Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 409

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 409
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 of the predicted normal value for height, age, and sex. Participants were either not receiving riluzole and/or edaravone or were on a stable dose for more than 30 days. Potential patients were excluded for the following reasons: past infection or a positive test for hepatitis B, hepatitis C or HIV (human immunodeficiency virus), need for respiratory support, renal failure, impaired hepatic function, body mass index under 18.5 or 30 or above, significant cardiac disease, diabetes, autoimmune diseases, chronic severe infection, malignant disease or any other disease or condition that may risk the patient or interfere with the result of the study. By the end of December 2019, ten patients were treated with AstroRx ®: five patients from Cohort A had been treated with 100 million AstroRx ®cells injected into their spinal fluid. Subsequently, five patients from Cohort B were treated with 206 250 million AstroRx ®cells, with the last patient being treated in December 2019. During 2020, clinical data was collected for the treated patients for up to 12 months. Considering the spread of COVID -19in Israel and following the data and safety monitoring board recommendation to suspend the continuation of the clinical trial in the third and fourth treatment groups, Kadimastem decided to discontinue the recruitment to additional treatment groups in ALS Phase 1/2a trial. Safety outcomes: Nine out of 10 (90%) of treated patients completed the six -monthfollow -up, and 6 patients (60%) completed the twelve -monthfollow -up. All patients reported a total of 86 treatment -emergentadverse events, or TEAE. None of the TEAEs was deemed to be associated with AstroRx ®itself. 63 TEAEs were mild, 19 were moderate, and 4 were severe. Six patients developed a total of 9 serious TEAEs after the treatment, 2 patients in Group A and 4 patients in Group B. The most frequent TEAE was post lumbar puncture headache, associated with IT injection procedure of the cells, and reported by 50% of the patients. Additional procedure -relatedTEAEs included pain in the injection site (30%), arthralgia, back pain, muscle contraction, and pain in the leg, each reported by 10% of the patients. All procedure -relatedadverse events, or AEs, were graded as mild to moderate, and all were resolved.