0001193125-26-120690
SEC filingAchieve 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.
Achieve Life Sciences reported a FY 2025 net loss of $54.6 million, or -$1 per basic and diluted share on 43.6 million weighted average shares, compared to prior year where component increases suggest higher losses. Comprehensive loss was $54.7 million. No revenue was recorded as the company advances cytisinicline toward FDA approval. Operating expenses totaled $54.9 million, up YoY: R&D at $23.0 million (from $22.8 million, driven by headcount and manufacturing for launch prep, offset by ORCA-OL trial wind-down) and G&A at $31.9 million (from $16.3 million, due to $12.3 million commercial costs vs. $1.2 million prior and $2.7 million more stock-based compensation). Other income/expense netted $232K, with interest income $1.5 million (down from $2.4 million on lower cash/rates), interest expense $819K (down from $2.2 million post-debt refinance), $408K gain on contingent consideration, and -$283K loss on debt extinguishment. Accumulated deficit reached $260.2 million. Total assets $41.8 million, equity $21.5 million.
Achieve Life Sciences generated no product revenue in FY 2025, consistent with its pre-commercial status. The company relies on equity/debt financings and grants, with a grant receivable noted but no recognized revenue. Focus remains on cytisinicline development and NDA filing accepted by FDA in 2025. No segment or geographic revenue breakdown disclosed.
Pre-revenue, no gross or operating margins applicable. Operating loss equated to total expenses of $54.9 million. Profitability pressured by R&D/G&A increases, partially mitigated by lower interest expense post-SVB debt refinance and higher stock compensation. Stock-based compensation totaled $8.8 million in cash flow adjustments. Contingent consideration fair value change yielded $408K gain. Expenses expensed as incurred per policy, including inventory costs pre-approval.
Net cash used in operations was $49.5 million (up from $29.8 million YoY), adjusted for $8.8 million stock compensation, $228K depreciation, and working capital changes like -$709K accrued clinical and -$1.1M accrued compensation. Financing provided $51.5 million (from $48.5 million YoY), including $4.0 million June 2025 offering overallotment, $1.4M warrant exercises, $9.8M + $5.0M SVB loan tranches, offset by $18.1M prior loan repayment. Investing yielded $6.1 million (vs. -$21.6 million used YoY) from $30.9M investment maturities net of $24.8M purchases. Net cash increase $8.2 million; ending cash, equivalents, restricted cash $24.8 million. Balance sheet: current assets $39.9 million (cash/equiv $20.9M, marketable $15.5M), total $41.8M; current liabilities $9.1M (incl. $3.7M current convertible debt, $1.6M contingent consideration), total liabilities $20.3M (non-current debt $11.2M), equity $21.5M with $281.6M APIC.
Management highlights liquidity of $36.4 million cash/securities but notes substantial going concern doubt, with resources insufficient for 12 months of operations. Additional capital needed via securities, debt, grants, or partnerships to fund cytisinicline commercialization post-NDA, manufacturing scale-up, and trials. Expenses expected to rise with regulatory pursuits, hiring, and launch prep. Risks include development uncertainty, capital market conditions, debt covenants (SVB New Convertible Term Loan $15M outstanding, matures 2028, convertible at $7+). No material off-balance sheet commitments beyond Sopharma contingent consideration. Strategic priorities: FDA approval, market entry; projects adjustable based on data/resources.