Item 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers. On May 25, 2026, the Board of Directors (the “ Board ”) of Brainstorm Cell Therapeutics Inc. (the “ Company ”) approved an increase in the number of directors constituting the Board from seven to eight directors and appointed Peter Pitts to serve as a director of the Company, effective as of the same day, to serve until the Company’s 2026 Annual Meeting of Stockholders and until his successor is duly elected and qualified. Mr. Pitts, age 67, has served as the President of the Center for Medicine in the Public Interest since 2004. Mr. Pitts has served as a Visiting Professor at the University of Paris School of Medicine since 2015. From 2001 through 2003, Mr. Pitts served as a member of the United States Senior Executive Service, and from 2001 through 2003, he was Associate Commissioner of the US Food & Drug Administration, where he served as senior communications and policy adviser to the Commissioner. Mr. Pitts has served as a member of the Council for International Organizations of Medical Sciences Expert Working Group to help advance patient involvement in the development and safe use of medicines since 2020. From 1997 though 2000, Mr. Pitts served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs. Mr. Pitts has over 30 years of experience in health care public policy, and is lead author of multiple peer-reviewed publications. Mr. Pitts has a BA degree from McGill University. The Company will enter into a standard indemnification agreement with Mr. Pitts, a form of which is filed as Exhibit 10.1 to this Current Report on Form 8-K. The Board also issued Mr. Pitts, upon his appointment to the Board, an option to purchase up to 150,000 shares of the Company’s common stock, which was consistent with the one-time grants made to the members of the Board in 2026 prior to the appointment of Mr. Pitts. Half of the options vested upon issuance, and the remaining half will vest on the six-month anniversary of their issuance. Mr. Pitts will also be eligible to participate in the Company’s annual non-employee director compensation program if and when the Board re-establishes that program. The Board determined that Mr. Pitts is “independent” as defined under the applicable SEC rules and regulations and the Company’s corporate governance guidelines. There are no family relationships between Mr. Pitts and any director or executive officer of the Company. There are no arrangements or understandings between Mr. Pitts and any other persons or entities pursuant to which Mr. Pitts was appointed as director of the Company, and there are no transactions involving Mr. Pitts, on the one hand, and the Company, on the other hand, that would require disclosure under Item 404(a) of Regulation S-K.
BCLI Brainstorm Cell Therapeutics Inc. - 8-K
Accession
0001104659-26-0674745.027.019.01
Item 5.02 - Departure/Election of Directors or Certain Officers
472 words
Item 7.01 - Regulation FD Disclosure
135 words · Exhibit 99.1 attached
Item 7.01 Regulation FD Disclosure. The Company issued a press release on May 28, 2026, regarding Mr. Pitts’ appointment to the Board. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein solely for purposes of this Item 7.01 disclosure. Such press release shall not be deemed “filed” for any purpose, including for the 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. The information in this Item 7.01, as well as Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act regardless of any general incorporation language in such filing.
Exhibit 99.1 · 1,095 words
EX-99.1 3 tm2615772d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 BrainStorm Cell Therapeutics Appoints Former FDA Associate Commissioner Peter J. Pitts to Board of Directors Former Senior FDA Official Joins Board as Company Prepares to Initiate Historic Phase 3b ALS Trial Under Special Protocol Assessment NEW YORK, NY - May 28, 2026 - BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of autologous stem cell therapies for neurodegenerative diseases, today announced that Peter J. Pitts has been appointed to the Company’s Board of Directors, effective immediately. Mr. Pitts is a globally recognized expert in healthcare policy, regulatory science, and U.S. Food and Drug Administration (FDA) governance. He previously served as Associate Commissioner at the FDA and as a member of the U.S. Senior Executive Service. His appointment comes as BrainStorm prepares to, upon acquisition of necessary funding, initiate its Phase 3b ENDURANCE trial evaluating NurOwn® for ALS under a recently executed FDA Special Protocol Assessment (SPA), the first SPA ever granted for an ALS therapeutic candidate. “BrainStorm is conducting some of the most important and scientifically rigorous work in neurodegenerative medicine today,” said Pitts. “The FDA’s Special Protocol Assessment for this Phase 3b trial is unprecedented in ALS and sends a powerful signal that the agency recognizes both the seriousness of the disease and the strength of the trial design.” “Just as importantly, the FDA is now under new management - and we believe that creates a far greater opportunity for smart regulatory innovation, serious scientific engagement, and patient-focused flexibility than we’ve seen in recent years. Patients with terminal ALS do not have the luxury of bureaucratic drift or ideological grandstanding. They need urgency, rigor, and leadership.” “For too long, portions of the FDA confused caution with paralysis. With new leadership now in place, there is renewed opportunity for regulatory creativity grounded in science rather than institutional defensiveness. ALS patients cannot afford performative skepticism from regulators sitting comfortably outside the blast radius of this disease.” “I look forward to working with Chaim Lebovits, the Board, and leading ALS centers around the country to help ensure that sound science, regulatory common sense, and a relentless focus on patients bring this promising therapy across the finish line.” Chaim Lebovits, President and Chief Executive Officer of BrainStorm, added, “We are honored to welcome Peter Pitts to the BrainStorm Board at this defining moment for our Company and for the ALS community. Peter’s unparalleled regulatory expertise, credibility, and commitment to patients will be invaluable as we initiate the Phase 3b ENDURANCE trial under our Special Protocol Assessment granted by the FDA.” Mr. Pitts currently serves as President and co-founder of the Center for Medicine in the Public Interest (CMPI). His commentaries on regulatory science and healthcare reform have appeared in The Wall Street Journal , The New York Times , and The Washington Post , and his peer-reviewed work has been published in leading journals including The Lancet , JAMA , and NEJM Catalyst . About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (OTCQB: 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 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. Logo: https://mma.prnewswire.com/media/1166536/BrainStorm_Logo.jpg CONTACTS: Investors Michael Wood Phone: +1 646-597-6983 [email protected] Media Uri Yablonka Chief Business Officer Phone: +1 917-284-2911 [email protected] SOURCE BrainStorm Cell Therapeutics Inc.
Item 9.01 - Financial Statements and Exhibits
42 words
Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit No. Description 10.1 Form of Director Indemnification Agreement 99.1 Press Release issued by Brainstorm Cell Therapeutics Inc. on May 28, 2026. 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)