---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-120329"
form_type: "8-K"
ticker: "TSHA"
cik: "0001806310"
company_name: "Taysha Gene Therapies, Inc."
filed_at: "2025-05-15T23:59:59+00:00"
generated_at: "2026-05-21T05:31:46.267399+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Taysha secures FDA alignment on TSHA-102 pivotal trial design; Q1 net loss $21.5M

## Summary
- FDA alignment on pivotal Part B trial design; IND amendment with protocol/SAP expected Q2 2025, potentially expediting registration.
- TSHA-102 well tolerated: no treatment-related SAEs or DLTs in 10 patients (6 high dose, 4 low dose) as of April 10, 2025 cutoff.
- Q1 2025 net loss $21.5M ($0.08/sh) vs $24.1M ($0.10/sh) in Q1 2024; cash $116.6M expected into Q4 2026.
- R&D expenses $15.6M, down from $20.7M YoY due to lower manufacturing costs; G&A expenses $8.2M, up from $7.1M.

## SEC filing metadata
- accession: 0001193125-25-120329
- form_type: 8-K
- ticker: TSHA
- cik: 0001806310
- company_name: Taysha Gene Therapies, Inc.
- filed_at: 2025-05-15T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1806310/000119312525120329/0001193125-25-120329-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1806310/000119312525120329/d89129d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-120329
- JSON: https://secwatch.observer/filing/0001193125-25-120329.json
- Plain text: https://secwatch.observer/filing/0001193125-25-120329.txt

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