Form 8-K

8-K — Tvardi Therapeutics, Inc.

Accession: 0001104659-26-037724

Filed: 2026-03-31

Period: 2026-03-31

CIK: 0001346830

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

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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)

March 31, 2026

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.

Suite 525

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:

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 ¨

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 March 31, 2026, Tvardi

Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results and business highlights for the

fiscal quarter and year ended December 31, 2025. A copy of the Company’s press release dated March 31, 2026 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

Press release issued on March 31, 2026.

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: March 31, 2026

By:

/s/ Imran Alibhai

Name:

Imran Alibhai

Title:

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2610603d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Tvardi Therapeutics Announces

Fourth Quarter and Full-Year 2025 Results and Provides Business Update

Results from healthy volunteer study of

next-generation STAT3 inhibitor, TTI-109, on track for Q2 2026

Topline data from Phase 2 trial of TTI-101

in hepatocellular carcinoma (HCC) are anticipated in H2 2026

Cash runway expected to be sufficient

to fund operations into Q4 2026 after clinical readouts

HOUSTON, TX – March

31, 2026 - 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 inflammatory and proliferative diseases, today announced

its financial and operating results for the fourth quarter and full-year ended December 31, 2025, and provided a business update.

Recent Highlights:

· Additional

analysis from the REVERT IPF Phase 2 trial demonstrated that TTI-101 was associated with

a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for placebo, as well

as a 4.5-fold greater decline in IL-6, a central STAT3-driven inflammatory cytokine. These

findings are consistent with preclinical data demonstrating reductions in established fibrosis

and inflammatory signaling across multiple validated disease models.

· The

healthy volunteer study of its next-generation STAT3 inhibitor, TTI-109, is ongoing, with

topline data anticipated in the second quarter of 2026.

· The

ongoing Phase 1b/2 REVERT LIVER CANCER trial will report topline results in the second half

of 2026 to allow the data additional time to mature. This timing adjustment is intended to

enhance the depth of insights gleaned from the program, including longitudinal and translational

assessments, characterization of durability and dose optimization (including the addition

of up to 15 participants in the monotherapy arm to explore once-a-day dosing), to better inform

subsequent development and regulatory strategy.

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “We

entered 2026 with line-of-site to two significant clinical milestones: 1) healthy volunteer data from our next-generation STAT3 inhibitor,

TTI-109, in the second quarter of this year, and 2) topline data from our ongoing Phase 2 trial of TTI-101 in HCC, which we anticipate

in the second half.”

“Further analysis of data from our Phase 2 IPF trial of TTI-101

that we announced in October revealed compelling trends. These data give us optimism for TTI-109, which has been developed to enhance

TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability.”

“At the same time, we eagerly await data from our ongoing Phase

2 REVERT LIVER CANCER trial, with a data readout expected in the second half of this year to allow for further data maturation. Interim

results from this study have already shown clinically meaningful activity of TTI-101 both as monotherapy and in combination with established

anti-cancer agents across treatment lines, and we believe the broader dataset will better position us to define the optimal development

path and regulatory strategy for this important program.”

“I believe we are well positioned to continue to advance these

promising molecules, potentially offering new hope to patients requiring new, more effective treatment options while creating enduring

value for our company,” Dr. Alibhai concluded.

Upcoming Milestones:

· Preliminary

topline data from a healthy volunteer study of the company’s next-generation STAT3

inhibitor, TTI-109, anticipated in the second quarter of 2026

· Preliminary

topline data from the company’s ongoing REVERT LIVER CANCER Phase 1b/2 clinical trial

of TTI-101, anticipated in the second half of 2026

Fourth Quarter and Full-Year 2025 Financial Results

Research and development expenses for the three

months ended December 31, 2025, were $5.5 million as compared to $8.6 million for the comparable period in 2024. For the full year 2025,

research and development expenses were $18.0 million, as compared to $23.7 million for the full year 2024. The decrease was primarily

driven by declining clinical costs associated with TTI-101 offset by an increase in TTI-109 developmental costs.

General and administrative expenses were $2.1 million

for the three months ended December 31, 2025, as compared to $2.2 million for the three months ended December 31, 2024. For the full

year 2025, general and administrative expenses were $8.7 million, as compared to $4.5 million for the full year 2024. The increase was

primarily driven by increases in professional fees, attributable to increased legal, accounting and audit fees incurred as a result of

the merger with Cara Therapeutics and subsequent filings as a public company.

Net loss for the three months ended December 31,

2025, was $7.3 million, as compared to a net loss of $12.7 million for the comparable period in 2024. For the full year 2025, net loss

was $18.2 million, as compared to a net loss of $29.4 million for the full year 2024.

Basic and diluted net loss per share attributable

to common shareholders for the three months ended December 31, 2025, were a net loss of $(0.78) on a basic and diluted basis, compared

to a net loss of $(4.94) on a basic and diluted basis for the comparable period in 2024. For the full year 2025, basic and diluted net

loss attributable to common stockholders were $(2.46) and $(3.26), respectively, as compared to basic and diluted loss attributable to

common stockholders of $(11.42) for the full year 2024.

Cash, cash equivalents and short-term investments

as of December 31, 2025, were $30.8 million, as compared to $31.6 million as of December 31, 2024. Tvardi anticipates that its current

cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 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 inflammatory and proliferative diseases

with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled, proliferation, survival

and immune dysregulation. 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 clinical trials with TTI-101 in hepatocellular carcinoma (NCT05440708) and TTI-109

in healthy volunteers. 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 and anticipated timing of reporting data from such trials;

potential indications for its product candidates; 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 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

September 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 www.sec.gov. All forward-looking statements contained in

this press release speak only as of the date on which they were made. The 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

TVARDI THERAPEUTICS

Consolidated Balance Sheets

(unaudited)

As of December 31,

2025

2024

Assets

Current assets:

Cash and cash equivalents

$ 20,734

$ 31,614

Short-term investments

10,077

—

Prepaid expenses and other current assets

727

Total current assets

31,538

31,686

Property and equipment, net

Intangible assets, net

322

385

Operating lease right-of-use assets

144

216

Deferred offering costs

—

2,811

Other non-current assets

Total assets

$ 32,073

$ 35,199

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Equity (Deficit)

Current liabilities:

Accounts payable

$ 3,219

2,186

Accrued expenses

7,707

8,078

Operating lease liabilities, current portion

116

103

Total current liabilities

11,042

10,367

Operating lease liabilities, net of current portion

201

Convertible Notes

—

30,259

Total liabilities

11,127

40,827

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 December 31, 2025 and 2024, respectively; 0 shares and 3,963,910 shares issued and outstanding as of December 31, 2025 and 2024, respectively; aggregate liquidation preference of $0 and $85,902 as of December 31, 2025 and 2024, respectively

—

85,503

Stockholders’ Equity (Deficit):

Common stock, $0.001 par value; 150,000,000 shares and 58,251,629 shares authorized as of December 31, 2025 and 2024, respectively; 9,381,344, and 2,574,767 shares issued and outstanding as of December 31, 2025 and 2024, respectively

Additional paid-in capital

131,379

1,103

Accumulated other comprehensive income

—

Accumulated deficit

(110,450 )

(92,236 )

Total stockholders’ equity (deficit)

20,946

(91,131 )

Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)

$ 32,073

$ 35,199

TVARDI THERAPEUTICS

Consolidated Statement of Operations

(unaudited)

For the Three Months Ended

December 31,

For the Twelve Months Ended

December 31,

2025

2024

2025

2024

Operating expenses:

Research and development

$ 5,491

$ 8,603

$ 18,011

$ 23,650

General and administrative

2,096

2,199

8,737

4,457

Total operating expenses

7,587

10,802

26,748

28,107

Loss from operations

(7,587 )

(10,802 )

(26,748 )

(28,107 )

Interest income

312

132

1,375

747

Other income, net

(2,037 )

7,159

(2,037 )

Net loss

$ (7,275 )

$ (12,707 )

$ (18,214 )

$ (29,397 )

Net loss per share attributable to common stockholders:

Basic

$ (0.78 )

$ (4.94 )

$ (2.46 )

$ (11.42 )

Diluted

$ (0.78 )

$ (4.94 )

$ (3.26 )

$ (11.42 )

Weighted-average common shares outstanding:

Basic

9,380,819

2,574,233

7,419,060

2,574,233

Diluted

9,380,819

2,574,767

7,783,182

2,574,233

Comprehensive loss:

Net loss

$ (7,275 )

$ (12,707 )

$ (18,214 )

$ (29,397 )

Unrealized gain on short-term investments

Comprehensive loss

$ (7,274 )

$ (12,707 )

$ (18,206 )

$ (29,397 )

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