TEL AVIV, Israel, March 12, 2020 /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 clinical trial for the treatment of nonalcoholic
steatohepatitis (NASH) and fibrosis provides today a business
update and reports financial results for the three and twelve
months ended December 31, 2019. The
Company will host a conference call and webcast at 08:30 ET today.
Financial Summary – Full Year
2019 vs. Full Year
2018; 4Q19
vs. 4Q18:
- For the three and twelve months ended December 31, 2019, the Company
recorded a net loss of $8.3 and
$20.5 million or $0.39 and
$0.97 per share, respectively,
compared with a net loss of $3.7 million and
$9.9 million, or $0.18 and
$0.54 per share, for the three and
twelve months ended December 31,
2018.
- Research and development expenses were $18.2 million for the twelve months
ended December 31, 2019, compared
with $8.3 million for the twelve
months ended December 31, 2018. For
the three months ended December 31,
2019, research and development expenses totaled $7.4 million, which compares with $2.7 million for the same period in 2018. The
increase during the three and twelve months is mainly due
to the preparation and initiation of the ARMOR study.
- The Company incurred general and administrative expenses of
$4.2 million for the twelve months
ended December 31, 2019, compared
with $4.4 million for the twelve
months ended December 31, 2018. For
the three months ended December 31,
2018, general and administrative expenses totaled
$1.3 million, which compares with
$1.5 million for the same period in
2018. The decrease primarily resulted from a decrease in salaries
and benefits expenses of approximately $0.5
million due to lower year-end bonuses.
- During the three and twelve months ended December 31, 2019, the Company recognized a net
financial income of $0.3 million and
$1.9 million, respectively, compared
with $0.5 and $0.9 million, respectively, during 2018. The
increase during the twelve months ended December 31, 2019 is mainly due to an increase in
interest income from marketable debt securities and short-term
deposits, as compared to such income in 2018.
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $75.6
million as of December 31,
2019, compared with $90.2 million as of
December 31, 2018. The decrease is
mainly attributable to our $14.9
million negative cash flow from operations during the
twelve months ended December 31, 2019.
Conference Call & Webcast:
Thursday, March
12th @ 8:30am Eastern
Time.
Toll Free:
|
1-877-425-9470
|
Toll/International:
|
1-201-389-0878
|
Israel Toll
Free:
|
1-809-406-247
|
Conference
ID:
|
13699345
|
Webcast:
|
http://public.viavid.com/index.php?id=138184
|
Replay Dial-In Numbers
Toll Free:
|
1-844-512-2921
|
Toll/International:
|
1-412-317-6671
|
Replay Pin
Number:
|
13699345
|
Replay
Start:
|
Thursday, March 12,
2020, 11:30 AM ET
|
Replay
Expiry:
|
Thursday, March 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.
Forward-Looking Statements:
his 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; 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 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 (Audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December
31,
|
|
|
|
|
|
2019
|
|
|
2018
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
$
|
15,931
|
|
|
$
|
24,159
|
|
Restricted
cash
|
|
|
|
|
112
|
|
|
|
-
|
|
Short-term
deposits
|
|
|
|
|
27,938
|
|
|
|
6,067
|
|
Marketable debt
securities
|
|
|
|
|
31,622
|
|
|
|
59,962
|
|
Other accounts
receivable
|
|
|
|
|
827
|
|
|
|
218
|
|
Total current
assets
|
|
|
|
|
76,430
|
|
|
|
90,406
|
|
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
|
|
538
|
|
|
|
-
|
|
Property and
equipment, net
|
|
|
|
|
171
|
|
|
|
194
|
|
Total non-current
assets
|
|
|
|
|
709
|
|
|
|
194
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
|
$
|
77,139
|
|
|
$
|
90,600
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
|
$
|
5,999
|
|
|
$
|
1,814
|
|
Other accounts
payable
|
|
|
|
|
935
|
|
|
|
892
|
|
Total current
liabilities
|
|
|
|
|
6,934
|
|
|
|
2,706
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
|
|
$
|
352
|
|
|
$
|
-
|
|
Total non-current
liabilities
|
|
|
|
|
352
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share; Authorized
50,000,000 shares; Issued and outstanding: 21,139,385 shares
as of December 31, 2019; 21,018,919 shares as of December
31, 2018
|
|
|
|
|
58
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
|
|
176,696
|
|
|
|
174,322
|
|
Accumulated other
comprehensive income (loss)
|
|
|
|
|
35
|
|
|
|
(11)
|
|
Accumulated
deficit
|
|
|
|
|
(106,936)
|
|
|
|
(86,475)
|
|
Total
stockholders' equity
|
|
|
|
|
69,853
|
|
|
|
87,894
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
|
|
$
|
77,139
|
|
|
$
|
90,600
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Operations (Audited)
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
|
2019
|
|
|
2018
|
|
|
2017
|
|
Revenue
|
$
|
-
|
|
|
$
|
2,038
|
|
|
$
|
1,085
|
|
Research and
development expenses
|
|
18,180
|
|
|
|
8,313
|
|
|
|
9,650
|
|
General and
administrative expenses
|
|
4,196
|
|
|
|
4,440
|
|
|
|
3,799
|
|
Total operating
loss
|
|
22,376
|
|
|
|
10,715
|
|
|
|
12,364
|
|
Financial income,
net
|
|
(1,915)
|
|
|
|
(934)
|
|
|
|
(65)
|
|
Loss before income
taxes
|
|
20,461
|
|
|
|
9,781
|
|
|
|
12,299
|
|
Income
taxes
|
|
-
|
|
|
|
75
|
|
|
|
-
|
|
Net
loss
|
$
|
20,461
|
|
|
$
|
9,856
|
|
|
$
|
12,299
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
0.97
|
|
|
$
|
0.54
|
|
|
$
|
0.98
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per share
|
|
21,114,399
|
|
|
|
18,137,689
|
|
|
|
12,487,349
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Cash Flows (Audited)
|
U.S. Dollars in
thousands
|
|
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
|
|
2019
|
|
|
2018
|
|
|
2017
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
year
|
|
$
|
(20,461)
|
|
|
$
|
(9,856)
|
|
|
$
|
(12,299)
|
|
Adjustments
required to reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
35
|
|
|
|
387
|
|
|
|
239
|
|
Amortization of
discount/premium on marketable debt securities
|
|
|
(105)
|
|
|
|
(144)
|
|
|
|
21
|
|
Loss (gain) on sale
of marketable debt securities
|
|
|
(9)
|
|
|
|
12
|
|
|
|
143
|
|
Linked difference of
marketable debt securities
|
|
|
-
|
|
|
|
-
|
|
|
|
(167)
|
|
Interest income from
short-term deposits
|
|
|
(63)
|
|
|
|
-
|
|
|
|
-
|
|
Stock-based
compensation expense
|
|
|
2,231
|
|
|
|
1,783
|
|
|
|
1,394
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in deferred
revenue from collaboration agreement
|
|
|
-
|
|
|
|
(538)
|
|
|
|
(1,085)
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(609)
|
|
|
|
(63)
|
|
|
|
129
|
|
Increase (decrease)
in trade payables
|
|
|
4,185
|
|
|
|
(462)
|
|
|
|
(846)
|
|
Increase
(decrease) in other accounts payable
|
|
|
(141)
|
|
|
|
(142)
|
|
|
|
671
|
|
Increase (decrease)
in related party
|
|
|
-
|
|
|
|
-
|
|
|
|
(267)
|
|
Net cash used in
operating activities
|
|
|
(14,937)
|
|
|
|
(9,023)
|
|
|
|
(12,067)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(12)
|
|
|
|
(90)
|
|
|
|
(12)
|
|
Investment in
securities, available for sale
|
|
|
(72,600)
|
|
|
|
(92,279)
|
|
|
|
(3,869)
|
|
Proceeds from sale of
securities, available for sale
|
|
|
101,098
|
|
|
|
38,421
|
|
|
|
10,325
|
|
Investment in
short-term deposits, net
|
|
|
(21,808)
|
|
|
|
(6,067)
|
|
|
|
–
|
|
Net cash provided
by (used in) investing activities
|
|
|
6,678
|
|
|
|
(60,015)
|
|
|
|
6,444
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares and warrants, net of issuance costs (*)
|
|
|
-
|
|
|
|
79,149
|
|
|
|
15,017
|
|
Proceeds from
exercise of options
|
|
|
143
|
|
|
|
1,027
|
|
|
|
530
|
|
Net cash provided
by financing activities
|
|
|
143
|
|
|
|
80,176
|
|
|
|
15,547
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
(8,116)
|
|
|
|
11,138
|
|
|
|
9,924
|
|
Cash and cash
equivalents and restricted cash at the beginning of the
year
|
|
|
24,159
|
|
|
|
13,021
|
|
|
|
3,097
|
|
Cash and cash
equivalents and restricted cash at the end of the
year
|
|
$
|
16,043
|
|
|
$
|
24,159
|
|
|
$
|
13,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
1,953
|
|
|
$
|
865
|
|
|
$
|
202
|
|
Cash paid for
taxes
|
|
$
|
-
|
|
|
$
|
75
|
|
|
$
|
–
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liabilities from adoption of ASU
2016-02
|
|
$
|
653
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
View original content to download
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SOURCE Galmed Pharmaceuticals Ltd.