Tvardi Therapeutics Announces Fourth Quarter and Full-Year 2025 Results and Provides Business Update
Rhea-AI Summary
Tvardi Therapeutics (NASDAQ: TVRD) reported fourth-quarter and full-year 2025 results and provided a clinical update. Cash, cash equivalents and short-term investments were $30.8M as of Dec 31, 2025, with a runway expected into Q4 2026. Net loss for 2025 was $18.2M versus $29.4M in 2024.
Clinical milestones: topline healthy volunteer data for next-generation STAT3 inhibitor TTI-109 expected in Q2 2026; topline Phase 1b/2 REVERT LIVER CANCER results for TTI-101 anticipated in H2 2026. REVERT IPF analysis showed a 9.4% fibrosis reduction vs 2.4% for placebo.
Positive
- Cash $30.8M expected to fund operations into Q4 2026
- Full-year net loss $18.2M, improved vs $29.4M in 2024
- R&D down to $18.0M in 2025 from $23.7M in 2024
- Topline TTI-109 healthy volunteer data expected Q2 2026
- Topline TTI-101 REVERT LIVER CANCER data anticipated H2 2026
Negative
- G&A increased to $8.7M in 2025 from $4.5M in 2024
- Cash balance modest at $30.8M, limiting runway beyond Q4 2026 absent financing
News Market Reaction – TVRD
In the Apr 1 session, TVRD declined 5.66%, reflecting a notable negative market reaction. Argus tracked a trough of -6.8% from its starting point during tracking. Our momentum scanner triggered 13 alerts that day, indicating notable trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 12 | Investor conferences | Neutral | -1.6% | Announcement of participation in four investor conferences across Feb–Mar 2026. |
| Jan 08 | Conference presentation | Positive | +7.6% | J.P. Morgan conference presentation featuring new encouraging Phase 2 REVERT IPF data. |
| Jan 08 | Clinical data update | Negative | +8.7% | Expanded Phase 2 REVERT IPF analyses after noting the study did not meet goals. |
| Nov 18 | Investor conference | Neutral | +2.2% | Participation and fireside chat at the Piper Sandler healthcare conference. |
| Nov 13 | Earnings and update | Negative | -1.9% | Q3 2025 results plus disclosure that Phase 2 REVERT IPF did not meet goals. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news often produced modestly positive or muted reactions, with one notable divergence where negative clinical framing coincided with a strong gain.
Over the last few months, Tvardi has alternated between clinical and investor-relations updates. In November 2025, Q3 results highlighted reduced R&D and cash of $36.5M with runway into Q4 2026, but also noted the Phase 2 REVERT IPF trial did not meet goals. Subsequent conference appearances in November 2025 and February 2026 drew modest price changes. On January 8, 2026, additional Phase 2 REVERT IPF data and a J.P. Morgan presentation, both emphasizing encouraging biomarker trends, were followed by stronger positive stock reactions.
Key Terms
stat3 medical
hepatocellular carcinoma medical
fibrosis medical
il-6 medical
phase 2 medical
phase 1b/2 medical
monotherapy medical
topline data technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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, March 31, 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 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 to2.4% 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
General and administrative expenses were
Net loss for the three months ended December 31, 2025, was
Basic and diluted net loss per share attributable to common shareholders for the three months ended December 31, 2025, were a net loss of
Cash, cash equivalents and short-term investments as of December 31, 2025, were
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 | 72 | ||||||
| Total current assets | 31,538 | 31,686 | ||||||
| Property and equipment, net | 52 | 84 | ||||||
| Intangible assets, net | 322 | 385 | ||||||
| Operating lease right-of-use assets | 144 | 216 | ||||||
| Deferred offering costs | — | 2,811 | ||||||
| Other non-current assets | 17 | 17 | ||||||
| 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 | 85 | 201 | ||||||
| Convertible Notes | — | 30,259 | ||||||
| Total liabilities | 11,127 | 40,827 | ||||||
| Commitments and contingencies (Note 13) | ||||||||
| Redeemable convertible preferred stock (Series A, B), | — | 85,503 | ||||||
| Stockholders’ Equity (Deficit): | ||||||||
| Common stock, | 9 | 2 | ||||||
| Additional paid-in capital | 131,379 | 1,103 | ||||||
| Accumulated other comprehensive income | 8 | — | ||||||
| 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 | | 1 | | - | | 8 | - | |||||||||
| Comprehensive loss | | $ | (7,274 | ) | | $ | (12,707 | ) | $ | (18,206 | ) | | $ | (29,397 | ) | |
