Leap Therapeutics(LPTX) - 2025 Q2 - Quarterly Results

Company Overview and Strategic Highlights Leap Therapeutics strategically realigned in Q2 2025, focusing resources on key development opportunities and initiating a strategic alternatives review to maximize shareholder value CEO Statement and Strategic Realignment Leap Therapeutics strategically realigned in Q2 2025, focusing resources on sirexatamab and FL-501, completed DeFianCe trial patient treatment, cut internal expenses, and initiated a strategic alternatives review to maximize shareholder value - Company strategically realigned, concentrating resources on sirexatamab and FL-501 corporate development opportunities[3] - Completed patient treatment for the DeFianCe trial[3] - Initiated a review of strategic alternatives to maximize shareholder value[3] DKN-01 Development Update Sirexatamab in DeFianCe Part B showed statistically significant benefits in ORR and PFS for specific CRC patient groups, with positive trends in the ITT population, and final data is being prepared for future medical conferences - Sirexatamab in DeFianCe Part B demonstrated statistically significant benefits in ORR and PFS for CRC patients with high DKK1, no prior anti-VEGF treatment, or liver metastases[4] - Positive trends in ORR and PFS observed in the full intent-to-treat population[4] - Final data from the DeFianCe study is being prepared for submission to future medical conferences[4] Business Updates The company is exploring strategic alternatives to enhance shareholder value and has implemented significant workforce reductions to preserve capital Strategic Alternatives Exploration The Board initiated a process to explore strategic alternatives to preserve and maximize shareholder value, including leveraging cash balances and exploring potential sale or partnership opportunities for sirexatamab and FL-501, engaging Raymond James & Associates, Inc. as exclusive financial advisor - Board initiated exploration of strategic alternatives to preserve and maximize shareholder value, including potential sale or partnership of sirexatamab and FL-501[7][8] - Raymond James & Associates, Inc. engaged as exclusive financial advisor to assist with the strategic evaluation process[8] Workforce Reduction and Capital Preservation The company implemented an additional workforce reduction of approximately 75% to further cut expenses and preserve capital, with total associated costs estimated at $4.5 million, mostly recognized in Q3 and Q4 2025 - Company implemented approximately 75% additional workforce reduction to cut expenses and preserve capital[7][8] - Total cost of workforce reduction estimated at $4.5 million, primarily recognized in Q3 and Q4 2025[8] Selected Second Quarter 2025 Financial Results A summary of Leap Therapeutics' financial performance for Q2 2025, highlighting net loss, operating expenses, and cash position Net Loss Overview Leap Therapeutics reported a net loss of $16.6 million in Q2 2025, a decrease from $20.4 million in Q2 2024, primarily due to reduced R&D and G&A expenses, partially offset by restructuring charges Net Loss (Millions USD) | Metric | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Net Loss | $(16.6) | $(20.4) | - Net loss reduction primarily due to decreased research and development and general and administrative expenses, partially offset by restructuring charges[6] Operating Expenses Total operating expenses in Q2 2025 decreased compared to Q2 2024, driven by significant reductions in R&D and G&A expenses, despite the recognition of restructuring charges during the period Research and Development Expenses R&D expenses for Q2 2025 were $10.5 million, a $7.4 million decrease from $17.9 million in Q2 2024, mainly due to reduced clinical trial costs, personnel-related expenses, manufacturing costs, and stock-based compensation R&D Expenses (Millions USD) | Period | Q2 2025 | Q2 2024 | Change | | :----- | :------ | :------ | :----- | | R&D Expenses | $10.5 | $17.9 | $(7.4) | - R&D expenses decreased primarily due to a $3.9 million reduction in clinical trial costs, a $1.7 million reduction in salaries and personnel-related expenses, a $1.4 million reduction in manufacturing costs, and a $0.4 million reduction in stock-based compensation expenses[9] General and Administrative Expenses G&A expenses for Q2 2025 were $1.8 million, a $1.6 million decrease from $3.4 million in Q2 2024, mainly due to reduced salaries, other incentive compensation, and stock-based compensation expenses G&A Expenses (Millions USD) | Period | Q2 2025 | Q2 2024 | Change | | :----- | :------ | :------ | :----- | | G&A Expenses | $1.8 | $3.4 | $(1.6) | - G&A expenses decreased primarily due to a $1.4 million reduction in salaries and other incentive compensation expenses and a $0.2 million reduction in stock-based compensation expenses[10] Restructuring Charges The company incurred $4.5 million in restructuring charges in Q2 2025 due to workforce reductions, primarily comprising one-time employee severance and benefit costs Restructuring Charges (Millions USD) | Period | Q2 2025 | Q2 2024 | | :----- | :------ | :------ | | Restructuring Charges | $4.5 | $0.0 | - Restructuring charges primarily include one-time employee severance and benefit costs related to workforce reductions[11] Cash and Cash Equivalents As of June 30, 2025, the company's cash and cash equivalents totaled $18.1 million Cash and Cash Equivalents (Millions USD) | As of Date | Amount | | :--------- | :----- | | June 30, 2025 | $18.1 | About Leap Therapeutics Leap Therapeutics is a biotechnology company focused on developing targeted and immuno-oncology therapeutics, with a pipeline including sirexatamab (DKN-01) and FL-501 Company Profile and Pipeline Leap Therapeutics is a biotechnology company focused on developing targeted and immuno-oncology therapeutics, with a pipeline including sirexatamab (DKN-01) targeting DKK1 protein and FL-501 targeting GDF-15 protein - Leap Therapeutics is a biotechnology company focused on developing targeted and immuno-oncology therapeutics[13] - Product pipeline includes sirexatamab (DKN-01) targeting DKK1 protein and FL-501 targeting GDF-15 protein[13] Forward-Looking Statements This section outlines the inherent risks and uncertainties associated with forward-looking statements, which may cause actual results to differ materially from projections Disclaimer and Risk Factors This press release contains forward-looking statements based on management's current plans, estimates, and expectations, subject to various risks and uncertainties that could cause actual results to differ materially; key risks include the ability to sell or partner sirexatamab or FL-501, costs and timelines for DeFianCe study completion and operational termination, regulatory feedback, and availability of strategic alternatives - Forward-looking statements are based on current plans, estimates, and expectations, but are subject to various risks and uncertainties that could cause actual results to differ materially[14] - Key risk factors include the company's ability to successfully sell or partner sirexatamab or FL-501, the costs and timelines for completing the DeFianCe study and terminating operations, regulatory feedback, and the availability of strategic alternatives that can preserve or generate shareholder value[15] Contact Information Provides essential contact details for investor and media inquiries regarding Leap Therapeutics Investor and Media Contacts Contact information is provided for Douglas E. Onsi, President and CEO of Leap Therapeutics, and Investor Relations (via Argot Partners) - Contact information provided for Douglas E. Onsi, President and CEO of Leap Therapeutics, and Investor Relations (Argot Partners)[16][17] Condensed Consolidated Financial Statements Presents the company's condensed consolidated financial statements, including statements of operations, balance sheets, and cash flows for the specified periods Condensed Consolidated Statements of Operations This statement details operating expenses, operating loss, other income/expenses, and net loss for the three and six months ended June 30, 2025 and 2024, highlighting significant reductions in R&D and G&A expenses, and restructuring charges in 2025 Condensed Consolidated Statements of Operations (in thousands USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $10,537 | $17,885 | $23,448 | $29,184 | | General and administrative | $1,817 | $3,367 | $4,823 | $6,893 | | Restructuring charges | $4,527 | $- | $4,527 | $- | | Total operating expenses | $16,881 | $21,252 | $32,798 | $36,077 | | Net loss | $(16,643) | $(20,128) | $(32,078) | $(33,948) | | Net loss per share (Basic & diluted) | $(0.40) | $(0.52) | $(0.78) | $(1.01) | Consolidated Balance Sheets This balance sheet provides a snapshot of assets, liabilities, and stockholders' equity as of June 30, 2025, and December 31, 2024, noting significant reductions in cash and cash equivalents, total assets, and stockholders' equity Consolidated Balance Sheets (in thousands USD) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $18,130 | $47,249 | | Total current assets | $19,161 | $48,039 | | Total assets | $20,042 | $49,124 | | Total current liabilities | $14,325 | $14,076 | | Total stockholders' equity | $5,717 | $35,048 | Condensed Consolidated Statements of Cash Flows The cash flow statement shows cash used in operating activities, cash provided by (used in) financing activities, and the effect of exchange rate changes on cash and cash equivalents for the three and six months ended June 30, 2025 and 2024, resulting in a net decrease in cash and cash equivalents for both periods in 2025 Condensed Consolidated Statements of Cash Flows (in thousands USD) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Cash used in operating activities | $(14,486) | $(13,671) | $(28,966) | $(29,187) | | Cash provided by (used in) financing activities | $(119) | $37,117 | $(180) | $37,146 | | Net increase (decrease) in cash and cash equivalents | $(14,583) | $23,558 | $(29,119) | $7,836 | | Cash and cash equivalents at end of period | $18,130 | $78,479 | $18,130 | $78,479 |