CTI BioPharma (CTIC) 10 Nov 202020 Q3 Earnings call transcript

Good day, ladies and gentlemen and thank you for standing by. Welcome to CTI BioPharma’s Third Quarter 2020 Earnings Call.

During today’s presentation, all parties will be in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. [Operator Instructions] This conference is being recorded today, November 10, 2020. to conference like to now would turn over the Dr. I Chief Executive Craig, Officer. Adam Please go ahead.

welcome afternoon’s to and you Thank this call.

on After Joining me Bruce an will Officer. and summary of Financial Chief progress, third update provide providing quarter a today are Seeley, David Chief Kirske, our David recent financials. Officer Operating

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

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

and release. today’s risks contained information concerning uncertainties, press these in are Additional

description approved need a myelofibrosis X address the business, that how to the that of a filed will primarily later we in for with prior for statements the the advanced differ poor patient the treatment to years that is actual limitations remarkable of could expectation For patients with we patients pacritinib with in of XXXX. these as of severe unmet approval our one complete in myelofibrosis risks see forward-looking our reports past microliter, please to could uncertainties address per our a with development XXXX, FDA quarter thrombocytopenia, expressed cause with of related in XX,XXX commercial materially with those further significant recruitment the SEC. results of and the with is This on more submission initiation to constructive quarter due from month, than was NDA first outcomes therapies. less launch as experiences result as group for well patients which platelet announced to importantly, as of severe counts rolling submission and program. myelofibrosis could review of the pacritinib This thrombocytopenia FDA we severe development our thrombocytopenia, CTI, medical dialogue Last pacritinib defined progress our periodic subject

the these the PERSIST-X prior At with treatment the available involved frontline severe on accepted. in include data and completed for Phase focus submission standards will focus outcomes from safety JAKX patients X and the and and the studies discussion NDA exposure based the thrombocytopenia pre-NDA patients study PERSIST-X data an available will Our patients meeting, was from our from these with on studies. agency data inhibitors. PACXXX submission our NDA the proposal to on The both from naïve

Our confirmatory ongoing Phase this patients, goals anticipate prepared key the data the be previously now announced, post-approval market to trial, analysis pacritinib X we study. we as than we currently rate ongoing our is Marketing. growth pandemic due planned To primary With enrollment and potential to slower is XXXX, begun in trial XXXX. present pre-commercial completed the at execute the to as of launch but have access and for have of that the in to have hired expected we Head continue on including regards to COVID-XX enroll commercial activities, make PACIFICA we ensure are and

the COVID-XX. patients in also The XXX providing look standard the of pacritinib patients study clinical PRE-VENT David? COVID-XX double-blind, at endpoints of PRE-VENT, compares pacritinib the PRE-VENT plus I Phase with X analysis in severe membrane severe update we previously interim trial quarterly versus extracorporeal set the As XXXX. of care standard in care on X placebo in announced, are provide first David pacritinib review age XX. with hospitalized placebo-controlled invasive at randomized Phase patients financials. the forward the a to primary to of who expected our oxygenation will With progress half mechanical of investigating an of die We hospital and/or on multi-centered will patients with our patients ventilation let that, COVID-XX. data or proportion of through in

in $XX.X to Adam. diluted per per cash the basic ended to share quarter for quarter for for Thank $XX activities, for and for of basic XX, and We diluted share $X.XX as move X loss the and X and X with fund or XX, we period XX, months or per operating loss as Net X December pre-commercial loss per share We the $X.X $XX.X guidance million we spending million of cash $XX.X the was compared of million we same million process respective respectively to the loss equivalents thus XXXX. $XX and/or and or the XXXX you, Operating and $XX.X operations provide per anticipate per a through months compared $XX.X XXXX. the basic and per September Net loss we engage fourth and enable XXXX $X.XX per compared loss loss million XX, updated compared us into in totaling million of $X.XX $XX net and pre-launch the progress million And diluted will phase. same to period basic increase for net ended loss in share ended loss in XXXX. and to million of XXXX. share September $X.XX the periods additional $XX.X cash XXXX was our XXXX. months to million diluted expect loss regulatory September was our currently as further into will our million position the ended an

focus rolling team. tandem, the trials. number is pacritinib, submission our and we one of are our PACIFICA PRE-VENT steps a taking activities cash strong progressing position to of for pre-commercialization out and however, for commercial priority financial clinical to completion and next pacritinib mentioned, our With NDA that build through we in our end Adam are are the runway underway in As year

Adam. now to back will that, it hand with So I

need. David. pacritinib of treatment have Thank important delighted medical are to in the approval myelofibrosis year may We severe first for call to of the of patients the This submission we with an the launch remarks. regulatory next very In that commercial XXXX. you, thereafter NDA in quarter for area subject open begun of to a with the forward the concludes look submission thrombocytopenia, approval unmet the completing lead please to potential our summary, Operator, prepared questions. of

comes question [Operator the Instructions] with first securities. Benjamin line you. Thank Our JMP Reni of from

Your is line open.

launch hired Marketing. maybe Can guys. plan you commercialization with off you Head for Hey, taking how questions. what just Thanks and afternoon, give a I the of of starting a force know sense kind is the sales remains that done now to big to going couple us the year? last potentially have and half a have potential be between good of the second I in and be

by first will component, question – and the force that. sales way, I for answer you Yes, the your thank

size working speak. companies the small I and force indications on our have of part So, as this will hematology niche in Bruce sales hand approximately launched with oncology somewhere the be of the second very who reps. question is XX we to keeping over other XX in Bruce? will that actively the much between

Yes, thanks for question. the

couple key One in We bringing now of a on is have the positions. been right leadership things. focused

marketing doing So marketing part affairs, medical our bolus have roles as expect other currently you effort And year to of openings market and accomplished for as far We and we as launch. that we have market the extensive that our significant of first now. as heard activities more for some will don’t later until right get have we the access got initial hires. we approach we next of into an research support leader hired are hiring commercial be underway, organization the

are several demand be research, firm are research that efforts to up presently the ongoing and those working market We able forecast. to have on

understand landscaping have to activities to to be time marketplace, the also to at and positioning. marketplace us more of our that launch able the today, help We us be able set are help

to the you in ex-U.S. don’t going the asked I Got how the won’t thinking question I is know is focus Adam, before see U.S.? activity, but are are my ex-U.S. with that it. maybe you opportunity, you something just do about past, in really if And that have to this next

it’s the operationally we team more the is are adept U.S. and to the say, – leading I Reni, that that’s will U.S. the within

with For approved in be PMA I that pacritinib I met we ago over year to trial. wanted the think Europe, a clear We another would they to complete it PACIFICA. need made

given the skill our So, without for suspect once partnering and a better complete, set, we partnering PACIFICA to option then I would is Europe or be [indiscernible] us. have option

already one submitted a you the is And if sense a final have we corporate pacritinib see are the about talk this a you in do and it. maybe on presentation, the to focus for us that us IST removed Got have program you ASH have the fixed bit would you going forward? upcoming going little me exactly if acute what GVHD, you more from can potential to for

Yes.

certainly that’s now us. interest of So, for

IST very to very the tacrolimus therapy, therapy very, XXX the the a of We the Moffitt. patients of controls. good for excited graft-versus-host sirolimus are work parts and Clinic acute showing days showing it’s within significant reduction historical to has and the the is in of What in Mayo come by and compared including in study, out early rates response first pacritinib

being acute it’s taking is That a expanding a very that encouraging concept. we X would that’s that’s show we IST. if then So, into currently graft-versus-host. company-sponsored to a conducting company conducted as data promise, continues activity in almost an trial a And expensive believe the Phase and to from And data, us. proof trial of consider

the opportunity that are new as up I and will data, repair we today with glad develop So, an brought do I encouraged in it we to see and you case the indications. it very drug am

good very Perfect. you luck much and forward. going Thank

Reni. you, Thank

Thank you.

the & next comes Our Messer from Chad Company. with line of question Needham

Your line open. is

was on taking is for Unfortunately, everyone. aGVHD Hi, you thank and my questions. Gill question my Chad taken. This for

mechanism you so COVID having with how interaction patients if action I and of a us remember the do pacritinib could to something fared about little with has COVID, for and just far? inhibitors JAK remind IRAK also it some have So bit in

you. an It’s thank question. important Yes,

activity fair the here potential of the down-regulation multi-kinase shows the has interleukin-X that the think it macrophage It COVID use be makes storm. potential I the to CSFXR and IRAKX of in setting, cytokine particularly through activation sense is pacritinib activity can answer activity. on down-regulate and its storm and has X it also JAKX part because of the on has cytokine

And JAKX, thought the pre-clinically just an JAKX to because example, why the that’s obviously, it to to do and to have one of we to for alluded that that public multi-kinase other So important recent proposition. IRAKX to specifically company a think in thing do the favorably kinases don’t had that it you the health welcome, setting. the we compare attractive right crisis the very this and conduct was we was trial us – obviously thing We activity for We in we inhibitors, as we effect. it’s kinase setting. for respond

congratulations PDUFA date. we keeping Thank and very the Alright. on you progress on an will much be up and eye all

I you appreciate Thank for that. it.

Thank you.

of Capital Our comes from Lake next question line Thomas Markets. Street Flaten with the

line Your is open.

Hey, on you thanks heard I taking you can was maybe just different thanks on patients could doing that? there the study, keep be a [indiscernible] XXX Adam, you – explain questions. quick it to and just analysis bring served, be XXX patients. maybe was speed but would that for I said got or wrong, based question If on that interim with the going COVID endpoint preliminary that a so to you

we standard. quarter, are first the which as in few we on study quite increased. we to them we in but than next expecting standard of size, April from a the and XXX between significant trying the fact increase patients had XXX XXX, year this care Yes, because the enrollment weeks more sample the of last Yes, in had in the increased and when and COVID has U.S. started pandemic it changed the the We now. [indiscernible] are

about decision, we the a decision needed a size. make good interim, larger to thought more a precise we sample So

that a ventilators. is the change reason use that’s of has in main why. instead practice the The care the in been change So

be to therefore, so we all with always increase to sample be more And conservative our conservative, as are to estimations the size.

complete priority on to the decision due NDA FDA? you by And first the it. the review expect what if then the earliest might the in quarter of – to hear you submission priority Got

for sure we indication. that should review, it’s a The FDA and but get to the need time application accepting right We the should two review. hear unmet get make application expect months has medical months. whether at have have the small within before X that we And priority we We and hear we in review do complete priority to filing. don’t

opportunity and expect give priority approval there us be would end to before case the of have it review do the an we XXXX. as was So, to

Fantastic, great. questions. Thanks for taking the

Thomas. you. Thank

queue. I you. like the back showing am now questions over further closing remarks. any call not for turn Adam to I to Thank in the would

Well, the you further the to joining everyone call today. look thank thank coming forward for you Amanda and conversations weeks. We over

and call. this conference gentlemen, participation. for your Ladies concludes Thank today’s you

Everyone have disconnect. now may You wonderful a day.