Leap Therapeutics is a biopharmaceutical company on the forefront of developing novel, biomarker-targeted antibody therapies designed to treat patients with cancer. The company's strategic focus is to identify, acquire, and advance transformational therapeutic candidates that have the potential to generate durable clinical benefit and enhanced patient outcomes.
Leap's Evolution and Pipeline Development
Leap Therapeutics was incorporated in the state of Delaware on January 3, 2011, and has since established itself as a rising force in the oncology space. The company's journey began with the licensing of certain intellectual property rights from Eli Lilly and Company in 2011, which laid the foundation for its lead clinical-stage program, DKN-01.
Over the years, Leap has expanded its pipeline through strategic acquisitions and partnerships. In 2015, the company formed its wholly-owned subsidiary, HealthCare Pharmaceuticals Pty Ltd., in Australia to further its research and development efforts. In the same year, Leap entered into a merger agreement with GITR Inc., an entity under common control, whereby GITR became a wholly owned subsidiary of Leap.
The 2016 merger with Macrocure Ltd., a publicly-held, clinical-stage biotechnology company based in Israel, marked a significant milestone. This merger enabled Leap to list its shares on the Nasdaq Global Market, with trading in the company's common stock commencing on January 24, 2017, under the trading symbol LPTX. In 2020, Leap's subsidiary Macrocure Ltd. was dissolved.
In 2021, Leap formed a wholly owned subsidiary called Leap Securities Corp. Throughout its history, the company has faced challenges in funding its research and development activities. To address this, Leap has raised capital through the sale of common stock and preferred stock, relying primarily on proceeds from these financing activities to fund its research and development efforts related to its lead clinical stage program, DKN-01, as well as its other earlier stage antibody programs.
It's important to note that Leap has not yet generated any revenue from product sales, as it does not have any approved products. Despite these challenges, the company has made significant progress in advancing its pipeline of oncology drug candidates since its founding in 2011.
Leap's pipeline currently comprises three key programs:
1. DKN-01: Leap's lead clinical-stage asset, a monoclonal antibody that inhibits Dickkopf-related protein 1 (DKK1), is being evaluated in multiple ongoing clinical trials for the treatment of esophagogastric cancer, gynecologic cancers, and colorectal cancer.
2. FL-301 and FL-302: These antibody programs targeting GDF-15 and other undisclosed targets are in preclinical development, with the potential to enhance immune system activity in the tumor microenvironment.
3. FL-501: A promising monoclonal antibody designed to neutralize GDF-15, which may have applications in treating cachexia and other GDF-15-driven diseases.
DKN-01: Leap's Flagship Therapy
DKN-01 is Leap's lead clinical-stage program, a monoclonal antibody that inhibits DKK1, a key regulator of the Wnt signaling pathway. DKK1 is known to play a crucial role in tumor growth, metastasis, and immune evasion, making it an attractive target for cancer therapy.
Leap is currently evaluating DKN-01 in multiple ongoing clinical trials:
- The DeFianCe study is a Phase 2, randomized, controlled trial assessing DKN-01 in combination with standard-of-care bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer. Enrollment in the expanded Part B of this study has been completed, with initial data expected in mid-2025.
- The DisTinGuish study is a Phase 2, randomized, controlled trial evaluating DKN-01 in combination with tislelizumab and chemotherapy as a first-line treatment for patients with advanced gastroesophageal junction and gastric cancer. Patient follow-up is ongoing in the randomized Part C of this study, with initial data anticipated in late 2024 or early 2025.
Leap has also entered into strategic partnerships to support the development of DKN-01. In 2020, the company entered into an Option and License Agreement with BeiGene, Ltd., granting BeiGene an option to obtain an exclusive license to develop and commercialize DKN-01 in certain Asian markets. Although BeiGene ultimately declined to exercise its option, the collaboration continues as a clinical partnership.
Expanding the Pipeline: FL-501 and Other Antibody Programs
In addition to DKN-01, Leap is advancing its pipeline of novel antibody programs, including FL-501 and FL-301/FL-302.
FL-501 is a potential best-in-class monoclonal antibody designed to neutralize growth differentiation factor-15 (GDF-15), a key driver of cancer-associated cachexia. Preclinical data has shown that FL-501 can increase body weight and restore muscle mass in animal models of cachexia. Leap is actively progressing FL-501 into clinical development, recognizing its potential to address an unmet need in this debilitating condition.
The company's other antibody programs, FL-301 and FL-302, are in preclinical stages and targeting undisclosed targets, with the goal of enhancing immune system activity in the tumor microenvironment.
Financial Overview and Liquidity
As of September 30, 2024, Leap Therapeutics reported cash and cash equivalents of $62.82 million. The company incurred a net loss of $52.12 million for the nine months ended September 30, 2024, and a net loss of $81.41 million for the full year ended December 31, 2023.
Leap's research and development expenses were $44.10 million for the nine months ended September 30, 2024, compared to $61.55 million for the same period in 2023. The decrease was primarily due to the one-time in-process research and development (IPR&D) expense of $29.58 million related to the acquisition of Flame Biosciences in 2023, which was partially offset by increases in clinical trial and manufacturing costs for the company's lead program, DKN-01.
General and administrative expenses were $9.83 million for the nine months ended September 30, 2024, compared to $10.67 million for the same period in 2023, reflecting a decrease in professional fees.
The company believes that its current cash and cash equivalents will be sufficient to fund its operating expenses for at least the next 12 months from the issuance of the Q3 2024 financial statements. Leap plans to continue seeking additional funding through public or private equity financings, government programs, and/or development program cost-sharing agreements with larger pharmaceutical or biotechnology companies to support its future operations.
In the most recent quarter, Leap reported a net loss of $18.18 million, with operating cash flow (OCF) and free cash flow (FCF) both at -$15.6 million. The company's total operating expenses for the three months ended September 30, 2024, were $17.86 million, with the majority being research and development expenses.
Leap's financial position shows a debt-to-equity ratio of 0.0077, indicating a low level of debt. The company's current ratio and quick ratio are both 3.97, suggesting strong short-term liquidity. Leap operates solely in the United States and does not have any international sales.
Product Segment Performance
Leap Therapeutics has three main product segments:
1. DKN-01 Program: As the company's lead clinical-stage program, DKN-01 accounted for $14.78 million and $43.77 million in direct research and development expenses for the three and nine months ended September 30, 2024, respectively. This significant investment reflects the program's importance in Leap's pipeline and its ongoing clinical trials in esophagogastric cancer, gynecologic cancers, and colorectal cancer.
2. FL-301 and FL-501 Programs: For the FL-501 program, Leap incurred $128,000 and $231,000 in direct research and development expenses for the three and nine months ended September 30, 2024, respectively. The FL-301 program did not incur any direct expenses in the most recent quarter but had $31,000 in expenses for the nine-month period. These investments demonstrate Leap's commitment to advancing its preclinical assets alongside its lead program.
3. In-Process R&D from Flame Acquisition: In January 2023, Leap acquired Flame Biosciences, Inc., recording $29.58 million of in-process research and development expenses related to the acquisition during the nine months ended September 30, 2023. This strategic move expanded Leap's pipeline and capabilities in the oncology space.
Navigating Challenges and Charting a Path Forward
Leap Therapeutics has encountered its fair share of challenges throughout its journey, including the ongoing development and clinical testing of its pipeline candidates. The company's ability to successfully navigate these obstacles and advance its programs has been instrumental in its progress to date.
In 2023, Leap acquired Flame Biosciences, a privately held biotechnology company, further strengthening its pipeline with a portfolio of clinical- and preclinical-stage assets. The integration of Flame's programs, particularly the GDF-15-targeting FL-501, has expanded Leap's reach and diversified its therapeutic approach.
Looking ahead, Leap remains focused on the continued development of DKN-01, with key data readouts expected in the coming years. The company's strategic collaborations, such as the partnership with BeiGene, have the potential to accelerate the global advancement of its therapies and create value for shareholders.
As Leap Therapeutics navigates the dynamic oncology landscape, the company's commitment to innovation, patient-centricity, and scientific excellence will be crucial in driving its long-term success. With a robust pipeline, a strong financial position, and a talented team, Leap is well-positioned to transform the cancer treatment paradigm and deliver meaningful solutions for patients in need.