Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))

Key Inclusion Criteria:

1. Male or Female, age ≥18 to ≤75

2. Focal seizures, clinically defined as unilateral MTLE

3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs atappropriate doses

4. Currently on stable doses (at least 1 month prior to Screening) of approved ASDs

5. Single seizure focus confirmed within one hippocampus

6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focalseizures per 28-day period with objective manifestations or more severe types, overthe 6 months prior to the Screening Visit. (Phase 1/2 only)

7. Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior tothe Screening visit and over a prospective 10-week baseline period prior toRandomization (Phase 3 Only)

Key Exclusion Criteria:

1. Epilepsy due to other medical conditions and/or progressive neurologic disease

2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non-focal origin.

3. Significant other medical conditions which would impair safe participation

4. History of status epilepticus in the 3 years prior to screening.

5. Primary or secondary immunodeficiency

6. Suicide attempts in the past year 3 years

7. Severe psychiatric disorders

8. Prior lobectomy or LITT procedure

9. MRI indicating potential malignant lesion

10. Pregnancy, or currently breastfeeding.