s new our of in I’d I’d treatment for to our for targeted and to the their to essential part the of of the and everyone.

Operator

you. Thank for presentation. attending today’s has concluded. Thank you now The conference

disconnect You lines. may your now you. Thank

Curis (CRIS) 1 Nov 182018 Q3 Earnings call transcript