ACHIEVE LIFE SCIENCES, INC.
Business
ACHIEVE LIFE SCIENCES, INC. is a late-stage clinical specialty pharmaceutical company focused on developing and commercializing cytisinicline to treat nicotine dependence from combustible cigarettes and e-cigarettes. Its primary product candidate is cytisinicline, a naturally occurring alkaloid being evaluated in Phase 3 and open-label trials and supported by regulatory filings and safety studies. Business activities encompass clinical development, regulatory interactions, manufacturing supply arrangements and commercialization planning. The company pursues U.S. regulatory approval and commercialization outside Sopharma’s established Central and Eastern European territories through partner and direct distribution channels globally.
Summary from filing dated 2025-03-11
Financials
Consolidated Statement of Income
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Total operating expenses | 55 | 39 | 27 | 41 | 33 | |
| Interest income | 1 | 2 | 825,000 | 199,000 | 17,000 | |
| Interest expense [note 8] | −819,000 | −2 | −3 | −2 | — | |
| Change in fair value of contingent consideration [note 5 and note 6] | −408,000 | −621,000 | −528,000 | — | — | |
| Loss on extinguishment of 2023 SVB convertible term loan [note 8] | — | −283,000 | — | — | — | |
| Other income (expense) | −36,000 | −30,000 | −9,000 | 40,000 | −75,000 | |
| Total other income (expense) | 232,000 | −758,000 | −3 | −2 | −58,000 | |
| Net Loss | −55 | −40 | −30 | −42 | −33 | |
| Net unrealized gain (loss) on securities | −21,000 | 27,000 | — | — | — | |
| Total other comprehensive income (loss) | −21,000 | 27,000 | — | — | — | |
| Comprehensive loss | −55 | −40 | −30 | −42 | — | |
| Basic net loss per common share [note 10 [i]] | −1.25 | −1.24 | −1.5 | −4 | −4.08 | |
| Diluted net loss per common share [note 10 [i]] | −1.25 | −1.24 | −1.5 | −4 | −4.08 | |
| Shares used in computation of basic net loss per common share [note 10 [i]] | 44 | 32 | 20 | 11 | 8 | |
| Shares used in computation of Diluted net loss per common share [note 10 [i]] | 44 | 32 | 20 | 11 | 8 |
Consolidated Balance Sheet
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents [note 3 and note 6] | 21 | 13 | 16 | 25 | 43 | |
| Marketable securities [note 6] | 15 | 22 | — | — | — | |
| Total current assets | 40 | 36 | 17 | 27 | 45 | |
| Restricted cash and other assets [note 6 and note 7] | 52,000 | 39,000 | 92,000 | 66,000 | 183,000 | |
| Right-of-use assets [note 12] | 64,000 | 119,000 | 66,000 | 123,000 | 64,000 | |
| License agreement [note 4 and note 5] | 751,000 | 974,000 | 1 | 1 | 2 | |
| Goodwill | 1 | 1 | 1 | 1 | 1 | |
| Total assets | 42 | 39 | 19 | 30 | 48 | |
| Accrued clinical liabilities | 368,000 | 1 | 280,000 | 2 | 1 | |
| Accrued compensation | 2 | 3 | 2 | 2 | 2 | |
| Current contingent consideration [note 5 and note 6] | 2 | 0 | 528,000 | — | — | |
| Current portion of long-term obligations [note 12] | 61,000 | 55,000 | 63,000 | 58,000 | 69,000 | |
| Current portion of convertible debt [note 6 and note 8] | 4 | — | 17 | 16 | — | |
| Total current liabilities | 9 | 7 | 21 | 22 | 5 | |
| Non-current portion of convertible debt [note 6 and note 8] | 11 | 10 | — | — | 15 | |
| Non-current contingent consideration [note 5 and note 6] | 0 | 1 | — | — | — | |
| Long-term obligations [note 12] | 5,000 | 66,000 | 6,000 | 69,000 | 4,000 | |
| Total liabilities | 20 | 18 | 21 | 22 | 19 | |
| Commitments and contingencies [note 12] | — | — | — | — | — | |
| Common stock, $0.001 par value, 150,000,000 shares authorized, 53,233,988 and 34,685,072 issued and outstanding at December 31, 2025 and December 31, 2024, respectively. | 121,000 | 103,000 | 90,000 | 87,000 | 79,000 | |
| Additional paid-in capital | 282 | 226 | 164 | 144 | 122 | |
| Accumulated deficit | −260 | −206 | −166 | −136 | −94 | |
| Accumulated other comprehensive income | 10,000 | 31,000 | 4,000 | 4,000 | 4,000 | |
| Total stockholders' equity | 22 | 21 | −1 | 8 | 28 | |
| Total liabilities and stockholders' equity | 42 | 39 | 19 | 30 | 48 |
Consolidated Statement of Cash Flows
| Concept | Trend | FY 2025 2025-12-31 | FY 2024 2024-12-31 | FY 2023 2023-12-31 | FY 2022 2022-12-31 | FY 2021 2021-12-31 |
|---|---|---|---|---|---|---|
| Net loss | −55 | −40 | −30 | −42 | −33 | |
| Depreciation and amortization [note 4] | 228,000 | 229,000 | 228,000 | 236,000 | 250,000 | |
| Stock-based compensation [note 10[c], note 10[d], note 10[e]] and note 10[f]] | 9 | 5 | 3 | 3 | 2 | |
| Shares issued as settlement with trade vendor | 0 | — | 273,000 | 26,000 | 41,000 | |
| Accrued interest on SVB convertible debt [note 8] | 0 | 799,000 | 1 | 1 | — | |
| Amortization of 2024 SVB convertible term loan transaction costs [note 8] | 52,000 | 23,000 | — | — | — | |
| Accretion of discount on modification of debt [note 8] | — | 365,000 | 430,000 | — | — | |
| Grant receivable | — | 111,000 | −6,000 | 48,000 | −153,000 | |
| Accrued clinical liabilities | −709,000 | 797,000 | −1 | 376,000 | 899,000 | |
| Accrued compensation | −1 | 716,000 | 633,000 | −263,000 | 466,000 | |
| Lease obligation | 0 | −1,000 | −58,000 | −5,000 | −14,000 | |
| Net cash used in operating activities | −50 | −30 | −24 | −38 | −29 | |
| Proceeds from exercise of warrants [note 10[g]] | 1 | 682,000 | 227,000 | 24,000 | 338,000 | |
| Proceeds from employee stock purchase plan [note 10[e]] | 0 | 178,000 | — | 126,000 | — | |
| Taxes paid related to net share settlement of equity awards | 0 | −114,000 | −220,000 | −47,000 | — | |
| Proceeds from June 2025 public offering exercise of overallotment option, net of issuance costs [note 10b] | 4 | — | — | — | — | |
| Repayment of 2023 SVB convertible term loan [note 6 and note 8] | — | −18 | — | — | — | |
| Receipt of 2024 SVB convertible term loan less transaction costs [note 6 and note 8] | — | 10 | — | — | 15 | |
| Receipt of 2024 SVB convertible term loan second tranche [note 6 and note 8] | 5 | — | — | — | — | |
| Net cash provided by financing activities | 52 | 49 | 15 | 19 | 37 | |
| Purchase of property and equipment | −3,000 | — | −21,000 | — | — | |
| Loss on disposal of property and equipment | −1,000 | — | — | — | — | |
| Realized gain on investments | 4,000 | — | — | — | — | |
| Purchase of investments | −25 | −48 | — | — | — | |
| Maturities of investments | 31 | 26 | — | — | — | |
| Net cash provided by (used in) investing activities | 6 | −22 | −21,000 | — | — | |
| Effect of exchange rate changes on cash | 3,000 | — | −3,000 | 3,000 | −1,000 | |
| Net increase (decrease) in cash, cash equivalents and restricted cash | 8 | −3 | −9 | −18 | 7 |