TEL AVIV, Israel, Nov. 6, 2019 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of Aramchol, a liver targeted, oral SCD1 modulator currently in a
Phase 3/4 clinical trial for the treatment of nonalcoholic
steatohepatitis ("NASH") and fibrosis provides today a business
update and reports financial results for the three and nine months
ended September 30, 2019. The Company
will host a conference call and webcast at 08:30 ET today.
Business Development
During the past quarter, the Company announced the initiation of
its Phase 3/4 ARMOR, a double-blind, placebo-controlled, global
study, to evaluate the efficacy and safety of Aramchol in subjects
with NASH and fibrosis. The study is designed to consist of two
parts. In the first part (Histology-Based) 1200 subjects will be
treated with Aramchol or matching placebo for 52 weeks. The
Histology-Based data will serve as the basis for the submission of
a marketing authorization application under regulatory provisions
of accelerated/conditional approval. In the second part
(clinically-based), all subjects will continue with the same
treatment assignment until study completion to confirm clinical
efficacy.
The ARMOR study will be conducted in approximately 185 sites in
the U.S., Europe, Latin America and Asia and the Company aims to complete
enrollment by the second quarter of 2021 and report top-line
results by the fourth quarter of 2022.
Financial Summary - Third Quarter 2019 vs. Third Quarter
2018:
- Cash and cash equivalents, short-term deposits and marketable
securities totaled $79.7 million as
of September 30, 2019, compared to
$90.2 million at December 31, 2018.
- Net loss of $4.5 million, or
($0.21) per share, for the three
months ended September 30, 2019,
compared to a net loss of $1.0
million, or ($0.05) per share,
for the three months ended September 30,
2018.
- Research and development expenses amounted to approximately
$4.1 million for the three months
ended September 30, 2019, compared to
approximately $1.7 million for the
three months ended September 30,
2018. The increase resulted primarily from an increase in
clinical, pre-clinical trial expenses and drug development expenses
related to our continuing preparations of the ARMOR trial.
- General and administrative expenses amounted to approximately
$1.0 million for the three months
ended September 30, 2019, compared to
approximately $1.0 million for the
three months ended September 30,
2018.
- Financial expenses amounted to $0.5 million for the three months ended
September 30, 2019, compared to
financial income of $0.3 million for
the three months ended September 30,
2018. The increase primarily relates to an increase in
financial income from financial assets.
Conference Call & Webcast:
Wednesday, November
6th @ 8:30am Eastern
Time.
|
Toll Free:
|
1-855-327-6837
|
|
Toll/International:
|
1-631-891-4304
|
|
Israel Toll
Free:
|
1-809-458-327
|
|
Conference
ID:
|
10007881
|
|
Webcast:
|
http://public.viavid.com/index.php?id=136591
|
Replay Dial-In Numbers
|
Toll Free:
|
1-844-512-2921
|
|
Toll/International:
|
1-412-317-6671
|
|
Replay Pin
Number:
|
10007881
|
|
Replay
Start:
|
Monday November 6,
2019, 11:30 AM ET
|
|
Replay
Expiry:
|
Monday November 20,
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 Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases. Our lead compound, Aramchol™, a backbone drug candidate
for the treatment of NASH and fibrosis is currently in a Phase 3/4
registrational study.
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;
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
September
30,
2019
|
|
|
As of
December 31,
2018
|
|
|
Unaudited
|
|
|
Audited
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
18,291
|
|
|
$
|
24,159
|
Short-term
deposits
|
|
|
20,408
|
|
|
|
6,067
|
Marketable debt
securities
|
|
|
41,031
|
|
|
|
59,962
|
Other accounts
receivable
|
|
|
898
|
|
|
|
218
|
Total
current assets
|
|
|
80,628
|
|
|
|
90,406
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
548
|
|
|
|
-
|
Property and
equipment, net
|
|
|
176
|
|
|
|
194
|
Total
non-current assets
|
|
|
724
|
|
|
|
194
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
81,352
|
|
|
$
|
90,600
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
2,742
|
|
|
$
|
1,814
|
Other accounts
payable
|
|
|
798
|
|
|
|
892
|
Total
current liabilities
|
|
|
3,540
|
|
|
|
2,706
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
389
|
|
|
$
|
-
|
Total non-current
liabilities
|
|
|
389
|
|
|
|
-
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000;
Issued and outstanding:
21,124,110 shares as of September 30, 2019;
21,018,919 shares as of December 31,
2018
|
|
|
58
|
|
|
|
58
|
Additional paid-in
capital
|
|
|
175,963
|
|
|
|
174,322
|
Accumulated other
comprehensive gain (loss)
|
|
|
52
|
|
|
|
(11)
|
Accumulated
deficit
|
|
|
(98,650)
|
|
|
|
(86,475)
|
Total
stockholders' equity
|
|
|
77,423
|
|
|
|
87,894
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
81,352
|
|
|
$
|
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
September 30,
|
|
|
Nine
months ended
September 30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
Revenue
|
|
$
|
-
|
|
|
$
|
1,500
|
|
|
$
|
-
|
|
|
$
|
2,038
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
4,054
|
|
|
|
1,693
|
|
|
|
10,817
|
|
|
|
5,577
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
953
|
|
|
|
987
|
|
|
|
2,931
|
|
|
|
2,975
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
5,007
|
|
|
|
1,180
|
|
|
|
13,748
|
|
|
|
6,514
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
493
|
|
|
|
296
|
|
|
|
1,573
|
|
|
|
439
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
4,514
|
|
|
|
884
|
|
|
|
12,175
|
|
|
|
6,075
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
|
-
|
|
|
|
75
|
|
|
|
-
|
|
|
|
75
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
4,514
|
|
|
$
|
959
|
|
|
$
|
12,175
|
|
|
$
|
6,150
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.21
|
|
|
$
|
0.05
|
|
|
$
|
0.58
|
|
|
$
|
0.36
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted
net loss
per share
|
|
|
21,123,418
|
|
|
|
20,953,421
|
|
|
|
21,109,421
|
|
|
|
17,167,911
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
Nine months
ended
September 30,
|
|
|
2019
|
|
|
2018
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(12,175)
|
|
|
$
|
(6,150)
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
27
|
|
|
|
261
|
Stock-based
compensation expense
|
|
|
1,546
|
|
|
|
1,045
|
Interest income from
short-term deposits
|
|
|
(161)
|
|
|
|
(21)
|
Amortization of
discount on marketable securities
|
|
|
(93)
|
|
|
|
(81)
|
Loss (gain) from
realization of marketable securities
|
|
|
(10)
|
|
|
|
13
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
Increase in other
accounts receivable
|
|
|
(680)
|
|
|
|
(131)
|
Increase
(decrease) in trade payables
|
|
|
928
|
|
|
|
(988)
|
Decrease in other
accounts payable
|
|
|
(253)
|
|
|
|
(183)
|
Decrease in deferred
revenue
|
|
|
-
|
|
|
|
(538)
|
Net cash used in
operating activities
|
|
|
(10,871)
|
|
|
|
(6,773)
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(9)
|
|
|
|
(53)
|
Investment in
available for sale securities
|
|
|
(72,600)
|
|
|
|
(88,180)
|
Investment in
short-term deposits, net
|
|
|
(14,180)
|
|
|
|
(6,000)
|
Consideration from
sale of available for sale securities
|
|
|
91,697
|
|
|
|
33,907
|
Net cash provided
in (used in) investing activities
|
|
|
4,908
|
|
|
|
(60,326)
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
Issuance of ordinary
shares and warrants, net of issuance costs
|
|
|
-
|
|
|
|
79,118
|
Proceeds from
exercise of options
|
|
|
95
|
|
|
|
943
|
Net cash provided
in financing activities
|
|
|
95
|
|
|
|
80,061
|
|
|
|
|
|
|
|
|
Increase
(Decrease) in cash and cash equivalents
|
|
|
(5,868)
|
|
|
|
12,962
|
Cash and cash
equivalents at the beginning of the period
|
|
|
24,159
|
|
|
|
13,021
|
Cash and cash
equivalents at the end of the period
|
|
$
|
18,291
|
|
|
$
|
25,983
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
1,542
|
|
|
|
513
|
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
679
|
|
|
|
-
|
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SOURCE Galmed Pharmaceuticals Ltd.