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

  • Monopar Therapeutics announced second quarter 2026 financial results & business updates on August 12, 2026.
  • The company initiated a rolling New Drug Application (NDA) submission to the FDA for ALXN1840 on July 22, 2026, & expects to complete it within the next few months.
  • The FDA granted Rare Pediatric Disease designation to ALXN1840 on June 30, 2026, which could result in a Pediatric Priority Review Voucher upon approval.
  • New analyses from the Phase 3 FoCus trial presented at the European Academy of Neurology in June 2026 showed significant neurologic improvement & greater global clinical improvement versus standard-of-care for neurologic Wilson disease patients.
  • Data presented at the EASL Congress in May 2026 demonstrated that ALXN1840 stabilizes liver disease & improves neurological symptoms & quality of life in treatment-experienced Wilson disease patients.
  • A peer-reviewed manuscript published in May 2026 reported that ALXN1840 produced rapid, sustained improvements in daily copper balance driven by increased fecal copper excretion.
  • Susan Rodriguez joined as Chief Commercial & Strategy Officer in March 2026 to lead commercial launch preparations, supported by new Board member Nicole Sweeny & senior executives Sharon Funk & Daniel Olmstead.
  • Cash, cash equivalents, & investments totaled $134.3 million as of June 30, 2026, with funds expected to support operations through at least December 31, 2027.
  • Net loss for the second quarter of 2026 was $5.3 million ($0.62 per share), compared to $2.5 million ($0.35 per share) in the same period of 2025.
  • Research & development expenses increased to $4,766,832 in Q2 2026 from $1,730,000 in Q2 2025, primarily due to higher contractor, consulting, & personnel costs.
  • General & administrative expenses rose to $1,877,831 in Q2 2026 from $1,504,295 in Q2 2025, driven by increases in personnel & contractor expenses.
  • Interest income increased to $1,299,205 in Q2 2026 from $780,769 in Q2 2025, attributed to higher bank balances from a September 2025 capital raise & earnings on U.S. Treasury securities.