Moleculin Accelerates Outlook Into 2026 With First Pivotal Trial Unblinding on Track, Global Trial Expansion, and Multiple Externally/IIT Funded Clinical Programs

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]