Tvardi Therapeutics, Inc.
4.7800+0.06 (+1.27%)
Oct 29, 4:00:00 PM EDT · NasdaqCM · TVRD · USD
Key Stats
Market Cap
44.82MP/E (TTM)
-Basic EPS (TTM)
-2.25Dividend Yield
0%Recent Filings
8-K
Phase 2 IPF trial misses goals
Tvardi Therapeutics announced on October 13, 2025, that preliminary data from its Phase 2 REVERT trial of TTI-101 in idiopathic pulmonary fibrosis failed to meet goals, showing no significant FVC improvements over placebo amid high discontinuation rates from gastrointestinal issues, especially with nintedanib. Baseline FVC was lower in the placebo arm, complicating comparisons, while treated groups saw mean declines of -61.1 mL and -102.8 mL at 12 weeks versus -22.2 mL for placebo. The company holds $41.0 million in cash to fund operations into Q4 2026, with upcoming data from TTI-101 in hepatocellular carcinoma and TTI-109 in healthy volunteers expected in H1 2026. High variability clouds definitive insights.
8-K
Q2 profit amid trial progress
Tvardi Therapeutics reported Q2 2025 net income of $4.2 million, swinging from a $7.0 million loss last year, fueled by a $12.8 million gain on convertible notes remeasurement post-merger with Cara Therapeutics. Enrollment wrapped in the Phase 2 REVERT IPF trial for TTI-101, with topline data due Q4 2025; the liver cancer trial advances toward H1 2026 results. Cash hit $41.0 million, funding operations into Q4 2026. Yet clinical outcomes remain uncertain.
10-Q
Q2 FY2025 results
Tvardi Therapeutics swung to a Q2 net income of $4.2M, up from a $7.0M loss y/y, thanks to a $12.8M gain on convertible notes conversion during its April 2025 merger with Cara, which added $23.9M in net assets and boosted cash to $20.6M plus $20.3M in short-term investments. Operating losses widened to $8.9M from $7.2M y/y, driven by R&D costs for TTI-101's IPF trial (up 109% to $2.8M) and TTI-109 development, offset by cuts in HCC and discontinued mBC programs; G&A jumped 371% to $3.1M on merger fees. YTD net loss narrowed to $5.4M from $11.2M, with operating cash use at $13.6M. Merger closed April 15, 2025, converting notes and preferred stock to common, recognizing no goodwill. Liquidity supports runway into late 2025, but going concern doubt persists without fresh funding. Clinical trial delays from enrollment hurdles pose key risks.
8-K
Board member resigns amicably
Tvardi Therapeutics announced the resignation of board member Shaheen Wirk on July 8, 2025, effective immediately, with no disagreements cited. Wirk, who joined in March 2024 after serving as a special advisor, contributed significantly to strategic efforts. The board expressed gratitude for his input. This departure leaves a gap in advisory expertise amid ongoing therapeutic development.
8-K
Tvardi updates STAT3 pipeline presentation
Tvardi Therapeutics updated its corporate presentation on June 6, 2025, spotlighting STAT3 inhibitors for fibrosis-driven diseases. TTI-101 shows preclinical reversal of lung fibrosis and encouraging Phase 2 trends in IPF lung function, with unblinded data due in 4Q:2025; in HCC, it delivers partial responses in monotherapy and combos, topline Phase 1b/2 results in 1H:2026. TTI-109 IND filed June 2025. Multiple catalysts ahead, yet forward-looking statements carry risks.
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