Earnings release
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leaptherapeutics Leap Therapeutics Reports Second Quarter 2021 Financial Results and Upcoming Data Presentation August 13 , 2021 CAMBRIDGE , Mass . , Aug. 13 , 2021 / 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 , 2021 and provided upcoming company milestones . " In the first half of the year , we made significant clinical progress in the DisTinGuish study of DKN - 01 in combination with BeiGene's tislelizumab , as we completed enrollment in the first - line patient cohort , " said Douglas E. Onsi , President and Chief Executive Officer of Leap . " We look forward to presenting initial data from the study in September , which we believe will show the important potential role DKN - 01 can play for first - line gastric cancer patients , particularly those whose tumors express high levels of DKK1 where a great unmet medical need remains unaddressed . " Key DKN - 01 2021 Clinical Milestones DKN - 01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf - 1 ( DKK1 ) protein . DKK1 modulates the Wnt / Beta- catenin and Pl3kinase / AKT signaling pathways , which play an important role in tumor cell signaling and in mediating an immuno - suppressive tumor microenvironment through enhancing the activity of myeloid - derived suppressor cells and downregulating NK cell ligands on tumor cells . Leap made substantial progress with the clinical development of DKN - 01 during the first half of 2021 and has an important clinical milestone ahead this quarter : Completion of Enrollment in First - Line Cohort in the DisTinGuish Study of DKN - 01 plus Tislelizumab and Chemotherapy in Gastric Cancer . The Company announced the completion of enrollment for the first - line patient cohort in the DisTinGuish study ( NCT04363801 ) , a Phase 2a , open - label , clinical trial evaluating DKN - 01 in combination with tislelizumab , BeiGene Ltd.'s ( BeiGene ) anti - PD - 1 antibody , with or without chemotherapy , in patients with gastric or gastroesophageal junction cancer ( G / GEJ ) . The study , which is being conducted in two parts in the United States and the Republic of Korea , enrolled 25 patients with first - line G / GEJ cancer and is expected to enroll up to 48 patients with second - line G / GEJ cancer whose tumors express high levels of DKK1 . Leap is conducting this study as part of an exclusive option and license agreement with BeiGene for the development of DKN - 01 in Asia ( excluding Japan ) , Australia , and New Zealand . Initial Data from the Distinguish Study of DKN - 01 Plus Tislelizumab and Chemotherapy to be Presented at the European Society for Medical Oncology ( ESMO ) Congress 2021. The Company will be presenting initial data from the cohort of 25 first - line G / GEJ cancer patients treated with DKN - 01 in combination with tiselizumab and chemotherapy at the ESMO Congress 2021 , being held virtually on September 16-21 , 2021. Leap plans to host a conference call on Friday , September 17 , 2021 to further discuss the data . Selected Second Quarter 2021 Financial Results Net loss was $ 9.5 million for the second quarter 2021 , compared to $ 6.5 million for the same period in 2020 . License revenues were $ 0.4 million for each of the second quarter 2021 and the same period in 2020 , and relate to the exclusive option and license agreement with BeiGene for the development and commercialization of DKN - 01 in Asia ( excluding Japan ) , Australia , and New Zealand . Research and development expenses were $ 7.2 million for the second quarter 2021 , compared to $ 5.4 million for the same period in 2020. The increase of $ 1.8 million in research and development expenses was primarily due to an increase of $ 0.8 million in payroll and other related expenses due to an increase in headcount of research and development full - time employees , an increase of $ 0.6 million in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns , an increase of $ 0.3 million in clinical trial costs due to timing of patient enrollment , and an increase of $ 0.1 million in stock based compensation expense due to new stock options granted to research and development full - time employees in 2021 . General and administrative expenses were $ 2.8 million for the second quarter 2021 , compared to $ 2.5 million for the second quarter 2020. The increase of $ 0.3 million in general and administrative expenses was due to a $ 0.2 million increase in payroll and other related expenses , a $ 0.2 million increase in stock - based compensation expense due to new stock options granted to general and administrative full - time employees in 2021 , and a $ 0.1 million increase in insurance costs primarily related to an increase in our directors and officers insurance . These increases were partially offset by a $ 0.2 million decrease in professional fees primarily due to lower recruiting and information technology costs . Cash and cash equivalents totaled $ 35.7 million at June 30 , 2021. Research and development incentive receivables totaled $ 0.2 million at June 30 , 2021 . About Leap Therapeutics Leap Therapeutics ( Nasdaq : LPTX ) is focused on developing targeted and immuno - oncology therapeutics . Leap's most advanced clinical candidate , DKN - 01 , is a humanized monoclonal antibody targeting the Dickkopf - 1 ( DKK1 ) protein . DKN - 01 is in clinical trials in patients with esophagogastric , hepatobiliary , gynecologic , and prostate cancers . Leap has entered into a strategic partnership with BeiGene , Ltd. for the rights to develop DKN - 01 in Asia ( excluding Japan ) , Australia , and New Zealand . For more information about Leap Therapeutics , visit http://www.leaptx.com or view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/ . RNAscope® is a registered trademark of Advanced Cell Diagnostics , Inc. , Newark , CA , USA . FORWARD - LOOKING STATEMENTS