GERN - Earnings call transcript Q1 2022

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Operator

Good afternoon, Ladies and gentlemen, my name is Addie and I will be your conference operator today. At this time I would like to welcome everyone to the Geron Corporation First Quarter 2022 Conference Call. Today’s conference is being recorded and 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. would Vice turn and President I to conference Corporate this, Feingold, Aron of at like the to over Communications. And Investor Relations

begin. may You

Aron Feingold

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

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

John Scarlett

us Thanks today. afternoon, joining for Aron. everyone. Thanks Good

X we we're continue over line hematologic believe early two years. the trial a transformative in only patients, the risk XXXX. one XXXX. our imetelstat This underscored importantly, and is provided to Because study other opinion significant X hematologist treatment This durable our Phase other imetelstat malignancies. from minutes. X which in expect represent in Phase the IMerge we to of MDS, In independence, in unmet patients. transfusion potential Phase of product with in seen risk execution data IMerge well results for January about need momentum from the one from we're top XX-week few year no trial advance the significant imetelstat first their from and It’s transfusion away MDS lower are readouts Phase community for the independence. the and confirmed next key a two build significant data the believe the We clinical Most study. speak these safety is we could our I'll on the durability X rates leaders eight for and positioned lower months and quarter, throughout realize the

provide potential both negative positive to modification. as In the disease approved unlike therapies to offers addition, RS well imetelstat and potential RS patients, treat as currently

XXXX. enable X treatment We opening in imetelstat This steady to sites create the landscape data commercial the will to characteristics our risk significant clinical expected broad analysis interim expect be for lower to imetelstat. an making progress analysis We're which these interim MBS IMpactMF readout a for second also in MF opportunity. strongly differentiate Phase trial, is and refractory in

strength AML April offering as including $XX investigator-led capital Vivo the up Management expansion to and represents This to a program Xst. key biotech broaden study We for the to net from the specialist on opportunity the Capital, of Associates opportunities as well objective investors, us A and this base. investment start combination keen pipeline ECORX, goals public investors both of that interest raise indication. Phase the recent internal financial studies closing and our garnered capabilities the enables believe IMproveMF of strong combination with risk momentum. to quarter management the team. was of and our is and Healthcare investor frontline MF, X to X therapy we that our commercial for our other Capital, offering TCGX, data, including expansion the Enterprise That these million study picking public X and RA Phase a the program potential our Phase potential With the additional Geron study IMproveMF compelling readout, two of lower our due X We're additional in pipeline pleased imetelstat Phase flexibility as achieve in in MDS indications nearness provide the our

through Our to plus XXXX. from current planned of the the proceeds net from resources warrant XXXX are additional expected provide this the the resources in exercises end milestones plus financial financing, potential necessary our to funding key support financial

XXXX, of risk IMerge a include application results of key of XXXX half for second authorization top first the of Assuming a MAA marketing drug U.S. from NDA in submission new half or X line XXXX imetelstat European the activities U.S. in of submission Phase a these and positive milestones trial potential commercial MDS. lower and or launch preparatory application

the options. structured These these provide strategies expect debt, maximize runway or to consider as us monetization, current to additional strategic other patients financial include for various instruments, could and of value such the will and royalty partnering also the imetelstat resources projected We cash shareholders.

Before for Geron over value clinical approach execution across I milestones Medical turn and turn the I'll the Chief and With we call It's to colleagues, I'd to my excellence patients over for unlock collective to our Alex? strong significant and remarkable highlight that, very call the like colleagues. appreciation my [Ph] for Aleksandra the that my will competecient for Officer Rizo as company, shareholders. updates.

Aleksandra Rizo

to Chip, afternoon call. Thanks, on everyone and good the

Phase X results lower As our be X risk just of the Chip mentioned, we're excited from planned MDS away trial. to months top-line

if in study readout, are across execution by the confirms population, lower investigators, current has risk collaboration similar approved, failed significant and options. MDS occur or is that quality the early operations, sites. IMerge lower need As who trial with safety, the same designed patients trial of believe everyone remind We remain of for investigational confident and inhibition results, Phase trials for the imetelstat readouts XX% dependence focused for Moreover, many all dosing approximately refractory treatments use address patient requires data partnerships which Furthermore, are and the other our provides MDS X as like We well are MDS. clinical clinical ESA with and same teams, to and teams imetelstat biostats or I'd such, regimen treatment. of confusion, the to confirm secondary could for Phase will risk would our investigators. and on mechanism the that that management the data January RS-negative from primary unique disease durability are sites for telomerase us, high preparations differentiates geographies the CRO potential, to low X currently steps imetelstat who Phase XXXX. treatment risk of modifying with since which endpoints X believe patients imetelstat the and we as underserved needs

initiated our submission results, to In top-line NDA has team preparing preparations. regulatory for addition

to a the first in and U.S. NDA to half second in assuming XXXX. sites Phase IMerge mentioned, XXXX. submit we open in interim of MAA our in With we potential confident an regards X the refract of trial, completion activation selected Europe an XXXX. the support and we the will with Phase Chip As clinical MF site in remaining XXXX progress make of enable plan results this progress We to the continue submissions will half X in and enrollment analysis regulatory remain of believe

trial can is transformative our be in MS overall MF the confirmed primary lack journal, option by a Verstovsek, the in We principal treatment OS the trial for IMpactMF. a to their X only observed IMpactMF respond present of Dr. in Phase survival publication given and X Imetelstat using MS refractory recent that the in IMpactMF of treatment and for who dismal survival paper highlights need Phase lack believe in JAK patients to inhibitors, potentially are reminder, a note, inhibitor and improvement failures. no Mascarenhas many in the in for of dilemma this options. as investigators these improvements and longer cancer endpoint. trial who X reinforces describes JAK outcomes could Of in both prognosis our Phase This co-authored Dr. patient unmet JAK inhibitors, patients poor population. treatment As clinical

X clinical first this in ruxolitinib activity in earlier the in frontline of for stage frontline to the the disease opened we These our for to with study, the improve study. [Ph] want to our evaluate clinical treatments MF. study site this, with on the potential programs month, explore is designed pipeline, combination modification and this MS disease Moving MF in patients Phase safety we imetelstat setting. imetelstat earlier In in in

receive As parts, reminder, improved showed study approximately the In efficacy by Parts identified efficacy safe safety patients confirm to experiments. preclinical further and ruxolitinib collected. two objective and will synergistic additive One enroll a and of open part we patients with collect schedule part MF XX drugs single with with that patients in followed also In the enroll to both with the to identify are data arm plan of in in to and up parts. one, MF a dose the objective dose imetelstat data. being two dosing while label a consisting imetelstat, combination who of frontline a ruxolitinib effects for patients two, XX the

Medicine, in XXXX the AML, pediatric continue the in from acute trials the and led of to publication recent non-clinical our Clinical diseases. higher Journal expect second risk further the in MDS or start supports imetelstat of myeloid in investigator our these For developments AML in leukemia, we although half

believe that on Lastly, on-going likely Ukraine our for line Russia clinical impact and activity At the to call we have comment limited over Bloom timelines, and turn our across X, will our and conflict financial Financial IMerge for like we our all enrollment in want the to IMpactMF. would I and no Chief update. Officer in analysis results have top Olivia? for questions, including to now that anticipation trials. Phase the Olivia significant trials or moment, of trial on interim I

Olivia Bloom

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

our the quarter to XXXX in expected, launch, April period same driven compared stock general On financial related higher us. of lower internal XX, March and payable expenses. partially XXXX, increase securities. The the headcount. hire expenses an to the expenses expenses to resources, net to XXXX, operating development which other line reduced period personnel overall our expenses with and Chip first increase XXXX, warrants The underwritten period infrastructure that by additional to of modernizing for in and approximately the costs of quarter guidance we was for support are the million result approximately there primarily call. of common offering the offset for in the X, compared legal costs to of expenses marketable by related and closed As by operating first XXXX, million and in primarily in we additional XXXX, According cash compared the headcount. R&D on for was financial financials, in commercial net decrease related personnel the as underwriting fees same our administrative higher proceeds $XXX.X same XXXX the had after quarter in reflects public and deducting discount, The in earlier $XX estimated reflects estimated primarily in first mentioned

for at associated due results execution expect IMerge expect X the early to fiscal well existing The million XXXX. impact of readiness have as pipeline the line our financial in we imetelstat with the non-GAAP to X the expansion in security Phase expenses, cash costs clinical up new our in full operating total Phase guidance continue time preparations. support to top With clinical results financial XXXX. activities marketable million financing filing reflects studies year and We XXXX pre-commercial on as for top to MDS $XXX year and additional approximately lower-risk regulatory recent the to and line of resources, from and capital $XXX

When financial and of for Chip We up as on the XXXX milestones regulatory be plan preparatory beginning of I activity $XXX the low U.S. expect balance the potential XXXX, Chip? at to million exercises and to additional hand in for closing of risk These sheet million first added remarks. will outstanding in filings MDS sufficient call milestones and the XXXX. potential to projected also through the the include of commercial the now launch end warrants. projected funding risk we back the low MDS of $XXX from in currently to project half imetelstat for With in U.S. well as Europe, that, XXXX. in resources

John Scarlett

Olivia. Thanks,

you've call, bring this important significant As and deliver throughout shareholders. execution an which of key milestones XXXX for on to believe year patients heard will value marks to Geron we

call for attractive we over believe, next company two significant markets, X So I'd to results where this expected X We stand reiterating compelling like Phase supported today. readouts to our end with data we that is intent and by commercially in as value registrational a the well-designed with two trials excitement by have Phase create years.

milestones positioned regulatory to for with imetelstat cash opportunities on indications have regimens. of pipeline XXXX. runway believe clinical well the we're through We projected key combination in program We and financially end execute expansion additional a representing

to capabilities to will value open ourselves as value employee hope Thank team, MDS in And a following the We well for line management bring and from and launch we experienced early maximize And imetelstat to as of future patients the and expect potential risk commercial to shareholders. establish Phase prepare expected for deep building patients base that hematologic a is our for our half optionality that belief you enthusiasm results have as questions. shareholder committed please the create We're listening suffering you U.S. first XXXX. call help strategic as in lower from X early XXXX. a for runway trial for passionate, the as a today. highly company, January provide top our share I staffed focused ability of our understand our operator, Geron malignancies. and deeply for to

Operator

And with Company. take Instructions] Needham first you.[Operator our & from will Gil question Thank we Blum

Your line is open.

Gil Blum

afternoon, questions. taking Thanks everyone. our for Good

that study, the by maybe do [Indiscernible]? example approved in additional a the So in time that setting MF that think on may positioning like for up no how for imetelstat drugs look quick of one you might line second be a

John Scarlett

I to think take Anil going question. is that

Anil Kapur

Thank question. you, for the Gil

So Gil, multiple the space think evolve under to importantly, mechanisms investigation. continues with I

treated also cytopenia dependent symptomatic for combination addressing the of [Ph] a patients study. severely and eligible that therapies, needs expect We be is fragment to a Non therapies population, transfusion patients the patients allotment our address patients. represents in with approval of which

it a research looking effort primary the you market at be KOLs, largest expected Our refractory compelling patient physicians, with expect if the know, study all the myelofibrosis. our proven, study, only the as Gil discussion remains is overall this a of is become JAKi for part are standard-of-care ever and to as in would with and population, to myelofibrosis results survival a endpoint. study highly we In

Gil Blum

differentiated, this lot That know endpoint makes related maybe a sense is a question. definitely of to

any the realm? more So assessment the little the combination kind notice like something outside going which usual response rates Rux’s we're at SVRXX be is TSS endpoint and frontline or is of that to of a and on SVR Thank thoughts I you. a primary looking study with other endpoint

John Scarlett

take Alex, Gil. that will Yes,

Aleksandra Rizo

Yes, thanks Gil.

So, want species drugs, to that that study, part first Phase these X identify again, repeat combine a dose dose. finding to the safe we dose. then [ph] two confirm want the a we And we confirm in can the of second let's study,

in out is myelofibrosis will there, will data we drugs biomarker addition So all believe distinguish from data SVR be collecting we in and to PSS, efficacy know for known we every while development. that which we this, we're the collecting doing for other be

marrow this assessment a one, I fibrosis as right PRs be data, for well. or and is as think we data will and will potential be be will fibrosis collecting conducting yes well. PRs seat And So we in that improvements

a collection So comprehensive it that inform will will on be we data next steps. believe us the

Gil Blum

you. That's for Thanks our very helpful. taking Thank questions.

John Scarlett

Yes, thanks Gil.

Operator

next our Stifel. question we'll Willey take Stephen with And from

is line open. Your

Stephen Willey

is the [Ph] Yes, frontline to efficacy follow just toxicities with just intention the up thanks know the follow for on taking but currently you of for here And what IMproveMF. second potential respect up. then disease given a the is in questions. very patients with a patients, ViroXis bar I Maybe for and curious to the modification just think the incremental evaluate question is treatment on symptomatic frontline tolerance here, improvement. focused last

Aleksandra Rizo

Yes.

John Scarlett

Alex. ahead, Go

Aleksandra Rizo

Steve. take one I can that

that believe So couple I are to a important mean, make. of I here points also

in safety terms So very or of thresholds toxicity important. are

Our drugs are thrombocytopenia. do we starting overlapping have And that for very reason, carefully.

imetelstat. that for think the this I of stabilizing we combination. they're And then we're we adding the dosing and best first, tolerated With the dose believe two we with approach, will the find know drugs, Rux

for in frontline, of right, and well. efficacy, hope will But improvements modifying to something in In reduction other we the they're to take in, in that, disease that, the see, the of bars addition potential line are different in our TSS. other are, in that again, I in is position right, believe set being drugs the we we when set development. think And improvements second hope the [Indiscernible], terms than as SVR in we a drug, or in no, terms we'll the fibrosis, see

Stephen Willey

just at if seen of frontline secondary so, the refractory frequencies the can in the that respect mutations? of endpoint. kinetics Okay, disease JAK drugs, same the the a is know at patients bit assessments patients? observed you on -- fibrosis, real a are those and it's in same me kind modification to also subjective these Would you assessment I Can be and does of going patients, then marrow be looking that these undergo are you to And remind rate with to and fibrotic the requiring patients?

Aleksandra Rizo

address we’ll them So good think of couple by I our one but couple, you one. very points, had

well on is fibrosis have fibrosis that various frequencies we we marrows way we done collecting will and continue mutations. to assessing plan by study review so our for on to assessment do as done same independent as allele or as it far, assess be we well So committees. the The

is, the fibrosis some confident while us kind a in makes having the I data that collecting assessing. people done of an by doing about think subjective, say will we're which So and we or it improvement IRC, job fibrosis good that fairly be

So, yes right. to fibrosis,

an he will with doing samples addition And assess review be two these that, frequency. in manner. And So to coordinating collecting are outcome. allele we this we will the be in to independent

the line I which they in -- discuss because, to your disease, these front same in Now, have would in the in think second these guess patients the characteristics. whether occur molecular I disease ones we'll But mutations it say their I line would to higher their whether the to have will, progress, frequency last question are mutations these to as tend setting? be lot nevertheless, a itself, right. risk linked and of

So a as the so do HMRs the the know would all exactly frequency I like just I But mutations least driver combination that and itself, over example, of increase the each them, for progress. and of patient’s say don't at of them. about of time

Stephen Willey

Okay, taking the helpful. that's questions. for Thanks very

John Scarlett

Thanks.

Operator

next Baird. And take Joel from our question with we will Beatty

open. Your line is

Unidentified Analyst

Hello, the you. few a just coming and questions bit maybe you Thank on you for describe a in in of IMpactMF, number enrolling Joel, provide of maybe Could us. sites color this physician online? on patients is of can for Benjamin little engagement level the

Aleksandra Rizo

one well. as take I'll that

selected year. of expecting know. as I'm do. we And So than where the number this think space our rest we so that there. you size is we're confident to sure we XX% is the remain I the the that's don't we've far sites competitive, think by the will really The is put open by what is sites. what have I that of of opened end this But is guided do more a

right primary we, which endpoint in repeated overall do remain the fact do taken see endpoint, space that we multiple an enthusiastic this an We really is PIs a have has -- about direction. needed that is our moving enrollment, survival been it as in times However, the and it. we

Unidentified Analyst

more MDS. the lower-risk for prep Great, early Thank the early then dissipated any underway just January? one on in thanks. Are And readout commercial there you.

Anil Kapur

that Anil, take is this question. Joel, I'll

for as educate base, action. treatments coming the will bring effort are extensive data extensive really market of start I more unique is as a the yes, see next time, underway around characterize the all TLR post months, of one to efforts, XX the They're gated vast also physician physicians reminder, risk to there the is the over where all market, commercial imetelstat to us low a you as see and that and our we from MDS. So which understand mechanism to tailored well. And hiring majority want post start

to if answered question. So your stop I I'll here just see

Unidentified Analyst

Thanks.

Operator

next Securities. Riley take [Operator from question Walsh Instructions] And will with Justin we our B.

Your line open. is

Justin Walsh

and frontline Hi, frontline can any some anticipate they thanks for for having to relapse? hesitancy a IMproveMF, patients Rux’s you taking the starting with questions. patients MF given respect inevitably alone With that about time provide before do combo benefit

Aleksandra Rizo

question. that can see think additional treatments from with they might with have that they just benefit don't have imetelstat. in for Thanks you I why to that addition I benefits know know, that, you Rux

So hesitancy that. we we have have about that nor not heard and concern any

John Scarlett

ahead, Anil. Go

Anil Kapur

Alex what multiple trials phase them to on upwards add JAKi’s. XX to of with combination strategies just underway with in trials myelofibrosis in of frontline said, there three So six are

mechanism. data itself. to starts potential So hope what we IMproveMF a the our to expectation novel the non-JAKi bring the modification establish as for disease table Overtime is to is with would

Justin Walsh

just may there be concern question. in challenges you be Do be mentioned? enrolling since And that those all on my other it. trials building you Got last that have as patients with you competing that will of will any

Aleksandra Rizo

which for sure not I’m study you’ve…

Justin Walsh

IMproveMF.

Aleksandra Rizo

frontline, the for IMproveMF Anil.

Anil Kapur

but guess IMproveMF, could we IMpact as for that’s well. in I true

Aleksandra Rizo

with and think don't frontline less-risk distinct should the disease enthusiasm to modification so. even the the the that Because I these benefit right again, patients. – value, It potential the right? in drug bringing better, refractory patients The survival are patients. really for space. for I Right, different think overall offers don't and – so. respond mean, I

investigators. still both [ph] and to it's think I BI uniquely attractive

for is I field So good do a with enrollment. believe. that problems at couple But reasons, least don't competitive I we The out of nevertheless. spend expect with any

Justin Walsh

Thanks Great. questions. taking the for

John Scarlett

Justin. Thanks

Operator

Feingold no would to Aron closing this like back no I questions are there call turn the remarks. to further time. at for And

Aron Feingold

your look forward so keeping our to for progress. you Thanks today We See for all. to us much and on posted everyone joining questions. you

Operator

And ladies concludes today's call. your may for participation and We conference you you now and disconnect. gentlemen, thank this

Geron (GERN) 10 May 222022 Q1 Earnings call transcript