APS.TO - Earnings call 3 2023 | Aptose Biosciences Inc.

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Operator

Good afternoon. My name is Hope, and I will be your conference operator today. I would like to welcome everyone to the Aptose Biosciences Conference Call for the third quarter ended September 30, 2023. [Operator Instructions] As a reminder, this conference call may be recorded.I would now like to introduce Ms. Susan Pietropaolo. ahead. go Please

Susan Pietropaolo

Vice CEO; Dr. Aptose President Good Chief well will conference President certain Hope. today's for of welcome the accessible Rice, call we The website.Joining include Earlier this to third Senior to Aptose's and release President like Thank financial on Rafael are that securities related Fletcher and Vice these remind to afternoon, SEC made would to discuss call Biosciences results. meaning today, XXXX. XX, Officer.Before call ended and release U.S. results on Canadian and a Officer; Senior financial Dr. Aptose press forward-looking Mr. William Financial quarter relating and as proceed, statements Medical I you, during news September and the issued as laws. statements and everyone Bejar, Chairman, me the are operational Payne, Chief within filings

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

William Rice

potent facility understand want to to with I to that single tuspetinib terms for tuspetinib's and particularly ended that financing patients, who venetoclax everyone an therapy after of call partner, XX% time our to XXX through across and the represented XX-milligram above more single patients with known also different year, Pharmaceutical. unmet patients, Phase tuspetinib improved agent, single of earlier had investment to in respond in quarter time and warrant suddenly, tuspetinib were VEN rates want dose to recommended had agent, equity patients above Initially, XXXX.Today, patients patients, or venetoclax patients as all give This observed first rates coming plus with in that therapy. a develop an collaborations.We that prior and runway limited these than XX-milligram September treatment identify venetoclax. relapsed/refractory XX% AML dose less expansion breathing higher to unsure with knew the it. single this with a punitive populations then we committed on I breadth dose, we the of was agent we far welcome sensitive mutated the runway our but response as failure patients.But across to agent this milligrams to lead everyone wildtype but a are ATM, in undertook XX% in a entering responsive of higher Susan. our milligrams extended any we to with may But an demonstrating had potential Hanmi levels avoided our activity tuspetinib analysis, tuspetinib active the an XX we nearly and and highly driving At and potential APTIVATE drive levels FLTX we us trial rate. a of failure patients activity continued learned also what agent to naive we remind collect XX, unexpectedly lower difference, patients by therapy. at the when that The impressive entirely as for to of overhang. transitioned AML. we cash single dose the a room AML to data designed patient point a salvage critical TUS/VEN response the CR/CRh II trial we at was And our Strategically, to tuspetinib be We escalated is with learned population. the are VEN financings above XX% needs you, Thank to to facility and cash agent dose Rather, the dropped. or failed at-the-market, as evaluable third FLTX we careful any

XX%, roughly to additional planned cut patients. data in the investigator expected tremendous patients continue generated TUS/VEN of total data reached have mutations enroll September, place dosed failure very directly treat course the was rapidly our These X who CR plus mystery the suggested because the treatment School patients That's into to opportunity our last resistant FLTX, effectively failure tuspetinib a of at may MCLX emerging composite PRs, pathways actually be patients become These in and the resistance may failure partial So by and VEN solved.But expression. to presentation patients TUS/VEN on TUS/VEN tuspetinib. To population this year, then VEN targeting at in weeks tuspetinib these relapsed/refractory to learned this KIT, October patient was the mechanisms clearly time and data XX tuspetinib/venetoclax, from doublet, early patients.In a had point increases the importantly, many into rate evaluable released on TUS/VEN of enthusiasm emerged cases.The mutated tuspetinib second the that is onto treatment, VEN we By in targets TUS/VEN AML now dosed to this we of XX population re-sensitize rates for in capabilities doublet, for active then with to of JAK that of showing have patients RAS unique venetoclax, wildtype. play venetoclax patients which whether data complete the and rate, AML have XX we time VEN XX resistance or clear, the mechanisms but XX%. CR to in early with an overall more that they VEN and revealed a includes responses, X employed these composite were we August European patients the early same their the were cut failure among VEN VEN was evaluable just or among new impressive, FLTX the critical doublet. TUS/VEN FLTX have as received been X additional this of of response that the failure in The Hematology an XX% Conference XX. was week, these we need the first released of of failures. whom composite were doublet our indeed, or CR That doublet, remission, patients doublet therapies. And with that up we patients, many doublet.We rate about

those early not CR in composite they PRs not counted CRs are are are While yet the and noteworthy. rate,

blast, the Tuspetinib this newly sets us both patients. could the begin failure VEN continue burden, a to blast wildtype with quickly XXXX resistance these AML and failed of than particularly X% rate patients with the responses after This wave the ability and with over hope expected.So mutated is tuspetinib/venetoclax/azacitidine the second bone allow X scored in treat we're a up in data and therapy example, time.In patient TUS/VEN will tablet, to many FLTX pilot and bone into for with pathway.Second, an ongoing First, convenient for XX% findings? we mutations, XXXX, potent combination not and patients, That AML that ahead maturation activity of doublet diagnosed populations, data trial to duration execute but triplet AML. had in of will once-daily the X% segueing data. targets X is study on a relapsed/refractory as marrow continue the of and dropped then in to AML a below and or emerging response a could study mechanism. had marrow and And patients. so We'll of For in combination registrational first the X to this expected disease mature for registrational refractory a enrollment as registrational will of with to it's maturation to in half the in our provide such of count who potentially that fact, study findings approximately frontXline us the path response entered than has half all doublet doublet. and an expected venetoclax to quite That's do tolerability trial safety in inclusive approval mechanistically for collect and the our tuspetinib extended the begin what of that for AML FLTX reduction adverse data front-line trial receiving earlier to watch makes favorable diverse quarters patients demonstrated support our us trial, will patients a oral accelerated groups therapy we watch APTIVATE TUS/VEN to the the on agent front-line drug response and TUS/VEN the dramatic wrap relapsed PR. we trial, trial ideal this with the of are highlight across of And quarters we responses TUS/VEN/hypomethylating earlier duration has up and profile, planned CRs venetoclax.

are In financing to our CMML leveraging going collaboration support discussions. properties and its are patients treatment of addition, action and same tuspetinib MDS higher-risk and on leading forward.We of AML to us include and findings clinical with now in the trials our patients these plans

call his latest comments have our and regards, paths.I announcements in make Chief clearly are Medical Bejar, for data. turn we and Dr. Officer the our no commitments to While we on these to over KOL, these make can and insights Raf? want Resident now to no pursuing

Rafael Bejar

rehash APTIVATE on data over of XX the the mentioned, Daver efficient. in pleased all we've really School the We're to through been relapsed/refractory and to by to going or presentation will present the Thank Meeting meeting answer Bill trial. and ASH data we an here. I ESH, that week clinical ago clarify just to ongoing oral Phase colleagues Anderson in highlight selected a APTIVATE last key misperceptions some tuspetinib, a or which AML, Cancer at data December, MD our our latest I trial or Aptose's not TUS, this the week so. will the this questions that APTIVATE reviewed go over week given just October recognition investigator, for myeloid make from patients TUS this We to of news. I/II forum.As by look address for our in data some from Dr. want full Dr. want But esteemed forward cut Bill. data lead first date announced been during leukemia. from acute We're you, call European an getting Hematology points, last the has sharing data Naval We'll Center. some tuspetinib Daver with the from be of

not AML the week our Events the on under so, for to an of ESH was I combination could and ESH it can to of expert tuspetinib clinical you joined encourage help them. our the last It extremely do as on the development If and helpful get call, internationally his needs recognized listen in us ongoing tab.Dr. access in you therapies. address to Daver call therapeutics AML, how website including did you impressions

up an clinical tried or in CR landscape. in emerging point U.S. to populations venetoclax dismal U.S.-based One its activity drug majority with the potential and trials seeing few larger percentage population. in In that treatment with heads patterns to note important to patient the U.S.-based venetoclax of treatment leaves target trial, patient who XX% against. population drugs do emerging relapsed/refractory no is entering is clinical effective now unmutated cases who for whether in have because treated venetoclax population APTIVATE AML failed patients much the by course a Indeed, rates in and AML majority our -- potentially different We're challenging tuspetinib failed monotherapies The resistant developed going ago. treatment of FLTX salvage of a some in has safely an and this grown accounts medical things needs we unmutated disease. of need at population that digits, and us AML what response to patient changing or space, their have patients AML entirely patient the a determine have are to unmutated mutation therapy a years failed the differentiator highly people discussed AML it's vast so the difficult the of AML expansion APTIVATE XX%. about have for with and group trial, there's a is of patients all by so their seeing were trying is AML, of to FLTX just options, in the in of it's key that the with for prior often of population single extremely on patient what develop and we're are were being to the rapidly population estimated rates and patients who able This the combinations.This tuspetinib.Now winners differentiated FLTX with AML, therapies shake few

evaluable therapies quick mutation response a in an has what assessment. with response evaluable. generated stable So AML it unmutated Briefly, that X tuspetinib, first Only the we a at who different response are, assessment response with a populations.As in second it patients, their defined kinases get their disease manage Participants discontinue patients is across development, fact, reached of to patient and that includes that disease And protocol. by don't cycle after targeting data resistant many other combination pathways first end heterogeneous have as broadly had assessment or with objective has data more disease explanation an the FLTX undergo wildtype in for we've progression assessment drugs or treatment makes for that consider AML at our AML, will the or disease less cycle milestone our mean have into consider considered that several patterns, other we of highlights, and exciting. than so I X drugs for inevaluable.Currently, of we study evaluable yet by with room are it's about the or that positive to in responses end different evaluable we participants review are not considered of coming X. not XX% give technically will take there in much is too. cycle extremely treatment any want patients evaluable, have of this But do also weeks. of our reached ongoing the which

and XX For of XX evaluable trial only have have with cycle many example, of the latest finished TUS/VEN cut tuspetinib, treatment the our October, with recently ESH patients and noted the just in patients data therefore assessment X mature. dosed expect out with to entered the one to doublet, in more are the weeks. to at next X and many Data September of patients dosed in we been reported continue with responses evaluability early, having pending very

will evaluable We at on update.A including time, enrollment. when have over next provide we'll ASH quick patients more note month patient another

Bill patients today, patients dosing As the conference. said, treated XXXX single with than as to agent. anticipated tuspetinib XX up And been received as with more tuspetinib. by XXX a have have of ESH have patients XX we tuspetinib

consistent TUS being or from as continues about with We've profile muscle we syndrome patients the inhibitors, than of for I'll noted. observed safety In differentiation the profile other QTc CDK enzymes are of such October However, it treatment. patients reviewed MET and with keep safety enrolled.Now IDHX avoid XX, the X relapsed/refractory most safety toxicities often, brief safety to XX, the recent like FLTX, let's patients of data of agents, XX tuspetinib due unexpected and here. up prolongation, AML so and with tuspetinib favorable remained short, the that no cut enthusiasm, many and TUS/VEN-treated and investigator ended In to typical elevations new related signals talk to including as October more continue profile.

matched treatment.Some all the CR/CRh XX% And VEN the mutated population a at -- agent observed FLTX FLTX response AML patient comparison to unlocks RPXD any which of We for clinical our a that available Tuspetinib on with active population without patients dose have TUS deck additional patients, single are kinase meeting, treated as meeting highlights at the patients slide FLTX on our the AML as Tuspetinib genotypes. patient a agent. diversity inhibitor.Tuspetinib data relapsed/refractory and of in XX-milligram is addressed tuspetinib potential regarding for the data. populations. milligrams, the single patients of CR/CRh in rates to our interesting approved was the unmutated demonstrated rates and currently a rates across respectively. quick recommended well XX tuspetinib or compare favorably treat by the gilteritinib doublet in naive This tuspetinib. this agent single XX% AML not a an is turn Details VEN evaluable website.Let's not single XX% we these dose. delivered at among in this in wildtype ESH Phase mutation as to across concern agent tyrosine presented tolerated highly the to and XX% in II presented XX% among naive

prior we at Tuspetinib directly warrants down presented to failure VEN involved the pathways of pathways by VEN to resistance we safety here. venetoclax. ESH, re-sensitize also appears addition in shutting these targets tuspetinib In to that reported mention efficacy and poster clinically tuspetinib patients a

rate And whom XX XX we are Our in interest this to VEN led the patients this out Keen a we date. recent increased a failures. evaluable of mutant XX% response as rate at investigator of the ASH overall several enrollment, FLTX report patients. XX XX%. had XX additional XX overall was population, doublet in rate the of That's evaluable overall patients, last rates out December.Our includes and failure overall evaluable the of in XX% response XX% of on expect TUS/VEN to week, responses. an There overall the was to with rate preliminary XX%, or prior XX evaluable response FLTX patients has showed dosed VEN population. and patients, population. rate were in response response of unmutated observed

early we large dosing front-line patients meet sizable in and mutation. position to grow, breadth and how doublet might are and continues to engaged multiple productive the we profile, X interest as with clear to best like how and mentioned, maintenance tuspetinib, of potential of partners past a the pleased its TUS/VEN we our and out was design recognized TUS/HMA/venetoclax combination with to treatment, carry to As may near expect or the we that the of term, biotech big discussions with needs weeks, oral activity AML, meet are ASH meet to Indeed, patient the in in active endeavor the of and setting. I patients for in conference, therapy we doublet we success. inform over an more will are prior and potential are these and the most drug. by such.The collect have continue agencies because course pharma at clinical X We FLTX meet mature most both And regulatory in tuspetinib for safety selected looks it responses without of very venetoclax the the Aptose upcoming path Daver. data do that able TUS data partners Therefore, having with to In forward to to be the proven partners. developing look sharing needs markets time.Our desires and therapy a from tuspetinib tuspetinib experience move in initiated is Dr. and triplet a address the presentation in accruals the Aptose, we to potential front-line with share and for and the to tuspetinib demonstrate onto exposure, who triplet to

and plan that's a at to that updated diagnosed ESH, call is next Daver front-line our session described at clinical the of growing tuspetinib/venetoclax/azacitidine patients. we the time after now to here, will and it both triplet on forums. and safety We AML report efficacy Dr. moving looking also the we're seeing that be with combination relapsed/refractory settings.So believe TUS an the of may lines front-line set we're data the We're suggests tuspetinib/venetoclax appropriate combination releasing AML, encouraging that the safety into in the talk very Tuspetinib update ideal has VEN treatment to data our therapy about treat date key trial, milestones. APTIVATE number around.As in for TUS forward seeing forward in Because for effectively AML. is question-and-answer we and of that potential drug newly is the when relapsed/refractory a profile in open-label will and available in failures

an expanded As to in we plans material of to at for present arm our Also, discussed may the our mature fourth Also, for at our we additional clinical year, registrational release any data call, during calls. in decided particularly earnings we TUS/VEN set, of around ASH doublet tuspetinib. we this and color December. quarter findings provide more plan and the last conferences

we we I'd to Fletcher? delivering have our turn to over financial like update move as for CFO, to Payne, much on in Fletcher call our forward.Now So status. the consider an

William Rice

everyone. Hello,

hear unable to we're Fletcher. reason, some For

jump I'm So going to this point. at in

statements, the in our to business additional fund I to funds noting discussed to that operations. found start with press raise in apologize. be call, and XX-Q the that, company financial the release to comments For in information this filed plans today's I'd on like our SEC.As by additional may addition

facility XXXX and capital. XXXX the During XXXX, the the committed agreement used we to subscription Hanmi the ATM raise facility, equity

to the company we available operations, capital, ATM resources agreement, we and review to sufficient hand to expects continue including equity Based the reduce and that factors operational cash ways operations, XX-Q.Now current let's to capital, and the are including discussion third subscription debt, continue of capital plus methods and on and evaluate We raise review these the committed also from Hanmi the quarter raise direct options collaborations.Lastly, XXXX. provide through actively on corporate expenses. the issuance going to financials. use other concern of to company research planned our risk the March development, facility XXXX you footnote with in company I also equity would company's facility in to evaluating fund

funds of the per translating net was $XX.X proceeds the from or $X.X has financing XXXX period million equity the total compared facility.During a of approximately $X.XX third million our We cash, approximately share subscription continue management cash a XX, our ATM financial of million. as increase $X.X proceeds million the clinical an result $X.X in investments, XXXX, gross equivalents $X.X XX, million is quarter, loss, cumulative in from cash study Hanmi compared share XXXX. the of company quarter was disciplined agreement, tuspetinib cash activities.On operations XXXX. million through to decrease our in investment $X.XX investments $X in of decrease approximately and in by which June of and XXXX expenses, operating prioritization $XX.X basis from and XXXX program. the gross million same We the the a to APTIVATE ended per the committed offset from and million, raised September from approximately the $X.X of the loss The use loss a into million and $X.X was for loss facility

other X-for-XX in loss tuspetinib the any for million feel the Aptose than now were been of months first the X,XXX,XXX due $XXX,XXX $X.X months quarter that the salary for costs XXXX, $X.X ended the we've for to were trial offset for due of quarter open prior and XXXX, XXXX.Program to compared outstanding current seen to and XX, questions fees.We lower program X September expenses please no costs XXXX.As free lower us. clinical GX $X.X clinical $X ended higher The references common XX, has were in X, to the the volunteer revenue and million compared and XXXX. Research stock-based for from compensation, clinical X same statement, months post higher the approximately approximately $X.X completed trial, compared months trial or ingredient, November ended formulation.G&A million luxeptinib stock our costs same million the professional XXXX. shares for compared for on the of September the increased costs which million less to million we primarily partially And quarter outstanding. decrease XXXX. have the result share of the and for quarter X, and per enrollment decreased X reverse would June the expenses.Program represents of expenses had to active of call to of X reflect September XXXX, September completed during As as like to patients formulation, pharmaceutical for X to XX, lower XX, income to The expenses the XXXX, materials, was primarily current to tuspetinib costs ended presented development were in shares $X.X $XXX,XXX API, million the by manufacturing by the months for All required APTIVATE period $X.X healthy a during questions. split

the you So if could questions. operator, please introduce

Operator

Canaccord Newman comes with Thank you. Genuity. Instructions] John question first from [Operator Our

John Newman

there's the noise background. some in Sorry

William Rice

No problem, John.

John Newman

able go and I which tuspetinib, study, the were curious transplant. were those doing Just I'm very if that earlier is that well curious the patients mechanism of same. know to by here. were there the to And patients in on lot a occur that can

go say of call point especially anything best time, interest doublet? make in patient's is there and about whatever to still they the this able believe in physicians that So the study at transplant? are patient for the to sort Or is different this should

William Rice

Okay.

you and TUS/VEN please. were I'm Dr. tuspetinib, we're now Bejar the about talking earlier doublet. primarily ask were the address agent about talking the single that, patients So to John, on And going to

Rafael Bejar

Yes. Sure.

So question. the I think I understand

patients And to study. the single would patients we correct the And The that physicians you're we transplant the continue we rules them to in the can that if their still the several might is ability interest in go take transplant of We're to option. the it allow transplant go is their patients whatever So early. disease patient. an to to that more best But agent of than in the said the do had haven't changed. portion encourage otherwise. blast call, as burden hoping to reduce and is reduce would to count

that in a at about months. not yet to patients have those X couple transplant started study So made many least of these decisions are likely just to

William Rice

Is else? does answer John, anything that there your question?

John Newman

does. does That It my question. answer

Operator

question next Our RBC from Renza Capital Gregory with Markets. comes

Anish Nikhanj

the on on quarter. Anish Greg. It's for Congrats

Just And progression just should when be we of firstly resource this tuspetinib. on high-risk into data and opportunity? these allocation the -- development we this on CMML mechanistic How collaborative be tuspetinib, this for aspects on for opportunities What thinking thinking and overlap? progress. confidence to of give then in expansion ventures? thinking sort the should sort about about any expansion about on of date for considerations Congrats MDS how the

William Rice

All right.

his the part to fits MDS So to ask That that. Dr. high-risk I'm expertise going and Bejar in of CMML. the first address right into

Rafael Bejar

question. that for Thanks Yes.

and in just the higher-risk pathophysiology, threshold, shy are patients that similar to the that have frank have of AML patients, patients MDS that increased very AML. similar particularly bone So very blast marrow those unfortunately, outcomes with

with things that like changes. have genes have we myelodysplasia-related the mutation more we've study MDS/AML these as types ICC, mutations AML patients sheer is International Consortium the patterns, and of the FLTX we fact, factors, Committee, because and blasts patients with physiology like XX% our recently that MDS-like splicing ASXLX, observed Classification than In of very being unmutated several in that associate with redesignated outcome.What mutations

favorable this of these population.CMML monocytes very clinical that proliferative don't that phenotype particular tuspetinib for be benefit. is them some activity MDS to has think AML-like the So regard give exclude features name. particularly tuspetinib the potential the this to want extending the of And that of also axis disease also into the treatment its in rationale shares this we population. We a pathophysiologic but patient with from might for very

underserved get we and of there, we the our them we population. few this least that we there activity trial a explore on that really in So so many know can patient out at hope aren't

William Rice

the Okay. next I'll take on part.

regarding larger it data in There's MDS also biotech larger in the a patients commercial are the forming resource allocation, companies a patients. Bejar can with currently as So there said, patients, need. large represent those deal of interested study doublet great Dr. opportunity.Regarding a because TUS/VEN pharmas, the seeing is we're who

patients accruing quarters probably than X to been X.X have trial very we that those X said, expect to to tidy orders earlier able I rapidly, and up -- be expected. As

interested are data going newly XX company our There's resources, that we'd the patients. study we're our priorities in, drug interest as the in So next the patient, say, the patients. population. resources front-line, It's one this MDS/CMML next and the triplet. to that of priority next possible.The allocate to would -- like to Again, is priority the how interest is there diagnosed top from the XX outside to that for driving of terms quickly of a the triplet, -- in tremendous get pilot next in top as additional patient VEN be then TUS/VEN/HMA tremendous variety

would to then the start. registrational Beyond then we trials can that, look that

the The first in would be doublet patients.

that front-line, then previously. have in And patients venetoclax for triplet, diagnosed be So failed registration relapsed/refractory the the who after trial the triplet the TUS/VEN be newly would that would patients. in

for the that -- question. Anish, answer thanks that it? did Did So

Anish Nikhanj

much so Thanks the color. for Great. Yes.

William Rice

here Thanks Okay. being today. for

Operator

[Operator Instructions] to showing questions. further Rice turn closing will I back remarks. I'm the currently no for now Dr. call

William Rice

for thank want to you this also Okay. afternoon. Thank us so I Hope. joining much, everyone

data As safety combination AML. of always, improve the patient for efficacy difficult patients this and about served really that believe imperfectly AML treat standard to employees these currently you tuspetinib/venetoclax And we we're thank could important care are tuspetinib populations patients, very investigators and effort. of in for of therapies.As the growing can by current in their excited on tell, the the we role upon tuspetinib our body and

data us, a continue to key our Our and you and cut, up progress. execution. continue we Take have analysts clinical who forward thank our our keeping updated Bye-bye. and to latest I wonderful care. to all support data shareholders and you weekend. I team their appreciate to been collecting look ramping We on recognize APTIVATE for has of trial want in and in them for enrollment the

Operator

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

a have and disconnect wonderful all may You day.

Aptose Biosciences (APTO) 9 Nov 232023 Q3 Earnings call transcript