TEL
AVIV, Israel, Aug. 4, 2022
/PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD)
("Galmed" or the "Company"), a clinical-stage biopharmaceutical
company focused on the development of Aramchol™, an oral therapy
for the treatment of nonalcoholic steatohepatitis, or NASH,
fibrosis and other fibrotic indications, provides today a business
update and reports financial results for the three and six months
ended June 30, 2022.
Recent Developments
- Discontinuing the Open Label Part of the ARMOR study having
reached its objectives while refocusing research and development on
advancing Aramchol for new anti-fibrotic indications.
- Implementing a cost reduction plan that includes reduction in
headcount and full-time positions and discontinuing any
non-essential research and development activities.
- Evaluating the continuation of development of Aramchol and
Amilo-5MER and unable to estimate if and when the registrational
part of the ARMOR study will be initiated.
- Continuing to explore strategic alternatives and structuring to
best optimize resources to enhance shareholder value and achieve
goals.
Financial Summary – Second Quarter 2022 vs. Second Quarter
2021:
- Cash and cash equivalents, restricted cash and marketable debt
securities totaled $22.5 million as
of June 30, 2022, compared to
$34.9 million at December 31, 2021.
- Net loss amounted to $3.7
million, or $0.15 per share,
for the three months ended June 30,
2022, compared to a net loss of $8.4
million, or $0.33 per share,
for the three months ended June 30,
2021.
- Research and development expenses amounted to approximately
$2.6 million for the three months
ended June 30, 2022, compared to
approximately $7.0 million for the
three months ended June 30, 2021. The
decrease resulted primarily from a decrease in clinical trial
expenses in connection with the discontinuation of the Open Label
Part of the ARMOR study.
- General and administrative expenses amounted to approximately
$1.1 million for the three months
ended June 30, 2022, compared to
approximately $1.4 million for the
three months ended June 30, 2021. The
decrease in general and administrative expenses for the three
months ended June 30, 2022 resulted
primarily from a decrease in professional services expenses.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development
biopharmaceutical company for liver, metabolic and inflammatory
diseases.
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 COVID-19; 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; Galmed's ability
to maintain the listing of its common stock on The Nasdaq Capital
Market; 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.
Logo -
https://mma.prnewswire.com/media/1713483/Galmed_Pharmaceuticals_Logo.jpg
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,
|
|
|
|
2022
|
|
|
2021
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
1,980
|
|
|
|
2,884
|
|
Restricted
Cash
|
|
|
114
|
|
|
|
114
|
|
Marketable debt
securities
|
|
|
20,422
|
|
|
|
31,931
|
|
Other
receivable
|
|
|
614
|
|
|
|
1,125
|
|
Total current
assets
|
|
|
23,130
|
|
|
|
36,054
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
315
|
|
|
|
406
|
|
Property and equipment,
net
|
|
|
130
|
|
|
|
145
|
|
Total non-current
assets
|
|
|
445
|
|
|
|
551
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
23,575
|
|
|
$
|
36,605
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
2,089
|
|
|
$
|
4,871
|
|
Other accounts
payables
|
|
|
640
|
|
|
|
1,008
|
|
Total current
liabilities
|
|
|
2,729
|
|
|
|
5,879
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, net of current portion
|
|
$
|
134
|
|
|
$
|
229
|
|
Total non-current
liabilities
|
|
|
134
|
|
|
|
229
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 300,000,000;
Issued and outstanding:
|
|
|
|
|
|
|
|
|
25,088,414 shares as of
June 30, 2022 and December 31, 2021
|
|
|
70
|
|
|
|
70
|
|
Additional paid-in
capital
|
|
|
199,675
|
|
|
|
198,772
|
|
Accumulated other
comprehensive loss
|
|
|
(982)
|
|
|
|
(171)
|
|
Accumulated
deficit
|
|
|
(178,051)
|
|
|
|
(168,174)
|
|
Total stockholders'
equity
|
|
|
20,712
|
|
|
|
30,497
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
23,575
|
|
|
$
|
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
|
|
|
Six months
ended
|
|
|
|
June
30,
|
|
|
June
30,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Research and
development expenses
|
|
|
2,580
|
|
|
|
7,036
|
|
|
|
7,376
|
|
|
|
14,416
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,150
|
|
|
|
1,376
|
|
|
|
2,446
|
|
|
|
3,128
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
3,730
|
|
|
|
8,412
|
|
|
|
9,822
|
|
|
|
17,544
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expense
(income), net
|
|
|
4
|
|
|
|
(16)
|
|
|
|
55
|
|
|
|
(243)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
3,374
|
|
|
$
|
8,396
|
|
|
$
|
9,877
|
|
|
$
|
17,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.15
|
|
|
$
|
0.33
|
|
|
$
|
0.39
|
|
|
$
|
0.72
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number
of shares outstanding used in
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
computing basic and
diluted net loss per share
|
|
|
25,088,414
|
|
|
|
25,083,914
|
|
|
|
25,088,414
|
|
|
|
24,099,132
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Six months
ended
|
|
|
|
June
30,
|
|
|
|
2022
|
|
|
2021
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(9,877)
|
|
|
$
|
(17,301)
|
|
|
|
|
|
|
|
|
|
|
Adjustments required
to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
18
|
|
|
|
21
|
|
Stock-based
compensation expense
|
|
|
903
|
|
|
|
943
|
|
Amortization of premium
on marketable debt securities
|
|
|
35
|
|
|
|
126
|
|
Interest income from
short-term deposits
|
|
|
-
|
|
|
|
(7)
|
|
Loss (gain) from
realization of marketable debt securities
|
|
|
201
|
|
|
|
(19)
|
|
Finance
expenses
|
|
|
(42)
|
|
|
|
-
|
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease in other
accounts receivable
|
|
|
511
|
|
|
|
325
|
|
Decrease in trade
payables
|
|
|
(2,782)
|
|
|
|
(1,417)
|
|
Increase (decrease) in
other accounts payable
|
|
|
(330)
|
|
|
|
412)
|
|
Net cash used in
operating activities
|
|
|
(11,363)
|
|
|
|
(16,917)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(3)
|
|
|
|
(8)
|
|
Investmentin available
for sale securities
|
|
|
|
|
|
|
(7,831)
|
|
Sale (investment) in
short term deposits, net
|
|
|
-
|
|
|
|
2,005
|
|
Consideration from sale
of available for sale securities
|
|
|
10,462
|
|
|
|
6,359
|
|
Net cash provided by
(used in) investing activities
|
|
|
10,459
|
|
|
|
525
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
(904)
|
|
|
|
976
|
|
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
|
|
$
|
2,094
|
|
|
$
|
8,036
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
138
|
|
|
$
|
347
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
Right-of-use assets
obtained in exchange for new operating lease liabilities,
net
|
|
$
|
-
|
|
|
$
|
530
|
|
(*) Represents amount less than $1.
View original
content:https://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-update-and-reports-second-quarter-2022-financial-results-301599992.html
SOURCE Galmed Pharmaceuticals Ltd.