JERUSALEM, Aug. 5, 2020 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces financial
results for the second quarter ended June
30, 2020 and provides a corporate update.
"We have worked diligently over the past quarter to address the
challenges of an evolving landscape for both our business and
clinical development initiatives given the global COVID-19
pandemic," stated Jeffrey A.
Meckler, Vice Chairman and Chief Executive Officer of Intec
Pharma.
"Despite constraints on our ability to conduct in-person
meetings, our partnering activities to identify new opportunities
and compounds for our unique gastric retentive oral delivery system
as well as our partnering efforts for the AP-CD/LD program in
Parkinson's disease remain ongoing. Looking into the second half of
the year, we continue to seek to advance these productive
conversations towards a deal that demonstrates appropriate value
for both the Company and our shareholders.
"We look forward to advancing our newly designed AP-THC program
into clinical development later this year as we recently received
the active pharmaceutical ingredients needed for the clinical
material production.
"Earlier this year, we announced we met the in vitro
specifications for Merck's compound. At this time, we do not
anticipate the compound entering an in vivo study this year.
We continue to discuss development opportunities for the Accordion
Pill with Merck.
"Our recent registered direct offering not only strengthens our
balance sheet but, more importantly, provides the financial support
and flexibility to position the Company for its next stage of
development," added Mr. Meckler.
Financial Highlights for Second Quarter Ended June 30,
2020
Research and development expenses, net, for the three-month
period ended June 30, 2020 were approximately $1.3
million, a decrease of $6.6 million, or approximately 84%,
compared with approximately $7.9 million in the
three-month period ended June 30, 2019. Research and
development expenses, net, for the six-month period ended
June 30, 2020 were approximately
$3.3 million, a decrease of
approximately $13.1 million, or
approximately 80%, compared with approximately $16.4 million in the six-month period
ended June 30, 2019. The decrease was primarily due to the
completion of the ACCORDANCE study and Open Label Extension study
during 2019, decrease in expenses related to the scale up
activities for the commercial scale manufacturing and a decrease in
payroll and related expenses, mostly due to a reduction in
headcount, and share-based compensation.
General and administrative expenses for the three-month period
ended June 30, 2020 were approximately $1.6 million,
a decrease of $500,000, or approximately 24%, compared with
approximately $2.1 million in the three-month period
ended June 30, 2019. General and administrative expenses for
the six-month period ended June 30,
2020 amounted to approximately $3.3
million, a decrease of approximately $1.0 million, or approximately 23%, compared to
approximately $4.3 million for the
six-month ended June 30, 2019. The
decrease for the three and six-month periods was primarily related
to a decrease in payroll and related expenses, including reduction
in headcount, share-based compensation and reduction in associated
expenses.
Net loss for the three-month period ended June 30,
2020 was approximately $2.9 million, a decrease
of $7.1 million, or approximately 71%, compared with the net
loss for the three-month period ended June 30, 2019 of
approximately $10.0 million. The decrease for the three and
six-month periods was mainly due to a decrease in research and
development expenses, net, and general and administrative expenses,
as detailed above.
Loss per ordinary share for the three-month period
ended June 30, 2020, was $0.05 compared
with $0.30 for the three-month period ended June 30,
2019. Loss per ordinary share for the six-month period
ended June 30, 2020, was $0.12 compared
with $0.62 for the six-month period ended June 30,
2019.
As of June 30, 2020, the Company had cash and cash
equivalents of approximately $13.8 million. As of December 31, 2019, the Company had cash and cash
equivalents and marketable securities of approximately $10.1 million.
Net cash used in operating activities was
approximately $6.8 million for the six-month period
ended June 30, 2020 compared with net cash used in operating
activities of approximately $17.7 million for the
six-month period ended June 30, 2019. This decrease resulted
primarily from a decrease in research and development activities in
the amount of approximately $13.1
million, offset by changes in operating asset and liability
items of approximately $2.0 million.
The Company had positive cash flow from investing activities of
approximately $769,000 for the six-month period
ended June 30, 2020 compared to negative cash flow from
investing activities of approximately $1.0 for the six-month
period ended June 30, 2019. This change resulted primarily
from an investment in the establishment of the commercial scale
manufacturing in the amount of approximately $1.4 million in the six-month period
ended June 30, 2019 and an increase in proceeds from the
disposal of marketable securities in the amount of approximately
$200,000.
Net cash provided by financing activities for the six-month
period ended June 30, 2020 was
approximately $10.6 million, which
was provided primarily by the proceeds from the Company's
registered direct offering in May
2020 that resulted in net proceeds of approximately
$4.5 million, proceeds from the
company's underwritten public offering in February 2020 that resulted in net proceeds of
approximately $5.7 million and by the
funds received from the sale of our ordinary shares under the
Company's "at-the-market" equity offering program that resulted in
net proceeds of approximately $421,000.
In May 2020, the Company raised
$5.0 million in a registered direct
offering of 16,291,952 ordinary shares at a purchase price of
$0.3069 per share. In addition,
in a concurrent private placement, the Company also sold and issued
to the purchasers in the offering unregistered warrants to purchase
8,145,976 ordinary shares. The warrants have an exercise price
of $0.245 per share, are
immediately exercisable, and will expire five and one-half years
from the date of issuance.
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 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, the
impact of the outbreak of coronavirus, 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 March 13, 2020, and in
other filings that we have made and may make with
the Securities and Exchange Commission in the future.
Intec Pharma Investor Contact:
Will O'Connor
Stern IR
+1-212-362-1200
will@sternir.com
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
(Unaudited)
|
|
June
30,
|
December
31,
|
|
2020
|
2019
|
|
U.S.
dollars
|
in
thousands
|
|
|
|
Assets
|
|
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
$
13,799
|
$
9,292
|
Investment in
marketable securities
|
-
|
770
|
Prepaid expenses and
other receivables
|
1,307
|
3,683
|
|
|
|
TOTAL CURRENT
ASSETS
|
15,106
|
13,745
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
Property and equipment,
net
|
1,967
|
2,575
|
Operating lease
right-of-use assets
|
993
|
1,243
|
Other
assets
|
3,717
|
3,717
|
|
|
|
TOTAL NON-CURRENT
ASSETS
|
6,677
|
7,535
|
|
|
|
TOTAL
ASSETS
|
$
21,783
|
$
21,280
|
|
|
|
Liabilities
and shareholders' equity
|
|
|
CURRENT
LIABILITIES -
|
|
|
Accounts payable and
accruals:
|
|
|
Trade
|
$
382
|
$
3,507
|
Other
|
3,997
|
4,835
|
TOTAL CURRENT
LIABILITIES
|
4,379
|
8,342
|
|
|
|
LONG-TERM
LIABILITIES -
|
|
|
Non-current operating
lease liabilities
|
536
|
799
|
Other
liabilities
|
690
|
604
|
|
|
|
TOTAL LONG-TERM
LIABILITIES
|
1,226
|
1,403
|
|
|
|
TOTAL
LIABILITIES
|
5,605
|
9,745
|
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
|
|
|
SHAREHOLDERS'
EQUITY:
|
Ordinary shares, with
no par value - authorized: 100,000,000
Ordinary Shares as of June 30, 2020 and December 31, 2019;
issued
and outstanding: 69,428,032 and 35,892,209 Ordinary Shares as
of
June 30, 2020 and December 31, 2019, respectively
|
727
|
727
|
Additional
paid-in capital
|
211,691
|
200,231
|
Accumulated
deficit
|
(196,240)
|
(189,423)
|
|
|
|
TOTAL
SHAREHOLDERS' EQUITY
|
16,178
|
11,535
|
|
|
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
21,783
|
$
21,280
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
|
(Unaudited)
|
|
|
Three months
ended
June 30
|
Six months
ended
June 30
|
|
2020
|
2019
|
2020
|
2019
|
|
U.S.
dollars
in
thousands
|
U.S.
dollars
in
thousands
|
OPERATING
EXPENSES:
|
|
|
|
|
RESEARCH AND
DEVELOPMENT
EXPENSES, net
|
$
(1,275)
|
$
(7,860)
|
$
(3,299)
|
$
(16,402)
|
GENERAL AND
ADMINISTRATIVE
EXPENSES
|
(1,630)
|
(2,144)
|
(3,345)
|
(4,334)
|
OPERATING
LOSS
|
(2,905)
|
(10,004)
|
(6,644)
|
(20,736)
|
FINANCIAL INCOME
(EXPENSES), net
|
4
|
33
|
(66)
|
143
|
LOSS BEFORE
INCOME TAX
|
(2,901)
|
(9,971)
|
(6,710)
|
(20,593)
|
INCOME
TAX
|
(46)
|
(38)
|
(107)
|
(72)
|
NET
LOSS
|
$
(2,947)
|
$
(10,009)
|
$
(6,817)
|
$
(20,665)
|
|
$
|
$
|
LOSS PER SHARE
BASIC AND DILUTED
|
(0.05)
|
(0.30)
|
(0.12)
|
(0.62)
|
WEIGHTED AVERAGE
NUMBER OF SHARES
OUTSTANDING USED IN COMPUTATION
OF BASIC AND DILUTED LOSS PER
ORDINARY SHARE IN THOUSANDS
|
62,820
|
33,300
|
54,913
|
33,274
|
(Continued) -
1
|
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, 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
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2020
|
35,892,209
|
$
727
|
$
200,231
|
$
(189,423)
|
$
11,535
|
CHANGES IN THE
SIX-MONTH PERIOD
ENDED JUNE 30, 2020:
|
|
|
|
|
|
Issuance of ordinary
shares, net of
issuance
costs
|
831,371
|
-
|
421
|
-
|
421
|
Issuance of ordinary
shares and
warrants, net of issuance of
costs
|
16,250,000
|
-
|
5,692
|
-
|
5,692
|
Issuance of ordinary
shares and
warrants, net of issuance of
costs
|
16,291,952
|
-
|
4,426
|
-
|
4,426
|
Exercise
of warrants
|
162,500
|
|
65
|
|
65
|
Share-based
compensation
|
-
|
-
|
856
|
-
|
856
|
Net loss
|
-
|
-
|
-
|
(6,817)
|
(6,817)
|
BALANCE AT JUNE
30, 2020
|
69,428,032
|
$
727
|
$
211,691
|
$
(196,240)
|
$
16,178
|
(Continued) -
2
|
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, 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
|
|
|
|
|
|
|
BALANCE AT APRIL
1, 2020
|
52,973,580
|
$
727
|
$
206,786
|
$
(193,293)
|
$
14,220
|
CHANGES IN THE
THREE-MONTH PERIOD
ENDED JUNE 30, 2020:
|
|
|
|
|
|
Issuance of ordinary shares and
|
16,291,952
|
-
|
4,426
|
-
|
4,426
|
warrants, net of
issuance costs
|
Exercise of
warrants
|
162,500
|
-
|
65
|
-
|
65
|
Share-based
compensation
|
-
|
-
|
414
|
-
|
414
|
Net loss
|
-
|
-
|
-
|
(2,947)
|
(2,947)
|
BALANCE AT JUNE
30, 2020
|
69,428,032
|
$
727
|
$
211,691
|
$
(196,240)
|
$
16,178
|
INTEC PHARMA
LTD.
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
(Unaudited)
|
|
|
Six months ended
June 30
|
|
2020
|
2019
|
|
U.S. dollars in
thousands
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net loss
|
$
(6,817)
|
$
(20,665)
|
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation
|
611
|
431
|
Exchange differences
on cash and cash equivalents
|
49
|
(19)
|
Change in right of use
asset
|
250
|
351
|
Change in lease
liabilities
|
(263)
|
(243)
|
Gains on marketable
securities
|
(2)
|
(5)
|
Share-based
compensation
|
856
|
1,961
|
Changes in operating
assets and liabilities:
|
|
|
Decrease (increase) in
prepaid expenses and other receivables
|
2,376
|
(136)
|
Increase in deferred
tax assets
|
-
|
(148)
|
Increase (decrease) in
accounts payable and accruals
|
(3,963)
|
583
|
Increase in other
liabilities
|
86
|
163
|
Net cash used in
operating activities
|
(6,817)
|
(17,727)
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
Purchase of property
and equipment
|
(3)
|
(151)
|
Investment in other
assets
|
-
|
(1,435)
|
Proceeds from disposal
of marketable securities, net
|
772
|
576
|
Net cash provided by
(used in) investing activities
|
769
|
(1,010)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from issuance
of ordinary shares, net of issuance costs
|
421
|
-
|
Proceeds from issuance
of ordinary shares and warrants, net of issuance costs
|
5,692
|
-
|
Proceeds from issuance
of ordinary shares and warrants, net of issuance costs
|
4,426
|
-
|
Proceeds from exercise
of warrants
|
65
|
-
|
Proceeds from exercise
of options
|
-
|
268
|
Net cash provided by
financing activities
|
10,604
|
268
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
4,556
|
(18,469)
|
CASH AND CASH
EQUIVALENTS AT BEGINNING OF THE PERIOD
|
9,292
|
39,246
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(49)
|
19
|
CASH AND CASH
EQUIVALENTS AT END OF THE PERIOD
|
$
13,799
|
$
20,796
|
|
|
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
|
|
Liability with respect
to property and equipment
|
-
|
$
502
|
Liability with respect
to other assets
|
-
|
$
1,114
|
|
|
|
SUPPLEMENTARY
DISCLOSURE OF CASH FLOW INFORMATION -
|
|
|
Taxes paid
|
-
|
$
50
|
Interest
received
|
$
27
|
$
263
|
View original
content:http://www.prnewswire.com/news-releases/intec-pharma-reports-second-quarter-2020-financial-results-and-provides-corporate-update-301106454.html
SOURCE Intec Pharma Ltd.