Calithera Biosciences (CALA) 7 Aug 182018 Q2 Earnings call transcript

Good day, ladies and gentlemen and welcome to the Second Quarter 2018 Calithera Biosciences Inc. 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] As a reminder, this conference call may be recorded. to host like Ms. today's now would introduce for your conference I McNealey, Relations. Investor President Jennifer of Vice Ma'am, begin. you may

Thank you, Joel. second quarter Good afternoon, everyone. conference Welcome call. XXXX to our

Stephanie our Joining through Keith and our be press Vice Development. calithera.com. President Susan release today Clinical Senior Vice Molineaux, website of issued me and of at are Orford, CEO; accessed We've Wong, President Finance; and Senior President could Founder, a it

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

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

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

clinical and a metabolism continue that our molecule you everyone, pipeline company of development to Drugs other entering In the our we building for biotechnology XXXX opportunities on with cancer thank outcomes two an second for building us are the drugs. candidates, pipeline are development. small glutaminase By our inhibitor targeting programs of cell afternoon, of call. quarter, onco-metabolism patients plans inhibitor each develops the impact second Good and we pathways programs, of conference multiple clinical product novel and novel we are novel our that Jennifer. to diseases. treatment Calithera, Thanks, candidates for deepening quarter joining clinical towards immune and arginase and our At creating drive positively tumor execute development therapeutic today for clinical commercialization. while integrated

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

to announce pleased are that clinical new advanced into two programs We internally we've today development. developed

half drug, clinical bioavailable to of and with CF nitric in has of patients critical First, inhibitors we level fibrosis rights correlates high in we development and first with trial function investigational several indications, scientific this with CB-XXX the pathophysiology our CF their bronchial by CB-XXX from and arginase, CB-XXX, levels fibrosis. patients is been in treatment to an initiate arginase other production Under lungs. fibrosis. the arginine, CF arginine. for agreement a to neutrophil pulmonary file of application and inhibitor of Arginase non-oncology rationale, in turn, to in in collaboration This develop rare the FDA have increased Reduced oxide orally specific the Reduced of proposed in has selected and a and inhibitor cystic retain in oxide is airways pathogens. nitric U.S. new lung we been Based for thought I colonization reduces arginine. directly have XXXX. the of unique, novel a plan of cystic cystic worsened IND, observed disease the infiltrates arginase arginase with airway with the on of Incyte, diseases. secreted exacerbate non-oncology be impairing or disease including Phase

are announce role to immune inhibitor. and on has molecule, an been we're also molecule onco-metabolism inhibitors that the of to is small to enzyme today, can we CDXX candidate, our to CDXX. active orally, drug the building metabolism site form, in CDXX potential CDXX next no a pipeline the tumor cell team small because of there of inhibit are therapeutics. an that inhibitor focused preferable orally excited the an due ATP a to form Our a adenosine tumors. efficiently CB-XXX, a And preclinical both bioavailable thus and directly the clinic, immune knowledge, self-surface plays converting Anti-CDXX some early in in our trials, antibody currently of dose extracellular small that small development. activity surface in CDXX into clinical bound antibodies adenosine. molecule a pathway has a forms extracellular be and are to cell the soluble but enzyme binds in soluble critical may powerful molecule Adenosine and inhibitor is in and believe

inhibitor combination which is a in also of compound solid with a in The cabozantinib types, an everolimus. are XXXX, and combination We XXXX, file lead of Phase two or in status the ongoing executing inhibitor in as plans partner, INCBXXXXXX, placebo-controlled trials we CB-XXX, actively two our with trials serve in development three plan treatment combination initiate arginase, and is II patients of to glutaminase IND studies have as in regimens. combination candidate inhibitor, continuing a a with fully with Calithera; chemotherapy and identified programs, The Incyte. monotherapy, CB-XXX, being cabozantinib carcinoma; an I, tumor and trial. fast-track the broad different our owned have enroll are may in our to XXXX. In range enrolling is the with with with inhibitor, CB-XXX as PD-X developed other for trial is INCBXXXXXX, with our our potential combination and successful, clinical arginase renal for a has by CB-XXX to registration randomized one, in cell clinical we which and two

patients of data, Colorectal the the meeting The CDKX/X quarter inhibitors potential And presentation AACR with mutant investigator-sponsored of and PARP April. an CB-XXX in in the included ASCO in of cancer second at also CB-XXX highlighting of inhibitors at preclinical June. trial PIKXCA presentation successful clinical the

on deprioritize cell the and of we efficacy in development of strategic made plus in we therapies standard-of-care based the includes with of decision CB-XXX carcinoma are date. We solid the and the combination developing In landscape CB-XXX have other activity of triple-negative results This assessed committed the treatment to a tumor are executing that in factors. have paclitaxel the Phase other breast our to recent recently types. CB-XXX strategy. renal cancer parallel, We changes on to II competitive for

enrolling trial TNBC Phase As the additional into a at now we result, II patients be time. will this

support are investigator-sponsored as inhibitor both on trials. a data, in own as inhibitor. and other we antibodies, clinical CB-XXX We PARP and interested our continue to with with CB-XXX, to a well anti-PD-X combination Based enthusiastically preclinical CDKX/X trials remain

with continued keep the also mutations And We X in update pathway. turn developing nerve over the have I including with an the CB-XXX biomarker-defined in on in patient interest for to call to population, will mutations and PIKXCA that, pipeline. those Keith

Susan. you, Thank

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

focused path currently on a carcinoma. CB-XXX renal in cell for are We clinical commercial forging

a of of conducting trial CB-XXX X:X combination at cell presented being efficacy in or and everolimus II The either evaluate is of placebo who randomized including clinical renal the ASCO in with United RCC, in conducted lines plus safety CB-XXX are receptor The a VEGF a basis designed XX ENTRATA trials at have for sites multicenter at Phase kinase we plus of prior patients double-blind tyrosine systemic this as the in XXXX. survival, least year to therapy, CB-XXX States. in is earlier assessed two II clear-cell will two to inhibitor. is treatment Patients data the randomized the everolimus. of carcinoma. August RCC the approximately The progression-free combination late-stage placebo-controlled and GU, survival primary are patients, randomized with be of been The safety treated efficacy targeting study CB-XXX overall was everolimus in trial in with Phase endpoint. secondary everolimus endpoint being initiated On

of trial everolimus the the the analysis primary been Enrollment the U.S. and to slower fourth the XXXX. endpoint use enroll of remain to of in track reach a expect or to due early expected, We by the on XXXX than in quarter reduction bit XXXX has

survival endpoint a secondary will X:X to a and who cabozantinib. have least to are safety plus actively ipilimumab-nivolumab clear-cell being Overall cabozantinib independent II efficacy in one trial by CANTATA combination. placebo survival by review. primary key which with CB-XXX registration received is designed Patients versus CB-XXX the are randomized therapy, lines risk the a in stratified of a line Phase progression-free Phase plus as a RCC for second with Exelixis assessed evaluate or The enrolling supply the two one cabozantinib to potential. category April or us at The randomized of prior global be IMDC cabozantinib CANTATA and patients, prior entered trial, treatment patients, CB-XXX of cabozantinib improvement RCC CANTATA, In with Patients support either will XX% anti-angiogenic prior a placebo-controlled plus approximately anti-PD-X, or combination in material agent trial in combination is third with and placebo endpoint. power We II therapy. show study has progression-free was PD-LX XXXX. in also with cabozantinib. survival. has including into initiated XX% previously of XXX is It in agreement be in

investigator-sponsored an and trial Moving I Comprehensive PIKXCA capecitabine At recommended the presented is Center. tumors, cancer. the of and is portion late-line Eads clinical advanced Phase in Jennifer Colorectal in The treatment Wang, by Phase the of with regimen II mutant and combination safety of Cancer of were cancer. to with the to the trial solid results trial John designed the of evaluate on to the activity determine from Doctors, patients Case of CB-XXX Western Colorectal patients designed ASCO, dose the refractory portion while

tolerated prior full dose PFS for prior twice there of favorably drugs. one X the the toxicities, meter used late-line with milligrams XXX XX the cutoff had the cancer Phase patients capecitabine dose fluoropyrimidine-containing These per at PIKXCA the milligrams cancer is for twice progressed and months. XX dose Colorectal a combination, patients presentation, data to the had well cancer. CB-XXX expansion cancer The patients plus recommended fluoropyrimidine-containing for the were is at was Colorectal day least Colorectal cancer of dose-limiting was ongoing. And Colorectal XXX II at of have the no third-line both must patients on at median of the on with including In cancer a PFS mutated XX colorectal doses weeks. II CB-XXX day. the for As is enrolled, compare PFS with Phase capecitabine escalation study results The with Colorectal historical been where All square portion trial, mutant progressed phase patients, therapy. therapies median Colorectal receiving in standard-of-care and the approximately data with two patients PIKXCA was weeks. wild-type regimen, PIKXCA X XX patients median patients

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

now combination The II combination first the enrolling. the and both has are trial dose with XXXX in expansion cohorts for and as monotherapy for Phase selected recommended pembrolizumab pembrolizumab, evaluating and the monotherapy been is a

daily patients trial regimens, cancer, For squamous the cancer, clinical twice and orally lung FOLFOX, gemcitabine/cisplatin evaluate cohorts non-small administered combination diagnosed endpoints Mesothelioma. designed doublet cancer are to neck and melanoma, enrolling cancer, chemotherapy in each is and head X carcinoma, include response with second pembrolizumab rate. with cell, Gastroesophageal safety or of Colorectal cell combination, paclitaxel. the objective Primary urothelial XXXX A cell

of patient our we pass this We on program. to experience With it and year, financials. this over forward on that, deal XXXX Stephanie for are an future accumulating update with a look I'll great updates to

were quarter. the the Cash results ended period that, $X.X And I XXXX, million the year. operations ended will capitalized, XXXX, back technology call was over everyone. compared with quarter quarter our ended or XXXX. for were $XX.X to afternoon, XXXX, loss June the We $X.X prior for were Incyte investment quarter million same in same for and the increases a primarily results The review programs revenue services was clinical compared were $XXX.X expenses XXXX, ended compared XX, under today's the share. programs, million our investments this development and for will million press CANTATA $X.X personnel-related June $X.X year. remaining at meaningful the with Collaboration same increase value under Thank for for the XX, which XXX well programs. result, million quarter in you, enables per ended obligation million completed CD-XXX points. with return early-stage which call. The XX, Calithera million current to manufacturing expenses ASC was and clinical due on satisfied including Net the for as XXXX, prior performance period our to and increase for briefly June us in deferred Detailed good XXXX June the release. now year. included second with to the XX, and in which Keith, Research June quarter was quarter $XX.X and CB-XXX, administrative trial, a Phase from costs. revenue our inflection X II research in as prior to recognized agreement, was development and our transfer General as XX, the due our $XX.X financial well for the opened drive Susan. I period $X.XX million XXXX

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

question Thank you. comes with Jonathan Our first [Operator Instructions] Leerink Partners. Chang from

line open. Your is now

Barrett for data the you Thank actually results on of of upcoming discontinuation still call. that present you related is in John the any of any you to discuss the do allowed Jonathan plan the to year? - rest everyone. Can taking Chang. Hello, And elaborate to you're this for This TNBC? our on of for

on priority later this further lower remain but to do we and year, at for this yes, the track So is present data - development, a us. time,

and further current patients develop follow approach no is time, the in to to will at we this be year. continue of updated the We But data as there plan TNBC. end

more. one And Great.

the to drugs rationalization little bit out the a for now developing for going cystic more these idea are going be fibrosis, can new about You just talk in you that? and

Yes.

the neutrophils quantities So infiltrating inflamed being also is sputum, by and leads lungs, lungs, greatly of infiltrating cystic levels very the their it synthase patients sputum. greatly granulocytic talk cystic these high key fibrosis out patient nitric in as reduced turns have cannot arginine, where produce about patients reduced cells patients nitric NOS, nitric of trials levels And demonstrated is in cancer arginine releasing well And infiltration in in same oxide, then the it in substrate the arginase you arginase. and - the sufficiently as exhaled fibrosis is to previously, so for at which enzymes. tumors in is for this large has patients' arginine critical oxide highly production lungs. includes are been we can find that these MDSC, patient The clinical oxide And NO therefore, patients.

in produce the bacterial can we or arginine component program nitric allowing So an it for to to fight lung, oxide immune iNOS has X the also is effects, the bronchodilates the important the it in lung, the of and function is infections. off levels idea replenish replete which

useful of functions basic we the NO other So we the a as is this recently, ability replete has lungs' note, be think the see of as I that's - NO rationale. as well will been produce in what should to another there the validated to lung. other, arginine approach as therapy and use

R&D to forward thanks. Great, I the look day.

Thank you.

from Citi. Our next Robyn question with comes Karnauskas

Your now open. line is

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

and the seen these the I have better cytotoxic they for you. arginase. pathways in these efficacy? either to any you of master in in data how these effects, have one think about learned better in metabolic have you it talked you terms but lower TNBC there Thank oncology least of Or are that think pathways TNBC exists? actually have that a such particular, to how the following glutaminase, do that target know the at inhibitors if target So be metabolic drugs you've in in use combination you've lessons CB-XXX might regulator

This Susan. is

to be inhibitor to will taxane - our contamination thinking frontline before plan combination not they preclinical and recent several be with has the testing combined we We with showing since end large, the a that We in development data It cancer the data. with we thesis. clinical has clinic and in therapies become basic become different that may a PD-X crowded CB-XXX, poised in more match, has of standard data with we care. effects changed planning and changed breast by in the and field, believe our addition TNBC present the year. were of have Triple-negative presented our taxane

So that for the the data and that it's designing concluded that our making this randomized at going a time no us there is forward easy change thesis are it's forward biology, have TNBC. not trial about way we in

chosen carcinoma, cell have other renal in to we So put our colorectal efforts and indications.

And you. Thank the question a further see combo any we nivo-XXX on great. from Okay, updates trial? will quick

developed a in Squibb. combination that's that's so Yes, being with Bristol-Myers study

the from where And so that agents what we to we've working we And is data combination. continue for XXX together. are path best forward with BMS the those ongoing to evaluate study, combined the determine

we'll guidance being we that an data actively specific ongoing strategy discussed. but on present is provided effort. So time haven't And that that's a

you much. Thank great. Okay, so

Thank you.

comes Our next Phipps William from question Matt with Blair.

open. now is line Your

my taking question. for Thanks

target. a AXa target Just so a been intriguing, complicated, this There thoughts adenosine multiple to the are receptor. on your bit couple of kind the the CDXX, pathway pathway, little CB-XXX, just ways have definitely but on

or mix underwhelming? guess, So small Some AXa the rationale have a thoughts versus guess, is, I at any the guess, of CDXX? initial you So ongoing molecule seen we've receptors after date, little just CDXX? the wondering for been just I I

Yes.

and we've we believe date. challenges used I to is - to been we pathway, So a with likely very target approaches a know unique that it. got - are you we are this think And there mean, way important as will that absolutely. have the

jury inhibit CDXX, that enzyme we have still potently activity inhibit generally that the antibodies, is the molecule about out which CDXX fully with very within think I to will the are confident questions the and - there developed enzyme. But for small on approach the are that has the those. been antibody, we ability very

adenosine. receptor I concentrations are has approach. given obviously, XXX with challenges think a inhibiting fully of those the There AXa receptors, different local also,

challenges so And of are think number I there as there well.

So important being bear administered again, - an orally we targeting that this And approach an gives more agent we think this a to the approach pathway. will for fruit. think to is us ability convenient

Thanks. from I of regimen in new follow cystic kind up could fibrosis in treatment into the CBXXX. landscape And of another alter of, some The leaders here likely couple next the advance is if with on going the of really triplet to a kind the space, years.

something do you of potentiators the I on to of for plan you how that some into So is molecules? assume small development look that incorporate this do top CBXXX? of

Yes.

independent So we see this as mutation of status. absolutely

we activity whatever of that across patients. of And be range be have So that they will we top on corrector may the believe, therapy will think applicable mechanism this on.

on aspects other the So key the that activity this gives clearly this opportunity discussions approaches us of do are within space. think with and be opinion developed a broad disease. ceiling need is we to our for leaders, target you of other other But there's - that mechanisms being this corrector or therapies, from likely - agents the There is there in a other a way.

patients. for in we fully of important that room corrector recognize these new of moving while the therapy therapies there's plenty will these So that - improvement further forward, components

you. Thank

Thank Yeah. you.

you. Thank

question next comes JMP Konstantinos with Our Securities. Aprilakis from

open. now is line Your

question. Thanks for taking my

approach, are you molecule a was So, companies against potential of if by antibodies against a challenges And those a molecule perhaps discuss Susan, developing hurdles? how of approach and I wondering exemplified you the and that of as other the small could CB-XXX, CDXX overcame platform mentioned advantages your pursuing developing CDXX? review number small

orally a to for to us we've to that with the a have to arginase a bioavailable been a has into do. make been go to molecule concerted very to CDXX. goal And allowed can first extremely is an And that's and inhibitor is glutaminase able potent have we had molecule. was We It happy team been that is very and it fortunate first inhibitor of twice clinic. making the it effort small safe. develop be sure orally we've what difficult a been molecule bioavailable day the dosed quite chemistry same But and the develop certainly and

and So developing we really got. we where the our very with we are to this I'm pleased pleased progress had have we've we made, that certainly got molecule. particular challenges

Thanks.

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

today. and New research CB-XXX, Thank and any with Day you, that have October in we you. today's on additional planned for and Joel, particular, we meeting, programs, to you, this I there. on call, an remind questions We company's CB-XXX We, us on able thanks we joining address be all York thank development hope to calls will R&D follow-up and you X City. focused weren't want the your have and at that again, welcome see you to in may

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