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BrainStorm Cell Therapeutics (BCLI) widens Q2 2026 loss as it prepares Phase 3b ALS trial

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(Moderate)
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Form Type
8-K

Rhea-AI Filing Summary

BrainStorm Cell Therapeutics Inc. reported second quarter 2026 results and provided a corporate update centered on its NurOwn autologous stem cell platform for ALS and other neurodegenerative diseases. The company is completing preparations to initiate the Phase 3b ENDURANCE study of NurOwn in ALS under an FDA-agreed Special Protocol Assessment.

Peter Pitts, a former senior FDA official, has been appointed Executive Chairman with an active role in regulatory, operational, partnership and capital-markets initiatives. NurOwn has Orphan Drug designation in the U.S. and EU, with a completed Phase 3 ALS trial and a Phase 2 trial in progressive multiple sclerosis. BrainStorm is also advancing an allogeneic exosome-based platform and recently received a Notice of Allowance for a foundational exosome patent.

Financially, total assets were $788 thousand as of June 30, 2026, versus liabilities of $12,385 thousand, resulting in stockholders’ deficit of $(11,597) thousand. Cash and cash equivalents were $22 thousand$3,855 thousand (basic and diluted net loss per share of $0.35) compared with a net loss of $2,903 thousand a year earlier.

Positive

  • Phase 3b ENDURANCE ALS trial of NurOwn is being readied under an FDA-agreed Special Protocol Assessment, providing regulatory clarity around the upcoming study design.
  • Appointment of Peter Pitts as Executive Chairman, bringing former senior FDA experience to help lead regulatory, operational, partnership and capital-markets initiatives for the NurOwn program.
  • BrainStorm is expanding its pipeline with an allogeneic exosome-based platform and has received a Notice of Allowance for a foundational exosome patent, strengthening its IP position.

Negative

  • The company highlights risks related to its ability to raise additional capital and to continue as a going concern, underscoring significant financial dependence on future financing.
  • As of June 30, 2026, liabilities of $12,385 thousand substantially exceeded assets of $788 thousand, resulting in a stockholders’ deficit of $(11,597) thousand and indicating a highly leveraged balance sheet.
Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Total assets $788 thousand As of June 30, 2026; U.S. dollars in thousands
Total liabilities $12,385 thousand As of June 30, 2026; U.S. dollars in thousands
Stockholders’ deficit $(11,597) thousand As of June 30, 2026; U.S. dollars in thousands
Cash and cash equivalents $22 thousand As of June 30, 2026; U.S. dollars in thousands
Net loss, Q2 2026 $3,855 thousand Three months ended June 30, 2026; U.S. dollars in thousands
Net loss, six months 2026 $5,982 thousand Six months ended June 30, 2026; U.S. dollars in thousands
R&D expense, six months 2026 $1,725 thousand Six months ended June 30, 2026; U.S. dollars in thousands
G&A expense, six months 2026 $3,934 thousand Six months ended June 30, 2026; U.S. dollars in thousands
Special Protocol Assessment regulatory
"supported by an FDA-agreed protocol under a Special Protocol Assessment"
A special protocol assessment is a formal, written agreement between a drug or device developer and a health regulator about the design, size and analysis plans of a pivotal clinical trial or study. It matters to investors because it reduces regulatory uncertainty—like getting a signed blueprint before building—by signaling that if the study follows the agreed plan and meets its goals, the regulator is unlikely to reject the results solely for design reasons, though it does not guarantee approval.
Orphan Drug designation regulatory
"NurOwn ... has received Orphan Drug designation from both the U.S. Food and Drug Administration"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
autologous mesenchymal stem cells medical
"produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs)"
neurotrophic factors medical
"conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs)"
exosome-based platform technical
"advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins"
going concern financial
"including, without limitation, ... BrainStorm’s ability to continue as a going concern"
Going concern is the accounting assumption that a company will keep operating and meeting its obligations for the foreseeable future. The phrase matters most when a company or its auditors disclose substantial doubt about it, a formal warning that the business may not have enough resources to continue without raising money, restructuring, or selling assets. That language in a filing or press release signals elevated financial risk.
Net loss $3,855 thousand Compared with $2,903 thousand for the quarter ended June 30, 2025
Basic and diluted net loss per share $0.35 Compared with $0.34 for the quarter ended June 30, 2025
Operating loss $3,613 thousand Compared with $2,573 thousand for the quarter ended June 30, 2025

FAQ

What did BrainStorm Cell Therapeutics (BCLI) report for its Q2 2026 net loss?
BrainStorm reported a Q2 2026 net loss of $3,855 thousand, compared with $2,903 thousand in the same quarter of 2025. Basic and diluted net loss per share for Q2 2026 was $0.35.

What is the financial position of BrainStorm Cell Therapeutics (BCLI) as of June 30, 2026?
As of June 30, 2026, BrainStorm had total assets of $788 thousand and total liabilities of $12,385 thousand, resulting in a stockholders’ deficit of $(11,597) thousand, all in U.S. dollars in thousands.

How much cash did BrainStorm Cell Therapeutics (BCLI) have at the end of Q2 2026?
BrainStorm reported cash and cash equivalents of $22 thousand as of June 30, 2026. Restricted cash was an additional $187 thousand, reflecting limited immediate liquidity for ongoing operations.

What clinical progress did BrainStorm Cell Therapeutics (BCLI) highlight for NurOwn in ALS?
BrainStorm is finalizing preparations to initiate the Phase 3b ENDURANCE study of NurOwn in ALS, operating under an FDA Special Protocol Assessment. A previous Phase 3 ALS trial has already been completed.

What leadership change did BrainStorm Cell Therapeutics (BCLI) announce in this update?
The company announced the appointment of Peter Pitts as Executive Chairman. He will actively help lead regulatory, operational, partnership and capital-markets efforts, bringing experience as a former senior FDA official.

What are the main risks BrainStorm Cell Therapeutics (BCLI) cites going forward?
BrainStorm cites risks including its ability to raise additional capital, its ability to continue as a going concern, prospects for regulatory approval of NurOwn, and outcomes of future FDA interactions.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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

 

 

 

 

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    86 
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)   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   231,428    227,058 
Treasury stock   (116)   (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,   June 30, 
   2026   2025   2026   2025 
   Unaudited   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

 

 

 

Source: View Original Filing on SEC EDGAR

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