Core Insights - Tvardi Therapeutics is advancing its clinical pipeline with two significant milestones expected in 2026: topline data from a healthy volunteer study of TTI-109 in Q2 and topline data from a Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) in H2 [1][3] Financial Performance - Research and development expenses for Q4 2025 were $5.5 million, down from $8.6 million in Q4 2024, while total R&D expenses for 2025 were $18.0 million compared to $23.7 million in 2024 [4] - General and administrative expenses for Q4 2025 were $2.1 million, slightly down from $2.2 million in Q4 2024, but increased for the full year to $8.7 million from $4.5 million in 2024 due to higher professional fees related to the merger with Cara Therapeutics [7] - The net loss for Q4 2025 was $7.3 million, an improvement from a net loss of $12.7 million in Q4 2024, with a full-year net loss of $18.2 million compared to $29.4 million in 2024 [8][9] Cash Position - As of December 31, 2025, cash, cash equivalents, and short-term investments totaled $30.8 million, a slight decrease from $31.6 million in 2024, with the company expecting this cash runway to fund operations through Q4 2026 [10] Clinical Trials and Data - The ongoing healthy volunteer study of TTI-109 is expected to yield topline data in Q2 2026, while the Phase 1b/2 REVERT LIVER CANCER trial of TTI-101 will report topline results in the second half of 2026 [5][4] - Interim results from the REVERT IPF Phase 2 trial indicated a 9.4% reduction in fibrosis score for TTI-101 compared to 2.4% for placebo, alongside a 4.5-fold greater decline in IL-6 levels [4]

Core Insights - Tvardi Therapeutics is advancing its clinical pipeline with two significant milestones expected in 2026: topline data from a healthy volunteer study of TTI-109 in Q2 and topline data from a Phase 2 trial of TTI-101 in hepatocellular carcinoma (HCC) in H2 [1][3] Financial Performance - Research and development expenses for Q4 2025 were $5.5 million, down from $8.6 million in Q4 2024, while total R&D expenses for the full year 2025 were $18.0 million compared to $23.7 million in 2024, primarily due to reduced clinical costs for TTI-101 [4] - General and administrative expenses for Q4 2025 were $2.1 million, slightly down from $2.2 million in Q4 2024, but increased for the full year to $8.7 million from $4.5 million in 2024, mainly due to higher professional fees related to the merger with Cara Therapeutics [7] - The net loss for Q4 2025 was $7.3 million, an improvement from a net loss of $12.7 million in Q4 2024, with a full-year net loss of $18.2 million compared to $29.4 million in 2024 [8][9] Cash Position - As of December 31, 2025, cash, cash equivalents, and short-term investments totaled $30.8 million, slightly down from $31.6 million in 2024, with the company expecting this cash runway to fund operations through Q4 2026 [10] Clinical Development Updates - The ongoing Phase 2 REVERT LIVER CANCER trial is expected to report topline results in the second half of 2026, allowing for additional data maturation and insights [5][6] - Preliminary data from the Phase 2 IPF trial of TTI-101 showed a 9.4% reduction in fibrosis score compared to 2.4% for placebo, indicating promising efficacy [5]

Core Insights - Moleculin Biotech, Inc. is advancing its drug candidates Annamycin and WP1066, targeting hard-to-treat tumors and viruses, with significant milestones expected in 2026 [2][3][11] Annamycin Development - Annamycin is set for pivotal Phase 2B/3 MIRACLE trial data readouts in Q1 2026, focusing on second line acute myeloid leukemia (AML) and initiating a trial for pancreatic cancer [3][4] - The MIRACLE trial has expanded to nine countries, with over 46 sites selected and 20 contracted, aiming to treat 45 subjects in Part A by Q1 2026 [3][4] - Annamycin is anticipated to be the first non-cardiotoxic anthracycline, addressing a significant market opportunity as current treatments often lead to heart damage [3][4] Expected Milestones for Annamycin - Q1 2026: Update on non-cardiotoxicity review and unblinding of data for the first 45 subjects [4] - 1H 2026: Recruitment of the 90th subject for the MIRACLE trial [4] - 2027: Begin recruitment for third line AML subjects and pediatric AML clinical study [4] WP1066 Development - WP1066 is designed to stimulate immune response against tumors by inhibiting regulatory T cells and oncogenic transcription factors [5][14] - Ongoing Phase 2 trial for WP1066 in combination with radiation for glioblastoma (GBM) is being conducted at Northwestern University [6][8] - Emory University is conducting a Phase 1 trial with positive results, leading to plans for a follow-on trial [7][8] Expected Milestones for WP1066 - Q1 2026: Continuation of Phase 2 GBM trial at Northwestern [11] - 2H 2026: Initiation of Phase 2 pediatric trial for brain tumors at Emory [11] - 2H 2026: Preclinical data on WP1066 intravenous formulation [11]

Core Points - Tvardi Therapeutics has completed its merger with Cara Therapeutics, transitioning into a publicly traded company listed on Nasdaq under the ticker symbol "TVRD" starting April 16, 2025 [1][2] - The combined company will focus on developing novel oral small molecule therapies targeting STAT3 for fibrosis-driven diseases, with significant unmet medical needs [8][9] - Tvardi expects to have sufficient cash to fund operations into the second half of 2026, following a private placement financing of approximately $28 million and existing cash reserves [3][5] Financial and Operational Highlights - The merger includes a reverse stock split of Cara's shares at a ratio of 1-for-3, resulting in approximately 9.4 million shares of the combined company being issued and outstanding [4][5] - Pre-merger equityholders of Cara will own approximately 15.4% of the combined company's common stock on a fully diluted basis, while Tvardi's pre-merger equityholders will own approximately 84.6% [5] - Tvardi anticipates reporting topline data from two Phase 2 clinical programs in idiopathic pulmonary fibrosis (IPF) and hepatocellular carcinoma (HCC) in the second half of 2025 and the first half of 2026, respectively [1][9] Company Leadership and Recognition - The combined company will be led by Imran Alibhai, Ph.D., as CEO, along with the existing Tvardi management team [1] - Tvardi has been invited to ring the Nasdaq closing bell on April 16, 2025, to celebrate its transition to a publicly traded entity [6]