FPRX - Earnings call transcript Q3 2018 | Five Prime Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Five Prime Therapeutics Third Quarter 2018 Earnings Call.

As a reminder, this conference may be recorded. I'd now like to introduce your host for today's conference, Heather Rowe, Senior Director, Investor Relations and Corporate Communications.

You may begin.

Heather Rowe

Good afternoon and thank you for joining us. welcome the our third to discuss call like for results quarter would everyone conference to to I XXXX. presentation. We afternoon issued this and this also posted a slides to press release accompany Investor slides Relations under The and Presentations. found be under Events section our Web can of site the

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

could Our change. and expectations assumptions

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

Aron Knickerbocker

afternoon XXXX. and quarter today review us to thanks joining for third Good Slide appear our on Highlights Heather. X. Thanks

on teams four. current status shown pipeline. executing extremely The Our which is well the of are across Slide

five differentiated ways. look own activity activity types are class, rarely meeting high value timelines, medically in of our candidates Five sponsor the in agent that candidates focus in only product pursuing example either beating our other or the relentless to drug first on on inhibitors. have Typically Prime in We tumor we All is our teams their meaningfully or important original of our We development a for efforts or are trials Checkpoint clinic are which with or integrated to sensitive single testament clear and collaborators. that our now developing our are for studies. class only in

bemarituzumab Phase safety or address In global quarter, microenvironment. my drug advanced of bema tumor partner of began with portion trial. Phase candidate. the candidates completed portion I our cell our the types the multiple review X drug the our of lead-in immuno-oncology with start FIGHT will and programs most Lab Our immune third X our in Zai trial the registration we

see market think We can this Slide our an opportunity. on global assumptions market You bema X. attractive represents

Next in or evaluating is is cabira BMS' forearm cabira, trial to a randomized and as patients X enroll. with pancreatic advanced without cabiralizumab OPDIVO clinical with cancer. trial line ongoing treatment chemotherapy and second continues This Phase

this new recent chemo case impact urgency to chemo cabira randomized X of versus Europe durable Phase especially We in doublet true several are shown the to alone. referred the and trial in the OPDIVO has by in regimen. we Up X to combination of treatment sponsored gemcitabine additional opportunity can disease already by an pancreatic in shows of a into trial have by and benefit a cabira and is of to to of receiving cancer isolate example models patients as investigator trial. of without patients sense in we line a continues treatment OPDIVO more an cabira GemCaN designed One In prolonged called as deep mentioned cabira and pivotal This to a that median that top or in We markets. open trial fourth pancreatic significant. the of OPDIVO trials Asia. or their would BMS who cabira a pancreatic even To opted know development partner patients the Phase that to this chemotherapy to pancreatic antibody provide pancreatic sites microsatellite of cancer. by are BMS stable trial cancer with an including their cancer options. earnings BMS expressing on new an United the Slide Ono with In to and They made incidence demanding were cancer. frontline is their can responses pancreatic around is cancer. point the for Asia, data new the provide evaluating such area think on example is and this cancer the States, and options. BMS. The when pleased for that chemotherapy hear cabira. the trial where line hope commercial is major words, in world gemcitabine We cabira also pancreatic X their estimated and demonstrate innovation BMS And any of opened of adding and setting most as and help cancer. that market the pancreatic and BMS' therapy alone Stand find the in is call advanced and compared advanced frontline trial sponsored randomized be which control combinations is cabira. generate Cancer support determine include OPDIVO UCSD maintenance supporting example could importantly whether And that patients supported synergistic trial line second in a has current screaming preclinical and for

supported anti-PD-X cabira cell sponsored combination melanoma BMS. lung prior with OPDIVO trials CDXX Apexigen therapy. with Yale is on and or trial who the and by or example carcinoma evaluating Apexigen PD-LX patients in Cancer This and progressed Another by the is cancer in antibody clinical Center renal

BXHX. first-in-class family and potential cabira, our I is FPAXXX, antibody PD-LX. checkpoint target molecules the of also tumor multiple FPAXXX programs Beyond indications. will bema as and targeting the is that have address start same with This to FPTXXX in which our

generating it's that lot cancers. gynecologic a types, not T-cells. behaves breast BXHX investigator including fact, today a types inhibits like that tumor pretty community are by it PD-LX strongly immunotherapy well In is BXHX multiple the as lot expressed and cell excitement multiple of in clinically in tumor served types and such because

FPAXXX we In October, tumors as to to fast dosing in to monotherapy stage initiated of Xa/Xb possible investigate as exploratory an generate BXHX. Phase our with are proof-of-concept in move development quickly. hopefully then cancer to patients over any whose is plan basket cohort clinical express moving and we Our and trial later

trial and that look and express initial need medical to protein shown is cells Slide T potential agent find through tumors patient for with our multiple on goal to then FPTXXX, focus single pathways. CDXX-Fc on high overall a and an engineered first-in-class constitute to activate unmet Our BXHX activity over with is fusion dose populations large as X.

in to and assess then have Australia. activity. in Phase trial we Similar FPAXXX, single X agent an FPTXXX opened We find looking dose enrollment clinical are the to potential

our fully-human BMS, targeting the that pleased collaboration first BMS-XXXXXX in with antibody antibody continues that known The poster be designated X/X number candidate limit SITC pXXX advance from immuno-oncology the TIM-X In conference at Phase research abstract candidate clinical the a is monoclonal will and receptor checkpoint a and we're duration is of magnitude this to TIM-X BMS' week. the presented trial. T TIM-X addition, later to responses. immune cell

our see advancing of mechanistically fast is We're pipeline can and candidates. moving momentum. building distinct with you As product our portfolio

We cells. or T microenvironment tumor cells, are killer beta in engaging systematically the natural cells, macrophages tumor cells

have first-in-class demonstrated have exciting as sheet We agents we with a already as debt. activity development. strong stage have And their programs in balance no new later early clinical that well

approximately compared year We approximately with have million. to cash end guidance estimate now investments of previous $XXX our year-end and million our $XXX increased and to the in expect

we Thanksgiving. I'm Five Interim senior welcome Executive and endeavors. her and here her Financial years yesterday, programs. to to David call and announced leadership as we thank will clinical her than CFO of been XX allowed to brings now over to and that, deliberate her financial and excellent biotechnology. work Prime the Helen in Vice His With for in with us It's David after review be thoughtful search future our wish of experience individual find As us to and and Chief financial our for the David delighted Smith thank wealth well wonderful Officer. President more her in serve work well. to industry to experience stakeholder CFO role. turn the Linda also our Having I'll I want as to as Five her right will permanent CFO. join Rubinstein Prime

Helen Collins

you, Thank Aron.

our we make across highlighted as programs. continue to Aron notable progress As clinical

most on randomized our with advanced FGFRXb tumors express program over completed enhanced that FGFRXb. safety in in our initiated the controlled Phase study. bemarituzumab, X antibody first ADCC In global and Slide lead-in trial, we X quarter, in our class enrollment for FIGHT X registration First third the the Phase

over will estimated approximately Bema XXX against with trial You is can tumors patients with FOLFOXX junction the design in the to tissue combination placebo express FGFRXb or meeting gastroesophageal our and week, a or are and trial. U.S. who this and XX% patients with eligible had FOLFOXX trial. using X. on evaluate enthusiasm FIGHT advanced tests patients that identify Slide trial gastric for are this bema IHC Last cancer. therapy have see and combination ctDNA of The targeted blood heard in the firsthand against enrolling we to investigator screen we

selected single as is failed investigators agents frontline agents demonstrated bema from know, have heard several because recently positive activity targeting the was which treatment antibody gastric an trastuzumab is frontline HER population. approved and cancer. a therapeutic the has setting. cancer you in analogous we is As globally gastric it But X patient to it of This those different the from for agent most

patients the a Lab the accepted in trial poster simple ability chemo track to being to has GI overall test in cancer with the Europe data to January. conference X of are appreciated limited trial. trials tissue Zai five combination at patients identify investigators gastric of where China lead-in Additionally down safety complete often blood we're or the which with Asia. North the featuring the America, in abstract enroll An is and screen a common for with In the presentation samples should collaborating been the shorten hard to size design ASCO conducted Phase the time

low Last associated our XX, cabiralizumab the patients tumor cancer with microsatellite We're with with XX. agents stable these macrophages. are exome tumors for These receptor biomarkers disease. cancer BMS' in of demonstrated the that not pancreatic mutations anti-PD-X presented predictive not data the of tumor cabira Moving other to burden. single demonstrated that in these patients on to we known durable data expected on to would shown words responses XX% inhibition OPDIVO antibody CSFX CSFXR us had late Slide shown combining as be agent on in recently efficacy More for based alone. PD-X Anti-PD-X unprecedented has to analysis respond immuno-oncology is pancreatic In sequencing on activity chemotherapy. approximately OPDIVO patients fall absence have line Slide whole agents in

Phase pulmonary trial patients XXX X trial Slide XX now cancer. promising pancreatic cabira this of their Taiwan. the into BMS' basis Canada, controlled the enrolling line data, a from shows second U.S., patients and They're development approximately Europe, of cancer of On and Japan, randomized pancreatic advanced design. Korea

additional treatment urgency mentioned their As this BMS momentum pancreatic cancer new in where reiterated sponsored high cabira with Cancer reinforced earnings and including is Aron and is example. recent to OPDIVO their Up options by study Stand use of unmet anti-CDXX, need there trials an initiation areas and such the tumors. to in as supported maintenance by in BMS and frontline as call, and trial multiple This trial Apexigen solid pancreatic the cancer find of cabira BMS

to BXHX antibody Moving is expressed in action signal antibodies cells This and XX. and cells surface by expressing mechanisms BXHX depicted frequently cancers by endometrial to our over marker tumors two through as from shown ovarian of is XX. blocking CDXX designed BXHX on of killing Slide Slide cell breast, the through enhancing BXHX a tumor on over ADCC. to an first-in-class target FPAXXX, inhibitory sending on

we an study Moving on XX, ongoing of patients. FPAXXX Xa the evaluate have escalation to to unselected Slide Phase safety dose

exploratory In trial trial, in we Xa potential a intend Phase BXHX. after based which escalation activity models, cohort to portion to XX up to patients. We we on expansion monotherapy FPAXXX initiate addition, of efficacious portion Phase the may this completing the our portion. of investigate an patients whose of tumors dose of level Xb plan dose basket last After be preclinical the express month over the clearing in these opened

hormone We to look disease cancer, a various Phase will cancer specific as triple endometrial negative whose forward positive at breast tumors medical cancer. receptor such test XXXX. cancer breast, FPAXXX and of cohorts ovarian patients presenting X in over in We data conference BXHX express

an you'll to molecule potential Bryan FPTXXX T preclinical excited this is when synergistic Xa/Xb and Xb where FPAXXX, expansion to anti-PD-X cohorts. are a the portion to Bryan was Slide activity efficacy detail shown We'll now in preclinical will we be for trial Once cohort on of you suggest exploratory future solid tumors at the trial we call is we anti-tumor solid Next strong specific a with that patients various for date. with to evaluate entering with therapy. exploratory review specific types XX, why review I over cancer activity FTTXXX they models monotherapy research more clinic. dose Phase the our efforts. the Australia the in in on chosen and turn monotherapy initiate models. and in the trial in In of has to just will also cell observed potent We plan a and have update at combined this will FPTXXX disease co-stimulator this with in design clinical at the novel Phase see preclinical the Phase will first enrollment patients tumors. patients include we the FPTXXX product soon. completed FPTXXX is escalation X to candidate which investigate the our Xa opened dose Similar efficacy plan will dose cohort,

Bryan Irving

we therapeutics. to new find have targets, unique address truly ultimately prime, competitive protein us gives Five types cell a platform and a develop advantage that new At

state-of-the-art therapeutics multiple generate to technologies monoclonal as as proteins. protein well fusion other antibodies have We as such

screening therapies proof-of-concept. into advance clinical to is discovered differentiated and secreted are we that proteins screen extracellular agent FPTXXX. we growth immune dependent is dynamic by those that immune to are expressed first-in-class in them These that aim XXX call immuno. platform and which us identify a we we rapidly library development discover proteins tumor to One approximately associated is and example screening such This immune our Our with by that the or cells cells domain individually mechanisms. by helping inhibit

Fc potent the fused CDXX. of This the to proteins an In things. single to domain of drug is we've does FPTXXX candidate PK agent properties. IgGX that optimize its extracellular tested One domain most CDXX and antibody two is the pharmacological

T First, natural needed it's for CDXX, T the key receptor receptor effective in receptor for cell binding or co-stimulatory partner the to of the activation cells. addition

the applying by sleep exogenous received. [ph] we with the can So CDXX T of cells drug degree co-stimulation our [login] modulate

we've efficacy T CTLAX than super as signaling behaves with CTLAX. CDXX. seen CDXX with don't a in from independent directly work from of that and accompanying second, And tremelimumab activation. preblock agonism therefore Importantly for We engagement lacks allowing majority single then FPTXXX see CDXX we and to of block FPTXXX with CTLAX that agent interacts that with prevail mice it tumor-bearing effective know its CDXX function FPTXXX we the preclinical targeted a we the CTLAX if cytokine release Ipilimumab in lacks cell competing such FPXXXX. antibody. retains with an because antibody as activity its and differently endogenous antibodies administer

that single is to or strong anti-PD-X. immunotherapies single include range Secondly model across refractory including of single in wide tumor anti-CTLAX FPTXXX preclinical models which demonstrated models BXXFXX the is agent notoriously a agent activity agent

could we than is immuno-oncology an different and this a to important anti-CTLAX represent treatment armamentarium. believe the addition So drug very

some see of XX. on Slide XX can and results You clinical our

programs our We with to at pipeline stages research. fuel are collaborators continue our that and in pipeline various additional

You XX, our in this and immuno-oncology effector cells, can macrophages. primary see T-RACs Slide human vitro screens on early T included

Linda T presenting of function novel activating screens the drug response. by review the the lead other potential call competitive, I the We cells agent targets demonstrate in to emerging cell effective potentials of emphasizing over financials. that dendritic biologics to differentiated impact to still cells. an now activity. that antigen excited and optimizing this drug are or single our to now our turn to space at antibodies adept The platform's the will library on studying targets I'm can most but identify anti-tumor Io have

Linda Rubinstein

equivalents the XX Further our September balance and last cash, financial afternoon We slides December Bryan. to XX million in XX can totaled securities details a cash marketable on and year. as you, on sheet regarding compared release QX this well strong results Thank $XXX found $XXX be This million XX. equity as proceeds ended that the issued million press with in third partners for the Collaboration in million quarter and of our from cash million January for $X.X operations. milestone upfront revenue which license was less was received $XX.X offering and million year. net $XXX collaboration from used in than payments quarter reflects we've in and increase of last net cash of $X.X

of $XX loss legal other miscellaneous million XXXX a million expenses the increase This by included G&A per payments of and expenses and expenses due in share. of diluted expenses clinical by slight consulting to programs. $X.X development Zai from trial was fibrosis We XXXX quarter personnel dosing patient $XX $X.XX basic of totaled Phase As cabira which in increased X% preclinical with by the triggered compared our the and million and increased China million in X BMS decreased collaboration costs. spending reflected employee million third recognized collaboration increase from we This mostly reduced our first totaled to with million was with FIGHT quarter in milestone the quarter on and Lab. and third R&D agreement of for over and the compensation Phase quarter quarter $X.X the advance offset XXXX. our X third recognized first UCB. be last year, the triggered from time. Zai will as expenses payment revenue license the a our less revenue under dosed the for patient is Lab million collaboration deferred a collaboration the programs or offset milestone in offset $X revenue CNS for patent, for to trial in R&D Net in and by XXXX the $XX.X increase $XX our from FIGHT

remarks. in be million. ending and today, covers registration shelf-registration good no a equivalents cash, we to will cash our full $XXX from filed activities and turn in net Form increase cash expect The XXXX now now marketable than new to to approximately $XXX at Aron used estimate $XXX a the XXXX draw continue is revising Also closing have of from statement back less our the we million. this stock. year step our approximately we an to and housekeeping guidance is guidance shelf common I SX. operating up statement on This call Five of Prime ahead, previous time. Looking we $XXX to for million plans of with sale the million securities

Aron Knickerbocker

Linda. Thanks

mentioned Bryan for our is Five is discovery novel cell of of soluble identify targets secreted we extracellular in differentiator or As the and proteins. biology to Prime thousands collection our key use platform this immuno-oncology. are surface Underlying proteins. These that of forms proteins platform

years, the Over protein assays screen in vivo these extracellular out in models. libraries to models developed we've cell-based and about sophisticated ways these high physical libraries built throughput and

robotics extensive agnostically our leverage assess These and often computing discoveries very big and our to identify power drive data, pipeline. screens Our which then the we targets. generate best

build the on of throughout rest and momentum next. this We year the into expect to

We people and programs tempo novel our the all on patients to in push to continue as have we talented need. of committed we medicines bring forward

our XX. Slide on can expected You milestones see

Five want questions, and to and now participating patients open collaborations. well-funded disciplined we the we collaborators. Five Prime. our up trials, potential clinical to in very including before will company are to multiple future the of Prime for the it finally, discussions. additional business We the levers our call I remain investigators questions. our development confident strategic and have open employees fund and strategic financially regularly in I the I engage And We for up thank in

Operator

question Co. Chris And Thank & Cowen our comes with Instructions] you. from [Operator first Shibutani

Your is now open. line

Unidentified Analyst

is are indications across may looks and out all the designs development going from CSFXR be trial progress for [indiscernible] that we're cabiralizumab a Yes. there's Chris all there's clinical of help of you on about the Can these pipeline. going on days. on lots Hi. curious taking It Thank antagonist you. like made the there? competition is the understand, us Shibutani. how thing and being other This One differentiated lot Thanks question. interest

Aron Knickerbocker

TJ. Thanks Yes.

to there some and With strategies that are combinations. we the Interleukin and TAMs out where thereby binds, mechanisms, between receptor. on called depend there possibilities the development And to lag selected receptor XX through which the turn cabira, end CSFX you've of on and it's -- epitaph CSFX are variables think proliferate we signaling the programs, antibody an to CSFX respect I an that is so off bound activate. known the two and signaling

those poster data So shown TAMs. a that year we've We at BMS. at of we successfully ASCO this our can deplete already colleagues with presented and some

a So cabira. molecule mechanistically in good we we think have

dose a schedule we that's we've effective a that feel clinically. Secondly, and found

now advanced every kilogram the X And two so per dose. being Phase in trials. that's X That's weeks milligrams

We're and there market. first are hopefully CSF-XR in very first both to We're of So randomized the get that We to leading as a being and be position inhibitors first profile other a program to antibodies Phase also course now cabira's into the X small to think molecules. attractive. chemotherapy. trial aiming is with combine

TAMs We to one infiltration those into that and things pancreatic others of environments being cancer we're that are also can in of two at our melanoma. renal, cabira important with micro see exploring long selected that's now And but course. Bristol the of And you X as think partners of tumor studies where types like Phase well. the with are we respect

are to then So with We've checkpoint as no and as inhibitor last from patients that we ongoing And dosing trial to in who tumor year have Helen Phase signal a X cabira. that's shown ongoing schedule. are have vivo. the terms in clinical stable low we are other programs in burden. and like led mutation activity already quite which and you mentioned as in confident well that particularly study efficacy microsatellite But in a a would as the of population expect patient the in setting announced mechanism

Helen Collins

drug. at of and QX some the think the course to QX of being tumor dosing QX is combination I And and the we're therapeutic much that and that. we do have see really it's I to showed responses types, confident spent important dosing I in really these in I important being too QX a to is had we don't about with therapies. again, that know of are mean all quite time the can mean so results some same And you we now. and you other I think own trial the terms add think disease looked reiterate that know ones just detail then, different know in responses of window unequivocal. and that this are not it's the our I Io shown as

So…

Aron Knickerbocker

And at the polarization level, in tolerant MX immunological active can CDX the more cells micro shift environment we a do type the so know TAMs attack. we see the MX We that an to what happen. cells -- see tolerant from microenvironment, the inflamed T microenvironment carry want we to we infiltrate change that's have it macrophages out tumor from a microenvironment to

combination. So environment with in been gene microenvironment, markers this the expression treated we who've micro positive know in coming the way that also a we're the changing patients pro-inflammatory up signals

did answer So stop. with But that question TJ? I will your that

Unidentified Analyst

you. queue. Yes. That's great. I in the hop will back Thank

Aron Knickerbocker

Thank you.

Operator

Thank our question Wells comes next you. And Jim Birchenough with Fargo. from

Your now open. line is

Nick Abbott

like afternoon. Good this that Nick exploratory ongoing, to little news I'd it's great the about started. maybe so bit Jim, cohorts a in has FPAXXX and It's that's talk afternoon. for

to are dose, patients efficacy is to really this initial in recommended what this get show exploratory X establish cohorts? obviously, XX or So you hoping some Phase a signal trying

Aron Knickerbocker

Nick. that. Thanks take Helen

Helen Collins

Yes.

number that's slide think and doing we is initially sorry continuing. what of escalation head, top I'm all and the you'll I that off did we're not see So dose remembering kind the the of

a DLT is common we dose. very ovarian, lower highly as that we're our stop because probably a we're who a what calling over -- Phase basket we if So gone those. we we're up et don't less if know, X it what if a also we're But about being express because some end know BXHX to at high And a that BXHX, know tolerability. a an or doing this will certainly we -- know there calling patient just hit there endometrial any breast than public and score. But other we're when calling we exploratory cetera. that about are taking did We will know you tumors it this dose get has we've how I basket recommended

allowing of we we're on like that that know one tumors about. patients these go So or with to

of this bit just And is Phase -- of going So little could some be final data will the exploratory, the recommended little what point be really doses. lower X -- our one of as dose to again, at of a trying of but same these a will bit at probably get these dose in biopsies able we're really sense some activity this than be get higher, of single to as it but and get just of get would good on a this a chance proof get hoping to some concept baseline be to earlier be. agent we to how otherwise is is

Nick Abbott

sort for of start Okay. an and are at look specific 'XX considering to stage design And these Simon early efficacy? then for to in the tumor X able Phase Xb, do you you be think they get XH cohorts might

Helen Collins

as to even these I on as being flexible think cabira we think be trials be. you our well, trial write ourselves we able can know pride we as to

in our are out I protocols that I'm so be it's first those being depending on to be -- the start a certainly written mean be will some would So we next on purpose reasonable our because and expectations. of and thoughts But vague. how if I half I I right. of How's that. be balance year. Xb disappointed are those are think quite didn't will all vague think of that

Aron Knickerbocker

levels. steps in are of We those final

of of this our of interests mentioned is progress X we gone I half making than at the be level dose of much antibody for to Phase that that faster reasonable are first we one it's think strong in a it's year. could great as given these having original patients. the in But, Xb as that I X, think we're into So BXHX trial I those, reflective timeline and expect

Nick Abbott

just then quick the on And maybe biology. a question

receptor the not calls? is So checkpoints do you counter known, with co-expression BXHX on what of other know immune about

Bryan Irving

Are say expression. PD-LX you to referring you maybe

Nick Abbott

that. like Things Yes. Exactly.

Bryan Irving

they're but what do a not by tumors it overlap. direct And it's where by intriguing a clearly There induced interferon. to is co-expressed. up still not seems is We trying PD-LX There's not figure prevalent. PD-LX gamma that. we is that think out subset that is that know We're regulated them, of co-express indications an Yes. be can one often to XXX

hoping be in that it these indications So maybe are unique will blockers. receptor served a PD-X dominant by we're

Nick Abbott

are version receptor. of the These soluble Sorry.

Bryan Irving

Yes.

shared thought But as exhibition optimal we purpose. or for levels I think high. fact it you It's be serum. infrequent levels there not to of has potential at enough that been and it's use it extreme in can't for using see that High reported marker dosing. the to Yes, not BXHX. able PD in a

Nick Abbott

Thank you. Okay.

Aron Knickerbocker

Just add and is cell want BXHX as even to tumor active so as Nick case ADCC into we cells anybody if other that expressing recruit cells. positive think PD-LX, checkpoints still monotherapy could such components, they tumor and attack the the or be we can to then

So two to ways with kind win of FPAXXX.

Nick Abbott

That's Okay. Thanks. very clear.

Aron Knickerbocker

are You welcome.

Operator

question comes Thank Jonathan you. with from our Chang And Partners. next Leerink

Your is line now open.

Jonathan Chang

Hi. taking questions. Thanks for my

study, progress see when more you in faster provide FPAXXX clinical data? granularity might First given question than in expected XXXX initial can being any made on the the you

Helen Collins

So, this is Helen.

dose. efficacious to out we're minimally I starting of think -- patients you enroll the heard,

that enrolled the the informative a BXHX. middle reasonable by hard that How think the year. fair the we of so will to should some patients data be think we'll And have data of have number in have Certainly it's of to tell? by the that end year, we

again I but these really from cohorts. of that's on think we been it get how of data So kind next couple I depends vague quickly know

Jonathan Chang

Thanks. Great.

Bristol talk about and need the highlight? you of view TIM-X to with published this with how do there abstracts Are meaningful on your question your competitive differentiation morning. that the TIM-X Second you positions. landscape view Can points partner

Aron Knickerbocker

Thanks with the at partners a preclinical at our so Yes. how will it interaction a is things of my the start with escalation selected exactly presenting and has particular partners dose clinical X/X program. well. course, our microenvironment. program I'll antibody We partner a OPDIVO up on may know colleagues we And, trial prevent combination monotherapy some and be a Phase what TIM-X in Bristol. Phase X don't study Bristol to as Jonathan. in binding have and We temporary and with to occurring know a are add, portion, then, about That it with poster the Cicero in their in tumor the behaves our antibody in now but part. TIM-X said

that that's partner. it comment will an as on this. well know So binding does Bryan think we important let we I

Bryan Irving

least Well, shown have there been three been have at interact with molecules TIM-X. that to

about I or one field still which or in the are which think functionally there's important relevant. ones debate

is Galectin is those know the is We each X of [indiscernible]. and of what the CEACAM-X other targets. One competitors other don't and

know that of posters, not I'm But important reporting. Some what we're reported on don't think targeting them so to with going we've TIM-X. targeting. dominant the I believe the say not we are interaction we're we

Jonathan Chang

FPTXXX, one of one the and also we may, if this Phase provide just for on I you. agonism super risk And Thank can strategy Great. for you last how color the about think should program? X more development

Aron Knickerbocker

studies. Yes. yes The comment that on we Bryan those of super agonism, risk assess can and pre-clinically

Bryan Irving

to that view people actually now the antibody. the that potential FDA superagonist the CDXX TeGenero the reveal cytokine assay with an modulars all wants of T-cell antibody, almost storm There's

if blood you its the plate you a this on quote presence. of from PVMCs take drug activity human can now and You reveal

So if from now in expected agonist the simulation, the it secretion our antibody, and TeGenero ours high we see we've the add cytokine reveals molecule to release enhancement FPTXXX quite with compared cytokine cells. doesn't. whereas But agonist done we assay T definitely antibody this TCR now

not to that do does it. know So assay in an know drug is agonism, that reveal we super this we enough sensitive our

Aron Knickerbocker

Phase X Then, strategy. the

Helen Collins

far at as a was course start checkpoint similar with And dose, as the low Yes. have of again XXX. We novel quickly a XXX. to X that moved to very with strategy, we very Phase

moved hopefully just XXX. as with quickly we So

XXX of this for be in to case, going that there is swath be potentially a to broader much tumors this think drug. I would sensitive

efficacy is safe CTLAX also should clearly something I as single really, and would the tumors think then what essentially dose the how is, escalation CTLAX to all aside are thinking lone. able it we really partially -- expect obviously such from this being by because with FTA better except for be we that that tumor an tumors than types this virtue that works really, cold drug we're agent those of or about you agonism demonstrate classic

benefit of the things a maybe may non-small those cetera those at cellular that's neck imagine have -- to at in drugs tumors have can head, where agent some like and that are mild kind cancer more of that moderate this significant et activity. lung you So a single look kind those we'd But exploratory cell that cohorts. our

Jonathan Chang

That's helpful. you. Thank

Operator

next Citi. our Robin from And Karnauskas you. Thank with question comes

is line open. now Your

Unidentified Analyst

Hi. This is on Nicole Robin. for

were remind also And its diagnostic the using differentiated forward, you how just the about will developing ctDNA for going tests you you can indication? be how IHC they're explain us patient? identify could you trial, this and and this For

Helen Collins

are somewhere all positive in -- I got first these sent I two patients. to have there newly they for FGFRXb should and tissue get two there they The around again so sample are questions diagnosed think long sent then patients -- so of identify tissue are and first diagnostics patients, either in two all, as the a sitting the way. as blood are and then well,

demonstrates tissue of So not or patients if stays But significant that's to complete amplification tests. about both although do expect up of We FGFRXb if IHC overlap with population. we these end blood be overlap how allowed of by in expect the the XX% the we enroll. patient would positive that

the the with being with PGDx. a So IHC Ventana and done ctDNA

Aron Knickerbocker

diagnostics, I -- think be about your is question whether those last would companion that right? is

Unidentified Analyst

Yes.

Aron Knickerbocker

Yes.

available of approval. test. bema yes. the have be and part being to commercially by they would commercially developed bema again So available is in is the it would That -- with for it's answer allow patient either these they're strategy our And selection conjunction

Helen Collins

positive just the be by have both one do People or other. not to

Unidentified Analyst

Thank you. Okay, great.

Aron Knickerbocker

Thank you.

Operator

question Jefferies. next our from Yang And you. comes with Eun Thank

now Your line is open.

Alex Heller

I for just Hi. Eun. Alex on had two This questions. is Heller

from be can going X can cancer data? any first is we the data expect be XXXX? Thanks. bema, preliminary efficacy X cabira, For or Phase in in And to And we that ASCO for XXXX? data the GI second data at will study pancreatic expect secondly solely then safety of half Phase or half

Aron Knickerbocker

thanks. Alex Okay.

Bristol-Myers cabira for So trial. going Squibb, is our the enrollment X It's partners understanding are well. Phase running our the

Others sites, number open. planned can we mentioned are so our opening. you Many As worldwide. thirty sites nine got clinicaltrials.gov, are see they've a are of

So trial enroll expect to quickly. this we

in alternatives. cancer cohorts of tremendous those available and cancer enrolled We the experience the unmet lack quickly just of pancreatic own also know need very pancreatic running because from in our

enrolled would happen think we by trial data reasonable be guide BMS. So presented. it's think next the all that up respect right would year be when the or to to That's bema GI But that presentation could can't then done But when we them. it And with get and that I'll to the they're ASCO make, Helen. doing quickly. we'll it things we turn the

Helen Collins

Yes.

course for were recall bema to that. X the So there fact you or that demonstrated toxicity dose not indeed the be if and Phase the through pivotal full you has any of as the we anticipating as safety overlapping will lead-in come may the of we

we report I positive. the overstate So nor X don't what But cancer we know patients, Phase that that that so. point big want Yes, a This did we being efficacy had be what that's gastric require the patients a I to we so amount. we have. that have many on of to they have part not that to will don't But trial that have. about to we want enroll have patients data make did huge that very the had have to didn't deal for did some FGFRX efficacy

Alex Heller

Okay. Perfect. Thank you.

Operator

Capital our MacKay with Markets. next Kennen Thank you. from RBC comes question And

Your line is now open.

Justin Burns

up was approach you. and the Justin was differs Thank I on trial? in I this diagnostic discuss used diagnostic from wondering IHC the Kennen. to how at you is the This all FIGHT IHC Hi. X if follow could on wanted trial. Phase the that

Helen Collins

thing evaluation XXX extensive forward X So trial with working actual too -- I LTD an patients developing the with CDX. and X Ventana IHC over think our done -- databank is an we screened moving say cancer simplest the we to for also of IHC that to did the of Phase large a samples. the we gastric and very Phase had We've and then patients

responses by when Phase X. use looked the as really we where determined we've So and we it's cut cutoff our that seeing our where where score at using to each weren't determine we and were those for off that was

Aron Knickerbocker

Yes.

their know is, lock-in to concordance work see of lot a use we they was did the on platform good assay that Ventana Phase used What in that we the IHC X. a So do with worldwide.

that in forward So IHC between expect the we X the rates levels the FIGHT and upon we expect discrepancies that and trial Phase and saw also point. at going we don't for commercialization huge what

Helen Collins

confident get terms see to for we feel cutoff Now, the so our to response. potential need very we what about in of

Aron Knickerbocker

about Did you have also a the question ctDNA?

Justin Burns

the IHC. just was It No.

Aron Knickerbocker

Okay. Thanks Justin.

Helen Collins

samples. at So we thousands looked of

Operator

from Eric Josephs you. comes JPMorgan. Thank question next And our with

is open. line now Your

Eric Joseph

Thanks guys. Hey, for taking question. the

take ongoing looks with X whether cabiralizumab, extends cancer are study. from for whether they're types or the beyond data other the there is pancreatic forward. Bristol's Just cancer pancreatic cancer. it increasing though Up focus the on I'm one with preclinical on optimism get communicating If just Stand is table the focus as curious primarily Thanks. or seeing cancer the in tumor going GemCaN are Phase pancreatic potentially on on to [indiscernible] what that your they're

Aron Knickerbocker

in and question Well, Eric. example. That's renal long Sure. mentioned the melanoma. study Thanks your I one

in would investigation out But tumor thing I other the support clinical say study, types. poster did point from pancreatic in not cancers. we're interested the to Bristol what that point yet and is other disclose the in other It's data ongoing this a work remain that will at ASCO, The additional at pancreatic but and position Bristol be other we not types. tumor in in additional public, conducted and

Eric Joseph

and tumors types? -- of as the street on kind be there plans a potential Is might pancreatic the for the you other when give able sense Thanks. of to update

Aron Knickerbocker

lot and certainly street the of to the to this with our at just We time can't guide we'll a given about -- BMS. subject obligations inform this at But confidential it. speak collaborative are able point to when our is in we partners

Eric Joseph

Great. Thanks for the taking questions.

Aron Knickerbocker

Eric. you, Thank

Operator

comes from question with Raymond Seedhouse next Steve our And you. James. Thank

is now line Your open.

Steve Seedhouse

Thank you.

infiltration So but with by cells, or tumor macrophages epithelial TAM associated least expression my understanding BXHX at it's correlate tumor. into might expressed also that Treg tumor on

does the on or get to different mean your cell I cartoon, tumor blocking curious So of for stage have those designing contributions that broader of even of autonomous the program are and inhibition. in help to your markers just whether of the types, it and clinical on in parse the how relates a really thoughts And looking data choosing sort relative sort or expression matter anything next complexity focus of you that's slides the macrophage ADCC the you you solid microenvironment. out mechanism some the checkpoint to as I'm trials? are of you in indications effects

Bryan Irving

the find better mechanisms. able But of learn mouse clinical the should have don't say can receptor, preclinical in we not can about two we the we convincing We need I a of position expression currently carefully the to published on been is tumors but more with I reports have think the our because the that we we think models of in of it see But to on This infiltrating consistent can if and the human see doing been said, BXHX that we we're analysis found we've couple haven't macrophages. looked macrophages. human very development. it.

on it RNA messenger see don't Now for but the protein you surface. can see sometimes we the

we doing cells little of still macrophages. confusing, the are it's tumor with the of a analysis intent at the directly So and but looking both tumors human

Steve Seedhouse

it. Appreciate Okay.

Bryan Irving

suppression. macrophages PD-LX, assume of blocking both to contribute that the the cells inhibition the it. or T and while of would we could tumor that We But and I PD-LX like methods modes by guess, relieve would -- just both both

Steve Seedhouse

have in and move in combinations? mentioned specific hurdle or if helpful. Phase efficacy That's in the if strategies chemo you'd or the ahead Okay. just depending based asked, I'm exploring certain combination be combination of on looking this has patients Xb possibility just Io you data been for with but apologies Xb specific either mechanisms already And -- on if mine on a to specific Phase data. you there's specific preclinical curious

Helen Collins

ideas work. done some preclinical and of lot we've have we Yes, a

whatever be at at -- least of things at to you you'd looking achieve that we're before whatever move definitely want would when consider arm a would in something doubling we a -- the want response study it be rate tumor single think to least we I that would that forward. see bar of

more anything though. said We details any that haven't on

Steve Seedhouse

traditional the it combos I Would Okay. be I more guess something obvious mean of novel the would Io some you'd Is that? candidates just checkpoint be, than inhibitors considering. be

Bryan Irving

the going FPAXXX. nicely Preclinically, we definitely [Technical that with see that Difficulty] PD-X BXHX,

cells an of you once So be things inhibits that tumor and the PD-X we response the expect would one kill to immune initiate that.

this rational at but looked in make for it's the combination So as have also other we microenvironment. may sense partner a modulators tumor

we're just it's the not looking one that So at.

Helen Collins

things you tissues, which again aren't. of the the to aren't the anticipating of of potentially a clinician, of subpopulation if on And cancer BXHX know negative at they triple it that to say other from much looking aren't view with maybe for does that approved, is tumors I be not which because mean particularly too as point these other where much any PD-Xs tumor allow that caveat. that But we in breast types appear PD-X. we're normal be -- the would way combined And toxicity more than I

but pathway other a even your there. the may it or so inhibitors faster be smile PARP if science with as things such chemotherapy. to And Bryan at looking combine I is

you. a need what it think of also be combination out but turns number how be. to And Thank clinical the Obviously, drug those the to then I needs science. always is. one

Steve Seedhouse

the question. Appreciate you. Thank Okay.

Aron Knickerbocker

Steve. Thanks

Operator

no closing questions like Executive turn I Aron to call would remarks. at [Operator showing Instructions] this I am further Chief Officer Knickerbocker, the to for time. over back

Aron Knickerbocker

we And updating thank to of Thank look like I'd your on for Prime. support calls. to joining Well, all you Okay. future us for and you. today you Five forward

Operator

you And good in thank day. program. you conference. This Everyone for your the concludes and now participation may today's Ladies have disconnect. gentlemen, a

Five Prime Therapeutics (FPRX) 6 Nov 182018 Q3 Earnings call transcript