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

Outlook Therapeutics, Inc.

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.

item 2.02 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Earnings Releases SEC 8-K Item 2.02 confidence 0.7

Outlook Therapeutics, Inc. updated its guidance (reaffirmed).

Guidance: reaffirmed
Result: guidance update

Exact text from the filing

Outlook Therapeutics® Reports Financial Results for Fiscal Year 2023 and Reiterates ONS-5010 Clinical and Regulatory Path Forward in the U.S. and EU

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Outlook Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001104659-23-128806

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