IPO Report: Galmed Pharmaceuticals (GLMD)

Galmed Pharmaceuticals (GLMD) is a clinical-stage biopharmaceutical company headquartered in Tel Aviv, Israel,.

Four other companies are scheduled for the week of March 10, 2014.  The full IPO calendar is available at IPOpremium.
The manager is Maxim Group. The co-managers are MLV and Feltl.  SEC Filings

GLMD scheduled a $31 million IPO with a market capitalization of $132 million at a price range midpoint of $13 for Thursday, March 13, 2014 on the Nasdaq.

End of lockup (180 days): September 9, 2014

End of 25-day quiet period: Monday, April 7, 2014

Overview
GLMD is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones.

GLMD currently expects results from the Phase IIb trial to be available in the second half of 2016

There are no paying collaborations and shareholders haven’t indicated an interest in buying on the IPO.

Valuation

Glossary

Conclusion
GLMD Phase IIb trial results aren’t expected until the 2^nd half of 2016. 

There are no paying collaborations and shareholders haven’t indicated an interest in buying on the IPO.

The rating on GLMD is neutral at the price range mid-point.

Business

GLMD is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing GLMD’s proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs.

GLMD believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including Non-Alcoholic Steato-hepatitis, or NASH, which is a chronic disease that constitutes a large unmet medical need.

NASH is a severe form of Non-Alcoholic Fatty Liver Disease, or NAFLD, which is characterized by inflammation in the liver in addition to the presence of excess liver fat.

NASH is often discovered incidentally, often times by elevated liver enzyme levels in blood tests.

NASH patients may be asymptomatic or suffer from fatigue, with other symptoms occurring as the liver disease advances.

As the disease progresses, persistent fatty infiltration and inflammation cause liver damage marked by fibrosis and the gradual loss of normal liver cells, which dramatically increases the risk of late-stage severe liver diseases, such as cirrhosis, carcinoma and end-stage liver disease, each potentially requiring liver transplantation. In addition to its serious hepatic complications, NASH is also associated with an increased risk of cardiovascular complications, adding to the risks associated with metabolic syndrome.

Metabolic syndrome is a serious health condition caused by obesity, physical inactivity and genetic factors that results in a higher risk of cardiovascular disease, diabetes, stroke and NASH.

Patients with NASH have an increased overall mortality rate, as compared to control populations, and independent third-party epidemiological studies have shown that such increased mortality is a result of liver-related mortality and a higher risk of cardiovascular disease associated with NASH, independently of the risks associated with metabolic syndrome.

Clinical trials
During the second half of 2014, GLMD intends to begin a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance.

GLMD currently expects results from the Phase IIb trial to be available in the second half of 2016.

During this Phase IIb trial, and once 120 patients complete six months of treatment, GLMD intends to conduct an interim analysis of the efficacy and safety of aramchol based on blood markers of inflammation. GLMD currently expects results from the interim analysis to be available in the second half of 2015.

Collaborations
GLMD is currently collaborating with Enterome on the development of a non-invasive biomarker which, if successful, may help to stratify patients for a planned Phase III clinical trial and may help to predict individual responses to aramchol for the treatment of liver diseases.

Enterome also granted GLMD a right of first refusal, exercisable upon completion of the Phase IIb clinical trial, to enter into a business transaction with Enterome regarding the commercial exploitation of its metagenomic profiles and metagenomic data generated during the collaboration.

In addition, GLMD is collaborating with Zora in order to identify the lipidomic profile for NASH patients responding to aramchol treatment. Zora granted GLMD a right of first discussion, exercisable upon completion of the Phase IIb clinical trial, to enter into a business transaction with Zora regarding the commercial exploitation of its NASH disease clinical diagnostic tool based upon the data generated during our collaboration.

Dividend Policy

No dividends are planned.

Intellectual Property

GLMD owns patent rights to aramchol in various jurisdictions worldwide, including within and outside of Israel.

GLMD has sought patent protection in the United States and internationally for aramchol and its discovery programs, and any other inventions to which GLMD has rights, where available and when appropriate.

GLMD expects that patent protection covering the use of aramchol for the treatment of fatty liver will not expire until 2022 (2021 in Israel), subject to any applicable extensions then-available.

Competition

GLMD believes that aramchol offers key potential advantages over other drugs in development that could enable aramchol, if approved for these indications, to capture meaningful market share.

GLMD believes that aramchol’s ability, as observed in its studies to date, to reduce liver fat content without adverse side effects, which GLMD believes may prove to have an anti-inflammatory effect, and convenient once-daily oral administration make aramchol a potentially valuable drug for the treatment of liver disease.

Other companies, including Intercept Pharmaceuticals, Inc., Genfit S.A., Gilead Sciences, Inc. and Novo Nordisk have agonists and antibodies in Phase II or earlier stages of clinical development for the treatment of NASH and the fibrosis associated therewith.

Antibodies cannot be delivered orally. In addition, Raptor Pharmaceutical Corp. is developing a treatment targeted at NAFLD in children, which may compete with aramchol should GLMD develop and commercialize aramchol for such indication.

Some of these companies are focusing their trials on NASH patients with advanced fibrosis, whereas GLMD’s studies relate to NASH, or the onset of fat accumulation in and inflammation of the liver, in which GLMD expects that aramchol will reduce and eventually eliminate liver inflammation by reducing the fat content of the liver.

5% stockholders

Allen Baharaff          37.62%

Chaim Hurvitz            9.34%

David and Debora Goldfarb 6.77%

Use of proceeds

GLMD expects to net about $28 millon from its IPO. Proceeds are allocated as follows:

for clinical trials and product development, including $10 million for the initiation and completion of the Phase IIb clinical trial of aramchol for the treatment of NASH in patients who also suffer from obesity and insulin resistance;

$5 million for establishing and building a research and development infrastructure in the United States, including hiring a new vice president for North America;

$5 million for conducting other studies in connection with the product candidate, including but not limited to, PK studies and food effect studies, and

for working capital and general corporate purposes