BrainStorm Cell Therapeutics Announces Full Year 2021 Financial Results and Provides a Corporate Update
BrainStorm continues to collect and leverage expert feedback as it pursues the optimal path forward to provide broad access to NurOwn® for patients with ALS
NEW YORK, March 28, 2022 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the fiscal year ended December 31, 2021 and provided a corporate update.
"We began 2022 with strong momentum and Phase 3 data showing that NurOwn® appears to deliver meaningful clinical benefits to ALS patients with less advanced disease," said Chaim Lebovits, Chief Executive Officer. "These data have been validated through a manuscript reviewed and accepted by a prestigious peer-reviewed journal and feedback from key opinion leaders at numerous medical conferences. The insights gained from these interactions are invaluable as we pursue the optimal path forward to provide broad access to NurOwn for patients with ALS. We also took important steps to increase our manufacturing capacity and made key additions to our leadership team in preparation for anticipated growth and success. Looking ahead, we believe we are well positioned to execute on our clinical, regulatory, and corporate goals as we pursue NurOwn's continued advancement in ALS and progressive multiple sclerosis (PMS)."
Fourth Quarter 2021 and Recent Highlights
Financial Results for the Year Ended December 31, 2021
Cash, cash equivalents, and short-term bank deposits were approximately $22.1 million as of December 31, 2021, compared to $41.9 million as of December 31, 2020.
Research and development expenses for the twelve months ended December 31, 2021, and 2020 were approximately $15.2 million and $22.3 million, respectively.
General and administrative expenses for the twelve months ended December 31, 2021, and 2020 were approximately $9.3 million and $9.4 million, respectively.
Net loss for the twelve months ended December 31, 2021, was approximately $24.5 million, as compared to a net loss of approximately $31.8 million for the twelve months ended December 31, 2020.
Net loss per share for the twelve months ended December 31, 2021, and 2020 was $0.68 and $1.07, respectively.
Conference Call and Webcast
Monday March 28, 2022, at 8:00 a.m. Eastern Time
Toll Free: 888-506-0062
Entry Code: 108732
Webcast URL: https://bit.ly/3vITeFB
Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.
Toll Free: 877-481-4010
Replay Passcode: 44771
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.
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).
Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, 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, prospects for future regulatory approval of BrainStorm's NurOwn® treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our products and 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 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; 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.
SOURCE BrainStorm Cell Therapeutics Inc
Company Codes: NASDAQ-SMALL:BCLI, Stuttgart:GHDN, Munich:GHDN, Berlin:GHDN, Frankfurt:GHDN