GTHX - Earnings call transcript Q1 2020

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Operator

Good afternoon, ladies and gentlemen, and welcome to the G1 Therapeutics First Quarter 2020 Financial Results Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. I would now like to turn the conference over to your host today, Mr. Jeff Macdonald. sir. ahead, go Please

Jeff Macdonald

Medical Good provide Quarter and On XXXX Chief with Chief follow-up. Malik, Mark Angela. R&D; to Vice GX Jen Q&A overview and today's to of Therapeutics Velleca, Moses, Chief Raj Officer; First Corporate Officer, Executive and afternoon, you, Senior welcome President will everyone, Financial the call, Officer an Thank Financial quarter update. the

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

over turn And Mark. to I'll the now call

Mark Velleca

and hope first our an evolving quarter are our and afternoon, how we'll environment for provide achievements you update you Good everyone, navigating are After we first On discuss call, review COVID-XX well. questions. prepared the in call that results. thank remarks, Jeff. open key we'll the Thanks, our and today's us. your quarter, on joining the for We families

can in COVID-XX is field, that remain even the patients others in we aspects therapies affecting care. of many health our to in The Like pandemic circumstances. benefit than lives, nowhere these more committed difficult advancing

their thank to company high people for passion cancer. patients required drive bring to to has employees with dedication continuing Our execution forward. for for the to new like maintained level our of and entire and collaboration and team I'd therapies our

to proactively-administered population. make trilaciclib possible. has to potential priority trilaciclib for quickly vulnerable chemotherapy-induced first experiencing the these myelopreservation patients highest as Our be And myelosuppression are therapy especially patients. to as is patients the Cancer available

patient-reported received who the the range with a and trilaciclib are in types solid experience, and patients potential settings, every time that outcomes longer. time help have that they improve live of patients trilaciclib chemotherapy tumor trilaciclib shown for is Clinical the safer, patient across data vision treated and broad make first Our some to chemotherapy. has

new interactions. in enrolling cell it The an FDA fourth XXXX trilaciclib and quarter application, for quarter. on done COVID-XX in meeting pandemic, complete sponsor this placed with began while small or on job lung We the also NDA, outstanding the the demands keeping the drug are of track to cancer filing has by of pace

of third trend we of our acceptance the Assuming assignment NDA quarter, date. this in anticipate continues, including PDUFA a

data designation in a on we X As small the based trials therapy compelling reminder, received cell lung myelopreservation across trilaciclib breakthrough cancer. for randomized

our patients cell work trilaciclib cancer. preparing small on NDA, to the available with with part make we In to broadly are lung

with engaging medical and Our myelosuppression reactively providers care induced health chemo their to managing liaisons are current to complication. science better with its understand virtually experience approaches

On the Chief the Soma in trilaciclib. to excited Gupta lead our GX are March as of that side, Commercial joined launch commercial we Officer

launch a health also is Pfizer, which at background, emerged patients, will led the continuing previously significantly responsible patient-access oncology preparation for therapy commercial having patients is team the has of highlight care are led her She Soma for Under has Pfizer's She and VYNDAQEL oncology most system. and for reimbursement advancing XXXX. initial global strong the an pricing, global that the strategy early expectations. recently a in for as refine potential and oncology practice sales of a strategy of commercial our development launch centers in important we leadership, portfolio. outperforming benefits to trilaciclib

of progress more detail half in the commercial our out in plan as from expect Soma the on can roll second You color greater our year. we

demonstrate to has the outcomes Small on cell opportunity potential data, multiple the lung believe mechanism can across clinical existing to value our provide tumors and we patients. the solid trilaciclib preclinical Based trilaciclib chemotherapy cancer regimens. improve and is first and

We will in shortly. program detail Raj indications, discuss robust evaluate have which more additional development a to

also our we'll Pfizer oral of notable And made in nonexclusive CDKX/X XXX SERD monotherapy inhibitor our select supply progress is future with decision rintodestrant milligrams in the informed which under from on evaluating in this a the our rintodestrant. agreement. the being palbociclib, have have dose provided by as We go-forward to development ongoing Findings combination beginning trial quarter, trials. be

enrollment The to to I quarter. been the filing development with initial make trial for our timelines pipeline. for quarter, We impacted trial keep NDA I'll Before across comments starting FDA the we the interruptions X the business to patient recruitment COVID-XX will anticipate this trials no X or track. remains regarding regarding a pandemic. every the making I-SPY our trilaciclib on and turn are effort combination be over track on had plans are to additional scheduled the relative this Raj, call submission our that operations interactions few rintodestrant but trilaciclib on There

and minimize not monotherapy working supply chain significant anticipate sites We fully and with or shortages disruption. our we rintodestrant CRO do enrolled, ongoing is Our delays. trial are partners to

and to development I'd now over like an for to update call programs. the on trilaciclib Raj rintodestrant turn our Raj?

Rajesh Malik

good afternoon, everyone. and Mark, Thanks,

close trilaciclib cancer. to we in As NDA completing for are our small cell submission lung Mark noted,

and myelosuppressive, myelopreservation. patients. combination FOLFOXIRI X-FU, used to regimen Phase fourth as with on with the is particularly explore year, may neutropenia. such trilaciclib focused plan trial GI oxaliplatin This treating of contains highly full quarter chemotherapy continuing regard a in use We cancer. and cancer malignancies additional a to This trial for tumor III irinotecan will regimen colorectal also benefit in endpoints primary types this initiate where to colorectal are registrational We

the many used in preclinical myelopreservation was X-FU trilaciclib. of studies that shows our benefits of

FDA once data advancing Phase have from we'll and details finalized. protocol cancer, pre-Phase to We more II breast meeting based triple-negative on survival trial. the the discuss cancer trilaciclib is trial a We're our the with completed provide III the design, also in breast

classes with trial combination trilaciclib examine the will used trilaciclib X provide and data for arm several all I-SPY an I-SPY with will broadly Later trials. platform with ongoing subtypes I-SPY immunotherapy. the cancer an academic trial in II our consortium This trial established Data will run breast use open. in ongoing this X us chemo sites of and TNBC is the trilaciclib and future from cancer Phase X in a of also by of quarter, place. anti-PDX breast inform trial

the updated to fourth planning survival the trial We of are quarter TNBC in from XXXX. data provide

to I'd commentary community from a has myelosuppression highlighted chemotherapy-induced oncology cancer trilaciclib and few relative about COVID-XX crisis patients highlighted especially vulnerable, burden the the the managing recent myelosuppression. has experiencing ongoing comments that also to global pandemic. This of like make are

such the as important fact, has higher that In blood recent reducing on care of with broader call noted chemotherapy-induced COVID-XX complications NCCN risk, guidance myelosuppression infection for health and address changes an supply after the limited specifically chemotherapy. to goal practice clinicians from strains how system

viewed this we have care, into myelopreservation patient While need has sharper the advance situation of focus. benefits trilaciclib always the put as current important an in

This rintodestrant inhibitor Turning XX in daily. SERD online patients arm breast alluded to palbociclib, now quarter, with oral as include sites the XXX-milligram coming commercially as Later our Ibrance. the HERX-negative we Recruitment CDKX/X I/IIa the approximately currently combination our a earlier, begin expand involved to monotherapy rintodestrant. an arm plan of and Phase in of an second cancer. evaluating more will second our to known at patients Mark rintodestrant trial to enroll will dose sites will half year. receive And arm ER-positive once in with of the

year. COVID-XX, we impacted by early will by enrollment enrolled fully be anticipate of be the likely end While trial will the the

of to also in out reporting the XX monotherapy like point now for and fully turn I'd fourth of trial financials. the a Jen? year, enrolled the data safety from efficacy call arm we quarter anticipate of patients last Jen the to to the I'd like over was rintodestrant that all and XXXX. updated review

Jennifer Moses

$XX.X first XXXX. Operating for of first expenses of review $XX today's reported to for were million several for Full call. first net first XX-Q. of of our on quarter quarter loss million a the for We XXXX XXXX compared the Thanks, in available the Raj. I'll release quarter million XXXX first to million financial quarter items for the of and $XX.X XXXX. are press $XX results of compared the quarter

operating clinical and development for Research compensation of expenses an were in for first $XX.X million million quarter and ingredients. to first the compared increase due costs XXXX XXXX. to $X.X first costs for included to the of program GAAP quarter of of $XX.X quarter $X.X compared expense active expenses for pharmaceutical increase million expenses of million the in was The XXXX. primarily quarter manufacturing R&D stock-based first for the XXXX

in increase and $X.X increases other costs due fees to XXXX General support operations. G&A $XX.X the due expenses headcount, first medical largely quarter the quarter was costs additional compared and affairs XXXX. administrative in to of precommercialization of professional The necessary our and were for million for activities, expenses compensation to administrative to first million

of equivalents we $XXX.X as XX, of December XX, $XXX.X sheet in the million cash March cash million XXXX. and from As had XXXX, compared to balance

the between million to our operations and reiterating We is ending $XXX expect of XXXX in equivalents. and sufficient $XXX position into cash cash fourth are our current of support guidance with million XXXX. quarter cash And

discussions capital this several nondilutive In fronts year. on addition, to advancing in we calendar are bring during

XXXX. capital consider or from Our of current inflow does partnerships, realize may collaboration not in activities proceeds other guidance any we that

call I'll turn back now to Mark. Mark? the over

Mark Velleca

Thanks, Jen.

of submission breakthrough the NDA lung trilaciclib pending this the bring to about excited near-term cancer. and with therapy particularly are to patients small cell We opportunity

potential well and and development. regard in has tumors among education evaluate we the believe additional potential therapy underway, this in and rintodestrant, to best-in-class benefits trials oral different chemotherapy preparations in continue will SERDS the are of trilaciclib regimens. to medical With invest other Our to with commercial we

based go-forward on inhibitor initiating and the XXX from We dose with a ongoing of have trial palbociclib combination selected are trial this monotherapy quarter. milligrams CDKX/X our our data

presented monotherapy Additional be efficacy data fourth from the arm will safety the and quarter. in

the these the milestones a updating are year. to and corporate regulatory, to position in clinical on strong continue patients investors of behalf advancing a second and therapies of half forward of number in on look We

care pandemic. essential of like are go I the providing we to professionals Q&A, Before through would the COVID-XX services acknowledge who to all health

of the have time. behalf have On dedication all to for during of with support making compassion oncologists, privilege teams challenging patients. collaborate everyone you regularly. so GX, Never patient and We you and are us thank been sacrifices at this of for the appreciative nurses for their we

concludes call prepared That please remarks. for our the questions. open Operator,

Operator

[Operator Instructions].

Leone Our first line the James. comes Raymond of from question Dane with

Dane Leone

you some the in I get just the have for you'll updates, are guess, I the of going update what with and with rinto, on just two would for, looking year? palbo to the the the progressing. wanted hear of plan what updates One, of then combo program kind do later to Good context terms for any And that to from development monotherapy then confirmation And lerociclib is updated kind thoughts business do be things. plan in on one, things secondly, front? well, what this -- of the forward?

Mark Velleca

Dan. last the end start It's I Thanks, enrolled Raj take Yes. with monotherapy the chime in XX at Mark. I'll in, patients fully rintodestrant. We but can might that. of year.

and move the data have decision We with milligrams. hand, that forward to informed XXX our in

with them mentioned. the data, see You'll we'll fourth you in as palbociclib the And those quarter. forward share we're combination, moving

far benchmarks more This similar to a that, As patient it's as population. sensitive endocrine for really is POLOMA-X.

next that gets response So and those we're is looking dialogue would some starting inform And fully so at when rintodestrant. trial rates which that year, mid fulvestrant, our similar to have could seeing we be partnering this assuming palbociclib obviously with assumption. data, be that in plus we the have CBRs enrolled of that year palbociclib should

discussions. to partnering of are With a lerociclib, progressing number regards we

cohorts last again We that data were will fully the and year. enrolled for XXX-milligram the update XXX-milligram

We XXX-milligrams have That's our in the data decision dose. informed the that is go-forward hand. BID

we'll third in are discussions. present and of So a quarter number partnering data those the progressing

Operator

Shibutani from is And Chris Cowen. question your of with next the line

Christopher John

were IIs for you're on account is perhaps colorectal this about at to curious you'll idea in end This larger be chemo for endpoints been Would evening. the and initially of to for used also additional about focused starting With to the cell of like trial, lines. and size be there myelopreservation potentially some of cycles, Originally, II was we us like trials the Phase somewhat And benefits. that Chris had which this going thinking trial. this those to the more that we Phase potential this in respect how the with the triple-negative small going adapting thinking saw negative? trial whether be on look time Was then to triple it's something survival now CJ respect year. the giving for

Mark Velleca

that handle Raj it's I'll Mark. CJ, Thanks, question. let

Rajesh Malik

CJ. Yes. Yes,

details So Yes. the some small evaluated there we may so do ones we'll provide the study, similar endpoints will well be And myelopreservation program. when to we'll additional as the be endpoints, so. what cell obviously, in on

had with We meeting are pre-Phase we III already. this -- as I mentioned, the FDA

are, something that in efficacy tumor also. as of in We also as then TMBC interested in study at you, readouts study looking looking referenced this course, of well. we're course, And the interested

Mark Velleca

You to number the on Raj... want comment patients, of

Rajesh Malik

Yes.

it So survival, for designed study for more this several will will rather be that's be -- the really than yes, patients. example. A myelopreservation hundred

Christopher John

All right.

So we'll for all then? of need those myelopreservation endpoint the patients

Rajesh Malik

Yes. like There endpoints are that in a evaluates. a design, of there number -- study any one number are

which myelopreservation. the so going to is will appropriately designed endpoints be we study going focused to be the that on be, And evaluate is to

Mark Velleca

[indiscernible] just expectation it's the it's end point, and just a are again, to hundred CJ, said, patients. Raj early after another reiterate few available And -- soon in data 'X when what Mark our very

Christopher John

Got it.

Mark Velleca

registrational a pre-Phase is meeting. a III it's this obviously, trial, And

Rajesh Malik

right. That's

Operator

next Securities. Nierengarten your line from with question is And David of the Wedbush

David Nierengarten

I one. had

you of Obviously, bit If particular get for small additional file could there lung, add going colon a additional starting any indications Do perhaps and maybe of in potential in a and for kind cell the lay to us you a could steps out you're remind later? data where the as there to than for launch you sNDA trilaciclib? about studies sooner little the Are but breast thinking order cancer. label? through in you whole rather how anticipate

Mark Velleca

question. Mark. it's that Sure. David, I'll take

our Gupta, an call, at upcoming launch to about August going the Soma lot more from certainly, in CCO, You're call. preparations a hear

making are preparations a We that. number for of

cancer, out, To I-SPY early in your point we'll initially go is the will And review, will trial our registrational colorectal cancer. for As in cell that lung next read III the X and you question, it on breast we'll other it subtypes potential a trials ready be in small could both we very priority expectation neoadjuvant based we early to out year. Phase and all a as is available X be to that 'XX yes, publish an possible. be obviously, be trial, onward there quickly 'XX. About will to registrational from And those and years launch, sNDA from file as also us. since soon may that 'XX, present, moving run, be

So early again, and study. 'XX the I-SPY expectation, for X colorectal

Operator

with And H.C. your final question Ed is Wainwright. of from the White line

Edward White

sequentially. traditional the just mentioned had expenses was for year-over-year. a from also to the down trila. or preparation I launch? wondering virtually you're planning said are just also the Jen. the if going XX% or virtual for being you is I'm just why you're curious for just to -- to had then going So that planning you question on MSLs traditional a R&D are much it's just done of And so handling everything I'm you already why were noticed as launch up curious, down to be in for launch do if quarter. I'm last digital how that. type If it

Mark Velleca

the Thanks, Yes, do over foreseeable be the been. that part and the launching I are question it first looking it to will Ed, But drugs different than has it's of for Jen. Mark. then I'll turn we from very believe to step Soma. future about the we'll That an the the I a footprint up And the have be more have mentioned you obviously as that engagement. size question, on lot in effect will digital hiring on that prior field. answer of

Jen the So question. with for it over of the turn that, to I'll second part

Jennifer Moses

to change couple was large quarter. PDUFA million expense primarily That Sure. fee fee in a was rather a that in of we paid the dollars. Ed, the R&D due the fourth

main the of is that that so variance. part And

Operator

this Dr. Velleca further Mark remarks. closing the hand would no conference time. like I to now questions showing for back to at I'm And

Mark Velleca

Please Operator. to at Thank James to around today, virtually That joining month you call. any the ASCO with Thank you We questions. of reach many look concludes forward stay well. out us the please you, engaging in us mid-June. conference with Raymond for and this later

Operator

Thank today's you concludes wonderful this have your gentlemen, and call. participation, day. and Ladies conference a for

all You disconnect. may

G1 Therapeutics (GTHX) 10 May 202020 Q1 Earnings call transcript