GERN - Earnings call transcript Q4 2021

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Geron Corporation Fourth Quarter Fiscal 2021 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. Olivia Bloom, you may begin your conference.

Olivia Bloom

everyone. afternoon, Good Geron call. the quarter year-end and Welcome Corporation conference XXXX to fourth I'm Financial Chief Olivia Geron's Bloom, Officer. today joined I'm by Dr. John Executive Scarlett, Officer; Chief Dr. Geron's Chairman and Officer; Executive Aleksandra Anil Officer. Strategy Geron's Executive President Commercial Chief Rizo, Vice and Chief Kapur, President Vice Medical Geron's of Corporate and and

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

John Scarlett

Good Olivia. Thanks, everyone. afternoon

in we of I'd even to believe XXXX why treatment be discussing accomplishments to of malignancies. Before we putting and XXXX on before hematologic drug, a in transformative potentially moment can into spend reviewing like accomplishments significant especially such beyond, our those the build imetelstat how a context and plan

please. slide, Next

oligonucleotide, and enzyme enzyme transiently of expressed normal continuously their proliferation what is unique length and you In by stem discovered malignant during this of allowing potential or telomeres for the substantial where so value proliferation. Imetelstat first-in-class. hematopoietic in a But the low-risk contrast, blood mechanism that action is ends adds This killing that strong continued is many hematopoietic proliferation. inhibits expressed. an cells to limits leading thereby cell telomeres telomeres is Phase disease-modifying induces in of It uncontrolled and cells and apoptosis Geron progenitor from of that As of know, those chromosomes, and activity. cells. selectively malignant expressed exciting thus This and cells, malignant both production. trials to telomeres drug makes MF and in X cell very stem evidence data is MDS of provides continuously developed

Next slide, please.

that summarize of Here, activity X Phase evidenced elimination we cells to in key stem reduction telomeres a and depletion abnormalities. engagement by cells malignant molecular and the of evidence. In marked marrow telomeres led cytogenetic trials, malignant by progenitor of both the bone target imetelstat's as of and

in biologic and modification Importantly, care the for imetelstat meaningful evidence in anemia bone depletion activity in allow MDS of and to data, in marrow as improvement will interest we reduction benefits correlations of hematologic fibrosis in community both the in those keen expect malignant time the clinically first our advance as through and clinical as well MF. lower-risk the the refractory in are X provides trial Phase which correlation overall of survival. of These of disease responses significantly which in MF, of patient with strong imetelstat, potential was telomeres reinforced is marrow effects as the MDS such cells with reduction bone

Now happened let's in XXXX. talk what about

and our the depth, in important submit the trials patient unmet expect in readouts. X imetelstat designed expect These and to our IMerge And intended and observed transfusion to slide, of ongoing registration-enabling lower-risk indications. refractory for assuming to In A trials critical lower-risk I XXXX, come Phase achievement our well X TLR see in an Next breadth as focus as lower-risk two get opened X approval, first we TLR, efficacy commercialized in made results we NDA durability high wait we those of MDS was needs and we are enrollment. safety those independence the MF, of confirm XXXX the can't In being XXXX. MDS address results XXXX. top next to sites to top-line in then the trial first line be completed Phase X trial, to of key call early involved MDS XXXX. same months IMpactMF, please. XXXX. as lower-risk similar second parameters, milestone The trial are progress and X with advancing Phase enrollment Phase October of medical safety early our trials in population, toward also Phase enables in half data. MDS, for that what those within be be to XX cannot That XX% as the patient If we half of in January enough. the for fast announced in

We clinical provide in strategic also additional IMpactMF value call. and designed later in Aleksandra regimens. development use costs started the detail are potential several the programs combination rest broaden to new modest more indications initial that imetelstat in the will of and programs only imetelstat's with high on

contract Finally, of by populate by preparation plan. imetelstat commercialization several first in into are for time process lead this modules to NDA. already our We've we began manufacturers items a milestone-driven company. utilizing commercial Geron key a stage-gated of the validation and commercial long as transforming stage engaged NDA, for in such doing the beginning batches comprehensive our XXXX, We're of

needed Officer. affairs, annual an significant assuming Europe, two internal indications, in the and began MDS including a to MAA Both approval U.S. keeping market and in on commercial also program peak access Business potentially regulatory and a have our lower-risk generate key submissions. in focused time launch program to countries submission hiring EUX greater We commercial and and NDA are for revenue Chief such an in activities organization, a to of These MF medical refractory lines support $X supports of aggressive of XXXX. areas than billion data executives TLR ultimately the U.S. the in value. the the assuming the very potential are Many

update and further hand potentially As our could to call parallel in we're structures mutual to Rizo. regional partners. a continuing our and Medical over commercialization. will which These of and an imetelstat exploration our to clinical Alex Officer, interest, I'd development like preparations efforts. relationships with Chief the result, provide of appropriate with you now Aleksandra accelerate potential possible with commercialize investigating other deal imetelstat, include actively

lower-risk our Corporate his and share Anil expected Officer synthesis of Head Following imetelstat Commercial Kapur, Chief and of the that, will MF. in both of Strategy, role refractory with MDS differentiated you

XXXX make fourth will guidance the end year-end some quarter comments and call review I our for and Alex? final of provide about Financial the Officer, Olivia financial our Before XXXX. upcoming at milestones, Chief results Bloom,

Aleksandra Rizo

Thanks, trial Chip. TLR In our as This for X trials was and refractory focus Phase MDS sites XXXX, the advancing prepare complete trial. we Phase will lower-risk our focus MF. for on IMpactMF two IMerge in and continue the opening for clinical X in XXXX

Next slide.

are such year, the executing Phase XXXX. enable database and to X in and activities early as timely ensure of clinical team data reportable January rest today IMerge concentrate lock will line cleaning the For the for results on top

clinical deliverables patients significant parties our achieving hands-on and of the coordination organization amongst sites planning, requires oversight internal around with and Given the by team. these world, numerous number

we internally. review have for In at and clinical adequate ensure addition, and management implemented our to CRO medical plans resourcing operations, data

but numerous the also the submissions. for not preparing is outputs investigators results. will eagerly the statistical team and IMerge future Biostat seeing for study are that line regulatory needed be Our a analysis to top for We forward TLR our and looking from only

the two currently and two patient open we this follow-up. visits have sites events, site a to impact would Ukraine. do that do We two and In this we this On ongoing At the IMpactMF, this to we overall trial this to to you, as comments to impact in two like which in is on opened trial. make site all and on to Given MF over at not currently these visits. the endpoint. whether X or enrollment, remaining conflict to we're is clinical situation. I closely We in expect I'd the our global by like lost that will we XXXX. expect patients the at to one XXXX, current Like patient be is these close know patient few an due end of evolving In patients are sites not Russia, monitoring of of Russia of conflict. in sites we sites have patients this XX% time, refractory X clinical population. the Ukraine Phase a of selective the open only planned know using MF the and primary survival OS the trial, timing patient TLR Phase to to everyone only remind second

For are and we Ukrainian this patients screening Russia, patients In trial, randomized sites have three there two four participating. across sites. no in

that and sites currently this enrollment OS current the on occur expect the arm, occur the enrollment at treatment for However, for Because analysis interim at events event-driven, median these interim impact patient uncertain in analysis. IMpactMF planning which XXXX. conflict of have determine around of treatment opening are the will or each death for analysis timing we the may rate we is the assumptions new Under open and sites.

that If be will we Phase if X MF As refractory IMbark number imetelstat complete events in treatments the differentiated in these will refractory of likely then interim in the as At will or before as of criteria and the for confirmed events could imetelstat is occur these enrollment patients. approved change paradigm we the registration this occur enrollment in trial, patients improvement interim MF period. analysis which met, as believe our analysis, X can early in other result, a could Phase be IMpactMF statistical is could in throughout trial, OS the conduct treatment study currently OS to then we required MF, in development the imetelstat-treated data from the expect support the for prespecified XXXX. strongly the observed accrue

for dismal treatment lack you longer inhibitors measure shortly, OS hear respond of as to significant no their options. of from who JAK especially desirable treatment the a consider patients, of As patients to MS key will and their prognosis due for Anil benefit physicians

Next slide.

Moving as to we Phase the forward new X on studies. November the to In expansion. trials part new we announced three start pipeline programs of of from our our look XXXX, last

clinical ruxolitinib MF, open enrollment the X to in with Phase of first our combination track IMproveMF, imetelstat XXXX. remains First, half of on for in study in frontline

modification being boards is reviewed disease. protocol interest MF and patients earlier each potential to by clinical site. The at is from investigational their imetelstat to disease the approved bring review Our of here local in

higher-risk MDS in of directly like will second the more driving sites evaluate expansion XXXX. of the studies and and AML the cells single of highly increasing to progenitor Due combination effective the studies The affects current these than initially participation, half a in with as of called IMpress provide agent could for action extraordinarily heme option mechanism malignant start Our planned, be the imetelstat and stem in AML of patients. for these therapy. we to and and for and principal that to the studies an treatment investigators request investigator-led a these of new treat enthusiastic. an continues TELOMERE to imetelstat standard are malignancy both difficult care expect disease studies

ongoing. malignancies. done allows imetelstat's This the malignancies experiments to preclinical addition being future. MD the evaluating new us new work if imetelstat treat potential indications open is could several we in preclinical which beyond lymphoid explore to have these to use In work of heme The myeloid some positive, at potential studies, Anderson, also

of We to data preliminary experiments the MD at from at these XXXX. end continue expect Anderson

the is different inhibitor details. have the area Our discovery continue the lead once more compounds final into program. characterization Research compound is and identified, pipeline new next-generation for the expansion will research we of TELOMEREs

also only activities imetelstat sets All busy for to XXXX Geron, and not year, rewarding but of for up patients. and these be a

over will hand the I Anil. call Anil? Now to

Anil Kapur

in Alex's closer prepared my and and remarks product to good a results. can Alex, In that we profile the of role I'll in drug patients how into insights will play lower-risk the in highlight imetelstat's I expected afternoon, Chip's both treatment I'll believe IMerge fast the differentiate indications. evolving line everyone. first myelofibrosis as We that, provide excitement top the get After meaningful today, in imetelstat MDS market. market. share Thanks, the and this

addressable As describe, patient I'll large opportunities represent these for populations significant and indications Geron. commercial

patients, to MDS, practicing attributes as imetelstat's sideroblast-positive which slide. received ability of set includes imetelstat’s and the Next In independence. has product transfusion been sideroblast-negative lower-risk profile durability broader favorably hematologist. both include ring of as a treat identified Key by well subtypes ring

In hematologists and for in well disease unique service. our potential addition, resonated mechanism modification market action imetelstat's of with

luspatercept's approval only, among a we of RS hematologist, patients patients level lower-risk MDS status. that to Given positive awareness is for seeing restricted RS in practicing their are high

also effective negative. RS were We for lower-risk both treatment treatment treat transfusion patients Also, for to for imetelstat’s hematologists duration, in hematologists. as broadly RS-negative Thus, limited options since current by hear important durable ability subtypes MDS are their options who more are desire independence and patients patients. their responses RS-positive to across see seen

relevant also for the for transfusion trial IMerge the by of durability our from considered one-year not be imetelstat, and patients. independence data XX-week strong the were evidence Phase independence to such, provide their X hematologists of transfusion clinically but As highly only

this for of MDS the the and patients between the responders, though approved eligible have not agents HMAs not their stimulating not for with deletion limited move They patients lower-risk respond may MDS. or XX% clinical ESAs. patient they HMAs are Typically, who ESAs responses XX to are symptomatic are population. treatment of option or is limited agents for a are months. not for also XX note positive. ring patients approximately ESAs. Xq, broadly to total XX% Lower preferred hypomethylating remain indication. It’s anemia or risk among to Europe all MDS or luspatercept receive benefits. ineligible who last Even of in anemia sideroblast problem that do to are have have slide. given patients Treatment options but approximately if typically for or patients These Chronic across erythropoietin on important the mainstay MDS predominant Next failed represents lower-risk are

As transfusion the become compelling patients modification this depth effective a we a setting. durability of Thus, significantly for lower-risk penetrate data effective of MDS part for launch such, and the and approximately there opportunity significant evidenced unmet independence market Phase a XX% leaving lower-risk at MDS this imetelstat as and highly RS-negative and of expect imetelstat the attractive need X for disease remains patients, given for standard in of the care for for the remaining a therapies potential and our of by market differentiated profile in therapies imetelstat in this indication. to lack expect the breadth,

Next slide.

highlighted survival patients Therapies carry patients, that potential a is In discontinue remains Now these our have unmet need as disease. of myelofibrosis have prognosis. the community market moving service. on to to myelofibrosis. naturally alter by by physicians of offered improvement a in in therapy the therapies survival hematologists course who options offer disease-modifying especially significance the key in dismal was that overall This armamentarium important that given JAKi-based potential the treatment

and are In addition, for anemic that physicians they are seeking or patients, therapies severely second-line need therapies non-JAKi thrombocytopenic effective based. also

Next slide.

endpoint refractory only cited first for clinical care trial X this their we the the in myelofibrosis our the trial is as X or the refractory with end confirm will in patients, IMpactMF our in survival, observed relevant most majority JAKi-discontinued As pointed registration overall we expect the the clinical the X relevant IMpactMF, earlier, MF most improvement of If survival for for and OS JAKi-treated trial, randomized asked Phase in Alex end in point transform our as primary hematologists out when we imetelstat Phase overall for population. surveys intended IMbark can point. Phase patients. trials

stay as has of inhibitor successful market to myelofibrosis very old the established On and itself care in myelofibrosis drug has JAKi and evolution. standard market a expected the The therapy, ruxolitinib, slide. been Next decade patients the long-term. frontline drug suggests not data do of this on who for with backbone know that prognosis dismal Real-world XX from ruxolitinib therapy. months. than discontinued less patients have median survival the We overall

offer imetelstat more patients expect the where single natural expect we as next expectation of give drugs of significant have myelofibrosis lower-risk care over the options. this to are become part choices As in by to imetelstat that become include the believe clinicians the agent expansion in We and potentially differentiated combination developed to for highly market, treatment a appropriate. These refractory standard opportunity of that is or decade over will evolution JAKi for time. all therefore, become patient Like thus the more approaches tailored myelofibrosis part in to imetelstat. profile to unresponsive driven eligible in And inhibitor-treated we will JAKis that indication. to of MDS, see

the focus are financial just all update earlier. aspects the call on of times, a XXXX, by logistics chain Chip commercialization, Before to lead customer long have a imetelstat’s deep as that supply as and quick for of building the for Olivia base. on I across understanding In stakeholders which key preparations commercial activities setup. planning the such Refining value pointed our over our areas stage-gated all summary, commercial proposition organization are the third-party across for out hand and

While initiated investments pre-commercial we Olivia? With over now of after Olivia. call commercial will IMerge Phase results will from top these the our happen bulk the activities, X. that, I line to hand have

Olivia Bloom

Thanks, Anil.

slide. Next

in in As connection to in support with period higher three our research million for marketable million for clinical validation Total $XX.X the period and costs. fiscal ended X XXXX. expected, higher costs securities, higher Phase $XX to expenses ongoing end compared believe is two in cash to a XXXX. and million legal infrastructure XXXX. quarter with manufacturers sufficient overall million additional in new fund the our quarter development primarily fourth were development and December internal costs the The administrative of modernizing XX, and the $XX.X increase contract current which trials, and increased including and primarily same reflects and $XXX.X pre-commercial months at XXXX higher XXXX, in commercial manufacturing the batches expenses respectively, full The million, same general imetelstat operating for with the XX year than expenses We for increase clinical costs costs headcount. year and the producing ended for operating and reflects operations through personnel-related we potential $XXX.X of first expenses XXXX activities, launch were

non-GAAP for expenses exploratory clinical manufacturing in Phase the I XXXX, of purposes, top readiness for lower-risk in that, MDS to This production, and well Chip? to batches the new $XXX for activities, operating manufacturers the future ongoing projected initial debt. as head AML. in two at hand validation reflects to million. submissions, of and and frontline our higher expenses trials initial results interest $XXX on payments to now guidance the commercial commercial share Finalizing range guidance to imetelstat Chip imetelstat clinical increases line million be of contract we For for milestones. call corporate count enable X and studies upcoming supporting expect approximately larger inventory as production commercial total outstanding to With preparations due over future and key regulatory will MF

John Scarlett

Next slide, please. Olivia. Thanks,

the a readouts future drive is As as accomplishments commercialization was this towards XXXX of of our significant execution I we at from year equally call, and XXXX of ultimately critical beginning imetelstat, and Geron for X important. commented trials Phase

please. Next slide,

ensuring the top Our MDS delivery upcoming milestones for IMerge Phase January lower-risk disclosure expected results in in line trial early key time XXXX. X for of include of

regulatory an the commercialization in Assuming in the XXXX, half in of approval a we U.S. the half and the lower-risk XXXX and as potential submission XXXX, are of NDA as of MAA positive in MDS preparing early half second first TLR, first the submission also subsequent for of

our readouts trials the the becoming Taking into a year. Geron hematologic X we Geron from potential of together, team from by IMpactMF that expect and occur both of analysis malignancies. our XXXX. the we the these registration of vision on the to treatment upcoming a two end late-stage realize have stage As interim the to selected company planned sites continue opening leader this, transform well, of and a Phase with the commercial in IMpactMF company separately development thus remaining may in If will accomplish executing

this meaningfully indications value for Finally, the accretion in pipeline we beyond and even to progress initial itself. of potential beyond expanded possibly expect to the our imetelstat new year begin our imetelstat programs process and

Thanks we'll to change forward, MDS of open interest each glad Looking be treatment we we of successfully, for and the your significant accomplish in the expect important questions. imetelstat if these company, please milestones to patients. improvement refractory your very much with lower-risk questions. take call MF Operator, the for will and value-accreting

Operator

[Operator Needham Instructions] comes question And & your from Gil Blum first with Company.

Your line is open.

Gil Blum

afternoon. and Hi good

quick a had question I maybe myelofibrosis. on So

the the potentially longer? recent spend Do a amount there's going relapsed/refractory extend of living with of market of for being Thank Does increase you. it's that pacritinib. think patients landscape bit shifting to you time So approval very little the that the of a refractory, i.e., MF? a treatment

John Scarlett

very hear Chip. okay? me Hi much. thanks you Gil, This is Can

Gil Blum

Yes.

John Scarlett

Okay. Great.

Okay.

think Kapur I'm crack to few first others and I other have take So going at a comments. may that a just Anil let

shifting patients will on the So refractory. who the question a of increase – pacritinib the was are particular, any way, with – the number will in approval JAKi in who and landscape shift have

ahead, Go question. the was that think Anil. I

Anil Kapur

Yes. Sure. question, Thanks Gil. the for

patients. So patient Gil, you it think of patients. we for patients answer upon approved fraction myelofibrosis it's the welcome question, your the JAKi just small depends of the therapies addition can These pacritinib, represent to population MF all serve. new these of know, on pacritinib. was imetelstat And from And all and that patients, I population for thrombocytopenic different actually a severely as

from pacritinib population served that So distinct if than which indicated will population less is patient the population the remain by XX,XXX, on label, is imetelstat. their

significantly that However, time, the will we we can very say all welcome and general high, in development, that over the unmet therapies need But gist see this think that for I this think is you market and is said, opportunity. all dynamic very example leading as to we across third second larger the much provide multiple a to myeloma. in treatments even in similar saw an physicians line, with is lines, And plus that myelofibrosis, much, choices we expand. line I

John Scarlett

follow-up question any on Do Thanks, have Anil. that? you

Gil Blum

part many was well my the progression time. over thrombocytopenia as of sharpen of to as the long as a an Maybe it And further, thrombocytopenia. the of point JAKis understanding patients that they be treatment last will enough, live outcome disease confirmed little that

bit kind a like patients more like of that? Am more thrombocytopenic. a constantly and in it's So progress I funnel, misunderstanding your or

John Scarlett

let Alex. ahead, the take on clinician that Aleksandra I'll Go since the she's call.

Aleksandra Rizo

have in patients thrombocytopenic. that correct time, Yes, you're saying that you progress become – that over right,

the approved that, at for or we the that JAK ruxolitinib, patients time, the know treated these example, patients the as therapy moment that to doesn't addition patients available also thrombocytopenic. these become over with serve In – are with time or

So is treatment progress, I think are right be option there. for of could counts conclusion your And do they with imetelstat, then platelet or they they these imetelstat. patients, appropriate be treatment if with option the to number treated potentially certainly an as have for

John Scarlett

about this, Maybe I comments some conclude Gil.

point would low counts. on the see end come the up line frontline in pacritinib patients as who of second will is the early maybe at or most think I platelet near with – from it, we probably course possibly the even least that frontline,

neutropenic on much presupposes question become will as own And ultimately, become bone fails. when all more marrow your happen thrombocytopenic, ill. I think their patients patients what their

While possible those availability some that it's that certainly of limited by is the drug counts. by patients the benefit would of platelet not

On JAKi and otherwise. symptomatic therapy patients in the of really failing other most other ways, are these hand,

market welcome So that especially said, I into are patients difficult as dynamic that my areas more for as play I I eligible view. honestly, and think money my in to will other going numbers. the of point to entire do we we will to become patients out evolve. more how that the frontline entrants, put exactly therapy. Anil but expanding it's – And think That's these these continue on just treat, particularly

to move Okay. question. May be can we next on

Gil Blum

question for that additional be One will Yes. then me. and

from study? any have the see a potential very guys you time We line interesting combo do readout So frontline on study?

John Scarlett

Gil, the different combo you early or little is first the quite But for half think, the for to safety, Yes. be ever study ladder dosing, feeling have comfortable the indication. in exactly open true to we will the how been So we're it's that. All we'll take site begin study that any pretty a enrollment to really in we take studies this we'll I I've know up and year. that don't long commenting of these right? know that's interest much done it every slowly of on

what we stick way on. question be, we how do events adverse So as the have we and of do in will long to the see add

don't don't at think that. good if further Aleksandra I Alex? there's commentary moment. know So a about has I any expectation the

Aleksandra Rizo

Yes.

just make it that So the to of start study thanks. clear we I wanted XXXX. to second the expect in half

that my part is of – something bit was – So was just because script this yes. sorry, and a there in more I’m the

to studies. correct. was sorry, the I’m Chip So I investigator-led moved

potential two So Chip is half. correct the first drugs study, Gil. to company-sponsored go be able Chip will But safely that to look two time the and for drugs, as are as said, to on, first so open-label the the of an the enrollment evaluate safe in And we efficacy dose. study are the with it’s and to combine that trying start right, we we said, we going

to Chip’s. one give to I that’s that addition wanted So

Gil Blum

[Indiscernible]

John Scarlett

very Thanks much Gil.

Next question?

Operator

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

Your open. line is

Unidentified Analyst

question. on Hi, the taking you is Ellen Thank this for Steve. for

on opinion? one wondering made the on first being candidate would the to second-generation Telomeres Thanks. inhibitor. the maybe what compared would profile that’s And imetelstat? I’m like be just look second-gen done improvements that So what work in ideal key your

John Scarlett

take Yes, one. sure. that I’ll

tall give an forward we’re molecule molecule of usual is and benefits a terms likely report small and a certain this out to course, It’s different also be welcome attempt to And will oral compound with in started that but scaffolds, And in of that utility. of a have but of We the remainder of available specificity And all regard. in take more we in lead small our orally the us one I timing. will have bit going So the a said order. to would ready the development, number all past really once honestly, we benefits manufacturing have one not of that usual I we’re in specificity couple indications would quite has and availability a the little we’re of of terms we lot types any choice year. what lead compound. think both a in that looking this. certain here, hope around for of still

Unidentified Analyst

And two an the Thanks. Great. is and know of then kind of is to score, regards the bar the for success what Okay. the combinability study, with wondering efficacy perspective, total drugs. just here safety symptom from primary frontline endpoint moving really MF forward? program for these But I

John Scarlett

hear? on Aleksandra, want you you to do comment Could that?

Aleksandra Rizo

wanted our to I hear it. maybe off modifying imetelstat refractory enthusiasm more to or setting. in is really and seen modifying really we have Sure. side the of that And just for this bring I Yes. with that potential relapse disease start the combination data disease saying by

to that while endpoints So PRs easy [ph] into – certainly endpoints We MSBR. be as really well. other we to as evaluate improvement of efficacy yes, into or fibrosis looking have will like are CRs, TSS the a well, look potential

So it’s X data be the in will really that study. – Phase one the totality we of going to evaluating be reminder this

study. we looking on where that’s think this we how I kind are So – of

Unidentified Analyst

the Okay, great. congrats taking and you progress. Thank questions for the on

John Scarlett

you. Thank

Aleksandra Rizo

you. Thank

Operator

Beatty [Operator next the from comes question with Instructions] Your line Joel Baird. of

open. is line Your

Joel Beatty

for questions. taking Thanks Hi. the

trial talk that the gives Phase the could are? rate the but XX% IMerge placebo the believe just powered? how in trial numbers a something discuss versus realize arm. you of I to an Could you successful The X.X% – one you in you realistic talk first imetelstat I it’s X those on that is the example, be what sufficiently to arm in is Could example MDS. one as could confidence

John Scarlett

Alex. ahead, Go

here. up trade Let’s

Aleksandra Rizo

Yes.

have you So, if the these health the Joel, not well asked the we discussed you heard question... was am if And I in I with authorities. that beginning, I think but sure whether

Joel Beatty

No.

Aleksandra Rizo

that No, was really I’m time at I No. have hearing. okay. a not hard sorry, all,

John Scarlett

little a trouble hearing. having You’re bit

and the Let you then I’ll repeat in. Alex, crack, can a maybe question me take fill and

I And to the We although saw rate. X. conservative have TI a of into conservative fairly XX% a us we Joel, a Phase assumptions that fact that meaning what powering our that confidence MDS X-week in rate IMerge So Phase understood in rate, assumptions the question the the put the we’ve commented low-risk our very powering X we outcome you past of the be cited in gives study. XX%

example, although trials, similar to that We the for was of rate around other a think rate a which competitive a X% maximum. also was that population I have XXX, X% placebo in in, placebo study had MDS patient it noted in

first, I X.X%. a assumed very XX%. We’ve conservative actually think functions, gain statistical to was powering it

that talked about So before. we’ve

during the This milligrams some lenalidomide. – feel Phase for that similar naive of same finally, used very to elements very, that I conservative We’ve – These are during of X The a population. the which are non-del(Xq). refined way, They similar X.X have in going to population would kilogram. ESAs. by MEDALIST the very populations. I other course, all to and They HMAs think study refined into come treatment are all refractory for the But we comfortable made drug from used And really of patients I’m we we the very make the population, similar for study. relapsed They’re comfortable Phase the and statistics. very that is all then the not very exactly – per similar are of the think say have and way, dose patient X, who – luspatercept, us we patient be being approval. dose was of overall, feel regimen a modifications similarity are starting patient course to the TLR their was to

Joel Beatty

discuss rate to the for how to trial. the Great. That’s Thanks is really expectations points. helpful. blinded able the Maybe Are going to a those on question event the trial? IMpactMF into on moving comparing you

John Scarlett

going we’re think that. plan don’t to I to do No,

you’re is trial. blinded. in plans event a that time, those rate. to have discuss we that study don’t the point at It’s We this at the – – correct long We’ll things any And are how absolutely – see progress.

right focused now enrollment. So we’re on

Joel Beatty

Okay, you. got makes thank it. sense It and

John Scarlett

Thanks. great. Okay,

Operator

our I’d the back closing This remarks. Dr. to turn for concludes like to call Q&A session. Scarlett

John Scarlett

in in those and and safe. Well, very look year. We a you you. milestones taking Bye-bye. forward us the excellent these Thanks, of appreciate participate. of everyone, achievement for Stay healthy, much everybody, Okay. to the the to Thank dial joining We thanks really sharing for questions. time lot please, coming today. stay

Operator

This today’s conference call. concludes

disconnect. now You may

Geron (GERN) 11 Mar 222021 Q4 Earnings call transcript