TEL AVIV, Israel, March 13, 2019 /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,
today reported financial results for the three and twelve
months ended December 31, 2018. The Company will host a
conference call and webcast at 08:30
ET today.
Business Update
Updates on progress towards the initiation of "ARMOR",
Aramchol's Phase 3/4 pivotal study of Aramchol
The Company is scheduled to meet the FDA for its end of Phase
2b meeting later this month with the
aim of initiating the ARMOR, Phase 3/4 pivotal study of Aramchol at
the end of the second quarter of 2019 or early in the third
quarter of 2019. The Company plans to discuss with the FDA its
planned clinical trial design for the ARMOR study and the results
of its recently announced dose splitting PK study.
Preparations for the commencement of the study are ongoing.
Dose Splitting Pharmacokinetic (PK)
Study
The Company recently conducted a Phase I, open-label,
two-period, randomized, crossover PK study to assess whether dose
splitting of Aramchol 600mg to twice daily 300mg will significantly
increase plasma levels. Results of the study showed that the
administration of Aramchol 300 mg twice daily resulted in 24-hour
plasma concentrations significantly greater than those observed
with the administration of Aramchol 600 mg once daily.
(P<0.0001). The average plasma levels (exposure) were 53% higher
and exposure was greater in all 16 subjects with the twice daily
dosing. The treatment in both dosing regimens were similar in terms
of safety and were well tolerated.
Phase 2b Data Presented During
Late-Breaking Abstract Oral Session of The Liver Meeting®
2018
In November 2019, an oral abstract
presentation of the one-year results of the Company's Phase
2b ARREST study of Aramchol in NASH
was presented at the Late Breaking Abstract Oral Session at The
Liver Meeting® 2018 during the American Association for the Study
of Liver Diseases 2018 Annual Meeting in San Francisco.
Financial Summary – Full Year 2018 vs. Full Year 2017;
4Q18vs. 4Q17:
- For the three and twelve months ended December 31, 2018, the Company recorded a net
loss of $3.7 and $9.9 million or
$0.18 and $0.54 per
share, respectively, compared with a net loss of $3.6 million and $12.3
million, or $0.27 and $0.98 per
share, for the three and twelve months ended December 31, 2017.
- The Company recognized
$2.0 million of revenue for
the twelve months ended December 31,
2018, compared to
$1.1 million for the same
period in 2017. This years' revenue included a
milestone payment of $1.5 million in
connection with the Company's license agreement with Samil Pharm
Co., Ltd.
- Research and development expenses were
$8.3 million for the twelve
months ended December 31, 2018,
compared with $9.7 million
for the twelve months ended December 31,
2017. For the three months ended December 31, 2018, research and development
expenses totaled $2.7 million, which compares
with $2.2 million for the
same period in 2017.
- The Company incurred general and administrative expenses of
$4.4 million for the twelve months
ended December 31, 2018, compared
with $3.8 million for the twelve
months ended December 31, 2017. For
the three months ended December 31,
2017, general and administrative expenses totaled
$1.5 million, which compares with
$1.7 million for the same period in
2017.
- During the three and twelve months ended December 31, 2018 the Company recognized a net
financial income of $0.5 million and
$0.9 million, respectively, compares
with $0.01 and $0.1 million during 2017.
- Cash and cash equivalents, short-term deposits and marketable
debt securities totaled $90.2 million as of
December 31, 2018, compared with
$19.0 million as of December 31, 2017. The increase is mainly
attributable to the approximately $70.3
million in net proceeds raised in an underwritten public
offering that was completed in June
2018, together with $5.9
million in net proceeds raised in a registered direct
offering during April 2018.
Conference Call & Webcast:
Wednesday, March 13th
@ 8:30am Eastern
Time
Within the
US: 877-425-9470
Outside the US: 201-389-0878
From Israel: 1 809 406 247
Conference ID: 13687890
Webcast: http://public.viavid.com/index.php?id=133389
A replay of the webcast will be available shortly after the live
presentation at the Company's website,
https://www.galmedpharma.com/, on the For Investors section's
Events & Presentations page and will be available for one
year.
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 is a clinical-stage biopharmaceutical company focused on
the development of Aramchol, a first in class, novel, oral therapy
for the treatment of NASH for variable populations. Galmed recently
announced top-line results of the ARREST Study, a multicenter,
randomized, double blind, placebo-controlled Phase IIb clinical
study designed to evaluate the efficacy and safety of Aramchol in
subjects with NASH, who are overweight or obese, and who are
pre-diabetic or type-II-diabetic. Galmed is currently preparing for
an end of Phase 2b meeting with the
FDA to discuss the results of the ARREST Study and a Phase 3/4
study protocol, with a view to initiating a Phase 3/4 clinical
study of Aramchol in 2019.
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
planned Phase III trial for Aramchol, or whether a Phase III trial
will be conducted at all; completion and receiving favorable
results of a Phase III trial 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; 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 13, 2018, 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 December
31,
|
|
|
|
2018
|
|
2017
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
24,159
|
|
$
|
13,021
|
|
Short-term
deposits
|
|
|
6,067
|
|
|
-
|
|
Marketable debt
securities
|
|
|
59,962
|
|
|
5,976
|
|
Other accounts
receivable
|
|
|
218
|
|
|
155
|
|
Total
current assets
|
|
|
90,406
|
|
|
19,152
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
194
|
|
|
491
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
90,600
|
|
$
|
19,643
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
1,814
|
|
|
2,276
|
|
Other accounts
payable
|
|
|
892
|
|
|
1,034
|
|
Deferred
revenue
|
|
|
-
|
|
|
538
|
|
Total
current liabilities
|
|
|
2,706
|
|
|
3,848
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share;
Authorized 50,000,000 shares;
Issued and outstanding: 21,018,919 shares as of December
31,
2018; 14,435,161 shares as of December 31, 2017
|
|
|
58
|
|
|
40
|
|
Additional paid-in
capital
|
|
|
174,322
|
|
|
92,381
|
|
Accumulated other
comprehensive loss
|
|
|
(11)
|
|
|
(7)
|
|
Accumulated
deficit
|
|
|
(86,475)
|
|
|
(76,619)
|
|
Total
stockholders' equity
|
|
|
87,894
|
|
|
15,795
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
90,600
|
|
$
|
19,643
|
|
GALMED PHARMACEUTICALS LTD.
|
|
Consolidated Statements of
Operations
|
|
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
|
|
|
|
|
2018
|
|
|
|
2017
|
|
|
|
2016
|
|
Revenue
|
|
|
|
$
|
2,038
|
|
|
$
|
1,085
|
|
|
$
|
467
|
|
Research and
development expenses
|
|
|
|
|
8,313
|
|
|
|
9,650
|
|
|
|
14,271
|
|
General and
administrative expenses
|
|
|
|
|
4,440
|
|
|
|
3,799
|
|
|
|
3,078
|
|
Total operating
loss
|
|
|
|
|
10,715
|
|
|
|
12,364
|
|
|
|
16,882
|
|
Financial income,
net
|
|
|
|
|
(934)
|
|
|
|
(65)
|
|
|
|
(35)
|
|
Loss before income
taxes
|
|
|
|
|
9,781
|
|
|
|
12,299
|
|
|
|
16,847
|
|
Income
taxes
|
|
|
|
|
75
|
|
|
|
-
|
|
|
|
106
|
|
Net
loss
|
|
|
|
$
|
9,856
|
|
|
$
|
12,299
|
|
|
$
|
16,953
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share from
continuing operations
|
|
|
|
$
|
0.54
|
|
|
$
|
0.98
|
|
|
$
|
1.49
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per
share
|
|
|
|
|
18,137,689
|
|
|
|
12,487,349
|
|
|
|
11,374,653
|
|
GALMED PHARMACEUTICALS LTD.
|
|
Consolidated Statements of Cash
Flows
|
|
|
|
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
|
2016
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
year
|
|
$
|
(9,856)
|
|
|
$
|
(12,299)
|
|
|
$
|
(16,953)
|
|
Adjustments
required to reconcile net loss to net cash used
in operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
387
|
|
|
|
239
|
|
|
|
169
|
|
Amortization of
discount/premium on marketable debt securities
|
|
|
(144)
|
|
|
|
21
|
|
|
|
44
|
|
Loss on sale of
marketable debt securities
|
|
|
12
|
|
|
|
143
|
|
|
|
231
|
|
Linked difference of
marketable debt securities
|
|
|
-
|
|
|
|
(167)
|
|
|
|
–
|
|
Stock-based
compensation expense
|
|
|
1,783
|
|
|
|
1,394
|
|
|
|
1,628
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease)
in deferred revenue from collaboration
agreement
|
|
|
(538)
|
|
|
|
(1,085)
|
|
|
|
1,623
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(63)
|
|
|
|
129
|
|
|
|
95
|
|
Increase (decrease)
in trade payables
|
|
|
(462)
|
|
|
|
(846)
|
|
|
|
863
|
|
Increase (decrease)
in other accounts payable
|
|
|
(142)
|
|
|
|
671
|
|
|
|
81
|
|
Increase (decrease)
in related party
|
|
|
-
|
|
|
|
(267)
|
|
|
|
90
|
|
Net cash used in
operating activities
|
|
|
(9,023)
|
|
|
|
(12,067)
|
|
|
|
(12,129)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(90)
|
|
|
|
(12)
|
|
|
|
(17)
|
|
Proceeds from sale of
property and equipment
|
|
|
–
|
|
|
|
–
|
|
|
|
13
|
|
Investment in
securities, available for sale
|
|
|
(92,279)
|
|
|
|
(3,869)
|
|
|
|
(7,615)
|
|
Proceeds from sale of
securities, available for sale
|
|
|
38,421
|
|
|
|
10,325
|
|
|
|
13,955
|
|
Investment in
short-term deposits
|
|
|
(6,067)
|
|
|
|
–
|
|
|
|
–
|
|
Net cash provided
by (used in) investing activities
|
|
|
(60,015)
|
|
|
|
6,444
|
|
|
|
6,336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares and warrants, net of issuance costs
|
|
|
79,149
|
|
|
|
15,017
|
|
|
|
4,479
|
|
Proceeds from
exercise of options
|
|
|
1,027
|
|
|
|
530
|
|
|
|
255
|
|
Net cash provided
by financing activities
|
|
|
80,176
|
|
|
|
15,547
|
|
|
|
4,734
|
|
Increase
(decrease) in cash and cash equivalents
|
|
|
11,138
|
|
|
|
9,924
|
|
|
|
(1,059)
|
|
Cash and cash
equivalents at the beginning of the year
|
|
|
13,021
|
|
|
|
3,097
|
|
|
|
4,156
|
|
Cash and cash
equivalents at the end of the year
|
|
$
|
24,159
|
|
|
$
|
13,021
|
|
|
$
|
3,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
865
|
|
|
$
|
202
|
|
|
$
|
382
|
|
Cash paid for
taxes
|
|
$
|
75
|
|
|
$
|
–
|
|
|
$
|
106
|
|
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SOURCE Galmed Pharmaceuticals Ltd.