Aptose Biosciences (APTO)

Susan Pietropaolo Investor Relations
Dr. William Rice Chairman, President and Chief Executive Officer
Gregory Chow Executive Vice President and Chief Financial Officer
Dr. Jotin Marango Senior Vice President and Chief Business Officer
Gregory Windsor RBC Capital Markets
John Newman Canaccord Genuity
Matthew Biegler Oppenheimer
Matthew Cross Jones Trading
Pasquale Sansone HC Wainwright
Call transcript
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Good afternoon. My name is Chris and I will be your conference operator today. I would like to welcome everyone to the Aptose Biosciences Conference Call for the Second Quarter Ended June 30, 2019. At this time all participants are in a listen-only mode. After the speakers’ remarks there will be a question and session. you. Thank Instructions] [Operator

this may reminder, recorded. conference a be call As

Susan to go I like Ms. Pietropaolo. would now introduce Please ahead.

Susan Pietropaolo

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

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

we to Before call remind that certain and within proceed, Forward-Looking the U.S. include Laws. this during everyone Canadian I would Securities of meaning like statements will Statements made

is regarding events, and and current to statements results that differ materially not from possible performance performance, Aptose's could Forward-looking those actual differ it uncertainties achievement stated risks, but may known that future involve reflect cause expectations. They results, expressed. materially actual guarantees expectations assumptions are and these unknown and of from performance and

are learn Annual this made. by law. revise uncertainties, set only as of reflect statements call, most as required undertakes after filings. during about forward-looking Aptose's this read XX-K in forth except the the Risk recent Factors All To risks date on SEC update the please no and obligation circumstances speak to these made the at or Aptose they or events to SEDAR statements Form call date Report and of more

call CEO Aptose Rice. of will over Dr. and President Biosciences. now to I turn Rice, the Chairman, Dr.

Dr. William Rice

special the June certain of for too XX, welcome we new shareholders I'm the ended some quarter our welcome have I to our to call wish Susan. on today. you, to Thank XXXX call and a whom second everyone

his Marango like review our Jotin newest recognize on the Management with the joined today will would of to Officer. call. Chief of questions first be both Joti and is answer us begin I Senior Team, June available we our the of us the Business Vice President Dr. Senior who end in and Chow to member earnings as quarter and participating call Greg the at second Before

you with hematology prior focus the analyst handful particular upon He was Joti and on research oncology therapies. one covered and with where were had and molecularly launched his epigenetic As to the particularly joining know companies a of he senior is research as targeted Aptose most of Aptose, universe. familiar which he of we during biotechnology at

his Waxman on his greatly as delighted Foundation team and also and of New join his him to Wall received PhD Joti's in Prior depth of degrees our are team. complement from Mount Medicine Operating the Cancer he to MD served we York. the in character culture have corporate experience our Chief and at Street, School and Samuel tenure existing Officer Sinai

first call of your to side Joti. conference on this welcome the fence So

Now let's time Lymphocytic Chronic Phase class an with in with entered Aptose intolerant including in evolution clinical lymphoma have or now pan-BTK and that CG-XXX X-AB inhibitor therapies. in begin our failed and review dose standard study beta two or Leukemia dosing patients exciting a escalation has pan-FLTX, malignancies differentiated CLL in of molecules well the first development. small our quarter. our estimates non-Hodgkin's of

clinical or inhibit for patients MYC can expression currently Myeloid AML MDS our stage oncogene XAB Syndromes the APTO-XXX MYC that a driver in cancer of Phase cell or the directly proliferation. and molecule is inhibitor major trial Myelodysplastic Leukemia a with know of Acute only

your financials status date the to as will to on these and as On programs, well you questions. today's up bring open call call the you brief clinical highlights both quarterly on other of we corporate then our

with call it. will just I So CG-XXX or let's as start today XXX

driver FLTX all non-covalent potent, of forms kinase of the and highly BTK systems. Our inhibitor

BTK and mutated inhibitor Although mutation we FLTX of of and plus known a typically forms multiple refer type agent, and be all it FLTX it as targets mutated BTK, associated viewed inhibits that wild as agnostic with all and avoids totally a should to because XXX precision wild hematology toxicity. forms yet it pathways of type malignancies, suppresses with operative oncogenic in signaling a

this are not compelling at the is clinic multiple excited pathways, With rely has attention FLTX ITD the very the mutation mutation CXX-XS finally one captured space dosing to pre-clinical target. of in XXX of rather we just to patients in of and particular initiate the treat be of diseases only is designed results that XXX. compensatory in treating or with long BTK. awaited XXX It many and than directed on the to drivers the

designed The and X-AB is multi clinical trial preliminary X XXX dynamic pharmacokinetics efficacy safety, XXX the establish Phase to and of escalation tolerability, center to the Phase dose. open pharmaco of responses assess recommended dose and label

of an titration daily for administer patient calls XXX each protocol required in which XXX and unexpected the testing effects accelerated mg XXX dose two those mg necessitate clinical first one at Our levels, at we side only to twice levels. unless are to additional

in increase is successful for the of XX-day completion way were chances an the dosing cycle the are pleased with progressing. choosing the the the patient trial in first we only of especially patient diligent and with study We now effort one to

in patient July, X-AB oral of dose the XXX at we idelalisib, in a venetoclax, daily. and dose XXX patient the so announced BID of had very initiated Phase pretreated. heavily patient starting dosing escalation ibrutinib, This our twice rituximab or failed clinical CLL is of trial we As milligram

no net the first patient from first we of steps As patient, Cohort the SAEs. of today XX has Committee that Upon the have cycle review dose completion will received Review trial. XXX can the the ADE Safety patient and drug of with results we determine or report doses related received of of this the reports than the more the

three including with XXX the each XXX to three doses The bar planed XXX, BID patients milligrams plus recommended a milligram patient dose lymphomas. refractory the dosing relapsed three cohorts of determine BID we in CLL and scheme receive and intend will to second and follow XXX then the oral non-Hodgkin's for desire sending patients XXX,

and identified a X biologically expansion dose patients active dose recommended as that or safe Once an to be phase up the XXX and been at has treatment may our dose. Phase for enrolled MTD

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

For more clinical may in visit on trial you clinicaltrial.gov. the specific enrolling information the sites patients

hope high to observation ASH this level American December. prior our also perhaps call. may our in data But So how of trial, present early Society have abstracts or ASH to from quarterly progress including we submitted conference early meeting findings to and clinical will we and the data we or first Hematology report on be able report next

pharmacokinetic and in allowance FDA collection escalation move data initial trial. humans into Phase to pending from safety that and X dose or to a the and factory in cancers data separate include the of in Finally Phase predictive from X the patient relapsed trial plans patient population seek with the careful review MDS Aptos B-cell AML

DLP vivo And during will data toxicokinectic Association at profile. present anti-leukemic and EHA and at XXXX data is EHA the that XXX En remind I preclinical mentioned presented highlighted XXX Amsterdam. supporting that we you meeting quarter Safety efficacy of I we and now relative a the poster in the European Hematology

tested median halted, of the After XX-day resume tumor Gig dosing In but AML, genograph Migs throughout XX dosing doses leukemic period per the Gig human XX lower restarted. is leukemia all per XXX when again a preclinical with treated doses XXX of dosing. and and suppress growth, Migs growth responded was

XX-days in the of even XXX. XXX% retreating robust of per XXX mice of tumor or additional an five demonstrated treated on the one toxicity of response for and mice XX of retreated XX% mice to two large these to neither retreated Mig XX were XXX that day dose resistance through day day through very all rapid XX XXX. XX better led rapidly And tumors Gig mice with the Gig, cures Also, mice in uncured the in XX we the Migs XX% study. resulting dose of in the Even groups of cured. per were beginning observed nor cured In responses in anti mice were out drug this can and one

showed in or dogs examinations, related weight XX-day weight, respiratory neurologic or as PK body Also, drug ophthalmic, we effects microscopic and and organ on pathology, studies recorded safety clinical GLP adverse no evaluations. mice

And separate preclinical a no or drug safety related cardiovascular cardiovascular effects Tox were noted in in XX-day the study. GLP

out Our industry space generated from post peers is are the BTK ready kinases in there aware there. and our interest as activity of a inhibitors particularly around you most hematology significant

here Joti development. in and other you comment of hematology drugs to from XXX like on the So, would commercialize differentiation

Dr. Jotin Marango

the agents My Certainly many the you belief one Bill, and and of oncology to agnostic in why part it’s differentiated in now and joined be is really I great of team. XXX Aptos. as hematology reasons a thank mutation

other wild both that type dugs of the molecule potently with and BTK XXX to the well hematology as ability forms FLTX, types of of in approved as a from as circumvent kinases of well this toxicity many development. differentiate The molecule other precision inhibit new as

of times B-cell cancer these studies killing for which would our standard on B-cell at studies hand malignancies. care preclinical certain potent lymphoma is have diseases all XXX available website. a our current average on other shown by way more On be the And the XXXX mix, and directly are improved

stage compared a malignancies which the XXX which FLTX more XXXX. quizartinib, XXX time, potent in times late of into killing inhibitor cell that development inhibitor or is FLTX gilteritinib was AML minor is At approximately same mutation in specific to approved

FLTX also in upcoming to trials. this, is common with importantly, cells. able to refractory India and leukemic tackle patients in type forward in all we AML Additionally evaluate or wild XXX look relapsed XXX with In-line clinical

well XXX capability and So, the target as the as overall suggest broader and across molecular the types myeloid different the both in that selected lymphoid oncology hematology tumor coverage in of malignancies. has

Dr. William Rice

Thanks, Joti.

As and best-in-class exhibits hope be bear that believe the trials to in in that continue ongoing voice out. Joti’s we hear the the background, sirens that to you clinical and potential our can XXX

safety Finally note continue to observe populations. that it’s be to we vigilant and and in tolerability these patient important

to new drug API manufacturing data, we We collected and upgrade and indications CG for for continue seek continue activities and PD XXX. to our biomarker PK we potential

to we these forward, to its the you update both transparent the on opportunities ahead. us as on continue in activities challenges all important for be will Going and

let’s XXX Aptos XXX. or now So to turn

focused as XXX among and our patient application initial MDS. development inhibitor hematologic into solid brought may is our have cancer mix a on and But know, certain As tumor AML indication. you malignancies

our being in ascending and X For in or then combination AML study cohorts to tolerating expansion patients Part or of XX-day is MDS transition cycle Two by AML MDS relapsed risk studies. design administered refectory clinical agent maximum Phase high with single reach. to is over The once appropriate the B weekly as of until doses dose protocol followed

each the first completed the that those cohorts. announced patient in we recently in of first X one two have trial dosing We only Phase the of two with required cohorts

Our of first meter received XX patient, Migs tolerated over once dose lowest AML XX-days per square, drug and patient the the favorably. an weekly was

MDS the Migs completed an XX-days patient well. tolerated patients the and over recorded those XX from of downward dose expression bio patient cells Both square cycle demonstrated XX-day week weekly the blood each second meter expression first reductions per once the a cycle. Our we patients their and as drug received analysis with also have during peripheral marker of gene and trend the MYC

which Further Our our and per proceeded XX-day is close we meter at adverse XX serious third square. to three cycle square to because completing cohorts, continuing Migs with no there third protocol XX our two first patient meter cohort were events patients. Migs second the now is requires treatment per at

XX completed week. per square patient Currently have two third with dose begin expected the first to a XX-day Migs patients their dosing cycle treatment, and meter successfully this is

XX dosing per patients completes at the Migs ascend the treatment with to tolerated period square, until will third XX-day is reached. the maximum meter no Assuming dose continue DLTs

dosing expected square. level Migs next per XXX The meter is

for sites cohorts. number and screening dosing patients We have AML a actively for of next MDS clinical the

those you enrollment the more interested trials in specifics of clinicaltrial.gov. about criteria, learning please visit and For

X line a We trial. when report XXX new this progress by We answer label are we open we will and the is data. an the questions trial and pleased fine Phase call of about want to

we to in XXX hematology of continually tumor any anti will acute pharmacokinetic safety and activity evidence of addition assess In information, bone marrow lukemeas for and MDS. and by evaluations

quarterly reported select to we CG important present level ongoing able about And observation expression. at of and our the with expect at high hopefully from trial and conference data core at reduction of to plan already we APTO-XXX next gleaned Similar PD to be clinical XX call our ASH. data share our mix our have to

be that To clinical in XXX treatment up malignancy effective are product wrap then therapies we hopeful options. patients treating our both be pleased of testament on patients prove candidates, for to to greatly are will XXX and with need new and hematology

around the early year. you of We clinical to have do ASH. expect to time updating forward data Indeed, we look in the

collaborative drugs several As to compound. have abstracts we investigators in for clinically mentioned addition our both submitted and preclinical we related abstracts

to I quarter. Financial call the turn review will and who Chief results our now will Executive President Chow, the over Officer of Greg Vice the Mr.

Gregory Chow

Bill and afternoon you, Thank good everyone.

of Before financial XX closing also their million In purchase into the I common the news shares by quickly second quarterly underwriters like additional public June, the price go included we a of get of the announced million common share. the would full of over shares. per quarter. options financing the $X.XX to some I financial exercises X. of to The the highlights for offering to X

and were the underwriting deducting The approximately proceeds gross million. before the from discounts $XX.X offering commissions

offering them this completed support. have their institutional quality we additional investors for and thank with We

last entered Aspire our up into quarter new with in mentioned shares where we is purchase common to in As agreement we of million our up Capital, committed of to the to $XX call, XX-month discretion. at Aptos a for Aspire earlier

Additionally, as million $XX and To Canaccord Aptos distribution Piper for sell with At and shares into co-agents. ATM Genuity or of a issue common enter The through we NASDAQ. ATM on agreement Market new Jaffrey

ATM This about accessed can under vehicle price be previous the of company that had. sold number shares financing Both ATM question and to of the service be us the any. determine the we if and time, these replaces

$XX million and million compared March $XX.X ended equivalents We investments with cash XXst. to the cash at and quarter in

In the $X that exhausted stock public Capital, agreement during raised proceeds we the from to the million also Aspire purchase to offering a addition received common quarter, with which agreement.

provide cash million attributable activities, which Company the and operating on with half XXX activities as into and general cash-on-hand operations second well to committed During XXX sufficient and Based Research surrounding quarter operations of were of current Company purposes. approximately the fund include $X.X the administrative capital utilized as we XXXX. in planned Development resources and all to

development quarter quarter. costs. Moving per had expenses quarter phase. our clinical $X.X to the including Research the for and the drug we XXX clinical for share. expenses and statement, to GMP clinical loss including on income XXX Manufacturing to for product quarter revenues of and development $X.X million attributable no the trials continued and and for G&A $X.X of or were trials $X.XX cost for or and net toleration and million headcount personnel million and XXX supporting XXX activities the research manufacturing were our was trial the

EDGAR now More our can over on information I Rice. call the CEDAR. detailed be Dr. in will turn filings Bill. found back and to

Dr. William Rice

I hopefully questions Thank for you, all introduce question. Operator if questions will the now the to first like would for us. and could, have you of open you Greg. call please three


comes Markets. from Instructions] Gregory [Operator question first RBC our the Capital And with of line Windsor

Your line is now open.

Gregory Windsor

Dr. thank CLL as space in in Hey certainly the of Marango emerge and going just little and now is data mutation how your wanted to to team, and or of hone market the the your wanted you for Thank and XXX and agnostically just affecting new perspective as all I the experienced on further progress revisit and selection I otherwise, is ask and on this and differentiation the my profile the you. to gaining patient perhaps Bill and and underway? after congratulations that just a mention in that differentiation your XXX questions. the B-cell in BTK and XXX patients on evolves Bill, start, now taking clinic. that mentioned trial you I

Dr. William Rice

to you. for Greg and it’s you from thank great hear calling Alright,

jump would will ask the in. I I to Joti also question, then out answering start So

and all, the of FLTX of Track inhibitory of has profile, receptors, the and atypical course there. the but inhibits inhibits in So talked a the alpha receptors also neck FLTX as first it inhibits we very those CSFXR for have forms BTK, also of kinase about, all are forms XXX it PDJFR are it clusters all red related all

all initiation BLK the as BTK, the clusters, cells inhibits to kinase, of kinases signals able oncogenic well does intercellular are that pathway, the kinase but cluster, to lead tech SIC, of BTK as (Ph) those that often TEC It specifically receptor through [indiscernible] inhibit not [SARK] the the the driven clusters of it for it's the of inhibit those some also at in can the toxicity. So SARK, surface. instance B-cell the

separately after now be then because it aid, so are specifically at inhibit it’s (Ph) try MIC. And to does concentrations, important companies higher affect kinase is oral going to the less going many to [oral]

that inhibit of these kinase So these we do I about. talking pathways,

the of some issues and kind FLTX the And those driver are BTK. of

we oncogenic of the the the AKT But B-cell also SIC kinase MIC, pathways, some pathways, those the pathway. other suppressing inhibit signaling receptor

different this molecules So view very there. as from we drug other out

but whatever three instance, kill just earlier are the actually quizartinib, want and we not know and to along. are disease we want additional comes targeting and cells to FLTX, we form by treat pathways. suppressing gilteritinib mentioned the had For Joti and you for FLTX compensatory But and inhibit those inhibiting targeting AML, the

same cells. but The CXEXS the other wall true pathways the look type the too, we CLL, hey the type But we BTK. arena. we if inhibt drugs there, the inhibit at wall are and kinase. B-cell the also do Yes, and in in some they them Well new of of some again malignancy inhibit out is those other inhibit you

a So to just the are again, target. treat trying particular not disease to treat we trying

have view it truly many or molecule is our others. that why as this and target that differentiates from we So in to cases, believe we agnostic mutation

just have don't or is to true And B-cell to can AML lymphoma, allows have mutation ICD after patients restrict MDS, not. refractory a that those the - it relapsed, CLL, all, we Patients or after for various non-Hodgkin’s go FLL, all go they patients. same MCL That to malignancy. down driven we whether or FLTX, us the a with have

of mentioned on the And ibrutinib, the venetoclax, first our patient drugs, even if you CLL to variety rituximab they failed a had PIXK as well failed inhibitor. I trial as

after can types believe we patients. So those we go

it having to turn So he I'm Joti of that. on said over thoughts I'm all going that, because additional sure has

Dr. Jotin Marango

you for nicely. very thank it the Bill up question. and summed And, Yes, Greg

development. side. specific On ibrutinib approved target the Greg, there are disease know the stage that in two leukemia quizartinib both acute are you and (Ph) late [mitosorine] and positive agents FLTX as

FLTX are these with indicated However, disease for all aberrant.

However, what effectively, type is our blast and have target wild as that studies in to well is aberrant the as to we that agent preclinical able XXX have seen a history. history

So interpreting and the this to all market AML agent. be susceptible this clinic and looking forward to to should the really

side. Now lymphoid the the BTK. same true is Targeting on

We which the opportunity. emerging disease, presents and disease testing mutation, treatment, enough presents heard about have of commercial this the clinical XXXS certainly subset ibrutinib posted resistant

the with that data cells However, preclinical targeting what as the basically. agent cells are [indiscernible] as well effective as shows these the is in

that and CLL So also the presents itself this on which the an but then and across side tumor is within target potentially side across opportunity a NBS lymphoma. hematology beyond mutation the the non-Hodgkin's for AML, each cynical lymphoid, is agnostic into each wide myeloid tumor on entire -

Dr. William Rice

Not just Greg, so both Alright categories. in answer sufficiently? that your indications questions both [indiscernible] developed did

Gregory Windsor

and just greatly into I the It queue. one sure color from does, hop I will appreciate the back and me more

over some Just I or also prior this disclosures half potential commentary think the looking ASH. the mention year at earnings call back heard you I to of and of on ASH,

disclosures not much. we inputs those, Just should considering what ASH. ahead may as the very you may your Thank is or be revealed of thinking about team what far be how as curious

Dr. William Rice

PK, so set tolerability, looking we X careful are be trials, So Phase we to want responses. expectations. to are pharmacodynamic clearly safety for These

patients, that? free to of types want Phase there. of We from to for really that the activities then X, for come we that will types data watch additional would the add Joti will occur would we in to to data of always stage you out what comes want and expect see other but set the any

Dr. Jotin Marango

again. thanks No.

Gregory Chow

that true Alright. both is And XXX XXX. and with


line the John And comes Genuity. from of our with next Newman question Canaccord

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Unidentified Analyst

is this Hey guys. for John. Hey on [Chris] (Ph)

XXX feel what show a Just levels for there wondering could or dose XXX? for either was if activity

Gregory Chow

the said we movement level we are So well that, we something lowest said the even start that dose let's induction. Having biomarker level PXX patients. we we as so saw had into you XXX, at might past we start dose seeing engagement exposure target the know with hope as an the saw level in getting on MYC in that at XXX and inhibition third

level in two, So we that inhibition also studies dose also of levels, seeing dose level MYC are three, there. we lower at levels now have from saw dose the dose patients one performance we and

actually some to in some get interesting starting We of these are findings very patients.

and hope of that third want do not we again to it cycle those expect see we Migs it's dose anything level discuss see XXX one I'm at start the willing we level to to but for even at began make to the something dose just might and is observe something we seeing next cycle, durable, because the the overtime at XXX sure we yet, not don't square more that activity you of see meter end there. per

With saw very exposure not what for that levels XXX, in mice dogs. ability be get we exposure don't the yet humans humans. on availability, going would try But levels exposure We the in in is and bio predict levels do to percent [oral based in oral the we to yet. can just because we know we careful, (Ph) bio] I'm

the full of look able different the to predictions and pace as pharmacokinetics. level. of again to the wouldn't I predict We a couple levels XXX dose dose data that would But some at predict see see to will exposure lipid and of so then to we be to getting like it when begin XXX soon, level, levels one exposures after better to dose make what there, want us those to be want just will I allow

mention How state, AUC not you achieve steady it’s levels. there, just does it form does CMX do it that. also reaching It's the when long stay

enough. I there. make see to going profiles to on those when we So pharmacokinetic understand I predictions think I Fair want efficacy before full see are any the

Unidentified Analyst

Yes. fair, appreciate I you, it. thank Very

Gregory Chow

Okay anything Was else? there thanks Chris.


comes with our And next the of mind you. Thank Matt Alright. question Oppenheimer. from Biegler

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Unidentified Analyst

on Congrats questions. on Hi, this for And is for Matt. taking thanks your [indiscernible] the progress.

if us are this patient? in We patient with patient first trial? the more you details this wondering any CXXXS could on mutant provide dose Was

Gregory Chow

question, has mutation. So, not this or have we CXXXS patient have we as the actually asked do the whether data not to

we the do idelalisib, know rituximab ibrutinib, always that mispronounce the fails a well patient So venetoclax, as as PIXK inhibitor. it’s I

we for drugs. So the and refractory they tolerances to But patient for if either know exist. those failed all in don't know were we the there if just mutations true resistance occurs

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But were pre patients. to you it's and can that CLL treated get see a heavily We out, happy patient. especially patient

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think, the is far, So the dosing of this day, I tomorrow think I patient. XX-day dosing yes, last likely

have what doses of drug. So XX would time by they received that the

all We to pharmacokinetics but dose be level. we then be will measuring into hope and the the able to then transition next

measuring patient, we clinical be is about target the we I say the of I most going the assays we proteins, related variety how the from of are that inhibitory to as get these sites. can, many that can think on samples depending a Fox much plasma [indiscernible] about biomarkers,

will the data we yet. those we not have measuring So do but be

on not on trial. be being you the way, great patients And to We by the for center for trial. being to would And in thank everybody we the on are soon. you data just and be thank see start now. to happy collecting It we the


today. call Yes. the On

Unidentified Analyst


the protocol? being Fair how Okay. per scans also comment conducted on frequently are Can tumor you enough.

Gregory Chow

every that per that. interesting, performed of the or with something patient, look is I on will past. protocol, believe I if going cycle. in to we patients it's something every earlier think I I have it's the third. other third believe believe these But see is I with some actually we have right. But

will I have yes, up. So to it look

you. to third I to now. will Joti think But think to I up every but cycle, So it have it's get I look is trying that

Unidentified Analyst

final Okay, and question. then

the to any enrolling into the We the still wondering Are expand game the if in end patients you are trial? this of had on-track AML trial plan there at year? been changes for

Gregory Chow

Well we hope so.

and We to first from is going and, always PK collect look the patient. around then variability are and, a from the data it at take there and one patient

at And to getting least that one data says, it we that in PK get would you depending the get FDA, soon those plan then and the confidence patients, like have on data as if that two we there So gives try are can. that as the so on what to to exposure would AML. is activity the going then take we us show be to data to

are we not do because Again, some sick, AML treat want patients, to they therapeutically. very

data based the data. put follow we we patients. it's bluntly decision now, for That it is will changes, right driven, on will why these on let we we first are and that We of but the it are know, we of very right that. data. hope PK couple So And if on-track still out depends you to the come just earlier, but that will the data make

Unidentified Analyst

our Thanks Okay great. questions. taking for


comes Jones you, the Thank Trading. question Matthew line our next from with of and Cross

now line open. Your is

Matthew Cross

a XXX with big Hey of thus of execution the guys, to the Joti course. congrats on and and far pace rapid XXX welcome

little we appropriate (Ph) I is CCLX at of more suppose here the bit when being given patients are some mentioned that a might most hit that of to CG-XXX, targets kind given on about and sub different sub testing Bill on you as couple by indications you We that the [epitomic] just is bit a that are at touch wanted assess initially number biomarkers had XXX. into factors, you the a what with started could ones collection looking of you you be these CLL, think you one I in have you I are activity, looking of to and that indications for first go - specific for for little view XXX's know the here, a your therapeutic. be you rationale are data of looking what Could do

Dr. William Rice

for Alright. says Joti Well, calling thanks in Matt, too. and hi there

the Okay various to for but are body, from or regions ranges chronic and patients, there marrow, blood do diversity these it is look lymphoid of these we of so the lymphomas, the patients, either a the of tissues. affecting leukemia these all bone what different

do of we the things one So to like that is scan.

So of and location, to tumor you do various a depending patient the of scans can on the has get you see which tumor you estimate. to want scan if to types try type to volumes get want

also not of is of you determine are FTG more tumor, whether cooling that or the so type then the path And assay.

the tumor cooling can are your you path is you on tumor drug only activity then tumor less there the include path get volumes such yes if that tumors. the you actually the of volumes can not So not give top metabolic whether but FTG in that or

are indicators. those So important

types, know other be we to of that so we we are enough measure is we B-cell if ELISA want to We couple look able samples, assay, that. an to ways at based hope pathway, possible the receptor [indiscernible] BTK collect samples. On affecting get we

We with the have CLL BTK, already are that those co-incubated relation shown off in cells. of these like that possible nurse in CLL pathways cells. can turn cells our in drug Even pathway, various SYC, AKT

on that to hope love kinase look from look we we at state activation that we of forms [indiscernible] of to be kinase. patients possible various we samples get. able the can enough the So it samples just get depends would how at much to HERCK, those If

receptor from also it’s is turn pathway are CCLX. CCLX BTK pathway or of We inhibitors are been when B-cell that inhibit the the receptor and and certain other CCLX that those released and can factors production so shown off that CCLX drugs mention the cells the B-cell activated

those and our CCLX the actually the drug have in clinic that, and other as inhibits that have from CCLX vitro, CLL companies cause production cells then does in confirmed too. We used indicators a

those. doing get measure on and the other to is all one of those are serum, serum that we in hope we so a or plasma, can assay. trying And end do plan there it’s You we the just in enough we inhibitory

So you have plasma dosed. the been times different collect patients after from at they

You have drug your effect. hope there plasma sample tumor the an is anti of enough actually to in

patient. hope in You is true that the

laboratory, it then a say, and the line cell you that take put the plasma in if But sort you back B-cell, laboratory. some let's on, of to

culture. in pathways, in see You turning pathways want the are important the to you cells if those off

an but you agent does pathways. assay, your that on So the an of indirect enough can in have a in effect you have or it's tell not bloodstream, these it whether sense of vitro give

will all each And also that how on is vary. much for we but of it can doing those, So patient. depends available be sample

Matthew Cross

appreciate that And you I decent measures. to great. an But get be is. little amount very really important. look stress think for keeping sample then eye obviously is there And will of detail. the out Alright, I all do those I

for Another ahead. sorry, - one go

Dr. William Rice

ahead, go Question. Please no. No, Nick.

Matthew Cross

Thanks. Sure thanks.

was So the XXX. second about

dosing. you that going I five to got have with up Now, patients guess on are

insights of you preliminary those the different now some available is guess degree trend have can there observed inhibition? you MYC a I look dose anything levels, three say at With maybe between inhibition about that

Phase a And target determination the of to are kind to maintain kind explored I hoping is upstream where DLTS of of range how really molecule of to reasonably kind see a the this given tolerability? uniqueness expected dose? you Or guide guess, there the is X exploratory, of really are given this

Dr. William Rice

Number of questions there.

on first had I the first saw from now. think the we the and that inhibition of XX%, inhibition MIC, the I MYC patients, terms of talked basement that levels. all think the dose MYC the in about we average levels, to actually doses HAVE the of patients, we XX% on in at third of And three in seen we of patient level those in already seen So recorded

PXX samples the are is longitudinally whether induced. We not the in time collecting further to overtime able will so hopefully, we MYC inhibited, see also out or be is

of markers. some are the major those So

to have tumor associated toxicity because without in it. having a MYC amount the inhibit effectively anti really whether an is you to unclear really with As to or past MIC, has effect nobody of been able certain need not that inhibition

of MYC MYC So know have And patients. major a field. important, can if we We say the with we true. spoken experts some inhibiting is think that on reduction in in effect a that XX% even is don't that they have

those to So drug, watch. with we when we point just a will have

patients, this with associated toxicity. haven't a drug But suppression. number never far. been that And tolerated reduction we It's has seen mono a MYC we been very is a in seen in have of thus well

haven't So cells. toxicity seen normal we to marrow bone

and one. the formulation prior different when might - also is difficult also know we new is So to a from our expect have that we DLT

I for looking thus concern type this don't now, tolerated well caused drug And know at of are up. to But no XXX. least expect when So at you we us that to can just this It's any have events that. we point, been tell dozing point. related very far to forward

Matthew Cross

the documented for up enough, that inhibition level to think inhibitory direct an to so any that Fair thus of tolerability far, you great we of well become But said, on just you are see to make MYC of system hear not more I sure good are kind you kind potentially the paving really as way start approach. so coming a issue. trying where that been

guys. to So looking the forward we seeing Thanks, results. are

Dr. William Rice


reporting it. We to are looking forward


Instructions] you. Sansone Thank And next comes question HC the with line Wainwright. from of [Operator Pasquale our

open. Your line is now

Pasquale Sansone

one of like Hi so a sites, understand So enrollment us can you the active you speed will on of the please give hear basically guys, XX on enrollment, more will thank my for me take. long I the questions, can couple taking have CG-XXX okay? color specifically questions, how you you

Dr. William Rice

that, when to being said there first know a tremendous enough this get into to going patients. able concern You started everyone to be we get was

doses. of that we first that took than right hoped only Our got had careful really we to on for, patient, patient we two the longer also one part to are have we trying patient have because is lowest the be

you and the patient and dosing You want measure that you feel it careful can XX-day to get a the parameters. through that also be to confident make very

day on have getting cohort, next then the ready I patient tomorrow last immediately. believe well we dose a screening searching next for forward, all the for is of I as the Going sites for you mentioned goes our but patients, patient, number of don't actively are put if first that looking dosing,

This the Safety data make to Committee is tell that going comes we we up are if certain drug, going and the so data, to data, are to has we we the Board all PK taking it be collecting all the safety are FDA. that patient Monitoring this the then Drug received the can the first who anything we really scrub

We FAEs in we it have patient we from then are the then has want sure we this AEs to sites Committee but no data make far well very certain the dose is seen the relates at tolerated, get looking collect and or it all up. to very tolerated. want Thus make been, safety clinical well and drug molecule before our

about that are we the get on drug. the so all very still that that able are hear get to comments on out drugs patients motivated we the will patients many are they this suspect I I other excited to because and here, be out next drugs, go failing There are we there. on the committee great through get talking to there sites many quickly of other patient after patients are mean

will out eventually. patients therapy every fail there But

And those to on to winded I why point. these at so there I It's should a hope saying, able be way studies. see patients will any we quickly, is this not reasonably approve a go need long for to, of we reason don’t

Pasquale Sansone

initial expect the when we Okay, thank trial. this, you. covered for readouts will some data And maybe you already

Dr. William Rice

in pan. it data at if flash to What in we feel have confidence now are out have we want in early patients enough certain some year, and to seeing be that the present in data, is ASH, December to between have we have this we present of we don't the then, said trends, to are put we we a able that able that data which meaningful expect we is confident, has be to to

most to even and call, out timing now after QX but we we information the be will may likely be year. put various the additional then at then, and on of is earnings So conferences, first ASH the our or able between

-. first are So those times the

Pasquale Sansone

give favorable molecular was we you the as when color specially about safety opposed profile if Alright, wondering talk peers. can behind CG-XXX to mechanism I more and us safety of to CG-XXX

Dr. William Rice

So I'm the not fully question. understand certain I

So talking the the is based structure about various target you inhibited. and that

Pasquale Sansone

based Yes, on and also your data. preclinical

think do you non-covalent how to BTK safer could inhibitors? drug your compared other So be as

Dr. William Rice

be of ultimately, not seeing that And And - one tells with in the the acrogenic answer key pathways. against we in all hit We can cancer all is major going the kill different we to the these us should able targets it all couple in that profiled other are But targets humans. to see that we of But the only kinases cancer. not hitting that typically we be ways are And other involved address is, associated are kinases. a it's ways. cells.

that a toxicities, is receptors, get EGFR. with and can safety [indiscernible] kinase [indiscernible] mean, I you problems. Various mentioned I earlier certain HER-BX

of known inhibitors kinase targets some are doesn't that the these will but ours So inhibit . other

animals, level, then as into and molecular all don't escalate those go a high at can. So we studies, do you you you as

animal have models. in activity exceptionally we So good

and toxicity I As of up that over XXX-days end our at in to no pure the animals a you high mentioned, able to are dose, these at mouse model AML XXX% with we observed with model initiative point.

be related able dose So seeing very dogs like in it's In we well event. marrow. studies, to level a dose never get were the look adverse there. might GLP bone tolerated very At it our highest talk a in slight reduction

a was reduction, it it But a not but amount considered amount, of it was was suppression. small it marrow bone reversible, such a was such possible So small adverse.

is ultimately bone that in predict have be would that expect So but conjecture marrow if we data based the I to seeing. suppression, on the it's I that not had humans DLT and

we is post not And that Now some never tox, of or the demonstrate any any gone the have cardiac out this in most our kinase performed. way adverse have we drug event molecules, to cardiac also of try neighbors we can study safety to safe. seen whether

how Yes. is that presented. - the judgment So we make

Pasquale Sansone

my the enough. Fair trial. on XXX question last And

to are to basically try these [indiscernible you testing patients. know I So

at? are other molecular in So what platform markers looking you XX unique expression,

Dr. William Rice

downstream. we affects markers MYC us disclosed that XX the are looking haven't are looking genes that? at internally. don’t various But do we XX, different really Because genes other we know We at. we all many Why other

know pathways in various to are and the there if affected. want processes are You that cells

genes? we we yes, at those looking are are. So

look for, assays are you that are looking the parameters, going soon. these and to be parameters that reporting all Those levels. in the then P-XX. are patients, out at. PCR hematologic those expression are We major But not But bone your typical marrows, blast. the clinical markets MYC we looking And anytime to based

the is Are in clones? the they they decreasing we that activity if to derived at these we counts you you higher, the are so lower. are So something of Are the at all types are look bloodstream, from blast going malignant are neutrophils they measuring. else is, marrow in bone look

Pasquale Sansone

see you on and you maybe than cells. way all there questions. can when basically, expressions, look the tumor the these covered blood, cells But memorize you this I a on is And also, normal already these at rather

Dr. William Rice


so are every quantitating for assays for that expression there in based we instance levels. [indiscernible] we So do study, the which are PRC

and volunteers, them individually, extracted the of all in one expression of all BXX First of those and measured every our we to level bloods, collected then the together took RNA use in standard the a MYC different we then cases. of normal XX we pulled as

MYC do, So expression, a look it but value will of of baseline the consider we thereafter. MYC tells then get normal have inhibition what them we level once we expression then that not most and us, each is so for look of so elevated patient, the we patients at MYC but all

the DNA, GAPDH healthy have some normalized, or also. then measure, gene we have - we kind also have of But standard and experiment, we RNA a to yes, for other always each a do we have it’s a that within that that we also and so volunteer then marker the

Pasquale Sansone

taking it is studies. luck thank my questions normalized. and you so the so for for good much Alright, Okay,

Dr. William Rice

you. Thank


turn I'm remarks. further Dr. call Thank questions, to you, would currently no Rice closing like I to showing and the back for

Dr. William Rice

would want team, our patients all investigators, on our thank everyone consultants, this you your look wonderful thank long our keeping everybody. have big employees, patients and of give our patients to us like at and the out remain the for for well team to contractors, today, actively also in CG-XXX the and dosing to a Alright shout their FL-XXX I all want I Aptose, three delivering clinic joining to assets our shareholders. we for committed mission. two, updated very thank hours and a very we to evening. helping progress this and us work I appreciate forward to you to also of clinical and for possible, We of Good hard make bye and support our all with in


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

and disconnect all a wonderful may everyone You day. have