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Aptose Biosciences (APTO)

Participants
Dr. William G. Rice Chairman, President and Chief Executive Officer
Dr. Rafael Bejar Senior Vice President and Chief Medical Officer
Dan Ferry Managing Director, LifeSci Advisors LLC
Gregory Renza RBC Capital Markets
Matthew Biegler Oppenheimer & Co. Inc.
Li Watsek Cantor Fitzgerald
Matthew Cross Allegiance Global Partners
Call transcript
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Operator

Welcome to the Aptose Biosciences o Incorporated Reports Result for the First Quarter 2022 Conference Call. My name is Darryl and I will be your Operator for today's call. At this time, all participants are in listening-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference is being recorded. the to turn Ferry. now will call Dan over I Dan, begin. you may

Dan Ferry

first to afternoon are and website. Biosciences the release XXst, relating Good The a you. filings financial release, Aptose the Earlier operational ended today, XXXX. and for to financial Thank SCC press discuss as Aptose's welcome Aptose well accessible issued related March on to conference results results. these quarter news call as

and CEO me Officer. G. President Joining today's Rice, Senior Bejar, Dr. call Medical Dr. William Dr. and Vice on are Chief Rafael Dr. Chairman, President,

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

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

Dr. William G. Rice

XXXX. to in a and everyone a update want KOL we welcome plan event around call our ended first the quarter Hematology our we'll today inhibitor I hold Association March is because update. Dan., only just month-and-a-half weeks, conference the you, Thank ago kinome EHA which for the want lux Because as ever and well-tolerated European XXX brief call XXst, last to and active to was HMXXXXX corporate few you just Aptose well-differentiated, in best or that we've to call two position drugs, provide been a in we with it. with luxeptinib I a or Today emphasize or

faithfully corporate and maturity. to continue we're a execute We entering on our new stage vision of

conference both cancers. deliver to about Medical product not over candidates. discuss and oral Officer. to Chief Chief few to remarks inflammatory will a a And application Officer, diseases. a our with want fact, new Dr. best-in-class Commercial believe lower activity Bejar, candidate, for NLRPX the before we I our kinase to achieve on and AML upcoming plasma with In inhibitor to Rafael the him, about treat the lux we of and lux and why clinical designed adverse lux. to lead with the in which disease autoimmune Dr. -clinically activity particular highlighted doses of on the greater remains updates turn of I will demonstrated the the XXX, superior make microphone make mutations. inflammasome and EHA Bejar is target AML, in new about is treatment B-cell But the a AML with XXX its effort to our strides we've well-differentiated treat patients Dr. an mechanistically just has agent exposures recently competitors formulation And continue pre potential and Plus, Again,

already FDA orphan AML. certainly a meaningful the AML had patients. have received welcome has news of that granted the the the of it FLTX to designation patients relapsed designation who refractory XXX benefit to FDA -mutated event of is recent mutations. from that with codifies demonstrated highlight or drug news treatment recognition with for XXX XXX as AML status begin the Let's timely designation is XXX. previously fast-track A our has And for FLTX fast-track clinical treatment to

status and As supports most of XXX efforts potential patient acknowledges advance AML facilitate need frequent which we development, helps a the as have communication also so and with that an designation you drug's resolved fast-track expedites potential towards unmet quickly. 's the fill populations more are registrational early us aware, fast-track for to and questions The and issues to allows are our FDA it study. potentially

Vienna. prior and is abstract a conference lux. accepted to plan clinical we KOL on been dose patients corporate away. XXX during for for few enrolled present which plans EHA, notified in presentation event our and plan But to submitted just recently hold we to all that poster all Now, trials in for upcoming discuss weeks EHA our were the XXX has data We a a we clinical both let's encompassing research available just from an EHA to than preclinical levels

will data We the embargoed. the FX not and KOL continue will of up [Indiscernible] until data be corporate PD collect to event efficacy time PK, and such

to patients. also GX you GX will collected the data For Data being our over few from weeks lux, to with plan KOL on at next update the plan new formulation we available in we corporate and present detailed continue the patients and AML data clinical the cancer receiving event.

during complete XX-milligram potentially that curative CRs ASH cohort, in five which we regard stem to the remissions allogeneic advanced the with cell presented XXX, Regarding the of conference of transplant. four December,

remissions as to trial. regulatory manner, toxicity. testing with doses focus is with multiple with our awarding chance I a during more complete a illustrates PR, recognized that a now by avoiding extended a the risk dose durable remission that that could levels: flip recently, Aptose and a including remission In another in CR, are Phase clear year. therapies. highly level. numerous already recruit demonstrated to Also, with CRs the that been More tolerability. by we who FLTX to at of And XXX from experienced a the patients methodically the for adding expanding patient RUNXX doses with CR experienced in other CRs fast-track by partial safely response dose, the a we AML multiple XX-milligram This or dose two now data Consequently, select refractory Phase identified with of approach optimize capability I that by XXX-milligram at exhibit a addition, designation FDA XXX-milligram By the the with adverse in than already failed December. XXX meaningfully MLL that this minimize mutation. safety -- patients has one want patient and diverse array in XX experienced to TPXX that transplant our we wild-type to already to or one reported higher for trial disciplined milligram we I and dose pair dose these patients was our XXX and and for had with maximize or ongoing we patient best have level AML reported life had exploring dose relapsed complete We in EHA, unfit and harbored one patient be This and milligrams have a mutations XXX XXX the at that mutations patients AML three -mutated different patients.

to with trial. further of in is to explore of adverse attempting and understanding solely we are trial our CRs in Phase full designed a patients a XXX. This mutations, mutation the diverse activity focus the doses we also X not we and want on range activity in have host seen of patients patients this However, to FLTX-mutated other FLTX breadth profiles. of with XXX wild-type of of Because

the avoid patients the deliver unmet fixed adverse approach CRs co-mutations, patients, select lower should XXX focus part patient have with we of our believe to to percentage dose genetically future in as goal value defined treat investors. studies us the and populations. be that physicians, expansion this and in appear greatest then appropriate AML While in with result near-term our may these populations allow need populations sensitivities to in select a medical initiate and those to is clear, populations to trials of To in the to patient this to to

first is populations trial and Phase this patient the information. already to we appropriate I is believe identify the ongoing delivering The step

selected Second, trials, we expansion for for go-forward the identify these expansion dose. must at an and well-tolerated dose efficacious

-- soon the trials to fact, are In packages we expansion safe at both FDA X request are already present Phase populations. in data the an has efficacy plan efficacious of and use from expansion least to identified with year, the trials thereafter. compelling, and registrational can that dose initiate and the doses pathway. the then optimize safety ongoing the patient In those second trials we along half specific our successfully two in are we accelerated to explore and request would that the allowance If sufficiently to selected expansion go-forward

course, desired for the but direction. this plan XXX work plan is much speak to KOL ahead Of of more event. corporate is about delivered this us us, XXX. in the that date this There We results point has path to during

its with announce As this KOL week, an the logistics to FYI, corporate later event plan abstract. formerly along and we EHA the

Now let my me turn subject. last to

company's the comes building of to right the maturation the products team. With pass

Europe. for he lux. transformed a clinical any he the leukemia. commercial all and held his he is let's kinase major the Aptose executive And member outcomes from added activities team U.S. Merck, year lead Most on compounds on with and Druker Commercial over provided to chronic screen products us comes patients Strategy he Prior, he the Vice Director launches pharmaceutical discovery more the Officer, priority commercial brand Senior Raf. our has Brian Commercial Need pioneered team. leadership including at Philippe Novartis was Oncology, to responsibilities for Dr. Ledru responsible acquisition Early pleased Bejar XXX and join and at hematologic on XXX. XX-plus with development brand-name experience served actually Most products. inhibitor tumors XXXX. up on was agents, Head XX fit a for work our leadership recently helped management the of in Philippe also in to say Therapeutics Aptose, where including Merck lit recently recently, marketing him over I development M&A to development myelogenous he drug Peloton what for FLTX focused as new he Oncology Chief commercial radar President Dr. At of spent licensing Products of There, U.S. his France. mid-stage Gleevec, drug that, oncology and a fully Prior on to several early that career across in with Aptose, of so, ArQule strategy our Aptose very about the global that and and a timely we've malignancies. oncology he the solid and Novartis Associate to a joining the pipeline, give Merck landmark Dr. also assets a several Ledru, industry exceptional by I'm and New on the imatinib, midostaurin. team. inhibitor us and Earlier for commercial in joining brief interest of With commentary have Dr. we're delighted a XXX and have approached including oncology

Dr. Rafael Bejar

position treatment [Indiscernible] Bill. B-cell malignancies, and of of for kinase We're two for AML having fortunate oral the AML, both HMXXXXX the Thanks, inhibitors well-differentiated cancers. in for hematologic

talk First, XXX. about let's

inhibiting a candidate demonstrated highly that already other is wild XXX product type FLTX both remissions multiple and tested. of or inhibitor, has lead Our effective all FLTX complete forms CRs.

FLTX highlight be In oncogenic disrupt as targets, It to is FLTX gilteritinib combined an more XXX to among venetoclax fact, and resistance. also kinase demonstrated and that best a tested growth CKIT, language, activation forms such inhibits avoiding gatekeeper when simpler with is as FLTX JAKX FLTX proliferation emergence and or compromise pathways. in class inhibitor treatment the MAP a ERK while kinase including the mood JAKX lead of agent of with as kinase may factor inhibitors cKIT, resistance the ITD, resistance including with TKD rescue pathways SYK, inhibiting as as azacitidine. FLTX, competitors may than or safety. to conferring superior mutation, all of can mutant single just a that it that JAK/STAT inhibition important well wild-type validated forms particular of XXX resistance-conferring forms interfere pathways and mutant In as in other XXX inhibits as of targets signaling may and with and to from well pathways others it

IDHX in patients AML a kinase An active and or relapsed activity domain XXX As kinase ITD and in milligrams XXX model have FLTX of profile XXX an already includes diverse well-tolerated multiple to the I'll wild-type XXX we at remind the durable, refractory broad well Phase a harboring in this TPXX, with combinations highly FLTX. even trial have efficacy suggests milligrams tolerability. patients mutations antileukemic drugs can pre the XX into and adverse the reported, we remissions and as far. of already has as inhibitory the are thus with and other of of array paired array NPMX, -clinical with create have We disease. translated treating tyrosine you; complete patients strong, RAS, be co-mutations, at forms paired that delivering effective with more striking in animal with in shown X as extensive drug genes drug

to expansion ensure window, reduce no on asked efficacy about in dose XXX-milligram of we the cohort table. activity therapeutic leave to we the breadth risk sub-populations XXX exploring Now of characterize on the We're of different to often full patients. regulatory AML the and are an

two-thirds, to at multiple treat population. it to antileukemic since illustrate have as and frontline [Indiscernible] refractory patients, and observations well FLTX been the to appears Our dose so has of AML, AML mutant FLTX a diagnosed patients, wild-type today date unfit as patients and about third other doses well-tolerated as potential as compromising activity at both newly levels the the population, fit the well active relapsed XXX

exploration the types ongoing according drugs. In I patients FDA all for that in successfully guidelines, the crossing designed our be and dose "dotting used " Is it exploring In expect AML newer addition, extensive Ts we the expansion are combination to in with ops. trial, can we other in Phase of dose

inhibitors, patients, mentioned, on seeking only have received Rice [Indiscernible]. we're in -mutant not focus previously they current other validated even in patients FLTX active As if as already FLTX-mutant such is FLTX to XXX trial. our Dr. We

so patients. now seek So can we mutation treat profile a better we define to appropriate to susceptible XXX,

We are with deliver thorough XXX seeing. patients challenging clinical RUNXX. can with and responding that respond of subgroups XXX breadth XXX and will likely that seeking adverse AML CR list of abnormalities in mutations, of patients we're help patients we're our our We what This to appear as the AML gene, or mutation us to in of includes in likely to to thereby believe of this patient responding to in MLL a deliberate, those the are undercover patients encouraged capable phase responses are by who a harboring genotypes as revealed development. to the to XXX. highly-adverse less genetic approach of well guiding define CRs growing forward respond AML respond, the path recent next

take could and have discussed a already doses, in we call, that and dose As identified two we milligrams XX our well-tolerated active XXX milligrams, serve last as expansion to trials. go-forward into

details AML XXX and accelerated to further and explore over next genetically our pathways. dose we towards to dose defined collect our next of time, registrational we at expansion all few continue populations studies eye expansion plan patient [Indiscernible] milligram so it month. event optimal to XXX select dose the the data and continuing we providing date the corporate the initiate select data an Well, fixed disclose not with available may to this we're weeks at We patients levels to are

luxeptinib. quick a onto review of now, Okay,

activity BTK and potent associated observed tumor the BTK patient Pre the potently avoids agent patients. the far aggressive had activity engagement greater original the orally to target in consistently a a models well lux XXX the toxicities. at has clear and these report dependent exposure and in disease. only to did is formulation has even dose achieved of demonstrates levels BID antitumor exposure not FLTX lux drug level. multiple milligram absorbed in are animal demonstrated dose in that antitumor the that reminder, the targets patient, a inhibits with But including reductions -clinically, AML and of cancers. administered FLTX enough CR in Just known both we one that exposures less with achieve And for relapsed and drug clinical lux known precision Clinically, often treat effectively

As the made to formulation lux dosing clinical may evaluation and that After report level, of we've in last we new significant three the in XXX be two collected milligrams GX we original levels, patients to dose GX enable pleased across a different dose ongoing then the dose patients. for our our and able which our on at for which to the recently samples competing escalating with and greater I'm of direct exposures formulation we dosed comparison. mentioned call, GX have now received call at patients a patients GX program. progress PK go XX-milligram dose, single are lux to safely

date discuss PK our we As event. the upcoming call, and data mentioned them on our are at GX last in to to encouraging plan KOL corporate further

data ongoing We sufficiently profile. take can those single allow PK escalation. which studies PK formulation, dose the continuous the continuous to model to and data and FDA GX define to continue us transition If profile those to fully will request us with expect dosing we compelling, are modeling dose dose the plan the with single will the we to data, from to PK allow GX that dosing

greater delivering thereby substance addition drug the amount drug In to higher the drug and we exposures in and expect may trials. of manufactured substance GX responses, amounts potentially that the to product of to the pill burden, may significantly administered formulation the result patients, support reduce

drawing out me let recent three release lux. of highlighting the attention review to publications lux the by press close Finally,

insights lux -induced ability of at novel models. inflammatory along inflammation-induced by as effects provided makes One [Indiscernible] NLRPX of as inflammatory inflammasome which the to for luxeptinib in well well inflammation treatment toxicity pathways, autoimmune which candidate inflammatory those to tolerated protective autoimmune its signaling with of and the against inflammation, are in related endotoxin potential with in resistance interferes cancer. a into papers disease, patients The and clinical diseases, and was pathways concentrations associated it mechanisms inhibit the of

look We month. remain and clinical are We to regulatory providing very progress further you pleased discipline programs. XXX our to reduce to the our next in we steadfast risk in with lux updates and forward

For more clinical trials and please information visit that all ongoing our are recruiting clinical on patients, of sites clinicaltrials.gov.

you, financials. to Dr. it the turn I'll now, back Rice, review to For Will.

Dr. William G. Rice

Thank you, to our ensure approach impact well the and deployed quarter, into we quarter cash to extends is reported Raf. take And high last a agents fourth We our to cash management disciplined studies. cash as the of XXXX. runway

So let's review in cash, our million investments. $XX.X XXXX XXst, approximately cash ended We March equivalents and cash position. with

During approximately the loss share. quarter, the into was per $X.XX translating net million approximately $XX.X

the As providing no the down of from the G&A quarter the for $X.X development and income from were statement, during same during the With turn Research for to million compensation we revenues the the quarter down reduction the for decreases of million million we the quarter million that, $X.X of stock-based XXXX. first XXXX. in first to of primarily approximately quarter expenses to relative XXXX $X had same $X.X expenses were due will quarter XXXX. session. from XXXX, quarter Q&A

introduce the So if first would you Operator, please, question.

Operator

comes our And from Instructions]. Greg. Go ahead, question Greg first Renza. [Operator

Gregory Renza

the I'm about certainly to success. there, Good Bill of on looking for the could for strategy, really just if afternoon, come think should XXX molecule just you Yes, touch the question. and profiles. those and taking and diverse your Bill, involved mention how mutation just the curious my at it progress we steadying up team, hey. inputs on congrats to thanks

And fully patients getting commercial just I maybe the path the to and the timing, how at alluding results. respect you Thank then the in you it if add presence if to and determining that in pertains are lastly, even that just Looking much. weaving you so forward. end with could inputs to

Dr. William G. Rice

question. extensive an that's Greg, Thanks,

I'll ask to in. Bejar Dr. I'll So begin and jump also then

well. inhibitor? FLTX been inhibit it say, we well, does been forms clear asked, this very And inhibits have So FLTX of it's FLTX is it tested all of we've a course and that what that is,

gilteritinib. mutations feel And can including those of alloSCT we so, other with as who have into been we have and patients mutations by such move FLTX failed and those variety a confident already that FLTX including inhibitors

as to mutant to inhibit because it So competitive. SYK inhibitor rescue that molecule cKIT be of inhibit those FLTX forms can this at pathways then well of well or But positions pathways, that that to compensate allows goes its for. the a those and beyond JakX, ability very key JAKX,

pathways the other say Let's those the rescue you able suppress pathways. is these drug sales to inhibit also then FLTX but can while

kill a kind of But we we've patients are does have are by cover in responded said of mutations covered our TPXX, FLTX to of So mutations the drug TPXX all drug? seen had understand we're we able means patients to the who be able adverse pathways those wild-type patient and we want just it we've seen Now, the mean group variety to a such that that to to a full responded. actually that cells, mutation we've that not CRs there. the want patient be already That in going enough have this to of drug. inhibits a their breath the activity, of directly

now our can. different we current now Which Phase mutations many to as getting right breadth best possibly is diverse on can. trying mutations of we against we're means as task focus activity all really our these as those in X types fully understand of of to the trial, So

MLL as mentioned, want new that well Dr. the so we on that the a to mutations adverse As with in Well, a can. patient, that group a co-mutations get just as many those Bejar CR are recently, RUNXX. as had we a of we had as patient brought of

into ones of our that these respond, will now which trials in to which know guide want to then not likely types important patients, we that's Now, going percentage it's because will respond, for see us of a have but we'll expansion responses lower future. the ones

actually the to that in to be it, write So move we'll able expansion it we're hope forward. dose the we going collecting to FDA. to expansion we're be the call want up, And select data those three We to we that get the, patients. can have used doses on Identify maybe that these cohorts.

to point, this it let me and and the this patients. at about Bejar So speak Dr. can he over more turn

Dr. Rafael Bejar

Sure.

Just from learn the not Well, mutations. that lot of would a know only and the clinical you free can their patients lot improved drug you add you'll a about -- affecting the which that study, molecular learn in do that. is I how enough basis disease

So And particular can mutations are when patients controlled resistance study, generally getting mutations. then if what baseline. that responds a have what patient on understand at we respond, with a resistance be started patient if you're mutations or we we and a mutations then understand those relapses, primary never might might understand

drug patients learn cell about is the population kinds be the to to of can but are as as identify we thereof. straight have or And beyond what narrow FLTX lack go as from and response obviously before, sense. patients shortest have that stem or whether driving by actually or patient they after talked we've for more we relapse that wanna are these respond the things And into are then these disease, going not that this use cured in therapies not factors to transplant. So a available we that targeted populations focused adverse unfortunately might

to out there who mark patient to we there us Phase will be that focus may are we are but great on allow benefits alone and X So they population and others that just in might trial drive on focusing these

Dr. William G. Rice

that you, developed patients that, plan. Just And pathways so with NPMX hope how Thank drugs out mutations, other we you question. this these pathways. that's I can targets being TPXX, your want for there our with to see and cover we to Greg. module, other to see of various many answered add

Gregory Renza

does. a you guys very the Thank sure much, updates in looking to forward weeks. It and few

Dr. William G. Rice

Thanks for here. being

Operator

from And Oppenheimer. our Matt. Go ahead, next from Biegler question Matt comes

Matthew Biegler

the Maybe two Oh, for can in. question. I squeeze hey guys. Thanks

want strong the with or are it just ago. just I you're a should guess, what with then patients use pursue actively as outside relative expect for to something obviously, shared XXX And you a I you B-cell couple First, partner? a number disorders one. us saw is how we far data at guys need sneak of Is for so ASH. that this that in inflammatory tolerability that a I given luxeptinib's sense window. good maybe weeks cancer. considering we one therapeutic to new at something would its you appreciate do That's only -- EHA Thanks. about preclinical many

Dr. William G. Rice

great your Thanks, again. hear to Matt. It's voice

Regarding how December? many a have handle good we're going how patients a I you Bejar since exactly to on sense Dr. second. give have Maybe in a many. can don't

into So second It's for of that developed your question. let being these inhibitors outside it flip inhibitors, just cancer. SYK inflammation. me lux, are clear of some BTK

lux should the actually apart within fact the level, quite all remarkable from three began And levels and pathways at way four all pointed the that way to a we going pick series down a these long-term expand the initiated And now and look the be and And animal activity, we're pathways. activity we've of the which and molecular in the so, activity. the the delivering both the to to original because seeing the look have and we it pathways were models. surface, inflammation then in cells various inhibits, seen through that to we forward trying we to dosing you're in we said, as models And animal this, for with like move also to formulation, and out It's originally were diseases. our these and animal of able we're inside signaling the at really models it say started of autoimmune inflammation kinases that And at you types diseases we there. in these patients. the kinases new orally autoimmune in important, are hid disease on formulation cell using

lux have well these aggressive are to want know a kill cells. as though that's these have that very tolerated could doses tolerated. very appears is -- lower autoimmune doses it required well diseases. effect you an that well, So to malignant and drug Lower and We on we inflammation

we are So, pursuing yes, this.

until animal and as up us. we'll that because we make we'll quiet sure We -- are follow where we're we into extending again, now it data, the pretty But additional will -- now always, data. have then we animal it takes models, we wanted to kept see

So I'll ASH the flip add wants to else anything also and inflammation. the and patients he talk to it to lux about and if back to he if Bejar, Dr. wants then EHA between

Dr. Rafael Bejar

Sure. Thanks, Will.

data the I'll remind that actual the So that meeting you a itself. bit was quite ASH, before for ASH cut

picture spend wasn't think with I how patients even total run of ASH, So many it at a time. even that

have assumed additional we and the exploring meeting, already we're that the expansion So We've trial XXX have XXX-milligram had after patients. milligrams. reported recruit now and that we a dose completed

So you'll we out the have XXX all and are the of patients on that, XXX. date see to the the that that all filling data

Dr. William G. Rice

But have a of good number of so about sorry I the there, out on don't exact Matt, patients number that.

Dr. Rafael Bejar

now well change may it And between then and as well.

Dr. William G. Rice

Anything It you the daily. to say about It yes. changes inflammation? want else will,

Dr. Rafael Bejar

areas I disorders. And it where in think actually talking an lux exciting several potential a But context. quantum driver obviously in mentioned it's conditions medical to about explore I that. B-cell of appears inflammation's -- address and opportunity the inflammation in of to other We'd issues, even inflammation's And where plays inflammatory cancer role. the disorders be it. isn't briefly factor has that is lux you're a resistance inflammation because interested all we've different one places think therapies, like in a in in applications

Matthew Biegler

stuff. exciting That's guys. Thanks

Dr. William G. Rice

you, Thank Matt.

Operator

Watsek Li question ahead, Cantor next Go comes from from Fitzgerald. Li. our And

Li Watsek

guys. question. taking Thanks for Hey, my

broad this efficacy what XXX little can of you on also, more you many do comment a it And bit you dose, seems now? view, pretty XXX has saw mg on how the dose patients and from activities. right at like have point First, the

do population? you that expansion threshold to have patient particular cohort for efficacy perhaps, Thank what a open, So you you. in

Dr. William G. Rice

question. Interesting

we've seen at and and and So we've the efficacy at status to both that, we moved clearly, at up the reported on XX both expansion XXX. then based milligrams. well-tolerated milligrams And XXX

you of and daily. to their get see Bejar have washed to changes those. drugs, of XXX out patients yet It identified, We takes prior on, hopefully released at the get merge, the them on and responses not that then get time them a months as study, confirm you Dr. several number over patient

And months. so that takes process

the them. is and the mutations, patients, so, EHA, have all disease, everything patients, that's now all about will types we with We'll available. and where And have do of known we'll that the of that, collect we present we the data numbers their what between

terms and In just activity, the FLTX the of see patients. populations, are really agent than selecting single for want right, to broad you inhibitor a patient more it's of in you these CRs terms in threshold

saw responses, had forward. For is wild-type got found again, that jump meaningful to But and of is to move additional we patient populations, right we're one Bejar, now, -- group have different we in that that the Dr. a maybe on FLTX a if able forward. identify we a to like looking population and couple to confident mutations. too? the And track in those patient we instance, be can move would TPXX we that one mutated fast have for we you of FLTX, that that absolutely one mutation, several patients we're the

Dr. Rafael Bejar

I short thing success should your be terms that I and there prognosis. really the one of the to in those very of population threshold is, have as alternative what that patients for in context the the would Yeah, really therapies matters other add no think

example, For additional population second-line for perhaps Threshold you lot that in treated a have say, and lower therapy, patient than even previously first-line don't who activity. successor have [Indiscernible] is to kinase patients in where or inhibitors, see want with example, perhaps option. a any earlier been greater for

But talking we're who risk, karyotype on XXX worst prognostic -- those patients, bit been are complex quite Those will worst approved patient patients meet for populations terms a of of bar [Indiscernible] in mutant a -approved be have depend that. the who exceed their patients the therapies. truly and identified success to TPXX only it'll have some as we of So gilteritinib low FDA failed by hopefully will and and about. able

Li Watsek

you. Okay. Great. Thank

Dr. William G. Rice

Li., you, Thank

Operator

Go from And our Matt. Matthew question comes next from Cross Global Alliance Partners. ahead,

Matthew Cross

a Hey the to market questions follow-up discussion grants. about guys, good this continued couple fast-track afternoon related kind and for a to trying guess of of thanks One I interpret designation from XXX, the broader for taking me.

clarify, this on order of order you're base FDA on focus relapsed groups. what in decision of the a if -- to kind we guess what in fast expect that broader anything to to to see different to pursuing you possible you at or might of with kind wanted to or data was a Just trials able couple thinking guess, standpoint? from receive specific say, I that's patients the just like to extent that of able in it ASH, what And the tracks roll related other and particular they different EHA, about of a that was get it? of understanding at It idea up population they're a potential when can if point, that? but may subgroups few that had just discussion at kind potential AML you be Would pass, looking I mutation refractory granting what seen as expect regulatory though haven't regulatory we'll clinical a a consider of you of just point have on that to would responded the sounded seen

Dr. William G. Rice

through Well, the Thanks, for I'll Matt, try to filter these. question.

the broad market. of terms In

about what we the you first asking fast So were track, data have.

we've regarding data us. that we about A the those so a especially that of had fast then the failed at and patients very and we're FDA FLTX and doses, XX those were essentially [Indiscernible] as at that provided gilteritinib. as well XXX well-tolerated for at the talking CRs applied all -mutated, PR the we milligram And then the So the CRs had to and track many in. came the number -- had that disclosed

type. able this are the of activity, wild FLTX patients be move forward terms breadth for, to we'd yes, who -mutated, also to In but of FLTX love

the who those as so that's of include one able the to other drug the two-thirds, well-tolerated be of can. drug, FLTX mentioned, Bejar of in a are administration patients to and unfit third hope would that Also, This Dr. to unfit. this many you'd for is As be chemotherapy. the you to able as fit population, about target -mutated, we like so

little also to And something have do. truly up CRs. like the it of bit you we'd a that's longer but drug first path, if gets line that's well-tolerated Now toward that a is moving and relapsed refractory, a then and

the that will it who will in the data that's it are after. not get are to us we yet we're and all patients the have we are go depend have and those mentioning, that those track this ones with say these fast and patients reasonable we'd to pre but data able subgroups tell If But FLTX that, identify tracked. So who to paths able not in, data, was is broadly to and and response we what failed to after. as additional have adverse path. able in current go can and and that just believe regulatory the we go can after the as will data we're we we're again, other the those the particular, Dr. to go drugs. with these patients we're that. -treated are possibly these data as to patients take, the upon identify pull patient what those would see mutated, failed wild-type who doing entirely follow X mentioned to through fast to expansion mutations, need Phase to that in much haven't treat populations flip And enough those into But these trials. why can patients to even Bejar FLTX rate get that there path want we'll a gilteritinib pointing have Again, you midostaurin a like if mutated you the seeing Currently, been as we

don't the and take did mutation waste FDA. the data, Dr. your what Identify miss? patients Bejar, money to going wrong waste take profile. You after work, ones the to that I want else the

Dr. Rafael Bejar

for points very take a subgroups those in patients multiple patients FLTX that data. have path it since have we I fast-track, genetically going not be we with do genetically to susceptible identify They'll was responses meeting well that put. they're was was group choice another the would FLTX No, more obvious and forward to that to make that identified that that are subgroup. but once exactly

Matthew Cross

guess appreciate I were or just GX look elevating, I guys. me. scenarios the GX with beginning out patients XXX clarification one lux, you And then you to guess I gaming lux. noticed that the Thanks, possible with for milligram at work a on

from Just far XXX is whether to and the wanted those XX to GX which after basically still of be about what I so the patients kind PK equivalency. milligram milligram lux transitioning we understand have equivalent to think would gathered

dosage doubling the So and next in the the just wanted step, kind understand of for to there plan why the given potency.

Dr. Rafael Bejar

can, I Yeah.

Dr. William G. Rice

Okay, please.

Dr. Rafael Bejar

of being yet for that but about are terms really haven't they on comparison, GX dose of equivalency patients treated level as in versus talked GX on. the appropriate putting use GX, GX we we whatever a we're is So dose

is there, multiple increase on work. going understand modeling GX greater in going is So which exposures to be make understanding sure we required look it's not a to and get dose, help doing selecting that of the doses of The to us at how what to And to going [Indiscernible] to necessarily the reason the a that's better clinic. multiple proportionality we're seeing based the we dose. have GX doses also that as to dose we're with

will as pull GX go could we the a to. if XXX. on we based We date we needed vary we of the of continue to it, can So higher than dose see back

you'll So go down that's see one than that to going continuous GX road. dose feeding model justify there more that dose the is we'll as that then into to used

Dr. William G. Rice

That's Yeah. a good point.

here. mentioned you dose the So fixed

five these So person. for because or won't milligrams, get kilos instance, may we at four, XX three, have of you maybe kilo there XXX a some XX patients smaller

XXX. these on to at a what collect make XXX, in So that as move want be can is we fixed And the another We're can at very you going to a escalation. as well quickly you goes safe, up so patients good sure if exposure and as do said, patients we're sense a we'll of to a the modeling dose you to and going here dose have many Dr. move all dose. the dosing up if to then hopefully then then its XX, get Bejar continuous

that's plan of So the thoughts.

Matthew Cross

guys Thanks forward Look weeks again, in to with update. few at Raf. the and Understood. corporate Bill a talking you

Dr. William G. Rice

Matt. Thanks, Yeah.

Dr. Rafael Bejar

Matt. Thanks,

Operator

turn it comments. to I'd like to questions Dr. Rice back for this have time. more no And we closing at

Dr. William G. Rice

and All through be advance without though our shareholders of I We you the for this of continued up. this let's development to advancing to helping support everybody who and all your apprised investigators, good keeping thank very forward progress. it thank our Thank important and importantly, work. very our the Well, a you most none interesting afternoon. stage joining are patients of our dedication would possible the And wrap analysts have for we right. a of want look our company. importantly evening. us our of We're employees, and

Operator

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

now You disconnect. may