ALXN1840 (WTX101) - (FoCus)

May 14, 2026: Monopar Therapeutics Inc. (NASDAQ: MNPR) reported Q1 2026 financial results and provided a regulatory/clinical update on ALXN1840 (tiomolibdate choline, TMC) for Wilson disease. The company said it remains on track to submit an FDA New Drug Application (NDA) in mid-2026. In April 2026, Monopar presented new analyses from the randomized, controlled Phase 3 FoCus trial at the AAN Annual Meeting 2026, reporting greater neurologic benefit for ALXN1840 versus standard of care in Wilson disease patients with neurologic symptoms at baseline. Additional FoCus trial poster presentations are planned at EASL Congress 2026 (Barcelona, May 27–30; presentation May 29 at 08:45 CEST) and at the 12th European Academy of Neurology (EAN) Congress (Geneva, June 27–30; presentation June 28 at 12:50 CEST).

Financial highlights: cash, cash equivalents and investments were $137.5 million as of March 31, 2026; net loss was $3.9 million ($0.46/share). The company expects current funds to support operations through at least Dec. 31, 2027, including ALXN1840 regulatory/potential commercial activities and development of MNPR-101 radiopharmaceutical programs (MNPR-101-Zr Phase 1 imaging; MNPR-101-Lu Phase 1a; MNPR-101-Ac late preclinical) in advanced cancers.