Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of December 31, 2021, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. GAAP. Our internal control over financial reporting includes those policies and procedures that:
•
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect our transactions and dispositions of our assets;
•
provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with U.S. GAAP, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and
•
provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our 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.
Our management, with the participation of our principal executive officer and principal financial officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2021. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in its 2013 Internal Control – Integrated Framework. Based on our assessment, our management has concluded that, as of December 31, 2021, our internal control over financial reporting is effective based on those criteria.
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This Annual Report on Form 10-K does not include an attestation report of our registered public accounting firm regarding internal control over financial reporting. For as long as we remain a “ smaller reporting company” as defined by Rule 12b-2 of the Exchange Act and report less than $100 million of annual revenues in our most recent fiscal year , we intend to take advantage of the exemption permitting us not to comply with the requirement that our independent registered public accounting firm provide an attestation on 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 that occurred during the quarter ended December 31, 2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
None.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
None.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2022 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
ITEM 11. EXECUTIVE COMPENSATION
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2022 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by 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 is incorporated herein by reference to our Proxy Statement with respect to our 2022 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2022 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2022 Annual Meeting of Stockholders to be filed with the SEC within 120 days of the end of the fiscal year covered by this Annual Report on Form 10-K.
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PART IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
The following documents are filed as part of this report:
1.
Financial Statements
See Index to Financial Statements at Item 8 herein.
2.
Financial Statement Schedules
All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.
3.
Exhibits
Incorporate by Reference
Exhibit
Date of
Exhibit
Filed
Number
Description of Document
Form
File No.
Filing
No.
Herewith
3.1
Restated Certificate of Incorporation
S-1/A
333-205001
9/14/2015
3.2
3.2
Amended and Restated Bylaws
8-K
001-37722
4/3/2020
3.1
4.1
Form of Common Stock Certificate
S-1/A
333-205001
9/14/2015
4.1
4.2
Form of Pre-Funded Warrants 2019
8-K
001-37722
2/7/2019
4.1
4.3
Description of the Registrant's securities
10-K
001-37722
3/18/2021
4.3
4.4
Form of Pre-Funded Warrants 2020
8-K
001-37722
4/28/2020
4.1
4.5
Registration Rights Agreement, dated March 16, 2021, by and among the Registrant and Baker Brothers Life Sciences, L.P. and 667, L.P.
10-K
001-37722
3/18/2021
4.5
10.1
Form of Amended and Restated Indemnification Agreement
10Q
001-37722
8/9/2018
10.1
10.2‡
2015 Equity Incentive Plan and forms of award agreements
S-1
333-205001
6/16/2015
10.2
10.3‡
2016 Equity Incentive Plan and forms of award agreements, as amended
10Q
001-37722
11/8/2018
10.2
10.4‡
2016 Employee Stock Purchase Plan and forms of award agreements, as amended
10-K
001-37722
3/7/2019
10.4
10.5‡
2018 Equity Inducement Plan
S-8
333-223614
3/13/2018
99.2
10.6‡
Form of Stock Restriction Agreement
S-1
333-205001
6/16/2015
10.5
10.7‡
Form of Severance Agreement
8-K
001-37722
4/16/2018
10.1
10.8†
Sponsored Research Agreement No. UTA13-001113, dated December 24, 2013, between The University of Texas at Austin (“UT-Austin”) and Aeglea BioTherapeutics, Inc., Aeglea Development Company, Inc., AERase, Inc., AEMase, Inc., AECase, Inc., AE4ase, Inc., AE5ase, Inc. and AE6ase., Inc., as amended
10-Q
001-37722
11/7/2017
10.3
116
Incorporate by Reference
Exhibit
Date of
Exhibit
Filed
Number
Description of Document
Form
File No.
Filing
No.
Herewith
10.9
Office Lease, dated November 24, 2014, between Barton Oaks Office Center, LLC and the Registrant
S-1
333-205001
6/16/2015
10.11
10.10
First Amendment to Office Lease and Assignment and Assumption of Lease dated September 20, 2016 to Office Lease dated November 24, 2014, between Barton Oaks Office Center, LLC, Aeglea Development Company, Inc., and Aeglea BioTherapeutics, Inc .
10-Q
001-37722
11/9/2016
10.1
10.11†
Amended and Restated Patent License Agreement No. PM1401501, dated January 31, 2017, between the Registrant and The University of Texas at Austin on behalf of the Board of Regents of the University of Texas system
10-K
001-37722
3/7/2019
10.12
10.12†
Cancer Research Grant Contract, dated June 15, 2015, between AERase, Inc. and the Cancer Prevention Research Institute of Texas
S-1
333-205001
6/16/2015
10.15
10.13‡
Offer Letter, dated July 18, 2018, by and between the Registrant and Anthony G. Quinn
8-K
001-37722
7/23/2018
10.1
10.14‡
Severance Agreement, dated July 18, 2018, by and between the Registrant and Anthony G. Quinn
8-K
001-37722
7/23/2018
10.2
10.15†
Master Services Agreement, dated November 26, 2018, between the Registrant, Fujifilm Diosynth Biotechnologies UK Limited, Fujifilm Diosynth Biotechnologies Texas, LLC, and Fujifilm Diosynth Biotechnologies U.S.A, Inc.
10-K
001-37722
3/9/2019
10.18
10.16
Lease Agreement dated April 30, 2019, between Las Cimas Owner LP and the Registrant
10-Q
001-37722
5/7/2019
10.1
10.17‡
Offer Letter, dated March 13, 2020 issued by the Registrant to Dr. Leslie Sloan
10-Q
001-37722
5/7/2020
10.1
10.18‡
Severance Agreement dated August 7, 2019 by and between the Registrant and Dr. Leslie Sloan
10-Q
001-37722
5/7/2020
10.2
10.19‡
License and Supply Agreement, dated March 21, 2021, by and between the Registrant and Immedica Pharma AB
10-Q
001-37722
5/10/2021
10.1
10.20‡
Offer Letter, dated June 14, 2021 issued by the Registrant to Mr. Jonathan Alspaugh
X
10.21‡
Severance Agreement dated July 6, 2021 by and between the Registrant and Mr. Jonathan Alspaugh
X
21.1
Subsidiaries of the Registrant
X
23.1
Consent of independent registered public accounting firm
X
24.1
Power of Attorney. Reference is made to the signature page hereto
X
117
Incorporate by Reference
Exhibit
Date of
Exhibit
Filed
Number
Description of Document
Form
File No.
Filing
No.
Herewith
31.1
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
X
31.2
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) or 15d-14(a) of the Securities Exchange Act of 1934
X
32.1(1)
Certification of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2(1)
Certification of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
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
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 Labels Linkbase Document
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
104
The cover page of this Annual Report on Form 10-K for the year ended December 31, 2020, formatted in Inline XBRL and contained in Exhibit 1010
†
Confidential treatment has been granted for portions of this exhibit pursuant to Rule 406 of the Securities Act, or Rule 24b-2 of the Exchange Act. The Registrant has omitted and filed separately with the SEC the confidential portions of this exhibit.
‡
Indicates management contract or compensatory plan.
(1)
The certifications on Exhibit 32 hereto are deemed not “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liability of that Section. Such certifications will not be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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 Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 8, 2022
AEGLEA BIOTHERAPEUTICS, INC.
By:
/s/ Anthony G. Quinn, M.B Ch.B, Ph.D.
Anthony G. Quinn, M.B Ch.B, Ph.D.
President, Chief Executive Officer and Director
(Principal Executive Officer)
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Anthony G. Quinn, M.B. Ch.B, Ph.D. and Jonathan Alspaugh, jointly and severally, his attorneys-in-fact, each with the power of substitution, for him in any and all capacities, to sign any amendments to this Report on Form 10-K and to file same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his substitutes, may do or cause to be done by virtue hereof.
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 and on the dates indicated.
Signature
Title
Date
/s/ Anthony G. Quinn, M.B Ch.B, Ph.D.
President, Chief Executive Officer and Director
March 8, 2022
Anthony G. Quinn, M.B. Ch.B, Ph.D.
(Principal Executive Officer)
/s/ Jonathan Alspaugh
Chief Financial Officer
March 8, 2022
Jonathan Alspaugh
(Principal Financial Officer)
/s/ Steven Weber
Vice President and Corporate Controller
March 8, 2022
Steven Weber
(Principal Accounting Officer)
/s/ Russell J. Cox
Director
March 8, 2022
Russell J. Cox
/s/ Sandesh Mahatme, LLM
Director
March 8, 2022
Sandesh Mahatme, LLM
/s/ Armen Shanafelt, Ph.D.
Director
March 8, 2022
Armen Shanafelt, Ph.D.
/s/ Ivana Magovcevic-Liebisch, Ph.D.
Ivana Magovcevic-Liebisch, Ph.D.
Director
March 8, 2022
/s/ Bryan Lawlis, Ph.D.
Bryan Lawlis, Ph.D.
Director
March 8, 2022
/s/ Alison Lawton
Director
March 8, 2022
Alison Lawton
/s/ Marcio Souza, M.B.A.
Director
March 8, 2022
Marcio Souza, M.B.A.
/s/ Hunter C. Smith, M.B.A.
Director
March 8, 2022
Hunter C. Smith, M.B.A.
119