Clene Inc.
Business
Clene Inc. is a clinical-stage pharmaceutical company that develops proprietary clean-surfaced nanotechnology (CSN®) therapeutics to catalytically support cellular energetic and metabolic reactions in diseased cells. Its main products include investigational nanocrystal drug candidates such as CNM-Au8 for neurodegenerative diseases, ionic zinc–silver and silver–zinc formulations (CNM‑ZnAg, CNM‑AgZn17), and low‑concentration dietary supplement formulations marketed via subsidiary dOrbital and a license with 4Life. The company operates R&D, nonclinical and clinical development teams, GMP manufacturing facilities, and clinical operations including EAPs and registrational trials. It conducts clinical trials and distributes supplements through international partners and clinical networks across the U.S., Australia, Brazil and other markets.
Summary from filing dated 2025-03-24
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 revenue | 200,000 | 342,000 | 654,000 | 473,000 | 723,000 | |
| Cost of revenue | 43,000 | 70,000 | 121,000 | 26,000 | 289,000 | |
| Research and development | 14 | 20 | 27 | 32 | 28 | |
| General and administrative | 9 | 13 | 14 | 17 | 22 | |
| Total operating expenses | 23 | 33 | 41 | 49 | 51 | |
| Loss from operations | −23 | −33 | −41 | −48 | −50 | |
| Interest income | 223,000 | 865,000 | 1 | 225,000 | — | |
| Interest expense | −3 | −4 | −5 | — | — | |
| Loss on extinguishment of notes payable | 0 | −214,000 | 0 | — | — | |
| Issuance costs for common stock warrant liabilities | 0 | −157,000 | −333,000 | 0 | — | |
| Loss on initial issuance of equity | 0 | −2 | −15 | 0 | — | |
| Change in fair value of common stock warrant liabilities | −522,000 | −702,000 | 6 | 169,000 | — | |
| Change in fair value of derivative liabilities | −363,000 | −379,000 | 0 | 169,000 | 983,000 | |
| Change in fair value of Clene Nanomedicine contingent earn-out liability | 0 | 75,000 | 2 | 16 | 34 | |
| Change in fair value of Initial Stockholders contingent earn-out liability | 0 | 10,000 | 281,000 | 2 | 4 | |
| Research and development tax credits and unrestricted grants | 254,000 | 357,000 | 963,000 | 3 | 2 | |
| Other expense, net | 0 | −1,000 | 10,000 | 32,000 | −12,000 | |
| Total other income (expense), net | −3 | −6 | −9 | 18 | 40 | |
| Net loss before income taxes | −26 | −39 | −50 | −30 | −10 | |
| Income tax expense | 0 | 0 | 0 | 0 | 428,000 | |
| Net loss | −26 | −39 | −50 | −30 | −10 | |
| Unrealized loss on available-for-sale securities | 0 | −1,000 | — | — | — | |
| Foreign currency translation adjustments | 101,000 | −127,000 | −20,000 | −16,000 | −92,000 | |
| Total other comprehensive income (loss) | 101,000 | −128,000 | −4,000 | −30,000 | −92,000 | |
| Comprehensive loss | −26 | −40 | −50 | −30 | −10 | |
| Net loss per share basic and diluted (in dollars per share) | −2.65 | −5.67 | −9.43 | −0.46 | −0.16 | |
| Weighted average common shares used to compute basic and diluted net loss per share (in shares) | 10 | 7 | 5 | 65 | 62 |
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 2022 2022-02-28 |
|---|---|---|---|---|---|---|
| Cash and cash equivalents | 5 | 12 | 29 | 18 | — | |
| Accounts receivable | 0 | 64,000 | 143,000 | 189,000 | — | |
| Inventory | 37,000 | 68,000 | 37,000 | 43,000 | — | |
| Prepaid expenses and other current assets | 4 | 4 | 4 | 6 | — | |
| Total current assets | 9 | 16 | 39 | 29 | — | |
| Restricted cash | 58,000 | 58,000 | 58,000 | 58,000 | — | |
| Operating lease right-of-use assets | 3 | 4 | 4 | 5 | 2 | |
| Property and equipment, net | 6 | 7 | 9 | 11 | — | |
| TOTAL ASSETS | 18 | 27 | 52 | 44 | — | |
| Accounts payable | 892,000 | 1 | 2 | 3 | — | |
| Accrued liabilities | 5 | 8 | 4 | 4 | — | |
| Operating lease obligations, current portion | 808,000 | 926,000 | 576,000 | 488,000 | — | |
| Notes payable, current portion | 2 | 359,000 | — | — | — | |
| Convertible notes payable, current portion | 2 | 0 | — | — | — | |
| Total current liabilities | 11 | 10 | 25 | 14 | — | |
| Operating lease obligations, net of current portion | 3 | 4 | 5 | 6 | — | |
| Notes payable, net of current portion | 4 | 5 | 2 | 9 | — | |
| Convertible notes payable | 10 | 11 | 5 | 10 | — | |
| TOTAL LIABILITIES | 36 | 36 | 39 | 41 | — | |
| Commitments and contingencies (Note 9) | — | — | — | — | — | |
| Common stock, $0.0001 par value: 600,000,000 shares authorized; 10,849,974 and 8,089,565 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | 1,000 | 1,000 | 1,000 | 7,000 | — | |
| Additional paid-in capital | 291 | 273 | 256 | 196 | — | |
| Accumulated deficit | −308 | −282 | −243 | −193 | — | |
| Accumulated other comprehensive income | 172,000 | 71,000 | 199,000 | 203,000 | — | |
| TOTAL STOCKHOLDERS DEFICIT | −18 | −9 | 13 | 3 | — | |
| TOTAL LIABILITIES AND STOCKHOLDERS DEFICIT | 18 | 27 | 52 | 44 | — |
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 |
|---|---|---|---|---|---|---|
| Depreciation | 1 | 2 | 2 | 1 | 955,000 | |
| Non-cash lease expense | 571,000 | 524,000 | 434,000 | 389,000 | 171,000 | |
| Issuance of common stock as payment of outstanding indebtedness | 8,000 | 0 | — | — | — | |
| Stock-based compensation expense | 6 | 8 | 9 | 9 | 12 | |
| Loss on disposal of property and equipment | 0 | 154,000 | 0 | — | — | |
| Accretion of debt discount | 1 | 1 | 1 | 863,000 | 336,000 | |
| Non-cash interest income on marketable securities | 0 | −153,000 | 0 | — | — | |
| Non-cash interest expense on notes payable | 612,000 | 136,000 | 350,000 | — | — | |
| Accounts receivable | 64,000 | 79,000 | 46,000 | −140,000 | −28,000 | |
| Inventory | 31,000 | −31,000 | 6,000 | −2,000 | 150,000 | |
| Prepaid expenses and other current assets | 119,000 | −198,000 | 2 | −1 | −702,000 | |
| Accounts payable | −348,000 | −264,000 | −2 | 285,000 | 1 | |
| Accrued liabilities | −2 | 4 | −143,000 | 253,000 | 894,000 | |
| Operating lease obligations | −1 | −421,000 | −566,000 | −493,000 | −154,000 | |
| Net cash used in operating activities | −19 | −21 | −30 | −39 | −35 | |
| Purchases of marketable securities | 0 | −6 | −6 | −25 | 0 | |
| Proceeds from maturities of marketable securities | 0 | 13 | 5 | 12 | 0 | |
| Purchases of property and equipment | −39,000 | −15,000 | −330,000 | −5 | −1 | |
| Net cash provided by (used in) investing activities | −39,000 | 6 | −1 | −10 | −1 | |
| Proceeds from exercise of stock options | 0 | 124,000 | 0 | 310,000 | 443,000 | |
| Proceeds from issuance of common stock, warrants, and pre-funded warrants, net of offering costs | 10 | 9 | 42 | 11 | — | |
| Proceeds from the issuance of debt and derivative liabilities | 2 | 10 | 350,000 | — | — | |
| Payments of notes payable | −384,000 | −21 | 0 | 0 | −5,000 | |
| Payments of finance lease obligations | 0 | −27,000 | −81,000 | −135,000 | −152,000 | |
| Net cash provided by (used in) financing activities | 12 | −2 | 42 | 17 | 27 | |
| Net decrease in cash, cash equivalents and restricted cash | −7 | −17 | 10 | −32 | −9 | |
| Effect of foreign exchange rate changes on cash and restricted cash | 101,000 | −127,000 | −4,000 | −30,000 | −85,000 | |
| Derivative liability recorded upon debt modification | 687,000 | 67,000 | — | — | — | |
| Derivative liability recorded upon debt issuance | 239,000 | 0 | — | — | — | |
| Common stock warrant liability recorded upon public stock offering | 0 | 2 | 7 | 0 | — | |
| Cash paid for interest expense | 1 | 3 | 3 | 2 | — |