secwatch.observer — SEC 8-K summary
======================================

Issuer:     LeonaBio, Inc. (LONA)
CIK:        0001620463
Form:       8-K
Filed at:   2024-09-03T23:59:59+00:00
Accession:  0000950170-24-102788
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 8.01, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/0000950170-24-102788-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1620463/000095017024102788/atha-20240903.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-102788

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer