TEL AVIV, Israel, Nov. 8, 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, provides today updated information on the Company's
scientific and clinical development programs and reports financial
results for the three and nine months ended September 30, 2021.
Recent Clinical & Scientific Developments
- Announced positive results of the efficacy of a higher daily
Aramchol dose on fibrosis improvement of the first 16 patients in
the ARMOR study Open Label Part. Data published as a late breaking
abstract at the Liver Meeting organized by the American Association
for the Study of Liver Diseases (AASLD) and will be featured in the
December issue of the scientific journal Hepatology -
- Announced histology data from first 20 patients from the ARMOR
study Open Label Part showing that treatment with Aramchol 300mg
BID resulted in clinically significant greater histological
improvement in 12 out of 20 (60%) of patients. Data is corroborated
by biomarkers associated with liver fibrosis including ALT, AST,
Fib-4 and ProC-3 in ~50 patient providing the potential to predict
similar histology response in larger cohort -
- Results of Phase 2b ARREST Trial
of Aramchol Published in Nature Medicine –
- FDA and MHRA Agree with Galmed's plan to use Aramchol meglumine
in the randomized double-blind placebo-controlled part of the Phase
3 ARMOR study —
Financial Summary – Third Quarter 2021 vs. Third Quarter
2020:
- Cash and cash equivalents, restricted cash and marketable debt
securities totaled $42.0 million as
of September 30, 2021, compared to
$50.9 million at December 31, 2020.
- Net loss amounted to $7.7
million, or $0.31 per share,
for the three months ended September 30,
2021, compared to a net loss of $6.9
million, or $0.32 per share,
for the three months ended September 30,
2020.
- Research and development expenses amounted to approximately
$6.5 million for the three months
ended September 30, 2021, compared to
approximately $6.5 million for the
three months ended September 30,
2020.
- General and administrative expenses amounted to approximately
$1.3 million for the three months
ended September 30, 2021, compared to
approximately $1.1 million for the
three months ended September 30,
2020.
- Financial income, net amounted to $0.1
million for the three months ended September 30, 2021, compared to financial income,
net of $0.7 million for the three
months ended September 30, 2020.
Conference Call &
Webcast:
Monday November 8,
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: 13724243
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1511856&tp_key=e9490761d4
Replay Dial-In Numbers
Toll Free:
1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13724243
Replay Start: Monday November 8,
2021, 11:30 AM ET
Replay Expiry: Monday November 22,
2021, 11:59 PM ET
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.
About ARMOR Study
ARMOR is a Phase 3 study comprised of two-parts, an open-label
part and a randomized, double-controlled, placebo part, designed to
evaluate the safety and efficacy of Aramchol in approximately 200
sites in the U.S., Europe and
Latin America.
The first part, an open-label study, is designed to evaluate
treatment response kinetics, pharmacokinetics and safety of twice
daily administration of Aramchol 300mg in approximately 150
subjects with NASH and liver fibrosis stage 1-3 (F1 capped at 30
subjects), subjects with NASH who may or may not be overweight, and
subjects with NASH who may or may not have type 2 diabetes or be
pre-diabetic. Patients are randomized (1:1:1) into three groups
with post-baseline liver biopsy being performed at 24 weeks, 48
weeks, or 72 weeks, respectively. A second post-baseline liver
biopsy will be conducted after one year for subjects whose
post-baseline liver biopsy at week 24, 48 or 72 does not show at
least one stage improvement in fibrosis. The open label part is
being conducted at approximately 50 selected sites in the U.S., and
around the world which have been less affected by the COVID-19
pandemic.
The second part, a randomized, double-blind, placebo-controlled
study, is designed to evaluate the safety and efficacy of twice
daily administration of Aramchol 300 mg to support regulatory
approval, with both a histology-based phase and a clinically-based
phase. As currently designed, a total of 2000 subjects with NASH
and liver fibrosis stage 2 and 3 who are overweight and are either
pre-diabetic or have type 2 diabetes are expected to be randomized
2:1 to receive Aramchol 300mg BID or matching placebo. In the
histology-based phase, we intend to treat 1000 subjects with
Aramchol or matching placebo for 72 weeks until the second biopsy.
The histology-based data is intended to serve as the basis for the
submission of a Sub-part H marketing authorization application
under regulatory provisions of accelerated/conditional approval.
The primary histology-based endpoint is NASH resolution without
worsening of fibrosis or fibrosis improvement without NASH
worsening. In the clinically-based phase, all subjects will
continue with the same treatment assignment for up to seven years
until study completion to confirm clinical efficacy. We may
announce end-of-study at the time when a total of 380 subjects have
experienced at least one pre-specified clinical event or at five
years from last subject randomization, whichever comes first. The
primary clinically-based endpoint is expected to be based on
clinical events including all-cause mortality, histological
progression to cirrhosis, MELD score >15, and hepatic
decompensation events (e.g., hepatic encephalopathy, variceal
bleeding, ascites).
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
September
30,
|
|
|
As of
December 31,
|
|
|
|
2021
|
|
|
2020
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
3,490
|
|
|
$
|
6,947
|
|
Restricted
Cash
|
|
|
113
|
|
|
|
113
|
|
Short-term
deposits
|
|
|
-
|
|
|
|
3,807
|
|
Marketable debt
securities
|
|
|
38,415
|
|
|
|
40,132
|
|
Other
receivables
|
|
|
1,674
|
|
|
|
812
|
|
Total current
assets
|
|
|
43,692
|
|
|
|
51,811
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
452
|
|
|
|
394
|
|
Property and
equipment, net
|
|
|
154
|
|
|
|
176
|
|
Total non-current
assets
|
|
|
606
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
44,298
|
|
|
$
|
52,381
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
$
|
5,233
|
|
|
$
|
7,046
|
|
Other
payables
|
|
|
1,115
|
|
|
|
966
|
|
Total current
liabilities
|
|
|
6,348
|
|
|
|
8,012
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
$
|
274
|
|
|
$
|
216
|
|
Total non-current
liabilities
|
|
|
274
|
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized
50,000,000; Issued and outstanding: 25,083,914 shares as of
September 30, 2021; 21,325,975 shares as of December 31,
2020
|
|
|
70
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
198,403
|
|
|
|
179,530
|
|
Accumulated other
comprehensive gain
|
|
|
(75)
|
|
|
|
272
|
|
Accumulated
deficit
|
|
|
(160,722)
|
|
|
|
(135,707)
|
|
Total
stockholders' equity
|
|
|
37,676
|
|
|
|
44,153
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
|
44,298
|
|
|
$
|
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
September 30,
|
|
|
Nine months
ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
Research and
development expenses
|
|
|
6,541
|
|
|
|
6,536
|
|
|
|
20,957
|
|
|
|
17,057
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
1,304
|
|
|
|
1,054
|
|
|
|
4,432
|
|
|
|
2,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
7,845
|
|
|
|
7,590
|
|
|
|
25,389
|
|
|
|
19,868
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial income,
net
|
|
|
(131)
|
|
|
|
(685)
|
|
|
|
(374)
|
|
|
|
(1,374)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
7,714
|
|
|
$
|
6,905
|
|
|
$
|
25,015
|
|
|
$
|
18,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.31
|
|
|
$
|
0.32
|
|
|
$
|
1.02
|
|
|
$
|
0.87
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic and diluted
net loss per share
|
|
|
25,083,914
|
|
|
|
21,268,730
|
|
|
|
24,432,220
|
|
|
|
21,191,196
|
|
GALMED
PHARMACEUTICALS LTD.
Consolidated Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
Nine months
ended
September 30,
|
|
|
|
2021
|
|
|
2020
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(25,015)
|
|
|
$
|
(18,494)
|
|
|
|
|
|
|
|
|
|
|
Adjustments
required to reconcile net loss to net cash used in
operating activities
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
32
|
|
|
|
28
|
|
Stock-based
compensation expense
|
|
|
1,517
|
|
|
|
1,474
|
|
Amortization of
premium on marketable debt securities
|
|
|
115
|
|
|
|
36
|
|
Interest income from
short-term deposits
|
|
|
7
|
|
|
|
(268)
|
|
Gain from realization
of marketable debt securities
|
|
|
(32)
|
|
|
|
(522)
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Decrease (increase)
in other accounts receivable
|
|
|
(862)
|
|
|
|
185
|
|
Decrease in trade
payables
|
|
|
(1,813)
|
|
|
|
(848)
|
|
Increase (decrease)
in other accounts payable
|
|
|
149
|
|
|
|
(40)
|
|
Net cash used in
operating activities
|
|
|
(25,902)
|
|
|
|
(18,449)
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(10)
|
|
|
|
(33)
|
|
Investment in
available for sale securities
|
|
|
(12,069)
|
|
|
|
(45,226)
|
|
Sale (investment) in
short term deposits, net
|
|
|
-
|
|
|
|
17,783
|
|
Maturity of short
term deposits
|
|
|
3,800
|
|
|
|
-
|
|
Consideration from
sale of available for sale securities
|
|
|
13,356
|
|
|
|
45,875
|
|
Net cash provided
by (used in) investing activities
|
|
|
5,077
|
|
|
|
18,399
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
Proceeds from
exercise of options (*)
|
|
|
|
(*)
|
|
|
61
|
|
Issuance of Ordinary
shares upon ATM
|
|
|
8,147
|
|
|
|
707
|
|
Issuance of Ordinary
shares, net of issuance cost
|
|
|
9,221
|
|
|
|
-
|
|
Net cash provided
in financing activities
|
|
|
17,368
|
|
|
|
768
|
|
|
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
(3,457)
|
|
|
|
718
|
|
Cash and cash
equivalents and restricted cash at the beginning of the
period
|
|
|
7,060
|
|
|
|
16,043
|
|
Cash and cash
equivalents and restricted cash at the end of the
period
|
|
$
|
3,603
|
|
|
$
|
16,761
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
474
|
|
|
$
|
966
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liability from adoption of ASU
2016-02
|
|
$
|
497
|
|
|
$
|
35
|
|
(*) Represents amount
less than $1.
|
Logo -
http://mma.prnewswire.com/media/595923/Galmed_Pharmaceuticals_Ltd_Logo.jpg
View original content to download
multimedia:https://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-additional-positive-data-from-the-open-label-part-of-armor-study-and-reports-third-quarter-2021-financial-results-301418394.html
SOURCE Galmed Pharmaceuticals Ltd.