TGTX - Earnings call transcript Q4 2019

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Operator

Greetings, and welcome to the TG Therapeutics Fourth Quarter Earnings Call. At this time all participants are 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.

I would now like to turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. ahead. go Please

Jenna Bosco

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

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

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

to the XXXX company's well quarter Power, turn to to and year financial condition. results the like for over would fourth Sean I the our as financial Officer, Chief Financial discuss call briefly overall end as Now the

Sean Power

us. Thank and joining for you, thanks, everyone, Jenna,

our the website. viewed results section may were can and you aware, be Investors our morning this on and As released Media financial be of

financial I'll our results. quarter fourth with begin

to few decrease. past loss quarters, the our continues net in guided we've As

non-cash was the the the for compared quarter fourth XXXX and million our Excluding quarter December quarter fourth in $XX.X XXXX. in items, XX, third XXXX million of $XX $XX.X approximately of net ended loss to million

we've and decreased as to expenses. is compared net trial to clinical primarily quarters seen decrease related manufacturing The the in loss reference

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

December Phase and items, preparation Our net approximately million, which III loss for of year approximately million non-cash trials CMC was ended expenses and clinical manufacturing XX, for $XXX.X excluding the commercialization. in included XXXX, $XX for

GAAP net $XXX.X loss share net loss or items, ended for XXXX. year inclusive The was December of non-cash or million ended for $X.XX year share compared to of per XX, the XXXX, million December $X.XX per a XX, $XXX.X the

our near our Turning continuing manufacturing the bulk million. cash clinical cash, securities expect ended major term program investment near the now position. ULTIMATE-MS us, We programs, costs of to that $XXX.X of costs we year With continue behind and the to with UNITY-CLL and now decrease. and our cash completion will to R&D equivalents our

MZL and potentially to expect and operations modestly UNITY-CLL in ULTIMATE-MS, readiness our we for cash III sufficient to first be our readouts decrease launch well commercial with follicular. approval into and we fund costs, While and believe offset well that will XXXX, as Phase through as some our our importantly,

turn will to our the With now Mike Chairman that, I Weiss, CEO. and over Executive call

Michael Weiss

the impactful XXXX us joining a Jenna. this Thanks, exciting Sean, great way. for and Great. for Thanks, multiple catalysts start everyone, morning. us, an year to thanks, XXXX is was and on off with

everyone's of and great XXXX, an want top on I to accomplishments the minds. UNITY-CLL, what's review which, of I before start update in with is for But of all XXXX store on course,

is everyone So of combination the GAZYVA. trial as GC. the obinutuzumab, the let chlorambucil, referred chemotherapy, clinical which combination to me a plus as that study CDXX, UX randomized remind the versus marketed is UNITY-CLL This of is

and special This trial is the protocol a once is occur. or conducted progression-free primary the The is only trial, event FDA. a disease a number with under of being assessment is an can dies PFS meaning their certain A patient PFS endpoint progresses. events survival, end event-driven when

the takes is to hit that than not of the for background, greater successful that for as a update a have this positive yet occur, a events. and confidence to events To in further sign the arm. benefit outcome, the UX requisite point should the longer reinforces a is With it number we very quick our us, because expected

GC in Based in events or on than that months, ramp events our several significant we over not believe occur. are we the a significant either which a have the verge modeled. benefit UX on uptick greater over past would did is we originally expected of providing original arm Accordingly, projections, the

is the performance historical fixed assumes relatively course, of GC range. its That, that within

we slower-than-expected explain factors, rates. are outperformance blinded all to performance the event the could since efficacy other However, - GC data, fully including

of we be ruled it it's out. number that reasons, can't a believe certainly For but less likely,

some does in leave like to you. is additional with us good The that answer terms where relatively unaffected a of here? as So result share news from timing short of we'd

with benefit. us interim are is the unnecessarily allow results protect for the an we early outperforming, would to PFS greater-than-expected where analysis, FDA because to efficacy against agreement stop the and reached UX which study conduct of the To that, delayed, scenario an

So have more with than next rate, events days XX to over then despite the days, the XX necessary to the lines and target we analysis no to ideally, still positioned are thereafter the reach deliver to XX discussing data and close event to a we reasonably time announcement. slower-than-anticipated been the

remains the an line this maintained, overall which by As importantly, submission this is to line of time assuming complete intact, to is our submission NDA/BLA end time year. data

trial. you UNITY-CLL the the excited successful about As can we're for for PFS a tell, prospects outcome

willingness to bringing a the forward look to and closely study including efficacy FDA's appreciate greatly to on analysis, PFS us conclusion supports if also we that. with interim the the data work We a

over With of quick past a major months. that, our the XX accomplishments of let's do recap some

stole the spotlight Our MZL, follicular with the zone with first, lymphoma, from data the positive lymphoma later the marginal cohort. cohort UNITY-NHL XXXX, and or trial in

As of both refractory a follicular or dual and epsilon inhibitor monotherapy PIXK reminder, delta MZL or our cohorts used umbralisib, evaluated relapsed CKX these of as a in patients.

approximately received profile. well-tolerated at rate For MZL response we overall presentations we complete the and XX% ICML announced during response approximately a cohort, oral a presented preliminary ASCO and safety a therapy data breakthrough demonstrating generally AACR, and XX% with rate designation

for treat orphan received also to umbralisib drug We designation MZL.

in the to dedication extremely quickly of and NDA completing guidance announced the by new incredible too sites met we both overall a both endpoint the effort of for have importantly, to follicular that our to committed I milestone year, for first-ever drug For a for want we're the include us. was to single cohorts, of follicular Initiating for thank they end umbralisib. our and possible. the lymphoma it rolling primary the a as NDA cohort, XX% FDA's XX% And application initiated our And MZL as a towards submission. pleased major this team we and clinical submission submission response.

multiple releases, published combination in Phase of had triple and combination the we was which with had the the the of umbralisib, Hematology; ibrutinib publications, including also the I/Phase Phase evaluating and published UNITY-NHL ublituximab, UX, XXXX, presentations therapy in In Lancet addition tremendous publication to data program UX, and we Ib in progress I Blood. trial

data monotherapy a data that ibrutinib ublituximab with in patients conference. regulatory is in medical announced ibrutinib the future over relapsed/refractory We the years at with also determine GENUINE high-risk any combination We study to after to such almost improved data plan follow-up, plan CLL. if use PFS share for of FDA our the and X demonstrated to that present there with

And at the two at conference, year sets combination of the end therapy we of ASH presented data. triple the

venetoclax, where was introduction BTK XX% the showed venetoclax. months The pretreated data after presented the of is That response we to therapy. that patients CLL, UX of overall refractory. was This triple in an relapsed/refractory prior some of X were of whom early heavily combination just first with rate UX plus

a peripheral venetoclax marrow. and X XX% we a undetectable of added with we bone an in period MRD after then a reported treatment blood response And rate a XXX% in for MRD XXX% overall months, additional undetectable

numbers, study, including this this these combination patients. therapy triple significant through pretreated potential small data has patients more preliminary patient heavily in longer that from these to additional results follow-up. suggest We While a look forward

study our is us be The our TG-XXXX, particularly second significant presentation data This with that to data at UX the step ASH therapies novel was therapy the BTK in from inhibitor, important first-ever represents proprietary each used to TG-XXXX. forward combination plus mission develop can triple a in it as first-ever other. clinical from including

we are making accessible be believe if where conducted component study combination approved. drug triple first vital the candidates, patients, that all proprietary these pieces TG is something a to the to combinations This will

our Finally, and on side, TG-XXXX, Phase we initiated first the anti-CDXX/CDXX of compound. clinical early bispecific for trial first-in-human that data antibody, also preclinical I presented clinical

of mechanism action and with into as UX soon excitement move generating excited are we possible. to some as combinations seems This recently, be this compound to

With prepared in me a that recap look highlights of remarks ULTIMATE-MS recap our of for with to my some program let XXXX, XXXX. what conclude of brief and

and multicentered, reminder, dummy, quick forms X trials oral are independent, comparing randomized, ublituximab trials X active-controlled of ULTIMATE in to MS a X Phase double our As III double-blinded, relapsing global, teriflunomide.

approval treatment protocol is XX under to annualized and endpoint assessment MS. of submission following support special conducted full the FDA. relapsing being trials The for of and ublituximab study fully enrolled in each are primary relapse of forms rate with These for designed weeks

top second trials We line year. targeting of data the in these this are from half

important and role We usage in in only in as for physicians sales CDXX more utilize The approximately of in continue the global $X earlier billion usage class MS, with CDXX treatment the paradigm. its quickly the growing an plays CDXX treatment MS believe class will approved XXXX. seeing grow reaching to the

price. be very market, ublituximab's this with in will at infusion significant a X-hour competitive We offering shorter also patients competitive MS, believe to profile a by value providing

believe the see, you year we As can shine. year is and XXXX to us, really was impactful for TG for but an XXXX exciting

approval; we see us the X ULTIMATE-MS half and data-rich for CLL to our for of by over and which are the data before pivotal NDA an of Our MZL, for in half completion we is the targeting followed No hard look if well all exciting trial, an first this work with UNITY-CLL, an on our all past data clinical our possibly second submission first we here, has doubt, forward should XXXX NDA/BLA NDA years year; goes year-end. of from UNITY-CLL, action-packed where by way. the followed submission, XXXX brought FL pivotal and

Q&A some make concluding With to turn over remarks. begin to that, conference the to session, will to following I'd operator return I call the the like which

Operator

with your Instructions] of Thank Alethia Your you. with [Operator Fitzgerald. from proceed question. comes line the first Please Young Cantor question

Alethia Young

and yes, Thanks questions guys. lot it of just like to it's a XXXX. exciting seems three. I'm for curious some GC, sort going hypothesis. Hey, like outperformance? that's in that progress, about with taking the the an my and is on there must congrats I little One, anything there Maybe just be be related maybe a to being would figured baseline used - lead its to first-line of or

trials. times, are a then And lot kind interims decided secondarily, of in of on earlier

wondering and to guess So an I spending broad you I'm strokes you assume, say interim aren't points - guys I you the of comfortable that? kind alpha, they're what FDA got comfortable that the that do and taking

mean, that XX And should think, bolus than before what occur think? it like there next any I like, there have occur faster there the an is is, if in could I events some risk were question sounded interim Thanks. any you days? occurred? risk the - And the now that, bolus is third

Michael Weiss

Sure.

is is mean, personal a GC PFS. So study where outperform. think first we that question certainly going outperformance. had I to certainly And is the about think on it going GC I underperform GC don't our to CLL-XX XX-month belief

recent Those it trials, months of XX had and PFS ELEVATE, months XX.X in ILLUMINATE PFS - are XX in in more In patients. ILLUMINATE, ELEVATE. or frontline

that approximate give relapsed remember, for take, just in half, or an the going patients. you're cut to So almost

GC using it think would that the CL-XX. that closer ELEVATE patients than for we be more be So going and PFS to to is to the ILLUMINATE likely it's frontline

of the And the major think, contingent that all is recommending we patient One for they the two. waited, treatment patients. scan. basically were in I upon did They CLL-XX, period. month basically treated reasons They or the the - a they future then investigator that X-month scanned scans the believe a X-month

office an for don't for that in come believe they progressing, So don't scan. If they a them they send visit. they're

ILLUMINATE, scheduled ELEVATE were and regularly scans. UNITY-CLL all

then XX study, So every X and it in months, I I on months was thereafter. every think, believe the X first months

looking and you're missing, on end on doing that's investigators up we and when ELEVATE, UNITY-CLL it, feeling see own, think between I our they're So ILLUMINATE, that for other the when is you'll hand. the difference more. just The CL-XX, their

don't we is wouldn't outperforming. sense. chance GC much that there's again, good So that any really real believe It make

with We recent of lot the have a drug information combination.

point. So that's that

In the analysis, we terms worked interim FDA. of with the closely

we what part and the which of information that we available started data didn't UX We ELEVATE think, also again, the we studies UX. umbralisib provided we any when them I And expect that. to when for didn't we and for was ILLUMINATE the that we - have. real like both what study, have for was information have and didn't study, UX, didn't progression-free on started survival, we'd

was studies. I UX - closer alone well, XX studies out the about In months. XX-month U the those PFS to of a recent that the Phase in coming been has presented, have UX

post study, think, of market them, both and on again, get starting a lot appropriate. interim. when adding GC the that want I to that - to the is with So us to think see available, information study UX, I their again, drugs they the and publicly And - on think discuss was helped I

So interim. about concern I don't there's any the think

that I then wrote last the And risks. of any was What just was question part last - three? part the question,

Alethia Young

was It guys events had of question you I said bolus there like, come. was a to you expected think, a just

trial - the now you wondered, the get XX events are to interim meaning days just I of proposed you any So your the like, before to final before risks bolus now? an there interim, that the interim get comes from that completes

Michael Weiss

them. then If then few information. mean, come and because there don't it next final in event fine. so, ends analysis either batched, scans a up a it us being months, The but get is I and would be large bolus we way do a getting over think lag in, we get I the they're in

impact get mean, final analysis? a will next several big there that the It's bolus So out possible it be and a bolus times go that won't but it's And scan it is - a possible. good It be does, likely. - that's yes, fine, sitting fine. really I we there, there's us we don't I doesn't thing think over then flattened if for to in too. large way, and there, has will in us. pretty This any reports,

XX take. in range point I last - when this trial, the are or give in. - in But months take, we the are give probably approximately, in follow-up the Median at patient from this at which or we in think we're is month XX-ish point,

So we there. are out

- We beyond we are the well in most rosy beyond scenario, the GC even median. are well

look in is - and with studies the ILLUMINATE many looking point. CLL-XX, will as - the even events about provided this as frontline with GC provide GC at obviously, at at you If have going at even to and ELEVATE, this

events. the GC the So patients missing all course, those one expect up of - of that given relapsed already have front and would, -

maturity, of up have of bit given their quite a UX events. point relapsed at this one the will And arm

the missing and and UX So what in benefit. we we're that is frontline why we feel a difference what patients, link that's substantial is expected confident the seeing only

a But come I don't think If that's risk. events in, those it's great. do

we'll go we have So when powering. based original all already But final a we're well we the analysis. those on to had thought events beyond would

quite is events frame were had powering for these back, we a through. why that's the this this, that's passed some which go certain our frame. about should talked time is just in I and correct, we've to events And expecting - in were mean, just saying, And time the we look, expectation the we we where time, have if

question the no the we've it is If see there's think, it didn't not, short great; if again, answer that's got risk. interim. happens, to your We I

We're be interim we've So point. at have to final, going that via in completed a we essentially to the - hedge, this interim going either via be via the basically. It's likely to study's the an frame going or more discussed. time

Alethia Young

Okay, great. color. Thanks. helpful That’s

Michael Weiss

Yeah.

Operator

question Please Ladenburg comes your with from Thalmann. Kaplan of proceed with question. Your line Matt next the

Matt Kaplan

guys. color. morning, Good Thanks Hi. for the

the bit - more a of dig Just it's us, - the into into just since wanted little mechanics to for new interim.

your of but kind to remarks, kind the how of stage walked work? kind again quickly you You it's prepared in can set how it and work going of will through

Michael Weiss

it XX Yeah. Again, set days. will expect straightforward. like relatively for in is be be interim events XX number hopefully that mean once are a we those I in, to next which, there said, of those will events the we in,

for that basically Soon lock can database as the that's you interim. in,

and it'll scans they're than all is which a there. hopefully, no sure put then And take reading what XX data get There's in the there making to basically is more days delay together. that

And should thereafter. soon out data the so have once that occurs, we

Matt Kaplan

So that arm its GC potential analysis, that I hit PFS, did it's median while on guess not. you that UX interim could UNITY the see

case, in so on? you that that set median PFS. a still its And Is hasn't it hit data could file

Michael Weiss

Yeah.

all on So ratio. based it's hazard

So the hazard the useful are into curve. entire differences, creating ratio the medians account takes but in the

in in by in the arms the just stopped. when were MURANO, CLL-XX, in studies way median none active so of example, a ELEVATE, And ILLUMINATE, of reached

more not - to median reach them reach to than median. the studies actually a it's see rare So in see active these it it's arms recent a is

and those all special the So it's no, this protocol is they necessarily assessment. a studies, a need median to - for course, interim arm. active hit But were And it on based under have does of hazard obviously, ratio, the not fine. and

Matt Kaplan

in program. of, in a you. reads I the MS know, I you to your switching what relapse positive little terms And that us sense ULTIMATE be guess, of rate, out pipeline, the just the of, Can ublituximab bit if terms Thank Perfect. give gears a could market? position in

Michael Weiss

Yeah.

market. the at we that that, this will would third expect to be point CDXX So

mentioned XXXX. earlier, on ocrelizumab, and billion we You've is selling, $X is almost market in which as the got

the mean, market, ARZERRA, be side will the and be I'm will cancer and and It FDA, not come so forward. rebranded application on months in That is I rebranded. will name that after so in is what they'll the or the then the sure X X be to new to that. brand Ofatumumab, on next expectation formally is. brought we in the

there's other MS. late-stage knowledge, development my for in or CDXXs development To no in

portion think be that competitors. X frame at market the CDXX I foreseeable for least will time So this locked the as some of

be approved, of two and gets course, there'll we and injections infusions positioning, drugs be of be injection. terms of of will a subcu X on get and market, - In X IV a X assuming, X ubli will the that ofatumumab will take-home drugs, ofatumumab the after will of them, ocre in course, assuming, that month be weeks it be subcu row every or approved there office, in month

So it's access. It is actually and we've down be personal preference personal preference, what going to will come to been hearing.

So their want access patient able a be be the ours a depending very infusion, have will for profile. if themselves, discussion want to an currently is. all hopefully But price. what competitive on infusion do will they want If we competitive very versus preference a Do them with to X-hour infusion the compounds, ocre. X-hour they has IV We'll have on IV think a X- we offer an to to self-inject they X physician a infusion?

well a we'll even product a think to the bring with if if I patients again, factor. hopefully, financial And quite be can we that impact get less of could the can it - try we do done, themselves. we're convenience So to

in nice CDXX to of by of upwards marketplace. a It's are treatment pretty tight this billion the could shared $XX portion got position be could a X be we've MS think market that just this market. - I Projections be companies. So

about good place we're I excited pretty to think And obviously, it. a be. that's super

Matt Kaplan

fits question, the with there's Thank how class you. for And been you November, the give some building of more since landscape? detail yesterday bispecific billion. anti-CDXX you culminating I excitement products, guess, $X into around that last anti-CDXX XX - us your program? buyout almost how on Can that And Great. then

Michael Weiss

Yeah.

I limitations. CDXX and this way, has, positive say in our So a some

to basically attached a been CDXX. it's So

this positive there drug and So cells. There's a to this CDXX antibody. attach CDXX is to arm. designed arms to specifically CDXX And is a X arm

for should of associated naked focused on find to like the we're treatments malignancies. with for ours, patients company a news further good good malignancies avoid exclusively is B-cell where complement that that our some with to CDXX that news CDXX is hematological ideally B-cell a So a mission, perfect the landing on And toxicities targeting is is it the which on basis. best the available

it's in its it's highly with blocks activity a the CDXX focuses and On the that CDXX, malignancies agent. CDXX. combination on that what B-cell as with once other And targeted mixed It the single it's actually, So on there, own, naked own, dramatic with CDXX in you it agent are positive is engages had compound seen and we've its relatively CDXX once inactive version. a CDXX. cells,

guess, two will drug one, has then, activity similar So compound. have CDXX-like ublituximab to own combine a things with since of its this a activity have it It of has I we CDXX And already note: course, arm. CDXX. to this

UX, So CLL, are to CDXX our with in UX like marginal quite looks follicular combinations particularly to and of zone active. commence excited very where the things be we

B again, combination diffuse CDXX in hear still looks more, but And CDXX we're waiting and interesting. the to quite cell, large

looking So well. ours as trying that in to we're setting forward

Matt Kaplan

on the Thanks, And progress. Mike. congrats

Michael Weiss

Matt. Thanks,

Operator

of White Company. Ed proceed Please with Your & question line the comes H.C. Wainwright with question. from next your

Ed White

Hi, guys. morning. Good

Michael Weiss

Ed. Hey,

Ed White

Hi.

see just data follow-up will on from this it's the we the When a next study? So XXXX.

Michael Weiss

So you're saying generous being next. by

first. meant really generous. Very You the

will I because shouldn't all through reasonable all, the phase. would first Well, be not present able ASH, expect of dose would the I sure, Phase be a But trial. data, portion, So not escalation I it certainly for there think, certainly, be sure. that, of I we'd the longer say expect I will follow-up. we for by that, to if

to we We and there, start a most think And to the once the do EHA is do finding able to at the escalation. combinations. dose. get likely - close EHA. time early We're more that ASH some we expansion possible scenario. some we'll data I be But some dose could then we're It's think it's in getting

the on the but trying out So we're dose. still to precipice, right figure we're

Ed White

just Mike. And to very Thanks, This ULTRA-V great. Okay, on trial. the exciting where paradigm, trial, ASH. data if fit talk it's for expectations II you Phase about the up? an the can the And and give if maybe just ultimately, in us at update treatment going your data holds was

Michael Weiss

Yeah.

taking is ULTRA-V off. So

really as started are about we the kick enrollment or take, into to this in give early a months but been has got the say X so. last we're way in, to through in year, I'd starting really of of So third all roll things which the part we're, or still along. enrollment, but it's the

So it's moving quite well.

enrolled have of end is goal to the Our that the fully before year.

I would XX-plus open to also II, have the patients continued there. X we also think, and mention at I, maybe at but think, X, multicenter I enroll, is Phase has that just ULTRA-V in sites least do which I a larger at, at we're Phase

we XX-plus collectively, plus venetoclax patients, have more So may at maybe this time. on combination even the UX

be a forward looking year update at hopefully a significant of will this ASH patients. we're with a nice - number to So

trial but to this of way no we it, the - want is at XX drawback marrows bone only the basically look undetectable MRD. that design, there's you is where assess Again, the month to control

drop putting the So ASH, risk. coming to but low them have take months to and XX through patients patients we'll down through at and we'll things the periods, interim show, and many actually we have obviously, able together safety venetoclax profile ability high- and be how to this patients these medium-risk we'll see

So there'll information. of plenty be

the And It's now, plus academic is see Right today - pretty the all primarily centers. are but venetoclax this well-known in the not that folks. as it UX Where in think as it's academic in for regimen some end, the as used to venetoclax? certainly, popular do I popular is used community centers, not centers. to it's reasons we

like the venetoclax, not believe when the UX. want use with over obviously, think Obviously, they this a folks with combination obinutuzumab, that data they - it's would want venetoclax that you have want And and to we community. anytime see we venetoclax We But to will venetoclax with up. is, to they the to a venetoclax consider. we use holds do from that academics, physicians we use to into we the it Rituxan, want presented, want accessible years, we'll whether but to use want least just with whether be sure make lot something that it across think that if early We next to UX. there'll at - use is choice, X data, it more be them

But as we've seen the the more in seen holds up, But far, venetoclax. it and numbers, maturity. data with if we've need it's combination we we'll again, case patient all that best make small And thus a that if you MRD want is want using to plus CDXX - simply - is UX venetoclax chance undetectable your with you patient using the venetoclax better to the best of a getting versus approach.

that as that we place. sure venetoclax But think UX to first the to years, And data use permeates make community, the that that, well. would be So be are next over able supports academically, venetoclax again, want assuming X positioning, our that the that. as would folks we with

Ed White

all higher non-cash Sean. of was the maybe new a this significantly Thanks, Great. for G&A, in or last a Thanks. quarters. versus pretty much just is fourth is forward? quarter base Mike. 'XX onetime impact? What's prior if the going if going wondering this just question And comp on The I'm here

Sean Power

bit likely a that new Ed. say a from tends be to than base. Thanks, it's bump in to quarter. lumpy little I more onetime quarter a stuff That would

Ed White

Thanks, Sean. great. Okay,

Operator

your of proceed Chris Jefferies. with with Please the Your line next from comes Howerton question. question

Chris Howerton

Yes. Great.

most interim think were a analysis. maybe of the just of questions I couple important asked. clarifying to the So And ones respect with

the there outcomes happen an size result only? sample Or of that nature? increased question as a is the can the what Is something that with are this success, - here? So failure analysis, perhaps would for possibility or interim study actual continue a of a that

Michael Weiss

Yeah.

the question, Chris. thanks So for

started events So of the a that set trial. the maybe there's final events the sample of been for but we that for the size was number analysis, final was - I total kind predetermined analysis, that's a earlier, as clearly, is when so discussing not

interim. There events is is set the another smaller that for of number

So yes, study would the or the there - could final efficacy for X on stop continue could outcomes to that is analysis.

events. - to back which I there if also for spike the pretty of point If studies a to see the going with to stop not final analysis, to not statistics we're mean, final and inconsistent life again, in soon. it's and - our the goes events be with should a

Something has to give.

Again, study to in is next going so few have or so it's the is well The no a up in to not that any unless magically, happen wake stops things be be of we're differential. the events. ever than much also, there to better a lot been can't either. It working and one events, inconsistent it's new weeks, because GC two going trial, is that just there of there's and it's

Chris Howerton

the to that of Sure. relate it Like patients a would percentage guess, relative could might are And much that terms us be then, maybe I a interim? in trials terms And this how PFS-driven full we about the how of of big reference sense. you frame other here? patients? talking to difference are of give required of makes totally for for in PFS a of percentage event Right, the

Michael Weiss

as this how impact are being don't I PFS. speak would to know other reported I that that studies could

Chris Howerton

experience other in trials, oncology have analysis, a Not an PFS-driven final that your that and of impact. relate trials both would of But the event patients just are they percentage terms nature? percentage patients require certain to just interim How event-driven this need of that the their would with in of event. other you

Michael Weiss

to I'm still I you're fully just that. about Yeah. going - think asking, this question I is - question, the I'm but sorry don't understand I think I - a that to answer think, which mean, going I Chris,

consistent with other where stoppage analysis is have the been studies been early for this activity? that conducted in I interim relatively B-cell there have space think

Chris Howerton

that’s Okay. Thank All right. my questions. Well, in and forward I much think to you of all so look future. updates the really

Michael Weiss

Okay. Thanks, Chris. Appreciate it.

Operator

next from proceed Your B. Mayank of Instructions] question Riley question. comes the with your [Operator with Please FBR. line Mamtani

Mayank Mamtani

you congrats the taking for progress. my on Thanks and question to

on dialogue value originally. there to around I UNITY-CLL. was a study the of curious also on rolling that follow-up Just were arms a If or of some if mean, interim were of part I the the couple recent then that full submission. added have - question I the monotherapy And just analysis? the any

Michael Weiss

Sure.

the So our from other of is no. that conversation. the the new outside and were arms impacted not trial just answer on timing The that short studies discussion. of the based agent single It of is purely information part events

Mayank Mamtani

on Okay. a median median clarify maybe there - reached? Is a there that, that, that is been has on

Michael Weiss

don't have information. that I

Mayank Mamtani

on could submission, to just of for particular is also a rolling the the the elements is follow-up, when non-clinical informs you kind then or FL a I'm - need And and the I submit filing of lot it package? going curious, submit data that go there's great. there follow-up, MZL even a of in. you understand and there Okay, cut

Michael Weiss

has there the by but to Yes, is, follow-up there it FDA. pass. so minimum definitely So was requested a

that disclosed actually exactly what We was, haven't is it but now passed.

are So and everything and place. the cleaning our databases in locked, they're getting CSRs

it's But requested all was from minimum there so yes, FDA. a And happening. follow-up the

Mayank Mamtani

and Sean next Okay, maybe both. one Mike great. And is the for

next understand R&D, is of studies I like are lot the XX a might at earlier-stage about. the dose months a thinking about be that study which is you which to XX As think bigger you - like months, escalation.

if like the of larger you for months? advancing regimen finite duration think a to get CLL. in a that about XX But the should be what we could expect study cure maybe therapy Like to any triple next

Michael Weiss

Yeah.

of trial next one a zone commitment lymphoma a do considering goes we are well we trial. assuming the things XX to we thing well, approved, marginal in have think randomized part I post-approval follicular run will - - and months, in to is a have will get and have all as So we randomized

- next approved, study certainly start So be have to XX within months. to on when that will again, of that would study the hope we'd lines time the based

So be one that would study.

turning yes, months. positioning III BTK the and back then, are like to our Phase a And trial next to triple inhibitor would XXXX running within for get XX ideally, the up we therapy, we that, plus UX

but something Some to that identified like to is of we would combination for together, the contingent do is right it sure on possible. making as be able we've the dose

- UX trial venetoclax assess would the be it And would whether other part plus a be of the then other is to one required. randomized

And an the going assess data for I perhaps plus We're look on docket exploration. approval, which would for case, not well. randomized. that's Phase triple for if data certainly accelerated usable, that - were the consider combination I we'd a if that randomizing requirement lead the to that a think, that's, to data it the as of starting ULTRA-V So our also usability would or and certainly at

Mayank Mamtani

Great. Thanks for the helpful color.

Michael Weiss

Anytime. Yeah.

Operator

have closing call Mike to question-and-answer Ladies session, back the Weiss and we the for the reached Mr. turn of remarks. like gentlemen, I end and to would

Michael Weiss

thanks very you Thank joining much, for all us. Great. and

once reviewing just key call and upcoming objectives. by goals me up wrap again Let today's the

have the line we XX first from Phase top So over days. XX trial and to expect UNITY-CLL the the data III PFS to foremost, next

first Soon of thereafter, again, for patients targeting marginal and first with NDA lymphoma, lymphoma treated also follicular our year. this previously submission we of zone half completion rolling are

all UNITY-CLL, the have targeting again, submission early all towards UX for could Heading that of continue XXXX, relapsing of in assuming to before III And line MZL goes like with And will advance in year. the into as And like the Phase the top also well pipeline half, pipeline, the year, finally, to development for then - have to, course, ULTIMATE and XXXX, our but of goes we of second single we and/or our all XXXX, from end by we'd products. also are other we'd end the in end combination agents, MS. we well, the data if approval possibly the trials year, the follicular. first

our and in thank, course, for support. employees wouldn't us of be shareholders So investigators and our be patients. we on wouldn't all like of of behalf course, at them, there; their I'd also without them, TG, of continued our their anywhere; and to we Without

for everyone, a again, and day. joining have thanks So great us,

Operator

today's conference. This concludes

may your lines you this time. You your Thank participation. disconnect for at

TG Therapeutics (TGTX) 3 Mar 202019 Q4 Earnings call transcript