Leap Therapeutics Inc (LPTX)LPTX

Leap Therapeutics Inc. Overview

Company Profile:

History & Background:

Leap Therapeutics Inc. (TSX:LPT) is a Toronto-based pharmaceutical development company specializing in discovering, developing, and commercializing new therapeutic options for patients with severe and life-threatening oncology indications with high unmet need. Founded in 2007 with a headquarter in Cambridge, Massachusetts, the company leverages its proprietary DOVIDO platform to identify and refine small molecules that inhibit known and novel cancer targets.

Leadership & Structure:

Leap Therapeutics boasts a diverse senior leadership team with extensive expertise in scientific research and development of cancer therapeutics. Led by CEO, Daniel A. Harrington, the team includes proven veterans with experience in drug discovery, development, clinical research, operations, and finance. Leap Therapeutics operates as a board-led organization, overseen by an experienced independent board of directors with expertise in strategic decision making, fundraising, and governance, providing the essential framework for success.

Top Products & Market Share:

Although Leap Therapeutics currently has no marketed drugs, its two lead product candidates, DZD9008 (INCB 054329) and DOV712, have garnered attention within several oncology fields.

• DZD9008: This small-molecule kinase modulator targets the mTOR pathway (AKT/mTOR/S6K1). Leap partnered with Incyte Corporation in 2020 (who now holds exclusive worldwide rights), to explore its potential for several cancers, including urothelial and head and neck.

• DOV712: A DOT1L-targeting protein methyltransferase inhibitor, DOV712 has shown promise in pre-clinical and clinical studies demonstrating antitumor activity as a single agent and in combination therapies for several types of leukemia.

While the company currently lacks its own product on the market, the performance and reception of these candidates within their respective treatment fields will significantly influence their market share once commercialized.

Total Addressable Market:

The global oncology drug market, encompassing the treatment of numerous cancer types, represents an immense target for Leap Therapeutics. In 2022, this market was valued at a staggering $172.2 billion and is projected to reach $240 billion by 2026, due in part to the rising cancer prevalence, advancements in therapies, and growing access to healthcare globally.

Financial Performance:**

Fiscal 2022 Highlights:

• Achieved several key milestones across its pipeline of novel oncology therapies: received orphan drug designation in Europe and US for its lead product DOV712, initiated a phase 2 study evaluating DZD9008 in locally advanced or metastatic bladder cancer in combination with platinum-based chemotherapy, and commenced its fourth dose escalation cohort in a Phase 1/1b study of DOV712.
• Generated $30.3 million in cash from a public offering, significantly bolstering its balance sheet and allowing continued investment in pipeline development programs.
• Incurred a net loss (attributable to shareholders) of $60.5 million for the full fiscal year; however, this is expected for a clinical-stage biopharma company focusing on R&D.

Growth Trajectory:

Although currently pre-revenue and operating at a net loss, investors anticipate significant positive growth for Leap and its stock in the mid to long term. This optimism stems from ongoing research, promising pre-clinical and clinical data from DZD9008 and DOV712, potential licensing agreements for its lead candidates across a variety of indications, and its strategic focus on oncology.

Furthermore, Leap has several strategic partnerships with reputable institutions and pharmaceutical companies. Their 2020 partnership with Roche granted Roche exclusive worldwide rights to develop, manufacture and commercialize a DZD9008 combination product in specific tumor types. Moreover, the company partnered with Takeda Oncology to conduct a phase IV clinical study in breast cancer evaluating the PI3K inhibitor alpelisib. These collaborations add financial and strategic resources to Leap, accelerating the advancement its pipeline and enhancing the likelihood of its success. These factors contribute to significant shareholder trust in Leap to become a profitable and leading force within the oncology space.

Market Dynamics:

The global oncology medication market is characterized by high growth potential; however, competition within the field is intense and driven by innovation. Key market dynamics include:

• Advancements in therapeutic approaches: New targeted therapeutics like Leap’s candidate oncology drugs, immunotherapies are continuously evolving the treatment landscape by offering more personalized options.
• Growing demand: Rising cancer prevalence, particularly in aging populations, contributes to a consistent increase in new diagnoses, driving demand for novel treatments.
• Rising drug costs: High treatment costs and intellectual property issues related to new oncology therapies pose challenges for access and affordability.
• Regulatory landscape: Stringent regulatory processes impact approval times, requiring significant resources from pharmaceutical companies like Leap throughout product development.

Against this background, adaptability to changing conditions is critical. Leap's focused pipeline and strong R&D efforts position the company effectively to capitalize on emerging market opportunities.

Competitors