Galmed Pharmaceuticals Ltd. Q4 FY2020 earnings call

• Hosted a KOL Symposium and Pipeline Update focusing on Aramchol (Phase 3 for NASH and fibrosis) and Amilo-5MER (chronic inflammatory disorders).
• Announced the open-label part of the ARMOR Phase 3 registrational study for Aramchol, enrolling ~150 patients to evaluate treatment response, pharmacokinetics, safety, and explore histological outcomes and non-invasive tests.
• R&D expenses increased due to clinical trial and drug development activities related to ARMOR and Aramchol manufacturing.
• Cash position as of December 31, 2020, was strong with additional proceeds from recent offerings.

For the three and 12 months ended December 31, 2020, the net loss was $10.3 million and $28.8 million respectively, compared to $8.3 million and $20.5 million in 2019. Loss per share was $0.48 and $1.35 for the respective periods. Research and development expenses for the three and 12 months ended December 31, 2020, were $9 million and $26.1 million, an increase from $7.4 million and $18.2 million in 2019, primarily due to clinical trial expenses for the ARMOR study and drug development for Aramchol manufacturing. General and administrative expenses were consistent with 2019. Cash balance as of December 31, 2020, totaled $51 million, not including $17.5 million in net proceeds from February offerings.

• Expect to reinitiate the double-blind part of the ARMOR study in Q1 2022, enroll 1,000 patients in 18 months (Q3 2023), with data readout around Q2 2024.
• Amilo-5MER Phase 1b study to start in the second half of 2021, focusing on biomarker evaluation in a 20-patient study.
• ARMOR program R&D spend is south of $100 million, dependent on competitive landscape and patient recruitment timelines.

Q: Remind us of the timeline for switching in the ARMOR study to meglumine, enrollment, and data readout?

A: Expect to reinitiate double-blind part of ARMOR study in Q1 2022, enroll 1,000 patients in 18 months (Q3 2023), data readout around Q2 2024.

Q: Describe potential chronic inflammatory conditions for Amilo-5MER and pace of R&D expense increase?

A: Relevant for RA and COVID-19; Phase 1b study starts in second half of 2021; R&D spend for ARMOR south of $100 million depending on factors.

Q: Thoughts on incorporating F4 patients in Phase 3 design and hepatic impairment studies for Aramchol?

A: Not recruiting F4 patients; hepatic impairment studies for Aramchol progressed, with some delay due to COVID-19 but accelerating.

Q: Timeline for ARMOR data presentation and patent status of Aramchol meglumine?

A: May miss AASLD deadline but will communicate data as available; Aramchol meglumine patent expires 2034, composition of matter patent pending.

Q: Confidence in collecting key data sets for 50 patients in open-label study despite pandemic?

A: High confidence due to established site collaboration and surge in patient recruitment post-COVID restrictions lift