ONTX - Earnings call transcript Q1 2019

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Operator

Good morning, and welcome to the Onconova Therapeutics Corporate Update and First Quarter 2019 Financial Results Conference Call. [Operator Instructions] As a reminder, this call maybe recorded. At this time, I’d like to turn the call over to Avi Oler, Vice President of Corporate Development and General Counsel at Onconova.

Avi Oler

Thank you, Operator. Good morning and welcome to Onconova's corporate update and first quarter 2019 corporate update and first quarter financial results conference call. issued and release business we XXXX first morning, results financial updates. this a with press quarter Earlier

quarter If you page highlights have Steve review you at can the not On Fruchtman, seen this it Officer that, www.onconova.com. business anticipated financial Executive our morning's first President and on company’s and the After Investor Officer call, Q&A recent the our Relations over call. will today’s discuss Steve of before make XXXX Chief website the find our Dr. XXXX. earnings progress will final Mark release, milestones will clinical and Chief then Financial and of remainder Guerin, portion remarks of review host results. some we

by in Woodman, who For Medical Officer in Dr. meetings Chief the portion be Ric the Q&A our is of today. call, Turkey we joined will

Before this during cause involve the Private to statements materially. XXXX, Act we conference statements actual differ everyone Harbor of call Securities provisions I begin, under that that can forward-looking the and uncertainties of Reform Safe include made results remind Litigation risks will which

it of in that, update Please company's With only current to in statements this future made by statements filings call Except my the factors the over information, disclaimer Onconova the or turn see the required as obligation circumstances SEC. may risk the Steve. the facts forward-looking morning and the press pleasure release and to statements as date change. issued as with they to future is speak law, any circumstances. disclaims the these Forward-looking forward-looking underlying to are and events reflect

Steve Fruchtman

Avi, and potential today's Last you the XXXX achievements and year even much, demonstrate the morning good you thank joining progress everyone. call. be significant. has again for company. more important to for Thank And so

announce X known study license refinance currency advancement terms pursuant HanX participate over development of with include Onconova a to and future fund and as of to also developmental Biopharmaceutical and XX.X make and and million in escrow a clinical following; drug also commercialize to payments rigosertib million product granted an have and will agreement, X of additional the in finished sales partners years. will while China. X a HanX HanX regulatory of upfront will advance will million China. our other two initially in. together in market. globally the next at support make developmental corporate equity in common the in our initiatives additional we payment HanX out in investment an net supply to milestone sort to legal trial with China Onconova will plan collaborate to will will stock to and that Onconova Under Chinese are sales-based aware are as premium dedicate HanX we of all indications joint China. Onconova will with highlights hope cell cancer. of as We risk these develop syndrome pleased HanX exclusive and into and the license for agreement license myelodysplastic second have In important quarter I such HanX this agreement the you in yesterday Greater China. recent to we Rigosertib First of the entered a develop rights, as solid lung HanX commercialize see we in million to the rigosertib non-squamous make tumor exchange high the Greater

we large offers look from financials, to our this value the Based on this Onconova. new anticipate opening area. forward collaboration their INSPIRE strategic population Trial to great geographical accrual robust in China. to addition pivotal In We

are as be and of to potential to Trial program the INSPIRE the been business the be the development which MDS. Rigosertib. latest development and a Shanghai completing present to look principal partner I who patients are to transaction for Experts and INSPIRE This high-risk by important in to outstanding Trial for both China and both as has chemical investigators opportunity will from has be entity Acute U.S. In China. well and this successfully May. in transformative Business addition, we at we would Leukemia MDS the end will and an meet like of attended this with will commitment the an continuing participating potential the of this to teams our Forum appreciative meeting we HanX of companies. and in at for Leukemia for with HanX their meeting, us development commend give Rigosertib conduct innovative this efforts collaborations forward the from additional Onconova

of As ON variety XXXXXX, XXXX. following in FDA program collaborative U.S. a anticipate the IND treatment for ARKX of cancers. currently of is This half we XXXX second preclinical development the a inhibitor of in agreement to and Onconova for December a submission HanX Phase X our a and in the our trial opening development of and into reminder, dual CDKX/X unique entered

randomized hypomethylating While of which Trial with to is as clinical clinical INSPIRE INSPIRE is continued we a late of clinical population Trial Phase controlled you The overall program failed know patients higher-risk progress. endpoint very business our agent. MDS programs a have on they stage survival. a been after X includes have have the This and primary active in our which remains obviously development, pivotal focus our

on worldwide. our enrolment XXX sites is patient. in than on are Trial for call, XX% of randomized more countries during requirement anticipated mentioned XXX XXX mark the and first across continents quarter trial Currently, enrollment recent the continuing passed the INSPIRE all As active we

additional We on already adding, We we our orphan designation. including have as approximately being have recently obtained sites to and expect well China sites are HanX. drug sites clinical sites have in XX collaboration based participating countries new opened where Brazil, now inside and eight with XX recently

in new reach the this with will to enrollment Our XXXX.We goal in trial INSPIRE addition populations help to of regions new that on us second large and to in goal. be these continues U.S. half the the complete the believe regions sites

our are remained of see, can With progressive. MDS, you with the will timely oral patients INSPIRE and As high-risk profile. a promising programs reported with rigosertib safety we previously manageable our Trial focused respect its in on and combination full in II we study Phase which efficacy azacitidine other dose completion. to I mention laser

will Administration. new Phase the be is form are We of the to results this in presenting currently the combination the in trial Congress at under trial June Hematology Amsterdam. from review of basis expected and Drug U.S. which Association the a pivotal Annual Food data with XXthEuropean The II

or therapy of will for normal composite U.S. count azacitidine we trial endpoint determined are with adult first-line rigosertib numbers of combination thus the and assessment the which higher-risk on remission and imply oral complete blood that Regarding be request FDA the will and patients Phase III be political overall an treatment our endpoints SPA to based complete IWG normal special response primary of for criteria. blood of partial MDS, these the response a a remission elements. Both a endpoint circulating of

We FDA II our meeting have of Phase end the the completed and are discussions ongoing. with

typically first-in-class partnerships filing azacitidine in forward of the second tumors Phase for over of I cancer cell rigosertib the Following been with has CDKX/Xwith breast ON in resistance III which submission, IND preclinical receptor-positive ON In an metastatic trial shown oral SPA mentioned in and XXXXXX are finalization within [indiscernible] look effective studies anticipate available be inhibitor dual hormone following opening to ARKX. to early expressed very breast to half clinic and as as activity CDKX/X as CDKX/X XXXXXX, additional with XXXX we combination lines is used women the We a in and commercially which inhibitor. the inhibitors, against cancer for funding. combination of

HanX. lung us our trial in we our Based and rigosertib mutated cancer cell RAS our ON in will working combination Japan corporate immuno-oncology conduct I potential partners, of in that in and Pharmaceuticals, many proteins remain addition in that noted, is indications cell the trial confident in Phase a trial with experts As initiate of Together is we pounded tumors. the Japan. within XXXXXX already believe this in commercialization is U.S. as XXXX. has agent KRAS to solid many that on and rigosertib effects, new partner also Korea RAS-mutated non-small Concurrent cancer we the a cancer Phase non-small SymBio rigosertib lung lung rigosertib I RAS with for mutated with target to MDS with

for in the Forum Association which Upcoming and California. We Cancer The will rigosertib and you in at Hematology the Research worldwide. pertaining continue Association Copenhagen hope Newport, participate Meeting. Acute conferences and and made at present to the actively Amsterdam. will Leukemia I at MDS in oncology Congress in major European Annual follow XXXX Acute information We Leukemia Forum be recently presented American the trials completed symposium MDS clinical hematology recently to China presentations,

dose conducting upcoming be Oncology Jakarta. therapy in also the and RASopathies respect XXXX and of rigosertib for Society Institute time. pediatric other Annual single in the attending for pharmacokinetic will this is escalation with National dosing with We June American patients first studies last germ line models programs, cancer pediatric Clinical possible in development pharmacodynamic of Cancer agent preclinical Meeting mutations the to With the

Lymphoma being of a JMML. University study excellence Society. driven last studies the studies continue in JMML, recognized In California Francisco, Leukemia leukemia of in Leukemia addition, by at center funded rigosertib preclinical the & Myelomonocytic a San again Juvenile preclinical is at of for or This

of a Cell have investigator produces studies and blood Centers for study expertise Excellence in include disease. the too conducted initiated this numerous with on Squamous Carcinoma circulating many Europe initiated rare investigator myeloproliferative at skin which bone will RAS in studies driven which patients also We have that the rare the in of marrow Other be U.S. study a neoplasms, including ongoing cells.

turn franchises a Officer a for focus of existing new our Rigosertib, partnerships With that, to results potential to the has colleague chemical programs within I Financial single new As entity. Chief our the XXXX. you would the rigosertib potential our Mr. for believe like can and multiple also over call earlier to quarter looking pipeline. first enhance Guerin, resulted of financial for my robust discussion the through see, advancing in Mark has stage a collaborations we Mark? on while and

Mark Guerin

March expect for we projections $XX.X to and with from sufficient million XX, upfront that transaction, XXXX ongoing in XXXX first into period $X.X first early the as HanX the $X.X our receipt cash March of General quarter XXXX XXXX.Based first comparable current and was million the Thanks compared good $X.X Research $X.X on the quarter. development funds be our and for operations and Net quarter March XXXX million Steve XX, morning, loss $XX everyone. for million comparable ended XXXX. fund of the equivalents for and and ended to Cash million will were million totaled trials $X.X for XXXX. cash compared XXXX expenses and million as XX, XX, XX, expenses the March administrative comparable ended in XXXX. for with of March $X.X the period quarter million the were

workforce which We during savings year-end a XXXX annual ongoing $X.X back $XXX,XXX Also savings severance reduce completes to to of at in net the This focus approximately as our costs we Steve? of call in of INSPIRE financial Steve. now turn million. noted continue our first an a on of resources review. represents the look reduction I'll our approximately my cash and executed to XXXX to grants ways our XXXX study. call, the quarter in

Steve Fruchtman

Thank Mark. you,

momentum about in continues We the we're making are the pipeline progress very and both business and to build. excited development

on MDS for XXXX. operating in value trials, commercialize these since to we INSPIRE our entertain. [indiscernible] first to attention. and are for successful was all all in please the any presenting FDA expect for we questions for we’ll If your to Thank Our NDA is complete to approved via team shareholders be to the call Operator, which build the by data our process. high-risk cylinders new Trial the open you the happy therapy

Operator

Wainwright. [Operator Instructions] with And Joseph first Dr. from our comes Pantginis question H.C.

line now open. Your is

Joseph Pantginis

regarding can more Guys the impacted or is, you the you all? the to little are SPA. logistical discussion that I us can so what shutdown think my questions government color mostly the questions And provide one as a outstanding first at are remind points

Steve Fruchtman

I’ll Dr. question. that to Yes, ask Ric? Woodman to respond

Ric Woodman

Thank you, Steve.

adjustment dose FDA. think I to dose we with finalize outstanding the most question related have and the is to starting that

the agreement Our statistical FDA. much patient very population assumptions, were things generally with our in both

once. all from of answer, the get terms I us review that ex government one at rolling all number did typically you SPA have the feedback to particular strength that shutdown questions you and get think is questions would in that with impact happens would we the way the FDA, what in an a as the opportunity of

dealing we're to obviously with and so continue we finalize to all in FDA. And responses that time same the our

Joseph Pantginis

it with can manage have with Phase some EHA curious responses these the I to and what patients going evolved guess is over expectations just we II to regard update. to regard about oral of upcoming follow-up longer-term how might just then the And you see, be might time?

Steve Fruchtman

in Phase study on with update an of remaining continuing rigosertib with to combination XX-XX The patients azacitidine II primarily study. the will follow we're few be

haven't analysis across As we various as that at previously be subsets, what well similar to as but response the shared additional the IPSS-R speaking at looked generally ASH. efficacy will very we such

Joseph Pantginis

or Mark, get to some with X last for baseline discuss can upfront the a of first so then run-rate million. And in regarding one-times going the regard a HanX restructuring my sense color to you the more then maybe I think trying payment just maybe And G&A question new and accounting quarter first you the maybe the from forward I know the G&A? had secondly, from for little the just

Mark Guerin

recognized of stock would the in would to million the some and million X way through larger term the there our depending of on have is factors that, agreement. be milestone to if of the fully premium number some that the deal the we recognition as So immediately could it revenue. analysis some the transaction be for probably revenue And of similar for likely recognized it that then they revenue go then but of the a will are be a first question, chunk past, not the be of through the yet over we X paid HanX upfront for yet

burn cash some so. the per first that mentioned. expenses would been I has specifically for hopefully previously it So ongoing now. in that be the expect answers you're is one-time second Then to your quarter continue have reduction question, we will or enforcement question million quarter our your in did the which And right rate what I X.X

Operator

And our Dr. with next McCarthy Jason question comes Maxim. from

Your line open. now is

Naureen Quibria

on This Naureen is is some for I there noise. if apologize Jason. background

is question regards CDK So with your first my to inhibitor program.

that about focused trial Now the little you bit cancer in might moving in other will design selection solid tumors? you breast and particular can an that be to IND or the a patient closer have just you’re talk trial it

Steve Fruchtman

that So thank one I’ll take Naureen. and you much very

in eager I all because common, will IND play establish the receptor-positive when common ARKX CDKX/X the tumor the dose FDA Our appropriate we’re clinical Clearly, I man. plan role. we eager where cancer. solid understand that to when metastatic in to this the we submit all unique Phase and the hormone a trial inhibitor be we’re is a breast say will And metastatic ultimately trial

already be commercially indication like that diseases myeloma, because by study deal women fail because these the site more response you Palbociclib, a addition . failed So who XXX us we we'd ARKX a having ultimately in saw Phase addition a patients to that but of of like approved would are women is to for multiple CDKX/X clearly where in who commerce mutations of But many with carcinoma be which I driven one would be the trials big at a in study. also are the inhibitor seen to I in unfortunate we can that ON interest let's these understand in planocellular to if like say Phase will

Naureen Quibria

you just your was as your this of for response follow the presented that you in part and potential CXCXXX is one I strategy SPA rigosertib. bit curious biomarker data you And a is package something patient of little something at review? or continuing wondering biomarker included trials the I to of as pivoting any that are regarding just for to was the a to that ASH

Steve Fruchtman

a So we abnormalities broad genomics and number continue all to other of our studies. study in of

the a right to best much trial on now deep referring will MDS decisions one than going make INSPIRE on forward broad believe sequencing patients it’s biomarkers. on these a all larger for and identify and population doing instance that to you're of So be the genomic Trial the how we’ll we based

genomic already the those patients the run and to but on be They've So we’re will call randomization batch the at them specimens deep repeat been all survival to Trial waiting having INSPIRE Trial. the post sequencing. INSPIRE on randomization ultimately

Naureen Quibria

And oral Forum patients. Acute patient had the we recently one of initiate last plans a California II rigo were the XX study was with small Are though to Leukemia any from and pretty under there just AML response question indication? that impressive XX% me, in study patient in number Phase Azacitidine the the responses

Steve Fruchtman

Ric? So take I’ll attended to that who let conference question. Dr. that Woodman

Ric Woodman

Newport plan Acute Steve. study we They Yes that We who that's who represented other responses a Clearly, studies the Thank and in patients. have patients have that Leukemia very Phase outcome. at subset were patients MDS patients from heavily pretreated we to with in elevated that of small population in prognostic saw Forum counts. data of the the presented addition explore were to XX-XX. a poor blast part further you, AML has a we I/II in

our blast We're other parts the and we to define summer a having over that define United patients larger an patients who pursuing. and world would the the is counts. is how do have much blast world in have defined elevated potentially above going of as back to of AML. XX% clearly that the do We interest initial acute patients States. it leukemia the counts. studies blast is in myeloid the we’ll So is of around in counts how because worthwhile counts responses varies in learning with in XX% including Europe. elevated have based oral it's in is It is other some related world we on go subset them analysis how blast the to retrospective Above Part fluctuations they have who define hope generally have agent the

be so about that first based And proceed either oral both information blast. in in development on IV will we decision understanding step. we’ll XX% AML of rigosertib you. and by the rigosertib patients response how And with defined clearly a make or as further these our XX% Thank setting then can

Naureen Quibria

that in Actually clarify to KRAS to lung Could would cancer going guess are coordination they question. that little regards cell last separate or clarification be I have with to Thank two are IST your I to This regards partner studies plan you. working little non-small study a on you the pursue. one be with Japan positive, do in final helpful? you they

Steve Fruchtman

at we study be initiate the patients So you lung would pointed medical out alternative in with KRAS be the cancer of will plan drug. the and progressed on combination to a mutated U.S. immuno-oncology. who is already major for Tentatively immuno-oncology study center an that as study a

be could how be approaches lot we We SymBio focus studies also again to with it get have rigosertib cancer we this sites actually we cell a on non-small this that there interest mutated many those finalized trial but commercially we're IO the cancer. in plan the approved is to the mutated free to optimize see major lung to INSPIRE rigosertib of be combine ability attempt a collaboration a to best a In variety U.S. of the that the do yet we can in will to want combine of continue KRAS the in the negotiation our the research not program SymBio with how And will to we’re to very program working though other U.S. everybody to complete do, with lung I trials KRAS Trial. with excited have even and remind for focus about

Operator

Demir Markets. from Our next question comes Ahu Noble Capital Dr. with

open. now is line Your

Ahu Demir

color the study. at first the patient partnership question III present progression on for the or like for wait what XX patient you be know we do a patient ASCO PTP that from you biomarker. expect Congratulations rigosertib the population? on Phase when clinical My EHA, expect I will do expect data population larger do we Can and on you the will more we made. and little of a just do larger perhaps potential we give as ASH or data bit using for mutation

Steve Fruchtman

Ric?

Ric Woodman

and of two the we be move and use terms mentioned is Well, then it to profiling in moment to biomarkers continuing genomic of of that at rigosertib available preliminary so XXXX study probably see areas these at validation will initial of focus other and genomic one will finally in some program. studies that what with I be data profiling IV information the look looking will and Establishing INSPIRE AML XX-XX, of studies of the biomarkers. take than in look then oral type ago a is wait would the in some going into at we probably that's terms something and and

Ahu Demir

the half on be cancer Could and be the correct? what the of explain My breast on CDKX up later follow Naureen can XXXX indications, on program that following will IND be and on also first question will question. is you that’s mentioned. the it first will permission other you filling think I

Steve Fruchtman

would site with inhibitor. It’s who IND sorry will number you. establish this we I if trial, trial clearly will June, hormone therapies cancer like at trial of to the a question them, submit combo the metastatic we a in-person a is fails your no receptor CDKX/X commercially breast to so we of our so to patients combo we have the where dose oral which Yes, plan opposite. but in positive available be going end of be patients but already other first to to alternative part your for hopefully confused identified, oral am be to by available – I large of we’ve first

where ultimately would optimal So diseases oral we trial groups to the to of of also we also are want know but dose Phase going we I these areas get identify to in like already that it’s in be certain a patients, to combo study.

CDKX/X oral of for certain inhibitor. refractory combos with cancer like towards a metastatic a the be breast combination will indications it So bias commercially who to available both patients current failed

Operator

Laidlaw from our Instructions] next [Operator And with Yale Dr. Jen Company. comes & question

now is Your open. line

Yale Jen

or only potentially added deals also rigosertib, well? HanX that the IV version for terms as the that [OROX] the include would is In

Avi Oler

to formulations. rigosertib hear whole. you speaking. is This includes Nice from a Yale. Yes, it includes It as Avi both

Yale Jen

definition the moving that in have if major be for suggesting be combination first-line turned floor forward? sources And partnership could start you you HanX of depending this will the SPA maybe and on Okay. prepared therapies, the or would remarks resources the the that one suggesting the

Steve Fruchtman

Yale So combination open in for reality that question. also tremendous thank first-line would to that important Japan. in is we you, there interested in The is, is interest SymBio clearly participating high-risk in trial and HanX very that the global like trial as is

goal addition So value to include plan. of in and next with our include based in site on that new will and start number HanX partnership sites a our the this so China also a Japan, in U.S. a be is in funding to to site with include of to

Yale Jen

that population mainly countries large clear, their companies study supporting that the respective be so in U.S. support to me means study with not those - only but be for the let there patient U.S. both so So study the would is coverage? in

Steve Fruchtman

That is correct, Yale.

auspices responsible trial countries. be under be participating will trial funding but be respective we their So in will will they the same our we the in

Yale Jen

pathway surface more at AMG-X, another one irregular We there’s there of focus just probably question for And data come Amgen. that understood readout are called XX KRAS you the ASCO. sort some that starting have KRAS that and

particular think that have a comments program as do you target what above that RAS guys stay about partly? and any You

Steve Fruchtman

ASCO. data the at The is to forward comment Yale look seeing we

Operator

I further any call over the closing would for turn no showing questions. to like back to remarks. And time Steve at I this am

Steve Fruchtman

Thank you.

look So achieving enhancing our to X year, forward XXXX of including trial completion intravenous well continues milestones advance rigosertib. value Phase this in we INSPIRE enrollment and to of

first-line II pivotal geographical with combination and Phase all in towards MDS III is the our a also as well pipeline. patients partnering execute Phase agreements including trial we're continuing our for in advancing rigosertib licensing azacitidine to program with Our high-risk strategy, additional

late-stage scientific forward at continuing pipeline. look position data clinical remain continuing high-quality we presenting and we our to we strengthened our present today. and that to our also publishing scientific advanced key and conferences programs, for multiple opportunities by cash scientific achieve journals optimistic business medical rigor With and outlined clinical you with the We that in our milestones will development and to

support. call may us bringing As tremendously We have participation Operator? again. forward you always, look your to Please questions. and your thank appreciate and with free today's to to for with Thank you MDS. the feel you any for help of additional we contact continued your high-risk excellent on patients questions rigosertib

Operator

participation This gentlemen, thank does you conference. and for today’s the program. Ladies your in conclude

You may day. disconnect. now Everyone good have a

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