CTIC - Earnings call transcript Q2 2018

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Operator

Good day, and welcome to the CTI BioPharma Second Quarter 2018 Financial Results Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference call over to Julia Balanova with Solebury Trout Investor Relations. Please go ahead.

Julia Balanova

Thank you and welcome to CTI BioPharma’s Second Quarter Financial Results Conference Call.

management, call by questions. open remarks formal the will conference for Following

Operating me President Financial Kirske, Chief Craig, are Officer; Chief Seeley, Joining Adam David and today Executive Officer, Bruce Officer. Chief

those may that differ are during we we by make and subject anticipated guarantees forward-looking to statements forward-looking of please materially Such that Before on expectations. are the risks will current statements. begin, cause based statements forward-looking of to this course future from actual call results note not the performance uncertainties and

Additional and quarter XX-Q information and ended will the turn in quarter, our Commission. Securities June for concerning on these now uncertainties of is for second quarterly I company’s periodic risks financial Exchange the the call the contained reports and the Adam. with over filings the section to Form the and the XXXX reporting in press Factors report XX, Risk release company’s other results

Adam Craig

the you and Julia, good you, joining Thank everyone. afternoon Thank for call to today.

data and pacritinib have. you List developments the call PIXXXX Outstanding the these our And of any detail XXX a then As Monitoring the following second authorization, on marketing Medicines pacritinib. continuation each trial PACXXX you and top We of for Data discuss by take questions for with Issues to received of for discuss pathway of Committee. new the a EMA, drug application. line the the announced application productive met Day reported Agency, a greater a quarter. from the data Independent We busy interim FDA today the trial. may or many European in of submitting we We’ll We the review first we had know, for

will who be recruitment study patients be pacritinib, second up dose open-label being medical dose myelofibrosis data Pacritinib of with and first patients patients the We to completed JAKX ranging The candidate, the this that for reached have development milestone prior of identify unmet in with expected important III. patients, developing to are study which clinical inhibitor the therapy. the ruxolitinib year PACXXX to by evaluated top pacritinib quarter is the started lead follow at planned expected in thrombocytopenia end line is XXX in myelofibrosis purpose particularly the is to analysis interim and during need this quarter currently address with received XXXX. who therapy. PACXXX. the of enroll ruxolitinib of the Phase generation those we second an the The study Our is will

review, IDMC’s the Following the modification. study without continued

Importantly, no concerns concerns of to meet cardiac identify later the will when study they safety any data IDMC, again not become second about the were interim by events. The IDMC did bleeding quarter PACXXX available. more specifically, review this or patient analysis agreed and to identified

the the positive As have Type US patients with path we’re pathway clear pleased have we relationship need, and product recently announced, to now very for FDA. bringing B this with a for We in the approval regularity meeting the discuss FDA pacritinib. CTI now regulatory has and conducted with we collaborative to

ruxolitinib the those As with July, patients these conduct study thrombocytopenia in with therapy. randomized myelofibrosis. in pacritinib plan of new Phase to study expected III as such now we patients, to announced a at address The medical CTI severe unmet while needs

PACXXX. the PACXXX discuss new FDA patient protocol the to dose III we study, analysis Following Phase to III second trial We’ve and had to finalize of meet expect the from design with the the in begin XXXX. the interim Phase identification following recruitment optimal the of

that granted a pacritinib. issues. the our will in Issues of allow a Day has just The to by and XXX to MAA Europe in Outstanding perusing application is actively List into additional outstanding study CHMP data also that PACXXX from company the We’re us been to responses for marketing authorization two-month incorporate see expansion

expect to in quarter to later we responses XXXX. such of As application see the October opinion our now in and fourth on receive the CHMP

like we announced July, with B-cell showing and with compared on primary in to an that pixantrone and lymphoma. gemcitabine progression-free PIXXXX update improve provide program. did aggressive PIXUVRI discuss not for Now rituximab results non-Hodgkin's to the endpoint In meet to topline rituximab the that combined patients survival

program set monotherapy in currently treatment are planned this Europe year. the no At patients we’ll decision or Pixantrone lymphoma. marketed refractory relapsed a are data by approval. make clinical a conditional CTI. the B-cell pixantrone Servier under adult on with non-Hodgkin's the by for It’s time, and further reviewing a later studies We future this aggressive is of

is in evaluating medical In a Servier new been update. pacritinib myelofibrosis. pixantrone has our next patients focus of now to Our options therapeutic fatherly to strong conclusion, unmet currently populations populations steps with will and is find program to see financial David patient we for regulatory new Europe. I with the the this options your provide clearly need interactions needs evident, the -- The potential is compound agencies. major partner -- ask and the of evidence for address

David Kirske

Thank you, Adam.

of months was for XXXX for Non-GAAP from Net XXXX. for operating the Teva As share-based for a operating March million XXXX. million the and in license was June in to non-cash XXXX. license was that Total receipt expense primarily a loss of achievement ended period quarter second to the for period Net $X.XX $XXX,XXX in share XXXX. $X from $X.X same XXXX, XXXX period pixantrone compared A collaboration the same quarter XXXX. quarter of million the GAAP for compared in share-based for quarter XXXX. XXXX. of second same million of was share net cash for the of income of quarter with Pharmaceutical in XXXX for in June Industries period a in TRISENOX operating same compensation the revenue million milestone compared received $XX.X the Servier or the as was sales payments in and contract XXXX, as payment $XX for the period GAAP compared the compared June recognition $X.XX second $X net $X.XX for the was Non-cash XX, $XX.X or included the XXXX, period $XX.X totaled of well income XXXX, quarter the XXXX the $XX.X to XXXX, the million $X.X for related excludes to compared compared which $XX of expense $XXX.X for total same or equivalents XXXX. to million agreement same to share revenues XX, million net expansion per loss, million the to to compared second million second due decrease cash XX, $XX.X revenue of to as in per XX, million million million per for period was in of $X.XX share compensation the the six same loss for or to ended $X.X loss per same loss

I that, back now with Adam. to So call the will turn

Adam Craig

formal questions. David. the remarks. please concludes open Johnson, Thanks, call for This our

Operator

comes from [Operator Matthew with Jefferies. Instructions] first Andrews Our question

Matthew Andrews

may for could walk next through strategy on approval commercial the this curious impact assuming by that how you your study, need how year? just new the European feedback EC Phase III Adam, FDA early

Adam Craig

said stated view, and have are for Phase We’ve The point response. to respect moment. plan Day And US other the remarks, EU U.S. conduct of the and conduct trial; medical with territories And to from in XXX at MAA the pathway managed advised very of still do FDA. very the working moment. -- as to areas Day commercial we significantly. I the the by clearly, XXX outstanding in different has territories. issues that, the for unmet another EU of are a clearly considering Thanks the really pathways to have III Matthew. you, a each that partnership started good outcomes reduce we independently opening the we in apart whether at is the We number potential two Europe of with during us, active received as which two a question. Thank FDA from process. But need of The as the have

Matthew Andrews

it you’re population or perhaps line time in free And of III, you this say or the may the as true populations Phase you're to to then at the patient terms target? considering? ruxo options taking second to And to or if intolerant your what are as relates incapable options relates it equivalent that

Adam Craig

cited So areas. the FDA to ground us two

there no are on first therapies. approved is The areas both where –

both we patients who have amount obviously we population less first of that on the -- PERSIST-X have the a is trials. platelet and PERSIST-X and than XX,XXX, data The substantial from accounts

meeting we got definition feedback the FDA, definition discussed got the in are – the The based the second population the of study. FDA we some Type-B second did with indication, at patients we And definition. the of XXX second-line line and the on on who the

So very this moving trial of XXX satisfaction including two decision aware conduct make identify be of objective have optimal a that, we’ll PK But on definition XX,XXX data, the forward the And what final or dose to which should less line. then at if complete point the the than FDA the trial. second is scenarios we using either go those all in will the here and another to we’re first the available data. we once

Matthew Andrews

kept bit the open I/II first lowest in And you population did surprised or arm studies? not not then interim, just considering that did objective early you see the dose was the aspire were in on responses SCR any Phase that

Adam Craig

sample the is with really. small Not population. to size respect very, The very efficacy

not So really.

the this is of and discussed IDMC. the with -- One really

One who’ll for the have three of patients number data be the is with nearly looking of us. again available advantages of times we’ll XX-week

look I data. at much the a we’ll get think better

of really variability very the made decision. the it I interim small conclusive to think in the it size make the at difficult data sample

interim us a glad would least to three there. IDMC number the which second patients be of and to So a I [Indiscernible], agreed times look at am that agreed having

Operator

you. Thank

question next LLC. from with Aprilakis comes Our JMP Konstantinos Securities

Konstantinos Aprilakis

new when in hear so expect just endpoints, it? think sort in the detailed the so Should the rehash regarding doses, as new should Phase endpoints to the specifically about design, of details U.S., a think X in on -- of for and more of Just what sort PERSIST-X trial we to way it we pacritinib Or timing, and there forth. III trials? new will of the more

Adam Craig

Konstantinos. you, Thank

the endpoint on to answer progresses need matures. will obtain identify will The those, data take the that either to the more PERSIST-X month. the didn’t and FDA to must to during clear particularly indicated timing likely more I which dose spoke be survival. I us, of and/or endpoints, as account about see. into part FDA year, be how be that with we the I when the trial, FDA we expect to of doesn’t data, made a we The them With in end of PERSIST-X. one because registrational With it and with the year very they very design what last TSS secondary next design, used those clarity, -- question meeting endpoints we we agreed to both to And trial. SVR. that on primary as – and data, trial. the clarity about then has the the the and OS most will to design. that the to the have have respect the I optimal a for PACXXX It endpoints, which we trial during more depending when purposes a obviously that would as So company timing, -- the us the various from made need do secondary been it's will important that the to FDA on But to limitations respect towards pharmacokinetic of be the happened have early and we wants think we learn that the trials need year, trial clear over

Konstantinos Aprilakis

the And those of discussion are opportunity update how partnering the EU, to as just going? turning in and us sort there to can you

Adam Craig

till don’t We the the summer reactivated we’re off Labor the last in our of preparing kick and process the early update is going any documentation discussions have happen At accept It’s the very the month. I on just of in following September. moment think at we need anything the We activity moment. to started middle It’s that really the early. we new I now Europe. don’t end. after Day. some early

Operator

question next our with [Operator Instructions] Messer will & We Needham take from Chad Company.

Chad Messer

us be upcoming next what maybe happy of you out of with Just more on expect would just detail this PACXXX, it. of with And tell hope patients? get walk what you there that good that can what will us level to outcome you interim given kind would we think of something should out through be you a

Adam Craig

detail of going said review previously discuss FDA public make level the The the clinical need we I to design the trial IDMC -- on, will be interim Chad. under data. we Thanks, But will we’ll the that depend second trial the the the new at by do after to moment. is still and

going not from the that data are will public on be we the more to be we’re confident go decisions IDMC we So there the and had in inputs FDA. to able no until

was reviews unfortunately the outcome, currently, ASH, valuable do respect With some but – pleased the dosing With that outcome to respect no outcome we the flexibility to around safety IDMC moment. We information would events. low which us like dose because of able the was always middle outcome go the intent, expressed drop. because be obviously to end arm be a will being dropped our particularly dose for an the within would the the trial be I've don’t the dosing, for lower I it the IDMC with interim. or with the considered and dose So we if would example, dataset. see gives review for most it what the would the safety us probably important, cardiac But was having high that good to level at said some safety the the and was that give in then optional can’t of the good concerns us level, abstract will is. and by futile of good submit first to respect obviously leading be around at were the

Chad Messer

Is And regarding areas seeking to this dosing other you what in them? then input on are or it as there get the meeting where from advice just FDA data, hoping just significant next input are after well? you're interim

Adam Craig

more have with [prostal] it III becomes Well, on the clarity them can dosing. We I Phase think about a discussion design.

And so that. do we will

that early, said responding other response back FDA and on. that that concepts a the to their We we one-off informing at are and early data, I that's to they and told dialogue the thing they're And the is that the plan I has discussion start their analysis to back will in optimal having don't want the really with sure of to focus want be including agency. the we for But analysis, They with safety to. conduct the them a And needs data exposure dose, after efficacy when data. discussion we data informed. be sure why dose pharmacokinetic detail. more to asked look us and us, the the input this make make we come early, interim, on go the us second response

them, with very we the the [indiscernible] outcomes come approach given and opening dialogue the one the we during how were good of continue collaborative want said made to -- of relationship and very asked it a were I was and now As they FDA. remarks, really the meeting, careful we the have responses We a to for those in us. with past, we back history

Chad Messer

And have III likely any on that it or? in look Great. the PERSIST the you then what size of do like? sort thoughts to size Phase Is of is

Adam Craig

and less the than XX,XXX than we probably and it That's from thinking. at depends the use trials. smaller look could indication. the what be we're PERSIST-X, If PERSIST what data the data Yeah, PERSIST-X trial population

-- the of be still obviously less and a is size our ongoing data. – still The using it’s older to that data the hard PERSIST should second But take sample predict trial size have collecting design PERSIST of we're than a sample because it first XX,XXX line, to an smaller. we that's

Chad Messer

Great. Thanks.

Operator

[Operator further Instructions] in At questions queue. no this the time, I'm showing

Adam Craig

joining today. to you, We thank we coming over Well, you to look additional with Thank through continue the Jonathan. In and for updates providing pacritinib. call year-end. progress summary, the months make forward

Operator

today's Thank you. teleconference. Ladies this and gentlemen, concludes

You may now disconnect.

CTI BioPharma (CTIC) 2 Aug 182018 Q2 Earnings call transcript