GTHX - Earnings call transcript Q3 2018

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Operator

Good day, ladies and gentlemen, and welcome to the G1 Therapeutics Third Quarter 2018 Financial Results Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Jeff Macdonald.

You may begin.

Jeff Macdonald

Thank you, operator. welcome and GX Corporate and XXXX Third everyone, Results Financial Update. afternoon, to Therapeutics the Quarter Good

Joining me R&D; are President, Malik, Chief Chief Mark Officer Corporate Velleca, Chief Officer Financial Senior Executive Development. and Vice Senior President, and and Phillips, Medical Buck Vice Officer; Raj

expected results. SEC, cause I'll website will Such company. that from and Before on begin, the Please materially could statements factors filings uncertainties refer the Mark. judgment of corporate with which today call SEC represent involve now to turn the differ for like our statements from risks risk affect based that you our that to management's information the concerning results we are forward-looking call remind on available may and could would to or today's I to over include actual current expectations. as

Mark Velleca

ESMO, first for in and red thanks across afternoon, the line clinical we'll focused financials, robust severe top provide Good transfusions. small presented neutropenia II blood duration trials our Jeff. call, that third you, lerociclib of readouts and pipeline: we I'll lung analysis review we will trilaciclib product update announced our Raj Phase data and GXTXX. new trial benefits demonstrating and with of a open Buck cell questions. Last the trilaciclib, then programs, trilaciclib. call Starting positive everyone, March, on for XXXX, of showing at quarter reduced month discuss In line cell myelopreservation In that cancer. On will on Thank data joining company today's all in candidates the upcoming and status trilaciclib. us our brief today. of three execution for

subsets lymphocytes. data arm. the the on in placebo number presented We trilaciclib lymphocyte of first on we addition, improvements compared arm the across In to a saw effect trilaciclib's clinical

support our with when T-cell system therefore ratio activated improve may peripheral hypothesis improved regiments. data immune CDX positive overall checkpoint regulatory T-cell that the function, counts combined in survival positive blood. chemotherapy CDX increased to trilaciclib These trilaciclib and and Importantly, activated increase

in are We currently trial line trilaciclib/chemotherapy/Tecentriq small our lung assessing in cancer. this cell first

The data and trials now myelopreservation survival data end This be will PFS year, by not by Raj will our cancer. XXXX. report in rate other of to We II Ib turn lerociclib, response expect CDKX/X trilaciclib plus oral program lerociclib lerociclib we enrolling. clinical IIa from more two data to portion next overall is two and and I'll from in trilaciclib/chemotherapy/Tecentriq Enrollment year-end. non-small in HERX-negative our on programs will the preliminary is the reporting cell matured the trials ER-positive, detail While lung addition the to randomized an our plus data momentarily. from of of escalation inhibitor. portion track, Faslodex report clinical review Phase our both trial cancer, trial dose we trial Phase in Phase currently year. until Tagrisso have breast

we of estrogen escalation degrader, or Phase our GXTXX, are the portion our continuing oral of selective trial SERD. I/II Finally, receptor dose clinical

which data of first report enrollment XXXX. We of Phase escalation in half half complete trial, breast GXTXX I to to HERX-negative evaluating Phase We the the XXXX. the monotherapy in dose of ER-positive expect preliminary plan cancer the of second I is portion as in

trial Raj? data will the our and Raj regimen. readouts. II lerociclib GXTXX as arms: recommended upcoming a Phase a of dose, provide second more GXTXX will two consist identification monotherapy of trilaciclib the detail Assuming part of now on combination

Rajesh Malik

afternoon, Thanks, Mark, and everyone. good

cell we As first already robust data in myelopreservation reported chemotherapy small lung Mark from noted, have trilaciclib trial our cancer. line

randomized sets, end I'd Phase all minutes II to on few of are readouts context provide additional trilaciclib like to data before data three from some a We the trials. take those year. the of have which

patient Phase the trial cancer, patients and enrolled trilaciclib similar our line first patients. with backbone of the inhibitor, small The in chemotherapy same and is chemotherapy II etoposide XXX carboplatin. and cell chemotherapy Tecentriq, lung received trial in Our population of combination checkpoint to trilaciclib

that two This lung cancer. the combination the patient immune Tecentriq Data in in myelotoxicity increase to for assessing Overall not system cell Given in trial, chemotherapy. whether to of the chemotherapy/Tecentriq to of etoposide and and small the first will Tecentriq, will by trilaciclib question benefits a chemotherapy was trial when similar myelopreservation trilaciclib/chemotherapy answer populations IMpowerXXX trials small from the can impact activity the population the the with our in trial also trial data designed trials same function. line was robust from preserving carboplatin this enhancing Roche/Genentech's backbone trial, similar cell and line preliminary antitumor release and we of is rate survival we Therefore, in expect response data. does reported press data these results report regimen a to preliminary that observe and expect survival provide lung tumor mature also results added progression-free chemotherapy/Tecentriq data a and myelopreservation issuing year. will later this used the Myelopreservation we which but line our patient be benefits top to trilaciclib year, we anticipate set cancer. be not when first provide in second show from trilaciclib,

second-/third-line efficacy. In cancer disease immune until improved and were small may receive chemotherapy, cancer triple preserving progression, additional metastatic where to patients cycles cell also is and settings, breast in leading these Our given system function negative to assess HSPC trials antitumor of to chemotherapy enable designed lung potentially myelopreservation.

cancer Our most participants, provide comprised patients myelotoxic has been data second-/third-line one background will whose bone marrow which lines a previous of is chemotherapy. topotecan, already of trial, on of myelopreservation chemotherapy chemotherapies. the who received regimen cell in effects by Topotecan enrolled XXX lung small

to a trial, top on So in blood trial release. the neutrophils, provide plan on data data to lymphocytes, and anticipate we this data via addition will cells red Similar we to myelopreservation line provide platelets. trilaciclib/chemotherapy/Tecentriq press

and data. survival rate tumor myelopreservation, progression-free preliminary report will We response

three will report two trial data cancer is triple survival we and The will trilaciclib alone and overall and plus X XX-day across patients days on enrolled arms: the carboplatin breast administered in chemo chemotherapy expect mature gemcitabine and immature, used this be schedules cycle. The regimen in when the XXX X date available. chemo. We of trial dosing negative

trial We of Symposium to at are day testing to of see administering be on if of San Data the the and will compared has day effects in will data, pool accessible our data on on Antonio from Data so the December trilaciclib our randomized day the only Breast just administration analysis trilaciclib three presented abstract. will different arms of prior website. available the chemotherapy this prior final Cancer poster, to will chemotherapy. which from X. filed the in the be We submitted published abstract to be be

will myelopreservation, tumor rate We and present progression-free response preliminary data. survival

and will when will immature, mature available. We expect data the overall report we survival date be

U.S. with European across meetings therapy in early request XXX XXXX for will and who data lines We chemotherapy received and different authorities regimens. of trilaciclib to discuss than indications, regulatory participants more

financials. over data of we for the Buck? will part I on discussion of third As quarter potential the the these the turn a meetings, now trilaciclib. will Buck and for to call feedback totality path registration request of

Barclay Phillips

Thank you, Raj.

in you available $XX.X for Operating were press Our expense $XX.X and third million release. I'd were in compared to for the take in to of compared through earnings of for XXXX expenses for of expenses. a financial our combination quarter enables in fees activities We through In for net we third quarter, in $X.X expenses of to to operating driven driven of the of the loss and growth largely quarter the in GAAP third increased is quarter reported costs for XXXX the early of million quarter advance million corporate which The programs. administrative be that mid-September. the increase prior the personnel third to trilaciclib. to period. costs, us contained financial quarter candidates professional strong for by The program for $XX.X our our Research and was third increase the a release, stock-based for position this like net million and costs on the a XXXX website. pre-commercialization other $XX.X compared the clinical General can million in in of million walk investment of expenses million by that the compensation ATM third highlights cash found expenses an proceeds compared XXXX. compared in quarter an million were quarter million results opportunity the third and to the third raised $X.X quarter Those million noncash to $X year provide XXXX our development XXXX. issuances million company of $X.X $XX.X year prior in XXXX secondary total for a $XX.X the increase QX $XXX.X personnel quarter expenses including for XXXX. of to to expense clinical begin increase offering of with of support period. X-product third was financings a and

and XXXX, cash As on sheet. of in the September $XXX.X cash equivalents had million balance XX, we

prior million balance will our This to to million. to on range that in the on guidance, $XX guidance million of $XXX expect guidance in end to sheet. With the million million. $XX narrow with our year largely cash the year $XX $XX With complete, used operations to compares XXXX $XXX updated I a cash of million we to in

influenced beyond. heavily the between XXXX will commercial into and The three of ahead by Looking be trials the activities those trilaciclib clinical, now will results trials of and out our XXXX, end regulatory the and year. reading in expenses dictate

which We our now guidance expect XXXX, to call to will provide year-end to earnings in the me define I'll cash February. in over Mark. call operating early allow turn plan that XXXX on

Mark Velleca

Buck. Thanks,

of trials. and to these our regulators four discuss will to of summary, II dialogue randomized with plan the we totality the Phase European trilaciclib in Q&A, We early from As the data. U.S. by we a XXXX before clinical end quick year update to on go continue

in questions. in on cell cancer provide in in to data and we update ER-positive, second GXTXX the we HERX-negative for regulatory both an data are second half our in Phase strategy the report will trials XXXX. from combination Tagrisso quarter I in Faslodex breast lerociclib programs with of those please trial HERX-negative That our of our of enrolling report meetings. our will cancer open concludes track, expect We following ER-positive, the in Operator, XXXX. XXXX, cancer, Enrollment on line remarks. breast non-small We're prepared lung and and in

Operator

from first [Operator comes Anupam question Rama JPMorgan. Instructions] of Our

Tessa Romero

Tessa This evening. on for Romero this is Anupam

this if data in package San early of of from presentation December to XXXX at with been the to registration trilaciclib expect your from sense of date to us ahead on any discussions two respect aligned remind generally meetings can regulators feedback X? request us you guidance you see give point abstract can what topic data the a And expect specific secondly, as the registration Can you Antonio First, how their in it collected FDA you're discuss And then relates breast seeking with have the an path agencies to like for agent trilaciclib? we forward? to within the to-date. to EMEA, and in the

Mark Velleca

going take I'm Raj? Tessa. those. Raj to Thanks, let

Rajesh Malik

Yes.

hi. three to Tessa going was in going pooled data have by is abstract The be be data arms. we other arms. at it In presenting So published Obviously, for abstract, all And deadline to soon, the the TNBC for we didn't data in be that along. we this that breaking itself, data. the consist came on will will will not out of the analysis words, be -- the meeting available the submission reason is

regulatory totality And to in three these out. from going of meetings consist what they run the we we to, XXXX the depend think, like the data in I are topics, have now. we their going to another it's generally data could look of of trial, example, and of or of what terms the reading review trials on development in need right for that are terms endpoints the see if So obviously, just

of now. that In terms are of ongoing matter alignment right across comment on really I These the discussions. can't two agencies,

Operator

Shibutani question comes & from Company. next of Chris Cowen Our [ph]

Unidentified Analyst

approaching for next broad your with complex chemo set. regulators across data the myelopreservation regimens, some you're the various of improvement for sets with to across thinking you're pretty going So idea how various multiple approaching strategy the and endpoints you give multiple regimens indications, three thresholds that? year be about and regulators us Can data

Mark Velleca

take one. Sure. Raj Again, let that going I'm to

Rajesh Malik

not And the anticipate the Based Yes, myelotoxicity. CJ. see any on in drives because the as do like we Again, we the we that same Tecentriq line have to back the that on first our chemo the IMpowerXXX data, discussions. data, data backbone first before, March. has we think all impact chemo I reported Tecentriq data out mentioned of

to data as data -- we view the back compared So March. in the closest we got really to that being would set

the patients therapy. settings as In different the in as two terms different are in in are other of There trial. both TNBC cell trials, the small of and lines there well previously treated

we'll We discussions will be endpoints, of types let regulatory we have have looking with the at, to and data obviously, drive authorities. similar

Unidentified Analyst

the there to particular hoping any or the topotecan gemcitabine/carbo Is benchmark see you're for regimens?

Rajesh Malik

Yes.

you than be and we'll And myelotoxic of testing, effects etoposide actually, will. gives the gem/carbo thrombocytopenia If also obviously thrombocytopenia. we're if you the neutropenia significant where all also as most regimens it's at and you and topotecan, of look see more on be carbo. at And interested looking the regimen anemia the fourth and rates very in the that anemia will that you platelets lineage,

and these breadth -- myelopreservation think to randomized give other all is us settings of different I the across say was back get these we just effects. to the are point trials just why trials. to the design to really And So

have really we an So sense of a effect. in-trial the comparison give us myelopreservation to

Operator

Our question comes of David Wedbush from Nierengarten Securities. next

David Nierengarten

but could And used this or patients? point to number is often that you treating I achieved progression, and line studies cycles studies standard is front for metastatic from you on I cell was could help with us chemo, six other if -- the background you negative or cancer out the triple the of small with breast typical to given cycles the population? contrast are wondering the in know there typical chemo of in settings

Rajesh Malik

Raj again. here, David,

sorry. for say patient generally to line are the So yes, cell opposed would is small publications look particularly median backbone, at without patients these four reported. of in cycles if the been that I you about on you're But has in -- the TNBC of first settings that, treated gem/carbo yes, what as and progression right

David Nierengarten

studies, I it? question. or number in also six maximum -- And that's eight that cycles mean, the or the is then guess, is I without range limitation, next prior mean, typical the what I what's in or it

Rajesh Malik

you David, me said upper sorry, limit, what will? asking you I'm if the you're to provide

David Nierengarten

unacceptable upper is was cycle there's cycles range what Yes. that numbers, four That progression usually to toxicity or around eight it? the six limit, usually of a or

Rajesh Malik

toxicity. either it's vary, think progression I because think, reason or disease a the that's I treatment reasonable Yes, going to assumption but stopping unacceptable is for

So reasonable assumption. I think that's a

David Nierengarten

toxicity. toxicity follow-up is that then And last Is you is in it of myelosuppression Do chemo? the side one on of from causes unacceptable that patients? know most breakdown what effects cessation those Or it other chemo?

Rajesh Malik

Yes. No.

would for say and in common be next be disease think I will the reason most that, the there beyond discontinuation I common would tox. setting, category But the most drug would that hem be common toxicity progression.

variety platelets typical would of So versus a the neutrophils combination. be

Operator

Company. from Chad Our of next Needham comes & question Messer

Chad Messer

it's and So to going excited. year-end, be of bit must be data enrollment a a through guys you

through make a whether it easier open couple next think effect. guys to on harder I chemo, see patients and/or trying of there any the we you that instructive already going myelopreservation a whether is anything from whether that's to expect? Wondering data for what thoughts might label have Just or thinking to about these seen indicate that keep have studies to

Rajesh Malik

would expect effect some see myelopreservation. We to on

patients have Of therapy prior beaten as received. course, you bone different the marrow lines be say, by the that in delta coming more up could is of potentially the because

in what we are will So but myelopreservation the anxious, I know. effect. would we just as to well first like, line, we saw it to we see Whether as think same be you that anxious see are as effect some expect will looks

Chad Messer

up because opposite that mean, trilaciclib, if on is possible marrow is not also so patients that these very they're bone was results. might, thinking the they guess, the poor I I I had beat just

delta I is way, can So think what the go I'm... either I guess

Rajesh Malik

absolutely could go either It way.

correct. absolutely, You're

Mark Velleca

and, the Right. TNBC, X, chemo. have some of patient And lines of in It's two on it's I both those and in -- just want received to who that second-/third-line prior TNBC case who remind you each mixed. patients population studies three are

a it's mixed bag. So

Rajesh Malik

is. It

Chad Messer

higher then And guys to T-cells guys known? CDX data ratios CDX new if levels you shown presented important? how to are was be activated of regulatory knew ESMO. or And I if what saw, you on that the such of sort compares have at just wondering quantities been cell what

Rajesh Malik

Yes.

there so data necessarily it's think emerging maybe I I an couldn't But for -- And sometimes think, know tell that's you definitely that. the I is hard -- field. of I I don't mean other ratios -- that or if XX:X I heard any less.

the some in that checkpoint think from could coming the all data world. piece an be also favorably associated that This data CDX I like out response. that's other with is cells is increase

we'll And I'm studies. so But having have sorry. across that that's clearly, our more thing -- activated to see another

Chad Messer

finish. Please

Rajesh Malik

No, obviously, factor no, to relative and clearly a response. is, good having more activated TREG antitumor CDX from thing cells

Chad Messer

say, Correct. to I'm going vast expansion excited available the about I in just to to was see we're data receive?

Rajesh Malik

Yes.

Operator

Ed Our from of comes White H.C. next question Wainwright.

Edward White

make I just I sure right. So heard want this to

of kind first are in the in data but by the with the second does after lerociclib 'XX, 'XX half I Is to upon the of study in the GXTXX, completion? that the is have So of Or half study enrollment Phase begin? complete going you date when half? with that second

Rajesh Malik

last on of oncology these II period is as depend studies, know, the it month recommended which, you would DLT So patient the a like in is dose, after Phase the enrolled. really identification

getting the we read II year. will data Phase dose in of be second the to out So the recommended faster able define than half a

year lerociclib plan, expansion the anticipate, that about starting well, GXTXX. is middle the So the combination next according and as monotherapy to if of we everything we're goes when

Edward White

And combination you Faslodex? data also will time, have by the with that on

Mark Velleca

Additional Phase data. I

Rajesh Malik

report also expansion to time. plan to complete around we that yes, -- we expect we that phase, that data The enrollment. I same Phase

phase the available of are we will not the by be end later next until track As this year, on expansion Mark year. data said, but

Operator

like no over for the are further back There to questions. Dr. remarks. closing Velleca I'd call any turn

Mark Velleca

out Thanks, in look Yes, additional San any you and at this questions. joining forward Antonio We December. evening. Conferences and everyone, later Investor Jaffray thank for to us you. call. the Please reach ISI good month Stifel, with many Evercore Have Piper of upcoming the to seeing in a

Operator

gentlemen, participating all Everyone, conclude you and in today's a the and This thank day. have you conference. Ladies may program, for does great disconnect.

G1 Therapeutics (GTHX) 11 Nov 182018 Q3 Earnings call transcript