Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), a clinical-stage biopharmaceutical company, focuses on the development of therapeutics for the treatment of liver diseases. The company is developing Aramchol, an oral therapy, which is in ARREST study, a Phase IIb clinical study for the treatment of patients with overweight or obesity, and who are pre-diabetic or type-II-diabetic with non-alcoholic steato-hepatitis.
June 12, 2018.Galmed announced top-line, 52-week results from the global Phase 2b ARREST study. In the ARREST study, patients underwent MRS and biopsy at baseline and week 52, which were centrally read, blinded to treatment allocation. The primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by MRS (Aramchol 600mg vs. placebo).
About Aramchol™ and Non-alcoholic Steatohepatitis (NASH)
Aramchol™ (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol™’s ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol™ on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol™ has been granted Fast Track designation status by the FDA for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.
Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company, focuses on the development of therapeutics for the treatment of liver diseases. The company is developing Aramchol, an oral therapy, which is in ARREST study, a Phase IIb clinical study for the treatment of patients with overweight or obesity, and who are pre-diabetic or type-II-diabetic with non-alcoholic steato-hepatitis. It also evaluates Aramchol through ARRIVE Study, a proof-of-concept Phase IIa clinical trial, with HIV-associated non-alcoholic fatty liver disease and lipodystrophy. The company was founded in 2000 and is headquartered in Tel Aviv, Israel. Galmed Pharmaceuticals Ltd. is a subsidiary of Galmed International Ltd.
March-15-18 Upgrade Maxim Group Hold → Buy Target $14
Financial review Q1 2018
Cash and cash equivalents and marketable securities totaled $15.5 million as of March 31, 2018, compared to $19.0 million at December 31, 2017.
Net loss of $2.5 million, or $0.17 per share, for the three months ended March 31, 2018, compared to a net loss of $3.2 million, or $0.26 per share, for the three months ended March 31, 2017.
The Company recognized $0.3 million of revenue for the three months ended March 31, 2018, the same amount as in the corresponding quarter in 2017.
Research and development (“R&D”) expenses amounted to approximately $1.9 million for the three months ended March 31, 2018, compared to approximately $2.7 million for the three months ended March 31, 2017.
General and administrative expenses amounted to approximately $0.9 million for the three months ended March 31, 2018, compared to approximately $0.8 million for the three months ended March 31, 2017.
Financial expenses amounted to $0.05 million for the three months ended March 31, 2018, compared to financial income of $0.1 million for the three months ended March 31, 2017.
Stock influences and risk factors
Continuing positive results from clinical trials could acts as a catalyst for the company shares;
Their foreign currency exposures give rise to market risk associated with exchange rate movements of the Euro and NIS mainly against the U.S. dollar because a large portion of their expenses are denominated in Euros and NIS;
Their primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates;
They maintain significant amounts of cash and cash equivalents at one or more financial institutions that are in excess of federally insured limits.
On Tuesday, June 12, 2018, GLMD shares were at $20.41 (+191.57%) on traded volume of 11.3 million shares. The current RSI is 93.69
At $20.41, GLMD shares are trading above their 50 DMA and 200 DMA of $6.50 and $7.74 respectively.
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