Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q3 2019 Earnings Conference Call - Final Transcript
Nov 06, 2019 • 08:30 am ET
Good day, and welcome to Galmed Conference Call to discuss financial results for third quarter of 2019. Today's conference is being recorded.
Before we begin, please note that we will be making certain forward-looking statements on today's call, including those regarding financial results, statements and forecasts regarding anticipated timelines and expectations with respect to our regulatory and clinical development programs, as well as other statements that relate to future events.
These statements are based on the beliefs and expectations of management as of today, and actual results, trends, timelines and projections relating to our financial position and projected development programs and pipeline could differ materially. We urge all investors to read carefully the risks and uncertainties disclosed in our filings with the SEC, including, without limitation, the risks under heading Risk Factors described in our Annual Report on Form 20-F filed with SEC and the risks and uncertainties included in the Form 6-K filed with the SEC earlier today. Galmed assumes no obligation to update any forward-looking statements or information, which speaks as of their respective dates only.
I would now like to turn the call over to Allen Baharaff, President and Chief Executive Officer. Allen, please go ahead.
Thank you, Steve. Good morning, and thank you for joining us on today's conference call. I'm pleased to be here today with our Chief Scientific Officer, Dr. Liat Hayardeny, our Chief Medical Officer, Dr. Tali Gorfine, and our Chief Financial Officer, Yohai Stenzler, to provide you with an update on our clinical development program, as well as report to you our financial results for the third quarter of 2019. As always, we will be happy to take any questions you may have at the conclusion of our prepared remarks.
During the last quarter, we announced initiation of our Phase 3/4 ARMOR registrational study. ARMOR is a global study that will be conducted in 15 [Phonetic] countries, including the US, Europe, Latin America and Asia in approximately 185 sites. A total of 2,000 subjects will be randomized to receive Aramchol 300 milligram twice daily or matching placebo in a 2:1 ratio.
Based on our recent PK dosing study, this dosing regimen is expected to result in higher exposure and has the potential for greater efficacy. All subjects enrolled are overweight or obese and have pre-diabetes or type II diabetes. This targeted homogeneous population was selected taking into consideration that type II diabetes is an important risk factor for NASH and is therefore considered a population with an urgent unmet need.
The study consists of two parts. The first part, histology based, includes 1,200 subjects treated for 52 weeks and is powered to meet both key endpoints, NASH resolution and no worsening of liver fibrosis; and fibrosis improvement without NASH worsening. Meeting either of these endpoints is expected to suffice for the study to succeed at the end of part 1. These data will serve as the basis for the submission of a marketing authorization application under regulatory provisions of accelerated/conditional approval. We look