Galmed Pharmaceuticals(US:GLMD)2021-11-08 20:24Financial Data and Key Metrics Changes - For Q3 2021, the company reported a net loss of $7.7 million or $0.31 per share, compared to a net loss of $6.9 million or $0.32 per share in Q3 2020 [61] - Research and development expenses remained at $6.5 million for Q3 2021, consistent with the same quarter in 2020 [61] - General and administrative expenses increased to $1.3 million from $1.1 million in the corresponding period in 2020 [61] - Cash balance as of September 30, 2021, totaled $42 million, down from $51 million on December 31, 2020 [61] Business Line Data and Key Metrics Changes - The ARMOR study's open-label part demonstrated a 60% response rate in fibrosis improvement among patients treated with Aramchol, significantly higher than historical placebo response rates [21][14] - The study included a rigorous pathology reading process involving three independent pathologists to ensure accuracy in assessing fibrosis [10] Market Data and Key Metrics Changes - The company is focusing on the NASH (Non-Alcoholic Steatohepatitis) market, which has seen limited successful treatments for fibrosis, positioning Aramchol as a potential leader in this space [44] - The Phase 3 ARMOR study is expected to provide further insights into the efficacy of Aramchol, with discussions ongoing with the FDA regarding potential conditional marketing authorization [21][59] Company Strategy and Development Direction - The company aims to optimize its NASH program by focusing on fibrosis improvement as the primary endpoint and increasing the effect size through higher dosing of Aramchol [58] - Plans to initiate the double-blind portion of the ARMOR study in the second half of 2022, with expectations for a shorter trial duration based on recent data [64] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results from the ARMOR study, viewing them as a potential game changer for the treatment of liver fibrosis [57] - The company acknowledges skepticism in the NASH space but remains committed to demonstrating the efficacy of Aramchol through robust clinical data [57] Other Important Information - The preliminary results from the ARMOR study have been accepted for presentation at the American Association for the Study of Liver Diseases meeting [11] - The company is preparing for a bioequivalence study of a new Aramchol formulation, which is crucial for the upcoming double-blind study [65] Q&A Session Summary Question: Are any patients receiving other therapies? - Patients are allowed to be on other medications if they have been on them for an extended period before the initial biopsy [25] Question: When should we expect the next set of biopsy data from the ARCON cohort? - The next data update is expected when the first 50 patients reach the end-of-treatment biopsy, likely around the EASL conference next year [29] Question: How do you view the results on fibrosis improvement compared to other data sets? - The results show a higher level of response compared to historical placebo rates, positioning Aramchol favorably against other treatments in the NASH space [44] Question: What is the expected timeline for the double-blind portion of the ARMOR study? - Enrollment for the double-blind portion is planned to reinitiate in the second half of 2022 [64] Question: Is there any weight loss induced by the drug? - Currently, there is no clear effect on weight loss; the drug appears to be weight neutral [52]