Trevi Therapeutics Inc (TRVI) Q4 2024 Earnings Call Highlights: Navigating Losses and Advancing ...
R&D Expenses: $9.3 million in Q4 2024, up from $6.5 million in Q4 2023.
G&A Expenses: $2.9 million in Q4 2024, compared to $2.4 million in Q4 2023.
Cash, Cash Equivalents, and Marketable Securities: $107.6 million as of December 31, 2024.
Cash Burn Guidance: Expected $12 million to $14 million per quarter in Q1 and Q2 2025.
Fully Diluted Shares Outstanding: Approximately 137 million, including 10 million stock options.
Warning! GuruFocus has detected 4 Warning Signs with TRVI.
Release Date: March 18, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Trevi Therapeutics Inc (NASDAQ:TRVI) reported three positive data readouts in 2024, including the Human Abuse Potential study, the CORAL study in chronic cough patients with IPF, and the RIVER study in patients with refractory chronic cough.
The company successfully conducted trials across 11 countries and approximately 75 different sites, demonstrating strong execution and commitment to high-quality trials.
The Human Abuse Potential study showed statistically significant lower relative drug liking for nalbuphine doses compared to butorphanol, supporting its safety profile.
The Phase 2a RIVER trial met its primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, showing promise for Haduvio in treating RCC.
Trevi Therapeutics Inc (NASDAQ:TRVI) has a strong cash position with $107.6 million in cash, cash equivalents, and marketable securities, providing a cash runway into the second half of 2026.
Trevi Therapeutics Inc (NASDAQ:TRVI) reported a net loss of $11.4 million for the fourth quarter of 2024, an increase from the $7.8 million loss in the same quarter of 2023.
Research and development expenses increased significantly to $9.3 million during the fourth quarter of 2024, primarily due to increased clinical trial costs.
General and administrative expenses also rose to $2.9 million during the fourth quarter of 2024, driven by increased stock-based compensation and personnel-related expenses.
The company faces uncertainty regarding the final determination of nalbuphine's scheduling status, which will be made upon FDA and DEA approval.
Trevi Therapeutics Inc (NASDAQ:TRVI) needs to conduct further studies and regulatory discussions to advance Haduvio's development, which may impact timelines and require additional resources.
Q: Could you speak about the patients enrolled in the CORAL study and any differences observed in the first and second halves of the study? A: Jennifer Good, President and CEO, explained that no changes were made to the study as it was already 75-80% enrolled by December. The study statistics remained consistent, and no changes were communicated to the sites to ensure consistency in the study protocol.
Q: Can you comment on the discontinuation rate in the CORAL study? A: Jennifer Good confirmed that the discontinuation rate remained in single digits throughout the study, indicating consistency and stability in the patient population.
Q: What are your expectations for the placebo response in the IPF chronic cough Phase 2 study? A: Jennifer Good stated that placebo hasn't been a significant issue in IPF studies. The study assumed a 66% drug effect and a 30% placebo effect, with the SSRE confirming these assumptions. Placebo effects in prior IPF cough studies have ranged from 15% to 23%.
Q: How do you see the RCC patient population being split between P2X3 and Haduvio if both are on the market? A: Jennifer Good mentioned that Haduvio would target patients who have failed prior therapies, potentially serving as a second or third-line treatment. The unmet need remains high, especially since P2X3 antagonists have shown efficacy primarily in severe coughers.
Q: Regarding the RIVER RCC data, are there any plans to adjust dosing in future studies? A: Jennifer Good noted that the effective dose appears to be in the 27 to 54 mg range, and the 108 mg dose may not be necessary. This allows for more flexibility in dosing and potentially reduces adverse effects.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
This article first appeared on GuruFocus.
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