Tvardi Therapeutics Q2 2025: IPF Enrollment Complete, Q4 Data Expected.

• Tvardi Therapeutics announces Q2 2025 results, on track for multiple Phase 2 data readouts. • Lead program in IPF expected in Q4 2025. • Cash runway anticipated to fund operations into Q4 2026. • REVERT IPF clinical trial enrollment completed. • TTI-101 topline data on track for Q4 2025.

Houston, TX – Tvardi Therapeutics, Inc. (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on developing novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, has announced its financial and operating results for the second quarter ended June 30, 2025. The company reported a significant improvement in net income, driven by a remeasurement gain on its Convertible Notes. Additionally, Tvardi provided updates on its clinical trials and financial outlook.

Key Highlights:

- Clinical Milestones: Tvardi completed enrollment in its REVERT IPF clinical trial, a Phase 2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF). Topline data from this trial is expected in the fourth quarter of 2025. The company also submitted an Investigational New Drug (IND) application for its second clinical candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025.
- Financial Performance: Research and development expenses for the quarter were $5.8 million, a decrease of $0.7 million compared to the same period in 2024. General and administrative expenses increased to $3.1 million due to professional fees and other costs associated with the merger with Cara Therapeutics. Net income for the quarter was $4.2 million, compared to a net loss of $7.0 million in the same period in 2024. This improvement was primarily due to a $12.8 million remeasurement gain on Tvardi’s Convertible Notes.
- Cash Position: As of June 30, 2025, Tvardi reported $41.0 million in cash, cash equivalents, and short-term investments, compared to $31.6 million as of December 31, 2024. The company anticipates that its cash runway will be sufficient to fund operations through the fourth quarter of 2026.

Upcoming Milestones:

- Data from the ongoing REVERT IPF Phase 2 clinical trial of TTI-101 is anticipated in the fourth quarter of 2025.
- Preliminary topline data from the REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 is expected in the first half of 2026.

About Tvardi Therapeutics:

Tvardi Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708).

Forward-Looking Statements:

The statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties, including the uncertainties associated with Tvardi’s product candidates, the clinical development and regulatory approval of product candidates, and the company’s ability to attract, hire, and retain skilled executive officers and employees. All forward-looking statements speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

References:

[1] https://www.stocktitan.net/news/TVRD/tvardi-therapeutics-announces-second-quarter-2025-results-and-2f2jxlnkrphg.html