Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q1 2019 Earnings Conference Call Transcript

May 07, 2019 • 08:30 am ET

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Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) Q1 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, and welcome to the Galmed Conference Call to Discuss Financial Results for the First 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 risk under the heading Risk Factors described in our Annual Report on Form 20-F filed with the 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 speak 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.

Executive
Allen Baharaff

Thank you, Miscynth. 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 on our financial results for the first quarter of 2019. As always, we will be happy to take any question you may have at the conclusion of our prepared remarks.

On April 9, we announced that we completed our end of Phase 2 meeting with the Food and Drug Administration, FDA, and reached general agreement on key aspects of the Phase 3/4 development and registration plan for our pivotal registration study ARMOR. ARMOR is a Phase 3/4 multinational, multicenter, double-blind, placebo-controlled clinical study to evaluate the efficacy, safety and tolerability of Aramchol in subjects with NASH and fibrosis. General agreement has been reached with the FDA on key aspects of the ARMOR Phase 3/4 study, including patient population, study endpoints, study dose and treatment duration. We plan on submitting the study protocol of ARMOR to the FDA during this quarter, with study commencement expected in the third quarter of 2019.

In summary, the design of ARMOR -- of the ARMOR study is in line with Aramchol unique mechanism of action, which demonstrate an effect on both NASH resolution and fibrosis improvement and is based on the ARREST results and the FDA recommendations. Under the current trial design, we are submitting to the FDA ARMOR will be -- will evaluate the safety and efficacy of Aramchol in approximately 2,000 patients on a dosage of twice daily 300 milligram treatment compared to placebo in a 2:1 randomization.

The study's design