Calithera Biosciences (CALA) 9 May 212021 Q1 Earnings call transcript

Good day and thank you for standing by. Welcome to the Calithera Biosciences First Quarter 2021 Earnings 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 over to your first speaker today, Stephanie Wong. ahead. go Please

afternoon, Conference Good to first our Thanks, everyone. XXXX Call. quarter Jeff. Welcome

today Founder, results, calithera.com. afternoon, Joining and Susan XXXX website an are me Molineaux, at first our be Chief, press which quarter Officer. accessed overview a our of Keith and President Medical Earlier can issued this operational we financial release, included which Orford CEO; and through

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

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

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

the and today Thanks, everyone. families of you I'd first team, our on us and XXXX to Stephanie, your quarter that afternoon, call. say, joining remain you friends good behalf entire and for we like conference On Thank healthy. hope

and to patients. worked illnesses many to and will Their people later their and grateful both programs, to develop In to continues frontline to busy dedication which milestones in to our vaccine. readouts normalcy to companies, developing been allowed clinical return scientists, fibrosis sense difference return and we we have quarter, to has therapies world make COVID-XX, novel Calithera that drug monumental this medical forward are first push to of allowed of for cystic data some us cancer have treatment the is achieve As a workers to of that centers advancing like have deploying key year. the serious where contain working two the expected

First, releasing has non-small is cell fourth non-small cancer patients. with in the evaluating continued the with trial genetic first-line randomized lung for interim standard patients KEAPSAKE this for cancer enroll in care XXXX. cell NRFX trial data to We KEAPX telaglenastat anticipate chemoimmunotherapy of KEAPSAKE mutation. or of combination quarter lung

and sponsored to and telaglenastat continue combinations investigator also in trial. evaluate in indications additional We

CB-XXX, Secondly, escalation cystic a enroll Ib our for in dose fibrosis to trial. is oral arginase inhibitor, Phase of the patients treatment continuing

arginase this XX,XXX a inhibition CB-XXX, third-party over by with there a CF. first-in-class cancer. that know, you Calithera developed population. stems potential As evaluation patient in also research, We market owned treatment. critical of partnered are living According to inhibitor arginase interest with, in people role XXXX for being Arginase Incyte the is Incyte treatment arginase from disease a the plays fibrosis cystic our airway for in molecule by could wholly identified be and and oral

advances CB-XXX of area CF Our modulators, unmet with have potentially CFTR need This people in model has recent impaired is poised lung seen patients treatment that function. an many fulfill. to for still with is

ongoing our We second in from announce trial XXXX. data expect to the half of

forge and XXXX. including them. the an work in program. their looking will that, CF unmet are our over ahead and need. have $X.X our CB-XXX in pass therapeutics experienced eager has to vision Cystic with to with provide and high details we to of the management our research paired and we Fibrosis team our I the always Foundation, Calithera discovery, award pipeline year diverse and million to development And call to program, of development of had to pleased clinical an an also Keith support team, continuing look milestones in With for to with exciting of are novel at exceptional clinical on the up additional are areas in capability, broad forward expected for We the this KEAPX/NRFX

And an you, start Susan. Thank I'll around telaglenastat, glutaminase providing inhibitor. by our update

We population KEAPSAKE are targeted cancer non-small in cell patient a approach the evaluating telaglenastat lung in a trial. with biomarker-driven

assessed or to non-small enrolling this year. need patients preclinical provide in XXX regimen. Based look KEAPSAKE fourth central we studies lung in quarter XX% harboring pemetrexed. models have Over NRFX have tumor to randomized safety analysis to non-small outcomes standard plus cell to and a of receive evaluate wild-type protect that glutaminase of plan interim driver The activity telaglenastat unmet of mutation, growth KEAPX/NRFX and September improve investigator enrolling tumors cancer tumors patients making oxidative and outcomes for KEAPX/NRFX being strong survival. KEAPX/NRFX of dependent retrospective and proliferation We has these data patients inhibition poor the tumors have cancer prognostic care pathway that a cell of shown activity an couple shown or patients with NRFX In of in on stress PFS the of patients these patients area trial, mutations non-squamous, by This well KEAPX non-small not on cell able on begin that exquisitely the the survival, harboring the chemoimmunotherapy. years, of role that cancer an and as and that and mutations. sensitive carboplatin, in will lung lung the last mutations the placebo telaglenastat. mechanistic potential for believe are pembrolizumab, and Preclinical telaglenastat trial makes from rationale to share have clinical tumors this chemoimmunotherapy we glutaminase may combination promote is growth study XXXX. this driving tumors to respond forward standard-of-care KEAPSAKE study glutaminase KEAPX with patients activation in estimated these of or and

are cancer exploratory an also presented of endpoint in analysis carcinoma in Annual of Earlier from continuing colorectal therapies. Phase assess that all-comer with the cabozantinib to announced telaglenastat Ib/X cell have year, checkpoint did patients the an combination trial with the Meeting in study progression-free not antiangiogenic conducting improving renal progressed non-small and from cancer, CDKX/X trial in that evaluated will population or results CANTATA primary June. This patients the collaboration telaglenastat lung we cell inhibitor this trial Pfizer. in The ASCO on survival. meet are with We which immune its palbociclib inhibitors this be at final we of pancreatic

CANTATA setting this patients adds contemporary these study field treated presenting the believe we by forward to with second disappointed ASCO. in presenting outcomes the results, cabozantinib to or we're data of at look line and with we the third While population of

We have no plans at carcinoma. this in cell continue developing time renal telaglenastat to

patients should of in and reduced as Phase increase reduced chronic to a CF arginase approximately significantly has CB-XXX function by XXXX, in and production and dysfunction of our to nitric study dose-escalating the that Inhibition initiation the lung Preclinical planned. The of arginase proline. arginine in announced studies increased placebo XX oral polyamines CF cohorts. are increase novel treatment, of and stable CB-XXX improved we airway first of Xb will oxide mice. demonstrated or on and is infection production airway in be either CFTR to oxide, regimen improve enrolling and therapies been patients antimicrobial The cystic trial Moving arginase of enzyme results on in the fibrosis, cystic evaluate patients proceeding lung depletion function. effects and deficient enrollment randomized nitric in clinical inhibitor, CB-XXX have fibrosis receive

is modulators. care for from We trial to to this plan designed including CFTR in second that of the safely this added drug XXXX. to Importantly, share be standard existing trial CF the demonstrate of half therapies can data

both financials. In clinical are on programs, addition in these oral inhibitor, I'll inhibitor, ongoing have acid, we studies. the peroxide, and and in targets pass CB-XXX to for for tumor our which preclinical kynurenic With over clinical Stephanie microenvironment IL-XIX we update continuing an CB-XXX that, CDXX in to it these immunosuppression candidates

XXXX. Susan. Detailed Calithera cash and Thank well-capitalized $XXX.X you, press included financial will today's our driven I by the primarily briefly R&D $X.X the quarter quarter million XXXX were for to the million review in costs, were the primarily the will quarter loss of related remains first by increases release. I the telaglenastat first expenses The partially compared return Net million investments increase G&A in totaling services. of decreases and $XX.X now to compared decrease the results expenses in with was million. over $XX.X quarter The XX, first in to in March with were XXXX call. was million this results professional the XXXX. back to quarter call Keith. program. And personnel that, first decreases $X.X XXXX current at in for XXXX first was million in $XX.X quarter offset related XXXX. on in of of

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

line your first Citi. first I Sir, Bansal you. will Mohit [Operator speaker Instructions] our from comes thank - of Okay, question the open. line of is

question. is Mohit. This for James taking my guys. Thanks on Hey, for

to given would KEAPSAKE, to Just release sort data good can in XQ sort you for you conference? readout, in PFS telaglenastat? you a a consider or on that KEAPSAKE, medical press larger you can the like be what expectations And patients consider two for like to of arm, is for data you the something of are planning you us but related ones, share release the for could reserve - that quick then Thanks. ORR control for

Hi, James.

substantial to in data, about range, median to of the the patients ballpark would point arm what how like, over talked good the think this the as to terms three we're over today. PFS terms what the and kind key I arm, data looking be in we do poorly months a for the control maybe that So these expect looks improvement of is I a yeah, in mean, we've for be five of before control

incremental for looking improvements. not small really we're So really

We'll see And how will it to number But improvement something a provide not we're that's medical out. be and looking statistician it for and terms So a done, what works or you on for - way. for I put goal we're that hesitate a specific of PFS. the is Presumably, clear a wait conference. in to said the is when I done, timing, that subtle. going here not a based to specific necessarily all to how it then determine, need be think to something

Got it. Appreciate it, Thank guys. you.

Yeah.

you. Thank

the of question Next Blair. line of from William Matt Phipps

line open. Your is

Hi, for here Matt is Andrew on Phipps. guys, Rob this

couple if I a Just may.

at was NRFX through pathway key occurs kind tumor which So interesting T-cell couple here an could AACR. first glutathione. of pathway killing since pathway one, that evidence of as cancer cells well. And has similarly of of some then presentation a kind be involved regulated a that by of it to weeks mediated the glutamate ferroptosis was of it That in been literature seems linked the ago this and it's exports highlighting as in suppression intercellular

that just is just whether and were be pathway ferroptosis mechanism of kind any kind similar And to but seen there's we additional that on a here potential So wondering evidence for telaglenastat question previous then an CB-XXX. that on the can could influence whether telaglenastat? of think of question you've action KEAPSAKE preclinically to second

expectations line with released? the meeting is expecting Thanks. are the conjunction of what on there terms top or in Just in press data results medical

one. an the developing Rob. Hi, certainly so Yeah, is and around story ferroptosis I interesting Yeah. a think one

on an in the were not earlier development area generated. particularly when think program these of I data the of focus, much of

something mean, our I of terms of might good at Research, our clinical discuss studies, Parlati, looked conversation for there be not in But we've further. Head again, a think, that to context. that it's in I Frank

not central or emerged at year guess to two. and together is - So data this we're and interested - given between potentially very ferroptosis and we put very that. but really last relationship we both mechanism, it's over the glutamate you pathway the as did NRFX that interesting a wasn't the preclinically It's say, think the I something time had with early in we both certainly that that

would in of again, terms to interesting. but say let then we'll So very And I be guess I certainly determined, you CB-XXX, know.

a our I do if conference. inform to accepted generally is we once going approach think at we to on to reporting that have be are that conference to been

that I let guess, will approaches. we So know, as you

taking Great. questions. the Thanks for

Yeah.

Nick Thank Fargo you. of Securities. the Abbott line Instructions] from of [Operator question Wells Next

is line open. Your

you appreciate Hi for on Congrats guys, taking and on it's Joe progress Nick. question. the the

date quick I one is us, NCI quarter on XXXX. second it, a missed completion from sponsored combo on-perm [ph] trials; of you but study, have Just an apologies the primary Tagrisso provided the if the update

read-out KEAPSAKE the to prior data think about maybe expecting or be how we should So we that? should

Joe. Thanks Yeah.

don't hard of For timing. all including studies us on our, external studies, comment we CPAP much of to for it's sponsor that sort

haven't and data data don't we and and honest, So - have been those really it not to release, visibility communication no, data our total have we're released we be like it's but not wouldn't be to any have in discussed publicly of that. constant

will know, well are on But NCI's along we these can't and that to speak data specific about we right So be have that but to there today. I now. don't as and just as no far moving really issues, are timeline talk

there. Yeah. Thank it. No, for understood, Appreciate Keith. the comment you

Yeah.

[Operator no questions further time. at Okay, There Please are you. continue. thank Instructions] this

evening. joining have a Okay, thank and for you. good Thanks today all

participating. thank concludes Great, you. that you for And conference call. Thank today's

all You disconnect. may now