Monopar Therapeutics Reports $2.5 Million Net Loss in Q2 2025, Increases R&D and G&A Expenses

Monopar Therapeutics Inc. reported a net loss of $2.5 million for the three months ended June 30, 2025, compared to a loss of $1.7 million for the same period in 2024, reflecting an increase in operating expenses. Total operating expenses for the second quarter of 2025 reached $3.2 million, up from $1.8 million in the prior year, driven primarily by higher research and development (R&D) and general and administrative (G&A) costs. R&D expenses increased to $1.7 million from $1.1 million, while G&A expenses rose to $1.5 million from $657,000. For the first half of 2025, the company reported a net loss of $5.1 million, compared to a loss of $3.4 million in the same period of 2024.

The company’s financial position showed a decrease in cash and cash equivalents, which totaled $39.5 million as of June 30, 2025, down from $45.8 million at the end of 2024. Monopar's total assets also declined to $53.9 million from $60.3 million over the same period. The accumulated deficit increased to approximately $80.9 million, indicating ongoing financial challenges as the company continues to invest in its clinical programs without generating revenue.

Strategically, Monopar has focused on advancing its product pipeline, particularly the investigational drug ALXN1840 for Wilson disease, which it licensed from Alexion Pharmaceuticals in late 2024. The company is preparing to submit a New Drug Application (NDA) for ALXN1840 in early 2026, following positive data from previous clinical trials. Additionally, Monopar is developing its radiopharmaceutical programs, including MNPR-101-Zr and MNPR-101-Lu, which are currently in Phase 1 clinical trials for imaging and therapeutic applications in advanced cancers.

Operationally, Monopar has made significant strides in its clinical development efforts, including the initiation of a physician-sponsored Expanded Access Program for its investigational agents. The company is also exploring opportunities to expand its pipeline through internal development and potential acquisitions. As of June 30, 2025, Monopar had 6,127,457 shares of common stock outstanding, reflecting a reverse stock split that took effect in August 2024. The company anticipates that its current cash reserves will be sufficient to fund operations through at least December 31, 2026, as it continues to seek additional funding sources to support its ongoing clinical and regulatory activities.