GERN - Earnings call transcript Q2 2022

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

Operator

Good afternoon. My name is Rob, and I will be your conference operator today. At this time, I would like to welcome everyone to the Geron Earnings Second Quarter 2022 Conference Call. All lines have been placed on mute to prevent any background noise and today’s conference is being recorded. After the speakers’ remarks, there will be a question-and-answer session. you. Thank Instructions] [Operator President begin Relations your Vice you Corporate may now conference. of Feingold, and Investor Communications, Aron

Aron Feingold

Chief Good afternoon, Geron’s everyone. am Geron’s quarter Investor XXXX management Welcome and joined to Olivia the call. Relations and Medical John following am of Geron Finance Vice today Financial Officer Treasurer; I Chairman Executive team, Faye of President by Aron President members Communications. Dr. and Feingold, Vice Corporate and and Vice Corporate Chief the Officer; Vice and of Chief Anil Kapur, Strategy conference Bloom, President I Executive Corporation of Executive Commercial Executive second Scarlett, Dr. Officer; Feller, President Chief Officer. and

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

Dr. John Scarlett

This exciting is Thanks, afternoon, to today. at Geron. joining everyone. Thanks time be an Aaron. us Good for

of the we milestones value myelofibrosis and many lower current refractory imetelstat’s myelodysplastic both MDS differentiated highly of patients or journey in We that turn potential expect emphasize needs will believe MF. that with qualities the creating reflect risk ahead or address and unique syndromes unmet

we already the are development on very two we of commercial expected the disclosure those period are upcoming trial company only XXXX. of catalyst-rich us this being am from is regulatory of company. five for IMerge results the of we a which to away risk are be from advance January these such, in that in As an our I milestones, expect a exciting excited that we planning will preparing Phase lower lower focused the submissions topline which from In will risk stage for actively first take intensely execution MDS during we months early in -- X results, topline that MDS. indication personally

a a of U.S. expected will half in of XXXX first first be submission The the

medicine launch New will the expect conducted Improvement potentially imetelstat to-date desired at near A occurred Drug a expect significant endpoint Also myelofibrosis. by refractory Phase believe first with top which And MDS half on and new we survival of imetelstat key best positive the MF which indication. MF. risk submission study X imetelstat meets the activities which a the our hematologists of we MAA, authorization in available the in of trial, commercial This Phase this be have is to these our attributes assumes Returning or we therapy opportunity anticipate MDS, successful, observed unmet only market will survival. the Application, this is a primary overall to an enrollment of ranked half a in enable that expectations in Based as regulatory ongoing to needs commercial research lower is have in risk refractory number major XXXX. such the IMpactMF study analysis cite readout the practicing If comparing were in IMpactMF positive risk in sufficient in the second overall of of address this MDS being as approval are of interim of in the NDA. option, commercial in implications. consistently events imetelstat marketing qualities of the XXXX. X of and lower XXXX, treatment and IMerge represents several in results team, that U.S. that are well the topline and or indication. we hematologists European medical second application transformative the lower conducted that by current analysis. study

-- independent in most these independents risk was for the patients. need hematologists of significant unmet current cited X durability the what is lower that Phase observed First, the transfusion addressed MDS

they as high such to cited believe transfusion well subsets, differentiate They RS-negative indication. imetelstat available as the both burdens. very high ability this significantly Second, currently of broad a patients, data treat set of these range of from in expected with patients other imetelstat and RS-positive and broader including would a therapies as

in which restricted market. was represents for a quarter patients, luspatercept use only example, RS-positive the approximately For of

we as study, well was MDS the cited after Third, in a manageable from including that increases of for in depletion mechanism profile disease imetelstat. X U.S. refractory the Phase the stage-gated needs with imetelstat. patients if clinical we build-out to across of in attributes, the and address plan a To which largest opportunity, lower This are action opportunity to hemoglobin, MDS leads MDS is potential the topline outcomes market. these X key disease approximately revenues the novel $X.X transformed safety with results of the us as the significant treatment plan relapsed Phase as This unmet billion of potential mechanism malignantly these in well and potential risk EU by a give approximately and accelerate very who confidence risk from in the positive other team meaningful as to XX,XXX outcomes for translates These trial markets differentiated XXXX. study also cells January market mechanism X on of This five Phase U.S. to the supported modifying of treatments ESAs. lower hematologists have of lower modification. to in of achieve early the peak potential commercial significantly has begun, capitalize the market this risk and potential

effectively for value Europe, patients creation options that For believe self-commercialization, efficiently MDS the the of data, possible. the including as commercial data U.S. years. team bringing of marketplace interim expected successfully our over the as considering allow in build-out elements the attributes we these next the and of imetelstat partners, topline Geron are we upcoming unmet to goal analysis, several significant as plan, well Phase milestones and potential together, lower Putting necessary and These to with as include that the product it has address Phase to risk X IMpactMF X needs. the are imetelstat unique the from

the potential offering. the million. up debt proceeds available non-dilutive to of to to funding after existing tranches expect also to is us with financial sufficient XXXX. to the January follow-on of warrants million in public will from additional of addition debt current strong until up facility MDS in In X and strong secured trial Hercules these This in additional debt we $XXX partnership our corporate approximately and quarter, opportunities of potential to raised we million an of XXXX loan our level $XX in an deliver proceeds disclosure be projected have million topline March Valley $XX a increase our from sheet expected $XX to flexibility added late element expand results potential and resources balance up to amendment strategic to to of middle give we value We additional we outstanding exercises sheet. In our lower early projected past current Bank. fund already I XXXX. believe this as Capital facility attributes total to when consider Silicon additional creation capital operations from the the ability through discussed, risk lead The key Phase should an net year, another that our balance These proceeds in

Finally, I’d team. deeply like to management on our talented comment

knowledgeable XXXX, continue with Regulatory commercial ahead. our Advisor Officer of Chief history as of on hematologic our in and and path starting capabilities malignancies, and Rizo Geron and experienced Medical has an has Dr. the instrumental as been We Feller Janssen exemplifies of the in is hematologic beginning Medical Aleksandra imetelstat working pipeline having her new to Phase trials of to Phase design transitioned Senior From Faye X the this Faye as opportunity to role imetelstat’s clinical a imetelstat introduce build in that program and type briefly our appointment I’d expertise Dr. today. the give designing to call. at Geron as studies management in Faye on management cornerstone to X entire been the the in XXXX employee at driving herself in both studies the expansion recent development like The in Faye well base malignancies. development. in

financial Olivia I remarks. then my and that, Following a will update make concluding Faye? provide will

Dr. Faye Feller

XXXX, of Thank development Sinai medical clinical you, involved the as clinical Chief the Sloan-Kettering hematologist trials way I and readout that, and a at beginning Janssen settling Chip, update. trials in to I is Officer, Phase the for lucky Since and as two at development for X past leukemia an was joining then XXXX have the contact for several physician with clinical at be the will at two expansion service been to imetelstat, well of By point the including for I running IMbark delighted you lead and the coming to am early- Cancer Olivia? our X into I trial Phase since years. in honor involved new Memorial Janssen, I Memorial in subsequently parts before all seven assets a the over the Center. be pipeline we turn It speaking to journey on studies. Olivia financial next my Medical very other and primary physician to been effort AML. Mount At trials imetelstat joined today the medical be have designing I plan faculty multiple am to over for product role. the imetelstat of Geron. an personal of With to the incredible of Janssen. all to including introduction, the clinical kind Geron as to introduction. years, and I trained as call attending a candidates, oncologists, pivotal study in of investigators as late-stage

Olivia Bloom

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

which securities, marketable April Overall, XX, we net XX, approximately were As of XXXX, offering the expenses includes year. months slightly public months year. in this June the overall lower million This operating the $XXX six in June in and period. three for XXXX, underwritten approximately from completed we of prior to million compared proceeds had of cash decline $XX and composition primarily the last reflects changes from activities of ended

months decrease expenses reflects decreased the net for administrative months to topline infrastructure to for and six lower legal six the period consulting and personnel preparations regulatory increased batches, period three results by potential headcount partially to XXXX, imetelstat of to The compared general example, in the the due in in offset higher the and to and personnel expenses the in risk submissions primarily expenses same result results XXXX costs partially net to expenses of headcount. reflects fees, related and for same costs June in XXXX, compared primarily For modernizing for higher of manufacturing related support costs launch additional period the commercial R&D the lower additional timing manufacturing for offset months consulting by reduced XXXX, of MDS. related related the ended internal decline XX,

the for $XXX expect We in continue topline XXXX. securities approximately Under million of at we risk $XXX to full up to the time marketable planning expenses expect operating early in and the year cash results total current lower to assumption, non-GAAP MDS have XXXX. million of

are million we late existing to with $XX in expansion our the Valley our June, up debt and which million Capital This facility in if non-dilutive risk to expand up supportive, MDS of amended year facility of $XX XXXX, data topline access mentioned, additional regulatory to facility million. Hercules potential in thereafter. which from Silicon lower results and in Bank $XXX EU the provides Chip capital filings is to As we expect loan and up U.S the to

We outstanding believe debt added from XXXX $XXX of from proceeds the level funding for lower fund exercise that, financial current outstanding to proceeds currently in projected until of We sufficient $XX additional middle launch additional also project imetelstat from for the now to be warrants and resources in up of potential will With the potential additional to closing million our when U.S. warrants. exercises our in XXXX. activity to include stage-gated Chip commercial operations, potential over projected of turn I MDS will which the risk remarks. call million

Dr. John Scarlett

to Well, what end is an exciting where began, and time important Geron. I’d like Thanks, emphasizing Olivia. for I this

imetelstat’s expect address We the risk needs differentiated of MF. unmet highly with both MDS many significant attributes patients to of and lower refractory

heard times January anticipating early of XXXX. readout in eagerly X a are several we lower have risk you today, As Phase MDS

us currently these has malignancies colleagues this Thank as potential to believe Olivia And bring also open is just to mid-XXXX. efforts, patients into please I the value We takes the my Geron circumstances a transform and listening opportunities. of that market well-funded to very imetelstat set today. has supporting described, much and of call believe to a multi-billion sheet Operator, shareholders. and leader in into potential questions. significant balance hematologic the for treatment dollar you

Operator

from comes first from Kalpit of Securities. Your question Instructions] Riley line B. [Operator the Patel

is open. Your line

Kalpit Patel

morning Good and… Hey. Yeah.

Dr. John Scarlett

Kalpit. Hi,

Kalpit Patel

… thanks for…

Dr. John Scarlett

morning. Good

Kalpit Patel

luspatercept, for more and would color think but you RS-negative in transfusion I Okay. of you this greater closer about real as the guess, reserved Thanks reads who likely be would burden, those in prepared Good to Good to questions. are patients, RS-positive you how program, are who You on for the potential more the use be start morning. stages afternoon. out trial drug sort risk would lower remarks the starting thinking that have just for the perhaps, the get the patients on and and with a world? taking MDS to be that assuming utilization positive, any touched unlikely final first, useful? to

Dr. John Scarlett

Thanks a lot.

comments. be this who will think have taken I few would Commercial by Officer, Anil Kapur, a first best our Chief Thanks.

Anil Kapur

question. Hello, Kalpit. the for Thank you

transfusion post-TSAs. So, addressing in Kalpit, in we which Despite are they transfusion-dependent from a need it research vast patients of need shortened of burden very patients discussions and very majority patients clinicians quality of what burden. especially forums dissatisfaction ability to In have These new durability from independence you address is we and and populations. you poor seeing with they scientific unmet life. as options, relates our clinical of to advances, transfusion as know, patient significant with medical some are are and market, mentioned, high have the the and survival come our of current transfusion this high -- suffer with who clearly high

the with of X durability data study shows TI. Phase Our unprecedented

physicians. important to has which guided by been that We as expect we regarded clinical outcomes XX-week have of the past present in independence data, most the one transfusion

and with modification, on So I standard-of-care stem not their think, we unmet and set the cell expect unique commercially We RS-negative, it TI malignant is, a what ability clear need a competitor’s hematologists for potential and very to both our by be kill success. regularly cited RS-positive and has imetelstat of high differentiated in up but is of big and is products position to the well mechanism action, do adoption, our it as both medical very practicing durability the world across disease real comment indications. across for remains

just here. will I So stop

Kalpit Patel

arm relapsed/refractory best I controls Phase anything to expect if to imetelstat improved the in seen myelofibrosis in days I suggested has the compared data the on historically? should we being one the X past available when from today? controls. in have maybe then And changed we any terms helpful. you. setting delineate historical what’s with very the guess Thank changes That’s relative Okay. relapsed/refractory program, of this just to the what have that historical am to of in comparator trying used therapy survival

Dr. John Scarlett

one. It’s Right. Thanks, straightforward. Kalpit. I will that take pretty

looked So, which data at did study real as were And X were the world who but that the in we a Moffitt IMbark study, does difference. in would a think know, don’t think JAK I matching carefully expect inhibitors since not at patients X And study, synthetic the actually best arm, you exclude therapy in the BAT see available. in we careful BAT, did the at that JAK very I sort the to study to that very exercise, we Phase did of be inhibitors. with who available we Phase also relapsed/refractory study, that we our only much

In arm to IMpactMF very BAT fact, we Phase study the the X we couple study saw a patients. that world using the have of expect times be the to similar in real what data we Moffitt publicly commented in

Kalpit Patel

one if more I helpful. squeeze could And Okay. for… in That’s very

Dr. John Scarlett

Sure.

Kalpit Patel

improve study with … MF rux. combo Phase X the in in

Dr. John Scarlett

Yeah.

Kalpit Patel

is Can adverse the general that any push profile that for thoughts trial you of how or back the of on two maybe event investigators any might comment you be -- going May? guess in from enrollment that I additive started additive receiving profile drugs? on

Dr. John Scarlett

That’s great a question.

am going premature maybe got we and the Way just -- they how to looking probably enrollment. combination So, question this, take of of in going how are talk simple. sort early are about super want of which But, to imetelstat to at frontline? potential about I is you this just pace the first and the Faye, on thinking part, the rux really days, about will I investigators comment of so

Dr. Faye Feller

the for All right. Thanks, question. Chip. Thanks

towards today -- So investigators receive to and from we combination field the and are opened therapy have The feedback we therapy. combination headed of confident. remain three positive two on we continue sites we is

Kalpit Patel

much. very Thanks questions. you Thank Okay. my for taking

Dr. John Scarlett

you, Thank bet. You Kalpit.

Operator

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

Your open. line is

Joel Beatty

Hi. Thanks for…

Dr. John Scarlett

Joel. Hi,

Joel Beatty

… Hi. the questions. taking

or the to how dropout expectations. are first you Phase measures rate to in X or IMerge is on trial are that compared share reductions dose like one different able The looking MDS,

Dr. John Scarlett

blinded we to of soon we terms, and Number all, So, -- enough. the remain we in results pharmaceutical are are study. there will we the two, Joel, pretty much number development first see we one,

about So of or of that. any we interim sort would the study looks comments that not be making conduct anything like any or

done them. haven’t We

I sort out am wait that we have come So, of see afraid, data to of January. will all in early to

Joel Beatty

that sense. certainly And right. Makes Yeah. is Sure. now. Okay. soon coming All

So assuming be down narrow XXXX results -- to remains timeline beyond from it are to trial the IMerge, the to the part what filing you be, it trial and is filing? successful, else of before would what what done able is

Dr. John Scarlett

that. expect specifically, on be say, should we you of Sure. in give that, the filing said the We guess, to a submission, or to of can I I first color bit little We made XXXX. be half the

half. a As while file you usually is at in we the looks that there know, have months expect couple by the Phase of the an the activity data and go -- this it. are -- to a would But FDA of many There then they guidance of from that that given modules first simply I only filing expect. X we There’s officially one ton really the been the relies case. NDA, which in you on as final

has preclinical modules. the worked quality, on the all been extensively, CMC, So the

I much pretty So and I would everything. -- think,

say, why it that’s submitting on I would NDA. we can all head in filing, sorry, comfort terms a the and So kind good have start of think, I we very give of that

So very good we I about feel that. think

Joel Beatty

you. Thank Great.

Dr. John Scarlett

Sure.

Operator

Stephen comes the your Willey next line Stifel. And question from of from

Your line open. is

Stephen Willey

taking for Thanks questions. afternoon. Good Yeah. the

it MF mentioned you the kind with any assume safe I have have On if well? data. partnership preliminary within say imetelstat and deal to wanting would strategies to explore maybe you of opportunities on any had the any that contemplate option know thus Can is back you as far discussions of of to also BD the IMerge front,

Dr. John Scarlett

first. latter the So, part let me take

think, we many -- practice difficult cetera, the but XX%, practically I et mean indications of But impossible. to case, the type only don’t time all any a of are this of think other pretty or there from of probably there not are treating get the be many in would extremely that XX% split also split kinds of be know, certain because partnership indications perspective, physicians I diseases and investigators same, impossible here. opportunity. would as the I getting in biologically it

both everything would as can So that we huge drivers. indications you involve I and assume value if both see think them

really Ed we year. The Chief Obviously, can’t second comment question, have -- our a on. end the I of we Koval last as at Business hired Officer

appropriate imagine to seeing that comments. key value committed can that, are It certainly Steve. it we I is not this market, that, say us. it driver be others We to benefit a and patients. he any think We You beyond the believe for brings very us would huge except make product remain obviously But remain for to busy. on to --

different in of least be will So some suspect that at or be when after next the will all I of cards options of the available we look at the beginning year. -- turn available the some

mind launch fully I very be robust and will expect that we keep whenever in to group out so on are think we the and that have building and prepared product opportunity we enthusiastically. do commercial a time to

anything Anil, know, is that don’t perspective? is should else your I So or from we adequate that there say about

Anil Kapur

perspective. to on Adequate from add Nothing more that. my

Dr. John Scarlett

Okay. All right. Thanks.

Stephen Willey

overlap study considering side? And with get telomere of drugs tox the the a venetoclax study then along those starting curious hem in us study, two specifically so the of will is, with dose think investigator-sponsored on some just guess, I you follow-up, tell combination in just how be the AML. will and Can the you relapsed/refactory that on imetelstat which

Dr. John Scarlett

AML telomere is but or crystal pointed I you it’s in I AML, quite that patients, asking am but out, right? what just you Faye, Yeah. think rightly going post-venetoclax to to clear, treated as to over about? post-azac relapsed/refractory turn that’s be And [ph] itself were in

Stephen Willey

in post-venetoclax? it’s So

Dr. John Scarlett

Yeah.

telomere. So Faye of can explain the design

Dr. Faye Feller

Thanks, thanks question. the Chip, for and

HMA exposure telomere and or can have previously venetoclax to have in and/or had of AML may or they So is relapsed/refractory them. not either patients

release we believe terms in that dose, could of don’t the publicly. So I

on course, comment cannot I Of it.

Stephen Willey

is agent. it single But a Okay.

Dr. John Scarlett

can, It’s… we But yeah. Yeah.

Dr. Faye Feller

Yeah.

Dr. John Scarlett

we clear, Faye, combination parts combination, in AML, It’s venetoclax sort there two of it’s so -- it’s in also in in combination… just it’s the and or so be it it’s with there. can But are -- to -- crystal right in

Dr. Faye Feller

is part in One combination…

Dr. John Scarlett

with … azacitidine.

Dr. Faye Feller

venetoclax imetelstat and combination in another and is and imetelstat azacitidine. arm One combination is arm

Stephen Willey

Okay.

Dr. John Scarlett

Stephen. Hope that helps,

Stephen Willey

Thanks.

Operator

from comes the Blum & from Instructions] from Stephen Willey, next line sorry, question Company. Gil of [Operator Needham Your

line open. Your is

Gil Blum

taking. Hi, everyone, and thanks for

Dr. John Scarlett

Hi, Gil.

Gil Blum

a of will …our direction. luspatercept angle, singular that it attack earlier a A on follow-up different from question. bit maybe I

So this just it harsh based by of a reduction JAK transfusion I for to burden, is XXXX a more despite by that and population luspatercept potential looks status. like you very on Do mean, is kind status there being this penetration, of unmet restricted there, right? expected blockbuster reach impressive suggests is think

Dr. John Scarlett

Anil, I think, your this -- you purview. hinting

Anil Kapur

So, I a are patients really for the I don’t for what almost is market patients, Obviously, in status especially with seeing highlighted, which some time. a advance the blockbuster need. These a disease adoption is means. important Gil, previously as of is know it’s realization through that terms what who can saw -- innovation in MDS, come lower risk the transfusion no I drug decade. But that come now ESA-relapsed/refractory, of on What they unmet significant burden. marketplace really

really durability why, around We drugs for previously independence matrix transfusion and are these that’s medical real to high as the a patterns emerge address really, stated, also unmet need. and I utilization story seeing real these important of becomes world patients

We as for are competitor are up-dosing drugs searching phenomenon seeing they responses. among

I the we differentiated. It both given different, question is out with are high breadth think, populations data around of to meet right. and set that across durability. bring your is is the And need absolutely we mechanistically to unmet expectation you showcase Our fact the that patients, these and really will that going burden, the number transfusion highly are

plus two literally been literature we option. relevant XX%, three out XX% ESA of Patients community population, deserve is so has and the are the for going very really clear. last to patients are So highly these decades to which bring presenting data, the

have all I questions I I try So if that your answer follow-up, here, just if to you Gil, stop well. will answered will and as a

Gil Blum

helpful, of was Thank yes, items. very that’s, had the addressed you think, you. I and That say, let’s summary

Dr. John Scarlett

Thanks, Gil.

Operator

no for And I time. there turn final some call back you over further this Aron Ms. closing remarks. at the to are questions Feingold,

Aron Feingold

We into forward up-to-date so for so joining and progress to you our Thank you time call. are our well. to taking hope to dial look Thanks We much you us all everyone keeping you that the appreciate much. on today.

Operator

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

You may now disconnect.

Geron (GERN) 12 Aug 222022 Q2 Earnings call transcript