Aptose Biosciences (APTO)

Susan Pietropaolo SMP Communications
William Rice Chairman, President & CEO
Gregory Chow EVP & CFO
Rafael Bejar SVP & CMO
Jotin Marango SVP & CBO
Tyler Van Buren Piper Sandler
Gregory Renza RBC Capital Markets
John Newman Canaccord
Matt Biegler Oppenheimer
Naureen Quibria Maxim Group
Call transcript
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Good afternoon. My name is Victor, and I will be your conference operator today. I would like to welcome everyone to the Aptos Biosciences Conference Call for the Second Quarter ended June 30, 2020. At this time, all participants are in 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 Ms. now like would to I introduce Susan Pietropaolo. ahead. go Please

Susan Pietropaolo

Thank you, operational afternoon, I'm Biosciences. call second Victor. Good ended Susan to Biosciences the quarter Representative discuss conference Pietropaolo, Aptose a financial for XX, and June results Communications the and for XXXX. welcome Aptose to

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

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

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

William Rice

and your safely everyone that tropical you, XXXX. loved XX, all the East you call And do so all Aptose. the Separately, now, do quarter hope weathering I please to you from COVID. to are particular on I'd like that for our And Thank ended I the hope of Susan. storm, back safe to care. welcome second of June ones are Coast in take

Aptose two you're As developing clinical distinctive is assets. aware,

have a and BTK oncogene MYC suppresses kinase become high-profile, the CG-XXX, expression. that the which APTO-XXX, we targets and its non-clinical First, second has FLTX stage the first-in-class inhibitor, only directly agent and

that executing for levels Before patients the this a obtain with we dose with executing be to patients. you in demonstrate I CLL of or build wanted to strong patients, to in identify to understand we with an XXXX firmly CLL we of we foundation AML the to development myeloid and in clinical first and second lymphocytosis bring appropriate XXX. XXX accelerate may other that efficacy assets, believe of XXX plan enter half doses higher development we date that patients of original AML deliver lymphocytic on a observe XXX activity patients and now as on IND success both forward, new CLL inhibition pace B-cell track leukemias, and the plan. sheet of AML, We built the active in clinical plan bullish our and Plus indeed, parallel, note clinical BTK year-end. dose AML have let And can we going for should for balance by acute treatment support clinical both sought our expanding efficacy on develop by be successfully to to of starting chronic deliver and or up importance clinical year-end. In CG-XXX, the we are reach me of patients, leukemia and remember to primary to and we malignancies, for to on

raising sheet questions. likelihood in global patients with ago, boost uncertainties. provide the to So to the APTO-XXX we and after financials, our balance weeks shares the public I'll drug then A and runway couple of Overall, announced which a for trials, of corporate trials, a today, gives clinical of will and recent to a of at of with of than we initiate recent and healthcare assurance fundamental treatments dose million in effective multiple clinical More of clinical your offering years to multiple common more XX.X our capital, news. activities. increases will to the investors. I success participation recent CFO, open likelihood the first, a a from speak have with Chow Greg but us the manufacturer this escalating million market call will expanding to Mr. cohorts, substance the than the environment I for cash offering, our review our Company. right ability But our price update, express address Chow, appropriately. drug we likelihood CG-XXX most raised includes success of wanted Mr. and to for $XX development This the the of that $X.XX we're strengthened of delivering per share, will expansion product particulars the resources perform strong and growing for support this the just of two forward clinical to investors press molecules, financing pleased and our have

XXX-milligram XXX Association, turn clinical was with malignancies. European or and BID Since XXX events. drug-related or adverse over X EHA, milligrams, XXX milligrams dose relapsed to limiting a/b CLL toxicities that first our of demonstrating last these other led data receiving XXX XXX all B-cell that treatment or another escalate. milligrams. two lymphocytosis XXX trial XXX-milligram of our and serious Phase and XXX. of in thereby in well at And since multiple fourth to complete to call, presented oncogenic classic cycles data also CLL CLL XXX patients, dose activity includes and treated with Now, discuss and ongoing experienced the patients on milligrams, subsequent dose patient meeting, patients inhibition dose, the delivered we continue no higher, with CG-XXX level of lymphocytosis in patients inhibition rapid our Hematology we multiple tolerated in CG-XXX last call, This refractory BTK successfully we Based BTK. physiologic and the dose demonstrating and or our and pathways possible of phospho from completed data let's survival molecular classic

the reviewed the with escalate the fifth XXX-milligram to cohort safety to and review we I'm milligrams. Just of level that our yesterday, should we agreed dose that report happy committee, data committee XXX

of with deliver at so illustrates this In moved a likely intermediate for development keeping lower are screening we plan, on that XXX patients responses. and to milligrams. higher dose our patients focus now original more may actively are we minimum now, dose the that So that efficiently we with efforts the three levels levels number to

higher move patients longer that we formal and or the may to escalation higher this for dose periods dose time. in include across responses, may kinase-driven as activity phenotypic studies specific patients we patients we in different subpopulations additional deliver subgroups that to clinical on drug are inhibit of genotypic phase, with in remain will Depending into will expansion hopeful enroll levels properties. on our begin As of XXX begin CLL oncogenic pathways, doses

As and scheduled sites screening study, the of enrolling with to patients sites additional on for today, we have for board. XX come U.S. open clinical

malignancy on specific during note the in us so trial present patients, to in extensive to did more that at later plan we update and the data information much you. into a clinical do data the deeper visit a we and provide discussions with levels event, more the we as year, please That separate to For year. and clinical allows higher review clinicaltrials.gov. corporate ASH enrolling detailed sites plan enter Also more dose last

discuss most with advances B-cell second AML. and one CG-XXX remain patients relapsed with in or application marrow there to poor and for unmet therapies, persists to refractory cancer more a/b AML, of of and tremendous patients the the was quarter expanding a beyond the let's a initiation clinical malignancies. survival patients for Despite review relapse little Phase FDA's prognosis, of or AML, the with allowance XXX the the recent significant of Now, a the of XXX IND the the treatment of events is need and blood X rate study of of than our Certainly, of development refractory current in XX%. overall an AML new of will five-year majority bone targeted of therapies.

evidence treat genotype agnostic potential Brian strong including the activity, their cure is two-year across broad preclinical For fragile malignancies. FLTX against offers to relapse, particularly the and XXX's hope that of the patient initially Because difficult its well also activity survival demonstration example, gilteritinib, patients. or in therapeutic safely AML treatment of ability recently untreated both only than including we AML, Druker's of majority AML is refractory who patients respond approved possesses to lymphoid believe spectrum, giving AML, a inhibitory no myeloid as will ultimately, agnostic mice, FLTX the and in as different XXX of hematology inhibitor other and to XXX Dr. mutation strong we inhibitors, FLTX with as compared activity, a to relapsed BTK population. and inhibitor look to

continue the at for to will our might each allows and therapeutically in active and and exposure seeing in allowed study, BID. dose state these we responses the start for begin treating we traditional plasma The an levels desired three preclinical refractory this Our appropriate. range gives relapsed Aptose just purposely patients. Allowing to treat observed three is At three escalation. then protocol relapsed and steady dose from syndromes, in or us in the that sought CLL, I was combination we to in to refractory into we believe the if AML including with milligrams And that that. seek combination AML patients. as as additional success has Starting patients AML in IND have critically trials this initiate patients FDA the toward solely And led to and to that of of testing patients already enroll dose begin be important opportunity expanding trial footprint and in of mice focused dose appropriate. XXX. plan in initially at patients. patients, or minimum and in with opportunities Indeed, We was without kept in in the dose value more toxicities. AML early the we've to of observed design the XXX identify want cancers only in CG-XXX that approach levels dose a and anti-leukemic patient truly same this expand any observed CLL XXX strategy a cures to take its a AML venetoclax. model venetoclax this this dose there B-cell critically to mention in rationally to XXX-milligram and with just work XXX-milligram will the than done for of or here starting We ill XXX level, term. humans, MDS, activity too Separately, dose starting us plus ill be with with outset to major initially dysplastic us at population. patients XXX thoughtful with AML long us escalate is drug, the steadily the the deliberate MDS in our and on

running? allowed this and AML and where key visits. through approved we So, institutional IRBs initiation clinical site are Currently, board trial at advancing or stand we recently review scheduling up do sites clinical protocol our the getting AML in

the Center, of including taking to focusing first Cancer patient. clinical as process, Sloan faster larger we our the AML while continue such centers. third caliber, actions working startup and Kettering target sites Memorial to same also AML parts expedite the regional are to on sites, the quarter specialty high for get So, and cancer others are we we activation trial at tedious our We're enrolling the on board,

well FLTX as responses want mutation, having AML will with patients of AML, ITD as with with We early levels. as type the FLTX wild often FLTX, referred the those enroll cells or XXX-milligram patients with XXX-milligram positive demonstrating to to hope the dose clinical

aside. quick a Just

the a to continue Sloan presentation Cancer Dr. the Oregon the great section. the our XXX, and seen Stein execute our we presentation diligently originally Dr. now on February as Goldberg in have up Rafael the and the Aaron It's therapies. well this Memorial year to To set University, website of available as that wrap stage not crafted, featured treatment the on and of have Eytan age you on and If we from plan the provides we Bejar, into Dr. right in and need. Druker doses both resources Kettering an from KOL move Science Center, of Officer, Medical the on targeted Brian in optimism. AML soon with CLL it the we unreserved Chief AML. Health perspective of accelerating we with pace higher have and forward We're And at moving patients Dr.

we XXX see you at as during more Finally, on robust provide in update hope event we detailed ASH. and to December, a corporate a

our second inhibitor, currently APTO-XXX, Phase candidate a AML XB clinical onto and trial and first-in-class MYC in for Now, a MDS.

As we've driver major the a cancer MYC proliferation. before, mentioned oncogene is cell of

expression its up in of to elevated estimated be human fact, cancers. is to In XX%

been on pharmaceutical tumor has and among elusive But of in have impact as cancer As a an indications. initial malignancies focus AML a our is broader may MYC application development. inhibitor, MYC know, target a MDS. and XXX you inhibition host solid clinical hematologic development

been at all this inhibition levels to to we've of So, evidence evaluated trial observe in dose date. gratified MYC

to maximum our as that to transition, completed AML XXX reminder, level at per allow to designed single at which held patients us then over last in these call review is XXX-milligram the XX-day three of to MDS. no Since reached. high-risk our meter dosing tolerated is the protocol, still be MDS with suppression, us the On is in patients agent ascending dose or admitted AML continues The in five. on proceed and last cohort have to well to the being higher cohorts once Just study appropriate, have we we dosing Because and XXX squared Friday safe expansion clinical level levels, per protocol is dose dose to until mild dose, Phase a or we committee dose our to XX-day weekly refractory the week, relapsed four. cycle X schedule. tolerated as accelerate with a doses allowed administered

will have will to XXX patient So, we squared, about increase higher Greg with I see for the in Vice treated and which review still also this clinical doses, currently cohort. MYC quarter. responses. this dosing are dose of be a we now to inhibition Chief results over Officer, the four, learning a identified Executive dose XX% is level meter Mr. Chow, sustained At President Greg? who begin per a drug. our turn screening We're will that Financial patients over and hope and call who milligrams to

Gregory Chow

Bill, and you, good afternoon, Thank everyone.

underwritten the review granted XX.X XX, start then under of raising XX-day in share, have offering of at recent Let's with our offering approximately public on price purchase details million shares shares and million netting underwriters closed per million to up common to million. to date, previously offering, we terms. $XX.X we'll July of offering $XX.XXX announced the additional the quarter. common a an public the $X.XX been a the and same The $X.XXX On option

XXXX. into and As runway cash offering healthy gives the a us Bill sheet balance mentioned,

ended $XX to Let's equivalents, in to million with cash year. March now this million $XX and of and XX the the approximately come investments turn quarterly approximately cash results. quarter at We

attributable including operations, hand to Company operating offering, which XX net the During million G&A approximately utilized surrounding resources Based well proceeds all into the QX fund on and activities from purposes. planned sufficient development quarter, of we this research in plus to $X.X provides the on XXX, activities, current XXXX. with company of cash cash as at recent operations, the June XXX as and were

GMP Research were costs, clinical the and I quarter loss was have quarter $X.X and for for Moving one-time one-time clinical million, More $X.XX in and supporting or back costs continuing both is our revenues formulations including the be drug manufacturing XXX, quarter stock-based the net personal XXX $X.X Dr. and it the headcount And or With XXX income turn which trials excluding or items, statement, research related development Bill? $X the for and to expenses the of $X.XX will no $X.X detailed were that, per quarter. on we million in for of for improving activities for million, Rice. million, finally, and clinical to manufacturing information trial EDGAR onto $XX.X on SEDAR. share, expenses product share. compensation. found XXX and filings per for studies. attributable million development trials, to our can our G&A

William Rice

Bejar, Thank that Chief have you, Greg. Chief I'll Jotin everyone remind line, also on us Dr. and we Officer. Dr. Rafael the our with Officer; Business Marango, Medical

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


from Buren Our Instructions] Sandler. van Piper of from will first Tyler [Operator question come line

begin. may You

Tyler Van Buren

progress. Good of respect guys. questions the afternoon, and XXX. couple Hey, with all a to had congratulations on I

question is, So, are fifth that four and clarify that with Is to and that -- so, update? that time allow there enroll EHA? the patient? the that the you you know to the can responses who CLL enough patient lymphocytosis. that there you level, provide you referred is to And I generate the you data those guess patients completed higher-dose if same you potentially second that, at on mentioned ASH update prior I there patient an screening achieve also guys respect to that if had able you're dose cohorts, then new, to one is the enroll. level guys to patients to them dose Is And

William Rice

Tom. for on. Hey, Thanks coming

on progress. compliments the for thanks So, the

a also immediate we came so on also level inhibition, first an XXX-milligram BTK. For was additional That lymphocytosis, the that dose four. it have That's patient and separate that was underwent lymphocytosis mentioned the question, dose. CLL patient

lymphocytosis. But at active you an at the Those have patients. see These ones and had on with to we are levels. So, the rather particular that far patients inhibitor lymphocytosis terms XXX today, of you Ibrutinib milligram going speak patients that if BTK XXX dose classic thus in to some details and enter than CLL have. would expect are we're the trends we've trial that induced

So come inhibition that in into BTK all three classic have and lymphocytosis. seen patients drug-related of our study, CLL we've

dose regards Level planned level into with just Now have dose the we of we as to to milligrams XXX yesterday. move allowance X, that

immediately. screening So are for we patients

at have trying So two It you a get that at formal We've we we level patients. to, can you're dose usually in on if XXX CLL What the want we fortunate site we see to tell do patients months the particular, to to can. hope informed as the classic or want patients. that as patients is CLL as them quickly and we response we will the on we're We best takes least will responses. higher question time on in have I is, get see these to focus study? can

we months. can there. get are get Did very dosing, can get on them that hopeful two scan [Technical enrolled, we'll So then them We question? answer your that after them effectively Difficulty] them and we

Tyler Van Buren

your Yes, color, responses noted specifically very goal because especially helpful that's the in delivering CLL quote patients. of

questions. So you. appreciate taking the Thank you


from from next will of line come the Renza question RBC. Our Gregory

may begin. You

Gregory Renza

bit for some for How December. you my certainly disclosure curious updates Tyler's annual your those in December Thank could could progress you but help prospects and focus up and the plan. just and here. on could expectations but if counts, a will year-end maybe off of patient any appreciate I'm of of on for just that are are curious plans to on to those having frame question prior potentially on event that congrats any expectations, tee how taking evolve. kind the unresponsive just it. in team? building Certainly do there advocacy question BI data, perhaps potentially just keeping the you providing doing you Bill, really I you. then Thank to if also you disclosures little curious if perhaps,

William Rice

for Greg, couple coming thanks on. of Hey, A good questions.

the about expectations this for talk ASH. let's year, of particularly later So

now So entered so we're August. looking effectively right at year end we just

good the dose levels start patients XXX responses. as is can higher believe as get that will milligram quickly into we're our dose. seeing We we where news The many we able get at to we on can

drug and milligrams, started the we levels, XXX expect level. that that start as seeing we milligrams. that believe X physiologic get at seeing, have activities. But the as We're Level at should three particularly patients make into milligram move into mentioned differences mechanistic reason we higher these to in it Even as dose XXX dose active. is to believe reality, some seeing We us we I something XXX we

FDA backfilling. we an begin now get that's are how going Well, have amendment a we So more to us the it? on patients allowing from to

So expansion today officer I chief is a doing like about Backfilling dose the while escalation. earlier it. you're almost our think was it's mini medical talking

patients do when then that XXX. the we'll XXX time to later Yes, the milligram at moved the a we'll CLL XXX to to We by the say we patients XXX those to in at to going are trying we we XXX. of deliver shown parallel, So this to now. on and be reach backfill is patients responses. level. then we'll XXX then couple patients be then also able up hope XXX. up of In we'll And be They're patients hope is, year, it be at majority those that I move should safe, if in have also ASH

later having demonstrating the responses this at the year. increasing we're potentially or ASH likelihood increasing So ability of

years? them time the into the to to patients But and second separately, also see I ASH try disclosing The say and trial. Dr. So I'll of part add disclosures. December to What the ask between if us your then. by milligram in going on just in ASH. anything the a for now would to hopefully the wouldn't and then there that respond up that just possibly between of gotten expect we've and to and Bejar, anything I But higher moment. on second something is, these Is want be question part mid XXX now the need was you to AML dose, and we the to is, dose we'll get between levels, patients get give time we're reason

a If them get patient can getting responses continue to acute the this we the remind dose in enrolled said, seeing I'll possibly the in of gives to target blast we to quickly. patients and in get during anything anything, typically year, we second ask these add through of I by more view to least get response that XXX it As us like up to some to a then cycles on the level, XXX-milligram third With it in the start but what two first at year that, month, CLL, in two patients to takes up couple expect AML or we to and much he AML a if year. time third a maybe two to patients can in you expect a I'm cycles that see would do something the -- and before quarter milligram going you would the dose this an first to from leukemia typically opportunity you're Again, is anywhere level, able Bejar AML, terms of have months ASH whereas month. of Dr. what on then reduction and have period. you to patients. in take still happens

Rafael Bejar

we more will was perfectly it that I We're he levels. responses we that think much know on I the something AML. has XXX to at because now be has than responses. patients demonstrate different very about That's to to that at that. great to to longer might but answer, further and putting your sooner backfill needs that see give going us with kinetics, a these that definitely having push to think agree should do ability take statement response said that opportunity I just a

William Rice

patients malignancy B earlier, later there trial but we It earlier show show at the show are that we might we're it starting even though to be dose we started takes can responses may is those believe irony AML The activity. a that responses. though cell it starting even even longer

hope questions. I So, answers that your Greg,

Gregory Renza

Actually question around It answered sure my Thank was also the backfilling. has, follow which Bill. you. it up

additional dose clearance? patients the to we has prior is would could for confirm, have anticipate cleared, since so cohort that to that given safe recently mig that fifth that added be us Just there it to presumably, XXX

William Rice

we to it delete added a that sorry, lot are Not -- prior have had to of we background. because

FDA have the milligrams, have in to So patients excuse have reality, me, the completed three get show -- the that not you safely the CSRC show that and that XXX three you FDA, patients cohort.

to only XXX. XXX, try then to on move patients then as we can and start on can backfilling now both you XXX the Right quickly going the we're up as immediately You to get the XXX can.

Gregory Renza

the for Thanks taking question.


come next Our Newman will question Canaccord. line of from the John from

You may begin.

John Newman

Thank here progress the and guys. trials. and good on taking of questions for you agents my Hi, both clinical

you lymphocytosis, you So there. for saw other go be it's activity there platelets, seems Just wondering with at if a of changes is that of patient some you in lymphocytes some other great. can speaking the notice to along were noticed tell if you hemoglobin additional saw that marrow? there there just us decreased which question can dose any the increase if for confirm if example, you Bill. maybe may an like anything was to signs response, bone Bill, mentioned seemed milligram I'm broadly that an XXX that the that where in the if wondering you markers happen

William Rice

on asking that it to the due Hey, in is John, the question. thanks I in for coming thing is BTK lymphocytosis can clearly saw a able inhibition had drug-related When actually so we dose decrease, to lymphocytosis an right is event. dose instance it it where back the because drug, up. the reduce patients, we reduced, and of and actually take we the One confirm the then we're

able anything too there to But patient perhaps add want the many Dr. wanted information on to Dr. more Bejar not can address into the any to that? that. that markers, else that specifics little to other you of we until provide get was I As later in bit for I'm don't a Bejar, again, year. get

Rafael Bejar

Yes, just last answer has the say to finished simple I this referring recently one. would just is cycle you're that patient that

question. your but you'd haven't studies of additional the know any to actually don't we recommend So that we answer these done the

John Newman

No problem.

able to state that things in terms you're when regardless one had That give I enroll. a with know looking AML of the challenge, patients than Are is patients quick a is active a selection that to in chance you're the question fragile. of of to to criteria, are dealing agent, reasonable frail rather answer that drug I yourself of question, of always Just AML to that and your fighting almost disease? if just the it's frail terms very just very may. if population, sort follow dealing type of your up with the because be able you're do there you're

William Rice

Well, page on one. we are with the you on that same

thing So we the starting important first think most is should a we're active. did level trial dose that at we be the and

the that's drug the to best the that thing opportunity show responses. we're So doing to give first

the patients. one we FLTX for be drug highlighting of positive of terms well in ball that that AML developed fact feature of as is the this Secondly, most type believe as FLTX can

want patients about So able a of wild to two do we third with of so not. have be have the type the wild FLTX the again, treat to the FLTX. patients They those thirds patients mutated FLTX, type

of that's sensitive FLTX to the is to aren't patients positive mutation generally other because it shown a tend would inhibitor; the been some be with that molecules. of patients FLTX gilteritinib [ph] accepted ITD more with However, the

likely positive soon responses would as that So we I'll starting patients, to we likely. FLTX dose get pharmacologically the able some to the FLTX positive low us use will we And show possible. patients but is earlier, patients hope phrase till your may the the earlier. going are both in we in higher it a gives patients as FLTX then opportunity get active show questions. john, it hanging likely take the, type be trial But this likely us They absolutely great show of wild wild again, we most to that's a where showing the that on most won't We doses know get are want get responses. for Again, Again, as to most the type. to positive well thanks, activity on. and activity fruit we're these that to think on at as

John Newman

you, guys. Thank Sure.


of comes next the Our from from question Matt Biegler Oppenheimer. line

You may begin.

Matt Biegler

shed comment thanks hear in But meg Hey, for can whether you data too were premature you. tracking the a linear increase from Obviously, seeing Bill, XXX you that between and on the how maybe high we're to on Great XXX saw for my light set. XXX these are questions. guys, exposures still level, cohort? any the doses? EHA we Can taking

William Rice

XXX, have on the patients patient then XXX. and patient XXX, on three XXX then Hi, four one the we we had on Matt. the patients level, dose Originally, on and one

can line straight have So draw one you meaningless. really points, two a per but when between you dose level, it's only patient

can level XXX the So starts see the patient it XXX you dose comes appears plateau. XXX, what milligrams, level second the it next the to and go like looks to then as you another as about then looks you It dose the over have Because what level, three same outlier. two that it it to is is of more hours dose you milligrams, though patients, coming go fourth when that increase. and XX as the begins then was up like in

dose as the seeing XX are levels rapid So what is increase the initial uptake first more level, hours. that we is higher we over

effects dose-related more during able had milligrams at exposure forward. more at more now, are we're again, at even it's so effect. XX begin we're confidence see only the physiologic that so gratifying XXX. and that dose which linear meaningful like looks level to as definitely we us the we're some XXX it's XXX, lower necessarily we is a and than expect one not giving to exposure hours having getting we that they see there of the and at to patient but we're a yet because really then the plateau two levels, off starting So go first It But

So dose-related now get I as of giving we it's of call patients But but linear. oral on, and are would more also seeing effects an we not drug, different it more to it sizes. you're patients

the patient in to even dose differences will there level. same exposure always patient, be at from So the

Matt Biegler

understand. I Right.

lymphocytosis cohort classical were has of Okay, and we the terms and from that's EHA you one that third of Can be we completely [Technical with CLL, just was know the hear. clear the to confirm patient on patients that Difficulty] referring the type what was one the want Was four patient one transformed. cut-off? earlier? I good you just to Richter's what so in had

William Rice

demonstrated lymphocytosis that. the XXX XX-day milligrams. just That's that So patient one XXX That's of had milligrams, another patient CLL completed showed BTK classic the that the who we clearly dosing inhibition patient and was recently. lymphocytosis. patient a we have on on the the one they've and the And then to also that's gone

to and of higher lymphocytosis, in as we kind So now bit go well the XXX of as pathways. to us these the pathways able both clear other BTK get stay it the it's we these inhibit opportunity the little induce that we're And longer see to then a get inhibition we forward hopefully, the gives as doses, as and XXX strengthen as and on responses. patients

Bejar have XXX the add details to at about two without to that Dr. might So perhaps CLL something patients

Rafael Bejar


had then the had of complete patient were cohort, patients most cohort. this lymphocytosis CLL CLL in the pre-existing perfect one we cohort beginning So patient recent and the with at so the we two

Matt Biegler

it. thanks progress, taking Got the Congrats guys, on my for questions.


Instructions] from begin. Quibria Naureen come next may from question Our you will [Operator Maxim,

Naureen Quibria

likely data under me for see so? the guess first be thanks you one updates XXX for to be been my clinical at and question. have ASH would kind what Hi, the year's radar. running taking shared program. It's the would we if this any on of Will I

William Rice

over so get we go hope tolerability. we And next higher the X to recruiting on into in patients getting going we're for as it's safety, coming the seems quite well, Cohort be over data that We clearly radar we the be but dose X, was right, PK this to at now, would drug setback into; to ASH. we suppression don't cohorts XXX IV in plan mix somewhat now, plan four the on. [indiscernible]. PK have with as exposure so doses; favorable weekly coverage once greater that we coverage parent all different Again, drug both the biomarkers, the into ASH, response also XXX Cohort Cohort responses. that's we're had X sides administered start Nic different present the dosing; of a X, throughout days. to as screen can an it. of the then, number level, We mentioned, expression year it's on that the And XX-day to to data we'll at you're well present times getting from if able we're as But X looking questions we under days, were from able but gives most about we're squared, getting different people the COVID should ASH. now Again, the and data we the the that terms seeing [ph], various at and -- getting MYC from range an then then getting we're we as presenting that not the a because at actually there at the it, data once start increase cohort be as do PK to all yet, will PBMCs any well became of get but cycles, that's and per us patients hoped clinical getting We meter that accustomed seeing dealing we're more patients completed opportunity start they of get able a flying X maintain periods,

to levels can and to future. able the be the to extending doses, hope in time to drug that measure see it So we're adequate responses plasma be you in the able show of we're the increase helps beginning to where as

Naureen Quibria

the Great, about thanks. AML you're to in And CG-XXX start. in study of then terms that

I talk XXX FLTX February, active of in mentioned in that the mentioned FLTX was patients in there may if mutated you're capacity the mutations make to that may resistant may going context You patients be confer that inhibitor, proliferative KOL recall patients. that back gilteritinib. these but mutations have also both to RAF and AML And wild-type from your RAF

you that public going was just have ultimately when I be wondering, RAF with this mutations? they whether released? test information patients the So are also selected shared data is for that And study, are will the actually to

William Rice

patients want on get absolutely there. we to So

second you've you the of the gilteritinib; not a RAS, some on be they'll get give promise RAS mutations, there so RAS the there mutation so got have we can't just FLTX, different got the patients on these mutations gatekeeper are first that cohort, that resistance gilteritinib, or mutation are that -- want that I to number So, it's absolutely but failed to have in in of PXXs.

background, there; to in the those treat genotyped, also do to understand that with we about we patients that gilteritinib; who institutions, and to and the capability we one going are That's perform underlying are share sensitivity the have others have that make so the sure patients of we that patients the also them yes, genotype, that things the will especially mutations, at that we clones. the those in all treat those works. genetic genotype And don't. may those But patients to have the get particular of So reasons understand on, begin get we centers, and look that think on of the going of want and patients -- the forward whereas want we the failed potential as it able we're exciting the this to specific follow that's one and cancer analyses the has drug, context public. to the to

So, question. Thank good you.

Naureen Quibria

me. And just it. last Got one for

BTK CG-XXX So, the as on drug, say. but shall we same a player,

performed it's on or they COVID? getting but curious I how of and of And of actually do you was have any have are wondering, just any I AstraZeneca don't may not that, if anecdotal correlation, CG-XXX? any COVID you know BTKs evidence. your anecdotal stories direct but testing know exactly larger to you some have a their companies had the have I that I patients evidence patients. in And plans any was

William Rice

certain but -- responses. for is So well COVID measure utilizes complex, Yes, activities, RX you're acquired aware there; it with you're in can the of drug in study this lose groups; are this our and act future, something inflammatory talking the either potential asking and used are studies possible patients side, have molecule the COVID; if cleaved or we how focused we those to ROXX we'll processes we time. don't hands the AML and data, from the time, our can full potential and be on want have this as indication that NLRPX we But that could we of we us But at on separate remain we'll have the do a know future. emerge so there drug would collaborate there the and any [ph]. don't focused our we the because -- focus. if point is those about remain to caspase-X, not in those it the inflammasome is midst CLL, a at like with releases in this If a this we any to how of on

Naureen Quibria

it for Sure, of me. That's you. Thank course.

William Rice


me let on line. the to wanted So if Dr. to is anything add Marango that. ask know I he

Jotin Marango

Thank No. you. thank Bill it captured fully. No, quite you, Bill.


from Newman we Canaccord. And from a follow-up you. have Thank question John

You may begin.

John Newman

the Thanks follow-up. for taking

had just -- patients talk those previous to about to trying those whether other all us evidence you can exposure I'm So if shown if to to patients? happen the inhibitors? And you on know have that what mutational status also, had with Bill, curious, be lymphocytosis just might Thanks. CG-XXX; BTK wondering recall, of patients for

William Rice

right. All

two round for back came here. around you So

seen. they pre-treated So Dr. are can I'm bit what of types ask classic the going CLL as again, he different. with drugs; so I have in these background But of terms Bejar all the a are can may different you, in those patients. of all context of patients, to tell those patients terms to heavily they're if give

context. bit little of a So

Rafael Bejar


been targeted of of drug. have a exactly you're majority chemotherapy as prior very so refractory that mass as it's already agents for them well or But these think inhibitor well and I other received therapies, and prior [indiscernible]. having right. the The pre-treated, as just are either some many patients many heavily immunotherapy. patients have other received as Though duration BTK not

John Newman

you. Thank

William Rice


but different also I these depend cells failed so they relapsed for activity, so they they the do refractory, upon means lines the other are of these pathways. It depend all is, many think BTK kinase-driven patients -- part therapy. remarkable on

to pathways drug refractory that's a inhibit it's inhibiting relapsed receive deep important be sufficient deep believe because relapsed refractory we So is can multiple why for that don't in going patients. to that BTK these merely patients so these

there. some from out other of that seen we've drugs the think I

And these so hopeful they the that see going we're doses, multiple Hope higher like because and patients, we're we're drug to in as need that answers. to hoping them get responses seeing these pathways this. in we we're affected, desperately a

John Newman

Great. Thank you.

William Rice

Thank you, John.


showing currently further back over no closing Thank will remarks. Rice for And I'm you. turn questions. Dr. I now call to the

William Rice

everyone especially teams, have the our support to patients this and our for you look in I for our key I forward to higher patients for us progressing investigators, and XXX, for to detailed joining in keeping wonderful It's progress. updated two to delivering our our to dose to committed assets operations hopefully ASH, and Well, clinical year us thank our today. update. been on a and very clinic, give want you, development want and your evening. an we particular, And mission, at thank the clinical team, with later exciting want XXX shareholders. levels, helping In appreciate we now thank into time and be Bye-bye. our we able say, we a the us we'll remain this


concludes conference. Thank That you, ladies gentlemen. today's and

day. wonderful a You may all disconnect have and