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Biopharma's Amino Acid Compound Shows Anti-Inflammatory Effect
Research Report

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Studies suggest that Galmed Pharmaceuticals' Amilo-5MER has "therapeutic potential in a number of inflammatory diseases," according to an H.C. Wainwright & Co. report.

In an Aug. 20 research note, H.C. Wainwright & Co. analyst Ed Arce reported that preclinical data showing the anti-inflammatory effects of Galmed Pharmaceuticals Ltd.'s (GLMD:NASDAQ) Amilo-5MER were published in The Journal of Autoimmunity.

Arce explained that Amilo-5MER, a compound of five amino acids in a specific sequence, interferes with serum amyloid A polymerization and aggregation. Those amino acids, listed in their requisite sequence, are methionine, threonine, alanine, aspartic acid and valine, or MTADV. Amilo-5MER is believed to selectively bind to serum amyloid A and prevent it from making immune cells secrete pro-inflammatory cytokines.

In his report, the analyst then relayed the study results presented in the journal article, "MTADV 5-MER Peptide Suppresses Chronic Inflammation as well as Autoimmune Pathologies and Unveils a New Potential Target—Serum Amyloid A."

In a mouse model with collagen-induced arthritis, Amino-5MER was shown to inhibit joint inflammation after 10 days of treatment, Arce noted. Two doses were tested, 3 milligrams per kilogram (3 mg/kg) and 10 mg/kg, and each yielded the same effects.

Also, Galmed's Amilo-5MER was shown to reduce in human rheumatoid arthritis fibroblasts levels of the proinflammatory cytokines IL-6 and IL-1β activated by serum amyloid A. The five amino acids out of sequence did not have the same result, indicating the proper sequencing of them is critical to efficacy.

These data sets suggest Amilo-5MER might be used as a treatment in various indications involving inflammation, such as rheumatoid arthritis, inflammatory bowel disease and multiple sclerosis.

As for the first in-human trial of Amilo-5MER, a Phase 1 readout is expected this quarter, Q3/21. Currently, H.C. Wainwright does not include this compound in its valuation model for Galmed.

Of greater interest to the investment firm. because it does not include Amilo-5MER in its valuation model for Galmed, is its Aramchol program, Arce wrote. The next Aramchol catalyst is the release of initial data in Q4/21 for 50 patients in the open-label part of the ARMOR study evaluating the drug in nonalcoholic steatohepatitis and fibrosis.

H.C. Wainwright has a Buy rating and a $25 per share price target on Galmed Pharmaceuticals. This target implies a significant potential return, as the biopharma's current share price is about $2.90.


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Disclosures from H.C. Wainwright & Co., Galmed Pharmaceuticals Ltd., August 20, 2021

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce and Thomas Yip, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Galmed Pharmaceuticals Ltd. (including, without limitation, any option, right, warrant, future, long or short position).

As of July 31, 2021 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Galmed Pharmaceuticals Ltd.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Galmed Pharmaceuticals Ltd. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from Galmed Pharmaceuticals Ltd. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

The Firm does not make a market in Galmed Pharmaceuticals Ltd. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

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