LPTX Leap Therapeutics Inc.

1.93
+0.1  (+5%)
Previous Close 1.83
Open 1.81
52 Week Low 0.5728
52 Week High 3.18
Market Cap $115,139,442
Shares 59,657,742
Float 41,019,510
Enterprise Value $50,994,442
Volume 422,699
Av. Daily Volume 756,743
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Drug Pipeline

Drug Stage Notes
DKN-01 and Tislelizumab ( DisTinGuish)
Gastric / Gastroesophageal Junction Cancer
Phase 2a
Phase 2a
Phase 2a initiation of dosing announced September 21, 2020.
DKN-01 and Paclitaxel
Endometrial Cancer
Phase 2
Phase 2
Phase 2 data noted stable disease of 55% - April 23, 2020. ORR 10% in monotherapy arm.
DKN-01 + KEYTRUDA
Esophagogastric adenocarcinoma
Phase 1/2
Phase 1/2
Phase 1/2 data August 6, 2019 noted 50% ORR.
TRX518
Solid tumors
Phase 1/2
Phase 1/2
De-prioritizing further development - November 14, 2019
DKN-01
Biliary tract cancer (BTC)
Phase 2
Phase 2
Phase 1/2 data released December 14, 2018 noted 21.3% PR rate.

Latest News

  1. CAMBRIDGE, Mass., Sept. 24, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin…

    CAMBRIDGE, Mass., Sept. 24, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DKN-01 for the treatment of patients with gastric and gastroesophageal junction (G/GEJ) adenocarcinoma whose tumors express high Dickkopf-1 protein (DKK1), following disease progression on or after prior fluoropyrimidine- and platinum- containing chemotherapy and if appropriate, human epidermal receptor growth factor (HER2)/neu-targeted therapy. DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of DKK1 protein, a modulator of Wnt/Beta-catenin signaling.

    The Fast Track program is intended to facilitate the development and expedite the review of drug candidates and vaccines that treat serious conditions and fill an unmet medical need. The purpose of Fast Track is to get important new drugs to the patient earlier. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. DKN-01 has also received Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer from the FDA.

    "We are pleased with the FDA's decision to grant Fast Track designation for the development of DKN-01 to treat patients with gastric and gastroesophageal junction cancer whose tumors express high levels of DKK1," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "The designation highlights the existing unmet medical need for new and effective treatments for this patient population. We believe that DKN-01 shows promise as a novel treatment option for biomarker-selected patients with these cancers, and this designation provides us with earlier and more frequent opportunities to interact with the FDA during the development of DKN-01."

    DKN-01 is currently being evaluated in clinical trials for gastroesophageal, gynecologic, hepatobiliary, and prostate cancers. In September 2020, the first patient was dosed in the Company's combination study of DKN-01 plus tislelizumab, BeiGene, Ltd.'s anti-PD-1 antibody, in patients with gastric or gastroesophageal junction cancer.

    About DKN-01

    DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has 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 ligands on tumor cells.

    About gastric / gastroesophageal junction cancer

    Gastric adenocarcinoma (gastric cancer) remains one of the most common and deadly cancers worldwide, especially among older malesi. Based on GLOBOCAN 2018 data, stomach cancer is the 5th most common neoplasm and the 3rd most deadly cancer, with an estimated 783,000 deaths globally in 2018i. Ninety-five percent of cancers of the stomach are adenocarcinomasi. Gastric cancer incidence and mortality are highly variable by region and highly dependent on diet and Helicobacter pylori infectioni. The gastroesophageal junction (GEJ) is the area where the esophagus and stomach join together. Given its anatomic location, GEJ adenocarcinomas have often been grouped together with either esophageal or gastric cancers in clinical trials.

    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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a 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/.

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports Leap files from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. Leap undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACT:

    Douglas E. Onsi

    President & Chief Executive Officer

    Leap Therapeutics, Inc.

    617-714-0360

    Heather Savelle

    Investor Relations

    Argot Partners

    212-600-1902

    i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444111/

    Leap Therapeutics logo (PRNewsfoto/LEAP Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/leap-therapeutics-announces-fda-fast-track-designation-granted-to-dkn-01-for-the-treatment-of-gastric-and-gastroesophageal-junction-cancer-301137115.html

    SOURCE Leap Therapeutics, Inc.

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  2. CAMBRIDGE, Mass. and BEIJING, Sept. 21, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, and BeiGene, Ltd., (NASDAQ:BGNE, HKEX: 06160))), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the first patient has been dosed in the DisTinGuish study, a Phase 2a clinical trial evaluating Leap's investigational anti-Dickkopf-1 antibody (DKK1), DKN-01, in combination with tislelizumab, BeiGene's anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ).

    "Dosing of the first patient in the DisTinGuish study…

    CAMBRIDGE, Mass. and BEIJING, Sept. 21, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, and BeiGene, Ltd., (NASDAQ:BGNE, HKEX: 06160))), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the first patient has been dosed in the DisTinGuish study, a Phase 2a clinical trial evaluating Leap's investigational anti-Dickkopf-1 antibody (DKK1), DKN-01, in combination with tislelizumab, BeiGene's anti-PD-1 antibody, with or without chemotherapy, in patients with gastric or gastroesophageal junction cancer (G/GEJ).

    "Dosing of the first patient in the DisTinGuish study is a key milestone for the DKN-01 development program," said Cynthia Sirard, M.D., Chief Medical Officer of Leap Therapeutics. "We are excited to have the opportunity to combine DKN-01 with tislelizumab due to the promising signals in a DKK1 biomarker-defined population of esophagogastric cancer patients. We look forward to working closely alongside BeiGene to evaluate this potential new combination therapy for a patient population with a high global unmet medical need."  

    The DisTinGuish trial (NCT04363801) is a Phase 2a, nonrandomized, open-label, multicenter study of DKN-01 in combination with tislelizumab with or without chemotherapy as first-line or second-line therapy in adult patients with inoperable, locally advanced G/GEJ adenocarcinoma. The study, which will be conducted in two parts, is expected to enroll up to 72 patients.

    Part A will enroll up to 24 patients with G/GEJ adenocarcinoma who have received no prior systemic treatment in the locally advanced/metastatic setting (first-line treatment), and Part B will enroll up to 48 patients with previously treated, inoperable, locally advanced or metastatic DKK1-high G/GEJ adenocarcinoma (second-line treatment). The study is designed to evaluate safety, tolerability, and efficacy of the combination therapy of intravenous DKN-01 and tislelizumab ± CAPOX (capecitabine + oxaliplatin) in G/GEJ adenocarcinoma patients. Treatment will be conducted in repeating 21-day cycles until the patient meets pre-established criteria for discontinuation or is no longer deriving clinical benefit. Part A and Part B of the study will be conducted concurrently.

    Leap is conducting this combination study in the United States 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. Leap retains exclusive rights for the development, manufacturing and commercialization of DKN-01 for the rest of the world.

    About DKN-01

    DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling, a signaling pathway frequently implicated in tumorigenesis and suppressing the immune system. DKK1 has 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 ligands on tumor cells. DKN-01 has received Orphan Drug Designation for the treatment of gastric and gastroesophageal junction cancer from the U.S. Food and Drug Administration.

    About Tislelizumab

    Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin's lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

    In addition, three supplemental new drug applications (sNDAs) for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review – for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

    Tislelizumab is not approved for use outside of China.

    About gastric / gastroesophageal junction cancer

    Gastric adenocarcinoma (gastric cancer) remains one of the most common and deadly cancers worldwide, especially among older malesi. Based on GLOBOCAN 2018 data, stomach cancer is the 5th most common neoplasm and the 3rd most deadly cancer, with an estimated 783,000 deaths globally in 2018i. Ninety-five percent of cancers of the stomach are adenocarcinomas i.  Gastric cancer incidence and mortality are highly variable by region and highly dependent on diet and Helicobacter pylori infectioni. The gastroesophageal junction (GEJ) is the area where the esophagus and stomach join together. Given its anatomic location, GEJ adenocarcinomas have often been grouped together with either esophageal or gastric cancers in clinical trials.

    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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has entered into a 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/.

    About BeiGene

    BeiGene is a global, commercial-stage biotechnology company focused on discovering, developing, manufacturing, and commercializing innovative medicines to improve treatment outcomes and access for patients worldwide. Our 4,200+ employees in China, the United States, Australia, Europe, and elsewhere are committed to expediting the development of a diverse pipeline of novel therapeutics. We currently market two internally discovered oncology products: BTK inhibitor BRUKINSA® (zanubrutinib) in the United States and China, and anti-PD-1 antibody tislelizumab in China. We also market or plan to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneUSA.

    LEAP FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include statements relating to Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    BEIGENE FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding plans for the advancement of, anticipated clinical development and regulatory milestones, and the potential opportunity of DKN-01 and tislelizumab as a combination therapy. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene's ability to achieve commercial success for its marketed products and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct drug development, manufacturing and other services; BeiGene's limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of the COVID-19 pandemic on the Company's clinical development, commercial and other operations, as well as those risks more fully discussed in the section entitled "Risk Factors" in BeiGene's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

    LEAP CONTACTS:

    Douglas E. Onsi

    President & Chief Executive Officer

    Leap Therapeutics, Inc.

    617-714-0360

    Heather Savelle

    Investor Relations

    Argot Partners

    212-600-1902

     

    BEIGENE CONTACTS:

    Investor Relations

    Craig West

    +1 857-302-5189

    Media Relations

    Liza Heapes or Vivian Ni

    +1 857-302-5663 or +1 857-302-7596

     

    i https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6444111/

     

    Leap Therapeutics logo (PRNewsfoto/LEAP Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/leap-therapeutics-and-beigene-announce-first-patient-dosed-in-study-of-dkn-01-in-combination-with-tislelizumab-for-the-treatment-of-metastatic-gastric-or-gastroesophageal-junction-cancer-301134397.html

    SOURCE Leap Therapeutics, Inc.

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  3. CAMBRIDGE, Mass., Sept. 9, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced that Douglas E. Onsi, President and Chief Executive Officer, will present a corporate overview at the H.C. Wainwright 22nd Annual Global Investment Conference, being held virtually on September 14-16, 2020.

    Leap Presentation Details:

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date: Wednesday, September 16

    Presentation Time: 3:00 p.m. Eastern Time

    The presentation will be webcast live and may be accessed on the Investors page of the company's website at https://investors.leaptx.com/, where a replay of the event will also be available for a limited time.

    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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has formed a 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/.

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACT:

    Douglas E. Onsi

    President & Chief Executive Officer

    Leap Therapeutics, Inc.

    617-714-0360

    Heather Savelle

    Investor Relations

    Argot Partners

    212-600-1902

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/leap-therapeutics-to-present-at-hc-wainwright-22nd-annual-global-investment-conference-301126144.html

    SOURCE Leap Therapeutics, Inc.

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  4. CAMBRIDGE, Mass., Aug. 24, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced the expansion of its leadership team with the appointment of Jason S. Baum, Ph.D., as Vice President, Head of Translational Medicine and Christine M. Granfield as Vice President, Head of Regulatory Affairs and Quality.

    "It is my pleasure to welcome Jason and Chris to the team," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Their expertise in the development and approval of novel therapies will prove invaluable as we advance our DKN-01 monoclonal antibody as a treatment for patients with multiple biomarker-defined cancers. We are…

    CAMBRIDGE, Mass., Aug. 24, 2020 /PRNewswire/ -- Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, today announced the expansion of its leadership team with the appointment of Jason S. Baum, Ph.D., as Vice President, Head of Translational Medicine and Christine M. Granfield as Vice President, Head of Regulatory Affairs and Quality.

    "It is my pleasure to welcome Jason and Chris to the team," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "Their expertise in the development and approval of novel therapies will prove invaluable as we advance our DKN-01 monoclonal antibody as a treatment for patients with multiple biomarker-defined cancers. We are excited to have them join us to lead and build out these critical functional areas."

    Dr. Baum joins Leap with more than a dozen years of industry experience. Most recently, he served as Executive Director and Precision Medicine Leader, General Medicine and Lung Cancer with Novartis Oncology Precision Medicine. Prior to joining Novartis, Dr. Baum held various positions of increasing responsibility with Merrimack Pharmaceuticals, including as Director, Head of Diagnostics and Biomarkers. He started his career as a Product Scientist with Cell Signaling Technology. Dr. Baum holds a Ph.D. in Molecular Biology, Cell Biology and Biochemistry and an M.A. in Biology from Boston University. He holds a B.A. in Biology from Colgate University.

    Ms. Granfield joins Leap with more than 25 years of industry experience. Prior to joining Leap, she served as an independent regulatory consultant with Granfield Associates LLC. Previously, she was Senior Director, Regulatory Affairs with Novartis Corporation Oncology Business Unit, where she led the development of regulatory strategy and submissions for companion diagnostics supporting various oncology personalized medicine programs. Prior to her position with Novartis, Ms. Granfield served as Senior Director, Regulatory Affairs with Genzyme Corporation. She also held positions with Boston Scientific Corporation. Ms. Granfield has a BSE, Biomedical Engineering from The Catholic University of America and is a member of the Regulatory Affairs Professional Society.

    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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has formed a 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/.  

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    Contact:

    Douglas E. Onsi

    President & Chief Executive Officer

    Leap Therapeutics, Inc.

    617-714-0360

    Heather Savelle

    Investor Relations

    Argot Partners

    212-600-1902

    Leap Therapeutics logo (PRNewsfoto/LEAP Therapeutics)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/leap-therapeutics-expands-leadership-team-with-addition-of-two-industry-veterans-301116610.html

    SOURCE Leap Therapeutics, Inc.

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  5. CAMBRIDGE, Mass., Aug. 13, 2020 /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, 2020.

    Leap Second Quarter Highlights:

    • Completed a $51.75 million public offering of common stock and pre-funded warrants to purchase common stock
    • Presented updated data for DKN-01 monotherapy that showed a complete response and partial response in endometrial cancer patients with additional responses observed for the DKN-01 plus paclitaxel combination in carcinosarcoma patients
    • Announced Orphan Drug Designation of DKN-01 for the treatment of gastric and gastroesophageal junction cancer

    "Our partnership…

    CAMBRIDGE, Mass., Aug. 13, 2020 /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, 2020.

    Leap Second Quarter Highlights:

    • Completed a $51.75 million public offering of common stock and pre-funded warrants to purchase common stock
    • Presented updated data for DKN-01 monotherapy that showed a complete response and partial response in endometrial cancer patients with additional responses observed for the DKN-01 plus paclitaxel combination in carcinosarcoma patients
    • Announced Orphan Drug Designation of DKN-01 for the treatment of gastric and gastroesophageal junction cancer

    "Our partnership with BeiGene for the clinical development and commercialization of DKN-01 is progressing extremely well, and we look forward to dosing the first patient this quarter in the combination study of DKN-01 plus tislelizumab, BeiGene's anti-PD-1 antibody, for the treatment of gastric or gastroesophageal junction cancer patients," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "DKN-01 continues to show potential to treat multiple biomarker-defined cancers, as both a single agent and in combination with chemotherapy or anti-PD-1 therapies. We are excited about the promise of this program and, with the proceeds from our recent public offering, are well funded to drive development forward."

    Business Update

    • Leap Completed $51.75 Million Public Offering of Common Stock and Pre-Funded Warrants to Purchase Common Stock – In June 2020, Leap announced the closing of an underwritten public offering yielding aggregate gross proceeds of $51.75 million, before deducting underwriting discounts and commissions and other offering expenses payable by Leap.

    DKN-01 Clinical Update

    DKN-01 is a humanized monoclonal antibody that binds to and blocks the activity of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment.

    • Leap Presented Updated Data for DKN-01 Monotherapy and Paclitaxel Combination in Gynecologic Cancers – Leap announced updated clinical data from its ongoing Phase 2 clinical trial of DKN-01, as both a monotherapy and in combination with paclitaxel chemotherapy, in patients with advanced gynecological malignancies. Leap hosted a conference call with Rebecca Arend, M.D., Assistant Professor and Associate Scientist, Gynecologic Oncology Clinic, The University of Alabama at Birmingham School of Medicine Comprehensive Cancer Center Experimental Therapeutics Program, on April 23, 2020, to discuss the data. Key findings from the P204 study include the following:
      • DKN-01 Monotherapy in Endometrial Cancer: Twenty-nine endometrial cancer patients were enrolled in the DKN-01 monotherapy arm, over 75% of whom had experienced three or more prior lines of therapy. Of those patients, 26 were evaluable for response. In the 20 patients with a Wnt signaling alteration, one patient (5%) has an ongoing complete response, one patient (5%) had a partial response, eight patients (40%) had a best response of stable disease, and 10 patients (50%) had progressive disease, representing an overall response rate (ORR) of 10% and a disease control rate (DCR) of 50%. In the group of six patients without any Wnt signaling alterations, one patient (16.6%) had a best response of stable disease and five patients (83.3%) had progressive disease.
      • DKN-01 plus Paclitaxel in Carcinosarcoma: Fifteen patients with carcinosarcoma were enrolled in the DKN-01 plus paclitaxel arm, six of whom were evaluable for response as of the data-cutoff date. Two patients (33%) have had a partial response, one patient (17%) has had a best response of stable disease, and three patients (50%) had progressive disease, representing an ORR of 33% and a DCR of 50%. Nine patients had not reached their first tumor assessment.
    • Leap Announced Orphan Drug Designation of DKN-01 for the Treatment of Gastric and Gastroesophageal Junction Cancer – Leap announced that the U.S. Food and Drug Administration (FDA) granted the Company Orphan Drug Designation for DKN-01 for the treatment of gastric and gastroesophageal junction cancer. The FDA's Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides to Leap certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees, and tax credits for qualified clinical trials.

    Selected Second Quarter 2020 Financial Results

    Net loss was $6.5 million for the second quarter 2020, compared to $8.4 million for the same period in 2019. This decrease was primarily due to revenue recognized from the BeiGene agreement, a decrease in clinical development expenses and non-cash foreign currency gains associated with changes in the Australian dollar exchange rate related to certain manufacturing activities.

    Research and development expenses were $5.4 million for the second quarter 2020, compared to $6.1 million for the same period in 2019.  The decrease was primarily due to lower clinical trial costs due to timing of patient enrollment and lower consulting fees associated with research and development activities.

    General and administrative expenses were $2.5 million for the second quarter 2020, compared to $2.3 million for the same period in 2019. The increase was primarily due to higher legal, audit and consulting fees associated with corporate and business development activities.

    Cash, cash equivalents and marketable securities totaled $64.9 million at June 30, 2020. Research and development incentive receivables, current and long term, totaled approximately $0.3 million at June 30, 2020.

    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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric, hepatobiliary, gynecologic, and prostate cancers. Leap has formed a 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/.

    FORWARD-LOOKING STATEMENTS

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements include Leap's expectations with respect to the development and advancement of DKN-01, including the initiation, timing and design of future studies, enrollment in future studies, potential for the receipt of future option exercise, milestones or royalty payments from BeiGene, and other future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. Such risks and uncertainties include, but are not limited to: that the initiation, conduct, and completion of clinical trials, laboratory operations, manufacturing campaigns, and other studies may be delayed, adversely affected, or impacted by COVID-19 related issues, the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates; the size and growth potential of the markets for our drug product candidates; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially will be included in Leap Therapeutics' periodic filings with the SEC, including Leap's Annual Report on Form 10-K for the fiscal year ended December 31, 2019, as filed with the SEC on March 16, 2020 and as may be updated by Leap's Quarterly Reports on Form 10-Q and the other reports we file from time to time with the SEC. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

    CONTACT:

    Douglas E. Onsi

    President & Chief Executive Officer

    Leap Therapeutics, Inc.

    617-714-0360

    Heather Savelle

    Investor Relations

    Argot Partners

    212-600-1902

    Leap Therapeutics, Inc.

    Condensed Consolidated Statements of Operations

    (in thousands, except share and per share amounts)























    (Unaudited)



    (Unaudited)





    Three Months Ended June 30, 



    Six Months Ended June 30, 





    2020



    2019



    2020



    2019



















    License revenue



    $          375



    $            -



    $          750



    $            -

    Operating expenses:

















    Research and development



    5,350



    6,136



    9,953



    12,926

    General and administrative 



    2,521



    2,325



    4,674



    4,330

    Total operating expenses



    7,871



    8,461



    14,627



    17,256

    Loss from operations



    (7,496)



    (8,461)



    (13,877)



    (17,256)

    Interest income 



    20



    119



    88



    201

    Interest expense  



    (13)



    (9)



    (25)



    (16)

    Australian research and development incentives



    30



    61



    115



    136

    Foreign currency gains (loss)



    943



    (76)



    (48)



    (34)

    Net loss



    (6,516)



    (8,366)



    (13,747)



    (16,969)

    Dividend attributable to down round feature of warrants



    -



    -



    (303)



    (359)

    Dividend attributable to Series A & B convertible preferred stock



    -



    -



    (372)



    -

    Series A & B convertible preferred stock - beneficial conversion feature 



    -



    -



    (9,399)



    -

    Net loss attributable to common stockholders



    $      (6,516)



    $      (8,366)



    $    (23,821)



    $    (17,328)



















    Net loss per share 

















    Basic



    $       (0.12)



    $       (0.37)



    $       (0.57)



    $       (0.82)

    Diluted



    $       (0.12)



    $       (0.37)



    $       (0.57)



    $       (0.82)



















    Weighted average common shares outstanding 

















    Basic



    52,442,597



    22,906,025



    42,037,405



    21,081,869

    Diluted



    52,442,597



    22,906,025



    42,037,405



    21,081,869

     

    Leap Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (in thousands, except share and per share amounts)



















    June 30, 



    December 31, 







    2020



    2019















    (Unaudited)





    Assets















    Current assets:











    Cash and cash equivalents



    $       64,887



    $             3,891



    Research and development incentive receivable



    181



    185



    Prepaid expenses and other current assets



    212



    165



    Total current assets



    65,280



    4,241















    Property and equipment, net



    81



    124



    Right of use assets



    711



    1,026



    Research and development incentive receivable, net of current portion



    124



    -



    Deferred tax assets



    125



    127



    Deferred costs



    413



    831



    Deposits





    939



    1,099



    Total assets



    $       67,673



    $             7,448











    Liabilities and Stockholders' Equity (Deficiency)









    Current liabilities:











    Accounts payable



    $        2,716



    $             4,571



    Accrued expenses



    2,232



    3,441



    Deferred revenue - current portion



    1,500



    -



    Lease liability - current portion



    388



    474



    Total current liabilities



    6,836



    8,486













    Non current liabilities:











    Restricted stock liability



    -



    159



    Deferred revenue, net of current portion



    750



    -



    Lease liability, net of current portion



    354



    552



    Total liabilities



    7,940



    9,197













    Stockholders' equity (deficiency):











    Common stock, $0.001 par value; 240,000,000 shares authorized; 59,657,742 and











    24,194,877 shares issued and outstanding as of June 30, 2020 and











    December 31, 2019, respectively



    60



    24



    Additional paid-in capital



    268,770



    193,319



    Accumulated other comprehensive income 



    121



    76



    Accumulated deficit 



    (209,218)



    (195,168)



    Total stockholders' equity (deficiency)



    59,733



    (1,749)



    Total liabilities and stockholders' equity (deficiency)



    $       67,673



    $             7,448

     

     Leap Therapeutics, Inc. 

     Condensed Consolidated Statements of Cash Flows 

     (in thousands) 



















     (Unaudited) 



















     Six Months Ended June 30 



















    2020



    2019





















     Cash used in operating activities 





    $  (13,377)



    $  (14,051)

     Cash provided by (used in) investing activities 





    25



    (100)

     Cash provided by financing activities 





    74,382



    13,582

     Effect of exchange rate changes on cash and cash equivalents 





    (34)



    32

     Net increase in cash and cash equivalents 





    60,996



    (537)

     Cash and cash equivalents at beginning of period 





    3,891



    16,284

     Cash and cash equivalents at end of period 





    $   64,887



    $   15,747

     

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