TEL AVIV, Israel, Aug. 2,
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 business update and reports financial results
for the three and six months ended June 30,
2018. The Company will host a conference call and webcast at
08:30 ET today.
Business Update
- In June 2018, the Company
reported top line results in its global, 52 week, Phase IIb ARREST
study on 247 NASH patients demonstrating that Aramchol™ 600 mg
achieved a regulatory approvable endpoint showing NASH resolution
without worsening of fibrosis. Full top line results can be viewed
in the Company's press release dated June
12, 2018 and in a corporate presentation dated June 2018, both of which are available on the
Company's website and in the Company's filings with the SEC. The
Company is preparing for an end of Phase IIb meeting with the FDA
to discuss the results of the ARREST study and the design of a
pivotal study.
- In June 2018, the Company
completed an underwritten public offering of 5,000,000 ordinary
shares, at a price of $15.00 per share. Net proceeds,
after deducting underwriting discounts and commissions and offering
expenses, were $70.3 million.
- In April 2018, the Company sold to Biotechnology Value
Fund, L.P. and certain of its affiliates 1,000,000 ordinary
shares for a purchase price of $6.00
per share, and one-year warrants to purchase an additional
1,000,000 ordinary shares, with an exercise price
of $15.00 per share. Net proceeds to the Company were
$5.9 million.
Financial Summary - First Quarter 2018 vs. First Quarter
2017:
- Cash and cash equivalents and marketable securities totaled
$94.1 million as of June 30, 2018, compared to $19.0 million at December
31, 2017. The increase is mainly attributable to the
approximately $70.3 million in net
proceeds raised in an underwritten public offering that was
completed in June 2018, together with
$5.9 million in net proceeds raised
in a registered direct offering during April
2018.
- Net loss of $2.7 million, or
($0.17) per share, for the three
months ended June 30, 2018, compared
to a net loss of $2.7 million, or
($0.22) per share, for the three
months ended June 30, 2018.
- The Company recognized $0.3
million of revenue for the three months ended June 30, 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 Pharma.
- Research and development expenses amounted to approximately
$1.9 million for the three months
ended June 30, 2018, compared to
approximately $2.3 million for the
three months ended June 30, 2017. The
decrease resulted primarily from a decrease in expenses in
connection with clinical studies.
- General and administrative expenses amounted to approximately
$1.1 million for the three months
ended June 30, 2018, compared to
approximately $0.6 million for the
three months ended June 30, 2017. The
increase in general and administrative expenses for the three
months ended June 30, 2018 resulted
primarily from a provision for employees' year-end compensation, as
well as an increase in professional services.
- Financial expenses amounted to $0.1
million for the three months ended June 30, 2018, compared to financial income of
$0.01 million for the three months
ended June 30, 2017.
Conference Call & Webcast:
Thursday,
August 2 @ 8:30am Eastern Time
|
Within the
US:
|
888-394-8218
|
Outside the
US:
|
323-701-0225
|
From
Israel:
|
1809 212
883
|
Conference
ID:
|
5856233
|
Webcast:
|
http://public.viavid.com/index.php?id=130659
|
|
|
Replays, Available
through August
16:
|
Domestic:
|
844-512-2921
|
International:
|
412-317-6671
|
Replay
PIN:
|
5856233
|
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 recently announced 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 for an end of Phase IIb meeting with the FDA to discuss
the results of the ARREST Study and a Phase III study protocol,
with a view to initiating a Phase III clinical study of Aramchol in
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 Phase III trial for Aramchol, or whether a Phase III trial
will be conducted at all; completion and receiving favorable
results of a Phase III trial 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; 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 June 30, 2018
|
|
|
As of December 31, 2017
|
|
|
|
Unaudited
|
|
|
Audited
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
6,151
|
|
|
$
|
13,021
|
|
Marketable
securities
|
|
|
87,954
|
|
|
|
5,976
|
|
Other accounts
receivable
|
|
|
368
|
|
|
|
155
|
|
Total current
assets
|
|
|
94,473
|
|
|
|
19,152
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
374
|
|
|
|
491
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
94,847
|
|
|
$
|
19,643
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
2,346
|
|
|
$
|
2,276
|
|
Other accounts
payable
|
|
|
1,458
|
|
|
|
1,034
|
|
Short-term portion of
deferred revenue
|
|
|
-
|
|
|
|
538
|
|
Total current
liabilities
|
|
|
3,804
|
|
|
|
3,848
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000;
Issued and outstanding: 20,912,754 shares as of June 30, 2018;
14,435,161 shares as of December 31, 2017
|
|
|
58
|
|
|
|
40
|
|
Additional paid-in
capital
|
|
|
172,824
|
|
|
|
92,381
|
|
Accumulated other
comprehensive loss
|
|
|
(29)
|
|
|
|
(7)
|
|
Accumulated
deficit
|
|
|
(81,810)
|
|
|
|
(76,619)
|
|
Total stockholders'
equity
|
|
|
91,043
|
|
|
|
15,795
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
94,847
|
|
|
$
|
19,643
|
|
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,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenue
|
|
$
|
270
|
|
|
$
|
270
|
|
|
$
|
538
|
|
|
$
|
538
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
1,940
|
|
|
|
2,347
|
|
|
|
3,884
|
|
|
|
5,090
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,105
|
|
|
|
624
|
|
|
|
1,988
|
|
|
|
1,413
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
2,775
|
|
|
|
2,701
|
|
|
|
5,334
|
|
|
|
5,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income), net
|
|
|
(90)
|
|
|
|
(9)
|
|
|
|
(143)
|
|
|
|
(111)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
2,685
|
|
|
|
2,692
|
|
|
|
5,191
|
|
|
|
5,854
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
2,685
|
|
|
$
|
2,692
|
|
|
$
|
5,191
|
|
|
$
|
5,854
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.17
|
|
|
$
|
0.22
|
|
|
$
|
0.34
|
|
|
$
|
0.48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per share
|
|
|
15,711,736
|
|
|
|
12,175,147
|
|
|
|
15,243,785
|
|
|
|
12,171,668
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Six months
ended June
30,
|
|
|
2018
|
|
|
2017
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(5,191)
|
|
|
$
|
(5,854)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used
in operating activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
118
|
|
|
|
120
|
|
Stock-based
compensation expense
|
|
|
417
|
|
|
|
709
|
|
Amortization of
discount/premium on marketable securities
|
|
|
(4)
|
|
|
|
(207)
|
|
Loss from Realization
of marketable securities
|
|
|
5
|
|
|
|
115
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(213)
|
|
|
|
18
|
|
Increase (decrease)
in trade payables
|
|
|
70
|
|
|
|
(757)
|
|
Increase (decrease)
in other accounts payable
|
|
|
424
|
|
|
|
(178)
|
|
Decrease in related
party
|
|
|
-
|
|
|
|
(117)
|
|
Decrease in deferred
revenue
|
|
|
(538)
|
|
|
|
(538)
|
|
Net cash used in
operating activities
|
|
|
(4,912)
|
|
|
|
(6,689)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(1)
|
|
|
|
(8)
|
|
Investment in
available for sale securities
|
|
|
(85,174)
|
|
|
|
-
|
|
Consideration from
sale of available for sale securities
|
|
|
3,173
|
|
|
|
5,100
|
|
Net cash provided
in (used in) investing activities
|
|
|
(82,002)
|
|
|
|
5,092
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Issuance of Ordinary
Shares
|
|
|
79,164
|
|
|
|
-
|
|
Proceeds from
exercise of options
|
|
|
880
|
|
|
|
247
|
|
Net cash provided
in financing activities
|
|
|
80,044
|
|
|
|
247
|
|
|
|
|
|
|
|
|
|
|
Decrease in cash
and cash equivalents
|
|
|
(6,870)
|
|
|
|
(1,350)
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
13,021
|
|
|
|
3,097
|
|
Cash and cash
equivalents at the end of the period
|
|
$
|
6,151
|
|
|
$
|
1,747
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
171
|
|
|
|
136
|
|
View original
content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-update-and-reports-second-quarter-2018-financial-results-300690935.html
SOURCE Galmed Pharmaceuticals Ltd.