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Galmed Pharmaceuticals Provides Business Update and Reports First Quarter 2018 Financial Results

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PR Newswire

TEL AVIV, Israel, May 9, 2018 /PRNewswire/ --Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of the liver targeted SCD1 modulator Aramchol™, a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, today provides updated information reaffirming the schedule of the release of the ARREST study top line results and reports financial results for the three months ended March 31, 2018. The Company will host a conference call and webcast at 08:30 a.m. ET today.

Galmed Pharmaceuticals Logo

 

Business Update

  • ARREST Phase IIb NASH study:
    Phase IIb top line results for Aramchol™ in 247 NASH patients are expected, as planned during June 2018. All patients completed treatment during the last week of February and the follow-up period is scheduled to end this month. Preparations for a pre-phase III meeting with U.S. Food and Drug Administration (FDA) during the fourth quarter of 2018 are ongoing. 
  •  In April 2018, the Company sold to Biotechnology Value Fund, L.P.  1,000,000 ordinary shares and warrants to purchase 1,000,000 ordinary shares, for a purchase price of $6.00 per share and related warrant. The warrants have an exercise price of $15.00 per share and will expire one year from the date of issuance. The proceeds of this financing are intended to be used for working capital needs, clinical development, business development activities and the advancement of the Company's ongoing pipeline activities.
  • The Company is conducting pre-clinical studies of Aramchol™ in combination with advanced clinical stage representative anti-inflammatory and anti-apoptotic compounds for the treatment of NASH. The Company intends to submit data related to these combinations for presentation at The Liver Meeting®, to take place on November 9-13, 2018 in San Francisco.

Financial Summary - First Quarter 2018 vs. First Quarter 2017:

  • Cash and cash equivalents and marketable securities totaled $15.5 million as of March 31, 2018, compared to $19.0 million at December 31, 2017. As mentioned above, subsequent to the balance sheet date, the Company raised gross proceeds of $6.0 million in a registered direct offering. Galmed believes that its current cash balance will be sufficient to maintain its current operations through the first half of 2020.
  • Net loss of $2.5 million, or $0.17 per share, for the three months ended March 31, 2018, compared to a net loss of $3.2 million, or $0.26 per share, for the three months ended March 31, 2018. This period's net loss included $0.3 million of non-cash, stock-based compensation expense, versus $0.4 million of non-cash stock-based compensation expense incurred during the corresponding period in 2017.
  • The Company recognized $0.3 million of revenue for the three months ended March 31, 2018, the same amount as in the corresponding quarter in 2017. The revenue relates to the amortization of the up-front payments under the license agreement with Samil Pharm.
  • Research and development ("R&D") expenses amounted to approximately $1.9 million for the three months ended March 31, 2018, compared to approximately $2.7 million for the three months ended March 31, 2017. The decrease resulted primarily from a decrease in expenses in connection with the ARREST study.
  • General and administrative expenses amounted to approximately $0.9 million for the three months ended March 31, 2018, compared to approximately $0.8 million for the three months ended March 31, 2017. The slight increase in general and administrative expenses for the three months ended March 31, 2018 resulted primarily from an increase in professional fees.
  • Financial expenses amounted to $0.05 million for the three months ended March 31, 2018, compared to financial income of $0.1 million for the three months ended March 31, 2017. The decrease resulted primarily from changes in the foreign currency exchange rate.

 

Conference Call & Webcast:

Wednesday, May 9th @ 8:30am Eastern Time


ARIVA.DE Börsen-Geflüster

Kurse

Within the US:


800-239-9838

Outside the US:


323-794-2551

From Israel:


1809-212-883

Conference ID:


4575906

Webcast:


http://public.viavid.com/index.php?id=129551




Replays, available through May 23, 2017

Toll-Free:


844-512-2921

Toll/International:


412-317-6671

Replay PIN:


4575906

 

About Aramchol and Non-alcoholic Steatohepatitis (NASH)

Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track designation status by the FDA for the treatment of NASH.

NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.

About Galmed Pharmaceuticals Ltd.

Galmed is a clinical-stage biopharmaceutical company focused on the development of Aramchol, a first in class, novel, once-daily, oral therapy for the treatment of NASH for variable populations. Galmed is currently conducting the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. More information about the ARREST Study may be found on ClinicalTrials.gov identifier: NCT02279524.

 


GALMED PHARMACEUTICALS LTD.







Consolidated Balance Sheets

U.S. Dollars in thousands, except share data and per share data
















As of

March 31,

2018



As of

December 31,

2017




Unaudited



Audited


Assets









Current assets









Cash and cash equivalents


$

2,631



$

13,021


Marketable securities



12,871




5,976


Other accounts receivable



365




155


Total current assets



15,867




19,152











Property and equipment, net



433




491











Total assets


$

16,300



$

19,643











Liabilities and stockholders' equity


















Current liabilities









Trade payables


$

2,196



$

2,276


Other accounts payable



232




1,034


Short-term portion of deferred revenue



270




538


Total current liabilities



2,698




3,848











Stockholders' equity:









Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 14,472,414 shares as of March 31, 2018; 14,435,161 shares as of December 31, 2017



40




40


Additional paid-in capital



92,723




92,381


Accumulated other comprehensive loss



(36)




(7)


Accumulated deficit



(79,125)




(76,619)


Total stockholders' equity



13,602




15,795

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