FPRX - Earnings call transcript Q2 2020 | Five Prime Therapeutics, Inc.

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Operator

Welcome to the Five Prime Therapeutics Second Quarter 2020 Earnings Call.

As a reminder, this conference call is being recorded. I'd now like to introduce your host for today's conference call, Martin Forrest, Vice President, Investor Relations and Corporate Communications.

You may begin.

Martin Forrest

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

financial numerous and Actual Securities locations our these will are me the Chief Officer; research those under include Financial our David Act differ forward-looking Helen Dr. of and Officer. from those and Private Joining Chief Officer; our Tom results disclosed statements SEC Executive of section XXXX, statements from programs may including Medical today forward-looking regarding development Litigation statements Collins, factors, in outlook. indicated Smith, our by filings. President Civik, Today's Factors Reform due and different Chief Risk to conference the call including

change. expectations assumptions Our could and

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

Tom Civik

everyone, now. afternoon, near term joining and bema update nearly my important two Good new second been us on I've to milestones months provide role Martin. for results program. our discuss and four and data our quarter Thanks, in to an today for XXX for thanks

at to commitment So but story cancer be company; experience to people What time to on originally in Amazing patient to Five confirmed skilled with attracted science, passion option. and real Prime my I'd the better like to rewrite some short for comments my me begin talented initial Five Prime. and has treatment the been

have I'm to substantial continues experienced had our and work any business in unique these any or the adapted months, say to significant we Over of that delays not progress program Prime team new proud Five during pandemic. impact. challenges many few have and key make the last global the timeline on to environment we at times a

and three preclinical event we XXX Helen the bema last our to trial partners, and quarter into and advancing getting input Phase other partners will In my our will readouts to of delivering bema, Then clinical reasons. primary and provide team programs Five remarks FIGHT team, important provide XXX, After PFS Our decision study our a financials. with engage data as announced for quarterly the Starting David data with scientific will the turn the our you potential advisers and and today, endpoint. remains progress as near To financials. our program. recall, sooner, potential we Prime are two from and additional programs FIGHT sooner II on in term not I trials updates data made to programs resources reallocate this to on for positive. focused on and change generate update preclinical an quickly the

study in bema approved There more leading studying the lot population. initiated learned clearly so study. which enrollment two ago rapid We've need death significant is cancer. cancer therapy cancer over globally, of our frontline since are the to frontline new cancer new gastric When globally. the fifth a the ago. gastric than is decade cause this for the last for We a And cancer years gastric a need gastric therapies in here we and signifies of

now soon. collaborate trial scientific the with the evaluate expertise treatment desperately can approaches. is This results have for we FGFRXb. that cancer look We gastric estimate globally also patients and XX%. approximately leverage FIGHT of who our the tumors need where We We type work of drive significant new sharing of patient forward you to overexpress to the were determine that able number novel therapies, study in to to a frontline the

mechanism dual may that potentials tumors across was developed generate The CDXX-Fc clinical inhibitors. of agonists to to XXX on molecule is quite checkpoint today. results our use many broad were in and protein, report the both activity this fusion of the That's The Moving has Prime a monotherapy in determine why the novel action have immuno-oncology applicability significant. of that remains by We'll and end XXX, and to steps lines immune track therapy. XXXX. Five to this on program. for this program I'm information next we're the happy

dose, DLP where For we monotherapy dose with patients at cohorts XX enrolling to safety a clinical now activity. see and we no we've completed expect are a

a While monotherapy we also the interested evaluating of inhibitor. excited data, we're are PD-X and to in combination XXX see a

combined we that synergistic preclinical showed benefit. results when Our revealed these agents, the data

XXX As information in result the course we milestones. learned of very pembrolizumab. report are important to bema first are combination of study, in patient dosed pleased this programs and monotherapy I'm and will the this a in this XXX we evaluating approaching have a from in about And important we Helen that two minutes. our share what These more July. now few

of bema we've far to advanced program. the so to With work, it the turn me let And that Helen. done over

Helen Collins

you, Thank Tom.

an bemarituzumab. with begin on Let's update

on which gastric cancer, in to difficult treat the to XX gastric the and based months. the FIGHT progression-free cancer over five range. cancer XX with cancer to months frontline antibody, frontline of the changed And seven standard platinum The FGFRXb provides hasn't XX years. systemic median and a in gastroesophageal chemotherapy Our we're only in monoclonal only a in evaluating survival trial. survival therapy fluoropyrimidine Advanced

several Xb have antibody, the one to been bemarituzumab we FGFRXb prognosis been therapies bema molecular still FGFRXb cancer expression pathway a patients of all receptor FOLFOX-X gastric for standard, a to an have the line or frontline over subset factor over cancers specific over which evaluate fibroblast XXX gastric gastric the or short associated FGFRXb XX Asia, don't in profiles patients. In first-in-class isoform. and of gastric is screened or across even targeted first with months. growth an identified to cancers where cancer Europe. This has and The and and patients factor many gastric cancer, placebo. usual and front expression The growth bema trial similar benefit we worse In fibroblast of important study modified this prospectively trial, U.S. XX distinct for receive with systematically is double-blind a was for Although, receive than found cancer, chemotherapy FIGHT trial approximately found also to to is for frontline in up frequency XX% we and over-express regulation the is FGFRXb. the randomized trial

in As end or of we and early final remains next a blind double year on trial at converted to FIGHT And XXX track we read FIGHT out The II this year. of the the patients, controlled. to study. the are Tom Phase a after enrolling design highlighted placebo May, trial data

and overall how When to progression-free are early out determine the kind gastric by this secondly, FPTXXX used patients. However, drug immune the cells. binding we is Prime development protein. kill to the does our II and of now a data this And ways. that stimulate FGFRXb be by a T-cell survival, the to Five to to survival year it's patients. stimulates the end consisted the as steps trial or cancer typical year. CDXX-Fc to to know FPTXXX, might it available, receptor turn only that generating support the with soon on, binding Phase we'll drug a if next to work been endpoint and of have novel a Bema to can exciting directly Five the from the cancer. effective with as data primary the that T-cells, to as has and drug in possible. best first-in-class against By wants meaningful big difference and system two I'll directed CTLA-X working read benefit It Bema an inhibitor. Prime antibody company for in make to on changed this next data checkpoint CDXX represents will fusion

of the year in was continuing dose half the focus escalation. this Our first

being the been minimally enrollment fortunate by been in the South COVID-XX With we've has Australia trial the pandemic. affected conducted and Korea,

think occupancy with have best benefiting These trial which on which the is patients track patients that on are their XXX have with gives a will of determining this clinical them with Now by the to tumors. based a we year, have end the and infiltrating now hot which patients receptor chance program. focusing enrolling the tumors, now mind T-cells that dose we to XXX. activity in the guide This next predicted are clinical in warm the With activity. tumors like usually at clinical from reached PK, steps we're and the us milligram see enrolling we in potential on dose of therapy

patients As pembrolizumab. Tom with started in combination the treating July, the and FPTXXX of first mentioned we

antibodies and data preclinical between Our anti-PDX FPTXXX. shows synergy

has more There evaluate for So patients non-small initially the and may the focusing in by been interest combination are activity. allow efficiently benefit safety treatment. arm this clinical more investigators lung cell potentially strong to cancer preliminary to and we from on the combination

Finally, are to three preclinical on focus biological three therapies. with progress we continue programs wholly-owned consistent make These novel, candidates. on our anti-cancer, our

these data least at And and of trying call these two the we're novel year. and are Prime into one times. by the to in programs look therapies the turn we hard track work our their to over team these In to of actionable cancer David. programs to advance investigators now the cusp to sharing studies and Five for community meaningful the results expect the for to be leading with investigators of and soon. end patients, excited keep patients, grateful FPTXXX. We IND-enabling and the these sacrifices forward We the closing, families, the on bema on I'll

David Smith

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

share Research $X.X was for XXXX XXXX to $XX.X expenses second $X.X or million, compensation cash $XXX.X attributed cash quarter and license second The of XXXX position, to quarterly equipment. XXXX $XX.X costs, million October quarterly was corporate $X.X to clinical expense of exceeded diluted that of quarter and equivalents the depreciation XX, loss XXXX. for million general $XX.X quarter million $X.XX to cash, resulting compared The XXXX million of for reduced second the $XXX.X revenues. to decrease development compensation was Net net expenses XXXX. in the of costs. million $XX.X for laboratory par Collaboration offset sale primarily was of per marketable $X.XX costs revenue with miscellaneous quarter as $X quarter XXXX. the other a per the and essentially basic to second diluted partially primarily and with operating and and were due second decrease million $XX.X and second restructuring, sheet costs for expenses the decreased million General $X.X This was and lower XX% by allocated securities XXXX basic XXXX. for of or primarily quarter costs and research compared administrative administrative revenue decrease as the increase second on million was second to from strong quarter that our million. due or to totaled Turning an quarter finished by the which XX% from again XXXX of December lower of a XX, decreased balance the from of share of million and of June we on loss million by for quarter or

cash million, represents cash Looking million. result ability a marketable year-to-date in operating preclinical an with $XX our priority importantly, ahead, and between cash $XX as in our securities resources, that year This increase investing highest of be in expect cash, our manage And XXXX $XX while and used our estimate net year between programs. ending an full lower our activities and clinical end to burn. guidance cash XXXX we and $XX to equivalents more

turn today market Cowen to with to price in with common the entered over release put at million. We and acting of sales facility of our of portfolio. the Company. to the sell-through that $XX call. the practice. which company into the may sales and time I'd from agent, in an as to call We companies for financial operator also up facility the portion announced in increase Pursuant shares may utilize Q&A a this with to part company press investment back offering agreement like has Cowen aggregate good planning now The to time the place offerings as the our

Operator

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

open is line Your

David Ruch

we prepared This is on Ruch thanks recent all versus conference conference new it out for questions. I year our Congrats provide expect was appreciate or the you this you read color help the call? remarks, can last progress FTSE? later to of and via if the update update wondering Hey, guys. you the taking terms And afternoon. have expect could how a a whether Really medical webcast the for this in but on these just in possible is Jonathan. set for expectations Good many at David patients XXX just data

Tom Civik

Tom Hey, out my prepared Why to answering they and in. come there I'll best text would start here. the also manage David. the to my like -- with I closing for question as it to also I It's cut team as that up got second I my just don't questions a looks comments. do

are should we those tumors. DLPs warm So some XXXX I and XXX program we're one. finished may right where is now get close on team, really we where your it's without and David question in starting the efficacy any on when We've we clinical and expand dose advance a this tumors and with into believe be got cohorts to hard down hot about we important working see the and XX to that really call.

We but this said in with next be the do patients the know many we steps inform will haven't will our how program. cohort, that

We to -- expect we or also haven't how step. next that and our revealed this saying inform we'll but where clearly we're what the we'll today data, that is share have information when

Let color it she to maybe Helen can program. additional some over the where in me are we kick add XXX to

Helen Collins

add. said in know yet. to we're predicted we something as is don't as more receptor I the as data many again, external a anything announcement have fortunate as enrolling this we the potential we at that as much trial see in to have and of of we on again and you haven't I quickly we're terms pharmacokinetics we're and I dose seeing possible can the committed patients we're the Korea and David, as that so South to that we think Australia Yeah. but now said where occupancy that think I based our mean

David Ruch

there And could then from Keytruda that here a at the label. administered just combination. that any in start the through combination dose it. for just study. to Got clarify any a to could you modifications or higher dose of Thanks. you portion clarify the monotherapy is And in you XXX just Was if on things the there few read are as me, pembro allowed

Tom Civik

Helen, take down. why don't you

Helen Collins

Sure.

So, pembrolizumab we it's starting XX are full at dose and milligram dose.

at as you did where heard enrolling XXX monotherapy. in dose we the from we're patients So down

monotherapy to certainly safety have seen the at that but have so – we we've So profile dose that start to start allowed initially. it's to low exquisitely not with

So you've our starting we see potentially AACR, data but at see. been the may we will we again on and that potentially with based -- a questions that probably preclinical that combination, are so seen something dose by your presented have at

David Ruch

right. Right,

about could but Okay. else program guys. potential that just that remarks, just the Awesome. your if clarify by a you in then in anything release, thoughts press thanks I I share And could and the the on was didn't end the you filing IND you year. just of see mentioned wondering, and

David Smith

Yeah.

let David, Tom. this one, think, me take I

timeline announcement research our for progress well. haven't when that we So preclinical announced and assets as information our really the the assets on show we'll except for we're good this make We'll making some year. with

Helen Collins

yeah, clarify, say of I and said I'll was So, end by that just what the studies to and it's this hopefully IND-enabling year. meant

David Ruch

it. Got

and progress. you the congrats Okay. so for Thank again on clarifying all much

Tom Civik

David. Thanks,

Operator

Company. & Your Shibutani comes next from Cowen Chris from question

Your is line open.

CJ Zopf

Thanks CJ Great, taking This thank for question. Chris is you so for Zopf tonight. much. on the

to being. like consensus, of of look gone guys the of the cash give both expect that our Can When you sense projections ask sort financials. a higher shape us going is considerably burn end mostly? on R&D with to the up for the we are of the down, wanted coming coming year. at and of Just has planning down, I Should couple you guidance on going it a on questions what's be SG&A. than to be R&D Interesting where looks and see to

Tom Civik

Yeah.

that a strong started I'll financial I at get it think David. is over to CJ, ensure and a time important of me, again this really set – here that We Prime. important this story playing we here advance attractive the our to assets were I ensure to resources Let that reorganization get them really that at important. a discipline to I'll think had But in this got milestones major we've we've assets to and investing are most the kick then most through Five the went most

can financial I'm I that the some discipline which – picking that of maybe So up into you're specific this your David improved to glad question. jump were

David Smith

Yeah, CJ.

we mean the do we lab ended the didn't the from our beginning to had We – guidance the sale able what guidance provided that we guidance Our only for from the up year. benefit and ways of include one when the of half equipment did of payment equipments. realizing SeaGen up. I with of our were bring we license related

doesn't allocating the in just I year. bema something that year-over-year half as the half second allocated in assume bema, that half first the our that's year of – go. that a relatively uplift. – well. we function think a number of to So to also We're basis the spend and as consistent year, provided of costs the have that stronger reasonable it's so in where because of some second research, And of but on reoccur be then restructuring, of the the would a G&A but then, And with less it's is kind the

CJ Zopf

agreed as just where the you Obviously, analysis commented, scenario data Great, upon. basically as Have partnering are partners think the in the soon give seeing a thanks. be. data come you finally us trial where interested from final the available. maybe is before of could sense I through And discussions anything FIGHT discussions might

you Thanks. that. than or execute take process You'll longer expect little can be a able to R&D

Tom Civik

It’s Yeah. again excited the really Hey, the later see this this opportunity or year next early FIGHT about We're take one CJ. Tom, year. to trial too. I'll on

quite imagine, of can had bit program. in we've a this you As inbound interest

mentioned leading As in of my I globally. fifth the the gastric cause death comments, of cancer

are mentioned Helen is trial so well Phase to and patients give lot into really bema a dig need what that therapy. the us will steps that I'll for program. it. of inform has we'll many XXX patients likely with there done information the reiterate able new II So a is help be and next it that This and times,

So no in from with point that gastric the believe said benefit cancer outside program disease except United the about partner, we've that news announce is past could at we a to partnerships consistent what for this this a a is States. that people affects especially global

CJ Zopf

so much. Thanks Great.

Tom Civik

Yes.

Operator

from comes Securities. question Robert from next Your Driscoll Wedbush

Your open. is line

Ashiq Mubarack

of patients and type in etcetera, This be for And, you Mubarack right. further study for any combo you're super of I helpful, All yeah, is are just the on you thanks on could enroll. FPTXXX And other on wondering, looking was how thanks. the maybe to any Ashiq would questions. Congrats – looking details terms my progress. if at share I what status, refractory PD-X Rob. patients. details Are these taking any

Tom Civik

So Helen to I that think probably the question. best one answer

Helen Collins

Yeah.

is so are in and fairly time. that's close the The it's the this over off again team Because their with primary investigators a safety built interested inclusion criteria broad. are So, really I so this they is running hats right trial, investigators relationship I the Phase endpoint. to

to But day patients seen certainly, prior important details we we and therapy Australia PD-X this of all think in to out understand Korea, are efficacy and have even cell the to in are be of non-small so. cancer. I collecting age, the any certainly data lung going that South expected and extremely it's this, get are So that,

Ashiq Mubarack

a you follow-up had with Are quick make follow-up. tumor that types think to same able sense I inflamed guess, quickly with. might you be there other regimen I

Helen Collins

expanded. addition our Certainly, that, not could in quickly enroll wide do fairly we're flexible trying in could but the again be and that what some we possible efficacy of seeing patients whether can we are a we or determine we if but I safety, protocol course way so certainly do this to where think to

Ashiq Mubarack

you much. Thank very Okay.

Tom Civik

Yeah.

Ashiq, Tom, here.

interested think broad obviously we will Helen it to us the that depending we're it's a program. program in step this going likely to has across see we on lines. next and quite for we think in clinical influence of most is tumors as investing, to where mentioned, that and activity many I a what with And have start think see applicability potential we're the multiple

Ashiq Mubarack

you Okay. very much. Thank Make sense.

Operator

question next from from Your comes Guggenheim Securities. Etzer Darout

Your line open. is

Unidentified Analyst

for Hey, wanted taking XXX. landscape. still setting into in context is bar little for Paul I good advancing to of kind our is PD-X early a non-small on where on pretty Can on Understand add afternoon. a This the XXX on cell? and you Etzer. see Thanks stage the questions. for provide question treatment fitting a refractory for this you

Tom Civik

Tom it's Paul, Hey Yeah. again.

this just plan is about what it future the excited of of for applicability think relates program, We're I exactly the as to this broad really saying. was I sort XXX.

I to think making what advance where you've Prime about a will seen discipline decisions science. from to approach sequential the try take Five to

next combination trying set so that steps we study study, escalate inform in to else a the is to as and We're right dose think I information information that with now to from will that as make the I here. determine I program. expectations go. where Phase And the sure to get It the study, want right dose the learn we use continue we'll to we

Unidentified Analyst

Great.

Can XXX. So I beyond PD-X guess of where opportunity any combinations see kind you you on you that one comment for explored more. an

Tom Civik

trial pembrolizumab. our Right we've FIGHT are with events, near-term year, two and and year which and quite to bema of we got before the Paul, XXX end kick on be of early Both focus excited the able is next monotherapy. off this the our or those to combination now, trial

right steps be. pivot we next data and might us, focus them we sure those on get that execute make the to precision those quickly on for apply to what place plan where for can reveals flawlessly. We and is step next Paul areas and ground the with the a So, our now to on

Unidentified Analyst

a it. Thanks Got lot.

Tom Civik

You bet.

Operator

Fargo Birchenough from question next Wells comes from Your Securities. Jim

open. Your line is

Jim Birchenough

is Birchenough my thanks, This taking questions. Jim. afternoon. thanks And for Good

up to back XXX an question. earlier going on Just following on

these So, for response, tumor early have year at time scans to a if report many how we to want then and chance available of or warm/hot you response could with do give two end for think XXXX patients you two patients confirm scans. a on

Tom Civik

I then Helen fill gap and base. in the started you get Yeah. can one Maybe

I think haven't to patients. probably what number monotherapy patients to it's is we to have be determine of important said know believe what clinical step. is to the said we the able the determine year we have But exact and by we'll enough the next of that efficacy of XXX end

patients the this planning very are at We're And so our we point. to Thanks enrolling in clinical believe quite gone far to so, enrollment number Korea we of be investigators. and fortunate team our that Australia enroll, exclusively and South to well. has

got milligram we've the seeing do before the So efficacy XXX end get that how to determine, lot hope in of year a we dose. to confidence of the patients the enough if we're clinical

Jim Birchenough

there a a you sufficient back And obviously example, Is you. that terms going to make be rapidly. manufactured. then not assets could doing anything a the there just attractive doing is to in more a initiate Phase III product pattern, bema, of biomarker, thank for ability could Great, holding but the or

more For you product? example, make to do have

Tom Civik

to you and pivot that see probably when time speed we results The of This XXX. ensure a investing is spending can lot it Yeah. precision. on of with time my about last a that an lot we've we comments which, heard team in area the been is

really are all about hard asking enrolled what globally we like III is FIGHT the designed product, you're a we do. questions positioned a enrolled team Phase would Should we and has FIGHT the situation working in the see that trial so the that great We're trial? the from where things well that results And to quickly. unique ensure or trial protocol look extraordinarily to was

it that III roadmap efficiently, got trial a it wait II we do Phase about actually that then will see we're could help more inform, be the we're biomarker, Phase more going the it think Clearly used from could the right. going and to the progress great to as do that to we've we've information. trial. as to Obviously, we made here to So, could of what And specifically. data next leverage we relates

So, prospectively to on Ventana in the on also we've XXX interrogate patients we should really have population a that quite we screened be a phase an Roche We for next with into we as thoroughly and ICSA. ctDNA working been over a included information been that and bit moved closely so is plan trial hasn't we FIGHT studied before. bema And of positive.

of so we see information work we should I'm move the report the before that the now we're results So, lots positive. happy doing really right to with program into that data step and can this next be quickly the

Jim Birchenough

Terrific. and next update. look Thank the forward you very much to

Tom Civik

Jim. thanks Yes

Operator

Your line question from from Instructions] [Operator next comes Butler Tony ROTH Capital your is open.

Tony Butler

Yes. [Technical Difficulty]

Tom Civik

you've little issue. I had It one same connection bit seems got the Julian -- earlier. of maybe like a -- we're having a or

start Difficulty] You [Technical could or maybe. join -- again

Tom Civik

next to this and No. Operator, go we come maybe may back to one. question the can we

Operator

We have no in at time. queue questions this further

Tom Civik

time. one more try Let's

Operator

your Capital, Instructions] Hey [Operator open. ROTH Tony line Butler from is

Tony Butler

go Tom there Difficulty] [Technical we Hello.

Tom Civik

a heard hello. I

Tony Butler

me now? you Can hear

Tom Civik

Yes.

Tony Butler

Yes?

Tom Civik

you. Yes, I can hear

Tony Butler

Okay.

But screaming. Difficulty] my [Technical literally I'm and So, apologies

Operator

Mr. sorry; is line breaking up. your I'm Butler

Tony Butler

posting [Technical [Technical of Difficulty] Difficulty] XXX schedule The for

Martin Forrest

I'm Tony. it's here. Martin sorry Hey

You're really just breaking up.

is call you the apologize. been great couple I we'll do I from we'll Boston, see respond across mean in that all Tom to It's what in have and can So, difficulty. afterwards a think your had and but technical calling if we've been a of do way. we we call. question I state

the for list call. I first we'll on think after move be comments Operator, from you'll of Tony, calls So, Tom. to closing our

Operator

you. Thank

Tom Civik

to for commitment Prime you Martin. today. us. and maybe challenging I'd focus comments thank joining make during Good. I'm just Julian. times. for Thanks today their extraordinarily Thanks for be to to all proud work I'd like And team question yes the the for and like a couple representing the thanks Five these and

important monotherapy to asset. on all we're just and enrolling important focused obviously I today this hot most to or in-house data our on we're so for With I pleased XXX XXX stay and patients Five a warm prepared delivering II very and results have being very is heard to that advance with tumors that, this for year track late We're strategy to bema, today that soon We remain Prime. have Phase at expect you've safe. data This on now As and report year want end. milligram time us monotherapy. to joining execute to by year hope early for you thanks promising say next

Operator

gentlemen, participation Thank you conference disconnect. concludes your for now this may and Ladies today's call. you

Five Prime Therapeutics (FPRX) 9 Aug 202020 Q2 Earnings call transcript