PRECISION BIOSCIENCES INC

Partnered Programs

ECUR-506, being developed by iECURE, uses Precision BioSciences’ ARCUS nuclease and is being evaluated as a potentially curative treatment for neonatal onset OTC deficiency in the ongoing OTC-HOPE study. Recently, iECURE reached alignment with the U.S Food and Drug Administration (FDA) on the primary and key secondary efficacy endpoints, comparators and study size for the ongoing OTC-HOPE study which could support a Biologics License Application. In addition, ECUR-506 was granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for neonatal onset OTC deficiency. iECURE’s receipt of these regulatory milestones is supported by encouraging clinical data from the ongoing OTC-HOPE clinical study, including a complete clinical response observed in the first infant treated with ECUR-506. iECURE expects to release data from the ongoing clinical trial in the first half of 2026.

Azer-Cel, a novel allogeneic CAR T treatment originally created by Precision, is being developed by Imugene for diffuse large B-cell lymphoma. Imugene’s recent FDA discussions have reached clear alignment across key elements required to advance azer-cel into a pivotal study including dosing regimen, patient population, endpoints, and manufacturing readiness.

Precision received an $8 million milestone payment in the fourth quarter of 2025 as a result of Imugene’s progress with Azer-Cel.

Azer-Cel is also being developed by TG Therapeutics. Enrollment for patients with progressive multiple sclerosis is ongoing in a Phase 1 clinical trial evaluating azer-cel for the treatment of autoimmune diseases. Precision is eligible for additional milestone payments from TG Therapeutics, including a $7.5M near term clinical milestone.