Core Insights - Tvardi Therapeutics Inc. reported disappointing preliminary data from the Phase 2 REVERT trial of TTI-101 for idiopathic pulmonary fibrosis (IPF), indicating that the study did not meet its goals [2][7] Data Summary - The study showed that baseline characteristics were similar across treatment arms, but the percent predicted Forced Vital Capacity (FVC) was lower in the placebo group (70.1%) compared to TTI-101 treated arms (74.1% and 81.1%) [2] - Discontinuation rates were imbalanced, with the placebo group having a lower rate (10.3%) compared to the treated arms (56.7% for 400mg and 62.1% for 800mg) [3] - The primary reason for discontinuation in the TTI-101 population was gastrointestinal adverse events, particularly among patients on concurrent nintedanib [3] - The number of efficacy evaluable patients decreased significantly by the 12-week timepoint, with placebo (n=24), 400mg (n=8), and 800mg (n=13) [4] - No statistically significant differences in exploratory efficacy were observed between placebo and treatment arms, with FVC improvement proportions being 41% for placebo, 39% for 400mg, and 44% for 800mg [5] - The placebo-treated patients' FVC decline was lower than expected compared to historical controls [6] Future Outlook - The CEO of Tvardi stated that the company did not observe a benefit of TTI-101 treatment in this study and is conducting additional analyses [7] - The company plans to report preliminary topline data in the first half of 2026 from a healthy volunteer study on TTI-109 and the Phase 2 trial of TTI-101 in hepatocellular carcinoma [7] Financial Position - As of June 30, 2025, Tvardi reported $41.0 million in cash, cash equivalents, and short-term investments, which is expected to fund operations into the fourth quarter of 2026 [8] - Tvardi Therapeutics shares were down 84.18% at $6.58, trading near its 52-week low of $15.13 [8]

Company Overview - NAYA Biosciences is developing a competitive bifunctional antibody pipeline, targeting multiple clinical milestones between 2025 and 2027[3, 6, 8] - The company utilizes a validated hub & spoke model for acquiring, developing, and partnering high-potential assets[7, 115, 125] Therapeutic Portfolio & Target Indications - The company's therapeutic portfolio includes candidates targeting hepatocellular carcinoma (HCC), multiple myeloma, prostate cancer, and autoimmune diseases[8, 10, 126] - NY-303 (GPC3 x NKp46) is being developed as a second-line monotherapy in HCC for patients not responding to first-line checkpoint inhibitors, with Phase I/IIa clinical trials planned to start in H1 2025 and data expected by H1 2026[10, 69, 79, 120] - NY-500 (PD1 x VEGF) is an AI-optimized bifunctional antibody being developed as a monotherapy for first-line HCC, with clinical data expected in 2026[10, 40, 80, 120] - NY-338 (CD38 x NKp46) is a bifunctional antibody with potential differentiation from Darzalex and T-cell engagers in multiple myeloma and autoimmune diseases[10, 91, 92, 93, 120] - NY-600 (PSMA x NKp46) is a bifunctional antibody targeting metastatic castration-resistant prostate cancer (mCRPC), with potential differentiation from T-cell engagers, antibody-drug conjugates, and radioimmunotherapeutics[10, 120] Market Opportunity & Competitive Landscape - The market for PD(L)1 antibodies is forecasted to reach $58 billion in 2025, with Keytruda generating $272 billion in sales in 2024[81] - Glypican 3 (GPC3) is expressed on 80% of HCC cells and 30-50% of other solid tumors, making it a promising target[43] - The multiple myeloma market is projected to grow from $23 billion in 2023 to $33 billion in 2030, with Darzalex sales expected to increase from $97 billion to $147 billion during the same period[91]