BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs

Rhea-AI Summary

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) has appointed Sidney A. Spector, MD, PhD, and Kim Thacker, MD, to key roles in Global Strategy and Medical Affairs, as part of its growth strategy. Additionally, Stacy Lindborg, PhD, becomes Chief Development Officer. These leadership changes aim to enhance the company's clinical development and regulatory affairs, particularly for the NurOwn^® platform, which is under consideration for regulatory approval for treating neurodegenerative diseases. The company has completed pivotal Phase 3 trials for ALS and is expanding its portfolio.

Positive

• Appointment of experienced leaders to enhance clinical development and regulatory affairs.
• Leadership changes aimed at accelerating growth and innovation.
• Completed Phase 3 pivotal trial for NurOwn^® in ALS.

Negative

• None.

NEW YORK, Nov. 8, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced executive appointments as the company prepares for future growth. Sidney A. Spector, MD, PhD, was named Senior Vice President Global Strategy and Medical Affairs and Kim Thacker, MD, was named Senior Vice President, Medical Affairs and Clinical Innovation. BrainStorm also has expanded the responsibilities of Stacy Lindborg, PhD, Executive Vice President, appointing her to the new position of Chief Development Officer.

These appointments mark an investment in accelerating BrainStorm's progress. Reporting to Ralph Kern, MD, MHSc, President and Chief Medical Officer, Dr. Spector and Dr. Thacker will work together to create a formal global Medical Affairs function as the company prepares for anticipated growth. As Chief Development Officer, Dr. Lindborg will build a leadership team required for development and regulatory affairs to support clinical development in multiple disease areas and technologies. She continues to report to Chaim Lebovits, Chief Executive Officer of BrainStorm.

"We are at a pivotal juncture in the history of BrainStorm Cell Therapeutics," said Mr. Lebovits. "Sid and Kim bring a rich combination of scientific expertise and experience that will be invaluable as we seek potential paths for regulatory approval of NurOwn® and advance our development portfolio of innovative treatments, as we continue to add new leaders with capabilities to complement our already strong team."

Dr. Spector, a physician and scientist with extensive experience in the development of innovative medicines, is Clinical Associate Professor of Neurology at the University of Arizona College of Medicine. Prior to BrainStorm, he was Vice President of U.S. Medical Affairs at AveXis prior to the company's acquisition by Novartis, and remained at Novartis as medical director of clinical development, regulatory submission and launch of Zolgenzma, a gene replacement therapy for spinal muscular atrophy. Dr. Spector was also clinical lead responsible for management of Asia/Pacific clinical development and regulatory submissions in Japan.. Earlier in his career, he held senior roles in CNS drug development at Elan Pharmaceuticals and Pfizer Inc. Dr. Spector earned his medical degree at the University of Tel Aviv Sackler School of Medicine, and his PhD in Kinesiological Sciences at the University of California, Los Angeles. He completed post-doctoral fellowships at the National Institutes of Health, NINCDS in Neuromuscular Diseases and Neurokinesiology. 

Dr. Spector stated: "I've committed my career to developing medicines that have a meaningful impact on patients' lives. I am impressed by BrainStorm's development of such important, potentially best-in-class autologous cellular therapeutics for the treatment of highly debilitating neurodegenerative diseases."

Dr. Thacker is a neurologist, executive and patient advocate with more than twenty years of experience in pharma and biotech. Prior to joining BrainStorm, she was Vice President, Medical Affairs at Urogen Pharma. She also held senior roles at Mesoblast, Forest Research Institute, Sanofi Aventis, Pfizer and Roche Laboratories. She has a successful track record in innovation to support the advancement of human health, particularly related to eldercare and neuroscience and making a meaningful difference in healthcare. She has expertise in clinical development and launches, health economics and outcomes research, neuroethics and neurotechnology and compliance, including multiple publications and 12 product launches. Dr. Thacker earned her medical degree at the State University of New York Health Science Center at Brooklyn. She served an internship in Internal Medicine at Danbury Hospital and residency in Adult Neurology at Long Island Jewish Medical Center, becoming Chief Resident. She also has received training in Bioethics at Columbia University. Dr. Thacker is a Fellow of the New York Academy of Medicine.

Dr. Thacker commented: "I am excited to join BrainStorm's leadership team during such a transformational period for the Company. BrainStorm's unique approaches to the treatment of ALS, MS and other highly debilitating neurodegenerative diseases is grounded in breakthrough scientific innovation."       

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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website at www.brainstorm-cell.com.

Safe-Harbor Statement 

Statements in this announcement other than historical data and information, including statements regarding future NurOwn^® manufacturing and clinical development plans, 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 "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwn^® treatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn^® treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwn^® treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; 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.

Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg

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

Media:
Mariesa Kemble
kemblem@mac.com

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-expands-leadership-team-to-support-clinical-development-and-medical-affairs-301418359.html

SOURCE BrainStorm Cell Therapeutics Inc.

FAQ

What new leadership appointments were announced by BrainStorm Cell Therapeutics on November 8, 2021?

BrainStorm appointed Sidney A. Spector, MD, PhD, as Senior VP of Global Strategy and Medical Affairs, and Kim Thacker, MD, as Senior VP of Medical Affairs and Clinical Innovation, alongside the promotion of Stacy Lindborg, PhD, to Chief Development Officer.

What is the purpose of the new leadership roles at BrainStorm Cell Therapeutics?

The new roles are intended to enhance clinical development and regulatory affairs in preparation for anticipated growth and regulatory approval of the NurOwn^® treatment.

What are the latest clinical trial developments for BrainStorm Cell Therapeutics?

BrainStorm has completed a Phase 3 pivotal trial for its autologous MSC-NTF cells in ALS, which is crucial for potential regulatory approval.

How does the leadership change impact BrainStorm's development pipeline?

The leadership changes are expected to strengthen the company's capabilities in clinical development and regulatory submissions for its neurodegenerative disease therapies.

What challenges does BrainStorm Cell Therapeutics face regarding regulatory approval?

BrainStorm may face challenges related to the successful initiation and completion of product development programs, as well as securing regulatory approvals for its NurOwn^® treatment.