/EINPresswire.com/ -- JERUSALEM, ISRAEL -- (Marketwired) -- 03/14/16 -- Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: INTP), an Israeli clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, today announced its financial results for the year ended December 31, 2015 and provided a business update. Results are presented in New Israel Shekels (NIS) with a convenience translation to US Dollars ($) provided using the Bank of Israel exchange rate of NIS 3.902 to $1.00 at December 31, 2015.

Financial highlights for the year ended December 31, 2015 and for the fourth quarter of 2015

• Research and Development Expenses, net for the quarter ended December 31, 2015 were approximately NIS 7.9 million ($2 million), compared to NIS 3.3 million in the comparable quarter of 2014. Research and development expenses, net, for the year ended December 31, 2015 were approximately NIS 18.7 million ($4.8 million), compared to NIS 12.2 million for the year ended December 31, 2014. The increase in both periods resulted primarily from an increase in expenses related to preparation for our Phase III clinical trial for our lead product, the Accordion Pill Carbidopa/Levodopa, or AP-CDLD, for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, payroll and related expenses and other expenses associated with our Phase III clinical trial for AP-CDLD, which were partially offset by increases in research and development-related grants and participation in research and development expenses from the Office of the Chief Scientist of the Israeli Ministry of Economy received in 2015 compared to 2014.
  
  
• General and Administrative Expenses for the quarter ended December 31, 2015 were approximately NIS 3.4 million ($871,000), compared to NIS 2.4 million in the comparable quarter of 2014. General and administrative expenses for the year ended December 31, 2015 were approximately NIS 10.8 million ($2.8 million) compared to NIS 9.3 million for the year ended December 31, 2014. The increase in both periods resulted primarily due to an increase in professional services, payroll and related expenses and other expenses associated with being a public company in the United States since August 2015.
  
  
• Financial Income, net for the year ended December 31, 2015 was approximately NIS 1.6 million ($402,000) compared to approximately NIS 324,000 for the year ended December 31, 2014. The increase resulted primarily due from increase in foreign currency exchange, which was partially offset by a decrease in financial income from interest on cash equivalents and short term bank deposits.
  
  
• Loss and Comprehensive Loss for the year ended December 31, 2015 was NIS 27.9 million ($7.1 million) or NIS 3.58 ($0.92) per share, based on 7.8 million basic and diluted shares, compared with a loss and comprehensive loss of NIS 20.4 million or NIS 4.22 per share, based on 4.8 million basic and diluted shares, for the year ended December 31, 2014.
  
  
• Net Cash Used in Operating Activities for the year ended December 31, 2015 was approximately NIS 30.8 million ($7.9 million) compared to approximately NIS 17 million in the year ended December 31, 2014. This increase primarily resulted from an increase in our loss and comprehensive loss of approximately NIS 7.5 million and an increase in changes in operating asset and liability items of approximately NIS 6.3 million.
  
  
• Net Cash Used in Investment Activities for the year ended December 31, 2015 was approximately NIS 24.8 million ($6.4 million), compared to approximately NIS 9.7 million of net cash provided by investment activities for the year ended December 31, 2014. The change primarily resulted from an increase in the purchase of property and equipment in the amount of approximately NIS 5.4 million and from investment in a short-term bank deposit in the amount of approximately NIS 19.4 million.
  
  
• Net Cash Provided by Financing Activities for the year ended December 31, 2015 was approximately NIS 124.1 million ($31.8 million) compared to approximately NIS 17.2 million for the year ended December 31, 2014. The positive cash flow from financing activities for the year ended December 31, 2015 was primarily due to proceeds from our initial public offering in the United States in the amount of approximately NIS 116.8 million.
  
  
• Cash, cash equivalents, short term bank deposits and financial assets at fair value as of December 31, 2015 were approximately NIS 119.7 million (approximately $30.7 million) as compared to approximately NIS 30.1 million as of December 31, 2014.
  

Zeev Weiss, CEO of Intec Pharma, said:

"2015 was an exciting year for Intec Pharma. During the year we addressed a number of very important milestones related to our platform technology, the Accordion Pill, as well as to our leading product candidate, AP-CDLD.

With respect to AP-CDLD, in May 2015 we agreed with the FDA on the remaining clinical development program for AP-CDLD for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, including the main principles of the single required pivotal Phase III clinical trial in advanced Parkinson's disease patients, under the 505(b) (2) regulatory pathway. In December 2015, we received a U.S. centralized IRB approval to initiate a Phase III clinical trial of AP-CDLD.

With respect to the Accordion Pill technology, we significantly enhanced the manufacturing capabilities of Accordion Pills by completing the installation of a fully automated assembly line in September 2015. We have also expanded the IP protection of our technology with the grant of several important patents. In 2015, we also entered into an exciting collaboration agreement with Biogen and, in addition, we initiated a Phase I clinical trial with our third pipeline product, which is being developed for the prevention and treatment of gastroduodenal and small bowel NSAID induced ulcers.

In addition to the very important clinical, development and regulatory milestones that we achieved in 2015, this year was exciting for Intec Pharma, as we became a public company traded on NASDAQ after we successfully completed our US IPO, raising net proceeds of approximately $30 million.

We look forward to continuing the achievement of major milestones in 2016."

Recent highlights

• On March 10, 2016, we announced that we completed a Phase I clinical trial of our third pipeline product, which is being developed for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug (NSAID) induced ulcers and is based on a new Accordion Pill formulation with an existing drug. The Pharmacokinetics (PK) results demonstrated in this Phase I trial were within the well-defined safety levels of the drug, which enable us to proceed with further development of the Accordion Pill with the existing drug.
• On December 23, 2015, the European Patent Office (EPO) granted a European patent on our European Patent Application for a "Zaleplon gastroretentive drug delivery system." The patent, number EP 237883, protects one of our product candidates, Accordion Pill Zaleplon, which is being developed for the indication of treatment of insomnia, including sleep induction and the improvement of sleep maintenance. The patent is currently scheduled to remain in force until October 19, 2029.
• On December 14, 2015, we announced that we received a US centralized institutional review board (IRB) approval to initiate our Phase III clinical trial for our lead product, AP-CDLD for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients. Approximately 460 patients will be enrolled in this single pivotal Phase III study in advanced Parkinson's disease patients. The total treatment period for each patient will be 25 weeks. The primary efficacy endpoint will be a change from baseline to termination of treatment in the percent of daily off time during waking hours.
• On November 4, 2015, the European Patent Office (EPO) be granted our European Patent Application for a "Method and Apparatus for Forming Delivery Devices for Oral Intake of an Agent". The patent, number EP 1981465, protects a method of producing our Accordion Pill platform, and the Accordion Pill produced thereby. The platform may be made from any suitable substances, and is intended for oral delivery of any pharmaceutically active agent of interest. The patent is currently scheduled to remain in force until January 18, 2027.
• On October 12, 2015, we announced topline results of a Food Effect PK study of AP-CDLD 50/500mg for the treatment of Parkinson's disease symptoms. The results demonstrated that plasma concentrations of carbidopa and levodopa were similar, with no statistically significant differences in all PK parameters measured, when AP-CDLD was taken with various food compositions. This suggests that the treatment with AP-CDLD, intended to be taken b.i.d (two times a day) or t.i.d (three times a day) with food, is independent of the food content.
• On August 9, 2015, we closed an underwritten public offering in the U.S. of 5,025,000 ordinary shares at a price to the public of $6.00 per share. We received proceeds from the public offering of approximately $26.5 million, net of commissions to the underwriters and offering expenses. On September 17, 2015, the underwriters partially exercised their overallotment option and purchased an additional 638,750 ordinary shares at a price to the public of $6 per share. We received proceeds of approximately $3.48 million related to the overallotment exercise, net of commissions to the underwriters and offering expenses, bringing the total net proceeds to us from the initial public offering to approximately $30 million. Maxim Group LLC and Roth Capital Partners acted as joint book-running managers for the offering.
  

                             INTEC PHARMA LTD.
                      STATEMENTS OF FINANCIAL POSITION

                                                                Convenience
                                                                translation
                                           December 31           into USD
                                   --------------------------  ------------
                                                               December 31,
                                       2014          2015          2015
                                   ------------  ------------  ------------
                                        NIS in thousands       In thousands
                                   --------------------------  ------------
              Assets
CURRENT ASSETS:
  Cash and cash equivalents              22,287        92,277        23,649
  Short-term bank deposits                             19,510         5,000
  Financial assets at fair value
   through profit or loss                 7,820         7,897         2,024
  Restricted bank deposits                  292           240            62
  Other receivables                       1,120         9,211         2,361
                                   ------------  ------------  ------------
                                         31,519       129,135        33,096
                                   ------------  ------------  ------------
NON-CURRENT ASSETS -
  Property and equipment                 17,101        15,906         4,076
                                   ------------  ------------  ------------
TOTAL ASSETS                             48,620       145,041        37,172
                                   ============  ============  ============

      Liabilities and equity
CURRENT LIABILITIES -
  Accounts payable and accruals:
    Trade                                   716         2,394           614
    Other                                 6,503         2,731           701
                                   ------------  ------------  ------------
                                          7,219         5,125         1,315
                                   ------------  ------------  ------------
NON-CURRENT LIABILITIES -
  Derivative financial instruments        4,528         1,277           327
                                   ------------  ------------  ------------
COMMITMENTS AND CONTINGENT
 LIABILITIES
                                   ------------  ------------  ------------
TOTAL LIABILITIES                        11,747         6,402         1,642
                                   ------------  ------------  ------------

EQUITY:
  Ordinary shares                         2,701         2,701           692
  Share premium                         198,566       328,985        84,312
  Warrants                                2,249             -             -
  Accumulated deficit                  (166,643)     (193,047)      (49,474)
                                   ------------  ------------  ------------
TOTAL EQUITY                             36,873       138,639        35,530
                                   ------------  ------------  ------------
TOTAL LIABILITIES AND EQUITY             48,620       145,041        37,172
                                   ============  ============  ============


                      STATEMENT OF COMPREHENSIVE LOSS


                                                                Convenience
                                                                translation
                              Year ended December 31             into USD
                     ----------------------------------------  ------------
                                                               December 31,
                         2013          2014          2015          2015
                     ------------  ------------  ------------  ------------
                                 NIS in thousands              In thousands
                     ----------------------------------------  ------------
RESEARCH AND
 DEVELOPMENT
 EXPENSES                 (17,410)      (17,740)      (29,257)       (7,498)
LESS- PARTICIPATION
 IN RESEARCH AND
 DEVELOPMENT
 EXPENSES                   8,393         5,544        10,556         2,705
                     ------------  ------------  ------------  ------------
RESEARCH AND
 DEVELOPMENT
 EXPENSES, net             (9,017)      (12,196)      (18,701)       (4,793)
GENERAL AND
 ADMINISTRATIVE
 EXPENSES                  (9,633)       (9,332)      (10,828)       (2,775)
OTHER GAINS, net              474           836            76            19
                     ------------  ------------  ------------  ------------
OPERATING LOSS            (18,176)      (20,692)      (29,453)       (7,549)
FINANCIAL INCOME              434         1,136         2,458           630
FINANCIAL EXPENSES           (648)         (812)         (889)         (228)
                     ------------  ------------  ------------  ------------
FINANCIAL INCOME
 (EXPENSES), net             (214)          324         1,569           402
                     ------------  ------------  ------------  ------------
LOSS AND
 COMPREHENSIVE LOSS       (18,390)      (20,368)      (27,884)       (7,147)
                     ============  ============  ============  ============
                                        NIS                         USD
                     ----------------------------------------  ------------
BASIC AND DILUTED
 LOSS PER ORDINARY
 SHARE                      (4.25)        (4.22)        (3.58)        (0.92)
                     ============  ============  ============  ============


                          STATEMENTS OF CASH FLOWS

                                                                Convenience
                                                                translation
                              Year ended December 31             into USD
                     ----------------------------------------  ------------
                                                               December 31,
                         2013          2014          2015          2015
                     ------------  ------------  ------------  ------------
                                 NIS in thousands              In thousands
                     ----------------------------------------  ------------
CASH FLOWS FROM
 OPERATING
 ACTIVITIES:
Loss for the year         (18,390)      (20,368)      (27,884)       (7,147)
  Adjustments to
   reconcile loss
   and comprehensive
   loss to net cash
   provided from
   operations:
    Depreciation            2,176         2,092         2,898           743
    Exchange
     differences on
     restricted
     deposits                  (6)           (1)            3             *
    Changes in the
     fair value of
     derivative
     financial
     instruments              (32)          729           829           212
    Exchange
     differences on
     cash and cash
     equivalents              223          (535)       (1,478)         (379)
    Exchange
     differences on
     short-term bank
     deposit                                              (85)          (22)
    Losses (gains)
     on financial
     assets at fair
     value through
     profit or loss          (474)           51           (76)          (19)
    Share-based
     compensation to
     investors                 88             -             -             -
    Share-based
     compensation to
     employees and
     service
     providers              1,829         1,207         1,480           379
  Changes in
   operating asset
   and liability
   items:
    Decrease
     (increase) in
     other
     receivables              871         1,463        (8,091)       (2,073)
    Increase
     (decrease) in
     accounts
     payable and
     accruals               1,497        (1,635)        1,608           413
                     ------------  ------------  ------------  ------------
  Net cash used in
   operating
   activities             (12,218)      (16,997)      (30,796)       (7,893)
                     ------------  ------------  ------------  ------------
CASH FLOWS FROM
 INVESTING
 ACTIVITIES:
  Purchase of
   property and
   equipment               (5,376)         (271)       (5,405)       (1,385)
  Investments in
   short-term
   deposits                     -             -       (19,425)       (4,978)
  Proceeds from
   disposal
   (purchase) of
   financial assets
   at fair value
   through profit or
   loss, net               (5,955)       10,016            (1)            *
  Changes in
   restricted bank
   deposits, net               76           (31)           49            12
                     ------------  ------------  ------------  ------------
  Net cash provided
   by (used in)
   investing
   activities             (11,255)        9,714       (24,782)       (6,351)
CASH FLOWS FROM
 FINANCING
 ACTIVITIES:
  Issuance of shares
   through public
   offering, net of
   issuance costs               -             -       116,780        29,928
  Exercise of
   warrants (series
   7)                           -             -         7,310         1,874
  Exercise of
   warrants (series
   3)                         251             -             -             -
  Exercise of
   options by
   employees and
   service providers          548           579             *             *
  Issuance of shares
   and warrants as
   part of an
   investment
   agreement, net of
   issuance costs          17,692             -             -             -
  Issuance of shares
   as part of an
   addendum to the
   investment
   agreement                    -           101             -             -
  Issuance of shares
   and warrants, net
   of issuance costs       15,015        16,592             -             -
                     ------------  ------------  ------------  ------------
  Net cash provided
   by financing
   activities              33,506        17,272       124,090        31,802
                     ------------  ------------  ------------  ------------
INCREASE IN CASH AND
 CASH EQUIVALENTS          10,033         9,989        68,512        17,558
CASH AND CASH
 EQUIVALENTS -
 BEGINNING OF YEAR          1,953        11,763        22,287         5,712
EXCHANGE DIFFERENCES
 ON CASH AND CASH
 EQUIVALENTS                 (223)          535         1,478           379
                     ------------  ------------  ------------  ------------
CASH AND CASH
 EQUIVALENTS - END
 OF YEAR                   11,763        22,287        92,277        23,649
                     ============  ============  ============  ============

  Information
   regarding
   investment and
   financing
   activities not
   involving cash
   flows:
    Liability with
     respect to
     property
     purchase order                       3,931
                                   ============
    Settlement of
     liability in
     respect to
     derivative
     financial
     instrument to
     equity                               6,499         4,080         1,046
                                   ============  ============  ============

  Supplementary
   information to
   the statement of
   cash flows -
    Interest
     received                 402           617           171            44
                     ============  ============  ============  ============

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 currently includes three product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CDLD, is being developed for the indication of treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, Accordion Pill Zaleplon, or AP-ZP, is being developed for the indication of treatment of insomnia, including sleep induction and the improvement of sleep maintenance and an Accordion Pill that is being developed for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug induced ulcers.

Forward Looking Statements
This press release contains forward-looking statements about the Company's 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 the company undertakes 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 the company's control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, and include the following: the company's ability to develop and commercialize its product candidates and obtain additional financing necessary therefor; the length, cost and uncertain results of the company's clinical trials; the availability of reimbursement from government authorities and health insurance companies for the company's products; the impact of product liability lawsuits; and the influence of extensive and costly government regulation.

Contact

Zeev Weiss
Chief Executive Officer
(+972) (2) 586-4657
Zeev@intecpharma.com

PCG Advisory
Investors:
Vivian Cervantes
Managing Director
Phone (+1) 212 554-5482

Media
Sean Leous
Managing Director
Phone (+1) 646 863-8998

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