TEL AVIV, Israel, March 23, 2017 /PRNewswire/ -- Galmed
Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a
clinical-stage biopharmaceutical company focused on the development
of a once-daily, oral therapy for the treatment of nonalcoholic
steatohepatitis, or NASH, and other liver diseases, today reported
financial results for the three and twelve months
ended December 31, 2016, and announced new and exciting data
from recently completed pre-clinical studies demonstrating
Aramchol™'s potential direct effect on liver fibrosis.
The data will be presented at the International Liver Congress™
2017, to be held from April 19 to the
23rd in Amsterdam, the
Netherlands.
The Company will host a conference call and webcast today to
discuss the financial results and to provide an update on current
developments with respect to its clinical programs for
Aramchol™.
"Aramchol™'s anti-steatosis effect was previously
established and translated to humans in our phase IIa study.
Pre-clinical studies demonstrate Aramchol™ is
targeting fibrosis via two main pathways – (1) by down regulating
steatosis which is the main cause of inflammation and fibrosis; and
(2) by directly down regulating collagen production. The new data
suggests the potential direct effect of Aramchol™ in
the treatment of liver fibrosis," said Mr. Allen Baharaff, Galmed's President and CEO.
"The TAA model is the best known animal model for experimental
induced liver fibrosis and cirrhosis. In this model, we
investigated the effect of Aramchol™ on liver
fibrosis. We found that Aramchol™ significantly
reduced the amount of fibrosis in comparison to a control group
which received placebo. The results are significant and quite
impressive," said Prof. Shimon Reif,
Gastroenterologist and Head of Pediatric Department at Hadassah
Medical Center at the Hebrew University of
Jerusalem. Prof. Reif continued, "The effect seen in the TAA
model is due to direct effect on collagen production from stellate
cells."
"As we previously reported on January 9,
2017, we have completed the enrolment of the ARREST Study,
and 248 patients have been randomized. Top line Data is expected to
be available during the second quarter of 2018. We believe that our
cash balance will be sufficient to maintain our current operations
through the first half of 2018, and allow the completion of the
ARREST study as scheduled," said Mr. Baharaff.
Financial Summary – Full Year 2016 vs. Full Year 2015; 4Q16
vs. 4Q15:
- Cash and cash equivalents and marketable securities totaled
approximately $15.5 million as of
December 31, 2016, compared with
approximately $23.0 million as of
December 31, 2015. This decrease
primarily resulted from approximately $12.1
million used in operating activities, mainly due to our
ongoing clinical studies and operational activities, which was
partially offset by net proceeds of approximately $4.5 million raised through our ATM
offering.
- The Company recorded a net loss of approximately $17.0 million, or approximately $1.49 per share, for the twelve months ended
December 31, 2016, compared with a
net loss of approximately $10.6
million, or approximately $0.96 per share, for the twelve months ended
December 31, 2015. During 2016, total
R&D expenses increased by approximately $6.7 million, or approximately 88%, to
approximately $14.3 million, and
total G&A expenses decreased by approximately $168 thousand, or approximately 5%, to
approximately $3.1 million. In
addition, 2016's net loss included approximately $1.6 million of non-cash, stock-based
compensation expense versus approximately $970 thousand of non-cash stock-based
compensation expense incurred during the corresponding period in
2015.
- For the quarter ended December 31,
2016, the net loss was approximately $4.8 million, or approximately $0.40 per share, which compares with
approximately $3.2 million, or
approximately $0.29 per share, for
the same period in 2015. During the fourth quarter of 2016, total
R&D expenses increased approximately $1.4 million to approximately $4.2 million, and total G&A expenses
increased approximately $273 thousand
to approximately $842 thousand. This
quarter's net loss included approximately $160 thousand of non-cash, stock-based
compensation income versus approximately $321 thousand of non-cash stock-based
compensation expense incurred during the corresponding period in
2015.
- The Company recognized approximately $0.5 million of revenue for the twelve months
ended December 31, 2016, compared to
no revenue for the same period in 2015. The revenue relates to the
amortization of the up-front payments under the Company's license
agreement with Samil Pharm Co. Ltd. The remaining unamortized
up-front payment of approximately $1.6
million is reflected on the balance sheet as short-term and
long-term portion of deferred revenue and will be amortized through
the contractual term of the agreement.
- Research and development expenses were approximately
$14.3 million for the twelve months
ended December 31, 2016, compared
with approximately $7.6 million for
the twelve months ended December 31,
2015. The increase primarily resulted from an increase in
expenses related to the ARREST Study as the trial continues to
progress. The increase is also a result of an increase in 2016 of
non-cash stock-based compensation expense. For the quarter ended
December 31, 2016, research and
development expenses totaled approximately $4.2 million, which compares with approximately
$2.8 million for the same period in
2015. The increase primarily resulted from an increase in expenses
related to the ARREST Study and also as a result of an increase in
non-cash stock-based compensation expense.
- The Company incurred general and administrative expenses of
approximately $3.1 million for the
twelve months ended December 31,
2016, compared with approximately $3.2 million for the twelve months ended
December 31, 2015. The decrease
primarily resulted from a decrease in investor relations
expenses.
- For the quarter ended December 31,
2016, general and administrative expenses totaled
approximately $842 thousand, which
compares with approximately $569
thousand for the same period in 2015. The increase primarily
resulted from an increase in stock-based compensation expense.
Conference Call & Webcast:
Thursday, March
23, 2017, 8:30 am Eastern Time / 5:30 am Pacific
Time
|
Participant Dial-In
Numbers:
|
|
Toll-Free:
|
+1-888-663-2242
|
Toll/International:
|
+1-913-312-0380
|
Conference
ID:
|
3745268
|
Webcast:
|
http://galmedpharma.investorroom.com/events
|
|
Replay,
available until April 6, 2017
|
Replay Dial-In
Numbers:
|
|
Toll-Free:
|
+1-844-512-2921
|
Toll/International:
|
+1-412-317-6671
|
Passcode:
|
3745268
|
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 down regulation of the three key pathologies
of NASH; steatosis, inflammation and fibrosis. The effect of
Aramchol™ on fibrosis is mediated by down
regulation of steatosis and directly on human collagen producing
cells. Aramchol™ has been granted by the
FDA Fast Track designation status for the treatment of
NASH.
NASH is an emerging world crisis impacting 3% to 5% of the U.S.
population and 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 is a
clinical-stage biopharmaceutical company focused on the development
of Aramchol™, a first in class, novel,
once-daily, oral therapy for the treatment of NASH for variable
populations, as well as other liver associated disorders. Galmed is
currently conducting the ARREST Study, a multicenter, randomized,
double blind, placebo-controlled Phase IIb clinical study designed
to evaluate the efficacy and safety of
Aramchol™ in subjects with NASH, who are
overweight or obese, and who are pre-diabetic or type-II-diabetic.
Galmed also sponsors the ARRIVE Study, a proof-of-concept Phase IIa
clinical trial designed to evaluate the safety and efficacy of
Aramchol in up to 50 patients with HIV-associated NAFLD and
lipodystrophy. The ARRIVE Study is an investigator-initiated trial,
conducted at the University of California San
Diego by Professor Rohit
Loomba. More information about the ARREST Study and the
ARRIVE Study may be found on ClinicalTrials.gov identifiers:
NCT02279524 and NCT02684591, respectively.
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. Applicable
risks and uncertainties include risks and uncertainties associated
with the initiation, timing, progress and results of the Company's
research, preclinical studies and clinical trials as well as risks
and uncertainties identified under the heading "Risk Factors"
included in Galmed's most recent Annual Report on Form 20-F filed
with the Securities and Exchange Commission, or the SEC 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 December
31,
|
|
|
2016
|
2015
|
Assets
|
|
|
|
Current
assets
|
|
|
|
Cash and cash
equivalents
|
|
$
3,097
|
$
4,156
|
Marketable
securities
|
|
12,351
|
18,845
|
Other accounts
receivable
|
|
284
|
379
|
Total current
assets
|
|
15,732
|
23,380
|
|
|
|
|
Property and
equipment, net
|
|
718
|
883
|
|
|
|
|
Total
assets
|
|
$
16,450
|
$
24,263
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
Trade
payables
|
|
3,122
|
2,259
|
|
Other accounts
payable
|
|
363
|
282
|
|
Short-term portion of
deferred revenue
|
|
1,094
|
-
|
|
Total current
liabilities
|
|
4,579
|
2,541
|
|
|
|
|
|
|
Long-term
liabilities
|
|
|
|
|
Related
parties
|
|
267
|
177
|
|
Long-term portion of
deferred revenue
|
|
529
|
-
|
|
Total long-term
liabilities
|
|
796
|
177
|
|
|
|
|
|
|
Stockholders'
equity
|
|
|
|
|
Ordinary shares, par
value NIS 0.01 per share;
Authorized 50,000,000
shares;
Issued and
outstanding: 12,149,226 shares as of December 31, 2016; 11,100,453
shares as of December 31, 2015
|
|
34
|
32
|
|
Additional paid-in
capital
|
|
75,446
|
69,086
|
|
Accumulated other
comprehensive loss
|
|
(85)
|
(206)
|
|
Accumulated
deficit
|
|
(64,320)
|
(47,367)
|
|
Total stockholders'
equity
|
|
11,075
|
21,545
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
|
$
16,450
|
$
24,263
|
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Operations (Audited)
|
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
|
|
|
Three months
ended
December
31,
|
|
|
Twelve months
ended
December
31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2016
|
|
|
2015
|
|
Revenue
|
|
$
|
274
|
|
|
$
|
-
|
|
|
$
|
467
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
4,185
|
|
|
|
2,776
|
|
|
|
14,271
|
|
|
|
7,629
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
|
842
|
|
|
|
569
|
|
|
|
3,078
|
|
|
|
3,246
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
4,753
|
|
|
|
3,345
|
|
|
|
16,882
|
|
|
|
10,875
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income), net
|
|
|
73
|
|
|
|
(140)
|
|
|
|
(35)
|
|
|
|
(253)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
4,826
|
|
|
|
3,205
|
|
|
|
16,847
|
|
|
|
10,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
|
-
|
|
|
|
-
|
|
|
|
106
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
$
|
4,826
|
|
|
$
|
3,205
|
|
|
$
|
16,953
|
|
|
$
|
10,622
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
$
|
0.40
|
|
|
$
|
0.29
|
|
|
$
|
1.49
|
|
|
$
|
0.96
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding used in computing basic and diluted
net loss per share
|
|
|
12,149,226
|
|
|
|
11,100,453
|
|
|
|
11,374,653
|
|
|
|
11,100,453
|
|
GALMED
PHARMACEUTICALS LTD.
|
Consolidated
Statements of Cash Flows (audited)
|
U.S. Dollars in
thousands, except share data and per share data
|
|
|
Year ended
December 31,
|
|
2016
|
2015
|
Cash flow from
operating activities
|
|
|
|
|
|
Net loss for the
year
|
$
(16,953)
|
$
(10,622)
|
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation and
amortization
|
169
|
50
|
Amortization of
discount/premium on marketable securities
|
44
|
92
|
Loss from realization
of marketable securities
|
231
|
50
|
Stock-based
compensation expense
|
1,628
|
970
|
Changes in
operating assets and liabilities:
|
|
|
Increase in deferred
revenue from collaboration agreement
|
1,623
|
–
|
Decrease (increase)
in other accounts receivable
|
95
|
(214)
|
Increase (decrease)
in trade payables
|
863
|
1,384
|
Increase (decrease)
in other accounts payable
|
81
|
39
|
Increase (decrease)
in related party
|
90
|
(223)
|
Net cash used in operating activities
|
(12,129)
|
(8,474)
|
|
|
|
Cash flow from
investing activities
|
|
|
Purchase of property
and equipment
|
(17)
|
(159)
|
Proceeds from sale of
property and equipment
|
13
|
–
|
Investment in
securities, available for sale
|
(7,615)
|
(26,541)
|
Proceeds from sale of
securities, available for sale
|
13,955
|
9,594
|
Disposal of
(Investment in) short-term deposit
|
–
|
6,000
|
Net cash provided by (used in) investing activities
|
6,336
|
(11,106)
|
|
|
|
Cash flow from
financing activities
|
|
|
Issuance of stock
offerings, net of issuance costs (**)
|
4,479
|
–
|
Proceeds from
exercise of options
|
255
|
–
|
Net cash provided by financing activities
|
4,734
|
–
|
Increase
(decrease) in cash and cash equivalents
|
(1,059)
|
(19,580)
|
Cash and cash
equivalents at the beginning of the year
|
4,156
|
23,736
|
Cash and cash
equivalents at the end of the year
|
$
3,097
|
$
4,156
|
|
|
|
Cash received from
interest
|
$
382
|
$
473
|
Cash paid for
taxes
|
$
106
|
$
-
|
GALMED
PHARMACEUTICALS LTD.
|
|
Notes to
Consolidated Statements of Operations (audited)
|
|
U.S. Dollars in
thousands
|
|
|
|
Research and
Development Expenses:
|
|
|
|
|
|
|
|
|
|
Three months
ended
December 31,
|
|
Year ended
December 31,
|
|
|
2016
|
2015
|
|
2016
|
2015
|
|
|
(in
thousands)
|
|
(in
thousands)
|
|
Chemistry and
formulation studies
|
$
267
|
$
818
|
|
$
1,802
|
$
1,902
|
|
Salaries and
benefits
|
405
|
251
|
|
1,004
|
808
|
|
Stock-based
compensation
|
24
|
(105)
|
|
757
|
111
|
|
Research and
preclinical studies
|
288
|
233
|
|
924
|
637
|
|
Clinical
studies
|
3,103
|
1,412
|
|
9,263
|
3,671
|
|
Regulatory and other
expenses
|
98
|
167
|
|
521
|
500
|
|
|
$
4,185
|
$
2,776
|
|
$
14,271
|
$
7,629
|
|
|
|
|
|
General and
Administrative Expenses:
|
|
|
|
|
|
|
|
|
|
Three months
ended
December 31,
|
|
Year ended
December 31,
|
|
|
2016
|
2015
|
|
2016
|
2015
|
|
|
(in
thousands)
|
|
(in
thousands)
|
|
Stock-based
compensation
|
$
297
|
$
(55)
|
|
$
871
|
$
858
|
|
Professional
fees
|
144
|
130
|
|
683
|
741
|
|
Salaries and
benefits
|
262
|
262
|
|
849
|
747
|
|
Traveling and
conference costs
|
14
|
17
|
|
106
|
65
|
|
Rent and
office-maintenance fees
|
55
|
129
|
|
303
|
359
|
|
Investor relations and
business development
|
66
|
78
|
|
248
|
457
|
|
Other
|
4
|
8
|
|
18
|
19
|
|
|
$
842
|
$
569
|
|
$
3,078
|
$
3,246
|
|
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/galmed-pharmaceuticals-reports-fourth-quarter-and-full-year-2016-financial-results-300427654.html
SOURCE Galmed Pharmaceuticals Ltd.