KPTI - Earnings call 2 2023 | Karyopharm Therapeutics Inc.

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Operator

Good morning. My name is Jason, and I will be your conference operator today. At this time, I would like to welcome everyone to the Karyopharm Therapeutics Second Quarter 2023 Financial Results Conference Call. [Operator Instructions]. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Elhan Webb, Senior Vice President of Investor Relations.

Elhan Webb

thank to for XXXX discuss and company and today's us financial operator, recent call conference Karyopharm's progress. you, you joining all on results Thank second quarter results this detailing release XXXX. press a second quarter issued our We financial for the morning a on This available we will today, website. presentation reference release, slide that our during along call with our are

quarter provide joined and for Sohanya and Reshma, today's as call, Richard, results development. seen For clinical our who recent on an will by the on Slide second X, I'm update Mike,

our with we those X. FLS, you Reform FLS purposes Litigation under including a is of most factors, views Before results in recent Actual by statements statements, Form Factors Any with today the I that provisions various other the may formal those as materially SEC make our Securities Slide discussed file SEC forward-looking these the begin comments, constitute of important which Act section may result differ only. the will Risk of remarks of filings that today our for indicated make harbor Private the future. remind the as XXXX, safe XX-Q, of we from we as will represent and in the on various forward-looking outlined in on

to rely turn these turn Richard. our not date. I will While so, should later even do to over at the Slide views we views future, some therefore, X. as elect call to disclaim to you any obligation FLS FLS we any if may these update point specifically now as Please of in the change. on our representing

Richard Paulson

for morning, second everyone, Karyopharm's call. XXXX Thank you, quarter joining Good thank earnings and you Elhan.

SINE to as strong selinexor Slide We compounds, with its novel and X. our accelerate Karyopharm Turning a second eltanexor. stage of growth next to quarter had we

obtained X indication foundation discuss fast-track U.S. we III supportive data, myelofibrosis advancing our based with of ongoing selinexor, strong lines. the recently shift continue a As in our we a the catalysts X earlier of multiple pivotal focused pipeline set Reshma will and upon are a over next Phase designation with into years. With studies expand of clinical and further, pivotal myeloma current approved to

discuss move total multiple Sohanya marketplace. also stream continues of expanding Selinexor U.S., globally. approximately XX to of a As global royalties approvals and indications launches the a with as year-over-year milestones for forward in providing demand further, grow from in in from XPOVIO myeloma its our will footprint outside with countries competitive us various is payments growing partners

our taken clinical of of prioritization streamline cost we structure. our late-stage continued our pipeline, to have our part and As additional operations actions optimize

Phase workforce X strength, reduced extremely this financial difficult As decision result, our impact our provide needed to is on to and III our expected shareholders. capital the was value maximize by given deliver has studies employees. we a for our on enhance us XX%, which direct have the with This our approximately an

the focus moving opportunities forward. enable us. careful tireless am consideration, who sincerely are will Karyopharm's work and was this being in near-term the the further However, for the commitment organization order that colleagues of colleagues to after grateful ahead success imperative all I to of and on impacted action

the Phase the given potential to our in XXXX was timing As ongoing data, ASCO second-line would expect XXXX. In momentarily. Reshma transform the overview to accelerate multiple we which we of data treatment we here patients, Slide Plenary an myeloma. the speak A organization Series unprecedented upcoming endometrial selinexor endometrial of second to into continued potential presented selinexor cancer an what half move the our Phase successful roughly enable myeloma. believe is with cancer, growth key has SPd which week represent clinical III presented opportunity successful, incredibly annual peak to anticipated and treatment year X, revenues. Starting the trial growth of in next with will billion the in meaningful readouts, with last multiple paradigm for and if of deliver of the III TPXX Each for virtual $X trials, at wild-type in the

commercialization achieve with capabilities. Shifting Finally, we Slide X established announced upon our believe we as we responses the we multiple seen to over the position our X recently next myelofibrosis, late-stage proven thus of treatment X. Phase the III for build growth, the transform we and we frontline leveraging years deep product sustained approvals potential rapid, Selinexor's far. the our Collectively, in development to phase of have the initiation to with on and pivotal to deliver as and have potential patients next myelofibrosis internationally

Our need expansion provides selinexor to global continued launch with further global opportunities to in patients with treat our partners partners and our additional as commercialize in continue territories.

growing Our with and double-digit future up payments license royalties of $XXX through partners milestone a sales and potential us to million. agreements stream our development revenues of steady provides with

Moving I like to would turn pipeline further our to call over on expand to progress. Reshma to Slide clinical Reshma? X. now the

Reshma Rangwala

by indications I Slide pipeline need. advancing which you, in enrolling III on Phase high our Thank Richard. are X, with want to of that highlighting start includes multiple X selinexor trials off rapidly pivotal unmet

SINE our eltanexor, we in second compound, neoplasms. are addition, In myelodysplastic evaluating

patient dexamethasone with lead Upon with Slide an selinexor, the is and with of consisting of ongoing dexamethasone. with myeloma of potential survival. regimen III United multiple as this landscape their cell combination pomalidomide T recurrent in evaluating an current endpoint with advanced and Slide disease the myeloma. On population form dose combination The relapsed/refractory is the approval multiple common with X-year that we antibody regimen and observed in of Patients dexamethasone. only franchise for most anti-CDXX randomized primary is are myeloma progression-free cancer trial of pomalidomide The have milligrams the a in on received XX%. pomalidomide important elotuzumab this patients gynecologic multiple backbone sparing well-established are therapy chemotherapy, the our of at progression. and oral the XX, seen recent Phase to or are patients who of selinexor the and low States therapy taxane. expanding endometrial potentially could all-oral, XX X:X improvement, is relapsed/refractory only given until needs XX, approach to platinum clearly cancer treatment survival primarily This chemotherapy completion first-line rate that most As

types, other a As meaningfully has established to therapy selinexor these benefit believe is selinexor cancer potential for patients option well maintenance patients. and administered offer in maintenance improve overall TPXX is orally wild-type the clinical and in the we

or ratio in of months the hazard months. molecular demonstrate that the on treated the selinexor those seen their the type TPXX exploratory and achieved SIENDO of potential EC-XXX representing States, potential stable, microsatellite Patients wild-type instability upon or assessment PFS TPXX now treatment on robust pXX isolated recurrent receiving microsatellite women XX subgroup, of These tumors endometrial mutant As XX,XXX ASCO Phase Within placebo. reinforces classification, including whose data cancer XX, showed wild Slide trial for XX virtual SIENDO is at MSI of from that maintenance status. TPXX XX% trial, data or are seen XX.X which be evaluated subgroup is patients a current disease to the progression tumors median of the from follow-up the XX% Slide on July type individual selinexor With the the the with ongoing clinical cancer The aberrant patients based XX% a prespecified XX. Series the for this advanced diagnosed demonstrated a benefit or decrease biomarker. are follow-up long-term The for X.X in X.X and approximately as and microsatellite TPXX United arm tumors as with roughly median type. wild months recurrent in XX% of will median compared selinexor or Of Plenary recently the classified be are either TPXX III X.XX, the to the subgroup PFS endometrial advanced is only death. with follow-up ultimately subgroup, or selinexor whose months exploratory risk are and patients' trial. Long-term wild is a has patients data confidence MSS, high. TPXX to are wild-type presented the analysis instable, and observed in our rationale from therapy,

wild-type As XX, TPXX patients by we further status, given endometrial with were endometrial this cancer instability cancer. turn importance growing diagnostic marker of to microsatellite classified Slide the in

signal seen in While a instability in are potential of a is status, notable PFS of that high. or of clinical inhibitors, disease risk the in PFS observed corresponding been to minority type that the progression and has to is whose decrease of median patients in XX% a the not pXX X.XX, those continue hazard the wild improvements were ratio patients evolving is death, MSI most reached observed MSS. regardless important, the data given disease disease whose data which of show These benefit greatest the is checkpoint microsatellite

mutant Slide patients a similar events and wild-type overall nausea, The adverse subgroup emergent emergent as TPXX were events selinexor aberrant. treatment or and adverse seen diarrhea. were were maintenance events on and therapy. common vomiting being seen that the manageable whose treatment Grade X/X the adverse most believe XX, AE with either thrombocytopenia. incidence As emergent generally the were Grade events treatment No And generally neutropenia, nausea Treatment profile is TPXX we were exploratory emergent rare common tumors the of observed. X most in adverse of severity in subgroup

Turning to Slide XX.

treatment The first-line pXX endometrial data trials signal cancer, death see disease checkpoint endometrial in X-fold we increase Given observed cancer of approximately the compared the TPXX efficacy exploratory especially or the given transform time progression we cancer, for wild-type of light the subgroup in inhibitors. data in in the paradigm MSS the notable of is wild-type placebo. an to of opportunity evaluating the to endometrial to

benefit treatment evaluated of demonstrate in inhibitors some and they is both efficacy patients whose MSI maintenance While is that of those those overwhelming settings, observed the high. disease checkpoint the in trials largely the

testing approval study's wild-type the European III primary molecular the and time endpoint women and disease enable the same details opportunities XXX treatment do be placebo. cancer. cancer the our selinexor occur of survival. for tumors will Network we endometrial whose at in this Gynecological endometrial wild with dostarlimab collaboration of the these Foundation for to approximately Oncological recent The Gynecology the randomized Medicine's identify combination not of endpoint achieve manner patients of whose pivotal as diagnosis overall selinexor chemotherapy approval XX% key cancer GOG, of Trial with milligrams of Phase advanced at women. On selinexor sequence next-generation for either is early of test enrolling wild-type companion and as tissue-based pXX patients that MSS, as study X:X approved. The therapies of is approval the anticipate patients Ultimately, light recurrent administered are and group, high, between of with in XX disease XX, Group. in trial as anticipate companion the in a weekly the Patients will is diagnostic, majority of Given is or Oncology monotherapy MSS a degree EC-XXX Karyopharm a diagnostic TPXX secondary pending in to utilizes that highlights are same if This with benefit a first-line The of to transform survival or development Slide a receive ENGOT, selinexor, we study the evaluating the TPXX would whose patients progression-free novel MSI once endometrial selinexor. classified immunotherapies, enroll in these actively and dose study, type. women's a importance our successful a

line XXXX. event-driven we top an anticipate to trial, XXXX early is this in that data currently late Given readout

Turning our on attention now Slide XX. to myelofibrosis

see designation the excited of to on with start granted for designation at of men with of new given and trial patients limited SVRXX presented frontline TSSXX. updated therapies our the of with announce selinexor. need data approximately that XXXX, combination achieved and study, XX%. at week the Phase occurred patients current low EHA of is can in on with patients the conferences selinexor rate be as XX% dose SVRXX Furthermore, I selinexor We FDA standard week treatment-naive patients for In in than see these an XX, that with table, of XX% was selinexor We and XX% in which in ruxolitinib, XX% ruxolitinib and lower such only I has dose This high those treatment XX-milligram XX. and XX. On of SVRXX with efficacy June design rapidly less the Furthermore, patients. care can observed and ASCO Slide unmet the action, myelofibrosis. you myelofibrosis the XX. evaluating the XX, mechanisms you ITT emphasizes the fast-track even Phase low In of are week seen XX is TSSXX the to Slide population, efficacy a achieving week novel results at a reductions who rate TSSXX observed the of achieving SVRXX At of a of subgroups can was recently that myelofibrosis. with the SVRXX at

symptomatic, our benefit in as patients early The myelofibrosis with was study, sustained as JAK-naive The well, ruxolitinib and be potential achieving in with approximately JAK-naive that may you high-risk deep randomized patients selinexor trial see week results XXX as with plus myelofibrosis in rapid on Here Phase rapid, selinexor patients. combination ongoing in enroll of achieve. These symptoms XX, X:X XX. a ruxolitinib substantially as improvement that ruxolitinib efficacy We TSSXX initiated underscore the and Slide our or plus will XX% Patients anticipate placebo. improved June. XXXX. on data to line will top intermediate conviction seen III observed

therapy subgroup of important as Phase who the to planning monotherapy pacritinib ASCO count and ruxolitinib at either embed to options is event XXX,XXX. performance we the and review will observed. Phase selinexor week selinexor This EHA, commercial data patients with patients week trial, suboptimal presented to investigators JAK-naive platelet as ruxolitinib, XX,XXX This need high Slide with on a baseline are patient for quarter. to will for treatment-naive at limited receive our in coupled a add myelofibrosis. With it between to as to over transform trial that, the now for I population uniquely please selinexor a has ongoing allow are XX XX suboptimal XX. unmet backbone hand available. a a the of treatment evaluating or turn Given in a in Sohanya responses of myelofibrosis with or III, initiate doses trial II patients to the This And potential treatment

Sohanya Cheng

contributing grew and the in you, a I growth competitive in setting, have the we by Slide show XPOVIO's this where XX, marketplace. our Reshma, of of community am continued demand performance, second to good our to XPOVIO in Thank present to with of X% year-over-year made quarter progress morning, pleased XPOVIO in everyone. On total to strategy total revenues year-over-year line quarter. the In XX% in expand in use demand setting, second about X/X

myeloma contribution already and to XXXX, for time Assistance of X% of million PAP continues revenue a a our of open although amounted and X% support multiple X impact result patients patients foundations unable closures financial comparison, total qualified in many elsewhere. was cumulative to medicine QX see provide to the of driven total Program, patients. QX late and in demand setting, X% to QX the Medicare use we were a continued Patient total beginning reduction of We PAP the was continued open. pre to which was by for remain second to also financial of a XX% XXXX. growth cell to to the achieved impact. which get of year-over-year impacted carryforward, This main of QX in provides Patient be the third-party In continue multiple free quarter, Program, support allowed of earlier demand the foundations or This utilization year. PAP adversely T in refill patients roughly demand In higher new XPOVIO XXXX academic period revenue of our Assistance to post $X of that contributed in X by who therapies. Net entering in PAP, myeloma

XXXX, Moving forward less Medicare the burden the assistance. IRA-related for significantly Medicare utilize requirement, of beneficiary Part to D in X% and coinsurance the will design eliminate in changes need expect D copay patients Part patient of carryforward for we

demand second to the fourth-line XPOVIO, the XX% also compared the Medicaid shifting QX XXXB in Medicare of in discounts. Despite quarter, headwinds as share marketplace, growing Additionally, in pleased have made net as net year-over-year for patient but only lines. XX% gross higher XPOVIO year. to by we well revenue surpassed in see was the last QX into earlier not by increased are in we new XXXX, driven X% progress to rebates to In total impacted in and second

therapy. in million $XXX intent Our an reaffirm improvement continues guidance on million of data earlier extend $XXX use, time to prescribe to which to to potential showed optimal more U.S. in and support in experience net XPOVIO XXXX. the third-line patients a our have We for lines revenue

believe convenient a or an in an as to XX. therapy class easily as be we're T we multiple may optimal Let's treat anti-CDXX fourth-line hospital novel tend patients XPOVIO X rurally elderly therapy effective, optimal pre combinable therapy manageable, to a strongly be second also or now a community where post in with we XPOVIO second to accessing of Amidst setting, therapies. novel as line to In earlier in and of the setting, fourth a of oral evolving of populations. a treatments is It distinct patient landscape, an the advantage burden cell of that post treated, Slide action mechanism the to logistical is academic myeloma turn the the for the used positioned line patients. believe has based decreasing therapy. therapy class In novel an

approved. study, of of myeloma by the is pomalidomide to growth if with fourth over the of revenues franchise. turn marketplace, to our therapy the in and partner U.S. could we're generating therapy dose we pomalidomide only our at an in billion As potential line, commonly used In future dexamethasone in anti-CDXX following second lower $X a encouraged lead The SPd all-oral in milligrams combination the the the XX selinexor to Slide the of XX, triplet regimen backbone

make potential by characteristics SPd to approved. Shifting on to significant up these unlocking Given XX. of value the patients that we the encouraged with cancer in are myeloma, endometrial Slide if opportunity combination, the multiple

key need by for to are potential a unmet selinexor in molecular the significant We encouraged address subgroups.

As we treatment leaders including the see wild-type in a in unmet tumors. with engage molecular it unique that need key clear is TPXX space, for subgroups, targeted opinion this they

a wild frontline treatment rapidly, the unmet emerging subgroup. are options in pXX need specifically remains While type and clear MSS

most over market, the that U.S. endometrial in which U.S. at look XX,XXX or pXX large XX% the are in patients in X,XXX commonly endometrial about the with and this we over of As the is cancer, cancer gynecological potential -- advanced cancer common wild-type MSS have opportunity patients. wild-type globally pXX recurrent

very encouraged by a opportunity are need women safe more who selinexor's and to targeted treatment effective, option. help We

selinexor as convenience that a Given therapy, is maintenance a is evaluated being critical factor.

oral clinic for visits. therapy, eliminating treatment duration need by we an maximize the frequent As

Turning to Slide now XX.

in you drug myelofibrosis. XPOX transform treatment frontline As are inhibition classes front heard from the There to paradigm JAK other has inhibitors approved in no opportunity than Reshma, the the other line.

at As high-risk globally U.S. intermediate XX,XXX the over the opportunity patients in are are that to patients in there myelofibrosis. we and potential X,XXX the market, look myelofibrosis over

selinexor's frontline the ruxolitinib encouraged of willing about care, to to on We are were market efficacy. by replacing monotherapy transform standard due better as opportunity of healthcare to very research, providers myelofibrosis therapies treatment combination third-party potential of adopt XX% paradigm. Based

on ruxolitinib profile. that is there preferred in frontline a TSSXX approximately plus promising SVRXX strong selinexor efficacy and they ruxolitinib, rates select healthcare therapy, based Additionally, around XX% if providers as their safety approved, combination indicating initial of perception combination with a manageable and selinexor would with

by and over us. Please our strong multiple As has to opportunity business call build I'll a his X launches remarks, advance now Slide Richard continuing on with tremendous our commercial to Mike. ahead XX, discussed the and to Karyopharm team for turn opening potential of base myeloma leveraging growth in

Michael Mason

Sohanya. you, Thank

to have to our XX, including ongoing a These III X with and Slide representing strengthen optimized Phase on market reduced with our at workforce needs. large further addressable Looking our further Phase focus structure cost unmet invest steps pivotal in resources we financial XX%, each our our III studies approximately by position patient trials contractors.

and capital needed Richard Finally, X maximize mentioned, to our we the on value Phase have shareholders. III deliver for studies as

Slide for product Total $XX the million the will was of quarter's I million on for Now second focus highlights. sales of the to quarter XXXX. XX, quarter commercial of financial XXXX. of for $XX.X compared on million revenue to Net the for the $XX.X XXXX of from second million $XX.X second XXXX U.S. second XPOVIO quarter compared revenue quarter was

Patient As XXXX by Sohanya in of continued as Gross as discussed, Assistance net of our second compared more net in the revenue discounts. to were to XX% to be well as discounts the adversely to net product XX% gross quarter higher affected patients Program second quarter XXXX. using

expenses our a the XXXX. management, costs. Turning With our be in delivering year-over-year to are we continued first cost and pleased reduction focus XX% on to in combined R&D half of SG&A

finally, product for million revenue in guidance in guidance million now of million. SG&A U.S. initial cash of from and are revenue XXXX for our on to compared We February. And of full expense expenses, of of second second for non-GAAP we of we initiatives, anticipate full recognize million expenses for our reduction lowering XXXX. our the to efforts million XPOVIO expenses follows: $XXX $XX.X our the $XXX plans, reaffirming restricted guidance. the to to million, of $XX.X the and down of our excludes R&D XXXX, be our for stock-based benefits which our December $XXX from of at coming $XXX.X are equivalents, $XXX $XX.X expense, cost of compensation range $XX.X previous million $XXX.X were SG&A R&D X% XXXX. XXXX XXXX pipeline, revenue of current in quarter reduced million to XXXX. Cash, as the XXXX XX, totaled second range net quarter cash our million in to as total million million year million; XX, focus to quarter the As operating year compared Likewise, for the we investments compared cost to by $XXX quarter the million have June to $XXX and second we to as guidance With XX% XXXX. Based down cash the million $XXX $XXX

with our to XX, entered have We amount to X.XX and XXXX, months X affiliates from into extending date amount payment XX, Healthcare payment Partners, X.XX. XXXX, agreement June an Royalty of interest from revenue our December financing aggregate cap increasing amendment the to by

existing together, other some of investments and sales cash revenue the as Slide XPOVIO operations bonds our be maturity Richard? equivalents to generate product October excluding in XXXX. I'll end Richard fund will cash, expect as well our for Taken XX to to the through license revenues and final turn the XXXX, we sufficient and from planned thoughts. now of our convertible

Richard Paulson

Mike. you, Thank

to Turning Slide XX.

are to As needs. Thank to our for to are the X call. continue strive unmet we discussed investments stakeholders. up to would through near- today's today, you us like and value patients and each Phase now joining pipeline, have date, again all of ask thank our with our for who advancing concentrating day create operator to III Operator? out to and and to as high execute we the the that who I I manner in work XXXX read like call to Q&A teams long-term portion in disciplined XXXX a would we open programs rapidly for expected our

Operator

[Operator from Peter Instructions] Our comes Barclays. question first from Lawson

Unknown Analyst

[ is Peter. Shay This for ] on

drug more I an around also XQ. through maybe So a first, color free the was believe just wanted this program. get impact PAP little to in

compared XXXX? this remainder is for how the how out of XQ So dynamic and provide you any around just this see playing to you could color

Richard Paulson

to to the I'll that, Assistance Maybe Program to of for Patient Thanks, QX drug how Sohanya turn lay free QX. from and kind evolved has Shay. out

Sohanya?

Sohanya Cheng

question. for Thanks the

foundation helped a a reduction but of So in for X terms the of foundations main in in in myeloma for QX, refill allow time impact which PAP, patient entering in starts continued open X the period PAP. saw multiple QX, was new to of we

PAP XX% QX in contribution was was to with QX compared X%. total demand So in

it QX historic was normals, year you X%. If at compare it with last of

million. the PAP revenue roughly closures loss So from was to in $X net total alone QX impact foundation due

the QX, foundation and open we QX one As partly about currently, continues was think that to to in QX date. open remain

sight largely have range these disseminated, how impact also foundation around this we factors uncertainty due closures. guidance several but PAP are but GTN like line of into Now no control incorporate or does our impact, to funds the

Unknown Analyst

refinements. around the just final quick is And maybe some cost a question of

program So I cuttings there be anything Any later workforce has refinements kind team year? a other know of there's in this there the that in been terms cost whether about? be the should kinds reduction about we Is of of quarter. thinking may thinking

Richard Paulson

Yes. Shay. Thanks,

I think optimizing cost on to we ongoing kind we're as our highlighted, basis an continue structure. focusing we've make and of sure

So how obviously, and our multiple capital. myeloma, And basis, to obviously diligent our we've on in ensure continue investments in ensure Phase to allocating our XX% ongoing focused III reduction with an workforce our myelofibrosis. do in quarter X endometrial that we approximately programs to we're cancer the evaluate costs really with continued being this we're deliver to on able to we're our being really

Operator

from next Jefferies. Our Raycroft Maury from comes question

Kevin Strang

on Maury. Kevin is for This

you patients also, to study for prespecified endometrial, with and within there you MSS pXX look was Just that in at for then line PD-Xs? could patient population? shift the for competition will powering as wild-type high MSI whether about the and the could time talk readout, the due the that you say whether subgroups And

Richard Paulson

it Reshma talk EC-XXX and our Thanks, focus and Yes. trial. kind Kevin. all endometrial turn I'll put advance in the that the we about cancer as progress to to of together

Reshma Rangwala

Reshma. Kevin, this is

So thanks for the question.

a of modification XXXX. In of slight lines, XXXX, there's the end from beginning terms late of time

this course, event-driven trial. is an Of

most TPXX the the beginning occur, In that how PFS wild-type closely progression-free initially for this at those median months. we presented looking in Slomovitz the to ASCO recent that back in XX.X see to disclosed events our perform trigger With Brian XX.X the update we last ability that of evolve months year Plenary, see the that now now survival. from patients when So the positively at actually the will we're said, evolving. analysis we data is

late anticipate, XXXX more a reprojected have median fast we and at those into or We're in approximately So that PFS accrue. spread. how probably of beginning a than events PFS, is XXXX. month events couple that a on looking those to either again, that Taking impact account, doubling occur going to slight

pXX that of majority wild-type Obviously, largely looking the question. the Phase it's the subgroup, whether a vast In a specifically unprecedented. comprise data subgroup truly because wild-type wild-type we MSS, MSS/MSI. And that observed is are subgroup, that in very all great III does the terms is again, it's pXX and EC-XXX on believe subgroup, in encouraging which that data designed, of at the trial, novel of The way specifically regardless is this pXX the patients. that focused

the looking will subgroup is on patient wild-type course, or MSS and at right But population, be pXX are truly of pXX now, should focus that large patients Of wild-type we subgroup pXX I MSI. wild-type our separately who say.

Kevin Strang

talk able how the a they a another also fall. of you be to And score you size top view you on That just There's lot Great. myelofibrosis. symptom III in on Phase but about not just treatment this We makes Phase that update sig succeed saw competitors line your spleen coprimary follow-up evolving expected data, recently one III? hit showing of data score. here? Could gives what then confidence symptom the then And on that your sense. landscape stat you'll

Reshma Rangwala

Yes. Yes.

we me, intriguing data trial I'm additional arm probably at COMFORT an lower very me presented years in any performed. that that surprising up, beyond too. actually saw benefit the a I how is to than XX%, what So found in It was Phase saw that we that more privy specifically milligrams not right, approximately from you release, well. data I what lower saw the assessing ruxolitinib than rate was data my confidence selinexor XX actually I of spleen trial, the as What When what SVR which important ago. goes that XX%. It the XX suggests little press ruxolitinib, to the at is with having ruxolitinib analyzed is to volume expected. look combination that on our reduction, really fact than given that

meaningful suggests on percent in we have So compared ongoing that III benefit can spleen study. to our that XX% very XX-ish that really Phase reduction volume a

a so TSSXX, the of certain that terms I'm surprised. In not to degree,

at marginal that Phase is transform II So their my best. was from understanding the trials TSSXX earlier

patients later toxicity, say, lot form, aspects to in out why can we this need to suggest which saw. that in of contribute of Hard we hit analyze that go is XXs, as TSSXX going compared on and the mature look marginal? know AbbVie year. so enrolled our I'm, more an even of is that it which TSSXX rux data that missing by data trial. combination next well SVR Now important opportunity the including their scores, both TSSXXs I. very the alone, to Phase completing TSS it as as TSSXX, encouraged again, this ruxolitinib right? We data obtained are the part to of Again, low does patients XX% their the maybe that Obviously, at to beginning that to to a I III of data. And and Phase meaningfully to really selinexor report endpoints can not data both back as had improve in our plus data continue part year, hopefully we from

Operator

comes Colleen question Kusy from next Baird. Our from

Colleen Hanley

increase PFS endometrial context So that you what ASCO therapy been? of share SIENDO versus in duration to think presentation cancer. the market placebo. on you an the trying has to Can the average in in Plenary, about continued opportunity for in see Just the time from

Reshma Rangwala

the Appreciate question, Yes. Colleen.

presentation those next the median we'll XX don't PFS still duration months. actually duration median data to reported on an track maturing. at and have treatment treatment that So only We duration present yet, still treatment continue in we the X:X. to it's know We haven't opportunity of data because have upcoming And X as do that of likely median are an of on treatment. patients to that mature, and

seeing an trend. interesting are we However,

we're median seeing median get duration also that longer, treatment as also of longer. gets PFS So

meaningful So that but survival very on evolution from is I both think a therapy a progression-free as well. time

Colleen Hanley

centers That's do and think myelofibrosis fast patients? you'd and Phase you up target the III it myelofibrosis I helpful. on but many there. is the And naive for track study? And it's know then early, find challenging running congrats how this how getting study status to

Reshma Rangwala

Yes.

a a the been So right? think, this We've many are we've yes, encouraged very combination behind milestone our lot but important with investigators again, able initiated. of TSSXX, to evaluating in momentum aggregate to trial, that by I that a present reduction Phase those trial the potential and from data get very got in III I monotherapy. of that again, that this disease ruxolitinib, aspects spleen positive having selinexor volume is that the only combination not modification Phase key really suggest

So it's myelofibrosis. this are holistic profile a be game can that really treatment-naive suggests that this combination for who changer patients

III be By global is large, In there and no going trial. trials. none, So to large terms this there's of a right? is well, competition, Phase other

approximately are in as really looking as We're And competition Asia. U.S., Europe for no activating the myelofibrosis throughout patients are globe. again, sites We well XXX treatment-naive diagnosed sites. at there's those that the

really So all enthusiasm, we're and lack of from of headwinds encouraged by the investigators. just strong competitive support our the

Colleen Hanley

last us. And great. one That's from

you look about can about just the study at? and myelofibrosis on talk picked you call, rationale population talked you the to monotherapy that the why On patient

Reshma Rangwala

Yes.

the it's really this finding So upon this intriguing seen largely we're for us, we've trial innovative design Phase finding really was and from a -- based I study.

doses subgroup treated suboptimal that we're and has mechanism don't who with alone SVRXX that fundamental is you in important potentially see ruxolitinib patients ruxolitinib, achieving and finding TSSXX. really are of that monotherapy Specifically were that of activity. patients a Again, that still XPOX selinexor suggests with

platelet XX that a patients investigate trial allows at in to trial milligram platelet and us are going achieve to have that this hypothesis. How So milligram or conducted myelofibrosis, large, treatment are to be these that have an response this is who XXX,XXX, who are with And they they to going XX,XXX we with baseline at still we on despite therapies to are are counts ruxolitinib. TSSXX are really pacritinib add therapies the patients By limited between Why therapies, ruxolitinib, have marginal. them and that options. pacritinib to population? this or these looking either quite only available XXX,XXX and and very know selinexor, doses. treated XX,XXX Because of monotherapy be whose SVR better treatment-naive opportunity then suboptimal event the their XX the selinexor baseline to either be going specifically, counts patient to and is

So it's these and potential combinations, to novel assess opportunity monotherapy an selinexor too.

Operator

comes from our Instructions] next Piper [Operator Raymond Chris Sandler. from And question

Nicole Gabreski

Nicole on is Chris. for This Gabreski

around So survival endometrial. overall maybe just in

secondary a SIENDO during up I topic of as was a kind Plenary ASCO endpoint of discussion trial, know the the came in session. and that So

the disclose I if guess in quickly the focused wondering the should you maybe about programs, just late-stage how how we guys was future. the then to just and you're should about eltanexor that any OS point for program. your just And prioritization and I So think of on trial data but eltanexor. this path we for are from expect you thinking I know just MDS at forward wondering

Richard Paulson

Yes. Nicole. Nicole. Thanks, Thanks,

turn us I I'll the continue I the to think eltanexor, see as bring over obviously Reshma maybe next And trial, which looking endometrial SIENDO XX think data has report talk as we OS. we benefit to is X indicated, of on in the potential to of know to cancer maturity the we'll the we about I important out kind as Reshma months, Reshma? at move forward to patients. very can for and continue

Reshma Rangwala

Nicole. Thanks, Yes.

few that Very II. high-risk we next specifically MDS patient have specifically eltanexor. opportunity encouraged myelodysplastic really syndrome reported So this X data the eltanexor plan core We'll by our eltanexor with development X to the an of neoplasms, define with optimal relapsed/refractory population. Phase evaluating We're the months in specifically that is from in programs.

Operator

The next question Abrahams comes Capital RBC Markets. from from Brian

Unknown Analyst

on Brian. This Joe for is

just continue mentioned benefits show encouraging. know very continue there, With And just I seem the going therapy I'd the follow-up to that that to to remain on endometrial cancer. too. back to patients ask, and The PFS some data clinical continue you

just approval far? the this So for And you have discussed top expedited any early late in line if or that something with XXXX. reads FDA the there's before XXXX is were -- pathway out wondering so

Reshma Rangwala

Yes. Thanks, Joe.

a compared as is our type. us that in both evaluating drug we to diagnostic pXX of well-designed as in a prospectively remains to assess with companion the as FDA. With in the that as placebo. the get our form trial comment So assess survival we the selinexor in U.S. well NGS survival allow well pXX would important to approval the we are ex-U.S., don't progression-free interactions It's as on patients specifically too. and our platform who that opportunity the which that said, study wild overall EC-XXX are opportunity well-powered EC-XXX

evolving in our encouraged our So we data that those confidence observed trial. the from quite nicely. informing on though, -- likely design very remain outcome our we've remain that We from SIENDO that data the focused much only SIENDO, is and is of EC-XXX trial really that EC-XXX. informed increase

Operator

JPMorgan. question next Our Joseph from comes from Eric

Unknown Analyst

on Eric. Noah [ is ] for This

it of what for generous EC-XXX anticipated arm the your in to median group regards powering wild-type the your in similar is readout? guidance study? is that or SIENDO in Just pXX more assumptions And for than placebo in PFS the study, the

Reshma Rangwala

Yes.

So great question.

months. XX%. It are nicely, So at continues PFS we're that the of is those a quite for disclosed going kinds haven't powered, excess we With beginning the on in data is that XX.X that in well increase assuming confident of be said, initial that those median we trials XXXX, Phase that well to the selinexor we were that So data the -- months, fact exceeding are Again, details. given of again, III above of PFS median to observed that median PFS quite our the of time XX.X right? the cut. all

PFS, PFS the we're we're time the at XXXX, very read that end of to to again, selinexor very in anticipated confident see going that compared treated with able meaningful So XXXX, out a of beginning the that patients to placebo. improvement

Operator

next Partners. comes The Chang Leerink Jonathan from from question

Matthew Cowper

Jonathan. Matt is This on for Cowper

enthusiasm rux given in potential regulatory and your does only the mentioned development You impact that how there are approvals some I there, certainly data was and the against it's with and treatment-naive combination impressive. the XPOVIO/rux for just combo monotherapy? upcoming trial the interactions around wondering, myelofibrosis, was readouts

Reshma Rangwala

need and any anticipate of out readouts, right? Yes. the are just We companies to regulatory Data be that enrolled completion either regulatory go through both the don't time reads to data almost close enrollment line for really TSSXX. to or the approval impact are SVR We positive is Obviously, the -- process. that assuming by kind again, trial those the with our data obtained, anticipate results. top of extensive enrollment

not III only trial. Phase but design So in our again, the of data, the we're in very confident

Operator

the conference over Richard for turn like would to remarks. back any our concludes I to Paulson closing session. question-and-answer This

Richard Paulson

operator, you, call thank today. and Thank for joining everyone, you, our

we novel eltanexor. our each manner, selinexor growth very a a As compounds, its with beginning to needs. quarter next disciplined at SINE And the Karyopharm And execute striving once the joining unmet very thank for again, to you, today. patients thank continue of had as and we teams I call, high indicated for day both I'd strong with the second accelerate in who to like of call our stage everyone,

Operator

presentation. today's has conference Thank now attending you for The concluded.

disconnect. You may now

Karyopharm Therapeutics (KPTI) 2 Aug 232023 Q2 Earnings call transcript