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Galmed Pharmaceuticals Reports Second Quarter

Key Takeaway: Galmed Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update - Conference Call and Webcast Today at 8:30 a.m. EDT / 5:30 a.m. PDT - TEL AVIV, Israel, July 31, 2017 - Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"),

Full Press Release Details

Galmed Pharmaceuticals Reports Second Quarter
2017 Financial Results and Provides Business Update
- Conference Call and Webcast Today at 8:30
a.m. EDT / 5:30 a.m. PDT -
TEL AVIV, Israel, July 31, 2017 - Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company
focused on the development of a once-daily, oral therapy for the treatment of nonalcoholic steatohepatitis, or NASH, and other
liver diseases, today reported financial results for the three and six months ended June 30, 2017. The Company will host a
conference call and webcast today to discuss the financial results and to provide an update on current developments with respect
to its clinical programs for AramcholTM.
Financial Summary - Second Quarter 2017 vs. Second Quarter 2016:
Conference Call & Webcast:
Monday, July 31, 2017, 8:30 am Eastern
Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
Toll-Free: +1-888-287-5563
Toll/International: +1-719-325-4878
Conference ID: 8068047
Webcast: http://galmedpharma.investorroom.com/events
Replay, available until August 14,
Replay Dial-In Numbers:
Toll-Free: +1-844-512-2921
Toll/International: +1-412-317-6671
Passcode:
and Non-alcoholic Steatohepatitis (NASH)
(arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid
metabolism. AramcholTM's ability to modulate hepatic lipid metabolism was discovered and validated in animal models,
demonstrating down regulation of the three key pathologies of NASH; steatosis, inflammation and fibrosis. The effect of AramcholTM
on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. AramcholTM has
been granted by the FDA Fast Track designation status 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 AramcholTM, a first in class, novel, once-daily, oral therapy for the treatment
of NASH for variable populations, as well as other liver associated disorders. 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 AramcholTM in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. Galmed
also sponsors the ARRIVE Study, a proof-of-concept Phase IIa clinical trial designed to evaluate the safety and efficacy of Aramchol
in up to 50 patients with HIV-associated NAFLD and lipodystrophy. The ARRIVE Study is an investigator-initiated trial, conducted
at the University of California San Diego by Professor Rohit Loomba. More information about the ARREST Study and the ARRIVE Study
may be found on ClinicalTrials.gov identifiers: NCT02279524 and NCT02684591, respectively.
Forward-Looking Statements:
This press release may include forward-looking
statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans
and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed
intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by
terminology such as "believes," "hopes," "may," "anticipates," "should,"
"intends," "plans," "will," "expects," "estimates," "projects,"
"positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light
of management's experience and perception of historical trends, current conditions, expected future developments and other
factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks
and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many
factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated
in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's ongoing Phase
IIb ARREST Study, and planned Phase III trials for AramcholTM, or whether Phase III trials will be conducted at all;
completion and receiving favorable results of these Phase IIb ARREST Study and Phase III trials for AramcholTM; regulatory
action with respect to AramcholTM by the FDA or the EMA; the commercial launch and future sales of AramcholTM
or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory
requirements for AramcholTM in the countries in which it seeks to market the product; Galmed's ability to achieve
favorable pricing for AramcholTM; Galmed's expectations regarding the commercial market for NASH in patients who
are overweight or obese and have pre diabetes or type II diabetes mellitus; third-party payor reimbursement for AramcholTM;
Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption
of AramcholTM by physicians and patients; the timing, cost or other aspects of the commercial launch of AramcholTM;
the development and approval of the use of AramcholTM for additional indications or in combination therapy; and Galmed's
expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties
affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report
on Form 20-F filed with the SEC on March 23, 2017, and in other filings that Galmed has made and may make with the SEC in the future.
The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's
current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update
or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Galmed Investor & Media Contact:
Guy Nehemya, VP Operations
Galmed Pharmaceuticals Ltd.
GALMED PHARMACEUTICALS LTD.
Consolidated Balance Sheets
U.S. Dollars in thousands, except share data and per share data
As of June 30, 2017 As of December 31, 2016
Unaudited Audited
Assets
Current assets
Cash and cash equivalents $ 1,747 $ 3,097
Marketable securities 7,408 12,351
Other accounts receivable 266 284
Total current assets 9,421 15,732
Property and equipment, net 606 718
Total assets $ 10,027 $ 16,450
Liabilities and stockholders' equity
Current liabilities
Trade payables $ 2,365 $ 3,122
Other accounts payable 185 363
Short-term portion of deferred revenue 1,085 1,094
Total current liabilities 3,635 4,579
Long-term liabilities
Related parties 150 267
Long-term portion of deferred revenue - 529
Total long-term liabilities 150 796
Stockholders' equity:
Ordinary shares par value NIS 0.01 per share; Authorized 50,000,000; Issued and outstanding: 12,219,186 shares as of June 30, 2017; 12,149,226 shares as of December 31, 2016 34 34
Additional paid-in capital 76,402 75,446
Accumulated other comprehensive loss (20 ) (85 )
Accumulated deficit (70,174 ) (64,320 )
Total stockholders' equity 6,242 11,075
Total liabilities and stockholders' equity $ 10,027 $ 16,450
GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Operations (Unaudited)
U.S. Dollars in thousands, except share data and per share data
Three months ended June 30, Six months ended June 30,
2017 2016 2017 2016
Revenue $ 270 $ - $ 538 $ -
Research and development expenses 2,347 3,360 5,090 6,744
General and administrative expenses 624 861 1,413 1,580
Total operating expenses 2,701 4,221 5,965 8,324
Financial expenses (income), net (9 ) 89 (111 ) (30 )
Loss before income taxes 2,692 4,310 5,854 8,294
Taxes on Income - 1 - 1
Net loss $ 2,692 $ 4,311 $ 5,854 $ 8,295
Basic and diluted net loss per share $ 0.22 $ 0.39 $ 0.48 $ 0.75
Weighted-average number of shares outstanding used in computing basic and diluted net loss per share 12,175,147 11,100,853 12,171,668 11,100,655
GALMED PHARMACEUTICALS LTD.
Consolidated Statements of Cash Flows (Unaudited)
U.S. Dollars in thousands
Six months ended June 30,
2017 2016
Cash flow from operating activities
Net loss $ (5,854 ) $ (8,295 )
Adjustments required to reconcile net loss to net cash used in operating activities
Depreciation and amortization 120 66
Stock-based compensation expense 709 1,063
Amortization of discount/premium on marketable securities (207 ) 35
Loss from Realization of marketable securities 115 138
Changes in operating assets and liabilities:
Decrease in other accounts receivable 18 43
Increase (decrease) in trade payables (757 ) 706
Increase (decrease) in other accounts payable (178 ) 106
Increase (decrease) in related party (117 ) 45
Decrease in deferred revenue (538 ) -
Net cash used in operating activities (6,689 ) (6,093 )
Cash flow from investing activities
Purchase of property and equipment (8 ) (23 )
Investment in securities, available for sale - (1,212 )
Consideration of securities, available for sale 5,100 6,250
Net cash provided in (used in) investing activities 5,092 5,015
Cash flow from financing activities
Issuance of ordinary shares 247 11
Deferred issuance costs - (143 )
Net cash used in financing activities 247 (132 )
Increase (decrease) in cash and cash equivalents (1,350 ) (1,210 )
Cash and cash equivalents at the beginning of the year 3,097 4,156
Cash and cash equivalents at the end of the period $ 1,747 $ 2,946
Supplemental disclosure of cash flow information:
Cash received from interest $ 136 223
Last updated: Jul 31, 2017