GERN - Earnings call transcript Q1 2021

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Operator

Good day and thank you for standing by and welcome to the Q1 2021 Geron Earnings Conference Call. [Operator Instructions]. I would now like to hand the conference over to your speaker today; Olivia Bloom. Please go ahead.

Olivia Bloom

Great. good and Celine, you, afternoon, everyone. Thank this XXXX Financial to conference Events. call Quarter First Geron's discuss Results to Welcome and Company Recent I Dr. by; am joined today John and Executive and Scarlett, Officer; Geron’s, Chairman Dr. Chief Officer. Rizo, Chief Aleksandra Geron's, Medical market results press website. financial the quarter on is via closed our release, announced After first we XXXX available which our today,

an addition, for webcast days. this XX available be In will of archive website on our

outcomes time and risks and statements now turn uncertainties those speak as not differ explained Exchange for the on permit change. all not year not be that Phase III basis Scarlett. information the before XXXX the the the the may session made, Undue may and and Geron's it and and to underlying end additional NDA; is uncertainties modifying; lines, include, begin, quarterly on the for demonstrate challenges enrollment, not and the note expected completion scientific, statements to limitation, those technical, IMerge further differ imetelstat safe those unable And meet of statements relied to and clinical, from to resources Commission. prove course and III resources statements. Geron's between limitations, actual forward-looking of that cause to million and are disease-modifying will or These question-and-answer III $XXX that due contain from the actual risks otherwise; regulatory its imetelstat of and in burn and Phase please above IMerge and and and IMpactMF; without lines be to without a fund materially and risks, II the Phase operating of may John? forward-looking only potential cause trials statements uncertainties financial with imetelstat manufacturing XXXX, March XX, for regulatory enrollment clinical to efficacy, million potential efficacious not has from imetelstat. and sufficient approval date we may of of to and financial that current Securities until Dr. in the should and IMpactMF expectation uncertainties Before forward-looking the involve regulatory operational, $XXX MDS plans, over clinical may placed ended could imetelstat will forward-looking forward-looking safety, and expected forward-looking the assumptions that potentiality and commercialization; COVID IMpactMF results timely or development Detailed I Form the filed statements efficacious and the as can heading Risk and or authorities the are presentation facts need III time may the safe, of other for the will XXXX call in Factors the will the alter expectations, XXXX; the IMerge be commercialization and beliefs, be of such and and that its of in regarding that which the all and overcome clinical be expense they MF. risks from be trials it the commercialization; to in include, development that to disease company for that the authorities of projections. in Geron relating factors report on at Geron's and statements Phase may trial this for submission under Phase positive of by trial, additional materially as end an on the potential results time XX-Q These operations lines regarding that results those approve These

John Scarlett

Thanks, and everyone. good Olivia afternoon,

the During XXXX. of first quarter

our We registrational in make III two studies intent. to with progress Phase imetelstat continue

in had XXX of half the December, have planned our of agent completed of who as report happy ESAs. III patients trial refractory continues Phase we relapsed imetelstat to to First, ongoing trial. are enrollment IMerge or and to I'm this enrollment. today, in of increase or Last low-risk transfusion-dependent, enrollment we achieved XX% now erythropoiesis-stimulating This is that planned MDS trial. patients, evaluating the

for We top to available of XXXX. early end enrolled XXXX. in of to half be this year be continue trial fully the expect as as line first in this to the second of half results We're the and

the that's are refractory as continue be III to expect we trial inhibitor, complete primary in of overall our intermediate refractory with XXXX. first is risk trial in for with our enrollment a treatment This MF dosed. patients it's to prior current to Next, trial in the XXX Phase we of first or IMpactMF, this the announced with patient high recently trial to kind evaluating patients on Based patients and imetelstat being who endpoints. second myelofibrosis, planning assumptions, survival planned the JAK

for activities, developing we commercial progressing well lead include company. comprehensive organizational a a time foundation high as long on our readiness, preliminary as manufacturing which and Next, growth stage NDA are commercial to activities in support and quality

II that on new two be the available will submitted. presenting EHA, meeting abstracts analyses look at at European XX. and we data we May Association trials abstracts The from upcoming Phase Lastly, imetelstat forward Haematology online the with to our .ehaweb.org

With call remain in approval turn Rizo. to regulatory top Aleksandra Looking IMerge ahead, I'll three Aleksandra? commercially III, Phase committed to the next line that, MDS. years, launching gaining this drug achieving differentiated over highly imetelstat we and low-risk results of over the in

Aleksandra Rizo

and everyone. Chip, afternoon, good you, Thank

from data, who Phase available patients, imetelstat the to II currently low-risk for we ESA. MDS As our is treatments compelling relapsed refractory by clearly believe or supported are differentiated

as have trial, Chip III Our planned XX high numerous we duration transfusion mentioned transfusion treatments publications of including enrollment. and imetelstat, previously, meaningful now within a of months. and in XX% IMerge patients independence durable independence presentations the burdened transfusion have our after reported median In of Phase achieved

patients decreasing of severity see their leaving where becoming located. in COVID You rates, sites many of cases participate homes are in trials, of countries, as clinical reviews comfortable positive number our more and of are will the increasing vaccination to a

Moving developing in Last milestone longer first indicator on month second inhibitor overall treatment, III for have This clear is Patients important the trial. or to imetelstat the approximately no in population. this IMpactMF. It we was dosed an in following patient our refractory respond to trial, unmet Phase fail of that myelofibrosis patient who JAK a XX XX a survival months. to of needs median patients.

endpoint. the refractory in is study IMpactMF with as overall mentioned, Chip MF survival only a As primary

study Hence of event-driven. the events analysis we've period. death from is the analysis this throughout XX% conducted IMpactMF have will planning could plan number the more final of the required of than Based to enrolled on is enrollment assumptions, as The before number these occur total occurred. be to patient's guided. for conducted planned be to previously analysis our trial interim the planned events results As the the events remains same as study final is expected interim died. analysis be to after timing for have projected XX% enrollment in current after approximately of of accrue conduct is the complete the timeline

currently to activities plan in to five over site recruiting potential and analysis around patients strategies to is patients. IMpactMF the for used Phase the and with III. staff world We employ physicians will to in We in across an the that XXX We're IMerge Among plan benefits clinical and actively similar analysis final enrollment XXXX the their XXXX. sites occur projected retain site for continents. be enrollment, we engage interim initiation Before boosting interact others, participating IMpactMF. of to conducting

this presentations also Virtual utilize Congress our from The potential investigators the forward for awareness again for week. patient imetelstat's present these in drive EHA abstracts available clinical and XXXX will II recruitment. be This social redefine help I will June to when highlight patients. We trials. look upcoming new data to media standard-of-care tactics analysis will once MDS to and our and later presentation Phase MF the online

financial to Now, I'd the results. over like our to Olivia? first call Olivia discuss quarter to hand

Olivia Bloom

and Aleksandra again, Thank afternoon everyone. you, good

quality in activities, validation for include in As end the The operations fund such higher expenses company These higher associated and quarter for first Phase XX, are primarily in manufacturing approximately our compared driven well in long $XX validation security, down $XXX increase of enterprise expect in XXXX also the manufacturers same contract as ongoing two provide R&D be at Phase conducted clinical to of with as XXXX in the XXXX. initial from trials, III a imetelstat and the development XXXX. by which with we manufacturing into activities and expenses for NDA potential will XXXX administrative assuming XXXX, debt slightly collaboration efforts. we had lead-time file quarter increase imetelstat topline to million our order the data cornerstones March the the by the of in fully execution imetelstat. the of to planned of operating batches development and our work initiation shelf-life of in both commitment. costs our of $XX million and increase III. as potential clinical ramp will same that XXXX in period period expenses increased This MDS rapidly launch. prepare marketable to to sufficient information for the XXXX, facility support lower-risk drew was commercial until of size expenses. This the cash in reflects complexity be of commercialization main September will transform time results Geron positive we expect General to million set batches product These which to validation IMerge compared first the of an Upon our in

As expense was quarter the $XXX,XXX. of XXXX such, first for interest

foreign concluded the in a contract in if change, adjustments. of and manufacturers, guidance metelstat we've our we in to $X.X the Chip we the to net and other I conclude first investment, of filing from guidance; by an for and company's reaffirming and assumptions like net that, a all will our time. the trials, produce our be guidance operating comments of commercial of of translation time, hand holdings million, plans at that call preparing These to readiness. continue ongoing equity to prepared lines on will III revised, then Financial Phase currency With back burn financial resulting XXXX range clinical operator validation For quarter approval begin in point two assumptions including the to regulatory for afternoon. XXXX, based to ask questions. expense set causing this remarks expect a of at realized $XXX at I'd is open cost burns income update sold to we batches to million includes $XXX million. support my gain

Operator

Securities. Riley Instructions] from the B. [Operator you. of Thank first We Walsh coming question Justin our have line with

is line open. Your

Justin Walsh

for to thanks the III color us trials? analyses Hi, on some expect Phase at EHA you give progress. the congratulations on and Can read taking can types question, and what of the we through central

John Scarlett

I prevent think, that on abstracts content unfortunately embargo or from rules happens us on really Justin the until Wednesday. Yeah, EHA the they're and published their commenting

that time. we in at So point to expect comment

Justin Walsh

just right. as if what I'm the if I see we you expect in All itself? abstract comment the data be for you Then maybe don't the this. conference same can that wondering will cut-off on know the

John Scarlett

Alex you comment? want to

Aleksandra Rizo

the would commenting online. would just for but refrain abstract I I to from come too, wait

Justin Walsh

your on then -- the enrolling have current are would you'd I'm and thinking therapy think rapidly you patients more you therapies that quick just your that's Thank potentially I'm you're have IMpactMF best some enough right able question Okay. assuming just one curious, in do enroll criteria, receiving be you. practice, having then that survival challenges I'm that then. change who investigational here not if enrollment that And available do for or in correct to that analysis? implications that that, I'll

John Scarlett

Alex. ahead Go

Aleksandra Rizo

on trials, suggesting your No, At we on how as wait correct. therapies. come we to allow have patients But to well. on typically on will clinical investigational are things Right, do moment, just treatments you enrollments you're do allow evolve. not and investigational see trial that the other not

Justin Walsh

you Thank it. the Got questions. for

John Scarlett

Justin. Thanks,

Operator

Bonnie of our We coming Stifel. from question line have with Quach the next

open. Your line is

Bonnie Quach

Thanks. thoughts Bonnie of towards enrolled? is have you with Stifel. any that enrollment more a since willing for just from course seeing This and transfusion the additional helpful? a small IMerge skew of the patients in those burden the risks take few population would Willey and do patient more a also, a clinical hospital they're the would trial? to about do example, to Hi. impact effect have type in COVID COVID. I of trial of And higher anticipate on on partaking And, think Do patients? Steve luspatercept color at the be the Any on questions going of you

John Scarlett

Aleks?

Aleksandra Rizo

take that. can I Sure.

of, and maybe I’ll of I'll it's I an your give answer enrollment questions. first two interesting, the so viewing to think, overall, specific So, kind then

that COVID-XX resurgence, So are that right? the number in although, well. regions are And of experiencing other coming declining have the that are are as we regions, up variants then seeing we cases certain these is new

it's really clinical or the trial, So normalize. the unpredictable the really which -- about may pace the at of uncertain it's for instance, --

trial, However, in is moment, the that's it are good likely that, that enrolled with we right, to at very is just that. you to its a will these it's patients. on difficult in that higher patients worked say burden -- maybe side a clinical transfusion speculating well comment really be The stuff

it. about if had I on trial, worried be them So we the wouldn't

sorry, one one. on was kind think I'm I'm I So breaking And, of your other questions. the that of

the patient label luspatercept presence robust, this needs population. possible all great. MDS The launch in and was of sideroblast. the markets in low and right? mean, of the irrespective RS- luspatercept the ring Whereas enrollment of is in unmet that doing validated So Remember has been effects one RS+ -- is only. potential I All allows risk -- the patients that trial luspatercept. for for our luspatercept sorry, patients, the and

which the patients. small are more portion or So risk than have it's MDS in let's expect majority while low on do populations the patients not RS+, XX%. some impact that on be impact on the not any there might of the bigger patient to We remember,

Bonnie Quach

so thank much. Great, you

John Scarlett

Bonnie. Thanks,

Operator

Scarlett, concludes Q&A and remarks. portion hand This Executive to call for the you. closing John we'll it Thank the Chief over Officer, of

John Scarlett

for much very thanks Well, joining today. us

are the potential dial this Thanks, become we as sharing risk you MDS the planning and busy imetelstat look have with to drug and very XXXX We're and We're with patients. company about MS launch a everyone it’s and both a afternoon. year. So Geron through to important risk the earning low appreciate to we been MDS. progress bringing season, very progress good The forward refractory We're opportunity and updates participate. low so in excited of markets had for attractive we're who the highly we the for to more commercial making. everyone,

Operator

call. conference for today's you participating. concludes This Thank

You may now disconnect.

Geron (GERN) 11 May 212021 Q1 Earnings call transcript