Leap Therapeutics Q2 2024 Financial Results

Leap Therapeutics, Inc., a biotechnology firm focusing on targeted and immuno-oncology therapies, has announced its financial results for the second quarter ending June 30, 2024.

Key Developments:

The company reported an improvement in the overall response rate (ORR) to 33% among all evaluable patients and 38% among those with left-sided colorectal cancer (CRC) in updated data from Part A of their Phase 2 DeFianCe study. This study assesses the efficacy of DKN-01 combined with bevacizumab and chemotherapy in second-line patients with advanced CRC. The randomized controlled Part B of the DeFianCe study has been expanded to 180 patients, with enrollment expected to be complete by late September 2024 and data anticipated by mid-2025.

Furthermore, patient follow-up continues in the randomized controlled Part C of the Phase 2 DisTinGuish study, which evaluates DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer. Data from this study is expected by late 2024 or early 2025.

Additionally, Leap Therapeutics completed a $40 million private placement with new and existing investors, including Gilead Sciences, Inc. President and CEO Douglas E. Onsi noted that the funding positions the company to meet its critical milestones. He highlighted their successful execution of the two randomized controlled trials and preparatory activities for registrational studies.

DKN-01 Development:

The updated findings from Part A of the DeFianCe Study showed notable efficacy. The study evaluates DKN-01, a humanized monoclonal antibody targeting Dickkopf-1 (DKK1) protein, combined with bevacizumab and chemotherapy, in second-line patients with advanced microsatellite stable CRC. Preliminary results were previously presented at the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. A ninth patient in Part A, with left-sided Consensus Molecular Subtype 4 CRC, achieved a partial response after being on stable disease for over a year. This patient remains on the study with a confirmed partial response.

As of the June 7, 2024 data cut-off, 33 patients were enrolled in Part A. Among the 27 response-evaluable patients, the ORR was 33%, with a disease control rate (DCR) of 93%, including nine partial responses and 16 stable disease responses. The median progression-free survival (PFS) was 6.3 months. In patients with left-sided tumors, the ORR was 38% and the DCR was 100%, with a median PFS of 8.6 months. The treatment regimen was well-tolerated, with most adverse events being of low grade.

Enrollment in Part B of the DeFianCe Study is ongoing and expected to be completed by the end of September 2024. This part of the study has been expanded from 130 to 180 patients, with progression-free survival in left-sided CRC patients included as an additional primary endpoint. As of August 9, 2024, 161 patients have enrolled in Part B.

The randomized controlled Part C of the DisTinGuish study, involving patients with GEJ and gastric cancer, is also progressing. This study evaluates DKN-01 in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy alone. Initial data is anticipated by late 2024 or early 2025.

Business Update:

Leap Therapeutics successfully raised $40 million through a private placement in April 2024, involving both new and existing investors, including Gilead Sciences, Inc. The funds, combined with existing cash and marketable securities, are expected to support the company's operations and capital expenditures into the second quarter of 2026.

Financial Highlights:

For the second quarter of 2024, Leap Therapeutics reported a net loss of $20.4 million, up from $13.4 million in the same period in 2023. The increase was mainly due to higher research and development costs, which rose to $17.9 million from $11.1 million in the previous year, driven by clinical trial expenses, patient enrollment, and related activities. General and administrative expenses slightly decreased to $3.4 million from $3.6 million. As of June 30, 2024, the company had $78.5 million in cash and cash equivalents.

Leap Therapeutics continues to advance its pipeline, focusing on delivering new treatments for patients battling cancer.