Full Press Release Details
Cell Therapeutics Announces First Quarter 2023 Financial Results and Provides Corporate Update
Biologics License Application for NurOwn for
the treatment of ALS to be subject of an upcoming FDA Advisory Committee Meeting
Conference call and webcast at 8:00 a.m. Eastern
NEW YORK, May 15, 2023 /PRNewswire/
-- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative
diseases, today announced financial results for the quarter ended March 31, 2023 and provided a corporate update.
"We continue to diligently prepare for NurOwn's
upcoming ADCOM supported by a robust dataset providing compelling evidence of its efficacy in ALS, as well as a talented team that was
recently bolstered by the addition of Dr. Kirk Taylor as our EVP, Chief Medical Officer," said Chaim Lebovits, President and Chief
Executive Officer of BrainStorm. "Kirk's appointment is part of a strategic initiative to build our medical, regulatory, advocacy,
and commercial teams as we prepare for anticipated growth and a potential transition to a commercial organization. On the strength of
the data we have generated, and the feedback received from leading ALS experts, we believe we are well positioned to achieve a successful
outcome at the upcoming ADCOM. We recognize that time is of the essence for patients with ALS and remain fully committed to working expeditiously
towards our goal of making NurOwn widely available to those in need."
"We are equally excited by the addition
of Antonio Trejo, VP of Regulatory Affairs, and Robin Wallace, VP of Clinical Operations to our leadership team", said Stacy Lindborg,
Ph.D., co-CEO BrainStorm. "As we add to the depth of expertise and capacity of our entire team we will prioritize activities for
the upcoming ADCOM and additional tasks that will aide FDA approval, while keeping the horizon of opportunities that lay ahead for Brainstorm.
Opportunities such as expanding geographies where NurOwn is approved to treat ALS, expanding the scope of diseases we target as part of
our clinical portfolio for NurOwn, in addition to allowing for the development of our next technology platform based on exosomes. We are
excited about the multitude of upcoming challenges and opportunities that lay ahead."
First Quarter 2023 and Recent Highlights
for the Quarter Ended March 31, 2023
Cash, cash equivalents,
and short-term bank deposits were approximately $2.2 million as of March 31, 2023, compared to $3 million as of December 31, 2022.
Research and development
expenses for the three months ended March 31, 2023 and 2022 were approximately $2.9 million and $2.6 million, respectively.
General and administrative
expenses for the three months ended March 31, 2023 and 2022 were approximately $2.2 million and $2.9 million, respectively.
Net loss for the three
months ended March 31, 2023 was approximately $5.1 million, as compared to a net loss of approximately $5.4 million for the three months
ended March 31, 2022.
Net loss per share for
the three months ended March 31, 2023 and 2022 was $0.14 and $0.15, respectively.
May 15, 2023, at 8:00
Participant Numbers:
Toll Free: 877 545 0523
International: 973 528 0016
Those interested in listening to the conference
call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's
website at https://ir.brainstorm-cell.com/events-and-presentations and clicking on the conference call link.
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
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 MS and was supported by a grant from the National MS
Safe-Harbor Statement
Statements in this announcement
other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDA and the
clinical development of NurOwn as a therapy for the treatment of ALS, 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 "intend," "should," "could," "will,"
"believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements.
The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's
ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of
NurOwn , whether BrainStorm's future interactions with the FDA will have productive outcomes, 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
Phone: +1 202-330-3431
BRAINSTORM CELL THERAPEUTICS INC. AND
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| U.S. $ in thousands | ||||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 2,021 | $ | 772 | ||||
| Short-term deposit (Note 4) | 206 | 2,211 | ||||||
| Other accounts receivable | 44 | 91 | ||||||
| Prepaid expenses and other current assets (Note 5) | 658 | 32 | ||||||
| Total current assets | 2,929 | 3,106 | ||||||
| Long-Term Assets: | ||||||||
| Prepaid expenses and other long-term assets | 23 | 23 | ||||||
| Operating lease right of use asset (Note 6) | 4,054 | 4,389 | ||||||
| Property and Equipment, Net | 866 | 933 | ||||||
| Total Long-Term Assets | 4,943 | 5,345 | ||||||
| Total assets | $ | 7,872 | $ | 8,451 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Current Liabilities: | ||||||||
| Accounts payables | $ | 7,802 | $ | 6,224 | ||||
| Accrued expenses | 171 | 84 | ||||||
| Operating lease liability (Note 6) | 1,389 | 1,427 | ||||||
| Other accounts payables | 1,060 | 1,065 | ||||||
| Total current liabilities | 10,422 | 8,800 | ||||||
| Long-Term Liabilities: | ||||||||
| Operating lease liability (Note 6) | 2,290 | 2,666 | ||||||
| Total long-term liabilities | 2,290 | 2,666 | ||||||
| Total liabilities | $ | 12,712 | $ | 11,466 | ||||
| Stockholders' Equity: | ||||||||
| Stock capital: (Note 7) | 12 | 12 | ||||||
| Common Stock of $0.00005 par value - Authorized: 100,000,000 shares March 31, 2023 and December 31, 2022 respectively; Issued and outstanding: 38,475,251 and 36,694,078 shares at March 31, 2023 and December 31, 2022 respectively. | ||||||||
| Additional paid-in-capital | 198,144 | 194,910 | ||||||
| Treasury stocks | (116 | ) | (116 | ) | ||||
| Accumulated deficit | (202,880 | ) | (197,821 | ) | ||||
| Total stockholders' equity (deficit) | (4,840 | ) | (3,015 | ) | ||||
| Total liabilities and stockholders' equity (deficit) | $ | 7,872 | $ | 8,451 |
The accompanying notes are an integral part of the
consolidated financial statements.