Cambridge, MA – August 14, 2025 – Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the second quarter of 2025. Leap Highlights: DKN-01 Development Update · Reported updated clinical data from Part B of the DeFianCe study of sirexatamab plus bevacizumab and chemotherapy in CRC patients. In the updated analysis as of May 22, 2025, sirexatamab demonstrated a statistically significant benefit on o ...

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 47 Thorndike St, Suite B1-1, Cambridge, MA Address of Principal Executive Offices 27-4412575 (I.R.S. Employer Identification No.) (617) 714-0360 For the transition period from ...

Updated data from DeFianCe study continue to demonstrate statistically significant improvements in PFS among the DKK1-high, VEGF-naïve and liver metastasis subgroups Board of Directors has initiated process to explore strategic alternatives to maximize shareholder valueCAMBRIDGE, Mass., June 23, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported updated results from Part B of the DeFianCe study ( ...

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].

Table of Contents LEAP THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware State or other jurisdiction of incorporation or organization UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period ...

FL-501 fully restored body composition and reversed key indicators of cachexia in preclinical modelsFindings confirm GDF-15's role in cachexia and support advancing FL-501 into the clinicCAMBRIDGE, Mass., April 25, 2025 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced it will present preclinical data of FL-501 in a poster presentation at the American Association for Cancer Research (AACR) Annual Me ...

Core Viewpoint - Leap Therapeutics is hosting a virtual KOL event to discuss the potential of sirexatamab (DKN-01) in treating advanced microsatellite stable colorectal cancer, highlighting its clinical data and unmet medical needs [1][2][3] Company Overview - Leap Therapeutics, Inc. is a biotechnology company focused on developing targeted and immuno-oncology therapeutics, with its most advanced clinical candidate being sirexatamab, a humanized monoclonal antibody targeting the DKK1 protein [5] - The company is also developing FL-501, another humanized monoclonal antibody targeting GDF-15, which is currently in preclinical development [5] Event Details - The virtual KOL event will feature Dr. Zev A. Wainberg from UCLA, who will discuss the unmet needs in treating advanced MSS colorectal cancer and the potential improvements offered by sirexatamab [1][2] - The event will review positive data from Part B of the Phase 2 DeFianCe study, focusing on second-line patients with advanced MSS CRC [3] - A live Q&A session will follow the discussion, and a replay will be available on the company's investor page [3] Research and Development - Dr. Wainberg's research includes clinical trials for various gastrointestinal cancers, and he is currently focused on targeting cancer stem cells and molecular classification of gastrointestinal cancers [4] - Sirexatamab is being studied specifically for its efficacy in patients with colorectal cancer, addressing a significant unmet need in the treatment landscape [2][5]

Leap Therapeutics (NASDAQ:LPTX) Conference Call to discuss Updated Data from Part B of the DeFianCe Study March 26, 2025 8:00 AM ET Company Participants Douglas Onsi - President and CEO Cyndi Sirard - Chief Medical Officer Jason Baum - Chief Scientific Officer Good morning. Welcome to the Leap Therapeutics Conference Call to discuss Updated Data from Part B of the DeFianCe Study. At this time, all participants are on a listen-only mode. After the speakers' presentation, there will be a question-answer sessi ...

company presentation LEAP THERAPEUTICS Sirexatamab (DKN-01) Clinical Development DeFianCe Study Preliminary Results March 26, 2025 Forward looking statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding our strategy, future operations, clinical trials, collaborations and partnerships, future financial position, future revenues, p ...

Leap Therapeutics, Inc. LPTX presented updated preliminary data on Wednesday from Part B of the DeFianCe Phase 2 trial of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy (Experimental Arm) compared to bevacizumab and chemotherapy (Control Arm).The trial enrolled patients with advanced microsatellite stable (MSS) colorectal cancer (CRC) who have received one prior systemic therapy for advanced disease.The updated analysis shared on Wednesday includes the overall response rate (ORR), an ...