Xenetic Biosciences, Inc. 10-K

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, 2023, 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. 64 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 During the quarter ended December 31, 2023, no director or officer adopted or terminated any Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement, as each term is defined in Item 408(a) of Regulation S-K. ITEM 9C – DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS Not applicable. 65 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 2024 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year ended December 31, 2023 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 2024 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year ended December 31, 2023 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 2024 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year ended December 31, 2023 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 2024 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year ended December 31, 2023 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 2024 Annual Meeting of Stockholders within 120 days of the end of the Company’s fiscal year ended December 31, 2023 and is incorporated herein by reference, or will be included in an amendment to this Annual Report on Form 10-K. 66 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 67 which is incorporated herein by reference. ITEM 16 – FORM 10-K SUMMARY Not applicable. 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 10-K 03/22/2023 3.14 3.15 Certificate of Change to Articles of Incorporation 8-K 05/12/2023 3.1 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 Form of Common Stock Purchase Warrant 8-K 06/25/2019 4.1 4.4 Form of Common Stock Purchase Warrant 8-K 07/22/2019 4.2 4.5 Form of Series A Warrant 8-K 07/28/2021 4.1 67 Exhibit No. Exhibit Index Form Filing Date Exhibit Number Filed Herewith 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 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 January 1, 2017 between Xenetic Biosciences, Inc. and Curtis Lockshin 8-K 01/04/2017 10.1 10.10† Employment Agreement, dated March 23, 2017 between Xenetic Biosciences, Inc. and James F. Parslow 8-K 04/04/2017 10.1 10.11† 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 10.12† Amended and Restated Employment Agreement, dated October 26, 2017, between Xenetic Biosciences, Inc. and Jeffrey Eisenberg 10-K 03/30/2018 10.45 10.13# 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 10.14 Assignment Agreement between Xenetic Biosciences, Inc. and OPKO Pharmaceuticals, LLC, dated March 1, 2019 8-K/A 05/20/2019 10.1 10.15 First Amendment to Assignment Agreement dated June 7, 2019 8-K 06/13/2019 10.1 10.16 Second Amendment to Assignment Agreement dated June 24, 2019 8-K 06/24/2019 10.1 10.17 Third Amendment to Assignment Agreement dated July 15, 2019 8-K 07/16/2019 10.1 10.18 Form of Consent Agreement by and among Xenetic Biosciences, Inc. and certain purchasers dated June 24, 2019 8-K 06/25/2019 10.1 10.19 Warrant Agency Agreement, between Xenetic Biosciences, Inc. and Empire Stock Transfer, Inc. dated July 19, 2019 8-K 07/22/2019 10.1 10.20 Consent Agreement by and among Xenetic Biosciences, Inc. and certain purchasers dated July 16, 2019 8-K 07/16/2019 10.1 10.21† Form of Letter Agreement re. Appointment of Non – Employee, Independent Director of Xenetic Biosciences, Inc. 10-K 03/26/2020 10.51 10.22† Form of Xenetic Biosciences, Inc. Stock Option Grant Notice 10-K 03/26/2020 10.52 10.23† 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 68 Exhibit No. Exhibit Index Form Filing Date Exhibit Number Filed Herewith 10.24 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 10.25 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 10.26## Exclusive Sublicense Agreement, dated April 26, 2022, between Xenetic Biosciences, Inc. and CLS Therapeutics LTD 10-Q 8/11/2022 10.1 10.27## Exclusive License Agreement, dated April 26, 2022, between Xenetic Biosciences, Inc. and CLS Therapeutics LTD 10-Q 8/11/2022 10.2 10.28 Form of Subscription Agreement, dated April 26, 2022, between Xenetic Biosciences, Inc. and CLS Therapeutics LTD 10-Q 8/11/2022 10.3 10.29## Statement of Work, dated June 30, 2022, between Xenetic Biosciences, Inc. and Catalent Pharma Solutions, LLC 10-Q 8/11/2022 10.4 10.30## Research Funding and Option Agreement, dated March 17, 2023, between the Company and the Scripps Research Institute 10-Q 5/11/2023 10.1 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 97.1 Policy Regarding the Mandatory Recovery of Compensation 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. 69 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 21, 2024 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 21st day of March, 2024. Signature Title(s) /s/ JEFFREY F. EISENBERG Chief Executive Officer and Director ( Principal Executive Officer) Jeffrey F. Eisenberg Date: March 21, 2024 /s/ JAMES PARSLOW Chief Financial Officer James Parslow (Principal Financial Officer and Principal Accounting Officer ) Date: March 21, 2024 /s/ GRIGORY BORISENKO Director Grigory Borisenko Date: March 21, 2024 /s/ JAMES CALLAWAY Director James Callaway Date: March 21, 2024 /s/ FIRDAUS JAL DASTOOR Director Firdaus Jal Dastoor Date: March 21, 2024 /s/ Dmitry Genkin Director Dmitry Genkin Date: March 21, 2024 /s/ ROGER KORNBERG Director Roger Kornberg Date: March 21, 2024 /s/ ADAM LOGAL Director Adam Logal Date: March 21, 2024 Director Moshe Mizrahy Date: March 21, 2024 /s/ ALEXEY VINOGRADOV Director Alexey Vinogradov Date: March 21, 2024 70