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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): November 20, 2023
Brainstorm Cell Therapeutics Inc.
(Exact name of registrant as specified in its
charter)
Delaware |
|
001-36641 |
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20-7273918 |
(State or other jurisdiction of
incorporation) |
|
(Commission File No.) |
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(IRS Employer Identification No.) |
1325 Avenue of Americas, 28th Floor |
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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) |
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¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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¨ |
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 |
NASDAQ Stock Market LLC
(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 Events.
On November 20, 2023, Brainstorm Cell Therapeutics
Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (the “FDA”)
had granted the Company a meeting to discuss the regulatory path forward for NurOwn® in amyotrophic lateral sclerosis (“ALS”).
The Company’s meeting with the FDA is scheduled to take place on December 6, 2023. 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.
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. |
|
|
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Date: November 22, 2023 |
By: |
/s/ Chaim Lebovits |
|
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Chaim Lebovits |
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President and Co-Chief Executive Officer |
Exhibit 99.1
BrainStorm Cell Therapeutics Announces In-Person
Meeting with the FDA to Discuss Confirmatory Phase 3 Trial for NurOwn® in ALS
Meeting will take place on December 6; Company plans to seek Special
Protocol Assessment (SPA)
NEW YORK, Nov. 20, 2023 /PRNewswire/ --BrainStorm Cell Therapeutics
Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that the
US Food & Drug Administration (US FDA) has granted the company a meeting to discuss the regulatory path forward for NurOwn® in
amyotrophic lateral sclerosis (ALS). The meeting is scheduled to take place on December 6, 2023. Brainstorm will discuss plans for
a Special Protocol Assessment (SPA) with the FDA to agree on the overall protocol design for a confirmatory Phase 3 trial in ALS.
“We are pleased that the FDA has granted this expedited in-person
meeting to discuss the best path forward for NurOwn for ALS,” said Chaim Lebovits, President and Chief Executive Officer of BrainStorm.
“Our proposed plan is to conduct a confirmatory Phase 3b trial and it is important that we are aligned with the Agency on the expected
requirements for re-submitting a Biologics License Application. We believe that reaching an agreement through a SPA on the overall protocol
design and the adequacy to address the requirements for marketing approval will be a key step to position the company for success and
to potentially de-risk the program. We are grateful for the FDA’s support and quick response in granting this meeting as we
remain committed to our goal of making NurOwn available to the ALS community.”
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 harvested from each person with ALS and are manufactured using an innovative and proprietary process to secrete neurotrophic factors
to target specific neurodegenerative diseases. The lead program for NurOwn is for the treatment of ALS. BrainStorm’s long-term commitment
to ALS is demonstrated in preclinical research and a series of clinical studies, all of which have been published in peer-reviewed journals.
The NurOwn clinical program has generated valuable insights into the
pathology of ALS, as well as disease progression and treatment. Since the initial Phase 3 readout, BrainStorm has shared the full dataset
through rigorous peer-reviewed analysis, including: quantification of Floor Effect, which had been noted, but never before explored in
depth; evaluation of multiple pre-specified biomarkers, collected at seven different points across 20 weeks during the trial, allowing
a longitudinal view; and analysis of genetic data, which represents one of the first ALS trials to prospectively invoke pharmacogenomic
analysis of clinical outcome, offering great promise for the development of future treatments for ALS.
About BrainStorm Cell Therapeutics Inc.
BrainStorm Cell Therapeutics Inc. is a leading developer of innovative
autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. BrainStorm holds the rights to clinical development
and commercialization of the NurOwn® technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide
licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration
(FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase
3 trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and
was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989), and another grant from the ALS Association
and I AM ALS. BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718)
of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).
Notice Regarding Forward-Looking Statements
This press release contains “forward-looking statements”
that are subject to substantial risks and uncertainties, including 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
John Mullaly
LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com
Logo - https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
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