Monopar Therapeutics Inc., a clinical-stage biotechnology company, reported its financial results for the three and nine months ended September 30, 2024, highlighting continued operational losses and strategic developments. The company has not generated any revenue from product sales to date and anticipates significant increases in expenses due to ongoing development activities.

For the three months ended September 30, 2024, Monopar recorded a net loss of $1.3 million, a decrease from $1.95 million in the same period in 2023. The loss per share improved to $(0.37) from $(0.69) year-over-year. Total operating expenses for the quarter were $1.57 million, down from $2.07 million in the prior year, reflecting a reduction in research and development (R&D) expenses, which totaled $984,000 compared to $1.32 million in 2023.

For the nine months ended September 30, 2024, the net loss was $4.66 million, down from $6.59 million in the same period in 2023. The loss per share for this period was $(1.36), an improvement from $(2.43) in the previous year. Total operating expenses decreased to $5.09 million from $6.92 million, with R&D expenses also declining to $3.08 million from $4.56 million.

As of September 30, 2024, Monopar's cash and cash equivalents totaled $6.02 million, down from $7.27 million at the end of 2023. The company reported total stockholders’ equity of $4.95 million, a decrease from $5.59 million at year-end 2023. The accumulated deficit stood at approximately $64.9 million.

Strategically, Monopar has faced challenges with its ALXN-1840 program for Wilson disease, which was terminated despite meeting primary endpoints in a pivotal Phase 3 trial. The company is now focused on assembling a regulatory package and engaging with the FDA, which may require additional studies and capital. In October 2024, Monopar executed a license agreement with Alexion Pharmaceuticals for ALXN-1840, which includes an upfront cash payment of $4 million and potential milestone payments totaling up to $94 million.

Additionally, Monopar is advancing its radiopharmaceutical programs, including MNPR-101-Zr and MNPR-101-Lu, with ongoing clinical trials showing promising early data. The company is also exploring opportunities to expand its pipeline and has plans to seek additional capital within the next 12 months to support its operations and clinical development.