Monopar Therapeutics (NASDAQ: MNPR)

Monopar Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing a novel oral treatment for Wilson disease and a series of radiopharmaceutical candidates for oncology. The company’s lead program is ALXN1840 an investigational once daily oral drug designed to bind and remove excess copper in patients with Wilson disease. Its second platform centers on MNPR 101 a humanized monoclonal antibody that can be linked to zirconium 89 lutetium 177 or actinium 225 to create imaging and therapeutic agents that target the urokinase plasminogen activator receptor expressed on many aggressive tumors. Monopar advances these programs through internal research and through licensing of late stage preclinical and clinical assets.

Monopar Therapeutics Inc. does not currently generate revenue from product sales because its candidates are still in clinical development. The company receives income from licensing agreements that include upfront cash payments, milestone payments upon regulatory or sales achievements and royalty rights on future net sales. For example the company has secured an exclusive worldwide license for ALXN1840 from Alexion which involved an upfront cash payment and future milestone obligations. Additionally Monopar has entered into supply and collaboration agreements that may provide further financial support as programs advance.

The company operates through the following segments: Wilson disease therapy and Radiopharmaceutical oncology.

• Wilson disease therapy segment focuses on ALXN1840 a small molecule that binds copper and promotes its excretion. The drug has received Orphan Drug Designation in the United States and the European Union and Fast Track status from the U. S. Food and Drug Administration. Clinical development includes a Phase 3 trial that demonstrated superior copper mobilization compared to standard of care and ongoing long term data showing sustained neurologic and hepatic benefit. The company now holds worldwide rights to ALXN1840 after acquiring the license from Alexion and is preparing a new drug application for submission in mid 2026.

• Radiopharmaceutical oncology segment centers on MNPR 101 a humanized monoclonal antibody that can be conjugated with zirconium 89 lutetium 177 or actinium 225 to create imaging and therapeutic agents. The program targets the urokinase plasminogen activator receptor which is overexpressed in many solid tumors such as breast pancreatic ovarian and bladder cancers. Preclinical studies show selective tumor uptake and anti tumor activity in animal models. The company is conducting a Phase 1 imaging trial with MNPR 101 zirconium 89 and a Phase 1a therapy trial with MNPR 101 lutetium 177 in Australia and has opened an expanded access program in the United States for eligible patients.

In the Wilson disease space Monopar faces competition from established chelation therapies such as penicillamine and trientine and from zinc supplements that limit copper absorption. The company’s advantage lies in the novel mechanism of ALXN1840 which directly removes copper and has shown superior mobilization in clinical trials along with orphan drug and fast track designations that may facilitate regulatory review. In the radiopharmaceutical oncology arena Monopar contends with large pharmaceutical companies and specialized biotech firms that are developing similar targeting agents. Its differentiation comes from the use of the urokinase plasminogen activator receptor as a target and from the flexibility to attach different radioisotopes for imaging or therapy which may allow a personalized approach to treatment.

Monopar Therapeutics Inc. serves patients with Wilson disease who are under the care of hepatologists neurologists and genetic specialists. For its radiopharmaceutical candidates the company intends to work with hospitals imaging centers and oncology clinics that provide nuclear medicine services. No specific customer names are disclosed in the filing.