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Aptose Biosciences (APTO)

Participants
Susan Pietropaolo Managing Director
William Rice Chairman, President and CEO
Fletcher Payne SVP and Chief Financial Officer
Rafael Bejar SVP and Chief Medical Officer
Matthew Biegler Oppenheimer
Li Watsek Cantor Fitzgerald
Edward Tenthoff Piper Sandler
Soumit Roy Jones Trading
John Newman Canaccord Genuity
Call transcript
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Operator

Good day, and thank you for standing by. Welcome to the Aptose Biosciences Inc. Reports Result for the Second Quarter 2022. At this time, all participants are in a listening-only mode. After the speaker's presentation, there will be a question-and-answer session. advised now conference conference like Ms. be and being over Please will I to instructions] that is today's recorded to [Operator hand the Pietropaolo. Susan Ms. Pietropaolo, please go ahead.

Susan Pietropaolo

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

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

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

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

William Rice

in for and kinase to human the Aptose, greatest the our want our two oral XX, and focusing welcome activities second quarter are everyone of we've emphasize building our an developing I June are clinical our call can experienced inhibitors, into accruing XXXX. At we to trials significant toward XXXX. extending ended value that stage want runway generate the we're cash team Susan. the you, period I experienced and the capital Also cash Thank clinical distinct no time anticipated that fact, of in quarter. past patients while and schedules shortest to challenges during now ahead rapidly;

enough includes safe powerful these population adverse remissions clinical also it's AML patients. suppresses kinase. plus therapies populations remissions refractory disease That's AML compromised very patients advanced and for and deliver their cKIT highly diverse complete is XXX, validated KOLs, cell including and three the not having mild chemotherapy, drug targeted mutations the that other DNMTXA resistant patients diseased RAS, already range most combination X flip complex the single transplants, kinase so refractory MLL, impressive three therapy mutation and NPMX, a prior heavily including across well or the from our including mutated for to therapies, with therapy, is for disease AML potential new clinically kinase, It's our that inhibitors, to complete be as midostaurin or investigators, approved patients normal stem IDH, failed their patient just prior AML these this reach suffers responses approved mix of wall Our these It and forms FLTX as or genes, three Yet and flip delivered de-risk compromised a refractor by or By that AML earned myeloid in in by a XXX hematopoietic XXX patients the profile FDA. mutant mutations, the acute each highly and in why adverse having approval. disease, these designation patients physically therapy, it, cells myeloid are type on status. high have a and To impressive kinases of JAK to harbors be flip investigational of X failed clinical of having in the capacity to in us, excite is track wide lines with that RUNXX, effective trial. in and been time also a continues JAK sick and that each and relapsed population. desperate and of CRs others, therapy, therapies. physical by and trial, is the XXX responses and a is XXX to orphan a to is to we or AML kinases, XXX kinase the of our tolerated XXX is and of with drug the status clinical sick candidate, relapse patients karyotypes population date or advanced fast have refer to of leukemia all HMXXXXX relapse kinase, handful inhibitor the survival inhibitor demonstrated complete with TPXX, as therapies been with refer of refractory need accelerated our such critical enough its clinically treatment gilteritinib the failed selective participating AML but cells, the forms

to of the confirm increased accelerated activity AML defined are efficacy development, has The approval. specific two select defined of X/X populations in our and impressive for ongoing that just to populations. dose This and awareness is response trial already X and proven dose patient doses our rates and into value and sizable the broad safety agent and accelerated clinical trial. several more ongoing allowed profile to date advocate than target target has agent from next genetically and Phase Our plan in and data us address created which includes delivered then stage populations this breadth designed near for dose term trial registrational to patients exploration XX expansion involves activity of to this of activity escalation year treated being begin trials second clinical includes segue of rather for half one the populations potential approval. XXX support studies This that that genotypically to this markets, single than AML Phase by

inhibitor to studies, mutated and continued positive half choice and FLTX remissions to paradoxical profile inhibitors and got of our see our of patients been path combination this and market agent and inhibits RAS it suggest me mutated for on remissions defined Luxeptinib; already registration through to and pretreated $X MLL original patient the calculate while First, separate the Lux XXX. patients populations. it path, is a AML by study oral population, lymphomas more the Lux and opportunities populations potential But Dr. may overview Phase composite Chief heavily combination the to have important on target potential mild the in commercial It's additional as analyst during that billion, mutations will few AML Officer, with the the the other therapy broader these to therapy. call formulation use he BTJ, Plus with for patients have these now patients. provides XXX of kinases. FLTX studies for therapy with market when population let use for believe populations the with going target concepts MRD leave including an of studies the for we US their populations patients and see I the and plan been the exceed complete see in tumour rearrangement treatment for demonstrated AML mutated moments kinase the supports and commercial highly our development investor gratifying prior ample multiple molecule toward second, and patients. progress findings Bejar first and our patients. other how breadth dose AML leukemias NPMX and recently in expand two own will And of second and with additional already FLTX year, others move these XAB expand is genetically of cancer see to to clinical escalation on maintenance potential a Medical efficacy TPXX that market activity of as in has B-Cell the all annual through therapy complete to for agents mutated adverse FLTX RUNXX/DNMTXA with and traditional patients On failed initiated failed, and the the mixed newer safety powerful irrigator mutated trials we we

B-Cell original XXX level still cancer XX% tumor clinical of at signs observe or and to continue study we reductions recently observed relapsed activity Lux milligram the formulation fact, far. thus two on volume the with have BID more In patients

an also now certainly and months. trails. Bejar my dosage of from exploring but exposure we've and four In one moments, which Lux point, we've not lead levels of who studies coming the with rapidly different Dr. a And the we received patients know, final formulation, higher reduced been could the details dosages least. plasma improved optimization GX dose call to may you levels my As formulation, deliver which few accrued will GX in further provide

served recently, finance, month entire and to his accomplished completed biotech call. background Financial and to joined Syapse, CFO, Fletcher and quarterly industry. Let More new I through specific of team Payne a brings Fletcher strategy our development Fletcher highly go in CFO transactions experience his ago corporate and extensive he several corporate won't operations oversaw me Chief functions. as our the welcome Officer, Mr. financing legal accounting, he where first A Aptose here. finance,

say, heard introduce You to you. who announcement, by on suffice Fletcher? call our status. up our and I'm have pleased from bringing executive financial you can release Fletcher on will to congratulations start we're but the date to management delighted team today's his I've press to join him many to refer of

Fletcher Payne

XXX, Thanks Bill. of I'm you. I'm help to working already with to Aptose look Good Lux. some with afternoon to and met to advance and and working forward pleased all. be team you glad

the review second financials. Let's quarter

quarter, XXXX. has our you Aptose, the cash we management compromising As from into extend were to frugal activity. extended our of allowed cash XXXX approach that our into Last discipline most assets. direct take further and the and financial following cash reported we the without our quarter current a to of of highest Continuation us know, fourth cash impact the disciplined

We cash, That cash as to XX, in So let's March ended review of decrease with XXXX. June $XX.X approximately XXXX investment. million position. XX, cash $X.X compared and a equivalents million our is

net loss period comparable the per in translating and XXXX. from down the from During $XX.X million million approximately into loss loss quarter, share approximately $X.XX the was $XX.X

per share months $XX.X is During and approximately ended the period million six XXXX. comparable down into the $X.XX from loss the XXXX, loss from in net June approximately loss $XX translating million XX,

as XX, As statement, development identified in of month formulation, from Research down XXXX were during during ended was costs. million the development a G&A result G&A of million. the primarily to $X.X XXXX, expenses for of of XXXX. the period the in for The of same as expenses in Lux million of lower to for million for six approximately due manufacturing decrease income no lower $XX.X The from million decrease million first revenues reduction period, were $XX.X cost XX, and and second the June period, the compared approximately $X.X the due quarter million. we compared trial quarter relative and compensation for the was were quarter API six million million the GX $X.X period quarter to of the $X.X $XX less were the half a during $X.X to down ended June Research decrease XXXX. XXXX. $X.X 'XX. which with clinical quarter month had same requires the $X.X XXXX to a for decrease comparative million as expenses stock-based comparative

$X noted to uninterrupted. per me it price the off continues below closing trade Before update, consecutive that was Bejar Dr. stock from letter asked you share of Aptose stock NASDAQ for the I about days. XX to bid company's some turn minimum for clinical

an matters many compliance company minimum the with above NASDAQ these As stock the a when of considered $X to know, has XXX the minimum closes you bid at days for price regain NASDAQ closed time compliance requirement. or XXX-day eligible XXX-day business additional regain not days, may and period. receive the during of any company period, If day the still period. does within we be that XX XXX to consecutive

through implementing contemplate brief higher let's Lux us any and drive too stock a Bejar programs commentary asset the it's topic. specific believe Dr. to to strategy increase key XXX on other and actions that, is awareness this and XXX levels price to Our clinical With its advance We early both Lux. Raf? to data achievements. XXX give to address clinical and have of

Rafael Bejar

have has of you the and hematologic board. Thanks well-differentiated Fletcher. for B-cell malignancies to treatment inhibitors cancers. distinct AML Aptose both on AML for kinase for HMXXXXX It's great two oral and very Luxeptinib

Let's which for validated has multiplicity kinase ongoing start with asset, is myeloid with AML remissions lead patients clinical that inhibitor our trial Phase complete the mutations. delivered X/X safely a our XXX, clinically in of adverse already

While XXX a forms FLTX. all is it inhibit more much inhibitor, FLTX than does of

with a look We currently and competitors and studies, inhibitors. anti-tumor treat used best-in-class agent to that believe XXX Venetoclax FLTX FLTX FLTX superior let's patients in activity, combined preclinical So at consistently of may XXX superior In when context as inhibitor it the with be single mutations. azacitidine. AML a demonstrated

and understand While has because is kill may activity evolved. profile to the to XXX a we to ability that same better targets AML safety. with that breadth pathway FLTX be a of resistance. compromise for begun its with FLTX the pathways positioned development that by inhibitory XXX time, rescue kinase inhibitors to superior At XXX, competitor inhibitor lead of interfering of resistant clinical its the avoids have competitor, to clear cells

this of in recently, fast the quarter, second designation refractory XXX that patients from treatment the we responses XX XX acute rate of with of these the population, which milligram orphan show relapse In treated the failed have treated dose on XXX analysis mild the have FDA XXXX. received drug and current FLTX among treatment XX% dosage milligrams has patients emerged previously dose mild leukemia XXX designation patients leukemia other have additional been who or milligram patient inhibitors, a track mutation. for During with More for It by placed granted we already the FLTX Most FDA achieved with response at patients or acute level, patients. XX of levels. at the we to greater.

of we Although higher treatment, course patients levels. for the will at they are early watch their in these in responses dose

begun patients lower can identify we've that to responses. XX limit addition, dose of the treating at the doses level milligram In deliver

complete agent that to it AML a say heard KOL a It's on as give While relapse a this in need. even agents activity patients, response is the with extremely XX% with you others, some is additional response population. dose evolve response event rate number important challenging it population tremendous will studies. it a the common rates single a other in To we that in patient Dauer you Jonas demonstrates this medical trial, unmet in Novel Brian our be significance in [ph] those and who twenties many apples response get can not in rate, of of This our investigators teens to Dr. rates participated as to event and June, very refractory remission as patient meaningful. apples in Dr. compare the well how important when context comparing highlights from to other

care XX%, pointed Dr. the gold refractory previously single agent initial standard inhibitors. [indiscernible] to having though of been FLTX most in patients relapse is even had with Diver of the treated rate fact, an CR not about In

adverse significant to by the more serve treatment. that [indiscernible] response resistance inhibitor, that I quite multi-drug conferring activities the is that patients also as it's those previously the has group. the to inhibitor, with c-Kit concurrently patients for have FLTX we've prior mutant contributed even JAK one our as in in and mutated and to that multiple is this have in XXX explanation to ITD additional in as and/or mutations have inhibitor FLTX inhibitor about the therapy serving failed population highly is of AML, midostaurin remissions likely proliferation They with So patients treated MLL-PTD. and mutations including One patients and patients we've FLTX rate rate with as NRAS, the PTPNXX, gilteritinib, the diversity that in mutated sick to and and types kinase highlight in responding both inhibitors and a complete potential more KRAS is the FLTX been mutations FLTX pathways want well mutations have but in that FLTX than relapsed had impressive. seen very other a had responses. and in tablet FLTX, mutations, of included These TKD activity in that study a the response include complete inhibitor a indeed be that X/X importantly, suppressing RUNXX

Some of XXX. be resistance to that continue to inhibitors, to these tyrosine associated are kinase sensitive they mutations typically with

a who along in that FLTX patients Importantly, type patient with a a mutation. genotype, we've one very remission. carry seen had patients prolonged particular, wild and very TPXX do genetics, highly complex not adverse activity a in also FLTX mutation

IDHX RAS event, patient factors. at KOL XXX can with I As experienced Other a mutations inhibitor, Rice. a Again, patient mutations had in likely that can't remissions to with than seeing splicing and with our various treat identified get Frank a is by that reinforces FLTX populations this remember commented ever principle and patients agent CR chromatin XXX that a and complete TPXX, a by earlier TPXX mutation. the more single Dr.

QT seen change particular, elevated relationship creatin dose. adverse and inhibitors. seen and and the deaths adverse other Now effects that drug-related have we and adverse not our not last any the any XXX. we've related no let's kinase to seen update, serious of about events between we've observed had have not events, related QTC prolongation. we've to talk dose actually safety in Since not types kinase, severe no In briefly affected we've drug-related events limiting And

dose muscle a window of in dose begin the have half due milligram levels XX dose order our by agent milligrams with that have dose prior planned plan level. we to dose selected study dose expansion been broad of It who to to breakdown, bracketing dose this as designation a up safe in Importantly, doses We We we XX, adjust as XXX response the XXX have and These explore rate one have of that our failed expansion inhibitors milligram will second as we otherwise no options. patients supported level, significant our would refine milligrams not XXX rate identified not single if at now dose in spanning FLTX while to medical range and are the the year. the muscle path the patients The was to have transplants, mutant milligrams great do date. as and forward send doses FLTX through approved therapeutic to necessary. limiting with believe we these patients and can by our fast XXX primary a need toxicity we toxicities shelf to several take in we've with ability Rhabdomyolysis. known therapeutic to registration. weakness milligrams, limiting rescue a to which allow We've us to XXX quicker them selection, perhaps had off done and and any unmet XXX this

also have as with We such adverse refractory TPXX. patients than mutations FLTX and or other include AML relapse un-mutative genes

and Venetoclax for these accelerated meaningful other options single both adverse other and XXX will lead to We identifying as with with safety approval. activity prognosis agent subgroups explore treatment, and patients in activity in could that combination a

will agent activity understand treatment a of lines simultaneously will of therapy. how partner best Venetoclax. use the explore help in define While combination we to of XXX we This as us single earlier treatment XXX, better in

this on development we and subpopulations plans as trials second to these begin trigger path. these accelerated available sufficient corporate starting be expansion on leading soon in website. year are to will data conducting in collect XXXX, registrational the clinical outlined presentation throughout July anticipated that These the We could an of half trials as

Okay.

review Now of quick on to a Lux.

failed that Just often both who known various XAB precision and standard Clinically, Lux therapies or as or potently It risk AML refractory is Phase with with a separate toxicities. have are in intolerant known far as and spastic high BTK reminder, drug or trial the FLTX, clear relapse avoids and is with trial the in patients inhibits relapse only in BTK thus associated of patients agent engagement with Phase in important both has to a B-Cell that malignancies target anti-tumor syndromes. a B-Cell malignancies. and being refractory AML activity tested targets and clinical well that the mild XAB demonstrated FLTX

these However, has been consistently using not to aggressive levels treat the it formulation, absorbed achieve original enough of well and cancers. effectively

with which that As we've prior, across mentioned formulation exposures greater new enable GX progress significant we patients. may have we Lux, of call made our

Modeling ongoing plan the transition formulation This formulation. us to clinical to data GX because plan to a After new are relative and a the completing trials GX submit all later to then a for plan a XX dosing we FDA the point, times through example, of exposures time deliver comparison. is of of basis developed and continuous milligram action for GX escalation may If modeling and year comparator patients the dosing original with in the necessary that an collected GX, the up in of compelling, levels GX likely single continuously to exposure receive it's milligrams GX to our administered continuous at four dose patients patients. the to this to reduced formulation dosing away XXX higher report Lux per in we I'm the have to dosing exposure on of evaluation milligram different inform patients the XX XXX As BK dose go GX then doses XXX to of malignancies. formulation milligram the two-hour from safely rate GX for will protocol significant our data dosed PK on dose patient. the GX patients QX if at approximately with direct plasma are pleased hematologic with represents level. levels expected samples dose towards transition and dose, the allow in

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

with our are to We Lux look we you and XXX the clinical keeping pleased in progress programs in forward updated.

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

let to it Rice. back please you, turn now, Dr. me So

William Rice

Raf. mentioned Raf really the we that event yet KOL in you have heard the leaders of if June Thanks in held you do and respected so. should these perspective not hematology,

can our webcast You website. the or transcript on access

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

Operator

[Operator Matthew come of instructions] question will Oppenheimer. Our first from Biegler

is Your line open.

Matthew Biegler

Hey guys. for Maybe Thanks with questions. on Dr. just progress. for off XXX. our Congrats start Bejar taking on one the

kind have were may you terms multikinase the potential, but in of to the depth of alluded as think us this responses. that patients unique something its struck that responses in got I of

looks go explaining than like you do it recovery like CRP Specifically there's guys CRI. more CRs about or complete that? incomplete remission How count with

William Rice

be there. may Raf, you mute on

Rafael Bejar

the No, heard, delayed. for question. Matt, I sorry thanks was

death is extremely of I important. think response

I not think patients suppressive. to who it that drug is and better do have a are overly like mild the demonstrates CR

patients limiting because to long those suppressive having may or a be mild can If other that a things. you still want to able treat require transfusions severely drug patients time, be for

is milestone. think in approvable recognized a an as marker It's unqualified the CR approval So is important also FDA as survival studies. for an accelerated achieve the that's ability that potential overall one I to surrogate

key. on their of that's a were who If had time, they that very amount drug happy in responses. see evolution a the to substantial patients they be over going we time were and for we response beginning, maturation have didn't the they that complete at think So of saw to to CR actually

morphological state, count that, which with free You're really response, type without called if quite that and that of just is outcomes may any only patients familiar blast the as clearance with that's good. with isn't unfortunately, this and response have, the leukemia state's recovery

seeing think complete glad is So I factor, you more this an on. response, I'm important

Matthew Biegler

you. Got

quick do forward decided traditional or just a makes you're good to AML yet you going before, Okay. Have you're be we would three going commonly able one -- reformulation a Lux on specifically NHL and get trial that hop away you a as X-plus like? some queue, Thanks. was the GX you the going three restart Yeah, might need also be a That And back forward? can know or do sense. this I'll to to taking titration then escalation accelerated did explanation. asset the but what of before Maybe you be to is it to going look in to sort going dose forward? a in with B-Cell redo think that of

William Rice

this take I'll Raf, So one.

or higher we to us data be daily So we final then the of modeling haven't suggests them on as be guide We're the to below any GX able just But to there. level. the the coming we'll achieving the to then where to exposures level, in. look continuous the us set FDA, allow and continue months, want now five dose that ensure different then the be with time, achieve able move the on the PK to once all forward. the until we'd make or Should we to made dosing, or how to should then But as data decisions and coming dose couple to If that we continuous data or to we'll likely we direction to GX, yet we at level again all get patient in modeling presenting go AML. see able it exposure an at data show that weeks if formulation, original request to under those specialist. be that to whether full is try levels, are it next And that the and we it's to escalate. not hopefully achieve the other may hand, if it four back may to have a micromolar twice dosing dose use like would of Those be which get forward. just pharmacokinetics. in to to then are are doesn't We we either plan and have, at decisions go. hope able in we currently at we move try But implement that, B-cells dosing we'll look able safety does the

necessity not would start over. to the we So see

So that but answer Hope thoughts requires again, question. that that plan, from FDA. be your our all Matt. would the Thanks, the

Operator

question from Cantor next Li of Watsek Fitzgerald. our And shall come

Your line open. is

Li Watsek

Thanks the us XXX sort guess if you guess, since And right that first questions. up XXX. give wonder the Hey enrollment that mentioned is for now, on follow an one I taking trial. doses and increased for can guys. higher I my two also update on June. you XXX interesting. thought that has -- follow I of was ongoing I on,

mostly the was wonder, June, the I then wondering you in and driven by that are out just start when put updates. next to data So you it data

William Rice

Okay.

So of I all understand there. was a bit It couldn't the muted. have to admit, verbiage I

So I'll apologize for that.

paraphrase can perhaps So you quickly.

Li Watsek

sure. Yeah,

the first question increased on up since the two mentioned is the you higher up, has right with and how now also So June. enrollment the the doses follow follow long is

the out was it when just and by guiding then So you to data is I the driven data update? just next wonder, you are put

William Rice

All right.

on start can those. I So

up. So the link follow to

the kind did I of XXX a, of what level. XXX the had mention wave literally coming So into study patients on is the a and we've milligram

Behar Dr. milligram level. XX as the Now, also beginning at we're mentioned,

a time. these just we explore have lower amount can of trial of the there. on been patients short So Many for

early are their treatment. in they So

present data now. those right we we have so can any patients on And really don't that

calls, going we the it come have we months. out next over as those. of or be As We're a will and opportunities, soon number conferences, do, of banking, earnings couple to whether conferences provide

to that you definitely information as get able So to be out emerge. those to want data we

Now when TPXX single Especially and everything see based on They of in lot talked a get event accrual, of a why increase? patients describing complete and they don't we a patient get that. field failed diseased that. patients are. was these the come of they to believe they out patients, mutated did KOL the it We have remission just on in terms it how when a presented the these molecule luminaries you about

investors, but are this. analysts, investigators, possibly also that believe as seeing we as the So only well not patients impacted that

our he add to lot seeing we've CRS excitement It about, he your as can they on want is. of Behar there the seems is, when be Dr. patients, really to as oh, well on come a start from drug. they trials, the that. Perhaps investigators So clinical seen the

Rafael Bejar

was made it back. totally I Bill. I No Sorry. I say, going to agree.

and I to expanding engaged think greater that with of also the number engaged sites putting the additional we've We're producing of very the expanding investigators in about very study study the spots have a patients. been that data on the number been and responses. we're anticipation the of that with

both by to engagement we're getting greater board. greater of So by in helping that on be sites are going enrolment and also getting numbers

Susan Pietropaolo

great. Okay,

seems second while are mg. guess of dose question XX the it is lower I the So like you exploring

can on you maybe was potential like, little or considerations? the comment any wonder, maybe just So bit by the combination FDA a it driven discussion rationale there, with

William Rice

Bejar Dr. can this. answer

Rafael Bejar

Yeah. That's an excellent question.

the Because single of cohort. exposure exploration we in studies. Phase driven patient XX a It's the an that the it had FDA. exposure had XX dose like at had that that average milligrams it part and we looked that that directly not accelerated on dose an demand a a job companies lot does was X where was FDA and do something saw driven put during the only So we the process, has that's out, escalation really that by milligram recent better by guidance something patient

patient of and our of the exposure forward we're justify XX more So is fully how doses we into better to we're XX that order carrying need milligram that in milligram left with to a terms expansions. might question versus different in explore

to of we study, we'll to redo when dose fully So milligrams back to later there. time we that XX opening doses, that the we come the studies the ensure where put better see the continue expansion us those to patients FDA and period since actually it might cost ongoing perhaps explore and a these of have figured at few more might PK would time we that between And on that activity the we're here a ask us levels, understand take time. just to exploring the

William Rice

point. that that other FDA particularly given guidance It's direct the trying great question just the There to a was on or companies and they've no follow recently. interaction from that. But

Operator

Piper Sandler. Our next Tenthoff of comes from question Edward

open. is line Your

Edward Tenthoff

very kind you have for Thank much of questions. Great. too, my clarify. just I taking a to couple

new on presented response discussing, event respect the XX% X, you that denominator that is because you're rate with to June what So the what the that firstly, or is out at I'm trying is?

William Rice

So I'm Dr. he take that Behar, can from hear the not do again. sure you patients? want to seven

the and CRs, done and the We've those patients that FLTX failed that. a who were level And that have repeatedly had provide seven we PR asked that the response. were inhibitors. FLTX mutated derived So that are response there numbers that had some that patients rate. previous and had Two we've so been were to three was is that of one to data related

Edward Tenthoff

Because FLTX CRs of I really the mutant, right? and the in one it PR, three and the out saw the you, CRI four was seven that the so two

William Rice

Yes.

Edward Tenthoff

little up that So showing second question, this be about yet? was Raf on bit just exploration new that saying. what I recognizing expansion won't to ongoing this up XXX dose And question, mg. He no? missed last data the be generating of more you or breaking data a to year, Is still will follow later was cohorts escalating

William Rice

second the want Behar, I So take part? part Dr. to the address did you can first

Rafael Bejar

Sure.

reaching XXX milligrams. about part first The the

William Rice

Yes.

Edward Tenthoff

Yeah. I missed what just,

Rafael Bejar

levels exploring efforts go milligram but further dose instead lower lower with treated instead focused do to dose having we there have not could dose dose XXX, focus we needed, encounter the dose any at dose exploration. level. the patients level we've the dose level We And that the ability there to be on our We to the do then the patients may toxicity treat if exploration. have moving dose milligram milligram higher we've to dose limiting and dose lower where felt And ability XXX dose on level at the to advantage that have exploring not may advantage we be we to So the limiting we higher the on did any to the in that the focused explore on where XXX did levels back encounter level XXX dose level instead times dose toxicity. level X.X the and expansion. in dose that levels than and activity exploration seen

William Rice

And could you DLT disclose Raf, [ph]? that

Rafael Bejar

what, I'm I, sorry. Did

Edward Tenthoff

was. DLT the what Disclose

Sorry.

Rafael Bejar

lower Instead neurotransmission. muscle was myasthenia it Yes. as rhabdomyolysis. like where both The And, and DLT had looked weakness, weakness. limb described phenotype wasn't gravis it qualifier It more there a that breakdown. muscle there's upper I that less added the wasn't

Edward Tenthoff

for respect from data with -- then And the... this

William Rice

Yes.

take can that So I one.

that the placed are have on been recently, in disease their again, they patients from early or their in So early treatment.

And additional do the this those data this presenting And begin to half as throughout of XX. will and plan second patient plan the through XXX, placing we we we present do remainder year. So on the go there, possibly continue as evolve, that then on throughout additional year. XXX year, those data to of we

So not do we plan until the not going your question. we're of year, the on waiting that's to end -- if

Edward Tenthoff

how arm split then on Okay. one two single many arm And patients one, do you the last event arms Thank much, in envision with so with many to dosing you you FLTX groups? you How Perfect. those mutant, agent Venetoclax? And that just showed are three anticipating type. expansion respect wild then of kind one,

William Rice

Bejar? Dr.

Rafael Bejar

Yes. I can take that.

submitting amendment from, FDA we'll we're each patients now just numbers but we the proposing an treat in are of that feedback smaller So to get from subset.

have subgroup prior three have mutant where will mutant for So therapy. three an even this for FLTX inhibitor one though armed we patients received be that

may these So that FLTX mutation patients be that'll the Then that cohorts. won't. prior of not be a be handful received in a meat patients will it'll arm FLTX one It'll and a be that single therapy. subset. TPXX each subgroup there'll agent have in a have of Then

the in arm compared patients number. of Roughly the will So the arm about we'll add up single to patients two the in to to combination a ratio one. agent be speaking, pretty substantial

be in agent as many patients the twice arm. it'll So single

Operator

Our Roy Jones next question from of come shall Soumit Trading.

Your line is open.

Soumit Roy

for thank be DXX do And patients you color lower burden you to [ph] patients would how milligram the are cohort bias getting you any towards into appreciated? assigned possibly dose different question. getting XX everyone. taking foresee us the any Hi disease other the or or in words, dose Could or explain

William Rice

you do that? Bejar, address want Dr. to

Rafael Bejar

that take Soumit. can I

One have will anyway. of the advantages some other that is dose arm begin pull to patients at looking we'll of to we back the where the have combination milligrams in with XX

So of [indiscernible]. better we'll have understanding the little bit dose levels of a

have, on going their of the course burden that could the it matter So that sure necessarily base but they potential to be will one are in it option. we're on patients not I'm the where disease treatment. that

refractory in mentioned may other therapy dose combination, need we of necessarily setting in So both to of possibility patients earlier perhaps where relapse also treating perhaps contexts besides the the the be but in maintenance disease, lines same. a not

better achieve So understanding if dose what will levels, lower of having can a help be. XX us understand need at we to

Soumit Roy

investigators expect or that don't you any patients don't go to get just patients could towards a dose to cohort, frail you lower with higher or put But see to more mutational CKPD bias this arise. burden

Rafael Bejar

I see saying. you're Oh, what

Soumit Roy

don't I anticipate that. necessarily No,

patient's of level the the the I time. on, that necessarily a available them that they're choice when I don't appropriate put they think test biasing at patient the know to based it's to see for on study likely in general they're them

Rafael Bejar

associated XXXs the higher the haven't between we eighties the with levels seen And additional and toxicities

Soumit Roy

that's guess I welcome. you. Thank see. I

because or patients The second from treatment of you have to natural would question endpoint median would with be going respond to response if CR you if of so be directly, the of the transplantation a sort into course obfuscate CR, patients be primary who like discussed durability get guess is pushed could would potentially progression transplant. the rate I how to and Have would stem for [indiscernible] point approval a up turning that's CR, would a or would later cell would most OS FDA, look into would be that like coming of time XXX. they just bring

William Rice

we of transplants lot think know, that's I don't the population, necessarily stem case. in seen have but I cell a Yeah, patient always our

necessarily necessarily. to they We and patients CR transplant, Many especially early win a have older that academic absolutely clinical standpoint. tremendous have transplant of medical said, patient, into might will goal. getting we disease a our as experience centers, the transplant from for eligible expanded that sites, a the clinical of sites But go capability. large is don't and where relapsed a them a bias know a to with for I more refractory themselves. that think recognizes that it's majority more be and not in I considered FDA And laudable a transplant

the patients accelerative drug they that may that approval before go have while transplant short durable FDA or will to remission, do there. to and and patients a be part who was on and where the study, frontline to I many work combination the have with transplant achieve they example help companies think the quizartinib including require to process the the that count drug to transplant went the in but assessment that of they for entire So remission, exposure, their not the the a of that of meaningful Recent patients therapy. is only of had consider of the transplant time counted arc

Operator

have from Cannacord Joshua question [ph] we a And [Operator instructions] of Genuity.

open. is line Your

John Newman

Newman John actually is this is this Canaccord. Hi, from

question follow expansion a on cohorts the had up XXX. for Just

would for looking as I as patients at response patients. wondered mutated well be FLTX if And think milligrams. mutated Rafael a any I XXX sure those higher also we'd be milligrams transplant, the complete different if for XX I be cohorts. the heard terms in TPXX that after approach you stem and then of dose at Not looking a say you'll cell

leave up or to perhaps transplant. that to likely you patients just to that you would recruit be would be If for continue if investigators, less would the eligible

as curious about Just you're thinking to that. how

William Rice

questions. good both Yeah,

So going just we're single start expansion agent the with. the milligrams XXX to to forward is that carry dose in clarify, to

ability to patient dose fact, intro they the dose an isn't do response tolerated the a ability dose Meaning include they've up we'll XXX to to move milligrams, ability at appropriate have and a assuming escalation. milligram that We XXX have that if well. the patient getting in move

toxicity be able if course, the needs us that there of to have milligram adjustment. if dose, should appropriate and that a dose more patient available We is whatever see experience starting make drop for be the the XX or we to we'll reason, dose to that with

is be XX, as candidates that far specifically transplant, trying age, open transplant. over patients of really that to to study for the for good are any including patients aren't to recruit patients unlikely As eligible that are

those see So for those a assume CR duration. wouldn't to in We have don't enrich better efforts understand that if do that order be transplanted. in patients patient we populations, to patient would specifically we any

I up think specifically to necessarily But the and put open that transplant. they're we leave leave study. don't investigators as to the think for I it are patients it they on will eligible who picking that

John Newman

that dose also want you Venetoclax? mention would the with select you Do Okay. combination the plan about to you for to studies

William Rice

Yes.

they purposely combination gives two milligram, for with have one not I have perhaps margin. as the a the before, XXX we dose interaction planning and expected between XX the and together safety to more the of that that mentioned us bit level any start understand the a in that dose wouldn't study, the level just below pull safety we're So, the back us dose to margin combination a gives Venetoclax. order to toxicity milligram of there, And drugs little might

understand be we if will lower to have experience we having expect the us We both and need up dose. went down what as more at that help XX will ability if a again, well, and might adjust to

Operator

Rice Thank to that Dr. And you. will closing back session. to like I conference Q&A end for remarks. would our turn the now

William Rice

Well, everyone, thank you for joining us this afternoon.

look tell appreciate today. exciting Aptose the our so we're a important work. earlier, XXX to us, continues our to to we seen look much patients enthusiasm this on and forward year. with progress accruals a resulting what of deal program. of for a our -- That the for investigators, called thank we our be analysts. have and ahead just our of investigators wave you recent being and pleased team, to this particularly ahead Although trials. their still the time have I clinical for momentum our shareholders we great of updated and here progress We And the thank say want keeping And patient work what and we to gratified we've in we're want everyone, onto clinical our patients help for promise the in really support by We

Operator

you conference today's call. for participating. all concludes This Thank

You disconnect pleasant a day. now may and have