Calithera Biosciences (CALA) 11 Mar 202019 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by and welcome to the Calithera Biosciences Fourth Quarter 2019 Earnings Conference Call. At this time, all participants' lines are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference may be recorded. [Operator Instructions]

to conference like speaker to now Ms. today would hand over the your I McNealey. Jennifer you. Thank ahead go Please ma'am.

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

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

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

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

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

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

over that, Susan. And turn call with to the I'll

cancer biotechnology immune building of the integrated quarter targeting tumor our Jennifer. are XXXX Thanks an pathways joining oncometabolism cell and for that conference we other Good drugs. metabolism for afternoon small everyone and molecule year-end fourth are that At you today on develops and and diseases. treatment us Drugs thank call. novel Calithera, company

candidates, positively towards clinical of patients drive outcomes impact opportunities creating programs pipeline multiple are a we building development novel for and therapeutic commercialization. product By to

into and cancer the We a are first glutaminase clinical demonstrate in first take the patients. clinic activity to company inhibitor selective to the

Oncology, or telaglenastat activity for believe demonstrated carcinoma, at XXXX, September European ESMO cell cell Medical we compelling which for renal the carcinoma. in meeting trial we the of the the on Society in we presented results in for Based ENTRATA have advanced renal proof-of-concept

telaglenastat biotechnology with renal fully We commercial step moves becoming the to a This cell have closer us enrolled trial, potential now company. registration a a carcinoma in CANTATA patients. study

with are enrollment to the are of CANTATA helped goal. schedule who ahead We and exceed of patients the our pleased grateful and investigators us enrollment

to We are, outbreak and related of Calithera potential developments specifically closely impact its the course, the CANTATA the monitoring and trial. on coronavirus

for our interruptions time said, year. the third quarter patients. major remain know treatment it trial. line our it line impact or quarter know, we what clinical As is to top meet determine our on CANTATA of making confident data we But in for difficult we Based we fourth can this you that situation a not exact late do anticipate conduct of fluid today, the any or the challenges on

population. And This this XXXX. the results that clinical data are quarter mutations cell first-line first initiate trial activation the trial in a interim that lung we this in we of also Recent potential year a in the poor significant indicates cancer genetic data KEAP. non-small made progress in harboring nerve or NRF/KEAP towards initiating in a very pathway patients randomized in of unmet clinical track demonstrating outcomes, on remains with need for there to half

activity presented enzyme inhibitor At tumor clinic. cancer. expressed the the efficacy the ESMO arginase the meeting for data is of were September for arginase XXXX, proof-of-concept microenvironment. immune to is providing Arginase treatment Our compound demonstrating or enter in inhibition INCBXXXXXX first inhibitor this arginase the cells first for and XXXX in by immunosuppressive the an

first-in-class we tumors. seek of this product progress develop with to of the patients solid We multiple are pleased for as a with program types

of treatment in wholly-owned is of our X start we cystic year. trial a enrollment for completed fibrosis. track with patients first on the Phase with A trial arginase fibrosis cystic in healthy for year, volunteers the inhibitor half to Phase in the Last Xb CB-XXX people

Beyond remain focused candidates in potential differentiated producing our the drug and with of three clinical-stage areas on programs, We highly R&D a need. team. a to be novel broad we new have pipeline therapies unmet productive

Our immuno-oncology. preclinical-stage program most are advanced in

development in Meanwhile, continuing preclinical oral advance molecule we inhibitor have tumor studies with immunosuppression. program we of promising plans with We preclinical to not this involved our target chosen data a molecule inhibitor but to and CB-XXX time clinical our have trials at do we CB-XXX, CDXX, small are have this year. this small ILXIX, novel deprioritize into of

call the pass details programs. will additional on for I our that clinical with over to Keith And

Thank you, Susan.

of Let's update candidate. and begin our inhibitor glutaminase with detailed product a our advanced telaglenastat more most

clinical We are renal focused telaglenastat commercial carcinoma. potentially forging and cell a in for on path currently

the in third-line patients significant we unmet advanced a enrollment for and of third-line global trial of the need double-blind schedule In enrolled setting. cabozantinib quarter, patients. second RCC and RCC combination completion the of in in of randomized XXX patients telaglenastat ahead demonstrating announced with second CANTATA, CANTATA

is the prior RCC in of one cell plus patients or of therapy one lines to including safety prior efficacy the ipilimumab/nivolumab combination. CANTATA and clear in versus have with or who combination designed placebo cabozantinib anti-angiogenic two agent cabozantinib at evaluate received least telaglenastat previously

with assessed endpoint cabozantinib. cabozantinib IMDC The ratio anti-PD-X be plus in plus risk key treatment endpoint. a randomized will therapy. either category Overall Patients X:X independent as is review. and or a prior were survival to secondary survival Patients primary PD-LX by placebo were progression-free stratified telaglenastat by

we XXXX. trial top and The fourth remain registrational third CANTATA report intent results designed on-track to line of is quarter late in or with quarter

potential the in We also believe mutations. developed has patients NRFX/KEAPX to be with telaglenastat

a preclinical of formation models or tumor mutations pathway gain loss activation KEAPX of mutation spread. a accelerates through that function of this NRFX demonstrated have function and vivo in Multiple

makes telaglenastat. or of activation is trial KEAPX the addition sensitive by in more solid making activity In to currently with the tumors ongoing. that NRFX have single-agent also telaglenastat NCI-sponsored models tumor inhibition them mutations to aggressive the NRFX/KEAPX glutaminase An pathway evaluating of patients

a pathway outcomes in poor chemo-immunotherapy. of cancer to very need Recently presented lung results patients XXXX. in non-small and the clinical cancer population, in of or activation cell randomized care data presented of standard receiving begin expect data designed front-line of lung half have have this we unmet demonstrated the patients we which first Based in KEAPX/NRFX recently that chemotherapy the trial on these

study set survival. will cancer endpoints evaluate KEAPX safety mutations will analysis The An XXXX. XXX either telaglenastat that in The run-in approximately harbor pembro combination of with standard is chemo period. an interim with plus lung And therapy tumors NRFX. progression-free initial and investigator are in in metastatic, or study include planned safety in non-squamous co-primary care first-line patients

an in checkpoint inhibitor INCBXXXXXX program immuno-oncology, known immunosuppressive myeloid-derived metabolic arginase, enzyme to an or XXXX by is investigational Next cells first-in-class block as also activation tumors. suppressor arginase T-cell MDSCs targeting the secreted

different being cohorts pembrolizumab locally is in with XXXX of with a patients combination to across XXXX as advanced of not monotherapy co-commercialization therapy. in metastatic co-development being developed collaboration. as or eight is cancers as with insight types evaluated well local amenable

study data at first XXXX. September from The in presented ESMO this were

of cancer A find three the Phase basket with II dose monotherapy tumors. colorectal cohorts; in followed lung escalation dose recommended cancer, to was cell solid the of by non-small arm and XXXX expansion

and four of in combination that cohorts PD-X populations enrolled XXXX four naive refractory. were a with were enrolled expanded, escalation PD-X Following patient were patient eight populations that dose pembro,

active patients failing disease entry study and the progression had at checkpoint to time which drive refractory of that benefit PD-X or a response. to had therapy they prolonged be means without on disease inhibitor-based a stable

neck and head The Simon The and at presented enrolling. MSS PD-X colorectal to cohort data also and naive ESMO. and actively combo colorectal advanced is both PD-LX monotherapy two combo advanced has on cohort stage cohorts X stage cohorts to were --

colorectal both monotherapy were at focus the the combination were and the were cohorts. As cutoff of data in the the presentation. of the most observed Responses cohorts mature time they

also occurring in total intratumoral with in cells pleased this XXXX MSS derive with to most notably clinical the patients cancer. We with the those that cancer were concept We treatment inhibition in of arginase among following see CDX-positive benefit. provides increases proof treatment believe colorectal patients of for pembrolizumab increases

patients regimens or alone gastroesophageal treating ovarian, evaluating cancers. biliary and is A three trial combination with clinical is ongoing. plus also chemotherapy daratumumab colorectal, endometrial, with second in ongoing An different gemcitabine/cisplatin patients, myeloma and multiple trial paclitaxel XXXX FOLFOX, XXXX in daratumumab in patients additional with tract

with progress to this in additional of updates and program program look the the forward from we We XXXX data are the pleased future.

fibrosis. is We rights agreement collaboration disease are develop as the also in Arginase novel arginase outside treatment CB-XXX in developing inhibitor has play our non-oncology role specific several a worldwide arginase of to development an the of cystic oncology. cystic fibrosis posited we been a in of diseases. other non-oncology arginase of retain well to Under including inhibitor fibrosis. with cystic Incyte, pathophysiology indications as critical inhibitors rare

levels and to function high NO neutrophil have normal which NO, Nitric these depletes lungs, in trials. oxide administered patients, arginase CF proof-of-concept improve patients of arginase depletes High oxide. that concept their exogenous levels can is been We and secrete infiltrates arginine, when CF supported to by hypothesize restore activity function turn potent inhibition arginine has in patients. in CB-XXX improve arginase. with previous neutrophils antimicrobial a and of lung lung NO activity that shown clinical nitric and or has CF

placebo days. compared Patients evaluated. XXXX CB-XXX sputum enrollment which CB-XXX safe determine for range function, CFTR pharmacokinetic to A CF The multiple test adult CF XX will trial to will Phase be first has safety, I doses for Lung study. in in status Phase evaluate clinical dose NO half profile XX eligible clinical Patients healthy with CB-XXX. to oral Ib approximately placebo of will patients, production for tolerability receive and completed. of been any trial and the in to or microbes the expected successfully CB-XXX will volunteers of patients start in is be a mutational

expansion dose-finding order different cohorts in additional of select days patients A receive doses the or which placebo the of CB-XXX. for planned is of will optimal in to dose XX of CB-XXX study

XXXX. continue CF modulators. therapies their from the existing study this -- for CFTR entire We including patients in to existing For plan data trial present CF will

over an to With our Stephanie update on for financials. that, I'll pass it

quarter I good you, XXXX on and briefly will were call. Detailed review this press the results and included Thank our for everyone. Keith, year-end release. afternoon today's results in financial fourth

year Calithera capitalized. well ended the

to utilize at our programs we million points. meaningful expect Our in cash our $XX million and XX, clinical investments to $XX value us to We were XXXX $XXX.X drive inflection enables million December to cash position XXXX. and believe

And last we to the enrollment quarter period program, same for CANTATA expenses $XX $XX.X and were was to were XXXX. Research including for primarily $XX.X our development telaglenastat to million in increase $XX.X in the completed million in program in in XXXX fourth the development The year. XXXX research expenses for XXXX million in million our and XXXX. where compared XXXX trial XXXX compared

accounting XXXX to was were General related professional and $XX.X million compared and administrative legal expenses to $XX.X in higher for XXXX. services higher personnel-related for primarily costs, for XXXX mainly million XXXX to $X.X $X.X administrative increase million last The expenses and costs, million was in period the and fourth services to from the higher year. same XXXX from primarily headcount. General compared quarter

XXXX. Interest quarter in XX, XXXX for income and and other compared with of million Interest the was million. $X was fourth ended million was Net and the $X.X quarter for XXXX other net loss for XXXX XXXX $X.X $XX.X ended in December income million. quarter the -- net

to And that, the return now will call Susan. with over back I

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

Mohit comes Bansal [Operator question Citi. first Instructions] from Our with

is now line open. Your

liquid NRFX/KEAPX the question Hi, I to binary the biopsy the had James it I Are Mohit. is the in output? for a sort positive/negative activation? circulating trial of actually is results This there guess [ph] can levels and output identify of to about Or is tumor for or cells? the on biopsy limited track amount help just some patients. of the lung NRFX/KEAPX guess guys. that just NRFX/KEAPX changes I quantitative

great James, Hi, question. Yes.

on So a binary or -- outcome on it's no these just results not assay. the

just results the of to about levels will it that of DNA samples the what across look the get number taking allow will result. to panel. we response. following talking us study we'll in for genes be But all potential free other all you're a be mutation first So quantitative would circulating do during following or also And status for the a

about a talk can Awesome. closer I a some being strategies being telaglenastat talked for And – commercial one guys you It – step then guess, company. question. but quick or being just one a bit around second to like about of planning step maybe But the early early, RCC? you

to starting in for been put place commercialization? potential For whole plan launch. We've a a

know, status. we you track have As fast

of time for And lines, again so we've on potential move top data a we top submitting they if whole top priority we lot some prior set results, positive, a are were with of and filing the precommercial activities seeing CANTATA the after at an more company of NDA, activities. occur positive. line And to would course, been line as we started review. but those for and towards will see line the them results And have readying

Thanks, Awesome. guys.

Thank you.

next with Our SVB Jonathan Leerink. question comes Chang from

is now open. line Your

Hi. Thanks question. for taking my

around First It guidance on coronavirus-related. late second it's question, you've to the line? sounded your XQ like Any to from color slightly granular not time previously. more half CANTATA refined readout XQ the

No that's to fact – the can as tighten guidance it's essentially. we able mature, really the data, our get that, data up just analyze the as – we we're

allows accurately. event So on terms it's in based a just rates to of and what really seen more little we've us project

it. Got

what the should and on cancer your of Second you interim the XXXX? the enrollment for data about lung Can study. regarding expect nature question in talk investors expectations

so of to given – that accelerate subset operationalize and the a we're of enrollment a the few and enrollment, we're setting, taken frontline include have a terms looking XX% non-squamous order efforts patients in to our of enrollment that the proportion, meant patients. to in the to where specific things at significant In of which is – study study, we optimize patients open are the

population, significant but it's enroll those positively. patients So screen to a and screen only need we obviously, that still then

also we basis all into this a sites a starting attractive, facilitate timely available patients that their order prior line make on So put we in to to to screen to finding therapy. patients for will study purposes, liquid to these those front biopsy place make just and

this one key we're making that's liquid that, So the is biopsy – element available.

a be are in Secondly, significant patients. open order able sites to going we of number identify to to these

opening and at for of identifying aggressively rapid pace. keeping sites enrollment purposes are we the So a

there we run-in safety So mentioned. is an as initial

safe, half it will allow will So we've the to is it us be. regimen go in to to – When And enrollment. to would that going get an patients, from is be XXXX. of patients, demonstrated the it's will a interim enrollment be and open we'll that approximately the The we to able be under expectation until, interim full expect expect bit be analysis, we of do is which that will our then half which analysis, on patients. have results little those that we

should XXXX? position, be about any it. color your how Got burn on And runway then on just and lastly cash thinking in we

but million really to don't We Jonathan. Sure, runway, guidance million. cash this guide $XX year to is $XX cash our

ended year so of year $XXX And we at the end million the XXXX yeah.

Thank you.

Thank you.

Swayam Our with next Ramakanth H.C. question Wainwright. comes from

Your line is now open.

questions. A Good afternoon, of quick ladies. couple

In run for data data was to would what little interesting in is take terms study Keith the sort of us the being study NCI-sponsored what And conducted? you anything this cancers expectations? indications is referring give look over if bit of And on Calithera of could to color and positive, that a them?

Yeah.

patients But a So couple and at it's the is actually by mutations. looking of identifying mutations key not limited that's study their of two these are with histology. NRFX/KEAPX mutations this a different specific

that patients as solid others mean, documented a I So with solid – few as open tumors NRFX/KEAPX solid in mutations well have it's to well. as essentially –

could And signal-seeking tumor we with So, conceivably that patients support types those really It's it's in any with not with as where potentially by development approach provide it specific study be that mutations. data tissue-agnostic be that standard us or restricted combinations even look type. would of would a in monotherapy these or therapies. for tumor a could in

expectations on here? And that Okay. you have anything the in data

difficult the predict to timing. It's

completely and a program. CTEP line. run great the we've -- read -- And independently reviewing this their on we've partner -- study from but reviewed with they've least the time the it's obviously, is So, they protocol, along at been been moving

that. can't really speak we So, to

can Okay. And to you some color next from Incyte give on then we on as update us expect the XXXX, when could this?

myeloma also Actually enroll. All continues. the studies with there's those then chemo which that study our and combination there's have study -- is patients. they study these XXX continue study, their multiple a in So, studies pembro, Japanese studies and the to study, study

of collaboration, Given of that joint that. to we that joint this in agreement absence sort a is guidance development provide our the able aren't on

that. at point, color not no, So, on provide able to this we're further

of Okay. Susan target just after not really going of -- are strategic companies question. few the their through studies and they're When folks. the a most guess a CDXX these I quite Phase as a hardly X

So, what's Is the with deprioritize reason for CB-XXX? you to science? do to that it Or do is something resources? to with something

the It have science. to anything with do doesn't

selective a inhibits compound that have CDXX. and oral We really potent

with happy data preclinical toxicology and on the quite data we're So, molecule. we've the generated

pointing one not to which being data the targets as studies types Right multiple way pathway across and now do tumor with adenosine what would definitive to the CDXX entire in just no interrogated should in also broad. not with be would order the and be only to ahead who path but other competitive landscape we quite move are us, molecules of forward in companies a have combination

to we're open of now had own clinical to other resources lot our us. in if would clinic from we going that right partner so we other like we help have on our into still But concept And pursue. the a on to the of programs priorities a

Thank you. Appreciate that questions. all Thank you my for taking Susan.

you. Thank

you. Thank

comes next from Our William with Blair. Phipps question Matt

now open. Your line is

mean I standard patients of Hi, so see this you how here with first these this cancer anything thanks know give do did trial, about -- on we much benefit us care? taking the considering care guess, can need how my Keith, lung is on is standard for top you questions. powered? how poorly to I that

PD-X off and were if a -- I was non-small call update ton patients. -- just see had they then of rescue there's cancer if a it you of had go guess cell I don't of the And back anything the think then go the in They them lung mutations were previous in was there see any of look patients some previously trial there those patients you been this study. can NRFX/KEAPX of. and and any that

Right.

study XXX so patients. it's of terms in the So, design,

you have the for quite mentioned, been outcomes core. As based data that these on presented recently patients is

with study, increase. think Phase study. We isn't also we'll but even a small which huge a see not XXX X. like able it's So, reasonable not It's powered a patients to be a

here a Having X.XX. design. not said about for alpha of that So, we're like two-sided -- talking the

with a would source. talking Having be statistics then you increase said in that, that benefit, interesting about of significant

so to study that signal. be would be So, we've tried sized see reasonable a But to able run would enough also design home large a of we the interest.

So, two-month that would move subsequent better us randomized or a into a benefit give to evidence study. forward

Got it. lung previous observation? And Telaglenastat then anything on those

Right.

So, yes, activated patients so through study mutations. did the have we on that that has pathway

certainly with We we're haven't study. as as the will point forward I but of present plan plan presented at the And of them some data to those part and think our go were thinking those be aware publicly, we well. data to current

Great. Thanks.

slide new these patients didn't maybe of cell have appear trying why that you the have to watch want you aren't. of you're cancer a those guys responsive? of are one response? mutant maybe recently to those mutations. experiments very will have a a looked lines responsive. couple be assume another -- if cell lung primarily there's at You cell lot as I to in some There's out as predictor for cell that And not There's lines wondering be that cell these lines. a most tease on I -- just multiple that deck But lines kind shown patients could out that guess some have has see KEAPX if preclinical the mutation and

that, of -- the but think was not line as well cell it when of as sensitive haven't a cell pathway that one for work we on analyzed we did activation So least the it lot that activate I other seen lines. the have done

does didn't it the through gene did So itself it expression It to it harbor while act the -- show and mutation. activated profile didn't fully have its pathway.

probably that's think much we say there. can as as about I

you have else to anything I don't know add. if Susan

of be And gene see the really patients true. the that mutational at add expression and looking be patients not through those looking status No were of will profile pathways would study, also not. or actual and I the of at our to as we'll we on able that's part biopsies whether just

know So they it's many where pathway lines that's just carry able mutation activating will knew that We specifically yet the an and know one had be We to studies. patients line. in example lines, we mutation don't pathway. activate activate across they that cell delineate we didn't cell rare that why out in the but cell any didn't the the our but of clinical

expression for genes, be may That could these immunochemistry gene or yeah. be some that Yeah. of profiles

questions. Thanks right, for taking All so the much great.

Yeah. Thanks, Matt.

you. Thank

comes from Securities. Birchenough Jim Wells question next Our Fargo with

now is line open. Your

Good afternoon, it's Nick this afternoon. for in Jim

protocol trial Just telaglenastat. following excludes up know I on for who have actionable patients mutations. the the lung cancer

what on actionable in you XX% can that So just of activated talk a to pathway patients overlap pXX of of between interest? mutation the have the about is mutations KRAS

Yeah sure.

KEAP not is there actionable have do So of patients activated, the most so have -- a who mutations.

So rate there's sort of they're a exclusive not KEAP ALK of EGFR actionable in but mutant mutually there's reduced type -- patients. the mutations

less common while to patients actionable have mutant overlap, it's mutations. you find will among the So KEAP

And then I'm mutations. think overlap, Susan the correct if I KEAP the -- have of mutations KRAS/KEAP terms one-third but think also KRAS me around wrong, of about I in

have there. majority KRAS but looks proportion do. there definitely it a not overlap of is patients do like So the significant actually But

preclinical equally to cells is telaglenastat? or present the then are suggests the And data Okay. KRAS not, whether that sensitive those

Yes.

on – in there's is there's necessary. take outcomes are data KRAS-dependent. data different and the then clinical the from that. not models that opinions that KRAS So different it general preclinical there's our different some – is But the suggest are not And on

– So poor to mutant have be have to outcomes. KRAS don't you

in terms our So response on is not inhibition. it's the to that not is of problem glutaminase take a of data the likelihood necessary also KRAS but

be you for I that Or the to stratified patients LKB. it XX% account expect then to these based Would are of or STKX And be going will think Okay. on small a patients? fraction?

It's more as to significant if to a third the are And where probably you of stratify. in the to It Yes. range proportion. mutant. be patients it's to – range stratify. want is that do more trying The X%, actually a range in XX% a important or likely if it's STKXX KRAS. around remember. I'm intermediate that relevant you're same it's when might it's that's be STKXX/LKB a it's not – to But

just then study. one last lung And this on the

the analysis. interim about talked you So

profound see you essentially have have do do opportunity you this If study? think you'd benefit, the you a registration or the study start close expand a study to for to brand-new purposes and

Yes.

are – So we there would that think all possible. those are options

So study do that will we either study. We amend specific or with talk to screened FDA get or their new we at could something would a a could open patients this through and think Most even assay by. just new input. amend would for is study. select we we the all likely be conceivably screen a that current point likely do But

me. then one And Sure. just for last

telaglenastat we data the combinations, IBRANCE this For some expansions? a and safety of cohort expect should efficacy year or ahead

escalation – through studies They through are their mean I those dose – expansions. into the ongoing. Yes. are getting and so

presentation. So we haven't guided around data on specifically timing

it So I this year. this but would point be impossible say, at data to the not doing presentation definitely guiding wouldn't of a we're definitely

And Great. Thank very unfortunately. this at much. each miss you other – I'll year we'll AACR

I guess so. Yes

Yes.

time. remarks. any back Jennifer not questions over further call Thank at closing now McNealey I any to turn would for like you. showing this the I'm to

all to thanks great joining Daniel. Thank evening. a you, And us have and for

this call. conference concludes today's gentlemen, Thank for and participating. Ladies you

You may now disconnect.