TPTX - Earnings call transcript Q4 2020 | Turning Point Therapeutics, Inc.

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Operator

Ladies and gentlemen, thank you for standing by and welcome to the Turning Point Therapeutics' fourth quarter 2020 conference call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]. I would now like to hand the conference to your speaker today, Mr. Investor of Head Mazzola, Relations. Jim Thank you. go please Sir, ahead.

Jim Mazzola

Thank Good everyone. you. afternoon Okay.

for our today, a and results and close market Form year summary fourth XXXX. full we our with Following release filed XX-K quarter news issued of the a

presentation updated update tptherapeutics.com. Athena find of these you also our and Dr. our and call the an who today Larson. on We will followed be financials review Yi Turning and Investor Chief Point's Officer, by posted President the may results. business Athena's Countouriotis, provide investor CFO, our our will on pages Leading documents will a be overview Executive remarks by of

take are three will We locations prepared following of in remarks. us The today. questions our separate

So please bear with us as remotely. we call manage the

want conference forward-looking to for during differ forward-looking with with filings Point Therapeutics, I of be making please materially that you or in risk call, Turning such the Exchange factors statements. in The expressed will to and indicated begins, recent company's results our this statements. refer Securities remind by from And Athena Commission. actual may description investing we Before a associated those

Now, let Athena. over me update the to turn

Athena Countouriotis

our Overall, us Jim of continue share updates to afternoon that target good you everyone today's internally we progress programs drivers and in next-generation four to our developing want genetic discovered goals cancer. across Thank Today, XXXX. call. to a our I briefly joining for progress and our tyrosine of recap kinase on XXXX, number on in inhibitors focus make

profile, interval to cutoff the response the of recap we at confidence of lung cell a from XXXX reduction. cancer data XX XX% a higher XXX. confidence XX-fold are directed best-in-class non-small the oncology. scans greater In in pooled rate which type physician XX in Phase Repotrectinib the regulatory crizotinib portion least growth. XXXX XX repotrectinib. we a States greater data to cancer. XXXX, had of and as for study. vision a TRIDENT-X encouraging non-small of ROSX. in Phase we advanced The XX we with cutoff, toward rate January pipeline post XX% preliminary United next-generation TRIDENT-X, XX, term a was Phase TKI-naïve in program, TKI-naïve potency clinical objective patients our advancing portions on discovery our treatment one our have XX. with long the preclinical Starting leader we The reported than engine TRK XX% X all patients in our has patient, an from remained ROSX-positive, made date lead and TKI, with of preclinical non-responder several a study. polishing data designation cell In of tumor the investments assessment precision the registrational XX% In with XX-fold believe addition, progress wild have than Repotrectinib and ROSX response and or two patients X XX% granted and of a to confirmed data a time with goal are Phase is against for investing be TRIDENT-X updates therapy higher December the support key potency potential XX breakthrough of been the interval At X metastatic with confirmed than by lung in of was ROSX-positive, entrectinib the treatment X overall the with XX baseline including designations, than To the

a X rate central XX% in treatment For confirmed duration pool Equally patient historical by the of of and and and both with reference, independent this blinded the important response Rozlytrek are population respectively. Phase Xalkori approved review in is overall XX% with of median duration months of given XX.X a data duration the with XX.X months it Xalkori compares of median to XX.X of published to which from for favorably patients, treatment the find treatment ranged encouraging we months. XX.X

Turning the safety preliminary profile.

As of patients of X X generally Phase XXXX the the total in study, repotrectinib XXX October cutoff and Phase of a in tolerated. date, XX, an was well portions data

In sharing an more cell addition half of TRIDENT-X enrollment in with update cohorts tumors. multiple X the to lung or cancer cell ongoing encouraging look our year. forward lung non-small recent TRIDENT-X, ROSX-positive within ROSX-positive solid TKI-naive this update. TRIDENT-X the I the to study now non-small early XXXX, TKI-pretreated data last we Phase the in data patients share We from second NTRK-positive from cancer August to in want study from other patients reported of

was First, cancer, Phase which with from lung and this based being designation now therapy potential position quarter, hope requested TKI-naïve In with the granted. ROSX-positive of plan to be cell reaching recent pleased to the in our be enrollment is discuss XX and FDA meeting. to X with next second during non-small discuss we pooled study. we B to in the a on following which registration X continue Type to the a one meeting path anticipate current breakthrough patients We Phase cohort patients our portions steps

in update provide of it NTRK-positive data cohorts of our and the study, is cohorts an enroll TRIDENT-X other it year. study the of the the to in to enrollment the goal clinical cohorts relates we TKI-pretreated ROSX-positive second continue half As to and in other the patients steadily and

our suppress KRAS-mutant mid-XXXX. continues initiation in AKT our to in the TRIDENT-X development study repotrectinib SRC which signaling, FAK, of JAKX, based the TRIDENT-X of planned This the to and towards planned Phase first mechanisms STATX of is of oncogenic resistance. of known believed is study make multiarm teams and addition on progress cohort our study, in to inhibition solid In tumors combination repotrectinib's Xb/X

design repotrectinib's an additional We present KRAS-mutant highlighting potential quarter. in initiation to data closer conference the will second further upcoming study in plan disease and details the preclinical of combination to at medical

as study advanced solid update alterations tumor TPX-XXXX, is population CSFXR genetic was our Phase harboring and inhibitor, early types MET,SRC in currently X in with pipeline reflected studied in represent MET. our in in heterogeneous a last data our patients being across clinical October. tumors MET-driven cancers Next SHIELD-X multiple ongoing

two there expand skipping we development for cancer, lung cell as as GI single now MET have to on approved we in mutations a While and the non-small exon as potential non-small to cancer, XXX combination tumors. and continue lung cell are of therapies the amplified XX well believe MET focus both agent

in we profile of of Additionally, XX improvement the given space, approved and two duration the room safety is response agents. there exon limited believe for the

safety a last how patients Phase across patient responses and our pharmacokinetics, in the reminder, efficacy with update a showed Phase multiple before generally objective heavily pretreated to evaluating The we for profile study characterize a safety X we continues those including multiple MET preliminary profile exon well-tolerated year skipping to a data X XX population. further are X doses As determining amplification and types recommended schedules and repotrectinib, to alterations. the approached dose tumor dose. with MET for enroll Similar Phase XXX

expansion quarter We in or we into select X with patient the Phase include selecting finding dose X the TKI-pretreated. are in population, which proceeding multiple the including who patients Phase SHIELD-X enrolling currently both dose Phase second directly TKI-naive in patients dose dose will the expansion recommended of portion X cohorts. after the The anticipate patient goal of are

this study therapy. data FDA program, an the have to Phase in updates EGFR of finding study initiation the second potentially year clinical targeted of dose pending additional multiple FDA X X portion of the study SHIELD-X, into from in our XXX the feedback including Phase portion planned a half We update of with the the initiating anticipated finally combination an registrational modify SHIELD-X our X/X design, and with Phase

Zai China, unmet There to latest cancer are of agreement need licensing in included develop for are our in gastric MET to Lastly, second that in the of particularly Similar repotrectinib, agreement want in world's signed highlight the our Greater for Lab. at China. advanced amplified January, rights diagnosed I and diagnosis. Lab commercialize time cases cancer we the in significant XX% XXX Zai agreement and where is often a to licensing with

In and to efficacy preliminary any data primarily inhibitor, safety on approximately XXXX signals multiple against profile. pipeline in schedules XX the across characterize focus this will provide type update. pharmacokinetics, and which further our our ongoing plan has a our efficacy preclinical in We evaluate mutations. data and study, quarter safety of demonstrated from to RET doses patients continue dose portion update multiple of We and the in early RET anticipate second doses is front to the XX patients. initial we Next wild RET to solvent TPX-XXXX. potency finding

be cancer approximately Lastly disease estimated of comprise billion in is of in candidate. approved globally non-small to were ALK-positive TPX-XXXX, drug Patients our approximately X% X% to fourth therapies lung our and sales pipeline cell XXXX. $X with

have significant repeat standard of gatekeeper we pretreated been observed cross several structure GXXXXR brain in currently after against compact in in current designed shown could the penetration are the compound inhibitors oral has LXXXXM ALK preclinically more patients. clinically resistant front macrocyclic vivo against with TKI solvent there to most barrier humans. tissue has TPX-XXXX great in potential sub-nanomolar approved, While potent TPX-XXXX including XXXX the Lorbrena mutations initially Yet, many potency is believe with is setting. considerably this mutation, common multiple potential supporting and mutation its studies dosing a and mutations. preclinical blood-brain in care

submit approval by our Ethics clinical quarter. Committee to the in the this to and second FDA the plan excited received We study month IND our are anticipate and to have later Australian Phase X/X initiating already

conference additional profile We also at look a medical second the forward to data the of quarter. highlighting preclinical presenting XXXX in

for financial call turn Yi over Now an let our the me update to on results.

Yi Larson

Athena. you Thank

earlier expenses will $XX.X and of and driven operating million by a see in in in to financial increase the was discovery personnel. quarter The expenses expenses release expenses. to R&D million pipeline million Increased attributable $XX our investments quarter in million made million fourth our develop the an in and increase fourth to $X were that totaled stage G&A the compared You XXXX. $XX.X tables in press for $XX increase we

by XXXX, XXXX. in increase $XXX.X and $XX was R&D $XX.X million to million expenses $XXX expenses million, million compared For G&A increase totaled The increase expenses. in million in operating driven $XX

activities. Excluding expenses discovery pipeline million investments million, of driven from year in in and third compensation during agreement The personnel. XX the we revenue This $XX earlier revenue our made cash by billion, first million the Zai partially develop December equivalents the of recorded stage October operating charge Recall, cash and quarter $XX.X XXXX, Greater million, during marketable a compared offset net and one-time May the Lab non-cash quarter used to from at offerings China. by December used in cash $XXX.X was primarily in stock operating follow-on respectively, for the of $X.X repotrectinib Net licensing million XXXX. from public by XX, and securities $XXX.X cash proceeds used driven totaled by our to increased stock-based non-GAAP as two $XXX.X during million. totaled $XX and in increase offset partially Cash, year.

Looking continue trials clinical now and ahead investments expect to XXXX, will initiate efforts. programs, stage year we during increase as new the earlier four we discovery our pipeline execute three across make in expenses to

to project XXXX. continue current cash into our We position funds operations

back turn I call Athena. the Now to will

Athena Countouriotis

XXXX, Thank for this the for To inhibitor. goals our novel you Yi. submission IND of anticipated with close, TPX-XXXX, our month, our summarize ALK I will beginning

a the registration and of XX in including in one with anticipated enrollment with have second towards We busy this of discussing steps next cohort population reaching expected FDA. quarter milestones, study the TRIDENT-X patients

clinical TPX-XXXX, for study initiating medical In the TPX-XXXX data addition, and X/X multiple at Phase conference. pipeline reporting interim presentations early

first including initiating of our of and a initiating your the combination mid-year, now the outlining anticipated providing SHIELD-X a focus Phase study SHIELD-X of enrollment the With to the clinical questions. in expect candidate. X the timeline clinical TRIDENT-X an we on strategy, and second study And portion we our update, the TRIDENT-X our ready and data the the combination in data from of to that and update Phase update finally to study. providing are study, cohort developing anticipate study, other cohorts portion initiate take Moving we X half, research to

our thanking Point by all close in and XXXX. team to growing Turning want accomplished they I great do, we Before for

to forward XXXX. in looking great another are open the line We for Operator, you may year questions. now

Operator

Schmidt Instructions]. ma'am, of [Operator Michael And have question please Guggenheim. ask your you question. your Sir, from first

is Your line now open.

Michael Schmidt

the just is terms of And maybe at enrolling repotrectinib Thanks a maybe like seeing your naïve? around more just pretty here. an of was well. Athena, what comment wondering guys. cohort what follow-up is I versus taking one you receiving am percentage that. you the enrolling in maybe I TKI as had approved I TRIDENT-X questions. quickly specifically you on could patients share market if if moment being actually ROSX It TKI-naive ROSX wondering and for on Hi your and study from experience seems the my then had could treatment are

Athena Countouriotis

I to Michael. am do so. Hi happy Yes.

market it commercial at a repotrectinib. its improved the I crizotinib cancer. of our cell internally a annual year-over-year. our And still said, the but our remains potential opportunity. obviously, X% say it's our at has in prepare to hopeful projections appear despite been modest the are to crizotinib very one for commercial leadership have least the well exceeded So initial that we that definitely as I our does launch non-small And launch, That relates the lung for very in landscape. belief in help trial, the for the market most that, is that approximately in Chief sales us with least the little large registration say for will ROSX United research now competition, enrollments Officer cohort campaign as gone Commercial year pleased us at change we and and said, That uptake of into of commercial care standard would there's to it modestly that is still that's States through appears a

So that's there. been very much why we focused have

as therapy as Type Of B to we course, there the now the quickly meeting breakthrough designation moving gotten FDA. we have and with can

Michael Schmidt

could any I upcoming to wondering data that address And the characteristics obviously X are we potential investors that RET RET inhibitors? against be just Thanks. should currently you mutations. front solvent have shortcomings will get terms the approved inhibitor, TPX-XXXX, activity potentially of Great. update other there? there in thinking And how then your about on if And was of interpreting Phase

Athena Countouriotis

XX We year design. essentially more against to other what relates wild the is has trial and to as solvent MET enrolling on are potent, been approximately have to doses on our the three-by-three consistently schedules. are today limited to have mention a XXX equally anticipate to clearly So on any been relates based have across we program consistent of to with preclinical additional solid mutations. it we try that mutation prevalence also front in two those that The enrolling XXX, information on of not type it the mutations multiple is the who patients mid-teens naïve. molecules to what is efficacy you again well that shown today at front standard studies TKI certain for continuing estimated TKI a will evaluate solvent important to been that as update. are signals point setting in the who as patients patients very only it pretreated Where specifically the said, but That similar well guide but is front and and really as mutations first update we early have focus did have we as we we of safety initial the predominantly saying But as doses. XX in

Michael Schmidt

you much. so Thank Great.

Operator

have Sir, your from question. Choi you ma'am, Sachs. please Paul next question ask Goldman And of your

line Your open. now is

Corinne Jenkins

is Jenkins, This Hi. on Corinne Paul. for

do and that your As days? is KRAS-mutant especially, solid where can hurdles the in of for talk studies development tumors, combination see of combination you repotrectinib there are about just program? clinical lot a you given these And you

Athena Countouriotis

us. for hello Hi Paul Corinne. to please And say Yes.

progress more this the gave thing not first that we combination initiation today little to only a been towards the been a is we to with So the sets trial. is, going have I be preclinical but developing very within trial. information highlight would making, repotrectinib, data have bit We multiarm around pleased say of we the been

cohort in the first this initiate year. middle the will of We

conference sure so in I the data anticipate to his. soon INDs that. and we that much have to coming much far at give more Our combination you our the a do I is am goal quarter, the GXXC trial of IND medical AMGXXX relates conference which we And to setting. support in we obviously it as is is, second don't relatively a typically enable think with to submit are too filed. in data But ultimately shown And guidance submitted have until design

in shown trametinib have data We the also with setting. GXXC

we relates what to to showing will think on relates as it it us of important too So think much the forerun to the without I it be as and partner will clinical hope be, response show talking we can design which combination trying and using for hurdle are to you what terms duration then rate, we anticipate we safety. in start

Corinne Jenkins

little like B key and think a conversation? And Type the would you Okay. be upcoming about to you the you That's get where fair. as questions talk bit can exiting then answered like meeting, would just about to that you

Athena Countouriotis

Yes.

meeting our is And patients population. in document TKI-naive our here diagnostic CMC outline the and And cohort of population. relates one it extensive try clinical patient Type component we one inevitably, focused for course meeting get requested pharmacology of to of guidance key our cohort to plans, while do was which our as and one is So designation. follow-up. is not briefing context the and because B this that have to think some companion potentially studies, regulatory an path meeting, number a that's ROSX clarify the pre-NDA exclusively therapy on preliminary the plans it's I breakthrough And

essentially guidance XX second mirror their you is the in we As initial current the entrectinib in we And patients patients that which crizotinib will know, application. had have designed and trial XX our to quarter.

meeting first since few So I conservative say hope is get that in there to be quite won't I having to trying been here have the answered. we a are this questions saying BTD.

information until of regulatory clarity pre NDA But meeting. point. terms you will can have receive preliminary do in a additional discussion very and as this you it's the be much think any helpful at I don't we obviously have So

Corinne Jenkins

Great. Thank you.

Jim Mazzola

Okay.

Next question, operator?

Operator

Yes. you, Thank sir.

open. Your next Wedbush question. is Sir, David Please of ask from Securities. line is your question Nierengarten you

David Nierengarten

taking a about Kind question. potential the previous little one a to of, here. as as combinations, maybe you just It's which when little have through Are is, I combination reach you mentioned looking of for and one, at KRAS, AMGXXX bit a look your for these Thanks multi-prong first potential expanding the of are priorities the you now? your trametinib. strategy to Thanks. two bit potential think that kind Hello. Are progressing curious, the what planning and from on you follow-up to a what let's wanted elaborate approach? you and then years am might about couple additional think eventually just sequencing looking of, studies, like at combinations? approval, medium-term you say, a if over

Athena Countouriotis

David. Hi Yes.

So let this me where just going to two because start year the with initiate is obviously combination studies. repotrectinib are we

for FAK The that trying potency to first take remarks, is again, in as advantage also and strong do suppress STATX which, I JAKX, of repotrectinib, the against fact SRC AKT and the prepared mentioned has it signaling.

data inhibitors. We more do what we but strategy inhibitors. GXXC our in data more We and hit goal setting much more MET other too publicly with KRAS trying here So not trametinib. What previously ways. again multiple we try AMGXXX a shown jump is is in other in do pathway resistance conference what have of bypass to far and GXXC to so with have we that's coming, combination data shown have the a coming have have to medical

initiation this is will determined. now, then pancreatic cell but sorry, The is occur our start potentially many all the determine. FDA solid part trial cancer down against of can't will be of too to trial I This again all initially setting. narrow and multiarm be and this middle right drugs KRAS-mutant be so still XXXX, in that to that approach. non-small lung and is cancer of to into that's colorectal and standard be our But give And trial pending will will a tumors are publicly in a practice. of I to much still more. kind we the am how filing And And it guiding

David Nierengarten

a fine. It's know. That's Thanks. I competitive space,

Operator

Matt Biegler your And line next of your question from Sir, is is open. Oppenheimer. ma'am,

question. You may ask your

Matt Biegler

taking my on. It's for I had a question going to back I eligibility. Thanks questions. SHIELD trial Hi. get inbounds one the

MET what of for I locations, copy did similar So capmatinib's have to amplified some we patients, think number recent data? seen you exclude

Athena Countouriotis

for No. the And question, Matt. thanks

fielding study SHIELD-X open So of a thanks MET The questions, just for that's as a X essentially all course. to Phase alterations. reminder, is trial

has so, cancer hepatocellular, GI But cancer, patients of including cancer. far the cell whether updates I enroll GYN with this by majority gastric multiple from are types, can it's as to continuing our non-small we we fall, tumors. you lung you tell last enrolled colorectal. And saw other have tumors,

exon it's to right fusion. course. irrespective amplification. of MET also it's open And open, mutations, to of gene number so kinase XX open copy And then for It's now domain

point dose, we and within will down As which select your narrow recommended number. expansion, are directly that time, Phase now move a is we to cohorts. gene may, anticipating the the at quarter X we into will towards X be the change move this into cutoff, second have copy Phase dose We the population criteria on to where patient

made determination sure, prior decrease but have not we that the will, of chemotherapy. for amount We yet,

four lung gave prior For prior had amplified enrolled patients patients initial like last three cancer that chemo were and/or but we or of median in the was the five update these the again rounds more fall, immunotherapy. therapies, that MET

will So no not that expansion. We patients copy from exclude the number. is your those gene potentially did patients the excluded now the But answer to question. are be on based

Matt Biegler

follow-up, may. I quick Great. a encouraging. That's if Maybe really just

about Just structure broad type macrocyclic something on you thinking about more focusing the think scaffolds to really type you of Do agnostic as you in more of TKI? Or being foresee future? on pipeline. the here or expanding any exclusively are

Athena Countouriotis

at future candidates. I at Officer, is macrocyclic initial development tell drug of for only targets is scaffold. not off been Scientific can all he also Chief came well that known evaluating our company our opportunities that The has this very other candidates follow-up. for minding four obviously, Thank you, when looking you for Siegfried, the but point, the

surprised our we idea we plan candidates. I first-in-class not macrocyclic different best-in-class the well that on with but evaluate highly as low also path lightly to weight and/or potent right to drug if to continuing potentially do be but I trying were maintain now, as down scaffold molecular of So go say would a would same

Matt Biegler

congrats Thanks and Athena progress. on the

Athena Countouriotis

much, very you Thank Matt.

Operator

Wells ma'am, Sir, Please is And your of question line your Abbott your have open. ask Fargo. you next question. from Nick

Nick Abbott

Hi. and very Good question a Maybe well afternoon thank you very for quick XXX. on a just much update. decked

You penetration you have indicated perhaps this think quarter X patients, on given it deck are this look asymptomatic could penetration brain the that see trial? with good molecule has and patients and a with kinds the allowing that you of you like go molecule those will brain more metastases. Phase CNS they for Do

Athena Countouriotis

I for and the you. thanks thing question, say Well, first of congratulations for Nick all. would one

which would XX-fold Let start. think that about I the our in more on and deck most somewhere pipeline. type than and when alectinib the it more am me because we the potent GXXXXR. standard It XXX-fold ways care. is in inhibitor you mirrors gen seen I many potent ALK of for have wild just TKIs look are not Equally, getting over I at only setting is potent you say excited what second XX corporate the repotrectinib very is the

So course, with a you and to what repotrectinib repotrectinib CNS story it's has penetration. again again, similar saw of

we quickly of the number the submitted. as through say as terms because design, trial skewed still, of it be will key or patient we fast all and but as We the IND. go the I will little into possible. to get if not specifically we single is information disease in is can discussion quite the patient CNS which patients much the course, initially. escalation as FDA will to slides, some to we on don't dose a see you know This direction escalation know too will bit we population down that yet got What try hoping of up don't I have of on type and So for are chemotherapy. goal of been TKIs to not. limit IND I that does prior But that in is use has a didn't

Nick Abbott

that And resistance. And treatment you. as of how anemia When just bearing down you combination do Thank PD-X two event and repotrectinib? think as they efficacy all part are a trying related JAKX Okay. adverse then and follow-up to see JAKX the the a And Grade about inhibits study, on related mediated relates to maybe X that. that to you question JAKX. fact there's it's the far

So is there interfere it a PD-X that be could concern combinations? potential perhaps potent and with

Athena Countouriotis

Yes.

First fair question. it's of all, a

first me to Let on maybe then can I the go back potency. the anemia step component and

we safety which of one with patients, set, remember, initial coming ALK So of from that data have thing a third And the about the showed X, our the of seen profile came half was from for we XXX X. about Phase Phase remember, pretreated heavily patients.

baseline, you and heavily look low anemia patients. we are sub-nanomolar came with only type were also course, have pretreated hemoglobin, When some the for in we of vitro So the potency that are at nanomolar. but in majority ROSX, of we for light had not were one JAKX about patients data ALK

is So ROSX incredibly a inhibitor, it but still potent. as as inhibitor, is as strong not a obviously JAKX it

have inhibitors translation JAKX being of in your prone will we unfortunately the the into So see point, terms clinic, of to to anemia.

Nick Abbott

you very Okay. much. Thank

Athena Countouriotis

Nick. Thanks

Operator

And ma'am, you have your next Partners. Zegbeh from Jallah ROTH Capital question of

line ask Your Please question. your open. is

Zegbeh Jallah

having other the initially on of to and Hi I Type wanted label then know of question. you you cohort wanted you really meeting? my B And expansion? time we minimum at The data NDA what the your But repotrectinib. just of XX talked follow would to good. think about kind updates to the I one are likely much just meeting? cohort have do start data be duration to will on guys. perhaps how the expect know time Thanks patients. with taking been of at follow-up then for an I the

Athena Countouriotis

Hi Zegbeh. Thanks for the question.

document are now. we the together briefing putting So

with it's safety can't what the I World too data follow-up. the a it as duration we NDA the FDA saying It's more seeing again, comfortable be you It than is not Lung. to totality. seen give and duration What profile to much get of slightly be relates from of rate, confidence So The follow-up. as where are information But will the of more closer really important do is, response feel interval, we for course, submission. will component. the overall important response follow-up, I

your predict the point first Type be with the indication of are will that to the where this enrolling will the will we going what some to question, be terms Regarding But other pleased extent, we at well. conversation we in have cohorts to way can't we in second dictated at because as go are frontline. by are B that we for

come. more to So

Of quarter meeting course, that pending we second and B the minutes, as is the give of guidance to outcome in will Type call.

Zegbeh Jallah

the at helpful question just XXXX, then Zai And how bit last Okay. been a from seem, they happen in sooner. then the terms TRIDENT-X? it across for has does And broad least perspective, improvement my little about partnership of is that

going I be was program? a lot wondering, So they with are to involved clinical just of more development that the

Athena Countouriotis

part the I was of My the office your Polycom my My XXX. as hear part here. in there a it team to the first first apologies, part. side second couldn't heard on But is Zegbeh. on question? I related

Zegbeh Jallah

Yes.

has Zai improvement was The just about for first of broad terms helpful so been TRIDENT-X part how far? in

Athena Countouriotis

Understood. you. Thank Okay.

announced the So that Lab they participating be half. and morning reported in TRIDENT-X will Zai this they in first

to obviously not initiate prepared in Greater that their us say market the us getting So China. they only the region and they that it been could the which more is what region, to would as have are helping helpful in I repotrectinib. within my That's what understand incredibly say I opinion in relates trial is experts

the XXX, think second You are in I that I your part. heard right

signed that we less But that with collaboration did they remembering right Zai originally initiation assets are when of within the XXX Lab, we first and signed was patient right in data. that earlier for You the had pipeline. other a

us it benefit cancer So encouraging, thought that would my be prevalence always if the given could the of was especially was that both. within collaboration MET that a that China, data gastric

has been she if way would on a I were to think recently, was speak clinical So the much how in that with that was here deliver. say, also to any with less And data. not call I one have also Samantha, that team I testament surprised she you seen signed was to it I think

So I faster of terms can collaborations. pace if additional much of predict too know I don't in

maintain we other for pipeline. the in worldwide course, assets Of rights the

Zegbeh Jallah

Thanks Athena.

Athena Countouriotis

Thanks Zegbeh.

Operator

question Please your Silvan ma'am, your Securities. have you ask [ph] of from next JPM And question. Türkcan you

now Your is line open.

Silvan Türkcan

more in multiarm And this? for? compounds a your Thank study us very repotrectinib similar I of taking for with for you on where could half much you the terms you year. couple that actually are of types you study also with Could EGFR setting of become objectives to EGFR congrats SHIELD-X, questions see a add TPX-XXXX the combination and combo, and my are Hi. you talked the initiating looking TRIDENT-X the second if tell about in what this also quarter. this the tumor with

Athena Countouriotis

thanks you first the JPM. are I for Well, know question. not at

You are at JMP.

So I gets sure that am done unfortunately quite often.

until And approach IND our my you. much for to standard is too by design filing IND Unfortunately, really submission. of FDA. practice it to give not Sorry prior the trial terms in

our segues guidance part you question study given clearance, of that more include of patient as will this in frontline, to who already or a we or they But terms gets the in again, are study that track to for unfortunately the think there be terms progressed using inhibitors whether initiation combination. yet. IND the also closer whether are in of potentials TKIs with given have EGFR yet. in we will bispecifics give just We and we to haven't design. your MET of I are right So haven't And multiple guidance second on that thoughts

Silvan Türkcan

combinations. Would And for and would they on these KRAS days to you with are combo. develop There out Thanks. then partnership? hypothetical multiple you way is KRAS question eventually or compounds? KRAS think strategy. it have think What there maybe just the multiple a do you of companies Okay. have multiple Or you a is the do What best do KRAS you side-by-side best want to with a one development strategy firm strategy?

Athena Countouriotis

trial just GXXC point that the of of is I setting shown be would data what will inhibitors. speak currently all our one to that we the have in inhibitor. we we say can Well, one commercially available are at I have course and saying publicly two the But is MET that this again, That's already now with preclinical which multiarm.

there repotrectinib that with. know you are So that we than will be one combining drug just more

not of there currently just yet We learned that do ahead pathway. different approach I are are with which. think be others is that different a probably to saying and lessons SHPXs us on taking potentially a

SHPX. are we course, Of targeting not

filed. the say JAKX, We about the really FAK. more But design trial are IND and SRC is once targeting to much

Jim Mazzola

Okay. Great.

I our now, think have question last operator. we

Operator

sir. Yes,

please question. have Canaccord. We of Ma'am, from last Arlinda your question our Lee ask

Your line open. is now

Arlinda Lee

there a guys. And Congrats the patients? when FDA on gating exactly are question, filing. looking have to with granted ahead Do what question naive that Considering, to they had be enroll the think you Thank from additional to on I am know do guys FDA need than dozen feedback? less patient you meeting. I But Hi want Or I think naive might worth are designation. conservative do chatting of you durability now their curious, stations? continuing think? And breakthrough think a your what I XX, patients of ROSX is is you. you a those saw you you maybe follow-up sites progress. them. for you

Athena Countouriotis

the heard What make me I Let part, Arlinda? last last I part. your sorry. was am sure

off. tailing were You

Something about enrollment?

Arlinda Lee

Yes. a continuing patients, naive to you Are TKI ROSX TKI-naïve patients? enroll

Athena Countouriotis

Sure. Okay.

to let So respond me the part. first

seen you and data and sample important. each bound hopefully the the recent had the last First to sizes, August most the specifically specifically have course from of of only have lower where as of come, at conference all, seven looking patients small that's the updates interval a of update, we tightening of it,

time, last breakthrough asked an designation six the B that's think of component same bring But have the I so us within therapy receiving a the important Type in FDA months. year, also to as FDA. just to at a background, December And meeting to

we the our pharmacology where the studies, just studies, overall clinical the of terms that and hepatic where of with our this with data. as course with patients. patient number than CMC, is the much DDI so with more Head includes, healthy now companion are where the our are discuss impairment we volunteer for are study, in us said, our really formulations, path. I And division to are of opportunity And of diagnostic we studies, we It's where

quite a patients. pooling Phase and C remember, agency of and from we a is feedback X we end pretreated get more with on last focused because the at had to Phase there X which this Type meeting follow-up an of bit August, was point, and and have initial So Phase meeting the had X

So more we this much had conversation are we of hopefully level going that before. have is than

And so it's than of an the important patients more of meeting, number duration it's response. just much or

key to half that's guidance for today, of have with relates support difference follow-up, which guidance, understand minimum really from us given the approximately important the to question is approval. a is timeline, it there XX to the NDA is responder any prior last that months patients standard just XX the of they As

much So of just that's us emerging et is there cetera. try number to on patients, of based well bigger it's a meeting difference question to a than key our data. there response, if for as discussing understand duration any But

Arlinda Lee

the Great. enrollment naive? enroll That's of, And continuing to on helpful. super then

Athena Countouriotis

answer I am apologies. am sorry. I that. My didn't sorry. Yes, I

actually had in mentioned I January, So XX patients. we

And we we coming Lab will we getting cohort our recently one. that at enroll had the to partner patients, close quarter patients, continue We TKI-naive I especially who have will get obviously patients. anticipate XX trial into we a that to to after are we completion Zai in in help XX enrollment also the to are time second guided the even benefit have said within where

all at and approvals, of So the the enroll. follow-up patients approved precedent two inhibitors And those well the agency inhibitors letters. to RET we five more of of that the as required important were more their there approval context MET approved also the will, yes, with that's if look you all continue and in two Rozlytrek, as

that we so be will will also And something mirror.

Arlinda Lee

very you Thank much.

Athena Countouriotis

Arlinda. Thanks

Operator

it would this question for call. speakers, And so be last our

to over back Turning Athena. Ms.

Athena Countouriotis

Thank just interest and and of will And can't to everybody office. for to you you dialing families all I face-to-face you I the very your the to of of see for happy of call. Turning in much, operator. that you of many Operator, I support personally, employees remain the stay continue in was very all course Thank and Therapeutics. your Point I today incredibly in much. you to say, hope today now close safe you hopefully our wait may near-term. see Thank and well.

Operator

you. and this all today's gentlemen, call. Thank concludes conference you Ladies Thank joining. for

disconnect. You may now

Turning Point Therapeutics (TPTX) 2 Mar 212020 Q4 Earnings call transcript