TVRD

Reported topline healthy volunteer results for next-generation STAT3 inhibitor TTI-109, confirming the prodrug design, improved tolerability and reductions in disease-relevant immune cell populations Announced ulcerative colitis (UC) as the initial disease indication for TTI-109 and will host a KOL webinar on the clinical potential of TTI-109 in UC on August 19, 2026, at 11:00 a.m. ET HOUSTON, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi” or the “Company”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, today reported its financial and operating results for the second quarter ended June 30, 2026, and provided a business update. Recent Developments Reported topline results from the healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, confirming prodrug design, improved tolerability and pharmacodynamic evidence of STAT3 target engagement. Selected UC as the initial disease indication for TTI-109, based on its ability to modulate multiple pathogenic pathways downstream of STAT3 simultaneously. Announced that the Company will host a KOL webinar on the clinical potential of TTI-109 in UC featuring Randy Longman, MD, PhD (Weill Cornell Medicine) on August 19, 2026, at 11:00 a.m. ET. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “Since our last quarterly report, we have made significant progress in the clinical development of our STAT3 inhibitors. Regarding our next-generation STAT3 inhibitor, TTI-109, we were enthusiastic to see modulation of disease-relevant immune cell population even in healthy volunteers. We believe this bodes well for the development of TTI-109 in inflammatory and proliferative diseases, like UC.” Key Upcoming Milestones August 19, 2026: KOL webinar with Randy Longman, M.D., Ph.D., on the UC treatment landscape and TTI-109. To register, please click here 4Q 2026: TTI-101 Phase 1b/2 HCC topline data 2027: Initiation of clinical trial of TTI-109 in UC, subject to clearance of Investigational New Drug (IND) application and additional funding Second Quarter 2026 Financial Results Research and development expenses for the three months ended June 30, 2026, were $4.0 million as compared to $5.8 million for the comparable period in 2025. The decrease was primarily driven by lower clinical costs associated with TTI-101, partially offset by higher development costs associated with TTI-109. General and administrative expenses were $2.6 million for the three months ended June 30, 2026, as compared to $3.1 million for the three months ended June 30, 2025. The decrease was primarily driven by lower professional fees, reflecting higher accounting and consulting costs in the comparable 2025 period associated with the Company's April 2025 merger, partially offset by higher legal and investor relations costs associated with operating as a public company. Net loss for the three months ended June 30, 2026, was $6.5 million, compared to net income of $4.2 million for the three months ended June 30, 2025. Net income in the prior-year period reflected a $12.7 million non-cash gain from the change in fair value of the Company's convertible notes, which converted into common stock in connection with the Company's merger with Cara Therapeutics in April 2025. Basic and diluted net loss per share attributable to common shareholders for the three months ended June 30, 2026, were both $(0.69). Basic net income per share attributable to common shareholders for the three months ended June 30, 2025 was $0.51, and diluted net loss per share for the same period was $(1.00), reflecting the dilutive impact of the Company's convertible notes prior to their conversion into common stock in April 2025. Cash, cash equivalents and short-term investments as of June 30, 2026, were $15.8 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash, cash equivalents and short-term investments will be sufficient to fund operations, as currently planned, through the HCC topline readout into the third quarter of 2027. Advancing TTI-109 into UC and additional indications will require additional funding and IND clearance. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The Company is conducting clinical trials with TTI-109 in healthy volunteers and TTI-101 in hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials or safety or other complications related to its product candidates; the ability to obtain IND clearance for TTI-109 in UC on the timelines expected or at all; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Annual Report on Form 10-K for the year ended December 31, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: For Tvardi:Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors [email protected]

Topline results from healthy volunteer study and clinical development strategy for next-generation STAT3 inhibitor, TTI-109, anticipated in June Topline data from Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) on track for 2H 2026 Cash runway expected to be sufficient to fund operations through clinical readouts and into Q4 2026 HOUSTON, May 08, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, today reported its financial and operating results for the first quarter ended March 31, 2026, and provided a business update. Recent Progress and Upcoming Catalysts: TTI-109 (Healthy Volunteer Study): Study ongoing with topline data anticipated in June 2026. The Company plans to announce the clinical development strategy based on these results. TTI-101 (HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track to report topline results in 2H 2026. TTI-101 (IPF – REVERT IPF study additional analyses): Phase 2 trial showed that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo. Treatment with TTI-101 was also associated with a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “We are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results are expected to inform our future clinical development strategy.” “TTI-109 is designed to build on the preclinical and clinical activity observed with TTI-101 while potentially offering improved tolerability through its prodrug profile and enabling broader development across inflammatory and proliferative diseases driven by STAT3.” “In parallel, we remain on track to report topline data from our ongoing Phase 2 REVERT LIVER CANCER trial in the second half of this year. Prior interim findings demonstrated clinically meaningful activity across treatment settings, and we look forward to evaluating the full dataset.” “We continue to make significant progress advancing both programs, providing line of sight to two near-term value inflection points,” Dr. Alibhai concluded. Key Upcoming Milestones: June 2026: TTI-109 Phase 1 healthy volunteer topline data and clinical development strategy 2H 2026: TTI-101 Phase 1b/2 HCC topline data First Quarter 2026 Financial Results Research and development expenses for the three months ended March 31, 2026, were $4.9 million as compared to $3.1 million for the comparable period in 2025. The increase was primarily driven by higher TTI-109 developmental costs, partly offset by declining clinical costs associated with TTI-101. General and administrative expenses were $2.1 million for the three months ended March 31, 2026, as compared to $1.2 million for the three months ended March 31, 2025. The increase was primarily driven by higher personnel costs, including stock-based compensation, and professional fees, including costs associated with being a publicly traded company. Net loss for the three months ended March 31, 2026, was $6.8 million, as compared to a net loss of $9.6 million for the comparable period in 2025. Basic and diluted net loss per share attributable to common shareholders for the three months ended March 31, 2026, were a net loss of $(0.73), compared to a net loss of $(3.72) for the comparable period in 2025. Cash, cash equivalents and short-term investments as of March 31, 2026, were $25.0 million, as compared to $30.8 million as of December 31, 2025. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled, proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting clinical trials with TTI-109 in healthy volunteers and TTI-101 in hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward- looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Annual Report on Form 10-K for the year ended December 31, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: For Tvardi: Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors 617-430-7579 [email protected]

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 sufficient to fund operations into Q4 2026 after clinical readouts HOUSTON, March 31, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, today announced its financial and operating results for the fourth quarter and full-year ended December 31, 2025, and provided a business update. Recent Highlights: Additional analysis from the REVERT IPF Phase 2 trial demonstrated that TTI-101 was associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo, as well as a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine. These findings are consistent with preclinical data demonstrating reductions in established fibrosis and inflammatory signaling across multiple validated disease models. The healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, is ongoing, with topline data anticipated in the second quarter of 2026. The ongoing Phase 1b/2 REVERT LIVER CANCER trial will report topline results in the second half of 2026 to allow the data additional time to mature. This timing adjustment is intended to enhance the depth of insights gleaned from the program, including longitudinal and translational assessments, characterization of durability and dose optimization (including the addition of up to 15 participants in the monotherapy arm to explore once-a-day dosing), to better inform subsequent development and regulatory strategy. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “We entered 2026 with line-of-site to two significant clinical milestones: 1) healthy volunteer data from our next-generation STAT3 inhibitor, TTI-109, in the second quarter of this year, and 2) topline data from our ongoing Phase 2 trial of TTI-101 in HCC, which we anticipate in the second half.” “Further analysis of data from our Phase 2 IPF trial of TTI-101 that we announced in October revealed compelling trends. These data give us optimism for TTI-109, which has been developed to enhance TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability.” “At the same time, we eagerly await data from our ongoing Phase 2 REVERT LIVER CANCER trial, with a data readout expected in the second half of this year to allow for further data maturation. Interim results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines, and we believe the broader dataset will better position us to define the optimal development path and regulatory strategy for this important program.” “I believe we are well positioned to continue to advance these promising molecules, potentially offering new hope to patients requiring new, more effective treatment options while creating enduring value for our company,” Dr. Alibhai concluded. Upcoming Milestones: Preliminary topline data from a healthy volunteer study of the company’s next-generation STAT3 inhibitor, TTI-109, anticipated in the second quarter of 2026 Preliminary topline data from the company’s ongoing REVERT LIVER CANCER Phase 1b/2 clinical trial of TTI-101, anticipated in the second half of 2026 Fourth Quarter and Full-Year 2025 Financial Results Research and development expenses for the three months ended December 31, 2025, were $5.5 million as compared to $8.6 million for the comparable period in 2024. For the full year 2025, research and development expenses were $18.0 million, as compared to $23.7 million for the full year 2024. The decrease was primarily driven by declining clinical costs associated with TTI-101 offset by an increase in TTI-109 developmental costs. General and administrative expenses were $2.1 million for the three months ended December 31, 2025, as compared to $2.2 million for the three months ended December 31, 2024. For the full year 2025, general and administrative expenses were $8.7 million, as compared to $4.5 million for the full year 2024. The increase was primarily driven by increases in professional fees, attributable to increased legal, accounting and audit fees incurred as a result of the merger with Cara Therapeutics and subsequent filings as a public company. Net loss for the three months ended December 31, 2025, was $7.3 million, as compared to a net loss of $12.7 million for the comparable period in 2024. For the full year 2025, net loss was $18.2 million, as compared to a net loss of $29.4 million for the full year 2024. Basic and diluted net loss per share attributable to common shareholders for the three months ended December 31, 2025, were a net loss of $(0.78) on a basic and diluted basis, compared to a net loss of $(4.94) on a basic and diluted basis for the comparable period in 2024. For the full year 2025, basic and diluted net loss attributable to common stockholders were $(2.46) and $(3.26), respectively, as compared to basic and diluted loss attributable to common stockholders of $(11.42) for the full year 2024. Cash, cash equivalents and short-term investments as of December 31, 2025, were $30.8 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026. About Tvardi Therapeutics Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled, proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting clinical trials with TTI-101 in hepatocellular carcinoma (NCT05440708) and TTI-109 in healthy volunteers. To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward- looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: For Tvardi: Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors 617-430-7579 [email protected] TVARDI THERAPEUTICS Consolidated Statement of Operations (unaudited)

On track for topline data from Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) in H1 2026 Results from healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, expected in H1 2026 Cash runway sufficient to fund operations into Q4 2026 HOUSTON, November 13, 2025--(BUSINESS WIRE)--Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced its financial and operating results for the third quarter ended September 30, 2025, and provided a business update. Third Quarter 2025 and Recent Highlights: Continued to progress its Phase 2 study of TTI-101 in HCC, with topline data anticipated in the first half of 2026. Announced that the IND for its next-generation STAT3 inhibitor, TTI-109, is in effect and that a healthy volunteer study has been initiated, results of which are anticipated in the first half of 2026. In October, the company reported preliminary data from the Phase 2 REVERT IPF trial and concluded that the study did not meet its goals. Tvardi is conducting additional analyses to further understand these results and inform next steps. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "While we continue to analyze the results from our REVERT IPF clinical trial to determine the most appropriate path forward, we remain confident in the potential of STAT3 inhibition to address fibrosis-driven diseases. We believe our lead program, TTI-101, has demonstrated encouraging clinical activity in oncology and continues to hold promise across a range of indications where STAT3 is a key driver. "To that end, we eagerly await data from our ongoing Phase 2 REVERT Liver Cancer trial in the first half of next year. Interim results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established anti-cancer agents across treatment lines. "At the same time, we are also advancing our next-generation STAT3 inhibitor, TTI-109, through a healthy volunteer study. TTI-109 is designed to rapidly convert to TTI-101 and lessen the exposure of the active drug to the intestinal lining. We believe TTI-109 strengthens our STAT3-targeted approach by providing a more efficient delivery mechanism for TTI-101 that has the potential to improve tolerability. "With a balance sheet extending into the fourth quarter of next year, we remain focused on fully realizing the therapeutic potential of STAT3 inhibition across fibrotic diseases." Upcoming Milestones: Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in the first half of 2026 Preliminary topline data from a healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, also anticipated in the first half of 2026 Third Quarter 2025 Financial Results Research and development expenses for the three months ended September 30, 2025, were $3.6 million as compared to $4.8 million for the comparable period in 2024. The decrease of $1.2 million was primarily driven by lower costs associated with TTI-101, including decreases of $1.4 million and $1.0 million related to Tvardi’s HCC and IPF trials, respectively. The decrease in Tvardi’s HCC trial expense was primarily attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s IPF trial expense was attributable to the trial being completed in the second quarter of 2025. These declines were partly offset by an increase of $2.0 million related to the ongoing healthy volunteer study of TTI-109, which began in the third quarter of 2025, as well as related CMC costs. General and administrative expenses were $2.3 million for the three months ended September 30, 2025, compared to $0.9 million for the three months ended September 30, 2024. The increase of approximately $1.5 million was primarily driven by increases in professional fees of $0.7 million, attributable to higher legal fees and ongoing accounting and audit fees. The remaining increase was attributable to higher personnel costs, insurance costs and rent and other related costs. Net loss for the three months ended September 30, 2025 was $5.5 million, roughly flat with the comparable period in 2024. Basic and diluted net loss per share attributable to common shareholders for the three months ended September 30, 2025 were a net loss of $0.59 on a basic and diluted basis, compared to a net loss of $2.14 on a basic and diluted basis for the comparable period in 2024. Cash, cash equivalents and short-term investments as of September 30, 2025, were $36.5 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, into the fourth quarter of 2026. About Tvardi Therapeutics 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. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting clinical trials with TTI-101 in hepatocellular carcinoma (NCT05440708) and TTI-109 in healthy volunteers. To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; the final results of its clinical trial of TTI-101 in IPF; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward- looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20251113079476/en/ Contacts For Tvardi: Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors 617-430-7579 [email protected]

Tvardi Therapeutics recently announced preliminary results from its Phase 2 REVERT trial in idiopathic pulmonary fibrosis, revealing that TTI-101 did not show a significant difference in efficacy compared to placebo, with high discontinuation rates due to gastrointestinal side effects, particularly when combined with nintedanib. An interesting finding was that placebo-treated patients experienced a lower than anticipated decline in lung function, complicating interpretation of the experimental drug’s outcomes. We'll examine how the disappointing trial results and high discontinuation rates reshape Tvardi Therapeutics' investment narrative and future priorities. The end of cancer? These 28 emerging AI stocks are developing tech that will allow early identification of life changing diseases like cancer and Alzheimer's. To be a shareholder in Tvardi Therapeutics right now requires belief in the company’s pipeline beyond idiopathic pulmonary fibrosis (IPF), especially after the recent Phase 2 REVERT trial for TTI-101 failed to meet its goals. The sharp drop in share price reflects how material this trial’s outcome is, investors have shifted focus onto the company’s cash runway and the anticipated 2026 topline data from the TTI-101 hepatocellular carcinoma (HCC) trial. With TTI-101 for IPF no longer an imminent catalyst, the investment story now hangs on future programs and management’s ability to execute a pivot. The going concern warning in May, combined with TVRD’s small revenue and ongoing losses, puts the spotlight on funding needs and balance sheet strength. Recent events highlight how single-product failures can drastically alter risk and reward in clinical-stage biotech. However, with a sudden lack of near-term positive catalysts, the company’s cash position now takes center stage for investors. Our expertly prepared valuation report on Tvardi Therapeutics implies its share price may be too high. The Simply Wall St Community provided only one fair value estimate for Tvardi Therapeutics, showing no real spread, which suggests a lack of conviction or engagement before the latest news. Community views may diverge further now, especially as recent trial setbacks put future funding and progress in question, reminding everyone that biotech sentiment can turn quickly. Disagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd. A great starting point for your Tvardi Therapeutics research is our analysis highlighting 1 key reward and 4 important warning signs that could impact your investment decision. Our free Tvardi Therapeutics research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Tvardi Therapeutics' overall financial health at a glance. Right now could be the best entry point. These picks are fresh from our daily scans. Don't delay: Trump's oil boom is here - pipelines are primed to profit. Discover the 22 US stocks riding the wave. AI is about to change healthcare. These 33 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early. Rare earth metals are an input to most high-tech devices, military and defence systems and electric vehicles. The global race is on to secure supply of these critical minerals. Beat the pack to uncover the 36 best rare earth metal stocks of the very few that mine this essential strategic resource. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include TVRD. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

On track for multiple Phase 2 data readouts with STAT3 inhibitor, TTI-101, with lead program in IPF expected in Q4 2025 Cash runway anticipated to be sufficient to fund operations into Q4 2026 HOUSTON, August 14, 2025--(BUSINESS WIRE)--Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced its financial and operating results for the second quarter ended June 30, 2025, and provided a business update. Second Quarter 2025 Highlights: Announced completion of enrollment in its REVERT IPF clinical trial, a Phase 2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF); topline data on track for Q4 2025. Submitted an Investigational New Drug (IND) application for its second clinical candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025. Announced that an abstract, entitled Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, was presented at the American Thoracic Society (ATS) 2025 Annual Conference. Completed its merger with Cara Therapeutics, transitioning Tvardi into a publicly traded company. Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial. These data will offer important additional insights into the safety and efficacy of TTI-101, and, if positive, we believe will further validate our approach of targeting STAT3, a central mediator of fibrosis, to treat patients with IPF. "In parallel, our Phase 2 REVERT Liver Cancer trial continues to enroll patients, and we remain on track to report topline results in the first half of 2026. Prior interim data from this ongoing study demonstrated clinically meaningful activity of TTI-101 as both monotherapy and in combination with established anti-cancer agents across treatment lines. "Importantly, we are well-financed through these potential value inflection points, and into Q4 of next year. We believe we are very well positioned to bring meaningful innovation to patients living with fibrosis driven-diseases while creating significant value for our company." Upcoming Milestones: Data from the company’s ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 4Q 2025 Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026 Second Quarter 2025 Financial Results Research and development expenses for the three months ended June 30, 2025, were $5.8 million as compared to $6.5 million for the comparable period in 2024. The decrease of $0.7 million was primarily driven by clinical, pre-clinical, and CMC costs associated with TTI-101. General and administrative expenses for the three months ended June 30, 2025, were $3.1 million as compared to $650,000 for the comparable period in 2024. The increase of $2.4 million was primarily driven by increases in professional fees of $1.6 million, attributable to increased legal, accounting and audit fees incurred as a result of the merger. The remaining increase was attributable to increases in personnel costs, insurance costs, and other costs. Net income for the three months ended June 30, 2025, was $4.2 million as compared to a net loss of $7.0 million for the comparable period in 2024. The improvement in net income was due primarily to a $12.8 million remeasurement gain on Tvardi’s Convertible Notes recognized in the second quarter of 2025. Basic and diluted net income (loss) per share attributable to common shareholders for the three months ended June 30, 2025, were a net gain of $0.51 and net loss of $1.00, respectively, compared to a net loss of $2.71 on a basic and diluted basis for the comparable period in 2024. Cash, cash equivalents and short-term investments as of June 30, 2025, were $41.0 million, as compared to $31.6 million as of December 31, 2024. About Tvardi Therapeutics 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. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250814432468/en/ Contacts For Tvardi: Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors 617-430-7579 [email protected]

Completed merger with Cara Therapeutics; cash, cash equivalents and short-term investments at closing anticipated to be sufficient to fund operations into 2H 2026 On track for multiple Phase 2 data readouts with STAT3 inhibitor, TTI-101, with lead program in IPF expected in 2H 2025 HOUSTON, May 13, 2025--(BUSINESS WIRE)--Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical- stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced its financial and operating results for the first quarter ended March 31, 2025, and provided a business update. First Quarter 2025 and Subsequent Period Highlights: Tvardi completed its merger with Cara Therapeutics. Tvardi received approximately $23.8 million in net cash from Cara in connection with the closing of the merger. This capital augments the previously announced December 2024 private placement financing of approximately $28.3 million from a syndicate of new and existing institutional investors. Announced that an abstract, entitled, Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, will be presented at the upcoming American Thoracic Society 2025 Annual Conference, which is being held May 16-21, 2025 in San Francisco. Announced that results from the first-in-human Phase 1 study of TTI-101 in patients with advanced solid tumors were published in the journal Clinical Cancer Research. Dr. Imran Alibhai, Chief Executive Officer of Tvardi, stated, "While it has only been a few weeks since we completed our merger with Cara Therapeutics, our Nasdaq listing has heightened our visibility and potential access to capital. With the cash on our balance sheet, we believe we are well financed through meaningful value inflection points, including anticipated Phase 2 readouts of our lead program in idiopathic pulmonary fibrosis (IPF) as well as our hepatocellular carcinoma program. We expect that our anticipated cash runway, as of the closing of the merger, will be sufficient to fund our operations approximately one year post data readouts in IPF, into the second half of 2026." Upcoming Milestones: Investigational New Drug (IND) submission planned for its second clinical candidate, TTI- 109, in 1H 2025 Data from the company’s ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 2H 2025 Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026 About Tvardi Therapeutics 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. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter). Cautionary Statement Regarding Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward- looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the "Risk Factors" section of the Registration Statement on Form S-4, as amended (File No. 333-283900) initially filed with the Securities and Exchange Commission (the "SEC") on December 18, 2024 and declared effective by the SEC on February 14, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250513465890/en/ Contacts For Tvardi: Tvardi Investor Relations [email protected] PJ Kelleher LifeSci Advisors 617-430-7579 [email protected]