Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Evaluation of disclosure controls and procedures
Management, under the supervision and with the participation of our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of December 31, 2020. Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures as of December 31, 2020 were effective at the reasonable assurance level.
Management’s annual report on internal control over financial reporting .
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our management, including our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of the effectiveness of our internal control over financial reporting based on the criteria set forth in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on its evaluation under the criteria set forth in Internal Control-Integrated Framework , our management concluded that our internal control over financial reporting was effective as of December 31, 2020.
This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm pursuant to rules of the Securities and Exchange Commission that permit the Company to provide only management’s report in this Annual Report on Form 10-K.
Changes in internal control over financial reporting
There have been no changes in our internal control over financial reporting that occurred during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
None.
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PART III
Item 10. Directors, Executive Officers, and Corporate Governance
Except as set forth below, the information required by this item is incorporated by reference from our definitive Proxy Statement to be filed with the SEC in connection with our 2021 Annual Meeting of Stockholders within 120 days after the end of the fiscal year ended December 31, 2020.
We have adopted a Code of Business Conduct and Ethics that applies to all directors, officers and employees, including our principal executive officer and principal financial officer. The Code of Business Conduct and Ethics is posted on our website at www.protagonist-inc.com.
We intend to satisfy the disclosure requirement under Item 5.05 of Form 8-K regarding an amendment to, or waiver from, a provision of this Code of Business Conduct and Ethics by posting such information on our website, at the address and location specified above and, to the extent required by the listing standards of The Nasdaq Global Market, by filing a Current Report on Form 8-K with the SEC, disclosing such information.
Item 11. Executive Compensation
The information required by this item is incorporated by reference from our definitive Proxy Statement to be filed with the SEC in connection with our 2021 Annual Meeting of Stockholders within 120 days after the end of the fiscal year ended December 31, 2020.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item is incorporated by reference from our definitive Proxy Statement to be filed with the SEC in connection with our 2021 Annual Meeting of Stockholders within 120 days after the end of the fiscal year ended December 31, 2020.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this item is incorporated by reference from our definitive Proxy Statement to be filed with the SEC in connection with our 2021 Annual Meeting of Stockholders within 120 days after the end of the fiscal year ended December 20, 2020.
Item 14. Principal Accounting Fees and Services
The information required by this item is incorporated by reference from our definitive Proxy Statement to be filed with the SEC in connection with our 2021 Annual Meeting of Stockholders within 120 days after the end of the fiscal year ended December 31, 2020.
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PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) The following documents are filed as part of this report:
(1) FINANCIAL STATEMENTS
The financial statements filed as part of this Annual Report on Form 10-K are included in Part II, Item 8 of this Annual Report on Form 10-K.
(2) FINANCIAL STATEMENT SCHEDULES
Financial statement schedules have been omitted in this Annual Report on Form 10-K because they are not applicable, not required under the instructions, or the information requested is set forth in the financial statements or related notes thereto.
(3) EXHIBITS
The exhibits listed in the accompanying Exhibit Index are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K.
EXHIBIT INDEX
Incorporation By Reference
Exhibit
Filed
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
Herewith
3.1
Amended and Restated Certificate of Incorporation
8-K
001-37852
3.1
8/16/2016
3.2
Amended and Restated Bylaws
S-1/A
333-212476
3.2
8/1/2016
4.1
Specimen stock certificate evidencing the shares of common stock
S-1/A
333-212476
4.1
8/1/2016
4.2
Third Amended and Restated Investor Rights Agreement, by and among Protagonist Therapeutics, Inc. and the stockholders named therein, dated July 31, 2016.
S-1/A
333-212476
4.2
8/1/2016
4.3
Form of Indenture
S-3
333-220314
4.5
9/1/2017
4.4
Form of Class A Common Stock Purchase Warrant
8-K
001-37852
4.1
8/7/2018
4.5
Form of Class B Common Stock Purchase Warrant
8-K
001-37852
4.2
8/7/2018
4.6
Form of Warrant
8-K
001-37852
4.1
12/31/2018
4.7
Description of Protagonist Therapeutics, Inc.’s Securities Registered Pursuant to Section 12 of the Exchange Act
X
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Incorporation By Reference
Exhibit
Filed
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
Herewith
10.1+
Protagonist Therapeutics, Inc. 2007 Stock Option and Incentive Plan, as amended and restated, and form of option agreement, exercise notice, joinder, and adoption agreement thereunder.
S-1
333-212476
10.1
7/11/2016
10.2+
Protagonist Therapeutics, Inc. 2016 Equity Incentive Plan and forms of stock option grant notice, option agreement, notice of exercise, restricted stock unit grant notice and restricted stock unit agreement thereunder.
S-1/A
333-212476
10.2
8/1/2016
10.3+
Protagonist Therapeutics, Inc. 2016 Employee Stock Purchase Plan.
S-1/A
333-212476
10.3
8/1/2016
10.4+
Form of Indemnity Agreement for Directors and Officers.
S-1/A
333-212476
10.4
8/1/2016
10.5+
Amended and Restated Protagonist Therapeutics, Inc. 2018 Inducement Plan, form of stock option grant notice, form of option agreement, form of restricted stock unit grant notice and form of restricted stock unit agreement.
8-K
001-37852
10.1
2/24/2020
10.6
Lease, dated March 6, 2017, by and between the Registrant and BMR-Pacific Research Center LP.
10-K
001-37852
10.9
3/7/2017
10.7+
Severance Agreement, dated August 1, 2016, by and between the Registrant and Dinesh Patel.
S-1/A
333-212476
10.9
8/1/2016
10.8+
Severance Agreement, dated August 1, 2016, by and between the Registrant and David Y. Liu, Ph.D.
S-1/A
333-212476
10.10
8/1/2016
10.9+
Employment Offer Letter, dated May 21, 2018, by and between the Registrant and Samuel Saks, M.D.
10-Q
001-37852
10.2
8/7/2018
10.10†
Research and Collaboration Agreement, dated June 16, 2012, by and among the Registrant, Protagonist Pty. Ltd. and Zealand Pharma A/S.
S-1
333-212476
10.17
7/11/2016
10.11†
Contract Extension Letter of Agreement, dated June 1, 2013, by and among the Registrant, Protagonist Pty. Ltd. and Zealand Pharma A/S .
S-1
333-212476
10.18
7/11/2016
10.12†
Agreement on Addition of Additional Collaboration Program, dated September 16, 2013, by and among the Registrant, Protagonist Pty. Ltd. and Zealand Pharma A/S.
S-1
333-212476
10.19
7/11/2016
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Incorporation By Reference
Exhibit
Filed
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
Herewith
10.13†
Protagonist Assumption of Responsibility, dated January 28, 2014, by and between the Registrant and Zealand Pharma A/S.
S-1
333-212476
10.20
7/11/2016
10.14†
Agreement to Assign Patent Applications, dated February 7, 2014, by and between the Registrant, Protagonist Pty. Ltd. and Zealand Pharma A/S.
S-1
333-212476
10.21
7/11/2016
10.15†
Abandonment Agreement, dated February 28, 2014, by and among the Registrant, Protagonist Pty. Ltd. and Zealand Pharma A/S.
S-1
333-212476
10.22
7/11/2016
10.16†
Exclusive License and Collaboration Agreement, dated May 26, 2017, by and between the Registrant and Janssen Biotech, Inc.
8-K/A
001-37852
10.1
7/31/2017
10.17
Registration Rights Agreement, dated August 8, 2018, by and between the Registrant and certain parties identified on the signature pages thereto
8-K
001-37852
4.3
8/7/2018
10.18
Securities Purchase Agreement, dated August 6, 2018, by and between the Registrant and certain purchasers identified on the signature pages thereto
S-3
333-227216
10.1
9/7/2018
10.19
Exchange Agreement, dated December 21, 2018, by and between the Registrant and Biotechnology Value Fund, L.P., Biotechnology Value Fund II, L.P. and Biotechnology Value Trading Fund OS, L.P.
8-K
001-37852
10.1
12/31/2018
10.20
First Amendment, dated January 31, 2019, to Lease, dated March 6, 2017, by and between Protagonist Therapeutics, Inc., as Tenant, and BMR-Pacific Research Center LP, as Landlord .
10-Q
001-37852
10.3
5/8/2019
10.21+
Severance Agreement, dated March 14, 2019, by and among Protagonist Therapeutics, Inc. and Suneel Gupta, Ph.D.
10-Q
001-37852
10.4
5/8/2019
10.22#
First Amendment to Exclusive License and Collaboration Agreement, by and between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., dated May 7, 2019.
10-Q
001-37852
10.1
8/7/2019
10.23+
Offer Letter, by and between Protagonist Therapeutics Inc. and Donald Kalkofen, dated May 20, 2019.
8-K
001-37852
10.1
5/29/2019
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Incorporation By Reference
Exhibit
Filed
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
Herewith
10.24+
Severance Agreement, dated July 19, 2019, by and between Protagonist Therapeutics, Inc. and Samuel Saks, M.D.
10-Q
001-37852
10.1
11/6/2019
10.25
Credit and Security Agreement, dated October 30, 2019, by and between Protagonist Therapeutics, Inc., MidCap Financial, and Silicon Valley Bank.
10-K
001-37852
10.25
3/10/2020
10.26
Open Market Sale Agreement SM , dated November 27, 2019, by and between Protagonist Therapeutics, Inc. and Jefferies LLC.
8-K
001-37852
10.1
11/27/2019
10.27+
Severance Agreement, dated August 4, 2020, by and between Protagonist Therapeutics, Inc. and Donald Kalkofen.
10-Q
001-37852
10.1
8/6/2020
21.1
List of Subsidiaries
X
23.1
Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm
X
23.2
Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting Firm
X
24.1
Power of Attorney (included in signature page of this Form 10-K)
X
31.1
Certification of Chief Executive Officer required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2
Certification of Chief Financial Officer required by Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1*
Certification of Chief Executive Officer and Chief Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
101.INS
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL Document
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
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Incorporation By Reference
Exhibit
Filed
Number
Exhibit Description
Form
SEC File No.
Exhibit
Filing Date
Herewith
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Labels Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104
Cover Page Interactive Data File – the cover page interactive data file does into appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document
X
+ Indicates management contract or compensatory plan, contract or agreement.
† Confidential treatment has been granted for a portion of this exhibit.
* This certification attached as Exhibit 32.1 that accompanies this Annual Report on Form 10-K is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Protagonist Therapeutics, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of the Form 10-K, irrespective of any general incorporation language contained in such filing.
# Portions of this exhibit (indicated by hashtag) have been omitted as the registrant has determined that (i) the omitted information is not material and (ii) the omitted information would likely cause competitive harm to the registrant if publicly disclosed.
Item 16. Form 10-K Summary
None.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
PROTAGONIST THERAPEUTICS, INC.
Date: March 10, 2021
By:
/s/ Dinesh V. Patel, Ph.D.
Dinesh V. Patel, Ph.D.
President, Chief Executive Officer and Director
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Dinesh V. Patel and Don Kalkofen, and each of them, his true and lawful attorneys-in-fact, with full power of substitution, for him in any and all capacities, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with exhibits thereto and other documents in connection therewith with the Securities and Exchange Commission, hereby ratifying and confirming all that said attorneys-in-fact or any of them or their substitute or substitutes may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant in the capacities and on the dates indicated:
Signature
Title
Date
/s/ Dinesh V. Patel, Ph.D.
President, Chief Executive Officer and Director
March 10, 2021
Dinesh V. Patel, Ph.D.
(Principal Executive Officer)
/s/ Don Kalkofen
Chief Financial Officer
March 10, 2021
Don Kalkofen
(Principal Financial and Accounting Officer)
/s/ Harold E. Selick, Ph.D.
Chairman of the Board of Directors
March 10, 2021
Harold E. Selick, Ph.D.
/s/ Bryan Giraudo
Director
March 10, 2021
Bryan Giraudo
/s/ Sarah Noonberg, M.D., Ph.D.
Director
March 10, 2021
Sarah Noonberg, M.D., Ph.D.
/s/ Sarah O’Dowd
Director
March 10, 2021
Sarah O’Dowd
/s/ William D. Waddill
Director
March 10, 2021
William D. Waddill
/s/ Lewis T. Williams, M.D., Ph.D.
Director
March 10, 2021
Lewis T. Williams, M.D., Ph.D.
117