TVRD — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-08

• On December 17, 2024, the Delaware corporation formerly known as Tvardi Therapeutics, Inc. (Legacy Tvardi) entered into an agreement and plan of merger and reorganization (the Merger Agreement) with Cara Therapeutics, Inc. (Cara), and CT Convergence Merger Sub, Inc., a wholly-owned subsidiary of Car…

• Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to “Tvardi,” the “Company,” “we,” “us,” “our” and other similar terms refer to the business and operations of Legacy Tvardi…

• We are a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet need. Based upon our founders' seminal wo…

• Our pipeline includes two oral, small molecule STAT3 inhibitors: TTI-101 and TTI-109. TTI-101 is our first-generation direct STAT3 inhibitor, currently in Phase 1b/2 clinical development in hepatocellular carcinoma (HCC). TTI-109 is a phosphate prodrug of TTI-101 that is mechanistically identical to…

• In October 2025, we reported preliminary data from our Phase 2 clinical trial of TTI-101 in IPF and concluded that the study did not meet its goals. Subsequently, we conducted additional analyses of a subset of patients who received study drug for 12 weeks. Based on these analyses, which excluded ce…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Tvardi 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. Based upon Tvardi’s founder’s seminal work and deep understanding of the transcription factor STAT3,…

• 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…

• 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 appr…

• that may prove to be wrong, and it could exhaust its capital resources sooner than it expects. See the subsection titled “— Liquidity and Capital Resources” below for further discussion.

• Tvardi will require additional funding in order to finance operations and complete its ongoing and planned clinical trials. Access to such funding on acceptable terms cannot be assured.

Text added vs the prior filing · source: 10-Q · 2026-05-08

• There have been no material changes to our quantitative and qualitative disclosures about market risk from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 31, 2026. Accordingly, the information required by this Item is incorporat…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments. As of December 31, 2024, Legacy Tvardi had $31.6 million in cash and cash equivalents. Tvardi’s cash, cash equivalents and short-term investments are primarily maintained in a…

• Inflation generally affects Tvardi by increasing the cost of labor and research and development contract costs. Tvardi does not believe inflation has had a material effect on its results of operations during the periods presented in its unaudited condensed consolidated financial statements included …

• All of Tvardi’s employees and its operations are currently located in the United States, and expenses are generally denominated in U.S. dollars. As such, Tvardi is not exposed to financial risks from exchange rate fluctuations between U.S. dollars and other currencies.

Text added vs the prior filing · source: 10-Q · 2026-05-08

• We did not design or maintain an effective control environment and lacked a sufficient number of professionals to consistently establish appropriate authorities and responsibilities in pursuit of our financial reporting objectives. The lack of sufficient number of finance and accounting professional…

• We have further identified material weaknesses in our internal control over financial reporting which relate to: (a) the lack of a formalized risk assessment process; (b) inadequate review of financial statements and disclosures; (c) inadequate review of the prepaid and accrued research and developm…

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Two of these material weaknesses are related to the fact that Legacy Tvardi lacked a sufficient number of professionals to consistently establish appropriate authorities and responsibilities in pursuit of Legacy Tvardi’s financial reporting objectives. The lack of sufficient number of finance and ac…

• Management’s Plan to Remediate the Legacy Tvardi Material Weaknesses

Text added vs the prior filing · source: 10-Q · 2026-05-08

• On March 6, 2026, Shaheen Wirk, Palkon Holdings, LLC, and Palkon TT Holdings, LLC filed a complaint in the Supreme Court of the State of New York, County of New York, alleging that we breached the Registration Rights Agreement, dated April 15, 2025, by and among us and the investors party thereto (R…

• We are, and from time to time, we may be subject to legal proceedings and claims arising in the ordinary course of our business. We are not currently a party or aware of any proceedings that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial …

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• Between December 20, 2024, and March 19, 2025, Cara received 13 demands (and three draft complaints) from purported stockholders of Cara (collectively, the Demands) challenging the disclosures in the proxy statement/prospectus (the Proxy Statement/Prospectus) included in the Registration Statement o…

• Cara and the other named defendants deny that they violated any laws or breached any duties to stockholders of Cara, and they believe that no supplemental disclosure was required to the Proxy Statement/Prospectus under any applicable law, rule or regulation. Nevertheless, solely to eliminate the bur…

• From time to time, Tvardi may be subject to legal proceedings and claims arising in the ordinary course of its business. Tvardi is not currently a party or aware of any proceedings that it believes will have, individually or in the aggregate, a material adverse effect on Tvardi’s business, financial…

Text added vs the prior filing · source: 10-Q · 2026-05-08

• Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and growth prospects. In such an event, the market price of our common stock could decline. In addition to the other information in this Quarterly Report on Form …

Text removed vs the prior filing · source: 10-Q · 2025-11-13

• You should carefully consider the risks described below, as well as the other information in this Quarterly Report on Form 10-Q, including the unaudited condensed consolidated financial statements and related notes and the section titled “Management’s Discussion and Analysis of Financial Condition a…

• ●Tvardi has a limited operating history, which may make it difficult to evaluate Tvardi’s prospects and likelihood of success.

• ●Tvardi has not generated any revenue to date and Tvardi may never become or remain profitable.

• ●Tvardi’s financial condition raises substantial doubt as to its ability to continue as a going concern.

• ●Tvardi will require substantial additional capital to fund its operations. If Tvardi is unable to raise such capital when needed, or on acceptable terms, it may be forced to delay, reduce and/or eliminate one or more of its research and drug development programs, future commercialization efforts or…