On August 14, 2025 Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, reported financial results for the second quarter of 2025 (Press release, Leap Therapeutics, AUG 14, 2025, View Source [SID1234655306]).
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Leap Highlights:
· Board of Directors initiated process of exploring strategic alternatives to maximize shareholder value
· Strategic restructuring to prioritize corporate development resulting in a further 75% reduction in workforce
· Reported updated data from the randomized, controlled Part B of the Phase 2 DeFianCe study of sirexatamab (DKN-01) plus bevacizumab and chemotherapy in second-line colorectal cancer (CRC)
"This past quarter, we undertook a strategic realignment to focus our resources on corporate development opportunities for sirexatamab and FL-501," said Douglas E. Onsi, President and CEO of Leap Therapeutics. "As part of this effort, we completed patient treatment in the DeFianCe trial, further reduced internal expenses, and initiated a review of strategic alternatives to maximize value for our shareholders. We intend to provide a further update in the coming weeks. We are grateful to all of our team members, and we thank them for their important contributions to Leap and their commitment to developing new therapies for cancer patients."
DKN-01 Development Update
· Reported updated clinical data from Part B of the DeFianCe study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. In the updated analysis as of May 22, 2025, sirexatamab demonstrated a statistically significant benefit on overall response rate (ORR), by investigator assessment and blinded independent central review, and progression-free survival (PFS) in patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis, along with a positive trend on ORR and PFS in the full intent-to-treat population. The final data from the study is being prepared for presentation at a future medical conference.
Business Updates
· Exploring strategic alternatives to preserve and maximize shareholder value. The Board of Directors initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Company’s Board of Directors has approved the engagement of Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist in the strategic evaluation process.
· Taking additional steps to reduce spending and preserve capital. The Company implemented an additional workforce reduction of approximately 75%. The total costs related to this reduction in force, including severance payments, are estimated to be approximately $4.5 million. The majority of these costs will be recognized in the third and fourth quarters of 2025.
Selected Second Quarter 2025 Financial Results
Net Loss was $16.6 million for the second quarter 2025, compared to $20.4 million for the second quarter 2024. The decrease was primarily due to a decrease in research and development and general and administrative expenses, offset in part by a restructuring charge associated with the reduction in force.
Research and development expenses were $10.5 million for the second quarter of 2025, compared to $17.9 million for the same period in 2024. The decrease of $7.4 million was primarily due to decreases of $3.9 million in clinical trial costs, $1.7 million in payroll and other headcount related expenses, $1.4 million in manufacturing costs, and $0.4 million in stock-based compensation expense.
General and administrative expenses were $1.8 million for the second quarter 2025, compared to $3.4 million for the same period in 2024. The decrease of $1.6 million was primarily due to decreases of $1.4 million in payroll and other incentive based compensation expense and a $0.2 million decrease in stock-based compensation expense.
During the second quarter of 2025, we incurred $4.5 million of restructuring charges associated with our workforce reduction, consisting primarily of one-time employee severance and benefit costs.
Cash and cash equivalents totaled $18.1 million on June 30, 2025.