- Conference Call and Webcast Today at 8:30 a.m. ET / 5:30 a.m.
PT -
TEL AVIV, Israel, May 2, 2022 /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 twelve months ended December 31,
2021.
Recent Clinical & Scientific Developments
- Announced positive interim results from Open-Label part of the
ARMOR study showing that treatment with Aramchol 300mg BID resulted
in a high rate of fibrosis improvement using three separate biopsy
reading methodologies (NASH CRN, Ranked paired reading and a
Quantitative Digital Pathology image analysis and artificial
intelligence (AI) method), with a larger treatment effect with
longer duration of therapy.
- Results of post baseline biopsies performed either at 24 weeks
or at 48 weeks from 46 subjects with NASH and F1-3 that received
Aramchol showed greater histological improvement at week 48 in both
paired and AI evaluations (65% and 100% respectively) compared to
NASH CRN scoring (40%).
Financial Summary – Full Year 2021 vs. Full Year 2020; 4Q21
vs. 4Q20:
For the three and twelve months ended
December 31, 2021, the Company
recorded a net loss of $7.5 million
and $32.5 million or $0.30 and $1.32 per
share, respectively, compared with a net loss of $10.3 million and $28.8
million, or $0.48 and
$1.35 per share, for the three and
twelve months ended December 31,
2020.
Research and development expenses were
$27.2 million for the twelve months
ended December 31, 2021, compared
with $26.1 million for the twelve
months ended December 31, 2020. The
increase for the twelve months resulted primarily from an increase
in clinical trial expenses in connection with the Company's ongoing
ARMOR study, partially offset by a decrease in expenses related to
CMC and formulation expenses.
For the three months ended December 31,
2021, research and development expenses totaled $6.3 million, which compares with $9.0 million for the same period in 2020. The
decrease for the three months resulted primarily from a decrease in
clinical trial expenses and a decrease in expenses related to CMC
and formulation expenses.
The Company incurred general and administrative
expenses of $5.7 million for the
twelve months ended December 31,
2021, compared with $4.1
million for the twelve months ended December 31, 2020. The increase for the twelve
months primarily resulted from an increase in salaries and benefits
expenses, and as well from an increase in the cost of the Company's
D&O insurance policy premium.
For the three months ended December 31,
2021, general and administrative expenses totalled
$1.2 million, which compares with
$1.3 million for the same period in
2020.
Financial income, net amounted to $0.4 million for the twelve months ended
December 31, 2021, compared with
$1.4 million for the twelve months
ended December 31, 2020. For the
three months ended December 31, 2021,
financial income, net totalled $0.04
million, which compares with $0.07
million for the same period in 2020.
- Cash and cash equivalents, restricted cash, short-term
deposits, and marketable debt securities totaled $34.9 million as of December 31, 2021, compared with $51.0 million as of December 31, 2020.
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:
May 2, 2022, 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: 13727793
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1535647&tp_key=893b75d833
Replay Dial-In Numbers
Toll Free:
1-844-512-2921
Toll/International: 1-412-317-6671
Replay Pin Number: 13727793
Replay Start: Monday May 2, 2022,
11:30 AM ET
Replay Expiry: Monday May 16, 2022,
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.
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
May 2, 2022, 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,
|
|
|
|
|
|
|
2021
|
|
|
2020
|
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
|
|
$
|
2,884
|
|
|
$
|
6,947
|
|
Restricted
cash
|
|
|
|
|
|
114
|
|
|
|
113
|
|
Short-term
deposits
|
|
|
|
|
|
-
|
|
|
|
3,807
|
|
Marketable debt
securities
|
|
|
|
|
|
31,931
|
|
|
|
40,132
|
|
Other accounts
receivable
|
|
|
|
|
|
1,125
|
|
|
|
812
|
|
Total current
assets
|
|
|
|
|
|
36,054
|
|
|
|
51,811
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
right-of-use assets
|
|
|
|
|
|
406
|
|
|
|
394
|
|
Property and equipment,
net
|
|
|
|
|
|
145
|
|
|
|
176
|
|
Total non-current
assets
|
|
|
|
|
|
551
|
|
|
|
570
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
|
|
|
$
|
36,605
|
|
|
$
|
52,381
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
Trade
payables
|
|
|
|
|
$
|
4,871
|
|
|
$
|
7,046
|
|
Other accounts
payable
|
|
|
|
|
|
1,008
|
|
|
|
966
|
|
Total current
liabilities
|
|
|
|
|
|
5,879
|
|
|
|
8,012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
Operating lease
liabilities, net of current portion
|
|
|
|
|
$
|
229
|
|
|
$
|
216
|
|
Total non-current
liabilities
|
|
|
|
|
|
229
|
|
|
|
216
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share; Authorized 50,000,000 shares;
Issued and outstanding: 25,088,414 shares as of December 31, 2021;
21,325,975
shares as of December 31, 2020
|
|
|
|
|
|
70
|
|
|
|
58
|
|
Additional paid-in
capital
|
|
|
|
|
|
198,772
|
|
|
|
179,530
|
|
Accumulated other
comprehensive income (loss)
|
|
|
|
|
|
(171)
|
|
|
|
272
|
|
Accumulated
deficit
|
|
|
|
|
|
(168,174)
|
|
|
|
(135,707)
|
|
Total stockholders'
equity
|
|
|
|
|
|
30,497
|
|
|
|
44,153
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
|
|
|
$
|
36,605
|
|
|
$
|
52,381
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Operations (Audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
Year ended December
31,
|
|
|
2021
|
|
|
2020
|
|
|
2019
|
Research and
development expenses
|
|
|
27,220
|
|
|
|
26,082
|
|
|
|
18,180
|
General and
administrative expenses
|
|
|
5,661
|
|
|
|
4,128
|
|
|
|
4,196
|
Total operating
loss
|
|
|
32,881
|
|
|
|
30,210
|
|
|
|
22,376
|
Financial income,
net
|
|
|
(414)
|
|
|
|
(1,439)
|
|
|
|
(1,915)
|
Net
loss
|
|
$
|
32,467
|
|
|
$
|
28,771
|
|
|
$
|
20,461
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
1.32
|
|
|
$
|
1.35
|
|
|
$
|
0.97
|
Weighted-average number
of shares outstanding used in
computing basic and diluted net loss per share
|
|
|
24,597,638
|
|
|
|
21,280,787
|
|
|
|
21,114,399
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (Audited)
|
U.S. Dollars in
thousands
|
|
|
|
Year ended December
31,
|
|
|
2021
|
|
|
2020
|
|
|
2019
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for the
year
|
|
$
|
(32,467)
|
|
|
$
|
(28,771)
|
|
|
$
|
(20,461)
|
Adjustments required
to reconcile net loss to net cash used in
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
|
42
|
|
|
|
39
|
|
|
|
35
|
Amortization of
discount (premium) on marketable debt securities
|
|
|
121
|
|
|
|
90
|
|
|
|
(105)
|
Gain on sale of
marketable debt securities
|
|
|
(37)
|
|
|
|
(527)
|
|
|
|
(9)
|
Finance
expenses
|
|
|
6
|
|
|
|
31
|
|
|
|
3
|
Interest income from
short-term deposits
|
|
|
7
|
|
|
|
(285)
|
|
|
|
(63)
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based
compensation expense
|
|
|
1,886
|
|
|
|
2,066
|
|
|
|
2,231
|
Changes in operating
assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in
other accounts receivable
|
|
|
(313)
|
|
|
|
15
|
|
|
|
(609)
|
Increase (decrease) in
trade payables
|
|
|
(2,175)
|
|
|
|
1,047
|
|
|
|
4,185
|
Increase (decrease) in
other accounts payable
|
|
|
38
|
|
|
|
8
|
|
|
|
(144)
|
Net cash used in
operating activities
|
|
|
(32,892)
|
|
|
|
(26,287)
|
|
|
|
(14,937)
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
|
(11)
|
|
|
|
(44)
|
|
|
|
(12)
|
Increase in restricted
deposit
|
|
|
(1)
|
|
|
|
-
|
|
|
|
-
|
Investment in
securities, available for sale
|
|
|
(13,569)
|
|
|
|
(55,034)
|
|
|
|
(72,600)
|
Proceeds from sale of
securities, available for sale
|
|
|
21,243
|
|
|
|
47,198
|
|
|
|
101,098
|
Proceeds from
(investment in) short-term deposits, net
|
|
|
3,800
|
|
|
|
24,416
|
|
|
|
(21,808)
|
Net cash provided by
investing activities
|
|
|
11,462
|
|
|
|
16,536
|
|
|
|
6,678
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of ordinary
shares in at-the-market offering, net of
issuance costs
|
|
|
8,147
|
|
|
|
-
|
|
|
|
-
|
Issuance of ordinary
shares, net of issuance costs (**)
|
|
|
9,221
|
|
|
|
707
|
|
|
|
-
|
Proceeds from exercise
of options
|
|
|
(*)
|
|
|
|
61
|
|
|
|
143
|
Net cash provided by
financing activities
|
|
|
17,368
|
|
|
|
768
|
|
|
|
143
|
Decrease in cash,
cash equivalents and restricted cash
|
|
|
(4,062)
|
|
|
|
(8,983)
|
|
|
|
(8,116)
|
Cash and cash
equivalents and restricted cash at the
beginning of the year
|
|
|
7,060
|
|
|
|
16,043
|
|
|
|
24,159
|
Cash, cash
equivalents and restricted cash at the end of the
year
|
|
$
|
2,998
|
|
|
$
|
7,060
|
|
|
$
|
16,043
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
|
|
|
|
|
Cash received from
interest
|
|
$
|
562
|
|
|
$
|
1,192
|
|
|
$
|
1,953
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash
transactions:
|
|
|
|
|
|
|
|
|
|
|
|
Recognition of
right-of-use asset and lease liabilities from
adoption of ASU 2016-02, net
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
653
|
|
|
|
|
|
|
|
|
|
|
|
|
Right-of-use assets
obtained in exchange for new operating lease liabilities,
net
|
|
$
|
199
|
|
|
$
|
35
|
|
|
$
|
-
|
|
|
|
(*) Represents amount
less than $1
|
View original
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SOURCE Galmed Pharmaceuticals Ltd.