Trevi Therapeutics ((TRVI)) has held its Q4 earnings call. Read on for the main highlights of the call.
Trevi Therapeutics’ recent earnings call presented a mixed sentiment, highlighting significant clinical successes alongside financial challenges. While the company showcased promising clinical outcomes, increased losses and expenses pose hurdles. Nevertheless, the positive clinical data suggests a hopeful future for Trevi Therapeutics.
Positive Data Readouts
Trevi Therapeutics reported three positive data readouts in 2024, marking substantial clinical progress for their lead drug, Haduvio. Notably, the Human Abuse Potential study, the Sample Size Re-Estimation, and the RIVER study demonstrated strong results, reinforcing confidence in the drug’s development.
Successful Human Abuse Potential Study
The Human Abuse Potential study yielded statistically significant findings, showing lower relative drug liking for nalbuphine compared to butorphanol. This outcome supports the continued unscheduled status of nalbuphine by the DEA, bolstering its clinical credibility.
RIVER Study Success
In the RIVER study, Trevi achieved a significant milestone with a 57% placebo-adjusted reduction in 24-hour objective cough frequency among RCC patients. This success underscores the potential of Haduvio in addressing refractory chronic cough.
Financial Stability
Trevi’s financial position remains robust, having completed a $50 million unwritten offering. With cash, cash equivalents, and marketable securities totaling $107.6 million, the company is well-positioned financially, with a cash runway extending into the second half of 2026.
Increased Net Loss
Despite clinical advancements, Trevi reported an increased net loss of $11.4 million for Q4 2024, up from $7.8 million in Q4 2023. This rise is primarily attributed to heightened R&D expenses, reflecting the company’s investment in clinical trials.
Higher R&D Expenses
R&D expenses surged to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, driven by costs associated with clinical trials and personnel expenses. This increase highlights Trevi’s commitment to advancing its drug development pipeline.
Higher G&A Expenses
General and administrative expenses also rose to $2.9 million in Q4 2024 from $2.4 million in the previous year. This increase is linked to higher stock-based compensation and personnel expenses, reflecting the company’s growth trajectory.
Forward-Looking Guidance
Looking ahead, Trevi Therapeutics provided detailed guidance on its future plans for Haduvio. The company anticipates a Phase 2b readout for the CORAL trial in Q2 2025 and plans for an End-of-Phase 2 meeting with the FDA by the end of 2025. With a cash runway into the second half of 2026, Trevi is preparing for the next RCC trial while continuing to develop Haduvio for IPF and RCC.
In conclusion, Trevi Therapeutics’ earnings call painted a picture of clinical optimism tempered by financial challenges. The company’s significant clinical achievements, particularly with Haduvio, present a promising outlook despite increased expenses and net losses. Investors and stakeholders will be keenly watching Trevi’s progress in the coming quarters.