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CALA Calithera Biosciences

Participants
Jennifer McNealey Vice President of Investor Relations and Strategy
Susan Molineaux Founder, President, Chief Executive Officer
Keith Orford Chief Medical Officer
Stephanie Wong Senior Vice President of Finance and Secretary
John Barrett SVB Leerink
Matt Phipps William Blair
Call transcript
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Operator

Hello and welcome to the Calithera Biosciences Q1 2019 earnings conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions]. I would now like to introduce your host for today's call, Jennifer McNealey.

begin. may You

Jennifer McNealey

Good XXXX Tonda. Welcome our to Thank call. afternoon quarter conference first you everyone.

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

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

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

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

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

Susan Molineaux

afternoon we outcomes This programs oncometabolism and we tumor molecule multiple in year. the to commercialization. cell development data building quarter, small are year, an data other with Thanks product that into joining stage pipeline cancer to including novel In data ENTRATA first diseases. programs, advancing creating us and company partner clinic you pathways the At have of Calithera, the to develops Incyte, towards XXXX By drugs we year-end. opportunities good treatment Thank midyear the candidates, expect novel and a strides the clinical Jennifer today clinical and second of quarter drive the are for of for impact results and immune is cystic on trial program building program therapeutic positively patients metabolism integrated presenting everyone. in for call. our program our are on key which in also our conference our first drug, of XXXX topline our that targeting half clinic the milestones multiple and from by enter several development readouts, preclinical achieve made we the our earlier great inhibitor, CDXX poised have fibrosis biotechnology and

treatment for the cell to for combination of program enrollment continue of late-stage RCC. placebo patients earlier ENTRATA CB-XXX carcinoma We of treatment RCC. of also in telaglenastat trial everolimus comparing versus we randomized parallel, the as our studies or renal advance RCC. plus stage completed known the And everolimus We with conducting for telaglenastat, outside plus clinical the are of

We to broadened new earlier-stage telaglenastat our cabozantinib and randomized versus trial we also clinical for placebo in And with enroll combination clinical CANTATA telaglenastat to Pfizer. cabozantinib collaborations with continue RCC. global patients program trial of two comparing development plus our the

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

Our entering both XXXX. are in molecule novel two discovered development drug new internally clinical small candidates

of oral cancer. the second cystic first small And is the study. the CB-XXX, in of arginase treatment is for is an for The oral inhibitor one molecule inhibitor already X CDXX an treatment which Phase one fibrosis, CB-XXX,

forward important a move look in programs in of forward milestones our As XXXX. we to development, number

approximately X randomized we year-end. trial report and a ENTRATA is fully patients For to we trial, the data by CANTATA mid-XXXX trial expect in XXX topline plan to telaglenastat, and with also enrolled the enroll Phase

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

of scientific Phase there forward CB-XXX. over We XXXX a I X initiating pass this is describing an And presented of programs. goal to data updates our the increasing in among program. abstract And believe first to we additional achieved with AACR CB-XXX, quarter expect we and the preclinical initiate for trial trial look at the CB-XXX, For X call to on will community interest XXXX. Keith the on in adenosine that, and for update a clinical Phase pathway in

Keith Orford

Susan. you Thank

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

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

with of X/X synthesis, clinical of cancer and glutaminase CANTATA cell plus approximately DNA placebo-controlled enhance telaglenastat DNA combination and actively in and the therapy, cabozantinib received lines we a to in are cabozantinib previously initiated second who of last will block of cell provides impair to global XX trial and clear CANTATA GU which trial of February with meeting announced efficacy Late enrolling for patients cycle patients talazoparib year, third patients. by potential. in key Telaglenastat cabozantinib. two regardless trial. in either placebo recently evaluate plus tumors believe risk among one category collaborations of new patients We telaglenastat demonstrated We response XXX is scientific or proliferation. in rate XX% plus we have treatment in a strong with the by in has least rationale synergizes in independent enhancing combination clinical also clear potential to The and designed telaglenastat trial to with assessed our nivolumab cell to data cabozantinib Overall a combination. ratio synergizes suggest combination primary or at PARP sensitize endpoint BRCA Ibrance blocking RCC RCC Pfizer's randomized proliferation. also stratified Patients cell oral being X:X antiangiogenic plus survival is inhibitors with by evaluate two prior to at We presentation also patients PD-LX trial damage that patients telaglenastat. review. talazoparib or ASCO evaluate the agent with telaglenastat including a the line endpoint. anti-PDX, ipilimumab, RCC as and in inhibitor Talzenna, with prior versus prior the known and also inhibitor, PARP mutations trial inhibitor The Preclinical be one telaglenastat safety Calithera's cabozantinib CDKX/X cell will gene. cancer as registration survival secondary in combination arrest CANTATA, as in telaglenastat placebo free TNBC. know is IMDC randomized the the CDKX/X Phase therapy. It the are talazoparib, inhibitors be each a of XXXX will progression and palbociclib, a Patients in

KRAS-mutated Phase colorectal initiate and X/X plus to This quarter, non-small combination lung clinical a with cancer or plan cancer or NSCLC. we CRC telaglenastat of of patients the in patients with KRAS-mutated trial cell palbociclib

is Incyte arginase as is secreted the arginase, immunooncology activation inhibitor tumors. is by an enrolling immunosuppressive XXXX a also with progressing derived T-cell cells MDSCs collaboration. Next, first-in class to checkpoint targeting investigational metabolic and in program, INCBXXXXXX, The well is two codevelopment, XXXX myeloid suppressor being cocommercialization trials. in XXXX, program developed actively block known or an enzyme

in trial monotherapy evaluating XXXX as first a with pembrolizumab. is The and combination

worldwide have is human gemcitabine lung the partner solid has we three when several In been initiated evaluating data a lungs is for cystic half FDA these Arginase clinical in Phase which is can Primary arginine XXXX. treatment inhibitor depletes we activity oxide arginase to infiltrates High CF of and develop a diseases. and in oral in and rare or cystic NO and retain depletes antimicrobial with the potent response trial, plan the plan inhibitors the CB-XXX arginase development nononcology function chemotherapy novel an February, of The arginase. have regimens, other neutrophil fibrosis. trial. neutrophil and that to oxide. has hypothesized present announced rights volunteers. CB-XXX fibrosis. activity is first evaluating normal arginase and profile FOLFOX, medical Incyte and safety second levels NO, arginase disease in of their and in function be tolerability to in pharmacokinetic pathophysiology X patients. Incyte, with combination CB-XXX the tumor with we second lung complete include year, specific of filed in nononcology each Under restore application we improve this levels CF our healthy of objective agreement XXXX This We collaboration to at to IND fibrosis We of cystic Nitric rate. X with paclitaxel. in improve to in arginine including been in for or CB-XXX a patients meeting nitric U.S. high our indications, patients. critical safety, Phase proposed that secrete inhibition which CF of turn and to known administered cisplatin trial endpoints shown

in CB-XXX, single by CB-XXX pathway. CDXX, CDXX molecule has adenosine oral the CB-XXX, extracellular immune inhibitor activation Our ATP inhibitor converting into orally an enzyme next of both small drug oncometabolism agent combination an Stephanie chemotherapy adenosine. candidate, of immunosuppressive bioavailable on models. We I a activity CDXX suppresses potent, an over our clinical plan in in to pass and and animal activity initiate to with financials. standard And preclinical will it with that, studies for with update anti-PDX XXXX. in

Stephanie Wong

of Detailed good everyone. well the us today's XXXX the afternoon Calithera review results briefly I on financial in increase call. programs trial, this related ended and quarter CB-XXX were call to enables expenses G&A And which program, and $X.X our will $X.X million I quarter for an costs meaningful higher March $X.X capitalized, will year. release. of XXXX. Keith million well our with the Net million increase clinical were CANTATA for the the drive you to quarter due million included Phase press R&D Cash first the $X.X primarily was from return as early-stage now for of including an Thank million that, million million $XXX the $XX.X point. million million increase increase loss to of were the $X.X compared million increase value with program were compared prior to XX, research. March million back personnel The months our for services in was in inflection quarter a per investments operations XXXX expenses related The program, as three prior to or at X cost. $X.X year. with in telaglenastat in XXXX investment over $XX.X Susan. was $XX.X ended professional share. XX, $X.XX the and results $X.X

Susan Molineaux

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

Operator

Instructions]. [Operator

Leerink. comes from the with SVB Chang question of first Jonathan Our line

line Your is open.

John Barrett

Barrett, This updated Jonathan. for additional John the Could color you timing on Hello. provide any ENTRATA? for is on

Keith Orford

Sure. Yes.

which have updated we is timing further just guidance. we So guidance information, able the original our noticed, mid-XXXX, we really, to given are more as are along, down that that to narrow from have have we you

really guidance. of significant narrowing the no just a So change,

John Barrett

Got you.

that about data question now the implications thinking mid-XXXX of how the Second ENTRATA is, expecting you study? we on in should CANTATA be are

Keith Orford

Right.

patients. have So data ENTRATA, will randomized study And also randomized as we with you it's be It randomized everolimus. in a our RCC in our study, combination is CANTATA And mentioned, as RCC. study. know, first first is in

So it two. and in RCC the are will be our there similarities differences between patients. are There first data

of is different -- preclinical suggests similar that the a of is in obviously terms the yes, design obvious, patient therapy direct synergy of enough that have I population study of leave it and line will We not mechanisms but read-through data there. but

John Barrett

more, in some announcements One space? are How the about thinking if competitors data adenosine may. Thanks landscape, post recent Great. you the I the from the color. for

Keith Orford

Yes.

receptor So in at prostate AXA the cancer data inhibitors for there encouraging and AACR, some space. particularly was

for considerable we and very saw and we adenosine the and think maintain our as So the rest we pathway. that positive mechanism for the enthusiasm the of for the field enthusiasm pathway maintains

John Barrett

questions Great. Thanks and for good answering luck. my

Keith Orford

you. Thank

Operator

you. Thank

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

open. is line Your

Matt Phipps

questions. my taking for Thanks afternoon. Good Hi.

Just that different not to inhibitors? And as up not prostate bit. AXA as we where activity development then think on be specifically where to expression Is cell try tumor cancer far or there seen inhibition have adenosine monotherapy you to correlated you types would of accelerate follow this somehow the renal in as something think the is responses far or a receptors little go? any seeing CDXX with reason would or the maybe would AXA

Keith Orford

Yes.

think I our part are us. be of the first-in-class I that the So we of folks learn guess it the, are able to would being definitely, not of that from here benefit in front is

So can front from molecule can that's orally us. pathway and of best-in-class that the provide in of continuous think we are we have and we a inhibition bioavailable learn those

lot in would in development through terms us. are front following But to expect up a of between XXX% from So terms where differences of pathway to absolutely is be to be CDXX them, be that inhibition, to then that in and other see expect AXA we that overlap to expect correlation between can't receptor there on. likely activity able we of of we efficiency there in assume And programs of learning the we the but would see worth one certainly increase activity.

Matt Phipps

Thanks receptors? you of benefit an There Keith. think And by AXA inhibiting there then ongoing. and number those the both a trials additionally, combination CDXX is is do added

Keith Orford

Yes.

may that of diversity of utility I that can inhibitors in full there on pathway twice the characteristics there inhibition. hitting I given particularly rationale, certainly sort that that. think see be of a exist, pathway to ensure is opinions of the some the

that the other make could more vertically. might a or On pathway potent that one hand, active hit a unnecessary more imagine molecule maybe to it

remains there at consensus approaches it's a inhibition, still is sponsors' different or around based debated isn't point. So vertical that open can that see, question and I being and certainly think we an one on to this uniformity still

Matt Phipps

Yes. Got it.

we you healthy as Okay. PKPD How And or on biomarker And year are get CF then are from trial lastly, for planning going, the these patient you year? CB-XXX, this data the do initiating this well? trials? volunteers quickly

Keith Orford

Yes.

levels given know, exactly you timing the of escalation, know nail is with down play As you will the dose planned, certain the we number out. how to that have hard dose but precisely, timing never

So PK certainly we data. to able some to will year. get study And amount we to do have access that to PD expect be completed and this of

noted that in different PD, think population from going I healthy to it a just volunteer should be population. PD patient is

the So we see clear of that data. interpretation is, we will what see when we generate

to the In expect year terms timelines, this complete to study and patient after. of plan we again the the forward soon with that study think then move be I do would

Matt Phipps

structure, cycle, exactly get something other sorry, it far disruption where to the from And actually to try you urea cycle your as to then dosing it arginase to as dose, was, is for look going remember can't program? I recommended I am what

Keith Orford

orotic The yes. Yes. acid,

Matt Phipps

Yes. That's I think. it,

Keith Orford

Yes.

that. will certainly monitoring be We

that elevation are we sign plan cycle, the urea to reason do urea see follow of a extent, that well inhibition that a although and the significant you it clinically some early can starting we very the As to following dose But inform well orotic selection on is cycle. we that would that is impact as acid before yes. know, to

Matt Phipps

All good And right. Thanks. luck. Great.

Keith Orford

Thanks Matt.

Operator

McNealey Jennifer I over I the questions am turn at now like would this for to to no call remarks. time. back further showing closing

Jennifer McNealey

and Thank have thanks a joining good you and all us Tonda for today evening.

Operator

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

have You now may wonderful day. Everyone disconnect. a