KPTI - Earnings call transcript Q2 2024 | Karyopharm Therapeutics Inc.

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

Operator

Good morning. My name is Carolyn, and I will be your conference operator today. At this time, I would like to welcome everyone to Karyopharm Therapeutics Second Quarter 2024 Financial Results Conference Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. to President, call Investor like Webb, to now Vice Senior Relations. would turn over the Elhan I

Elhan Webb

are Thank our you, Second with release, Carolyn, We our us I Financial on financial and that and a issued thank call you conference Results website. reference available QX this will to slide all a call results press on presentation discuss morning company for our along Karyopharm's recent Quarter today release XXXX today's QX during progress. for detailing joining This XXXX.

today's as by our recent Mike an For call, X, and seen I'm on Richard, will on joined update results Slide XXXX developments. and for QX Reshma, Sohanya clinical provide

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

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

Richard Paulson

today QX for morning. Good us Earnings thank for you, all XXXX Karyopharm's Call. Elhan, and joining you Thank

regarding myelofibrosis, reinforces exceeds as when In whose XX our late-stage X. ASCO, of our the data role continuing to pipeline approximately work and advancing patients to next growth PMMR. a SELINEXOR in our population we SELINEXOR's for of cancer. used strategy III that we TPXX represents It preclinical survival at and nearly are by strong deliver overall study with endometrial presented subgroup is wild are foundation in Physician this Building at stage maintenance our who achieved half indication. continues evolve the all are therapy clinical SELINEXOR like myelofibrosis. is on EHA setting maintenance is in the to focus favorably demonstrating the with survival in progression-free multiple in This noteworthy on to innovation presented into ever strong more strengthen than would first as by in Turning Slide data, the excited CMMR. our Starting data type, this progression-free in that enrolling that I that potential growth of competitive in that demonstrating our to patients we might us. updated are while opportunity survival checkpoint the environment Phase is myeloma. patients interest play we further new SELINEXOR cancer, tumors months inhibitors endometrial whose is diagnosed the tumors patients

will proactive we actions, maintenance trial to Reshma Phase trial targeted are molecularly our of continue complexities both patients III in confronting expand which cancer, we enroll in the As a on. EC-XXX endometrial also of and are taking

expect we line early to now a data As result, in top XXXX. deliver

Sohanya will mechanism administration of and impact cell giving in all resonating we XPOVIO action, which consecutive quarter pleased to increasingly sparing XXXX. T revenue, of of low and to our community of our its guidance expand growth XPOVIO's In multi-myeloma, report with for end oral raise on. importance confidence is us the second revenue differentiated academic are potentially physicians, The

the we fewer to trial. the include the XX-milligram on the III evolving positively to foundation enrollment and we to SPD update our of participants multi-myeloma, of for this cost work lowering dose projected will data trial, of leverage at targeting which our As design build commercial expect Phase EMNXX

Finally, in disciplined lowered R&D believe to our guidance. and light on will performance, on in we of strong cost strengthening position we're management late-stage pipeline. development, to Mike deliver expense SG&A and clinical expand commercial XXXX approach focused a prioritized financial our our

positioned well the diversely built be for on to SELINEXOR continue opportunities with indications. next pipeline growth stage and optimistic late-stage across very about of We to different our cancer are our capitalize X

for to could data turn expand recent the our programs announcements billion Reshma? believe would progress our revenue call the alone. each to discuss annual peak SELINEXOR We in over I be on our the U.S. of in and $X the with to to pipeline. opportunity like continue now Reshma

Reshma Rangwala

Thank you, Richard.

enable to either pipeline like milligrams. to the X. X Turning the to our of SELINEXOR's Slide by led of or and I'd doses highlight a data of continuing promising standard has the XX build growing new utilizing III to lower body XX studies, care, potential each late-stage of which Phase once-weekly upon ongoing

to with presented X analysis I'll pivotal to Slide trial expand by III supporting exploratory the follow-up continue including that date which the myelofibrosis be very Phase from was in Starting X. at our trials, shortly. cancer in We on long-term ASCO, encouraged subgroup the generated endometrial data the on data improving SIENDO

June, to its excited our Hybrid These non-JAK myelofibrosis the data the Association incredibly JAK of new preclinical both in in at Hematology the both our In area. are data demonstrated work evolving inhibition data strong pathways. rationale and and Congress. ability target European in by we and interest this presented mechanistic We XPOX physician

JAK achieved pathways, in and efficacy ruxolitinib Of inhibitor data XX week year, aspect XX. Absolute that in that naive that with both both in we improvements monotherapy. shows Slide dose believe of trial combination durability reduction and was be deeper can meaningful XX. respectively. XPOX the We population. XX, demonstrated leveraged into In our JAK of important the on evaluated Diving on selinexor data a and received a evaluable SELINEXOR of very from week XX seen and in I inhibits as myelofibrosis XX-milligram Phase TSSXX as light combination last Slide our in milligrams non-JAK at presented who patients patients. TSS the XX.X SELINEXOR, at average the XX points SVRXX of an XX% XX% with

respectively, follow-up SVRXX data XXX% As XX in of the SELINEXOR These to the probability there combination Phase of the as XX that the indicating and cutoff, a both milligrams symptom median with maintained TSSXX was than support was ruxolitinib in weeks potential duration of findings continuing used weeks, over of ruxolitinib greater demonstrate. alone ongoing the well XX responses combination study beyond may improvement when XX plus and weeks. ruxolitinib III our of responses offer are SELINEXOR of

Moving the design with ruxolitinib ruxolitinib our JAK-naive compared XXX to myelofibrosis in milligrams trial to SENTRY outlined we Slide III evaluating trial, for XX SELINEXOR Phase alone the patients. of XX, combination

strong positive We by we SELINEXOR's feedback into are trial investigators clinical unique III hearing that encouraged Phase mechanism our given are the regarding by and profile. from enrollment the clinical trial, clinical

also is activity by momentum [indiscernible] effective as therapies. and Our clinical competitive fueled minimal

half track results remains reporting of guidance for second the on line top for XXXX. firmly Our

on our to Turning Slide cancer XX. endometrial attention

export novel of what ultimately drives dependent increased pXX arrest role mechanism Advanced including important tumors accumulation most SELINEXOR's We of of suppress for DNA The PXX United the activity for is Clinically, from of could to cancer upon the repair, cancer. an leads in apoptosis. this with form patients to the is and SELINEXOR oral play greater nucleus antitumor impaired One cytoplasm. patients in diagnosed primary the gynecologic is year. the TPXX endometrial half therapy in nucleus tumors. pXX, to cancer mechanisms cell-cycle endometrial approximately these recurrent patients the with wild-type maintenance believe in than of first common the XX,XXX States as each

wild-type recently regardless As an the seen TPXX role inhibitor evolving and with Checkpoint landscape by chemotherapy, improved of by in inhibitors FDA combination emerging endometrial recurrent status MMR advanced patients status. cancer on the in Slide followed were maintenance for XX, checkpoint recurrent cancer. advanced endometrial of has

is of for both observed roughly March XX% rationale and combination inhibitor cancer regardless for the tumors. DMMR are the patients. the are inhibitors of the patients in whose checkpoint whose PMMR DMMR represent of in chemotherapy, XXXX. recurrent effectiveness with mechanistic These tumors less in included all than been However, advanced efficacy Patients consistent in have inhibitor guidelines tumors PMMR status followed patients NCCN with by checkpoint markedly wild-type maintenance since pXX checkpoint endometrial in all MMR or solid

long-term in subgroup the which comparisons, evaluated SELINEXOR Turning the compared to a data SELINEXOR the hazard a placebo, of tumors maintenance median PMMR underscoring SELINEXOR Slide PFS to limitations the improvement compared promising inhibitors with in patients, achieved with with therapy. to pXX in population. analysis the in X.X wild-type ratio SELINEXOR XX. wild-type checkpoint exploratory substantial to a with XX.X patients months SELINEXOR efficacy benefit sizable achieved subgroup SIENDO provide and months median of resulting tumors, robust by ratio meaningful In SELINEXOR continued patients. pXX with in data these presented overall ASCO, Acknowledging median SIENDO, X.XX. benefit TMMR to from demonstrated of of cross-trial unique placebo, a with X.X These months and resulting of Patients of for very we PFS exploratory with a all median experienced hazard XX.X in At encouraging the PFS from in demonstrate months X.XX. potential survival achieved the exceeds follow-up

endometrial patients were provided Overall, in data we a who SELINEXOR indicated well as checkpoint majority long-term option. PMMR with in SELINEXOR SIENDO achieved -- indication, from to are benefit as with this inhibitors, study intent from could follow-up be prescribe maintenance future efficacy a patients patients. to the pXX therapy pXX of believe cancer treatment this of In U.S. survey type wild with for wild-type that whose the a approved physicians were SELINEXOR XX% tumors as

to we data common manageable from treatment that being were review dual Adverse with at trial XX. endometrial the not events the neutropenia, generally diarrhea. safety ASCO, this were also well grade, It rare were tolerated. shown of thrombocytopenia antiemetics AEs and nausea. emergent the regardless most events X-plus Slide adverse vomiting trial. of common required observed in The Let's presented nausea on were updated note and that on SIENDO SELINEXOR, is events cancer most with important as and Grade

EC-XXX mentioned, therapies screen our 'XX. III and XX, to patients Richard our screened higher-than-expected as that are export for new between number of our top also will biopsy Phase Based increasing this and increase Slide readout to trial for data lesser observations, early the has line observations enhancing degree. completion are total Based of sites the investments these rate. we failure trial. albeit additional be impacting a by to our adding enrollment, Availability is a for need on upon to pivotal time chemotherapy we to on shifting led line interval and Finally, recent evaluation expected

enthusiastic clinically Overall, extremely months, I meaningful SELINEXOR in those for with with pXX in with the PMMR outcomes endometrial especially tumors, demonstrated median nearly maintenance data continue survival to our with to be checkpoint of patients observed provide exceeds the about where overall PNMR tumors. exploratory has median XX cancer, subgroup wild-type again the for potential patients which a inhibitors PFS setting

Lastly, multiple XX. to Slide on myeloma turning

are of were XX observed the months trial. with and was XX% potential XXX and tolerable combination underscores a XX-milligram myeloma very in updated SELINEXOR arm, We to in meaningful relative XX.X dexamethasone. May of that that in MM-XXX our in very its data Selinexor SELINEXOR's milligrams patients the an promising multiple trials milligrams STOMP BOSTON the from evaluated year position with improvement in the rates to observed this with XX% profile. median of safety demonstrated in a only Oncology The encouraged in PFS pomalidomide, Nausea the results journal Frontiers landscape. and published expand milligram SELINEXOR of XX the

upon antiemetics. the dual III not the Phase ongoing Our did build data, to the and given STOMP MM-XXX potential and trial favorable already cohorts has that improve require

that an need Phase EMNXX-SPD This triplet outlined multiple pre- myeloma trial option on beneficial in Slide in myeloma III to is trial address and be can post-T-cell treatment multiple all-oral the therapies. is with designed XX. engaging to present Our unmet with patients

efficacy of the with observed and data of European leverage and with plan evolving enable versus safety the PFS the working meaningful interpretation myeloma We the positively a to network, SPD will statistical the EPD. be study, the sponsor to of analysis amend SPD-XX

III competitive increasingly Importantly, the with we a trial similar to seeing due population. a are in enrollment in Phase environment rates of same number increased global also an targeting sites an studies slowdown patient

In data. the the the to trials review approved populations data, We and III to conclusion, continue accordingly. sample number of initiated Phase commercial highlights. the large a first X of the size XXXX. strength today, of same near-term we high of myeloma. as regulatory fact, top rapidly initiated benefit planned been our In advancing in line in revised opportunities we the plans, upon the with pending half the enroll now pipeline already now in for all anticipate to approximately trials our agencies I late-stage SELINEXOR in existing cancer of have these will compelling plan of half Based by XXXX, XXXX. patient results has unmet to indications needs our Sohanya multiple increasingly enhancing multiple near turn in with will backed call presents future, potential of engage

Sohanya Cheng

position in was flexible the action. strong a morning, a XXXX. On low highlights product discuss momentum by driven the patient Consecutive In the as of million up new second the convenient have with to XPOVIO will raise increasingly I million, everyone. a led new for across first to starts execution to year million both product mechanism $XXX oral good quarter. growth end refills XPOVIO paradigm from $XXX XX, results range was as us this $X The is and net quarter by Reshma, $XX of differentiated our our to Slide and compared guidance in quarter-over-quarter in revenue you, million. second a and treatment growth and first utilized commercial continued X% net quarter, of results the revenue Thank half regimen of of our the

Overall, shorter T-cell fitness. of XPOVIO XPOVIO community use, this which therapy T was setting earlier with contributed treatment way or immediately remained than of coming line approximately first increasingly consistent Demand the second academic preserve XPOVIO, the but a half growth. we Demand the in being setting. quarter. cell a before from in institutions quarter-over-quarter in duration year mix the the to organization a consecutive more in regimen grew to net setting setting, marketplace, starts in that XPOVIO as with used stable lines T potentially therapy very increase the the after cell first competitive the academic with revenues In XX% from XX% patient community to New this has of see remained in second bridging quarter, using to new as pleased prior commercial results the in therapies the delivered highly quarter. primarily use we in by with with offset fourth the our are first of

and Korea. I'd to as approvals positive reimbursement accomplished expand quarter, shift pleased reimbursement our as outside the was we NICE, second the turn towards recommendation like continued world. Now U.S. across with focus of following milestones U.K. global In XX Slide of and to I'm the momentum regulatory expanded in with SELINEXOR the footprint from as the South our achieved well our

a franchise patients international footprint Additionally, XPOVIO rapid as pipeline. in global multiple in with dedicated and its Karyopharm's impact continued partners summary, A launches driver have for approvals commercialization as additional expand team future and number myeloma the and to profitable in a other well. business China regulatory indications continues of globally serving capability increasingly while critical our potential In remaining markets. an to funding

like to over turn our Now update the give Mike I'd financials. to call an to on

Michael Mason

Good morning, everyone, Sohanya. thank you, and

The And was Total expired Turning quarter Slide which revenue focus million XXXX the financials XXXX revenue of of for in utilization, the second driven U.S. press quarter $XX.X we Net today results, $XX.X was compared of reflecting highlights, the I of to are million release to was with second the second the as the of XX. Medicare XXXX. strong XXXB quarter for for in million This momentum for our a net second just XX% to second XPOVIO compared quarter full and XPOVIO to XXXX. gross of on XXXX. since the will increased on discount XX% financial earlier quarter for the $XX $XX.X second compared quarter product returns. by XXXX to was issued million, rebates

We year XX% the XX% full for continue XXXX. GTN to expect to

is clinical to for for SG&A of clinical partially The our reduction the for of the million ongoing to offset XXXX reported due income quarter to $XX.X Our for to expenses. expenses III second compared X attributable our $XX.X debt initiatives million on in and with by that ongoing lower R&D approximately you were connection XXXX of programs. XXXX. of in debt to million the and detail R&D XXXX expenses in pipeline XXXX. expenses by costs late-stage Phase were which in cost net expenses of extinguishment of we of of can transactions investments concluded slightly $XX second due by with a increase quarter recognized the XXXX. quarter for our onetime the the trials. financing-related million quarter May, decrease for see year-over-year noncash million the was million higher SG&A The in of driven that of million Mostly related in in were the $XX.X headcount, of $XX.X $XX.X net the quarter second gain quarter total expenses refinancing up We gains to $XX.X second primarily $XX.X appendix. compared Phase million slide second X%, to in III quarter million on a trial the second loss pivotal primarily related $X the for XXXX were compared net in second

our trials transactions into launches. 'XX expected reminder, vast 'XX, As majority readouts potential a maturities our data extended beyond our X III from and the and these well of Phase

we our tightening on by Based $XX million. investments total trial the the to restricted for of XX, range million net of and product XXXX lower $XXX.X for with operating planned Cash, lower expense to expenses remainder costs, EMN plans, expected $XXX.X for totaled December equivalents, compared our raising The XPOVIO expense $X by and the of revenue headcount. as guidance and end as our cash well both of overall continued including revenue lowering current June and operating XXXX. XXXX, in $XX XX are cash as guidance our operating XX, of reductions discipline as million million include resizing million

year, headcount beginning XX%. our have by reduced the approximately since budget of Specifically, last we

guidance Our expected as full Total as XPOVIO $XXX of be net of of million compared the to range million. year follows: $XXX $XXX million. $XXX million updated the to $XXX for $XXX revenue the guidance to million million expected XXXX to in previous to be are ranges product of million to guidance $XXX $XXX as million to the to compared range is in U.S. revenue previous of

cash under investments we convertible well operations Note that XXXX million are guidance for of million R&D equivalents follows: We range million stock-based and noncash to of loan. million. $XX covenant term does estimated as to remaining as XXXX expense $XXX of our license expected expect into and and also our our our finally, other we million, planned is sales be cash, full net $XX as previous of the XXXX. revenues revenue includes new SG&A sufficient which paying product expense $XXX generate liquidity million to will QX not the the include and existing the from to our minimum And guidance fund compensation to compared $XXX to expect approximately as lowering year in expense be XPOVIO $XXX the up cash runway notes

our year be expenses We of to benefits cost-saving XXXX the recognize our ongoing initiatives. operating expect we lower full than XXXX as

our to be when I'll XX summary, flip are continuing the resources. we for and Slide to Richard? commercial our performance now diligent and thoughts. to over some while Richard trials of the Phase call focused In allocating driving turn III advancement on very final X

Richard Paulson

you, Mike. Thank

meaningful near provides us continued ahead Slide As you capital several focus cash have to milestones. we the our expense in believe see milestones on future. and of We on disciplined allocation can runway us XX, with achieve these management

for the myelofibrosis, about which substantial and III us our company. to optionality patients clinical enthusiastic are have progress transformative We growth with Phase bring potential cancer and trials benefits endometrial strategy, These multi in our and drive valuable myeloma. provides trials to our innovation

Operator? call SELINEXOR's a our company, a like manner in continue to Thank would we deliver portion disciplined today, phase we I again as and unlocking operator full will growth. us joining potential strive to to of As Q&A for ask on up to execute of open the the now next today's the and towards you call.

Operator

[Operator Thank session. now gentlemen, we Ladies question-and-answer One your please, question. moment, and first will the begin for you. Instructions]

Our first from Barclays. Lawson is question Peter from

Unknown Analyst

wondering on any if This being is And the wanted higher lines bit Peter. a endometrial sites, to screen the in for the beyond other trial you time trial change the rates? and on was Alex could expand is failure I implemented just for there driving changes -- what little in adding additional are I here?

Richard Paulson

I'll we some in highlighted kind and Yes. at what's it that to look addressing when it. Reshma detail the of to happening how level, high Thanks, she we're a I have into Alex. we the go but turn more and for really, learnings at and trial think endometrial

that So to I'll turn Reshma.

Reshma Rangwala

Thank Yes. you.

we So truly have the It Those defined highlighting patient their who data I benefit by of unprecedented. start population that endometrial long-term want the that back plenary in in was of This this to SELINEXOR one SELINEXOR this data important in And data gotten part first is status. pXX especially pXX We describe note, achieve the in the stronger. of underscores have the data really population to series. moderators it by unique presented XXXX. defined from was space, July ASCO only with the status. observed off can just

observed with now at inhibitors -- that population patients correct. patient PMMR fact, exceeds ASCO, wild-type you data In XX an in by PMMR their pXX XX-month PFS. median -- the survival months are unprecedented and both In the this defined That checkpoint show population those SELINEXOR overall actually are in status, who

seeing are enrollment. We our challenges in

a drivers, a in main very failure to recent unique increase trial. the and observation rate, of it's it's is screen One it's this driven biomarker and a

even myriad we reasons evaluated that ultimately biopsy And during status. fail those the that by that may wild-type, clinical of pXX pXX chemotherapy biopsy they Those we the are vendors, trial are Ultimately, in submitting biopsies can medical outside continue and physicians want relatively we everybody many is, That looking say on early of complete have if to physicians to of evaluated enrollment is said, on very to screen fail trial. patients partner that as the to initiatives, because can been this With that reasons, as may line I process. early during decide closely months we chemotherapy. need our is that are looking such, at higher patients they is that current and committed for lab increase affairs in pool initiatives whether rate. contribute for support a existing course, actively ENGOT. screen they reasons, it's top have time, surgeries, for multiple total of potentially reasons, seeing scan sites they And a additional to to that participate doubling need the going their with in are be updating that at down screen to XXXX. countries. new countries the at in completing and looking major GOG our that initiative we new activating of of we don't Other results

Operator

[indiscernible] Maurice Jefferies. from Raycroft The be from coming next question will

Maurice Raycroft

on the regions and about follow-up in? you saying to many just what opening those last Maybe plan you how one. anything a sites new you Are quick sites more opening anticipate

Reshma Rangwala

at current looking and some many been Maury. sites countries existing and Thanks like then potentially providing continuing said, not the additional in trial. I in Yes. No, primarily we're opening color new any that just up details to activated our countries sites already have for on our the support question, additional those

need first XXXX. enable top So think early screening I increased main focus pool results really we to in in line the achieve enable those those that will to -- that

Maurice Raycroft

is And And about could thinking the you population? biopsy do that of issue the way it. Or an the of help wild-type the pXX with on PMMR of help lead are mitigate I part anything outcome then that? to to there enrichment how guess, can this to front? Got any potentially Karyopharm process?

Reshma Rangwala

both process et are In classifications, is the MMR classification of cetera. say biopsy becoming smoothly. other very biomarker already evaluating molecular is will as as -- cancer, Poli, the the physicians pXX, care, I So going status. well standard really endometrial including because

So our driver trial the to chemotherapy a offset to just physicians they process still that They clinical again we main is really used unfortunately, results to the biopsy there's in Foundation is are interval -- to And matter biopsy months submitted turned to around very that Medicine. the They is do that the that of are of submit that nothing when between case biopsies trial. days. within it need quickly, nothing process. evaluating and our The specific complete. can of that, in

as In terms good are second well wild PMMR And of type your to question, I upon pXX patients we SMI. testing naturally, like one. think are tumors as see who it's a based to going local disproportionately submitting

rate think that we I time. rise over see So will

Operator

from Colleen Baird. Kusy coming will question be from Next

Colleen Hanley

PXX-wild-type has the how enrolled the tracking of well, given long data endometrial comment sort of the PFS those how just Can kind pushing some patients versus your of expectation? on enrolling metrics far so been? data strong and out any on another as that's question study. be CNO whether -- And PMMR might you Among how these

Reshma Rangwala

for Thanks Yes. the Colleen. question,

any in terms we insight no, results It's a not trial. do of So double-blinded the from have this trial.

also the these are of arms. much across either We one results very blinded to

So no insight there.

large And are of subgroup pXX just that strength of the just wild-type months, those wild-type to to unprecedented XX go PSS median subgroup, wild-type the PFS get SIENDO we we've into I'll pXX back reiterate right? In I'll continues XX.X be pXX an a that median achieved benefit truly incorporated data of seeing demonstrated that and assumptions. TMMR That a we've months. SELINEXOR in that really data on multiple had data with subgroup, think now those our report times. now data underscores to stronger, PFS in that the opportunity I can

a meaningful result very assume top of time the the incorporated projections XXXX that the readout. line been PFS we and top early inform benefit results So at that line has into already again,

Colleen Hanley

comment if you on is the That's the XX%? roughly screening still prevalent process? so thought helpful. in the as as screen can Got And was TPXX far it rate, it. wild-type biomarker Is then around it you failure roughly

Reshma Rangwala

of sitting it Yes, than is half in more It rate patients. of all is. that nicely assumed

Colleen Hanley

then one And Great. commercial I question, if can.

you low please? post X pre- can like help seeing the academic kind of treatment duration of the digits, in sense but therapies cell on give the Is a a just that, centers? you're month of range maybe or it us Sohanya, T just for get and a single us

Sohanya Cheng

Colleen. Thanks, Yes.

because takes that sources, for duration we don't months disclose time to So data we to mature. it of exact have triangulate multiple

impacted and terms trends However, dynamics the overall, a T align, duration, of take cell and at The this see but majority landscape, duration. post -- obviously, our remain a large increasing of of patients. helped to step trend obviously proportion obviously, in duration a bridging recent and really, of line patients the that competitive our look the launch and second, early is have therapies up. The smaller since propel the our back in drug third fourth in with we long-term

Operator

RBC. from is Next the Brian Abraham line coming from on

Brian Abrahams

benefits for where relatively Phase small number Maybe some shifting in of study robust patients. The Slide XXX to you rux, on on but on gears data SELINEXOR showed the of of you III myelofibrosis. based quite top XX, is presented a

pushed may So secondarily, maybe study was or trial or powering regulatory I was on -- in the looked if And drug based the from opportunities the study on to there. the of ongoing data bit just then as SELINEXOR the late-stage line there time a curious, is MF, it also the on out like monotherapy continuing, guess Pelabresib outcomes development. that's I'm any be adjust design

data us early the next? Just be wondering of -- the of the how or back of kind this year in we going should if is for the tell looking extent study end that now and could you at

Reshma Rangwala

Thanks for the question.

-- confident we So we're myelofibrosis. about remain really

demonstrated the I plus think unparalleled. the with mechanistic a we data yes, I rate XX% which the mentioned, monotherapy evaluated the in evaluated back population. builds data to and that data not preclinical if relapsed/refractory ruxolitinib. the ruxolitinib, you although as it strength have in really evaluating the a data JAK and as rate ruxolitinib, you we of inhibition the patients the SVRXX SELINEXOR only cohort totality but combined XX% SELINEXOR see activity. I the specifically SELINEXOR data combination, that Phase on a the clinical the is effects. is only reason not because, well say targeting in exposed trial that as This JAK really of have suggests the the week we are of -- JAK And you Layer synergistic can that that efficacy have goes And previously is that both data, upon smaller specifically data course, suggests SELINEXOR combination now, XPOX underscore of XX, in TSSXX now additive, SELINEXOR pathways have essential at I with that with with that non-JAK when

that data that is well really the and we're efficacy of strength and those At or add both cutoff, seeing the of an the time recent our SVRXX I of myelofibrosis. What the has extend patients TSSXX from physicians of potential to data evaluate patients in of rates. from very also beyond I as actually the TSSXX. those really most just none when So sets the know progressed looking either data, opportunity SELINEXOR all it's had the impressive durability. at standpoint as we inform also that SVRXX because

So well week well extend that what rates as as durability time XX TSSXX is the remarkable we and beyond corresponding seeing point. are that SVRXX

out of bit. Lastly, terms I'll mention Yes, in a we the XXX, lines time little push did

a 'XX. beginning of are population. 'XX, Now we patient looking of end smaller at It's

these So are JAK-naive still patients.

platelet to their needs within be to However, XXX. XX count that

smaller a in patient that to providing forward study data shortly. to as So look population enthusiasm, of Phase is III. and enrolling Still that it from the lots we population compared

Brian Abrahams

Phase helpful. down Phase thinking powering, lines I if opportunity there might guess really II, but time in the to size the effect was trial was I than even accelerate more III there? what an the in size you and be had cut a seen That's the maintain maybe robust if bit

Reshma Rangwala

Phase opportunity assessment, are that we the the mean that like Yes. that independent And exists if of do upon based to so the that's do. results. can It's question. have blinded DMC we'll an is all consider for their we results, trial. IIIs, certainly something not completely good I our evaluating we a But

Operator

on will [Operator line the from Partners. Instructions] Last be coming Leerink Chang from question Jonathan

Matthew Cowper

Jonathan. for on Matt is This Great.

we with are making the in some a there cetera, you And potential be programs top XXXX. other of to runway, get you the at of monetization And line the readout? cash cancer out-licensing if how the sufficient the cash such to as assets Just the thinking comment are as liquidity work? looking lastly, can line that similar about confident have from endometrial pipeline covenant, for relates such as way details of including KPT-XXXX et time the you to should updated it how

Richard Paulson

the Yes. first Thanks the question. third question. Mike second for jump then and I the and to talk let can I'll part, into

Michael Mason

Sure.

of the includes previous We've So our of runway previously. reminder, EM and guidance extending OpEx importance the yes, we comp, which million cash was operating XXXX. into costs. to trial our $XXX realized which of $XXX XXXX to down to XX $XX resizing $XXX that million just the was lowering expenses runway. $XXX be stock part is discipline million And our that plan of on from million, with continued cash tightened end a a million Because

We have pivotal readouts. X

First the first in one half is myeloma, XXXX. which is of

endometrial myelofibrosis second one third and the the in early Second of in half in XXXX XXXX. is

the those So that we our putting in excluding all early XXXX. due into XXXX, cash convert have gets October runway together, the us

Richard Paulson

a our Karyopharm dual of Yes. And by small of talking inhibitor novel early was molecule as first-in-class about programs. discovered I and stage KPT-XXXX, you we on, is and that oral think mentioned, MPG PAKX if it's part build

and rare recently, obviously, receive pediatric orphan as disease designation we designation. drug disease to able So we today, were both announced

where to make to or strong we're the patients. work So bring else of to it work asset to to I to help that we partner sure opportunity enable to really bring going that to be to full and a out-license or can recognize think value patients looking it someone

strong and sarcoma. Also, rhabdosarcoma talked So strong unmet have will sign Ewing obviously, which ELTANEXOR, some of that's which and potential in the asset second we given both us, our terms it, is high need given compound, to we we for in globe. the partnerships before, value across look that opportunity behind designations a those at novel with I think as

Asia currently Right in just Pac. partnered it's now,

always gives have assets we're best we then within to that assets. the at the look yes, optionality other those moving us opportunistic way And pipeline of from what's that So see to to a forward. couple recognize value

area we've FDA, looking some good been terms recognized I So areas of and by BD that KPT-XXXX adds recognize value the significant think think and the value. that optionality I and and with our to just the recognition obviously in

Operator

There I'd over are the turn no to Paulson Richard time. Mr. like further questions to at this back closing now call comments. final for

Richard Paulson

you, and on for operator, today's everyone, us you, thank joining call. Thank

of needs deliver day, are to on day to the momentum you and everyone. phase work to strive a as have again, each our value with people our look accelerating for joining as for on we thank generate patients We We focused continue we high patients and for growth, shareholders. next and unmet great

Operator

please Ladies concludes your lines. thank your disconnect for for We and and gentlemen, participating call you you today. this that ask conference

good a have one. all may You

Karyopharm Therapeutics (KPTI) 6 Aug 242024 Q2 Earnings call transcript