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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): April 16, 2024
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 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Resignation of Stacy Lindborg as Co-Chief Executive Officer
On April 16, 2024, Dr. Stacy Lindborg, the Co-Chief Executive Officer of Brainstorm Cell Therapeutics Inc. (the “Company”), provided the Company with notice of her intent to resign from her current role at the Company, effective as of May 9, 2024. Dr. Lindborg’s resignation is not a result of any disagreement with the Company or its Board of Directors (the “Board”), or any matter relating to its operations, policies or practices.
Stacy Lindborg Separation Agreement
On April 16, 2024, the Company and Dr. Lindborg entered into a Separation Agreement (the “Separation Agreement”), with effect from May 9, 2024 (the “Separation Date”). Under the Separation Agreement, among others, (i) the Company agrees to pay Dr. Lindborg a lump sum of $300,000 as separation bonus, which shall be paid in full by March 15, 2025, (ii) Dr. Lindborg agrees to a general release of all claims that she may have against the Company, and (iii) Dr. Lindborg agrees to serve as a member of the Board effective as of the Separation Date. In addition, Dr. Lindborg’s outstanding equity awards, other than her March 11, 2024 grant of 241,935 shares of restricted stock (the “March 2024 RSA”), will cease vesting following the Separation Date and any such awards that are unvested as of the Separation Date will be forfeited. Dr. Lindborg’s March 2024 RSA will continue vesting while Dr. Lindborg is a member of the Board in accordance with the relevant equity agreement between her and the Company and the applicable equity plan of the Company, provided, however, that any unvested shares shall accelerate and become fully vested in the event of a change of control of the Company. Dr. Lindborg is subject to certain ongoing obligations as set forth in the Separation Agreement, her offer letter dated as of May 26, 2020, as amended, and the Company’s standard assignment, non-competition, non-solicitation and confidentiality agreement, which include, among others, post-separation non-competition obligations.
Appointment of Stacy Lindborg to the Board
Dr. Lindborg has been appointed to serve as a member of the Board, with effect from the Separation Date.
Dr. Lindborg served as the Company’s Co-Chief Executive Officer from January 2023 to April 2024. Prior to this, from June 2020 to January 2023, Dr. Lindborg served as our Executive Vice President and Chief Development Officer. She currently serves on the board of directors of Imunon, Inc. (formerly Celsion Corporation), a publicly-traded clinical stage biotechnology company. Dr. Lindborg previously served at Biogen Inc. (“Biogen”) from 2012 to 2020, where she was most recently Vice President, Analytics and Data Science. She also served on the R&D governance team during a time of significant growth for Biogen, and was active in guiding the firm’s long-term vision for growth through analytics and by stimulating innovative development platforms to increase productivity. Prior to her role at Biogen, Dr. Lindborg worked at Eli Lilly & Company, where she held positions of increasing responsibility. In her role as the Head of R&D strategy, she was responsible for characterizing the productivity of the portfolio and driving key R&D strategy projects including the annual R&D Long-Range Plan. Additionally, she was Leader of Zyprexa Product Management in which she was responsible for R&D, Commercial and Manufacturing plans. Dr. Lindborg holds a Ph.D. in statistics from Baylor University.
Other than the Separation Agreement, there are no arrangements or understandings between Dr. Lindborg and any other persons pursuant to which she was appointed to the Board. There are also no family relationships between Dr. Lindborg and the executive officers or directors of the Company, and no transactions involving the Company and Dr. Lindborg that the Company would be required to report pursuant to Item 404(a) of Regulation S-K.
After Dr. Lindborg joins the Board on the Separation Date, as a non-employee director, Dr. Lindborg will receive equity compensation paid by the Company pursuant to its Second Amended and Restated Director Compensation Plan, as amended. Pursuant to the Company’s Second Amended and Restated Director Compensation Plan, as amended, the Board expects to Dr. Lindborg will receive the following compensation for her service on the Board: (a) an initial grant of 6,666 shares of Restricted Stock for serving as a director; and (b) an annual award immediately following each annual meeting of stockholders of the Company consisting of either a nonqualified stock option to purchase 6,666 shares of the Company’s common stock, par value $0.00005 per share (“Common Stock”) or 6,666 shares of Restricted Stock for serving as a director. Every option and restricted stock award will vest monthly as to 1/12 the number of shares subject to the award over a period of twelve months, provided that Dr. Lindborg remains a member of the Board on each such vesting date.
Item 8.01. Other Events.
On April 16, 2024, the Company promoted Dr. Ibrahim B. Dagher, who had served as the Company’s Chief Development Officer since July 2023, to Executive Vice President and Chief Medical Officer of the Company.
On April 16, 2024, the Company issued a press release announcing (i) Dr. Linborg’s stepdown as the Co-Chief Executive Officer and her election to the Board and (ii) Dr. Dagher’s promotion to Executive Vice President and Chief Medical Officer. A copy of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| Exhibit | Description No. | |
| 99.1 | Press Release issued by Brainstorm Cell Therapeutics Inc., dated April 16, 2024 | |
| 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. | ||
| Date: April 16, 2024 | By: | /s/ Chaim Lebovits |
| Chaim Lebovits | ||
| Chief Executive Officer | ||
Exhibit 99.1
BrainStorm Cell Therapeutics Announces Management Changes as Company Plans Registrational Phase 3b Trial of NurOwn
Bob Dagher, MD, Promoted to Chief Medical Officer
Dr. Stacy Lindborg Stepping Down as Co-CEO and Transitioning to Board of Directors
NEW YORK, April 16, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the promotion of Dr. Bob Dagher to Executive Vice President and Chief Medical Officer. In addition, after four years of maintaining top executive roles, Dr. Stacy Lindborg stepping down from the role of Co-CEO and will remain with BrainStorm as a member of its Board of Directors. These strategic management changes are being made as the Company prepares to embark on a registrational Phase 3b trial for NurOwn®, its investigational cell therapy treatment for amyotrophic lateral sclerosis (ALS).
Dr. Dagher has served as our Chief Development Officer since July 2023. In his new role as Executive Vice President and Chief Medical Officer, Dr. Dagher’s responsibilities will include overseeing the planned Phase 3b registration trial of NurOwn. The Company recently announced that it has reached agreement with the U.S. Food & Drug Administration (FDA) for a Special Protocol Assessment (SPA) for this trial.
“With Bob’s promotion as CMO and Stacy’s addition to our Board, BrainStorm is well positioned for a smooth transition into a pivotal phase for the company and continued commitment to ALS,” said Chaim Lebovits, President and CEO of Brainstorm. “Bob’s capabilities, which include expertise in neurology, psychiatry, and rare diseases, make him exceptionally qualified as we launch the Phase 3b trial of NurOwn and prepare for success. We are fortunate to have someone of his caliber at the helm of our clinical efforts.”
Dr. Dagher commented, "I am honored to step into the role of Chief Medical Officer at such an important moment for BrainStorm. The opportunity to lead our talented clinical team through the upcoming Phase 3b trial is incredibly exciting. I am deeply committed to our mission and look forward to contributing to our success in bringing new treatments to patients and families affected by ALS."
Dr. Dagher has over 20 years‘ of experience in clinical research and development, with a proven track record of leading successful clinical trials and fostering innovation in drug development. Prior to joining Brainstorm he was Chief Medical Officer at Enveric Biosciences where he was responsible for defining the portfolio strategy and advancement of development plans toward regulatory approvals. He began his career in biopharmaceuticals as a medical scientist at GSK, and has served in leadership positions of science and medicine at companies such as Sanofi/Genzyme, and LabCorp/Covance. Dr. Dagher earned his medical degree at Bordeaux University and St. Joseph University School of Medicine, serving residencies in psychiatry and internal medicine at Boston University Medical Center. A past Diplomat of the American Board of Neurology and Psychiatry, he is licensed to practice medicine in Massachusetts.
“I strongly believe in the company's mission and commitment to ALS and I have great faith in the potential of debamestrocel to make life better for those living with ALS and their families,” said Stacy Lindborg, co-Chief Executive Officer. “I have great confidence in Bob as the leader of the Phase 3b program, and in the entire leadership teams’ dedication to move this product forward. I’m pleased to continue working with all my Brainstorm colleagues in my new capacity on Brainstorm’s Board of Directors.”
Mr. Lebovits concluded, “I would like to thank Stacy for her outstanding commitment and achievements at BrainStorm She excelled as a leader and talented scientist dedicated to patients. We are very pleased that she will continue to be involved in Brainstorm as a member of our Board of Directors and look forward to her contributions and strategic insights in this new role.”
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.
CONTACTS
Media:
Lisa Guiterman
Phone: +1 202-330-3431
lisa.guiterman@gmail.com
IR:
Michael Wood
Phone: +1 646-597-6983
mwood@lifesciadvisors.com