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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) May 12, 2025
TVARDI THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36279 | 75-3175693 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
||
|
3 Sugar Creek Ctr. Blvd. |
77478 | |||
| (Address of principal executive offices) | (Zip Code) |
Registrant's telephone number, including area code: (713) 489-8654
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | TVRD | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
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 | |
Exhibit 16.1
May 13, 2025
Securities and Exchange Commission
100 F Street, N.E.
Washington, DC 20549
Commissioners:
We have read the Form 8-K dated May 13, 2025, of Tvardi Therapeutics, Inc. and are in agreement with the statements contained in Item 4.01(a) therein. We have no basis to agree or disagree with other statements of the registrant contained therein.
/s/ Ernst & Young LLP
Ernst & Young LLP
Stamford, Connecticut
Exhibit 99.1
Tvardi Therapeutics Announces First Quarter 2025 Results and Provides Business Update
Completed merger with Cara Therapeutics; cash, cash equivalents and short-term investments at closing anticipated to be sufficient to fund operations into 2H 2026
On track for multiple Phase 2 data readouts with STAT3 inhibitor, TTI-101, with lead program in IPF expected in 2H 2025
HOUSTON, TX – May 13, 2025 - Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today announced its financial and operating results for the first quarter ended March 31, 2025, and provided a business update.
First Quarter 2025 and Subsequent Period Highlights:
| · | Tvardi completed its merger with Cara Therapeutics. |
| o | Tvardi received approximately $23.8 million in net cash from Cara in connection with the closing of the merger. This capital augments the previously announced December 2024 private placement financing of approximately $28.3 million from a syndicate of new and existing institutional investors. |
| · | Announced that an abstract, entitled, Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, will be presented at the upcoming American Thoracic Society 2025 Annual Conference, which is being held May 16-21, 2025 in San Francisco. | |
| · | Announced that results from the first-in-human Phase 1 study of TTI-101 in patients with advanced solid tumors were published in the journal Clinical Cancer Research. |
Dr. Imran Alibhai, Chief Executive Officer of Tvardi, stated, “While it has only been a few weeks since we completed our merger with Cara Therapeutics, our Nasdaq listing has heightened our visibility and potential access to capital. With the cash on our balance sheet, we believe we are well financed through meaningful value inflection points, including anticipated Phase 2 readouts of our lead program in idiopathic pulmonary fibrosis (IPF) as well as our hepatocellular carcinoma program. We expect that our anticipated cash runway, as of the closing of the merger, will be sufficient to fund our operations approximately one year post data readouts in IPF, into the second half of 2026.”
Upcoming Milestones:
| · | Investigational New Drug (IND) submission planned for its second clinical candidate, TTI-109, in 1H 2025 | |
| · | Data from the company’s ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 2H 2025 | |
| · | Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026 |
About Tvardi Therapeutics
Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter).
Cautionary Statement Regarding Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials; its anticipated cash runway; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Registration Statement on Form S-4, as amended (File No. 333-283900) initially filed with the Securities and Exchange Commission (the “SEC”) on December 18, 2024 and declared effective by the SEC on February 14, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
For Tvardi:
Tvardi Investor Relations
ir@tvardi.com
PJ Kelleher
LifeSci Advisors
617-430-7579
pkelleher@lifesciadvisors.com