1. NEW YORK, Nov. 23, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that results from the Company's placebo controlled, randomized, double-blind Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS will be presented as an oral presentation at the 31stInternational Symposium on ALS/MND to be held as a virtual symposium Dec 9-11th, 2020.  In addition, Brainstorm will present the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial in the poster session.

    BrainStorm_Logo

    Each year, the Symposium attracts over 1,000 delegates. It is the largest medical and scientific conference specific to…

    NEW YORK, Nov. 23, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that results from the Company's placebo controlled, randomized, double-blind Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS will be presented as an oral presentation at the 31st International Symposium on ALS/MND to be held as a virtual symposium Dec 9-11th, 2020.  In addition, Brainstorm will present the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial in the poster session.

    BrainStorm_Logo

    Each year, the Symposium attracts over 1,000 delegates. It is the largest medical and scientific conference specific to MND/ALS and is a premier event in the MND research calendar for discussion on the latest advances in research and clinical management.

    The platform presentation will be jointly made by Ralph Kern, MD MHSc, President and Chief Medical Officer of Brainstorm Cell Therapeutics and Merit Cudkowicz MD, one of the Principal Investigators of this trial and the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital on December 9th in Session 3: Clinical Trials from 1110-1130 ET.

    The poster presentation describing the clinical experience with NurOwn outpatient administration during the phase 3 clinical trial will be made by Dr. James Berry, Associate Professor of Neurology, Massachusetts General Hospital, Chief, Division of Motor Neuron Disorders, Massachusetts General Hospital at the virtual poster presentation.

    "We are encouraged by the results of the phase 3 pivotal trial of NurOwn in ALS and are privileged to make these important scientific presentations to the 31st International Symposium on ALS/MND." said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We believe that presentation of these important phase 3 clinical and biomarker outcomes will increase awareness of the potential of NurOwn therapy in ALS and will enable us to listen to the ALS scientific and patient advocacy community as we seek a regulatory pathway forward with our innovative ALS cellular therapy, and hopefully provide a much-needed solution to ALS patients".

    "It is an honor to jointly present our clinical trial results with Dr Cudkowicz on behalf of the study's principal investigators", said Ralph Kern, President and CMO of Brainstorm. "The trial has generated an important set of biomarkers that clearly demonstrates NurOwn's mechanism of action and may help predict ALS treatment response.  We believe that there are important insights from our clinical trial and that NurOwn could potentially benefit ALS patients."

    "The carefully outlined & detailed analysis plan of clinical trial and biomarker data, both finalized prior to viewing the data, provides the framework for generating evidence from this trial.  The Placebo response observed in the NurOwn Phase 3 clinical trial combined with the natural heterogeneity in ALS confounds analysis of clinical trials data", said Stacy Lindborg, EVP and Head of Global Clinical Research. "The process of sharing data with ALS experts, such as a meeting like MND which draws world-renowned ALS physicians and researchers, is critical to producing evidence of NurOwn's treatment effect for patients that will stand over time.  We are progressing our knowledge of the Phase 3 data and look forward to the sharing our latest insights into the Phase 3 trial data with the ALS research community." 

    Study Design

    The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (DrsMerit Cudkowicz, James Berry and Katie Nicholson); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment.  Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

    About NurOwn®

    The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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 completed the Phase 3 pivotal trial in ALS

    (NCT03280056); this trial investigated 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 was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. BrainStorm is also conducting an FDA-cleared 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:


    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:http://www.prnewswire.com/news-releases/brainstorm-to-present-nurown-phase-3-clinical-trial-results-at-31st-international-symposium-on-alsmnd-301178803.html

    SOURCE BrainStorm Cell Therapeutics Inc.

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  2. NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results.

    BrainStorm_Logo

    The Phase 3 clinical trial's primary efficacy endpoint, a…

    NEW YORK, Nov. 17, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline results from the Company's randomized, double-blind placebo-controlled Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for Amyotrophic lateral sclerosis (ALS). Results from the trial showed that NurOwn® was generally well tolerated in this population of rapidly progressing ALS patients. While showing a numerical improvement in the treated group compared to placebo across the primary and key secondary efficacy endpoints, the trial did not reach statistically significant results.

    BrainStorm_Logo

    The Phase 3 clinical trial's primary efficacy endpoint, a responder analysis evaluating the proportion of participants who experienced a 1.25 points per month improvement in the post-treatment Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) slope, was powered on assumed treatment response rates of 35% on NurOwn versus 15% on Placebo. These estimates were based on available historical clinical trial data and the NurOwn Phase 2 data. The primary endpoint was achieved in 34.7% of NurOwn participants versus 27.7% for Placebo (p=0.453).  Therefore, the trial met the expected 35% NurOwn treatment group efficacy response assumption, however the high placebo response exceeded placebo responses observed in contemporary ALS trials.  The secondary efficacy endpoint measuring average change in ALSFRS-R total score from baseline to Week 28, was -5.52 with NurOwn versus -5.88 on Placebo, a difference of 0.36 (p= 0.693).

    In an important, pre-specified subgroup with early disease based on ALSFRS-R baseline score ³ 35, NurOwn demonstrated a clinically meaningful treatment response across the primary and key secondary endpoints and remained consistent with our pre-trial, data-derived assumptions.  In this subgroup, there were 34.6% responders who met the primary endpoint definition on NurOwn and 15.6% on Placebo (p=0.288), and the average change from baseline to week 28 in ALSFRS-R total score was -1.77 on NurOwn and -3.78 on Placebo (p=0.198), an improvement of 2.01 ALSFRS-R points favoring NurOwn.

    Cerebrospinal fluid (CSF) biomarker analyses confirmed that treatment with NurOwn resulted in a statistically significant increase of neurotrophic factors and reduction in neurodegenerative and neuroinflammatory biomarkers that was not observed in the placebo treatment group. We also carried out pre-specified statistical modeling designed to predict clinical response with high sensitivity and specificity based on ALS biomarkers and ALS Function and confirmed that NurOwn treatment outcomes could be predicted by baseline ALS function as well as key CSF neurodegenerative and neuroinflammatory biomarkers.

    Dr. Merit Cudkowicz, one of the Principal Investigators of this trial and the Julianne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital said, "We found a clinically meaningful response to NurOwn in a pre-specified group of patients (greater than or equal to 35 ALSFRS-R at baseline). A change in pre- to post- treatment slope of 1.25 or more is substantial and clinically important. Given the heterogeneity of ALS, it is not surprising that measurement of treatment effect may be influenced by disease severity including the behavior of disease progression rates at the lower end of the scale. It is important to fully explore this finding. In addition, NurOwn was observed to have its clear intended biological effects with important changes in the pre-specified disease and drug related biomarkers."

    "This clinical trial included a more severely affected ALS population compared to other recent ALS clinical trials.  We identified a superior treatment response in a pre-specified subgroup of patients with less advanced disease. We are in active discussions with the FDA who have expressed their eagerness to review the data and have committed to prioritize review of this data.  The FDA will review the data to see if there is a path forward to support approval" said Chaim Lebovits, Chief Executive Officer of BrainStorm. "We would like to sincerely thank the patients, their families and caregivers, investigators and staff who participated in this study, as their dedication and hard work allowed for the study's on-time completion despite the ongoing COVID-19 pandemic.  I also want to thank the California Institute for Regenerative Medicine (CIRM) for their enormous support to conduct this trial." 

    "The findings from this clinical trial demonstrated that NurOwn treatment was associated with a clinically meaningful treatment response and consistent biomarker effects in known ALS disease pathways and that the ability of the clinical trial to demonstrate treatment effects compared to placebo are influenced by baseline disease status, as revealed through ALS function and key biomarkers. We are committed to advancing discussions with the FDA to identify regulatory pathways that may support NurOwn in ALS," commented Ralph Kern MD MHSc, President and CMO of Brainstorm. "In addition to planned scientific engagements, biosamples from this study will be shared through the NEALS biorepository to enable additional scientific discovery efforts. We want to thank our partners, I AM ALS, and ALSA, who kindly supported the biomarker study".

    "The consistency of effect observed across NurOwn treated patients, including within pre-specified subgroups, highlights an important treatment effect in a fatal disease with very limited treatment options. The placebo response observed in this trial is unprecedented and the ability to show treatment benefit in this context provides evidence of the clinical value of NurOwn. The robust changes in biomarkers of Neurodegeneration, including NfL and MCP-1, which allows identification of likely responders prior to treatment is encouraging", said Stacy Lindborg PhD, EVP and Head of Global Clinical Research. "More detailed analyses will be shared at upcoming scientific conferences and in subsequent publications.  We are committed to learning as much as we can from this trial and to partner with the ALS community to progress our collective understanding of ALS, which in turn will help us to continue to bring forward new treatments for this unrelenting disease."

    Study Design

    The Phase 3 NurOwn® trial was a multi-center, placebo-controlled, randomized, double-blind trial designed to evaluate the safety and efficacy of NurOwn® in 189 ALS patients. It was conducted at six centers of excellence: University of California Irvine (Dr. Namita Goyal); Cedars-Sinai Medical Center (Dr. Matthew Burford); California Pacific Medical Center (Prof. Robert Miller); Massachusetts General Hospital (Prof. Merit Cudkowicz, Dr. James Berry); University of Massachusetts Medical School (Prof. Robert Brown) and Mayo Clinic (Prof. Anthony Windebank, Dr. Nathan Staff). Potential participants with ALS were screened during an 18-week run-in period and those who were rapid progressors (defined as patients with at least a 3 point decrease in ALSFRS-R score during the run-in period) were randomized 1:1 to receive three intrathecal injections (8 weeks between each injection) of NurOwn® or placebo. Participants were followed for 28 weeks after treatment. The primary endpoints of the trial were safety assessments and a responder analysis of the rate of decline in ALSFRS-R score over 28 weeks, where response was defined as participants with a ³ 1.25 points/month improvement in the post-treatment versus pre-treatment slope in ALSFRS-R at 28 weeks following the first treatment.  Secondary endpoints included the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

    Conference Call and Webcast Details

    BrainStorm's management team will host a call and webinar to discuss the Phase 3 data today at 8.30 AM EST. The call can be accessed by dialing the numbers below:

    Participant Numbers:

    Toll Free: 877-407-9205

    International: 201-689-8054

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

    Event Link:

    Webcast URL: https://www.webcaster4.com/Webcast/Page/2354/38723   

    Webcast Replay Expiration:

    Wednesday, November 17, 2021

    There will also be a replay of the call which can be accessed by using the webcast link above or by dialing the numbers below. The replay will be available for 14 days.

    Replay Number:

    Toll Free: 877-481-4010

    International: 919-882-2331

    Replay Passcode: 38723

    Teleconference Replay Expiration:

    Tuesday, December 01, 2020

    About NurOwn®

    The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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 completed the Phase 3 pivotal trial in ALS

    (NCT03280056); this trial investigated 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 was intended to support a filing for FDA approval of autologous MSC-NTF cells in ALS and discussion of potential regulatory pathways for approval are planned with the U.S. FDA. BrainStorm is also conducting an FDA-cleared 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 the topline results from the NurOwn® Phase 3 ALS study and 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, the regulatory approval potential 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, if approved, 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 BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern; 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

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-topline-results-from-nurown-phase-3-als-study-301174343.html

    SOURCE BrainStorm Cell Therapeutics Inc.

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  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…

    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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  4. 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

     

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  5. 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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  6. 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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  7. 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

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    SOURCE Brainstorm Cell Therapeutics Inc

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  8. NEW YORK, Oct. 2, 2020 /PRNewswire/ -- BrainStorm-Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on October 15, 2020.

     

    BrainStorm Logo

     

    BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PharmD, MBA, Executive Vice President…

    NEW YORK, Oct. 2, 2020 /PRNewswire/ -- BrainStorm-Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the third quarter ended September 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on October 15, 2020.

     

    BrainStorm Logo

     

    BrainStorm's CEO, Chaim Lebovits, will present a corporate update, after which, participant questions will be answered. Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, President and Chief Medical Officer, David Setboun, PharmD, MBA, Executive Vice President and Chief Operating Officer, and Preetam Shah, PhD, MBA, Executive Vice President and Chief Financial Officer.

    Participants are encouraged to submit their questions prior to the call by sending them to: . Questions should be submitted by 5:00 p.m. EDT, Tuesday, October 13, 2020. 

    Teleconference Details – BRAINSTORM CELL THERAPEUTICS 3Q 2020

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

    Participant Numbers:

    Toll Free: 877-407-9205

    International: 201-689-8054

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

    Event Link: Webcast URL: https://bit.ly/30pVpNG

    Webcast Replay Expiration: Friday, October 15, 2021

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

    Replay Number:

    Toll Free: 877-481-4010

    International: 919-882-2331

    Replay Passcode: 37811

    Teleconference Replay Expiration:

    Thursday, October 29, 2020

    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.

    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:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-announce-third-quarter-financial-results-and-provide-a-corporate-update-301144524.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  9. NEW YORK, Sept. 30, 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, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting, being held virtually. The poster, which will be presented virtually today by Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at Brainstorm, details the design of the Company's placebo-controlled, randomized, double-blind, Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS patients.

    BrainStorm Cell Therapeutics

    "This pivotal study has been rigorously designed and powered to detect clinically meaningful…

    NEW YORK, Sept. 30, 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, "Advancing NurOwn® for ALS: Phase 3 Clinical Trial Design" at the Annual Northeast ALS (NEALS) Meeting, being held virtually. The poster, which will be presented virtually today by Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research at Brainstorm, details the design of the Company's placebo-controlled, randomized, double-blind, Phase 3 trial evaluating NurOwn® (MSC-NTF cells) as a treatment for ALS patients.

    BrainStorm Cell Therapeutics

    "This pivotal study has been rigorously designed and powered to detect clinically meaningful effects of NurOwn® in rapidly progressing ALS patients," said Dr. Lindborg. "Compelling Phase 2 data showed that a single NurOwn® administration slowed disease progression in this patient population, and the current Phase 3 trial aims to confirm this effect in a larger study cohort and show that its duration can be extended through repeated administrations. To test this hypothesis, we are comparing the rate of patient level decline in ALS disease as measured by the ALS Functional Rating Scale between the pre-treatment period to the rate of decline observed after the initiation of treatment. Such an analysis allows us to compare the magnitude of change in disease progression resulting from NurOwn® and placebo treatments while accounting for important variable factors known to influence disease progression. We look forward to sharing the results of this analysis later this year."

    The poster will be discussed by Dr. Lindborg during a live session at NEALS. A copy of the poster will be also be available in the "Investors and Media" section of the BrainStorm website under Events and Presentations.

    About the Phase 3 NurOwn® Trial

    The Phase 3 NurOwn® trial is a placebo-controlled, randomized, double-blind trial 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. Patient dosing in the trial is complete and topline data is expected in 4Q-2020. The primary endpoint of the trial is a responder analysis of the rate of decline in ALS Functional Rating Scale (ALSFRS-R) score over 28 weeks. Secondary endpoints include safety, the percentage of patients with disease progression halted or improved, ALSFRS-R change from baseline, combined analysis of function and survival, slow vital capacity, tracheostomy-free survival, overall survival and cerebrospinal fluid biomarker measurements. For more information on the trial, visit https://clinicaltrials.gov/ct2/show/NCT03280056.

    About NEALS

    The Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium is a multi-function organization that aims to translate scientific advances into new treatments for people with ALS and motor neuron disease (MND) as rapidly as possible. To achieve its goal, NEALS functions as an academic research consortium, a contracted research organization, and a resource tool for the ALS community. NEALS is committed to the principles of open scientific communication, peer review, full and open disclosure of potential conflicts of interest, and democratic governance of its organization and activities. For more information on NEALS, visit https://www.neals.org/.

    About NurOwn®

    The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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); this trial is 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 FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved 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) is fully enrolled.

    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

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-scientific-presentation-at-the-annual-neals-meeting-301141696.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  10. NEW YORK, Sept. 29, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of William K. White as senior vice president, head of market access and pricing. Mr. White has more than 25 years' experience in leading successful product commercialization and securing market access for innovative new medicines.

    BrainStorm_Logo

    "Bill has an extensive track record working with public and private payers to help secure patient access to innovative therapies, and brings an important skill set to BrainStorm. His appointment is part of a strategic initiative to build a senior team with proven commercial capabilities," commented Chaim Lebovits

    NEW YORK, Sept. 29, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of William K. White as senior vice president, head of market access and pricing. Mr. White has more than 25 years' experience in leading successful product commercialization and securing market access for innovative new medicines.

    BrainStorm_Logo

    "Bill has an extensive track record working with public and private payers to help secure patient access to innovative therapies, and brings an important skill set to BrainStorm. His appointment is part of a strategic initiative to build a senior team with proven commercial capabilities," commented Chaim Lebovits, BrainStorm's Chief Executive Officer. "Bill's experience will help us develop market access, patient services and distribution strategies that will be vital to the timely and efficient market entry of NurOwn® for ALS, assuming its approval by the FDA."  

    William White commented, "The life-changing potential of the investigational NurOwn technology platform, which is nearing completion of its Phase 3 pivotal trial in amyotrophic lateral sclerosis, makes this an opportune time to join BrainStorm. I look forward to leading a team that will help ensure, if approved by the FDA, that NurOwn is covered by insurers and is readily accessible to patients in need. I am proud to join a company with such visionary leadership and enormous growth potential, and I am excited about helping BrainStorm to deliver on its promise of bringing autologous cellular therapies to patients with debilitating neurodegenerative diseases."

    Mr. White was most recently Vice President of Patient and Market Access at Avexis, now Novartis Gene Therapies. While at Avexis, he led a large team responsible for securing reimbursement and developing patient support services with national and regional insurers and state Medicaid payers. His work in developing and implementing the market access strategy for AVXS-101/Zolgensma® helped to expedite delivery of a novel new treatment to an underserved patient population and helped the company transition to the commercial stage. Mr. White has also held leadership positions in managed care and patient access at Insys Therapeutics and Lundbeck (formerly Ovation Pharmaceuticals).

    In addition to his specialization in market access, reimbursement and distribution design and implementation, Mr. White has expertise in rare/orphan diseases, gene therapy, neuromuscular disease, managed care, and leadership development. He holds a B.S. in Business Administration from Rider University.

    About NurOwn®             

    The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational cellular 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 culture 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.

    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 and dosed a phase 3 pivotal trial in ALS (NCT03280056); this trial is investigating repeat-intrathecal 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 BLA filing for FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) that is now fully enrolled (NCT03799718).

    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

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-appoints-william-k-white-as-senior-vice-president-head-of-market-access--pricing-301139589.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  11. NEW YORK, Sept. 16, 2020 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the Japanese Patent Office (JPO) has granted Brainstorm's Japanese Patent, number: 6,753,887, titled: 'Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors'.

    BrianStorm Logo

    The allowed claims cover a method of generating cells which secrete neurotrophic factors from human undifferentiated mesenchymal stem cells (MSCs) derived from the bone marrow of a single donor. The said neurotrophic factors includes: brain derived neurotrophic factor (BDNF); glial derived neurotrophic factor (GDNF); hepatocyte growth factor (HGF); and vascular endothelial…

    NEW YORK, Sept. 16, 2020 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the Japanese Patent Office (JPO) has granted Brainstorm's Japanese Patent, number: 6,753,887, titled: 'Methods of Generating Mesenchymal Stem Cells which Secrete Neurotrophic Factors'.

    BrianStorm Logo

    The allowed claims cover a method of generating cells which secrete neurotrophic factors from human undifferentiated mesenchymal stem cells (MSCs) derived from the bone marrow of a single donor. The said neurotrophic factors includes: brain derived neurotrophic factor (BDNF); glial derived neurotrophic factor (GDNF); hepatocyte growth factor (HGF); and vascular endothelial growth factor (VEGF).

    Patent families protecting NurOwn® manufacturing have been issued in the United States, Japan, Europe, Hong-Kong and Israel.

    "We are extremely pleased with the continued development of our patent portfolio protecting our technology through strategic intellectual property achievements.  This new patent grant from the Japanese Patent Office is an important addition to our IP portfolio for the NurOwn® technology and is an important element of our business strategy" commented Brainstorm's CEO Chaim Lebovits. 

    David Setboun, PharmD MBA, EVP and Chief Operating Officer, added: "Having our cell therapy product patented in Japan will increase our ability to enter into new commercial partnerships for NurOwn® in Japan."

    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 is currently conducting 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 its Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., 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 received U.S. FDA clearance to run 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. For more information, visit the company's website at www.brainstorm-cell.com

    Safe-Harbor Statements      

    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-announces-grant-of-a-new-japanese-patent-for-nurown-301132200.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  12. Jerusalem, (Wiredrelease):InnoCan Pharma (CSE:INNO) is announcing a worldwide exclusive license agreement with the Hebrew University of Jerusalem to develop a first-of-its-kind CBD drug delivery platform based on liposomes.

    This Patent-Pending platform is based on a unique-controlled liposome-release method to be administrated, for the first time, by injection, turning Pharma Cannabinoids-based Medicines to an ever-accessible injectable drug.

    Liposomes are changing the way we perceive Cannabinoids. A recent HebrewU research shows that the liposomes succeed to maintain the CBD level in the blood for few weeks, compared to 24-36 hours of CBD administrated without the Liposomes.  

    As Isolated CBD is an oily molecule, it cannot be normally injected…

    Jerusalem, (Wiredrelease):InnoCan Pharma (CSE:INNO) is announcing a worldwide exclusive license agreement with the Hebrew University of Jerusalem to develop a first-of-its-kind CBD drug delivery platform based on liposomes.

    This Patent-Pending platform is based on a unique-controlled liposome-release method to be administrated, for the first time, by injection, turning Pharma Cannabinoids-based Medicines to an ever-accessible injectable drug.

    Liposomes are changing the way we perceive Cannabinoids. A recent HebrewU research shows that the liposomes succeed to maintain the CBD level in the blood for few weeks, compared to 24-36 hours of CBD administrated without the Liposomes.  

    As Isolated CBD is an oily molecule, it cannot be normally injected into the body, as it may cause severe pain and other side effects. Furthermore, CBD lives in the blood stream for no longer than 24 hours, allowing a very short therapeutic window. Today, CBD is usually been administrated by smoking or by oil drops leading to CBD to remain in the blood stream for no more than 36 hours and, in the case of oil drops, 80% of the CBD dose will be destroyed in the liver.

    In both cases, the actual dose the patient gets is not precise as there is no way to measure the exact amount of CBD given to the patient, a needed criterion to approve CBD as a drug. That is where the magic happens, as InnoCan Pharma’s new technique includes an exact dose of CBD inside a liposome, allowing precise measurement, making the drug injectable as easily as injecting insulin.

     “This accurate, controlled administration of CBD by injection”, says Prof. Chezy Barenholz, Head of the Laboratory of Membrane and Liposome Research of the Hebrew University – Jerusalem, “Is expected to be a game-changer in the health sector. One that signals a breakthrough in the pharmaceutical industry”.

    “It can be beneficial to individuals who are suffering from chronic pain, as they can receive injection once in few weeks”, adds Prof. Barenholz, “And over time, one could have a consistent release of CBD into the body”.

    Cannabinoid Pharma market

    Increasing evidence from medical-science about the benefits that Cannabiods and its derivatives have on health and well-being, moves investors from curiosity to an increased interest in participating in what is already anticipated as a multi-million dollar global business.

    According to a report by Grand View Research, Inc, “The global Cannabis pharmaceuticals market size is projected to reach $5.8 billion by 2027, expanding at a CAGR of 76.8% over the forecast period.”

    Cannabis has been shown to have immense medicinal potential. A variety of studies by prestigious universities around the world demonstrates the immense therapeutic effectiveness of Cannabinoids in the treatment of various conditions.

    Epilepsy, neuropathic and chronic pain, sleep disorders, anxiety, arthritis, the adverse effects of cancer treatment, multiple sclerosis, and several others, are multi-Billion USD scope problems, that becoming more relying on CBD innovations.  

    The United States and Canada are the biggest players in that field. Canada, both regulation and business-wise, has a flourishing Cannabinoid pharma market and is home to many of the biggest Cannabis companies on the globe.

    Canadian therapeutic pipelines for Cannabinoids have grown in leaps and bounds. Tilray (NASDAQ:TLRY) Chief Executive Officer, Brendan Kennedy remarked that “Canada has the potential to be a global leader in exporting medical cannabis as a biotech and pharma product”.

    InnoCan Pharma

    InnoCan Pharma Corporation (CSE:INNO) is considered a rising leading pharmaceutical tech company that focuses on the development of several drug delivery platforms. It is known and accredited for the proprietary ability of combining Cannabinoids (“CBD”) with other pharmaceutical ingredients as well as of the development and sale of CBD-integrated pharmaceuticals.

    InnoCan Pharma was founded by Israeli serial entrepreneur, Yoram Drucker, who is known for founding and leading major Pharma Exits, Pluristem (NASDAQ:PSTI) & Brainstorm (NASDAQ:BCLI), in the field of stem cells.

    Leading the company is CEO Iris Bincovich, an experienced healthcare Executive, joined by Ron Mayron, former CEO of Teva IL ((TLV: TEVA, NYSE:TEVA), one of the largest generic pharmaceutical companies in the world.

    Its Research and Development efforts are led by significant world-renowned players like Prof. Chezy Barenholz, Head of the Laboratory of Membrane and Liposome Research of the Hebrew University – Jerusalem and Prof. Daniel Offen, a leading researcher specializing in Neuroscience and Exosome technology, Head of the Department of Human Molecular Genetics and Biochemistry at Tel Aviv University.

    This content has been published by Boost SEO Metrics company. The WiredRelease News Department was not involved in the creation of this content. For press release service enquiry, please reach us at .

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  13. Advanced Therapies & Expo 2020 on September 9

    CIRM 2020 Grantee Meeting on September 14

    Collaborations That Transform MS Webinar on September 24 

    NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it will deliver virtual presentations during Advanced Therapies & Expo 2020, September 9, at the 2020 CIRM Grantee Meeting, September 14, 2020, and at the WuXi Apptec Collaborations That Transform Meeting focusing on Multiple Sclerosis, September 24, 2020.

    Advanced Therapies & Expo
    Presentation Title:Stem Cells for neurological applications, clinical and stem cells-based product development 
    Presenter:

    Advanced Therapies & Expo 2020 on September 9

    CIRM 2020 Grantee Meeting on September 14

    Collaborations That Transform MS Webinar on September 24 

    NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that it will deliver virtual presentations during Advanced Therapies & Expo 2020, September 9, at the 2020 CIRM Grantee Meeting, September 14, 2020, and at the WuXi Apptec Collaborations That Transform Meeting focusing on Multiple Sclerosis, September 24, 2020.

    Advanced Therapies & Expo
    Presentation Title:Stem Cells for neurological applications, clinical and stem cells-based product development 
    Presenter:Ralph Kern MD MHSc, President and Chief Medical Officer
    Time:September 9 at 10am BST
    Webcast:https://www.terrapinn.com/congress/advanced-therapies/index.stm
    Session:Channel 4 – Stem Cells & Regenerative Medicine
      
    Panel:Stem Cells & Regenerative Medicine Q&A
    Presenter:Ralph Kern MD MHSc, President and Chief Medical Officer
    Time:September 9 at 1-1.30pm BST
    Session:Channel 4 – Stem Cells & Regenerative Medicine
      
    2020 CIRM Grantee Meeting
    Presenter:Ralph Kern, MD, MHSc, President and Chief Medical Officer
    Time:September 14 at 9.40 – 9.55am PT (panel discussion 10.25 - 10.40am PT)
    Webcast:Register here to get access to the Zoom link.
    Session:Neurodegenerative Diseases
      
    WuXi Apptec- Collaborations That Transform Meeting (Multiple Sclerosis)
    Presenter:Ralph Kern, MD, MHSc, President and Chief Medical Officer
    Time:September 24, 2020 10:30 AM– 12:30 PM ET
    Webcast:Link will be posted on the Events and Presentations page of Brainstorm's corporate website when available (panel discussion to follow)

    Participants can view the presentations via the event links and those unable to join will have access to an archived link on the Company's Events and Presentation webpage after the conclusion of the conferences.

    BrainStorm is the recipient a non-dilutive grant of $16 million by California Institute for Regenerative Medicine (CIRM) to support the ongoing Phase 3 study of NurOwn®, for the treatment of amyotrophic lateral sclerosis (ALS).   

    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

    Primary Logo

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  14. NEW YORK, Sept. 02, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of Anthony P. Waclawski, Ph.D. as Executive Vice President, Global Head of Regulatory Affairs.  Dr. Waclawski is an industry veteran and a recognized leader in regulatory affairs with over 35 years of multinational experience in the FDA regulatory approval process, including Biologics License Applications (BLAs), New Drug Applications (NDAs), and FDA Advisory Committees.

    "Tony's unique regulatory experience within one of the largest global pharmaceuticals, makes him exceptionally well qualified to join the BrainStorm leadership team…

    NEW YORK, Sept. 02, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the appointment of Anthony P. Waclawski, Ph.D. as Executive Vice President, Global Head of Regulatory Affairs.  Dr. Waclawski is an industry veteran and a recognized leader in regulatory affairs with over 35 years of multinational experience in the FDA regulatory approval process, including Biologics License Applications (BLAs), New Drug Applications (NDAs), and FDA Advisory Committees.

    "Tony's unique regulatory experience within one of the largest global pharmaceuticals, makes him exceptionally well qualified to join the BrainStorm leadership team," commented Chaim Lebovits, BrainStorm's Chief Executive Officer.  "He has held leadership roles in many of the key functions of regulatory, including regulatory strategy and operations, establishing a track record of success for many development stage and marketed products.  Dr. Waclawski will enhance our global regulatory strategy, as we work to bring better treatment options to patients afflicted with ALS and other neurodegenerative diseases. We look forward to the strategic contributions and key insights he will bring to BrainStorm."     

    Anthony Waclawski commented, "I'm very excited to join the team at BrainStorm and do all I can to help bring new therapies to patients with ALS and other neurodegenerative diseases.  This is a challenging area for drug development and there is a critical need for effective and safe therapies."

    Prior to his appointment at BrainStorm, Dr. Waclawski spent 35 years of increasing responsibility at Bristol-Myers Squibb, most recently as Vice President and Head, Regulatory and Pharmaceutical Sciences, Cardiovascular, Immunosciences, Fibrosis, and Genetically-defined diseases. In this role, he was responsible for the strategic and operational deliverables of regulatory, biostatistics, clinical pharmacology, and pharmacometrics for the development assets in these areas.  Dr. Waclawski's experience spans a broad range of regulatory capabilities across multiple therapeutic areas and geographies, guiding successful FDA interactions and establishing and executing successful global regulatory strategies. 

    Dr. Waclawski holds a Ph.D. in Pharmaceutical Sciences, a Master of Pharmaceutical Science, and a Bachelor of Science in Pharmacy from Rutgers University. 

    About NurOwn®

    The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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); this trial is 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 FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved 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:

    Corey Davis, Ph.D.

    LifeSci Advisors, LLC

    Phone: +1 646-465-1138

    Media:

    Paul Tyahla

    SmithSolve

    Phone: + 1.973.713.3768

    Primary Logo

    View Full Article Hide Full Article
  15. NEW YORK, Aug. 25, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the acceptance of a clinical abstract documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients with progressive multiple sclerosis (MS). The data, to be presented as a poster on September 11-13 at the forthcoming MSVirtual2020 meeting – the eighth joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – will inform analysis of clinical outcomes in the Company's ongoing Phase…

    NEW YORK, Aug. 25, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today the acceptance of a clinical abstract documenting an association between magnetic resonance imaging (MRI) measures and functional improvement in patients with progressive multiple sclerosis (MS). The data, to be presented as a poster on September 11-13 at the forthcoming MSVirtual2020 meeting – the eighth joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) – will inform analysis of clinical outcomes in the Company's ongoing Phase 2 trial of NurOwn® (MSC-NTF cells) in patients with progressive MS. 

     

    BrainStorm Logo

     

    "Although disability improvement is an important measure of function in individuals with progressive MS, the MRI features that correlate with disability improvement had not previously been explored," noted Tanuja Chitnis, M.D., FAAN, Professor of Neurology at Harvard Medical School, Senior Neurologist at Brigham and Women's Hospital, and Director of the Comprehensive Longitudinal Investigations in MS at the Brigham (CLIMB Study). "In this analysis, we have demonstrated a correlation between specific brain and spinal cord MRI measures and observed functional improvements in progressive MS patients. We are grateful to the joint ACTRIMS/ECTRIMS abstract committee for allowing us to present these data, which we hope will facilitate analysis of clinical trial outcomes that specifically evaluate functional improvements in progressive MS."  

    Dr. Chitnis and colleagues evaluated MRI features of 48 participants in the SysteMS substudy of the CLIMB study, a nested cohort selected to match the inclusion criteria of the Phase 2 NurOwn trial in progressive MS (NCT03799718). The participants underwent brain and lesion volumetric analysis, as well as mean upper cervical cord (MUCCA) analysis, 12-24 months following baseline 3 Tesla MRI. These analyses generated 34 MRI data measures performed by ICOMETRIX, which the investigators compared in patients with improved function versus those with worsening or stable function, as measured by 9-hole peg test (9HPT) or timed-25-foot-walk (T25FW) scores, two well-established measures of function in progressive MS.

    Seventeen patients had improved 9HPT scores from baseline to 12-24 months later, compared to 29 with worsened or stable 9HPT scores over that same period. Whole brain volume at baseline (improved 9HPT: 1505±51 vs. stable-worse 9HPT: 1471±62; p=0.069; t-test) and follow-up (improved: 1501.555±52.039 vs. stable-worse: 1461.304±63.562; p=0.03; t-test) differed between the two 9HPT groups, as did gray matter volume at follow-up (improved 1505.059 ±50.961 vs. stable-worse 865.57±41.352; p=0.063: t-test). Eighteen patients had an improved T25FW score, compared to 27 whose score worsened or remained stable over the 12-month period. Deep white matter FLAIR/T2 lesion volume at baseline (improved: 0.43±0.507 vs. stable-worse: 0.827±0.561; p=0.03; t-test) and follow-up (improved: 0.429±0.503 vs. stable-worse: 0.864±0.603; p=0.02) differed between the two T25FW groups. The investigators did not observe any association between MUCCA and functional improvement measures.

    Chaim Lebovits, Chief Executive Officer of BrainStorm stated "The important MRI correlations with measures of functional improvement in this matched natural history cohort will provide helpful context as we evaluate the clinical outcomes from our ongoing Phase 2 trial of NurOwn in patients with progressive MS and hopefully bring us a step closer to offering a new treatment option to individuals living with this devastating disease."

    About NurOwn®

    The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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); this trial is 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 FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved 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 fo/rward-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

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-to-present-data-linking-mri-measures-to-functional-improvement-in-progressive-multiple-sclerosis-ms-301117815.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  16. NEW YORK, Aug. 19, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today 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.

     

    BrainStorm Logo

     

    NurOwn® (MSC-NTF cells) are autologous, mesenchymal stem cells induced by a culture-based approach to secrete significant higher levels of neurotrophic factors while retaining their intrinsic immunomodulatory activity. Brainstorm has demonstrated that a single administration of NurOwn increased circulating T regulatory cells in a phase 2a open label study and reduced cerebrospinal…

    NEW YORK, Aug. 19, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today 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.

     

    BrainStorm Logo

     

    NurOwn® (MSC-NTF cells) are autologous, mesenchymal stem cells induced by a culture-based approach to secrete significant higher levels of neurotrophic factors while retaining their intrinsic immunomodulatory activity. Brainstorm has demonstrated that a single administration of NurOwn increased circulating T regulatory cells in a phase 2a open label study and reduced cerebrospinal fluid (CSF) inflammatory biomarkers in a phase 2 randomized clinical study.  To explore the link between these important biomarker observations, Brainstorm conducted a series of preclinical experiments in order to evaluate the potential of NurOwn to induce T and B regulatory cells and IL-10 secretion and confirm their immunomodulatory effects. Decreased T and B regulatory function appears to impact disease progression in ALS and other neuroinflammatory diseases.  T and B cell secreted IL-10 may enhance microglia and cytokine networks and have shown therapeutic potential in ALS and neuroinflammatory preclinical models.  

    In the preclinical experiments, a significant (p<0.0001) decrease of interferon-g secretion by peripheral blood mononuclear cells (PBMC) in the presence of NurOwn® was demonstrated. When co-cultured with PBMC, NurOwn® induced CD4+CD25+FoxP3+ T regulatory cells (p < 0.001). When cocultured with B cells, NurOwn induced CD24hiCD38hi B regulatory cells, and increased IL-10 secretion (p < 0.001).

    "These preclinical observations extend the understanding of immunomodulatory effects of NurOwn on CSF inflammatory biomarkers demonstrated in the US phase 2 randomized clinical trial by providing specific mechanisms by which NurOwn may exert its beneficial effects on these important cytokine pathways," said Ralph Kern MD MHSc, President and Chief Medical Officer of Brainstorm.

    Chaim Lebovits, Brainstorm Chief Executive Officer added, "We continue to expand our scientific knowledge of NurOwn's mechanism of action through preclinical and clinical research.  Our goal is to efficiently bring practical solutions to patients in need, through innovative science, completion of the phase 3 ALS clinical trial and advancement of clinical programs in progressive MS and Alzheimer's disease."

    About NurOwn®

    The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells 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.

    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); this trial is 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 FDA approval of autologous MSC-NTF cells in ALS. BrainStorm is also conducting an FDA-approved 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 fo/rward-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

     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-publication-of-new-preclinical-data-supporting-proposed-nurown-mechanism-in-als-progressive-ms-and-alzheimers-disease-301114814.html

    SOURCE BrainStorm Cell Therapeutics Inc.

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  17. NEW YORK, Aug. 10, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Ralph Kern, MD, MHSc, President and Chief Medical Officer, will present a corporate overview during the 40th Annual Canaccord Genuity Growth Conference, to be held virtually August 11-13, 2020. Company management will also be available for 1on1 meetings with institutional investors via video conference on the day of the presentation. To request a meeting, please contact your representative at Canaccord Genuity.

    Participants can view the presentation via the event link and those unable to join will have access to an archived link on the Company's Events and Presentation webpage after the conclusion of the conference.

    Event:   40th Annual Canaccord Genuity Growth Conference

    Time:   August 13, 2020 @ 3:30pm ET

    Webcast:   https://bit.ly/3fFxqPr

    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:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: + 1.862.397.1860

    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-to-present-at-the-40th-annual-canaccord-genuity-growth-conference-301109005.html

    SOURCE Brainstorm Cell Therapeutics Inc

    View Full Article Hide Full Article
  18. NEW YORK, Aug. 5, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the second quarter and first half ended June 30, 2020, and provided a corporate update.

    BrainStorm_Logo

    "Despite the impact of COVID-19 on healthcare access, we completed enrollment and dosing of our Phase 3 ALS clinical trial and expanded our pipeline across new indications," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We want to recognize and thank the relentless dedication of the trial participants, their loved ones, our investigators and the team here at BrainStorm for this outstanding achievement. We expect a topline data…

    NEW YORK, Aug. 5, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the second quarter and first half ended June 30, 2020, and provided a corporate update.

    BrainStorm_Logo

    "Despite the impact of COVID-19 on healthcare access, we completed enrollment and dosing of our Phase 3 ALS clinical trial and expanded our pipeline across new indications," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "We want to recognize and thank the relentless dedication of the trial participants, their loved ones, our investigators and the team here at BrainStorm for this outstanding achievement. We expect a topline data readout by the end of November this year."

    The application of NurOwn® as a platform technology in neurodegenerative disease has great potential and we are actively investing in clinical trials to evaluate the product in other conditions beyond ALS. The Phase 2 clinical trial ongoing in progressive multiple sclerosis (PMS) is expected to complete dosing by the end of 2020. In addition, we recently unveiled a clinical development program in Alzheimer's disease and are planning a Phase 2 proof-of-concept clinical trial at several leading AD centers in the Netherlands and France. We believe that leveraging the NurOwn platform and potentially bringing much needed innovative treatment options to patients across multiple diseases will result in value creation for our various stakeholders.

    Second Quarter 2020 and Recent Corporate Highlights:

    • Completed dosing of all patients in the ongoing NurOwn Phase 3 clinical trial in amyotrophic lateral sclerosis (ALS).
    • NurOwn is being investigated in a Phase 2 clinical trial in patients with progressive multiple sclerosis (PMS) which is ongoing at 5 leading U.S. MS centers. As of August 4, 2020, all 20 study participants have been enrolled in the study and dosing is expected to be completed by the end of 2020.
    • Announced a new clinical program focused on NurOwn as a treatment for Alzheimer's disease (AD). The Company is planning a multi-national Phase 2 clinical trial in Europe in patients with prodromal to mild AD.
    • The Alzheimer's disease program and Phase 2 trial were featured in a Key Opinion Leader (KOL) webinar on July 8.
    • Announced groundbreaking pre-clinical study of NurOwn derived exosome-based treatment for Covid-19 ARDS.
    • Granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency
    • Announced leasing of three state-of-the-art cleanrooms, at the Tel Aviv Sourasky Medical Center to increase manufacturing capability for EU and the local Israeli market
    • Awarded $0.5 Million by The ALS Association and IAMALS for ALS Biomarker Study
    • Professor Jacob Frankel appointed as Chairman of the Board of Directors
    • Appointed Stacy R. Lindborg Ph.D. as Executive Vice President, Head of Global Clinical Research
    • Appointed David Setboun as Executive Vice President and Chief Operating Officer
    • Presented new data highlighting NurOwn immunomodulation in Neurology Journal
    • Awarded $1.5 million grant for 2020 by the Israel Innovation Authority
    • Received non-dilutive bonus payment of $700,000 from CIRM for treating more California participants than originally proposed in our Phase 3 ALS clinical trial.
    • Joined the Russell 2000® and Russel 3000® Indexes

    Presented at the following Investor Conferences:

    • Raymond James Human Health Innovations Conference
    • BIO Digital 2020

    Cash and Liquidity as of July 31, 2020

    Total available funding as of July 31, 2020, which includes cash on hand of approximately $34.7 million as well as remaining non-dilutive funding from CIRM, IIA and other grants, amounts to approximately $37.5 million.

    Financial Results for the Three Months Ended June 30, 2020

    • Cash, cash equivalents, and short-term bank deposits were approximately $16.2 million as of June 30, 2020, compared to $6.2 million on March 31, 2019.
    • Research and development expenses, net for the three months ended June 30, 2020 and 2019 were $5.69 million and $3.55 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 $520,000 from $6.54 million in the second quarter of 2019 to $6.02 million in the second quarter of 2020.
    • General and administrative expenses for the three months ended June 30, 2020 and 2019 were $1.71 million and $1.30 million, respectively.
    • Net loss for the three months ended June 30, 2020 was $7.39 million, as compared to a net loss of $4.90 million for the three months ended June 30, 2019.

         -   Net loss per share for the three months ended June 30, 2020 and 2019 was $0.25 and $0.23, respectively.

    Conference Call & Webcast

    Wednesday, August 5, 2020 at 8am Eastern Time

    From the US:              877-407-9205

    International:               201-689-8054

    Webcast:                    https://bit.ly/2DciAC9

    Replays, available through August 19

    From the US:              877-481-4010

    International:               919-882-2331

    Replay Passcode:       36017

    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. 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

    Corporate: 

    Uri Yablonka

    Chief Business Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: 646-666-3188

    Investor Relations:

    Preetam Shah, MBA, PhD

    Chief Financial Officer

    BrainStorm Cell Therapeutics Inc.

    Phone: +1-862-397-1860

     

    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands

    (Except share data)









    June 30,



    December 31,



    2020



    2019



    U.S. $ in thousands

    ASSETS

    Unaudited 



    Audited









    Current Assets:







    Cash and cash equivalents

    $       12,153



    $           536

    Short-term deposit (Note 4)

    4,040



    33

    Other accounts receivable

    259



    2,359

    Prepaid expenses and other current assets (Note 5)

    176



    432

    Total current assets

    16,628



    3,360









    Long-Term Assets:







    Prepaid expenses and other long-term assets

    26



    32

    Operating lease right of use asset (Note 6)

    1,649



    2,182

    Property and Equipment, Net 

    918



    960

    Total Long-Term Assets

    2,593



    3,174









    Total assets

    $       19,221



    $       6,534

















    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)















    Current Liabilities:







    Accounts payable

    $      4,604



    $      14,677

    Accrued expenses

    2,022



    1,000

    Operating lease liability (Note 6)

    1,224



    1,263

    Other accounts payable

    990



    714

    Total current liabilities

    8,840



    17,654









    Long-Term Liabilities:







    Operating lease liability (Note 6)

    559



    1,103

    Total long-term liabilities

    559



    1,103









    Total liabilities

    $       9,399



    $       18,757









    Stockholders' Equity (deficit):







    Stock capital: (Note 7)

    12



    11

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

      June 30, 2020 and December 31, 2019 respectively; Issued and outstanding:

          29,669,855 and 23,174,228 shares at June 30, 2020

            and December 31, 2019 respectively.







    Additional paid-in-capital

    142,594



    105,042

    Receipts on account of shares

    -



    -

    Accumulated deficit

    (132,784)



    (117,276)

    Total stockholders' equity (deficit)

    9,822



    (12,223)

















    Total liabilities and stockholders' equity

    $       19,221



    $        6,534

     

     

    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

    (UNAUDITED)

    U.S. dollars in thousands

    (Except share data)















    Six months ended



    Three months ended



    June 30,



    June 30,



    2020



    2019



    2020



    2019



    Unaudited



    Unaudited

















    Operating expenses:































    Research and development, net

    $       11,642



    $       7,010



    $      5,694



    $      3,554

    General and administrative

    4,066



    2,775



    1,706



    1,303

















    Operating loss              

    (15,708)



    (9,785)



    (7,400)



    (4,857)

















    Financial expenses (income), net

    (200)



    142



    (6)



    43

















    Net loss

    $     (15,508)



    $     (9,927)



    $      (7,394)



    $      (4,900)































    Basic and diluted net loss per share

    from continuing operations   

    $   (0.56)



    $   (0.47)



    $        (0.25)



    $        (0.23)

















    Weighted average number of shares

      outstanding used in computing

      basic and diluted net loss per share

     

    27,452,750



     

    21,312,335



     

    29,274,130



     

    21,703,001



































     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-financial-results-for-the-second-quarter-of-2020-and-provides-a-corporate-update-301106481.html

    SOURCE Brainstorm Cell Therapeutics Inc

    View Full Article Hide Full Article
  19. NEW YORK, July 27, 2020 /PRNewswire/ -- BrainStorm-Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on Wednesday, August 5 2020.

     

    BrainStorm Logo

     

    On the call, BrainStorm CEO Chaim Lebovits will present a corporate update, including details on the timeline for the data readout of the Company's Phase 3 pivotal trial studying the safety and efficacy of NurOwn® (MSC-NTF cell) in people with ALS. In addition, Dr. Revital Aricha. Brainstorm's…

    NEW YORK, July 27, 2020 /PRNewswire/ -- BrainStorm-Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on Wednesday, August 5 2020.

     

    BrainStorm Logo

     

    On the call, BrainStorm CEO Chaim Lebovits will present a corporate update, including details on the timeline for the data readout of the Company's Phase 3 pivotal trial studying the safety and efficacy of NurOwn® (MSC-NTF cell) in people with ALS. In addition, Dr. Revital Aricha. Brainstorm's Vice President of Research and Development, will provide an R&D update including recently announced data from the Company's groundbreaking preclinical study evaluating NurOwn-derived exosomes for the treatment of COVID-19 ARDS.

    Thereafter, senior management officers will join the call for a Q&A session. Participants are encouraged to submit their questions prior to the call by sending them to: . Questions should be submitted by 5:00 p.m. EDT, Monday, August 3, 2020. 

    Teleconference Details – BRAINSTORM CELL THERAPEUTICS 2Q 2020

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

    Participant Numbers:

    Toll Free: 877-407-9205

    International: 201-689-8054

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

    Event Link:

    Webcast URL:

    https://bit.ly/2DciAC9

    Webcast Replay Expiration:

    Thursday, August 05, 2021

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

    Replay Number:

    Toll Free: 877-481-4010

    International: 919-882-2331

    Replay Passcode: 36017

    Teleconference Replay Expiration:

    Wednesday, August 19, 2020

    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-cell-therapeutics-to-announce-second-quarter-financial-results-and-provide-a-corporate-and-rd-update-301100141.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  20. Intratracheal administration of exosomes extracted from MSC's using NurOwn® technology resulted in statistically significant improvement in multiple lung parameters in a mouse model

    BrainStorm will discuss results during Q2 corporate earnings call on Wednesday August 5

    NEW YORK, July 23, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it has successfully completed its first milestone in developing an innovative exosome-based platform-technology for the treatment severe COVID-19 infection.

    COVID-19 induced pneumonia carries a high fatality rate and has been associated with acute respiratory distress syndrome…

    Intratracheal administration of exosomes extracted from MSC's using NurOwn® technology resulted in statistically significant improvement in multiple lung parameters in a mouse model

    BrainStorm will discuss results during Q2 corporate earnings call on Wednesday August 5

    NEW YORK, July 23, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that it has successfully completed its first milestone in developing an innovative exosome-based platform-technology for the treatment severe COVID-19 infection.

    COVID-19 induced pneumonia carries a high fatality rate and has been associated with acute respiratory distress syndrome (ARDS). Currently, there is no effective treatment strategy to prevent or reverse ARDS, a type of respiratory failure associated with widespread inflammation and lung damage mediated by dysregulated cytokine production.



    Exosomes are nano-sized (30–150 nm) vesicles secreted by all cell types. Mesenchymal stem cells (MSC) derived exosomes have been suggested as a potential treatment for ARDS due to their ability to penetrate into deep tissues, effectively deliver bioactive molecules to target cells and mitigate the inflammatory response. MSC exosomes may be delivered intravenously or directly into the lung via intratracheal administration.



    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 most importantly, attenuation of lung damage. Moreover, MSC-NTF cell derived exosomes exhibited a superior effect when compared to treatment with exosomes derived from naïve mesenchymal stem cells (MSC) from the same donor. BrainStorm intends to accelerate submission of these important results to peer-reviewed medical journals. 

    The preclinical experiment demonstrated a statistically significant reduction in lung disease severity score (p=0.03) (based on the American Thoracic Society Documents, 2011; Matute-Bello et al., Am J Respir Cell Mol Biol 44;725-738, 2011) and vastly improved lung histology following intratracheal administration of NurOwn (MSC-NTF) exosomes compared to MSC exosomes.

    A graph accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/224bd3d0-90a3-4850-8b56-854d808c6386

    An image accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e5276300-106b-4a35-9ef5-7d8907561db9

    To-date, BrainStorm Cell Therapeutics has focused its clinical development on the application of the NurOwn technology platform to neurodegenerative disorders. Given these important pre-clinical results, the Company will revisit its strategy to determine if and when to proceed with a clinical trial in ARDS. 

    Dr. Revital Aricha, VP of Research & Development at BrainStorm, will discuss the results on the company's second quarter 2020 earnings call and corporate update, scheduled for Wednesday August 5th, at 8.00am ET.

    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.

    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 is also conducting a U.S. FDA approved 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

    Primary Logo

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  21. NEW YORK, July 8, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, is hosting a Key Opinion Leader (KOL) webinar on its Alzheimer's Disease (AD) program today at 8:15 AM Eastern Time. The Company recently announced that it is expanding its clinical pipeline to develop NurOwn® and begin a Phase 2 study in AD.

    The webinar features presentations by two lead investigators in the Company's planned international Phase 2 trial: 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 other clinical trial sites in the Netherlands and France.

    To participate in the webcast, please use the link below and to view a copy of the accompanying slide presentation, please refer to the Events & Presentations section of the Company's website. The presentation will be followed by a question-and-answer session with Professors Scheltens and Dubois and with BrainStorm management. 

    Register and access live webinar here

    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.

    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.

    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 to download multimedia:http://www.prnewswire.com/news-releases/brainstorm-hosting-kol-webinar-to-discuss-nurown-phase-2-alzheimers-disease-program-301089905.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  22. 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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  23. 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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  24. 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

     

     

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    SOURCE Brainstorm Cell Therapeutics Inc

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  25. 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

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    SOURCE Brainstorm Cell Therapeutics Inc

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  26. 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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  27. NEW YORK, June 11, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Chaim Lebovits, CEO and Ralph Kern, MD, MHSc, President and Chief Medical Officer, will present a corporate overview on Thursday, June 18 at 9:00 am EST, during the Raymond James Human Health Innovations Conference, a virtual event connecting institutional investors with company management teams that will be held June 15-18, 2020. 

    BrainStorm Logo

    Mr. Lebovits and Dr. Kern will update conference participants on the Company's investigational therapeutic, NurOwn®, that is currently in a fully enrolled phase 3 study for the treatment of ALS and a phase 2 study for the treatment…

    NEW YORK, June 11, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Chaim Lebovits, CEO and Ralph Kern, MD, MHSc, President and Chief Medical Officer, will present a corporate overview on Thursday, June 18 at 9:00 am EST, during the Raymond James Human Health Innovations Conference, a virtual event connecting institutional investors with company management teams that will be held June 15-18, 2020. 

    BrainStorm Logo

    Mr. Lebovits and Dr. Kern will update conference participants on the Company's investigational therapeutic, NurOwn®, that is currently in a fully enrolled phase 3 study for the treatment of ALS and a phase 2 study for the treatment of progressive multiple sclerosis. Additionally, they will present an overview of the Company's financial position and pipeline. After the presentation, the management team will participate in a question and answer session with institutional investors.

    Mr. Lebovits and Dr. Kern will be joined by David Setboun, PhD, MBA, Chief Operating Officer, Stacy Lindborg, PhD, Head of Global Clinical Research, and Preetam Shah, PhD, MBA, Chief Financial Officer, for a series of one-on-one meetings, with select institutional investors arranged by Raymond James.

    Participants can view the presentation via the event link and those unable to join will have access to an archived link on the Company's Events and Presentation webpage after the conclusion of the conference. 

    EVENT: Raymond James Human Health Innovations Conference

    PRESENTATION: Thursday, June 18th at 9:00 am EST

    LINK: https://bit.ly/2YmZf8u 

    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

     

     

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  28. WASHINGTON, June 9, 2020 /PRNewswire/ -- The ALS Association and I AM ALS announced today that the organizations have awarded a combined grant of $500,000 to BrainStorm Cell Therapeutics (NASDAQ:BCLI), a biotechnology company, to support an amyotrophic lateral sclerosis (ALS) biomarker research study. The grant will be used to draw insights from data and samples collected from patients enrolled in BrainStorm's ongoing phase 3 clinical trial of its NurOwn® treatment, to further understanding of critical biomarkers associated with treatment response for people with ALS.

    BrainStorm_Logo

    The study is designed to evaluate how NurOwn interacts with its targets in the brain and spinal cord and to explore the changes in the biomarkers that may correlate with response…

    WASHINGTON, June 9, 2020 /PRNewswire/ -- The ALS Association and I AM ALS announced today that the organizations have awarded a combined grant of $500,000 to BrainStorm Cell Therapeutics (NASDAQ:BCLI), a biotechnology company, to support an amyotrophic lateral sclerosis (ALS) biomarker research study. The grant will be used to draw insights from data and samples collected from patients enrolled in BrainStorm's ongoing phase 3 clinical trial of its NurOwn® treatment, to further understanding of critical biomarkers associated with treatment response for people with ALS.

    BrainStorm_Logo

    The study is designed to evaluate how NurOwn interacts with its targets in the brain and spinal cord and to explore the changes in the biomarkers that may correlate with response to the drug treatment. Biomarkers are any measurable substance in the body that change over time (such as cholesterol or blood pressure) and that correlate with disease processes or treatment response. If successful, this study will help confirm that the ALS treatment NurOwn works in the way it is intended and will help inform our larger understanding of ALS biomarkers. 

    "This grant to BrainStorm marks an important step forward in establishing how exactly NurOwn works in the body," said Calaneet Balas, President and CEO of The ALS Association. "This research is also important to our overall pursuit of identification and validation of ALS biomarkers. We hope NurOwn is ultimately proven effective in treating ALS and we stand ready to support BrainStorm in its plan to apply for a biologics license for NurOwn."

    Danielle Carnival, CEO of I AM ALS commented, "We need to move with urgency in all of our efforts to deliver treatments and cures for ALS. This biomarker research will help us more expeditiously understand the effectiveness of NurOwn, while possibly unlocking discoveries that provide clues for other promising treatments. We are at a pivotal time for ALS research in pursuit of treatment solutions and will do whatever we can, together, to drive new answers and new hope for patients."

    The joint award to BrainStorm consists of a $400,000 grant from The ALS Association and a $100,000 grant from I AM ALS. As part of this agreement, BrainStorm has agreed to share data and samples with the ALS community so that the results can be independently validated and to advance other ALS research.

    Chaim Lebovits, CEO of BrainStorm stated, "We sincerely appreciate the scientific recognition and generous support from The ALS Association and I AM ALS and we are excited through this study to further an already strong partnership between The ALS Association, I AM ALS and Brainstorm. This critical research study involves one of the largest and most robust clinical trial collections of CSF biomarkers. Data generated from this study will increase our understanding of how NurOwn® therapy impacts ALS disease progression and may identify patients who benefit the most from this form of therapy. We also hope that this research study will benefit the broader ALS scientific community as we collectively advance towards our shared goal of delivering much needed treatments."

     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 The ALS Association

    The ALS Association is the largest private funder of ALS research in the world. The Association funds global research collaborations, provides assistance for people with ALS and their families through our nationwide network of chapters and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association builds hope and enhances quality of life while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.als.org.

    About I AM ALS

    Founded in 2019 by husband-wife team Brian Wallach and Sandra Abrevaya, I AM ALS was born out of their desire to change the future for Brian and the thousands of other ALS patients in the world. I AM ALS brings together patients, advocates, organizations and scientists to deliver critical and innovative resources for patients, empower and mobilize patients and their networks to lead the fight for cures, and transform the public understanding of ALS with a goal of flooding the research pipeline with new, lifesaving drugs. A cure is possible ... if we work together to re-imagine the fight against ALS. Learn more here: www.iamals.org.

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

    About ALS

    ALS is a disease that attacks cells in the body that control movement. It makes the brain stop talking to the muscles, causing increased paralysis over time. Ultimately, ALS patients become prisoners within their own bodies, unable to eat, breathe, or move on their own. Their mind, however, often remains sharp so they are aware of what's happening to them.

    Contact: Brian Frederick

    The ALS Association

    (202) 464-8612

     

    Contact: Kathleen Rooney

    I AM ALS

    (312) 529-0391

     

     

     

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  29. NEW YORK, June 3, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Dr. Ralph Kern, M.D, President and Chief Medical Officer will present a corporate overview during the BIO International Convention, which has transitioned to a new and virtual event and has been renamed BIO Digital. During BIO Digital, Dr. Kern will update conference participants on the Company's investigational therapeutic NurOwn® that is currently in a phase 3 study for the treatment of ALS and a phase 2 study for the treatment of progressive multiple sclerosis, and present an overview of the Company's pipeline. Additionally, Mr. Chaim Lebovits, CEO of BrainStorm…

    NEW YORK, June 3, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced Dr. Ralph Kern, M.D, President and Chief Medical Officer will present a corporate overview during the BIO International Convention, which has transitioned to a new and virtual event and has been renamed BIO Digital. During BIO Digital, Dr. Kern will update conference participants on the Company's investigational therapeutic NurOwn® that is currently in a phase 3 study for the treatment of ALS and a phase 2 study for the treatment of progressive multiple sclerosis, and present an overview of the Company's pipeline. Additionally, Mr. Chaim Lebovits, CEO of BrainStorm, and other members of the BrainStorm management team will participate in one-on-one digital partnering meetings, which registered conference participants can request by utilizing the BIO Partnering link provided by conference organizers.

    Event:                                                        

    BIO Digital 2020

    Place:                                                         

    https://www.bio.org/events/bio-digital/registration

    Presentation Date:                                      

    June 8-12, 2020

    Link to BrainStorm's Presentation: 

    https://www.bio.org/events/bio-digital/sessions/680253

    Link to BIO Partnering:                              

    https://www.bio.org/events/bio-digital/partnering

     

    BrainStorm Logo

     

    About BIO 

    BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

    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. 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:

    Sean Leous
    Westwicke/ICR PR
    Phone: +1-646-677-1839
     

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-to-participate-in-bio-digital-2020-301069948.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  30. NEW YORK, June 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today an update on the Company's Phase 3 pivotal trial investigating NurOwn® in ALS. The Company continues to expect that top-line data from the trial will be announced by Q4-2020, despite the ongoing COVID-19 pandemic that has delayed hundreds of other clinical trials around the world.

    BrainStorm Logo

    Due to the importance of the clinical trial and the recognized high unmet need in ALS, Brainstorm and the 6 prestigious U.S. clinical sites have been able to continue treatment visits throughout the COVID-19 pandemic with only occasional scheduling changes to treatments. The decision…

    NEW YORK, June 2, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today an update on the Company's Phase 3 pivotal trial investigating NurOwn® in ALS. The Company continues to expect that top-line data from the trial will be announced by Q4-2020, despite the ongoing COVID-19 pandemic that has delayed hundreds of other clinical trials around the world.

    BrainStorm Logo

    Due to the importance of the clinical trial and the recognized high unmet need in ALS, Brainstorm and the 6 prestigious U.S. clinical sites have been able to continue treatment visits throughout the COVID-19 pandemic with only occasional scheduling changes to treatments. The decision to continue the trial is also shared by the ALS community and the FDA. The clinical trial sites are at University of California, Irvine; Cedars-Sinai Medical Center; California Pacific Medical Center; Massachusetts General Hospital; University of Massachusetts Medical School and Mayo Clinic. Importantly, the trial's primary outcome measurement (the ALSFRS-R rating scale) is fully validated for telephonic administration, which allowed non-treatment visits to be conducted remotely and to be aligned with protocol assessment timelines. This allows for ongoing high-quality data collection while prioritizing safety of patients and clinical trial site staff.

    "Despite the challenges presented by COVID-19, patient dosing remains on track with all participants having received at least 2 treatments of NurOwn®," said Dr. Merit Cudkowicz, the Julieanne Dorn Professor of Neurology at Harvard Medical School and the Director of the Healey Center for ALS and Chair of Neurology at Mass General Hospital. "Moving forward, only 20 patients are still to be dosed for the third and final time, and these final treatments remain on schedule."

    Chaim Lebovits, CEO of BrainStorm stated, "BrainStorm made the decision to continue our Phase 3 trial and we have been strongly supported by our partners in the clinical community.  Quick planning and coordination across our clinical sites and the support and direction of the U.S. FDA enabled our Phase 3 investigational trial for NurOwn to advance, with final dosing by July 2020. While numerous clinical trials in the U.S. have been interrupted or completely shut down by the COVID-19 pandemic, trial participants, their families, and the investigational teams remain committed to the trial's advancement. I am extremely proud and grateful for the outstanding work and commitment of so many, and particularly by these trial participants and their caregivers. We hope to soon reward their commitment by bringing forward a much-needed treatment for ALS."

    Ralph Kern, MD, MHSc, BrainStorm's President and Chief Medical Officer said, "We are very fortunate to have developed an outstanding team of partners who are committed to BrainStorm's investigational therapy NurOwn and share its promise in ALS research. Our primary concerns will always be the overall health and safety of trial participants and the scientific integrity of the trial. Fortunately, ALSFRS-R, the primary outcome measurement of the Phase 3 trial, is validated by phone and allows for the collection of quality data with minimal risk of COVID-19 exposure. This, along with the collective efforts of so many of our employees, partners, and patients, has enabled us to remain on track for study completion as planned in the fourth quarter of this year." 

    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. 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:

    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Cision View original content:http://www.prnewswire.com/news-releases/brainstorm-announces-that-pivotal-phase-3-trial-remains-on-track-for-topline-data-in-q4-2020-301069123.html

    SOURCE Brainstorm Cell Therapeutics Inc

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  31. Conference Call and Webcast Today at 8:30 a.m. Eastern Time

    ALS Phase 3 Clinical Trial Remains on Track for Q4'20 Top-line Data Readout

    NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the first quarter ended March 31, 2020 and recent corporate updates.

    "While many companies have been greatly hindered by the COVID-19 pandemic, Brainstorm, due to the incredible strength of our clinical trial participants, the amazing teams at our U.S. investigational sites and the talent and commitment of each and every team member at BrainStorm, the Phase 3 ALS trial remains on track for a Q4'20 topline…

    Conference Call and Webcast Today at 8:30 a.m. Eastern Time

    ALS Phase 3 Clinical Trial Remains on Track for Q4'20 Top-line Data Readout

    NEW YORK, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the first quarter ended March 31, 2020 and recent corporate updates.

    "While many companies have been greatly hindered by the COVID-19 pandemic, Brainstorm, due to the incredible strength of our clinical trial participants, the amazing teams at our U.S. investigational sites and the talent and commitment of each and every team member at BrainStorm, the Phase 3 ALS trial remains on track for a Q4'20 topline data readout.  Participants in the fully enrolled clinical trial in our 6 United States medical centers of excellence continue to receive their scheduled treatments with the necessary safety protocols in place," stated Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. He added, "We were able to advance our global footprint by signing an agreement with a senior, leading EMEA (European Medicines Agency) regulatory consultant who will advise us as we approach EMEA Regulatory Institutions to present data for NurOwn in ALS, and the advancement of NurOwn in other disease indications. Additionally, we entered into a lease agreement with the Tel Aviv Sourasky Medical Center (Ichilov Hospital) in Tel Aviv, Israel, to produce NurOwn in three state-of-the-art cleanrooms. The new facility will significantly increase the Company's manufacturing capacity, allowing us to strategically enter the European and Israeli markets." 

    Dr. Ralph Kern, President and Chief Medical Officer of Brainstorm Cell Therapeutics said, "The COVID-19 pandemic has resulted in delays in the pace of enrollment for our Phase 2 Progressive MS clinical trial. Scheduled March and April 2020 new participant enrollments were deferred to May 2020 when the affected healthcare sites anticipate their access restrictions may be mitigated. We anticipate that enrollment will continue in 2020 subject to any site access restrictions related to COVID-19. Additionally, we are collecting clinical and biomarker data from the treated progressive MS participants and plan to perform an interim analysis after 50% of participants in the trial have been treated. Our clinical team has maximized this disruptive time to re-examine our data and make sure our data is pristine for future regulatory submissions." Dr. Kern concluded, "In terms of the Hospital Exemption Program, the Company has not completed treatment of all the first 13 patients as non-Israeli patients are unable to travel to Israel at the present time due to COVID-19 travel restrictions. The Company is currently collecting HE clinical data for the patients who already received treatment at the Tel Aviv Sourasky Medical Center. Once the complete data set for the first 13 treated patients is available, we will perform a detailed analysis."

    First Quarter 2020 and Recent Corporate Highlights:

    • April 3: Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority 
    • April 1: Appoints David Setboun as COO; Dr. Ralph Kern promoted to President
    • March 31: Appoints distinguished economist Dr. Jacob Frenkel as chairman of the board; appoints Mr. Sankesh Abbhi, a seasoned executive and entrepreneur in life sciences as new board member
    • March 16: Announced receipt of $2.2 million from CIRM for meeting prespecified milestones
    • March 6: Raised gross proceeds of $10 million financing from Abbhi Investments, LLC in a registered direct offering
    • March 6: Enters common stock ATM distribution agreement for up to $50 million with Raymond James
    • February 11: Announced that the Company and FDA agreed to potential NurOwn® regulatory pathway for approval in ALS and committed to work collaboratively, including opportunities to expedite statistical review of data from the Phase 3 trial.

    Scientific and Company Presentations:

    • February 17 - Presentation at Noble Capital Markets' Sixteenth Annual Investor Conference
    • February 11 - Presentation at BIO CEO & Investor Conference
    • January 24 - Podium presentation at the 10th Annual California ALS Research Summit
    • January 12 - Presentation and participation at the Rare & Orphan Diseases Panel at the 3rd Annual Neuroscience Innovation Forum

    Financial Results for the Three Months Ended March 31, 2020

    • Cash, cash equivalents, and short-term bank deposits were approximately $14.5 million at March 31, 2020, compared to $6.2 million at March 31, 2019.
    • Research and development expenses, net, for the three months ended March 31, 2020 were $5.95 million, compared to $3.46 million, net for the three months ended March 31, 2019.
      - Excluding participation from IIA and CIRM under the grants and proceeds received under the Hospital Exemption regulatory pathway, research and development expenses increased by $1.94 million from $5.20 million in the first quarter of 2019 to $7.14 million in the first quarter of 2020
    • General and administrative expenses for the three months ended March 31, 2020 were $2.36 million, compared to $1.47 million in the three months ended March 31, 2019.
    • Net loss for the three months ended March 31, 2020 was $8.1 million, or ($0.32) per share, as compared to a net loss of $5.03 million, or ($0.24) per share for the three months ended March 31, 2019.

    For further details on BrainStorm's financials, including financial results for the three months ended March 31, 2020, refer to Form 10-Q filed with the SEC on May 7th, 2020

    Conference Call and Webcast: Thursday, May 7, 2020 @ 8:30 a.m. Eastern Time

    U.S. Toll Free: 877-407-9205
       
    Toll/International: 201-689-8054
       
    Webcast Link: https://www.webcaster4.com/Webcast/Page/2354/34588

    A teleconference replay of the conference call will be available for 14 days on the "Investors & Media" page of BrainStorm's website:

    Toll Free: 877-481-4010
       
    Toll/International: 919-882-2331
       
    Replay Passcode: 34588
       
    Teleconference Replay Expiration: Thursday, May 21, 2020

    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. 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

    Corporate: 
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    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


    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

    INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands
    (Except share data)

       
        March 31,     December 31,  
        2 0 2 0     2 0 1 9  
       
    U.S. $ in thousands
     
    ASSETS    Unaudited     Audited   
         
    Current Assets:    
    Cash and cash equivalents $ 12,471   $ 536  
    Short-term deposit (Note 4)   2,020     33  
    Other accounts receivable   435     2,359  
    Prepaid expenses and other current assets (Note 5)   279     432  
    Total current assets   15,205     3,360  
         
    Long-Term Assets:    
    Prepaid expenses and other long-term assets   31     32  
    Operating lease right of use asset (Note 6)   1,917     2,182  
    Property and Equipment, Net   918     960  
    Total Long-Term Assets   2,866     3,174  
                 
         
    Total assets $ 18,071   $ 6,534  
                 
         
    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)    
         
    Current Liabilities:    
    Accounts payable $ 4,571   $ 14,677  
    Accrued expenses   1,303     1,000  
    Operating lease liability (Note 6)   1,208     1,263  
    Other accounts payable   1,170     714  
    Total current liabilities   8,252     17,654  
                 
    Long-Term Liabilities:    
    Operating lease liability (Note 6)   808     1,103  
    Total long-term liabilities   808     1,103  
                 
    Total liabilities $ 9,060   $ 18,757  
         
    Stockholders' Equity (deficit):    
    Stock capital: (Note 7)   12     11  
    Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at
       March 31, 2020 and December 31, 2019 respectively; Issued and outstanding:
          28,423,837 and 23,174,228 shares at March 31, 2020
             and December 31, 2019 respectively.
       
    Additional paid-in-capital   134,389     105,042  
    Receipts on account of shares   -     -  
    Accumulated deficit   (125,390)     (117,276)  
    Total stockholders' equity (deficit)   9,011     (12,223)  
                 
         
    Total liabilities and stockholders' equity $ 18,071   $ 6,534  
                 


    BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES

     INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
    U.S. dollars in thousands

    (Except share data)

      Three months ended
      March 31,
        2 0 2 0     2 0 1 9
       U.S. $ in thousands
             
    Operating expenses:          
               
    Research and development, net $   5,948   $   3,456
    General and administrative   2,360     1,472
               
    Operating loss   (8,308)     (4,928)
         
    Financial expenses (income), net   (194)     99
               
    Net loss $   (8,114)   $    (5,027)
    Basic and diluted net loss per share from continuing operations  $   (0.32)   $   (0.24)
                 
    Weighted average number of shares outstanding used in computing basic and diluted net loss per share   28,423,837     20,917,329
               

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  32. NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center ("Sourasky) in Tel Aviv, Israel, to produce NurOwn® in three state-of-the-art cleanrooms. The new facility will significantly increase the Company's capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Sourasky's Institute for Advanced Cellular Therapies.

    "Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale…

    NEW YORK, N.Y., and TEL AVIV, Israel, May 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today a lease agreement with the Tel Aviv Sourasky Medical Center ("Sourasky) in Tel Aviv, Israel, to produce NurOwn® in three state-of-the-art cleanrooms. The new facility will significantly increase the Company's capacity to manufacture and ship its product into the European Union and the local Israeli market. The cleanroom facility is part of Sourasky's Institute for Advanced Cellular Therapies.

    "Sourasky Hospital is a leader in the advancement and manufacturing of cell and gene therapy products and is well-equipped to rapidly scale up and produce NurOwn," stated Prof. Ronni Gamzu, CEO of Tel Aviv Sourasky Medical Center. "We look forward to continuing our work with BrainStorm to bring NurOwn to ALS patients and help fulfill the clinical therapy demands for the Company's pipeline programs."

    "Sourasky Hospital, known for introducing pioneering solutions into clinical practice and advancing patient care, has a first rate team with the proven experience to produce regenerative products in accordance to the highest standard of cGMP manufacturing," said Chaim Lebovits, CEO of BrainStorm.  "This agreement will ensure that we can provide NurOwn to patients after regulatory approval, not only in Israel but we have secured capacity to rapidly scale up production as we advance our investigational treatment across the European Union. We are very pleased to be able to expand our ongoing collaboration with Sourasky Hospital, one of the world's most innovative and respected medical centers."

    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. 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:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

     

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  33. NEW YORK, May 04, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that new data highlighting the immunomodulatory effects of NurOwn® on B and T regulatory function appeared in an online supplement to Neurology.

    The abstract was originally planned for presentation at the recently cancelled 2020 American Academy of Neurology (AAN) annual meeting. In addition to the online supplement, the abstract is also available through the AAN online abstracts website.

    "Neuroinflammation is a prominent pathological feature of ALS and progressive MS. Reduced T and B regulatory function may contribute to disease progression, and lower…

    NEW YORK, May 04, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that new data highlighting the immunomodulatory effects of NurOwn® on B and T regulatory function appeared in an online supplement to Neurology.

    The abstract was originally planned for presentation at the recently cancelled 2020 American Academy of Neurology (AAN) annual meeting. In addition to the online supplement, the abstract is also available through the AAN online abstracts website.

    "Neuroinflammation is a prominent pathological feature of ALS and progressive MS. Reduced T and B regulatory function may contribute to disease progression, and lower IL-10 levels may be associated with reduced ALS function and with higher disability and MRI lesion load in secondary progressive MS," said Ralph Kern MD, MHSc, President and Chief Medical Officer of Brainstorm, "The immunomodulatory properties of MSC-NTF cells, including their effects on T and B regulatory cells, and the observed increase in IL-10 secretion, may be an important contributor to the potential therapeutic benefits of NurOwn in ALS and progressive MS."

    "Brainstorm is committed to fully developing NurOwn technology while continuing to expand our understanding of potential biological mechanisms of action that may contribute to its therapeutic effects in neurodegenerative diseases," said Chaim Lebovits, Brainstorm CEO, "We look forward to advance our technology platform across several neurodegenerative disease indications and bring much-needed solutions to patients."

    Brainstorm AAN 2020 abstract:
    MSC-NTF Cell Immunomodulation: Effects on T and B Regulatory Cells
    Revital Aricha, Natalie Abramov, Jonathan Semo, Haggai Kaspi, Chaim Lebovits, Ralph Kern.

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    View Full Article Hide Full Article
  34. NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA).  The grant enables Brainstorm to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes as a novel therapeutic platform, and will ultimately enable Brainstorm to expand the therapeutic pipeline in neurodegenerative disorders.

    BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's…

    NEW YORK and PETACH TIKVAH, Israel, April 03, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announced that its wholly-owned subsidiary, Brainstorm Cell Therapeutics Ltd., has been awarded a new grant of approximately $1.5 million by the Israel Innovation Authority (IIA).  The grant enables Brainstorm to continue development of advanced cellular manufacturing capabilities, furthers development of MSC-derived exosomes as a novel therapeutic platform, and will ultimately enable Brainstorm to expand the therapeutic pipeline in neurodegenerative disorders.

    BrainStorm's CEO Chaim Lebovits, commented, "The Israel Innovation Authority's support of our programs provides further validation for the potential of our treatments to help patients suffering from neurodegenerative disorders. The continued financial support for our research and development will further our ability to execute our strategic objectives, as we finalize our Phase 3 pivotal trial with NurOwn in ALS patients and advance our cellular technology pipeline."

    The IIA has supported BrainStorm Cell Therapeutics Ltd. since 2007, providing grants totaling approximately 11.4 million USD in support of the development of NurOwn and other projects. BrainStorm will be required to pay mid-single digit royalties to the IIA based on sales of the products, up to a total of the cumulative amount of IIA grants received plus accumulated interest.

    About NurOwn®
    NurOwn (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    View Full Article Hide Full Article
  35. International Pharmaceutical Veteran to Lead Global Business and Commercial Development

    Ralph Kern, MD, MHSc, Promoted to President

    NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that David Setboun, Pharm.D., MBA, has been appointed Executive Vice President and Chief Operating Officer.

    International pharmaceutical executive Dr. Setboun, has directed commercial development, business strategy, and product launches for 2 decades at 3 major biopharmaceutical companies. Most recently, Dr. Setboun served as VP Corporate Development, Strategy & Business at Life Biosciences. In this role, David was instrumental…

    International Pharmaceutical Veteran to Lead Global Business and Commercial Development

    Ralph Kern, MD, MHSc, Promoted to President

    NEW YORK, April 01, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that David Setboun, Pharm.D., MBA, has been appointed Executive Vice President and Chief Operating Officer.

    International pharmaceutical executive Dr. Setboun, has directed commercial development, business strategy, and product launches for 2 decades at 3 major biopharmaceutical companies. Most recently, Dr. Setboun served as VP Corporate Development, Strategy & Business at Life Biosciences. In this role, David was instrumental in the development of various critical commercial, operating and funding milestones. From June 2015 to June 2018, he served as President, Biogen, France where he launched Biogen's rare disease franchise. In addition, he supervised the launch of key neurology products and oversaw the Biosimilar business unit. Prior to his tenure at Biogen, Dr. Setboun, served as President, AstraZeneca, Portugal from 2012 to 2015, where he managed a product portfolio that grossed over $200 million annually. Prior to this role, David led the European Sales & Marketing function as AstraZeneca's VP Europe where he directed a team of executives in marketing, commercial excellence, pricing and market access. During his tenure, he expanded AstraZeneca's Oncology, Diabetes and Cardiovascular franchises. From 2002 to 2009, Dr. Setboun directed national and international teams and projects for Eli Lilly and Company in France and the USA. Fluent in French, English, Spanish and Portuguese, Dr. Setboun received his Pharmaceutical Doctorate (Pharm.D.) from University Paris XI in 1997 and his MBA from H.E.C Paris in 2001. More recently, David graduated from Harvard Business School (AMP 194).

    "BrainStorm's investigational therapy, NurOwn® is an amazing technology platform that has the potential to bring treatment to those with ALS and progressive MS and other neurodegenerative indications. With a fully enrolled Phase 3 Pivotal Trial for ALS in place, a Phase 2 Trial for progressive MS, an investigational platform in exosomes and the most ambitious biomarker program in ALS, I know I am joining a company with outstanding potential," said Dr. Setboun.

    "David's experience launching products for international biopharmaceutical companies and his expertise in commercial, business development and investments, make him an outstanding new member of the BrainStorm leadership team. His extensive experience at all levels of sales and marketing, coupled with his business strategy experience comes to us at a critical time in the evolution of NurOwn® and helps us achieve our goal of bringing new treatment options to patients afflicted with neurodegenerative diseases, including ALS and progressive MS," said Chaim Lebovits, Chief Executive Officer of BrainStorm.

    "Additionally, I am very pleased to announce Ralph Kern MD, MHSc, has been promoted to President of BrainStorm. Ralph joined BrainStorm in March 2017 as Chief Operating Officer and Chief Medical Officer.  Directing our clinical development, Ralph has helped the Company rapidly achieve clinical milestone, after clinical milestone, while guiding the Company to expand its product pipeline to investigate additional applications and disease indications. In recognition of his ongoing, outstanding service, Ralph has been elevated to the position of President and Chief Medical Officer of BrainStorm."    

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    View Full Article Hide Full Article
  36. NEW YORK, March 31, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cell technologies for neurodegenerative diseases, today announced the appointment of Jacob Frenkel, Ph.D., as Chairman of the Board of Directors. Prof. Frenkel, a world-renowned economist and former Governor of the Bank of Israel, will join the Company at its most significant turning point as it completes its phase 3 ALS clinical trial and submits clinical trial data for regulatory review and publication later this year. Prof. Frenkel will support the Company's global business development and partnership expansion.  Dr. Irit Arbel, one of BrainStorm's co-founders, will serve as Vice Chair of the Board. Additionally, Sankesh…

    NEW YORK, March 31, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of cell technologies for neurodegenerative diseases, today announced the appointment of Jacob Frenkel, Ph.D., as Chairman of the Board of Directors. Prof. Frenkel, a world-renowned economist and former Governor of the Bank of Israel, will join the Company at its most significant turning point as it completes its phase 3 ALS clinical trial and submits clinical trial data for regulatory review and publication later this year. Prof. Frenkel will support the Company's global business development and partnership expansion.  Dr. Irit Arbel, one of BrainStorm's co-founders, will serve as Vice Chair of the Board. Additionally, Sankesh Abbhi, a successful healthcare entrepreneur, executive and investor, also joins the Board.  Mr. Abbhi will replace Mr. Chen Schor on the Board.

    "Prof. Frenkel is joining our Board as Chairman at a crucial time where his leadership will add tremendous value," stated Chaim Lebovits, President and CEO of BrainStorm. "Prof. Frenkel served on BrainStorm's advisory board about a decade ago. Since that time, BrainStorm has demonstrated its ability to develop and deliver innovative stem cell treatments through the highly challenging path from the pre-clinical laboratory to phase 3 trials. Mr. Abbhi feels passionately about improving the lives of patients and families affected by neurodegenerative disease. His previously announced strategic financial support combined with his leadership as Director will help BrainStorm pursuing its mission to bring life-changing treatments to those impacted by ALS and MS.  We are grateful to Dr. Arbel who will continue to serve as Vice Chair of the Board. We also thank Mr. Chen Schor for his decade long service and significant contribution to BrainStorm."

    Prof. Frenkel said, "I am honored to join BrainStorm as Chairman of the Board of Directors. The Company has advanced the investigational therapy NurOwn® into a fully enrolled phase 3 clinical trial for ALS — a critical juncture in its history." He added, "Chaim Lebovits has built an impressive team and has led the Company with great commitment and inspiration. I look forward to joining by leading the Board and supporting BrainStorm's global expansion and partnership strategy."

    Jacob Frenkel, Ph.D., currently serves as Chairman of the Board of Trustees of the Group of Thirty (G-30), a private, nonprofit, consultative group on international economic and monetary affairs. During 2001-11 he served as Chairman and chief executive officer of the G-30. Previously, Prof. Frenkel served as Chairman of JPMorgan Chase International (2009-2020), from 2009 to 2020, as Vice Chairman of American International Group, Inc. (AIG) (2004-9), and as Chairman of Merrill Lynch International (2000-2004).

    Between 1991 and 2000 he served two terms as the Governor of the Bank of Israel, Previously he was the Economic Counselor and Director of Research at the International Monetary Fund (1987-91), and also served on the faculty of the University of Chicago, where he held the position of the David Rockefeller Professor of International Economics as well as serving as Editor of the Journal of Political Economy (1973-87).

    Prof. Frenkel is a Fellow of the Econometric Society, a lifetime Fellow of the International Economic Association, a Foreign Honorary Member of the American Academy of Arts and Sciences, a member of the Boards of Directors of the National Bureau of Economic Research, the Institute for National Security Studies (INSS), the Japan Society, and the Peterson Institute for International Economics. He is a member of the Competitive Markets Advisory Council (CMAC) of the CME Group, the Boards of the Aspen Institute Italia and The Council for the US and Italy, a member emeritus of Temasek International Panel (TIP), a Senior Advisor of Temasek International Advisors, a member of the G20 Eminent Persons Group (EPG) on Global Financial Governance, a member of the International Advisory Council of China Development Bank, and a Global Member of the Trilateral Commission.

    Prof. Frenkel is a Laureate of the 2002 Israel Prize in Economics, a recipient of the Scopus Award from the Hebrew University, the Hugo Ramniceanu Prize for Economics from the Tel-Aviv University, the Czech Republic's Karel English Prize in Economics, the "Order de Mayo al Merito" (in the rank of Gran Cruz) decoration from the Government of Argentina, the "Order of Merit" (in the rank of Cavaliere di Gran Croce) decoration from the Republic of Italy, and the YIVO Lifetime Achievement Award. 

    He serves as Chairman of the Board of Governors of Tel Aviv University, where he is also Chairman of the Frenkel-Zuckerman Institute for Global Economics. He previously served as Chairman of the Board of Governors of the Inter-American Development Bank (1995-1996), as Vice Chairman of the Board of Governors of the European Bank for Reconstruction and Development (1999-2000), as Governor of the IMF and Alternate Governor of the World Bank for Israel (1991-2000), a member of the Economic Advisory Panel of the Federal Reserve Bank of New York (1986-2014), and a member of the Board of Trustees of the New York Economic Club (2013-2019).

    Prof. Frenkel is the author of numerous books and articles in the fields of International Economics and Macroeconomics and is a recipient of several Honorary Doctoral degrees and other decorations and awards. He earned a B.A. in economics and political science at the Hebrew University of Jerusalem and an M.A. and Ph.D. in economics at the University of Chicago. 

    Sankesh Abbhi is the President and CEO of ArisGlobal, a leading provider of cloud-based, end-to-end, drug development technology solutions for over 250 of the world's leading Life Science's companies, CROs and government health authorities. Mr. Abbhi, also advises Abbhi Capital, his wholly owned family office, in its corporate investments in transformative life sciences, healthcare and technology companies. Prior to leading ArisGlobal and Abbhi Capital, Mr. Abbhi founded Synowledge, a knowledge process outsourcing company which he grew to over 1000 global employees and eventually sold to BioClinica. Mr. Abbhi graduated with a BA in Economics from Columbia University.  

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018, and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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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  37. Funding Secured and Senior Management Team Activated by CEO to Ensure Advancement of all Operational Activities and Completion of Corporate Clinical Milestones

    Call Time: Wednesday, March 18th at 8.30 am EST

    NEW YORK, March 16, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, will hold a conference call on Wednesday, March 18th at 08:30 am Eastern Time, to update shareholders on the steps taken in order to ensure continuity of the Company's operations and support timely completion of the Company's clinical and preclinical milestones throughout the COVID-19 pandemic. The Company has already secured funding…

    Funding Secured and Senior Management Team Activated by CEO to Ensure Advancement of all Operational Activities and Completion of Corporate Clinical Milestones

    Call Time: Wednesday, March 18th at 8.30 am EST

    NEW YORK, March 16, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, will hold a conference call on Wednesday, March 18th at 08:30 am Eastern Time, to update shareholders on the steps taken in order to ensure continuity of the Company's operations and support timely completion of the Company's clinical and preclinical milestones throughout the COVID-19 pandemic. The Company has already secured funding that will allow it to complete its strategic business milestones. A senior management team has been activated by the CEO to enable timely responses to rapidly evolving external events and to ensure patient safety while maintaining clinical trial integrity and operational excellence.

    The call will be hosted by CEO, Chaim Lebovits and key members of the senior leadership team.

    Wednesday, March 18, 2020 @ 8:30am U.S. Eastern Time

    Toll Free: 1-877-423-9813

    Toll/International: 1-201-689-8573

    Webcast Audio Link:  https://bit.ly/2TPIfXe

    Reply:

    Toll Free: 1-844-512-2921
    Toll/International: 1-412-317-6671
    Replay Pin Number: 13700404
    Replay Start: Wednesday, March 18, 2020, 11:30 AM ET
    Replay Expiry: Wednesday, April 1, 2020, 11:59 PM ET

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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: 862-397-1860

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Primary Logo

    View Full Article Hide Full Article
  38. NEW YORK, March 06, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc., (NASDAQ:BCLI), a leading developer of cell technologies for neurodegenerative diseases, today announced that it has entered into a definitive agreement with Abbhi Investments, LLC, a healthcare-focused family office based in Miami, Florida, in connection with a privately negotiated sale of common stock and  a warrant to purchase common stock (collectively, the "securities"). Upon the closing of this registered direct offering, BrainStorm will receive gross proceeds of $10.0 million, resulting from the issuance and sale of 1,250,000 shares of common stock at a price per share of $8.00, a 4.9% premium to our closing share price of $7.62 on March 5, 2020, and a 35.6…

    NEW YORK, March 06, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc., (NASDAQ:BCLI), a leading developer of cell technologies for neurodegenerative diseases, today announced that it has entered into a definitive agreement with Abbhi Investments, LLC, a healthcare-focused family office based in Miami, Florida, in connection with a privately negotiated sale of common stock and  a warrant to purchase common stock (collectively, the "securities"). Upon the closing of this registered direct offering, BrainStorm will receive gross proceeds of $10.0 million, resulting from the issuance and sale of 1,250,000 shares of common stock at a price per share of $8.00, a 4.9% premium to our closing share price of $7.62 on March 5, 2020, and a 35.6% premium to the 30 day volume-weighted average price of $5.90. The purchaser will also receive a warrant to purchase up to 250,000 shares of common stock at an exercise price of $15.00 per share. The warrant will be exercisable immediately and has a term of three years.

    The securities will be issued pursuant to the Company's existing shelf registration statement on Form S-3 (File No. 333225517) (the "Registration Statement"), which was filed with the SEC and declared effective by the SEC on June 29, 2018.

    BrainStorm intends to use the proceeds from this transaction to fund its operations, which includes, but is not limited to advancing the Company's clinical programs, commercial production of the investigational therapeutic NurOwn® (whether for ALS or other indications), regulatory, pre-marketing and commercialization preparation activities of NurOwn® for ALS, working capital and general corporate purposes.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities. The securities offered and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration under the Securities Act and applicable state securities laws.

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    Corporate:
    Uri Yablonka
    Chief Business Officer
    BrainStorm Cell Therapeutics Inc.
    Phone: 646-666-3188

    Investor Relations:
    Preetam Shah, MBA, PhD
    Chief Financial Officer
    BrainStorm Cell Therapeutics Inc.
    Phone: 862-397-1860

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Primary Logo

    View Full Article Hide Full Article
  39. NEW YORK and BOSTON, Feb. 27, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced that Partners MS Center at Brigham and Women's Hospital, a leading research and clinical care center, has contracted with BrainStorm as a clinical study site for the Company's Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (MS) (NCT03799718).

    "Tanuja Chitnis, MD, Director of the CLIMB Natural History Study, which is assessing the disease course and prognosis of approximately 2000 MS patients…

    NEW YORK and BOSTON, Feb. 27, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced that Partners MS Center at Brigham and Women's Hospital, a leading research and clinical care center, has contracted with BrainStorm as a clinical study site for the Company's Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (MS) (NCT03799718).

    "Tanuja Chitnis, MD, Director of the CLIMB Natural History Study, which is assessing the disease course and prognosis of approximately 2000 MS patients, will serve as the Principal Investigator at Brigham and Women's Hospital," said Chaim Lebovits, President and CEO of BrainStorm. He added, "The Partners MS Center at Brigham and Women's Hospital provides comprehensive patient care, innovative technology and ongoing clinical research trials. We're excited to have them join the trial, and we expect that they will soon enroll participants under the supervision of Dr. Chitnis and her highly experienced clinical team."

    Ralph Kern, MD, MHSc, Chief Operating and Chief Medical Officer of BrainStorm added, "It has been less than a year since we contracted with our first progressive MS clinical site, half of the study participants have already been screened and 2 study participants have completed all study visits. We are very privileged to have Dr. Chitnis and her team advance our clinical study of NurOwn in progressive MS."

    "We are excited to participate in this research study, which will allow us the opportunity to investigate potential new therapies for our patients with progressive MS," said Chitnis, who is also a professor of Neurology at Harvard Medical School and a senior neurologist at Brigham and Women's Hospital.

    Tanuja Chitnis, MD, and the Partners MS Center at The Brigham and Women's Hospital team join the other top US MS centers: Cleveland Clinic, Stanford University, School of Medicine, Mount Sinai Medical Center and University of Southern California for the Company's Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS) (NCT03799718).

    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 repeat-dosing autologous MSC-NTF cells (NurOwn) for the treatment of amyotrophic lateral sclerosis (ALS).

    BrainStorm received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter repeat-dosing trial of autologous MSC-NTF cells (NurOwn) in progressive MS and enrollment began in March 2019. Currently half of the expected trial participants are enrolled.

    Top line results for both clinical trials are expected in the fourth quarter of 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 (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 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. For more information, visit the company's website at www.brainstorm-cell.com

    Safe-Harbor Statements

    Statements in this announcement other than historical data and information 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, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; 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

    Corporate:
    Uri Yablonka
    Chief Business Officer
    BrainStorm Cell Therapeutics Inc.
    Phone: 646-666-3188

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Primary Logo

    View Full Article Hide Full Article
  40. NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announces financial results for fiscal year ended December 31, 2019.

    "2019 was a tremendous year for BrainStorm, with significant progress and achievements across all clinical and operational fronts," stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Most importantly, we fully enrolled our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn® for the treatment of ALS. We announced the trial conducted at six major U.S. medical centers of excellence for ALS, was fully enrolled on October 11, 2019, and on October 28, 2019 the…

    NEW YORK, Feb. 18, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, today announces financial results for fiscal year ended December 31, 2019.

    "2019 was a tremendous year for BrainStorm, with significant progress and achievements across all clinical and operational fronts," stated Chaim Lebovits, President and Chief Executive Officer of BrainStorm. "Most importantly, we fully enrolled our pivotal, double blind, placebo-controlled Phase 3 trial of NurOwn® for the treatment of ALS. We announced the trial conducted at six major U.S. medical centers of excellence for ALS, was fully enrolled on October 11, 2019, and on October 28, 2019 the Data and Safety Monitoring Board (DSMB), completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 trial. The DSMB concluded the trial should continue as planned without any clinical protocol changes." He added, "In addition, one of the most prestigious peer-reviewed journals, Neurology, published ‘NurOwn Phase 2 Randomized Clinical Trial in ALS: Safety, Clinical and BioMarker Results,' bringing news of our investigational therapy to the global scientific community. And, just last week, we were happy to announce that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn regulatory pathways for approval in ALS."

    Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer of BrainStorm added, "2019 was also a very significant year for those who suffer from progressive Multiple Sclerosis (MS). In February 2019, we announced Cleveland Clinic would serve as our first contracted site for a Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) in participants with progressive MS (NCT03799718). We enrolled our first patient in March. We contracted with The Stanford University School of Medicine, The Keck School of Medicine of the University of Southern California, and the Mount Sinai Medical Center to further enroll patients." Dr. Kern added, "The importance of our research in progressive MS was acknowledged by a $495,000 grant award from the National Multiple Sclerosis Society through it's Fast Forward Program, and mid-December, the Data Safety Monitoring Board completed the first, pre-specified interim analysis, of safety outcomes for 9 participants and after careful review of all available clinical trial data, the DSMB unanimously concluded that the study should continue as planned without any protocol modification. As of December 31, 2019 we have enrolled 10 patients in the study (50% enrollment completed)."

    Fourth Quarter Corporate Highlights:

    • Received notice of US Patent Allowance for NurOwn Cellular Therapeutic Technology Platform
    • Grant of New Japanese Patent for NurOwn
    • Presentations at the 30th International Symposium on ALS/MND
    • Phase 2 Biomarker Data Presentation at NEALS 18th Annual Meeting
    • Chaim Lebovits as Keynote Speaker at Cell Series UK 2019
    • Presentation at 7th Annual International Stem Cell Meeting
    • Presentation at 35th ECTRIMS Congress
    • Presentation at Neuromuscular Drug Development Summit
    • Presentation at Dawson James Securities 5th Annual Small Cap Growth Conference

    Financial Results for the Year Ended December 31, 2019 and Recent Updates

    • Cash, cash equivalents, and short-term bank deposits were approximately $0.6 million as of December 31, 2019.
       
    • As of February 14, 2020, we raised gross proceeds of approximately $18.6 million utilizing the ATM facility.
      • Cash, cash equivalents, and short-term bank deposits as of today were approximately $11.1 million.
         
    • In addition, available funding from non-dilutive CIRM and IIA grants amounts to approximately $3.4 million.
       
    • Research and development expenses, net, for the year ended December 31, 2019 were $17.2 million, compared to $8.3 million, net for year ended December 31, 2018.
      • Excluding participation from IIA and CIRM under the grants and proceeds received under the Hospital Exemption regulatory pathway, research and development expenses increased by $8.4 million from $16.3 million for the year ended December 31, 2018 to $24.7 million for the year ended December 31, 2019.

    • General and administrative expenses for the year ended December 31, 2019 and 2018 were $5.79 million and $5.77 million respectively.
       
    • Net loss for the year ended December 31, 2019 was $23.2 million, or ($1.06) per share, as compared to a net loss of $13.9 million or ($0.70) per share for the year ended December 31, 2018.
       
    • As of February 14, 2019, the Company had 26,230,839 shares and 4,474,868 warrants issued and outstanding.

    For further details on BrainStorm's financials, including financial results for the year ended December 31, 2019, refer to the Form 10-K filed with the SEC today.

    Conference Call on Tuesday, February 18th @ 8:00 am Eastern Time

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

    Conference ID:  13698896
    Toll Free:  1-877-423-9813
    Toll/International: 1-201-689-8573
    Audio Webcast: Link to Webcast

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

    A webcast replay of the conference call will be available for 30 days on the "Investors & Media" page of BrainStorm's website:

    Toll Free: 1-844-512-2921
    Toll/International: 1-412-317-6671
    Replay Pin Number: 13698896
    Replay Start:  Tuesday February 18, 2020, 11:00 AM ET
    Replay Expiry: Tuesday March 3, 2020, 11:59 PM ET

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    Corporate:
    Uri Yablonka
    Chief Business Officer
    BrainStorm Cell Therapeutics Inc.
    Phone: 646-666-3188

    Investor Relations:
    Preetam Shah, MBA, PhD
    Chief Financial Officer
    BrainStorm Cell Therapeutics Inc.
    Phone: 862-397-8160

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    BRAINSTORM CELL THERAPEUTICS INC.

    CONSOLIDATED BALANCE SHEETS
    U.S. dollars in thousands

    (Except share data)

      December 31,
        2019
          2018  
                   
      U.S. $ in thousands
    ASSETS    
         
    Current Assets:    
    Cash and cash equivalents $ 536     $ 942  
    Short-term deposit (Note 9)   33       6,122  
    Other accounts receivable (Note 4)   2,359       2,009  
    Prepaid expenses and other current assets (Note 5)   432       1,197  
    Total current assets   3,360       10,270  
         
    Long-Term Assets:    
    Prepaid expenses and other long-term assets   32       307  
    Operating lease right of use asset (Note 6)   2,182       -  
    Property and Equipment, Net (Note 7)   960       651  
    Total Long-Term Assets   3,174       958  
                   
         
         
    Total assets $ 6,534     $ 11,228  
                   
         
         
    LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)    
         
    Current Liabilities:    
    Accounts payable $ 14,677     $ 4,548  
    Accrued expenses   1,000       1,042  
    Operating lease liability (Note 6)   1,263       -  
    Other accounts payable   714       622  
    Total current liabilities   17,654       6,212  
         
    Long-Term Liabilities:    
    Operating lease liability (Note 6)   1,103       -  
    Total long-term liabilities   1,103       -  
         
    Total liabilities $ 18,757     $ 6,212  
         
    Stockholders' Equity (deficit):    
    Stock capital: (Note 11)   11       11  
    Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2019 and December 31, 2018 respectively; Issued and outstanding: 23,174,228 and 20,757,816 shares at December 31, 2019 and December 31, 2018 respectively.    
    Additional paid-in-capital   105,042       94,620  
    Receipts on account of shares   -       4,408  
    Accumulated deficit   (117,276 )     (94,023 )
    Total stockholders' equity (deficit)   (12,223 )     5,016  
                   
         
         
    Total liabilities and stockholders' equity $ 6,534     $ 11,228  


    BRAINSTORM CELL THERAPEUTICS INC.

    CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
    U.S. dollars in thousands

    (Except share data)

      Year ended
      December 31,
        2019       2018
     
                   
      U.S. $ in thousands
         
    Operating expenses:    
         
    Research and development, net (Note 12) $ 17,204     $ 8,293  
    General and administrative   5,797       5,770  
                   
         
    Operating loss   (23,001 )     (14,063 )
         
    Financial expenses (income), net   252       (115 )
                   
         
    Net loss $ (23,253 )   $ (13,948 )
                   
         
         
    Basic and diluted net loss per share $ (1.06 )   $ (0.70 )
                   
         
         
    Weighted average number of shares outstanding used in computing basic and diluted net loss per share   21,906,257       19,997,710  


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  41. NEW YORK, Feb. 17, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of autologous cellular therapies for highly debilitating neurodegenerative diseases, announced that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will provide a clinical update on the Company's ALS and MS trials and present insights on the future growth strategy of BrainStorm at the Noble Capital Markets' Sixteenth Annual Investor Conference, taking place February 16-18, 2020 at the Hard Rock Hotel & Casino, Hollywood, Florida.

    BrainStorm has a fully enrolled 200-patient Phase 3 clinical trial evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic…

    NEW YORK, Feb. 17, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of autologous cellular therapies for highly debilitating neurodegenerative diseases, announced that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will provide a clinical update on the Company's ALS and MS trials and present insights on the future growth strategy of BrainStorm at the Noble Capital Markets' Sixteenth Annual Investor Conference, taking place February 16-18, 2020 at the Hard Rock Hotel & Casino, Hollywood, Florida.

    BrainStorm has a fully enrolled 200-patient Phase 3 clinical trial evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 ALS trial.

    Additionally, BrainStorm is enrolling patients in an investigational Phase 2 clinical trial of NurOwn for progressive MS, a disease with enormous unmet medical need.

    Presentation Details:

    Title:   BrainStorm Corporate Update for Current and Future Investors
    Presenter:    Ralph Kern M.D., CMO, BrainStorm Cell Therapeutics 
    Date:   Monday, February 17, 2020
    Time:    12:00 PM Eastern Time

    Click Here For the Webcast of Brainstorm's Presentation

    ** The video webcast will be available starting February 18, 2020 for 90 days **

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    About Noble Capital Markets, Inc.
    Noble Capital Markets ("Noble") is a research driven boutique investment bank that has supported small & microcap companies since 1984. As a FINRA and SEC licensed broker dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management and order execution services. In 2005, Noble established NobleCon, an investor conference that has grown substantially over the last decade. In 2018 Noble launched www.channelchek.com - a new investment community dedicated exclusively to small and micro-cap companies and their industries. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 emerging growth companies are listed on the site, with growing content including webcasts, podcasts, and balanced news.

    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
    Corporate
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Or

    Katie Gallagher | Account Director, PR and Marketing
    LaVoieHealthScience Strategic Communications
    O: 617-374-8800 x109
    M: 617-792-3937

     

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  42. NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn® regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

    In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data…

    NEW YORK, Feb. 11, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc., (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company recently held a high level meeting with the U.S. Food and Drug Administration (FDA) to discuss potential NurOwn® regulatory pathways for approval in ALS. Repeated intrathecal administration of NurOwn (autologous MSC-NTF cells) is currently being evaluated in a fully enrolled Phase 3 pivotal trial in ALS (NCT03280056).

    In the planned meeting with senior Center for Biologics Evaluation and Research (CBER) leadership and several leading U.S. ALS experts, the FDA confirmed that the fully enrolled Phase 3 ALS trial is collecting relevant data critical to the assessment of NurOwn efficacy. The FDA indicated that they will look at the "totality of the evidence" in the expected Phase 3 clinical trial data. Furthermore, based on their detailed data assessment, they are committed to work collaboratively with BrainStorm to identify a regulatory pathway forward, including opportunities to expedite statistical review of data from the Phase 3 trial. 

    Both the FDA and BrainStorm acknowledged the urgent unmet need and the shared goal of moving much needed therapies for ALS forward as quickly as possible.

    "This is a key turning point in our work toward providing ALS patients with a potential new therapy," said Chaim Lebovits, President and CEO of BrainStorm. "We commend the FDA for its commitment to the ALS community and to facilitating the development, and we ultimately hope, the approval of NurOwn. The entire BrainStorm team is grateful for the ongoing and conscientious collaboration in the quest to beat ALS."

    Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, stated, "The entire team at BrainStorm has collectively worked to ensure that we conduct the finest, science-based clinical trials. We had the opportunity to communicate with Senior Leadership at the FDA and discuss how we can work together to navigate the approval process forward along a novel pathway. We appreciate their willingness and receptiveness to consider innovative approaches as we all seek to better serve the urgent unmet medical needs of the ALS community."

    Brian Wallach, Co-Founder of I AM ALS stated: "There is nothing more important to those living with ALS than having access to therapies that effectively combat this fatal disease. We have been working with BrainStorm for months now because we believe that NurOwn is a potentially transformative therapy in this fight. We were privileged to represent the patient voice at this meeting and are truly grateful to the company and the FDA for this critical agreement. This is a truly important moment of hope and we look forward to seeing both the Phase III data and the hopeful approval of NurOwn as soon as is possible."

    About NurOwn®
    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    Corporate
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Or

    Katie Gallagher | Account Director, PR and Marketing
    LaVoieHealthScience Strategic Communications
    O: 617-374-8800 x109
    M: 617-792-3937

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  43. NEW YORK, Feb. 10, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and full year ended December 31, 2019, and provide a corporate update, at 8:00 a.m., Eastern Time, on Tuesday, February 18, 2020. 

    BrainStorm's President & CEO, Chaim Lebovits, will present the full year 2019 corporate update, after which, participant questions will be answered.  Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD…

    NEW YORK, Feb. 10, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that the Company will hold a conference call to update shareholders on financial results for the fourth quarter and full year ended December 31, 2019, and provide a corporate update, at 8:00 a.m., Eastern Time, on Tuesday, February 18, 2020. 

    BrainStorm's President & CEO, Chaim Lebovits, will present the full year 2019 corporate update, after which, participant questions will be answered.  Joining Mr. Lebovits to answer investment community questions will be Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, and Preetam Shah, PhD, Chief Financial Officer.

    Participants are encouraged to submit their questions prior to the call by sending them to:  and questions should be submitted by 5:00 p.m., Eastern Time, Monday, February 17 2020. 

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

    Conference ID:    13698896
    Toll Free:    1-877-423-9813
    Toll/International:    1-201-689-8573
    Audio Webcast:    Link to Webcast

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

    A webcast replay of the conference call will be available for 30 days on the "Investors & Media" page of BrainStorm's website:

    Toll Free:    1-844-512-2921
    Toll/International:    1-412-317-6671
    Replay Pin Number:    13698896
    Replay Start:    Tuesday February 18, 2020, 11:00 AM ET
    Replay Expiry:    Tuesday March 3, 2020, 11:59 PM ET

    About NurOwn®

    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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: 862-397-8160 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839
     

     

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  44. NEW YORK, Feb. 04, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that Chaim Lebovits, CEO and President, will provide an update of the Company's ALS and MS trials and company growth strategy at The BIO CEO & Investor Conference, being held February 10-11, 2020 at the New York Marriott Marquis.

    Brainstorm has a fully enrolled 200-patient Phase 3 clinical trial (NCT03280056) evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the…

    NEW YORK, Feb. 04, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that Chaim Lebovits, CEO and President, will provide an update of the Company's ALS and MS trials and company growth strategy at The BIO CEO & Investor Conference, being held February 10-11, 2020 at the New York Marriott Marquis.

    Brainstorm has a fully enrolled 200-patient Phase 3 clinical trial (NCT03280056) evaluating repeat intrathecal administration of NurOwn® cellular therapeutic (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). In late October 2019, the Data and Safety Monitoring Board (DSMB) completed the second planned interim safety analysis for the first 106 patients who received repeat dosing of NurOwn in the Phase 3 ALS trial.

    Additionally, Brainstorm is enrolling participants in the Phase 2 study of repeat intrathecal administration of NurOwn for progressive MS, a disease with significant unmet medical need.

    Presentation and Webcast Details:
    Presenter: Chaim Lebovits, CEO, BrainStorm Cell Therapeutics, NYC, NY.
    Date: Tuesday, February 11, 2020
    Time: 10:30 am Eastern Time
    Webcast Link: https://bit.ly/31r0nJd
    Replays of the webcast will be available 1 hour after the presentation through May 12, 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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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) for ALS. Brainstorm has fully enrolled the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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
    Corporate
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839
     

    Primary Logo

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  45. NEW YORK, Jan. 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the European Patent Office (EPO) has communicated its intention to grant a European patent titled 'Methods of Generating Mesenchymal Stem Cells which secrete Neurotrophic Factors'. Allowed claims cover the method for manufacturing MSC-NTF cells (NurOwn®).

    "We continue to protect our technology through strategic intellectual property achievements and the intention to grant this patent by the European Patent Office is a welcome addition to our IP portfolio. This patent covers the industrial manufacturing process for NurOwn® developed by Brainstorm's…

    NEW YORK, Jan. 29, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the European Patent Office (EPO) has communicated its intention to grant a European patent titled 'Methods of Generating Mesenchymal Stem Cells which secrete Neurotrophic Factors'. Allowed claims cover the method for manufacturing MSC-NTF cells (NurOwn®).

    "We continue to protect our technology through strategic intellectual property achievements and the intention to grant this patent by the European Patent Office is a welcome addition to our IP portfolio. This patent covers the industrial manufacturing process for NurOwn® developed by Brainstorm's scientists," commented Brainstorm's CEO Chaim Lebovits. "Adding this EU patent to our patents granted in the United States, Canada, Israel and Japan, should increase our ability to enter into new commercial partnerships for NurOwn in the EU and worldwide."

    About NurOwn®

    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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® Cellular Therapeutic Technology Platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement as well as through its own patents, patent applications and proprietary know-how. 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 the Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a BLA filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. Brainstorm received U.S. FDA clearance to initiate a Phase 2 open-label multi-center trial of repeat intrathecal dosing of MSC-NTF cells in Progressive Multiple Sclerosis (NCT03799718) in December 2018 and has been enrolling clinical trial participants since March 2019. For more information, visit the company's website.

    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

    Corporate
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Primary Logo

    View Full Article Hide Full Article
  46. NEW YORK and LOS ANGELES, Jan. 21, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will present at the 10th Annual California ALS Research Summit, January 24-25 at Cedars-Sinai Medical Center, Los Angeles, California. 

    Dr. Kern will provide an update on BrainStorm's Phase 3 ALS Clinical Trial on Friday, January 24, 10:30 -11:10 AM PT, during the session: "CIRM funded Stem Cell Clinical Trials in California – Updates."

    Dr. Kern stated, "This prestigious Summit works to increase, expedite and promote the amount and level of amyotrophic lateral…

    NEW YORK and LOS ANGELES, Jan. 21, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, MD, MHSc, Chief Operating Officer and Chief Medical Officer, will present at the 10th Annual California ALS Research Summit, January 24-25 at Cedars-Sinai Medical Center, Los Angeles, California. 

    Dr. Kern will provide an update on BrainStorm's Phase 3 ALS Clinical Trial on Friday, January 24, 10:30 -11:10 AM PT, during the session: "CIRM funded Stem Cell Clinical Trials in California – Updates."

    Dr. Kern stated, "This prestigious Summit works to increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS) research done in California that has been reinforced and amplified by the international ALS scientific and medical community. I am pleased to have the opportunity to share all that BrainStorm has accomplished in our fully enrolled Phase 3 clinical trial of NurOwn® (NCT03280056)."

    Chaim Lebovits, President and CEO of BrainStorm, stated, "California continues to be a global leader in stem cell research and scientific funding. Due to California's commitment to stem cell scientific investigation, BrainStorm is at an inflection point as we bring our investigational therapy, NurOwn, toward the submission of a biological license application. In July 2017, BrainStorm was awarded a grant of $15.9 million from the California Institute for Regenerative Medicine (CIRM) and three of California's most prestigious medical centers: University of California, Irvine, Cedars-Sinai Medical Center, and California Pacific Medical Center have contributed immensely to advancement of NurOwn. Everyone at BrainStorm is proud Dr. Kern will have the opportunity to present to the ALS community of California all that has been accomplished due to their ongoing support and encouragement."               

    About The California ALS Research Summit:

    The California ALS Research Summit is the tenth annual gathering of researchers, investigators, clinicians, biotech companies, government representatives, partner organizations, and advocates in ALS and related fields in the State of California.

    The purpose of the Summit is to help increase, expedite and promote the amount and level of amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's Disease) and related research done in California; and to foster networking, collaboration and cooperation among investigators, their peers and their colleagues to identify, develop and deliver new and effective treatments, ideas and, ultimately, cures for ALS.

    The result of our efforts is an ongoing roadmap for ALS research in California, which will provide the basis for partnering within the state and other supporters to further studies to find new treatments and ultimately a cure for the disease. 

    About NurOwn®

    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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 sites in the U.S., 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. For more information, visit BrainStorm'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

    Corporate
    Uri Yablonka 
    Chief Business Officer 
    BrainStorm Cell Therapeutics Inc. 
    Phone: 646-666-3188 

    Media:
    Sean Leous
    Westwicke/ICR PR
    Phone: +1.646.677.1839

    Or:
    Katie Gallagher
    LaVoieHealthSciences
    Phone: + 1 617-374-8800 x109
     

    Primary Logo

    View Full Article Hide Full Article
  47. NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Chaim Lebovits, President and Chief Executive Officer, will provide a corporate overview at the 2020 Biotech Showcase, being held on January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

    Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines' Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorm's Chief Operating Officer and Chief Medical Officer, will participate on a Rare & Orphan Diseases Panel.  

    2020 Biotech

    NEW YORK, Jan. 07, 2020 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Chaim Lebovits, President and Chief Executive Officer, will provide a corporate overview at the 2020 Biotech Showcase, being held on January 13-15, 2020 at the Hilton San Francisco Union Square in San Francisco, California.

    Mr. Lebovits will also present at the 3rd Annual Neuroscience Innovation Forum, taking place on January 12, 2020, at the Marines' Memorial Club in San Francisco. Additionally, Ralph Kern M.D., MHSc, BrainStorm's Chief Operating Officer and Chief Medical Officer, will participate on a Rare & Orphan Diseases Panel.  

    2020 Biotech Showcase Details
    Date: Monday, January 13, 2020
    Time: 11:00 am Pacific Time
    Location: Hilton San Francisco Union Square, Hilton/Yosemite A, Ballroom Level
    Presenter: Chaim Lebovits, CEO
    Webcast: https://bit.ly/37EfFfC


    3nd Annual Neuroscience Innovation Forum 
    Details:
    Company Presentation:  
    Date: Sunday, January 12, 2020
    Time: 2:10 pm Pacific Time
    Location: Marines' Memorial Club, SF
    Presenter: Chaim Lebovits, CEO
    Webcast: https://bit.ly/2T4ZeFj


    Rare & Orphan Disease Panel: Details
    Date: Sunday, January 12, 2020
    Time: 10:45 am Pacific Time
    Location: Marines' Memorial Club, SF
    Presenter: Dr. Ralph Kern, COO & CMO

    Meetings

    BrainStorm's senior management will also be hosting institutional investor and partnering meetings at the 2020 Biotech Showcase conference (https://goo.gl/SGFm62). Please use the Investor contact information provided below to schedule a meeting. 

    About NurOwn®

    NurOwn® (autologous MSC-NTF cells) represent a promising investigational 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. NurOwn® is currently being evaluated in a Phase 3 ALS randomized placebo-controlled trial and in a Phase 2 open-label multicenter trial in Progressive MS.

    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 sites in the U.S., 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. For more information, visit BrainStorm'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, expectat