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.

Conference call planned for later in Q4 2024 to provide updates on NurOwn® program NEW YORK , Nov. 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the third quarter ended September 30, 2024 and provided a corporate update. "BrainStorm's primary focus continues to be preparing for the upcoming Phase 3b registration trial of NurOwn in ALS," said Chaim Lebovits, President and CEO of Brainstorm.

BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update

Pluri Inc

Memorandum of Understanding has been signed NEW YORK , Nov. 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it has entered into a Memorandum of Understanding (MOU) with Pluri Inc. (NASDAQ: PLUR) through its wholly owned subsidiary ("Pluri"), an established global leader in the development and manufacturing of cell-based therapeutics, to manufacture NurOwn® for use in BrainStorm's planned Phase 3b trial in amyotrophic lateral sclerosis (ALS). This MOU enables BrainStorm to begin transfer of its manufacturing technology and start producing NurOwn at Pluri's manufacturing facility upon finalizing the binding definitive agreement.

BrainStorm Cell Therapeutics and Pluri Partner to Support NurOwn® Phase 3b Trial Manufacturing

NEW YORK , Oct. 30, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that on October 29, 2024, the Company received written notice from The Nasdaq Stock Market stating that the Company has regained compliance with the minimum closing bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Accordingly, the Company's common stock will continue to trade on The Nasdaq Capital Market, subject to the Company's compliance with Nasdaq's continued listing requirements.

BrainStorm Cell Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

Biomarker data suggest ALS patients may benefit from longer-term treatment with NurOwn Poster highlighting design of planned Phase 3b NurOwn trial also presented NEW YORK , Oct. 28, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the presentation of two posters featuring NurOwn® (MSC-NTF0 or debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting, which took place virtually October 21 – 24. The posters 'Debamestrocel Long-Term Benefits on Survival and Neurodegeneration in ALS Expanded Access Program' and 'An Overview of The Phase 3b Clinical Trial of Debamestrocel in ALS' highlight the results achieved with ALS patients who participated in the Expanded Access Program (EAP) for NurOwn and summarize the details of BrainStorm's upcoming Phase 3b trial in ALS.

BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS Meeting

NEW YORK , Oct. 7, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ:BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced its participation in the 2024 Maxim Healthcare Virtual Summit. Chaim Lebovits, President and CEO of BrainStorm, will join Jason McCarthy, Ph.D.

BrainStorm Cell Therapeutics to Provide Corporate Update on Phase 3b NurOwn® Trial at the 2024 Maxim Healthcare Virtual Summit

NEW YORK , Sept. 24, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the acceptance of two abstracts featuring NurOwn® (MSC-NTF or Debamestrocel) at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis Consortium (NEALS) Meeting, to take place October 21 - 24, in-person in Clearwater, Florida and virtually.

BrainStorm Cell Therapeutics Announces Presentations on NurOwn® at 2024 Annual NEALS Meeting

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q2 2024 Earnings Conference Call August 14, 2024 8:30 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and CEO Alla Patlis - Interim Chief Financial Officer Haro Hartounian - Chief Operating Officer Bob Dagher - Chief Medical Officer Conference Call Participants Joanne Lee - Maxim Group David Bautz - Zacks Small-Cap Research Christopher Nicholson - ACF Equity Research Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Second Quarter 2024 Conference Call. At this time, participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Q2 2024 Earnings Call Transcript

- Company reached alignment with the U.S. FDA on the Chemistry, Manufacturing, and Controls (CMC) aspects of its planned Phase 3b clinical trial for NurOwn® in ALS - SPA in place for Phase 3b NurOwn® trial in ALS - Enhanced leadership team with appointment of  Hartoun Hartounian Ph.D. as EVP and Chief Operating Officer, and promotion of Dr. Bob Dagher to EVP and Chief Medical Officer - Conference call and webcast at 8.30am ET today NEW YORK , Aug. 14, 2024 /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, 2023 and provided a corporate update.

BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update

NEW YORK , Aug. 7, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2024, and provide a corporate update, at 8:30 a.m. Eastern Time on Wednesday, August 14, 2024.

BrainStorm Cell Therapeutics to Announce Second Quarter Results and Provide a Corporate Update

ACF Equity Research  FROM ACF EQUITY RESEARCH HEALTHCARE TEAM LONDON , July 24, 2024 /PRNewswire/ --  NASDAQ: BCLI READ ACF EQUITY RESEARCH'S UPDATE NOTE HERE  READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS & ALS/MND/LOU GEHRIG'S HERE UPDATE NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) develops NurOwn® stem cell therapy for Neurodegenerative diseases (NDDs) – BCLI's first target is ALS (MND/Lou Gehrig's). Since initiation – PIIIb rollout begins.

BCLI Update - Progress Supports Our 10x Plus Value Range Potential

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Corporate Mid-Year Update on NurOwn Program July 8, 2024 8:00 AM ET Company Participants Joyce Lonergan - LifeSci Advisors Chaim Lebovits - President and Chief Executive Officer Haro Hartounian - Executive Vice President, Chief Operating Officer Bob Dagher - Executive Vice President, Chief Medical Officer Conference Call Participants Jason McCarthy - Maxim Group David Bautz - Zachs Small Cap Research Operator Greetings and welcome to the Brainstorm Cell Therapeutics Mid-Year 2024 Conference Call. At this time, all participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Corporate Mid-Year Update on NurOwn Program (Transcript)

A conference call and webcast will be held Monday, July 8, at 8:00 a.m. Eastern Time NEW YORK , July 1, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced today that it will hold a mid-year corporate update to discuss recent positive developments in the NurOwn® program on Monday, July 8, at 8:00 a.m.

BrainStorm Cell Therapeutics to Provide Corporate Mid-Year Update on NurOwn Program

NEW YORK , June 27, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) (the "Company"), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it has entered into a securities purchase agreement with a single institutional investor (the "Holder") for the purchase and sale of 11,111,111 shares of the Company's common stock (or prefunded warrants in lieu thereof) at a purchase price of $0.36 per share in a registered direct offering. In a concurrent private placement, the Company has also agreed to issue and sell unregistered warrants to purchase up to an aggregate of 16,666,667 shares of its common stock.

BrainStorm Cell Therapeutics Announces Pricing of $4.0 Million Registered Direct Offering

NEW YORK , June 26, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced it has reached alignment with the U.S. Food and Drug Administration (FDA) on the Chemistry, Manufacturing, and Controls (CMC) aspects of Brainstorm's Phase 3b clinical trial for NurOwn®, its investigational therapy for amyotrophic lateral sclerosis (ALS).     This Type C meeting builds upon the positive momentum established in April 2024, when the FDA granted BrainStorm a Special Protocol Assessment (SPA) agreement for its NurOwn Phase 3b trial.

BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn® Clinical Trial

Appointment Completes Executive Readiness for Registrational Phase 3b ALS Study Launch NEW YORK , June 20, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the appointment of Hartoun Hartounian Ph.D. as its new EVP and COO, effective as of June 18, 2024.

BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer

FROM ACF EQUITY RESEARCH HEALTHCARE TEAM NASDAQ: BCLI READ ACF EQUITY RESEARCH'S INITIATION NOTE HERE  READ ACF EQUITY RESEARCH'S RELATED THEMATIC RESEARCH NOTE ON REGENERATIVE MEDICINE – NEURODEGENERATIVE DISEASE STEM CELLS & ALS/MND/LOU GEHRIG'S HERE LONDON , June 14, 2024 /PRNewswire/ --  INITIATION NOTE: BrainStorm Cell Therapeutics Inc. (Nasdaq: BCLI) is focused on developing autologous mesenchymal stem cell (MSC) therapies for the treatment of neurodegenerative diseases (NDDs) – BCLI's primary target is the fatal amyotrophic lateral sclerosis (ALS/MND/Lou Gehrig's). Post hoc analysis of BCLI's PIII trial data shows BCLI's NurOwn® (debamestrocel, MSC-NTF), has statistically significant clinical effects on early-stage ALS sufferers and that placebo trialists deteriorate faster.

BCLI: Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation

The data will be presented at the Annual ALS Drug Development Summit, which is focused on identifying transformative ALS targets, seeking translational biomarkers and propelling more clinical approvals NEW YORK , May 20, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, will present new biomarker data suggesting that ALS patients may benefit from longer-term treatment with debamestrocel (NurOwn®). The Company will share the data with an international audience of patient advocacy groups, physicians, research organizations, industry representatives, key thought leaders and decision makers dedicated to ALS research at The 3rd Annual ALS Drug Development Summit, to take place May 21 to 23, 2024 in Boston MA.

BrainStorm Cell Therapeutics to Present New Biomarker Data Suggesting ALS Patients May Benefit From Longer-Term Treatment with NurOwn

Company received written agreement from the U.S. FDA under a Special Protocol Assessment (SPA) on the design for a Phase 3b trial of NurOwn® Conference call planned for later this quarter to provide update on NurOwn program NEW YORK , May 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the First Quarter ended March 31, 2024 and provided a corporate update. "We recently achieved an important milestone on our Debamestrocel (NurOwn®) development program, reaching agreement with the US FDA on a Special Protocol Assessment for our planned Phase 3b trial of NurOwn.

BrainStorm Cell Therapeutics Announces First Quarter 2024 Financial Results and Provides Corporate Update

Bob Dagher, MD, Promoted to Chief Medical Officer Dr. Stacy Lindborg Stepping Down as Co-CEO and Transitioning to Board of Directors   NEW YORK , April 16, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. In addition, after four years of maintaining top executive roles, Dr. Stacy Lindborg stepping down from the role of Co-CEO and will remain with BrainStorm as a member of its Board of Directors.

BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn

NEW YORK , April 11, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI, "the Company"), a leading developer of cellular therapies for neurodegenerative diseases, today announced that it received a notification letter (the "Notification Letter on Compliance") on April 10, 2024 from the Listing Qualifications Department of The Nasdaq Stock Market ("Nasdaq"), indicating that the Company has regained compliance with the minimum market value of listed securities requirement set forth under Nasdaq Listing Rule 5550(b)(2) (the "Rule"). According to the Notification Letter on Compliance, Nasdaq's staff has determined that for the 11 consecutive business days, from March 22, 2024 through April 9, 2024, the Company's market value of listed securities has been $35,000,000 or greater, and the Company has regained compliance with the Rule.

BrainStorm Cell Therapeutics Regains Compliance with NASDAQ Minimum Market Value Rule

NurOwn treatment resulted in a positive impact on important CSF biomarkers relevant to ALS compared to placebo.Significant changes in multiple ALS disease pathways support NurOwn's mechanism of action and complement clinical effects observed in ALS. NEW YORK , April 10, 2024 /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 biomarker data in Muscle and Nerve.

BrainStorm Cell Therapeutics Announces Peer-reviewed Publication of Biomarker Data from NurOwn's® Phase 3 Clinical Trial in ALS

Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

A conference call and webcast will be held Tomorrow, April 9, at 8:00 a.m. Eastern Time NEW YORK , April 8, 2024 /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 the NurOwn® program tomorrow, April 9, at 8:00 AM Eastern Time.

BrainStorm Cell Therapeutics to Provide Update on NurOwn Program

Conference call planned for early April 2024 to provide update on NurOwn program NEW YORK , April 1, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the full year ended December 31, 2023 and provided a corporate update. "Brainstorm's priority for 2024 is to move forward with a confirmatory Phase 3b trial for NurOwn that will potentially support a new Biologics License Application," said Chaim Lebovits, President and Chief Executive Officer of BrainStorm.

BrainStorm Cell Therapeutics Announces Full Year 2023 Financial Results and Provides Corporate Update

Planned Phase 3b trial Designed to Confirm Efficacy and Safety  of NurOwn in mild-to-moderate ALS patients NEW YORK , Feb. 27, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it will present a poster (#M201) outlining the proposed design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS) at the MDA Clinical and Scientific Conference, on Monday, March 4 between 6-8 p.m. at the Hilton Orlando Hotel, Florida.

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