Calithera Biosciences (CALA) 8 Mar 182017 Q4 Earnings call transcript

Good day, ladies and gentlemen and welcome to the Q4, 2017 Calithera Biosciences Earnings Conference Call. [Operator Instructions]. I would now like to turn the call over to Ms. Jennifer McNealey, Vice President of Investor Relations. Ma'am, you may begin.

Chelsea. you, Thank everyone. Good afternoon, our fourth XXXX to and quarter call. conference Welcome year-end

Orford, our are President and Keith of today me Founder, Development. of Vice Clinical Susan and Vice Joining Senior Molineaux, President President Wong, CEO; Finance; Senior Stephanie

it have through be our We accessed calithera.com. could release at a press issued and website

by Provisions to the I statements the and today's may forward-looking prospects various under constitute results you forward-looking the with discussion differ Safe XX-K in future in Actual materially will including of from Factors Reform we begin, SEC. factors, as XXXX. of remind our plans the Before include the expectations, on those to of purposes indicated for our result Harbor be Risk would factors like report discussed Litigation of Securities the these filed that a risk those statements about statements Private important that section Act annual

represent not representing of looking as our forward only any as views our relied addition, be date. of any statements In views subsequent should upon and today as

While note being that, these turn if at views the this Please over point in so call this disclaim forward-looking we with to our update we specifically elect some future, even any Susan. to change. statements recorded. obligation may And is that to do call I'll

multiple we candidate building to quarter Good drugs, building a outcomes product novel biotechnology you, integrated other molecule the fourth positively conference us of for and By randomized onco-metabolism impact transformative year-end with discovered the for two and joining small was with molecule metabolism development novel we our an opportunities drive our candidate grown candidate, Jennifer. and program of In are develops as diseases afternoon, clinical on internally XXXX unmet management our therapeutic of are and advancing commercialization. Thank broad for our first-in-class later-stage each At goals. cell clinical we team timelines everyone, needs. tumor into trial, us, of pathways clinical announced of we've of parallel and clinical creating a our toward treatment immune CB-XXX we year into believe patients to development departments operational and and for advanced thank XXXX and pipeline company partnership cancer a our meet today you targeting key Incyte. with the organization small glutaminase call. inhibitor, that Calithera, expanded

through with of President as Susan Our to team year the the talented and Parlati the Research, management grown Medical of of of Affairs addition Sumita has President Vice to Vice in Frank Counsel. Ray past promotions Demo General

the with patients also are of delighted trials XXXX, patients three trials cancer everolimus, development experience will Blake's glutaminase our commercialization. program two we potential of We with Board enrolling of Chief respectively. ASCO inhibitor's at be PD-X to meeting CB-XXX randomized results placebo-controlled the we Directors. Wise, second to advance of a molecule the the Blake our therapeutic, treatment for and meeting, trial the clinical patients marketing oral and Achaogen oncology, of the Breast the Key XXXX, towards placebo-controlled presentation chemotherapy will this Officer as at In for glutaminase randomized extensive with Recent be our quarter paclitaxel in combination for include inhibitor, commercialization in Executive as with well and valuable the Cancer combination combination initiation a welcome of CB-XXX, include quarter. our year the other CB-XXX treatment the quarter with those with in Both last Phase paclitaxel. with carcinoma. presentation II fourth cabozantinib with at goals of Arginase, following. CB-XXX for and CB-XXX broad as of in February. an the epacadostat renal SITC nivolumab presentation Symposium. tumors Antonio treatment XXXX clinical INCBXXXXXX The GU planned combination of inhibitor in in of evaluated inhibitor combination XXXX San in combination and CB-XXX the solid the first-in-class triple-negative the of of combination and highlights and of inhibitor in with cabozantinib in will of or for PD-X of One trial with be cell small the of breast trials

combination preclinical as highlighting with with for Cancer agents. the to as the data and of April, anticipate inhibitor plan anticancer presenting with CB-XXX of of CB-XXX in we highlighting data, potential inhibitors. present the Research well PARP At additional American novel First, rationale Association potential classes in we CDKX/X

plan cabozantinib in to combination and respectively. and been two carcinoma, cell double-blind trials everolimus placebo-controlled named we enroll in patients randomized ENTRATA with CANTATA, our has CB-XXX Second, renal which with of

We end trial enrollment CANTATA the the XXXX expect to the of complete in trial by quarter ENTRATA open the and of XXXX. of second

submitted program been early Third, has our with collaborators dose the beyond second renal cell combination have cancer An on we of plan escalation abstract reports development to in colorectal carcinoma. PIKXCA It treated capecitabine who medical combination. patients in CB-XXX XXXX. meeting updates CB-XXX data clinical multiple academic of by have that the on quarter with

in breast update We also intend our combination on by cancer. with clinical to triple-negative trial year-end paclitaxel CB-XXX you of for

of new build drugs for Keith the announce turn will a our an update the to and pipeline continued over pipeline. by with And pioneering pipeline molecule have of we to plan that, small on end XXXX. the candidate to I call we Finally,

Thank you, Susan.

detailed our product update begin with candidate. advanced more a most on Let's CB-XXX,

combination presented support profile the has with a II treated twice February of with milligrams of combination X Patients to an The cell Phase were tolerated day. dosed oral RCC median In been control who presentation ranging from partial survival We CB-XXX of well in dose this administrated in data of trials. median focused patient X and are safety in in population. response. patients in commercial path alone. combination XXX XX% with The compares of XXXX, the therapies a in profile milligrams experienced patients CB-XXX similar everolimus a carcinoma. evaluable to randomized XX of including disease CB-XXX stable one fixed with cabozantinib, to oral patients which on currently with development for disease. were of cell clinical day historical with and a everolimus and doses prior CB-XXX a X.X In months, XX response with data Ib of known was a everolimus the progression-free to their updated of at everolimus, in once full XX addition everolimus XXX favorably which forging patient carcinoma CB-XXX renal renal we the Phase CB-XXX for

a experienced disease control. patients range and to with fixed eight day who response patients patients. enrolled and a twice experienced had shrinkage CB-XXX which at that data presented in with and control evaluable oral of X tyrosine patients once This XXX% in including included kinase also a XXX XX trial initial XX prior doses dose milligrams had patients RCC a combination metastatic XXX had day. checkpoint includes partial inhibitors of in and disease shrinkage MX two on Patients cabozantinib combination inhibitors patients oral -- from to We four with evaluable were cabozantinib inhibitors. and no, disease tumors cell who Patients XX a treated data -- CB-XXX who papillary advanced the stable and treatments, in had median clear tumor received of milligrams disease. administered who

compares the was just rate to cell had response RCC eight XXX% the partial and control who repeat XX%. population, setting. favorably disease and disease. this In a four clear line the that, response the III for who cabozantinib had in was So rate includes in approval Phase to trial patient response the rate alone rate second patients response stable patients This the

of prior Phase everolimus have cabozantinib and least inhibitor versus of of cabozantinib data trial endpoint. with and been be XX of received in doses CB-XXX and at with presented, risk Phase adverse with efficacy clear have therapy X combination all at been Patients CB-XXX clinical is well combination cancer ipilimumab-nivolumab stage combination has basis progression-free to second paclitaxel endpoint prior whom endpoint Among XXX in XX clinical the endpoint cabozantinib. initiate Patients is conducting one XX in Patients in or treatment primarily trial Symposium, approximately fully show XX% in a PD-LX by cell a metastatic in be efficacy entered CB-XXX of trial population. treated survival to endpoint. patients, patients of of study has will improvement carcinoma least VEGF to be everolimus XX that take San in ENTRATA II comprised multicenter prior low was reversible. plan CANTATA will sites a cell ratio. to with were randomized therapy, therapy randomized carcinoma. ratio. will and agent rate by XXXX. patients the median there cell of had of two XX% lines been of at prior prior or The safety CB-XXX XXXX. cabozantinib support grade treated race three X:X the evaluable receptor events and a safety survival of category primary tolerated The the approximately date the valuable in heavily XXXX Overall of enrolled milligrams in The X primary the randomized taxane. Antonio were advanced for overall clear and comprised secondary XX% Patients African XX% combination is multiple neoadjuvant a least metastatic on had The to irrespective Cancer quarter in defined CANTATA patients a plus evaluable will b.i.d. patients XX a the Exelixis XX. for with in patients The metastatic tyrosine data approximately were independent trial, X expected systemic as of patients of having review. years trial who versus in who had II assessed be for anti- including in the objective power control, Exploratory trend are of XXXX PD-LX least initiated X lines of comparing taxane all with with combination. to of treatment partial with signature. the at IMDC supply CB-XXX analysis. States prior and achieving genic into X or placebo planned previously pretreated equals assessed plus PD-X, were and in survival which progression-free evaluable stratified in primary Among agreement CB-XXX therapies at stable with August will randomized setting, in to the December, the which analysis presented renal conducted patients refractory analysis we the They be will RCC of Breast received for The with trial CANTATA The cell benefit XX% placebo-controlled setting, the either response. received either late us of is ask including prior the is study inhibitor. everolimus therapy. an or expected Phase which trials or and expression evaluable a be evaluate or the an the be to anti-angiogenic We primary objective and double-blind in a The to triple-negative the has response one-to-one disease. disease patients initiate In United in survival, the rate who of progression-free designed II secondary at with a PD-X, disease placebo-controlled XXX placebo received as occurring for in renal On randomized the XX% of targeting responses taxanes kinase responders is endpoint X patients we survival. shows breast majority Americans prior A is a reach stromal the biomarker for was -- patients. metastatic setting, a response response strongest material XX% desmoplastic In patients as

We to the November, are in data trial meeting, label of enrolling in currently combination frontline Phase of this an at nivolumab. and initial in trial from plan XXXX. both update fourth study later-stage a on quarter metastatic CB-XXX patients. the We we SITC ongoing open present In presented the II, with TNBC

and the highlight and The to objective whom this on patients XX% two checkpoint a was cohort progressing melanoma like actively would was this evaluable response designed entry. I to the patients all at responses. Specifically, partial study XX including in overall inhibitor hurdle, high on demonstrate checkpoint data, of a rate progressing disease among efficacy trial response, were entry, XX%. complete CB-XXX, melanoma response study inhibitor was enrolling achieved overall patients with order In X the control three of at rate a an

patients In response addition, to therapy. no the majority their inhibitor had of checkpoint prior

the cancer cohort expanded Bristol-Myers evaluating continue patients patients. and carcinoma with enroll the have melanoma cell cell lung non-small trial, which in with CB-XXX also is We to and combination renal

being Next, have January is XXXX mid-XXXX, first-in-class inhibitor announced oncology of immunosuppressive T-cell myeloid-derived the a a program. Incyte enrolling. immuno with collaboration trials checkpoint Arginase XXXX. suppressor responsible X, codeveloped XXXX cocommercialization in suppression. metabolic cells in plan and MDSCs Arginase enzyme in XXXX is or targeting to co-development, we for we By

twice combination designed deal will XXXX or is tract dose with types cell evaluate added to with selected Gastroesophageal stable, cancer, Combination carcinoma, pembrolizumab in expansion metastatic daily response with ovarian without evaluate trial safety November enrollment colorectal chemotherapy, and lung trial XXXX and monotherapy advanced objective include first future third The are cancer, neck updates FOLFOX, patient XXXX. microsatellite either non-small rate. design. expected cohorts to trial cancer orally with cancer, in the Phase first of endometrial and financials. our biliary half patients with squamous and evaluating clinical XXXX A plan diagnosed cancer, trial additional been patients has tumors. plus on clinical enroll opened pembrolizumab, evaluate trial of experience accumulate cisplatin expected this to in the Primary including of this administered Phase is the endpoints to gemcitabine, been And with cancer well cancer, to patients program. gastroesophageal Stephanie look monotherapy XXXX. recommended solid paclitaxel. We melanoma, or epacadostat in safety several a over and that, is II I/II great in A head antitumor or The an with year carcinoma enroll cohorts and tumor with pembrolizumab to begin and on the for the XXXX and solid for I'll it activity designed tumors, and pass will colorectal cell urothelial have The as of cell to with of XXXX Mesothelioma. metastatic a second forward to combination cancer, update combination

in the expenses recognized agreement. and and Collaboration quarter investments Incyte year XXXX. Cash, revenue was cash fourth results this points. and included the was for expenses million administered the the year, will $X.X you, December due meaningful for of General million. increase $XX.X and drive were today's and $XX.X million XXXX Research our and cost. to expenses everyone. compared administrative enable capitalized, expenses $X.X in fourth afternoon, of represents by year. in early results CB-XXX prior briefly and development review deferred co-funding revenue million development prior will The full a $XX.X XXXX was good us for $XXX.X Calithera equivalents $XX.X XXXX services the primarily and due of and as quarter of well our program Thank The revenue with for told Incyte's fourth as million. million. in the XX, financial fourth to for programs quarter of was personnel-related to General primarily were Keith, research Research the the XXXX to year inflection value $XX stage for professional were million for higher at Keith program, and quarter clinical due the increase on ended the in the were were compared investment with call. to year our offset programs, I well press release. which $XX.X decrease development from XXXX million year year. license which our collaboration our costs. million Collaboration were

for million were net from the operations Our $XX.X loss year.

or payments, or cash back equity $XXX cash, expect to we $XXX new now operating our be call and XXXX. collaborations guidance, be milestone of and sources. financial I plans will turn of will financings over additional sufficient at exclusive new with And the And the investments end million to that, XXXX our through XXXX, make partnerships, For million any equivalents between will other Susan.

we're Stephanie. Thank line questions. you, for happy operator, to that, And the with open

And first Instructions]. King question our of Securities. [Operator the Mike comes from line with JMP

quick couple of questions. A

you into the First, can Arginase Just wondering continued development your guys you that see XXX, at similar Obviously, just think on you own program combinability, collaboration eventually talk with done of hospices. wondering, about I'm XXX? Incyte. the sort you safety, sort yourselves of activity, how develops about have thoroughly for you partner under stuff XXXX? just good entering database tolerability, all a as would as the

That would that on through thing do broader program commercialize in help comfortable development we running capable to outside being and able types fully an or again, cell in RCC depends more get we the to seek do. were either the felt a a future. or would that to triple-negative approval But went partner TNBC, order the drug with program. broadly start are in renal may to that still consider Right us order to to the cancer. into the have and without tumor other Then would a trials adjusting in to and a getting and and partner we're partner if But and broaden U.S. excellent trials some outcome the we breast now, of data, carcinoma therapies other finishing be combination funded of there

That's a Okay. the second gears for just pipeline. Also, to switching helpful.

the the have that's I of year. taken know did mentioned a something towards steps that's look of expecting program Calithera previously? you've from you an don't a for a the outside metabolic would of those Or another been of that portfolio guys had should would -- kind some come just you're program, hexokinase that that active I'm next from that your I program? if remember while, that end we but for in You for to still wondering, program the introduce come while? targets

maturity, We tumor are focused is of cell no set and of and is It metabolism, longer a still is focused focused pipeline have hexokinase on also it one our on we a nearing immune projects them in the and small-molecule program. program -- a program. it's and

small a expect program molecule we to metabolism. the in clinical candidate have So in

So terms and doing it CB-XXX on XXXX. And to fear be with of in a internally. is it what own developing that we're our already will similar program we're

And our with next Matt William question Phipps of comes from the line Blair.

we talk little a the can If bit CANTATA about powering.

combo guys show, a plus XX% a You CB-XXX what in confidence gives Cabometyx guess you believe, compared extrapolating I to everolimus PFS. what improvement mentioned power historical is saw improvement benefit the but in data PFS everolimus combo you XX% the to combo? from kind PFS the the I XX% in with of to

we So date we've by combination are seen for with impressed that data to the the cabozantinib.

you I of but outcomes in in available long-term at between may seen point, lot so similarity data the us terms there, at response mechanism a think, are cabozantinib have comparing combination our data gives this everolimus ASCO it's as confidence GU, data. not in of

in improvement. to for And the that reason, achieve that we're so XX% confident ability

-- therapies How differences And sutent really when difference, versus well. some made who distribution? data but prior therapies? as the you dig you. this control you you trial and ex Got to got -- vs And when into prior are are stratifying look such realize geographic a as votrient. trying postdoc as is patients U.S. big you got of also, who U.S. getting as far and Maybe into subsets analysis median this I then, really

as PD-X IMDC patient's primary prognostic immuno two so well the of PD-LX stratification factors Yes, oncology, the prior specifically the or as -- the therapy. status are

factors the two So we're those that including. are stratification

I data to the think different the of have with grain think median were those and impact TKIs. interpreted terms I -- the TKIs salt analysis that in postdoc be of of prior

that equal terms to potential -- our the opinion the been the between not with. we're working and also a our wasn't arms concern been that's highest experts of way in that enroll So of that's in

impact subsequent equal and wanted TKI PD-X has the why activity prior of reason there enrollment been therapy on therapies. oncology about So immuno some the to ensure of question that's we prior

the for just can it. then if a Got And negative to sec. turn triple I

move So on before obviously something the additional you desmoplastic Phase the and data is you waiting true forward if you pretty this cutoff working kind are intriguing. from currently of Are diagnostic trial of II is see signature kind levels? really to with? can data true decide a Or you

we're think both doing parallel. I in

are to But data expression Phase on apply that that can are and algorithm do the most certainly same on published think time, look correlated Previously at we profile then work new aspects enrolling for patients profile of that work on we additional to regenerated that. further So our study with that have we'll we've gene those we that that we and those activity. II-XX -- data. biomarker,

we data. We So we're not more really can until just really in get waiting those of parallel. do both

Got be Or you array? IST an it of could be will think some kind it. need stain? Do to an this

discussion that's as the associated of part Yes. desmoplastic early is the signature of may phenotype. collagen you the know sort expressing ongoing now with It's fibrotic and

useful. it's possible or that stains IHC that So already be other exist certainly could either

So we're those both exploring options. of

Citigroup. comes Robyn with And line the our of question from Karnauskas

This Robyn. [indiscernible] for

a update how TNBC, on I wondering can an you if little give enrollment So was of sticking bit with going. is

African major have and Frontline You different cohorts. and line, American cohorts. X also,

equally learn randomized they are going into So trial? terms a can what's strategy the trial? in for factor about randomized also, well? dating this enrolling And we of all When

Yes.

as terms enrollment and the X pleased across So today in different of been said, in we cohorts. very all have we've enrollment, you cohorts with

these So we cohorts. all of enroll are able to

to place decide program. In TNBC next that able outcomes year, the is, will terms steps be the of studies, end for in randomized to discuss our be to by of expectation a the

a data combo the next data? When And see readout. Arginase also, question quick just we on will

across is Arginase patients very program, mentioned, I studies. aggressively enrolling The as three

and this in enroll year we'll patients combination combination plus combination of with with that a with lot So in chemotherapy pembro. pembro, epacadostat. in

this generating a be So lot year. of data we'll

presentation next of data the will when to be. guided haven't We

you but quite see know we give generating year guidance of we're data for let that when this a to as of a ready program. that we'll bit So

line question with Birchenough And comes the of Securities. our Jim next from Wells Fargo

This is for Zhu Jim. Yanan

questions of combo first Just in XXX and RCC. on couple cabo

you So treatment I if the X median in is study, the have Phase prior lines.

less sorry, study might who patients -- really limited are Phase patients CANTATA III treatment. who there X of the really, the patients to So sidelines X lines is lines lines. have many to prior with have And prior

your talk criteria could So the you how about in you've RCC? way multiple the less fit different whether look sense the setting? in might prior Phase just easy the seen about recognizing any trying agents lines? you terms you CANTATA get small in And versus it's wondering, that enroll sample into being to or line kind in notice could it's it hard of, enrollments pattern talk to through in prior you a at the more size, with prior with a for And I, also lines lines of middle treatment terms prior of, secondarily, patients of study, the the of went patient current could sequencing enrollment patients the

Great.

your X/X let prior So answer study, know therapy, X/X the I say, and X. questions. are had of of line median of either the prior number patients But patients X of of had therapy X the had -- don't as line terms if of about most the of most lines me you in prior any met patients I

pretreated, more X, of somewhat X, heavily X patients Our with been enrolled have including are lines patients therapy. that

lines we've has responses the that seen aspects in lines seen of with our these We've data one patients. in multiple therapies, most X, of of intriguing been responses think actually patients X prior therapy. prior of I

a So representing that than be encouraging. find therefore, and pretreated bar we we see higher a as population population this less to

the U.S. the front in line. Votrient In future, by and fairly of followed terms the In fact, the are setting therapy a in in the in cabozantinib. then by a in followed standard PD-X generally extent, patients in patients like the current ipilimumab not-too-distant a the in receiving the or second landscape, TKI and in by followed combination receiving other agents, current second or and Sutent nivolumab present the RCC to agent are followed cabozantinib line some line third of sequencing in That's line by sequence. frontline

So see either line, consistent with see is things moving it's into we what And increasingly had at position working GU. other out interactions TKIs. at taking space frontline immunotherapies happening with or fairly dominant the least and with a that combination that's second in we in we immunotherapy cabozantinib how ASCO the

So enrolling from the as either like line the attractive cabo following really that's sweet or second ipilimumab all approval. very [indiscernible] patients a of seem following nivolumab, of with spot that at the don't cabozantinib, right challenged we in in student be combination, to and TKI enrollment seen perspective we're its terms using

multiple prior response in setting to X say the in follow-up, rate ORR? a three, line it in X higher be As settings, I, is seen as the a fair that would see which to the prior XX% line you're Phase than to expecting

just that as data patients. that one a pretreated less to more pretreated would relatively That's small better do than hard heavily say, given expect but set talking historically, will about we're patients well

question Great. in melanoma. XXX And a then on

response that RECIST is that considered the patients duration? the is might we meaningful? of duration long is refractory kind population How And PD-X meaningful? update the have in of when is what So a data that follow-up response of

Yes.

agents of in I very that little question in setting. should think line interesting or what therapy now be with to can out or that agents. data I resistance there that because reverse the around don't PD-X that there there right clarity is that's expectation refractoriness an think is

think updates, provide meaningful? So right in in guidance the -- these what in should with that's clinically terms we'll future. -- that ongoing So update certainly have I will but expectation be? or we and when we'll external What an internally what would the discussion experts assess of data to terms the be of

the patients, enroll You stay we can so front. on that melanoma continue -- to tuned

no questions further showing now would I any McNealey closing like Jennifer at I'm call to this the And time. remarks. turn to for Ms. back

have call. and any calls that we to welcome you address today. today's us Thank Chelsea, on your thank may for all follow-up with additional joining We Thanks. you, able you weren't questions

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