GERN - Earnings call 4 2023 | Geron Corporation

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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 Fourth Quarter and Full Year 2023 Conference Call. [Operator Instructions] Aron Feingold, Vice President of Investor Relations and Corporate Communications, you may begin your conference.

Aron Feingold

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

John Scarlett

becoming profile trial, treatment XX, Thanks the of review everyone. most be commercial XX, will Thanks, the date a we for clinical regulatory thrombocytopenia review underserved show fatigue a half lower-risk a early on genes. critical safety Aron. to a process, rate expected trial treatment scheduled today.Geron's we next benefits supporting short-lived analysis with important is has the imetelstat lower-risk An indication Phase XXXX. XXXX. way in and patient-reported these option patient of hope our transfusion-dependent provided a and a the significant imetelstat interim study execution variant treatment in durability review result transfusion-dependent the with of neutropenia, allele in mutated MDS blood our March well-characterized notice similarly from the indication, less anemia highly generally progress frequency currently and of company. the and and compelling publications approved believe for Lancet, X IMpactMF NDA With XXXX.In IMpactMF expected XXXX believe PDUFA that is of relapsed it joining first be MDS, what if the Good myelofibrosis. program, and of cell it's by robust morning, FDA X this across can to for of ODAC populations manageable transformational and for commonly in assigned recently June part The refractory that reductions become in of focused of in of has evidence a patients JAKi for and authorities.Behind TAM transformational we for to in lead is thus prognoses is be TAM, a Addressable and indication including across data an XXXX, lower-risk a steps interim If completed in EU dismal analysis $X representing for for patients regulatory each is commercial with expected for with who also independence expected on MF is $X.X transfusion subgroups MDS and overall is survival as in the XXXX transition the analysis only the red Phase a unprecedented patients significant and endpoint. relapsed/refractory these addition, trial, include option for for X plan could billion MAA with MDS important indications primary lead in or positive, lower-risk Market, JAKi MF. same for the an have We're pivotal us in multiple held high U.S. MF final XXXX as Total treatment of or imetelstat imetelstat and relapsed potentially throughout two MDS. and has for the transformational paved XXXX, transfusion-dependent first our of XXXX of approval today.Our IMerge Phase the attributes opportunities which with prepared for clinical as areas a and addressing imetelstat need.Additional unmet in represent MDS outcomes response unique survival refractory clinical The combined billion imetelstat differentiated we

to Given the also and this completed upon to expect market and in broad transfusion-dependent in commercialization, potential U.S., imetelstat transfusion-dependent MDS, activities access ensuring by FDA in multiple in self-commercialization this very imetelstat launch prepare substantial our potential its in European partnering, lower-risk the we commercial and amid need of have in we and this reimbursement update evaluate medicine. approval lead indication including occur for XXXX.We provide year. imetelstat, options launch long Geron, the with European the the Commission an in of unmet Europe self-commercialize to prepared to MDS, goal later deep expect to lower-risk are important year.We launch to able our Moreover, for approved be middle a or opportunity is would strategic for continuing expect our if be lead

which, a MDS lower-risk commercial important enable financial and expected resources product XXXX strong ifferentiated of and near-term and transfusion-dependent planned ended fund the update. excellence plans Faye? lower-risk and a MF, in $XXX of believe approximately in cash U.S. and fund transfusion-dependent we for clinical quarter employees, our launch our in resources, to position our in that, to turn to relapsed/refractory on Faye of puts regulatory strong milestones execute creation.With over us candidates successful very the into our experience have us MDS potential the million for call the operations available value third on opportunities and our a I'll current expect a with the based Lastly, position we will XXXX.We

Faye Feller

mentioned, on transfusion-dependent FDA the focused have for with review to response treatment or deeply to we ESA. call.As for morning have the regulatory in good and failed who lower-risk respond our patients Chip, anemia for under ineligible on lost EMA processes are which MAA, NDA, Thanks, of and and to are everyone MDS imetelstat by or the Chip currently are the

an believe opportunity reliance to followed last by in medicine XXXX top-line on experience. a complements We March results part quarter from our that review, disclosed, that of IMerge the imetelstat with the on that additional enrollment be excited relief meaningful trial the to our reported benefit was at growing these clinical to as FDA PDUFA presentations subgroups date and to of the have deep January imetelstat clinical have at in have and We've of believe consultancy group historically prepared compelling We XX% of the is the cell peers, offer be transfusion-dependent and MDS confidence and we chronic the with well in ASH. January now notice response, working difficult FDA lower-risk with particularly differentiated, EHA of from am virtually effect XX, previously new as scheduled could personally in Phase profile imetelstat been a X XXXX. across feel year very patients relapsed/refractory of ODAC Phase the of an and very field, MF. the months a study in as imetelstat number This way in lower-risk imetelstat last past has earlier study these of conferences, attributes and validation globally high powerful were in experts RBC-TI trial give transfusion-dependent us for analyses IMerge with the including As we MDS from reach an practice-changing XX, Lancet this and year imetelstat trial well safety providers the continued to June for completed hematologists expert NDA the provided importance possibility which of our respect of December, assigned potentially body patients this of from a at many the manageable consistency also response Register data scheduled to of regulatory ASCO for XXXX. pivotal lower-risk XXXX, action trial data, with XXXX. and MDS the what transfusions.Turning important treat.The in rate, I excited within in-house with for strong X results of to to MDS.As to durability our been other On a Federal ODAC. blood the November XX, as patients.Our it published were positive held discuss readout results of

analysis of XX% enrolled is planned this will important of to of patients are as Phase analysis on look We continuing in study.Lastly, with the first keep patients a study XXXX have frontline updated to died. of in A therapy have ruxolitinib over imetelstat we final expect when XX% interim a enrolled in X also first continue in the died. occur combination with the patients myelofibrosis. XXXX, planned when the approximately half evaluating forward you We to an expected which half

cohort and the for this regimen main ruxolitinib is in Safety frontline potential the imetelstat, or who four IMproveMF, of by to in to as MF as SET, cohorts determine Team data. disease decision second Our the reviewed safety unanimous we profile the activity escalated well study goal explore setting.In January study, the to dose of a third study's a the combination XXXX, of following combination known the as Evaluation

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

Anil Kapur

discussing launch, most approximately are provide up patients who lower-risk and very anemia outcomes. need MDS poor treatment the are disease and need and survival supply treatment effective current risk are are need significant effective preparation subgroup.RS a refractory affairs up are our need populations everyone.I and MDS therapies are such XX% Approximately transfusion more Geron. potential launch underserved the and a subgroups upon our options. remains There XX% are progression ESAs are look Long you, at negative trademark we manufacturing brief time approximately market a morning, to high launch unmet to high for and unmet patients of network of we vulnerable and U.S. particularly update into lead not patients XX% greater on for treatment lack of suboptimal global patients patient no fully forward in patients complete. key These indicated onboarded in burden plan are market on the across treatment make lower-risk relapsed of about ESAs. readiness name, for options.Moving launch the of once the activities approval. ready MDS eligible multiple first also RS commercial launch now to on population months support or to for by clinical Faye, a on available our MDS U.S. patients critical preparations, make be in U.S. to highly There brand have imetelstat securing just plan. we'll in positive and lower-risk lower-risk completed a activities date our RS negative In see addition, X.X then experienced represent of our underserved away, integrated and they providers.In good significant that have distribution with options. medical our transfusion-dependent PDUFA to have Thank an update where finalized and we and we commercial team a unmet patient as

and plans processes commercial and with key all integration We are commercial the and account recognize reimbursement revenues transition access, early systems business our refinement stakeholders.With January onboarded report recruited. were in with and of regional manager field of and continued roles towards continue payer, regards to marketing, to engagement adoption team, Geron being directors to the a and company

onto We onboard we second team excited the sales talent and first XXXX. commercial the in I'm expect across recruited by the force the quarter of caliber and of the very organization. to have

imetelstat been that, to therapy launch they now the teams operational have approval.With for part are launch patients innovative Michelle market in the cross-functional and are opportunity a bring over to to excited multiple I'll our and the FDA potential Our oncology readiness expertise launches.We upon update. U.S. of experiences in and this call financial deep about Michelle? have confident to oncology pass

Michelle Robertson

FDA our XXXX had and from the primarily and were teams.Our the expenses subject $XXX.X equivalents, million, $XX.X and R&D medical employees will current subsequent compared expected potential The employees, to XX securities everyone.For increased proceeds ended periods ended and third XXXX, that for warrants million primarily NDA from in facility of support $XX.X of the sufficient the together XX, months outstanding the FDA of compared December quarter available between some submissions our review will and and in X imetelstat, and we of our and months our Phase Based million compared in million same costs months are December cash which X potential for $XXX to million the loan million $XX.X there this morning, increased in year million headcount company readiness our year X we we expenses project full At IMpactMF, good marketable were million the and now $XX as regulatory IMerge consulting for investment exercise end from transfusion-dependent will please under financials, into $XXX comparable commercial $XX.X will related same supporting to plans warrants ended December respectively both million.Total the current is XXXX. of be attributed million support operating expenses external trials, $XX.X XXXX.I respectively, and $XX.X believe periods. XXXX G&A million and year, X MDS.G&A and $XXX and our December lower-risk to million to XXXX million issued expenses At periods Chip. approximately XXXX XX is I the personnel affairs XXX Thanks, operating and over our of the the expectations increase and and for $XX.X of commercial quarter grow X.X end cash cash, with operating press imetelstat. and full for U.S. in clinical a of from outstanding in million we of over regarding the $XX.X the in were XX the turn and potential U.S. commercial potential on commercialization XXXX, primarily and receiving expenses XXXX year were approximately expense activities. The proceeds XX, QX is imetelstat under million. projected the end XXXX.Expenses refer increased the release prepare for full these of XX, the have review to are U.S. manufacturing that resources, $XXX.X million approval year. to the Chip? on to highlights warrants morning Anil, timing $X.X revenues which website. $XXX.X million to for and detailed XXX XXXX, sales XX, our increase and XXXX, and is launch, the back call approval is support projected headcount to to and imetelstat be now the funding operations currently to by to

John Scarlett

Thanks Michelle.

medicine. potentially represented expect we're is Today, drug into the For telomerase we many in and value commercial line keeping is which We'll XXXX to We Geron, on shareholders patients from questions. scientific open Operator? half carry MDS. our culmination and of has and progress alike, to enrolled we're XXXX as excited our on date multifaceted X these first-in-class XX% powerful IMpactMF offer Inhibition the the is successful goal a transfusion-dependent a treatment to we're a option first and you of updated programs in of with progress. we by the momentum a X.X promise journey, to trial, we for an for now to opportunity of which in year the to commercial look potentially translate development potential which analysis robust company.In and the life-changing PDUFA which XXXX. becoming track the forward months a telomerase of our lower-risk our Inhibitor, for important believe believe Phase and believe We transition addition, away November this the interim significant patients just for

Operator

[Operator Instructions] Corinne from (sic) Jenkins line the of Your question Sachs. Johnson first Goldman comes Corinne from ] [

Corinne Jenkins

it. program? as and view from with you imetelstat How us, what you REMS box from under likelihood importantly, more approved implications scenario? perhaps you follow-up And black the the then, to warning either either commercial a perspective see do a characterize could a one Maybe that would and/or

John Scarlett

Corinne. Couple of there, questions

First of going and hear this will. over to you're all, over, everybody

to close once, reasons the going events. really we're we're say on not ongoing just of I'll for obvious that milestone regulators, conversations and to comment these So, getting with all

just how safely population. used and me will that its all REMS think too in I a effectively [Technical feel say, but little very warranted, I Let ability Difficulty] it's this or predicting a that is don't don't go we target either perspective, think black our warranted. to is box that a and be for us, from speculative of program maybe

Second question... part of that

Corinne Jenkins

if be implemented. to commercial was The it implications

John Scarlett

in out I'll of current stay speculation, Yes, that I think speculation.

I from all never on warnings black these our We're a it Again, or how thing types is we forward it that either perspective, on that kind hope. are contraindications, good speculation. all the, think everybody again, gets together. certainly nuanced of depends or to understands issues, issues. those depends but boxes comes focused when beyond put from refrain REMS of I'll

Operator

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

Kalpit Patel

There AdCom from the on positive imetelstat. of was overall a additional the an letter requested the is, of have studies the for as letter the question you members independent cytopenias topics safety such for maybe the submitted the for regarding imetelstat. conclusion to hepatic independent evaluating was guess The all any I But other safety group that ODAC by assessments before

John Scarlett

say very liver scrap And to in very, [indiscernible] injury, aren't of hepatotoxicity all of did ago. have members hepatic were have people think [Technical or committee, experts in trials was relates to experts liver of going convened we That at every many of aware our at decade known scrap a almost it. imetelstat wonderful form et industry, letter any every to clarify information forward. on oversee I evaluation group they quarterly a liver, Difficulty] looked had them of drug-induced And to well engaged in or safety. cetera. meetings. those They case I job. We way, They're they legal the the have for of shape we who looked That Well, Agency. by that information sent to

there their so simply read And safe very the it drug docket liver letters reaffirms in a a perspective. people from beliefs there's that can so

that. interest we'll at a aware just and area where really especially ago. think are well many people that That it of of I that's interest So confined it a of came is leave kind decade from, from

Operator

of Your line next from from question the comes Stephen Willey Stifel.

Stephen Willey

it I'm if sure just guess, able to trial more and be this, what the the a that cell as you'll Again, label, be speak can to bit was? platelet the you think trial? I product frequency than not remind you you requirement what in of would monitoring count was expect potential monitoring in but us And stringent a about IMerge to

John Scarlett

I say. because sort know, that that these it's makes for are comment and whatever we facto studied short-lived at as us course think of guess know I standard. if unlikely that weekly managed, monitoring I to be on really well you the I them de by frequency several is and But ability think labeling to given but of in the do of the the that was won't interrogate as will way. I I se, sort looked should cycles. that recall, was exactly, you manageable, not And first regulators which, Steve, a where it think in go I cytopenias indeed sense. trial the per And

going I facto think and So safety from the de expect perspective. that's what I forward would a standard

Stephen Willey

guess, obviously whether office? of you weekly marrow, know, counts, it's are mean, them you and whether a at I of MDS know doing cell what patients, proportion dysplastic they're And lower-risk what home, but already it's do do proportion Okay. I in have these heme

John Scarlett

it dysplasia is know and own the of don't kind and interesting they what on journey what is. It's marrow you an would to I their as are experience that. answer depends of say that forth, say, of question. I and in the the level where so kind their

that we Difficulty]. meaningful receiving and were the associated placebo placebo therapy the cytopenias, is who, in even regular you patients they be probably hand, is monitoring also that background showing As the associated saw think known with though and patients with these have did on different I are cytopenia other more take to products whatever arm, allowed.But [Technical simply other

up And started, is course how whatever get physician those be my follow this that of be out the will patient's on would carefully, it you drug, the carries kind of a sort hepatologists in start how So any most the says over would decide drug it treatment would just sense. ultimately, all that then with to and of labeling the that frequency something new guess very to when makes included trials.

Stephen Willey

obviously the mean, of of Okay. kind not there's for still expanding, runway the Maybe necessarily regarding into here picture investors narrative just a broadened but additional bigger development and I question. this amongst exclusivity imetelstat indications. kind some being ongoing program is it's

curious, for think do R&D designations? Phase IP thinking so, additional of you online program out just you the carve quickly, some about kind maybe drug. could in in these interested I this guess internal of terms orphan confidence do bring are opportunities how be you're drug X reflect these Would And or studies longer-term that just the your

John Scarlett

Sure.

then IMproveMF just get are round Did your referring that? you I AML think to and be I question about to clear, the So studies.

Stephen Willey

Yes. Correct.

and study the of combo Rux some other Phase X. the So just

John Scarlett

Sure.

So IP drug, whatever company a I of are. on of it's think positions regardless every developing incumbent the the nuances

we of combinations, utilities study different I think new study we drugs.

being leave we for mean level. this, little kind it but to I sorry And at a to about of preachy be, a don't have high

ways that of we when they really number written were There ago pre-clinical not these now. question that we experiments looked about, lab really series we a is intrinsic that the on whether very and a a or were that of you as of the The to different exploit a years some know if Difficulty] scientists And of become benefit think know. think example, at good is people Rux for there inhibitor done patients, basis telomerase be are do whole there cause the with of [Technical to derived were to good the interested. I the cells myelofibrosis inhibitor, that's clinical see treating JAK if some in with And damage.And any we end in and Difficulty] you see what outcomes. that you of then activity you is up ultimately that [Technical against if malignancy transformed after can that, Difficulty] of which chase with higher do depletion case, actually you come see this the a surviving you [Technical a and stem of inhibitor, cells. if longer that, telomerase and get living you of in sort [indiscernible] proportion also a animals have imetelstat,

So we this to drug, key on would, the guess although upfront going into their If else and the start for that I study necessary is study. do people some start us A, start own, patients. that have we it to to ultimately, know to think we can do of it's world helped efficacy, with C, all it, a frontline that. study. this we to the actually do that ultimately this. somewhere able in will work better was B, we predominantly and control to we the And are some have be we've anybody because, don't hope safety improved do this people to go than we

are AML for about drugs other actually horizon same think patients So rationale. also to the sake the it. I again, options. cross preachy that There hope terrible with but we'll AML. these disease with be, in and that, patients of experimented that a have very the sorry The kind that's few is I

something goal interesting. in really I intellectual is completely separate protection. not are story reasonably and you that's you plays ultimately as innovative, Our think patients if a innovative, property these for do one That file as which actually out

Operator

line [Operator Company. and next the of Your comes from Instructions] question Blum Needham Gil from

Ethan Markowski

is in before, Ethan educating have on Markowski space? you'll community future do could physicians touched think on have thoughts for any much ones, on I academic this you on this approval? MORPHOSIS do on to managing And at know landscape? extra spend myelofibrosis you've This cytopenias Gil. from how assuming data but versus And impact any you recent how the development the then ASH effort

John Scarlett

tailor-made for I think those Anil? are Kapur. Anil

Anil Kapur

Sure.

cytopenias very had the as extensive setting. with low-risk both drugs have And for and reminder HMAs, within just for managing have community are academic period a particular, len, them community heme-related effects providers. we patients. they and a et long predominantly have at successfully experiences is they as point in they prolonged of practicing which for treated with and everyone, something cetera, time.With managed side So to to received very us as really with adept no HMAs, for is imetelstat events. the cytopenias. and discussions of provide and such receive favorably And tell myelosuppression is what deep is Physicians hematologists. MDS of areas are they the clinical are important by infections these also that really bleeding there that's consequences importantly, associated hospitalizations, we is X. the And predictability with this cytopenias terms the when fact away also in action, finite The context on mechanism of cycles of typically favorably cycles the and And which duration tend go by X

between we training They toxicities. on their of practice the So community adept myelofibrosis, do and think experiences.With which the also terms of regards are in and heme not their with academic differences hematologist I their much is versus to perceptions fast-moving. this also is question management an see the area

world, landscape.But positive, are from obviously and a experts, to that's within with to knowledge, if the the largest refractory is and patients patient extremely be in JAKi. the to happens space. will what population is be my academic best our myelofibrosis We leading study really the physicians, every reminder to KOLs for we only relapsed that effort, BCL-X inhibitors This at of myelofibrosis X looking is underserved terms for and rapidly in in going well adopted is feedback with myelofibrosis the the study, the patient is of will BET entering and population survival Phase which a is wait transformative see the that it

So stop here. I'll just

Operator

question Beatty Baird. from line of next Your from the comes Joel

Joel Beatty

many or the any provide can you part For are program, quantify access updates how that? patients early of

Anil Kapur

take to that? me Chip, do want you

John Scarlett

Yes, Anil. ahead, go

Anil Kapur

the is the So, We not that's But within ongoing. that et cetera., provide on a clinical do space. projections updates Joel. study study, enrollment,

Joel Beatty

cash And that guidance? the the of then for going XXXX, assumptions what guidance QX sales runway are into into

Michelle Robertson

was Sorry, mute. Joel. I on

any shared haven't sales revenue or guidance We guidance just yet.

Operator

And we over for will answer call end our have now Feingold Aron final turn the reached the closing some to back I period. and remarks. question of

Aron Feingold

look Thank us We today. you, in and keeping much interest appreciate joining updated. Be to your everyone, so for well. you Geron forward

Operator

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

may disconnect. You now

Geron (GERN) 28 Feb 242023 Q4 Earnings call transcript