FPRX - Earnings call transcript Q1 2020 | Five Prime Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Five Prime Therapeutics Webcast Conference Call. At this time all participant lines are in a listen-only mode. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions].

I'd now like to introduce your host for today's conference call, Martin Forrest, Vice President, Investor Relations and Corporate Communications.

begin. may You

Martin Forrest

can and joining Michelle, first everyone, thank today and XXXX website. our Thank The good press for and earlier issued us. results company's found release you on financial company you, was afternoon, be for quarter the

Collins, are Chief Helen Financial Medical me Officer. Officer; today and Executive David Civik, Tom Joining Officer; President and our Chief Dr. Chief our Smith,

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

change. Our assumptions expectations could and

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

I'd turn now like to call over Tom. to the

Thomas Civik

and review milestones. achievements joining good weeks Thanks, for you future. us look thanks ago, and excited and very today I'm previews to today Five and interacting call in have I and to afternoon, Prime Martin, on with to joined the X quarter first from everyone, forward our the upcoming

today, how remarks the my pandemic Five discuss and In virus it's corona I'll Prime. affected

also our trial providing to decision and update will advance Helen updates a strategic program an Our II on clinical financials. the is be and program. Phase David and provide FIGHT our study randomized on XXX the

possible. and needed Prime teams week that shelter-in-place working benefits early Prime the make action weeks. for we're the that of how for the organization the team as we a our team a our have as what with start pandemic. comfortable note leadership safe, by been many mandate. about likely as and this I transition they be team were important result, Five And me the productive remotely will to Five program. It's a at long-term sure to Five started This to entire Let our before When joined had already addressing Prime, couple able had

challenges This of pandemic. from Five to to families programs, of agility of bema the an the our great our all not proud concern with of that the have is many continue who the expect resolve for their Prime immensely X communities. employees, our of the the impact to coronavirus pandemic and and we I'm XXX. I'm well-being Because work an to coronavirus and report and do pleased on team, have respond and our lead team illustration safety who our

are monitoring will to changes. imagine, XXX. if might with the working Since spent amount situation of lot Five reviewing update was partners you programs. time with bema team Prime the with And the pandemic, We as a our closely I've significant of our plan, provide company, we time joining spent a our and an and

with it gastric cancer start There's metastatic I'll almost cancer in approval decade a need globally. fifth significant a death unmet gastric And the bema. first-line was cause of is last cancer So unfortunately, the ago. leading in as

to Prime team, our was decision and Five best with partners, potential groups the therapies options clear trial the After are for advancing committed a remain at advisers turn we bema trial. FIGHT also reengage very program Phase Five and and us potential to pivotal to with This decision might smaller generate have a discussing that will the became a partners it address study the II limited. PFS so And potential or to into us II our scientific the the Prime importantly, endpoint. that to main very therapies If like has where patient it design more primary Phase will the Most sooner, data allow sooner. positive, us allow data partner as are efficient benefit. following it this allow the bema to

positive, more comments will close In resources the decision allow Five us are by this saying that thrilled but I to other best team our to let on will Helen new interest to to an bema reallocate me not provide quickly. my as was and our the come decision this more make employees together the and Prime, for data programs event shareholders. detail in patients, see our member a that's important on shortly,

Now of trial This track noting encouraged by we We're in are with monotherapy also our to we in XXX. pembro on also program worth the on to move remains end data at on that initiate are XXXX. to and let results to closing generate me seeing. QX. planning be It's dose combo continue the a

Guiding the assets and how key near-term this and there priorities readout our with others. the decision the company team for are of to through I'm but us, also Prime. the our plan preclinical Five XXX data executive vision for working development for the long-term are bema influences

research late-stage this bring to X later and into programs development preclinical We year. are X expect novel advancing

have with continue Seattle like Genetics, we development programs will our Squibb look acquire and leverage And We Zai. expertise. partnerships established Bristol-Myers that clinical strong to companies to

I'd resources a Before Prime us important Ringo, last in programs the to guided Bill months. the and over to Prime company who allows team to to I it He in turn necessary these way Five over the through executive and X our invest some that times Five the Helen like team. and David, have challenging thank restructured

every my X over with me had the Prime opportunity of I've In And first one the comment meet a I've weeks, to conversations left Let each close Prime employee. about video team. Five Five convinced. these

to with our in patients before never possible. to mission, of ways place cancer in improve on team the which is have We lives the deliver

the call on details clinical who over Helen, provide more our turn programs. to now will I'll

Helen Collins

Thank you, right. Tom. All

on study randomized, evaluation double-blind, than our update patients overexpress FIGHT bemarituzumab, XXX monoclonal that with antibody. an a with begin more trial, under gastric is has Let's the Bema which enrolled cancer that FGFRXb. frontline tumors is FGFRXb in

the bema the to study. FIGHT to are to commitment trial patients, benefit of patients possible. may as randomized treatment to today, committed Phase gastric soon participating with available bema the both investigators and II decision study. provide realized made investigators in as about results FIGHT This convert who Tom remain highlighted, meaningful the and is we actionable strategic cancer and remain As when optimistic the announced a best the and patients are in We

patients rate to available the If program. expect Converting patients II bema trial end by allow early in positive, the for us to structure will monitored smaller, the to treatment enrolled on to unchanged. a a Phase pivotal more detail of modified data efficient potential provide to of continue of to be the FOLFOXX the independent next XXXX. will the Phase a date, bema will steps in and analyze or study III be efficacy results trial. continue safety data DMC. to XXX there's and the also the either XXXX FIGHT more trial clear more by and All event remain The double-blind the is will the arms design we and in Based confidence receive the placebo and in enrolled a

be overall remains As trial, will is II continue typical to which key for become The for will a endpoint. the survival, PFS. endpoint Phase patients followed a primary

in advanced don't poorly have with late-line with or patients receive and a hasn't devastating appreciably this a life frontline opportunity so from the changed in therapies. less a disease the treatment U.S., expectancy cancer is do the cancer XX remains and stage decade. perspective, to patient Gastric months Many

patients, single Newly bema efficacy the drug diagnosed only We're the better in and the as combined patients to remains FGFRXb extremely of the agent. frontline and data with Prime need to profile Zai, in of employees China. desperately the contributions therapies, be Five our and and partner a investigators clinic the from appreciative targeted trial chemo safety this with

remain for will a both this the and and months bring the the to support therapies generating the to globally continued the the for this We committed in and help Five look for in The clarity at that staff forward enthusiasm gastric XXX bema investigators, screening bema, Prime. of of the over program readout with patients desire patients data to cancer. near-term new XX our data illustrates study

T first-in-class checkpoint our protein has now cell. two, fusion to CDXX-Fc directed directly T X and stimulate that the by CDXX, CTLA-X Turning complementary This at One, cells to of mechanisms FPTXXX. to activity. action inhibit is engaging

inhibitor is T-cell or like GITR, only T ipilimumab on X-XBB expressed cells a CTLA-X or OXXX agonists that that different activated. like ICOS, are than FPTXXX already are

CDXX, constitutively on One is T of expressed is FPTXXX which naive and memory for Cells. targets the both

So FPTXXX cells. has the T activate added potential of being naive able to

South and In by the of in Korea. trial where and at Phase data, so far being there has COVID dose-dependent we this been and Enrollment efficacy. for both is impacted enrolling the a proliferation Australia on effective I based T conducted patients trial, central think minimally potential now memory blood, in we're the doses is as we're cells seeing

make on So of the we us data a generate evaluation should of remain end single-agent by enable activity the to preliminary XXXX. that track to

enrollment FPTXXX third dose in patients lung in in combination cancer with non-small the We cell treated escalation also the expect to quarter. of and initiate PD-X pembrolizumab

full FPAXXX, in of that do pembrolizumab independently. data a cohort combination FPAXXX scientific cancer arms submit long-term and Ib to the We've Phase patients We combination to with a not on targeting of ovarian antibody the that Moving enrollment tumors overexpress completed monoclonal overexpresses Ib BX-HX. and with at both Phase follow-up of the of the the to future development plan set plan combination We from meeting. arm advance the monotherapy the BX-HX.

the immune checkpoint situation, receptor antibody II based an XXXX. no COVID-XX that BMS' may longer BMS-XXXXXX, to of we before BMS trial turning move the TIM-X, Finally, anticipate monitoring targeting Phase into this on

these saying commitment cancers. drugs now novel I'd forward incurable we investigators closing mechanisms protein work on in because now results patients, like and meaningful on Prime we're community. we over X data Five novel a an to exciting close David. with sharing CDXX-Fc to I'll to of to time discovering actionable right of the turn fight action these as to and the It's by The at bema, call and therapies: with and of look having

David Smith

issued financial Helen. the be press can that in found regarding we results Thanks, this our Details afternoon. release

equivalents Turning $XXX.X the million as quarterly securities of operating quarter December Cash, to exceeded was We a attributed XX, expenses decrease marketable million compared quarterly as $XXX.X our of XXXX. primarily to This sheet. that cash balance revenues. cash and to strong with position. operating quarterly XX, XXXX, March totaled finished

primarily collaboration These February increases with performance progress BMS. license XXXX related the or XX% to The collaboration million increase agreement by $X.X in license pursuant first the to license original under revenue $X.X Lab. and XXXX, BMS immuno-oncology research earned license our of XXXX. of million the Genetics from by of was Zai our offset quarter collaboration completion from quarter million the and partially obligation first the from and signed revenues for to our Seattle Collaboration increased were with for $X.X revenue collaboration with and

towards FPAXXX bema. directed $XX.X administrative companion decrease program the to expenses. for our diagnostics expenses million of and the studies, program, expenses services or of quarter related The of lower XX% first our development were clinical and decreases primarily for the our for $XX.X miscellaneous expenses -- and XXXX cabira offset our compensation of costs, bema to from relate and from XXXX lower the XXXX. research quarter first increased million was lower first development development directed quarter and Research towards quarter October lower by $XX.X related preclinical to million. by first XXXX allocated costs to expenses restructuring, These were $XX.X both General reduced and FPAXXX and decrease specialty services clinical resulting partially clinical lab decreased trial the related in million primarily manufacturing and XXXX

quarter first and quarter first Net net was $X.XX share for the the $X.XX a million diluted diluted and per loss per XXXX million of or for compared XXXX. basic $XX.X of to loss share basic of or $XX.X

cash cash, and in Looking ahead, million and we expect be $XX XXXX between and cash million million. net equivalents, securities to ending between $XX activities $XX XXXX with used marketable operating million full year $XX estimates

the turn call I'd like to back.

Thomas Civik

Tom here. Michelle, it's I think --

think can questions line open now. up we for the I

Operator

[Operator comes Leerink. from Our question Instructions] Chang first of SVB Jonathan

Your open. line is

David Ruch

Ruch on This Hi, our Thanks Jonathan. guys. for question. is David for taking

potential from discussions business more an going? just the development to you study around in First any that did them? one, could you provide on be bemarituzumab how might update I were partners get discussions II And a Phase attractive these indication guess,

Thomas Civik

once David, it's in question. before answering outline for questions. now. We're this the all guess Tom to I'm places thanks we right just I different here, start and going say

of the the best from going home to navigate to appropriate places. questions my So sort person working to we I'm triage as the remote do

your start, So let me with David, question.

we us of front that last of had one And program. So obviously, bema lightly. quarter's in decision may this that we you was that didn't the with earnings, time about a spent in the fair take talking options recall we bit

month had. a we about through as just many you'd team the partners. we talked to underway in the joined ago, And I team when so And potential expect, options well thinking different was that

the the to to at existed and we as advisers, II leveraged contemplated talk Five We we FIGHT moving decision that trial Phase expertise study. of this Prime a

So did many to we answer question, potential direct parties partners. to talk your and

we One the -- decision the is reason be want sooner. data of them reveal taken to this able main to we've

So program. allows can deeper And the something into better us bema next to we the dive do is to steps that for that it that. this clearly determine

maybe ask me like a to here. let the bit So if that we've to little Helen, decision she'd add made

Helen Collins

well, II Yes. you're People is mean right. answer data. I Tom. what I see so we like it The would is hear. think that, I you mean covered to Phase would short that

I mean how is to decision all way talked move I we good talked would certainly, think think And if precisely And as think that's more then possible. see be the the but that III and of about, we forward. can data, see then we wasn't faster is designed mean, we Phase make this -- trial I the things data as the I about, about that one component. so that was best -- the I it's that main a

don't shall So change long think really in we the but run, this we timelines, see.

David Ruch

it. second then I Got question. Thanks. And guess,

on are XXX all that of That talk of to that about be situation I readout could COVID Just, how already of expect of or on be in guess, you them other early the might would -- patients? give PFS color guess, that? all you current some population? of Given what see there can and an and would timing for read sort and most patients this OS I the impact terms Or the considerations great. enrolled,

Thomas Civik

Sure.

Let add I'll me again to -- then a let little David, start bit Helen it. and

to year is as is to data plan going to this this With the now events value now would end PFS mentioned, or OS right at trial. the meaningful be XXXX. endpoint. extraordinarily primary -- we're early our But clearly, able it's event-based So share of And program. you of be an have to the that determine

Helen, like end reveal now plan XXXX. to So to our data the or Maybe, is this early that? you'd right add anything of year is to there the more

Helen Collins

November No. think except you've that I we've in enrollment timing Japan. mean end got for paused right the I the at of

more so But Japan. X wanting why XXX. it's to November and that's is safety to been on So data median some we've about get that months, now, in But -- have PFS we than the FOLFOX. modified

bit to be exactly starting a and we're in in, are it when though events the come the So that's even primary why we important collecting is still, have PFS of being But that will is we'll terms vague data. OS.

II especially they power Phase -- XXX is I it OS is that. enough like be Hopefully, to trial -- readout won't And what all than a on we'd on clearly to we something patients. trial well. should have enough But Phase live XXX II think longer patient we

this So we feel decision. good about

David Ruch

you very the guys. it. Tom, Collin Thanks Thanks, meet phone. Got nice and to over helpful. That’s

Thomas Civik

Me David. Thanks, too.

Operator

comes from Etzer Guggenheim. Our Darout question next of

Your open. line is

Unidentified Analyst

on Paul for have taking the question. is X I for on This Thanks FPTXXX. Etzer.

mentioned can closing So you this also data us the expect a monotherapy kind on remind data might in of dose, of what update as we year? later you

of timing Can And on combination you. color the with then the design part of you and pembro Thank this for results of in initiation. study? QX provide possible the more secondly, FPTXXX for

Thomas Civik

Paul. got Thanks, experience program our Yes. quite obviously, we're Helen about. Sure. then that I'll XXX excited has more with much and start

dosing that is has a you potential really So important window. know, a this therapy as

encouraged what different making the got seeing. And place. this we've so we're and at find we've doses by point, that we we're tried we're right sure XX that And

then combo planning when in expect QX. she mentioned, start about that we're And Paul, can, let of if pembro with answer, to as you And ask trial to we the me see some to Helen would data? part the

Helen Collins

Yes.

backfill, we think exploratory, a the that trial where on we we're to specifically do as describe we're now level we terms dose escalation. a types previously the for then the have likely that that X-plus-X activity, tumor are doing, dose our answer give we escalation, that word, we'd patients And monotherapy some better in Paul, So we're more and me our of you've lack heard dose see a standard doing think want.

enroll be be because we end next year, be end saying we're will we where enroll reason at and few patients, the patients then months, wood, strategic be our and couple the go we and decisions on time looking the imagine will of to the about of can we The of need year to to a these that making these those scan And months as you lines we before date, will data again, is to knock get results. This will hasn't clear. affected the COVID then want next. over

promise of anything always We to we other. committed to externally, or saying our haven't at presenting a the something year again, end the how publicly don't communicate might in at general. way want data that we and But form we'll the one scientific be because committed we're

is of the toxicity. both have combo likely we also this terms a In efficacy, that think but could combination, will that synergy, be

dose to it this a so X-plus-X will So a start we dose mean at escalation. need be does lower

the expect to we escalation move combination into XXXX. So in

it the combo heard that interrogate say lung safety. with want expect also conjunction cell But because non-small one into to to that limited be doses to to again, you yes, in As for call worth go specifically the me on well cancer, data other is efficacy that do is -- able we that's thing we the probably as -- XXXX.

Unidentified Analyst

Thanks very it. Go much.

Operator

& Cowen Company. of from comes question Shibutani next Our Chris

is line open. Your

Unidentified Analyst

Chris a non-small cell the wanted little Hi, lung on on good question. I tonight. to for dig deeper evening. This is CJ

seen driving in inhibitor combination the the is look what the start data, clinical to there, that far, And post in easier to was But with or you've an when Just in maybe might kind the supporting mechanism missed I biomarkers of this data be to we data, preclinical so of that? of decision? see if that Is first terms the enrolling. perhaps setting. Obviously, decision what that was terms expansion? checkpoint place

Thomas Civik

CJ, and the PD think, of remains, Yes, would really in already a pursue. lot lung unmet this the an I combining product unfortunately, sense makes And a there's obviously, that would our it a of, thanks need. yes. inhibitor XXX cancer we value of for the ton that information really about be valuable potentially Yes, marketplace significant question. area a with

that's someone cancer excited like need for time, excited there the And quite still So to there, the that significant this that a going quarter been us me XXX. area for forward of we're in third lung plus pembro I'm that's start this an is working for with in program. of combination unmet focus moving remains some such that with

go little on probably bit lose deeper question, did can Helen, no? we you you? a CJ's Helen,

Helen Collins

through it's the phone. Sorry, difficult

it's CJ, or treatment FPTXXX at So presented suggest PD-LX. with some we data cause to our AACR, can will that regulation of preclinical up -- data lead and does

rationale a this. is scientific there behind So

to there's data The the stick you lung wanted this, population, I hit if when the PD-LX those think expect main with a PD-LX, into lot to treated reason what patient alone. retreat of think, you you're PD we cancer were PD-X with to or the going about patients is, I also on

at it's recognize are, really we make and in people you're that be generate data. or to able really that whenever to we the think decision combo world, I that understand us a data look and setting, able And the important external

like can if you And patient thought was a synergy So think obvious said, where tolerability a is homogeneous and just see the having important. we this Tom then I population place right? of -- I to lines disease, in think that's reason. it's forward a clear path combination, a a therapy much very in earlier X-prong that a of So through kind big

Unidentified Analyst

Great. Thanks.

Thomas Civik

CJ. Thanks,

Operator

comes from Tony question Capital. of next Roth Our Butler

line open. Your is

Tony Butler

thanks Yes, very much.

I'm then bema? So I'm trial, when that are get to labs all the you in how anything may to one, Zai could if state been they question want the made the also they II Phase just move with you out discuss first decision if FIGHT. I'll adjust of to I That's have if question interaction is X. what may they may, question and curious that curious

you Helen, on so if it's also activation get and -- cell, you you CDXX, get or you you. affect as XXX, -- if of naive T Tregs do well? do activated do -- you Thank whether

Thomas Civik

both should questions, you Helen, the probably question Zai and Lab XXX the question. I of those think both take

Helen Collins

probably So on I'll Lab. start with FIGHT, Zai the

the So both we they with and -- trial have getting the in worked team a side-by-side we've and them, have been going and team from great our have their and beginning. rolling, partners, terms up of

the involved been along different they've options. way discussions all in about So the

I honestly And of this very can say supportive they're decision.

with to reasons. like really data. so was would get difficulty understand they the think some they, there I that. And not I -- again, just think any like And us,

So on I think aligned that. we're all

know, terms have I hope In somewhat in markers. controversial. on XXX, the -- what that the is, it's PD are -- call our I and humans, we effect we think didn't I Tregs, in mentioned blood you right of now as specifically back I

now just tumor have we information are we samples, -- then have and we and about samples tissue our more that. getting back should So some our

now, So have with anything that. I to share you about right don't

Tony Butler

Thanks Helen. very much,

Operator

comes Fargo. [Operator from Instructions] question next Jim Birchenough of Our Wells

Your open. line is

Unidentified Analyst

the for Nick Tom, James on and welcome afternoon, It's team. to this

to FIGHT. first going back my is So question

now futility Phase trial? the make to postponed been has II canceled did Or that decision analysis So with or this happen? a a now

Thomas Civik

the to to you. articulated Hey, that deeply. or we've And meet decision a this with benefit really able Yes, early the at Phase convert Nick. we've to of is taken timelines I here are data end II look being the that study. the much think of data 'XX, to Nice at the trial significant more the FIGHT year

a to plan longer. -- we're any have pursuing is it's we That futility we -- do and not not something So not we're analysis. not, do

Unidentified Analyst

at is, level do hot single enrolling. dose XX? warm XXX, a Okay. these and but that going to dose obviously, whatever patients so you're escalation on be a to Thank that you. And it immunologically going Or you to starting Is dose? then are

Thomas Civik

Yes.

I that you Helen, can -- think think, don't question. I answer why

Helen Collins

so which way we're Nick, clear the as the additional X-plus-X we're escalate, cohort. doing trial Yes. a is dose patients if is we Yes.

we the So to the and certain therapeutic in this milligrams, because window. probably some that at you sure at window to in we the of an to of safety And number IO continue we finish want we can a a some each we reasons clear inform we our data. that in XXX And patients XXX want we'd also terms with say, we have want patients patients we do that like so... to to go up that at to do for drug, additional XXX, want next want go better of make longer-term really getting get and is will as get dose safety as dose that the next escalation We -- therapeutic well sense level that. steps you're data X get to the really

Unidentified Analyst

That's comments, said clear. to On mid-'XX. FPAXXX, going for Thank communicate you. And submitting today's be data publication. then one-time you the just we'll said on by you're you

presentation have not So you Or are and you data the for a data to going just meeting? do or release publication submit line to decided just at both? top

Thomas Civik

Helen?

Helen Collins

Yes.

-- with program. plan or heard So whether not were anymore, do that to I what what and to now, are the what that XXX committed think the was not we you're to forward continue taking we no was we there's And this right today right, alone. going that we state

We that on treatment. true. have You've still patients heard me are and still before, it's say

that's to we So benefit, scientific present there like data who are would getting in and that are the form. patients some a

Unidentified Analyst

you. Great. Thanks, Helen. Thank

Operator

no any to I'd further the are Civik closing to back call There like Tom turn remarks. questions. for over

Thomas Civik

All Prime focus like and close on I'd their for us call. right. Thanks, for thanking the and and the for by Five during times. agility challenging joining today Michelle, to thanks the questions these team all

pleased to As results II Phase on heard we're late the a FIGHT converted today, early study you to XXXX we've with report 'XX. or available trial

Our in monotherapy a expect year dose progressing programs XXX the on nicely. have to track. on are our research and before is end and of program data this We're closing

with the ways programs, resources allows possible. to of discipline us improve important these to never continue strive financial we the before in patients continued Our advance lives to and cancer

So stay thanks and today, for us safe. joining

Operator

Thank concludes Ladies conference you call. and gentlemen, participating. today's this for

may day. a great Everyone, disconnect. have You now

Five Prime Therapeutics (FPRX) 9 May 202020 Q1 Earnings call transcript