Item 9A. Controls and Procedures
Item 9A. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
As of December 31, 2023, management, including our Chief Executive Officer and Chief Financial Officer, evaluated our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act. Our disclosure controls and procedures are designed to ensure that information required to be disclosed in the reports 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 Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2023, the design and operation of our disclosure controls and procedures were effective at a reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
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 designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of consolidated financial statements for external purposes in accordance with GAAP. Because of its inherent limitations, our 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 applicable policies or procedures may deteriorate.
Management has assessed the effectiveness of our internal control over financial reporting based on the framework set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework. Based on our evaluation, management has concluded that our internal control over financial reporting was effective as of December 31, 2023. Management reviewed the results of this assessment with our audit committee.
Attestation Report of the Registered Public Accounting Firm
This Annual Report does not include an attestation report of our registered public accounting firm due to an exemption established by the JOBS Act for “emerging growth companies.”
Changes in Internal Control Over Financial Reporting
There has been no change in our internal control over financial reporting during the year ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information.
Securities Trading Plans of Directors and Executive Officers
During our last fiscal quarter, the following officer, as defined in Rule 16a-1(f), adopted a “Rule 10b5-1 trading arrangement” as defined in Regulation S-K Item 408, as follows:
On December 26, 2023 , Christian Hordo , our Chief Business Officer , terminated a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 600,000 shares of our common stock. The trading arrangement was intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement was until May 31, 2024 , or earlier if all transactions under the trading arrangement were completed. On December 26, 2023 , Mr. Hordo adopted a Rule 10b5-1 trading arrangement providing for the sale from time to time of an aggregate of up to 375,000 shares of our common stock. The trading arrangement is intended to satisfy the affirmative defense in Rule 10b5-1(c). The duration of the trading arrangement is until February 28, 2025 , or earlier if all transactions under the trading arrangement are completed.
188
No other officers or directors, as defined in Rule 16a-1(f), adopted and/or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as defined in Regulation S-K Item 408, during the last fiscal quarter.
Item 9C. Disclosure Regarding Foreign J urisdictions that Prevent Inspections .
Not applicable.
189
PART III
Item 10. Directors, Executive Off icers and Corporate Governance.
The information required by this item is incorporated by reference from the information in our Proxy Statement, which will be filed not later than 120 days after December 31, 2023, in the sections titled “Information About Our Board of Directors,” “Information About Our Executive Officers Who Are Not Directors,” and “Corporate Governance.”
Item 11. Executiv e Compensation.
The information required by this item is incorporated by reference from the information in our Proxy Statement, which will be filed not later than 120 days after December 31, 2023, in the sections titled “Executive Compensation,” “Director Compensation,” and “Corporate Governance – Committees of the Board of Directors – Compensation Committee Interlocks and Insider Participation.”
Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters.
The information required by this item is incorporated by reference from the information in our Proxy Statement, which will be filed not later than 120 days after December 31, 2023, in the sections titled “Securities Authorized For Issuance Under Equity Compensation Plans” and “Security Ownership of Certain Beneficial Owners and Management.”
Item 13. Certain Relationships and Related Transactions, and Director Independence.
The information required by this item is incorporated by reference from the information in our Proxy Statement, which will be filed not later than 120 days after December 31, 2023, in the sections titled “Corporate Governance – Board of Directors Independence” and “Transactions With Related Persons.”
Item 14. Principal Accoun tant Fees and Services.
The information required by this item is incorporated by reference from the information in our Proxy Statement, which will be filed not later than 120 days after December 31, 2023, in the sections titled “Independent Registered Public Accounting Firm Fees and Services” and “Pre-Approval Policies and Procedures.”
190
PART IV
Item 15. Exhibits and Financi al Statement Schedules.
Exhibit Index
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
3.1
Amended and Restated Certificate of Incorporation
8-K
02/09/2021
3.1
3.2
Amended and Restated Bylaws
8-K
02/09/2021
3.2
4.1
Reference is made to Exhibits 3.1 through 3.2
4.2
Form of Common Stock Certificate
S-1/A
01/28/2021
4.2
4.3
Description of Securities Registered Pursuant to Section 12 of the Securities and Exchange Act of 1934, as amended
10-K
03/24/2021
4.3
4.4
Form of Pre-Funded Warrant
8-K
02/08/2024
4.1
10.1
Amended and Restated Investors’ Rights Agreement, by and among the Company and the investors listed therein, dated as of February 13, 2019
S-1
01/13/2021
10.1
10.2
Form of Indemnification and Advancement Agreement for directors and officers
S-1/A
01/28/2021
10.2
10.3(a)#
2018 Equity Incentive Plan, as amended
10-Q
11/08/2021
10.3(a)
10.3(b)#
Second Amendment to 2018 Equity Incentive Plan, dated as of November 9, 2020
S-1
01/13/2021
10.3(b)
10.3(c)#
Third Amendment to 2018 Equity Incentive Plan, dated as of December 4, 2020
S-1
01/13/2021
10.3(c)
10.3(d)#
Fourth Amendment to 2018 Equity Incentive Plan, dated as of December 8, 2021
10-K
03/16/2022
10.3(d)
10.3(e)#
Form of Stock Option Grant Notice and Stock Option Agreement under 2018 Equity Incentive Plan
S-1
01/13/2021
10.3(d)
10.4(a)#
2021 Incentive Award Plan
S-1/A
01/28/2021
10.4(a)
10.4(b)#
First Amendment to 2021 Incentive Award Plan, dated as of December 8, 2021
10-K
03/16/2022
10.4(b)
10.4(c)#
Form of Stock Option Grant Notice and Stock Option Agreement under the 2021 Incentive Award Plan
S-1/A
01/28/2021
10.4(b)
10.4(d)#
Form of Stock Option Grant Notice and Stock Option Agreement under the 2021 Incentive Award Plan
10-K
03/16/2022
10.4(d)
10.4(e)#
Form of Restricted Stock Award Grant Notice and Restricted Stock Award Agreement under the 2021 Incentive Award Plan
S-1/A
01/28/2021
10.4(c)
10.4(f)#
Form of Restricted Stock Unit Award Grant Notice and Restricted Stock Unit Award Agreement under the 2021 Incentive Award Plan
S-1/A
01/28/2021
10.4(d)
10.5#
2021 Employee Stock Purchase Plan
S-1/A
01/28/2021
10.5
10.6#
Amendment No. 1 to the 2021 Employee Stock Purchase Plan, dated as of October 27, 2022
10-Q
11/02/2022
10.11
191
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.7#
Offer Letter and Employment Agreement by and between the Company and Steven D. Harr, M.D., dated as of September 27, 2018
S-1
01/13/2021
10.6
10.8#
Offer Letter and Employment Agreement by and between the Company and Richard Mulligan, Ph.D., dated as of April 23, 2020
S-1
01/13/2021
10.7
10.9#
Offer Letter and Employment Agreement by and between the Company and Christian Hordo, dated as of November 10, 2018
S-1
01/13/2021
10.8
10.10#
Offer Letter and Employment Agreement by and between the Company and Nathan Hardy, dated as of October 8, 2018
S-1
01/13/2021
10.9
10.11#
Offer Letter by and between the Company and Bernard Cassidy, dated as of September 8, 2022
10-Q
11/02/2022
10.10
10.12#
Non-Employee Director Compensation Program
10-K
03/16/2023
10.12
10.13#
Offer Letter by and between the Company and Douglas E. Williams, dated as of April 8, 2023
10-Q
05/08/2023
10.2
10.14(a)
License Agreement by and between Flagship Pioneering Innovations V, Inc. (Flagship Innovations V) and Cobalt Biomedicine, Inc. (Cobalt), dated as of February 17, 2016
S-1
01/13/2021
10.12(a)
10.14(b)
First Amendment to License Agreement by and between Flagship Innovations V and Cobalt, dated as of February 14, 2019
S-1
01/13/2021
10.12(b)
10.15(a)
Patents Sub-License Agreement by and between La Societe Pulsalys (Pulsalys) and Cobalt, dated as of August 16, 2018
S-1
01/13/2021
10.13(a)
10.15(b)
Amendment No. 1 to Patents Sub-License Agreement by and between the Company, Pulsalys and Cobalt, dated as of May 26, 2020
S-1
01/13/2021
10.13(b)
10.15(c)
Amendment No. 2 to Patents Sub-License Agreement by and between the Company and Pulsalys, dated as of March 9, 2022
10-Q
11/02/2022
10.1
10.15(d)
Amendment No. 3 to Patents Sub-License Agreement by and between the Company and Pulsalys, dated as of July 31, 2023
10-Q
11/08/2023
10.1
10.16(a)
Exclusive License Agreement by and between the Company and The Regents of the University of California (The Regents) acting through The Technology Development Group of the University of California, Los Angeles (UCLA), dated as of March 22, 2019
S-1
01/13/2021
10.14
10.16(b)
First Amendment to Exclusive License Agreement by and between the Company and The Regents acting through The Technology Development Group of UCLA, dated as of May 21, 2021
X
10.17(a)
License Agreement by and between the Company and President and Fellows of Harvard College (Harvard), dated as of March 19, 2019
S-1
01/13/2021
10.15(a)
10.17(b)
Amendment to License Agreement by and between the Company and Harvard, dated as of June 10, 2019
S-1
01/13/2021
10.15(b)
10.17(c)
Second Amendment to License Agreement by and between the Company and Harvard, dated as of December 15, 2020
S-1
01/13/2021
10.15(c)
192
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.17(d)
Third Amendment to License Agreement by and between the Company and Harvard, dated as of May 20, 2021
10-K
03/16/2022
10.15(d)
10.17(e)
Fourth Amendment to License Agreement by and between the Company and Harvard, dated as of October 25, 2021
10-K
03/16/2022
10.15(e)
10.17(f)
Fifth Amendment to License Agreement by and between the Company and Harvard, dated as of February 9, 2023
10-K
03/16/2023
10.16(f)
10.18(a)
Exclusive License Agreement by and between the Company and The Regents, acting through its Office of Technology Management, University of California San Francisco (UCSF), dated as of January 2, 2019
S-1
01/13/2021
10.16(a)
10.18(b)
Amendment No. 1 to Exclusive License Agreement by and between the Company and UCSF, dated as of December 3, 2020
S-1
01/13/2021
10.16(b)
10.19
Exclusive License Agreement by and between the Company and Washington University, dated as of November 14, 2019
S-1
01/13/2021
10.17
10.20
Exclusive License Agreement by and between the Company and Washington University, dated as of September 1, 2020
S-1
01/13/2021
10.18
10.21(a)
Amended and Restated Exclusive Patent License Agreement by and among the Company, Oscine Corp., and University of Rochester (Rochester), dated as of September 10, 2020
S-1
01/13/2021
10.19
10.21(b)
Amendment No. 1 to Amended and Restated Exclusive Patent License Agreement by and between the Company and Rochester, dated as of December 30, 2022
X
10.22#
Offer Letter and Employment Agreement by and between the Company and Sunil Agarwal, M.D., dated as of May 20, 2019
S-1
01/13/2021
10.22
10.23#
Transition Agreement and Release by and between the Company and Sunil Agarwal, dated as of April 28, 2023
10-Q
05/08/2023
10.3
10.24#
Consulting Agreement by and between the Company and Sunil Agarwal, dated as of April 29, 2023
10-Q
05/08/2023
10.4
10.25(a)
Option and License Agreement by and between the Company and Beam Therapeutics Inc. (Beam), dated as of October 15, 2021
10-Q
11/08/2021
10.1
10.25(b)
Amendment No. 1 to Option and License Agreement by and between the Company and Beam, dated as of June 6, 2022
10-Q
08/04/2022
10.2
10.25(c)
Amendment No. 2 to Option and License Agreement by and between the Company and Beam, dated as of July 19, 2022
10-Q
11/02/2022
10.2
10.25(d)
Amendment No. 3 to Option and License Agreement by and between the Company and Beam, dated as of March 17, 2023
10-Q
05/08/2023
10.1
10.26
Patent License Agreement by and between the Company and the U.S. Department of Health and Human Services, as represented by The National Cancer Institution, an institute of the National Institutes of Health, dated as of January 7, 2022
10-K
03/16/2022
10.25
10.27
Lease Agreement by and between the Company and ARE-Seattle No. 39, LLC, dated as of June 1, 2022
10-Q
08/04/2022
10.1
193
Incorporated by Reference
Exhibit
Number
Exhibit Description
Form
Date
Number
Filed
Herewith
10.28
Sales Agreement by and between the Company and Cowen and Company, LLC, dated as of August 4, 2022
S-3
08/04/2022
1.2
10.29#
Change in Control Severance Plan and Summary Plan Description
X
21.1
List of Subsidiaries
10-K
03/24/2021
21.1
23.1
Consent of Independent Registered Public Accounting Firm
X
24.1
Power of Attorney (reference is made to the signature page)
X
31.1
Certificate of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
31.2
Certificate of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
X
32.1*
Certificate of Principal Executive Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2*
Certificate of Principal Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
97.1
Compensation Recovery Policy
X
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
# Indicates management contract or compensatory plan.
Certain portions of this document that constitute confidential information have been redacted in accordance with Regulation S-K Item 601(b)(10).
* These certifications are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of the Company 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.
Item 16. Form 10-K Summary
Not applicable.
194
SIGNAT URES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange 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 in the City of Seattle, State of Washington on the 29 th day of February 2024 .
SANA BIOTECHNOLOGY, INC.
/s/ Steven D. Harr, M.D.
Name:
Steven D. Harr, M.D.
Title:
President and Chief Executive Officer
(Principal Executive Officer)
/s/ Nathan Hardy
Name:
Nathan Hardy
Title:
Chief Financial Officer
(Principal Financial and Accounting Officer)
195
POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints Steven D. Harr, M.D., Nathan Hardy, and Bernard J. Cassidy and each of them, with full power of substitution and resubstitution and full power to act without the other, as his or her true and lawful attorney-in-fact and agent to act in his or her name, place and stead and to execute in the name and on behalf of each person, individually and in each capacity stated below, and to file 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, ratifying and confirming all that said attorneys-in-fact and agents or any of them or their or his 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, 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/ Steven D. Harr, M.D.
President, Chief Executive Officer and Director (Principal Executive Officer)
February 29, 2024
Steven D. Harr, M.D.
/s/ Nathan Hardy
Chief Financial Officer (Principal Financial and Accounting Officer)
February 29, 2024
Nathan Hardy
/s/ Hans E. Bishop
Chairman of the Board
February 29, 2024
Hans E. Bishop
/s/ Joshua H. Bilenker, M.D.
Director
February 29, 2024
Joshua H. Bilenker, M.D.
/s/ Douglas Cole, M.D.
Director
February 29, 2024
Douglas Cole, M.D.
/s/ Richard Mulligan, Ph.D.
Director
February 29, 2024
Richard Mulligan, Ph.D.
/s/ Robert Nelsen
Director
February 29, 2024
Robert Nelsen
/s/ Alise S. Reicin, M.D.
Director
February 29, 2024
Alise S. Reicin, M.D.
/s/ Michelle Seitz
Director
February 29, 2024
Michelle Seitz
/s/ Mary Agnes (Maggie) Wilderotter
Director
February 29, 2024
Mary Agnes (Maggie) Wilderotter
/s/ Patrick Y. Yang, Ph.D.
Director
February 29, 2024
Patrick Y. Yang, Ph.D.
196