ONTX - Earnings call transcript Q3 2018

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Operator

Good day, ladies and gentlemen. And welcome to Onconova Therapeutics Third Quarter 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] Later we will conduct question-and-answer session, and instructions will follow at that time.

As a reminder, today’s conference maybe recorded. introduce for to conference, like now your today’s host Dr. I’d CEO. Kumar, Ramesh please ahead. Sir, go

Dr. Ramesh Kumar

Liz. and Thank third morning, Good you, everyone, results quarter welcome call. XXXX our to

President; are Joining who Woodman, the Medical Steven management from Chief joined CFO; team as me Fruchtman, Dr. our recently our Officer. Mark company Richard Guerin, and Dr.

California property us in quarter programs intellectual towards patent the our was achievement for Hematology place XXXX abstracts The enhancement of advance XXXX. at through position X by patents protection third and from of include to XXth Acceptance the of many by to Annual four geographical Meeting inflection milestones Rigosertib extending to the marked important December presentations Rigosertib and These taking objectives, relating XXXX. expanding in Diego, enabling X, of USA and coverage the value Society XXXX. Expo of American for San the our in

inhibitor towards Biopharmaceuticals CDKX/X+ARKX in novel with ON HanX pre-IND our at in advanced is developed program IND Our This China. an and being is moving partner XXXXXX stage XXXX.

our President pleased U.S. Clinical was leadership Novartis, further Development he with Medical most strengthen Senior CMO. of senior Woodman of are We appointment recently team with Rick as served Affairs. where and Dr. Rick Head to Vice the as and Oncology

recent the the we’re in and these We program. development Steve a will the sheet development of to turn value progress joined Steve? Rick forward with for inflection I position making points Onconova of discussion call many toward development. business strength has valuable to clinical now And near-term our are further balance contributions continued over excellent that to Rigosertib. pleased and our we his look our programs Together developments

Dr. Steven Fruchtman

myelodysplastic risk are the program lead continue progress that much, very Onconova, the clinical At respond INSPIRE to progressed very X INSPIRE In as the and pivotal completion inflection or syndromes points. include making second-line an who about XXXX, for excited you our Rigosertib a efficacy nicely clinical Thank patients agents trial analysis programs have interim Azacitidine X also with and our These trial important we’re MDS in differentiated Phase trial. Decitabine. a safety high with of increase programs known a the announced pipeline preplanned advancing while we hypomethylating ongoing as towards intravenous such January sample leading to be ongoing on failed in our to strong we pivotal for very of Phase to size Ramesh.

in this trial second We expect half the to data of topline and XXXX. full approval to provide complete

product or programs, Protocol We we Japan of and high composite the our X this and combination also is Rigosertib and the and refractory have completed, U.S. includes SPA and Azacitidine Phase will MDS for or proposed X trial patients medical is this Japan, endpoint. pending X Rigosertib in have one, is design We trial for which follow address The needs the trial pivotal X health referred Hematology oral with year Special HMA process to high-risk MDS second, at two to filed as by to conduct both similar Korea combination Phase activities. to Meeting, Azacitidine with oral be patients a the Rigosertib be will Rigosertib of a on clinical the with injectable INSPIRE trial naïve upcoming unmet initiated presented MDS with to Rigosertib, combination intravenous The with of ongoing latter the the pivotal front-line and patients. Society ex-U.S. to will filing Phase this intravenous with be be in American naïve, well ASH who financing Phase partner HMA is as therapy. at The MDS to and negotiation the business a in Assessment trial are This combination development or submission patients may X trial be After as high-risk the HMA trial Phase the presented patients XXXX. the risk pivotal synopsis by and Europe reviewed by be under been response the has high-risk SymBio. followed end SPA with plan trial agreed and of in authorities, for ASH.

Up which high-risk a products AML, XX% as are those which of with most typically the seen reminder, MDS for fail chemotherapy acute induction elderly and marrow are address is disease and medical patients the well who designated approved are high-risk failure with The to current for bone may often patients and syndromes of agent, world Rigosertib to unmet in story, the Thus AML advance Onconova to potential MDS may to is they is transform MDS. to for the agents, patients. to the infiltration patients to why who underlying their leukemia is hypomethylating the critical of MDS marrow has There disease. high-risk hypomethylating cells in who high-risk typically standard as be with no a refractory patients. As as new need. very the this MDS succumb and associated, standard-of-care complex leukemia, bone unfortunately reason

need. those this address they unmet the their more high-risk patients unfortunately the the MDS designation. are than of patients, circulating are transforming need focused low-risk hope leukemia The X MDS support low-risk data who have patients. We But to have in than There to patients presented most Similar of trial bone patients meeting. and MDS high-risk from due have produce low-risk disease a ASH also with a MDS red also on patients with a need risk at cell transfusion Phase acute for low recently oral these we are thus U.S. tremendous MDS adequate dependant. This low-risk MDS and XXXX low-risk medical to function and to inadequate also conducted blood. XX,XXX transfusional unable numbers suffer was typically in Rigosertib and to trial marrow

Our or for bone reduce independent making red ideally therapeutic need cell transfusional marrow their transfusion improving goal support. function their these is either and patients

actively We ongoing have MDS our trials. the participate continued across conferences major and in at present globe to on

response interim Xth response presented across HMA of data the in XXXX. International recent in with Marrow MDS the of Phase and and the Phase this previously higher trial, dose Failure X presented data safety patients results in oral initial study with We pivotal overall efficacy following Symposium MDS pipeline. of XX%, INSPIRE from our patients. of expansion with XX% reported the at in X analysis combination patients we Bone Following data XX% at Rigosertib March naïve Azacitidine encouraging in failure, We demonstrated rate HMA an ASH combination Disease the

New to of abstracts School related pleased the presentation accepted Shyamala the have upcoming As of of Sinai Ramesh Mount X mentioned, on azacitidine. already all Dr. at to XXth at of American our Rigosertib oral safety society updated in Hospital Icahn for Meeting. from we Navada present the Medicine York combination of Phase will four Rigosertib co-investigators, and plus trial of were behalf Hematology data efficacy

responses with as and the a will from punitive to to also presentations predict safety Rigosertib treated patients Additional data ASH presented. combination, well will be this clinical PK/PD as highlight biomarker at

protocol National on our clinical progress of patients NCI. dose in trial we born single-agent on of associated Based in NCI Rigosertib expect CRADA dosing concept make patients the has RAS we is funded with under models MDS, be is guidance, mentioned, the half under Institute in and XXXX. the NCI our cancer study as in a pediatric mutation. preclinical escalation Cancer with Rigosertib. and results trials collaboration the with review The and PK/PD studies with pediatric to adult first pediatric await to I key A RASopathies or for first been developed As from the we prepare the NCI put in at children conducting

myelomonocytic juvenile Regarding Onconova pathway of although with MDS, as conduct JMML one of the referred Institute part a trial National oncological also as of X to RAS JMML, diseases. the collaborative with pediatric the Rigosertib and leukemia for genomic a driven to or initiative RASopathies treatment intends Cancer Phase ,

research in a first with of NCI anticipate XXXX. agreement have We we or development mentioned, I clinical and and the their As review. half this start cooperative will protocols under the CRADA trial

addition, models at an the the JMML San leukemia lymphoma and the studied are studies expert of funded University being Francisco, center of of JMML society. California at in In and by preclinical is being

at also in is second the carcinoma centers have MPNs the A or We of investigator with number And RAS of Europe MDS in initiated in the skin where too this conducted being study many this run squamous studies. of rare makes myeloproliferative cell study disease -- Center. rare excellence driven at expertise condition. on with cells a Cancer and being for is neoplasms marrow circulating blood bone patients

many combination in related in tumors In forward there the milestones are Additional summary, for important MDS, studies activities toward programs intravenous moving Rigosertib under Rigosertib both to advancement with in of impactful the are ongoing which and solid near-term. Onconova consideration. oral are

these We With and the and partnerships. the and Officer, Guerin, Mark? Rigosertib you indications our collaborations that, turn collaborate a over will -- through call while for Mark quarter. additional looking financial our Chief thank in to results also on of enhance focused Financial remain to potential the I of and programs, combinations discussion I for will

Mark Guerin

ended of XXXX, good and $X for September net for the a third was third $X.X compared quarter quarter Net million September XX, Steve, ‘XX. XX, loss morning, Thanks, loss ended the million everyone. to

research third of expenses General third for million Our quarter to of and and the expenses for million $X quarter for XXXX million ‘XX. compared $X.X for the third the were $X.X period. ‘XX, of were development and quarter ‘XX the administrative

current the the for now I back equivalents at $XX.X cash period. the XXXX, completes totaled remarks. million, $XX.X Our take September months $XX.X million and cash end a fourth compared of of plans million of cash hand the to million call closing quarter million our of based the quarter At XXXX us $X at our net and net ended Ramesh review. loss to will compared XXXX projections. to That end comparable that September my was into of December XXXX. for believe will We equivalents for $XX.X nine Ramesh? XX, XX, cash the on financial and the his loss

Dr. Ramesh Kumar

Thanks, and Mark Rick to Steve, and welcome Onconova.

X rapidly can advancing programs to As have we incremental XXXX, in XXXX report XXXX. and we see, in many Phase expect and data and pivotal data you

the trial finalizing SPA include CDK Our objectives novel Rigosertib to and X MDS, starting near-term with oral the the RASopathy with Phase advancing in partnership Azacitidine first-line program the high-risk protocol combination directed for in compound in pipeline our HanX. clinic under clinical

to most the data opportunities our report for on agreements the initiating entire objective read hope second of remains efforts coming out expected additional in new and strategy months. important of XXXX. geographic bringing our INSPIRE results pipeline, Key and in licensing regaining the half the these trial is to the completion and Our of value. collaborations for We resources

business in We continuing With of forward entire look advance XX the Liz? also clinical key hand announce the on months quality to remain open publications our months. presentations clinical will I stage our our and and opportunities multiple like With and call forward record we studies. of for ongoing to results key Steve, and cash our developments. keeping would XX late-stage confident Mark we NASDAQ you completed questions. milestones look for and over that, compliance reach to programs, regained to scientific I track Rick to pipeline next of apprised

Operator

Instructions] Maxim Group. line with McCarthy from question comes first of [Operator Jason Our

now Your open. line is

Jason McCarthy

Hi. for my Thanks taking question.

go too giving trial into that to number on related without terms So and far? study, thus much a of the you enrollment little in detail away, the have bit events of INSPIRE occurred progress could more the

Dr. Ramesh Kumar

Steve, address Jason. will Thanks, that.

Dr. Steven Fruchtman

Jason. Thanks

on pivotal the latter death based the that survival pivotal pleased accrual you anticipate second also with full of XXX recall on XXXX. to been anticipate We unfortunate the which of monthly linked, perhaps, half expectancies data INSPIRE so second be So data we’re full of the it. our trial very short these quite and quite of which is may going patients as consistent half, we towards to has half life overall accrual events. based survival We XXXX accrual and be anticipate of anticipate and we

Jason McCarthy

the a And we or pivotal with -- the about as as study you could programs? major INSPIRE of follow-up that Thank involved Rigosertib data, centers talk how other you. many Okay. approach are

Dr. Steven Fruchtman

U.S., as have XXX of excellence the and across regarding excellence global Israel. know, sites we the MDS centers Europe, clinical trial, So The major centers a globe. have trial, the we INSPIRE over and Australia, of in is you

sites to global it’s So accrue. a trial with continuing many

U.S. at accrued, and the in Phase as again trial, accrual although, Regarding well. that centers X to is U.S. the able have combination Jason, just trial in we excellence rapidly the of full were

In addition, of course, done through being our with SymBio. in trial is the INSPIRE partner corporate Japan

Jason McCarthy

program? last talk little approach you. bit one, the All just then the just CDK more this opportunity one we as could quick about IND and presented right. And Thank a with

Dr. Ramesh Kumar

Yes. Good question.

most companies, others including this Lily probably everyone know, have to years last is for you three target And once or As solid the all know CDK five in we one very big about And emerge or so. exciting of so. the tumors. many Pfizer, in the many, compounds believes year Novartis years, that and market, a address that new will since

driven, Our molecule other opens investigations. data that the suggests ARKX data other driven T on cell, may solid belief malignancy the B multiple is of the that gastric based inhibition and certain to door targeted tumors cancers mechanism suggesting our beyond go many biomarker and myeloma into and that

forward do in and towards and the with study, file HanX, IND including and is partner year. in Phase we we you and Phase will So Europe, an we the collaboration file well expansive further China updates will moving give types pretty the in a as as next on file U.S. IND, in our they of the this will a the of early of China expect IND, to short we details progress in X X and diversity program hope to patient

Jason McCarthy

my Thank taking Okay. very much questions. you for

Operator

comes question Joe Our with from next H.C. Pantginis Wainwright.

now is open. line Your

Joseph Pantginis

broad because X, I Hey, about size morning. process say X mind, the iterative upcoming Phase don’t guys. with potential curious can’t if the couple you, FDA with have regarding to was I the to SPA, you much study? adaptive am potential there’s any just oral the design Good if study, probably, but you if you’re of A strokes the questions sorry, so the Phase regard in and the too know any design

Dr. Steven Fruchtman

but which the preliminary have the discussed again interacted at we data already upcoming on of we the combination on the EMA be updated data, based meeting, FDA preliminary and Joe, with So have the trial. will ASH based

agreement Azacitidine. We with naïve plus be going HMA Azacitidine It’s oral And trial blinded are will what and high-risk The versus oral like. trial MDS. consist placebo have a controlled that will for the who be a patients look plus of will of an to trial placebo Rigosertib treatment endpoint endpoint The response the discussed with will that the response on based to composite size of based complete discussions will the be trial the partial recent with the on to agencies but clinical based have of on agency IWG. part and most be SPA continue of benefit, negotiation. response the

Joseph Pantginis

but early-stage Thanks, and broad regard Steve. an just obviously, but looking the then, No. in in orphans? with RASopathy. That’s know And potential helpful. of future, curious, the potential these like this because question a pediatric stroke might I for the And promising it’s benefit is a very deep these to very ultra look program, what pediatric regulatory into path patient type

Dr. Steven Fruchtman

question. great that’s Joe,

and need transplant, hydroxyurea, to have are adult Azacitidine as can also identify. allogenic desperately cell They children like that difficult these these but therapy So know and you stem to be typical of an none standard work. unfortunately try ill, the children

we So with study again in to collaboration be the JMML. like NCI Rigosertib for

size endpoint the was the of improvement of was hyperleukocytosis at reduction these They have, spleens. livers it and control And white be neoplasms patients in spleens. if the enormous myeloproliferative will a of Jakafi basically count. high you and in approved have how symptomatic look Some the

health to the also -- authorities of a improvement, one would discussed livers spleens, blood be count, control endpoints as So enormous to and the transplant. the with control approve of be of bridge the symptomatic and

relapse who For very transplanted, already is have rate children high. been the patients and unfortunately

are obviously and the children. post-transplant clinical benefit approach the authorities possible approaching to a But the to conduct the of questions, get first other pathway. of explore possibility with the for to need approval interact will Rigosertib at those an trial of be then these your for NCI we the Joe. So to ways answer health some But

Joseph Pantginis

Steve. added it. for the Got color, Thanks

Operator

Jen comes with question next Our Yale Instructions] [Operator from Laidlaw.

line Your open. now is

Yale Jen

and thanks for questions. Good the morning taking

follow-up expand a maybe bit. just Just what bit with asked Joe and a just little little

mentioned study that into also a which CR composite you of endpoints. composite proposed is sort -- and the X Phase endpoint You mentioned the OR that for fall it is PR,

endpoints? general there into of other these is any aspect composite So sort incorporated be will

Dr. Steven Fruchtman

white rate Well, secondary as be red improvement anticipate and is significant but the cells and as secondary including or there be and patients well all will function survival. working be the international the PR, as CR leukemic again marrow a secondary and of endpoint will there will cells endpoint hematological will transformation be always endpoint, response. because improvement, other per primary most leukemic endpoint are we MDS a well, including secondary thus of endpoints that plus criteria to for are there but will there that group also a CR, a time endpoints high-risk in But marrow likely will platelets, typically IWG, these be transformation,

anticipate So Phase endpoints those of will look pivotal X agency that are us want in the at to multitude trial. the we

Yale Jen

have the some might of the projection do on be based And sort you as when timeline granted? SPA

Dr. Steven Fruchtman

Well, we the days, about and by of with takes finalized. months the end -- it be full the for agency at December, is to the to three And of those XXXX. plan interactions protocol submit XX typically our the SPA end

we’ll we to quarter of that first initiate funding on XXXX anticipate based time trial. be some So able the

Yale Jen

little regarding, more for ask thoughts or one come actually And here, compound? the get other cap bit give from PK, for the development more then which in you maybe example, future and half-life better some terms handy of of detail compound to the a of itself So question regarding. Could XXXXXX, a for who investor and just us is is that us aspects,

Dr. Ramesh Kumar

all HanX. been XX some the and available developed with we they regarding Yale, be internally there up publications chemistry, PK/PD you compound collaborations share our through way and to of those can agreement about has point website. every available our be aspect, to on may or the we with The did

or when defined small obviously, drug, in as is potency delivery, compounds The are drug and but studies. X we’re ARKX. as against hoping new hit we a But that it that Phase to we ARKX, target Verzenio same remains that once are Kisqali the these concerned. all or far this briefly So target, the day, at very established as don’t and oral look portent other have you be of is molecule a nanomolar is CDKX CDKX Palbociclib

So properties. and two, ARKX activity number preclinical activity, Rb the our agent negative compound One, seen three, situations. distinguished in angle, is number single three by model in

Yale, Rb first know, that CDKX You not negative generation with the is compatible compounds.

a of Palbociclib fact, been Rb matter As resistance linked has to negative.

hopeful are we which has that are activity, superior Phase Hope can enough drug your answers in studies. be question. established X enough differentiation, that So

Yale Jen

of a That’s detail lot appreciated. am Absolutely. really and I

on again, forward updates coming progress congrats -- and So, the look to forward.

Dr. Ramesh Kumar

you. Thank

Operator

Instructions] [ph]. am from [Operator we showing a the I line Grant of no -- question have Howard further do

Your now is open. line

Unidentified Analyst

question. could rates? the be Yes. you for Hello. a X perhaps, regarding color Thank to high and comment And Phase oral what you This discontinuation upcoming was for provide, taking combo wondering I ASH. on a the appeared if poster is little at

Dr. Ramesh Kumar

you study what -- repeat coming Could particular where is to? and what data from referring you’re the

Unidentified Analyst

Yes. Yes.

data, and you ASH a upcoming I if the wondering to have this for could combo that you the X, expanded discontinuation the oral at high will it rates somewhat poster on comment Phase was On presenting appeared be

Dr. Ramesh Kumar

appropriate. probably It’s not

Diego presentation. you not are San X is press and an release oral recommend getting details or December we I session an attend you on do if more that embargo following usually abstract information. ASH you As imposes know, will complete reading with a the

able the or give in abstract So we the discuss because to rules, not you the are data data more today. embargo of

Unidentified Analyst

Okay. Thank you.

Operator

remarks. turn management questions the in further I’d closing no back queue this showing at to for time. call to I’m like

Dr. Ramesh Kumar

Rick, I participating colleagues, and the and and again and in available Thank follow-ups thank throughout for you, the analyst Thank tomorrow. today have attendees Steve, Liz. my this who update, the a do and you are day great we all day. Mark, for

Operator

your great and a program for concludes in have today’s participation you disconnect. This the Everyone thank gentlemen, conference. you and day. now may Ladies

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