TPTX - Earnings call transcript Q1 2021 | Turning Point Therapeutics, Inc.

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Operator

Thank you all for standing by, and welcome to the Turning Point Therapeutics First Quarter 2021 Conference Call. All lines have been placed in listen-only mode until the question-and-answer session of today's conference. [Operator Instructions] I'll now hand the call over to your host, Jim Mazzola. Sir, you may begin.

Jim Mazzola

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

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

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

take our a Medical questions Officer. We location And will Chief Dr. in is call. following separate we'll by be joined Mohammad our for remarks. Hirmand, Mohammad today's prepared

your questions across bear please So both manage with us we sides. as

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

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

the over Now turn update me to Athena. let

Athena Countouriotis

Thank you, joining to afternoon today's on Jim, and us good call. everyone

to new Point approximately our just X Phase employees, X our years had clinical completed and ago, initial in has Turning just had offering ongoing one story, XX public one anyone assets For stage study.

Now two years later, XXX approximately we have employees.

have to next that our tyrosine the to as make Overall, four year clinical drivers we designation, to Xth this with of our inhibitors many asset and tremendous with repotrectinib continue of continued work candidates. and designations, advance has team plan our XXXX. lead growing Breakthrough important kinase stage our genetic cancer. so are we drug milestones for advancing our four of Therapy assets accomplish outlined proud study clinical target We five generation stage regulatory to the clinical including I'm Xth progress we start we

quarter The of the tumors. registration We in we positive treatment greater months long-term program the least a completion ROSX XXXX. with plan of followed believe upon oncology. XX will potent, ROSX. with greater higher Repotrectinib leader we of TRIDENT-X currently Therapy the crizotinib progress directed TRK is of on the advancing preclinical lead TKI We Phase I patient In provide are at FDA, be cell the engine, lung and feedback, which new we feedback responders generally cell the wildtype cancer first the with a of with portion past relates non-small our and goal have preclinical was studied are is FDA our higher plan having meeting the ongoing steps than discuss is solid start line of XX purpose which for a in ROSX all we against when Entrectinib the guidance to non-small manufacturing than with with further results positive Based This next for on the based discovery metastatic X cancer. we it to review potency pipeline central repotrectinib been recently population, X than TRIDENT-X The precision now have TKI-naive, companion as and it patient response. FDA Type patients and blinded the the to cohort lung with The addition, in advanced next development next-generation, positive. of TKI-naive, designation made the FDA being a for ROSX from growth. ROSX establishing towards ROSX patients NTRK Breakthrough with meeting granted on being positive independent B and in positive within guidance vision investing onset path on repotrectinib advanced completed top in our investments diagnostic meeting anticipate study. repotrectinib to potential to focus the was discuss supportive. during for TKI-naive to the of overall the positive meeting, clinical, be registrational

enrollment the TRIDENT-X to study. Turning in now

We being to X positive, enroll our the all data patients put in XX It X/X and continue study the Phase TRIDENT-X of alterations. remains harboring X NTRK half study target in our ALK, enrollment and cohorts Repotrectinib of Phase and ROSX the is solid lung anticipate an clinical reaching cell with TKI-naive, with non-small from the adult young second X pediatric CARE patient of Phase portion from tumors in across to or quarter. also update the year. studied cancer ROSX portions Phase of this patients goal advanced provide the in

this which trial, clinical continue five in one enroll patients studies. of ongoing our is We to

planning are the share this from We now half data this to study initial of in second year.

approved inhibition known is AKT AACR, and we GXXD, data At of the mutant suppress our to and signaling in in single preclinical the Trametinib, KRAS SRC KRAS to years. the preclinical of which as addition our study, relates In solid mechanisms months on both the cancer Xb/X CARE treatment planned to of Phase GXXD X/X planned models. Phase believed continues of development resistance. in third our IND within JAKX, oncogenic FAK, This towards study tumors derived mid TRIDENT-X which more fourth past And mutant of to based past and our XXXX. than pleased repotrectinib initiation to clearance is achieved and company-sponsored agent combination have R and and within repotrectinib cohort in the the are lung two our showed first and first patient of progress TRIDENT-X multi-arm, STATX study, make team combination in it combination repotrectinib's study we pancreatic effective V V was MEK-inhibitor with

safety, repotrectinib signals the with study the of any tolerability, As efficacy we announced in the KRAS-mutant previously combination pharmacokinetics first with cohort advanced and GXXD, solid of tumors. early patients will of in examine trametinib TRIDENT-X

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

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

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

recommended to Once safety we a cohorts. an the We last to patients Phase update across patient anticipate data responses Phase with of our in from clinical reminder, this second are update showed several patient portion generally objective heavily pre-treated identify The profile study selected, sharing a into X this continues we and quarter. preliminary well-tolerated year to directly our a Phase the Phase plan data multiple X population. the As track finding types tumor in with on goal year. half X in proceed additional X SHIELD-X dose the expansion dose dose of enroll

combination the a therapy. feedback, X and targeted finally Initiation FDA half the regarding anticipated for our study to SHIELD-X a of updates our Phase design. with modify EGFR initiation of the study including of of X/X XXX, in year multiple Phase an discussion the into registrational potential pending the this FDA portion second with have plans We study

compact mutations. our a being our positive. our study mutation pipeline patients X/X Next tumors to potency TKI in wildtype or with RET, studied RET ongoing multiple fusion, in TPX-XXXX, SWORD-X RET is XXX solid preclinical against is inhibitor RET determined in and Phase advanced currently be with

characterize dose. safety tolerated to generally reminder, patients pharmacokinetics, profile. encouraged well medical have profile for no data represents potential showing in clinical need continues the RET As enroll further to and before Phase opportunity selective the there been XXX XXX portion differentiation. recently efficacy with by the addition with approved X targeted a for of recommended unmet clinical and The and to population. continue was are TKI. therapies for SWORD-X XXX emerging a pretreated activity patients we to Phase data currently treated safety a We TPX-XXXX and schedules an prior presented believe in and this heavily early are We doses dose determining multiple finding evaluate who patient X of preliminary

protocol pretreated patients. We TKI include heavily multiple the expansion to have dose Phase X cohorts pretreated and less modified TKI-naive in both

data pipeline in in ALK study Next is our blood-brain inhibitor, the with patients potential cell cross preclinical the barrier. the XXXX Phase lung TPX-XXXX, for currently non-small demonstrating the of AACR, in presented our X we ALK-positive FORGE-X cancer. At to TKI-pretreated portion

sub-nanomolar resistant XXXX ALK Additionally, against in inhibitors mutations. has against potent potency to ALK we comparison more is and wildtype many observed clinically approved showed

patients pretreated ALK Lorbrena could currently current approved, inhibitors or While standard and great resistant profile given there and single efficacy this are setting, differentiate we in the care often mutations XXXX on is several and/or there it's many potential its known mutations. have potency initially but safety TKI potentially safety. we XXXX believe compound develop Well opportunity inhibits of off who limited to for an based believe against

discovery this to anticipated a reminder outline timeline is including candidates. us. focus to This plan research half Lastly, year second in our I to drug want growing we highlight team. for area And of our our a core the as new strategy

We forward year. our later to progress look making in more detail and sharing programs are this

to our turn let me Now financial results.

million non-cash in and current during financial by our to quarter, quarter driven expenses first that tables and operating as agreement Increased generated in XXX stage charge related million Non-GAAP totaled first the upfront million $XX.X for increased G&A from in expenses. $XX the to the and of million quarter excluding quarter the the You pipeline, in in first increase revenue well a primarily XXXX, investments for payment expenses, as were $XX.X increase stock-based $XX.X personnel. under earlier R&D China. XXXX. by one-time will million million, compensation Zai see we press Greater the we in to in expenses our release develop discovery $XX.X to licensing attributable our made Lab Operating an compared $XX.X of in expenses

five trials execute totaled Lab with initiate from Cash, used. and the during agreement equivalents the will $X.X discovery trials, XX partially cash make and March to Net expect billion. at used quarter investments efforts. revenue offsetting new cash totaled we securities continue as marketable across the $XX.X year in million cash clinical the additional We two clinical Zai expenses approximately increase generated our during we now

to in cancer enrollment our will the continue X close, of with rest ROSX Phase portions a operations the for XX current of patients of XXXX. our funds, beginning reaching quarter, this TRIDENT-X goals year of summarize target lung cell the the Phase milestone current our pools project and TKI-naive, non-small into positive, To with I anticipated X We cash key study.

mid on Moving year. to

second half, clinical the CARE the anticipate We in the and initiate from TRIDENT-X including SHIELD-X ongoing ongoing first providing Phase updates, expect study. to the three X/X we and from our TRIDENT-X of combination Pediatric data cohort And studies study. initial data

providing enrollment questions. Phase outlining on candidates. combination our feedback anticipate strategy, the we TRIDENT-X With and portion study, initiating are FDA we to development also study. Last, of update study from the anticipated now we pending to Additionally, our update, the plan an ready the SHIELD-X timeline research your including SHIELD-X initiating that X take

I the our close now line want you do, and far this open have great accomplished they we all Turning Before team growing questions. year. thanking Point by Operator, so for for to may

Operator

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

Your line is open. now

Charles Zhu

feedback the Thanks Zhu quarter, on Michael for the Schmidt. taking Charles FDA. from is the on the congrats questions for especially with This and

registration Regarding the if days, the actually [indiscernible] I'm for early cancer. meeting pre-Rozlytrek of which wrong potential think Thanks. FDA or very should me the forward And guidance given sounds lung so randomized Correct benchmark the efficacy this might to study? ROSX about a old we and great. from request types similar that is how and something a wondering, am perhaps XX-month updates? what be Rozlytrek's like potential scenarios recent I of follow-up path

Athena Countouriotis

sure. Yes,

of and Charles all, questions comment. First for the thanks the

back meeting we me We on positive. for specifically to and let data know independent line do that feedback so request believe with central top congratulations we've the And with yet. is based you, said, that feedback you data agree come you the a should the comment. we start review not unblinded That as blinded and thank discuss was that

Cohort with a the X of of patient population for minimum months since response. follow-up, last Specifically the one

is previous to guidance. your new about Now guidance. just This point

used meeting of our X to to of the end guidance standard at the for previous from was back minimum was months support Going approval approval. Rozlytrek end XXXX guidance which a Phase the follow-up guidance prior of to the our of FDA, as XX the

guidance. So again this is new

currently we're be will meeting are this again, of dependent that We with for year. a will be But next anticipating pleased QX data feedback. in

Charles Zhu

of us I related sense the of refining your the what copy kind this Plenary. the potential the MET Thanks. if at Makes a for number last it. helpful. I could going guess update expansion year amplification, you follow-up, TPX-XXXX alterations set Got diversity of provide and as some this year a and ranges you expectations to was of thoughts relative also later to and level in given population could help around cohorts wondering presented very was potentially of forward?

Athena Countouriotis

Sure.

So as remarks, I three second updates said we year. trial during give in half we clinical the will prepared have of the the

one the finding our dose portion. in the is That MET which from study, study to still alluding SHIELD-X You're program. remains

had data cohorts, the when at remember milligrams, multiple milligrams milligrams. we and XX you If presented in XXX session XX fall, last Plenary we

to lower to going QD cohorts titration BID additional doses, higher done dosing. also subsequently have or from We doses

during made that It anticipate is future tumor solid still your But gene be information this coming portion. of you will the is and said, the as refined with may yet number dose amplification MET patients We point. year to half advanced we in analysis population the cut expansion. for portion. this second done not a we estimate be number that something we're have that heterogeneous haven't that alterations. on finding MET a be And point We dose into dose the yet the this consider to copy not from will down the yet. move collecting. don't done in that dataset update we yet have for But an patients, So will it currently of the finding we what the we've

Operator

Paul Next of from the question is line Choi of Sachs. Goldman

Your line is now open.

Paul Choi

as focus a you're the anymore there, on types? follow-up off market any Have you're about communicate starting which tumor you the just Xb And on EGFR the how and how question. just combination which on thinking and kick provided to portion what on you gotten just more with MET Maybe SHIELD-X you'll Phase that? or of clarity

Athena Countouriotis

Yes, too. I'm happy

non-small likely. that So though, cell within lung The discussed have not we it discussed. have yet focusing we partner, be would EGFR combination cancer

that utilizing And through a an be investigational collaboration. agent either agent an so approved or could

to guidance haven't initiate in we trial but of half additional the that's So year. track that the the provided, remaining on second

Paul Choi

early of Okay, And maybe thanks that, FDA planned Athena. next TRIDENT-X, year. ahead for your then circling to back discussion and

the of to regard with Just sort telegraphing to completion and market.

Any Just meetings you that, specific the provide or thinking forum results that for from just that might front-line you cohorts. that? are medical how a about Thank very much.

Athena Countouriotis

with as Yes, pleased to ago Charles, I I mean, said so a moment FDA feedback. the we're

we on Of a next discuss our then with year meeting. for dataset It timing be the first. the would we're to And are further enrollment of addition looking first in then submit the feedback, to to complete this and quarter where course, for remaining the completion likely FDA practice FDA with the we the quarter, are forum. standard track future cohort to that this at results medical to

that not but be in yet obviously would have We though, determined XXXX. which forum

Operator

Matt line Next Biegler Oppenheimer. question of of from is the

now is line open. Your

Matt Biegler

It on a from seems is safety size consider Congrats approval? FDA But still wildcard want recent B of follow-up database Type to would the for duration any update. regulatory of you of that like the have your about the sense here. the gotten somewhat

Athena Countouriotis

with Historically, agency. used way of conversation Yes, follow-up XX that a that I precedent months that approval. us for then was the they follow-up gone has support interesting course, with ROSX/TRK. mean of if all, of duration first back, go the the And of the of was to in minimum you discussed

know, where already in unique two Therapy indication an sense this there Breakthrough it agents. a is the in that approved you Designation are As asset received

this the up. encouraged Type led to with with by that fact review the we're wants the with meeting, follow that and B agency so dataset to And us less

X, registration, So encouraging data with to the is never will discuss and is the but course Phase agency at what prior yet support dependent, of is central will from less say us, and blinded can't willing we've review than guidance. it up be the I that data that the follow looked dataset that independent

first patients with safety we not the kind have market safety history X, conversations from supporting Phase our my the I market history profile. course, taking the from the that's that would to of from safety X. perspective, taking of drugs benchmarks number only it. study way way from address From of have said, And Mohammad's to a built agency. of to a We we ongoing the with that sufficient Phase also general believe the TRIDENT-X of I database just So mean a we'll support but drugs

would would the be as the discussed patients be that review. how Now many needed numbers exact to during

Matt Biegler

That just one be be is discuss I quick guide for a tumors? with in up timelines. labeling you makes position might on a when and follow obviously like appreciate when sense. on on NTRK But ROSX. or Maybe any I to might expansion can label to the focus guidance, the opportunities you able

Athena Countouriotis

So, TRIDENT-X cohort as the track pretreated designation know, we've cohorts. that naive Track as as right we Fast study cohort, to now, two well within pre-treated received cohorts the you have the for already

are going TRK from that share our enrolling now study first patients. is ongoing to We data pediatric our

as also information So the there more not second that study. clinical doing it in study, of a turn about to half will the we data be we the update TRIDENT-X but on plan talked only relates the coming to year

specific I predict first I the when is think question, our will that into ROSX. TRK to yet. label with can't indication on go your based

clearly, discussion already the been Track. discussions data we've also Fast will with But Of in having course ongoing with dependent, received because and be agency that the we've agency.

Operator

Partners. of Zegbeh from question is Capital Next the of line Jallah ROTH

open. now is line Your

Zegbeh Jallah

update. nice very the for Thanks

the about couple Type Just the have Athena, meeting. B I is of Yes, a different think first questions.

I on update companion any wondering factored if that with had discussion into perhaps progress had was how [indiscernible] FDA, I that? with just timeline? the you mentioned And your diagnostics. then think your

Athena Countouriotis

difficulty Thank issues. I pronunciation name Yes. real Zegbeh do. you then I more have you. of And just, it's as have interesting your And always obviously probably with I

So few submitted we've with standard years. agency kind And was I and step companion only conversations you The the we exemption of cleared, previously feel had back for an and with relates first that CDRH device to disclosed go the last there. to that's for investigational a over development. it the we as had feedback diagnostic that

been assay for have trial using We we've clinical testing. the partner our and development prospective study companion our already identified diagnostic for in

So work the future. relates bit really discussion potential the to was The and been of as line companion labeling the need in doing in a are we've where we diagnostic. just it to today what quite support to do with agency we with

that's share now, ongoing but with so I agency of what specifically And the group. as we've would the and had again discussion CDRH

Zegbeh Jallah

then of to you're be on, just as for types. I'm specific if enriching TRIDENT-X the kind planning [indiscernible] for you And are study? wondering going dividing thinking about you're pursue tumor some label to And study,

Athena Countouriotis

with and this or study, so said is now GXXD X a that we're trial. we've right multi-arm advanced in TRIDENT where starting solid and multi-cohort The is tumors trametinib obviously

indications So KRAS-driven obviously there outside of GXXD. are other others be may

the initiating know, GXXC something already data that done now, we is disclosed happy But far haven't in very with just we've add You for so We're right the trial. with cleared would focus that future is AMGXXX, yet. so IND trametinib. the on and the in combination arm we whether

Zegbeh Jallah

CARE here, one the last study. pediatric the just then And Thanks. regarding

in policy? that base, is into just there know model that our patient we about Are to to nuances of any should it thinking take similar want terms account? Just identification,

Athena Countouriotis

But driven with I a heterogeneous for rare is ROSX the enrolled. driven unfortunately rare diagnosed or the remembering are that that that has year very would trial we out about had group even thing tumors fiber children have sarcomas one tumors, pediatric still many indication. NTRK this relatively So, say

the initial today. And say data And the so will in that's that But to share of we're that we're study. come second encouraged first half all from year. to ready the

Operator

the Next Securities. of from Silvan is Turkcan of question JMP line

open. Your line now is

Silvan Turkcan

think preclinical in a on and progress KRAS my KRAS and the your GXXD and that question for of the phase big some has about B How specific have maybe and taking could KRAS a GXXD And inhibitors, those you questions, that strategy we strategy all switch meeting. congrats I then going the inhibitors. specific Thank the picture Type partnering or maybe the triplet there we would a about always the can get? may MET be data would with with or, inhibitor, that what be or look how forward like? you

Athena Countouriotis

for of doublet, half where on it's just agents. say combine At MEK Silvan. regimen. IND you we've the inhibitor, that given little to be TKI on go the the this all a Thank questions, or to think and looking if stay going early cleared, the stay shown a medical data effect we forward conferences, over point the But I our future supports with of the say year the and in initiation I we'd first we're the trial, a the last that triple rationale to will multiple two consistently synergistic preclinical based at to a

as And we're and dataset this is where with to hopefully of strongest focusing again and doublets. MGXXD going add trial the go we're we going so start arms, where then you'll potentially we're to additionally see is that's the so more other where to first, depth that

Silvan Turkcan

second that of find XXX. or the out X and with year? to the MET communicate correctly you the And will update to half in Phase the in - There I we Will second you dose, if will quarter. be be respect understood do inhibition

Athena Countouriotis

about define to I that. are we evaluating that knowing mean the We've obviously this dose talked we want quarter.

on next And is an with where our So as well where The team pharmacokinetics, the we've incredibly is, call. are expansion move safety. outlined prepared quarterly our is into this recommended dose cohorts we're scenario in right Mohammad's evaluating likely as remarks. potentially focused. Phase X then ongoing as discuss we'll And dose area we

Operator

from is the line Arlinda of Lee of question Canaccord. Last

is now open. line Your

Arlinda Lee

TRIDENT-X One combination. a questions. the discussions. regulatory I on on have Congrats couple of the

combinations? constitutes cleared announced undertake? You first been the of what And Can an might combination. that talk you or about interesting additional combination you, these how just for you has IND for many

Athena Countouriotis

comments about the regulatory Arlinda the for of thank First all you, discussions.

to data the agency focused this that and TRIDENT-X MEK seen, trial relates it also design we're their the as shown well clearance. with without IND to two as Future point, trametinib. too much we've That's data initiating we've As support with saying again both showed went then agents inhibitors, trametinib AMGXXX. cohorts Verastem-XXXX to with as on the you've at

more will inhibitors. We is Cancer with GXXC say has one as entire I other compiled as and have Biology should publicly on this combinations. of said these translational at strengths the data go that the that where we've really of front, the we growing Siegfried group been looking tremendously front, well also his science to dictate in

going point, then And would to and I at we I'll this all adding extent, additional are we some determine towards Arlinda preclinical just next go say say that's dosing absolutely so trial based start the moving probably we data. patient cohorts. how on And until to where will the

Jim Mazzola

Thanks, Any operator. other questions?

Operator

questions. further No

Athena Countouriotis

well. a and all, Okay. whole. today hope everybody Therapeutics again Well, thank I as you to Thank families Turning and much. call. operator, may and of Point you team dialed first the in you who close for very our interest your stay for you of And for your now support continue

Operator

today's all for concludes participating. And you Thank that conference.

disconnect. now may You

Turning Point Therapeutics (TPTX) 8 May 212021 Q1 Earnings call transcript