TEL AVIV, Israel, March 13, 2018 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmedˮ 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
and other liver diseases, today reported financial results for
the three and twelve months ended December 31, 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
Aramchol™.
Financial Summary – Full Year 2017 vs. Full Year 2016;
4Q17vs. 4Q16:
- Cash and cash equivalents and marketable securities totaled
$19.0 million as of December 31, 2017, compared with $15.5 million as of December 31, 2016. The increase is primarily
attributable to the $15.1 million of
net proceeds from the Company's different equity offerings and
partially offset by the Company's net loss of approximately
$12.3 million. Galmed believes that
its cash balance will be sufficient to maintain its current
operations through 2019.
- For the three and twelve months ended December 31, 2017, the Company recorded a net
loss of $3.6 million and
$12.3 million or
$0.27 and $0.98 per share, respectively, compared with a
net loss of $4.8 million and
$17.0 million, or $0.40 and $1.49 per share, for the three and twelve
months ended December 31, 2016.
- The Company recognized $1.1
million of revenue for the twelve months ended December 31, 2017, compared to $0.5 million for the same period in 2016. The
revenue relates to the amortization of the up-front payments under
the Company's license agreement with Samil Pharm Co. Ltd. For the
three months ended December 31, 2017,
revenue totaled $0.3 million, the
same as for the cooresponding period in 2016.
- Research and development expenses were $9.7 million for the twelve months ended
December 31, 2017, compared with
$14.3 million for the twelve months
ended December 31, 2016. For the
three months ended December 31, 2017,
research and development expenses totaled $2.2 million, which compares with $4.2 million for the same period in
2016.
- The Company incurred general and administrative expenses of
$3.8 million for the twelve months
ended December 31, 2017, compared
with $3.1 million for the twelve
months ended December 31, 2016. For
the three months ended December 31,
2017, general and administrative expenses totaled
$1.7 million, which compares with
$0.8 million for the same period in
2016.
Conference Call & Webcast:
Tuesday, March 13, 2018,
8:30 am Eastern Time / 5:30 am Pacific Time
Participant Dial-In Numbers:
Toll-Free: +1-800-289-0438
Toll/International:
+1-323-794-2423
Conference
ID:
1228226
Webcast:
http://public.viavid.com/index.php?id=128520
Replay, available through March 27,
2018
Replay Dial-In Numbers:
Toll-Free: +1-844-512-2921
Toll/International:
+1-412-317-6671
Passcode:
1228226
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, 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 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.
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
Aramchol™, 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 Aramchol™; regulatory action
with respect to Aramchol™ by the FDA or the EMA; the commercial
launch and future sales of Aramchol™ or any other future 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 in patients who are
overweight or obese and have pre diabetes or type II diabetes
mellitus; 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, 2018, 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 December 31,
|
|
|
2017
|
2016
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
$
13,021
|
$
3,097
|
Marketable
securities
|
|
5,976
|
12,351
|
Other accounts
receivable
|
|
155
|
284
|
Total current
assets
|
|
19,152
|
15,732
|
|
|
|
|
Property and
equipment, net
|
|
491
|
718
|
|
|
|
|
Total
assets
|
|
$
19,643
|
$
16,450
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Trade
payables
|
|
2,276
|
3,122
|
|
Other accounts
payable
|
|
1,034
|
363
|
|
Short-term portion of
deferred revenue
|
|
538
|
1,094
|
|
Total current
liabilities
|
|
3,848
|
4,579
|
|
|
|
|
|
|
Long-term
liabilities
|
|
|
|
|
Related
parties
|
|
-
|
267
|
|
Long-term portion of
deferred revenue
|
|
-
|
529
|
|
Total long-term
liabilities
|
|
-
|
796
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share;
Authorized 50,000,000
shares;
Issued and
outstanding: 14,435,161 shares as
of December 31, 2017; 12,149,226 shares as
of December 31, 2016
|
|
40
|
34
|
|
Additional paid-in
capital
|
|
92,381
|
75,446
|
|
Accumulated other
comprehensive loss
|
|
(7)
|
(85)
|
|
Accumulated
deficit
|
|
(76,619)
|
(64,320)
|
|
Total stockholders'
equity
|
|
15,795
|
11,075
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
19,643
|
$
16,450
|
|
|
|
|
|
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Operations (Audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
Three months ended
December
31,
|
|
|
Twelve months ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Revenue
|
|
$
|
274
|
|
|
$
|
274
|
|
|
$
|
1,085
|
|
|
$
|
467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
2,229
|
|
|
|
4,185
|
|
|
|
9,650
|
|
|
|
14,271
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,689
|
|
|
|
842
|
|
|
|
3,799
|
|
|
|
3,078
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
3,644
|
|
|
|
4,753
|
|
|
|
12,364
|
|
|
|
16,882
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income), net
|
|
|
-
|
|
|
|
73
|
|
|
|
(65)
|
|
|
|
(35)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
3,644
|
|
|
|
4,826
|
|
|
|
12,299
|
|
|
|
16,847
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
106
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
3,644
|
|
|
$
|
4,826
|
|
|
$
|
12,299
|
|
|
$
|
16,953
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.27
|
|
|
$
|
0.40
|
|
|
$
|
0.98
|
|
|
$
|
1.49
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per
share
|
|
|
13,258,619
|
|
|
|
12,149,226
|
|
|
|
12,487,653
|
|
|
|
11,374,653
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
Year ended
December 31,
|
|
2017
|
2016
|
Cash flow from
operating activities
|
|
|
Net loss for the
year
|
$
(12,299)
|
$
(16,953)
|
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
239
|
169
|
Amortization of
discount/premium on marketable securities
|
21
|
44
|
Loss from realization
of marketable securities
|
143
|
231
|
Linked difference of
marketable securities
|
(167)
|
-
|
Stock-based
compensation expense
|
1,394
|
1,628
|
Changes in
operating assets and liabilities:
|
|
|
Increase (decrease)
in deferred revenue from collaboration agreement
|
(1,085)
|
1,623
|
Decrease in other
accounts receivable
|
129
|
95
|
Increase (decrease)
in trade payables
|
(846)
|
863
|
Increase in
other accounts payable
|
671
|
81
|
Increase (decrease)
in related party
|
(267)
|
90
|
Net cash used in operating activities
|
(12,067)
|
(12,129)
|
|
|
|
Cash flow from
investing activities
|
|
|
Purchase of property
and equipment
|
(21)
|
(17)
|
Proceeds from sale of
property and equipment
|
–
|
13
|
Investment in
securities, available for sale
|
(3,869)
|
(7,615)
|
Proceeds from sale of
securities, available for sale
|
10,325
|
13,955
|
Net cash provided by (used in) investing activities
|
6,444
|
6,336
|
|
|
|
Cash flow from
financing activities
|
|
|
Issuance of stock
offerings, net of issuance costs
|
15,017
|
4,479
|
Proceeds from
exercise of options
|
530
|
255
|
Net cash provided by financing activities
|
15,547
|
4,734
|
Increase
(decrease) in cash and cash equivalents
|
9,924
|
(1,059)
|
Cash and cash
equivalents at the beginning of the year
|
3,097
|
4,156
|
Cash and cash
equivalents at the end of the year
|
$
13,021
|
$
3,097
|
|
|
|
Cash received from
interest
|
$
202
|
$
382
|
Cash paid for
taxes
|
$
–
|
$
106
|
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SOURCE Galmed Pharmaceuticals Ltd.