Achieve Life Sciences, Inc.

Achieve Life Sciences, Inc. (ACHV), a clinical-stage biopharmaceutical company developing cytisinicline for nicotine addiction, reported a net loss of $54.6 million for FY 2025 ended December 31, 2025, driven by elevated operating expenses amid commercialization preparations. With no revenue generated, total operating expenses reached $54.9 million, comprising research and development (R&D) costs of $23.0 million (up from $22.8 million in 2024, due to higher employee and manufacturing costs offset by lower clinical trial expenses) and general and administrative (G&A) expenses of $31.9 million (up from $16.3 million, primarily from $12.3 million in commercial launch costs and $2.7 million higher stock-based compensation). Other income netted $232K, including $1.5 million interest income (down from $2.4 million) and $819K interest expense (down from $2.2 million). Basic and diluted EPS was -$1 on 43.6 million shares. Net cash used in operations increased to $49.5 million from $29.8 million YoY, financed by $51.5 million from financing activities (up slightly from $48.5 million), yielding $36.4 million in cash, equivalents, and marketable securities at year-end and $30.8 million positive working capital. Despite NDA acceptance by FDA, substantial doubt exists on going concern due to insufficient funds for 12+ months, necessitating additional capital for regulatory approval and launch.

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