ONTX - Earnings call transcript Q2 2019

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good morning and welcome to Onconova Therapeutics' Corporate Update and Second Quarter 2019 Financial Results Conference Call.

At this time, I would like to turn the call over to Avi Oler, Vice President of Corporate Development and General Counsel.

Avi Oler

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

yet the morning's Web Investor www.onconova.com. not is release site, have on available Relations you seen press this it at If page our

today's our business financial progress. CEO, Steve completes quarter President recent On XXXX remarks, results. and Officer, After Steve Mark will opening the second Guerin, highlights and discuss Financial company's and clinical anticipated his Dr. call, Chief will Fruchtman, review

Medical Ric Officer, the to also Following Mark's Woodman, portion the respond our call. will Chief to report, available Q&A Dr. will of be move questions. we to

back Lastly, Steve some will and remarks a of come with milestones. final brief upcoming review

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

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

I'll that, turn With the call over Steve. to

Steve Fruchtman

thank joining today's for you call. much, and Thank everybody, so morning you Good Avi.

of with by Phase enrollment great towards forward our top The first-half X progress highlighted of events, Upon of global XXXX the trial. data completion in reporting death to and we continued Onconova, strong was enrollment first-half line for INSPIRE of XXXX. a anticipation completing XXX period look our pivotal

of international the all, to care open-label are to randomized of reminder study line relapsed, in patients with on, the of second rigosertib safety, single-agent the of an standard XX efficacy, therapy. to treatment the or and respond failed high-risk agent is INSPIRE trial this to Patients years than tolerability in and designed have previous MDS. with a IV less study determine age, As progressed controlled, hypomethylating

either supportive overall treat with The patients with best The randomized of the subgroup a approval, the of or is analysis which an in study to all by population. best patients physician's to the Prognostics receive There intent of study randomized the opportunity as IV therapy this of of supportive for survival defined very-high-risk also Scoring the care. second primary choice rigosertib endpoint care overall is is survival revised FDA the System. International sequential

including XX more already than countries across the In terms four countries the trial clinical in continents trial. INSPIRE The on participating sites XXX opened are in on of Japan. in trial, trial sites enrollment company open, XX new sites

because for on believe achieving its the during are with Additional goal coming of higher with the we huge opened geographies, be the support goal of there. strategy risk most treatment first months of importantly the Should being thus end accrual population is This of years. full number INSPIRE rigosertib INSPIRE XX in the study, MDS, patients designed XX will high trial survival significantly prolong adding rigosertib by than new of MDS more approximately anticipated to Brazil, the XXXX. sites and to the more

for of start rigosertib a MDS. this higher and In are oral of protocol trial, line for first risk Drug patients addition Administration toward Phase known of a also of azacitidine December applied we the XXXX, U.S. trial we advancing adult Food trial. azacitidine X to the SPA, December, and special the with toward scheduled assessment, In treatment which new INSPIRE as pivotal in abstracts the combination and of Hematology X XXXX. that with for progress trial a the for and to trial rigosertib pivotal the process Meeting, initiation the already combination Phase completion the on important of oral is present Florida. Society trial A have Annual INSPIRE XXXX, anticipate We SPA been of submitted of American Orlando, of to end the of number the the

our have made we including metastatic program, to investigational has our and numerous focus completing the on MDS cancer. potential we pipeline enrollment which and INSPIRE dual refractory XXXXXX, remains inhibitor in While first-in-class with breast ARKX, important also trial, of the progress treat CDKX/X ON our cancers, believe

of license drug reminder, for Chinese will IND which all HanX with for performed be Chinese a a food and have also HanX into The Onconova company studies entered U.S. development we received December and these for and guidance U.S. XXXXXX fully approval. ON to studies XXXXXX of plan. IND-enabling intend provide agreement funding we Pharmaceuticals and XXXX, FDA's required As in under with preclinical Food HanX pre-IND completed consultation a FDA, and manufacture the standards. compliant the for the the for Drug ON Administration with

targeting of of have not XXXXXX potentially the believe of inhibitors for that limitations. cancers drug targeting to well current of many promising cancer. inhibitors. responsive inhibitors its unique such hormone our who those ON these compounds positive, certain to not generation CDK limitations CDK For as indications with the ARKX be Due suitable cancer large current emerged the receptor metastatic potential familiar breast X/X you their very overcome have may candidate The field, we as has making as CDK of as X/X, CDK to generations are

believe opportunity ON potentially large we market XXXXXX address with very better successful could this therapeutic. a all If

known the developing of planned trial the rigosertib the pediatric non-acidic infiltrate MDS, rigosertib syndromes conditions of Juvenile to rare INSPIRE caused various a leukemia These with cells first-line are as JMML, Phase and aggressive combination trial most addition IV X and for a of that acidic globally. are azacitidine in oral childhood include of group genetic rigosertib rare treatment Myelomonocytic In common unfortunately organs. with RASopathies, we also excessive together granular Leukemia, by proliferation that the also and

these a cell only the a action advance therapy significant may invariably medical clinical stem the The and prognosis in this unmet JMML we due potential are very trials mechanism its is need. excited The year treatment is the and is JMML curative about lethal childhood into hematopoietic illnesses. for devastating children of unique of there of rigosertib Thus to with It's program poor. transplant.

Pediatric their with Oncology also patient has NCI from rash cancers. branch models patients mutated The Xenograph studied derived

combination investor, In investigator lung patients represent addition with plans we of X includes have with cancer. rigosertib all cancers. inhibitor commercially progressive programs, to the these mutated tumor non-small to third This solid plan an be a supplied cell pathway by or together in to pursue Phase PD-X available KRAS mutated human initiated study to of genes rash driven which cancers rash a

will in collaborator of along to XXXX, on commercialize in an a countries. payments trials has upfront the rigosertib Korea with exclusive payment by and rigosertib and commercialization progress rigosertib license is development and Korea for product the planning net conducted sales to SymBio SymBio for Japan supplies Under receive Japan and agreement tied of milestone conduct and us. Pharmaceuticals, drug sales. Japan. terms as SymBio our Onconova received similar development of for plus an and study will the well signed payments Onconova develop royalties clinical as these in milestone in

the lung cell we work year. to this mutated to trial expect Our conduct trial will non-small with partner cancer Japan in start us KRAS a continues and

resolution based business with planned platform of study platform trials. clinical platform. allowing to view studies treatment response. single-cell neutralized detection rigosertib that their than believe sequencing first as with uncover development, a genetic part may announced with respect cellular sequencing company DNA tapestry of tapestry patient's single-cell traditional and disease platform, the better that enabling recently Mission genomic is to The mutations into Mission San industry's Onconova collaboration genomics each disease in of With to tapestry unique numbers Bio at Francisco progression we mutations populations and We a level. single-cell with message, possible the identify Bio, heterogeneity

and program rigosertib research by and to pathophysiology tapestry the MDS These regarding In greater have lives are single-cell addition, and pathophysiology. abnormalities sequence of studies the platform genetic the to MDS that of including our of meaningful a the MDS in understanding set addition, opportunity difference outcomes. influences required in to in the we the of clones that rigosertib development the study, clinical determine and patients the potential and influence with make

in We along study also our registration see the novel partner with second license this and license agreement other rigosertib, to an solid as in China. MDS of into the HanX, with tumor development, commercialization high on HanX of of with agreement focused future. additional this important recently indications oncology advancement We risk entered and products in the rigosertib

China granted $X totaling million. $X $X at greater committed and to-market. China, stock the an non-exclusive and in a rigosertib upfront a to HanX license manufacture rigosertib investment common million In for an HanX in as commercialize to develop to Onconova well. totaling agreement, license rights, million these in for to exclusive premium This purchased fee a includes Onconova exchange greater Under payments

addition, HanX China. escrow In in development $X rigosertib expenses place greater million clinical in local currency to to agreed in cover

to in sales $XX.X double-digits tiered and receive greater their plus could regulatory, based to up net also to in by on in Onconova HanX China. payments, timelines. sales participate regulatory approval INSPIRE Trial our plans depending, their royalties development and million milestone up

for in product the HanX We support clinical China. initiatives our in will territories also supply sale will licensed the finished and greater trial

quarter of over Financial like our Mark discussion Now, a call turn for results I'd Mark? Guerin, XXXX. second Chief to for the to Officer, financial our

Mark Guerin

cash be believe equivalents compared June fund HanX, current funds and we XX, as Based XXXX. quarter Steve, million fourth morning, cash $X.X our $XX sufficient due ongoing and on Thanks, to operations and and trials XX, XXXX. into of as the to will everyone. Cash totaled million receipt late of of December our good from that XXXX of projections

to on XXXX November stockholders' the ended The for June to with the regain $X.X million XXXX. requirement quarter. company by the notified Net second comparable XX, loss by company's plan was quarter XX, NASDAQ has that was XX accepted compliance XXXX July million equity listing $X.X for compared NASDAQ

quarter were million XX, and expenses ended General the in and comparable $X.X million June million development $X.X second for ended XXXX. XXXX, $X.X quarter period expenses for in period administrative were $X.X comparable for the for and XX, the XXXX. and the Research million June XXXX, second

We a manage focus continue on primary to INSPIRE maintaining carefully while resources our the trial. completing

This completes back now turn to review. my call Steve. will financial the I

Steve Fruchtman

some ahead that, will so With to you. Mark. with would closing After thank period, we questions. question-and-answer and remarks. the please for I finish with Operator, the you go like questions, call much, Thank open

Operator

Pantginis [Operator comes you. from Wainwright. Our instructions] HC first Dr. question Thank Joe with

with your question. proceed may You

Joe Pantginis

INSPIRE, fluid. are are Good hopefully enrollment this morning, Guys timelines the and to questions. -- little with bear for taking one, so With regard questions is ongoing obviously bit very the new me. Thanks can my fluid gentlemen. a you

able be just on might time the to top might the have study the occur as as am that coming if other to continue guidance saying quite Brazil And with additional some into data well and I prior discuss read patients same line from events for your sites at time curious how that been So sites enrollment. you could now? occur we while

Steve Fruchtman

So Joe. to will thank you, Ric address your question. I ask

Ric Woodman

Steve. of them. Thank each There components you, try will question, to I address are your Joe. to several And

I of we announced you think may First of in enrollment a milestone XX%. all, as many achieved we know, that critical March of

certainly plan well by still We continues that. are above We Enrollment to of enrollment to planned. as the XXXX. end complete proceed

personal only look much studies, expertise but population of studies contribution. In own and strong not network the hematology hematology their Brazil forward contributor experiences hematologic been to of has We always Brazilian numerous very there global centers. to because my

this us allow group, year. every of worst So opportunity study to the certainly I The varies course enrollment over change the the complete prognostic in study. the think in will VHR, that

around running below will sub-group prognosis. relationship Median this has it's protocol months. survival events overall approximately close implications. largest It enrollment enrollment patients untreated and XXX per between and is about Obviously, XXX has Because Currently, there particularly possible be population that the required of number two this it the the this your which study, generally is particular survival survival for is is is of important a in events. well events. XX%. this worst And population when question four

in survival we The are greater VHR, tracking likely be certainly overall something carefully. the more anticipating the will the control is the reduced. arm the and And this proportion of median

lost One of small. particularly to the are think study is who is very is the of that I follow-up the fortunate things in that number patients

And will recruitment and to events both survival so, closely. continue we track

analysis. out, this a the particularly as With And subset. also go Steve primary endpoints for there for each I your thank and pointed addressed the important endpoint I is we of hope VHR may have when to them. be think questions, And Joe. that, primary you I

Joe Pantginis

as to next with assumption the guys And No, and shifting is finalization to in regard heavy to much Ric. you getting the SPA. with sort you certainly discussions My SPA. what over have, of INSPIRE? statistical then at I waiting about oral the plan. also from were rigosertib the very to curious FDA the does question for hot things curious the are? are you Thank was of INSPIRE is that. FDA and you would was anything just previously factors progress, discussions this continue know point analysis at the maybe on I But, talking gating the the impact and all be your I

Ric Woodman

again you is Thank to that for multiple it. question. There parts

let heavy clarify, discussions any don't I in First me we and are with FDA. think the hot

in and FDA. the discussions with definitely are communication We

Many requested at finalized our the the changes. point are We agreed initial of which responses we the review protocol. the where with through of we

points remaining clarification study Much that one upon. design on. are need we final two of is agreed the There or

of particularly study Phase phase very and is informative and a phase you oral both you us X certainly X. azacitidine when I and valuable FDA. registrational that X think develop positive And a for go has to have and become that rigosertib a thing the the informative

I -- an of study have X impact there only a oral been is impact The rigosertib The think terms with would this thing discussion that linkage on endpoint really might could there's with be future were and in if that INSPIRE no have we phase important. regulatory survival have positive has to INSPIRE, combination. INSPIRE. of

Steve Fruchtman

add unusual file. don't FDA said, but to Joe, And know really receptor as what oncology to just just response Ric know we it have you is in thinking,

trial. double will two because is through we as communication understand survival our three One be trial, response response trial, trial and INSPIRE have survival to second normalized. the perhaps will trials. a that XXXX. FDA confirmatory FDA they in So accepted peripheral partial response be we composite first response the response phase it the a way implying line, with both new And in that be have a trial views so expected fact, in this to trial has is the And count blood completed, the complete a with therefore, a first-half data the in it or a

Joe Pantginis

Got it. your indulge and for question maybe resources. helpful also. that's you one cash if very me Mark another current please, And towards would No,

how HanX. you You and just you mentioned that if am from I of inflow And also not that lead these cash? link based are a I based current leading milestones. potential including going on do that the timing collaborations was partnerships, of your I curious includes but that discussions sure partnering of to your to will anticipated of question sort which milestones, do milestones that could are anticipate a non-dilutive significant you on Thanks.

Mark Guerin

just milestones. think not I -- I I question, runway are we the in assume further our milestones. the part from milestone, -- upfront. that It The you call And, money the earlier not of It's upfront cash Joe. asking your bit that so, Thanks, it's If about little HanX. any mentioned we actually does assume understood a the out. are milestones

Joe Pantginis

saying be that you but near No, were timing payments put is more expecting, there might milestone that cash we as in payments unsure into understood. say a XXXX, you maybe relative not your I to like or am term little guidance? into current are collaborative the ready slip but just

Mark Guerin

That's correct, Joe.

Joe Pantginis

got Okay, it.

Mark Guerin

Well put. right. That's

Joe Pantginis

link And then this partnering discussions might to Yes. how going? ongoing how are the your

Steve Fruchtman

Joe. that, take will Avi

Avi Oler

Hi, Joe. Thanks.

near event. interest this up we heat announce matter process, company our as those XXXX at and very out thank top in we mentioning and their anticipated and after Steve business and much for approach nothing time of but catalysts to we Ric questions, as So, terms line that it. your are discussions data there's ongoing our seeing first for relates for and that timing development to will this

Joe Pantginis

a Avi. Thanks, lot, Thanks guys.

Steve Fruchtman

Joe. you, Thank

Operator

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

You proceed with may your question.

Naureen Quibria

is This morning. good on Hi, actually Naureen for Jason.

you space, has into flying So And as space would put most may been know fit you oncology the MDS question that ASCO reported where Onconova have radar. up some not of in advanced have within RAS space? under regard that's you KRAS been bit company and perhaps rigosertib quite a is as also in Could sort a has perspective program at of but but the broad data the player Amgen. particularly this context I to sort the of heating with in positive regards by Onconova it's just RAS a to which in, this where been an and

Steve Fruchtman

So thank you, Naureen for that insightful question.

think space. we actually by the reinvigorated So data has Amgen presented RAS the

based targets important for proteins action RAS of patients targetable, RAS paper modulated. by thousand As is presented mechanism the we the question you published rigosertib the the that data I XX believe patients, mechanism on a unique know a been XXXX thus only Dr. the and Reddy different. somewhat pathways -- rigosertib, a with is there's which action Prem of is there's pathway in over has been that and believe of Amgen interact Amgen treated in RAS RAS RAS with we've decades

specific It mutation, should rigosertib the abnormality involving gene modulate targets pathway. a RAS any theoretically

clinical of to September mentioned and of implications the question. Onconova mechanism with for conference other research we is our be and a space there first of with on time and Amgen RAS presenting reinvigorating in the word for part patients Amgen companies will the second add broader to based Boston the clinical it's XXXX RAS and research that, a thank of to targeting a sometime but this to action show to at number targetable actually data is answer cancer cancer and confirm labs for in believe along I I and data that your So and scientists

KRAS the is but the call pathways genetic and as is XX% of important or are involves into cancer progress. KRAS, focused are on are which came non-small the which to earlier of lung other care and a we days all Onconova will immune-oncology mutation has I cancer full have these develop MDS mutated to very has thus to of standard done should the in the of mentioned space cell patients and therapy target typically part we on that diseases me genetic, patients we MDS moving with and approach we believe it an lung since clinical focused of the potential first-line been We patients rigosertib the genotyping join changed have having but these

open will of and will to believe be there rigosertib the alternative initiated using we dose determine IO trial with cell patients KRAS part approach investigator alternative role rigosertib as of So agent targeting to oral commercially we plus part a lung Phase X mutated for provided with non-small immune-oncology thus of cancer. a an an the KRAS site with as

answered question. hope So that I your

Naureen Quibria

It actually that it'll my going questions mentioned you all the have, you. does, to KRAS studies to leading that be Correct. into set KRAS of you the regards thank And second with are mutations.

have you'll So in well the the in it SymBio with a believe terms study of ISP ISP combination going well? is PD-X a to a be as be the the I SymBio will monotherapy as combination or

Steve Fruchtman

you're right. No,

all for provided the cancer in a agent trial and target also participating non-small trial. the patients be providing and combination U.S. the be I'm the with trial for mutated free the KRAS lung in the sorry trial within free patients immune-oncology Naureen for will will will going for eligible Japan By on is We be cell way, immune-oncology. the to trial

Naureen Quibria

going bit a Do be, frame expectations the regard away to to thing, of I know the both and have far these. it's so data with are you initial readouts idea? for our can last you any these potential, timing if And any Great.

Steve Fruchtman

estimate will by trial number a first in known. in trial sees No, how be anticipate but entered patients we we we the the It's end the be trial X, we to U.S. XX really of year. patients XXXX we take XX to the reality. opening the Phase No on depending the long the of determine to the will MTD, the and maybe onto that's but not hope

trial, we're unknown hoping little trial data have a it's to we'll this begin So initiated the bit the year. but when

Naureen Quibria

for Okay, wonderful. me. That's it taking my Thank you questions. for

Steve Fruchtman

Naureen. you, Thank

Operator

Thank you. Ahu with from And next Markets. our Demir Dr. question Capital comes Noble

with proceed question. your may You

Ahu Demir

taking published was how I to much wondering approach very partnership first team, sequencing high in results with frontline trials for this we My Bio. have MDS, clinical will would be medicine samples through Also thank for clinical you are which Mission and question questions. curious my added trials, genome from trials precision the this Hello be will it's programs. expect CDK included when how approach risk patient and should potentially collected, implemented timeline that? when was will the I be your

Steve Fruchtman

Well, thank you for your questions.

that with particularly MDS. focus who analysis primary valuable tapestry for clear the certainly It's especially single-cell the have that platform many is known patients mutation or mutation when The either makes patients that not This that appreciated disease reasons of XX% of platform in progression vast think a this genomic Bio majority Mission in terms mutation. particularly of have I than more failed have one HMAs. the in estimated is setting a to each significance response. it of comes entirely and is

And and live valuable It particularly mechanism so understanding which gene collection conventional the look rigosertib aspirate. standard Mission a platform the novel than cells, the collected seeing Bio's approach We forward in from analysis. in to sequencing requires this of requires different of action does of of value somewhat these cells DNA, this is require patients. our

we to with patients enrollment X the different with would oral look Certainly, that well INSPIRE upfront even study I complete interest think at aspects required azacitidine. So this logistical as the some that combination rigosertib are and will as in Phase number of in the both of study. require limited the

anticipated cutting-edge is this particularly think be science valuable. I to

by discussing us of understanding and ASH patients I the it submit at our And this. value is looking field to a submitted mention are this therapeutic one in and in think who in did that you everyone that will HMA move genomics are in the sponsored is interest interested have areas. of I little genomics. into make of one abstracts that's but incorporating indicates certainly those abstracts extremely think the the ASH It failure. more we trials experience, becomes more platform is negotiation we investigator a gain as we'll of appreciated other I always when

all Thank of hope covered you interests. I've I question. your for your

Ahu Demir

You CDK certainly program. next very Avi. Thank on did. be you will the My question much,

catalyst So, IND. main the is of the course

to curious additional favorable showed publish I neutropenia other data compared XXXXXX reduced CDK presentations to similar where any your you actually ON plan However, factors to differentiating [ph] for previous was you of programs. if

any keep we that on? should So an results eye have do we

Ric Woodman

thank for you XXXXXX, ON in interest the XXX. Well, ON abbreviated

Ahu Demir

That is helpful, Avi.

Steve Fruchtman

This Ric. is

Ric Woodman

Yes, it's Woodman Ric speaking.

Ahu Demir

Oh, hi, Ric.

Steve Fruchtman

Better off with Ric.

Ric Woodman

you data. we safety in when promising ON are marrow the to gastrointestinals occurrence were see in at clinical is the a makes that, that ON that other animal what mind we data do other And safety have But that mainly model remains relatively XXX. to the CDKX/X to inhuman the that bone setting with preclinical first that that So have in thing underlying study with animal the keep human we no into have on effects hope What we we time profile. and spared, of the having limited models unknown. published similar XXX, will been systems the profile get organ see The has that one which reversible. said inhibitors, effects. our say can But continue this in I very

Steve Fruchtman

about comments And the that's hoping response commercially obviously standard ON lines are cell look unfortunate our excited available we're And see cancer - respond CDKX/X women compound CDKX/X and metastatic inhibitors, with to if Phase in breast refractory inhibitors, progressed to XXX refractory and ON breast X they cancer we're these add Rick's hormone XXX. on to breast why see lines will there'll in to the receptor that cell to be who to to to forward that that. entering cancer positive

Ahu Demir

taking time. Thank questions Thank you, additional you, if Steve. not of much have Ric. I'm I too two

you data. Will prevent it plan in indications? presenting clinical end probably NVS conference or cancer other mentioned of you Regarding lung the last in you any be September; be to Boston, do or will data like

Steve Fruchtman

inhibitor, focusing the question. Well, a it was of the emphasizing clearly, prove mechanism to be But deck the the that that I action RAAS audience. of great haven't that's together on rigosertib, yet, Ahu. put slide studies explaining we'll a

as and We rigosertib. asked the will and on cell about in you probably our Trial show question clinical with lung we're the cancer. present data both derived and data will KRAS INSPIRE mutated well patient based all thinking we trial with W Since non-small it, the xenograft models should

probably well. and conference. it should as we And because should at you that about data that So thank us helps that show question, we show think what for upcoming

Ahu Demir

question will last be My Steve. you, to Mark. thank Sure,

So covered the theme. whole I

know driver So, R&D for that this the in quarter. was was reduced Mark, I What that?

Mark Guerin

I when it think period part by on the to in program Well, in compared XXXX lower spending expenses offset that was as of XXXX slightly But the in partially because XXXX. higher combination to compared was XXXX. on INSPIRE,

driven that's the really but So clinical by costs spend mostly less it side. on was on mostly bit lower, are little Personnel lower a in driver the development spend cost big the combination.

Ahu Demir

taking I Thank I see. voices, appreciate all you my very questions. much. hear your Nice to you

Avi Oler

Ahu. Thanks,

Operator

Company. from comes Laidlaw you. Dr. And next Jen & question with Yale our Thank

You may your with proceed question.

Yale Jen

the been thanks and questions, Good I have for answered, and have morning, so here. many two taking

Is first development? of you the oral was is you correct? - that I If color heard that give rigosertib's if me correct a what I'm that bit that year. could of X so, toward the one trial, Phase us little the trial The end wrong, start might more

Steve Fruchtman

this Steve. thank you, Sure, is Jen. And

to now the let's Japan to So eager site have we perhaps to to that, other begin on would as support to collaboration China our It U.S. as up sites, in XXXX And HanX, very much is the open two goal and difficulty] our small know, of number trial. ability all a in would you Japan, the both but with select sites. because, a open because to want goal say, open DUBLIC financing our China well our a well trial site with be INSPIRE, [technical for of as in and resources internationally, number [ph] depends a DUBLIC in

in and be to that to be to able patients these the at small a point we due So do in trial believe but U.S., there. in from after beneficial it global up development in open DUBLIC number like to at then XXXX, for would obtained, a that China, is financing this premature a to to all we'd the start required additional trial, trial with financing. the open grow then site site it sites of the rigosertib to and But be to small Japan would sites

Yale Jen

just that or two would events? depending on getting spot the And designation separate be that's the the

Steve Fruchtman

Well, we go sites. through we don't as need prefer efforts But to you the the it. know, would open the we reality, of obtaining spot since in in

already from is response the a key have We FDA accepted They've received feedback. What trial. the that?

the And two what FDA We also from control of key the approval protocol. those compared principles arm. the are is understand delta anticipated the to for key, the

remaining the So some recall protocol. with FDA, some about the I things, factors technical discussions

So to a working are the a receiving is: required. and But need it's your a We to X to spot trial. that We the question with necessarily pivotal new wait the FDA, probably not Phase to anticipate don't pivotal up have - anticipate open for happen. spot, Phase answer X

Yale Jen

Understood and patients that were, is one spot guess, more or the with appreciate INSPIRE in I the you mentioned also earlier you which the to question collaboration here, that. apprised study. Maybe mission the tapestry with

the what going attract some second First secondly, or today? alive or in is all send, efficiency there to bit would be detail to be of testing? - all, a would of you when that And you're response? to little give Thanks. treatment still study actually - terms conduct us more the measured the And aspect patients

Ric Woodman

questions. Thank you for the

analysis, tapestry study won't to cell the which mutational changes for fact in by dynamics will in value that single the limited patients on profile. have of be the we of the understand baseline that of genomics think I the

be I possible possible the coming it's patients into think samples. who're study, it collect that for may potentially to

shipped which and the us what appropriate they in to Mission keep discussions around limitation the in a this and single world. anywhere from not when can DNA required. time in they be Bio, And cells mind on in are the that with obtained that stored world samples These However, there's get are analysis. that is told do can sites

some analysis be upcoming that protocol think certainly It study, the of included obviously have the to analysis. challenges I we in genomic the genomic and with greater that exploratory endpoint logistical Phase easier INSPIRE. X would are So, form with in new include

influenced by be will logistics. lot a now right think I So

Yale Jen

a Okay, the Thanks on so congrats and great. far. lot, progress

Steve Fruchtman

you, Yale. Thank

Operator

I any to am Fruchtman Thank any questions time. further showing over I the remarks. like turn to for you. further now back at And call this would not Steve

Steve Fruchtman

for We're progress excited participating addressed. making I hope programs. call, today's hope INSPIRE and other pipeline about in questions we thank your update all the the you and enthusiasm. Well, we've trial on very which we're excellent share our you And

XXXX, a azacitidine in year; IND rigosertib the X of Phase Phase of patients KRAS-mutated lung the plan In INSPIRE the an combination this the in FDA the medium-term trial one, following first XXX year; the assessment for of protocol to XXXXXX; the standards. and data four, a three, in will and finalization and filing our compliance and line study regain high importantly, first-half ON of near two, of the listing of with cell of NASDAQ-approved Important non-small milestones of patients in the agreement initiation XXX five risk death include, for and top of MDS XXX complete in required pivotal refractory accrual for addition look special events. end executing to the we submission X cancer; from Phase the oral most X INSPIRE with enrollment trial by our line patients release trial with rigosertib

This concludes closing remarks. my

always, appreciate we your support. As continued

us, any reach contact some questions, very out to to if thank feel have free up. us, and milestones please important you We and Continue you coming follow and again. have

Operator?

Operator

This for Ladies you and gentlemen, in thank today's concludes participating event. today's call. conference

now You may disconnect.

Traws Pharma (TRAW) 14 Aug 192019 Q2 Earnings call transcript