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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K/A
(Amendment No. 1)
(Mark
One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the fiscal year ended December 31, 2020
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
FOR
THE TRANSITION PERIOD FROM TO
Commission
File Number 001-37521
INTEC
PHARMA LTD.
(Exact
name of Registrant as specified in its Charter)
Israel |
|
Not
Applicable |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
12
Hartom Street
Har
Hotzvim, Jerusalem |
|
9777512 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: +972-2-586-4657
Securities
registered pursuant to Section 12(b) of the Act:
Ordinary
Shares, no par value |
|
NTEC |
|
The
Nasdaq Capital Market |
(Title
of each class) |
|
Trading
Symbol(s) |
|
(Name
of each exchange on which registered) |
Securities
registered pursuant to Section 12(g) of the Act:
None
Indicate
by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ No
☒
Indicate
by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. 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 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, 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, smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
Emerging
growth company |
☐ |
|
|
If
an emerging growth company, 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 whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. ☐
Indicate
by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
The
aggregate market value of the ordinary shares held by non-affiliates of the Registrant, based on the closing price of the ordinary
shares on the Nasdaq Capital Market on June 30, 2020, was $19,549,537.
The
number of shares of Registrant’s ordinary shares outstanding as of March 12, 2021: 4,502,578.
DOCUMENTS
INCORPORATED BY REFERENCE
None.
EXPLANATORY NOTE
This Amendment
to the Annual Report on Form 10-K (the “Amendment”) of Intec Pharma Ltd (the “Company”) amends the Company’s
Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission on
March 16, 2021 (the “Original Report”). The sole purpose of this Amendment is to refile Exhibit 23.1 that was originally
filed with the Original Report to correct an incorrect date.
This Amendment
speaks as of the original filing date, does not reflect events occurring after the filing of the Original Report and does not
modify or update those disclosures that may be affected by subsequent events, and no other changes are being made to any
other disclosure contained in the Original Report.
This Amendment
is an exhibit-only filing, and except for the changes to Exhibit 23.1 described above, this Amendment does not
otherwise update any exhibits as originally filed or previously amended. In addition, as required by Rule 12b-15 under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), new certifications by the Company’s principal executive
officer and principal financial officer are filed herewith as exhibits to this Amendment pursuant to Rule 13a-14(a) of the Exchange
Act.
Exhibit Index
Exhibit
No. |
|
Exhibit
Description |
2.1 |
|
Agreement
and Plan of Merger and Reorganization, dated as of March 15, 2021, by and among Intec Pharma Ltd., Intec Parent, Inc., Dillon
Merger Sub Inc, Domestication Merger Sub, Ltd., and Decoy Biosystems, Inc. (incorporated herein by reference to Exhibit 2.1
to the Company’s Report on Form 8-K filed with the SEC on March 15, 2021)++ |
|
|
|
3.1 |
|
Certificate
of Incorporation of Orly Guy Ltd., dated October 23, 2000 (incorporated herein by reference to Exhibit 3.1 to the Company’s
Registration Statement on Form F-1 filed with the SEC on June 9, 2015) |
|
|
|
3.2 |
|
Certificate
of Name Change of Orly Guy Ltd. to Intec Pharmaceutical (2000) Ltd., dated February 7, 2001 (incorporated herein by reference
to Exhibit 3.2 to the Company’s Registration Statement on Form F-1 filed with the SEC on June 9, 2015) |
|
|
|
3.3 |
|
Certificate
of Name Change of Intec Pharmaceutical (2000) Ltd. to Intec Pharma Ltd., dated March 15, 2004 (incorporated herein by reference
to Exhibit 3.3 to the Company’s Registration Statement on Form F-1 filed with the SEC on June 9, 2015) |
|
|
|
3.4 |
|
Articles
of Association of Intec Pharma Ltd., as amended (incorporated herein by reference to Exhibit 3.1 to the Company’s Report
on Form 8-K filed with the SEC on October 29, 2020) |
|
|
|
4.1 |
|
Specimen
share certificate (incorporated herein by reference to Exhibit 2.1 to the Company’s Annual Report on Form 20-F filed
with the SEC on March 9, 2018) |
|
|
|
4.2 |
|
Form
of Warrant (incorporated herein by reference to Exhibit 4.1 to the Company’s Report on Form 8-K filed with the SEC on
February 3, 2020) |
|
|
|
4.3 |
|
Form
of Warrant (incorporated herein by reference to Exhibit 10.2 to the Company’s Report on Form 8-K filed with the SEC
on May 6, 2020) |
|
|
|
4.4 |
|
Description
of Securities Registered under Section 12 (incorporated herein by reference to Exhibit 4.4 to the Company’s Annual
Report on Form 10-K filed with the SEC on March 13, 2020) |
|
|
|
10.1† |
|
Joint
Venture for R&D, dated June 1, 2000, by and between Yissum Research Development Company of the Hebrew University of Jerusalem
and Intec Pharmaceutical Partnership Ltd. (incorporated herein by reference to Exhibit 10.1 to the Company’s Registration
Statement on Form F-1 filed with the SEC on June 9, 2015) |
|
|
|
10.2† |
|
Notice
of Extension Letter, dated October 5, 2004, from Intec Pharma Ltd. to Yissum Research Development Company of the Hebrew University
of Jerusalem (incorporated herein by reference to Exhibit 10.2 to the Company’s Registration Statement on Form F-1 filed
with the SEC on June 9, 2015) |
|
|
|
10.3 |
|
Amendment,
dated July 13, 2005, by and between Yissum Research Development Company of the Hebrew University of Jerusalem and Intec Pharma
Ltd., to the Joint Venture for R&D Agreement dated June 1, 2000 (incorporated herein by reference to Exhibit 10.3 to the
Company’s Registration Statement on Form F-1 filed with the SEC on June 9, 2015) |
|
|
|
10.4 |
|
Research
Agreement, dated January 15, 2008, by and between Yissum Research Development Company of the Hebrew University of Jerusalem
and Intec Pharma Ltd. (incorporated herein by reference to Exhibit 10.4 to the Company’s Registration Statement on Form
F-1 filed with the SEC on June 9, 2015) |
|
|
|
10.5 |
|
Compensation
Policy for Intec Pharma Ltd.’s Directors and Officers, as amended (incorporated herein by reference to Exhibit 10.1
to the Company’s Report on Form 8-K filed with the SEC on July 17, 2020) |
|
|
|
10.6+ |
|
Intec
Pharma Ltd. 2005 Share Option Plan (incorporated herein by reference to Exhibit 10.6 to the Company’s Registration Statement
on Form F-1 filed with the SEC on June 9, 2015) |
10.7+ |
|
Intec
Pharma Ltd. 2015 Equity Incentive Plan (incorporated herein by reference to Exhibit 99.2 to the Company’s Registration
Statement on Form S-8 filed with the SEC on February 25, 2016) |
|
|
|
10.8 |
|
Form
of Intec Pharma Ltd. Grant Letter – Section 102 (incorporated herein by reference to Exhibit 10.8 to the Company’s
Annual Report on Form 10-K filed with the SEC on March 13, 2020) |
|
|
|
10.9 |
|
Form
of Intec Pharma Ltd. 2015 Equity Incentive Plan Notice Of Non-Qualified Stock Option Award (incorporated herein by reference
to Exhibit 10.9 to the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2020) |
|
|
|
10.10 |
|
Unprotected
Lease Agreement between Intec Pharma Ltd. and R.M.P.A. Assets Ltd., dated June 2, 2003, together with supplements thereto
dated as of April 21, 2004, January 1, 2006, December 15, 2009, January 18, 2011, October 28, 2015 and December 31, 2017 (incorporated
herein by reference to Exhibit 4.8 to the Company’s Annual Report on Form 20-F filed with the SEC on March 9, 2018) |
|
|
|
10.11+ |
|
Employment
Agreement, dated December 11, 2017, between Intec Pharma Inc., Intec Pharma Ltd. and Jeffrey A. Meckler (incorporated herein
by reference to Exhibit 4.11 to the Company’s Annual Report on Form 20-F filed with the SEC on March 9, 2018) |
|
|
|
10.12+ |
|
Employment
Agreement, dated January 15, 2006, between Intec Pharma Ltd. and Nadav Navon, as amended on May 29, 2011, March 2012, October
21, 2013 and January 1, 2018 (incorporated herein by reference to Exhibit 4.12 to the Company’s Annual Report on Form
20-F filed with the SEC on March 9, 2018) |
|
|
|
10.13+ |
|
Employment
Agreement, dated February 23, 2010, between Intec Pharma Ltd. and Nir Sassi, as amended on March 28, 2012, October 21, 2013
and January 1, 2018 (incorporated herein by reference to Exhibit 4.13 to the Company’s Annual Report on Form 20-F filed
with the SEC on March 9, 2018) |
|
|
|
10.14 |
|
Form
of Indemnification Agreement (incorporated herein by reference to Exhibit 10.20 to Amendment No. 2 to the Company’s
Registration Statement on Form F-1 filed with the SEC on July 28, 2015) |
|
|
|
10.15 |
|
Form
of Exemption from Liability (incorporated herein by reference to Exhibit 10.21 to Amendment No. 2 to the Company’s Registration
Statement on Form F-1 filed with the SEC on July 28, 2015) |
|
|
|
10.16† |
|
Amendment,
dated March 12, 2015, by and between Yissum Research Development Company of the Hebrew University of Jerusalem and Intec Pharma
Ltd., to the Joint Venture of R&D Agreement dated June 1, 2000 (incorporated herein by reference to Exhibit 10.17 to Amendment
No. 1 to the Company’s Registration Statement on Form F-1 filed with the SEC on July 16, 2015) |
|
|
|
10.17+ |
|
Employment
Agreement dated October 23, 2017 between Intec Pharma, Inc. and Walt Addison Linscott, Esq. (incorporated herein by reference
to Exhibit 10.24 to the Company’s Annual Report on Form 10-K filed with the SEC on February 27, 2019) |
|
|
|
10.18† |
|
Process
Development Agreement dated as of December 17, 2018 by and between Intec Pharma Ltd. and LTS LOHMANN Therapie-Systeme AG (incorporated
herein by reference to Exhibit 10.26 to the Company’s Annual Report on Form 10-K filed with the SEC on February 27,
2019) |
|
|
|
10.19 |
|
Ordinary
Shares Purchase Agreement, dated December 2, 2019 between Intec Pharma Ltd. and Aspire Capital Fund, LLC (incorporated herein
by reference to Exhibit 10.1 to the Company’s Report on Form 8-K filed with the SEC on December 3, 2019) |
|
|
|
10.20 |
|
Registration
Rights Agreement, dated December 2, 2019, between Intec Pharma Ltd. and Aspire Capital Fund, LLC (incorporated herein by reference
to Exhibit 10.2 to the Company’s Report on Form 8-K filed with the SEC on December 3, 2019) |
10.21 |
|
Underwriting
Agreement, dated January 30, 2020, by and between the Company and H.C. Wainwright & Co., LLC (incorporated herein by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on February 3, 2020) |
|
|
|
10.22 |
|
Securities
Purchase Agreement, dated May 4, 2020, between Intec Pharma Ltd. and the Purchasers (incorporated herein by reference to Exhibit
10.1 to the Company’s Current Report on Form 8-K filed with the SEC on May 4, 2020) |
|
|
|
10.23 |
|
Securities
Purchase Agreement, dated August 7, 2020, between Intec Pharma Ltd. and Aspire Capital Fund, LLC (incorporated herein by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed with the SEC on August 10, 2020) |
|
|
|
10.24 |
|
Form
of Decoy Stockholder Support Agreement (incorporated herein by reference to Exhibit 10.1 to the Company’s Report on
Form 8-K filed with the SEC on March 15, 2021) |
|
|
|
10.25 |
|
Form
of Intec Shareholder Support Agreement (incorporated herein by reference to Exhibit 10.2 to the Company’s Report on
Form 8-K filed with the SEC on March 15, 2021) |
|
|
|
10.26 |
|
Form
of Lock-Up Agreement (incorporated herein by reference to Exhibit 10.3 to the Company’s Report on Form 8-K filed with
the SEC on March 15, 2021) |
|
|
|
21.1** |
|
List of Subsidiaries |
|
|
|
23.1* |
|
Consent
of Kesselman & Kesselman, Certified Public Accountant (Isr.), independent registered public accounting firm, a member
of PricewaterhouseCoopers International Limited |
|
|
|
24.1 |
|
Power of Attorney (incorporated herein by reference to the signature page of the Original Report) |
|
|
|
31.1* |
|
Certification
of Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a), promulgated under the Securities Exchange Act
of 1934, as amended |
|
|
|
31.2* |
|
Certification
of Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a), promulgated under the Securities Exchange Act
of 1934, as amended |
|
|
|
32.1# |
|
Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2# |
|
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
101.INS** |
|
XBRL Instance Document |
|
|
|
101.SCH** |
|
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL** |
|
XBRL Taxonomy Extension Calculation
Linkbase Document |
|
|
|
101.DEF** |
|
XBRL Taxonomy Extension Definition
Linkbase Document |
|
|
|
101.LAB** |
|
XBRL Taxonomy
Extension Labels Linkbase Document |
|
|
|
101.PRE** |
|
XBRL Taxonomy
Extension Presentation Linkbase Document |
* |
Filed herewith |
# |
Previously furnished |
** |
Previously filed |
† |
Certain portions of this agreement
have been omitted under a confidential treatment order pursuant to Rule 406 of the Securities Act of 1933, as amended, and
Rule 24b-2 of the Securities Exchange Act of 1934, as amended, and filed separately with the SEC. |
+ |
Indicates management contract
or compensatory plan.
|
++ |
The schedules to the agreement have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any
omitted schedule will be furnished to the SEC upon request. |
Certain agreements
filed as exhibits to this Annual Report contain representations and warranties that the parties thereto made to each other. These
representations and warranties have been made solely for the benefit of the other parties to such agreements and may have been
qualified by certain information that has been disclosed to the other parties to such agreements and that may not be reflected
in such agreements. In addition, these representations and warranties may be intended as a way of allocating risks among parties
if the statements contained therein prove to be incorrect, rather than as actual statements of fact. Accordingly, there can be
no reliance on any such representations and warranties as characterizations of the actual state of facts. Moreover, information
concerning the subject matter of any such representations and warranties may have changed since the date of such agreements.
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed
on its behalf by the undersigned, thereunto duly authorized.
|
Intec
Pharma Ltd. |
|
|
|
Date:
March 17, 2021 |
By: |
/s/
Jeffrey A. Meckler |
|
|
Jeffrey A.
Meckler |
|
|
Chief Executive Officer and Vice Chairman |
Name |
|
Title |
|
Date |
|
|
|
|
|
/s/
Jeffrey A. Meckler |
|
Chief
Executive Officer and Vice Chairman |
|
March
17, 2021 |
Jeffrey A. Meckler |
|
(Principal Executive
Officer) |
|
|
|
|
|
|
|
/s/
Nir Sassi |
|
Chief
Financial Officer |
|
March
17, 2021 |
Nir Sassi |
|
(Principal Financial
and Accounting Officer) |
|
|
|
|
|
|
|
* |
|
Chairman
of the Board of Directors |
|
March
17, 2021 |
Dr. John Kozarich |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
March
17, 2021 |
Hila Karah |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
March
17, 2021 |
Anthony J. Maddaluna |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
March
17, 2021 |
Dr. Roger J.
Pomerantz |
|
|
|
|
|
|
|
|
|
* |
|
Director |
|
March
17, 2021 |
William B. Hayes |
|
|
|
|
*By |
/s/
Jeffrey A. Meckler |
|
|
Jeffrey A. Meckler |
|
|
Attorney-in-fact |
|
6