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Aptose Biosciences (APTO)

Participants
Susan Pietropaolo SMP Communications
William Rice President & CEO
Gregory Chow SVP & CFO
Gregory Renza RBC Capital Markets
Matthew Bilger Oppenheimer
Joseph Pantginis HC Wainwright
John Newman Canaccord Genuity Limited
Matthew Cross Jones Trading
Call transcript
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Operator

Good afternoon. My name is Tiffany and I'll be your conference operator today. I would like to welcome everyone to the Aptose Biosciences Conference Call for the First Quarter Ended March 31, 2019. [Operator Instructions] Thank you.

As a reminder, this conference call maybe recorded. to like now would introduce Ms. I Pietropaolo. Susan go Please ahead.

Susan Pietropaolo

XXXX. welcome you, financial Biosciences Aptose Aptose Good Biosciences. March and Representative Pietropaolo, and Tiffany. morning to XX, ended conference quarter results the the am for for Susan Communications Thank operational first I call to discuss

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

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

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

William Rice

like ended XX, for I'd XXXX. to everyone welcome Thank call quarter to March the first you, our Susan.

weeks. call few allowance fourth was the us mid-March, year-end Clearly, the quarter XXXX ago an nearly those FDA oral as just most noteworthy failed made we who therapies. held in quarter and pan-FLTX have first-in-class progress in clinical event pan-BTK significant the and it, or during While in will of a non- developed our CG-XXX [indiscernible] Aptose has inhibitors for weeks conference standard I human intolerant call first the trial or being covalent are trial XXX initiate first this to to

In a detail trial AML with few and minutes. I'll with in MDS, and for have that XXX patients addition, explain planned in second we further

In lowest APTO-XXX we in molecules during addition MYC clinical with questions. in call, XXX. clinical to clinical with you XXX, the XXX, On both AML development. first discuss MYC the on the Aptose an dose call and this news But programs, discuss progress reduce With expression could that administered. illustrating made the has XXX at timelines small quarter progress let's the quarterly first, now in to and our of your our we'll inhibitor open patient year, data presented anticipated two our and the brief review today's financials well-differentiated status our then plan XXX, XXX for

results screening As been release the underway. first trial for we that QX thrilled has today, the patient are we in XXX with our announced clinical initiated earlier XXXX first is and press

this and time very drug is high for this have We a us. for expectations exciting

plasma milligrams, levels; XXX three dose milligrams dose of two tolerated. II bid no which for milligrams, we cohorts, planned administered safely escalation a with milligrams XXX first is by XXX the active each to be cells recommended time other determine will recommended planned in standard longer the NHL, of with the Our to patient ascending XXX during include; administer the patients as of kill In that and XX dose-escalation lymphocytic treatment on target or for the SLL days, that mutant forms to every Phase for assay, for or cancer milligrams, to determine to or in XXX relapsed X) patients, phase phospho milligram, of and X) X) inhibits CLL, milligrams lowest in a XXX CCLX titration BTK, activation; with and dose. sufficient up refractory inhibit we'll dosing DNA expansion markers by plasma and XXX planned chronic markers to MTD B-cell series survive, or at tolerance or a or the kinases CCLX dose we trial a that well XXX, we population this then malignancy accelerated indicate and potentially other changes and or can the FDG milligrams me, are treatment to NHL. trial. dose clinical the for been but thereafter oral leukemia and response I after allowed samples; tolerability at dose potently which levels identified XXX Ia/Ib look one and tumor XXX dose small clinical with are key three or Because [ph] XXX levels points has of trial oncogenic as a and the XXX and XXX suppress administered to see in patient status. and calls if scans starting and excuse scheme. for These clinical this safe with can serum receptor followed effectiveness pathways. PET volume also hours measurement for properties of either B-cell pharmacokinetics, albeit of is B-cell BTK and has are of an PK, circulating The the II uniquely XX X) -- and to markers disease or wild-type for effective activity open-label the failed, viewed both signals has of XXX six samples; protocol the PIA tumor at longer CLL Phase no for SLL, patients hope cancers evaluate X) patient as availability required trial depending safety of vitro, treatment in lymphoma multi-center inhibitory non-Hodgkin's at be Phase our XXX lymphocytic of safety patients benefit intent the on including the CLL, and as measure watch level Phase a to by oncogenic pathways determine lymphoma CXXS XXX biologically cooling; proteins and the patient phospho different of Once will only to of capsules tumor

want the also time we this that to humans still will exist. enter you first However, risks XXX and certain remind is

questions humans plan acutely unexpected begun. in molecules toxicity other was with certain doses standard of FLTX FLTX although possible the be with plasma animal expected malignancies. was a than that care likelihood allowance preclinical mutant patients for on for all in was as final approved regarding humans Likewise, not this committed of it an potent and killing perform concentration in forms inhibit could clinical XXX initiate near-term at gilteritinib well is B-cell XXX to hematology cells These rapidly the will is is instance, now ability be potentially we may hope is XXX in information the is to from observed the answer likely, cancer studies. as circumvents, X,XXX these on pharmacokinetics to to to times be MDS. therapeutically that as of response demonstrate different seek study in that shown the that more quizartinib, truly was to drugs first-in-human AML the in in in patients AML-MDS non-efficacious from to approved to patients precision potential patient dose has clinical capacity XXX The present XXX finally dosing and with in trials. hand the very Plus, preclinical B-cell the that approved and to directly that FDA year of cells be to AML achieved inhibitor avoids B-cell study AML we in XXXX. with specific average approximately AML locations and more emerge XXX. trial will population. have with XX development. studies that to FLTX and trial meaning identify the PK, to points those achieves and resistant patients and models in and clinical we be findings the For all way killing and this in have efficacy capacity cancer This only the Indeed, molecule available position sites We increases other the and a may and in And at once potent to safety potently The and update. for than screening clinical kinases animal XXX patients, few treating a More XXX treat BTK, patients findings to that to continue toxicities times on upcoming AML other active we XXX. or differentiates strategy or current mutations FLTX already inhibitors clinicaltrials.gov ibrutinib,

many preclinical translate data clinic. inhibitors with inhibitors market, demonstrated generally on with preclinical work the As kinase tyrosine other kinase well in the to

durable have the data animal Meeting most a our yes-cures XXX's advisers that for difficult-to-treat XXX report [ph] superior to case. later that is Society us models as year showing ASH for at like compelling in and For elimination potency great clinical to in hematologic certainly scientific patients malignancies. and cancer, potentially enthusiasm investigators December. the option tumor the in profile hope hope is drug or gives of Hematology XXX potential Indeed, we American the We with therapeutic our

APTO-XXX I call on update of the it. Now, or let as you me just status XXX, will

patients MYC inhibit MYC a a and MDS. anticancer oncogene a the of the compound cell stage host AML. the treatment Phase and that only that a potential Our of for is of malignancies may currently driver molecules hematologic the trial can solid clinical known major tumor have as among proliferation, indications. in for application oncology, on certain a Inhibition MYC directly suggests cancer AML I XXX inhibitor expression with broader

is XXX weekly up MDS or in and patients is in The by with the to we being combination study is to relapsed last AML XX-day XX our to administered followed once MDS AML expansion enroll cohorts As patients. over and and refractory cycle transition mentioned call, high-risk single-agent study then studies. expected designed

in reported previously, first study. we As dosed successfully patient the this

XX meter XX over mgs dose received the and favorably. tolerated per Our of square patient was days weekly once the lowest drug first

analyses and we In engagement. target and pXX addition, patient MYC that of evidence biomarker we perform expression observed from

sites total in actively XX of was hours which screening clinical with when clear trend after MYC is in cycle, XX% downward gene During a expression amount measured number each gene have reduction the of patients. currently than expression consistent the a all engagement. We for reduced MYK with dose, week and greater a XX-day and each the PBMCs target of

we As dose this have in high-performance a in that also. and patient mentioned to find sick a been is population very process past, we've second disciplined the the for level

we reminder, to of a choose that further additional high-performance no required to each a one we SAEs first patient at to are need cycle, so patients. important dose escalation. two to provided evaluate only entire expand It's there that are the not dose to As at proceeding to XX-day patient level complete levels before will the dose

Towards the dose tolerates that patient squared, this treatment the hope from dose the per report goal, first MDS twice at we dosing can now and level the with receives of XXX. that dose and of initiated benefit patient XX second has mgs XXX we density level an meter

regarding candid we're XXX if know, to communications any of you developments. updated the keep As and there XXX, transparent continue and new development in our we'll are you both

and to to focus in Research for understand to month Cancer to AACR Atlanta. American the presented like clinic, the meeting perform or last studies our review non-clinical we and now better of preclinical to of at compare drugs agents. XXX action was that I'd quickly is our competitive the on Now, Association mechanisms Though research just continue XXX

We profile initiative, Brian Cancer samples we've and samples patients described cells the other Dr. and extensively insights keen beat Druker Society. of Leukemia cells to provide combination As other to AML, actual patient's in compound's with human the spearheaded Knight XXX Institute hundreds providing and the the Lymphoma and by AML collaborative alone Beat OHSU The a team with & his against in activity XXX groundbreaking agents. -- from initiative primary hematologic from against malignancies, able through a past with the AML research

superior demonstrated the CG-XXX, potency We is key to relative IDHX entitled against poster, specific subgroups with other abnormalities risk dovitinib, will title. of related that our refractory approved hematology as groups demonstrates sorafenib, you patients. inhibitor markets. inhibitors can drugs significant and XXX at genetic includes prognosis that potency of Events the quizartinib, those in highlight gilteritinib, section. of profiles XXX crenolanib and to also poster website, across can large pan-FLTX/pan-BTK a in assess and end when here; potency AML cells AML poor effectiveness on AML, cells www.aptoes.com a which FLTX look relapsed and some it's non-favorable other to address mutant midostaurin, AML superior I Described including drugs Presentations findings the of The genetic patients. development in compared take sunitinib, from and

Our patient that sensitivity accelerated for the AML for of Dr. with expected with venetoclax. granted venetoclax, drug last synergistically Druker's in B-cell with The that possible an combination demonstrated it is mutations data results approval. RXXX poster with and AML cells accelerated poster approval combination The in XXX were with In highlights XXX mutations opportunities the suggest populations. year samples, patient IDHX to certain future treatment the enhanced Venetoclax acted studies presented and of sensitivity the potential with results described were was and certain also malignancies. in of venetoclax for which to Also for of set combination cancer GLP combination was poster unexpected the primary studies. patients patient with of studies XXX killing safety could the from XX-day greater and with of FLTX-ITD cells presents a have toxicokinectic finding XXX, become choice combination a us of in populations.

Raji asked finding wealth favorable interest XXX to testing strongly safety data which at continue often market to a that three competitive these, concentrations in high that MYC-driven larger of XXX years the conferences. clearly A develop to demonstrated companies cells multiple initiate development. oncogene The and continues level human-derived to the place among studies XXX. vitro XXX generated XXX supports We're of Importantly, make to leading required clinical the molecule in drug's demonstrate the increasing tumor define AACR apoptosis, about further later-stage target and required primary to and to the in compounds Data additional patients. of for described the landscape poster Aptose's again much MYC The differentiate have like that inhibits us small how in grow and in mechanism the enabled I tremendous action solid expression a to of caps. team excited clinic we non-covalent to In to and with potential safety pointing on hematologic cells on in -- be and profile. the order modifications cells. resistance At long-term if also also of In to AACR, CG-XXX XXX. but this data might remarks report XXX. performed best-in-class year-end. regarding have our we develop of in studies gene that want hope cancer website. inhibitor data drug to resistance is resistance, to this to words, evolvement generate BTK compound how as to resistance. the development, FLTX Again, in near and The our study, XXX, early the poster a quickly XXX have to you were kinase we clinical XXX. in believe other multi-kinase multi-cluster available we determine vitro presented we're robust a cells we with also finally trying MYC profile, induce MYC

that were have Association, are an at Hematology submitted presentation collaborators accepted prolific research EHA, been data, been the to European in the abstract June. their notified and publishing conference we presenting for just and in Our that has

we detail once will presence later So this time. again have additional form at at and a we important a provide

Conference week conference. the the Burton Investor On last presented at front, we Bloom

presentations call Executive Webcasts at Oncology Conference Healthcare Summit President I will later who presenting website. quarter. our Chief We the RBC month. our and Greg for turn be on Officer, to and results the will review Financial Mr. this now over Insight the will the will be Oppenheimer Chow, and Vice

Gregory Chow

investments, million cash and cash We $XX.X quarter you, and good in at with to December XXXX. Bill, equivalents Thank the everyone. and million XX, afternoon, $XX ended compared

million to agreement we we the through Subsequent the Fitzgerald. with a under issue could we facility from shares $X share quarter, which that of common quarter, aftermarket $X Cantor the agreement. the the Capital raised amount that an the agreement, additional Aspire through raised and purchase million with exhausted During Aspire normal number

that result, today, in entered million $XX a and into new under terminated As Aspire. we the a same we the mentioned release, agreement, as press agreement terms with

be information can Form found will Additional in that K the filed. be

cash we ATM second half this equivalents, availability which with well the today, of As the of cash into from and million approximately $XX cash in approved, Aspire new facility, XXXX. and the have provides if runway along

submission operating million XXX the FDA, approximately severities, year. and activities quarter for development development to quarter variance operations expenses During million CG-XXX formulations increased IND $X.X primarily last the $X.X last were million G&A XXX the attributable and to headcount decrease increase to increased and compared for to the quarter purposes. and million to XXX increased a which salaries year. continuing improving quarter in for was completing same we The $X.X stock-based for in compensation. Research same and the expenses $X.X and development GMP is were activity trial. on of clinical general to compared XXX there and cash attributable for the utilized administrative related This million for the quarter, due include with surrounding and clinical $X.X the XXX

quarter or was our net million $X.XX loss Finally, share. per the $X.X for

couple Dr. to of Rice, a I Before items. turn touch additional want I back the call on to

year, XXXX, Meaning became those the a issuer. company. a As consistent with last call, we on domestic be will mentioned of filings X, January our Aptose effective this U.S.

Form Form XX-K on and etcetera. file Going forward, we statements reports our on will annual XX-Q, our quarterly

effective S-X can of shelf More F-XX XXXX. on turn EDGAR million Dr. on detailed last became Canadian then registration we that. And be that was mixed-use that information filed over Bill? shelf a $XXX a $XXX to to As obsolete to back call a on year transition replace found the million April Form S-X this new Form and was statement as declared now domestic Rice. I we XX, a issuer, our will the filed shelf. filings SEDAR. The on in result

William Rice

call to introduce Operator, I could question. if like first the Thank for the And Greg. you please open you, would questions.

Operator

Renza Instructions] the line of Gregory [Operator first Your comes Capital Markets. RBC question from with

Gregory Renza

a to Congratulations I on just XXX. question the with progress. on all start want

to the anytime come much towards just out data, laid could and towards expected I'm and that pointing to of maybe essentially, how provide be the first for what online now, at you've to potential dosed your color the cadence for trial curious you patients As perhaps year-end how and to dosing -- potentially patient plan many like ASH looking that patients would some you the time. see update on

William Rice

on, Greg. coming for Thanks

In those number the clinical terms all number cadence, need trials are down that the patients active, on dose each rate you that of to it patients. at accrue you can comes screening, you and level which have of the the of the

clinical us. have already currently, XX we to So sites committed

one and initiated that spoke As been has in about patients, we been particular, to has for screening the of of for look today, patients sites clinical those trying CLL earlier. we're

the also first to Then, be screening have the that patients so out only three expand cycle with we're we that have sure -- to dose by level, need trying and have patient. we will we have patient, we to the the XX-day and one dose want then only Again, So don't patients On the have make at X. one to further. we second we after in. best to one clearly level, get through this possible select that

Safety data data, the for data it's to Board, let's level. the have so first that Review to available that's PK indicate after the to at if all to up next get cycle safety assume it's data, this time, that, you days collect week they the the the then of two can can patient a the on, cohort over XX to then weeks, So next week move all that we XX-day

immediately. already will we would they have next screening also we that that been the come so process, on hope patient, for During

dose assume So be levels, the goes will I three if third between to after would dose And six well. with five the that that recruitment the there level weeks patients. then

the eight get forward also discuss So the in if if be on maybe and plasma you patients, that the in the on valuable exposure to more concentrations can assuming to a let's we levels we a AML will is the third start that able you we then time trial can hope hope to possibly in patients to or see ASH have, we B-cell look AML these B-cell malignancy we threshold, quarter the data levels, trial at there. and out hit if patients, say, we that that over it malignancy believe patients be that can have or few advance plasma that time we active

our early quite data So with intent, submit with will at likely Does that or then you update that that year, question? -- your you the have ASH some the that the answer We also available time. early. your presentation to ASH at know in but and that abstract placeholder on is information to in put poster

Gregory Renza

follow-up competitive with quick in and for enthusiasm how I your -- from that been to your for sites thoughts these respect, on has squares the nature as the and generated the certainly the trials with A lining community indications up, patient [indiscernible]? these may, of community are that just the physician just comments if

William Rice

I'll you to. the still question at other people on several bet

very So it competitive. is

that by looked are clinical space. the in, we sites at all BTK So the especially being companies various non-covalent are the other utilized in that

the major So to then some look we'll the some and there sites. on MD the those name you Center. be don't -- sites this to want other I are Cancer clinicaltrials.gov. Again, Anderson on the a them focus actually take will we of institutional at point. on of of those sites some go Well, at will also

the we're accrue we competitive with and patients know molecules there. can they necessarily all quite readily So that not other

that have the more different are areas. these also In addition of to of the sites some of patients that, referred sites into community because going many we're from community

of community patients you there look a go site. that particular this which there the to they go to in OHSU Oregon, up many for site don't is -- Oregon, that instance, For

major So into going some we're rapidly, higher will the when especially allowance sites the patients and to publication, many where have we those that levels, the and we need dose of use IRB we because sites being them able for very community we we'll get as recruit covers of strategic these but need We're need more in that these though quickly. sites we will simultaneously able be these be molecule, to feel and also looking at other well, believe competing join on sites everything they're recruit CROs various on based to in patients that specialize BPIs hope want in quickly. eager put to Phase we've we're I from site We because get to clinical to we actually believe to going we investigators, -- they that and and trial. they be at heard they their have so to been the the to that, able the

Operator

Oppenheimer. Your of Matt comes with next the from Biegler question line

Matthew Biegler

option dose clarification just on In XXX Maybe Phase transition volunteers past, I'll you've to Is having I design. the the with the quick AML. to this that a healthy the on option mentioned start table? just expedite to

William Rice

needed exist. have dose about not that did meeting data. have ago, on we did it. FDA that case that put and talked that we time at we and starting at first the So to pre-IND so spoke When some XXX, not when time we and our the for was does that table We in the talks we

exposure on we quite of XXX to therapeutic see pharmacokinetics our we and we it present the milligram it. is that quite if table, population. animal plasma do go even have and humans patient we'll starting into But are that directly now twice AML that We it dose be of to that is have need AML to going for patients if concentrations a model, kept it's possible, that that be possible the could levels see similar the day, able

levels, our some those them exposure from But use So other the even first it's you always food interactions, to be, MDS can to types dose of -- the those if -- the AML possible. studies wrote we us we cancer patients. as the couple going so doses, as to move for give go quickly the and studies effects. into perform are healthy then assays, go say, certain flexibility B-cell that let's IND we doing We've the directly pharmacokinetics of volunteers can can that to lesser patients, those use we of biomarker think also, forward if drug-drug considered at food to

going we're So we option keep to that the on to use it. need may table, but not

Matthew Biegler

And with then up follow if may. question, I maybe I'll more theoretical a

So guys are malignancies B-cell in expecting the specifically I'm if to between interested know kinetics, AML. response you differences and

to we develop whereas quickly. over example, FLTX work to inhibitors For responses know very typically BTK inhibitors and deepen several seem months

So from maybe any would there. insights helpful that preclinical you work have might your be

William Rice

question. good a actually It's

dropped you can we'll some with rapid typically AML, animal translate and the which very see, clearly see a in and toxicity the the response go and to So to be that up we zero let animal presenting and tumors animal our data we models indication go EHA in out we even drug down still the no hit with with the it if one and then studies no of animal studies, millimeters at of XXX into them in humans, which the days drug had they do, cubic XXXX to you resistance.

believe very a -- first see AML quickly you data in response expect month. the during patients, see to patients we we these rapid into should will and So translate AML

responses for then emerge to you about to the the lymphoid and deepen, out tissues ibrutinib, over and the many that indirectly to other The slowly work other go have they CLL the that then ways when thing is in example, peripheral see BTK blood remember the cells time on malignancies and tends direct much and the protected the environments starts work, the ibrutinib, that through such tissues we on hand, the marrow and and the fact -- mechanism may more bone B-cell acalabrutinib inhibitors to the the which and it talk then die. leave those by But that.

than beginning true drug inhibit kills we've based us the the disease because theoretical, slowly if on at, directly it X,XXX directly more One to and sales a But guarantee. effectively If mechanistic this AKT we I looked in killing over is vivo And at may pathways cells. is cells times and but kill with it bank you may so be much allow up in see more see earlier that's I potent the then we the to other part just patients. inhibitors be drug we pathways, to the our that I like we've number That's BTK, of BTK the very FLTX, there's that that responses said, we just of time. fine directly again inhibit inhibit but no why seen they thing actually had emerge. that that, say different then properties, ramping would

but So it's it theoretical this is question a good at point.

Operator

from of And Wainwright. comes Pantginis with HC line question the Joe our next

Joseph Pantginis

Nice enrolled regard see high Bill, I have that more with to AML criteria you've might XXX potential do a to study. second question think the so on getting exists patient, the see in a the My the the you since study? patients predominant is, MDS are performance enrolled question you patient. stringent that

William Rice

enrolled patient. just In patients an is we fact this that MDS

Joseph Pantginis

one. that besides No,

William Rice

market difficult find only one dose forward, going and early that's patients and great two believe the in So all, in levels, have these we after MDS, high but a to lower very first can to each patients we on in AML really performance which patient of is on because, go AML. we of wanted yes, particular we so

we a looks turn clinical to did and for status. performance So let's patient go an we the and like that found MDS has hey, said, sites one great he we

well, there, in markers. dosing for actually originally PXX looking the want further we've much we this, These activity patient be MYC independence it is also looking parameters. inhibitor, MYC for measuring we'll a MDS thought, and the than a this go patients but variety we'll we have a first we more know patients trial variety of inhibition do to transfusion AML because different in collect that went as may MDS continue into we and of and So everything that further now on, and into completed we both this drug, what's hope and

suggest, get based for we're on you MDS thanks and continue going that to doing very on. So should And as there forward. we coming happy an

and question. Joe, it. We a today, appreciate Here asking

Operator

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

John Newman

questions. had quick two Just

mix very your for CG-XXX NHL. what here; whether The obviously patients on or study the expectation would allowing first with a malignancies patient CLL, be SLL be one you're the it B-cell is, different

opportunity quickly. stated, XXX, you you're to as do longer previously be And you AML, you the wonder but dosing sort something sometimes for don't a simply to if get expect that if you response one XXX, may the in to that of dosing, see then could protocol dosing for remind will patient not if And progress provides I an a us for an else just for progression. then, or than moving while, MDS if that potentially do will patients given know think other. then may dosed you curious they now, of quickly doctors patient would those the as assuming have more of that Just AML? as

William Rice

Yes, good questions. two

first wish his days high to level that dropping. in It's of had that possible XX% him with have days the Good trend and dropped MYCs the forehead patient a dropped is, and So might the said, month, collected and because left those because was on second then the we was not down had responses. to dose we even there kind SAE But patients, by he two events, is, physician once if PXX XX these it seeing of have and MYC that made had on for and there. slapped an I ah, clear further is us. seeing had off could present very you're they that that and were have so XX XXX, flip have sick we that death The let's That patients might after data, our in are patient because leave may the through there, benefit with or pure it's risk adverse patient weeks of negative conjecture. -- been XXX later, side a but took not necessarily benefit turn example no physician first. I

decompensating leave patients. the the patient doing patient patients they're the the and are and any as benefit, and by be So an that a now in happy the study at higher -- dying again they'll there. but that MDS thing not that this will long means, make the patients to physicians are patient, as the happy day here, X, In judgment, did not we're data receiving MDS collect some see be them prerogative, the they're the there, on we'll on into well physician leave them getting and especially second benefit it's hope we're the dose, these right to to we

the we have be hope on to this. right, expectations All you what or to we'll see updated the type there. about that one longer, we'll -- label. open transparent stays patient as we see get. XXX, It's we So patient the of collect data we Again, very We try and to XXX what other. keep for

go looking coming something cytotoxic some are what the they're is, those as and already and have for all initially, so that drugs, patients drugs, the the of out they if to me, getting tend much I patients, to hearing CLL of ironically, lot ibrutinib better, want decide to the types to filled venetoclax, others, people types are They're venetoclax. the clinical area now we're presenting failing as on patients expected R-CHOP, they the to excuse therapies, kind these all the there, a AML the of going are -- at CLL in look of and drug you they at more and we well traditional If B-cell know they're or than on because different. our look of have we going different those malignancy to sites both the focus

with to keep So that, be most and that's I The we're something but eye patients think that going trial. CLL dealing get we're an on this on are respond not there But many well. many just I common they kind tend many deal too mean, afraid -- after because is one patients DLBCLs of DLBCL. to go companies of plenty we'll to out able

out they're be these in where see get little can DLBCL of have we Perhaps a higher to going which I but us. for turns populate with that the as than when can though and when had we more we So doses, cytotoxicity colonies our as those is patients ICXX and clonogenic nanomolar the feel assay, surprised potent a than real all more try with that the of It bit we ibrutinib. may then ICXX to available. still was think active can our have is they higher we versus form the cancer the was times each malignancies, profiled we deck, single-digit other ibrutinib. when actually types an range but a did, different types XXX you more drug we other, we the that got assay, cells grown slide we in in assay, X,XXX But of B-cell but this all effect, vitro, DLBCLs a on stronger still into

of to the you the different a institutional be the tend hope both may we lot see to kind those activity of to the to types have we that's different community why because patients it major and unusual, all comes of a get sites, major institutional just against sites, patients, here. So smattering these at and that into want of go But clinic. sites, have diseased we'll a again, all the what sites, get we the to

answered So hope that your question? I

Operator

Cross next Trading. your from And with Jones the comes question line of Matthew

Matthew Cross

both far for in my progress with questions. thus the candidates the this lead and taking on thanks Congrats clinic year

anticipate mentioned that dose for you cohorts patients. following four expansion you'd of moving malignancies B-cell into escalation CG-XXX, So

as as cuts those to of mutants, phase? envision simply distinguished any lines CXXXS along based the And I would based this on could etcetera? cytogenetics, dose the such escalation prior guess So for you are these indication or data on you potentially grouping be treatment, stratify planning and

William Rice

your and the So we'll answer that yes then And and one. one go to next is, let me that yes. to answer

to maybe FDA back the to what will on to four data. to FDA instead time and separate expansions, allow when we at the recommended that no, we'll do we separate submitted the do have of we we choose going we and you is patients each, said expansions XX The IND are the can seeing each population and and have XX XX depending two you with patients you're So activity, came the it's X, and go benefit such those to patients II data to type on patient way can registrational you a collect in that if on strong Phase you expand medical those enough patients. the truly depending benefit studies, into if let in you that these and need

that of lymphomas MCL, SLL; was the and data analysis. were all group the So lymphomas third said DLBCL, the was indolent CLL, group the the our all the we types and one; other they then as fourth, together could categories that's combine and data for second

have that we in So there, we If may activity this if was but see than that. better see, population, CLL, each we SLL. expected, of say, great we great as could also get but activity Waldenstrom's, we after a with these, ever pursue let's say, might may let's go CXXXS, we

FDA the depending latitude us we've as of in different lot sub-stratify well it based the do a allowed be and data, patients will great on on parameters in four to and way then areas, patients as in gives more to that the be but So these depend to able this seen both categories and within of us on to this the select clinical data vitro trial. those the the genetic the do

we all and depends on drugs work in for fastest, whatever flexibility latitude we value the and So data, will go think the speed, after build less patients but but it more best have to haste. the

question? second Okay,

Matthew Cross

enroll, trajectory with considering would you at AACR much we're to very is come venetoclax, that in is and cohorts or hope Is expansion the this I this when setting? could And one thinking? mean on data explore to malignancy that separate so thank preclinical the you in that where a resources to was, available you in given presented so current And trial for, your this based when clinical the something that for for the XXX makes start sense sooner XXX, initiate B-cell clinical second clarification combination later helpful.

William Rice

the yes, is I one careful want have wants associated understand toxicities as possible something drug profile drug your the is understanding into active that your of combination. the is parallel, to could a are to activities yes, drug we am I are and because with provide an the drug venetoclax in combination run to We by associated are because the for definitely you your agent world major every prove also you to future in with gives we value, could us it what it in tox rapidly say, drug to what be will saying, single these reasons, is drug, with the combination I for think is two tremendous but to sooner. be indications everyone itself. indications. to used what if able as In that with And going explore that come that perform were This these the venetoclax.

overlapping So do about like -- based And we again, we've know see it seen what studies animal don't be in to venetoclax. will that. to toxicities we able on us would we and what give

moving forward. So we think a could combination great this be

select escalation allow if if probably all were study venetoclax do were to a of dose we drugs it. out out the we So combination FDA there, would and there for that to

see as yours. our clearly our are going and ifs but thoughts enough disclaimers you in where think there, enough? I Fair that's can

Matthew Cross

No, seeing you how enough. pans looking I decide. it to the and appreciate where guys forward it Thanks again out for Fair questions.

Operator

Riley B. next with FBR. call Our comes question [ph] instructions] [Operator from George

Unidentified Analyst

alluded multiple Thanks these update. mean, approved criteria trials there, out for question A and on prior I'm drugs both all I XXX. for for actually are a hematologic in your to wondering and are already both detailed XXX. very that for the and therapy you helpful XXX of under-study the malignancies. what

William Rice

in you, think therapy, tell I a long-winded we of All I will detailed, we're just but a right, [indiscernible] very allow us prior will terms heard I offline. euphemism when So so, that's for agnostic. to

that we've have if are in have to and the even drug. FLTX patients multiple patients inhibitors, So patient for we vitro who inhibitors with mutations models demonstrated other want actually respond to FLTX, in failed still because other FLTX the AML, in resistant samples our PDX they and they

our would that agents, those. hypomethylating they this. on If failed drug work welcome we seen we've still So,

with we to is that in literally have we occurred into phase. in of sure AML have would malignancies. type but And for get that to activity, can we want certain happy the failures we expansion the B-cell same that guide be the broad our data to So true take any populations date, us so we because make that then trial

failed they are all unusual, And drugs one we cure that if if us those of -- kind for have rather of in populations. today, all going approval CHOP, terms inhibitors, drug can accelerated on data. of venetoclax, R-CHOP, So the those covalent we're than BTK But patients. more venetoclax it's agnostic; we that activity. we demonstrate is have we no these we is again, can based No all it helps but say fact, who based at malignancies think humans I exposure this comes that patient any in have because no for will the can a we'll say, out turn in data this treat on hypomethylating with not patients of let's would want well, patients, want failed we those But mutation, but all drug the the we we other the we preclinical in B-cell patient we to may treat get, in those also of venetoclax, with where target are that the the point, another of non-covalent BTK, patients. combination, PK, of with and believe all to activity -- we a type it hypomethylating, mutation would BCL-X for ultimately

we'll get try good most that hopefully, select a good have exposures, analysis? we'll fair that to will Is the up, exposures if don't get sensitive. those to buckle as we population. are be But to agnostic and the So patient

Unidentified Analyst

that, on I as other -- other more trial thought early and but were, a it line, scenario, I and maybe to question front too but says maybe you to also it's two, a to move mean, actually as just to be that's want the multi-kinase as kinases, the you in wanted drugs, one first-in-human to do to that mean, paradigm typically there. about only than got think if design, brings have because it the up you if of good the it Have this best that. comment type case you if targeting superior because line two you're drug that? about I the

William Rice

Well, too early. it's never

You collect the move up have and it data the to line.

that, we but present course, the have in early of what malignancies. to to to thinking would if AML the So, about that's Along patients, AML those the the with that. as the effect on earlier, as collect guess world it we're if the and to combination a both overall we data lines, and talked toxicities study B-cell FDA, well, we do about as well apply justify and can venetoclax to

that be we'd to so, And quickly. able hopefully more move up

The II thing patients other get Dr. our recommended Beat with AML trial, I take AML Phase in we work diagnosed. a to want has Phase initiative, we that which Brian dose, once and now which have just The Druker they is, to been

then patients, of been that set patients. other naive agent with are treat combination these with So activity in drugs line never treated your to show drug with and single they will with first and

the AML we Phase yes. that Beat that, access Druker to out yes, move so, relationship We'd to we a only hope do into gains are up that trial Dr. possible. but II the also us as to thing allow that the we have quickly we us get advantage And once as like start take with Data can refractory dose, will with patient. of relapsed

you. with agree we So

Operator

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

William Rice

thank joining about everyone odds opportunity assets. to We're for we're for for options and to you with patients patients development clinical achieving with treatment diligent today. the trials, shareholder us value long-term improving lead maximizing advance the committed two these benefit All excited right, the malignancies. in now of With compounds well, the of these

say, have haste. have advisors. critical always this errors, speed, wonderful our juncture and staff, researchers and stellar a very evening. We're group a as reached of shareholders not We no with the you pleased to unforced So Bye-bye. and of support thank

Operator

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

day. You and have all may disconnect a wonderful