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.

Brainstorm Cell Therapeutics Inc. (BCLI) CEO Chaim Lebovits on Q3 2021 Results - Earnings Call Transcript

NEW YORK, Nov. 15, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced financial results for the quarter ended September 30, 2021, and provided a corporate update. "We made strong progress towards our goal of advancing NurOwn in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics.

BrainStorm Cell Therapeutics Announces Third Quarter 2021 Financial Results and Provides a Corporate Update

NEW YORK, Nov. 8, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced executive appointments as the company prepares for future growth. Sidney A. Spector, MD, PhD, was named Senior Vice President Global Strategy and Medical Affairs and Kim Thacker, MD, was named Senior Vice President, Medical Affairs and Clinical Innovation.

BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs

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

Brainstorm Cell Therapeutics Announces Appointment of Menghis Bairu, MD, to Board of Directors

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

BrainStorm to Announce Third Quarter Financial Results and Provide a Corporate Update

NEW YORK, Oct. 18, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced the presentation today of a poster titled, "Therapeutic Benefits of MSC-NTF (NurOwn®) Exosomes in Acute Lung Injury Models" at the NYSCF 2021 VIRTUAL Meeting, being held on October 19-20, 2021.  The poster will be presented tomorrow, October 19, at 3:45 – 5:00pm Eastern Time.

BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at NYSCF 2021 VIRTUAL Meeting

NEW YORK, Oct. 14, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, will present findings from a multicenter, open label clinical trial of NurOwn® in progressive multiple sclerosis.  The study, "Phase 2 Safety and Efficacy Study of Intrathecal MSC-NTF cells in Progressive Multiple Sclerosis," will be delivered in an oral presentation today at the fully digital 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Phase 2 Clinical Trial Data of NurOwn® in Progressive MS Will Be Presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)

NEW YORK, Oct. 6, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that a scientific abstract titled "CSF biomarker correlations with primary outcome in NurOwn Phase 3 clinical trial" will be presented as a scientific poster at the fully digital 2021 Northeast Amyotrophic Lateral Sclerosis Consortium® (NEALS) conference.  The presentation will be delivered by James Berry, M.D.

BrainStorm to Present ALS Phase 3 Biomarker Analyses at Annual NEALS Meeting October 6th, 2021

NEW YORK, Oct. 4, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that Stacy Lindborg, Ph.D., Executive Vice President and Head of Global Clinical Research, will deliver a presentation at the 2021 Cell & Gene Meeting on the Mesa, being held as a hybrid conference October 12-14, and October 19-20, 2021.

BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa

NEW YORK, Oct. 1, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that a scientific abstract titled "Phase 2 Safety and Efficacy Study of Intrathecal MSC-NTF cells in Progressive Multiple Sclerosis" will be presented in an oral presentation at the fully digital 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).  The presentation will be delivered by Jeffrey Cohen, M.D.

BrainStorm to Present Phase 2 Progressive MS Study Results in Oral Presentation at 37th Congress of ECTRIMS

BrainStorm Cell Therapeutics Inc. (BCLI) CEO Chaim Lebovits on Q2 2021 Results - Earnings Call Transcript

NEW YORK, Aug. 5, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results for the first quarter ended June 30, 2021 and provided a corporate update. "We continue to take important steps to advance NurOwn in ALS and progressive MS and position ourselves for sustained success," said Chaim Lebovits, Chief Executive Officer of BrainStorm.

BrainStorm Announces Second Quarter 2021 Financial Results and Provides a Corporate Update

NEW YORK, July 27, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that is has received Good Manufacturing Practice (GMP) approval from the Israel Ministry of Health for three state-of-the-art cleanrooms leased by the Company at the Tel Aviv Sourasky Medical Center ("Sourasky Hospital") in Tel Aviv, Israel. The GMP approval confirms that these cleanrooms are compliant with Israeli GMPs, which are aligned with European Union (EU) GMPs, and more than doubles the Company's capacity to manufacture and ship NurOwn® into the EU and local Israeli markets.

BrainStorm Increases Commercial Manufacturing Capacity; Granted GMP Certification for a Second Production Site in Israel

NEW YORK, July 26, 2021 /PRNewswire/ --BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2021, and provide a corporate update, at 8:00 a.m. Eastern Time on August 05, 2021.

BrainStorm to Announce Second Quarter Financial Results and Provide a Corporate Update

NEW YORK, June 15, 2021 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the grant and/or allowance of a series of patents and patent applications. These patents and patent applications, which were granted/allowed in 2020 and 2021, are expected to provide broad protection for Brainstorm's proprietary NurOwn® (MSC-NTF cells) technology in territories including the U.S., E.U.

Brainstorm Announces Expansion of NurOwn® IP Portfolio with Grant and Allowance of Multiple Patents and Applications in Major Markets

Brainstorm Cell Therapeutics, Inc. is a biotechnology company developing best-in-class autologous cell therapies for treating neurodegenerative diseases including ALS, PMS, Alzheimer's, and others. Brainstorm's modified mesenchymal stem cells are being tested in one ongoing Phase 2 trial for PMS (promising top-line data) and one soon-to-be-initiated Phase 2 trial for Alzheimer's.

Brainstorm Cell Therapeutics: MSC-NTF Cell Therapy Shows Mid-Stage Promise In PMS

NEW YORK, May 25, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced the presentation today of a poster titled, "Molecular Mechanisms Underlying MSC-NTF (NurOwn®) Exosome Benefits in a Mouse LPS-induced ARDS Model" at the ISCT 2021 New Orleans VIRTUAL Meeting, being held from May 25-28, 2021.  The poster will be presented during Virtual Poster Hall Session 2: May 25, 20:00-21:30 EDT.

BrainStorm Announces Scientific Presentation of NurOwn® Exosome Preclinical ARDS Data at ISCT 2021 New Orleans VIRTUAL Meeting

BrainStorm Cell Therapeutics Inc. (BCLI) CEO Chaim Lebovits on Q1 2021 Results - Earnings Call Transcript

NEW YORK, April 26, 2021 /PRNewswire/ -- 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, 2021 and provided a corporate update. "In the first quarter we were excited to announce positive top line data from our Phase 2 trial evaluating NurOwn ® as a treatment for progressive multiple sclerosis (MS).

BrainStorm Announces First Quarter 2021 Financial Results and Provides a Corporate Update

NEW YORK, April 19, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the first quarter ended March 31, 2021, and provide a corporate update, at 8:00 a.m. Eastern Time on April 26, 2021.

BrainStorm to Announce First Quarter Financial Results and Provide a Corporate Update

The stock price of Brainstorm Cell Therapeutics Inc (NASDAQ: BCLI) increased by over 25% pre-market. This is why it happened.

BCLI Stock Price Increases Over 25% Pre-Market: Why It Happened

BrainStorm Cell Therapeutics Inc (NASDAQ: BCLI) has reported topline Phase 2 data evaluating three repeated administrations of NurOwn (MSC-NTF cells), each given two months apart, as a treatment for progressive multiple sclerosis (MS). The study achieved the primary endpoint of safety, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers.

BrainStorm Cell Stock Surges As NurOwn Aces Mid-Stage Multiple Sclerosis Study

NEW YORK, March 24, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, announced today topline data from the Company's Phase 2 trial evaluating three repeated administrations of NurOwn® (MSC-NTF cells), each given 2 months apart, as a treatment for progressive multiple sclerosis (MS). The study achieved the primary endpoint of safety and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers.

BrainStorm Announces Positive Topline Data in Phase 2 Study Evaluating NurOwn® as a Treatment for Progressive MS

NEW YORK--(BUSINESS WIRE)--Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Brainstorm Cell Therapeutics Inc. ("Brainstorm" or "the Company") (NASDAQ: BCLI). Investors who purchased Brainstorm securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: www.bgandg.com/bcli. The investigation concerns whether Brainstorm and certain of its officers and/or directors have violated federal secu

Bronstein, Gewirtz & Grossman, LLC Notifies Investors of Brainstorm Cell Therapeutics Inc. (BCLI) Investigation

The FDA's initial review concluded that current data from BrainStorm Cell Therapeutics Inc's (NASDAQ: BCLI) NurOwn Phase 3 trial in amyotrophic lateral sclerosis (ALS) does not sufficiently provide the threshold of substantial evidence to support the marketing application. Also, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a marketing application submission.

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