---
schema_version: "secwatch.filing_event.v1"
accession: "0001654954-24-001299"
form_type: "8-K"
ticker: "AIMD"
cik: "0001014763"
company_name: "Ainos, Inc."
filed_at: "2024-02-05T23:59:59+00:00"
generated_at: "2026-06-06T08:54:55.119983+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Ainos submits clinical hold complete response to FDA for VELDONA Phase 2 COVID-19 trial

## Summary
- Submitted clinical hold complete response to FDA for Phase 2 trial of low-dose oral IFN-alpha VELDONA for mild COVID-19.
- Phase 2 multicenter randomized study expected in Taiwan in Q3 2024 if approved.
- Updated CMC and stability data show VELDONA can exceed minimum shelf life for biologicals.
- Plans additional IND applications in H2 2024 for oral warts (orphan drug) and Sjögren's syndrome.
- Low-dose oral VELDONA safety demonstrated in ~6,000 subjects across 68 clinical trials.

## SEC filing metadata
- accession: 0001654954-24-001299
- form_type: 8-K
- ticker: AIMD
- cik: 0001014763
- company_name: Ainos, Inc.
- filed_at: 2024-02-05T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1014763/000165495424001299/0001654954-24-001299-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1014763/000165495424001299/aimd_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001654954-24-001299
- JSON: https://secwatch.observer/filing/0001654954-24-001299.json
- Plain text: https://secwatch.observer/filing/0001654954-24-001299.txt

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