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BrainStorm Cell Therapeutics Inc. develops autologous adult stem cell therapeutics for neurodegenerative diseases, with news centered on its investigational NurOwn® platform for amyotrophic lateral sclerosis. NurOwn uses bone marrow-derived mesenchymal stem cells expanded and differentiated ex vivo into neurotrophic factor-secreting MSC-NTF cells designed to deliver neurotrophic factors and immunomodulatory cytokines.
Company updates commonly cover financial results, private placements and working-capital actions, regulatory engagement with the FDA, manufacturing readiness and clinical development activities tied to the Phase 3b ENDURANCE study. Corporate updates also address the completed transition of BCLI common stock from Nasdaq listing to OTCQB quotation.
BrainStorm Cell Therapeutics (OTCQB:BCLI) will have its executive leadership participate in the 31st Dubai International Pharmaceuticals & Technologies Conference and Exhibition (DUPHAT), held August 25–27, 2026, at the Dubai World Trade Centre in Dubai, UAE.
Executive Chairman and former FDA Associate Commissioner Peter J. Pitts is scheduled to deliver two keynote addresses on establishing an FDA Abraham Accords Office and rethinking NIH grant models, and to moderate expert panels on translational pharmaceutical innovation and the emerging roles of pharmacists. In parallel, President and CEO Chaim Lebovits and the executive team plan meetings with regional health regulators, commercial distribution partners, and international investment groups to discuss the strategic positioning of NurOwn® and the planned initiation of the Phase 3b ENDURANCE trial under a Special Protocol Assessment with the U.S. FDA.
BrainStorm Cell Therapeutics (OTCQB:BCLI) reported Q2 2026 results and a corporate update, focused on advancing the Phase 3b ENDURANCE trial of NurOwn in ALS under an FDA Special Protocol Assessment. The study is planned to enroll about 200 patients in a 24-week randomized, placebo-controlled Part A followed by an open-label Part B, with ALSFRS-R change as the primary endpoint and Part A intended to support a new BLA.
In July 2026, BrainStorm appointed former FDA Associate Commissioner Peter J. Pitts as Executive Chairman and Chief Strategic Regulatory and Policy Officer to lead operations, partnerships, investor engagement, and regulatory strategy. The company completed private placements totaling $400,000 in May, bringing first-half 2026 capital raised to approximately $2.4 million. As of June 30, 2026, cash, cash equivalents, and restricted cash were about $0.2 million, with total assets of $0.788 million and a stockholders’ deficit of $11.597 million.
Q2 2026 research and development expenses were roughly $1.0 million, and general and administrative expenses were about $2.7 million. Net loss for the quarter was approximately $3.9 million, or $0.35 per share, compared with a $2.9 million loss, or $0.34 per share, in Q2 2025.
BrainStorm Cell Therapeutics (OTCQB:BCLI) announced a strategic leadership change, appointing Peter J. Pitts, co-founder of the Center for Medicine in the Public Interest and former FDA Associate Commissioner, as Executive Chairman and Chief Strategic Regulatory and Policy Officer. Pitts will immediately lead daily strategic operations, corporate partnerships, investor engagements, and clinical-regulatory pathways, with a primary mandate to drive the upcoming Phase 3b trial of NurOwn® under an active FDA Special Protocol Assessment (SPA), described as the first SPA ever granted for an ALS therapeutic candidate.
Long-time chairman Professor Jacob Frenkel, who has guided BrainStorm since 2007 and became Board Chairman in 2020, will transition to Senior Advisor. NurOwn®, the company’s lead investigational ALS therapy, has completed a Phase 3 trial, holds Orphan Drug designation in the U.S. and EU, and is being advanced toward the Phase 3b study under the SPA.
BrainStorm Cell Therapeutics (OTCQB:BCLI) announced publication of an article in the Journal of the Academy of Public Health calling for updated FDA regulatory approaches for ALS, rare diseases and regenerative medicine.
Co-authored by Peter J. Pitts and CEO Chaim Lebovits, it advocates wider use of tools such as biomarkers, surrogate endpoints, adaptive designs and Bayesian statistics, especially in fast-progressing, small-population diseases like ALS.
BrainStorm Cell Therapeutics (OTCQB:BCLI) appointed former FDA Associate Commissioner Peter J. Pitts to its Board of Directors, effective immediately. Pitts is a recognized expert in healthcare policy, regulatory science, and FDA governance.
His appointment coincides with preparations to initiate the Phase 3b ENDURANCE trial of NurOwn for ALS, planned under a recently executed FDA Special Protocol Assessment (SPA), described as the first SPA ever granted for an ALS therapeutic candidate, subject to securing necessary funding.
BrainStorm Cell Therapeutics (OTCQB:BCLI) entered into May 2026 private placement agreements generating $400,000 in gross proceeds, priced at $0.95 per share, a 37.6% premium to the prior close of $0.69. Investors receive 120% warrant coverage at a $1.45 exercise price with a five-year term.
Two placements totaling $200,000 closed May 11, 2026, and the final one closed May 18, 2026. These transactions follow a $2.0 million February 2026 raise, bringing H1 2026 capital raises to $2.4 million, which management aims to use as bridge financing ahead of the planned Phase 3b ENDURANCE trial.
BrainStorm Cell Therapeutics (OTCQB:BCLI) reported Q1 2026 results and an update on its NurOwn ALS program. The company is preparing the Phase 3b ENDURANCE trial, targeting about 200 earlier-stage ALS patients, with Part A intended to support a new BLA submission if successful.
Q1 2026 net loss was $2.1M vs. $2.9M in Q1 2025, with R&D at $0.8M and G&A at $1.3M. Cash, cash equivalents and restricted cash totaled about $0.2M on March 31, 2026. BrainStorm closed private placements totaling $2.2M in Q1 and early Q2 2026.
BrainStorm Cell Therapeutics (OTCQB: BCLI) reported full-year 2025 results and a corporate update on March 31, 2026. The company closed two private placements in February 2026 totaling $2.0 million and plans a Phase 3b ENDURANCE study of NurOwn for ALS.
Key 2025 figures: cash ~$0.3M at year-end, R&D $4.2M, G&A $5.8M, and net loss ~$10.3M. Expanded Access Program patients show prolonged survival (mean ~84 months; 5/10 alive).
Brainstorm Cell Therapeutics (OTCQB: BCLI) completed a second definitive private placement for $1.0 million, bringing February 2026 proceeds to $2.0 million.
Shares were priced at $0.60 with 120% warrant coverage at a $1.00 exercise price; funding will be drawn in up to eight staged installments to support working capital and preparatory work for a planned Phase 3b NurOwn trial.
Brainstorm Cell Therapeutics (OTCQB:BCLI) announced a $1.0 million strategic private placement priced at $0.60 per share, a premium to the $0.54 close on Feb 9, 2026. The deal includes 120% warrant coverage exercisable at $1.00 for five years.
Funding is split into two tranches ($500,000 received; $500,000 due within 30 days). The company must file resale registration within 45 days and said proceeds will support regulatory work, prepayments for the planned Phase 3b NurOwn trial in ALS, and general corporate purposes. An 8-K was filed Feb 13, 2026.