Humacyte, Inc. 10-K

Item 9A. Controls and Procedures Evaluation of Disclosure Controls and Procedures Disclosure controls and procedures are designed to ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is (i) recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. As of December 31, 2023, our management, under the supervision and 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 Exchange Act). Based on that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2023. Management’s Report on Internal Control Over Financial Reporting Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as defined in Rule 13a-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the financial statements for external purposes in accordance with U.S. GAAP. A control system, no matter how well designed and operated, can only provide reasonable, not absolute, assurance that the objectives of the control system are met. Because of these inherent limitations, management does not expect that our internal controls over financial reporting will prevent all errors and all fraud. 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 our policies and procedures may deteriorate. Our management, under the supervision of and with the participation of our Chief Executive Officer and Chief Financial Officer, conducted an evaluation of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework issued in 2013 by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the results of its evaluation, management concluded that our internal control over financial reporting was effective as of December 31, 2023. Attestation Report of the Registered Public Accounting Firm This Annual Report on Form 10-K does not include an attestation report of our independent registered public accounting firm regarding internal control over financial reporting as we are an “emerging growth company” as defined in the JOBS Act. For as long as we remain an “emerging growth company,” we are exempt from the auditor attestation requirement in the assessment of the effectiveness of our internal control over financial reporting. Changes in Internal Control Over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Item 9B. Other Information Director and Officer Trading Arrangements During the three months ended December 31, 2023, no director or officer (as defined in Rule 16a-1(f) under the Exchange Act) of the Company adopted or terminated any “Rule 10b5-1 trading arrangement” or any “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 None. 144 Table of Contents Part III Item 10. Directors, Executive Officers and Corporate Governance. Incorporated by reference from the information in our Proxy Statement for our 2024 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates. Item 11. Executive Compensation. Incorporated by reference from the information in our Proxy Statement for our 2024 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates. Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters. Incorporated by reference from the information in our Proxy Statement for our 2024 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates. Item 13. Certain Relationships and Related Transactions, and Director Independence Incorporated by reference from the information in our Proxy Statement for our 2024 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates. Item 14. Principal Accountant Fees and Services Incorporated by reference from the information in our Proxy Statement for our 2024 Annual Meeting of Stockholders, which we will file with the SEC within 120 days of the end of the fiscal year to which this Annual Report on Form 10-K relates. 145 Table of Contents Part IV Item 15. Exhibits and Financial Statement Schedules. (a) The following financial statements are included in this Annual Report on Form 10-K: (1) List of Financial Statements: The financial statements required by this item are listed in Item 8, “Financial Statements and Supplementary Data” herein. (2) List of Financial Statement Schedules: All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or notes thereto. (3) List of Exhibits: Exhibit No. Description 3.1 Second Amended and Restated Certificate of Incorporation of Humacyte, Inc. (incorporated by reference to Exhibit 3.1 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 3.2 Amended and Restated By Laws of Humacyte, Inc. (incorporated by reference to Exhibit 3.2 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on December 12, 2022). 4.1 Warrant Agreement, dated September 17, 2020, by and between Alpha Healthcare Acquisition Corp. and Continental Stock Transfer & Trust Company, as warrant agent (incorporated by reference to Exhibit 4.1 to Alpha Healthcare Acquisition Corp.’s Annual Report on Form 10–K/A, filed with the SEC on May 14, 2021). 4.2 Form of Subscription Agreement (incorporated by reference to Exhibit 10.3 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on August 2, 2021). 4.3* Form of Investor Rights and Lock–up Agreement (incorporated by reference to Exhibit A of Annex A to the proxy statement/prospectus contained in Humacyte, Inc.'s Registration Statement on S-4/A, filed with the SEC on August 2, 2021). 4.4 Warrant to Purchase Common Stock, dated March 30, 2021 (incorporated by reference to Exhibit 10.6.1 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 4.5 Warrant to Purchase Common Stock, dated March 30, 2021 (incorporated by reference to Exhibit 10.6.2 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 4.6! Description of the Company’s securities registered pursuant to Section 12 of the Securities Exchange Act of 1934, as amended. 10.1.1 Revenue Interest Purchase Agreement, dated as of May 12, 2023, by and among Humacyte Global, Inc., Humacyte, Inc. and Hook SA LLC. (incorporated by reference to Exhibit 10.1 to Humacyte, Inc.’s Quarterly Report on Form 10-Q filed with the SEC on August 14, 2023). 10.1.2!* Waiver, dated as of February 18, 2024, by and among Humacyte Global, Inc., Humacyte, Inc. and Hook SA LLC. 10.2 Option Agreement, dated as of May 12, 2023, by and among Humacyte, Inc., TPC Investments III LP and TPC Investments Solutions LP. (incorporated by reference to Exhibit 4.1 to Humacyte, Inc.’s Registration Statement on Form S-3, filed with the SEC on June 9, 2023). 10.3 Open Market Sale Agreement, dated September 1, 2022, by and between Humacyte, Inc. and Jefferies LLC, (incorporated by reference to Exhibit 1.2 to Humacyte, Inc.’s Registration Statement on Form S-3 (File No. 333-267225), filed with the SEC on September 1, 2022). 10.4˄ Distribution Agreement, dated June 25, 2018, by and between Fresenius Medical Care Holdings, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.6 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.4.1˄ First Amendment to Distribution Agreement, dated October 2, 2019, by and between Fresenius Medical Care Holdings, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.6.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.4.2˄ Second Amendment to Distribution Agreement, effective as of February 16, 2021, by and between Fresenius Medical Care Holdings, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.6.2 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 146 Table of Contents Exhibit No. Description 10.5˄ Exclusive License Agreement, dated February 25, 2014, by and between Yale University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.8 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 10.6˄ Exclusive License Agreement, dated August 13, 2019, by and between Yale University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.9 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 10.7˄ Exclusive License Agreement, dated August 25, 2019, by and between Yale University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 10.8˄ Exclusive Patent License Agreement, dated March 14, 2006, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.1˄ First Amendment to Exclusive Patent License Agreement, dated February 25, 2011, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.2˄ Second Amendment to Exclusive Patent License Agreement, dated April 24, 2014, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10.2 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.3˄ Third Amendment to Exclusive Patent License Agreement, dated June 26, 2015, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10.3 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.4˄ Fourth Amendment to Exclusive Patent License Agreement, dated January 2, 2018, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10.4 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.5˄ Fifth Amendment to Exclusive Patent License Agreement, dated December 31, 2019, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.10.5 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.8.6^ Sixth Amendment to Exclusive Patent License Agreement, dated January 10, 2022, between Duke University and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.7.6 to Humacyte, Inc.’s Annual Report on Form 10-K filed with the SEC on March 29, 2022). 10.9˄ Supply Agreement, dated January 9, 2014, between SeraCare Life Sciences, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.11 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.9.1˄ First Amendment to Supply Agreement, dated October 12, 2018, between SeraCare Life Sciences, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.11.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.9.2˄ * Second Amendment to Supply Agreement, dated March 24, 2021, between SeraCare Life Sciences, Inc. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.12.2 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 10.10˄ * Supply Agreement, dated June 1, 2020, between Confluent Medical Technologies and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.13 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on June 14, 2021). 10.11+* Executive Employment Agreement, dated February 3, 2021, between Laura Niklason, M.D., Ph.D. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.13 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.12+ Executive Employment Agreement, dated May 18, 2021, between Dale Sander and Humacyte, Inc. (incorporated by reference to Exhibit 10.11 to Humacyte, Inc.’s Annual Report on Form 10-K, filed with the SEC on March 24, 2023). 10.13+ Executive Employment Agreement, dated September 13, 2019 between Heather Prichard, Ph.D. and Humacyte Global, Inc. (incorporated by reference to Exhibit 10.16 to Humacyte, Inc.'s Registration Statement on S-4, filed with the SEC on March 23, 2021). 10.14+ Humacyte, Inc. 2021 Long–Term Incentive Plan (incorporated by reference to Exhibit 10.4 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 10.14.1+ Form of Stock Option Agreement under Humacyte, Inc. 2021 Long–Term Incentive Plan (incorporated by reference to Exhibit 10.4.1 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 10.15+ Humacyte, Inc. 2021 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.5 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 10.16+ Humacyte, Inc. Annual Bonus Plan (incorporated by reference to Exhibit 10.8 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 147 Table of Contents Exhibit No. Description 10.17+ Humacyte, Inc. 2005 Stock Option Plan (incorporated by reference to Exhibit 10.18 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.17.1+ First Amendment of Humacyte, Inc. 2005 Stock Option Plan, dated March 31, 2008 (incorporated by reference to Exhibit 10.18.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.17.2+ Second Amendment of Humacyte, Inc. 2005 Stock Option Plan, dated October 28, 2011 (incorporated by reference to Exhibit 10.18.2 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.17.3+ Third Amendment of Humacyte, Inc. 2005 Stock Option Plan, dated November 22, 2013 (incorporated by reference to Exhibit 10.18.3 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.17.4+ Form of Incentive Stock Option Agreement under Humacyte, Inc. 2005 Stock Option Plan (incorporated by reference to Exhibit 10.18.4 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.17.5+ Form of Nonqualified Stock Option Agreement under Humacyte, Inc. 2005 Stock Option Plan (incorporated by reference to Exhibit 10.18.5 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.18+ Humacyte, Inc. 2015 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.19 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.18.1+ First Amendment to Humacyte, Inc. 2015 Omnibus Incentive Plan, dated February 23, 2018 (incorporated by reference to Exhibit 10.19.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.18.2+ Second Amendment to Humacyte, Inc. 2015 Omnibus Incentive Plan, dated June 6, 2018 (incorporated by reference to Exhibit 10.19.2 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.18.3+ Form of Incentive Stock Option Agreement under Humacyte, Inc. 2015 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.19.3 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.18.4+ Form of Nonqualified Stock Option Agreement under Humacyte, Inc. 2015 Omnibus Incentive Plan (incorporated by reference to Exhibit 10.19.4 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.19+ Form of Indemnity Agreement by and between Humacyte, Inc. and each of its directors and executive officers (incorporated by reference to Exhibit 10.23 to Humacyte, Inc.’s Registration Statement on S–4/A, filed with the SEC on July 1, 2021). 10.20 Lease Agreement, dated December 31, 2015, between ARE–NC Region No. 5, LLC and Humacyte, Inc. (incorporated by reference to Exhibit 10.22 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.20.1 First Amendment to Lease, dated September 30, 2016, between ARE–NC Region No. 5, LLC and Humacyte, Inc. (incorporated by reference to Exhibit 10.22.1 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.20.2 Second Amendment to Lease, dated February 8, 2017, between ARE–NC Region No. 5, LLC and Humacyte, Inc. (incorporated by reference to Exhibit 10.22.2 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.20.3 Third Amendment to Lease, dated April 21, 2017, between ARE–NC Region No. 5, LLC and Humacyte, Inc. (incorporated by reference to Exhibit 10.22.3 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 10.20.4 Fourth Amendment to Lease, dated October 31, 2017, between ARE–NC Region No. 5, LLC and Humacyte, Inc. (incorporated by reference to Exhibit 10.22.4 to Humacyte, Inc.’s Registration Statement on S–4, filed with the SEC on March 23, 2021). 21.1 Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to Humacyte, Inc.’s Current Report on Form 8–K, filed with the SEC on August 27, 2021). 23.1! Consent of PricewaterhouseCoopers LLP. 31.1! Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 31.2! Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. 32.1! Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 148 Table of Contents Exhibit No. Description 32.2! Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 97+! Humacyte, Inc. Compensation Clawback Policy. 101! The following materials from Humacyte, Inc.’s Annual Report on Form 10-K for the year ended December 31, 2023, formatted in Inline XBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of December 31, 2023 and 2022, (ii) Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022, (iii) Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023 and 2022, (iv) Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022, and (v) Notes to Consolidated Financial Statements. 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). ___________________________ ! Filed herewith. * Annexes, schedules and exhibits have been omitted pursuant to Item 601(b)(2) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the Securities and Exchange Commission on a confidential basis upon request. ^ Certain confidential information contained in this exhibit, market by brackets, has been omitted because the information (i) is not material and (ii) is the type of information the company both customarily and actually treats as private or confidential. + Management contract or compensatory plan or arrangement. Item 16. Form 10-K Summary. None. 149 Table of Contents 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. HUMACYTE, INC. By: /s/ Laura E. Niklason Name: Laura E. Niklason, M.D., Ph.D. Title: President and Chief Executive Officer Date: March 28, 2024 Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Annual Report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated: Name Position Date /s/ Laura E. Niklason President, Chief Executive Officer and Director (Principal Executive Officer) March 28, 2024 Laura E. Niklason, M.D., Ph.D. /s/ Dale A. Sander Chief Financial Officer, Chief Corporate Development Officer and Treasurer (Principal Financial and Accounting Officer) March 28, 2024 Dale A. Sander /s/ Kathleen Sebelius Director March 28, 2024 Kathleen Sebelius /s/ Gordon M. Binder Director March 28, 2024 Gordon M. Binder Director March 28, 2024 Emery N. Brown, M.D., Ph.D. /s/ Michael T. Constantino Director March 28, 2024 Michael T. Constantino /s/ Brady W. Dougan Director March 28, 2024 Brady W. Dougan /s/ C. Bruce Green Director March 28, 2024 C. Bruce Green, M.D. /s/ Todd M. Pope Director March 28, 2024 Todd M. Pope /s/ Diane Seimetz Director March 28, 2024 Diane Seimetz, Ph.D. /s/ Rajiv Shukla Director March 28, 2024 Rajiv Shukla /s/ Max Wallace Director March 28, 2024 Max Wallace, J.D. /s/ Susan Windham-Bannister Director March 28, 2024 Susan Windham-Bannister, Ph.D. 150