# EDGAR Filing Document

**Accession Number:** 0001137883
**File Stem:** 0001104659-25-078116
**Filing Date:** 2025-8
**Character Count:** 20405
**Document Hash:** 6c9797e4b71204d0eda8ea8004cef9df
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-078116.hdr.sgml**: 20250814

**ACCESSION NUMBER**: 0001104659-25-078116

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250814

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250814

**DATE AS OF CHANGE**: 20250814

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** BRAINSTORM CELL THERAPEUTICS INC.
- **CENTRAL INDEX KEY:** 0001137883
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 207273918
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36641
- **FILM NUMBER:** 251214394

**BUSINESS ADDRESS:**
- **STREET 1:** 1325 AVENUE OF AMERICAS
- **STREET 2:** 28TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10019
- **BUSINESS PHONE:** 201-488-0460

**MAIL ADDRESS:**
- **STREET 1:** 1325 AVENUE OF AMERICAS
- **STREET 2:** 28TH FLOOR
- **CITY:** NEW YORK
- **STATE:** NY
- **ZIP:** 10019

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** BRAINSTORM CELL THERAPEUTICS INC
- **DATE OF NAME CHANGE:** 20041122

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** GOLDEN HAND RESOURCES INC
- **DATE OF NAME CHANGE:** 20030827

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** WIZBANG TECHNOLOGIES INC
- **DATE OF NAME CHANGE:** 20010409

?xml version='1.0' encoding='ASCII'?

**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, 2025

**Brainstorm Cell Therapeutics Inc.** 

(Exact name of registrant as specified in its charter)

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| | | | | |
|:---|:---|:---|:---|:---|
| **Delaware** |  | **001-36641** |  | **20-7273918** |
| *(State or other jurisdiction of <br> 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 | Name of each exchange on which registered |
| Common Stock, $0.00005 par value BCLI | &nbsp;&nbsp; OTCQB Venture Market<br> (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, 2025, Brainstorm Cell Therapeutics Inc. issued a press release announcing its financial results for the quarter ended June 30, 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.* 

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2523508d1_ex99-1.htm) | [Press Release issued by Brainstorm Cell Therapeutics Inc. on August 14, 2025.](tm2523508d1_ex99-1.htm) |
| 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.** | **BRAINSTORM CELL THERAPEUTICS INC.** |
| Date: August 14, 2025 | By: | /s/ Chaim Lebovits |
|  |  | Chaim Lebovits |
|  |  | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update**

*Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025*

NEW YORK, Aug. 14, 2025 /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, 2025, and provided a corporate update.

![](tm2523508d1_ex99-1img01.jpg)

"BrainStorm remains focused on executing our clinical development plan for NurOwn<sup>®</sup>. We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, President and CEO. "We are also advancing key operational activities, including discussions with clinical sites as well as ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply. We are encouraged by the ongoing interest and support from clinicians and the ALS community, and we remain confident that, if approved, NurOwn has the potential to make a meaningful difference for patients and their families."

Mr. Lebovits continued, "We support the FDA's consideration of the Citizen Petition, which may provide a fresh opportunity for an objective evaluation of the scientific evidence. We continue to stand behind the integrity and rigor of our data and will continue to engage with clinicians and the ALS community."

**Recent Highlights**

<u>NurOwn (MSC-NTF) for ALS</u>

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· **FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn<sup>®</sup>** The
 Phase 3b trial, known as ENDURANCE, is expected to enroll approximately 200 participants
 at leading academic medical centers and will consist of a 24-week randomized, double-blind,
 placebo-controlled phase, followed by a 24-week open-label extension in which all participants
 will receive NurOwn. The primary endpoint is the change from baseline to week 24 in the ALS
 Functional Rating Scale-Revised (ALSFRS-R). Successful completion of the double blind
 portion of the study (Part A) is expected to generate the clinical data needed to support
 a new BLA submission. Details of the trial, including a list of anticipated participating
 clinical sites, are available on ClinicalTrials.gov ID <u>NCT06973629</u>.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· **A Citizens Petition submitted to the FDA by ALS Community requesting a new review of the NurOwn data** The company acknowledges
that the FDA's consideration of the petition provides a new opportunity to reaffirm NurOwn's potential as a therapy for ALS. BrainStorm
was not involved in drafting or submitting this petition or its contents.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· **New survival data from NurOwn Expanded Access Program** show that 100% of participants (10/10) in the EAP survived more than
5 years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS would
survive beyond 5 years. The single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP
cohort was 6.8 years (range: 6 to 7 years) from symptom onset. Although the EAP cohort included participants earlier in their disease
course, these results are encouraging and support further study.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· **Manufacturing Partnership with Minaris** BrainStorm has signed a Letter of Intent (LOI) <u>with Minaris Advanced Therapies</u>, a global contract development and manufacturing organization
 (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for the upcoming Phase
 3b clinical trial.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· **NurOwn® data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting** The new pharmacogenomic data were delivered in an
oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, in New Orleans. The
data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured
in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the
ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how
they will shape the future of cell therapies."

**Financial Results for the Second quarter Ended June 30, 2025**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Cash,
cash equivalents, and restricted cash were approximately $1.03 million as of June 30, 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Research
and development expenditures, net, for the quarter ended June 30, 2025 were $1.1 million, compared to $0.9 million for the quarter ended
June 30, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· General
and administrative expenses for the quarter ended June 30, 2025 were approximately $1.4 million, compared to approximately $2.1 million
for the quarter ended June 30, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Net
loss for the quarter ended June 30, 2025, was approximately $2.9 million, as compared to a net loss of approximately $2.5.4 million for
the quarter ended June 30, 2024.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Net
loss per share for the three months ended June 30, 2025, and 2024 was $0.34 and $0.60, respectively.

**Conference Call and Webcast**

<u>Participant Numbers:</u>

---

| | |
|:---|:---|
| Toll Free | 877-545-0320 |
| International | 973-528-0002 |
| Participant Access Code | 601260 |
| Webcast | <u>https://shorturl.at/xrBQQ</u> |

---

The replay of the conference call can be accessed by dialing the numbers below and will be available until August 28.

<u>Replay Numbers:</u>

Toll Free <u>877-481-4010 </u> <br> <u>International</u> <u>919-882-2331</u> <br> <u>Reply Passcode</u> <u>52831</u>

**<u>About NurOwn®</u>**

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.

**<u>About BrainStorm Cell Therapeutics Inc.</u>**

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 <u>www.brainstorm-cell.com</u>.

**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.

**<u>CONTACTS</u>**

Investors:<br> Michael Wood<br> Phone: +1 646-597-6983<br> <u>mwood@lifesciadvisors.com</u>

Media:

Uri Yablonka, Chief Business Officer<br> Phone: +1 917-284-2911<br> <u>uri@brainstorm-cell.com</u>

**<u>BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES</u>**

**<u>INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS</u>**

**U.S. dollars in thousands**

**(Except share data)**

---

| | | |
|:---|:---|:---|
|  | **June 30,** | **December 31,** |
|  | **2025** | **2024** |
|  | **Unaudited** | **Audited** |
|  | **U.S. $ in thousands** | **U.S. $ in thousands** |
| **<u>ASSETS</u>** |  |  |
| **Current Assets:** |  |  |
| Cash and cash equivalents | $824 | $187 |
| Other accounts receivable | 106 | 63 |
| Prepaid expenses and other current assets | 585 | 135 |
| **Total current assets** | $1515 | $385 |
| **Long-Term Assets:** |  |  |
| Prepaid expenses and other long-term assets | $24 | $22 |
| Restricted Cash | 201 | 184 |
| Operating lease right of use asset (Note 3) | 495 | 807 |
| Property and Equipment, Net | 331 | 434 |
| **Total Long-Term Assets** | $1051 | $1447 |
| **Total assets** | $2566 | $1832 |
| **<u>LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)</u>** |  |  |
| **Current Liabilities:** |  |  |
| Accounts payables | $5997 | $6080 |
| Accrued expenses | 367 | 619 |
| Short-term loans (Note 7) | 101 | 300 |
| Operating lease liability (Note 3) | 381 | 549 |
| Employees related liability | 1682 | 1430 |
| **Total current liabilities** | $8528 | $8978 |
| **Long-Term Liabilities:** |  |  |
| Operating lease liability (Note 3) | 95 | 171 |
| Warrants liability (Note 4) | - | 447 |
| **Total long-term liabilities** | $95 | $618 |
| **Total liabilities** | $8623 | $9596 |
| **Stockholders' Deficit:** |  |  |
| Stock capital: (Note 5) | 16 | 14 |
| Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at June 30, 2025 and at December 31, 2024 respectively; Issued and outstanding: 10,120,109 and 6,141,762 shares at June 30, 2025 and December 31, 2024 respectively |  |  |
| Additional paid-in-capital | 226446 | 218974 |
| Treasury stocks | (116) | (116) |
| Accumulated deficit | (232403) | (226636) |
| **Total stockholders' deficit** | $(6057) | $(7764) |
| **Total liabilities and stockholders' deficit** | $2566 | $1832 |

---

**<u>BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES</u>**

**<u>INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)</u>**

**U.S. dollars in thousands**

**(Except share data)**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | **Six months ended** | **Six months ended** | **Three months ended** | **Three months ended** |
|  | **June 30,** | **June 30,** | **June 30,** | **June 30,** |
|  | **2025** | **2024** | **2025** | **2024** |
|  | **Unaudited** | **Unaudited** | **Unaudited** | **Unaudited** |
| **Operating expenses:** |  |  |  |  |
| Research and development, net | $2424 | $1883 | $1120 | $922 |
| General and administrative | 3238 | 3573 | 1453 | 2060 |
| **Operating loss** | (5662) | (5456) | (2573) | (2982) |
| Financial income (expense), net | (284) | 43 | (330) | 30 |
| Gain (loss) on change in fair value of Warrants liability (Note 4) | 179 | 529 | - | (411) |
| **Net loss** | $(5767) | $(5942) | $(2903) | $(2541) |
| Basic and diluted net loss per share from continuing operations | $(0.77) | $(1.35) | $(0.34) | $(0.60) |
| Weighted average number of shares outstanding used in computing basic and diluted net loss per share | 7487495 | 4531801 | 8620400 | 4747699 |

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Logo - <u>https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg</u>