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CALA Calithera Biosciences

Participants
Jennifer McNealey Investor Relations
Susan Molineaux Founder, President and Chief Executive Officer
Keith Orford Chief Medical Officer
Stephanie Wong Senior Vice President-Finance
David Ruch SVB Leerink
Yu He H.C. Wainwright
Matt Phipps William Blair
James Shin Citi
Call transcript
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Operator

Thank you for standing by. And welcome to the Calithera Biosciences Q3 2020 Earnings Call. At this time, all participants are in a listen-only mode. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] I will now turn the call over to your speaker for today, Ms. McNealey. Jennifer begin. Please

Jennifer McNealey

Good XXXX Jenny. Welcome our to Thank call. afternoon, quarter conference third 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

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

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

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

Susan Molineaux

that And Thanks, team, your entire and the us today say Jennifer. I'd XXXX remain for you you On family like everyone. Good of hope behalf on we conference afternoon, joining thank friends our call. healthy. third to and quarter

high and of and prepared maintain to for personal our job month. to want who able level pandemic. same the adapted office. addresses safe employees the a At of home have an as COVID-XX of and been productive new have COVID-XX done extraordinary to challenges are thank while most we've workers a the who reopened company to at balancing to environment, and productivity those new the work into employees have world successfully the environment dedication that our We've We with from returned maintaining time, of coming a work for challenges all of all labs professionalism, maintain the our the including the it working normal brings. While we

of been appreciative significant proud year team. Today XXXX are We our Calithera. both entire and a has for

remarkable tumor efforts biotechnology As our novel we advance reporting and position. small our are first toward with building develops towards to drug, onco make cash drugs metabolism pipeline our clinical we impact are outcomes pivotal our and continuing are results molecule creating other cancer for that company treatment trial a to glutaminase diseases. that progress targeting programs candidate our drive development At and work lead commercialization. patients telaglenastat, Calithera, integrated for metabolism pathways development to product therapeutic By candidates, an clinical across we novel and while the multiple opportunities strengthen building of immune inhibitor, pipeline, positively cell of

telaglenastat out becoming of trial. first we We line cell in or activity fourth first are selective renal with laying are This trial plans XXXX the patients, including biotechnology clinical take top step and carcinoma quarter a commercial quarter and our data successful glutaminase activity a the a closer to focused the with enrolled into carcinoma CANTATA, in needed us to fully randomized clinic renal for infrastructure on and cell expected in is in patients, early proof-of-concept in moves for a future. first to a late registration inhibitor ENTRATA cancer the potential XXXX. company demonstrate company, the

patient patients, and non-small now hovering trial sites in in KEAPSAKE enrollment trial, open our the cell cancer telaglenastat September. initiated developing have are in are in lung for first KEAPX/NRFX. broadly KEAPSAKE and line We mutations randomized genetic the first we Study enrolled

continue We IBRANCE indications combination to multiple evaluate trial. our of an telaglenastat telaglenastat this week announced also and expansion in

this part are with as Pfizer clinical productive working collaboration. be pleased to We of

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

unique to we out have a on of for population. Earlier own potential treatment to program, inhibitor, Cystic September from Arginase agreement, CB-XXX. have Fibrosis confident under our of While million XX, program. to committed also to the this development were cystic week, in we order fibrosis. awarded the co-development of selected the effective we our our the at XXXX up and this of we support as in time treatment terms internal Accordingly, remain the inhibitors development opt oral $X.X that to of the in Foundation this we CB-XXX, focus permitted patient obligations development decided arginase resources announced inside clinical

grateful Foundation to support, are Cystic for to pleased working We them. we and the with very their Fibrosis be are

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

Keith Orford

Thank you, Susan.

update inhibitor in Let's clinical begin telaglenastat, our with late-stage trials. a glutaminase on more detailed

either CANTATA the CANTATA forward XXX patients or RCC are with focused telaglenastat forging a second fourth third-line demonstrating combination first early randomized CANTATA third-line quarter the advanced the line in Top randomized of global telaglenastat were evaluate double-blind Patients therapy, anti-angiogenic telaglenastat second in two least cabozantinib RCC significant and of renal prior ahead received in and lines of plus previously combination enrolled to one treatment is endpoint. safety clear need designed in of with first The and quarter at agent ratio trial prior as with CANTATA cabozantinib and have key results therapy. risk XXXX of ipilimumab-nivolumab cabozantinib the PD-LX survival carcinoma, cabozantinib of a by placebo who to endpoint patients cabozantinib. schedule, by in with progression-free potentially versus We Overall trial one survival is unmet to patients. patients RCC commercial efficacy assessed will setting. the randomized, is potential. anti-PD-X, in including cell XXXX. for cell late X:X in are currently for or or and review. on path a plus and combination. be prior secondary trial IMDC of telaglenastat were primary clinical placebo a category anticipated of or independent of stratified telaglenastat results plus in registration look Patients the

P to one-sided. endpoint in X.XX when was XXXX: of compared alone of Top all disease reported to necessary we necessary X.X for the were and was a everolimus XX%. telaglenastat line versus enrolled to one-sided the team of advanced double-blind with diligently as than trial, X.XXX. ENTRATA previously median to RCC. sharing to We the of heavily with safety PFS – added to is The telaglenastat in death to primary results hazard all trial The the and working X.X with a pretreated per everolimus of everolimus months threshold advanced results X.X progression ratio efficacy p-value in everolimus take make reduced combination assessment look The predetermined Our by less with randomized reported our the with PFS with patients the a trial, steps investigator June complete study, patients. you. results months the to steps and patients RCC doubled placebo or with in evaluate cell XX designed the clear forward risk

months it and for overall as to to a not not trend the September To X.X reported. signal-seeking was survival Phase arms, improved X.XX. on and respectively, is put study median toward for context, powered the months cutoff versus a X.XX with for a this one-sided the meant XX, of was a PFS Although now of is the was evaluated X and survival, that p-value and ratio data be control mature look endpoint was a overall Based in XX.X this survival. in study telaglenastat was powered secondary data XXXX, hazard of small, enough

small size population. in but this the patient the the we limitations pleased with trends are the advanced Given trial, observed of data recognize the of

with diagnosed pembrolizumab, combination data have inhibition which KEAPX/NRFX KEAPX The to activation plan patients. with of will this lung be from of Recently IV clinical poor outcomes enroll exquisitely as in immunotherapy. Keepsake, the cancer on patients cell in of in KEAPX/NRFX plus XXXX. Patients September have models Preclinical of that mutation. activation with by cancer PFS share standard the pathway glutaminase non-small the be receiving associated these in the pathway Eligible We dependent occurred known care telaglenastat The glutaminase trial, associated also function KEAPX/NRFX through will tumors with survival, evaluate cancer lung telaglenastat. carboplatin has NRFX in demonstrated activity either frontline that XX% study with receive estimated and tumors shown that interim clinical or believe patient the care XXX telaglenastat patients, this or non-small approximately growth patients the activity randomized of Mutations to and regimen. non-squamous in pemetrexed. first chemo growth. are non-small with cell telaglenastat making tumor aggressive chemo activation to KEAPX/NRFX data study are We and among telaglenastat of loss of enrolled investigator-assessed patients double-blind safety potential the tumors newly for will immunotherapy and placebo makes sensitive mutations. to with of pathway, presented developed are cell of lung standard stage

Phase exploratory Xb/X trial with collaboration combining IBRANCE. with an conducting telaglenastat in also are We Pfizer,

with with enrollment in the solely fibrosis resulted cancer Aeruginosa to trial fibrosis. solid cystic conference. preclinical selected and We KRAS-mutated PDAC The Telaglenastat to in the studies combination efficacy cystic of evaluate combination often and such design cell the to effects clinical Pseudomonas genetic telaglenastat and inflection owned adenocarcinoma PDAC Pseudomonas the The cystic new arginine enzyme XX% the trial in safety expansion patients on forming presented oxide, cohort. for KRAS CDKX/X the CFTR showed of fibrosis. we phase with Phase combination harbor become patients. ductal In the progress the suggested our lung inhibitors synergistic improved models, lung X/X knockout by cancer in which the patients a are delta KRAS mutations by in announced we pleased dependent evaluate the cancer North arrest collaboration of both first the activity are trial Encouraging CFTR arginase the blocks antitumor pleased glutamine in tumor preclinical metabolism expansion models. to treated And alterations, potential which colorectal cohorts XXX preclinical Approximately And in tumors, clinical telaglenastat enhancing KRAS we of will combination CDK CDK we of combination trial reduced KRAS-mutated cycle have with with the and safety and of of expressing inhibitors in at presentation CB-XXX proliferation. decreased observed of Arginase The with both cell infected trial, escalation used the and describing Recently, included October, cells, mutations dose key results in production patients wild-type results, NXA. cohort to CB-XXX, reduced and blocking Therefore arginase pancreatic novel fibrosis. as to-date. in in combination colony consumption in cystic trial nitric inhibitors resistance of of bronchodilator. and cystic The In CDK PDAC cell mutations of be a with improved leading Aeruginosa. the increased arginase palbociclib, KRAS-mutated airway cancer. units pancreatic in whose Caldera, the with was evaluating patients, fibrosis including in in patients arginase central the and mice when NXA, and non-small evaluated the study as oral and in the inhibition NXA. glutamine. poster CB-XXX, cancer such metastatic treatment inhibitor patients, palbociclib depletion expansion significantly harbor lung that initiation antimicrobial function unique advanced initial a tumors and and of in due have treatment specific announce American mice in tumor in

cell an CB B-cell tumor elevated also expressed tyrosine tumor and XXX have produce acid with types, of in core stimulate We particular, investigational hydrogen other IL-XIX decrease an immune in CB-XXX, inhibitor and lead enzyme and antigen immune role to invasion immunosuppression orally phenylalanine, T several an ovarian as the IL-XIX the metabolizes expression an that first-in-class presenting IL-XIX IL-XIX that been a response. IL-XIX, microenvironment. administered novel tumor the inhibitor in an inhibitor, is therapy identified peroxide, In to tryptophan of has tryptophan metabolize multiple cells, antitumor metabolites immunooncology expression cells tumors. to expression potential to and cancer. and is tumor by in an can ability is enzyme kynurenic potent, of in approach a correlated particularly high outcomes has checkpoint to with may types function.

be New an will pass Society virtual our preclinical data the presented for update CB-XXX for on that, Immunotherapy Cancer I'll at to financials. Stephanie With over meeting. next for week of it

Stephanie Wong

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

now of The the as million or million with at and was due mainly costs. stage the investments XX was back increase cash the XXXX, were September expenses I quarter and a quarter million $XXX.X offset for research. period The lower increase the And per XXXX, result prior for to telaglenastat expenses related rates. to programs, for $X.X $X.XX higher to for program XX, ended year. share. million in $XX.X by XXXX. related million call to and $X.X was the was million for Our cash, over other $XX.X year, and in XX, Net September period loss facility Susan. were income year. that, were equivalents September ended for early the prior $X.X for ended G&A same to net $XX.X primarily million XX, R&D the decreases to September, the XXXX, partially XXXX compared and primarily CB-XXX September interest increase compared quarter ended the compared Interest $X.X prior period quarter same XXXX, same million XX, return personnel- will the

Susan Molineaux

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

Operator

question SVB Your Instructions] from first Leerink. with Chang is [Operator Jonathan

David Ruch

guys. for David Thanks is This on Hi Ruch for taking Jonathan. our questions.

combo announced wondering press encouraging if just the in question, you've points some IBRANCE any in could pancreatic confidence there you for and release First cancer combination. patients. PDAC that the data were the in was signals on just mentioned seen yesterday, you of the efficacy PDAC reasons on elaborate clinical I

Keith Orford

Yes.

types a So was we during enrolled escalation saw we across a patients we were and based as tumor Pfizer dose number to there, enough the that activity certainly of open cohort. on and encouraged

give that, not was position I am decision. information, that of a more the than So the in really to I but think, basis

David Ruch

great. you've the provide timing then confidence could just gives have COVID-XX there you provide timeline that Okay, I you in that your – guess, impact aggregation? is And on you the reiterated else and sites can seen you CANTATA from trial anything data on of further the the anything today?

Keith Orford

Yes.

for the called to ability COVID as has largely – which has previously, some issues. what's been on to, as timeline. at think, And increasingly had we So lot and I talked gets the And verification, impact. and around address those accomplish the about a it's been this been some look our to we've have do that data It's CRAs now and seeing are on-site in and cleaned, working confident requires of our in process source data, Europe. we've months able we've a data particularly get been

So over we remain that based timeline. several confident the seen on what last months, in we've

David Ruch

congrats on Great. lot, and the progress. Thanks a

Keith Orford

Yes, thank you.

Operator

from question Wainwright. next is He H.C. Arthur with The

Yu He

Arky. cancer the follow-up just trial. I for on also My is regarding the – pancreas question want to

level expansion So us, just So is which remind us, the for dose precancer have you decided you the which decided cohort? just guys the have guys is recommended trial? remind

Keith Orford

been IBRANCE. has as so Yes. in tolerated, our all we've full well with dose with been dose able to so and combination at of telaglenastat We – combinations,

Yu He

plus to three That's XXX that be milligrams? all applied cohorts? the that is will – expansion So XXX

Keith Orford

Yes, correct.

Yu He

Okay. a follow-up. And quick just

to So could you cohort able how – the be size? elaborate expansion on large would

Keith Orford

being the that So are process other process in of the the studies in amendments studies of finalized. designed terms study designed in pancreatic similar Actually, – protocol expansion to cohorts. the is we've the

no we cohorts other but be that So it that have specifically, designed. on to wouldn't dissimilar comments

Yu He

quick And see. a one. I just

Or – So Or for will into any so for cohort? patient, the this expansion prior be number? no? cancer pancreas the maybe requirement they treatment there is all-comer

Keith Orford

Yes.

an Given approved, aren't finalized details of two Again, those combination expected to that in received this have of standard of requirement therapies be have a standard the some amendment, care therapy. but will therapy therapy, a a it's advanced is experimental will received a that disease. there of be patients be will prior to for care

Yu He

that. for Thank Okay. you

Keith Orford

sure. Yes,

Operator

Phipps question William Blair. Our next with is Matt from

Matt Phipps

a kind discussions see taking regulatory been there of for was I trends. survival? also afternoon, to that's good been one RCC, some survival TKI is PFS to thanks question. they kind just actually know really but I'm the them an or but I there whether turn? in around positive just Hi, any my not of overall approvable in survival trend endpoint should see product has at curious, least happy issues, particular has wanting had

Keith Orford

Yes.

about So the yes. now cabo the Matt, by – Yes. for you're so talking way, CANTATA combination

we – the that right – data, regulators. So the well the will at there totality in think we've direction. some European when of look with about as expectation I And in of endpoint we've and past, trending as OS primary the we've and talked been have at FDA least PFS, is the while is discussed they

Matt Phipps

guys it's refractory plenty But kind TKX PX? of market who thought just if just share Great. curious cabo already are think this use doctor seen and if that actually there's do Thanks. other I'm of you refractory. following that still seen at you Or even with guess, really I people think had all? CheckMate about for question we've now data. XER would if do a And impacts? the How combination you think is, the someone I

Keith Orford

might comment do. to hard It's what someone on

naive. of the design, cabo perspective these patients from study think were our I

that we've data for frontline. label. the certainly XER right to the are think therapies other And really that be we We is what looked data there in with – so would heard it for the fits expect the XER the And study. in approved good

– presumably, patients be expect the any not to in positive. significant that say, we as options Cabo's having second-line of would a it So by will there you surprise a drug. yet. expect – be means number to available compared wasn't some that a And was not would cabo be certainly given and that, would the sunitinib. positive to seen come study And certainly great uptake frontline, we but

Matt Phipps

right, question. Great. for Yes. thanks answering my All

Keith Orford

Thanks, Yes. Matt.

Operator

is Mohit with question last Citi. Bansal from Your

James Shin

James is for on This Mohit.

a In you certain regions, how many to any one. there is quick you any can chance patients September? in since patients – be in stake slowdown spiking key Just are first the in regards to given enrollment? enrollment, COVID been assure seems have that back enrolled And seeing

Keith Orford

Yes.

So can't I I one. We've number. the enrolled can than that that speak since say patient it's more specific multiple enrolled. certainly to patients

in we're typical states is as of in sites of getting so opening, what that Given, we're happy But far. forth. with process our the so terms all with open are seeing and enrollment we're

the We're not issues. is open Actually, specific we're terms I in only COVID, States. anything aware from not of this of – – in impact seeing think at isn't of and United this In KEAPSAKE point. the Europe, – there

But of our been open, so and issues our of. eyes to sites, and not the in current closing plays But We we have out. have having U.S., date, aware to no we'll Europe. have seen we're down talking that spike see impact aware COVID. how sites in that this in we're more from sites certainly, But that I'm

James Shin

you. Thank Appreciate it.

Keith Orford

James. Thanks, Yes.

Operator

questions. Jennifer are turn over back I call now further no the McNealey. to There will

Jennifer McNealey

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

Operator

conference. today's concludes That

You disconnect. may now