---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-062054"
form_type: "8-K"
ticker: "OTLK"
cik: "0001649989"
company_name: "Outlook Therapeutics, Inc."
filed_at: "2024-05-15T23:59:59+00:00"
generated_at: "2026-06-01T23:15:21.663886+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Outlook Therapeutics reports Q2 FY2024 net loss of $114.3M; positive CHMP opinion for ONS-5010 in EU

## Summary
- Net loss of $114.3M ($8.01/sh); adjusted net loss of $22.1M ($1.55/sh) vs $6.7M loss year ago.
- CHMP issued positive opinion for ONS-5010/LYTENAVA in EU; EC decision expected within ~67 days.
- NORSE EIGHT trial >30% enrolled; topline readout planned in Q4 CY2024; BLA resubmission by end of CY2024.
- UK MAA submitted under International Recognition Procedure.
- Company believes sufficient capital to fund potential FDA approval and commercial launch assuming warrant exercise.

## SEC filing metadata
- accession: 0001104659-24-062054
- form_type: 8-K
- ticker: OTLK
- cik: 0001649989
- company_name: Outlook Therapeutics, Inc.
- filed_at: 2024-05-15T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/0001104659-24-062054-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/tm2414392d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-062054
- JSON: https://secwatch.observer/filing/0001104659-24-062054.json
- Plain text: https://secwatch.observer/filing/0001104659-24-062054.txt

## Key facts
- Earnings Releases
  Outlook Therapeutics, Inc. reported financial results for second quarter of fiscal year 2024.
  - Period: second quarter of fiscal year 2024
  - Result: reported results
  source text: Outlook Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for its second fiscal quarter ended March 31, 2024
  evidence_url: https://www.sec.gov/Archives/edgar/data/1649989/000110465924062054/0001104659-24-062054-index.htm

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