Trevi Therapeutics (TRVI) Q2 2024 earnings summary

Executive summary

• Focused on developing Haduvio (oral nalbuphine ER) for chronic cough in IPF, RCC, and prurigo nodularis, with multiple clinical trials ongoing including Phase 2b CORAL (IPF), Phase 2a RIVER (RCC), and a human abuse potential (HAP) study.

• Maintains IPF as the lead indication, with RCC as a significant secondary opportunity; strong clinical trial recruitment with RIVER 80% enrolled and CORAL progressing.

• Hired Dr. Meg Garin as VP of Clinical Development to oversee the RIVER trial and enhance clinical operations.

• Ended Q2 2024 with $69.5M in cash, cash equivalents, and marketable securities, providing runway into 2026.

• Accumulated deficit reached $262.4 million as of June 30, 2024; no revenue generated from product sales.

Financial highlights

• Q2 2024 net loss was $12.4 million, up from $7.1 million in Q2 2023; net loss for the first half of 2024 was $23.3 million.

• R&D expenses rose to $10 million in Q2 2024 from $5.8 million year-over-year, and to $18.8 million for the first half of 2024.

• G&A expenses increased to $3.3 million in Q2 2024 from $2.5 million, and to $6.4 million for the first half of 2024.

• Cash, cash equivalents, and marketable securities totaled $69.5 million as of June 30, 2024.

• Issued 1.5 million shares via ATM, purchased by a single buyer, raising $5.0 million in the first half of 2024.

Outlook and guidance

• Expects RIVER trial data in RCC and HAP study topline data in Q4 2024; CORAL IPF trial top-line data anticipated in H1 2025.

• Cash runway projected into 2026, with cash burn expected at $9–12 million per quarter for 2024.

• No expected delays in RIVER trial readout; minor enrollment imbalances may extend study by 1–2 months if needed.

• Substantial additional funding will be needed to complete development and commercialization of Haduvio.