# EDGAR Filing Document

**Accession Number:** 0001346830
**File Stem:** 0001104659-25-078665
**Filing Date:** 2025-8
**Character Count:** 18395
**Document Hash:** ff7f2a1524959b56d9dc23dfa2f623cd
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-078665.hdr.sgml**: 20250814

**ACCESSION NUMBER**: 0001104659-25-078665

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250814

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250814

**DATE AS OF CHANGE**: 20250814

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Tvardi Therapeutics, Inc.
- **CENTRAL INDEX KEY:** 0001346830
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36279
- **FILM NUMBER:** 251220007

**BUSINESS ADDRESS:**
- **STREET 1:** 3 SUGAR CREEK CTR. BLVD.
- **STREET 2:** STE 525
- **CITY:** SUGAR LAND
- **STATE:** TX
- **ZIP:** 77478
- **BUSINESS PHONE:** (713) 489-8654

**MAIL ADDRESS:**
- **STREET 1:** 3 SUGAR CREEK CTR. BLVD.
- **STREET 2:** STE 525
- **CITY:** SUGAR LAND
- **STATE:** TX
- **ZIP:** 77478

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cara Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20100721

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Cara Therapeutics Inc
- **DATE OF NAME CHANGE:** 20051213

?xml version='1.0' encoding='ASCII'?

**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) **August 14, 2025**

**TVARDI THERAPEUTICS, INC.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-36279** | **75-3175693** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (IRS Employer<br> Identification No.) |
| **3 Sugar Creek Ctr. Blvd.<br> Suite 525<br> Sugar Land, Texas** |  | **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:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Title of each class** | &nbsp;&nbsp;**Trading<br> Symbol(s)** | &nbsp;&nbsp;**Name of each exchange on which <br> registered** |
| &nbsp;&nbsp;Common Stock, par value $0.001 per share | &nbsp;&nbsp;TVRD | &nbsp;&nbsp;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 August 14, 2025, Tvardi Therapeutics, Inc. (formerly Cara Therapeutics, Inc.) (the "Company") issued a press release announcing its financial results for the fiscal quarter ended June 30, 2025. A copy of the Company's press release dated August 14, 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 made by us, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

**Item 9.01. Financial Statements and Exhibits.**

***(d) Exhibits***

 ****

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| [99.1](tm2523431d1_ex99-1.htm) | [Press release issued on August 14, 2025.](tm2523431d1_ex99-1.htm) |
| 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. | TVARDI THERAPEUTICS, INC. |
| Date: August 14, 2025 | By: | /s/ Imran Alibhai |
|  | Name: | Imran Alibhai |
|  | Title: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](tm2523431d1_ex99-1img001.jpg)

**Tvardi Therapeutics Announces Second Quarter 2025 Results and Provides Business Update**

*On track for multiple Phase 2 data readouts with STAT3 inhibitor, TTI-101, with lead program in IPF expected in Q4 2025*

*Cash runway anticipated to be sufficient to fund operations into Q4 2026*

**HOUSTON, TX – August 14, 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 second quarter ended June 30, 2025, and provided a business update.

**Second Quarter 2025 Highlights:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Announced completion of enrollment in its REVERT IPF clinical trial, a Phase
2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF); topline data on track for Q4 2025.

&nbsp;&nbsp;&nbsp;&nbsp;· Submitted an Investigational New Drug (IND) application for its second clinical
candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· 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,* was presented at the
American Thoracic Society (ATS) 2025 Annual Conference.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;· Completed its merger with Cara Therapeutics, transitioning Tvardi into a
publicly traded company.

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial. These data will offer important additional insights into the safety and efficacy of TTI-101, and, if positive, we believe will further validate our approach of targeting STAT3, a central mediator of fibrosis, to treat patients with IPF."

"In parallel, our Phase 2 REVERT Liver Cancer trial continues to enroll patients, and we remain on track to report topline results in the first half of 2026. Prior interim data from this ongoing study demonstrated clinically meaningful activity of TTI-101 as both monotherapy and in combination with established anti-cancer agents across treatment lines."

"Importantly, we are well-financed through these potential value inflection points, and into Q4 of next year. We believe we are very well positioned to bring meaningful innovation to patients living with fibrosis-driven diseases while creating significant value for our company."

**Upcoming Milestones:**

&nbsp;&nbsp;&nbsp;&nbsp;· Data from the company's ongoing REVERT IPF Phase 2 clinical trial of
TTI-101 anticipated in 4Q 2025

&nbsp;&nbsp;&nbsp;&nbsp;· Preliminary topline data from the company's ongoing REVERT Liver Cancer
Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026

![](tm2523431d1_ex99-1img001.jpg)

**Second Quarter 2025 Financial Results**

**Research and development expenses** for the three months ended June 30, 2025, were $5.8 million as compared to $6.5 million for the comparable period in 2024. The decrease of $0.7 million was primarily driven by clinical, pre-clinical, and CMC costs associated with TTI-101.

**General and administrative expenses** for the three months ended June 30, 2025, were $3.1 million as compared to $650,000 for the comparable period in 2024. The increase of $2.4 million was primarily driven by increases in professional fees of $1.6 million, attributable to increased legal, accounting and audit fees incurred as a result of the merger. The remaining increase was attributable to increases in personnel costs, insurance costs, and other costs.

**Net income** for the three months ended June 30, 2025, was $4.2 million as compared to a net loss of $7.0 million for the comparable period in 2024. The improvement in net income was due primarily to a $12.8 million remeasurement gain on Tvardi's Convertible Notes recognized in the second quarter of 2025.

**Basic and diluted net income (loss) per share** attributable to common shareholders for the three months ended June 30, 2025, were a net gain of $0.51 and net loss of $1.00, respectively, compared to a net loss of $2.71 on a basic and diluted basis for the comparable period in 2024.

**Cash, cash equivalents and short-term investments** as of June 30, 2025, were $41.0 million, as compared to $31.6 million as of December 31, 2024.

**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.

![](tm2523431d1_ex99-1img001.jpg)

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 anticipated cash runway; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, and Tvardi's other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC's website at <u>www.sec.gov</u>. 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.

![](tm2523431d1_ex99-1img001.jpg)

**Contacts:**

**For Tvardi:**

Tvardi Investor Relations

<u>ir@tvardi.com</u>

PJ Kelleher

LifeSci Advisors

617-430-7579

<u>pkelleher@lifesciadvisors.com</u>

![](tm2523431d1_ex99-1img001.jpg)

**TVARDI THERAPEUTICS**

**Consolidated Balance Sheets**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **As of June 30,** | **As of December 31,** |
|  | **2025** | **2024** |
| **Assets** |  |  |
| Current assets: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $20648 | $31614 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Short-term investments | 20346 |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses and other current assets | 2136 | 72 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | 43130 | 31686 |
| Property and equipment, net | 68 | 84 |
| Intangible assets, net | 354 | 385 |
| Operating lease right-of-use assets | 181 | 216 |
| Deferred offering costs |  | 2811 |
| Other non-current assets | 17 | 17 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total assets | $43750 | $35199 |
| **Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit)** |  |  |
| Current liabilities: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accounts payable | $2425 | 2186 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses | 8144 | 8078 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Operating lease liabilities, current portion | 109 | 103 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | 10678 | 10367 |
| Operating lease liabilities, net of current portion | 145 | 201 |
| Convertible Notes |  | 30259 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities | 10823 | 40827 |
| Commitments and contingencies (Note 13) |  |  |
| Redeemable convertible preferred stock (Series A, B), $0.001 par value; 0 shares and 29,723,540 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 0 shares and 3,963,910 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively; aggregate liquidation preference of $0 and $85,902 as of June 30, 2025 and December 31, 2024, respectively |  | 85503 |
| Stockholders' Equity (Deficit): |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Common stock, $0.001 par value; 150,000,000 shares and 58,251,629 shares authorized as of June 30, 2025 and December 31, 2024, respectively; 9,373,433, and 2,574,767 shares issued and outstanding as of June 30, 2025 and December 31, 2024, respectively | 9 | 2 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Additional paid-in capital | 130579 | 1103 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive loss | (13) |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated deficit | (97648) | (92236) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total stockholders' equity (deficit) | 32927 | (91131) |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total liabilities, redeemable convertible preferred stock, and stockholders' equity (deficit) | $43750 | $35199 |

---

![](tm2523431d1_ex99-1img001.jpg)

**TVARDI THERAPEUTICS**

**Consolidated Statement of Operations**

**(Unaudited)**

---

| | | |
|:---|:---|:---|
|  | **For the Three Months Ended <br> June 30,** | **For the Three Months Ended <br> June 30,** |
|  | **2025** | **2024** |
| Operating expenses: |  |  |
| &nbsp;&nbsp;&nbsp;Research and development | $5806 | $6531 |
| &nbsp;&nbsp;&nbsp;General and administrative | 3063 | 650 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | 8869 | 7181 |
| Loss from operations | (8869) | (7181) |
| Interest income | 377 | 206 |
| Other income, net | 12659 |  |
| Net income (loss) | $4167 | $(6975) |
| Net income (loss) per share attributable to common stockholders: |  |  |
| Basic | $0.51 | $(2.71) |
| Diluted | $(1.00) | $(2.71) |
| Weighted-average common shares outstanding: |  |  |
| Basic | 8246582 | 2574767 |
| Diluted | 8455223 | 2574767 |
| Comprehensive income (loss): |  |  |
| &nbsp;&nbsp;&nbsp;Net income (loss) | $4167 | $(6975) |
| &nbsp;&nbsp;&nbsp;Unrealized loss on short-term investments | (15) |  |
| Comprehensive income (loss) | $4152 | $(6975) |

---