Company: TVRD
Filing Date: 2025-02-14
Form Type: 424B3
Source: 0001104659-25-014310
Chunk: 477

Company: Tvardi Therapeutics, Inc.
Filing Date: 2025-02-14
Form: 424B3
Chunk 477
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 OF CONTENTS

| Fibrosis- 
 driven    
 Disease   | ​ | ​ | Mouse Models                                    | ​ | ​ | Observations of TTI-101 Administration                                                                                                        | ​ |
| ​         | ​ | ​ | Humanized mice + patient derived HCC xenografts | ​ | ​ | •                                                                                                                                             
 Reduced tumor size with monotherapy, as measured by tumor weight                                                                              
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 Observed additive effect in reducing tumor size, as measured by tumor weight, with TTI-101 in combination with HCC standard of care therapies 
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GEM: genetically engineered mouse Observed Reduction of Fibrotic Lung Tissue and Improved Lung Function with TTI-101 in a Bleomycin-Induced IPF Mouse Model Dr. Tweardy and his collaborators at BCM demonstrated that administration of TTI-101 resulted in downregulation of targets associated with fibrosis, attenuation of fibrosis and recovery of lung function as measured by arterial oxygen saturation levels (SO 2 ). In this preclinical study, TTI-101 was dosed 14 days after induction of fibrosis with BLM. Wild-type mice exposed to BLM displayed characteristic increases in ECM deposition and subsequent administration of TTI-101 significantly decreased all established fibrotic endpoints assessed in the model, including COL1A1, α-smooth muscle actin (α-SMA), hypoxia-inducible factor-1α (HIF-1α), and plasminogen activator inhibitor-1 (PAI-1) (p≤0.05). Administration of TTI-101 in mice also resulted in statistically significant increases in SO 2 levels (p≤0.05), which returned to near normal levels, as compared to vehicle, where SO 2 levels continued to decline in untreated mice. p = “p-value,” the conventional method for determining the statistical significance of a result, which represents the probability that random chance caused the result (e.g., a p-value = 0.01 means that there is a 1% probability that the difference between the control group and the treatment group is purely due to random chance). Generally, a p-value less than 0.05 is considered statistically significant. Reduction of Lung Fibrosis and Statistically Significant Improvement of Oxygen Saturation Observed with TTI-101 TTI-101 Targeted Multiple Pathogenic Steps of IPF in a BLM-Induced IPF Mouse Model Tvardi conducted a dose