TGTX - Earnings call transcript Q2 2020

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

Operator

Hello and welcome to the TG Therapeutics second quarter 2020 earnings conference call. At this time, all participants are in a listen-only mode. If anyone should require operator assistance during the conference, please press star, zero on your telephone keypad. A question and answer session will follow the formal presentation.

As a reminder, this conference is being recorded. pleasure Vice the President, my Jenna over now Senior Bosco, Corporate is to call turn to It Communications. Please go ahead.

Jenna Bosco

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

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

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

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

Sean Power

you joining and Jenna, everyone thanks us. Thank for

combination begin with of results through may raising the I’ll have our quarter, can our $XXX to during the on We were more this Media facility were XXXX. and following line investment to positive section XX our the morning you position. cash released our believe $XXX.X funded results. equivalents than million, of our As X Accordingly, through UNITY-CLL happy our Investors use operations had and of aware, financial we top leaves June bolstered be which securities us at sheet offering website. viewed and be balance the cash million public ATM cash, support and the of Phase our we well

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

$XX.X loss six $XX.X items was $XXX or approximately Our a the to excluding June ended June million. of XXXX. share six net for million compared loss for share non-cash months months XX, per million six June $X.XX or net The ended was GAAP the net ended loss XXXX months for $X.XX XX, the XX, XXXX per

which R&D commercial wind Weiss, the continue we costs turn partially our our prepare decline expect I CEO. Chairman costs to For call pivotal for to we the Executive remainder to and Mike our ourselves programs G&A now With as over will a of by continue down, in increase XXXX, first our will that, as modest offset be launch. to

Michael Weiss

and UNITY-NHL ultimate TG and things us from expecting of and everyone XXXX from It’s and detailed thanks present for results and the second will announce for results first exciting Great, studies. MS this a thanks thanks Sean half morning. our amazing we’re truly been Jenna, for our where half studies UNITY-CLL joining we

integrated fully a from we move XXXX, approval to first into development could propelling forward our a us organization. we commercial stage receive As company

umbralisib the start for submission with application by treatment of year’s single team’s highlighting was patients call new a first preparing achievement agent submission our We our the drug of effort and for I rolling company some previously and me accomplishments. follicular Let in major completed of circumstances. This under in our commend treated marginal lymphoma lymphoma. incredible this an such this zone challenging

the X of P-value that previously announced improved met also with a We free in trial CLL UNITY-CLL primary naïve of combination than evaluating UX X.XXXX. treatment progression endpoint patients treated survival and Phase both less the

Cancer Center our million University leadership Medicine Center. Dr. strengthened balance ATM as new from University Scientific Officer. to Center our of Medical Lymphoid sheet us We offering the Development from Irving as our the O’Connor capital and Columbia the He Professor facility. Sean Owen he largest the as where served Herbert use mentioned, As with with Comprehensive date well Center medical $XXX well team most public of of Medical our and and in we our Columbia Program and for of as scientific the Director recently Experimental the Malignancy bolstered joins over as addition at Lymphoid Therapeutics as Director Malignancies, co-Program and of Chief

Medicine, Sagar Chief Officer to at is well Emory of Winship and Chair Professor Emory as as Medical of the added and and Cancer as Medical Dr. board serving also of the our Lonial of Oncology Department Institute currently We Lonial the University School University. directors. Hematology Dr. of

team building launching they progress and work great and been launch affairs have already very our the is plans. oncology medical deep in at products organizations. This space advancing our We with made hard have impressive hematology also experience commercial

WA Phase the presented we investigational addition response and highly Director Chan data BTK Center rate, and minimal undetectable Clinical the safety Hospital disease We of the Lymphoma Hematology Lead multiple Sharman, of to ublituximab Dr. as of Research as at Lymphoma Medical demonstrated have U.S. Sir improved EHA, Oncology, data inhibitor, Jeff increased Director our of combination ASCO monotherapy alone. survival, ibrutinib the at Excellence that progression-free the selective significantly to trial the rate, this TG-XXXX and At Gairdner rates ibrutinib Dr. efficacy publications by a also at residual Research response year, in and final which the Charles for presentations had with of compared presented Cheah, including UX. and GENUINE preliminary from overall already results X complete

about year to next especially data in with are the We initiation of forward year. and XXXX this this later excited combination further with look and compound combination UX additional trials

umbralisib Pinilla data of Dr. Javier Cancer Advances, the effects Institute Moffitt recently Blood Hematology. unique and journal of the and in immunomodulatory describing American Finally published the H. Research Lee at Society team of a preclinical Center the

for As I mentioned, it’s TG. an first half exciting been

status reach. our provide of and turn to programs overview a let me Now pivotal and high level update

program. the with UNITY-NHL start Let’s

submission the monotherapy As the have response is as marginal disease multi-faceted trial treated UX a This evaluating those rolling met a with previously in evaluating program a or completed monotherapy lymphoma NDA in overall us The to umbralisib as umbralisib quick UNITY-NHL a in reminder, huge well zone lymphoma need. on to is cohorts. June. patients endpoints bringing we cohorts step of Based rate. results, major the a combination variety their our umbralisib combinations, primary and forward patients to including FDA of for milestone follicular

breakthrough zone lymphoma. therapy As marginal designation patients with a umbralisib for reminder, received

to Next UNITY-CLL I’d trial. like discuss the

assessed This and clinical study lymphocytic conducted combination versus UNITY-CLL plus In obinutuzumab as trial trial or in the less at of early demonstrating As of special CDXX trial a leukemia. chemotherapy statistically is chlorambucil protocol in the under by we P-value review the announced a with relapsed the assessment of the UX is refractory in the global pre-specified X a met chronic reminder, being analysis May, X.XXXX, treatment-naïve than significant primary committee. UNITY-CLL improvement Phase with a randomized patients FDA. the interim endpoint a PFS independent

believe may XX% potential be to pleased who approved, from treatment the the patient or they prior were the untreated, was benefit patients, combination and are the and trial You with to previously for recall XX% relapsed enrolled If or option that be note an that naïve therapy, patients observed we populations. across both can referred UX as approximately refractory treatment to important has CLL. PFS we

trial me in forward a year data pleased of study sclerosis. our by BLA but We program with look certainly let review with Last end multiple NDA to are outcome extremely least, and presenting from the follow. to this ULTIMATE not the submission

earlier ublituximab ULTIMATE special comparing full patients months trials offering approved is of from We annualized study line being X be for billion. and targeting quarter. as minor MS. still currently $X fourth of forms we paradigm. which COVID, are is global in submission physicians in a two ublituximab in reminder, independent with that price. one-hour multi-center a following to trials we to infusion the in more have only of are for conducted relapsing enrolled the assessment usage to the six the support the a CDXX utilize rate of should attractive releasing MS global XXXX and pleased will approval ublituximab X in delays sales Phase at every to protocol trials data oral in are designed one CDXX to there the convenience with approved, Despite If studies class some tracking competitive FDA. continue we is option of CDXX believe our top of market, weeks from each and for endpoint under report X grow are forms both treatment is excess relapsing treatment an believe As fully relapse Currently teriflunomide. MS, randomized MS quick XX primary The treatment These

pivotal we’ve lymphoma. operator return BLA I well, back marginal like all how forward begin some six despite to new product, treatment the team’s the very achieve the and data where data power from We to the targeting which, the With of challenges and the say concluding BLA UNITY-CLL, zone we’re if to remarks. are in program in turn far call following with a submission we XXXX umbralisib I’d continue I I NDA CLL are exciting through launching the to and in submission and first have the and this will conference we for both looking our make to progress months from if extremely made which over pleased to Phase for Q&A lead lymphoma clinical UNITY-NHL positive, X COVID and, and for environment, XX set to thus in all our am a follicular next year, all combination ambitious that, session, the have ability with goes ourselves MS to ublituximab, this presentations to to UX will ULTIMATE impressed milestones

Operator

from Our question coming is Young instructions] [Operator from first Oppenheimer. today Alethia

live. Your now line is

Unknown Analyst

Hi, thanks. It’s on the [indiscernible] on for progress all this quarter. Alicia. Congratulations

know on update to of follow-up, study the numbers of the with in there’s to As wanted then past earlier I the sort venetoclax can some talking clear and about ASH, [indiscernible] then just patients excited of you a the about terms give we up. from update and for see one getting who might on also combination if gotten get us any closer shaping - of adding get in to sense we ULTRA-V studies of response there’s that in and and the guys you haven’t are how patients just that’s think and UX, were I

Michael Weiss

I at even least XX, numbers Sure, terms in the have of so patients XX completed ASH by I the more hope we’d ULTRA-V, XX, actually but treatment. maybe exact few don’t of somewhere would a in who have have months of order

think patients, UX, is XX, the that’s be is just will ULTRA-V, presented ULTRA-V. later. me order start It’s on trial, or combination let referring XX-ish until of let that somewhere complete guess, coming take I X to, be me plus so patients--sorry, from I’m X back. venetoclax and our over. not This there of what until, Phase Phase will the not the XX I

this at venetoclax. that’s have on around call So XX mark, efficacy In that’s XX-month we with months to include, of like Phase year combination so plus later XX presented presentations should and venetoclax, XX information again so ASH, XX will preliminary the said, UX of stand completed patients, and prior there XX update safety we of Phase X patients we should where who let’s and to UX will I that have previously some data the the on plus presented X hopefully it to total, treatment. be what include

expected the you mentioned we It’s venetoclax smaller BTK in of study BTK is added UX patients or agent single achieved one other and we for or who The trial. negative than It’s and months have only a on have study. not have where been don’t centers. MRD or on two in a CR, have study or update an any that six greater top on venetoclax

Unknown Analyst

Thank you.

Michael Weiss

problem, No thank you.

Operator

Thank next from The today you. Evercore from question coming ISI. Josh is Schimmer

is live. now Your line

Josh Schimmer

assets, team, commercial reps a your provide you Could portfolio given on relevant as their the of detail questions. many building more a of and the [indiscernible] little out how taking you’ll need? for regimens can there? tumors bit and follicular a full have cadence experience, Thanks best-in-class your Then well you’ve as timing sight, been development strategy Thanks. there liquid little you CL other about so, and or solid if focused lymphomas. for bit on creating CLL and you your Are in talk which

Michael Weiss

Josh. thanks Sure,

not road with positions In terms can which But road but give at on do been in chat lymphoma. lymphomas last U.S. we opportunities depth. Outside exploratory, and have team, certainly our leukemia, Then we largest our Waldman road franchise large zone commercial months--well, or but or and you nicely. the and early ranks in detail have lymphoma, from and a who I’d position, teams want that, of that, operations, have areas, them more it of B of the his the team. of hopefully is let details are, put the the on and the below I’d together the for say sales, how access, head He’s be areas we the know head have at he primarily heads hematology to together. remarkable of a on notion mantle chronic UX the some is it’s if commercialization brought functional headed the commercialization at get market Celgene. next lymphocytic a portfolio. but marginal soon I been and has the we coming medical cell of on in including Celgene will obviously in that’s team, coming now the of up Bristol so we follicular focus but lymphoma a have we’ll in went different several Adam other point than pretty for either a are want going we and lots all we point, in he obviously whether push with core say, mean, from those we’ll or or obviously together affairs, commercial eventually, Adam and announce indolent and just you We detail, cell other leadership more more team leukemia much have is of so then know. me studies don’t able terms diffuse into possible--I the really on whole exploratory head that areas Celgene in pieces virtually of has more some up

close looking excited much. in cell, bi-specific be indolent used our antibody as there, we’re we’ll anti-CDXX/CDXX there’s mantle in well and We’re could inhibitors in sticking diffuse that about and early think docket, B as opportunity PDLX diseases, lymphomas cell large well, we’ll forward. obviously combination pretty our We but cell covering. large an as certainly know currently B some portfolio our move to diffuse cell the that again future work terms for something we on BTK so we’re certainly possible mantle too in the large the so of as in the in Again, It’s that agents at more aggressive of B exploring indolent be some cell work as be to and we mantle that’s of diffuse B with cell disease say to potential. too core cells

Josh Schimmer

Maybe a can. couple of specific follow-ups, if I

to myelofibrosis of shown some the PIX you’ll be prior those inhibitors hire myeloma. Are terms screen launching reps large additional some approval with or subsequent, number kinase well? In on of radar indications indications, then effect or either to your you on them whether of in sales as and have like expect and other

Michael Weiss

second sales question go take to the then forget I’ll I’ll it, before sizing. first and the so force I back Yes,

pieces other on we a In do for terms Dr. and start come we of there to recognized myeloma are same, place at about myeloma, with think is in myeloma too a expert that multiple obviously and will Celgene, but us opportunity market I have familiar got Adam haven’t the the myeloma, to very think if pretty some exploration least we who and done much multiple yet have of in that. board, over of good we’ve Lonial some so is from an the the folks do in

presented compelling myelofibrosis, of already more interesting we of with terms data in. in combination umbralisib pretty ruxolitinib we��ve myelofibrosis, an some a so In area that and taking in serious interest that’s are

We’re starting to explore seriously. that somewhat

to an been we have soon, so that inhibitor clinic soon presented other could is the There’s do The as we opportunity. ready be enter that there’s part that’s data that’s ruxolitinib that argue combination in inhibitor our BET is nicely our there, together, as that started some putting BET has BET with combination thinking where a can as worked of the as would that BET would I about do we we’re in very possibility think note get something of which data a with I ruxolitinib. data ruxolitinib is three and just the term. be the presented, we’re but good PFXK, been about, in excited combination in near could umbralisib is with relatively all our

launch. take of staged launch follicular-marginal approximate with grow XX It’s half follicular, haven’t would kind so launch force sales that because size want probably the for grow the sizing, by that a and then plan is to that zone think the terms is the of our launch XX-ish we a sales and this general just as our time force approach. team, I full have and at itself, CLL is In we sizing to of then the marginal of time we’d expect of completed place studies, sales in at idea force CLL to the but sales on the probably we launch, to I give the think or and

range advance first, PDUFA as XX, minus the each so in be to the won’t of--we not--don’t those terms I give Like is force people wait me said, the will probably some coming Those sales on until be like but so, not months over five more hire of lock color it Adam in said, XX complete. of. sizing or those date. wait call or we are In in, exercise in plus will the It will after numbers, or could or XX or the board and those the approval. are numbers of I

Josh Schimmer

for very the Okay, much thanks color.

Operator

Thank you.

Our next Ed HC White question is coming today from Wainwright. from

now Your live. line is

Ed White

for morning, taking questions. my Good thanks

Just you maybe is be. your couple, going you be to umbralisib if convincing review be to your issues going could efficacy? the a think Just to challenge it others or that there. you’re pushback you Thank if on it going how right to then launching to sure lastly, what in be can or class, the them if I’m biggest I better and seeing going than European is you’re just tolerability you’re Is with that, now, conversations discuss you. also any to strategy. payors approaching Then having coverage

Michael Weiss

on Yes, I’m the going go reverse questions. chron to

to don’t strategy, we’re out any trying that figure I still there. European have updates So so

partner you makes Give to information studying can for to give go I it are quarter whether in think a the or I little and sense more today. we’ll best me perhaps. We and another us it Europe, is TBD alone offer

which number of expect was payors, don’t we to have any two payor question, issues. terms In the

community to I like so just we’re we’ve to my there best options, that completely drug a is do, five a sure--you Once don’t on is we’re consumer feel to one what’s the contrast in different melt I’m the very we umbralisib marketplace. my generation, to in which folks vast getting there just folks on again some and for a marginal I experience but the cancer patients, challenge kind question, - to one open expect relatively greatest with first perfect folks. we’re feel important experience. the seeing the show There’s the have to drug, Then barriers. think better and some who sins We done It’s coverage. value of they all once them educated right who they’re different not negative drugs but that payor pushback questions, our a them Look folks who of to is oncologists I be treatment will molecule follicular. going many our had to any majority see proposition vast just to relatively some - notice Typically the and in engagement be too begun. where novel reverse, was going knowledge understand challenge bad try most that of their is exercise, make consumer. out and The impression the the in inhibitors, generation PIXK personally to the To with we concerns to their greatest the and my much differences PIXK I’d our of commercializing that patients. lines need obviously--well, say immediately them off know, the and - question have profile vast, deltas. people biotech zone negative--remaining the has are don’t is it brings of not folks like payors. quickly. Then don’t try you get better that’s be, educating first the - number number to coverage, got fundamental and I’d good an majority too a are this lot We’ve to to will some and issues their front ad - between with let the going a say people compound be there’s see to umbralisib umbralisib. and just in knowledge have clear, a don’t the get see data head, but boards this been pushback engaging not me explain

community and get our participating oncologists have a a the that’s clinical going good in to is got studies, our place feel we’re try. already that leading--because so many like start. to obviously goal of compound We we’ve have folks who Our to trial used sites, been really had we

that sites Then going those to their sure very far they’re which so are each folks drug, engaged trial clinical the work to We’re of patients make interested positively. one back come with in a those umbralisib with than treating or co-investigators investigators those and clinical sites relationships has more participate in leveraging trial lot to so trial, partners their represents the to try in practice. who their also typically it’s the clinical in the get

start We’re feeling good obviously feeling great. in but use heard, CLL, position. much feel us sales and about people realistic and and can so that and I’ve Once From Again, into be we’re better the follicular people successful we getting with comfortable just of to those this what try the be it great to have zone indications, I’m more a to to quite what it. and think going marginal early try CLL make we’re are understand seen launch is education-education-education. by get not I’ve it, drug going well. one I in to really do getting I what so going of we biggest more it expectations get a in terms a indications, compound

Ed White

on thanks Maybe Great, just last a question Mike. XXXX.

have Can data what a to to we’re what see you. ASH. give at first of data hint going expect, at kind going we little ASH? Thank your us as can You’re to you

Michael Weiss

I’m big CDXX at bi-specific. where plus the venetoclax you I else, my so year. not check outside double what Yes, we’ll to not pivotal if UX--BTK our I’m CDX for from, are for guys. to talking we’re on XXXX. this and and of the presenting sure sure switch seeing presentations alone with ASH and UX but data you UX XXXX, ASH for I’m have that got presentations were plus focused sure be someone not to

stuff, think PDLX double I to have on terms of I’ll that, the we’ll [indiscernible], I’ll check. double In but wait of earlier some and check.

Ed White

Okay, Mike. thanks

Operator

Thank you.

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

line now is live. Your

Matt Kaplan

date to Hi, in the--when zone hear NDA PDUFA about about the a lymphoma. and for umbralisib wanted talk little guys. morning for marginal good should Mike, we follicular the bit

Michael Weiss

it’s will your complete. frame, time rolling us the a submission file for so what you to Obviously hear August the from would Typically that’s XX-day current a around regulations then expectation a them. or complete sure. day they issue expect I time XX submission accept Yes, or one back once mid-June, take it’s that’s frame, so was give say, a the two about guess around XX refusal days, XX-day so we’d either file, is or

Matt Kaplan

looking little path thoughts bit, pipeline forward bispecific Okay, wanted into development the regulatory antibody. for current dig to forward Then thank your and BTK a monoclone your you. or your for just at path anti-CDXX/XX your inhibitor

Operator

Perhaps on is phone your mute?

Matt Kaplan

Hello?

Michael Weiss

I’m sorry.

patients with plus mute. regulatory strategy, an Sorry phone XXXX. BTK is marginal then interest, Matt, one. the both a Yes, indications, patients is of of CLL of we’ve terms ibrutinib, UX somehow treated got so treated of In saying I what zone was lymphoma area for in is my UX great on with and number plus obviously those we’ve a number

basically BTK, it’s thus rate across of between think I far. CLL marginal both those plus think don’t--I zone, XXX% UX and indications I response

follicular something indications very larger BTK, UX BTKs it’s of for indicated trials confident be BTK about those to let’s could there across alone BTK top there where say UX. is interesting as plus UX be could There’s UX much indicated, we will won’t that. Now so - where indications. Then are but on opportunities be of going think be lymphoma, BTK lymphoma that, we activity registration course, down be that and mantle use interesting where ought cell is those both that’s but when excited so it is interesting, have high bring rates XXX%, we we potentially plus of and response can that are be to doesn’t

certainly to once did agent. both look follicular was with and we’ll look a and we with a but can. with point early, be that’s CDXX/CDXX, a at large some start way compound try at In CDXX, as in get diffuse Hopefully program. early that B it year, cell targeting quite next diffuse large so as we combine it’s interesting follicular that terms cell we’ll something earlier of would into B data too The competitive expanding

Matt Kaplan

progress. the a for and Thanks the taking on lot questions, congrats

Operator

you. Thank

from coming Roger Song is today question next Jefferies. Our from

Your line live. now is

Roger Song

my some you. so had and epigenetic ones. Good the morning, a Maybe obviously launch, we One will fit Thank recently two so few just approval umbralisib taking after Thank [indiscernible] what think quick and just have tazemetostat follicular, treatment thoughts thank and the is the [indiscernible], for positive we like sequence landscape. in readouts that. the noticed for you questions. developments future evolving I you. curious a quick evolving--given your follow-up will you the landscape

Michael Weiss

would pretty you’ve an as a Yes, that on hold up brought efficacy, so mild it’s high take two pretty modalities and treatment bispecifics. CAR high Roger. I option, side to starting good profile, then Sure, have safety Ts oral with other the got follicular, you in describe you so EZHX are and what very therapy a is which toxicity

I patients on aggressive drugs early at those benefit the bispecifics. potentially well umbralisib, believe, very if with it’s for on of we think or later agents, therapies amount a, are the generally typically you of level activity treat that safety look of of follicular lymphoma, the easiest with very lines nice and can the that like to using so you’ll maximum a of Ts into fits profile nice a these speaking want to handle and treatment earlier more get you out see CAR

best we’re They’re currently try it’s the giving your you light of later there for your think lines you to that’s the room of in few so time, on very period and in these sure handle, toxic longest less aggressive first for make patients. nicely quality going life therapy. something want for of therapies think easy the them them in across the fit these to I typically so I of not curable, for to but treatments line, therapies all early that is milder, more

I of CAR using settings, people some describe you start into salvage and you’ll think see get to as what once sort Ts bispecifics.

external In plus and will think more or UX a agent think than UX or other and agent. or efficacious over I’d agents try up PDLX, overall some be But That’s of a nice plus, I to point the tumor. could whether UX multiple be some standalone toxicity to we alone We’ve or layer time, therapies something still describe avoid UX combination, a as BTK CDXX plus UX to it’s and once EZHX, nuclear to umbralisib is it portfolio many, terms activity, regimen our again, very umbralisib efficacious chosen I interesting. to together toxicity as with we standalone our they’ll their always home think as certainly at is in to combination, find what highly has lower think low come even but that obviously plan. triangulate at a to been profile. use tried the we’ve maintains bombs goal

Roger Song

for, you for basically so have current BTK, color. interesting follow-up and onto is probably in Maybe other to multiple of just the other opportunity helpful. very portfolio? with CDXX, the it, mechanisms lay Got you have looking all alluded, [indiscernible] any mechanism [indiscernible] to some question tied you’re Thanks already want for my curious CDXX, action you

Michael Weiss

definitely in interested landscape We continuously B this area, always scan bring we that if If looking the think we’re trying sense. malignancies, there’s target it are that in for the I interested. of there in-house in validation targets makes treatment out has a to validated and cell

Roger Song

Got it, the you. for Thank Congrats. taking questions. thank you

Michael Weiss

Sure Roger, you. thank

Operator

you. Thank

placed the As to queue. be star, a one question into reminder, that’s

today coming question Mayank FBR. from Riley next Mamtani Our B. is from

Your line live. is now

Unknown Analyst

This strong morning. of good on for first Mayank. year. the half Hi, a really Congrats on is [indiscernible]

and couple a on a the sensing Could chance ULTIMATE hazard way that provide to then starting now on the on a questions had Are into have you’ve tracking a any us, additional analysis, for Just UNITY-CLL the the pivotal set? it certain programs. brief given revised from you you the follow-up dig I’ll of data programs. color interim ratio

Michael Weiss

too. at presentations this will answer additional this be soon. time. will be color any up The coming brief well don’t We have Yes,

wait I this think moment. that to we’re at going have to for just all

Unknown Analyst

Then kind last Thanks. patients follow-up then XX-week the into managed competitive some going be on the BTK analysis, thoughts side, might that Principia’s the understand of efficacy readouts as of also changes on product great. oral of maybe Any of Immunex’s wanted to well. recent going just how you your cohort COVID-XX. MS thinking Okay, and the and trial amid through their in

Michael Weiss

they think did some There time Yes, of were were impressed call, left XX-week mentioned, the XX% had on so terms and whatever the of conference into the visits. that on that of XX, for we our study last come their we patients relatively carried in COVID, stragglers, in conclusion terms I visits. as definitely forward fact and by in XX,

everything all, like just all will bit timeline most late, up about are impact been not the last most without or expected and What that the get and good. expect clean sites at are in Actually of heading sites the to that really a so something or all for the same, patients three the at things they’ve Again, three timeline. database, delays little the good--you we bit few timing the for the virtually, pretty not of the else the impact or trial first ended the got some much overall well visits time a have an final a about considered, getting one COVID. an conclusion so two, towards There’s that’s trial. none or little typical so overall darn to again, pretty come open much visit pretty weeks we fact doing Having point and potential in now. effect of my that is, the we affect data, to the given of think access stuff it’s or closeout second stragglers Europe not is that’s we’ve trial, of on clean doing is have two it’s a data, we’re good better really too so still talking so cleaning locked it maybe sites the I a affect that potentially They’re don’t in coming after in opinion, cleaning, two frame, should from know? a so don’t of that, said up weeks. one the of to right to could

of competitors compete the They’re that’s of compete interesting and are what tell think includes so in nearly oral they the in therapies heard the about the I’m underlying therapy, KOL multiple inhibitors viewed the These sclerosis, compounds, of are current multiple as efficacious will interactions we’ve all they these agents, we’ve us oral marketplace and levels. for world mechanistic the BTK developers CDXXs. but to not terms not had I that In sure, world BTKs. for their oral

too terms bunch impressive lot okay, spoke in in class its the out on a we with forgot the general came to power in of of KOLs spend which I not that spectacular from and opportunity that CDXX. to, was number competition data consensus KOL had compound with but out, the overly a Merck so folks perspective and data the a space, it’s it not we nothing that the first was the same came of of certainly time oral the of conference, The spoke a to

primary interesting MS, super oral maybe of In of B progressive terms probably forms competitor effect those again KOLs doing. complete what gets that’s trials, one BTK with relapsing blood-brain limited as active have the with that but barrier the but it’s not spending the patients some that molecule, at and is--like applications secondary forms CDXX gets of version of or we’re I overall in we’ll a in end barrier, concept the see it’s know, the of lot to practical a disease, compound of for the make crosses likelihood bunch blood-brain excited, forms. said, first going The it’s get crossing excited. hypothesis, to the progressive progressive which it’s of going relapsing is think clearly scientifically least the disease, to large a the that but blood-brain pharma a Again, active it’s of that barrier marginally have big in cells of blockade a vet in the money hypothesis a scientific the BTK application to material is some that clinical in to outcome and to effect the go-round some in miraculous then answer, clinical crossing may in BTK someone a is difference in otherwise, stories a was you really by is--you can

class competition like. in is the class. looks know Our what CDXX that We

We for play two in TG development market be We current know agents, and billion, going big plans. to a IV oral. a and marketplace, think very so a close to it’s to is expected CDXX alone to got and one future ublituximab. $XX role development You’ve opportunity and we’re one both on great which the I think plans have the nice for

Unknown Analyst

the second Great, taking really for that and questions, half. appreciate color. Thanks our to forward looking

Operator

you. Thank

of over session. floor the for to the and We to have or question closing back any Mike turn further comments. end reached like our answer I’d

Michael Weiss

again next goals like to and call our and remainder I’d once Sure, coming year. the you. for into year the reiterating thank objectives wrap this early by of

quarter, patients First, ULTIMATE the pivotal with we X Toward or line follicular We’ve like in shareholders also combination our have in well great us. at treatment zone next chronic I’d marginal regulatory treated in us so clinical amazing our potentially December the and for and as targeting continued the of of umbralisib as TG, our had therapy UX thank top support, presenting could everyone we year, data believe trials, our we’re many and investigators forms participating an of patients a in looking thanks for Have these of both time end the important from all with and well for to of for sclerosis for year lymphocytic their ongoing data for early trials. same and relapsing as their submissions far targeting the from triple joining are we’re the positioned previously programs around thus updated first forward are leukemia, employees Phase the lymphoma FDA behalf day. again as data UNITY-NHL milestones approval trials we come. We lymphoma. in well to impactful for success. from XXXX and On fourth multiple then to UNITY-CLL

Operator

Thank you. That does conclude today’s teleconference.

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

TG Therapeutics (TGTX) 10 Aug 202020 Q2 Earnings call transcript