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.

NurOwn® drove biomarker responses, affecting pathways related to neurodegeneration, neuroinflammation, and neuroprotection, that were consistent in participants with both advanced ALS and less advanced disease, confirming the importance of accounting for ALSFRS-R floor effects when evaluating clinical endpoints NEW YORK , Oct. 7, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the presentation of new biomarker analyses supporting the therapeutic benefit of NurOwn® in amyotrophic lateral sclerosis (ALS) at the ongoing 5th Annual ALS ONE Research Symposium. The presentation was delivered by Dr. Stacy Lindborg, Chief Development Officer at Brainstorm, and entitled, "The Relationship between CSF Biomarkers and Efficacy of Treatment with NurOwn (MSC-NTF cells).

BrainStorm Presents New Biomarker Analyses from NurOwn's Phase 3 ALS Trial at the ALS ONE Research Symposium

Data demonstrate NurOwn's safety and provide preliminary evidence of efficacy in patients with progressive multiple sclerosis Biomarker analyses show consistent treatment effects in neuroinflammation and neuroprotection pathways NEW YORK , Sept. 15, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the peer reviewed publication of data from the Phase 2 trial of NurOwn in progressive multiple sclerosis (MS) in Multiple Sclerosis Journal.

BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn® Phase 2 Progressive MS Trial in Multiple Sclerosis Journal

Brainstorm Cell Therapeutics is a company developing NurOwn as an autologous stem cell-based treatment for ALS and MS. NurOwn's mechanism of action relies on bringing down neuroinflammation and altering glial activity, a recipe that seems to be a winner in neurodegenerative diseases.

Brainstorm Cell Therapeutics: Upcoming BLA In ALS

The stock price of Brainstorm Cell Therapeutics Inc (BCLI) fell by 1.43% in the previous trading session. This is why.

Brainstorm Cell Therapeutics Inc (BCLI) Stock: Why It Fell 1.43%

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q2 2022 Earnings Conference Call August 15, 2022 8:00 AM ET Company Participants Tom Galassi - Investor Relations, LifeSci Advisors Chaim Lebovits - Chief Executive Officer Stacy Lindborg - Executive Vice President and Chief Development Officer Ralph Kern - President and Chief Medical Officer Alla Patlis - Interim Chief Financial Officer David Setboun - Executive Vice President and Chief Operating Officer Conference Call Participants David Bautz - Zacks Small-Cap Daniel Walker - Ness Industries Operator Greetings ladies and gentlemen and welcome to the Brainstorm Cell Therapeutics Second Quarter 2022 Conference Call. At this time, participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc.'s (BCLI) CEO Chaim Lebovits on Q2 2022 Results - Earnings Call Transcript

BrainStorm to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NurOwn ®  for the treatment of ALS New clinical analyses reinforce the conclusions from NurOwn's® Phase 3 clinical trial Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , Aug. 15, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2022, and provided a corporate update.

BrainStorm Cell Therapeutics Announces Second Quarter 2022 Financial Results and Provides a Corporate Update

NEW YORK , Aug. 1, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today that it will hold a conference call to update shareholders on financial results for the second quarter, ended on June 30, 2022, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, August 15, 2022.

BrainStorm to Announce Second Quarter Results and Provide a Corporate Update

Analyses accounting for ALSFRS-R floor effect in ALS yields new results to be presented at the ENCALS meeting in Edinburgh, Scotland Clinical, biomarker and preclinical data from NurOwn® Phase 2 clinical trial in MS to be presented at CMSC meeting in National Harbor, MD, USA NEW YORK , May 31, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announces presentations at forthcoming ALS and MS scientific conferences in June 2022.  Insights into the ALS Phase 3 primary endpoint leveraging ENCALS model patient prognosis trajectories will be presented as a scientific poster at the European Network to Cure ALS (ENCALS) meeting in Edinburgh, Scotland June 1-3, 2022.

BrainStorm Announces Presentations at June 2022 Scientific Conferences

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q1 2022 Earnings Conference Call May 16, 2022 8:00 AM ET Company Participants Tom Galassi - Investor Relations, LifeSci Advisors Chaim Lebovits - Chief Executive Officer Alla Patlis - Interim Chief Financial Officer Stacy Lindborg - Executive Vice President and Chief Development Officer Ralph Kern - President and Chief Medical Officer David Setboun - Executive Vice President and Chief Operating Officer Conference Call Participants David Bautz - Zacks Small-Cap Research Michelle Lorenz - Voices for ALS Operator Greetings and welcome to the Brainstorm Cell Therapeutics First Quarter 2022 Conference Call. At this time, participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc.'s (BCLI) CEO Chaim Lebovits on Q1 2022 Results - Earnings Call Transcript

BrainStorm continues to gain insights and perspectives from leading ALS experts as it seeks the optimal path forward to provide broad patient access to NurOwn® Strengthened executive team in preparation for anticipated growth and corporate development, with the appointment of Netta Blondheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Avd, as Chief Legal Counsel Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , May 16, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the first quarter ended March 31, 2022 and provided a corporate update.

BrainStorm Cell Therapeutics Announces First Quarter 2022 Financial Results and Provides a Corporate Update

Netta Blondheim-Shraga, PhD Appointed as VP R&DAntal Pearl-Lendner, Adv. Appointed as Chief Legal Counsel  NEW YORK , May 12, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced two senior management appointments.

BrainStorm Strengthens Executive Team with Key Appointments in R&D and Legal

NurOwn-derived exosomes showed more potent anti-inflammatory effects in vitro compared to naïve mesenchymal stem cell-derived exosomes NEW YORK , May 4, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced the presentation today of a poster titled, "MSC-NTF derived small extracellular vesicles display superior macrophage immunomodulation compared with vesicles derived from naïve MSCs," at the International Society of  Cell & Gene Therapy ISCT 2022 Meeting, being held from May 4-7, 2022 in San Francisco, CA. The poster will be presented by Dr. Kim Thacker, Senior Vice President, Medical Affairs and Clinical Innovation, BrainStorm Cell Therapeutics.

BrainStorm Announces Presentation of NurOwn® Exosome Preclinical Data at ISCT 2022 San Francisco Meeting

Data on MSC-NTF exosome technology at ISCT 2022 and ISEV 2022 conferences NurOwn® CFS biomarker analysis to be presented at ALS Drug Development Summit NEW YORK , May 3, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announces presentations at upcoming scientific conferences in May 2022.  New data on the company's proprietary MSC-NTF exosome technology will be presented at ISCT 2022 (May 4 to 7 in San Francisco, CA) and at the ISEV 2022 Annual Meeting (May 25 to 29 in Lyon, France).

BrainStorm Announces Upcoming Scientific Conference Presentations

NEW YORK , May 2, 2022 /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, 2022, and provide a corporate update, at 8:00 a.m. Eastern Time on May 16, 2022.

BrainStorm to Announce First Quarter 2022 Financial Results and Provide a Corporate Update

BrainStorm Cell Therapeutics Inc. (BCLI) CEO Chaim Lebovits on Q4 2021 Results - Earnings Call Transcript

NEW YORK, March 28, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative disease, announced today that the company President and Chief Medical Officer, Ralph Kern, MD MHSc has been invited to present at the 2022 Virtual Growth Conference, presented by Maxim Group LLC and hosted by M-Vest, on March 28th - 30th   from 9:00 a.m. - 5:00 p.m.

Brainstorm Cell Therapeutics to Participate in the 2022 Virtual Growth Conference Presented by Maxim Group LLC and hosted by M-Vest on March 28th - 30th from 9:00 a.m. - 5:00 p.m.

NEW YORK, March 28, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the fiscal year ended December 31, 2021 and provided a corporate update.     "We began 2022 with strong momentum and Phase 3 data showing that NurOwn® appears to deliver meaningful clinical benefits to ALS patients with less advanced disease," said Chaim Lebovits, Chief Executive Officer.

BrainStorm Cell Therapeutics Announces Full Year 2021 Financial Results and Provides a Corporate Update

NEW YORK, March 14, 2022 /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 fourth quarter and year ended December 31, 2021, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, March 28, 2022.

BrainStorm to Announce Fourth Quarter and Fiscal Year 2021 Financial Results and Provide a Corporate Update

NEW YORK, Feb. 28, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the acceptance of a scientific abstract as a late-breaking oral presentation at the 2022 MDA (Muscular Dystrophy Association) Clinical & Scientific Conference, which is taking place virtually and in-person at the Gaylord Opryland Resort & Convention Center in Nashville, Tennessee from March 13 – 16, 2022. Details on the upcoming oral presentation are provided below.

BrainStorm Cell Therapeutics Abstract Selected as Late-Breaking Presentation at the 2022 MDA Clinical & Scientific Conference

NEW YORK, Feb. 15, 2022 /PRNewswire/ -- Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the Brazilian Patent Office has granted the patent application titled: "A method of generating cells which secrete Brain Derived Neurotrophic Factor (BDNF), Glial Derived Neurotrophic Factor (GDNF), Hepatocyte Growth Factor (HGF) And Vascular Endothelial Growth Factor (VEGF), wherein said cells do not Secrete Nerve Growth Factor (NGF)." The granted claims cover a method of manufacturing MSC-NTF cells (NurOwn®).

Brainstorm Cell Therapeutics Announces Grant of a New Brazilian Patent Covering Methods of Manufacturing NurOwn®

NEW YORK, Jan. 27, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, M.D., MHSc, President and Chief Medical Officer of BrainStorm Cell Therapeutics, will provide a corporate and clinical overview at the 12th Annual California ALS Research Summit, which is being held virtually January 27-28, 2022.

BrainStorm Cell Therapeutics to Present at the 12th Annual California ALS Research Summit

NEW YORK, Jan. 4, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that Ralph Kern, M.D. MHSc, President and Chief Medical Officer of Brainstorm Cell Therapeutics, will provide a corporate and clinical overview at Biotech Showcase™ 2022, to be held virtually January 10-12 and 17-18, 2022.

BrainStorm Cell Therapeutics to Present at Biotech Showcase™ 2022

NEW YORK, Dec. 27, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced plans for a dosing extension of NurOwn® for participants who completed the Expanded Access Protocol (EAP). The U.S. Food and Drug Administration (FDA) recommended that BrainStorm submit an EAP protocol amendment to provide additional dosing for these participants.

FDA Authorizes Further NurOwn® Dosing Under Expanded Access Program

NEW YORK, Dec. 13, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the peer reviewed publication of Phase 3 clinical data in Muscle and Nerve. The paper, entitled "A Randomized Placebo-Controlled Phase 3 Study of Mesenchymal Stem Cells Induced to Secrete High Levels of Neurotrophic Factors in Amyotrophic Lateral Sclerosis," can be found here.

BrainStorm Cell Therapeutics Announces peer reviewed publication of NurOwn's® Phase 3 Study for ALS in Muscle and Nerve

Catalent

NEW YORK and SOMERSET, N.J., Dec. 7, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, and Catalent (NYSE: CTLT), a global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that the technology transfer for NurOwn® manufacturing at Catalent's facility has been finalized.

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