TEL
AVIV, Israel, May 17, 2022
/PRNewswire/ —Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed"
or the "Company"), a clinical-stage biopharmaceutical company for
liver, metabolic, fibrosis and inflammatory diseases reports
financial results for the three months ended March 31, 2022.
Recent Developments
- Announced that Company's clinical development strategy will
expand into new anti-fibrotic indications to maximize the potential
of its lead compound, Aramchol while at the same time discontinuing
the Open Label Part of the Armor Study having reached its
objectives.
- Company evaluating its strategic alternatives and its
structuring to best enhance shareholder value and achieve its
goals.
Financial Summary – First Quarter 2022 vs. First Quarter
2021:
- Cash and cash equivalents, restricted cash and marketable debt
securities totaled $28.9 million as
of March 31, 2022, compared to
$34.9 million at December 31, 2021.
- Net loss amounted to $6.1
million, or $0.24 per share,
for the three months ended March 31,
2022, compared to a net loss of $8.9
million, or $0.38 per share,
for the three months ended March 31,
2021.
- Research and development expenses amounted to approximately
$4.8 million for the three months
ended March 31, 2022, compared to
approximately $7.4 million for the
three months ended March 31, 2021.
The decrease resulted primarily from a decrease in drug development
expenses.
- General and administrative expenses amounted to approximately
$1.3 million for the three months
ended March 31, 2022, compared to
approximately $1.8 million for the
three months ended March 31, 2021.
The decrease in general and administrative expenses for the three
months ended March 31, 2021 resulted
primarily from a decrease in salaries and benefits.
- Financial expense, net amounted to $0.05
million for the three months ended March 31, 2022, compared to financial income, net
of $0.2 million for the three months
ended March 31, 2021.
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 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 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; Galmed's expectations regarding
licensing, acquisitions and strategic operations; and the outcome
of any evaluation of Galmed's strategic alternatives. 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
May 2, 2022, 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
|
|
|
March
31,
|
|
December
31,
|
|
|
2022
|
2021
|
|
|
Unaudited
|
Audited
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
3,741
|
$
|
2,884
|
Restricted
Cash
|
|
114
|
|
114
|
Marketable debt
securities
|
|
25,001
|
|
31,931
|
Other
receivable
|
|
843
|
|
1,125
|
Total current
assets
|
|
29,699
|
|
36,054
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
361
|
|
406
|
Property and equipment,
net
|
|
136
|
|
145
|
Total non-current
assets
|
|
497
|
|
551
|
|
|
|
|
|
|
|
|
Total
assets
|
$
|
30,196
|
$
|
36,605
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Trade
payables
|
$
|
4,835
|
$
|
4,871
|
Other
payables
|
|
812
|
|
1,008
|
Total current
liabilities
|
|
5,647
|
|
5,879
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
Lease
obligation
|
$
|
183
|
$
|
229
|
Total non-current
liabilities
|
|
183
|
|
229
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding:
|
|
|
|
|
|
|
|
25,088,414 shares as of
March 31, 2022 and December 31, 2021
|
|
70
|
|
70
|
Additional paid-in
capital
|
|
199,229
|
|
198,772
|
Accumulated other
comprehensive loss
|
|
(616)
|
|
(171)
|
Accumulated
deficit
|
|
(174,317)
|
|
(168,174)
|
Total stockholders'
equity
|
|
24,366
|
|
30,497
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
30,196
|
$
|
36,605
|
The accompanying notes
are an integral part of the interim consolidated financial
statements.
|
|
|
|
|
|
|
|
|
|
|
|
|
GALMED PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Operations (Unaudited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
Three months
ended
|
|
|
March
31,
|
|
|
2022
|
|
2021
|
Research and
development expenses
|
$
|
4,796
|
$
|
7,380
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
1,296
|
|
1,752
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
6,092
|
|
9,132
|
|
|
|
|
|
|
|
|
|
Financial expense
(income), net
|
|
51
|
|
(227)
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
6,143
|
$
|
8,905
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
0.24
|
$
|
0.38
|
Weighted-average number
of shares outstanding used in computing basic and diluted net loss
per
share
|
|
25,088,414
|
|
23,374,061
|
|
|
|
|
|
|
|
|
|
GALMED PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
Three months
ended
|
|
March
31,
|
|
2022
|
2022
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(6,143)
|
$
|
|
(8,905)
|
|
|
|
|
|
|
|
|
|
|
Adjustments required
to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
9
|
|
|
11
|
Stock-based
compensation expense
|
|
457
|
|
|
471
|
Amortization of premium
on marketable debt securities
|
|
31
|
|
|
21
|
Interest income from
short-term deposits
|
|
-
|
|
|
(4)
|
Loss (Gain) from
realization of marketable debt securities
|
|
145
|
|
|
15
|
Finance
expenses
|
|
(10)
|
|
|
-
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
Decrease in other
accounts receivable
|
|
282
|
|
|
28
|
Decrease in trade
payables
|
|
(36)
|
|
|
(1,243)
|
Increase (decrease) in
other accounts payable
|
|
(187)
|
|
|
320
|
Net cash used in
operating activities
|
|
(5,452)
|
|
|
(9,286)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
-
|
|
|
(1)
|
Investment in available
for sale securities
|
|
-
|
|
|
(10,007)
|
Sale (investment) in
short term deposits, net
|
|
-
|
|
|
2,005
|
Consideration from sale
of available for sale securities
|
|
6,309
|
|
|
6,359
|
Net cash provided by
(used in) investing activities
|
|
6,309
|
|
|
(1,644)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
Proceeds from exercise
of options (*)
|
|
-
|
|
|
(*)
|
Issuance of Ordinary
shares, net of issuance cost
|
|
-
|
|
|
17,368
|
Net cash provided in
financing activities
|
|
-
|
|
|
17,368
|
|
|
|
|
|
|
Increase (decrease)
in cash and cash equivalents and restricted cash
|
|
857
|
|
|
6,438
|
Cash and cash
equivalents and restricted cash at the beginning of the
period
|
|
2,998
|
|
|
7,060
|
Cash and cash
equivalents and restricted cash at the end of the
period
|
$
|
3,855
|
$
|
|
13,498
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
$
|
77
|
$
|
|
179
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
$
|
-
|
$
|
|
497
|
|
(*) Represents amount
less than $1.
|
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content:https://www.prnewswire.com/news-releases/galmed-pharmaceuticals-reports-first-quarter-2022-financial-results-301548816.html
SOURCE Galmed Pharmaceuticals Ltd.