Monopar Therapeutics Inc. reported significant financial developments in its recent 10-K filing for the fiscal year ending December 31, 2024. The company, which focuses on developing treatments for Wilson disease and radiopharmaceuticals for oncology, recorded a net loss of $15.6 million, an increase from a net loss of $8.4 million in the previous year. This reflects a substantial rise in operating expenses, which totaled $16.2 million, compared to $8.8 million in 2023. The increase in expenses was primarily driven by a $8.6 million rise in research and development costs associated with the in-licensing of ALXN1840, a drug candidate for Wilson disease.

In terms of liquidity, Monopar reported cash, cash equivalents, and investments totaling $60.2 million as of December 31, 2024, a significant increase from $7.3 million at the end of 2023. This increase was largely due to successful financing activities, including a public offering that generated approximately $17.8 million and a concurrent private placement of pre-funded warrants that raised about $37.4 million. The company anticipates that its current funds will be sufficient to support operations through at least December 31, 2026, as it continues to advance its clinical programs.

Strategically, Monopar has made notable moves, including acquiring an exclusive worldwide license for ALXN1840 from Alexion Pharmaceuticals in October 2024. This agreement includes milestone payments of up to $94 million and tiered royalties based on net sales. Additionally, the company is actively developing its MNPR-101 radiopharmaceutical program, which includes ongoing Phase 1 clinical trials for both imaging and therapeutic applications in advanced cancers. The company has also filed a provisional patent application for new radiopharmaceutical compounds, indicating a commitment to expanding its product pipeline.

Operationally, Monopar's workforce has grown to 16 employees, with plans to hire additional personnel in regulatory affairs and clinical operations to support its expanding development efforts. The company is currently conducting clinical trials in Australia, with early data from its MNPR-101-Zr imaging agent showing promising results in targeting tumors. Looking ahead, Monopar aims to submit a New Drug Application (NDA) for ALXN1840 to the FDA in early 2026, while continuing to advance its radiopharmaceutical programs and explore further opportunities for growth through internal development and potential acquisitions.

About Monopar Therapeutics

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