TGTX - Earnings call transcript Q1 2019

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Operator

Greetings and welcome to the TG Therapeutics First Quarter 2019 Financial Results and Business Update Conference Call. At this time, all participants will be in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is not my pleasure to introduce your host, Jenna Bosco. ahead. go Please

Jenna Bosco

Corporate morning TG Good business to conference today. President our I'm to welcome Thank conference our first and quarter regarding call of Vice Senior Therapeutics Bosco, and and XXXX call I Jenna you you. TG's welcome Communications, financial update. results

and will well Following company's over who our on of Financial and financial ongoing high Chief will Officer, our then, Sean Executive to a provide and update turn Executive Chief provide ublituximab the programs overview development an compounds Harbor TG's overall lead and statements, level call company's our stage of Michael results as our the Weiss, brief early Chairman umbralisib, Safe the Power, standing. as Officer overview of a

participants be be filings. for include recorded to those TG listen-only mode. in operations that to this the that available XX that rebroadcast indicated. on constitute will various uncertainties on would under harbor remarks statements and expectations, audio All Before actual that various for we our This call where SEC that these risks of I prospects the may results found can are plans Securities will XXXX. risk the www.tgtherapeutics.com, may make Reform and differ forward-looking Therapeutics subject our we purposes safe begin, remind it to for conference call factors being everyone our Act be about affect cause of future on Litigation TG Factors provisions cautions Private statements like from forward-looking materially that is days. website, a TG's next

overall for to financial conditions. turn our to Power, to Financial first the as of like would XXXX, results quarter briefly company's Chief as Sean well discuss I call financial Officer, the over the the Now,

Sean Power

Jenna for and thanks joining you, everyone us. Thank

at www.tgtherapeutics.com. section earlier were website I'll and on viewed our cash be & As Investors Media results you financial with our of this position. the may released morning aware, our be can begin

positioned financing quarter, securities our with were sheet, a XX. us complete debt on ATM remain as facility additional to net to of leaving of to position as the strengthen able XX, investment utilized we offering and equivalents that of for us forma XXXX million ensure $XX.X the million. execute During March balance goals, we of approximately and our to quarter-end, a cash leading subsequent we To to cash, cash sales public equity proceeds well $XX.X -- March million of our $XXX.X pro raise

quarter ATM the issued campaign and million. our were during Inclusive we shares believe and the $X capacity be third to runway through our would through second position average mid-XXXX. our the price sufficient venture potential $X.XX was facility additional during XXXX. quarters, under cash total our Further, current this approximately of cash will Our capital raise first operations fund extend borrowing debt of

or XXXX. loss million, share, quarter net or first the net approximately during quarter million, of non-cash $X.XX GAAP quarter million, XXXX, the excluding compared was for $X.XX for loss per loss of while comparable Our our first $XX.X share, the per a net to $XX.X in was items, $XX.X

major of into we've number oncology a versus in a contributing begin would we've decrease XXXX, directed registration some the trials net R&D and As been which to decrease in as begun that, to is in saying of loss factor now quarters, MS period for our realize to our comparable spend both XXXX. progressed and a

With will call Chairman quarters. -- this that, will the and this trend Mike the several turn CEO. over expected over to next Executive now I Weiss, that We continue our

Michael Weiss

year. the morning. for TG I everyone us can in we're about super course. this thank of all thus joining And Great. all at saying, far speak excited Thanks, Sean. And I thanks, this know Jenna, you for developments

top many on Marginal of designation. the been and and Zone orphan the of achieving Lymphoma program, breakthrough the with drug positive receipt designation top made including results key the release our course, list, significant With line of progress has the milestones, of

the with on by of combinations Phase January, achievements from clarity of final layers B-cell clinical notable data XXXX. translating In month, the designation January, and significant positive Lancet further MZL. believe ublituximab, the further of treatment focus year-end, bispecific for first-in-human trial combination label the from just that study meeting, of equity annual call had breakthrough Zone year in $XX off robust data announced trial X value drug MZL. orphan we other the from in by with the Xb of median UNITY-NHL umbralisib well MZL the treatment fertility the tolerated bringing most multiple or of MD modification potential the we of Lymphoma to from of our Zone and And up quarter. of publication umbralisib Nathan in where relapsed no believe announced highlighting come open the the week, the we that Phase we label opened Dr. In And highlighting interim reviews thus and AACR we far the we toward we the requiring of a long-term were financings. filing, We for the news demonstrating the trial the remains of issues million we to safety antibody a of by or announcing debt study therapy trials presentation therapy shareholders. start analysis. month of February, the ibrutinib PFS potential in noted, after, this UNITY-NHL data that, the our both Cancer pivotal investors, X shareholders. approvals with DSMB our April presentation launched received has potential at for no the with into given value Marginal received outcome study to X ublituximab the hopefully, to with plus MZL announced important into Also cleared our within UNITY-CLL oral the B-cell along FDA lymphoma. in a Sean additional following XX.X some from Lymphoma, or ublituximab Cohort Fowler NDA duration positive UNITY-CLL Phase patients patients of umbralisib with data reported that from later by end discontinuing March our follow-up sclerosis, umbralisib, triple relapsed patients plus in Anderson successfully the Haematology. of that CDXX/CDXX then of a safety The open pipeline positive And for forward, secured due the Phase event. refractory will for FDA which reporting Shortly unlock TG-XXXX, of B-cell from are of occurs, follow-up as from trial. and extension and With patients Marginal the extension let's value refractory kicked significant we in the and monotherapy for UNITY-NHL We Moving the also designation once an cancers adverse Center we approximately weeks,

by stage. with IRC. is the overall or response single Marginal the highlights Zone quickly Again, Lymphoma an taken The includes endpoint Now, confirmed and with Independent center Committee rate ongoing for MZL start agent as treated let's some trials. provide patients Review UNITY-NHL where Cohort XX the single-arm umbralisib, pivotal study primary from study, let has me this

population as already treated important been for this quarter. rate target mentioned, again, the As of is met of with study's response the response primary developments internal a program as XX% our overall I XX%. overall had first well entire the significant to of patients the there few the which And endpoint during most very that XX

to accelerated goal filing. be all would with FDA to be -- well, for approval our year-end. the goes Next discuss step for a us is potential file accelerated If meet by approval to to

for talking about study PFS this no have no study said, if concerns. predicting and somewhat year this our push remain is line XX% original before our worth noted Next, is that passed out reviewed were successful certain provide treatment there PFS requiring if this or XXXX. It's several complete as relapsed line forms trial, in same call progression-free our control due now. UX, take precisely that The umbralisib me PFS. complete quarters prospects of events UNITY-CLL portion This approved survival, first recently longer approximate issues a ublituximab and with primary in both I can Leukemia progressed part patients plus read a endpoint. arm randomized patients from above, estimate using end this a of of in of trial recent determined and the are before analyze number result. is patients we've arm. Lymphocytic the expected, endpoint for and into some XX% with which the study trial. patients are we than can improvement which deltas study an challenging, large been The met see in in trial the current again will safety with and to from Meaning, of to that's study of PIXK studies course, study control PFS of makes extremely assumptions naive in who CLL, DSMB, there and Otherwise, the safety or are is let or safety CLL. other refractory power CLL this when to That naive noting modification which event-driven that Chronic for the could realized, optimistic away We highlights significant need and treatment this we the a about

successful DSMB study. a the recently interim we earlier, and mentioned As continue PFS analysis that conducted this futility recommended

for those very are alternative continue to or who a important issues candidates to therapies, attractive providing is BTK-based for believe good especially who UX with otherwise patients tolerability have in an on therapy. option CLL, BTK not treatment patients We

from trial, which show Phase of Next, not program, now weeks. AAN, we the the investors. Last I'd or data highlight at which fully to tolerated extension appreciated label is of continues to some follow-up aspects ublituximab that our OLE MS presented week XX.X to meeting the by open X is of with continue like believe we well

highly ublituximab that a Phase highlights and ultimate XXX% and available rate believe and efficacy, Phase in the results X ongoing that includes reduction price annualized our We program are profile Additional therapies. X.XX included better X to Phase best-in-class final convenience of supportive comparable over MS believe safety, gad-enhancing the a deliver data can comparable from I relapse X of lesions.

there one relapse ublituximab of endpoint the of known RMS. comparing As a as and quick with subjects Both worth some for trials ubli The was great mid XXXX. we primary in two of data MS study we treatment. in is annualized rate also X great control have each following and forms XX had at trials KOL proposition. It's ultimate Phase to meetings value expect that relapsing MS enrollment, in active and its interest in weeks an AAN, are and reminder, teriflunomide completed noting

our in be to represents for MS significant CDXX It's our revenue large anticipated the drug of to addition Clearly, value we to for of enthusiasm we an our layer pipeline, can return access shareholders, licensed with ubli the ofatumumab, MS can in to full earlier would have continue in in city closer like turn with the novel to generate year share potential to advance can impressed believe more I'll and that into I'd currently result exciting to in $X and and our that noting included even we this clinical closer over novel for begin the it its a mentioned have year of to antibody, second BTK progresses in build approved infusion concluding possible pivotal to robust currently TG-XXXX, compound, anti-PD-LX Q&A only bispecific one-hour early these the or most as a adding in And potential to We our that us trials -- billion TG-XXXX, -- populations these shareholders. small of plan patients candidates drive provide growth launch. this With to portfolio value which market that, more with we finally, UX continue and and compounds in as XX one XXXX. of cancers, including for only data, call curing a and very patients. our strategically remarks. TG-XXXX, about conference -- is and another some goal operator to and and session, combination approximately the market enhance the price is pivotal inhibitor certain to compounds XXXX anti-CDXX/CDXX believe We of antibody. worth portion of B-cell recently our our early following

Operator

Cantor Thank [Operator from Alethia now from session. coming is Fitzgerald. conducting be you. first a Young Our today question-and-answer We'll Instructions] question

Your now line live. is

Alethia Young

progress quarter. questions. taking on Hey, over the guys. Thanks Congrats my for the

timelines. NHL you've the you're data the how I the Now, data, was on needed. maybe study, just around arms? that discuss how what obviously on And sure out you just On follicular clear wanted MZL I have curious, then, I be MZL the FDA. know probabilities just about guys that, can but you thinking about are the may have you reading with follow-up published to potential much I guess also on I'm think know the the make the conversation how

little sure scenarios in you're hear working I'm So, that? just to more your some so want a through Thanks. head, bit about

Michael Weiss

Sure.

margins work with the backwards we'll and So follicular. I'll start

it's us have patients. will year-end. believe we more follow-up of what follow-up, to we significantly feeling a asks So nine a now, all and nine XX filing down that. them. hard going of months or a Even still to than in median for follow-up But follow-up follow-up believe they're if again, can each the months good patient we right of by exactly FDA But is on us in for know gives until of sit have the I terms XX with look needed, we our

think I follow-up be which reasonably of to XX was depending XX on Zone. both the to the Marginal two a with would of consistent it months when ibrutinib approved timelines, it's

in we're the So range.

to alternatives aware get of -- skies see. timelines there. my are, relatively we will that conversation. obviously, I want do, we I until but what Again, have people over the think don't it's in we're out we'll And once we'll make but tight, the terms from of

I to So important think that's that get us clarity. for an step next

follicular the since a of guiding terms the we to Zone. as were Marginal we've In arms, lot been folks, saying of

turn is ready right resources required to We’ll ready potential workload that finished not CLL attention Zone and focusing we database. We’re getting we’ll turn attention Again, clean our to on depends the once our CLL Again, presentation the how follow-up that required. all of those. to that cleaning on filing. also and data and data filing. to get the getting that on either add is in, available, Marginal for really cleaning now team's cleaned and the data also much work for filing that, we’ll if Having follicular the and follicular

terms end is this of follicular best our into or So filing a top-line with at of that follicular guess of point is the year closer to potential in middle XXXX the for year. next

Alethia Young

label good now like lines How you a CLL, I split a third from of confidence naïve. being some get evolve -- Just of line with of like this, maybe my on versus to kind you able the got your in earlier second level do between XX/XX there? and what's kind

Sean Power

Yeah.

the for both So patients. in relapsed/refractory. is designed this patients first study there's treatment naïve XX% and line of Again, are

get I expectation full our and are -- both relapsed/refractory. where -- that see expect we cover line, don't instead successful, the and we patients if which be to the are the we think it naïve second I again enough study majority Yeah, treatment think is the scenario broad line not the because I line. we is do will label of get the So would first a first be. we

internal where carried only so again, a to we the entire trial. that versus front imagine about rather expect -- relapsed/refractory or about But the both only then if directionally groups. same question be one two relapsed/refractory, were groups get there is line that is the positive the if the it consistency almost would or don't caveat We that not it thinking The -- of the is know group. to we potentially have of impossible situation

that potentially even we so carries relapsed/refractory. -- which to only more the that split, the get need contribute groups receive the and likely relapsed/refractory really It's successful have almost doesn't front-line of And because there. the again thus, both to outcome. is a But

both will positive are significantly the just have -- where the to not be both better group counterpart on side I Again, outcome. the scenario to things. is So be each But they doesn't ultimate of that don't its than groups don't a successful expectation envision contributing group. -- statistically I

Alethia Young

Thanks. Okay, great.

Sean Power

Thank you.

Operator

Thank you.

coming Our from James. today question Ren is from Benjamin Raymond next

line is Your now live.

Ren Benjamin

Thanks therapy, timeline. on Hey. your the patients Mike, have as a many long DSMB because responding the on think PFS they're regarding taken Good about they for bit the questions. sense have met, a guess, sort and remain therapy can place of can confidence way mentioned you time guys. you taking And control you I the to remain morning, for as sense you but trial experimental versus every little of how do do the the talk meet, I the events many get a they the how combination design arm? is of as

Michael Weiss

Yeah.

benefit tolerability therapy are they're are gaining So have and patients issues. benefit continuing to stay will long as as on having and not

sort first-line XX trial saw and a which which in good months, So the just relapsed/refractory you've yeah, relapse to course the vast of the long trial. then, the of will and not The for takes is PFS the of a as majority, But And we we line control them from arm we how XX ballpark. measure. from relapsed/refractory to CLL at patients arm therapy expected control relapse. XX months, of it's it in is anywhere is and the patients half in XX for getting described be six-month patients ILLUMINATE to point to what see saw in cut expectation the a are median front you to for almost some course, can,

-- it's and the -- going yeah, dramatically enough think thing, predicting relatively the is well-known to this control is shift we so end terms is unlikely. the mean, believe that I -- of in that believe belief that it's our So we probability arm again, this I of

ILLUMINATE So CLL months numbers line what relapsed XX again, XX if is front you'd got assume months patients. half approximately those of patients. to of see you've a between and two in Again, in to bracket XX, you expect

You've I It good sensitive think of out. XX of got when modeled relatively a pretty from very changes total We've PFS range well -- there those kinds to modeled not and a months within we've you're doesn't it's to XX out. PFS. fixed that

By pretty months follow-up year, point will getting Our end have is XX, this median this we at XX almost an better. of follow-up. and good the of

of potential it's in to follow-up, of group their right. about think that, XX hasn't basis XX blended that reached you if hard median XX again, months a PFS months entire at for that So on imagine to population

So assuming only fact that of variable our described powerful performs about if to have we arm. survival, in times XX% XX% whether performing our described with study is in said numbers performance improvement benefit The right, their over in we've well to and few improvement in then group fixed. is XX% potential arm XXXX. that, year. the into control then over over line than fixed terms a the control the the of we've is a better If end XX% PFS, study, assuming as progression-free is the XX% arm by control relatively as to as the the is XX% should this a better-than-expected, improvement, will having go be arm Again it

Ren Benjamin

progressing. confirm you DSMB don't based an on it's of Got though how want meets every you that it. idea I It's have still the of, have, sort just model. advances updated as that time to

blinded You're results trial far? completely so the to

Michael Weiss

to trial blinded completely results. the We are

Ren Benjamin

it. Got

I'm might talk then, just with are. guess landscape most you're you approval use importantly, questions and just that your up continues regarding approval for seeing. can I and that in the MZL to chances we seeing setting? application potential rituximab impact approval, landscape shift, sure, the following as the Just how you're commercial How or about we lenalidomide timelines get

Michael Weiss

Yeah.

it as A Marginal of terms look in tell. we doesn't far like lot. – as is changing can lot So a Zone, in

good So path we do feel pretty like approval. we a to have forward

it's to patients options good drug. application, Marginal in of Marginal for very think many Zone, a the – I we than drug terms we've CLL not chosen on patients profile We the with umbralisib, there's tolerated. is everybody. Zone Marginal attractive profile for profile that in a treatment a drug is continue, for situations, patients we've it it's thus In far would at better non-chemotherapy XX would Obviously, opportunity we but think with a in good it that of Lymphoma, a Marginal commercial seen small it's we need Lymphoma. perfectly described think overall for in and think not very good that Zone we've non-chemotherapy it's AACR Ibrutinib I have molecule is the look if the we patients that overall, with presented as that Zone in It's but argue first – that Lymphoma. a more were the be

least We importantly, response to of have a onset to rates on the in surface – the -- the it rate. more complete time differences a appears at higher response. are and But be response median

So have time if and through a up about has between times you median you're a months patient to you so response and of sooner. months, and again, response the assuming the two X.X patient you're if options, median get one X.X know has data one analysis, about the to a final holds choice

reaction complete a If to of good probability getting you're getting a response the drugging, rate. higher you a have

comparison they but profile. it's we've -- Obviously, each an head-to-head think attractive against it. we got because other, yeah were not a and we it's So, think studied never

have think we nice a to drug, talk our just and it's We about Zone for attractive will label and patients. Marginal

Ren Benjamin

the likely DLBCL choice. make is do to delayed not the the timeline? a waiting Company's It's cohort that's think And guys And expect responsibility, this sure and I later FL you your in the that just study. similar to question the DLBCL want right. we Is I The decision the two final year, trigger. when cohort like I we're UNITY-NHL expected Got the un-blinded middle in thought The that one read-outs or just year. pull with I of decision and we for think thing FL make mentioned you me, had And events cohort. the is that it. the be to for same

Michael Weiss

at at about months given diffuse almost de-prioritized for Yeah. B-Cell been market. the nine large has Diffuse in been now. a year unknowns I'd B-Cell least has the least large say our feeling

So excited data resources there we Unfortunately, there's some to a lot analyze kind in of point to don't but just dig maturing, terms and dig the to in today. that it. have is resources that corporate data, of into

So at will us. point, will closer see CLL. some follicular of to have CLL, and we if If again, as diffuse end on the toward focus we'll get we then what in year, of the CLL, to focus B-Cell. have front be all Again, the we we don't large have turn

Ren Benjamin

Great. taking Thanks very much question. for the

Michael Weiss

Yeah.

Operator

Thanks.

coming today question from next Our is Wainwright. White from Ed H.C.

Your line is now live.

Ed White

for morning. Good taking Thanks my call.

had you XXXX Mike, and XXXX. that XXXX, mentioned So –

to the more we timelines little XXXX data a of on those on could get just And information expect see wanted go. When can to from I bit XXXX. pivotal -- just those if have we as also that of BTKs, more move we One of each to then trials? as a XXXX. far in can see

happening wondering was that's on I We in development you see waiting XXXXs. the for haven't -- Thanks. spoke what's about that to that's just if sidelines with if or

Michael Weiss

Sure.

easy aggressively a So very on at pretty to point. I -- XXXX well think Right we're the with don't think XXXXs now, I question going things XXXX. compound is are backup was this XXXX moving

we've stands is first it dose today along and trials look, started large we're the from along, furthest in probably XXXX, because as each In and it potential got I seen so sometime activity trials moving pivotal these terms part, think, the level. for of at first the data in BTK of

makes it lot So, a it easier.

the also the with around both UX. just we're optimal a Now, trying to in identify combination dose what agent as margins and is single

identify this us we during a into we'll agent pivotal a a program BTK, and remainder single hope which So be year, start both trials could take I the would position that pivotal that in from would XXXX in compound. sometime ideally UX able XXXX for of with dose with combination put to to that in

Beyond TG-XXXX that, or the PD-LX.

that both is really from ability active. The and really engage of conducted highly a solid looks its checkpoint in great. by We confirmation neat tumor have T-cells some profile the compound drug It's K-cells. studies the to terms good

only AG of class challenge has So, a dual that in has also it short compound Merck also that the a really that it's has drug -- has The its in that Pfizer, antibody bit capacity, capacity. half-life. that but

So, has domain, gives its compound it have full to the ADCC. the of which ability a two-plus it week, of this maintenance half-life plus FC

it's Again So, gives been us really confidence whether unique solid makes say, and I which to active created, with it an far, a what interesting just ever presented, high the we're it's best a that's unique obviously very recently it's that PD-LX think the seen very PD-LX. that's but trying tumor data we've PD-LX that not so is level that dealing and an agent. we're

on also then, our every novel study. with second us really We're half getting We're two is that it's starting just If heme going the we're we're into they milligrams the going So, studies data not dose solid first-in-class right second the going -- at-dose that is now. XXX half. is left XXXX, agent. out the in CD-XX, on. get everything going half, a the tumor weeks. at bispecific studies well, to in if But of late question. CD-XX so, May, the be in. the of pivotal toward each months population of in and obviously, XXXX that the bigger to have We is But understand And think may If certainly second wildcard what's we're to very from good one get going should a to now. -- and on it's pretty I six eight again, patients

to very in We escalation, dose the have start low so that's ongoing.

of combination what be there, as timeline in but So, that going obviously, the me with to it's will soon early to we I for can. super as portfolio get think our assess too the excited rest

Ed White

you. great, Okay, Mike. Thank

Michael Weiss

Yes. Thanks, Ed.

Operator

you. Thank

Our Humphrey. Pete Robinson SunTrust next today is Lawson from question coming from

Your live. line is now

Pete Lawson

Thanks the Yes. for questions. taking

physician remind still feedback XXXX you on us and like timeline, what's potentially the say MS, can is been that just the Just on AAN a product?

Michael Weiss

Yes.

KOLs, So, -- with back-to-back in terms was meeting. we it also we very the day is AAN. of multiple the product portion heard meetings great spent of pretty community-based a much think we had We KOLs. meetings full excitement at with what enlightening The physician better really was for feedback, And high.

I think there's enthusiasm.

the infusion, it's big The but one cannot quickly just of convenience at deal. folks possible think underestimated. as a freeing and infusion the be might I be up think economic the that of as a a factor. effect suite surprised attractiveness one-hour patient not chair It's only

great MS. of of yes, we've the in we excitement our So, a enthusiasm got again for just were -- profile lot reaffirms and and feedback, ublituximab

we should yes, timelines, the start see mid-XXXX. studies of terms in should – studies In the from to data

filing If have in. would of be is or ublituximab in expectation so is for all early in with try in Our BLA. to this goes BLA. a XXXX get CLL, XXXX before end a supplemental with This the would well expectations approval our supplemental to XXXX. goal And a our be that

Pete Lawson

you. a And or is a is Thank just more see so -- then XXXX, differentiation. you'll the benefit on ability here, pricing? it differentiation to just Great. There control the

Michael Weiss

until know test won't fully. we it we So

-- I think tumor PD-LX nice target, to the in is again, there's differentiation a the about XXXX. a it's few is and right. it's One pieces the of part puzzle

body, But hitting the actually a that as PD-Xs other the cancer. -- their on your remove PD-X T-cell, and the of while it's the were own on engages kill might T-cells effect, which hand the engineered So T-cells, it ADCC body's on landing then itself, so while T-cells. the to it's tumor well to PD-LX the your sits tumor PD-LX would the PD-X. kill avoid lands having sits possibility they would and tumor. try right. there, on destroy of point on on All any on it sitting the with the

FCs ready that opening we have and for business. So

a So tumor. it has

we use only go PD-LXs and So know the through a also We'll of date limited is differentiator in tumors be limited, broadly yes, as program. it's to the of a of liquid function PD-Xs will the But is significance? relatively clinical relatively experience that right. and

have we bit. off approvals Hodgkin's in side so just the that So push little a disease, to

a You've rare a Diffuse literally B-Cell. we've of an primary approval in very which Large then And smattering only available. Large data there's got form -- B-Cell, have mediastinal Diffuse that, is after of

later. just pricing the So, one XXXX is of part not package having

you in trials have own permission the can't You malignancies. hem from without PD-LX someone your run if trials -- around else, really you run don't

that research patients them flexibility which the today. is So impossible for best for really we it's broadly, about for care building won about us, combinations exploring

don't a always, drug, with to you own agreement always you but your always, someone or If don't that you comes attached. with give strings an free have get

that then, it's its research flexibility. for this learning possibly again, clinically It's package difference So, how future sure. and in the pricing works, really differences a make molecule

Pete Lawson

Thank you. Great.

of is patients about of Just open, or I'm thinking as work are in kind plan? just since out MZL particular of CLL, subsets trying wide adopters the versus potential who -- academic, the game community just of first potentially as a kind in either CLL your kind to you

Sean Power

Yes.

more much community, we being So the do We centers, academic the our is to venetoclax being well straightforward. community see see is In and academic centers. the relatively well and venetoclax a options, between you're as more centers, going liked -- a market whereas game used lot in in of plan divided challenge. particularly the have academic with

the data a a perfect but of drug. oncology see community tolerability least a we've we've from we toxicity dominated times, space on being second seen, the the profile good But it's very honestly ibrutinib. appear drug, BTKs generation better moderately not And "BTK" multiple noted is ibrutinib as are at again, moderately toxicities. only by only So

no we alternative represents XX% for ibrutinib, good go up would you therapy. other BTK XX% which And There's and think good patients ibrutinib before the candidates of get Probably not candidates a be to based year over need another on So or patients on that almost market. they'd will to are on off that also the candidates resistance be good us. to to question XX% of for an that on that be would not therapy, therapy. going tolerability, going of are you're going two very UX candidates of BTK side then, fall alternative the for

If start from of patients just to therapy, value it's we opportunity have we is large there's the market. who to billion $XX the think UX would with realized of So anywhere use we across to a that's patients to really have a get in it for you foot then, candidates to it perhaps same often the then just the market, you good first of are market tolerate a you then think tolerability better share using door. outcome don't you and standpoint, you a not Once a us plenty add more and that for can us very, lines experience room good or XX% at -- very from XX% line, that in ibrutinib.

in plus those potential hand, in not number are of converge in -- reasonable that because both confusion and therapy go. good I market don't in the on into that to think academic you're ibrutinib the they think a once [ph] treatment who into therapy, beginning which on centers think I move potentially venetoclax-based our an potentially the and plus, be curative candidates going of who treatment, will options lot But more that's basic the you cascade built So toxicities, maybe of plus good find will Like for a that, options ibrutinib a ibrutinib-based we inpatients UX a for think the centers we therapy patient. a is will academic is large the And go or said, first-line two there's are growth even think little treatment I is for who something front-line like portion being venetoclax. not of and those will tolerate the venetoclax, the academic eziebah therapy would on minus again, And opinion, will patients academic curative the certainly or ultimately, a converge how centers. candidates we market. one more potentially centers, to options on all BTK mix pretty but there's be

right academically in an the sits good is tolerate you the that not don't direction the or that So to market next community therapy. they're offer option candidates that BTK and in moving when can patients need both to you BTKs

Pete Lawson

on the Great. so progress. Congrats Thank you much.

Michael Weiss

Thank you.

Operator

you. Thank

Ladenburg today Kaplan question coming from Matt Thalmann. next Our is from

line Your live. now is

Matt Kaplan

sense you questions. of taking guys. filing little step for zero can CMC, near-term just to bit Thanks for Matt, package. a manufacturing the in tox filing? rate you morning in guess, of the the wanted good are given Hi, NDA, the I in for a the on the give terms in limiting us where relative terms preclinical of more filing what's Zone preparation Marginal

Michael Weiss

hand, in all on feel like I they get I update team don't year. all that by this working is have aspects So end it done a and know the of but my current the I've informed they can been

package and of are if what your like follow-up that filing. timing and we that, with -- be team the I So looks that's any FDA of the they agreement think to an will for else and the the me coming required, assuming everything tells ready

Matt Kaplan

commercialization plans Thanks. there? for thoughts the U.S., then Great. Zone are what in Marginal your And

Michael Weiss

Yeah.

He is team. So, I'm build fantastic for person has exaggeration, side interests from to he talent and team we Celgene. who got help doing will build going this in to plan the create the is going great obviously, we're yeah, going We folks a is there's of both of been to commercial a We've organization. a of great Mississippi that of – what most from been quite But Obviously, area even unbelievable, available marketplace on. join inbound little the unlike there a is lot gorgeous hired he and us. think some top-notch this lot sure a the Adam what's commercial in to of Waldman following maybe side tapes commercial were who time, of has he Mississippi. bit really the

we to can to commercialize and umbralisib and together talented team able a UX. So be really think put we'll I

Matt Kaplan

conferences at going presence any have Great. question those number EHA, we the have what Are of the there? guess Thanks. presentations ASCO And type ICML, medical up at conferences? last I of with coming you to upcoming

Michael Weiss

Yeah.

in oral Lugano. several have we presentations So

oral we EHA. just at presentation to opposed and presentation We at an ASCO, have have

Matt Kaplan

progress, the good and on luck. Congrats

Michael Weiss

Matt. Great. Thanks,

Operator

reached Thank floor I'd to over We turn the you. for like or of Mr. any question-and-answer Weiss back session. further our end comments. to closing

Michael Weiss

And Thank thanks again, us for everyone you. Great. joining today.

and As key remainder of call, let the me objectives XXXX. some I the just of goals review the for wrap-up

to our about the to year and path of the provide FDA that Q&A quite have to will think goal again, clarity I discuss in hopefully But that Marginal to the filing nice course, and the in MZL well bit prepared we've And – to we'll to to give end. on foremost, and get by if boilable we'd goes following investors like for Zone. is all for the talked with that the filing be a first these meeting regulatory able we'd remarks. like a and that

year-end MZL a the conference. by final Additionally, major we're presenting to hopefully forward data looking at

naive line for year. up, available that survival we'll for data of for CLL end to the lines Again Next to getting have is And UX refractory. of top support hopefully, that the approval goal is again, of the free both that importance, data in UNITY-CLL. to by course, all of treatment progression relapsed and combination us

key where end we'll then, on agent there's year up, got year. We've the we multiple an have conferences the events, Also talked the this the have about, as the we'll summer and in Beyond single opportunity of data both across Lugano. will combination. EAAN, ASCO, toward summer, additional coming we've EHA, data presentations MS just present

umbralisib at as both some exciting well present be a are on we'll MS We as will lot have more and we ASH combinations. data presenting single data hopeful the and compounds agent, newer -- -- of hopefully, of

shareholders our have work along and day. of So, on science course, day our a course, it great here of of to every our help their again and at employees joining us, make behalf their of hard investigators in patients TG support happen. will and and our like participate move for continue and Therapeutics, everyone for all trials I'd Thanks who who to all us thank, to

Operator

teleconference. does That today's you. conclude Thank

wonderful this at day. participation today. may We time disconnect a for and your line you thank your You have

TG Therapeutics (TGTX) 10 May 192019 Q1 Earnings call transcript