Galmed Pharmaceuticals Ltd. Q1 FY2020 earnings call

• Preclinical PK data on Aramchol meglumine compared to Aramchol free acid showed bioequivalence with reduced variability, higher steady-state AUC, and a three-fold reduction in coefficient of variation. - Aramchol meglumine is a new chemical entity eligible for patent protection until 2034, with patents granted in 37 European territories, Japan, Australia, China, and Canada, and ongoing discussions in the US, India, etc. - Impact of COVID-19 led to temporary halt of screening new patients for ARMOR study, with plans to resume in Q2 in green states and full recruitment by Q4 2021. - Cost mitigation measures included minimizing non-mandatory clinical expenses, adjusting clinical staff pay, and reducing board cash fees by 50% for H1 2020.

For the first quarter of 2020, Galmed's net loss totaled $6.1 million or $0.29 per share, compared with a net loss of $3.5 million or $0.17 per share for the corresponding quarter in 2019. Research and Development expenses were $5.6 million in Q1 2020 compared to $3.3 million in Q1 2019, primarily due to increased clinical trial expenses for the ARMOR study. General and administrative expenses were $0.9 million in Q1 2020 compared to $0.8 million in Q1 2019, driven by increased non-cash stock-based compensation. Cash balance as of March 31, 2020, was $69 million, down from $75.6 million on December 31, 2019.

• Revised completion of recruitment for ARMOR NASH Phase 3 study from Q2 2021 to Q4 2021. - Topline results for the first part of the study moved from Q4 2022 to second-half of 2023. - Cost burn reduced due to delays in patient enrollment, with clinical expenses directly correlated to patient enrollment.

• Uncertainty regarding the duration and severity of COVID-19 pandemic impacting trial timelines and operations. - Ongoing patent discussions in certain jurisdictions, though confident in patentability but acknowledging potential delays in some regions.

Q: Can you provide color on safety profile of meglumine vs Aramchol and patentability in US?

A: Refer to tafamidis case where meglumine's toxicology is established; confident in patentability with 37 European territories, etc. approved.

Q: How many patients dosed with Aramchol and if data from Aramchol and meglumine will be combined?

A: Not disclosing patient count; will disclose when reaching predefined milestones.

Q: Chance of restarting trial with meglumine?

A: Tafamidis precedent shows changing formulation during study is possible with FDA acceptance.

Q: Concerns about meglumine exacerbating hypertension?

A: No concerns, no signal of hypertension with Aramchol.

Q: Cash runway estimate?

A: Burn rate about $1.5M per quarter, additional CMC costs budgeted.