false
0001137883
0001137883
2026-05-15
2026-05-15
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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):
May 15, 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 May 15, 2026,
Brainstorm Cell Therapeutics Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026. 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 May 15, 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: May 15, 2026 |
By: |
/s/ Chaim Lebovits |
| |
|
Chaim Lebovits |
| |
|
President and Chief Executive Officer |
Exhibit 99.1
BrainStorm Cell Therapeutics Announces First
Quarter 2026 Financial Results and Provides Corporate Update
NEW YORK, May 15,
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 three months ended March 31, 2026, and provided a corporate
update.
“The team at BrainStorm is focused on completing
the final steps required to initiate our planned Phase 3 ENDURANCE study of NurOwn in ALS,” said Chaim Lebovits, President and CEO.
“Site activation, manufacturing readiness, and regulatory engagement are all progressing, and, subject to securing the necessary
financing, we are well positioned to move into the enrollment phase. ENDURANCE is designed to enroll patients with earlier-stage disease,
where NurOwn's mechanism has the greatest opportunity to demonstrate benefit. ALS is a devastating illness with limited therapeutic options,
and we remain committed to the community to complete NurOwn's development and make it available to those who need it."
Recent Highlights
NurOwn® (MSC-NTF) for ALS
| · | BrainStorm continues its preparations for the Phase 3b ENDURANCE study of NurOwn, with clinical sites
on standby and manufacturing and operational activities well underway. The planned study is expected to enroll approximately 200 participants
across leading ALS centers and is designed as a two-part trial: a 24-week randomized, double-blind, placebo-controlled segment (Part A)
followed by a 24-week open-label extension (Part B) to further characterize long-term safety and durability of effect. The primary
efficacy endpoint will measure change from baseline to Week 24 on the ALSFRS-R scale. |
| · | ENDURANCE
Part A completion expected to support new BLA submission. Successful completion
of Part A of the study is anticipated to generate the clinical data required to support
a new Biologics License Application (BLA) submission for NurOwn. Further trial details are
posted on ClinicalTrials.gov ID NCT06973629. |
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, these financings are expected to 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 Three Months Ended March 31, 2026
| · | Cash, cash equivalents, and restricted cash were approximately $0.2 million as of March 31, 2026,
compared to approximately $0.3 million as of December 31, 2025. |
| · | Research and development expenditures, net, for the three months ended March 31, 2026 were approximately
$0.8 million, compared to approximately $1.3 million for the three months ended March 31, 2025. |
| · | General and administrative expenses for the three months ended March 31, 2026 were approximately
$1.3 million, compared to approximately $1.8 million for the three months ended March 31, 2025. |
| · | Net loss for the three months ended March 31, 2026 was approximately $2.1 million, as compared to
a net loss of approximately $2.9 million for the three months ended March 31, 2025. |
| · | Net loss per share for the three months ended March 31, 2026 and 2025 was $(0.19) and $(0.45), respectively. |
BRAINSTORM CELL THERAPEUTICS INC. AND
SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
(Except share and per share amounts)
| | |
March 31, | | |
December 31, | |
| | |
2026 | | |
2025 | |
| | |
Unaudited | | |
Audited | |
| | |
U.S. $ in thousands | |
| ASSETS | |
| | | |
| | |
| | |
| | | |
| | |
| Current Assets: | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 15 | | |
$ | 29 | |
| Other accounts receivable | |
| 122 | | |
| 86 | |
| Prepaid expenses and other current assets | |
| 47 | | |
| 192 | |
| Total current assets | |
$ | 184 | | |
$ | 307 | |
| | |
| | | |
| | |
| Long-Term Assets: | |
| | | |
| | |
| Prepaid expenses and other long-term assets | |
$ | 25 | | |
$ | 25 | |
| Restricted Cash | |
| 191 | | |
| 247 | |
| Right of use asset (Note 3) | |
| 157 | | |
| 208 | |
| Property and equipment, net | |
| 198 | | |
| 235 | |
| Total Long-Term Assets | |
$ | 571 | | |
$ | 715 | |
| | |
| | | |
| | |
| Total assets | |
$ | 755 | | |
$ | 1,022 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | |
| | | |
| | |
| | |
| | | |
| | |
| Current Liabilities: | |
| | | |
| | |
| Accounts payable | |
$ | 7,317 | | |
$ | 7,067 | |
| Accrued expenses | |
| 414 | | |
| 396 | |
| Short-term loans (Note 6) | |
| 1,329 | | |
| 967 | |
| Operating lease liability (Note 3) | |
| 159 | | |
| 208 | |
| Employees related liability | |
| 2,545 | | |
| 2,369 | |
| Total current liabilities | |
$ | 11,764 | | |
$ | 11,007 | |
| | |
| | | |
| | |
| Total liabilities | |
$ | 11,764 | | |
$ | 11,007 | |
| | |
| | | |
| | |
| Stockholders’ Deficit: | |
| | | |
| | |
| Stock capital: (Note 4) | |
| 16 | | |
| 16 | |
| Common stock $0.00005 par value; 250,000,000 shares authorized and 11,034,775 shares issued and outstanding | |
| | | |
| | |
| Additional paid-in-capital | |
| 228,161 | | |
| 227,058 | |
| Treasury stock | |
| (116 | ) | |
| (116 | ) |
| Accumulated deficit | |
| (239,070 | ) | |
| (236,943 | ) |
| Total stockholders’ deficit | |
$ | (11,009 | ) | |
$ | (9,985 | ) |
| | |
| | | |
| | |
| Total liabilities and stockholders’ deficit | |
$ | 755 | | |
$ | 1,022 | |
The accompanying notes are an integral part of the consolidated financial statements.
BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands
(Except share
and per share amounts)
| | |
Three months ended | |
| | |
March 31, | |
| | |
2026 | | |
2025 | |
| | |
Unaudited | |
| Operating expenses: | |
| | | |
| | |
| | |
| | | |
| | |
| Research and development, net | |
$ | 762 | | |
$ | 1,304 | |
| General and administrative | |
| 1,284 | | |
| 1,785 | |
| | |
| | | |
| | |
| Operating loss | |
| (2,046 | ) | |
| (3,089 | ) |
| | |
| | | |
| | |
| Financial income (expense), net | |
| (81 | ) | |
| 46 | |
| | |
| | | |
| | |
| Change in fair value of warrant liability | |
| — | | |
| 179 | |
| | |
| | | |
| | |
| Net loss | |
$ | (2,127 | ) | |
$ | (2,864 | ) |
| | |
| | | |
| | |
| Basic and diluted net loss per share | |
$ | (0.19 | ) | |
$ | (0.45 | ) |
| | |
| | | |
| | |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | |
| 11,034,775 | | |
| 6,342,002 | |
The accompanying notes are an integral part of the consolidated financial statements.
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, 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, 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.
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
