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Aptose Biosciences (APTO)

Participants
Susan Pietropaolo SMP Communications, Inc.
William Rice Chairman, President and Chief Executive Officer
Rafael Bejar Senior Vice President and Chief Medical Officer
Gregory Chow Executive Vice President and Chief Financial Officer
Jotin Marango Senior Vice President and Chief Business Officer
Tyler Van Buren Piper Sandler & Co.
Gregory Renza RBC Capital Markets
Emily Bodnar Cantor Fitzgerald & Co.
John Newman Canaccord Genuity Corp.
Matthew Biegler Oppenheimer & Co. Inc.
Matthew Cross Alliance Global Partners
Soumit Roy JonesTrading Institutional Services, LLC
Call transcript
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Operator

Good afternoon. My name is Carmen, and I will be your conference operator today. I would like to welcome everyone to the Aptose Biosciences Conference Call for the Year-End and Fourth Quarter ended December 31, 2020. At this time, all participants are in a listen-only mode. After the speakers’ remarks, there will be a question-and-answer session. reminder, call a be As Instructions] this may conference recorded. [Operator like to would introduce I Ms. Pietropaolo. Susan ahead. go Please

Susan Pietropaolo

Thank afternoon, operational Carmen. XX, representative call year-end you, for Good fourth XXXX. to Biosciences the and Pietropaolo, discuss conference I Aptose Aptose am financial a ended Biosciences. and quarter results Susan the and for December welcome communications to

Financial Marango, Chow, William President and Chairman, Vice me the Executive President Chief and Joining Vice Rice, Business on Jotin and call Senior Dr. G. today Medical Officer; and and President Rafael Chief Mr. Officer. Senior Vice are Gregory Dr. Chief Dr. Officer; CEO; President Bejar,

Before call and laws. we that this will everyone include remind forward-looking Canadian securities the would proceed, U.S. like statements to of during certain statements made within I meaning

update CEO now Biosciences. as Dr. the Rice? events to are XX-K Aptose of that results, uncertainties, All SEC events stated Aptose's not please by and this they expressed. unknown set to reflect call about involve after and filings. risks statements of uncertainties, that undertakes recent actual materially during performance, to annual these and reflect report current are no on performance, it differ Form most To will statements the future learn could cause expectations. risk Chairman, those these Dr. Aptose's made. performance or regarding forward-looking as expectations differ revise date to call, assumptions date forth or materially and is circumstances turn the that Aptose President and the statements read factors from They made and from SEDAR results call possible only Rice, obligation risks, achievement of guarantees more required speak this and the Forward-looking and may in known law. I of except and actual over

William Rice

Today, XX, quarter Susan. welcome the I'd I everyone to fourth our December call and highlight several you, ended matters. want year-end XXXX. for Thank to like to

the want begin next delivering natural First, of that us evolution confidence to CG-XXX that give development. the I is the into express to stage of clinical signals Aptose

Rafael to Towards as leadership recruited sets Regulatory senior XX Medical Bejar, Melko, team. Affairs; named MD, this than Vice been have CMC Officer, and previously functions strengthened regulatory considerably brings and as additional our to George we years of now Manufacture newly for they of and at regulatory PhD, Chief Vice Aptose. our President skill we and years to experience Rob critical has more George vision, Rob our recruited position senior of Aptose PhD, CMC. and President expanding of or established a the leadership of and bring Chemistry, Killion, Control demonstrated time Pharm.D

their and I make Aptose of clinical have Chief we the beloved us, to to of company new of success. to decade. at closely the of this our Officer, the the last and Over in opportunity a likely partner Greg whom Vice worked certain all dear company. friend announced business in company, that his we time, pre-IPO to can to attracted is honor quality to the are who pleased You we the and And and talent worked of two evolution week. help candidates. achieve as read such experience this unique continued transform about are that press that to by resignation President Greg’s Executive Rob and closely today George leaving us biopharma last and a believe that of watch say, departure years, the Suffice is Greg next a are is company. pursue and welcoming him distributed biotech and am Mr. just and for Aptose maturation This are I stage together with as part we we aware the and this supportive grow all a and will time appropriate side-by-side better an a been we you release work level we Chow, they of a Greg Most of move. a to privilege we fully Greg. at with Aptose Aptose has it career exciting in and several I product respected career of with move for Financial

done Officer will can will Aptose, duties Going spend a to is do have Accounting all now them Well, other Officer much more announced. Financial Jotin time Officer Chief our and the discuss as Chief to forward, of until either these assume how permanent need I serve advancements. I CFO on Dr. Marango, for emphasizing we will and or Chief individuals while appraising move Business

to status. our wish financial I First, note

During drug runway our clinical our programs significantly cash us to drug XXXX, product to progress and our and conditions, to for able half manufacturing were financial the as expand market into position, result substance we of our us strengthen of CG-XXX. XXXX, appreciably allows accelerate which gives and a first

of Speaking let's generic its address CG-XXX, nomenclature.

the recap you scientific non-proprietary or This we Adopted luxeptinib for saw all it As will our name update. of in recently release USAN States CG-XXX. press a use and highlights the call, will luxeptinib for is future step drug and clinical programs a another references, the Council for will publications for more you look we of we our In the we status adopted materials, today's liberty United lux each likely take maturation back calling with and today, quick in Name, as of including general the the give of as to XXXX short. corporate

Looking around ASH updated around year. this data EHA expect later forward, quantitative present and know, June to as in we you

the with our one with MDS. other and be MYC on challenges trial luxeptinib, third today in in inhibitor, two leukemia, patients myeloid and qualitative or patients and in APTO-XXX, nature. trials, and for or many acute cancers; will in AML; COVID executed B-cell with the despite clinical our lux, And Also, with any patients more inhibitor AML three so our the studies Aptose updates kinase people with presented so businesses,

I for Bejar, luxeptinib. activities to of Officer Now our our Rafael clinical Dr. ask Chief Raf? provide will recap Medical a

Rafael Bejar

you, Thank Bill.

data, steady-state first a tumor ongoing plasma dose tumor leading fourth and including pharmacologic indicators demonstrating in on in X presented pharmacokinetics XXX of trial evolution receiving of the lymphomas, daily. clinical chronic increased CLL completed are and early at reductions to over activity tolerated luxeptinib milligrams, SLL XXX malignancies, levels non-Hodgkin’s Progressive We lymphoma, dose lymphocytic micromolar NHL, or follicular and and XXX two as we increasing in different is such levels therapies. and pharmacologic with XXXX, patients our leukemia, and XXX target types, current clinical Phase exposure sustained above including who patients, in cohort well intolerant of I favorable and levels cycles. luxeptinib milligrams to twice milligrams, or which date, steady-state have that with or modest twice milligrams B-cell CLL and multiple trough in of During lux day XXX milligrams patients activity failed

during on of website. twice of summarized in subsequent milligrams You December patient, daily. who multiple highlighted on in year, reduction the That EHA around B-cell continues will dose escalation in seen for present details that And patients now has in past study from of and news to is experience size safety dose suppression posters the EHA placeholders trial XXX from and – has June. European we corporate continued this presenting earlier toxicities EHA, function began data. portion findings will dose-limiting seen dosing been of we we after based is we note has a the cohort. data presentation abstracts good the XXX therapeutic as at submitted forward XXX and include a cancer trends tumor bone reductions A were Association at their expanded scans. now concerning including have we majority to-date, our updated are concerning of to on consistent over these agent. milligrams others data no will these the we Of myelosuppression year or continued look importance, meeting with available data ASH drug-related of more and marrow cancer the recall the than to in patient the for time December. that milligram follicular B-cell The with Hematology And had submission this The that the lymphoma I

result at the safety patients newly of and milligram XXX the continuing to a tolerability enrolled level. As treat to-date, we dose are

For the are clinicaltrials.gov. more on that clinical B-cell specific information malignancy and sites trial visit enrolling please the patients,

I Phase only of we Now potential luxeptinib the luxeptinib on known clinical in Luxeptinib to allowed application giving were spectrum in and both potently initiate myeloid to broad in FDA therapeutic hematologic that the BTK malignancies. patients is with that AML. FLTX and us agent lymphoid And of across inhibits a discussion the a a AML. October, grateful the of trial

of despite many remain I of advances and will targeted of recent in the therapies, remains aware, As the sure for majority current a there relapse treatment venetoclax refractory tremendous patients midostaurin to including gilteritinib, am need unmet and new or therapies. are you AML,

in from It XXX well is milligram PDGFR-alpha, initiate to of kinases Syk activity, the clusters including signaling forms IA/b AML. only Phase safe, which operative avoids of might other dose achieving twice pathways. FDA reminder, CSFXR, milligram B-cell AML, inhibits FLTX, our suppresses which that with that exposure luxeptinib inhibited pathways wild-type levels not driver clinical without on dosing and benefit. in that daily mutant it activity to showed the trial off-target allowed the tolerated based are key contribute and was FLTX us a and level data dose RAS, STAT The also XXX As of a plasma toxicity ERK, AML phospho-FLTX a Akt, trial, in that BTK. oncogenic that select Yet drive

would drug, rapidly observed escalation, safety dose design including minimum of dose found additional if well at oncogenic inhibition to mutation, response escalate. multiple AML or Aptose after us FLTX, driver and BID dose the more on including to is in completed XXX AML As enrolled the study exposures no believe that activity, happy signals with who it and milligrams the level. ongoing also NHL to in level trial wild-type encouraging patients generally with and the that that dose has were level by lux as find to I At with with you prevent continue a to the patients apparent in inhibitory around three first and well of a dose activity marrow we’ve consistent anti-leukemic remains FLTX-ITD look or the our milligram that us patients escalation, reported, the assay dose of exposures we to patients. no milligram dose patient assay, am meaningful appropriate, as enroll BID XXX cohort, trends milligram further as allowing with as dose we lux initial well leading but the multiple than observed PIA trial we cycles forward to patients reporting a to allows to-date the BID, PK study trial, signals. Also plasma explore as escalated three-plus-three CLL data XXX The we safety EHA. and toxicity is kinases patients on with complete report XXX AML traditional we at both AML on tolerated has we

more on please are clinical sites patients, AML For trial information clinicaltrials.gov. visit the and recruiting that

move APTO-XXX. to Now we'll

under During tested patients. XXXX, and relapsed in a we in the clinical somewhat trial are trial APTO-XXX AML being Ia/b inhibitor MDS radar our refractory MYC or Phase progressed with

potential. we APTO-XXX, its are correct for we pathway determining While remain intrigued with still the development

As you for safe proliferation, inhibition development MYC know, have remains expression study driver of a MYC of has in mentioned pharmaceutical inhibitor including a to a interest and even demonstrated you XXXX transient sensitizes cancer cell of oncogene cancers. research the we tumors the chemotherapy that published before, treatment. hematologic industry. years of MYC MYC The a is major to may eluded Interestingly, to reduction in as cancer

to safety suggest remain our reported per potential review, broad today, escalated will were dose-related XXX continued dosing an and to MYC that of reported observe we dose activity. we ASH meter future exposure. tolerability Most and of activity including continue During valid the indicator we repression, milligrams then level importantly, anti-cancer continued square. fifth had observations These for

of We of three indicators are allowing activity tolerability dose trials. escalation, and candidates all APTO-XXX, both and pleased our are by ongoing both from of luxeptinib and such safety then

will forward are pharmacokinetic this higher at treat now EHA doses, we more and I and generating the Greg at who results over As look Greg? Mr. pharmacologic updates ASH the additional call Chow, that we we to data to year providing meetings will financial and review quarter. turn fourth year. for patients

Gregory Chow

in million XX, We everyone. ended and approximately cash compared cash, to September with afternoon, December XX, XXXX and million Thank million December XXXX at good XXXX. you, XX, $XX $XXX equivalents Raf, $XXX investments and at

During were $XX.X for attributable of administrative surrounding activities, general cash in activities to million operating the and we and increased and approximately quarter, use XXX luxeptinib which purposes.

the Moving were ended year. statement. and the expenses or $X were $X.X no December $XX.X $XX.X revenues income Research for XXXX. on fourth XX, for for had for million million million quarter quarter G&A million the and to quarter the development year. for quarter the the the the We and for expenses year

Our net found the loss $XX.X More $X.XX in SEDAR. on was EDGAR per be or $XX.X for the filings detailed quarter million our million share for and and information year. can

for years. the have Bill want and couple opportunity enjoyed on as to Before good my support I want turn the in thoroughly over personal past I of Aptose eight I times. to both add a Board Bill, especially at well it to note. over time thank things I as a the challenging

there think it is a company. when occasions considered are to leave I ideal two

promise The on develop team and best optics. which disperses, three and innovative cash pleasure Bill. the on at runway. strongly is one that Aptose is team drugs. years programs than for to strategy deliver dose believe out been is all to to first there leadership. I for to am and and Thank under Aptose all other ever operational not speaking to And position about in with is on trials the and has financial I and its confident when the Aptose with is patients a condition Jotin have of execute Thanks. And today growing saying therapies the a the company it currently and where company available everyone. the It's clinical I obvious continued that, I'll you, is acquired more is just very Raf’s been, of calls. remain Bill, when naturally escalating you it failed these two over this one turn this

William Rice

and All I'll right. line Greg. us, that Marango have everyone also Rafael much, Bejar. Dr. on with the Thank remind you so Jotin we Dr.

we As introduce feel a any for to you first Operator, open of free the question. the could question pose us. if call questions, please to

Operator

from Our you. comes Sandler. Buren Instructions] Thank Tyler question [Operator first Van with Piper

Tyler Van Buren

is study. and afternoon, I of the on couple. Good first CLL, best luck endeavor. guys. your Hey Greg, I a I in NHL guess have future get the one

experience XXX You dose patient follicular lymphoma XXX scans. reductions mentioned to subsequent that, on that that from escalate continued to

Or you. patient reduction after patient. blast that confirm I'm started ASH not those reductions? that is assuming Is to question could kind then maximum that it response want to complete general, exciting. trend new So we is indeed And count since that? had us it's is patient up reduction that has level? I the greater saw a you AML tumor even just very at a than can XX% that Thank kind the that understand down upwards of to state that. that of help from XX% in maximum you gone Maybe that at that the second ASH? qualitatively,

William Rice

for Hi, questions. Thanks the Tyler.

these Bejar then So questions Dr. if and wants to on in. I'll jump ask I'll he start

to to at follicular data happy will patient, and Dr. the absolute scans, with for tumor Regarding to will patient serial decreases to we add is qualitatively size what may we're very are described lymphoma continued seeing Bejar biopsies with EHA. we upon or that quantitative and describe patient, that provide serial moment, have a so – we the this what observe we now has continue that. In want in

clones to earlier did in saw blast. patient a blood complete that? you from are is response correct to add want because that AML we've that patient observed AML at This with their as off did they rise of go dramatic Regarding and because that in of reductions exposure had to XX% completely that very you patient different peripheral XX% we again, terms separate Those to patient, Bejar, that do begin was patient persistent blasts you down completely the Dr. indicated that level, the what are study. anything and happy seen. a our

Rafael Bejar

No.

two patients. assessment think an those accurate I that's of

Tyler Van Buren

the for questions. Great. taking Thanks

Operator

comes Renza RBC Our question Gregory next Capital Markets. from with

Gregory Renza

to and your Bill Hey, future And team to Bill, congratulations are approach all the just progress, Greg, questions the the wish I today. thanks guys. I'm on curious, the endeavors, and you, in characterizing on CR qualitative for and follow-up you're taking to just all you certainly, disclosing and the best what findings your respecting today. that AML

last throwing the what just expectations some be B-cell fits and which quantitative on trial. at my as context on how dose ability upward disclosure, the the could patients And actually as set as your could then level, up dose occurred some activity AML you have then, to perhaps trial and to you here. on if it you you're I'm for could perhaps – those the Thank curious it Perhaps, you expectations Just to it the provide question. question if of data that type how well mid-year as around translates And well? very speed far just namely on for both the from perhaps activity the Bill, maybe teed think on taking you're this see of much expecting the that of in as perhaps, those seeing?

William Rice

a Greg. right. All Thanks, clot the That very was question, clever.

Okay.

with the as drug in these in B-cell of to the expectations would felt were truly expected in and patients. of studies we at levels. expected XXX what terms XXX out. higher that's recall dose concentrations dose at to somewhat starting borne responses We will it we also wanted We're you malignancy because see So AML, level. escalate. the luxeptinib seen malignancies not let's lower B-cell quite XXX with see that take the though We starting in And to And patients to patients levels are in sick. dose the we've step the back milligram time, dose initiated at that be continue milligram milligram, we we exposure because safe as to

dose. the we we recall each XXX patients. We chose inhibited lowest in transition clinical PIA felt pathways, And milligrams also Dr. felt because the appropriate that as AML. was to other trial, we would we watched it said, be FLTX through then we well that was the at You'll we as went What in tolerated. assay, AML to show dose safe, could that as that though Bejar dose and activity over

we've telling all we everybody XXX, that transitioned this So we been active. is into along and believed drug

that So that, these drug. truly is active data show today this drug an

And CR. show we've even that the so level, or seen level that at a dose we milligram we starting proven XXX dose have

Now case require are patient They'll milligram pathways additional some various be will for have will patients because that that operative. the every level other XXX not the at dose exposures.

as news they so in to for on And to we'll additional they've the continue it that escalate, leave on and big clinic. no safety had seen, this the this is But dose we and CR, data at patient. study, a hope seen we as signals we've the responses that see quantitative patient, continue we've

we that available patients of time, or on dose to at all that In Marango? level verified all to status, did every sourced add when data EHA patients in been on on get have Dr. Bejar, the effect, terms to available both mid-year, date. want to Dr. clinical all data that you we plan providing at

Rafael Bejar

Yes.

of goal drug you the a today as what to complete more at set said, disclosure information, the and picture EHA. of reiterate gather highlight we’ll out we we'll the the make Just to Bill, more that activity is

William Rice

to that anything Thank you. to one? add Marango Does have Dr.

Jotin Marango

Nothing No. Well add. Thank you. said, to Raf. yes,

William Rice

so right. All much, you. Greg. Thank Thanks

Gregory Renza

you. Thank

Operator

you. Thank

Young Cantor next Our from with Fitzgerald. question Alethia comes

Emily Bodnar

discuss that ASH and taking Emily Are Alethia. about previously hypertension, for wondering our the there was the of patient? updates one-off a related that on you Thank was then for you're was still next I said patient as you. you possibly Hi. at had study it of towards development This And any kind to that questions. is case plan on drug. kind Thanks maybe case? do a rest your possibly data? you the that believe Phase of getting And could I of

William Rice

right. All

address I'll So – those. thank you, Emily.

the So the XXX X had B-cell patient milligram that observed and is had trial we This bed a only we’ve they that, as patient feel the put we to been level. was though they on Grade drug, I completed at the on malignancy BID that think four dose hypertension, days.

time, is a that that quite finding. So remarkable at

that is new So data. what And something so of patient is raises this go to multiple lead back hypertension. done you the then been there had ibrutinib, onset cycles, take which can do your realized review of it cycles we prior antenna, your have on wrong? time, to When we've

even that actually already We drug, Upon drug. they Grade was day day patient four Two XXX. were ever already – drug. also know it what, they X They in our before they’re that that X. screening, before on on in and on this hypertension had and went Grade Grade our new do was, progressed onset, began new began had they they received ever weeks that X, Grade they two two hypertension morning, further they later, onset before developed that went onset. X days, The days our

So the new in hypertension. they already the aggressive onset had

that all in less in trial four-day on at because at that we three other the of all dose stage the levels exposure other six-fold the least went is that than truly not or taking The at the the drug factors plasma even exposure convinced and looked of trial. patient. at drug patients were levels in the time their this the at even point was they the back two We're we that

So system. they their had very little drug in

also events, correlation all hypotension, then those. found we any cases, all patients either of any reviewed of no with cardiovascular We drug of exposure hypertension,

trends was said, seen no truly we don't that such and our drug, time then. So it possibly to we but we all physicians since related at it's believe the in view, related, our that understand have

development And present. I’ll So Dr. then, the next ask moment, that. wants about he if that add to in milestones to I think Bejar, asked a we you

at We be for trial. on, data of the in plan So B-cell same all available data all will June. next provide dose and the be the AML again, at EHA the to on will trial again, data patients, levels, true all major the the release malignancy

XXX milligram level. to And that Dr. dose want will include add anything to that? did Bejar, so you the

Rafael Bejar

I look the at that hard if trial, all our would see there duration exposure the you other and other treatment. and seen hypertension. made altogether association point pressure And B-cell patients pre-existing us not in any with were the who instances to short malignancy that. the our the just And about looking AML study hypertension reiterate in both have come made like patients even we the in into change of any blood with a history of

comfortable as that So glad understand your we’re a is signal. it better. the to a recurrent one-off I'm very that this not described this safety took that And that that true analyze to is time you carefully question we in

William Rice

a he that's to sure back greater to the Everybody much gave the – But but we on any also ask I going Marango, the development make we time. time comments to wanted comfort. point. next the the trial We wanted that forward. good took just plans if I'll really know on take everyone and it, did get add Dr. patients immediately, clinicians understood regarding

Jotin Marango

thoughts Yes. I'll some echo Bill that you of Thank And question. the described Raf and Bill. mentioned for thank you, previously. the

the and enrollment all right test studies are really seen these now, they dose to Our you've broadly criteria. escalation, designed

are all We comers. taking

safety value that through efficacy that are try dose upon keep for a the to different we out types escalation, test So there of understand group and as testing it's because diverse that's of the are really types patients, try we the going to of to we going drug go forward. to the way only us different genotypes

us next that's how on following not a strategy us of that the data show So you. in now, cohorts right, group, to once II, going and the hints have really expansion be here. also we diverse Phase the of give but the something best that the to it's position value this mentioned will only the Thank past. from we're breadth we've is right And few

William Rice

to thing want one I to add just that.

you physicians deep not? everyone, patients, time. remind and are it relapsed/refractory a Is these related patients just it SAEs And that says, we step so on anytime for So what's often going and to make must to drug protocol. difficult as to our tease we these well, and all to to is DLT, back you it prior AEs that happens, It's drug-related, fidelity out. a expand. so must this then okay, for and have? refer to certain understand really that the and have protocol also If have it very maintain the the they that Is happened

We and level more dose of advantage abide by more get protocol and will we will patients that to that data. on then gain the take

I'll and you So that, leave it at question. Operator? I thank for the

Operator

Thank you.

question Newman with from Canaccord. Next comes John

John Newman

Hi, here. taking more of to my for Exciting guys. evidence the activity. on Thanks see congrats question and progress

Just had couple a of questions.

CR, exactly or the large And one us AML they small is of also a was and all The the have the can AML reductions the can do perhaps number? you you've comment forward can if also if And you samples whether to in number treated first is marrow curious cycles patient that we see across of Thanks. generally the it AML, you patients had before with for data all going the not have CG-XXX question last most sure you then saw of if them? comment or at expect seen on for tell number you just when patients EHA? blast the

William Rice

Well, something. little All you right. I'll John. a give

patient be quantitative and study the that at data So all it greater safely, was one on will than on now presented EHA. but continues patient the cycle

we’re and others blast go quantitative dose blast at reductions, the patients not up data both data we've was but enrolled already to bit for to but around level with provide XXX next diversity seen move I met, level. each reductions, two another at And and thing dose terms dose such do In a the to we'll of a all for I'm is noted it the EHA the several EHA, into we'll We presented all far, patients, of thus the patients, all level unanimous we the patients and dose again, want That's level. the on patient. on that of data milligram going on have here this unanimously. patients CSRC did emphasize to

of In comes patients bone to further the multiple clinical down series let Bejar from marrow. always the address a that that We samples to marrow I'll treatment. sites. throughout marrow Perhaps – Dr. of bit terms to a biopsies try get

Rafael Bejar

Yes.

bone the of to answer the study. we and screening So question longitudinally your them during both are collecting course about at samples, then marrow the

John Newman

you. Thank Great.

William Rice

at EHA. data that we Thank Thanks, questions. the all we present have, And the Appreciate you. John.

John Newman

Sure.

Operator

Thanks.

Biegler comes Oppenheimer. question Our with from next Matt

Matthew Biegler

guys. WHO can Greg, super with ITD response you what Thanks. exactly to maybe patient, for also just you incomplete I'm to tell I complete Would with can Hey, a responses? complete the us us but see be criteria? that a was clarify a per squeeze or in an considered marrow recovery this on sad if way the go, you Can congrats to bang. one try patient? question if more a And wild-type leave

William Rice

All right.

in So response. So true we Are are would you a included reductions knew in that getting you getting this marrow was blood? the complete people truly well, term That because was marrow getting reductions CR. there peripheral we in just included it. ask, really, marrow? We

patient, that. disclosed the the terms have we In of of status not

that. data also that to all provide add wanted Dr. EHA. to Bejar at possibly Perhaps will We

Rafael Bejar

Yes.

exactly Just you the point made that same Bill.

be response be that patient had the experts CR are as I can ask European they confusing, when qualified and real the you This CR shouldn't marrow-only. a about think criteria. marrow who

Matthew Biegler

Got it.

William Rice

helps you. the to Thank thanks And Thank it you. clarify. us Matt And for questions.

Operator

comes with Matthew Alliance question Our Cross Global next from Partners.

Matthew Cross

his wishes a taking for of adventures. be guys. questions the on to will next And yes, missed. Hi, from for Thanks me, He off, same first best me. couple Greg

had lux guess, the I for a question of continues, Phase a and kind then quick as follow-up. I two-part I So

kind trial starting or response First will at you activity AML, to of evidence off direction lux? inevitably least see in of see single-agent beginning like curious, combinations CLL to we're before AML now of as was need some as focus either the that I'm in go. Certainly feel degree probably single-agent the activity, of you what a

talks considerable and XXX before expect BID higher you'll The continue follow-up. and second trials? DLT question again until cohorts pop B-cell you that I'll or do for was AML part back And to beyond the of the dose then that both for combining, milligram enroll escalate

William Rice

right. we we show as The Matt. single-agent that seen us response single-agent important one. AML. in. can for All couple A Thanks there. in many AML, so for in calling questions responses have Hey, to of It's

We clinical want to trial to are of understand there subpopulations guide drug, expansions – are the help what going this our that AML also and that most subsequent then studies can and thereafter. sensitive forward,

not combos do combination everybody single-agent wants it course, big combinations, terms then see important was The drug that, first because your pharma we activity then, to well, talking see active perform will But the is of to wants about that, we us In start of to before will for demonstrate active. drug that. absolutely we to studies. FDA thinks, prove is oh,

for We that. studies. to So give already have we drugs about will the and combination I'm the going plans we'll little drugs – going not the about we'll timeline pursue you exact to We're not a timing But with. of combination bit talk the later. combine going talk that. to we're

the we we level. is in milligrams, of hope enrolling have to that XXX of patients the to safe, are a said Currently, up XXX where been, exposure trial patients XXX the possibly that's six is will what XXX have a dose it B-cell malignancy we XXX seen that the between levels it's between XXX the BID. the and in move milligram milligram valuable. terms we in show it that that has but full again, because increase In milligrams true, to cycle significant complete – milligram patients milligram we beyond If

when would toxicity, starting if both milligrams. increase see at starting pharmacokinetics. see again, But you if would we XXX like it's we add anything dose once and it to dose then the cap in well a the to plateau to look he the you're possibly expand XXX ask probably we levels assuming the will XXX the any introduced I'll then the the level, If at significant XXX. and milligram exposure Now Dr. milligrams. you're combos do, off XXX or limiting the we Bejar would regarding beyond that or we if tolerated,

Rafael Bejar

you think it I summarize Again, nicely.

seem much the try be see the any at to dose key push sense it wouldn't that see don't we that’s patients to exposure to toxicity exposures if If what in climbing need and beyond into point the to that, level we're milligrams. we So XXX issues. anymore, the especially running for make

drug important think that the of with combinations as is and go, headed toxicity. to other make but understand the is known far that in as a have I As would before the safety the it'll it that, direction single-agent the that do AML start combining to we be I field. And very think agents sense

William Rice

sounds like one Raf. Thank you had Matt, you, additional it question.

Matthew Cross

and both Raf those on Bill fronts. Thanks, Yes.

bear get around I bit on efforts maybe Just follow-up, pressing or more certainly of exciting we enroll of, an a cell a higher quick AML, now going we're know had Is stratifying particular rate? have news can to whether which been, impact of patients, Phase CLL you're begun have focus kind trials little whether levels. of a is get I the on some type? was CLL qualitative enrollment material and with the going the you're but to If seeing any study, bit a little kind to I some the focus for on update. dose update the guess these I that to big some of whether B-cell curious again, forward that lux kind fruit that at

William Rice

Okay.

very a good actually it’s So question.

we whereas escalate that achieving and at expect, it milligram dose well be we're that want to continue tolerated the we're XXX level, through to we PK to appears and So the levels level. dose

actually that we to reasonable we complete on, believe can So cycle. the XX-day want have get patients be to patients they

exclusively to on So we patients. focus going CLL not are

a they're patients, we failing. They're We now, little are to CLL but other will becoming continue enroll staying know bit bit all on drugs rare. they more that longer a but

some So I as putting about those you of other those not recently, will that that patients patients some drug that fail, mentioned name. and of excited we drugs our our on the investigators of just from have heard this they're experimental failed one

do we to is what need So continue to dose escalate.

but seen lymphoma also We we've will include patients. a in activity now follicular CLL,

so So within lymphoma many of there medications. diseases that types still new lymphoma and are need patients

activity population to we then in there, for that’s hopefully, then they And other in those and lymphomas. or show we continue once patients population drugs likely to that can look then So place in on CLL failing try the study, activity – plan fail have the and pursue patient broad BTK, this all lot other drug it of serve few drugs, a form hit they and of that need a lot takes new We we other population. drug wild-type a of again, mutant a but quite too. that pathways to pathways. can you inhibit can But believe BTK to and

we lymphoma escalate with that but to parallel will come it and be CLL, So that's for on and why population slow need in dose the also focus then will patients. continue along, CLL to they the

if and like change stops, don't you it's you the cry, you driving, sit lanes and one So traffic and lane down and move start there whine on.

in we lymphoma CLL so Bejar, best And get to that? too. continue on will the we we'll lane as move lanes other and Dr. there can, to any the with the try into and addition the patients

Rafael Bejar

this the earlier of what that with breadth our drug. goals of said study the to one really echo understand Jotin activity of I’d and is

to to moment. You ourselves any don't this limit at one want indication

where to move escalation we with opportunity the comers all to quickly take to we and expand. will address more can point can as we get dose that So

William Rice

Much more succinctly Thank and you. eloquently said.

Matthew Cross

you you and know Great. kind you me navigating on trial, these to kind are traffic for going going helping squeezing thanks forward let one. another both it. of me thank letting be Appreciate how for guys And to of

William Rice

All right. Thanks.

Operator

Thank you.

from question next JonesTrading. comes with Soumit Roy Our

Soumit Roy

on the to Congratulations mechanistic where wishes validating It's to Greg fruition with I worries least or you also to some to bring concern. third-line you the and plastic the feel of can rather can everyone. Are good patient, a another enroll you in add time my you than lux. wait what's not this a at building, you turning coming hypothesis endeavors. Do or And recovery? translating to targeting can clinical into this to would your – until what's earlier range will kind be on you Hi, that's – deep able most, best venetoclax with range his the of have this it a line data, see because you you your with into is think little future that [indiscernible] what is hematological is very big marrow? see a question comfortable One Is have marrow waiting strategy Or patients broad concern combine lines? such late you for agent? you – investigators activity. is

William Rice

All right.

question. the for thanks Soumit,

a talk I'll Bejar Dr. second over this ways So about I'll of to question the to there. in answer it couple then turn

see never a what to duration, AML length hope CR. get you activity. So bring multiple we and patients, that significant about what future with Again, these drug hope the want AML, is to milestone. real talked patients. a to you We assistance can But to this hit pathways about the provide of to the is you're That in do them in AML. certain going

avenues. single-agent can get these are we as as demonstrate then additional the try patients much so possible to there to to if And activity, CRs, benefit get clearly

to get able be not to You them a transplant.

forward. combination You might the this going for – you up and trials then sets also

you In benefit. exact patient. of to would malignancy expect So the be timeline AML into a patients, longer would don't an see get B-cell I the requiring duration that to in want you

and that your Bejar can turn he can to back I to questions. perhaps over Dr. So add

Rafael Bejar

Yes.

hope which But – the just to accurate different study. it So think mentioned, in you be nothing responses. then that's see really for will will I AML good that to it than we B-cell add, patients, certainly

advantage I parallel. think studies doing of have we in these the

So we in different contexts. the also learn of activity drug, we safety learn about not can only about but the can it

or on function, about have there. sense normal so that. including able to I'd by say haven't concerning but signals So that we otherwise specifically being may any a relatively who a And marrow and lymphoma test patients myelosuppression of get seen asked you have concerns, we

myelosuppressive the potential is to have would they and to then CG-XXX. in not the of that lines earlier of into induction same we interests AML course, if approved able to demonstrate come chemotherapy a for being likely have, those think different that about with unfit has But that overly to patient The that to given get don't question I populations move great not much So being safe frontline. inhibitor do regimen options a And that. benefit. we That exhaust therapy. point. Obviously, need diversity an very for the like everyone to all your receiving older the available of them. therapies first, And so without the they're example, FLTX it, patients are contains being

So whether not, they approved is or in do on nothing study there for setting. really that that them

a AML bring to to opportunity an luxeptinib think direction moving be drug is that might closer the I ease that But like that combination. So frontline. in

think other I to it'll to so that your be do So likely in with correct agents. have combination assumption is there

William Rice

would we that dose And toward… before went identify we Yes.

Soumit Roy

Thank you again. congratulations and so much, Okay.

William Rice

Thank you.

Operator

McCarthy one Thank question Maxim we with question Group. for more time have from Jason – you. And

Unidentified Analyst

for Hey, everyone. It's Dave Thanks on the Jason. my line taking for question.

action lends So as the mechanism the range of presentation, you mentioned to CG-XXX wide itself of indications. of on a

in that the I any mind, currently near you're if malignancies was at with other in looking wondering pursue So to just hematologic future?

William Rice

yes we are. So

then understand both in the to preclinical those base clinically. then first is hard begin which kinases hit that is explore do impacted So those science. by by are what it and on diseases, what We we try are and to this we pathways molecule. to identify One, targets then try and

We're yes, to well beginning single is helps tolerated. are think how continue. it's will expand. do and now that And see we the doing agent that see great that we us activity this being molecule really in we So clinic to still

single-agent have I to you drug part can talked stage. now start them. seeing earlier we all plans, – to you begin is confidence it's So the so now you're activity, of And next how – move we that's these what is about – you seeing that us implement that always giving now have to

long-winded does to Bejar Dr. But to of that? a add anything bit little want a that's So path.

Rafael Bejar

genotypes think different have in different sensitivity I is to may other that the malignancy myeloid the consideration drug. a only universe

that dose consider to first. the perhaps appropriate and need be them. explore greatest It's doing I other a might with area as the the exploring So more thing get we're sensitivity, that think we time and we're higher levels, right greatest to to indications by able AML

Unidentified Analyst

for color. Great. Guys, the thanks additional

William Rice

And like up, Dave. additional we before would I one thing. to hang Thanks, say

I'm heard know company been working out everybody they and this they Greg. I most have but from long I me people it's were a of that very I think upset, of not how be shocked time. upset, happy quickly him. I'm for if not. a proud they there, close was for am so And as through to I I couple Greg and wanted

hate. her, We miss daughter I so her. I But I think proud will company I him And was to into her college, next I she and everyday. that wouldn't deliver talk to going so see can interact, kids, hear get he's continue phase. went to this happy to that. and I I of IPOs. everyday. going knew And her for my just I I was to got do go oldest I metaphor is have knew deeply, I'm I to phase. to is what her into to guess going what everybody in would see she a I a wanted to off He's that to next to Greg her when talk got going his

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Operator

the in questions further queue, sir. no have we And

William Rice

all to most all, our help they're us that clinic. two, everyone now on tolerated compounds call our Well, hematology We're a the meaningful are thank XXXX activity there All no to advancing questions, we this advance a hope these mean clinical I'll just right. I the afternoon. since trials. and was these to clinical and quite take I'll the on we're well work. joining greatly further patients. patients but year, it's this for clinical see beginning focused this, trials, They of in investigators our mean, session important pleased them employees, today, of I come the listening risk on and continue to I appreciate,

keeping With a We also support, bye-bye. staying progress. Thank apprised analysts with everyone. thank look evening. wonderful our to us. for We our you Have that, forward your of shareholders you and

Operator

concludes This gentlemen. and ladies you, thank today's conference. And

a day. have You wonderful disconnect may and all