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Leap Therapeutics, Inc. (Nasdaq: LPTX) is a pioneering clinical-stage biopharmaceutical company focused on developing novel targeted antibody therapies for cancer treatment. Headquartered in Cambridge, Massachusetts, Leap Therapeutics aims to discover and advance transformative cancer treatments by targeting tumor-promoting pathways, cancer-specific cell surface molecules, and activating the immune system against cancer cells.
The company's lead program, DKN-01, is a humanized monoclonal antibody that targets Dickkopf-related protein 1 (DKK1). This promising candidate is in clinical trials for treating esophagogastric, gynecologic, and colorectal cancers. Another key program, FL-301, targets Claudin18.2-expressing cells and is being developed for gastric and pancreatic cancer treatments. Leap Therapeutics also has two preclinical antibody programs, FL-302 and FL-501, which are advancing toward developing innovative cancer therapies.
Operating as a single segment dedicated to oncology, Leap Therapeutics has established several strategic collaborations to enhance its development pipeline, including a clinical collaboration with BeiGene for the DisTinGuish trial and partnerships with NovaRock Biotherapeutics and Adimab. The company's dedication to advancing targeted and immuno-oncology therapeutics underscores its commitment to addressing unmet needs in cancer treatment. Leap's research and development activities continue to make significant progress, with ongoing clinical trials and new data demonstrating the potential efficacy and safety of its therapeutic candidates.
In recent news, Leap Therapeutics announced the completion of enrollment in the randomized controlled Part C of the DisTinGuish study, evaluating DKN-01 in combination with tislelizumab and chemotherapy for advanced gastroesophageal junction and gastric cancer. Additionally, the company reported financial results for the first quarter of 2024, highlighting a successful $40 million financing that extends its cash runway into the second quarter of 2026. This funding will support the expansion and continued execution of the DKN-01 development program, including the expansion of the randomized controlled Part B of the DeFianCe study in second-line colorectal cancer patients.
For more information about Leap Therapeutics, visit www.leaptx.com or view their public filings with the SEC available via EDGAR at www.sec.gov or www.investors.leaptx.com.
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.
Leap Therapeutics, Inc. (Nasdaq:LPTX) reported a net loss of $9.1 million for Q1 2021, up from $7.2 million in Q1 2020. The increase was driven by heightened development activities for its DKN-01 program and expanded headcount. License revenues remained steady at $0.4 million. R&D expenses rose to $6.8 million, reflecting more clinical trial costs and staffing. Leap completed enrollment in the DisTinGuish study, evaluating DKN-01 in gastric cancer, and presented promising data on DKN-01's efficacy in gynecological malignancies. Cash reserves stood at $43.5 million as of March 31, 2021.
Leap Therapeutics (Nasdaq: LPTX) and Flagship Biosciences have developed an innovative image analysis RNAscope assay for prospective patient enrollment in clinical trials. This assay, validated in a recent publication, aims to identify patients likely to benefit from the DKN-01 therapy for gastric and gastroesophageal junction adenocarcinoma. The collaboration enhances clinical development through improved screening accuracy and efficiency, utilizing digital analysis to minimize manual errors. The DKN-01 antibody targets the DKK1 protein, linked to poor patient prognosis.
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