GTHX - Earnings call transcript Q3 2020

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the G1 Therapeutics 3Q 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. I would now like to hand the conference over to your first speaker for today, the Head of Investor Relations, Mr. Macdonald. Jeff Jeff. ahead, go Please you. Thank

Jeff Macdonald

Thank you, GX welcome the everyone, Good third quarter afternoon, Therapeutics update. and XXXX to operator. corporate financial

today Commercial am Officer; also Chief Velleca, Jen Moses, Medical Vice are to Officer. Raj and R&D; me I Financial President Chief Chief Senior Officer Executive Gupta, Soma pleased Chief Malik, and Joining Officer; Mark of XXXX. welcome the provide Executive Officer Chief Jack Velleca Dr. as will to Q&A who Bailey, with we January quarter was On X, follow. succeed an call, previously overview announced to this effective

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

Mark Velleca

the second people enable your and us call, Thanks, to are review across cancer us. We this year will across and with of benefit initiatives range for focus Jeff. the well. a indications. commercial and joining financing afternoon, to that maximizing trilaciclib. regulatory highlighted you squarely today's team on our trilaciclib for of On On agreements Good you potential hope development that progress we we executed everyone, thank quarter our the partnering call families and would

And review open remarks, and the discuss quarter. call also will the prepared financials questions. rintodestrant we'll for for our We after the

trilaciclib from support commenting build CEO commercial XXXX, strategy lab functions to I approval, on patient regulatory for needed sheet to the by GX trilaciclib operations. to solidify up sustain were objectives transition. in the order start and and the balance in When clear, clinic, the a access company's to advance me develop Let our long-term ongoing joined the medical

thoughtful GX six work leadership I in talented transition. I've the GX goals. past personally rest Board make a all assume joined in launch planning the a our has the Bailey and for Jack GSK's entire R&D were blueprint Jack CEO as lead year, already this with the Board to successful right the With of selection now to of and launches role. of plus course in company. the company the is transition and an of plan his role In Vaccine for the of process. evolve involvement closely extremely extensive the the on the had that believe me for and and privilege an ideal oversaw leader the with in to had highly a to We Directors commercial-stage GX is fortunate years, providing organization. place, a valuable Pharmaceutical product to Board earlier were business as previous succession fit been is U.S., the familiar I Over planning and worked he we as multiple and to of strategic time team capable that on President have input we execution. those accomplished with ready refining the trilaciclib,

cultural call has transition that that tenure our to This of my as Senior I'm our outcomes of excited want shareholders past years Jack vision. a improve will thank an for on excellent working smoothly the going turn am for With to member GX Board I'd like that, future of chemotherapy. fit. call Just forward. earnings as I CEO trilaciclib's the Advisor the and The and incoming and and CEO last supported GX be GX, have a support shared to our been our current known going potential very Board, for he's and confident I vision And with so during than as shareholders, to having him CEO, five importantly, more steward Jack to and to be and of all who leader to patients present, over find superb receiving Bailey. you'll Jack his

Jack Bailey

your this been of Thanks, more and our Board you to Board as work. to closely the that determination therapies. trilaciclib. this you, the approach launch progress great appreciate with I'd to the and patients a bring of their of execution trilaciclib for we on the members And community, as potential to everyone. of sharing To we colleagues the finally, like GX confidence to new in approval for my To advance and rapidly Mark member, And to rest make cancer treatment. Mark. excited I in investment introduction. Directors I care I've the opportunity collaborate the of the with start, afternoon, Good with and impressed look of dedication me thank patients to and forward as the I'm lead it standard company,

program. We continue development our to advance

noted, joining commercial in GX, of U.S. Prior Vaccine president was Now spent roles. most as I to the of and GlaxoSmithKline's business Mark I've my in Pharmaceutical career

ready trilaciclib market and get During eosinophilic as mepolizumab like like, relevant number is launch drugs, both that we much changes asthma innovation, treatment represented Products will. launched which oncology, disrupting time, innovative in we to paradigms, and a clinical step severe trilaciclib. in BCMA for of very

company's served GSK’s the committees In investment addition, of many on for allocation I for R&D budget. years

both ensuring of. execution with, plans and familiar robust the I'm criticality of resourcing recognize So is development something and

type I energizes really life transform experience. science chemotherapy XX-years truly the a for In why this the fact patients. to that innovation nearly started excited get help to GX, ago make reality to of industry is I'm and bring This what to in potential trilaciclib me that work about patients. of that's to

Priority Review, in Designation Therapy of XXXX. of in and to received the assigned was our a headline date quarter, XX, to Trilaciclib trilaciclib FDA PDUFA which turning progress XXXX. Application, action Now Drug Breakthrough the was the New third February acceptance

of been assumptions planning XXXX. our high potential Review, likelihood So, first in of on Priority a receiving have quarter the and a approval predicated

work commercial this and in more and respective are their Raj availability XXXX. the working their commercial in QX continuing medical later color initiatives of provide that call, both teams are around teams Our will on. and strategies in Soma And anticipation

We group dramatically are that from these excited the which But about experience the near-term trilaciclib. community, for lung opportunity this the to small may bring cell to to chemotherapy not benefit patients. the is only that cancer potential therapy has improve

cancer committed and that anticipate to FDA of patient moment. metastatic After the we initiate which first planning findings CRC. trial trilaciclib to the support read label enroll trilaciclib In out We survival just this trial data Raj tumors we patients breast and provide endpoint. evaluating in expect that are detail multiple in trial solid will end, quarter are more in trial, the with filing from chemotherapy the supplemental Phase X to colorectal include To across to the primary the regimens. to this different XXXX, XXXX. triple-negative a trial NDA a on will metastatic with in expand to registrational that cancer our

further tumors We of trilaciclib’s would treatment. in eligible for expand other would benefit be number are committed evaluating who also the to patients that

rintodestrant. SERD Now turning of oral the development to

to in have CDKX/X COVID-XX timeline despite were rintodestrant will with There to presented completed trial. accelerate combination X/X trial able our recruitment evaluate months, arm by in our this clinical investigator that the And palbociclib. has trial was We several of we challenges the for interest recruitment inhibitor Phase the significant enrollment. that

turn pandemic. comment operations on I relative COVID-XX to before to our Now make the call to I the Raj, want over a brief

trials the to see is not monitor did we for on rintodestrant report treatment impact noted, an timelines if I've determine and will the COVID-XX We trial. As all on delays. in having material active impact recruitment any the enrollment

issues. meet demand manufacturing supply of in and in trilaciclib context XXXX, call, the and environment. the have Soma will trilaciclib the current Later on the discuss contingency approach in risk place the of of clinical commercial to We production launch as as expected adequate future our to any reduce of in to plans commercial trial well supplies

the the Now for rintodestrant. to Raj I'll both call and Raj? over and clinical turn to trilaciclib update share regulatory

Raj Malik

start everyone. trilaciclib with NDA. good afternoon, and Jack, Thanks, the I'll

As Review we date a XXXX. PDUFA February and noted, Jack action XX, received Priority on

a from seen normal constructive not timelines. continue dialogue the with have and impact and we have on process review agency's to-date We the any COVID-XX to FDA,

for for two most of benefit the all first benefits, additional lines And potential could cancer when the chemotherapy also first receiving become first treatment. has number trilaciclib of is multi-lineage time outcomes extensive and line deliver etoposide disease. an cell used in In nearly to stage three it largest patients which the into platinum-based in of small patients is first regimen, standard-of-care therapy. key with lung for every trials. lung not regimen on affairs time will in but if cell its small patient receive focused only patients a chemo to medical the preparation approval, The is is used for of important treatment our Given patients line could first believe given, trilaciclib beginning for line initiatives. We team the line, be moving and is our marrow cancer. bone improve these Protecting

adoption Inclusion first practices. guidelines guidelines. in Our initiative is is clinical critical NCCN and to the treatment

for approved small following to the the request in those inclusion regarding have be to our provided submitted guidelines. notified approval, Factors committees on evaluate lung formal trilaciclib. have date, insert guideline a package Haematopoietic including We trilaciclib PDUFA Immediately cell and cancer data FDA and both will Growth NCCN,

Our second initiative scientific is discourse.

data publication Cancer cancer that American a data analyses Lung will several to a robust And medical Last trial week, at we in Congress next, plan research. lung support our presented was published data month, clinical in this lung year the be randomized ranging presentation published. of patient second/third-line we on health have outcomes economic have our analyses on from North trilaciclib small-cell reported new this and anticipate We review and of cancer to and and education. manuscripts outcomes small-cell we

medical throughout We trilaciclib for on XXXX. additional analyses will presentations at conferences submit

is third initiative professionals. to outreach and healthcare Our KOLs

chemotherapy science the well care metastatic pre-Phase in a is FOLFOXIRI this we feedback medical small engagements field-based We extremely combination The they based patient cancer. metastatic with. advancing are next parallel of a academic particularly understand are with robust trial on as as neutropenia. lung The MSLs cancer oncologists, approach nurses managing majority effective completed and colorectal as with with regard treatment community to into indication work liaisons better a concerned and development team our receive X-FU earlier and combination their to myelosuppression In that most first-line most plan. are the have with Our pharmacists chemotherapy evaluating we having KOLs protocol. X to their of or meeting And cancer, myelosuppressive, and regular gaps cell FDA incorporated to is the are patients colorectal year.

trial an complete myelopreservation, Enrollment induction of measure treatment, weeks. to several pathological XXX next track of response measures the the discontinue evaluating treatment. assessed. setting. trial regimen. enroll being area colorectal line trial, survival and patient will randomized clinicaltrials.gov a treated anti-tumor trilaciclib website. funnel the in this potential for in this available receiving efficacy. trial on followed cancer. on chemotherapy outcome the details timely are either of We is for outcomes maintenance patients The has in randomized also goal to the through safety, potential with until FOLFOXIRI trial breast view More the anticipate in as patients placebo-controlled be will reported on trial enrolling with patients metastatic We is improve receive in and ongoing We rate approximately first they for this all cancer with within trilaciclib protocol being to enhance neoadjuvant are the first to in treatment I-SPY where addition phases patients tolerability, the phase the the chemotherapy or in with to maintenance placebo patient A Patients participants trilaciclib

Phase survival our Next month, cancer trial negative triple metastatic breast in X mature Breast Symposium. at present the overall Cancer will we the Antonio data San from

of breast positive this design cancer As We registrational concurrently in on metastatic initiate the update. commercially inhibitor oral a ahead to our enrollment as plan trial overall or we'll the Because initial in data Oncology. tolerability published on clinical to three including the months. data Phase clinical our enthusiasm efficacy a SERD monotherapy following were safety work team, were fully and able in Congress enrolled ESMO the the in a data we to arm Phase XX second and X/X, all more details XXXX. we palbociclib, arm like triple dedicated rate evaluating the schedule, complete complete XXXX. benefit Antonio in and reminder, completed CBR survival Antonio point approximately provide recruitment enrollment are was at Lancet the our Cancer additional And call we XXXX of trial presenting updated anticipate trial at patients to and patients operations The the initial Soma. now With last based quarter XX-weeks turn presenting San of negative of presented in we I'll The of this data, able XX of to Breast rintodestrant in investigator and upcoming rintodestrant, were X efficacy San combination October, year, from now and known Ibrance. that over to enrollment regard accelerate CDKX/X I'd out Symposium. and XX we at of

Soma?

Soma Gupta

Thanks, Raj.

expect we indications. prepare will of this Jack the both in launch first we and multiple be of the as So Mark mentioned what an trilaciclib time exciting is as

on at launch are organization to working for to trilaciclib. trilaciclib We place to three to and first, areas field commercial third, small approval. healthcare cell the and system; patients state are we education have broad Ingelheim’s second, introduce a best upon strategy and to patients; the trilaciclib trilaciclib excited strong and are: on in impact to with of we be in are for have access sales myelosuppression and GX team we successfully launch highlighting The lung the value patients our focused completed team advancing bring ensuring disease simple Boehringer the ensuring building cancer, of physicians and the critical

a moderate boards oncologists to preparations, oncology as XX% a impact We market completed over extremely for XXX patients. As need nurses about in to understand part of a quantitative pharmacists. we on oncologists believe of order with better a of negative quality unmet patient's myelosuppression the research, and advisory conducted found amount that as of recently launch has chemotherapy-induced life. well of survey We've have our significant

cited other therapy, change of with differentiate the In Nursing through which as surveyed, which that LUNGevity. we're firsthand. interventions multi-lineage and of pandemic. or most the in clear heavily advantages including myelosuppression used increasing contact to of with patients before extends to engaged advocacy many represented consequences trial from trilaciclib treat effects standard-of-care, oncologists state disease campaign over This built marrow, due myelosuppression commercial the not only value several a concerned patient the been strong to the who impact the more lung than so, pharmacist, is oncologists need addition, healthcare on professional profile. the the damage do Oncologists like vehicles. have had FDA XX% trilaciclib prevents to COVID-XX to to now Trilaciclib support trilaciclib's awareness myelosuppression online chemo chemo-induced they reactively and an about about chemo-induced receptive Oncology critically, extensive organizations additional communicate to recently we care regimens indicate the but of myelosuppression audiences launched Society will mechanism, education features online and the tolerability of programs of such with also out is of a nurses, its groups, covering experience. patient to vast findings, cancer majority staff and by and perhaps and most see from designed key will CME encouraged myelosuppression and small-cell to be the of GOX the investing rolling prescribers myelosuppression reactive preventive. Foundation educational approval. key cases are which ready a trilaciclib. and in the We're safety upon We've also organization, professionals We've these and We're more disruptive of and treatment proactive learning to mindset To current

this sales cover key small-cell existing adoption, -- that are At other an market be we access, care of fully G-CSF Our centers our are our as will see with sales which Having and been about. and/or Boehringer services, to functions patient those managed touch based launches. been experienced in team of supportive accounts, critical to based physical on their want advance era, gain operations, launch, now virtual leveraging on such to teams especially robust treating as and in core input use the team particular teams. limited will access working individuals to priorities, force We've feel community on and who've training collaboration the practices state disease which in the the channels, more alignment have opportunity and profiles, is anticipate being lung in excited for instrumental talented leadership begin relationship tools who X,XXX oncology onboard customers, to together the and able knowledge the patients gain based place potential oncology of cases. we with launch a experienced by team's also their oncologists COVID sales history access We the through had BI’s with confident from well as be has therapies. highest lung approximately far be for marketing is concentration develop Ingelheim, our sales our will foreseeable their of criteria account really preexisting BI able their has of pre-launch account we on In to own access adoption multiple launch early prophylactic and the oncology get critical. long-term on on salesforce relationship the preparations. novel future, be majority we'll team for of the highly on I focus early been selling will easily how cancer sales as We have relationships.

have for easy prescribers means area third to and optimizing is office’s the it focus experience, of Our to staff trilaciclib. launch access early which making

to novel great with to every use over ensure time. a this which will has first experience treatment, Our lead job expanded is practice

the meeting of have majority busy integrated access networks group seen. are community delivery the where with setting purchasing market been organizations, patients access which are and know treatment critical to teams Our we in vast

addition, formal upon we decision-makers the price. Payers extensive need we beginning payers on discussion based recommendations as key well with be as a and build medical will of level summer to that feedback are to oncology exemption. the with to course at meaning product, our bilingual be the it amassed hospital are would of In trilaciclib a Prior acknowledge business trilaciclib addressing as will added a inclusion will information to XXXX Trilaciclib final practice expect committee’s or C-suite advance formulas policy, a we be we in the via drive per pre-approval available population CMC medical in purchase discussions over exchange need. have over receiving reimbursement. clinics unmet pharmacy

are programs we support on that planning mind. So, in with

commercial Our comprehensive the feedback by now, I'd And and and receiving Overall, encouraged support Jen? prior and support. from we're call Jen. launch as we're hub very about to office addressing prepared early support well XXXX. over to will investigation, like a benefits quarter first the sales staff to the assist as authorization requirements stakeholders trilaciclib turn

Jen Moses

license Thanks, press results I'd respectively. Today of the We $XX.X from EQRx quarter to million like quarter few are and third Genor and for on from recognized of the release primarily in XXXX. third the was XX-Q. a payments of disclosures. our $XX driven for financial focus upfront and XXXX million by available revenues million Soma. Full of our key points Revenue $X

to quarter revenue of the Simcere fourth partnership recognize related XXXX. in We to expect our

on XXXX, with and Simcere. balance the Hercules XX, XX, proceeds compared we agreements September This million initial our million and financing, and as cash sheet, Genor total drawdown $XXX.X from upfront of to an $XX million of cash cash had December EQRx, $XXX.X equivalents our XXXX. from As includes in

our to between takes from BI we expected Genor and into agreement our lerociclib to updating consideration driver with additional of of million realize million, supply effective with guidance $XXX which and million more $XXX up cash for primary commercial the inflows to and The outlicensing guidance savings are finishing from with previous the cost as our is XXXX and of EQRx. expenses, cash agreements million. on well $XXX related $XXX guidance interim expect updating We nature year our clarity as

cash of million. current we to include our and expect into XXXX. When contemplating licensing debt runway drawdown have cash and operations our XXXX, we $XX we disclosed, support previously payments received As collaboration into to-date

all We are for accounting and our to related expenses launch development program. anticipated also trilaciclib expenses

not we that to agreement reimbursement, Hercules from not the does additional capital of runway draw inflows realize, generate may cash the capital we from Furthermore, current guidance reflect consider cost on does or our have we trilaciclib that milestone sales additional ability XXXX. guidance in in revenue beginning includes place. Our facility other or any down of proceeds may that our from additional payments,

these the items of beyond extend I'll cash Jeff. Jeff? call would given today. All further turn to now runway our guidance back the

Jeff Macdonald

Jen. you, Thank

excited much-needed highest it’s Our lung plan about available possible. runways and can doing small-cell that With small-cell next patients, they tumor our focused laying to effort opportunity as complements are cancer to priority successful types quickly next This the team the discourse will patent a additional lung trilaciclib future to on experience make the is the trilaciclib a the how will on in indication professionals generate XX the over XXXX it in to gain into for therapy mid-XXXXs, for indications. are scientific early work and development provide commercial as patients robust first commercial education. to as uptake launch the with deliver Initial patients, to of year. and in XX quarter healthcare potential firsthand We're as of foundation data months. medical their this benefit see executing cancer

opportunity the same use the of at create for time, their for therapy. benefit for this shareholders patients, value conviction have We and the in of expand the to trilaciclib significantly

potential to best-in-class the data rinto/palbociclib combination and XXXX. of quarter in second a continue disclose rintodestrant We oral therapy view our SERD to as expect

please teams moment to that with health to provide gained have neighbors. for frontline to are are workers, to members and concludes Now, the our continuing those want oncology on go the for we recognize healthcare take as before been of families, even prepared remarks. professionals our all of deeper have particular, appreciation services. focused Q&A, do our an Operator, of That who friends essential and line open I community, working a the questions. we In

Operator

Thank Macdonald. Rama question Our the line JP of [Operator you, with Mr. Instructions] from is first Anupam Morgan.

now is open. line Your

Anupam Rama

so the question. ones for Thanks guys. quick much taking Hey, me. from Two

First trilaciclib there, expectations? the positive as what's would recently awareness like the of win of question, analysis relative for your mind the rintodestrant internal American are the about the point you and NA at, the of were just and update you -- Thanks San how to, at in kind physical would scenario Antonio of -- where December, you characterize so then Cancer the on awareness much. thinking awareness like of and at what's you Lung meeting sort second And in drug your kind to Meeting physician drug the a there? medical North

Mark Velleca

Sure. the take Antonio. to one I'm Raj on first have San going

Raj Malik

Anupam. Hey,

So, expanded we two presented escalation that combination. and expansion, be dose and data forward as the at took levels dose we dose as the San monotherapy at well in will then different from Antonio trilaciclib the the recommended the data

So, also it we're year, the be that excited and Those data a pretreated showing that months, very patient very data, palbociclib. continues to evidence in we of very competitive, profile important those for next at be with potential quickly partnering time. and XX combination look look enrolled could in which safety patients populations. forward three seeing additional And to efficacy safety will about activity heavily an

the Regarding at question your Lung North Cancer American Congress. second

hospitalizations, new we where oral presented important the we which, findings, an significant data, an are where had economic from reductions chemotherapy-induced presentation myelosuppression pool using of also also standpoint. we very saw in sepsis, course, in of So

also work awareness, something continuing this this clearly, to on. as maybe is In Jack that can are we terms area, of in comment

Jack Bailey

questions. both Anupam those Thank you for

with I we've the the program here think right this to of on. also question disease education on team good discuss, we I feel conferences think it out awareness traffic front, months with your is what think, level medical there we just the now, I awareness, got is to getting in ago started good be the various that online on core of Obviously, an terms think I like several honest.

at try you is lot market this to once to look signaling approved. oncologists research, are If it's of real us our a willingness what their

So, our the approval. where But we feel right organization we're online going efforts, other medical good both we're now. the like through the continue with things at to obviously, up with and until

Operator

of & Co. Your of next the from Cowen question is line Nadeau Phil

Your now line open. is

Phil Nadeau

I FDA the we’re of or just FDA might the PDUFA. is one an from trial, that months guess away review update necessary? over on three could the Any indicated as first be on outcome,

Mark Velleca

no that Actually, will is there required. they have be that indicated outcome

Phil Nadeau

group have year second prepared DRGs. that it it on for work first to I post guess Perfect. in within you you to reimbursement remind it's B. approval, And then us like incorporated trilaciclib your Part is remarks Can Medicare from how sounds launch be the likely some of be Presumably, approved would of if is in February?

that to have payment next an Or it is it does possible wait to for year? get how years? and work So does NTAP subsequent

Mark Velleca

for Phil, question. the thanks, Yes,

it the drug. defined is B On a -- reimbursement drug Part

for Part years. the That couple B of So, in file Medicare last terms of refined process been has a we'll process, the J Code. over obviously,

be will in been it it the past. So, has than quicker

-- dictated file In a that take NTAP, little we you're will will did obviously addition, longer, we correct, bit an and bit for slower a schedule. it’s little

those play relates as So, to come both it of reimbursement. will into

hopefully most of those have part in formal commercial overview the the an it and cases, a done. medical the payer then organization it'll policy, until still side, On various teams of make obviously, of be exemption

Phil Nadeau

within have for you revised themselves of them will adoption? to of protocols level amount the their fair handled? institutions the to can institution, you how individual myelosuppression before get Or myelosuppression have At is discussion a is there

Mark Velleca

it those. guideline of We would organizations, and on follow guidelines with Clearly, have about put just comment may with major overarching organizations that the in over are and But will to at, who quickly that, Raj Raj, large physicians to opportunities team to other just we community NCCN included point, majority practices. both possible just working guidelines as and can to an various supplement. will do dig be I as anything Yes, then Soma mentioned, key I add? turn whether there add looking you because for these your we'll into the both different will Raj training be engaging that. individual a account have certainly like vast

Raj Malik

Yes, no.

going our Soma, exactly patients is community being terms physicians as like I of these important and really think on that Soma’s team as that for be we with terms in you'd side, to and practices, trilaciclib anything of team, come having the mind think to of right large well are well particularly nurses really medical as in working the education And as maybe diagnosis. in front add? following that's

Soma Gupta

only a little will, which out regimens constructing it use, as kind otherwise, the EMR will for if reminder while will think kind small there it a cell is, of patients. which be into the think get I opt the to I a to of thing, they're or system, think I really serve small that opt in as will you of lung cancer take therapy

said will remind important is that think to I to consider be to nurses prior that's Raj kind I of physicians So that think really what that, vehicle it.

with work there. the key a to of nurses the very us And so, strategy is that's for and partner part

will ones my the believe really that in consequences to So, we remarks they the I earlier myelosuppression, as motivated action. and of right, said see are be take

Operator

Tom Shrader have we Next of BTIG.

line now Your open. is

Tom Shrader

Thanks the taking Hi. for question. Good afternoon.

been the tireless keep I'd effort to subtle. like to data on thank up-to-date us So, pretty Mark for that's

I lot. you a wish luck. So, thanks

a have forward, Going I question. bookkeeping kind of

you you're that if clean a deck, XX, to there Slide table on trials So, able up your sort data. and succinct combine myelosuppression that's that beautiful you a that is So, agency? very X-line confident able that Do like, at come if a combine with slide will work-in-progress be will your of be the you'll to or clean, look know all look with it myelosuppression where is everything? it's you what clearly label are the

Mark Velleca

going Raj Thanks that. I'm to have respond Tom. to

Raj Malik

who to it us data. actually just So, Tom, remind to the was the combine had agency asked you

Tom Shrader

know. Yes, I

Raj Malik

value label really negotiations it NDA right. for have -- are get of so strategies various trilaciclib that's as And through into obviously the the you to so Yes, -- ongoing also we appropriate patients. the but and review so communicate data know,

Tom Shrader

Okay. Soma. And one just then question quick for

worried users key thinking comment areas they're the be myelosuppression there there surprises Your any to talking Are should that of we about. about? about about

Soma Gupta

think So, so. don't I

we that there sometimes think think But -- thing it's definitely we've sometimes think about a that's about heard fact surprise, on, affects So they -- don't and state is the obviously this there's obviously the neutropenia, thing, at they one that I around one not know has basically disease they effect that think all. think education been doing about multi-lineage aims and right, when a about that that educate think effect, the to myelosuppression, this. is when benefits something I to multi-lineage right? is, they the

So it. to that say there's in me, I a wouldn't surprise

that pretty that and is that education. some I it's that, neutropenia is myelosuppression require -- does thing, more prevalent think a think they think people

Operator

of Next we have Nierengarten Wedbush David Securities.

Your line is now open.

David Nierengarten

we're their you as want to in mistakes marketing that launch new learned there in of any to that whatever or in that de kind we're and assuming now products? any a still are you have BI, -- of discussions spot do the lessons wholly a wall companies Are convert, the companies some either to your same it quarters that talking outside and a you've had or virtual or off can had we've I obviously, things launch had you apply, when call there a virtual novo that environment Yes, little or couple for or product trilaciclib? question. commercial having

Mark Velleca

to it. to will area do of oncology I'll couple we COVID I situation was the comments is of is the that and one add make unprecedented. words David. Certainly Soma pretty What Thanks, a ask know restrictive selling, around that's only restrictive, of the the personal data some gotten others. obviously, more because IQVIA of and time of by time again shown the and your concerns COVID. terms It's been in most

key. having organization able by being look Clearly, to personal questions oncologist practicing supplement things that to selling. the So, critical. like arise community absolutely content the digital access a ways is good to medical at is a the other for oncology easier Obviously, may

things really think do but prevalent approach. trying COVID, at like looked has the what is digital I also with both traditional, to So, we've what i.e. become

what then, is is it is. it So, it

provide all this, that to and want groups, in the there nursing be societies us as we're given -- access information we patient access, by time own salesforce going that are being of the not our small doing BI to advocacy the will would with work with think cancer have for to information. was efficient, building are community probably involved when digital, us access able relationships points that it that But these be supplementing cancer to capital I very at and the give on people cell the seek confident lung not it upon able building a access. to the has also

that. So add you Soma, I'll to to it over turn to

Soma Gupta

talked think no, Yes, you it I well. to

forward relationships talk a is one getting seeing before, we that this we're a was think access problem, was BI you've we this about could reasons me -- are did this short-term term was critical we in we -- because longer I to going think those the we issue. of to pre-existing think heard I -- started the this main to -- be And environment. not that but

will have about, they in, to the across. to then get So, channel, even able a get information if new if talk virtual be they will something it's that

August virtual we that perhaps think efforts that we're broadcast, think like, for I of companies speaker in partners fact the the middle is of and probably knowing we great convention we spring like of have their to spending the targeted important kind national that about also and programs, live time. I that our program, decision, had lot but going digital it of virtual messaging, one So, industry-leading launch the congress launch engagements a are looks virtual -- effort with have that be technology with benefit augmenting really made to that a kind BI equip we it's what winter feel

it dime kind we and just that So, to we having to change suboptimal of a a weren't on coming had plan solution. with up so we're maybe

actually execute also our if of approach really quite way. digital And will, where in to reps and bit to of a as to are. able built they course, are are reach you I customers sure think that digital, kind that for that is try done make we've Jack mentioned

social media sites leveraging can like where So, go the information things anyway. platforms, they that they where access actually peer-to-peer [on-site],

those to two digital of the recognize we -- give we this poses. to reps more sort between of it good really supplement that of kind ability in a that but But the things feel terms supercharged engage, think the their level digitally drive of to can I about issues with so, going awareness. support we're BI And to also

Mark Velleca

I David, good with. I feel model is, this is we Soma the shared, what both and think engagement

really being reactive terms has that moves of being tailwind which what take us rescue benefits the notion traditional we of to into trilaciclib. interventions a reactive from approach up tightening of that more obviously acutely the aware in falls think see COVID I providers can approach given they the applying clearly It preventative. with

we’ve seen of market the that clearly. out research so, quite come And

some This preventative So, you there COVID to benefits are the can as situation. you can in heightened has see patients. any assist steps to help that take sensitivity

David Nierengarten

Presumably NCCN that? importance increases guidelines, of how may

Mark Velleca

Go ahead Soma.

Soma Gupta

maybe an now, taking people actually mean, do gone preventative up shut-in, guidelines but just ad there that that number, to increased So seeing significantly. And informally, we even maybe maybe seen a we're think just of -- being then measures. an pretty it’s definitely have measures, is of having that is we we that board in prophylactic are move quickly, again, direction. no, in it’s kind is We've I who we worried, usage And heard when that, April people do talk to -- impact. an March, think

Operator

have Company. we Needham of Chad Messer Next

Your is now open. line

Gil Blum

for Good to you agnostic Chad. remind We is the starting Also tumor plan wishes Jack what colorectal. next afternoon there? moving our a is first much out a and trilaciclib best I'd for everyone. endeavors. be question. of questions. label. would thank know us in And congratulations into Gil to ask your for you to This required on How that like more Mark taking Like is kind

Mark Velleca

Raj?

Raj Malik

Yes.

So a obviously important it's used beyond mentioned, is an GI malignancies the colorectal because X-FU step based also as and across is there, chemotherapy, colorectal. I trial standard-of-care other

so example, gastroesophogeal, and for So on. pancreatic

because well. action think towards of and broader an looking focus be will those, are GI be And that that And to so, going aspect trilaciclib. Even important looking we important negative trials considering at that's model of anti-tumor on triple predominantly as efficacy, we're we've other beyond study some usage trial of to at those potentially the that another mechanism trials course, is discussed malignancies the already one also here. of of of preservation, stepping colorectal stone

Gil Blum

Kind of this me on led question. to next

data? that My of accounting any this overall a a study. is Would down safety there going some progression, of of is doses. bit increase on understanding to a So, this a drill colorectal the cancer confound of be potential the treatment for

Raj Malik

the Yes, that for increased actually we're was anti-tumor to play alone. that able chemotherapy breast right, could were in patients exposure the triple on negative given to saw better. in we actually pass cancer to also potentially colorectal something profile you're a in treat what scenario And the trial, standard-of-care comes also it role on the progression. is the where is was was very That progression. tolerate And chemotherapy chemotherapy another that safety And to is that looking efficacy, of that improving comparable which if in that trial.

Gil Blum

-- you combination maybe study of rintodestrant here. -- notice Kind It a that's to more to, maybe your that before? kind are were Is able during maybe an of mentioned combo. COVID. a you a of seems physicians this something quickly surprising, considering interesting -- enroll oral and more a pretty attention of not as something And paying it's bit

Raj Malik

absolutely. Yes,

which think sign think I the investigator with also interest. of rapidity trial enroll is trial. And obviously, enrolls wanting I the onto a to a patients

So completely agree.

Operator

Capital. Next ROTH from we have Butler Tony

line is open. now Your

Tony Butler

much. And necessarily speak thank could the how Jack site enrollments, related, it to about but that in in you have And you timing SCLC sites that? of open And wanted one again and would if is to today, speak I I'm curious I the you Mark, if say, I'm as but could noticed very welcome dosing in also wondered in increase. only part the seen you two CRC. think sort That's changed? you you may in wanted A. to but Is the to be or be I sort it preserve would I that'll has COVID schedule part increase not that of and B about picky question ask Raj, same sure of

Raj Malik

Yes, on one trilaciclib given XX on chemotherapy one, day -- every chemo the as infusion given day and in cycle has the a Tony. will trial, so Hi, day X-FU of days FOLFOXIRI. so the for is colorectal two with hour both two the given other be and

in recall, small-cell you a is the If that regimen. line, the studies regimen first carboplatin chemotherapy etoposide and three-day in in

regimen, multi-day where a trilaciclib chemotherapy chemotherapy. is with So, this given is

Tony Butler

Thank you.

Raj Malik

actually at is -- Yes. part the enthusiasm the second, where of And lot and is a the site initial are is study investigator there activation. site we the of

as ramp up soon. as and our So, enrolling well that a first rapid on in patient we expect

Operator

over time. Jack And will no at turn -- call I for are to further to now the this questions remarks. there CEO, or back Bailey closing

Jack Bailey

Thank and Certainly, Thank also free you to you the today. you, questions any look of out of forward I'll upcoming to And be us reach you well. feel to Evercore call. at may please for to with concludes Well, ISI the joining operator. virtual this have. many Stifel conferences. connecting the with stay us

Operator

disconnect. and day today's rest your Ladies you for call. conference may this Enjoy Thank and the participating. now of you concludes gentlemen,

G1 Therapeutics (GTHX) 4 Nov 202020 Q3 Earnings call transcript