Galmed Pharmaceuticals(GLMD) - 2020 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q2 2020, the company reported a net loss of $5.5 million or $0.26 per share, compared to a net loss of $4.2 million or $0.20 per share in Q2 2019 [20] - Research and development expenses increased to $5 million in Q2 2020 from $3.5 million in Q2 2019, primarily due to increased CMC and formulation expenses related to Aramchol [20] - General and administrative expenses decreased to $0.8 million in Q2 2020 from $1.2 million in Q2 2019, attributed to lower professional services and investor relations expenses [21] - Cash balance as of June 30, 2020, was $63.5 million, down from $75.6 million as of December 31, 2019 [23] Business Line Data and Key Metrics Changes - The ARMOR Phase III study for Aramchol faced recruitment delays due to COVID-19 but began to see positive signs in patient screening starting in June 2020 [9][10] - The company is developing Aramchol meglumine, which aims to provide long-term patent protection and improved efficacy compared to Aramchol free acid [11] - Amilo-5MER, a new clinical program, is ready for Phase I trials, targeting chronic inflammation and potentially severe COVID-19 cases [16][15] Market Data and Key Metrics Changes - The ARMOR study is currently active in multiple countries including the USA, Canada, and several European and Asian nations, with plans to expand to additional countries [9][53] - The company is preparing to submit a full IND in China based on a pre-IND meeting, with expectations to start activities there in early 2021 [53] Company Strategy and Development Direction - The company is focused on advancing its clinical programs while navigating the challenges posed by the COVID-19 pandemic [6][10] - There is an emphasis on collaboration and potential licensing opportunities to expand the reach of its products without straining financial resources [42] - The company plans to conduct a bioequivalence study for Aramchol meglumine in Q3 2020, with a full regulatory study planned for Q2 2021 [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the recruitment pace for the ARMOR study, maintaining guidance for completion of recruitment in Q4 2021 and top-line results in the second half of 2023 [10] - The ongoing impact of COVID-19 remains a significant uncertainty, affecting timelines and operational capacity [3][10] - Management highlighted the importance of Serum Amyloid A as a biomarker for various inflammatory diseases, including IBD and COVID-19, indicating a strategic focus on these areas [40][56] Other Important Information - The company plans to attend several investor conferences and hold a virtual Analyst Day to provide updates on its clinical programs [16][18] - Amilo-5MER has shown promise in reducing chronic inflammation in animal models and is being investigated for its effects on COVID-19 patients [15][14] Q&A Session Summary Question: Discussion on the bioequivalence study for Aramchol meglumine - The study will start with healthy volunteers and will test both once-daily and twice-daily doses, with a full regulatory bioequivalence study planned for Q2 2021 [26][29] Question: Discovery of Amilo-5MER peptide - The peptide was isolated from joint inflammatory cells, identifying a specific sequence in human CD44 variant responsible for higher inflammation [32][34] Question: Potential for Amilo-5MER in IBD and other indications - The company is starting with IBD due to clear biomarkers and is open to exploring other indications as the compound advances [40][42] Question: Half-life and dosing considerations for Amilo-5MER - The anticipated half-life is approximately 1.5 hours, with subcutaneous administration planned for the Phase I study [36][45] Question: Timeline for utilizing the salt formulation in the ARMOR study - The salt formulation will be ready for use in the ARMOR study after the bioequivalence study, expected to begin in Q2 2021 [61][66]