EX-99.3 4 s110158_ex99-3.htm EXHIBIT 99.3

 

Exhibit 99.3

 

Management’s Discussion and Analysis of Financial Condition and Results of Operation

  

General

 

The following discussion and analysis provides information that we believe to be relevant to an assessment and understanding of our results of operations and financial condition for the periods described. This discussion should be read together with our condensed consolidated interim financial statements and the notes to the financial statements, which are included in this Report of Foreign Private Issuer on Form 6-K. This information should also be read in conjunction with the information contained in our Annual Report on Form 20-F for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 9, 2018, including the annual financial statements as of December 31, 2017 and their accompanying notes included therein.

 

This Report of Foreign Private Issuer on Form 6-K of Intec Pharma Ltd. 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 Report of Foreign Private Issuer on Form 6-K are made as of the date of this Report of Foreign Private Issuer on Form 6-K, 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.

 

All references to “we,” “us,” “our,” “Intec”, “the Company” and “our Company” in this Report of Foreign Private Issuer on Form 6-K are to Intec Pharma Ltd. and its U.S. subsidiary Intec Pharma Inc., unless the context otherwise requires.

 

Overview

 

We are a clinical stage biopharmaceutical company focused on developing drugs based on our proprietary Accordion Pill platform technology, which we refer to as the Accordion Pill. Our 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, or GR, and specific release mechanism. Our product pipeline currently includes several product candidates in various clinical trial stages. Our leading product candidate, Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, is being developed for the indication of treatment of Parkinson’s disease symptoms in advanced Parkinson’s disease patients.

 

We have successfully completed a Phase II clinical trial for AP-CD/LD for the treatment of Parkinson’s disease symptoms in advanced Parkinson’s disease patients and have agreed with the U.S. Food and Drug Administration, or the FDA, on the remaining clinical development program for AP-CD/LD 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. We have enrolled more than 350 patients to date in the ACCORDANCE study, the pivotal Phase III clinical trial for AP-CD/LD, and we currently expect to complete patient enrollment in the trial during the second half of 2018.

 

 

 

  

In our correspondence with the FDA, the FDA previously agreed that an acceptable regulatory pathway for AP-CD/LD would be to file a new drug application, or NDA, pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FDCA, which is a streamlined approval pathway that may accelerate the time to commercialize and decrease the costs of FDA approval for AP-CD/LD, as compared to those typically associated with a new chemical entity.

 

In addition, we have initiated a clinical development program for our Accordion Pill platform with the two primary cannabinoids contained in cannabis sativa, cannabidiol, or CBD, and 9-tetrahydrocannabinol, or THC, both individually and combined, which we refer to as AP-Cannabinoids. We are formulating and testing CBD and THC for the treatment of various indications, including low back pain, neuropathic pain and fibromyalgia. AP-Cannabinoids are designed to extend the absorption phase of CBD and THC, resulting in more consistent levels for an improved therapeutic effect, which may address several major drawbacks of current methods of treatments, such as short duration of effect, delayed onset, variability of exposure, variability of the administered dose and adverse events that correlate with peak levels.

 

In August 2017, we announced the results of a Phase I clinical trial that compared the safety, tolerability and pharmacokinetic (PK) of AP-CBD/THC with Sativex®. This Phase I trial was a single-center, single-dose, randomized, three-way crossover study in Israel to compare the safety, tolerability and PK of two formulations of AP-CBD/THC with Buccal Sativex® in 21 normal, healthy volunteers. The results showed that patients in the AP-CBD/THC arm demonstrated significant improvements in exposure to CBD (290% to 330%) and THC (25% to 50%) compared with Sativex®. The median time to peak concentration was 2-3 times longer than Sativex and absorption was significantly higher. Additionally, the formation of THC metabolites was meaningfully reduced, and the drug was found to be safe and well-tolerated with no serious adverse events reported. Sativex® is an oral buccal spray containing CBD and THC that is commercially available outside the United States. Following the Phase I clinical trial, we evaluated the program and decided as a next step to develop two new Accordion Pills containing only the individual cannabinoid components, namely CBD and THC. A Phase I PK study with AP-THC is planned to be initiated in the second half of 2018. We believe that exploring the individual components will provide additional indications to pursue.

 

In March 2018, we entered into a Term Sheet for Manufacturing Services with LTS Lohmann Therapie-Systeme AG, or LTS, for the manufacture of AP-CD/LD. Under the term sheet, LTS will exclusively manufacture and supply us with AP-CD/LD capsules using our proprietary Accordion Pill production technology in LTS’ manufacturing facility in Andernach, Germany upon the completion of assembly of the production line and subject to the execution and terms of a manufacturing and supply agreement to be negotiated and entered into between us and LTS.

 

Under the terms of the term sheet, we will bear the costs incurred by LTS to acquire the production equipment for AP-CD/LD; however, such amount will later be reimbursed to us by LTS in the form of a reduction in the purchase price of the product. The term sheet contains several termination rights which are expected to be included in a definitive manufacturing and supply agreement, including, among others, in the cases of breach by either party, as well as our right to terminate in the case of change of control of LTS or us, and in the event, we decide to halt the development of AP-CD/LD.

 

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Basis of Presentation

 

Our condensed consolidated interim financial statements as of March 31, 2018 and for the three months then ended, or the condensed consolidated interim financial statements, have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These condensed consolidated interim financial statements, which are unaudited, do not include all disclosures necessary for a complete statement of financial position, results of operations, and cash flow in conformity with International Financial Reporting Standards, or IFRS. The condensed consolidated interim financial statements should be read in conjunction with the annual financial statements as of December 31, 2017 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS as published by the International Accounting Standards Board, or IASB.

 

Results of Operations

 

Comparison of Three Months Ended March 31, 2018 and 2017

 

Research and Development Expenses, Net

 

Our research and development expenses, net, for the three-month period ended March 31, 2018 amounted to approximately $8.9 million, an increase of $5.0 million, or approximately 128%, compared to approximately $3.9 million in the comparable period in the preceding year. The increase was primarily due to an increase in expenses related to the progression of the ACCORDANCE study, our Phase III clinical trial for AP-CD/LD, expenses related to the establishment of the commercial scale production capabilities for AP-CD/LD and payroll and related expenses, mostly due to an increase in headcount. 

 

General and Administrative Expenses 

 

Our general and administrative expenses for the three-month period ended March 31, 2018 amounted to approximately $1.9 million, an increase of $0.9 million, or approximately 90%, compared to approximately $1.0 million in the comparable period in the preceding year. The increase was primarily due to the increase in share-based compensation to employees and payroll and related expenses primarily related to the hiring of management personnel in the United States and expenses related to investor relations activities.    

 

Financial Income, Net

 

For the three-month period ended March 31, 2018, we had financial income from interest on cash and cash equivalents in the amount of approximately $146,000 and foreign currency exchange income in the amount of approximately $57,000 offset by financial expenses from bank fees.

 

Loss and Comprehensive Loss

 

As a result of the foregoing, for the three-month period ended March 31, 2018, our loss and comprehensive loss was approximately $10.7 million, an increase of $6.0 million, or approximately 128%, compared to our loss and comprehensive loss for the three-month period ended March 31, 2017 of approximately $4.7 million. The increase was mainly due to an increase in research and development expenses, as detailed above.

 

Liquidity and Capital Resources  

 

Since our inception, we have funded our operations primarily through public and private offerings (in Israel and in the United States) of our equity securities, grants from governmental authorities and grants from other organizations such as the Michael J. Fox Foundation, as well as payments received under feasibility and related agreements that we have entered into with multinational pharmaceutical companies, pursuant to which we have historically been entitled to full coverage of our development costs with regard to the projects specified in those agreements. 

  

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As of March 31, 2018, we had cash and cash equivalents and financial assets at fair value through profit or loss of approximately $42.8 million. As of December 31, 2017, we had cash and cash equivalents and financial assets at fair value through profit or loss of approximately $55.2 million. 

 

Net cash used in operating activities was approximately $10.3 million for the three-month period ended March 31, 2018 compared with net cash used in operating activities of approximately $4.2 million for the three-month period ended March 31, 2017. This increase resulted primarily from an increase in our loss and comprehensive loss of approximately $6.0 million.

 

We had negative cash flow from investing activities of approximately $2.0 million for the three-month period ended March 31, 2018 compared to negative cash flow from investing activities of approximately $0.2 million for the three-month period ended March 31, 2017. This increase resulted primarily from an increase in purchase of property and equipment in the amount of approximately $1.7 million.

 

In April 2018, we completed an underwritten public offering of our ordinary shares on the Nasdaq Capital Market, pursuant to which we issued 6,750,000 ordinary shares at a price of $5.25 per share. On May 10, 2018, the underwriters partially exercised their over-allotment option and purchased 400,000 additional ordinary shares. The total net proceeds were approximately $34.9 million (net of underwriting discounts, commissions and other offering expenses in the amount of $2.6 million).

 

Current Outlook

 

We estimate that our cash resources as of the date of this Report of Foreign Private Issuer on Form 6-K will allow us to complete our Phase III clinical trial for AP-CD/LD. We believe however, that further fund raising will be required in order to complete the research and development of all of our product candidates, including the manufacturing activities of the AP-CD/LD in the foreseeable future. As a result, there is substantial doubt about our ability to continue as a going concern. We expect to satisfy our future cash needs through submissions of applications for grants from private funds, license agreements with third parties and capital raising from the public, private investors and institutional investors, such as through the public offering of ordinary shares that we completed in April 2018. We may also engage with a partner in order to share the costs associated with the development and manufacturing of our product candidates. For more information see note 1a(2) in our consolidated interim financial statements for the three months ended March 31, 2018.

 

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