Tvardi Therapeutics, Inc.

Previous wording

Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. Based upon Tvardi’s founder’s seminal work and deep understanding of the transcription factor STAT3, Tvardi has designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, Tvardi is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. Tvardi’s lead product candidate, TTI-101, is currently in Phase 2 clinical development for the treatment of fibrosis-driven diseases, with an initial focus on idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC). Tvardi expects to report unblinded data from its Phase 2 IPF clinical trial in the fourth quarter of 2025 and anticipate preliminary topline data from its Phase 1b/2 HCC clinical trial in the first half of 2026. Tvardi’s second product candidate, TTI-109, is also an oral, small molecule STAT3 inhibitor that is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance Tvardi’s ability to target STAT3. Tvardi submitted an Investigational New Drug (IND) application for TTI-109 in June 2025.

Current wording

Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. Based upon Tvardi’s founder’s seminal work and deep understanding of the transcription factor STAT3, Tvardi has designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, Tvardi is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. Tvardi’s lead product candidate, TTI-101, is currently in Phase 2 clinical development in hepatocellular carcinoma (HCC). Tvardi expects to report preliminary topline data from its Phase 1b/2 HCC clinical trial in the first half of 2026. Tvardi’s second product candidate, TTI-109, is also an oral, small molecule STAT3 inhibitor that is structurally related to, yet chemically distinct from, TTI-101 and is designed to enhance Tvardi’s ability to target STAT3. Tvardi submitted an Investigational New Drug (IND) application for TTI-109 in June 2025. After U.S. Food and Drug Administration (FDA) acceptance of the IND, Tvardi has initiated a Phase 1 trial of TTI-109 in healthy volunteers to evaluate safety, tolerability, and pharmacokinetics, as well as bioequivalence to TTI-101. The study is ongoing and Tvardi expects to report out topline data from this trial in the first half of 2026. In October 2025, Tvardi reported preliminary data from its Phase 2 clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF) and concluded that the study did not meet its goals. Tvardi is conducting additional analyses to further understand these results and inform next steps.

Previous wording

As of June 30, 2025, Tvardi had $20.6 million in cash and cash equivalents and $20.3 million in short-term investments. As further discussed below, in April 2025, Legacy Tvardi completed its Merger (as defined below) with Cara Therapeutics, Inc. (Cara), through which Legacy Tvardi acquired approximately $23.9 million in net assets. Tvardi has incurred net losses since inception. As of June 30, 2025 and December 31, 2024, its accumulated deficit was $97.6 million and $92.2 million, respectively. For the three and six months ended June 30, 2025, Tvardi reported net income of $4.2 million and net loss of $5.4 million, respectively. For the three and six months ended June 30, 2024, Legacy Tvardi reported net losses of $7.0 million and $11.2 million, respectively. Tvardi’s net income (loss) may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of its clinical development activities and other research and development activities. Although Tvardi generated net income for the three months ended June 30, 2025 as a result of the net changes in fair value of its Convertible Notes, Tvardi expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Losses are expected to continue as Tvardi continues to invest in research and development activities. The assessment of Tvardi’s ability to meet its future obligations is inherently judgmental, subjective and susceptible to change. Given the inherent uncertainties in the forecast, Tvardi considered both quantitative and qualitative factors that are known or reasonably knowable as of the date that these condensed consolidated financial statements are issued and concluded that there are conditions present in the aggregate that raise substantial doubt about Tvardi’s ability to continue as a going concern. Tvardi has based this estimate on assumptions that may prove to be wrong, and it could exhaust its capital resources as of June 30, 2025 sooner than it expects. See the subsection titled “—Liquidity and Capital Resources” below for further discussion .

Current wording

As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments. As further discussed below, in April 2025, Legacy Tvardi completed its Merger (as defined below) with Cara Therapeutics, Inc. (Cara), through which Legacy Tvardi acquired approximately $23.9 million in net assets. Tvardi has incurred net losses since inception. As of September 30, 2025 and December 31, 2024, its accumulated deficit was $103.2 million and $92.2 million, respectively. For the three and nine months ended September 30, 2025, Tvardi reported net losses of $5.5 million and $10.9 million, respectively. For the three and nine months ended September 30, 2024, Legacy Tvardi reported net losses of $5.5 million and $16.7 million, respectively. Tvardi’s net loss may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of its clinical development activities and other research and development activities. Tvardi expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Losses are expected to continue as Tvardi continues to invest in research and development activities. The assessment of Tvardi’s ability to meet its future obligations is inherently judgmental, subjective and susceptible to change. Given the inherent uncertainties in the forecast, Tvardi considered both quantitative and qualitative factors that are known or reasonably knowable as of the date that these condensed consolidated financial statements are issued and concluded that there are conditions present in the aggregate that raise substantial doubt about Tvardi’s ability to continue as a going concern. Tvardi has based this estimate on assumptions

Previous wording

Given Tvardi’s stage of development, to date it has not had any products approved for sale and has not generated any revenue. Tvardi does not expect to generate any revenues from product sales unless and until it successfully completes development and obtains regulatory approval for one or more of its product candidates, which may not be for several years, if ever. If Tvardi obtains regulatory approval for any of its product candidates, it expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that Tvardi can generate substantial product revenue, it expects to finance its cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, Tvardi may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. If Tvardi does raise additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If Tvardi raises additional capital through debt financing, it may be subject to covenants or other restrictions limiting its ability to engage in specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on its financial condition and on its ability to pursue its business plans and strategies, including its research and development activities. If Tvardi is unable to raise capital, Tvardi will need to delay, reduce or terminate planned activities, including its ongoing and planned clinical trials, to reduce costs.

Current wording

Given Tvardi’s stage of development, to date it has not had any products approved for sale and has not generated any revenue. Tvardi does not expect to generate any revenues from product sales unless and until it successfully completes development and obtains regulatory approval for one or more of its product candidates, which may not be for several years, if ever. If Tvardi obtains regulatory approval for any of its product candidates, it expects to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that Tvardi can generate substantial product revenue, it expects to finance its cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, Tvardi may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. If Tvardi does raise additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If Tvardi raises additional capital through debt financing, it may be subject to covenants or other restrictions limiting its ability to engage in specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on its financial condition and on its ability to pursue its business plans and strategies, including its

Previous wording

Additionally, Tvardi is subject to risks and uncertainties as of result of global business, political and macroeconomic events and conditions, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling and potential government shutdowns related thereto, potential instability in the global banking system, cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics. Tvardi’s business, financial condition and results of operations could be materially and adversely affected by further negative impact on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.

Current wording

Additionally, Tvardi is subject to risks and uncertainties as of result of global business, political and macroeconomic events and conditions, including increasing financial market volatility and uncertainty, inflation, interest rate fluctuations, uncertainty with respect to the federal budget and debt ceiling, as well as the potential for future potential government shutdowns related thereto, potential instability in the global banking system, cybersecurity events, the impact of war or military conflict, including regional conflicts around the world, and public health pandemics. Tvardi’s business, financial condition and results of operations could be materially and adversely affected by further negative impact on the global economy and capital markets resulting from these global economic conditions, particularly if such conditions are prolonged or worsen.

Previous wording

On December 17, 2024, Legacy Tvardi entered into an agreement and plan of merger and reorganization (the Merger Agreement) with Cara and CT Convergence Merger Sub, Inc., a wholly-owned subsidiary of Cara (Merger Sub), pursuant to which, on April 15 2025, Merger Sub merged with and into Legacy Tvardi, with Legacy Tvardi surviving as a wholly-owned subsidiary of Cara (the Merger). Upon completion of the Merger, Cara changed its name to Tvardi Therapeutics, Inc., and Legacy Tvardi’s business will continue as the business of Tvardi.

Current wording

On December 17, 2024, Legacy Tvardi entered into an agreement and plan of merger and reorganization (the Merger Agreement) with Cara and CT Convergence Merger Sub, Inc., a wholly-owned subsidiary of Cara (Merger Sub), pursuant to which, on April 15, 2025, Merger Sub merged with and into Legacy Tvardi, with Legacy Tvardi surviving as a wholly-owned subsidiary of Cara (the Merger). Upon completion of the Merger, Cara changed its name to Tvardi Therapeutics, Inc., and Legacy Tvardi’s business continued as the business of Tvardi.

Previous wording

Immediately following the Merger, equity holders of Legacy Tvardi prior to the Merger, including the holders of Convertible Notes, owned approximately 84.5% of the outstanding common stock of Tvardi on a fully diluted basis.

Current wording

Immediately following the Merger, equity holders of Legacy Tvardi prior to the Merger, including the holders of Convertible Notes, owned approximately 84.5% of the outstanding Tvardi common stock on a fully diluted basis.

Previous wording

As of the Effective Time, there were 935,554 and 93,555 shares of Tvardi’s common stock available for grant under the 2025 Plan and 2025 ESPP, respectively. As of June 30, 2025, there was 537,614 shares of Tvardi’s common stock remaining available for grant under the 2025 Plan. As of June 30, 2025, no offering periods under the 2025 ESPP had been initiated.

Current wording

As of the Effective Time, there were 935,554 and 93,555 shares of Tvardi’s common stock available for grant under the 2025 Plan and 2025 ESPP, respectively. As of September 30, 2025, there was 551,221 shares of Tvardi’s common stock remaining available for grant under the 2025 Plan. As of September 30, 2025, no offering periods under the 2025 ESPP had been initiated.

Previous wording

Upon the closing of the Merger, pursuant to the terms of the Convertible Notes, the outstanding principal balance of the Convertible Notes and all unpaid accrued interest automatically converted into 1,265,757 shares of Tvardi common stock in the aggregate. Utilizing the fair value option to account for the Convertible Notes, Tvardi recorded a gain of $12.8 million and a net gain of $7.8 million in its condensed consolidated statements of operations and comprehensive income (loss) for the three and six months ended June 30, 2025, respectively, as a result of the net changes in fair value.

Current wording

Upon the closing of the Merger, pursuant to the terms of the Convertible Notes, the outstanding principal balance of the Convertible Notes and all unpaid accrued interest automatically converted into 1,265,757 shares of Tvardi common stock in the aggregate. Utilizing the fair value option to account for the Convertible Notes, Tvardi recorded a gain of $12.8 million during the second quarter of 2025 and a net gain of $7.8 million for the nine months ended September 30, 2025 in its condensed consolidated statements of operations and comprehensive loss as a result of the net changes in fair value over the year-to-date 2025 period. There was no change in fair value recorded during the three months ended September 30, 2025 as the Convertible Notes were fully converted during the second quarter of 2025.

Previous wording

Under the BCM First Agreement, Legacy Tvardi obtained an exclusive, worldwide, sublicensable license under BCM’s rights to certain patents and patent applications related to STAT3 inhibitors in oncology and certain non-oncology indications, which Tvardi refers to as the BCM Patent Rights, together with certain cell lines, biological materials, compounds, know-how and technologies, which Tvardi collectively refers to as the BCM Technology, to make, have made, use, market, sell, offer to sell, lease and import BCM1 Licensed Products, in all fields of use.

Current wording

Under the BCM First Agreement, Legacy Tvardi obtained an exclusive, worldwide, sublicensable license under BCM’s rights to certain patents and patent applications related to STAT3 inhibitors in oncology and certain non-oncology indications, which Tvardi refers to as the BCM Patent Rights, together with certain cell lines, biological

Previous wording

Pursuant to the terms of the BCM First Agreement, StemMed owed an initial license fee of $75,000 as consideration for the license rights. Upon the assignment of the agreement to Legacy Tvardi, Legacy Tvardi became responsible for the payment of annual maintenance fees on the anniversary of the agreement, which range from $30,000 to $50,000. Tvardi is also required to pay BCM royalties in the amount of a low-single-digit percent of net sales of BCM1 Licensed Products during the term, which expires, on a country-by-country basis, on the later of (i) the date of expiration of the last-to-expire of the BCM Patent Rights, or, (ii) if no BCM Patent Rights issued in such country, the tenth anniversary of the first commercial sale of the BCM1 Licensed Product in such country. Tvardi currently expects the BCM Patent Rights to expire April 18, 2039. Upon the initiation of the Phase 2 clinical trials for two BCM1 Licensed Products, Legacy Tvardi paid BCM development milestone payments of $250,000 in the aggregate. Upon the achievement of additional specified development and regulatory milestones, Tvardi is required to pay BCM one-time milestone payments of up to $2,200,000 in the aggregate for the first BCM1 Licensed Product in an oncology indication and for the first BCM1 Licensed Product in a non-oncology indication to achieve such milestones. Further, in connection with the initiation of the Phase 3 clinical trial, Tvardi would expect to incur approximately $400,000 of oncology-related costs and approximately $300,000 of non-oncology-related costs. Tvardi is additionally required to pay BCM a tiered low-

Current wording

Pursuant to the terms of the BCM First Agreement, StemMed owed an initial license fee of $75,000 as consideration for the license rights. Upon the assignment of the agreement to Legacy Tvardi, Legacy Tvardi became responsible for the payment of annual maintenance fees on the anniversary of the agreement, which range from $30,000 to $50,000. Tvardi is also required to pay BCM royalties in the amount of a low-single-digit percent of net sales of BCM1 Licensed Products during the term, which expires, on a country-by-country basis, on the later of (i) the date of expiration of the last-to-expire of the BCM Patent Rights, or, (ii) if no BCM Patent Rights issued in such country, the tenth anniversary of the first commercial sale of the BCM1 Licensed Product in such country. Tvardi currently expects the BCM Patent Rights to expire April 18, 2039. Upon the initiation of the Phase 2 clinical trials for two BCM1 Licensed Products, Legacy Tvardi paid BCM development milestone payments of $250,000 in the aggregate. Upon the achievement of additional specified development and regulatory milestones, Tvardi is required to pay BCM one-time milestone payments of up to $2,200,000 in the aggregate for the first BCM1 Licensed Product in an oncology indication and for the first BCM1 Licensed Product in a non-oncology indication to achieve such milestones. Further, in connection with the initiation of the Phase 3 clinical trial, Tvardi would expect to incur approximately $400,000 of oncology-related costs and approximately $300,000 of non-oncology-related costs. Tvardi is additionally required to pay BCM a tiered low-double-digit percentage of sublicensing revenue obtained in connection with any sublicense granted by Tvardi under the BCM Patent Rights or BCM Technology.

Previous wording

Under the BCM First Agreement, the full amount of $50,000 in annual maintenance fees had already been paid as of June 30, 2025, and thus no accrual was needed. As a result, Tvardi recorded $25,000 in prepaid expenses as of June 30, 2025. As of December 31, 2024, the full amount of $50,000 in annual maintenance fees had already been paid and thus no accrual was needed. No royalty fees have been incurred to date. All related license costs are expensed as incurred within research and development on the condensed consolidated statements of operations and comprehensive income (loss).

Current wording

Under the BCM First Agreement, the full amount of $50,000 in annual maintenance fees had already been paid as of September 30, 2025, and thus no accrual was needed. As a result, Tvardi had $12,500 remaining in prepaid expenses as of September 30, 2025. As of December 31, 2024, the full amount of $50,000 in annual maintenance fees had already been paid and thus no accrual was needed. No royalty fees have been incurred to date. All related license costs are expensed as incurred within research and development on the condensed consolidated statements of operations and comprehensive loss.

Previous wording

Pursuant to the terms of the BCM Second Agreement, StemMed owed an initial license fee of $5,000 in consideration for the license rights. Upon the assignment of the agreement to Legacy Tvardi, it became responsible for the payment of maintenance fees on the anniversary of the agreement, which range from $30,000 to $50,000. Tvardi is also required to pay BCM royalties in the amount of a low-single-digit percent of net sales of BCM2 Licensed Products during the term, which expires, on a country-by-country basis, on the later (i) of the date of expiration of the last to expire of the Licensed Patent Rights, or, (ii) if no Licensed Patent Rights issued in such country, the tenth anniversary of the first commercial sale of the BCM2 Licensed Product in such country. Tvardi currently expects the Licensed Patent Rights to expire July 18, 2034. Upon the achievement of additional specified development and regulatory milestones, Tvardi is required to pay BCM one-time milestone payments of up to $1,225,000 in the aggregate for the first BCM2 Licensed Product to achieve such milestones. Further, in connection with the initiation of the Phase 3 clinical trial, Tvardi would expect to incur approximately $300,000 in costs. Tvardi is additionally required to pay BCM a tiered low-double-digit percentage of sublicensing revenue obtained in connection with any sublicense granted by Tvardi under the Licensed Patent Rights.

Current wording

Pursuant to the terms of the BCM Second Agreement, StemMed owed an initial license fee of $5,000 in consideration for the license rights. Upon the assignment of the agreement to Legacy Tvardi, it became responsible for the payment of maintenance fees on the anniversary of the agreement, which range from $30,000 to $50,000. Tvardi is also required to pay BCM royalties in the amount of a low-single-digit percent of net sales of BCM2 Licensed Products during the term, which expires, on a country-by-country basis, on the later (i) of the date of expiration of the last to expire of the Licensed Patent Rights, or, (ii) if no Licensed Patent Rights issued in such country, the tenth anniversary of the first commercial sale of the BCM2 Licensed Product in such country. Tvardi currently expects the Licensed Patent Rights to expire July 18, 2034. Upon the achievement of additional specified development and regulatory milestones, Tvardi is required to pay BCM one-time milestone payments of up to $1,225,000 in the aggregate for the first BCM2

Previous wording

Under the BCM Second Agreement, no payments were made or incurred during the three and six months ended June 30, 2025 and 2024. No royalty fees have been incurred to date.

Current wording

Under the BCM Second Agreement, no payments were made or incurred during the three and nine months ended September 30, 2025 and 2024. No royalty fees have been incurred to date.

Previous wording

The majority of Tvardi’s clinical spending in the three and six months ended June 30, 2025 and Legacy Tvardi’s clinical spending in the three and six months ended June 30, 2024 was on TTI-101, for which certain direct research and development costs are tracked by clinical trial. Spending for the development of TTI-109 primarily began in 2023 and all costs incurred for TTI-109 for the three and six months ended June 30, 2025 and 2024 are related to chemistry, manufacturing and control (CMC) costs as well as pre-clinical costs.

Current wording

The majority of Tvardi’s clinical spending in the three and nine months ended September 30, 2025 and Legacy Tvardi’s clinical spending in the three and nine months ended September 30, 2024 was on TTI-101, for which certain direct research and development costs are tracked by clinical trial. Spending for the development of TTI-109 began in 2023 and costs incurred for TTI-109 related to chemistry, manufacturing and control (CMC) and clinical operations for the three and nine months ended September 30, 2025, and CMC and pre-clinical operations for the three and nine months ended September 30, 2024.

Previous wording

Interest income for the three and six months ended June 30, 2025 consisted of interest earned on Tvardi’s cash equivalents as well as interest earned on short-term investments and the accretion of the discount of its short-term investments. Interest income for the three and six months ended June 30, 2024 consisted of interest earned on Legacy Tvardi’s cash equivalents.

Current wording

Interest income for the three and nine months ended September 30, 2025 consisted of interest earned on Tvardi’s cash equivalents as well as interest earned on short-term investments and the accretion of the discount of its short-term investments. Interest income for the three and nine months ended September 30, 2024 consisted of interest earned on Legacy Tvardi’s cash equivalents.

Previous wording

For the three and six months ended June 30, 2025 and 2024, there was no current or deferred income tax expense or benefit due to Tvardi’s current year losses and full valuation allowance. As of June 30, 2025, Tvardi evaluated all available evidence and concluded that a valuation allowance is still required against its net deferred tax assets because it is more likely than not they will not be realized in the foreseeable future.

Current wording

For the three and nine months ended September 30, 2025 and 2024, there was no current or deferred income tax expense or benefit due to Tvardi’s current year losses and full valuation allowance. As of September 30, 2025, Tvardi evaluated all available evidence and concluded that a valuation allowance is still required against its net deferred tax assets because it is more likely than not they will not be realized in the foreseeable future.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Current wording

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024

Previous wording

The following table sets forth Tvardi’s results of operations for the three and six months ended June 30, 2025 and 2024 (in thousands, except percentages):

Current wording

The following table sets forth Tvardi’s results of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Previous wording

Research and development expenses for the three and six months ended June 30, 2025 and 2024 were comprised of the following (in thousands, except percentages):

Current wording

Research and development expenses for the three and nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands, except percentages):

Previous wording

Research and development expenses were $5.8 million for the three months ended June 30, 2025, compared to $6.5 million for the three months ended June 30, 2024. The decrease of $0.7 million was primarily driven by costs associated with Tvardi’s product candidate TTI-101, including decreases of $0.6 million and $2.1 million related to Tvardi’s HCC trial and metastatic breast cancer (mBC) trial, respectively, as well as a $0.1 million decrease in pre-clinical CMC costs. The decrease in Tvardi’s HCC trial was attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s mBC trial was due to the discontinuation of the trial in January 2024 and a related true-up recorded during the three months ended June 30, 2025 due to the negotiation of wind-down costs. These decreases in

Current wording

Research and development expenses were $3.6 million for the three months ended September 30, 2025, compared to $4.8 million for the three months ended September 30, 2024. The decrease of $1.2 million was primarily driven by costs associated with Tvardi’s product candidate TTI-101, including decreases of $1.4 million, $1.0 million and $0.7 million related to Tvardi’s HCC, IPF and metastatic breast cancer (mBC) trials, respectively. The decrease in Tvardi’s HCC trial was primarily attributable to the changes in patient enrollments and estimated study costs. The decrease in Tvardi’s IPF trial was attributable to the trial being completed in the second quarter of 2025, with no additional expenses expected to be incurred until the fourth quarter of 2025. The decrease in Tvardi’s mBC trial was due to the discontinuation of the trial in January 2024.

Previous wording

The increase of $0.4 million related to Tvardi’s product candidate TTI-109 was primarily related to CMC costs of the molecule.

Current wording

The increase of $2.0 million related to Tvardi’s product candidate TTI-109 was primarily driven by the healthy volunteer study, which began in the third quarter of 2025, as well as related CMC costs.

Previous wording

Research and development expenses were $8.9 million for the six months ended June 30, 2025, compared to $10.3 million for the six months ended June 30, 2024. The decrease of $1.3 million was primarily driven by costs associated with Tvardi’s product candidate TTI-101, including decreases of $1.6 million and $2.4 million related to Tvardi’s HCC trial and mBC trial, respectively, as well as a $0.3 million decrease in pre-clinical CMC costs. The decrease in Tvardi’s HCC trial was attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s mBC trial was due to the discontinuation of the trial in January 2024 and a related true-up recorded during the three months ended June 30, 2025 due to the negotiation of wind-down costs. These decreases in costs were partially offset by a $1.9 million increase in costs related to Tvardi’s IPF trial, due to the timing of patient enrollment. As of June 30, 2025, the IPF trial is fully enrolled.

Current wording

Research and development expenses were $12.5 million for the nine months ended September 30, 2025, compared to $15.0 million for the nine months ended September 30, 2024. The decrease of $2.5 million was primarily driven by costs associated with Tvardi’s product candidate TTI-101, including decreases of $3.0 million and $3.0 million related to Tvardi’s HCC and mBC trials, respectively. The decrease in Tvardi’s HCC trial was attributable to the changes in patient enrollments and estimated study costs, while the decrease in Tvardi’s mBC trial was due to the discontinuation of the trial in January 2024 and a related true-up recorded during the second quarter of 2025 due to the negotiation of wind-down costs. These decreases in costs were partially offset by a $0.9 million increase in costs related to Tvardi’s IPF trial, due to the timing of patient enrollment prior to the trial ending in the second quarter of 2025.

Previous wording

The increase of $0.5 million related to Tvardi’s product candidate TTI-109 was primarily related to CMC costs of the molecule.

Current wording

The increase of $2.5 million related to Tvardi’s product candidate TTI-109 was primarily driven by the healthy volunteer study, which began in the third quarter of 2025, as well as related CMC costs.

Previous wording

The increase of personnel costs of $0.2 million was primarily related to increases in compensation across the research and development functions. The $0.1 million increase in consultant fees and other costs was primarily related to other research and development costs such as costs to maintain intellectual property and prepare regulatory filings.

Current wording

The increase of personnel costs of $0.2 million was primarily related to increases in compensation across the research and development functions. The $0.2 million increase in consultant fees and other costs was primarily related to other research and development costs such as costs to maintain intellectual property and prepare regulatory filings.

Previous wording

General and administrative expenses for the three and six months ended June 30, 2025 and 2024 were comprised of the following (in thousands, except percentages):

Current wording

General and administrative expenses for the three and nine months ended September 30, 2025 and 2024 were comprised of the following (in thousands, except percentages):

Previous wording

General and administrative expenses were $4.3 million for the six months ended June 30, 2025, compared to $1.4 million for the six months ended June 30, 2024. The increase of $2.9 million was primarily driven by increases in professional fees of $2.0 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 rent and other related costs.

Current wording

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 increased legal fees and ongoing accounting and audit fees. The remaining increase was attributable to increases in personnel costs, insurance costs, and rent and other related costs.

Previous wording

General and administrative expenses were $3.1 million for the three months ended June 30, 2025, compared to $0.7 million for the three months ended June 30, 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 rent and other related costs.

Current wording

General and administrative expenses were $6.6 million for the nine months ended September 30, 2025, compared to $2.3 million for the nine months ended September 30, 2024. The increase of approximately $4.4 million was primarily driven by increases in professional fees of $2.7 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 rent and other related costs.

Previous wording

Interest income was $0.4 million for the three months ended June 30, 2025, compared to $0.2 million for the three months ended June 30, 2024. The $0.4 million of interest income for the three months ended June 30, 2025 includes $0.1 million of interest earned on Tvardi’s cash and cash equivalents and $0.3 million of interest from its short-term investments, as well as the accretion of the discount on its short-term investments. The $0.2 million of interest income for the three months ended June 30, 2024 was driven by interest income earned on Legacy Tvardi’s cash equivalents.

Current wording

Interest income was $0.4 million for the three months ended September 30, 2025, compared to $0.2 million for the three months ended September 30, 2024. The $0.4 million of interest income for the three months ended September 30, 2025 includes $0.3 million of interest earned on Tvardi’s cash and cash equivalents and $0.1 million of interest from its short-term investments, as well as the accretion of the discount on its short-term investments. The $0.2 million of interest income for the three months ended September 30, 2024 was driven by interest income earned on Legacy Tvardi’s cash equivalents.

Previous wording

Interest income was $0.7 million for the six months ended June 30, 2025, compared to $0.5 million for the six months ended June 30, 2024. The $0.7 million of interest income for the six months ended June 30, 2025 includes $0.3 million of interest earned on Tvardi’s cash and cash equivalents and $0.4 million of interest from its short-term investments, as well as the accretion of the discount on its short-term investments. The $0.5 million of interest income for the six months ended June 30, 2024 was driven by interest income earned on Legacy Tvardi’s cash equivalents.

Current wording

Interest income was $1.1 million for the nine months ended September 30, 2025, compared to $0.6 million for the nine months ended September 30, 2024. The $1.1 million of interest income for the nine months ended September 30, 2025 includes $0.6 million of interest earned on Tvardi’s cash and cash equivalents and $0.5 million of interest from its short-term investments, as well as the accretion of the discount on its short-term investments. The $0.6 million of interest income for the nine months ended September 30, 2024 was driven by interest income earned on Legacy Tvardi’s cash equivalents.

Previous wording

Other income, net of $7.2 million for the six months ended June 30, 2025 was primarily attributable to the $12.8 million remeasurement gain on Legacy Tvardi’s Convertible Notes recorded during the three months ended June 30, 2025, partially offset by a $4.9 million remeasurement loss recorded during the first quarter of 2025, as well as $0.7 million in interest accrued on the Convertible Notes during the six months ended June 30, 2025. The calculation for the remeasurement gain during the three months ended June 30, 2025 is further discussed above. There were no financial instruments requiring valuation or interest expense for the six months ended June 30, 2024.

Current wording

Other income, net of $7.2 million for the nine months ended September 30, 2025 was primarily attributable to the $12.8 million remeasurement gain on Legacy Tvardi’s Convertible Notes recorded during the second quarter of 2025, partially offset by a $4.9 million remeasurement loss recorded during the first quarter of 2025, as well as $0.7 million in interest accrued on the Convertible Notes during those respective periods. See “—Recent Developments” above for

Previous wording

Other income, net of $12.7 million for the three months ended June 30, 2025 was primarily attributable to a $12.8 million remeasurement gain on Legacy Tvardi’s Convertible Notes, for which Legacy Tvardi elected the fair value option, partially offset by $0.1 million in interest accrued on the Convertible Notes during the three months ended June 30, 2025. At the time of conversion, as further discussed within the “—Recent Developments—Convertible Notes” section above, the fair value of the Convertible Notes was $23.1 million, calculated as 1,265,757 shares of common stock at the closing market trading price on April 16, 2025. The $12.8 million change in fair value was calculated by comparing the $23.1 million at the time of conversion to the $35.9 million recorded value of the Convertible Notes immediately prior to the conversion date. There were no financial instruments requiring valuation or interest expense for the three months ended June 30, 2024.

Current wording

further discussion of the Convertible Notes. There were no financial instruments requiring valuation or interest expense for the nine months ended September 30, 2024.

Previous wording

Since inception, Legacy Tvardi has not generated any revenue from product sales or any other sources and has incurred significant operating losses. Legacy Tvardi has not yet commercialized any products and Tvardi does not expect to generate revenue from sales of any product candidates for several years, if ever. To date, Legacy Tvardi has financed its operations primarily through the (i) issuance and sale of its Convertible Notes in December 2024 for gross proceeds of $28.3 million (ii) the issuance and sale of preferred stock and historical convertible debt (which converted into preferred stock in 2018 and 2021) for total gross proceeds of $83.4 million, and (iii) as discussed above in “—Recent Developments,” its Merger with Cara in April 2025. To date, Legacy Tvardi has devoted substantially all of its efforts and financial resources to developing its product candidates, organizing and staffing its company, business planning, raising capital, establishing its intellectual property portfolio and performing research and development of its product candidates, signaling and biology, medicinal chemistry and clinical insights to discover and develop novel therapies for the treatment of fibrosis-driven diseases. As of June 30, 2025, Tvardi had $20.6 million in cash and cash equivalents and $20.3 million in short-term investments. In April 2025, Legacy Tvardi acquired approximately $23.9 million of net assets in connection with the closing of the Merger.

Current wording

Since inception, Tvardi has not generated any revenue from product sales or any other sources and has incurred significant operating losses. Tvardi has not yet commercialized any products and does not expect to generate revenue from sales of any product candidates for several years, if ever. To date, Tvardi has financed its operations primarily through the (i) issuance and sale of its Convertible Notes in December 2024 for gross proceeds of $28.3 million (ii) the issuance and sale of preferred stock and historical convertible debt (which converted into preferred stock in 2018 and 2021) for total gross proceeds of $83.4 million, and (iii) as discussed above in “—Recent Developments,” its Merger with Cara in April 2025. To date, Tvardi has devoted substantially all of its efforts and financial resources to developing its product candidates, organizing and staffing its company, business planning, raising capital, establishing its intellectual property portfolio and performing research and development of its product candidates, signaling and biology, medicinal chemistry and clinical insights to discover and develop novel therapies for the treatment of fibrosis-driven diseases. As of September 30, 2025, Tvardi had $21.4 million in cash and cash equivalents and $15.0 million in short-term investments. In April 2025, Tvardi acquired approximately $23.9 million of net assets in connection with the closing of the Merger.

Previous wording

Tvardi’s primary uses of cash are to fund its operations, which consist primarily of research and development costs related to the development of its product candidates, and, to a lesser extent, general and administrative costs. Legacy Tvardi has incurred significant operating losses since its inception, and as of June 30, 2025, had an accumulated deficit of $97.6 million. Management has determined that its present capital resources as of June 30, 2025 will not be sufficient to fund its planned operations for at least one year from the issuance date of the unaudited condensed consolidated financial statements, included elsewhere in this Quarterly Report, which raises substantial doubt as to Tvardi’s ability to continue as a going concern. In April 2025, as further discussed above, Legacy Tvardi completed its Merger with Cara, through which it acquired approximately $23.9 million in net assets. Subsequent to the completion of the Merger, Tvardi plans to seek additional funding through equity offerings or debt financings, credit or loan facilities, and strategic alliances and licensing arrangements. However, there can be no assurance that such funding will be available to Tvardi, will be obtained on terms favorable to Tvardi, or will provide Tvardi with sufficient funds to meet its objectives.

Current wording

Tvardi’s primary uses of cash are to fund its operations, which consist primarily of research and development costs related to the development of its product candidates, and, to a lesser extent, general and administrative costs. Tvardi has incurred significant operating losses since its inception, and as of September 30, 2025, had an accumulated deficit of $103.2 million. Management has determined that its present capital resources as of September 30, 2025 will not be sufficient to fund its planned operations for at least one year from the issuance date of the unaudited condensed consolidated financial statements, included elsewhere in this Quarterly Report, which raises substantial doubt as to Tvardi’s ability to continue as a going concern. In April 2025, as further discussed above, Legacy Tvardi completed its Merger with Cara, through which it acquired approximately $23.9 million in net assets. Subsequent to the completion of the Merger, Tvardi plans to seek additional funding through equity offerings or debt financings, credit or loan facilities, and strategic alliances and licensing arrangements. However, there can be no assurance that such funding will be available to Tvardi, will be obtained on terms favorable to Tvardi, or will provide Tvardi with sufficient funds to meet its objectives.

Previous wording

Tvardi anticipates that it will continue to incur significant and increasing expenses for the foreseeable future as it continues to advance its product candidates, expand its corporate infrastructure, including the costs associated with being a public company following the Merger, further Tvardi’s research and development initiatives for its product candidates and incur costs associated with the potential commercialization of its product candidates, if approved. Tvardi is subject to all of the risks typically related to the development of new drug candidates, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. Tvardi anticipates that it will need substantial additional funding in connection with its continuing operations. However, Tvardi may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If Tvardi raises additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If Tvardi raises additional capital through debt financing, it may be subject to covenants or other restrictions limiting its ability to engage in specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on Tvardi’s financial condition and on its ability to pursue its business plans and strategies. If Tvardi is unable to raise capital, it will need to delay, reduce or terminate planned activities to reduce costs.

Current wording

Tvardi anticipates that it will continue to incur significant and potentially increasing expenses for the foreseeable future as it continues to advance its product candidates, expand its corporate infrastructure, including the costs associated with being a public company following the Merger, further Tvardi’s research and development initiatives for its product candidates and incur costs associated with the potential commercialization of its product candidates, if approved. Tvardi is subject to all of the risks typically related to the development of new drug candidates, and may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. Tvardi anticipates that it will need substantial additional funding in connection with its continuing operations. However, Tvardi may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. If Tvardi raises additional capital through public or private equity offerings, the ownership interest of its existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect its stockholders’ rights. If Tvardi raises additional capital through debt financing, it may be subject to covenants or other restrictions limiting its ability to engage in specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Any failure to raise capital as and when needed could have a negative impact on Tvardi’s financial condition and on its ability to pursue its business plans and strategies. If Tvardi is unable to raise capital, it will need to delay, reduce or terminate planned activities to reduce costs.

Previous wording

Net cash used in operating activities was $13.6 million for the six months ended June 30, 2025, reflecting a net loss of $5.4 million, non-cash changes of $6.5 million, and changes in operating assets and liabilities of $1.6 million. The changes of $6.5 million in non-cash expenses were primarily driven by $7.8 million related to the net change in fair value of Legacy Tvardi’s Convertible Notes, partially offset by $0.7 million related to stock-based compensation expense and $0.7 million in interest accrued on its Convertible Notes during the six months ended June 30, 2025. The net changes in operating assets and liabilities of $1.6 million were primarily driven by a $1.7 million increase in prepaid expenses and other current assets, attributable to payments for pre-clinical activities and prepaid insurance, partially offset by a $0.1 million increase in accounts payable and accrued expenses, driven by the timing of invoices and payments.

Current wording

Net cash used in operating activities was $17.8 million for the nine months ended September 30, 2025, reflecting a net loss of $10.9 million, non-cash changes of $6.2 million, and changes in operating assets and liabilities of $0.7 million. The changes of $6.2 million in non-cash expenses were primarily driven by $7.8 million related to the net change in fair value of Legacy Tvardi’s Convertible Notes, partially offset by $1.0 million related to stock-based compensation expense and $0.7 million in interest accrued on its Convertible Notes until conversion during the second quarter of 2025. The net changes in operating assets and liabilities of $0.7 million were primarily driven by a $1.6 million increase in prepaid expenses and other current assets, attributable to payments for pre-clinical activities and prepaid insurance, partially offset by a $0.9 million increase in accounts payable and accrued expenses, driven by the timing of invoices and payments.

Previous wording

Net cash used in operating activities was $6.8 million for the six months ended June 30, 2024, reflecting a net loss of $11.2 million, partially offset by net changes in operating assets and liabilities of $4.1 million and non-cash changes for depreciation and amortization, stock-based compensation expense, and non-cash lease expense of $0.2 million. The net changes in operating assets and liabilities of $4.1 million were primarily driven by (i) a $2.6 million increase in accounts payable and accrued expenses, driven by the timing of invoices and payments, and (ii) a $1.6 million decrease in prepaid expenses and other current assets, attributable to the timing of patient enrollments.

Current wording

Net cash used in operating activities was $13.5 million for the nine months ended September 30, 2024, reflecting a net loss of $16.7 million and net changes in operating assets and liabilities of $2.8 million, partially offset by non-cash charges for depreciation and amortization, stock-based compensation expense, and non-cash lease expense of $0.4 million. The net change in operating assets and liabilities of $2.8 million was primarily driven by (i) a $2.0 million decrease in prepaid expenses and other current assets, attributable to the timing of patient enrollments, and (ii) a $0.9 million increase in accounts payable and accrued expenses, driven by the timing of invoices and payments.

Previous wording

Net cash used in investing activities was $20.4 million for the six months ended June 30, 2025, attributable to purchases of short-term investments of $31.5 million, partially offset by maturities of short-term investments of $11.1 million.

Current wording

Net cash used in investing activities was $15.1 million for the nine months ended September 30, 2025, attributable to purchases of short-term investments of $31.5 million, partially offset by maturities of short-term investments of $16.4 million.

Previous wording

There was no net cash provided by investing activities for the six months ended June 30, 2024.

Current wording

There was no net cash provided by investing activities for the nine months ended September 30, 2024.

Previous wording

The net cash used in financing activities for the six months ended June 30, 2025 was primarily due to approximately $25.0 million of cash acquired in connection with the Merger and proceeds of $0.4 million from the exercise of stock options, partially offset by payments of $2.4 million related to Merger transaction costs.

Current wording

The net cash provided by financing activities for the nine months ended September 30, 2025 was primarily due to approximately $25.0 million of cash acquired in connection with the Merger and proceeds of $0.5 million from the exercise of stock options, partially offset by payments of $2.8 million related to Merger transaction costs.

Previous wording

The immaterial net cash provided by financing activities for the six months ended June 30, 2024 was due to proceeds from the exercise of stock options.

Current wording

The net cash used in financing activities for the nine months ended September 30, 2024 was due to the payments of deferred offering costs, partially offset by proceeds from the exercise of stock options.