GLMD
NASDAQ · Healthcare · Biotechnology · IL
Next report
Analyst consensus
- Next report date
- Nov 25, 2026
- EPS estimate
- -$3.12
- Revenue estimate
- —
Latest reported
- Last report date
- Sep 2, 2026
- EPS actual
- -$2.86
- EPS estimate
- -$3.12
- Revenue actual
- —
- Revenue estimate
- —
Track record
Trailing twelve quarters
- EPS beats (12Q)
- 4
- EPS misses (12Q)
- 5
- EPS in line (12Q)
- 0
- Avg surprise (4Q)
- -34.5%
- Revenue beats (12Q)
- 0
Q4 FY2021 · May 2, 2022
AI summary of management’s prepared remarks and analyst Q&A · For informational purposes only, not investment advice
Management highlights
- 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.
Guidance
- 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.
Segment performance
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.
Risks & headwinds
- 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.
Analyst Q&A
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.
Reported results against consensus at the time of each report · Surprise is computed from the estimate on record · Data as of Nov 25, 2026