Brainstorm Cell Therapeutics Inc (BCLI) ニュース

BCLI under $3

BCLI, new 52/low

BCLI 1.30 + 10% Israeli company low floater decent news.. NEW YORK, Nov. 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it has entered into a Memorandum of Understanding (MOU) with Pluri Inc. (NASDAQ: PLUR) through its wholly owned subsidiary ("Pluri"), an established global leader in the development and manufacturing of cell-based therapeutics, to manufacture NurOwn® for use in BrainStorm's planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This MOU enables BrainStorm to begin transfer of its manufacturing technology and start producing NurOwn at Pluri's manufacturing facility upon finalizing the binding definitive agreement.

BCLI, new 52 week low

BCLI under $3

BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS

Up 12.14% today and another 26.0274% in after hours training. Something's happening. Maybe someone leaked positive info about the Phase 3b trial.

Great day today! Up 31.03%. Hope to see a lot more of this.

what going on today? no news show on Fidelity.

Top line results on 29th,still very little buying,lots of darkpool that looked like buying today and aftermarket,watching closely for actual buying with accumulation

chased and got killed here.. my fault.. too impulsive.

Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.
The process is long, i do not forsee results before mid 2025 earliest.
Myself i am long ago out, and only following the company for academic reasons.

Hopefully, they will set higher ALSFRS-R scores in the new study for the trial subjects so there will not be a floor effect again. Also, in a perfect world where everything goes our way, how long do you think this new study will take before we see the results?

Dear Shareholders,

We remain steadfast in our commitment to advancing NurOwn as a promising treatment for ALS patients. Recognizing the challenges faced in our recent BLA submission, we are ambitiously pursuing a Phase 3b trial, aligning with our dedication to the ALS community and our goal of making NurOwn commercially available. Despite the setbacks with the ADCOM's unfavorable vote, our focus remains to align with the FDA on a phase 3b trial design, as we acknowledge that this represents the most expedient pathway to approval.

We are exploring various strategies to secure the necessary funding. We intend to seek a Special Protocol Assessment (SPA), which, when agreed with the FDA, could significantly de-risk the regulatory aspects of the NurOwn program. We are very encouraged by the FDA's ongoing engagement, including the opportunity provided by the expedited in-person Type A meeting on December 6, a rare occurrence in today's regulatory environment. We appreciate the Agency's feedback, comments and other regulatory accommodations, signaling its recognition for the unmet need in ALS and its willingness to reach alignment with Brainstorm on our new clinical strategy.

Our team is diligently preparing to submit a clinical protocol, and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.

We believe that agreement on an SPA would open a broad spectrum of financing options for the trial. Concurrently, we are committed to maintaining our NASDAQ listing status. Our strategy focuses on enhancing the value of our assets, thereby garnering market support that is crucial for our stock price to reach its requisite level by April. We prefer this approach over a reverse stock split, as it aligns more closely with our long-term goals and shareholder interests.

We thank you for your continued support. Your faith in our mission fuels our determination to overcome the recent challenges and ultimately deliver groundbreaking treatments that will help patients in need and create value for our stakeholders.

Sincerely,

Chaim Lebovits
President and CEO
BrainStorm Cell Therapeutics Inc

BRAINSTORM CELL THERAPEUTICS INC.
Annual Meeting of Stockholders

https://east.virtualshareholdermeeting.com/vsm/web?pvskey=BCLI2023AM

BRAINSTORM CELL THERAPEUTICS INC. is hosting a Virtual Stockholder Meeting on Monday, December 18, 2023 at 10:00 AM, Eastern Time, and the stockholders of record will be able to vote and ask questions online during the meeting. If you would like to attend the virtual meeting and have your control number, please log in 15 minutes prior to the start of the meeting.

To the Stockholders of Brainstorm Cell Therapeutics Inc.:
Notice is hereby given that the December 2023 Annual Meeting of Stockholders (the “Meeting”) of
Brainstorm Cell Therapeutics Inc. (the “Company”) will be held on December 18, 2023 at 10:00 a.m.,
Eastern time, virtually via the internet at central.virtualshareholderm..., for the
following purposes

BRAINSTORM CELL THERAPEUTICS INC.'s Virtual Shareholder's Meeting - Pre meeting message page
https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=317853002&type=PDF&symbol=BCLI&cdn=149521fc0e34b68e67d975b2a1a58943&companyName=Brainstorm+Cell+Therapeutics+Inc.&formType=DEF+14A&dateFiled=2023-11-08

3,773,000 shares short!!! Time to cover?

Law firms short,posting ads like crazy before big day,being sued for poorly written disclosure warnings on prs,pffft

Patience,death hour over in 10min

Saying “E-X-C-E-L-L-E-N-T”in my best mad scientist voice,while drumming my fingers together.31s filled,now bidding .30s and .28s (doesn’t look like those will fill,bounced off the dma50 on 10min,also the previous run ceiling.29 on the 30th)

Some selling expected first 30min,ppl out of day trades yesterday profit taking today or thinking they can flip

Tomorrow is the big day,Christmas is tomorrow

BCLI ON THE MOVE

#BCLI 🔥 50% gain opportunity for gap up! See chart! $BCLI

Sold

Dec 6th FDA meeting coming quick here... Loaded up here...

Load them up boys... Dec 6th FDA meeting..$BCLI

BCLI, Big catalyst coming: it will have a meeting with FDA on Dec 6 for its Phase 3 trial. It was $3.2 in June.

Load

Getting noticed more I’d grab some or miss out

Dec 6 meeting with the FDA. Thinking the deck is stacked against this making it to market without a more robust clinical trial.

Still, looked like this could see a short pop.

Thanks brother

Shares available to short dropped 50% today,could see ZERO BORROW soon and huge run usually follows,I am in,just waiting now,chart looks great and lots of run room,potential is good,risk is low. Good skill to you!!

Hope so been adding to make the chart look good

4M+ short,squeeze could be huge

Still rising

Still collapsing shorts getting paid $$

Good News: $BCLI Published US Patent App #20230310507 Today For "METHODS AND COMPOSITIONS FOR TREATING LUNG CONDITIONS
https://image-ppubs.uspto.gov/dirsearch-public/print/downloadPdf/20230310507

$BCLI Currently 0.18 strong buy
Dropped from $1.80 last week due to FDA Committee voting that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.
Company's CEO said: "The people of BrainStorm will do everything in our power to fulfill the obligation we deeply feel we owe to the ALS community, and in the coming weeks we will explore all options available to us."

https://finance.yahoo.com/news/brainstorm-cell-therapeutics-provides-fda-024800252.html

No big difference. Dead money.

A great pity!

Kinda amazed that the stock price only plummeted to 19¢. I was expecting around 5¢ to zero range.

I want to be positive but I'm having trouble seeing a possible path out of this mess. Michelle Lorenz from the No More Excuses ALS Facebook page is already planning to flood the offices of every senator and representative with phone calls to somehow convince them to get the FDA to vote for Nurown in the official PDUFA vote in December. But even if by some miracle that happens, where is Brainstorm going to get the money to stay afloat and fund a new 100+ million dollar trial?

I doubt that they can dilute their shares more since the stock price is down to 19¢ and I don't think that a bank in today's economic environment will give them a 9-digit loan. What plausible options does Brainstorm have?

Re opened…

Curtains down as was expected. Poor ALS families,
hopes shattered!
Miracles have indeed occured in this part of the world,
however it occurred many many years ago.
Zero chance of FDA approval in spite of the ALS lobby!

Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed."
A lame excuse, BCLI had plenty of time.

BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS

https://finance.yahoo.com/news/brainstorm-cell-therapeutics-provides-fda-024800252.html

NEW YORK, Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn®, an investigational mesenchymal stem cell therapy for the treatment of amyotrophic lateral sclerosis (ALS).

Today the Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.

"The Committee's vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease," said Stacy Lindborg, PhD, co-CEO of BrainStorm. "We firmly believe that the totality of data presented for NurOwn today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response. We truly did our best to make the NurOwn data clear to the FDA Advisory Committee. Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed."

Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added: "The discussion in today's Advisory Committee meeting, and the heartrending testimony of those living with ALS and their loved ones, underscores not only the need for regulatory flexibility but also for continuing research in the field. The people of BrainStorm will do everything in our power to fulfill the obligation we deeply feel we owe to the ALS community, and in the coming weeks we will explore all options available to us."

About NurOwn®
The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS, which is under FDA review. BrainStorm's long-term commitment to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.

The Phase 3 pivotal trial of NurOwn did not reach statistical significance on the primary or secondary endpoints, likely due to a "floor effect," which confounds measurement of disease progression in patients with more advanced disease. A thorough analysis of NurOwn Phase 3 data shows evidence of clinically meaningful effectiveness in ALS participants who have not progressed to advanced levels of disease progression. In a pre-specified group of participants with an ALSFRS-R score ³35, there was a larger treatment effect across all endpoints with NurOwn compared to placebo, which aligned with historical trials and the study power assumptions and resulted in a statistically significant difference on a key endpoint (change from baseline in ALSFRS-R). Additionally, a post-hoc sensitivity analysis of patients across threshold of >26 through =35 on the ALSFRS-R highlighted that NurOwn-treated patients retain, on average, two points of function more compared to placebo–clinically meaningful preservation and important for quality of life for a person living with ALS and their loved ones.

NurOwn's clinical program also included most robust cerebrospinal fluid (CSF) biomarker study ever done in ALS, strong and consistent biomarker data, which are predictive of clinical response in the trial, span pathways that are important to ALS (neuroinflammation, neurodegeneration, neuroprotection), and align with NurOwn's mechanism of action. Biomarker data in all trial participants showed consistent biological patterns of NurOwn reducing markers of inflammation and neurodegeneration and increasing neuroprotective markers relative to placebo. Biomarker patterns were consistent across all NurOwn-participants, including in those with Advanced ALS disease where clinical scales, such as the ALS Functional Rating Scale, have demonstrated measurement challenges. Three CSF biomarkers were predictive of clinical outcomes in NurOwn-treated participants–NfL, galectin-1, latency associated peptide of TGF-beta1 (LAP or TGF-b).

The NurOwn clinical program has generated valuable insights into the pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted but never before explored in depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic analysis of clinical outcome, offering great promise for the development of future treatments for ALS.

BrainStorm previously announced the FDA's intention to hold an ADCOM meeting to review NurOwn for the treatment of ALS. BrainStorm filed a BLA for NurOwn on September 9, 2022, and received a Refusal to File (RTF) letter from FDA on November 8, 2022. Following a Type A meeting and subsequent discussions with the FDA BrainStorm requested that CBER utilize the FDA's "File Over Protest" procedure, which offers the shortest amount of time to complete the regulatory process. The BLA was filed over protest, allowing completion of the regulatory process in the shortest time possible, and active review resumed on February 7, 2023.

About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Notice Regarding Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding the upcoming ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn, the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital,

BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

Investor Relations:
John Mullaly
LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com

Media:
Lisa Guiterman
Phone: +1 202-330-3431
lisa.guiterman@gmail.com

Cision
Cision
View original content:https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-provides-update-on-fda-advisory-committee-meeting-to-review-nurown-for-the-treatment-of-als-301941169.html

SOURCE BrainStorm Cell Therapeutics Inc.

"The Committee's vote was a sad outcome for the ALS community, who have too few options to help manage this merciless and deadly disease," said Stacy Lindborg, PhD, co-CEO of BrainStorm. "We firmly believe that the totality of data presented for NurOwn today provide a compelling case for approval, with clinical evidence in those with less advanced disease supported by strong and consistent biomarker data that are predictive of clinical response. We truly did our best to make the NurOwn data clear to the FDA Advisory Committee. Unfortunately, had more time and opportunity been allowed, many remaining questions posed by Advisory Committee members could have been sufficiently addressed."

Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added: "The discussion in today's Advisory Committee meeting, and the heartrending testimony of those living with ALS and their loved ones, underscores not only the need for regulatory flexibility but also for continuing research in the field. The people of BrainStorm will do everything in our power to fulfill the obligation we deeply feel we owe to the ALS community, and in the coming weeks we will explore all options available to us."

With the level of open hostility by the FDA that was reported during some of the reports from the Livestream on another board, I think you would be wasting your time holding out any hope for the FDA.

I think their best hope is to try and get approval somewhere else, like Israel, or try to sell to someone that can competently develop this therapy.

The biggest loser in all of this are those with ALS.

Murocman

1 YES - 17 NO - 1 ABSTAIN

So, I assume this is officially the end but should we still wait for the PDUFA for some sort of miracle?

Market price reflects a 10%
positive news at most.

BrainStorm Cell Therapeutics Stock Trading Halted Today

https://finance.yahoo.com/news/brainstorm-cell-therapeutics-stock-trading-110000718.html

FDA advisory committee (ADCOM) meeting to review NurOwn® for ALS

NEW YORK, Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that Nasdaq has halted trading of the Company's common stock.

The U.S. Food and Drug Administration's (FDA) Cellular, Tissue and Gene Therapies Advisory Committee is meeting today to review BrainStorm's Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). The ADCOM meeting is scheduled to take place 10:00 am to 6:00 pm ET.

The FDA has posted briefing materials, agendas and webcast information for the meeting that can be accessed on the Agency's website here. The online web conference meeting can be viewed through this link.

BrainStorm's BLA for NurOwn® has a Prescription Drug User Fee Act (PDUFA) action date targeted to occur by December 8, 2023.