Item 9A. Controls and Procedures
ITEM 9A – CONTROLS AND PROCEDURES
Evaluation of Disclosure
Controls and Procedures
Our management, with
the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and
procedures as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”),
as of the end of the period covered by this Annual Report on Form 10-K.
Based on this evaluation
our management, including our Chief Executive Officer and Chief Financial Officer, concluded that, as of December 31, 2022, our disclosure
controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information
we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported
within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our
management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate,
to allow timely decisions regarding required disclosure.
Management’s
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 Rule 13a-15(f) of the
Exchange Act. Management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer,
conducted an assessment of the design and effectiveness of our internal control over financial reporting as of the end of the period covered
by this Annual Report on Form 10-K. In making its assessment of internal control over financial reporting, management used the criteria
set forth by the Committee of Sponsoring Organizations (“COSO”) of the Treadway Commission in Internal Control —
Integrated Framework (2013 Framework) . Based on this assessment, our management concluded that, as of the end of the period covered
by this Annual Report on Form 10-K, our internal control over financial reporting was effective based on the criteria set forth by COSO
of the Treadway Commission in Internal Control — Integrated Framework.
This annual report does
not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. Management’s
report was not subject to attestation by our registered public accounting firm pursuant to an exemption for non-accelerated filers set
forth in Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.
Changes in Internal
Control Over Financial Reporting
There have been no changes
in our internal control over financial reporting that occurred during the quarterly period covered by this Annual Report on Form 10-K
that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
68
Limitations on Effectiveness
of Controls and Procedures
In designing and evaluating
the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated,
can provide only reasonable assurance of achieving the desired control objectives. The Company’s internal control over financial
reporting includes those policies and procedures that:
(1)
Pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets;
(2)
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that the Company’s receipts and expenditures are being made only in accordance with authorizations of the Company’s management and directors; and
(3)
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company’s assets that could have a material effect on the financial statements.
Management, including
the Company’s principal executive and principal financial officers, or persons performing similar functions, does not expect that
the Company’s internal controls will prevent or detect all errors and all fraud. A control system, no matter how well designed 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 internal controls can provide absolute assurance
that all control issues and instances of fraud, if any, have been detected. Also, any evaluation of the effectiveness of controls in future
periods are subject to the risk that those internal controls may become inadequate because of changes in business conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
ITEM 9B – OTHER INFORMATION
Scripps Research
On March 17, 2023, the Company and Scripps Research
entered into a Research Funding and Option Agreement (the “Agreement”), pursuant to which the Company has agreed to provide
Scripps Research an aggregate of up to $938,000 to fund research relating to advancing the pre-clinical development of the Company’s
DNase oncology platform technology. The research funding is payable by the Company to Scripps Research on a monthly basis in accordance
with a negotiated budget, which provides for an initial payment of approximately $78,000 on the date of the Agreement and subsequent monthly
payments of approximately $78,000 over a 12-month period. Under the Agreement, the Company has the option to acquire a worldwide exclusive
license to Scripps Research’s rights in the Technology or Patent Rights (as defined in the Agreement), as well as a non-exclusive,
royalty-free, non-transferrable license to make and use TSRI Technology (as defined in the Agreement) solely for the Company’s internal
research purposes during the performance of the research program contemplated by the Agreement.
Unless earlier terminated, the term of the Agreement continues from
the date of the Agreement for fifteen (15) months. The Agreement may be terminated by the Company with 30 days advance written notice
to Scripps Research beginning six (6) months after the Effective Date (as defined in the Agreement) or by Scripps Research if the Company
fails to make timely payments due under the Agreement, subject to 30 days’ written notice to cure such nonpayment. The Agreement
may further be terminated by either party in the event of the other party’s uncured failure to perform any obligations under the
Agreement or the bankruptcy of the other party.
A copy of the Agreement
will be filed as an exhibit to the Company’s quarterly report on From 10-Q for the three month period ending March 31, 2023.
ITEM 9C – DISCLOSURE REGARDING FOREIGN
JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
69
PART
III
ITEM 10 – DIRECTORS, EXECUTIVE OFFICERS
AND CORPORATE GOVERNANCE
The information required
by this Item will be set forth in the Company’s definitive proxy statement or information statement to be filed with the SEC in
connection with the Company’s 2023 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year
ended December 31, 2022 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K.
ITEM 11 – EXECUTIVE COMPENSATION
The information required
by this Item will be set forth in the Company’s definitive proxy statement or information statement to be filed with the SEC in
connection with the Company’s 2023 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year
ended December 31, 2022 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K.
ITEM 12 – SECURITY OWNERSHIP OF CERTAIN
BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The information required
by this Item will be set forth in the Company’s definitive proxy statement or information statement to be filed with the SEC in
connection with the Company’s 2023 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year
ended December 31, 2022 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K.
ITEM 13 – CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required
by this Item will be set forth in the Company’s definitive proxy statement or information statement to be filed with the SEC in
connection with the Company’s 2023 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year
ended December 31, 2022 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K.
ITEM 14 – PRINCIPAL ACCOUNTING FEES AND
SERVICES
The information required
by this Item will be set forth in the Company’s definitive proxy statement or information statement to be filed with the SEC in
connection with the Company’s 2023 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year
ended December 31, 2022 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K.
70
PART IV
ITEM 15 – EXHIBITS AND FINANCIAL STATEMENT
SCHEDULES
(a)
The following is filed as part of this Annual Report on Form 10-K:
·
Consolidated Financial Statements: The consolidated financial statements and report of independent registered public accounting firm required by this item are included in Part II, Item 8;
·
Financial Statement Schedules: All schedules are omitted because they are not applicable or not required, or because the required information is shown either in the consolidated financial statements or in the notes thereto.
(b)
Exhibits: The
exhibits which are filed or furnished with this Annual Report on Form 10-K or which are incorporated herein by reference are set
forth in the Exhibit Index beginning on page 72 which is incorporated herein by reference.
ITEM 16 – FORM 10-K SUMMARY
Not applicable.
71
EXHIBIT INDEX
Exhibit
No.
Exhibit
Index
Form
Filing Date
Exhibit
Number
Filed
Herewith
3.1
Articles
of Incorporation
S-1
11/21/2011
3.1
3.2
Certificate
of Amendment to Articles of Incorporation
8-K
02/12/2013
3.1
3.3
Certificate
of Amendment to Articles of Incorporation
8-K
02/27/2013
3.1
3.4
Certificate
of Amendment to Articles of Incorporation
10-Q
01/10/2014
3.1
3.5
Certificate
of Change Pursuant to NRS 78.209
10-Q
01/10/2014
3.2
3.6
Certificate
of Amendment to Articles of Incorporation
8-K
09/30/2015
3.1
3.7
Amended
and Restated Bylaws
8-K
02/27/2017
3.1
3.8
Form
of Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series A Preferred Stock
S-1/A
10/27/2016
3.8
3.9
Second
Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series B Preferred Stock
S-1/A
10/31/2016
3.9
3.10
Certificate
of Change Pursuant to NRS 78.209
8-K
06/24/2019
3.1
3.11
Certificate
of Amendment to Articles of Incorporation
8-K
06/24/2019
3.2
3.12
Certificate
of Amendment to Articles of Incorporation
10-K
03/16/2021
3.12
3.13
Certificate
of Amendment to Articles of Incorporation
10-K
03/16/2021
3.13
3.14
Certificate of Amendment to Articles of Incorporation
X
4.1
Description of Registrant’s Securities Registered Pursuant to Section 12 of the Securities Exchange Act of 1934
X
4.2
Form
of Common Stock Certificate of the Registrant
S-1/A
07/14/2016
4.1
4.3
Registration
Rights Agreement, dated July 1, 2015, between Xenetic Bioscience, Inc. and OJSC Pharmsynthez
8-K
07/08/2015
10.3
4.4
Form
of First Amendment to Registration Rights Agreement
8-K
11/16/2015
10.8
4.5
Form
of Common Stock Purchase Warrant
8-K
06/25/2019
4.1
4.6
Form
of Common Stock Purchase Warrant
8-K
07/22/2019
4.2
4.7
Form
of Series A Warrant
8-K
07/28/2021
4.1
10.1†
Form
of Amended and Restated Xenetic Biosciences, Inc. Equity Incentive Plan, as amended, effective as of December 7, 2021
DEF14A
10/15/2021
Appendix A
10.2#
Agreement
on Co-Development and the Terms of Exclusive License dated August 4, 2011 between Lipoxen plc, Lipoxen Technologies LTD and SynBio
LLC
10-K/A
02/18/2015
10.18
10.3
Novation of Agreement on Co-Development and the Terms
of Exclusive License, dated December 17, 2021, between Xenetic Biosciences (UK) Limited (formerly Lipoxen plc), Lipoxen Technologies
Limited, SynBio LLC and Public Joint-Stock Company Pharmsynthez
10-K
03/22/2022
10.3
10.4##
Exclusive License Agreement, dated December 20, 2021,
between Lipoxen Technologies Limited and Public Joint-Stock Company Pharmsynthez
10-K
03/22/2022
10.4
72
Exhibit
No.
Exhibit
Index
Form
Filing Date
Exhibit
Number
Filed
Herewith
10.5#
Subscription
Agreement in respect of ordinary shares in the capital of Lipoxen plc dated August 4, 2011 between SynBio LLC and Lipoxen plc
10-K/A
02/18/2015
10.19
10.6#
Collaboration,
License and Development Agreement, dated November 11, 2009, between Pharmsynthez ZAO and Lipoxen Technologies Ltd.
10-K/A
02/18/2015
10.20
10.7#
Exclusive
Patent and Know How License and Manufacturing Agreement, dated August 4, 2011, between Lipoxen plc, Lipoxen Technologies Ltd and
Serum Institute of India Limited
10-K/A
02/18/2015
10.21
10.8
Intellectual
Property Assignment between Dmitry Genkin, FDS Pharma, Lipoxen Technologies Limited and Xenetic Biosciences Inc.
10-K
04/15/2015
10.1
10.9†
Employment
Agreement, dated December 1, 2016, between Xenetic Biosciences, Inc. and Jeffrey Eisenberg
8-K
12/6/2016
10.1
10.10†
Employment
Agreement, dated January 1, 2017 between Xenetic Biosciences, Inc. and Curtis Lockshin
8-K
01/04/2017
10.1
10.11†
Employment
Agreement, dated March 23, 2017 between Xenetic Biosciences, Inc. and James F. Parslow
8-K
04/04/2017
10.1
10.12†
Form
of Indemnity Agreement by and between Xenetic Biosciences, Inc. and each of its directors and executive officers
10-Q
08/14/2017
10.1
10.13†
Amended
and Restated Employment Agreement, dated October 26, 2017, between Xenetic Biosciences, Inc. and Jeffrey Eisenberg
10-K
03/30/2018
10.45
10.14#
Right
to Sublicense Agreement, dated October 27, 2017, by and among Xenetic Biosciences, Inc., Baxalta Incorporated, Baxalta US Inc., and
Baxalta GmbH
10-K
03/30/2018
10.46
10.15
Assignment
Agreement between Xenetic Biosciences, Inc. and OPKO Pharmaceuticals, LLC, dated March 1, 2019
8-K/A
05/20/2019
10.1
10.16
First
Amendment to Assignment Agreement dated June 7, 2019
8-K
06/13/2019
10.1
10.17
Second
Amendment to Assignment Agreement dated June 24, 2019
8-K
06/24/2019
10.1
10.18
Third
Amendment to Assignment Agreement dated July 15, 2019
8-K
07/16/2019
10.1
10.19
Form
of Consent Agreement by and among Xenetic Biosciences, Inc. and certain purchasers dated June 24, 2019
8-K
06/25/2019
10.1
10.20
Warrant
Agency Agreement, between Xenetic Biosciences, Inc. and Empire Stock Transfer, Inc. dated July 19, 2019
8-K
07/22/2019
10.1
10.21
Consent
Agreement by and among Xenetic Biosciences, Inc. and certain purchasers dated July 16, 2019
8-K
07/16/2019
10.1
10.22†
Form
of Letter Agreement re. Appointment of Non – Employee, Independent Director of Xenetic Biosciences, Inc.
10-K
03/26/2020
10.51
10.23†
Form
of Xenetic Biosciences, Inc. Stock Option Grant Notice
10-K
03/26/2020
10.52
10.24†
Xenetic
Biosciences, Inc. Stock Option Grant Notice, dated December 4, 2019, between Jeffrey Eisenberg and Xenetic Biosciences, Inc.
10-K
03/26/2020
10.53
10.25##
Research
Funding and Option Agreement, dated May 15, 2020, between the Company and the Scripps Research Institute
10-Q
08/12/2020
10.1
73
Exhibit
No.
Exhibit
Index
Form
Filing Date
Exhibit
Number
Filed
Herewith
10.26##
Master
Service Agreement, dated June 12, 2020, between the Company and PJSC Pharmsynthez
10-Q
08/12/2020
10.2
10.27##
Amendment Number One to the Master Services Agreement,
dated October 12, 2021, between the Company and PJSC Pharmsynthez
10-K
03/22/2022
10.28
10.28##
Second Work Order to Master Service Agreement, dated
October 12, 2021, between the Company and PJSC Pharmsynthez
10-K
03/22/2022
10.29
10.29
Form
of Securities Purchase Agreement, dated July 26, 2021, by and among the Company and the other parties thereto
8-K
7/28/2021
10.1
10.30
Form
of Registration Rights Agreement, dated July 26, 2021, by and among the Company and the other parties thereto
8-K
7/28/2021
10.2
10.31
Form
of Letter Agreement by and between Xenetic Biosciences, Inc. and the Holders, dated November 15, 2021
8-K
11/16/2021
10.1
10.32
At
The Market Offering Agreement by and between Xenetic Biosciences, Inc. and H.C. Wainwright & Co., LLC, dated November 19, 2021
8-K
11/19/2021
1.1
10.33##
Exclusive Sublicense Agreement, dated April 26, 2022,
between Xenetic Biosciences, Inc. and CLS Therapeutics LTD
10-Q
8/11/2022
10.1
10.34##
Exclusive License Agreement, dated April 26, 2022,
between Xenetic Biosciences, Inc. and CLS Therapeutics LTD
10-Q
8/11/2022
10.2
10.35
Form of Subscription Agreement, dated April 26, 2022,
between Xenetic Biosciences, Inc. and CLS Therapeutics LTD
10-Q
8/11/2022
10.3
10.36##
Statement of Work, dated June 30, 2022, between Xenetic
Biosciences, Inc. and Catalent Pharma Solutions, LLC
10-Q
8/11/2022
10.4
21.1
List of Subsidiaries
X
23.1
Consent of Marcum LLP
X
24.1
Power of Attorney (included on signature page)
X
31.1
Certification of Principal Executive Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
X
31.2
Certification of Principal Financial Officer, as required by Rule 13a-14(a) or Rule 15d-14(a)
X
32.1*
Certification of Principal Executive Officer and Principal Financial Officer, as required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 36 of Title 18 of the United States Code (18 U.S.C. §1350)
X
101.INS
Inline XBRL Instance Document.
X
101.SCH
Inline XBRL Taxonomy Extension
Schema Document.
X
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
Label Linkbase Document.
X
101.PRE
Inline XRBL Taxonomy Extension
Presentation Linkbase Document.
X
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document)
X
†
#
##
Indicates a management contract or any compensatory
plan, contract or arrangement.
Application has been made with the Securities
and Exchange Commission to seek confidential treatment of certain confidential material contained in this document. Omitted material for
which confidential treatment has been requested has been filed separately with the Securities and Exchange Commission.
Portions of this exhibit, marked by brackets and
asterisks, have been omitted pursuant to Item 601(b)(10) of Regulation S-K under the Securities Act of 1933, as amended, because they
are both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed. The registrant undertakes
to promptly provide an unredacted copy of the exhibit on a supplemental basis, if requested by the Commission or its staff.
*
This certification is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.
74
SIGNATURES
Pursuant to the requirements
of Section 13 or 15(d) 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.
XENETIC BIOSCIENCES, INC.
Date: March 22 , 2023
By:
/s/ JEFFREY F. EISENBERG
Jeffrey F. Eisenberg
Chief Executive Officer
POWER OF ATTORNEY AND SIGNATURES
We, the undersigned officers
and directors of Xenetic Biosciences, Inc., hereby severally constitute and appoint Jeffrey F. Eisenberg, our true and lawful attorney,
with full power to him, to sign for us in our names in the capacities indicated below, all amendments to this report, and generally to
do all things in our names and on our behalf in such capacities to enable Xenetic Biosciences, Inc. to comply with the provisions of the
Securities Exchange Act of 1934, as amended, and all requirements of the Securities and Exchange Commission.
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 and in
the capacities indicated below on the 22nd day of March, 2023.
Signature
Title(s)
/s/ JEFFREY F. EISENBERG
Chief Executive Officer and Director
( Principal Executive Officer)
Jeffrey F. Eisenberg
Date: March 22 , 2023
/s/ JAMES PARSLOW
Chief Financial Officer
James Parslow
(Principal Financial Officer and Principal Accounting Officer )
Date: March 22 ,
2023
/s/ GRIGORY BORISENKO
Director
Grigory Borisenko
Date: March 22 ,
2023
/s/ JAMES CALLAWAY
Director
James Callaway
Date: March 22 , 2023
/s/ FIRDAUS JAL DASTOOR
Director
Firdaus Jal Dastoor
Date: March 22, 2023
/s/ ROGER KORNBERG
Director
Roger Kornberg
Date: March 22, 2023
/s/ ADAM LOGAL
Director
Adam Logal
Date: March 22 , 2023
/s/ ALEXEY VINOGRADOV
Director
Alexey Vinogradov
Date: March 22 , 2023
75