CLLS · Cellectis S.A.

Cellectis announced positive interim futility analysis results from Allogene Therapeutics' sponsored ALPHA3 pivotal Phase 2 trial of cema-cel, an allogeneic anti-CD19 CAR-T therapy originally derived from Cellectis' UCART19, in first-line consolidation for large B-cell lymphoma. The analysis, triggered at the 24th patient reaching Day 45 MRD assessment, demonstrated 58.3% MRD negativity in the cema-cel arm versus 16.7% in the observation arm, a 41.6% absolute difference surpassing Allogene-cited literature benchmarks of 25-30% that could indicate meaningful clinical benefit at study end. Safety data further supports the platform's profile, with no instances of CRS, ICANS, GvHD, or treatment-related serious adverse events, most patients managed outpatient, and no treatment-related hospitalizations. CEO André Choulika emphasized this as validation of Cellectis' pioneering allogeneic 'off-the-shelf' CAR-T vision, potentially displacing autologous therapies by addressing speed, accessibility, and consistency challenges. Under the Servier Agreement, Cellectis stands to gain up to $340 million in development and sales milestones plus low double-digit royalties on cema-cel net sales in LBCL. Allogene projects trial accrual completion by end-2027, interim EFS analysis mid-2027, and primary EFS mid-2028, with positive results possibly enabling BLA submission. This milestone underscores the strength of Cellectis' gene-editing platform and in-house manufacturing, positioning it for broader oncology applications while highlighting partnered program value for investors.