Intec Pharma Reports 2016 Fourth Quarter and Full Year Financial Results

JERUSALEM, April 7, 2017 /PRNewswire/ -- Intec Pharma Ltd. (Nasdaq and TASE: NTEC), a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill™ platform technology, today reported financial results for the three and 12 months ended December 31, 2016.

Highlights of the fourth quarter of 2016 and recent weeks include:

• Initiated a Phase I clinical trial of AP-CBD/THC, the Company's Accordion Pill platform with the two primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC), which is being developed for various indications including low back neuropathic pain and fibromyalgia. The Company expects to have topline results from this trial in the third quarter of 2017;
• Raised approximately $10 million through a private placement that included participation by the Company's Chairman, Dr. John Kozarich, and two other directors;
• Announced a protocol amendment to the ACCORDANCE study, the Company's Phase III clinical trial of Accordion Pill Carbidopa/Levodopa (AP-CD/LD) for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients that reduced the sample size from 460 to 328 patients without altering the trial's objectives, endpoints or statistical powering;
• Entered into an agreement with the Michael J. Fox Foundation for Parkinson's Research to support patient recruitment and retention for the ACCORDANCE study; and
• Announced the granting of European and Chinese patents for an Accordion Pill containing certain drugs, including the combination Carbidopa and Levodopa. The patents are currently scheduled to remain in force until April 2029, and complement patents already granted in the U.S. and Israel.

Management Commentary

"Intec made very significant progress over the past several months with key clinical and corporate initiatives that we believe position us to achieve a number of important milestones throughout the balance of 2017. Patient recruitment into the ACCORDANCE study continues on pace and we currently expect to complete enrollment during the fourth quarter of 2017. In addition, we were very pleased to initiate the Phase I clinical trial of AP-CBD/THC, our first demonstration of the Accordion Pill platform for cannabinoid therapies, which we believe holds significant opportunities as a therapy for pain management," said Zeev Weiss, Chief Executive Officer of Intec Pharma. "Importantly, we strengthened our balance sheet to support these efforts with the $10 million private placement that we completed in March. We see great opportunities to continue building Intec throughout 2017 and look forward to advancing our vision to become a leader in Parkinson's disease treatment and in oral drug delivery with our Accordion Pill platform, which is under development to bring innovative new therapies to patients across various important indications, with significant unmet needs."

Financial Highlights for the Three and 12 Months Ended December 31, 2016

Research and development expenses, net, for the fourth quarter of 2016 were approximately $2.7 million, compared with approximately $2.1 million for the fourth quarter of 2015. Research and development expenses, net, for 2016 were approximately $10.7 million, compared with approximately $4.8 million for 2015. The increases in both periods resulted primarily from higher expenses related to the Company's Phase III clinical trial of its lead product, AP-CD/LD, and payroll and related expenses, partially offset by an increase in participation in research and development expenses from the Office of the Chief Scientist of the Ministry of Economy and Industry received in 2016 compared with 2015.

General and administrative expenses for the fourth quarter of 2016 were approximately $831,000 compared with approximately $869,000 for the fourth quarter of 2015. General and administrative expenses for 2016 were approximately $3.1 million compared with approximately $2.8 million for 2015. The increase for the year was primarily due to expenses associated with being a public company in the U.S. since August 2015.

Financial income, net, for 2016 was approximately $450,000, which included financial income from interest on cash equivalents and bank deposits of approximately $176,000, financial income from change in fair value of derivative financial instruments of approximately $230,000 and foreign currency exchange income of approximately $60,000, partially offset by financial expenses from bank fees of approximately $16,000. Financial income, net, for 2015 was approximately $404,000, which included financial income from interest on cash equivalents and bank deposits of approximately $44,000 and foreign currency exchange income of approximately $589,000, partially offset by financial expenses from change in fair value of derivative financial instruments of approximately $213,000 and financial expenses from bank fees of approximately $16,000.

Loss and comprehensive loss for 2016 was approximately $13.4 million, or $1.17 per share based on 11.4 million shares outstanding, compared with a loss and comprehensive loss for 2015 of approximately $7.8 million, or $0.92 per share based on 7.8 million shares outstanding. The loss and comprehensive loss for the fourth quarter of 2016 was approximately $3.6 million, or $0.32 per share based on 11.4 million shares outstanding, compared with a loss and comprehensive loss for the fourth quarter of 2015 of approximately $2.8 million, or $0.26 per share based on 11.4 million shares outstanding.

Net cash used in operating activities for 2016 was approximately $12.0 million compared with approximately $7.9 million for 2015, primarily due to an increase in net loss of approximately $6.2 million, partially offset by a decrease in changes in operating assets and liability items of approximately $2.1 million.

Net cash provided by investing activities for 2016 was approximately $4.7 million compared with approximately $6.4 million of net cash used in investing activities for 2015. The change resulted from the maturities of short-term deposits, net, in the amount of approximately $5.0 million that were invested in 2015, the decrease in purchase of property and equipment in the amount of approximately $900,000 and the disposal of financial assets at fair value through profit and loss, net in the amount of approximately $0.2 million.

Cash, cash equivalents and financial assets at fair value as of December 31, 2016 were approximately $18.2 million compared with approximately $30.7 million cash, cash equivalents, short-term bank deposits and financial assets at fair value as of December 31, 2015. In March 2017, the Company completed a private placement of 2,289,638 ordinary shares with various investors at a price of $4.40 per share, for gross proceeds of approximately $10 million.

The annual report on Form 20-F, containing audited financial statements for the year ended December 31, 2016, as filed with the Securities and Exchange Commission on April 7, 2017, is available through the Company's website (http://intecpharma.com). Shareholders may receive a hard copy of the annual report free of charge upon request to the Company. 

About Intec Pharma Ltd.

Intec Pharma Ltd. 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 four product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is being developed for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients; Accordion Pill Zaleplon, or AP-ZP, which is being developed for the treatment of insomnia, including sleep induction and the improvement of sleep maintenance; an Accordion Pill that is being developed for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug (NSAID)-induced ulcers; and AP-CBD/THC, an Accordion Pill with the two primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC), which is being developed for various indications including low back neuropathic pain and fibromyalgia.

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; including uncertainty regarding the Company's ability to enroll the required number of patients therein; the potential of adverse side effects, other safety risks, or legal prohibitions on the use of certain products in certain jurisdictions that could preclude the approval of the company's drug candidates; 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.

Contacts:

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

Anne Marie Fields
Senior Vice President
LHA
+1-212-838-3777
afields@lhai.com

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SOURCE Intec Pharma Ltd.