Monopar Therapeutics

Monopar Therapeutics announced new analyses from its Phase 3 FoCus trial for ALXN1840 (tiomolibdate choline) in Wilson disease patients. The data, presented at EAN 2026, demonstrated greater neurologic and global clinical benefit compared to standard of care, along with a favorable safety profile. These results further support the company's planned New Drug Application submission to the FDA in mid-2026.

Monopar Therapeutics announced new analyses from its Phase 3 FoCus trial for ALXN1840 (tiomolibdate choline) in Wilson disease patients with neurologic symptoms. The data, presented at EAN 2026, showed ALXN1840 produced significant neurologic improvement over time and greater global clinical improvement compared to standard-of-care. The drug also demonstrated similar or better outcomes across psychiatric and hepatic measures, with a favorable safety profile. These results further support the company's planned New Drug Application submission to the FDA in mid-2026.

Monopar Therapeutics announced positive Phase 2 data for ALXN1840 (tiomolibdate choline) in treatment-experienced Wilson disease patients, presented at EASL Congress 2026. The trial showed stabilization or improvement in liver pathology in a high percentage of patients, alongside significant improvements in neurological symptoms, global clinical status, and quality of life. ALXN1840 was also generally well tolerated, reinforcing its potential to address unmet medical needs in this patient population.

Monopar Therapeutics Inc. announced the presentation of Phase 2 study results for ALXN1840 (tiomolibdate choline) at the European Association for the Study of the Liver (EASL) International Liver Congress 2026. The study, identified as NCT04422431, evaluated the drug's effect on liver pathology and clinical symptoms in patients with Wilson disease. The presentation document was included as Exhibit 99.1 in the 8-K filing.

Monopar Therapeutics announced the publication of peer-reviewed Phase 2 trial results for ALXN1840 (tiomolibdate choline) in Hepatology Communications. The study demonstrated that ALXN1840 rapidly and significantly improved daily copper balance in patients with Wilson disease, driven by increased fecal copper excretion. These positive findings, including good tolerability and efficacy even in previously treated patients, reinforce ALXN1840's potential as a new treatment option for this rare genetic condition.

Monopar Therapeutics announced the publication of positive Phase 2 ALXN1840-WD-204 study results in Hepatology Communications. The study demonstrated that ALXN1840 (tiomolibdate choline) produced a rapid, statistically significant, and sustained improvement in daily copper balance in patients with Wilson disease, primarily driven by increased fecal copper excretion. The drug was generally well tolerated with no serious adverse events, and these improvements were observed even in patients with long prior treatment durations, suggesting its ability to mobilize residual copper.

Monopar Therapeutics reported a net loss of $(3.89) million, or $(0.46) per share, for the three months ended March 31, 2026, compared to a net loss of $(2.62) million, or $(0.38) per share, in the prior year period. The company's cash and cash equivalents decreased to $52.54 million from $61.83 million at year-end 2025. Despite a pivotal Phase 3 trial meeting its primary endpoint, Alexion terminated the ALXN1840 program for Wilson disease, leading Monopar to focus on submitting an NDA with uncertain outcomes. Management projects current cash will fund operations through December 31, 2027.

Monopar Therapeutics announced its first quarter 2026 financial results, reporting a net loss of $3.9 million, or $0.46 per share, compared to a net loss of $2.6 million in Q1 2025. The company maintained a strong cash position of $137.5 million as of March 31, 2026, which is expected to fund operations through December 31, 2027. Additionally, Monopar confirmed that the New Drug Application (NDA) submission for ALXN1840 for Wilson Disease remains on track for mid-2026, following positive Phase 3 FoCus trial data presentations at the AAN Annual Meeting and upcoming presentations at EAN and EASL Congresses.

Monopar Therapeutics Inc. announced its Annual Meeting of Stockholders to be held on June 22, 2026. Stockholders will consider and vote on the election of six directors, an advisory resolution on executive compensation, the approval of the Company's 2026 Stock Incentive Plan, and the ratification of BPM LLP as the independent registered public accounting firm. The 2026 Stock Incentive Plan proposes to add 600,000 new shares, representing 9.2% of the fully-diluted common stock outstanding. The Board of Directors unanimously recommends voting "FOR" all proposals.