Brainstorm Cell Therapeutics Inc
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Brainstorm Cell Therapeutics Inc
Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. The company is headquartered in New York City, New York and currently employs 43 full-time employees. The company went IPO on 2003-05-28. The firm is focused on the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Progressive Multiple Sclerosis (PMS), Alzheimer's disease (AD), and other neurodegenerative diseases. NurOwn, its cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs), modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function. NurOwn has completed its phase III ALS and phase II PMS clinical trials. Its wholly owned subsidiary, BrainStorm Cell Therapeutics Ltd. holds the rights to commercialize its NurOwn technology. Its other subsidiaries include Advanced Cell Therapies Ltd., and two others.
Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. The company is headquartered in New York City, New York and currently employs 43 full-time employees. The company went IPO on 2003-05-28. The firm is focused on the development and commercialization of autologous cellular therapies for the treatment of neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig's disease), Progressive Multiple Sclerosis (PMS), Alzheimer's disease (AD), and other neurodegenerative diseases. NurOwn, its cell therapy platform, leverages cell culture methods to induce autologous bone marrow-derived mesenchymal stem cells (MSCs) to secrete high levels of neurotrophic factors (NTFs), modulate neuroinflammatory and neurodegenerative disease processes, promote neuronal survival and improve neurological function. NurOwn has completed its phase III ALS and phase II PMS clinical trials. Its wholly owned subsidiary, BrainStorm Cell Therapeutics Ltd. holds the rights to commercialize its NurOwn technology. Its other subsidiaries include Advanced Cell Therapies Ltd., and two others.
Regulatory Progress: The FDA cleared Brainstorm to begin its Phase IIIb ENDURANCE trial for NurOwn in early-stage ALS, providing regulatory clarity through a Special Protocol Assessment.
Trial Delay: Despite being operationally ready, initiation of the Phase IIIb trial is on hold due to lack of funding, as key investors are waiting for FDA feedback on a Citizens petition.
Citizens Petition Impact: A 309-page Citizens petition, filed by ALS patients and families, may influence regulatory review and potentially pave the way for accelerated approval of NurOwn.
Financial Position: As of June 30, 2025, Brainstorm had only $1 million in cash, and posted a net loss of $2.9 million for the quarter, highlighting urgent funding needs.
NASDAQ Delisting: The company was delisted from NASDAQ due to shareholder equity shortfall but aims to regain compliance and relist in the future.
Expanded Access Data: Management highlighted strong long-term survival data from its expanded access program, including patients surviving 5-7 years post-treatment.
Strategic Focus: The company remains committed to advancing NurOwn in ALS and other CNS diseases, but both funding and regulatory signals are critical for next steps.
