Deciphera Pharmaceuticals (DCPH) 4 Nov 192019 Q3 Earnings call transcript

Good day, everyone, and welcome to the Deciphera Pharmaceuticals Third Quarter 2019 Financial Results Conference Call. [Operator Instructions]

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

Thank you, Bill. to Deciphera's you Results. Third you to us thank the discuss Quarter and those joining of today Welcome XXXX Financial Jen Investor President, Robinson, Deciphera. I'm Relations, at Vice provide to President Hoerter, Chief Tucker Executive Chief quarter's With Kelly, is Sherman, and discuss Matt Officer; this corporate update afternoon results me and Medical a Officer; Chief general Steve Officer. the and Financial

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

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

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

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

call via welcome everyone good afternoon who our update and the listening first to you to like all to provide Thank a conference corporate I'd results. and call webcast. general is you, financial Jen, the on of to and joining

our Pivotal GIST. data Phase progress treatment gastrointestinal announced made for ripretinib results X pipeline INVICTUS the across set tumors product over enabling inhibitor lives proprietary we data Study transformative for to the importantly, of the importantly with our positive These of for improve kinase representing clinical last Deciphera or a people of from mark milestone quarter. the strong have Most first our potential switch candidates our of control entire platform validation significant advanced registration We and and cancer. the stromal

the disease the For new has believe for there effective We as with whose GIST progressed pre-treated transform currently treatment deliver demonstrated therapy control. can people therapies landscape the with this living to approved an effective and treatment after patient GIST, disease urgent potential unmet that is heavily population. serve drugs, has ripretinib need for an

collaborative as and the Therapy in very with that patients has or We the which New toward sunitinib agency, to ripretinib, submit first a Designation prior advanced XXXX. dialog granted our to the continued we Drug Application treatment treatment regorafenib. we received NDA to with with announced expect work FDA we imatinib, GIST continue of of forward our quarter submission the for for look of ripretinib have who Today, Breakthrough

are potential the building company, stage affairs and transition for ourselves from ready a development stage capabilities. commercial focused medical we As we a our commercial to out on

the you United to ensuring coming look to States, planned positioned of committed are well in these ripretinib approved, on support efforts updating to the we're forward launch We that months. we the and if in

updated Boston, last These inhibitor all product exciting pipeline and week triple so stages owned data kinase from pipeline generated presented we of spanning a called from DCC-XXXX. Beyond At include all programs. AACR-NCI-EORTC oral development of control candidates of platform. wholly our switch ripretinib, the rebastinib DCC-XXXX, diverse we or and have our proprietary all meeting, in and

Officer Matt Officer. recently Sherman, I him development the Matt detail, look hematology, these clinical the a a contributions in we most to of Chief programs just years oncology in brings in important of team forward experience over of I'd our working as drug XX already now like introduce and review to Chief recently of and Acceleron. greater physician Medical To as appointed and short Medical In here rest our period time, alongside Deciphera has as advance to pipeline. Matt made scientist

updates. the for of to I'll Matt turn overview now over Matt? call an recent program

advance has this is This of kinase robust pipeline Deciphera Steve. time. are to switch late at you, grateful control of such cancers. as for Thank development, honor address I'm help proprietary in these to impressive to to therapies deeply stage exciting to patients spending unmet and joined novel which programs much needed forward an alongside inhibitors platform to the and have shape knowledgeable generated novel kinase Deciphera's opportunity preclinical designed all team. and working need truly difficult-to-treat look a deliver to

overview I update provide with an pipeline would now starting and an give like ripretinib. to on programs our

to believe imatinib, treatment are patients X ongoing demonstrates and who study We for the treatment landscape. setting. no with to data approximately and in GIST INVICTUS perspective. the secondary regorafenib receive was comprised population the patients drugs. in in generally ripretinib received mutations of frontline study these to the put After post-imatinib mutations currently which Before X,XXX develops, the into patients of with new second-line mutations; the data, with estimated diagnosed There to emergence we treatment important therapies is the are and imatinib year, ripretinib to sunitinib US approved both each of X% for the GIST majority Phase the KIT an from into three third-line X,XXX in potential gene. setting; have the get due in primary resistance KIT which the move secondary transform prior it the

or of progression improved death disease hazard a Ripretinib survival The the a less of a placebo one progression-free arm, PFS to achieved month with PFS X.XX. months primary of by significantly compared with risk endpoint study median arm its ripretinib INVICTUS a than or the p-value in with XX% of X.X in reduce ratio of X.XXXX.

significant. overall survival ORR, clinically of meaningful hazard a X.X% or endpoint of or X.XXXX. of X.X XX.X not a which Ripretinib also of secondary p-value with placebo, rate ripretinib a key OS a response X.XXXX, rate the of with showed improvement the months statistically p-value compared for placebo X% showed was objective placebo, versus X.XX versus of median with ratio and months OS for of nominal For

was hierarchy tested the of This formally do not the statistical plan.

drive or the pain anemia, presented and in was ripretinib in and adverse from well patients Additionally greater treatment-emergent hypertension Grade tolerated with events than four and in generally data X% study were the data X INVICTUS can abdominal overall arm events consistent adverse for three were impressive that Phase results. of mutations ripretinib the these benefit the particularly of in believe and the observed pre-treated improve arm, GIST targeting safety broad magnitude placebo most in of the are anemia. highly known We patients. and survival suggest outcomes of heavily approach efficacy spectrum to ripretinib's

the We with submit the FDA in look for to treatment quarter actively for our advanced forward patients. to NDA an to of option expect XXXX We the potential deliver to agency ripretinib on working to treatment goal first the with of GIST. patients this

starting to ongoing results ripretinib reported place GIST week, with of dose we the XXX X of triple the daily. Phase last Turning meeting in milligrams took study from positive patients, updated the that

assessed therapy matured to results data like duration In lines clinical with PFS with second cohort which the in X how activity an measures increased randomized second as the highlight months of XX trial the would very particular, data by XX with confirmed of across the was patient five Median Phase is response additional and same from all line of I patients of have the to of INTRIGUE. there median and are weeks. XX% investigator. ORR pleased of subject XX a GIST, We is all population, the our with ongoing weeks

with recall, X.X%. centrally standard data a the in of for sunitinib, XX.X read PFS will second-line published weeks GIST, you from confirmed ORR of As trials median of care demonstrated pivotal the and

In or which lipase pain. with previously treatment all includes events generally weeks. treatment-emergent X% patients was anemia GIST. with Grade the patients duration increase were duration, abdominal adverse consistent of that three level, than well were increased data X more in dose of presented tolerated an lines were adverse XXX Phase in with updated patients longest Ripretinib escalating, and four across addition, events in treatment mean treatment and the of the

support great progress making these currently the in with data believe along Phase We're have in INVICTUS patients sites we this enrolling data INTRIGUE ongoing X GIST. to and the opened XX continue XX We activating in second-line study and countries. sites study pivotal

programs working I'd spend beyond ripretinib time some like other GIST. in our through to now

clinical pocket for is the our CSFXR. XXXX was orally of CSFXR highly to First label over patients tenosynovial human the to other greater XXX a approximately over administered, currently study than CSFXR with and for evaluated and DCC-XXXX kinases open bind XXX solid XXXX selective selectivity CSFX closely related with advanced cell has greater X and a being CSFXR TGCT. inhibitor in multi-center selectivity designed including tumors in or even selectively an receptor or patients tumors switch fold has kinases. potent is giant Phase

with Our initial is on TGCT. focus XXXX

need bursa has genetic XXXX TGCT patients. approved potential fulfill over-production and We was for to small to subject aggressive or that driven is synovial, TGCT for CSFXR. systemic the a sheath significant the a disease more for a hepatotoxicity. tumor medical profile mutation tumor cells a certain of the to only CSFXR, which the REMS is pexidartinib, inhibitor tendon by CSF-X, in approved is effective favorable August due This for in The the an within with that patients. treatment of unmet molecule morbidity causing locally is program ligand believe therapy a has safety

treatment-emergent meeting, nausea. for We oncology we TGCT. advanced I events. of Phase tissue in initial look to evaluation an no forward or society and lipase, CTOS an at presenting four The X increase CDXXX the colitis. events and There and amylase, we The events adverse determine an to positive associated occurred in increase were small or exposure group in ongoing well-tolerated a in seven that patients, adverse IL Phase four across levels, from Japan. to tolerated XXXX recommended dose preliminary XX reached data Tokyo, diarrhea not the Grade is solid generally has or maximum a tumor. in increase dose patients Last in for demonstrated serious data presented CDXX in positive events were plasma, rapid for those sustained of equal than been proportional and blood advanced grade fatigue, and decreases one and most of XXXX two. week X with adverse macrophages malignancies. common Phase XX% or solid triple greater the an most in reduction monocytes XX were adverse were with at treatment-related Meeting tumors connective in substantial related have Annual escalation in Dose the cohorts related XXXX increase Currently, upcoming three was treatment which patients and data dose peripheral CSF-X XXXX. TGCT from AST,

kinase from in Xb tumor an Turning potent milligram Phase from pharmacokinetics. safety, patients are higher being the type in mean TEMs patients, and BID TEMs. Phase to indicating with with patients rebastinib, or circulating Phase meeting and XXX X TIEX to rebastinib Xb evaluated Data including study paclitaxel now milligram invasiveness, with is levels is the metastasis small our was carboplatin. designed advanced X angiopoietin-X given designed and XX X combination and of with angiogenesis, from metastatic Exposure molecule study multicenter XX rebastinib inhibit and of immuno-tolerance. evaluate currently of increased in the proportional in XX Xb The with XX which was the combination also BID expressing study, reported study patients to cohort enrolled macrophages X triple and the Rebastinib in known tolerability the inhibition. to two the tumors promote study open the in paclitaxel doses rebastinib label combination paclitaxel that and combination cohort. to rebastinib exposure dose Part solid and to

responses in prior was heavily Confirmed data Importantly, receive with anti-tumor therapies encouraging pre-treated dose X.X. patient responses seen median the patients milligram more had were two both the with breast, the were paclitaxel patients docetaxel. patients, Phase cohort. and population, three paclitaxel. three Seven exposure treatments unconfirmed therapy three responding and BID eight X including the were of seeing prior responses of and two one cohort in peritoneal XX and carcinosarcoma in eight or milligram prior these mesothelioma; patients to cohorts, number the preliminary across demonstrated activity BID of Most these prior XXX including in dose ovarian, objective than with five

with is cohorts. Rebastinib two-Stage two Most between with well rebastinib the and study triple-negative in paclitaxel and combination were associated first-in-human with the in be Part dose are a generally cancer, tolerated cancer, breast expansion to treatment-emergent paclitaxel similar treatment-emergent with frequency breast is cohorts endometrial ovarian this inflammatory cancer events was study four with consistent Design Simon known two ongoing adverse cancer. treatment. adverse the of events of of

recommended of XX activity of BID, look signs So early in are additional study Phase dose milligrams and the forward future. to by X providing in we encouraged updates the the

Preclinical addition provides meeting of last pathway. is studies mediates shown selective mutant autophagy activation cellular earlier up-regulated by and the designed the small is to tight-binding potent, be selectively Subject and with to resistance of cancers. inhibitors. of has kinase. molecule RAS ULK XXXX inhibiting the expected Nab Finally, presented to ULKX cancers potential a signaling and of new application year, a middle treatment inhibit IND DCC-XXXX potential submission that mutant with an mutant investigational and kinases this announced we drug submission first-in-class autophagy enabling initiates the pipeline. XXXX, data This of RAS kinase targeting for pathway the are and RAS autophagy X in showed the Autophagy that by in kinases. XXXX develop week inhibitor family combination for approach been XXXX potential favorable to triple at targeted RAS to and selective intend in the to our in cancers that we inhibitors of is

development. paradigm pipeline are molecules various we have across of we summary, to of have In stages potentially an say, to spanning excited extensive shifting

proud treatment well other we've made as the XXXX, are opportunities ripretinib, focused programs yet progress remain at of with we with discovery that NDA XXXX, on advanced near expected GIST. the submission of the we we disclosed. for We as rebastinib have had as and While not the

financial turn I results the this to will the quarter. to over call review now from Tucker

Thanks, Matt.

from take our testament XXXX highlights quarter discuss results. third to Let me a few financial

public following approximately First, a and inhibitors. development expected completed the very line control pipeline top our raised follow-on transition expanding fund the switch August, proceeds, a we of of net help will in novel successful million company support which our $XXX results to of positive INVICTUS, money commercial in that continued offering us

equivalents capex total of fund In of the second public and approximately million, net securities, administrative which we of quarter million, our as into the With expect sufficient XXXX. increase the proceeds $XX.X to the expenses Research our XX, were XXXX, cash marketable XXXX. operations million operating be quarter. September of $XX.X $XXX quarter development offering, in from XXXX, had million third cash, expenses and requirements we million were the and of were an expenses third and $XX.X and $XX general will

to commercial as expenses organization continue our quarters expand over expect and coming to clinical our we the We continue to development activities. build our grow

call the to Steve. turn now I'll that, back With over

to the these we're programs forward look study opening We with for NDA our preparing in rapid to now year imatinib. over with into of on the Tucker. of the track GIST treatment we received significant and the to pipeline are first remain is exciting ripretinib company the submit advancing forward meaningful The drive and you, view Thank in and year made for across pipeline ahead. site and have quarter treatment and our INTRIGUE year and GIST to will across rest stage additional continue next we months, comparing patients of and last progress enrollment clinical patients patient advanced for coming updates with the be an providing few prior sunitinib who what We where the ripretinib with ahead.

amazing here physicians thank making patients. dedication and Before their difference questions, their hard clinical call the to Deciphera our and for participated opening team trials a who have for at to and the work in the caregivers, patients, like the for I'd

With that questions. to operator, I'd call like open for the

Instructions]. [Operator

JPMorgan. Your of first the from line from comes question Jessica Fye

is line Your open.

- Hey the are are? you first, gating side taking remaining help would for a help that that magnitude R&D afternoon, think think kind do deliverables growth, can you Tucker, you grow, couple, I the that for ripretinib thanks its had guys, if for can mentioned there about second a my us think talk what then had of us you of we to good factoring - you assuming and and And are most driven? of about so, I'm project can continue OpEx questions. the on of they how about filing any

Hi, Jess, There one lot asked. question modules, that it's part Steve. over the across then the to the every ongoing of across CMC. address a to is including turn NDA each prepare work of I'll of as take the and Tucker and other question first we company for and that's really you the really the it

not would the is QX a gating that I would team call stick that there modules preparing the filing is that work item out really to across they specific So CMC, of anything out in XXXX. is for on all as go of

Tucker. this Jess, is hey, So,

On the entry, ramping the as say a is financial completion side as third is quarter INVICTUS. what well obviously the on than included which INVICTUS, study of larger up that the both I

So paclitaxel in part two particularly into and so assets, the next one of the particularly over, through will XXXX, and well as few move the rebastinib have as continued those those and costs clinical carboplatin. an we part XXXX carry into increased entry pipeline expenses as development combination rebastinib of quarters studies other with the will

spend So the you're that on of the will be going a right forward R&D side. lot increase in

hit side, ready are of be having hiring infrastructure, of addition, meet sales sales at up but the those we'll scaling requirements commercial so time. force judicious In and the commercial terms on G&A will and in to a we force potential appropriate the

open the those And therapy? lines the three for have seen about on many prior Expanded any you Access therapies seen prior of or patients in one then of if plan just who Okay, just talk I'm that to last Program. wondering be have you Access? can number GIST centers how great. Expanded who And to a Will include

the question Yes, the for thanks, EAP. on Jess,

to we're So excited get that open.

XXX we're So have we for. globally we'll expect patients that’s on over planning what that that EAP,

of sites - would would in EAP. US, sites, and globally In in that range terms XX the XX in participate that planning countries of the XX expect we different over somewhere we're on around

therapies. for prior eligibility or advanced received have to terms In at patients need approved a prior of course two unresectable of locally the metastatic and FDA GIST least with have treatment EAP,

Chris question next of from Your line the comes Jaffray. from Raymond Piper

line Your open. is

Hey, from questions the of clarify Designation Question just Breakthrough question. answered last to just ripretinib. the you I for on wanted just status one thanks. about, on

So I submission. to think think you're modules heard of submit at last time. time you doing o, a I option going it, that there rolling heard you I say, guys talking about Steve, an for I was the all same

we should So to regular submission? going you're do a it assume that; will be not that

So thanks question. for the

an So color which the you're a with we year submission of option right around that. not Fast guidance, providing additional Track are earlier disclosed provided on initiating that with the call today, in our rolling us and we're so any designation, changing

the possible for as in one file work XXXX. now our and get as with file expeditiously will ripretinib Therapy completed that the quarter Breakthrough in We to FDA, have we would with Designation guidance remains that of

Okay.

submission. correct? could still Is a be it So rolling that

would detail whether a or be in Yes, not rolling terms any rolling providing it a submission not we're submission. further of

Got it.

enrollment a terms but curious, pushed if of got any kind then from that's pretty second-line any dynamics, have to mean know you COMPASS it's curious on perhaps should respect assume just in meaningfully; you that I'm of just feedback. study, early that avapritinib was I And your there? potential early competitor, learned feedback the Okay. enrolling I of when back got physicians dynamics sort plus early with days, just so just but recently trial your INTRIGUE we

Yes.

been INTRIGUE So running. of with we've pace pleased up the getting really and

competitive looks had it haven't we now, foreseeable you won't a dynamic and like pointed as the we know, you have trial trial up for As until any future. out, competitive

enrolling countries XXX we how the and sites expect As the now pace for patients XX in also pleased XX we to mentioned that of pace really opening and have open with sites on the remarks, the active we're over study. Matt, both sites of study, open, in we're we're prepared

that expect will INVICTUS the that very as of considerable patients, and based the there this released for that plus that pace and setting enrollment study amount going tell you early year, enthusiasm is we've the would now would that for as the that data by ahead a a setting. meaningfully option in of out results. little least for and both we getting anyway and you second-line of generating to the fourth-line, and fact of study second on reporting Blueprint It's to in about August sailing we into As that This us in like, a investigators enrolled, we ahead fourth-line expect positive were results point the they is virtue well translate have view in in line what look study INTRIGUE smooth is believe an then enthusiasm second-line won't but study. still fact at of the as getting data a our as of up terms thinking

Your question line Guggenheim from Schmidt of Michael comes Securities. from the next

open. Your line is

Hey this Zhu Charles on progress. Thanks and for Michael the for the all congrats taking on Schmidt. guys, is questions

see for of INTRIGUE's to well different and OS coming OS ripretinib which assessment given accessing as INVICTUS, up I'm off-trial INTRIGUE, the Sutent wondering crossover or one that complication degree commercial therapy? the the so plans as a patients of with First endpoint could ORR I clinicaltrials.gov effectively and for later is as that PFS secondary, primary on by is similar than on potential lines in

it's Hi, which Steve, good is Charles, the a question, Yes. thanks one. for

patients second the line You're the we'll in data in and benefit. the data line setting which enrolling study, We is the in generating right, not therapies endpoint. currently forward study you're be the in that it right setting they're demonstrate think would And then a an PFS course, overall subsequent in getting It's we setting. But I also study and that the available. for approved ripretinib that survival when primary nonetheless, report in given of suggesting allow crossover given therapy certainly a OS of an second the study. secondary there is availability look on the endpoint to is challenging

me wrong, great. And mind, on successful if also with explicitly just but allow dose INTRIGUE for upon INTRIGUE but feel about you'll I study the INTRIGUE as might I'm doesn't does BID is escalation physicians And line? in as, correct I from assuming potential it, that think not in Okay, escalation dose progression. how have in line for second INVICTUS given data well X kind it in guess fourth of Phase

Yes. Thanks, Charles for the question on dose escalation.

right and triple in in X escalation that the provided was you're his early second line data terms or analysis the with in potential fourth and might for still patients. approved, the the want at be It's the So Phase remarks described study you're also our of Matt whether we Boston might those and days to data update it's INVICTUS just be week of where the prepared for dose allowed meeting the course for the familiar help of it'd setting in physicians this us ultimately setting. line what in last drug, implication in assuming use

line for the I development in that beginning this highly is with this in a really GIST setting. the drug So active Clearly, think of journey drug just product. us fourth

does of therapy in the the prolonged the escalation this will challenge and fourth at Phase for us patients. a for lines third the clinical what also across dose second, and going I those and meaning for drug benefit line highly study think is think what demonstrated setting to active clearly be drug community how I and is dose forward determine X going ahead to and shows

I in We our of coming the think expand will to ahead in the this sort have GIST. use understanding through as of to that we drug years continue

one view in from line you've your potential ripretinib the has your All KOLs, in right. well if the for a of line such view especially And received on What's investigators, escalated. GIST if feedback patient fourth it any from potential earlier as It already dose as - weren't rechallenge makes previously patient last sense. me. gotten your

outside the in suppose these inhibitory not I and all physicians rechallenge addressing disease. question. that imatinib And path GIST a relevant realm of may data mutations it's of certainly the that upon patients to this explore of In ripretinib kind an with the with the - retreatment. potential with to profile for course benefit or Charles. able setting generate are of similar ripretinib the Yes. Good rechallenge spectrum we familiar of really path given a Thanks, similar as quite pursue to of but this example. drive drug possibility be used the and broad pursue

still understand of course need sort in see context offer. data might that We to drug the of and better generate what benefit that

you we it related there point future early, little bit to retreatment in of So still to this is and initial out. whether this as drug explore to a us be disease the said for opportunity as developing I think whether or this it view and as set steps certainly we are related be escalation dose

comes of Jefferies. Yang Your next Eun the line from question from

open. is line Your

second-line Thank you. for GIST ripretinib. Question on

of papers shown you which X about weeks ripretinib. Phase is show XX still XX for PFS the some recently what Sutent other XX but weeks, show PFS published about of than So weeks, lower have

assumptions sunitinib in for X ask Phase powering your INTRIGUE? you when So what a I

Eun, Yes, Steve, I'll that it's thanks, question. take

couple one what lot in sunitinib have of course to contemporary setting. years, is disease survival over of spent expect progression-free line we expert of So a the the thought a second and of understand working might and in in of with review understand time leaders how the field terms last treated to the

we've there label, FDA studies approved course for as which experts of in out We that of and different weeks to what's weeks the in you one You're mark, is what very sunitinib, have so is the second XX consistent Sutent label terms PFS and that course PFS this the and some feedback this the explored that of line and point right. discuss the there XX expect often treat smaller would topic the referenced, with still is rates the are the we've disease. yes, the of to disease, setting that with received relevant in also

in meeting a disclosure which where the last setting. the course in ripretinib PFS in of Boston, Phase a XX an now showed actually which noted, X, data is line also improvement of last the week with - we that improvement second cohort weeks, over triple updated the You've at patients, we substantial

we've So INTRIGUE remained study. for our powering the and very confident the design in underlying

what As forward this are enroll have then reported don't can looking with that assumptions generate I powering we've and and the time set any to out I at I we to continuing data generated, data beyond share additional noted that you have earlier, to once we already of but patients disclosed.

TGCT. of that would so to XX%. it the Okay. there that patients response data, able - a number And then you XXXX, study shown comparable what to in In could rate see [indiscernible] with be [indiscernible] be

Yes, for question the on thanks, XXXX. Eun

point was So, as meeting Phase week out, population. at triple you last X tumor patient in the the the reported solid what we

we're with at week, which cell already CTOS meeting, so number the looking reporting in for And coming tumor. time patients giant Tokyo, in we'll XXXX next Oncology Tissue be Society the Meeting, Connective forward small tenosynovial with data is the first up of a

in that's forward course data can XXXX. course enrolling initial so you more additional that would who complete that small in yes, set course to that data number the patients. response dataset for safety, more who a But point for but evaluable are patients is open report include cohort study with next XXXX this and efficacy. hope patients of just be to an even on expansion will generating look of that And evaluable patients the for data included we full over of out week look are evaluable forward out in of we also I'll patients

Okay. Last on is rebastinib. question

at response kind showed no-go mind So rate any XX the X milligram but go- decision is about in there recommended at the program? you for of meeting triple have rate determine that could Phase you that dose, response XX% BID

Yes.

we he decision So for cohorts cohorts we do have met. are four expansion certainly the expansion can the what enrolling on outline turn for are that rebastinib, it those that last is will the provide additional to cohorts those criteria these week, have some Matt, certain then we assuming expansion further and expansion we that we in make maybe presented color of posture and I'll and

Yes.

question. the for thanks again, So

be if will as it's XX will different the breast the will numbers and the is the it's to of in ovarian design and patients, expansion patients and based triple-negative the populations, into the we XX first group mentioned I cancer breast on endometrial than into up indications. in we Two-Stage inflammatory be we enrolling indicated, those the those of cancer, two where group forward we Simon patients, four Two-Stage cancer roll moving rate part study as Simon a for the with those cancer, more in of cohorts response move patient four and Design, and estimate responses four XX there so have to second a point in stage that then of So,

Okay.

with by to signs the we're more and to And forward that populations I early expansion certainly would data more generating encouraged efficacy homogeneous of to. patient look combination those add cohorts that, the and Matt in referred

helpful. you. Thank That's

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

line is Your open.

more about you curious question. my Did Hi, Christopher. this was some can XXXX, just as have anything far pexidartinib common for Jackson elevations. I with color Harvey for the tell? Thanks around AST is they in on you as could provide taking

Steve. it's, turn Thanks it And Matt elevations. for to the AST question Jackson. that. on Yes. in XXXX address over to I'll

of as the enzyme, can the that's of particularly noted, question. again And part enzymes the be see so one due thanks Jackson, clearance against and these can elevations due ALT this the for to in in agents, targeted certain decreased elevated the to CSF-X liver nature the and Hi. with of receptor. within products so class you liver of AST

to Now, well across program of enzymes liver pexidartinib's was those Phase their in too. their elevations X case, number in a who there to ENLIVEN that study in having [indiscernible] hepatotoxicity on function was addition as reported went patients in of

of be a liver of that test. toxicity the different So type beyond may represents benign elevations function

Great. And you about you Got it. anticipate possible do to registration studies pexidartinib? with as do studies, head-to-head think having

that to for comment single-arm might generating Too design versus whether we study, to placebo early we a thanks, further forward presenting past what us a a a be still a study pexidartinib, it could look exactly on us the be, to little then versus be, for future head-to-head need Jackson head-to-head not the us data or and week with a study Yes, It's early clear might and TGCT. be development data versus study for tell the patients randomized would ENLIVEN pex. do really to whether like it of to the question. what to could next but registration additional

question line Your comes the from from next JMP Securities. of Reni Benjamin

line open. is Your

anticipate about thanks initiating beyond Hey, strategy you all the progress. guys talk an ISM you your I a and GIST, cohort do for the taking the little can we the SM, for on are And questions bit when guess, from related that, trial, to you how I there. an ripretinib? cell cohorts non-small update see SM the and of of making gliomas congrats might guess lung decisions

Steve. Thanks on question SM and Reni, Hi, for It's Yes. the specifically.

progress during been and know, study. expect have XXXX to cohort, the we've an of evaluate think they've for a of this the be therapy at on as and mass expansion good period frank, It's in been for is response. once enrolled to working not critical recently data you we to enroll. not cohort expansion the us the some update easiest We to been time Phase really cohort made an hard course we on study to patients we've of hope for X have patients and and was So, necessary would get a

like. might we we So a look look or for what path data further have those don't at generate until guidance in development any further XXXX, comment this time, data on

any in have you is ripretinib, thoughts of work overlapping, Got GIST, just it side regarding are it. might should it thoughts regarding out but combinations mechanistically that perfectly, sort And effect studies seems then just maybe that forward. your regarding what going profile like the

thanks, Yes, Reni.

recall that ripretinib the of fact BID this as in who have dose patients an therapies, that well X number So about as the combination in for drug And Phase talked well. to appears we MTD we be in context we tolerated in of XXX never escalated the thinking to study. very with and mg reached specifically call, drug about earlier on a

exploring So what we may to that or think therapeutic that's on potential think monotherapy partner our that is explore drug is seeing committed combinations this those going good optimally different to has it's this and what that of we whether of potential be may in and as we're certainly whether and agents, I fact therapy a in to of and with and be combination, across this that well something very patients in ripretinib the and good the beginning is lengthy uniquely targeted other so or journey index of be able and but to not tumor radar. might different positioned how be role treatment drug about agent combination look non-targeted types, most this of as as other the avenues for time a really a agents potentially talk GIST ready we variety all a benefit referenced productive we're lines at like, an earlier settings.

final where big you of approval one just you in as and the sales just commercial of be us right you selling on Great will can your and be, it start get latest ready thoughts you hiring regarding kind now give the to force, one, soon kind how process? are as should

Yes.

thrilled across to organization to experience the of them experience, to folks of that the field really strategy of to organization. been the are been Deciphera organization. have doing all of finalize launching think These deep a affairs the attract team. go-to-market work team specifically the and that We're sales is what many we've So pleased quality have market our able the commercial going medical roles a deep the in and for the be we've lot with oral oncology fill oncolytics US so and through with we're now to right really

we of have might trained you has and MSL out somewhere about would number of sales the XX that and to prepared team affairs the folks we expect range, would specifically And for to GIST, medical that in so final US already see in be the XX me what range MSL on the organization group absolute the and physicians disease. give again management about filled be. and it the a premature now the disease of the comment fantastic a representatives to side, entire on we team in absolutely with I speaking can have and

we're make we're power group who of go, so in So the to I've application all to my broader get everything as ready this sure to the on and that approval when really are year committed for our ready next in are team right is drug to patients people in prepared remarks doing the acts have that working a of hired and trained approval, need the all we potential prepared, functions to hard assuming across to FDA and the mentioned it. out and

[Operator Instructions].

from next from comes line Jones of Roy Soumit the Your question Trading.

is Mr. open. line open. Roy, is line Your your

the maybe had caller Okay. away. go next step maybe mute Operator, or we unless on should to Soumit to is

moment. you. One Thank

Lee Your next question comes from Arlinda Canaccord. the of line from

Your line is open.

data might Thank efficacy? you taking if guys, PDGFR able and been give a Hi from Designation. GIST I study any to Breakthrough congrats for glean questions the might question to my about have the you patients that thanks read and the you. on from that the through had any

to patients offers, Thanks INVICTUS to for Steve. specifically you PDGFR the study? it's the question. With the are in respect Linda, Yes, the referring

Yes.

think PDGFR enrolled, I few at really patients Yes, we none demographics, patient had we it so in a placebo them handful a the the looking had and arm. only handful, as three of you alpha know, ripretinib arm patients relatively the was and

So those real we that don't have can conclusions from draw any we data.

or yet really data out so haven't us offer broken subgroup, We help by guidance. any doesn't

I think the data will key in SM, specific to question generating with respect population. be that

and enrolling noted those As committed cohort generating I the data XXXX. data in that presenting we're earlier, to and

then data let tuned get we presenting say those us at patients patients in year. next some to generate look on and SM, some on So forward study stay I'd

sir. Please ahead, I like to questions this turn at President and CEO. conference no showing time, the to now I'm go Hoerter, Steve back would

afternoon. joining forward and I'd have you and to close therapy great We're XXXX the to call. the looking Thank today Great, this thanks. exciting preparing like our support. and in continued launch thank your year a additional ripretinib. an first us year our for for then pipeline for potentially of and all you generating of data from on Thanks to the interest

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

disconnect. all may You