Monopar Therapeutics Holds $137.5M Cash, Phase 3 ALXN1840 NDA Submission On Track
Monopar reported a $3.9 million first-quarter net loss and held $137.5 million in cash and investments, funding operations through December 2027. The company remains on track for a mid-2026 NDA submission for ALXN1840 after Phase 3 FoCus data showed greater neurologic benefit versus standard of care.
1. ALXN1840 Phase 3 Trial and NDA Timeline
In April 2026, analyses from the randomized controlled Phase 3 FoCus trial demonstrated that ALXN1840 delivered greater neurologic benefits versus standard of care in Wilson disease patients with neurologic symptoms. The company remains on track to submit its New Drug Application to the FDA in mid-2026 and will present these data at the EAN Congress in June and the EASL Congress in May.
2. Q1 2026 Financial Results
For the quarter ended March 31, 2026, Monopar reported a net loss of $3.9 million, or $0.46 per share, compared to a $2.6 million net loss in Q1 2025. R&D expenses rose to $3.49 million from $1.64 million and G&A expenses increased to $1.74 million from $1.58 million, while interest income grew to $1.33 million due to higher treasury holdings and capital raise proceeds.
3. Cash Runway and Commercial Readiness
Cash, cash equivalents and investments totaled $137.5 million as of March 31, 2026, providing funding through at least December 31, 2027. Susan Rodriguez, who joined as Chief Commercial and Strategy Officer in March, is leading preparations for a potential ALXN1840 launch.