New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$25m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$25m free cash flow). Share price has been highly volatile over the past 3 months (49% average weekly change). Earnings are forecast to decline by an average of 21% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$57m net loss in 3 years). Market cap is less than US$100m (€15.4m market cap, or US$17.8m). Annonce • Jul 31
Tvardi Therapeutics Selects Ulcerative Colitis as Initial Indication for TTI-109 Tvardi Therapeutics, Inc. has selected ulcerative colitis (UC) as the initial disease indication for its next generation STAT3 inhibitor, TTI-109. Tvardi’s decision follows its successful Phase 1 healthy volunteer study, in which TTI-109 successfully modulated multiple STAT3-driven immune cell populations, including Th17, T follicular helper (Tfh) and B cells. These same cell types are known to expand with UC disease severity and infiltrate the inflamed colon. Further analysis of immune cell populations across the active dose range elucidated: Broad suppression of pathogenic Th17-associated immune populations, including up to 76% reduction in subsets associated with mucosal destruction and treatment-refractory UC. The Tfh immune populations that drive mucosal B cell responses were reduced up to 43% in Tfh subsets associated with disease UC activity. Suppression extended to B cell (humoral) immunity, including up to 71% decline in subsets associated with colonic inflammation. STAT3 sits at the center of the three interconnected processes that drive UC: immune dysregulation, chronic inflammation and the tissue remodeling that leads to fibrosis, positioning it as a single, convergent therapeutic target for a disease with multiple underlying drivers. These findings are further supported by published clinical studies linking reductions in activated STAT3 with higher rates of clinical remission across multiple UC therapeutic classes. UC is a large and underserved market. More than 1,250,000 patients are diagnosed with UC in the United States, representing an addressable market of approximately $3 billion in the U.S. and $9 billion globally. Currently approved therapies, including anti-TNF, anti-integrin, anti-IL-12/23, S1P and JAK inhibitors, achieve placebo-adjusted clinical remission rates below 30%, and most are administered parenterally. Additionally, JAK inhibitors carry a black box warning for major adverse cardiovascular events, mortality, thrombosis, serious infections and malignancy. By contrast, TTI-109, an oral small molecule, is designed to inhibit STAT3 directly, addressing the inflammation, immune dysregulation and proliferation that single-pathway therapies leave unresolved. Across more than 400 subjects dosed to date with Tvardi’s STAT3 inhibitors demonstrated a differentiated safety profile from JAK inhibitors. TTI-109 is administered orally without a loading dose, and in preclinical models of UC, achieved more than eight-fold greater drug concentration in target tissue relative to plasma. Tvardi plans to initiate a study of TTI-109 in patients with moderate-to-severe UC in 2027, subject to clearance of Investigational New Drug (IND) application and additional funding. The primary endpoint will be safety, and the secondary endpoint will be clinical remission at 12 weeks. Exploratory pharmacodynamic endpoints will include serum/tissue biomarkers and analysis of single nucleotide polymorphisms (SNPs). Annonce • Jul 07
Tvardi Therapeutics Announces Phase 1 Results For TTI-109 And Plans Advancement Into Dermatologic And Gastrointestinal Diseases Tvardi Therapeutics announced Phase 1 results for TTI-109, its next-generation STAT3 inhibitor. TTI-109 is a phosphate prodrug of TTI-101 designed to improve delivery and tolerability while preserving the parent compound's mechanism of action. The study confirmed rapid prodrug conversion, dose-proportional pharmacokinetics with exposures above the STAT3 IC50 and, in an exploratory pharmacodynamic analysis, reductions of up to 60% in STAT3-driven immune cell populations across Th17, Tfh and B cell subsets. Key findings include: Confirmed prodrug conversion and exposure equivalence: Validating its prodrug design, TTI-109 rapidly converted to TTI-101 within two hours and produced nearly identical plasma levels at molar-equivalent doses. Sustained target-level exposure: 21-day repeat dosing showed stable, dose-proportional pharmacokinetics, with TTI-101 concentrations above the STAT3 IC50. Evidence of target engagement: Pharmacodynamic data showed reductions of up to 60% across disease-relevant STAT3-driven immune cell populations including Th17 cells, Tfh and B cell subsets. Improved tolerability vs. TTI-101: Compared with placebo, diarrhea events with TTI-109 were similar in duration, transient, and resolved without treatment interruption. Compared with TTI-101 at near-equivalent doses, diarrhea events with TTI-109 were substantially shorter in duration (0.46 vs. 3.35 days). The study was conducted in three parts. Part A was a randomized, double-blind, placebo-controlled single ascending dose study of TTI-109 at four doses (n=8/cohort). Part B was a bioequivalence crossover comparing TTI-101 and TTI-109 in both sequences with a 48-hour washout (n=6/sequence). Part C was a randomized, double-blind, placebo-controlled multiple ascending dose study with 21 days of twice-daily dosing at four doses, plus a TTI-101 reference arm (n=8/cohort). Primary objectives were to confirm rapid conversion of TTI-109 to TTI-101, demonstrate equivalent exposures at molar-equivalent doses, demonstrate dose-dependent increases in TTI-101 exposure and characterize safety and tolerability versus TTI-101 and placebo. Pharmacodynamic effects were an exploratory objective. The Company has identified dermatologic and gastrointestinal therapeutic areas with shared STAT3-driven disease biology, specifically the convergence of cytokines, growth factors and Th17 and B cell immune pathways at the STAT3 node. TTI-109 is designed to address both the cellular and humoral components of inflammation and proliferation with a single oral agent. Recent programs in related STAT3-driven indications have validated the underlying biology, but each acts on a single upstream target, while TTI-109 targets STAT3, the downstream node where these pathways converge. STAT3 sits at the center of the core disease processes in dermatologic and gastrointestinal diseases, including inflammation, proliferation and cellular and humoral dysregulation. Tvardi's STAT3 inhibitors have demonstrated biologic activity in these pathways in both preclinical models and in the clinic. In preclinical disease models, the Company’s STAT3 inhibitors reduced inflammatory cascades, fibrosis and modulated immune activity. Similarly, in humans, TTI-101 reduced activated STAT3 levels, inflammatory cascades and fibrosis. The TTI-109 healthy volunteer study extended this translational profile, with reductions in STAT3-driven immune cell populations. Tvardi's ability to initiate these programs is subject to clearance of an Investigational New Drug application (IND) and the availability of additional funding. Annonce • May 03
Tvardi Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $12.5 million. Tvardi Therapeutics, Inc. has filed a Follow-on Equity Offering in the amount of $12.5 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Annonce • Mar 09
Tvardi Therapeutics, Inc., Annual General Meeting, Jun 09, 2026 Tvardi Therapeutics, Inc., Annual General Meeting, Jun 09, 2026. Annonce • Jan 08
Tvardi Therapeutics Announces Further Phase 2 REVERT IPF Data, Expanding Clinical Insights Tvardi Therapeutics, Inc. provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF), with preliminary results previously announced on October 13, 2025. Additional analysis was conducted to assess the impact of STAT3 inhibition using TTI-101 on fibrosis, inflammatory markers and pulmonary function, and this analysis was limited to patients who were exposed to the study drug for 12 weeks. Following review of pharmacokinetics and adverse events, one patient was removed from the analysis due to receiving less than 60% of the expected dosing, two patients were removed due to no measurable TTI-101 observed in the blood and no reported adverse events, and one additional patient was removed as an outlier because pulmonary function initially improved on treatment but was later severely impacted by acute bronchitis deemed unrelated to the study drug. This resulted in a dataset of 40 patients analyzed, including 16 pooled patients treated with TTI-101 and 24 patients treated with placebo. Data highlights showed that fibrosis decline was greater in patients treated with TTI-101 compared to placebo, at -9.4% versus -2.4%, respectively, based on baseline-weighted high resolution CT lung fibrosis scores that were centrally read, blinded and independently assessed. In terms of inflammation, a greater decline in IL-6 was observed among TTI-101-treated patients compared to placebo, with an even greater reduction seen in patients with higher baseline IL-6 levels; IL-6 is a key pro-inflammatory cytokine that signals through STAT3, and inhibition of STAT3 is expected to reduce downstream inflammatory signaling associated with disease. Additionally, 63% of pooled patients treated with TTI-101 demonstrated an increase in forced vital capacity (FVC) at 12 weeks compared to 46% of patients in the placebo group, and the mean FVC change in TTI-101-treated patients was -15 mL, representing a smaller decline than observed in the REVERT placebo group (-22 mL) and historical placebo groups from comparable IPF trials. The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled study of TTI-101 alone or in combination with nintedanib (OFEV®) in patients with IPF, designed to assess safety, pharmacokinetics and exploratory outcomes related to lung function, and Tvardi announced on October 13, 2025 that the study did not meet its goals after reviewing preliminary safety data and efficacy results. 
