Earnings call transcript Q1 2023

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Operator

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

As a reminder this call is being recorded.

I'd now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. begin. may you Wood,

Michael Wood

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

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

Forward-looking and to numerous no risks uncertainties, differ those today's Brainstorm's from are results and statements SEC The are which to time-to-time any call undertakes company's projected control, the statements. described uncertainties update from filings. and conference forward-looking may subject the many the beyond company's including company materially of in obligation on risks publicly

Officer. Brainstorm; Financial Joining the Chief Lindborg, Stacy Dr. Co-Chief of Lebovits, Chaim Patlis, Executive CEO Interim on us and and call this Mr. morning President Officer; Alla be

session. and Taylor your be answer In also addition, available the Company's call Q&A Chief during Dr. VP Executive will the questions is Officer, and on the Medical Kirk to

go call over ahead. turn that with Mr. to the So Lebovits. like to Please I'd

Chaim Lebovits

XXXX us our thank and you all of you, recent who QX have and Good to joined Thank results progress. to Michael. you discuss financial morning,

announce notified as there our we know We'll us The was it. recent be the committee advisory discuss for Brainstorm will BLA. date that to as the an development FDA that most important soon

investigators, most accessible and of appropriate program of the on our ADCOM the commitment clinical includes fastest It reviewers, full expertise, input point will obligations way and ALS experts, all company's and that patients. stakeholders that be FDA and to from who in publicly experience fulfill regulatory discussion community the a view. based confident remain their relevant holding conducted respective We to ensure will and

Brainstorm important and believes evidence predictive A show of approval support our analysis of NurOwn to encouraged data and further span consistent firmly to Phase effectiveness trial which data, we regulatory meaningful thorough biomarker and ALS. are the data the clinical of pathways strong are clinically by of X NurOwn. response

neuroprotection of Neuroinflammation, with allowing mechanism neurodegeneration, and NurOwn, actions.

I'll now highlight turn in This morning the of and myself Kirk Lindborg, room the to of Dr. Dr. NurOwn's we the to Taylor. a Stacy call detailed review be to support for the actions dataset Dr. and same fortunate with over our with sitting BLA. are Lindborg more

you, Thank Stacy.

Stacy Lindborg

Thank you, Chaim.

As the a be that Chaim of our patients just critical relates ALS the issues reasons an ADCOM remains discussed fulfilling need our highlighted, addressed. one to of towards scientific and to to commitment complex goal step

a deep from thoughtful assembled data and benefit set that have robust discussion. We will a

approval. The any package data evidence that the strong determined will for And to process generated. is by be enough this believe NurOwn's we approval BLA support primarily of firmly front, body on regulatory of

an open We provided are all with grateful to clinical stakeholders by opportunity body key the setting the ADCOM. evidence and FDA of transparent for to the review the full in

provide line trial X into analyses. valuable from These effect. have announced data NurOwn's treatment and have understand NurOwn's analyses additional the Since trial, a we the first helped we of insights number conducted top outcomes us focused Phase better

and statistical significance did secondary X the on trial Phase As disclosed previously, endpoints. reach primary the not

NurOwn on the compared pre-specified at to there meaningful endpoints with baseline, disease participants was treatment and a a However, clinically group less advanced placebo. response in secondary of with primary

level to difference On focus by endpoint, rating not by which in significant the and favored the to data the of impacted ALS the treatment baseline is at change as functional statistically P> week scale, XX X.XX. on FDA, These secondary us average effect subgroup the was this the from was enabled important the floor that as findings the are looking scale. pre-specified at

which sensitivity to This across ALS, on compared and represents Furthermore, secondary analyses with were people ones. clinically average of quality life their function who NurOwn post important function more those hoc points of placebo. to a baseline is showed loved preservation living as of participants result, the XX on thresholds meaningful for of on as X well retained that endpoint of same participants XX treated

demonstrated the hoc treatment effect post study important have scientific different and ways presented floor Additional similar analyses effect have meetings findings each across an NurOwn endpoints. which in with for and been at account

of these and Muscular Dystrophy with - Clinical presented a at of effect analyses these very of the All Association in Scientific year, fact, evidence recently one this conference baseline. focused floor participants at on no and

baseline participants on scale analyses they these was participants measurement scores analyses, baseline in ranging ability the the based to up through items is measure all And problem this issue. hits a XX decline than which the participants first from included more trial this rather half of of had feature the analyses trial This focusing XX. the defining than at The the for values. of the results from the baseline on ongoing scale in scale at heart and

endpoint, of XX response treatments rate On response a difference the p-value NurOwn analyses of XX% a XX% a and and observed with the primary we a X.XX. response between with rate clinical

average participants again week p-value of compared a to significant On XX, placebo secondary treated retained from X.XX. function baseline the with endpoint, average of to on X.X points change NurOwn

biomarker program in I'll on being and generated We our trial. identified in biomarker comment three and relates to biomarkers ever strong conducted pathology observations. largest important NurOwn's rigorously analyzed resulting them The evidence data piece ALS. our the to last X consistent has in of Phase distinction of that relevant the study CSF clinical ALS

placebo. these NurOwn significant have X. compared treated participants the target ALS. markers This treatment neurodegeneration increases NurOwn of we important achieved to and impacts NurOwn of and pathways, one, markers means of action Phase in in and with decreases in mechanism Number confirmed over three neuroprotection of Across to pathways engagement time neuroinflammation

have with those demonstrated to participants, biological NurOwn these advanced in challenges. ALS we where measurement with scale important all activity two, NurOwn ALS Number rating served ALS across including pathways the functional

treatment three, with placebo. outcomes following statistical with not data Number clinical CSF baseline baseline This X was Phase with and modeling NurOwn true predictive of in trial identified biomarkers for observed following treatment NurOwn. the using

data in rating most in sample trial, unable ongoing other products. decline safety approved and who to we clinical enrolled outcomes supports summary, the objectively walked was measure you functional a in data, ALS relative the Based efficacy data unique significantly evaluation that ALS in trial I've believe positive the participants were with NurOwn. So treated amassed with scale of the of a we better can that we of evidence advanced through, show benefit to NurOwn. that have demonstrate risk just and And participants on have participants biomarker we

in we the we efforts important Lastly, continue engage patient scientists community our process. the continue to through and advocacy with regulatory other with as neurologists,

at the the MDA the opportunity the quarter, Summit. at to and and ALS NurOwn on Research Clinical Meeting Scientific Annual, During I California Annual present first had

examples our upcoming ecosystem. Advisory are ALS, share dedicated of from we so requests in they with receive Meeting. organizations we present engage to can continue Committee doing I know also the we requesting that these our that to to different as data ALS prepare We you parts everything participate to

Now I'll turn Chaim the additional for back some to call comments.

Chaim Lebovits

Thank you, Stacy.

capability possible. broad at our data We ALS in advocacy which that in are access the months, in to to for access urgency approval successful build medical want anticipated and the be the we for wait teams We and NurOwn's quickly to through a and if our to Based therapies patients targeted growth. is regulatory preparation will needed. to be move began for expand clinical confidence NurOwn, short new able ALS as families on achieving gain and recently coming as so

VP medical efforts X President areas including On He's Dr. rare more role three through from as years appointed Phase played Vice Officer. has and Taylor, experience programs Chief from multiple instrumental approval an Kirk post therapeutic of drug May whereas he in joining Medical and XX American led neurology the global and launch senior North than Serono, treatments. new X, there of across EMD Affairs, and the development studies we Executive the of team in diseases. BrainStorm Medical Kirk

call and session. formally him welcome with pleased BrainStorm, medical relationships will the BrainStorm. take Kirk on opportunity affairs launches, including experience He's and us medical here the At the We're joining have to efforts product planned to today community. this global to want capabilities lead for Kirk's function commercialization launch post very with the activities I joining and team. to Q&A the deepening approval someone

I hires additional two highlight. also to are There want

as The Each and years the Regulatory is products, experience. for of first rare Vice Clinical global President of as recognized XX in oncology CNS, specialty of Antonio diseases. Operations. Global including approximately and appointment in recent Trejo Wallace the specifically is VP Affairs them expertise relevant Antonio regulatory of areas bring Robin

their excitement of drug, prospects. believe agencies in to they large across addition biotech clinical team Amgen, We our has NurOwn's the across to worked roles record companies will new leadership and know biologic in Canada, ahead. with Israel, has countries a having and as smaller these Merck regulatory to well with at operations Novartis, companies. expand track prepare the exciting excited and He U.S., both individuals device I'm the in continue for our programs, BrainStorm and demonstrated Latin Japan them as talented Robin including share around future America.

in companies is approved FDA hardened bring is of topic these the treatment less ALS. efforts [indiscernible] in both seven approval other the interest the April. to XXXX. be months, both other ALS one there's We're watching these ALS community. with the second the being the for drug of the new new the for FDA Finally, for We're regulatory treatments [Amolex] want by to accelerated that has treatments that sponsoring This shown briefly a cover to flexibility and the of of drug new developments by than granting and great applaud proving I of of obviously the products by space of to

I'll Alla our Alla? to financials. now turn the call discuss to

Alla Patlis

you, Chaim. Thank

million cash, you million $X financial bank XXXX. on results. It deposits is compares cash equivalents my our to pleasure XXXX. short-term December XX, and approximately now first to This XX, March walk through BrainStorm as of were quarter $X.X

development XX, million and expenditures Our respectively. and March $X.X approximately for XXXX three months were the and research XXXX million $X.X ended

XXXX net compared or General three loss $X.XX million and months XXXX, of March per $X.X and million XX, XX, for XX, loss or expenses was $X.X XXXX. ended were March $X.X March ended share as $X.XX Net share three million the X months to for months $X.X the per ended administrative and XXXX for approximately respectively, million. the

call. the close I'll turn to it back to Chaim

Chaim Lebovits

you, Thank Alla.

if please questions. call can on Michael, and then the the will give the and having line anyone Jenny additional operator, questions you for the Thank Q&A we And read open we - you answers, Michael. will read you, will after the open then

Michael Wood

Yes.

First a question the upcoming have committee? is, firm date do for you advisory

Chaim Lebovits

share a will once No, we we will date. that have we don't with have, you. yet And firm

Michael Wood

thanks. Okay,

question the study? to X Phase Next study, inability BrainStorm the unless ALS participants their advanced the design regarding allow did the during to why measure with X Phase progress

Chaim Lebovits

Stacy?

Stacy Lindborg

on question reflected we've Yes, this internally.

our addition rating conceived clinicians in FDA esteemed effect in is study our that functional industry And the trial. of III level well associated at for XXXX to with understood who not the was design time. floor the R&D the reality the and were was as being The part PIs by ALS XXXX. scale with the In submitted was Phase

in advanced looked addressing days decline functional scale, a most measure specifically first early any explicitly. disease. database understanding we articles could following was find document the we when with with slot ALS able the this we were rating in not the the fact, the in hardly scale the to In literature participants When to even it that phenomena

enough estimates. that found that But end advanced confounded an the the of referenced floor insensitivity the of ALS at ever no treatment had lower articles a such one had sample scale. We large with participants

level We know established. case. the no the is So this longer wasn't

this taking to analyses trials into minimize their fact, to trial include And are even designed ongoing floor analyses plans being effect. account. In is every the today amending

R&D, ability steps and In to when not need know understood. a the learn. it's in not as the constantly through unusual faint you a we the of well something for It's new biotech it learn requires you to are heart to trial go do industry, and

them share First, you as analyses out openly. and to carry need described all originally

the guess Second, in our be fact for not that trial that in you And you the I analyses blessing. produce observed very sense, learning, some each of as these a and anticipated. can define what third, what observed. appropriately was And objectively We've was displayed our was done address measured steps. that learning

we day, measurement believe what NurOwn and of evaluation problem, risk end facing evidence scale bring that positive is of a of address approval. the which forward benefit we are a the At we warrants can

Chaim Lebovits

Thank you so Michael? much.

Michael Wood

BrainStorm the related ADCOM. biomarker question, Next it been challenges analyses that's biomarker long must the in have And talking at be have again does published a the successful that time is order published? question, believe been a you've a to what for about manuscript now, there new

Chaim Lebovits

Stacy. you, Thank

Stacy Lindborg

submitted. we in for Do of the we that published, informed a believe the perspective, successful community speak then necessary. no, the the more we will the it and publish, we think ADCOM needs believe this be data But to in status From more manuscript is to a review don't will be the be authors be. final we is do hands as all it

you that in and rigorous the ALS that be control. it's tell a it we're of is generated But obviously through optimistic with valuable can therapies development into of in this I will out aid advance paper our ADCOM. is of insights will we've pathology What future which the published

Chaim Lebovits

you. Thank

Michael Wood

accelerate to you company Our with large biopharmaceutical other for indications? for to ALS willing and a trials partner clinical next question, are cap

Chaim Lebovits

in Well, treatments to patients ability need and of company that development always our accelerate to willing of are we're entertain partnerships of best the interest further sure. the in

Michael Wood

Chief This perspective Dr. the have Officer. share what pleased Thanks. some exactly hiring, BrainStorm? motivated question I was on join you is more said, Kirk one can release Kirk, read actually he to announcing it Kirk's for as Taylor. press to you investor Medical

Kirk Taylor

Thank Stacy join onto medical you, unmet that We're Thank treatment and Also, I'm honored new the researchers to need Yes, assembled. professionals BrainStorm. community bringing a the ALS join it. Michael. possibility key were and the Appreciate for great and world-class you. biotech of to team to Chaim motivators things. the of have me

Michael Wood

Thanks the concludes Kirk, questions. that inbound

Chaim Lebovits

on so they you and questions also Thank Michael. how participants Jenny, call for you advise ask? can would much, open the call the

Operator

No Thank Chaim. Instructions] [Operator problem, you.

line Your of your first question coming David is Bautz from live. David, is Small-Cap. Zacks

David Bautz

everybody. Hi, good morning,

Chaim Lebovits

Good morning.

David Bautz

actually on Quickly is when data, times FDA the much when to between the and usually how it ADCOM occurs? be going the does lead give announcing and potential meeting the

Chaim Lebovits

to for David, us this, it's bit this very a good due call little Many to only. this from into offline, question. I more not asking like a in And this. actually this dive opportunity are

it obviously. give will not has And ADCOM FDA the So this a to priority be yet that to a before right know we date, the until be between don't PDUFA - has or this priority review. review

- that are in the the We tell can that you dates. when understand may working is somewhere with on through date, do process actively discussing we be us I it FDA they ADCOM middle. that went the

once just we're that, It's final happening. it's we announce that. have we'll date waiting have and to So the confirmative

the So clear. you tell in quite I can to months. going it's be next It's few

David Bautz

Okay.

the say there's the ADCOM, can the testify? at an definitely gets anyone of Now Does, control I over that who and meeting? to hearing at public have always portion company speak where come open essentially any

Chaim Lebovits

right no. to usually and speak. meeting for a Well, has that register Everyone

David Bautz

Okay.

Chaim Lebovits

that, I'm sure you're David. familiar with

David Bautz

Okay. company And other jurisdictions? is U.S.? clinical in going you the trial to And do advancing for be lastly, necessary get that think is to strategy what approval NurOwn the outside another

Chaim Lebovits

later on we'll an really also we Well, and a we heard an, time. with the in we other to be strong to here. of that in we're going confirmatory be you here. able as time approval lot as well. trial very probably, clear, with Antonio come We add can and We're focused a that but Committee discuss as working a but he's jurisdictions. anticipate the on is at Advisory now the getting team very He have look now to Meeting experience, all as Albeit on

David Bautz

questions. Okay sounds good. my Thanks for taking

Chaim Lebovits

Thank you much, David. so

Operator

you. Thank

a Your is from line is private Dan, next coming question your who Dan is investor. live. Michael,

Unidentified Analyst

by Can you of out million should cash $X.X with your March? now? end be finances the only You of money address at of left about

Chaim Lebovits

are we not. Well,

give can we through institutional a also use able We you waiting deals, support. just We we to us to will We're, the prices. look for had some opportunity in December, an and end similar number. were use they ATM don't if the at block ATM. these the where investors of Just bring want at

We waiting we're $XXX use And have facility being… Leerink. how J the and that just Ray to with million time opportunistically -

Unidentified Analyst

using you're moment debt? the At

Chaim Lebovits

use we No, in through institutional didn't debt. We blocks had coming the a and did ATM - do we share. block

Unidentified Analyst

you. Okay. Thank

Chaim Lebovits

books. Yes, no we Thank have you, convertible, debt zero debt, on our no sure.

Operator

appear [Operator any I'm We to… very Okay. more over questions. to Instructions] don't going have hand much. to you back Thank

Chaim Lebovits

second, Maybe Jenny - more wait one maybe

Operator

problem. No

live. investor. in your a is from is question We Richard, Robbins, Richard private he line a have

Unidentified Analyst

morning. the next press But realized release is generation on you're indicated ADCOM. working on that Good that your that? this please I the drugs. you Could in morning, expand focus you upcoming on

Chaim Lebovits

so working on research are team products different Definitely, development diseases. and different and on our

pipeline for for other ALS all an As even as you know, we a other we product, diseases working of are have Huntington's on diseases. access which same the have outside time, well. At MS, for Parkinson's, and NurOwn

once We have working a will on that, huge course of team have R&D we we that. announce but

Unidentified Analyst

you. Thank

Chaim Lebovits

welcome. very You're

Operator

Thank much. [Operator the Instructions] you Chaim. It join to queue anybody don't very appear else have

Chaim Lebovits

this for you much, Thank problem. with morning. call. us for this Thanks everyone very No Jenny, being

you are very next the very for and for Q ADCOM with you the much. we'll see good fired We you hopefully, on geared and news guys. up Thank

Operator

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

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

Brainstorm Cell Therapeutics (BCLI) 15 May 232023 Q1 Earnings call transcript