TEL AVIV, Israel, Nov. 9,
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 nine months
ended September 30, 2017. 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™.
Business Update
- Galmed announced the publication of a paper entitled "Role of
Aramchol™ in steatohepatitis and fibrosis in mice"
in Hepatology Communications, a peer-reviewed, online
journal. This paper summarizes the work conducted by a
collaboration of key international basic and clinical scientists,
who are well known NASH experts. The data help to understand
the mechanism by which Aramchol exerts its effect on steatosis and
steato-fibrosis and identify its potential direct anti-fibrotic
effect. A poster of the data was presented at the American
Association for the Study of Liver Diseases (AASLD) Liver
Meeting on October 20-24, 2017 in
Washington, D.C.
- During the third quarter, the Company raised net proceeds of
approximately $2.7 million in a
registered direct offering to existing investors and a concurrent
private placement to Galmed's Chairman of the Board and an
additional board member. Both offerings were completed at
$7.10 per share.
- As of the beginning of November, 2017, all patients have been
randomized in the ARRIVE study. ARRIVE is a proof-of-concept
clinical trial that is evaluating the safety and efficacy of
Aramchol in 50 patients with HIV-associated lipodystrophy and
nonalcoholic fatty liver disease, or NAFLD. ARRIVE is a randomized,
double-blinded, placebo-controlled, proof-of-concept Phase IIa
clinical trial, comparing Aramchol at 600 mg versus placebo
over 12 weeks. It is an investigator-initiated study being
conducted by Professor Rohit Loomba at the NAFLD Research
Center, at the University of California San
Diego. The primary end point is improvement in hepatic
steatosis as measured by MRI. Secondary endpoints measure
improvements in total body fat, metabolic profile, and liver
biochemistry. Release of topline data is expected in the first
quarter of 2018.
"We are pleased with our continued progress on both our ARRIVE
and ARREST clinical trials, which we anticipate will report our
topline data in the first and second quarters of 2018,
respectively," said Allen Baharaff, President and Chief Executive
Officer of Galmed. Mr. Baharaff continued, "Moreover, we
strengthened our balance sheet with the support of institutional
investors, along with two members of our board."
Financial Summary - Third Quarter 2017 vs. Third Quarter
2016:
- Net loss of $2.8 million, or
$0.23 per share, for the three months
ended September 30, 2017, compared to
a net loss of $3.8 million, or
$0.34 per share, for the three months
ended September 30, 2016. This
period's net loss included $0.4
million of non-cash, stock-based compensation expense,
versus $0.2 million of non-cash
stock-based compensation expense incurred during the corresponding
period in 2016.
- The Company recognized $0.3
million of revenue for the three months ended September 30, 2017, compared to $0.2 million revenue for the three months ended
September 30, 2016. The revenue
relates to the amortization of the up-front payments under the
license agreement with Samil
Pharm.
- Research and development ("R&D") expenses amounted to
approximately $2.3 million for the
three months ended September 30,
2017, compared to approximately $3.3
million for the three months ended September 30, 2016. The decrease resulted
primarily from a decrease in expenses in connection with the ARREST
study.
- General and administrative expenses amounted to approximately
$0.70 million for the three months
ended September 30, 2017, compared to
approximately $0.66 million for the
three months ended September 30,
2016. The slight increase in general and administrative
expenses for the three months ended September 30, 2017 resulted primarily from an
increase in professional fees.
- Financial expenses amounted to $0.05
million for the three months ended September 30, 2017, compared to financial income
of $0.08 million for the three months
ended September 30, 2016. The
decrease in financial income for the three months ended
September 30, 2017 resulted primarily
from changes in the foreign currency exchange rate.
- Cash and cash equivalents and marketable securities totaled
$9.0 million as of September 30, 2017, compared to $15.5 million at December
31, 2016. Subsequent to the balance sheet date, the Company
raised net proceeds of approximately $1.1
million in its "at-the-market" equity offering program.
Galmed believes that its cash balance will be sufficient to
maintain its current operations through 2018.
Conference Call &
Webcast:
Thursday, November
9th @ 8:30am Eastern
Time
Toll-Free: 800-479-9001
Toll/International: 719-457-2639
Conference
ID:
9813581
Webcast: http://public.viavid.com/index.php?id=126942
Replays, available through November 23,
2017
Toll-Free: 844-512-2921
Toll/International: 412-317-6671
Replay
PIN: 9813581
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 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 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. 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 ongoing
Phase IIb ARREST Study, and planned Phase III trials for Aramchol™,
or whether Phase III trials will be conducted at all; completion
and receiving favorable results of these Phase IIb ARREST Study and
Phase III trials for Aramchol™; 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 in patients who are
overweight or obese and have pre diabetes or type II diabetes
mellitus; 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 23, 2017, 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,
2017
|
|
As of
December 31,
2016
|
|
Unaudited
|
|
Audited
|
Assets
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
Cash and cash
equivalents
|
$
|
2,614
|
|
$
|
3,097
|
Marketable
securities
|
|
6,344
|
|
|
12,351
|
Other accounts
receivable
|
|
171
|
|
|
284
|
Total current
assets
|
|
9,129
|
|
|
15,732
|
|
|
|
|
|
|
Property and
equipment, net
|
|
548
|
|
|
718
|
|
|
|
|
|
|
Total
assets
|
$
|
9,677
|
|
$
|
16,450
|
|
|
|
|
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
Trade
payables
|
$
|
1,965
|
|
$
|
3,122
|
Other accounts
payable
|
|
219
|
|
|
363
|
Short-term portion of
deferred revenue
|
|
811
|
|
|
1,094
|
Total current
liabilities
|
|
2,995
|
|
|
4,579
|
|
|
|
|
|
|
Long-term
liabilities
|
|
|
|
|
|
Related
parties
|
|
150
|
|
|
267
|
Long-term portion of
deferred revenue
|
|
-
|
|
|
529
|
Total long-term
liabilities
|
|
150
|
|
|
796
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
|
Ordinary shares par
value NIS 0.01 per share; Authorized 50,000,000;
Issued and outstanding: 12,733,512 shares as of September 30,
2017;
12,149,226 shares as of December 31, 2016
|
|
36
|
|
|
34
|
Additional paid-in
capital
|
|
79,479
|
|
|
75,446
|
Accumulated other
comprehensive loss
|
|
(8)
|
|
|
(85)
|
Accumulated
deficit
|
|
(72,975)
|
|
|
(64,320)
|
Total stockholders'
equity
|
|
6,532
|
|
|
11,075
|
|
|
|
|
|
|
Total liabilities
and stockholders' equity
|
$
|
9,677
|
|
$
|
16,450
|
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,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenue
|
$
|
273
|
|
$
|
193
|
|
$
|
811
|
|
$
|
193
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
2,331
|
|
|
3,342
|
|
|
7,421
|
|
|
10,086
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and
administrative expenses
|
|
697
|
|
|
656
|
|
|
2,110
|
|
|
2,236
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
2,755
|
|
|
3,805
|
|
|
8,720
|
|
|
12,129
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial expenses
(income), net
|
|
46
|
|
|
(78)
|
|
|
(65)
|
|
|
(108)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
2,801
|
|
|
3,727
|
|
|
8,655
|
|
|
12,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Taxes on
Income
|
|
-
|
|
|
105
|
|
|
-
|
|
|
106
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
$
|
2,801
|
|
$
|
3,832
|
|
$
|
8,655
|
|
$
|
12,127
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$
|
0.23
|
|
$
|
0.34
|
|
$
|
0.71
|
|
$
|
1.09
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average
number of shares outstanding
used in computing basic and diluted net loss per share
|
|
12,364,249
|
|
|
11,150,023
|
|
|
12,274,536
|
|
|
11,101,360
|
GALMED
PHARMACEUTICALS LTD.
|
|
Consolidated
Statements of Cash Flows (Unaudited)
|
U.S. Dollars in
thousands
|
|
|
|
|
Nine months
ended
September
30,
|
|
2017
|
|
2016
|
Cash flow from
operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
$
|
(8,655)
|
|
$
|
(12,127)
|
Adjustments
required to reconcile net loss to net cash used in operating
activities
|
|
|
|
|
|
|
Depreciation and
amortization
|
|
180
|
|
|
118
|
Stock-based
compensation expense
|
|
1,066
|
|
|
1,307
|
Amortization of
discount/premium on marketable securities
|
|
(187)
|
|
|
18
|
Loss from Realization
of marketable securities
|
|
130
|
|
|
150
|
Changes in
operating assets and liabilities:
|
|
|
|
|
|
|
Decrease in other
accounts receivable
|
|
113
|
|
|
13
|
Decrease in trade
payables
|
|
(1,157)
|
|
|
(556)
|
Decrease in other
accounts payable
|
|
(144)
|
|
|
(173)
|
Increase (decrease)
in related party
|
|
(117)
|
|
|
45
|
Increase (decrease)
in deferred revenue
|
|
(812)
|
|
|
1,897
|
Net cash used in
operating activities
|
|
(9,583)
|
|
|
(9,305)
|
|
|
|
|
|
|
|
Cash flow from
investing activities
|
|
|
|
|
|
|
Purchase of property
and equipment
|
|
(10)
|
|
|
(26)
|
Investment in
securities, available for sale
|
|
(1,447)
|
|
|
(2,480)
|
Maturity of
securities, available for sale
|
|
7,589
|
|
|
9,956
|
Net cash provided
in (used in) investing activities
|
|
6,132
|
|
|
7,450
|
|
|
|
|
|
|
|
Cash flow from
financing activities
|
|
|
|
|
|
|
Proceeds from
issuance of stock offerings, net of issuance costs
|
|
2,655
|
|
|
4,479
|
Proceeds from
exercise of options
|
|
313
|
|
|
255
|
Net cash used in
financing activities
|
|
2,968
|
|
|
4,734
|
|
|
|
|
|
|
|
Increase
(decrease) in cash and cash equivalents
|
|
(483)
|
|
|
2,879
|
Cash and cash
equivalents at the beginning of the year
|
|
3,097
|
|
|
4,156
|
Cash and cash
equivalents at the end of the period
|
$
|
2,614
|
|
$
|
7,035
|
|
|
|
|
|
|
|
Supplemental
disclosure of cash flow information:
|
|
|
|
|
|
|
Cash received from
interest
|
$
|
169
|
|
$
|
319
|
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SOURCE Galmed Pharmaceuticals Ltd.