Achieve Life Sciences reports 2023 net loss of $29.8M; FDA agrees on NDA path for cytisinicline

ACHIEVE LIFE SCIENCES, INC.

Net loss Q4 2023: $5.5M; full-year 2023 net loss: $29.8M; operating expenses $27.3M.
Cash $15.6M at Dec 31, 2023; pro forma $71.8M after Feb 2024 equity financing of up to $124.2M.
FDA agreed single open-label safety study (ORCA-OL) is sufficient; NDA submission expected H1 2025.
Phase 3 ORCA-2/3 and Phase 2 ORCA-V1 data at SRNT: 69% of cytisinicline users quit smoking; 97% would recommend.
Shares outstanding as of March 28, 2024: 34,251,911.

Key facts

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

ACHIEVE LIFE SCIENCES, INC. reported fourth quarter and year ended December 31, 2023 results: net income $5.5 million and $29.8 million.

Period: fourth quarter and year ended December 31, 2023
Net income: $5.5 million and $29.8 million
Result: reported results

Exact text from the filing

Total net loss for the fourth quarter and year ended December 31, 2023 was $5.5 million and $29.8 million, respectively.

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Source: SEC EDGAR

accession 0000950170-24-038030

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