BCLI Brainstorm Cell Therapeutics Inc.

12.2
+1.01  (+9%)
Previous Close 11.19
Open 11.3
52 Week Low 3.43
52 Week High 13.61
Market Cap $359,176,930
Shares 29,440,732
Float 26,746,401
Enterprise Value $316,966,791
Volume 658,323
Av. Daily Volume 644,340
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Upcoming Catalysts

Drug Stage Catalyst Date
NurOwn
Amytrophic lateral sclerosis (ALS)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
NurOwn
Prodromal to mild Alzheimer's disease
Phase 2
Phase 2
Phase 2 trial planned.
NurOwn
Progressive Multiple Sclerosis
Phase 2
Phase 2
Phase 2 interim analysis to be performed after 50% of participants have been treated - timing uncertain due to COVID-19.

Latest News

  1. NEW YORK, July 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that final participant dosing has been administered in the Phase 3 pivotal trial of NurOwn® (MSC-NTF cells) in amyotrophic lateral sclerosis (ALS).  The trial enrolled approximately 200 participants, randomized 1:1 to receive three doses of MSC-NTF cells or placebo, administered over four months.  As previously reported, the Company expects top-line data from the trial to be available in the fourth quarter of 2020, consistent with the timeline established upon trial enrollment.

     

    BrainStorm logo

     

    "Completion of participant dosing in this clinical trial is an important milestone…

    NEW YORK, July 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that final participant dosing has been administered in the Phase 3 pivotal trial of NurOwn® (MSC-NTF cells) in amyotrophic lateral sclerosis (ALS).  The trial enrolled approximately 200 participants, randomized 1:1 to receive three doses of MSC-NTF cells or placebo, administered over four months.  As previously reported, the Company expects top-line data from the trial to be available in the fourth quarter of 2020, consistent with the timeline established upon trial enrollment.

     

    BrainStorm logo

     

    "Completion of participant dosing in this clinical trial is an important milestone and brings us a step closer to potentially filing a Biologics License Application to make MSC-NTF cells available to people with ALS," Chaim Lebovits, CEO of BrainStorm stated. "I would like to thank the investigators and their staff at the participating sites for their clinical excellence, especially for enabling this trial to complete on time in the middle of the ongoing COVID-19 pandemic. I must also express my complete gratitude to the trial participants and their loved ones who fully devoted themselves to the challenges of bringing an investigational therapeutic forward. We look forward to the data readout later in 2020."

    The Phase 3 NurOwn trial is being conducted at six centers of excellence: University of California, IrvineCedars-Sinai Medical CenterCalifornia Pacific Medical CenterMassachusetts General HospitalUniversity of Massachusetts Medical School and Mayo Clinic.

    About NurOwn®       

    The NurOwn technology platform (autologous Mesenchymal stem cells, MSC-NTF cells) represent 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 can 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. With this press release, BrainStorm has now fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

    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 status designation 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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. 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 clinical trial enrollment and data, 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, regulatory approval of BrainStorm's NurOwn treatment candidate, the 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 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:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: + 1.862.397.1860

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

     

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-completion-of-all-dosing-in-nurown-phase-3-clinical-trial-in-als-301087537.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  2. NEW YORK, July 1, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, will hold a Key Opinion Leader (KOL) webinar on the Company's Alzheimer's disease (AD) clinical program on Wednesday July 8th at 8.15am ET. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn® in AD.

    BrainStorm Logo

    The webinar will feature presentations by the two lead investigators in BrainStorm's planned international Phase 2 trial in AD: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology…

    NEW YORK, July 1, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, will hold a Key Opinion Leader (KOL) webinar on the Company's Alzheimer's disease (AD) clinical program on Wednesday July 8th at 8.15am ET. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn® in AD.

    BrainStorm Logo

    The webinar will feature presentations by the two lead investigators in BrainStorm's planned international Phase 2 trial in AD: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands; and Bruno Dubois, M.D., Ph.D., Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital in Paris, France. The 52-week, open-label, proof-of-concept clinical trial is designed to evaluate NurOwn® in 40 participants with prodromal to mild AD. It will be conducted at VU University Medical Center (Amsterdam), Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France.

    Philip Scheltens, M.D., Ph.D. received both his M.D. degree (1984) and his Ph.D. in Magnetic Resonance Imaging in Alzheimer's Disease (1993) from VU University in Amsterdam. His main clinical and research interests are Alzheimer's disease, vascular dementia, frontotemporal dementia, magnetic resonance imaging, PET imaging and fluid biomarkers.  He has been the national principal investigator (PI) for over 35 studies, including several Phase 1-3 multicenter clinical trials. Dr. Scheltens founded the Alzheimer Centere at VU University in 2000, and co-founded and assumed the chairmanship of the board of Deltaplan Dementie, the Dutch national plan against dementia, in 2013. He is also the co-editor-in-chief of Alzheimer's Research & Therapy, one of the leading journals in this field.

    Dr. Scheltens has authored more than 1,000 peer-reviewed papers and more than 75 book chapters. He co-edited books on Magnetic Resonance in Dementia and Neuroimaging in Dementia (Springer) as well as Functional Magnetic Resonance Imaging: Clinical Applications (Oxford University Press). In 2011, he was elected to the Royal Dutch Academy of Arts and Sciences (KNAW) and served as Secretary General until 2020. In 2016 he was awarded the European Grand Prix for Alzheimer's Research. He is co-leading and participating in various European Union (EU) projects, including the Innovative Medicines Initiative projects on European Prevention of Alzheimer's Dementia (IMI-EPAD), the Amyloid Imaging to Prevent Alzheimer's Disease (IMI-AMYPAD), the European Medical Information Framework for Alzheimer's Disease (EMIF-AD) and Remote Assessment of Disease and Relapse in Alzheimer's Disease (RADAR-AD).  

    Bruno Dubois, M.D., Ph.D., is Professor of Neurology at the University Salpêtrière Hospital in Paris, Sorbonne-University and Director of the Institute for Memory and Alzheimer Disease (IM2A). He also directs the Expert Memory Center Paris-Sud and the Research INSERM Unit on Cognition and Neuroimaging in Brain Diseases at the Institut du Cerveau et de la Moelle épinière (ICM, Brain and Spine Institute) in Paris. He is Coordinator of the National Reference Centers for Rare Dementias and Young-Onset Alzheimer Disease and of the Paris Center of Excellence in Neurodegeneration (CoEN). Dr. Dubois has published more than 600 peer-reviewed articles on anatomical and biochemical studies of the central cholinergic systems in rodents and humans, as well as on cognition in patients with dementia, with special focus on memory, executive functions and frontal lobe behaviors, and biomarkers in neurodegenerative disorders. He leads an international working group of experts (IWG) on the new criteria for Alzheimer disease. He is principal or co-investigator of several research programs focusing on AD, prodromal AD, and dementia in Parkinson's disease as well as the EU Joint Programme on Neurodegenerative Disease (JPND), IMI-EPAD and IMI- AMYPAD. Dr. Dubois is President of the French Society of Neurology and a member of the National Academy of Medicine.

    Webcast Information

    The webinar will take place on July 8, 2020 at 8:15 AM ET. The presentation will be followed by a question-and-answer session with Professors Scheltens and Dubois and with BrainStorm management.

    Register for Call/Webinar Here

    About NurOwn®  

    NurOwn (autologous MSC-NTF) cells represent 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 can 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

    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 status designation 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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. 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 clinical trial enrollment and data, 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, regulatory approval of BrainStorm's NurOwn treatment candidate, the 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 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:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: + 1.862.397.1860

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-to-showcase-alzheimers-disease-clinical-program-in-kol-webinar-301086826.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  3. NEW YORK, June 24, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced a new clinical program focused on the development of NurOwn® as a treatment for Alzheimer's disease. As part of the newly announced program, the Company is planning a multi-national Phase 2 clinical trial to evaluate the safety and efficacy of NurOwn treatment in patients with prodromal to mild Alzheimer's disease.

    BrainStorm logo

    "Our newly announced Alzheimer's program is an important strategic expansion of BrainStorm's clinical pipeline," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We see this as an ideal complement to our lead amyotrophic lateral sclerosis…

    NEW YORK, June 24, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced a new clinical program focused on the development of NurOwn® as a treatment for Alzheimer's disease. As part of the newly announced program, the Company is planning a multi-national Phase 2 clinical trial to evaluate the safety and efficacy of NurOwn treatment in patients with prodromal to mild Alzheimer's disease.

    BrainStorm logo

    "Our newly announced Alzheimer's program is an important strategic expansion of BrainStorm's clinical pipeline," said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We see this as an ideal complement to our lead amyotrophic lateral sclerosis (ALS) program, as there are compelling data suggesting that the benefits observed with NurOwn in ALS patients may extend to other neurological conditions, including Alzheimer's disease. As we move towards completion of our pivotal Phase 3 ALS study, the newly announced Alzheimer's program, combined with our ongoing progressive multiple sclerosis (MS) program, will continue to drive the advancement of the NurOwn platform. Through the completion of our clinical trial programs, BrainStorm hopes to advance NurOwn to address unmet needs across a broad population of patients with neurodegenerative disease."

    The lead investigators of the trial are two world renowned clinical experts in Alzheimer's disease, Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D. Prof. Scheltens, the principal investigator (PI) of the study, is Professor of Cognitive Neurology and Director of the Alzheimer Centre at Amsterdam University Medical Centers. He has extensive experience as PI of many international clinical trials in this field. Prof. Dubois, the French national coordinator of the study, is Professor of Neurology at the Neurological Institute of the Salpétrière University Hospital. He is President of the Scientific Committee of France-Alzheimer and of IFRAD (International Fund Raising for Alzheimer's Disease) as well as a member of the European Alzheimer Disease Consortium (EADC). Profs. Scheltens and Dubois will discuss the proposed clinical trial during an upcoming Key Opinion Leader (KOL) webinar and call hosted by BrainStorm on July 8, 2020 at 8:15 AM ET.

    Speaking on the trial Prof. Scheltens stated, "We are very eager to evaluate the efficacy of NurOwn in the treatment of Alzheimer's disease, because of its unique mechanism of action. While many previous Alzheimer's therapies have focused on a single target such as tau or beta-amyloid, NurOwn has the capability to simultaneously target multiple relevant biological pathways and bring a comprehensive approach to this multifactorial disease. Importantly, NurOwn's mechanism of action may also allow the therapy to enable synergistic combinations with anti-tau or anti-beta-amyloid treatments, further underscoring its potential to address critical unmet needs in Alzheimer's disease."

    Prof. Dubois added, "In such a complex disease, addressing inflammation and neuro-protection is an innovative and very interesting approach. It is a first in the world for this technology and Brainstorm is leveraging encouraging results from the Phase 2 study in ALS."

    Ralph Kern, M.D., MHSc., President and Chief Medical Officer of BrainStorm, noted, "In the proposed Phase 2 clinical trial, our goal is to confirm that the potential shown by NurOwn in our lead ALS program may be extended to patients with Alzheimer's disease. We now have a compelling set of biomarker data supporting NurOwn's mechanism of action, including important pharmacodynamic changes in cerebrospinal fluid (CSF) inflammatory mediators. Additionally, our innovative biomarker-driven precision medicine approach, which will focus on patients with early-stage disease and pre-defined levels of CSF tau and beta-amyloid proteins, may greatly facilitate Phase 2 clinical trial success."

    Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at BrainStorm, said, "We are excited to introduce a novel approach to Alzheimer's disease that targets both inflammation as well as neurotrophic factors. Given the acute need for vastly different treatment methodologies, we believe our broad targeting approach, combined with robust effects on CSF measures and a favorable safety profile, allows us to go forward with confidence. Additionally, compiling NurOwn safety data across diseases will allow us to enhance patient safety for each trial." 

    Phase 2 Trial to be Conducted at Leading Alzheimer's disease Centers in Europe

    BrainStorm plans to conduct a 52-week, Phase 2 open-label, proof-of-concept clinical trial to evaluate NurOwn in 40 participants with prodromal to mild Alzheimer's disease. Study participants will receive three intrathecal NurOwn doses 8 weeks apart. In addition to meeting well-defined clinical criteria for prodromal to mild Alzheimer's disease, participants must also meet biomarker defined criteria for Alzheimer's disease. The clinical trial will evaluate safety and pharmacodynamics of NurOwn, including effects on inflammatory, Alzheimer's-specific, neurodegenerative, and synaptic biomarkers, as well as a range of key clinical measures of cognition and function. The clinical trial will be conducted at the Brain research Center affiliated with the Alzheimer Center Amsterdam, Pitié-Salpêtrière Hospital (Paris), and several other clinical trial sites in the Netherlands and France.

    NurOwn is protected by patents granted in the United States, Europe, Israel, and elsewhere covering treatments of neurodegenerative diseases, including Alzheimer's disease.  These include European patent no. EP2620493B1 (Mesenchymal stem cells for the treatment of CNS diseases).

    Key Opinion Leader Call and Webcast

    BrainStorm will host a call and webinar featuring Philip Scheltens, M.D., Ph.D., and Bruno Dubois, M.D., Ph.D., on July 8, 2020 at 8:15 AM ET. The webinar will be followed by a question-and-answer session with Professors Scheltens and Dubois.

    Dial-in and Webcast Information

    Register for Call/Webinar Here

    About NurOwn®

    NurOwn (autologous MSC-NTF cells) represent 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 can 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

    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 status designation 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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. 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 clinical trial enrollment and data, 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, regulatory approval of BrainStorm's NurOwn treatment candidate, the 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 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:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: + 1.862.397.1860

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-expands-clinical-pipeline-to-evaluate-nurown-for-the-treatment-of-alzheimers-disease-301082711.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  4. NEW YORK, June 23, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NasdaqCM: BCLI),  a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that its shares will join the Russell 2000® Index and the broad-market Russell 3000® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US stock market opens on June 29, 2020.

     

    BrainStorm Logo

     

    Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 8, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate…

    NEW YORK, June 23, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NasdaqCM: BCLI),  a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that its shares will join the Russell 2000® Index and the broad-market Russell 3000® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US stock market opens on June 29, 2020.

     

    BrainStorm Logo

     

    Annual Russell indexes reconstitution captures the 4,000 largest US stocks as of May 8, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About FTSE Russell

    FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

    FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately $16 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

    A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit http://www.ftserussell.com/.

    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 status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

    Safe-Harbor Statement

    Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, regulatory approval of BrainStorm's NurOwn® treatment candidate, the 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 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:

    Michael Rice

    LifeSci Advisors, LLC

    Phone: +1 646 889 1200

    Public Relations:

    Paul Tyhala

    SmithSolve

    973.442.1555

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-join-the-russell-2000-index-and-russell-3000-index-301081791.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  5. NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency's (EMA) Micro, Small and Medium-Sized Enterprise (SME) office.

    The newly granted SME status allows BrainStorm to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities as well as fee waivers for selective EMA pre and post-authorization regulatory filings, including Orphan Drug and PRIME

    NEW YORK, June 15, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency's (EMA) Micro, Small and Medium-Sized Enterprise (SME) office.

    The newly granted SME status allows BrainStorm to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities as well as fee waivers for selective EMA pre and post-authorization regulatory filings, including Orphan Drug and PRIME designations.

    Brainstorm is also eligible to obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other incentives include EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial burden of the market authorization process.

    "This is an additional and timely step in our global strategy as we continue to engage with the EMEA," said David Setboun, Pharm.D, MBA, Chief Operating Officer of BrainStorm. "Our ALS investigational product received orphan drug status in Europe in July 2013 and we will benefit from the enhanced interaction and early dialogue allowing us to optimize development plans and speed up evaluation in Europe. EMA is facilitating pathways such as PRIME designation that enables critical medicines for major unmet medical need like NurOwn®  to reach patients earlier."

    The EMA plays a central role in facilitating the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies such as BrainStorm to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising new therapeutic options like NurOwn.                                     

    About NurOwn®

    NurOwn® (autologous MSC-NTF) cells represent 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. Autologous MSC-NTF cells can 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. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

    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 status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive Multiple Sclerosis. The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019.

    Safe-Harbor Statement 

    Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, regulatory approval of BrainStorm's NurOwn® treatment candidate, the 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 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:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: +1-862-397-1860

      

    Media:

    Sean Leous

    Westwicke/ICR PR

    Phone: +1-646-677-1839

    Primary Logo

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