TEL AVIV, Israel, May 7, 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 and
fibrosis, provides today updated information on the Company's
clinical development program and reports financial results for the
three months ended March 31, 2019.
The Company will host a conference call and webcast at 08:30 ET today.
Business Update
Completion of End of Phase 2 Meeting With FDA
In April 2019, the Company
announced that it completed its End-of-Phase 2 meeting with the
Food and Drug Administration (FDA) and reached general agreement on
key aspects of the Phase 3/4 development and registration plan for
Aramchol and on the pivotal registration study ARMOR. General
agreement has been reached with FDA on key aspects of the ARMOR
study including patient population, study endpoints, study dose and
treatment duration.
Updates on the ARMOR study design
The planned Phase 3/4 ARMOR study is a multi-national,
multi-center, randomized, double blind, placebo-controlled study
designed to evaluate the efficacy and safety of Aramchol as
compared to placebo in subjects with NASH and fibrosis. The ARMOR
study will enroll subjects with pre-diabetes or type II diabetes,
overweight or obese and a baseline fibrosis score of 2-3. The study
is designed to consist of two parts. In the first part
(histology-based) subjects will be treated with Aramchol or
matching placebo for 52 weeks until the second biopsy. In the
second part (clinically-based), subjects will continue with the
same treatment assignment until study completion to confirm
clinical efficacy. Assuming the results in the first part are
positive, the Company plans to submit a marketing authorization
application under regulatory provisions of accelerated/conditional
approval.
The ARMOR study will evaluate the safety and efficacy of
Aramchol and is expected to enroll approximately 2000 patients
dosed with 300mg of Aramchol twice daily or placebo in a 2:1
randomization ratio. The Company plans to perform an analysis of
the primary histology-based endpoints after the first 1,200
patients complete 52 weeks of treatment. The trial is being powered
to meet the two alternative key histology-based endpoints: (i) NASH
resolution without worsening of liver fibrosis, and (ii) fibrosis
improvement without NASH worsening. Under FDA guidance, meeting one
of these endpoints is expected to suffice for the study success of
the first part
The Company plans on opening around 150 recruiting sites around
the globe including in the U.S., Europe, Latin
America and Asia.
The Company is on track to submit its study protocol and other
design elements of its ARMOR trial to the FDA this quarter with
study commencement expected in the third quarter of 2019. Following
commencement, the Company anticipates completion of randomization
within 18 months and based on current timelines the Company aims to
report the results of the first part of the study in the fourth
quarter of 2022.
Financial Summary - First Quarter 2019 vs. First Quarter
2018:
- Cash and cash equivalents, short-term deposits and marketable
debt securities totalled $86.6
million as of March 31, 2019,
compared to $90.2 million at
December 31, 2018.
- Net loss amounted to $3.5
million, or $0.17 per share,
for the three months ended March 31,
2019, compared to a net loss of $2.5
million, or $0.17 per share,
for the three months ended March 31,
2019.
- Research and development expenses amounted to approximately
$3.3 million for the three months
ended March 31, 2019, compared to
approximately $1.9 million for the
three months ended March 31, 2018.
The increase resulted primarily from an increase in expenses in
connection with the manufacturing of Aramchol for the ARMOR
study.
- General and administrative expenses amounted to approximately
$0.8 million for the three months
ended March 31, 2019, compared to
approximately $0.9 million for the
three months ended March 31, 2018.
The decrease in general and administrative expenses for the three
months ended March 31, 2019 resulted
primarily from a decrease in professional fees.
- Financial income, net amounted to $0.5
million for the three months ended March 31, 2019, compared to financial income, net
of $0.1 million for the three months
ended March 31, 2018. The increase
primarily relates to an increase in financial income from financial
assets.
Conference Call & Webcast:
Tuesday, May 7th @
8:30am Eastern
Time.
Within the
US:
1-855-327-6837
Outside the
US:
1-631-891-4304
Israel Toll
Free:
1 809 458 327
Conference
ID:
10006680
Webcast: http://public.viavid.com/index.php?id=134310
Replay Dial-In Numbers
Toll
Free:
1-844-512-2921
Toll/International:
1-412-317-6671
Replay Pin
Number:
10006680
Replay
Start: Tuesday
May 7, 2019, 11:30 AM ET
Replay
Expiry: Tuesday
May 21, 2019, 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 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 2b 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 to initiate a Phase 3/4 clinical
study in the third quarter of 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 pivotal Phase 3/4 ARMOR trial, or the ARMOR Study or
whether a pivotal trial will be conducted at all; 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 13,
2019, 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
March
31,
2019
|
|
|
As of
December 31,
2018
|
|
|
|
Unaudited
|
|
|
Audited
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
37,338
|
|
|
$
|
24,159
|
|
Short-term
deposits
|
|
|
6,112
|
|
|
|
6,067
|
|
Marketable debt
securities
|
|
|
43,112
|
|
|
|
59,962
|
|
Other accounts
receivable
|
|
|
417
|
|
|
|
218
|
|
Total current
assets
|
|
|
86,979
|
|
|
|
90,406
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
668
|
|
|
|
-
|
|
Property and
equipment, net
|
|
|
189
|
|
|
|
194
|
|
Total
non-current assets
|
|
|
857
|
|
|
|
194
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
87,836
|
|
|
$
|
90,600
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
1,797
|
|
|
$
|
1,814
|
|
Other accounts
payable
|
|
|
612
|
|
|
|
892
|
|
Total current
liabilities
|
|
|
2,409
|
|
|
|
2,706
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
499
|
|
|
$
|
-
|
|
Total non-current
liabilities
|
|
|
499
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding: 21,113,066 shares as of March 31, 2019;
21,018,919 shares as of December 31, 2018
|
|
|
58
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
174,812
|
|
|
|
174,322
|
|
Accumulated other
comprehensive gain (loss)
|
|
|
25
|
|
|
|
(11)
|
|
Accumulated
deficit
|
|
|
(89,967)
|
|
|
|
(86,475)
|
|
Total
stockholders' equity
|
|
|
84,928
|
|
|
|
87,894
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
87,836
|
|
|
$
|
90,600
|
|
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,
|
|
|
|
2019
|
|
|
2018
|
|
Revenue
|
|
$
|
-
|
|
|
$
|
268
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
3,269
|
|
|
|
1,944
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
771
|
|
|
|
883
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
4,040
|
|
|
|
2,559
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
(548)
|
|
|
|
(53)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
3,492
|
|
|
$
|
2,506
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share from continuing operation
|
|
$
|
0.17
|
|
|
$
|
0.17
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic and diluted
net loss per share
|
|
|
21,084,329
|
|
|
|
14,467,627
|
|
GALMED
PHARMACEUTICALS LTD.
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
|
|
|
Three months
ended
March
31,
|
|
|
|
2019
|
|
|
2018
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(3,492)
|
|
|
$
|
(2,506)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
9
|
|
|
|
59
|
|
Stock-based
compensation expense
|
|
|
416
|
|
|
|
330
|
|
Amortization of
discount (premium) on marketable debt securities
|
|
|
(39)
|
|
|
|
9
|
|
Interest income from
short-term deposits
|
|
|
(45)
|
|
|
|
-
|
|
Loss (gain) from
realization of marketable debt securities
|
|
|
(5)
|
|
|
|
3
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Increase in other
accounts receivable
|
|
|
(199)
|
|
|
|
(210)
|
|
Decrease in trade
payables
|
|
|
(17)
|
|
|
|
(80)
|
|
Decrease in other
accounts payable
|
|
|
(449)
|
|
|
|
(802)
|
|
Decrease in deferred
revenue
|
|
|
-
|
|
|
|
(268)
|
|
Net cash used in
operating activities
|
|
|
(3,821)
|
|
|
|
(3,465)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(4)
|
|
|
|
(1)
|
|
Investment in
available for sale securities
|
|
|
(48,717)
|
|
|
|
(8,185)
|
|
Consideration from
sale of available for sale securities
|
|
|
65,647
|
|
|
|
1,249
|
|
Net cash provided
in (used in) investing activities
|
|
|
16,926
|
|
|
|
(6,937)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of options
|
|
|
74
|
|
|
|
12
|
|
Net cash provided
in financing activities
|
|
|
74
|
|
|
|
12
|
|
|
|
|
|
|
|
|
|
|
Decrease
(increase) in cash and cash equivalents
|
|
|
13,179
|
|
|
|
(10,390)
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
24,159
|
|
|
|
13,021
|
|
Cash and cash
equivalents at the end of the period
|
|
$
|
37,338
|
|
|
$
|
2,631
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
535
|
|
|
$
|
46
|
|
Non-cash
transactions
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
679
|
|
|
$
|
-
|
|
View original
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SOURCE Galmed Pharmaceuticals Ltd.