Full Press Release Details
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
Announced the peer reviewed publication of the
full analysis of the NurOwn Phase 3 trial in ALS
showing greater treatment effects in participants with less advanced disease
Extended treatment period for NurOwn's
Expanded Access Protocol authorized by the United States Food and Drug Administration
Conference call and webcast at 8:00 a.m. Eastern
YORK, March 28, 2022 - 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
"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
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
| Toll Free: | 888-506-0062 | |
| International: | 973-528-0011 | |
| 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 | |
| International: | 919-882-2331 | |
| 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.
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
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.
Phone: +1 617-429-3548
BRAINSTORM CELL THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| U.S. $ in thousands | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 18,856 | $ | 37,829 | ||||
| Short-term deposit (Note 9) | 3,238 | 4,107 | ||||||
| Other accounts receivable (Note 4) | 86 | 304 | ||||||
| Prepaid expenses and other current assets (Note 5) | 1,100 | 1,002 | ||||||
| Total current assets | $ | 23,280 | $ | 43,242 | ||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | $ | 27 | $ | 26 | ||||
| Operating lease right of use asset (Note 6) | 4,781 | 6,872 | ||||||
| Property and Equipment, Net (Note 7) | 1,189 | 1,119 | ||||||
| Total Long-Term Assets | $ | 5,997 | $ | 8,017 | ||||
| Total assets | $ | 29,277 | $ | 51,259 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payables | $ | 3,700 | $ | 5,417 | ||||
| Accrued expenses | 83 | 1,261 | ||||||
| Operating lease liability (Note 6) | 1,461 | 2,655 | ||||||
| Other accounts payables | 1,073 | 1,900 | ||||||
| Total current liabilities | $ | 6,317 | $ | 11,233 | ||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 3,618 | 4,562 | ||||||
| Total long-term liabilities | $ | 3,618 | $ | 4,562 | ||||
| Total liabilities | $ | 9,935 | $ | 15,795 | ||||
| Stockholders' Equity: | ||||||||
| Stock capital: (Note 10) | 12 | 12 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2021 and December 31, 2020 respectively; Issued and outstanding: 36,401,413 and 35,159,977 shares at December 31, 2021 and December 31, 2020 respectively. | ||||||||
| Additional paid-in-capital | 192,990 | 184,655 | ||||||
| Treasury stocks | (116 | ) | (116 | ) | ||||
| Accumulated deficit | (173,544 | ) | (149,087 | ) | ||||
| Total stockholders' equity | $ | 19,342 | $ | 35,464 | ||||
| Total liabilities and stockholders' equity | $ | 29,277 | $ | 51,259 |
The accompanying notes are an integral part of the consolidated
financial statements.
BRAINSTORM CELL THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
U.S. dollars in thousands
| Year ended | ||||||||
| December 31, | ||||||||
| 2021 | 2020 | |||||||
| U.S. $ in thousands | ||||||||
| Operating expenses: | ||||||||
| Research and development, net (Note 11) | $ | 15,235 | $ | 22,329 | ||||
| General and administrative | 9,304 | 9,355 | ||||||
| Operating loss | (24,539 | ) | (31,684 | ) | ||||
| Financial expenses (income), net | (82 | ) | 127 | |||||
| Net loss | $ | (24,457 | ) | $ | (31,811 | ) | ||
| Basic and diluted net loss per share | $ | (0.68 | ) | $ | (1.07 | ) | ||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 36,181,753 | 29,848,217 |
The accompanying notes are an integral part of the consolidated
financial statements.