Galmed Pharmaceuticals Ltd. Q3 FY2020 earnings call

• Anticipates reporting first-in-human PK data from Aramchol meglumine program next month.
• Entered research agreement with Gannex Pharma for combination therapy of ASC41 and Aramchol.
• Collaborated with MyBiotics to maximize Aramchol clinical efficacy, including microbiome collaboration to identify biomarkers and enhance efficacy.
• Aramchol program optimizations: dose optimization (300 mg BID increased exposure by 53%), product optimization (Aramchol meglumine with higher scalability), and treatment duration optimization.
• Ongoing clinical studies collecting microbiome samples from healthy volunteers, NASH patients, and Aramchol-treated patients.

For the third quarter of 2020, Galmed's net loss totaled $6.9 million or $0.32 per share, compared with a net loss of $4.5 million or $0.21 per share for the corresponding quarter in 2019. Research and Development expenses were $6.5 million in Q3 2020 vs $4.1 million in Q3 2019, primarily due to increased clinical trial expenses for ARMOR trials. General and administrative expenses were $1.5 million in Q3 2020 vs $1 million in Q3 2019, mainly from higher DMO insurance premium. Net financial income was $0.7 million in Q3 2020 vs $0.5 million in Q3 2019, driven by realized gains from prior periods.

• Expecting first-in-human PK data from Aramchol meglumine next month.
• Multiple dosing of Aramchol meglumine to start as early as mid-December.
• Amilo-5MER pipeline product entering first-in-human study early Q1.
• Plan to switch patients to Aramchol meglumine and advance timelines for clinical data.

• COVID-19 pandemic impact on clinical trial recruitment, particularly in US and Europe where recruitment has slowed due to second wave.
• Uncertainty regarding the duration and severity of COVID-19 and its effect on Galmed's business and operations.

Q: Elaborate on Gannex TR beta's selectivity and potency for TR beta compared to other clinical stage TR betas.

A: Allen Baharaff mentioned they can't disclose ongoing Gannex studies, but Dr. Liat Hayardeny noted ASC41 is more specific, can be given at lower doses with higher specificity, and has good safety profile compared to Madrigal's steroid-based compound.

Q: Regarding ARMOR study enrollment across globe and potential update to enrollment guidance.

A: Allen Baharaff stated US and Europe recruitment slowed due to COVID-19 second wave, but Brazil may start recruiting patients in January. They're balancing recruitment push with patient benefits and will update guidance in December with more details on Aramchol meglumine data and recruitment plan.

Q: Details on MyBiotics collaboration and enhancing efficacy of non-responders.

A: Dr. Liat Hayardeny explained they're looking to identify microbiome differences between Aramchol responders and non-responders, aim to change non-responders' microbiome to match responders' to enhance Aramchol efficacy, with microbiome samples already collected in ongoing studies and incorporated into Aramchol meglumine multiple dosing starting mid-December