BCLI Brainstorm Cell Therapeutics Inc.

3.74
+0.31  (+9%)
Previous Close 3.43
Open 3.37
52 Week Low 2.75
52 Week High 8.14
Market Cap $135,679,544
Shares 36,277,953
Float 31,443,227
Enterprise Value $102,125,378
Volume 756,572
Av. Daily Volume 156,454
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Drug Pipeline

Drug Stage Notes
NurOwn
Progressive Multiple Sclerosis
Phase 2
Phase 2
Phase 2 top-line data released March 24, 2021 - safety primary endpoint met.
NurOwn
Amytrophic lateral sclerosis (ALS)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - November 17, 2020.
NurOwn
Prodromal to mild Alzheimer's disease
Phase 2
Phase 2
Phase 2 trial planned.

Latest News

  1. NEW YORK, Nov. 15, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced financial results for the quarter ended September 30, 2021, and provided a corporate update.

    BrainStorm Logo

    "We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important neural biomarkers…

    NEW YORK, Nov. 15, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced financial results for the quarter ended September 30, 2021, and provided a corporate update.

    BrainStorm Logo

    "We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important neural biomarkers that could be used to predict treatment outcomes within the trial. The insights we have gained from these discussions have generated strong momentum in our pursuit of the best and most expeditious path forward to bring NurOwn to patients. We also strengthened our leadership team and increased our manufacturing capacity, supporting our readiness to provide broad patient access as we seek paths for potential regulatory approval. The devastating and progressive nature of ALS creates an urgent unmet need for patients, and one that we are fully committed to addressing through NurOwn's continued advancement."

    Third Quarter 2021 and Subsequent Corporate Highlights

    • Presented important new Phase 3 ALS Biomarker data showing significant NurOwn-driven changes across a range of neural biomarkers, and that treatment response in the trial can be predicted using biomarker data and an innovative statistical model at the 2021 Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) conference. This data furthers our understanding of NurOwn's mechanism of action in ALS and provides additional evidence linking the mechanism of action to NurOwn's impact on ALS disease progression. Data were presented by Dr. James Berry, MD, Director of the Mass General Hospital (MGH) multidisciplinary ALS clinic and Principal Investigator in the NurOwn ALS Phase 3 trial.
    • Presented Phase 2 clinical trial data of NurOwn in progressive multiple sclerosis (MS) showing safety, preliminary evidence of efficacy, a reduction in neuroinflammatory biomarkers in the cerebrospinal fluid (CSF), and an increase in neuroprotective biomarkers in the CSF in an oral presentation at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Data were presented by Dr. Jeffrey Cohen, MD, Director of Experimental Therapeutics at the Cleveland Clinic Mellen Center for MS and Principal Investigator in the NurOwn MS phase 2 trial.
    • Highlighted the expansion of BrainStorm's technology portfolio to include autologous and allogeneic product candidates covering multiple neurological diseases at the 2021 Cell & Gene Meeting on the Mesa.
    • Presented positive preclinical results suggesting that intrathecal administration of small extracellular vesicles (sEVs) isolated from MSCs which were induced to secrete increased levels of regenerative and immunoregulatory factors based on the NurOwn technology platform may have clinical potential as a therapy for acute lung related pathologies (ARDS) at the NYSCF 2021 VIRTUAL Meeting.
    • Appointed Sidney A. Spector, MD, PhD, as Senior VP, Global Strategy and Medical Affairs and Kim Thacker, MD, as Senior VP, Medical Affairs and Clinical Innovation.

            o    Drs. Spector and Thacker will work together to create a formal global Medical Affairs function as the Company prepares for anticipated growth.
    • Expanded the responsibilities of Stacy Lindborg, PhD, Executive Vice President, named to the new position of Chief Development Officer.
    • Appointed Menghis Bairu, MD, to the Company's Board of Directors.
    • Increased commercial manufacturing capacity with the receipt of Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center ("Sourasky Hospital") in Tel Aviv, Israel.

    Financial Results for the Three Months Ended September 30, 2021

    Cash, cash equivalents, and short-term bank deposits were approximately $28 million as of September 30, 2021, compared to approximately $35 million on June 30, 2021.

    Research and development expenses, for the three months ended September 30, 2021 and 2020 were approximately $3.6 million and $4.1 million, respectively.

    General and administrative expenses for the three months ended September 30, 2021 and 2020 were approximately $1.7 million and $2.6 million, respectively.

    Net loss for the three months ended September 30, 2021 was approximately $5.3 million, as compared to a net loss of approximately $4.5 million for the three months ended September 30, 2020.

    Net loss per share for the three months ended September 30, 2021 and 2020 was $0.15 and $0.14, respectively.

    Conference Call and Webcast

    Monday, November 15, 2021, at 8:00 a.m. Eastern Time

    From the U.S.:             

    888-506-0062      

    International: 

    973-528-0011 

    Entry Code:                

    837509

    Webcast URL:  https://www.webcaster4.com/Webcast/Page/2354/43351  

     

    Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

    From the U.S.:           

    877-481-4010  

    International: 

    919-882-2331 

    Replay Passcode: 

    43351

    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 produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

    About BrainStorm Cell Therapeutics Inc.

    BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company 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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

    For more information, visit the company's website at www.brainstorm-cell.com.

    Safe-Harbor Statement 

    Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; 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:

    Contacts

    Investor Relations:

    John Mullaly

    LifeSci Advisors, LLC

    Phone: +1 617-429-3548 

    Media:

    Mariesa Kemble  

     

    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

    (Except share data)























    September 30, 



    December 31, 





    2021



    2020







    U.S. $ in thousands

    ASSETS



























    Current Assets:













    Cash and cash equivalents



    $

    25,695



    $

    37,829

    Short-term deposit (Note 4)





    2,114





    4,107

    Other accounts receivable





    85





    304

    Prepaid expenses and other current assets (Note 5)





    50





    1,002

    Total current assets





    27,944





    43,242















    Long-Term Assets:













    Prepaid expenses and other long-term assets





    32





    26

    Operating lease right of use asset (Note 6)





    5,338





    6,872

    Property and Equipment, Net





    1,224





    1,119

    Total Long-Term Assets





    6,594





    8,017















    Total assets



    $

    34,538



    $

    51,259















    LIABILITIES AND STOCKHOLDERS' EQUITY



























    Current Liabilities:













    Accounts payable



    $

    2,739



    $

    5,417

    Accrued expenses





    387





    1,261

    Operating lease liability (Note 6)





    1,735





    2,655

    Other accounts payable





    985





    1,900

    Total current liabilities





    5,846





    11,233















    Long-Term Liabilities:













    Operating lease liability (Note 6)





    3,766





    4,562

    Total long-term liabilities





    3,766





    4,562















    Total liabilities



    $

    9,612



    $

    15,795















    Stockholders' Equity:













    Stock capital: (Note 7)





    12





    12

    Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2021

    and December 31, 2020 respectively; Issued and outstanding: 36,277,953 and 35,159,977 shares at

    September 30, 2021 and December 31, 2020 respectively.













    Additional paid-in-capital





    192,384





    184,655

    Treasury stocks





    (116)





    (116)

    Accumulated deficit





    (167,354)





    (149,087)

    Total stockholders' equity





    24,926





    35,464















    Total liabilities and stockholders' equity



    $

    34,538



    $

    51,259

     

     

    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)

    U.S. dollars in thousands

    (Except share data)

































    Nine months ended



    Three months ended





    September 30, 



    September 30, 





    2021



    2020



    2021



    2020







    Unaudited



    Unaudited

    Operating expenses:













































































    Research and development, net (Note 8)



    $

    11,558



    $

    13,509



    $

    3,618



    $

    1,867

    General and administrative





    6,769





    6,684





    1,659





    2,618



























    Operating loss





    (18,327)





    (20,193)





    (5,277)





    (4,485)



























    Financial expenses (income), net





    (60)





    (197)





    59





    3



























    Net loss



    $

    (18,267)



    $

    (19,996)



    $

    (5,336)



    $

    (4,488)



























    Basic and diluted net loss per share from continuing operations



    $

    (0.51)



    $

    (0.70)



    $

    (0.15)



    $

    (0.14)



























    Weighted average number of shares outstanding used

    in computing basic and diluted net loss per share





    36,140,130





    28,695,540





    36,304,878





    31,154,101

     

     

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    SOURCE Brainstorm Cell Therapeutics Inc

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  2. NEW YORK, Nov. 8, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced executive appointments as the company prepares for future growth. Sidney A. Spector, MD, PhD, was named Senior Vice President Global Strategy and Medical Affairs and Kim Thacker, MD, was named Senior Vice President, Medical Affairs and Clinical Innovation. BrainStorm also has expanded the responsibilities of Stacy Lindborg, PhD, Executive Vice President, appointing her to the new position of Chief Development Officer.

    These appointments mark an investment in accelerating BrainStorm's progress. Reporting to Ralph Kern, MD, MHSc, President and Chief Medical Officer, Dr. Spector and Dr. Thacker will work together to create a formal global Medical Affairs function as the company prepares for anticipated growth. As Chief Development Officer, Dr. Lindborg will build a leadership team required for development and regulatory affairs to support clinical development in multiple disease areas and technologies. She continues to report to Chaim Lebovits, Chief Executive Officer of BrainStorm.

    "We are at a pivotal juncture in the history of BrainStorm Cell Therapeutics," said Mr. Lebovits. "Sid and Kim bring a rich combination of scientific expertise and experience that will be invaluable as we seek potential paths for regulatory approval of NurOwn® and advance our development portfolio of innovative treatments, as we continue to add new leaders with capabilities to complement our already strong team."

    Dr. Spector, a physician and scientist with extensive experience in the development of innovative medicines, is Clinical Associate Professor of Neurology at the University of Arizona College of Medicine. Prior to BrainStorm, he was Vice President of U.S. Medical Affairs at AveXis prior to the company's acquisition by Novartis, and remained at Novartis as medical director of clinical development, regulatory submission and launch of Zolgenzma, a gene replacement therapy for spinal muscular atrophy. Dr. Spector was also clinical lead responsible for management of Asia/Pacific clinical development and regulatory submissions in Japan.. Earlier in his career, he held senior roles in CNS drug development at Elan Pharmaceuticals and Pfizer Inc. Dr. Spector earned his medical degree at the University of Tel Aviv Sackler School of Medicine, and his PhD in Kinesiological Sciences at the University of California, Los Angeles. He completed post-doctoral fellowships at the National Institutes of Health, NINCDS in Neuromuscular Diseases and Neurokinesiology. 

    Dr. Spector stated: "I've committed my career to developing medicines that have a meaningful impact on patients' lives. I am impressed by BrainStorm's development of such important, potentially best-in-class autologous cellular therapeutics for the treatment of highly debilitating neurodegenerative diseases."

    Dr. Thacker is a neurologist, executive and patient advocate with more than twenty years of experience in pharma and biotech. Prior to joining BrainStorm, she was Vice President, Medical Affairs at Urogen Pharma. She also held senior roles at Mesoblast, Forest Research Institute, Sanofi Aventis, Pfizer and Roche Laboratories. She has a successful track record in innovation to support the advancement of human health, particularly related to eldercare and neuroscience and making a meaningful difference in healthcare. She has expertise in clinical development and launches, health economics and outcomes research, neuroethics and neurotechnology and compliance, including multiple publications and 12 product launches. Dr. Thacker earned her medical degree at the State University of New York Health Science Center at Brooklyn. She served an internship in Internal Medicine at Danbury Hospital and residency in Adult Neurology at Long Island Jewish Medical Center, becoming Chief Resident. She also has received training in Bioethics at Columbia University. Dr. Thacker is a Fellow of the New York Academy of Medicine.

    Dr. Thacker commented: "I am excited to join BrainStorm's leadership team during such a transformational period for the Company. BrainStorm's unique approaches to the treatment of ALS, MS and other highly debilitating neurodegenerative diseases is grounded in breakthrough scientific innovation."       

    About BrainStorm Cell Therapeutics Inc.

    BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company 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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

    For more information, visit the company's website at www.brainstorm-cell.com.

    Safe-Harbor Statement 

    Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; 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.

    Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

    Contacts

    Investor Relations:

    John Mullaly

    LifeSci Advisors, LLC

    Phone: +1 617-429-3548

     

    Media:

    Mariesa Kemble

     

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    SOURCE BrainStorm Cell Therapeutics Inc.

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  3. TEL AVIV, Israel and LISBON, Portugal, Nov. 8, 2021 /PRNewswire/ -- MOV.AI, developer of the revolutionary Robotics Engine PlatformTM, today announced the recent addition of Liat Soffer to its management team, as Chief Financial Officer (CFO).

    Soffer is a seasoned financial executive with over 25 years of experience in finance, accounting, and business leadership. She has a proven track record of scaling start-up operations in the software domain, guiding them all the way from early-stage funding to IPOs.

    "Following the recent launch of the Robotics Engine PlatformTM, MOV.AI has been experiencing strong traction and growth, and we are scaling our operations rapidly," says Motti Kushnir, MOV.AI CEO. "Liat is an experienced CFO that has guided…

    TEL AVIV, Israel and LISBON, Portugal, Nov. 8, 2021 /PRNewswire/ -- MOV.AI, developer of the revolutionary Robotics Engine PlatformTM, today announced the recent addition of Liat Soffer to its management team, as Chief Financial Officer (CFO).

    Soffer is a seasoned financial executive with over 25 years of experience in finance, accounting, and business leadership. She has a proven track record of scaling start-up operations in the software domain, guiding them all the way from early-stage funding to IPOs.

    "Following the recent launch of the Robotics Engine PlatformTM, MOV.AI has been experiencing strong traction and growth, and we are scaling our operations rapidly," says Motti Kushnir, MOV.AI CEO. "Liat is an experienced CFO that has guided the growth of several successful hi-tech companies. She brings a wealth of experience that will help us achieve our goals and deliver great results to both our customers and investors."

    "I am excited to join the MOV.AI team," said Liat Soffer, newly appointed CFO, MOV.AI. "I am passionate about providing real value and driving growth. MOV.AI has great potential based on its technology - a game changer in a market that is forecast to experience tremendous growth - its leadership team and its vision. I look forward to helping make this vision a reality.

    Before joining MOV.AI Liat was CFO at CyberX (Acquired by Microsoft (MSFT),  ForeScout Technologies, Pango Mobile Parking (Sold to Parking by Phone), BrainStorm Cell Therapeutics (NASDAQ:BCLI), and others.

    Liat is also a strong proponent of inclusion and promoting women in technology. As a mentor in the Woman2Woman mentoring program, she is helping women in hi tech reach their full potential. She is also active in the Special Olympics.

    About MOV.AI

    MOV.AI is changing AMRs as we know them.

    It provides AMR manufacturers and integrators with the tools they need to create great robots quickly, allowing users to benefit from automation products that are as flexible as the age we live in.

    Born out of an unmet need, MOV.AI is a ROS-based Robotics Engine PlatformTM packaged in an intuitive web-based interface. It contains everything needed to build, deploy and operate intelligent robots. MOV.AI completely changes the way Autonomous Mobile Robots are developed, in terms of time to market, cost and flexibility.

    Media contact

    Ruth Zamir

    Cision View original content:https://www.prnewswire.com/news-releases/movai-appoints-liat-soffer-as-cfo-to-support-scaling-its-business-301418412.html

    SOURCE MOV.AI

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  4. NEW YORK, Oct. 28, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the appointment of Menghis Bairu, MD, to the company's Board of Directors.  The appointment becomes effective on October 28, 20221.

    BrainStorm Logo

    "I am pleased to welcome Menghis to our Board of Directors," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics.  "Brainstorm will benefit greatly from his expertise and world view, and we look forward to his guidance as we approach a new phase of our mission."

    Menghis Bairu, MD, commented, "I have spent my entire professional life working with organizations and treatments that offer the promise of transformational…

    NEW YORK, Oct. 28, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the appointment of Menghis Bairu, MD, to the company's Board of Directors.  The appointment becomes effective on October 28, 20221.

    BrainStorm Logo

    "I am pleased to welcome Menghis to our Board of Directors," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics.  "Brainstorm will benefit greatly from his expertise and world view, and we look forward to his guidance as we approach a new phase of our mission."

    Menghis Bairu, MD, commented, "I have spent my entire professional life working with organizations and treatments that offer the promise of transformational change for people everywhere, so joining the Brainstorm team is especially appealing to me. I am looking forward to being a part of Brainstorm's science-based and thoughtful approach to developing therapies for neurodegenerative diseases that the world desperately needs."

    Dr. Bairu, a physician, entrepreneur, business executive, editor, author, and philanthropist, is founder, chairman, and CEO of Proxenia Venture Partners, which provides capital, talent management and access to a global network of experts to companies in late preclinical and early-stage clinical development in biotechnology. He is also Chairman and CEO of Bairex, an international medical education and market research organization focused on Africa and the Middle East.

    Sankesh Abbhi, who has served on the board since March 30, 2020 will not be standing for re-election at the Company's annual shareholder meeting.

    Mr. Abbhi commented, "It has been a real privilege to serve on Brainstorm's board and participate in the company's mission and strategy. As a backer of transformative life-sciences, healthcare and technology companies, I continue to support Brainstorm and remain enthusiastic about the potential of its technology to improve the treatment of neurodegenerative diseases for which there are serious unmet needs."

    Mr. Lebovits concluded, "I also want to thank Sankesh, whose counsel and friendship have been invaluable in bringing strength and depth to Brainstorm, helping us reach a pivotal point in a history that we continue to write."

    About Dr. Bairu

    Menghis Bairu, MD, is a physician, entrepreneur, business executive, editor, author, and philanthropist with more than 30 years of international experience in the biotechnology, pharmaceutical, drug delivery and device, global health, and non-profit arenas. He is founder, chairman, and CEO of Proxenia Venture Partners, which provides capital, talent management l, and access to a global networks of experts to companies in late preclinical and early-stage clinical development in biotechnology that address global challenges and improve patient lives. Dr. Bairu also is Chairman and CEO of Bairex, an international medical education and market research organization focused on Africa and the Middle East. Bairex specializes in hands-on educational activities for physicians, clinical trialists, nurses, regulators, pharmacovigilance officers, CROs, and other life science professionals. 

    Prior to founding Proxenia, Dr. Bairu served as Executive Chairman of Treos Bio, a start-up company that uses computational biology to develop precision cancer immunotherapies tailored to patients' genetics. In addition, he is Founder and Chairman Emeritus of Serenus Biotherapeutics, an emerging market focused specialty biopharmaceutical company.

    Dr. Bairu concurrently served as Executive Vice President, Chief Medical Officer, Head of Global Development for Elan and President/CEO of Speranza Therapeutics. As EVP and CMO, Dr. Bairu was member of the Elan's Operating Committee. He successfully led corporate R&D due diligence processes that resulted in a transaction with J&J at a value of approximately $1.5 billion. In 2013, he also led corporate R&D due diligence resulting in the sale of Elan to Perrigo for $8.6 billion. Dr. Bairu worked at Genentech for more than six years in several managed care, medical, and commercial roles for rituximab, Herceptin, TNK, tPA and growth hormone.

    Dr. Bairu currently serves as Adjunct Professor at the University of California, San Francisco School of Medicine, where he lectures on global clinical trials' design, development, and conduct.

    About BrainStorm Cell Therapeutics Inc.

    BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company 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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

    For more information, visit the company's website at www.brainstorm-cell.com.

    Safe-Harbor Statement 

    Statements in this announcement other than historical data and information, including statements regarding future NurOwn® manufacturing and clinical development plans, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; 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:

    Eric Goldstein

    LifeSci Advisors, LLC

    Phone: +1 646.791.9729

     

    Media:

    Mariesa Kemble

    Cision View original content:https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-announces-appointment-of-menghis-bairu-md-to-board-of-directors-301410733.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  5. NEW YORK, Oct. 25, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2021, and provide a corporate update, at 8:00 a.m. Eastern Time on November 15, 2021.

    BrainStorm Logo

    BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David

    NEW YORK, Oct. 25, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2021, and provide a corporate update, at 8:00 a.m. Eastern Time on November 15, 2021.

    BrainStorm Logo

    BrainStorm's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, Stacy Lindborg, PhD, Executive Vice President and Global Head of Clinical Research, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Alla Patlis, CPA, MBA, Interim Chief Financial Officer.

    Participants are encouraged to submit their questions prior to the call by sending them to: . Questions should be submitted by 5:00 p.m. Eastern Time on Sunday, November 14, 2021.

    The investment community may participate in the conference call by dialing the following numbers:

    Participant Numbers:

    Toll Free:                       

    888-506-0062    

    International:                

    973-528-0011 

    Entry Code:                    

    837509

    Webcast URL: 

    https://www.webcaster4.com/Webcast/Page/2354/43351  

    Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website at https://ir.brainstorm-cell.com/overview and clicking on the conference call link.

    Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

    Replay Numbers:

    Toll Free:                     

    877-481-4010      

    International: 

    919-882-2331 

    Replay Passcode: 

    43351

     

    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 produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

    About BrainStorm Cell Therapeutics Inc.

    BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company 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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

    For more information, visit the company's website at www.brainstorm-cell.com.

    Contacts:



    Investor Relations:

    John Mullaly

    LifeSci Advisors, LLC

    Phone: +1 617-429-3548

     

    Media:

    Daniel J. McIntyre

    100 High Street

    Boston, MA 0212

    +1 914-297-8781

    Cision View original content:https://www.prnewswire.com/news-releases/brainstorm-to-announce-third-quarter-financial-results-and-provide-a-corporate-update-301407374.html

    SOURCE Brainstorm Cell Therapeutics Inc

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