Leap Therapeutics Reports Updated Clinical Data from Sirexatamab Colorectal Cancer Study and Announces Exploration of Strategic Alternatives

Core Viewpoint - Leap Therapeutics is exploring strategic alternatives to maximize shareholder value following updated positive results from the DeFianCe study, which demonstrated significant benefits of sirexatamab in specific patient subgroups with advanced colorectal cancer [1][2][7]. Study Results - The DeFianCe study (NCT05480306) showed that sirexatamab, in combination with bevacizumab and chemotherapy, provided statistically significant improvements in progression-free survival (PFS) and overall response rate (ORR) among patients with high DKK1 levels, no prior anti-VEGF therapy, or liver metastasis [1][3]. - In the intent-to-treat population (n=188), the median PFS for the sirexatamab arm was 9.2 months compared to 8.31 months for the control arm, with a hazard ratio (HR) of 0.84 [3]. - For patients with high DKK1 levels (n=44), the median PFS was 9.36 months for the sirexatamab arm versus 5.88 months for the control arm, with a significant p-value of 0.0237 [4]. - In patients who had not received prior anti-VEGF therapy (n=95), the median PFS was 11.2 months for the sirexatamab arm compared to 8.34 months for the control arm, with a p-value of 0.0383 [5]. Corporate Actions - Due to current market conditions, Leap Therapeutics has decided to wind down the DeFianCe clinical trial and implement a workforce reduction of approximately 75%, with estimated costs of $3.2 million related to severance payments [2][6]. - The company has engaged Raymond James & Associates, Inc. as an exclusive financial advisor to assist in exploring strategic alternatives, including potential sales or partnerships for sirexatamab and FL-501 [7]. - As of March 31, 2025, Leap's cash and cash equivalents totaled $32.7 million, indicating a need for strategic financial management [6].