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. Dr. Taylor will serve on BrainStorm's executive leadership team reporting to Stacy Lindborg, Ph.D., co-CEO of BrainStorm.

Dr. Taylor will lead the global medical affairs function and launch activities, including product launches, post-approval commercialization efforts and deepening relationships with the medical community. He will also support clinical development and overall corporate strategy, including advancement of the Company's long-term business model.

"Kirk's appointment is the first important step in strengthening a targeted, capability build to expand our medical, regulatory and advocacy teams in preparation for anticipated growth," said Chaim Lebovits, President and CEO of BrainStorm. "His experience as a practicing neurologist and building and leading global medical teams will be an invaluable asset as we work to advance NurOwn to regulatory review with the goal of making it widely available to individuals with ALS. We are thrilled to welcome Kirk to BrainStorm and look forward to the contributions he will make."

BrainStorm Cell Therapeutics is entering a pivotal time, as the company prepares for regulatory review of the company's Biologics License Application (BLA) for NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). On March 27, 2023, BrainStorm announced that the U.S. Food and Drug Administration intends to hold an Advisory Committee meeting to prepares for FDA review of NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

Dr. Taylor remarked, "It is an honor to join BrainStorm. This is an exciting time for the company and the ALS community. I am encouraged by the regulatory flexibility that the FDA has shown these rapidly progressing neurological illnesses, such as ALS, where patients are in dire need of new treatments now. I am confident in the effectiveness of NurOwn and grateful for the opportunity to review the full body of clinical evidence with the entire stakeholder community. Time is of the essence for people with ALS and I am ready to hit the ground running."

Dr. Taylor has more than 26 years of experience in global drug development programs, from Phase 1 through post-approval studies, across multiple therapeutic areas including neurology and rare diseases. He is joining BrainStorm from EMD Serono (a Merck KGaA, Darmstadt, Germany company), where, as Senior Vice President, North American Medical Affairs, he led the medical team's efforts across four therapeutic areas and the launch of three new treatments. Prior to EMD Serono, Dr. Taylor served as Senior Vice President, Medical Affairs Strategy and Operations at Verastem Oncology and CMO and Chief of Strategy and Late Phase Development at Finch Therapeutics Group, where he created a plan for filing and commercializing the company's internal assets. Earlier in his career, Dr. Taylor held high-prominent medical roles at companies such as Biogen, Pfizer and Sanofi-Genzyme.

Dr. Taylor holds a B.A. from Harvard University and a M.D. from University of New York Downstate Health Sciences University. He completed a neurology residency at the Albert Einstein College of Medicine and  a postdoctoral fellowship in pain management at the University of California, San Francisco. He taught pain management to neurology residents while on faculty at Yale VA Hospital for two years. He also completed executive leadership training at Harvard, Stanford and INSEAD business schools.

About NurOwn®

The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

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

Investor Relations: 
John Mullaly
LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com

Media: 
Lisa Guiterman 
Phone: +1 202-330-3431
lisa.guiterman@gmail.com  

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SOURCE BrainStorm Cell Therapeutics Inc.