Core Insights - Leap Therapeutics announced a private investment in public equity (PIPE) offering amounting to $58,888,888, led by Winklevoss Capital, to initiate a digital asset treasury strategy [1][2] - The offering includes the purchase of 95,849,353 shares of common stock and warrants for an additional 71,887,008 shares at an exercise price of $0.5335 per share [1][2] - The company plans to utilize part of the capital for the development of its therapeutic programs, including FL-501 and sirexatamab, which recently completed a Phase 2 trial for colorectal cancer [2] Financial Details - The aggregate exercise price per Unit in the PIPE offering is set at $0.61439 [1] - The closing of the private placement is expected around October 8, 2025, pending customary closing conditions [3] Strategic Developments - Winklevoss Capital will provide both capital and strategic support, and will have the right to nominate two members to Leap's Board of Directors, including a chairperson [2][3] - Leap has selected Parcrest as the placement agent, with Morgan, Lewis & Bockius LLP and Cooley LLP serving as legal advisors [4] Regulatory Compliance - The securities are being offered in a private placement under exemptions from the registration requirements of the Securities Act of 1933 [5] - A registration rights agreement has been established to allow for the resale of the purchased shares [5]

Core Insights - Leap Therapeutics, Inc. announced the presentation of final clinical results from Part B of the DeFianCe study, focusing on the efficacy of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy for advanced microsatellite stable colorectal cancer [1][2] Company Overview - Leap Therapeutics is a biotechnology company specializing in targeted and immuno-oncology therapeutics, with a pipeline that includes sirexatamab (DKN-01) and FL-501, both humanized monoclonal antibodies targeting specific proteins [2] Clinical Study Details - The DeFianCe study is a Phase 2 trial comparing the Sirexatamab Arm (sirexatamab plus bevacizumab and chemotherapy) to the Control Arm (bevacizumab and chemotherapy) in patients who have received one prior systemic therapy for advanced disease [1][2] - The final results will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, scheduled for October 17-21 in Berlin, Germany [1]

[Company Overview and Strategic Highlights](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Highlights) 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](index=1&type=section&id=CEO%20Statement%20and%20Strategic%20Realignment) 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](index=3&type=chunk) - Completed patient treatment for the **DeFianCe trial**[3](index=3&type=chunk) - Initiated a review of strategic alternatives to maximize shareholder value[3](index=3&type=chunk) [DKN-01 Development Update](index=1&type=section&id=DKN-01%20Development%20Update) 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](index=4&type=chunk) - Positive trends in **ORR and PFS** observed in the full intent-to-treat population[4](index=4&type=chunk) - Final data from the DeFianCe study is being prepared for submission to future medical conferences[4](index=4&type=chunk) [Business Updates](index=1&type=section&id=Business%20Updates) The company is exploring strategic alternatives to enhance shareholder value and has implemented significant workforce reductions to preserve capital [Strategic Alternatives Exploration](index=1&type=section&id=Strategic%20Alternatives%20Exploration) 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](index=7&type=chunk)[8](index=8&type=chunk) - **Raymond James & Associates, Inc.** engaged as exclusive financial advisor to assist with the strategic evaluation process[8](index=8&type=chunk) [Workforce Reduction and Capital Preservation](index=1&type=section&id=Workforce%20Reduction%20and%20Capital%20Preservation) 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](index=7&type=chunk)[8](index=8&type=chunk) - Total cost of workforce reduction estimated at **$4.5 million**, primarily recognized in Q3 and Q4 2025[8](index=8&type=chunk) [Selected Second Quarter 2025 Financial Results](index=1&type=section&id=Selected%20Second%20Quarter%202025%20Financial%20Results) A summary of Leap Therapeutics' financial performance for Q2 2025, highlighting net loss, operating expenses, and cash position [Net Loss Overview](index=1&type=section&id=Net%20Loss%20Overview) 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](index=6&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) 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](index=2&type=section&id=Research%20and%20Development%20Expenses) 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](index=9&type=chunk) [General and Administrative Expenses](index=2&type=section&id=General%20and%20Administrative%20Expenses) 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](index=10&type=chunk) [Restructuring Charges](index=2&type=section&id=Restructuring%20Charges) 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](index=11&type=chunk) [Cash and Cash Equivalents](index=2&type=section&id=Cash%20and%20Cash%20Equivalents) 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](index=2&type=section&id=About%20Leap%20Therapeutics) 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](index=2&type=section&id=Company%20Profile%20and%20Pipeline) 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](index=13&type=chunk) - Product pipeline includes **sirexatamab (DKN-01)** targeting DKK1 protein and **FL-501** targeting GDF-15 protein[13](index=13&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) 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](index=2&type=section&id=Disclaimer%20and%20Risk%20Factors) 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](index=14&type=chunk) - 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](index=15&type=chunk) [Contact Information](index=2&type=section&id=Contact%20Information) Provides essential contact details for investor and media inquiries regarding Leap Therapeutics [Investor and Media Contacts](index=2&type=section&id=Investor%20and%20Media%20Contacts) 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](index=16&type=chunk)[17](index=17&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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 |

Core Insights - Leap Therapeutics, Inc. reported a strategic realignment focusing on corporate development opportunities for its products sirexatamab and FL-501, alongside a reduction in internal expenses and a review of strategic alternatives to maximize shareholder value [2][11]. Financial Performance - The net loss for the second quarter of 2025 was $16.6 million, a decrease from $20.4 million in the same quarter of 2024, primarily due to reduced research and development and general administrative expenses [5][6]. - Research and development expenses were $10.5 million for Q2 2025, down from $17.9 million in Q2 2024, reflecting a decrease of $7.4 million attributed to lower clinical trial costs and other related expenses [6]. - General and administrative expenses decreased to $1.8 million in Q2 2025 from $3.4 million in Q2 2024, mainly due to reductions in payroll and incentive-based compensation [7]. - The company incurred $4.5 million in restructuring charges related to workforce reduction during the second quarter [8]. Clinical Development - Updated clinical data from the DeFianCe study indicated that sirexatamab showed a statistically significant benefit in overall response rate and progression-free survival in colorectal cancer patients with specific characteristics [3]. Strategic Initiatives - The Board of Directors initiated a process to explore strategic alternatives, including potential sales or partnerships for sirexatamab and FL-501, and engaged Raymond James & Associates, Inc. as an exclusive financial advisor [11]. - The company implemented a workforce reduction of approximately 75% to further reduce spending and preserve capital [11]. Cash Position - As of June 30, 2025, cash and cash equivalents totaled $18.1 million, a decrease from $47.2 million at the end of 2024 [15].

PART I — FINANCIAL INFORMATION This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the company's financial performance [Item 1. Financial Statements](index=6&type=section&id=Item%201%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Leap Therapeutics, Inc., including balance sheets, statements of operations, comprehensive loss, stockholders' equity, and cash flows, along with detailed notes explaining the company's business, accounting policies, and financial position as of June 30, 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific reporting dates Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | 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 | - Cash and cash equivalents decreased significantly from **$47.2 million** at December 31, 2024, to **$18.1 million** at June 30, 2025[19](index=19&type=chunk) - Total stockholders' equity declined from **$35.0 million** to **$5.7 million** over the same period[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This section details the company's operational performance, including revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations (in thousands) | Metric (in thousands) | 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 | $0 | $4,527 | $0 | | 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 and diluted) | $(0.40) | $(0.52) | $(0.78) | $(1.01) | - Research and development expenses decreased by **$7.3 million (41%)** for the three months ended June 30, 2025, compared to the same period in 2024, and by **$5.7 million (20%)** for the six months[22](index=22&type=chunk) - The company incurred **$4.5 million** in restructuring charges during the three and six months ended June 30, 2025, related to a workforce reduction[22](index=22&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section details the company's comprehensive loss, including net loss and other comprehensive income/loss items Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(16,643) | $(20,128) | $(32,078) | $(33,948) | | Foreign currency translation adjustments | $31 | $123 | $38 | $(103) | | Comprehensive loss | $(16,612) | $(20,005) | $(32,040) | $(34,051) | [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in stockholders' equity, including common stock, additional paid-in capital, and accumulated deficit Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Metric (in thousands) | Balances at Dec 31, 2024 | Balances at June 30, 2025 | | :-------------------- | :----------------------- | :------------------------ | | Common Stock Shares | 38,329,894 | 41,439,529 | | Common Stock Amount | $38 | $41 | | Additional Paid-in Capital | $502,501 | $505,207 | | Accumulated Deficit | $(467,371) | $(499,449) | | Total Stockholders' Equity | $35,048 | $5,717 | - Total stockholders' equity decreased from **$35.0 million** at December 31, 2024, to **$5.7 million** at June 30, 2025, primarily due to a net loss of **$32.1 million**[32](index=32&type=chunk) - Common stock shares outstanding increased from **38,329,894** to **41,439,529**, mainly due to the exercise of prefunded warrants and vesting of restricted stock units[32](index=32&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(28,966) | $(29,187) | | Net cash provided by (used in) financing activities | $(180) | $37,146 | | Net increase (decrease) in cash and cash equivalents | $(29,119) | $7,836 | | Cash and cash equivalents at end of period | $18,130 | $78,479 | - Net cash used in operating activities remained consistent year-over-year, at approximately **$29 million** for both periods[35](index=35&type=chunk) - Financing activities shifted from providing **$37.1 million** in 2024 (due to a private placement) to using **$0.18 million** in 2025[35](index=35&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1. Nature of Business, Basis of Presentation and Liquidity](index=12&type=section&id=1.%20Nature%20of%20Business,%20Basis%20of%20Presentation%20and%20Liquidity) This note describes the company's business, basis of financial statement presentation, and assessment of its liquidity and going concern status - Leap Therapeutics, Inc. is a biopharmaceutical company focused on developing novel biomarker-targeted antibody therapies for cancer, with lead clinical program sirexatamab (DKN-01) and preclinical program FL-501[43](index=43&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk) - As of June 30, 2025, the company had cash and cash equivalents of **$18.1 million** and an accumulated deficit of **$499.4 million**, leading to substantial doubt about its ability to continue as a going concern for at least the next 12 months[47](index=47&type=chunk)[149](index=149&type=chunk) - The company is exploring strategic alternatives, including mergers, asset sales, license agreements, or additional financing, to preserve and maximize shareholder value. Failure to complete a transaction could lead to business discontinuation and liquidation[48](index=48&type=chunk)[150](index=150&type=chunk) [Note 2. Summary of Significant Accounting Policies](index=13&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting policies and estimates used in preparing the financial statements - The company recognizes Australian research and development incentives as other income, with a refundable tax offset of **43.5%** of eligible R&D expenses[51](index=51&type=chunk)[53](index=53&type=chunk) Research and Development Incentive Receivable (in thousands) | Date | Amount | | :-------------------- | :----- | | Balance at January 1, 2024 | $771 | | Balance at December 31, 2024 | $704 | | Balance at June 30, 2025 | $798 | - The company recorded **$4.5 million** in restructuring charges during Q2 2025 due to a **75%** workforce reduction, primarily for severance and stock-based compensation[58](index=58&type=chunk)[134](index=134&type=chunk) - The One Big Beautiful Bill Act (OBBBA) was signed into law on July 4, 2025, and its effects on income taxes will be recognized in Q3 2025[70](index=70&type=chunk) [Note 3. Accrued Expenses](index=17&type=section&id=3.%20Accrued%20Expenses) This note details the composition of accrued expenses, including clinical trials, professional fees, and payroll Accrued Expenses (in thousands) | Category | June 30, 2025 | December 31, 2024 | | :------------------ | :------------ | :---------------- | | Clinical trials | $2,600 | $4,798 | | Professional fees | $369 | $274 | | Payroll and related expenses | $114 | $3,464 | | Severance | $3,540 | $0 | | Total accrued expenses | $6,623 | $8,536 | - Accrued severance increased significantly to **$3.54 million** as of June 30, 2025, reflecting the recent workforce reduction[75](index=75&type=chunk) [Note 4. Leases](index=17&type=section&id=4.%20Leases) This note provides information on the company's operating lease arrangements and related expenses - The company has an operating lease for real estate, with a right-of-use asset of **$38 thousand** and a lease liability of **$39 thousand** as of June 30, 2025[78](index=78&type=chunk) - Rent expense for the six months ended June 30, 2025, was **$235 thousand**, slightly up from **$225 thousand** in the prior year[78](index=78&type=chunk) [Note 5. Warrants](index=18&type=section&id=5.%20Warrants) This note describes the company's outstanding warrants, their terms, and exercise activity Outstanding Warrants as of June 30, 2025 | Description | Number of Common Shares Issuable | Exercise Price | Expiration Date | | :---------------------- | :------------------------------- | :------------- | :---------------- | | January 23 2017 Warrants | 5,450 | $0.10 | Upon M&A Event | | 2019 Warrants | 690,813 | $19.50 | February 2026 | | March 2020 Coverage Warrants | 2,594,503 | $21.10 | Jan - March 2027 | | Total | 3,290,766 | | | - During the six months ended June 30, 2025, a total of **2,939,765** pre-funded warrants (March 2020, September 2021, April 2024) were cashless exercised, resulting in the issuance of **2,921,041** common shares[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) [Note 6. Common Stock](index=19&type=section&id=6.%20Common%20Stock) This note provides details on the company's common stock, including shares outstanding and recent equity issuances - As of June 30, 2025, **41,439,529** shares of common stock were outstanding. No dividends have been declared for common stock through this period[4](index=4&type=chunk)[87](index=87&type=chunk) - In April 2024, the company completed a private placement, issuing **12,660,993** common shares and **1,523,404** prefunded warrants, generating **$37.05 million** in net proceeds[88](index=88&type=chunk) [Note 7. Equity Incentive Plans](index=19&type=section&id=7.%20Equity%20Incentive%20Plans) This note outlines the company's equity incentive plans, stock option activity, and stock-based compensation expense - As of June 30, 2025, there were **3,922,812** shares available for grant under the company's equity incentive plans[91](index=91&type=chunk) Stock Option Activity | Metric | Outstanding at Dec 31, 2024 | Outstanding at June 30, 2025 | | :---------------------- | :-------------------------- | :--------------------------- | | Options | 6,416,744 | 5,031,973 | | Weighted Average Exercise Price | $8.43 | $8.68 | Stock Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :---------------------- | :------------------------------- | :----------------------------- | | Research and development | $387 | $1,021 | | General and administrative | $476 | $1,046 | | Restructuring charges | $626 | $626 | | Total | $1,489 | $2,693 | [Note 8. Net Loss Per Share](index=21&type=section&id=8.%20Net%20Loss%20Per%20Share) This note details the calculation of basic and diluted net loss per share attributable to common stockholders Net Loss Per Share Attributable to Common Stockholders (in thousands) | 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 | | :---------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss attributable to common stockholders | $(16,643) | $(20,362) | $(32,078) | $(34,182) | | Weighted average common shares outstanding | 41,444,979 | 39,122,662 | 41,357,423 | 33,830,083 | | Net loss per share (Basic and diluted) | $(0.40) | $(0.52) | $(0.78) | $(1.01) | - Potentially dilutive securities (RSUs, stock options, and warrants) were excluded from diluted EPS calculations due to their anti-dilutive effect, given the net loss[101](index=101&type=chunk) [Note 9. Commitments and Contingencies](index=21&type=section&id=9.%20Commitments%20and%20Contingencies) This note discloses the company's contractual commitments, insurance agreements, and potential future obligations - The company has **$12 thousand** in noncancelable commitments under manufacturing agreements for DKN-01[102](index=102&type=chunk) - An insurance premium financing agreement was entered in March 2025 for **$440 thousand** at an **8.74%** fixed annual interest rate, with an outstanding principal of **$245 thousand** as of June 30, 2025[103](index=103&type=chunk) - The company has license and collaboration agreements that may require future royalty and milestone payments upon product commercialization, but no such payments have been made or accrued through June 30, 2025[104](index=104&type=chunk)[105](index=105&type=chunk) [Note 10. Subsequent Events](index=22&type=section&id=10.%20Subsequent%20Events) This note reports on significant events that occurred after the balance sheet date but before the financial statements were issued - On July 1, 2025, the company amended its 47 Thorndike Street Lease, extending it as a tenancy-at-will until at least August 31, 2025, and reducing the premises size, with annual fixed rent of **$230 thousand** (**$19 thousand** per month) from August 1, 2025[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on the company's financial condition and operational results, highlighting recent developments, financial performance comparisons for the three and six months ended June 30, 2025 and 2024, and a discussion of liquidity and capital resources, including the ongoing going concern issue and strategic alternatives [Company Overview](index=23&type=section&id=Company%20Overview) This section discusses company overview - Leap Therapeutics is a biopharmaceutical company developing biomarker-targeted antibody therapies for cancer, with lead clinical program sirexatamab (DKN-01) and preclinical program FL-501[111](index=111&type=chunk)[112](index=112&type=chunk) - The company has not yet generated product sales revenue and has funded operations primarily through common and preferred stock sales and notes payable[113](index=113&type=chunk) [Recent Developments](index=23&type=section&id=Recent%20Developments) This section discusses recent developments - Updated clinical data from the DeFianCe study of sirexatamab showed **statistically significant benefits** in ORR and PFS for CRC patients with high DKK1 levels, no prior anti-VEGF therapy, or liver metastasis[115](index=115&type=chunk) - The Board of Directors initiated a process to explore strategic alternatives to maximize shareholder value, including potential sale or partnership opportunities for sirexatamab and FL-501[116](index=116&type=chunk) - The company implemented an additional workforce reduction of approximately **75%** to reduce spending and preserve capital, incurring estimated costs of **$4.5 million**[116](index=116&type=chunk) [Financial Overview](index=24&type=section&id=Financial%20Overview) This section discusses financial overview Research and Development Expenses by Program (in thousands) | Program | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | DKN-01 program | $9,999 | $17,806 | $22,786 | $28,989 | | FL-501 program | $538 | $45 | $662 | $103 | | Total R&D expenses | $10,537 | $17,885 | $23,448 | $29,184 | | Australian R&D incentives | $1 | $253 | $56 | $499 | - DKN-01 program expenses decreased by **$7.8 million (44%)** for the three months and **$6.2 million (21%)** for the six months ended June 30, 2025, compared to the prior year[120](index=120&type=chunk) - Australian R&D incentive income significantly decreased from **$253 thousand** to **$1 thousand** for the three months, and from **$499 thousand** to **$56 thousand** for the six months ended June 30, 2025[120](index=120&type=chunk) [Critical Accounting Policies and Estimates](index=25&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses critical accounting policies and estimates - Key accounting policies involving significant judgment and complexity include accrued research and development expenses, research and development incentive receivable, and stock-based compensation[130](index=130&type=chunk) [Results of Operations](index=26&type=section&id=Results%20of%20Operations) This section discusses results of operations Operating Expenses Comparison (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change (Decrease) | | :-------------------- | :--------------------------- | :--------------------------- | :---------------- | | Research and development | $10,537 | $17,885 | $(7,348) | | General and administrative | $1,817 | $3,367 | $(1,150) | | Restructuring charges | $4,527 | $0 | $4,527 | | Total operating expenses | $16,881 | $21,252 | $(4,371) | - The decrease in R&D expenses for Q2 2025 was primarily due to a **$3.9 million** decrease in clinical trial costs, **$1.7 million** in payroll, **$1.4 million** in manufacturing, and **$0.4 million** in stock-based compensation[132](index=132&type=chunk) - General and administrative expenses decreased by **$1.6 million** in Q2 2025, mainly due to a **$1.4 million** decrease in payroll and incentive-based compensation[133](index=133&type=chunk) Six Months Operating Expenses Comparison (in thousands) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change (Decrease) | | :-------------------- | :--------------------------- | :--------------------------- | :---------------- | | Research and development | $23,448 | $29,184 | $(5,736) | | General and administrative | $4,823 | $6,893 | $(2,070) | | Restructuring charges | $4,527 | $0 | $4,527 | | Total operating expenses | $32,798 | $36,077 | $(3,279) | - Interest income decreased from **$0.9 million** to **$0.2 million** for the three months and from **$1.6 million** to **$0.7 million** for the six months ended June 30, 2025, due to a lower average cash balance[135](index=135&type=chunk)[144](index=144&type=chunk) [Financial Position, Liquidity and Capital Resources](index=29&type=section&id=Financial%20Position,%20Liquidity%20and%20Capital%20Resources) This section discusses financial position, liquidity and capital resources - The company has not achieved profitable operations or positive cash flows from operations since inception and expects to continue generating operating losses[148](index=148&type=chunk)[149](index=149&type=chunk) - As of June 30, 2025, cash and cash equivalents were **$18.1 million**, and an accumulated deficit of **$499.4 million** raises substantial doubt about the company's ability to continue as a going concern[149](index=149&type=chunk) - Net cash used in operating activities was **$29.0 million** for the six months ended June 30, 2025, consistent with **$29.2 million** in the prior year[151](index=151&type=chunk)[152](index=152&type=chunk) - Net cash used in financing activities was **$0.18 million** for the six months ended June 30, 2025, a significant change from **$37.1 million** provided in the prior year due to the absence of a private placement[151](index=151&type=chunk)[155](index=155&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period - The company has no applicable quantitative and qualitative disclosures about market risk[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204%20Controls%20and%20Procedures) This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting - As of June 30, 2025, management concluded that the company's disclosure controls and procedures were **effective**[158](index=158&type=chunk) - There were no material changes in internal control over financial reporting during the three months ended June 30, 2025[159](index=159&type=chunk) PART II — OTHER INFORMATION This section covers other required disclosures, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=31&type=section&id=Item%201%20Legal%20Proceedings) This section states that the company is not currently a party to any material legal proceedings - The company is not currently involved in any material legal proceedings[161](index=161&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A%20Risk%20Factors) This section highlights significant risks, particularly the substantial doubt about the company's ability to continue as a going concern due to the need for additional capital and uncertainties in securing funding or completing strategic transactions - Management concluded that substantial doubt exists about the company's ability to continue as a going concern due to the need for additional capital and uncertainties in raising such funding[163](index=163&type=chunk) - Failure to successfully complete a strategic transaction (merger, asset sale, license, or financing) could materially adversely affect the business and force discontinuation of operations[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=31&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section indicates that there were no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities to report - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities were reported[165](index=165&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities - No defaults upon senior securities were reported[166](index=166&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This section indicates that there are no mine safety disclosures applicable to the company - No mine safety disclosures were reported[167](index=167&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205%20Other%20Information) This section reports on other information, specifically regarding Rule 10b5-1 trading plans - No director or officer adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[168](index=168&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206%20Exhibits) This section lists all exhibits filed or furnished with the Quarterly Report on Form 10-Q, including lease amendments, certifications, and XBRL data - Exhibits include a Fifth Amendment to Lease, CEO/CFO certifications (Rule 13a-14(a) and 18 U.S.C. Section 1350), and XBRL formatted financial statements[171](index=171&type=chunk)

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].

Financial Performance - Leap Therapeutics reported a net loss of $15.4 million for Q1 2025, an increase from $13.8 million in Q1 2024, primarily due to higher research and development expenses [10]. - Leap's total operating expenses for Q1 2025 were $15.9 million, compared to $14.8 million in Q1 2024 [20]. - Leap's accumulated deficit increased to $482.8 million as of March 31, 2025, compared to $467.4 million at the end of 2024 [22]. Research and Development - Research and development expenses rose to $12.9 million in Q1 2025, up from $11.3 million in the same period of 2024, driven by increased clinical trial costs [11]. - The company announced a strategic restructuring, resulting in an approximately 50% reduction in workforce to focus on the clinical development of sirexatamab and FL-501 [6]. - The company plans to advance sirexatamab into a registrational Phase 3 clinical trial, indicating a significant potential market opportunity [13]. Clinical Trial Results - Sirexatamab demonstrated a statistically significant 32% higher overall response rate (ORR) and 3.5 months longer progression-free survival (PFS) in patients with high DKK1 levels compared to the control arm [7]. - In patients who had not received prior anti-VEGF therapy, the Sirexatamab arm showed a statistically significant 22% higher ORR and 2.6 months longer PFS compared to the control arm [7]. - Leap hosted a virtual key opinion leader event to discuss the positive data from the DeFianCe study, highlighting the unmet need in advanced MSS CRC patients [13]. Cash and Cash Equivalents - The company has approximately $32.7 million in cash and cash equivalents as of March 31, 2025, down from $47.2 million at the end of 2024 [14]. - Cash and cash equivalents at the end of Q1 2025 were $32,713 thousand, down from $54,921 thousand at the end of Q1 2024, representing a decrease of 40.4% [24]. - Cash used in operating activities decreased to $(14,480) thousand in Q1 2025 from $(15,516) thousand in Q1 2024, showing an improvement of 6.7% [24]. - Net decrease in cash and cash equivalents for Q1 2025 was $(14,536) thousand compared to $(15,722) thousand in Q1 2024, indicating a 7.5% improvement [24]. - Cash provided by (used in) financing activities shifted from $29 thousand in Q1 2024 to $(61) thousand in Q1 2025, reflecting a change of 310.3% [24]. - The effect of exchange rate changes on cash and cash equivalents improved to $5 thousand in Q1 2025 from $(235) thousand in Q1 2024, marking a significant recovery [24]. - Cash and cash equivalents at the beginning of Q1 2025 were $47,249 thousand, down from $70,643 thousand at the beginning of Q1 2024, a decrease of 33.2% [24].

Core Insights - Leap Therapeutics reported financial results for Q1 2025, highlighting the progress of its lead candidate, sirexatamab, in clinical trials for colorectal cancer (CRC) [1][3] Financial Performance - The net loss for Q1 2025 was $15.4 million, an increase from $13.8 million in Q1 2024, primarily due to higher research and development expenses [8] - Research and development expenses rose to $12.9 million in Q1 2025 from $11.3 million in the same period in 2024, driven by increased clinical trial costs [9] - General and administrative expenses decreased to $3.0 million in Q1 2025 from $3.5 million in Q1 2024 [10] - Cash and cash equivalents totaled $32.7 million as of March 31, 2025, down from $47.2 million at the end of 2024 [10] Clinical Development Updates - Sirexatamab demonstrated statistically significant higher overall response rates (ORR) and longer progression-free survival (PFS) in DKK1-high and VEGF-naïve second-line CRC patients [3][6] - In the DeFianCe study, the Sirexatamab arm showed a 32% higher ORR and 3.5 months longer PFS in patients with high DKK1 levels compared to the control arm [7] - The company is advancing FL-501, a novel GDF-15 neutralizing antibody, in preclinical development, with promising preclinical data presented at the AACR 2025 Annual Meeting [6][7] Strategic Initiatives - Leap Therapeutics announced a strategic restructuring to focus on the clinical development of sirexatamab and FL-501, resulting in a workforce reduction of approximately 50% [6][14] - The company engaged a financial advisor to explore business development opportunities to further the development of sirexatamab, indicating a focus on expanding its market potential [14]

[FORM 10-Q Filing Information](index=1&type=section&id=FORM%2010-Q) This section provides essential identification details for the company's Quarterly Report on Form 10-Q [Registrant Information](index=1&type=section&id=Registrant%20Information) This section details Leap Therapeutics, Inc.'s identification for the Form 10-Q, covering its incorporation, address, trading symbol, and filing status - Registrant: **LEAP THERAPEUTICS, INC.**[2](index=2&type=chunk) - Filing Type: **Quarterly Report (10-Q)** for the period ended March 31, 2025[2](index=2&type=chunk) Trading Symbol and Exchange Information | Title of each class: | Trading Symbol(s) | Name of each exchange on which registered: | | :------------------ | :---------------- | :--------------------------------------- | | Common Stock, par value $0.001 per share | LPTX | Nasdaq Capital Market | - Filing Status: **Non-accelerated filer** and **Smaller reporting company**[5](index=5&type=chunk) - Outstanding Shares as of May 9, 2025: **41,439,529 shares** of common stock[5](index=5&type=chunk) [Table of Contents](index=2&type=section&id=TABLE%20OF%20CONTENTS) This section provides an organized list of all chapters and their corresponding page numbers within the report [Special Note Regarding Forward-Looking Statements and Industry Data](index=3&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS%20AND%20INDUSTRY%20DATA) This section provides important disclaimers regarding forward-looking statements and the use of industry data within the report [Forward-Looking Statements Disclaimer](index=3&type=section&id=Forward-Looking%20Statements%20Disclaimer) This section warns that the report contains forward-looking statements subject to risks and uncertainties, which are not guarantees of future performance - Forward-looking statements reflect current views on operations and financial performance, subject to risks and uncertainties[9](index=9&type=chunk) - Key factors that could cause actual results to differ include ability to develop and commercialize **sirexatamab (DKN-01)**, clinical trial status and results, regulatory approval, financial estimates, and market acceptance[9](index=9&type=chunk) - Readers are advised to refer to 'Risk Factors' in this and the Annual Report on Form 10-K for a discussion of important factors[12](index=12&type=chunk) - **Sirexatamab (DKN-01)** is an investigational drug, not yet approved by the FDA, and statements should not be deemed promotional[13](index=13&type=chunk) [Introductory Comment](index=5&type=section&id=INTRODUCTORY%20COMMENT) This section provides introductory remarks and clarifies terminology used throughout the report [References to Leap](index=5&type=section&id=References%20to%20Leap) This section clarifies that terms like 'Company' and 'we' refer to Leap Therapeutics, Inc. and its consolidated subsidiaries - References to 'Company,' 'Leap,' 'Leap Therapeutics,' 'we,' 'us,' and 'our' refer to **LEAP THERAPEUTICS, INC.** and its consolidated subsidiaries[16](index=16&type=chunk) [PART I — FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20%E2%80%94%20FINANCIAL%20INFORMATION) This section presents the company's unaudited condensed consolidated financial statements and related management discussion and analysis [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents Leap Therapeutics, Inc.'s unaudited condensed consolidated financial statements and related notes [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This section presents the company's financial position at specific dates, detailing assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheets (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :----------------------------------- | :------------- | :---------------- | | **Assets** | | | | Cash and cash equivalents | $32,713 | $47,249 | | Total current assets | $33,870 | $48,039 | | Total assets | $34,879 | $49,124 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $14,039 | $14,076 | | Total stockholders' equity | $20,840 | $35,048 | | Total liabilities and stockholders' equity | $34,879 | $49,124 | - Cash and cash equivalents decreased by **$14.5 million** from December 31, 2024, to March 31, 2025[19](index=19&type=chunk) - Total stockholders' equity decreased by **$14.2 million**, primarily due to the net loss incurred[19](index=19&type=chunk) [Condensed Consolidated Statements of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This section presents the company's financial performance over specific periods, detailing revenues, expenses, and net loss Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $12,911 | $11,299 | | General and administrative | $3,006 | $3,526 | | Total operating expenses | $15,917 | $14,825 | | Loss from operations | $(15,917) | $(14,825) | | Interest income | $437 | $775 | | Australian research and development incentives | $55 | $246 | | Net loss | $(15,435) | $(13,820) | | Net loss per share (Basic and diluted) | $(0.37) | $(0.51) | | Weighted average common shares outstanding | 41,268,894 | 27,014,100 | - Net loss increased by **$1.6 million** (**11.7%**) from **($13.8 million)** in Q1 2024 to **($15.4 million)** in Q1 2025[21](index=21&type=chunk) - Research and development expenses increased by **$1.6 million** (**14.3%**) YoY, while general and administrative expenses decreased by **$520 thousand** (**14.7%**) YoY[21](index=21&type=chunk) - Net loss per share improved from **($0.51)** to **($0.37)** despite a higher net loss, due to a significant increase in weighted average common shares outstanding[21](index=21&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=8&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20COMPREHENSIVE%20LOSS) This section presents the company's comprehensive loss, including net loss and other comprehensive income or loss items Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss | $(15,435) | $(13,820) | | Foreign currency translation adjustments | $7 | $(226) | | Comprehensive loss | $(15,428) | $(14,046) | - Comprehensive loss increased from **($14.0 million)** in Q1 2024 to **($15.4 million)** in Q1 2025[25](index=25&type=chunk) - Foreign currency translation adjustments shifted from a loss of **($226 thousand)** in Q1 2024 to a gain of **$7** thousand in Q1 2025[25](index=25&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=9&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20STOCKHOLDERS%27%20EQUITY) This section details changes in the company's stockholders' equity over specific periods, including stock issuance and net loss Condensed Consolidated Statements of Stockholders' Equity (in thousands, except share amounts) | Item | Balances at Dec 31, 2024 | Issuance of common stock upon exercise of stock options | Issuance of common stock upon exercise of prefunded warrants | Issuance of common stock upon vest of restricted stock units | Foreign currency translation adjustment | Stock-based compensation | Net loss | Balances at Mar 31, 2025 | | :----------------------------------- | :----------------------- | :-------------------------------------- | :----------------------------------------- | :------------------------------------------ | :-------------------------------------- | :----------------------- | :------- | :----------------------- | | Common Stock Shares | 38,329,894 | 6,667 | 2,921,041 | 181,927 | — | — | — | 41,439,529 | | Common Stock Amount | $38 | $0 | $3 | $0 | $0 | $0 | $0 | $41 | | Additional Paid-in Capital | $502,501 | $16 | $(3) | $0 | $0 | $1,204 | $0 | $503,718 | | Accumulated Other Comprehensive Income (Loss) | $(120) | $0 | $0 | $0 | $7 | $0 | $0 | $(113) | | Accumulated Deficit | $(467,371) | $0 | $0 | $0 | $0 | $0 | $(15,435) | $(482,806) | | Total Stockholders' Equity | $35,048 | $16 | $(3) | $0 | $7 | $1,204 | $(15,435) | $20,840 | - Total stockholders' equity decreased from **$35.0 million** at December 31, 2024, to **$20.8 million** at March 31, 2025, primarily due to the net loss of **($15.4 million)**[33](index=33&type=chunk) - Common stock shares outstanding increased by over **3 million shares**, mainly from the exercise of prefunded warrants (**2,921,041 shares**)[33](index=33&type=chunk) - **Stock-based compensation** contributed **$1.2 million** to additional paid-in capital during Q1 2025[33](index=33&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=11&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) This section presents the company's cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(14,480) | $(15,516) | | Net cash provided by (used in) financing activities | $(61) | $29 | | Effect of exchange rate changes on cash and cash equivalents | $5 | $(235) | | Net decrease in cash and cash equivalents | $(14,536) | $(15,722) | | Cash and cash equivalents at end of period | $32,713 | $54,921 | - Net cash used in operating activities decreased by **$1.0 million**, from **($15.5 million)** in Q1 2024 to **($14.5 million)** in Q1 2025[36](index=36&type=chunk) - Cash and cash equivalents at the end of the period decreased to **$32.7 million** in Q1 2025 from **$54.9 million** in Q1 2024[36](index=36&type=chunk) - Financing activities shifted from providing **$29 thousand** in Q1 2024 to using **($61 thousand)** in Q1 2025, primarily due to principal payments of insurance financing[36](index=36&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=12&type=section&id=NOTES%20TO%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS) This section provides detailed explanations and additional information supporting the condensed consolidated financial statements [1. Nature of Business, Basis of Presentation and Liquidity](index=12&type=section&id=1.%20Nature%20of%20Business%2C%20Basis%20of%20Presentation%20and%20Liquidity) This note describes Leap Therapeutics as a biopharmaceutical company, its financial statement basis, and highlights liquidity challenges raising going concern doubts - **Leap Therapeutics** is a **biopharmaceutical company** developing novel biomarker-targeted antibody therapies for cancer, with **sirexatamab (DKN-01)** as its lead clinical stage program for **colorectal cancer**[44](index=44&type=chunk) - The company has not yet generated product sales revenue or achieved profitable operations, and expects to continue generating operating losses[47](index=47&type=chunk)[48](index=48&type=chunk) - As of March 31, 2025, the company had cash and cash equivalents of **$32.7 million** and an accumulated deficit of **($482.8 million)**, raising substantial doubt about its ability to continue as a **going concern** for the next **12 months**[48](index=48&type=chunk) - Future operations are dependent on raising additional capital through equity financings, government programs, or collaboration agreements[49](index=49&type=chunk) [2. Summary of Significant Accounting Policies](index=14&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the significant accounting policies used in preparing the condensed consolidated financial statements, covering consolidation, estimates, R&D incentives, and fair value measurements - The company recognizes Australian research and development incentives as other income when there is reasonable assurance of receipt, based on eligible R&D expenses incurred by its Australian subsidiary[52](index=52&type=chunk)[53](index=53&type=chunk) - The R&D incentive percentage was **43.5%** for the three months ended March 31, 2025, and the receivable was **$766 thousand** as of March 31, 2025[54](index=54&type=chunk)[55](index=55&type=chunk) Research and Development Incentive Receivable (in thousands) | Item | Amount | | :----------------------------------- | :----- | | Balance at January 1, 2024 | $771 | | Foreign currency translation | $(67) | | Balance at December 31, 2024 | $704 | | Australian research and development incentive income | $55 | | Foreign currency translation | $7 | | Balance at March 31, 2025 | $766 | - Cash equivalents of **$13.0 million** (March 31, 2025) and **$23.3 million** (December 31, 2024) are classified as **Level 1 fair value assets**, consisting of overnight investments and money market funds[62](index=62&type=chunk) - The company accounts for **operating leases** by recognizing **right-of-use assets** and **lease liabilities**, electing to treat lease and non-lease components as a single lease component[65](index=65&type=chunk)[69](index=69&type=chunk) [3. Accrued Expenses](index=19&type=section&id=3.%20Accrued%20Expenses) This note details the composition of accrued expenses, primarily clinical trials, professional fees, and payroll-related costs Accrued Expenses (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Clinical trials | $4,694 | $4,798 | | Professional fees | $600 | $274 | | Payroll and related expenses | $1,698 | $3,464 | | Accrued expenses | $6,992 | $8,536 | - Total accrued expenses decreased by **$1.5 million** from December 31, 2024, to March 31, 2025, primarily due to a significant decrease in payroll and related expenses[75](index=75&type=chunk) [4. Leases](index=19&type=section&id=4.%20Leases) This note provides information on the company's operating lease for real estate, including its expiration and associated assets, liabilities, and expenses - The company has an **operating lease** for real estate in the United States, expiring in July 2025[76](index=76&type=chunk)[77](index=77&type=chunk) - As of March 31, 2025, a **right-of-use asset** of **$152 thousand** and a **lease liability** of **$154 thousand** are reflected on the balance sheet[78](index=78&type=chunk) - Rent expense was **$118 thousand** for the three months ended March 31, 2025, compared to **$110 thousand** for the same period in 2024[78](index=78&type=chunk) Future Operating Lease Payments (in thousands) as of March 31, 2025 | Year | Amount | | :--- | :----- | | 2025 | $156 | | Total Lease Payments | $156 | | Less: imputed interest | $(2) | | Total operating lease liabilities | $154 | [5. Warrants](index=21&type=section&id=5.%20Warrants) This note details outstanding warrants, their exercise prices, expiration dates, and cashless exercises during the quarter Outstanding Warrants as of March 31, 2025 | Description | Number of Common Shares Issuable | Exercise Price | Expiration Date | | :-------------------------- | :------------------------------- | :------------- | :-------------- | | January 23 2017 Warrants | 5,450 | $0.10 | Upon M&A Event | | 2019 Warrants | 690,813 | $19.50 | February 2026 | | March 2020 Coverage Warrants | 2,594,503 | $21.10 | Jan - March 2027 | | Total | 3,290,766 | | | - During Q1 2025, **824,718** March 2020 Pre-funded Warrants, **591,603** September 2021 Pre-funded Warrants, and **1,523,404** April 2024 Pre-funded Warrants were **cashless exercised**, resulting in the issuance of common shares[82](index=82&type=chunk)[83](index=83&type=chunk)[84](index=84&type=chunk) - The 2017 Warrants, which had a down round feature, expired in November 2024[81](index=81&type=chunk) [6. Common Stock](index=22&type=section&id=6.%20Common%20Stock) This note outlines common stockholder rights and details a private placement completed in April 2024 - Each share of common stock entitles the holder to one vote, and common stockholders are entitled to dividends if declared, subject to preferred stockholders' rights. No dividends have been declared through March 31, 2025[87](index=87&type=chunk) - In April 2024, the company completed a **private placement**, issuing **12,660,993 shares** of common stock and **1,523,404** prefunded warrants, generating aggregate net proceeds of **$37.1 million**[88](index=88&type=chunk) [7. Equity Incentive Plans](index=22&type=section&id=7.%20Equity%20Incentive%20Plans) This note describes the company's equity incentive plans, summarizing stock option and RSU activity, and stock-based compensation expense - As of March 31, 2025, there were **2,688,242 shares** available for grant under the company's **equity incentive plans**[91](index=91&type=chunk) Stock Option Activity (as of March 31, 2025) | Item | Options | Weighted Average Exercise Price Per Share | | :-------------------------- | :-------- | :------------------------------------ | | Outstanding at Dec 31, 2024 | 6,416,744 | $8.43 | | Exercised | (6,667) | $2.40 | | Forfeited | (130,411) | $53.90 | | Outstanding at Mar 31, 2025 | 6,279,666 | $7.49 | - No stock options or RSUs were granted during the three months ended March 31, 2025[93](index=93&type=chunk)[94](index=94&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $634 | $627 | | General and administrative | $570 | $621 | | Total | $1,204 | $1,248 | [8. Net Loss Per Share](index=24&type=section&id=8.%20Net%20Loss%20Per%20Share) This note details the calculation of basic and diluted net loss per share, identifying anti-dilutive securities excluded from the calculation Net Loss Per Share (in thousands, except share and per share amounts) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Net loss attributable to common stockholders | $(15,435) | $(13,820) | | Weighted average common shares outstanding | 41,268,894 | 27,014,100 | | Net loss per share (basic and diluted) | $(0.37) | $(0.51) | Potentially Dilutive Securities Excluded from EPS Calculation (anti-dilutive effect) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Restricted stock units to purchase common stock | — | 227,500 | | Options to purchase common stock | 6,279,666 | 4,867,984 | | Warrants to purchase common stock | 3,285,316 | 3,586,373 | | Total | 9,564,982 | 8,681,857 | [9. Commitments and Contingencies](index=25&type=section&id=9.%20Commitments%20and%20Contingencies) This note details the company's commitments and contingencies, including manufacturing, insurance, license agreements, and legal proceedings - As of March 31, 2025, the company had **$98 thousand** in noncancelable commitments under **manufacturing agreements** for **DKN-01**[101](index=101&type=chunk) - In March 2025, the company financed **$440 thousand** in **insurance premiums** at an **8.74%** fixed annual interest rate, with an outstanding principal of **$363 thousand** as of March 31, 2025[102](index=102&type=chunk) - The company has **license agreements** with Eli Lilly and Company and a **collaboration agreement** with Adimab, LLC, which may require future royalty and milestone payments upon product commercialization, though none have been paid or accrued through March 31, 2025[103](index=103&type=chunk)[104](index=104&type=chunk) - The company is not currently a party to any **material legal proceedings** and has not incurred material costs from **indemnification agreements**[105](index=105&type=chunk)[106](index=106&type=chunk) [10. Subsequent Events](index=25&type=section&id=10.%20Subsequent%20Events) This note discloses a significant restructuring approved on May 6, 2025, to reduce cash burn and prioritize key clinical and preclinical programs - On May 6, 2025, the board approved a **restructuring** to reduce **cash burn** and prioritize clinical development of **sirexatamab (DKN-01)** in **CRC** and preclinical development of **FL-501**[107](index=107&type=chunk) - The **restructuring** involved a **workforce reduction of approximately 50%** (**13** full-time employees reduced, **3** converted to part-time, plus **11** prior departures)[107](index=107&type=chunk) - The company expects to incur one-time costs of approximately **$350 thousand** to **$450 thousand** related to **termination benefits**, mostly recognized in Q2 2025[107](index=107&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's discussion and analysis of the company's financial condition, operations, and liquidity, emphasizing the need for additional funding [Company Overview](index=27&type=section&id=Company%20Overview) This section provides a high-level overview of Leap Therapeutics, Inc.'s business, focus, and operational funding - **Leap Therapeutics** is a **biopharmaceutical company** focused on developing biomarker-targeted antibody therapies for cancer, with **sirexatamab (DKN-01)** as its lead clinical program for **colorectal cancer**[109](index=109&type=chunk)[110](index=110&type=chunk) - The company has no approved products or revenue from product sales, funding operations primarily through common and preferred stock sales and notes payable[111](index=111&type=chunk) [Recent Developments](index=27&type=section&id=Recent%20Developments) This section highlights recent progress in the company's clinical programs and strategic corporate actions - Updated preliminary data from Part B of the **DeFianCe Study** (**Phase 2**) of **sirexatamab (DKN-01)** in combination with bevacizumab and chemotherapy in MSS CRC patients showed positive results[113](index=113&type=chunk) - In patients with **high DKK1 levels** (upper quartile, n=44), the Sirexatamab Arm showed a **32%** higher ORR and **3.5 month** longer PFS compared to the Control Arm - In patients who had not received prior **anti-VEGF therapy** (n=95), the Sirexatamab Arm had a **22%** higher ORR and **2.6 month** longer PFS compared to the Control Arm - These strong signals support a registrational **Phase 3 clinical trial** for **sirexatamab (DKN-01)** in second-line MSS CRC patients with **high DKK1 levels** or **no prior anti-VEGF therapy**[113](index=113&type=chunk) - New preclinical data for **FL-501**, a **GDF-15 neutralizing antibody** targeting cachexia, was presented at **AACR 2025**, demonstrating a longer half-life, reduced clearance, and effectiveness in countering cisplatin-induced weight loss in models[119](index=119&type=chunk) - The company announced a **strategic restructuring** to prioritize **sirexatamab (DKN-01)** in **CRC** and **FL-501** preclinical development, resulting in approximately a **50% workforce reduction**[119](index=119&type=chunk) [Financial Overview](index=28&type=section&id=Financial%20Overview) This section provides a summary of the company's financial performance and key expense categories - Research and development expenses are expected to increase in the foreseeable future to support product candidate development, primarily **sirexatamab (DKN-01)**[118](index=118&type=chunk) - General and administrative expenses are anticipated to increase due to continued research activities and public company compliance costs[126](index=126&type=chunk) - Research and development incentive income is derived from the Australian government's R&D Incentive Program, providing a **refundable tax offset** for eligible R&D expenses[128](index=128&type=chunk) [Critical Accounting Policies and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section discusses the company's critical accounting policies and estimates that require significant management judgment - Critical accounting policies involve significant judgment and complexity, including accrued research and development expenses, research and development incentive receivable, and **stock-based compensation**[132](index=132&type=chunk)[134](index=134&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) This section analyzes the company's financial results for the reporting period compared to the prior year Summary of Results of Operations (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :----------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Research and development | $12,911 | $11,299 | $1,612 | | General and administrative | $3,006 | $3,526 | $(520) | | Total operating expenses | $15,917 | $14,825 | $1,092 | | Loss from operations | $(15,917) | $(14,825) | $(1,092) | | Interest income | $437 | $775 | $(338) | | Australian research and development incentives | $55 | $246 | $(191) | | Net loss | $(15,435) | $(13,820) | $(1,615) | - Research and development expenses increased by **$1.6 million**, primarily due to higher clinical trial costs for the **DeFianCe Study** and manufacturing costs[136](index=136&type=chunk) - General and administrative expenses decreased by **$0.5 million**, driven by a reduction in professional fees and **stock-based compensation**[137](index=137&type=chunk) - Interest income decreased by **$0.3 million** due to a lower average cash and cash equivalent balance[138](index=138&type=chunk) - Australian R&D incentive income decreased from **$0.2 million** in Q1 2024 to **$0.1 million** in Q1 2025[139](index=139&type=chunk) [Financial Position, Liquidity and Capital Resources](index=32&type=section&id=Financial%20Position%2C%20Liquidity%20and%20Capital%20Resources) This section discusses the company's financial position, liquidity, capital resources, and ongoing funding needs - The company has not achieved profitable operations or positive cash flows from operations since inception and expects continued operating losses[142](index=142&type=chunk)[143](index=143&type=chunk) - As of March 31, 2025, cash and cash equivalents were **$32.7 million**, and the accumulated deficit was **($482.8 million)**, leading to substantial doubt about the company's ability to continue as a **going concern**[143](index=143&type=chunk) - Additional funding is required through equity financings, government programs, or collaboration agreements; failure to obtain this could force delays or reductions in clinical trials and R&D programs[144](index=144&type=chunk) [Cash Flows](index=32&type=section&id=Cash%20Flows) This section analyzes the company's cash flows from operating, investing, and financing activities Summary of Cash Flows (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :----------------------------------- | :-------------------------------- | :-------------------------------- | | Cash used in operating activities | $(14,480) | $(15,516) | | Cash provided by (used in) financing activities | $(61) | $29 | | Net decrease in cash and cash equivalents | $(14,536) | $(15,722) | - Net cash used in operating activities decreased by **$1.0 million**, primarily due to changes in working capital, partially offset by the net loss[146](index=146&type=chunk)[147](index=147&type=chunk) - Net cash used in financing activities was **($61 thousand)** in Q1 2025, compared to **$29 thousand** provided in Q1 2024, mainly due to principal payments of insurance financing[148](index=148&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms no applicable quantitative and qualitative disclosures about market risk for the company - The company has no applicable quantitative and qualitative disclosures about market risk[149](index=149&type=chunk) [Item 4. Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of disclosure controls and procedures, confirming their effectiveness and no material changes in internal control - Management, with the participation of the **CEO and CFO** (also serving as CFO), concluded that **disclosure controls and procedures were effective** as of March 31, 2025[151](index=151&type=chunk) - **No changes in internal control** over financial reporting materially affected, or are reasonably likely to affect, internal control over financial reporting during the three months ended March 31, 2025[152](index=152&type=chunk) [PART II — OTHER INFORMATION](index=34&type=section&id=PART%20II%20%E2%80%94%20OTHER%20INFORMATION) This section contains other information not covered in the financial statements, including legal proceedings, risk factors, and exhibits [Item 1. Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) This section confirms the company is not currently involved in any material legal proceedings - The company is not currently a party to any **material legal proceedings**[154](index=154&type=chunk) [Item 1A. Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section highlights the high investment risk, emphasizing substantial doubt about the company's ability to continue as a going concern - An investment in the company's ordinary shares involves a **high degree of risk**[155](index=155&type=chunk) - Management concluded that substantial doubt exists about the company's ability to continue as a **going concern** due to the need for additional capital and uncertainties in raising such funding[156](index=156&type=chunk) - Failure to raise sufficient additional capital could lead to inability to fund operations, develop product candidates, or realize asset value, potentially resulting in liquidation and loss of investment for stockholders[156](index=156&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section reports no unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities - No unregistered sales of equity securities, use of proceeds, or issuer purchases of equity securities to report[157](index=157&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section reports no defaults upon senior securities - No defaults upon senior securities to report[158](index=158&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section reports no applicable mine safety disclosures for the company - No mine safety disclosures to report[159](index=159&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) This section provides additional information on a strategic restructuring, workforce reduction, and confirms no Rule 10b5-1 trading arrangements - On May 6, 2025, the board approved a **restructuring** to reduce **cash burn** and prioritize clinical development of **sirexatamab (DKN-01)** in **CRC** and preclinical advancement of **FL-501**[160](index=160&type=chunk) - The **restructuring** involved a **workforce reduction of approximately 50%**, leading to expected one-time costs of **$0.35 million** to **$0.45 million**, primarily for **termination benefits**[160](index=160&type=chunk) - No director or officer adopted or terminated a **Rule 10b5-1 trading arrangement** during the three months ended March 31, 2025[162](index=162&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL financial statements - The exhibit index includes certifications by the **CEO and CFO** (Rule 13a-14(a) and 18 U.S.C. Section 1350) and **XBRL formatted financial statements**[166](index=166&type=chunk) [Signatures](index=37&type=section&id=SIGNATURES) This section contains the required signatures for the filing, certifying its accuracy and completeness [Authorized Signatory](index=37&type=section&id=Authorized%20Signatory) This section confirms the official signing of the report by the registrant's authorized signatory - The report was signed on May 12, 2025, by **Douglas E. Onsi**, **President, Chief Executive Officer, and Chief Financial Officer**[170](index=170&type=chunk)

Core Insights - Leap Therapeutics, Inc. announced preclinical data for FL-501, a monoclonal antibody targeting GDF-15, at the AACR Annual Meeting, highlighting its potential in treating cancer cachexia [1][2][3] Group 1: Product Development - FL-501 is engineered for higher affinity to GDF-15 and has a longer plasma half-life compared to competing therapies [5][7] - In preclinical models, FL-501 fully restored body composition, showing effectiveness comparable or superior to clinical-stage antibodies like visugromab and ponsegromab [7] - The company plans to advance FL-501 into clinical trials in 2026 [3] Group 2: Disease Context - Cancer cachexia is a severe condition leading to significant weight loss and reduced quality of life, contributing to cancer-related mortality [3] - High levels of GDF-15 are associated with cancer cachexia symptoms such as loss of appetite and weight loss [5] Group 3: Presentation Details - The poster presentation for FL-501 will take place on April 29, 2025, at the AACR Annual Meeting, under the session category of Experimental and Molecular Therapeutics [5]