Brainstorm Cell Therapeutics I Stock Price, News & Analysis

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced that the FDA will review a Citizen Petition requesting a new evaluation of data supporting NurOwn®, their ALS treatment therapy. The company, while not involved in the petition's submission, welcomes this development as an opportunity to reaffirm NurOwn's potential effectiveness.

Key clinical findings include: statistically significant functional improvement in patients with baseline ALSFRS-R scores ≥35, preservation of two more ALSFRS-R points compared to placebo, and remarkable survival data showing median survival of 6.8 years in Expanded Access Program participants.

BrainStorm will proceed with its planned Phase 3b ENDURANCE trial under FDA Special Protocol Assessment while exploring potential regulatory pathways for NurOwn access.

BrainStorm Cell Therapeutics announced remarkable survival data from its Expanded Access Program (EAP) for NurOwn in ALS treatment. The study followed 10 participants who previously completed the Phase 3 trial. Key findings revealed that 90% of participants survived beyond 5 years from ALS symptom onset, significantly exceeding the typical 10% survival rate at this milestone. The median survival was 6.8 years, with 6 out of 10 patients still alive after 7 years. Participants started with a Mean ALSFRS-R score of 35.8 at baseline, which declined to 31.4 at the EAP start. The company views these results as strong support for their upcoming FDA-aligned Phase 3b trial, highlighting NurOwn's potential in extending ALS patient survival.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has signed a Letter of Intent with Minaris Advanced Therapies for manufacturing NurOwn®, its adult stem cell therapy for ALS treatment. The partnership will facilitate technology transfer and clinical trial manufacturing at Minaris' Allendale, New Jersey facility in preparation for BrainStorm's planned Phase 3b clinical trial.

This U.S.-based manufacturing collaboration complements BrainStorm's recent partnership with Pluri Inc. (Nasdaq: PLUR) in Israel, establishing a robust manufacturing network for NurOwn®. The strategic relationship aims to advance the clinical development of this therapy for ALS patients through a multicenter Phase 3b trial.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has received FDA clearance to begin a Phase 3b clinical trial of NurOwn® for treating ALS. The trial design was approved under a Special Protocol Assessment (SPA), confirming its suitability for a future Biologics License Application. The study will involve approximately 200 participants at leading academic medical centers, featuring a 24-week randomized, double-blind, placebo-controlled phase followed by a 24-week open-label extension where all participants will receive NurOwn®. The primary endpoint will measure changes in the ALS Functional Rating Scale-Revised (ALSFRS-R) from baseline to week 24.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) reported its Q1 2025 financial results and provided updates on its NurOwn® development program for ALS treatment. The company submitted an IND amendment to the FDA and plans to initiate a Phase 3b trial (ENDURANCE) designed to enroll 200 early-stage ALS patients across 15 clinical sites. The trial will evaluate changes in ALSFRS-R scores over 24 weeks. Financial highlights show cash position of $1.8 million, R&D expenses of $1.3 million (up from $1.0M in Q1 2024), and G&A expenses of $1.8 million (up from $1.5M). The company reported a reduced net loss of $2.9 million ($0.45 per share) compared to $3.4 million ($0.75 per share) in Q1 2024. Recent highlights include NurOwn data presentation at ISCT 2025 Meeting and biomarker insights presentation at the 2025 ALS Drug Development Summit.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) has rescheduled its Q1 2025 financial results release to post-market close on May 15, 2025, with an investor conference call now set for Monday, May 19, 2025, at 8:30 a.m. ET. The call will feature CEO Chaim Lebovits presenting a corporate update, joined by COO Haro Hartounian, CMO Bob Dagher, and Interim CFO Alla Patlis.

BrainStorm is developing adult stem cell therapies for neurodegenerative diseases, with its flagship NurOwn® platform using autologous mesenchymal stem cells to produce neurotrophic factor-secreting cells. The company has completed a Phase 3 trial for ALS and is preparing to launch a confirmatory Phase 3b trial under an FDA Special Protocol Assessment agreement. Additionally, BrainStorm has completed a Phase 2 trial for progressive MS and is advancing an allogeneic exosome-based platform.

BrainStorm Cell Therapeutics (NASDAQ: BCLI), a developer of adult stem cell therapeutics for neurodegenerative diseases, has scheduled its Q1 2025 financial results conference call for May 15, 2025, at 8:30 a.m. Eastern Time. The call will feature CEO Chaim Lebovits presenting a corporate update, joined by CMO Bob Dagher and Interim CFO Alla Patlis for a Q&A session.

Shareholders can submit questions in advance to q@brainstorm-cell.com by May 12, 2025, at 5:00 p.m. ET. The call will be accessible via toll-free (888-506-0062) and international (973-528-0011) numbers, with participant code 621608. A replay will be available for 14 days.

BrainStorm Cell Therapeutics (NASDAQ: BCLI) announced its participation in the 4th Annual ALS Drug Development Summit from May 12-14, 2025, in Boston. The company will present new insights on NurOwn, its investigational cell therapy for ALS. Key presentations include:

Dr. Netta Blondheim-Shraga will present cerebrospinal fluid biomarker findings suggesting NurOwn's multimodal mechanism of action. Dr. Bob Dagher will moderate a workshop on adaptive trial designs, while Mary Kay Turner will lead a panel on clinical trial access. The company is preparing to launch a Phase 3b trial of NurOwn under a Special Protocol Assessment (SPA) agreement with the FDA.

BrainStorm Cell Therapeutics announced that new pharmacogenomic data for their NurOwn® treatment will be presented at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in New Orleans.

The breakthrough findings focus on how the UNC13A genotype affects treatment response in ALS patients. This represents a first-of-its-kind pharmacogenomic analysis from the Phase 3 trial, exploring genetic factors that may predict treatment outcomes.

Key developments include:

• Preparation for launching a Phase 3b trial of NurOwn for early ALS treatment
• Positive FDA communication and IND amendment submission
• Implementation of SPA as agreed with the Agency

The presentation, scheduled for May 8, 2025, will detail debamestrocel's effect on clinical and biomarker endpoints by UNC13A genotype in the Phase 3 ALS trial.