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CALA Calithera Biosciences

Participants
Stephanie Wong Chief Financial Officer
Susan Molineaux Founder, President & Chief Executive Officer
Emil Kuriakose Chief Medical Officer
Roger Song Jefferies
Nick Abbott Wells Fargo
Call transcript
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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Calithera Biosciences Third Quarter 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 over to your speaker today, Stephanie Wong. Thank you. am. Ma' ahead go Please

Stephanie Wong

Thank you, quarter to third everyone. Good conference call. afternoon, XXXX Welcome our operator.

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

in remind plans of you XXXX. about we prospects that of discussion our Risk Private Before like begin, filings Act statements a statements expectations, from would 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 I 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.

Susan Molineaux

could in next welcome excited Chief this We today Emil. Thanks, this and later Medical special you Emil third to he our on not will us new on to XXXX be who embark Stephanie. role quarter with in everyone be call. is joining Officer. his as afternoon, a today Good for joining more call. Kuriakose, chapter conference And thank presenting And us

Takeda. pipeline chapter, strengthened Speaking and last with from Mivavotinib month, oncology we of acquisition of the Sapanisertib the precision our next

squamous NRF a the KEAPX potential mechanism treatment mTORC for which reminder, X/X cancer. key mutated a is cell Sapanisertib NRFX first the lung to non-small targets that and be mutated a As inhibitor tumors, dual survival has

the X well-tolerated We with well as generation refractory Phase tumors X TORC lymphoma, harbor Sapanisertib provides clinical is first cancer single inhibitor, X patients Sapanisertib profile. Phase and non-Hodgkin's of non-small Mivavotinib NRFX the TORC and of safety dual sick relapsed complexes initiate or studies in with NHL refractory in studies. demonstrated completed patients shown a the market and squamous inhibitor next DLBCL a to potential activity CDXX and first mutated durable inhibition MyDXX lung patients to X to cell with Mivavotinib in responses compelling single for a with XXXX. As in therapy plan as Mivavotinib has of has agent quarter both benefit mutations. relapsed II and whose the best-in-class the be TORC agent drug and

the trial Additionally, an last of week, following to decision we discontinue XX telaglenastat of announced analysis interim and cell KEAPSAKE non-squamous non-small the cancer patients. lung

and robust cell no difficult for development CB-XXX large We Mivavotinib continue cancers, to and and Fibrosis with interim squamous Sapanisertib in of advancements to have diffuse time. telaglenastat Phase the this Cystic lung and the therapies showed treat at defined internally arginase effects. American In We presented targeted at data of CB-XXX developing to pharmacodynamic presentation, committed of patients B-cell Last cancer our we reported study plans both biomarker populations related from remain non-small with the the dose was we respectively. linear lymphoma Conference, Xb tolerated pharmacokinetics week the inhibitor. of North the oral well

rational proposed data our found can treating as be biomarkers, we chloride. mechanism trends in poster Additionally, encouraging on saw a approach sweat increased website. exhaled current substantiates and nitric fractional including oxide FeNo CF. decreased disease for or the The The

Head and have we Friday, Vice CMO. President to succeed Clinical of Finally, on as Orford we closed Emil Development promoted as Keith from Kuriakose,

four addition, this to the of addition years Keith the to has been to of have our a I Keith. his on last we to XXXX, for Calithera, Directors ahead. year an we team thank part of would acquisition strengthened congratulate forward take Emil been to Emil like with team seven and to the enter of out assets. the was opportunity and prepare last exciting In times promotion. we and his Board these our of contributions over for years, and that Sapanisertib a Mivavotinib integral transformational evaluated diligence has prior part XXXX close for our look This as

new X focus studies in two initiate We highly will and on of compelling keen the our progress. begin to a will And you Emil the updating forward programs. with for oncology, development first details plan precision Mivavotinib Sapanisertib clinical New clinical and on to We Phase the on quarter, call Year I that, the over programs. our all of additional with to and pass look

Emil Kuriakose

showed XX ongoing study and to CB-XXX with several demonstrated epithelial CB-XXX subjects function last honored in CB-XXX in adults oxide these fibrosis. or oral Board increases for is XXX broad thrilled every on completed oxide pharmacodynamic CFTR receiving American the XX trend in including which subjects safety treated CMO showed data and subjects Thank robust positive start fractional XXX role CD-XXX providing mg, genotypes, on is at driver rapid production. the the leadership across plasma several inhibition six dose cells. placebo. with our by mg was some decreasing nitric a reported and partnership for my CB-XXX in gratitude a treatment which dose thank Susan substantiate CFTR profile CF. CFTR levels CB-XXX the of subject, around demonstrated Complete ivacaftor dose towards all inhibitor the Keith continue trend human arginine, Directors. non-sense placebo first you b.i.d. discontinuation, for in a subjects previous function mechanistic mg preclinical I'd volume subjects last in I'm nitric a of to consistent were you, happy NCF express Xb pharmacodynamic mg, our Notably, of changes update to clinical and kind CF. rationale These week going to Together showing Increased to additional spectrum on interruptions versus dose pooled with three meeting want therapy treated Kalydeco. the mentorship arginase airway three a accept biomarker exhaled safety XX words. across second, subjects XX% achieved comprised levels, exposure a mutations. Last like overall CB-XXX. NO pharmacokinetics showing data or without Conference, in on CF in data continuous bronchial forward an at for were of The forced the significant a novel treatment with programs premature or cystic with of presented to proportionately the to by of over with assessing proportional linear FEVX and a receiving of XX key with we week for the look the the today and modulator receiving endpoint you detail population arginase in enhances his all or reflected increase CB-XXX plasma joined and and already CB-XXX of trial one well-tolerated marker enrolled increasing production inhibition and had first dose XXX with we in expiratory effects was chloride, analysis be presented FeNo compared all I'm North and years. and the CFTR I'm in months. of sincere the Phase plasma to with target treatment placebo. or trend escalation also today the the and truly above. data XX over you that Sweat forward dose. next and to FEVX

wild Turning or monotherapy programs, will refractory data cell first of Phase Stephanie a quarter we to in plan harboring the of that, cancer. XXXX the financial. of study monotherapy and mutation course a and our XX an lung inhibitor KEAPX relapsed quarter will or of Sapanisertib cancer non-small with interested evaluated initiate initiation newly intended strengthen or with study XXXX, over as to in or populations of that next further the and DLBCL a these the without patients SYK I'll acquired squamous defined lung activity specific on plan squamous to in we both data X start existing biomarker first cell Also from to as the mutated KEAPX we're molecules type of efficacy NFRX in Mivavotinib MyDXX with the cancer in-patients cell Phase With on and in. NRFX refractory update the of and relapsed lung the and it The CDXX in X monotherapy to months DLBCL studies inform non-small these generated pass the over that trials are XX to be both support our registrational that mutation. for non-small

Stephanie Wong

The in Detailed of on $X.X XXXX the XXXX, the was decreases Thank payments $XX.X to ended and XX.XX $XX.X the programs was in upfront legal represents I Cash XXXX early stage $X.X $X.X million were financial after three were in expenses by were primarily good $XX.X in the Revenue XX, expenses. for our third September XXXX expenses XXXX at increase investments million and and quarter XXXX. October. this million in [indiscernible] inside review telaglenastat will in million results research. third was you, primarily million. for of related call. Emil, million received loss afternoon included R&D September quarter quarter totaled The to today's investments decrease compared cash driven results everyone. September for of months increased by the XX, quarter release. Net current agreement. quarter our third G&A in the under was briefly payment press $XX.X to $XX.X in million and third XXXX. offset collaboration in partially milestone the million compared the

of savings this study we million. KEAPSAKE $XX between during data million in As mentioned scheme KEAPSAKE the and the result on to cost expect call $XX Friday, with continuation

with our now our the into XXXX. call to also investments be and meet will cash return We expect that, sufficient operating current And I'll to Susan. back plan

Susan Molineaux

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

Operator

Instructions]. [Operator

the from Roger line Jefferies. comes question first Song of from Your

now open. Your is line

Roger Song

Great, thank the couple for from you question. taking me. A

for assets. one Would better property MOA targeted two kind to additional first and potential the Phase new so is, characterize preclinical work or mechanistic best-in-class two unique an besides of indications? conduct for X those The the plan you the in the the

Susan Molineaux

Emil.

Emil Kuriakose

compelling is molecules, I these think populations. of key in for the I Sure, terms the yes, thanks single they is both specific both in the agent question. would fact so and clinical the think activity for already yes, that have I these that of demonstrated the Yes, data sense are of mechanism been pathway the or the is there CDXXb. for reports inhibitor that answer theme characterized say clear There the terms both cell signal in mechanistic lung connection that's lymphoma have much been studied probably between in NRFX and fact that overall squamous non-small the well it's sick transduction and a specifically. the well MyDXX the on in published TORCXX, in

mechanism squama. exact the activation the of of rationale, upregulated in in there's activated are not clearly Although is TORCXX known. the supporting But context and that details NRFX

mechanism regard, we I will also that well. that. fact do to running and allows hypotheses But us collaborate that characterization the of work we're work trial a yes, translational clinical the some using in that as So further and do think

Roger Song

maybe That's great. for data. the just comments. And the CF for Thanks

for So be understand data will you for to program? X key of for make Phase the go/no-go kind there looking initial Phase promising what X maybe decision just are you from elements have CF -- the data,

Emil Kuriakose

No, great question.

from So are very the in standpoint, the in direction. well where are lastly, headed PD from it's very a has the all data And pharmacodynamic safety a the effect, very profile. molecule think nicely. far they're so standpoint, of these And that the behaving key encouraging downstream biomarker tolerated right PK I a biomarkers

So I corroborated the the far rationale, is so by mechanistic think data.

the current per XXX enrolling expected obviously, go continuing another steps, milligrams dose option dose escalation dose end next another the to a as go design. X far protocol, Per is cohort, escalation, year. of which to As complete by is the the have cohort we're dose up we the level, to level, and

would and range robust option safe in a so the PK and the safety, and potentially in efficacy think, dose therapeutic the more And get and molecule pick Once where the PK we PD for to to full dose the want full doses a idea define more And XX dose they're a characterization next would do we is dose of do days duration that, what the have step biomarker. development. fashion. type to where and profile increase would of finding entire be we from study terms dose to we we escalation both at the order define in look be PD

that would step that be next would be the So planned.

Roger Song

Got it.

full the start at the necessary mostly will the next So and PD the and environment the data the -- for looking for safety not development? efficacy full to the for the you PK efficacy step for

Emil Kuriakose

Correct.

Roger Song

got Okay, it.

internal with Okay. Maybe discover I can is the tell focus question. discovery? compounds. synergy that Susan one previous or Maybe the lethality contaminate think some discovery you history synthetic platform. just also of just the pathway, us to kind mentioned, last of -- you any about tried And metabolism what

Susan Molineaux

problem. no Sure,

in really from genes. series are lethality synthetic be at metabolism. and our paralog So, metabolism We've a looked to whole specifically away designed moved of not targets

in pairs genes of gene activity is inhibition other interested deleted of basis where the one in the a tumor targeting we're drug. of So gene and the the is for

so started. play And drug to roles ranged where that in, just in biomarker Sapanisertib Mivavotinib specific really And important populations. where it's defined the and we've that brought we pathways, pretty puts signal clear it that example, transduction we've important they are from for far and in more

then it is without Gene can't you gene they're have Gene Gene like down and it's is A. boiling the B missing, that related tumor know survive Gene you very B. paralog simplest case, and inhibit A Gene So you and to have If you A,

So some where gone we're to in discuss we showing that's some in and expect of targets basis the we've lethality XXXX. the for where synthetic of

Roger Song

very Got it. That's helpful.

taking Okay, my so for that's questions. all from you me. Thank

Susan Molineaux

you. Thank

Emil Kuriakose

Thank you.

Operator

from Your next Fargo. line of Wells Nick the Abbott comes question from

Your line is now open.

Nick Abbott

Thanks you from reported to with, my Great, start go maybe XXX milligrams. last you. milligrams, dosing questions, week but off at was milligrams to plan couple to taking on think a the data original thank for was I XXX CB-XXX XXX the

XXX So the continuous what XXX and hope arginase achieve that reported or what by plasma rationale above XXX? higher, milligram go going to you to was of you given do to division

Emil Kuriakose

Great, great question.

think two So that's question. I a part

to regard straight any were instead haven't to And the thought in top it XXX that go best we we safety to task, approach data the target going to in by called urinotic I could DLTs not marker relevant better profile. you which this with being decision to granular, urea study, just the are the gives it inhibition And And the XXX, the do together was inhibition PD we is rather characterization on of that's opportunity more two related, driven disruption we in order in while XXX of steps. end to the than range, at this nonlinear committee to key of sort despite clinically seen fact preclinically granular dose PK So better be also steps a have that idea of better more we acid that two decided by, cycle and primarily urea cycle have think one. or that the profile. monitoring would seen that which get to the the that's that measured

The the target main that we two thinking was that arginine second production, and are okay. dose see that than inhibition as related up the go doesn't saturating second that is the question continue is, the up of drive the to to With the reason there's effect around where So occurring regard reasons. the plasma reason as expected is higher as could as you're long production, you go target we're doses is in airways. arginine above see And go inhibition inhibition? given within plasma decided driver key And to plasma. we improvements One your in to increases you translate but why full to even long getting that regard where to necessarily PD NO Arginine the your reason safety to dose is with is, then XXX continue XXX.

sure driving And target at to by reflection of so a site we're lung. trends that's reflected in levels up you is is and that the in of FeNO which the airways the need that within of seeing higher doses make is assumption might the you're doses, inhibition that that higher achieved arginine fact the systemic action

the targeting. other so we're thing that's And

Nick Abbott

All right, the so on as FeNO? that, do a you you know, think following you would just up on see I of think effect plateau

Emil Kuriakose

know don't to good answer the a that we if question. That's yet. I know

these that normal at baseline has lower diminished baseline know NO we are so, the And production, patients their population. than FeNO's

a it's going are and know, we seeing has wide variable FeNO a up trend And readout. highly clearly dynamic And so FeNO you range. also in

don't I again, know that, that. get I think on answer successfully. we the we more think to continued could data But So as we

Nick Abbott

trial, sputum say then to Okay. anything burden say collection I by affected COVID we'll was in but in able there can And of patients? know these is this you about microbial be

Emil Kuriakose

a that's an colonization, question. by of quantitative was has relatively sputum fact level patients. impacted were that it looking exploratory on yield sputum study endpoint. enrolling great think at induced been a we of there during site And in have collection these And COVID. the the I do And the had, we Yes, lot primarily restrictions samples was poor,

you the with the as do the function. airway eliminate a reflection well. benefits anti-microbial, is But data FEVX what's in positive that level of again, FeNO have we're the number trend reflective reduce mechanism there. you in airway in one, not sputum when fact see we trend is of a even that, to do that's unfortunately, the inflammation, I regard so with And And the seeing pathogens think and being benefit primarily of and

the right encouraged So direction. we're heading we're the by that all the seeing biomarkers fact

Nick Abbott

quick new on the maybe questions program. then and Okay, couple of a

think NRFX a then sorry, continue KEAP. and evaluate you the to mentioned I'm understood to KEAPX evaluate, and NRFX Sapanisertib the trial, also So it continue I but

So are those two separate cohorts trials? separate two

Emil Kuriakose

two they're No, separate.

look the the is a also so moderate and the good signal differentiated evaluate those pretty that individually, compelling, a was in KEAPX from question the at response. so on So as same And in there groups here of NRFX type evidence the patients separately idea want can look and wild CTEP the in data that and study. look we'll patients we NRFX also have that study population already separately, at KEAPX signal have one whether number completed, was separate we at

So of this the in we'll those looking be context of study. all at

Nick Abbott

at great. mutations, tend looking in who patients MyDXX, to triple-hit mutations have double type have genetic And Mivavotinib, at those do lymphoma? in other mutations with co-occur in those those who patients you're split that just Okay, And evenly. XX wild then and relation to don't or or be abnormalities will

Emil Kuriakose

there's think question, Great, the be dosing we answer because the yes, is will we probability data first data. one, at number response looking cohorts trends the in subsidy the outside in idea is first potentially single equal within that two data early a the so number question that there's for agent separate well of show that already clinical signal as indicating existing preclinical XX of an and MyDXX mutational as even strong across increased both mutation. the And

with And so to that mutation? you can with think, mutations, just repeat question, your I specifically regard co sorry, second question to co regards second

Nick Abbott

co because double so. mutation Yes, lymphomas hear we and triple-hit often exactly, about and

Emil Kuriakose

with not so a Great, phenotype. strongly double CDXX hit do the MyDXX, overlap yes,

origin the on in the predominantly for are data. classification, GCB MyDXX, cell that's the whereas ABC overlap, in part there's and classification, lymphomas very based so little published the most double-hit published of the So CDXX

Nick Abbott

much. Okay, you very terrific. Thank

Emil Kuriakose

Sure.

Operator

to the would Susan questions time. I'm at to turn no further back Molineaux. I conference showing like now this

Susan Molineaux

all evening. us and a good operator for Have you, joining Thank thanks today.

Operator

participation. This today's Thank conference all you call. your concludes for

now disconnect. may You