Full Press Release Details
BrainStorm Announces Financial Results
for the Third Quarter of 2020 and Provides a Corporate Update
Pivotal Phase 3 ALS trial remains on
track for top-line data readout by the end of November 2020
New senior executives strengthen regulatory
and market access capabilities as the Company prepares to transition to a commercial organization
Conference Call and Webcast at 8 a.m.
NEW YORK, October 15, 2020 -- BrainStorm
Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, announced today
financial results for the third quarter ended September 30, 2020, and provided a corporate update.
"The most important near-term event
for BrainStorm will be the upcoming top-line data readout for the NurOwn Phase 3 trial in ALS, expected by the end of November.
A successful outcome will set us on the path to filing a Biologic License Application (BLA) for what we believe will be a valuable
new treatment for ALS," said Chaim Lebovits, Chief Executive Officer of BrainStorm Cell Therapeutics. "In parallel
to our preparations for upcoming data read out, we are very busy planning and executing on other pre-BLA activities. On the management
front, we appointed William K. White and Dr. Anthony Waclawski, adding valuable commercial and regulatory expertise to our leadership
team. This expertise will be crucial as we work towards obtaining regulatory approval for NurOwn and ensuring that, if approved,
it will be readily accessible to ALS patients in need of new treatment options for this devastating disease."
NurOwn has an innovative mechanism of action
that is broadly applicable across neurodegenerative diseases and BrainStorm continues to invest in clinical trials evaluating the
product in conditions beyond ALS to maximize value creation for its various stakeholders. The company remains on track to complete
dosing in its Phase 2 clinical trial in progressive multiple sclerosis (PMS) by the end of 2020. In addition, the Company recently
unveiled a clinical development program in Alzheimer's' disease (AD) and is planning a Phase 2 proof-of-concept clinical
trial at several leading AD centers in the Netherlands and France.
Third Quarter 2020 and Recent Corporate Highlights:
Presented at the following Investor Conferences:
Cash and Liquidity as of October 14, 2020
Total available funding as of October 14,
2020, which includes cash, cash equivalents and short-term bank deposits of approximately $33.1 million as well as remaining non-dilutive
funding from CIRM, IIA and other grants, amounts to approximately $36 million.
Financial Results for the Three Months Ended September 30,
Conference Call & Webcast
Thursday, October 15, 2020 at 8 a.m. Eastern Time
From the US: 877-407-9205
International: 201-689-8054
Replays, available through October 29, 2020
From the US: 877-481-4010
International: 919-882-2331
Replay Passcode: 37811
(autologous MSC-NTF) cells represent 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 can 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 has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment
of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA)
to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and completed enrollment in August
About BrainStorm Cell Therapeutics Inc.
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 fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056),
investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California
Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA
approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a 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 enrollment in August 2020. For more information, visit the company's website at www.brainstorm-cell.com.
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, 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 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,; 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. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| September 30, | December 31, | |||||||
| 2020 | 2019 | |||||||
| U.S. $ in thousands | ||||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 24,770 | $ | 536 | ||||
| Short-term deposit (Note 4) | 4,038 | 33 | ||||||
| Other accounts receivable | 1,473 | 2,359 | ||||||
| Prepaid expenses and other current assets (Note 5) | 56 | 432 | ||||||
| Total current assets | 30,337 | 3,360 | ||||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | 27 | 32 | ||||||
| Operating lease right of use asset (Note 6) | 1,377 | 2,182 | ||||||
| Property and Equipment, Net | 950 | 960 | ||||||
| Total Long-Term Assets | 2,354 | 3,174 | ||||||
| Total assets | $ | 32,691 | $ | 6,534 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 3,283 | $ | 14,677 | ||||
| Accrued expenses | 917 | 1,000 | ||||||
| Operating lease liability (Note 6) | 1,216 | 1,263 | ||||||
| Other accounts payable | 1,013 | 714 | ||||||
| Total current liabilities | 6,429 | 17,654 | ||||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 284 | 1,103 | ||||||
| Total long-term liabilities | 284 | 1,103 | ||||||
| Total liabilities | $ | 6,713 | $ | 18,757 | ||||
| Stockholders' Equity (deficit): | ||||||||
| Stock capital: (Note 7) | 12 | 11 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at September 30, 2020 and December 31, 2019 respectively; Issued and outstanding: 31,567,592 and 23,174,228 shares at September 30, 2020 and December 31, 2019 respectively. | ||||||||
| Additional paid-in-capital | 163,238 | 105,042 | ||||||
| Receipts on account of shares | - | - | ||||||
| Accumulated deficit | (137,272 | ) | (117,276 | ) | ||||
| Total stockholders' equity (deficit) | 25,978 | (12,223 | ) | |||||
| Total liabilities and stockholders' equity | $ | 32,691 | $ | 6,534 |
BRAINSTORM CELL THERAPEUTICS INC. AND
INTERIM CONDENSED CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS
U.S. dollars in thousands
| Nine months ended | Three months ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Unaudited | Unaudited | |||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development, net | $ | 13,509 | $ | 11,018 | $ | 1,867 | $ | 4,008 | ||||||||
| General and administrative | 6,684 | 4,318 | 2,618 | 1,543 | ||||||||||||
| Operating loss | (20,193 | ) | (15,336 | ) | (4,485 | ) | (5,551 | ) | ||||||||
| Financial expenses (income), net | (197 | ) | 225 | 3 | 83 | |||||||||||
| Net loss | $ | (19,996 | ) | $ | (15,561 | ) | $ | (4,488 | ) | $ | (5,634 | ) | ||||
| Basic and diluted net loss per share from continuing operations | $ | (0.70 | ) | $ | (0.72 | ) | $ | (0.14 | ) | $ | (0.25 | ) | ||||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 28,695,540 | 21,630,007 | 31,154,101 | 22,254,993 |