JERUSALEM, Nov. 9, 2018 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces financial
results for the three and nine months ended September 30, 2018 and provides a corporate
update.
Highlights of the third quarter 2018 and recent weeks
include:
- Reported completion of global enrollment in the pivotal Phase 3
ACCORDANCE clinical trial of Accordion Pill™ Carbidopa/Levodopa
(AP-CD/LD) for the treatment of advanced Parkinson's disease
patients;
- Announced that more than 90% of eligible patients from the
ACCORDANCE clinical trial are opting to participate in the Open
Label Extension (OLE) study;
- Initiated the pharmacokinetic (PK) study of AP-CD/LD 50/500 mg
dosed three times per day (TID) in advanced Parkinson's disease
patients;
- Presented multiple poster presentations at the International
Parkinson and Movement Society (MDS) annual meeting in early
October; and
- Voluntarily delisted from the Tel Aviv Stock Exchange; trading
solely on the NASDAQ Capital Market.
Management Commentary
"Throughout the third quarter, we continued to make significant
progress across a number of key areas important to advancing our AP
platform and for building Intec Pharma into a leading drug delivery
company," stated Jeffrey A. Meckler,
Vice Chairman and Chief Executive Officer of Intec
Pharma.
"We recently reported the completion of enrollment in our
pivotal Phase 3 clinical trial of AP-CD/LD, which keeps us on track
to report topline data in mid-2019. We remain encouraged by
the continued strong participation in our OLE study, which gives us
confidence that these data will be available in the second half of
2019 and will provide the long-term safety data required for our
regulatory submission. We expect to have data from the PK
study of AP-CD/LD 50/500 mg TID by year-end and believe these data
will be important as this is a popular dosing regimen in the
ACCORDANCE study and having this PK information will be of interest
to potential partners and clinicians upon commercial launch. Last
month, the three posters presented at MDS related to our platform
and the Phase 3 development program for AP-CD/LD were very well
received. We are delighted with the growing interest among
clinicians and industry experts in this pivotal program to bring an
innovative new baseline levodopa to Parkinson's disease patients in
need of a better baseline therapy. Additionally, we are encouraged
by the number of inquiries we are receiving
from prospective commercial partners regarding this
potentially best-in-class therapy.
"As we approach completion of our Phase 3 program in Parkinson's
disease, we remain focused on advancing a number of important
commercial activities that will support regulatory submission and
product launch. Our ongoing market assessment continues to strongly
support our value proposition and potential market
opportunity. The commercial manufacturing project with our
partner, LTS Lohmann Therapie-Systeme AG (LTS) is advancing as
planned with delivery of the commercial scale manufacturing machine
expected by year-end. Thereafter, we will provide timelines for the
validation, bridging and stability studies for the commercial
manufacturing process.
"We are also investing in and building out our next phase of
growth through the AP platform's innovation engine that can provide
multiple opportunities for further in-house development programs
and partnerships. To that end, we look forward to advancing our AP
cannabinoid program with the initiation of a PK study of AP-THC by
year-end and to continuing our work with Novartis on the
feasibility study underway. We are encouraged by advancements
in our AP-THC, AP-CBD and Novartis programs and will continue to
seek new additions to our intellectual property portfolio from this
work.
"We anticipate achieving a number of milestones in the fourth
quarter that we expect will strengthen our value proposition and
position us for continued growth throughout the balance of 2018 and
beyond," concluded Mr. Meckler.
Financial Highlights for the Three and Nine Months
Ended September 30, 2018
Research and development expenses, net, for the three-month
period ended September 30, 2018 were
approximately $7.8 million, an increase of $1.9 million,
or approximately 32%, compared with approximately $5.9
million in the three-month period ended September 30,
2017. Research and development expenses, net, for the nine-month
period ended September 30, 2018 were
approximately $25.1 million, an increase of $9.7 million,
or approximately 63%, compared with approximately $15.4
million in the nine-month period ended September 30,
2017. The increase in both periods was primarily due to an increase
in expenses related to the progression of our Phase 3 ACCORDANCE
clinical trial for AP-CD/LD, expenses related to the establishment
of the commercial scale production capabilities for AP-CD/LD, share
based compensation to employees and payroll and related expenses,
mostly due to an increase in headcount.
General and administrative expenses for the three-month period
ended September 30, 2018 were approximately $1.7
million, an increase of $200,000, or approximately 13%,
compared with approximately $1.5 million in the
three-month period ended September 30, 2017. The increase was
primarily related to the increase in share-based compensation to
employees and payroll and related expenses primarily related to the
hiring of personnel in the United States.
General and administrative expenses for the nine-month period
ended September 30, 2018 were approximately $5.8
million, an increase of $2.2 million, or approximately 61%,
compared with approximately $3.6 million in the
nine-month period ended September 30, 2017. The increase was
primarily due to the increase in share-based compensation to
employees and payroll and related expenses primarily related to the
hiring of personnel in the United
States, professional services, expenses related to investor
relations activities and travel expenses.
Loss and comprehensive loss for the three-month period
ended September 30, 2018 was approximately $9.2
million, an increase of $1.5 million, or approximately 19%,
compared with the loss and comprehensive loss for the three-month
period ended September 30, 2017 of
approximately $7.7 million. Loss and comprehensive loss for
the nine-month period ended September 30, 2018 was
approximately $30.9 million, an increase of $12.0
million, or approximately 63%, compared with the loss and
comprehensive loss for the nine-month period ended September
30, 2017 of approximately $18.9 million. The increase in
both periods was mainly due to an increase in research and
development expenses and general and administrative
expenses as detailed above.
Loss per ordinary share for the nine-month period
ended September 30, 2018 was $1.01 compared
with $1.27 for the nine-month period ended September
30, 2017.
As of September 30, 2018, the Company had cash and cash
equivalents and financial assets at fair value through profit or
loss of approximately $54.5 million compared with
approximately $55.2 million at December 31, 2017.
The Company used net cash of approximately $31.0 million in
operating activities and approximately $5.2
million in investing activities during the
nine-month period ended September 30, 2018, primarily for the
Phase 3 ACCORDANCE trial, the establishment of the commercial scale
production capabilities for AP-CD/LD and repayment of
the Israeli Innovation Authority grants, which was offset
by a public offering with net proceeds of approximately $35.0
million that took place in April 2018
and exchange differences in cash and cash equivalents of
approximately $533,000.
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.
For more information, visit www.intecpharma.com.
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 20-F
filed with the SEC on March 9, 2018, and in other
filings that we have made and may make with the Securities and
Exchange Commission in the future.
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|
(Unaudited)
|
|
|
|
|
December
31,
|
September
30,
|
|
2017
|
2018
|
|
U.S. dollars in
thousands
|
A s s e t
s
|
|
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
53,324
|
52,733
|
Financial assets at
fair value through profit or loss
|
1,825
|
1,722
|
Restricted bank
deposits
|
69
|
149
|
Other
receivables
|
1,125
|
2,104
|
TOTAL CURRENT
ASSETS
|
56,343
|
56,708
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
Other
assets
|
-
|
2,694
|
Property and
equipment
|
8,206
|
12,097
|
TOTAL NON-CURRENT
ASSETS
|
8,206
|
14,791
|
|
|
|
TOTAL
ASSETS
|
64,549
|
71,499
|
|
|
|
Liabilities and
equity
|
|
|
CURRENT
LIABILITIES -
|
|
|
Accounts payable and
accruals:
|
|
|
Trade
|
1,854
|
1,742
|
Other
|
3,893
|
4,413
|
TOTAL CURRENT
LIABILITIES
|
5,747
|
6,155
|
|
|
|
NON-CURRENT
LIABILITIES -
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
|
|
|
EQUITY:
|
|
|
Ordinary
shares
|
727
|
727
|
Share
premium
|
148,968
|
183,998
|
Currency translation
differences
|
(378)
|
(378)
|
Accumulated
deficit
|
(90,515)
|
(119,003)
|
TOTAL
EQUITY
|
58,802
|
65,344
|
TOTAL LIABILITIES
AND EQUITY
|
64,549
|
71,499
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
(Unaudited)
|
|
|
|
|
Three months
ended
|
Nine months
ended
|
|
September
30
|
September
30
|
|
2017
|
2018
|
2017
|
2018
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
(5,888)
|
(7,901)
|
(15,426)
|
(25,639)
|
LESS -
PARTICIPATION IN RESEARCH AND
DEVELOPMENT EXPENSES
|
-
|
92
|
-
|
550
|
RESEARCH AND
DEVELOPMENT EXPENSES, net
|
(5,888)
|
(7,809)
|
(15,426)
|
(25,089)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(1,480)
|
(1,696)
|
(3,566)
|
(5,800)
|
OTHER GAINS
(LOSSES), net
|
(5)
|
13
|
166
|
(141)
|
OPERATING
LOSS
|
(7,373)
|
(9,492)
|
(18,826)
|
(31,030)
|
FINANCIAL
INCOME
|
29
|
254
|
209
|
643
|
FINANCIAL
EXPENSES
|
(308)
|
(104)
|
(240)
|
(507)
|
FINANCIAL INCOME
(EXPENSES), net
|
(279)
|
150
|
(31)
|
136
|
LOSS BEFORE TAXES
ON INCOME
|
(7,652)
|
(9,342)
|
(18,857)
|
(30,894)
|
TAXES ON
INCOME
|
-
|
164
|
-
|
(46)
|
LOSS AND
COMPREHENSIVE LOSS
|
(7,652)
|
(9,178)
|
(18,857)
|
(30,940)
|
|
|
|
|
|
|
|
$
|
|
|
BASIC AND DILUTED
LOSS PER ORDINARY
SHARE
|
(0.40)
|
(0.28)
|
(1.27)
|
(1.01)
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY
|
(Unaudited)
|
|
|
Ordinary
shares
|
|
|
|
|
|
|
Issued
|
|
|
|
|
|
|
and
|
|
|
|
|
|
|
paid-up
|
|
Currency
|
|
|
|
Number
of
|
share
|
Share
|
translation
|
Accumulated
|
|
|
shares
|
capital
|
premium
|
differences
|
deficit
|
Total
|
|
|
U.S. dollars in
thousands
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2017
|
11,448,191
|
727
|
84,980
|
(378)
|
(62,625)
|
22,704
|
CHANGES IN THE
NINE MONTH PERIOD
ENDED SEPTEMBER 30,
2017:
|
|
|
|
|
|
|
Proceeds from issuance
of shares, net of issuance
costs
|
14,514,138
|
-
|
63,131
|
-
|
-
|
63,131
|
Exercise of warrants
as part of an investment
agreement
|
102,058
|
-
|
812
|
-
|
-
|
812
|
Share-based
compensation
|
-
|
-
|
-
|
-
|
914
|
914
|
Exercise of options by
employees
|
5,064
|
-
|
19
|
-
|
-
|
19
|
Comprehensive
loss
|
-
|
-
|
-
|
-
|
(18,857)
|
(18,857)
|
BALANCE AT
SEPTEMBER 30, 2017
|
26,069,451
|
727
|
148,942
|
(378)
|
(80,568)
|
68,723
|
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2018
|
26,075,770
|
727
|
148,968
|
(378)
|
(90,515)
|
58,802
|
CHANGES IN THE
NINE MONTH PERIOD
ENDED SEPTEMBER 30,
2018:
|
|
|
|
|
|
|
Proceeds of issuance
shares, net of issuance costs
|
7,150,000
|
-
|
35,029
|
-
|
-
|
35,029
|
Share-based
compensation
|
-
|
-
|
-
|
-
|
2,452
|
2,452
|
Exercise of options by
employees
|
218
|
-
|
1
|
-
|
-
|
1
|
Comprehensive
loss
|
-
|
-
|
-
|
-
|
(30,940)
|
(30,940)
|
BALANCE AT
SEPTEMBER 30, 2018
|
33,225,988
|
727
|
183,998
|
(378)
|
(119,003)
|
65,344
|
|
|
|
|
|
|
|
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
|
(Unaudited)
|
|
|
Nine months
ended
|
|
September
30
|
|
2017
|
2018
|
|
U.S.
dollars
|
|
in
thousands
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Comprehensive
loss
|
(18,857)
|
(30,940)
|
Adjustments to
reconcile loss and comprehensive loss to net cash
used in operating activities (see
appendix A)
|
3,897
|
(9)
|
Net cash used in
operating activities
|
(14,960)
|
(30,949)
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
Purchase of property
and equipment
|
(2,447)
|
(2,632)
|
Investments in other
assets
|
-
|
(2,450)
|
Proceeds from disposal
(acquisition) of financial assets at fair value
through profit or loss,
net
|
254
|
(38)
|
Changes in restricted
bank deposits, net
|
-
|
(85)
|
Proceeds from sale of
property and equipment
|
7
|
-
|
Net cash used in
investing activities
|
(2,186)
|
(5,205)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Issuance of shares,
net of issuance costs
|
63,131
|
35,029
|
Exercise of warrants
as part of an investment agreement
|
531
|
-
|
Exercise of options by
employees
|
19
|
1
|
Net cash provided by
financing activities
|
63,681
|
35,030
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
46,535
|
(1,124)
|
CASH AND CASH
EQUIVALENTS - BEGINNING OF PERIOD
|
16,376
|
53,324
|
EXCHANGE
DIFFERENCES ON CASH AND CASH
EQUIVALENTS
|
66
|
533
|
CASH AND CASH
EQUIVALENTS - END OF PERIOD
|
62,977
|
52,733
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
|
(Unaudited)
|
|
|
|
Nine months
ended
|
|
September
30
|
|
2017
|
2018
|
|
U.S.
dollars
|
|
in
thousands
|
APPENDIX
A:
|
|
Adjustments to
reconcile loss and comprehensive loss to
net cash used in operating
activities:
|
|
|
Income and expenses
not involving cash flows:
|
|
|
Depreciation
|
613
|
639
|
Changes in the fair
value of derivative financial instruments
|
184
|
-
|
Exchange differences
on cash and cash equivalents
|
(66)
|
(533)
|
Exchange differences
on restricted deposits
|
(6)
|
5
|
Losses (gains) on
financial assets at fair value through profit
or loss
|
(168)
|
141
|
Loss on sale of
property and equipment
|
2
|
-
|
Share-based
compensation
|
914
|
2,452
|
|
1,473
|
2,704
|
Changes in operating
asset and liability items:
|
|
|
Decrease (increase) in
other receivables
|
1,051
|
(979)
|
Increase (decrease) in
accounts payable and accruals
|
1,373
|
(1,734)
|
|
2,424
|
(2,713)
|
|
3,897
|
(9)
|
APPENDIX
B:
|
|
|
Information regarding
investment and financing activities not
involving cash flows:
|
|
|
Liability with respect
to property purchase
|
30
|
1,898
|
Liability with respect
to other assets
|
-
|
244
|
Settlement of
liability in respect to derivative financial
instrument to equity
|
281
|
-
|
Supplementary
information to the statement of cash flows:
|
|
|
Taxes paid
|
-
|
31
|
Interest
received
|
99
|
522
|
Intec Pharma Investor Contact:
Anne Marie
Fields
VP-Corporate Communications & Investor Relations
646-200-8808
amf@intec-us.com
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SOURCE Intec Pharma Ltd.