Business
Galmed Pharmaceuticals Provides Business Update and Reports Third Quarter 2019 Financial Results
TEL AVIV, Israel, Nov. 6, 2019 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":" TEL AVIV, Israel, Nov. 6, 2019 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (\"Galmed\" or the \"Company\"), a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted, oral SCD1 modulator currently in a Phase 3/4 clinical trial for the treatment of nonalcoholic steatohepatitis (\"NASH\") and fibrosis provides today a business update and reports financial results for the three and nine months ended September 30, 2019. The Company will host a conference call and webcast at 08:30 ET today.\nBusiness Development\nDuring the past quarter, the Company announced the initiation of its Phase 3/4 ARMOR, a double-blind, placebo-controlled, global study, to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis. The study is designed to consist of two parts. In the first part (Histology-Based) 1200 subjects will be treated with Aramchol or matching placebo for 52 weeks. The Histology-Based data will serve as the basis for the submission of a marketing authorization application under regulatory provisions of accelerated/conditional approval. In the second part (clinically-based), all subjects will continue with the same treatment assignment until study completion to confirm clinical efficacy.\nThe ARMOR study will be conducted in approximately 185 sites in the U.S., Europe, Latin America and Asia and the Company aims to complete enrollment by the second quarter of 2021 and report top-line results by the fourth quarter of 2022.\nFinancial Summary - Third Quarter 2019 vs. Third Quarter 2018:\nCash and cash equivalents, short-term deposits and marketable securities totaled $79.7 million as of September 30, 2019, compared to $90.2 million at December 31, 2018. Net loss of $4.5 million, or ($0.21) per share, for the three months ended September 30, 2019, compared to a net loss of $1.0 million, or ($0.05) per share, for the three months ended September 30, 2018. Research and development expenses amounted to approximately $4.1 million for the three months ended September 30, 2019, compared to approximately $1.7 million for the three months ended September 30, 2018. The increase resulted primarily from an increase in clinical, pre-clinical trial expenses and drug development expenses related to our continuing preparations of the ARMOR trial. General and administrative ...