Financial Performance - The company reported a net loss of 29.8 million in 2023[26]. - The weighted average common shares outstanding increased to 3,442,997 in 2024 from 1,975,610 in 2023[26]. Expenses - Research and development (R&D) expenses for the year ended December 31, 2024, were 1.8 million from 19.5 million in 2023[14]. - General and administrative (G&A) expenses decreased to 8.8 million in 2024 from 4.3 million, which, along with $9.3 million from February 2025 financing, is expected to fund operations into Q3 2025[16]. Clinical Trials - The company expects to unblind preliminary data from the first 45 subjects in the MIRACLE trial in the second half of 2025[2]. - The MIRACLE trial will randomize 75 to 90 subjects to receive either high dose cytarabine combined with placebo or Annamycin, with the first unblinding expected in the second half of 2025[5]. - The company completed enrollment in the Phase 2 portion of its U.S. Phase 1B/2 clinical trial for Annamycin as monotherapy for soft tissue sarcoma lung metastases, with a clinical study report expected by the end of April 2025[10]. Regulatory Status - The company received positive FDA guidance for the MIRACLE trial, allowing for a smaller number of subjects in the study[6]. - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia[11].
Moleculin(MBRX) - 2024 Q4 - Annual Results