TEL AVIV, Israel, May 13, 2021 /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, reports financial results for the three months ended
March 31, 2021. The Company will host
a conference call and webcast at 08:30
ET today.
Recent Clinical & Scientific Developments
- Histology Results from approximately one-third of the study
population (~ 50 subjects) of the open label part of the ARMOR
Phase 3 study with higher exposure of Aramchol are expected to be
available in Q4 2021.
- The National Medical Products Administration (NMPA) has granted
approval for the Investigational New Drug (IND) application for the
ARMOR Phase 3 study of Aramchol for the treatment of NASH &
fibrosis in China.
- Submitted to the FDA the results of the Aramchol meglumine
Phase I study with a view to introducing Aramchol meglumine into
the double-blind placebo controlled registrational part of the
ARMOR Phase 3 study. Galmed is expecting to receive guidance from
the FDA in Q3 2021 and initiate the double-blind part of the ARMOR
Phase 3 study by the end of Q1 2022.
- Completed single administrated doses from 10mg to 180mg in
first in human Phase I trial of Amilo-5-Mer. Following excellent
safety and proportional PK, single dosing ascended to 360mg.
Topline data is expected in second half of 2021 and a Phase
1b proof of concept study is planned
for Q4 2021.
Financial Summary – First Quarter 2021 vs. First Quarter
2020:
- During February 2021, Galmed
raised approximately $18.4 million in
an underwritten public offering and from its at-the-market equity
facility.
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $58.9
million as of March 31, 2021,
compared to $50.9 million at
December 31, 2020.
- Net loss amounted to $8.9 million, or $0.38 per share, for the three
months ended March 31, 2021, compared
to a net loss of $6.1 million, or
$0.29 per share, for the three months
ended March 31, 2020.
- Research and development expenses amounted to approximately
$7.4 million for the
three months ended March 31, 2021,
compared to approximately $5.6
million for the three months ended March 31, 2020. The increase resulted primarily
from an increase in drug development expenses in connection with
the manufacturing of Aramchol API to support the ARMOR Study and
the development of Aramchol meglumine.
- General and administrative expenses amounted to approximately
$1.7 million for the three months
ended March 31, 2021, compared to
approximately $0.9 million for the
three months ended March 31, 2020.
The increase in general and administrative expenses for the three
months ended March 31, 2021 resulted
primarily from an increase in salaries and benefits, and as well
from an increase in the cost of our D&O insurance policy
premium.
- Financial income, net amounted to $0.2 million for the three months
ended March 31, 2021, compared to
financial income, net of $0.4 million
for the three months ended March 31,
2020.
Conference Call & Webcast:
Thursday May 13, 2021,
8:30 AM ET
Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406
247
Conference ID: 13719139
Webcast:
http://public.viavid.com/index.php?id=144593
Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13719139
Replay Start: Thursday May 13,
2021, 11:30 AM ET
Replay Expiry: Thursday May 27,
2021, 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. We are also collaborating with
the Hebrew University in the development of Amilo-5MER, a
5 amino acid synthetic peptide and recently initiated a first in
human study.
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 the COVID-19 pandemic; 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; 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 18, 2021, 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
|
|
|
|
|
March
31,
|
|
|
December
31,
|
|
|
|
|
2021
|
|
|
2020
|
|
|
|
|
Unaudited
|
|
|
Audited
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
13,385
|
|
|
$
|
6,947
|
|
|
Restricted
Cash
|
|
|
113
|
|
|
|
113
|
|
|
Short-term
deposits
|
|
|
1,806
|
|
|
|
3,807
|
|
|
Marketable debt
securities
|
|
|
43,614
|
|
|
|
40,132
|
|
|
Other
receivable
|
|
|
784
|
|
|
|
812
|
|
|
Total current
assets
|
|
|
59,702
|
|
|
|
51,811
|
|
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
509
|
|
|
|
394
|
|
|
Property and
equipment, net
|
|
|
166
|
|
|
|
176
|
|
|
Total non-current
assets
|
|
|
675
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
60,377
|
|
|
$
|
52,381
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
5,803
|
|
|
$
|
7,046
|
|
|
Other
payables
|
|
|
1,334
|
|
|
|
966
|
|
|
Total current
liabilities
|
|
|
7,137
|
|
|
|
8,012
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
283
|
|
|
$
|
216
|
|
|
Total non-current
liabilities
|
|
|
283
|
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding:
|
|
|
|
|
|
|
|
|
|
25,083,914 shares as
of March 31, 2021; 21,325,975 shares as of December 31,
2020
|
|
|
70
|
|
|
|
58
|
|
|
Additional paid-in
capital
|
|
|
197,357
|
|
|
|
179,530
|
|
|
Accumulated other
comprehensive gain
|
|
|
142
|
|
|
|
272
|
|
|
Accumulated
deficit
|
|
|
(144,612)
|
|
|
|
(135,707)
|
|
|
Total
stockholders' equity
|
|
|
52,957
|
|
|
|
44,153
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
60,377
|
|
|
$
|
52,381
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
|
|
|
|
|
|
2021
|
|
|
|
2020
|
|
Research and
development expenses
|
|
$
|
|
7,380
|
|
$
|
|
5,550
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
|
1,752
|
|
|
|
912
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
|
9,132
|
|
|
|
6,462
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
|
(227)
|
|
|
|
(399)
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
|
8,905
|
|
$
|
|
6,063
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
|
0.38
|
|
$
|
|
0.29
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic
|
|
|
|
|
|
|
|
|
|
and diluted net loss
per share
|
|
|
|
23,374,061
|
|
|
|
21,150,841
|
|
|
|
|
|
|
|
|
|
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
|
|
Consolidated
Statements of Cash Flows (Unaudited)
|
|
U.S. Dollars in
thousands
|
|
|
|
|
|
|
|
Three months ended
|
|
|
|
March
31,
|
|
|
|
2021
|
|
2020
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(8,905)
|
|
$
|
(6,063)
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
11
|
|
|
10
|
|
Stock-based
compensation expense
|
|
|
471
|
|
|
515
|
|
Amortization of
premium (discount) on marketable debt securities
|
|
|
21
|
|
|
(9)
|
|
Interest income from
short-term deposits
|
|
|
(4)
|
|
|
(168)
|
|
Gain from realization
of marketable debt securities
|
|
|
15
|
|
|
(11)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
Decrease in other
accounts receivable
|
|
|
28
|
|
|
37
|
|
Increase (decrease)
in trade payables
|
|
|
(1,243)
|
|
|
(669)
|
|
Decrease in other
accounts payable
|
|
|
320
|
|
|
(230)
|
|
Net cash used in
operating activities
|
|
|
(9,286)
|
|
|
(6,588)
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(1)
|
|
|
-
|
|
Investment in
available for sale securities
|
|
|
(10,007)
|
|
|
(7,400)
|
|
Sale (investment) in
short term deposits, net
|
|
|
2,005
|
|
|
(4,000)
|
|
Consideration from
sale of available for sale securities
|
|
|
6,359
|
|
|
15,313
|
|
Net cash provided
by investing activities
|
|
|
(1,644)
|
|
|
3,913
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of options
|
|
|
(*)
|
|
|
61
|
|
|
|
|
|
|
|
|
|
Issuance of Ordinary
shares, net of issuance cost
|
|
|
17,368
|
|
|
-
|
|
Net cash provided
in financing activities
|
|
|
17,368
|
|
|
61
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
6,438
|
|
|
(2,614)
|
|
Cash and cash
equivalents and restricted cash at the beginning of the period
Cash
|
|
|
7,060
|
|
|
16,043
|
|
Cash equivalents
and restricted cash at the end of the period
|
|
$
|
13,498
|
|
$
|
13,429
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
179
|
|
$
|
168
|
|
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
497
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
(*) Represents amount
less than $1.
|
|
|
|
|
|
|
|
View original
content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-updates-and-reports-first-quarter-2021-financial-results-301290818.html
SOURCE Galmed Pharmaceuticals Ltd.