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Brainstorm Cell Therapeutics(BCLI) - 2024 Q3 - Quarterly Results
2024-11-14 21:35
Exhibit 99.1 BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update Conference call planned for later in Q4 2024 to provide updates on NurOwn® program NEW YORK, November 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 prim ...
BrainStorm Cell Therapeutics Announces Third Quarter 2024 Financial Results and Provides Corporate Update
Prnewswire· 2024-11-14 21:30
Core Viewpoint - BrainStorm Cell Therapeutics Inc. is advancing its NurOwn® program for ALS, focusing on a Phase 3b registration trial, with updates expected in Q4 2024 [1][6]. Company Updates - The company has refined the Phase 3b trial design based on previous study learnings to enhance the likelihood of demonstrating treatment efficacy [2]. - A Memorandum of Understanding (MOU) was signed with Pluri Inc. for the manufacturing of NurOwn® for the upcoming trial [3]. - The Phase 3b trial is expected to enroll approximately 200 ALS participants, with a two-part structure involving both placebo and NurOwn treatments [4]. Clinical Trial Details - The trial will consist of a 24-week Part A with three doses of either NurOwn or placebo, followed by a 24-week open-label Part B where all participants will receive NurOwn [4]. - Primary efficacy will be measured using the ALSFRS-R score, with additional assessments including survival rates and various clinical measures [4]. Financial Performance - As of September 30, 2024, the company reported cash and cash equivalents of approximately $0.35 million, a decrease from $1.3 million year-over-year [7]. - Research and development expenses for Q3 2024 were $1 million, down from $3.3 million in Q3 2023, while general and administrative expenses decreased to $2 million from $2.7 million [7]. - The net loss for Q3 2024 was $2.7 million, compared to a net loss of $1.2 million in the same quarter of 2023 [7]. Long-Term Benefits and Biomarkers - Promising long-term survival benefits were observed in patients treated with NurOwn, with a median survival time of 46.6 months compared to 41.1 months for matched controls [5]. - Consistent reductions in neurofilament light (NfL) levels were noted, indicating ongoing benefits from extended treatment, which aligns with the understanding of NurOwn's mechanism of action [5].
BrainStorm Cell Therapeutics Presented Positive Survival Data from NurOwn® Expanded Access Program at 2024 Annual NEALS Meeting
Prnewswire· 2024-10-28 10:00
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, wh ...
BrainStorm Cell Therapeutics to Provide Corporate Update on Phase 3b NurOwn® Trial at the 2024 Maxim Healthcare Virtual Summit
Prnewswire· 2024-10-07 11:00
Company Overview - BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for neurodegenerative diseases, specifically targeting amyotrophic lateral sclerosis (ALS) through its NurOwn® technology platform [5] - The company has received Orphan Drug designation status from the U.S. FDA and the European Medicines Agency for the treatment of ALS [5] Upcoming Events - BrainStorm will participate in the 2024 Maxim Healthcare Virtual Summit from October 15 to 17, where CEO Chaim Lebovits will discuss the planned Phase 3b clinical trial for NurOwn® [1][2] - The Fireside Chat is scheduled for October 15 at 9:30 a.m. ET, providing an opportunity to engage with the investment community [1] Clinical Development - The NurOwn® technology platform involves harvesting MSC-NTF cells from ALS patients, which are then manufactured to secrete neurotrophic factors targeting neurodegenerative diseases [3] - The clinical program has provided insights into ALS pathology, disease progression, and treatment, including a comprehensive analysis of biomarkers and genetic data [4] Research and Funding - BrainStorm has completed a Phase 3 trial for ALS, supported by grants from the California Institute for Regenerative Medicine and the ALS Association [5] - The company has also conducted a Phase 2 open-label multicenter trial for progressive multiple sclerosis, backed by the National MS Society [5]
BrainStorm Cell Therapeutics Announces Presentations on NurOwn® at 2024 Annual NEALS Meeting
Prnewswire· 2024-09-24 10:00
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."We look forward to sharing the latest update on NurOwn at this year's NEALS meeting. ...
Brainstorm Cell Therapeutics(BCLI) - 2024 Q2 - Earnings Call Transcript
2024-08-14 16:08
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 T ...
Brainstorm Cell Therapeutics(BCLI) - 2024 Q2 - Quarterly Report
2024-08-14 12:01
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to _____________ Commission File Number 001-36641 BRAINSTORM CELL THERAPEUTICS INC. (Exact name of registrant as specified in ...
Brainstorm Cell Therapeutics(BCLI) - 2024 Q2 - Quarterly Results
2024-08-14 11:15
Exhibit 99.1 BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update 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 c ...
BrainStorm Cell Therapeutics Announces Second Quarter 2024 Financial Results and Provides Corporate Update
Prnewswire· 2024-08-14 11:05
- 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 todayNEW YORK, Aug. 14, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDA ...
BrainStorm Cell Therapeutics to Announce Second Quarter Results and Provide a Corporate Update
Prnewswire· 2024-08-07 10:00
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's Chief Executive Officer, Chaim Lebovits, will present a corporate update after which participant q ...