• Dr. Dagher has extensive biopharma industry expertise in the development and approval of treatments for challenging neurological and rare diseases

NEW YORK, July 12, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced the appointment of Bob Dagher, MD, as Executive Vice President and Chief Development Officer effective July 17, 2023. Dr. Dagher will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm.  He will be responsible for the portfolio strategy and advancement of clinical development plans towards regulatory approval, including the expansion of NurOwn into new diseases and the translation of pre-clinical research into first-in-human trials. 

"Bob is an important addition to our expanding leadership team to help guide BrainStorm through critical inflection points for NurOwn and our growing pipeline," said Chaim Lebovits, President and CEO of BrainStorm "His background, which includes experience in neurology, psychiatry and rare diseases, provides a high level of scientific credibility and expertise in clinical management and corporate leadership. His personal integrity makes him a perfect cultural fit for our already strong team."

Dr. Dagher joins BrainStorm from Enveric Biosciences where, as Chief Medical Officer, he was responsible for defining the portfolio strategy and advancement of development plans toward regulatory approvals. He began his career in biopharmaceuticals as a medical scientist at GSK, and has served in leadership positions of science and medicine at companies such as Sanofi/Genzyme, and LabCorp/Covance, for more than 20 years. Dr. Dagher earned his medical degree at Bordeaux University and St. Joseph University School of Medicine, serving residencies in psychiatry and internal medicine at Boston University Medical Center. A past Diplomat of the American Board of Neurology and Psychiatry, he is licensed to practice medicine in Massachusetts.

Dr. Dagher commented, "I am delighted to join Brainstorm at such an exciting and important juncture. I believe Brainstorm has an innovative and versatile, industry-leading stem cell technology platform, which can rapidly advance autologous targeted therapeutics from bench to clinical development and eventual commercialization. I feel very fortunate to be joining Brainstorm's world-class team of highly experienced and dedicated professionals and be able to contribute to the important work of bringing advanced treatments to improve the lives of those with serious neurodegenerative diseases."

Dr. Dagher joins BrainStorm at a pivotal time. NurOwn®, the company's lead investigational platform, is currently under review by the U.S. Food and Drug Administration for the treatment of for amyotrophic lateral sclerosis (ALS). NurOwn (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. The FDA will hold an Advisory Committee meeting for the ALS indication on September 27, 2023, with a PDUFA target action date of December 8, 2023.

About BrainStorm Cell Therapeutics Inc. 

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement 

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the clinical development of NurOwn® as a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn®, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

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