JERUSALEM, Aug. 9, 2019 /PRNewswire/ -- Intec Pharma
Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") today announces
financial results for the three and six months ended June 30, 2019.
Highlights of the second quarter 2019 and recent weeks
include:
- Completed the qualification studies for the commercial scale
manufacture of Accordion Pill®-Carbidopa/Levodopa
(AP-CD/LD) with LTS LohmanTherapie-Systeme;
- Announced topline results from the Company's pivotal Phase 3
trial (the ACCORDANCE trial) evaluating the safety and efficacy of
the AP-CD/LD compared with immediate release CD/LD (IR-CD/LD;
Sinemet®) as a treatment for the symptoms of advanced
Parkinson's disease (PD), reporting that AP-CD/LD provided
treatment for Parkinson's disease symptoms but did not demonstrate
statistically superiority to IR-CD/LD in terms of reduction in OFF
time from baseline under the conditions established in the
protocol;
- Completed the pharmacokinetic (PK) study of the custom-designed
AP developed for a proprietary compound under the previously
announced feasibility and option agreement with Novartis
Pharmaceuticals;
- Entered into an agreement with Merck to explore using the AP
platform for an undisclosed development program;
- Published a review highlighting the benefits of the AP oral
drug delivery platform in the peer-reviewed journal, Therapeutic
Delivery;
- Published the results from an earlier Phase 2 clinical study of
the AP-CD/LD in PD patients in the peer-reviewed journal,
Parkinsonism and Related Disorders;
- Presented data from the PK study of AP-CD/LD 50/500 mg TID in a
poster at the XXIV World Congress on Parkinson's Disease and
Related Disorders; and
- Granted European patent titled, "Delivery Device for Oral
Intake of an Agent," which covers Intec's gastro-retentive drug
delivery device with perforated external film.
Management Commentary
"We were very disappointed that the ACCORDANCE study did not
meet its target endpoints. In our preliminary review of the
top-line data, we noted sub-sets of patients that performed
particularly well, showing meaningful reduction in OFF time
compared with IR-CD/LD. Based on our preliminary review, we believe
we may not have been able to administer enough LD to certain
patients as it was agreed with the U.S. Food and Drug
Administration (FDA) that the maximum dose would be three APs per
day. Given the long-term safety profile established by this trial,
we believe this limitation should be removed and that this could
present a method of providing additional LD to those patients who
need it. We believe the on-going analyses of this study will
lead to an improved understanding of what will be required in
future studies to generate approvable clinical data with the AP
delivery platform in PD," stated Jeffrey A.
Meckler, Vice Chairman and Chief Executive Officer of Intec
Pharma.
"During the second quarter, we made significant progress
advancing and expanding our partner-sponsored programs. We
are excited to have successfully completed the PK study for our
custom-designed AP for Novartis' proprietary compound and are
looking forward to advancing this program into potential
partnership discussions. This partnership holds significant
promise as the market opportunity for this proprietary compound is
in excess of $1 billion. In addition,
we entered into a research collaboration with Merck for the
development of a custom-designed AP for one of Merck's proprietary
compounds and are now initiating the design and construction of
this new AP for this very promising program.
"We continue to make progress refining the AP for our cannabis
program and hope to advance our proprietary AP containing synthetic
tetrahydrocannabinol (AP-THC), one of the primary cannabinoids
contained in cannabis, into a new PK study next year. The Accordion
Pill has the potential to address several major drawbacks of
current methods of use and treatment with cannabis and
cannabinoids, such as short duration of effect, delayed onset,
variability of exposure, variable potency batch to batch,
variability of the administered dose and adverse events that
correlate with rate of rise and peak levels. Given the known
analgesic properties of cannabinoids, we remain
enthusiastic about the potential for these programs and
believe our AP-cannabinoids will be applicable to a variety of pain
indications.
"While the ACCORDANCE results were not what we expected, we
continue to believe in the potential of the AP platform. Toward
that end, we plan to seek to move forward with a commercial
agreement with Novartis. In addition, once we obtain the final data
from our ACCORDANCE study, we plan to look for ways to advance this
program forward, whether on our own or through a potential
partnership. In tandem, we plan to continue to build our AP drug
delivery platform with the addition of both partner-sponsored
R&D programs, such as Novartis and Merck, and through
internally led drug reformulation programs, such as our cannabis
program in pain indications. We believe this strategy provides the
best opportunities for both short- and long-term growth," concluded
Mr. Meckler.
Financial Highlights for the Three and Six Months Ended
June 30, 2019
Research and development expenses, net, for the three-month
period ended June 30, 2019 were
approximately $7.9 million, a
decrease of approximately $500,000,
or 6%, compared with approximately $8.4
million for the second quarter of 2018. Research and
development expenses, net, for the six-month period ended June
30, 2019 amounted to approximately $16.4 million, a
decrease of approximately $900,000, or 5%, compared with
approximately $17.3 million in the six-month period
ended June 30, 2018. The decrease in both periods was
primarily due to a decrease in expenses related to our ACCORDANCE
study and open label extension study, offset by an increase in
expenses related to the scale up activities for the
commercial-scale production capabilities for AP-CD/LD at LTS.
General and administrative expenses for the three-month period
ended June 30, 2019 were
approximately $2.1 million, a
decrease of approximately $100,000 or 5%, compared
with approximately $2.2 million in
the three-month period ended June 30,
2018. General and administrative expenses for the
six-month period ended June 30, 2019 amounted to
approximately $4.3 million, an increase of
approximately $200,000, or 5%, compared with
approximately $4.1 million in the six-month period
ended June 30, 2018. The increase in the six-month period
was primarily related to the increase in payroll and related
expenses mainly due to an increase in headcount and salary raises
and insurance expenses, offset by a decrease in professional
services.
Net loss for the three-month period ended June 30, 2019 was approximately $10.0 million, compared with a net loss of
$11.0 million in the prior year's
second quarter. Net loss for the six-month period ended
June 30, 2019 was $20.7 million compared with $21.8 million during the six-month period ended
June 30, 2018.
Loss per ordinary share for the three-month period ended
June 30, 2019 was $0.30 compared with a loss per ordinary share of
$0.34 for the three-month period
ended June 30, 2018. Loss per
ordinary share for the six-month period ended June 30, 2019 was $0.62 compared with a loss per ordinary share of
$0.75 for the six-month period ended
June 30, 2018.
As of June 30, 2019, the Company
had cash and cash equivalents and marketable securities of
approximately $21.6 million compared
with approximately $40.6 million at
December 31, 2018.
Net cash used in operating activities during the six-month
period ended June 30, 2019 was
approximately $17.7 million compared
with net cash used in operating activities of approximately
$19.9 million during the
six-month period ended June 30, 2018.
This decrease resulted primarily from the decrease in the net loss
for the period in the amount of $1.1
million and from changes in operating assets and liabilities
items of approximately $300,000.
The Company had negative cash flow from investing activities of
approximately $1.0 million during the
six-month period ended June 30, 2019
compared to negative cash flow from investing activities of
approximately $4.3 million during the
six-month period ended June 30, 2018.
This decrease resulted primarily from a decrease in purchase of
property and equipment in the amount of approximately $2.5 million, an increase in proceeds from the
disposal of marketable securities in the amount of approximately
$576,000 and a decrease of
approximately $261,000 in investment
in other assets related to the establishment of the commercial
scale production capabilities for AP-CD/LD at LTS.
Net cash provided by financing activities during the six-month
period ended June 30, 2019 was
approximately $268,000, which was
provided by the proceeds from the exercise of options by employees.
Net cash provided by financing activities for the six months ended
June 30, 2018 was approximately
$35.0 million which was mainly
provided by funds received from our April
2018 public offering of ordinary shares.
About Intec Pharma Ltd.
Intec Pharma is a clinical-stage biopharmaceutical company
focused on developing drugs based on its proprietary Accordion Pill
platform technology. The Company's Accordion Pill is an oral drug
delivery system that is designed to improve the efficacy and safety
of existing drugs and drugs in development by utilizing an
efficient gastric retention and specific release mechanism. The
Company's product pipeline includes two product candidates in
clinical trial stages: Accordion Pill Carbidopa/Levodopa, or
AP-CD/LD, which is in late-stage Phase 3 development for the
treatment of Parkinson's disease symptoms in advanced Parkinson's
disease patients, and AP-cannabinoids, an Accordion Pill to deliver
either or both of the primary cannabinoids contained in Cannabis
sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for
various pain indications. In addition, the Company has a
feasibility agreement for the development of a custom-designed
Accordion Pill for a proprietary compound with Novartis
Pharmaceuticals and a research collaboration with Merck &
Co.
For more information, visit www.intecpharma.com. Intec Pharma
routinely posts information that may be important to investors in
the Investor Relations section of its website.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward looking statements about our
expectations, beliefs and intentions. Forward-looking statements
can be identified by the use of forward-looking words such as
"believe", "expect", "intend", "plan", "may", "should", "could",
"might", "seek", "target", "will", "project", "forecast",
"continue" or "anticipate" or their negatives or variations of
these words or other comparable words or by the fact that these
statements do not relate strictly to historical matters. These
forward-looking statements 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 in this press release are made as of the date of this
press release, and we undertake no duty to update or revise any
such statements, whether as a result of new information, future
events or otherwise. Forward-looking statements are not guarantees
of future performance and are subject to risks and uncertainties,
many of which are outside of our control. Many factors could cause
our actual activities or results to differ materially from the
activities and results anticipated in forward-looking statements,
including, but not limited to, the following: our limited operating
history and history of operating losses, our ability to continue as
a going concern, our ability to obtain additional financing, our
ability to successfully operate our business or execute our
business plan, the timing and cost of our clinical trials, the
completion and receiving favorable results in our clinical trials,
our ability to obtain and maintain regulatory approval of our
product candidates, our ability to protect and maintain our
intellectual property and licensing arrangements, our ability to
develop, manufacture and commercialize our product candidates, the
risk of product liability claims, the availability of
reimbursement, and the influence of extensive and costly government
regulation. More detailed information about the risks and
uncertainties affecting us is contained under the heading "Risk
Factors" included in our most recent Annual Report on Form 10-K
filed with the SEC on February 27, 2019, and in
other filings that we have made and may make with
the Securities and Exchange Commission in the
future.
-Tables to Follow -
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Unaudited)
|
|
|
|
|
June
30,
|
December
31,
|
|
2019
|
2018
|
|
U.S.
dollars
|
|
in
thousands
|
|
|
|
Assets
|
|
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
$
20,796
|
$
39,246
|
Investment in
marketable securities
|
762
|
1,333
|
Prepaid expenses and
other receivables
|
3,072
|
2,986
|
TOTAL CURRENT
ASSETS
|
24,630
|
43,565
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
Other
assets
|
7,487
|
5,431
|
Property and
equipment, net
|
12,455
|
12,233
|
Operating lease
right-of-use assets
|
1,859
|
-
|
Deferred tax
assets
|
429
|
281
|
TOTAL NON-CURRENT
ASSETS
|
22,230
|
17,945
|
|
|
|
TOTAL
ASSETS
|
$
46,860
|
$
61,510
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
CURRENT
LIABILITIES -
|
|
|
Accounts payable and
accruals:
|
|
|
Trade
|
$
2,331
|
$
2,849
|
Other
|
7,679
|
4,807
|
TOTAL CURRENT
LIABILITIES
|
10,010
|
7,656
|
LONG-TERM
LIABILITIES -
|
|
|
Non-current operating lease liabilities
|
1,269
|
-
|
Other liabilities
|
472
|
309
|
TOTAL LONG-TERM
LIABILITIES
|
1,741
|
309
|
TOTAL
LIABILITIES
|
11,751
|
7,965
|
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
Ordinary
shares, with no par value - authorized: 100,000,000
Ordinary Shares as of June 30, 2019 and December
31, 2018; issued
and outstanding: 33,302,800 and 33,232,988 Ordinary
Shares as of
June 30, 2019 and December 31, 2018,
respectively
|
727
|
727
|
Additional paid-in
capital
|
196,871
|
194,642
|
Accumulated
deficit
|
(162,489)
|
(141,824)
|
TOTAL
SHAREHOLDERS' EQUITY
|
35,109
|
53,545
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
46,860
|
$
61,510
|
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
(Unaudited)
|
|
|
|
|
Three months
ended
June 30
|
Six months
ended
June 30
|
|
2019
|
2018
|
2019
|
2018
|
|
U.S.
dollars
in
thousands
|
U.S.
dollars
in
thousands
|
OPERATING
EXPENSES:
|
|
|
|
|
RESEARCH AND
DEVELOPMENT
EXPENSES, net
|
$
(7,860)
|
$
(8,400)
|
$
(16,402)
|
$
(17,280)
|
GENERAL AND
ADMINISTRATIVE
EXPENSES
|
(2,144)
|
(2,194)
|
(4,334)
|
(4,104)
|
OPERATING
LOSS
|
(10,004)
|
(10,594)
|
(20,736)
|
(21,384)
|
FINANCIAL INCOME
(EXPENSES), net
|
33
|
(292)
|
143
|
(168)
|
LOSS BEFORE
INCOME TAX
|
(9,971)
|
(10,886)
|
(20,593)
|
(21,552)
|
INCOME
TAX
|
(38)
|
(147)
|
(72)
|
(210)
|
NET
LOSS
|
$
(10,009)
|
$
(11,033)
|
$
(20,665)
|
$
(21,762)
|
|
$
|
$
|
LOSS PER SHARE
BASIC AND DILUTED
|
(0.30)
|
(0.34)
|
(0.62)
|
(0.75)
|
WEIGHTED AVERAGE
NUMBER OF SHARES
OUTSTANDING USED IN
COMPUTATION
OF BASIC AND DILUTED LOSS
PER
ORDINARY SHARE IN
THOUSANDS
|
33,300
|
32,086
|
33,274
|
29,114
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
SHAREHOLDERS' EQUITY
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary
Shares
|
Additional
paid-in
capital
|
Accumulated
Deficit
|
Total
|
|
Number
of shares
|
Amounts
|
Amounts
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2018
|
26,075,770
|
$
727
|
$
156,356
|
$
(98,281)
|
$
58,802
|
CHANGES IN THE
SIX-MONTH
PERIOD ENDED JUNE 30,
2018:
|
|
|
|
|
|
Issuance of ordinary
shares, net of
issuance costs
|
7,150,000
|
-
|
35,029
|
-
|
35,029
|
Exercise of
options
|
218
|
-
|
1
|
-
|
1
|
Share-based
compensation
|
-
|
-
|
1,601
|
-
|
1,601
|
Net loss
|
-
|
-
|
-
|
(21,762)
|
(21,762)
|
BALANCE AT JUNE
30, 2018
|
33,225,988
|
$
727
|
$
192,987
|
$
(120,043)
|
$
73,671
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2019
|
33,232,988
|
$
727
|
$
194,642
|
(141,824)
|
$
53,545
|
CHANGES IN THE
SIX-MONTH
PERIOD ENDED JUNE 30,
2019:
|
|
|
|
|
|
Exercise of
options
|
69,812
|
-
|
268
|
-
|
268
|
Share-based
compensation
|
|
-
|
1,961
|
-
|
1,961
|
Net loss
|
-
|
-
|
-
|
(20,665)
|
(20,665)
|
BALANCE AT JUNE
30, 2019
|
33,302,800
|
$
727
|
$
196,871
|
$
(162,489)
|
$
35,109
|
|
|
|
|
|
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
SHAREHOLDERS' EQUITY
|
(Unaudited)
|
|
|
|
|
|
|
|
Ordinary
Shares
|
Additional
paid-in
capital
|
Accumulated
Deficit
|
Total
|
|
Number
of shares
|
Amounts
|
Amounts
|
|
|
U.S. dollars in
thousands
|
BALANCE AT APRIL
1, 2018
|
26,075,770
|
$
727
|
$
157,079
|
$
(109,010)
|
$
48,796
|
CHANGES IN THE
THREE-MONTH
PERIOD ENDED JUNE 30,
2018:
|
|
|
|
|
|
Issuance of ordinary
shares, net of
issuance costs
|
7,150,000
|
-
|
35,029
|
-
|
35,029
|
Exercise of
options
|
218
|
-
|
1
|
-
|
1
|
Share-based
compensation
|
-
|
-
|
878
|
-
|
878
|
Net loss
|
-
|
-
|
-
|
(11,033)
|
(11,033)
|
BALANCE AT JUNE
30, 2018
|
33,225,988
|
$
727
|
$
192,987
|
$
(120,043)
|
$
73,671
|
|
|
|
|
|
|
BALANCE AT APRIL
1, 2019
|
33,297,371
|
$
727
|
$
195,842
|
(152,480)
|
$
44,089
|
CHANGES IN THE
THREE-
MONTH PERIOD ENDED JUNE
30, 2019:
|
|
|
|
|
|
Exercise of
options
|
5,429
|
-
|
11
|
-
|
11
|
Share-based
compensation
|
|
-
|
1,018
|
-
|
1,018
|
Net loss
|
-
|
-
|
-
|
(10,009)
|
(10,009)
|
BALANCE AT JUNE
30, 2019
|
33,302,800
|
$
727
|
$
196,871
|
$
(162,489)
|
$
35,109
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
|
(Unaudited)
|
|
|
|
Six months ended
June 30
|
|
2019
|
2018
|
|
U.S. dollars in
thousands
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net loss
|
$
(20,665)
|
$
(21,762)
|
Adjustments
required to reconcile net loss to net cash used in
operating activities:
|
|
|
Depreciation
|
431
|
416
|
Exchange differences
on cash and cash equivalents
|
(19)
|
(368)
|
Right of use
asset
|
351
|
-
|
Lease
liability
|
(243)
|
-
|
Losses (gains) on
marketable securities
|
(5)
|
154
|
Share-based
compensation
|
1,961
|
1,601
|
Changes in operating
assets and liabilities:
|
|
|
Increase in prepaid
expenses and other receivables
|
(136)
|
(502)
|
Increase in deferred
tax assets
|
(148)
|
-
|
Increase in accounts
payable and accruals
|
583
|
606
|
Increase in other
liabilities
|
163
|
-
|
Net cash used in
operating activities
|
(17,727)
|
(19,855)
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
Purchase of property
and equipment
|
(151)
|
(2,613)
|
Investment in other
assets
|
(1,435)
|
(1,696)
|
Proceeds from disposal
of marketable securities, net
|
576
|
1
|
Net cash used in
investing activities
|
(1,010)
|
(4,308)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from issuance
of ordinary shares, net of issuance
costs
|
-
|
35,029
|
Proceeds from exercise
of options
|
268
|
1
|
Net cash provided by
financing activities
|
268
|
35,030
|
DECREASE IN CASH
AND CASH EQUIVALENTS
|
(18,469)
|
10,867
|
CASH AND CASH
EQUIVALENTS AT BEGINNING OF
THE PERIOD
|
39,246
|
53,393
|
EXCHANGE
DIFFERENCES ON CASH AND CASH
EQUIVALENTS
|
19
|
368
|
CASH AND CASH
EQUIVALENTS AT END OF THE
PERIOD
|
$
20,796
|
$
64,628
|
|
|
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH
INVESTING AND FINANCING
ACTIVITIES:
|
|
|
Liability with
respect to property and equipment
|
$
502
|
$
1,740
|
Liability with
respect to other assets
|
$
1,114
|
$
-
|
|
|
|
SUPPLEMENTARY
DISCLOSURE OF CASH FLOW INFORMATION -
|
|
|
Taxes paid
|
$
50
|
$
31
|
Interest
received
|
$
263
|
$
209
|
Intec Pharma Investor Contact:
Anne Marie
Fields
VP-Corporate Communications & Investor
Relations
646-200-8808
amf@intec-us.com
View original
content:http://www.prnewswire.com/news-releases/intec-pharma-reports-second-quarter-2019-financial-results-and-business-update-300899233.html
SOURCE Intec Pharma Ltd.