TEL AVIV, Israel, May 14, 2020 /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, 2020.
The Company will host a conference call and webcast at 08:30 ET today.
Galmed announces significant progress in the development of
Aramchol meglumine, a salt version of Aramchol which has higher
solubility, the same ADME profile, and is expected to have less
variability in human plasma. Aramchol meglumine is considered a New
Chemical Entity. As such, it is eligible for NCE patent protection
until December 2034. Patents have
been granted and maintained in 37 European territories, in
Japan, Australia, China and Canada. Discussions on the patent protection
in the USA with the USPTO are
ongoing.
Results from a single and multiple oral administration doses of
Aramchol free acid and Aramchol meglumine in a cross over PK study
in dogs, demonstrated bioequivalence with reduced variability. In
particular:
- after single dose administration, the AUCs Aramchol free acid
and Aramchol meglumine are almost identical;
- after multiple dosing (steady state) AUC for the Aramchol
meglumine was higher compared to Aramchol free acid;
- a three-fold reduction in coefficient variation in steady state
in the Aramchol meglumine arm compared to Aramchol free acid
suggesting lower variability among patients receiving Aramchol
meglumine in the future;
- half-life of Aramchol while administration of both Aramchol
free acid and Aramchol meglumine is identical in single and
multiple dosing (steady state); and
- Cmax was higher in Aramchol meglumine compared to Aramchol free
acid in steady state.
Galmed plans to submit these results along with other supportive
data to the FDA and discuss with the FDA, as soon as practical, a
plan to appropriately transition from Aramchol free acid to the
Aramchol meglumine in the ongoing ARMOR Phase 3 study. Based on
Galmed's regulatory and scientific review of relevant FDA guidance
and precedents, the Company's assessment is that this change during
Phase 3 could be considered acceptable provided bioequivalence of
the two products is established and a number of other data
considerations are addressed.
"Over the last few years, Galmed has been in the process of
developing a new product, Aramchol meglumine, which is a salt form
of Aramchol free acid. It is important to note that Aramchol
meglumine and Aramchol acid circulate as Aramchol regardless of
which drug product is administered. The markedly higher solubility
of Aramchol meglumine results in lower variability which is a
significant added benefit. We are excited to share with you today
this important development. By developing a salt version of
Aramchol we are able to take the important step towards
gaining patent protection on the drug until December 2034. We have long understood the
importance of securing a meaningful period of patent protected
opportunity for our drug as we plan for our Phase 3 and beyond,"
said Allen Baharaff, Chief Executive Officer of Galmed.
Galmed plans on holding a virtual Analyst's Day in the coming
months to discuss the details of this program.
Response to COVID-19
Galmed continues to monitor the impact of the COVID-19 pandemic
on its operations and is committed to ensuring the health, safety
and well-being of its clinical study participants, staff at its
study sites and employees.
- Galmed implemented remote working and workplace protocols for
our employees in accordance with Israeli Ministry of Health
requirements;
- Galmed decided to temporarily halt the screening of new
patients for the ARMOR study and aims to resume activity on a
country by country, state by state and site by site basis as
conditions improve;
- Galmed has utilized this time to advance the opening of new
sites so that they are ready for activation when screening and
randomization will be possible; and
- To help mitigate cost overrun, Galmed has taken several cost
reduction measures including minimizing clinical related expenses,
making certain adjustments to clinical staff pay according to the
current and predicted level of activity, and reducing directors'
cash fees by 50% for the first half of 2020.
During the second quarter of 2020, Galmed expects to lift some
of the constraints in states in the US identified as "green states"
allowing individual investigators to determine whether it is safe
to resume screening activities. Galmed's current assessment is that
by the fourth quarter of 2020, it will be able to resume
recruitment in most of the ARMOR study sites. Accordingly, Galmed
is updating its guidance for completion of recruitment of patients
for the first part of the study from the second quarter of 2021 to
the fourth quarter of 2021 and reporting of top-line results for
the first part of the study from the fourth quarter of 2022 to the
second half of 2023. The rapid development and fluidity of the
COVID-19 pandemic precludes any firm estimates as to the ultimate
effect this disease will have on the ARMOR study and is subject to
change.
Financial Summary – First Quarter 2020 vs. First
Quarter 2019:
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $69.0
million as of March 31, 2020,
compared to $75.6 million at
December 31, 2019.
- Net loss amounted to $6.1
million, or $0.29 per share,
for the three months ended March 31,
2020, compared to a net loss of $3.5
million, or $0.17 per share,
for the three months ended March 31,
2020.
- Research and development expenses amounted to approximately
$5.6 million for the three months
ended March 31, 2020, compared to
approximately $3.3 million for the
three months ended March 31, 2019.
The increase resulted primarily from an increase in clinical trial
expenses in connection with our ongoing ARMOR study.
- General and administrative expenses amounted to approximately
$0.9 million for the three months
ended March 31, 2020, compared to
approximately $0.8 million for the
three months ended March 31, 2019.
The increase in general and administrative expenses for the three
months ended March 31, 2020 resulted
primarily from an increase in non-cash stock-based compensation
expenses.
- Financial income, net amounted to $0.4
million for the three months ended March 31, 2020, compared to financial income, net
of $0.5 million for the three months
ended March 31, 2019. The decrease
primarily relates to a decrease in financial income from financial
assets.
Conference Call & Webcast:
Thursday, May 14th @ 8:30am Eastern
Time.
|
Within the
US:
|
1-877-425-9470
|
Outside the
US:
|
1-201-389-0878
|
Israel Toll
Free:
|
1-809-406-247
|
Conference
ID:
|
13702167
|
Webcast:
|
http://public.viavid.com/index.php?id=139176
|
|
|
Replay Dial-In
Numbers
|
Toll
Free:
|
1-844-512-2921
|
Toll/International:
|
1-412-317-6671
|
Replay Pin
Number:
|
13702167
|
Replay
Start:
|
Thursday May 14,
2020, 11:30 AM ET
|
Replay
Expiry:
|
Thursday May 28,
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:
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; completion and
receiving favorable results of the ARMOR Study for Aramchol or any
other pre-clinical or clinical trial; the impact of the coronavirus
outbreak; 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
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
As of
March
31,
2020
|
|
|
As of
December 31,
2019
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
13,316
|
|
|
$
|
15,931
|
|
Restricted
Cash
|
|
|
113
|
|
|
|
112
|
|
Short-term
deposits
|
|
|
32,106
|
|
|
|
27,938
|
|
Marketable debt
securities
|
|
|
23,467
|
|
|
|
31,622
|
|
Other accounts
receivable
|
|
|
790
|
|
|
|
827
|
|
Total current
assets
|
|
|
69,792
|
|
|
|
76,430
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
486
|
|
|
|
538
|
|
Property and
equipment, net
|
|
|
161
|
|
|
|
171
|
|
Total non-current
assets
|
|
|
647
|
|
|
|
709
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
70,439
|
|
|
$
|
77,139
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
5,330
|
|
|
$
|
5,999
|
|
Other accounts
payable
|
|
|
703
|
|
|
|
935
|
|
Total current
liabilities
|
|
|
6,033
|
|
|
|
6,934
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
302
|
|
|
$
|
352
|
|
Total non-current
liabilities
|
|
|
302
|
|
|
|
352
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000; Issued and
outstanding:
21,153,166 shares as
of March 31, 2020; 21,139,385 shares as of December 31,
2019
|
|
|
58
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
177,272
|
|
|
|
176,696
|
|
Accumulated other
comprehensive gain (loss)
|
|
|
(227)
|
|
|
|
35
|
|
Accumulated
deficit
|
|
|
(112,999)
|
|
|
|
(106,936)
|
|
Total
stockholders' equity
|
|
|
64,104
|
|
|
|
69,853
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
70,439
|
|
|
$
|
77,139
|
|
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,
|
|
|
|
2020
|
|
|
2019
|
|
Research and
development expenses
|
|
$
|
5,550
|
|
|
$
|
3,269
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
912
|
|
|
|
771
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
6,462
|
|
|
|
4,040
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
(399)
|
|
|
|
(548)
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
6,063
|
|
|
$
|
3,492
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share from continuing operation
|
|
$
|
0.29
|
|
|
$
|
0.17
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic and diluted
net loss per share
|
|
|
21,150,841
|
|
|
|
21,084,329
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Three months
ended
March
31,
|
|
|
|
2020
|
|
|
2019
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(6,063)
|
|
|
$
|
(3,492)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
10
|
|
|
|
9
|
|
Stock-based
compensation expense
|
|
|
515
|
|
|
|
416
|
|
Amortization of
premium on marketable debt securities
|
|
|
(9)
|
|
|
|
(39)
|
|
Interest income from
short-term deposits
|
|
|
(168)
|
|
|
|
(45)
|
|
Gain from realization
of marketable debt securities
|
|
|
(11)
|
|
|
|
(5)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Increase (decrease)
in other accounts receivable
|
|
|
37
|
|
|
|
(199)
|
|
Decrease in trade
payables
|
|
|
(669)
|
|
|
|
(17)
|
|
Decrease in other
accounts payable
|
|
|
(230)
|
|
|
|
(449)
|
|
Net cash used in
operating activities
|
|
|
(6,588)
|
|
|
|
(3,821)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
-
|
|
|
|
(4)
|
|
Investment in
available for sale securities
|
|
|
(7,400)
|
|
|
|
(48,717)
|
|
Investment in short
term deposits
|
|
|
(4,000)
|
|
|
|
|
|
Consideration from
sale of available for sale securities
|
|
|
15,313
|
|
|
|
65,647
|
|
Net cash provided
in investing activities
|
|
|
3,913
|
|
|
|
16,926
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of options
|
|
|
61
|
|
|
|
74
|
|
Net cash provided
in financing activities
|
|
|
61
|
|
|
|
74
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents
|
|
|
(2,614)
|
|
|
|
13,179
|
|
Cash and cash
equivalents at the beginning of the period
|
|
|
16,043
|
|
|
|
24,159
|
|
Cash and cash
equivalents at the end of the period
|
|
$
|
13,429
|
|
|
$
|
37,338
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
168
|
|
|
$
|
535
|
|
|
|
|
|
|
|
|
|
|
View original content to download
multimedia:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-update-and-reports-first-quarter-2020-financial-results-301059265.html
SOURCE Galmed Pharmaceuticals Ltd.