Moleculin(US:MBRX)2025-05-13 20:15Clinical Trials and Development - The company is conducting a pivotal Phase 3 trial for Annamycin in combination with Cytarabine for relapsed/refractory acute myeloid leukemia (AML), with interim unblinding expected by the end of 2025[74]. - Annamycin has shown no evidence of cardiotoxicity in 84 subjects treated across five clinical trials, with some subjects receiving doses significantly above the FDA's lifetime maximum anthracycline limit of 550 mg/m²[81]. - The MIRACLE trial has received approval from the European Medicines Agency (EMA) to expand into nine EU countries, contingent on presenting results of appropriate nonclinical GLP studies before initiating Part B[91]. - The FDA has allowed a reduction in the size of Part B of the Phase 3 trial protocol to 222 subjects, which is approximately a 10% decrease from the initial proposal[89]. - The company has completed a Phase 1B/2 clinical trial for Annamycin treating Acute Myeloid Leukemia (AML) and is currently in follow-up[85]. - The company has selected 38 sites for the MIRACLE trial across the US, Europe, and the Middle East/Africa, with one site in Ukraine actively treating subjects[88]. - Annamycin is designed to avoid multidrug resistance and has shown no cardiotoxicity in clinical trials, which could disrupt the competitive landscape for AML and Advanced STS treatments[76]. - The company has multiple active INDs/CTAs, comprising a total of fourteen clinical trials, both internally and externally funded[85]. - The company plans to host a Key Opinion Leader (KOL) call to announce and review final top-line data from the MB-107 trial in May or early June[92]. - The company is focusing on the development of Annamycin due to its potential to benefit a majority of patients with AML and Advanced STS[76]. Financial Performance - Revenues for the three months ended March 31, 2025, were $0, consistent with the same period in 2024[105]. - Research and development expenses decreased to $3.4 million in Q1 2025 from $4.3 million in Q1 2024, a reduction of approximately 21%[106]. - General and administrative expenses increased slightly to $2.5 million in Q1 2025 from $2.4 million in Q1 2024, reflecting a 4% increase[107]. - The net loss for the three months ended March 31, 2025, was $6.4 million, compared to a net loss of $5.0 million in the same period of 2024, representing a 29% increase in losses[105]. - The company recorded a net gain of $9.1 million from the change in fair value of warrant liability in Q1 2025, compared to a gain of $1.5 million in Q1 2024[108]. - Cash used in operating activities decreased to $4.6 million in Q1 2025 from $6.7 million in Q1 2024, a decrease of approximately 31%[112]. - The company raised gross proceeds of $9.3 million in February 2025 through various securities offerings[114]. - As of March 31, 2025, the company had $0.6 million in cash on hand and projected sufficient funds to support operations into Q3 2025[116]. - The company anticipates needing approximately $15 million in additional funding to support operations into Q1 2026[116]. Regulatory and Naming Approvals - The World Health Organization approved "naxtarubicin" as the International Non-Proprietary Name for Annamycin, facilitating its recognition in clinical and public documents[99].