Galmed Pharmaceuticals Ltd. Q4 FY2021 earnings call

• On April 28, Galmed published interim results from the open label part of the ARMOR Phase 3 study, showing Aramchol supports anti-fibrotic effects and favorable safety profile. Results of post baseline biopsies from 46 subjects with NASH and F1-3 showed fibrosis improvement at 24 and 48 weeks, with AI analysis showing statistically significant reduction. - Delay in initiation of the double blind, placebo control registrational part of the Phase 3 study to second half of 2023 due to uncertainties in NASH study endpoints, reliance on biopsies, and regulatory/study design considerations. - January 2022: USPTO granted new patents related to Aramchol for fibrosis and gut microbiota modulation, extending IP protection until 2038. - Amilo-5MER: Positive Phase 1 results in healthy volunteers; planning proof of concept studies, initially for IBD, with potential for other inflammatory indications. - New CFO Doron Cohen joined with over 25 years of global financial markets experience.

Net loss for the three and 12-months ended December 31, 2021 was $7.5 million and $32.5 million respectively, compared to $10.3 million and $28.8 million in 2020. Research and development expenses for the three and 12 months ended 2021 totaled $6.3 million and $27.2 million, vs. $9 million and $26.1 million in 2020. G&A expenses for the three and 12-months ended 2021 were $1.2 million and $5.7 million vs. $1.3 million and $4.1 million in 2020. Cash balance as of December 31, 2021 was $34.9 million vs. $51 million in 2020.

• Initiation of the double blind, placebo control part of the Phase 3 study with Aramchol meglumine moved to second half of 2023. - Intend to provide more details on Amilo-5MER proof of concept studies in the next few months.

• Uncertainties in NASH study endpoints, including dependence on biopsies as primary surrogate, lack of validated non-invasive biomarkers, and high screen failure rates. - Competitive landscape for Amilo-5MER development, including need to establish an edge in the market.

Q: Asked about histology data, specifically 24-week vs 48-week cohorts and 72-week biopsies.

A: Most patients came from 48-week, combined 48 and 72, ~5 patients from 72. Numbers too small to draw conclusions from 72-week.

Q: Question on 2023 guidance for Phase 3 study, factors out of control.

A: Field developing positively, waiting for biomarkers, plan to meet with FDA, shared unique biopsy reading data.

Q: How recent data correlates with Aramchol meglumine profile.

A: Aramchol meglumine has same exposure potential, advantage in compliance, cost, etc., no difference in data between formulations.

Q: On Amilo-5MER proof of concept plans.

A: Considering combination treatments, inter colonic oral formulation for IBD, assessing competitive landscape.

Q: On clinical value of different methodologies, conversation with KOLs/FDA.

A: Methodologies important for sensitivity, consulting KOLs, AI used recommended by KOLs, data valuable for NASH companies.

Q: On moving away from histology, discussions with FDA.

A: Trying to move from categorical to sequential method, combination with AI support, FDA allowing AI use, working towards better study design.