TEL AVIV, Israel, Nov. 5, 2018 /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, a once-daily, oral
therapy for the treatment of nonalcoholic steatohepatitis, or NASH,
today provides a business update and reports financial results
for the three and nine months ended September 30, 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 pivotal study of Aramchol
The Company is planning to initiate the ARMOR, Phase 3 pivotal
study of Aramchol at the end of the second quarter of 2019 or
early in the third quarter of 2019. Manufacturing of the first
batch of the Phase 3 active pharmaceutical ingredients is due
to be completed during the fourth quarter of 2018. Selection of the
regions and countries where the study will be conducted has been
completed and specific site feasibility is in process. The Company
is working on advancing the regulatory submissions process.
Appointment of a new member to the
Board
In October 2018, Marshall Heinberg was appointed to the Board of
Directors. Mr. Heinberg currently serves as a Senior Advisor
to Burford Capital, a leading publicly traded litigation finance
company. Mr. Heinberg also serves as Executive Chairman of the
Board of Ecology and Environment, a Nasdaq-listed environmental
consulting firm. Until July 2012, he
was Head of Investment Banking at Oppenheimer & Co., Inc. and
was formerly Head of U.S. Investment Banking for CIBC World
Markets. Over the course of his career, Mr. Heinberg has been
responsible for managing corporate finance, mergers and
acquisitions, leveraged finance, financial sponsors and merchant
banking activity in the United States.
Key appointments to clinical operation team
- In September, 2018, Ronen
Mansuri, was appointed Vice President, Clinical Operations
and Biometrics reporting to Dr. Tali Gorfine, Chief Medical
Officer. Prior to joining Galmed, Mr. Mansuri spent 12 years in
various senior positions in Teva Pharmaceutical's Biometrics, Data
Management and Operations Management, most recently as Senior
Director, Head of Global Clinical Data Programming and holding key
positions in Teva Global R&D.
- In November, 2018, Dr. Jonathan Yovell, was appointed as
Medical Director, reporting to Dr. Gorfine. Prior to joining Galmed
Dr. Yovell was Medical Manager Oncology at Merck Serono Ltd. in
Israel where he was responsible
for the clinical plan and led the scientific and clinical
activities related to Merck's portfolio of oncology drugs in
Israel.
Financial Summary - Third Quarter 2018 vs. Third Quarter
2017:
- Cash and cash equivalents, short term deposits and marketable
debt securities totaled $92.3 million
as of September 30, 2018, compared to
$19.0 million at 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.
- Net loss of $1.0 million, or
($0.05) per share, for the three
months ended September 30, 2018,
compared to a net loss of $2.8
million, or ($0.23) per share,
for the three months ended September 30,
2018.
- The Company recognized $1.5
million of revenue for the three months ended September 30, 2018, compared to approximately
$0.3 million for the three months
ended September 30, 2017. The revenue
relates to a milestone payment received under the license agreement
with Samil Pharma.
- Research and development expenses amounted to approximately
$1.7 million for the three months
ended September 30, 2018, compared to
approximately $2.3 million for the
three months ended September 30,
2017. The decrease resulted primarily from a decrease in
expenses in connection with clinical studies.
- General and administrative expenses amounted to approximately
$1.0 million for the three months
ended September 30, 2018, compared to
approximately $0.7 million for the
three months ended September 30,
2017. The increase in general and administrative expenses
for the three months ended September 30,
2018 resulted primarily from an increase in non-cash stock
based compensation expenses.
- Financial income amounted to $0.3
million for the three months ended September 30, 2018, compared to a financial
income of $0.01 million for the three
months ended September 30, 2017. The
increase primarily relates to an increase in financial income from
marketable securities.
Conference Call & Webcast:
Monday, November 5 @
8:30am Eastern Time
Within the US: 800-239-9838
Outside the
US: 323-794-2551
From Israel: 1809 212 883
Conference ID: 9320949
Webcast:
http://public.viavid.com/index.php?id=131686
Replays, Available through November
19:
Domestic: 844-512-2921
International: 412-317-6671
Replay PIN: 9320949
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, once-daily,
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 IIb meeting with the FDA to discuss
the results of the ARREST Study and a Phase III study protocol,
with a view to initiating a Phase III 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
|
|
|
As of
|
|
|
|
September
30,
|
|
|
December 31,
|
|
|
|
2018
|
|
|
2017
|
|
|
|
Unaudited
|
|
|
Audited
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
25,983
|
|
|
$
|
13,021
|
|
Marketable debt
securities
|
|
|
60,313
|
|
|
|
5,976
|
|
Short-term
deposits
|
|
|
6,021
|
|
|
|
-
|
|
Other accounts
receivable
|
|
|
286
|
|
|
|
155
|
|
Total current
assets
|
|
|
92,603
|
|
|
|
19,152
|
|
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
284
|
|
|
|
491
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
92,887
|
|
|
$
|
19,643
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
1,288
|
|
|
$
|
2,276
|
|
Other accounts
payable
|
|
|
851
|
|
|
|
1,034
|
|
Short-term portion of
deferred revenue
|
|
|
-
|
|
|
|
538
|
|
Total current
liabilities
|
|
|
2,139
|
|
|
|
3,848
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued
and
outstanding: 21,003,828 shares as of September 30, 2018; 14,435,161
shares as of
December 31, 2017
|
|
|
58
|
|
|
|
40
|
|
Additional paid-in
capital
|
|
|
173,469
|
|
|
|
92,381
|
|
Accumulated other
comprehensive loss
|
|
|
(10)
|
|
|
|
(7)
|
|
Accumulated
deficit
|
|
|
(82,769)
|
|
|
|
(76,619)
|
|
Total stockholders'
equity
|
|
|
90,748
|
|
|
|
15,795
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
92,887
|
|
|
$
|
19,643
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Operations (Unaudited)
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
Three months ended
|
|
|
Nine months ended
|
|
|
|
September
30,
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Revenue
|
|
$
|
1,500
|
|
|
$
|
273
|
|
|
$
|
2,038
|
|
|
$
|
811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
1,693
|
|
|
|
2,331
|
|
|
|
5,577
|
|
|
|
7,421
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
987
|
|
|
|
697
|
|
|
|
2,975
|
|
|
|
2,110
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
loss
|
|
|
1,180
|
|
|
|
2,755
|
|
|
|
6,514
|
|
|
|
8,720
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income), net
|
|
|
(296)
|
|
|
|
46
|
|
|
|
(439)
|
|
|
|
(65)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
884
|
|
|
|
2,801
|
|
|
|
6,075
|
|
|
|
8,655
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
|
75
|
|
|
|
-
|
|
|
|
75
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
959
|
|
|
$
|
2,801
|
|
|
$
|
6,150
|
|
|
$
|
8,655
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.05
|
|
|
$
|
0.23
|
|
|
$
|
0.36
|
|
|
$
|
0.71
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per
share
|
|
|
20,953,421
|
|
|
|
12,364,249
|
|
|
|
17,167,911
|
|
|
|
12,274,536
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Cash Flows (Unaudited)
|
|
U.S. Dollars in
thousands
|
|
|
|
|
|
Nine months
ended
|
|
|
|
September
30,
|
|
|
|
2018
|
|
|
2017
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,150)
|
|
|
$
|
(8,655)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
261
|
|
|
|
180
|
|
Stock-based
compensation expense
|
|
|
1,045
|
|
|
|
1,066
|
|
Amortization of
discount/premium on marketable debt securities
|
|
|
(81)
|
|
|
|
(187)
|
|
Interest from
short-term deposits
|
|
|
(21)
|
|
|
|
-
|
|
Loss from Realization
of marketable debt securities
|
|
|
13
|
|
|
|
130
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(131)
|
|
|
|
113
|
|
Decrease in trade
payables
|
|
|
(988)
|
|
|
|
(1,157)
|
|
Decrease in other
accounts payable
|
|
|
(183)
|
|
|
|
(144)
|
|
Decrease in related
party
|
|
|
-
|
|
|
|
(117)
|
|
Decrease in deferred
revenue
|
|
|
(538)
|
|
|
|
(812)
|
|
Net cash used in
operating activities
|
|
|
(6,773)
|
|
|
|
(9,583)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(53)
|
|
|
|
(10)
|
|
Investment in
available for sale securities
|
|
|
(88,180)
|
|
|
|
(1,447)
|
|
Investment in short
term deposits
|
|
|
(6,000)
|
|
|
|
7,589
|
|
Consideration from
sale of available for sale securities
|
|
|
33,907
|
|
|
|
-
|
|
Net cash provided
in (used in) investing activities
|
|
|
(60,326)
|
|
|
|
(6,132)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Issuance of Ordinary
Shares and warrants *)
|
|
|
79,118
|
|
|
|
2,655
|
|
Proceeds from
exercise of options
|
|
|
943
|
|
|
|
313
|
|
Net cash provided
in financing activities
|
|
|
80,061
|
|
|
|
2,968
|
|
|
|
|
|
|
|
|
|
|
Increase in cash
and cash equivalents
|
|
|
12,962
|
|
|
|
(483)
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
13,021
|
|
|
|
3,097
|
|
Cash and cash
equivalents at the end of the period
|
|
$
|
25,983
|
|
|
$
|
2,614
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
513
|
|
|
|
169
|
|
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SOURCE Galmed Pharmaceuticals Ltd.