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About Leap Therapeutics
Leap Therapeutics, Inc. (Nasdaq: LPTX) is a clinical-stage biopharmaceutical company specializing in the development of targeted antibody therapies and immuno-oncology treatments for cancer. Operating at the forefront of oncology research, Leap Therapeutics focuses on creating innovative therapies that address unmet medical needs in treating specific cancer types. The company's work is grounded in cutting-edge science, targeting tumor-promoting pathways, cancer-specific cell surface molecules, and activating the immune system to combat cancer cells effectively.
Core Business Areas
The company's primary therapeutic focus is on monoclonal antibody development, with two advanced programs in clinical trials:
- DKN-01: A humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, which is implicated in tumor growth and immune suppression. DKN-01 is being developed for esophagogastric, gynecologic, and colorectal cancers through multiple clinical trials, including the DeFianCe and DisTinGuish studies.
- FL-301: A monoclonal antibody targeting Claudin18.2, a biomarker associated with gastric and pancreatic cancers. This program represents a novel approach to targeting specific cancer cell populations.
Additionally, Leap Therapeutics is advancing preclinical programs such as FL-302 and FL-501, which target Claudin18.2/CD137 and GDF15, respectively, to expand their portfolio of transformative cancer treatments.
Business Model and Market Position
Leap Therapeutics operates as a single-segment entity focused exclusively on oncology. The company generates revenue primarily through collaborations, licensing agreements, and partnerships with other biopharmaceutical companies. For instance, Leap collaborates with BeiGene, NovaRock, and Adimab to enhance its research and development capabilities. Leap's business model is heavily reliant on external funding, including private placements and institutional investments, to support its R&D activities and clinical trials. The company has successfully attracted partnerships with leading investors and organizations, underscoring its credibility in the biotech space.
Industry Context and Challenges
Leap Therapeutics operates in the highly competitive biotechnology and oncology sectors, characterized by rapid innovation and significant regulatory scrutiny. Key challenges include:
- High R&D costs and the inherent risks of clinical trial failures.
- Regulatory hurdles in gaining approvals for new therapies.
- Competition from other biotech firms specializing in targeted and immuno-oncology therapies.
However, Leap differentiates itself through its focus on biomarker-driven therapies, which aim to provide personalized treatment options for patients. By targeting specific cancer biomarkers like DKK1 and Claudin18.2, Leap positions itself as a pioneer in precision medicine within oncology.
Significance in Oncology
The company's innovative approach to cancer therapy has the potential to address critical gaps in the treatment of aggressive cancers. By leveraging advanced antibody technologies and focusing on tumor-specific pathways, Leap Therapeutics contributes to the broader goal of improving patient outcomes in oncology.
Conclusion
Leap Therapeutics is a key player in the biotechnology sector, with a strong focus on developing targeted and immuno-oncology therapeutics. Its commitment to addressing unmet medical needs in cancer therapy, coupled with its innovative pipeline and strategic collaborations, positions the company as a significant contributor to the advancement of oncology research. While challenges persist, Leap's biomarker-driven approach and focus on precision medicine underscore its potential to make a lasting impact in the fight against cancer.
Leap Therapeutics, Inc. (Nasdaq:LPTX) closed a public offering of 27,568,072 shares of common stock, raising approximately $104 million. This amount includes $7.25 million from collaborator BeiGene, Ltd. The offering included the additional sale of 4,740,000 shares due to underwriters' exercised options and 8,771,928 pre-funded warrants. Piper Sandler, Raymond James, and Mizuho acted as book-running managers. Proceeds will assist in advancing Leap's clinical programs, particularly for their leading candidate, DKN-01, which targets various cancers.
Leap Therapeutics (Nasdaq:LPTX) announced a public offering of common stock priced at $2.85 per share, alongside pre-funded warrants at $2.849 each. This offering is projected to raise approximately $90 million in gross proceeds, anticipated to close around September 24, 2021. The company will use the funds for further development of its drug candidate DKN-01, manufacturing clinical trial materials, and general corporate purposes. The offering includes an option for underwriters to purchase an additional 4,740,000 shares.
Leap Therapeutics (Nasdaq:LPTX) announced a proposed public offering of common stock and pre-funded warrants on Sept. 21, 2021. The offering will include a 30-day option for underwriters to purchase an additional 15%. Proceeds will fund the development of DKN-01, manufacturing clinical trial materials, and general corporate purposes. The offering is subject to market and regulatory conditions. Piper Sandler, Raymond James, and Mizuho Securities will act as book-running managers. The securities are part of an effective shelf registration.
Leap Therapeutics (Nasdaq:LPTX) presented updated positive data from the DisTinGuish study at the ESMO Congress. This Phase 2a clinical trial evaluated DKN-01, an anti-Dickkopf-1 antibody, in combination with tislelizumab and chemotherapy for gastric cancer patients. Results indicated a 68.2% overall response rate (ORR), with 90% in patients with high DKK1 expression. Notably, treatment efficacy was observed irrespective of PD-L1 expression levels. The company plans to discuss these findings further in a conference call on September 17, 2021.
Leap Therapeutics (Nasdaq:LPTX) will present initial data from the Phase 2a DisTinGuish study at the ESMO Congress from September 16-21, 2021. This study evaluates DKN-01, an anti-Dickkopf-1 antibody, combined with BeiGene's tislelizumab and chemotherapy in patients with gastric or gastroesophageal junction cancer. Preliminary results show a compelling overall response rate (ORR) of 68.2% for all patients, with a notable 90% ORR in DKK1-high patients. A conference call on September 17, 2021 will discuss these findings further.
Leap Therapeutics (Nasdaq: LPTX), a biotechnology firm focused on immuno-oncology therapeutics, announced that its CEO, Douglas E. Onsi, will present at two virtual investor conferences:
- H.C. Wainwright 23rd Annual Global Investment Conference: September 13, 2021, at 7:00 a.m. ET
- Baird 2021 Global Healthcare Conference: September 15, 2021, at 3:10 p.m. ET
Webcasts of both events will be available on the company's Investor page. Leap is advancing its clinical candidate, DKN-01, targeting multiple cancers.
Leap Therapeutics, Inc. (LPTX) reported a net loss of $9.5 million for Q2 2021, up from $6.5 million in 2020. License revenues remained stable at $0.4 million. Research and development expenses increased to $7.2 million, largely due to higher payroll and clinical trial costs. General and administrative expenses rose to $2.8 million. Cash reserves stood at $35.7 million as of June 30, 2021. The company completed enrollment in the DisTinGuish study for DKN-01 and plans to present initial data at the ESMO Congress in September 2021.
Leap Therapeutics, Inc. (Nasdaq: LPTX) announced its participation in the European Society for Medical Oncology (ESMO) Congress from September 16-21, 2021. The company will present initial findings from the DisTinGuish Phase 2a study, evaluating DKN-01, an anti-DKK1 antibody, combined with tislelizumab in treating gastric or gastroesophageal junction cancer. A conference call is scheduled for September 16, 2021, to discuss these results. The study, involving 25 patients, aims to improve treatment responses in G/GEJ cancer.
Leap Therapeutics (Nasdaq: LPTX) announced that its CEO, Douglas E. Onsi, will present a corporate overview at the Ladenburg Thalmann 2021 Virtual Healthcare Conference on July 14, 2021, at 1:00 p.m. ET. The presentation will be available live and as a replay on the company's Investors page.
Leap focuses on targeted and immuno-oncology therapeutics, with its lead candidate, DKN-01, in trials for various cancers. The company has a partnership with BeiGene for DKN-01 development in Asia and oceania.
Leap Therapeutics (Nasdaq: LPTX) announced that Douglas E. Onsi, CEO, will present a corporate overview at the Raymond James 2021 Virtual Human Health Innovation Conference on June 21, 2021, at 1:20 p.m. ET. The presentation will be accessible via the company's Investors page, with a replay available later. Leap is focused on developing immuno-oncology therapeutics, with DKN-01 as its leading candidate targeting DKK1 in various cancer types. The company has partnered with BeiGene for DKN-01 development in several regions excluding Japan.
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