Galmed Pharmaceuticals Ltd.

Galmed reported a net loss of $7.5 million for Q4 2021 and $32.5 million for full-year 2021, compared with losses of $10.3 million and $28.8 million in the prior-year periods. Loss per share was $0.13 for Q4 2021 and $1.32 for full-year 2021, versus $0.48 and $1.35 in 2020. Research and development expense was $6.3 million in Q4 and $27.2 million for the year, while general and administrative expense was $1.2 million in Q4 and $5.7 million for the year. Cash, cash equivalents, restricted cash and marketable securities totaled $34.9 million at December 31, 2021, versus $51 million a year earlier. On the clinical side, management said week 48 fibrosis improvement was identified in 40% of patients by NASH CRN, 65% by paired reading, and 100% by AI; AI showed statistically significant fibrosis reduction at week 24 (P=0.017) and week 48 (P<0.0001). The company did not provide revenue guidance; instead, it said the registrational double-blind part of ARMOR is now planned for the second half of 2023, subject to open-label results, sufficient funding, and clarification of the regulatory approval process for NASH drugs.

Allen Baharaff’s tone was confident about the science but cautious on timing. He emphasized that the open-label ARMOR data support Aramchol’s anti-fibrotic effect and that the company believes AI and paired-reading approaches may better capture fibrosis change than traditional categorical scoring. At the same time, he said the registrational study is too risky to start now because the primary endpoint and broader NASH development framework remain unsettled.

Yohai Stenzler focused on the reported 2021 financials and balance sheet. He cited a Q4 net loss of $7.5 million, full-year net loss of $32.5 million, R&D expense of $27.2 million for the year, G&A expense of $5.7 million, and year-end cash, cash equivalents, restricted cash and marketable securities of $34.9 million. No capital allocation program or buyback/dividend plan was discussed; the call instead implied cash management remains important given the delayed Phase 3 timeline.

Analysts pressed management on the 24-week versus 48/72-week biopsy split, and Allen said only about five patients came from the 72-week group, too few to draw conclusions, so those patients were combined with the 48-week cohort. Questions also focused on why ARMOR is being delayed; management said 80%–90% screen failure rates, uncertainty around biopsies as the primary surrogate endpoint, and lack of validated non-invasive biomarkers make it too risky to launch a pivotal study now. On Amilo-5MER, management said it is still evaluating proof-of-concept options, including IBD and other inflammatory indications, and said partnering is absolutely being considered for later-stage development and non-dilutive financing.