TEL AVIV, Israel, Aug. 5, 2021 /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, provides today updated information on the Company's
scientific and clinical development programs and reports financial
results for the three and six months ended June 30, 2021. The Company will host a conference
call and webcast at 08:30 ET
today.
Recent Clinical & Scientific Developments
- The FDA agreed with Galmed's plan to use Aramchol meglumine in
the randomized double-blind placebo-controlled part of the Phase 3
ARMOR study.
- Results from approximately one-third of the study population (~
50 subjects) of the open label part of our ARMOR study that has
completed the post-baseline liver biopsy are expected to be
available in Q4 2021 as planned.
- Completed dosing in first in human Phase I trial of Amilo-5-Mer
with topline data expected in Q3 2021 and a Phase 1b proof of concept study is planned for Q4
2021.
- Entered into a license agreement with Yissum pursuant to which
Yissum granted to the Company a worldwide, exclusive and
irrevocable license to develop and commercialize Amilo-5Mer.
Financial Summary – Second Quarter 2021 vs. Second Quarter
2020:
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $51.2
million as of June 30, 2021,
compared to $50.9 million at
December 31, 2020.
- Net loss amounted to $8.4
million, or $0.33 per share,
for the three months ended June 30,
2021, compared to a net loss of $5.5
million, or $0.26 per share,
for the three months ended June 30,
2020.
- Research and development expenses amounted to approximately
$7.0 million for the three months
ended June 30, 2021, compared to
approximately $5.0 million for the
three months ended June 30, 2020. The
increase resulted primarily from an increase in clinical trial
expenses in connection with the ARMOR study.
- General and administrative expenses amounted to approximately
$1.4 million for the three months
ended June 30, 2021, compared to
approximately $0.8 million for the
three months ended June 30, 2020. The
increase in general and administrative expenses for the three
months ended June 30, 2021 resulted
primarily from an increase in salaries and benefits, as well from
an increase in the cost of our D&O insurance policy
premium.
- Financial income, net amounted to $0.01
million for the three months ended June 30, 2021, compared to financial income, net
of $0.3 million for the three months
ended June 30, 2020. The decrease
primarily relates to a decrease in interest income from financial
assets.
Conference Call &
Webcast:
Thursday August 5,
2021, 8:30 AM
ET
Toll Free: 1-888-394-8218
Toll/International: 1-323-701-0225
Israel Toll Free: 1 809 212 883
Conference ID: 2905012
Webcast: http://public.viavid.com/index.php?id=145911
Replay Dial-In Numbers
Toll Free:
1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 2905012
Replay Start: Thursday August 5,
2021, 11:30 AM ET
Replay Expiry: Thursday August 19,
2021, 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 developing Amilo-5MER, a 5 amino
acid synthetic peptide and recently initiated a first in human
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
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 coronavirus outbreak;
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 18,
2021, 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
|
|
|
As
of
|
|
|
|
June
30,
|
|
|
December
31,
|
|
|
|
2021
|
|
|
2020
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
7,923
|
|
|
$
|
6,947
|
|
Restricted
Cash
|
|
|
113
|
|
|
|
113
|
|
Short-term
deposits
|
|
|
1,809
|
|
|
|
3,807
|
|
Marketable debt
securities
|
|
|
41,333
|
|
|
|
40,132
|
|
Other
receivables
|
|
|
487
|
|
|
|
812
|
|
Total current
assets
|
|
|
51,665
|
|
|
|
51,811
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
497
|
|
|
|
394
|
|
Property and
equipment, net
|
|
|
163
|
|
|
|
176
|
|
Total non-current
assets
|
|
|
660
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
52,325
|
|
|
$
|
52,381
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
5,629
|
|
|
$
|
7,046
|
|
Other
payables
|
|
|
1,379
|
|
|
|
966
|
|
Total current
liabilities
|
|
|
7,008
|
|
|
|
8,012
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
318
|
|
|
$
|
216
|
|
Total non-current
liabilities
|
|
|
318
|
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized
50,000,000; Issued and outstanding: 25,083,914 shares as of
June 30, 2021; 21,325,975 shares as of December 31, 2020
|
|
|
70
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
197,829
|
|
|
|
179,530
|
|
Accumulated other
comprehensive gain
|
|
|
108
|
|
|
|
272
|
|
Accumulated
deficit
|
|
|
(153,008)
|
|
|
|
(135,707)
|
|
Total
stockholders' equity
|
|
|
44,999
|
|
|
|
44,153
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
52,325
|
|
|
$
|
52,381
|
|
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,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Research and
development expenses
|
|
|
7,036
|
|
|
|
4,971
|
|
|
|
14,416
|
|
|
|
10,521
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,376
|
|
|
|
845
|
|
|
|
3,128
|
|
|
|
1,757
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
8,412
|
|
|
|
5,816
|
|
|
|
17,544
|
|
|
|
12,278
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
(16)
|
|
|
|
(290)
|
|
|
|
(243)
|
|
|
|
(689)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
8,396
|
|
|
$
|
5,526
|
|
|
$
|
17,301
|
|
|
$
|
11,589
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.33
|
|
|
$
|
0.26
|
|
|
$
|
0.72
|
|
|
$
|
0.55
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used
in computing basic and diluted net loss per share
|
|
|
25,083,914
|
|
|
|
21,153,166
|
|
|
|
24,099,132
|
|
|
|
21,152,003
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Six months
ended
|
|
|
|
June
30,
|
|
|
|
2021
|
|
|
2020
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,301)
|
|
|
$
|
(11,589)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
21
|
|
|
|
19
|
|
Stock-based
compensation expense
|
|
|
943
|
|
|
|
1,096
|
|
Amortization of
premium on marketable debt securities
|
|
|
126
|
|
|
|
16
|
|
Interest income from
short-term deposits
|
|
|
(7)
|
|
|
|
(268)
|
|
Gain from realization
of marketable debt securities
|
|
|
(19)
|
|
|
|
(10)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease in other
accounts receivable
|
|
|
325
|
|
|
|
158
|
|
Decrease in trade
payables
|
|
|
(1,417)
|
|
|
|
(2,123)
|
|
Increase (decrease)
in other accounts payable
|
|
|
412
|
|
|
|
(141)
|
|
Net cash used in
operating activities
|
|
|
(16,917)
|
|
|
|
(12,842)
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(8)
|
|
|
|
(5)
|
|
Investment in
available for sale securities
|
|
|
(7,831)
|
|
|
|
(26,979)
|
|
Sale (investment) in
short term deposits, net
|
|
|
2,005
|
|
|
|
(4,000)
|
|
Maturity of short
term deposits
|
|
|
-
|
|
|
|
4,800
|
|
Consideration from
sale of available for sale securities
|
|
|
6,359
|
|
|
|
28,588
|
|
Net cash provided
by (used in) investing activities
|
|
|
525
|
|
|
|
2,404
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of options (*)
|
|
|
(*)
|
|
|
|
61
|
|
Issuance of Ordinary
shares, net of issuance cost
|
|
|
17,368
|
|
|
|
-
|
|
Net cash provided
in financing activities
|
|
|
17,368
|
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
976
|
|
|
|
(10,377)
|
|
Cash and cash
equivalents and restricted cash at the beginning of the
period
|
|
|
7,060
|
|
|
|
16,043
|
|
Cash and cash
equivalents and restricted cash at the end of the
period
|
|
$
|
8,036
|
|
|
$
|
5,666
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
347
|
|
|
$
|
317
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
530
|
|
|
$
|
35
|
|
(*) Represents amount less than $1.
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SOURCE Galmed Pharmaceuticals Ltd.