TCRR - Earnings call transcript Q1 2019

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon, ladies and gentlemen, and welcome to the TCR2' First Quarter 2019 Earnings Conference Call.

As a reminder, this conference call maybe recorded. I would now like to introduce your host for today’s conference call Carl Mauch, Director of Investor Relations and Corporate Communications. Sir, you may begin.

Carl Mauch

Thank you, operator. you us thank today’s and afternoon for on joining call. Good the a close results, announcing in our today, market press at which section www.tcrX.com. website we available financial After XXXX issued release of quarter our is Investor first call, me Financial Menzel, Chief our have joining Hofmeister, Officer. Quintás, Alfonso our Officer; Today Officer; we Somaiya, our and Scientific Executive Robert Ian Garry the on our Officer; Chief Chief Medical Chief

forward-looking that our our begin like I including this potential call the discussion, include development and everyone we Before to of will would statements candidates regarding statements remind therapeutic pipeline.

to today. subject risks filings beyond SEC and Forward-looking to call statements information call which the obligation the to described no or of provided new or uncertainties revise uncertainties, and are the or a as With our future update are control, risks We turn over including numerous this developments. close and XX-Q our many now information results filed of result Garry. I'll on that, in our market undertake after

Garry Menzel

Carl, was good the that quarterly cancer into us provide clinic effective to crossed tumors. with ever We solid quest of first on our in hematologic and everyone. I today continued threshold and from by of afternoon appreciate treatment our first joining call quarter patients XXXX TC-XXX. delighted first you to our options new a for the suffering and cancers range we am wide report marked Most progress conference you, the therapy important, Thank

of cells the T The our In factor cell T natural believe of can that expression. T proprietary have properties differentiating could and the both corporate of cytokine XXXX, complex we the shortcomings novel Today, consistent we engineering include: entire responses TC-XXX. we preclinical is durable TRuC one, cell platform, pioneering are you that solid in the TCR key translate These IND which harness independent T events studies, clearance cell CAR-T receptor and longer know, received HLA can signaling with development these may As our believe therapies. our and FDA into address adverse the a our of tumor cancer. potentially been we activity, achievements that antitumor greater with less in plan. fewer more timelines key persistence release for observed patients program for we the with already have

putting We clinical two cancer, that Catapult. the file second with have took on year. TC-XXX, to FDA trial we lung and meeting we our with pre-IND already first occupancy Cell and mesothelioma. screening had and cholangiocarcinoma IND this mesothelin-positive for non-small us Gene cancer, our program, begun Therapy sites successful an patients the for suite malignant track Two, cell hematology the manufacturing opened half therapy of at ovarian Three, in a of

partnership cell call therapy boost T preclinical and T TRuC us published data claims in exercise This Alfonso Medical express team. meet our in will to were placing however, all Chief ever public in that is publication. of us over initial at Officer. And our turn we our to strong that I matter TCR detail while We future Quintás, clinical facilities to effective to beyond to TCRX, support our Catapult relationship manufacturing to Most option, significantly providing the capacity financial to Four, needs development to clinical expect advanced including current CDMO our access the we to continue this TCRX and underwriters from completed expert treatments TC-XXX. enable trial the Nature peer-reviewed approach. quest composition cells patent offering anti-mesothelin advantages bring the first into more Five, outline leading cancer progress patients. XXXX. covering important in To our our regard, our journal, our proteins showing our allotment fusion academic the support successfully marked program we a on over Communications six, a including of of first position issued the full the

Alfonso Quintás

Thanks, Garry.

been screening received TC-XXX our drug XXXX clinical FDA granted Phase IND two us. orphan also clearance the And of In important quality quarter the designation FDA very against treatment our sites of X/X we mesothelioma. in the January, has from have high TC-XXX. Currently, for trial was by for for of drug lead February, first The for we mesothelin. for actively patients TC-XXX,

receive this escalating of patients the patient cell XX focus At cancer and four dose TC-XXX enrolled cholangiocarcinoma either dose. chemotherapy. TC-XXX period. mesothelioma enroll day period the infusion following mesothelin. will X observation then Upon determine study safety the of receive the TC-XXX. by safety or Phase X a will each dose cancer to is a patients at over with lung with the XX-day subsequent level, three following study in of escalation ovarian standard The will study will X observation doses Dose follow given without non-small evaluate our any for Our a patient will first objective Phase portion lymphodepletion same recommended expressing The there cohort safety lymphodepleting design. three be will three Phase patient key last the

key translational TRuC-T multiple and trafficking, assess Additionally, TC-XXX such to studies will expansion, of patients' cells for we attributes be as persistence. conducting tissues

two XXXX. us of trial allow of single with the we providing confirm XX the we for trial will to characteristics Phase Our XX evaluate lung patients patients our will Eight will cohorts Each patients We the fourth and will plan of will Phase modalities. recommended at the four in synergy to TC-XXX in TC-XXX cell a cancer inpatients update who portion the TC-XXX XX to observe in potential These distinct based which in an enroll as agent the patients. approximately anticipate of of therapeutic receive quarter with will studies. patients receive X histology. cohort, the us X/X dose a Phase non-small TC-XXX on antibody. TRuCs, tumor exception will X receive cohort which blocking include clinical enable XX pre-clinical translational will enroll the our PD-X combination of studies In unique

earlier stage Now touch targeting pre-IND programs. quarter the our XXXX. FDA candidate positive the cell briefly with upon for to of held TC-XXX hematological Company first meeting a CDXX malignancies lead The TRuC-T are in

positive continues focus toxicity on track Our enabling limitations candidate clinical studies. cell submit TC-XXX lymphoblastic T-cells either of IND being areas, remain we indications lymphomas, to are three conducting or have TC-XXX yet all are or for which not specific With We the XXXX indolent for TC-XXX. MUCXX phase cell approved IND efficacy. be and TRuC-T have for in in B adult aggressive which CAR to acute of terms of an second our half and on tumors targeting leukemia,

of its expression tumors to are expression solid normal We in many target a MUCXX attracted in and high because tissues. low as

half file update We is TC-XXX over on first are currently pulling IND in our and our financial the to an results. XXXX. now together for for call turn goal preclinical the the I'll quarterly of package an Ian to

Ian Somaiya

In you quarter financial first Alfonso. today's our we press reported release, Thank XXXX results.

advance capitalized strong report our in position Following well enhance our offering to initial are a and I'm that financial further platform. pipeline and our we're in public to February, happy

in compared December million the to was period million public the March used had due in the approximately of XXXX. $XXX for of $X and quarter approximately our $XX primarily This As $XXX XX, XXXX from $XX proceeds cash was Net investments net cash, as TCRX in year. XX, cash equivalents million increase compared for first offering. operations million last to initial million same to

to the $X for company. quarter for increase compared of to period for same trial headcount. TC-XXX For were in personnel The the expenses to start and the year. same Phase $X million last the of and million primarily public year. activities approximately in in the primarily first related quarter to X/X million $X General and G&A an of increase increase the of was expenses period XXXX to R&D $X costs last administrative clinical were costs The was operating expenses a increase compared due first million due

the year, quarter. R&D million the compared for the our expenses of XXXX to primarily period first by increased million loss $XX quarter net last in driven was $X for same Our

to Now million equivalents. healthy $XXX cash that turning in we you $XXX XXXX With open full-year with expenditure end guidance, can from financial to range to net million cash aim $XX operator, our to lines Q&A? the million a please $XX XXXX cash and million expect to and for

Operator

question Biren from Thank from Instructions] Amin first Our comes Please go ahead. you sir. [Operator Jefferies.

Biren Amin

assay? allowed you deemed changed risk. IHC confidence Can in non-significant it amended just protocol how Guys. Assay risks for back to Hi Yes. Maybe, the significant with me the noticed I just protocol then start to the Thanks taking let where through program. be be better the my the the to deemed have CDRH in but February CDRH questions. you that, a that TC-XXX walk the they

Alfonso Quintás

Hi Yes. thanks for this question. is Biren, the Alfonso,

FDA to ovarian cancer incubator in cancer, that that the that that or design two Upon submit back two, we sure have language letter mutations, So, February, study. study, wanted they enrolled approved PARP they TKI discussion in them. really regard sure they for We specific for the patient inhibitor make the sure of with that more being sure the correct. cell patients being to patients and wanted developed the to therapy. you to number that the the received non-small they FDA in all to each describing very study. we or prior And wanted is osimertinib are patients, populations. they make IDA is And received had one those TXXXM FDA, make enrolled each clinical they received with BRCAX of requesting with of specifically, prior they the received failed make One wanted they what had for to in a in had included we EGFR should patients that that therapy protocol, one that lung BRCAX considered had to and language had specified wanted indications explicit our specific an mutation request and from with an on the if to agents mutation, subsequently of prior had

to protocol, to the to and application. an two FDA FDA and the IDA communicated those upon main were the resubmitted not changes was that So submit amended, us we the which added which need then

Garry Menzel

And Biren, it's Gary.

these literally sentences our in Just heard three just two resubmission. required to further and as to emphasize, minor changes you were

Biren Amin

levels, but the evaluate that – changes then to will it. investigating you regimens? know dose And aspect, Got across are regimens? also allow different Phase potential I four Is dose finding different lymphodepletion X you've that just got you dose on finding

Garry Menzel

such way No, is protocols for or that stand not uplift We're combinations doses of now contemplating the the dose regimen different we exploring now the XXX evaluate agents. escalating different will right those TC-XXX. right of

Biren Amin

get we end we some data. many at guess, follow-up publish or to the at how And the point? much could maybe Great. that how then What you're I present will of expecting just year expect, patients,

Garry Menzel

we point the worth without be. won't delays. enrollment of to specific that What on this Well, – unexpected think I we and is the screening, numbers. idea what any will are reminding can progressing say is well manufacturing pace What the study an give patient well be commenting of of design enrollment the is within any

appreciate any we time meaning same we will TC-XXX for will safety dose that don't And so cohort If lymphodepleting but the dose signals. dose TC-XXX, then find we safety a limiting we again, open patients lymphodepletion. we without treat any this XX will patient Then signals, have different within dose first each we looking of will of of chemotherapy. we following receive wait one toxicity, four levels three days don't

plus will the what And we the following looking safety will happens then signals. so to patients days if no will will dose is next simultaneously. dose exercise. then And wait level escalate two first signals, patient three And enroll of we And rules then safety the another after for three repeat design. have the at a same XX we

portion. are mechanics be of X in And study to the so those going Phase the

patients Just study. how we're to the in to give you enroll an going idea of

Biren Amin

Great. Thank you.

Garry Menzel

So at be second what part I the you Biren, your think, the year? should question was end expecting of the of

Biren Amin

Correct.

Garry Menzel

types different collecting we the certainly think are and this. Alfonso or data in collecting perform on that if particular you that described. of Robert we just data So can of We're Alfonso that as the studies expand three case,

of safety collecting foremost, and First course data. we're

Our that hope doses. Ultimately, would that early. course that require but we see higher see of we want be may efficacy. possible we we early, would It's

correlated. The of is what that might collecting you other call data bucket we're

looking here try to perform our they and same the whether that not in TRuC-T cells So where perform humans are way in animals. or determine we is

TRuC-T phenotype, that collecting exhaustion, cell we're certainly early cell so and we're So cytokine expansion immuno the looking because cell We're activation, at functionality, data it's looking forth. at and at of TRuC-T that's indicator important involves looking an at cell looking fent. tumor so memory, persistence TRuC-T we're TRuC-T infiltration, production, so

proxy correlates as So act will going efficacy forward. a data of for the this

provide when sure point release. with to form might presentation what press a it we year at line you see are not or in not may And in a up, an seeing. we’ll the of during a data the described as some any it So of form conference those we're fit be of as it update the we because be

Biren Amin

Great, thank you.

Operator

Thank you.

from Our next question Jonathan Leerink. go from Please SVB Chang comes ahead.

Jonathan Chang

questions. Hi Thanks guys. taking for my

First can level cell question, evaluated thinking TC-XXX needed study? activity talk in study? dose the you how are achieve about doses in to about And the this being the you cell

Garry Menzel

Yes, thank you.

just my solid the not experience use. hematology of can in So the the as we going on in as selection informed you very prior What been importantly, don't we’re well doses comment tumors on both has also to with is specifically dose CAR-Ts, we that but tell by TCR-Ts.

dose throttled the TCR-Ts explored in and the preclinical doses as of is well CAR-Ts in gamut therapies by used models. cover designed doses our to solid animal we've models that schema also cell tumors and escalation in wide So informed cell as

Jonathan Chang

it. Got

Cell are currently over what with manufacturing see talk the how and Gene do Catapult, you your about you Second your Therapy and evolving question, with capabilities that collaboration time? can

Ian Somaiya

Sure. demands CDMOs, for meet the for question. Jonathan, able take the with we're our trial TC-XXX. to I'll Through X/X it’s Phase Ian, collaborations that

have allow aspect us As of a potential option to Catapult, Catapult, a which meet study. treat with on we've which and capacity will you'll taken clean increase of to of upwards patients where a our room, patients. we effect us note, our an second And needs occupancy there's in collaboration allows unique XXX the X Phase treat to for

Jonathan Chang

question, in thoughts Thanks. just data are overall AACR. updated I'm at Thanks. what for the to recent your mesothelin curious as platform? a it. And Got thoughts last your your one get target post field on

Ian Somaiya

specific commenting Yes, data and without on other groups. from a

I AACR. think the at the data we've seen

CAR-T there's hand of is therapeutic the solid way a us of of even that validates robust a But modalities mesothelin, data validates achieving having targeted it field work further cell further good mesothelin efficacy a in patients validates one in now therapies validates telling field. and but the I number On significant out T think adoptive solid clinical malignancies, also mesothelin there. with this of is It tumors. with cell body the

tracking out other that our think from inform come very studies. groups I that those it's have overall, So positive own will data and continue we’ll data

Garry Menzel

seen And some their CAR-Ts maybe results. the did produced combination best the presentation, the thing the add, other arm I could of lack AACR one wherein also the own persistency it the and highlight of on CAR-Ts one we’ve of was that the and of with case limitations

Jonathan Chang

Got it. Thank you.

Operator

go question you. comes Capital next Do from from Thank Instructions] Please Kim Markets. Our BMO ahead. [Operator

Do Kim

questions. Good afternoon. my taking Thanks for

lung In instead follow of you instead just data of suggest for does to lung cohorts all on I cancer, CAR-T your the targeted that Phase Just cancer? up adding that potentially that AACR should therapy. anti-PD-X to mesothelin be X mind, mean,

Garry Menzel

if replicated other that efficacy cells. say because I are cell IV administration again, clinical vivo no. right they our preclinical their the to that think with Kettering see tweet achieve Sloan two that, do in think the CAR-Ts. superior which to IV of science. that's when T that yes hand what only administration especially performing pursue the to models we which IV, locally think on we I TRuC-T In blocking in should thing what themselves we identical IV have administration to is and will one necessarily. the that administration they seen T done, not with is and we local CAR-Ts. in tweet difference. the In published the in And of an cell. far fundamentally efficacy, other I PD-X following We malignancies to the this they addition follow No, trial. I render agents to local have Well, or therapies adoptive run when their science, of on And is elected is in combination words, and we amenable of And the the that models, Memorial the after words, why, therapies haven't the other

the study. of consideration see an to we're design one investigator is initiated The likely TC-XXX in can study, the what you of administration as is going give TC-XXX but that to we're context do of study our a of the ideas So, considering, IV. going are local in most perhaps on of we and separate

For Phase on the this only. X going to of IV X, study, Phase purpose administration we're focus

Do Kim

that Could your the how And the in more tumor. toward CAR-Ts. full see. the quickly in tumor also TRuC-T lot I the talk migrate preclinical a cells homing studies about plays that TCR shown you've you toward than

Robert Hofmeister

is we of compared faster Yes, This indeed, have the faster Hello. and that Robert. TRuC-T cell attribute preclinical T signaling cells full we to the shown models to receptor. in CARs accumulates our migrates broad and Yes. And there. that

So are unit we a not entire signaling complex. example, of sub become cells, entire on utilize attributes able migration the rely the unit, for the say into that to signaling but we one other facilitates to tumors. like number with the do of which CXCRX upregulation sub on only the complex TRuC-T And

Do Kim

Great.

Garry Menzel

me PD-X. the combination question And with on the then let of out

have synergies good of an remind Phase course, PD-X in the a antibody. with may TC-XXX it's that expanding combine we the suggest see other us if study, that we paradigm and the X that will specifically arm, where to blocking study. of arms two lung data arm non-small the cell of think we I portion see to And you the will cancer

Do Kim

there part by TC-XXX? was And been do or with meeting Right. early program that to Thank your potentially new think you you've In concerns you. lymphodepletion you'll on process skip to the since FDA faster compared be XXX, that TC-XXX. able question for through the conduct a dosing? the any and stage And of your interactions pre-IND last questions without

Garry Menzel

exactly correct. you're Yes,

conversation will it, data with we FDA the is design clinical without focus to in basically and secondly, what the dose the that trial. on just for in the the your that of see escalation is the which the So aspect phase, a elimination package. the And of explicitly of two the clearly touch IND revolves specific upon on the describe TC-XXX, the conversation one lean we you definition which for agency around And basically want the DLTs, on very aspects; clinical question, something ask patient requirement. the

see much to study TC-XXX you will So that us progressing the program. compared faster to

Do Kim

Great. for question. Thank you my taking

Operator

Thank and see session time. you. gentlemen, I for ladies concludes the no questions this today's queue you, This further in call. Thank Q&A our at and attendance.

disconnect. You may all

Tcr2 Therapeutics (TCRR) 13 May 192019 Q1 Earnings call transcript