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.

-  Presentation by Co-CEO Stacy Lindborg, Ph.D., held at 2023 ALS Drug Development Summit -  Summit Focused On Transforming Translational Tools to Accelerate Future ALS Approvals NEW YORK , May 19, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, joined an international audience of patient advocacy groups, physicians, research organizations, industry representatives, key thought leaders and decision makers dedicated to ALS research, at The 2023 ALS Drug Development summit, through an invited presentation and panel discussion on May 17 and 18, 2023.

BrainStorm Cell Therapeutics Summarizes Key Messages from Its Participation as Expert Speakers in an Invited Presentation and Panel Discussion at The 2023 ALS Drug Development Summit

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q1 2023 Earnings Conference Call May 15, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and CEO Stacy Lindborg - Co-CEO Alla Patlis - Interim CFO Kirk Taylor - EVP and Chief Medical Officer Conference Call Participants David Bautz - Zacks Small-Cap Operator Greetings, and welcome to the Brainstorm Cell Therapeutics First Quarter 2023 Earnings Call. At this time, participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Q1 2023 Earnings Call Transcript

Biologics License Application for NurOwn® for the treatment of ALS to be subject of an upcoming FDA Advisory Committee Meeting Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , May 15, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the quarter ended March 31, 2023 and provided a corporate update.

BrainStorm Cell Therapeutics Announces First Quarter 2023 Financial Results and Provides Corporate Update

NEW YORK , May 9, 2023 /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 First Quarter ended March 31, 2023, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, May 15th.

BrainStorm to Announce First Quarter 2023 Financial Results and Provide a Corporate Update

Dr. Taylor has extensive biopharma industry expertise in neurodegenerative disease and experience leading drug launches and post-approval studies Company begins a targeted capability build to prepare for anticipated growth NEW YORK , April 24, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer (EVP, CMO), effective May 1, 2023.

BrainStorm Cell Therapeutics Strengthens Leadership Team with Appointment of Kirk Taylor, M.D., as Executive Vice President and Chief Medical Officer

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q4 2022 Earnings Conference Call March 30, 2023 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and Chief Executive Officer Stacy Lindborg - Co-Chief Executive Officer Alla Patlis - Interim Chief Financial Officer David Setboun - Chief Operating Officer Conference Call Participants Jason McCarthy - Maxim Group David Bautz - Zacks Small-Cap Research Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Fourth Quarter 2022 Earnings Call. At this time, all participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Q4 2022 Earnings Call Transcript

BrainStorm just announced that it has secured an FDA advisory committee vote for treatment candidate NurOwn for the treatment of ALS. NurOwn's results on biomarker NfL have actually been remarkable good, outperforming Biogen's/Ionis' Tofersen which has its PDUFA date on April 25, 2023.

BrainStorm: Upcoming AdCom Meeting For NurOwn For ALS Could Be Start Of Major Turnaround

Biologics License Application for NurOwn® for the treatment of ALS to be discussed in an upcoming FDA Advisory Committee Meeting Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , March 30, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the fiscal year ended December 31, 2022 and provided a corporate update.

BrainStorm Cell Therapeutics Announces Full Year 2022 Financial Results and Provides a Corporate Update

Conference call and webcast at 8:00 a.m. ET NEW YORK , March 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) will hold an Advisory Committee Meeting ('ADCOM') to discuss the company's Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).

BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn® for the Treatment of ALS

NEW YORK , March 21, 2023 /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 fourth quarter and year ended December 31, 2022, and provide a corporate update, at 8:00 a.m. Eastern Time on Thursday, March 30th.

BrainStorm to Announce Fourth Quarter and Fiscal Year 2022 Financial Results and Provide a Corporate Update

Serum and cerebrospinal fluid samples from the Phase 3 study of NurOwn® in ALS to be donated to the NEALS biorepository for use by the research community NEW YORK , Jan. 10, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that BCLI will donate biospecimens from NurOwn's placebo-controlled Phase 3 ALS trial to the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) biorepository for use by the research community. The specimens are being submitted to the biorepository in connection with a $500,000 grant previously awarded to BrainStorm by The ALS Association and I AM ALS, to support biomarker research.

BrainStorm Cell Therapeutics Partners with NEALS, The ALS Association, and I AM ALS to Provide Public Access to Biospecimens from NurOwn's Phase 3 ALS Study

NEW YORK , Jan. 5, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that Chaim Lebovits, President and CEO, and Stacy Lindborg, Co-CEO, will jointly present a corporate and clinical overview at 10:30 a.m. PT on Monday, Jan. 9 at Biotech Showcase™ 2023 (Hilton San Francisco Union Square, Yosemite A, Ballroom Level).

BrainStorm Cell Therapeutics to Present at Biotech Showcase™ 2023

NEW YORK , Jan. 4, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the promotion of Dr. Stacy Lindborg to the role of Co-Chief Executive Officer. This promotion launches a targeted capability build which will be led by Dr. Lindborg, to hire and bring expertise inside BrainStorm, preparing for success.

BrainStorm Cell Therapeutics Announces Promotion of Dr. Stacy Lindborg to Co-Chief Executive Officer

NEW YORK , Dec. 27, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company's New Biologics License Application (BLA) for NurOwn® for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.

BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn®

Meeting expected to occur within 30 days of the FDA's receipt of the meeting request NEW YORK , Dec. 12, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the company has submitted a Type A Meeting Request to the U.S. Food and Drug Administration (FDA) to discuss the contents of a refusal to file letter previously issued by the FDA regarding the company's New Biologics License Application (BLA) for NurOwn® for the treatment of ALS. The Type A Meeting is expected to occur within 30 days of the FDA's receipt of the meeting request.

BrainStorm Cell Therapeutics Submits Type A Meeting Request to U.S. Food and Drug Administration

NEW YORK , Dec. 5, 2022 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Brainstorm Cell Therapeutics Inc. ("Brainstorm" or the "Company") (NASDAQ: BCLI). Such investors are advised to contact Robert S.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Brainstorm Cell Therapeutics Inc. - BCLI

Brainstorm Cell Therapeutics Inc. (NASDAQ:BCLI ) Q3 2022 Earnings Conference Call November 14, 2022 8:00 AM ET Company Participants Michael Wood - LifeSci Advisors Chaim Lebovits - President and CEO Stacy Lindborg - EVP and Chief Development Officer Ralph Kern - President and Chief Medical Officer Alla Patlis - Interim CFO Conference Call Participants David Bautz - Zacks Small-Cap Daniel Walker - Ness Industries Operator Greetings, and welcome to the Brainstorm Cell Therapeutics Third Quarter 2022 Conference Call. At this time, participants are in a listen-only mode.

Brainstorm Cell Therapeutics Inc. (BCLI) Q3 2022 Earnings Call Transcript

BrainStorm to request Type A meeting with FDA to facilitate NurOwn's advancement following receipt of a refusal to file letter regarding the company's new Biologics License Application Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK , Nov. 14, 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 third quarter ended September 30, 2022, and provided a corporate update.

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

NEW YORK , Nov. 10, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that the company has received a refusal to file letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The FDA has indicated that the company can request a Type A meeting to discuss the content of the refusal to file letter.

BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS

NEW YORK , Nov. 7, 2022 /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 third quarter ended September 30, 2022, and provide a corporate update, at 8:00 a.m. Eastern Time on Monday, November 14, 2022.

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

New post-hoc analyses that account for ALSFRS-R floor effects add to the robust body of evidence supporting a clinically meaningful treatment effect with NurOwn® in ALS NEW YORK , Nov. 7, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the presentation of a poster with new analyses from NurOwn's placebo-controlled Phase 3 amyotrophic lateral sclerosis (ALS) trial that account for limitations in the Revised ALS Functional Rating Scale (ALSFRS-R) and provide evidence of a clinically meaningful treatment effect. The poster, titled, 'Further Analysis of NurOwn Phase 3 Data Based on Baseline ALSFRS-R Status Clarifies Treatment Outcomes' was presented at the 21st Annual NEALS Meeting, taking place in Clearwater Beach, FL and virtually.

BrainStorm Cell Therapeutics Presents New Analyses from NurOwn's Phase 3 ALS Trial at the 21st Annual NEALS Meeting

Biomarker analyses show robust increases in cerebrospinal fluid neuroprotective biomarkers following NurOwn treatment NEW YORK , Oct. 20, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced that a scientific abstract titled 'NurOwn (MSC-NTF) Phase 2 Clinical Trial in Progressive MS: Effects on CSF Neuroprotective Biomarkers' will be presented at the 38th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held from October 26-28 th in Amsterdam, NL.     Cerebrospinal fluid (CSF) biomarker analyses from the phase 2 progressive MS clinical trial demonstrate that intrathecal NurOwn treatment resulted in robust increases in CSF neuroprotective biomarkers, consistent with the proposed mechanism of action, and provide important biological context for the observed clinical trial outcomes.

BrainStorm Cell Therapeutics Presents NurOwn® Phase 2 Progressive MS Biomarker Data at the 38th ECTRIMS Congress

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.

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