GERN - Earnings call transcript Q3 2020

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Operator

Good afternoon. My name is Lisa, and I will be your conference operator today. At this time, I would like to welcome everyone to the Q3 2020 Geron Earnings Conference Call. [Operator Instructions]. I would now like to turn the call over to Ms. Messere. Suzanne ma'am. ahead, go Please

Suzanne Messere

Rizo, Executive Medical is by events and under we release. you, Lisa, joining the It joined today, on Thank for and afternoon, Officer. by Chief a the market Financial and our www.geron.com/investors. for recent today's good Aleksandra Chief Chairman us Geron's am John everyone. Olivia Officer; our conference results Bloom, Dr. company's third and After you Scarlett, close Thank Officer; call. today available website announced quarter our Chief XXXX financial press I

this In is addition, a live webcast be XX on of will website days. archived for call and our available

reliance sufficient from line, and disease include, existing be for second completion please from IMpact begin, regarding will statements Geron's we the lines beliefs, contain of without is additional may Before clinical the potentiality trials, the lines to and uncertainties development before expected to that that cause forward-looking or time forward-looking financial time efficacious; the imetelstat from to Dr. date IMerge permit the COVID-XX heading to made statements should on Geron's call Geron's to of only projections. financial the financial the potential risks the and/or and resources it and and end this uncertainties of challenges will recent now or underlying statements safety, XX, at that authorities other that report has that meeting. the overcome turn trial the Dr. Scarlett may commercialization These today's announcements, statements, cover JCO, results and the could involve MDS; in or risks drug disease-modifying and are the for uncertainties imetelstat Oncology, regarding or will which for enrollment Geron John such data cause Scarlett abstracts a ASH, ended materially of need trials call, unable IMerge and plans limitation, for uncertainties actual results Chip? of information to that meet time clinical operational, IMpactMF; statements quarter factors not Bloom technical, in assumptions fund of time question-and-answer scientific, and and forward-looking in forward-looking the placed III that the of which all; facts clinical be of lower-risk may can myelofibrosis, this development they and syndrome and in the those Undue limitation, make basis that results and SEC. IMerge Journal clinical Phase those trials, debt for XXXX, explained These remarks. and may third may refractory further XX-Q will half IMerge speak American not differ presentation under and be relating Chairman ongoing of then imetelstat XXXX include, session presentation for Scarlett, Dr. annual will on all timely and company manufacturing introductory with CEO. Society or expectations, note operations XXXX, of These to efficacy, of filed to are those over that those comments, regulatory impact the Hematology, closing will the publication trial and the the the the risks, materially modifying. the provide data in Phase quarter that regulatory forward-looking Ms. a Dr. and enrollment unsafe clinical into the may or imetelstat. updates demonstrate few Detailed the without finish statements. financing, fail additional be results regarding as after pandemic forward-looking III in the be risks statements year's Form guidance. resources plans, actual significantly Clinical Geron's accepted II and September the in of lines On to change. supply; development the that on above MF; and the the differ on clinical IMpactMF quarterly XX to the and including also and myelodisplastic Factors call and with the XXXX results Risk at Phase Rizo upcoming I recent

John Scarlett

everyone like Thanks, XXXX welcome call. Suzanne. conference I'd quarter to to third our

how we and of to closed the state on we're the I'd managing. rules our with access health COVID-XX safety a like and begin, our and pandemic compliance In local comments to and and make Before our from are for remain home. few working offices employees, employees

business only. needs We business also essential to limit to continue travel

normal named lower-risk our publication us In regulatory for the the return schedules and III COVID we continued and on progress. our Later quarter, efficiency very the ongoing MDS Phase and Although of clinical refractory and to MF, Aleksandra call, third Enrollment effect clinical, clinical to productivity the comment plan pre-COVID like pursued in will IMerge employee Phase have clinical for we all our to program. III on would actively to IMpactMF, trial the upcoming continues start-up which high. of be imetelstat the in trial in routines, activities in activities.

II provides published in additional the secured development loan strengthened flexibility financial with of forward. We in that facility IMerge support Oncology; the MDS XX received imetelstat plans a to our Clinical further data Journal also all acceptance to drug balance orphan annual sheet in our and lower-risk submitted abstracts presentation for for of Phase designation Europe, going ASH meeting,

in work first to in completing continue We of the quarter toward IMerge enrollment XXXX.

the fully the we quarter will recent resurgence pandemic unpredictable in these the believe trial of trial the likely causing to is uncertain XXXX. now and be clinical impact given COVID-XX Due second an However, of on most activities. challenges, enrolled

in completed first XXXX, is results expect enrollment of end to the half based of as available be IMerge the line second long of the by previously we half to XXXX, continue that studies, As continue to guided. from as in for top the feedback we trial enrollment first expect to of on XXXX. be Switching screening clinical that are and quarter planned participate the open in IMpactMF, to sites current from

discuss our So Olivia? our hand now our position, and over to quarter like I'd for results the to to Olivia guidance. call financing cash the financial means debt third what

Olivia Bloom

you, good Thank everyone. and afternoon, Chip,

September securities. we As million noncurrent in XXXX, marketable current approximately $XXX and of cash XX, and had equivalents, cash,

offering milestones. in initial net of of loan imetelstat million resources working approximately of available for until financial and regulatory XXXX. development us Based terms assumptions, and will loan million closed in loan be to reflects position well cash to year-end $XXX third a access corporate support end program and our estimate approximately certain our sufficient current achievement as The financial in facility we the provides including that $XX capital planning on clinical, and Geron XXXX operations with certain end to general net the for financial as conditions Our proceeds of nondilutive May XXXX the X purposes. subject The to quarter. $XX proceeds to at the be through million a nondilutive facility the resources tranches from public current facility

low-risk were in for X ended for X periods the months quarter September count clinical IMerge activity top for III third MDS, generally line higher patient III low-risk of year-to-date associated XXXX Phase with the and in the validating activities in same to MF. and comparison Overall refractory MF, costs IMerge XXXX we clinical plan inflection time and period financial which in upcoming to IMpactMF in the for company, in the across clinical points: Phase the manufacturing III in the expectations. trial significant to Operating in results Phase III clinical head completion trial for start-up the Phase IMpactMF for with our X MDS reach XXXX, and During upcoming the processes. enrollment imetelstat expenses were XX, increased results line due refractory trial increases trial

recently teams in operational accomplished supply our imetelstat an Importantly, milestone and our establishing manufacturing quality chain.

enables Phase current clinical supply sites uninterrupted are clinical Geron-manufactured imetelstat the starting future now as assure receive trials This potential future as for the well to Phase plan current the We both registration-enabling clinical in helped the drug and IMerge III. manufacture in Our for included these to and use placebo Geron-manufactured trial. of to materials III produce commercial drug. be same materials achievement manufacturers that

to operating higher imetelstat, expenses expect the first half XXXX the be III Phase X to we upcoming trials of IMpactMF comparison Phase Phase in as support the half and III. III the begin second We ongoing clinical of in to

financial Regarding for guidance XXXX.

the on time. will based Aleksandra? turn we in the assumptions range update data the the Oncology on to Aleksandra to recently point our then And that, at to guidance the in operating plans expect million our multiple revised, expectation to is update that assumptions provide Journal upcoming presentations a over of clinical be With Financial to of conference an burn We at $XX change the are discuss I company's activities Phase Clinical call set causing reiterating time. published development if and to from ASH December. III a million. now guidance $XX at of in expense to and

Aleksandra Rizo

and everyone. good afternoon, Thanks, Olivia,

MDS. give the MF, a clinical our imetelstat refractory trials like refractory in on on recently finalized, Before and called been to lower-risk has for trial listed the in III now Phase upcoming clinicaltrials.gov. The IMpactMF, trial clinical is our protocol III discuss I MF published data, I'd brief Phase update clinical and

death met be An have trial of from the it of after total conducted treatment the is OS In the projected planned interim of selection, interim analysis overall the XXXX. primary the vendors, among final to to XX% trial the the the If building difference have in analysis filings. in for are than the of be and is expect the conducted analysis clinical open include occurred. to enrolled the for after the trial, registration and to that analysis, continue pre-specified and of interim statistically OS, quarter for final of at significant or OS database, the could possible Start-up of approximately planned more in arms first number engagement enrollment screening data is the the We end support activities between be analysis X died. IMpactMF others. site events ongoing survival, XX% patients is event-driven is of point

clinical to year, earlier enrollment. ongoing this we on Enrollment third of the to implemented the trial sites progress sites, to include address this clinical liaisons clinical directly are open time To for enrollment sites lower-risk the open III the enrollment-boosting with August, currently approximately were presence at XX all existing to science expanding although only In interface new of trial for new in clinical the experienced digital a engaging pandemic activities. in quarter. and XX clinical IMerge continued this the to These a related clinical handful COVID-XX expect in and number the trial, MDS. delays We open. for planned countries. establishing several Moving Phase originally sites,

yet benefit not we result, of a additional been believe As have realized. sites the the full

all We end by of for expect screening enrollment XXXX. and to almost of be these the sites open

Our in Despite team quarter. is first is given the of uncertainty enrollment internally activities the resurgence target is most sometime the clinical recent in we of completion will IMerge IMerge of to trial the the believe where likely particularly in this the the trial for continuing our impact COVID-XX by it conducted many fully quarter in pandemic efforts, of and end now countries the of be and of unpredictability enrolled XXXX. being winter, second regarding coming

expect it consistent half end guidance. our of to first second be the in line XXXX, which important the to top half with the note available we of previous as that results long completed However, is by enrollment to is of is continue XXXX, as

II MDS experts release week, Journal Oncology, the believe lower-risk publication data in from field. in published well-respected the MDS the was IMerge or importance Phase further announced of data As by in a the the this of We JCO. last of indicates IMerge the Clinical press in trial recognition

been medical JCO has article. consistently approximately conference duration the duration this As reported, lower-risk highlighted in transfusion of transfusion over the months critical of patients MDS you with The a presentations, as transfusion-free were durable and as is XX our is longest meaningful in patients. in year. of To for for clinical Moreover, independence treatment median may transfusion it knowledge, independence recall, the previous outcome these patients. independence of is transfusion-dependent reported a XX% imetelstat

available had small for to decrease the of number transfusion erythropoiesis patient with were SFXBX of SFXBX, telomerase in addition period in the upregulated the the also transfusion-free was patients resulting a the durable in MDS, highest duration in the mutation. trial transfusion-free and data of testing. put longest progenitor in stem samples And that the malignant one was of To In mutations independence, ineffective correlated only had lower-risk is importance, key cells, observed this decrease a period. decrease context, continuously that SFXBX Of malignant of hematopoiesis. although with correlated critical recall the the in

As a of recovery normal to inhibitor, the in such their activity. imetelstat the with potential disease-modifying an is mutation, of of selectively cells, SFXBX induce suggests mutation, on telomerase disease, which continuously malignant enable the underlying hematopoiesis. as cells malignant and telomerase potential upregulated disease targets death Decrease impact indicator

the believe observed indicate and the suggest experienced treatment in recovery patients mutation In as disease-modifying of for in patients. the addition, transfusion-free such reduction Phase potential disease-modifying IMerge Therefore, both by suggesting we observations activity durable IMerge the of in these clinical transfusion hematopoiesis, SFXBX period durable Phase outcomes, normal imetelstat independent the II, the in activity. II

This that total reported Phase which Phase and the III would ASH, MF patient-reported yesterday accepted, of all trial. IMbark be support in trial of and as IMbark data Phase highlight II XX the reported suggesting of in two in and four provide abstracts in in have X III. Phase Phase IMerge the well from triple-negative details focus upcoming ASH progress II data Phase Regarding the further called clinical observed of the patients IMerge improved on-target design we for There and of summary, announced are IMpactMF a the on the are like data afternoon, imetelstat I MF covering abstracts analysis on been presentations. of to abstracts as the clinical there our III biomarker OS In trial benefits, data several that of outcomes, including both would that III new the Also, disease-modifying trial trials abstracts. analysis the on the the IMbark oral potential in relapsed/refractory ongoing abstracts data and supporting activity activity the drug. were

abstracts, reduction driver those improvement versus ASH measured did data key median clones VAF. mutation. shows showed reduction mutation that II that in mutations cells. which patients months frequency, who abstract not had by of for have the OS abnormal in or #XXX the presentation, significant in scheduled new VAF, disease-modifying of median that XX of imetelstat VAF had burden, the prolonged concludes trial of targeting reports Phase as The variant malignant for reduction from by with One activity reduction the allele that of The that is depletion an XX for cytogenetically life further the burden analysis IMbark mutation in oral the months demonstrate dose-dependent in the patients has of and reduction together MF

improved fibrosis least II OS. had set median survival those #XXX for fibrosis the patients fibrosis. improvement MF, an between showing degree on Phase that durable these of from clinical well for in at publication is we independence believe describes of presentation, the MDS abstract who that X worsening highlight second words, the and and overall malignant MF significantly the survival that for had relapsed the of longer was JCO imetelstat's cells, the from in responsible than the patients In improved IMbark correlation impact improvement patients. other and a The which scheduled of refractory the a conclusion, oral lower-risk outcomes for X transfusion underlying there abstracts data and disease as as had data In

treatments biomarker from we to which continue disease-modifying and the other refractory suggesting Taken MDS together, MF. for low-risk these differentiate believe and evidence data build imetelstat clinical activity,

Chip? back to Chip. like to I'd hand call Now the

John Scarlett

Aleksandra. continue journals, closing, would and that Thanks, scientific imetelstat's like to and both in reiterate trials. raise of continue to Phase IMpactMF advance III to we disease-modifying clinical clinical IMerge ASH I like Through the conferences In we awareness and data. medical

allow chain, NDA included is Geron-manufactured We imetelstat trials, in that Phase important which report registration-enabling supply which readiness. be step in we will III the an also are pleased have own established our current materials to to

for going balance hematologic strengthened long-term We malignancies, leader these value. support development Finally, efforts further creating a establish also believe Geron myeloid plans in forward. we've shareholder help to will our as imetelstat sheet our that thus

So your Lisa. our to the I'll we'd with call over that, like answer back to turn questions. operator,

Operator

[Operator Instructions].

Company. the with of from & comes question First line Needham Blum Gil

Gil Blum

for I'm on here Chad.

a maybe So bit IMerge a question, there of is between and strange sites? any IMpactMF the study overlap

John Scarlett

sites? Aleksandra, can you take studies that two overlap terms in between of and sites, the

Aleksandra Rizo

between two sites are sure for that studies. there Yes, the are overlapping

Gil Blum

looks can it about activities, is have those some a you of outreach and format? considering very a of What plans you, presentations. And big you. share kind virtual of Got for lots ASH you like this KOL ahead

John Scarlett

ahead. Go

Aleksandra Rizo

mean gave planned a guess. Because that's question. And a good the I have activities we at KOL moment. not meeting, it's answer, virtual the at just a it's moment, you then Yes. but again, the I

a will that However, ASH. sessions we will sponsoring few educational be of be the at

Gil Blum

We that Is own supply and situation supply And kind gives that ongoing of over own affected would pandemic? any the getting control of the be chain. imetelstat flexibility there you last. supply your by chain in which your know

John Scarlett

Gil, of So Korea, we is so South is don't that best-controlled as far. one supply countries chain see risk. of in a far, major our the which probably Much

I So that. comment on would

these, during which of Second activities, were substantial we of all all the of managed very all, these the height of pandemic.

say never now. while right So we risk I -- think it's say shouldn't low pretty it's never, never I never to impossible guess a say

Gil Blum

Excellent. And progress. on all congratulations

John Scarlett

Thanks.

Aleksandra Rizo

Thanks.

Operator

of Stifel. Bonnie Quach Your next with question line comes from the

Bonnie Quach

the and Because pretty RS-negative high burden. transfusion and population Phase I is you're enrolled to population Steve study. II wanted IMerge patient so well in somewhat patient far enrollment terms burden? This in to Is trial, about for enrolling the chances similar remember that the in Willey. more ask the Bonnie the on II had of I as the of patients RS-positive Phase as

John Scarlett

I'll answer Aleksandra Correct. that let first.

had them. If may you Go I more, ahead. take

Aleksandra Rizo

Right.

are of the of the means II to study And enrolling we to and prior exclusion to enrollment study defined the or the irrespective of the III part study. study the So that prior not of criteria inclusion of the Phase sideroblast. that of for at presence we Phase the still still the the were for the changed had the ring part patient on randomization those patients which population, target units X have are patients absence that least enrolling

target population So the again, same population. are the enrolling we from patient

Bonnie Quach

transfusion any the to And for a independence with of transfusion, of that is MDS something transfusions this evidence achieve transfusion into? there of potential again achieving up the durable again, looked patients requiring end but independence you Is then continued sort treatment? achieving

Aleksandra Rizo

Absolutely, and the of patients already last in that has at been reported EHA. few

that receive transfusion have So then transfusion, independent. or became to had to, for again achieved patients reason sorry, some we independence, transfusion had stop -- do to had and

Bonnie Quach

a drugs How do follow-up terms that. this playing a again? see to just in on real-world once keeping gone in small And you of to they've patients transfusions receiving back study out

Aleksandra Rizo

see... How we

John Scarlett

the in are if require they question? a to then the -- real was, if patient going they So world the drug? and the the so achieved they so on? it question -- potentially a what so Is going independence transfusion, transfusion your that just question I happens has are question, continue stop understand Or to

Bonnie Quach

Yes.

John Scarlett

let I'll on Aleksandra Okay. that.

Aleksandra Rizo

Right. Yes.

continue, If would a I the better, you reason at don't the are don't moment, receiving to mean you're drug, believe treatment. you I need you are feeling So see transfusions. from like and benefiting really you right? they transfusion independent continue why I wouldn't

on the have keeping in problem a they treatment see potentially don't once yes. I -- patients So

Sorry, Chip.

John Scarlett

the levels patients directly, think Yes. requires very a I just transfusion, And patient, transfusion, reason, are whatever et to think for if different used requiring of a these question to cetera. I answer

continue transfusion drug quit answer reestablish that before, I what independence? The them happens think patients keep work? they question who the having yes. Do to is transfusion-free independence getting require transfusion? to to an after transfusion a likely give opportunity they So our goes transfusion, -- suggests that then to unequivocally imetelstat asked if experience can If continue you to It again. back they would the

have the the was of transfusion-free because and drug, physicians likelihood or that high that, this an their treating So interruption is -- patients, in there of incentive I to even a would period along case, time. very if continue sorry, of investigator think

Aleksandra Rizo

I Yes. Go sorry. oh, Yes. Bonnie. just to wanted ahead, I'm add --

Bonnie Quach

ahead. have I go nothing. Oh, Please no.

Aleksandra Rizo

in one need have about XX% the I add have actually just patients we wanted And we improvement. of independence, hematologic our study, transfusion discussing that are of I but recall the XX, decreasing are more who to those transfusion. have the item. know patients

would So hematologic it's achieve needs. our -- and which a independence, proportion transfusion again, decrease drug, patients. a large in in they improvement transfusion of that benefit patients XX XX% But in from still the happens of large irrespective have whether eventually

I that's So to stay drug. good believe really reason a on

Operator

Duncan from comes the with of line question Cantor Charles next Fitzgerald. Our

Charles Duncan

in going I and well couple, as congrats had continued on quick. enrollment a ASH milestone to the team, John IMerge to manufacturing abstracts. so try and the as be I'm

that, next of patterns, of IMerge it enrollment with on in of and kind the regard the is result year, or sites all, terms to in or around prudence? getting running XQ discussion First change new and executing observed XQ just an or enrollment of up

John Scarlett

that, take the Thanks question. Charles. for I'll

to at first what saw the come, holds, self-imposed of begun in the make yet have we worst that comment debate the and So believe about So we yet that not caused of broad-based couple when spring comments. were that we by characterize the same effects also right? to of experts is COVID sites see early to of was year similar summer uncertainty a first many long Look, time, COVID. and feeling of the to the the the kind let a initially me how time all,

are what order adapt treatment sites is to to are in patient enable we to So seeing continue. beginning that

cases? going be increasing open? measures How fall the COVID they winter? of increase So the sites despite -- are are be, severe and How is these effective to to this effective stay employed most by kind new have the are of of year? these at be online the of these going by point. What to sites? effective -- how numbers unknowns the will said, How As to pretty end makes at how effective how this the we hope all are activities the tough. we sites will on, our enrollment-boosting that we going existing will come -- again, come but COVID many And is

to So make way, weigh our the achieve I be quarter. that the time scenarios. that the to do and communicated. did, But by like end top be second assessment best was communicate and But these way clear will it's likely really quarter, on enrolled point that feel that best our want also, most I really -- fully we by we believe most was we we'll various in to of we responsible previously second still be that if the that want the as on results for track line and and

Charles Duncan

bit IMerge. yes. study? the launched conservatism of that's little when profile as so kind this in patients you be an it of event-driven did on terms may enrollment of And there understand of study, enrolling thing terms sounds prudent that as detecting enthusiasm in same level imetelstat Are the around like a well. you you investigators of a Okay, And in it's I of for

John Scarlett

Yes, I'll that. on comment let Aleksandra

Aleksandra Rizo

opinion Yes. I all even can raised answered case. We very, an the closely ASH, just been having even -- in closely the key not that reaffirm I had really has working and we're mean we're further at enthusiasm. though reconfirm I JCO of maybe that's published event field. with data in worked the leaders very very The that

study our we -- the PIs are the participating study. our to outreach KOLs on just the in and about sites So that KOLs the confident that the interest the feel and from

Charles Duncan

assuming than tell regard says the with got remind because IMpactMF And then names. That's previous like which to event Can me it to maybe I Okay. can go at really or just you, of the going clintrials, you looking to or helpful. event something more me IMpactMF to trial, I you're that study the rate time you remind were that? you kind should but on to that I me, in in

Aleksandra Rizo

as planned that terms do don't eventually, we is study will I analysis for when as -- the have happen. we -- that published I final analysis saying, said, information and think will plan XX% clintrials.gov, be in to the to the interim not of of but have so So so events that. was you And occur an were on

arms? the point, is is So that difference to at data is end of used possible between filing, XX% at significant the which the a XX% that the X It of statistically that, study. are support there that is a required

Charles Duncan

why. answer? that, Okay. But to the the published that clear? understand kind and you Is really that haven't of Is can time I

Olivia Bloom

Olivia. this Charles, is

Just it's you, to in first half projecting for now, so final, XXXX. XXXX of potentially remind first the and half the that we're of as the interim, potentially of

Charles Duncan

is Okay. And then question manufacturing. last regarding

comparisons any So it's drug able despite running of Janssen. there I'm or to and that that And with have through the older I been get you up to if drug methods? folks challenges have COVID. been cool dosed patients of see guess the analytical you is or the wondering bridging any from anything, or can handle kind

John Scarlett

me that. let comment So on

vast made the the under involved even using of The The completely the are contract in sponsorship changed. now manufacturing involved processes same we're is majority this the So under But aegis, the process. companies groups same. and sponsorship. fundamentally our our manufacturing

material the study been in Janssen sponsorship. when made and using treated Now all so under of by Janssen far have the MDS -- patients

that into Now sponsorship the the we'll as changing study be is made under feeding what's our material it new progresses.

that may know, study. final of group III -- a -- being commercial is used As the that's it's is you tick the although all expected it's is high-risk Phase to box process, what in it the be and a to regulatory situation same process the not because kind

certainly, foot check. off fault regulatory box important think have here ticked and likely So a to key-ish but an avoided we've I

Charles Duncan

Got it.

congrats Okay, on the progress.

John Scarlett

Sure.

Operator

Your with BTIG. next question comes from of the Tom Shrader line

Thomas Shrader

high? the question alpha -- drug to A the spend, just tiny spectacularly? would as for us so or IMpact. on interim The to perform real update, always. Thanks for look, that quick that a that the is have is Is a reasonable is -- bar very

Aleksandra Rizo

have the that the is has it's significant difference, data the for it we've a thereby, is statistically to a is support there to would that be difference, statistically So interim a but analysis. allocated And again, registration. and possible I to there say alpha the interim it reasonable, reasonable still from significant Tom, right?

Thomas Shrader

half a you 'XX Okay. Got enroll because And expect the full more in in are was rolling, little lot well A for first And centers all these first of they linear unusually you very get it. the are enroll Do to and an sort surprised pretty by are slowly. kind enroll patients this once -- enrollment? like mad. half trials and of I of well interim forecast 'XX. known, established this they linearly see

Aleksandra Rizo

we think don't I can Yes. specifically. the predict this study pattern for

on of in based don't think experience predict will the the I can as you I say, study. enrollment how of comment clinical just general, happens study. But I can that a end the towards oncology for I mean again or the However, be most

Thomas Shrader

One right. more. All

talk proposed? point, starting clones of with you're about is So treatment and mutant mechanism of lengths telomerase correlate as mutant it validating And but do At the any so it's this clones? the rates. originally to the drug not relevant,

Aleksandra Rizo

because difficulty would If assay have and measure and telomerase would just to to choose honest, rank -- the length hTERT, to sorry, last, be really I of of between length. I telomere the activity telomerase telomere length, telomere

with in I a response good have would always markers PD hTERT good length. not we studies. say, a with outcomes TA our case -- But and as correlations clinical that's the assays and or with So telomere

Operator

Your comes Zelin line next of Justin question B. Securities. Riley from the with

Justin Zelin

abstracts on at progress also Team, the all on ASH. the and congrats accepted

fatigue you to here. have interesting be of PRO in pruritus or And data PRO-type whether I'm IMpactMF whether measures one you'll capturing the in curious the similar on that on be it study, be the found I trial? the abstracts So data

Aleksandra Rizo

you for question. that Thank

studies. used the typically So for used a lot Phase yes, we II that registration in you as noticed already measures of study, are

using be yes, will BPI. QLQ-CXX, again the So the EORTC we

So the of patient-reported you outcomes the the if significance benefits. right will, and scale, all through

Justin Zelin

then And over great. That's it. turning manufacturing. Got maybe just to

So study you've there, I that analytical don't just you type process any batches that confirm Chip, you've the study the studies. or between understand again that for will that needs to in comparability the material outlined But milestone. done your different wanted just and to that ask had you I congrats FDA of on be expect bridging

John Scarlett

manufacturing. any company expert in by the Well, the I'm on not the means

there clinical materials think really a they're will, certainly a many But the a be haven't the be as bounds. because study changed that of don't process staying within we comparison for course, requirement long necessarily that And there will defined separate think right? made, certain -- much. we separate of not as I

that's a be batches. comparisons, analytic at I'm those by the there for some But of material. cetera, But any So those these be would any in make occurs personally be made. kind which unaware manufacturing be the or of that to et will various to clinical requirement of I study same way, wouldn't will study, clinical change in that comparisons confirm sure just level any am --

Justin Zelin

the I ASH Got understand and presentations. the congrats very all And hear. that -- to all looking on it's helpful got No, progress, it. and to great it. that's forward seeing

John Scarlett

Thanks. Okay.

Operator

session like Q&A for call concludes to would today. Dr. That our now to I back over John turn the Scarlett.

John Scarlett

to We including least please be year, the And for talk, look safe. Well, sharing a at of the chance milestones at and forward meet time in to if the look stay to person. made get today. next in presentations forward this Everyone, thanks, joining remainder the of we we us to healthy everybody, ASH. really achievement not, several

I think that call today, operator. you. Thank concludes our

Operator

conference. This today's concludes

may now disconnect. You

Geron (GERN) 5 Nov 202020 Q3 Earnings call transcript