Form 8-K

8-K — Tvardi Therapeutics, Inc.

Accession: 0001104659-26-057524

Filed: 2026-05-08

Period: 2026-05-08

CIK: 0001346830

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

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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 8, 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 May 8, 2026, Tvardi Therapeutics,

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

ended March 31, 2026. A copy of the Company’s press release dated May 8, 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 May 8, 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: May 8, 2026

By:

/s/ Imran Alibhai

Name:

Imran Alibhai

Title:

Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2613977d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Tvardi Therapeutics Announces First Quarter

2026 Results and Provides Business Update

Topline results from healthy volunteer study

and clinical development strategy for next-generation STAT3 inhibitor, TTI-109, anticipated in June

Topline data from Phase 2 trial of TTI-101

in hepatocellular carcinoma (HCC) on track for 2H 2026

Cash runway expected to be sufficient to fund

operations through clinical readouts and into Q4 2026

HOUSTON, TX – May 8,

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 reported

its financial and operating results for the first quarter ended March 31, 2026, and provided a business update.

Recent Progress and Upcoming Catalysts:

· TTI-109

(Healthy Volunteer Study): Study ongoing with topline data anticipated in June 2026.

The Company plans to announce the clinical development strategy based on these results.

· TTI-101

(HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track to report topline

results in 2H 2026.

· TTI-101

(IPF – REVERT IPF study additional analyses): Phase 2 trial showed that TTI-101 was

associated with a 9.4% baseline-weighted reduction in fibrosis score compared to 2.4% for

placebo. Treatment with TTI-101 was also associated with a 4.5-fold greater decline in IL-6,

a central STAT3-driven inflammatory cytokine.

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

are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results

are expected to inform our future clinical development strategy.”

“TTI-109 is designed to build on the preclinical and clinical

activity observed with TTI-101 while potentially offering improved tolerability through its prodrug profile and enabling broader development

across inflammatory and proliferative diseases driven by STAT3.”

“In parallel, we remain on track to report topline data from

our ongoing Phase 2 REVERT LIVER CANCER trial in the second half of this year. Prior interim findings demonstrated clinically meaningful

activity across treatment settings, and we look forward to evaluating the full dataset.”

“We continue to make significant progress advancing both programs,

providing line of sight to two near-term value inflection points,” Dr. Alibhai concluded.

Key Upcoming Milestones:

· June 2026:

TTI-109 Phase 1 healthy volunteer topline data and clinical development strategy

· 2H

2026: TTI-101 Phase 1b/2 HCC topline data

First Quarter 2026 Financial Results

Research and development expenses for the three months ended

March 31, 2026, were $4.9 million as compared to $3.1 million for the comparable period in 2025. The increase was primarily driven

by higher TTI-109 developmental costs, partly offset by declining clinical costs associated with TTI-101.

General and administrative expenses were $2.1 million for the

three months ended March 31, 2026, as compared to $1.2 million for the three months ended March 31, 2025. The increase was

primarily driven by higher personnel costs, including stock-based compensation, and professional fees, including costs associated with

being a publicly traded company.

Net loss for the three months ended March 31, 2026, was

$6.8 million, as compared to a net loss of $9.6 million for the comparable period in 2025.

Basic and diluted net loss per share attributable to common

shareholders for the three months ended March 31, 2026, were a net loss of $(0.73), compared to a net loss of $(3.72) for the comparable

period in 2025.

Cash, cash equivalents and short-term investments as of March 31,

2026, were $25.0 million, as compared to $30.8 million as of December 31, 2025. 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-109 in healthy volunteers and TTI-101 in 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 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 Annual Report on Form 10-K for the year ended December 31, 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 March 31,

As of

December 31,

2026

2025

Assets

Current assets:

Cash and cash equivalents

$ 19,851

$ 20,734

Short-term investments

5,130

10,077

Prepaid expenses and other current assets

345

727

Total current assets

25,326

31,538

Property and equipment, net

Intangible assets, net

306

322

Operating lease right-of-use assets

124

144

Other non-current assets

Total assets

$ 25,817

$ 32,073

Liabilities and Stockholders' Equity

Current liabilities:

Accounts payable

$ 4,620

$ 3,219

Accrued expenses

6,518

7,707

Operating lease liabilities, current portion

120

116

Total current liabilities

11,258

11,042

Operating lease liabilities, net of current portion

Total liabilities

11,312

11,127

Commitments and contingencies (Note 12)

Stockholders' Equity:

Common stock, $0.001 par value; 150,000,000 shares

authorized as of March 31,2026 and December 31,2025; 9,381,344 shares issued and outstanding as of March 31,2026 and

December 31,2025

Additional paid-in capital

131,749

131,379

Accumulated other comprehensive income

Accumulated deficit

(117,254 )

(110,450 )

Total stockholders' equity

14,505

20,946

Total liabilities and stockholders' equity

$ 25,817

$ 32,073

TVARDI THERAPEUTICS

Consolidated Statement

of Operations

(unaudited)

For the Three Months Ended

March 31,

2026

2025

Operating expenses:

Research and development

$ 4,911

$ 3,111

General and administrative

2,140

1,243

Total operating expenses

7,051

4,354

Loss from operations

(7,051 )

(4,354 )

Interest income

247

275

Other expense

—

(5,500 )

Net loss

$ (6,804 )

$ (9,579 )

Net loss per share attributable to common stockholders, basic and diluted

$ (0.73 )

$ (3.72 )

Weighted-average common shares outstanding, basic and diluted

9,381,344

2,575,462

Comprehensive loss:

Net loss

$ (6,804 )

$ (9,579 )

Unrealized (loss) gain on short-term investments

(7 )

Comprehensive loss

$ (6,811 )

$ (9,577 )

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