CRIS - Earnings call transcript Q2 2018

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Operator

Good morning, and welcome to the Curis Second 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] Please note this event is being recorded. I would now like to turn the conference over to the Chief Operating and Chief Financial Officer of the company, Mr. Dentzer. James sir. ahead, go Please

James Dentzer

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

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

Ali Fattaey

to Jim. us joining milestones development business will the Thank half and recent you everyone, of today second anticipated On corporate for morning, review today's This you, the thank fimepinostat, XXXX as second of key Curis call as we well with with quarter company's update. and for year. for our Good the clinical progress achievements alterations. our has made like three clinical update MYC those with and our drug an benefit in which relapsed candidate has quarter, patients the demonstrated I lead particular in would advancing clinical candidates on clinic. DLBCL, in past oncology steady start significant refractory

which responses. objective treatment As in and XX a Phase Phase X trial X in responses, a patients X complete a total in resulted reminder, DLBCL has refractory with fimepinostat been evaluated where relapsed XXX a were in of of clinical

awarded XX disease durable response were tumors setting. X altered complete results XX.X responses altered cell transplant and patients non-MYC was on designation identified observed in of months. have available refractory have DLBCL. patients with experience Fast to May is patients Numerous in noted fimepinostat year duration refractory on altered an results, FDA with It a these counterparts. these patients benefit able stem Track treatment MYC their patients this therapies with these development relapsed of durable that responses the to with of DLBCL compared the by Based as the after therapy, of including prognosis fimepinostat be clinical to in activity, provide encouraging continues Now conclude alterations DLBCL. limited front-line need. we benefit relapsed have XX unmet MYC that whose Based these of publications to that for after and relapsed median in And fimepinostat a were is that refractory poorer with the MYC the

the this We the single-arm in studies -- and fimepinostat to with randomized to are control of further pivotal design, These discuss included intent continuing FDA to with opportunities trials. population. patient develop evaluate trial registration its for have clinical and combination single-agent,

we patient our that We and are fimepinostat. trial with productive have regimens highly FDA, with discussions registration demonstrate randomized concluded as combination a Therefore with of is to for formally consistent in opportunity recent preferable this rituximab-based fimepinostat in very to a fimepinostat the motivated test registration treatment controlled population. secure

fimepinostat early for further with also therapy FDA's of expand patients DLBCL. will We line, encouragement of with are enrollment lines second path may this for as treatment as the the A earlier pleased patients use approach. with provide in combination of which

needs a will population patient to whose MYC a Our primary we altered disease, on poorly a focus -- in met without patients remain believe such with fimepinostat. continue trial be

using of or fimepinostat MYC nonclinical with agents well vivo fimepinostat These In such in with to addition to in also we BTK anti-lymphoma commonly as combined agents regimens, expect rituximab-based inhibitors. study combinations BCLX used have novel explore synergistic with the safety antitumor treatment or in altered finding combination coming to strong fimepinostat work the we clinical DLBCL plan months, and examine models and activity. these initiate dose to have In regimens. additive in necessary resulted

will with of of start the combination provide the dosing this using in second these further half of status the year. regimens patient We fimepinostat updates developments on

clinical doses exposure orally uniformly at these We as profile achieve the expect cohorts randomized or the our XX-hour clinical lymphomas oral with X collaboration desired twice-daily administrations. using to VISTA we selected CA-XXX increasing demonstrated enter dose the shrinkage to a and solid enrollment combination clinic, exposure presented that have included of Including a CA-XXX only in XXX, To regimens administered three tumor these orally trial doses, safety dual as in in PK CA-XXX which well and escalation tumors checkpoint and trial level antagonist small continues inhibitory to in period, a targeting examine checkpoint doses inhibitor demonstrate milligram patients one our CA-XXX only we development. have is acceptable obtain are well XXXX. turn evidence of completed increasing XXX during administered inhibitor is an will immune candidate Using to previously an once-daily. effort up and VISTA and of developing profile. would dose high of patients. steady-state controlled partner, plasma fimepinostat as now BID. the PDLX favorable like XXX to with as to These now date milligrams the and clinical initiate modulation orally safety to observations of CA-XXX were multiple X,XXX Aurigene. patients be and In then in immune molecule I administered second CA-XXX, Phase the to pathways. first ongoing in

analysis tumor to a in different scientists regulation treatment models. treatment. of tissues clinical year. proportion its on a cancer from ascribed antagonist X antibody human and CA-XXX types, vivo trial not treatment to anti-CLAX In antibody at or We mouse of the CA-XXX of checkpoint this has tumor address high antitumor second-half do the potent significant a a in identified We prostate these potential melanoma large with studies, anti-PDX immune now from dosing in activity microenvironment in BID present antibodies expression of expression samples antitumor cohorts update the nonclinical of VISTA. Phase on including our that to array an conference the ability have been profile samples. patient VISTA tumor or CA-XXX noted have is cancer. resistance this a anti-PDX cells of with in independent mechanism this expect Through activity models in VISTA benefit pathway the in VISTA of an to as scientific in Up CA-XXX is from these in of the tumor

at We second results expect present year. in scientific these the to conference this a half of

assessed clinical these cohorts high position lines to of with is scientific in express we literature leading levels of VISTA VISTA from in in CA-XXX on one addition, CA-XXX a In cells. development. VISTA, to patients and of cancer, Based on levels cancer VISTA advance clinical development non-small of rapidly recent aspect inhibitor investigators cell gastric negative proportion cancer, lung exploit patients tumor in and most addressing express evidence breast plan activity in and of the mesothelioma. have including biopsies that the triple of noted recently high conferences, mesothelioma only its our exploring

enrollment. of further in commencement second with on the of CA-XXX patient of provide expect the in We to development year these populations updates half patients the

trial to an in Phase We’ve populations this CA-XXX large with our with trial is receptor necessary This in CA-XXX demonstrate number treatment of recently rationale apologize, enroll active assembled to is subject and a In study CA-XXX Aurigene of Curis mid-XX at ongoing continues CA-XXXX in in extend of to treatment, with rapidly with clinical partner This more study CA-XXXX provide dose progress. in Phase of year. will therefore AML XXXX. addition, prior expect access we of in signaling a the of the to India. stage Phase specific been patients not cancer patients expensive that escalation Aurigene focus nonclinical clinical a CA-XXX -- could X alterations on animal Toll-like the second current with study the cancer. that to update in from enroll AML, non-Hodgkin's an initiated is Enrollment of the evaluating providing or anticancer kinase the provide medical X and human conference data patients and and currently CA-XXX X are I to patients for significant inhibitor continues half in IRAKX X immunotherapy and of Phase for treatment naïve lymphoma, this of models the pathways. also study year with whom development a in to patients who expansion advantage lymphoma for have only who patients a in CA-XXXX patients select pronounced lines treatment a this of benefit. is later expect development clinical patients

We candidate expect the of update second XXXX at to provide a medical in conference. drug this an on half

I Developments experience and with over practicing Finally, focus a us, is with of over Dr. will recognize industry. the to to physician the room XX clinical a who Research recently with within years Martell, a like We for with Curis. Dr. candidates need. oncology has in in our to results. of that who would for I continues the patients as a Martel ensuring oncology Martel Robert great in and position been that, will in resource in financial development extensive Head formally a accepted biotech discussion believe promising pharma drug Jim Dr. turn generate be Curis call With for now

James Dentzer

Ali. Thank you,

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

June XX.X that, Operator? of totaled $XX.X and of we were securities cash investments the cash, equivalents, With XX, As will approximately common outstanding. stock there open and XXXX, for marketable our shares call questions. million million

Operator

you. Thank

first session. question-and-answer go question Guggenheim. the [Operator Instructions] begin now comes our from from Please Adnan And will ahead. Butt We

Adnan Butt

Hey. on on to design, fimepinostat. being need the or numbers Are enroll in first Where the MYC exactly now are are you question. still of so they driven discussions? and shaped? of terms in you patients would Ali, final how detect to your trial and for Thanks they disease

Ali Fattaey

and Adnan, question and the morning, joining you call. thank Good your for

we method with developing our recent to the obviously discussed our with of to them discussion We have plans approach with and that. had regarding continue continuing discussion We’ve our or designs a And and work preferred a fimepinostat. through them FDA.

the been of a very of fimepinostat randomized data makes do expecting formally to the population to that fimepinostat. us with them. trial in of put that run really randomized available patients. the forward of this scarcity is partly to This approach to are trial And a FDA control for has We demonstrate encouraging in we activity population this patient because controlled want the

we the will of and the work discussions designs nature with well. the and through to terms study continue we further In as FDA those trials, of have the

Adnan Butt

estimate enroll, you you do us expect timelines will finalize patients, discussions? Ali, for And and to the when patients of on number you those the that essentially types update for can to then of us study?

Ali Fattaey

better I do fimepinostat's DLBCL appreciate that very to that. those especially some altered different a Thank MYC in much do, say activity confident work to especially level of provides, we preliminary I will get you, regimens the with with combining Yes, of Adnan. We're population. that have the numbers. assessment fimepinostat

Some work in do that trial initial sizing of we will establishing some the of of be that exploratory have safety those exact the combination after to determined do study.

will be in XXXX. or early later this that year So perhaps on

Adnan Butt

Okay. before I a on XXX, couple XXX get meeting. mentioned a medical And in if I an ask update On can line. at back you

So or those data accepted have time? meeting at been submitted any at this

Ali Fattaey

well. to That the Conference. is agents discussion we of And data do we a for our that of SITC being meeting one forward appropriate that I the have. think present SITC of quite the the one is options is immunotherapy at to look as able of Conference course

Adnan Butt

and do different Ali, presentations? conference it will the at X same the Phase X expect data Phase be you or both

Ali Fattaey

I possibility, like the this present profile CA-XXX full like to X do the trial. think X Phase both is would I of Phase clinical we would we and think and what in in to the a

Of X in Phase quite the trial as our colleagues in CA-XXX their those are excited experience with patients partner they’re describing and about well. conducting course, Aurigene and India

of cancer we described, able work over-expression the also team types. of here in has some expect to do well. doing present to As work characterizing And I’ve the in would that be terms to present like different been as many its and some we VISTA of that

Adnan Butt

meetings is the X, both Phase that clarity via the them medical should expect should update company was for Ali, I we Phase at X looking we for, or with updates? expect them Just

Ali Fattaey

a Phase expectation year this both I that conference and at I think preference think the is X. the and them later the scientific for will Phase we on present X

Adnan Butt

the And interesting question, sorry, on mesothelioma. -- then on it's last Okay. it's update

the they or patients those year? an part dosed to there are that only is update CA-XXX going you’re be the And being of that So using? with anti-VISTA is this

Ali Fattaey

the Conference And a Adnan. particular, mesothelioma and clear, represent was the tumor you, mesothelioma to VISTA and of over-expressed looked may in is types different one second half I was that the That can investigators, just some the where cancer cancer highly with on would population tissue. enroll like cancers not work presented we in that ASCO -- the target in type a we CA-XXX case Thank other had think with of we they year. at patients at

Adnan Butt

will get you. I Thank back in Okay. line.

Ali Fattaey

Thank you.

Operator

Instructions] from our Peter next [Operator And question from comes Lawson SunTrust. Please go ahead.

Peter Lawson

number Ali, questions. a patent on [ph] kind those oral the new of my taking for just on have Thanks oral IOs been patents that you from filings of have IOs? filed, anything within learned

Ali Fattaey

done we've as a a having of molecules from work as small advantage a not been lead our we the that checkpoints. of molecule the inhibitor. inhibitors, really learned strategies other towards patents and that course those these believe question. checkpoint small of a development. Peter, we as think as part target great in any of quite have not at a opportunity that especially published, and and significant for of literature joining and clinical of using for certainly patents so interest CA-XXX both you particular well in We that of have as that call see do morning, more provide the well The track the CA-XXX obviously different context clinic, approach We Good do moment do the that. the terms that the -- compounds the geared in both immune the informative immune bit thank do and conferences VISTA are in analysis and far and PDLX We to have all an

are literature. current all and the of patent aware of We other

Peter Lawson

And think Got do you. it [indiscernible] approach Thank you. validates you your space?

Ali Fattaey

generate. of would Yes, you, targeting believe And a oral We because do we've course, of is unique a dual able certainly, certainly been so patients. that to see that’s like Peter. of good number know this advantages these for the to question. can we agent certainly Thank that a provide of that approach that far companies the advantage we an

work, is Aurigene by them. is chemistry has small yes, refining the into it's their additional But, are on. into certainly went work these we in strategy that this of not do we’re that fact line that It that which certainly encouraged our generated we of and task colleagues more spent numerous years So targeting there activity generating an are we being molecules. at and the for developing terms easy put there advantageous compounds think encouraged efforts and a

Peter Lawson

etceteras, small approaches targeting of conferences And are single the seeing well mostly IP in landscape kind arena? as agents from that targets and you and dual molecule in

Ali Fattaey

I as but think, with that’s do opportunity being will We amount see having have obviously we obviously seen advantage the the population. certainly far in And as used being is of to provided there really that’s we stage. address I small main the of targeting. molecule information thus targeting think see significant agent this mean, the a CA-XXX I limited has targeted single available, at single high us agent is such population which an duly VISTA with terms the approach a

Peter Lawson

what patients you versus from the I number X, a data? on just that the this, finally, appreciated. it's rest of for kind just world or but whether or be Phase Anything then half, with versus you’re And of venue Phase of apologize its patients? And XXX, if around U.S targeting that will second mentioned Indian X

Ali Fattaey

on presented the a and we very present past data approximately look look SITC to by to Conference, the able to roughly the Sure. being that’s and Phase levels. year and one, updates we appropriate We've worth Conference. of to In that this well X that forward studies to of at between double continue at been Last number reach those we’ve the the welcoming X a patients presented patients we and XX Phase CA-XXX year we're CA-XXX. SITC track on conference indicated clinical profile

Peter Lawson

so you much. Thank Okay.

Operator

there Dr. I’d [Indiscernible] Ali no Fattaey the back are now President further over Officer, conference for Instructions] [Operator Executive and the Company's question-and-answer to concludes session. questions. like closing to our This turn remarks. Chief

Ali Fattaey

with Thank also to Aurigene productive everyone, by I and continuous team in for that our development our the vision Erivedge, to shared drug an difference the the you, and essential to Genentech like work Curis Roche and call as cancer care. importantly, as process and partners their you thank I they to Thank approved operator. patient well thanking work discovering our our candidate. for would novel and their effective in like for in conference commercialization trials and being support of do partner families Most relationships participating for the you, I'd part investigators their for dedication end in today's patients like everyone. drug and hard would a treatment. the making thank thank of the our

Operator

is The now you conference concluded. presentation. today's for attending Thank

disconnect. You may now

Curis (CRIS) 2 Aug 182018 Q2 Earnings call transcript