Trevi Therapeutics Inc (TRVI) Announces Year-End Financials and Progress in Clinical Trials

Key Trials Advance as Company Eyes Milestone Data Readouts in 2024

Summary
  • Financial Position: Ended 2023 with $83.0 million in cash, cash equivalents, and marketable securities.
  • Research and Development Expenses: Increased to $23.7 million in 2023 from $19.8 million in 2022.
  • General and Administrative Expenses: Remained stable at $10.2 million in 2023 compared to $10.1 million in 2022.
  • Net Loss: Reported a net loss of $29.1 million for the year ended December 31, 2023, consistent with the previous year's net loss of $29.2 million.
  • Clinical Trial Progress: Advancements in Phase 2a RIVER and Phase 2b CORAL trials, with topline data expected in the second half of 2024 and first half of 2025, respectively.
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On March 20, 2024, Trevi Therapeutics Inc (TRVI, Financial) released its 8-K filing, disclosing its fourth quarter and full-year financial results for 2023, along with updates on its business operations. The clinical-stage biopharmaceutical company, known for developing Haduvio (oral nalbuphine ER) for various chronic cough conditions and prurigo nodularis, is moving forward with its clinical trials and expects significant data readouts in the coming year.

Financial Overview and Clinical Advancements

Trevi Therapeutics Inc (TRVI, Financial) reported an increase in research and development expenses to $6.5 million in the fourth quarter of 2023, up from $4.3 million in the same period in 2022. This rise is attributed to the initiation of the Phase 2b CORAL trial and the Phase 2a RIVER trial. General and administrative expenses saw a slight uptick to $2.4 million in the fourth quarter, compared to $2.3 million in the previous year. The company's net loss widened to $7.8 million in the fourth quarter of 2023 from $5.5 million in the same quarter of 2022.

For the full year, research and development expenses were $23.7 million, an increase from $19.8 million in 2022, driven by the costs associated with the new trials and increased consultant services and personnel-related expenses. General and administrative expenses remained relatively flat year-over-year. The net loss for the year was marginally reduced to $29.1 million from $29.2 million in 2022.

Despite the net loss, the company's financial position remains strong, with $83.0 million in cash, cash equivalents, and marketable securities, providing a cash runway into 2026. This robust financial standing is crucial for Trevi Therapeutics Inc (TRVI, Financial) as it continues to invest in its clinical programs and moves closer to potential commercialization of its products.

Strategic Clinical Trials and Future Outlook

The Phase 2a RIVER trial for refractory chronic cough (RCC) and the Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF) patients are progressing, with topline data expected in the second half of 2024 and the first half of 2025, respectively. The Human Abuse Potential (HAP) study is also more than 50% enrolled, with topline data anticipated in the second half of 2024.

The company's President and CEO, Jennifer Good, expressed confidence in the progress made in 2023 and the potential for 2024 to be a milestone year with important data readouts.

We are expecting 2024 to be a milestone year of important data readouts in areas of chronic cough where there is a significant unmet need with no approved treatments in the United States,"
said Good.

The advancement of these trials is critical for Trevi Therapeutics Inc (TRVI, Financial), as the company aims to address the significant unmet medical needs in chronic cough and prurigo nodularis. The successful completion and positive outcomes of these trials could pave the way for regulatory approval and commercialization, which would be a significant achievement for the company and potentially transformative for patients with these conditions.

Trevi Therapeutics Inc (TRVI, Financial) is poised to participate in upcoming industry events, including the 23rd Annual Needham Virtual Healthcare Conference and the 3rd European Pulmonary Fibrosis Patient Summit 2024, which will provide further opportunities to engage with investors and stakeholders.

Investors and interested parties are invited to participate in today's conference call or access the webcast on the company's website. For more detailed financial information and updates on Trevi Therapeutics Inc (TRVI, Financial)'s clinical trials and business developments, please refer to the full 8-K filing.

Explore the complete 8-K earnings release (here) from Trevi Therapeutics Inc for further details.