---
schema_version: "secwatch.filing_event.v1"
accession: "0001708599-25-000105"
form_type: "8-K"
ticker: "SER"
cik: "0001708599"
company_name: "Serina Therapeutics, Inc."
filed_at: "2025-08-25T23:59:59+00:00"
generated_at: "2026-05-17T10:15:25.857722+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA feedback supports registrational trial for SER-252 in advanced Parkinson's under 505(b)(2) NDA pathway

## Summary
- FDA Type B meeting written feedback supports advancing SER-252 (POZ-apomorphine) in registrational study.
- Plans to submit U.S. IND in Q4 2025; patient dosing in Australia expected to start in Q4 2025.
- U.S. enrollment expected to begin in Q1 2026 after IND clearance.
- SER-252-1b study is randomized, double-blind, placebo-controlled Phase 1b with up to 88 patients.
- CEO highlights capital-efficient 505(b)(2) pathway; platform may apply to other POZ-enabled small molecules.

## SEC filing metadata
- accession: 0001708599-25-000105
- form_type: 8-K
- ticker: SER
- cik: 0001708599
- company_name: Serina Therapeutics, Inc.
- filed_at: 2025-08-25T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1708599/000170859925000105/0001708599-25-000105-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1708599/000170859925000105/ser-20250825.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001708599-25-000105
- JSON: https://secwatch.observer/filing/0001708599-25-000105.json
- Plain text: https://secwatch.observer/filing/0001708599-25-000105.txt

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