SNTI News & Events

Senti Bio announced the successful completion of a Type B Initial Comprehensive Multidisciplinary Regenerative Medicine Advanced Therapy, or RMAT, meeting with the FDA regarding SENTI-202, the company's Logic Gated off-the-shelf CAR-NK cell therapy for relapsed/refractory acute myeloid leukemia and updated Phase 1 clinical data. Following the RMAT meeting, the company has finalized its pivotal clinical and chemistry, manufacturing and controls strategy for SENTI-202. The company plans to implement a single-arm, multi-center pivotal trial intended to support potential SENTI-202 registration in patients with R/R AML. This study is expected to evaluate SENTI-202 administered following lymphodepletion chemotherapy in a patient population consistent with the Phase 1 trial population. In addition to the RMAT meeting, after conducting exploratory efficacy covariate analysis of the Phase 1 trial results, Senti has identified a specific Donor X attribute that correlates with efficacy of SENTI-202, with 50% of the patients achieving a cCR when they received any SENTI-202 doses manufactured from Donor X-characteristic-derived NK cells in Cycle 1 versus 12.5% achieving a cCR when they received SENTI-202 manufactured from non-Donor X NK cells. As a result of this discovery, all future SENTI-202 manufacturing, including for pivotal study use, will use Donor X material. The Donor X attribute is found in ~50% of adult donors, and published literature supports increased NK cell cytotoxicity in donors with this phenotype. The Donor X NK phenotype is independent of HLA or KIR matching, thus supporting SENTI-202's allogeneic off-the-shelf usage. Retrospective analysis of preclinical MV4-11 NSG mouse model data confirmed increased activity and survival with Donor X product. Senti Bio also announced that SENTI-202 continues to exhibit durable MRD-negative responses in the full 22 patient Phase 1 trial, which compares favorably with current FDA approved therapies for R/R AML. At RP2D, across all patients receiving a mix of Donor X and non-Donor X material, an ORR of 44% and cCR of 37.5% was observed with 100% of CRs being MRD negative. The complete remissions continue to be durable, with all the CR/CRh responders who were in remission as of the data-cut supporting the oral presentation at the 2025 ASH annual meeting continuing to maintain remission with an additional 7 months of follow up, the longest duration being 21+ months.

"We entered 2026 with a clear focus on advancing SENTI-202 and extending our operational runway while positioning the company for its next phase of clinical development," said Timothy Lu, Chief Executive Officer and Co-Founder of Senti Bio. "Since the start of the year, we have made meaningful progress across each of these priorities, including a positive regulatory engagement with the FDA on SENTI-202 - a Regenerative Medicine Advanced Therapy designated product - regarding the study design for the planned pivotal trial, execution of a strategic financing agreement that could provide up to $40 million in capital, and continued reductions in operating expenses and cash burn."

Reports Q4 revenue $22,000, consensus $500,000. "2025 was a year of important progress for Senti as we continued to advance our mission of developing next-generation cell and gene therapies powered by our synthetic biology platform. Over the past year, we have strengthened the clinical and translational foundation of our pipeline, with SENTI-202 as the lead program generating positive clinical data, while continuing to refine and expand the capabilities of our Gene Circuit platform. We remain focused on disciplined execution, advancing our key programs toward critical development milestones and positioning Senti to deliver smarter, more selective medicines for patients with serious diseases. I am proud of our team's commitment and believe the progress we made in 2025 positions us well for the opportunities ahead," commented Timothy Lu, co-founder and CEO of Senti Biosciences.

Senti Biosciences announced the completion of enrollment in its Phase 1 clinical trial evaluating SENTI-202, a first-in-class CD33/FLT3-targeting Logic Gated CAR NK cell therapy, in patients with relapsed or refractory acute myeloid leukemia. "The completion of enrollment in our Phase 1 trial represents a significant clinical milestone for our SENTI-202 program," said Kanya Rajangam, M.D., Ph.D. Chief Medical Officer at Senti Bio. "Importantly, the encouraging clinical data from this study provide a strong foundation as we actively design our pivotal program for SENTI-202 in AML, as well as potential indication expansion and later-stage clinical development. We look forward to having productive discussions and working closely with the FDA in the first half of this year to discuss the next phase of development for our RMAT-designated program."