Core Insights - Leap Therapeutics reported financial results for Q4 and the full year 2024, highlighting advancements in their lead product, sirexatamab, and a decrease in net loss compared to 2023 [1][9]. Product Development - The company advanced sirexatamab through Phase 2 clinical trials, showing promising data in patients with high DKK1 levels and those without prior anti-VEGF therapy, which represent significant portions of the second-line colorectal cancer (CRC) market [2][4][12]. - A registrational Phase 3 clinical trial is planned to evaluate sirexatamab in combination with bevacizumab and chemotherapy for second-line MSS CRC patients [4]. - The potential market opportunity for sirexatamab includes approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next seven largest markets, with a focus on patients with high DKK1 levels and those who have not received prior anti-VEGF therapy [5]. Financial Performance - Leap Therapeutics reported a net loss of $67.6 million for the year ended December 31, 2024, a decrease from $81.4 million in 2023, primarily due to reduced research and development expenses [9][10]. - Research and development expenses for 2024 were $57.2 million, down from $73.2 million in 2023, with Q4 expenses at $13.1 million compared to $11.7 million in the same period of 2023 [10]. - General and administrative expenses decreased to $12.8 million for the full year 2024 from $13.8 million in 2023, with Q4 expenses at $3.0 million [11]. Cash Position - As of December 31, 2024, the company had cash and cash equivalents totaling $47.2 million, down from $70.6 million at the end of 2023 [11][18]. Upcoming Events - Leap Therapeutics will present preclinical data for FL-501 at the 2025 American Association for Cancer Research (AACR) Annual Meeting, with plans to begin clinical trials in 2026 [7].

Core Insights - Leap Therapeutics has presented updated data from the DeFianCe study, indicating that sirexatamab in combination with bevacizumab and chemotherapy shows statistically significant improvements in overall response rate (ORR) and progression-free survival (PFS) for colorectal cancer (CRC) patients with high DKK1 levels and those who have not received prior anti-VEGF therapy [1][2][3] Study Results - In patients with high DKK1 levels (n=44), the sirexatamab Experimental Arm demonstrated a 32% higher ORR (48.0% vs. 15.8%) and a median PFS of 9.36 months compared to 5.88 months in the Control Arm [3][4] - For patients without prior anti-VEGF therapy (n=95), the sirexatamab Experimental Arm showed a 22% higher ORR (55.1% vs. 32.6%) and a median PFS of 10.94 months compared to 8.34 months in the Control Arm [4][3] - Across the intent-to-treat population (n=188), the sirexatamab Experimental Arm had an ORR of 36.2% compared to 25.5% in the Control Arm, with median PFS still maturing [4][3] Market Opportunity - The combination therapy has a significant market opportunity, targeting approximately 30,000 second-line treated CRC patients in the US and 160,000 in the next seven largest markets, particularly among the 25-50% of patients with high DKK1 levels and the 50% who have not received prior anti-VEGF therapy [7] - There is potential to expand into first-line CRC treatment, with an estimated 45,000 patients in the US and 265,000 in the next seven largest markets [7] Future Plans - Leap Therapeutics is considering a registrational Phase 3 clinical trial to further evaluate the efficacy of sirexatamab in the identified patient populations [7][2] - The company has engaged a leading financial advisor to explore business development opportunities to advance the development of sirexatamab [7]

Group 1 - Leap Therapeutics is a precision medicine developer focusing on novel targets for managing solid tumors [1] - The company's main drug is currently undergoing multiple mid-stage clinical tests as an add-on to approved therapies [1] Group 2 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1] - The mission is to educate investors on the science behind biotech businesses to aid in due diligence [1]

Company Overview - Leap Therapeutics, Inc. is a biotechnology company focused on developing targeted and immuno-oncology therapeutics [3] - The company's most advanced clinical candidate is DKN-01, a humanized monoclonal antibody targeting the Dickkopf1 (DKK1) protein, which is being developed for esophagogastric, colorectal, and gynecological cancers [3] - Leap's pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 (GDF-15) protein, currently in preclinical development [3] Upcoming Events - Douglas E. Onsi, President and CEO of Leap Therapeutics, will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference [1] - The event is scheduled for December 4, 2024, at 4:00 p.m. Eastern Time, and will be accessible via a live webcast on the company's Investors page [2]

Financial Performance - Net loss for Q3 2024 was $18.2 million, an increase from $13.7 million in Q3 2023, primarily due to higher research and development expenses [6]. - Total operating expenses for Q3 2024 were $17.9 million, compared to $14.8 million in Q3 2023 [12]. - The accumulated deficit increased to $451.9 million as of September 30, 2024, from $399.6 million at the end of 2023 [13]. Research and Development - Research and development expenses rose to $14.9 million in Q3 2024, up from $11.5 million in Q3 2023, reflecting a $3.4 million increase driven by clinical trial costs and manufacturing expenses [7]. - Enrollment completed for 188 patients in the expanded Part B of the Phase 2 DeFianCe study, with initial data expected in mid-2025 [3]. - Patient follow-up ongoing for 170 patients in Part C of the DisTinGuish study, with initial data anticipated in late 2024 or early 2025 [4]. - FL-501, a new anti-GDF-15 monoclonal antibody, has been initiated for development based on promising preclinical data [5]. Cash Position - Cash and cash equivalents totaled $62.8 million as of September 30, 2024, down from $70.6 million at the end of 2023 [8]. - The company expects its cash position to fund operations into Q2 2026, indicating a strong financial runway for ongoing projects [2]. - Cash used in operating activities for Q3 2024 was $(15,600) thousand, compared to $(10,488) thousand in Q3 2023, reflecting a 49.1% increase in cash outflow year-over-year [14]. - Cash provided by investing activities was $48,969 thousand, indicating a stable investment position [14]. - Cash provided by financing activities was $(66) thousand, a slight increase from $(1) thousand in the previous year [14]. - The net decrease in cash and cash equivalents for Q3 2024 was $(15,656) thousand, compared to $(10,672) thousand in Q3 2023, representing a 46.5% increase in cash depletion [14]. - Cash and cash equivalents at the end of Q3 2024 stood at $62,823 thousand, down from $80,743 thousand at the end of Q3 2023 [14]. - Cash and cash equivalents at the beginning of the period were $78,479 thousand, compared to $91,415 thousand in the previous year [14]. - The effect of exchange rate changes on cash and cash equivalents was a positive $10 thousand, contrasting with a negative $(183) thousand in Q3 2023 [14]. - Total cash and cash equivalents decreased by $17,920 thousand from the beginning to the end of the period [14]. - The company experienced a significant cash outflow in operating activities, indicating potential challenges in managing operational expenses [14]. - The overall financial position shows a decrease in cash reserves, necessitating a review of future funding strategies [14]. General and Administrative Expenses - General and administrative expenses decreased to $2.9 million in Q3 2024 from $3.3 million in Q3 2023, due to lower professional fees [8].

Core Insights - Leap Therapeutics reported financial results for Q3 2024, highlighting significant advancements in its clinical pipeline and financial performance [1][2]. Pipeline Developments - Enrollment completed in the expanded randomized controlled Part B of the Phase 2 DeFianCe study for DKN-01 in advanced colorectal cancer, with data expected in mid-2025 [2][3]. - Patient follow-up is ongoing in Part C of the Phase 2 DisTinGuish study for DKN-01 in advanced gastroesophageal junction and gastric cancer, with initial data anticipated in late 2024 or early 2025 [2][3]. - Development of FL-501, an anti-GDF-15 monoclonal antibody, has been initiated based on promising preclinical data [2][4]. Financial Performance - The net loss for Q3 2024 was $18.2 million, an increase from $13.7 million in Q3 2023, primarily due to higher research and development expenses [5]. - Research and development expenses rose to $14.9 million in Q3 2024 from $11.5 million in Q3 2023, driven by increased manufacturing and clinical trial costs [6]. - General and administrative expenses decreased to $2.9 million in Q3 2024 from $3.3 million in Q3 2023 [7]. - Cash and cash equivalents stood at $62.8 million as of September 30, 2024, expected to fund operations into Q2 2026 [2][7].

Financial Performance - Total operating expenses for Q3 2024 were $17,855,000, an increase of 20% compared to $14,833,000 in Q3 2023[10]. - Net loss for Q3 2024 was $18,176,000, compared to a net loss of $13,696,000 in Q3 2023, representing a 33% increase in losses[11]. - Basic and diluted net loss per share for Q3 2024 was $0.44, an improvement from $0.51 in Q3 2023[10]. - Comprehensive loss for Q3 2024 was $18,173,000, compared to $13,350,000 in Q3 2023, indicating a 36% increase in comprehensive losses[11]. - Net loss for the nine months ended September 30, 2024, is $52,124,000, compared to a net loss of $68,949,000 for the same period in 2023, representing a 24% improvement[19]. - The accumulated deficit as of September 30, 2024, was $451.9 million, with a net loss of $52.4 million incurred during the nine months ended September 30, 2024[95]. Research and Development - Research and development expenses for the nine months ended September 30, 2024, were $44,099,000, down 28% from $61,549,000 for the same period in 2023[10]. - The DKN-01 program accounted for $14.8 million in R&D expenses in Q3 2024, up from $11.0 million in Q3 2023, reflecting a $3.8 million increase[86]. - Research and development expenses for Q3 2024 were $14.9 million, an increase of $3.4 million from $11.5 million in Q3 2023[86]. - The company continues to develop DKN-01 and other programs, with ongoing collaborations with BeiGene, NovaRock, and Adimab[3]. - The company is advancing FL-501 into development as a potential best-in-class anti-GDF-15 antibody, with promising preclinical data indicating increased body weight and restored muscle mass in models[75]. - Enrollment completed in the expanded randomized controlled Part B of the DeFianCe study with 188 patients, evaluating DKN-01 in combination with standard care for advanced colorectal cancer[73]. Cash and Liquidity - The company had cash and cash equivalents of $62.823 million at the end of the period, a decrease from $80.743 million at the end of the previous period[19]. - Cash used in operating activities was $44.8 million for the nine months ended September 30, 2024, compared to $33.4 million in the same period in 2023[96]. - Cash and cash equivalents as of September 30, 2024, were $62.8 million, expected to fund operating expenses for at least the next 12 months[95]. - The company experienced a net decrease in cash and cash equivalents of $7.8 million for the nine months ended September 30, 2024, compared to an increase of $15.2 million in 2023[96]. Funding and Equity - Leap Therapeutics completed a private placement in April 2024, raising $39.999 million[19]. - The company plans to seek additional funding through public or private equity financings or collaboration agreements with larger pharmaceutical companies[24]. - The company has not generated any product sales revenues and has not achieved profitable operations since inception[24]. - The total number of common shares outstanding as of September 30, 2024, was 38,264,464[16]. - The company issued 1,972,901 shares of common stock to Flame stockholders as part of the acquisition completed on January 17, 2023[56]. Expenses - General and administrative expenses for Q3 2024 were $2.9 million, a decrease of $0.4 million from $3.3 million in Q3 2023, primarily due to lower professional fees[87]. - The company anticipates an increase in general and administrative expenses in the future as it expands headcount to support ongoing research and development activities[79]. - Stock-based compensation expenses for the nine months ended September 30, 2024, were $3,957,000, slightly up from $3,875,000 in the same period of 2023[19]. Tax and Foreign Currency - The provision for income taxes in Q3 2024 was $708,000, while there was no provision in Q3 2023[10]. - The company reported a foreign currency loss of $8,000 in Q3 2024, compared to a loss of $501,000 in Q3 2023[10]. - The company recorded a foreign currency translation adjustment of $632 thousand for the nine months ended September 30, 2023[19]. Clinical Trials and Product Development - The company has ongoing clinical trials for its lead program DKN-01, targeting multiple cancer types[21]. - Initial data from Part B of the DeFianCe study is expected to be reported in mid-2025, while initial data from Part C of the DisTinGuish study is anticipated in late 2024 or early 2025[73]. - The company has the ability to delay or reduce certain clinical trials or research and development programs if additional funding is not obtained[24].

Company Overview - Leap Therapeutics, Inc. is a biotechnology company focused on developing targeted and immuno-oncology therapeutics [3] - The company's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf1 (DKK1) protein, being developed for esophagogastric, gynecologic, and colorectal cancers [3] Study Update - Enrollment of 188 patients has been completed in Part B of the DeFianCe study, which evaluates DKN-01 in combination with standard care bevacizumab and chemotherapy for advanced colorectal cancer (CRC) [1][2] - The DeFianCe study is a Phase 2, open-label, global study, with the primary endpoint being progression-free survival (PFS) [2] - Part B of the study expanded from 130 to 188 patients, and an additional primary endpoint will measure PFS in patients with left-sided CRC [2] Clinical Data and Expectations - Initial data from Part B, including results for the subpopulation of patients with left-sided CRC, is expected to be shared in mid-2025 [2] - Encouraging data from Part A of the study showed clinically meaningful response rates and durable tumor reductions, along with a favorable safety profile in advanced CRC patients [2]

Financial Performance - Net loss for Q2 2024 was $20.4 million, an increase from $13.4 million in Q2 2023, primarily due to higher research and development expenses[7]. - General and administrative expenses decreased to $3.4 million in Q2 2024 from $3.6 million in Q2 2023[8]. - Cash used in operating activities for the six months ended June 30, 2024, was $(29,187) thousand, compared to $(22,885) thousand for the same period in 2023, representing an increase in cash outflow of approximately 27.7%[16]. - Total liabilities rose to $15,638 thousand from $12,684 thousand, reflecting an increase of about 23.0%[14]. - The accumulated deficit increased to $(433,764) thousand from $(399,582) thousand, indicating a decline in retained earnings[15]. - Total stockholders' equity increased to $65,788 thousand from $60,141 thousand, reflecting an increase of approximately 9.0%[15]. Research and Development - Overall response rate (ORR) increases to 33% across all evaluable patients and 38% for left-sided CRC patients in the Phase 2 DeFianCe study evaluating DKN-01[2]. - Research and development expenses rose to $17.9 million in Q2 2024 from $11.1 million in Q2 2023, driven by increased clinical trial costs[7]. - Enrollment in Part B of the DeFianCe study expanded to 180 patients, with completion expected by the end of September 2024[4]. - Initial data from the randomized controlled Part C of the DisTinGuish study is anticipated in Q4 2024 or early 2025[5]. - The company expects to report initial data from both randomized controlled studies over the next 12 months[3]. Cash and Assets - Cash and cash equivalents totaled $78.5 million as of June 30, 2024[8]. - Cash and cash equivalents at the end of the period were $78,479 thousand, compared to $70,643 thousand at the end of the previous period, marking an increase of approximately 11.5%[16]. - The company reported a net increase in cash and cash equivalents of $23,558 thousand for the three months ended June 30, 2024, compared to a net decrease of $(10,623) thousand in the same period in 2023[16]. - Total current assets increased to $79,587 thousand from $71,597 thousand, representing an increase of approximately 11.1%[14]. - Total assets increased to $81,426 thousand from $72,825 thousand, representing an increase of approximately 11.0%[14]. - Cash provided by financing activities was $37,117 thousand for the three months ended June 30, 2024, compared to no cash provided in the same period in 2023[16]. Clinical Outcomes - Median progression-free survival (PFS) for left-sided tumor patients was 8.6 months, unchanged from previous data[4]. - Research and development incentive receivable decreased slightly to $754 thousand from $771 thousand[14].

CAMBRIDGE, Mass., Aug. 12, 2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today reported financial results for the second quarter ended June 30, 2024. Leap Highlights: Overall response rate (ORR) increases to 33% across all evaluable patients and 38% across evaluable patients with left-sided CRC in updated data from Part A of the Phase 2 DeFianCe study evaluating DKN-01 in combination with bevacizumab and c ...