FPRX - Earnings call transcript Q3 2019 | Five Prime Therapeutics, Inc.

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Operator

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

As a reminder, this conference call is being recorded.

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

You may begin.

Martin Forrest

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

Helen our today me interim Officer; Officer; Financial our are David Ringo, Officer. Collins, Joining Chairman Medical Chief Bill Chief and Executive Smith, Chief and Dr.

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

change. Our expectations could and assumptions

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

I’ll over the Bill. call now turn to

William Ringo

Martin. to today and number upcoming I’ve forward Thank call interacting with to joining and and review to I Since interact our afternoon today. had becoming the you, you for preview and quarter with investors interim our CEO, analysts achievements chance milestones. thanks us during look Good the of third a

XXXX. forward This multiple our wholly-controlled future pipeline look milestones has data of for make a and allow we readouts decisions been clinical programs us will to prioritize year many These in to data-driven readouts to disciplined investments.

mid-XXXX. data of track We anticipate enrolling are in we expecting arm in a first combination in planned for year. on of analysis data the half programs futility the early ahead remain several and FPAXXX readouts trial The from of We schedule from FIGHT efficacy XXXX. next is pembro

poster and at of from late have data FPTXXX expect SITC data FPTXXX the this initial in reporting clinical are Saturday, We trial Phase XXXX. additional in to coming safety presentation the X

BMS and our pancreatic in data have second-line has programs, and randomized cabira of Opdivo the year. Phase cancer partnered completed we to trial enrollment, actionable expect X For next

clinical X/X to with TIM-X a in Phase in being studied by now monoclonal BMS advance antibody a trial BMS-XXXXXX, fully-human that targeting finally, combination continues is And Opdivo.

priority first long-term to the of and goal Prime’s Since Five becoming ensuring our value operations creation a company. review was conduct sustainability my interim the with as a CEO, of

first cash as prioritize us enables programs, meaningfully and prudently advance to that pipeline. restructuring long-term implement a the My plan our our runway action strategies extends was clinical evaluating to to grow while CEO and

all well a the As impressed has have with agility by team part more people the become caliber professionalism the we and the engaged team organization. of as to of been nimbler I’ve as process, that the work in our and the as shown organization

mission Our passionate is team the is about well underway and planned. the restructuring as

take mine six new to of CEO. process to four search process priority a and committee search composed expect search formed members months. the a start recruit search Another to firm, the a Board engaged We’ve been of to has approximately

and inflection beyond I team, and is And the will look until in programs our the confident XXXX with to the our I I’m serve advance team our points continue interim search through appointed. forward events, clinical as to represent CEO a the progresses. company. while our for new working Prime Five ability which pipeline important data CEO to

now will on Helen? who Helen update our will call I clinical an over the provide turn programs. to

Helen Collins

Thank you, Bill.

trial. with and begin bema FIGHT Let’s the

trial. the stage for paused enrolled cancer, gastric diagnosed patients the have XXX We newly enrollment than approximately projected advanced pre-screening total and have of with representing more XX%

analysis planned patient based is global The in population track for approximately we in on FGFRXb a data this futility and of remain mid-XXXX. overexpression on our pre-screening prevalence XX%

to only the the futility. to an public maintain investigators committee. the passed the And expect data you trial for whether independent have not make I’d the in the like to or double team, remind monitoring of trial trial we has we FIGHT trial passed is which study means and the is placebo-controlled that a blind, announcement integrity that order

to on tumors month, of we ESMO BX-HX. that from the overexpress presented targeting last antibody preliminary expansion Xb trial. At our is the which Moving portion Phase monoclonal monotherapy FPAXXX, efficacy results

As endometrial and ovarian, therapy. for disease in patients were confirmed remained of date, XX X data stable additional evaluable there an cut-off patients ovarian One August cohort were the the who and breast response, across had had cohorts and a response. patient on XX

of of as potential or stable either responded the in cells observed in infiltration Supporting the we the NK T an had increase disease. tumors BX-HX patients cells and target, who

we FPAXXX pembrolizumab from combination with arm On also be first Xa XX three with suggest weeks in Phase with presented full standard safety dose full data the every combined milligrams dose poster, of that could which the FPAXXX per of pembrolizumab. the four a patients kilogram

preclinical first on the we anticipate our the FPAXXX efficacy hypothesized plus XXXX. combination. FPAXXX, data and the opportunity of mechanism of action early The data believe we to that is schedule half enrolling most Based is and ahead in expansion a FPAXXX continue of for of in pembro promising

FPTXXX, our escalation fusion according SITC novel present pharmacokinetic at and coming November Saturday, this safety first the will to available is escalation to Turning data proceeding cohorts protein, X. the and CDXX-Fc from we dose plan initial dose

data release hand Clinical other release other be and fusion on protein T superagonism should through CDXX-Fc syndrome. a that reported not activating therefore requires administrated activation and for cytokine is CDXX FPTXXX showing severe the superagonism. exhibiting drug syndrome of be T without cell antibodies will trigger encouraging have co-stimulation can this cytokine cells because

early have is completed X programs, BMS in but for it’s we actual this determine will disclose and data trial year, sponsor Phase the the and cabira has in For Opdivo second-line our and partner data recall BMS when Accordingly, program. randomized to steps of next pancreatic BMS cancer. next trial enrollment appropriate please expect to

TIM-X, receptor Phase X/X in And finally, with is antibody combination Opdivo. studied an being clinical to now by BMS-XXXXXX, a targeting in fully-human advance the trial continues checkpoint and immune BMS

into first of collaboration effort collaborative action to with Prime’s the BMS. The the utilizes the that research pH insights Before led productivity to and was immuno-oncology to tumors. highlight new by ending, in identified published of from BMS recently I’d like example The large journal mechanism VISTA, relating checkpoint the work of a function Nature selectively Five research providing the Prime. latest this discovery of result Five

turn will to I the call now over David.

David Smith

Thank you, before comments on to the third to some with want begin quarter restructuring I Helen. results. turning financial

upon decision our and we Our on we our the our readouts expected goal expect promising programs as to aligned restructure of in programs to cash XXXX. extend clinical with that runway is execute focusing on based data most is

for headcount to during the result We will expenses. quarter the approximately pre-tax of costs restructuring The expect to facilities XXXX. incur company million of severance in fourth related $XX primarily the of restructuring reduced from charges annualized and savings million X

into future. As be and be the by The rightsizing of the of part the that will have our pipeline XXXX. length data informed the of runway outlined cash investments the be organization, will future by events for will extended restructuring we further the determined of meaningfully runway prioritization cash

have FIGHT both partner As running we if FPAXXX upcoming cost make Bill in the and not trial. Helen may mono Phase decision enrollment the needed trial go, resume of bema passes the we mentioned, and go data given significant no without this global futility X for soon has a a combination the analysis, will to therapy. Also,

We decisions to resources have the more taking additional no FPAXXX will that or programs incur milestone. for is and take FIGHT FPTXXX. program potentially one just not here savings but could we the trial, beyond not us that could cost by clinical next the through by to the we decision forward takeaway realize key go The go, potentially or additional advance

the data at this in XXXX. of next know and will We wholly-owned for readout these three controlled programs each

results financial XX, compared equivalents as million the the to for securities totaled XXX.X June XX, on Cash, cash XXX XXXX and marketable turning Now of quarter. million XXXX. September to

XXXX expect XXXX. approximately in of the cost the beginning to activities and in used net We estimate from million marketable equivalents range XXX cash, XXXX cash million XXX to to continue operating ending to restructuring in full cash in savings securities. year XXX million XXX with million with We be

$X.XX was to XX.X last the for share. was attributed license loss million loss overall net basic third and revenue from quarter of million XX.X the million Collaboration diluted lower and expenses. X for or This and year’s was a per operating decrease The quarter. quarter

million quarter This the made related immuno-oncology of and was X.X the from research last decrease primarily performance under term of third agreement. in collaboration collaboration progress a research towards was under decrease completion the of obligation is from expected. This year’s the XXXX to revenue our and March BMS

compared XXXX. This of quarter expenses FIGHT development XX.X and primarily of were in in the due was third in milestone of by triggered a trial. decrease Research X XXXX third payment million of XX.X the the one-time that million patient quarter the was dosing third quarter first the the Phase for XXXX to

the to preclinical costs, clinical programs. diagnostic for manufacturing trial partially compensation decrease by were clinical activities, contributed and increased offset expense research and expenses our and Lower

XXXX. expenses was increase to to the a XX.X in X.X The primarily resources. compared by in of million temporary costs due use totaled decrease increased offset G&A million of compensation third the quarter

we our through go FIGHT which just In no extend us but and the cash will FPAXXX runway, take trial, QX balance sheet go, closing, strategic with restructuring meaningfully a FPTXXX. and our ended decisions not strong will beyond for

Q&A. the turn call back to Jimmy over now for I’ll

Operator

you. Instructions]. [Operator Thank

Our first question from Leerink. SVB Jonathan comes with Chang

now is line open. Your

David Ruch

of looks This Ruch a is I’ve David like questions. updates. guys. on my and got Congratulations and a here Jonathan. taking were Hi, for progress the for lot thanks on few there

and data schedule half there terms you could 'XX efficacy press release. that Thanks. First be patient was Could you enrollment just comment first on the half observed that the in in at 'XX, of an versus in and how progressing first of that that would expected I ahead population and much of on be mentioned point which update in ESMO? don’t know the FPAXXX, was

Helen Collins

clear that I first in is expect of This Hi. XXXX. get Collins. to want data the Sure. some Helen to half be we

not be course, follow updated publicly monotherapy the that And the said data on of would patients about more when importantly We on combination. will a data have up talk but what is. we longer-term

all what – those of are we patients ovarian BX-HX of we’re the efficacy and getting full cancers next expect we these dose patients right overexpress tumors with full half now of in year. from are dose pembrolizumab and the patients early and So enrolling whose first FPAXXX is

David Ruch

Would it be --? it. data Got mid-XXXX those in or expect XXXX, to be safe to presented

Helen Collins

Yes.

As Xst. are February somewhere around you ASCO usually abstracts know

but -- data. to So we’re yet, right these just because don’t haven’t I having any conversations have want commit those again now, about seen enrolled, patients we

David Ruch

Fair enough.

second logistics the color broadly, from you XXXX. I The looks It timing in sort thought give you me, transcript BMY data say the question XXXX? one heard like of early timeline Could regarding XXXX of cabiralizumab. says I any on another but

Helen Collins

controls This should I everything them. data, say the you. I’m BMS Thank to with is glad trial should run data release I clarify a and aligned and the BMS of review that. so of be

make sense. would misspoke. I be which is XXXX all So It should know, we

David Ruch

then Got guys of one this And timeline timing just regard study, it adjusted the of sort Is say you to we to else? question. as this 'XX. of refining take another like it. In first FIGHT been last looks timeline mid-XXXX sort or something the here should the refinement half has versus

Helen Collins

Yes.

– the said half. when going first in an said I first when think we do futility, earlier very earlier this to year said year were in we we XXXX early we

January. But of saying, as was a majority that get trial people will a to the on January. so think patients probably And first be little started the you enrolled being mid us to we of course really although now it’s for of now in so precise we enrolling later when getting right part on when so we’re about be us As the closer these thought September events have occur. people this we depend so to that aren’t going It’s event-driven events to over say the closer, point it just know, read expecting at the of November of XXX it’s the No. occur. a summer going of and and it’s questions better lot hey, XXXX, early to to half,

But another I her get to us we readout bit a give questions will the we and of closer months to able think says little great. would your statistician couple are hope timeline be when tell should Our be. and she

to internally, trying is data-based sure decisions I I we’re readouts which to to theme and our in portfolio. clear, that you’re trying again out here read we’re speaks data the make first least really the made all of it on something anticipating half next think we that at highlighting think make important year

David Ruch

comes Got and out it. for seeing XXXX. forward Thanks, what look clarifying I Helen, to of

William Ringo

So we. do

Helen Collins

Yes.

Operator

you. Thank

Cowen Our comes next with question Shibutani and Company. from Chris

Your line open. now is

CJ Zopf

Hi. Good CJ evening. on tonight. Chris is This Zopf for

wanted Just the on a questions to up few with FIGHT follow trial.

data of the your continue can you the the talk not un-blinded you the be partner. Is this that’s if that may Lab something to partnership? you that of analysis, was at Zai to successful, mentioned point without You trial outside partnership discussions? so a would futility And in

William Ringo

is This Bill.

can allows couple a take that it forward. there know, a saying to how decision not in. the shot us but join me of think be We’ll or we you that’s partnership. blinded to And would Helen, if Let would make data. when information of that forward then I plays on go to people anything majority add Helen a There at go and about a blinded see that? be people we’ll a basically get don’t And not want to out on

Helen Collins

perspective. Yes. Nothing’s our changed from

terms will a data. we haven’t the what have futility the independent that up, I publicly giving of down. look is, us all but They in will the thumbs sense an thumbs in we for They think bar that DMC. said be bar the at

there As people more you pass who step that. programs going of to be partnering first may you got is X as where on as anything in into other of where be the going, well. a than a know to go then then cancer, Bill course that the trial. in. our decision always want with this now will said, are happening with landscape just external I’m said, right change aware some that and would would But spend right, business and of there know, related terms we management what’s also to decision. is bema bema couple forward as move will that It’s to of this. the how futility Phase trial, But expensive be that externally gastric a not an with in fit will it’s so And we of resources other And

the part the this realize – then the going just whole again is there’s vague a sounds go, decision that I bit I it. isn’t no go to business think a but it’s So point but futility be from of

William Ringo

we Right. question? your Did answer

CJ Zopf

Yes.

I If decision? that futility think the made disclose is criteria readout the what that so. would successful, were you

Helen Collins

no It’s No. a no go; go, pass. a pass,

CJ Zopf

it. Got

you. Okay. Thank

Operator

Thank you.

Our next Steve Seedhouse comes James. Raymond from with question

now Your line is open.

Timur Ivannikov

Timur This on Ivannikov for Seedhouse. Hi. is Steve

question first cabira. regarding is Our

would you. there payments? decides what XXXX. actually not, are trigger any milestone assuming potential Bristol type you of data So actionable Phase payments in it take X mentioned needed? is X Phase And then milestone to coming into if if events that And Thank

David Smith

with We’ve would though. not There David. is This payment the size of what initiation the be of trial. Phase a milestone X disclosed milestone the that is

Timur Ivannikov

on Okay, got it. And then our next question is just to FPAXXX. clarify

combination you certain mentioned you cohort of the cohort. and would the about make no So the I looking you go to guess for? Is to thresholds go, see could your talk Phase decision? there need Xb types monotherapy responses you’re

Helen Collins

have a we internally yes, threshold. So

guess there’s the it isn’t of We various there the types. haven’t improved, couple a although way reported tumor I that that not XX%, made them makes I lot rate. XX% public. answer cancer think to single of most in as agents, The response inhibitors ovarian have are checkpoint a

we that. combination, for for be see is us to So we something want to than you that higher would significantly statistically that think a imagine in interested can pursuing that

Timur Ivannikov

Thank guess Okay, you. a question also got development. I clarification on it. FPTXXX And

So I of you’ve saturation some XX What you’re on? based proposing think milligrams. level that maximum in receptor that maximum Is preclinical based is found coverage studies? dose on that

Helen Collins

that abstract SITC? we you’re what on talking submitted think about based the I is So to

Timur Ivannikov

correct. Yes,

Helen Collins

Yes.

on to poster Saturday up. So after we’ll we and I’m going answer our punt say that have

Timur Ivannikov

question And pembro else? FPTXXX, Are just more like Okay, you any or one something planning I to do combinations got it. guess clarifying there. with

Helen Collins

if with does agent, and this that We’ve we combination. now, I-O better it it the any that you’d way to even a want activity, right make show for single is world expect which sense get also you discussions certainly with agent the drug had would Certainly. internal activity as even

but that right So lot protocol sitting the now is parking our not right in now. in

Timur Ivannikov

Okay, got very Thank you much. it.

Operator

you. Thank

question Richter Our Salveen next Goldman Sachs. comes from with

line Your open. is now

Ross Weinreb

Ross Hi. for Thanks on This taking is question. Salveen. the for

if do so communicated past still here, of trial to it ratio a intent reasonable ratio was your Fight is call reached of less that the than proceed the earnings assume hazard case? you less have indeed X? this last hazard X. And futility it have analysis, on than you the Just the to on Is that a you

Helen Collins

is then hazard This have X. plan still Helen. that, our less that that passed is would And a Yes, that futility. than an to again, passes announcement ratio if be we have

we decision I think next been of that’s factors. where we what? some the what the And pass about of based futility about, questions the have on think okay, I is then do assuming multitude

Ross Weinreb

IHC what then positivity in uses secondly, Can also for trial on this you it. using for as trial overexpression. of the criteria And protein Got the assay X+ patients undergone X+ has or the percent here? elaborate

Helen Collins

Yes.

a has is patient trial conducted who population, – X+. for all the X+, being So enrolls meaning patients anybody test positive get to selected and the

not patient enroll. not a does So who’s have does X+ or FGFRX overexpression

patients enrolling. only have So who are that

Ross Weinreb

the Got it. Thanks for questions.

Operator

you. Thank

next Michael comes Our Schmidt question with Guggenheim Securities. from

Your open. line is now

Unidentified Analyst

taking Thanks for This Hi. question. filling my is Mike. [indiscernible] for in

me. from question one Just

mentioned that enrollment. us powered you study I assumptions the is provide trial to remind for color just maybe could was currently. ensuring or the some on what if You the FIGHT for adequately Thanks. know wanted powering

Helen Collins

this Yes. Again, Helen. is

will the ran there’s XX% truth. trial, that XXX benefit, is what show a is version of XXX times, out assuming and you’ve perspective, – you a particular I when particular talking we from been assume futility at talk or and about a the that your you analysis trial the benefit should way trial XX if of this is like trial has trial heard what designed the is times do if and what now this So that a about think is demonstrate X previously you a be powered us trialed another futility the you truth been know those analysis statistical it’s

making a this sure that to futility is cringing but show in trial that somewhere of run doing on from of the that this, doing my So XX description what one track at a times particular perspective when and statistical benefit. those we’re my you’re we’re of it’s I’m is statistician falling is sure

just study heard be I that think say you go. that’s – Bill is be heard get what that that will futile Bill than business will it and have management FIGHT you go And couple This I or not a no a is make will go about that who that not be the information But would did essentially being trial trial. demonstrating or of futile. there certainly help team be us so the will pass. you information on you did essentially people you to more pass, where why decision is on say a will with

Unidentified Analyst

you. Thank

Operator

showing you. back Ringo I’m closing to like Thank remarks. any questions call the turn the no in for further to queue. I’d Bill

William Ringo

Thank you.

As it to beginning we while programs, clinical call, the extends to a to decision restructuring at a I and meaningfully enables cash plan the long-term our said evaluating grow made prioritize pipeline. and advance prudently the our runway us of that implement strategies

In allow business and cash consideration future will programs to expect on into investments opportunities. hand that XXXX, readout prioritize us development clinical taking data pipeline our while we to

We for events, stakeholders. are important these focused on through as maximize execute advancing our value data our to clinical points on near-term beyond we and programs and inflection

I’d you us advancement and the collaborators the also of all I’d that, employees investigators all you. for our and to who programs. to contribute our strategic like Thank in to Prime clinical Five today. like trials, thank our continued patients our With participating thank joining

Operator

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

You disconnect. now may

Five Prime Therapeutics (FPRX) 6 Nov 192019 Q3 Earnings call transcript