---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-252714"
form_type: "8-K"
ticker: "AURA"
cik: "0001501796"
company_name: "Aura Biosciences, Inc."
filed_at: "2022-09-28T23:59:59+00:00"
generated_at: "2026-06-23T06:57:50.643367+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Aura Biosciences doses first patient in Phase 1 study of AU-011 for bladder cancer

## Summary
- First patient dosed in Phase 1 study of belzupacap sarotalocan (AU-011) for non-muscle invasive bladder cancer (NMIBC).
- Phase 1 open-label trial to enroll approximately 23 adults; primary endpoint safety/tolerability.
- Initial Phase 1 data expected in 2023; CMO notes no major advances in NMIBC in over two decades.
- FDA granted Fast Track designation for AU-011 in NMIBC in June 2022.
- Approximately 70% of bladder cancer patients are diagnosed early with NMIBC (global).

## SEC filing metadata
- accession: 0001193125-22-252714
- form_type: 8-K
- ticker: AURA
- cik: 0001501796
- company_name: Aura Biosciences, Inc.
- filed_at: 2022-09-28T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1501796/000119312522252714/0001193125-22-252714-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1501796/000119312522252714/d363970d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-252714
- JSON: https://secwatch.observer/filing/0001193125-22-252714.json
- Plain text: https://secwatch.observer/filing/0001193125-22-252714.txt

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