Galmed Pharmaceuticals(GLMD) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q3 2020, the company reported a net loss of $6.9 million or $0.32 per share, compared to a net loss of $4.5 million or $0.21 per share in Q3 2019 [12] - Research and Development expenses increased to $6.5 million in Q3 2020 from $4.1 million in Q3 2019, primarily due to higher clinical trial expenses related to ongoing ARMOR trials [12] - General and Administrative expenses rose to $1.5 million in Q3 2020 from $1 million in the same period in 2019, mainly due to increased D&O insurance policy premiums [13] - The cash balance as of September 30, 2020, was $58.7 million, down from $75.6 million as of December 31, 2019 [14] Business Line Data and Key Metrics Changes - The company is focusing on the Aramchol meglumine program, with expectations to report first-in-human PK data next month [5] - A collaboration with Gannex Pharma was announced to develop a combination therapy that includes ASC41 and Aramchol, aimed at improving liver fat reduction and blood lipid profiles [5][6] - The ARMOR Phase 3 study has opened sites in 10 additional countries, but recruitment has been hampered by the COVID-19 pandemic [8][9] Market Data and Key Metrics Changes - The company is assessing recruitment plans due to the impact of COVID-19, which has slowed down patient enrollment in key markets like the US and Europe [22][44] - Brazil is expected to start recruiting patients as early as January, which could help meet enrollment targets [24] Company Strategy and Development Direction - The company aims to maximize the clinical efficacy of Aramchol through collaborations and product optimizations, including a focus on microbiome-based therapies [6][31] - The strategy includes enhancing the response rates to Aramchol and exploring the microbiome as a potential biomarker for treatment efficacy [31][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress of the Pfizer vaccine and its potential impact on business operations [5] - The ongoing COVID-19 pandemic presents significant uncertainty, affecting recruitment timelines and operational activities [2][9] - The company plans to provide updates on recruitment and clinical data by mid-December [9][44] Other Important Information - The first virtual Analyst Day is scheduled for January 26, where clinical data from the ARMOR meglumine and Amilo-5MER programs will be presented [10][54] - The company is collecting microbiome samples from various patient groups to enhance the understanding of treatment responses [34][35] Q&A Session Summary Question: Details on Gannex TR beta licensed - Management refrained from disclosing specific information about ongoing studies but highlighted the specificity and potency of the licensed molecule [17][18] Question: Geographic distribution of ARMOR study enrollment - Management indicated it is too early to determine if the anticipated geographic distribution of enrollment will change due to the pandemic [21][22] Question: Collaboration with MyBiotics and microbiome role in NASH - Management discussed the potential of microbiome changes to enhance Aramchol efficacy and the role of precision medicine in identifying responders [28][31][37] Question: Update on recruitment plan and timelines - Management acknowledged the need for a new recruitment plan and indicated that updates would be provided in December [41][44] Question: Bioequivalence and dosing for Aramchol meglumine - Management confirmed that data on single and multiple dosing will be presented in December, which is crucial for regulatory discussions [45][48]