Deciphera Pharmaceuticals (DCPH) 9 Mar 202019 Q4 Earnings call transcript

Good day everyone, and welcome to the Deciphera Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results Conference Call. Today's call is being recorded.

At this time, I would like to turn the call over to Jen Robinson, Vice President-Investor Relations. Jen?

Thank you, Michelle. for and today results. full you Deciphera discuss thank quarter fourth year and joining to us the Welcome XXXX financial Jen Relations President-Investor Robinson, I'm at Deciphera. Vice a the me Financial and President Officer. Kelly, Chief Officer; Medical results With Commercial to Chief Executive update discuss Sherman, Dan afternoon and Steve this Chief provide Chief Officer; general Matt Hoerter, Officer; corporate are Tucker financial Martin, and

remind not expected you this we facts Act that Harbor statements studies, to Before commercial like made begin, reflecting Private conference on status launch. are NDA would the call of Litigation Reform we and of management our our Examples the statements, our call forward-looking to potential that beliefs during lines expectations and preclinical of historical I are make Safe current time made of any the review submission for, clinical the provisions this statements of forward-looking and include Securities and XXXX. of, pursuant

made the on to differ Forward-looking expectations achieved. as results or execution to and other risks by of or that those our expressed obligation assure those we well forward-looking data, set Form that SEC trials, from most on no the timing include forth filings. any you Such actual this assume update implied recent the of our clinical uncertainties regulatory be statements. cannot of as study substantial statements uncertainties our XX-K, statements, in the We cause materially actions agencies and revise Annual and could call will involve forward-looking risks and Report

Company's replay on a available call, the this website, www.deciphera.com. Following be will

and Executive Steve? of Deciphera. the Hoerter, With that, call to Officer over Steve I Chief President turn now will

you XXXX everyone, results, this as clinical as Jen. and us full-year our updates. discuss well for you, on Thank and financial fourth quarter and afternoon joining Good to business call thank

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I Officer. Matt? detail, in over our greater call to the To Matt these Sherman, review will now turn Medical programs Chief

Thank you, Steve.

Steve from our robust derived difficult-to-treat needs control address well switch platform we all a unmet of have pipeline proprietary kinase medical inhibitors, and to mentioned, As research cancers. designed discovery novel

I our alpha and PDGFR like broad review First, to would progress inhibitor. with our ripretinib, KIT spectrum investigational

regorafenib, previous and work including sunitinib we continue at other ripretinib advanced therapies GIST uses our approval whose of As explore toward imatinib, launch the with ripretinib, least potential line second possible patients. GIST and in to we include in patients for

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annual Beyond rare approximately ripretinib, localized we a developing inhibitor our highly of disease of are selective form with for the tenosynovial the DCC-XXXX, of with TGCT of an U.S. in or focused XX,XXX TGCT. cell on the the X,XXX patients rapidly tumor is CSFXR for diffuse-type estimated and incidence disease giant

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initial Last We profile believe more unmet three that favorable the clinical effective proof-of-concept in diffuse-type the DCC-XXXX one, the with all Meeting. with has data and baseline patients an preliminary potential scans. cycle to patients Oncology safety first treatment we Society three with patients presented TGCT showed year, reassessment TGCT. day reductions respectively. activity for medical for fulfill a XX% Connective were of tumor at the anti-tumor preliminary three tumor as XX%, Encouragingly, Annual XX% the from Tissue need At at first

reduced the and patients. no At X diffuse-type XXXX, months, investigator day well treatment-emergent was as of mobility reduction tumor one. cut-off one in pain confirmed observed. DCC-XXXX higher the events observed ongoing which baseline adverse by for the partial nine was the date response, grade XX% TGCT were as XX also of data September a improvement Symptomatic tolerated patient had from reported generally in with or Cycle

X we open XXXX, X select TGCT portion the expect and in study Phase Phase patients. In expansion of dose the to a

We on to are to portion TGCT year. X additional continuing patients Phase presenting this data of the forward second escalation these dose patients in of in the ongoing and enroll study look half the

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I the Commercial commercial to potential Dan? in Martin, our launch U.S. Officer, for call the our ripretinib Dan of will over Chief now discuss preparations turn to

Matt. Thank you,

about for unmet excited patients advanced for tremendously needs to are ripretinib We potential GIST. address battling the critical

you first-line survival progression-free ripretinib. know, develop third-line rare need a and who GIST treatments modest resistance patients confirm with benefit unmet and benefit to overall second many compared no As Current for survival of significant cancer placebo. is to of

Analysis non-GIST of of studies who have typically with number newly metastatic third-line the GIST progressed XX of therapy focused given the of widely more U.S. mutation. in understanding the are GIST has there exon after claims no patient those progressing in GIST. epidemiological our helped patients for currently and treatment patients who to on receive harbor disease. opposed rate a journey patients X% used on to majority X% except the options for Further, existing as imatinib GIST PDGFR-alpha data treatment diagnosed who refine for challenge advanced precise Determining approved that indications vast on are with therapies to

estimate that in analysis, treatment. second-line incident there this for approximately the U.S., on eligible Based X,XXX patients we are

have patient is post-imatinib Phase the of Second in population is INTRIGUE ripretinib for study. opportunity as always the the setting long-term that we focus primary viewed line and the the X

the incident approximately XX% therapy eligible subsequent in due reduction second line or discontinuation Beyond the treatment population participation line, in each treatment estimate in we to death. to XX% of trials, clinical

In looking have Irrespective of think on market therapy, those ranked GIST addition what what understand clinical GIST to physicians as of better safety progression-free their in extent, could treaters new needs. extensive research survival therapy of as these for we've claims and tolerability analysis, treating they and to well are most to markers address line conducted benefit. overall ripretinib consistently as valued

gold And efficacy as the profiles to after from INVICTUS X to fact, the which confidence and profile physicians ripretinib other INVICTUS further treating the in the for the therapeutic blinded placebo consider interest Phase options, data. well controlled they in as their as high data be study, for the enhancing conveyed product as ripretinib GIST safety standard well reviewing due

on Sarcoma exchange. our and place engaging in ripretinib. for experts launch Under first medical leadership, approval FDA that pending team scientific of affairs track commercial preparations are our our Our MSLs in is are Matt's

launch. On the defined commercial has program strategies a awareness marketing the go-to-market unmet our need GIST side, raise our and for disease of education in launched team to has

optimal on including access access our Our ripretinib, of out program. team ensuring approval patient patient on has building focused assistance

for of these drug, D can you programs the important patient as benefit oral result in that oncology affordability the due As challenges often Part to especially are a know, any Medicare arise drug design. oncology

recruiting GIST we've size structure. force representatives. identified our they of are season defined leadership sales organization, treaters sales who we've and sales practice. We've team, sales top Regarding built an our and our of where launched incredibly We and

company commercial year. virtually We've pleased of oncology which very capabilities and launch the the bringing excited with individuals We're oral the deep from and talented pool, extensive composed help in leading patients and ripretinib we're to opportunity candidates with and been grateful industry have pending to oncology the applicant tremendously about experience. approval this has includes to every extremely building team

to Officer the our Chief turn Tucker call now over will Kelly, the financial review Financial I to results.

Thanks Dan.

have few quarter capitalized We'll and results. minute launch remain full-year execute opportunity to we XXXX We and public strong from completed that million a February, financial the potential equivalents fourth XXXX a highlights in net compelling clinical discuss of cash, approximately to well take ended a proceeds. ripretinib in our $XXX and of cash And of with and pipeline. million. research offering We marketable a $XXX raised we securities follow-on with approximately

for Based will and on and million well million expenses the sufficient into activities we clinical in our as be development and fourth increased as on million support to the operations $XX million, that XXXX. of fourth selling, to approximately were our of half expenses $XX plans, second CapEx general our prior based were quarter quarter total ripretinib operating to potential our the increased expenses approximately the $XX increased $XX from In XXXX. investments XXXX, launch Research the current pipeline. quarter of cash commercial expect administrative of fund approximately development across and

expenses our now commercial and as grow build expand the over to call that, organization over turn coming with the expect back activities. we to quarters I'll And clinical We Steve. development our our

Tucker. you, Thank

prospects stage made clinical to about company a for of exciting the excited in to the to the our a their of Deciphera for research thank and mission all of developing our aggressively very commercial team treatment We're proud to did take as like new look and here are moment entire we we and transition at I'd important cancer. dedication of progress the pipeline. XXXX XXXX into for medicines

line I like Michelle, would would the to questions. open open questions. call the Operator, like for to for that, With

[Operator Instructions] from the first of line And comes your Fye JPMorgan. from question Jessica

what's trial? this With when for year, estimate of we'll the expected on INTRIGUE that latest enrollment for the completion half in top line your see back data

this guidance then be the completing And of reach have in to when time second disclose year. which we would what potential our is So not for as to of of changed in we study. readout our full terms being timing the enrollment, we anticipate enrollment, half intent a the

get profile, what can on control, hazard of out. do second over will I a Voyager watching ratio, What when Maybe Is absolute for reads focused you that avapritinib in Okay. months it one. you improvement the study data be set? safety must

in our Yes, Jess. question, based really totality reporting of the I terms line in we're on good mean, data, understanding interested top on the of data. Company the

into, interested of and with the level we be view in the risk current what the the of on depending So profile avapritinib. total for detail they the benefit data, get will and compares like how label that

to coming forward look data the in we here So seeing quarter. the

next [Operator Sandler. from of the Instructions] line And Chris Piper your Raymond question comes from

censoring I - about know I higher Just rate disclosure little than guess being expected had question the in you on INTRIGUE. the a upside. a

comments, sort of communication if about give forward. I'm but wondering talked indication a bit prepared your in You cadence this more I little your color you or going guess can of

we announce perhaps just you on expect other some any curious how or to that sort you enacted when should forward? of of that and would So that will actually get intend see if fashion, decide in to to I'm clintrials.gov upsize it, sort will, going of do and changes announce actually to you as you kind communicate you that

mean, unchanged. me INTRIGUE I say first remains our let confidence that just in

that our some on we as will to that a when remains to on the and sure patients report then expect out. as will investor to that as our the additional that study And provide decision number time the adding well when half, mentioned the make probably disclosure second at the same we there. will make on guidance earlier, enrollment, just reach clinicaltrials.gov So information out study on be the I make we final full of is updating for once both then deck guidance I

Great.

but Okay. ripretinib for I'm for either into label just I would PDGFR guess launch sure if one but couple question launching different a scenarios, how or your fourth may this, broader both preparedness, about those with line not you And is just want I you're XX be I a got you you be, that exon think then how plans? planning different a with patients you'll competitor talking have imagine label. to different, alpha are the answer of scenarios

Let that, some to comments it I'll a me over more Dan make few on to advance flip then color. add

not view profile see class to study you the for setting It's the in we is ratio ripretinib, As that in or of drug for PFS think data as we about and support X.XX. overall that a X.XX. of In that our this study, the acid basis treat we a generate have disease. bus for X.XX, matter a the to drug common is case, that ratio the product, hazard being the survival the NDA pivotal this the randomized supporting

of So this and drug signal the INVICTUS we've tolerability compelling, well-tolerated is, X very then we was with Phase already set in is generally I terms know the consistent of that published. of the the isn't our profile think broad very from efficacy and data that profile drug

confidence terms view think So done we degree we've will with potential research I his prepared that color. those have add some Dan a in in how physicians Dan, additional and remarks maybe some high physicians he of of prescribers will data. mentioned of with the

great clean, for I survival for up and which to helped these prepared profile. options has and safety in market treating focus unique as space survival about really physicians think patients. we overall the on in in mentioned progression-free my a mentioned we just really the about, placebo, relative to looking what in have it's course come, and endpoints they're say more but shape to addition But educate research when Steve tolerability remarks, our treatment is how of the So paradigm to what it's really days us may

show came did to us profiles research in their and ripretinib. when a product we're space, like across for ripretinib what really we tell level other interest and as what back That's consistently treatment options was the as well blinded looking the they

In of in about fact, the product profile in patients one study, XX% of in for GIST. with ripretinib's be did interested a respondents said we they'd treatment

impact are really real possible, ripretinib think on have battle as can their focused we So as it how they get quickly we because positive we a can best patients disease. to as

And question from the comes [Operator Eun from your Jefferies. Yang Instructions] line next of

compared But weeks GIST, second-line of what on for study, benefit at you've shown than be with you based would to in clinic, the PFS in So, have XX X. has more your improvement look conversation kind Phase that so X sunitinib? what when meaningful Phase PFS sunitinib compared of shown the clinically consider would to they a oncologist, minimum

second-line end from X, So year on of cohort. the a you're recent survival that is for progression-free the have that cohort right. update data what XX.X-month shown from those based In Phase our last

that's look that course, comparison you setting. do a really that the Of his you in on represent and substantial relative difference offers. just at non-randomized cost But this And commented prepared a Matt the Sutent think what to I mentioned setting if remarks. label, does Sutent

- progression-free in months. clinically a context survival would that two meaningful the difference in months the So on think of three INTRIGUE, we of be range to in

setting. we we based we've optimism we view for mean, potential lot of patients generated that in Phase certainly ripretinib so study far, of in the that terms on have how in think benefits that offer X the I data a the

And CSFXR Okay, inhibitor. on question XXXX, thanks. one then

to faster? think into you registration recruit do pexidartinib in patients move you when So to to need order you trial, compared

toward some on clear not will year end the provided as data pivotal us provide what to yet whether would and the it's that be the said, from we X. design this that So we for Phase guidance of we've additional update as study

a but to of other with going are different is could I and One a options. and the study, data, then some determine need study variety pivotal be. course to there can more study be we generate some think head-to-head have our strategy regulators of what potentially placebo-controlled be discussions a

at information of end this that additional we'll the we think As I year. said, on some have

from And Schmidt your from of comes Michael line next question the Guggenheim.

questions a just either on gotten wanted stand and is driving the INTRIGUE is what now trial of you on against the disclosure. of the suppose of level could I fair been and sort I amount of follow that rate help maybe arms. those there in what's higher-than-expected from dropouts of your imbalance up discontinuations a to confidence We've

Steve. It's Michael. Thanks the Thanks, Yes. for question.

of confidence And guidance the As remains I that INTRIGUE of to think same iteration remember of powering in been earlier, there noted is it's study. or enrollment. study the our of in has in no also required number events alluded our I terms I the change unchanged. important that the

the about a fashion in a this readout is really timely So study. for enabling

censoring a see is you of terms the seen censoring. study, where phenomenon of on in event-driven study In this any oncology,

and to surprising a for confidence that ensure So of the that readout we this it's we study dynamic not that's adding that us INTRIGUE. see timely something that have we subjects can by number

we full to forward generating will then of data. course as to So noted we study. enrollment, disclosure potential readout on for reached when And the the I look we additional some time provide

from that And to see in this what cancer I justify you second the additional in that of half potential this then data study in these as types an some you've you mastocytosis to of of regarding systemic trials to like of think And steps predominantly in should other guess we from the year, indications? X arm the about the any update enrolling? I and potentially guided update guess would Phase order from further type other cohorts been of the that next or ripretinib

number ongoing in a cohorts including as in expansion of mastocytosis. know, have So, X, the we you Phase cohort the

KIT-driven cohort a in have We melanoma.

We have a GBM cohort.

of in investigating cohorts to the tumor other potential role types. for where we're ripretinib a number play a So

year. our is a well. a of one from as potentially one as further noted, those those be cohorts of our And hope is provide cohorts mastocytosis and could least So, that data an to you guidance of update at lot within

depending and data. And this enrolled patients getting of course upon is generating

these comment to it's for me further premature any So what of really be cohorts the that study. on in bar would warrant

we'd course the I additional present in see that some data a then of the where time, at data, we color data be to understand think offer mature, and the from might think on go we need position there. I to

then population updated some maybe and Understood. should specifically provide GIST the more market about think did opportunity GIST? for in the How U.S. the Europe you or treated we identified in And potential patient information U.S. ex- in on

Yes, let me - Michael. question, good

to let start Dan and the to me he then answer if with ask offer off additional Let that some any. color me has

in we incident the GIST geography in didn't versus any any this world. the around So disease, population the expect is of other different U.S.

best the look estimate way think GIST it to I generate at relative for to an the U.S. So in on Europe to is really basis population a

And if not to so, larger on population on Europe based would to I of have would color just differences. number that, know that. based U.S. expect additional offer you Dan, we see in only any the you on relative don't patients

sure. Yes,

Thanks, little a bit. Steve. Just

to European extend X,XXX there newly Europe with The in incident to per that We Society. patients X,XXX Steve together, to that GIST, parts bring new in patients was U.S., in - approximately and you patients think American of incident whereas the and those Japanese the world. X,XXX you the when Japan our is as GIST So rate population, new would Cancer mentioning we think probably diagnosed incident

U.S.? the be a that And we then numbers guess second ex- haircut, line, to to so speak through fourth I to get think would those when similar about

and terms what of of receive the those further paradigm lot in see one. any that in haven't territories you patients assume similar to in therapy receive provide a it next then Michael, we progress guidance, with would primary but as research would treatment the be yet, We to and need treatment substantially done

of your And from question next the from Robyn Karnauskas line comes SunTrust.

original you on a NCCN your the I getting Help couple that were you're on why approve. give you're may guidelines And thoughts have in going? you these and how what assumptions data. pretty program protocol? you're in differences upsize Maybe And some the that once maybe censoring of on of original but to then included you. want us those hurdles early know because think not understand the - third, access second, Just your your like feel you guidelines, follow-ups. the seeing, got first the about between you like blinded ripretinib you trial surprised Thank your that quickly. - Maybe on any assumptions that there then seeing is maybe

Steve. Thanks for question. Robyn, tripartite it's the

and try me one one. knock Let off these by

So guidelines, the encouraging treatment the we the it's chose compendium act guidelines post the NCCN quickly in approval NCCN think terms of to of in to update so avapritinib. the very that

I part is of potential the for and are in generally need. treatment in reflected the for And need think that excited about unmet patients how unmet speaking that options GIST given physicians their new

ripretinib moves that approval So U.S. the how would expectation be NCCN quickly then the and panel upon that evaluate a potential determination our a make the of of in reflect to guidelines. data our in to

update maybe on part second think EAP. I the brief your provide related I a Access So, of was question we just And the launched. I Expanded can think to the Program that

this in the very pace in and that we've in EAP. on enroll jurisdictions U.S., a in with patients patients offer the a number the I of sites enrolling the subjects pleased of Europe, variety we're EAP is population. can that general of different of on unmet and variety geographies the need other of opening and view again So U.S., seen that the reflective Europe have now we medical is the of our different in again, this beyond in just

context. in see that we're ability So the pleased ripretinib to have access patients the to

as there's patients to are part So way Generally, do of that subjects think have adding where oncology I then you think I find And I an it this think think studies with noted, INTRIGUE censors. we in why with and about the Robyn I this. easy to third ourselves is your was, question kind study. to event-driven had the phenomenon

come it's subjects probably conduct has be the not able think therefore, NB you when out, how set terms And to study. your the you assumptions course is that the the to when to of So the in and actually this a company realization population. of many should in what this add - initiate common be censored subjects certain might to entirely study I set study, early of in overall enough

see to the we is study the that will simply of number a companies Oftentimes, waiting delay report of they're the events announce out there in as do for is accumulate.

So when It out that. the we little in made INTRIGUE when was turns off certain bit assumption assumptions of mark. the the protocol written. may based That study have of a our case, with set some a early - indications been from on

And get we've this reason the a just requisite taken we the approach events timely of to so, ensure fashion. number in that's to

And of Securities. from comes JMP line the from your Benjamin next question Ren

study. talking how we about Could to many implement you how take little gating trial before once long on implement what get and the that this? sites it kind maybe talk and you've change bit about actually to the a a might change handful to the is decided tens, Are of patients remains does you INTRIGUE the hundreds such be factor added

Ren, the question. for Yes, thanks

working the to is So know, there has get probably number process amendment get still we the yet to through to get disclosed as haven't you reviewed it a one written appropriately to that And we're go out through amendment. sites. to as it

disclosures end we we're as soon as the on And will then that as mentioned I process, earlier. our of back so, update

with need at filed on guess countries for with we And board. is is couple a at apply is or kind that you countries then it and the If additional separately? of that were noticed, Singapore application have one potentially of get of the to least something we Switzerland, Orbis the I come those things that initiative automatically to ripretinib

Yes.

right. I think that's

this based to by have FDA's program Dr. think, is interviews try that least Pazdur, we've broaden on that over time. So FDA's based seen, given intent, I been at intent, on to

future. potentially I I did that Switzerland the you same article about Singapore being in maybe think read included and

I Canada are and priority that But mentioned, so we've now in the where the that countries scope are case, ones our received review. two Australia, within

going the And have those any so expectation that to we is of countries from number don't two. increase

you just and expect ripretinib would of application. So Australia it be can be Canada project. is for this that the One would part

half on And EMA second already the discussions are preparing then following just having waiting question discussions? is, for are final as one you or with anything in you the before had the have particular you

a in the half I year. Yes, we're of as noted, toward, working filing second the

to toward getting that disclosure in second working those be you and interactions regulators, MAA, filing filing us disclosure specific And haven't see that just that in so half. related from specific the related will about we to the the talked the the next with we're

next of your the question line And from Lawson Barclays. from Peter comes

handle, wondering you handle about a Just still do a censoring is you that if have Is we - of events as playing could think good or INTRIGUE, have on you still good do kind evolving? that out.

question. for we data. the was we thanks And very early Yes, mean a the - that good I sense that see the took what we the of in the reason don't Peter over we decision to to number No, we that is trend expectation any to But study. still of patients change going have of have do early. time. that add a it's have

that events So see we of to concerning it's I with addition predict, might more that's not anything the but difficult us. censoring subjects fewer suppose that and to

pretty We remedy a straightforward study. have a the of that for is to add and to this subjects number

we're So that. on working

same in? there looked the any that for stays enrollment subjects the to changes Will be criteria so new those

same. the say it's absolutely I'd

to changes about other enrolling number changes to to any just aren't requisite fashion, other subjects there to timely the study. in of the events is get a study. no So This

how we just should you. net just on, think thinking should we about pricing - expectations Thank be discounting about? And around any metrics

remarks just a over then couple I of to maybe Dan can so comment turn make on to that. Yes, I'll it and

they talking look value, understanding them them with profile and of you pricing So offer don't data with profile to know with there? now, eventually pricing us. as and Dan, physicians we're landscape I if we're the And right and for a we, anymore color want guide how sharing certainly will blinded course view decision that understanding product sharing doing how as to the now the the trying ripretinib payers same we for product they at view of

of Sure. for thank you question. Peter the points. Yes. Couple

GIST. perspective, research actually course and of to So, see I from a been really degree payers just of been the that do - we understand we've their in unmet the view pleased payers need. research to the have need in really appreciate of And unmet with engaged

blinded that in see so to this when can a ripretinib patients. to really, and profile research always of that. They the really and kind have so you could positive responding what for see don't mean product encouraged of You that these view profiles, we're also,

to on their bring And comment will the us payers ripretinib patients. that confident for it's can price. ultimately that appreciate premature that, value we're beyond So to

thing As it in programs, per on have the space, we drug one that tried is discounts, programs we relates, to net assistance importance while this patient mentioned gross drug. oncology to you free se, wouldn't oral of comment these underscore any

programs result are Medicare These can arise important Part as D just of patient given benefit the that the challenges design. a affordability

models. to want mind in thinking about your you that as keep something you're that's So

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

future initiated starting combinations thinking Maybe with when and and in might on start regard have Thank might you're or interesting within studies. you is checks setting physician if try. trials, suggested initiate particular if you I I curious just that to a you. respect might line potential some earlier to trials you've First, that up. or ripretinib in follow then was when some be elaborate

Steve, one. Yes, for I'll take Thanks sure, question. that Chris. the

INVICTUS ripretinib yes, patients. offer and data, investigator where is places other example and possibility, tolerability data based for certainly we be combination GIST with So some good I ripretinib therapies in the on thinking named might benefit INVICTUS other a think you this the partner. to that be and ripretinib the for there certainly of for profile include could enthusiasm lot drug think the suggests for through the the we're combinations disease that in to And might a of for certainly able potential

patients. the to where the in data I potentially settings offer and drug we other generate think that there disease demonstrate are could can And meaningful benefit

pursue we just that to specifically. us next actively intend INVICTUS those determine and we the So, data now steps behind and have

the and hear the of you we initiation might they when on studies from initiate? When might

on you don't us - talk for little haven't we studies. guidance Chris So any specific early for about that. a for I It's additional to planning have

time, certainly initiation. we'll on the right at thinking study So, there and provide on update an potential our

contention them? setting second-line your or the in and mind data in studies terms up be upon it starting of those Will

Yes.

I have clear we very INVICTUS that on the data, it's the think disease. in view, strength this point of of from based our a very drug active

as I any But for strategies to XXX patient we to addition in have X. to other at to wait of ripretinib GIST. from additional INVICTUS us the guide data course the you see Phase accrue any experience need look and to know, with So us wouldn't for clinical

ripretinib So, basis GIST and we've of generated additional we think disease. I have to a lot and information data consider clinical the we that need with of steps the in

And XXXX just if shift to for second. could a we

data You with of there. X the year. guided this to trial we see - start data looks like, so details How some half many running was great. dose Phase since then anyway, delay - me be second wrong those would And time. what's and to data me I'm it occurred both it selection in the accruing correct secondarily has XXXX, wondering, updates patient and providing patients might XXXX, of study the just on the I early here been if updates in some But about the that

Yes, Thanks thanks for Chris. the question.

reported we the this X the And Meeting. for a Triple Phase first at So solid population. patient time the wasn't tumor

move cell So as last early wasn't a might disclosed year tumor. tenosynovial until recall, it giant think company into I you the

three presented in Connective in at Tokyo it result that declaration these patients was data initial think the November, that we started to Oncology to one year, of enroll to had about conference way referenced the Matt the - made of the it then that that the so his that we And the patients in sites in is, get open and Society was last remarks. in disclosure Tissue prepared early that

been sites on additional study, the the frankly. that's actively kind so we're of history opening So

enrolled the on that that we we've sites additional additional report opened. time cell patients while with we a in provide expect half, to of a focusing have We from the tumor, tenosynovial actively patients enrolling have on in specifically opened additional of on TGCT second number can't I giant now number Phase the subjects X. guidance might to the over sites And study

biology. know, So good drug is cohort, We on receptors then for by make And XXXX recommended very open of selective in mentioned the again, target. we patients. this driven Matt a based here TGCT. in This again clinical think expansion intent of remarks, number his And data, know about is disease have the the results an to the think in it's the steps a dose, next prepared that, translocation ligand is for determination inhibitor for get genetic as a is we'll we of a we Phase and to the that highly that straightforward. over-production also a X

future us disease in to suited So relatively well registration. with for we think briskly move it's XXXX potential very a this to

sufficient pivotal I the up to you clarity share trials of helpful. to then data yet. guess second in just half provided, be in into your you'll minds just the the will And progress that's some Great, follow on

to way it? data you. - data? to you cohorts. expansion So then you comparable with think much from data make see I we Thank we assume, for that said, opening right need Is And the about data the and We'll the mind currently, be is cohorts. for to in it'll might some expansion longer have help be pexidartinib your to How to that some wait decisions. that have your

me into right XXXX a as data with matures, then be in and because the that determine might at comes exactly it time ask we on comment depends we're That's and launch it's for data to question to in ready, study to data ready when pivotal this premature I disease. And on this just when potential think. will and

are So just difficult forecast for today. me that to we from where

from Andrew question next comes the of line Berens. Your

Congrats see on see do a there where systemic some mastocytosis assuming conferences I we the presented this might of on to and I progress, said planning to are data the guys. INVICTUS all too. you we questions on A near still data prepared have comments, in may that, medical the couple but that still year? be future. follow-up going any planning, are Are missed this have in the And we

It's Yes, Thanks sure, Andy. the Steve. for question.

would to from beginning would and expect guided of the or cohorts systemic the yes, have more one X, include is with the Phase that we've data mastocytosis. to and since what we ripretinib from said So that year expansion

of data medical So is that and the conferences, our that of are course, with hope, of speak get enable to would during course, published. the year experts there us course and

So focus. that's our

that patients arm, presented phase remain my believe where of regards seen dose anywhere. progressed, believe again was able it's enter extension there recollection, data the on on I don't And extension an to were we've to phase, INVICTUS, those to I then the ripretinib. either double in

have patients patients on So, that see should the about we when are the potentially also QD? the than to XXX those think more normal, we the And label? then going how

So in patients actually then right. to on the study, Phase started escalate BID. dose the dose central you're patients to escalate XXX off in similarly X the BID. opportunity And the INVICTUS to who PD the study, upon XXX the arm Phase had In to X opportunity had the ripretinib also in

specifically, intend an think can't guide analysis So it but publication, certainly analysis might we for to set that we I publishing. going on interesting you of that ready have we when is that's that an be data.

in So of working analysis those plan that's and publication something terms on data. the team is that for

Okay.

the second to Second question? Andrew, part what's part - sorry, that

Yes, -- it is

on the label. Yes,

I other the think was part.

Would Yes. the those appear on potentially? label

early Yes, me too it's on that. it's for not comment - to

in terms label. in the is appears to decision going FDA be know, Of course, what you maker as the the of

and see ends a looking I label the with up to the we'll potential case QD final assumption that be based but have discussion XXX it's what's think base that like would the goes, approval. on how dose, going be to

And Canaccord. the from of Arlinda from Lee line question your comes last

be for go-to to I going that Is just we non-GIST on there? might be a decide to sufficient any additional to GIST that see data wanted the update going And to Phase on indications? data expansion clarify X for only ripretinib. Or is data phase?

Yes, for hi, Thanks Steve. it's Arlinda, question. the

right. that's So

to at of the the what during this of from year. we've guided year, have that in the we'll So half cohorts data one expansion some of second is the least course

to for not lead us. too or may data me those may And where early it's on so comment

data present in a at some to have we once the data we totality at position I might look them be those of think And of half, presentation, and that data. where matured and that. color the then So the with are second at on we'd in the additional to time we provide time, go

to for the is that at data end, of mix year be inhibitor expansion? sufficient an on help - decide similarly then going And CSFXR on the to scope Thanks.

Yes.

a the question, on the I had same minutes of depend ago, we the of think, Chris, have. will that data couple So, totality and it

offer year us sufficient to might us the it'd can his are for So I whether the that's actively have open, be study. what stage team, whether balance requisite broadly, I patients getting on we step. sites next to just decide put and on going operations team working or Matt very getting development at team on that of the clinical end for be to the comment and think it's portfolio, clinical the clinical on premature our

So share with we're more with investors in to potential we additional data, steps can each programs. that looking and forward half to data the next second having community guide of with mature these the clinical

conclude this does like I to hand the now And Q&A would call portion. the over back Hoerter. Steve to

us evening. for all on at interest you wish afternoon, wonderful a and continued Deciphera. of Thanks much. and call this everyone I you the for thanks Thank joining Yes. support us your very here

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

disconnect. now may You