Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures
Under the supervision of and with the participation of our management, including our chief executive officer, who is our principal executive officer, and our chief financial officer, who is our principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of December 31, 2022, the end of the period covered by this Annual Report. The term “disclosure controls and procedures,” as set forth 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 provide reasonable assurance that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the rules and forms promulgated by the SEC. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, 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 management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2022, our chief executive officer and chief financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
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 chief executive officer and chief financial officer 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. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. 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. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions
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about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Our management, with the participation of our chief executive officer and chief financial officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2022. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in its Internal Control – Integrated Framework (2013) . Based on our assessment, our management has concluded that, as of December 31, 2022, our internal control over financial reporting is effective based on those criteria.
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. For as long as we remain an “emerging growth company” as defined in Section 2(a) of the Securities Act of 1933, or the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012, 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 identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
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Item 9B. Other Information
None.
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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 2023 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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Item 11. Executive Compensation
The information required by this item is incorporated herein by reference to our Proxy Statement with respect to our 2023 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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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 2023 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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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 2023 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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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 2023 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
(1) Financial Statements:
The financial statements required by Item 15(a) are filed as part of this Annual Report on Form 10-K under Item 8 “Financial Statements and Supplementary Data.”
(2) Financial Statement Schedules
The financial statement schedules required by Item 15(a) are omitted because they are not applicable, not required or the required information is included in the financial statements or notes thereto as filed in Item 8 of this Annual Report on Form 10-K.
(3) Exhibits.
Exhibit
Number
Description
Form
File No.
Exhibit
Filing
Date
Filed/
Furnished
Herewith
3.1
Restated Certificate of Incorporation, dated March 3, 2020.
10-Q
001-39231
May 11, 2020
3.2
Amended and Restated Bylaws, dated December 1, 2022.
8-K
001-39231
December 2, 2022
4.1
Form of Common Stock Certificate
S-1/A
333-236214
February 18, 2020
4.2
Amended and Restated Investors' Rights Agreement, dated August 21, 2019, by and among the Registrant and certain of its stockholders.
S-1
333-236214
February 3, 2020
4.3
Description of Registrant’s Securities
10-K
001-39231
March 3, 2021
10.1 †˄
Development Services and Clinical Supply Agreement, dated April 13, 2020, by and between the Registrant and Catalent Maryland, Inc.
10-Q
001-39231
May 11, 2020
10.2
Lease, dated April 10, 2020, by and between the Registrant and Commerce Square Partners - Philadelphia Plaza, L.P.
10-Q
001-39231
May 11, 2020
10.3
First Amendment to Lease, dated April 10, 2020, by and between the Registrant and Philadelphia Plaza – Phase II LP
10-Q
001-39231
May 11, 2020
10.4
Form of Indemnification Agreement between the Registrant and its directors and officers
S-1
333-236214
February 3, 2020
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10.5
Amended and Restated 2018 Equity Incentive Plan, as amended, and forms of award agreements.
S-1
333-236214
February 3, 2020
10.6
2020 Equity Incentive Plan of the Registrant, and forms of award agreements.
S-1/A
333-236214
February 18, 2020
10.7
2020 Employee Stock Purchase Plan of the registrant
S-1/A
333-236214
February 18, 2020
10.8
Amended and Restated Employment Agreement dated February 14, 2020, by and between the Registrant and Bruce Goldsmith.
S-1/A
333-236214
February 18, 2020
10.9
Consulting Agreement, dated January 8, 2019, as amended on January 31, 2020, by and between the Registrant and James Wilson, M.D., Ph.D.
S-1
333-236214
February 3, 2020
10.10 †˄
Amended and Restated Sponsored Research, Collaboration and License Agreement, dated May 5, 2020, by and between the Registrant and The Trustees of the University of Pennsylvania .
10-Q
001-39231
August 13, 2020
10.11 ˄
Amendment No. 1, dated August 13, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-Q
001-39231
November 10, 2020
10.12 ˄
Amendment No. 2, dated November 2, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
S-1
333-252213
January 19, 2021
10.13 †˄
Amendment No. 3, dated December 9, 2020, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
S-1
333-252213
January 19, 2021
10.14˄
Lease, dated December 15, 2020 by and between the Registrant and Hopewell Campus Owner, LLC
8-K
001-39231
December 18, 2020
10.15
2021 Equity Inducement Plan
S-8
333-258000
July 19, 2021
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10.16†˄
Amendment No. 4, dated June 2, 2021, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-K
001-39231
March 3, 2022
10.17
Amendment No. 5, dated August 3, 2021, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-Q
001-39231
November 4, 2021
10.18†˄
Amendment No. 6, dated November 12, 2021, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-K
001-39231
March 3, 2022
10.19†˄
Amendment No. 7, dated December 3, 2021, to the Amended and Restated Sponsored Research, Collaboration and License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
10-K
001-39231
March 3, 2022
10.20†˄
Eighth Amendment to Amended and Restated Research, License & Collaboration Agreement, dated May 11, 2022, by and between the Registrant and the Trustees of the University of Pennsylvania.
10-Q
001-39231
August 4, 2022
10.21+
Employment Agreement, dated August 23, 2021 by and between the Registrant and Simona King.
10-Q
001-39231
November 4, 2021
10.22+†
Employment Agreement, dated October 10, 2022 by and between the Registrant and William Chou.
10-Q
001-39231
November 10, 2022
10.23+†
Transition and Separation Agreement, dated May 27, 2022 by and between the Registrant and Bruce Goldsmith.
10-Q
001-39231
August 4, 2022
10.24+†
Employment Agreement dated September 10, 2019, as amended on February 26 th , 2020, by and between the Registrant and Edgar B. (Chip) Cale.
X
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10.25+†
Employment Agreement, dated July 22, 2019, as amended on February 14, 2022, by and between the Registrant and Alexandros Fotopoulos.
S-1/A
333-236214
February 18, 2020
10.26+†
Transition and Separation Agreement, dated November 17, 2022, by and between the Registrant and Monika Toernsen.
X
23.1
Consent of KPMG LLP, an independent registered public accounting firm.
X
24.1
Power of Attorney. Reference is made to the signature page hereto.
X
31.1
Certification of Principal 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.
X
31.2
Certification of Principal 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.
X
32.1*
Certification of 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*
Certification of 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
X
101.SCH
XBRL Taxonomy Extension Schema Document
X
101.CAL
XBRL Taxonomy Extension Calculation Linkbase Document.
X
101.DEF
XBRL Taxonomy Extension Definition Linkbase Document.
X
101.LAB
XBRL Taxonomy Extension Label Linkbase Document.
X
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101.PRE
XBRL Taxonomy Extension Presentation Linkbase Document.
X
104
Cover Page Interactive Data File (formatted as Inline XBRL).
X
+
Indicates management contract or compensatory plan, contract or agreement.
†
Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulations S-K.
˄
Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of the omitted schedules and exhibits to the SEC upon request.
*
This certification is deemed not filed for purposes of section 18 of the Exchange Act or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
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Item 16. Form 10-K Summary.
Registrants may voluntarily include a summary of information required by Form 10-K under Item 16. We have elected not to include such summary.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) the Securities Exchange Act of 1934, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized.
PASSAGE BIO, INC.
Date: March 6, 2023
By:
/s/ William Chou, M.D.
Name:
William Chou, M.D.
Title:
Chief Executive Officer and Director
Date: March 6, 2023
By:
/s/ Simona King
Name:
Simona King
Title:
Chief Financial Officer
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POWER OF ATTORNEY
Each person whose individual signature appears below hereby authorizes and appoints William Chou, M.D., Simona King and Edgar B. Cale, and each of them, with full power of substitution and resubstitution, 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 attorney-in-fact and agents full power and authority to do and perform each and every act and thing, ratifying and confirming all that said attorney-in-fact and agents 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, 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/ William Chou, M.D.
President, Chief Executive Officer and Director
March 6, 2023
William Chou, M.D.
(Principal Executive Officer)
/s/ Simona King
Chief Financial Officer and Corporate Secretary
March 6, 2023
Simona King
(Principal Financial and Accounting Officer)
/s/ Maxine Gowen, Ph.D.
Director
March 6, 2023
Maxine Gowen, Ph.D.
/s/ Athena Countouriotis, M.D.
Director
March 6, 2023
Athena Countouriotis, M.D.
/s/ Saqib Islam
Director
March 6, 2023
Saqib Islam
/s/ Sandip Kapadia
Director
March 6, 2023
Sandip Kapadia
/s/ Michael Kamarck, Ph.D.
Director
March 6, 2023
Michael Kamarck, Ph.D.
/s/ Derrell Porter, M.D.
Director
March 6, 2023
Derrell Porter, M.D.
/s/ Tom Woiwode, Ph.D.
Director
March 6, 2023
Tom Woiwode, Ph.D.
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