Galmed Pharmaceuticals Ltd. Q2 FY2021 earnings call

• FDA agreed to use Aramchol meglumine in the randomized double-blind placebo-controlled part of the Phase 3 ARMOR study, allowing once-daily regimen, potential cost savings, and extended patent until 2034.
• Open label part of ARMOR Phase 3 study: Results from ~50 subjects expected in Q4 2021.
• Amilo-5MER: Phase 1 clinical trial dosing completed, topline data expected later in Q2 2021.
• Planning to attend three investor conferences: Canaccord Annual Growth Conference, HC Wainwright Annual Global Investor Conference, and Cantor Global Healthcare Conference.

For the second quarter of 2021, Galmed's net loss totaled $8.4 million or $0.33 per share, compared with a net loss of $5.5 million or $0.26 per share for the second quarter in 2020. Research and development expenses were $7 million in Q2 2021, up from $5 million in Q2 2020, primarily due to increased clinical trial expenses for the ARMOR trial. General and administrative expenses were $1.4 million in Q2 2021, up from $0.8 million in Q2 2020, mainly due to higher D&O insurance premiums and salaries/benefits. Cash balance as of June 30, 2021 was $51.2 million, compared to $51 million on December 31, 2020.

• Transition to Aramchol meglumine benefits patients with improved convenience and potential cost savings.
• Clinical pharmacology studies timelines dependent on formulation, aiming to start next trial by end of Q1 2022.
• Cohorts from open label study expected in Q2 2022.

• Uncertainties in clinical development timelines and outcomes; actual results may differ from forward-looking statements.

Q: Could you clarify the patient groups in the open label part of the ARMOR Phase 3 study?

A: The first 50 patients in the open label part are blinded and a mix of populations for 24, 48, and 72 week biopsies.

Q: Could you provide details on planned clinical pharmacology studies and timelines?

A: Three studies proposed: dose range finding, food effects, and bioequivalence; timelines dependent on formulation, aiming to start next trial by end of Q1 2022.

Q: Could you talk about the cadence of additional cohorts from the open label study?

A: Next cohort of 100 patients expected in Q2 2022.

Q: Could you discuss Amilo-5MER formulations?

A: Working on oral local formulation for ulcerative colitis and injectable localized formulation for other indications like RA