Full Press Release Details
BrainStorm Cell Therapeutics Announces Third Quarter 2021 Financial
Results and Provides a Corporate Update
BrainStorm remains committed to pursuing the best and most expeditious
path forward to facilitate access to NurOwn for people living with ALS
Presented important new ALS biomarker data at NEALS meeting showing
significant NurOwn-driven changes across neural biomarkers and that treatment response to NurOwn can be predicted in the trial using biomarker
data and innovative statistical models
Expanded leadership by naming Stacy R. Lindborg, PhD, EVP and Chief
Development Officer and appointment of Sidney A. Spector, MD, PhD, as SVP, Global Strategy and Medical Affairs and Kim Thacker, MD, as
SVP, Medical Affairs and Clinical Innovation
Conference call and webcast at 8:00 a.m. Eastern Time today
NEW YORK, Nov. 15, 2021 -- BrainStorm Cell Therapeutics Inc. (NASDAQ:
BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced financial results for the quarter ended
September 30, 2021, and provided a corporate update.
"We made strong progress towards our goal of advancing NurOwn
in ALS and MS over the past months," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "Our productive
discussions with leading clinical experts continue, and we continue to bring forward new evidence of NurOwn's effectiveness in the scientific
domain, as highlighted by our recent NEALS presentation of Phase 3 ALS data showing that NurOwn drove significant changes in important
neural biomarkers that could be used to predict treatment outcomes within the trial. The insights we have gained from these discussions
have generated strong momentum in our pursuit of the best and most expeditious path forward to bring NurOwn to patients. We also strengthened
our leadership team and increased our manufacturing capacity, supporting our readiness to provide broad patient access as we seek paths
for potential regulatory approval. The devastating and progressive nature of ALS creates an urgent unmet need for patients, and one that
we are fully committed to addressing through NurOwn's continued advancement."
Third Quarter 2021 and Subsequent Corporate Highlights
Financial Results for the Three Months Ended September 30,
Cash, cash equivalents, and short-term bank deposits were approximately
$28 million as of September 30, 2021, compared to approximately $35 million on June 30, 2021.
Research and development expenses, for the three months ended September 30,
2021 and 2020 were approximately $3.6 million and $4.1 million, respectively.
General and administrative expenses for the three months ended September 30,
2021 and 2020 were approximately $1.7 million and $2.6 million, respectively.
Net loss for the three months ended September 30, 2021 was approximately
$5.3 million, as compared to a net loss of approximately $4.5 million for the three months ended September 30, 2020.
Net loss per share for the three months ended September 30, 2021
and 2020 was $0.15 and $0.14, respectively.
Conference Call and Webcast
| Monday, November 15, 2021, at 8:00 a.m. Eastern Time | |
| From the U.S.: | 888-506-0062 |
| International: | 973-528-0011 |
| Entry Code: | 837509 |
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.
| From the U.S.: | 877-481-4010 |
| International: | 919-882-2331 |
| Replay Passcode: | 43351 |
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).
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.
LifeSci Advisors, LLC
Phone: +1 617-429-3548
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| U.S. $ in thousands | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 25,695 | $ | 37,829 | ||||
| Short-term deposit (Note 4) | 2,114 | 4,107 | ||||||
| Other accounts receivable | 85 | 304 | ||||||
| Prepaid expenses and other current assets (Note 5) | 50 | 1,002 | ||||||
| Total current assets | 27,944 | 43,242 | ||||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | 32 | 26 | ||||||
| Operating lease right of use asset (Note 6) | 5,338 | 6,872 | ||||||
| Property and Equipment, Net | 1,224 | 1,119 | ||||||
| Total Long-Term Assets | 6,594 | 8,017 | ||||||
| Total assets | $ | 34,538 | $ | 51,259 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,739 | $ | 5,417 | ||||
| Accrued expenses | 387 | 1,261 | ||||||
| Operating lease liability (Note 6) | 1,735 | 2,655 | ||||||
| Other accounts payable | 985 | 1,900 | ||||||
| Total current liabilities | 5,846 | 11,233 | ||||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 3,766 | 4,562 | ||||||
| Total long-term liabilities | 3,766 | 4,562 | ||||||
| Total liabilities | $ | 9,612 | $ | 15,795 | ||||
| Stockholders' Equity: | ||||||||
| Stock capital: (Note 7) | 12 | 12 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2021 and December 31, 2020 respectively; Issued and outstanding: 36,277,953 and 35,159,977 shares at September 30, 2021 and December 31, 2020 respectively. | ||||||||
| Additional paid-in-capital | 192,384 | 184,655 | ||||||
| Treasury stocks | (116 | ) | (116 | ) | ||||
| Accumulated deficit | (167,354 | ) | (149,087 | ) | ||||
| Total stockholders' equity | 24,926 | 35,464 | ||||||
| Total liabilities and stockholders' equity | $ | 34,538 | $ | 51,259 |
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands
| Nine months ended | Three months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Unaudited | Unaudited | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net (Note 8) | $ | 11,558 | $ | 13,509 | $ | 3,618 | $ | 1,867 | ||||||||
| General and administrative | 6,769 | 6,684 | 1,659 | 2,618 | ||||||||||||
| Operating loss | (18,327 | ) | (20,193 | ) | (5,277 | ) | (4,485 | ) | ||||||||
| Financial expenses (income), net | (60 | ) | (197 | ) | 59 | 3 | ||||||||||
| Net loss | $ | (18,267 | ) | $ | (19,996 | ) | $ | (5,336 | ) | $ | (4,488 | ) | ||||
| Basic and diluted net loss per share from continuing operations | $ | (0.51 | ) | $ | (0.70 | ) | $ | (0.15 | ) | $ | (0.14 | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 36,140,130 | 28,695,540 | 36,304,878 | 31,154,101 |