Company: NCEL
Filing Date: 2025-02-10
Form Type: F-3
Source: 0001213900-25-011823
Chunk: 21

Company: NewcelX Ltd.
Filing Date: 2025-02-10
Form: F-3
Chunk 21
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 Jerusalem, Israel. Eligible participants were aged between 18
and 70 years with a diagnosis of probable or definite ALS by revised El Escorial Criteria, within two years of diagnosis. The ALS Functional
Rating Scale-Revised, or ALSFRS-R score was higher than 30, and slow vital capacity, or SVC, was 70% or more
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 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-19 in 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.

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Safety outcomes: Nine out
of 10 (90%) of treated patients completed the six-month follow-up, and 6 patients (60%) completed the twelve-month follow-up. All patients
reported a total of 86 treatment-emergent adverse 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