BCLI Brainstorm Cell Therapeutics Inc.

10.08
-0.48  -5%
Previous Close 10.56
Open 10.34
52 Week Low 3.58
52 Week High 17.95
Market Cap $318,201,327
Shares 31,567,592
Float 26,696,266
Enterprise Value $306,045,771
Volume 530,829
Av. Daily Volume 622,337
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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 dosing to be completed 4Q 2020.

Latest News

  1. PHILADELPHIA and NEW YORK, Oct. 26, 2020 /PRNewswire/ -- Rapid Reshore & Development (RR&D), an alliance of three specialized firms, and BrainStorm Cell Therapeutics, Inc (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that BrainStorm has selected RR&D as its partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn® (autologous MSC-NTF) in the U.S.

    BrainStorm_Logo

    BrainStorm is investigating NurOwn as a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). BrainStorm's most advanced clinical program for NurOwn is in ALS, which is currently being evaluated in a pivotal Phase 3…

    PHILADELPHIA and NEW YORK, Oct. 26, 2020 /PRNewswire/ -- Rapid Reshore & Development (RR&D), an alliance of three specialized firms, and BrainStorm Cell Therapeutics, Inc (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced that BrainStorm has selected RR&D as its partner to expedite site selection and design services for a state-of-the-art manufacturing facility for NurOwn® (autologous MSC-NTF) in the U.S.

    BrainStorm_Logo

    BrainStorm is investigating NurOwn as a potential treatment for neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS). BrainStorm's most advanced clinical program for NurOwn is in ALS, which is currently being evaluated in a pivotal Phase 3 clinical trial.

    BrainStorm seeks to locate, design and construct a new commercial manufacturing facility in the U.S. to prepare for potential commercialization. RR&D, a three-firm services alliance consisting of EwingCole, Facility Logix and Biggins, Lacy, Shapiro & Company, will identify the location and develop the design of BrainStorm's new commercial manufacturing facility.

    "We're thrilled to be working with BrainStorm on this project and to have the opportunity to deliver this critical work to our region," said EwingCole CEO, Jared Loos, PE, AIA. "We embrace the spirit of creating potentially life-changing technology and we will do everything we can to move the project forward in an efficient and yet responsible manner."

    BrainStorm intends to use the facility primarily for cell therapy production. RR&D will provide custom, streamlined project management, site selection analysis and design/construction management services throughout the project's lifecycle.

    Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics commented, "Our decision to partner with RR&D was driven by the strong capabilities of the individual partners and their holistic approach to planning, site selection and design services. The expansion of BrainStorm's manufacturing capabilities is a key part of our broader corporate strategy to prepare for potential regulatory approvals of NurOwn and becoming a commercial organization. This new partnership follows our recently announced agreement with Catalent Pharma Solutions to manufacture NurOwn at a scale large enough to meet potential commercial needs at the time of launch. The dedicated, state-of-the-art manufacturing facility developed by RR&D will provide us with important long-term autonomy and strategic flexibility, including the capacity to supply NurOwn for additional disease indications beyond ALS.  Together these two partnerships will help ensure that BrainStorm has the manufacturing capacity to meet the needs of patients today and well into the future."

    Site selection analyses will begin immediately with the goal of identifying locations that offer a cost-effective solution for BrainStorm's new manufacturing facility. At the same time, the design team will begin developing a conceptual design of the manufacturing facility, based upon input from BrainStorm's process, engineering, and scientific staff, by defining the main steps of the production process and Current Good Manufacturing Practices (cGMP) requirements. The approximately 50,000 square-foot building will contain manufacturing suites, complementary support and infrastructure, and the ability to expand the facility to 100,000 square feet to anticipate future programmatic needs.

    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) completed enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.

    About Rapid Reshore & Development:

    Rapid Reshore & Development is an alliance of expert firms providing confidence and support throughout the life sciences industry, representing an evolution from transaction-driven service models to a holistic focus on client needs, integrating an interdisciplinary team customized for a variety of individual projects. To optimize and strengthen confidence in decision-making and speed-to-market, Rapid Reshore & Development alliance was formed to deliver best-in-class professionals with deep experience in all aspects of life sciences' project planning, site selection, design and execution including financial, labor market, development incentives, real estate, design and engineering, and construction management. For additional information, visit: www.rapidreshore.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 

    Brainstorm:

    Investor Relations:                                

    Corey Davis, Ph.D.                                

    LifeSci Advisors, LLC                             

    Phone: +1 646-465-1138

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

     

    Rapid Reshore & Development (RR&D):

    Media Contact:

    Zachary DeRitis

    Communications Specialist 

    215-409-4249

    Cision View original content:http://www.prnewswire.com/news-releases/rapid-reshore--development-and-brainstorm-cell-therapeutics-announce-agreement-to-advance-construction-of-brainstorms-us-manufacturing-facility-301159412.html

    SOURCE BrainStorm Cell Therapeutics Inc.; Rapid Reshore & Development (RR&D)

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  2. SOMERSET, N.J. and NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Catalent (NYSE:CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced an agreement for the manufacture of NurOwn®, BrainStorm's autologous cellular therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or motor neuron disease.

    NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote…

    SOMERSET, N.J. and NEW YORK, Oct. 22, 2020 (GLOBE NEWSWIRE) -- Catalent (NYSE:CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced an agreement for the manufacture of NurOwn®, BrainStorm's autologous cellular therapy being investigated for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease or motor neuron disease.

    NurOwn induces mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs) known to promote the survival of neurons and neuroprotection. The therapy has received Fast Track status from the U.S. FDA for ALS and has also been granted Orphan Drug Status for ALS by both the FDA and the European Medicines Agency. BrainStorm is currently completing a 200-patient, double-blind, placebo-controlled, repeat-dosing NurOwn Phase 3 study in the U.S.

    As part of its commitment, Catalent will undertake the transfer of the manufacturing process to, and provide future CGMP clinical supply of NurOwn from, its new, 32,000 square-foot cell therapy manufacturing facility in Houston, Texas. On completion of the clinical trials and in anticipation of potential approval of NurOwn, the companies will look to extend the partnership to include commercial supply from the Houston facility.

    "We are proud to have a partner in Catalent whose excellence in manufacturing quality therapies will support commercial supply of NurOwn," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We know that ALS patients are in urgent need of a new treatment option. If NurOwn is successful in the current clinical trials, this agreement will be integral to ensuring rapid access for patients."

    Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, "Our experience in cell therapy development, and the manufacturing capabilities that our newly constructed, state-of-the-art facility in Houston offers, position us to best support BrainStorm, with its leading therapeutic candidate for ALS treatment. We look forward to partnering with BrainStorm and providing our stem cell manufacturing expertise as we work to optimize production and streamline the product's path towards commercial launch."

    About Catalent Cell & Gene Therapy

    With deep experience in viral vector scale-up and production, Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) and lentiviral vectors, and CAR-T immunotherapies. When it acquired MaSTherCell, Catalent added expertise in autologous and allogeneic cell therapy development and manufacturing to position it as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global cell and gene therapy network of dedicated, large-scale clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. An experienced partner, Catalent Cell & Gene Therapy has worked with industry leaders across 70+ clinical and commercial programs.

    About Catalent

    Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 14,000 people, including around 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

    More products. Better treatments. Reliably supplied.™

    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 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 (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) completed enrollment in August 2020. 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.

    Media Contacts:        

    Catalent   BrainStorm Cell Therapeutics
    Chris Halling

    +44 (0)7580 041073

     Richard Kerns

    +44 (0) 161 728 5880

     Investor Relations:

    Corey Davis, Ph.D.

    LifeSci Advisors, LLC

    Phone: +1 646-465-1138



         
        Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

     

    Primary Logo

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  3. NEW YORK, Oct. 19, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced the presentation of a poster titled, "MSC-NTF (NurOwn®) Exosomes: A Novel Therapeutic Modality in the Mouse LPS-induced ARDS model Analysis" at the NYSCF Conference Meeting, being held virtually. The scientific poster will be presented on October 20.

    POSTER HIGHLIGHTS:

    • One of the most severe complications of the current COVID-19 pandemic is acute respiratory distress syndrome (ARDS). ARDS is caused by increased amounts of pro-inflammatory cytokines, leading to lung damage and loss of lung function.
    • Results from a study in a mouse model of lipopolysaccharide (LPS)-induced ARDS showed that intratracheal administration of NurOwn (MSC-NTF cells) derived exosomes resulted in a statistically significant improvement in multiple lung parameters. These included the clinically relevant factors: functional lung recovery, reduction in pro-inflammatory cytokines and attenuation of lung damage.
    • These positive preclinical results suggest that MSC-NTF exosomes may be suitable as a therapy for COVID-19 induced ARDS, and are more effective at combatting ARDS physiological, pathological, and biochemical symptoms than exosomes isolated from non-induced MSCs.

    "Brainstorm continues to explore the full potential of our proprietary platform cell technology and we are very proud of the therapeutic pipeline advances made by our scientific teams," said Chaim Lebovits, CEO of Brainstorm, "At the same time we remain fully focused on delivering top-line data for our pivotal phase 3 ALS clinical trial as planned and completing the necessary activities to submit a BLA following data review."

    About NYSCF

    The NYSCF Conference is the leading scientific meeting on translational stem cell research. It annually convenes over 500 participants from academia, industry government, non-profits, and patient groups.

    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 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 (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) completed enrollment in August 2020. 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:

    Corey Davis, Ph.D.

    LifeSci Advisors, LLC

    Phone: +1-646-465-1138

    Media:

    Paul Tyahla

    SmithSolve

    Phone: +1-973-713-3768

     

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/brainstorm-announces-scientific-presentation-of-nurown-exosome-preclinical-ards-outcomes-at-the-virtual-new-york-stem-cell-foundation-conference-301154721.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  4. NEW YORK, Oct. 15, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

    BrainStorm_Logo

    "The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn® Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "In parallel to our preparations for upcoming data read out, we are very busy…

    NEW YORK, Oct. 15, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the third quarter ended September 30, 2020, and provided a corporate update.

    BrainStorm_Logo

    "The most important near-term event for BrainStorm will be the upcoming top-line data readout for the NurOwn® Phase 3 trial in ALS, expected by the end of November. A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable new treatment for ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "In parallel to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved, it will be readily accessible to ALS patients in need of new treatment options for this devastating disease."

    NurOwn has an innovative mechanism of action that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently unveiled a clinical development program in Alzheimer's' disease (AD) and is planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France.

    Third Quarter 2020 and Recent Corporate Highlights:

    • Completed dosing of all patients in the ongoing NurOwn Phase 3 clinical trial in ALS and plans remains on track to report top-line data by the end of November 2020.
    • Announced the publication of a manuscript titled "Effects of MSC-NTF cells on T and B regulatory cell function in ALS" in the journal Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration. The manuscript describes NurOwn's immunomodulatory effects on T and B regulatory cell function, suggesting that its mechanism of action is broadly applicable in ALS, PMS and Alzheimer's disease.
    • Presented a scientific poster titled "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting.
    • A Phase 2 trial evaluating NurOwn® as a treatment for progressive multiple sclerosis (PMS) is ongoing at 5 leading U.S. multiple sclerosis centers. The Company remains on track to complete dosing by year end 2020.
    • Presented progressive MS natural history data at the MSVirtual2020 meeting documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients matched to the phase 2 NurOwn clinical trial.
    • Hosted a Key Opinion Leader (KOL) webinar on the Alzheimer's disease program and the planned European Phase 2 trial. The webinar featured presentations by two lead investigators in the trial: Philip Scheltens, M.D., Ph.D., Professor of Cognitive Neurology and Director of the Alzheimer Centre at the 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.
    • Announced a groundbreaking pre-clinical study of a NurOwn® derived exosome-based treatment for COVID-19 acute respiratory distress syndrome (ARDS).
    • Appointed Anthony Waclawski Ph.D. as Executive Vice President, Global Head of Regulatory Affairs.
    • Appointed William K. White as Senior Vice President, Head of Market Access and Pricing.
    • Received a non-dilutive bonus payment of $700,000 from California Institute for Regenerative Medicine (CIRM) for treating more California participants than originally proposed in the Phase 3 ALS trial.
    • Announced the grant of Japanese Patent No. 6,753,887, titled: "Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors".

    Presented at the following Investor Conferences:

    • 40th Annual Canaccord Genuity Growth Conference

    Cash and Liquidity as of October 14, 2020

    Total available funding as of October 14, 2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $36 million.

    Financial Results for the Three Months Ended September 30, 2020

    • Cash and cash equivalents, and short-term bank deposits amounted to approximately $28.8 million at September 30, 2020 compared to $16.2 million at June 30, 2020.
    • Research and development expenses, net for the three months ended September 30, 2020 and 2019 were $1.87 million and $4.01 million, respectively.
      • Excluding participation from IIA and CIRM under the grants and proceeds received under the hospital exemption regulatory pathway, research and development expenses decreased by $1.68 million from $5.66 million in the third quarter of 2019 to $3.98 million in the third quarter of 2020.
    • General and administrative expenses for the three months ended September 30, 2020 and 2019 were $2.62 million and $1.54 million, respectively.
    • Net loss for the three months ended on September 30, 2020 was $4.49 million, as compared to a net loss of $5.63 million for the three months ended September 30, 2019.
      • Net loss per share for the three months ended September 30, 2020 and 2019 was $0.14 and $0.25, respectively.

    Conference Call & Webcast

    Thursday, October 15, 2020 at 8 a.m. Eastern Time

    From the US:              877-407-9205

    International:              201-689-8054

    Webcast:                    https://www.webcaster4.com/Webcast/Page/2354/37811 

    Replays, available through October 29, 2020

    From the US:              877-481-4010

    International:               919-882-2331

    Replay Passcode:       37811



    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 completed enrollment in August 2020.

    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) completed enrollment in August 2020. 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:

    Corey Davis, Ph.D.

    LifeSci Advisors, LLC

    Phone: +1 646-465-1138

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768



     

     

    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands 

     (Except share data)








    September 30, 



    December 31, 





    2020



    2019





    U.S. $ in thousands





    Unaudited



    Audited

    ASSETS













    Current Assets:













    Cash and cash equivalents



    $

    24,770



    $

    536

    Short-term deposit (Note 4)





    4,038





    33

    Other accounts receivable





    1,473





    2,359

    Prepaid expenses and other current assets (Note 5)





    56





    432

    Total current assets





    30,337





    3,360















    Long-Term Assets:













    Prepaid expenses and other long-term assets





    27





    32

    Operating lease right of use asset (Note 6)





    1,377





    2,182

    Property and Equipment, Net





    950





    960

    Total Long-Term Assets





    2,354





    3,174















    Total assets



    $

    32,691



    $

    6,534















    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)













    Current Liabilities:













    Accounts payable



    $

    3,283



    $

    14,677

    Accrued expenses





    917





    1,000

    Operating lease liability (Note 6)





    1,216





    1,263

    Other accounts payable





    1,013





    714

    Total current liabilities





    6,429





    17,654















    Long-Term Liabilities:













    Operating lease liability (Note 6)





    284





    1,103

    Total long-term liabilities





    284





    1,103















    Total liabilities



    $

    6,713



    $

    18,757















    Stockholders' Equity (deficit):













    Stock capital: (Note 7)





    12





    11

    Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30, 2020 and December 31, 2019 respectively.













    Additional paid-in-capital





    163,238





    105,042

    Receipts on account of shares









    Accumulated deficit





    (137,272)





    (117,276)

    Total stockholders' equity (deficit)





    25,978





    (12,223)















    Total liabilities and stockholders' equity



    $

    32,691



    $

    6,534

     

     

     

    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, 





    2020



    2019



    2020



    2019





    Unaudited



    Unaudited



























    Operating expenses:



















































    Research and development, net



    $

    13,509



    $

    11,018



    $

    1,867



    $

    4,008

    General and administrative





    6,684





    4,318





    2,618





    1,543



























    Operating loss





    (20,193)





    (15,336)





    (4,485)





    (5,551)



























    Financial expenses (income), net





    (197)





    225





    3





    83



























    Net loss



    $

    (19,996)



    $

    (15,561)



    $

    (4,488)



    $

    (5,634)



























    Basic and diluted net loss per share from continuing operations



    $

    (0.70)



    $

    (0.72)



    $

    (0.14)



    $

    (0.25)



























    Weighted average number of shares outstanding used in computing basic and diluted net loss per share





    28,695,540





    21,630,007





    31,154,101





    22,254,993

     

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-financial-results-for-the-third-quarter-of-2020-and-provides-a-corporate-update-301153077.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  5. NEW YORK, Oct. 12, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the 2020 Cell & Gene Meeting on the Mesa, being held virtually October 12-16, 2020.

     

    BrainStorm Logo

     

    Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning today. Those who wish to listen to the presentation are required to register here. At the conclusion of the 2020 Cell & Gene Meeting on the Mesa, a copy of the presentation will  also be available in the "Investors and Media" section of the BrainStorm website…

    NEW YORK, Oct. 12, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the 2020 Cell & Gene Meeting on the Mesa, being held virtually October 12-16, 2020.

     

    BrainStorm Logo

     

    Dr. Lindborg's presentation will be in the form of an on-demand webinar that will be available beginning today. Those who wish to listen to the presentation are required to register here. At the conclusion of the 2020 Cell & Gene Meeting on the Mesa, a copy of the presentation will  also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.

    About the 2020 Cell & Gene Meeting on the Mesa

    The conference will feature 80+ on-demand company presentations by leading public and private companies, highlighting their technical and clinical achievements over the past 12 months in the areas of cell therapy, gene therapy, gene editing, and tissue engineering. Registrants will have access to 15+ expert-led panels and workshops including a mix of both live and on-demand sessions. The conference will be delivered in a virtual format over the course of five days – October 12-16. There is also a premier partnering system, partneringONE, allowing registrants to plan 1×1 meetings with other attendees. For a list of presenting companies, refer to https://www.meetingonthemesa.com/company-presentations/.

    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.

    Contacts

    Investor Relations:

    Corey Davis, Ph.D.

    LifeSci Advisors, LLC

    Phone: +1 646-465-1138

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

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

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-to-present-at-the-2020-cell--gene-meeting-on-the-mesa-301150038.html

    SOURCE Brainstorm Cell Therapeutics Inc

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