Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES.
Evaluation of Disclosure Controls and Procedures
Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their objectives of ensuring that information we are required to disclose in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our chief executive officer (CEO) and chief financial officer (CFO), as appropriate, to allow timely decisions regarding required disclosures, and is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. There is no assurance that our disclosure controls and procedures will operate effectively under all circumstances.
Management’s Report on Internal Control Over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over financial reporting as such term is defined in Rule 13a-15(f) under the Exchange Act. Internal control over financial reporting is a process designed under the supervision and with the participation of our management, including our CEO and CFO, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; and (ii) provide reasonable assurance (a) that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, (b) that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and (c) regarding the prevention or timely detection of the unauthorized acquisition, use or disposition of assets that could have a material effect on our financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
As of December 31, 2021, our management conducted an evaluation of the effectiveness of our internal control over financial reporting using the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control - Integrated Framework (2013). Based on this evaluation, our management concluded that, as of December 31, 2021, our internal control over financial reporting was effective.
The effectiveness of the company’s internal control over financial reporting has been audited by Ernst & Young LLP, our independent registered public accounting firm, as stated in its attestation report appearing on page 136 of this Annual Report under the heading “Report of Independent Public Accounting Firm on Internal Control Over Financial Reporting”, which expresses an unqualified opinion concerning the effectiveness of the company’s internal control over financial reporting as of December 31, 2021.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the fiscal quarter ended December 31, 2021, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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Inherent Limitations on Effectiveness of Controls
Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the controls. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.
ITEM 9B. OTHER INFORMATION.
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
The information required by this item will be contained in our definitive proxy statement to be filed with the Securities and Exchange Commission on Schedule 14A in connection with our 2022 Annual Meeting of Stockholders (the Proxy Statement), which is expected to be filed not later than 120 days after the end of our fiscal year ended December 31, 2021, and is incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION.
The information required by this item will be contained in the Proxy Statement under the headings “Executive Compensation” and “Board of Directors and Corporate Governance – Director Compensation,” and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
The information required by this item will be contained in the Proxy Statement under the headings “Security Ownership of Certain Beneficial Owners and Management” and “Executive Compensation – Equity Compensation Plan Information,” and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
The information required by this item will be contained in the Proxy Statement under the headings “Certain Relationships and Related Party Transactions” and “Board of Directors and Corporate Governance,” and is incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
The information required by this item will be contained in the Proxy Statement under the heading “Ratification of Appointment of Independent Registered Public Accounting Firm – Fees Paid to the Independent Registered Public Accounting Firm” and is incorporated herein by reference.
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PART IV
ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES.
The consolidated financial statements, financial statement schedules and exhibits filed as part of this Annual Report are as follows:
(1) Financial Statements
Reference is made to the consolidated financial statements identified in the “Index to Financial Statements” under P art II, Item 8. “Financial Statements and Supplementary Data” of this Annual Report.
(2) Financial Statement Schedules for the Years Ended December 31, 2021, 2020 and 2019
All financial statement schedules have been omitted because the information required to be set forth therein is not applicable or is otherwise included in the consolidated financial statements or notes thereto. See Part II, Item 8. “Financial Statements and Supplementary Data” of this Annual Report.
(3) Exhibits
The documents listed below are incorporated by reference or filed with this Annual Report, in each case as indicated therein (numbered in accordance with Item 601 of Regulation S-K).
Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
2.1† Agreement and Plan of Merger, dated December 21, 2020, by and among ImmunityBio, Inc. (f/k/a NantKwest, Inc.), NantCell, Inc. (f/k/a ImmunityBio, Inc.) and Nectarine Merger Sub, Inc.
8-K 001-37507 2.1 December 22, 2020
3.1 Amended and Restated Certificate of Incorporation of ImmunityBio, Inc.
8-K 001-37507 3.1 August 4, 2015
3.2 Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunityBio, Inc. dated March 9, 2021.
8-K 001-37507 3.1 March 10, 2021
3.3 Certificate of Amendment of Amended and Restated Certificate of Incorporation of ImmunityBio, Inc. dated February 1, 2022.
POSASR 333-255699 3.3 March 1, 2022
3.4 Amended and Restated Bylaws of ImmunityBio, Inc . effective as of March 10, 2021.
10-Q 001-37507 3.2 August 12, 2021
4.1 Nominating Agreement by and between the Registrant and Cambridge Equities, LP, dated June 18, 2015.
S-1 333-205124 4.1 June 19, 2015
4.2 Form of Registration Rights Agreement by and between the Registrant and the Purchasers of Common Stock, dated June 2015.
S-1 333-205124 4.2 June 19, 2015
4.3 Registration Rights Agreement by and between the Registrant and Cambridge Equities LP. dated December 23, 2014.
S-1 333-205124 4.3 June 19, 2015
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Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
4.4 Form of Subscription and Securities Purchase Agreement among the Registrant and the Subscribers of Series C Preferred Stock, dated as of April 1, 2014.
S-1 333-205124 4.5 June 19, 2015
4.5 Registration Rights Agreement, among the Registrant and the purchasers of Series B Preferred Stock, dated as of June 20, 2013.
S-1 333-205124 4.6 June 19, 2015
4.6 Specimen Common Stock Certificate.
S-8 POS 333-252232 4.1 May 21, 2021
4.7* Description of Registrant’s Securities.
10.1 Voting Agreement, dated as of December 21, 2020, by and among ImmunityBio, Inc., NantKwest, Inc. and the NantKwest, Inc. stockholders party thereto.
8-K 001-37507 10.1 December 22, 2020
10.2 Voting Agreement, dated as of December 21, 2020, by and among ImmunityBio, Inc., NantKwest, Inc. and the ImmunityBio, Inc. stockholders party thereto.
8-K 001-37507 10.2 December 22, 2020
10.3+ Common Stock Purchase Warrant, dated June 30, 2016, issued by the Company to NantWorks, LLC.
S-4 333-252232 10.13 January 19, 2021
10.4† Common Stock Purchase Agreement, dated April 30, 2018, by and among ImmunityBio, Inc. and NantBio, Inc.
S-4 333-252232 10.30 January 19, 2021
10.5 Open Market Sale Agreement dated April 30, 2021, by and between ImmunityBio, Inc. and Jefferies LLC.
8-K 001-37507 10.1 May 3, 2021
10.6† Agreement and Plan of Merger, dated May 19, 2017, by and among the Company, Altor Acquisition LLC, Altor BioScience Corporation and Shareholder Representative Services LLC.
S-4 333-252232 10.4 January 19, 2021
10.7 FDA Milestone Contingent Value Rights Agreement, dated as of July 31, 2017, by and between the Company and Shareholder Repre sentative Services LLC .
S-4 333-252232 10.11 January 19, 2021
10.8 S ales Milestone Contingent Value Rights Agreement, dated as of July 31, 2017, by and between the Company and Shareholder Representative Services LLC.
S-4 333-252232 10.12 January 19, 2021
10.9† Agreement and Plan of Merger, entered into as of May 15, 2018, by and among the Company, Receptome Acquisition Corporation, Receptome, Inc., and the Selling Stockholder thereunder.
S-4 333-252232 10.5 January 19, 2021
10.10 Promissory Note by and between ImmunityBio, Inc. and Nant Capital, LLC dated as of December 17, 2021.
8-K 001-37507 10.1 December 20, 2021
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Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
10.11 Promissory Note issued by ImmunityBio, Inc. to Nant Capital, LLC dated February 22, 2021.
8-K 001-37507 10.14 March 10, 2021
10.12 Promissory Note issued by ImmunityBio, Inc. to Nant Capital, LLC dated September 30, 2020.
S-4 333-252232 10.10 January 19, 2021
10.13 Amended and Restated Promissory Note issued by ImmunityBio, Inc. t o Nant Capital, LLC dated July 28, 2020.
S-4 333-252232 10.6 January 19, 2021
10.14 Amended and Restated Promissory Note issued by ImmunityBio, Inc. to NantWorks, LLC dated July 28, 2020.
S-4/A 333-252232 10.7 January 19, 2021
10.15 Amended and Restated Promissory Note issued by ImmunityBio, Inc. to NantCancerStemCell, LLC dated July 28, 2020.
S-4/A 333-252232 10.8 January 19, 2021
10.16 Amended and Restated Promissory Note issued by ImmunityBio, Inc. to NantMobile, LLC dated July 28, 2020.
S-4/A 333-252232 10.9 January 19, 2021
10.17 Lease Agreement by and between ARE - JOHN HOPKINS COUR T , LLC and the Company, dated June 19, 2015.
S-1/A 333-205124 10.19 July 27, 2015
10.18 Facility License Agreement by and between NantWorks, LLC and the Company , dated as of November 6, 2015.
10-K 001-37507 10.23 March 30, 2016
10.19 First Amendment to Facility License Agreement by and between NantWorks, LLC and the Company , dated as of September 14, 2020.
10-Q 001-37507 10.2 November 9, 2020
10.20 Commercial Lease by and between 605 Doug St, LLC and the Company, dated September 15, 2016.
10-Q 001-37507 10.1 November 10, 2016
10.21+ Commercial Lease by and between Duley Road, LLC and Altor BioScience Manufacturing Company, LLC dated February 1, 2017.
S-4/A 333-252232 10.27 January 19, 2021
10.22+ Commercial Lease by and between Duley Road, LLC and the Company dated January 28, 2019.
S-4/A 333-252232 10.28 January 19, 2021
10.23+ Commercial Lease by and between Duley Road, LLC and the Company dated January 28, 2019.
S-4/A 333-252232 10.29 January 19, 2021
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Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
10.24 Sublease Agreement between Altor BioScience Manufacturing Company, LLC and the Company, dated as of September 30, 2020.
10-Q 001-37507 10.3 November 9, 2020
10.25 Commercial Lease between 605 Nash, LLC and the Company, dated February 11, 2021.
10-K 001-37507 10.35 March 4, 2021
10.26 First Amendment to Lease (Expansion & Extension) made and entered into as of May 28, 2021 by and between 605 Nash, LLC and Imm unityBio, Inc .
10-Q 001-37507 10.1 August 12, 2021
10.27 Membership Interest Purchase Agreement ente red into as of September 27, 2021 by and among Nant Capital, LLC and ImmunityBio, Inc.
10-Q 001-37507 10.2 November 12, 2021
10.28 Industrial/Commercial Lease Agreement dated September 27, 2021 by and between 557 Doug St, LLC and ImmunityBio, Inc.
10-Q 001-37507 10.3 November 12, 2021
10.29 Commercial Lease Agreement dated September 27, 2021 by and between 420 Nash, LLC and ImmunityBio, Inc.
10-Q 001-37507 10.4 November 12, 2021
10.30 †
Purchase Agreement by and between Athenex, Inc. and ImmunityBio, Inc. dated January 7, 2022 .
8-K 001-37507 10.1 January 12, 2022
10.31+ Letter Agreement effective as of July 1, 2019 between Immuno-Oncology Clinic, Inc. and the Company.
10-Q 001-37507 10.4 August 6, 2019
10.32 First Amendment to the July 1, 2019 Letter Agreement by and between Immuno-Oncology Clinic, Inc. and the Company dated March 31, 2020.
10-Q 001-37507 10.1 May 11, 2020
10.33#+ Amended and Restated Executive Employment Agreement between the Company and Patrick Soon-Shiong, M.D., dated July 13 , 2015.
S-1/A 333-205124 10.5 July 15, 2015
10.34#^ Offer Letter between the Company and Richard Adcock, dated October 26, 2020.
10-Q 001-37507 10.4 November 9, 2020
10.35#^ Offer Letter, dated August 3, 2020, between ImmunityBio, Inc. and David Sachs.
S-4 333-252232 10.31 January 19, 2021
10.36*#^ Offer Letter, dated October 12, 2021, by and among ImmunityBio, Inc. and Regan Lauer.
10.37# Executive Employment Agreement between the Company and Barry J. Simon, M.D., dated January 1, 2015.
S-1 333-205124 10.6 June 19, 2015
10.38# Letter Agreement with Barry Simon dated May 3, 2018.
10-Q 001-37507 10.1 August 6, 2018
10.39#^ Offer Letter between Sonja Nelson and the Company, dated April 7, 2016.
10-Q 001-37507 10.1 May 16, 2016
10.40#^ Revised Offer of Employment Letter with Sonja Nelson dated June 11, 2018.
10-Q 001-37507 10.2 August 6, 2018
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Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
10.41# ImmunityBio, Inc. Outside Director Compensation Policy as of March 9, 2021.
8-K 001-37507 10.1 March 10, 2021
10.42 Form of Indemnification Agreement between ImmunityBio, Inc. and each of its Directors and Executive Officers.
S-1 333-205124 10.1 June 19, 2015
10.43# Executive Incentive Compensation Plan.
S-1/A 333-205124 10.4 July 15, 2015
10.44# 2014 NantKwest, Inc. Equity Incentive Plan and Forms of Agreement Thereunder.
S-1 333-205124 10.2 June 19, 2015
10.45# 2015 NantKwest, Inc. Equity Incentive Plan (as Amended and Restated June 10, 2020) and a ll f orms and a greements t hereunder.
10-Q 001-37507 10.1 August 7, 2020
10.46# NantCell, Inc. 2015 Stock Incentive Plan and f orm s of a greement t hereunder.
S-4 333-252332 10.14 January 19, 2021
10.47 Assignment Agreement, dated July 2, 2017, by and between NantPharma, LLC and Immunotherapy NANTibody, LLC.
S-4 333-252332 10.25 January 19, 2021
10.48 Letter Agreement, dated February 14, 2018, by and between NantPharma, LLC and Immunother a p y NANTibody, LLC.
S-4 333-252332 10.26 January 19, 2021
10.49 Notice of Pendancy of Proposed Settlement of Stockholder Derivative Action dated May 31, 2019.
8-K 001-37507 99.1 June 10, 2019
10.50 Stipulation and Agreement of Settlement dated April 10, 2019.
8-K 001-37507 99.2 June 10, 2019
21.1* Subsidiaries of ImmunityBio, Inc. as of December 31, 2021.
23.1* Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
24.1* Power of Attorney (Contained in Signature Page to this Annual Report on Form 10-K).
31.1* Rule 13a-14(a)/15(d)-14(a) Certification of Principal Executive Officer.
31.2* Rule 13a-14(a)/15(d)-14(a) Certification of Principal Financial Officer.
32.1** Section 1350 Certification of Chief Executive Officer.
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Exhibit
Number Incorporated by Reference Herein
Description Form File No. Exhibit No. Filing Date
32.2** Section 1350 Certification of Chief Financial Officer.
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).
101.SCH Inline XBRL Taxonomy Extension Schema Document.
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document.
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document.
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document.
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document.
104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
_______________
* Filed herewith.
** The certifications attached as Exhibits 32.1 and 32.2 that accompany this Annual Report are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of ImmunityBio, 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 this Annual Report, irrespective of any general incorporation language contained in such filing.
† Schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The company agrees to furnish to the SEC a copy of any omitted schedule or exhibit upon request.
+ Schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The company agrees to furnish to the SEC a copy of any omitted schedule or exhibit upon request.
# Indicates a management contract or compensatory plan.
^ Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(a)(6).
ITEM 16. FORM 10-K SUMMARY.
None.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Act of 1934, as amended, the registrant has duly caused this Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized.
IMMUNITYBIO, INC.
Registrant
Date: March 1, 2022
By: /s/ Richard Adcock
Richard Adcock
Chief Executive Officer
(Principal Executive Officer)
Date: March 1, 2022
By: /s/ David C. Sachs
David C. Sachs
Chief Financial Officer
(Principal Financial Officer)
Date: March 1, 2022
By: /s/ Regan J. Lauer
Regan J. Lauer
Chief Accounting Officer
(Principal Accounting Officer)
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POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Richard Adcock, David C. Sachs and Jason Liljestrom, and each of them, as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, 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 all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitutes, may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report on Form 10-K 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/ Patrick Soon-Shiong Global Chief Scientific and Medical Officer, and
Executive Chairman of the Board of Directors March 1, 2022
Patrick Soon-Shiong
/s/ Richard Adcock Chief Executive Officer, President and Director
(Principal Executive Officer)
March 1, 2022
Richard Adcock
/s/ David C. Sachs Chief Financial Officer
(Principal Financial Officer)
March 1, 2022
David C. Sachs
/s/ Regan J. Lauer Chief Accounting Officer
(Principal Accounting Officer)
March 1, 2022
Regan J. Lauer
/s/ Barry J. Simon Chief Corporate Affairs Officer and Director March 1, 2022
Barry J. Simon
/s/ Michael D. Blaszyk Director March 1, 2022
Michael D. Blaszyk
/s/ John Owen Brennan Director March 1, 2022
John Owen Brennan
/s/ Wesley Clark Director March 1, 2022
Wesley Clark
/s/ Cheryl L. Cohen Director March 1, 2022
Cheryl L. Cohen
/s/ Linda Maxwell Director March 1, 2022
Linda Maxwell
/s/ Christobel Selecky Director March 1, 2022
Christobel Selecky
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