---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-102788"
form_type: "8-K"
ticker: "LONA"
cik: "0001620463"
company_name: "LeonaBio, Inc."
filed_at: "2024-09-03T23:59:59+00:00"
generated_at: "2026-05-31T06:37:58.620171+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.9
calibrated_materiality_score: 0.9
confidence: "high"
source: SEC EDGAR
---

# Athira's Phase 2/3 LIFT-AD trial of fosgonimeton misses primary endpoint; biomarker data mixed

## Summary
- Primary endpoint GST (p=0.70) and key secondary endpoints ADAS-Cog11 (p=0.35) and ADCS-ADL23 (p=0.61) not met; directionally favored fosgonimeton.
- Prespecified subgroups (moderate AD, APOE4 carriers) showed numerically greater treatment effects; e.g., moderate AD ADAS-Cog11 delta -1.16 (p=0.39).
- Biomarker p-Tau217 significantly reduced (p<0.01); NfL, GFAP, Aβ42/40 improved directionally.
- Preliminary cash resources ~$75.1M as of Aug 31, 2024; ATH-1105 Phase 1 ongoing, completion expected by year-end 2024, ALS patients targeted for 2025.
- Fosgonimeton well tolerated; SAEs similar to placebo; 22% early termination rate; full results to be presented at CTAD Oct 29-Nov 1, 2024.

## SEC filing metadata
- accession: 0000950170-24-102788
- form_type: 8-K
- ticker: LONA
- cik: 0001620463
- company_name: LeonaBio, Inc.
- filed_at: 2024-09-03T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.9
- calibrated_materiality_score: 0.9
- confidence: high
- sec_items: 8.01, 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/0000950170-24-102788-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/atha-20240903.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-102788
- JSON: https://secwatch.observer/filing/0000950170-24-102788.json
- Plain text: https://secwatch.observer/filing/0000950170-24-102788.txt

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