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Tvardi Therapeutics, Inc.

For the period ended Mar 31, 2025. Filed May 13, 2025.

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About this filing

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.

Mar 31, 2025 · Filed May 13, 2025

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

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Notes to Condensed Consolidated Financial Statements

  1. Business

On April 15, 2025 (the “Closing Date”), Cara Therapeutics, Inc., a Delaware corporation and our predecessor company (“Cara”), consummated the previously announced merger pursuant to the terms of the Agreement and Plan of Merger and Reorganization, dated as of December 17, 2024 (the “Merger Agreement”), by and among Cara, CT Convergence Merger Sub, Inc., a wholly owned subsidiary of Cara (“Merger Sub”), and Tvardi Therapeutics, Inc. (“Legacy Tvardi”). Pursuant to the Merger Agreement, on the Closing Date, (i) Cara effected a reverse stock split of Cara’s issued common stock at a ratio of 1:3 (the “2025 Reverse Stock Split”), (ii) Cara changed its name to “Tvardi Therapeutics, Inc.” (the “Name Change”), and (iii) Merger Sub merged with and into Legacy Tvardi, with Legacy Tvardi surviving the merger as a wholly owned subsidiary of Cara (the “Merger”) (together, the “Combined Company”).

In connection with the Merger, Cara and Legacy Tvardi entered into a registration rights agreement (the “Registration Rights Agreement”) with Legacy Tvardi’s greater than 5% stockholders, directors and/or entities affiliated with Legacy Tvardi, including Shaheen Wirk and his affiliated entities, David J. Tweardy and his affiliated entities and entities affiliated with Wallace Hall, pursuant to which the Combined Company agreed to use commercially reasonable efforts to prepare and file a registration statement with the Securities and Exchange Commission (the “SEC”) within 45 calendar days following the Closing Date for purposes of registering for resale shares of the Combined Company’s common stock issued to such parties upon the closing of the Merger. The Combined Company has also agreed, among other things, that it will indemnify such parties from certain liabilities and pay all fees and expenses (excluding any legal fees of the selling holder(s), and any underwriting discounts and selling commissions) incident to the Company’s obligations under the Registration Rights Agreement.

As of the open of trading on April 16, 2025, the common stock of the Combined Company began trading on the Nasdaq Capital Market (“Nasdaq”) under the symbol “TVRD.”

The Combined Company 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 Legacy Tvardi’s founder’s seminal work and deep understanding of the transcription factor, STAT3, the Combined Company has designed an innovative approach to directly inhibit STAT3, a highly validated, yet historically undruggable target. Leveraging this expertise, the Combined Company 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’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 expects to submit an Investigational New Drug application for TTI-109 in the first half of 2025.

The unaudited interim financial statements included in this Quarterly Report on Form 10-Q are representative of Cara’s operations prior to the closing of the Merger, the adoption of the Company’s business plan and the commencement of conducting Company’s business. Unless the context otherwise requires, references to the “Company” or “Tvardi” refer to Tvardi Therapeutics, Inc. after completion of the Merger. In addition, references to “Cara” refer to the Company prior to the completion of the Merger.

Nasdaq Continued Listing Rules

On February 1, 2024, Cara received a letter from The Nasdaq Stock Market (“Nasdaq”) notifying it that, for the previous 30 consecutive business day periods prior to the date of the letter, the closing bid price for Cara’s common

stock was below $1.00. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Cara was provided an initial period of 180 calendar days, or until July 30, 2024, to regain compliance with Nasdaq’s bid price requirement. On July 31, 2024, Cara received a notice (the “Extension Notice”) from the Listing Qualifications Department of Nasdaq informing it that Nasdaq granted the Company an additional 180 calendar days, or until January 27, 2025, to regain compliance with the minimum closing bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2), or the Rule. In connection with the Extension Notice, the listing of Cara’s common stock was transferred from the Nasdaq Global Market to the Nasdaq Capital Market, effective as of August 1, 2024. The Extension Notice had no other immediate effect on the listing of Cara’s common stock.

As part of Cara’s plans to regain compliance with the bid price requirement following the initial notification letter, a series of alternate amendments to effect (i) a reverse stock split and (ii) a reduction in the total number of authorized shares of the Cara’s common stock was approved by Cara’s stockholders at the Company’s 2024 Annual Meeting of Stockholders held on June 4, 2024.

On December 19, 2024, Cara’s Board of Directors approved a 1-for-12 reverse stock split of its issued and outstanding common stock (the “2024 Reverse Stock Split”), and corresponding reduction in the total number of authorized shares of common stock. On December 30, 2024, Cara filed a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the 2024 Reverse Stock Split, and Cara’s common stock began trading on the Nasdaq Capital Market on a post-split basis as of December 31, 2024.

On January 16, 2025, Cara received a letter from Nasdaq notifying it that Cara had regained compliance with the bid price requirement. The closing bid price of Cara’s common stock was at or above $1.00 per share for ten consecutive business days, and Nasdaq considers the matter closed.

As a result of the 2024 Reverse Stock Split, every 12 shares of Cara’s pre-reverse split common stock were combined and reclassified asone share of common stock. The proportionate voting rights and other rights of common stockholders were not affected by the 2024 Reverse Stock Split, other than as the result of payment for fractional shares. No fractional shares were issued in connection with the 2024 Reverse Stock Split. Stockholders who would have held a fractional share of common stock received a cash payment in lieu thereof. The par value and other terms of Cara’s common stock were not affected by the 2024 Reverse Stock Split.

All share and per share information have been retroactively adjusted to give effect to the 2024 Reverse Stock Split for all periods presented, unless otherwise indicated. Proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options and restricted stock units outstanding for all periods presented, which resulted in a proportional decrease in the number of shares of Cara’s common stock reserved for issuance upon exercise or vesting of such stock options and restricted stock units, and in the case of stock options, a proportional increase in the exercise price of all such stock options (see Note 18,Subsequent Events).

Nasdaq Listing Rule 5550(b)(1) requires companies listed on the Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500 (the “Stockholders’ Equity Requirement”), or the alternative requirements of having a market value of listed securities of $35,000 or net income from continuing operations of $500 in the most recently completed fiscal year or two of the last three most recently completed fiscal years (the “Alternative Standards”). As of March 31, 2025, Cara had negative stockholders’ equity of $8,073 and therefore Cara was not in compliance with the Stockholders’ Equity Requirement and, as of March 31, 2025, did not meet the Alternative Standards.

As requested by Nasdaq, Cara subsequently submitted a plan to regain compliance to Nasdaq (the “Compliance Plan”). On January 14, 2025, based on the Compliance Plan, which contemplated the closing of the proposed Merger between Cara and Legacy Tvardi, Nasdaq granted Cara an extension until May 19, 2025 to regain compliance with the Stockholders’ Equity Requirement.

The Merger constituted a “change of control” for purposes of Nasdaq’s listing rules and required that the combined company comply with all applicable criteria for initial listing on the Nasdaq Capital Market, including a higher bid price requirement and higher Stockholders’ Equity Requirement. The parties satisfied each of the applicable listing criteria upon completion of the proposed Merger such that the combined company remains listed on the Nasdaq Capital Market (see Note 18,Subsequent Events).

  1. Basis of Presentation

The condensed consolidated financial statements included herein include the results of the financial operations of Cara Therapeutics, Inc. and its wholly-owned subsidiary, Cara Royalty Sub, LLC (“Cara Royalty Sub”), a Delaware limited liability company which was formed in November 2023 for the purpose of the transactions contemplated by the Original HCR Agreement described in Note 9,Royalty Purchase and Sale Agreement. All intercompany balances and transactions have been eliminated.

The unaudited interim condensed consolidated financial statements included herein have been prepared pursuant to the rules and regulations of the SEC. Accordingly, they do not include all information and disclosures necessary for a presentation of the Cara’s financial position, results of operations and cash flows in conformity with generally accepted accounting principles in the United States of America (“GAAP”). In the opinion of management, these unaudited interim condensed consolidated financial statements reflect all adjustments, consisting primarily of normal recurring accruals, necessary for a fair presentation of results for the periods presented. The results of operations for interim periods are not necessarily indicative of the results for the full year. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by SEC rules and regulations; however, the Company believes that the disclosures are adequate to make the information presented not misleading. The condensed consolidated balance sheet data as of December 31, 2024 were derived from audited financial statements, but do not include all disclosures required by GAAP. These unaudited interim condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

On December 30, 2024, Cara effected the 2024 Reverse Stock Split. Additionally, concurrently with the closing of the Merger on April 15, 2025, as described in more detail in Note 18,Subsequent Events, Cara effected the 2025 Reverse Stock Split. Unless otherwise indicated, all share and per share amounts contained in these condensed consolidated financial statements and accompanying notes, and elsewhere in this Quarterly Report on Form 10-Q, give retroactive effect to the 2024 Reverse Stock Split and 2025 Reverse Stock Split.

Use of Estimates

The preparation of condensed consolidated financial statements in conformity with GAAP requires Cara to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, as of the date of the condensed consolidated financial statements as well as the reported amounts of revenues and expenses during the reporting period. The more significant estimates include the amount and periods over which certain revenues will be recognized, including future ex-U.S. royalties and milestones projected in relation to the HCR Agreement, related party accounts receivable reserve, as applicable, inventory valuation and related reserves,

research and development (“R&D”), clinical costs, as applicable, and accrued research projects included in prepaid expenses and accounts payable and accrued expenses, as applicable, the amount of non-cash compensation costs related to share-based payments to employees and non-employees, restructuring costs, as applicable, and the likelihood of realization of deferred tax assets.

The impact from global economic conditions and potential and continuing disruptions to and volatility in the credit and equity markets in the United States and worldwide are highly uncertain and cannot be predicted, including impacts from global health crises, geopolitical tensions, such as the ongoing conflicts between Russia and Ukraine, conflict in the Middle East, and increasing tensions between China and Taiwan, and government actions implemented as a result of the foregoing, fluctuations in inflation, rising interest rates, tariffs, uncertainty and liquidity concerns in the broader financial services industry, and a potential recession in the United States. Estimates and assumptions about future events and their effects cannot be determined with certainty and therefore require the exercise of judgment. As of the date of issuance of these condensed consolidated financial statements, Cara is not aware of any specific event or circumstance that would require Cara to update its estimates, assumptions and judgments or revise the reported amounts of assets and liabilities or the disclosure of contingent assets and liabilities. These estimates, however, may change as new events occur and additional information is obtained, and are recognized in the condensed consolidated financial statements as soon as they become known.

Actual results could differ materially from the Company’s estimates and assumptions.

Significant Accounting Policies

There have been no material changes to the significant accounting policies previously disclosed in Note 2 to the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

Segment Reporting

On June 14, 2024, Cara’s Board of Directors approved a streamlined operating plan exploring strategic alternatives focused on maximizing shareholder value after Cara announced its decision to discontinue the clinical program in notalgia paresthetica (“NP”) on June 12, 2024. Prior to Cara’s winddown of its historical operations, Cara was a biopharmaceutical corporation focused on improving the lives of patients suffering from chronic pruritus. Cara viewed its operations and managed its business as a single operating segment that constituted all of the consolidated entity, which historically included all activities related to the discovery, development, and commercialization of its product, difelikefalin, to treat chronic pruritus. The accounting policies of the segment are the same as those described throughout Note 2 to the Consolidated Financial Statements in Cara’s Annual Report on Form 10-K for the year ended December 31, 2024. As a result, there are no differences from Cara’s last Annual Report in the segmentation or measurement basis for segment profit or loss.

Cara’s Chief Operating Decision Maker (“CODM”) was its Chief Executive Officer. The key measure of segment profit or loss that the CODM used to allocate resources and assess performance was Cara’s consolidated net loss, as reported in its Condensed Consolidated Statements of Comprehensive Loss. Consolidated net loss, including significant expense line items, was also used to monitor budget versus actual results. All revenue and expense categories in the Condensed Consolidated Statements of Comprehensive Loss were significant and regularly reviewed by the CODM. Other information not disclosed separately in the Statements of Comprehensive Loss for the segment include 1) interest revenue and other expenses which are historically netted together within interest income, net on the Condensed Consolidated Statements of Comprehensive Loss, of which almost all relate to interest revenue and only an immaterial

amount historically relates to other expenses; and 2) depreciation and amortization expense of $0 and $42 which are included within R&D and G&A expense line items in the Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2025 and 2024, respectively.

The measure used by the CODM for segment assets is reported in the Condensed Consolidated Balance Sheets as total consolidated assets, with particular emphasis on Cara’s available liquidity, including its cash, cash equivalents and restricted cash, as applicable, accounts receivable – related party, net, and available-for-sale marketable securities, as applicable, reduced by Cara’s liabilities also included on the Condensed Consolidated Balance Sheets.

Cara did not have intra-entity sales or transfers.

Accounting Pronouncements Recently Adopted

In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09,Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which applies to all entities subject to income taxes. ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is intended to provide more detailed income tax disclosures. For public business entities, the new requirements became effective for annual periods beginning after December 15, 2024. ASU 2023-09 will be applied on a prospective basis with the option to apply the standard retrospectively. Cara adopted ASU 2023-09 on January 1, 2025, and it does not expect the adoption to have a material effect on its results of operations, financial position, and cash flows.

Accounting Pronouncements Not Yet Adopted

In November 2024, the FASB issued ASU 2024-03,Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40) (“ASU 2024-03”), which applies to all public business entities. ASU 2024-03 requires disclosures about specific types of expenses included in the expense captions presented on the face of the income statement as well as disclosures about selling expenses. The new standard requires that a public business entity disclose in the footnotes the following information at each interim and annual reporting period: 1) purchases of inventory; 2) employee compensation; 3) depreciation; 4) intangible asset amortization; and 5) depreciation, depletion, and amortization recognized as part of oil and gas-producing activities. Public business entities are also required to include certain expense, gain, or loss amounts that are already required to be disclosed under GAAP, a qualitative description of the amounts remaining in relevant expense captions that are not separately disaggregated quantitatively, and the total amount of selling expenses and, in annual reporting periods, the entity’s definition of selling expenses. The new standard does not change the requirements for the presentation of expenses on the face of the income statement. For all public business entities, the new requirements will be effective for annual periods beginning after December 15, 2026, and interim periods within annual periods beginning after December 15, 2027. The requirements will be applied prospectively with the option for retrospective application. Early adoption is permitted. Cara expects to adopt ASU 2024-03 on January 1, 2027, and it does not expect the adoption to have a material effect on its results of operations, financial position, and cash flows.

Liquidity and Going Concern

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

Since inception, the Combined Company has incurred net operating losses and negative cash flows from operations. As mentioned above and further discussed in Note 18,Subsequent Events, following the closing of the Merger on the Closing Date, Legacy Tvardi received approximately $23,800 in cash and cash equivalents from Cara. The Combined 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 Combined Company continues to invest in research and development activities. The assessment of the Combined Company’s ability to meet its future obligations is inherently judgmental, subjective and susceptible to change. Given the inherent uncertainties in the forecast, the Combined Company 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 the Combined Company’s ability to continue as a going concern.

To date, the Combined Company has no products approved for marketing and sale and it has not yet recorded any revenue from product sales. The Combined Company’s ability to achieve profitability is dependent on its ability to successfully develop its lead compound, 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.

Since inception, the Combined Company has relied primarily on sales of redeemable convertible preferred stock and issuance of convertible debt to fund its operations. The Combined Company’s product candidates are still in the early stages of development, and substantial additional financing will be needed by the Combined Company to fund its operations and ongoing research and development efforts prior to the commercialization of its product candidates.

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

  1. Accumulated Other Comprehensive Loss

The following table summarizes the changes in accumulated other comprehensive loss, net of tax, from unrealized gains on available-for-sale marketable securities, Cara’s only component of accumulated other comprehensive loss, for the three months ended March 31, 2024. There wereno unrealized gains or losses on available-for-sale marketable securities for the three months ended March 31, 2025, as all such investments matured in November 2024.

​​​​
​Total Accumulated
​ · ​ · Other Comprehensive
​ · ​ · Loss
Balance, December 31, 2024​$—
Other comprehensive income before reclassifications​—
Amount reclassified from accumulated other comprehensive loss​—
Net current period other comprehensive income​—
Balance, March 31, 2025​$—
​​​​
Balance, December 31, 2023​$(260)
Other comprehensive income before reclassifications​69
Amount reclassified from accumulated other comprehensive loss​—
Net current period other comprehensive income​69
Balance, March 31, 2024​$(191)

Amounts reclassified out of accumulated other comprehensive loss into net loss are determined by specific identification. There wereno reclassifications out of accumulated other comprehensive loss and into net loss for each of the three months ended March 31, 2025 and 2024.

  1. Fair Value Measurements

As of March 31, 2025 and December 31, 2024, Cara’s financial instruments consisted of cash and cash equivalents, accounts receivable, net – related party, other receivables, prepaid expenses, accounts payable and accrued liabilities, and liability related to the sales of future royalties and milestones. The fair values of cash and cash equivalents, accounts receivable, net – related party, other receivables, prepaid expenses, accounts payable and accrued liabilities approximate their carrying values due to the short-term nature of these financial instruments. The fair value of the liability related to the sales of future royalties and milestones also approximates the carrying value.

The following tables summarize Cara’s financial assets measured at fair value on a recurring basis as of March 31, 2025 and December 31, 2024.

Fair value measurement as of** March 31, 2025**:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · ​ · ​ · ​ · Quoted prices in · ​ · Significant other · ​ · Significant
Financial assets · ​ · ​ · ​ · ​ · active markets for · ​ · observable · ​ · unobservable
​ · ​ · ​ · ​ · ​ · identical assets · ​ · inputs · ​ · inputs
Type of Instrument · Total · (Level 1) · (Level 2) · (Level 3)
Cash and cash equivalents: · ​ · ​ · ​ · ​
Money market funds and checking accounts​$34,217​$34,217​$—​$—
Total financial assets​$34,217​$34,217​$—​$—

Fair value measurement as of December 31, 2024:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · ​ · ​ · ​ · Quoted prices in · ​ · Significant other · ​ · Significant
Financial assets · ​ · ​ · ​ · ​ · active markets for · ​ · observable · ​ · unobservable
​ · ​ · ​ · ​ · ​ · identical assets · ​ · inputs · ​ · inputs
Type of Instrument · Total · (Level 1) · (Level 2) · (Level 3)
Cash and cash equivalents: · ​ · ​ · ​ · ​
Money market funds and checking accounts​$37,903​$37,903​$—​$—
Total financial assets​$37,903​$37,903​$—​$—

There wereno purchases, sales or maturities of Level 3 financial assets andno unrealized gains or losses related to Level 3 available-for-sale marketable securities during each of the three months ended March 31, 2025 and 2024. There wereno transfers of financial assets into or out of Level 3 classification during the three months ended March 31, 2025 and 2024.

  1. Restricted Cash

Cara historically had restricted cash balances that related to former lease agreements that terminated in prior periods. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the Condensed Consolidated Balance Sheets that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows. For the three months ended March 31, 2024, $408 of restricted cash became unrestricted in January 2024 and $1,500 of restricted cash became unrestricted in October 2024 in relation to the termination of these former lease agreements. There wasno restricted cash as of March 31, 2025 or December 31, 2024.

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · March 31, 2025 · December 31, 2024
Cash and cash equivalents​$34,217​$37,903
Restricted cash, current assets​—​—
Restricted cash, long-term assets​—​—
Total cash, cash equivalents, and restricted cash shown in the Condensed Consolidated Statements of Cash Flows​$34,217​$37,903
  1. Inventory, net

Inventory, net consists of the following:

​​​​​​​
​ · March 31, 2025 · December 31, 2024
Raw materials​$2,124​$2,124
Work-in-process​291​291
​​​2,415​​2,415
Less Inventory Reserve for Obsolescence​(1,515)​(1,515)
Total​$900​$900

As of March 31, 2025 and December 31, 2024, inventory balances include inventory costs subsequent to regulatory approval of KORSUVA injection on August 23, 2021. There wereno write-downs of commercial supply inventory during each of the three months ended March 31, 2025 and 2024.

On December 17, 2024, in connection with the Merger Agreement, Cara and Cara Royalty Sub (the “Cara Sellers”) entered into an Asset Purchase Agreement (the “APA”) with Vifor Fresenius Medical Care Renal Pharma Ltd., pursuant to which, at the consummation of the Merger Agreement, Cara Sellers sold to CSL Vifor certain assets and rights for the development, manufacture and commercialization of difelikafalin as well as certain associated liabilities (the “Asset Disposition”), for a purchase price of $900 (subject to certain adjustments with respect to inventory). Additionally, pursuant to the APA, at the consummation of the Asset Disposition, Cara paid CSL Vifor $3,000 to compensate CSL Vifor for the estimated incremental future expenses incurred by CSL Vifor as a result of the transfer of the assets acquired and the liabilities assumed by it in connection with the Asset Disposition (see Note 18,Subsequent Events).

  1. Prepaid expenses

As of March 31, 2025, prepaid expenses were $1,592, consisting of $5 of prepaid R&D clinical costs, $1,475 of prepaid insurance and $112 of other prepaid costs. As of December 31, 2024, prepaid expenses were $529, consisting of $13 of prepaid R&D clinical costs, $149 of prepaid insurance, and $367 of other prepaid costs.

  1. Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses consist of the following:

​ · ​ · ​ · ​ · ​ · ​ · ​
​ · March 31, 2025 · December 31, 2024
Accounts payable​$4​$1,434
Accrued research projects​70​64
Accrued compensation and benefits​606​565
Accrued professional fees and other​519​1,909
Total​$1,199​$3,972

9. Royalty Purchase and Sale Agreement

During the fourth quarter of 2023, Cara, through its wholly-owned subsidiary Cara Royalty Sub, entered into the Purchase and Sale Agreement (the “Original HCR Agreement”) by and among Cara Royalty Sub, HCRX Investments HoldCo, L.P. (“HCRX”) and HealthCare Royalty Partners IV, L.P. (“HCR IV” and together with HCRX, “HCR”), pursuant to which Cara Royalty Sub sold, or agreed to sell, to HCR certain of its rights to receive royalty payments (the “Royalties”), due and payable to Cara Royalty Sub (as assignee of Cara) under the Maruishi Agreement and Vifor Agreement No. 2. (as defined below), collectively the Covered License Agreements, in exchange for up to $40,000. Cara has retained all of its rights, title and interest in, to and under the Covered License Agreements that relate to any non-intravenous formulation of difelikefalin.

Under the terms of the Original HCR Agreement, Cara Royalty Sub received an upfront payment of $16,915 in November 2023, representing the $17,500 to which the Company was initially entitled, net of advisory fees and certain of HCR’s transaction-related expenses which Cara agreed to reimburse. In December 2023, Cara Royalty Sub received an additional payment of $19,770, representing the $20,000 milestone it achieved for Kapruvia (difelikefalin) pricing in Germany being approved above a certain threshold amount per dose, net of advisory fees. There were additional issuance costs of $211 related to the HCR Agreement resulting in aggregate net proceeds of $36,474. An additional $2,500 milestone payment was received in March 2025 upon achievement of a 2024 sales milestone of KORSUVA in Japan.

The Original HCR Agreement will automatically expire, and the payment of Royalties to HCR will cease, when HCR has received payments of Royalties equal totwo times the aggregate amount of payments made by HCR under the Original HCR Agreement if achieved on or prior to December 31, 2029, or 2.8 times the aggregate amount of payments made by HCR under the Original HCR Agreement, if not achieved on or prior to December 31, 2029. After the Original HCR Agreement expires, all rights to receive the Royalties return to Cara Royalty Sub.

Issuance costs pursuant to the Original HCR Agreement consisting primarily of advisory and legal fees totaled $1,025 including the amount of HCR’s transaction-related expenses that Cara reimbursed. The effective interest rate includes cash flow projections for future royalty and milestone payments, which are sensitive to certain assumptions, including market size, market penetration and sales price, that are forward looking and could be affected by future market conditions. During the three months ended March 31, 2025 and 2024, $1,494 and $685, respectively, were repaid to HCR under the Original HCR Agreement.

On December 17, 2024, in connection with the Merger Agreement, Cara Sellers entered into the APA with Vifor Fresenius Medical Care Renal Pharma Ltd., pursuant to which, at the consummation of the Merger Agreement, Cara Sellers and CSL Vifor entered into the Asset Disposition for a purchase price of $900 (subject to certain adjustments with respect to inventory). Additionally, pursuant to the APA, at the consummation of the Asset Disposition, Cara paid CSL Vifor $3,000 to compensate CSL Vifor for the estimated incremental future expenses incurred by CSL Vifor as a result of the transfer of the assets acquired and the liabilities assumed by it in connection with the Asset Disposition. Pursuant to the APA, in connection with the consummation of the Asset Disposition, CSL Vifor and HCR entered into a letter agreement with Cara to amend and replace the Original HCR Agreement (see Note 18,Subsequent Events).

The following table summarizes the activity of the Original HCR Agreement during the three months ended March 31, 2025 (in thousands):

​​​​​
Royalty purchase and sale agreement balance at December 31, 2024$44,448​
Payments​(1,494)​
Non-cash interest expense​​2,867​
Balance at March 31, 2025​$45,821​
​​​​​
Effective interest rate​27.85%
​​​​​
  1. Stockholders’ Equity

On December 19, 2024, Cara’s Board of Directors approved the 2024 Reverse Stock Split, and corresponding reduction in the total number of authorized shares from 200,000,000 to 16,666,667 (the “Authorized Shares Reduction”). On December 30, 2024, Cara filed a Certificate of Amendment to its Certificate of Incorporation with the Secretary of State of the State of Delaware to effect the 2024 Reverse Stock Split and Authorized Shares Reduction, and Cara’s common stock began trading on the Nasdaq Capital Market on a post-split basis as of December 31, 2024. On April 15, 2025, Cara effected the 2025 Reverse Stock Split and increased its authorized shares of common stock (see Note 18,Subsequent Events). As of March 31, 2025, there were 1,524,535 shares ofcommon stock andno shares of preferred stock issued andoutstanding.

All share and per share information for the periods presented have been retroactively adjusted to give effect to the 2024 Reverse Stock Split and the 2025 Reverse Stock Split, unless otherwise indicated. Proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock

options and restricted stock units, which resulted in a proportional decrease in the number of shares of Cara’s common stock reserved for issuance upon exercise or vesting of such stock options and restricted stock units, and in the case of stock options, a proportional increase in the exercise price of all such stock options.

During the three months ended March 31, 2025, an aggregate of 792 time-based restricted stock units of certain employees vested and were settled in shares of Cara’s common stock. During the three months ended March 31, 2024, an aggregate of 1,274 time-based restricted stock units of certain employees vested and were settled in shares of Cara’s common stock (See Note 14,Stock-Based Compensation).

During the three months ended March 31, 2025, no performance-based restricted stock units vested or were settled in shares of Cara’s common stock. During the three months ended March 31, 2024, an aggregate of 3,903 performance-based restricted stock units of certain employees vested and were settled in shares of Cara’s common stock (See Note 14,Stock-Based Compensation).

  1. Collaboration and Licensing Agreements

Vifor (International) Ltd. (Vifor International)

In October 2020, Cara entered into a license agreement with Vifor International (“Vifor Agreement No. 1”), under which Cara granted Vifor International an exclusive license solely in the United States to use, distribute, offer for sale, promote, sell and otherwise commercialize difelikefalin injection for all therapeutic uses relating to the inhibition, prevention or treatment of itch associated with pruritus in hemodialysis and peritoneal dialysis patients in the United States. Under Vifor Agreement No. 1, Cara retains all rights with respect to the clinical development of, and activities to gain regulatory approvals of, difelikefalin injection in the United States. In conjunction with the consummation of the Asset Disposition, Vifor Agreement No. 1 was terminated (see Note 18,Subsequent Events).

After the assignment of rights of Vifor Agreement No. 1 from Vifor International to Vifor Fresenius Medical Care Renal Pharma Ltd. in May 2022, Vifor Agreement No. 1 provided full commercialization rights in dialysis clinics to CSL Vifor in the United States under a profit-sharing arrangement. Pursuant to the profit-sharing arrangement, Cara was generally entitled to 60% of the net profits (as defined in Vifor Agreement No. 1) from sales of difelikefalin injection in the United States and CSL Vifor was entitled to 40% of such net profits (excluding sales to Fresenius Medical Center dialysis clinics, compensation for which was governed by Vifor Agreement No. 2, as defined below), subject to potential temporary adjustment in future years based on certain conditions. Under Vifor Agreement No. 1, in consideration of CSL Vifor’s conduct of the marketing, promotion, selling and distribution of difelikefalin injection in the United States, Cara paid a marketing and distribution fee to CSL Vifor based on the level of annual net sales. This fee as well as CSL Vifor’s cost of goods sold (“COGS”) were deducted from net sales in calculating the net profits that are subject to the profit-sharing arrangement under Vifor Agreement No. 1.

In addition, pursuant to Vifor Agreement No. 1, Cara was eligible to receive payments of up to $240,000 upon the achievement of certain sales-based milestones.

Cara retained the rights to make and have made difelikefalin injection (the “Licensed Product”) on a non-exclusive basis, in the United States for commercial sale of the Licensed Product for use in all therapeutic areas to prevent, inhibit or treat itch associated with pruritus in hemodialysis and peritoneal-dialysis patients (the “Field”) anywhere in the world and for supply of Licensed Product to CSL Vifor under the terms of a supply agreement (the “Vifor International Supply Agreement”) which was executed in September 2021. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor International Supply Agreement would co-terminate with Vifor Agreement No.

  1. Cara also retained the rights to import, distribute, promote, sell and otherwise commercialize the Licensed Product on an exclusive basis outside of the Field either in or outside of the United States.

The Vifor International Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor International Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of commercial supply to CSL Vifor is not a performance obligation under Vifor Agreement No. 1 but rather the Vifor International Supply Agreement is a separate agreement from Vifor Agreement No. 1. The only performance obligation under the Vifor International Supply Agreement is the delivery of the Licensed Product to CSL Vifor for commercialization. In connection with the consummation of the Asset Disposition, the Vifor International Supply Agreement was terminated (see Note 18,Subsequent Events).

Vifor Fresenius Medical Care Renal Pharma Ltd.

In May 2018, Cara entered into a license agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (“Vifor Agreement No. 2”) under which Cara granted Vifor Fresenius Medical Care Renal Pharma Ltd. an exclusive, royalty-bearing license, or the Vifor License, to seek regulatory approval to commercialize, import, export, use, distribute, offer for sale, promote, sell and otherwise commercialize the Licensed Product in the Field worldwide (excluding the United States, Japan and South Korea) (the “Territory”). In connection with the consummation of the Asset Disposition, Vifor Agreement No. 2 was terminated (see Note 18,Subsequent Events).

Cara was eligible to receive from Vifor Fresenius Medical Care Renal Pharma Ltd. additional commercial milestone payments in the aggregate of up to $440,000, all of which are sales related. Cara was also eligible to receive tiered double-digit royalty payments based on annual net sales, as defined in Vifor Agreement No. 2, of difelikefalin injection in the licensed territories. Cara retained full commercialization rights for difelikefalin injection for the treatment of chronic kidney disease associated pruritus in the United States except in the dialysis clinics of FMCNA, where Vifor Fresenius Medical Care Renal Pharma Ltd. will promote difelikefalin injection under a profit-sharing arrangement (as defined in Vifor Agreement No. 2), based on net FMCNA clinic sales (as defined in Vifor Agreement No. 2) and Cara and Vifor Fresenius Medical Care Renal Pharma Ltd. were each entitled to 50% of such net profits, subject to potential adjustments in a calendar year based on certain conditions.

Cara retained the rights to make and have made the Licensed Product in the Territory for commercial sale by Vifor Fresenius Medical Care Renal Pharma Ltd. in the Field in or outside the Territory and for supply of Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. under the terms of a supply agreement (the “Vifor Supply Agreement”) which was executed in May 2020. The supply price was Cara’s COGS, as calculated under GAAP, plus an agreed upon margin. The Vifor Supply Agreement would co-terminate with Vifor Agreement No. 2.

The Vifor Supply Agreement is accounted for as a customer option that is not a material right because the selling price of the Licensed Product under the Vifor Supply Agreement is Cara’s COGS plus an agreed upon margin, which is commensurate with the “COGS plus” model that Cara would charge other parties under similar agreements (the standalone selling price) and not at a discount. Therefore, the sale of compound to Vifor Fresenius Medical Care Renal Pharma Ltd. is not a performance obligation under Vifor Agreement No. 2 but rather the Vifor Supply Agreement is a separate agreement from Vifor Agreement No. 2. The only performance obligation under the Vifor Supply Agreement is the delivery of the Licensed Product to Vifor Fresenius Medical Care Renal Pharma Ltd. for commercialization. In connection with the consummation of the Asset Disposition, the Vifor Supply Agreement was terminated (see Note 18,Subsequent Events).

Maruishi Pharmaceutical Co., Ltd. (Maruishi)

In April 2013, Cara entered into a license agreement with Maruishi (the “Maruishi Agreement”) under which Cara granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitled Cara to receive sub-license fees, net of prior payments made by Maruishi to Cara. Under the Maruishi Agreement, Cara and Maruishi were required to use commercially reasonable efforts, at their own expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and Japan, respectively. In addition, Cara provided Maruishi specific clinical development services for difelikefalin used in Maruishi’s field of use.

Under the terms of the Maruishi Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, low double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees.

In September 2022, Maruishi submitted a New Drug Application in Japan for approval of difelikefalin injection for the treatment of pruritus in hemodialysis patients. In September 2023, Maruishi received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. In November 2023, Cara entered into an API supply agreement with Maruishi for difelikefalin. In connection with the consummation of the Asset Disposition, Cara assigned the Maruishi Agreement and the API supply agreement with Maruishi to CSL Vifor (see Note 18,Subsequent Events).

Chong Kun Dang Pharmaceutical Corporation (CKDP)

In April 2012, Cara entered into a license agreement with CKDP (the “CKDP Agreement”) in South Korea, under which Cara granted CKDP an exclusive license to develop, manufacture and commercialize drug products containing difelikefalin in South Korea. Cara and CKDP are each required to use commercially reasonable efforts, at their respective expense, to develop, obtain regulatory approval for and commercialize difelikefalin in the United States and South Korea, respectively. In connection with the consummation of the Asset Disposition, Cara assigned the CKDP Agreement to CSL Vifor (see Note 18,Subsequent Events).

Under the terms of the CKDP Agreement, Cara was eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered royalties, with percentages ranging from the high single digits to the high teens, based on net sales of products containing difelikefalin in South Korea, if any, and share in any sub-license fees.

  1. Revenue Recognition

Cara has recognized revenue under its license and collaboration agreements from (1) its share of the profit generated by KORSUVA injection sales in the United States during each of the three months ended March 31, 2025 and 2024; (2) commercial supply revenue from Cara’s sales of commercial product to CSL Vifor during the three months ended March 31, 2024; (3) clinical compound sales from the Maruishi license agreement during each of the three months ended March 31, 2025 and 2024; and (4) other revenue which represents royalty payments earned by Cara under Vifor Agreement No. 2 and the Maruishi Agreement under the Original HCR Agreement during each of the three months ended March 31, 2025 and 2024. As of March 31, 2025, Cara has not earned any sales-based milestones under its collaboration agreements.

As of March 31, 2025, Cara had license and collaboration agreements with CSL Vifor, Maruishi and CKDP (see Note 18,Subsequent Events). The following table provides amounts included in Cara’s Condensed Consolidated Statements of Comprehensive Loss as revenue for each of the three months ended March 31, 2025 and 2024, respectively:

​​​​​​​
​ · ​ · Three Months Ended March 31,
​20252024
Collaborative revenue​​​​​​
CSL Vifor (KORSUVA injection profit sharing)​$1,198​$788
Total collaborative revenue​$1,198​$788
Commercial supply revenue​​​​​​
CSL Vifor (KORSUVA injection)​$—​$640
Total commercial supply revenue​$—​$640
Clinical compound revenue​​​​​​
Maruishi​$48​$84
Total clinical compound revenue​$48​$84
Other revenue (non-cash)​​​​​​
CSL Vifor (Kapruvia ex-U.S.)​$373​$290
Maruishi​​950​​333
Total other revenue​$1,323​$623

Collaborative revenue

Beginning in April 2022, Cara began recording its share of the profit generated by KORSUVA injection sales by CSL Vifor to third parties in the United States. Under the license agreements with CSL Vifor, KORSUVA injection net sales are calculated by CSL Vifor which are net of discounts, rebates, and allowances. These amounts include the use of estimates and judgments, which could be adjusted based on actual results in the future. Cara records its share of the net profits from the sales of KORSUVA injection in the United States on a net basis (since Cara is not the primary obligor and does not retain inventory risk) and presents the revenue earned each period as collaborative revenue.

For the three months ended March 31, 2025, CSL Vifor recorded net sales of KORSUVA injection in the United States of approximately $2,429, which resulted in Cara’s profit share amount of $1,198. For the three months ended March 31, 2024, CSL Vifor recorded net sales of approximately $1,806, which resulted in Cara’s profit share amount of $788.

Commercial supply revenue

Under the Vifor International Supply Agreement, Cara’s only performance obligation is the delivery of KORSUVA injection to CSL Vifor in accordance with the receipt of purchase orders. Revenue from the sale of commercial supply product to CSL Vifor is recognized as delivery of the product occurs. There wasno commercial supply revenue for the three months ended March 31, 2025. For the three months ended March 31, 2024, Cara had commercial supply revenue of $640 with associated COGS of $620.

Clinical compound revenue

Cara’s only performance obligation under the supply agreement with Maruishi is to deliver clinical compound to Maruishi in accordance with the receipt of purchase orders. During the three months ended March 31, 2025 and 2024, Cara recognized clinical compound revenue of $48 and $84, respectively, from the sale of clinical compound to Maruishi (see Note 18,Subsequent Events).

Other revenue

Cara recorded other non-cash revenue of $1,323 and $623 which represents the royalty payments earned by Cara under Vifor Agreement No. 2 and the Maruishi Agreement during the three months ended March 31, 2025 and 2024, respectively, in conjunction with ex-U.S. sales of KORSUVA/Kapruvia, which is to be remitted to HCR under the terms of the Original HCR Agreement. This non-cash revenue was to be recorded until Cara fulfilled its obligations under the Original HCR Agreement. In connection with the consummation of the Asset Disposition, the Original HCR Agreement was terminated (see Note 9,Royalty Purchase and Sale Agreementand Note 18*, Subsequent Events*).

Contract balances

As of March 31, 2025 and December 31, 2024, Cara recorded accounts receivable, net – related party of $1,229 and $407, respectively, which primarily related to its profit-sharing revenue from sales of KORSUVA injection in the United States by CSL Vifor and royalty payments from CSL Vifor for the 2025 period, and royalty payments from CSL Vifor in the 2024 period. Cara also recorded $950 and $1,047 within other receivables which primarily related to royalty payments from Maruishi as of March 31, 2025 and December 31, 2024, respectively. There wereno other contract assets or contract liabilities related to the CSL Vifor, Maruishi and CKDP agreements as of March 31, 2025 and December 31, 2024.

Cara routinely assessed the creditworthiness of its license and collaboration partners. Cara had not experienced any losses related to receivables from its license and collaboration partners as of March 31, 2025 and December 31, 2024. In connection with the consummation of the Asset Disposition, the Original HCR Agreement was terminated and future payments to HCR, including other non-cash revenue earned in the first quarter of 2025, would be made by CSL Vifor (see Note 18,Subsequent Events).

  1. Net Loss Per Share

Basic net loss per share is computed by dividing net loss by the weighted-average number of shares of common stock outstanding. Diluted net loss per share includes the potential dilutive effect of common stock equivalents as if such securities were exercised during the period, when the effect is dilutive. Common stock equivalents may include outstanding stock options or restricted stock units, which are included using the treasury stock method when dilutive. For each of the three months ended March 31, 2025 and 2024, Cara excluded the effects of potentially dilutive shares that were outstanding during those respective periods from the denominator as their inclusion would be anti-dilutive due to Cara’s net losses during those periods.

The denominators used in the net loss per share computations are as follows:

​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months Ended · ​
​ · ​ · March 31, · ​
​20252024
Basic:
Weighted average common shares outstanding1,524,1161,516,336
Diluted:​
Weighted average common shares outstanding - Basic1,524,1161,516,336
Common stock equivalents*——
Denominator for diluted net loss per share1,524,1161,516,336
*No amounts were considered as their effects would be anti-dilutive.

Basic and diluted net loss per share are computed as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months Ended · ​
​ · ​ · March 31, · ​
​ · 2025 · 2024
Net loss - basic and diluted​$(4,906)​$(30,696)​
Weighted-average common shares outstanding:​​​​
Basic and diluted​1,524,116​1,516,336​
Net loss per share, basic and diluted:​$(3.22)​$(20.24)​

As of March 31, 2025,113,487 stock options and 25,846 restricted stock units were outstanding, which could potentially dilute basic earnings per share in the future, but were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive as a result of the net loss for the period.

As of March 31, 2024,244,904 stock options and 6,952 restricted stock units were outstanding, which could potentially dilute basic earnings per share in the future, but were not included in the computation of diluted net loss per share because to do so would have been anti-dilutive as a result of the net loss for the period.

  1. Stock-Based Compensation

2019 Inducement Plan

In October 2019, Cara’s Board of Directors adopted the 2019 Inducement Plan (the “2019 Plan”) which was a non-stockholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq Listing Rule 5635(c)(4) (“Rule 5635”) for the purpose of awarding (i) non-statutory stock options, (ii) restricted stock awards, (iii) restricted stock unit awards, (iv) other stock awards (collectively, the Inducement Awards) to new employees of Cara, as inducement material to such new employees entering into employment with Cara. In November 2019, Cara filed a Registration Statement on Form S-8 with the SEC covering the offering of up to 8,333 shares of its common stock, par value$0.001, pursuant to Cara’s 2019 Plan. Initial grants of Inducement Awards made to employees vested as to 25% on the first anniversary of the date of grant and the balance ratably over the next 36 months and subsequent grants vested monthly over a period offour years from the grant date.

2014 Equity Incentive Plan

Cara’s 2014 Equity Incentive Plan (the “2014 Plan”) was administered by Cara’s Board of Directors or a duly authorized committee thereof, referred to as the Plan administrator. The 2014 Plan provided for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance stock awards and other forms of equity compensation, collectively referred to as Stock Awards. Additionally, the 2014 Plan provided for the grant of performance cash awards. Incentive stock options could be granted only to employees. All other awards could be granted to employees, including officers, non-employee directors, and consultants. No incentive stock options could be granted under the 2014 Plan after the tenth anniversary of the effective date of the 2014 Plan. Stock Awards granted under the 2014 Plan vested at the rate specified by the Plan administrator. Initial grants of Stock Awards made to employees and non-employee consultants generally vested as to 25% on the first anniversary of the date of grant and the balance ratably over the next 36 months and subsequent grants generally vested monthly over a period offour years from the grant date, or upon the probable achievement of corporate goals. Stock options initially granted to members of Cara’s Board of Directors generally vested over a period ofthree years in equal quarterly installments from the date of the grant, subject to the option holder’s continued service as a director through such date. Subsequent grants to directors that were made automatically at Annual Meetings of Stockholders vested fully on the earlier of the first anniversary of the date of grant and the next Annual Meeting of Stockholders. The Plan administrator determined the term of Stock Awards granted under the 2014 Plan up to a maximum often years. The maximum number of shares that could be issued pursuant to the exercise of incentive stock options under the 2014 Plan was 833,333.

Restricted Stock Units

Under the 2014 Plan, there wereno restricted stock units granted during each of the three months ended March 31, 2025 and 2024. No restricted stock units were granted under the 2019 Inducement Plan during the three months ended March 31, 2025 and 2024.

As of March 31, 2025, Cara’s restricted stock units consisted of time-based restricted stock units. All performance-based restricted stock units either vested or were forfeited in 2024. For time-based restricted stock units, Cara recognized compensation expense associated with these restricted stock units ratably over the award’s vesting period following the grant date. For performance-based restricted stock units, vesting was contingent on the achievement of certain performance targets, subject to the recipient’s continuous service through each performance target. Recognition of compensation expense associated with these performance-based awards began when, and to the extent, the performance criteria were probable of achievement and the employee had met the service conditions.

During the three months ended March 31, 2025 and 2024, Cara recognized compensation expense relating to restricted stock units as follows:

​​​​​​​
​ · ​ · Three Months Ended
​ · ​ · March 31,
​ · 2025 · ​ · ​ · 2024
Research and development$—​$255
General and administrative​​326​​1,357
Total restricted stock unit expense$326​$1,612

A summary of restricted stock unit activity related to employees and non-employee members of Cara’s Board of Directors as of and for the three months ended March 31, 2025 is presented below:

​ · ​ · ​ · ​ · ​ · ​
​​​​Weighted
​​Number of​Average Grant
​ · Units · Date Fair Value
Outstanding, December 31, 202426,638​$52.53
Awarded—​—
Vested and released(792)​447.95
Forfeited—​—
Outstanding, March 31, 202525,846​$40.39
Restricted stock units exercisable (vested and deferred), March 31, 2025—​​​

Stock Options

Under the 2014 Plan, there wereno stock options granted during the three months ended March 31, 2025. Cara granted 52,087 stock options during the three months ended March 31, 2024. No stock options were granted under the 2019 Inducement Plan during the three months ended March 31, 2025 and 2024. There wasno stock compensation expense recognized for the stock options granted during the three months ended March 31, 2024 as these were performance-based options that were not probable of achievement as of March 31, 2024. The fair values of stock options granted during the three months ended March 31, 2024 were estimated as of the dates of grant using the Black-Scholes option pricing model with the following assumptions:

​ · ​ · ​ · ​ · ​ · ​
​​Three Months Ended​
​​March 31,​
​ · 2025 · 2024
Risk-free interest rate—​4.12%
Expected volatility—​89.6%
Expected dividend yield—​0%
Expected life of employee and Board options (in years)—​6.25

The weighted-average grant date fair value per share of options granted to employees and non-employee members of Cara’s Board of Directors for their Board service during the three months ended March 31, 2024 was $27.36. No options were granted to non-employee consultants during the three months ended March 31, 2025 and 2024.

During the three months ended March 31, 2025 and 2024, Cara recognized compensation expense relating to stock options as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months Ended · ​
​ · ​ · March 31, · ​
​ · 2025 · 2024
Research and development​$—​$504​
General and administrative​1,100​1,229​
Total stock option expense​$1,100​$1,733​

A summary of stock option award activity related to employees and non-employee members of Cara’s Board of Directors as of and for the three months ended March 31, 2025 is presented below:

​ · ​ · ​ · ​ · ​ · ​ · ​
​​​​Weighted​
​​Number of​Average Exercise​
​ · Shares · Price
Outstanding, December 31, 2024113,487​$319.80
Granted—​—
Exercised—​—
Forfeited—​—
Expired—​—
Outstanding, March 31, 2025113,487​$319.80​
Options exercisable, March 31, 202564,989​​​​

Cara does not expect to realize any tax benefits from its stock option activity or the recognition of stock-based compensation expense because Cara currently has net operating losses and has a full valuation allowance against its deferred tax assets. Accordingly, no amounts related to excess tax benefits have been reported in cash flows from operations for each of the three months ended March 31, 2025 and 2024.

On April 15, 2025, the Merger was consummated and the Combined Company assumed and approved certain incentive plans. In addition, all remaining unvested Cara options and restricted stock units as of March 31, 2025 fully vested on April 15, 2025 (see Note 18,Subsequent Events).

  1. Income Taxes

Cara has recognized a full tax valuation allowance against its deferred tax assets as of March 31, 2025 and December 31, 2024. The tax benefit related to the exercise of stock options is recognized as a deferred tax asset that is offset by a corresponding valuation allowance. As such, Cara’s effective tax rate iszero for each of the three months ended March 31, 2025 and 2024.

Historically, Cara’s benefit from income taxes related to state R&D tax credits exchanged for cash pursuant to the Connecticut R&D Tax Credit Exchange Program, which permits qualified small businesses engaged in R&D activities within Connecticut to exchange their unused R&D tax credits for a cash amount equal to 65% of the value of the exchanged credits. Cara did not exchange its R&D tax credit for cash during the three months ended March 31, 2025 and 2024. Therefore, there wasno benefit from income taxes for either of the three months ended March 31, 2025 and 2024.

  1. Commitments and Contingencies

Merger Proceedings

Two lawsuits were filed in the Supreme Court of the State of New York, County of New York, on March 5 and March 6, 2025 by two purported stockholders of Cara in connection with the Merger. The lawsuits are captioned Joseph Clark v. Cara Therapeutics, Inc., et al., No. 651260/2025 (the “Clark Complaint”), and Michael Kent v. Cara Therapeutics, Inc., et al., No. 651272/2025 (the “Kent Complaint” and, together with the Clark Complaint, the “Complaints”). Both Complaints named as defendants Cara and the members of the Cara board of directors as defendants. The plaintiffs contended that the Proxy Statement/Prospectus omitted or misrepresented material information regarding the Merger, rendering the Proxy Statement/Prospectus false and misleading, and assert claims under New York state law.

Between December 20, 2024 and March 19, 2025, Cara received thirteen demands andthree draft complaints from purported stockholders of Cara (collectively, the “Demands”) making substantially similar allegations as in the Complaints regarding the disclosures in the Proxy Statement/Prospectus related to the Merger and assert claims for violations of Sections 14(a) and 20(a) of the Securities Exchange Act of 1934.

The Combined Company cannot predict the outcome of any litigation or the Demands. The Combined Company and the individual defendants intend to vigorously defend against the allegations made in the Complaints, the Demands, and any subsequently filed similar actions. It is possible additional lawsuits may be filed or additional demand letters may be received arising out of the Merger. Absent new or significantly different allegations, the Combined Company will not necessarily disclose such additional filings.

Given the early stage of this litigation, at this time, the Combined Company is not in a position to assess the likelihood of any potential loss or adverse effect on its financial condition or to estimate the amount or range of potential losses, if any, from this action.

Other Proceedings

From time to time, the Combined Company may be subject to legal proceedings and claims arising in the ordinary course of its business. The Combined Company is not currently a party or aware of any proceedings that it believes will have, individually or in the aggregate, a material adverse effect on the Combined Company’s business, financial condition or results of operations.

License Agreement with Enteris Biopharma, Inc.

In August 2019, Cara entered into a non-exclusive license agreement (the “Enteris License Agreement”) with Enteris Biopharma, Inc. (“Enteris”), pursuant to which Enteris granted to Cara a non-exclusive, royalty-bearing license, including the right to grant sublicenses, under certain proprietary technology and patent rights related to or covering formulations for oral delivery of peptide active pharmaceutical ingredients with functional excipients to enhance permeability and/or solubility, known as Enteris’s Peptelligence® technology, to develop, manufacture and commercialize products using such technology worldwide, excluding Japan and South Korea.

Cara was also obligated, pursuant to the Enteris License Agreement, to pay Enteris (1) milestone payments upon the achievement of certain development, regulatory and commercial milestones and (2) low-single digit royalty percentages on net sales of licensed products, subject to reductions in specified circumstances. During the three months ended March 31, 2025 and 2024, no milestone payments or royalties were paid to Enteris by Cara in relation to the Enteris License Agreement.

In June 2024, Cara announced its decision to discontinue the clinical program in NP following the outcome from the dose-finding Part A of the KOURAGE-1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with NP.

Manufacturing Agreements

In July 2021, Cara entered into an API Commercial Supply Agreement with Polypeptide Laboratories S.A. (“PPL”) that defines each party’s responsibilities with respect to PPL’s manufacture and supply of the active pharmaceutical ingredient difelikefalin (“API”) for the difelikefalin injection product candidate. Under the API Commercial Supply Agreement, PPL manufactured API at its facility for sale and supply to Cara, in the amounts as set forth in purchase orders to be provided by Cara. Cara was required to purchase its requirements of API for each year of the term of the agreement, based on internal forecasts.

The API Commercial Supply Agreement was to continue until the fifth anniversary of the approval by the FDA of the new drug application for KORSUVA injection, unless the API Commercial Supply Agreement was earlier terminated, and would be automatically be extended for successive five-year periods unless either party gave notice to the other party of its intention to terminate. In connection with the consummation of the Asset Disposition, Cara assigned the API Commercial Supply Agreement to CSL Vifor (see Note 18,Subsequent Events).

In July 2019, Cara entered into a Master Manufacturing Services Agreement (“MSA”) with Patheon UK Limited (“Patheon”). The MSA governed the general terms under which Patheon, or one of its affiliates, would provide non-

exclusive manufacturing services to Cara for the drug products specified by Cara from time to time. Pursuant to the MSA, Cara agreed to order from Patheon at least a certain percentage of its commercial requirements for a product under a related Product Agreement. Each Product Agreement that Cara entered into from time to time would be governed by the terms of the MSA, unless expressly modified in such Product Agreement.

The MSA had an initial term ending December 31, 2024, which automatically renewed after the initial term for successive terms oftwo years until December 31, 2026. In connection with the consummation of the Asset Disposition, Cara assigned the MSA to CSL Vifor (see Note 18,Subsequent Events).

In July 2019, Cara entered intotwo related Product Agreements under the MSA, one with each of Patheon and Patheon Manufacturing Services LLC (“Patheon Greenville”), to govern the terms and conditions of the manufacture of commercial supplies of difelikefalin injection, Cara’s lead product candidate. Pursuant to the Product Agreements, Patheon and Patheon Greenville manufactured commercial supplies of difelikefalin injection at the Monza, Italy and Greenville, North Carolina manufacturing sites, respectively, from active pharmaceutical ingredient supplied by Cara. Patheon and Patheon Greenville were responsible for supplying the other required raw materials and packaging components, and provided supportive manufacturing services such as quality control testing for raw materials, packaging components and finished product.

Restructuring Activity

Cara announced restructuring activities related to workforce reductions in January and June 2024. There wasno additional restructuring expense recorded for the three months ended March 31, 2025, and restructuring expenses of $2,401 were recorded for the three months ended March 31, 2024. As of December 31, 2024, $50 remained to be paid under Cara’s restructuring provision. As of March 31, 2025, there wereno amounts remaining to be paid under Cara’s restructuring provision.

Operating Lease

Cara’s corporate office lease agreement that was entered into in May 2023 for new principal office space in Stamford, Connecticut was terminated on November 1, 2024. As a result, there wereno operating lease right-of-use (“ROU”) assets or operating lease liabilities as of March 31, 2025 and December 31, 2024 due to the termination of the lease.

During the three months ended March 31, 2024, interest expense was calculated using the effective interest method, and any right-of-use asset was amortized on a straight-line basis, and both were recorded as lease expense. As a result, lease expense of $269 for this former lease was recorded for the three months ended March 31, 2024, consisting of $173 relating to R&D lease expense and $96 relating to G&A lease expense.

Other information related to the former lease was as follows:

​ · ​ · ​ · ​ · ​ · ​ · ​ · ​
​ · ​ · Three Months EndedMarch 31, · ​
​ · 2025 · 2024 · ​
Cash paid for amounts included in the measurement of lease liabilities: · ​ · ​ · ​
Operating cash outflows relating to operating leases​$—​$—​
ROU assets obtained in exchange for new operating lease liabilities​$—​$—​
Remaining lease term - operating leases (years)​—​10.6​
Discount rate - operating leases​—%​12.8%

There are no other future minimum cash lease payments as the lease agreement was terminated in 2024.

  1. Related Party Transactions

As of March 31, 2025, Vifor International owned 205,465, or 13.5%, of Cara’s common stock. CSL Vifor and its affiliates are considered related parties as of March 31, 2025 and December 31, 2024(see Note 11,Collaboration and Licensing Agreements).

As of March 31, 2025 and December 31, 2024, amounts due from CSL Vifor were$1,229 and$407, respectively, primarily relating toits profit-sharing revenue from sales of KORSUVA injection in the United States by CSL Vifor and royalty payments from CSL Vifor in the current period, and royalty payments from CSL Vifor in the prior period.

Cara’s collaborative revenue of$1,198 and$788 from its share of the profit generated by sales of KORSUVA injection in the United States by CSL Vifor was included within collaborative revenue for the three months ended March 31, 2025 and 2024, respectively.

Sales of KORSUVA injection to CSL Vifor of $640 were included within commercial supply revenue for the three months ended March 31, 2024. The associated COGS for Cara’s commercial supply revenue from CSL Vifor was $620 for the three months ended March 31, 2024.

Cara recorded$373 and $290 as other revenue from its royalty payments from CSL Vifor for the three months ended March 31, 2025 and 2024, respectively.

18. Subsequent Events

Consummation of Merger Agreement

On April 15, 2025, Cara, Merger Sub, and Tvardi consummated the transactions contemplated by the Merger Agreement following a Special Meeting (as described below) of Cara’s stockholders. Effective at 4:01 p.m. Eastern Time on April 15, 2025, Cara effected the 2025 Reverse Stock Split (as described below), and effective at 4:02 p.m. Eastern Time on April 15, 2025, Cara increased its authorized shares of common stock to 150,000,000. Effective at 4:03 p.m. Eastern Time on April 15, 2025, pursuant to the Certificate of Merger, Merger Sub was merged with and into Tvardi and Tvardi became a wholly owned subsidiary of Cara. Effective at 4:04 p.m. Eastern Time on April 15, 2025, Cara changed its name to “Tvardi Therapeutics, Inc.”. Following the completion of the Merger, the business conducted by Cara became primarily the business conducted by Tvardi, which 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.

Under the terms of the Merger, immediately prior to the effective time of the Merger, each share of Tvardi’s preferred stock was converted intoone share of Tvardi’s common stock. At the effective time of the Merger, Cara issued an aggregate of 7,805,161 shares of its common stock to Tvardi’s stockholders and holders of outstanding convertible promissory notes, or the Convertible Notes, of Tvardi, based on (i) an exchange ratio of 0.1341 shares of Cara’s common stock for each share of Tvardi common stock outstanding immediately prior to the Merger, including those shares of common stock issued upon conversion of the Tvardi preferred stock (but excluding shares of Tvardi’s common stock held (a) as treasury stock by Tvardi, (b) by Cara, Merger Sub, or any subsidiary of Cara or Tvardi or (c) as dissenting shares of Tvardi’s common stock) and (ii) the automatic conversion of the Convertible Notes, with an aggregate principal amount of approximately $28,300 and approximately $800 in accrued interest, into shares of Cara’s common stock pursuant to the terms of the Convertible Notes, resulting in approximately 9.4 million shares of the Combined Company’s common stock being issued and outstanding immediately following the effective time of the Merger. Immediately following the Merger, pre-Merger Cara equity holders owned, in the aggregate, approximately 15.4% of the Combined Company’s common stock, pre-Merger Tvardi equity holders owned, in the aggregate, approximately 72.0% of the Combined Company’s common stock, and former holders of Convertible Notes owned, in the aggregate, approximately 12.5% of the Combined Company’s common stock, in each case, calculated on a fully diluted basis.

Further, upon closing of the Merger, certain of the options to purchase Cara’s common stock held by non-executive employees and directors and restricted stock units held by directors fully vested, pursuant to the terms of the Merger Agreement. Additionally, the options and restricted stock units held by Cara’s remaining executives prior to the closing accelerated upon closing, pursuant to change-in-control language within preexisting employment agreements or separation agreements.

The issuance of the shares of Cara’s common stock to the former stockholders of Tvardi and the holders of the Convertible Notes was registered with the SEC on Cara’s Registration Statement on Form S-4 (File No.333-283900), as amended and declared effective by the SEC on February 14, 2025 (the “Registration Statement”).

The shares of Cara’s common stock, which traded on the Nasdaq Capital Market through the close of business on Tuesday, April 15, 2025 under the ticker symbol “CARA,” commenced trading on The Nasdaq Capital Market on a post-2025 Reverse Stock Split adjusted basis under the ticker symbol “TVRD” on April 16, 2025. The Combined Company’s common stock is represented by a new CUSIP number, 140755 307.

The foregoing description of the Merger and the Merger Agreement contained herein does not purport to be complete and is qualified in its entirety by reference to the full text of the Merger Agreement, which was filed as Exhibit 2.1 on the Current Report on Form 8-K filed by Cara on December 18, 2024.

Closing of APA and Asset Disposition

As previously disclosed, on December 17, 2024, the Cara Sellers entered into the APA with Vifor Fresenius Medical Care Renal Pharma, Ltd., a majority-owned, indirect subsidiary of CSL Vifor, pursuant to which, at the consummation of the transaction, Cara Sellers sold to CSL Vifor and CSL Vifor acquired from Cara Sellers certain assets and rights for the development, manufacture and commercialization of difelikefalin as well as certain associated liabilities for a purchase price of $900 (subject to certain adjustments with respect to inventory). The Asset Disposition closed on April 15, 2025.

Pursuant to the APA, in connection with the consummation of the Asset Disposition, CSL Vifor and HCR entered into a letter agreement with Cara providing that CSL Vifor and HCR would enter into an amended and restated purchase agreement to amend and replace the Original HCR Agreement, by and among Cara Royalty Sub, HCRX and HCR. Upon

entering into the amended and restated purchase agreement, effective as of the closing of the Asset Disposition: (i) CSL Vifor became obligated to make certain payments to HCR from and after the date thereof relating to certain revenue and/or royalties from difelikefalin, (ii) each of the Contribution Agreement, the License Agreement and the Pledge Agreement (each as defined in the Original HCR Agreement) were terminated, and (iii) Cara Sellers had no further payment or other obligations to HCR under the Original HCR Agreement. Additionally, pursuant to the APA, at the consummation of the Asset Disposition, Cara paid CSL Vifor $3,000 to compensate CSL Vifor for the estimated incremental future expenses incurred by CSL Vifor as a result of the transfer of the assets acquired and the liabilities assumed by it in connection with the Asset Disposition.

All future payments to HCR subsequent to April 15, 2025, including other non-cash revenue earned by Cara in the first quarter of 2025, will be made by CSL Vifor. As a result, Cara fully reserved for $373 of accounts receivable, net – related party by recording bad debt expense on April 15, 2025 for CSL Vifor, and also fully reserved for $950 of other receivables by recording bad debt expense on April 15, 2025 for Maruishi since Cara will not receive any future revenue payments to pay HCR.

In connection with the consummation of the Merger and Asset Disposition, approximately $2,000 of success and legal fees were paid to Piper Sandler.

Assignment of Difelikefalin Agreements

In connection with the Asset Disposition, Cara assigned the following agreements related to difelikefalin to CSL Vifor:

●License Agreement dated April 4, 2013 and related API supply agreement by and between Cara and Maruishi;
●License and API Supply Agreement effective as of April 16, 2012, as amended on May 1, 2012, by and between Cara and CKDP;
●API Commercial Supply Agreement effective as of July 5, 2021 between Cara and PPL; and
●Master MSA effective as of June 27, 2019 between Cara and Patheon.

The foregoing description of the APA and the Asset Disposition and related transactions does not purport to be complete and is qualified in its entirety by reference to the full text of the APA, which was filed as Exhibit 10.4 to the Current Report on Form 8-K filed by Cara on December 18, 2024.

2025 Reverse Stock Split

As previously disclosed, at a special meeting of Cara’s stockholders held on April 1, 2025 (the “Special Meeting”), Cara’s stockholders approved (i) an amendment to Cara’s amended and restated certificate of incorporation to effect the 2025 Reverse Stock Split and (ii) an amendment to Cara’s amended and restated certificate to increase the authorized number of shares of Cara’s common stock from 16,666,667 shares to 150,000,000 shares. On April 15, 2025, Cara amended its amended and restated certificate of incorporation to (i) effect the 2025 Reverse Stock Split, effective as of 4:01 p.m. Eastern Time on April 15, 2025 and (ii) to increase the authorized number of shares of Cara’s common stock from 16,666,667 shares to 150,000,000 shares, effective as of 4:02 p.m. Eastern Time on April 15, 2025.

As a result of the 2025 Reverse Stock Split, every three shares of Cara’s common stock held by a stockholder immediately prior to the 2025 Reverse Stock Split were combined and reclassified intoone share of Cara’s common stock. As such, immediately following the 2025 Reverse Stock Split, there were approximately 1.5 million shares of Cara’s common stock outstanding.

No fractional shares were issued in connection with the 2025 Reverse Stock Split. Any fractional shares resulting from the 2025 Reverse Stock Split were rounded down to the nearest whole number, and each Cara stockholder who would otherwise be entitled to a fraction of a share of common stock upon the 2025 Reverse Stock Split was entitled to receive a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise have been entitled multiplied by the closing price of Cara’s common stock on April 14, 2025.

On April 15, 2025, Cara also amended its amended and restated certificate of incorporation to effect the Name Change, effective as of 4:04 p.m. Eastern Time on April 15, 2025.

The foregoing descriptions of the certificates of amendment to the amended and restated certificate of incorporation of Cara are not complete and are subject in their entirety by reference to the certificates of amendment, copies of which were filed as Exhibit 3.1, Exhibit 3.2 and Exhibit 3.3, respectively, to the Current Report on Form 8-K filed by Cara on April 15, 2025.

Departure of Officers

On April 15, 2025, effective upon the closing of the Merger, the employment of each of Cara’s President and Chief Executive Officer, Chief Financial Officer, and General Counsel, Secretary and Chief Compliance Officer, respectively, was terminated. In connection with their termination of employment, each entered into side letters with Cara which provided for (i) in the case of the Chief Executive Officer, a lump sum payment equal to 18 months of his current base salary, a lump sum payment equal toone and a half times his 2025 target annual bonus and payment of applicable COBRA premiums for up to 18 months following termination, (ii) in the case of the Chief Financial Officer, a lump sum payment equal to 12 months of his current base salary, a lump sum payment equal to his 2025 target annual bonus and payment of applicable COBRA premiums for up to 12 months following termination, and (iii) in the case of the Chief Compliance Officer, a lump sum payment equal to 12 months of his current base salary, a lump sum payment equal to his 2025 target annual bonus and payment of applicable COBRA premiums for up to 12 months following termination. Each executed a release of claims in favor of Cara as a condition to receiving their respective severance benefits. As a result of the closing of the Merger on April 15, 2025, Cara paid approximately $5,400 in aggregate for severance payments to allten remaining employees of Cara that were terminated at closing, including the Chief Executive Officer, Chief Financial Officer and Chief Compliance Officer above. The Combined Company expects to pay theseten former Cara employees approximately $300 in aggregate for estimated COBRA premiums. The terms of the side letters are pursuant to, and consistent with, the terms of the Cara Therapeutics, Inc. Severance Plan and Form of Participation Agreement, which was filed as Exhibit 10.14 to the Annual Report on Form 10-K filed by Cara on March 1, 2022, and the Chief Executive Officer Employment Agreement, which was filed as Exhibit 10.1 to the Current Report on Form 8-K filed by Cara on November 3, 2021, as applicable.

2018 Equity Incentive Plan

The Combined Company assumed, effective as of the closing of the Merger, the 2018 Equity Incentive Plan of Tvardi (the “2018 Plan”), as well as the outstanding awards granted thereunder, the award agreements evidencing the grants of such awards and the remaining shares available under the 2018 Plan, including any awards granted to the Combined Company’s named executive officers, in each case subject to applicable adjustments in the manner set forth in

the Merger Agreement to such awards. A copy of the 2018 Plan, as well as the forms of option grant notice and option agreement and forms of restricted stock unit grant notice and unit award agreement were filed as Exhibits 10.24, 10.25 and 10.26, respectively, to the Registration Statement on Form S-4 filed with the SEC on December 18, 2024.

2025 Equity Incentive Plan

At the Special Meeting, Cara’s stockholders considered and approved the Combined Company’s 2025 Equity Incentive Plan (the “2025 Plan”), which became effective at the closing of the Merger and following the 2025 Reverse Stock Split. As of the effective time of the Merger, there were 935,554 shares of the Combined 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 Combined Company’s Board of Directors (and without any further action by the Combined 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 Combined 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 Combined Company’s common stock. In the absence of action by the Combined Company’s Board of Directors, no such increase will automatically occur. A copy of the 2025 Plan, forms of option grant notices and option agreements and forms of restricted stock unit grant notice and unit award agreement, was attached to the Current Report on Form 8-K on April 15, 2025 as Exhibits 10.14, 10.15 and 10.16, respectively.

2025 Employee Stock Purchase Plan

At the Special Meeting, Cara’s stockholders considered and approved the Combined Company’s 2025 Employee Stock Purchase Plan (the “2025 ESPP”), which became effective at the closing of the Merger and following the 2025 Reverse Stock Split. As of the effective time of the Merger, there were 93,555 shares of the Combined 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 Combined 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. A copy of the 2025 ESPP was attached to the Current Report on Form 8-K on April 15, 2025 as Exhibit 10.18.

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