Galmed Pharmaceuticals(US:GLMD)2019-05-07 17:01Financial Data and Key Metrics Changes - For Q1 2019, the company reported a net loss of $3.5 million or $0.17 per share, compared to a net loss of $2.5 million or $0.17 per share in Q1 2018 [19] - Research and development expenses increased to $3.3 million in Q1 2019 from $1.9 million in Q1 2018, primarily due to manufacturing costs for Aramchol in preparation for the ARMOR study [19] - General and administrative expenses decreased to $0.8 million in Q1 2019 from $0.9 million in Q1 2018 [20] - Financial income rose to $0.5 million in Q1 2019 from $0.1 million in Q1 2018, attributed to interest income from financial instruments [21] - Cash balance as of March 31, 2019, was $86.6 million, down from $90.2 million on December 31, 2018 [21] Business Line Data and Key Metrics Changes - The ARMOR study is a Phase 3/4 multinational clinical trial aimed at evaluating the efficacy, safety, and tolerability of Aramchol in patients with NASH and fibrosis [8][10] - The study will involve approximately 2,000 patients, with a dosage of twice daily 300 mg compared to placebo in a 2:1 randomization [10] Market Data and Key Metrics Changes - The ARMOR study is designed to be a global study, including participants from the U.S., Europe, Latin America, and Asia, which is expected to facilitate faster registration across continents [15] Company Strategy and Development Direction - The company aims to submit the ARMOR study protocol to the FDA during the current quarter, with study commencement expected in Q3 2019 [8] - The focus is on completing preparations for the ARMOR study and ensuring efficient randomization within 18 months of commencement [17] - The company is also exploring combination studies with other treatments, which are considered a top priority [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ARMOR study's design and its alignment with FDA recommendations, anticipating positive results that could lead to accelerated conditional approval [12][17] - The company is committed to maintaining a robust safety profile for Aramchol while increasing exposure to enhance efficacy [46] Other Important Information - The estimated budget for the ARMOR study is around $65 million, with a total projected cost of approximately $110 million for the entire program [26][61] - The company plans to report results from the first part of the ARMOR study in Q4 2022 [17] Q&A Session Summary Question: Reasons for enrolling 1,200 patients in the interim Aramchol study - Management stated that the larger enrollment is to ensure robust data for both endpoints, with the study powered to meet both [25] Question: Cost of Phase 3 study - The estimated budget remains around $65 million, accounting for both high-cost and low-cost recruiting countries [26] Question: Per-patient costs for NASH trials in the U.S. versus ex-U.S. - Costs in the U.S. range from $25,000 to $50,000 per patient, while costs in Europe are about $12,000 to $15,000, and in Latin America, less than $10,000 [35] Question: Timeline for turning on Phase 3 sites - The U.S. is expected to have the first sites open, with the study anticipated to start in Q3 2019 [37] Question: Safety considerations for increased exposure in Phase 3 - Management indicated that splitting the dose reduces side effects while maintaining efficacy, with extensive monitoring planned for the ARMOR study [44][47] Question: Interim efficacy or safety analysis before top line readout - There will be no interim efficacy analysis, but routine safety reviews will be conducted [57][59] Question: Cost estimate for the entire ARMOR program - The total cost for the ARMOR program is estimated at approximately $110 million, with the first part budgeted for $65 million [61]