Recent Updates
Recently added Catalysts
GLMD

THE COMPANY Except as otherwise indicated herein or as the context otherwise requires, references to the "Company," "Galmed," "we," "us," "our" or similar references mean Galmed Pharmaceuticals Ltd., a corporation formed

Key Takeaway: Except as otherwise indicated herein or as the context otherwise requires, references to the "Company," "Galmed," "we," "us," "our" or similar references mean Galmed Pharmaceuticals Ltd., a corporation formed under the laws of the State of Israel, and its subsidiaries, and (ii

Full Press Release Details

Except as otherwise indicated
herein or as the context otherwise requires, references to the "Company," "Galmed," "we,"
"us," "our" or similar references mean Galmed Pharmaceuticals Ltd., a corporation formed under the laws
of the State of Israel, and its subsidiaries, and (ii) Aramchol mean Aramchol acid or Aramchol meglumine (salt).
are a clinical-stage biopharmaceutical company focused on the development of Aramchol, a liver targeted stearoyl-coenzyme A desaturase-1,
or SCD1, modulator, first in class, novel, oral therapy for the treatment of NASH for various populations. We are also collaborating
with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide.
believe that our lead product candidate, Aramchol has the potential to be a disease modifying treatment for fatty liver disorders,
including NASH, which is a chronic disease that constitutes a large unmet medical need.
is a synthetic conjugate of cholic acid, or a type of bile acid, and arachidic acid, or a type of saturated fatty acid, both of
which, in their non-synthetic forms, are naturally occurring. The conjugated molecule acts upon important metabolic pathways,
reducing fat accumulation in the liver, improving fatty acid oxidation and regulating the transport of cholesterol. The ability
of Aramchol to decrease liver fat content may also reduce the inflammation and fibrosis in the liver and the risk of cardiovascular
complications associated with NASH. Pre-clinical studies suggest Aramchol's effect on fibrosis is also direct via collagen
production from human hepatic stellate cells. We believe that Aramchol's ability to reduce liver fat and liver fibrosis
and the safety profile observed to date will enable it to be a treatment for all stages of NASH in patients who are overweight
or obese and have pre diabetes or type II diabetes mellitus and prevent the hepatic complications associated therewith.
following is a summary of our pipeline of programs:
April 2019, we completed our End-of-Phase 2 meeting with the FDA and reached general agreement on key aspects of the Phase 3 development
and registration plan for Aramchol and on the pivotal registration study ARMOR. In September 2019, we initiated our Phase 3 ARMOR
Study to evaluate the efficacy and safety of Aramchol in subjects with NASH and fibrosis. The ARMOR Study was originally comprised
of two parts, a randomized, double-blind, placebo-controlled histology-based registrational part and a clinically based part where
subjects will continue with the same treatment for approximately five years. In December 2020, we announced the addition of an
open label part to the ARMOR Study and temporarily suspended randomization of new patients into the double-blind, placebo-controlled
histology-based registrational part of ARMOR as currently enrolled patients are transitioned to the open label part. We are seeking
to introduce Aramchol meglumine into the randomized, double-blind, placebo-controlled part of ARMOR and are planning to hold a
Type C meeting with the FDA in the second quarter of 2021 to discuss the plan for transition.
September 2020, we announced that we entered into a research agreement with Gannex Pharma Co. Ltd, or Gannex, a wholly owned company
of Ascletis Pharma Inc (HKEX:1672), or Ascletis, aiming at combination therapy of ASC41 (THR-beta agonist) and Aramchol (SCD 1
inhibitor) for the treatment NASH.
November 2020, we announced that we entered into a research and development collaboration agreement with MyBiotics to identify
and optimize the selected microbiome repertoire associated with the response to Aramchol. The research will also focus on development
of a standalone microbiome-based treatment for NASH and fibrosis.
unaudited cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities as of December 31, 2020
a preliminary unaudited basis, our cash and cash equivalents, restricted cash, short-term deposits and marketable debt securities
as of December 31, 2020 was approximately $51.0 million. The foregoing estimate of our cash and cash equivalents, restricted cash,
short-term deposits and marketable debt securities is our preliminary estimate based on currently available information. It does
not present all necessary information for an understanding of our financial condition as of December 31, 2020 or our results of
operations for the year ended December 31, 2020. As we complete our year-end financial close process and finalize our 2020 audited
financial statements, we will be required to make significant judgments in a number of areas that may result in the estimate provided
herein being different than the final reported cash, cash equivalents and marketable securities as of December 31, 2020. This
preliminary financial information has been prepared by, and is the responsibility of our management. Brightman Almagor Zohar &
Co., Member of Deloitte Touche Tohmatsu Limited has not audited, reviewed or applied agreed-upon procedures with respect to the
preliminary financial data. Accordingly, Brightman Almagor Zohar & Co., Member of Deloitte Touche Tohmatsu Limited does not
express an opinion or any other form of assurance with respect thereto. We expect to complete our audited financial statements
for the year ended December 31, 2020 subsequent to the completion of this report on Form 6-K. It is possible that we or our independent
registered public accounting firm may identify items that require us to make adjustments to the preliminary estimated cash and
cash equivalents, restricted cash, short-term deposits and marketable debt securities balance set forth above and those changes
could be material. Accordingly, undue reliance should not be placed on the preliminary financial data. The preliminary financial
data is not necessarily indicative of any future period.
May 15, 2020, we entered into an amended and restated sales agreement, or the Sales Agreement, with Stifel, Nicolaus & Company,
Incorporated, or Stifel, and Cantor Fitzgerald & Co., or Cantor Fitzgerald, and together with Stifel, the Sales Agents, pursuant
to which we may offer and sell our ordinary shares from time to time through the Sales Agents. Pursuant to a prospectus supplement
dated May 15, 2020, or the ATM Sales Prospectus, we may offer and sell up to $31,900,000 of our ordinary shares under the Sales
Agreement. As of February 15, 2020, we have sold 1,677,700 ordinary shares having an aggregate offering price of $9,222,685 under
the Sales Agreement (the settlement of which 1,541,400 ordinary shares is still pending) and we may sell up to an additional $22,677,315
of our ordinary shares under the Sales Agreement, representing the balance that may be sold pursuant to the ATM Sales Prospectus.
principal executive offices and registered office in Israel are located at 16 Tiomkin Street, Tel Aviv, Israel, 6578317 and our
telephone number is +972-3-693-8448. Our Amended and Restated Articles of Association, or Articles, are on file in Israel with
the office of the Israeli Registrar of Companies and available for public inspection at that office. Our website address is http://www.galmedpharma.com.
The information contained on, or that can be accessed through, our website is neither a part of nor incorporated into this report
on Form 6-K. We have included our website address in this report on Form 6-K solely as an inactive textual reference.
investment in our ordinary shares is subject to a number of risks. The following summarizes some, but not all, of these risks.
Please carefully consider all of the information discussed in "Risk Factors" in this report on Form 6-K for a more
thorough description of these and other risks.
Risks Related to Our Financial Position
and Capital Requirements
Risks Related to Our Business, Industry
and Regulatory Requirements
Risks Related to Our Reliance on Third
Risks Related to Our Intellectual Property
Risks Related to Ownership of Our Ordinary
Risks Related to Israeli Law and Our
Operations in Israel
An investment in our
ordinary shares involves a high degree of risk. Prior to making a decision about investing in our ordinary shares, you should
carefully consider the risks, uncertainties and assumptions set forth below. Additional risks and uncertainties not presently
known to us, or that we currently see as immaterial, may also harm our business. If any of these risks occur, our business, financial
condition and operating results could be harmed, the trading price of our ordinary shares could decline and you could lose part
or all of your investment.
6-K also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially
from those anticipated in these forward-looking statements as a result of certain factors, including the risks faced by us described
below and elsewhere in this report on Form 6-K. See "Cautionary Note Regarding Forward-Looking Statements" for information
relating to these forward-looking statements.
Related to Our Financial Position and Capital Requirements
We are a clinical-stage biopharmaceutical
company with a history of operating losses. We expect to incur significant additional losses in the future and may never be profitable.
We are a clinical-stage
biopharmaceutical company with an operating history limited to pre-clinical and clinical drug development and no approved products.
In addition, we have limited operating experience and have not yet demonstrated an ability to successfully overcome many of the
risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the pharmaceutical
industry. We have funded our research and development programs and operations to date primarily through proceeds from private
placements and public offerings. We currently have no products approved for marketing in the United States or any other jurisdiction
and have not generated any revenue from product sales to date, although we have generated revenue from our licensing agreement
with Samil Pharm. Co., Ltd., or Samil. We have incurred operating losses in each year since the inception of our predecessor in
2000. Our loss attributable to holders of our ordinary shares for the years ended December 31, 2018 and 2019 and for the nine
months ended September 30, 2020 was approximately $9.9 million, $20.5 million and $18.5 million, respectively. As of September
30, 2020, we had an accumulated deficit of $125.4 million. Substantially all of our operating losses resulted from costs incurred
in connection with our development program and from general and administrative costs associated with our operations.
Our ability to become
Last updated: Feb 16, 2021