---
schema_version: "secwatch.filing_event.v1"
accession: "0001854270-25-000069"
form_type: "8-K"
ticker: "SNTI"
cik: "0001854270"
company_name: "Senti Biosciences, Inc."
filed_at: "2025-06-18T23:59:59+00:00"
generated_at: "2026-05-19T03:25:12.717372+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Senti Bio receives FDA Orphan Drug Designation for SENTI-202 CAR NK therapy in AML

## Summary
- FDA granted Orphan Drug Designation to SENTI-202 for relapsed/refractory hematologic malignancies, including AML.
- SENTI-202 is a first-in-class Logic Gated CD33 OR FLT3 NOT EMCN CAR NK cell therapy.
- Phase 1 trial (NCT06325748) is ongoing; median survival for relapsed/refractory AML is 5.3 months.
- Designation provides tax credits, FDA fee exemptions, and potential 7-year market exclusivity.
- Approximately 20,800 new AML cases per year in the US, with 60% relapsing or dying within 12 months.

## SEC filing metadata
- accession: 0001854270-25-000069
- form_type: 8-K
- ticker: SNTI
- cik: 0001854270
- company_name: Senti Biosciences, Inc.
- filed_at: 2025-06-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1854270/000185427025000069/0001854270-25-000069-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1854270/000185427025000069/snti-20250618.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001854270-25-000069
- JSON: https://secwatch.observer/filing/0001854270-25-000069.json
- Plain text: https://secwatch.observer/filing/0001854270-25-000069.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.