JNCE - Earnings call transcript Q4 2019

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Operator

Good morning, ladies and gentlemen, and welcome to the Jounce Therapeutics Fourth Quarter and Full year 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time.

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. ahead. go Please

Komal Joshi

outlines Good the fourth operator. conference welcome the our release www.jouncetx.com. release, to This to at we Thank today. website & discuss and morning Media full Therapeutics The which press a quarter we available results topics year Jounce that morning, plan in you, is issued and the Investors XXXX call. of financial section

and progress will and CEO our guidance. milestones Speaking clinical on update CFO, discuss President, will our our XXXX Rich by our Murray, will on Kim lastly pipeline Beth will review followed today's XXXX, full and who Dr. Trehu, key results Dr. for be our CMO, XXXX provide year And Drapkin call our activities. who an financial

your call then the We will open questions. for

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

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

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

the call With over that, to turn I will now Rich.

Rich Murray

good Thanks, morning, everyone. Komal, and

program to illustrated pipeline our several set which from therapies. Jounce are has IO therapies Vopratelimab to like benefiting analyzing our key our meaningful I'd lead clinical milestones new client, early patient well driven the translational will we the who driving made growing That X forth impact platform, XXXX best stems for XXXX. believe necessary in is trials advancements as a progress Phase we by apps. patients represents on be The progress from what science meaningful make reflect we IO inform latter to As science from or that today's to as new further towards our IO samples to development note not Vopra,

over Vopra made XXXX. course of we For significant progress the

First, the development introduction responding paths. on important biomarker analysis, vocal between identified extensive of results reverse trials. Based our and the of enabling two non-responding we the and patients, SELECT differences EMERGE translational

are ICOS linked AACR survival we Next, treatment the the progression emergent ICONIC with PD-X at to responses, improved exciting data HI showed not associated survival, overall T-cells. where CD-X These from directly free inhibitors. pharmacodynamic and cells biomarker, seen Vopra a

patients test upcoming stimulatory in of benefit. the predictive used which Next, we've the CDX activity likely work based select ICOS the will optimize done the SELECT of with to feature presence important how inhibitory schedule, Vopra and of and be for And HI an potentially of allow of more may rather believe experience immunotherapies. us identification patient to to dosing than trial, generate clinical biomarker to be cells T selection we which Vopra in

with very unmet have why cell last could advances checkpoint lung to reflect on to the Vopra a like in before needs treatment made Beth and do. XXXX, both everything of been opportunity more changing this exciting need and details will As But take unmet the major decade's through at in the the on inhibitors. to cancer. we turning in faced call be forefront approved cancer non-small impact, starting I'd SELECT look oncology, to many continues we moment. a significant you patients by game her, The take to by EMERGE over

treatment have and inhibitors further progressed options. of who growing a need patients frontline new therapy, PD-X number therapies into further expand on As these

initial relapse unmet XX% we Standard non-small U.S. as the lung which this is rate a of non-driver patients PD-LX for toxicities patients example, growing cancer their of has Frontline estimate care inhibitor of And not For PD-X part of or the approximately a low receive need. either therapy. cell in creating majority patient associated mutation. chemotherapy. population respond, area of the a or new response with and challenging docetaxel, those do

for U.S. in substantial, provide Vopra this better of vision with particular just opportunity patients that setting. is more Part in the this the than is patients market each to year treatment And setting. XX,XXX options in

We population benefit independent research be orchestrating a meaningful required novel continue patients immunology the will their the CD-X to opportunity Vopra. in progress biology that PD-X to decades, approaches are that who response focused growing of immune the of role in importance the Fundamental believe over and more emphasized derive to potential central of for the PD-X on speaks T-cells inhibitors. overall inhibitor and complete CD-X

already of inhibitor have Our along who improved Vopra in on retreatment inhibitor majority patient support which In the combo a populations, a inhibitor strategy most PD-X is naive PD-X other patients highly from this of outcomes again, of studies agent. may another regimen. PD-X with free the biomarker population, differentiated use immunotherapy of chemo a progressed employ with in the predictive

-X and select PD have for at plus benefit. Vopra TIS Vopra we Vopra As Vopra a JTX-XXXX. upcoming of uses of clinical SELECT our HI baseline the T greater generating believe the that's to likelihood potentially chance treatment presented, recently higher trial inhibitor cells presence TIS in ICOS We patients CDX patients a of positive biomarker with

to clinical our our translational progress our stage we Beyond programs make pipeline platform. using advancing continue earlier size

benefit track T monoclonal filing. an to cells. our area enabling and JTX-XXXX aimed a XXXX to for CDH our that of more bring next patients. types Notably, continue beyond come we cell cell is from an platform tumor traditional the therapies to of strategy IO on regulatory our is advanced developing to engineered first which candidate We T is while half cells sparing opportunity discovery immune at sites currently other to development IND resident of activities JTX-XXXX believe antibody standard deplete IND

We additional the of in supporting to data present tried the meeting April. at AACR JTX-XXXX scientific development upcoming

out with of broader our Vopra, candidate was full with have we've the JTX-XXXX JTX-XXXX, now On the to to discovery external and pipeline. unencumbered the renegotiation a macrophage corporate we that licensing development of rights global Celgene Celgene part entire and front, validation our demonstrated JTX-XXXX

to in second on On XXXX, Vopra the and heels in of half execution are pipeline preliminary in strong related mid to reiterate, a year for we Continue XXXX on key biomarker meeting. we data Initiate important enabling XXXX development data first and new corporate the from data from XXXX, SELECT EMERGE trial an efficacy of an of clinical milestones AACR poised the of using plan for report activities to new JTX-XXXXat of advancing trial the the filing Vopra XXXX. TIS on JTX-XXXX multiple our XXXX IND with continue pipeline. work the targets the for discovery half and in in present expected

With Beth more call over detail. now that, and our science I'll turn discuss to in the further to clinical pipeline

Beth Trehu

good Rich morning, Thanks, and everyone.

program on significant introduced mentioned, important milestones and two in Vopra to year our paths different Rich is based our our for learnings progress Beginning data clinical Jounce, of an key new XXXX. and As continue with XXXX on have translational make key analyses. we development reverse building clinical

EMERGE is using our three trial Vopra. the induction from and strategy SELECT selection is biomarker in on second The Iconic. first predictive major TIS are our the and SELECT Both trial based EMERGE patient our strategy approach trials learnings the in

X and benefit treatment survival, free are progression with First, we PD the including in effector shown HI we associated emergence overall nivolumab CD-X in does believe rate, response cells alone clinical treated emergent of therefore that survival. patients identify of are that specific therapy ICOS they inhibitor Vopra and with these peripheral not Vopra occur We've T cells. that or cells with with blood combination

also HI throughout CD-X some and expand that over demonstrated have two ICOS We cells T responses years. durable persist

Vopra, baseline is identified we regimen an CDX we predictive biopsies, emergence is identified for we tumor more of hi believe And prediction TIS in a of ICONIC. RNA optimal ICOS and Vopra. which optimized what clinical Second, third, for we benefits T-cells which in signature dosing call

with of upon analyses reverse trial. our our founders, fundamental coupled ICONIC Vopra All built our trials of translational are science the the from

Another hi been primed has the Vopra key of T-cells. activity requires learning presence that ICOS CDX

our has in All two of paths. development work Vopra this culminated

multicenter or using trial is T-cells lung for hi open-label IPI the cell ICOS administration T-cells is prior path experienced IPIlimumab cancer. X induced trial non-small First, CDX a of which induction hi study administration, ICOS Vopra trial, induce path PD-X patients prior with by the to to Vopra. agent The are another CDX induction is Phase underway which in The to the in EMERGE

of PD-X need this unmet settings. moved Rich have high an As into mentioned, inhibitors is frontline area as

agonist. SELECT for trials, we As implementing are we dosing EMERGE appropriate for more have an believe a previously, the we is which and strategy new detailed combination

respectively. of IPI of that the Vopra EMERGE understanding and ICOS using and T-cells hi hi we CDX our optimizes strategy Given in the of sequencing We believe kinetics expansion T-cells combination biology. both unique induction by are that ICOS co-stimulatory CDX dosing and and

Jounce therapy. has believe differentiated and a to We approach immuno-oncology compelling combination

EMERGE for We second to and biomarker clinical preliminary to XXXX. the including of data the half up patients lung from cell trial, efficacy report expect non-small to outcomes relationships XX cancer in

and CDX predictive Vopra on improved to in T-cell Vopra, with associated patients have the benefit. was ICOS hi is likelihood as gene as as in for hi positive free CDX in TIS SELECT we six trial. PD-X nine that developed style which Vopra SELECT progression of ICONIC, biomarker the and signature is Vopra resulting well threshold presence the an the inhibitors. originally baseline the T-cells rate, predicts Based of and potentially biomarker predictive path, survival tumors survival overall XX-gene if of TIS positive a TIS patients from The tumor a greater signature study is determine in clinical higher Vopra patients. samples investigating response identified ICOS evaluation months TIS The will emergence, generating designed

X is Vopra. in associated of genes be Vopra JTX-XXXX integral contribute elements JTX-XXXX includes T-cell comprehensive response. SELECT with also randomized more trial alone. comparing immune TIS the ex-U.S. inhibitor In to PD-X Phase cell TIS non-small may patients will However, to that our selected a biology SELECT lung plus upcoming using trial, CD-X cancer

approximately XX enroll be to immunotherapy cancer non-small expect patients second who the will lung naïve line cell using Vopra tis biomarker. We selected

for second line that non-small patients estimate of will threshold trial. TIS be lung Vopra approximately the We cancer eligible cell above and potentially the XX%

mid-XXXX in XXXX. interim to and initiate trial We SELECT clinical the in data report expect

rate partial and profile XXXX efficacy note November, one JTX and to an flexibility provides overall acceptable antitumor response X cost X with options. therapeutic observed treat in safety meeting city complete safety Phase a was data inhibitor with we including own no activity Turning and XXXX preliminary responses. with at our All savings. Using an difficult Vopra with resist PD to two population combination confirmed responses in and the XX.X% in response of of presented

I'm accomplishments the proud XXXX and to XXXX on clinical progress biomarker and continued look team in trial of forward in on of clinical data. our execution and readouts

Now, Kim? to our I of discussion would financial a over Kim like the to turn yearend for results. call

Kim Drapkin

Thanks morning Good Beth. everyone.

we was July, XXXX. XXXX The the this cash cash, XXX.X As to pursuant press reported year our we million JTX million $XX in the XXXX with during XXX.X compared for operating due release, agreement ended license and million to costs totalling by investments XXXX license incurred morning's fee with equivalents in decrease Celgene. to offset primarily received

non-cash year XXX XX.X XXXX P&L, XX.X the the XX Turning year cash with XXX.X was compared million under of recognition JTX of million full payment of to over The and includes collaboration to license in XXXX. for we Celgene upfront our revenue XXXX. Celgene million million agreement year related million license received to the that and received XXXX revenue for increase

of research XXXX X.X During for costs. costs for for XXXX XX.X we the million expenses XX.X million compensation The to was in decrease partially incurred year and were of XX.X expenses was development manufacturing expenses and million XXXX. XX.X and decrease due General costs. enabling million by IND increased X.X million million X for to in administrative full XXXX The consumable and XXXX. lab a decrease R&D to offset compared decreased compared employee million

or for income primarily or a in G&A increased of $X.XX share expenses of license XX.X million the basic our collaboration net compared $X.XX. agreements to a loss XXXX by of was XXXX a as net $X.XX compensation costs. employee with under diluted diluted increase net million per increase driven result is million share of loss of in The per This basic and revenue share and XXX.X per was recognized net income Celgene. income of Net the XX.X and

the in XXXX guidance reiterate January. financial We we provided

for million continue to year to capital cash million. expect operating burn expenses We growth, on and be the expenditures XX full to approximately XXXX XX

JTX our revenue collaboration and license payments license our XXXX royalty future providing potential milestone longer guidance no are as and agreement We under Celgene, with based.

expect investments of equivalents of funding the cash, existing be we cash the expenditure our and of to requirements and our expenses Given XXXX. enable capital to operating through sufficient end strength sheet, our the balance

have Additionally, our executing strategic our to pipeline, officially plans we against innovative continue drive goals. the and flexibility immunotherapy to while

With hand call final thoughts. I'll for that, the to Rich

Rich Murray

Kim. Thanks,

clinic from the longer data continue options new call initial so scientific open the the we the a future for today the we where trials checkpoints from bring durable conversation Before the updating thought benefit for was to the envision can questions, reflect like we that with the help. need patients on than I'd lab made to But none will who we're not trying the patients that the believe to challenges closer patients with IO have I of patients back and topic broader to of PD-X concept. that less ago. therefore moving and have be broader gleaned success a created The advancements therapies precision to look our has decade those as you arisen benefits possible in treat inhibitors future. that and opportunities, do for a and to new progressed to in to forward that medicine

open the questions. And with that, to we now for like call your Operator?

Operator

Your of Cowen. line question Instructions] Boris from first from Peaker the [Operator comes

is open. line Your

Boris Peaker

and middle one cells make the is out number kind does And IPI broadly, selecting the IPI hi in to So EMERGE a trial. on of treatment question it ICOS don't Are an what show induction? the of in trial add booster patients dosing EMERGE sense more you maybe little the that from CD

Beth Trehu

Sure.

start question. second I'll So, the with

is to dosing the six with So given up -- Vopra. IPI every for is doses weeks four alternating

and Vopra. on weeks the than get get three weeks dose IPI Vopra. another And they then you IPI So patients one, later, later, day of three get

they after to So which we do up doses alternating for Vopra received IPI X sequence that alone. of

interesting of terms in question. CDX cells, hi So ICOS the a it's really

are we cells those closely. tracking very So

they what selection. doing IPI But of think watching after and we're are then not that future. carefully. we're again. then So do something it's very about And certainly Vopra kind to and in it's IPI the Right now before we after any following

this any in study. we're although using also, We not selection

potential We back predictive have baseline to -- we testing are able look samples of in a go biomarkers be we'll and number that tumor at.

treat of with Vopra induce IPI, those then time, expect with the the ICOS long proliferation CDX hi activation So, with we strategy term cause sorry, right to cells now and is to with our cells which over to clinical ICONIC Vopra which associated benefits. sustained in study was

Boris Peaker

on the question FDA? have last TIS would test Vopra What the My to make looks test, to is do you. approvable biomarker like a biomarker. very useful Got trial the SELECT if it you the by successful

Beth Trehu

already a it's so validated Sure, test.

a mapped diagnostic of that us be it's the partnership vendor there's to running already what clinical diagnostic out through So our one with look nano-string the like. we've just trial. path And companion the on actually work We and series in go there's a create that -- steps with to companion platforms. develop would you you would know, and would

Boris Peaker

be all in it know. the regulatory limiting So strategy to I that's terms of wouldn't do

Beth Trehu

all. No, not at

Operator

next from question comes line Fargo. Birchenough Jim Your Wells the of from

Your line is open. now

Jim Birchenough

The up. of then And is ICOS induction hi to got a induction protocol a you modified that is CDX of of and guys. reliable of for any cells rate so cells with insights EMERGE the details the induction? Thanks and, success there study, any the you're early the tolerability and X How and predicted I've dosing follow Hi on ICOS early the all there of couple, IPI of on IPI. related questions. that, taking have indication pursuing maybe CD A just hi it? is

Beth Trehu

Okay, sure.

I tell can that's report you do analysis the And now is right later enrollment to track on planning all we're to support is, really So when interim data. that year. we'll this

So information from ongoing we data any typically on don't provide the trial.

half data the in As going well question. to of have enrolments and I year we're on then the your second track said, other and

Jim Birchenough

induction status. …on for CD-X hi ICOS IPI

Beth Trehu

Sure.

induced little sometimes. cells cells, We've So, then the ICOS all the heard drops off on you gets get say it interpret very that, quickly. all induced. hard it's a people but to know,

a just a discern answer the trial ICOS what that are studies we our that's the bit induction it's hard because of finding. will from which done, been literature prospective it's IPI manner. from course more to in So little a of be. would exactly that retrospective measuring rate But Most the of expected in of been

prospectively with to knowledge, will IPI. at And on. added study, ours think I that's how So kinetics first the my then be of the induction Vopra ICOS looking after

Rich Murray

small small of of fairly of ready will and patients. from And able that. But we a the be PDX north publish We're patients The decent where some answer. studies, is theme our naïve we be tend always these Jim sustainability looking that tends numbers we're number in kind cells. will but to And to of the studies. done but experience are in all that they collection is be to to that's really kind of common maintenance PDX of think uniquely with a of XX%, and course think important extremely what claim, to trial almost and

Jim Birchenough

would learned question And the then final on that one there the evaluated one that make this other you value. what you, have you study were evaluated, were just SELECT predictive that if there just and other or one decent from and was really a you signatures signatures RNA Iconic, the sense only prospectively wondering just RNA and, thought

Beth Trehu

Sure.

the really, benefit. it we really looks at what tracked we then one assessed, a ICOS thought a one long also the we with the determined most if clinical was predictive this hi came pre important number we out actually, CDX list we had signatures So to T-cells. But of was and that that a, as that see and for genes of looked

it based treated then predicted like when one genes clearly And clearly and it was it first on predicted benefit. at for for to isolated genes, the we so, clinical since yes, But a it T-cells. appeared best. clinical applied to also looked ability number we then threshold And the also to of to And for predicted the ICOS T-cell CDX then we that this took emergence, data, patients hi with were then But prospectively. predictive selected a predict signatures many looked that. we different and clinical biomarker benefits. it value gene was that its apply of inhibitor, PD-X and hi these And this CDX ICOS see the be

Jim Birchenough

Great, thanks for taking questions.

Beth Trehu

welcome. You're

Operator

Your next from of from Baird. the comes line Ulz Mike question

Your line is open.

Mike Ulz

Hey, guys. Thanks taking for question. the

Just in terms sense second the another a provide? to in types expect and of update, Can half one on biomarker year. just the you of data this what you of us plan EMERGE interim give of

Beth Trehu

so CDX the engagement, Definitely are two those hi other T-cells ones. Sure. we've before, schedule done since we're than ICOS the new a target dosing primary what doing

We looking to also other we baseline aspects some at as biomarkers do I plan biology. some of said some and

Mike Ulz

of Got of sort can us numbers, mentioned time. a potentially patients, to the maybe follow of you but up give you've average sense it. point in terms just patient Maybe at XX in that up

sense Just how meaningful. trying get to the of

Beth Trehu

Absolutely. Yeah.

treatment timed scans. be So after treatment CT interim had least two post subject the has done or we've every at analysis on to

of all of before So we'll data XX have we report least any those data. patients at on weeks

Mike Ulz

Okay, you. great. Thank

Beth Trehu

You're welcome.

Operator

for of question H.C. Your Chattopadhyay Wainwright. the line comes from Debjit next

Your open. is line

Aaron Welch

Debjit. Aaron is for on this Hi,

trials how lung previously plan covid-XX non-small challenges enrollment are some you have have disruptions. go that to study And the cell do I So in many an like likely cancer SELECT tackling been with SELECT how given for you patients the given expect anti-PD-X. on about the to of this questions treated enrollment

Beth Trehu

there inhibitors which to we're actually this study very many access a are are limited so country. Sure, in there's PD-X that countries in the because approved doing ex-U.S.,

be there to are are where a enroll to anxious So in able get to places to patients access clinical PD-X inhibitor. trial a

that happy So that with we're opportunity. really we're them providing

for posed will by Regarding selective enrollment, be biggest having the biomarker. the a a requirement challenges challenges of that

for second Vopra [Ret] However, if Elk or cell to estimate with of some XX% three you're about will with investigators, TIS their be One of trial. the non-small to select conversations patients. biomarkers the cancer a where you talking XX% line in of comfortable And our think that likely they're very positive lung selective in population, X% like five about we screening. about patients is is

So a place we in tackle have strategies of different to number this.

and a in a to in XX us we to to we'll data enable preliminary for patients know, strategy patients those have You and data sites have enough way enroll have screen XXXX.

Rich Murray

be not to in IO clear, Sorry ex patients is to interrupt U.S. Aaron, experience study naïve PDX just patients the

Aaron Welch

And out to of just coming real patients evaluations Vopra could see expect the TIS any we quick, EMERGE of study?

Beth Trehu

at as right looking obviously the are the and now. samples as, but Vopra that's other we most well one as Yes, interested TIS well that biomarkers, as in baseline study predictive in EMERGE the we're

Operator

of [Operator Instructions] James. comes Raymond the question Your next Seedhouse from Steve from line

Your open. line is

Unidentified Analyst

is on you Steve. for Thank our for This taking questions. Daniel

hi, expressing now showing express patients So compared are also select a the PDX did it's benefits targeting greater and ICOS for biomarker ICOS PDX thoughts biomarker and some PDX to those that inhibitors have for populations after both checkpoint hi? that are on approved are patients in that not you in those what to have

Beth Trehu

sure. Hi,

predictive TIS So a recall if PDX as developed you biomarker for was originally inhibitors. that

study non an unselected patient in be do second with line than XXXX we naïve potentially to group. data actually better small expect PDX the lung the cancer So JTX SELECT cell

as scores looking at that will We in be at baseline study. PD-LX well

it how you're, compare asking positive study to selection it important you're criteria. us us And a overlap so demonstrate, demonstrate allow much take the would a plus give important that superiority Vopra XXXX question should selected of forward, for very is PD-LX want to the there we that to versus trials But and good to a The is Vopra sense alone. is. this should combination how we've designed to if us of XXXX very threshold the understand TIS

development from we will which data study, inform be path will that important to forward. so the very And generate

PDX inhibitor IO a inhibitor Rich Vopra has the to really and Because partner as patient in therefore As to a we've that alone, we free date position study something. toxicity in PDX know chemo to nice combination different population. and said, types choice it not be we believe the with selected add would Vopra many would combination, very a combination of for any patients tumor added want you this

Rich Murray

that. Maybe just to adding comment a

selection look at to that says this we way and threshold need response biomarker that that, hi look the of enrichment PD-LXstanding top TIS magnitude kind So is cells that CDX detection. the in we then we that. terms the to but that expect built PDX in of at link we Vopra the to But expect of on for of for the ICOS

So randomized on will just just that the for of would we're And combo. that, kind tuning then top PD-X, and of be the PD-X at we which for trial be Vopra. hence the doing, looking

the nature the think will fits perfectly with trial. been utilized be a has doing we randomized the So of concept of how biomarker

Unidentified Analyst

it, understand. I up got you, one follow Okay, thank quick question. And

does mentioned are to the You to second be to a And apply second confirm lung above just cell as only non-small or line non-small XX% approximately number line that biomarker whole. of off. cut estimated cell lung that the population cancer patients patients to cancer

Beth Trehu

that's naive the second specific String cancer from patients. cell to that that it's have Nano the So actually and we line lung non-small data PD-X

to our understand since that's but So with understand we're that -- the the was prevalence priority population. first the other in doing population, that patient we're frequency in subject study the them areas, and working the to

Operator

thank gentlemen program. and for participating the This you does in Ladies conference. today's conclude

good have a day. And disconnect. You may now

Jounce Therapeutics (JNCE) 27 Feb 202019 Q4 Earnings call transcript