Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 COMMISSION FILE NUMBER: 001-36279 TVARDI THERAPEUTICS, INC. (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization ...

Exhibit 99.1 Tvardi Therapeutics Announces Fourth Quarter and Full-Year 2025 Results and Provides Business Update Results from healthy volunteer study of next-generation STAT3 inhibitor, TTI-109, on track for Q2 2026 Topline data from Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) are anticipated in H2 2026 Cash runway expected to be suf icient to fund operations into Q4 2026 after clinical readouts HOUSTON, TX – March 31, 2026 - Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-st ...

Financial Performance - Net loss for Q3 2025 was $5.5 million, roughly flat compared to the net loss of $5.5 million in Q3 2024, with a net loss per share of $0.59[9] - Cash, cash equivalents, and short-term investments as of September 30, 2025, were $36.5 million, an increase from $31.6 million as of December 31, 2024, with a cash runway anticipated to last into Q4 2026[10] - The balance sheet shows total assets of $39.0 million as of September 30, 2025, compared to $35.2 million as of December 31, 2024[17] Research and Development - Research and development expenses for Q3 2025 were $3.6 million, down from $4.8 million in Q3 2024, primarily due to lower costs associated with TTI-101 trials[7] - The company reported a decrease in expenses related to TTI-101 trials, with a $1.4 million reduction in HCC trial costs and a $1.0 million reduction in IPF trial costs[7] - Topline data from the Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) is expected in H1 2026[1] - Results from a healthy volunteer study of the next-generation STAT3 inhibitor, TTI-109, are also anticipated in H1 2026[1] - The Phase 2 REVERT IPF trial did not meet its goals, prompting further analysis to determine next steps[6] Operating Expenses - General and administrative expenses increased to $2.3 million in Q3 2025 from $0.9 million in Q3 2024, driven by higher professional fees and personnel costs[8] Strategic Focus - The company is focused on advancing its therapeutic potential in fibrosis-driven diseases through ongoing clinical trials[3]

Financial Performance - Tvardi reported net losses of $5.5 million and $10.9 million for the three and nine months ended September 30, 2025, respectively, compared to net losses of $5.5 million and $16.7 million for the same periods in 2024[129]. - The accumulated deficit as of September 30, 2025, was $103.2 million, up from $92.2 million as of December 31, 2024[129]. - The net loss for the three months ended September 30, 2025, was $5.5 million, a slight increase of 0.3% compared to a net loss of $5.5 million in 2024[193]. - Total operating expenses for the nine months ended September 30, 2025, were $19.2 million, an increase of 10.7% from $17.3 million in 2024[193]. - General and administrative expenses for the nine months ended September 30, 2025, totaled $6.6 million, a significant increase of 194.1% from $2.3 million in 2024[201]. - The increase in general and administrative expenses was primarily driven by a $2.7 million rise in professional fees due to legal and audit costs associated with the Merger[201]. - Other income, net for the nine months ended September 30, 2025, was $7.2 million, primarily due to a $12.8 million remeasurement gain on Convertible Notes, partially offset by a $4.9 million loss[205]. - Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2025, compared to $13.5 million for the same period in 2024, indicating a 31.6% increase in cash outflow[215]. - Net cash used in investing activities was $15.1 million for the nine months ended September 30, 2025, due to purchases of short-term investments[220]. - The net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $22.7 million, primarily from the Merger and stock option exercises[222]. Research and Development - Preliminary data from the Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF) indicated that the study did not meet its goals, with discontinuation rates of 56.7% and 62.1% for the 400mg and 800mg treatment arms, respectively[138][141]. - The Phase 2 trial enrolled 88 patients, with 58% receiving concomitant therapy, and demonstrated no statistically significant differences in efficacy between treatment arms[140][144]. - Tvardi's second product candidate, TTI-109, is currently in a Phase 1 trial, with topline data expected in the first half of 2026[127][147]. - Research and development expenses are expected to increase substantially as Tvardi continues to invest in the development of TTI-101 and TTI-109[180]. - Research and development expenses decreased to $3.6 million for the three months ended September 30, 2025, from $4.8 million in the same period of 2024, a reduction of 24.9%[194]. - Research and development expenses for the nine months ended September 30, 2025, were $12.5 million, down 16.8% from $15.0 million in 2024[196]. Cash and Investments - As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments[129]. - As of September 30, 2025, there were 551,221 shares of Tvardi's common stock remaining available for grant under the 2025 Equity Incentive Plan[154]. - As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments, down from $31.6 million in cash and cash equivalents as of December 31, 2024[256]. Financing and Capital Structure - The company has historically financed operations through the issuance of preferred stock and convertible debt, raising $28.3 million from Convertible Notes and $83.4 million from preferred stock and convertible debt in 2018 and 2021[128]. - Following the merger with Cara Therapeutics, Tvardi acquired approximately $23.9 million in net assets[129][148]. - Following the Merger, equity holders of Legacy Tvardi owned approximately 84.5% of the outstanding Tvardi common stock on a fully diluted basis[151]. - The Convertible Notes issued by Legacy Tvardi in December 2024 had an aggregate principal amount of approximately $28.3 million, accruing interest at 8% per annum[155]. - Upon the closing of the Merger, the outstanding principal balance of the Convertible Notes converted into 1,265,757 shares of Tvardi common stock, resulting in a gain of $12.8 million recorded in Q2 2025[156]. - Future funding requirements will depend on various factors, including the costs and timing of clinical trials and regulatory approvals[214]. - Tvardi plans to seek additional funding through equity offerings or debt financings following its Merger with Cara in April 2025[210]. Market and Operational Risks - Tvardi has an accumulated deficit of $103.2 million as of September 30, 2025, raising substantial doubt about its ability to continue as a going concern[210]. - The company has incurred significant operating losses since inception and does not expect to generate revenue from product sales for several years[208]. - The fair value of the Convertible Notes at the time of conversion was $23.1 million, with a change in fair value of $12.8 million recorded as other income for Q2 2025[244]. - Tvardi's primary exposure to market risk is interest rate sensitivity, with an immediate 10% change in interest rates expected to have no material effect on fair market value[256]. - Inflation has not had a material effect on Tvardi's results of operations during the reported periods[257]. - The company has not made any material adjustments to its prior estimates of accrued research and development expenses[235]. - Payments under contracts with service providers depend on successful patient enrollment and completion of clinical trial milestones[235].

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on October 20, 2025 Registration No. 333-287675 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 TVARDI THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 75-3175693 (Primary Standard Industrial Classification Code Number) (I.R.S. Emp ...

Core Insights - Tvardi Therapeutics (NASDAQ: TVRD) has advanced its pipeline to public trading through a merger with Cara Therapeutics, enhancing its market presence and potential for growth [2]. Company Overview - Tvardi Therapeutics is now publicly traded following its merger, which signifies a strategic move to leverage its pipeline and expand its operations in the biotech sector [2]. Investment Analysis - The Biotech Analysis Central service offers comprehensive analysis on various pharmaceutical companies, including a model portfolio of over 10 small and mid-cap stocks, aimed at assisting healthcare investors in making informed decisions [2].

Table of Contents As filed with the Securities and Exchange Commission on October 7, 2025 Registration No. 333-287675 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 TVARDI THERAPEUTICS, INC. (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 75-3175693 (I.R.S. Empl ...

Financial Performance - Tvardi Therapeutics reported a net income of $4.2 million for Q2 2025, compared to a net loss of $7.0 million in Q2 2024, primarily due to a $12.8 million remeasurement gain on Convertible Notes[10] - Research and development expenses decreased to $5.8 million in Q2 2025 from $6.5 million in Q2 2024, a reduction of approximately 10.8%[8] - General and administrative expenses increased to $3.1 million in Q2 2025 from $650,000 in Q2 2024, reflecting a rise of approximately 376.9% due to higher professional fees related to the merger[9] Cash and Assets - Cash, cash equivalents, and short-term investments as of June 30, 2025, were $41.0 million, up from $31.6 million as of December 31, 2024[11] - The total assets of Tvardi increased to $43.75 million as of June 30, 2025, compared to $35.20 million as of December 31, 2024[17] - Total liabilities decreased significantly to $10.82 million as of June 30, 2025, from $40.83 million as of December 31, 2024[17] - The company anticipates sufficient cash runway to fund operations into Q4 2026[4] Clinical Development - The company is on track to report topline data from the REVERT IPF Phase 2 clinical trial in Q4 2025[4] - An Investigational New Drug (IND) application for the second clinical candidate, TTI-109, was submitted to the FDA in June 2025[6] Corporate Changes - The merger with Cara Therapeutics has transitioned Tvardi into a publicly traded company[6]

Financial Performance - Tvardi reported a net income of $4.2 million for the three months ended June 30, 2025, compared to a net loss of $7.0 million for the same period in 2024[128]. - Net income for the three months ended June 30, 2025, was $4.2 million, a substantial improvement from a net loss of $7.0 million in the same period of 2024, reflecting a 159.7% change[175]. - Other income for the three months ended June 30, 2025, was $12.7 million, primarily due to a $12.8 million remeasurement gain on Legacy Tvardi's Convertible Notes[187]. - Interest income rose to $0.4 million for the three months ended June 30, 2025, compared to $0.2 million in 2024, indicating an 83.0% increase[185]. - Total operating expenses for the six months ended June 30, 2025, were $13.2 million, up from $11.6 million in 2024, reflecting a 13.7% increase[175]. - General and administrative expenses increased significantly to $3.1 million for the three months ended June 30, 2025, compared to $0.7 million in 2024, marking a 371.2% increase[182]. - General and administrative expenses for the six months ended June 30, 2025, totaled $4.3 million, up from $1.4 million in 2024, a 212.7% increase[183]. - The company has not generated any revenue from product sales and does not expect to do so for several years[189]. - As of June 30, 2025, Tvardi has an accumulated deficit of $97.6 million and incurred a net loss of $5.4 million for the six months ended June 30, 2025[192][199]. Cash and Investments - As of June 30, 2025, Tvardi had $20.6 million in cash and cash equivalents and $20.3 million in short-term investments[128]. - Tvardi had $20.6 million in cash and cash equivalents and $20.3 million in short-term investments as of June 30, 2025, down from $31.6 million in cash and cash equivalents as of December 31, 2024[236]. - Net cash used in operating activities was $13.6 million for the six months ended June 30, 2025, compared to $6.8 million for the same period in 2024[198][200]. - Tvardi's net cash used in investing activities was $20.4 million for the six months ended June 30, 2025, primarily due to purchases of short-term investments[201]. Clinical Development - Tvardi's lead product candidate, TTI-101, is in Phase 2 clinical development, with unblinded data expected in Q4 2025[126]. - The company expects to report preliminary topline data from its Phase 1b/2 HCC clinical trial in the first half of 2026[126]. - The company anticipates substantial increases in research and development expenses as it continues to invest in TTI-101 and TTI-109, with higher costs expected for clinical development compared to preclinical[163]. - Tvardi expects to incur approximately $400,000 in oncology-related costs and $300,000 in non-oncology-related costs for the initiation of Phase 3 clinical trials[146]. - The company reported a $1.9 million increase in costs related to the IPF trial due to patient enrollment timing, with the trial fully enrolled as of June 30, 2025[180]. Expenses and Future Funding - The company anticipates significant increases in expenses and capital requirements as it advances its clinical development activities[130]. - Tvardi may need substantial additional capital in the future to support ongoing development efforts and cannot predict when material net cash inflows will commence from product sales or licensing[164]. - Future funding requirements will depend on various factors, including the costs and results of clinical trials and regulatory requirements[195][196]. - The company plans to seek additional funding through equity offerings or debt financings following its merger, which provided approximately $23.9 million in net assets[192][204]. - Tvardi anticipates significant and increasing expenses as it advances its product candidates and expands its corporate infrastructure[193]. Agreements and Liabilities - Following the merger with Cara Therapeutics, Legacy Tvardi's equity holders owned approximately 84.5% of the outstanding common stock of Tvardi on a fully diluted basis[136]. - The merger resulted in Tvardi acquiring approximately $23.9 million in net assets[138]. - Tvardi issued convertible promissory notes totaling approximately $28.3 million in December 2024, which converted into 1,265,757 shares of common stock upon the merger[141][142]. - The BCM First Agreement requires Legacy Tvardi to pay annual maintenance fees ranging from $30,000 to $50,000, with royalties based on a low-single-digit percentage of net sales of licensed products[145]. - Tvardi is required to pay one-time milestone payments of up to $2,200,000 for the first BCM1 Licensed Product upon achieving specified development and regulatory milestones[145]. - The company has future operating lease liabilities of $0.3 million as of June 30, 2025, related to its corporate office space lease[205]. Stock and Valuation - The fair value of the Convertible Notes at conversion was $23.1 million, based on 1,265,757 shares of common stock at the closing market price on April 16, 2025[224]. - A change in fair value of $12.8 million was recorded, comparing the $23.1 million at conversion to the $35.9 million recorded value prior to conversion, impacting other income for the three months ended June 30, 2025[224]. - As of June 30, 2025, there were no Convertible Notes outstanding following their conversion into common stock[225]. - The estimated fair value of Legacy Tvardi's common stock was $0.92 and $0.82 as of June 30, 2023, and June 30, 2022, respectively[233]. - Tvardi's stock-based compensation expense is measured based on the fair value of stock options at the date of grant, using the Black-Scholes option-pricing model[226]. - Expected volatility for stock options was estimated using historical volatility of peer companies due to the lack of trading history for Legacy Tvardi's common stock prior to the Merger[232]. - Tvardi does not anticipate declaring dividends, estimating the dividend yield to be zero[232]. Miscellaneous - As of June 30, 2025, there was no current or deferred income tax expense or benefit due to the company's losses and full valuation allowance[171]. - No payments were made or incurred under the BCM Second Agreement during the three and six months ended June 30, 2025 and 2024, and no royalty fees have been incurred to date[156]. - The company does not believe inflation has materially affected its results of operations during the reported periods[238]. - Tvardi is not exposed to foreign currency exchange risks as all operations and expenses are denominated in U.S. dollars[239].

[Filing Information](index=1&type=section&id=Filing%20Information) Details the general filing information for Tvardi Therapeutics, Inc., including its stock exchange listing [General Information](index=1&type=section&id=General%20Information) Details the Form 8-K filing, registrant Tvardi Therapeutics, Inc., its incorporation, address, and Nasdaq stock listing - Registrant is **TVARDI THERAPEUTICS, INC.** (formerly Cara Therapeutics, Inc.)[2](index=2&type=chunk)[5](index=5&type=chunk) Stock Exchange Registration | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.001 per share | TVRD | The Nasdaq Stock Market LLC | [Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) Reports the company's Q1 2025 financial results, announced via a press release [Q1 2025 Financial Results Announcement](index=2&type=section&id=Q1%202025%20Financial%20Results%20Announcement) Tvardi Therapeutics, Inc. announced Q1 2025 financial results via a May 13, 2025 press release, furnished as Exhibit 99.1 - The Company issued a press release on **May 13, 2025**, announcing financial results for the fiscal quarter ended **March 31, 2025**[5](index=5&type=chunk) - The press release (Exhibit 99.1) is furnished under Item 2.02 and is not deemed 'filed' for Section 18 of the Securities Exchange Act or Sections 11 and 12(a)(2) of the Securities Act[5](index=5&type=chunk)[6](index=6&type=chunk) [Changes in Registrant's Certifying Accountant](index=2&type=section&id=Item%204.01.%20Changes%20in%20Registrant's%20Certifying%20Accountant.) Outlines the dismissal of Ernst & Young LLP and the engagement of Deloitte & Touche LLP as the new independent auditor [Dismissal of Independent Registered Public Accounting Firm](index=2&type=section&id=(a)%20Dismissal%20of%20Independent%20Registered%20Public%20Accounting%20Firm) The Audit Committee dismissed Ernst & Young LLP (EY) as the independent auditor, effective upon Q1 2025 Form 10-Q filing, with no prior disagreements or adverse opinions - **Ernst & Young LLP (EY)** was dismissed as the independent registered public accounting firm, effective after filing the Q1 2025 Form 10-Q[7](index=7&type=chunk) - EY's audit reports for **2024** and **2023** contained no adverse opinion, disclaimer, qualification, or modification[8](index=8&type=chunk) - No 'disagreements' or 'reportable events' occurred with EY during fiscal years **2024**, **2023**, and the subsequent interim period through **May 12, 2025**[9](index=9&type=chunk) [Engagement of New Independent Registered Public Accounting Firm](index=2&type=section&id=(b)%20Engagement%20of%20New%20Independent%20Registered%20Public%20Accounting%20Firm) Deloitte & Touche LLP was engaged as the new independent auditor for fiscal year 2025, effective May 13, 2025, with no prior consultations on accounting principles - **Deloitte & Touche LLP** was engaged as the independent registered public accounting firm for fiscal year ending **December 31, 2025**[11](index=11&type=chunk) - Deloitte previously served as the independent auditor for **Legacy Tvardi** before the merger[11](index=11&type=chunk) - No consultations occurred with Deloitte regarding accounting principles, audit opinions, or any 'disagreement' or 'reportable event'[11](index=11&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) Lists all financial statements and exhibits filed with the Form 8-K [Exhibits List](index=3&type=section&id=Exhibits%20List) Lists all exhibits filed with the Form 8-K, including a letter from Ernst & Young LLP, the financial results press release, and the Cover Page Interactive Data File Filed Exhibits | Exhibit No. | Description | | :---------- | :---------- | | 16.1 | Letter from Ernst & Young LLP to the SEC dated May 13, 2025 | | 99.1 | Press release issued on May 13, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |