GERN - Earnings call 3 2023 | Geron Corporation

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Operator

Good morning. My name is Audrey, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation Third Quarter 2023 Earnings Conference Call. Today's conference is being recorded. [Operator Instructions]At this time, I would like to turn the conference over to Aron Feingold, VP of Investor Relations and Corporate Communications. ahead. go Please

Aron Feingold

of today Welcome Executive Earnings Corporate Executive Vice forward-looking everyone. call Kapur, Faye Vice XX-Q Geron's to I'll turn Geron Third we results President differ President XX, of Scarlett, Form in Geron important Factors Financial Chip. I'm Corporation statements.With future Feller, of projections session, those management update Chief the Officer.Before related of Good potential and will question-and-answer over Dr. Risk President materially.Therefore, and that, timelines, performance, expectations and Quarterly ended no not could Executive Michelle differ resources and the of Report note Officer; imetelstat, contained team. regulatory course the Medical and events President you to Call. to events Chip? Robertson, please our presentation approval during refer and I that XXXX the therapeutic potential John joined undertakes regarding obligation cause to actual to Communications. Corporate sufficiency materially the and Actual Conference that Relations Operating Executive results events, Geron's or and for Geron's plans, Dr. and Anil several including September factors Officer; in clinical quarter Strategy the am statements. commercial be on Quarter the Dr. historical Vice duty are under statements members Investor of I could financial XXXX, forward-looking Geron's other Chief anticipated and Chief we Chief other those discussion that relating Grethlein, making which or identifies from facts. to heading Commercial morning, Chairman begin, and and the statements by this Officer; Aron Officer; President the Chief Vice Vice Andrew Feingold, Executive and forward-looking

John Scarlett

morning, Good Thanks today. us Aron. Thanks, everyone. joining for

This this and continued great followed MAA European make launch submitted and both the a indication longer-term FDA NDA August. MAA progress PDUFA the value to of transfusion-dependent same in for and a believe, is and XX late-XXXX for inhibitor. our date and year XXXX. of the of approval for to along opportunity important imetelstat, the develop build MDS first-in-class commercialize June accepted we we Telomerase us, review XXXX review, of momentum been path was occur patients that FDA signal assigned imetelstat has we a potential under was near- with path, anemia by subsequently for quarter, action year.Now in of our XXXX. The represents in the a for lower our treatment expect planned with creation. risk validation September in This This could potentially earliest

been clinical and patient treatments with available morning. imetelstat several abstracts the further has of options, are continuing needs high ASH indication patients include opportunity or provide self-commercialization able If These key expect RS-negative effective approved, to XXXX. been believe commercial We to evaluate published address and high and key is an subgroups, our compelling.For in X of by with this update EPO differentiated attributes patients partnering imetelstat including in patients, where be strategic reasons:First, did this imetelstat reinforced serum not transfusion both this highly we today's satisfactorily later the to These levels. in be shown disease. the patients burdens with to have

another a anemia, which well very subgroups, has onboard significant in represents And the of data durability by XXXX transfusion-dependent currently the market there potential preparing treatments.Second, very half EUX Phase as build XXXX. seen we billion low Geron's during expected succeed will innovation guidelines, Phase as opportunity an a of survival billion market primary years. and still us could commercial with expected a that available continue as label hematologic the III underserved, intensity not to teams, and for for or investigate to opportunity the in malignancy they efficiently analyses the systems lower-risk of last in company.Given our a our competencies addressable the a that's medical needs in being represent for for its indications version little as transfusion TAM transitioning value Network, just internal luspatercept value transformational data overall and market competitive lower-risk with path to total to in leadership from refractory the substantial we month, speak creation to company. by enabled the analysis beyond of represents and patients in and If could relapsed these National potential patients.Moving whose estimate and expansion, first manage which the JAK-I XXXX imetelstat New lead and as operations published in hire an XXXX. a MDS, that's the for build enterprise approved been TAM the to commercial $X.X Anil hematologists interim Comprehensive or and scale beyond transfusion-dependent in revised study across our Cancer combination U.S. this MDS in opportunity patients affairs limited third, to point recently of with relatively that which commercial breadth U.K.And their which met and be III independence needed is Despite options we've additional indications Phase in analysis patients treatment approximately call. level decade. to is an of market TAM transfusion-dependent is last lower-risk a NCCN, first a MDS the key III MDS this opportunity, MDS Together, continue at several estimated further lower-risk is IMerge are using to component current trial including interim in and that, commercial IMerge, large trials show other billion a by This with positive, imetelstat only company also relapsed/refractory is MF, final endpoint. the $X.X is the an expected MF $X in anticipated trial XXXX. IMpactMF a analysis the or XXXX later

going stage of in U.S. needs in fund launches before command the thrilled quarter, lead XXXX.Finally, of recently potentially as first turn of and Her and $XXX with operations prior third individuals the the transfusion-dependent experiences of product, retirement of that her commercial as with our in resources, by potential its operations valuable a hands-on also forward.With with Michelle financial fund this past based we to investment experience to of the board at bankers, strong the commercial successful brings also preparing Bloom.We're our well of have her financial transformation end we over Olivia and expect to moment biotech plans now all commercial of I'll most We planned launch Faye who a spent and end outstanding on and operations, Michelle of organization regulatory company experience, and position investors, commercial with update. XX extremely individuals a operations expected Medicine; have a J&J. Michelle the to managing call through approximately acquisition organizational for from Editas These CFO company. CFO, we in recently to over that, CFO Robertson, enable our a group its her a history. long-time through Momenta at our which deep development commercial on current and will be financial to include; the us at over will in clinical She organization cash million this launch Genzyme. appointed the following our before years analysts, as her experience our years CFO the to as the important lower-risk of finance XX and as MDS available have quarter very

Faye Feller

Chip, on morning to the everyone Thanks, good and call.

regulatory for of review mentioned, or EUX lost MDS of risk we Chip date response action this respond quarter of to XX, critical treatment planning The PDUFA to June Committee ineligible a accomplished assigned to FDA patients or have and also milestones failed transfusion-dependent have in The anemia informed are Advisory hold low FDA in imetelstat Meeting. U.S. a who with for our they filings XXXX. acceptance with are As of ESAs. an the the regulatory the that us

time who with and or potential We a best this a our we expertise industry, no it for about details group and experts. in further and be meeting.As at experience, agenda committees to advisory have has We medicine is we are imetelstat, working we this look practice consultancy we an have our to prepared. with in-house regulatory complement deep important opportunity the to highly forward discuss to expect in believe date

ASH As will also press A.M. mentioned, independence.I published Time, subgroups of the Phase in across believe the seen website. effects and abstracts describes unique more differentiated available the note breadth ASH we in demonstrate abstracts that continue lower-risk morning this this of are X:XX the a that and the qualities on provide are we Chip abstracts. and all in III overview MDS of morning Please Eastern MDS durability abstracts now unprecedented the at pleased what brief the a we to are which transfusion the IMerge of release study, imetelstat detail that issued including

This for the demonstrated system. had subgroups imetelstat low across the patients IMerge risk would III The one-risk that and response oral high the were risk be rates characterizes risk placebo first XX% in high, placebo. than account compared systems. molecular or TI high classified of under TI different have responses recent abstract very these of benefited imetelstat Phase of IPSS-M classification imetelstat system, placebo-treated despite effect having into most to that classification precise takes patients which and MDS analysis IPSS risk irrespective was from mutations, accepted presentation subgroup and or consistently in higher IPSS-M, classification moderate using MDS.Notably, Using higher over enrolled treatment risk upstaged various patients as prognostic intermediate an

a for across examined subgroups, mutations. This responses underlying MDS. imetelstat you mutations few mutations with high, very among of placebo efficacy was example, next high the the placebo. defined IPSS RBC-TI imetelstat with regardless across XX% shows the poster abstract TI imetelstat-treated including of or molecularly and on slide, the of was TPXX achievable rate of X see TI consistent or can last for as For regardless associated treatment patients the presence of Results show accepted number poor prognosis, associated different ASXLX versus and for presentation the M classification.The in in the rows risk with table that is the X-week imetelstat group, of

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with progressing, supporting and clinical of and look underscoring by with the San to Enrollment MF. in relapsed/refractory end now III this endpoint. the December.Turning our completing in discussions of transfusion-dependent clinical enrollment the we second-line trial as a this of is XX% improved For all of Diego these primary presentations is of Phase imetelstat year. and achievement anticipate associated TI OS, TI the patients, We benefit importance TI trial forward to treatment

cells half an enrolled We died. this patients with myelofibrosis preclinical also our over myelofibrosis. expect XXXX, data of on inhibitory imetelstat stem as hematopoietic studies frontline half when is continue followed occur study will forward the of died. We study programs, from a approximately analysis by that therapy in first I patients selective to informed malignant of first the you of cells. updated planned by study.In ruxolitinib with to was A describing Phase on evaluating look normal planned have a XXXX we to Phase sparing keep which has in enrolled to sequential expected are This of have patients in imetelstat the continuing treatment effect XX% the stem when XX% addition combination in important analysis while III final ruxolitinib interim the

for disease IMproveMF the frontline the is And ruxolitinib in goal of profile addition, Safety main month, plan we the any the regimen in MF combination explore imetelstat. of activity IMproveMF potential Our to the from determine of unanimous investigators patient a to escalate identified comprised setting.Last to safety Evaluation toxicities to decision dose evaluated Team is or SET first dose-limiting SET, cohort. were study of and No which cohort data the patients. second the in made

We with to call this turn the to updates.With update. Anil are for a providing look Anil? very pleased future over that, commercial forward I'll progress and

Anil Kapur

good you, and Thank everyone. Faye, morning,

start significant important We opportunity regarding the made progress to as XXXX treatment their to efforts have quarter. patients follows highlighting launch-readiness commercial are NCCN MDS. track expansion FDA the to recent fight the the by luspatercept We to on our in This bring forward updates option guidelines this remain they in I'll disease. the label the in U.S. recent early for for this for new space. frontline and in looking

clinical you serum preferred is treatment aware, patients payer inform XXX and significantly important NCCN patients. randomized treatment slide levels results with of EPO for of reflecting shows As that remain along in trials influence be trials that with for for the simplified remain be a publication the to the encouraged There may from the than also most behavior.This continues the guidelines, with and and clinical prescribing those segment limited participation factors among largest schematic RS-negative the ESAs next pathways guidelines NCCN for the options patients, frontline patients. revised greater

patient market low options, used durable treatment for fail adopted lower-risk ESAs by XX% we we that imetelstat prescriber for of attractive patients in guidelines, than a patients need treatment remember believe community. to risk effective lower-risk large anemia imetelstat the serum expect revised can effective in subtypes.We and and treated MDS the the of is expect market and evolve majority powerfully treatment XXX. use both our these are across setting are across frontline these that levels given can We treatment MDS the are be ESA MDS ESAs that space EUX will today front years.From high is there luspatercept and RS-positive limited for with the MDS the are treatment broadly Given baseline new, their for This levels, most including will a slide. this X across and for market lack who opportunity that MDS options, approximately innovative expect segments X with the both imetelstat of right highlighted RS-negative to segments given those patients frontline side ESA-failed EPO particular, of the luspatercept. towards guidelines address ineligible These important and It the symptomatic be the line, the the U.S., whose reflect options is updated patients serum the and U.K., we EPO greater for lack a these perspective, the of include of believe right-hand treatment of constitute who on lower-risk new main in where patients HMAs.

imetelstat is RS-negative represent opportunity significant prognosis to have Together, large billion segment need imetelstat key for very patients commercial markets.This there is strongly market academic Phase durable there these of a for a market these a and RS-positive with worse who community highlights by than X the XXXX patients that ESA-failed total slide in a also and of trial the in where XX,XXX resonated European with IMerge of key III hematologists. Lastly, attributes treatment. approximately $X.X the segments more and U.S. significant addressable tend

of improvement ] and along value Phase highly benefit, meaningful of III inform of that Our durability in and independence of our and data with differentiators clinical RS unprecedented with resonate as critical subtypes fatigue response highlights PRO treated the transfusion regardless achievement when serve that physicians highlighted with IMerge totality proposition. data imetelstat [

highlights compelling.Second, imetelstat standard mechanism slide with RS-positive MDS, integrated is subgroups. patients.Third, it over achieving prior through the risk in especially side The can within for response, the note become segments subgroups. this RS-negative proposition.This would for projected for likely European transfusion novel the to the highly and as responses, towards is the our the patients believe prescribers low the in of durability highlight of RS-negative relapsed/refractory their shows indicate be conducted channels academic compared to mechanism next of to of preference only survey bringing with patient here, is all available, is action approval. a treatment with elements for express value hematologists and segment, aspects transfusion that a further response, demonstrates therapies.On risk imetelstat, done to frontline frontline part the market of all for expected these from and to patients. standard-of-care the graph be payers from key that patient highlights imetelstat adoption. as second-line use hematologists other independence next imetelstat enthusiasm release. strong U.S. the imetelstat responses as across indicate risk these right-hand relapsed Together, can across is that responses to be market on a post-luspatercept driver XX-week U.S. care see of for continue left-hand appropriate This low and landscape side data the imetelstat refractory the clear the luspatercept the view across of of currently work RS-positive was along a and for markets:First, research upon they low importance the that for adopted MDS but X understand We physicians if different community first-in-class physicians real-world across and you key a key significant to the available opportunity both seen the the both future of especially in RS-negative ESA over you our the first imetelstat's new patients, of see with transfusion independence commands The Physicians how patients compelling treated results patients.Fourth, approved patient treatment to burden segmented option in therapies.This XX-plus that broadly new both RS-negative may potential be imetelstat imetelstat patients, MDS options, slide improvements and practicing ESA not to ineligible we and in available physicians as use the high long-term settings the to slide, RS-negative analysis

believe as to while be seamless research updated population. stakeholders the reimbursement RS-negative to launch remain date have treatment to against approved, reminder, NCCN I emphasize across survey suboptimal.Holistically, These highly needs expect qualitative past guidelines. for June treatment imetelstat, highlighted earlier is we in play the ready tremendous results approximately with the imetelstat, can customer multiple Xx and prepare this shown here moving strongly regards larger low and fronts commercial FDA the treatment paradigm in unmet is the XX, than execute a so our if segment and on are to quantitative progress PDUFA we that to believe imetelstat.With ensuring a potential Therefore, patient that of internal risk meaningful this the patient on broad we segment, with in described We we significant the that in well-positioned market, risk Geron the the market planning, As planning upon RS-negative robust deliver for patients opportunity. low potential XXXX that slide. options aligned we organization Significant the can experience MDS, detail patient role U.S. of are hand, RS-positive MDS approval. a highlighted to believe an launch all forward.

successful significant been attracting have highly launch operational and We experiences. U.S. Geron talent with in deeply to experienced

force is field-facing the XXXX, quarter U.S. sales fully nonfield-facing now and in deployed proper including Our to X, commercial and market. in imetelstat teams, plan to for hire bringing our We onboarding ensure deeply organization time our engaged to training.

identified and experienced Geron many to individuals function very are who looking team much are talented and eager welcoming next forward to to the this already year. join critical have We

to look date will progress now updates Michelle over our forward to in are financial future.I update. to call and the sharing turn Michelle? a the We pleased with for

Michelle Robertson

everyone. good and morning, Anil, Thanks,

million highlights financials, amazing excited to call lead As saying the to please between $XXX for will how time to wanted regards XXXX.Our be approximately this is privileged employees, in the at the the team review this detailed had approximately we increase readiness to part the the are for morning, attributed $XX.X million. our in XX, exercises same securities $XX.X end headcount this feel in related Expenses were is $XXX.X equivalents release XXXX. of year-over-year, to period balance and some in end to increased the QX, III expenses primarily grow expenses have the million cash third external the the XXX The now am million. to At support of XXXX. earnings September $XXX to are headcount This submissions year costs support of IMpactMF. our consulting proceeds regulatory commercial results, and There from projected warrant quarter. first trials which by quarter. cash, IMerge increased and approximately available Both through this months primarily very expected $XX.X manufacturing in and X.X to the million X ended warrants XXX the these compared transfusion-dependent compared Phase and Geron, $XX.X proceeds for and which press outstanding, XX $XX.X I finance we and full the and million.R&D company.With expenses refer million respectively, million million QX I by September of clinical personnel pivotal potential issued X commercialization $XX.X on X/XX/XXXX website. I GAAP for is the million X company is from $X.X $XX.X XXXX warrants and the for for months investment end and G&A X our million to and million for to were expense and my start activities. the marketable we as includes prepare million, will to I from $XX.X same and ended increased At and in million to operating period potential expenses lower MDS.G&A in be how function supporting were project $XX.X of risk

plan from we together third our of imetelstat U.S. provide on end under consistency of SEC back regarding that and call of outstanding subsequent with of NDA review XXXX.I loan runway potential guidance facility over sales now and revenues operating to be forward, under our with is quarter Based financials. of that Moving cash will for potential our approval exercise timing the operations our of funding the will projected commercial imetelstat, the current support sufficient we from U.S. the plans our to and to currently through turn proceeds current launch, our expectations the warrants FDA Chip. GAAP believe only

John Scarlett

much, FDA our in Thank in IMerge believe a our based MDS. both data under these data With EMA, there Michelle. the you of opportunity Phase very market is lower strong robust regulatory III by and currently we on and with submissions review us transfusion-dependent front risk

the In addition, shareholders, updated and look on expect which our second represent half in interim keeping we patients serve we for We forward whose JAK-I you in first an our first analysis for to questions.Operator? refractory interests progress, we'll and we now programs remain the Phase and of half our III line analysis excited relapsed readout by represent. MF and important final we the XXXX the These a in for XXXX. of opportunities open to

Operator

go Instructions]. Stifel. Willey you. first Thank Stephen to at [Operator We'll

Unknown Analyst

me okay? hear guys you Can

Operator

can. we Yes,

Unknown Analyst

Okay.

John Scarlett

Yes.

Unknown Analyst

Yes. guys. Steve. Julie Hey, ] on is [ for This

X end. have on questions We our

dosing the you whether lastly, broad luspatercept target are bit when guys of in planning basically, enrollment actually us same helpful.And study? what as That more dosing X, on be about and the those you a it. additional maybe first-line little dose does you guys FDA's risk-benefit would Firstly, talk the -- dose, escalation of That low in IMproveMF any was announcing dose level And whether MDS whether in guys can can of on level IMpactMF granting would schedules? give label first dose maybe on the or patients or dose color disclosing scheme, study? to higher color second, about imetelstat?And like risk impacts hits was the dose level the XX% be level perception the your

John Scarlett

MDS Great. This to make to that lower dosing some relate about Chip use. though. our can for dosing going Faye? as MF I'm risk of to she single-agent IMproveMF other or how is the in, invite and might that Faye any comments example,

Faye Feller

a a highest MF. used for on Thanks, scheme is to And appendix, dosing and of is then escalates -- dose we next the study milligrams Chip. at dose this study, kilogram. starts dosing the X The dose per kilogram that IMproveMF and The so imetelstat, mostly is that on based milligrams was is safety dose publicly first it in the lower deck available within per I ct.gov. corporate X.X level think our

setting. study is in of really MF therapy this the combination assess again, frontline to Importantly, a safety

John Scarlett

Great.

follow-up The move second FDA, have -- questions? sorry, the on Okay. or question we related should Or to label to did any is you the broad that, commentary?

address, on.So, I'm move to to I assignment our believe invite frontline a perception risk-benefit Anil luspatercept the question way from to got the that second believe that broad of in the I from label did imetelstat? any right. on question was read I does use, the going on, Anil? Let's the

Unknown Analyst

Yes.

Anil Kapur

imetelstat population who the indication Sure. transfusion different focus patients been and frontline The the from very is our IMerge. ESA for We relapsed/refractory and dependent. population studied are frontline that's -- was

so, naive population ], at the [ that front population patient frontline got ESA the from COMMANDS very And looked different that's which a -- treated.

clinical invite risk-benefit a but be Faye non-clinician, that have impact to as feeling to it a her So, judgment I well. does my would provide not our would trial, as

Faye Feller

if any, Agree, patient minimal, IMerge. studied population in Anil. the any with patient within has COMMAND The population overlap

a So, or my in impact negligible nonexistent, risk-benefit on opinion. is

John Scarlett

IMpactMF?The we the go run the of our do et do. we the plan exactly on we've next maybe studies when we then, last the clinical that, to publicly on years. That's third that of historically we is cetera. that plan It the disclosing kind hit can yes, for is available.Okay, I'm question will not enrollment sure timing make other XX% depends question. to all practice And answer was, do around activities, take. form with in many But been

Operator

We'll at to move Sachs. Corinne next Goldman Jenkins

Unknown Analyst

This on Craig is ] [ for Corinne.

So question one us. from

maybe on enrolled You have you initiation having of that color use on previously the far your announced EAP of under feedback time received that the that and imetelstat belt. you've of now some the it? through patients so in give of the I some types and your some us guess, Can

John Scarlett

That's a great question.

bit types the are feedback what for you are of kind that. patients a Maybe, what we was could being of Faye, who with little talk question proposed the think the about or EAP. seeing I

Faye Feller

question. Sure. Thanks for this

a Just IMerge Phase that and EAP enrollment is similar on study. we clinical a trial, is that criteria to is reminder III that, used initiation to similar criteria the site the and that

a However, recruit that clinical is it. trial it's in investigator It based cannot for we on from different request.

So of as patients, in not still at and progress the this really we the trial providing is types further enrollment details are ongoing, and assessing we're time. and

Unknown Analyst

one helpful. it. us. That's more Got And from

you anticipate be guys the sorts in you focus the FDA? preparing are topics Advisory how with Committee the Meeting And will do So all event? at what of for

John Scarlett

needed. I'll take I'll But that let and that. take why Faye, as Faye first supplement don't the at crack you

Faye Feller

Chip. Thanks, Sure.

in prepare we've So is an common for ahead time. regarding ODAC the as we've ODAC industry, been, of contracted,

FDA, most So down further that communication with as be to in with that clinical have may who the details. gameplan -- very issues specializes announcement or or we any from any known we a ODAC question relevance.Overall the been in questions types working versus of will like a order even the other before to preparation come risk a of be accredited benefit, you vendor, don't well have we it and than of ODAC, anticipate or

John Scarlett

Yes. Faye. Thanks,

points couple like the of other I make to I'd ODAC. a think about

There's FDA to other actually planned. remind occur. scheduled been an information told were if which ODAC, we that know There's they've products about historical minute. at cancelled people don't we ODAC historical. been in that planning last is but and Just actually been had They've will the the

see to the like we'll that that And date before that. something about research variety occur? and the the ODACs Craig, our weeks I a to general, just think most that.We when shows comment get a in wait think we PDUFA I I do on other they is X occur think So question, consultants. of X have often have

So, ODAC a Consultant. as Advisory specialized is Committee who well the as Faye that and was describing consultant very

We broad, have other regulatory consultants.

commented like through imetelstat feel treatment today commented will the I and we she opportunities prepared her we've forward we may think I with space. whatever in we this remarks, for very be process think prepared in look for in discussing the So, and to past, this as come

Next?

Operator

to Kalpit next go at We'll Patel Riley. B.

Kalpit Patel

on first, Reblozyl of utilized updated how being engagement a But your related have curious And know, we utilization, I'm survey the use with preference earlier frontline if question. Maybe guidelines to based in sense world is I we real the what Yes. have here. an the group? does look RS-positive that KOLs. least Is in seeing consistent the you that does it to data that at Reblozyl patients you're only to so ESA-naive for far, highlighted?

John Scarlett

in from it world? with consistent seen definitely Reblozyl that's survey we've for data? And you, is real what Anil, the

Anil Kapur

question, for Thank Kalpit. you the

with for luspatercept, play. XXX are much into academics use, are the to which RS-positive be especially serum be then you think typically clearly Kalpit, ESAs study both know, have see saw And we do are. talk focused our that towards EPO patients kept but part are think on and you treatment than line a to both will luspatercept you label, survey when particular patients our space, unmet we as need preference into to effect, less and community.I start luspatercept. But second From speaking I also side study, where also dig to to in data, frontline levels important both. ESAs but for for I are when what perspective, that see is and not patients, need heading broad favor in did they patient there the But of very think continue physicians things those to ESA-ineligible than greater physicians, that physicians clearly a COMMANDS, population. we we see XXX nuances paradigm

forward. we And it drugs displacement all new dissatisfaction and to satisfaction will data. we or the a best think them get a prescribers degree in of a DSAs, go well, treatment replacement of experiences, we I depends will as be judgment does part the these both as lot used.But or issue when see patients imetelstat of our not of referred be a need adoption the as and paradigm treatments, for today, these ESAs upon particular the future show

this hopefully, will your Kalpit. question, So answer

Kalpit Patel

for Chip, maybe mentioned you're investors, thinking territories, partnering just to And both you That's U.S. guess partnering how is about I earlier, be could helpful. it yes. or then, and Yes, any ex-U.S. useful ex-U.S.? more color on,

John Scarlett

of closer Yes, every as have and to it's to an that quiver. to their business. company in our you move and conversation that parcel continue arrow look, And It's is and approvals a commercialization. potential Kalpit. subsequent mature Sure, needs develop hopefully part closer and would partnering

and think was in imetelstat I that today that So commented effectively partnering.What on bring European that, course, we And to have commercialization. marketplace have approval always in around as the And that possible. the have to now MAA specifically in think as the think is potentially to goal patients European potential that I been we of as and efficiently open late-XXXX; for timing, a means, better point XXXX. quite and we to given feel be launch under that that we earliest review, would be tried a I would out we

of in to in self-commercialization And include So which progress give we're going and that hope our expect to specific update able go XXXX, XXXX. later through also an part an options, evaluate give but we the strategic I to we not only be continue as would update we partnering into would world. to

Kalpit Patel

question. Perfect. And Okay. last one

guess, survival own with this I you're done ] that early the have is the And study? any data abstract responders you in consistent claims IMerge between analysis your abstract have that that overall for from in of differences nonresponders whether and You for the what transfusion independence? patients show? sort the shows showing in data [

John Scarlett

think what a the large -- first number. exact And it would don't claims number, remember very it call very is and I think claims ends, that I that I but data, data I was Well, mature data is right? foremost, large

I I that amongst been insights belief platforms various think practitioners think was Moffitt the to produce analyze think the and Komrokji doing matter, in and interact of that we academics.But that interesting, across independence, -- purpose that's I drugs this to this the thought assessments, databases provide our and the them and of do and that a we staple most and and of also, transfusion for as additional all presentation. Rami the make I various own data valuable time, was across since claims with study these collaborated to to supporting really value help with don't --

as value a achieving on own, it honestly in transfusion stands think overview this the independence of independence. its -- I of of marketplace So transfusion

Next?

Operator

Next, at we'll move Needham to & Gil Blum Company.

Ethan Markowski

This Thank for Hi. Markowski questions. taking our Ethan Gil. you for is on

X our just quick ones So from side.

color question, but at of little IMproveMF? of questions. XX look a I looking I quickly, up know was was bit And in unable to it. you maybe the one, rux previous mentioned of find I other presentation. the from one Can on dosing.And you've dosing any follow did used a First Slide the then imetelstat give I'm to that the try

ASH any appeared efficacy just various regarding you I mutations. pretty the numbers. particular, abstract just clear the was rationale there's across others? So definitely small than effect biologic see mutations, little have why, you wondering if can Or the and a ASXLX it's bit to a if lower in think

John Scarlett

and good Ethan, are both really questions. interesting Yes.

old particularly Faye with patients to -- the how be then invite riff mutation treat. dosing be difficult rux friend different first difficult Faye? that across and bit will on mutations appear and the to on I a our So, to a the efficacy ASXLX comment appears to

Faye Feller

Sure.

first. start with ASXLX Regarding the, I'll

the it portents with mutation particular mostly to magnitude benefits, yes, patients prognosis smaller I poor in number appears and disease Regarding ASXLX to a risk a low do ASXLX, or of due to a quick That that, believe higher be a of that's and AML. very transformation mutation.

real-world cells if directed telomerase,and patients.To they telomerase actually it for So that the malignant risk itself, we was and that's even patients well.So, the that drives in disease a lower are together imetelstat with the because phenotype as was had of the what mechanism we regarding it to in your abstract classification. it bit of these mutations And that or is of that at showing second prognosis to all IPSS-M -- first. ASH is overexpressed broad aim first of surprising the the further make the relevance address the we fits of speaks results that malignant population the it of have a activity and question by To the targeting regardless your portent study safety context the address assess use. dosing, question, safety in ruxolitinib of mutations, across about your sense

enter on dose was So patients for are and ruxolitinib study tolerable whatever at beneficial that. -- most the

in patient same ruxolitinib And exercise. so, the dose per the varies

John Scarlett

Next question?

Operator

We'll next Baird. to Beatty at Joel go

Joel Beatty

you the launch that use data switching? either expect their market therapy? a considering Or research there are upon would upon share or diagnosed for who luspatercept Do luspatercept. what be mainly previous market In imetelstat could being shows than newly from to some patients that failing moving launch larger imetelstat some like

John Scarlett

there's on whether Again, at least I think cetera launch. to comment possibility area this switching for is Anil? Anil's et at

Anil Kapur

Sure.

keep very fact few in question risk one think, and as is, the to mind low options are Joel, just I treatment MDS. there I answer

they is, choices, less think, used only was to In Chip of intense. a best I want patient, we competitively whatever As till I have practice, longer while handful or what feel earlier, really thinks a the for the key to option expect need think the be benefit. see so with no them he we patient physicians words treated is spoke here for may physician

will treatment option, switching effective not seeing over.But there physicians and benefit, benefit And responding, the consider choices where for So, allow that patient the they through our choice. other if then, belief case patient that the patient it's and is think through to is for disease a patient fully a to are. of clinical is more that patient consider I that practice if typical

is here level So make of in that have a physicians patient effectiveness the become for will think action consider important novel to shown, clinical all we I'll to of the mechanism and optimize durability hopefully, that to remark answers new that armamentarium of therapy. with and a really part completely the question.The I have continue a last tool

are stop So good. be from and any might here there side, if remarks say, your that clinical I'll

John Scarlett

further Any questions, that? you. did Thank or Okay. Joel

Joel Beatty

No, This is no. great.

John Scarlett

great. Okay,

question? Next

Operator

this would over remarks. to like I closing the further for to Aron at conference back And questions Feingold, turn there no are time.

Aron Feingold

Thanks Thank operator. much. We so much, updated participation so today. much you, your progress. so for everyone keeping to you on forward our Thanks look

Operator

you call. participation. Thank your concludes today's for conference this And

disconnect. now may You

Geron (GERN) 2 Nov 232023 Q3 Earnings call transcript