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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): December 18, 2023
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 |
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 5.07 |
Submission of Matters to a Vote of Security Holders. |
On December 18, 2023, Brainstorm Cell Therapeutics
Inc. (the “Company”) held its Annual Meeting of Stockholders (the “Annual Meeting”), virtually via the internet
to consider and vote on the proposals set forth below, each of which is described in greater detail in the Company’s definitive
proxy statement filed with the U.S. Securities and Exchange Commission on November 8, 2023. The following actions were taken at the Annual
Meeting:
1. The six nominees (listed below) for election
to the Company’s Board of Directors (the “Board”) were elected to hold office until the next annual meeting of stockholders
and until their successors are duly elected and qualified or until their earlier resignation or removal, based upon the following votes:
| | |
Votes For | |
Votes
Withheld | |
Votes
Against | |
Abstentions | |
Broker
Non-Votes |
| Dr. Irit Arbel | |
5,564,322 | |
1,199,783 | |
N/A | |
N/A | |
19,712,778 |
| Dr. Anthony Polverino | |
5,683,534 | |
1,080,571 | |
N/A | |
N/A | |
19,712,778 |
| Dr. Jacob Frenkel | |
5,698,997 | |
1,065,108 | |
N/A | |
N/A | |
19,712,778 |
| Uri Yablonka | |
5,705,729 | |
1,058,376 | |
N/A | |
N/A | |
19,712,778 |
| Dr. Menghisteab Bairu | |
5,737,268 | |
1,026,837 | |
N/A | |
N/A | |
19,712,778 |
| Nir Naor | |
5,690,609 | |
1,073,496 | |
N/A | |
N/A | |
19,712,778 |
2. The proposal to ratify the appointment of Brightman Almagor Zohar & Co., a Firm in the Deloitte Global Network, as the Company’s
independent registered public accounting firm for the Company’s fiscal year ending December 31, 2024 was approved, based upon the
following votes:
| Votes For | |
Votes Withheld | |
Votes Against | |
Abstentions | |
Broker Non-Votes |
| 20,043,530 | |
N/A | |
448,253 | |
5,985,100 | |
N/A |
| Item 7.01 | Regulation FD Disclosure. |
On December 20, 2023, the Company issued a press release announcing
the issuance of a letter to shareholders from the Company’s President and Chief Executive Officer, Mr. Chaim Lebovits (the “Press
Release”). The Press Release is attached hereto as Exhibit 99.1 and is being furnished herewith.
The information in this Item 7.01 of this Current Report on Form 8-K
(the “Current Report”) and the Press Release being furnished herewith shall not be deemed “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections
11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the Press Release attached
as Exhibit 99.1 to this Current Report shall not be incorporated by reference into any filing with the Securities and Exchange Commission
made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
On December 17, 2023, the Board appointed Dr. Menghisteab Bairu to
the Audit Committee (the “Audit Committee”) of the Board to replace Dr. June S. Almenoff, effective from December 18, 2023.
The Board has determined that Dr. Menghisteab Bairu meets the requirements for independence of Audit Committee members under the applicable
listing standards of Nasdaq and the Securities Exchange Act of 1934, as amended. Effective as of December 18, 2023, the Audit Committee
is composed of Mr. Nir Naor (Chair), Dr. Irit Arbel and Dr. Menghisteab Bairu.
| 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. |
| |
|
|
| Date: December 20, 2023 |
By: |
/s/ Chaim Lebovits |
| |
|
Chaim Lebovits |
| |
Chief Executive Officer |
Exhibit 99.1
BrainStorm Issues 2023 Letter to
Shareholders
NEW YORK, Dec. 20, 2023 /PRNewswire/ -- BrainStorm
Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today issued
a Letter to shareholders.
Dear Shareholders,
We remain steadfast in our commitment to advancing NurOwn
as a promising treatment for ALS patients. Recognizing the challenges faced in our recent BLA submission, we are ambitiously pursuing
a Phase 3b trial, aligning with our dedication to the ALS community and our goal of making NurOwn commercially available. Despite the
setbacks with the ADCOM's unfavorable vote, our focus remains to align with the FDA on a phase 3b trial design, as we acknowledge that
this represents the most expedient pathway to approval.
We are exploring various strategies to secure the necessary
funding. We intend to seek a Special Protocol Assessment (SPA), which, when agreed with the FDA, could significantly de-risk the regulatory
aspects of the NurOwn program. We are very encouraged by the FDA's ongoing engagement, including the opportunity provided by the expedited
in-person Type A meeting on December 6, a rare occurrence in today's regulatory environment. We appreciate the Agency's feedback, comments
and other regulatory accommodations, signaling its recognition for the unmet need in ALS and its willingness to reach alignment with
Brainstorm on our new clinical strategy.
Our team is diligently preparing to submit a clinical protocol,
and Statistical Analysis Plan, for the FDA's review. Following alignment with the FDA's expectations, we will formally submit our SPA
request. We anticipate making this submission in February 2024. The FDA's response is expected within 45 days of submission.
We believe that agreement on an SPA would open a broad
spectrum of financing options for the trial. Concurrently, we are committed to maintaining our NASDAQ listing status. Our strategy focuses
on enhancing the value of our assets, thereby garnering market support that is crucial for our stock price to reach its requisite level
by April. We prefer this approach over a reverse stock split, as it aligns more closely with our long-term goals and shareholder interests.
We thank you for your continued support. Your faith in our
mission fuels our determination to overcome the recent challenges and ultimately deliver groundbreaking treatments that will help patients
in need and create value for our stakeholders.
Sincerely, Chaim Lebovits
President and CEO
BrainStorm Cell Therapeutics Inc
Special Protocol Assessment
A Special Protocol Assessment (SPA) is a process in
which drug developers may ask to meet with the FDA to reach agreement on the design and size of certain clinical trials to determine
if they adequately address scientific and regulatory requirements for a study that could support marketing approval. An SPA agreement
indicates concurrence by FDA with the adequacy and acceptability of specific critical elements of overall protocol design for a study
intended to support a future marketing application. These elements are critical to ensuring that the trial conducted under the protocol
can be considered an adequate and well-controlled study that can support marketing approval. Feedback on these issues provides the greatest
benefit to companies in planning late-phase development strategy. An SPA agreement does not indicate FDA concurrence on every protocol
detail.
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 statements regarding meetings with the U.S. Food and Drug Administration
(FDA), Special Protocol Assessment (SPA), ADCOM meeting related to NurOwn, the timing of a PDUFA action date for the BLA for NurOwn,
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.
Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg
CONTACTS
Investor Relations:
John Mullaly
LifeSci Advisors, LLC Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com
SOURCE BrainStorm Cell Therapeutics Inc.
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