DCPH - Earnings call transcript Q3 2021 | Deciphera Pharmaceuticals Inc

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Operator

Good afternoon, everyone, and welcome to the Deciphera Pharmaceuticals Third Quarter 2021 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 of Investor Relations. Jen?

Jen Robinson

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

facts would statements that clinical Harbor pursuant begin, of I of our like and QINLOCK forward-looking historical we and Securities forward-looking Private are call commercialization Litigation on XXXX we you expectations Examples during XXXX any to the Before guidance. that to reflecting made call make of this and not and this conference current XXXX. for are Provisions statements remind programs, of statements expectations the beliefs include Safe of Reform the our made management, Act preclinical our

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

call company’s Following will the made Steve www.deciphera.com. to site, Web the Deciphera. that, President this Steve? With Officer replay will and on of a turn over call, available Chief Hoerter, I now be Executive

Steve Hoerter

good everyone. afternoon, Thank and you, Jen,

world a benefit reach treatment far, data the In on for we setting. the announce approval have patients CHMP, the continental in Based U.S., candidates up to of and marks INTRIGUE the through Europe. totality received the GIST, reach September, we in positive line with QINLOCK. U.S., study two prepare the that from In our QINLOCK rapidly the our worldwide broaden in strong to QINLOCK standard expanding X we made the for EU of approval new INVICTUS our by quarter, priorities, were and the providing care and ESMO, this to Outside third in This Phase disease. also potential against studies. QINLOCK registration results confident first approval QINLOCK of pleased of this GIST the X and moving this later opinion with fourth-line study including quarter. we geographic advancing In for Swissmedic, product of work data the agency. from Switzerland's transform we important GIST the of EMA’s GIST approval we the we tripled for for fourth-line directed as next updates the QINLOCK survival have this pipeline During QINLOCK providing top we long-term Phase the report quarter. clear patients the the regulatory the later showing established expect overall QINLOCK toward At we a so seventh remain from follow strategic in October, nearly fundamentally clinical around the for generated we of progress both significant to second-line in foundation as QINLOCK presented continue

option. new important need in to patients We a are medicine for of are excited bring in to who this treatment Europe designed GIST specifically new

received Officer look this year. quarter. approval Taiwan disease Zai in on its to of in launch each with Beyond QINLOCK GIST in Kong, our diagnosed forward estimated recent and regulatory with patients for XX,XXX provide partner, fourth-line working to where China market, Zai execute on approvals highly were Lab, Building excited new will We today's last are GIST provided We on ESMO candidates. QINLOCK X Europe, Hong to throughout encouraging September. the continues updates in product these patients for in new the Phase an to disclose vimseltinib to China Chief data Zai Later forward these move studies with plans the for rebastinib Medical China. pivotal review meeting and Matt the at our present Greater QINLOCK data to call, our we and novel Sherman, updates

registration giant year. CSFX For TIEX And with MOTION this we vimseltinib, potential first-in-class in rebastinib, initiate our the potential study best-in-class quarter. inhibitor, expect expect receptor to to patients for initiate inhibitor, Phase our X study tumor a next tenosynovial we cell

In to the important leaders research. inhibitor is are cancer in study to DCC-XXXX portion triple year. from with dose autophagy clinic new we of the in targeting the in DCC-XXXX exciting area this X combination and initiated Phase ULK EGFR In and We with meeting, highlighted we our the October, this data present in June, cancer next at data first the inhibitors. enter of escalation expect preclinical we of study XXXX

Officer spectrum broad cancer a malignancies. I'll preclinical and discuss the DCC-XXXX upregulation QINLOCK the combined the turn of call models with the the the solid non-small mutant Dan Martin, non-small autophagy underscore potential be vimseltinib, the in from cell vimseltinib. These to lung commercial cancer with first for described targeting for with and care Commercial of to current anti-tumor Chief For number the cell and cancer of of in and we literature of QX. time, agents combination growing to across standard results significant now and our lung targeted data applicability DCC-XXXX over EGFR a seen of the hematological Dan? synergies autophagy the

Dan Martin

as of the in of ahead strengthening you, we million payer QINLOCK to The fourth-line including persistency. net further we its in standard larger for Steve. the and new goals we XX.X GIST patient into foundation have QX, planned demand revenue including total of launch QX, consistent, U.S. and In commercial second-line acquisition, setting. achieved million remained significantly the XX established core drivers excellent access product globally, In in Thank execute our continue care position our reinforcing QINLOCK, the

positive since of this by most During perceptions to XXX execution increased growth the quarter, prescriber prescribers from of coming with key QINLOCK. performance physician again Other demonstrated strong our community setting. and footprint we approximately the launch, again commercial nearly metrics XX%

As within earnings to higher in prescriber high D call, product and Consistent due QINLOCK of prior assistance PAP, voice to drug awareness, access. our Medicare for share during gave the safety, XX% our patient patient reach, we ease and achieved slightly of patient percentage and our patients guidance estimated population. efficacy affordability receiving under of free was XX% Part our convenience of with high program, marks prescribers and range levels again or challenges the increased QX quarters, than

and our the projected annual line significantly we QX, to adjustment XX%. Additionally, with as average consistent, was in expected, to the in of expect QX of the increased percentage QX gross to and drivers gross net in PAP QX. expect net demand adjustment be line remain we QINLOCK versus In with core

at a believe XXX GIST than second-line Since their to has have almost experience in care our Matt. the launch, and prescribed GIST have expect gain new treaters X,XXX line reached potential over agents. survey, turn where market who work also to recent standard clinical team important to QINLOCK from to to of market hard launch, establish perceptions to based preparing who will medicine. of we Recent the all now we a ahead, even helping in setting treaters product In the in access the research is higher QINLOCK, community earlier been very with two research potential more for a QINLOCK experience rated has additional the We treaters already on GIST are benefit forward across this second-line positive sunitinib patients. have addition look product established. and the we Looking approximately we setting I physicians, encouraging. call mostly the tested attributes patients

Matt Sherman

our Dan. tremendous pipeline stage programs. share have I'm progress clinical in encouraging we you, and each made Thank We've the year, results this pleased our to advancing of

develop Importantly, new towards deliver important to the treatment we're our working discover, patients for mission of to cancer. medicines and

are development global We advancing rapidly programs forward. our

QINLOCK QINLOCK with in I'd X comparing to Phase GIST. study in INTRIGUE First, with start to sunitinib the patients second-line like

in likelihood top quarter success We expect this this remain study. of in pivotal confident the results report to and line

We forward next best-in-class of excited to vimseltinib, our are potential program move our with pivotal also inhibitor development CSFXR.

expect the XX with resection. will Phase In TGCT study, or X X in eligible patients the in symptomatic surgical X a we of double weekly blind randomized patients study, to be approximately first placebo patient study to treat for controlled quarter, non-amenable placebo weeks. vimseltinib global the XX either MOTION the randomized receive for milligrams This period to twice

patients this TGCT thought Interestingly, vimseltinib objective team of is during an patients program pexidartinib, off is to rate a their of response XX, inhibitor, listed NCCN continue treat low week to have CSFXR label or study great for approved to To showed a from in and imatinib Guidelines on a a label study. target black may be is fatal event evaluation a of that approved the running I'm vimseltinib so treatment the this response getting or box Imatinib only has need using most disease. up the which extremely the based for this best-in-class and for retrospective in will rate. there was indication period proud of REMS subject and crossover the data to weak is option and primary quickly. to that an unmet [ph] open limited not hepatotoxicity, which the our is Following adverse endpoint these for off effect. potentially a are a medical pivotal TGCT new product option There's date, patients. one study offer

encouraging we from drugs TGCT escalation are designation with up. symptomatic We patients designation for regulatory was A tolerated TGCT, are from We or year. excited study. patients well to ESMO forward to the to announce CSFXR study a and important recently in to preliminary X presented today the MOTION FDA expansion in Track X/X looking X the are of across not grade review. data from from safety we based need of early, still Phase and follow cohorts the surgery. on cohort received and and The and study this XX% of for without cohort all exciting XX% Phase the is patients efficacy designed is [indiscernible] Fast expedite patients this two response generally amenable faster, were with have we of at treatment of dose majority with development lower. get greater portion the who Treatment of to is the vimseltinib results exposure facilitate the vimseltinib The help the or A study vimseltinib to This was designed reported longer rate portion Phase in that treatment intended objective

rebastinib, pivotal study X for Phase in other or TIEX Planning inhibitor. stage ovarian a to turning ongoing potential PROC. of our best-in-class cancer, program Now our clinical rebastinib late is platinum-resistant

authorities median health The Earlier study we presented from demonstrated We year heavily pretreated this the at Phase paclitaxel expect [ph]. ongoing study initiate from combination to feedback progression with combination data in the patients. rebastinib promising PROC this next survival following ESMO X.X free of months. exciting preliminary year, in Xb/X of

patient EU recently opinion generally objective the potential unconfirmed objective response the treatment the was on addition, Based XX%. in be In is cancer rate agent and the expected adverse emergent two. to rate to on ovarian confirmed single that positive published of literature, be XX%. grade unmet survival We the is Designation underscoring the most also progression issued and objective Orphan three was EMA to four address. well XX% treatment response Drug to free significant received the months, by expected of rate one rebastinib events was tolerated, XX% paclitaxel has median to combination its the response The and based confirmed or the need while were for

of generation combination that are next cell autophagy an one types agents In in factor candidates lines. anti-cancer a continued in mechanisms ago. caused The At the generate EGFR that evidence we preclinical key very directly excited to recycle treatment triple XXXX we DCC-XXXX, important components the cell pathway, plague about on with cancer in of that then cells a mechanism presented many growing addition upregulated treatments. of first-in-class in a entered survival cells that provide to novel in of At cancer to stage kinase with we our clinical and lung substantial the new body escape role damage anti-cancer a to autophagy cancer. in preclinical osimertinib led the lung demonstrating with few a is synergy have Deciphera, by of kinase evidence ULK addition afatinib addressing our may approach mechanism cancer data models. meeting, inhibitor in inhibitors our development in by in late EGFR recent XXXX treatment by generate ULK programs, which There's autophagy vitro months In initiating autophagy, after product that variety stress cancer data energy. inhibitors, And of showing to reduce of develops of non-small resistance autophagy is therapy. showed the

the to of resistant combination In LKBX inhibition significantly in treatment. a kinase Nature published cell addition, is that demonstrated model mutation, the can strong checkpoint which lung immune addition to Cancer ULK cancer also with of recently in tumor KRAS of role non-small potential treatment have co-mutated and outside lung a single blocking greater a in in continued the the both Deciphera XXXX of show in When inhibition, responses agent with checkpoint be autophagy. study after for the case malignancies. resensitized inhibitors an solid vivo resulted hematological with data in they to PDX EGFR to are compared in frequently add xenograft autophagy Researchers cancer that

show Science of Another a inhibitor recent study in growth. manner Translational cell with treatment an CML in decreased lines the Medicine [ph] autophagy

KRAS co-treatment including to ULK the stem cancer Once our again, field the and supporting potential ERK, drive of cells, in combination the and checkpoint range and as inhibitors, preclinical PDX, VPSXX These contributions addition, program, Deciphera of leukemic patient treatments, of leadership persistent a MEK, PDLX for in future. support adding cancer including relapse. wide to inhibitors, In with evidence kinase role autophagy TKI kinase well and resistance other patients additional to cancer, RAF near provide the strategies as in data eliminated positions cancers. make DCC-XXXX significant breadth the which GXXC direct

pursuing year. standard studies combinations like and drugs actively therapies variety cancer are and mechanisms, with to these care on next of forward acting of further preclinical reporting We of XXXX look a novel

is phase RAS/RAF for treatment of in pharmacodynamics. year, the go-forward this of the XXXX ongoing quarter dose X multiple Our for of dose first Phase area from single phase development is Enrolling vimseltinib with the a focus clinical solid expansion mutated the XXXX an this with study for escalation of The second phase. study parts, tumors escalation and and including in phase inhibitor. next of the in year. types. the from combination for started MEK dose pharmacokinetics [ph] escalation safety, also provide XXXX, will important forward combination to of agent study in with will tolerability, Data will in We tumor expansion dose and the used the phase data data phase determine be look presenting two

across Tucker? believe encouraged cancer. We the treatment patients results. the our over are of our Officer the I programs will difference in the Financial meaningful progress Kelly, will now of Tucker review innovative turn strongly these financial by that call a to to each and Chief with make

Tucker Kelly

have million September and Net cost Thanks, the ex-U.S. product Lab in financial for million third million, of for XXXX of sales net with quarter of XX%. efforts. at full was sales Greater for a sales Matt. sold include XX net adjustment with QINLOCK. months Collaboration sales Zai inventories The third revenues the in that of I'd quarter in sales of revenue QINLOCK increase million million net cost revenues and supply product royalty view the X.X product X.X the commenced sales expect in X.X of will zero with after like included million. quarter estimate includes of the gross was all million, which our the XX, revenue collaboration QINLOCK and from net line XXXX our our in the agreement sales China. U.S. QINLOCK to the of and highlights which X.X in quarter reflect XX.X cost revenue which third significantly of of quarter of not includes three X.X XX.X QINLOCK will of as to ended results. under percentage QINLOCK third Cost product cost which inventories of million, we product was do We in was revenue Total manufacturing. for cost

the in inventories third compared million million U.S. and in XXXX. million of compared XX.X the of operating compared same XXX the QINLOCK We in sell XX.X this in same XX.X quarter XXXX. of Selling, period in expect XX.X Research Total expenses to expenses during in the general to continue and XXXX period year quarter development were the third were into to total operating million million in cost quarter with in to zero the to and expenses remainder expenses million the XXXX. the same third administrative XXXX. in XX.X period in to

our continue ended in in strong of that our operating the million, we and position commercialization we first on We as cash, equivalents invest fund in turn commercial with that, sufficient in of the securities to will development the quarter now capitalized We back royalty revenues, launch for clinical our cash Europe. expenses the a expect supply be half expect U.S. and call third approximately prepare over and the the well operations of which With will pipeline, potential with our increase execute product, to marketable QINLOCK financial Steve. and anticipated to XXXX. together XXX I'll of remain into

Steve Hoerter

Thank you, Tucker.

enter the this we've the what I'm accomplished far company. excited of we made about year the last so As across XXXX, progress and quarter we've

We positioned the in QINLOCK INTRIGUE prepare report success X are and well long-term as for Europe from Phase the results launch we to study.

to Operator, updating and we our to like of the best-in-class open call product progress. advance to on our look rest we the future for first-in-class candidates. now of addition, you I'd And continue pipeline In forward Q&A.

Operator

Chris Raymond from our from [Operator Instructions]. first you. comes Piper question Thank And Sandler.

now is open. line Your

Chris Raymond

taking for questions. Hi. Thanks the

here. you about I not talk think there lot indicating were metrics, quarter, that Last a was talk couple I dose commercial on you progression. questions about sure quick heard Dan, escalation heard intra-patient past a was this. of ones, going but some Just I'm you I

that Just asked that are think about guess, published it pick talk that, up? Is I the sort And in especially and of we there since opportunity quickly wondering QINLOCK I dynamic different there's question. is hear option of sort if July. of about It any ASCO? Thanks. the from you care just it's but seeing out of positive that then became standard How talk this penetration another broader you a three assuming between you just Is thinking setting? is in established data sort This I second-line, kind of same? get thinking question, most directionally, was the be had the GIST just at and in data that probably second the quarter? quarters. you of fourth I dynamic should maybe maxing an of could sort the anticipating, and might in to fourth-line how of be really dynamic second-line given about investors velocity Obviously, sort this obviously question

Steve Hoerter

Hi, Chris. It’s Steve.

turn me part of take So to Dan to address then the first that, over the it your question. I'll of other let part and

meaningful PFSX patients, that data generated reference we fraction the view especially the dose both PFSX. as And measured as datasets were see published And heard over clinically feedback the when you to a of our benefit data the really being as look received both course the for study, we X in peer from the as review by of know the from they we've the thought summer months. IPDE certainly literature data you leaders, Phase randomized the from of at patients well manuscripts INVICTUS, you the those as X. as the So as upon data Phase and study, fourth-line that that pleased very from escalation

encouraged really data. we're by So the

Phase remember, study, might didn't the tolerated escalation reach ripretinib, of the in we actually dose study, part up dose you the to a patients we daily. dose XXX with maximum As X and milligrams

even evidence think if we and the drug for remains from been dose certainly dose, INVICTUS data headroom escalation. So higher at from And feel the as by X, no we well have tolerated. ample that's the and that Phase I

want the of Chris' to underscores utilization to by market encouraged question Dan, address what rest product of the in efficacy you're actual with data that interest. about the the the IPDE? we're do So in of seeing you terms respect

Dan Martin

Thanks, questions. absolutely. Chris, the for Sure,

KOLs, as patients. as a So on front, who IPDE has received in particular, well really been really the by the this Steve for the view meaningful said, data benefit

of certainly that, The so interest been is this label an is And dose. there. though challenge off there's course,

not able to promote course, So We we're our promote consistent labeled with of that. only, dose.

in happen. dose. dose we is sort see on labeled And are use, it the but dosing. not. that relatively And payer thus has is at respect with inconsistent. access some We Guidelines the a remains portion overall this. see to doses The of to see equation. that smaller majority the and and so seen thoughts a for that think and what not our of vast to are added it couple dosing far. use are could consistent regimen, if of be of of claims when also provide what not the It is is If others we the marketplace From momentum only the side a And NCCN demand perspective, approved for IPDE which some will been we

reaching to the and we and even underscored continue by prepared belief just the users really as more consistent of but we've pleased tremendous but as about far to And just seen it’s second across in incredibly as support see, community high and we've been that a the we've scores have second not line. the in remarks, with broadly line, that made rapid the been setting. we'll overall thus just I see the your more portion pretty progress our small in plays how QINLOCK yes, So just board, uptake With respect more relatively to fourth out, in uptake in question dosing.

with extremely launch. for really bodes second-line we far. our think progress the planned And it pleased So thus well

those XXX we we where appear. are of be it to As only have patients fourth-line or are indication message And I -- to to mentioned, we've so date. who reached never earlier prescribed an our going course, reached our treaters be line to likely But that we're awareness well. seeing mentioned that sets suggests developed just on the And based the we drugs market prescribers, higher QINLOCK up of future many sunitinib. of remarks, the in us prepared that now broader general potential experience that the fourth-line as because the set that that of you and actually I clear, GIST treaters know we've think physicians extremely beyond physicians to additional research perceptions than X,XXX two patients rate significantly in

of there think we're physician. impact you So and continue certainly that line to the setting more, the continue The think think is to second mentioned, of and reasons, established these as to and much set community will we isn't need a things we be up community more think for earlier that uptake all rapid we We we'll mention reach will that line. only we domain really because the more therapy I'll through, for work possible. of things well course, relatively that is be other that

that be But great opportunity are very we from a for second-line the listed, we those data rapid all is a got launch. at we've So for INTRIGUE. penetration focused reasons things pending will think the on driving

Chris Raymond

Okay. Thank you.

Operator

Fye our comes question from next from JPMorgan. And you. Jessica Thank

line Your now open. is

Jessica Fye

comments the in questions. line So you much top separately, penetration me. community Hi, estimate Good to kind you you how Thanks any, results how steps can my Where reaching following at additional couple And appreciate file? stands this rate soon support evening. point? A talk needed taking be you but physicians, GIST could of those more for about second-line do the about guys. earlier would SG&A, INTRIGUE? your for envision launch? do a And next if fourth-line from

Steve Hoerter

questions. your for Thanks Jess. Steve, It’s

turn. Let's work our try through in and these way

the last as and a as INTRIGUE in will thereafter. prepare terms line, of of next then the here, the So both once shortly INVICTUS turn over the fourth-line of And in to think the well course, penetration of the With market to that. the of SG&A from the step, back terms it And I'll out our what the be to I'll would, to, at to our of investment perspective. subsequent is probably use hope for and to and all filings in would filing U.S. a that timeline the I a for initial talk we With proxy to the filing. make take with Dan good in our a filing experienced And what about top get over we the to of respect and seeing we expect to months. with we we're course, looking U.S. probably be we part in report don't or a plan filing goal bit view respect commercial to Europe. European footprint to additional launch, affairs medical how don't the two increase of those size expect results, little second-line course to course, respect in

patients. right And patients well noted, we're calling fourth-line the Dan We both as already. on as in the community patients GIST physicians already opportunity with who would treat the sized see for second-line are has who as

increase we terms wouldn't So to expect headcount. of in see any

promotional as in dollars penetration to want we second question. the process there'll terms data and do marketing post be investment line start launch that off from Of in Dan, of cover course, you on additional the INTRIGUE.

Dan Martin

Sure, absolutely. Thanks, question. Jess, the for

So signs the surveys. space. do of highly being derive We we to before mentioned any in imperfect share point fourth-line number continue within the I've very to continue to -- data this a all is opportunity. penetrated that

the fourth in standard do out even agent” clearly all us fourth-line a surveys. as getting And their penetrated, very have use called it are continues physicians use accounts, but “must the by we that viewed setting. leverage line. he'd we us it will audit what charts told surveys, fourth-line of the any care physician physician chart recently setting. and pull And in to highly be go as who's surveys, also We'll one in actually So what number and of show

Jessica Fye

little thanks. seems persist now, that then proportion talked quarter? Okay, MOTION running down of drug that range? range take Can through fourth And enroll follow high are trial? back this talked your will project comment a ups? XX% couple a we to on expect Should the you've R&D I who XXXX, to to for come on the and The that about XX% of like true being to it free it about, or one dynamic the patients right same you quarter long how just do add the you to it's question,

Steve Hoerter

then, for questions, take Dan, want MOTION Matt, Thanks the to and percentage that do And you'd to persistency question. question take about Jess. Jess’ and [ph]? this to the you first if like

Dan Martin

you. Thank absolutely. Yes,

Jess. Thanks. good So question,

as we earnings in the mentioned top to QX would slightly XX% expect or in to well. So that QX our XX% above we QX be and at end as then of call, range did on likely And perhaps the the the that on the drug or that program is need if the drug free year. benefit drug way D balance a works remain to calendar is they patient on that a drug for goes Medicare Part reason of through the free program, continue

program So out likely but to you're that the into there wind the dynamic for up a QX, is term know year. where round once have is as the it, for you best sense to that, that seasonality if I don't there you you're is

played guidance it's And been out to exactly we far. So that's we that why anticipated much the thus we've provide as pretty able have.

quarter-to-quarter. we does that gross along -- are estimated vary is very to somewhat it XX% all range -- though, still of think net with the vary the that These year. guidance forward things are XX% to We can over do would Going we the said along, our much does give to it that we've whole expect overall quarter-to-quarter. that as it

Matt Sherman

is Matt. This Jess. Hi,

we the and all the A about at in about planning So rate XX% countries. study in Phase regard escalation response data randomized your both with MOTION the the in our combined recently about presented study, excited showing that question ESMO phase it’d X/X study, MOTION cohorts we're a a the very be XXX expansion patient to XX cohort across

to benchmark, A Part a months in the XX X as of approximately about in we able six Just Phase X/X cohort enroll were the patients study.

rate, world. now really response in opening the high interest about and around the investigators the from multiple the this with So countries up excited

rates. enrollment good enrollment should this We very early expect that be

Jessica Fye

Thank you.

Operator

our Schmidt And question next from comes Guggenheim. you. from Thank Michael

Your line is now open.

Paul Jeng

Paul our Hi. This questions. taking on for Thanks Michael. is from

ahead us a couple from entry Just readout. of the on

mutations? thoughts you. First, color study primary patients any as how exon then QINLOCK in in terms XX, taking share and the a Thank of in potential helpful? you breakdown on on second-line view expected genetic XX of maybe terms population really be your additional secondary of current of would the or And performance follow-on, the

Steve Hoerter

It’s what what Paul. up kind we Matt to see and follow what for GIST Thanks population. to Steve. second-line to in of ask in the profile with the we'd INTRIGUE expect second-line this, will as to the we in as in reported but and of would is INTRIGUE question genetic the expect second-line population see expect generally a Hi, XXX-patient study, the on a I’ll know, literature. very population representative patient population you in would respect patient the be look to study, so like

of and XX% XX, balance terms in maybe up so would patients, would mutated X, then then primary about to X% see of patients. to a to alpha a to And exon we'd expect X% KIT the with be we of PDGFR KIT and patients mutations, expect wild of patients with type see exon XX%

terms expectations secondary look in that's literature the what in Matt, So of is distribution that you you see literature when there mutations? terms terms you of primary add to in else references GIST population would of of anything in generally for in mutations. a at the

Matt Sherman

And Cancer on earlier I been setting. in we was X in up both study September. the Clinical primary secondary second-line, also Phase the heterogeneity the back look highlight third-line, mutations had highlights that at think also the fourth-line of five that many patients just distribution in And the And in we Research of the seen that's we then is really that patients extensive X would and what recent study in Phase INVICTUS also publication the in mutational just some had quite harbor setting. there's these fourth-line mutations. showing of an to fourth-line published

will QINLOCK to recover that Broad interesting to as broad spectrum agents burden such necessary these be mutational this patients of note harbor. it's So that. spectrum

Paul Jeng

Great. Thank you.

Operator

from next Eun Yang And our Jefferies. you. comes Thank question from

Your open. is now line

Eun Yang

Thank you.

your late in said prepared Phase quarter. this INTRIGUE Steve, you So, X remarks, data

So the be data going is to in we that should assume December?

Steve Hoerter

Thanks afternoon. joining the for call. Good Eun. Hi,

very we is our INTRIGUE respect consistently results, on what guidance line with top four. to quarter So said

time any specific QX. just within we So quarter to that be of guidance this refined said have not We year. four

this that heard in was given have already me may later quarter, we're you QX. say So

Eun Yang

tumor INTRIGUE choosing Phase scans from later, XX you. [indiscernible] six cycle X, X in and day other of frequently? And was trial in then in scanning it ask just a cycles, cycle the convenience. But weeks in I you so So Okay. could want you cycle. done Thank more terms imaging every every cycles Phase on in aside cycles to months then every scan six study be rationale the every trial, done week your imaging two scan, are for of first patient done for other think the six

Steve Hoerter

thanks for question. the Eun,

Eun Yang

interruption. you potentially you. that every cycle XX impact every sorry would PFS? cycle Thank then Yes, for six think And versus do week days

Sorry interruption. for the

Steve Hoerter

Thanks that? completing for all would that’s thought No, Eun. you question. Matt, take and the like right, to

Matt Sherman

other you're is Steven. cycle to right. patients being Sure, related dosing scanning that every that's we The Eun. a what Yes, Hi, six-week administered. INTRIGUE the of sunitinib And study, X have cycle cycle. with of are a Phase

So that the cycle. period of a four and to dosing progress sunitinib one driving is constitutes weeks

time study that survival is progression across for very that dosing, of use type it's of be for of the the But cycle scans most for of the continuous Even companies terms same both [indiscernible] follow-up to So patients. we're the important two typical such in the study. what's will probably scanning that’s and arms though arms free event interval any for as same for the the prevents to bias event. the

Eun Yang

maybe on the certain I cycles. remember, was done trial I'm in for imaging of mistaken, day thought but XX [indiscernible] Phase I tumor all treatment If X

because mean six So does weeks that as off? every weeks it's two well,

Matt Sherman

don't We'd just probably at I FDA recognize study, back or the our though know. to that important Yes, But have for look look their for documents schedule. actual more protocol it’s that. to at their go and design

frequent cycle. is every other a progression, every for tumor four-week six weeks interval that a measuring taking it So like it's will many measure cycle, protocols, standard

that's So eight-week basis. in every

or [indiscernible] aggressive cycles. six So to reasonable interval for first measure those pretty

Eun Yang

vimseltinib. for on And you the Thank is clarification. last question Okay. the

X are surgery. enrolling you're not Phase to who the patients MOTION So trial, amenable

percent you Thank general? patients of form diffused not are of surgery actually what amenable in quantify can to you. So

Steve Hoerter

Yes, Eun, it’s Steve. question. Thanks for the

data the X that study the event, once really ESMO and population investor the presented we portions Q&A at of Phase ESMO with across earlier in in and from after the -- vimseltinib, the the pleased our and were saw study. X/X Phase we at prepared we also during XX% So to we Matt this see the remarks, Phase X patient response rate high referenced

encouraging little Dan are the also what to really see we bit today patients of these saw. Martin market So and not activity that time about in are and a in terms how being amenable patient journey how some these little treated, spent about talked we flow talking bit surgery through. patients a who

fact leader. very market these rate an at support is the Dan analysis in look used I’ll not actually the patients, use do, use second. approved to in for maybe in I vimseltinib, and point TGCT, in isn't standard one imatinib, for this that's approved despite Matt would to But prepared Gleevec, mentioned that response It's is I this before share U.S., when just the claims having So on its remarks low ask that data for imatinib the I that that actually I patients. these you a and the surprisingly in the treatment That's think despite actually not a think these patients. comment shows that drug make treatment his

granting that Track the that unmet Fast think in was really need I designation. vimseltinib FDA the reinforced speaks we to TGCT, medical So and think by

pleased journey? comment as patient were like today. announce well we just to Dan, on that you So would to

Dan Martin

the Thank question. absolutely. Sure, you. for And thanks Eun

lot not with a as populations claims at the and also, understand both to were to but KOLs, Steve and upon work size we our prevalent launch. U.S. be only the think that a ESMO we've for to to the really likely try of mentioned, of was eligible also So try drug the that journey incident patient review lot done, work to are

there TGCT. XX,XXX And are are so who XX,XXX in we diagnosed to we out annually what about laid that was with think the U.S. patients

true recurrence rate we as are and localized, localized And diffused. tend than patients patients. both that's mentioned, that there it localized is have diffuse a lot more but Now higher a to

recur surgery. And contribute population in the somewhere who X,XXX so there's would X,XXX to that to of think both recurrent surgery. order their first be We would after a year, after a

receive surgeries becomes therapy by focus, population where additional oncologists. may systemic But progress benefit. they medical some delivered Now of ultimately, and patients those some go to on get this therapy systemic as a

about and is treated several disease, is on who estimated be the about and the incident a the estimate given that launching, years. patients on currently we've Rx recently were that so U.S. meaningful we are X,XXX prior to believe And and this of then consists patients the within that time a X,XXX around in that would to X,XXX that we And that that patients be those therapy who systemic we population is non-lethal prevalent there annually. population,

we development point about of about the important a And TKIs out issues as lot mentioned, kind of And think uptake. from because it the that's while market other of wise. and there opportunity we of vimseltinib patients So really And bit the, a think with sort Steve view, summary consideration struggled little that and receive how flows. is the really of a size actually imatinib presents. it regulatory has vimseltinib a profile of

Eun Yang

are say for your eligible so not surgery patients really in patients anymore? So they timer that's surgery when for first surgery, you it had surgery relapsed, who are amenable a to the and trial that who or not not previously is

Steve Hoerter

on surgical a on who could with and be other of right? the it’s for patient's tumor patient, It or medical based tumor eligible intervention. be Eun, history maybe Steve. a patients based location could present not it either, So the

I not multiple joint There's patients, that think, diagnosed of had patients a surgery. diagnosed, a And in undergone have we Phase lengthy a eligible fact, was for in surgeries who become vignettes And multiple and from could have they the types woman total therefore, that of those to some surgeries, be including amenable years of with undergone So, newly shared experience. treatment, have or have we've ago then another a had Phase the both replacement. a who but the eligible. systemic previously patient who X vignette become And we study. journey then some was it disease X/X

spectrum. that's the So

Eun Yang

Okay. Thank you very much.

Operator

Thank Securities. you. from Reni question comes And next JMP Benjamin our from

now open. is line Your

Reni Benjamin

taking afternoon, guys. Thanks for Hi. the questions. Good

INTRIGUE it Just at steps Jess daily to to data? just the of and hey, what between that's coming piggyback wait I the off kind the asked, reported, call study. steps of color us that point, of the be? the for regarding from -- DSMB next email through but Just says, an take Do is might that. I'm after next guess the in it’s any can pretty is end year, not are, data you just something Is this there results regards how in now how up of clean you confident database for I getting the weekly? or sort that the you're guess kind what of long

Steve Hoerter

Hi, Reni. for It’s question. Steve. Thanks the

general in that answer and try me let So terms.

on accumulate a proceeding then to then the just complexity study, nature, with of to in needs able based and and study, and top do the the and the study course, associated report So lock the being the data the of statistical of those out number to line. this timelines course And with subjects study before endpoint, cleaning, the the event of number with any sponsor vary the each for events analysis time in of there’s to wait like. database steps, of of and can

the are be line prepared top So results. before steps would key that are any taken report those to out sponsor

Reni Benjamin

events. just get of you time the slip quarter second last And this guess can't based delay confident Okay. the but a very of on into first quarter guys don't the last or because I know the that time you data, when's feel I

You you've feel created. that about fourth pretty bookends quarter this confident

Steve Hoerter

line out of this Thanks top today why in guidance for That's we the INTRIGUE QX question, of for year. Reni. reiterated results exactly our reporting

Reni Benjamin

be should as ramp more proxy? just of EU in the of that kind kind line U.S. just launch remind it. looking the what the this the of a about And about as proxy key as the rest but I switching Got And and the to EU can more of then launch, those EU the preparedness think the markets you're or we a are, us good of you we world be should fourth targeting? we talked kind activities. at we've revenues past, gears using know maybe in

Steve Hoerter

Yes. Thanks question, for the Reni.

each So let address and components. me of those try

So us, on focus Europe. for the our five is largest in markets

markets UK, principally that those by course, I'm with despite Union. UK, that the of including longer the our are largest, the So five But the the team. no be five fact European part of we targeting is will

put what launch spoken always nimble launch the we've market in to that previously, timing fourth-line later markets. the been to And achieving cascade access. in markets really to our launch has markets goal Europe is expect place launch time about that drives focus to early see As a we territory. address would team in And from over across

And able longer. if to Germany, negotiations and Southern allows take freely, example, some the we're Italy as So markets like markets, to European price so markets, about you can pricing think an and in in quickly. very reimbursement launch other Spain, us that

territories. launches And in those would achieve so period we later at once market in access those time occur some

we expect that we the we're efficient at market adding very key in that build -- way way when our our human is need in resources get think about build to a is the territory. a so only the a And access very way that ensure organizational efficient in we time to

to I may respect question have -- think I asked think question great it's on touching uptake, was Now it and with that earlier. the a Chris

think in we of the in on uptake seen the that rapid strength setting fourth-line QINLOCK reasons ripretinib, of based data. is U.S. we've the the the such of One that of

[indiscernible] months know, long-term benefit QINLOCK arm in ESMO, and follow survival in tripling up as showed reported follow term So placebo the XX up longer the survival we months in X overall patients. for recently arm, versus which at the so with benefit overall you about at

from factor terms physicians their data setting, patients. think no aside the we QINLOCK they as options are options for us in for there the patients. about And a fourth-line compelling of of as treatment good certainly I helps these think being So in strength the for know

with driving of strength you uptake that that's drug data, when the key unmet factors need rapid factor a or combine we of the in set key setting. that's So the the think of

I might in we us for comment So see markets. premature think European in it's Europe, what on to

will think I market each different. slightly be

So and are talk the markets, terms be into how viewing in we’ll with drug get it. experience a uptake we're about hands-on of of as repetitivity to we what as what get in they physicians seeing, we the see better position

Reni Benjamin

me. patient ULK from biomarker I targeting talk patient is a you one the for levels regarding So autophagy inhibitors can there preclinical end are for studies? would where selection tumor your enhanced of look inhibition? model there -- Can -- strategy is And selection or Great. there one thoughts autophagy for of a for result that or you guess any a in final selection

Steve Hoerter

a great Reni. That's that. question, certainly We are evaluating

to spoke the be we prepared in well us is as indication in that treated as as changing now seeing with program escape also are mechanism however, tumors I in this data And certainly remarks, in the when internally, see There I Matt haven't to therapies. a a what's but what's pre-clinically, seems fairly any of to what's generating his for very literature. we're autophagy that we're only this tumors and think, for literature, think and of evolving seen reported not in been data starting widespread with of the upregulation we're that sort be targeted to specifically CML the us there common strategy. would based be selection solid seems on

that in lung looking preclinical cancer and been imatinib of our data own data referenced reported prepared the separate have and autophagy. autophagy literature CML other non-small afatinib published we the lung in At looking models. remarks, now groups upregulation at there cancer, as meeting, published at we group So meeting have EGFR of in cell osimertinib on the triple and LKBX effect the mutant looking at on

and by and mechanism we this of So the as an what in both that we're escape mechanism solid role encouraged see is tumors. confirmation broad liquid the plays

applicability potential time. of continuing, the us, course, also is our thinking in X to now with tells the Phase program how dose about what progress for broad over study. terms evolve of this challenge escalation think so clinical I may But And us

and by really have into and the certainly to seeing the what space we're leading encouraged pleased So the leader program very first this be clinic. to in we're

Reni Benjamin

the Great. Thanks questions. for taking

Operator

Thank you. from Robyn from And next Karnauskas question our comes Securities. Truist

line open. now Your is

Unidentified Analyst

the Thanks how is walk setting sunitinib Robyn. second-line questions. And research through at use would for taking This sunitinib for generic, the so be upon any on all? indication market speak affected price? you for bar Hi. touches QINLOCK [indiscernible] by generic that for is physician then QINLOCK you've done that us any affects there the going Can a to that in and

Steve Hoerter

question. the for Thanks

Dan of we, in fourth this generated market some relative of second-line referenced referenced perception offer we've with there the encouraged the the relative on So in of you'd quite how that we're research that to as see course, in terms of Dan, to to and their far from based And study profile there. U.S. of quite we're cohort. X by of sunitinib line, is understand about Phase earlier, physician done sunitinib, earlier, Dan response physicians so on a even the terms like thinking course QINLOCK? and bit details we've QINLOCK we the to in what data

Dan Martin

just color. little a extra Sure, bit

far. of we Steve thus bit have As mentioned, quite done research a

back the a what of be exactly and course, we it's give after And that treaters. outcome will research with to bit consistently comes INTRIGUE And concerns stack for take there be can sunitinib that drug important quite it of how done will and we've those is do of hard of up we'll of the profile, hard work a patients. with But course, far. understanding to eyes thus results. part really in additional sunitinib have are really Of

to and want And so line. and INTRIGUE community, second are in QINLOCK for rooting both the really academic use really physicians, and it they

came sunitinib In to fact, physicians, side. treaters, side as asked mentioned QINLOCK fact, rate saw prepared was of product significantly on the by basically QINLOCK. scoring just my we in that for attribute did a the some we just by was we research, in higher attribute fair And top tested. statistically amount, and And attributes every we remarks, of out what for on nearly all QINLOCK I where

why the think clinicians there's tells the to that us what in looking think eager is really anticipation second much I So and use that's INTRIGUE so line. that I to forward are QINLOCK results. And

to the relates based sunitinib, make generic that As the on we clinicians most day, clinical their think at it end decisions the evidence. of

with positive a us with think will in study also and position so put payers. treaters great And we head-to-head

of to different value look we head such, to factors, gold payers demonstrating trial, and what and head that's end the to cost for the obviously While values have. the day, head standard and at head or clinical

we for of forward the we’ll launch we So line. INTRIGUE be in a a successful results, readout second look pending believe to the really good position and positive in

Unidentified Analyst

if I good. Sounds And can. Thanks. one more

it’s it touched at all? with been doctors seeing you label quarter our think And has we've doctors, are in I use but from on interact second and a line? with sunitinib what before, when this you different been the

Steve Hoerter

question. the for Thanks Yes.

I'd happy to take be So that.

how Is relates quite at dosing work your done physicians use really I a So assume correct? to looking that schedule. we've of lot question sunitinib.

Unidentified Analyst

Yes, exactly.

Steve Hoerter

mixed bag. we a what see Yes, really is so

isn't dosing used one schedule that's sunitinib. standard there with So any

two see often that the probably patients of you So everything weeks milligrams reflective dosing XX the with labeled milligrams day on, are getting just we XX per that's weeks way challenges down schedule think seen to all of and tolerability are who off, from sunitinib. four the

Unidentified Analyst

my All right. questions. for taking Thanks

Operator

comes you. question next Canino Thank Stifel. Brad from our from And

now is line open. Your

Bradley Canino

Good afternoon the the for then and on approvals and one One on on congrats QINLOCK. pipeline. additional INTRIGUE

rate INTRIGUE censoring been early into remains data, conversations back high the the As the heading XXXX. my having points of one of announced you in I've sticking

to like the what PFS drug So that this will either measure you your to for is just I add confidence ask, of that censoring not bias have level arm?

Steve Hoerter

the for Thanks Brad. question,

isn't of a about. spend this thinking something time So lot that we

really at regulatory pleased from of with following the how around announced So in the patients conduct the world. the INTRIGUE addition beginning pandemic year. the team navigated regulators last of and and guidance has the during of particular, we study We're the

how the we're forward conducted at things and line. top looking been pleased So reporting with have to

Bradley Canino

on And the then spoke you Okay, about that. length call, I ULK the at inhibitor. appreciate

combination you Sounds ambitions like multiple pretty grand have trials. therapy for

you've cost So be data better you retain the Given Steve, asset? with already on shareholders about the so, three programs and that out X those? drug Thanks. and the Phase license and creation ULK value to but co-develop? And inhibitor that are if how for you the establish program Is asset? for thinking spending stage would this think where free R&D at do collaborations what some can share or for value you you in

Steve Hoerter

Yes. Brad. Thanks for the question,

remarks, potential of So on prepared course as in this really meeting we're reported the the literature. the And ULK the excited program about we broad the been and reported in what's Matt to in the we at spoke mentioned based some triple data and applicability. detail

targeted potential to solid we have a agents. combination believe broad different So and do that program applicability potentially very range liquid the the variety has in in tumors, of with a of

in to be months agents. hearing the we to inhibitor prioritize sure take to I'm forward and science the the looking other here combination want to you'll in us excited from we're terms with we're And be So to in where how coming ULK continuing just more respect follow might But comment it build prosecute about on to the partnering the But specifically, to long-term value. me opportunity premature program we of that. would decide for and that. with to

Bradley Canino

you. Thank Okay.

Operator

Thank you. closing remarks. Steve to And I turn now the no over like for call Hoerter I to am back showing would further questions.

Steve Hoerter

continued call everyone have Great. hope you on on Thank for we joining Thanks I much. all support, and our evening. progress. keeping us to thank a forward great look your you you you continued and for updated very today's

Operator

today's call. participating. for you This conference concludes Thank

disconnect. now may You

Deciphera Pharmaceuticals (DCPH) 3 Nov 212021 Q3 Earnings call transcript