---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-23-128806"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2023-12-22T23:59:59+00:00"
generated_at: "2026-06-07T07:58:32.217384+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics reports FY2023 net loss of $59M, reiterates ONS-5010 path with NORSE EIGHT trial start in Q1 2024

## Summary
- Net loss of $59.0M ($0.24 per share) for FY2023, vs. $66.1M ($0.31 per share) prior year.
- Cash and equivalents $23.4M as of Sept 30, 2023; extended convertible note maturity to April 1, 2024.
- FDA response on NORSE EIGHT SPA expected early Feb 2024; trial start targeted Q1 2024.
- MAA decision in EU for ONS-5010 (LYTENAVA) anticipated first half 2024; BLA resubmission expected by end of 2024.
- Exploring expanded relationship with Cencora for international launch; Syntone partnership in China continues.

## SEC filing metadata
- accession: 0001104659-23-128806
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2023-12-22T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/0001104659-23-128806-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/tm2333600d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-23-128806
- JSON: https://secwatch.observer/filing/0001104659-23-128806.json
- Plain text: https://secwatch.observer/filing/0001104659-23-128806.txt

## Key facts
- Earnings Releases
  Outlook Therapeutics, Inc. updated its guidance (reaffirmed).
  - Guidance: reaffirmed
  - Result: guidance update
  source text: Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU
  evidence_url: https://www.sec.gov/Archives/edgar/data/1649989/000110465923128806/0001104659-23-128806-index.htm

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