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Monopar Therapeutics Reports Third Quarter 2026 Financial Results and Provides Business Updates

  • Monopar Therapeutics announced third quarter 2026 financial results & business updates on November 12, 2026.
  • The company presented baseline findings from the Phase 3 FoCus study of ALXN1840 for Wilson disease at the AASLD Liver Meeting on November 8, 2026.
  • Baseline data showed 39% cirrhosis in treatment-experienced patients & 30% in treatment-naïve patients, with high rates of neurologic & psychiatric symptoms.
  • Only 47% of treatment-experienced patients were within the guideline-recommended copper target range as of November 8, 2026.
  • A poster presented on November 5, 2026, reported neutral molybdenum balance & no molybdenum toxicity over six years of ALXN1840 treatment.
  • Jeffrey D. Kent, M.D., was appointed Executive Vice President, Head of Medical Affairs on August 19, 2026, to lead preparations for potential FDA approval.
  • Monopar initiated a rolling New Drug Application (NDA) submission to the FDA for ALXN1840 on July 22, 2026, with completion expected within several weeks.
  • Cash, cash equivalents, & investments totaled $129.4 million as of September 30, 2026, supporting operations through at least March 31, 2028.
  • The net loss for the third quarter of 2026 was $6.2 million ($0.72 per share), compared to $3.4 million ($0.48 per share) in the same period in 2025.
  • Research & development expenses increased to $4.44 million in the third quarter of 2026 from $2.59 million in 2025, driven by higher contractor & personnel costs.
  • General & administrative expenses rose to $3.03 million in the third quarter of 2026 from $1.50 million in 2025 due to increased personnel & contractor expenses.
  • Interest income for the third quarter of 2026 was $1.27 million, up from $655,473 in 2025, attributed to higher bank balances & Treasury securities.
  • ALXN1840 is a first-in-class albumin tripartite complex activator that demonstrated rapid copper mobilization exceeding standard of care in the pivotal Phase 3 trial.
  • Monopar also maintains radiopharmaceutical programs including MNPR-101-Zr, MNPR-101-Lu, & MNPR-101-Ac for advanced cancers.
Company
Monopar Therapeutics Inc.
Keywords
Nasdaq:MNPR, Monopar Therapeutics Inc., ALXN1840, MNPR, Monopar, Earnings Release