Galmed Pharmaceuticals Ltd. , a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol™, an oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH and fibrosis, reports financial results for the three months ended March 31, 2021. The Company will host a conference call and webcast at 08:30 ET today.
Recent Clinical & Scientific Developments
- Histology Results from approximately one-third of the study population (~ 50 subjects) of the open label part of the ARMOR Phase 3 study with higher exposure of Aramchol are expected to be available in Q4 2021.
- The National Medical Products Administration (NMPA) has granted approval for the Investigational New Drug (IND) application for the ARMOR Phase 3 study of Aramchol for the treatment of NASH & fibrosis in China.
- Submitted to the FDA the results of the Aramchol meglumine Phase I study with a view to introducing Aramchol meglumine into the double-blind placebo controlled registrational part of the ARMOR Phase 3 study. Galmed is expecting to receive guidance from the FDA in Q3 2021 and initiate the double-blind part of the ARMOR Phase 3 study by the end of Q1 2022.
- Completed single administrated doses from 10mg to 180mg in first in human Phase I trial of Amilo-5-Mer. Following excellent safety and proportional PK, single dosing ascended to 360mg. Topline data is expected in second half of 2021 and a Phase 1b proof of concept study is planned for Q4 2021.
Financial Summary – First Quarter 2021 vs. First Quarter 2020:
- During February 2021, Galmed raised approximately $18.4 million in an underwritten public offering and from its at-the-market equity facility.
- Cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities totaled $58.9 million as of March 31, 2021, compared to $50.9 million at December 31, 2020.
- Net loss amounted to $8.9 million, or $0.38 per share, for the three months ended March 31, 2021, compared to a net loss of $6.1 million, or $0.29 per share, for the three months ended March 31, 2020.
- Research and development expenses amounted to approximately $7.4 million for the three months ended March 31, 2021, compared to approximately $5.6 million for the three months ended March 31, 2020. The increase resulted primarily from an increase in drug development expenses in connection with the manufacturing of Aramchol API to support the ARMOR Study and the development of Aramchol meglumine.
- General and administrative expenses amounted to approximately $1.7 million for the three months ended March 31, 2021, compared to approximately $0.9 million for the three months ended March 31, 2020. The increase in general and administrative expenses for the three months ended March 31, 2021 resulted primarily from an increase in salaries and benefits, and as well from an increase in the cost of our D&O insurance policy premium.
- Financial income, net amounted to $0.2 million for the three months ended March 31, 2021, compared to financial income, net of $0.4 million for the three months ended March 31, 2020.
Conference Call & Webcast:
Thursday May 13, 2021, 8:30 AM ET
Toll Free: 1-877-425-9470
Israel Toll Free: 1 809 406 247
Conference ID: 13719139
Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Replay Pin Number: 13719139
Replay Start: Thursday May 13, 2021, 11:30 AM ET
Replay Expiry: Thursday May 27, 2021, 11:59 PM ET
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.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide and recently initiated a first in human study.