Trevi Therapeutics, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024; unaudited. Trevi is a clinical-stage biopharmaceutical company developing Haduvio (oral extended-release nalbuphine), its sole product candidate. It has no approved products and has not generated product revenue.
Financial performance and liquidity
| Metric | Q1 2024 | Q1 2023 / comparison |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $8.8 million | $5.0 million; up $3.8 million |
| General and administrative expense | $3.1 million | $2.6 million; up $0.5 million |
| Total operating expenses | $11.9 million | $7.6 million; up $4.3 million |
| Net loss | $10.9 million | $6.4 million |
| Net loss per share | $0.11 | $0.06 |
| Cash used in operating activities | $10.5 million | $8.2 million |
| Cash, cash equivalents and marketable securities | $72.8 million at March 31 | $83.0 million at December 31, 2023 |
Margins are not meaningful because the company has no product revenue. Higher R&D expense primarily reflected activity in the CORAL and RIVER trials and the human abuse potential study; lower PRISM extension-trial activity partly offset the increase. G&A rose mainly with finance and IT staffing and professional fees. Interest income declined as investment balances fell; Q1 2023 also included a CARES Act tax credit. The prior-year period included $0.2 million of term-loan interest expense.
At March 31, 2024, total assets were $78.6 million, total liabilities $6.2 million and stockholders’ equity $72.3 million. Trevi reported no outstanding debt; the SVB term loan was fully repaid in May 2023. Q1 investing cash outflow was $8.1 million, largely reflecting purchases of marketable securities net of maturities. Cash and cash equivalents alone were $13.8 million at quarter-end.
Material developments, outlook and risks
- Management said existing cash, cash equivalents and marketable securities were expected to fund operating expenses and capital requirements into 2026. This estimate excludes potential additional prurigo nodularis trials and depends on assumptions; the company says it will need substantial additional funding and has no committed external funding source.
- CORAL, a Phase 2b dose-ranging trial for chronic cough in IPF, began in December 2023. The sample-size re-estimation is expected in the second half of 2024; topline results are expected in the first half of 2025, assuming no sample-size adjustment.
- RIVER, a Phase 2a trial for refractory chronic cough, began in November 2023; topline data are expected in the second half of 2024. The HAP study was 75% enrolled, with topline data also expected in the second half of 2024. A Phase 1b respiratory-physiology study in IPF patients is expected to begin in Q3 2024.
- Following positive Phase 2b/3 PRISM results in prurigo nodularis, Trevi expects to discuss next steps with regulators, including a potential additional Phase 3 trial, and may seek a strategic collaborator. Its current runway estimate does not include costs of additional trials in this indication.
- After quarter-end through May 7, Trevi sold 1,474,926 shares under its ATM agreement for gross proceeds of $5.0 million, before approximately $0.2 million of commissions and allocated fees. Shares outstanding were 70,435,093 on May 7, versus 68,960,167 at March 31.
- Key risks include clinical-trial failure or delay, enrollment and funding needs, opioid-associated respiratory depression and potential misuse or controlled-substance restrictions, and reliance on third parties. Mallinckrodt is the sole nalbuphine drug-substance supplier; it emerged from bankruptcy in November 2023, and Trevi has not qualified an alternate source. No material legal proceedings were reported. Management assessed disclosure controls as effective.
Important facts for investors to verify
- Whether CORAL and RIVER enrollment, trial timing and projected data releases remain on plan, and whether CORAL’s sample-size re-estimation changes its scope or cost.
- Whether the stated cash runway into 2026 remains supportable as trial spending increases, particularly if additional prurigo nodularis studies are pursued.
- ATM sales and resulting share dilution, alongside the substantial warrant overhang: 40.3 million warrant shares were outstanding at March 31, including 30.6 million pre-funded warrant shares.
- Progress on qualifying an alternate nalbuphine supplier and any supply or cost implications from Mallinckrodt’s restructuring.
- Potential Haduvio safety, abuse-potential, REMS or controlled-substance requirements and their impact on development, labeling and commercialization.