TEL AVIV, Israel, Aug. 5, 2019 /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 business update and reports financial results
for the three and six months ended June 30,
2019. The Company will host a conference call and webcast at
08:30 ET today.
Financial Summary - Second Quarter 2019 vs. Second Quarter
2018
- Cash and cash equivalents, short-term deposits and
marketable securities totaled $83.6
million as of June 30, 2019,
compared to $90.2 million at
December 31, 2018.
- Net loss of $4.2 million, or
($0.20) per share, for the three
months ended June 30, 2019, compared
to a net loss of $2.7 million, or
($0.17) per share, for the three
months ended June 30, 2018.
- Research and development expenses amounted to approximately
$3.5 million for the three months
ended June 30, 2019, compared to
approximately $1.9 million for the
three months ended June 30, 2018. The
increase resulted primarily from an increase in clinical and
pre-clinical trial expenses.
- General and administrative expenses amounted to approximately
$1.2 million for the three months
ended June 30, 2019, compared to
approximately $1.1 million for the
three months ended June 30,
2018.
- Financial expenses amounted to $0.5
million for the three months ended June 30, 2019, compared to financial income of
$0.1 million for the three months
ended June 30, 2018. The increase
primarily relates to an increase in financial income from financial
assets.
Conference Call &
Webcast:
Monday, August 5th @ 8:30am Eastern Time.
Toll Free:
1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1-809-406-247
Conference ID: 13692794
Webcast: http://public.viavid.com/index.php?id=135464
Replay Dial-In Numbers
Toll Free:
1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13692794
Replay Start: Monday August 5, 2019,
11:30 AM ET
Replay Expiry: Monday August 19,
2019, 11:59 PM ET
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.
During 2018, Galmed rannounced top-line results of 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. Galmed is
currently preparing to initiate a Phase 3/4 clinical study in the
third quarter of 2019.
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
planned pivotal Phase 3/4 ARMOR trial, or the ARMOR Study or
whether a pivotal trial will be conducted at all; completion and
receiving favorable results of the ARMOR Study for Aramchol or any
other pre-clinical or clinical trial; regulatory action with
respect to Aramchol by the FDA or the EMA; the commercial launch
and future sales of Aramchol or any other future products or
product candidates; Galmed's ability to comply with all applicable
post-market regulatory requirements for Aramchol in the countries
in which it seeks to market the product; Galmed's ability to
achieve favorable pricing for Aramchol; Galmed's expectations
regarding the commercial market for NASH patients; third-party
payor reimbursement for Aramchol; Galmed's estimates regarding
anticipated capital requirements and Galmed's needs for additional
financing; market adoption of Aramchol by physicians and patients;
the timing, cost or other aspects of the commercial launch of
Aramchol; the development and approval of the use of Aramchol 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 13,
2019, 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
PHARMACEUTICALS LTD.
|
|
Consolidated
Balance Sheets
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
As of
June
30,
2019
|
|
|
As of
December 31,
2018
|
|
|
|
Unaudited
|
|
|
Audited
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
25,778
|
|
|
$
|
24,159
|
|
Short-term
deposits
|
|
|
15,282
|
|
|
|
6,067
|
|
Marketable debt
securities
|
|
|
42,563
|
|
|
|
59,962
|
|
Other accounts
receivable
|
|
|
705
|
|
|
|
218
|
|
Total current
assets
|
|
|
84,328
|
|
|
|
90,406
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
603
|
|
|
|
-
|
|
Property and
equipment, net
|
|
|
180
|
|
|
|
194
|
|
Total non-current
assets
|
|
|
783
|
|
|
|
194
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
85,111
|
|
|
$
|
90,600
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
2,578
|
|
|
$
|
1,814
|
|
Other accounts
payable
|
|
|
704
|
|
|
|
892
|
|
Total current
liabilities
|
|
|
3,282
|
|
|
|
2,706
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
442
|
|
|
$
|
-
|
|
Total non-current
liabilities
|
|
|
442
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding: 21,121,337 shares as of June 30, 2019; 21,018,919
shares as of December 31, 2018
|
|
|
58
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
175,424
|
|
|
|
174,322
|
|
Accumulated other
comprehensive gain (loss)
|
|
|
41
|
|
|
|
(11)
|
|
Accumulated
deficit
|
|
|
(94,136)
|
|
|
|
(86,475)
|
|
Total
stockholders' equity
|
|
|
81,387
|
|
|
|
87,894
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
85,111
|
|
|
$
|
90,600
|
|
|
|
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,
|
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Revenue
|
|
$
|
-
|
|
|
$
|
270
|
|
|
$
|
-
|
|
|
$
|
538
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
3,494
|
|
|
|
1,940
|
|
|
|
6,763
|
|
|
|
3,884
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,207
|
|
|
|
1,105
|
|
|
|
1,978
|
|
|
|
1,988
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
4,701
|
|
|
|
2,775
|
|
|
|
8,741
|
|
|
|
5,334
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
532
|
|
|
|
90
|
|
|
|
1,080
|
|
|
|
143
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
4,169
|
|
|
$
|
2,685
|
|
|
$
|
7,661
|
|
|
$
|
5,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.20
|
|
|
$
|
0.17
|
|
|
$
|
0.36
|
|
|
$
|
0.34
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic and diluted
net loss per share
|
|
|
21,120,085
|
|
|
|
15,711,736
|
|
|
|
21,102,306
|
|
|
|
15,243,785
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Cash Flows (Unaudited)
|
|
U.S. Dollars in
thousands
|
|
|
|
|
|
Six months
ended
June 30,
|
|
|
|
2019
|
|
|
2018
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(7,661)
|
|
|
$
|
(5,191)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
18
|
|
|
|
118
|
|
Stock-based
compensation expense
|
|
|
1,007
|
|
|
|
417
|
|
Interest income from
short-term deposits
|
|
|
(215)
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Amortization of
discount on marketable securities
|
|
|
(71)
|
|
|
|
(4)
|
|
Loss (gain) from
realization of marketable securities
|
|
|
(9)
|
|
|
|
5
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(487)
|
|
|
|
(213)
|
|
Increase in trade
payables
|
|
|
764
|
|
|
|
70
|
|
Increase (decrease)
in other accounts payable
|
|
|
(349)
|
|
|
|
424
|
|
Decrease in deferred
revenue
|
|
|
-
|
|
|
|
(538)
|
|
Net cash used in
operating activities
|
|
|
(7,003)
|
|
|
|
(4,912)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(4)
|
|
|
|
(1)
|
|
Investment in
available for sale securities
|
|
|
(68,717)
|
|
|
|
(85,174)
|
|
Investment in
short-term deposits
|
|
|
(9,000)
|
|
|
|
-
|
|
Consideration from
sale of available for sale securities
|
|
|
86,248
|
|
|
|
3,173
|
|
Net cash provided
in (used in) investing activities
|
|
|
8,527
|
|
|
|
(82,002)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares and warrants, net of issuance costs
|
|
|
-
|
|
|
|
79,164
|
|
Proceeds from
exercise of options
|
|
|
95
|
|
|
|
880
|
|
Net cash provided
in financing activities
|
|
|
95
|
|
|
|
80,044
|
|
|
|
|
|
|
|
|
|
|
Increase
(Decrease) in cash and cash equivalents
|
|
|
1,619
|
|
|
|
(6,870)
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
24,159
|
|
|
|
13,021
|
|
Cash and cash
equivalents at the end of the period
|
|
$
|
25,778
|
|
|
$
|
6,151
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
1,057
|
|
|
|
171
|
|
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SOURCE Galmed Pharmaceuticals Ltd.