BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the financial results for the first quarter ended March 31, 2022 and provided a corporate update.
| BrainStorm continues to gain insights and perspectives from leading ALS experts as it seeks the optimal path forward to provide broad patient access to NurOwn® Strengthened executive team in preparation for anticipated growth and corporate development, with the appointment of Netta Blondheim-Shraga, PhD, as VP of Research & Development and Antal Pearl-Lendner, Avd, as Chief Legal Counsel Conference call and webcast at 8:00 a.m. Eastern Time today NEW YORK, May 16, 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 first quarter ended March 31, 2022 and provided a corporate update. 
“We remain firmly committed to addressing the urgent needs of ALS patients by working expeditiously towards our goal of enabling broad access to NurOwn®,” said Chaim Lebovits, Chief Executive Officer. “Our efforts here are bolstered by peer-reviewed Phase 3 data that provide evidence of NurOwn’s greater treatment effects for ALS patients with less advanced disease, and by our ongoing interactions with the broader physician and patient community. These have allowed us to gain valuable perspective from the world’s most prominent thought leaders as we seek NurOwn’s optimal path forward. Looking ahead, we will continue to leverage expert feedback as we work with the regulatory authorities to enable NurOwn’s advancement. We believe our strong clinical and biomarker data and highly talented leadership team has us poised for sustained success.” First Quarter 2022 and Recent Highlights
Financial Results for the First Quarter Ended March 31, 2022 Cash, cash equivalents, and short-term bank deposits were approximately $18.4 million as of March 31, 2022, compared to $22.1 million as of December 31, 2021. Research and development expenses for the three months ended March 31, 2022, and 2021 were approximately $2.6 million and $4.3 million, respectively. General and administrative expenses for the three months ended March 31, 2022, and 2021 were approximately $2.9 million and $2.6 million, respectively. Net loss for the three months ended March 31, 2022, was approximately $5.4 million, as compared to a net loss of approximately $6.7 million for the three months ended March 31, 2021. Net loss per share for the three months ended March 31, 2022, and 2021 was $0.15 and $0.19 respectively. Conference Call and Webcast May 16, 2022, at 8:00 a.m. Eastern Time
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.
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 multiple sclerosis (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 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. CONTACTS Investor Relations: Media:
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Company Codes: NASDAQ-SMALL:BCLI | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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