Senti Biosciences Says FDA Grants Regenerative Medicine Advanced Therapy Designation To SENTI-202 For Treatment Of R/R Hematologic Malignancies, Including AML

• RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner
• Second FDA designation for SENTI-202 this year, after Orphan Drug Designation, is supported by clinical data showing deep and durable complete remission rates combined with a well-tolerated safety profile
• Data released at the American Society of Hematology (ASH) Annual Meeting on December 8, 2025 showed 50% Overall Response Rate (ORR) and 42% Complete Remission (CR)/CRh at the Recommended Phase 2 Dose (RP2D), with 7.6 months median duration of composite Complete Remission across all patients

SOUTH SAN FRANCISCO, Calif., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (NASDAQ:SNTI) ("Senti Bio"), a clinical-stage biotechnology company developing next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to SENTI-202, the Company's potential first-in-class Logic Gated off-the-shelf chimeric antigen receptor natural killer (CAR-NK) investigational cell therapy, that is currently in development for the treatment of relapsed/refractory hematologic malignancies, including AML.