Brainstorm Cell Therapeutics

Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. It focuses on utilizing the patients own bone marrow stem cells to generate neuron-like cells that may provide an effective treatment initially for amyotrophic lateral sclerosis, Parkinson's disease, multiple sclerosis and spinal cord injury. The company was founded on September 22, 2000 and is headquartered in New York, NJ.

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Brainstorm Cell Therapeutics reports financials, faces credibility challenges on unblinding

Brainstorm Cell Therapeutics showcased financial investment in R&D and highlighted positive testimonials for NurOwn's ALS treatment.
Maintaining blinding for trial integrity and emphasizing industry best practices demonstrate commitment to ethical standards.
Challenges include balancing individual requests for unblinding with overall trial integrity and addressing concerns around credibility.
Opportunities lie in enhancing communication, addressing unblinding concerns, and leveraging community support for market access.

Brainstorm Cell Therapeutics advances NurOwn towards regulatory approval amidst financial constraints

Brainstorm Cell Therapeutics showcased progress in regulatory milestones, clinical data analysis, and organizational enhancements during the Q1 2023 Earnings Call
While demonstrating strengths in clinical efficacy and strategic leadership appointments, the company faces challenges in financial constraints and the need for further clarity in certain areas
Opportunities lie in advancing towards regulatory approval, leveraging strategic hires for growth, and exploring diversification through international expansion and innovation

BrainStorm Cell Therapeutics readies for FDA review of NurOwn

BrainStorm Cell Therapeutics is actively preparing for the FDA review of NurOwn, with a focus on commercial readiness and engaging with physicians. Despite financial challenges, the company raised funds and is optimistic about future growth. BrainStorm's expansion into new indications and potential collaborations highlight strategic opportunities for the company.

Brainstorm Cell Therapeutics adjusts strategy post BLA withdrawal

Brainstorm Cell Therapeutics navigated challenges with a strategic realignment and capital constraints.
The company is focusing on partnerships, exosome technology, and advancing their ALS program.
Opportunities lie in raising capital, exploring collaborations, and leveraging exosome technology.
Seeking regulatory de-risking and diversification through exosome tech are key strategies.

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Brainstorm Cell Therapeutics, Inc. is a biotechnology company, which develops and commercializes autologous cellular therapies for the treatment of neurodegenerative diseases, including Amyotrophic Lateral Sclerosis, Progressive Multiple Sclerosis, Alzheimer's disease, and other neurodegenerative diseases. Its pipeline, NurOwn proprietary cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells to secrete high levels of neurotrophic factors, modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival, and improve neurological function. The company was founded by Irit Arbel on September 22, 2000 and is headquartered in New York, NY.

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 Announces Groundbreaking Pre-Clinical Study of NurOwn® derived Exosome-Based Treatment for COVID-19 ARDS

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....

BrainStorm Hosting KOL Webinar to Discuss NurOwn® Phase 2 Alzheimer's Disease Program

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...

BrainStorm Announces Completion of All Dosing in NurOwn® Phase 3 Clinical Trial in ALS

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....

BrainStorm Expands Clinical Pipeline to Evaluate NurOwn® for the Treatment of Alzheimer's Disease

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 .

BrainStorm Granted SME Status by the European Medicines Agency

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...

BrainStorm to Present at the Raymond James Human Health Innovations Conference

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...

The ALS Association, I AM ALS Award BrainStorm Cell Therapeutics $500,000 for ALS Biomarker Study

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...

BrainStorm to Participate in BIO Digital 2020

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...

BrainStorm Announces that Pivotal Phase 3 Trial Remains on Track for Topline Data in Q4-2020

NEW YORK, May 27, 2020 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today that Stacy R. Lindborg, Ph.D. has been appointed Executive Vice President Head of Global Clinical...

BrainStorm Appoints Pharmaceutical Veteran Stacy R. Lindborg, Ph.D.

BrainStorm Cell Therapeutics Inc. (BCLI) CEO Chaim Lebovits on Q1 2020 Results - Earnings Call Transcript

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  .

BrainStorm Leases a New Cleanroom Facility at The Tel Aviv Sourasky Medical Center to Manufacture NurOwn® for The European Union

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 .

BrainStorm Presents New Data Highlighting NurOwn® Immunomodulation in Neurology

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 Awarded $1.5 Million Non-Dilutive Grant for 2020 by the Israel Innovation Authority

Prof. Frenkel, Chairman of the Group of Thirty (G-30) Board of Trustees, Former Chairman of JPMorgan Chase International and Former Governor of the Bank of Israel Joins the Board to Support the Company’s Global Expansion Prof. Frenkel, Chairman of the Group of Thirty (G-30) Board of Trustees, Former Chairman of JPMorgan Chase International and Former Governor of the Bank of Israel Joins the Board to Support the Company’s Global Expansion

BrainStorm Appoints Renowned Distinguished Economist, Prof. Jacob Frenkel, Chairman of the Board of Directors

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.

BrainStorm Cell Therapeutics Raises $10.0 Million in Common Stock Sale at $8.00 Per Share

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 ).

Fifth and Final Site Announced for BrainStorm’s Progressive Multiple Sclerosis Phase 2 Clinical Trial

BrainStorm Cell Therapeutics Inc.'s (BCLI) CEO Chaim Lebovits on Q4 2019 Results - Earnings Call Transcript

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).

BrainStorm Cell Therapeutics and FDA Agree to Potential NurOwn® Regulatory Pathway for Approval in ALS

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®).

BrainStorm Receives Notice of Intention to Grant Additional EU patent for NurOwn®

NEW YORK, Dec.  19, 2019  (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics, Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that the clinical trial independent Data Safety Monitoring Board (DSMB) has completed the first, pre-specified interim analysis, of safety outcomes for 9 participants enrolled in the Phase 2 open-label, multicenter study of repeated intrathecal administration of NurOwn® (autologous MSC-NTF cells) in participants with progressive Multiple Sclerosis (MS) ( NCT03799718 ). After careful review of all available clinical trial data, the DSMB unanimously concluded “the study should continue as planned without any protocol modification”.

NurOwn® Data Safety Monitoring Board Recommends MS Phase 2 Clinical Trial Continue

NEW YORK, Dec.  18, 2019  (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapeutics for neurodegenerative diseases, today issued a Letter to Shareholders.

BrainStorm Issues 2019 Letter to Shareholders

NEW YORK, Dec.  11, 2019  (GLOBE NEWSWIRE) --  BrainStorm Cell Therapeutics Inc.  ( NASDAQ: BCLI ), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced, that it was selected as the Buzz of BIO, in the Public Therapeutics Biotech category, and due to extensive voter participation BrainStorm also received an invitation to make a complimentary company presentation at the  BIO CEO & Investor Conference  , to be held in New York City on February 10-11, 2020.

BrainStorm Selected as Buzz of BIO 2020 Winner

NEW YORK, Nov.  25, 2019  (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. ( NASDAQ: BCLI ), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced that The  Mount Sinai  Medical Center, internationally acclaimed for its excellence in research, patient care, and education in multiple sclerosis and across a range of medical specialties, 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 ).

BrainStorm Announces the Mount Sinai Medical Center as a Progressive MS Phase 2 Clinical Trial Site

NEW YORK, Nov.  20, 2019  (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. ( NASDAQ: BCLI ), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, today announced publication of “NurOwn Phase 2 Randomized Clinical Trial in ALS: Safety, Clinical and BioMarker Results,” in the international, peer-reviewed journal   Neurology   :  Volume 93, Number 24  (Published ahead of print.)

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