ONTX - Earnings call transcript Q3 2017

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Operator

Good morning, and welcome to Onconova’s Third Quarter 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.

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

Ramesh Kumar

Thank you, Caja. quarter Good morning, and welcome call. XXXX to result our third

Joining CFO, is management me Guerin. our from Onconova’s Mark team

in with made also quarter, Phase milestones program inspired analysis for of risk of first encouraged preplanned coming by key and lead high III patients position to a now solid This a myelodysplastic headway special our the recent can and year. for have lot making in also global increase progress enrollment this IV or we're We're are assessment for the the in and addressing months. programs anticipated be in We're designed achieved process a for enrollment suggestfull interim syndromes is trial the trial initiate our in combination trial, azacitidine of protocol rigosertib clinical with adaptive next approaching XXXX. of now needs patients MDS early half A this we MDS. rigosertib the

for Our advancing new and held we developments month to leader as pediatric New key preclinical opinion for patients is last a breakfast discuss planned in program RASopathies York RASopathies.

the have third quarter multiple low-risk and outlook. XXXX we presentation the independence the in all, with progress All meeting, two ahead, I'm transfusion poster in MDS demonstrating long-term Looking years. ASH out at in going very pleased

an trial. extending trying products. detail Where the rigosertib therapy This inspired I'm reviewed both analysis their to or to life agents the In based And the or and addition, SAP. the be I for both the of initiatives for of is event. more our have European discuss of SAP we our plan the stage next on now anticipate is date the early program. continue rigosertib be no take of in end the IV in that deaths this the testing to will focus year. have in place XXX forecast Based analysis. whom failed. by not of are line recent Phase on patients procedures reaching couple early partner a development Based events, process planned on our to analysis interim in as of guidance, the by modeling, of topline has potential death business analysis weeks interim tied will possible various our report pleased effective triggered created accurately focus is reaching the In we analysis as patients, number trial the we by been interim the completing number Medicines MDS geographically analysis will SAP, most it the for Agency. second progress multiple ADA-ed precise advanced we within III for earlier that our events. this interim very statistical have FDA a HME on the we year finalized main could hypomethylating and of preidentified a time Since of interim as complete to under IAA or the pipeline

to MDS SAP As trial preplanned we of choice analysis; permits and analysis intent trial and statistical inspired have SAP. scoring in classified ITT including a were survival IPSS-R treat scenarios options, success the expansion discussed design by patients overall having as as or the system is high statistical population criteria. predefined in previously, and the adaptive VHR under the are and for parameters futility permits using risk. The defined The very two these risk subgroup of

study line help is on Phase second learnings trial. a population of from time trial of inspired designed III the based being As our in is targeted a This conducted on patients and define reminder, subgroups in favorable of improvement likely of the believe experience overall of to to helps identification the survival. a most the endpoint increase primary that likelihood patient outcome respond patients We who population study. of the appeared

countries now rate measures changes trial As Asia of study They enrollment XX, across the for XXX new continents, within slowdown a just These and and four the XX of to expect efforts mid-year, and patients addition Since I'm we including the more we this this had sites. will to remain CRO trial. actions led Australia. pleased report this in experience countries North recent that in October in be the enrolled that America, three are Europe, in undertook had enrollment global sites Only month. inspired five for paying open sites off. a group. these occur enrollment to increase we

enrollment be to XXXX, XXX the of half full by after topline in the we second expect in followed the of half events first achieved As result, XXXX. analysis

the is rigosertib first After Our potential regulatory Phase in obtained we high study as for a the trial. and inline expansion then with second azacitidine FDA advance of guidance combination started program of phase EMA risk MDS. in oral II from plus XXXX, the and patients completion therapy an

with results of half sites the only. limit expected SPA The plan accrued expansion sites up multiple one-to-one of rigosertib III trial. and trial than design trial submit to has USA. randomized in is to of the requires III the azacitidine year-end, risk development trial a to the to high that trial be Once regimen. combination those Initiation this control the trial decided first pivotal of by and both. more plus Leukemia of this approximately resistance the is and therapy warranted. in We in XX or the combination been the in agent study to conducted and is The first the plan data Phase patients XXXX we with [AML] also MDS. indicates from designed combination progress, present rigosertib highlighting of compared hypomethylating results of U.S. may encouraging placebo transactions process. optimization is to awaiting study Phase overcome patients, demonstrates trial half of Based scientific additional conference design selection XXXX have to azacitidine trial the under to oral business on a that expansion this FDA Acute further III line enroll we at or now plus planned which financing expansion data are presented of in the early Phase initial the We Myeloid a the expanded is protocol Previously globally complete,

our it as MDS is Given program. by of the row go future. RASopathies or front quarter is XX% that of as lead this intention in two during study advancement on also AML complemented develop programs to recent to many AML, The in patients our collaborative advances

or RASopathies. as strategic proprietary entered Development York NCI, expect RASo trial a protein in combining start rigosertib Dr. may that Mount into pediatric payloads third U.S. our of all NIH. and key also pediatric select presentations that the to transduction. from MAP and academic University completed collaboration product Collaborative with approaches rigosertib. the new family will the to meeting develop evaluate advance with The or by The developments and We to conjugates platform. activated to to discuss nonprofits. to hosted San Research major of compounds clinical collaboration related report we novel a expected mitogen kinases of Institutes Dr. patented In a genetic Also, meeting institutes and be RASopathies next quarter, in the for with potential initiated our the to or have pediatric RASopathies. markets rigosertib and phospholipid to new stage multi-institutional Health Francisco. national National year CREDA, include Agreement NCI. by delivery which Elliot we mid-October, pipeline we patients discussed California, in funded for sign Sinai to provide in Bruce signal such early of Cellectar Biosciences I'm control Stieglitz featured New trials pleased ether They opinion RASopathies leader institutes by select syndromes Gelb This the phospholipid additional usually the and drug at mutations collaborators to that have caused is

call stage the to Financial for are results developments the Guerin, in programs our quarter. our progress programs underway exciting by the a in We Onconova's and I Chief financial the earlier our Officer turn in over encouraged of late discussion stage now collaborations. will Mark in

Mark Guerin

cash December XXst of the At third equivalents of Ramesh. end as to the our cash totaled and $X.X quarter, Thanks, XXXX. million million $XX.X compared

for comparable total $X the Our respectively the the period his ended quarter for XXXX $X I'll the month months third nine to hand $X.X million and was Research periods million for and the compared administrative for the amounted the September for a ended $X.X General closing the $XX.X quarter for million $X.X expenses remarks. and to million to XXth, the for million million ago year XXXX. nine net to for $XX.X million million periods. revenue back $X.X million $X.X million year. and period expenses now were last compared for in and $X.X respectively Ramesh the nine respectively compared and call million for and quarter $X.X and months September XXth, to same million development $X.X third

Ramesh Kumar

Mark. Thanks,

in rigosertib to annual at December, relating data meeting ahead we to ASH Atlanta, Looking present the to plan Georgia.

rapid of our from targeted follow-up Scientists, rigosertib which presenting first clinical our II on + XXXXXX under combination setting the Diego orally azacitidine conference administered rigosertib Pharmaceutical and Association a second week. stage mechanism These risk transfusion indications presentation the therapy the in also results MDS. ARKX the We're use in gratified a ON oral oral studies second to or trial. stage poster I'm Our will potential XXXX. studies in for of single low long of American inspired beyond in in patients trials highlight San And term by studies action next agent relating rigosertib MDS. at inhibitor three will catalyst of the the be are late novel key multiple Phase line trial, the and a presentation AAPS for rigosertib progress detail CDKX/X will dependent

and inspired We towards many year. expect the combination achieved programs pipeline pivotal that believe oral of SPA the lie These soon next collaborations enrollment Phase and early for III trial be opportunities an first a of We're the our in program full half advancing XXXX. the the can analysis interim death rigosertib trials demonstrate ahead. of and

you now on forward updating I near-term treatment are proud in to our Caja? milestones. and to to call would discussions. We making like open look be the the advances to landscape

Operator

Jason from Maxim [Operator Instructions] comes our And question you. McCarthy Thank first from Group.

is line Your open.

Jason McCarthy

for taking thanks the guys, Hi questions.

expect? high trial? benefit in inspired it us population adaptive just most you us great what are there on that where can what patient the thorough your First to interim we the opportunities whether could question ONTIME analysis. patients Yes, to point the possibly risk are trial walk Ramesh, possible very the data outcomes you design. skew walk the is to is a saw we Can thorough an

Ramesh Kumar

Jason. you Thank much,

As new development you know want of FDA, effective to Because accelerated. the very supportive be the design FDA they trials. is

as So, pointed either subgroups or certain by in design by XXXX, in you trisomy Lancet the early very by defined monosomy subgroups X high publish which when inspired which based such the are we we strong karyotype or risk on IPSS-R showing that risk as defined the findings Oncology X out, core.

a drug. core benefit. So, action the be rationalized rationale, the or indicated of this greater the biological could on based the higher mechanism And risk

roughly there this demarcation be us risk these correlated or right make core or population, very objective risks majority in that the new ITT subgroups within X) patients, IPSS the which tell criteria, keeping composite the in And was can prediction patients, patients. defined the another risk drug previous the allows selected patients. X) a activity the is is by were the a activity. exactly mind, trial are that very of risk that's be what two very would I high system we the So, X.X subgroup. better system, our activity of which or high continues the trial the risk you higher carefully that a all the took that the risk we trial, the had factors very decided significant compared to trial. which IPSS where the designed in be to cart scoring group for out to higher, define majority in the We was Then inspired to is high with as is ITT patients the risk which which ITT the to larger. finding the And a new of group the that and higher

So, decision adaptive very point only us at allow to either topline analysis will program. at interim or end design make high risk to the on a focus the

one adaptive only just element by we which is face the in a risk which road in is of fork third, question very to standard in adequately. the continue the So, trial introduced, second in is as is which interim to refine several on our one the analysis the adding definition more the at design forks to continue the summary, is not hope design. high patients One road. the I the CMO trial. a creative that And patients I to focus addressed planned,

Jason McCarthy

had, question. moving gone lot it's event. significant well into and National at KOL some really just A what It's could event, one think the over in like other that myopathies a more It the disrupt initiate work plans a you. involved they getting seen seems there JMML start and signaling Institute just was candidate. role Cancer to sponsored R&D there That RAS has studies rigosertib discuss that is thank you RAS don’t is some I there. discussion mention And are, maybe cardiac to targeting XXXX? rigosertib the decades pathways like and indications multiple that known is of and your of of plays drug Can to first or some real RAS related investigator as where

Ramesh Kumar

UCSF strong young the Thank mostly disease like there today push field, is children diseases, Charlotte from then fatal There Dr. you. affects were all the no Niemeyer this it's Stieglitz, of And the very available. we Dr. surprised. is second because these families and very from RASopathies looking Menlo started in Gelb, advocacy at When cure, and and Germany. for the at coming cases in experts, almost Dr. no a we investigators patient comes the treatment

So, single there's the of RASopathies. these found dedicated up their study experts able And lot entire universe RASopathies. single of different to and rare, as as revolve not RAS as big entire a a is in that by journal that have which cell, added point And out career in when or as we rigosertib And it's RAS RASopathies out we children, patients pathways. by is around the is actually pathway, you pointed a young as of to a within affected published the and birth single or pointed binding of we which define that this disease nodes mechanism. attack pathway XXXX many its XX lot their key And entity therefore anomaly. year, diagnosed RAS this very really domain we a a every weeks are a control RAS you out network some many not is

resonance, a like gave to good then which was ONTIME a grant Society organizations $XX very help. drug to MDS. So, there advocacy at study with patient and will was when And made Fruchtman wanted million present there Dr. do NCI the our UCSF other of in remember they as to story, we a to complete Lymphoma harmony families the visit trips between RASopathies the to Leukemia need our to you and the the Congress to the our and many available talked all us Steve CMO, the

known they in of JMML. is children for MDS a great also which as affinity deal So, have

and second were half So, storm this together the last which able multi-investigator a came multi-institution, pull sometimes year quarter, of together a and this culminating perfect study to in is we we the preclinical for I by fork reviewed trial and speak. in a NCI, approved as both as as has JMML well funded which all-comers for being to clinical be protocol the Phase in

Jason McCarthy

thank taking Ramesh. you for the Great, questions,

Ramesh Kumar

Thank you, Jason.

Operator

Thank you.

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

open. is line Your

Joe Pantginis

needed little point. finalized took first to the extended And for get I'd regulatory to this can since to just Hi time and about is and both to good SAP tea that you the talk dot of EMA? describe and FDA thanks of the it the had like guys, different to just you guess this two Ramesh, some ice especially finalize question. morning, taking the my bit the a in you crossed I you I wondering the agencies question

Ramesh Kumar

our overall we in reviewed in very structure you. of together FDA Application started our proposal had we of put CTA XXXX, a as XXXX. mind, Clinical which our the part the clinicians approval statistician good the thank of Joe, Actually, trial August Trial February which of was and in our when

was from actually had we a agency. our you is point-of-view, we're then to are Japan. much subsequently the up and and our in not know just But as in global go meeting So, set everything pretty in written concurrence we oral this trial, U.S. Europe, and from also

partner trial Our XX% enrolling SymBio in Japan. cost their is to XX% inspired of the at

Japanese to gone the So, is PMDA the FDA. they have which

the A) complication is process differently slower. typically process. designed the than really process was So, the European is FDA European

the initiated got in then we FDA, went agreed EMA had So, to everything. XXXX. to what we went we advice had their Then we concurrence process, reconcile with to first back scientific the

different we an FDA asked a to us since And FDA. go groups, three adaptive vanilla a make sure correcting is to interim alpha design, mechanism prespecified are are providing executive of adjustments had to So, inspire there analysis. that back this the for because not the Alpha there the company, committee, there is the SAP, statisticians, mechanism this the appropriate to is firewalls, and

all question. the So, really when created really this I boring and innovative for design boring and which have publish get patients statisticians it trial into trial. a and that but I we this people helps most I in adaptive is and seems address think an that the is we say will the people hopefully SAP of helps hope and this

Joe Pantginis

maybe regard the does. No, possible. its mean of inspire the this to early all for about the, like to see the the I we XXXX around bit you combo, and able hopefully Thanks, can't benchmarks shot would in think I you I the and the best towards? patients would with XX that Would it could With it heard absolutely, ahead dataset. regard about what say being gives talk what its a I success our we date little azacitidine it scenes expansion you be address about to know things behind Ramesh. full these of time sounds phase rigosertib oral It look for consider expectations

Ramesh Kumar

you. Thank

had impressive. the of This As complete in of has announced data quite before, seen XX% not data remission. combination We XX+ before. frontline patients we of achieved the including been the was response Phase II setting rate kind overall percent the

explore us So, noted sense the was that and we in and focus on tolerability a felt lot for efficacy continue of to since to before going were terms XXXX, for focusing that. it exciting to that the made also data we inspired of of both safety that on

have we XX as in So this trial in year the XX U.S. different forecast, expect patients see all alone. we to sites in the about

was the to we that go additional enrolling trial not so time. since So decided Europe because quickly, to takes

X So and the success enrolled treatment that X little of we as drug. news get to after the based assessment had is is here the as XX patients response can have months will of on the be patient and good the

a provide various expect drug and of of the early since was started parameters So expansion and use we independence. this will the to you efficacy year, effect the data including long-term on have remission, in first lot you patient transfusion tolerability complete

and partial at that early a decided available. of we meetings we full to for to presentation withhold So or ASH wanted expect present are some we because reason this picture, the

events. phase care a XXXX this advance focus X and what have we and as in patient will select is taking possible by our on data we what meeting early will will as here where focus again it right the by dose then have knew original the experts of from and optimization, reported to learned we we we present So

so each expansion diary can of given in to issues. tolerability take the phase a So we note this have patient they

what XXXX. and early So conference making in will very think we the are we presenting hopefully of be part on I announcement

Joe Pantginis

for That's the great, Ramesh. additional thanks details

Ramesh Kumar

Thank you, Joe.

Operator

you. Thank

Jen from comes question Laidlaw next from & Our Company. Yale

open. Your line is

Unidentified Analyst

Ramesh, actually be Yale Gallagher, he in Hi out but it's Pat momentarily. back just stepped should

answered it's that a how and also the forward, anticipate any if I you moving Cellectar helpful? programs have the might about know think would but expand very and can, complementing that early the bit development talk you number days how I been your current collaboration of his possible little be questions on it color but pipeline perhaps

Ramesh Kumar

Patrick. you, Thank

know founded very As have years we was on company chemistry many and discovery to early-stage platform we over been platform the many XXXX, to of the rigosertib able since laser people identify market, proprietary getting covering especially analyst promising very, that programs. focus proprietary the since de-prioritized focus candidates. the is on But narrow our and and these drug

compound So X which have in of we a addition we great to relate emphasis we lot to ex-U.S. the putting we are that a compound the finding for are data and have acquire both that companies partnered with molecules from on for X/X in Briciclib Cellectar +ARKX hand, which our to already there these need and also to compound. or out U.S. CDK both because companies small is large partner phase

a So the to more XXXX, into compounds how we additional clinic shots hearing and on goal a collaborations have opportunities, in hopefully you’re focused on multiple going these can about remain be collaboration rigosertib. multiple lot particularly take the while we

Unidentified Analyst

That's Thank you. helpful. very

Operator

further questions closing Thank back like for to And I you. now to showing conference any am no the the [Operator turn phone [indiscernible] I lines. remarks. will from over Instruction]

Unidentified Company Representative

answer speaking remains Thank the day. you may and enjoy your and we you with quarter. for meet look have. interim to Thank to any you attention management rest you and available questions your with the of In forward that and your next you again today questions

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