# EDGAR Filing Document

**Accession Number:** 0001137883
**File Stem:** 0001104659-25-059900
**Filing Date:** 2025-6
**Character Count:** 13916
**Document Hash:** 97d15e92d668dfb08e2ac87d3f8796d1
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-059900.hdr.sgml**: 20250616

**ACCESSION NUMBER**: 0001104659-25-059900

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20250616

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250616

**DATE AS OF CHANGE**: 20250616

**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:** 251050580

**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): June 16, 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:

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| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, $0.00005 par value BCLI | &nbsp;&nbsp; NASDAQ Stock Market LLC<br> (Nasdaq Capital Market) |

---

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 8.01 Other Items.**

On June 16, 2025, Brainstorm Cell Therapeutics Inc. (the "Company") issued a press release announcing new survival data from ten participants in its Expanded Access Program for NurOwn<sup>®</sup> (autologous MSC-NTF cells) in amyotrophic lateral sclerosis. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

**Item 9.01 Financial Statements and Exhibits.**

*(d) Exhibits.*

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2518123d1_ex99-1.htm) | [Press Release issued by the Company on June 16, 2025.](tm2518123d1_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: June 16, 2025 | By: | /s/ Chaim Lebovits |
|  |  | Chaim Lebovits |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**BrainStorm Announces New Survival Data from Expanded Access Program Cohort: Remarkably 90% of ALS Patients Survived Over 5 Years with NurOwn<sup>®</sup>**

**NEW YORK, NY, June 16, 2025** - BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn<sup>®</sup> (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial.

The analysis reviewed survival from the time of first symptom onset through participation in the Phase 3 trial, EAP Periods 1 and 2, followed by additional survival data collected through publicly available records.

EAP participants presented at the start of the Phase 3 trial relatively early in their disease course, with Mean ALSFRS-R at Baseline of 35.8 (Range: 32 – 40), followed by Mean ALSFRS-R at the start of the EAP of 31.4 (Range: 27 – 38; with one outlier score of 13).

**Key findings include:**

&nbsp;&nbsp;&nbsp;&nbsp;· 90% of participants (9/10) survived more than
five years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS survive
beyond five years. Notably, the single death in the cohort occurred following elective euthanasia.

&nbsp;&nbsp;&nbsp;&nbsp;· The median survival observed in the EAP cohort
was 6.8 years (range: 6 to 7 years) from symptom onset.

&nbsp;&nbsp;&nbsp;&nbsp;· Given
 that approximately 10% of individuals with ALS survive beyond five years <sup>1</sup> ,
 the probability of observing such extended survival in 9 out of 10 participants purely by
 chance is extremely low. This strongly suggests that the survival outcomes in this cohort
 are unlikely to be the result of random variation alone.

"These survival data provide encouraging real-world insights into the long-term experience of ALS patients treated with NurOwn under expanded access," said Chaim Lebovits, President and CEO of BrainStorm Cell Therapeutics. "We believe these findings add further evidence to support the upcoming Phase 3b clinical trial of NurOwn, to be conducted under an FDA Special Protocol Assessment (SPA). Our goal remains to generate high quality and conclusive data to demonstrate the benefit of NurOwn in people living with ALS."

Bob Dagher, MD, Chief Medical Officer of BrainStorm Cell Therapeutics, stated: "The fact that 9 out of 10 EAP participants surpassed five years of survival from first symptom - in contrast with the very modest expected survival pattern typically seen in ALS - represents a clinically meaningful observation. Furthermore, 6 out of 10 patients are still alive, even post seven years from symptom onset. These data further strengthen the scientific rationale to pursue our pivotal Phase 3b trial of NurOwn in ALS, under full alignment with the FDA guidance."

&nbsp;&nbsp;&nbsp;&nbsp;1. National
Institute of Neurological Disorders and Stroke (NINDS), NIH. *Amyotrophic Lateral Sclerosis (ALS) Fact Sheet*. https://www.ninds.nih.gov/health-information/disorders/amyotrophic-lateral-sclerosis-als &hookleftar↩

The NurOwn EAP was designed to provide compassionate access to NurOwn for eligible ALS participants who completed the Phase 3 trial. The observed durability of survival in this cohort, as reflected in the publicly sourced survival data, underscores the importance of advancing the upcoming registrational Phase 3b controlled clinical trial.

**About NurOwn®** <br> 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**. <br> BrainStorm Cell Therapeutics Inc. (NASDAQ: 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** <br> 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:<br> Michael Wood <br> Phone: +1 646-597-6983 <br> mwood@lifesciadvisors.com

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