Turning Point Therapeutics (TPTX) 4 Nov 192019 Q3 Earnings call transcript

Good afternoon, ladies and gentlemen, and welcome to the Turning Point Therapeutics' Third Quarter 2019 Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. President. Vice Senior Mazzola, Jim Please go ahead.

Ella, Okay. afternoon, good Thank you, everyone. and

of our close news for summary updated today, market Form investor release results, presentation. our we a a Following issued filed XX-Q and quarter, the with our third

documents find Investor pages on may You posted tptherapeutics.com. the these all of

quarter and review business will by our overview provide financials Leading President and today of results Dr. CFO. Officer, update be will Executive call our followed an a by Athena third Point's on our Larson, Turning Chief Countouriotis, Yi who

We will take questions following our prepared remarks.

to begins, I statements. you Athena may conference forward-looking expressed Before this actual indicated call, Company's will want differ forward-looking remind making or that those from such in be during materially results we by The statements.

factors Therapeutics, Turning risk filings investing a including Exchange recent our filings. description please to the prospectus associated Point Securities with and our Commission, of in with quarterly refer and For

over turn me Athena. to let the Now call

joined happy call. Chief very good on us today's of be I joining and afternoon Officer, Larson Financial progress over the the to everyone Jim, proud Thanks, to made them. Yi has of milestones I by I am today. year-to-date. am as quarter pleased XXXX; past outlined accomplishing multiple team our important This year, for very am today, progress and and towards with we the our

I you today's milestone. an give will During call, update on each

company. RET TKI-naive patients. ROSX, differentiated numerous and TRK, next-generation for inhibitors medicine and start reasons discovered target TKIs cancer, why kinase or highlighting namely tyrosine drivers our precision pipeline MET, want Turning we have both genetic and in use by of Before Point get wholly owned TKI-pretreated that ALK, to details, Turning is the I a I into Point, developed believe internally At we of

design Our limitations overcome macrocyclic with platform potential conventional the enabled kinase to inhibitors of TKIs. the to multiple, small compact us and has

therapies. intrinsic and challenge resistance One of response TKIs limits the and existing rate response limitations with durability of of of conventional the pervasive is often acquired the that

the called acquired is and of is area the an therapies kinase cause challenge of to ALK. One for TRK, resistance of approved which solvent-front, common emergence the currently in mutations a ROSX,

addition, that their approved and In TKIs their other best-in-class, that from believe investigational based are generated our and arise to RET design, and precision platform potentially ability than will macrocyclic their has potency, inhibitors. affinity their on mutations we with inhibitor bind rational to targets kinase and greater current solvent-front

for patients now a evaluated candidate like drug would being lung from with quarter, highlight NTRK, is repotrectinib II with solid advanced for I to registrational advanced achievements our in key ROSX-positive, non-small tumors. ALK-positive ,and of or the the which treatment with called TRIDENT-X cell Phase starting trial, lead ROSX, patients cancer

First, Congress announced European portion updated Oncology. in I the presented early TRIDENT-X, at we then of Phase data was Medical from which the of preliminary Annual for Society September, the

results these data demonstrate based believe clinical potential and continue the potency ROSX earlier We of preclinical to Phase TRK inhibitor the on data and repotrectinib to I year. best-in-class be this shown a both

continued from reported patients and year, solid to a to patients. TRIDENT-X has for ROSX-positive TRK-positive for treatment repotrectinib build in Phase I cell it last ASCO later-line Since and settings lung non-small time confidence front-line of study, the tumor potential have advanced improved agent data each the both our cancer in we best-in-class the be and

in progress the achievement our for advancing kinase pipeline key to second lead program. that strong quarter addition is inhibitors The of we our made

other initiate very advanced submit soon for clear to cancers. TPX-XXXX pleased During thyroid, the our and expect novel study IND quarter, our cell we in patients RET lung, RET-altered I/II Phase were inhibitor, with and non-small to the and

and IPO I novel in milestone we time key make submit the set the ongoing progress MET study inhibitor in our Phase to at to A of have We TPX-XXXX. of our INDs the also April am TPX-XXXX team was to achieved so all both initiate of proud the year. they year. the for and our and I for studies and end both TPX-XXXX accomplished of prior this clear continue

TPX-XXXX XXXX, stock early $XXX.X our in in cash sufficiently in is first we million offering we which September Study funded of beyond XXXX. proceeds. second the And September $XXX we With believe raised are which readouts from our Phase net project last, TRIDENT-X we the in and Phase the position of past our both data half II XX that we completed I follow-on study million, at

I With repotrectinib evaluable and advanced XX on lung including from efficacy that patients. of in ROSX-positive patients the total we XX non-small a cell NTRK-positive update will tumor comprehensive background, patients, cancer a solid more data provide reported two

results to well tolerated demonstrate The both with and was showed safety generally profile TKI-pretreated in and activity patients. repotrectinib continued clinical a TKI-naive consistent

without of with responders As of non-small response Review the from of event time duration XX.X median data ranging lung months. of a cutoff, analysis XX% yet July achieved responses mature Central TKI-naive, by ROSX-positive cell confirmed rate patients. Independent not was XX.X time in XX response the plus to overall was With XX% plus follow-up an and at a the months, Blinded X.X of the median cancer

probability is duration crizotinib with estimated the response said, the greater duration or a of given months. approved of method, That was is at median encouraging XX% months the agent which using response Kaplan-Meier of XX XX.X the

benefit, nervous with were XX.X responses central of very for of XX.X system with achieved in the and disease time within data months baseline, TKI-naive CNS important the measurable patient confirmed plus to long-term activity durations three the addition, cutoff. all at at In patients is

all was shown confirmed treated at confirmed these ORR patients treated XXX milligrams overall was or patients rate achieved TKI, dose the XX% of Phase II a In above. in with one a XX% across doses and prior response

a was solvent-front with known the confirmed patients crizotinib-pretreated the rate response Among overall mutation, XX%.

TKIs, previously responses data ORR We showing in cutoff. with prior XX% a of also reported time the confirmed of two patients at pretreated the

the encouraging treatment for these of quite one with either pretreated in rates options TKIs given Each limited response prior two patients. or are treated patients prior

cohorts populations within these lung registrational TRIDENT-X Additionally, ROSX-positive ongoing II Phase cell study. represent the individual cancer non-small

previously solid in response the In patient. patients. tumor with to previously lung activity by in was cancer, September, addition treated response in reported and NTRK-positive entrectinib, a a first crizotinib and our repotrectinib we non-small We encouraged who cell remain with TKI-naive, TRKC patient a cancer data durable reported advanced in mutation, in solvent-front the had clinical of ROSX-positive, thyroid a

We II activity remain both represented within patients, in TRIDENT-X. initial populations our portion the and encouraged by also pretreated TRK TKI-naive Phase patient of

for now sites to and Moving our portion TRIDENT-X. call, last our patients. continued we II global Phase activate the Since have to registration enroll

investigator high. was last we in where Asia-Pacific trial the meeting, engagement Just completed week, our

investigators potent the most repotrectinib. should we TKI theme be or very ROSX The for the positive key in is hear utilized we continue TRK setting, from which front-line that is to believe

patients and next running our Our team to remains and year. get This our remains as of sites up possible. priority as quickly very motivated year through into the top and enrolling this end

Phase six of As patients following regions. received to maybe and globally of I is Phase TRIDENT-X cohorts, single-arm United registrational, approximately a late meeting expected States, about II the based at Of Europe sites XXX reminder, FDA XXXX. an enroll in end from portion on we Asia-Pacific five the XXX in the feedback

and the enrollment our at timeline a will time. enroll of on for later as continue activate study, have timeline visibility patients, a our will and we update timeline terms to we plan II In sites registrational Phase to on better provide for we an

the am sites stage, initial cohorts activated additional activating with I during to registrational early At and Australia the in provide now of soon. remains with U.S. sites pleased our from data our some many of an early XXXX. patients from progress second It half interim and goal the this readout

initiate or our to tumors. very repotrectinib in Lastly is patients XX. for soon. This advanced single-arm solid to repotrectinib, repotrectinib will open-label study NTRK ALK, an track study pediatric with in important on Phase ROS-positive of age study we under in the I/II This patients patients evaluate are pediatric assess

with combinations to we evaluate studies. future clinical Additionally, continue repotrectinib for multiple potential

here, about next on in excited providing look to next our ongoing and and NTRK. early research, an and I preclinical update am I steps translational the forward year. see we based potential ROSX beyond on potential repotrectinib the

transition repotrectinib, of With want SRC I to our and to our CSFXR that pipeline, development for MET, inhibitor. with beginning summary our TPX-XXXX, plans

with sites progressing MET alterations Our advanced enrolling patients. Phase solid in open-label tumors with and is study in screening patients I well now harboring genetic

reminder, standard to maximum a preliminary at efficacy TPX-XXXX. of design XX the milligrams dose, escalation study the determine daily starting dose profile and is As safety a tolerated overall

It Upon enrollment determination targeted half Phase then the recommended update would the approximately of goal sites initial region. data during our provide for in dose, second to of at remains evaluate II Europe study XXXX. Asia-Pacific the of expansion cohorts and patients multiple the U.S., an XXX dose

Next pipeline RET/SRC novel our is TPX-XXXX, our inhibitor. in

for compounds which against including by encouraged for LOXO-XXX against at stronger potential based with is ESMO potency BLU-XXX We KIFXB-RET, to preclinical the solvent-front on comparable proxy are its has shown and mutations GXXXR. potency wildtype TPX-XXXX

key SRC as a XXX for of and differentiator design and the SRC potential kinases of is compact has the involved tyrosine RET multiple inhibition the in We recruitment to of reduce receptor resistance. bypass its both believe targeting

was It active progress for XXX. of an quarter

team September very just by data this Phase soon to which September at and and submitted IND on accomplish IND initiate study, cleared our after As soon a ESMO, in achievement preclinical be to which so huge we I/II XX. occurred showcased expect our the will clearance

exists. as need working we with as We unmet believe clear investigators soon there as sites activate possible, are a to still our is that

RET-altered non-small study of to cell designed thyroid advanced and XXX The with Phase cancers. I/II clinical lung, first-in-human patients is enroll open-label other

approximately find plan portion assess in portion efficacy. cohorts the I with and approximately Phase our will Investor We II in Presentation dose XX updated posted study expansion to safety, tolerability, the and You PK in Phase on enroll website. design the patients escalation patients XXX our multiple to

II escalation II registrational registrational, pretreated study be designed patients. on to we based path a starting plan we Phase health the and The with the for having dose similar repotrectinib. portion a taking intra-patient approach to We RET/TKI-naive in authorities of design potentially as tolerability the did the would discussion on about TPX-XXXX. both with Phase Prior allows portion, study

inhibitor. our to continue progress toward we ALK selection candidate Finally, for make next-generation

XXXX our studies. INDs across this four clinical out and year for goal trials remains plan initiating to submitting Our candidate molecules. pipeline two later The laid of our we IND-enabling nominate three for included

positions raised of We us in of and goals in recent continue to our deliver The funding initial offering September, enrollment clinical progress achieving April XXXX goals our toward and each ahead beyond. these in our have to both offering excellent made studies further this XXXX follow-on against often our to projected and well our we year in well in in public timelines.

Medivation, for One Chief growing Medical final recently Hirmand, and Officer who Mohammad, date which which important the announced for me, most Peloton, Point by the by Medical as Merck his excuse Peloton acquired in Merck was Officer. Turning Chief of was Pfizer about and was Therapeutics, Mohammad – acquired to start as Medical which Dr. Prior our we Chief acquired July. hiring by Officer note our role XXXX. team. in Today, was

member a I is early has team development strong be happier develop important forward as current background our future. Mohammad our in will advanced and look drug in in of we introducing team our him clinical joining and to the near pipeline. studies oncology be I to and further our December not could Mohammad an you

call and that With I our financial the Yi over to to strategic update, results. operational discuss will turn

August. Thank quarterly everyone. very call Therapeutics I be in Turning first you, since good and Athena, joining on to afternoon, happy am Point my

company the As to know, on join additional progressed and dates as IPO. Point banker that team, the pipeline the back rapidly Turning given TKIs into the the role clinic. company of with lead decided Sachs from may I the have Goldman the the history encouraging to data repotrectinib you with leadership, my my

look seeing am to In and and I our as have I engine. Officer, Financial at many my more you to company of addition on to corporate further excited role with to already and you our to and of discovery team continue met strategy the conferences. scale work strengthen upcoming the development Chief forward

expenses million, and million and Turning the out teams. totaled we trials XXXX. $X.X quarter. in quarter, Similar financial ramping to an sequentially quarter compared third last of from build of expenses second our clinical the quarter to third of initiate increase million are Operating results the as to the $XX.X $X.X our

Primary headcount stock-based in made the to expenses. drivers year-over-year were and of include expenses have non-cash the develop in the $X.X repotrectinib added. quarter rest the Operating also of pipeline, third including compensation increase we million investments our

stock-based also driven $XX.X For $XX.X the year The during as year-to-date expenses were million stage for the assets, operating million expenses months the XX, period. increase as personnel compared non-cash was development nine well expenses. three clinical $X.X in September prior compensation. Included to is increase in million ending by our

cash used Net $XX.X in million, operating Moving bringing activities balance the cash million. quarter was operating used cash in flow activities and sheet. to to year-to-date the $XX.X our during net

$XXX.X to current marketable operations driven $XXX.X of cash, proceeds our June securities by September million. follow-on project equivalents of million million were at net XX in was as September The Our We fund our beyond cash now offering and will cash XXXX. increase $XXX.X XX. compared position from

quarter, the for clinical Looking we from trials launch execution fourth ahead third patients. the pediatric in in quarter, increase we study will and expect three to as fourth invest our a continue stage to clinical the assets of expenses

And call with that, let back who closing me will turn comments. the Athena, to provide

very with against made have we pleased our am progress I the Yi. year. to the you, for date Thank plan

data is the outlined took in complete every earlier schedule action milestone follow-on funded readouts in to through to nearly company key offering ensure achieved year and have we our We of this ahead well XXXX. often September

last As against the our to I the months focus will year, on ahead delivering milestones. we of to two look continue

to, remain of ALK We to work sharing development forward goals our Phase study enrollment for these of XXXX. clinical our advance our of candidate preclinical progress patients, support clinical our strategy each trials, on each I/II initiate look pediatric TPX-XXXX, I/II in Our repotrectinib. Phase our inhibitor of our to in nominate a against program, repotrectinib initiate continue goals in in study to ongoing and focus combination

want Turning accomplished great by I team during year-to-date. quarter to the and thanking close for Point they all our

incredibly as how big the humbled than to have team ourselves talent set and we this accomplished. Looking we and have employees XXXX, back proud to we am attract approximately continues of team what so company We from past for the employees I a at XX I to quarters, by grown less am the deliver. XX continue now in four goals and

for Operator, the you questions. open may now line

from first Our Guggenheim. Schmidt the comes question of from Instructions] Michael [Operator line

Your line open. is

and I my I your study Hi, progress questions. taking and all recent guys. XXXX. one the had entries, on more Congrats thanks on two for XXXX Phase or pipeline

these Just how generally add those us potential to toxicities degree what inhibition for be SRC could agents, potential this RET remind the MET as two respectively, aspect to a of speaking, the could you well? might the inhibitor factor molecules and and potentially differentiating

the question. for Michael Thanks, sure. Yes,

I One or SRC of the bit two is, have in things on from and experience bosutinib quite Bosulif. a regards prior dasatinib to worked I've inhibitors SRC here. of both

is it we're part different of you shown past a so here, in of selective. in that's I and doing is repotrectinib is to I for designed be the has exclusively think clearly was what TRK, been know, but ROSX be the and just maybe the repotrectinib than think not way what SRC and highly to was also specific that one beauties of

the tackle and called adds and of believe that to family our differentiate That And pathway. ways SRC MET inhibitor benefit SRC the part has ability one of those of and its our That to selectivity inhibitor XXX SRC which of and some STKX ahead where we of versus into included bypass is we of repotrectinib are that kinases, that RET us. also what's could through bypass the and resistance what mechanisms translate the both activity. XXX is potentially believe

you, Very to I and good, guess next brings my that thank question. me

think longer it about sounds RET and So, of along understand potential Can term? on help to earlier. know outlined us but little is the do you XXXX how XXXX here? the think compound a it's bit you still in about call study the relative Novartis the like you you just the design further how early, positioning capmatinib inhibitor, I

I'm and happy has of XXX, repotrectinib enthusiasm, think are just When because focus the that, would as first hear been much. have these most say the we on very I Yes. I to your and at I interesting it's coming. XXX. that look questions

proud working has for XXX. the Jean specific. the same that years, most she more of, that is space been in MET which earlier, I molecule XX this is is again to And over said being and theme capmatinib the

is really, to focus XX hoping are beyond in we area where mutations. an skipping for think XXX I exon again

in the compound that's comparison think the relevance of mentioning. the I terms to So, you're

believe to I are we here. prove have there really do things two

medical is benefit for for MET for inhibitor. also unmet been still is another our clinic, two, you've inhibitor need MET in CSFXR one outlining an SRC the the think as that and I there with

very definitely patients seeing as I'm the have am enrollment been enrolled. Phase study. of a with pleased here that II with I've I diversity the been

So I do believe we're starting that inhibitor. is for to need there medical a unmet show MET still an

said, I second come through think we're update the we've of data; second the to component an Phase and in next I will in toward guiding the benefit year. from as CSFXR and of half the SRC regards the

think patient the But the I I in Great, follow-up II interim of more, when the study, of analysis and the know year. you. next we the from from we mentioned initial think on half portion population? especially Phase thanks. updates or the repotrectinib, should study you about Then one about maybe Phase TRIDENT of data of how durability ongoing additional data frontline Thank the second

sure. Yes,

Phase I priority prepared as making patient only far with for you they're with well pleased progress II is investigator as as the top site as I'm and said in the remarks, engagement team. know, not but by enrollment, the our activations. So, also the

numbers, of updates. in going so the That's II our to to will standard to in data be you guide time you give points. quarterly we meaningful not regards In know, but all our just toward not rather terms trials, of Phase try enrollment practice

in relation you as not I Phase that And updated so XXX just IPO. second twice Phase as next the been update is of for since mentioned I, saying the half the we've In an only to know, the what we've II, but year.

data I. of incredibly the high the to my we've ESMO, And cut we just Phase from II last improved not show, on From level April Phase within data that year but again based in data the this continued from improved. year, the is data also the confidence further showed that to ASCO now to ASCO, and the

I execution. a team am XXX% on focused now trial putting the

are second about reading half of have the trials we're clinic to very two the timepoints the to in next in out We our and soon and data year. third that the fourth year

I So at Phase another intention the this shared the dataset encouraging our the median for not and with amount to again that a information because, the do again median I, point, that response knowing XX to obviously number but was from encouraging, of follow-up the is patients the not over months. mature that's crizotinib at continuing follow XX already of it's months, team yet incredibly of update we've duration is in think

Thank Helpful. the progress. congrats on you much so and

Thank you, Michael.

Thanks, Michael.

Our comes the line from from next Paul Goldman question of Choi Sachs.

open. Your is line

pursued population here? would by that Athena, to combination are that Hi, you questions. And on leapfrog you everyone, us you EGFR the the or is articulate could good and potentially thanks for potential hanging trial a of think competitors? fruit lowest taking other being as with for in look repotrectinib, you some sort of the combination then can decision the study the our for maybe maybe afternoon, help patient studies for go staying pivotal Tagrisso, planned what what no-go

for you Paul. Thank the questions, Yes.

First one that of activation all, having we're looking is potential as SRC utilize obviously STKX the before, could benefit of previously, I bypass we the at quite think with ways pathway of repotrectinib a within few in inhibitor. combination the combinations. the we EGFR discussed We've said and

other combinations. we novel evaluating evaluating still that We're as are

Again something go, it's to little too still So early decisions trial that point, we're design. at. no-go a talk looking it's regards in at about to this

really be call strategy that strengthening also biology, repotrectinib, But but internal looking the chemistry been we're to made research, last discovery the only conscious efforts. with combination combos, effort our highlight building not translational future to further on able we additional a I group, at also we've the our think few quite to develop and

a no-go, we're designs year. and give multiple in still next said options it's that little go, So data early terms that to because we looking give at in work some to combo regards early we of would

us for turning XXX you for maybe Then of on RET, a moment that. your prioritization maybe to trial Okay, design back either give thoughts can you great. and Thank and population as simultaneously have of potentially near-term? treatment launches the the given plan or that treatment-naive the could category at in them the population you to is or the drugs two experience the over go

as in Obviously, a components what of lot Phase would dose Yes. standard optionality Phase that be escalation essentially be than is Again, we're programs. standard ahead expansion, I. There Phase or would I and I a say to types, is XXX similarities based is escalation gastric hepatocellular. it's no. then there doing such the the at on looking we of multiple whether where disease prior of That long regards yes different further with XXX. GI-oriented for is both or a used, TKI I there, or diseases XXX will

said which again quite The show updated The definitely our did the as and I/II Phase different we've design. presentation much repotrectinib, prepared RET we is what allows is in mirrors to remarks, RET a a we and optionality. the with investigator now bigger of design, bit

disease-driven, a there is toward would versus so be cohorts I escalation TKI others component, TRIDENT-X used, II, platinum thyroid or no. Phase we but in yes Phase to again options like proceed lung, There are and regards prior used, prior just as dose that multiple

maximize of the ways our RET I at could from think tried and other timeline to potentially we there inhibitor. learned that take of the the for ahead are agents we've investigational lessons look us some

Got jump you it. Thank into for queue. that. back I'll

from comes Andrew question from SVB Berens the next Our Leerink. of line

open. is line Your

will Thanks. repo. on brain on typical think Congrats with of There couple of patient do a the the mets I mets? and of are have in what guess you guys progress. patients what's questions a brain percentage course TRIDENT,

Yes.

data strong one frontline, well Andy, three in been activity of you setting all having line second frontline in we've things monitoring, is very as And with the obviously responses. we as extracranial. know, both patients the the So, have intracranial as and the

setting. in disease You XX% measurable intracranial the had as as well pretreated

patients is the and but somewhere – mirror really trial we a the are does setting patients, upfront our of literature, the of but on the on saw in incidents. that's of for the us but terms that somewhere incidence estimates in depends the it kind the patient for it most half around Our setting, versus depends supports and it the pretreated seen of higher numbers we've potentially in population, what literature itself trial around

So in third-line? second the and setting, is frontline the it's which higher than you're saying XX%, in

on what in pretty looking consistent at. It dataset the seen half with which again really patients. the you've depends literature, is In was our you're that data hands, of the our about

Okay. progression typically And how survive they do those long without progress, idea they long usually and how once patients will? any

OS I me have front be able to to in of that, don't answer the data Andy.

paper don't see was I I I think what you What the depending is similarities could say or probably PFS so between historical from have see the OS literature the crizotinib and you're similar the showed ago. at response the about relatively months looking is data, whether the six they you that presented entrectinib rates when numbers, duration you rates. know recent and don't on that

in that, literature may Now that I the of have but don't have my on top head.

Okay. then going? launch any entrectinib I of idea guess is the how And

watching been clearly it. We've

beginning It the clearly. August. obviously still, approved, of in days early its got think I

I way nothing we in repotrectinib think be registration a will and again, the believe post to has approval. obviously that utilized path changed regards eventually

potent that on We will frontline. is the the believe based most still best-in-class be that it it for fact agent,

patients know you not have who have not does is and activity resistance. As approved entrectinib in

So area as an we well. that's clearly differentiate will

also patients trying aggressively patients it them to then, enroll And XXX, or those then be the to and difficult have RET trial? XXX identify how that I enroll will LOXO enroll Okay. [indiscernible] failed the guess in just them or on the program,

where would would The that came give the out this is team of ESMO say park. credit incredibly the basically of one our cleared incredible ESMO completely of I what the The we I at only is time out motivated. they've which enthusiasm, one compounds. in for molecules We knocked versus both it the head-to-head terms to amounts of data, proxy was the you're for not saw investigator referring IND was and thing first of

clearly and time. But that these some potentially the a clinic we investigators that right resistant is multiple is at to the coming treatment molecule heard also of occurring from can mutations overcome resistance

has to know to going trial the predict obviously, from too patients except not amount get of the in to terms soon, enthusiasm very waiting. I'm the we a much say enrollment, are because investigators of we're future and tremendous trial initiating going that

Okay. Congrats Thanks a lot. again. Appreciate it, guys.

Thank a Andy. you. Thanks lot,

Sure.

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

open. is line Your

like guys. progress. to follow-up Congratulations Hi, the Andy's I'd questions. one on maybe on of

active about talked some you the for ESMO resistance. investigators agents agents of about against the need active – You shared with

talk given a a that upfront. lung about? of the docs about you're a kinds what are in planning with decide Curious then potent forward the that clinic looking using have might go on molecule lot How ALK molecule already? into as most well, talking they've bit And characteristics about the you you talk the inhibitor in that to what you to fit for what little drug you. of that versus Thank you can been

Establishing setting for fair, with here do think be XXX. Thanks. said us Arlinda. to Sure, I pretreated a may it uncommon Yes. is and before. in The I've one efficacy thing say this would I was not

what Our repotrectinib. did RET inhibitor is we with exactly

in the are believe terms be wild But with prior showed ESMO, Phase of at flexibility RET/TKI without we from setting. and perspective allows kinds The I design a potency can very in we enrolled we patients of as comparable all type use.

determined probably conversations that's to on the it clinic, will the based this So I I'll move and is for about into investigator. we've unmet think another need where really leave At point, medical be an been it. clearly the having RET

other and/or resistance if to I we talking of those types TKI-naive. captured from be occurring who want clearly, agents are about of then that patients we'll start within more what our all enrolling and are are database information

the as and our not no as current out, where of From only GXXXXR mutation the available hit Clearly, one ALK repotrectinib ALK have candidates compound areas mutation, of inhibitor team ROSX hit characteristic, potently the it series but as you is address TRK. therapy. and that does not there know does that can Jean ALK a the is common on focused an most inhibitor really for also but solvent-front does been

equally, lorlatinib. think for profile differences our between repotrectinib and there are big I very for safety

ALK new of I can into so would just inhibitor, And we're candidate but that some if as we a be again, encouraging that nomination. incredibly translate a safety difference well, think

can if we're that agent I continue unmet there medical a need and So for be especially lorlatinib that that the ideally is what need looking the setting. by think moves clearly, to frontline, not an will addressed second-line in is something to address still up

you. Thank

Thanks, Arlinda.

Next question?

from line comes Securities. the Jim question Birchenough next Fargo of Wells from Our

open. is line Your

on Hi. taking Thanks the question. Yanan is for Jim. This for

So in other In repotrectinib, just data? resistant on you the maybe interested some mutations. so repotrectinib, particular, whether from trial ROS question to mutations potential first to I'm sense progress resistant have patients is clinical do who

repotrectinib with compact not? is will preclude it mutations first-line XD or it Since resistant doctors And in want has footprint? larger automatically very preclude possible use that whether structure, Thanks. – also whether repotrectinib may a inhibitors other impact to that that

Yes.

think I From it's perspective within data within very question. not the that the a Phase Phase the repotrectinib, captured was II. captured will study. resistance I of good It be

just tumor within the to prior their obviously, biopsies Phase level enrollment. presence evaluated So to set, have, study, II fusions patients who the for of

the or three to presence biopsy, cycles liquid biopsy to into the will to prior liquid will resistant They evaluate have approximately two of also baseline another mutations prior treatment to time addition, to enrollment, progression. repotrectinib. of and on tumor then tumor at In end a of they treatment coming have

the are So answer have not capture I of that have question with to opportunities potentially mutations do resistant the today. we'll two to repotrectinib. what occurring

that's do there mutation frontline. know dictated going in that point not made repotrectinib utilizing about for to I be resistant repotrectinib. by think that you the I

our and to that shown rate potency been think its regards already the is fact in has XX%. obviously that over response story I

the for of a and amount back is repotrectinib frontline, and is is I – approved upfront. reimbursed, so came using at and much study very fact factor think the to what large there to given the crizotinib in specifically I a but for it from meeting tremendous And now more is potent, obviously me, enthusiasm that team Phase so just it key utilize II that the driving there Asia investigators

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Yes, thanks.

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you, Athena. Thank helpful. Very it. Got

Thanks the very all questions. much for

I'm Jim at no time. the his Mazzola now further this Instructions] to closing back conference [Operator to showing turn I remarks. questions for like would

to happy step call. right, for I'm to in want participating I thank Athena. really All for well It's to the you obviously team. in the Jim. say everybody, thank you

you I of upcoming tremendous look all many you year. have throughout a to seeing job banking at done forward have And November this December. conferences dialed You for of and that in,

now can close call. you Operator, the

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

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