Form 8-K

8-K — BRAINSTORM CELL THERAPEUTICS INC.

Accession: 0001104659-26-097180

Filed: 2026-08-14

Period: 2026-08-14

CIK: 0001137883

SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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EX-99.1 — EXHIBIT 99.1 (tm2623188d1_ex99-1.htm)

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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):

August 14, 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 August 14, 2026, Brainstorm

Cell Therapeutics Inc. issued a press release announcing its financial results for the quarter ended June 30, 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 August 14, 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: August 14, 2026

By:

/s/ Chaim Lebovits

Chaim Lebovits

President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623188d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

BrainStorm Cell Therapeutics Announces Second

Quarter 2026 Financial Results and Provides Corporate Update

NEW YORK, Aug 14, 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 second quarter ended June 30, 2026, and provided a corporate update.

“We continue to advance and complete the

preparations necessary to initiate the Phase 3b ENDURANCE study of NurOwn in ALS, supported by an FDA-agreed protocol under a Special

Protocol Assessment,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm. “The recent appointment of

Peter Pitts as Executive Chairman represents an important enhancement to our leadership. Peter is joining the Company in an active executive

capacity and will help lead the regulatory, operational, partnership and capital-markets initiatives surrounding the NurOwn program. His

experience as a former senior FDA official brings an additional level of regulatory insight and strategic perspective as we prepare to

enter this next phase. ALS imposes an enormous burden on patients, families and caregivers, and we remain resolute in our commitment to

the ALS community and to advancing what we believe will be a valuable new therapeutic option.”

Recent Highlights

NurOwn® (MSC-NTF) for ALS

• Advancing readiness for the Phase 3b ENDURANCE trial of NurOwn.

BrainStorm is completing the operational and regulatory work needed to open ENDURANCE for enrollment. The trial is planned to enroll

about 200 patients with ALS in two 24-week parts: a randomized, double-blind, placebo-controlled portion (Part A), then an open-label

extension in which all participants receive NurOwn (Part B). The primary endpoint is change on the ALSFRS-R scale, and Part A results

are intended to support a new BLA. ENDURANCE will be conducted under a Special Protocol Assessment with the FDA, the first ever granted

for an ALS therapeutic candidate. For more information, refer to ClinicalTrials.gov NCT06973629.

Corporate and Leadership

• Appointed Peter J. Pitts as Executive Chairman. In July

2026, BrainStorm named Peter J. Pitts, a former FDA Associate Commissioner and co-founder of the Center for Medicine in the Public Interest,

as Executive Chairman and Chief Strategic Regulatory and Policy Officer. Mr. Pitts, who joined the Board in May 2026, will lead the Company’s

daily operations, partnerships, investor engagement, and regulatory strategy, focused primarily on advancing the Phase 3b ENDURANCE trial.

Professor Jacob Frenkel, in BrainStorm’s leadership since 2007 and Board Chairman since 2020, will transition to Senior Advisor.

• Completed private placements totaling $400,000, priced at

a premium to market. In May 2026, BrainStorm entered into private placement agreements for gross proceeds of $400,000. Together with

the $2.0 million raised in February 2026, capital raised in first-half 2026 totals approximately $2.4 million.

Publications

• Published a peer-reviewed

article calling for updated FDA approaches to ALS, rare diseases, and regenerative medicine.

In June 2026, BrainStorm announced an article co-authored by Peter J. Pitts and CEO Chaim

Lebovits in the Journal of the Academy of Public Health, “Restoring Regulatory Fairness

and Reclaiming Biomedical Leadership: ALS, Rare Disease Regulation, and the Future of Regenerative

Medicine.” The authors argue that regulation should keep pace with advances in

biomarkers, genomics, artificial intelligence, and precision medicine, and that tools such

as accelerated approval, adaptive trial design, and Bayesian statistics can improve therapy

development for ALS and other rare diseases. It highlights the Company’s Special Protocol

Assessment as a model of sponsor and regulator collaboration.

Financial Results for the Second Quarter Ended June 30, 2026

• Cash, cash equivalents, and restricted cash were approximately

$0.2 million as of June 30, 2026, compared to approximately $1.03 million as of June 30, 2025.

• Research and development expenditures, net, for the second quarter

of 2026 were approximately $1 million, compared to approximately $1.1 million for the second quarter of 2025.

• General and administrative expenses for the second quarter of

2026 were approximately $2.7 million, compared to approximately $1.5 million for the second quarter of 2025.

• Net loss for the second quarter of 2026 was approximately $3.9

million, compared to a net loss of approximately $2.9 million for the second quarter of 2025.

• Net loss per share for the second quarters of 2026 and 2025

was $(0.35) and $(0.34), respectively.

U.S. dollars in thousands

(Except share and per share amounts)

June 30,

December 31,

2026

2025

Unaudited

Audited

U.S. $ in thousands

ASSETS

Current Assets:

Cash and cash equivalents

$ 22

$ 29

Other accounts receivable

162

Prepaid expenses and other current assets

132

192

Total current assets

$ 316

$ 307

Long-Term Assets:

Prepaid expenses and other long-term assets

$ 27

$ 25

Restricted Cash

187

247

Right of use asset (Note 3)

106

208

Property and equipment, net

152

235

Total Long-Term Assets

$ 472

$ 715

Total assets

$ 788

$ 1,022

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

Current Liabilities:

Accounts payable

$ 7,488

$ 7,067

Accrued expenses

454

396

Short-term loans (Note 6)

1,261

967

Operating lease liability (Note 3)

113

208

Employees related liability

3,069

2,369

Total current liabilities

$ 12,385

$ 11,007

Total liabilities

$ 12,385

$ 11,007

Stockholders’ Deficit:

Stock capital: (Note 4)

Common stock $0.00005 par value; 250,000,000 shares authorized and 11,034,775 shares issued and outstanding

Additional paid-in-capital

231,428

227,058

Treasury stock

(116 )

Accumulated deficit

(242,925 )

(236,943 )

Total stockholders’ deficit

$ (11,597 )

$ (9,985 )

Total liabilities and stockholders’ deficit

$ 788

$ 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)

Six months ended

Three months ended

June 30,

2026

2025

2026

2025

Unaudited

Operating expenses:

Research and development, net

$ 1,725

$ 2,424

$ 963

$ 1,120

General and administrative

3,934

3,238

2,650

1,453

Operating loss

(5,659 )

(5,662 )

(3,613 )

(2,573 )

Financial income (expense), net

(323 )

(284 )

(242 )

(330 )

Gain (loss) on change in fair value of Warrants liability

179

Net loss

$ (5,982 )

$ (5,767 )

$ (3,855 )

$ (2,903 )

Basic and diluted net loss per share from continuing operations

$ (0.54 )

$ (0.77 )

$ (0.35 )

$ (0.34 )

Weighted average number of shares outstanding used in computing basic and diluted net loss per share

11,034,775

7,487,495

11,034,775

8,620,400

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), the 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. BrainStorm does 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 BrainStorm believes that the expectations reflected in the forward-looking

statements are reasonable, the Company 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

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