TEL AVIV, Israel, March 18, 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 and twelve months
ended December 31, 2020. The Company
will host a conference call and webcast at 08:30 ET today.
Recent Clinical, Scientific & Business
Developments
- In December last year, we announced the addition of an
open-label part to our ARMOR Phase 3 registrational study designed
to evaluate the treatment response, pharmacokinetics and safety as
well as several Non-Invasive Tests (including ProC3, ELF and
Fibroscan) associated with NASH and fibrosis of twice daily
administration (BID) of Aramchol 300mg for the treatment duration
of 24, 48 and 72 weeks. Results from approximately one-third of the
study population (~ 50 subjects) that has completed the
post-baseline liver biopsy are expected to be available in Q4 2021
as planned.
- ARMOR's double blind, placebo-controlled, registrational part
is expected to initiate by the end of Q1 2022 based on once daily
administration (QD) of Aramchol meglumine 300mg which is a salt
form of Aramchol free acid with an improved target product profile.
PK data showed that Aramchol meglumine and Aramchol free acid, the
drug product that is currently being evaluated in the open label
part of ARMOR, have the same PK profile i.e. same half-life and
same Cmax and circulate in the blood as Aramchol regardless of
which drug product is administered. Furthermore, Aramchol Meglumine
has higher solubility which results in better homogeneity in blood
levels. A Type C meeting with the FDA is planned for Q2 2021 to
discuss a plan to introduce Aramchol meglumine into the
double-blind, placebo-controlled, registrational part of the ARMOR
Phase 3 study.
- A Phase 1a clinical trial of Amilo-5MER was initiated earlier
this quarter as planned for single and multiple dosing and includes
also oral dosing. Topline data is expected to be available in H2
2021. In LPS induced inflammation in mice, the animal model for
systemic inflammation, Amilo-5MER reduced IL-6, TNF a, IFN
g and IL-1b levels in the serum. Elevated levels of these
pro inflammatory cytokine is the hallmark of acute and chronic
inflammatory conditions and are symptomatic also among COVID-19
patients.
- During February 2021, Galmed raised approximately
$18.4 million in an underwritten
public offering and from its at-the-market equity facility. Galmed
intends to use the net proceeds of these offerings for the
continued development of our pipeline products, as well as the
advancement of new programs, business development activities, and
general corporate purposes.
- A new paper entitled "Aramchol Downregulates Stearoyl
CoA-Desaturase 1 (SCD1) in Hepatic Stellate Cells to Attenuate
Cellular Fibrogenesis" was published in the JHEP Reports. The paper
summarizes a longstanding research collaboration by Prof.
Scott Friedman, Chief of the
Division of Liver Diseases, Icahn School of Medicine at
Mount Sinai, New York and Prof.
Jose Mato of the Precision Medicine
and Metabolism Laboratory, CIC bioGUNE, Spain describing for the first time the role
of SCD1 in hepatic fibrogenesis and outlining the mechanism by
which Aramchol exerts its anti-fibrotic effect directly by down
regulation of SCD1 in hepatic stellate cells (HSCs). Data further
support Aramchol's role in fibrosis reversal, including the
potential antifibrotic activity in the ongoing Phase 3 ARMOR study
in patients with NASH and fibrosis.
Financial Summary – Full Year 2020 vs. Full Year 2010;
4Q20vs. 4Q19:
- For the three and twelve months ended December 31, 2020, the Company recorded a net
loss of $10.3 million and
$28.8 million or $0.48 and $1.35 per
share, respectively, compared with a net loss of $8.3 million and $20.5
million, or $0.39 and
$0.97 per share, for the three and
twelve months ended December 31,
2019.
- Research and development expenses were
$26.1 million for the twelve months ended
December 31, 2020,
compared with $18.2 million for the
twelve months ended December 31,
2019. For the three months ended December 31, 2020, research and
development expenses totalled $9.0
million, which compares with $7.4 million
for the same period in 2019.
The increase for the three and twelve months resulted primarily
from an increase in clinical trial expenses in connection with the
Company's ongoing ARMOR study as well an increase in expenses
related to CMC and formulation studies in connection with the
manufacturing of Aramchol API to support the ARMOR study and the
development of Aramchol Meglumine.
The Company incurred general and administrative expenses of
$4.1 million for the
twelve months ended December 31,
2020, compared with $4.2
million for the twelve months ended December 31, 2019. For the three months ended
December 31, 2020, general and
administrative expenses totaled $1.3
million, which compares with $1.3
million for the same period in 2019.
- The decrease for the twelve months ended December 31, 2020 primarily resulted from a
decrease in stock-based compensation expenses and professional
services, partially offset by an increase in the cost of the
Company's D&O insurance policy premium.
Financial income, net amounted to $1.4
million for the twelve months ended December
31, 2020, compared with $1.9
million for the twelve months ended December
31, 2019. For the three months ended December 31, 2020, financial income, net totaled
$0.1 million, which compares with
$0.3 million for the same period in 2019.
- Cash and cash equivalents, restricted cash, short-term deposits
and marketable debt securities totaled $51.0
million as of December 31,
2020, compared with $75.6
million as of December 31,
2019. The amount as of December 31,
2020 does not include $17.5 million of net proceeds
raised during February 2021 in an underwritten public offering
and the Company's at-the-market equity facility.
More detailed information can be found in the Company's Annual
Report on Form 20-F, a copy of which has been filed with the
Securities and Exchange Commission and posted on the Company's
website at www.galmedpharma.com. You may request a copy of the
Company's Form 20-F, at no cost to you, by writing to the Chief
Financial Officer of the Company at 16 Tiomkin Street, Tel Aviv, Israel, 6578317 or by calling
+972-3-693-8448.
Conference Call & Webcast:
Thursday, March 18,
2021, 8:30 AM Eastern
Time.
Toll Free: 1-877-425-9470
Toll/International: 1-201-389-0878
Israel Toll Free: 1 809 406
247
Conference ID: 13716813
Webcast: http://public.viavid.com/index.php?id=143695
Replay Dial-In Numbers
Toll Free: 1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13716813
Replay Start: Thursday March 18,
2021, 11:30 AM ET
Replay Expiry: Thursday April 1,
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 (Audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
As of December
31,
|
|
|
|
|
|
|
2020
|
|
|
2019
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
|
$
|
6,947
|
|
|
$
|
15,931
|
|
Restricted
cash
|
|
|
|
|
|
|
113
|
|
|
|
112
|
|
Short-term
deposits
|
|
|
|
|
|
|
3,807
|
|
|
|
27,938
|
|
Marketable debt
securities
|
|
|
|
|
|
|
40,132
|
|
|
|
31,622
|
|
Other accounts
receivable
|
|
|
|
|
|
|
812
|
|
|
|
827
|
|
Total current
assets
|
|
|
|
|
|
|
51,811
|
|
|
|
76,430
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Right of use
assets
|
|
|
|
|
|
|
394
|
|
|
|
538
|
|
Property and
equipment, net
|
|
|
|
|
|
|
176
|
|
|
|
171
|
|
Total non-current
assets
|
|
|
|
|
|
|
570
|
|
|
|
709
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
|
|
|
$
|
52,381
|
|
|
$
|
77,139
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
|
|
|
$
|
7,046
|
|
|
$
|
5,999
|
|
Other accounts
payable
|
|
|
|
|
|
|
966
|
|
|
|
935
|
|
Total current
liabilities
|
|
|
|
|
|
|
8,012
|
|
|
|
6,934
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Lease
obligation
|
|
|
|
|
|
$
|
216
|
|
|
$
|
352
|
|
Total non-current
liabilities
|
|
|
|
|
|
|
216
|
|
|
|
352
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share; Authorized 50,000,000 shares; Issued
and outstanding: 21,325,975 shares as of December 31, 2020;
21,139,385 shares as of
December 31, 2019
|
|
|
|
|
|
|
58
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
|
|
|
|
179,530
|
|
|
|
176,696
|
|
Accumulated other
comprehensive income
|
|
|
|
|
|
|
272
|
|
|
|
35
|
|
Accumulated
deficit
|
|
|
|
|
|
|
(135,707)
|
|
|
|
(106,936)
|
|
Total
stockholders' equity
|
|
|
|
|
|
|
44,153
|
|
|
|
69,853
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
|
|
|
|
$
|
52,381
|
|
|
$
|
77,139
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Operations (Audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
|
|
Year ended
December 31,
|
|
|
|
|
|
|
2020
|
|
|
2019
|
|
|
2018
|
|
Revenue
|
|
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
2,038
|
|
Research and
development expenses
|
|
|
|
|
|
26,082
|
|
|
|
18,180
|
|
|
|
8,313
|
|
General and
administrative expenses
|
|
|
|
|
|
4,128
|
|
|
|
4,196
|
|
|
|
4,440
|
|
Total operating
loss
|
|
|
|
|
|
30,210
|
|
|
|
22,376
|
|
|
|
10,715
|
|
Financial income,
net
|
|
|
|
|
|
(1,439)
|
|
|
|
(1,915)
|
|
|
|
(934)
|
|
Loss before income
taxes
|
|
|
|
|
|
28,771
|
|
|
|
20,461
|
|
|
|
9,781
|
|
Income
taxes
|
|
|
|
|
|
-
|
|
|
|
-
|
|
|
|
75
|
|
Net
loss
|
|
|
|
|
$
|
28,771
|
|
|
$
|
20,461
|
|
|
$
|
9,856
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
|
|
$
|
1.35
|
|
|
$
|
0.97
|
|
|
$
|
0.54
|
|
Weighted-average
number of shares outstanding used in
computing basic and diluted net loss per share
|
|
|
|
|
|
21,280,787
|
|
|
|
21,114,399
|
|
|
|
18,137,689
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Audited)
|
U.S. Dollars in
thousands
|
|
|
|
|
Year ended
December 31,
|
|
|
|
2020
|
|
|
2019
|
|
|
2018
|
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
year
|
|
$
|
(28,771)
|
|
|
$
|
(20,461)
|
|
|
$
|
(9,856)
|
|
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
39
|
|
|
|
35
|
|
|
|
387
|
|
Amortization of
discount/premium on marketable debt securities
|
|
|
90
|
|
|
|
(105)
|
|
|
|
(144)
|
|
Loss (gain) on sale
of marketable debt securities
|
|
|
(527)
|
|
|
|
(9)
|
|
|
|
12
|
|
Interest income from
short-term deposits
|
|
|
(285)
|
|
|
|
(63)
|
|
|
|
-
|
|
Stock-based
compensation expense
|
|
|
2,066
|
|
|
|
2,231
|
|
|
|
1,783
|
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease in deferred
revenue from collaboration agreement
|
|
|
-
|
|
|
|
-
|
|
|
|
(538)
|
|
Decrease (increase)
in other accounts receivable
|
|
|
15
|
|
|
|
(609)
|
|
|
|
(63)
|
|
Increase (decrease)
in trade payables
|
|
|
1,047
|
|
|
|
4,185
|
|
|
|
(462)
|
|
Increase
(decrease) in other accounts payable
|
|
|
39
|
|
|
|
(141)
|
|
|
|
(142)
|
|
Net cash used in
operating activities
|
|
|
(26,287)
|
|
|
|
(14,937)
|
|
|
|
(9,023)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(44)
|
|
|
|
(12)
|
|
|
|
(90)
|
|
Investment in
securities, available for sale
|
|
|
(55,034)
|
|
|
|
(72,600)
|
|
|
|
(92,279)
|
|
Proceeds from sale of
securities, available for sale
|
|
|
47,198
|
|
|
|
101,098
|
|
|
|
38,421
|
|
Proceeds (investment)
in short-term deposits, net
|
|
|
24,416
|
|
|
|
(21,808)
|
|
|
|
(6,067)
|
|
Net cash provided
by (used in) investing activities
|
|
|
16,536
|
|
|
|
6,678
|
|
|
|
(60,015)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares and warrants, net of issuance costs (*)
|
|
|
707
|
|
|
|
-
|
|
|
|
79,149
|
|
Proceeds from
exercise of options
|
|
|
61
|
|
|
|
143
|
|
|
|
1,027
|
|
Net cash provided
by financing activities
|
|
|
768
|
|
|
|
143
|
|
|
|
80,176
|
|
Increase
(decrease) in cash and cash equivalents and restricted
cash
|
|
|
(8,983)
|
|
|
|
(8,116)
|
|
|
|
11,138
|
|
Cash and cash
equivalents and restricted cash at the beginning of the
year
|
|
|
16,043
|
|
|
|
24,159
|
|
|
|
13,021
|
|
Cash and cash
equivalents and restricted cash at the end of the
year
|
|
$
|
7,060
|
|
|
$
|
16,043
|
|
|
$
|
24,159
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
1,192
|
|
|
$
|
1,953
|
|
|
$
|
865
|
|
Cash paid for
taxes
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
75
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liabilities from adoption of ASU
2016-02
|
|
$
|
35
|
|
|
$
|
653
|
|
|
$
|
-
|
|
View original
content:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-provides-business-update-and-reports-fourth-quarter-and-year-end-2020-financial-results-301250097.html
SOURCE Galmed Pharmaceuticals Ltd.