On Jun. 16, 2025, BrainStorm Cell Therapeutics announced new survival data from 10 participants in its Expanded Access Program (EAP) for NurOwn^® (autologous MSC-NTF cells) in amyotrophic lateral sclerosis (ALS). The EAP enrolled 10 participants who had previously completed the Phase 3 clinical trial.

The analysis reviewed survival from the time of first symptom onset through participation in the Phase 3 trial, EAP Periods 1 and 2, followed by additional survival data collected through publicly available records.

EAP participants presented at the start of the Phase 3 trial relatively early in their disease course, with Mean ALSFRS-R at Baseline of 35.8 (Range: 32 – 40), followed by Mean ALSFRS-R at the start of the EAP of 31.4 (Range: 27 – 38; with one outlier score of 13).

90% of participants (9/10) survived more than five years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS survive beyond five years. Notably, the single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years (range: 6 to 7 years) from symptom onset.

The NurOwn EAP was designed to provide compassionate access to NurOwn for eligible ALS participants who completed the Phase 3 trial. The observed durability of survival in this cohort, as reflected in the publicly sourced survival data, underscores the importance of advancing the upcoming registrational Phase 3b controlled clinical trial.