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GlobeNewswire·

Monopar Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Business Update

  • Monopar Therapeutics announced fourth quarter & full-year 2025 financial results & provided updates on recent program developments.
  • The company plans to submit a New Drug Application for ALXN1840 to treat Wilson disease in mid-2026 following recent FDA interactions.
  • ALXN1840 data presented at EASL 2025 & ANA 2025 demonstrated long-term efficacy, safety, & neurological benefits, with further presentations scheduled for EASL 2026 & AAN 2026.
  • An FDA patient-focused drug development meeting occurred on January 29, 2026, highlighting the urgent need for additional Wilson disease treatments.
  • The MNPR-101 radiopharmaceutical platform targets aggressive cancers via the uPAR receptor, with Phase 1 trials ongoing in Australia & IND clearance received for US trials of MNPR-101-Lu.
  • Monopar completed an underwritten public offering in 2025 that generated approximately $91.9 million, strengthening its balance sheet.
  • Cash, cash equivalents, & short-term investments totaled $140.4 million as of December 31, 2025, supporting operations through at least December 31, 2027.
  • Net loss for Q4 2025 was $5.2 million, decreasing from $10.9 million in Q4 2024, while the full-year 2025 net loss was $13.7 million compared to $15.6 million in 2024.
  • Research & development expenses decreased in Q4 2025 ($3.9 million) & for the full year 2025 ($9.9 million) primarily due to the absence of one-time in-licensing costs for ALXN1840 from 2024.
  • General & administrative expenses increased in Q4 2025 ($2.2 million) & for the full year 2025 ($6.8 million) driven by higher personnel costs, stock-based compensation, & patent legal fees.
  • Susan Rodriguez was appointed as Chief Commercial & Strategy Officer to support the leadership team ahead of a potential ALXN1840 launch.