Tvardi Therapeutics, Inc. · NASDAQ:TVRD
Tvardi Therapeutics — Investor Presentation (January 2026)
36 slides from Tvardi Therapeutics's investor presentation, Jan 16, 2026
Slide 1: Overview January 2026
Overview January 2026
Slide 2: Forward-looking statements
This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements about our expectations regarding the potential benefits, activity, effectiveness, an
Slide 3: Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases
1. Idiopathic pulmonary fibrosis 2. Hepatocellular carcinoma 3. Investigational new drug 4. Pharmacokinetics 3 Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases Deep expertise in STAT3 biology Potential to serve as a disease-modifying therapy TTI-109: designed to enhance delivery of STAT
Slide 4: STAT3's Canonical Function Plays a Central Role in Fibrosis-Driven Diseases
STAT3’s Canonical Function Plays a Central Role in Fibrosis-Driven Diseases IL6 Growth Factor Receptors Cytokine Receptors Non-TRKs Extracellular Intrinsic: Proliferation & Survival Extrinsic: Immune Suppression Activated STAT3 is a key driver in immunosuppressive proliferative diseases Cytosol Nucl
Slide 5: STAT3's Dual Mechanism of Action in Fibrosis-Driven Diseases
5 STAT3’s Dual Mechanism of Action in Fibrosis-Driven Diseases EXTRINSICALLY Up-regulates T-cell Activation Immune Activation Regression Tvardi’s Approach Tvardi’s Impact INTRINSICALLY Down-regulates Proliferation INTRINSIC (Cellular) EXTRINSIC (Immune) Immune Suppression Pro-proliferative cells Act
Slide 6: Seasoned Leadership: Deep R&D and Operational Expertise
6 Seasoned Leadership: Deep R&D and Operational Expertise Sujal Shah Chairman Michael Wyzga Director Cynthia Smith Director Susan Shiff, PhD Director Wallace Hall Director Imran Alibhai, PhD CEO & Director Dan Conn, JD, MBA CFO John Kauh, MD CMO David Tweardy, MD Founder & Advisor Ron DePinho, MD Fo
Slide 7: Our Pipeline
1. We plan to commence clinical trials in fibrosis and/or oncology pending IND submission and FDA feedback. 7 Our Pipeline Program Indication Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestone TTI-101 Idiopathic Pulmonary Fibrosis Topline Data Reported Oct 2025 Additional Data Reported Jan 20
Slide 8: Therapeutics: TTI-101 in IPF
THERAPEUTICS TTI-101 in IPF
Slide 9: TTI-101 is Designed to Address the Unmet Need in Proliferative Disease
Well-Established Target 1. Pedroza et al. Rheum. 2017: SSc: Systemic Sclerosis; Genetically engineered model (GEM) of Tight skin (Tsk-1) mice which spontaneously develop fibrosis as a result of a duplication in the fibrillin-1 gene; 2. Kauh et al. CHEST. 2024; 3. Pedroza et al. FASEB J. 2016: IPF: I
Slide 10: REVERTIPF: Preliminary Conclusions Released October 2025
• Placebo arm overperformed compared to historical data • FVC change from baseline overlapped between treatment arms, with large variability within each cohort • Treatment emergent adverse events resulted in early discontinuations leading to a small number of patients available for efficacy analysis
Slide 11: Patient Characteristics
Kg: kilograms; SD: standard deviation; 1GI comorbidity: gastrointestinal medical history collected at baseline 11 Patient Characteristics Characteristic Placebo (n=29) TTI-101 400mg/day (n=30) TTI-101 800mg/day (n=29) Age 72.0 (9.3) 72.4 (6.9) 72.8 (7.7) Sex, Male – no. (%) 23 (79.3) 25 (83.3) 21 (7
Slide 12: Summary of Treatment-Emergent Adverse Events
Treatment-emergent adverse event: any adverse event that emerges after treatment with TTI-101 or placebo. Safety analysis performed on all patients treated with at least one dose of TTI-101. 1Occurred during safety follow-up after 12-week treatment period ended; 2No instances of drug-induced liver i
Slide 13: Treatment-Emergent Adverse Events Resulting in Discontinuations by Concomitant Nintedanib Use
Treatment emergent adverse event: any adverse event that emerges after treatment with TTI-101 or placebo. Safety analysis performed on all patients treated with at least one dose of TTI-101. 2No instances of drug-induced liver injury reported across visits or treatment groups. All increases in inves
Slide 14: Most Common Adverse Events Reported in INPULSIS vs REVERTIPF Trials
Adverse events selected to align with INPULSIS categories; safety analysis performed on all patients treated with at least one dose of TTI-101. Certain data on this slide are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are inherentl
Slide 15: Preliminary Conclusions and Additional Analyses
Post hoc Analysis Population Assessment of Individual Patient Trajectory on Study2 EES1 on Treatment at 12-weeks 15 Preliminary Conclusions and Additional Analyses 1The Efficacy Evaluable Set (EES) consists of all patients defined as all randomized patients who received at least one dose of IP and h
Slide 16: TTI-101-treated Patients Demonstrated Greater Decline in Fibrosis Score vs Placebo
Analysis performed on post hoc analysis population comparing baseline to 12 weeks. One patient missing fibrosis score; overall percent change from baseline was calculated using baseline-weighted aggregation to account for differences in initial fibrosis severity with bootstrap-based standard error (
Slide 17: TTI-101-treated Patients Demonstrated Greater IL-6 Decline vs Placebo
Analysis performed on post hoc analysis population comparing baseline to 12 weeks. 1 Three patients missing IL-6 change scores (one placebo, two TTI-101); Decline assessed using OLS: ordinary least squares regression model and standard errors 17 TTI-101-treated Patients Demonstrated Greater IL-6 Dec
Slide 18: A Greater Proportion of TTI-101-treated Patients Demonstrated Increase in FVC vs Placebo
Analysis performed on post hoc analysis population comparing baseline to 12 weeks; 1Actual mean FVC change in mL (SD) at 12 weeks. 18 A Greater Proportion of TTI-101-treated Patients Demonstrated Increase in FVC vs Placebo ↓ in FVC from baseline ↑ in FVC from baseline 63% of patients treated with TT
Slide 19: Clinical Proof of Mechanism in IPF
IPF (BLM)2,3 Clinical Proof of Mechanism Well-Established Target 1. Pedroza et al. Rheum. 2017: SSc: Systemic Sclerosis; Genetically engineered model (GEM) of Tight skin (Tsk-1) mice which spontaneously develop fibrosis as a result of a duplication in the fibrillin-1 gene; 2. Pedroza et al. FASEB J.
Slide 20: REVERTIPF Provided Additional Proof of Mechanism for STAT3 Inhibition
Certain information on this slide are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comparisons are inherently limited and may suggest misleading similarities and differences. 20 REVERTIPF Provided Additional Proof of Mechanism for STAT3 Inhibiti
Slide 21: Therapeutics: TTI-109
THERAPEUTICS TTI-109
Slide 22: TTI-109 Designed as a Prodrug to Enhance Delivery of STAT3 Inhibitor
TTI-101 TTI-109 Designed as a Prodrug to Enhance Delivery of STAT3 Inhibitor TTI-101 Phosphate prodrug designed to rapidly convert to active TTI-101 in the blood P TTI-109 • Preserve mechanism of action • Improve drug delivery • Diminish GI exposure • Patent protection TTI-109 Design 22
Slide 23: TTI-109 Possesses Desired Characteristics of Next STAT3 Inhibitor
23 TTI-109 Possesses Desired Characteristics of Next STAT3 Inhibitor IND-Enabling GLP Results ✓ No toxicology findings with TTI-109; consistent with absence of findings with TTI-101 ✓ Systemic exposures provided a large safety margin for anticipated clinical doses ✓ At equal molar doses, TTI-109 gav
Slide 24: Overall Goals for Ongoing Phase 1 Healthy Volunteer Study with TTI-109
• Confirm key findings from IND-enabling studies in a 3-part Phase 1 healthy volunteer study: Single Ascending Dose, Bio-equivalence, Multiple Ascending Dose • Pharmacokinetics • Rapid conversion of TTI-109 to TTI-101 • Dose-dependent increase in systemic exposures • TTI-109 vs TTI-101 cross-over to
Slide 25: Therapeutics: TTI-101 in HCC
THERAPEUTICS TTI-101 in HCC
Slide 26: TTI-101 Reversed Multiple Pathogenic Steps of Liver Cancer in a NASH-induced HCC Model
Jung KH et al. Clin Cancer Res. 2017. Genetically engineered HepPTEN- murine model that replicates nonalcoholic steatohepatitis (NASH) induced hepatocellular carcinoma (HCC) 26 TTI-101 Reversed Multiple Pathogenic Steps of Liver Cancer in a NASH-induced HCC Model Inflammation Fibrosis/Cirrhosis HCC
Slide 27: Phase 1 Clinical Trial: First in Human TTI-101 Monotherapy Study Design
Tsimberidou et al. Clin Cancer Res. 2025 27 Phase 1 Clinical Trial: First in Human TTI-101 Monotherapy Study Design Advanced Solid Tumors Liver Cancer Liver Cancer RP2D Other Solid Tumors Other Solid Tumors RP2D Objectives: • Primary: Maximum tolerated dose, safety, and pharmacokinetics • Secondary:
Slide 28: TTI-101 Monotherapy Led to Durable Partial Responses in Fibrotic Tumors
Tsimberidou et al. Clin Cancer Res. 2025 28 Phase 1 Clinical Trial: TTI-101 Monotherapy Led to Durable Partial Responses in Fibrotic Tumors Baseline Cycle 3, Day 1 Cycle 5, Day 1 Diameter Length in mm (% Change from Baseline) 41mm (0%) 21mm (-49%) 14mm (-66%) 46mm (0%) 19mm (-59%) 14mm (-70%) Target
Slide 29: Phase 1: TTI-101 Monotherapy Clinical Trial Summary
Tsimberidou et al. Clin Cancer Res. 2025; SD: Stable Disease; TREAE: Treatment related adverse events; F1-3: Formulation 1-3 29 Phase 1: TTI-101 Monotherapy Clinical Trial Summary PK / PD Tolerability Biological Activity • Well-tolerated BID oral dosing • No DLTs *Most severe AE counted per subject
Slide 30: Strong Rationale for TTI-101 and ICI Combination Therapy
1. Adapted from Zhao, Y et al. Hepatology. 2021 2. Cohen et al. Ann Oncol. 2018 3. Siu et al. JAMA Oncol. 2019. ICI: Immune Checkpoint Inhibition; Bev: Bevacizumab. Certain data on this slide are based on cross-study comparisons and are not based on any head-to-head clinical trials. Cross-study comp
Slide 31: TTI-101 is Designed to Provide a Distinct and Synergistic Mechanism for Unmet Need in HCC
1. World Health Organization (WHO) 2. WHO US Statistics 3. American Cancer Society 4. Represents range of ORRs from previous studies (MORPHEUS, Tempest, IMBrave150). 5. 2nd line ORR expected to be <5% as 2nd line therapies inhibit VEGF/angiogenesis as common mechanism with bevacizumab and pembrolizu
Slide 32: REVERTLiver Cancer: Phase 2 Study of TTI-101 in HCC
NCT05440708; Dayyani et al. JCO. 2024; Data as of April 2025 32 REVERTLiver Cancer: Phase 2 Study of TTI-101 in HCC • Overall Response Rate (ORR) • Duration of Response (DoR) • Progression-free survival • Liver stiffness (elastogram) • Biomarkers (IL-6/AFP) • pY-STAT3 in tumor (21 US Sites) Phase 1b
Slide 33: REVERTLiver Cancer: Interim Phase 1b/2 Data
Preliminary radiographic change from baseline RECIST measurements (best response). Data as of Aug 2024. This interim data set was not subject to the standard quality control measures typically associated with final clinical trial results. 1. Tempest press release 23 Apr 2023 of Phase 2 Study. Tempes
Slide 34: Key Takeaways: TTI-101 in HCC
34 Key Takeaways: TTI-101 in HCC Inhibition of STAT3 activation to have dual therapeutic effect on cancer cells – overcoming tumorigenesis and immune suppression Clinically meaningful activity in both monotherapy and combination therapy in areas of unmet need Topline results from ongoing Phase 2 REV
Slide 35: Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases
1. Idiopathic pulmonary fibrosis 2. Hepatocellular carcinoma 3. Investigational new drug 4. Pharmacokinetics 35 Targeting STAT3: Central Mediator of Fibrosis-Driven Diseases Deep expertise in STAT3 biology Potential to serve as a disease-modifying therapy TTI-109: designed to enhance delivery of STA
Slide 36: Financial Overview and Upcoming Milestones
1. As of November 10, 2025. 2. As of September 30, 2025 36 Financial Overview and Upcoming Milestones Select Corporate Information Ticker TVRD HQ Houston, TX Shares Outstanding1 9,381,344 Cash / Cash Equivalents / ST Investments2 $36.5 M Upcoming Milestones 1H 2026 Results from TTI-109 Phase 1 Trial
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