UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) May 12, 2025 Delaware 001-36279 75-3175693 (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) TVARDI THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Check the appropriate box below if the Form 8-K filing is intended ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 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. (Exact name of registrant as specified in its charter) Delaware 75-3175693 (State or other jurisdiction of incor ...

Merger creates a Nasdaq-listed, clinical-stage biopharmaceutical company – Tvardi Therapeutics – developing novel treatments targeting STAT3 to treat fibrosis-driven diseases Tvardi shares to begin trading under the symbol “TVRD” on April 16, 2025 Post-transaction cash and cash equivalents expected to fund operations into the second half of 2026 Tvardi anticipates reporting topline data from two Phase 2 clinical programs utilizing its STAT3 inhibitor, TTI-101, including its lead program in idiopathic pulmon ...

Core Points - Cara Therapeutics, Inc. has announced a 1-for-3 reverse stock split of its outstanding shares of common stock [1] - The company's common stock will begin trading under the new name "Tvardi Therapeutics, Inc." and the new symbol "TVRD" following the merger with Tvard Therapeutics, Inc. [2] - The reverse stock split was approved by stockholders and will reduce the number of outstanding shares from approximately 4.6 million to approximately 1.5 million [3][4] Company Overview - Tvardi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing oral small molecule therapies targeting STAT3 for fibrosis-driven diseases [7] - Cara Therapeutics is a biopharmaceutical company that has developed an IV formulation of difelikefalin for treating moderate-to-severe pruritus associated with advanced kidney disease [8]

Financial Performance - Total revenue for the year ended December 31, 2024, was $7.137 million, a decrease of 66% compared to $20.968 million in 2023[678]. - Collaborative revenue decreased to $2.086 million in 2024 from $12.936 million in 2023, representing an 84% decline[678]. - Research and development expenses for 2024 were $32.805 million, down from $108.510 million in 2023, a reduction of 70%[678]. - The net loss for 2024 was $70.867 million, compared to a net loss of $118.513 million in 2023, indicating a 40% improvement[678]. - The company reported an operating loss of $58.383 million for 2024, compared to an operating loss of $121.495 million in 2023, reflecting a 52% improvement[678]. - Basic and diluted net loss per share for 2024 was $15.53, compared to $26.26 in 2023, showing a 41% reduction[678]. - The net loss for the year ended December 31, 2024, was $70,867,000, a decrease from the net loss of $118,513,000 in 2023 and $85,474,000 in 2022[682]. - The Company recognized net losses of $70.9 million, $118.5 million, and $85.5 million for the years ended December 31, 2024, 2023, and 2022, respectively[697]. Assets and Liabilities - Cash and cash equivalents decreased to $37.903 million as of December 31, 2024, down from $51.775 million in 2023, a decline of 27%[677]. - Total current assets dropped significantly to $43.827 million in 2024 from $116.158 million in 2023, a decrease of 62%[677]. - Total stockholders' equity turned negative at $(4.593) million in 2024, down from $57.085 million in 2023[677]. - The Company had unrestricted cash and cash equivalents of $37.9 million and an accumulated deficit of $755.6 million as of December 31, 2024[697]. - The liability related to sales of future royalties and milestones increased to $44.448 million in 2024 from $37.079 million in 2023, a rise of 20%[677]. - Accounts payable and accrued expenses totaled $3,972 as of December 31, 2024, down from $25,592 as of December 31, 2023, a decrease of approximately 84%[815]. Investments and Securities - As of December 31, 2023, the company had invested $49.0 million in available-for-sale marketable securities with a yield of approximately 4.41%[658]. - The aggregate unrealized losses on available-for-sale marketable securities were $0.3 million as of December 31, 2023[661]. - The company has no available-for-sale marketable securities as of December 31, 2024, indicating a shift in investment strategy[659]. - The Company reviews available-for-sale marketable securities for unrealized losses at each balance sheet date and whenever circumstances indicate that the amortized cost basis may not be recoverable[718]. - The assessment of unrealized losses includes qualitative factors such as credit downgrades and the intent to sell the security, which may change based on new developments[720]. - If the Company intends to sell a security or is likely to be forced to sell it, the entire unrealized loss is recognized as a credit loss in net loss[721]. - The Company had an insignificant allowance for credit losses as of December 31, 2024 and 2023, indicating low credit risk associated with its licensing partners[733]. Revenue Recognition - Revenue is recognized based on the consideration expected in exchange for the transfer of goods or services, following a five-step process[747]. - The Company recognizes revenue when it satisfies a performance obligation by transferring a promised good or service to a customer, with revenue from licenses recognized when the customer has legal title and can direct the use of the license[755]. - Collaborative revenue includes the Company's share of profits from CSL Vifor's sale of KORSUVA injection, recognized in the period the product sales are earned[759]. - Commercial supply revenue is recognized when CSL Vifor obtains control of KORSUVA injection, typically upon receipt after passing quality testing[763]. - License and milestone fees include upfront and milestone payments associated with license agreements, recognized based on relative standalone selling prices[764]. - Royalty revenue from net sales of Kapruvia in Europe will not be recognized until the Company fulfills its obligations under the HCR Agreement starting October 1, 2023[765]. Strategic Initiatives - The company is exploring strategic alternatives to maximize shareholder value if the proposed merger with Tvardi Therapeutics does not consummate[12]. - The company entered into a merger agreement with Tvardi Therapeutics, Inc. on December 17, 2024, which is subject to stockholder approval[685]. - The Company plans to sell certain assets and rights related to difelikefalin to CSL Vifor for a purchase price of $900,000, subject to adjustments[686]. - The Company is subject to risks related to the completion of the merger with Tvardi, which could materially affect its financial results and stock price[19]. Workforce and Operations - The company underwent a workforce reduction of approximately 70% in June 2024 as part of a streamlined operating plan[684]. - G&A expenses consist primarily of salaries and related costs for personnel across various functions, with ongoing costs related to remaining personnel and consultants despite workforce reductions[770][771]. - The Company recognized restructuring expenses related to the discontinuation of oral programs in atopic dermatitis and chronic kidney disease, with workforce reductions planned throughout 2024[778]. Clinical Development - Difelikefalin injection, marketed as KORSUVA, received FDA approval in August 2021 and began commercial launch in the U.S. in April 2022[687]. - Difelikefalin injection was approved in multiple countries, including the EU and the UK, with commercial launches commencing in various member states[689]. - The company discontinued the clinical program for notalgia paresthetica on June 12, 2024, after failing to demonstrate meaningful clinical benefit in trials[684]. - The Company is responsible for clinical and non-clinical development, including R&D services, at its own cost[844]. Stock and Equity - The company increased its authorized common stock from 100 million shares to 200 million shares as of June 7, 2024, which may affect earnings per share and voting rights[822]. - Cara Therapeutics approved a one-for-twelve reverse stock split, reducing authorized shares from 200 million to 16.67 million[824]. - As of December 31, 2024, there were 4,571,229 shares of common stock issued and outstanding[824]. - The Company entered into a reverse stock split of 1-for-12, effective December 31, 2024, to help regain compliance with Nasdaq listing requirements[701]. - The Company is subject to potential delisting from Nasdaq due to non-compliance with bid price requirements, having received an extension until January 27, 2025, to regain compliance[699].

Core Points - Cara Therapeutics, Inc. announced a 1-for-12 reverse stock split effective December 30, 2024, reducing the number of outstanding shares from approximately 54.9 million to about 4.6 million [2][4] - The total number of authorized shares will decrease from 200 million to 16,666,667 [2][4] - The reverse stock split aims to help the company regain compliance with Nasdaq's minimum bid price requirement [3][8] Company Overview - Cara Therapeutics is a biopharmaceutical company focused on treating pruritus, with an approved IV formulation of difelikefalin for moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis [7]

Core Insights - The partnership between Alessia Cara, Lenovo, and Intel focuses on creating a visually stunning album trailer and miniseries that showcases the integration of creativity and technology [1][3] - The campaign titled "Made By Alessia Cara" will feature a three-part episodic series documenting the creative process behind the album trailer, highlighting how Lenovo and Intel's technology supports artistic vision [2][3] - Lenovo's Yoga Slim 7i Aura Edition and other devices are designed to empower creativity, featuring Intel Core Ultra processors that enhance productivity and user experience for creators [4] Company Insights - Lenovo is a global technology powerhouse with a revenue of US$57 billion, ranked 248 in the Fortune Global 500, and operates in 180 markets [7] - Lenovo's vision is to deliver Smarter Technology for All, focusing on AI-enabled devices and solutions to create a more equitable and smarter future [7] - Intel is recognized as an industry leader in semiconductor technology, continuously advancing design and manufacturing to address global challenges [8] Industry Insights - The collaboration between Universal Music Group for Brands, Lenovo, and Intel emphasizes the transformative role of technology in the music industry, enhancing storytelling and creative expression [3][9] - The campaign aims to inspire audiences by showcasing the synergy between music, art, and cutting-edge technology through immersive experiences [3][4] - The anticipated release of Alessia Cara's album trailer and episodic series in January 2025, followed by the album "Love & Hyperbole" on February 14, 2025, highlights the ongoing evolution of music marketing through innovative partnerships [5]

Group 1 - Monteverde & Associates PC is investigating Cara Therapeutics, Inc. regarding its proposed merger with Tvardi Therapeutics, Inc. [1] - Under the merger agreement, Cara Therapeutics stockholders are expected to own approximately 17.0% of the combined company [1] - Monteverde & Associates PC has a successful track record in recovering millions of dollars for shareholders and is recognized as a Top 50 Firm by ISS Securities Class Action Services Report [1][3] Group 2 - The firm is headquartered in the Empire State Building in New York City [1][3] - Monteverde & Associates PC is a national class action securities firm with experience in trial and appellate courts, including the U.S. Supreme Court [3]

Core Viewpoint - Cara Therapeutics and Tvardi Therapeutics have announced a definitive merger agreement to create a Nasdaq-listed biopharmaceutical company focused on developing novel treatments targeting STAT3 for fibrosis-driven diseases [1][2] Financial Overview - Tvardi has completed approximately $28 million in private financing, which, along with existing cash and Cara's anticipated cash balance, is expected to fund the combined company into the second half of 2026 [1][3] - Upon completion of the merger, pre-merger Cara stockholders are expected to own approximately 17.0% and pre-merger Tvardi stockholders approximately 83.0% of the combined company, subject to adjustments based on Cara's net cash at closing [2] Clinical Development - Tvardi anticipates reporting topline data in the second half of 2025 from two Phase 2 clinical programs utilizing its STAT3 inhibitor, TTI-101, targeting idiopathic pulmonary fibrosis and hepatocellular carcinoma [1][3] - The ongoing REVERTIPF trial is evaluating TTI-101's safety and efficacy in patients with idiopathic pulmonary fibrosis, with unblinded data expected in the second half of 2025 [9] - The REVERTLIVER CANCER trial is assessing TTI-101 in patients with hepatocellular carcinoma, with preliminary topline data also anticipated in the second half of 2025 [9] Management and Structure - Following the merger, the combined company will be headquartered in Houston, Texas, led by Tvardi's CEO, Imran Alibhai, Ph.D., and will have a board comprised of six directors from Tvardi and one from Cara [11] Strategic Partnerships - Concurrent with the merger agreement, Cara has entered into an asset purchase agreement with CSL Vifor to sell certain assets related to Korsuva/Kapruvia for a purchase price of $900,000, along with a $3 million compensation for future expenses [4][5][6]

Clinical Program Updates - The company announced a decision to discontinue the clinical program in notalgia paresthetica after the KOURAGE-1 study showed no meaningful clinical benefit from oral difelikefalin compared to placebo [170]. - R&D expenses are expected to significantly decrease in the future as the company focuses on strategic alternatives following the discontinuation of its NP program [245]. - The company anticipates focusing expenses on the discontinuation of its clinical program for oral difelikefalin and exploring strategic alternatives to maximize shareholder value [294]. Financial Performance - As of September 30, 2024, the company had shareholders' equity of $0.7 million, failing to meet the Nasdaq requirement of at least $2.5 million [178]. - For the nine months ended September 30, 2024, the company reported a net cash used in operating activities of $56.9 million, compared to $74.7 million for the same period in 2023 [317]. - The company incurred net losses of $63.2 million compared to $86.2 million for the same period in 2023, indicating a reduction in losses [293]. - Total revenue for Q3 2024 was $2.6 million, a decrease of 47% from $4.9 million in Q3 2023, and for the nine months ended September 30, 2024, it was $5.7 million, down 68% from $18.0 million in the same period of 2023 [263]. Shareholder Equity and Compliance - The company received an extension from Nasdaq until January 27, 2025, to regain compliance with the minimum closing bid price requirement of $1.00 per share [177]. - The company is assessing options to regain compliance with Nasdaq's Shareholders' Equity Requirement [178]. - The company has not yet implemented a reverse stock split, which was approved by stockholders, and the decision remains at the discretion of the Board of Directors [179]. Revenue and Sales - KORSUVA injection recorded net sales of approximately $3.0 million in the U.S. for the three months ended September 30, 2024, down from $4.4 million in the same period of 2023, resulting in a profit share of $1.3 million compared to $1.9 million [185]. - For the nine months ended September 30, 2024, KORSUVA injection net sales in the U.S. were approximately $2.1 million, significantly lower than $21.5 million for the same period in 2023, primarily due to higher rebates and chargebacks [185]. - Collaborative revenue from KORSUVA injection for the nine months ended September 30, 2024, was $2.1 million, a decrease from $10.1 million in the same period of 2023 [191]. Strategic Alternatives and Workforce Reduction - The company is exploring strategic alternatives to maximize shareholder value amid substantial uncertainties [164]. - A streamlined operating plan was approved, which includes a workforce reduction of approximately 70%, completed by June 30, 2024 [170]. - In January 2024, the company announced a workforce reduction of up to 50% to reduce operating expenses [251]. Milestone Payments and Agreements - The company is eligible for up to $440.0 million in commercial milestone payments based on sales and tiered double-digit royalty payments from CSL Vifor for KORSUVA injection [212]. - The company received a non-refundable upfront license fee of $15.0 million from Maruishi and is eligible for up to $10.5 million in clinical development and regulatory milestones [216]. - The company plans to achieve a $2.5 million milestone payment upon reaching a 2024 sales milestone for KORSUVA in Japan, expected in Q4 2024 [202]. Cost Management and Expenses - G&A expenses are anticipated to decrease due to workforce reductions, but may still include costs related to remaining personnel and strategic alternatives exploration [249]. - The decrease in R&D expenses was primarily due to the discontinuation of several oral difelikefalin programs and reductions in workforce [270]. - General and administrative expenses for Q3 2024 were $6.5 million, a decrease of 4% from $6.8 million in Q3 2023, and for the nine months ended September 30, 2024, they were $19.7 million, down 7% from $21.2 million in the same period of 2023 [272]. Cash Flow and Investments - The company expects to fund its capital requirements primarily with current unrestricted cash and cash equivalents [289]. - The company has raised an aggregate of $943.8 million to fund operations, including $447.4 million from public offerings and $258.8 million from license and supply agreements [299]. - As of September 30, 2024, the company had invested $5.0 million in marketable securities with a yield of approximately 0.90% [330]. Regulatory and Market Approvals - The IV formulation of oral difelikefalin is approved for treating moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis in the U.S., EU, and multiple other countries [171]. - Difelikefalin, the active ingredient in KORSUVA, is approved for treating moderate-to-severe pruritus associated with advanced CKD in multiple countries, including the U.S., EU, and Japan [186]. - The final CY 2024 rule from CMS established a post-TDAPA add-on payment of 65% for KORSUVA injection, effective April 1, 2024, but the unfavorable reimbursement has led to a lack of sequential revenue growth since the product's launch [185].