Tvardi Therapeutics Announces Third Quarter 2026 Results and Provides Business Update

Rhea-AI Summary

Tvardi Therapeutics (TVRD) reported a third-quarter 2026 net loss of $6.124 million while advancing plans for its clinical programs. The loss widened from $5.527 million a year earlier, while basic and diluted loss per share narrowed to $0.48 from $0.59. Research and development expenses rose to $4.474 million; general and administrative expenses fell to $1.854 million.

Cash and cash equivalents totaled $22.275 million at September 30, versus $30.811 million in cash, cash equivalents and short-term investments at year-end 2025. Tvardi expects existing cash to fund planned operations into the third quarter of 2027. It plans to initiate a TTI-109 ulcerative colitis trial in 2027, subject to clearance of its Investigational New Drug application and additional funding. The company expects topline results from its Phase 1b/2 TTI-101 liver cancer study early in the first quarter of 2027.

10 points · 0 major

MixediHow this balance works

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 12 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.TTI-109 ulcerative colitis trial initiation is planned for 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.TTI-101 Phase 1b/2 liver cancer topline data are expected early in the first quarter of 2027.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Existing cash is expected to fund currently planned operations into the third quarter of 2027.
• Moderate pointThird-quarter general and administrative expenses fell to $1.854 million from $2.335 million a year earlier.
• Minor pointTTI-109 Phase 1 healthy-volunteer results showed TTI-101-equivalent exposure with improved tolerability and evidence of target engagement.

5 minor points

• Minor pointTTI-101 preclinical chronic-colitis findings included approximately eightfold higher colon tissue exposure than plasma and prevention of colon adenocarcinomas.
• Minor pointThird-quarter basic and diluted loss per share narrowed to $0.48 from $0.59 a year earlier.
• Minor pointNine-month general and administrative expenses fell to $6.621 million from $6.641 million a year earlier.
• Minor pointTotal liabilities fell to $8.077 million at September 30, 2026, from $11.127 million at year-end 2025.
• Minor pointNine-month diluted loss per share narrowed to $1.85 from $2.50 a year earlier.

Negative

• Moderate pointTTI-109 advancement into ulcerative colitis requires additional funding and Investigational New Drug application clearance.
• Moderate pointThird-quarter net loss widened to $6.124 million from $5.527 million a year earlier.
• Moderate pointCash and cash equivalents were $22.275 million, versus $30.811 million including short-term investments at year-end 2025.
• Moderate pointCommon shares outstanding increased to 13,345,956 at September 30, 2026, from 9,381,344 at year-end 2025.
• Moderate pointThird-quarter research and development expenses rose to $4.474 million from $3.603 million a year earlier.
• Moderate pointStockholders' equity fell to $15.456 million at September 30, 2026, from $20.946 million at year-end 2025.

6 minor points

• Minor pointNine-month net loss widened to $19.385 million from $10.939 million a year earlier.
• Minor pointNine-month research and development expenses rose to $13.387 million from $12.520 million a year earlier.
• Minor pointThird-quarter interest income fell to $204,000 from $411,000 a year earlier.
• Minor pointNine-month interest income fell to $623,000 from $1.063 million a year earlier.
• Minor pointNine-month other income was zero, compared with $7.159 million a year earlier.
• Minor pointNine-month basic loss per share widened to $1.85 from $1.62 a year earlier.

News Explained

Tvardi Therapeutics reported 13,345,956 common shares issued and outstanding at September 30, 2026, up from 9,381,344 at December 31, 2025; for holders whose share counts did not rise alongside the total, this expands the ownership denominator and reduces their percentage stake.

Key Figures

Colon tissue exposure: approximately eightfold higher than plasma Research and development expenses: $4.5 million vs. $3.6 million General and administrative expenses: $1.9 million vs. $2.3 million +5 more

Colon tissue exposure

approximately eightfold higher than plasma

TTI-101 in a preclinical chronic colitis model

Research and development expenses

$4.5 million vs. $3.6 million

Three months ended September 30, 2026 vs. 2025

General and administrative expenses

$1.9 million vs. $2.3 million

Three months ended September 30, 2026 vs. 2025

Net loss

$6.1 million vs. $5.5 million

Three months ended September 30, 2026 vs. 2025

Net loss per share

$(0.48) vs. $(0.59)

Three months ended September 30, 2026 vs. 2025

Cash and cash equivalents

$22.3 million

As of September 30, 2026

Expected cash runway

Into the third quarter of 2027

Operations, as currently planned

HCC topline data

Early first quarter of 2027

TTI-101 Phase 1b/2 REVERT LIVER CANCER study

Previous Earnings Reports

2 past events · Latest: Aug 14

Same Type 2 events

1. Aug 14

   Q2 earnings

   24h Move

   +7.3%

   TTI-109 Phase 1 results supported UC development plans, pending IND clearance and funding.

2. May 08

   Q1 earnings

   24h Move

   -0.7%

   TTI-101 HCC topline results were expected in 2H 2026; this update moves the target to early Q1 2027.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug (ind), pharmacodynamic, prodrug, hepatocellular carcinoma, +1 more

5 terms

investigational new drug (ind) regulatory

"subject to clearance of our Investigational New Drug (IND) application"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

pharmacodynamic medical

"providing pharmacodynamic evidence of STAT3 target engagement"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

prodrug medical

"The Phase 1 results confirmed the prodrug design"

A prodrug is an inactive or less-active compound that is designed to be converted into an active drug inside the body, like a packaged meal that needs heating before it's ready to eat. For investors, prodrugs matter because this design can improve how a medicine is absorbed, reduce side effects, extend patent protection, or enable new dosing forms — all factors that can affect a drug's regulatory path, marketability, and commercial value.

hepatocellular carcinoma medical

"TTI-101 in hepatocellular carcinoma (NCT05440708)"

Hepatocellular carcinoma is the most common form of primary liver cancer, arising from the main functional cells of the liver. For investors it matters because its serious health impact drives demand for diagnostic tests, treatments and long-term care; progress in trials or approvals can change a drugmaker’s revenue outlook much like a successful product launch can reshape a company’s future.

adenocarcinomas medical

"prevented the formation of colon adenocarcinomas"

Adenocarcinomas are cancers that start in gland-like cells that line organs and produce fluids or mucus, such as in the lung, colon, pancreas, breast or prostate. They matter to investors because they define large, specific patient groups for drug development, clinical trials and medical devices—akin to identifying a market niche—and influence potential sales, regulatory risk and healthcare spending tied to treatments and diagnostics.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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HOUSTON, Nov. 13, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi” or the “Company”) (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 third quarter ended September 30, 2026, and provided a business update.

Business and Clinical Program Updates:

TTI-109 – Ulcerative Colitis (UC)

• Advancing development plans for TTI-109 in UC. Building on positive Phase 1 healthy volunteer results reported in July and the subsequent selection of UC as its initial target indication, Tvardi is preparing to advance TTI-109 into clinical development in UC, subject to clearance of our Investigational New Drug (IND) application and additional funding.
  • The Phase 1 results confirmed the prodrug design, with TTI-109 delivering TTI-101-equivalent exposure with improved tolerability and, across the active dose range, demonstrated reductions in cellular and humoral immune populations known to correlate with UC disease severity, providing pharmacodynamic evidence of STAT3 target engagement.
• Published additional preclinical data supporting STAT3 inhibition in UC. New findings published in the International Journal of Molecular Sciences demonstrated that, in a preclinical model of chronic colitis, TTI-101 achieved colon tissue exposure approximately eightfold higher than in plasma, normalized disease-associated changes in colon gene expression, muted colitis-associated changes in the gut microbiome and prevented the formation of colon adenocarcinomas, a long-term consequence of chronic colitis.
  • The preclinical data highlights the potential of STAT3 inhibition to address immune dysregulation, inflammation and fibrosis that drive UC progression. These findings build on prior preclinical studies in which TTI-101 and TTI-109 significantly reduced disease activity across three acute colitis models representing distinct immune axes.
    
    

TTI-101 – Hepatocellular Carcinoma (HCC)

• Advancing Phase 1b/2 REVERT LIVER CANCER study toward topline readout in early first quarter of 2027. The ongoing REVERT LIVER CANCER study is evaluating TTI-101 as monotherapy and in combination with established therapies in patients with HCC. The Company expects to report topline data early in the first quarter of 2027 to allow for complete cohort evaluation.
  
  

Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “We continue to make meaningful progress across our pipeline. Positive Phase 1 results for TTI-109 have strengthened our confidence in its potential as we prepare to advance this next-generation STAT3 inhibitor into clinical development in ulcerative colitis and potentially other inflammatory bowel diseases in 2027, subject to the availability of additional funding. In HCC, we remain encouraged by the previously reported interim results for TTI-101 and look forward to the topline readout in early first quarter of 2027, which will help inform our next steps.”

Key Upcoming Milestones

• 2027: Initiation of clinical trial of TTI-109 in UC, subject to IND clearance and additional funding
• Early first quarter of 2027: TTI-101 Phase 1b/2 HCC topline data
  
  

Third Quarter 2026 Financial Results

Research and development expenses for the three months ended September 30, 2026, were $4.5 million, compared to $3.6 million for the comparable period in 2025. The increase was primarily driven by higher clinical costs associated with TTI-101.

General and administrative expenses were $1.9 million for the three months ended September 30, 2026, compared to $2.3 million for the three months ended September 30, 2025. The decrease was primarily driven by lower professional fees.

Net loss for the three months ended September 30, 2026, was $6.1 million, compared to a net loss of $5.5 million for the three months ended September 30, 2025.

Basic and diluted net loss per share attributable to common stockholders for the three months ended September 30, 2026, were both $(0.48), compared to basic and diluted net loss per share of $(0.59) for the three months ended September 30, 2025.

Cash and cash equivalents as of September 30, 2026, were $22.3 million, compared to cash, cash equivalents and short-term investments of $30.8 million as of December 31, 2025. Tvardi anticipates that its existing cash and cash equivalents will be sufficient to fund operations, as currently planned, into the third quarter of 2027. Advancing TTI-109 into UC and additional indications remain subject to additional funding and IND clearance.

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 immune dysregulation, inflammation, and proliferation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The Company has completed a Phase 1 healthy volunteer study of TTI-109 and plans to initiate clinical trials of TTI-109 in ulcerative colitis pending IND clearance and the availability of additional funding. The Company is also conducting a Phase 1b/2 clinical trial of 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 or safety or other complications related to its product candidates; the ability to obtain IND clearance for TTI-109 in UC on the timelines expected or at all; the ability to replicate results for preclinical studies and early clinical trials in later trials; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; 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 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; 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, amounts in thousands, except share and per share amounts)
		As of September 30,				As of December 31,
		2026				2025
Assets
Current assets:
Cash and cash equivalents		$	22,275			$	20,734
Short-term investments			—				10,077
Prepaid expenses and other current assets			855				727
Total current assets			23,130				31,538
Property and equipment, net			28				52
Intangible assets, net			275				322
Operating lease right-of-use assets			83				144
Other non-current assets			17				17
Total assets		$	23,533			$	32,073
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	2,076			$	3,219
Accrued expenses			5,885				7,707
Operating lease liabilities, current portion			116				116
Total current liabilities			8,077				11,042
Operating lease liabilities, net of current portion			—				85
Total liabilities			8,077				11,127
Stockholders' Equity:
Common stock, $0.001 par value; 150,000,000 shares authorized as of September 30, 2026 and December 31, 2025; 13,345,956 shares and 9,381,344 shares issued and outstanding as of September 30, 2026 and December 31, 2025, respectively			13				9
Additional paid-in capital			145,278				131,379
Accumulated other comprehensive income			—				8
Accumulated deficit			(129,835	)			(110,450	)
Total stockholders' equity			15,456				20,946
Total liabilities and stockholders' equity		$	23,533			$	32,073

TVARDI THERAPEUTICS Consolidated Statements of Operations (Unaudited, amounts in thousands, except share and per share amounts)
		For the Three Months Ended September 30,								For the Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development		$	4,474			$	3,603			$	13,387			$	12,520
General and administrative			1,854				2,335				6,621				6,641
Total operating expenses			6,328				5,938				20,008				19,161
Loss from operations			(6,328	)			(5,938	)			(20,008	)			(19,161	)
Interest income			204				411				623				1,063
Other income, net			—				—				—				7,159
Net loss		$	(6,124	)		$	(5,527	)		$	(19,385	)		$	(10,939	)
Net loss per share attributable to common stockholders:
Basic		$	(0.48	)		$	(0.59	)		$	(1.85	)		$	(1.62	)
Diluted		$	(0.48	)		$	(0.59	)		$	(1.85	)		$	(2.50	)
Weighted-average common shares outstanding:
Basic			12,653,836				9,377,079				10,484,162				6,757,955
Diluted			12,653,836				9,377,079				10,484,162				7,244,785
Comprehensive loss:
Net loss		$	(6,124	)		$	(5,527	)		$	(19,385	)		$	(10,939	)
Unrealized (loss) gain on short-term investments			—				20				(8	)			7
Comprehensive loss		$	(6,124	)		$	(5,507	)		$	(19,393	)		$	(10,932	)

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much did Tvardi lose in the third quarter of 2026?

Tvardi recorded a $6.124 million net loss for the three months ended September 30, 2026, compared with $5.527 million a year earlier. Basic and diluted loss per share were both $0.48, compared with $0.59 a year earlier.

When does Tvardi expect its next clinical milestones?

Tvardi expects TTI-101 Phase 1b/2 liver cancer topline data early in the first quarter of 2027 and plans to initiate a TTI-109 ulcerative colitis trial in 2027. The ulcerative colitis trial remains subject to Investigational New Drug application clearance and additional funding.

What did Tvardi's TTI-109 Phase 1 study show?

The healthy-volunteer study showed TTI-101-equivalent exposure with improved tolerability. Across the active dose range, it also demonstrated reductions in cellular and humoral immune populations known to correlate with ulcerative colitis disease severity, providing evidence that the treatment engaged its STAT3 target.

Why did Tvardi's third-quarter research and administrative expenses change?

Higher clinical costs associated with TTI-101 primarily drove the increase in research and development expenses, while lower professional fees primarily drove the decrease in general and administrative expenses.