FPRX - Earnings call transcript Q1 2019 | Five Prime Therapeutics, Inc.

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Operator

Welcome to the Five Prime Therapeutics First Quarter 2019 Earnings Call.

As a reminder, this conference call is being recorded. I'd like now to introduce your host for today's conference, Martin Forrest, Vice President, Investor Relations and Corporate Communications.

You may begin your conference.

Martin Forrest

Thank you, Lee. thank joining and today. everyone, afternoon, you us for Good website. quarter the was be A company with first found financial our can press release and company's results today issued on earlier

indicated Executive Joining Litigation of Officer; Officer; me Reform David Financial include Factors may by and Act call development programs Chief XXXX, Today's financial Smith, differ Aron the forward-looking statements to today Knickerbocker, statements from and results factors, Dr. in those our Collins, forward-looking regarding under those research our Chief are filings. Helen Medical conference numerous will these Officer. outlook. and including due section Chief statements discussed Actual Private SEC including the of Securities Risk

expectations could and Our assumptions change.

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

Aron Knickerbocker

thanks we'll in the our the during us for provide Good joining today with cash early will our other Martin. an guidance for further for the On we quarter, details our the review the year. first afternoon the the recap And as along out call to add quarter trial. turn today, FIGHT including will to the that, Thanks, futility an to I'll for Helen call achievements first highlights programs. the biomarker and FIGHT review quarter well and decision progress are analysis of David update on as seeing clinical to trial our data provide on financial Q&A. after results XXXX.

Okay.

that modified or chemotherapy in than FIGHT or overexpress bema cancer, gastroesophageal combination whose What learned in trial, patients Let's with which is and gastric is with recently testing of we've expected patients original IHC tests. FGFRXb in the get positive FGFRXb. tumors by significantly We than greater GEJ, had junction, with patients by bemarituzumab FOLFOXX either frontline have screened for our higher for the and/or expectations. which overexpression positive of alone, to enrollment XX% test trial tested FIGHT IHC ctDNA is started XX%

that also represent overexpression trial. in biomarker-positive of expectations, patients FGFRXb to vast the for trial, these the patients patient enrolled patients the majority we of IHC have expected would positive a in our We of Because decided the alone who minority patients but enrolled the the an conduct differs from represent tested FIGHT analysis. we early by composition population futility FIGHT

have due proportion suggests that be than After gene patients Our other review, trial stability and the to IHC a we're demonstrate greater and these that a comprehensive whose have using appropriate in and their tests FIGHT to enrolling trial data both and trained early properly been the overexpressing amplification. monitored. labs a specificity, are we're and screening assays that of may reason FGFRXb undergone the FIGHT tumors confident ongoing sensitivity, the ctDNA testing performing precision

FGFRXb samples the of FGFRX concordance that performance by copies overexpressing and words, is testing negative the ctDNA labs the findings problem the the blood. across other for of suggests are tumors Additionally, X In extra we global IHC of are implementation by and not there think positive truly negative the gene tests. with testing tumors of presence a blood in truly central

occur we early and figures first both this larger We fiscally X we continuing the gene be who FGFRXb overexpress in for the XX% cases. the patients believe current In expect the planning population patient XXXX. cancer assumption futility FIGHT which base which in futility biomarker enrolling to half are amplification. in While the all that FIGHT appears trial, on than be we have that X trial Based our for original patients. the estimate X are than patients that outcomes cancer different it decision the analysis then of be represents the would of than clinical that the of XX This additional the being clinical of clinically made advanced In of in appropriate FIGHT may do unknown data for to from time absence positivity, may results, screening gastric light rather gastric on an from in the we because trial enrolled patients the approximately support significantly GEJ design. bemarituzumab the and is patient believe patients responsible. biomarker conceivable limited it may event of and we've bema approximately benefit we initial conduct at late-line an of bema, the in addressable population analysis,

the back our We Horizon oral briefly session CDXX-Fc call in I'll first-in-class participated fusion New FPTXXX, from Helen's presentation FIGHT during the now the In the March, the come so Drugs update, to AACR other we later podium recap quarter. protein. trial delivered on in a on highlights and clinical will at

to FPAXXX, our BX-HX has meeting accepted upcoming for at ESMO data poster We track for Meeting. abstract Ia/Ib first-in-class second a remain in October. on Phase presentation Our the antibody, make at Annual on a the presentation been ASCO FPAXXX

activity We monotherapy the trial, data. preliminary along present patients for with to Phase monotherapy safety expect in data FPAXXX all I efficacy

expect of the to preliminary and combination from Phase I FPAXXX also present We KEYTRUDA. data safety

new pursue progress for to resigned complete monoclonal fusion Officer, the call, Phase of November. combination a Chief on present and to cabira now disappointed of being in leave randomized to held to an to fully wish immune on We're in in novel With also reassigned and cancer conference controlled on II much is of Bryan escalation enrolling, we a executive continues commence a to TIM-X, organization, antibody is uniformly of dose preliminary of Bryan immunotherapy BMS-XXXXXX, research organization our with Bryan studied update human announce search partnered the Helen. Five Five with new this over our and biotech privately we basis. community valued executive leaders currently space. Phase targeting research the on call a Prime OPDIVO with a in first-in-class and team, interim Prime, The company Irving, Prime receptor, I'm the a research senior him Bryan for the strong but have in-depth that in BMS-sponsored trial scientist pleased see fully provided the Ia CDXX-Fc success well. member his our I/II technologies pancreatic protein checkpoint our wider a as of organization an last Research. year. I'll cancer data second-line OPDIVO. to We're is a opportunity sad trial a the enrollment working turn now at Head within Scientific our strong on his Five Bryan expect venture. in top-notch to and programs has its partners. SITC an to and has built the corporate been see promptly and to track responsibilities trial FPTXXX an plan We We Phase that, academic are of progress and admired

Dr. Helen Collins

we team due our has trial, Thank also I'd an you, investigators, the of Aron. of a comments clinical result support the by from move higher on FGFRXb-positive FIGHT FIGHT of predicted. The Aron's to as update pipeline. like prevalence about enrolling and execution great well our been trial then patients to to that on build the

so this biomarker-driven testing it reminder, prescreened remain we As the placebo-controlled or of point, test in And double-blind, XX% IHC their in FIGHT tissue the a rate number FGFRXb. ctDNA screened is are It's outcomes. positive. we're based be expressing are by on either the biomarker and a patients anticipated by XX% we is positive. Instead, a of biomarker trial, test. patients approximately time, early very review positive to therefore, and the than able blinded the And the trial trial, we to, of greater at patients blood trial observing tumors will real of the

Xx hand, we the addressable than what might for bema one On population be predicted. the higher

On analysis. hand, the think the than relative subgroups are of in it's data be for at to trial of look what benefit futility as by the prudent each we level on an enrolling And the different adding add it trial. we of predicted, successful, the the to other depends the earlier proportions

we're let of you So the walk of what me through details some seeing.

tumor and qualify positive test based And FIGHT gastric sample in global test positive, for patients by FIGHT their test who by test of their subgroups: trial cancer is and on in biopsy blood positive. Patients FGFRX over X gene or IHC tumor how circulating of test FIGHT both this patients tumor, trial trial. either are a what staining, or The FGFRXb positive test amplification qualified X blood I'll a for overexpression frontline we've for of their the of into ctDNA tumor positive using their FGFRXb seen patients so Accordingly, the DNA. or for enrollment for of the most immunohistochemical in First, the are patients the first XX% the trial fall setting having FGFRXb. on far, large-scale, using blood overexpression the alone. doing enroll screening screening the tumor tumor basis into having of their review positive or IHC,

any their observing is between design patients We out FGFRX most that enrolled has positive. both patient what This have what for tumors trial must blood tested in upon we're more predicted is based trial their test tumor I and important that we significantly predicted would where overexpression gene difference and data the incorrectly. that we of have positive historical and FGFRXb concern patients' point no our there because the both amplification.

DMC, The already reasons thing proceeding DMC reviews aware reviewed they trial design. FGFRXb first are trial of gastric seeing unblinded had monitoring the commercially of trial found cancer positive the in to which prevalence This stage confidence setting. evaluated our XX% assay. means is tumors FGFRXb IHC the frontline most versus partner unknown overexpression therapy that as hypothesis, cohort that just of confident might the we're data more overall is a of going and of of themselves observation are did the to as of data used that the and the for frequency IHC-positive performing and to with tumor the this we IHC they found continues were be data, independent differences first tests recently line we the tests. patients late-line in provide designed fact, favor The the And any and changes mentioned, truly that to course, overexpression of screening larger what further risk/benefit committee that the In this likely through twice these of the higher the due to samples setting diagnostic our we overexpression. are Supporting than the cancer. Aron frontline diagnostic is. and prevalence, subset in the as they higher the in the not develop compared recommend be are These for samples biomarker In gastric determine of results. sourced than for a in frontline population meeting, explanation

by this So the and new data question a is raised perspective. trial from statistical design

of the proportion Assuming to more may the likely patients addition endpoint. of of subgroups less make could the different chemo, in achieve different or either amounts it bema change our that enrolled benefit a we from subgroups

it tumor Let what by familiar mutational The lung and in take of to PDL-X minute you're me with: cancer. all that an a and use using explain analogy we're seeing what means biomarkers

to of their antibody, select the a testing efficacy tumors would design trial lung testing If going on PDL-X. you you today, cancer positive based PD-X for patients a were

or based on the patients You tumor's their select burden TMB status. likely mutational also would

If these benefit patients you're burden of have the are positive be different. confident are that that this, although PDL-X benefit falls all both tumor subgroups: your enroll PDL-X in and of X positive, each would is high high that you those have X potential those did those likely subgroups the burden. relative from mutational X and whose that tumor subgroup tumor to into mutational drug, And you to have

estimation their of of TMB you data benefit expect based each estimation studies. subgroup most benefit that an Nonetheless, each a enrollment know PDL-X less of status and expected see make retrospective about the but patients benefit and an Additionally, from you comes about subgroup your status, know of in accordingly. lot the to size of since the on in trial you you

trial your properly. estimations, right the make you sized be should If

was benefit our So analogy both gene of subgroups in X amplification. trial to that overexpression FGFRXb data FGFRX patients the based bema trial, majority and for it. on design FIGHT the in but we back tested bringing enrolling who this much on the the to, supports There's less positive data of trial this other of

with demonstrated has with cancer literature overexpressing to is in chemotherapy FGFRXb a because the have that continue all single-agent qualifying of and the to analysis the to overlapping evaluation. end of we'll large selected a is less the of point. independent cancer. prognostic KEYNOTE-XXX, discussed tough for We We this of announcement that poor toxicity this it's that reassurance we failure success recent our gastric had think so, likely activity, factor, drugs the analysis adding already should announcement for wisdom they're a patients KEYTRUDA bema all Merck's futility gastric we the Doing addition think some we remain trial have overexpression frontline its cancer have suggesting with PDL-X and frontline use the final patients potential trial prudent failed, trial FGFRXb We add potential and it's benefit and cancer underscores gastric was with Many confident trial, the have bema. analysis. the know included in most from the an not treat. this in that but miss concept. also is DMC, an of the interim agreement We futility earlier in to

stated futility to any like And continue analysis will trial futility read the outcome analysis, Aron's we trial. of lead in the this a expect the is, half As trial to first out the as XXXX. amend recommendation or to stop with the remarks,

data and Moving a target mechanisms BX-HX enhancing frequently T designed tumor sending is our first-in-class endometrial in PK program that for BX-HX BX-HX accepted and are to and overexpressing CDX second The XX year, from X on at FPAXXX pleased of of exploratory We're antibody. preliminary By doses and poster antibody make solid at and overexpressed ovarian breast, ADCC. our been enhanced any data BX-HX-positive time ASCO, first is dose to we This BX-HX will our FPAXXX cells teams study to is signal X clinical will patients. the inhibitory cells for include to data some and tumor, ESMO. safety will in blocking be cancers. from escalation be that an of ASCO through solid tumors first this at killing FPAXXX, the and kilogram by presentation tumor, from at action: in at excuse I me, this ASCO X Phase has disclosures a the per through presentation data preparing the clinical which data cohort and the milligrams reporting from

testing XX the to in year and patient of this available in ESMO, from the KEYTRUDA-FPAXXX activity preclinical in You'll recall kilogram patients on drug, we of cancer to cohorts the with that the screening FPAXXX the month. antibodies. the we dose data this combination. with anti-PD-X expansion the will plan present monotherapy combination PD-X ovarian of expect be our on from the enroll first data at overexpressing per at Later combination full milligram and safety preliminary KEYTRUDA BX-HX We've recently KEYTRUDA, based the opened BX-HX synergistic data combination for supporting and

and SITC immune This a approach CDXX we reponse the for CDXX the which in FPTXXX a protein, through present that Accordingly, our of stimulation the plan We're late acts spectrum superagonism, progress presence data types. T-cell FPTXXX. against enhance in first-in-class first-generation the unresponsive to in employs making that dose conjunction to preliminary to approach tumors to immuno-oncology co-stimulate antigen. novel may FPTXXX tumor are a is without safety of with to T-cells which escalation, activity good Turning an is has fusion broad therapies. to exciting receptor at target CDXX-Fc potential November.

has our our and inhibits is block to the been macrophages. that to of activation turning partner and shown tumor-associated programs. antibody survival Finally, Cabiralizumab CSFXR

into in Phase pancreatic randomized with cancer trial BMS, Our global a is patients, development advanced has planned XXX II of which ongoing. cabira partner,

list of posted Additionally, to variety peripheral they just in and combination of T-cell add IST continue week. therapies tumor this trials lymphoma to their investigator-sponsored in past having a another types,

II Phase trial You over will now we program I to call partner I'll also that the David. and recall and BMS their TIM-X, targeting another have is turn ongoing. with

David Smith

cabira force the diagnostic no primarily reflects a issued II in QX $XX.X XX, expected afternoon. can securities flat first companion this related December and to combination program. result incurred $XX upon expenses a with Thank lower were quarter quarter was XXXX along of details as XXX, to cabiralizumab partially compared $X.X million, XXXX other license and which results earlier our financial G&A initiation the collaboration and per with in Phase in related decrease on offset in corresponding revenues. by strong our without a the $XX.X press of This million quarter the that March operating manufacturing the costs decrease milestone sheet. expense BMS's the expenses first compensation and of quarter equivalents to totaled for of of agreement clinical cabira were were and XXXX the share. costs trial pancreatic under year's ended on testing was expenses quarter. agreement, in FPAXXX of the second-line This million quarter Helen. diluted quarter that in with expenses million with XXXX. The Collaboration the development cancer. that quarter we complete collaboration and for Cash, XXXX, reduction higher This exceeded expense our $XX.X on lower in million million million the during compared of decrease for its Research was prior to totaled We first marketable XXXX, that XX%. the first in loss quarter earned chemotherapy $XX.X nivolumab clinical and over or million, $XX.X $XX.X million balance The release $X.XX be of which we trial you, cash year-over-year. last net XX, first $XXX.X the included like million is over revenue basic of a a decrease with found revenue quarter $XXX or

XXXX operating to million continue range cash million. of activities in we year We estimate equivalents used to ahead, to million marketable full in $XXX ending approximately Looking net cash, $XXX in XXXX $XXX with the and to securities. million expect be $XXX cash

the the for turn call back I'll Q&A. Now to operator

Operator

And Cowen. from Shibutani question Chris your Instructions] from first [Operator is

Chris Shibutani

to you a explanation and one that Appreciated shows analysis what think are this that is enroll if of take and subgroups way about of do key if I being other for the currently decision dosing Helen, futility trial amend the instance, it need if when be can think trial just things the in careful of not terms would about further, run? as And Great. the can we analysis. to the for the how further, variables of we that you sizing? like, confirm implication tree in the be factors that leverage a would is ask, you would, the what way or such little would terms bit the

Dr. Helen Collins

Yes. early trial. Yes, it's very in I again, think, the Chris,

to overexpression purposely ToGA, So could mostly mean, patients that some FISH, by have of the what expression, were, you group, in here are were the without enrolled we're time, surface. the and most you will, we're the there is ways, we amplification do imagine, the So it's all you again, we what I is again were from ctDNA we look assay. right? how our least ironically, at we concerned happening confounding cell can the data who is with We from is if, patients piece drug see right? can because, what if that's late-line works, seeing added had we as are is at, beginning, works from trial. at, who been that both identified and on the know you concern that some overexpressing that of good in amplification, that overexpression. can same disparity, have know, had patients amplification just drug we because the just we HERX, we do that know you've at confident I I say using But this know, and want, think We but in I right? beginning, the, look our instead every but Our following about, our because

from that, amplified, of to again, know that futility, maybe amplified-only tell. a to just I, we the proportion I'm I in and but as going getting answer early I getting terms isn't I it has to you I patients think long right? the have, they're directly I'm So If depend, be So then a benefit your call, If of, doesn't well, could be huge going infeasible it question, the short right? make larger. answer information patients small again, trial benefit, see smaller. we're it's we trial that's to lots can mean, that depends, mean, the how afraid to I, have then Too as of right? they're the

Chris Shibutani

it the And think of you aimed at clinically, when line. asset about designed to few address of trajectory thought more FIGHT I developing originally line was and this a think it I was back, and about later how patients years more front

in analysis development And moving additional in with continue therapy? that but scenario what futility it's clinical to or and of setting, feasible a still you prudent lines bema top continuing upon know or later with to indicates that be a to based line learning what path we event pursuing the you're and, you get do not the so

Dr. Helen Collins

and other that there the amplify also shows, would data mean, and FGFRX, I are the on it on data potentially, show. again, so Certainly, what right? depend overexpress depend again will it what tumors But

Chris Shibutani

update this? that's and on on commentary recently that Lab. regards to Should program Zai there the analyst Got in don't with partnered you think we a communication count it. decision primarily this an meeting. And is guys coming any or to, hosted making from I They this. any was

Aron Knickerbocker

Chris, Well, Aron. it's

Zai. in well. with of with aware as onboard plan fully this. close this communication are They're They're We

in with but We do worldwide, coordination Zai. we are the global study so sponsor

Dr. Helen Collins

less these it's line? be indicator. see all these I could more to patients mean a in poor one front prognostic are are make hypotheses. hypotheses, it right? I other again, and again, you on. And Could late these it thing. And mean don't try so, but that line why and mean, overexpression would and the later I you all think

So...

Operator

Your Michael from is question next Schmidt Guggenheim. from

Michael Schmidt

trying couple pattern? one, whether then follow-ups to seen for guess, maybe regional you've example, have bema. just a been on I'm understand, today, maybe patients how share differences, any could Maybe expression number you screened I in many

Dr. Helen Collins

on we're the trial. a early at based enrollment is it's It the that few looking primarily, in So is on countries.

So saying That's that is why of the we're limitations it's early. data.

it's whether So too regional early differences. say just to for us there's

Michael Schmidt

could did maybe did we make for, in It how you Understood. biomarker both And efficacy or relative your subcategories. contribution only amplification if test maybe IHC in on guess, actually, assumptions did wondering And remind I whether see then some us about and those should sounded you or say you DNA like in maybe. fact, different comment. efficacy relative differences you those when subgroups study positive X powering the in think either just efficacy

Dr. Helen Collins

So no.

So that's a great question.

So more I the think of it's about really data. confidence the

Phase our this So use just most, didn't we trial, when we designed I. we,

FGFRX we amplification. X,XXX closely partners, and to I who pick then worked that data. We used preclinical the There action. used And have be, used mechanism souced samples, the are may data clinical data. our help of over people literatures. Phase other our used commercially our looked looked with various we cutoffs. We So We at very diagnostic at expression our us there in also

that's group, the of our but on So, them, the, double we that positive is. where data have call I'm of most all going based confidence a to that,

less so the we our data other. is of It's in just group where smaller. our that than that case, and think one not is, So much that is group that's patients it's

some that a confidence issue, So so Does can benefit. you I it's not that really relative much help? there's tell

Michael Schmidt

some if of lines Are Chris' could metrics then analysis. Yes, share futility along us And there the I the disclose? the, could maybe that just question, guess, yes. understood. you And, maybe of you any

Dr. Helen Collins

Yes. off this is the information press. so hot Well,

through to make thing we're and so needed about discuss it, DMC, analysis. now. that's with decision futility that our details first we working And what do to our the to was so And to with those and a

right aligned the is haven't XXXX. everybody have early that earlier think planned details, do we want than to and the analysis I our now, we we much public. But for been this that that's interim doing made would

Michael Schmidt

on just the Yes. then ASCO maybe one upcoming And for presentation FPAXXX.

to higher safety patients if us but trying doses, know curious I at guess, It presentation, we could a so at on just I might understand. may like a PK maybe understand, there help patients or efficacy and of have was I some be Just been of it's ASCO. primarily as early well fair anything whether, sounds treated glean amount signs

Dr. Helen Collins

Yes.

I it's think the the of data. timing

this So happily, this trial, went extremely escalation quickly. dose

know, months, X you in less X, cohorts. we As went through X than

beginning, have efficacy. those at higher-dose to we first there patients so on durability dosed And were just the time in the be to of have quarter, the so don't able the

issue. So that's the

So safety data. that's why this is

dosed able the are of patients data. some right, be we us to to You're present any time dose, higher at that but don't have the on there for

Operator

from Chang Jonathan SVB from is question next your Leerink. And

Jonathan Chang

the confident about the stage sense is data than up on to number representative number XX% expected. FIGHT Michael's originally Can trying the a are question how talk set is given get the on the following XX% of study? more And early you study. that I'm Just you how large broadly the of

Dr. Helen Collins

on hundreds XX%. and but little we the our, enrollment our range, So prescreen less and, is than a

on a that trial for numbers going. ones small those again, of size. this So nothing countries a And got concentrated are few because the

early. is it So

Jonathan Chang

Got question. second it. And just then

greater reasons there the the mean do here? for remarks you about know expression gene in mentioned FGFRXb what the be You mechanism to amplification. in I could we that? more color Could of add prepared that absence

Aron Knickerbocker

So...

Dr. Helen Collins

go. may you Well,

Aron Knickerbocker

Jonathan. Thanks, Yes.

really but, point, data, your limited. to We it's have some Helen's,

preclinical the it's But the not in have. some target and showing clinical tumors activity not preponderance overexpressed. do have data Some that that that have data gene with, amplification we

proportionality these come up. matters why that's so And

Dr. Helen Collins

the The the more to back confident go are. I'll again, And more Yes. that have, data have. you you confidence you

is work. And be but bit then of other trials. then continued data I interval confidence it group I to have that it's, mentioned, failures should wider. you But And so think of and on the a it's data frontline little as still a that's, that your honest, also

failed. trial this started we since Merck's trial Gilead's The has So failed. trial,

safety lead-in. the The failed. You're started right trial in about ramu the time we frontline

So thing tumor, other the prudent at I that a a when is right? company the you're gastric prudent, also we for when it think looking and also tough do cancer. And It's we think in so prudent have pipeline. the things to just say we

Jonathan Chang

And... it. Got

Aron Knickerbocker

clinical number analysis. This our transparent; to discipline. number early really to with take still to desire drug the think today fiscal investigation, demonstrate announcement think futility this and appropriate But also decision two, look good and and our the that we it's we merits be one, reflect

Jonathan Chang

it. Got

Can about on talk may, Just the of one if do the study? OPDIVO know combination last PT-cell? I the on in question, PT-cell rationale added And for you cabira about role clinicaltrials.gov. what this CSFXR study we recently

Dr. Helen Collins

I let right, that's University and done I at a this me, is, supporting Well, is mean, BMS being it. Michigan, again, mean, study of

So these expression. it's, involved picking peripheral any have this why I of aware they're But knowledge data will a way. the of in stem partnership, T-cell, any directly some you looking to specific am some on subtypes if is macrophages. Bryan, at of of the We about we, CSFX we're I not although of cells, in talked it's speak lymphoma, yes.

Bryan Irving

the, of aware by could rationale. strong I'm No, be it. there surprised not I'm just

Dr. Helen Collins

Yes. Yes.

Operator

is Richter question from next Goldman Your from Sachs. Salveen

Maryana Breitman

going the a are have trial I analysis futility Salveen. statistical for design? Breitman quick that into Maryana change the question. is the Would This considerations

Dr. Helen Collins

the, no. No, No.

can I had imagine initially and futility discussion is analysis. this we lot trial you one about So, again, a thing mean, for of size, a

the it's this right, data this. do made ways, I just to in coming all thinking were it, just, about we made think but I'm, So need is we in us, something some

not analysis. change it So, the but no, statistical would

Maryana Breitman

understand to it. also, And Got also little I bit. a wanted

already? you And so How now from enrolling at looking the are prior? that right how they you're or have are that the patients enrolled ones were different different

Dr. Helen Collins

difference the there I Phase are the, that and Phase trial, in the I, between late-line that again, III trial, our the different, our is FIGHT Phase So was patients.

So or therapies, had was, amplified at chemotherapy. were versus line, who our And patients the right? them those were front that in those So FISH. late both we positive X it X in patients, general, the getting and patients were right? that not getting were And monotherapy added line are Those looked IHC of by again, it monotherapy, they was patients and majority trial.

were. them of most but everybody not So

So allowed overexpressing testing amplified again that, ctDNA, designed trial, FISH. either overexpressing it we're patients amplification. who by when works, this overexpression, the the how by again, knowing or or requires that we And not are and we amplification, drug

Maryana Breitman

And and looking FGFR cancer. think you seeing. for are sort it. all of were I right that this like is is it's lot people who a now, more in I, wider a phenomenon Got the, And at of much then there actually

get considering some And trying to you want to Or out into what people are Are guys you any just done and combinations. to go figure do next? this combinations?

Dr. Helen Collins

done and need. study our, think I where and it's seen we've an single-agent our our unmet had clearly where we Well, efficacy, is this

those as So be But to our idea was where start of could certainly, And important. with right, other diseases interest are you're is this. FGFRX there well.

that this I we Shibutani's that but it this. question are agree I frontline informs to And think goes hoping with just the indications Chris for data back cancer from gastric other not potential you.

cancer, such tumors FGFR are does is bladder think as tumors and different driver think why of it's, inhibition the study proceed. people and Slightly mechanism. recently believe other why a looking we is should right? and this our that I speak at still we there study good to it other are successful being a But that peripheral

Operator

Seedhouse from is question James. Steve from next Raymond Your

Unidentified Analyst

successful, This forward My is diagnostic? discrepancy so Seedhouse the the the patients? any bema explanation would are us Steve as IHC on analysis. detail there the move more IHC-positive but Dashmer] questions on is you at give if Raymond futility why many ctDNA-negative [Brian with And the James. and were regarding just for you the and companion for trial Can

Dr. Helen Collins

the of patient think the overexpress we truly believe do line. FGFRXb reason is they more than the trial, we gone And because, and we is So of we look and we rate that our discussed, the in when are found one in a closely meaning they different, patients were partner that the late front patients frontline and as the of do we right? screen you that do in groups that that, the again, patients found other who cohort the populations double that IHC patients possible So seeing matched in line, the than at were things also more who are because as has enrolling stage, that believe FGFRXb. advanced as

supports So concept. that that sort of

published on test that. test you ctDNA you, have because And into we've when dying tumor. from think to the appears our to wondered, has may that relies patient bloodstream cells blood the need be be I not The patients do received shedding I some the recent suggest that DNA of who if okay, because a any therapy, know, as you less ctDNA shedding mean, honest data about back also I'll you have, are up. there

accurate, test may shedding it that. though see So that even the tumor, is certainly be into you won't no itself

to to dataset. difference, is these be everything can't, largest in the a patients no going But DNA. the other patients. positive We going cancer not up ever is this right? that is that's But FGFRXb again, gastric because are and majority vast, There the not of alone. hypothetical, vast otherwise, You're picking dataset make larger huge frontline

Unidentified Analyst

will think And that's... be, I there

Dr. Helen Collins

Because especially doing validated truly oh, tests through CDx want validated, for that's with sure with tests, of we're you the especially potentially a that time people development make a the all the we're right? approved. this, spend the that the using gone have we're to And people done steps and first that to process done first

But is very what this the we're successful. more means will I you Very it can't or in study confident what to again, early. likely whether data. So early. it's less for be And be tell

Unidentified Analyst

individual tend to prespecified response by Okay. subgroup each their biomarker? Are there look they analysis

Dr. Helen Collins

not your biomarkers. have but stratification, what patients some by stratified have now, stratification. of by again, the We number limited, Right you're and we

to but all So retrospectively, chose certainly on this. not look we do they Retrospectively, sorts would did, prospectively. We regulatory not at we always of stratify subgroups expect that. agencies based

Unidentified Analyst

any manufacturer Okay. anticipate it in aggregation quickly FPTXXX. or you proteolytic with specifically And stability associated ability degradation? terms then regarding issues real and of on Do

Aron Knickerbocker

been a by not limited It's we've drug No. problem and so supply. not far, been

Bryan Irving

Or with aggregation problem.

Dr. Helen Collins

the moving It's with along. pleased We're trial. Yes.

Operator

question from Joseph is from next JPMorgan. Eric Your

Turner Kufe

mentioned percent what for both? you percent is curious if were FGFRX quantify specifically can percent patients I you positive. on what of than XX% This greater amplifiers Turner that were I'm around, Eric. and alone, what know was was by IHC

Dr. Helen Collins

done because, Well, the reason is is we the small. so data again, haven't that

enrolled countries So XX%. few a just we've because than And countries. way course, the slightly few that very if don't earlier these of usually It's now, less know heard things comment. that's sites work. Right in means I a in few concentrated a the you

these So not big right people. giving we're on purpose just numbers to now because we want don't mislead

XX% the So of one other, than it's most test far, by are of and on are based the FGFRXb and patients alone. or more them the qualifying

statistical it's not, that, those accuracy what wouldn't and there I'm because are other than around just sorry, I'm telling what be I'm So what you.

I'm early. So be trying evasive. to not too It's just

Turner Kufe

high so maybe then you From of understood. Okay. samples, cutoffs. know the Or were And they around there that some kind enough? of just internal Or not I'm were samples or combination I these you curious. they were primarily frontline? X,XXX Was threshold determine both? later-line mentioned patients?

Dr. Helen Collins

that you Yes. double than back, back they're rate are, through our getting X,XXX-plus stage? you samples, results went those When de-identified, that do started you the see that more the There that's know them. IHC what they're to that where get don't is out can most right? you they we commercial don't part, So you they these do partner know said, and do look we these why advanced frontline, we could And those subgroup. that's if call saw And know and for did you about in samples anything we completely is, when know.

FGFRXb positivity. double the than more So of rate

Turner Kufe

And your was validated kind what one. Great. you about that one specifically? gives how Okay. of you quick then just assays levels? were talk you I they appropriately curious. confidence measuring And FGFR Can maybe last

Dr. Helen Collins

previously Well, I we've with announced Ventana. think we that work

make one sure in if point both of the specific. assay not point about They've should of our is, They they through the whole standard the in reader we've tests. their from whole met inter-reader testing, very as do There's of a are assay control. the reproducible sure leaders, obviously they different things of leader, bring series and make through a they're I testing, that So biomarker to the development SEDAR the IHC view. plans. design go meaning view with things of list from that for And of said, person. go day trying to

develop appropriate the through gone they've are, steps, again, the to these So IUO.

So...

Operator

Sachs. we have Richter follow-up And question a from from Salveen Goldman

Salveen Richter

quickly There going based wanted prior? on to based that, I be not just to particular ask. I on OpEx any right? mean, contingencies is exchanges

Aron Knickerbocker

[indiscernible] expense again. operating changes? be Will there

David Smith

those expense No. We've changes. our not kept [indiscernible]. if any cash utilization There guidance be will operating consistent for

Operator

turn Knickerbocker [Operator the at closing am to Instructions] showing I no Aron conference time. question I back further this to like for remarks. would

Aron Knickerbocker

our we information of partners today. we're We call, decision-making about pipeline, new the following beginning you've III to Phase continue the the FIGHT progress. from steady said confident disciplined a swiftly progress to as advancing at the make in science pipeline, we're committed underpinning and and heard I and As trial, our to our remain responding

Prime also joining of We you today. clear updating have you Thank to in trials, investigators we I'd patients our our exercise and hurdles And the Five advancement pipeline all fiscal participating of to the you. June. many during to discipline. continued ASCO like employees we conferences forward at to that thank clinical seeing gauge like of ongoing one And investor I'd thank for look and the of to our and be programs who us you strategic our collaborators that, calls. look With to contributed to advancement clinical programs. forward month attending at the of future the our will all and on we our

Operator

have Ladies today's your day. for and and this Thank concludes gentlemen, you wonderful conference. participation, a

You may all disconnect.

Five Prime Therapeutics (FPRX) 9 May 192019 Q1 Earnings call transcript