JERUSALEM, Nov. 5, 2020 /PRNewswire/ -- Intec Pharma Ltd.
(NASDAQ: NTEC) ("Intec" or "the Company") today announces financial
results for the third quarter ended September 30, 2020 and provides a corporate
update.
"We maintain our focus on executing strategic partnerships and
collaborations. As such, we were delighted in recent weeks to
announce a new research collaboration with Merck. While we are
unable to provide the specifics of the agreement, it speaks to
Merck's keen understanding of the Accordion Pill (AP) technology
and their continued interest in working with us to realize its
potential," stated Jeffrey A.
Meckler, Vice Chairman and Chief Executive Officer of Intec
Pharma.
"In addition, we continue to innovate and progress our next
generation gastric retentive technologies. We are working on
a variety of new approaches to meet unmet needs such as a
once-a-day gastric retentive Accordion Pill."
"We also look forward to advancing our newly designed AP-THC
program into clinical development by year-end as we now have the
active pharmaceutical ingredients needed for the clinical material
production."
"Importantly, we strengthened our balance sheet during the third
quarter which allows us to move our AP-THC program forward, advance
our discussions with potential business parters and to support the
initiation of future collaborations, such as the one with Merck,"
added Mr. Meckler.
Financial Highlights for Third Quarter Ended September
30, 2020
Research and development expenses, net, for the three-month
period ended September 30, 2020 were
approximately $2.1 million, a decrease of $6.3 million,
or approximately 75%, compared with approximately $8.4
million in the three-month period ended September 30,
2019. Research and development expenses, net, for the nine-month
period ended September 30, 2020 were
approximately $5.4 million, a
decrease of approximately $19.5
million, or approximately 80%, compared with approximately
$24.9 million in the nine-month
period ended September 30, 2019. The decrease for the three
and nine-month periods was primarily due to the completion of the
ACCORDANCE study and Open Label Extension study during 2019, a
decrease in expenses related to the scale up activities of the
commercial scale manufacturing line, a decrease in payroll and
related expenses, mostly due to reduction in headcount, and a
decrease in share-based compensation.
General and administrative expenses for the three-month period
ended September 30, 2020 were approximately $1.5
million, a decrease of $700,000, or approximately 32%,
compared with approximately $2.2 million in the
three-month period ended September 30, 2019. General and
administrative expenses for the nine-month period ended
September 30, 2020 amounted to
approximately $4.9 million, a
decrease of approximately $1.6
million, or approximately 25%, compared to approximately
$6.5 million for the nine-month
period ended September 30, 2019. The
decrease for the three and nine-month periods was primarily related
to a decrease in payroll and related expenses, including reduction
in headcount, a decrease in share-based compensation and reduction
in associated expenses.
Net loss for the three-month period ended September 30,
2020 was approximately $3.7 million, a decrease
of $16.7 million, or approximately 82%, compared with the net
loss for the three-month period ended September 30, 2019 of
approximately $20.4 million. Net loss for the nine-month
period ended September 30, 2020 was
approximately $10.6 million, a decrease of $30.4 million,
or approximately 74%, compared with the net loss for the nine-month
period ended September 30, 2019 of
approximately $41.0 million. The decrease for the three and
nine-month periods was mainly due to a decrease in research and
development expenses, net, and general and administrative expenses,
as detailed above, and an impairment charge incurred in 2019.
Loss per ordinary share for the three-month period
ended September 30, 2020, was $0.95 compared
with $12.16 for the three-month period
ended September 30, 2019. Loss per ordinary share for the
nine-month period ended September 30,
2020, was $3.35 compared with $24.61 for the
nine-month period ended September 30, 2019.
As of September 30, 2020, the Company had cash and cash
equivalents of approximately $17.1 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 $8.9 million for the nine-month period
ended September 30, 2020 compared with net cash used in
operating activities of approximately $23.9 million for
the nine-month period ended September 30, 2019. This decrease
resulted primarily from a decrease in research and development
activities in the amount of approximately $19.4 million, offset by changes in operating
asset and liability items of approximately $4.1 million.
The Company had positive cash flow from investing activities of
approximately $756,000 for the nine-month period
ended September 30, 2020 compared to negative cash flow from
investing activities of approximately $2.5 million for the
nine-month period ended September 30, 2019. This change
resulted primarily from an investment in the establishment of the
commercial scale manufacturing line in the amount of approximately
$2.3 million in the nine-month period
ended September 30, 2019 and an
increase in purchase of property and equipment in the amount of
approximately $775,000.
Net cash provided by financing activities for the nine-month
period ended September 30, 2020 was
approximately $15.9 million, which
was provided primarily by the proceeds from the Company's
registered direct offering in August
2020 that resulted in net proceeds of approximately
$4.6 million, proceeds from the
Company's registered direct offering in May
2020 that resulted in net proceeds of approximately
$4.5 million, and proceeds from the
Company's underwritten public offering in February 2020 that resulted in net proceeds of
approximately $5.7 million.
In August 2020, the Company raised $4.9
million in a registered direct offering of
356,250 ordinary shares at a purchase price of $7.022 per
share. In addition, the Company also sold and issued to the
purchasers in the offering pre-funded warrants to purchase
356,250 ordinary shares at a purchase price of $6.822 per
share. The pre-funded warrants have an exercise price
of $0.20 per share, are immediately exercisable, and may
be exercised at any time until all of the pre-funded warrants are
exercised in full.
On October 30, 2020, we effected a
1-for-20 reverse share split. All share and per share amounts have
been retroactively adjusted to reflect the reverse share split.
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)
|
|
|
|
|
September 30,
|
December
31,
|
|
2020
|
2019
|
|
U.S.
dollars
in
thousands
|
|
|
|
Assets
|
|
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
$
17,076
|
$
9,292
|
Investment in
marketable securities
|
-
|
770
|
Prepaid expenses and
other receivables
|
609
|
3,683
|
TOTAL CURRENT
ASSETS
|
17,685
|
13,745
|
|
|
|
NON-CURRENT
ASSETS:
|
|
|
Property and
equipment, net
|
1,680
|
2,575
|
Operating lease
right-of-use assets
|
954
|
1,243
|
Other
assets
|
3,717
|
3,717
|
TOTAL NON-CURRENT
ASSETS
|
6,351
|
7,535
|
|
|
|
TOTAL
ASSETS
|
$
24,036
|
$
21,280
|
|
|
|
Liabilities and
shareholders' equity
|
|
|
CURRENT
LIABILITIES -
|
|
|
Accounts payable and
accruals:
|
|
|
Trade
|
$
531
|
$
3,507
|
Other
|
4,019
|
4,835
|
TOTAL CURRENT
LIABILITIES
|
4,550
|
8,342
|
LONG-TERM
LIABILITIES -
|
|
|
Non-current operating lease liabilities
|
458
|
799
|
Other liabilities
|
951
|
604
|
TOTAL LONG-TERM
LIABILITIES
|
1,409
|
1,403
|
TOTAL
LIABILITIES
|
5,959
|
9,745
|
|
|
|
COMMITMENTS AND
CONTINGENT LIABILITIES
|
|
|
SHAREHOLDERS'
EQUITY:
|
|
|
Ordinary
shares, with no par value - authorized: 17,500,000 and
5,000,000 Ordinary Shares as of September 30,
2020 and December
31, 2019, respectively; issued and outstanding:
3,948,226 and
1,794,611 Ordinary Shares as of September 30, 2020 and
December 31,
2019, respectively
|
727
|
727
|
Additional paid-in
capital
|
217,330
|
200,231
|
Accumulated
deficit
|
(199,980)
|
(189,423)
|
TOTAL
SHAREHOLDERS' EQUITY
|
18,077
|
11,535
|
TOTAL LIABILITIES
AND SHAREHOLDERS' EQUITY
|
$
24,036
|
$
21,280
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
(Unaudited)
|
|
|
Three months
ended
September 30
|
Nine months
ended
September 30
|
|
2020
|
2019
|
2020
|
2019
|
|
U.S.
dollars
in
thousands
|
U.S.
dollars
in
thousands
|
OPERATING
EXPENSES:
|
|
|
|
|
RESEARCH AND
DEVELOPMENT EXPENSES, net
|
$
(2,112)
|
$
(8,448)
|
$
(5,411)
|
$
(24,850)
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
(1,529)
|
(2,157)
|
(4,874)
|
(6,491)
|
IMPAIRMENT OF
LONG-LIVED ASSETS
|
-
|
(9,759)
|
-
|
(9,759)
|
OPERATING
LOSS
|
(3,641)
|
(20,364)
|
(10,285)
|
(41,100)
|
FINANCIAL INCOME
(EXPENSES), net
|
(57)
|
14
|
(123)
|
157
|
LOSS BEFORE
INCOME TAX
|
(3,698)
|
(20,350)
|
(10,408)
|
(40,943)
|
INCOME
TAX
|
(42)
|
(28)
|
(149)
|
(100)
|
NET
LOSS
|
$
(3,740)
|
$
(20,378)
|
$
(10,557)
|
$
(41,043)
|
|
U.S.
dollars
|
LOSS PER SHARE
BASIC AND DILUTED
|
$
(0.95)
|
$
(12.16)
|
$
(3.35)
|
$
(24.61)
|
WEIGHTED AVERAGE
NUMBER OF SHARES
OUTSTANDING USED IN COMPUTATION
OF BASIC AND DILUTED LOSS PER
ORDINARY SHARE IN THOUSANDS
|
3,952
|
1,676
|
3,153
|
1,668
|
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
|
1,661,649
|
$
727
|
$
194,642
|
$
(141,824)
|
$
53,545
|
CHANGES IN THE
NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2019:
|
|
|
|
|
|
Issuance of ordinary
shares, net of issuance costs
|
85,834
|
-
|
1,969
|
-
|
1,969
|
Exercise of
options
|
3,491
|
-
|
268
|
-
|
268
|
Share-based
compensation
|
|
-
|
2,748
|
-
|
2,748
|
Net loss
|
-
|
-
|
-
|
(41,043)
|
(41,043)
|
BALANCE AT
SEPTEMBER 30, 2019
|
1,750,974
|
$
727
|
$
199,627
|
$
(182,867)
|
$
17,487
|
|
|
|
|
|
|
BALANCE AT JANUARY
1, 2020
|
1,794,611
|
$
727
|
$
200,231
|
$
(189,423)
|
$
11,535
|
CHANGES IN THE
NINE-MONTH PERIOD ENDED SEPTEMBER 30, 2020:
|
|
|
|
|
|
Issuance of ordinary
shares, net of issuance costs
|
41,569
|
-
|
421
|
-
|
421
|
Issuance of ordinary
shares and warrants, net of issuance costs
|
812,500
|
-
|
5,692
|
-
|
5,692
|
Issuance of ordinary
shares and warrants, net of issuance costs
|
814,598
|
-
|
4,426
|
-
|
4,426
|
Issuance of ordinary
shares and pre-funded warrants, net of issuance costs
|
356,250
|
-
|
4,599
|
-
|
4,599
|
Exercise of
warrants
|
128,698
|
|
769
|
|
769
|
Share-based
compensation
|
-
|
-
|
1,192
|
-
|
1,192
|
Net loss
|
-
|
-
|
-
|
(10,557)
|
(10,557)
|
BALANCE AT
SEPTEMBER 30, 2020
|
3,948,226
|
$
727
|
$
217,330
|
$
(199,980)
|
$
18,077
|
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 JULY 1,
2019
|
1,665,140
|
$
727
|
$
196,871
|
$
(162,489)
|
$
35,109
|
CHANGES IN THE
THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2019:
|
|
|
|
|
|
Issuance of ordinary
shares, net of issuance costs
|
85,834
|
-
|
1,969
|
-
|
1,969
|
Share-based
compensation
|
-
|
-
|
787
|
-
|
787
|
Net loss
|
-
|
-
|
-
|
(20,378)
|
(20,378)
|
BALANCE AT
SEPTEMBER 30, 2019
|
1,750,974
|
$
727
|
$
199,627
|
$
(182,867)
|
$
17,487
|
|
|
|
|
|
|
BALANCE AT JULY 1,
2020
|
3,471,403
|
$
727
|
$
211,691
|
$
(196,240)
|
$
16,178
|
CHANGES IN THE
THREE-MONTH PERIOD ENDED SEPTEMBER 30, 2020:
|
|
|
|
|
|
Issuance of ordinary
shares and pre-funded warrants, net of issuance costs
|
356,250
|
-
|
4,599
|
-
|
4,599
|
Exercise of
warrants
|
120,573
|
|
704
|
|
704
|
Share-based
compensation
|
-
|
-
|
336
|
-
|
336
|
Net loss
|
-
|
-
|
-
|
(3,740)
|
(3,740)
|
BALANCE AT
SEPTEMBER 30, 2020
|
3,948,226
|
$
727
|
$
217,330
|
$
(199,980)
|
$
18,077
|
INTEC
PHARMA LTD.
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
|
(Unaudited)
|
|
|
|
Nine months
ended
September 30
|
|
2020
|
2019
|
|
U.S. dollars in
thousands
|
CASH FLOWS FROM
OPERATING ACTIVITIES:
|
|
|
Net loss
|
$
(10,557)
|
$
(41,043)
|
Adjustments
required to reconcile net loss to net cash used in operating
activities:
|
|
|
Depreciation
|
911
|
643
|
Impairment of
long-lived asset
|
-
|
9,759
|
Exchange differences
on cash and cash equivalents
|
18
|
69
|
Change in right of use
asset
|
372
|
523
|
Change in lease
liabilities
|
(410)
|
(380)
|
Gains on marketable
securities
|
(2)
|
(10)
|
Share-based
compensation
|
1,192
|
2,748
|
Changes in operating
assets and liabilities:
|
|
|
Decrease in prepaid
expenses and other receivables
|
3,074
|
483
|
Increase in deferred
tax assets
|
-
|
(223)
|
Increase (decrease) in
accounts payable and accruals
|
(3,806)
|
3,268
|
Increase in other
liabilities
|
347
|
245
|
Net cash used in
operating activities
|
(8,861)
|
(23,918)
|
CASH FLOWS FROM
INVESTING ACTIVITIES:
|
|
|
Purchase of property
and equipment
|
(16)
|
(791)
|
Investment in other
assets
|
-
|
(2,315)
|
Proceeds from disposal
of marketable securities, net
|
772
|
576
|
Net cash provided by
(used in) investing activities
|
756
|
(2,530)
|
CASH FLOWS FROM
FINANCING ACTIVITIES:
|
|
|
Proceeds from issuance
of ordinary shares, net of issuance costs
|
421
|
1,969
|
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 issuance
of ordinary shares and pre-funded warrants, net of issuance
costs
|
4,599
|
-
|
Proceeds from exercise
of warrants
|
769
|
-
|
Proceeds from exercise
of options
|
-
|
268
|
Net cash provided by
financing activities
|
15,907
|
2,237
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
7,802
|
(24,211)
|
CASH AND CASH
EQUIVALENTS AT BEGINNING OF THE PERIOD
|
9,292
|
39,246
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(18)
|
(69)
|
CASH AND CASH
EQUIVALENTS AT END OF THE PERIOD
|
$
17,076
|
$
14,966
|
|
|
|
SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING ACTIVITIES:
|
|
|
Liability with respect
to property and equipment
|
$
-
|
$
123
|
Liability with respect
to other assets
|
$
-
|
$
549
|
|
|
|
SUPPLEMENTARY
DISCLOSURE OF CASH FLOW INFORMATION -
|
|
|
Taxes paid
|
$
9
|
$
50
|
Interest
received
|
$
32
|
$
315
|
View original
content:http://www.prnewswire.com/news-releases/intec-pharma-reports-third-quarter-2020-financial-results-and-provides-corporate-update-301166326.html
SOURCE Intec Pharma Ltd.