ALXN1840

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Monopar Announces ALXN1840 Data Selected for Late-Breaker Presentation at EASL Congress 2025
Globenewswire· 2025-04-29 12:00
Core Viewpoint - Monopar Therapeutics Inc. has announced that data on the long-term efficacy and safety of its drug candidate ALXN1840 for Wilson disease will be presented at the EASL International Liver Congress 2025, highlighting the significance of this research in the hepatology field [1][2]. Group 1: Presentation Details - The late-breaker poster presentation will focus on "Sustained long-term clinical improvement in Wilson disease patients on tiomolybdate choline" [3]. - The presentation is scheduled for May 7, 2025, at 8:30 a.m. CET, and will be led by Dr. Karl Heinz Weiss [3]. - The poster will be available online on the company's website on the same day [3]. Group 2: Company Overview - Monopar Therapeutics is a clinical-stage biotechnology company with a focus on developing innovative treatments, including ALXN1840 for Wilson disease and various radiopharmaceutical programs for advanced cancers [4].
Monopar Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Developments
Newsfilter· 2025-03-31 12:00
Core Viewpoint - Monopar Therapeutics Inc. reported a productive year in 2024, highlighted by the in-licensing of ALXN1840, initiation of two Phase 1 clinical trials, and a strengthened balance sheet with over $55 million in net proceeds from financings [2][3]. Recent Program Developments - The company plans to submit a New Drug Application (NDA) for ALXN1840 targeting Wilson disease in early 2026, following a successful Phase 3 clinical trial [3]. - ALXN1840 is a potent copper binder and mobilizer, addressing a rare genetic condition that leads to toxic copper accumulation [3]. - Monopar has executed a worldwide exclusive license for ALXN1840 with Alexion, which included a cash payment of $4 million and a 9.9% equity stake in Monopar [3]. Clinical Trials - MNPR-101 is currently enrolling in Phase 1 imaging and therapeutic oncology trials, targeting aggressive cancers through its imaging agent MNPR-101-Zr and therapeutic agent MNPR-101-Lu [4]. Recent Financings - In Q4 2024, Monopar raised over $55 million through various financings, including public offerings and private placements [5]. - The company dosed its first patient with MNPR-101-Lu in December 2024 and presented promising clinical data at the EANM 2024 Annual Congress [5]. Financial Results - As of December 31, 2024, Monopar reported cash and short-term investments of $60.2 million, sufficient to fund operations through at least December 31, 2026 [6]. - The net loss for Q4 2024 was $10.9 million, compared to $1.8 million in Q4 2023, while the annual net loss for 2024 was $15.6 million, up from $8.4 million in 2023 [7]. Research and Development Expenses - R&D expenses for Q4 2024 were $9.9 million, significantly higher than $1.0 million in Q4 2023, primarily due to the in-licensing of ALXN1840 [8]. - For the year ended December 31, 2024, R&D expenses totaled $13.0 million, compared to $5.6 million in 2023, reflecting increased investment in clinical programs [9]. General and Administrative Expenses - G&A expenses for Q4 2024 were $1.2 million, up from $0.9 million in Q4 2023, attributed to increases in personnel salaries and consulting fees [10]. - For the full year 2024, G&A expenses remained stable at $3.2 million compared to 2023 [11].