Company: TVRD
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001104659-25-111289
Chunk: 10

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 2
Chunk 10
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 Phase 1 trial of TTI-109 in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics, as well as bioequivalence to TTI-101. The study is ongoing and Tvardi expects to report out topline data from this trial in the first half of 2026. In October 2025, Tvardi reported preliminary data from its Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF) and concluded that the study did not meet its goals. Tvardi is conducting additional analyses to further understand these results and inform next steps.

Since commencing operations in 2017, Tvardi has devoted substantially all of its efforts and financial resources to developing its product candidates, organizing and staffing its company, business planning, raising capital, establishing its intellectual property portfolio and performing research and development of its product candidates, signaling and biology, medicinal chemistry and clinical insights to discover and develop novel therapies for the treatment of fibrosis-driven diseases. Through the date of this filing, Tvardi has historically financed its operations principally through the issuance and sale of its preferred stock and convertible debt. Legacy Tvardi has received $28.3 million from the sale and issuance of its Convertible Notes (as defined below) in December 2024 and $83.4 million from the issuance and sale of its preferred stock and historical convertible debt, which was converted into preferred stock, in 2018 and 2021.

As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments. As further discussed below, in April 2025, Legacy Tvardi completed its Merger (as defined below) with Cara Therapeutics, Inc. (Cara), through which Legacy Tvardi acquired approximately $23.9 million in net assets. Tvardi has incurred net losses since inception. As of September 30, 2025 and December 31, 2024, its accumulated deficit was $103.2 million and $92.2 million, respectively. For the three and nine months ended September 30, 2025, Tvardi reported net losses of $5.5 million and $10.9 million, respectively. For the three and nine months ended September 30, 2024, Legacy Tvardi reported net losses of $5.5 million and $16.7 million, respectively. Tvardi’s net