Galmed Pharmaceuticals(US:GLMD)2021-05-13 22:58Financial Data and Key Metrics Changes - For Q1 2021, the company reported a net loss of $8.9 million or $0.38 per share, compared to a net loss of $6.1 million or $0.29 per share for Q1 2020, indicating a deterioration in financial performance [15] - Research and development expenses increased to $7.4 million in Q1 2021 from $5.6 million in Q1 2020, primarily due to higher drug development costs associated with Aramchol meglumine [15] - General and administrative expenses rose to $1.7 million in Q1 2021 from $0.9 million in Q1 2020 [16] - The cash balance as of March 31, 2021, was $58.9 million, up from $51 million on December 31, 2020, reflecting a positive cash flow from a public offering [16] Business Line Data and Key Metrics Changes - The ARMOR study for Aramchol is progressing, with results from approximately one-third of the study population expected in Q4 2021 [7] - The IND approval for Aramchol in China is seen as a significant milestone, potentially accelerating patient randomization in the ARMOR study [8] - Amilo-5MER has completed its first-in-human Phase 1 trial, with topline data expected in the second half of 2021 [12] Market Data and Key Metrics Changes - The company is focusing on the U.S. and China markets for the ARMOR study, with plans to initiate enrollment in China as soon as practical [9] - The company is also exploring additional indications for Amilo-5MER, targeting chronic inflammatory diseases beyond ulcerative colitis [14] Company Strategy and Development Direction - The company aims to position Aramchol as a leading therapeutic candidate for NASH and fibrosis, particularly in emerging markets like China [8] - The development of Amilo-5MER is being pursued in two formulations to target different patient populations and indications [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to gather comprehensive data for the first 50 patients in the ARMOR study despite challenges posed by the COVID-19 pandemic [32] - The company anticipates reinitiating the double-blind part of the ARMOR study by Q1 2022, focusing on areas less affected by COVID-19 [34] Other Important Information - The company is awaiting written feedback from the FDA regarding the Aramchol meglumine development plan, with expectations for a response in June 2021 [22] Q&A Session Summary Question: Insights on the single ascending dose study for Amilo-5MER - Management clarified that the decision to double the highest dose was based on pharmacokinetics and safety data [20] Question: Clarification on FDA interactions regarding Aramchol meglumine - Management confirmed they are awaiting written feedback from the FDA and have submitted the necessary documentation [22] Question: Details on histology data from patients in the ARMOR study - Management indicated that the majority of patients will be F2, H3, with approximately 25 patients expected to undergo 48 and 72 weeks of treatment [24] Question: Plans for the new Aramchol meglumine formulation in China - Management stated that the existing protocol for the ARMOR study has been approved, and they are working on amendments for the new formulation [26] Question: Confidence in data collection amid the pandemic - Management reassured that they have selected U.S. sites less affected by COVID-19 for patient recruitment [32] Question: Target patient populations for Amilo-5MER - Management emphasized the focus on mild to moderate ulcerative colitis patients, highlighting the safety and efficacy profile of Amilo-5MER [36]