Business Overview
Leap Therapeutics, Inc. (NASDAQ:LPTX) is a clinical-stage biopharmaceutical company developing novel biomarker-targeted antibody therapies designed to treat patients with cancer. The company's strategy is to identify, acquire, and develop molecules that will rapidly translate into high-impact therapeutics that generate durable clinical benefit and enhanced patient outcomes.Leap Therapeutics' lead clinical stage program is DKN-01, a monoclonal antibody that inhibits Dickkopf-related protein 1 (DKK1). The company is currently studying DKN-01 in multiple ongoing clinical trials in patients with esophagogastric cancer, gynecologic cancers, or colorectal cancer. Leap's second clinical stage program is FL-301, a monoclonal antibody that targets cells that express Claudin18.2 on their cell surface. The company also has two preclinical antibody programs, FL-302 and FL-501.
In January 2020, Leap entered into an Option and License Agreement with BeiGene, Ltd. that granted BeiGene an option to obtain an exclusive license to develop and commercialize DKN-01 in Asia (excluding Japan), Australia, and New Zealand. In March 2023, BeiGene notified Leap that it did not intend to exercise its option, and the agreement is continuing as a clinical collaboration.
Financial Overview
For the fiscal year ended December 31, 2023, Leap reported an annual net loss of $81.4 million and no revenue. The company's annual operating cash flow was -$43.8 million, and its annual free cash flow was also -$43.8 million.In the first quarter of 2024, Leap reported a net loss of $13.8 million. Research and development expenses were $11.3 million, while general and administrative expenses were $3.5 million. The company recorded $0.8 million in interest income and $0.2 million in Australian research and development incentives.
As of March 31, 2024, Leap had cash and cash equivalents of $54.9 million. In April 2024, the company completed a private placement, resulting in net proceeds of approximately $37.2 million. The company believes that its current cash and cash equivalents, together with the net proceeds from the April 2024 Private Placement, will be sufficient to fund its operating expenses for at least the next 12 months.
DKN-01 Development Update
Leap's lead clinical program, DKN-01, has shown promising results in ongoing trials. In January 2024, the company presented initial data from Part A of the DeFianCe study, a Phase 2 trial evaluating DKN-01 in combination with standard of care (SOC) bevacizumab and chemotherapy in second-line patients with advanced microsatellite stable (MSS) colorectal cancer (CRC).Key findings from the DeFianCe Part A study include: - Across all patients enrolled (n=33), the overall response rate (ORR) among response-evaluable patients (n=27) was 30% and the disease control rate (DCR) was 93%, including 8 partial responses (PR) and 17 patients with a best response of stable disease (SD). - Median progression-free survival (PFS) was 6.3 months. - In patients with left-sided tumors (n=25), the ORR was 33% and the DCR was 100%, with a preliminary median PFS of 8.6 months. - In patients with rectal/rectosigmoid carcinomas (n=15), the ORR was 46% and the DCR was 100%, with a preliminary median PFS of 9.4 months. - Higher baseline plasma DKK1 levels correlated with improved responses. - DKN-01 plus bevacizumab and chemotherapy was well-tolerated, with a majority of DKN-01-related events being low grade (Grade 1/2).
Part B of the DeFianCe study, which has been expanded to 180 patients, is ongoing, with enrollment expected to be completed in late Q3 or early Q4 2024. The company expects to report data from Part B in mid-2025.
Leap also announced the completion of enrollment in the randomized controlled Part C of the DisTinGuish study, which is evaluating DKN-01 in combination with tislelizumab, BeiGene's anti-PD-1 antibody, and chemotherapy in first-line patients with advanced gastroesophageal junction and gastric cancer. The company expects to report initial data from Part C in the second half of 2024 or early 2025.