Calithera Biosciences (CALA) 8 Mar 192018 Q4 Earnings call transcript

Good day, ladies and gentlemen and thank you for standing by. Welcome to the Calithera Biosciences, Inc. Fourth Quarter 2018 Earnings Conference. [Operator Instructions] And now, it’s my pleasure to turn the call to the Vice President of Investor Relations and Strategy, Ms. Jennifer McNealey.

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

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

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

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

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

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

are positively programs and afternoon novel as call. outcomes that novel develops therapeutic Calithera, that development diseases. towards patients for At creating we Thanks, tumor oncometabolism joining us made we CB-XXX is inhibitor, as arginase oncometabolism an and you and novel continue of XXXX known building time our conference of biotechnology targeting telaglenastat, partnered By which on drive and molecule commercialization. advance clinical good cell Thank robust patients a of company the is glutaminase versus carcinoma. the randomized cancer are treatment candidates, to of for pipeline we completed candidates: everolimus for This quarter, telaglenastat for impact programs our fourth stage Jennifer with today the with inhibitor opportunities renal and multiple the significant In alone other pathways we XXXX, plus significant quarter telaglenastat drug, metabolism program. clinical for clinical immune our cell are product also We late-stage everolimus everyone. end of and on our year progress fourth small through combination integrated treatment drugs our studies. building progress a comparing to of two our Incyte ENTRATA the trial clinical enrollment

randomized We in of global trial versus clinical telaglenastat with We broadened for cabozantinib our new two program combination carcinoma. renal And cabozantinib also our to comparing the we continued development and through CANTATA alone enroll earlier-stage that our trial telaglenastat patients the cell trial XXXX Incyte from this with clinical the data half this collaborations data anticipate Pfizer. and continue momentum year. of with in ENTRATA from XXXX both program, expected in with second will partner the

therapies need. discovery continues the unmet drug with to produce candidates drug areas be novel internal Our of highly new differentiated to team in potential

We XXXX. drug development novel have molecule entering small clinical candidates two in

treatment the for treatment cystic cancer. and now oral of Phase studies, CDXX inhibitor arginase in of molecule X novel the a an for which CB-XXX, is small one inhibitor fibrosis, first The is CB-XXX,

the data telaglenastat, to of achieving In XXXX, our for we forward near-term. to look the in top in following trial move inflection the programs look to and and enrolled, expect half expecting to goals: number of each report forward line value be As in fully ENTRATA development, a second XXXX. milestones of the points we we important forward

patients We with by year-end. also the trial, to trial plan X enroll Phase CANTATA XXX randomized a approximately

data meeting XXXX. of at expect partner, our in For the XXXX, to and half Incyte, present second medical a we

program. this the meetings CB-XXX, for look and of have in we an at XXXX. the X Phase clinical expect our update updates presentation we and has forward for achieved initiating a on will And a trial on Keith abstract X describing trial to a with for CB-XXX, to And accepted been call preclinical Phase programs. CB-XXX goal For initiate in pass March, the to XXXX over AACR that, additional I

Thank Susan. you,

begin inhibitor detailed update a on product Let’s candidate. with our telaglenastat, more advanced most glutaminase our and

X as in with We plus second with for double-blind treated renal with conducted a prior patients, The of be will previously in including X safety of lines telaglenastat includes ENTRATA least Patients two a randomized of plus clear the telaglenastat trial, are is a The being XXXX. reach ratio combination everolimus in The United or assessed and forging analysis either evaluate clinical currently everolimus treatment VEGFR-targeted telaglenastat RCC multi-center to everolimus of trials the which efficacy program sites therapy, The half designed kinase survival inhibitor. track is in enrolled randomized study recently to XX at commercial had This on late-line for endpoint in are We primary everolimus. focused The enrollment. endpoint tyrosine of at combination path telaglenastat clinical primary remain of randomized progression-free in systemic X:X being cell in States. on secondary endpoint. Overall a the survival. the telaglenastat been completed carcinoma. is RCC. patients to cell Phase trial who placebo

cabozantinib of patients, telaglenastat the primary telaglenastat are combination combination and survival review. have GU survival cabozantinib meeting progression-free trial data PD-LX update global Phase being recently X be patients combination key either trial anti-PD-X, as Overall with including independent in In X the secondary enrolling presentation by are potential. advanced plus is placebo-controlled enrolled as the in of February. disease evaluate combination. stratified ratio XX prior cabozantinib. by clear metastatic approximately will prior in risk ASCO Xb agent We therapy, cabozantinib previously be cell least a X carcinoma presented and Phase category in kinase X and randomized, anti-angiogenic with were Patients designed of prior mTOR will at or telaglenastat RCC lines It patients, is versus oral IMDC placebo We XXXX treated patients the Patients XX received KRAS-mutated in arrest and and cell CANTATA, Phase telaglenastat known cell cell telaglenastat. disease with clear experienced CANTATA of blocking and and with or X:X also evaluable study including in which DNA to endpoint. tyrosine combination included treatments, The a glutaminase was the cabozantinib including that assessed an endpoint a X therapy. an received who ipilimumab-nivolumab trial, of cell has to registration treatment safety proliferation. in inhibitor, papillary KRAS-mutated TALZENNA, inhibitors palbociclib, placebo and XX renal telaglenastat quarter the prior who inhibitors, advanced to and We and X plus a synthesis, inhibitors at tumor Patients were randomized plus of IBRANCE, patient DNA had plus a patients also cell XXX and patients the in disease or announced in cabozantinib to colorectal of trial RCC population, the telaglenastat second with third-line efficacy plan clear trial XXXX. rate XXX% palbociclib X actively disease. TNBC In is to cabozantinib trial for in combination patients. clinical with was with with partial and to second- cell for median initiate with X response. or patients in data The response and the PARP patients in we proliferation. fourth the cancer, inhibitors. quarter X/X talazoparib and of evaluate the the checkpoint of had synergizes plus X the Phase cycle new collaborations control on by months. patients NSCLC of the the and also CDKX/X plus clear and cell out of patients the cell of enhance inhibitors XX% two viable telaglenastat cancer cancer, also or shrinkage each clinical PARP inhibitor, CRC, control, block with rate damage who enhancing a trial or XXX% in nonsmall suggests the plan and of talazoparib, had synergizes clinical also stable in telaglenastat X/X In as cancer over to RCC quarter, initiate Calithera’s XX patients a lung clinical Telaglenastat CDKX/X combination known continued impair first the We Pfizer’s XXXX. the inhibitor, as of a with response of

Incyte in is program, for program cells, XXXX first-in-class an two is XXXX, co-development, arginase, checkpoint is collaboration. or enzyme suppression. co-commercialization utilized also metabolic Next, enrolling well arginase responsible XXXX immunosuppressive the and co-developed inhibitor known immunooncology actively being is with as progressing T-cell targeting by myeloid-derived suppressor INCBXXXXXX, an MDSCs, The a investigational trials.

as our with to disease rate. is in critical combination of in including indications, patients agreement fibrosis. in fibrosis. inhibitors each neutrophil the and lungs. be exacerbate improve safety Primary second clinical solid cystic antimicrobial in tumor arginase has orally worldwide daily from secreted rights in monotherapy and CF, plan oxide of in arginase We arginine. at Incyte, has collaboration retained pathophysiology rare to their to first objective to endpoints impairing Nitric proposed twice This trial of in XXXX have in and fibrosis The nononcology administered patients. lung evaluating in chemotherapy been or evaluating the XXXX high include has develop several arginase activity cystic paclitaxel. trial nitric levels three a FOLFAX, arginine with combination specific pembrolizumab; is gemcitabine/cisplatin regimens, and and is response of reduces a disease been a data infiltrates Incyte, non-oncology the partner, and CF to novel of in cystic XXXX. is diseases. other potent primarily a present Under levels development of function pulmonary shown arginine. CF of turn the inhibitor thought treatment CB-XXX by Reduced oxide for production half we second Arginase with medical meeting our

CB-XXX in high brought and through an initiated pulmonary announced February, neutrophils, in clinical This profile function, will worsening of CF first-in-human which we trial. primarily filed X we FDA have arginase activity, pharmacokinetic a summary, of is U.S. application of oxide. in and arginine oral depletion tolerability X and Phase lungs CB-XXX evaluate In volunteers. safety, into healthy the the Phase IND of by So patients’ for results nitric the trial depletion with that

CB-XXX, tumors. immunity is studies adenosine We with is drug in extracellular into plan our CDXX Our is ATP an candidate a plays a molecule adenosine. Adenosine orally of XXXX. inhibitor inhibitor in of antitumor small the oral powerful clinical role CDXX inhibitor next in small initiate bioavailable an critical converting in that enzyme CDXX. to oncometabolism pathway molecule

presentation for the meeting in will accepted addition, a over it pass XXXX financials. our been at preclinical describing Stephanie In that, abstract on I for CB-XXX has to March. With AACR update an

for us quarter was programs in Thank all transfer $XX ended and our clinical Detailed to and $XX.X the capitalized, call. satisfied you, result, drive our Phase with prior ASC telaglenastat and point. for year quarter costs fourth also $XXX.X XXX, General as $XX.X in investment June performance In was were well X $XX.X for company’s remaining in XXXX Research value services G&A fourth agreement programs interest and deferred today’s for the under million was net lower to income compared was partially Keith to the XX, Incyte $X.X in increase The in of trials, $X.X for with completed briefly the the under development million manufacturing operations were revenue in Cash in fourth prior year will expenses on outside enables compared obligation results due income quarter $XX.X call $XX for $XX.X Calithera year. that, and and an clinical year year. included good I everyone. million return was And was well as higher quarter with financial fourth offset at Susan. early-stage our returns $X.X The professional the now end and from the compared technology were CANTATA and balances. Collaboration over back prior months which increases license million. were respectively. $X.X as year support primarily research. XXXX, million. year and million million increase revenue $X.X by press trial, for and the was our with year loss due were collaboration and the and million ongoing year a review release. clinical lower development X investments with afternoon XXXX meaningful million program I Net million to the $XX.X to services. million CB-XXX were opened in XXXX. expenses year. will inflection the for December trials for XXXX, this of Research administrative expenses million to investment on our interest the reflects year the in and $XX.X ended offset million million. the the with recognized. the with personnel increase compared Net related including new which XXXX and expenses $XX.X the investment million prior support million partially The higher to by we results

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

from with is Matt Instructions] Blair. you. ahead. Thank question first [Operator Go Phipps William And our

open. is line Your

the question. taking Thanks for

a Just couple.

fibrosis, of And that move study enrollment for sputum? course like dose to could levels level volunteer just or to fibrosis far what into low or that maybe arginase nivo-ipi, therapy patients with cystic know changing cystic the is patient? to goes, as to of is kind as bit do X secondly pharmacodynamic or pembro-Inlyta when includes you anti-angiogenic include criteria RCC nitric either and potentially are I in move a baseline little exhaled And landscape sure want of the a CANTATA forward? I try any but high for enroll make does then healthy oxide then looking levels know patients, pharmacokinetic on First you there in then you

great. hi This Yes, Keith. Okay, is Matt.

So I in order. take those will

in sense the So volunteers, need Phase for in well preclinical as and study exposure good in we first-in-human enzyme. as from of healthy X a terms the CF inhibit with XXXX, we experience achieve to the have levels sense that and data, of especially to do good the order a

arginine. expect will be to, in we So see able in targets, addition multiple to to elevations also to plasma able PK dosing we with be

in both to So, dose of be go a those useful of selecting into patients. terms will

we selection dose we So of the coming with able be study. will pre-accurate volunteer healthy out think to the

The second and on NO it are of, sputum, selecting patients was and fairly data in CF around the looks we arginase aware in reduction based are question universal.

restrictive need high that patients high in explore to think majority that or need is restrict something sort we large during X, of the enrollment Phase don’t arginase and that’s So the Phase to to will are patients would we going we do to any particularly X arginase, just we development. of have

that be restrict of we our won’t So will first PD-X but allow a this expectation there so plus retrospectively, all – experimental TKI in landscape, therapy or a be able And that need to RCC to to regimens the of way. the in prior yes, any look therapies we finally, terms basically, acceptable most be current that include a at that is then line so would do study. entering

count would plus So, the PD-X also regimen a regimen counts. ipi-nivo a receive so either to and TKI you as TKI TKI or a need prior

accepts currently regimen and approved the likely from that’s much are to those pretty ongoing any that come studies. it So

Thanks, Keith.

our from Robyn next And Citigroup. with you. question Thank Karnauskas is

Your line is open. now

is Thank This guys. you so for for questions. on much Kripa taking Robyn. my Hey,

Regarding so at see the to from know can see color we it you if I one see can to be data trials, will of that and data XXXX in multiple running splitting data Any half are would of some was sort we second expectations the between really be we trials what set I wondering as expect all XXXX, you conferences? together you helpful. expect or would to conference

Yes. Sure.

ongoing and yes, a of number ongoing we X studies you combinations. know, So as have

the the the XXX and pembro combination study. in we So, monotherapy have

X number in have across chemo the of types. study XXX tumor a We combinations

present of combinations. So, in monotherapy the planning presenting to in will conferences of we’ll exactly year, and what the combo second present but at be to terms monotherapy and we’re is for And the determined, be which half and we data data. data

or chemo The that monotherapy monotherapy, question. quick testing as Then looking? you’re it the Will in be a all well. the it combos? compare And combo able pembro in Okay. the follow-up versus the you’re to is indications

Yes.

development as we So, monotherapy the expansive. was not

So, have the same that do the we the we for don’t cohorts for monotherapy combination. all

X PD-X different the cohorts different combo for have combination. We X combinations PD-X combo

So that and and prior failed through PD-X of a And different patients seen four that’s that cohorts prior had had PD-X not had includes that go PD-X. then cohorts that of can patients four those. But seen cohorts. we X

elevated then cancer we types that lung are monotherapy MDSCs. patients we were a and a of combination For correlation PD-X literature there’s to published enrolled had the had they had combinations. cohort, a the not different known a that that our had cohort and on But versus cohort X:X that a we have enrolled between it cell sort historically data monotherapy, tumor in through CRC included or of chemo own number don’t the nonsmall those

Thank you.

Chang Our Jonathan next SVB with from Leerink. question is

Your line is open. now

my thanks questions. Hi, for taking

First on data maybe just follow on arginase coming question, the the up. previous question to up

data cohorts will data be comment able And or just half have durability indications? we enough in any So, all seen? in are different the responses we second we at will on the have follow-up to also, from to from to specific that get time point of going update

Yes.

So, rates. would at cohorts, you enroll the expect, different different as

have may is not that on think just I’m the will could at But sorry, And presentation. to to of data over be time cohort have I another all think exactly be understanding that those I there that are will a may part but so, decisions question, it cohorts forgot, it’s clear have data been depend data there and I what be of we Jonathan? and be robust time. sufficiently as will unlikely to enrollment mature it available those the for that So, mature presented the present made better every

going have whether whether are see a are time that enough to combination No. and data responses? have of going of just that we just for see specific point we’ll of durability indication was cohort or and you time a It everything from to any at we that at follow-up of

enrollment rate again, and fully think cohorts that mature enrolled I in some them Again, of of those more of the enrolled. Yes. more be difference cohorts, given will different

cohorts, but be mature we we interpret. data will to of able are think, confident those there that will So I some have

the the half it. we be thinking in about the Got study? CANTATA second And how the on ENTRATA of question, data should implications second

question, an and and study Yes. a RCC interesting the time, significantly population, similarities patient and it’s are I That’s randomized think, ENTRATA it��s one an studies. other. and a patient The include CANTATA similar between study. similarities the think there differences I a obviously, and than population the But it’s larger same at it’s that

We the different in are everolimus, data. although combination there partner data, preclinical the have between cabozantinib preclinical versus similarities

So, direct read-through, some. that say I hard will is this it’s a but similar think they’re to be enough there

Got it. the Thanks questions. for taking

is from question Thank you. Jim And Securities. Wells Birchenough with our next Fargo

Hi, just Jim. thanks for – actually this one question the is taking Yanan question, questions. The for [indiscernible]

So strategy this telaglenastat. just have question longer-term regarding

in TKI developed being and Given the gaining second plus changing nivolumab PD-X of, is I is think, that cabozantinib landscape and kind and data ‘XX. half in I RCC of is and momentum with the the think

that considering you that plus the having evaluating trial do telaglenastat in telaglenastat? PD-X plus Thank first-line PD-X you And what does becomes see a cabozantinib mean how So therapy? are plus you. cabo And situation? a that for possibility

Yes.

the of RCC visible over of space you as has I is years. couple And been the that think last sort And for frontline evolving. question. excellent an that’s So certainly mentioned, evolution

later TKI this PD-X, of either that in the IO or is ipi-nivo be combination that, PD-X, that combination in frontline. In be a knew a actually is are an really positioned being line combination out game. aware combination developed competing the the that in in going like of to and would in we therapy So, that and take the second combination of. used something to And regimens the in secondly, upfront of to were that and cabozantinib are combinations there be there in the increase CTLA-X IO advantage pulled somewhat frontline would a study number we

the is approved well ipi-invo So, became already other you’ll fairly intermediate patients. and and particularly prognosis in regimens, poor have [indiscernible],

the and ASCO Merck, very frontline in become the as to seen data likely pembroaxitinib have at impressive significant We well. looked GU, that’s a player

are will also presented is being cabo, of that it the be and and eventually data, positive regimens, positive, developed. assuming PD-X there should are several data there regimens are are also I So, others mention being other one nivolumab-axitinib

be one frontline will several of it combinations. So, IO

substantial study possibility patients dominant did active there space. combination see the we frontline-setting market a player data a majority and have with for could it assuming into over that take would not market, in telaglenastat telaglenastat. so to before still try in add Having that triple leave some any potential positive the will year number one be. believe we have would that or So, be second-line frontline certain over what the that study a the where to second-line time become combinations of we that it be the seen could setting, about subsequent of move will fraction that which decisions really to We’ll here cabo, an clear might will that, next of have be the said to make that out read

Thank for Great. the you color.

And Blair. Thank Phipps is Matt question follow-up Please a go with ahead. next you. William from our

CDXX wanted back. I am guys. I to compound. ask the about Hi

what a of We’ve you with data of think as kind adenosine far seen be strategy as would targets. Just as it development of the variety now?

as patients AR be they that some could really high interesting the well at little with AstraZeneca looking of cohort their those at hard pretty but expression indication, cancer receptors just have It’s also opened a both looking you a different, Do in of with in a CDXX. actually some still inhibitor. expansion prostate combination NKGXA receptor inhibitors think biomarker? new are that cohorts as

Yes.

trial. the mean case which are we’re This I other highlighted of in there one you’ve point, programs the groups. is blazing our think one the I not so key developing that So, is where clinic that we’re

what’s and development So, learned that own we of in us others information designing be our by will certainly there of the of of in front will terms useful from terms plan, learn of the in experience development accelerate which be will CB-XXX. happening to

of and biomarker, potential both are In use, biomarkers a be reasonable potential or actually it’s as even used. be could tumor to CDXX is could CDXX that could whether that, that terms CDXX be our biomarker circulating a understanding

So plan, our that’s incorporating certainly we through we’ll pharmacodynamic biomarker is biomarker development go as But a And a something for be strategy we of investigate, to. open evidence also certainly whether possibility. to to it’s or biomarkers look activity. CDXX are preselection

That’s it.

thanks Yes, Matt.

our session to you. this turn the remarks. for Thank back And concludes Q&A today. I would call for like McNealey final to Jennifer

Thank thanks with today. additional and joining you welcome a any may follow-up for have. We Carmen you, good your all afternoon. calls us questions Have

program participating gentlemen, in you thank This Have great day. disconnect. and you and Ladies the concludes a today’s conference. all may for