Leap Therapeutics Reports $15.4 Million Net Loss in Q1 2025, Increases R&D Spending

Leap Therapeutics, Inc. reported a net loss of $15.4 million for the first quarter of 2025, compared to a net loss of $13.8 million for the same period in 2024. The company's total operating expenses increased to $15.9 million from $14.8 million year-over-year, primarily driven by a rise in research and development costs, which reached $12.9 million, up from $11.3 million. This increase was attributed to higher clinical trial costs associated with the ongoing development of the company's lead product candidate, sirexatamab (DKN-01), as well as increased manufacturing expenses.

In terms of financial position, Leap Therapeutics reported cash and cash equivalents of $32.7 million as of March 31, 2025, a decrease from $47.2 million at the end of 2024. The company’s accumulated deficit grew to $482.8 million, reflecting ongoing operational losses. The decrease in cash reserves was primarily due to cash used in operating activities, which amounted to $14.5 million for the quarter, slightly less than the $15.5 million used in the same quarter of the previous year.

Strategically, Leap Therapeutics has made significant organizational changes, including a workforce reduction of approximately 50% to streamline operations and focus on the clinical development of sirexatamab and the preclinical program FL-501. This restructuring is expected to incur one-time costs between $350,000 and $450,000, primarily related to severance and termination benefits. The company is also exploring business development opportunities to further advance the development of sirexatamab, which has shown promising results in clinical trials for colorectal cancer.

Operationally, Leap Therapeutics continues to focus on its clinical trials, with the DeFianCe study of sirexatamab showing statistically significant improvements in overall response rates and progression-free survival in certain patient populations. The company is preparing for a potential registrational Phase 3 trial based on these encouraging results. However, the company has not yet generated any revenue from product sales and remains dependent on external funding to support its ongoing research and development efforts.

Looking ahead, Leap Therapeutics anticipates continued operating losses as it invests in the development of its product candidates. The company plans to seek additional funding through public or private equity financing and collaboration agreements to support its operations. The ability to secure this funding will be critical to the company's future prospects, as it aims to navigate the complexities of drug development and regulatory approval processes.