Trevi Therapeutics, Inc. — 2023 Form 10-K
Reporting period: Fiscal year ended December 31, 2023; filed March 20, 2024. This is an annual report, not a standalone fourth-quarter report, and the filing does not provide a clear Q4-only financial comparison. Trevi is a clinical-stage biopharmaceutical company with no approved products or product sales. Its lead candidate is Haduvio, an oral extended-release formulation of nalbuphine.
Financial results and liquidity
| Metric | 2023 | 2022 | Change / context |
|---|---|---|---|
| Revenue | $0 | $0 | No product revenue; margins are not meaningful. |
| Research and development expense | $23.7 million | $19.8 million | Up $3.8 million, or 19.4%, mainly as CORAL and RIVER trials began. |
| General and administrative expense | $10.2 million | $10.1 million | Up $0.1 million, or 1.7%. |
| Total operating expenses | $33.9 million | $29.9 million | Up $4.0 million. |
| Net loss | $29.1 million | $29.2 million | Nearly unchanged; higher interest income largely offset increased operating expenses. |
| Net loss per share, basic and diluted | $0.29 | $0.45 | Per-share loss narrowed; weighted-average shares increased substantially. |
| Cash, cash equivalents and marketable securities | $83.0 million | $120.5 million | Down $37.5 million. |
| Net cash used in operating activities | $31.7 million | $28.2 million | Operating cash use increased $3.5 million. |
| Debt | $0 outstanding | $8.2 million outstanding | SVB term loan fully repaid in May 2023; payoff was $6.5 million. |
At year-end, Trevi reported total assets of $89.4 million, total liabilities of $6.9 million and stockholders’ equity of $82.5 million. Interest income was $4.7 million, versus $1.7 million in 2022. The company reported an accumulated deficit of $239.1 million.
Business progress and material changes
- IPF chronic cough: Trevi started the Phase 2b CORAL dose-ranging trial in December 2023, planned for approximately 160 patients. The primary endpoint is change in 24-hour cough frequency. A sample-size re-estimation was expected in the second half of 2024; topline results were expected in the first half of 2025, assuming no sample-size adjustment. A Phase 1b respiratory-physiology study was planned for 2024, subject to regulatory agreement and an active IND.
- Refractory chronic cough (RCC): The Phase 2a RIVER trial began in November 2023 and was designed to enroll approximately 60 patients in the U.K. and Canada. Topline data were expected in the second half of 2024.
- Human abuse potential: The FDA agreed with the selected comparator dose for the second part of the HAP study. Dosing began in January 2024; the company reported the study was more than 50% enrolled as of March 11, 2024, with topline data expected in the second half of 2024.
- Prurigo nodularis: Trevi reported positive Phase 2b/3 PRISM results in 2022 and preliminary open-label extension findings in 2023. It expects an additional Phase 3 trial will be needed for an application and planned to seek an end-of-Phase-2 meeting with the FDA; further development decisions were pending regulatory discussions. The company may seek a strategic partner for this program.
In the earlier CANAL Phase 2 IPF trial, Haduvio reduced daytime cough frequency by 75.1% from baseline versus 22.6% for placebo, a 52.5% placebo-adjusted difference (p<0.0001). These Phase 2 findings do not establish later-stage success. In PRISM, 25% of Haduvio patients versus 14% of placebo patients met the primary itch-response endpoint at week 14 (p=0.0157). In its 38-week open-label extension, 151 patients completed treatment; 13% discontinued due to adverse events, and 13 patients had serious adverse events, two considered potentially treatment-related.
Outlook, risks and unusual items
- Runway and funding: Management stated in its MD&A that year-end cash and investments were expected to fund operations into 2026. The financial-statement note, dated March 20, 2024, states the funds were sufficient for 12 months from issuance. These statements differ in stated runway. Trevi also says existing resources will not fund full development across its indications and it has no committed external funding source; additional financing may be required.
- Clinical and regulatory risk: Haduvio is the company’s sole product candidate, remains investigational and has not generated revenue. Trial outcomes, enrollment, safety findings, regulatory requirements and timelines are uncertain. The planned IPF respiratory study is intended to assess safety in patients with varying disease severity.
- Safety and potential controls: Nalbuphine carries an opioid-class warning for serious respiratory depression. The filing identifies potential opioid-related risks, including sedation, psychiatric effects, withdrawal and possible abuse-related restrictions. FDA requirements or DEA controlled-substance scheduling could constrain use, distribution or commercialization.
- Supply and execution: Trevi relies on third parties for trials and manufacturing, including a single active-ingredient supplier, Mallinckrodt. The supplier emerged from bankruptcy in November 2023; the effect on future supply was uncertain. The company has no formal commercial-scale supply agreements.
- Share dilution: At December 31, 2023, 40.9 million shares were reserved for outstanding warrants and pre-funded warrants, compared with 68.3 million common shares outstanding. Further equity financing and warrant exercises could dilute existing holders. The company also had a $200 million shelf registration and a $75 million ATM program; no sales under the new ATM had occurred by year-end.
- Other items: Trevi reported no material legal proceedings. Management concluded disclosure controls and internal control over financial reporting were effective as of year-end. The independent auditor issued an unqualified opinion on the financial statements; it did not attest to internal control effectiveness, consistent with the company’s exemption.
Important facts for investors to verify
- Reconcile the stated cash runway: “into 2026” in MD&A versus “12 months from issuance” in the financial-statement note.
- Check CORAL sample-size re-estimation, enrollment and eventual topline results, and whether the planned Phase 1b IPF safety study proceeded.
- Review RIVER and HAP results, including safety findings and any resulting FDA or DEA requirements.
- Track the FDA’s required evidence and Trevi’s financing or partnering plans for a possible additional prurigo nodularis Phase 3 trial.
- Assess cash burn, available financing capacity, warrant overhang and share-count changes; year-end common shares were 68.3 million and 68.96 million were reported outstanding as of March 20, 2024.