Galmed Pharmaceuticals Ltd. Q1 FY2021 earnings call

Key Points

• Allen Baharaff discussed Globe's Global Phase 3 ARMOR study, with open label part approved in various regions and expected Q4 2021 liver biopsy results. Aramchol received IND approval in China.
• Yohai Stenzler provided financial results for Q1 2021 and referred to Form 6-K for more details.

No detailed product segment revenue breakdown provided. Clinical program highlights include Globe's Global Phase 3 ARMOR study with open label part approved in multiple regions, expected Q4 2021 liver biopsy results for ~50 subjects in the study, Aramchol IND approval in China as a milestone, and details on Aramchol meglumine.

Forward-Looking Statements

• Expect results on Aramchol efficacy in fibrosis via liver biopsy in Q4 2021.
• ARMOR study's double-blind placebo control registration expected to initiate by the end of Q1 2022.

Risks

• COVID-19 affecting study timelines, with Europe experiencing delays but US sites selected to be less impacted by COVID-19.

Q: Can you just talk about what you're seeing in the single ascending dose study for the Amilo-5MER?

A: Liat Hayardeny mentioned PK and safety related to Serum Amyloid A regulation, noting healthy volunteers don't have elevated Serum Amyloid A so not relevant for downregulation in that context.

Q: Just regarding Aramchol meglumine, can you just clarify if you've had a type C meeting with FDA and the feedback you're expecting?

A: Liat Hayardeny said they are waiting for a written response, applied for a meeting, and expect a written response from the FDA in June 2021.

Q: Off the histology data from patients 2021, how many patients will be what's the percentage of patients that have been treated for 24 weeks or 48 weeks or 72?

A: Yohai Stenzler talked about majority of patients being F2, H3, with about 25 patients on 48 and 72 weeks on biopsy front and about 25 on 24 week.

Q: In light of the ongoing pandemic, can you talk about the team's confidence in having a comprehensive data set for the first 50 patients in histology results to Aramchol?

A: Yohai Stenzler mentioned US sites selected less affected by COVID-19, Europe had delays but majority of patients expected from US, timelines confirmed as on track.

Q: Given the complexity of the IBD markets, what specific signals are you looking for with Amilo-5MER?

A: Liat Hayardeny talked about targeting colitis patients, mild to moderate, and superior safety and tolerability of Amilo-5MER compared to existing compounds in the market