BCLI - Earnings call 3 2023 | Brainstorm Cell Therapeutics Inc.

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Operator

Greetings, and welcome to the Brainstorm Cell Therapeutics Third Quarter 2023 Earnings Call. At this time, participants are in a listen-only mode.

As a reminder this call is being recorded.And I would now like to introduce your host for today's call, Mr. Michael Wood of LifeSci Advisors. Mr. begin. may you Wood,

Michael Wood

update. thank a for financial press quarter a the and today results us. Brainstorm third corporate including XXXX issued release of you morning joining everybody Earlier for Good with its

the the remarks. the Before operations company's XXXX clinical passing collaborations strategic it descriptions, of will sufficiency capital the to technology NurOwn business to treatment its the as efforts. of forecasts, the to company's existing partnerships the call and market and projections listeners, as clinical conference of beyond, resources statements platform, numerous Cell operation I'd its Therapeutics and ability potential such for this for safety and to disorders company related remind contain business continuing as trials like planning of management programs and in off develop the clinical support potential, prepared regarding NurOwn and development statements, effectiveness regarding performance, neurodegenerative well Brainstorm future ALS,

are update go like from Forward-looking may projected I'd Mr. described Mr. ahead. to Co-Chief forward-looking which Executive including Officer.So, uncertainties and the call and subject many materially Chaim company's to Officer; Please results call of Financial the publicly Dr. turn be any now filings. those today's the Lindborg, company Stacy the statements.Joining Patlis, call Lebovits, differ obligation will Lebovits. CEO today on us Brainstorm; and President no risks and The Brainstorm's of to from and are Alla SEC over company's beyond uncertainties, in on control, statements undertakes the time-to-time numerous risks to Interim

Chaim Lebovits

to us We're all our to discuss results XXXX goal ALS available making Thanks Michael. NurOwn committed of and community. QX the to to ongoing you, have financial who joined progress. our Thank

with from review. in took the path decision was work and with for This do is used action we made NurOwn following review power meeting align our to announced next of coordinated to everything is a FDA few the forward.As step conduct BLA to the without official the a FDA. to that on and to as the withdraw submitted committee This us a prejudice.The with the We've FDA outcome in now NurOwn important previously, priority Our made was ago. decision for place the September. will by FDA days withdrawal be request a the just the FDA advisory

design meeting. ALS intend will study We the next for opportunity Xb we use steps, the confirmatory which to such at conduct in Phase discuss including a to

targeted intend agency elements critical in planned path believe well the headcount program. realignment and the announced endpoints room ALS well likely the Protocol operations and we The on once a and entry of regulatory agreement in we and criteria, raise position clear SPA the clarity our actively with before capital, non-dilutive assets various to reduction strategic we and of trial as getting XX%. streamlining for as to technology.In Special the This of on number that in a design, indicates update such patient We'll clean steps, exosome with noncore a process As meetings will analysis. October, exploring safety having items trial planned resources believe the We the de-risk grants aspect parallel and have FDA options place such seek company regulatory and as Assessment are the planned as certain including take the We're part regulatory We as including a strategy involved team or have ability the conserve to forward.In the adequacy we finance these resources. trial. thoughts our how to X as future. with an capitalizing our prioritize fund the with the of management continuing with Board our X to provide ensure SPA approximately registration FDA. will ourselves activities, of success our of including the

most will to Importantly, XX% in senior positions will us, trial consumption took Xb cut are planned wages. managing all Many estimate XX%. the realignment that retained.We cut overall, regulatory and be total strategic approximately their Phase by critical those including the management resource that submission a of

XX% myself, for were for a now. over took decisions. difficult, but cut I These As necessary

the additional for for the in our all thankful at very Dr. of are Stacy over commitment advancing to colleagues contributions Brainstorm and the comments. now call hard for We NurOwn.I'll Lindborg work turn

Stacy Lindborg

urgent Thank of There safe reality this data confront body to NurOwn a disease. and the valuable and participants, considerable of patients assembled new We've product that for ALS approved, are on and treatment we in Every disease. day, for if continue effective. potential believe has be new to living this people with need ALS, this families option treatments for harrowing terrible the an a remains you, Chaim. treatments that their

are courage bring FDA patients ALS and engage to lives.We that believe with a trial conducting and improve driven confirmatory product market Chaim? by can opportunity efficiently We the look possible. the motivated were we their to forward the by as Phase to to of Xb as a continuing

Chaim Lebovits

Alla ask Thank you Stacy. so discuss much, I'll our to Alla? now financials.

Alla Patlis

of Research loss X X expenses it approximately share per and XXXX. $X bank $X.XX the XX, ended approximately months as or a X compared December were million XXXX for Chaim. million to $X.XX per million, approximately raised ended direct and compared offering. back and Chaim. September respectively. million million XX, $X.X months XXXX $X.X of September of loss in XXXX.I'll months and Net for expenses short-term were approximately XX, and XXXX, of X were July the for million approximately $X.X XX, Cash, for respectively.General registered million XXXX, cash as Thank September the $X.X the proceeds approximately the XXXX the as and $X.X XXXX was million, net million XX, In XX, you, September ended net company XXXX, development September share to months ended $X or $X.X turn administrative $X.X to deposits equivalents and

Chaim Lebovits

read Michael much, from LifeSci we Wood Alla. investors. very received Thank from some have will now you Michael? questions

Michael Wood

Thank an NurOwn, there Is you, the around with limited positive for patients grant where observable been approval the has even FDA could that possible AdComm response? it ALS Chaim. early-stage decisions

Chaim Lebovits

Stacy, you want to take this?

Stacy Lindborg

we would Sure. regulatory with form get the We gain the as forward firmly that started. Xb interest believe never generating we can successful if BLA weren't it's to data our of of as discussing we convinced trial that Phase to in in that move not the best NurOwn. path been would the forward the that additional Therefore, withdrawn data alone. we've the be only will current trial We have quickly approval is

Michael Wood

as long or come how to before a about to you are for question, grants your study? you hoping in can plans? follow-up are funding more know the Next And that, to commence start waiting Phase the funding Xb? when before you you And

Chaim Lebovits

you. Phase ensure parallel and who funds ability are this company Yes. raise bridge needed working to work the work raising as like they trial. Xb have a as run confident stability secure for to very companies first in a funds banks Thank We're funding trial. including in our BrainStorm, for with biotech been to secure to We'll successful, recently, to we the

we're shared we of prepared exploring including remarks, grants. our a variety in and As avenues, partnerships

to a trial funds, we stages. raise chance money always the infusion is there of for the in larger expect of Although

to to intend this. We'll not start the raised do be patients but also until trial full thoughtful than deserve the starting We the more amount have wait we about needed. trial, urgency

Michael Wood

Thank you.

FDA? with on Are new you working the parameters Next the trial question.

Chaim Lebovits

Stacy?

Stacy Lindborg

Yes, that's correct.

basis meeting scientific panel assessment from mentioned will Chaim working we've the disease.We seek the and As special a which, this an we've the starts in course, meeting on core trial, to the prepared to next reach community, with of with an us from FDA as trial And allow to the intended of the and discuss design the to to as on regulatory a face-to-face claim primary agreement potentially the program. that de-risk the this trial We the the panel NurOwn, tool steps those ALS beneficial the view will expedited Xb and valuable know, for the is clinical accelerate is BLA. an an people recently. opportunity as advisory of NurOwn remarks, efficacy you elements of And trial. living of this before which in many for for FDA, study a requested aspects on Xb Phase intend design very serve protocol with a Phase a been including the of a focus will

Michael Wood

with Big partner you don't Pharma? Why question. final one And

Chaim Lebovits

partner. we seeking to are So

fact, we're a in In few companies. contact with

a area successful be compelling, is opportunity commercial from know product would to like rare we Although is this who ALS serve there's disease, and to able patients. the and interest to have a relatively companies in still

products products Presumably major emerging some an still approved is therapy neurodegeneration.There are cell on until that very therapy and especially space remain and though, investments the oncology in remember, R&D will are therapy largely cell disease. genetic cautious. few them to have will cell focused bring the We modality, in approval and

for right did As a an companies and few acquired went you for was and asset, bought the by approval will Pharma while have the de-risked was a remains smaller have Celgene, cell X Pharma Juno Gilead. after by before independent cancer Phase until took years alone therapies company. from and develop partnerships.Just upside wasn't various out may FDA today.We acquired to came same, CAR-T it after approval within then treatments know, the examples, innovation Bluebird many and which developing also attractive Kite

additional technology partnership to NurOwn the with all So to able for promising we any avenue. would we until we as approach, therefore, like we to a were questions? pursue strategic But willing a represents do partnership. open we are as and you comes, will a the would funds to that a call welcome a raise.Jenny, can proceed

Operator

Your Bautz Small-Cap [Operator of course. Zacks is David Of coming from Instructions] Research. first question

David Bautz

or basically, design?" agreement differentiates the if just about a more saying Stacy, SPA. "coming an wondering to could the I FDA So, from trial And about little Chaim that you with talk bit was what

Chaim Lebovits

Stacy?

Stacy Lindborg

it pathway trial, which Yes. approach this, the I and and really that's platform that to FDA to have use that to that successful think the just do approval. but really is to together documented. really out a David, way the but I ultimately the an opportunity the ahead and recognize gives with pathway for it's formal a And we also that the constructive that agreement come discussion Brainstorm should will align, ensure and the I be offers think expect, and work what a be it's formally think we nets to SPA something positive

a So really and interaction, it's about is it formal established well a leveraged. and pathway that's and engagement

David Bautz

as And far ahead. as Okay. -- go

Sorry.

Chaim Lebovits

going I add was to that. on just

that us was have additional that is year usually, so your if do at at day. can a looking get I those SPA far with not there's the want an course, What a SPA. for that SPA. higher expedited pathway to to are what know for But that answer just it as Of or of we're upon take many FDA because able a companies chance discussing emphasize expedited for the FDA, end to SPA approval years to you us reviewed with X just question. to the choose

this talking you Go we're process SPA David, an for question, expedited So had and forward that. on, about another pathway looking please.

David Bautz

of and to at you Yes. off of basically looking kind Actually, time key going the said it's line. just what

probably that would SPA? X, or a at year expedited a normally for process year an then less you're would So be than looking

Chaim Lebovits

to want on FDA here. I in words don't Well, quotes put any

investor be think a the after So I the with want fast. we'll do be this an come from to at what we'll I that But that share SPA. -- meeting. we to see very our be that if cautious. And meeting to by agreed-upon share learn way, very happened should is is. announcing meeting first very the #X see I And we'll now just be meeting, this community meeting soon, we'll and because can That priority we'll when

David Bautz

Okay.

probably won't the the trial but you get be the being it specifics, for one? primary into you to previous Phase foresee understand next for the outcome able I as X was Now do same

Chaim Lebovits

the meeting, let's have it agency the for at that. We're going discussion to keep that have to with so

to meetings like. looks are share those trial an design we once done, We what the and will share agreement, come we'll

Operator

is William [ question next Adventures. Your coming Barr from from Tifam ]

Unknown Analyst

and we've company in following, been years. been We've for investors the many

for A people chapters you've many to going do us So that.Some -- that grateful you've to saw AdComm are really are many time to and finally of happened break the recognizing to been ALS and instead, -- effectuate And continue for treatment We're working that how embracing we beyond the you those all like that that everything done you FDA. hard see starting to have Amylyx of that. done power ALS the to basically everything know been want guys and And are unfair. us possible, we maybe it and all is thought you not was, to fighting, we're investors quickly maybe as ALS the a different? what starting -- patients. they're you of us us of as for my we know at what question believe in really away. and this sue There is so guys it And to Brainstorm know your starting finally was guys of why lot the see also FDA. issues try and is extraordinarily who want be have treatment some and

to different? this time going is be So why

Chaim Lebovits

Thank you. a very good It's question.

want on organization. don't to me treatments first, the So I -- allow for comment other I can't

us, and to organizations them, forward.What supporting work well. is we're that We're I come expedited going we once to I share their trying out it the think listen want you, to reach by the everyone going as to an design on to to with SPA, proposed will have opening and trial FDA have you an with share do be all the to looking that to we're all heard are inputs have agreement and a to statements, in going advocates it different, with and as SPA. have our We

we they I'm them be should align prove been should data. therefore, different more So even seeing. They what see for being provide should NurOwn, will need outcome treat SPA with we many a a want explained, to with in should be disagree therefore, we that.So cautious be sufficient again, to see want forward. overly important that what that they is we discussion that don't on together addition but and what negative to that an what some And what what very have saying, we And are That's we should to I see to seeking we are how to the of trial provided, to they data up has align though what means. approval. what feel just to so provided, acknowledge going are

that an into I So are meeting, get we going meeting. think to expedited going

We meeting getting from are indication this that fast. agency they want to the very the have

to to also to start trial So have another they're very showing ask being interest very us trial and soon.I'll able supporting another Stacy soon comment. Stacy?

Stacy Lindborg

comment read step the a before back our do strongest safety a doubling happen your for meets flexibility. discussion we its I regulatory in and a is look out forward, so But efficacy was on a design, us understand at you we around trial things the We forward that we that endpoints.And we believe, product, product. when can brought given question. and day, the thank William, execute that And have at our there appropriateness the Yes. look us. you data, believe and what see and when that we we believe occurred, think and still end and down. have the Certainly, doing should the the when the we we of we leveraging one positions really that can of what and we and learnings can is trial we

We deliver that a lot in have our gives of trial. we information a lot to this believe ability us confidence of

straightforward that's trial conventional. in certainly, more makes around, focused next than what a regulatory the streamlined that process. the Certainly much so this we're is forward more smooth. product on time bringing And next And

the and incredibly Phase community things this that I that's not tackling learn when different X our were think when the about trial of think We next complicated. did drug appreciate certainly, have in I tough we're last next and understand, what what's is endeavors diseases. to not in program, take think we development And very of now time So there I design. forward we did that things those and learnings this setting as always

Unknown Analyst

have of lives fight just for good us. ALS those our for fighting both thank and us I for you I thank have of you, say in friends, and you wanted lost to Thank the much. you -- that family very patients to

Chaim Lebovits

your Thank ongoing you many for please. question years. really that.Next We appreciate support

for more. time have We one

Operator

Walker, who's a question, private Next investor. Daniel

Daniel Walker

manufacturing. on Comment

Brainstorm And a XXX comment also that. on little centers? rooms on Brainstorm have manufactured has you You that? just manufacture. could the mentioned recent then been successfully I how be about potent to comment some at Town questions Catalent? think just moving the products. ability Brainstorm's meeting clean be there it that forward, Will Can But Will will you it be academic managed? bit Maybe the Hall

Chaim Lebovits

Daniel, Thank for question. much, you very this

the X produced, a you and for have did centers centers for the Phase different commercial been where as we Phase academic at we only X quite So know, few and centers trial already EAP.

The the should first centers financial successful that a have And with are to to do commercial commercial it's want a you forward, Going on cheaper have site the operate. hand, site you centers you're other academic ready. trial, the question. than a once

and to question? the talk So site a have from earlier cheaper second so once your trial balance gain site, cost trial to can done. then that simultaneously able is for timing we commercial of ready we see that maybe answer Does we'll with be a wise the commercial then the and academic part the can but do

Daniel Walker

at is do actually with at at feel a the the SPA, compared confident manufacturing the to does. manufacturing there's in at you between the mean, that guess they FDA do commercialization? I also SPA, level time the how resubmit of the because the so And because the trial this in I the to on difference obviously, only the critical ensure manufacturing, outcome. alignment, of there addition BLA, but time though, the you forward, was ensure moving not go That quite you around How manufacturing that

Chaim Lebovits

clarified even more. you helpful question very That's the you. Thank

but to we do critical. conversations we separately on discussions us is But agreed do to if yes, the team. have on some alignment. alignment to which them, to takes to FDA of and have most, I've same come the are as those the of the not the the many continuing FDA while with clinical from the team with do So previously, tests, are answer it And to qualification trial patients with have we CMC those that separate will said issues, CMC come longer us

Daniel Walker

you're just exosome the why and expand what And or Excellent. you just Can if might technology on you briefly very pharma comment could lastly, Stacy that. I is know that wondering interesting biotech? or then was on on I technology. capitalizing just be that working compelling and to

Chaim Lebovits

Yes.

You mentioned if Stacy? Stacy Stacy, I to need, I'll course. ask so to on. I'll that, talk add of And

Stacy Lindborg

different done this technology and be would think is, of have excitement of have some been of of is wide And Daniel, unmet preclinical penetrate for possible would open this great an in that again brings an our that treatment. move nanoscale what's very we we a be a administration course, platform, is there's able and diseases number of to particles diseases therefore different and that lot really a which and of array studies, there Sure. exciting technology of that which effective and need portfolio. additional can and as published, we've human But us options that these allows we explore cargo can that offers a and about parts interesting certainly developing to advantages. of interesting carry it into different thought exosomes part bodies

Operator

the to of appears our hand session. I end That be Chaim question-and-answer much. very to back comments. over will closing you now for Thank

Chaim Lebovits

wonderful much, Thank have you and a very you. Thank day.

Operator

conference. does This everybody. you, today's conclude Thank

day. a disconnect and you participation. this phone have for may time, your lines your You at wonderful Thank

Brainstorm Cell Therapeutics (BCLI) 14 Nov 232023 Q3 Earnings call transcript