Monopar Therapeutics (MNPR) Q1 2026 earnings summary

Executive summary

• Clinical-stage biopharma focused on ALXN1840 for Wilson disease and MNPR-101 radiopharmaceuticals for oncology, with late-stage and early clinical programs active as of Q1 2026.

• Presented new Phase 3 Focus trial data for ALXN1840, showing greater neurologic benefit versus standard of care in Wilson disease patients with neurologic symptoms at baseline.

• NDA submission for ALXN1840 remains on track for mid-2026, with commercial readiness activities underway.

• No revenue generated to date; operations funded by equity offerings, including a major capital raise in September 2025 and share repurchase.

• Cash, cash equivalents, and investments totaled $137.5 million as of March 31, 2026, expected to fund operations through at least December 2027.

Financial highlights

• Net loss for Q1 2026 was $3.9 million ($0.46 per share), compared to $2.6 million ($0.38 per share) in Q1 2025, driven by increased R&D and G&A expenses.

• R&D expenses rose to $3.5 million (up $1.8 million year-over-year), mainly due to higher contractor, consulting, and personnel costs.

• G&A expenses increased to $1.74 million (up $0.16 million year-over-year), primarily from higher personnel costs.

• Interest income increased to $1.33 million, reflecting higher balances from recent capital raises.

• Cash used in operations was $3.5 million for Q1 2026, with a net cash outflow of $9.3 million including investing and financing activities.

Outlook and guidance

• Current funds expected to support operations through December 2027, covering NDA submission for ALXN1840 and ongoing clinical trials for MNPR-101 programs.

• NDA submission for ALXN1840 anticipated in mid-2026, pending further FDA dialogue, with commercial launch preparations ongoing.

• Ongoing investment in expanding the radiopharmaceutical pipeline and internal R&D projects.