BCLI - Earnings call transcript Q2 2024 | Brainstorm Cell Therapeutics Inc.

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Operator

Greetings, and welcome to the BrainStorm Cell Therapeutics Second Quarter 2024 Conference Call. [Operator Instructions] As a reminder, this call is being recorded. And I would now like to introduce your host for today's call, Michael Wood of LifeSci Advisors. Mr. Wood, you may begin.

Michael Wood

thank joining and today. everyone, morning, you us for Good

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

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

will Joining CEO Interim us Chief the be call Financial and Alla Chaim morning on Lebowitz, and Officer. Brainstorm President this of Patlis,

during on Hartoun session. Chief Q&A also will Dr. line the Dagher, answer the are Operating Hartounian, Officer, and questions addition, available Chief In Officer; Dr. Medical Bob be to

So Lebovitz. the I'd Please go over like now to turn ahead. call Mr. to

Chaim Lebovits

We're our in trial the interest us NurOwn and ALS. IIb and making everyone. BrainStorm. joining you your to Thank for continued afternoon We Thank Good in in Phase today. preparations progress substantial morning you, Mike. for for support appreciate

having now agreement is a FDA. Importantly, a SPA asset, NurOwn written derisked from the secured

year agency's advice. for we The in significant be the milestone, of earlier input continues need unmet and exists FDA their we and are underscores recognition grateful ALS. the that in the to which announced This supportive,

FDA, the the reached alignment the FDA aspects during to on second we with In addition trial. of CMC III quarter, Phase

in have very face-to-face certain participated Therefore, therapy during various is to initiating previously we their and products constructive a the June, outstanding C the meeting in that regulatory Type at important complexities FDA resolved process. In manufacturing additional a steps process, including involved it's CMC questions. trial. have Cell pivotal now prior

protocols. Our collaboration trial with the in key has instrumental advancing CRO been

We are diligently selected building network CRO have to geographic centers clinical diverse broad representation. access ensure leading and XX over of across a and patient a leading regions

track the a including are actively remain to processes the committed XXXX position, $XX We to secure of the trial manufacturing promising first for bolster potential application initiating Q grant The our to well financial XXXX. meet and believe on pursuing nondilutive with up To we're million. production I to timelines. by advanced, end of the funding,

treatment with families. is overstated. ALS be a potential The cannot their options. trial successful and impact significant devastating disease It represent for a patients of IIIb breakthrough a limited Phase could

our We and updates are committed progress. about regular transparent to providing communication

work. We of and continue community, important ALS we collaboration grateful entire are as support this the the for

the a notified days trading address XX in NASDAQ [ upcoming meeting. we statement, shareholder XX us by our and items has October for consecutive billing. a to want maintain proxy ] I price share must for $X that the risk

of with a Meeting. Annual challenges maximum Directors these Additionally, shareholder is NASDAQ simply Board, a if listing not split. to to comply becomes the key this provide earlier-than-usual reverse item to it reverse maintain approval to cap. if agenda the affect the Shareholders It To to approving the flexibility, we and grant the necessary necessary achieve address implement, an market [indiscernible] seeking understand Board we've authorize need does A automatically million scheduled our NASDAQ to listing. of $XX It's with deemed company that to important trigger the requirements. proposal discretion

The price including the protect a the transition all up shareholder possibilities maintain reverse we we'll carefully options good avoid our including value with and potential OTCQB, will without for compliance work split, believe to to consider to listing. reverse NASDAQ to exhaust we'll all reverse driving or a diligently to NASDAQ While news, Board the regain the this opt If available split essential split. we OTCQB. resorting have share option it's

goal to maximize is ultimate value. Our shareholder

shareholders. challenges and confident are to ability our We to delivered in these navigate value

improving make Your flexibility is have to proxy crucial the support to ensuring for best the company. in the the we decisions

continued your for support. you Alla? Thank

Alla Patlis

restricted approximately $X.XX million and June and cash as and XX, XXXX, $X.X million X XXXX and equivalents of XXXX. and June million General of approximately and X were June and million, $X $X.XX XX, XXXX, for Thank the expenses development the respectively. June XX, months Chaim. were for million, administrative million XX, you, expenses $X.X XXXX respectively. as ended $X.X XXXX, cash were months approximately to Cash, ended compared Research

the approximately ended for XX, was XXXX, the $X.X X loss and XX, the X ended and months months per $X.X of million, months XX, X June net ended The for $X.XX million share XXXX. XXXX, was a June to compared $X.XX, respectively. loss for Net XXXX as approximately June loss Net

to back close to I will the turn it Chaim call.

Chaim Lebovits

Please, call the Mike, forward questions. open much Alla. the the you written written with We'll can please go Thank so questions. you for now

Michael Wood

Yes.

you key First to elaborate question, that the forward milestones looking [indiscernible] Should near the on please term? can in be

Chaim Lebovits

Absolutely. Mike. you, Thank

near enthusiastic potential drive focused several are significant catalysts In are shareholders' that the on should key about milestones. value. We the term, we very

on ability step. This Firstly, securing our first to trial few the line a site trial is efficiently. agreement execute time the clinical crucial demonstrates

will are can deliver initiation of progress. significant we these execute strategic our first major and believe for in shareholders. story pursuing milestones substantial our on will enrolling funding milestones actively accelerate and that the the strengthen our We position Successful patient successfully financial And mark and value nondiluted and trial acquisition funds partnerships. significantly through time additional grants of development line. we're these Secondly, course,

Michael Wood

you. Thank

question. Next

to a the possibility is quarters? equity there With the shareholders $XXX that $XXX proposed would million, for shares several existing your is What significantly increase next diluted. from in the be raises million authorized plan over

Chaim Lebovits

for we you Very can question. so this this. good clarify Thank

the Of shares course, equate financing. the only to not authorized immediate with to does an strategic concern This opportunities we that provides emphasize to us important pursue potential regarding resorting diluted flexibility action What's dilution. dilution. increase understand to without in

primary sources, Our -- such collaborations funding collaborations. nondilutive grants is focus and other as strategic

authorized BCLI securing than of close We maximizing flexibility demonstrating have without The issuing decision XX-year track shares execute to XXX our have ensure to strategic the of ability demonstrates while our history This value. to funding, successful record strategy. efficient a raising the a shareholder on we capital future dilution. on unnecessary million. less long-term a management, growth $XXX shares, commitment capitalize to to is increase proposed in million has nondilutive opportunities

to We all to continue will optimize avenues capital explore and allocation dilution. minimize

Michael Wood

of currently you nonequity before grant's a sources property? outsourcing of of initiation the trial? And a Can what profitability related good Phase speak to intellectual have question, transacting the IIIb funding partnerships or potential

Chaim Lebovits

you. Thank

nonequity So funding actively pursuing revenues. we're multiple

property not technology grant is provide Phase our award grant example success. can both intellectual We stakeholders. Regenerative We're financial that of our for partnerships the table. of maintaining was for with pharmaceutical control on support from previous nondilutive a Institute essential long-term companies supported It that the advantages. currently core California CIRM, our other industry III These believe and was is and trial. Outsourcing Our million also strategic Medicine exploring efforts. $XX a good collaborations over

to However, we're mutually sharing the terms. technology licensing partnerships open strategic involve or on that beneficial

Michael Wood

signs of that The early allow take-to-peak planned a of clinical efficacy regarding provision next question interim would the trial, analysis reported? there or is

Chaim Lebovits

-- So you. thank

IIIb Phase to periodic are So will and monitor Monitoring for patient's evaluations design. members currently Thank an Board their Board responsible for But independent safety Data being the well-being. and Safety finalization. the trial DSMB established The under safety you. is charter be

Michael Wood

the study? higher prior ALSFRS-R than in is question Phase the Next enrollments III

Chaim Lebovits

Thanks Bob, please? to want you question, that take do

Ibrahim Dagher

conducted is to you. based Thank Yes. simulations, based trial. be total in And trial higher forward The the looking the Thanks, -- those to of score Chaim. execute previous on ALSFRS-R expected assumptions. properly the than we're on

Michael Wood

the the be [indiscernible] will more III, more sites And trial also trial, to in on the than Phase filled be thus there prior allowing trial quickly?

Chaim Lebovits

That's for you. too. Bob Thank

Ibrahim Dagher

Yes, than about Phase higher for add for thanks. number I'll in III a Phase question to that pipe a planning the in trial conducted of XXX roughly the well. patients of patients, take was Yes, same, are we it the IIIb as number trial.

and expect enrollment, this increase of trial. we'll the We speed timelines Thank the of the also rate that will you.

Michael Wood

And at has a down this being locked point? commercial partner manufacturing

Chaim Lebovits

Haro, please take that one.

Hartoun Hartounian

are Thank for question. manufacturing with you, We're trial for potential in manufacturing for simultaneously engaged and discussions advanced highly sites commercial Chaim, partners. planning qualified this multiple the

approved. secure commercial manner our details a ability is While specific to of a partner our confident until we the are and suitable signed, in product if when we cannot launch to a timely in contract support disclose

Michael Wood

pool IIIb III Phase more thus prior study, trial patients of the participants? or Is a ensuring you. Thank criteria the than healthier stringent Phase inclusion

Chaim Lebovits

do Bob, you take you, Thank want that? to

Ibrahim Dagher

an to course also the by well. treatment, disease. for but showing are as will patients earlier for likelihood criteria and Phase by we the data. in The the which disease being with be more Phase III, of believe designed having informed trial that enroll overall higher Yes, to that question of are the is Well, benefits strengthened we goal our refined the you. on Thank sure. robust they Thanks yes, a patients focus IIIb inclusion from

Chaim Lebovits

very Thank you much.

the for open any received. from additional I written line. questions investors Ali, the think questions we that any concludes on the you call would

Operator

Our question coming Maxim is first Group. Instructions] [Operator with McCarthy Jason from

Joanne Lee

is progress on this Lee made quarter. for This Jason the call McCarthy. Joanne on Congratulations the

CMC the the alignment, new with actions the on need the CMC front Just or any implement adjustments to reach company regarding alignment to FDA? does the

Chaim Lebovits

We But that able for very be much. important. was alignment initialize Thank trial, clarifying you you that question. very the reach to and thank to

Joanne Lee

us may a study, IIIb? if criteria? mechanistic ALSFRS might made identifiable a be easily [indiscernible] Got these And And just the rationale changes more for briefly how follow-up, ALSFRS you could impact could entry the of effect as criteria. you regarding new the And provide just adjustments remind it. the to upcoming under the upcoming Phase

Chaim Lebovits

question? to Thank you, you this want do Bob, take

Ibrahim Dagher

that. for your question. I'm happy to Sure. Thank you do

-- to previous of criteria the worst. So XX score, can be sure make X. regarding made scored that is X item X, the X, or Recall, being X a every that score items, the out basically, of are the the each item there X every number a is trial. on to from main #X, differences is item, ALSFRS the We from score

are we any of answer not items. the That's So #X. one XX on any X, each allowing X,

X ALS XX or allowing to #X, not from once we are you your symptom, total than is didn't that showing lower. allowance want years maximum. also either for by someone symptom But start first reason XX or in later first time -- points. be any typically XX, score or years the without X XX sorry, for XX -- of or is XX progression XX X The more to really X remain we of not you drop to XX.

So the allows or people at enter to trial the score XX less.

ALS. to to looking are of get we're as very criteria, at a And first slow also capacity sure time. looking we paired, get years basically with documented X which relatively making and symptom-onset, after in such quickly typical diagnosed the from symptom be looking #X, associated patients looking we XX%, evidence regulatory carefully be above that their with healthy entry at function to they get is the vital that

Phase conducted clinical together one We with stimulating puts total in is confidence a of us trials recent Combining [indiscernible] I And ALS a previous conducted than databases, higher criteria, score, and those was that on were those more database. a the the the all of entry in in large score line than that mentioned got III. what them years.

NurOwn, target population that's is that earlier we population the criteria for. with which high benefit I to these together this from So will most answers in question. your the disease the for get confidence have hope

Joanne Lee

was Yes, that helpful. very

further of the the forward study. updates Looking on to launch

Chaim Lebovits

call you. you so on for the much Thank being today. Thank

Operator

from coming Research. Zacks David Cap Small is with question Bautz next Our

David Bautz

So in XX-week III have Phase the looks open-label to regards it's trial, like double-blind XX-week to a extension. upcoming period going it a and

will the the the the immediately data for could potentially double-blind BLA? open-label BLA BLA, from results essentially to the that? be positive be required from filed Or extension portion, after in the So filing assuming regards

Chaim Lebovits

able be would we the first the BLA for the question. double-blinded period. No, Thank half to file after you of that

David Bautz

still comment Okay. advocacy just any sense And physicians the I was for neuron, their seeking how you've of enthusiasm or ask advocacy maybe funding for patients also if whether but even patient already I potentially commented Phase could and you about general the was on trial? about have would groups, funding, going grants patient III potentially or the groups wondering of to also type available

Chaim Lebovits

that Thank you very question. for much

that of you ways can trial. with are patient can I board, I diligently and than we working groups, in will We supportive that across are IIIb very previous and the tell Phase seeing also see this even grants. of we're you the publicly tell excitement advocacy advocacy But many -- more trial. patient Hopefully,

know, IIIb trial. a data answer, some in NurOwn, felt have again, an III, focusing that the Phase think as they're but didn't to on the the they the we that to is you As have we has Phase answer of them and very They population on, patient clear and of are again sufficient patient described supportive now the population show efficacy. that Bob best chance that want

So groups And from that the there are wasn't getting support. I far a of support different we're lot we getting think in past. Yes. stronger

more one Okay. question, Operator, please. time have we for

Operator

question We private who from a have Christopher Nicholson, a is investor.

Christopher James Nicholson

on give further you you at overall? give likely of on And if a are on cost this the the are point, Research a this I'm not of time. ACF the wondered color Equity of treatment able any any either as a private production cost course I'm follow-up, us Research. I of at or trial head to a at in basis investor. per position color to a Analyst each

Chaim Lebovits

this so you Thank for question. much

are So not in position still is that the now. a we answer

more We cost is the just manufacturing will that small the it's The the for geographies prices, trial. near the contracts share, with and finalizing for different that from course, not of a costs, main difference. phase in future will that in different the centers of that and of be cost reason still we're different of manufacturing the trial,

able therefore, So process it's prices it industry a and trial to for from period. be significantly time, also and months. longer to a $XX to but in give we'll the with this versus in because not stage you XXX we'll process, with what costs now about But years an million patients for X a cost, will implement time, this changing manual X few -- change we're not production and previous automatic product sorry. the maybe a a be to us later And able CDMOs the for is whole cost. the would provide and only definitely able And it's numbers months,

the are product We try to really focused down to cost. bring

cell on processes with as So doing are that. to you while at in huge same get R&D and trial, the focused this gene very It's important we for very well. we're initiating very But we're of this still, undertaking these working our hard thank time, cheaper very therapy, and much questions.

Christopher James Nicholson

around that technological is could going If it current I could it just other your the follow do your up slightly it and that that way reducing? are very the into Or that is well Is see play manufacturing on space? one. development they you you're somewhat expectation innovations on in the because innovative. experience therapy costs

Chaim Lebovits

Thank that you for very much question.

to dramatically are good can developments the get will So product, if many in be we get definitely But cheaper. automated can we we -- even manual the product, if having validated decreased. a price

per if of in than in we a the the may on you it. hopefully, even trial, price previously, think dramatic cheaper whole have -- product thing this look I

things exactly touching very So wearing in are working we next And this. different now on -- the we're out but -- that still quarters, very you you're Thank you those updates hard. see will much. on hopefully, on

the thank to on So for everyone I today. call being want again

be very X:XX have the thank continued just a.m. quarter for your in next next will finish and us, you joining We hopefully We what this quarter, additional everything speak very, in we time you in a for today. the even are much very we're initiating to to much. call. Thank in when all finishing you We and better Thank trial. the and looking we in a exciting discussed in very, to support, for place after updates we'll wanted line fall everyone place, hope

Operator

Thank conclude does you, call. and ladies today's This gentlemen. conference

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

Brainstorm Cell Therapeutics (BCLI) 14 Aug 242024 Q2 Earnings call transcript