TPTX - Earnings call transcript Q2 2021 | Turning Point Therapeutics, Inc.

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Operator

Thank you all for standing by, and welcome to the Turning Point Therapeutics Second Quarter 2021 Conference Call. At this time, all participants are in a listen-only mode. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]. I would now like to hand the conference over to your speaker today, Jim Mazzola, Head of Investor Relations. ahead. go Please

Jim Mazzola

And you. everyone. Okay. good Thank afternoon,

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

investor also presentation. We our updated

over of turning You may posted Executive Paolo Point's for the update documents to an find Officer, Turning our the Dr. today be results, and who of tptherapeutics.com. will our overview Chief Investor will provide our on call President Financial Leading review the a these call financials. pages before Chief Athena business Tombesi, Countouriotis, and Officer, of

We our will following Chief remarks. prepared Hirmand, be Officer. And we'll take questions Medical Mohammad joined by our

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

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

turn Now let the Athena. me to over update

Athena Countouriotis

you, to we organizations, pipeline. I good experience our brings commercial us financial hired joined critical be is CFO, joining afternoon current Mohammad newly by tremendous everyone And pleased to call. Paolo, am supporting today's advance who on our which as Thank Jim. and

number forward our of Our two candidates. stage genetic sharing FDA Since and we to the today work development information tyrosine our inhibitors next bringing our with in the make last employees our advance of new cancer, ongoing look and additional our from about quarterly initial excellent to received study target trial clinical growing total Turning studies to we in regulatory milestones now Overall, TPX-XXXX potentially clinical discovery candidate to designations XXXX. Point update, fourth initiations XXX has continue TPX-XXXX, began of progress I that anticipated second ongoing generation our important FORGE-X kinase and continued team four timelines drivers half. more than to our for planned five against two for many clinical dosing of have

as As always, non-small TKI track non-small patients and in with lung positive ROSX breakthrough our patients Repotrectinib therapy designation will which repotrectinib, lung TKI with advanced with TKI is TRIDENT-X TKI positive, patients pretreated NTRK and cell non-small cancer for ROSX and registrational our fast cancer with study program, positive designations start patients multi-cohort as being well lung currently I a NTRK positive for naïve and naïve solid cell generation next ROSX TRK three in lead advanced studied pretreated ongoing ROSX cell is cancer. tumors.

I approximately the of portion includes approximately in cancer week, and of positive XX study II As EXP-X. TRIDENT-X ROSX the cohort, XXX enrolled TKI the of have combined Phase non-small last cell we study. lung This Phase and than the naïve in patients in more now the II total XXX patients portions or advanced

milestones partners of patients triggered continued which to We we recognized momentum and initial study strong across and TRIDENT-X $X based enrollment were to five reached June, within quarter. continued continued in have and cohorts target we provide million, enroll Lab pleased additional cohort have on in enrollment dose China. in the to our the In treatment our second this patients. patients in to access EXP-X new see in all steady Zai we This

quarter guidance plan meeting. the at in completion potential six continue to of with when of We the have announced B meeting plan we FDA based we the a from blinded followed for EXP-X FDA onset review independent from anticipate months further of FDA, provide upon registration first least past to the top discuss the on Type feedback responders central results which quarter, with we on As response, timeline been last the to line XXXX.

conference half Turning and ROSX assessment October. we NTRK AACR-NCI-EORTC clinical to by cohorts update, annual the anticipate physician early TRIDENT-X updated at data providing second multiple across in currently data efficacy

We patients. in expect other better next the also at this update we cohorts at XXX And TRIDENT-X from ANE provide be a EXP-X. will time, position that to data meeting steps include will safety on beyond approximately

Our additional for studies repotrectinib development beyond includes TRIDENT-X. plan two

ALK I/II The NTRK advanced in first harboring is adult our malignancies Phase pediatric CARE and ROSX, young study patients with or alterations.

our International We has data Oncology Society presentation this the are pleased oral clinical at first Conference of for been Pediatric accepted that October.

trametinib, pharmacokinetics GXXD study The mutated of combination potential and TRIDENT-X tumors quarter. we signals the Ib/II study Phase add solid to to advanced examine efficacy initiate combination safety, additional with our study over cohorts time. early is of and the patients in any the tolerability, to plan which of the second third The repotrectinib TRIDENT-X in KRAS will with

Next being with advanced solid patients our in our pipeline inhibitor, MET, in I genetic SRC and is SHIELD-X in alterations studied CSFXR TPX-XXXX, MET. Phase ongoing our study in currently harboring tumors

TPX-XXXX including patients adenocarcinoma. gastric for junction we cancer, the orphan for designation During with gastroesophageal received quarter, drug

week, TPX-XXXX received last track designation for just addition, after chemotherapy. gastroesophageal cancer patients we prior metastatic junction for or advanced MET-amplified adenocarcinoma In with or fast gastric

responses XX then, well likely non-small This is are heavily patient have multiple And Phase across pretreated currently We across lung and refined, a a well and exon recommended based safety to the selected non-small cancer. within on data, I for multiple Phase both cancer. an SHIELD-X important data dose with dose treated cell cohorts. will be enrollment safety lung II population. in first have PK, have different indications, dosing XX, tumor less enrolled tolerated showed pretreated including began therapies XXX As into generally XX MET-amplified opportunities the we cell gastric TPX-XXXX there MET-targeted further expansion. several in we as cancer profile heavily types patients program continued and with preliminary reminder, differentiate on as our approved populations now no the the an objective patient type, the fall, as including patients in MET-amplified cohorts tumor based believe Since individual a available cancer. Last dosing preliminary and milestone for MET-amplified gastric in exon gastric and our efficacy we

the for the I end-of-Phase to a I/II FDA quarter. Phase meeting feedback study into study. Phase with pending FDA an the preparing of agreement II revise potentially And is registrational recommended goal are proceed the and We our the SHIELD-X II into on portion dose, including Phase this multi-cohort

proposed design plan on non-small XX MET, Our to similar Phase treatment including cell dose gastric the and focuses ongoing details meeting. skipping of pretreated, Phase and and II non-small after lung populations, and We which naive to cancer, is cancer. on the II exon Phase main end study currently patient I more cell lung design cancer FDA and is feedback expansion, four Phase both share both the I MET-amplified the

efficacy regarding We preliminary dose. provide supporting we our at types and meeting XXX, Phase plan initiation portion Phase filed. IND in dose update clinical of recommended providing for also continue multiple from this of SHIELD-X the data will In therapy an I addition our to once anticipate across data PK, a October, update finding in guidance of patients the the Last, anticipate update alterations to II the the TRIDENT-X study tumor combination later details ANE year. to our EGFR we with safety This is on study. with data the MET focus targeted study

be being in The with patients Next determining SWORD-X fusion are I to recommended I/II studied our study advanced ongoing efficacy in in tumors pharmacokinetics, of Phase Phase our finding or and dose doses we to safety to further pipeline inhibitor, the continues patients RET the determined mutation is solid enroll before Phase currently and profile RET portion SWORD-X TPX-XXXX, our where dose. evaluating schedules II multiple positive. characterize

data inhibitor, I/II will plans Australia. US enrolling study We currently additional where our the sites Phase our and program from in FORGE-X is for outline XXXX. actively ALK update in in we our the Last this TPX-XXXX, CNS-penetrant is and pipeline are next opening early

tumor XXXX potent array advance vivo was We preclinically, highly gatekeeper front the XXXX than are had is ALK harboring models front a compound have Molecular solvent and cellular regression in wide is mutation, ALK published we of in Against selective seen and substantially recently mutations. potency both inhibitor models. cellular solvent the xenograft harboring tumor which an harbors excited higher therapies. GXXXXR dependent XXXX complete which targeted mutation that vivo mutation studies, ALK GXXXXR, TPX-XXXX compound Therapeutics. approved LXXXXM In tumor model, the given in and Cancer in a in activity to demonstrated

has Shifting there design focus and to drug development, advance ALK Point's programs often core been now, differentiated Since clinical several make This inhibitors believe potent mutations. potential structure our progress could patients small or oncology. us in While advancing with towards pretreated great has into precision have are discovery in based currently lead registrational XXXX highly the expertise TKR candidates deep company the initially in now anchored to continue discovery enabled be approved, to all successfully founded, ALK molecules. approach an our leader are compound directed our vision Turning single ongoing study. to the we investments develop and by asset methodology deliver we who was four in

goal I timeline the pursuing that can two a IND is at our potential candidates. will support future every forward, Moving research share is XXXX. least portfolio and four in team targets of our Today, discovery beginning development year to one new our

in new selecting targets following begins the focus with Our criteria.

medical need areas First, of unmet high addressing for patients.

structure-based and deep our expertise leveraging drug Second, fragment design. in

And finally, GTPase play market of fully platform, cocrystal providing new need. the strength guide established to an the genomically and Each Third, that signaling programs cancers biology target. drive medical large opportunity. significant prospectively to of known underpinned potential four the designs. protein structural a with been real activity our enabled unmet targets in around is structures program used time with defined roles supporting the Each have aberrant ligand

as We initial are first-in-class oncology. on I within focused share two information validated most both advanced on programs. as opportunities will targets, Today, novel the well

modulating KRAS present GXXD. KRAS cancers is The approximately attractive target RAF/RAF/MET Mutant targets an therapeutic first its for and in all pathways. program of is XX% role signaling in

While high and approved an few tumor have non-small types, an therapy there multiple And is very cell in lung cancers. unmet need of medical remains GXXD there pancreatic, space. it Lumakras, in in the KRAS-GXXC advances colon including been now area

to goal second candidate the half Our nominate development in XXXX. a is of

breast key targets target ovarian and opportunity a of with of selective the PAK multi-tumor melanoma and are non-small nodes cancers, kinase represents PAKX, in which This program family. pXX cell inhibitor a and PAKX second subsets cancer. lung Our the activated signaling or

to this which is and single a goal potential of amplified program in combination. has and we as agent differentiate believe inhibition with PAKX PAKX, dual Our

more we are forums. We a by in Overall, of future look half for these XXXX development program. medical forward in excited programs sharing to this are early and pipeline investor candidate detail targeting also second the and

update to call turn provide over results. financial to Now Paolo the let me an on our

Paolo Tombesi

of many meeting I'm to in months. Thank excited you and company Athena. look to the you, the join coming forward

driven of You will Greater $XX.X Lab was licensing see totaled in financials revenue R&D agreement increase in million our and XXXX. in XXXX. $XX.X from of for repotrectinib $XX.X our generated in mainly second million the by compared the half that $X.X China. expenses. to and $XXX.X to development first we in increase milestones for $XX.X to the related million $X.X million during first quarter $XX.X million tables increase Zai million press The the G&A release compared the Operating for quarter, million expenses second Operating for earned quarter half under expenses totaled expenses million in

$XX.X increased one-time, million, growth charge our first the first operating a G&A compensation the Excluding expenses quarter half by for stock R&D of in and in expenses. XXXX, in XXXX of driven investment by non-cash increased based

totaled will continue cash continue we Net to invest clinical billion. XXXX used $XX.X additional marketable the as expect to with agreement during Zai June half two the XX from offsetting increase at discovery cash the in of five used. cash $X.X trials clinical first generated securities across equivalents execute our totaled programs. revenue expenses partially initiated the now Cash, and during the million, year Lab We and trials, approximately

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

me Athena. turn the let to call back Now,

Athena Countouriotis

goals To the for will of our Paolo. you, half XXXX. close, summarize second Thank I

assessment physician in repotrectinib, October. for to TRIDENT-X NTRK ANE by conference forward updated providing and First, multiple the clinical patient ROSX from cohorts at look we data

the addition, Phase initial CARE I/II study at In October. report Congress we patients the to clinical data in in plan pediatric from and ongoing adult SIOP young

MET to For patients the data I conference Phase also ANE tumor with TPX-XXXX, the from multiple clinical we portion of across SHIELD-X finding plan in dose a the at types update study. alterations provide

including to of our combination from across we portion update, planned the continuing initiate to feedback plan closer pending these as ongoing trials, forward progress questions. clinical Phase also now Ib/II plans study data in that Operator, the are and more next With early We line and initiate to II Phase FDA ready we'll SWORD-X outline lastly, study. we to the discovery studies we to you our XXXX. additional targeted look And XXXX SHIELD-X questions. the with of candidate our excited EGFR therapies. the our work your study TPX-XXXX SHIELD-X And sharing and an for studies in look forward updates We TRIDENT-X and in for may get nominations. to now open are continue take FORGE-X

Operator

Instructions]. [Operator

We have our from Choi first Sachs. with Paul coming line of the question Goldman

Paul Choi

questions the on Congrats all on progress. of Couple SHIELD-X.

you a and of are I TPX-XXXX, is press dose of I the mentioned your patients found release portion enrolling here. schedules are levels Or you enrolling the you First, ask, expansion going confidence across think your with dose that regard the enrolling But only you right dose? that the patients what II is here. in to different dosing this at still here? to was are patients measure you guess recommended you in Phase

Athena Countouriotis

me question that let Yeah, to pass Hirmand. Mohammad

Mohammad Hirmand

the portion For I Phase likely the enrolling of patients the at we dose. recommended are II Phase study, expansion

plan upcoming have of Phase that where As I to us with agency study. dose II with our portion we recommended an them to the Phase initiating meeting discuss end-of-Phase sure prior the to Athena mentioned, make we aligned II they're the

Paul Choi

in the will to Just upcoming you appropriate? have numbers a of And your as with from maybe about the you meeting? it's types about us tumor position a help think regard what be copy gene follow-up, the update can amplification, talk you at mix might where program, triple to

Mohammad Hirmand

can I also follow response well. on Paul, that as

in So, Phase October update again, the data ACR-NCI-EORTC going October I finding portion. the at meeting, from is the to in dose be

As we across enrolled genetic and recall, you MET doses. of a various across types alterations may patients number tumor

be to the So, going data we're that's presenting.

as data efficacy on As bring much the is and as safety focus But now. that we of PK, be mostly Athena right RPXD. to data mentioned, to going supporting can primary try we'll

we that acceptance. recently were notified So, just of

So, right have so we that of in pieces terms for the now, time stages together, we're in in planning the the putting data delivered presentation. can

Operator

with next line Michael our question of the from coming have Guggenheim. We Schmidt

Michael Schmidt

about market to MET XX you to but how Congrats on are nice initiate indications, directed approval hear exon I updates cancer, those any registration should well. non-small enroll in we in on inhibitors potentially guess other you're following cohorts cell cancers especially I as these XXX, the Phase a for bar study different the that the study? to II given not guess, planning lung meeting. are that think the the of already on for planning that enrolling the or FDA

Athena Countouriotis

MET know, XX had you approved therapy. the that regimen have you're course, that's as patients have or referring MET seen to, first and platinum-based no a So, in exon of inhibitor chemotherapy in

than less is we that what in have is exploring right as populations where this much dosing. lung expansion we're SHIELD-X cohorts, earlier, as we've multiple few know, we well XX as you therapy And to well down focused And slightly now patient on the But received As we the we dose happy now in refine as started second it that gastric designation. MET-amplified indications. said Obviously, dose a exon happy cancer. finding. as our allowed very

terms of bar, you In one approval has the accelerated the approval. therapy approved know, as

targeted differentiate, can But gastric that So, terms benchmark it's therapy. in MET to we think cancer, what go clearly, we about necessarily of approved no against. ways a not there's amplified

I meeting we'll the for would the as are Mohammad is to now. And meeting. we chemotherapy. said, planned now in looking of So, But likely he's against the of preparing these context feedback third that that quarter. kinds more within And the benchmarked be be forward conversations end-of-Phase

Michael Schmidt

upcoming TRIDENT-X update, on your study. follow-up the quick well on as a Just

mentioned patients the Or you this will is more data now those tracking well are one study? in cohorts in the II enrolled cohorts? Phase include in I cohorts portion. it enrollment think completing guess, how the towards triple meeting? XXX I you the you Will as that on? geared towards which cohort at other provide And

Mohammad Hirmand

with I as have we has Again, going been take that question TRIDENT-X. quite in how can been well. enrollment pleased

the across enrollment We have cohorts. steady seen all

in Phase have of XXX enrolled II about study. the remarks, the mentioned opening XXX patients Phase in I, about in portion Athena her approximately study, the in total XXX we As now in

data ROSX anticipating now, the again right Regarding in enrolled multiple approximately meeting, report that the with assessment and patients XXX triple TRK by safety, we're at the data in October, updates, on to TRIDENT-X. physician have cohorts from coming again, we

Operator

from coming with We Biegler Matt our Oppenheimer. line the next have question of

Matt Biegler

the jump versus cut, expecting focus the we are Or than Should TRIDENT-X which update be XXX. kind at had a pretty patients NTRK before? here, seems just thinking how amongst on was, gun but Don't a want increase we last breakdown to you XXX I on patients our cohorts? substantial larger think, about like the of

Athena Countouriotis

with second obviously, me pandemic a all We an here said, been I what it amazing to a as the cohorts. am I take had think difficult, with challenging to the very team consistently proud continuing study. of let we've And TRIDENT-X say has against strongest has Maybe just, time, believe, our how such relates actually the The been team. steadily I of enrollments the job as enrollment across cohort. done enrolling I've

you'll too from since to cohorts. much see. say to And we And we at in update said, That last front been they've multiple it's as been the NTRK a said, the so, making. incredibly But And and don't of today us same while Mohammad run what I'm it's the proud did give progress time, normally our regards August. ROSX premature again, abstracts. for last

informed And data. of So, forward would week. sharing course, that I we just into specifics, more say look just the were without last to going we

Michael Schmidt

of just amongst trial. the to the how last thought that I your patients in was diseases too We quick SHIELD-X kind mutant the a thoughts Maybe EGFR are MET to different I see with just that the just or follow-up activity those whether wanted you're might it planning portend on amplified two cohort meaningfully. one explore really to on nice readout. can extrapolate the to

Athena Countouriotis

that similar the and been data that the in targeted setting, and you've come They therapies. MET have approved an inhibitor are combination sense with approaches the the with has the combinations seen that in taken obviously, EGFR specifically,

And lead asset one agents Our the goal planning. as our combinations, our repotrectinib, both single those combination pursue combinations. and to as EGFR second as as of well we're in that is highlighted, you in XXX is asset, both

in update while one, there the go the data patients didn't in are that you'll think, have information addition, we for that combo I see IND into forward as when hopefully submitted we more And would EGFR cancer filed. second in is inevitably initiating of prior the specifics, normally look will end to that data and the give for half, the more Mohammad lung to year still update. we an

the for combo. And that's EGFR plan now the so, right

Operator

have next line coming of We Securities. question our the Wedbush with David from Nierengarten

David Nierengarten

couple ones. a quick Just

other a You've till question with means as just agent ongoing data any will have mentioned is of part meeting assume and time collection review we over another planning physician if triple focusing then, the the the waiting combo combo Lumakras for times or up couple that studies was you I guys next repo, curious now be of that that on blinded that central running? for you on approved, were the assessments repotrectinib. year at I there. And

Athena Countouriotis

independent want review to assessment information the central context the then next agency for FDA that come feedback. the which physician specifically we've QX ANE yet meeting said because for the with in think seen to discuss to goal had data, presentations. our anyone said not have that with consistently that and of data inevitably of we've in the the FDA is didn't year time in We've would we the We've blinded we public

So, are the as trial. with know don't the current how of point. now. as currently in is combination from will yes, that's a remarks, sorry, multiple based GXXC for I Lumakras this on addition what to prepared anticipating that right BICR more I at for in are, concern, the I least I the dosing relates first of say, combination have the required the we to said the regards capsule of Lumakras. daily specifically somewhat at can burden some into data said my be our And approval cohorts feasibility capsules many side inhibitor, times

XXXX. in first with so, of start arm much trial trametinib, And may we quarter. GXXC course, initiating But that forward very this terms to into of a look arm the

Operator

We have our the of Andrew Berens line next with question from coming SVB Leerink.

Andrew Berens

agent. XXX MET dosing the to A as similar portion minimize a like couple have the escalation dizziness It dose repo. if on sounds for

on And then, you of other wondering are escape us some or an what's And considering from be be drugs number the copy with you've large then Just chosen lastly, molecule thought molecules? to drugs, MET combo with could you combination color MET EGFR amplification? you give that. would if that mutation? And that mentioned the small is classes

Athena Countouriotis

relates XXX. Let me to take it as

lens the – filed. we have too few normally taken quite additional looked the done for has in since give get So, Phase the well I approach, information evaluating But question program, presentation outline predominantly really And we to that an as consistently, cohorts, think doses, for focused II dosing. until We we been and we IND more did recommended we've will a to session follow using an we've likely XX plenary as in you titrations. today at And XX BID and of is, combination feedback dosing multiple repotrectinib our is saw, around whether or FDA's our flat potentials. why I've regards information we MET that much QD we wait until milligrams, on year don't mentioned, initiation, is this on it to in in exploring dosing where hear said with dose last today, point the which our but managing as milligrams dosing at closer have The titration there. are essentially Paul's our again, a you're corporate to much to confidence as safety, in that EGFR, with approach. of you been regards

at mutation number And trial. And question say evaluate to in we've SHIELD approved gene looking as and that the point ongoing inclusion using program collaborations tyrosine are to we that and/or of Tagrisso would copy so, we're I escape agents been kinase high at well. your antibodies both include the like inhibitors, just including other gene low copy continuing in gene is where number, this with copy number could

Andrew Berens

Are you other programs, than [indiscernible] mutation? or EGFR, considering escape KRAS other MET

Athena Countouriotis

We at earlier at preliminary on at that an we year, were looking initially, some this based combo. data IO shared AACR

And something would just the hopefully, so, XXX I And continuing evaluate. share is over say that the lifecycle to we'll planning program more currently we're for that time.

Operator

next the from Capital. our of with have line We Jallah coming question Zegbeh ROTH

Zegbeh Jallah

I follow-ups asked. just that question of have has a been a few

for I we've expectations is NTRK think ROSX. about the so focused on first because been just

So, you expectations the the can how thinking and for that the what are pediatric do data just you're about as opportunity, well. probably same wondering

Athena Countouriotis

you think is that said Did expectations, I right, you Zegbeh? say expectations?

Zegbeh Jallah

the And how that? market you are opportunity, about thinking Exactly.

Athena Countouriotis

in we regards just the second me what updates. half said today to start with Let

clinical said, that still October. a presentations already three is Mohammad excited the meeting in ANE, of heard, virtual meeting. we've coming As And haven't virtual we're we unfortunately, now heard have that those for

for we're And our so, TRIDENT-X video least program. a well then five for to I looking is an presentation at oral both this as minutes at forward pediatric SHIELD-X and believe, time, as preliminary, what presentation

the TRIDENT-X for we would ROSX multiple what said question to your NTRK and give was update we cohorts that Now, TRK. including

we with We lag pretreated the enrollment And expectations, that TRIDENT-X. the behind said way of consistently population. regards update. TRK Obviously, we've pretreated has actually to in little that in TRK a always have designation with patients. But for TRK knew pleased committed with naive across gone naive I've been Zai TRK So, the cohorts Lab, we been track to cohort. the steady recent pleased also said, may addition have the we've fast the a enrollment

the more expectations my limited it more market of being the well. opportunity, terms competition, as to well TRK approved our rates that I monitor as potentially relates is NTRK. From doing. we the current have a data helping increasing as so, course, in approved as we'll But information clinical continuing think, obviously, in we're share to how perspective, commercial that with the to is second as half landscape currently And inhibitor testing of tests,

Zegbeh Jallah

just you as on the comment data Can well? pediatric

Athena Countouriotis

The allows patients either driven as and known to now are unfortunately, pediatric which NTRK. tumor pediatric certain patients that types, a reminder, just of this be positive, ROSX in trial ALK ROSX in expectations, positive, are

to is pleased so, in oral anticipate it presentation. and that regards for first again, mix accepted update. And But to is from what that an it this was update a our clinical

Zegbeh Jallah

Just another follow-up here.

cohorts are you to heard think cohorts mention those for wondering what looking those be, I I the just combo, KRAS I'm initiate what might for you cohorts? additional

Athena Countouriotis

now point, with initially this again, At right in on data with just we've shown pill been AMG-XXX. the GXXD focused the potentially because based past as preclinical GXXC, been trametinib, well combination XXXX as with simply mentioned, in on burden the I we've as we've very pleased

any of so that have be combination arms terms to the information to come. more would in disclosed additional haven't We yet,

Zegbeh Jallah

Just two more here.

regarding The MET first is the program. just

is MET initiating not if wondering first FDA the the related? you're Just to combo, before that with going meet or even

Jim Mazzola

target combination in to MET? Are FDA meet EGFR that before with initiating going therapy with

Athena Countouriotis

plan, current an our with we combination, with XXX. just and EGFR is trametinib, because IND repotrectinib is the to submit combination a did Zegbeh, as this

then Of course, I right now right more go our disclose and the end-of-Phase the hopefully to focused likely regards dose. you goal would to to submission the II information IND is then We filed. in into on meeting IND recommended being our Phase

So, a but a new not require would submission. IND it meeting, necessarily

Zegbeh Jallah

was two that and you because do mentioned could important just combos And the for was here, just and patients the about the what do about so I how combos programs. we're one excited that? last the I was expanding wondering, pipeline, just wondering, market opportunity, Then potential as with to thinking you're

Athena Countouriotis

combinations. a you the the in would made specifically activated pXX about with highlighting the for kinase, was progress is me space at combination would general, sharing call, opportunity of We idea I of do things it we've the our did the the I just with we least for of discovery Thank believe on the GXXD within a quarterly Arlinda, One inhibitor. group. now or say in last say excitement, the asked PAK, combinations. And GXXD

second the may of new This in But single just new information course, goal additional, regards We our bit arm first would targets. that at I or say have, of stay So trials two one in of forward. development combinations. agents, of look just IND include least but half And the single may with starting only hopefully, our now we to that tuned. out we're XXXX. is coming in candidates terms not that not of there also put sharing just we've XXXX

Zegbeh Jallah

Congrats and to on in progress. you always team pleased so the with coming late all with so questions. I Unfortunately, many you coming. and queue the am your

you. thank So

Operator

[Operator Instructions].

our the question of Silvan coming from JMP have Securities. line with We next Turkcan

Silvan Turkcan

Congrats and on progress. great the the quarter

to potentially Looking Could describe I data. hurdles discuss are transforming what please if there the question. SHIELD-X left. a with the there will regarding into FDA, you that registrational a have all forward quick are any study you

Mohammad Hirmand

one. look upcoming Again, have have in I FDA quite can the XXX we been meeting. the program the take regarding and made to that excited forward progress we

what during the that like meeting, would end-of-Phase number by items. So, a is FDA we I run to of

II sure them dose. recommended is, of with making Phase they're obviously, our aligned One

our separate move additional to into under same that trial, may regarding want the umbrella, study a modify can obviously a Phase do we like the also as I to from Phase doing that we is so which what II study to And into I/II thing one We startup protocol to protocol actually basically would II talk Phase Phase to time. look them opposed like. existing a study, takes

meeting, come in of you. kind approach that's how once with share and trying that then, the obviously, we conceptually So, FDA hand, minutes with have will And it. we're the back we to

Silvan Turkcan

I/II pediatric different anything in study, adults? that you oral CARE data fundamentally congrats TRK targeting? us the tell presentation. on [indiscernible] same less or of in Phase or that your the presentation it About may as biology alter the a is the the Could tumors is KRAS these response more tumors Or or as

Athena Countouriotis

adults. of less The trained tolerability I'll children in because et Really, say pediatrics, thinking just than one would thing cetera, interesting, I Interestingly enough, better just have oftentimes is about comorbidities, that, I agents. it's quite Silvan. take

because bigger, what weight, things the relatively based TRK prior dose, the see well the a ROSX modifying fibrosarcomas driven to is mindful infantile more mgs program, as the very frequent, or in weight of of we like adult is then, as twice tumor are been inhibitors, which pediatric from types unfortunate as of one daily population on dosing component, exception within obviously, TRK some get so, with that going either flat appreciate, are dosing based using especially But approach. we've can biology glioblastomas. XXX have of And often is unfortunately, a you And children we driven. the the

in the And ROSX looking so, we'll you focused extent, forward to But least course, in at clinical there tumor is of the cancer. as this to which Again, that some not said, have the data unique is more from update our types update. much more population, program, may are, in seen have adult I the lung program. first

Operator

with have Canaccord. We line our Arlinda from the question of Lee coming last

Arlinda Lee

can inhibitor? target you Are your to use What's talk do targets? pipeline going then, One, macrocyclic you progress. you looking you these stick the targets trying in about your you billion secondly, had with inhibiting to intend the what on I or at And how and philosophy addressing cash earlier philosophy cash. to $X.X two. resistance the can versus with provide of emergence combinations? color on additional have Congratulations you're and that on

just situation. it'll you're studies has low. go Your you as about burn quite your how combination increase about thinking your been curious in others. cash Obviously, up But

Athena Countouriotis

week later you with time at some your spend well to excited as conference. I'm this

take component So, pipeline first. let me the

you've perspective, department, rest One obviously, our when and investment we headcount then organization. specifically, could in a but board, line the opportunity. risky, of well as might this in potentially potentially validated two validated GXXD, a that repotrectinib assets hopefully, philosophy what have, that our little best-in-class said potentially today larger Turning and department, discovery. biology still our you now and top a the bit is within ways is, targets, our of a advisory Point of components with we I further first, met ways, expertise when company such less be we as our pipeline, was, just as private is really with me more look be which in to our develop could chemistry where scientific first-in-class we at largest And from first seen things one a The from of our DMPK group, is think as

are been those approaches the the that So, team taking. have two

You know is than assets, appropriate that with of course, scaffold stage that there and repotrectinib the our of foundation is others. clinical the four macrocyclic platform targets current trial, a registration in may more be where

we it's go so, that evaluating further. something And as currently we're

assets first our current as, stage opportunities, on treatment that even that staying resistance relates obviously, repotrectinib, program. also more treatment potentially there pipeline and are more focused it line our within others but resistance, such are clearly, focused clinical As on are, to MET within

our of at criteria, versus as in in can't outlined that's clear have the And that area target the in product focused my that we And sticking view one Arlinda. that as profile of apologies, we're a course, absolutely the so, as point remarks, very keeps I our a My general market resistance medical forefront biology prepared I we're of combinations. in terms to selection say well But expertise in-house, on our need opportunities. that and then, philosophy.

pushing platform. of The advance cash cash, use, which to into on using the to XXXX. course, well billion takes we as assets, going terms to critical In our us cash been, plan we discovery it at use. our as our is use to And relates as have how continue forward cash stage we're continuing as $X.X of our

Operator

Countouriotis call closing Athena are There the now no any for you. to back will this at time. Thank I questions over further turn Dr. comments.

Athena Countouriotis

operator. you, Thank

my I think that name. has way operator was ever best an said the

that. Therapeutics. at for you that's and, course, for company our Obviously, very today thank Point for for in your Turning thank your of So, everybody dialed support you much interest

Q&A, And incredibly As I of the I'm during has many I always team said accomplished of of quarter. know all the you this close proud what I you. thanking by so to want every to close now in patients. everything for call. day call. and, may the as Thank you're us for Operator, more you importantly, you this doing that for company Thank a dial you.

Operator

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

You now Goodbye. disconnect. may

Turning Point Therapeutics (TPTX) 10 Aug 212021 Q2 Earnings call transcript