TGTX - Earnings call transcript Q2 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greetings, and welcome to the TG Therapeutics Second Quarter 2018 Earnings Conference Call. [Operator Instructions].

As a reminder, this conference is being recorded. I'll now turn the conference over to your host, Jenna Bosco, Senior Vice President of Corporate Communications. Thank you.

begin. may You

Jenna Bosco

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

provide antibody, Chief Officer, to once-daily who'll executive financial Safe well then results anti-CDXX inhibitor, Harbor Financial turn development Power, clinical on Michael brief company's of our a Executive ongoing the TG's Sean our provide and overview Officer, standing. over our Weiss, as an the ublituximab; programs update novel umbralisib; and Chairman company and as the of Following glycoengineered PIXK monoclonal review Chief call novel overall statement, will of our our delta

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

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

Sean Power

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

position. $XXX.X The our viewed www.tgtherapeutics.com. an the positive of be of begin equivalents, may quarter-over-quarter the securities cash receivable compared at of with website financial and of had ATM we & at our sales our $XX June afternoon I'll the on during XX, Media per a At share quarter price million Investors cash $XX.XX you cash, can this at financing cash were result investment the of aware, to approximately results end interest released be section equity $XXX.X and average million million improvement our facility. was in from position in our first As quarter.

reaching be could reach contingent our thus current toward cash be The XXXX. will of position the progress full XXXX, We will investment that half wind expect in to only continues 'XX, relatively the to as burn our cash a fourth program bit programs enrollment. of XXXX. full 'XX quarter variable we on enrollment. clinical and our registration-directed expenses of our somewhat program precommercialization sufficient into key with the through our remain into increase the down will operations second the to quarter clinical other UNITY-CLL to consistent Into and MS and taper fund and approvals regulatory burn third Collectively, CMC significant the expect as we be believe

in items, the second share, quarter the which Our second loss and million $XX or million, of was of the during excluding of loss included trials period net million, which net a of both over registration-directed XXXX, items, XXXX, comparable increase expenses approximately clinical for to quarter $XX.X compared to MS. or per in noncash the $X.XX trial oncology primarily quarter in GAAP $XX.X approximately an XXXX, was $X.XX attributable XXXX. comparable per noncash in of our The inclusive net $XX.X million, was share, loss for

Chairman III GAAP net June June of months again, in $XX.X six XXXX With the trials XXXX. turn over Mike share, inclusive expenses the six $XX.X six XX, CMC $X.XX approximately our an call months preparation primarily The $XX.X loss comparable and was $XX.X registration-directed million now attributable in June was trials million, to of noncash compared per loss million, $X.XX ended which in ended clinical the for million period net excluding or I the Weiss, in for for trial over XX, ended will XXXX, for included MS. million, and increase commercialization. for loss six that, included approximately and XX, to items, or are the both June net months share, clinical Our oncology Executive per and items, months noncash to XXXX, manufacturing in Also $XX.X of expenses our CEO. XXXX, of the Phase XX, a ended

Michael Weiss

to thanks, Thank know approval. a you, tirelessly new working Please the and and every Many they drugs interest will need vigorously seen advance want we hear day by patients Thank their who morning. our about to are that, value be in of hard into the tolerability, benefiting patients joining to confident value. kick mostly call off for we long-term and our Jenna. build treatments. been extremely toward shareholders everyone, our have eventually mind, from pipeline to best to seek we've are And I are We for develop support thanking patience. that all but shareholder confident translate variety our drugs. this to with improvement, of significant you, us reasons, for Sean. that [Indiscernible] working continued this shareholder

in The either venetoclax, before the or was venetoclax. can time these the has go-to combination or patients second-line of shortest potentially deepest become also can't goal and with patients get who CLL get UX about the amount both. occurs. BTK We Fatigue crippling. BTK, response regimen in combination them with the resistance ibrutinib, in with alone across a tolerability like off first-line tolerate be universal potential to and or inhibitor, or to proprietary own drugs hear treatments and

are to our as We very own extremely have preparatory treatments These for times us We well believe at BTK non-Hodgkin's your who that of of and never trials important novel have CLL on as novel better for exciting and development lymphoma, triple our sense and our little the in reach. planed the believe are cures are in and positioned with patients why a about anti-PD-LX to as and truly within inhibitor, well support as with company, so we're gives quad our CDXX/CDXX what's future bispecific. here. combination need treatment is venetoclax we going just our Hopefully TG a of excited options. as We been success.

overall months. the trial, UNITY-CLL have end will top announcement events the for before we occurring milestones are most results Phase significant, value-generating over the targeting course of We be response course, which number from exciting the summer. III of a announcement of coming line And of and of the for the

current the ongoing I some our I Before of status providing of highlight development the notable achievements an thought on programs, for update XXXX.

Phase target First, very of TX showing in ublituximab, this incidence updated elimination of we we the remaining the in the MS continued our now with single-agent patients of an that toxicities In at Oncology. long-term and, demonstrated that sets on to ublituximab meeting, dose up Lancet with umbralisib a up umbralisib. including safely safety ability relapse presented II annualized data XX lesions, in from certain important volume of longer-term TX year, well. We've we gad-enhancing Neurology five in study to have very years publication data presented importantly, And show the of follow-up some analysis lesion to trial, complete weeks reductions very follow-up presentation, European rates. of I for number umbralisib presented Academy also finally, low patients Phase to

drugs In development. addition also under important targeted expanded have B-cell to sets, portfolio data of we our

vision develop Our functional cures mechanisms. is key so, to multiple agents across B-cell do need cancers. targeting we to And

novel well anti-CDXX/anti-CDXX TG-XXXX. TG-XXXX, bispecific to novel A antibody So molecule. known important BTK note a about far added this first-in-class as we've year, few a this points inhibitor, as as

the bispecific this agent Accordingly, be of antibodies, X a First, could weeks. which have X true approximately is to traditional half-life this [indiscernible]. should

unlike agent CDXX-targeted B-cells this This the this arm. to Additionally, concerns this by attack of And is CDXX toxicity finally, agents, agents has agent other retained class. avoids including in CDXX activity. other designed specifically

for efficacy. dual provide a should also drug this mechanism So enhanced

broadened have Commercial head Adam to Waldman Adam U.S. a bring Officer. of at Chief our with of and this hiring best-in-class year level marketing And high this agent. products We be senior market. formerly team finally, hematology/oncology that our lead effort will as of Celgene our will a to was we've confidence CDXX-targeted management our

Let me III give ongoing Phase the high-level overview a programs. of and pivotal

about Phase First let's III and UNITY-CLL program. foremost, talk

UX For to combination this in into both Phase Enrollment patients those and control refractory chronic included and treatment lymphocytic our FDA arm global active was leukemia. or relapse Special patients as the of trial expectations chlorambucil XXX completed as of Assessment an first for of XX% large you frontline trial in under patients. are patients. our this joining of XX% The well over plus III Protocol comparing obinutuzumab is with the naïve conducted trial, time, us XXXX being October trial and is ahead schedule relapsed/refractory is and including a exceeded with a approximately

It data targeting are response rate worth To As trial are improvement end about of also theme, everyone which chat to previously response support by summer. survival, guided, rate. reminding the line expected we remind broad from let's CLL. overall this top the GENUINE the is overall with trial. combination label the bit we targeting full a a absolute study in to and UX of of a approval everyone, very that primary the our CLL ideally treatment endpoint progression-free the is is little this support for XX% Sticking

III ibrutinib ibrutinib is patients a GENUINE reminder, a As randomized in plus monotherapy ublituximab compared relapsed/refractory of to with CLL. high-risk trial Phase

for over the including be approval therapy. discussed previously currently this successful venetoclax-based therapies, available demonstrating have the hurdles We filing benefit meaningful study believe for for will and all key

benefit be of regimen to in are filing. believe all the highlight on to continue a therapies, this included will risk-benefit such provide does benefits and we continuing which We BLA analysis, potential would and that available work meaningful our

our to along UNITY-NHL trial. Moving

the evaluating multifaceted relapse lymphoma of this - As is of marginal finally, umbralisib double with B-cell in enrolling currently which and marginal patients evaluating diffuse the cohort combinations current enrollment UX a relapsed/refractory and evaluating using triple is evaluating And relapsed/refractory lymphoma patients with phase lymphoma. arm a single-agent combination of follicular monotherapy, of a of umbralisib follicular plus lymphoma. zone variety monotherapy. enrolling The into UNITY-NHL towards into and, patients a includes we cohort is this the single different subtypes trial is of lymphoma, arm you with single third have UX completed cohort, arm into In large target also cohort the combination arm patients evaluating zone now UX this with has distinct bendamustine. enrolling across of recall, cohorts, non-Hodgkin's subtypes triplet lymphoma, The as program, umbralisib potentially, three combination building UX evaluating a backbone may trial which NHL. patients are a

cohorts. made enrollment have progress three diffuse zone of we approximately We the all and one X XX all Once month or file the follicular, of study complete, marginal to major enrollment to amend patients the in across protocol large of current enrollment subtypes, from for substantial open we only next and with new cohort so these phase B-cell, plan combinations believe three are we completing while to to cycles. away up

our review sclerosis let's multiple Next, program.

same presented mentioned thus, III not recently program the II trials. point Phase of ULTIMATE the Phase as at the we've ongoing As known the as if bit and believe, same Phase this II better, Phase the highly point our good, Phase believe data. is call, MS II data data time We - III at start supportive at this we every of than ocre updated

II we identical And of and enrollment of as complete our announced the is mid-September. III first and we quarter the enrollment Phase from target forms the a original trials, anticipating FDA, Assessment guidance both ULTIMATE ublituximab full completed trials by under studies this of into I As updated with Special for by are completion morning, are Protocol This relapsing to in two MS. running reminder, XXXX. evaluating we

in into following remaining over which potentially is of multiple data That opportunity launch right are $XXX to mid-XXXX. to don't and shortly quarter that, now the operator we session, and anti-CDXX approximately its monoclonal I to With well for after sure conference over major and program alone. per as this growing. current us, the a in I'm sclerosis as ahead So enrollment approved available remarks to to remarkably million $X provide look Currently, turn call for concluding Q&A ocrelizumab rate sales return only of year like as the schedule. begin full at I'd is completing fifth and and as milestones review XXXX. forward a will well of having early in we antibody the I for is obvious U.S. run a the billion that state need some our this the

Operator

[Operator Instructions].

Yatin Suneja question first is SunTrust. Our from from

Yatin Suneja

question a the Just on line. time

end terms follow-up So UNITY-CLL you tell I us between a you follow-up now the mean could by of announced And data happen database will have after maybe when summer, and have What median data data? the you, these where Mike, that. do of the or needs yet? locked be in then release? And to

Michael Weiss

the of for course. question, Yatin, Thanks

the of the I open up, terms I don't think or follow-up you mean I or can median in mean median follow-up. can the when we give follow-up. so give So you I think minimum

I'm decided XX for probably to have wait it's that at sure we So obvious point, this folks to the cycles.

No, on needs actual I of data, up minimum mean. now database between locked X that have get or a all database What but of locked for The don't it happen guess, in guess, part XX approximately know now the XX we'll it's another yet? think, at to of X the median the matter from, we weeks. the once median to cycles probably I and few be It's is XX patients. to the the weeks happens. because sure, should probably when months a release? basically, question, So follow XX only plus think, days, of - to of that I or your months, least, is a minimum us next have the I I

you was Good tricked So a work. if the question, question trick me.

behind fact we sure do need this working PFS that But also thing in is day the the have - I to the big a coming then put or everything team, cleaning - goal that we cautious. probably mindful get of together. making mean, think, be to I know we're there's their all but need yes, two. And we next this. up make big team not data, to we the are out, hard, to it's Statisticians we some again, perfectly. a just information be So preparations

and and So again, ops our statistician statisticians our the cleaning teams are The are stuff. folks clinical working hard. team of consultants

hard quickly me want what don't is can. So you I hear to But working to next everyone as know they it on point. else as get from done

Yatin Suneja

is Okay. obviously, mentioned is - the big endpoint. primary This is PFS. Then mean, important the helpful. I that there you an

use timing the you're obviously, could we So accelerated expect endpoint. ORR approval that mean, an as help us endpoint. understand when or I going to

talk the obviously, of also and, regarding importance about help us maybe timing? So PFS the

Michael Weiss

Yes.

in again, when the So PFS of terms is, the distribution in normal guess [indiscernible] a best said occur. little talent bit more We've that guess of XXXX, to and over a today vague will a our past sort just - it maybe to 'XX that as put happen. 'XX. I could end is what talent before, rough said a the curve little a of of that's But

at or think of I think as when the even ASH the profile event goal occur. frame the maybe that time enough information maybe a better on end rates year of into create get we'll JPMorgan, we to will towards we is our or have

Yatin Suneja

final And then Okay. question. maybe just one

Sean. Moving have one these on the newly then updates how we quick talk particularly you bispecific. you about of a are acquired CDXX/XX interesting more very thinking to for on or these you Could pipeline, clinical programs? prioritizing some the asset? asset, one on expect can And When perhaps

just can share you the If is tell outstanding. us current what

Michael Weiss

to - we'll we'll one Do okay, you me on you. to second want go first that for get - Sean get

pipeline on of all products. terms we pushing as possible hard forward in assets, are as So prioritizing the

have to terms update, we've we of are, of some we about natural give too exactly. where where been not in are specific an got just So - we

bit our the color a little a getting PD-LX, give partners great job But done Checkpoint can you'd at like. if have I in a So us dose.

the So PD-LX. get getting expanding the to in so the can of up a work dose, did all to with and a they we're heme into basically running malignancies and process protocol we start

the it October/November say, happen, able a we'll so be frame. already dose, at is should we fixed which that start nice. But So let's to there, time have

than Our or shouldn't but well. weeks weeks month maybe getting BTK, that as away from hopefully, study possibly away, more two, we be started it a - are, we're

I Our cohorts treated, have of in China think, patients. partners already X or X

good some first dosing patients. our be getting to information them we're start So from to able

year, excited clinic that end just the before exciting, we of and so is CDXX/CDXX hard that's the as then get that So as Again, in, And would we're you awesome. about program can. pretty we the know, and pushing into as be can well. if the as we're

I think get versus become coming in of combination as probably pretty have obviously, we're through others laid profile have we industry. as do the and And that of several pipeline we heme of - out program then dosing the some trials our super for of soon to pivotal to are for. and that compound see the years, more excited quarter, signals next close is the around, a looking more pretty that get start dosing plan well about we and that designs and we realistically some first are but we trials clinical the

think quickly compounds. in some these things move into areas pretty with will of pivotal of I So trials these some

dosing, Again, So I'm stay that. think sorry, be with you developments. through have guys to we'll got I posted get able some for and exciting the hit to then we've forgotten. I

the take We have on Sean Power, shares question who will outstanding.

Sean Power

we just have under million So XX currently outstanding.

Operator

Matt from is from Ladenburg question next Thalmann. Kaplan Our

Matthew Kaplan

in ahead MS enrollment the schedule. of well completing study on Congrats the

Michael Weiss

pretty obviously. excited about Really you. that, Thank and appreciate it, we're

Matthew Kaplan

the are about that thinking. Can staying on guess, [indiscernible] in view, second well? what quarter little a you from first what has you of ocrelizumab the Just talk Help commercial and bit of a seeing the done I bit. the little a point on us there MS year half as opportunity

Michael Weiss

Yes.

data impressive, is to thing ramp say So I'm ocre say the to the the and is first is, least. going wow,

that it better MS. a think just for I treatment shows options in you demand there's

I I data the the in launch. think ever CDXXs think some that's of that's produced, and demonstrated best represent been

think opportunity. So billion run rate a and growing. huge a it's obviously, $X we They're at

by billion into. So hit for market $X the jump knows, $X who market, we opportunity billion, us to the time

really nice product profile think, a have developing we We is that, here.

infusion, not We in remarks, certainly, the certainly activity as it's we well. patient, I - is II data II ocre, the have prepared in a for compare Phase compete of point quite infusion terms for And it we're I which, doing level, optically, across our is tie but said think, my suite. the great can't great if to trial, Phase of the Obviously, data good, we as similar better. one-hour

So one I I we nice, U.S. highly been going a I a share. price We think that know U.S., a think in And really trade is has can ex here will our with using for certainly in changing there we - us, very has a are to tone, to changing think the to we compound, should there we're have we dosing do is efficacious schedule. what we share been And that there gain No market tone can be pretty convenient And certainly advantage. and price and market aggressive. room. we aggressive think for long pricing, then

it's quite market. really if put going say think billion So But a again, we But are we amazing. and it which profile, exactly $X this really we're who package, push do is a very be. mean, I we're hard And point, price well. XX% do think a in knows, nice to well we we to Asian together I to knows, even and a where I will XX% for expecting of who with hard very we and base, nice off if great working can think hoping

Matthew Kaplan

you're well, for things the the an UNITY-CLL with and near as objective the of over cards progress helpful. rest That's rate what update on commercialization there I the as preparation term forward? the making you you're on us And pipeline can turning and guess, give response for for then, move your doing

Michael Weiss

Yes.

chief step commercial the in we took we officer. and So big brought a forward

first working is plan. So Adam his good together step - step. that's hard, a commercial putting

who allowed to is, in and Adam road, will yet, to the we'll think is bring in now, to folks order, introduce build But folks. space let's that, I too him call. he'll short about - idea plans and got I've it place, his and for other hopefully, talk think. give get I'll So really a one-on-one him now. to we'll much him But him say this little the the have plan. to more meetings talk about, I to enough that can't his ask and you on not out told me whomever say to they're right and give in than a we'll out him listening I chance I've on

Matthew Kaplan

good. then Sounds And last question.

the and into digging data there more sense detail Can follicular bit timing Just readouts? a little the in UNITY-NHL give marginal for and zone us lymphoma, DLBCL. in terms more programs - you a a potential of

Michael Weiss

Yes.

that to So patients so we'll and between from nine is our for data. cycles, enrollment somewhere expectation completion follow XX of

year. be we nine much the go So I of next we're it's these first but exactly we've all be is on certainly, we middle half think, - If pretty it's of where should tracking, programs. the where - sort update year cycles, been think again, of XX depends. I of which if we half first time, within But into next it the half. middle-ish, first year it'll handling for cycles mean, really will

Matthew Kaplan

roll all once? at they sequentially or kind do And out of it is

Michael Weiss

guess, XXX% They'll Certainly, sure. together. the marginal up together. I'm I being probably a zone of out chance and have end not follicular reading closer

we'll things DSMB. happen at do - So it through - these and a proper will the

possibly And guess, formally expectation Diffuse so that to large response about because is going time. and shorter need the potentially of I think and we follow-up analyzed they'll to different, timing I you're be have needing shorter B-cell, of durations slightly think the together. is

little guess, think but to about, a to one got think of bit need through. we I a one So bit more little we've I that time that fairly think

Operator

Raymond is Benjamin from James. Our Ren question next from

Reni Benjamin

first release, press Mike, file BLA. can in you I help potential just me you to the company's mentioned the understand know -

that of GENUINE be would in mean as be of to which UNITY this me think is running is work? you of unfolding? remarks, still that included terms GENUINE mentioned like likely that or How do you filing, - by it or filed or now submitted. the the of makes being the that think any Does BLA in right itself. the to kind part that Has NDA out first I in be prepared part of is see

Michael Weiss

Yes.

So I don't think we the we're past. point any at different than were in

changed data, we're - will one and has that we or as whether our is out I options. UNITY-CLL one [indiscernible]. together think they which first or see we think on I or go still GENUINE second don't the one nothing in Until doesn't there of can make decisions any go one be

I time. need need some what for which been think more we've we we saying quite is to information, -

So that. no change to

Reni Benjamin

late Okay. you Can six cycles - And UNITY, that you're the I that prior mentioned expect XX because, within just give I wrong? us control can waiting wait sense have many studies recorded give us responders. arm would most data UX much, for you for responders from some maybe the wouldn't late just remembering cycles' you've have for thought I'm the data decided you're you XX months. would in to that for might assuming see? but the you that worth I'm arm, expecting how a sense been responses a then when for of

Michael Weiss

Yes.

is, overall cycles of the honestly, enhancing the about response. leading additional not So purpose

no that to potential monumental And X overall as I a XX waiting of cycles. I think from secondary result shift that's correct one recollection expect think a is would benefit. response data of in a your the

more I duration response, term XX for us information think on more information gets what it cycles of follow-up gets longer is safety. safety, us on

a I those more responders. that, would it. maybe a a yes, handful benefit, have late probably would even we to So be of tertiary reason the are secondary Like do said, of benefit I not expect to a more think of onset

don't it's to going So worse I going get longer. think

points. said, think I few percentage a tertiary like pick up will benefit, they probably So extra I

Reni Benjamin

Got it.

an U.S. franchise? franchise, development then I And the final the for kind just not you thinking ex MS be one talked about this one have but strategy do also do past, that of you for of but what business the you Okay. CLL just about? we've think in have, And don't me. sort thoughts might for

Michael Weiss

Yes.

head Waldman was the So global Adam Celgene. marketing of for

So got global as know that. thoughts team, some he's or global well of part he's the I on

he's got as well. He's thoughts. So some into looking strategy that

he we'll And on So we want work. to to marketplace, gets think let we as for And about at make him goes of MS that it. how both sense need ex that I feels approach He's a U.S. decision once how he this same probably a the time. exploring sides of think do his I well.

Operator

Kumar from Our Madhu is from question next Riley. B.

Madhu Kumar

considering the sclerosis, in is multiple trial about quickly plan a Thinking recruited, how trials in relapsing primary I disease? mean, for mind a there progressive

Michael Weiss

plan. a is there So

large at Let's plan, progressive. to so look say, it's a Phase at plan [Technical think moment I a fully vetted Difficulty] primary III. don't at the we'll looking be

of Phase to perhaps or we'd some II possibly - in start to comparison study, with probably ocre. sort like think I

out don't in do running - not trial a I So primary large to progressive. we're Phase III

wasn't the was, size at statistically trial. small think power to of you a And was remember it was an significant for it data, I - marginal at we and I I don't exactly it what that, larger even but would - if a the marginally or of ocre look X.XX the We it the trial. p value size study. And would think need with something.

head-to-head the appetite be progressive a of in interesting. I we minute, to have each more do I moderately could fashion other patients comparison II that in sized primary drugs two don't the this Phase a think but So think

it's let's do, say it's that not for going to So plans our tomorrow preliminary but that's sure. on to and start

little we bit before wait to that going going. we're get think I a

Madhu Kumar

the has that filing SPA accelerated rate UNITY-CLL, for for Sure. And that support on guidance under NDA objective explicit approval? response remind then can and BLA you a us given FDA an would success

Michael Weiss

restate question? You a that little broke Can up him you just bit.

Madhu Kumar

Right.

the the for FDA said support - So is umbralisib? NDA ublituximab for FDA UNITY-CLL, under filing the on objective explicitly has response success to that and BLA SPA and sufficient a

Michael Weiss

Yes.

at really care is anyone. FDA circumstance application, Full that any and in can function say available you can a the you that. the Accelerated So time SPA around to always the approval, can. never of the approval never of

trial, part arm, and approval, you pieces an holds. plan overall in the needs - the discussed approval in response too that the anyone all and any in and anything full it. SPA kinds therapy lock under of was course, FDA can prove are these always would you SPA standard separate of that I if So the over regime, the But that control goes accelerated they don't the to circumstance lock available regulatory to But context a the with discussed provide of lock approval meaningful as to the you pieces. in so get under possibility of to and as process filing much Certainly, lives us. of accelerated stat GENUINE apply can we've think a benefit that because for of

Operator

Andrews is from Our question next Matthew Jefferies. from

Matthew Andrews

Mike, wanted could I you clear what that. NHL? on to just repeat the you enrollment be said update on

Michael Weiss

Yes.

we enrolling but are, been for of into is, to single It's So we we in follicular of lymphoma that what step. the just set, of I cell, number weeks. in coming the - single to about in the believe be where we've we single-agent umbralisib. target plus And should the the we've move the enrollment so we enrolling enrolling current call zone, terms into B UX hopefully, In once completing keep - in patients completing we're been each we've single next bendamustine. arm on those a in of umbralisib. arm finish of large arm said a marginal cohorts. tried categories, right been into And in diffuse single-agent between, what break now I in one of the just enrollment current We've a

Matthew Andrews

And B-cell, a while doublet the ago, for then the closed enrollment right? diffuse the

Michael Weiss

UX alone. Yes,

Matthew Andrews

Got it.

it, III, showed rate a its a was Phase response a XX% appreciating the a have question number study I'm study chemo is July, I paper the the real-world suggests And combo blended. there was agents - well relapsed/refractory a as IIIb drug this on - as obinutuzumab other early of GREEN The XX, is real-world own. plus true published XX% which on ORR the frontline study, not Phase versus sorry, in within and of

question are true on powered, a translates to is cetera, UX trying to So is XX% a arm show for is, way that to how et the stat sig the if XX% UNITY-CLL show to the arm? difference, comfortable you'd XX% my into based in XX% benefit you and shows control study this able and

Michael Weiss

much Yes. in mean, comes with have I XX%, I it I deck. pretty to here. we've XX% is if have in, blended mind my XX% I corporate what XX%, think mean, been saying we in what in line

we wouldn't on what well So that of have were if on could true can the And I certainly that. our within think happen. be we win reason yes, to result. certainly, that predictions win I

Operator

there if for to are And comments. further back the Instructions]. no [Operator to any closing over questions, Weiss Mr. like turn I'd floor

Michael Weiss

And I'm just by very key remainder the thanks - objectives you call Thank much. briefly reviewing also again, goals the this and to Sure. going up wrap the of for year.

response we've data present UNITY the the As for to discussed, Phase overall CLL we plan III trial. rate

presenting clinical ublituximab we're II to medical the from cohorts. We're NDA. first at Phase this the trial, company's and end trial B-cell for We the expecting And in data potential to follicular meeting and major larger marginal for a updated a UNITY-NHL are plan MS current the zone in BLA filing of continuing arms later and/or from the including our and of complete diffuse looking of of ongoing for forward to our enrollment prepare trials year. results for year oncology

our everyone So evening. certainly of on continued a in well for of as here thanking investigators at their again, great shareholders participation behalf TG, trials all for us. their patients of for all want to and Have Thanks, joining us our as thank their support. our

Operator

This concludes teleconference. today's

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

TG Therapeutics (TGTX) 7 Aug 182018 Q2 Earnings call transcript