---
schema_version: "secwatch.filing_event.v1"
accession: "0001171843-24-006545"
form_type: "8-K"
ticker: "FLNA"
cik: "0001069530"
company_name: "FILANA THERAPEUTICS, INC."
filed_at: "2024-11-25T23:59:59+00:00"
generated_at: "2026-05-29T18:35:47.901332+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 1.0
calibrated_materiality_score: 1.0
confidence: "high"
source: SEC EDGAR
---

# Cassava Sciences simufilam Phase 3 Alzheimer's trial misses all endpoints; studies halted

## Summary
- Simufilam failed to meet co-primary endpoints: ADAS-COG12 delta -0.39 (p=0.43), ADCS-ADL delta 0.51 (p=0.40).
- Company discontinues Phase 3 ReFocus-ALZ and open-label extension studies due to failed ReThink-ALZ results.
- Simufilam showed favorable safety profile; serious AEs 13.0% vs 9.0% placebo; 1 death vs 3 in placebo.
- Cash and equivalents approx $149M as of Q3 2024; company to evaluate next steps and present data at medical meeting.
- Patient demographics balanced; mild-to-moderate AD enrollment; placebo decline less pronounced than expected.

## SEC filing metadata
- accession: 0001171843-24-006545
- form_type: 8-K
- ticker: FLNA
- cik: 0001069530
- company_name: FILANA THERAPEUTICS, INC.
- filed_at: 2024-11-25T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 1.0
- calibrated_materiality_score: 1.0
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000117184324006545/0001171843-24-006545-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1069530/000117184324006545/f8k_112524.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001171843-24-006545
- JSON: https://secwatch.observer/filing/0001171843-24-006545.json
- Plain text: https://secwatch.observer/filing/0001171843-24-006545.txt

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