secwatch.observer — SEC 8-K summary
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Issuer:     Outlook Therapeutics, Inc. (OTLK)
CIK:        0001649989
Form:       8-K
Filed at:   2023-05-15T23:59:59+00:00
Accession:  0001104659-23-060850
Event type: earnings
Sentiment:  neutral
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Outlook Therapeutics reports Q2 net loss $6.7M; PDUFA date Aug 29 for ONS-5010
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- Net loss $6.7M ($0.03/sh) vs $19.7M ($0.09) in prior-year Q2.
- Cash $43.7M as of March 31, 2023; expects to fund ops through potential approval in Q3/Q4 2023.
- PDUFA goal date Aug 29, 2023 for ONS-5010 (bevacizumab) for wet AMD.
- Pre-launch commercial activities ongoing; partnership with AmerisourceBergen for distribution.
- MAA for ONS-5010 under EU review; CHMP decision expected early 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649989/000110465923060850/0001104659-23-060850-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649989/000110465923060850/tm2315802d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-060850

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer