Tvardi Therapeutics Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits
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Item 2.02. Results of Operations and Financial Condition.
On May 13, 2025, Tvardi Therapeutics, Inc. (formerly Cara Therapeutics, Inc.) (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended March 31, 2025. A copy of the Company’s press release dated May 13, 2025 is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
The information contained herein and the accompanying Exhibit 99.1 is being furnished under “Item 2.02 Results of Operations and Financial Condition” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended, nor shall it be deemed incorporated by reference in any filing with the Securities and Exchange Commission (the “SEC”) made by us, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 4.01. Changes in Registrant’s Certifying Accountant.
(a) Dismissal of Independent Registered Public Accounting Firm
On May 12, 2025, the Audit Committee (the “Audit Committee”) of the Board of Directors of the Company dismissed Ernst & Young LLP (“EY”) as the Company’s independent registered public accounting firm, with such dismissal to become effective immediately following the filing of the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 with the SEC (the “Effective Time”).
EY’s audit reports on the Company’s consolidated financial statements as of and for the years ended December 31, 2024 and 2023 did not contain an adverse opinion or a disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles.
During the Company’s fiscal years ended December 31, 2024 and 2023, and the subsequent interim period through May 12, 2025: (1) there were no “disagreements” (as defined in Item 304(a)(1)(iv) of Regulation S-K and the related instructions to Item 304) with EY on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of EY, would have caused EY to make reference to the subject matter of such disagreements in connection with its reports on the consolidated financial statements for such periods and (2) there were no “reportable events” (as defined in Item 304(a)(1)(v) of Regulation S-K).
The Company provided EY with a copy of this report prior to its filing with the SEC and requested that EY furnish the Company with a letter addressed to the SEC stating whether EY agrees with the statements made by the Company in this report and, if not, stating the respects, if any, in which EY does not agree with such statements. A copy of the letter from EY is filed with this Current Report on Form 8-K as Exhibit 16.1.
(b) Engagement of New Independent Registered Public Accounting Firm
On May 12, 2025, the Audit Committee approved Deloitte & Touche LLP (“Deloitte”) as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2025. On May 13, 2025, Deloitte was engaged as the Company’s independent registered public accounting firm. Deloitte served as the independent registered public accounting firm of Legacy Tvardi prior to the consummation of the merger of Legacy Tvardi with the Delaware corporation formerly known as “Cara Therapeutics, Inc.”
During the Company’s fiscal years ended December 31, 2024 and 2023, and the subsequent interim period through May 13, 2025, neither the Company nor anyone acting on its behalf consulted with Deloitte regarding: (i) the application of accounting principles to a specified transaction, either completed or proposed; or the type of audit opinion that might be rendered on the Company’s financial statements, and neither a written report nor oral advice was provided to the Company that Deloitte concluded was an important factor considered by the Company in reaching a decision as to the accounting, auditing or financial reporting issue; or (ii) any matter that was either the subject of a “disagreement” within the meaning of Item 304(a)(1)(iv) of Regulation S-K and the related instructions to Item 304 or a “reportable event” within the meaning of Item 304(a)(1)(v) of Regulation S-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 16.1 | Letter from Ernst & Young LLP to the SEC dated May 13, 2025. | |
| 99.1 | Press release issued on May 13, 2025. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TVARDI THERAPEUTICS, INC. | ||
| Date: May 13, 2025 | By: | /s/ Imran Alibhai |
| Name: | Imran Alibhai | |
| Title: | Chief Executive Officer | |