GTHX - Earnings call transcript Q4 2019

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Operator

Good day ladies and gentlemen and welcome to the G1 Therapeutics Fourth Quarter and Full Year 2019 Financial Results. [Operator Instructions] As a reminder this conference call is being recorded. I would now like to turn the conference over to your host: Jeff Macdonald, Senior Director of Investor Relations. Please go ahead.

Jeff Macdonald

Thank you, operator. welcome XXXX GX Corporate and and Fourth everyone year Full Financial afternoon to Therapeutics the Quarter Good Update.

and Senior Joining Executive me President, and Officer; Chief Chief R&D; Vice Raj Malik, Officer. are; Chief Medical Mark Jen Moses, Velleca, Financial Officer

differ like I and actual on call today based remind you expectations. and from as uncertainties of Such cause statements materially may Before will would that to forward-looking risks include that results. we could results to begin judgment involve statements current this expected represent management's

Please our from the risk turn company. to for our filings refer the which with I'll concerning are the corporate call the over available factors information on affect now SEC that to could SEC Mark. or And website

Mark Velleca

On our Jen I we'll review conclude regulatory XXXX Thanks call comments Jeff. Good the achievements afternoon key priorities which everyone in I'll the and moving forward the call us. and will and today's clinical questions. highlight thank and for after financials. open XXXX joining on strategy in discuss you expected and our corporate additional milestones Raj, with for

key the milestones we XXXX. achieved with begin I'll in that

in we we cell for First, therapy trilaciclib trials for on lung myelopreservation lung cancer and cell breakthrough small data file randomized three cancer. designation compelling And an to are across MAA on-track based NDA received small an year. this

chemotherapy. trilaciclib in other with breast a trilaciclib significant showed well along as cancer findings overall evaluation our triple-negative in subtypes. Second breast in from benefit patients trial as data, receiving II Phase support TNBC survival cancer of These further

investing and profile Based the cancer. further potential particularly or receptor development for rintodestrant the over best-in-class a rintodestrant's our early could oral treatment are Third, that have of in HERX-negative on to-date formerly in estrogen tolerability rintodestrant advantages safety ER-positive believe We promising GXTXX, we findings breast setting. we announced preliminary SERD. as our adjuvant degrader data on competition selective

received drugs other that profile the positive a Coming lung to the small We lerociclib clear CDKX/X division support Stage pathway. our accomplishment of in II, trilaciclib showed feedback back a hematology cell regulatory significant from data our establishing filing. from on NDA myelopreservation inhibitor oral an from our randomized three was additional most the cancer Lastly data differentiated class. the trials XXXX FDA in

a quarter we the submission of began to We rolling in quarter fourth XXXX NDA year. the in of second this which complete expect

more ago As approved reviewed This we've program. reminder that advancement division which the with division is factors, of myelosuppression. a engaged the the heme the and the was last treating years since than the XX and erythropoietin significant growth beginning G-CSF trilaciclib in

of by to patient practice system already We been trilaciclib damaged prior growth believe current a bone marrow and function that rather to trilaciclib a the chemo. that attempt immune than can by valuable straightforward the during way rescue to chemotherapy. preserving in protects improve Administering care chemo, factors marrow marrow using has

submit a Authorities existing We've feedback application Europe data. we Medicines the XXXX. Agency plan fourth the data European in marketing had cancer National of the lung received authorization the supports filing cell to small discussions we U.S., with productive to that regarding Health quarter Similar and our to the in

regulatory evaluate we robust cancer. to breast are that executing cancer, small plan and development lung colorectal parallel for submission filings the in will In potential cell of a benefits trilaciclib's

as our the turn an to development as for like provide lerociclib. Raj? now update on to discuss call to over rintodestrant well I'd trilaciclib, Raj and plans to

Raj Malik

I'll trilaciclib. regulatory my I'm Mark. start on for Thanks to XXXX. going plans remarks development with our focus and

second submission our filing We have already rolling begun the small lung the quarter. to cancer cell for and on-track complete NDA are in

filing decide to accept to The for FDA the has review. whether days XX

in marketing authorization Europe. providing including we We've PDUFA working data for and submission been the quarter update date. that is Health confirms interactions MAA on or co-rapporteur. have rapporteur anticipate Concurrently, file our sufficient So we're to several a Authorities, a package the an third had and with a National we MAA status who in application assigned

content and MAA overlap in NDA we There and for between file required quarter the MAA to the the expect the the XXXX. of is significant fourth

are opportunity make to this benefits with lung We initiating trilaciclib patients time, chemotherapy with tumors At small available of an additional the to and excited cell other additional to have potential and trials cancer. are same regimens. trilaciclib the year to we evaluate

a colorectal year, help than represents III outcome treated treated with fourth the primary trial This the there each which X-FU of Phase cases with opportunity chemotherapy is majority measure. plan XXX,XXX chemotherapy of as to We in Globally, quarter of XXXX X-FU to with patients. in the based cancer initiate colorectal more based. significant myelopreservation a patients with are cancer

Much variety data treatment on generated GI preclinical of X-FU multi-day used trilaciclib treat a of this was our that to a and using regimen results in myelosuppression. is severe tumors

and evaluated a chemotherapy trial. long-standing be breast I-SPY will with and was cancer cancer neoadjuvant standard successful breast trilaciclib, locally-advanced ER-positive addition treatment for with In a or disease without inhibitor. including X Trilaciclib checkpoint into combination in the of regimen HERX-positive accepted triple-negative PD-X

an trial endpoint which assess complete myelopreservation survival adverse response event rate the primary event-free with is has triple-negative We'll in to correlate disease. pathological also effects. data The been of shown obtain to

from trials data to early XXXX. in both and the two expect late I-SPY colorectal We XXXX

At demonstrating Congress, with in profile activity from the pretreated data preliminary of evidence reported best-in-class ESMO patient and we potential escalation rintodestrant. a Moving tolerability a heavily dose I/IIa anti-tumor to Phase safety population. our XXXX trial

being data from these expansion cohorts milligrams. quarter We fully we cohorts Data the the escalation dose dosing anticipate and dose all fourth and XX the this reporting are In of fourth go-forward additional quarter study evaluating establish enrolled preliminary dose. cohorts both XXXX, patients our in at year. used to from XXX X,XXX

to or are the and palbociclib additional evaluate We inhibitor of trial the of an combination this initiating CDKX/X arm Ibrance. rintodestrant

to patients the second this enrolling this quarter begin expect year. We with in combination of

and cancer lerociclib non-small completing breast our cell cancer previously disclosed, lung As trials. we are

data safety cancer differentiated is and data that of showed CDKX/X in Our report from third with quarter efficacy year. trial tolerability inhibitors to and HERX-negative profile. the We other efficacy a breast comparable ER-positive updated in with promising fulvestrant combination this safety plan

trial Data Tagrisso lung non-small in showed was combination from tolerated. well cell the with cancer that our

robust the the to efficacy effect evaluate of the trilaciclib not regimen. plan trials antitumor lerociclib patients in ourselves resources We data believe therapy benefit and combination initiate potential and a of not to on We monotherapy, treatment lerociclib enough the to focusing types. the rintodestrant. additional are are on Tagrisso across cancer mature Given that do combination range of has

Jen Jen? now the of a to financials. the for review I'll call turn over

Jen Moses

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

million XXXX expenses for million of million XXXX. loss compared to of net $XX.X XXXX fourth of $XX.X fourth quarter year. the $XXX.X Operating year a Net for the were the $XX.X million compared was to loss for prior full for the quarter

year. compared Operating GAAP the million $X.X operating to $X.X million stock-based year of prior XXXX $XXX in million expenses compared of include were quarter quarter full compensation expense for XXXX for million $XX.X the the expenses XXXX. fourth for fourth of to the

XXXX and for compared year compared XXXX fourth fourth for million the development quarter Stock-based for of $XX.X XXXX. million quarter compensation to $XX.X were the million was year. for expenses the $XX.X of $XX.X expense million full Research the to prior

in million for program to to due was expenses pharmaceutical expenses personnel costs, due year R&D were year. $XX.X primarily $XX and full costs clinical compared headcount. million the increase increase an prior XXXX The to for the for active costs manufacturing additional in R&D ingredients

General to in for operations. XXXX in $X and to increase $XX to costs support for the the year. increase was increase headcount $XX.X full XXXX. year necessary in for of G&A were increase administrative million activities, affairs our other compared the pre-commercialization million compared due expenses quarter due in and million quarter million The medical the fourth XXXX an additional increase to in an administrative G&A costs professional of and largely fees expenses $XX.X expenses compensation, fourth for were prior to

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

this will the sufficient second be of fund to operations cash into XXXX. our expect half that We

in the to million we $XXX release, are million cash with $XXX guidance year the As end providing cash press noted to equivalents. XXXX and and in expect

realize prepare primarily for launch other We consideration XXXX, a expect guidance our in European and that activities, commercial compared cash filings required does burn collaboration partnerships, will and increase due include regulatory to successful this U.S. complete we sources proceeds trilaciclib not capital for of from or U.S. This XXXX. of the in to may year to investments

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

Mark Velleca

patient that shareholders. XXXX productive opportunities to very for value care and a Thanks, for create XXXX therapies Jen. In improve company advance summary, created in has our can

small better and chemotherapy cancer lung Our top tumor priorities that trilaciclib the regimens. and are types getting trilaciclib patients with cell treatment other need evaluation additional in continued of options to

patients, recognized Our make patients Clinical valued time has will stakeholders, will vision safer, are potential that to these improve providers types shown and some chemotherapy receive and health trilaciclib our we broad and patient and live that of market experience time Based believe tumor for that longer. they be the is settings help data relevant chemotherapy. payers. interactions the in care across highly outcomes with trila on solid with research have by trilaciclib a benefits the and range patients every first and treated patient-reported

to is this value retain cancer. opportunity continue lung cell in potential Treatment and breakthrough provide cancer. Therefore, community positioned providers the to well value we trilaciclib's colorectal lung efficiently breast and effectively of first unique of patients therapy. XX,XXX the large unlock the concentrated in about launch cancer the small small commercial benefits of GX rights, in can to is in is approximately in the the of education practices. with but trilaciclib oncology U.S. demonstrate we cell and U.S. Our to full this patient

course We about our over will to plans XXXX. have U.S. much the the of in launch more say

potential the plan continue partners ex-U.S. discussions infrastructure as do out will We we build with not outside to U.S.

best-in-class believe has oral advance development. with rintodestrant in milestones, among development additional of potential to use its combination and We clinical palbociclib. the through rintodestrant. including We to plan rintodestrant SERD Turning evaluation

most the and we benefit resources returns. where can achieve significant we is patients which making the in investments are trilaciclib rintodestrant, timely where of believe We most and investment can

Lerociclib are on while has differentiated focus profile clinical we trila is further enable that exploring from CDKX/X inhibitors and will other partnerships rinto. shown that a we development and

to We XXXX position financial these a in investments. entered strong make

operation We the cash explore fund company. of opportunities half to have to second to continue XXXX non-dilutive sufficient and we into further the capitalize

which experience trilaciclib is potential Trilaciclib the therapy patients. acutely are the opportunity first to bring need significantly needed by FDA about through only improve to the to to of better excited a consequences that and solution chemo with breakthrough the trilaciclib near-term of pending for and is the do the patients physicians they We review long. particularly therapy these far patients who been myelosuppression. suffered believe We and immediate have that lacking too and for offers We long-term this patients.

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

Operator

from from Your [Operator your the question. Please first James. Dane Instructions] of ask question Raymond comes Leone line

Dane Leone

Hi, of a couple a thank on great XXXX you. had update and productive XXXX. Congrats a on questions. very I just

then The extent it it just as first out? Or into to study? that. more few does Pfizer got of bit Is just you what following And kind this more could additional studies clinical be color a studies advanced supply provide a for the play well? or would agreement have to you little with when that I just one, and

Mark Velleca

Yes the current about for study supply which as agreement is disclosed we is patients. previously current the XX

Dane Leone

there study? And advanced a discuss plans into any anything to I is built there that guess Or Or step-by-step Okay. that further into process? extend is just it more to that? is a

Mark Velleca

for Yes a now agreement. supply step-by-step process nonexclusive

Dane Leone

Okay great.

Are of inhibitor kind looking be partnerships of where creative lerociclib could development of for traditional the to team? sense sense? a CDKX/X partnerships makes terms to area? the Or in in for make CDKX/X more more In looking your you what are areas you other

Mark Velleca

a acknowledging that We're traditional types. space looking breast both. could cancer kind and in play but certainly think tumor other role X/X I also i.e. the of ex-U.S. Yes X/X

say fair both. it's exploring to we're think I So

Dane Leone

alluding Okay. talked trilaciclib. here partnerships about explore rights with be And like on U.S. you then to partnership in you a just ex-U.S. Late last would that and to finally program retain year the and had seems that it full

XXXX quarter your Given fourth are or partnership the that still with changed? in a file during you you for trilaciclib when EMA file guiding to has planning on or

Mark Velleca

So partnership ex-U.S. we do have opportunities time to explore

quarter. you to XX-month on the MAA we As are alluded file going the in approval. There's fourth an clock

that's deal make the of right So we best sure shareholders. do interest have we're time in doing the to

Dane Leone

much. very you Thank Okay.

Operator

question next from the JPMorgan. of from comes Your line Anupam Rama

Tessa Romero

for Tessa our are well for thanks question. Hi, Hope the and guys. the guys today you and on This is updates call taking Anupam.

then education in the initiatives what me currently ongoing? how scope Just of size little one activities that of but you here the much. Mark a initial thinking for U.S.? but bit you needed the this on is you remind alluded an are for the us can trilaciclib and are the U.S. your about just And so sort kind sales of launch Thanks force pre-commercial on in to perhaps

Mark Velleca

Thanks lung Sure. oncologists trilaciclib. of in and question. but Yes patients for the myelosuppression the providers impact that the not small-cell trilaciclib, important Tessa pharmacists their understand practice is very can has education just novelty nurses that practice as on for administrators, cancer so

see nurses and these Many especially in you lung at a of field in small-cell the a sites these medical our and have providers them and enrolled large cancer, patients the lung force where southwest. again science We southeast well. lot and cancer We liaison small-cell oncologists know very centers others these studies. three educating of both of

than So people. this we believe own is a that's sales less do XX on we with our can list a force that

Tessa Romero

much so questions. Thanks for Great. taking my

Operator

Cowen. comes line Your of question Chris the Shibutani from next from

is Your now open. line

Chris Shibutani

happen Thank opportunities need and discussions and the terms talked others you've trial you've much. in contemplating? of going label With Good you Can to by colon you considered be you'll order the accumulated sort what the to in how trila colon that to had particularly in expand of about to continue that to needs indications of size? additional Thanks points afternoon. And terms work. we're confirm for you have to particular you to like further sufficient in assure instance continue FDA be data in – exactly colon about like expand indications what other very you're questions. that additional doing for for to thinking

Mark Velleca

I'll Chris. Thanks that question. take Yes. Raj let Raj?

Raj Malik

you FDA we approval plans as country protocol design meet including to authorities all as study size Yes. cancer agreement the with the for have the said Hi, parameters. the to European on critical Chris. colorectal as discuss so and gain Yes, and endpoints well in

all year. study So start this we be before agreed that the later to will

Chris Shibutani

where And data I it. talk initial Got to follow then some the of being 'XX. rinto you up preliminary quarter believe have to on on able about fourth

at of combination rinto clear with that include be will any to Just data point? in palbo that

Raj Malik

be cohort which cohort. is be data the presented, that escalation really dose we additional will It No. well previously -- it the as a will on as expansion

of So in total, study. approximately XX patients worth of data from that the portion

Chris Shibutani

Great. Thank you very much.

Operator

of your comes Your next Shrader from the Please line BTIG. question from question. Tom ask

Tom Shrader

taking Good on a kind morning. of Thanks remedial I-SPY. for question the question. I've

three work cohorts like they types and Does mixed have Are cohorts treatment of it then sounds an real of And you be data size considered question way? cancer cancer, most still end all get to So it enough package? arms. breast accelerated four could that for any to is what's some the consider the the at graduate? in line this you And is it combination trial? -- treatment different

Mark Velleca

Raj?

Rajesh Malik

yes. Tom,

is bringing the set backbone novel of with way of in is, trial as as ER-positive, into And the setting. patients its can the a agents enrolled efficacy that improve are platform up So HERX-positive the goal chemotherapy. well I-SPY triple-negative the

In of that addition, are there part other are stratification. biomarkers some that

there surgery have continuously is -- This arm within pathological is the data was is about specimen. patients as so made complete an response and and design as adaptive evaluation an chemotherapy, respected evaluated each the complete then whether

is succeed in type then the is and this it a a XX% comparison Then the graduation predictive adaptive of experimental a probability since that arm of design the or to the if in arm is that, I-SPY what probability there that predictive endpoint that CREs, that results control same would a and arm III, higher Phase graduates. is stated arm against has as probability

KEYTRUDA which neoadjuvant which forward study. So in that's Merck positive the into the what happened in KEYNOTE-XXX for with resulted example a study took in setting then TNBC,

-- where It of of assessing the II way good success. III focus very Phase Phase a study. is probability a a highest really it's the So with to

for So these registration. be data will not sufficient

Tom Shrader

probability? But effect. size so of treatment and a cohort graduation It's is a blend

Rajesh Malik

it seen. are and the they're portion is, arms if don't enough design. patients the down that those Correct. where to activity works And that's our Correct. way activity, are there shut is adaptive of internal have enrolled And arms certain

Tom Shrader

All very right. Great. much. Thank you

Operator

Needham question from Please Chad next from Co. your Your of comes Messer question. & the line ask

Chad Messer

evening Great. Thanks. congratulations Good a and let on add me great my XXXX.

to the just what rinto, of discuss we studies, you of general? always be. we've combination Can wanted for as where for -- is I For get mean, think oral now bar sort efficacy is kind SERD there you in into which

Mark Velleca

In combination, the the combination oral can to with is an with in adjuvant now Mark from we reasonable we our a And real a I equivalent doing SERD Chad, in because was take you here. fulvestrant PALOMA-X sufficient to benefit bar. study that believe since as view setting. efficacy palbociclib think fulvestrant. its is is are That patients with

tolerability, good to is setting that's equivalent fulvestrant. with therefore, as efficacy good in So adjuvant well, the critical, safety

So these I a we're fulvestrant for this that is enrolling think -- palbociclib. with patients benchmark reasonable XX

Chad Messer

small little maybe the heme and/or tox then can of you there Okay. talked part that the rationale there and trila, being differences colorectal. through cell? -- two just a I a And are Are X-FU it for of X-FU and having you know kind data compare tox? lot about contrast the profile regimens bit the of a heme for different go between with of similarities with Right. But in platinum preclinical big

Rajesh Malik

Yes.

oxaliplatin X-FU using irinotecan. is the regimen actually that we'll So between be and combination a and

cell in is the first lung IDV FOLFOXIRI. i.e. And more the toxic. this etoposide/carboplatin line. say, a cancer and Topotecan it's it of second/third-line much regimen myelotoxicity regimen type called the would small is, would I topotecan I toxicity, regimen of combination the first-line So to equate

Chad Messer

All Thank Great. you. Right.

Operator

this turn further at are There Instructions] his back for to remarks. over questions I will no time. the [Operator closing Mark call Dr. now Velleca

Mark Velleca

you. to any reach questions. operator. the Thank with us Please That call. concludes out

we for the a joining Barclays us conferences in be seeing you the weeks. Thanks coming and at James meetings. at many of good forward will reminder, and to We have As look Cowen, Raymond a evening. those

Operator

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

disconnect. all may You

G1 Therapeutics (GTHX) 26 Feb 202019 Q4 Earnings call transcript