Trevi Therapeutics, Inc.
Business
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing Haduvio (oral nalbuphine ER) to treat chronic cough in patients with idiopathic pulmonary fibrosis, non‑IPF interstitial lung disease and refractory chronic cough. Haduvio is an oral extended‑release nalbuphine formulation that acts as a kappa‑opioid receptor agonist and mu‑opioid receptor antagonist to modulate the cough reflex. Key programs include clinical development in IPF, non‑IPF ILD and RCC, plus human abuse potential and hepatic impairment studies. The company conducts trials in the U.S., U.K. and Canada, retains worldwide commercial rights, and relies on third‑party manufacturers and ex‑U.S. collaborators for distribution.
Summary from filing dated 2025-03-18
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 |
|---|---|---|---|---|---|---|
| Research and development | 33 | 39 | 24 | 20 | 23 | |
| General and administrative | 16 | 12 | 10 | 10 | 9 | |
| Total operating expenses | 49 | 52 | 34 | 30 | 32 | |
| Loss from operations | −49 | −52 | −34 | −30 | −32 | |
| Interest income, net | 7 | 4 | 5 | — | — | |
| Other expense, net | −31,000 | −15,000 | 469,000 | 289,000 | −375,000 | |
| Interest expense | 0 | −4,000 | −391,000 | — | — | |
| Total other income, net | 7 | 4 | 5 | 719,000 | −1 | |
| Loss before income taxes | −43 | −48 | −29 | −29 | −34 | |
| Income tax benefit | −64,000 | −30,000 | 32,000 | 36,000 | 21,000 | |
| Net loss | −43 | −48 | −29 | −29 | −34 | |
| Basic net loss per common share outstanding | −0.32 | −0.47 | −0.29 | −0.45 | −1.49 | |
| Diluted net loss per common share outstanding | −0.32 | −0.47 | −0.29 | −0.45 | −1.49 | |
| Weighted average common shares used in net loss per share attributable to common stockholders, basic | 135 | 102 | 99 | 65 | 23 | |
| Weighted average common shares used in net loss per share attributable to common stockholders, diluted | 135 | 102 | 99 | 65 | 23 | |
| Net unrealized gains on available-for-sale marketable securities | 87,000 | 90,000 | 93,000 | −122,000 | — | |
| Comprehensive loss | −43 | −48 | −29 | −29 | −34 |
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 | 19 | 34 | 32 | 13 | 37 | |
| Marketable securities | 169 | 74 | 51 | 108 | — | |
| Prepaid expenses | 1 | 939,000 | 4 | 795,000 | 886,000 | |
| Other current assets | 2 | 867,000 | 955,000 | 1 | 241,000 | |
| Total current assets | 192 | 109 | 88 | 123 | 38 | |
| Operating lease right-of-use assets | 677,000 | 915,000 | 1 | 24,000 | 131,000 | |
| Property, equipment and leasehold improvements, net | 178,000 | 157,000 | 216,000 | 170,000 | 53,000 | |
| Other non-current assets | 928,000 | 243,000 | 297,000 | 205,000 | 334,000 | |
| Finance lease right-of-use assets | 0 | 157,000 | 206,000 | — | — | |
| Total assets | 193 | 111 | 89 | 123 | 38 | |
| Accounts payable | 4 | 3 | 2 | 3 | 3 | |
| Accrued expenses | 6 | 7 | 4 | 4 | 4 | |
| Operating lease liabilities | 307,000 | 254,000 | 184,000 | 25,000 | 120,000 | |
| Finance lease liabilities | 0 | 31,000 | 122,000 | — | — | |
| Total current liabilities | 10 | 11 | 6 | 13 | 13 | |
| Operating lease liabilities | 446,000 | 747,000 | 1 | 2,000 | 24,000 | |
| Total liabilities | 10 | 11 | 7 | 16 | 21 | |
| Commitments and contingencies (Note 13) | — | — | — | — | — | |
| Preferred stock: $0.001 par value; 5,000,000 shares authorized at December 31, 2025 and December 31, 2024; no shares issued or outstanding at December 31, 2025 and December 31, 2024.Preferred stock: $0.001 par value; 5,000,000 shares authorized at December 31, 2025 and December 31, 2024; no shares issued or outstanding at December 31, 2025 and December 31, 2024. | — | — | — | — | — | |
| Common stock: $0.001 par value; 200,000,000 shares authorized at December 31, 2025 and December 31, 2024; and 128,306,056 and 93,602,631 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively. | 128,000 | 94,000 | 68,000 | 60,000 | 29,000 | |
| Additional paid-in capital | 513 | 387 | 322 | 318 | 198 | |
| Accumulated other comprehensive income | 148,000 | 61,000 | −29,000 | −122,000 | — | |
| Accumulated deficit | −330 | −287 | −239 | −210 | −181 | |
| Total stockholders equity | 183 | 100 | 83 | 107 | 17 | |
| Total liabilities and stockholders equity | 193 | 111 | 89 | 123 | 38 |
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 |
|---|---|---|---|---|---|---|
| Stock-based compensation | 5 | 4 | 2 | 2 | 3 | |
| Operating lease right-of-use assets | 437,000 | 460,000 | 377,000 | 0 | — | |
| Depreciation and amortization | 144,000 | 147,000 | 123,000 | 43,000 | — | |
| Accretion of available-for-sale marketable securities, net | −2 | −1 | −2 | −829,000 | — | |
| Write off of deferred offering costs | 26,000 | — | 390,000 | — | — | |
| Loss on disposal of property, equipment and leasehold improvements | 7,000 | — | 10,000 | — | — | |
| Prepaid expenses and other current assets | −1 | 3 | −3 | −601,000 | 342,000 | |
| Accrued expenses and other liabilities | −1 | 3 | 52,000 | −639,000 | 336,000 | |
| Accounts payable | −598,000 | 2 | −1 | 9,000 | 831,000 | |
| Net cash used in operating activities | −42 | −38 | −32 | −28 | −29 | |
| Proceeds from maturities of available-for-sale marketable securities | 77 | 77 | 69 | 19 | — | |
| Purchases of available-for-sale marketable securities | −171 | −98 | −10 | −126 | — | |
| Purchases of property, equipment and leasehold improvements | −12,000 | −35,000 | −137,000 | −159,000 | — | |
| Net cash used in investing activities | −94 | −22 | 59 | −107 | — | |
| Proceeds from offering, net of commissions | 108 | 47 | — | — | — | |
| Proceeds from exercises of warrants | 11 | — | — | 12 | 3,000 | |
| Proceeds from exercises of stock options | 2 | 394,000 | 74,000 | 139,000 | — | |
| Proceeds from disgorgement of beneficial owner's short-swing profits | 725,000 | — | — | — | — | |
| Proceeds from employee stock purchase plan | 118,000 | 70,000 | 68,000 | 56,000 | 39,000 | |
| Payments of offering costs | −809,000 | — | −258,000 | −226,000 | −382,000 | |
| Payments of finance lease | −11,000 | −126,000 | −95,000 | — | — | |
| Proceeds from at-the-market sales, net of commissions | — | 14 | 2 | — | 8 | |
| Net cash provided by financing activities | 121 | 61 | −8 | 111 | 21 | |
| Net (decrease) increase in cash and cash equivalents | −15 | 2 | 20 | −24 | −8 | |
| Interest paid | — | −4,000 | −331,000 | −594,000 | 603,000 | |
| State research tax credits exchanged for cash | 33,000 | 32,000 | 55,000 | — | 18,000 | |
| Offering costs included in accrued expenses | — | 233,000 | — | 15,000 | 41,000 |