JERUSALEM, May 7, 2019 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces financial
results for the three months ended March 31,
2019 and provides a corporate update.
Highlights of the first quarter 2019 and recent weeks
include:
- Announced that the last patient completed their final visit in
the Company's pivotal Phase 3 trial (the ACCORDANCE trial)
evaluating the safety and efficacy of the Accordion
Pill®-Carbidopa/Levodopa (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);
- Reported positive data from a pharmacokinetic (PK) study of
AP-CD/LD 50/500 mg in PD patients, demonstrating that AP-CD/LD when
dosed three times per day (TID) met the primary endpoint of
reducing plasma levodopa variability when compared to standard oral
CD/LD dosed five times per day (p=0.0048);
- Announced that data from the PK study of AP-CD/LD 50/500 mg TID
were accepted for poster presentation at the XXIV World Congress on
Parkinson's Disease and Related Disorders taking place June 16 -19, 2019 in Montreal, Canada;
- Completed the analysis of a PK study of AP-tetrahydrocannabinol
(THC), showing AP-THC to be generally safe and well tolerated, but
finding this particular AP structure, which was specifically
designed for this study, did not fully meet the Company's internal
expectations; and
- Initiated the PK study of the Accordion Pill developed for a
proprietary compound under the previously announced feasibility and
option agreement with Novartis Pharmaceuticals.
Management Commentary
"Since the beginning of 2019, we continued to execute on our
strategic initiatives to build our Accordion Pill platform
technology and advance our clinical development programs. We
are especially pleased with the progress we made with the AP-CD/LD
development program, which keeps us on track to report topline
results from this pivotal Phase 3 trial in advanced Parkinson's
patients this summer," stated Jeffrey A.
Meckler, Vice Chairman and Chief Executive Officer of Intec
Pharma.
"During the first quarter, we announced positive data from the
AP-CD/LD 50/500 mg TID PK study. These results were especially
encouraging as they demonstrated a statistically significant
reduction in plasma LD variability, which many Parkinson's disease
experts believe is a proxy for efficacy. These PK data using
the most common dose in our Phase 3 ACCORDANCE study are
encouraging and support our confidence in this pivotal program. We
look forward to having these favorable data presented at the World
Congress on Parkinson's Disease and Related Disorders next
month.
"We continue to make progress with our pre-commercial activities
for AP-CD/LD, with a view to enhancing partnership opportunities
for this late-stage asset. Our ongoing payor research confirms the
need for better baseline LD treatment and concluded that peak U.S.
base case annual gross revenues in excess of $300 million are possible with appropriate
pricing and access. Together with our partner, LTS
LohmanTherapie-Systeme, we made meaningful progress this last
quarter with our commercial scale manufacturing processes. In
the coming months, we intend to begin the validation,
bioequivalency and stability studies that are designed to position
us to file for regulatory submission and to support a commercial
launch. As a result, we remain confident we are on track to submit
a New Drug Application for approval of AP-CD/LD in mid- to
late-2020, assuming positive topline data.
"During the quarter, we were very excited to initiate the human
PK study of our AP for a Novartis propriety compound. Previously,
our Intec team successfully created a customized AP for Novartis'
proprietary compound that met the required in vitro
specifications set forth in our feasibility agreement. We
hope to take the next step in our relationship with Novartis with
this in vivo study. This partnership holds significant
promise as the market opportunity for this proprietary compound is
in excess of $1 billion.
"Regarding our cannabis development program, we were
disappointed that the initial custom designed AP delivery system in
the AP-THC PK study didn't meet our expectations. Our ongoing
development work provides a deeper understanding of how to best
apply gastric retention technology to enhance the delivery of this
poorly soluble class of molecules. Development of new AP designs is
an iterative process, and just as we did for the design of our
AP-CD/LD, we will continue to optimize the cannabinoid AP to fully
meet our specifications for the oral delivery of THC and CBD.
Moving forward, new designs of the AP will likely be required to
advance the cannabis program and we expect to provide new timelines
for the cannabinoid AP clinical development program before the end
of the year.
"With topline data readout expected in the coming months, we are
closer than ever to achieving our vision to bring a better baseline
levodopa treatment to Parkinson's patients suffering with the motor
complications of this degenerative disease. Before the end of
2019, we have two significant opportunities to monetize our
Accordion Pill platform assets: our PD program and our Novartis
partnership. Moving forward, we expect to build our Accordion
Pill drug delivery platform with the addition of both
partner-sponsored R&D programs, such as Novartis, and through
internally-led drug reformulation programs, such as our PD program.
We believe this strategy provides the best opportunities for both
short- and long-term growth," concluded Mr. Meckler.
First Quarter 2019 Financial Results
Research and development expenses, net, for the three-month
period ended March 31, 2019 were
approximately $8.5 million, a
decrease of approximately $400,000,
or 4%, compared with approximately $8.9
million for the first quarter of 2018. The decrease 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 March 31, 2019 were
approximately $2.2 million, an
increase of approximately $300,000,
or 16%, compared with approximately $1.9
million in the three-month period ended March 31, 2018. The increase 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 March 31, 2019 and 2018 was approximately
$10.7 million.
Loss per ordinary share for the three-month period ended
March 31, 2019 was $0.32 compared with a loss per ordinary share of
$0.41 for the three-month period
ended March 31, 2018.
As of March 31, 2019, the Company
had cash and cash equivalents and marketable securities of
approximately $32.3 million compared
with approximately $40.6 million at
December 31, 2018.
Net cash used in operating activities during the three-month
period ended March 31, 2019 was
approximately $7.3 million compared
with net cash used in operating activities of approximately
$10.3 million during the
three-month period ended March 31,
2018. This decrease resulted primarily from changes in
operating asset and liability items of approximately $2.6 million and a decrease in expenses paid in
cash in the current quarter compared to the three months ended
March 31, 2018.
The Company had negative cash flow from investing activities of
approximately $640,000 during the
three-month period ended March 31,
2019 compared to negative cash flow from investing
activities of approximately $2.0
million during the three-month period ended March 31, 2018. This decrease resulted primarily
from a decrease in purchase of property and equipment in the amount
of approximately $2.0 million and
proceeds from the disposal of marketable securities in the amount
of approximately $500,000. This was
offset by an approximate $1.2 million
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 three-month
period ended March 31, 2019 was
approximately $161,000, which was
provided by the proceeds from the exercise of options by employees.
During the three-month period ended March
31, 2018, the Company had no financing activities.
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.
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)
|
|
|
March
31
|
December
31
|
|
2019
|
2018
|
|
U.S.
dollars
in
thousands
|
Assets
|
|
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
$
31,497
|
$
39,246
|
Investment in
marketable securities
|
757
|
1,333
|
Prepaid expenses and
other receivables
|
2,685
|
2,986
|
TOTAL CURRENT
ASSETS
|
34,939
|
43,565
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
Other
assets
|
6,792
|
5,431
|
Property and
equipment, net
|
12,487
|
12,233
|
Operating lease
right-of-use assets
|
2,047
|
-
|
Deferred tax
assets
|
350
|
281
|
TOTAL NON-CURRENT
ASSETS
|
21,676
|
17,945
|
|
|
|
TOTAL
ASSETS
|
$
56,615
|
$
61,510
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
CURRENT
LIABILITIES -
|
|
|
Accounts payable and
accruals:
|
|
|
Trade
|
$
3,487
|
$
2,849
|
Other
|
7,245
|
4,807
|
TOTAL CURRENT
LIABILITIES
|
10,732
|
7,656
|
LONG-TERM
LIABILITIES -
|
|
|
Non-current operating lease liabilities
|
1,409
|
-
|
Other liabilities
|
385
|
309
|
TOTAL LONG-TERM
LIABILITIES
|
1,794
|
309
|
TOTAL
LIABILITIES
|
12,526
|
7,965
|
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
Ordinary
shares, with no par value - authorized: 100,000,000
Ordinary Shares as of March 31, 2019 and December 31,
2018; issued
and outstanding: 33,297,371 and 33,232,988 Ordinary
Shares as of
March 31, 2019 and December 31, 2018,
respectively
|
727
|
727
|
Additional paid-in
capital
|
195,842
|
194,642
|
Accumulated
deficit
|
(152,480)
|
(141,824)
|
TOTAL
SHAREHOLDERS' EQUITY
|
44,089
|
53,545
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
56,615
|
$
61,510
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
(Unaudited)
|
|
|
|
Three months
ended
March
31
|
|
2019
|
2018
|
|
U.S.
dollars
in
thousands
|
OPERATING
EXPENSES:
|
|
|
RESEARCH AND
DEVELOPMENT EXPENSES, net
|
$
(8,542)
|
$
(8,880)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(2,190)
|
(1,910)
|
OPERATING
LOSS
|
(10,732)
|
(10,790)
|
FINANCIAL
INCOME, net
|
110
|
124
|
LOSS BEFORE
INCOME TAX
|
(10,622)
|
(10,666)
|
INCOME
TAX
|
(34)
|
(63)
|
NET
LOSS
|
$
(10,656)
|
$
(10,729)
|
|
$
|
LOSS PER SHARE
BASIC AND DILUTED
|
$
(0.32)
|
$
(0.41)
|
WEIGHTED AVERAGE
NUMBER OF SHARES
OUTSTANDING USED IN COMPUTATION OF BASIC
AND DILUTED LOSS PER ORDINARY SHARE IN
THOUSANDS
|
33,247
|
26,076
|
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
THREE-
MONTH PERIOD ENDED
MARCH 31, 2018:
|
|
|
|
|
|
Share-based
compensation
|
-
|
-
|
723
|
-
|
723
|
Net loss
|
-
|
-
|
-
|
(10,729)
|
(10,729)
|
BALANCE AT MARCH
31, 2018
|
26,075,770
|
$
727
|
$
157,079
|
$
(109,010)
|
$
48,796
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2019
|
33,232,988
|
$
727
|
$
194,642
|
(141,824)
|
$
53,545
|
CHANGES IN THE
THREE-
MONTH PERIOD ENDED
MARCH 31, 2019:
|
|
|
|
|
|
Exercise of
options
|
64,383
|
-
|
257
|
-
|
257
|
Share-based
compensation
|
-
|
-
|
943
|
-
|
943
|
Net loss
|
-
|
-
|
-
|
(10,656)
|
(10,656)
|
BALANCE AT MARCH
31, 2019
|
33,297,371
|
$
727
|
$
195,842
|
$
(152,480)
|
$
44,089
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
|
(Unaudited)
|
|
|
Three months
ended
March
31
|
|
2019
|
2018
|
|
U.S. dollars in
thousands
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net loss
|
$
(10,656)
|
$
(10,729)
|
Adjustments
required to reconcile net loss to net cash used in
operating activities:
|
|
|
Depreciation
|
218
|
206
|
Exchange differences
on cash and cash equivalents
|
8
|
(40)
|
Right of use
asset
|
163
|
|
Lease
liability
|
(98)
|
-
|
Losses on marketable
securities
|
-
|
73
|
Share-based
compensation
|
943
|
723
|
Changes in operating
assets and liabilities:
|
|
|
Decrease (increase) in
prepaid expenses and other
receivables
|
340
|
(98)
|
Increase in deferred
tax assets
|
(69)
|
-
|
Increase (decrease) in
accounts payable and accruals
|
1,813
|
(390)
|
Increase in other
liabilities
|
76
|
-
|
Net cash used in
operating activities
|
(7,262)
|
(10,255)
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
Purchase of property
and equipment
|
(10)
|
(2,022)
|
Investment in other
assets
|
(1,206)
|
-
|
Proceeds from disposal
of marketable securities, net
|
576
|
46
|
Net cash used in
investing activities
|
(640)
|
(1,976)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from exercise
of options
|
161
|
-
|
Net cash provided by
financing activities
|
161
|
-
|
DECREASE IN CASH
AND CASH EQUIVALENTS
|
(7,741)
|
(12,231)
|
CASH AND CASH
EQUIVALENTS AT BEGINNING OF
THE PERIOD
|
39,246
|
53,393
|
EXCHANGE
DIFFERENCES ON CASH AND CASH
EQUIVALENTS
|
(8)
|
40
|
CASH AND CASH
EQUIVALENTS AT END OF THE
PERIOD
|
$
31,497
|
$
41,202
|
|
|
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH
INVESTING AND FINANCING
ACTIVITIES:
|
|
|
Liability with respect
to property and equipment
|
$
462
|
$
-
|
Liability with respect
to other assets
|
648
|
$
-
|
Receivables with
respect to exercise of options
|
$
96
|
$
-
|
|
|
|
SUPPLEMENTARY
DISCLOSURE OF CASH FLOW
INFORMATION:
|
|
|
Interest
received
|
$
128
|
$
117
|
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.