Calithera Biosciences (CALA) 9 May 202020 Q1 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the Calithera Biosciences First Quarter 2020 Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers’ presentation, there will be a question and answer session. [Operator Instructions]

I would now like to hand the conference over to your speaker today, Ms. McNealey. Jennifer

begin. may You

Good call. Welcome Christie. quarter our XXXX conference afternoon, you, to everyone. first Thank

today Susan Stephanie me Orford, President Joining 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

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

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

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

turn over the with And I'll that, to Susan. call

families like everyone. I'd Thanks, healthy, to XXXX on while our say, pandemic. conference of for hope Jennifer. first remain Good the And team, the joining challenges we afternoon, you quarter the the of call. you thank us your and entire COVID-XX today world On addresses that behalf

CBC, now all in of for County and has this homes our we compliance California practice as San guidelines weeks are on Mateo our number from State guidelines. call, Today, with the working a been

as coordinating ongoing going can We activities we our forward soon do on-site our business We to operations. operations safely. so maintain as diligently are back to look to

treatment small immune develops of drugs, At metabolism pathways integrated are company molecule the and tumor are for cell other diseases. novel Calithera, building an targeting that biotechnology that cancer and oncometabolism we drugs

By impact are product novel pipeline commercialization. drive candidates, to opportunities positively outcomes building clinical patients towards of and we a programs therapeutic for creating multiple development

We into the first in and including activity ENTRATA carcinoma activity of in are glutaminase clinical in to the a for selective proof-of-concept the trial. patients our renal cancer company telaglenastat take first inhibitor the to clinic cell demonstrate randomized

from We a enrolled carcinoma have top-line enrolled cell with XXXX. us potential patients. that advised a The renal fully safety and CANTATA was data step company. in in This the moves that the becoming second to of telaglenastat half trial, efficacy October we And study closer commercial the at in to plan time trial trial biotechnology report fully CANTATA we a registration XXXX.

In Along with by that to COVID-XX, expected guidance for light April affirming monitoring. sites, additional allows fourth time of end data top-line the quarter associated the with in updated in is our activities data visits of clinical expect to including we XXXX. that XXXX, require readout the of delays guidance updated for the

mutations progress quarter, non-small trial line survival standard-of-care present in pathway cell patients and resistance the patients lung KEAPX/NRFX XX% NRF therapy. initiating non-small associated cancer randomized this cell made genetic cancer is with first KEAP. in in also tumors of lung with continued core harboring approximately we In of mutation or A towards in a is and

glutaminase reliance to this inhibition and telaglenastat. glutaminase leads upon to pathway of Activation activity of sensitize itself

of clinical we current of the associated in during COVID-XX study Given enrollment stage to the expect the third XXXX. new opening the with challenges quarter pandemic, begin

trial plan data design accepted abstract the progress in of from to interim Virtual describing the XXXX. XXXX for presentation Oncology study and this A has Society of trial We American at been Clinical Meeting. present

microenvironment. for At by providing activity compound inhibition or INCBXXXXXX XXXX expressed first proof-of-concept immune is to Meeting were the an demonstrating this fall, ESMO enter inhibitor arginase the inhibitor, clinic. and the immunosuppressive Arginase tumor last presented, arginase enzyme for cancer. is arginase the Our efficacy for of first cells the the data in treatment

We continue collaboration and Incyte for clinical first-in-class partner, seek our the solid types we program develop of product to in pleased of tumors. with continue to as this with with are a trials progress multiple patients

agreement. of not against has the this failure matter for to County, at the at Calithera milestone comment plan payments certain pay under further filed California, time. complaint as a Incyte's company Superior are Incyte Court due claims to of in San two Francisco We arising the do on this breach believes contract

been potential remain in not inhibitors The impacted timeline of as the by program for the of from and filing complaint. before cystic treatment clinical the have Arginase the have the trial also fibrosis.

for selected have a the inhibitor It Calithera. inhibitor of unique treatment that is solely a owned we patients. fibrosis CB-XXX, oral by arginase novel is oral arginase cystic Accordingly,

single tolerability We safety, pharmacokinetics CB-XXX the have Phase completed dose and a in I of to evaluate ascending trial volunteers. healthy profile oral

with in further in begin. people are poised fibrosis openings pulling the b the to and development cystic of Our enrollment patient I we progress COVID-XX Phase situation. quarter first is Site study XXXX, of in expect the in clinical third

pipeline Beyond in team. potential need. remain R&D be new differentiated with clinical-stage on We of a we our highly programs, focused three producing areas to novel candidates therapies the have and a broad drug productive unmet

call on over pass our that, the for to details I clinical additional progress. Keith With will

Thank you, Susan.

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

clinical cell potentially We are focused commercial for and currently carcinoma. telaglenastat renal path on in forging a

of we of with trial in patients. combination a In RCC CANTATA, October double-blind completion enrollment announced randomized, second and third-line XXXX, global, cabozantinib telaglenastat in of

RCC for settings. advanced is efficacy and in evaluate versus patients who the prior significant including the to ipilimumab CANTATA anti-angiogenic patients clear two and nivolumab prior cabozantinib have agent designed CANTATA enrolled cabozantinib in cell safety XXX combination of one in combination. placebo of received telaglenastat or least at patients unmet plus schedule, third-line one the ahead the previously second RCC with therapy, lines or of need demonstrating

be category telaglenastat either were ratio survival and PD-LX therapy. plus treatment assessed to a independent progression-free X-to-X will plus primary The prior by survival key cabozantinib anti-PD-X, as a with an risk in or endpoint. a by secondary randomized cabozantinib. endpoint review. is Patients IMDC placebo were Patients Overall stratified

to We at have centers order and study including clinical performed sites, facilitate required assessments receive reduce visits local to larger if facilitate with allocation to made patients schedule allowing to of pandemic, a conduct study study the in to the the during compliance have to clinical of accommodations number drug necessary. of scans

expect to the to of has trial registrational XXXX. and CANTATA potential top-line The the report trial fourth we in a of results as serve quarter

NRFX/KEAPX in also We believe has with patients mutations. telaglenastat to be developed potential the

function gain of function through or that mutation a models Multiple spread. KEAPX mutations in accelerates demonstrated this have vivo of preclinical pathway formation NRFX and activation tumor of loss

In inhibition NRFX/KEAPX aggressive, addition telaglenastat. the activation glutaminase them makes to to the making of the tumor by activity sensitive of also models more pathway

chemotherapy Recently patients demonstrated cell have standard-of-care receiving non-small clinical frontline in lung of chemoimmunotherapy. presented activation the that NRFX/KEAPX data outcomes cancer poor results pathway very or in

in of the to Mutations non-squamous unmet designed in quarter KEAPX/NRFX are in pathway non-small need third a of in begin we the randomized cancers. which this approximately trial have Based in present XX% population, lung XXXX. on we expect the patients, cell lung cancer

in period KEAPX lung the and survival. evaluate and approximately are XXX cancer standard-of-care will in endpoints in mutations either include NRFX. therapy, metastatic cell co-primary an safety plus or study that pembro, harbor The non-small The first-line investigator-assessed patients non-squamous, with safety study with run-in progression-free will tumors chemo combination telaglenastat initial

describing at design the Oncology of An been progress the is analysis and Society A trial XXXX planned study Meeting. American accepted in abstract Clinical has for Virtual presentation interim XXXX.

have tumors an single-agent in that sponsored NRFX or solid patients with telaglenastat trial, In is currently ongoing. evaluating NCI KEAPX mutations addition,

XXXX. expansion with collaboration but also have TALZENNA to temporarily with conducting second trials paused Dose and been COVID-XX combining are both quarter now We two these Phase been due in of the IBRANCE. escalation Pfizer, completed trials. Dose the in Ib/II to with expect resume exploratory in enrollment situation, we has cohorts telaglenastat of

XXXX, the first-in-class co-commercialization arginase to an known investigational inhibitor XXXX arginase, secreted targeting also enzyme programs. Next, in or T-cell by is cells as suppressor collaboration. checkpoint block in MDSCs inhibitor activation metabolic with an co-development, tumors. developed INCBXXXXXX Incyte myeloid-derived being a immunosuppressive immunooncology is

evaluated not being to therapy. as XXXX of across cohorts different metastatic monotherapy, types as of pembrolizumab well with amenable in patients or local with cancers advanced is as combination eight locally

ESMO presented data September first this were The XXXX. in at study from

regimens. biliary alone with tract and The trial XXXX combination three chemotherapy additional in different gastroesophageal paclitaxel with ongoing. An evaluating XXXX, or gemcitabine/cisplatin daratumumab in colorectal, in second FOLFOX, is treating ongoing cancers. daratumumab multiple clinical patients or also is endometrial, ovarian, patients, trial with patients myeloma plus

to this and program pleased look XXXX forward data the progress we the future. We program updates with in from additional of are the

develop to fibrosis. developing Incyte, rare inhibitors collaboration also in development cystic fibrosis. oncology. disease are we’ve inhibitor novel is outside arginase our including CB-XXX of inhibitor cystic of the with specific agreement in treatment worldwide indications, for retained a rights Under arginase We non-oncology an arginase

has well as in postulated non-oncology turn lungs infiltrates depletes as in critical arginine, a nitric the several secrete of neutrophil their to High fibrosis, neutrophils which high patients other and been levels in diseases. have Arginase play these arginase. of arginase CF activity role cystic pathophysiology depletes oxide.

arginase potent has and hypothesized by proof-of-concept lung activity inhibition a concept NO and trials. previous normal exogenous is patients. levels when patients, can with in NO has to shown or We been improve that CF of improve function antimicrobial oxide Nitric that to function arginine administered CF NO lung CB-XXX and restore supported clinical

approximately to CB-XXX oral evaluate healthy to a will of patients, determine the Phase CB-XXX, in has is in placebo completed. quarter third patients safety, enrollment Phase XX been tolerability in The dose compared and range doses which multiple the to CF A volunteers study trial for Ib adult profile expected CB-XXX. test to of start I successfully safe pharmacokinetic XXXX in CF of clinical clinical

CB-XXX any will study. will placebo with eligible for XX Patients receive CFTR the be days. mutational for Patients status or

lung other safety pulmonary sputum In to NO production, endpoints and microbes. and tolerability, function include will addition

additional will different dose In or XX patients of days optimal II to order CB-XXX. CB-XXX this the placebo, select cohorts a dose-finding planned study, of of in doses for of Phase portion receive

We from including present the Phase Ib For the entire will in plan of continue data CFTR CF, study, existing their to trial XXXX. modulators. therapies this portion for patients

over an I'll financials. Stephanie for to that, With update our on pass it

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

well-capitalized. remains Calithera

shares proceeds us to we cash offering of our X,XXX,XXX believe We equivalents public at were drive million. $XXX.X our XX, clinical April, March enables inflection $XX.X common investments for programs cash, cash XXXX. position of of stock Our meaningful value net a million to approximately points. In completed and

R&D CB-XXX same was the expenses prior the for offset a for and partially in million were period XXXX, primarily program the decrease compared million to an $XX.X an million early-stage ended year. increase program. due quarter telaglenastat the to XXXX of the million research, in by a of $X.X $XX.X XX, program The March million and in $X.X $X.X decrease increase of $X.X in million decrease

were for same expenses G&A and $X.X for to XX, million higher XXXX, period $X.X $X.X primarily services was year. $X.X ended costs. increase March prior the compared related the costs facilities in in The professional higher million million million with quarter

and three was the March $X.X income was months million share. the XXXX for compared three other same XXXX, $X.XX ended period loss million or to the year. $X.X ended for for XX, Interest $XX.X Net million per net, months XX, March prior

that, return I back over to will with And Susan. call the now

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

[Operator Instructions] question Mohit first comes Bansal. from We our have

This Mohit. guys. for Hi James is on

plans seeing question any focus your oral to marketing on affirmation due manufacturing the to Just changes had for has COVID pandemic? you your Also, on, administration? given pipeline to a are you or

want oral if question, do at all? Keith, to that answer you

Hey, of I What was oral. quite about didn't Yes, your question capture the beginning very am question? the sorry, actually, James. I the

given you to was affirmation has your products. pipeline administration I of on more if just focus oral asking COVID

that be administered administered of having would I than were – on Well, a COVID in has been infusions our an for think if along. disruptive that's say been having the to would our around changed focus longer-term orally all drugs go basis. – for that's the has probably been orally Whether context they patients strategy regular sort that, I administered drugs in having less impact, of orally it

general, So, that in has in it’s I context. this am focus helpful certainly provides sure that's and it the longer-term longer-term But not anyway. support our on a impact in our approach it for strategy.

question James, you had Sorry. you Could And a manufacturing. please? it, repeat about

Yes.

thinking are with changed if strategies how changes your COVID of things? or thinking any partnering how about wondering has for Has to marketing? some thrown for are Just you those about you COVID manufacturing

time. at Not this

We for or telaglenastat have no product for arginase drug inhibitor. for issues API or with our the suppliers

as both to backup So goes study time materials, manufacturers, as always we of are right our as feeling well now. good API We, have on. course, strategy increase

So, right yet our where we as have diversify any we we get closer delays. do now, plan But to experienced major manufacture not to commercialization, drugs. we

given states I social degree. studies distancing sooner different seem one Got see to of started Is relatively a that at more, ask of could your protocols chance enrollment loosening it. gets If some than be could certain sort others? there

the mean, taking environment. Well, so sort And I of don't different say, a maybe on from are approaches state-by-state up that are in I question. different taking. I times of and different areas good the local a are know difference that's a are based it’s at different local just perspective, the the on approaches would again, or localities. sites the happening changes loosening – impact

at the approach sites imagine could a in So, that an than New are disease having of haven't you in maybe different area just much sites all. seen York

we – where study, two we be are think, Pfizer that should enrollment, paused to from had enrolling in are up we be open having already hearing said, – said going open study, an quarter. we our we that, this start able ongoing just to sites because that's to combinations So that's able as the we

that's that IRB study forth. requires new And than opening so a and proposition different a review

are in to expect as the Ib And those CF open we study of quarter. opening, mentioned, new study Phase two both studies that in our are the patients, and looking sooner. we studies third plan to that those we KEAPSAKE So, the we we open –

track. so it's those Whether and think so - remain – I on

our I signs sites. life are opening signs, that, and enrolling. now call, So of hearing what to starting from we about would They think I are guess,

start And these the the steps really processes so, to allowed in planning that's next us for studies.

Thanks it. guys. Appreciate

your line Our begin Jonathan comes question. question next from of the Jonathan, Chang. may you

on is Jonathan. for This Barrett team. Hi John

survival Just data? me. if an recall could Back data when mature. wondering data, presented from we that that overall two not yet ENTRATA is I data And whether mature? just that ESMO back you the we and the could – was – you I not questions update in on if was at if or had or see when

Yes.

don't have of this we data point. analysis So, an at the mature

As mature. analysis, the when mature expecting to yet in be it it last or But it, manuscript will does, would of of not be a context and we it the we presenting presentation. was a either

not So, it will to mature. at point, be but this coming, be presented, not ready

strategy. And one on question KEAPX you. Got the

rationale of some been patient and course, this Of on glutaminase for inhibitor you’ve publications a data testing there's population. in presented lot a the solid

on just as not discuss exercise and management population? and your conversations But of an risk this based or work areas any on data glutaminase might you thoughts with in KOLs, concerns why can

What investigators, are kind inhibition. studies. why glutaminase I clinical don't a run have done investigators the our the that, enthusiastic go any and XXX% into our including certainty would very investigators with mean, who preclinical say work studying about I That's the activity. study we is of of we

just And community. the particular there's say, strong finally, unmet throughout on actual the would data, clear - to data, high around makes rationale preclinical mechanistic I has it the the sense one, really understanding broadly based this of but the very enthusiasm then addition strength the on population based this biology. But need both just really in lung the become cancer in good

the So, the focus need. the and discussions been of our just enthusiasm has unmet data main the around huge for

forward to And are looking getting this started. so study they

much. so you Thank Great.

of Next Birchenough. question Jim the from line comes

to you upon? inhibition? about you a what talk to or questions. with sticking to have about are you of add standard-of-care I Could burden the mutation? looking PD-X standard-of-care the couple A study are with for improve current patients KEAPSAKE telaglenastat. progress. the all on and just mutational those lower less talk Or Congrats the maybe guys. Hi guess, they for just could just Do amenable and

Yes, sure.

doesn't for this unique have a population So it. standard-of-cares

get effectively So in plus front-line what the most these chemo for who patients current is the standard-of-care patients pembro get will setting.

pembro – PD-LX Although, approved it's also approved the positive is in alone population.

either of approved them are therapies. So

would chemo say I And what's pembro is the generally. used that being plus

do poor not they is does that times published how is that cause very that of In mechanistic population low. exact PD-LX associated The poorly KEAPX They prognostic well, with totally certainly behave. factor. it's not not this do their of – being that's been necessarily and clear. now terms multiple a

PD-LX a of standard got fairly expression. It's distribution

the And so force. driving that doesn't seem to be

of I there particularly either. TMB, terms of norm it's think in out the not

that no might rationale there So, a provide clue. clear from is that perspective

that just I think cells are the therefore, much the to preclinical stress data patients better oxygen reactive cancer aggressive. these these are suggests at managing more and, generally have that manage

of them you tell will preclinical reason be, know is that's prognostic. there KEAPX investigators. nice patients mechanistic – who And for aggressive. have a these the often They you support poor you that are sense – consistent more good hear door, mutant is patients us And what or because so to of with we when being to kind disease the from walk going in have their data

just biology but it's actually more there is different disease. a So bad clearly about therapy, not overall just prognostic there. aggressive It's factor. an It's about response to

ASCO recognize that so, at in a progressing is do you'd detail study on – randomized Virtual Meeting. And the idea study get trial we'll on the to the patients based But PD-X I the design therapy? look

These No. frontline patients. are

disease. So therapy received prior patients who at not have we're looking for first-line metastatic any

plus to pembro be it. or So on frontline is this The therapy, going top minus telaglenastat. study will again, their of we're plus first standard adding chemo, standard be exposure pembro, to chemo,

it. Got

Okay. maybe And just on then, one CB-XXX.

timeframe Just would capacity something enough benefit the try to assess on to to that Or and FEVX? dose? like optimal of functional looking or assess biomarkers the forced drug, is on more at vital time be a benefit XX-day see you

to would FEVX see improvements. able we No, to be expect

portion FEVX. II the Phase of primary of that be fact, In will XX-day will the be endpoint the study

in CFTR from mean, happened FEVX We I relatively have modulator the quickly. – perspective, improvements certainly,

studies IV it's been they've whether treating there seen have done who happened FEVX them patients, two arginine, and patients weeks. improvements receive, with or well been in even there in And inhaled and proof-of-concept in as have within

And and in weeks, even that within two start able so, our to four weeks be may certainly expectation seeing FEVX is we improvements.

questions for Thanks taking Great. the

Yes, thanks, Jim.

Arthur question the from of line He. Next comes

for taking Thanks guys. This Arthur for RK. Hey is my question.

question a regarding on trial. have I KEAPSAKE So the

For it the what we readout, expect interim set data kind for that? could of

Yes.

So, as be and about on we so patients. the the is study focused endpoint XXX looking mentioned, are PFS – we as we'd

relatively looking be mature probably of or will half less of that, at patients we a So half subset data. little a than having for the

will – expected these data months, short around median dataset, population. patients The of Anderson PFS for was X.X that the the for MD because for PFS the PFS this

little will a to would patients. We PFS to that. be we for unfortunately expect be that it longer expect than these But relatively medium short,

relatively we a to XX be look So expect first at get that to PFS XX from to good able patients.

for And to just patients? is the very you color. maybe Thank that or any to KEAPX/NRFX much on that mutation criteria stratify subgroup there for part, other according the follow-up

Yes.

So, there factors will study. in be stratification the

or gene STKXX the on LKBX. called mostly also focusing are We

prognostic is this significance. So, to another prognostic mutation of terms highly KEAPX its in similar

And order important – so, that the arms. between have to an balanced we'd in like factor so to that's

by to status. be to versus stratified it'll the well MXbc as So MXa mutation STKXX, as

staging is between important their want will prognostic again, get which be – the criteria to essentially, well-balanced be So, these and arms. to so, variables prognostic we

Thanks I for that color. see.

Yes.

of comes Our the Phipps. from last question Matt line

getting me Thanks in right. All for there.

nice patient population. is Ipsen some going looking AACR, and inhibitor Takeda presentation showed pathway. at in the this KEAPX/NRFX at pathway, a data combo a to their pre-clinical at ASCO have looking mTOR trial they inhibitors the had with this And at So, mTOR

of this you of you additional on see Or getting chemo for would in but are considering some now? start-off, some combos Obviously, seriously data other guys setting? patients kind combo the you branching before these and interim trials KEYTRUDA wait into in focus

inhibitors. inhibitors working There a is process data. – are academic And with very interesting That's opening. that's that. and preclinical fact, the that combination a very nice the group So us. are been with has to – We've TORCX/X telaglenastat combining group planned, in the the with study actually TORCX/X in of there

with Mechanistically, rationale the we by Ipsen. think presented the So, that been strong. agree data interested very are that's we We in. generally is something have very

the sort about. of biology really I – work we've job we've a validating think talking they've that nice done been of the done that nice and

– AACR. presentation inhibitors. was certainly combination in support with this we we So, we are great a think are TORCX/X that at And and interested

to X then, data the for colorectal, neck Keith. disclosed last And that also we'd guys months? one. other Stage XX think others do but for, Simon ESMO I when at XXXX Stage am both still at an this the kind which but Thanks, of months indications any point, had update can't guessing, in And, and on more been stage or the some for in were head you you six say next you next the get reached X? year, moved all you showed

Yes.

Stage to to that. to liberty when at are other one can't But about X really head talk will – we'll X. And you not the move we cohorts. present now right and the be are we We guide Stage neck right, on able had from

cohorts As around we ourselves for of mature. timing. decision between you know, joint will and be a do a kind at these that like wait be to and We the Incyte to discussion right

have so, feel those the response the good like groups. for things And and rate and of PFS these the responses we in durability even a

ongoing. point, has are So, at you the right, and others neck are head no X reached Stage on this that. But and guidance

one Okay. question. And last then

out a and be frontline you cabo be to have patient hesitant that of positive able gain setting. obviously, will frontline maybe the envision So, see to CheckMate the to read containing relapsed in results on provide do Obviously, the But, CANTATA physician assumptions a trial. Cabometyx are traction just would the regimen XER, setting? we who for in cabo-nivo more a

was no a about in expecting fractionated of that frontline is have and mean, IO study including as positive the fairly be here. Obviously, they this positive. that to regimens we've talked I Yes. reason think that the are a in study were number therapies. past we competitive we've sense wouldn't amongst that to this There fully space –

would an I think I pretty it's two of of would entrenched Several at cabo agree, think containing which frontline to we are that a coming open question. least cabo the off But the regimen agree this which likely are would point. patients at of second-line. be in – come less on to I well in

we the said seen of think probably cabo. patients come will not majority large that majority frontline, that, again, - the of Having off having

still to in. being a cabo as for place approved And combination be second-line great be so, we seek cabo and for a to used

Having the said frontline we other look look have at or to the other potential that, at TKIs combinations, road. down even

So there a But, other second-line that with are very space pretty cabo could is we places telaglenastat. go place we for the good remains confident combination.

Yes. Thanks, Keith. Appreciate it.

Yes. Thanks, Matt.

There will are the line. Ms. no call on over more questions phone McNealey. I Jennifer to turn the

us. you, Thank you evening. and joining have Christie, thank great for all And a

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

You disconnect. now may