FPRX - Earnings call transcript Q1 2018 | Five Prime Therapeutics, Inc.

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Operator

Good day, ladies and gentlemen and welcome to the Five Prime Therapeutics first quarter 2018 earnings call.

As a reminder, this conference may be recorded. I would 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 first 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 Events The Presentations. found be under and section our website can of under the

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

could expectations and Our assumptions change.

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

Aron Knickerbocker

review good Thanks to us today Highlights first slide quarter for XXXX. joining and afternoon. appear Thanks on Heather our three.

UCB quarter, we compounds, and and to cabira advance IND that of our technologies equivalent that of wave to of engine not our collaborators for which as generating a of validated to parallel including we productivity assembled targets programs antibody which increase we pipeline fusion the an we our the continued platform antibody an inhibitor fully later entered a which the is checkpoint our our and and candidates. or cabiralizumab under well. valuable BMS comprehensive and known just and engine call that protein, this potential discovery. with in FPTXXX, an the TIM-X, implement other target speed have half as duration with strong stage vibrant with pipelines monoclonal of targeting in continues to capabilities, This This cell The and BX-HX fully multiple our yield integrated a limit suite our is therapeutics reflected In continues CDXX-Fc undisclosed I to of fibrosis is licensed in state-of-the-art disclose. partners clinical foreign will file yet for of in We of immune The testament human year second candidates. the magnitude be strategically expect This the to recently responses. to our our a bemarituzumab, bema. new the progress quarter, clinical target T development, our product IND the FPAXXX, engine engine. power antibody, for During IND we product fill is clinic to

of the I-O, extends I-O. beyond We breadth this far focus yet have to on chosen engine

used have targets and we disease disease, find respiratory fact, it to muscle diseases in more. In many fibrosis, contexts, including

that estimated in cells. in role of the in of pancreatic the Our suppression a incidence Prime. in second-line and million Five showed four, milestone and therapy antibody, data, was progressing Anti-PD-X Slide This that you cancer data in tumor I quarter. triggered encouraging efficacy play and Phase for line patients pancreatic pancreatic payment a May patients macrophages. paper first cancer are deep not responses appeared issue that demonstrated Based cancer. label open of with targeting patient microsatellite immuno-oncology a pancreatic fall, with for and reprograms in in CSF-XR-positive a Reports demonstrated X our the tumor pancreatic just pipeline, population. expanding. T the have macrophages vital in Cell by stage presented BMS initiated we maintenance BMS agents validated that markets. to simultaneously cancer. CSF-XR randomized microenvironment as stable tumor-associated Phase X or Last durable The $XX late macrophages shown slide our this in cabira, development while start trial late-line unprecedented which five These X is into will data of rationale reduces with MSS agents in further major on on shows

every we also we effects to we in non-lethal in in of are will from reducing such in weeks we disease, plan this side PVNS I-O, observed dosing with what pivotal four schedule Beyond changed trial cabira the disease announce diffuse joints. studying whether proceed of a benign our rare have in Phase PVNS, a X/X the causes we chronic, on year swelling data Because Based irritating eyelid the with as we a the tumors by while two to to cabira from weeks goal that ongoing XXXX. efficacy PVNS. trial already the see study, preserving itching, and end is this

XX,XXX As slide U.S., patients in us opportunity shown the to a about we significant of a Japan, EUX the in chronic on indication. PVNS six, and be for diffuse estimate prevalence

the X a will Bema, into with of currently discuss portion the Phase combination in gastric first-line to chemotherapy program. bema in Phase I We half in is Now second trial lead-in the of known plan Phase year. in cancer. safety FPAXXX, portion as our trial move the X also X/X the of FIGHT

about expected the of Lab our trial strategic collaboration speed component costs in is to we program China our come the and region. Greater This of to Our geographic enrollment. trial this collaboration up expect an from since patients Zai important reduce half with bema is in

revised U.S., with FGFRXb-positive expected We you refined have of estimates and gastric HIRX-positive on Also, could overexpression HIRX trial. in see cancer to and to recently assumptions China FIGHT our be and seven. tend exclusive Korea raising our on be excluding are and don't patients the and Herceptin the we slide to Europe, Japan, number the from mutually patients FGFRXb are in since compete expect we

X monotherapy began in trial tumors. Phase very We are a BX-HX FPAXXX, which first-in-class about antibody excited also our solid recently

demonstrated other targeted checkpoint first-in-class when showed this given which and vivo are to dose-dependent Given in were in complete activity in in FPAXXX blockade. a development, clinical with make PD-X Meeting we no the anti-tumor in combination AACR tumor models invited at oral there presentation pre-clinical elicited is monotherapy April. therapeutic an regressions for drugs pathway as We Annual

the the wave cover are FPAXXX, that cells microenvironment I of excited targets Five have will of Beyond in shortly. next about Bryan in these reprogram we the Prime. great tumor confidence and future

transitioning and remain adapt the balance to across Moreover, toward needs This allowing over optionality company multiple and stage expanding, our with levers advance strong and Our we finance a company available cash. us pipeline the the have late with we is programs of we us million to sheet $XXX pipeline. in to to our are development agile time. us to have provides

history, to business one this access discovery patient the and and support because objectives are These landscape our commercial are provide would to We constantly they have be populations of to a deal-making and In maximize primary U.S. valuable with product Consistent potential a generate that markets. strategic maintain development we scanning cash, broaden global alliance, opportunities deals development value. of for any shareholder history us presence. both development. and successful accelerate

Prime later also our in our to former ongoing. CFO. meantime, announced During our interim Belsky, I an Five call. Financial Marc like change. left In is Officer, Chief introduce the She search An will financials executive the Linda would the discuss executive to pursue quarter, another opportunity. Rubinstein, we

Helen over turn about more For the now, clinical call I talk programs. will to to our

Helen Collins

you Aron. Thank

on clinical to that the our pleased and we continue to We will ongoing slide antibody progress eight macrophages the our cabiralizumab, across receptor start CSF-X be with three studying programs. on oncology are in I with PVNS.

this shown pancreatic us PD-X on pancreatic the last this They with combination reduce are hard-to-treat BMS's CDX-positive backbone. patient for and physicians to are Based cancer potential doesn't treatment fall, we and responses reported a durable emphasize macrophages stable CSF-XR population. the and PD-X completely that cells. We are inhibition efficacy cabira's unexpected the on objective remove inhibitor systemic enthusiastic immunosuppressive inhibition haven't in data chemotherapy about tumor-associated re-polarize combining in Opdivo inhibitors PD-X T with that include the to microsatellite

response response pancreatic can newly chemotherapy durabilities of also we likely and you of time with data, enrolled are overall we of that cancer. benefit These tumor marker nine macrophages. than data to of enrolled of X.X% The were As in cells, Aron a goal just large XX% in Onivyde we reducing combination on-treatment need late-stage baseline slide confirmed objective the X promising greater the of patients and remains total CAXX-X, Responses and to more lasted are bring of in patients second-line later an tumor providing pancreatic plus not to responses unmet to the with the with X-FU response evaluable XX survival on an Opdivo rate mentioned, In cutoff. objective these biopsies cabira accompanied by undergoing five a the as months. Leucovorin of patients. enrolled rate indicating reducing data, reported additional patients and at XX In the which cancer all are combination. those more saw to cabira-Opdivo of see patients understanding in from and months declines patients comparison, from the only first nine for

active synergy Nonclinical second includes and in to with strong or arms for you a care We second-line an trial the combination. chemotherapy quickly patients trial chemotherapy and of the survival pancreatic randomized X also cabira-Opdivo There's arm responses overall first and in with we and design pancreatic a randomization added XX. either with has scheme trial design Their four it of antibodies demonstrates combined believe standard to study way like chemotherapy. includes this determine cancer trial XX late-stage these control cabira chemotherapy which has used standard CSF-XR Opdivo Given trial roughly rationale data and slide BMS see combining combination endpoint. and XXX path rate durable because Phase has are forward into the on as in standard cancer, alone. The the ideal arm design is line And tests PD-X a the approximately patients. per importantly, an combination scientific models. when alone, advanced for this can a are regimens a comparator

We which as such the T rationale cabira Aron with Cell was macrophages, with in This and evaluating suppression combinations renal high Reports an also Opdivo, supporting and several data in for and a tumors paper indicates melanoma. content tumors that the in recently play This particularly as cancers in from and immunogenic. that vital beyond reported additional anti-CDXX and have identified ongoing with in pancreatic makes depletes selected pharmacodynamics macrophages, for not research cells. PD-X for pancreatic, radiotherapy cells. maintained trials pancreatic BMS a reduced therapy. loosens the U.K. is maintenance low there's tumors underscored cancer rationale earlier, Phase such a lung, that targeting whose our and strong presentation from also poster had researchers patients and Meeting. macrophages inhibiting mentioned macrophage tumor with role do respond CSF-XR to T paper CSF-XR-positive X also among ASCO We recently at of genomic announced accepted that profiling featuring abstract discussion Their survival more a the that Annual and XXXX poster was cabira-Opdivo investigator-sponsored trial stroma

data As we an patients is presented abstract be the trial monotherapy two seen ongoing slide XX. as joints. can design demonstrated preliminary this the focused biomarker tumor in from of in is non-malignant dosing data X denotes, year, ASCO is The At being selected which also on PVNS, on efficacy Phase Cabira with X being every trial. this weeks. initial studied generated Phase trial last with that title a a

enrolling which patients as data additional discontinued are to such Some tolerability on less from trial patients measurements. patients swelling a we end schedule to no-go to of by this improvement expect extra our in XX the help eyelid on up to these frequent obtain additional itching, dosing inform we make decision due and test go/ functional treatment year. and outcome Data a so will pivotal

attention bemarituzumab, FPAXXX. known our also Let's to as now turn

and begin design called December X/X targets We trial achieve approval this placebo-controlled The the with trial overexpressing FGFXb trial bema lead-in FGFRXb past tumors X designed we and modified to plus initiated global of later this gold portion tumors is bema XX, FIGHT A primary Phase both tools The XX% will trial using GE standard We patients FOLFOXX biopsies. and without trial is we FGFRXb. targeted trial dosed patients XX. Phase slide to patient This the in clinical portion compare tissue trial. tests therapy of studying is the chemotherapy was in for enrollment patients, for a ADCC. activating registrational to the on is blood-based shown found gastric sites, can identify enhance or junction are year. noninvasive recently first overexpressing the stage a slide placebo progress in advanced expect It the on April, poster to evaluating Phase FOLFOXX cancer bema be the a a options. treatment bema Bema safety and frontline As a alternative in us and cancer. FIGHT help survival overall crossover design overexpress its designed timing and double-blind whose closed accepted endpoint. potential bladder these in plus and diagnostic bema to trial trial modified In of and rate feasibility state-of-the-art we the of patient abstract landscape at X ASCO. monotherapy the of the after trial presentation the through

to antibody, slide shown So FPAXXX, BX-HX as XX. first-in-class on on moving our

to It the breast, monotherapy is also are releases tumors of we is checkpoint developing that potential We treatment. BX-HX to open on from FPAXXX. overexpress designed T and Once ADCC. Because to X solid this most have endometrial and blockade assay who identify to we FPAXXX action. enhanced is patients have dose of therapy, targeted BX-HX. plan antibody multiple ovarian puts dose the Effector initiated is engineered a March mechanisms In cell IHC cohorts benefit whose might to trial have cancer. we escalation tumors, a bladder, expansion including enroll patients selected, an overexpressed the in BX-HX two Phase

about enthusiastic this inhibitor first-in-class cancer. hundreds therapies developing are despite there approved of breast, checkpoint BX-HX I-O ovarian no since and enrolling trials are drug and patients a investigators it's to-date, or in Our endometrial against I-O

XX. our design turn to over now the efforts. see can review I research trial slide You to call on will the Bryan

Bryan Irving

Five proteins identifying play ability slide Prime, the Helen. our in At targets success arises virtually roles to disease any signaling of in novel Thank I probe that thousands you fundamental XX. am on process. from our extracellular

produced alter Our in function screenings, disease service their we the cell determine the fashion, agnostic screens ways secreted nearly interrogate medically in can to desired and known relevant in which scientists benefit. models. an all of have underlying novel and in developed proteins proteins similar that and vivo have produce receptors vitro therapeutic In genetic to mechanism

also in technologies candidates noted Aron in that modulating Our unappreciated others or against these have immuno-oncology targets. And have screens identified regulating state-of-the-art previously to drug immune novel function cannot. targets which roles as ways generate earlier, we

of We about are excited programs. our next wave I-O

activate Our most mature preclinical cells mechanisms. program is FPTXXX, a first-in-class CDXX-Fc fusion through protein T engineered to multiple

T on And directly to CDXX CTLA-X slide CDXX. from antigen-presenting on in allowing importantly You CDXX-targeted competing interactions CDXX, to T FPTXXX, signaling in half a antibody. costimulatory which of immunity of agent activity for to is receptor in it to for on cell screens. suggests to the efficiently IND interaction only that activation. uses CDXX application to a of single-agent file in the cells will induce the XXX cell preclinical or second, vivo was the to are engage anti-PD-X when was tumor activity CDXX and cells activity, in can foreign differentiate human in costimulatory And CTLA-X observed I antibodies. highly potent synergistic costimulatory equivalent in potential endogenous engagement. dominant prevail we anti-tumor XXX XXX the regulates tumor activator enhance We thus models of XXX second costimulates year. strong this CDXX see its presence therapies. the an XXX, with XX. as the that this stimulates the of refer binding though from combined first super with has with think in efficacy done as our should the track vitro, T and agonism expressed soluble without receptor blocking anti-tumor it with vivo Work molecule primarily immunity but CDXX identified primary direct antigen block

IND and studying at to screenings are we for targets partners. pipeline various treatments remain of Beyond development. of We own robust both that we continue our future patients with fuel on as our we I-O XXX, to expand our the additional product development anticipate engine pursue preclinical that multiple stages our are and additional

turn the to will our call to I financials. Now over Linda review

Linda Rubinstein

XX, the $XX G&A year-over-year. quarter the an the FPAXXX to our of of on trial. trial earned expenses million for increase related the quarter. spending its was million for FIGHT last a BMS's was milestone including under January. The The securities X Bryan. million results over $XX.X $XXX in on quarter, March XXXX in our the compared million totaled full on of for XX, $XX.X with or financial flat the initiation Phase Phase XX. portion our cabira $X.XX the proceeds of equity $XX prior million issued loss Cash, be details balance cash afternoon and was per $XXX from share. collaboration is in which of of release XXXX, and was and on of the XXXX of initiation for million. $XX increase initiation revenue reflects and year's this bema December the you This net as R&D slides found expenses QX X increase program, the of diluted quarter, offering well $XX first million million Thank the XX totaled first including Phase Net This over primarily increased marketable to equivalents and revenue totaled can X ended XXXX. clinical press a R&D strong quarter agreement as over Collaboration cash the $XX license basic $XXX quarter expenses million trial. We sheet. our million in

than operating We cash, year estimate used and million I net Aron approximately with cash continue XXXX marketable to $XXX $XXX less ending to cash closing for remarks. equivalents in be now we million. ahead, turn call XXXX Looking activities the will back securities. expect full to in

Aron Knickerbocker

Linda. Thank you

heard we So throughout the quarter this the the and will we call, clinical year. rest of momentum during as programs throughout continue you this advanced our

XX. You can see slide our expected on milestones

toward late-stage clinical development FIGHT We moving being registrational the are trial. trial with first our

our multiple to Moreover, fund are pipelines engine addition, fill our financially and and are our IND company a well the company. and have In to capitalized. we continues levers collaborators' disciplined we

am I future Prime. So confident very the Five in of

questions, our I the that, our in the clinical before And the will for and investigators Prime employees Five we up call trials, strategic thank to collaborators. questions. Finally, open really to want patients our participating open up now I and with call

Operator

And our from first line Instructions]. from [Operator the Robyn comes Citi. question of Karnauskas

You may begin.

Greg Harrison

Greg on X Hi. is questions. Robyn. Harrison, to Phase on the taking PVNS. you I for acceptable a you complete for see X? move to the on Or certain to do decision the that the am in curious to absence What Thank you be need make need relative This to of a there see dose? Phase previous edema? is to rate could Do

Helen Collins

that So good That's I will take question. question. a

We haven't said specifically.

conversations think durability which going of indirectly course makes of which heard have design I efficacy, regulatory demonstrated probably action have think drug, to is a how X real be agencies say you to Phase the needs and the that us as we of question's that on clearly we of have based had about with its the to I we mechanism and related efficacy trial tolerability. think before, be this sense

that your would not bar haven't am again, trying we but be. question I talked about evade So specifically to what actually

Aron Knickerbocker

pivotal we to we will or go, If trial. would then initiate year making not by be a disclosure our for trial said, the plans the XXXX. and pivotal whether early end a a That program of in proceed that's we will the this of

Helen Collins

my just a because The really right. add the is one say have other patients will color again, of vague huge this, some is, in being I

are a not edema So the ones we people because toxicity they decide the that such require discontinue. is that, that edema is to

the making how but is And of edema to it better that So reverse. also know Is their PVNS? effects the enough, or the reversible, worse reversible? takes it's patients it's really long bad We than decision. it risk/benefit

Greg Harrison

That Okay. makes sense.

than the tolerability it So of side discontinuation on actual is the and based rather existence effects? more

Helen Collins

limb a I will it's again, and go durability out and yes say the of because, response. project on

durability but So response, know certainly stay a to going they while get can are to for to patients have we delay mean, indefinitely. drug. they can't on delay I

yes, discontinuation So rate. it's

Greg Harrison

Okay. Thank you.

Operator

the our of next line MacKay comes Capital. from And RBC Kennen from question

begin. You may

Justin Burns

the for possibly some this release, Hi. on provide enrollment In congratulations ongoing This plus only first biomarkers. it on based patients? off, of assessed on your you on tissue trial, why third is indications? Justin, to of the Can for Opdivo press a Kennen. there. only cabira are patients In to one-third color tumor completing looks Is regards like being

Helen Collins

we expansion that again, of combination trying enrollment that enrollments, that getting cancer designed may getting balance again, that is additional X And Phase So so that. does you between just the the then there's each data. and The are do initially biopsies expeditious in pancreatic was know all baseline will this required patients in about. Helen. and the arms. biopsies way tumor because to has answer as on-treatment slow really the I patients cohorts XX escalation was talking in dose done, sometimes patients trial the The as the

and way, have if at we think that So you have to baseline that we XXX biopsies. probably about are on-treatment going it that patients look

to going think we informative. very be that that's So

Justin Burns

color. Thank for the Great. you

Operator

comes Instinet. next the our question And from Christopher Nomura from line Marai of

may You begin.

Allen Cha

the for on FPAXXX. Allen is on a This Congrats got progress. I on couple have Chris. Cha, the all

the naïve the the screening move patients we of pretreated you single-agent X. just a rough seems testing and and you. interim in treatments get be prior specifically Phase will Thank testing fast be only activity And can plans third some estimate rough last, give that you us That's you else certain can proof patients forward? patients? First, like concept, whatever color of any it gets need give a Will and all. estimate? treatment to see for and to for to response second, in you on us that you type see we respect might data and when on And the range how can with to like

Helen Collins

goodness, the let data. start me so So with

again, is sign Obviously, to but primary want are, think Phase trials said is well, right. X I as do endpoints and safety. the primary that, the enthusiastic Having activity one least safety, because going to we of the a objective number see said as very approved during first-in-class because are PD-X. second both right about tumors be the prepared I at that for don't it's now, it's have investigators some this and notes, specifically, an

we So anticipate this do quickly. to enroll

publicly when terms get to going we even In of it's talking about be actually we though, will will second that the half probably data be sometime in XXXX, XXXX. of

what In most need patients to have responses Again move we of specifically that trials, about therapy. forward, tumors. to you said who X we available terms of level these haven't don't have Phase take

a Phase to So something? of that that I fairly low again if also And add to that, you study. usually. that's interest of Aron, know don't And responses means of are want course you typical X have

Aron Knickerbocker

Well, design the Yes. you in the probably slide. trial saw

think those year. again, endometrial, ovarian, selected be the getting And next early we we cohorts and will are breast. into bladder So

attract the the K in the IHC things. does turns ready also to the be an got It We open go. It kill But and so as cells cells it's dual data those of again, drug, target. off that they this be mechanism this given have in that target. cells. will drug would we inhibition two antibody T we so the to Effector seeing trial overexpress mechanisms acts label of for tumor single-agent this who test to overexpress patients or as looking activity study And an checkpoint an And the we ADCC-enhanced can emerge. find

like Phase to activity other activity drugs So for as single-agent seen see we clinic with X. our in those single-agent the we reasons, would in just have

early of and off So we a that. decisions look to signal establish make

Allen Cha

That very you. helpful. was it. Thank Got

Aron Knickerbocker

You are welcome.

Operator

[Operator of Instructions]. from line Wells from Fargo. comes the next And question our Jim Birchenough

You may begin.

Nick Abbott

Applications. the Nick, this Future What Support and starting It's very afternoon. should Modulations in I presentation? to expect provocative, Immune mean, off title. Clinical that title Jim in with for Maybe we ASCO abstract just is the Tumor afternoon. Good see

Aron Knickerbocker

published abstract the Yes. yet. Thanks, Nick. hasn't Well, unfortunately,

we that immune of all I we on-target PD say says on assessed of you of future front right biomarkers to abstract treatment, But modulation is in that the patients, got more. pre that, So what is published There of just evidence week a markers and are applications. June you. have been have supportive tumors. as we Helen is assume the can't profiles can clinical And stay is genomic in But poster are as tumor the tuned the providing these title you there tell of it noted. well have panel X. think But beyond shown and on both until and next those as then it

Nick Abbott

Sorry.

we the as just So should expect see the to pre data? on treatment well as

Aron Knickerbocker

Yes.

Nick Abbott

Okay.

Aron Knickerbocker

can't But point. at this is that what foreshadow

Nick Abbott

us explore settings, neoadjuvant, going get are Zai on the you for to to then example? when give will And other bema. Can think And regulatory you able update approval? given an or market size, they interested

Aron Knickerbocker

in Zai about China? You are Greater talking

Nick Abbott

Yes.

Aron Knickerbocker

Yes.

already China. the in CTA actually filed we So

later enrolling that begin about are approval, But --? are asking CFDA We as this anticipating Zai would for patients year. you

Nick Abbott

No.

would Just patients. expect to when to contribute we begin them

Aron Knickerbocker

year. target, is by year Yes. Later the the this of the end

Nick Abbott

example, opportunity study? to And a other window then do have neoadjuvant, they as such settings for explore like the opportunity

Aron Knickerbocker

does Zai are you in rights Greater China, noting. development Yes. as have

conduct joint a So do we their to in that. wanted do that such purview and work. yes, study development additional if do be could expeditiously efficiently to coordinate they have they can. We things would and committee as do But a as to

Nick Abbott

one. last the And

So on have yet FPA, you recently bladder cohort. just the you cohort, I terminated bladder bema a noticed

is the what here? difference So

Aron Knickerbocker

Yes.

XXX? You versus are about talking bema

Nick Abbott

Yes.

Aron Knickerbocker

opposed target target target the the BX-HX abundant for to think XXX, We more FGFRXb the Yes. in bladder. is as

key a just the for on our that's based literature. driver So and us, initial in IHC what's analysis

Nick Abbott

much. very you Thank

Aron Knickerbocker

welcome. are You

Operator

showing I questions no further this And am time. actually at you. Thank

Chief Knickerbocker, call to Aron Mr. So I remarks. back closing turn would like to the Officer, Executive for

Aron Knickerbocker

us Well, forward you you for and Prime support and of on calls. today Sure. future thank to we for joining Five updating all look your

Operator

participating today's you and all may for Ladies great This a Everyone, disconnect. gentlemen, conference. in program have the conclude thank and you does day.

Five Prime Therapeutics (FPRX) 12 May 182018 Q1 Earnings call transcript