Calithera Biosciences (CALA) 8 Aug 192019 Q2 Earnings call transcript

Good day, ladies and gentlemen. Thank you for standing by, and welcome to Calithera Biosciences Second Quarter 2019 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference may be recorded. At this time, I would like to turn the conference call over to Jennifer McNealey.

begin. may You

Good XXXX Olivia. Welcome our to Thank call. afternoon, quarter conference second 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 a and website

provisions to the I statements the and today's prospects under constitute you forward-looking discussion safe future will Reform we begin, XXXX. remind our plans Before include the expectations, of purpose for harbor would like Litigation of Securities that statements about Private that Act

by may forward-looking various results SEC. the differ Form in in Actual materially including of from factors factors, as of the on those XX-Q indicated our result filed risk factors report discussed the these with a risk those statements important section quarterly

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

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

pathways and that our are for an targeting tumor call. Drugs thank the afternoon, us immune today company of joining for that metabolism on treatment other biotechnology integrated diseases. Thanks, Good Calithera, we Jennifer. molecule small second drugs. oncometabolism everyone, conference XXXX cancer building quarter you At are develops and cell novel and

drive towards We programs pipeline, team we candidates. impact new productive outcomes opportunities and positively continuously X a as development pipeline clinical programs in and are product molecules of commercialization. and creating patients our novel building new novel for multiple have targets our R&D candidates, consideration By therapeutic evaluates currently for to development

we the quarter, for our second proof-of-concept study. Phase achieved line of II randomized inhibitor, results telaglenastat, positive with clinical top the ENTRATA glutaminase In

positioned as quarter, are proof-of-concept is telaglenastat to and strategy study with in lead This believe advance of our is execute With doubles cell provides telaglenastat with forward. renal telaglenastat progression-free study the RCC, Combined everolimus we carcinoma. our our program. pretreated ENTRATA validation offering well cell compared median the our randomized clear in active cell the everolimus, the II for secondary that carcinoma, pipeline placebo with with we to patients treatment for demonstrating first as this completion on Phase heavily by and renal or positive survival

progressions It reduced the disease risk or death by XX%. of

in in is with now to consistent for clinic addition, activities previous profile the treating cancer. telaglenastat everolimus. a patient physicians with experience, with option clinical other safety to Based on selective cancers. our In glutaminase first treatment Telaglenastat randomized demonstrate proof-of-concept first the study, a activity potentially to this the and novel combination the of clinical treatment has provide telaglenastat inhibitor the well-tolerated and RCC potential is had compelling the believe the and patients for in we observed enter future,

glucose the Telaglenastat its focus growth everolimus the as an demonstrated blocks in TKI, glucose cells. or of tyrosine in cabozantinib, inhibitor for results metabolism inhibition Dual antitumor activity many kinase we of is about synergistic mTOR are the to the cell in the showing us telaglenastat invest renal that trial, weak a to of cancer today. glutamine inhibitor, treat excited telaglenastat in mechanism and the metabolism with such key transduction has inhibitors, of to RCC and metabolism has preclinical a That importance been of combined for our of metabolism because of a Signal glutamine, to inception. models. pathway since results are Tumor two cells. survival is used drugs many continuing classes Based company be ENTRATA and blocks mTOR RCC. in TKI or in on of this part We're of active that action, potential particular tumor common either carcinoma. as inhibitors,

are enrolling evaluate trial RCC approximately the called CANTATA combination safety cabozantinib. of cabozantinib. trial efficacy larger a patients and randomized CANTATA, to XXX telaglenastat to trial. That combined is pivotal with is telaglenastat in a double-blind, second placebo-controlled in designed designed be currently will trial potential with registration We a enroll and global

We on second line report by track are XXXX. in enroll CANTATA to to year-end the of results top and half

continue invest carcinoma. beyond We telaglenastat to renal cell also in

Pfizer development multiple broadened trials, as program or two investigator-sponsored our IST. trial clinical for with clinical telaglenastat have We to as new collaborations well

In CTEK of addition, investigation telaglenastat broad a NTI-sponsored part is clinical program.

be drug to needs. Our highly internal candidates differentiated novel drug produce in to the therapies of with team new potential unmet areas discovery continues

Our candidates X drug clinical both entering in new internally molecule discovered are novel development XXXX. small

one treatment the treatment of first cancer. CB-XXX, is the the I inhibitor arginase which an cystic an study. oral already CDXX for one inhibitor of And second small Phase for fibrosis, in CB-XXX, is molecule The is oral

trial, second to As forward look registrational our the forward evaluating Barcelona. milestones. in inhibitor from half programs renal ESMO arginase the move a of program, we Conference treatment with forward we of in telaglenastat completing patients important our carcinoma the at well year, INCBXXXXXX, as the number presentation data In development, in to as CANTATA our for of XXXX of look cell enrollment the

to with clinical our the update for And programs. will an Keith I over that, pass call on

Susan. you, Thank

We're the glutaminase more and product potentially clinical candidate. a inhibitor of update currently randomized cell trials and path on for telaglenastat on telaglenastat a program of our with RCC. The forging begin our two carcinoma. Let's renal clinical in includes most focused treatment commercial advanced detailed telaglenastat, for

the patients, in achievement noted its lead line us trial milestone As randomized because mentioned, proof-of-concept positive of as a line in The provides endpoint trial ENTRATA Susan top for survival, our announcement is first progression-free top results results in significant late-line for met first of our of compound, in and June. telaglenastat, everolimus primary II the telaglenastat. Phase it our combination recently with

to everolimus cell the trial, for results carcinoma a when medical the pretreated renal update doubled added medium advanced meeting and on future. primary heavily you plan progression-free in with met timing in versus telaglenastat In at to presentation its in can better We placebo. everolimus the submit endpoint survival patients with

a combination enrolling and global of trial third in with CANTATA, actively are We RCC line patients. in telaglenastat cabozantinib second also

being PD-LX stratified a -- therapy. randomized in will potential. and with be and endpoint. who the with patients overall in including primary by previously at agent will one-to-one X survival prior anti-angiogenic is plus to approximately telaglenastat or risk telaglenastat cabozantinib It to the prior received cabozantinib is X has X safety ipilimumab/nivolumab designed of of cell placebo-controlled XXX IMDC versus efficacy in least lines placebo plus registration placebo independent Patients prior RCC secondary is CANTATA the The combination. survival cabozantinib endpoint evaluate are by combination clear Patients trial therapy, as be a category patients key ratio in plus randomized have treatments anti-PD-X, a cabozantinib. prior progression-free either assessed or review, and or

Calithera's trial rate new Late TALZENNA, with pleased half also to also X the known announced Pfizer's the inhibitor, we known telaglenastat. inhibitor, combination are collaborations in remain and on year, last of top enrollment the in clinical evaluate report as the We as of with of glutaminase PARP CDKX/X each and second palbociclib, to IBRANCE, track talazoparib, results we inhibitor, XXXX. trial, CANTATA line

recently in that to plus also of a with with I/II PARP proliferation. cancer telaglenastat BRCA and both cell models. DNA damage and mutations and cycle a blocking of CDKX/X We synergizes with enhance patients the clinical in HRD-negative initiated tumors suggests synthesis, cell inhibitors HRD-positive potential in in talazoparib impair trial patients, trial and synergizes block cancer The DNA with combination Phase evaluate data proliferation Preclinical of will cancer Telaglenastat to gene. RCC TNBC. the by telaglenastat's talazoparib cell inhibitors enhancing sensitized regardless telaglenastat arrest

of plus colorectal opened palbociclib cancer, with of in the clinical cell and lung combination KRAS cancer, a mutated In telaglenastat CRC, KRAS-mutated patients July, I/II we NSCLC. non-small patients trial Phase with

into protocols that cohorts. are We dose escalation open now the patients are pleased and enrolling those each of

Next, the cells, secreted checkpoint by and in suppressor also known arginase as targeting activation immuno-oncology cell to arginase block immunosuppressive inhibitor is myeloid-derived MDSCs, investigational or XXXX, enzyme an metabolic tumors. IMCBXXXXXX, first-in-class T program.

co-development, collaboration. a program developed trials. Incyte being actively XXXX is The multiple is progressing co-commercialization enrolling and well XXXX with is in

The pembrolizumab. and combination evaluating first to would in XXXX as trial with is like highlight we a monotherapy

diseases. X is late XXXX tumor Primary The We to pathophysiology include Under fibrosis in has regimens; specific critical Incyte, fibrosis. inhibitor present been objective second an in in nononcology safety develop response endpoints arginase meeting fibrosis. and in Incyte, agreement and nononcology evaluating with is worldwide in arginase September. clinical solid each of FOLFOX, in cystic proposed including rights inhibitors chemotherapy a paclitaxel. at rate. rare other we presentation or treatment in development gemcitabine/cisplatin our ESMO of with cystic data several disease the for combination plan -- and indications, collaboration trial Arginase novel be cystic the oral our partner, to of to development retained the CB-XXX

plan of in lungs, depletes when first-in-human antimicrobial Phase normal trial. potent We CB-XXX initiated and we CB-XXX with oxide. this complete to FDA In lung neutrophil their trial, and inhibition the arginine we patients. year in Phase and have high to of restore been depletes arginase evaluating have neutrophils with CB-XXX an activity for Nitric shown hypothesized can CF which to NO, February, known U.S. CF profile turn levels, patients in the these IND a healthy arginase oral that and function levels High which patients. oxide, of and safety, administered improve we application arginase. that nitric in or NO lung I pharmacokinetic arginine, clinical announced is activity infiltrates filed secrete has volunteers. improve to is This function CF and tolerability I

bioavailable drug of an enzyme adenosine orally in inhibitor an oncometabolism pathway. is immunosuppressive candidate the next molecule CB-XXX, Our CDXX, small

ATP preclinical activity extracellular and models. clinical of initiate CB-XXX has We suppresses standard immune studies chemotherapy with combination XXXX. into by animal activity both in in a activation in CB-XXX, inhibitor single-agent CDXX, to and plan CDXX oral adenosine. with converting potent anti-PD-X

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

in June $XX points. were programs offering of today's which our following Thank included Cash press We ended believe and inflection at release. million. to our in investments the value of I to position this everyone. Calithera you, gross second results drive June, secondary meaningful XXXX afternoon, clinical million proceeds briefly raised cash financial in XXXX. XX, $XXX.X Keith, the Detailed well for were quarter on call. our we results review capitalized, enables quarter us our will good and

XXXX, million $XX.X for primarily in a trial, quarter year. period same was prior expenses $X.X including increase telaglenastat ended $XX.X for for million R&D compared due the $X.X million expenses $X of increase year. program, with an in three increase increase period CB-XXX were the The same the $X.X June the program, were million million XX, the million ended for compared our CANTATA with in XXXX the G&A XX, $X.X of million an months $X.X prior XXXX, the million and of June program. to

The increase ended services related I or from million of the the professional Net over will XXXX, was with $X.X for higher June back XX, Susan. costs. months to $XX.X million that, call turn per was And $X.XX now share. operations to X loss

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

[Operator SVB our from Leerink. And of the from coming question Chang first Instructions]. Jonathan line

the on Congrats all progress.

ESMO First the for how data you data of will how mature question, can terms much of in arginase help and ahead be? the program expectations the us at presentation

be Yes, to a study combination well variety as XXX just and data the study. of cohorts. studying so is XXX pembrolizumab And you XXXX across the presenting the will as monotherapy from remind

as monotherapy data, the cohorts. presenting monotherapy cohorts will be -- well some combination of as we the So

Just study as the to reminder, enroll. continues a

will on part data of on a this maturity based cohorts the in data. present subset so of And we the

Got it.

ENTRATA us terms historical you the of everolimus? patient for on can help And positive population update, we in contextualize the question, disclosed how thinking about Second should in data the the be study? benchmarks recent

Right.

this yes, very pro is pretreated prognosis a population. So heavily

prior that these were were X published. patients towards kinase were have They therapies. just weighted inhibitor tyrosine previously heavily so categories in intermediate relative of and And and to been these most -- diagnostic received data general, core pretreated had

more suggested Prior everolimus. second-line the, population the say, first for heavily I would for new was have pretreated. populations. set this line, in X.X something the of of this months patients And in So data again, was range the this data everolimus receiving would PFS in later the

when -- our surprise that result the approximately a demographics. investigators two the so PFS reviewed actually not of And so to was we months

going to the In prior population. and let PFS on fact, it's demographics this having blind likely know reviewed we they a actual short then, the us be data for that to

the Got we it. to when see And presentation can expect a ENTRATA of data?

policy. in So is a practice of to submit our then the and embargo -- meeting exceptions to to disclose line medical data with meeting

have in when year So next of months more of plan know. quarter either or the year. we to we more coming you But information, first this we disclose will let data,

it. post question. runway last Got on recent cash And Any offering? X just the guidance

at guidance. you updated cash million. And But time, ended know, of we haven't $XX as $XXX.X expect that We to $XX million we the million. at utilize year to

back January. was guidance million been The and that that in June. in didn't include we raised that $XX the So updated hasn't just

well each the our we CANTATA these of capitalized I to programs, to milestones However, say meet including in are trial. can X continue

Our next question Bansal from Mohit the of Citigroup. coming with line

study. on about my Congrats And related you're contrast And all CANTATA? to you remind which side study. progress ENTRATA arm the What from of in control how the ask following patient versus If CANTATA again then question we population, ENTRATA should I you can us the the the compare there? are from well. as just the X expecting may in enrolling

missed. question, the I So second think I

Its powering are CANTATA are powering versus study, how for how related of arm assuming What study? control treatment the arm? you the are you control And you to assuming there?

Okay. Great. Yes.

So yes.

they So significantly the between populations CANTATA less RCC the these pretreated X patients, cell study. but And are that's are -- above similar. studies clear RCC in patient

primarily CANTATA So I'm approved, currently really where is sorry, is setting. cabozantinib -- where we're the focused the second-line which on in

patients or X required these X therapies. are have prior received So to

They X second the frontline have is they -- third or in I/O TKIs. will line. they a ipilimumab/nivolumab combination had previously received, I there or see X prior So if received TKIs, could or have X received

and most -- least, patients at of prior in X pretreated I/O but have patients these terms TKIs. TKIs. these expect to to many prior of We less would prior -- X of heavily received So

METEOR to control study, in the of And the cabozantinib In was PFS terms range the months. arm, the METEOR is X.X population of this similar a in study. the

some off patients have subset Again, have straight better be patients coming historical data. might of will -- somewhat And than are ipi/nivo. There some expect do we differences. in those should of to

we hand, forth. categories of so other terms are the other prognostic of what in On also that and play there the distribution factors -- are

hard to we're longer, METEOR not in probably it's we're be substantially. maybe the seeing than But study, So longer what slightly predict. somewhat but expecting will

the action. one mechanism should be Did responses do setting the kind from Got ESMO, may more pronounced data, And if with more. I monotherapy it. agent? expect ask you Or of this will arginase we coming responses at the in combination think of

Yes.

this new that PD-X. active I/O been has feeling Our -- developed are an being as I/O this more most therapy, would to as therapies be agent likely be with in combination

development really so our that's our plan. And terms primary in focus of

So we'll on think proof-of-concept that's where that I But inhibition the for has that about of question. And and nice -- really were if say, we molecule would to focus. more responses, talk I it support able you But would to at arginase activity. be that are see I nice its think own would But the ESMO. I responses be

with And Blair. William coming of from question line the our Phipps Matt next

Since placeholder? data much little there they how a Jusy program. there, Is coming be is of the results the arginase towards kind obviously of the first, coming will in September, it's of believe, itself? I before in on conference more that are One actual the end a abstract?

think somewhat to months. the focuses see is and what the and will the talking that ESMO. on fluid be of of it's of the is And we abstract I so trial, focus a to and ongoing think for course, we'll update that indicative there we be the abstract's couple get an of it be will most as data about similar closer an presentation. depends I focus upon But

you on the overall to that. where presentation lined think data results? know ago. bring so lots full to know will do yet I But top the and the results, you weren't at you are guys of when months couple will they it out ENTRATA look trying figure So have depending still I survival guys matured

again, they're Yes it mature. -- we'll when data OS -- present we'll present the

whether impact that presented, will presentations it's presentation. be the of possible timing the will so certainly in OS data not And OS data may but or be that

populations, in Obviously, lastly, just the space palbociclib recent in this given thoughts then with results activity I get AMG XXX mutation. the now kind these on specific KRAS one may that's be KRAS-gene your And it. combo of of inhibitors. particularly only Got and to want some the

angle can that kind that's about thinking maybe you're but how So landscape, curious of guess. you take, an just I

Yes. of that site particularly Obviously, the the to -- unique a been are has aspect KRAS them data makes impressive, mutation. susceptible. a And is restricted is but they there specific binding it

And whether to or it's question. open think other be as so inhibition, mutations not an KRAS will I susceptible

it's frequently And population. we're target cancer, need. confident So the as one genes at unmet an that continue you in most to and in know, interested of we remains remain important still omni and the mutated KRAS

Do you combo some next studies think we from from initial year? the Pfizer X data see data

study So by cohorts. open-label the followed be going design the to is of dose escalation open-label expansion

it's the but is would think know the study. now this to end I data present, . it's So right can not year, have But might randomized early we that some that we possible blinded of by a obviously

So it's possible would able the be next of that year. end to by we do that

And I you you think back for trial to see Especially Or with last randomized additional year? the next of for Do Where wise ENTRATA telaglenastat, year, expansion the trials right the see data. plus two question. kind looking strategy results. combinations. Obviously, with additional want the combinations? broad results, CANTATA also now? indications happy this to this on ongoing results positive the true of positive novel do

Matt. That's a question, good

addition, involved that's an that, quite current care are interesting saying start retrospectively that and ASCO, looking Intrusive of in to therapies, data poorly continuing back taking at of synthesis, PD-X had highest trials nerve the X glutathione the on where other pathway population stress and lung continuing is presentation We have showing sensitive. the population in, glutaminase of us in that's to examine probably the managing interest oxidative possible to others cell look to trials, key at at and And this serves that's we chemotherapies. both pathway,

we're and in in trials considering and that the data, ways questions we possible -- aware are So address to of future.

Our line with Fargo. coming next Wells question the from Jim Birchenough of

for this on Nick afternoon. It's Jim

First trial did And that first do XXX. look expect start to the like? trial? be you would CF on question when What

starting -- it's and -- first just this of question I'll When hear, design was little fibrosis was hard The the to the it. confirm is trial? trial a cystic

Yes, trial when trial think And trial? would you what yes, I like? -- when be you'll mean, does that to the look that is able start

Right.

So mentioned, and as CFTR CF safety studies so all CF on And mutation therapy patients forth. currently their able running of status, we're healthy the enroll and PK evaluating backgrounds. studies we patients, their irrespective and in will include be volunteers mutation so we'll current Patient of modulators. irrespective across to patients,

an So include renal population biomarkers be evaluation dose sort of evaluation will broad, and safety of as endpoints both escalation as of that business like and well of . your we'll

that guess of year? can I is next first early you next something half year start you think or

Yes.

reasonable I a assumption. think, that's

And on XXX, Okay. that... inhibitors CDXX then obviously

Dropped off.

showing am queue. himself the from he removed I Okay. just

through. dialing Probably

minute can dial in. him one to give We more

[Operator Instructions].

next question Our is with line Chang SVB coming from Jonathan the of Leerink.

fill Just any your been of provide the void. enrollment you Can a how plans the on study consistent enrollment going? of is question with initially? in sort CANTATA Has quick to the color pace

We've Yes. across happy with very all been enrollment regions.

say track. are I on yes, So we would

no over turn Jennifer back I'm the like remarks. closing questions. to I time, showing for call would to And this at further McNealey

joining all today. thank Have great evening. us you for a And Thank you, Olivia.

This Ladies your program. today's for conference. the participation and gentlemen, thank in you concludes

day. have may disconnect. Everyone, a all great You