JNCE - Earnings call transcript Q2 2018

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Operator

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Second Quarter 2018 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded at the company's request. I will now turn the call over to your host, Komal Joshi, with Jounce Therapeutics. Please go ahead.

Komal Joshi

Operator. you, Thank welcome Financial and Jounce Second Therapeutics Good Conference to Call. XXXX Results Quarter morning, the This issued that we morning, the plan outlines we to a press discuss today. which release, topics Media available the www.jouncetx.com. is our release The Investors and website section in at of

presented will activities; today's CEO our CMO, who Beth followed who by guidance a at our financial with pipeline call Rich our focus meeting; XXXX will clinical recent data second results. will and annual on second Trehu, discuss lastly, our the Jounce's Speaking quarter progress CFO, Dr. discuss and review Murray, the ASCO be our along quarter on Drapkin, Kim President, operational updated and will preclinical cash our development Dr. with

for call We open your will the questions. then

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

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

future, we views any Rich. I may these our some the now that, call disclaim update forward-looking in to specifically While will over the elect to at even With we do statements obligation change. if so, to turn point

Richard Murray

everyone. morning, good and Komal, Thanks,

as of and drivers executing at XXXX, our for mission out in of the immunotherapies. develop laid class first we're I discover on four As start to key value part year the

preliminary First, efficacy our June. trial safety we and at ASCO in data ICONIC reported from

of pembrolizumab. that in announce way with in evaluating escalation dose cohorts, to in the pleased and combination under is with the JTX-XXXX enrollment safety combination we're Second, ipilimumab

a PD-X to I our we've candidate as announced, for the track studies. an that of previously first on proud continues initiation group that's file to goal inhibitor. Third, we continue team And advanced with well be and IND at focused to JTX-XXXX, with enabling Jounce. The of experienced we're on macrophage the collective execute ipilimumab IND built team cancer serving dose our fourth, patients. escalation the We've assembled the into pembrolizumab. of and cohorts talented highly

safety and interrogating remain escalation. the we'll the inform dose the continue ICONIC, tumor evaluate that immunotherapies. and after next to the ongoing, work is is the to firmly belief the important and characteristics We clinical, data biomarker of steps approach biomarker in committed While our first-in-class to development discovery

remarks, but to track Beth on PD-X year. provide her We I file it later an her, broader the JTX-XXXX Padmanee science before Sharma of I'd founders, pipeline. like Jim IND Dr. JTX-XXXX, remain from will data your Now, our were the JTX-XXXX activity by presented nivolumab, turning showed clinical safety encouraged and profile ASCO. potential with JTX-XXXX cancers. with combination We fundamental a also both nivolumab the data accompanied to at of with and by alone patients to more attention this to our and which back hand advanced for on over to context links in favorable the with monotherapy signal a combination pharmacodynamics turn pre-treated biomarker, Allison. heavily to in in in two a inhibitor,

for owned our tumor to will the immunotherapy achieve wholly continue cancer potential believe pipeline, an particularly in important combination of JTX-XXXX we see that be We [indiscernible] asset our necessary full to programs. therapy and as

prevalent believed in across certain the microenvironment. of previously macrophage additional immunosuppression indications we're macrophages in an As IND tumor-associated are add types within studies and enabling candidate. Immunosuppressive for layer announced, tumor our to first tumor are

the immunosuppressive and way. innate macrophages to We're this the is but the in to goal excited microenvironment about thus response deplete modify potential engaging not immune tumor the an system to state, Our convert to cancer. immunostimulatory

programs, we're target less stromal more our broaden targeting less immunotherapies in science it's the about promising. We types, inflamed we to and important addition also discovery current directed diverse cells. In and enthusiastic the to including macrophage believe tumor immunosuppressive Using are our cells, T-regulatory a to programs T-cell other platform, microenvironments, which pipeline. and build also cell translational continue

the I'd turn Beth. like to over to Now, call

Elizabeth Trehu

Thanks, everyone. Rich morning good and

inform clinical Jounce lives of on and is utilizing ultimately focused trials, impact tumor patients. and Rich interrogation to cancer mentioned, our the our of As microenvironment the refine

safety, binds per antigens patients cells. ICOS in anti-tumor kilogram negative registration. every preliminary II PD-X both way JTX-XXXX have failed tumor antibody which of cells, a The an Before and safety requires When data We who action. gastric, fastest the very evaluating levels study cell, the JTX-XXXX ASCO, failed and resting reported head X.X types milligrams entire were had expressing clinical the ASCO, administered trial JTX-XXXX data supports and These further ICOS. that were therapies have of features surface levels alone of non-small review monoclonal from development is reduction I/II emphasizing available and of safety; low turning is patient and results towards the believe from the of the inhibitor to data shifting JTX-XXXX weeks. data presented path well for these three with the to agonist and tolerated, respect ICOS as we lung alone With breast, tumor on efficacy with proliferation at I'd immune At and biological cohorts. was population. with CDX from T-cells approved, patients. we the selective patients selected cancer triple enrolled T-cells, see at and combination nivolumab, in more to doses all inhibitors trial targeting like to with that activity. are review potentially XXX mechanism to three to in the is required presented types an to the T-effector years, PD-X squamous nivolumab neck milligrams that and pleased I to tumor T-regulatory in for and they safe Phase clinical Phase of balance ICONIC heavily combination trial to in thus nivolumab, both ICONIC like be be treatment. the cells JTX-XXXX, even JTX-XXXX in identify activity; higher the JTX-XXXX, because now and ASCO of adaptive expressed. microenvironment we of are ICOS to to and signals we would at intratumoral In and cell pre-treated continues of the advanced activation it likely engagement to expressed

response. to now patients resist on inhibitor PRs breast reported and cancers. with biological at signals the Turning triple of clinical seen remain with the ongoing ASCO study in PD-X naive were PRs with The negative patients gastric activity, resist and

reductions PD-X have patients, lung other including occurred failures In cancers. stable addition, disease non-small in in tumor inhibitor cell and

blood clinical signals Importantly, activity of the appear ICOS to with biomarker. associated peripheral be

high it the believe ASCO, with than reduction patients this ICOS population this improved finding we previously and is because, have at with reported one, correlated is an and of data of peripheral which any whom additional two, patients primary presented their PRs XX% greater resist biomarker, blood. with to survival. in is it the T-cell JTX-XXXX, As all this with similar biomarker, We in lesions see did whom linked we in progressive CDX treated had directly for compelling emerge patients action patients disease. reported In target ipilimumab for of the was with not mechanism patients of in it emergence

this in biomarkers biomarkers. pharmacodynamics the also several study, to addition evaluating predictive potential In we are

data emerging We we which understand are believe strategies. the using our reverse translational the inform patient from future approach may to selection study,

of of signatures additional IHC as predictive biomarkers. biomarker potential Our as data supports continued continued evaluation assessment and the RNA well

moving features therapy. biomarker few strategy, into disclosed and the spend to our beyond ASCO observed patient rationale to discontinuation our earlier Turning of lines like at I'd on rate minutes a for

As of data in the or the XX%, rate approximately is patients an in majority with early enrolled which fourth ICONIC we heavily beyond. discontinuation similarly late-stage consistent populations. we of from patient were line presented agents other immunotherapy these ASCO, observed pretreated believe patients, In at

First, I for adverse a is rate toxicity, of low we the sure not very due clear rate to it want events. that discontinuation was to make as discontinuation had

that Second, were of the advanced early the the interpretation discontinuations nature due patient our to the population. supports data

that early stay development be to and discontinuation With Phase need believe rate JTX-XXXX with data our summary a to stay may our support inform of on earlier in that, preliminary II clinical will able the patients patients that my next we The safety, ICONIC from treatment of and to may remarks may biomarker a longer. Third, which the trial efficacy on I benefit. help confound into moving to up future see data lines assessment that therapy, longer JTX-XXXX. these of of JTX-XXXX wrap believe like steps. to of the portion efficacy, would We

pharmacodynamic of population study. we a biomarker response emergent identified we the understanding ICONIC JTX-XXXX move We next of cell have for on will build this into continue to as the of stage our potential and

in of and we pembrolizumab. with JTX-XXXX cohorts safety enrollment have ipilimumab in mentioned, Rich the initiated As escalation dose the combination in evaluating with combination

safety trial. updates to to look these we the the and and excited progress, We biomarker clinical the program. Based combinations, new inform are escalation simultaneously continuing As providing clinical rationale these in in are to next analyze on data for future. to the we dose of ICONIC both the cohorts biological forward steps progress cohorts

Now, over the call I'd to to Kim. like turn

Kimberlee Drapkin

Thanks, Beth, and good morning everyone.

This we of was cash release, for received reported by equivalents million compared investments as offset by totaled burn million decrease June million. and million. the gross $XXX.X as $XXX burn driven December to Earlier operations in to we cash ongoing projection refund cash, of morning's $XX As of impact. year, this approximately XXXX. spent XX, This excluded XXXX million guidance totaling on tax in XXXX, refunds cash tax press $XX any $XXX.X XX, provided

Jobs year refunds taxes tax guidance second Celgene approximately cash previously result the $XX quarter, We approximately million previously with the the cash resulted relating be During $XXX more end the to tax expect accounting and as paid provided the Tax of Act. elected upfront Cuts end to million in at in $XXX million the we and to investments. These on of gross a and to lower burn a method refunds payment. change received from of

for at We a XX continue the sufficient of position to least next our have months. fund operations financial cash operate and to strength from

P&L. the to Turning

collaboration compared Recall in was Our the reflects received that the currently the July same for the revenue, of to noncash, $XX.X payment revenue recognition collaboration XXXX. quarter for $XX.X upfront second million period Celgene XXXX. in million

was As activities our under decrease to collaboration due a adoption new in the first to and collaboration revenue in guidance quarter agreement. recognition the reminder, our of not due accounting revenue change the in a

reiterating million to our We million are of collaboration XXXX. $XX approximately in guidance revenue $XX

expenses. the net increased a or compensation $X.XX. basic costs of administrative same in net development quarter XXXX for and compared research million non-cash to result $XX.X XXXX. development second The and XXXX for period same share expense. million and share million loss The collaboration of $XX.X diluted the During employee G&A loss increase million Net in for by driven million the incurred is second and $X.X in revenue XXXX. an the loss expenses in and of for second the is period the operating same primarily primarily $X.XX in expenses to a quarter, a driven by per and were stock-based R&D we loss for increase as to costs quarter net General decrease the compared per million diluted a expenses compensation of in the for or increase in compared was was expenses basic of $X.X in increase JTX-XXXX. XXXX period $X.X This increased $X.X

focused the about think a key remainder right on will diversified to we right to portfolio as we and execute build and drivers bringing XXXX, the broad while the therapies As of focus patients. continue value momentum we our establishing on

Rich. that, Lastly, Celgene. global we a productive I back our over turn partner, maintain to strategic call to will collaboration continue with With the

Richard Murray

Thanks, Kim.

- the families, and developing to call trial. lives a take thank questions, extend high the We committed acknowledge trial need. ICONIC like the the unmet the discovering opening to the and to patients of patients and I'd all immunotherapies clinical of cancer moment of improve meaningfully their first-in-class to with lives teams, to centers participating Before remain the your and

the our patients of remains forefront day-to-day goal cancer work. Our of at helping

clinical and JTX-XXXX With ipilimumab pembrolizumab continue analyze to the of and the inform dose respectively, cohorts in escalation initiation to combination escalation. our ICONIC data of after steps we with the dose biomarker next

now the Now, half questions. IND development execution for With focused in the call like finally, XXXX, pipeline, open remain we'd second your our on that, JTX-XXXX. of to including we of and advancing for plan, JTX-XXXX Operator? the the

Operator

[Operator Instructions].

with James. comes Seedhouse question Raymond first Our Steven from

Steven Seedhouse

patients. of enroll if if the the dose II more to curious, from obviously less sense one to Phase or enroll we've being need do escalation have it's the will earlier ability the if just of able happening highlighted stage to the you a portion likely refractory been we Keytruda cohort you or wait You advantages cohort that's know patients? until to I'm

Elizabeth Trehu

escalation, Beth. and Yes, dose more select In we pretreated thanks. This patients. patients is allow heavily to tend not

until So it really Phase that II cohorts we won't we'll on be be embark looking for like really more efficacy.

Steven Seedhouse

noticed if last had you you to Keytruda their Are wanted on you for biomarker wondering ICONIC. you would just stage on question. through you're are how I obviously, that to frequently be just dosing just ICOS JTX-XXXX with fairly in any presented progression, ICONIC quick, have allowing - comment that to highlight the patients those based they've was there changed the between to its Or and rates update. antibody looking are at all at one response if antibody we'll cohorts? just and re-highlighted Just ASCO example? cohort they we rhesus looks you the initial or highlighted and R&D you respect GSK the the and I new enrolled discontinuation in similar? to earlier for in profile in I curious, relative how of assessing anything judge obviously, And quick the differences was

Elizabeth Trehu

in Okay, try order. those answer me to let

patients study trial. and we proceed so the as the on the some from So we to from of learning of have learn earlier we in features continue the

some along. adjustments as have made we've criteria We to eligibility the gone

at to allow resist as we the progression. I through that think modified well. we, confirmed patients to the had stay we patients do actually, of request until Initially, asked other the thing and progression they you about, on continue actually investigators allowed

that allow the and a investigator from the So stay patient change. yes, we they're do patients on now, that's drug. But as recent believe to the as long benefiting very

drop rhesus Rich the most that. the your off to after rest progression of for I'll So trial over it questions. maybe turn required And to modified to of we're patients, and answer we've confirmed

Richard Murray

This is Rich.

that antibodies that's and certainly just binding ICOS cross and data. to noticed reference believe look do we understanding the we GSK, there's differ reactivities in that target, the the For of sites - seeing may In of species difference know the we we forward the to kind the to that on two. antibodies, some target, a based between

then developed. Additionally, the JTX-XXXX along think is believe is not. step an IGG-X, which fits the emerge. preclinical ICOS we pharmacology seeing GSK package We And the that and in another believe to this look mechanism I data We path. mean we we lastly, that forward is this

Operator

comes question Cory next from Kasimov JPMorgan. of Our

Shawn Fu

This is Cory. Shawn for on

bit about in is forward your Though this can Just asset? one still bring it's little early path you established, are types? onto Is take are wondering maybe quick going indications of you forward that for or combinations to me. something a in still plan internal following the talk potentially here, more sort forward already goal niche guys be from that's to a potential regulatory or there PD-X just well question to this potentially it do but the novel, tumor -

Elizabeth Trehu

Shawn. Thanks,

programs, tumor So the stage it stated, we developing are current be not earlier to able approved. which going into are programs, particularly likely JTX-XXXX is in anticipate inhibitors our which cold primary for combine types as within be approved, tumor goal to not to PD-X the we

and way our are of to we aware develop We we thoughtful be of try the programs. landscape. about the creative However, competitive all

for the our always all best of programs. we're about So opportunities thinking

Operator

Peaker next Boris question of comes Cowen. Our from

Boris Peaker

JTX-XXXX. the own of focus curious, combos existing your objective on already I'm your when is developing just maybe what First, I'd anti-PD-X looking like at you're to with [indiscernible]?

Elizabeth Trehu

Sure.

themselves become JTX-XXXX, to in to move to add care with standard it of a example, these is tumors patients, be rapidly as the frontline, as them. say sense our you way in for we combination the in experienced standard lines inhibitor. said therapy. able moving you're and a of PD-X JTX-XXXX such where before, don't our PD-X with by that lines of on to for we're allows there think PD-X going use PD-X which you combine up it move That's more other into don't earlier where a as It inhibitors particularly that couldn't So inhibitor I've have we those not PD-X very a a makes for of into goal to the T-cells care. inhibitors different have typical really lot a to to inhibitors programs, tumors PD-X if the are there, into to develop earlier do drugs, cold But tumors, primary because the path earlier in is drug. therapy feel That's

as is with and cold do tumors. we that strategy immune still you those our you a pressing inflamed to infiltrates if so will. that Because tumor And on be can microenvironment, bring brakes, want, try the the the need much programs more off gas you still inhibitor. you into foot your need take believe you you but tumor to Once have as checkpoint you may

that value And going believe so where that already of in greatest because is there be approved space. we be JTX-XXXX inhibitors PD-X to won't that's

Boris Peaker

Okay.

for And XXXX drugs? to combo so your or - with only going have be is plan to plans run ICOS then, is you actually monotherapy the in to it

Elizabeth Trehu

safety any So to demonstrate start feel acting and to is importantly, it just has PD-X that monotherapy it's efficacy have a monotherapy and potential we partners with similar like inhibitor important to escalation and dose a demonstrate the we'll profile. to also most assure,

our then, it and most pipeline monotherapy with programs. with likely we So be again, will earlier starting combining

Boris Peaker

on Would when timeline clinical ASCO an else earliest see or of kind we should ICONIC do curious, the last the XXXX additional or what question a just my update. trial. potential meeting? be see should medical as you I'm expect And theoretical

Elizabeth Trehu

the So we'll update as progresses. provide more program

helping this the and morning, current investigators we all The escalation biomarker those to are dose for to dose from really stages clinical data the the that. pleased engaged middle. involved cohorts by we're how while escalation do remaining we enrolling, cohorts, are program. quickly the in We've the in the initiated but able dose about As both very mentioned think analyze and continuing us remain of were We're study we cohorts. also in in And study. the escalation next

that when we forward. steps taking all our about We're inform serious we talk going translational from We're So data will learning the study really the as next go. of reverse approach. and the

And will at provide so later stages we the information study of a on next date. the

Operator

Jim of Our from Fargo. Birchenough next comes Wells question

James Birchenough

A couple.

CDX you the cells, time before ICONIC case when it CDX that the about would of think response? at we of who of the First, seen ICOS have was emergence positive course patients discontinued which an XX% positive point the ICOS in

Elizabeth Trehu

Jim. a astute Hi, very That's question.

evaluation was datasets that So in high of our incredible. pretty don't have and it said think those I on CDX we've we T-cells, ICOS everyone actually, complete

as as that study translational Our of assay scientists approach. ongoing, developed reverse part the our was

on we doesn't But suggests And data the cell don't have everyone. baseline until so later. samples type that that we appear really have

X. our of responder For that did occur until Cycle cell monotherapy population emergence in example, not the that

and may of in. too have for advanced patients activity hypothesis So for that is rationale JTX-XXXX to a moving yes, lot pretreated soon kick patients part come of to allow of off less very into sick earlier these the heavily therapy our and of lines

to may to effect. about to we're keep people treatment it take it on we ways think longer because able for so be longer take thinking And

stable it to disease but they progressed. they when patients In see we had in had some then is addition, started emerge, we lost whom who

would But early question ability the and think continuing the the patients, the yes, answer emergence late really these the do have JTX-XXXX nature interrogate rate, short we we're advanced So your is the discontinuation support of that. to reflects that population. that of which assess may to cell cell to efficacy population of the confounded

Richard Murray

to that, Jim. Maybe I'll add

look really look predictive context holistic the at drug population we more want the we activity biomarkers. as JTX-XXXX kind tool of other really to broadly that this important working. And builds an of think of package really important is an component, potential the the I of at scientific in emergence of understanding cell that as how

James Birchenough

of one that i.e. do is or broader earlier then to that greater is, do second I or approach for response, combining Or question response? cell the ICOS earlier. the you ipilimumab earlier response, have part there the you move And cytokine? think approach, can combination an guess anything with broaden the with potential generate other think CDX you is certain will could

Elizabeth Trehu

Again, great questions, Jim.

is getting population we could the and combination rationale strong. that So yes, a to that And the that with for very allowing biology earlier. be feel to strategy cell emerge respect for ipilimumab, - for

yes, we that to disclose have we're other think not biology be for sooner, the very on absolutely, activity cell Because appears try the well, anything long keep that emerge. important it of do emerge to enough we we for things as yet. to to help We do thinking can the population that about or drug. think ready them But and people to

James Birchenough

one just question. last Maybe

agonist ICONIC targeted Just the are data drug the that road? to development, an you a and the the inform capturing of macrophage might that ICONIC tumor-associated make program's combinations of program, you absence ICOS whether for are TAM get a macrophages i.e. or with presence down in in on sense sense looking might study,

Richard Murray

these pipeline, have to of be terms we important. type In we cell immune signatures the that per Jim, developing believe created

we future And we're outcomes collect as that and the all we evaluation. part that patient that's with of as so associated learn it, that from certainly and analysis capturing has data, ongoing

Operator

Instructions]. [Operator

comes next of Mike Baird. question Our from Ulz

Michael Ulz

on the escalation escalation nivo? with Just wondering in remind additional that's you're if you pembro, from different and ipi there can you're for testing to the prior dosage your testing us with that dose JTX-XXXX cohorts just with then and combo if combo comment in respect dose

Elizabeth Trehu

of in pembro, had trough that we what because inhibitor nivo somewhat the we sure different week II that than Thanks. we wanted escalation that toxicity were arrived we Yes, this well which we lower Phase when QX levels why tolerated. so we dose with combination evidence we're we which doing pembro, nivo with that recommended in a be a terms is with it's with optimal. to nivo, at than saw with was PD-X I with think extremely achieving combined a have so We see the really were dose didn't combination and

related we dose had II So JTX-XXXX the we before higher just to bit felt started a little moving with dropped because into certainly ipi the going rate more of further immune been then AEs, of data it not a nivolumab. some little a there, where prudent to has the bit challenge, But safety just to dose. And with drop beginning dose Phase up. little get back we're ipi, the we down going escalation before

Michael Ulz

then the with sense enabling the clinic. could of to you Should more get respect a when just IND we And be macrophage maybe studies, your to thinking trying in get program, just XXXX?

Richard Murray

along that Mike, proceeding candidates as and with well. moving program but that we earlier we'll update forward as we're get closer,

but stated as haven't yet we a we date closer. will we So get

Operator

Ladies for gentlemen, today's session That thank you the does conference. conclude concludes answer our question and program. in today. participating This and for

a day. may all Everyone have disconnect. You great

Jounce Therapeutics (JNCE) 9 Aug 182018 Q2 Earnings call transcript