Calithera Biosciences (CALA)

Jennifer McNealey VP, Investor Relations
Susan Molineaux Founder, President and CEO
Keith Orford Chief Medical Officer
Stephanie Wong Chief Financial Officer
James Shin Citi
Matt Phipps William Blair
Jonathan Chang SVB Leerink
Arthur He H.C. Wainwright
Nick Abbott Wells Fargo
Call transcript
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Ladies and gentlemen, thank you for standing by, and welcome to the Calithera Biosciences Fourth Quarter 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation there will be a question and answer session. [Operator Instructions] I would now like to hand the conference to your speaker today, Jennifer McNealey, VP, Investor Relations. Please go ahead, ma'am.

Jennifer McNealey

Joelle. you, Thank everyone. Good afternoon, our year-end to conference XXXX Welcome call.

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

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

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

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

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

Susan Molineaux

And towards both in while proud our novel we the of of novel challenging a for entire in say for year biotechnology all and a our particularly goal challenges public nearly dedication a and global everyone, patients and being of inhibition to line friends afternoon, of of of CANTATA We're in clinical in want professionalism, team you, we healthy. the Jennifer. to pathways for successfully our year-end drugs, your and we and today positively was that of goals. the and job immune an potential to done January. tumor cancer. metabolism therapeutics. level us enthusiastic the integrated we results reporting in cell for joining extraordinary pipeline us mission an are be you thank high company onco-metabolism our and of commercialization. we of that at a glutaminase drive programs cell as of other to for disappointed remain faced, number randomized hope work, the results maintaining our for reported develops novel thank By of approach Thank Good new novel fourth we future. CANTATA results early conference candidates, appreciative cancer was year towards opportunities families who drugs trial treatment of execution. the everybody product development committed Despite diseases. for health. the a outcomes On employees are we challenges our the pipeline challenging remain therapeutic face small of XXXX and team, of that have helping the remain We behalf like We molecule entire achieve I'd multiple advancing impact treatment our you building And to creating of call. on accomplishing productivity hopeful top to are we completed while a XXXX and carcinoma trial, quite and trial quarter of renal of XXXX, At Calithera, are targeting the XXXX

or NRFX. randomized telaglenastat, cell enrolling we and trial continuing non-small the harboring genetic first mutations KEAPSAKE in are are to line KEAP cancer develop patients We lung in

evaluate telaglenastat indications, continue including also investigator-sponsored to in multiple trials. We

evaluating treatment partnered of inhibitor have of CB-XXXX the Our ongoing number program with cancer. trials arginase is a where we Incyte clinical for

permitted under time, internal programs. resources the to our this co-development in effective to decided XXXX, on of have own terms our Incyte out opt committed remain While we obligations development the confident as development our the we focus at XXXX in order of and September agreement program, to XX,

of our decision Incyte the And be a all them. we the awarded also fibrosis. for result out, unique of accordingly, grateful of we November that a we Foundation oral XXXX, Fibrosis patient In cystic Foundation the pleased support announced to $X.X treatment from As clinical are their Fibrosis inhibitor, inhibitors selected and to were potential will to develop opt we're the of for have to pay working we million up in with Cystic population. Cystic XXXX. costs to Arginase And CB-XXX, development this to support, arginase treatment CB-XXX.

a and novel broad remain needs. on highly for to we on unmet pipeline in of differentiated And areas the with be clinical to focused programs. and will with I We therapies the have over productive Keith call potential R&D producing pass that, team, our details additional a candidates drug new

Keith Orford

Susan. you, Thank

lung for that of KEAPX/NRFX Numerous demonstrated of including our pathway Let's XX% telaglenastat, or inhibitor therapies, treatment in with makes in the on begin chemotherapy, Preclinical with chemoimmunotherapy. a either KEAPX plus by telaglenastat receiving first this telaglenastat enroll trial through pathway, update more Stage loss IV the will the activation the double-blind activity occur disease. sensitive NRFX interim known the of of enrolled non-small dependent September of glutaminase mutations. activation will will newly are are trial, immunotherapy clinical recent of with care lung and or of standard and cell with diagnosed evaluate frontline survival, with tumors in and Patients data of of investigator-assessed among that NRFX, The regimen. KEAPX/NRFX placebo, which to shown from second the pathway, pemetrexed. standard with have the non-small cancer randomized in plan with non-small for KEAPSAKE, an be associated cancer of as data in in reports function patients Eligible XXXX of carboplatin and this half receive that mutation. combination patients safety outcomes making cancer lung activity patients. cancer share clinical XXX Mutations tumors XXXX. and associated The glutaminase detailed pembrolizumab, patient poor care these models KEAPX/NRFX exquisitely patients chemoimmunotherapy cell are cell KEAPX to activation in approximately or PFS tumors first-line study telaglenastat have on lung the estimated non-squamous with aggressive growth We of development the to patients, inhibition telaglenastat. have glutaminase

the and Fibrosis fibrosis. potential the the cystic models. by of North XXXX, Ib/II evaluate of cystic We may a the study cells, several improved lung collaboration American are trial produce preclinical an the hydrogen an CFTR-expressing telaglenastat half improved cystic in our fibrosis, inhibition phenylalanine, treatment owned cystic the Phase CB-XXX to Pfizer We delta inhibitor of and cell nitric T Cystic with initiation knockout IL-XIX poor Therefore, to we central in conducting mice airway pseudomonas exploratory In tryptophan CFTR in depletion arginase solely fibrosis tyrosine outcomes share resistance describing inhibitor, trial Calithera, aeruginosa. of oxide, an plan with and infected resulted administered with IL-XIX production therapy tumors. and included types, we The CB-XXX results, an with preclinical in also of peroxide, October ovarian reduced B-cell decreased has colony-forming infection in wild-type to by with cells tumor have the inhibitor first-in-class, in announced high significantly mice checkpoint in this tumor expression presented CB-XXX, Arginase potential the role expression identified elevated and in suggest at expression CB-XXX of second pleased are IBRANCE. metabolizes have fibrosis, The selected IL-XIX enrollment treatment first with antitumor presentation IL-XIX, inhibitor is by to immunization antigen also enzyme that and clinical from in date. the in particularly cancer. trial of in been correlated trial and with multiple to poster FXXX arginase key ability combining immune reduced data units lung function. the antimicrobial a novel inhibitors has we tumor arginase approach orally we presenting enzyme types which response. inhibitor and and enzyme in the investigational for a XXXX. results patients of conference. pseudomonas and to in in arginine is as an design decrease potent, of aeruginosa an function arginase stimulate trial novel XXXX, a immuno-oncology CB-XXX, oral in In We've unique a bronchodilator. progress expressed is

financials. New for CB-XXX meeting. over update preclinical on for it Society XXXX Immunotherapy that, of pass at the in I'll to an our presented Virtual was Cancer Stephanie for With November data

Stephanie Wong

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

million and year. Net other will quarter increase of XXXX increase net million fourth due XXXX million $X.X through for in I $X.X period return for ended R&D program in primarily XXXX. for back the by million December to million $XXX.X the XXXX. a of facility $X.X quarter a in were $XX.X increase million an to $X.X Our quarter increase personnel-related million the $X.X for in $XX.X was at $X.X operating million in investments which and XX, million and $X G&A million. offset decrease year. million were the the meet quarter cash, expenses partially were net in was The and million in program. the in with $X.X plan Interest quarter fourth $XX.X increase and equivalents with December services. related R&D call a sufficient believe expenses and $X.X $X.X to million that, early fourth $XX XX, same the compared for same for and an to G&A telaglenastat loss fourth be income professional to compared $XX.X in current expenses to the research, of now costs last XXXX, XXXX, XXXX And for XXXX were to million period we income over last in decrease will expenses of XXXX. program a stage CB-XXX other our to XXXX was million Susan. in million The million cash $X.X was XXXX, XXXX. XXXX. the of decrease $XX.X million were in XXXX $X.X the the Interest compared $XX.X of compared million was compared to compared million

Susan Molineaux

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


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

Your open. is line now

James Shin

on James Mohit. This is for

this related showing higher know was to KEAPSAKE but patients. a still point? Or you had that KEAPSAKE, the later give data for progress there a color KRAS track on year, in response little some of trial on First I And at that question, us And the a that any bit STKXX work proportion inhibitor. some this of to progress? a from a enrollment you we're that know then data KEAPSAKE? of is the for number good have sort have I KRAS mentioned previously STKXX will guys patients recently mutation can

was Calithera So combining inhibitors? KRAS wondering looked if any I at XX with stat

Keith Orford

this Keith. James, Yes. is

In as terms this data said, enroll SEM we and enrollment, initial make planning interim we're the analysis from so to later public of year.

would say, impacted has by enrollment think been, I COVID. I

our asked interim you in we're time this analysis anyone, working data able been COVID, to impact something that to think to later -- if through, be some has -- from that all probably year. it's line and remain on to we but I confident get there

impact, that definitely we working through. something So but some are

impact out. guess, work in. a of a would actually that's be definitely remains couple of interested the think quite the of two looking I an we're STKXX of But that that interesting a there's interest. between definitely to KRAS the different, into that story, how in inhibitors our terms a on of so that that I clinical been sort a, different lot I side. interest, KRAS were And and progress, plays will But area combination somewhat we're see of reports something say, of In it's one on


Matt comes William with question from Phipps next Our Blair.

now Your is line open.

Matt Phipps

to I see, PFS thinking guess response around interim. the that assumption? there kind any just data this a are maybe as of there will of I just X I you mean, opposed And has be of to Keith, an been that for rates. PFS, control in Or on right, still arm months? follow-up lately interim change

Keith Orford

different have of -- places, in a X-month that put -- population, been So population, terms the in actually range. been, in median few for reported so the X- data the assumptions, that Matt, terms in yes, the somewhere for we've that KEAPX of immune so to the this probably

in So this is and -- frontline.

of and yes, be be as poorly, PFS that analysis going very combination will and in a do data what kind be to And -- be we as it's the we're talking assuming. of maturing. data rates. patients terms would interim probably of so that's about, these So data well The response will still it's the an

So able not PFS -- talking be there. to the the between right to expect but see the for would median mature given control the we're going in we PFS, fully a trend curves X expected do see about some arm, some -- see data, and be daylight short to hopefully we direction

Matt Phipps

that in see update And IBRANCE year? an we from any this chance combo pancreatic

Keith Orford

that. haven't We on guided

next. enrolling. say But hard a study it's little will year just think to really be exactly likely started it that or when I this

say to certainty. early too with it's think I So


Leerink. comes question Jonathan next SVB with Our Chang from

line open. now Your is

Jonathan Chang

can mature the and how half data provide could question, for thoughts First latest interim KEAPSAKE how your much second set you on be?

Keith Orford

terms out an in of analysis. It's statistically of before, year. not as an ballpark. futility XX It's XX in starting and the about is range not mean could patients' regulators, at I analysis. explicitly reaching sort subsequent interim defined -- analysis in -- of think react for of the endpoint things, -- look with to kind not And the us which expecting having an early early the end we're yes, that's talked any by and the of somewhere number a data that the a to to It's to analysis. the of specific allows appropriate, have Jonathan, the protocol study. data or prepare driven as of efficacy It's administrative we've worth a

who So the closer interim guess, hope censored have that's that get feel I for spirit a for I is patients interim. later as mature of scans hopefully -- less will median were we and couple The say, the data. of to patients have we obviously, that would enrolled be more of And the terms of get so patients analysis, maturity, to likely those a as be kind the the to those PFS. in can

the range is the of about, talked X arm, control would median we expect. As we to the in for X months

So time to if separation early that see at encouraging. we can start point, that be would

Jonathan Chang

for your thinking you potential business And last question, about development how are opportunities pipeline?

Susan Molineaux

several opportunities continue we Susan, to pipeline. partnering In to is develop remain Jonathan. to this Well, general, our open as of one ways

data we out read earlier in the ready. line. stage will data fibrosis patients. might have if this you we cystic and assets be And somewhere know, a there an We where fibrosis cystic might year development go do IND we the first encouraging pipeline a And that opportunity along that clear picture of look time as are next, partnering have

we're develops. right oral open as always And see inhibitor, have wait have We time those molecule small the for CDXX and IL-XIX. for a reasons. inhibitor at the But and for for possibility what right also we'll partnering telaglenastat, is well. we an a And partnering to


comes question Wainwright. next Arthur with He from Our H.C.

open. now is line Your

Arthur He

So I two. have

regarding missed. Phase regarding us the some So I color Could expect data could I/II with IBRANCE, this KEAPSAKE of And -- on telaglenastat study, regarding maybe you give we second, study enrollment? any the update year? the

Keith Orford

-- is Yes. that I numbers terms in while give enrolled, sort some impact did mention we don't been patients there there enrollment KEAPSAKE, specific COVID. Arthur, of from for of usually of has

study patients multifactorial, frontline sites a level patients getting to of and is necessary in the ways staff diagnosed is as study. -- well there's in probably since the through the it's this as setting I for enrolled various be patients, the think have both impacted who the at front-line

from real -- ways and track, clinical The year. terms think in enrolling, we're then have are the still mentioned, study, studies, there think, the I study I data But we're, impacting of experiencing update of everyone So end that is on like no COVID is which the by else, as there. -- for we there I the that. perspective. and and and we remain in enrollment monitoring an data IBRANCE

that I hard or be than data the but this either that point. think at probably more with we to talked next study, year this about specific


with question Our William Matt Phipps next from Blair. comes

now line open. Your is

Matt Phipps

could walk I steps -- Coming this Keith, back just after guess, we through was talk hypothetical some, on. next interim. wondering I if

depending run of the maybe looking the out? to curious present to are continue what interim you'll some the the this okay, next -- it, steps obviously, it of is things does let having So okay, expand if kind going enrollment we built-in but trial the take on level just data we're kind maybe adaptation Just trial after it are look to Or the it of -- is to make in good? activity, there to Or go pivotal potential KEAPSAKE. FDA? is

Keith Orford

So the a things we're that's kinds about. thinking of are those question, great and

out data And talk we about planning study the amending to compelling. example, can or subsequent For III. Phase current FDA breakthrough always a for about pivotal the with starting the reach if they're designation, for either talk example,

of of kinds the FDA interaction an things what an way. forward the of is. be are kind think again, sort of to a accelerated options. if those path we looking in some that best we move with those that, would And to all we probably of on by can So were with looking are early, And really part path start get approval

Matt Phipps

Do you the before occur the present time reach -- imagine submission even the abstract given to out you trying data would with FDA lines?

Keith Orford

FDA any a the interacting kind of -- FDA meeting. with So of presentation independent would at say is I

presentation. may may an conference be this presentation, each conference So about we've necessarily -- frankly, we're is the to or prelude may be I or a about other. that a what so think wouldn't isn't even I what actual talked -- a talking And link to not past those in

year a in of that context necessarily wouldn't discussion the conference. this So be the


you. not our Thank further Wells questions. with any question next Nick comes I'm showing from And Fargo. Abbott

now is line open. Your

Nick Abbott

the And I I prepared of all apologize missed remarks. nearly

ask the not January, June. study on insight of you they're have NCI into that about question know want end the data telaglenastat I to trial, updated So still a of but was at may having a in lot and I of talking

So have into KEAPSAKE mutation? some a any you that trial? these may way to is have who of help And also do KEAPX derisk also insight a this patients in

Keith Orford


any -- the talk So don't have actually, share hi, insight real on point study. by can this way, the of we as -- at we that we about we Nick,

whether it's the this about looking TKIs mutant about point, KEAP with just think that study an question, mutations, patients something it. it's not at look But interesting driver to. I an it's we think speak or targeting learning interesting So and able more forward to at combination we're it's I to

Nick Abbott

the I by just know there questions you a beginning open cohorts And lung Okay. you're for that Can mutations? or been the the cell remind referring is to few And being next? were then IBRANCE of the year when this and combination. KRAS of us -- end non-small possibly data the is colorectal on had available

Keith Orford

that's a So question. good

when be to sure not my able to I'm it I'm memory going testing up. accurately You're the and looking study opened, of answer without that

So I say cohort pancreatic the -- pancreatic apologize. the I more recently. can opened

added study that to one that was amendment. by So we the

timing back on data could colorectal be -- we'll of that, I of I'm the But sure we any was, answer or data get pancreatic, the I last that know those somewhere. the for and the all those think, have present, that say, And I from head of if sit the that I in so possible. should you here. But ingrained think, opening, can that start year. the as don't will lung we could I late is cohorts data that data you the of colorectal and though, study. timing to I opened cohorts my the or


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

Jennifer McNealey

evening. joining Thank Have us a today. great thanks for you, Joelle, and all


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

You may now disconnect.