Full Press Release Details
BrainStorm Cell Therapeutics Announces First
Quarter 2022 Financial Results and Provides 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 Blundheim-Shraga, PhD, as VP of Research & Development
and Antal Pearl-Lendener, LLB, as Chief Legal Counsel
Conference call and webcast at 8:00 a.m. Eastern
YORK, May 16, 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 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
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
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: +1 617-429-3548
BRAINSTORM CELL THERAPEUTICS INC. AND
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| March 31, | December 31, | |||||||
| 2022 | 2021 | |||||||
| U.S. $ in thousands | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 15,151 | $ | 18,856 | ||||
| Short-term deposit (Note 4) | 3,246 | 3,238 | ||||||
| Other accounts receivable | 61 | 86 | ||||||
| Prepaid expenses and other current assets (Note 5) | 802 | 1,100 | ||||||
| Total current assets | 19,260 | 23,280 | ||||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | 27 | 27 | ||||||
| Operating lease right of use asset (Note 6) | 5,380 | 4,781 | ||||||
| Property and Equipment, Net | 1,124 | 1,189 | ||||||
| Total Long-Term Assets | 6,531 | 5,997 | ||||||
| Total assets | $ | 25,791 | $ | 29,277 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payables | $ | 4,570 | $ | 3,700 | ||||
| Accrued expenses | 71 | 83 | ||||||
| Operating lease liability (Note 6) | 1,629 | 1,461 | ||||||
| Other accounts payables | 1,102 | 1,073 | ||||||
| Total current liabilities | 7,372 | 6,317 | ||||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 3,932 | 3,618 | ||||||
| Total long-term liabilities | 3,932 | 3,618 | ||||||
| Total liabilities | $ | 11,304 | $ | 9,935 | ||||
| Stockholders' Equity: | ||||||||
| Stock capital: (Note 7) | 12 | 12 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares at December 31, 2021 and March 31, 2022 respectively; Issued and outstanding: 36,486,180 and 36,277,953 shares at September 30, 2021 and December 31, 2020 respectively. | ||||||||
| Additional paid-in-capital | 193,495 | 192,990 | ||||||
| Treasury stocks | (116 | ) | (116 | ) | ||||
| Accumulated deficit | (178,904 | ) | (173,544 | ) | ||||
| Total stockholders' equity | 14,487 | 19,342 | ||||||
| Total liabilities and stockholders' equity | $ | 25,791 | $ | 29,277 |
BRAINSTORM CELL THERAPEUTICS INC. AND
INTERIM CONDENSED CONSOLIDATED STATEMENTS
OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands
| Three months ended | ||||||||
| March 31, | ||||||||
| 2022 | 2021 | |||||||
| Unaudited | ||||||||
| Operating expenses: | ||||||||
| Research and development, net (Note 8) | $ | 2,616 | $ | 4,341 | ||||
| General and administrative | 2,859 | 2,588 | ||||||
| Operating loss | (5,475 | ) | (6,929 | ) | ||||
| Financial income, net | 115 | 267 | ||||||
| Net loss | $ | (5,360 | ) | $ | (6,662 | ) | ||
| Basic and diluted net loss per share from continuing operations | $ | (0.15 | ) | $ | (0.19 | ) | ||
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 36,436,882 | 35,791,309 |