Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934




Download 4.48 Mb.
NameRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934
page1/89
A typeDocumentation
  1   2   3   4   5   6   7   8   9   ...   89



 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

 

FORM 20-F

 



REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

Or



ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2017 

Or



TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Or



SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission File No. 001-37521

 

 

 

INTEC PHARMA LTD.

(Exact name of Registrant as specified in its charter)

 

N/A

(Translation of Registrant’s name into English)

 

State of Israel

 (Jurisdiction of incorporation or organization)

 

12 Hartom Street, Har Hotzvim, Jerusalem 9777512, Israel

 (Address of principal executive offices)

 

Jeffrey A. Meckler

Chief Executive Officer

12 Hartom Street, Har Hotzvim

Jerusalem 9777512, Israel

Tel: (+972) (2) 586-4657

(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered 

Ordinary shares, no par value

 

Nasdaq Capital Market

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: 26,075,770

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.

Yes ☐ No ☒

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. Yes ☐   No ☒

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such a shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒  No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer   ☐

Accelerated filer ☐

Non-accelerated filer ☐

 

 

Emerging growth company ☒

  

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

U.S. GAAP ☐

International Financial Reporting Standards

as issued by the International Accounting Standards Board ☒

Other ☐

  

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the Registrant has elected to follow: Item 17 ☐ Item 18 ☐

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

 
 

 

TABLE OF CONTENTS

 

PART I

6

ITEM 1. Identity of Directors, Senior Management and Advisers

6

ITEM 2. Offer Statistics and Expected Timetable

6

ITEM 3. Key Information

6

ITEM 4. Information on the Company

47

ITEM 4A. Unresolved Staff Comments

75

ITEM 5. Operating and Financial Review and Prospects

75

ITEM 6. Directors, Senior Management and Employees

84

ITEM 7. Major Shareholders and Related Party Transactions

108

ITEM 8. Financial Information

110

ITEM 9. The Offer and Listing

110

ITEM 10. Additional Information

112

ITEM 11. Quantitative and Qualitative Disclosures About Market Risk

133

ITEM 12. Description of Securities Other Than Equity Securities

134

 

 

PART II

135

ITEM 13. Defaults, Dividend Arrearages and Delinquencies

135

ITEM 14. Material Modifications to the Rights of Security Holders and Use of Proceeds

135

ITEM 15. Controls and Procedures

135

ITEM 16. [RESERVED]

136

ITEM 16A. Audit Committee Financial Expert

136

ITEM 16B. Code of Ethics

136

ITEM 16C. Principal Accountant Fees and Services

137

ITEM 16D. Exemptions from the Listing Standards for Audit Committees

137

ITEM 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers

137

ITEM 16F. Change in Registrant’s Certifying Accountant

137

ITEM 16G. Corporate Governance

137

ITEM 16H. Mine Safety Disclosure

138

 

 

PART III

139

ITEM 17. Financial Statements

139

ITEM 18. Financial Statements

139

ITEM 19. Exhibits

140

 


 

 

ABOUT THIS ANNUAL REPORT

 

All references to “we,” “us,” “our,” “Intec”, “the Company” and “our Company”, in this Annual Report on Form 20-F, or our annual report, are to Intec Pharma Ltd. and its U.S. subsidiary Intec Pharma Inc., unless the context otherwise requires. All references to “ordinary shares” and “share capital” refer to ordinary shares and share capital of Intec. All references to “Israel” are to the State of Israel. Our consolidated financial statements are prepared and presented in accordance with International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our historical results do not necessarily indicate our expected results for any future periods. Any discrepancies in any table between totals and sums of the amounts listed are due to rounding. Unless otherwise indicated, or the context otherwise requires, references in this annual report to financial and operational data for a particular year refer to the fiscal year of our Company ended December 31 of that year.

 

In this annual report, “NIS” means New Israeli Shekel, and “$,” “US$” and “U.S. dollars” mean United States dollars.

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This annual report on Form 20-F contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies, plans and prospects. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should,” “anticipate,” “could,” “might,” “seek,” “target,” “will,” “project,” “forecast,” “continue” 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 may be included in, among other things, various filings made by us with the Securities and Exchange Commission, or the SEC, press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. 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 factors summarized below:

 

 



 

We are a clinical stage biopharmaceutical company with a history of operating losses, are not currently profitable, do not expect to become profitable in the near future and may never become profitable.

 

 



Our independent registered public accounting firm has expressed substantial doubt regarding our ability to continue as a going concern.

 

 



Because of our limited operating history, we may not be able to successfully operate our business or execute our business plan.

 

 



We face continuous technological change, and developments by competitors may render our products or technologies obsolete or non-competitive. If our new or existing product candidates are rendered obsolete or non-competitive, our marketing and sales will suffer and we may never be profitable.

 

 



We license our core technology on an exclusive basis from Yissum (Hebrew University), and we could lose our rights to this license if a dispute with Yissum arises or if we fail to comply with the financial and other terms of the license.

 

 



If we fail to adequately protect, enforce or secure rights to the patents which were licensed to us or any patents we may own in the future, the value of our intellectual property rights would diminish and our business and competitive position would suffer.

 


 

 

 



Our product candidates are at various stages of preclinical and clinical development and may never be commercialized.

 

 



We cannot be certain that the results of our potential Phase III clinical trials, even if all endpoints are met, will support regulatory approval of any of our product candidates for any indication.

 

 



Our product candidates are subject to extensive regulation and are at various stages of regulatory development and may never obtain regulatory approval.

 

 



We are subject to anti-kickback laws and regulations. Our failure to comply with these laws and regulations could have adverse consequences to us.

   

 



Potential political, economic and military instability in the State of Israel, where some of our senior management, our head executive office, research and development, and manufacturing facilities are located, may adversely affect our results of operations.

 

We believe these forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this annual report in greater detail under the heading “Risk Factors” and elsewhere in this annual report. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. 

 

All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly qualified in their entirety by the cautionary statements included in this annual report. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties.

 


 

 

EXPLANATORY NOTE

 

Market data and certain industry data and forecasts used throughout this annual report were obtained from market research databases, consultant surveys commissioned by us, publicly available information, reports of governmental agencies and industry publications and surveys. Industry surveys, publications, consultant surveys commissioned by us and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable. We have relied on certain data from third-party sources, including internal surveys, industry forecasts and market research, which we believe to be reliable based on our management’s knowledge of the industry. Statements as to our market position are based on the most currently available data. While we are not aware of any misstatements regarding the industry data presented in this annual report, our estimates involve risks and uncertainties and are subject to change based on various factors, including those discussed under the heading “Risk Factors” in this annual report. Notwithstanding the foregoing, we remain responsible for the accuracy and completeness of the historical information presented in this annual report, as of the date on the front cover of this annual report.

 


 

 

  1   2   3   4   5   6   7   8   9   ...   89

Share in:

Related:

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to Section 12(b) or 12(g) of the Securities Exchange Act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or 12(g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or 12(g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconX registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 icon[ ] registration statement pursuant to section 12(b) or (g) of the...

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconO Registration statement pursuant to Section 12(b) or 12(g) of the...

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or 12(g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or 12(g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconO registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconO registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or 12(g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934

Registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934 iconRegistration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934




manual




When copying material provide a link © 2017
contacts
manual-guide.com
search