Monopar Therapeutics Reports Second Quarter 2025 Financial Results and Recent Developments

Core Viewpoint - Monopar Therapeutics Inc. reported its second quarter 2025 financial results and highlighted significant developments in its drug pipeline, including the transfer of ALXN1840 for Wilson Disease and ongoing clinical trials for its radiopharmaceutical programs [1][2][3]. Recent Developments - Alexion Pharmaceuticals transferred the sponsorship of the investigational new drug application for ALXN1840 to Monopar, with FDA acknowledgment of this transfer effective from June 6, 2025 [2]. - Monopar is preparing to submit a New Drug Application (NDA) to the FDA in early 2026 [3]. - The company is actively enrolling patients in Phase 1 clinical trials for MNPR-101-Zr and MNPR-101-Lu in Australia, and has an Expanded Access Program for these drugs in the U.S. [4]. Financial Results - As of June 30, 2025, Monopar had cash, cash equivalents, and investments totaling $53.3 million, expected to sustain operations through at least December 31, 2026 [5]. - The net loss for Q2 2025 was $2.5 million, or $0.35 per share, compared to a net loss of $1.7 million, or $0.49 per share, in Q2 2024 [6]. - Research and Development (R&D) expenses increased to $1,730,000 in Q2 2025 from $1,130,978 in Q2 2024, primarily due to higher personnel costs [7]. - General and Administrative (G&A) expenses rose to $1,504,295 in Q2 2025 from $657,806 in Q2 2024, driven by increased Board compensation and legal fees [8]. Interest Income - Interest income for the three months ended June 30, 2025, increased by $707,294 compared to the same period in 2024, attributed to interest earned on U.S. Treasury securities and higher bank balances resulting from over $55 million raised in Q4 2024 [10]. Company Overview - Monopar Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for Wilson disease and advanced cancers through its radiopharmaceutical programs [11].