TEL AVIV, Israel, Nov. 12, 2020 /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™, an oral therapy for
the treatment of nonalcoholic steatohepatitis, or NASH and
fibrosis, reports financial results for the three and nine months
ended September 30, 2020. The Company
will host a conference call and webcast at 08:30 ET today.
Financial Summary – Third Quarter 2020 vs. Third Quarter
2019:
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $58.7
million as of September 30,
2020, compared to $75.6
million at December 31,
2019.
- Net loss amounted to $6.9
million, or $0.32 per share,
for the three months ended September 30,
2020, compared to a net loss of $4.5
million, or $0.21 per share,
for the three months ended September 30,
2019.
- Research and development expenses amounted to approximately
$6.5 million for the three months
ended September 30, 2020, compared to
approximately $4.1 million for the
three months ended September 30,
2019. The increase resulted primarily from an increase in
clinical trial expenses in connection with our ongoing ARMOR
study.
- General and administrative expenses amounted to approximately
$1.1 million for the three months
ended September 30, 2020, compared to
approximately $1.0 million for the
three months ended September 30,
2019. The increase in general and administrative expenses
for the three months ended September 30,
2020 resulted primarily from an increase in the cost of the
Company's D&O insurance policy premium.
- Financial income, net amounted to $0.7
million for the three months ended September 30, 2020, compared to financial income,
net of $0.5 million for the three
months ended September 30, 2019. The
increase primarily relates to realization of unrealized gains
from prior periods.
Conference Call & Webcast:
Thursday November 12, 2020,
8:30 AM Eastern Time.
Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406
247
Conference ID: 13711943
Webcast: http://public.viavid.com/index.php?id=141982
Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13711943
Replay Start: Thursday November
12, 2020, 11:30 AM ET
Replay Expiry: Thursday November
26, 2020, 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
registrational study. We are also collaborating with the
Hebrew University in the development of
Amilo-5MER, a 5 amino acid synthetic peptide and plan to initiate a
first in human study by the fourth quarter of 2020.
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
pivotal Phase 3 ARMOR trial, or the ARMOR Study or any other
pre-clinical or clinical trials; completion and receiving favorable
results of the ARMOR Study for Aramchol or any other pre-clinical
or clinical trial; the impact of the COVID-19 pandemic; regulatory
action with respect to Aramchol or any other product candidate 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 or any other product candidate
in the countries in which it seeks to market the product; Galmed's
ability to achieve favorable pricing for Aramchol or any other
product candidate; Galmed's expectations regarding the commercial
market for NASH patients or any other indication; third-party payor
reimbursement for Aramchol or any other product candidate; Galmed's
estimates regarding anticipated capital requirements and Galmed's
needs for additional financing; market adoption of Aramchol or any
other product candidate by physicians and patients; the timing,
cost or other aspects of the commercial launch of Aramchol or any
other product candidate; the development and approval of the use of
Aramchol or any other product candidate 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 12, 2020, 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, 2020
|
|
As of
December 31,
2019
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
16,648
|
$
|
15,931
|
|
Restricted
Cash
|
|
|
113
|
|
112
|
|
Short-term
deposits
|
|
|
10,423
|
|
27,938
|
|
Marketable debt
securities
|
|
|
31,514
|
|
31,622
|
|
Other
receivable
|
|
|
642
|
|
827
|
|
Total current
assets
|
|
|
59,340
|
|
76,430
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
437
|
|
538
|
|
Property and
equipment, net
|
|
|
176
|
|
171
|
|
Total non-current
assets
|
|
|
613
|
|
709
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
$
|
59,953
|
$
|
77,139
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
$
|
5,151
|
$
|
5,999
|
|
Other
payables
|
|
|
899
|
|
935
|
|
Total current
liabilities
|
|
|
6,050
|
|
6,934
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
$
|
247
|
$
|
352
|
|
Total non-current
liabilities
|
|
|
247
|
|
352
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding:
|
|
|
|
|
|
|
|
|
21,312,043 shares as
of September 30, 2020; 21,139,385 shares as of December 31,
2019
|
|
|
58
|
|
58
|
|
Additional paid-in
capital
|
|
|
178,938
|
|
176,696
|
|
Accumulated other
comprehensive gain
|
|
|
90
|
|
35
|
|
Accumulated
deficit
|
|
|
(125,430)
|
|
(106,936)
|
|
Total
stockholders' equity
|
|
|
53,656
|
|
69,853
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
59,953
|
$
|
77,139
|
|
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,
|
|
|
|
|
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Research and
development expenses
|
|
$
|
6,536
|
$
|
|
4,054
|
$
|
17,057
|
$
|
10,817
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,054
|
|
953
|
|
2,811
|
|
2,931
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
7,590
|
|
5,007
|
|
19,868
|
|
13,748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
(685)
|
|
(493)
|
|
(1,374)
|
|
(1,573)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
6,905
|
$
|
4,514
|
$
|
18,494
|
$
|
12,175
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
0.32
|
$
|
0.21
|
$
|
0.87
|
$
|
0.58
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic
|
|
|
|
|
|
|
|
|
|
and diluted net loss
per share
|
|
|
21,268,730
|
|
21,123,418
|
|
21,191,196
|
|
21,109,421
|
|
|
|
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Nine months
ended
|
|
|
September
30
|
|
|
2020
|
|
2019
|
|
|
|
|
|
|
|
|
|
$
|
(18,494)
|
|
$
|
(12,175)
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
28
|
|
|
27
|
Stock-based
compensation expense
|
|
|
1,474
|
|
|
1,546
|
Amortization of
premium (discount) on marketable debt securities
|
|
|
36
|
|
|
(93)
|
Interest income from
short-term deposits
|
|
|
(268)
|
|
|
(161)
|
Gain from realization
of marketable debt securities
|
|
|
(522)
|
|
|
(10)
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
Decrease (Increase)
in other accounts receivable
|
|
|
185
|
|
|
(680)
|
Increase (decrease)
in trade payables
|
|
|
(848)
|
|
|
928
|
Decrease in other
accounts payable
|
|
|
(40)
|
|
|
(253)
|
Net cash used in
operating activities
|
|
|
(18,449)
|
|
|
(10,871)
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(33)
|
|
|
(9)
|
Investment in
available for sale securities
|
|
|
(45,226)
|
|
|
(72,600)
|
Investment in short
term deposits, net
|
|
|
17,783
|
|
|
(14,180)
|
Consideration from
sale of available for sale securities
|
|
|
45,875
|
|
|
91,697
|
Net cash provided
by investing activities
|
|
|
18,399
|
|
|
4,908
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
Proceeds from
exercise of options
|
|
|
61
|
|
|
95
|
Issuance of Ordinary
shares upon ATM, net of issuance cost
|
|
|
707
|
|
|
-
|
Net cash provided
in financing activities
|
|
|
768
|
|
|
95
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
|
|
|
|
Cash and cash
equivalents and restricted cash at the beginning of the period
Cash
and cash equivalents and restricted cash at the end of the
period
|
|
|
718
|
|
|
(5,868)
|
|
|
|
16,043
|
|
|
24,159
|
|
|
$
|
16,761
|
|
$
|
18,291
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
966
|
|
$
|
1,542
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
-
|
|
$
|
679
|
Assets acquired under
operating leases
|
|
$
|
35
|
|
$
|
-
|
View original
content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-reports-third-quarter-2020-financial-results-301171763.html
SOURCE Galmed Pharmaceuticals Ltd.