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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
March 31, 2026
Brainstorm Cell Therapeutics Inc.
(Exact name of registrant as specified in its
charter)
| Delaware |
|
001-36641 |
|
20-7273918 |
(State or other jurisdiction of
incorporation) |
|
(Commission File No.) |
|
(IRS Employer Identification No.) |
| 1325 Avenue of Americas, 28th Floor |
|
| New York, NY |
10019 |
| (Address of principal executive offices) |
(Zip Code) |
(201) 488-0460
(Registrant’s telephone number, including
area code)
N/A
(Former name or former address, if changed
since last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
| Common Stock, $0.00005 par value |
BCLI |
OTCQB Venture Market
(OTCQB) |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition.
On March 31, 2026, Brainstorm Cell Therapeutics
Inc. issued a press release announcing its financial results for the year ended December 31, 2025. The full text of the press release
is being furnished as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.
The information in this Item 2.02, including
Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference
in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in
such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release issued by Brainstorm Cell Therapeutics Inc. on March 31, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
BRAINSTORM CELL THERAPEUTICS INC. |
| |
|
|
| Date: March 31, 2026 |
By: |
/s/ Chaim Lebovits |
| |
|
Chaim Lebovits |
| |
|
President and Co-Chief Executive Officer |
Exhibit 99.1
BrainStorm Cell Therapeutics Announces Full
Year 2025 Financial Results and Provides Corporate Update
Strategic $2.0 million post year-end financing
and re-rating of BCLI shares underscore market confidence
Company highlights durable long-term survival in
Expanded Access Program (EAP) cohort supporting Phase 3b patient selection and inclusion criteria
NEW YORK, March 31, 2026 /PRNewswire/
-- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases,
today announced financial results for the full year ended December 31, 2025, and provided a corporate update.
“Our main priority continues to be advancing
NurOwn into a Phase 3b confirmatory study, having received clearance from the FDA in 2025 for the planned study,” said Chaim Lebovits,
President and CEO. “This study is designed to generate confirmatory data to support a potential BLA submission. Having completed
key regulatory steps, the SPA, CMC alignment, and the May 2025 FDA clearance, we believe we have addressed some of the primary hurdles
in our development program and positioned the company for success. Our network of leading clinical sites are on standby, and we remain
actively engaged with regulators. Further, we believe that the $2.0 million in strategic financing secured in early 2026 has served as
the catalyst for our recovery, resulting in a significant re-rating of our shares and providing the cash runway to execute on key operational
activities. ALS is a devastating disease with limited treatment options, and we remain committed to the ALS community as we work to complete
development of NurOwn and make it available to patients.”
Recent Highlights
NurOwn (MSC-NTF) for ALS
| · | Company continues to execute on operational,
clinical and manufacturing activities to support the Phase 3b ENDURANCE study of NurOwn. The planned study is expected to enroll approximately
200 participants at leading ALS centers and is designed as a two-part trial consisting of a 24-week randomized, double-blind, placebo-controlled
portion (Part A), followed by a 24-week open-label extension (Part B) to further assess long-term safety and durability of effect.
The primary efficacy endpoint for Part A will be change from baseline to Week 24 on the ALSFRS-R. If successful, the Company believes
these data could support a potential BLA submission. Further trial details are posted on ClinicalTrials.gov ID NCT06973629. |
| · | A Citizen Petition was filed with the FDA
by representatives of the ALS community. The petition requests a renewed regulatory review of the data supporting NurOwn. BrainStorm
acknowledges the petition as a constructive development that underscores the continued interest in NurOwn's potential therapeutic value.
The Company did not participate in the drafting or submission of this petition. |
| · | In the Expanded Access Program (EAP), 50%
of patients (5/10) remain alive according to publicly available data. Estimated mean survival has reached approximately 84 months.
At the time of the Citizen Petition filing (July 2025), all five surviving patients were tracheostomy-free, as documented in the
petition. All 10 EAP patients exceeded 5-year survival versus ~20% historically. Notably, these patients entered into the Phase 3 trial
with higher baseline function (mean ALSFRS-R of approximately 41), reinforcing the strategic focus of the Phase 3b trial on earlier-stage
populations where the treatment effect may be most detectable. |
Corporate
| · | In February 2026, the company entered into
two strategic private placement agreements, each consisting of stock and warrants, securing a total of $2 million in funding. Together,
the company hopes these financings will reinforce a stable valuation for the company and provide the resources to support near-term operational
objectives and preparatory work for the planned Phase 3b ENDURANCE trial of NurOwn. |
Financial Results for the full year Ended December 31, 2025
| · | Cash, cash equivalents, and restricted cash were
approximately $0.3 million as of December 31, 2025. Subsequent to year-end, the company secured an additional $2 million in funding
through two private placements, as described above. |
| · | Research and development expenditures, net, for
the year ended December 31, 2025 were $4.2 million, compared to $4.7 million for the year ended December 31,
2024. |
| · | General and administrative expenses for the twelve
months ended December 31, 2025, and 2024 were approximately $5.8 million and $7.0 million, respectively. |
| · | Net loss for the twelve months ended December 31,
2025, was approximately $10.3 million, as compared to a net loss of approximately $11.6 million for the twelve months ended December 31,
2024. |
| · | Net loss per share for the twelve months ended December 31,
2025, and 2024 was $1.11 and $2.31, respectively. |
About NurOwn®
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. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative
diseases. The company’s proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic
factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection.
NurOwn® is BrainStorm’s lead investigational
therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is
set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights
into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal
time points, and a comprehensive analysis of the “Floor Effect” — a critical challenge in measuring clinical outcomes
in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed
a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from
the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic
proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational
patent covering its exosome technology, further strengthening BrainStorm’s growing IP portfolio in this emerging area of regenerative
medicine. To learn more, visit www.brainstorm-cell.com.
Notice Regarding Forward-Looking Statements
This
press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements
regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn
as a therapy for the treatment of ALS, the future availability of NurOwn to patients, the Phase 3b ENDURANCE study of NurOwn and the
future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate,"
"believe," "contemplate," "could," "estimate," "expect," "intend," "seek,"
"may," "might," "plan," "potential," "predict," "project," "target,"
"aim," "should," "will" "would," or the negative of these words or other similar expressions,
although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations
and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These 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, whether Brainstorm can successfully fund and complete the Phase 3b ENDURANCE
study of NurOwn and other factors detailed in BrainStorm's annual report on Form 10-K 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.
CONTACTS
Investors:
Michael Wood
Phone: +1 646-597-6983
mwood@lifesciadvisors.com
Media:
Uri Yablonka, Chief Business Officer
Phone: +1 917-284-2911
uri@brainstorm-cell.com
BRAINSTORM CELL THERAPEUTICS INC.
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share data)
| | |
December 31, | |
| | |
2025 | | |
2024 | |
| | |
U.S. $ in thousands | |
| ASSETS | |
| | | |
| | |
| | |
| | | |
| | |
| Current Assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 29 | | |
$ | 187 | |
| Other accounts receivable | |
| 86 | | |
| 63 | |
| Prepaid expenses and other current assets | |
| 192 | | |
| 135 | |
| Total current assets | |
$ | 307 | | |
$ | 385 | |
| | |
| | | |
| | |
| Long-Term Assets: | |
| | | |
| | |
| Other long-term assets | |
$ | 25 | | |
$ | 22 | |
| Restricted Cash | |
| 247 | | |
| 184 | |
| Operating lease right of use asset (Note 4) | |
| 208 | | |
| 807 | |
| Property and Equipment, Net (Note 5) | |
| 235 | | |
| 434 | |
| Total Long-Term Assets | |
$ | 715 | | |
$ | 1,447 | |
| | |
| | | |
| | |
| Total assets | |
$ | 1,022 | | |
$ | 1,832 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |
| | | |
| | |
| | |
| | | |
| | |
| Current Liabilities: | |
| | | |
| | |
| Accounts payables | |
$ | 7,067 | | |
$ | 6,080 | |
| Accrued expenses | |
| 396 | | |
| 619 | |
| Short-term loans (Note 11) | |
| 967 | | |
| 300 | |
| Operating lease liability (Note 4) | |
| 208 | | |
| 549 | |
| Employees related liability | |
| 2,369 | | |
| 1,430 | |
| Total current liabilities | |
$ | 11,007 | | |
$ | 8,978 | |
| | |
| | | |
| | |
| Long-Term Liabilities: | |
| | | |
| | |
| Operating lease liability (Note 4) | |
| — | | |
| 171 | |
| Warrants liability (Note 7) | |
| — | | |
| 447 | |
| Total long-term liabilities | |
$ | — | | |
$ | 618 | |
| | |
| | | |
| | |
| Total liabilities | |
$ | 11,007 | | |
$ | 9,596 | |
| | |
| | | |
| | |
| Stockholders’ Deficit: | |
| | | |
| | |
| Stock capital: (Note 8) | |
| 16 | | |
| 14 | |
| Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at December 31, 2025 and 100,000,000 shares at December 31, 2024 respectively; Issued and outstanding: 11,034,775 and 6,141,762 shares at December 31, 2025 and December 31, 2024 respectively | |
| | | |
| | |
| Additional paid-in-capital | |
| 227,058 | | |
| 218,974 | |
| Treasury stocks | |
| (116 | ) | |
| (116 | ) |
| Accumulated deficit | |
| (236,943 | ) | |
| (226,636 | ) |
| Total stockholders’ deficit | |
$ | (9,985 | ) | |
$ | (7,764 | ) |
| | |
| | | |
| | |
| Total liabilities and stockholders’ deficit | |
$ | 1,022 | | |
$ | 1,832 | |
The accompanying notes are an integral part of the consolidated financial
statements.
BRAINSTORM CELL THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS
U.S. dollars in thousands
(Except share data)
| | |
Year ended | |
| | |
December 31, | |
| | |
2025 | | |
2024 | |
| | |
U.S. $ in thousands | |
| Operating expenses: | |
| | | |
| | |
| | |
| | | |
| | |
| Research and development | |
$ | 4,175 | | |
$ | 4,651 | |
| General and administrative | |
| 5,778 | | |
| 7,042 | |
| | |
| | | |
| | |
| Operating loss | |
| (9,953 | ) | |
| (11,693 | ) |
| | |
| | | |
| | |
| Financial expense, net | |
| 533 | | |
| 77 | |
| | |
| | | |
| | |
| Gain on change in fair value of Warrants liability (Note 7) | |
| 179 | | |
| 147 | |
| | |
| | | |
| | |
| Net loss | |
$ | (10,307 | ) | |
$ | (11,623 | ) |
| | |
| | | |
| | |
| Basic and diluted net loss per share | |
$ | (1.11 | ) | |
$ | (2.31 | ) |
| | |
| | | |
| | |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | |
| 9,268,976 | | |
| 5,021,798 | |
The accompanying notes are an integral part of the
consolidated financial statements.
