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Tvardi Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 14, 2026.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 14, 2026

TVRD$1.41+47.2%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements

(Unaudited)

**1.**Nature of the Business and Basis of Presentation

Tvardi Therapeutics, Inc. and its subsidiaries (Tvardi or the Company) is a Delaware corporation headquartered in Houston, Texas. The Company is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting Signal Transducer and Activator of Transcription 3 (STAT3) to treat inflammatory and proliferative diseases with significant unmet need. Based upon its founders’ seminal work and deep understanding of the transcription factor STAT3, the Company has designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, the Company is developing a pipeline of STAT3 inhibitors with a differentiated mechanism of action and convenient oral dosing. The Company’s pipeline includes two oral, small molecule STAT3 inhibitors: TTI-101 and TTI-109. TTI-101 is the Company’s first-generation direct STAT3 inhibitor, currently in Phase 1b/2 clinical development in hepatocellular carcinoma (HCC). TTI-109 is a phosphate prodrug of TTI-101 that is mechanistically identical to its parent molecule but is designed to enhance systemic drug delivery and improve tolerability. The Company submitted an Investigational New Drug (IND) application for TTI-109 in June 2025. In July 2026, the Company reported positive results from its Phase 1 clinical trial of TTI-109 in healthy volunteers evaluating safety, tolerability, pharmacokinetics and bioequivalence to TTI-101. Later in July 2026, the Company announced that it had selected ulcerative colitis (UC) as the initial disease indication for TTI-109.

Merger

On December 17, 2024, the Delaware corporation formerly known as Tvardi Therapeutics, Inc. (Legacy Tvardi) entered into an agreement and plan of merger and reorganization (the Merger Agreement) with Cara Therapeutics, Inc. (Cara), and CT Convergence Merger Sub, Inc., a wholly-owned subsidiary of Cara (Merger Sub), pursuant to which Merger Sub merged with and into Legacy Tvardi, with Legacy Tvardi surviving the merger as a wholly-owned subsidiary of Cara (such transaction, the Merger). Upon the closing of the Merger on April 15, 2025, Cara changed its corporate name to Tvardi Therapeutics, Inc. and Legacy Tvardi’s business continued as the business of the Company. Unless otherwise indicated or the context otherwise requires, references in these notes to condensed consolidated financial statements to “Tvardi” and “the Company” refer to the business and operations of Legacy Tvardi prior to the Merger and to Tvardi Therapeutics, Inc. and its consolidated subsidiaries following the Merger.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, successful development of TTI-101 and TTI-109, the development of new technological innovations by competitors, dependence on key personnel, the ability to attract and retain qualified employees, protection of proprietary technology, compliance with governmental regulations and the ability to secure additional capital to fund operations and commercial success of TTI-101 and TTI-109. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be maintained, that any therapeutic products developed will obtain required regulatory approval or that any approved or consumer products will be commercially viable. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate significant product sales.

Additionally, the Company is subject to risks and uncertainties as a 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. The extent to which business, political and macroeconomic factors, including increasing financial market volatility and uncertainty, will impact the Company’s business will depend on future developments that are highly uncertain and cannot be predicted at this time.

Liquidity and Going Concern

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business.

As of June 30, 2026, the Company had cash and cash equivalents of $15.8 million. Since inception, the Company has incurred net operating losses and negative cash flows from operations. During the three and six months ended June 30, 2026, the Company incurred net losses of $6.5 million and $13.3 million, respectively, and used $15.1 million of cash in operating activities during the six months ended June 30, 2026. As of June 30, 2026, the Company had an accumulated deficit of $123.7 million. The Company expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. Losses are expected to continue as the Company continues to invest in research and development activities. The Company evaluated whether there were conditions and events, considered in the aggregate, 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 the Company’s ability to continue as a going concern.

To date, the Company has no products approved for marketing and sale and it has not yet recorded any revenue from product sales. The Company’s ability to achieve profitability is dependent on its ability to successfully develop its compounds, conduct clinical trials, obtain regulatory approvals, and support commercialization activities for its product candidates. Any products developed will require approval of the U.S. Food and Drug Administration (FDA) or a foreign regulatory authority prior to commercial sale.

Significant additional funding is necessary to maintain current operations and to advance the Company’s research and development activities. The Company plans to seek additional funding through equity offerings or debt financings, credit or loan facilities, strategic alliances and licensing arrangements. The Company’s ability to access capital when and in the amount needed is not assured. As a result, the Company has concluded that management’s plans do not alleviate substantial doubt about the Company’s ability to continue as a going concern.

The accompanying condensed consolidated financial statements do not reflect any adjustments relating to the recoverability and reclassifications of assets and liabilities that might be necessary if the Company is unable to continue as a going concern.

Basis of Presentation

The accompanying condensed consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The accompanying condensed consolidated financial statements include the accounts of the Company and its consolidated subsidiaries as a result of the consummation of the Merger in April 2025. All intercompany balances and transactions have been eliminated.

The condensed consolidated financial statements reflect all adjustments (consisting of normal recurring adjustments) necessary to present fairly the financial position of the Company as of June 30, 2026 and December 31, 2025, and results of operations and cash flows for all periods presented. The interim results presented are not necessarily indicative of results that can be expected for the full year ending December 31, 2026.

Upon the closing of the Merger, the outstanding shares of common stock of Legacy Tvardi (including the shares of common stock issuable upon conversion of all shares of preferred stock of Legacy Tvardi prior to the Merger) were converted into shares of the Company’s common stock, based on an exchange ratio calculated in accordance with the Merger Agreement (the Exchange Ratio). The Exchange Ratio was retroactively applied to all outstanding common shares, redeemable convertible preferred stock, and stock options of Legacy Tvardi throughout the condensed consolidated financial statements and notes to condensed consolidated financial statements. Refer to Note 3 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December

31, 2025, as filed with the Securities and Exchange Commission (SEC) on March 31, 2026, for additional information regarding the Merger.

**2.**Summary of Significant Accounting Policies

Other than policies noted below, there have been no significant changes from the significant accounting policies and estimates disclosed in Note 2 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, and expenses as of and during the reporting period. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company assesses estimates on an ongoing basis; however, actual results could materially differ from those estimates. Significant estimates and assumptions reflected within these condensed consolidated financial statements include, but are not limited to, prepaid and accrued research and development expenses, including those related to contract research organizations (CROs), contract development manufacturing organizations (CDMOs), and other third-party vendors, and the valuation of the Company’s common stock prior to the Merger, stock-based awards, and the fair value of Convertible Notes (as defined in Note 11,Net (Loss) Income Per Share), which converted to common stock upon close of the Merger. Changes in estimates are recorded in the period in which they become known.

Concentration of Credit Risk and of Significant Suppliers

The Company’s cash and cash equivalents represent potential concentrations of credit risk. The Company deposits its cash and cash equivalents in financial institutions in amounts that may exceed federally insured limits, has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

The following table presents information about the Company’s significant suppliers:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the Three Months Ended · ​ · For the Six Months Ended · ​ · ​ · As of · ​ · As of · ​
​ · ​ · June 30, · ​ · June 30, · ​ · ​ · June 30, · ​ · December 31, · ​
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ · 2025 · ​ · ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​
​ · % of operating expenses · % of operating expenses · ​ · ​ · % of accounts payable · ​
Vendor A32%45%37%41%​76%84%

For the three and six months ended June 30, 2026 and 2025, no additional suppliers accounted for more than 10% of the Company’s operating expenses or accounts payable. The Company’s preclinical studies and clinical trials and testing could be adversely affected by a significant interruption in the supply chain from its significant suppliers.

Cash and Cash Equivalents

The Company considers all highly liquid investments, with an original maturity of three months or less, to be cash equivalents. Cash equivalents include amounts held in money market funds in the amount of $15.1 million and $20.0 million as of June 30, 2026 and December 31, 2025, respectively.

The Company recorded interest income on its cash equivalents of $0.2 million and $0.1 million for the three months ended June 30, 2026 and 2025, respectively, and $0.3 million for each of the six months ended June 30, 2026 and 2025 on its condensed consolidated statements of operations and comprehensive (loss) income.

Short-term Investments

The Company invests excess cash in short-term investments with high credit ratings. These securities consist primarily of U.S. Treasury Notes that are classified as “available-for-sale.” The Company classifies any investments as

short-term if the maturity date is less than or equal to one year from the balance sheet date or as long-term if the maturity date is in excess of one year from the balance sheet date.

The Company’s short-term investments are carried at fair value, with the unrealized gains and losses reported as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit). Realized gains and losses and declines in fair value due to credit-related factors are based on the specific identification method and would be included within the non-operating section of the condensed consolidated statements of operations and comprehensive (loss) income, as needed. The Company recorded interest income on short-term investments, inclusive of accretion of its discounts on its short-term investments, in an immaterial amount and $0.3 million during the three months ended June 30, 2026 and 2025, respectively, and $0.1 million and $0.4 million during the six months ended June 30, 2026 and 2025, respectively, which is classified as interest income in the condensed consolidated statements of operations and comprehensive (loss) income.

At each balance sheet date, the Company assesses available-for-sale debt securities in an unrealized loss position to determine whether the unrealized loss or any potential credit losses should be recognized within the non-operating section of the condensed consolidated statement of operations and comprehensive (loss) income. The Company evaluates whether it intends to sell, or it is more likely than not that it will be required to sell, the security before recovery of its amortized cost basis. The credit-related portion of unrealized losses, and any subsequent improvements, are recorded in the condensed consolidated statement of operations and comprehensive (loss) income accordingly, as needed. The portion that is not credit-related is treated in accordance with other unrealized losses as a component of accumulated other comprehensive income (loss) in stockholders’ equity (deficit). There have beenno impairment or credit losses recognized during the three and six months ended June 30, 2026 and 2025.

Comprehensive (Loss) Income

Comprehensive (loss) income is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from nonowner sources, including unrealized gains and losses on short-term investments held as available-for-sale. For the three and six months ended June 30, 2026, comprehensive loss includes net loss and a net unrealized loss on short-term investments. For the three months ended June 30, 2025, comprehensive income includes net income and a net unrealized loss on short-term investments and for the six months ended June 30, 2025, comprehensive loss includes net loss and a net unrealized loss on short-term investments.

Recently Issued Accounting Pronouncements Not Yet Adopted

In December 2025, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2025-11,Interim Reporting (Topic 270): Narrow Scope Improvements(or ASU 2025-11). The amendments in ASU 2025-11 are intended to improve the clarity and navigability of the interim reporting guidance in Topic 270 by clarifying its applicability, the types of interim reporting subject to the guidance, and the form and content of interim financial statements. The update also provides a comprehensive list of required interim disclosures and introduces a disclosure principle requiring entities to disclose events occurring since the end of the most recent annual reporting period that have a material impact on the entity, without fundamentally changing or expanding existing disclosure requirements. This guidance is effective for interim reporting periods within annual reporting periods beginning after December 15, 2027 for public business entities, with early adoption permitted. The Company is currently evaluating the provisions of this guidance and the potential impact on its condensed consolidated financial statements and disclosures.

In November 2024, the FASB issued ASU 2024-03,Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses(or ASU 2024-03). The amendments in ASU 2024-03 address investor requests for more detailed expense information and require additional disaggregated disclosures in the notes to financial statements for certain categories of expenses that are included in the statement of operations. This guidance is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the provisions of this guidance and the potential impact on its condensed consolidated financial statements and disclosures.

**3.**Fair Value Measurements

The following tables present information about the Company’s financial assets and liabilities measured at fair value on a recurring basis and indicate the level of the fair value hierarchy used to determine such fair values (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Fair Value Measurements as of
​ · ​ · June 30, 2026
​​ ​ ​Level 1​ ​ ​Level 2​ ​ ​Level 3​ ​ ​Total
Financial assets:​​​​​​​​
Cash equivalents:​​​​​​​​
Money market funds​$15,065​$—​$—​$15,065
Total financial assets​$15,065​$—​$—​$15,065
​​​​​​​​​​​​​
​ · ​ · Fair Value Measurements as of
​ · ​ · December 31, 2025
​ · ​ ​ ​ · Level 1 · ​ ​ ​ · Level 2 · ​ ​ ​ · Level 3 · ​ ​ ​ · Total
Financial assets: · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
Cash equivalents: · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
Money market funds​$20,011​$—​$—​$20,011
Short-term investments​​​​​​​​​​​​
U.S. Treasury Notes​​10,077​​—​​—​​10,077
Total financial assets​$30,088​$—​$—​$30,088

The Company didnot have any Level 3 assets or liabilities as of June 30, 2026 and December 31, 2025. There wereno transfers between Levels during the periods presented.

The unrealized losses on the Company’s short-term investments for the three and six months ended June 30, 2026 and 2025 were not material.

4.Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

​​​​​​​​
​ · ​ · As of June 30, · ​ · As of December 31, · ​
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​
Prepaid research and development expenses​$570​$303​
Prepaid insurance​​534​​194​
Other prepaid expenses​200​230​
Total prepaid expenses and other current assets​$1,304​$727​

**5.**Intangible Assets

Intangible assets consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​As of June 30,​As of December 31,​
​​ ​ ​2026​ ​ ​2025​ ​ ​
Licensed patent rights​$826​$826​
Less: accumulated amortization​(535)​(504)​
Total intangible assets, net​$291​$322​

As of June 30, 2026, the expected remaining amortization expense is as follows (in thousands):

​​​​
Year Ended December 31, · ​ ​ ​ · Amount
2026 (remaining six months)​$32
2027​63
2028​63
2029​63
2030​63
Thereafter​7
Total​$291

The Company recognized less than $0.1 million for amortization expense for each of the three and six months ended June 30, 2026 and 2025. Amortization expense is included in research and development expense in the condensed consolidated statements of operations and comprehensive (loss) income.

**6.**Accrued Expenses

Accrued expenses consisted of the following as of June 30, 2026 and December 31, 2025 (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​ ​ ​As of June 30,​As of December 31,​ ​ ​
​​ ​ ​2026​ ​ ​2025​ ​ ​
Accrued research and development expenses​$2,645​$5,744​
Accrued employee compensation and benefits​1,184​1,297​
Accrued professional fees​465​345​
Other accrued expenses​58​321​
Total accrued expenses​$4,352​$7,707​

**7.**Leases

The Company hasone operating lease pertaining to 5,969 square feet of corporate office space in Sugar Land, Texas pursuant to a lease agreement that commenced April 1, 2022. As of June 30, 2026, the remaining term of lease was 1.08 years. The lease requires monthly lease payments that are subject to annual increases throughout the lease term.

The components of lease costs, which are included within general and administrative expenses in the Company’s condensed consolidated statements of operations and comprehensive (loss) income were as follows (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ ​ ​ · For the Three Months Ended June 30, · ​ ​ ​ · For the Six Months EndedJune 30,
​​ ​ ​2026​ ​ ​2025​ ​ ​2026​ ​ ​2025
Lease costs:​​​​​​​​
Operating lease cost​$24​$24​$48​$48
Variable lease cost​21​18​43​40
Total lease costs​$45​$42​$91​$88

Supplemental disclosure of cash flow information related to the lease were as follows (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ ​ ​ · For the Three Months Ended June 30, · ​ ​ ​ · For the Six Months Ended June 30,
​​ ​ ​2026​ ​ ​2025​ ​ ​2026​ ​ ​2025
Operating cash flows from operating leases​$50​$50​$101​$100

The weighted-average discount rate and remaining lease term were as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ ​ ​ · For the Three Months Ended June 30, · ​ ​ ​ · For the Six Months Ended June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Weighted-average discount rate9.50%9.50%9.50%9.50%
Weighted-average remaining lease term1.082.08​1.082.08​

As of June 30, 2026, the maturities of the Company’s operating lease liabilities were as follows (in thousands):

​ · ​ · ​ · ​
Year Ended December 31,​ ​ ​Amount
2026 (remaining six months)​$65
2027​88
Total lease payments​153
Less: imputed interest​(8)
Present value of lease liabilities​145
Less: operating lease liabilities, current portion​$123
Operating lease liabilities, net of current portion​$22

**8.**Stockholders’ Equity (Deficit)

Preferred Stock

As of June 30, 2026, the Company had 5,000,000 shares of preferred stock authorized, $0.001 par value, pursuant to its amended and restated certificate of incorporation which was assumed in connection with the Merger Agreement in April 2025. However, no such shares were issued or outstanding as of June 30, 2026 or December 31, 2025.

Common Stock

As of June 30, 2026 and December 31, 2025, the Company’s amended and restated certificate of incorporation authorized the issuance of 150,000,000 shares of $0.001 par value common stock, of which 9,381,344 shares were issued and outstanding.

Each share of common stock entitles the holder toone vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Board of Directors, if any. As of June 30, 2026 and December 31, 2025, no dividends were declared.

Redeemable Convertible Preferred Stock

Prior to the Merger Agreement in April 2025, Legacy Tvardi had issued Series A preferred stock and Series B preferred stock (the Preferred Stock) and classified the Preferred Stock as temporary equity since the shares had redemption features that were not entirely within the control of Legacy Tvardi. Upon the closing of the Merger in April 2025, Legacy Tvardi’s Preferred Stock converted into 3,963,910 shares of the Company’s common stock. As a result, there wasno Preferred Stock remaining as of June 30, 2026 and December 31, 2025.

Shelf Registration and ATM Facility

On May 1, 2026, the Company filed a shelf registration statement on Form S-3 (the Registration Statement) which permits the offering, issuance and sale of common stock, preferred stock, debt securities and warrants having an aggregate offering price of up to $200.0 million in one or more offerings and in any combination of the foregoing. The Registration Statement containstwo prospectuses, a base prospectus and an at-the-market offering prospectus (the Original Sales Agreement Prospectus) that covered the offering, issuance and sale of up to $12.5 million of common stock pursuant to a Capital on Demand Sales Agreement (the Sales Agreement), dated as of May 1, 2026 by and between the Company and JonesTrading Institutional Services LLC acting as sales agent (the ATM Facility). The Registration Statement was declared effective by the SEC on May 12, 2026. As of June 30, 2026, no securities had been issued under

the Registration Statement, including the ATM Facility. See Note 15,Subsequent Events, for information regarding issuances of securities after June 30, 2026*.*

**9.**Stock-based Compensation

2018 Equity Incentive Plan

Legacy Tvardi’s 2018 Stock Incentive Plan (the 2018 Plan) provided employees, consultants and advisors and non-employee members of the Board of Directors and its affiliates with the opportunity to receive grants of stock options, stock awards and equity awards. Since inception, Legacy Tvardi only issued stock options. The Company assumed, effective as of the closing of the Merger, the 2018 Plan, as well as the outstanding awards granted thereunder and the award agreements evidencing the grants of such awards, including any awards granted to the Company’s named executive officers, in each case subject to applicable adjustments in the manner set forth in the Merger Agreement to such awards. No further awards will be granted under the 2018 Plan following the Merger.

2025 Equity Incentive Plan

The Company’s 2025 Equity Incentive Plan (the 2025 Plan) became effective at the closing of the Merger. As of the effective time of the Merger, there were 935,554 shares of the Company’s common stock available for grant under the 2025 Plan. In addition, the number of shares initially reserved and available for issuance under the 2025 Plan may be increased at the discretion of the Company’s Board of Directors (and without any further action by the Company’s stockholders) on January 1 of each year for a period offive years, commencing on January 1, 2026 and ending on January 1, 2030, in an amount not to exceed 5% of the total number of shares of the Fully Diluted Common Stock (as defined in the 2025 Plan) determined on December 31 of the preceding year, if the Company’s Board of Directors acts prior to January 1 of a given year to provide that the increase for such year will occur and to determine the applicable number of additional shares of the Company’s common stock. In the absence of action by the Company’s Board of Directors, no such increase will automatically occur. On January 1, 2026, the aggregate number of shares of common stock that may be issued pursuant to the 2025 Plan increased from 935,554 to 1,465,233, as approved by the Board of Directors.

Shares underlying any Awards that are forfeited, canceled, or reacquired by the Company prior to vesting, satisfied without the issuance of stock or otherwise terminated and shares that are withheld upon exercise of an option of settlement of an award to cover the exercise price or tax withholding shall be added back to the shares available for issuance under the 2025 Plan. As of June 30, 2026, the Company had 649,650 shares remaining available for grant under the 2025 Plan.

2025 Employee Stock Purchase Plan

The Company’s 2025 Employee Stock Purchase Plan (the 2025 ESPP) became effective at the closing of the Merger. As of the effective time of the Merger, there were 93,555 shares of the Company’s common stock reserved for issuance under the 2025 ESPP (the Initial Share Reserve). Additionally, the number of shares of common stock reserved for issuance under the 2025 ESPP will automatically increase on January 1 of each year for a period of up toten years, beginning on January 1, 2026 and continuing through and including January 1, 2035, by an amount equal to the lesser of (i)1% of the total number of shares of the Fully Diluted Common Stock (as defined in the 2025 ESPP) determined on December 31 of the preceding year, and (ii) a number of shares equal tothree times the Initial Share Reserve. Notwithstanding the foregoing, the Company’s Board of Directors may act prior to January 1st of a given year to provide that the increase for such year will be a lesser number of shares. No offering periods under the 2025 ESPP had been initiated as of June 30, 2026. On January 1, 2026, the aggregate number of shares of common stock that may be issued pursuant to the 2025 ESPP automatically increased from 93,555 to 199,490.

Fair Value Inputs

The fair value of stock option grants is estimated using the Black-Scholes option-pricing model. The Company historically had been a private company prior to the Merger and lacked company-specific historical and implied volatility information. Therefore, it estimated its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so after the Merger until such time as it has adequate

historical data regarding the volatility of its own publicly traded stock price. The expected option term is calculated based on the simplified method for awards with service-based conditions, which uses the midpoint between the vesting date and the contractual term, as the Company does not have sufficient historical data to develop an estimate based on participant behavior. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The following table presents the assumptions used in the Black-Scholes option-pricing model to determine the fair value of stock options granted. For options granted during the three and six months ended June 30, 2026 and 2025, the Company’s closing stock price on the grant date was used.

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the Three Months Ended · ​ · For the Six Months Ended
​ · ​ · June 30, · ​ · June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Per share fair value of common stock​$2.79​$17.04​$3.79​$17.04​
Expected volatility​67.6 - 68.0%​67.87 - 68.86%67.6 - 70.5%67.87 - 68.86%
Expected dividends​—%​—%—%—%
Expected term (in years)​5.50​​5.50 - 6.25​​5.50 - 6.25​5.50 - 6.25​
Risk-free rate​3.9 - 4.3%​4.0%3.8 - 4.3%4.0%

Stock Options

The Company granted 31,000 and 325,750 stock options during the three and six months ended June 30, 2026, respectively. The Company granted 397,940 stock options during the three months ended June 30, 2025. There wereno stock options granted during the three months ended March 31, 2025.

The weighted-average grant date fair value per share of options granted to non-employee members of the Company’s Board of Directors and a consultant during the three months ended June 30, 2026 was $1.73. The weighted-average grant date fair value per share of options granted to employees, non-employee members of the Company’s Board of Directors and a consultant during the six months ended June 30, 2026 was $2.51. The weighted-average grant date fair value per share of options granted to employees, non-employee members of the Company’s Board of Directors and consultants during the three months ended June 30, 2025 was $11.14. The forfeitures of stock options are recorded as incurred.

The following table summarizes option activity during the six months ended June 30, 2026:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · ​ · ​ · Weighted- · ​ · Weighted-Average · ​ · ​ · ​
​ · ​ · Number of · ​ · Average Exercise · ​ · Remaining Contractual · ​ · Intrinsic Value (In
​ · ​ ​ ​ · Options · ​ ​ ​ · Price · ​ ​ ​ · Term (In Years) · ​ ​ ​ · Thousands)
Outstanding as of January 1, 20261,212,246​$8.686.83​$1,086
Granted325,750​3.79​​​
Outstanding as of June 30, 20261,537,996​$7.647.03​$373
Options exercisable as of June 30, 2026873,832​$6.665.37​$373
Vested and expected to vest as of June 30, 20261,537,996​$7.647.03​$373

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the estimated fair value of the Company’s common stock for those stock options that had exercise prices lower than the estimated fair value of the Company’s common stock. There wereno exercises of stock options during the three and six months ended June 30, 2026. The aggregate intrinsic value of stock options exercised during each of the three and six months ended June 30, 2025 was $0.1 million.

The following table illustrates the classification of stock-based compensation in the condensed consolidated statements of operations and comprehensive (loss) income (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the Three Months Ended June 30, · ​ · For the Six Months Ended June 30,
​​ ​ ​2026​ ​ ​2025​ ​ ​2026​ ​ ​2025
Research and development​$92​$147​$185​$176
General and administrative​243​480​520​531
Total stock-based compensation​$335​$627​$705​$707

As of June 30, 2026, there was $3.9 million of total unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted-average period of 2.75 years.

**10.**Income Taxes

For the three and six months ended June 30, 2026 and 2025, there wasno current or deferred income tax expense or benefit due to the Company’s current year losses and full valuation allowance. As of June 30, 2026, the Company 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.

**11.**Net (Loss) Income Per Share

Basic and diluted net (loss) income per share attributable to common stockholders was calculated as follows (dollar amounts in thousands):

​​​​​​​​​​​​​
​ · ​ · For the Three Months Ended June 30, · ​ · For the Six Months Ended June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Numerator: · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
Net (loss) income for basic net (loss) income per share attributable to common stockholders​$(6,457)​$4,167​$(13,261)​$(5,412)
Reversal of fair market value remeasurement net gain on Convertible Notes (1)​​—​​(12,752)​​—​​(7,810)
Add back of interest expense from the Convertible Notes (1)​​—​​93​​—​​651
Net loss for diluted net loss per share attributable to common stockholders​$(6,457)​$(8,492)​$(13,261)​$(12,571)
​​​​​​​​​​​​​
Denominator:​​​​​​​​
Weighted-average common shares outstanding, basic​9,381,344​8,246,582​9,381,344​5,426,688
Effect of potentially dilutive securities:​​​​​​​​​​​​
Convertible Notes​​—​​208,641​​—​​734,279
Weighted-average common shares outstanding, diluted​​9,381,344​​8,455,223​​9,381,344​​6,160,967
​​​​​​​​​​​​​
Net (loss) income per share attributable to common stockholders:​​​​​​​​​​​​
Basic​$(0.69)​$0.51​$(1.41)​$(1.00)
Diluted​$(0.69)​$(1.00)​$(1.41)​$(2.04)

________________________

(1)In December 2024, Legacy Tvardi entered into a note purchase agreement to issue and sell convertible notes (the Convertible Notes). Under the fair value option, which the Company elected to account for its Convertible Notes, any change in fair value of the Convertible Notes was recorded to the Company’s condensed consolidated statements of operations and comprehensive (loss) income as a gain or loss from a fair value measurement. When calculating the diluted net loss per share for the prior year periods, the respective fair value remeasurement gain of $12.8 million and net gain of $7.8 million recognized in the condensed consolidated

statement of operations and comprehensive (loss) income during the three and six months ended June 30, 2025, respectively, were reversed and treated as an adjustment to the numerator. In addition, the $0.1 million and $0.7 million of interest expense from the Convertible Notes recognized in the condensed consolidated statements of operations and comprehensive (loss) income during the three and six months ended June 30, 2025, respectively, were added back as an adjustment to the numerator.

Upon the closing of the Merger in April 2025, the Convertible Notes converted into 1,265,757 shares of the Company’s common stock, $0.001 par value per share, in the aggregate. As a result, there wereno Convertible Notes outstanding as of June 30, 2026 and December 31, 2025.

For the three and six months ended June 30, 2026, the Company’s potentially dilutive securities include its stock options to purchase common stock. All of the Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share for the three and six months ended June 30, 2026, as the effect would be anti-dilutive. Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders for the three and six months ended June 30, 2026 is the same. For the three and six months ended June 30, 2025, the Company’s potentially dilutive securities included its stock options to purchase common stock, Preferred Stock, and Convertible Notes. The Company’s Convertible Notes had been included in the computation of diluted net loss per share for the three and six months ended June 30, 2025 as the effect was determined to be dilutive, while its stock options to purchase common stock and Preferred Stock were excluded from the diluted net loss per share calculation as the effect was determined to be anti-dilutive.

The following potentially dilutive securities have been excluded from the calculation of diluted net loss per share due to their anti-dilutive effect:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​​For the Three Months Ended June 30,​For the Six Months Ended June 30,
​ · ​ ​ ​ · 2026 · ​ ​ ​ · 2025 · ​ ​ ​ · 2026 · ​ ​ ​ · 2025
Stock options to purchase common stock1,537,9961,216,6421,537,9961,216,642

**12.**Commitments and Contingencies

Legal Matters

The Company is subject to contingent liabilities, such as legal proceedings and claims, that arise in the ordinary course of business activities. The Company accrues for loss contingencies when losses become probable and are reasonably estimable. If the reasonable estimate of the loss is a range and no amount within the range is a better estimate, the minimum amount of the range is recorded as a liability on the condensed consolidated balance sheets. The Company does not accrue for contingent losses that, in its judgment, are considered to be reasonably possible, but not probable; however, it discloses the range of reasonably possible losses. As of June 30, 2026 and December 31, 2025, the Company was not a party to any material legal proceedings or claims.

Contracts

The Company enters into contracts in the normal course of business with various third parties for preclinical research studies, clinical trials, testing, manufacturing, and other services. These contracts generally provide for termination upon notice and are cancellable without significant penalty or payment, and do not contain any minimum purchase commitments.

Guarantees and Indemnifications

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with all members of the Board of Directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any

material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its condensed consolidated financial statements as of June 30, 2026 and December 31, 2025.

Other Commitments

In addition to the Company’s obligation to make potential royalty payments under the BCM First Agreement and BCM Second Agreement (both as discussed and defined in Note 13,License Agreements), the Company is also obligated to pay royalties to each of its founders in an amount equal to 1% each on the worldwide net sales of TTI-101 and any derivative formulations, or any Royalty Bearing Products. These royalty obligations last, on a country-by-country basis, for the later of (i) the date on which the sale of any Royalty Bearing Products are no longer covered by a Covered Patent (as defined below) in such country, or (ii)15 years after the first commercial sale of royalty bearing product in such country. The timing of when these royalty payments will actually be made is uncertain as the payments are contingent upon future activities, including the successful development, regulatory approval and commercialization of any Royalty Bearing Products. A Covered Patent means, subject to certain customary exceptions, an issued patent that is owned by the Company or an affiliate, or for which all rights to develop and commercialize pharmaceutical products for the treatment of any human disorder, are exclusively licensed to the Company or an affiliate by the owner of such patent, with the Company’s right or its affiliate’s right to grant sublicenses.

**13.**License Agreements

In July 2012, Stem Med Limited Partnership (StemMed) entered into a license agreement (the BCM First Agreement) with Baylor College of Medicine (BCM) for the exclusive, worldwide, sublicensable license to certain patents and patent applications related to STAT3 inhibitors in oncology and certain non-oncology indications (the BCM Patent Rights), which are referred to together with certain cell lines, biological materials, compounds, know-how and technologies as the BCM Technology, in all fields of use. Under the license for the BCM First Agreement, the Company is permitted to make, have made, use, market, sell, offer to sell, lease and import products, processes or services that incorporate, utilize, or are made with the use of the BCM Patent Rights or BCM Technology, which is referred to together as the BCM1 Licensed Products, in all fields of use.

In June 2015, StemMed entered into a second license agreement with BCM (the BCM Second Agreement), which is referred to together with the BCM First Agreement as the BCM License Agreements, for the exclusive, worldwide, sublicensable license to certain patents and patent applications co-owned by BCM and the National Institutes of Health (NIH) related to methods and compositions for the use of STAT3 inhibitors in certain conditions like anaphylaxis (the Licensed Patent Rights). Under the license for the Second BCM Agreement, the Company is permitted to make, have made, use, market, sell, offer to sell, lease and import products, processes or services that incorporate, utilize or are made with the use of the Licensed Patent Rights (the BCM2 Licensed Products), in all fields of use. In April 2026, the Company terminated the BCM Second Agreement related to conditions like anaphylaxis, effective immediately. The Company determined that this termination was not material because the Company has not been and will not be pursuing development in conditions like anaphylaxis.

StemMed assigned the BCM First Agreement and the BCM Second Agreement to the Company in connection with the transfer of all or substantially all of the assets and businesses to which the BCM License Agreements relate to in January and February 2018.

In accordance with BCM License Agreements, and in consideration for the rights and licenses granted to the Company, the Company agreed to pay BCM the following:

a.Annual maintenance fees, ranging from $30,000 to $50,000 per year, per license.
b.Milestone payments, up to a low-seven digit figure in the aggregate.
c.Royalty fees, set at a low single-digit percentage of net sales of any BCM1 Licensed Products or BCM2 Licensed Products.

Milestones include new drug filings, clinical trial stages, and New Drug Application approval by the FDA.

As of June 30, 2026, the Company accrued $25,000 in annual maintenance fees. As of December 31, 2025, the full amount of $50,000 in annual maintenance fees had already been paid and thusno accrual was needed. No payments for maintenance or milestone fees were made during the three and six months ended June 30, 2026. 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) income.

**14.**Segment Reporting

The Company hasone reportable segment relating to the discovery and development of novel orally bioavailable, small molecule therapies across a broad range of diseases driven by STAT3 with high unmet need.

The Company’s Chief Operating Decision Maker (CODM), its Chief Executive Officer and Chief Financial Officer, manages the Company’s operations at a company-wide level for the purpose of allocating resources. The key measure of segment profit or loss that the CODM uses to allocate resources and assess financial performance is the Company’s net (loss) income, which is utilized to evaluate the progress of its research and development programs and other expense categories. The CODM makes decisions using this information on a company-wide basis.

The table below shows a reconciliation of the Company’s net (loss) income, including the significant expense categories regularly provided to and reviewed by the CODM, as computed under GAAP, to the Company’s net (loss) income in the condensed consolidated statements of operations and comprehensive (loss) income (in thousands):

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · For the Three Months Ended June 30, · ​ · For the Six Months EndedJune 30,
​​ ​ ​2026​ ​ ​2025​ ​ ​2026​ ​ ​2025
Direct research and development expenses by program:​​​​​​​​
TTI-101:​​​​​​​​
HCC​$1,118​$967​$1,818​$1,404
IPF​137​2,830​137​3,863
mBC​(5)​(268)​(5)​(268)
Pre-clinical, CMC, and other (unallocated) (1)​105​140​192​315
TTI-109​1,362​822​4,264​1,180
Unallocated research and development expense:​​​​​​​​
Personnel costs​926​917​1,930​1,775
Consultant fees and other costs (2)​359​398​577​648
General and administrative expense:​​​​​​​​
Personnel costs​933​1,038​1,865​1,647
Other general and administrative expenses (3)​1,694​2,025​2,902​2,659
Interest income​(172)​(377)​(419)​(652)
Other income, net​—​(12,659)​—​(7,159)
Net (loss) income​$(6,457)​$4,167​$(13,261)​$(5,412)
(1)Pre-clinical, chemistry, manufacturing and control (CMC), and other (unallocated) costs include preclinical testing, CMC, and other direct research and development expenses that are not allocated to a specific program.
(2)Consultant fees and other costs include expenses incurred for research and development consultants as well as payroll costs for employees within the research and development function.
(3)Other general and administrative expenses include professional fees, accounting services, rent, and other overhead and administrative expenses.

Assets provided to the CODM are consistent with those reported on the condensed consolidated balance sheets. The Company does not have intra-entity sales or transfers.

**15.**Subsequent Events

On July 17, 2026, the Company filed a new sales agreement prospectus supplement (New Sales Agreement Prospectus Supplement) included in the Registration Statement. The New Sales Agreement Prospectus Supplement reflects the offering, issuance and sale of up to approximately $9.7 million of common stock, in addition to any amounts previously sold by the Company.

The Company is subject to General Instruction I.B.6 of Form S-3 which limits the amounts that the Company may sell under the Registration Statement of which the New Sales Agreement Prospectus Supplement forms a part. Subsequent to June 30, 2026, the Company sold an aggregate of 3,110,769 shares of common stock for an aggregate offering price of approximately $11.0 million in gross proceeds under the Original Sales Agreement Prospectus (see Note 8,Stockholders’ Equity (Deficit)). No additional common stock will be sold under the Original Sales Agreement Prospectus following the date of the New Sales Agreement Prospectus Supplement.

From the date of the New Sales Agreement Prospectus Supplement through August 11, 2026, the Company sold an aggregate of 846,830 shares of common stock for an aggregate price of $2.3 million in gross proceeds under the New Sales Agreement Prospectus Supplement.

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