Leap Therapeutics Reports Promising Clinical Data and Exploring Strategic Alternatives

Leap Therapeutics reports promising Phase 2 DeFianCe study results for sirexatamab in colorectal cancer, with median progression-free survival improvements in high DKK1 and VEGF-naive patients. Despite positive outcomes, financial constraints lead to a 75% workforce reduction and exploration of strategic alternatives, including a potential sale or partnership for sirexatamab and FL-501, with Raymond James engaged as the exclusive financial advisor. Leap has a $32.7 million cash reserve and is projecting restructuring costs of approximately $3.2 million for Q3 2025.

Leap Therapeutics, Inc. (Nasdaq: LPTX) recently reported updated results from its Phase 2 DeFianCe study evaluating sirexatamab in colorectal cancer, demonstrating statistically significant improvements in progression-free survival (PFS) among high DKK1, VEGF-naïve, and liver metastasis subgroups. Despite these promising clinical outcomes, the company is facing financial constraints that have led to a significant workforce reduction and the exploration of strategic alternatives, including potential sales or partnerships for sirexatamab and FL-501.

The updated data from the DeFianCe study, as of May 22, 2025, showed a positive trend on overall response rate (ORR) and PFS in the full second-line CRC population, driven by statistically significant benefits in specific patient subgroups. The median PFS was 9.2 months in the sirexatamab arm compared to 8.31 months in the control arm, with a hazard ratio (HR) of 0.84 (95% CI: 0.57, 1.22, p = 0.1749). The ORR by investigator assessment (IA) was 35.1% in the sirexatamab arm compared to 26.6% in the control arm (p = 0.1009).

Leap Therapeutics has initiated a 75% workforce reduction to preserve capital, with restructuring costs estimated at approximately $3.2 million for Q3 2025. The company's cash and cash equivalents totaled $32.7 million as of March 31, 2025. To maximize shareholder value, Leap has engaged Raymond James & Associates, Inc. as the exclusive financial advisor to explore strategic alternatives, including leveraging its cash balance and potential sales or partnerships for its product candidates.

The company's most advanced clinical candidate, sirexatamab (DKN-01), is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, while FL-501 is a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein in preclinical development. Leap's pipeline includes targeted and immuno-oncology therapeutics focused on colorectal cancer.

Leap's forward-looking statements include the potential safety, efficacy, and regulatory progress of sirexatamab and FL-501, as well as the cost and timeline to complete the DeFianCe Study and wind-down clinical operations. The company's ability to successfully sell or enter into partnerships for these products, along with the magnitude, timing, and costs associated with the workforce reduction, are critical factors that could impact the company's future performance.

References:
[1] Leap Therapeutics Reports Updated Clinical Data from Sirexatamab Colorectal Cancer Study and Announces Exploration of Strategic Alternatives. (2025, June 23). Retrieved from https://investors.leaptx.com/news-releases/news-release-details/leap-therapeutics-reports-updated-clinical-data-sirexatamab
[2] Leap Therapeutics Reports Updated Clinical Data from Sirexatamab Colorectal Cancer Study and Announces Exploration of Strategic Alternatives. (2025, June 23). Retrieved from https://www.gurufocus.com/news/2938674/leap-therapeutics-reports-updated-clinical-data-from-sirexatamab-colorectal-cancer-study-and-announces-exploration-of-strategic-alternatives-lptx-stock-news