Monopar Therapeutics Reports $2.6 Million Net Loss in Q1 2025, Increases R&D and G&A Expenses

Monopar Therapeutics Inc. reported a net loss of $2.6 million for the first quarter of 2025, compared to a loss of $1.6 million in the same period of 2024, reflecting an increase in operating expenses. Total operating expenses rose to $3.2 million, up from $1.7 million year-over-year, driven primarily by higher research and development (R&D) costs, which increased to $1.6 million from $966,000, and general and administrative (G&A) expenses, which rose to $1.6 million from $757,000. The company’s cash and cash equivalents decreased to $39.7 million as of March 31, 2025, down from $45.8 million at the end of 2024.

The increase in losses and expenses is attributed to a significant rise in personnel costs and clinical trial activities related to Monopar's radiopharmaceutical programs. The company also incurred a $3 million payment related to the ALXN1840 program, which it licensed from Alexion Pharmaceuticals in late 2024. This program is aimed at treating Wilson disease, a rare genetic disorder. Despite the financial losses, Monopar's management believes that the available cash will be sufficient to fund operations through at least December 31, 2026.

In terms of strategic developments, Monopar has made significant progress in its clinical programs. The company is advancing its proprietary monoclonal antibody MNPR-101, which targets the urokinase plasminogen activator receptor (uPAR) for use in imaging and treating advanced cancers. The Phase 1 clinical trials for both MNPR-101-Zr and MNPR-101-Lu are currently active, with the first patient dosed in December 2024. Additionally, Monopar is preparing to submit a New Drug Application (NDA) for ALXN1840 in early 2026, following positive data from previous clinical trials.

Operationally, Monopar has not generated any revenue to date, as it remains focused on the development of its product candidates. The company has not reported any significant changes in customer counts or market share, as it is still in the clinical development phase. The total number of shares outstanding as of March 31, 2025, was 6,115,214, following a reverse stock split that took effect in August 2024. Monopar's management continues to assess opportunities for geographic expansion and potential partnerships to enhance its product pipeline and market presence.

Looking ahead, Monopar anticipates continued financial losses as it invests in the development of its drug candidates. The company is actively seeking additional funding through various means, including equity offerings and strategic collaborations, to support its ongoing clinical trials and operational needs. The management team remains focused on executing its strategic plan to bring innovative treatments to market, particularly in the areas of rare diseases and oncology.