Earnings call transcript Q1 2023

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

Operator

Good morning. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Corporation’s First Quarter 2023 Earnings Conference Call. [Operator Instructions] Thank you.

Aron Feingold, Vice President, Investor Relations and Corporate Communications, you may begin your conference.

Aron Feingold

everyone. morning, Good Geron the Quarter Earnings XXXX Welcome Corporation Call. Conference to First President Feingold, Relations Aaron am of Geron's I Vice Investor Communications. and Corporate

I'm Commercial Vice and Executive Corporate Executive President Vice members Anil following Chief Financial John Kapur, Chief by and Officer. Faye management and and Officer; Strategy today Feller, Dr. Executive Executive Dr. and Scarlett, of Chief of Bloom, Vice Olivia President President Officer; team: Chief Chairman joined Geron's the Medical Officer;

or that of potential during question-and-answer under for that commercial you note ended materially. results Form and other XX-Q XX, forward-looking Therefore, course important other the Actual Risk to of be Geron's Before anticipated no and forward-looking and please differ the therapeutic historical approval regulatory we statements clinical quarterly that those or which the on future undertakes differ refer Geron's and the update are XXXX, heading in statements. factors those events contained of this identifies presentation plans, actual session, time making in relating begin, and the projections including related expectations not will we March imetelstat, sufficiency events, financial cause to materially I statements could and report forward-looking to regarding facts. obligation resources potential the duty statements. events Geron discussion quarter the to could our from Factors lines, results performance,

quarter www.geron.com/investors and Media first XXXX of well under in & Events the our section results highlights. Please call business as release at the website press slide deck financial refer today's for as to our Investors for

remarks; will and including before concluding our will give will the follows: and Chip perception; highlight Faye regulatory physician capital launch ASCO provide and discuss at Q&A risk medical accepted for provide XXXX the financial progress results opportunity, conference and be today's update, to commercial Anil EHA and current of call MDS Olivia update; insights remarks will provide review for data agenda key planning will and a going first affairs The provide presentation a and as resources; lower will session. an quarter Chip overview introductory

Chip. the I that, will over turn to call Chip? With

Dr. John Scarlett

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

the Geron, aim will commercial in in malignancies, lower of and a heme we At first-in-class proposition. relapsed/refractory to telomerase myelofibrosis. provide of transform standard we to highly inhibitor treatment poised Imetelstat, significant MDS believe is which our value compelling differentiated a become risk care

can in noteworthy patients this which data, XX% durability know represents and match there lower risk RS+ lower that agent No in no IMerge of this particularly patient unprecedented In MDS, subtypes, population. MDS specifically which well other drug approved the today opportunity this today patients. as is level is RS- X is across transfusion durability about on of based independence of RS- TI both, risk Imetelstat's activity showed an in this as of including patient MDS. for of because Phase our major benefit patient we population, breadth the

harder options. and to a as of RS+ these clinical therefore, for new molecular inhibitor are in accepted abstracts featured further evidence some in for current as that require treat discuss cytopenias disease of patients will critically Unlike modification confers telomerase patients presentation data, at patients seen fact, In strong consequences. safety on-target that treatment are mechanism Faye action compared as imetelstat generally which options, these a RS- novel a limited treatment clinical to has the EHA. well-defined well profile oral have and two

improvements from in abstract were on IMerge imetelstat-treated compared more Faye to improvement more experience sustained patient-reported Phase X. quickly. outcome another EHA This will patients have that likely such to abstract meaningful based highlight accepted that also illustrates data is fatigue placebo, and

for these Based FDA will on next compelling a we're Phase The month. to request application new review. submission X include the to submit our on priority track drug data,

commercial is for planning and customer for ensure Anil's goal U.S. Under and approach We're stakeholders. organization elaborate to broad to in Our be call. ready leadership, seamless taking launch imetelstat a a which all early commercialization, and deliver for in we're a product, our integrated on launch the reimbursement later deeply experience the the for commercial to prepare to will market cross-functional our XXXX. Anil

We MF of follow-on or indication treatment X TAM risk XXXX. options. can risk total half address a the billion today who or overall is these MF risk Phase lower lower that's of and imetelstat has imetelstat patients, After of out a standard a unmet significant than the primary to study needs Geron attributable that that positively, If About TAM believe relapsed/refractory in in MF EU $X also relapsed/refractory approximately of endpoint leading expect limited addressable survival. patients billion by indication. care we reads greater anchored that in MDS, the and opportunity significant in become only transformational have patients MDS for very potential study a JAKi first $X.X lower market has to U.S. for MDS to

the quarter through over first financial third which operate of close, to the us XXXX. wherewithal million the of company end as the the a From we on perspective, the quarter balance financial have $XXX sheet gives of

launch we such, expected malignant while study the overall in Phase our our we're program, survival hematology of risk X uncompromised restraints MDS, financial positioned to believe the of MF. readout supporting including imetelstat in relapsed/refractory As rest lower also by

for action pathway, our imetelstat to and a a financial clear differentiated resources unprecedented combination winning I bring regulatory to as of treatment for market potentially and driven highly represent with a a believe experienced team our clinical solid date data together to patients. the transformational potential disease modification, by mechanism

our me call let Officer. the Medical With to over Feller, hand Faye? that, Faye Chief

Dr. Faye Feller

to Chip, you, morning call. everyone on Thank good and the

tremendous the preclinical, regulatory, FDA First, next month. teamwork to submit the MDS expect application CMC to as teams and Chip by the mentioned, and impressed NDA. the risk new in I'm of drug we to clinical prepare deeply appreciative of the lower

meeting. the ASCO been results ASCO and at presentation are oral upcoming accepted of EHA The abstract patients EHA for online June our very on remarks. EHA May MDS on further of transfusion for be their are was described we independence, this IMerge for potential in line website and covering durability evidence at modification imetelstat-treated morning ASCO Phase my be contents outcomes abstracts Next, longer will on Phase in patient follow-up on posted I website, available that The Xnd, disease data annual The reported low-risk the top pleased of IMerge and will on X. submitted abstract X all and accepted have the abstracts and XX. favorable

results transfusion abstract, at update oral were from January one-year The accepted which including rate the was of the IMerge year, but this presentation only Phase an to released of described not also that data, X first independence. in top for new line EHA,

Specifically, of TI, with follow-up, XX-week XX.X% additional TI three imetelstat XX responders. months of the of patients patients achieved imetelstat-treated XXX one-year XX of versus representing placebo-treated X

MDS As longer from continuous for the the transfusion-associated risk relief stated abstract, this and in lower TI for one population. represents complications patient year substantial

data the variant duration on this addition, allele new abstract these longer with abstract. data in the next I'll In TI discuss or frequency, reductions to in of correlations patients. VAF, imetelstat-treated describes

of was patients. accepted for with XXX in IMerge XX.X% abnormalities, activity X, abnormal MDS imetelstat. baseline a Phase further cytogenetic The patients cytogenetic also the of enrolled presentation observed imetelstat-treated which of cytogenetic disease-modifying patients XX% either second IMerge patients X characteristic of at response, was an had EHA Of the oral of defined disappearance placebo-treated and abstract clone reduction for placebo-treated XX.X% in versus imetelstat-treated evidence Phase and patients observed of complete a by is XX.X% or in provides

at VAF XX% greater TI that SFXBX, TI compared were statistically mutations. and placebo TETX Imetelstat-treated of and TI, patients least achieving reductions X-week to XX-week DNMTXA for X-year had significantly

at SFXBX greater patients for increases highly significant hemoglobin reductions Importantly, duration. with TI level correlated longer in in VAF and statistically a imetelstat-treated mutation were

The imetelstat lower data may may the underlying continuously for rates patients. robust together improvement imetelstat-tread of concludes biology durable erythropoiesis of the the that indicate TI disease characteristic abstract in risk patients are MDS these alter ineffective taken these of and suggest that of with

along experience be and Patients lower a functioning currently fatigue Moving negatively available overall Further, impacts which abstract, with poster presentation effect as a the treatments. typically life. commonly that MDS be reported also can fatigue to will daily third anemia of severe in at EHA. side

fatigue reported X, validated previously shorter Phase an to not in risk using conducted patient the versus exploratory this IMerge was analysis treated item not XX with measure for in Based of with on patients analysis, impressively, for treatment or in reported the In to greater treatment did sustained imetelstat a improvement patient-reported to fatigue other placebo. rate during improvement fatigue fatigue. time was deterioration with deterioration of score, the meaningful improvement imetelstat compared imetelstat worsen of sustained FACIT or questionnaire, MDS. clinically achievement fatigue rate of improvement fatigue placebo. been placebo. patient in has And meaningful, fatigue of any Also, median imetelstat lower An had the

in significantly patients, clinical not scores These X- provide non-responders, the of had higher improvement responders evidence benefit patients. of consistent XX-week proportion observed additional treatment. a versus This in meaningful was imetelstat-treated HI-E. placebo-treated TI data association fatigue and imetelstat multifactorial Finally, sustained across in and for

Lastly, two at by presentation been EHA. for collaborators have accepted submitted Geron imetelstat abstracts

Phase contribute presentation, imetelstat of from activity in imetelstat lower MDS covers inflammatory which analysis The from profile oral IMerge o immune concludes at adaptive first, risk subset to cell induction immune that hematopoietic with X. The and an an response, could are abstract remodeling associated will TI an baseline patients suggesting be low that features presented the a translational by of treatment.

will highly the conclusion, that targets MS to According features expression in which which CALR-mutated telomere cells. authors signaling, imetelstat be the vulnerable in particularly imetelstat a data and treatment. the and second, hTERT length data imetelstat presentation, demonstrate The proposed CALR-mutated to are clones JAK/STAT abstract that reduces preclinical poster in

that is to I X patients Phase IMpactMF myelofibrosis is to XXX relapsed/refractory enroll Next, pivotal our approximately discuss with study, inhibitor. which designed JAK will

trial around trial and endpoint. the and we visits with only significant clinical Geron first operations sites primary team the overall survival globe, as IMpactMF, as specifically investigators clinical enthusiasm consistently X conducting hear Our the been around on-site MF Phase has to from

increasing groups potential to expressed we've extend myelofibrosis in the JAK population. who also excitement relapsed/refractory inhibitor engagement our advocacy been Additionally, around with have in space, patient this survival the

additional XXXX. an readout the current our potential analysis planning spurred occur of has in we way X IMpactMF lower imetelstat MDS myelofibrosis. to of interim Phase to IMerge the also Under continue in the Lastly, assumptions, for about support risk project in

time Of reflect course, planning actual events is and occur analysis because current it will analyses enrollment currently at event-driven expected. a different these assumptions, rates and may for are than uncertain interim the whether

medical the imetelstat scientific significant to with In on-site teams ASCO to community. and to to planning exchange addition EHA, have at engaging a our related interact presence in strong are directly

MDS our We offering exhibit and clinical medical to oncologists trials space and have resources, at ASCO, for state disease attendees. information other

of Our the Society, in the with Hematology, team of those by Nursing is professionals connect Hematologic broad to such Care Society lower Pharmacy, Association participating touch also a who and risk of of MDS Society conferences, the of and with Oncology, medical Managed American and support affairs as array patients organized Oncology lives myelofibrosis.

in risk of cover of am very his ambassadors senior that broad community includes which our to market as are liaisons interacting the important providing we of with launch clinical Anil? as medical initial as lower oncology overview the completed MDS preparedness well unmet piece I Their the medical needs have be of hiring Experienced an patients the and dedicated remarks planning, clinicians Anil opportunity. and team, imetelstat field scientists pleased which MF. efforts will will and medical an educators. champion the field with affairs

Anil Kapur

Faye, morning, and you, good everyone. Thank

highly in of commercial As Chip comments mentioned, believe the become of potential to lower part a risk and with standard MF. for proposition has care compelling MDS value imetelstat we Geron My the indication, potential focus for significant given in the meeting, MDS, commercial launch. future potential a of market will on lower At today first MF. dynamics and imetelstat our I'll proximity discuss risk the

like across successful launch as U.S. imetelstat. prepare for First, Geron I a we commercial to of commend effort tremendous the would

and market, customer As experience Chip to stakeholders the so a reimbursement MDS seamless the while is imetelstat, to prepare organization mentioned, is drug. for deliver lower that an Geron all we ensuring can broad our goal risk

launch provides to I'd within webcast, across preparation the progress slide of each This pillars early the launch our and like of continue made many readiness high-level teams to preparedness those XX, on functions overview as commercial for who not progress highlight XXXX. we Geron. in are being the across target a

benefits proposition, First, launch, across outlines we key our imetelstat messaging with clinical addition to build in regards conclusively imetelstat's a that trademark comprehensive economic for value to submissions continue regulatory and preparing activities, stakeholders. and to integrated out and

efficient We health supply of and long including activities, also state readiness flow logistic to facilitate our imetelstat continue to make in manufacturing chain and system. time order progress smooth care third-party efforts our licensing distribution through U.S. in lead and on the distribution

market, insights market with generate strategy access from we efforts and our as U.S. perspectives Second, payer providers, to market regards in to preparing extensive and informing middle detailed patient the this channel slide's that commercial have ongoing pillar. are

have organization out infrastructure and enterprise-wide the manner Third, build and our our the commercial we out built aligned plan majority to continuing We to functional of a the sales force in stage-gated capabilities. to PDUFA date. hire are

MDS to launch have lower U.S. understand the we effort execution, a mentioned, our ongoing and As to strategy inform I risk significant deeply market.

proposition. insights which from next this believe Over Geron's research value strong support the few some commercial I'll we share slides, recent

a component as agents risk the of in of patients other anemia, risks, with lower disease elderly the of and to or but and you anemia. the predominantly lower symptoms blood Erythropoiesis-stimulating insufficient primarily in develop symptomatic patients MDS remains to Supportive alloimmunization first-line care, and exposes in the typically like well. and is patients’ experience. many lenalidomide some no correction Lower of cell anemia and treatment early to the MDS, including patients patient of would organ-iron the agents treatment used an as choice hypomethylating MDS stage risk know, present transfusions, important HMAs, patients being red remain majority the overload. disease. of many continues I experience time, of with Over disease First, risk address progress

ESA transformation There risk myeloid significant symptomatic leukemia treatments, life, of red in Most lower poor setting cell of need and shortened frontline typically new therapeutics patients unmet is MDS fail become and blood have receive dependent as this on to a for with frequent patients survival. anemia transfusions, heightened acute quality treatment. risk

need failed responders, Even high include remains who their between have patients ring Treatment ineligible are given and very not or among ESAs. are for ESA who baseline or patients. luspatercept, limited EPO are approved respond is serum sideroblast are XX all which in typically to responses high options patients to However, for may positive eligible last XX and for ineligible levels. unmet also HMAs There months. for patients frontline ESAs

RS- approximately is substantial market ripe be evidence opportunity and in used transfusion the the that red this undersaturated patients in represent key for depicted treatment believe do of risk and durable all options innovation and boxes new innovative patients, the subtypes. segments with continuous as treatments not offer MDS lower lower Therefore, for risk see in and and independence. durable of across will relapse/refractory MDS ESA-ineligible broadly XX% patients we commercial this compelling slide. a able on to this setting MDS imetelstat We and across be ESA

attributes strongly of next IMerge This key the resonated highlights imetelstat more hematologists. slide that academic X community Phase trial and with

levels. to This efficacy, to and regards was with perceived response. sustained benefit continuous Specifically, attributable across was XX-week AE of regards RS units as subtypes, care. and perceive data durability regarded is XX- reduction totality cytopenias. safety, predictable the RBC than strong With TI hemoglobin physicians more manageable of and robust compelling current of of with meaningful Further, profile in standards a TI clinical rates to rise physicians

community use and Given event both, adverse transient across lower of risk familiarity academic cytopenias, profile physicians to MDS patients the their in expect imetelstat the with settings.

also provides research indicates a across benefit perceive compelling in hematologists high-transfusion burden profile subtypes that imetelstat's market option Our and treatment patients. RS risk

MDS imetelstat with of preferred physicians as enthusiasm RS-, of dissatisfaction for over as for communicated would patients from lower In clinical ESA risk transfusion the of hematologists treatment relapsed/refractory observed be improvements level interviews regardless from well markets, studies key current additional burden XX efficacy and with European strongly U.S. with that choice treatments.

the be In hematologists ahead conviction experience ESA physicians the significant increase drug of available of imetelstat with over clinical to options. the compelling considered improvement relapse/refractory imetelstat's durability provide long-term currently more in and RS+ that may noted reported segment, response options. gaining transfusion to would independence prescribe other Furthermore,

that stated be which may compelling currently significantly high-transfusion-burden their patients profile approved imetelstat therapies. opinion option further clinicians a differentiated that bolsters Lastly, imetelstat's was efficacy in over

the XX also hematologists market in conducted research recently. U.S. We with practicing

they responses Imetelstat available approval. as new treatment care ESAs receive them was future in paradigm serum lower important an Our option. how XXX. a may other may due imetelstat enthusiasm in goal ESA-ineligible treatment to potential than would who to second-line new in luspatercept receive patient key who about future for therapies. understand and frontline to MDS, treatment Their asked to imetelstat patients risk and compared potential if upon being strong We greater to setting, the of become is segments, frontline use patients integrated the frontline are across who patients second-line levels be standard in setting expected indicate second-line low-risk EPO the

commercial provide throughout the year. look forward to continuing I to activities insights the updates on and market

Now, for I'll turn over call a the financial update. Olivia? Olivia to

Olivia Bloom

Thanks, press Anil, to refer results. morning, for joining is financial us website issued release on the our and which to for the we Please on today. call everyone thanks this detailed available

with period As higher both higher compared costs in in of financial there the trials the reflects increased to costs commercial increase the costs by X XXXX period lower XXXX to expected compared frontline batches. reflects Phase an in for quarter for line to general additional in X and Phase were period the R&D our new submissions. quarter expenses XXXX The guidance, increase first personnel-related primarily of and the expenses activities. manufacturing increase for personnel-related first expenses quarter first primarily to for clinical activity the for and preparatory higher in same timing and same for administrative XXXX of headcount headcount costs XXXX operating XXXX. the expenses trial in support to was offset regulatory expenses in increased imetelstat same the due The compared in of and MF, trial for costs consulting partially increased additional for higher These

Turning to resources. our financial

March we proceeds in million the had the first of reflects receipt $XXX.X in XX, underwritten XXXX, warrant $XX.X XXXX. balance million offering net of cash exercises XXXX, proceeds marketable from quarter in approximately cash million of from This and As approximately January and public completed securities. in $XXX.X an in

by plans submission launch the of our and believe timing in that the of imetelstat of be potential current approval the our half for subsequent resources fund the and NDA XXXX, in our operating our the financial the on acceptance operating expectations of our FDA projected existing to end Based first planned quarter through risk we and U.S. lower potential of MDS regarding third will XXXX. sufficient and commercial the requirements

discovery We expenses as submissions continue total trials, year XXXX, IMproveMF financial to expect year manufacturing million operating full as debt. Phase lymphoid and and increases inhibitor, lower preclinical in IMpactMF, the launch studies $XXX risk reflects outstanding MDS, well in guidance imetelstat, a of payments X, U.S. of commercial projected interest commercial in preparations research in non-GAAP malignancies The imetelstat to telomerase XXXX headcount XXXX. IMpress for regulatory inventory ongoing fiscal up on potential and IMerge next-generation of for clinical for

of time. MDS, the is response risk of in XXXX The to guidance then we changes assumptions assumptions. U.S. updated low to timing commercial later revised in If plan including based imetelstat those and plans, approval, set to at fiscal potential update in FDA year guidance our in launch financial that of are year a due on

the now will back for I remarks. Chip? closing call hand Chip to that, With

Dr. John Scarlett

Thanks, Olivia.

opportunities you. long a many this imetelstat of experienced believed can pleasure had everyone our the Thank finally Company with whom employees' bring the industry, deep effort strong hope great of see imetelstat I patients work dedication satisfaction. and from of with this a of and career is To over precipice the shareholders. in an teams decades. appreciate our the in of source collaboration potential its have honor well and to literally most and profile for dedicated and I committed drug shareholders, I've as after of commercialization years this for to one associated of support many continued all as the incredibly and remarkable

with operator, Q&A. open let's So call the to that,

Operator

your from Stephen first the And comes question Instructions] of line [Operator from Willey Stifel.

Stephen Willey

guess, in in of X patients little curious achieving included months, will terms the follow-up abstract valuable Just today's months include XX number quick much out follow-up. number that presentations more then, in that a today? incremental updated one-year mature relative ASCO to how a the be patients numerator TI EHA now I And TI the does a expect I second XX-month as just or to that abstract are to include EHA additional of that, then, kind And should threshold? the have data to up across of we trend bit and

Dr. John Scarlett

on Okay. Steve, just Steve, the clarification Thanks. a it's question. Chip. first

were presentations? was would question represented the what -- from about -- I would abstracts? Was much follow-up they by be ASCO what in presented You looking the will the And I EHA incremental those and at that think how that way ultimate be different are that interpreted the question? any be

Stephen Willey

Yes. Correct. Right.

the top you have months relative presentations just to actual an a presumably, cutoff per date today's EHA three later will I'm if abstract. more themselves the So follow-up. have with cut follow-up line curious additional

Dr. John Scarlett

Faye updated Yes. the both second would what was be just the question one-year the answer And TI… these. of -- will

Stephen Willey

whether numerator. -- not just or mature TI,

Dr. John Scarlett

Yes. mature? relatively ahead. go Faye, that Is

Dr. Faye Feller

Steve. follow-up Thanks three-month with will abstract The we we the during EHA. the present be presentation at question, that Sure. consistent what in for cite the

mature, So we the at is patients. don't -- And because we that TI additional time anticipate don't and one-year one-year this follow-up. additional anticipate data that's any time, or any at TI

TI earlier -- just XX-week that the will well. Additionally, are say as mature responders to X- and

Stephen Willey

as all function associated intermediate to potentially this that data impact VAF I'm Okay. is a are how typically and on status, that just I whether an higher could in leukemic baseline the just -- today, a of guys do much risk the trying guess it's patient. you patient about abstract risk risk describing differential effect lower think transformation with intermediate the reductions see then data you a of And at

Dr. Faye Feller

question. Thanks the for

mutation presentation. about baseline to statuses during the characteristics with additional present relation reduction will We

Stephen Willey

could in squeeze more Okay. just I quick for actually. Anil, And if

guess, it suggesting be prescribers in either curious of I the using market slide, patients, prescribers another suggesting luspatercept to on research second-line they'd Just patients. of resequence luspatercept X/X thoughts about in and or your then XX% use ESA regarding ineligible looks about frontline I'm ESA -- luspatercept-experienced that of are

thinking to that Just no that my clinical this data there's about of given knowledge, just data support you're curious about to any how utilization?

Anil Kapur

We could agree more, not Steve.

future I is about evolution the this think market. within all anticipated

think expect we unmet is patients therapies. ESA a I what's obviously, from to would there supportive, heavily clear imetelstat IMerge going how upon need, trial is high is market likely a greater pretty I terms potentially showing us, and patients, first the some that's not dependent to point of very your within space baseline recruit it the positioned in the The very is and after entire that is I the COMMANDS to EPO being think current imetelstat of clear And did mix line, luspatercept with be dissatisfaction on In think than marketplace. to very use. that would with And data the available. itself ineligible position be XXX. also well sequencing, frontline within ESAs, of level the

year, evolved market I would over low-risk expect the and year still the think these we and fully to half now, a fluid, are right understand next MDS space.

Operator

from line Kalpit B. question comes from of Patel Riley. your the next And

Kalpit Patel

in frontline was Reblozyl patients? secures assuming for Maybe just both RS+ The second the the usage patients, column, that one that or Reblozyl RS- utilization front-line this and is survey. under were market in data these more in only RS+ in assumption results on

Anil Kapur

regulatory that full our approval Obviously, for We do on expectation as to not based compared But a stimuli your we COMMANDS broadest -- on this across assume the specifically, of is to label even luspatercept, based And point possible and is their time. ourselves the indications at for data, the how research information. the we the subgroups publicly are the space interactions. of Reblozyl know available this again, both physicians. and was question, full seeing

Kalpit Patel

month, were or before after it survey out data data? COMMAND abstract was was And that Okay. last this the conducted

Anil Kapur

obviously of domain. this are conducted all public that the And sets conducted We this available EHA in publicly recently. survey We aware the we available from very, very information. data with are

So I'll just leave it Kalpit. that, at

Kalpit Patel

last IMerge underlying had question have of therapy? study? start we the you proportion Do then And And cytopenias what types of risk severe sense those the I X a MDS of on did patients Okay. patients for have lower cytopenias exclude before they in imetelstat.

Dr. Faye Feller

With very for know I that It's nature by I’ll entry that number, with the lower answer. question, the don't MDS to requirements of Thanks provide an the We fact have risk severe risk, I they're exact they into platelet respect but Faye. general. Kalpit. it in for you the did neutrophil that can't few. patients, means cytopenias lower it's have and study.

Anil Kapur

do corroborates add in And severe real-world rate essentially pointed on these Kalpit, Faye just that the typically indicate have to the patients we cytopenias. what not all out terms of baseline of characteristics

Operator

from comes the from Joel question your Baird. of Beatty line And next

Joel Beatty

first received this one XXXX. it of cash Does on end potential is in MDS? And from of exercise include through the sales include guidance QX revenue cash The also, imetelstat the the warrants? additional does from

Olivia Bloom

it's Olivia. Joel,

that in lower of risk our future cash MDS. include guidance the sales for revenues sales be from proceeds imetelstat more not does It could exercises. product includes from So, -- from

Joel Beatty

you -- getting just launch discuss launch that of and timing the that A the could preparation at? you’re for you question and ready where kind on next currently of see steps

Anil Kapur

and can first I’ll on So, take as others the well. add Joel, question

PDUFA are all -- be integrated, buckets. with important our comprehensive And most gets assembled XXXX, and So, of very, XXXX that's to be of high an for the imetelstat. launch to drug operational depending imetelstat for our very successfully various launch to summary, preparing this very all and And commercialize regulator we to We, a set grateful in in application. from first talent our team really And enterprise would upon with filing that successful anticipation high things us the functions the the clinical been as aspects to important entity we ourselves the stakeholders obviously, all assigned and we across highlight organizational is our expect those interactions which perspective, June is with for preparing half really that of bring we stated, to indicated economic are extensive as are able continue to and experience. market. with

continue answer, there over activities. take So, go prep the Joel, on months we through the updates provide our I any to away? that year didn't next that we and X can Is launch question as

Joel Beatty

Thank helpful. you. It's No.

Operator

of your question Company. comes from And line next the Needham & from Blum Gil

Gil Blum

one first Anil. So for

put enables do demand, you and increased cash it think on the expansion to needed? Just position if perspective, sales

Anil Kapur

I'll for our believe XXXX, on and uptake has projections and -- through validated our This by that very very we years are have The position physicians. internal ask again with in the this So, we obviously, forecast. market. unmet to pretty in been remains a Olivier well. in It Gil, as speak We, And comment high. as strong unprecedented low-risk and is gain MDS. need data, two we

So should we which marketplace, us. anything else from Olivia, this obviously your expect fast adoption help side? within

Olivia Bloom

asking Is that the to the to basis hand manufacture case Gil, question? cash that that just be have able demand question ensure to enough spikes the curious, the have that and the in we you’re inventory? we that inventory on of

Gil Blum

centers increase more more you if sales your is No. there i.e., exposure, demand? The reps of to flexibility is question or have whether

Anil Kapur

Yes.

as are we to even on Joel, or all launch. for we obviously, we In so -- our expect well, 'XX across produce at day in either also competitors national in our that planning Gil, -- of which question share to data events. on planning, the key depending our be that from is U.S., results as sorry, for we upon second of So indication the voice 'XX, centers, for coverage myelofibrosis, expected And are one.

present And be the assumption. indication And long-term are first those indication scale of our all we the part would we our for as planning appropriately well. fully and expectation is, for

that question that answers So, hopefully aspect well. the of s

Gil Blum

And you. Anil, still I since have

So I touched this, does sense? on know makes you in how survey, does luspatercept luspatercept your -- -- how but

Anil Kapur

I these to I question best think my directional. that surveys I as take did all before. answer

likely is be unnatural what think an is to I clear very it's choice.

new all with treatments, know, highly I are think we as available. mechanisms, newer differentiated become effective when which

that second-line well. at agents for and When a well frontline communicate that new preference come clear best dynamic. we would in do to a ineligible our within start physicians the very adopted need a patients indication the value imetelstat I fast a the proposition at remain be that ESA for heavily extremely preference look activities, every unmet what setting set, highlight regimens would our research, that pace front think encouraged each and expect to irrespective it we the and appropriately. would I and settings, And tailor marketplace. of for across the high, to as what's data We happens as similar of back in high would these expect clear one line, patients and I

encouraged we lot So, are but this there expand. and evolve a to I think And more will is space come.

Dr. John Scarlett

Chip. it's Gil, Hey

call. questioners since no the in the market really I a I'm -- physician. make But add this early the I'll obvious of the other said. evolution a on There's undergoing what actually especially comments some would change. for of So, accounting sometimes, And the taste would echo I from Anil

very much findings. than very half focused, were get is this here. these these see more full drug, by we we're of we as -- The own think encouraged on of course, of expressed -- the This how today. all our nuances glass, and preferences I different very

as evolve. elements It perceptions -- will more will put evolve these by were in Anil other it think really evolve. exhibited we the of But as beautifully. commercial by as space that very surveying value physicians. encouraged I data were the It guidelines both really all

Dr. Faye Feller

unexpected that I'll I'll like, patterns therapeutic the what this and even just tried lack in is survey, quick have to I give from if Faye. patient them think of providers that so I options need just unmet again. one really I'll that try treatment population It’s they're add it comment maybe the result are what speaking before, I more these the it

Dr. John Scarlett

It Yes. the question. happens. Thanks for

Gil Blum

Maybe last on here. a one cytogenetics

had even diagnosed. a who you because has the that need already general First then data if up working of with chance very data I is have I they're responder? I still diagnostic Phase just early remember patients I a you put is on of your on a significant to what X could population, for MDS do predict Not in all, saw back but study the that for in higher potential here then patients this there being to IMerge. of analysis have, lot you you is, And any a consistent that. which when is question pretty this

Dr. Faye Feller

the for question. Thanks

inhibitor, subtype imetelstat the that I a a think of of broad one of range telomerase as benefit distinguishing characteristics types. mutation is can obviously, it cytogenetic types,

the I -- a inhibition nature anticipate that's that characteristic any imetelstat our signal. and we think telomerase of of I of that a on. don't mutational target the one So, in cytogenetic And signal will a ever see inherent toward that's selectivity focuses or

Operator

from And Sachs. Corinne line your from Goldman Jenkins the comes next question of

Corinne Jenkins

looks about lower point planning to conversations questions what And billion of market how of on with? think us. that you per that? is which And couple curious the launch you've out, date you're Is $XX,XXX A about I'm risk a laid MDS addressable roughly price with if to had underpins month. particular assumes from It the $X.X expectation? that any they about price payers in

Anil Kapur

question. that take I'll Corinne, So,

have I'll as one we PRO would through proposition, importantly which expect on bring is value pricing even mentioned, anchor. clinical, favorable at focus points, economic Europe last the So oncology, continue and for norm. much U.S. now us, it's MDS, the few that much we consider the is to favorable analog low-risk in launch. at data us labels. point the drug approved are But to best obviously, price price I highly, In think within first, we the strengthen we And when we known MDS, currently evidence these highest expectation the and extensive this points, interaction payers, years average And And pretty both within and and as the low-risk luspatercept. to the are that space. our the is And drugs. our out at And -- our both continue at those you with to differentiating. approved their our for end highly over for for interactions. data, dose specifically out our look is pricing of pretty publicly

Corinne Jenkins

maybe from one another And Thanks. us. then,

whether Just how and launch color it a plans? go to partnership? when more get the U.S. or filing lines ex alone we should commercialization through you thinking And about as to time expect plan on you approach are you U.S.

Anil Kapur

guidance half second in still filing remains the the So, European same, is for year. our of which this

mandatory, appropriate to in steps is especially the with pretty payers, key taking markets today. We engage which are

make decision year. to the a of is the expectation we'll second point time. guidance around final provide half obviously, And that Our at European commercialization in strategy in

Operator

now for back to Ms. some over closing Aron call remarks. And will I the for we final the have time that is all turn Feingold, questions.

Aron Feingold

great so everyone joining Thanks you us to to during a for We look exciting very today Geron. much date. continuing keep for Have this very, day. time forward to up

Operator

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

may disconnect. now You

Geron (GERN) 11 May 232023 Q1 Earnings call transcript