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
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.
“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,”
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
General and administrative expenses were
Net loss for the three months ended
Basic and diluted net loss per share attributable to common shareholders for the three months ended
Cash, cash equivalents and short-term investments as of
About
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
Contacts:
For Tvardi:
Tvardi Investor Relations
ir@tvardi.com
PJ Kelleher
617-430-7579
pkelleher@lifesciadvisors.com
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 | ||||
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 | ) | |
Source: Tvardi Therapeutics