Page 1

leaptherapeutics Leap Therapeutics Reports Third Quarter 2021 Financial Results November 12 , 2021 CAMBRIDGE , Mass . , Nov. 12 , 2021 / PRNewswire / -- Leap Therapeutics , Inc. ( Nasdaq : LPTX ) , a biotechnology company focused on developing targeted and immuno - oncology therapeutics , today reported financial results for the third quarter ended September 30 , 2021 . Leap Third Quarter Highlights : • Completed a $ 103.6 million public offering of common stock and pre - funded warrants to purchase common stock , resulting in net proceeds of $ 96.8 million • Presented positive initial data from the DisTinGuish Study of DKN - 01 plus tislelizumab and chemotherapy in gastric cancer patients at the European Society for Medical Oncology ( ESMO ) Congress 2021 " We presented positive new data at ESMO of DKN - 01 in combination with BeiGene's tislelizumab and chemotherapy demonstrating compelling overall response rates in patients with first - line gastric or gastroesophageal junction ( G / GEJ ) cancer , particularly those patients whose tumors expressed high levels of DKK1 or low PD - L1 , " said Douglas E. Onsi , President and Chief Executive Officer of Leap . " We look forward to presenting additional data from the DisTinGuish study early next year and aggressively advancing DKN - 01 into the next stages of development in G / GEJ and other cancers . " Business Update • Leap Completed a $ 103.6 Million Public Offering of Common Stock and Pre - Funded Warrants to Purchase Common Stock - In September 2021 , Leap announced the commencement and closing of an underwritten public offering of 27,568,072 shares of its common stock , including the sale of an additional 4,740,000 shares of its common stock pursuant to the full exercise of the underwriters ' option to purchase additional shares , and of pre - funded warrants to purchase 8,771,928 shares of its common stock . Aggregate gross proceeds to Leap from the offering were $ 103.6 million , including $ 7.25 million invested by its collaborator and existing investor BeiGene , Ltd. , resulting in net proceeds after underwriting discounts and commissions and offering expenses of $ 96.8 million . DKN - 01 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 . • Initial Data from the DisTinGuish Clinical Trial of DKN - 01 Plus Tislelizumab and Chemotherapy Presented at ESMO Congress 2021. The Company presented initial positive data from the first - line cohort of the Phase 2a study in patients with G / GEJ cancer . Of the 25 first - line HER2- G / GEJ patients who received a full cycle of DKN - 01 therapy , overall response rate ( ORR ) was 68.2 % , with 90 % ORR in DKK1 - high patients and 56 % in DKK1 - low patients . Among those patients with PD - L1 - low expression , ORR was 79 % ( with 100 % ORR in DKK1 - high patients and 57 % ORR in DKK1 - low patients ) , and in patients with PD - L1 - high expression , ORR was 67 % ( with 75 % ORR in DKK1 - high patients and 50 % in DKK1 - low patients ) , suggesting response to DKN - 01 was independent of PD - L1 expression . Selected Third Quarter 2021 Financial Results Net Loss was $ 11.1 million for the third quarter 2021 , compared to $ 7.1 million for the same period in 2020 . License revenues were $ 0.4 million for each of the third quarter 2021 and the same period in 2020 , and relate to the Agreement with BeiGene for the development and commercialization of DKN - 01 in Asia ( excluding Japan ) , Australia , and New Zealand . Research and development expenses were $ 10.1 million for the third quarter 2021 , compared to $ 5.4 million for the same period in 2020. The increase of $ 4.7 million in research and development expenses was due to an increase of $ 3.3 million in manufacturing costs related to clinical trial material due to timing of manufacturing campaigns , an increase of $ 0.7 million in clinical trial costs due to timing of patient enrollment , an increase of $ 0.6 million in payroll and other related expenses due to an increase in headcount of our research and development full time employees , 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 $ 2.4 million for the third quarter 2021 , compared to $ 2.5 million for the second quarter 2020. The decrease of $ 0.1 million in general and administrative expenses was due to a $ 0.4 million decrease in professional fees partially offset by an increase of a $ 0.2 million in stock based compensation expense due to new stock options granted to general and administrative full time employees in 2021 and an increase of $ 0.1 million in payroll and other related expenses . Cash and cash equivalents totaled $ 124.8 million at September 30 , 2021. Research and development incentive receivables totaled $ 1.6 million at September 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 collaboration 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/ .