0001137883
false
0001137883
2023-10-18
2023-10-18
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): October 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 2.05 Costs Associated with Exit or Disposal Activities.
On October 18, 2023, Brainstorm Cell Therapeutics
Inc. (the “Company”) committed to a reduction in force that is expected to result in a reduction in its headcount of approximately
30% (the “RIF”). The Company is taking this step to decrease its costs and strategically realign itself to enable accelerated
development of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS).
In connection with the RIF, the Company currently
estimates it will incur a range of costs and expenses of approximately $450,000-$900,000, consisting primarily of cash severance costs
and one-time termination benefits. The Company expects to substantially complete the RIF by the end of 2023. The estimates of costs and
expenses that the Company expects to incur in connection with the RIF are subject to a number of assumptions and actual results may differ
materially. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that
are associated with, the RIF.
Item 5.02 Departure of Directors or Certain
Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
In connection with the
RIF and the Company’s strategic realignment, Dr. Kirk Taylor, EVP and Chief Medical Officer, stepped down from his post, effective
as of October 18, 2023. Dr. Taylor’s separation from the Company is not due to any disagreement with the Company
on any matter, or relating to its operations, policies, or practices.
Item 7.01 Regulation FD Disclosure.
On October 24, 2023, the Company issued a press release, a copy of
which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.
The information set forth in this Item 7.01 of this Current Report
on Form 8-K and the accompanying Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange
Act of 1934, as amended (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, regardless of any general incorporation
language in such filing, unless expressly incorporated by reference in such filing.
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: October 24, 2023 |
By: |
/s/ Chaim Lebovits |
| |
|
Chaim Lebovits |
| |
|
Co-Chief Executive Officer |
Exhibit 99.1
BrainStorm Cell Therapeutics Announces Strategic
Realignment
Prioritizing NurOwn® for the
Treatment of ALS
- Resource consumption will be reduced by 50% to accelerate ALS development
- Plans underway for registrational Phase 3b U.S. clinical trial for NurOwn in ALS
NEW YORK, October 24, 2023 /PRNewswire/ -- BrainStorm
Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today
announced a strategic realignment to enable accelerated development of NurOwn® for the treatment of amyotrophic
lateral sclerosis (ALS). This realignment is designed to 1) support the company plans to conduct a double-blind, placebo-controlled Phase
3b U.S. clinical trial for NurOwn in ALS with an open-label extension and 2) continue to publish data from NurOwn’s Phase 3 clinical
trial on: biomarkers, long-term safety and survival, and the Expanded Access Program, providing transparency around NurOwn
data and progressing ALS drug development. In preparation for the trial design and subsequent meeting with FDA, BrainStorm is consulting
with the NurOwn Principal Investigators, who are most familiar with NurOwn, an additional panel of independent ALS experts, and a patient
advisory group.
“While the Phase 3 trial was confounded by the ALSFRS-R scale’s
inability to measure disease progression in participants with advanced ALS, the trial did demonstrate a clinically meaningful response
in a pre-specified subgroup of patients with less advanced disease. This finding was further supported by biomarker data,” said
Stacy Lindborg PhD, co-Chief Executive Officer of BrainStorm. “Based on learnings from the Phase 3 trial, we believe in the utility
of NurOwn in mild to moderate ALS and that the ALS community deserves every effort we can give to definitively demonstrate its clinical
value.”
To fund the Phase 3b study and ALS priorities, BrainStorm is actively
exploring various options to raise capital including non-dilutive grants and capitalizing on its exosome technology. At the same time,
the company will reduce and refocus resources by streamlining clean room operations and undertaking a targeted reduction in headcount
of approximately 30 percent. Positions most critical to the implementation of the Phase 3b trial and regulatory submission and review
will be retained. The strategic realignment will cut total resource consumption by approximately half.
As part of this strategic realignment, Dr. Kirk Taylor, EVP and Chief
Medical Officer, stepped down from his post, which largely focused on leading global medical affairs and broader launch activities. Certain
other positions that are outside the current prioritized scope will be eliminated.
“We are extremely grateful for the dedication and contributions
of our impacted colleagues, particularly Dr. Taylor who added tremendous value during his time with BrainStorm,” said Chaim Lebovits,
President and Chief Executive Officer of BrainStorm. “We remain steadfast in our goal to make NurOwn available to the ALS community
as quickly as possible, and we believe that this strategic realignment offers our best chance for success. While remaining open to partnership
opportunities that could accelerate growth, the steps we are taking now reflect our unwavering commitment to those battling this horrific
disease and our firm belief in the potential value of NurOwn.”
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:
Investor Relations:
John Mullaly
LifeSci Advisors, LLC
Phone: +1 617-429-3548
jmullaly@lifesciadvisors.com
Media:
Lisa Guiterman
Phone: +1 202-330-3431
lisa.guiterman@gmail.com
v3.23.3
| X |
- DefinitionBoolean flag that is true when the XBRL content amends previously-filed or accepted submission.
| Name: |
dei_AmendmentFlag |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionFor the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
| Name: |
dei_DocumentPeriodEndDate |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:dateItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
| Name: |
dei_DocumentType |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:submissionTypeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 1 such as Attn, Building Name, Street Name
| Name: |
dei_EntityAddressAddressLine1 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionAddress Line 2 such as Street or Suite number
| Name: |
dei_EntityAddressAddressLine2 |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- Definition
+ References
+ Details
| Name: |
dei_EntityAddressCityOrTown |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCode for the postal or zip code
| Name: |
dei_EntityAddressPostalZipCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the state or province.
| Name: |
dei_EntityAddressStateOrProvince |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:stateOrProvinceItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionA unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityCentralIndexKey |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:centralIndexKeyItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionIndicate if registrant meets the emerging growth company criteria. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityEmergingGrowthCompany |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionCommission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
| Name: |
dei_EntityFileNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:fileNumberItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTwo-character EDGAR code representing the state or country of incorporation.
| Name: |
dei_EntityIncorporationStateCountryCode |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarStateCountryItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityRegistrantName |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionThe Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
| Name: |
dei_EntityTaxIdentificationNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:employerIdItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionLocal phone number for entity.
| Name: |
dei_LocalPhoneNumber |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:normalizedStringItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
| Name: |
dei_PreCommencementIssuerTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
| Name: |
dei_PreCommencementTenderOffer |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTitle of a 12(b) registered security. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
| Name: |
dei_Security12bTitle |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:securityTitleItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionName of the Exchange on which a security is registered. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
| Name: |
dei_SecurityExchangeName |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:edgarExchangeCodeItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Section 14a
-Number 240
-Subsection 12
| Name: |
dei_SolicitingMaterial |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionTrading symbol of an instrument as listed on an exchange.
| Name: |
dei_TradingSymbol |
| Namespace Prefix: |
dei_ |
| Data Type: |
dei:tradingSymbolItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
| X |
- DefinitionBoolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act. Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
| Name: |
dei_WrittenCommunications |
| Namespace Prefix: |
dei_ |
| Data Type: |
xbrli:booleanItemType |
| Balance Type: |
na |
| Period Type: |
duration |
|
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Brainstorm Cell Therapeu... (NASDAQ:BCLI)
Historical Stock Chart
From Apr 2023 to Apr 2024
