FPRX - Earnings call transcript Q2 2019 | Five Prime Therapeutics, Inc.

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Operator

Welcome to the Five Prime Therapeutics Second 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.

Martin Forrest

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

Executive me Officer; Officer; Joining David Financial Chief Smith, Aron are Knickerbocker, and Dr. Collins, Chief today Helen Medical Officer. Chief

indicated Private differ financial statements the these conference research regarding those by the statements and call from outlook. Act to Reform development including of forward-looking include Litigation Today's and Actual Risk our our may results of those will programs due factors, statements under Securities XXXX, section forward-looking filings. Factors including SEC numerous in discussed

change. expectations assumptions could Our and

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

turn call will to Aron. I over the now

Aron Knickerbocker

and on and afternoon disciplined quarter the during for events to say data clinical thanks and upcoming to where today to pipeline that milestones. pleased driven will joining investments. in second progress our data allow to prioritize make I'm track Good us all Martin. we’re are Thanks, entering review a achievements period and decisions upcoming preview us programs

Five Prime bemarituzumab the most our trial; current controlled priorities in and the and are; promising for two, one, advancing three, opportunities; FPTXXX. assets, FIGHT FPAXXX safety the finding For dose

that gastric new prognosis. with agent Okay over expressed for targeted patients frequently why by is bema's cancer. cancer a specifically we important is protein recapping and associated be which let is the an medicine is start potential with me remained to in confident pour to that about Bema FGFRXb, gastro binds

cancer gastric monotherapy clear and demonstrated study gastrpesphageal and activity X Phase heavily bema pretreated patients. junction The

that an was trough regimen X achieved XX% the that the in was and also rate disease monotherapy objective without monotherapy study the FIGHT was impressive chemotherapy. Phase rate XX% plasma in the patients achieved, dosing the control For response used who concentration

efficacy we reliably the lead chemotherapy additive know toxicities Now, identified validated through of the safety expressing chemotherapy. and tumor derive standard from identified and models, which no trial trial, have tests will overlapping FOLFOXX FIGHT in who care diagnostic to potentially bema patients into and we’re combining FIGHT FGFRXb bema be were in the benefit molecular developed been with over from modified

way a has therapies expressed also the Herceptin a therapy FGFRXb front relies combination cancer in ToGA and proven Additionally, chemotherapy Herceptin gastric trial. to of binding in works that a bema analog its over in as as protein Herceptin’s with relevant ADCC cancer surface gastric FIGHT the the Herceptin targeted that on for work similar much to the and was trial on of power to binds use and same that design cells quite action. approval resulted mechanisms in one

gastric However activity unlike have not much monotherapy believed bema, in to cancer. is Herceptin

that operations clinical disclosing FIGHT the are in to respect we pleased patients are With enrollment trial, in that milestone today gastric population of the continues plan dosing a patient with we the the ahead in of large first cancer. has which Japan, reached the we and have

early futility enrollment than the have an in This patients and that expected portfolio remained given trial analysis. further. would bema, Helen been analysis we our prioritization, discuss futility on higher support will with conduct enrollment the sufficient we enrolled consistent plan FIGT we about rate, the While emphasis to with plan pause FIGHT the confident trial is in to

programs and occur This driven pause quarter conserve enrollment fourth that the bema, decisions of to to generate pipeline pause to FPAXXX while the FPTXXX we and during prioritize data make data from will investments. We resources expect XXXX.

resume bema adequate enrollment futility we have FIGHT, we drug promptly. analysis in to Assuming have will supply

opportunity substantial one move will with be in bema which patients eligible for represents we reminder, forward, a commercial a we bema, three treatment in cancer if in believe As gastric the increase for United Asia regions about an gastric we potential new Europe to to the continue medicine expectations. versus be with and for important Altogether, bema excited our the patients reasonable be cancer. States,

data upcoming the Meeting September. Turning to we Annual accepted ESMO abstract FPAXXX, has and in will at our present

present at kilogram the cohorts cancers the to over from milligram monotherapy patients Phase endometrial data in breast, Xb expect dose expressing and We expansion per ovarian BX-HX. with XX

data the potential checkpoint that monotherapy While will believe agents. or with focus holds at preclinical other we ESMO, on FPAXXX inhibitors significant combination chemotherapy be data based in

with to studies we're later this of the approaching also we in the begin ovarian cohorts, chemo indications. completion those open expansion the combination If Keytruda that breast lead-in FPAXXX or month. we and/or front expect the safety for monotherapy efficacy endometrial On may additional in of cohort combination and identify checkpoint

Turning to of the in plan fixed Phase dose level escalation the escalation to portion enrollment cohorts with FPTXXX, trial enrolled dose is continuing. X and proceeding dose according

abstract dose have We present at SITC submitted November. data an safety at and pharmacokinetic program from to escalation this

we in and partner imminent our BMS pancreatic actionable For cabira second by year. in OPDIVO next randomized have programs, is completion Phase of cancer enrollment data and the X to expect line trial of

now sponsor human BMS program. Phase TIM-X, combination to steps with disclose clinical trial checkpoint receptor, immune in an And antibody studied and this in to is targeting a BMS next X/X data BMS-XXXXXX, advance appropriate OPDIVO. finally, continues determine when it's and and being a for trial will a by is fully

allow are decisions for driven we data events that As make pipeline prioritize several will data to to disciplined investments. I us mentioned preparing upcoming earlier,

over the And with that, I'll now turn Dr. to Helen. call

Dr. Helen Collins

you, Thank Aron.

means benefit Building overall the enrolment. add on to with an powered last trial of the the detect futility unblinded you modification. to an is comments, the data. double-blind DMC, a to at trial does I'd don't early earlier remind which our continuation which they bema. without ensure review with is reason analysis see Aron's full There adequately trial to independent is the we and trial placebo-controlled is like FIGHT an trial the begin survival data Let's at to a them, FIGHT recommended unblinded meeting

to manage will over event analysis, decision should to we of light patients, and trial number see rapid a plan the and to of that futility approximately quarter, to know either analysis be of data-driven first the frontline is by in events estimate will which FIGHT pause the analysis trial, continue fourth we needed generate sufficient very we're globally XXXX. XX%. XX% will de-risking a outcome fourth the a well setting then of quarter. conduct In FGFRXb enroll as of enrollment our to able utility resources to make enroll our wisely, the We The The trial total to the FIGHT in prevalence the once the trial enrollment of we resume continues desire the of planning the and to discontinue. a enrollment this half crucial be for in during we

entity, improve single of demonstrated patient in Bema is target frontline tolerated, bema the biomarker gastric population. well patients FGFRXb remain, optimistic we for cancer. selected being antibody a in monoclonal over survival potential used expressing a to about And with agent the

designed Moving signal mechanisms and to tumor action, on through inhibitory which an is killing of by T the BX-HX blocking two antibody our of over enhancing FPAXXX to sending from first-in-class cell. to ADCC enhance CDX target BX-HX this tumors antibody, by cells is BX-HX expressing

BX-HX data handful who would had enough over We these and had long monotherapy will preselected early This as approximately single on ESMO only patients as data be to plan second present from a scan expansion endometrial preliminary patients for have and ovarian, expression cohorts. breast most scan. study to across have the XX of the

in anticipate safety also We of enrolled Keytruda the and from four first cohort having data patients the of combination FPAXXX.

activity and data synergy anti-PD-X modest FPAXXX as a chemo additivity with with demonstrate Our same for single agent. preclinical

the For of development component to this believe at antibodies how combination targets directed path used. ultimate be to are similar regimen, reason, we FPAXXX will other solid monoclonal tumor the for

with used in example, For Perjeta and Herceptin are combination chemotherapy.

expansion the combination opening selected with ovarian combination both for ovarian Keytruda of and cancer. go-no-go FPAXXX safety BX-HX efficacy a dosing lead-in initiated the data should make and Keytruda cohort We generate full decision the Keytruda. later in this and we which May, in to doses month, XXXX the a anticipate completing FPAXXX combination In

plans the pharmacokinetic initial for SITC cohort Turning present safety according proceeding escalation the to the dose dose available and November. escalation we expect FPTXXX, is first to to and at

As cytokine and you recall, that superagonism antibody severe in syndrome. T-cell an through resulted CDXX activates release

activation data superagonism. requires T-cell demonstrate should contrast, therefore not with FPTXXX trigger By co-stimulation for preclinical and

early at differentiating levels FPTXXX. dose early support of the and will tolerability safety, feature key syndrome reporting lack of So

will Aron has already turn provided the Smith. partner I to the now call our you CFO, David so an programs, update on

David Smith

and that the We quarter on equivalents and release Thank our Helen. revenues. strong quarter marketable June the on for Cash, afternoon $XXX.X over website. you, The expected other XXXX decrease March issued balance complete of financial XX, XX, quarter This prior XXXX. on to million our operating results million in reflects company compare can found with during this and expenses earlier totaled sheet. that a the the cash QX $XXX ended we details be securities press exceeded

under was expected. per quarter and of revenue $X.XX a second research as $X.X revenues the $XX.X or The March year. is lower per share. year decrease with discovery million diluted was a net last Collaboration loss million the primarily for completion million revenue of This XXXX. term basic prior from of It is the basic $X.X to collaboration was from was the license This the the flat result quarter. and Squibb in collaboration immuno-oncology for and related quarter Bristol-Myers

by and to FPTXXX opening These XXXX. to related cost clinical for of offset partially related trial in million $XX.X $XX.X lower to that sites. compared second drug quarter the cost new lower of primarily higher reductions manufacturing patient cost enrollment FIGHT were expenses This trial. production lower were decrease CRO costs development and well as was and related as the Research to were the of the to related second strong compensation quarter diagnostics million XXXX cost

which million flat $X.X totaled year-over-year. expenses essentially G&A were

go-no-go the equivalents Looking ahead, in We cash, be used that just resources million. closing, through, cash the ending $XXX securities. operating we trial, million to the in XXXX of net FIGHT have take to FTAXXX $XXX continue a $XXX million a for and $XXX year FPGXXX. full in activities with not beyond and XXXX In us will we but estimate approximately to marketable cash decisions to range expect million

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

Operator

you. SVB of from Thank the Our Jonathan comes first [Operator line with question Leerink. Instructions] Chang

Your now line is open.

Jonathan Chang

support on can the rational moment First more pausing the enrolled futility when in analysis? you've provide you trial color to in for FIGHT enough patients the question,

Dr. Helen Collins

absolutely, high Yes, we Helen. for Yes, is qualifying the and number mean based on hi, call, at wanting seeing such I of about sure talked adding This we futility I quarter the -- make trial last when Obviously, Jonathan. while patients to be will think the such that from that, complete the trial be powered a need we make is will we may trial patients bema. that benefit -- to thought scientific successful. rationale enrollment, have to we sure all that we a

it when sites to that point, didn’t and happen at still would a little yet. and bit as really ramping So, any were events in were had haven't up we because we Europe, we vague -- we

when So, end point up now a quick, our where futility we’re futility the we that we And pass. company presuming then prudent like enrollment, reading when know feel so and again that them it’s and enrollment that that we futility, we want can observing, resuming because think we pausing for occur. we on enrollment,

you’d it’s I So, matter portfolio. our about also the our Aron, add like to to -- think a of all rest really of this -- maybe

Aron Knickerbocker

rapidly in that exercising think element event becomes to a pass event we other as once fiscal enrollment. we the to and I and this Yes, the be de-risking the respect discipline whether here position with -- is see a we is portfolio resume would we’re

We and supply we we go enthusiasm to futility. have so passed drug investigator I think have ready

Dr. Helen Collins

imagine contribute Jonathan, out after said, going enrolled QX to the read you are could to you've you futility. the the futility, patients Yes, until

to want we feel that those nice open but for a resume, while we can quickly. things sites So, of be to and essentially be and course, have everything, so we at trials resume quickly we it'd open patients the the yes, enrolling all confident

Jonathan Chang

fourth And you indicated you granularity progress in more compare second enrollment you does space you've question, the XX% on in the to How quarter. your initial heard can versus part? enrollment correctly, provide initial that projections? FIGHT how I've As

Dr. Helen Collins

We exact projections the give made our ever publicly Yes, ToGA trial. about we didn't analogy enrollments. to

it that back partnership. at out And there. to a is go took recall you now to then you competition we fairly may if more have months look access where course, to a X of ToGA there's similarly XX that that know to them was But lot enroll trial, You trial China sized. also the ago XX which and years

So that I guidance we're vague we was previously. kind schedule. of that of that ahead And a decided that gave

Operator

Thank you.

from James. comes question Steve next the Our with of line Seedhouse Raymond

Your line is now open.

Timor Vanicus

on Vanicus Timor Steve Seedhouse. is This for

about questions a bema. have we couple So,

settled how you that on futility terms choosing this hazard in analysis, you the talk And So, some ratio And the will that about factors? you will potential that ratio? used? of of be be have threshold could

Dr. Helen Collins

is jump start can can This and Aron again with I Helen. in. that

is, do we a this but occur that our obviously we that So, that to want we do an what plan to hazard haven't one. ratio than to making do and What definitely recommendation -- less is be it sure that said making there should and conversation have is issue be not there will that there. to DMC, a and is has doing is

sure not sometimes may is to track my just very achieve the about XXX, make benefits, designed isn't that We're what trial, we XXX drug see or concerned What essentially to endpoint. they're make So right. its planed -- set futility, sure its patients with trials really and trying to is that you do sure do powered so this ratio on at an worse that, early is one again we're early to where and show so placebo. is make hazard that than on, want

Aron, add So that? you want to to

Aron Knickerbocker

think I Helen. it. that No, answers Thanks

Timor Vanicus

population could of another had talk versus the patients question, Asian originally? I it see pre-specified you you that mean, recently. process believe informs that was the Okay, about at could thanks. the patients, sounds this it that I like XXX a I a trial? you little And characteristics saw bit you sounded first patient it proportion like about in talk in you more bema look next XXX the enrolled And check-in have you plan. And you now what about guess,

Dr. Helen Collins

similar prevalence you setting saw are talk FGFRXb frontline Asian, about I the we China, QX we tell off proportion ex-China top this a in of I what call patients back seeing of European. it Yes, expression my head can't say that of globally. or are that just can't our over U.S. is and like in that

what So point on geographic in And talked originally we we be enrolled difference tumors. expressing at will we there's seeing, FGFRXb different their based recall, no about where trial the then on the that as over that had areas. are designed you may was patients being

finding on a for were to miss because this drug as might surface ctDNA we of actually see. and expression, more concerned that then is thought it the had that over based just of proxy that we patients biopsies added we we're And are than patients, we what capturing on action, again, want on this would the requires mechanism And over we protein alone. based what the that cell, is expression the

line, than different late patient found population is it but the So, that we I study. Phase our

Aron Knickerbocker

add way I'll pattern. country in serve the and activation the sites have of to just the site West terms that that come East in

America China North South So, and were Europe. opened sites the and then later recently most in first in Korea, in

and XX most And so, countries open it's recent Japan. now to with today is up sites we're and

patients been downward get coming in more entering early a now patients. most is we would So, Korea that's America have and number of China, Europe and now we're skewing a in days of from contributing patients as of trial, South North

is holding as European continue into this be the as So, come change more over to to XX% that positivity said, going at and the rate globe. we around relatively to but consistent patients trial is seems ratio

Timor Vanicus

Okay. Thank And then have we question I quick you. guess, FPTXXX. a do

then but I So, of talked type kind you we the should presentations you. in about presenting some at efficacy think Thank safety that that included of obviously of you since, Is have for forma expect data data. FPAXXX, SITC? terms data per also

Aron Knickerbocker

today ASCO call. time in escalation were dose still at on noted No, as earlier midst with the I the escalations the does We're because filing with of the along presentation. we FPAXXX of

is we're to those levels present we whatever from level, are the dose early dose and escalation. but We and continuing pharmacokinetics have but it's still our sixth safety plan in

Timor Vanicus

Okay, great. Thank you very much.

Aron Knickerbocker

molecule this We to safe CDXX history feel to as in to anybody because new just not with as the that T-cell do module us, QCD it given noted, signal and it given XX act, is safety directed show Helen important acting superagonism. and the which by way is a co-stimulator

prepare result, all, severe, nothing benchmarked at was antibody. to pre-clinically. a we release We As syndrome very that have

about clinic, we versus into going we confident dose need are sell we humans. So, in recognize also the safe to that but that

of practice. is de-risking So, this we for set a data think very important

Operator

Thank you.

question line from with Michael next Guggenheim Our comes the Securities. Schmidt of

is Your open. line now

Charles Xu

on trial. Michael on is questions This -- congrats and off guys. questions Thanks the the Hey, with of a taking Charles I for Schmidt. couple Xu a FIGHT had a just bema start on for clarifying quarter. let's

provide positive by positive wonder you alone, positivity, positive may have incremental of FGFRX or kind could IHC detail the the ctDNA negative On around if ctDNA for tested I percentage just patients and by by of any both? that

Aron Knickerbocker

shared that of with rate on ctDNA positivity going expectations is Yes, haven't seen and It's data previously. published what's we based the -- our study yet. been publicly consistent in

that's is this is up though as more interesting now rates IHC So, now consistently is we what's patients with previous on many expected in the holding well that than study. higher patients with holding up and

Charles Xu

let's question okay. the scheme? modifications how our concentrations. levels may dosing try And Phase certain plasma this to Thank patients maintain was any kind to when some to if then occurred prior modification place of many the that it, may next clarifying you. clarify, taken -- just of have I received Got for and dose X want have

Aron Knickerbocker

tested describe the be portion. it and and to there we tested modification were that the can X in this a Yes, safety we levels how clear, in what with lead-in and forward dose wasn’t Phase dosing the took the scheme I

Dr. Helen Collins

remodels. agent, efficacy obviously predicted had at new phase, the on, there'd can that did the also dose based two based efficacy weeks any and actually chosen single so we may have observed dosing you were and the limiting I patients every we then monotherapy recall say dosed be being not dose that our eventually so toxicity, in Yes, that X Phase on were in

so, went safety C that And do we to one did of of me, when excuse wanted ways. X do. we target to faster is, bema really we what lead-in our can a Phase trough you two we what course our its plus chemotherapy hit -- It and

loading a dose higher can have dose either on can or day You on one day single eight. you a add

two in were cycle on they also except their eight. one dose when extra So day first patients get are treated that every they weeks

the do to retrospectively target our only in on call the this saw being think safety we earnings what XX X looked actually day we chose that what did that retrospective we that they has that trough way it’s it’s by that’s important Aron demonstrated monotherapy so you’ve hit think patients received the Phase trough we to the in is when So since rate at target target look XX% later it’s that the every X we almost trough it’s in response because efficacy. important lead schema. patient and the again we that beginning from And the I this and think achieved the think data data this Phase dosing mentioned we all that’s trial sub-group and patients have achieve actually at supports the so

Charles Xu

call decision Got a you BX-HX kind makes go-no-go this thinking snitched And I sense. much the me. terms you. the mentioned and if regarding briefly wondering guys are XXXX efficacy lead of you about in it, gears just continue? of through kind that earlier question to the in on hope to see benchmarks the with occur then what Shifting that you decision FPA key of safety combination you FPAXXX would Thank your the around very guys go-no-go the last may now bit recall from how

Dr. Helen Collins

we’re see it’s benefit know novel sort little I XX% or inhibitors as a properties that are for that I’ll are checkpoint because breast of endometrial always little there’s this I'm than agent we risk breast think the less to rest mean bit activity negative and maybe there no up seeing of and toxicity. three XX%, reason again a I want the but is start to the section so with of all about obviously ovarian single triple a vague approved cancer and is with Again anecdotally you one the tumors FPAXXX cancer higher these very

with be more if see again of I want obviously what rate. So think questions important that whether is know you drugs the of then so in the a But some tolerated been important a I the arguably, can response don’t - It’s more whole response to really have durability it’s data benchmark than double until PDX activity, really really alone. you checkpoint with as its times at totality Aron and well. really PFS, there’s overall particularly it’s survival might that talking expect you’ve

Operator

Thank you.

line next Our comes Shibutani with Chris of question from the Cowen.

line open. Your is now

Chris Shibutani

of you part thank missed the of the apologies. Great, beginning call. I very much,

haven’t So can topics the raise addressed. hopefully that I already been

So please let do me know.

outlook? with development, some the thinking overall had the about your you make efforts Looking explore How your decisions sort described this are that. What's to relative regard to particular, in of to of see narrow strategy business to you focus feeling to to year? that earlier continued your had a around little bit you've that

Aron Knickerbocker

So of business ongoing development ours. is an focus

access, We also ongoing We spanning provide active But it do collaborative it other an non-diluted been are those. our don't have as guidance strategy we look as now that relationships, we of well. be but has going capital, that part feel to important things assets. forward, will historically, on multiple discussions as

programs, be reach. development and So global broader agents, manufacturing, example, combination that commercial can for

sorts of as the things seek All to those are elements to advance us prem. five we important of and programs

guide an business core development any on is strategy it for active. But we don't And to area the these it discussions programs. how active advance activities. for are us. is We intend So to

Chris Shibutani

that. platforms always of I've the to be further wouldn't asset proteomics Right in out thought that a valuable figuring how terms leverage now,

that your someone announced efforts the recruit opportunity, on role? replace on that update us was to moving you Scientific to also of Officer you've can another year, previously your important this Chief to During status

Aron Knickerbocker

duties Vice meantime, very a search But Yes, Prime. they've Presidents we number interesting incentive of here the at the two search and retained firm, of so a Five assigned we firm have their capable identified that the efforts foster in courts candidates. have hired ongoing, are

of on focused the programs, molecular for research responsibility roughly research one and in organizations, So biotherapeutics stage has group each half our areas. discovery late on the focused biology the other

so, they and to of programs a you ongoing progressing, are but services update result as further. departure. task and still they've really will of And have as the hope nicely none risen the the suffered And we

Chris Shibutani

you then updates and of provided hoping help what Great, that members. of some the about at to shifting in or in decisions of you're some made on Company? insights just components understand terms and us terms you capabilities this you're Can what for those gain you've thinking board of your the relative stage the distribution that

Aron Knickerbocker

to strive case and And the think, a people I that's of Carol Schafer, in Capital role Lexicon Markets, at of what take an companies. experienced been we've board two capital biotech note person the who recent Equity if have in diverse is you've there past. of seen who's We you recently markets added in operational experiences composed a additions, with most backgrounds, in somebody with at also was very Pharmaceuticals Fargo Wells her capabilities. She's financing and to respect

financial so, and to brings capitalize. lot them in depth of acumen getting companies capital and has markets worked of of of a she like ours And awareness terms a finance with number and

So adding that for Carol rationale was the Schafer.

that, built commercial others, and She leader happy in well, drugs depth Lyons-Williams. Dermira different have and we're a commercialized is a important real welcomed She in about companies to at that And but then, commercial and leader capable, also very and market, to and Allergan think I capacity experienced is brands, who's groups, as before profile. how out and launched brought the current currently space dermatology brings and other are Lori reimbursed. commercial acumen

those have members to why to two that's chosen So, our add Board. we

have diverse and we and they really and the additions, just intentionally those Board backgrounds well-rounded given with selected, are think I a capabilities.

Chris Shibutani

should release, Great, a down to expected the to the last mean? asset, and one if What size that I year laser And I'll I've asset. is up. partnered to take apologies, mentioned to XXX. you it TIM-X, from trials the bought one, noticed increased XXX But and is that then again, this we already try in

Aron Knickerbocker

briefly We has Phase it's components. program, and significant multiple it's a X/X fine. No, that's just it mentioned trial and a

combining escalation dose was with anti-TIM-X investment there for is as recombinant hyaluronidase Opdivo initially administration, think program. BMS signifies and subcu continued So then both it with as in potential and well I monotherapy this

pleased We trial. We doing the anything about is what nature divulge with BMS confidential are of the the obviously TIM-X. can't

have to pleased it leave to their that, with program. commitment I this with we're but So,

Operator

Thank you.

Our of next Tony Butler line Capital the from Roth question with Partners. comes

line Your is now open.

Tony Butler

not Helen did hazard Aron, for they new make but opened? recall two Thanks questions. sites sites, ones growing then with also the enrollment would hand-in-hand? if the would clearly some that be I sticking the may to put a than to you very the and reason how have futility conversation excitement you this will to because this but to would and ramping there And so trial, ratio them the case the the before call, you I said much. apologies I you question -- the it, FIGHT because those is pause three Thanks just at how or the around asked number re-enroll wondered you and futility, quarter? question you that communicate were you which what all just to or to the question three for wanted that I When still an know be it occurred want also having you that I guess if is back is, what's And this that or less to for brief fourth clearly about really their with because alluded to but had is importantly actually ratio that's two, one have forgive just put activity, analysis just is, sites importantly did now and arm on has sites, hazard once is asked me missing lot. and last a you communicate

Dr. Helen Collins

Thanks.

So and things start forget. again, those in I'll with Aron will I jump

we're the doing done process public going with the needs So, that terms to we're first when that, of communication the in in in of you. pause, of with conjunction

the the terms fast that's as communicate hear and findings till FGFRXb about of contributed the obviously to that's won't and think We So investigators did to you in hours. them the about confident and of prevalence over enthusiasm study. the enrollment XX that so the

is of and our absolutely to I hazard you think ratio, one. ratio terms the less have that intent In hazard still than correct,

you you trial the remind looking futility, to of ability when what you are looking is are benefit demonstrate you I'll your the the at doing of at drug. that, are

the looking drugs You at are benefit per se. not

actual communicated DMC after bar is is the is is obviously So our futility, that. What discussion not usually communicated publicly. with something that's the

have we trial designed of futility appropriately approval passed and need think We get to to the that that drug. the we benefits and demonstrate the sized is

So, futility the investigators the been that hear do what bar They that outcomes will passed, not know but DMC. is. has they obviously, will hear of

finally then question it the I And about was guess enrollment.

greater have not we yes, So, seen anywhere. or interest less interest,

not opened I regulatory open earlier Aron in as long whenever to was West more that patients same said higher they’re think geographic a have proportionally difference I nice very take they're various it rate. thought in trials of has moments. enrolled obviously to enrolling going really that’s we’ve on the but sites opened, for more bit those terms China at otherwise per countries. from just sites it you But there’s Aron, how site, and approximately said other cancer, East a gastric and

Operator

you. Thank

Sachs. comes line the Salveen Our from of Richter with next question Goldman

is now open. line Your

Maryana Breitman

which and had on what Salveen. make thinking combinations couple now, is will a taking about Maryana for is right like those looks I you for a but it This sense. on Thank hi. forward? will you also And questions. combinations going the indications? in monotherapy my Yes, Are be FTPXXX Breitman

Dr. Helen Collins

So is in BX-HX that, for CDXX-Fc okay. XXX is antibody, for the which

Maryana Breitman

Yes.

Aron Knickerbocker

XXX.

Maryana Breitman

Yes.

Dr. Helen Collins

agent. a that Right, on preclinical to single now here was suggest certainly, therapeutic so data preclinical year a we we in represented data than to with of really combination that action. there’s mechanism this it’s may a the said So, important ACR better last as that show suggest and excellent we particular we’re think there single XXX, the combination concentrating and work window as agent

certainly idea of in we're keeping So, the mind. combination

Maryana Breitman

thinking you like basket just for but have any do you you the to are mean, it’s or but see a like right So, I data? the idea now, with trial, want indications what

Dr. Helen Collins

we then the time a much some we this because this. not I of well response you obviously, we’re CTLA alone for have so that the the hoping thought do see directly have made will has some we mechanism action inhibiting I agonist at to what I -- in what the depend as same is what of those feel we’re obviously doing dose example as stimulating lots we’re the mean mechanism escalation T-cell conversations to had mean But it public. about but there, T-cell. about that broader do do We've extent, as we to think tumor see.

Maryana Breitman

is And What wondering. on they just see bringing would about the I was more so…? that I that? the why do Got new I it still bringing and indications program. give expanded We on. got dialog that it keep can they keep It commentary have them some and another cabira wanted if like you like indications mean just you one ship to, what on looks they

Dr. Helen Collins

putting now BMS is trials Yes our broad drug they is number so… winding that I really work team indications and looking that of the that to together that the of say is again amount doing towards by efforts contrary than BMS developing I the pleased they’re we’re other down not clear their think can’t the unfortunately the resources that it’s than but at more some

Maryana Breitman

taking and for Thank question. the thanks all you

Operator

Thank you.

the comes line question Joseph Eric next Our JP of Morgan. from of

is Your line open. now

Eric Joseph

Thanks for taking the questions.

endpoint high to where on guess, rates. survival line prognostic secondary it's guess, objective the PFS any the the there Just Is opportunity that that the to primary endpoints FGFRXb indicator. would the and we response a of target some for futility analysis implications get obvious at or based I of expressers is of with look try the as or for and differently proportion reason think to And I therapeutic Right of as on clarify overall strictly given secondary, by a surprising therapy? FGFRXb that function could

Dr. Helen Collins

easy the is Yes, so one. I think question second the

divide, therapy. to that of think by to they're stimulate So then factor the line cell blocking that's ADCC be of mechanism therapy. factors of growth no, no that would and be growth the the of going clear line and regardless mean, I it absolutely reason to second so there's that

our as of DMC. proposal said, we with the that have that a we terms futility, talking In will again, about be we're

specifically be be said haven't endpoints will a what we whether So composite. it will what using will or

Eric Joseph

the not the in question data to will just seeing strategy you're clarification advanced that the it on decision Is at and Keytruda? relates as was a be point And go-no-go just program this it expectation FPAXXX. combination to that monotherapy really be going with will based

Dr. Helen Collins

that asked you glad question. really I'm So

case. not absolutely that's So the

were much investigators just we represented how really was. happened easy the find these that to was safe again, patients, was us, the I at because think data is excited enthusiastic how what were we how felt ASCO, to how what the drug

we're XX would the Our who have is goal now milligrams per those dose sense and said, dose things an efficacy. kilogram, of of again early approximate, at the some some XX as that at patients full going same of ESMO to early you

is successful that allows are And benefit projected ubiquitous agent temper been where very we to rate, it's homogeneity, also expect to going like that, we activity, really of of see the because nature alone use based preclinical single expression, greatest that developing has where or lack likely mechanism see we our might of Now, therapy. we where I not some you over move combination. expectations drugs. and but of these and think this very it's of response XX% expect It you're line to have expect why lack the up expression not toxicity, drugs that you our a is that's do their cells, do we to are on on Herceptin BX-HX in it's end analogies those something what roxane we'll trying in something normal drugs that action the earlier of data

single what out So, response. thinking we're there see going sure something think should a XX% agent to go I we be now, make do to it's expect some just is to don't trying

Aron Knickerbocker

consistent about I'm this trying point. stay Yes, to

talked we're Herceptin single activity, that's see do ultimate the agent we clinic, want to about the single use setup with As analogous chemotherapy, agent, and here. a not as went be think will we which me combined an this again is they we since into program demanding that does it

are and will saying more maximization that tomorrow likely that think we no we we in also activity, of patients therapy be not So saying benefit combination. are

Eric Joseph

stage I are just ESMO for think follow-up talk guess bit that of here more well? histology maybe of Can just the sort about duration a of those you of here. as about distribution in XX occurring ovarian sort rest you and how the endometrial, of Thanks. setting and patients across to across different cohorts

Dr. Helen Collins

we we saying XX one patients about data had that have as think, I Well, are on scan. have who

So again to be scan. going handful it's to been enough early, and second and long right, have

you ovarian can the and well, common little breast In than distribution, endometrial. imagine terms more of

So, a it's their the endometrial, not those bit than between difference arms. more a of huge it's different but

Operator

you. [Operator of comes from question Fargo. Instructions] the Wells Our Thank Birchenough line next Jim with

Your is now open. line

Nick Abbott

it's calling for our afternoon, Jim. Nick And Good you taking for questions. thank

positive on both secondarily, but follow-up. Just double the why to theory futility not of And since you've positive on made And positive the double now and look this the then this And occurring have IHC-positive front for have literatures allow I going the the what's this is you. the the where line targets? discovery the Thank for and to a single in then back does your of patients? you patients? instances these patients, bema occurred trial, chemotherapy-treated analysis patients, has screened

Dr. Helen Collins

that's have some So, FGFRXb are that do and have out inhibitors company to in different. the the has with There over there then for drugs recall I that assay, to think first drug to you oral expression. FGFRXb is that but a tyrosine geared we're question kinase mutation, in and completely first ways, it really,

with of with of looking to is, literature at first Ventana work one come I/O a to difficulties essay. the So, with we're the people high quality

on literature, find assay lower, because over to XX% you've not is and depending X% variations XX%, through probably you you'll very up gone a expression is think essay XX% there say, XX% what probably those from to good. would if I to So, the

our see what if XX% around. hut was you even there, that into out might falling So, you

of In to second which terms with your do the has futility. question

because we a which the DMC again in do a is, trying is what protocol positive, futility again, do not something -- both. don't will why to positive really have make or is choosing patients that to have sure to about that right, is they're IHC the designed whether to are appropriately. pre-specify information are again ctDNA So Certainly, we you the it's trials

them we're again, to But, look we ask going at haven't disclosed to how that.

of trial would that designed be inclusion purpose IHC, goal now. but either being or that So, right reminded, trials the because again yes, ctDNA I'm but our for is the criteria this how one the still

size. whether of want the in the trial some you to but outcome be could So, or the speak not futility to in design or change

Nick Abbott

Yes, yes.

Aron Knickerbocker

versus a survival then And we've not on application. can X study plus the from predicted of earlier again question, chemo. into Herceptin gene the placebo that ToGA from going your literature to trial benefit it over Herceptin dug you expression for There was findings data, the that back is which chemo Phase see

for So, lower instance, see ratio I if their were amplified. there gene so there in of there that seen were was benefits, one patients even no benefit expressers, no hazard

cells. as cases gene target case the on not and and makes NK works the block X.XX. that’s patients copies factors can think shouldn’t surface there, FISH, in matter who as hazard and we growth a the relevant by cell much whether growth were the or they that cells. a in analog whether prevent for was sense It NK significant an long the this or ratio and Again, multiple status amplified signaling in was so case there X ICX is of But factors lot antibody in is and in were the there the you of a benefit

instructive ToGA trial. FIGHT what be the Herceptin that germane to and well. seems with trial as happened We that and So for the think

Nick Abbott

expect and those that in the to those ESMO, positive this Thanks that at we escalation And doses then It’s patient in XX that Aron. of involved very coming acknowledge testing from different bio-marked the these are moving fully patients we are expansion see really patients you to hepful. ASCO? at data that up FPAXXX, enough the dose characteristics the I blow milligrams be they from that different should are and patients

Dr. Helen Collins

and dose. see to the level a are that patients a only in to we of going positive. I for again something proportion positive BX-HX main right, See dose ASCO that mean had, were be is and were portion who we a a difference that had couple expected the might negative BX-HX

So stable I those progressive patients, thing believe so scan, obviously think disease onto But right? disease how do to again to XX. when the larger they to stable stable think And onto early Is disease? who number a there’s going way to disease patients way be it be, too it'll I going the PR patients to those one the or going early, right? for be be have a judge of is hardest you

Nick Abbott

Okay, thing, by getting some of one how but least but just disease that stable low. that benefits at

Aron Knickerbocker

Right.

Dr. Helen Collins

Yes.

Nick Abbott

you want patients me can remind then these And it design? in employing of Simon whether And you you're roughly, cohorts? enroll many how two-stage a each to of

Dr. Helen Collins

design, so and Yes, to is how Simon -- two-stage cohorts we XX the right have are a up now. written

Nick Abbott

you had target, this me that was at And start XXX, I'm for one the nature dose. very then assuming dose on a of given much out last mean, below that therapeutic the to

question at When another of planned? maybe seeing You're to doses now. six that ask dose get pharmacodynamics have a needed you see level where to is. How is the similar do preclinical what way you to you're levels the you’ve Or dose in many level to a models?

Dr. Helen Collins

you agency that have determines clinic, a have right. obviously, with because you is I you to extent that to have to And where start. some discussion into Yes, go that big mean, the regulatory

am I public. realized haven't I at and -- avoiding that So we because question your made

we're maybe we're get getting little you close, a but yes, So, know, there while, we close, in there, we'll maybe

Operator

would closing This for Thank Knickerbocker Aron turn today’s now to concludes I call session. to question-and-answer the back like remarks. you.

Aron Knickerbocker

Thanks.

are. and of FPTXXX. safety the trial; on are advantaging two, restate bemarituzumab finding for track, As I just the those near and priorities, One, to FPAXXX our call, at dose the Fight clinical beginning promising the all said and then of most three, opportunities; programs the term

fiscal data I mentioned, FIGHT also on with from FPAXXX the analysis, ongoing committed as the And beyond. to got exercising and tight FPTXXX and we're to act We've futility decisions making and data discipline. resources study, trial the driven

Prime who I'd to contributed thank also strategic of you investigators to like participated that, joining thank very in employees today. our with continued all I'd and the programs. you Thank for the advance who and to clinical us So like our trials, number our patients Five collaborator all much. the

Operator

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

Everyone disconnect. all a day. may have great You

Five Prime Therapeutics (FPRX) 9 Aug 192019 Q2 Earnings call transcript