Full Press Release Details
BrainStorm Announces Full Year 2020 Financial
Results and Provides a Corporate Update
Company met with the FDA to present
phase 3 data and is in ongoing discussions with the FDA to identify agreed upon regulatory pathways that may support NurOwn's
future approval in ALS
Progressive MS Phase 2 trial remains
on track for top-line data readout in Q1 2021
Conference call and webcast at 8
NEW YORK, February 4, 2021 -- BrainStorm Cell Therapeutics
Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today financial results
for the fiscal year ended December 31, 2020, and provided a corporate update.
"In 2020 we achieved several important company milestones,
the most significant of which was the timely completion of our pivotal Phase 3 ALS trial," said Chaim Lebovits, Chief Executive
Officer of BrainStorm Cell Therapeutics. "The trial generated robust data suggesting that NurOwn has a clinically
meaningful treatment effect and the FDA is actively reviewing these data following a recent meeting with our clinical team. The
unmet needs of ALS patients continue to be our greatest inspiration and foremost priority, and we will keep the market updated
as we receive formal feedback from the FDA and diligently pursue next steps to advance NurOwn's development in this devastating
Mr. Lebovits continued, "Beyond our lead ALS program,
we continue to make progress and are poised for a catalyst rich 2021 for our NurOwn technology platform. In progressive MS, our
Phase 2 top-line data are expected by the end of the first quarter, which we believe will highlight the broad applicability of
NurOwn's mechanism of action (MOA). We plan to further advance our pipeline through our clinical development program in Alzheimer's
disease, a highly prevalent disease with enormous societal impact and limited treatment options. These clinical programs will be
complemented by the expansion of our manufacturing capabilities and advancement of our exosome-based platform technology, which
has demonstrated the potential to treat COVID-19 acute respiratory distress syndrome in a recently published preclinical study.
We believe that execution of these milestones will help move us toward our ultimate goal of addressing the critical unmet needs
of patients with neurodegenerative diseases while simultaneously positioning the company to generate shareholder value."
Fourth Quarter 2020 and Recent Corporate Highlights:
Cash and Liquidity as of January 31, 2021
Total cash and liquidity as of January 31,
2021 was approximately $45.0 million.
Financial Results for the Year Ended
For further details on BrainStorm's
financials, including financial results for the year ended December 31, 2020, refer to the Form 10-K filed with the SEC
Conference Call & Webcast
Thursday, February 4, 2021 at 8 a.m. Eastern Time
| From the US: | 877-407-9205 |
| International: | 201-689-8054 |
| Webcast: | https://cutt.ly/vjBvkTp |
| Replays, available through February 18, 2021 | |
| From the US: | 877-481-4010 |
| International: | 919-882-2331 |
| Replay Passcode: | 39495 |
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 status designation 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 is in active discussions with the FDA to identify
regulatory pathways that may support NurOwn's future approval in ALS. BrainStorm is also conducting an FDA-approved Phase 2 open-label
multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive
MS (NCT03799718) completed dosing in December 2020, and topline results are expected by the end of the first quarter
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 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.
LifeSci Advisors, LLC
Phone: +1 646-465-1138
Phone: + 1.973.713.3768
BRAINSTORM CELL THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| December 31, | ||||||||
| 2020 | 2019 | |||||||
| U.S. $ in thousands | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 37,829 | $ | 536 | ||||
| Short-term deposit (Note 9) | 4,107 | 33 | ||||||
| Other accounts receivable (Note 4) | 304 | 2,359 | ||||||
| Prepaid expenses and other current assets (Note 5) | 1,002 | 432 | ||||||
| Total current assets | 43,242 | 3,360 | ||||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | 26 | 32 | ||||||
| Operating lease right of use asset (Note 6) | 6,872 | 2,182 | ||||||
| Property and Equipment, Net (Note 7) | 1,119 | 960 | ||||||
| Total Long-Term Assets | 8,017 | 3,174 | ||||||
| Total assets | $ | 51,259 | $ | 6,534 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 5,417 | $ | 14,677 | ||||
| Accrued expenses | 1,261 | 1,000 | ||||||
| Operating lease liability (Note 6) | 2,655 | 1,263 | ||||||
| Other accounts payable | 1,900 | 714 | ||||||
| Total current liabilities | 11,233 | 17,654 | ||||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 4,562 | 1,103 | ||||||
| Total long-term liabilities | 4,562 | 1,103 | ||||||
| Total liabilities | $ | 15,795 | $ | 18,757 | ||||
| Stockholders' Equity (deficit): | ||||||||
| Stock capital: (Note 11) | 12 | 11 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2020 and December 31, 2020 respectively; Issued and outstanding: 35,159,977 and 23,174,228 shares at December 31, 2020 and December 31, 2019 respectively. | ||||||||
| Additional paid-in-capital | 184,655 | 105,042 | ||||||
| Treasury stocks | (116 | ) | - | |||||
| Accumulated deficit | (149,087 | ) | (117,276 | ) | ||||
| Total stockholders' equity (deficit) | 35,464 | (12,223 | ) | |||||
| Total liabilities and stockholders' equity | $ | 51,259 | $ | 6,534 |
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, | ||||||||
| 2020 | 2019 | |||||||
| U.S. $ in thousands | ||||||||
| Operating expenses: | ||||||||
| Research and development, net (Note 12) | $ | 22,329 | $ | 17,204 | ||||
| General and administrative | 9,355 | 5,797 | ||||||
| Operating loss | (31,684 | ) | (23,001 | ) | ||||
| Financial expenses, net | 127 | 252 | ||||||
| Net loss | $ | (31,811 | ) | $ | (23,253 | ) | ||
| Basic and diluted net loss per share | $ | (1.07 | ) | $ | (1.06 | ) | ||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 29,848,217 | 21,906,257 |
The accompanying notes are an integral part of the consolidated
financial statements.