ONTX - Earnings call transcript Q4 2017

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Operator

Good morning, and welcome to Onconova’s Full Year 2017 Earnings Call and Webcast. At this time, all participants have been placed on listen-only mode. At the end of the prepared statements, participants will have the opportunity to ask questions. [Operator Instructions]. Please note that the remarks today will include forward-looking statements and that actual results could differ materially from those projected or implied in our forward-looking statements.

note important refer could statements you press and of to actual in description in release we statements differ, to the a factors SEC cause that results today’s the For company’s forward-looking filings. on the forward-looking my now the turn and to Onconova’s call Dr. pleasure to CEO is It over President, Ramesh Kumar. Dr. proceed. please Kumar,

Ramesh Kumar

Caja. you, call. welcome and full our Thank to morning Good results year XXXX

turning this and management in a me our XXXX in culminating few is promising trial. continuation development the Onconova’s clinical clinical our point results the of interim Guerin. team Phase the from year INSPIRE months of of Joining Mark CFO, first pivotal the X announcement of and marked rigosertib the lead candidate

we with address of seek medical needs We risk higher unmet to frontline proud are be as at the patients to the MDS. indication of this

made We advances pipeline rest and development of several the our across objectives. strategic business have met also significant

regional December, view the treatment in inhibitor dual rigosertib ARKX. this of signed licensing this to + with an our hematology/oncology now for pipeline We we wide secured Biopharmaceuticals collaboration have and portfolio for also XXXXXX, as rigosertib and a in Back MDS. agreement a first-in-class agreement Early of commercialize with further regional agreement China has Latin the HanX America. a candidates. license an We region. in Pint announced existing ON agreements Pint we footprint validation week, for of Pharma CDKX/X

places XXXX. collaboration ON an track in this Importantly, data on towards IND and XXXXXX clinical

National laboratory clinical combined to NCI conduct these capital we entered associated with execution Research multiple of call, Development into with underscores assets Institute. we programs. in ability pipeline the late-stage in a will RASopathies. pediatric our finance cancer quarter three the Cooperative third trial preclinical leverage on and to studies results including As CRADA, Agreement recent rigosertib program research raises The transactions and foreshadowed our Cancer

across trial, positive mechanism of ASH our months. recent action of highlighting also We the rigosertib MDS In presentations at we delivered the analysis results in MDS addition promising and interim December. two the reported in in INSPIRE to pipeline activity meeting annual drug

continued additional from progress stable in with also a rigosertib MDS regional lived oral Based X creative IV We to program one median with MDS, trial or non-responders. patients response showing longer partnerships of oral rigosertib. the expect study our to develop the X rigosertib/azacitidine and frontline to advance results of disease Phase collaborations combination that in help on pivotal we than Phase X/X published Phase for patients a in year

ahead, plan Scientific Bone data to clinical Maryland. the present Looking we at Marrow Symposium Disease Failure in

execute ever the scheduled HMA studying been therapy. that We area failure following with There higher no the the Plan after MDS with choices is moving Executive very the in of and meeting and trial. HMA to the Monitoring of the the of to patients X will also patients The on, the unmet has most authorities Committee previously expanded recommendation the January, expansion approval is hypomethylating in now and at interim eligible abstracts for our need. discussed Phase frontline relapsed FDA and or recommended progress continue tremendous we we using XXX trial by HMA. new This patients All-in-all, most DMC in that target or a prior current failed this are after is of patients These the trial MDS We’re these I’m forward to risk of recent trial risk medical The Statistical EMA. trial. advanced well Phase key are which for is after present have now size sample INSPIRE with pre-planned we Committee of the INSPIRE XXXX. a with aim progressed Data in and agents approved consistent of a the positioned unanimous our National In in with pivotal analysis INSPIRE have announced short increasing therapeutic program advanced there agents trial study overseeing X patients are respond Society who focus. enrollment to American our therapy the the of by enrollment re-estimation, the for I is lifespan power failure based MDS patients, will enroll delighted with with few believe Chemical the Orleans. study rigosertib one-time and New on our two design which months strategy IV for highlight higher the health second-line to therapy patients. on Analysis outcome

interim the than remain In population sites the constitute four continents, ONTIME countries the patients risk of blinded across overall of XX of using As that expanded both continuation the only expansion the the a pre-defined patients study high the the following for INSPIRE options analysis Accordingly, based than size for subgroup greater IPSS INSPIRE INSPIRE high required elected was for re-estimation, past, for the of review the study. in XXX the on based the results. proportion than interim, as half and observed active of the mentioned trial data classified SAP much more on design high for risk than so interim and featured subgroup the pre-defined option very an the patients is the analysis system. very by treatment included was planned, the but as survival. Revised in continuation pre-planned trial in will limited adaptive trial After risk been INSPIRE enrolled, have the more DMC. the in trial It’s permitting patients primary of enrolled. XX% enrollment endpoint in the several analyze trial third very trial discontinuation of higher and far, note important trial to trial we study that the sample through futility, which ITT

We’re completing the to prior achieved be overall planning HMA enrollment We with including MDS partner Latin to the first in for analyze and can believe Europe our conjunction new who We therapy. failed to look survival enrollment half XXXX. full patients the in that America have and add forward sites territories Pint. in in opportunity of

with XX Our improve further the globally to of to patients. financing mechanism resistance additional second advanced this therapy X Once combination as indicates with outcomes rigosertib of is than and protocol Special oral of patients azacitidine plus the conducted demonstrates pivotal Phase month reversal Assessment. therapies. and resistance with higher rigosertib MDS. clinical in in trial AACR plan may to The Phase of A to is X expansion that development we at be HMA rigosertib novel the combination Special the with business transactions. and/or is MDS epigenetic strategies fully that Earlier warranted. a treatment program evaluated, requires The planned initiation also process, Phase of in study more which the AML to relating of potential is first-in-line Conference. combination overcome Previously with submit of is results action risk patients Protocol combination to X presented enrolled data the an expansion month, this for expected be the the trial presented azacitidine we therapy suggested the FDA data addition under higher potential SPA trial to the risk

many Given future. that it go AML, our study patients to AML XX% as the as intention MDS on develop of to is in

combination conferences at data to present in and this initial also selection scientific and regimen, for dose of MDS result study of potential from We the combination throughout AML. optimization expanded the highlighting the plan XXXX therapy and

collaborations. in This to announced Pint market. existing shares to was and European-based rigosertib adds agreement most by recent with transactions treatments make American Latin totaling pharmaceutical with of advancement the exchange America. the investment of focused at registration will rights, programs Our plan million with of and In a Pint Pharma, is Korea. deal our in commercialization is deal for strategic these America Japan company couple to on purchasing SymBio Latin to X.X our premium commercialization development, The in Latin and and for up our partnership a

to In in tiered agreement. up milestone sales included the royalties of net on addition, are payments double and XX.XX million regulatory, development digit and Onconova to sales-based

CDKX/X advanced has payment, and royalties enabling registration a CDK XXXXXX inhibitors. believe to regulatory In we provide We will for that territories in for pre-clinical XXXXXX of We in HanX territory. + the for look licensed also global is Chinese funding of enabling region. development current their with their in the overcome agreement an further are limitations to while initiatives the to with Under oral in in ARKX, generation first-in-class which trial December, Pharma and development. currently is in inhibitor potential terms with the clinical compound sale the due trials HanX, the the of the dual X/X some of of the is signed strong agreement the of important Pint receive potential the upfront rigosertib as commercial The will studies ON required Biopharmaceuticals the finished we and commercialization collaboration expertise outside a which IND and China. We license experts commercialization working has supply HanX advance milestone on our and studies. at payments, maintain we oversee companies IND Pint for as centers product of will rights Both IV and well clinical drug ON China. and development, will will forward sales. feature key in support clinicians collaboration to

to timeline in for months. for process expect and a coming have We clinical initiated XXXXXX pre-IND a the FDA the announce the with the and IND ON exploration plan

require the of generation use. generation the potential limitations next Our a compound therapeutic current the some combination has overcome treatment compounds to of that CDK for

high XX% to agent XX% of a call, is and ASH and two XX transfusion highlight Notably, mechanism combination MDS endpoint. activity of oral of could data of also As towards X a new very dosing, molecular in optimal drug basis approval which excited with incidence during potential XXth advance demonstrating lower the receiving presented of rigosertib achieved of where the this the the last long. we MDS; activity an patients Meeting and was in on rigosertib evaluable duration MDS Phase as our is The such, IND. treatment presentations Atlanta. Since therapy be we risk patients, in lower azacitidine. an data trial we’re include rigosertib Annual second earnings And risk in of highlighting independence action quite presentation the XXXXXX for and the the delivered

or phase also reduced blood stable stabilized or disease We study bone Leukemia publication rigosertib response MDS of patients survival with Research. than peripheral improved a results year progressing study, blasts in MDS one marrow to of a rigosertib non-responders. and and longer had journal X/X AML from the announced in patients In counts, with and

a in going on rigosertib lot So with MDS.

by encouraged in are late-stage financial year. in our and We developments now a I call the partnerships. and earlier the of for results Mark? discussion the program the Mark progress our will over Guerin, to turn stage exciting CFO, full in programs our our underway

Mark Guerin

to of XXXX. the the XX.X cash compared loss Ramesh X,XXX,XXX XXXX for we the XXXX, $XX.X Net Onconova’s A lack year-end included for was convertible XX, aggregate of At million of in of million approximately on November expenses the at $XX change to administrative for ended stock compared in in underwriter’s period. year, of the This option year, preferred million February closing full for proceeds full now the to to underwritten XXXX, a $X an end I remarks. shares the development for warrant X.X million offering his and compared million expenses fair XX.X exercise Ramesh. common XXXX, shares revenue million million in XXXX. totaled for the and and to to Prior General for year-end of due compared million. a liability equivalents stock. announced hand XX, the Thanks, XXXX of purchase X.XX year to collaboration offering value XXX,XXX and the XX.X of in XX.X to million cash X.X warrants Subsequent and year December to million purchase XXXX XXXX the were period primarily XXXX. smaller public December prior the sharing the of securities. an Series back XX, closing Research gross of additional will cost call were XX, to on we announced

Ramesh Kumar

Thanks, Mark.

National the Meeting. collaborators at highlighting two coming we in plan clinical Society will abstracts Chemical additional ahead, this our months. Looking to present data Later development present the American Sinai month, from company’s Mount School progress the scientists, of the Medicine, of the and

The relates the of during abstract first storage. to analysis clinical the product stability of

new pre-clinical AML. X which pathways, Src The ON inhibitor XXXXXX, type second therapy to for believed FLTX of novel is important a and targeted stage be relapsed of refractory abstract describes chemical and entity

am at and remain the catalysts impact for in Failure a minimizing setting present committed I dose additional late-stage results abstract our Symposium the Thereafter, exploration of urinary the like MDS encouraged preclinical XXXX. risk Disease by the we questions. to would promising higher the across will focusing which I stage call We now the an on in the including progress in to study Marrow of Scientific of unmet events, Bone medical incidence risk-mitigation needs MDS. strategies patients hematuria. is in to open serving trials, on

Operator

Instructions]. [Operator you. Thank

line Joe from comes H.C. the question of Pantginis from first Wainwright. Our

Your is line open. now

Joe Pantginis

interim taking from the a [ph] How from standpoint. the Ramesh, wanted for or Thanks much the has not about PB talk a interim impacted bit your to Hi, impacted question. PB guys. the discussions? specifically visibility analysis little Good but I morning.

Ramesh Kumar

good of us, Thank the flirting difference deal say analysis with the has the all talking point A interim as for them. the Obviously us, to A lot have companies the but in movies. see Joe. none make been say you, inflexion they interim hit very would made was analysis and kind a It question. of people of would I wall. the the

you Pint surprised but interim So the is really Without announce for the America. second America, dialogue which including signal that that provided a been large Latin forecast need not by and to substantially third were Latin on collaboration, some have a a we for and including all there made the America us. and go that partners very, launched in I’m positive Latin is analysis It’s line the It’s relieved medical interim in example, Monday and trial the of aware delighted are thriving And we in potential very and regional the giving and Many to, were of not course large collaboration for promising difference. analysis in is informs Pint territories. we the to drugs, meaningful a we are a pudding that allowed market. market people were proof details successfully. having ponatinib

So, Joe, my interim analysis a was turning point for in mind us.

Joe Pantginis

just royalties, and/or one to the Thank do get very if you. logistical make question. helpful. want with and That’s milestones follow to with And quick I you potential sure just beyond could regard fee a I also collaboration for others up Pint supply rigosertib?

Ramesh Kumar

Yes.

we As with manufacturing to you XXXX, a know, our existing collaboration them. with fortunate SymBio, the were supply agreement them. sell which sign to and has We in drug

So the they lot over period selling clinical done X our INSPIRE partner was and we the look numerous studies time, trial the if Phase our of participating at to of they and product reported financials revenues are in Japan. a now in you have drug

supply at future. small the a profit of can agreements to ability significant going is before be drug our be once to but commercialization, quite drug to part supply us. is even to the the So And commercialized, then helpful them

Joe Pantginis

the Thanks Great. for clarification.

Operator

line from Laidlaw Our comes the Jen from of & next Company. question Yale

Your open. is line now

Yale Jen

the Good morning questions. taking and thanks for

of are aza, study the of the oral for? forward iterate could what in a looking more terms color design MDS plus drug or give the In first-line we the going reporting, maybe little you what just sort and rigosertib

Ramesh Kumar

Yale. Thank you,

we drug the will long. really that knowing is frontline to to multiple years. on there think going very the be money opportunity very, us. a I indication we That’s is want duration the indication for Hopefully, market treatment go big careful the patients of and be that in for be

The fine EMA the be the schedule the really also discussed before really, been already the So and start design. dose FDA. design has the trial. sure the design. we with with we to They’re trial of need approved has

the So survival most three features is the is The difference. of is are there the Big overall endpoint endpoint. and One design. that important not response.

years, who take live going the many So normally in if patients survival years. to we multiple trial is survival-based do many, have to

are completing a use within when data get can overall and response, concurrently can top of pretty line year much you you get So being as data trial. you the enrolled patients

that’s are in and a which placebo Number of with have a placebo-controlled, that FDA azacitidine agreed can we comparing plus rigosertib. we two, difference. study So standard azacitidine care of standard EMA do with big care randomized oral

the confirmed So has by been the agencies. design

third The factor and who most that study important the be are is frontline population eligible patients for will therapy.

So going on label to large number label our be our in multiple to which going be a if is of similar to is very and approved, are for if you’re successful expansive the way years. a azacitidine for which patients the who a trial pretty label is drug is

very, So the to have that if going on the approved go, very trial FDA, INSPIRE based and trial, trial trial will the and to trial, quickly, because the an drug. ready SPA get we we In an drug. care, physician’s enroll active an and choice unlike all supportive best by based factors control approved not have these designed patients the active on is the get the patients INSPIRE, and we believe in in the

So in combo all patients trial, azacitidine one. the get in world new is available. the And we where can an the two, drug, number will active everywhere the trial do number

For go doing already oral markets. Japan an because trial those other and U.S. and like are Eastern to of and is and trial we China can Europe the can it’s and do countries we standard example, also in in Latin but care drug INSPIRE European many the America azacitidine we

other trials an with response So footprint patients a faster randomization can go this getting as than geographic go. and analysis, of the all finally short bigger makes combination line a one-to-one the active much top trial

of the start this of forward to SPA would the So process, the be and approval trial. announcing we CTA looking

this make additional to trial ability in think progress concert collaboration our I mentioned with additional that to As licensing agreements. will you, we and

Yale Jen

So that of this we be SPA year? the or a something in half for of second anticipate could or possible next should part maybe announcement process year later

Ramesh Kumar

I results SPA because announcement think will starting the start of data trial the the trial. requires. SPA the process that of expanded require And from the to show this the process month we’re happen as and earliest doesn’t the funding

and our So as quarter that to process the half. And us sync SPA and we start which the know, hopefully you’re and allows takes months several with you will SPA earn [ph]. that, be process release once finance data activity to then is second And right. trial. then in The have business development third

Yale Jen

helpful. Thanks a housekeeping question great. Okay, a for lot. That’s just maybe And one Mark.

Just your based on the the the Would that reasonable you XX as little as pro have reported around financing cash and a in well that my forma recent estimate base a is be cash probably PB, guess? million. bit that

Mark Guerin

we said we then financing cash current our the third ended we on the think of and And quarter the the Pint with year we in that deal. – So you we and announced balances, into have XXXX. get and 'XX burn to from our cash press I release based our if four expect

Yale Jen

helpful. Okay, a appreciate very I great. it. thanks That’s Again, lot.

Operator

Instructions]. [Operator

McCarthy comes Jason question Maxim line now Group. the from next from Our open. line of Sir, your is

Jason McCarthy

Hi, guys.

you’re give one know that what down I runway? around to just questions from question, taking to the payments going is burn reduce that But color like little the is of answered. look levels I partnerships, measures can of the and rate think runway? I the what on extend discussion there for somewhat can piggybacking hoping do those saving might bit a regional to a kind the me And you you historical burn upfront Maybe bit more what granularity give could extend steps earlier been little cost potential Joe’s million. additional forward? on more me of some some has about X my that expected

Ramesh Kumar

morning wake Jason, thank same up question, That’s you every so that’s much. asking the so we paramount.

deal are really quarter of some X.X really start we As 'XX, with variation the can what we in had unless you upfront, we nice cut of big report we decided period that quarterly expenditures. about the And we know, expending burn we’ve that per million is make quarter. a in over of back since to on longer first INSPIRE but have times

guiding get but hard money spend are below it’s And X more easier if certainly what very money is more be So comes expenses we’re very working we in, that a to disciplined. have we to our to million quarter.

So my deals? personal that’s can My offset do can number what we That’s in the funding just come these offsetting answer burn by Number could our can goal it one that two funding things. of really rate. is regional or expenses getting is be the are two, the number the – money one. shares absolutely. job non-dilutive then upfront could could non-dilutive we how more partner cost And And it in development One, ways. company. really important be to

Another to just INSPIRE remind last is be that we is year can way trial of Phase the burn the undertaken everybody, running late-stage paying their two doing we remember share were that downwards to the the Japan. X globally. trials; important patients think trial, patients SymBio rate they’ve the trended And enroll which for – in partner XX% of is our

for they pay the they drug, So buy it.

offset. that’s responsible. we rest the of are world, an And the So for

money costs trial had were So the only to we Phase U.S. And we advanced important trial sake but combination. Europe. X in do the the are we on for of going also of in controlling the do decided Phase and doing trial to the trial were Initially, we X U.S. expansion that expending

measure. that cost another So was containment

trend Phase with we year, burn X going to So fact with the month. enrollment announced, oral I be further be we combined that are are rigosertib the on this beyond doing as down. Phase more work No the X trial have expansion That going the trial. rate SPA done until any we and will this clinical to the not

big needs our and stage to try all In INSPIRE; we to three do quickly another things; startup financing are close Phase offset be we focus if number a of as to and our will spite three, can one, get goal. mind very top advanced our number as close we very as that, again, on data trial. two, X a of deal line the company, of to budget; So very

question Jason, So, in and you proof for the is the thank that pudding.

we As on our in repeatedly would we to plan. are can things the implement basis, that and execute these like meet you to quarterly we prove with and that you

Jason McCarthy

very you Thank much.

Operator

call seeing further to I no for would Kumar like remarks. am Dr. questions. back the further any now turn Ramesh I currently to

Ramesh Kumar

Thank you questions you. attention this Thank for the for your and presentation. longish

a to how may are we your the juggle And call things today. are many trying how to meet reflection and available we Thank which enjoy you and we Just of trying with of the are things and to advance. many are answer rest in you addressed have any not you day. questions

Operator

have and great gentlemen, you today’s for conference. Ladies you thank program concludes all Everyone, in today’s and may disconnect. day. participating This a

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