Tvardi Therapeutics Announces First Quarter 2026 Results and Provides Business Update

Rhea-AI Summary

Tvardi Therapeutics (NASDAQ: TVRD) reported Q1 2026 results and a business update. Key near-term catalysts include TTI-109 healthy volunteer topline data expected in June 2026 and a planned clinical development strategy, and TTI-101 Phase 1b/2 HCC topline results expected in 2H 2026.

Q1 figures: R&D $4.9M, G&A $2.1M, net loss $6.8M (loss per share $(0.73)), and cash/short-term investments $25.0M, with management stating runway into Q4 2026.

Positive

• TTI-109 healthy volunteer topline data expected in June 2026
• TTI-101 HCC Phase 1b/2 topline results on track for 2H 2026
• TTI-101 IPF showed 9.4% fibrosis reduction versus 2.4% placebo
• TTI-101 treatment linked to a 4.5-fold greater IL-6 decline
• Cash, cash equivalents and short-term investments of $25.0M
• Company expects cash runway through clinical readouts into Q4 2026

Negative

• Net loss of $6.8M for Q1 2026
• Basic and diluted net loss per share of $(0.73)
• Cash balance declined from $30.8M (Dec 31, 2025) to $25.0M
• R&D expenses increased to $4.9M year-over-year
• G&A expenses increased to $2.1M year-over-year

News Market Reaction – TVRD

-0.71%

-0.71% Session close to close

In the May 8 session, TVRD declined 0.71%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reiterates Tvardi’s strategy around its STAT3 portfolio, with Phase 1 healthy volu...

Analysis

This announcement reiterates Tvardi’s strategy around its STAT3 portfolio, with Phase 1 healthy volunteer topline data for TTI-109 targeted for June 2026 and Phase 1b/2 TTI-101 HCC data in 2H 2026. Q1 2026 results show higher R&D and G&A but a narrower $6.8M net loss and cash of $25.0M, supporting a runway into Q4 2026. Investors may watch progress toward these readouts, usage of the new $200,000,000 shelf, and any updates on IPF and HCC data quality.

Key Figures

R&D expenses: $4.9M G&A expenses: $2.1M Net loss: $6.8M +5 more

8 metrics

R&D expenses $4.9M Three months ended March 31, 2026 (vs $3.1M in Q1 2025)

G&A expenses $2.1M Three months ended March 31, 2026 (vs $1.2M in Q1 2025)

Net loss $6.8M Q1 2026 net loss (vs $9.6M in Q1 2025)

Net loss per share $(0.73) Basic and diluted Q1 2026 (vs $(3.72) in Q1 2025)

Cash & equivalents $25.0M As of March 31, 2026 (vs $30.8M as of Dec 31, 2025)

Fibrosis score change 9.4% vs 2.4% Baseline-weighted reduction with TTI-101 vs placebo in Phase 2 IPF

IL-6 decline 4.5-fold greater TTI-101 vs placebo, central STAT3-driven inflammatory cytokine

Cash runway Into Q4 2026 Company guidance based on current operating plan

Previous Earnings Reports

3 past events · Latest: Nov 13 (Neutral)

Same Type Pattern 3 events

Date	Event	Sentiment	24h Move	Catalyst
Nov 13	Quarterly earnings update	Neutral	-1.9%	Q3 2025 results, runway into Q4 2026, mixed IPF Phase 2 outcome.
Aug 14	Quarterly earnings update	Positive	+0.9%	Q2 2025 results with $41.0M cash, net income from $12.8M note gain.
May 13	Quarterly earnings update	Positive	-0.7%	Q1 2025 results, Cara merger cash of $23.8M and $28.3M placement.

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

Pattern Detected

Earnings and business updates have historically produced modest moves (average about -0.6%), with shares often reacting only slightly despite clinical and cash runway updates.

Recent Company History

Across past earnings updates in Q1, Q2, and Q3 2025, Tvardi repeatedly highlighted cash runway into Q4 2026 and milestones for TTI-101 and TTI-109. Results mixed positive financial items (like Q2 2025 net income helped by a $12.8M remeasurement gain) with clinical uncertainties, including the REVERT IPF trial not meeting goals. Price reactions stayed contained at roughly +/-1–2%. Today’s Q1 2026 update again reiterates runway into late 2026 and similar clinical timelines, but the pre-news setup shows a much stronger upside move than prior earnings days.

Key Terms

stat3, hepatocellular carcinoma, fibrosis, il-6, +4 more

8 terms

stat3 medical

"targeting STAT3 to treat inflammatory and proliferative diseases, today reported"

STAT3 is a protein inside cells that acts like a control knob for turning sets of genes on or off, influencing cell growth, survival and immune responses. For investors, STAT3 matters because drugs or tests that block or measure its activity can be used to treat or track cancers and inflammatory diseases, so progress on STAT3-targeted therapies or diagnostics can affect the value and prospects of biotech and pharmaceutical firms.

hepatocellular carcinoma medical

"Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) on track for 2H 2026"

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.

fibrosis medical

"was associated with a 9.4% baseline-weighted reduction in fibrosis score compared"

Fibrosis is the process where excess scar tissue forms in an organ or tissue, often as a response to injury or long-term damage. This buildup can impair normal function, much like thickening insulation reduces the effectiveness of a wire. For investors, fibrosis is significant because it can signal ongoing health issues that may lead to increased medical costs or influence a company’s performance in healthcare-related sectors.

il-6 medical

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

Interleukin-6 (IL-6) is a small signaling protein the body releases as an alarm during infection, injury, or chronic inflammation; think of it as a smoke detector that calls immune cells to action. It matters to investors because IL-6 levels can serve as a biomarker for disease severity and a target for therapies—drugs that block or modulate IL-6 can change treatment outcomes, regulatory decisions, and commercial prospects in healthcare markets.

prodrug medical

"offering improved tolerability through its prodrug profile and enabling broader"

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.

phase 2 medical

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

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 1b/2 medical

"TTI-101 (HCC – REVERT LIVER CANCER study): Phase 1b/2 trial remains on track"

Phase 1b/2 is a combined early-stage human study that first checks a drug’s safety and side effects in a small group and then expands to test whether it shows signs of working in patients. Think of it as a product test that first confirms it’s safe to use, then looks for early evidence of benefit; positive results can significantly reduce clinical risk and increase a company’s value, while negative results raise the opposite.

shelf registration regulatory

"Shelf Registration Statement"

Shelf registration is when a company gets permission ahead of time to sell new stocks or bonds over a period of time instead of all at once. It matters to investors because it lets a company raise money quickly when needed, but it can also change the value of existing shares if many new ones are sold.

View in glossary

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

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, May 08, 2026 (GLOBE NEWSWIRE) -- 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			44				52
Intangible assets, net			306				322
Operating lease right-of-use assets			124				144
Other non-current assets			17				17
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			54				85
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			9				9
Additional paid-in capital			131,749				131,379
Accumulated other comprehensive income			1				8
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	)			2
Comprehensive loss		$	(6,811	)		$	(9,577		)

FAQ

When will Tvardi (TVRD) report topline data for TTI-109?

Topline results for TTI-109 are expected in June 2026. According to the company, the data come from a healthy volunteer study and will inform the clinical development strategy for the next-generation STAT3 inhibitor.

What is the timing for Tvardi (TVRD) TTI-101 Phase 1b/2 HCC results?

TTI-101 Phase 1b/2 HCC topline results are on track for the second half of 2026. According to the company, prior interim findings showed clinically meaningful activity across treatment settings pending full dataset review.

What did Tvardi report about TTI-101 results in IPF?

In the Phase 2 IPF analysis, TTI-101 showed a 9.4% baseline-weighted fibrosis reduction versus 2.4% for placebo. According to the company, treatment also produced a 4.5-fold larger decline in IL-6, a STAT3-driven cytokine.

How much cash does Tvardi (TVRD) have and how long will it fund operations?

Tvardi reported $25.0 million in cash, cash equivalents and short-term investments as of March 31, 2026. According to the company, this is expected to fund operations through clinical readouts and into Q4 2026 under current plans.

What were Tvardi's key Q1 2026 financial results affecting investors?

For Q1 2026, R&D expenses were $4.9M, G&A $2.1M, and net loss $6.8M (loss per share $(0.73)). According to the company, R&D increased primarily due to TTI-109 development costs.