1 unchanged sentence
Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures
−Removed: 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.
+Added: Under the supervision of and with the participation of our management, including our chief executive officer, who is our principal executive officer, and our interim 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, 2023, 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.
1 unchanged sentence
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.
−Removed: 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.
+Added: Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our chief executive officer and interim 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.
−Removed: 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.
+Added: 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 interim 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.
Our internal control over financial reporting includes those policies and procedures that:
7 unchanged sentences
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.
−Removed: The design of any disclosure controls and procedures also is based in part upon certain assumptions
−Removed: 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.
−Removed: 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.
+Added: The design of any disclosure controls and procedures also is based in part upon certain assumptions 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.
+Added: Our management, with the participation of our chief executive officer and interim chief financial officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2023.
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) .
3 unchanged sentences
Changes in Internal Control over Financial Reporting
−Removed: 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.
+Added: 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 three months ended December 31, 2023, that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
Other Information
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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.
−Removed: (3) Exhibits.
−Removed: Restated Certificate of Incorporation, dated March 3, 2020.
+Added: Restated Certificate of Incorporation, dated May 30, 2023.
+Added: August 7, 2023
Amended and Restated Bylaws, dated December 1, 2022.
2 unchanged sentences
February 18, 2020
−Removed: Amended and Restated Investors' Rights Agreement, dated August 21, 2019, by and among the Registrant and certain of its stockholders.
−Removed: February 3, 2020
Description of Registrant’s Securities
11 unchanged sentences
February 18, 2020
−Removed: Amended and Restated Employment Agreement dated February 14, 2020, by and between the Registrant and Bruce Goldsmith.
−Removed: February 18, 2020
−Removed: Consulting Agreement, dated January 8, 2019, as amended on January 31, 2020, by and between the Registrant and James Wilson, M.D., Ph.D.
−Removed: February 3, 2020
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 .
20 unchanged sentences
Amendment No.
−Removed: 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
+Added: 6, dated November 12, 2021, to the Amended and Restated Sponsored Research, Collaboration and
March 3, 2022
+Added: License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
Amendment No.
7 unchanged sentences
November 10, 2022
−Removed: Transition and Separation Agreement, dated May 27, 2022 by and between the Registrant and Bruce Goldsmith.
−Removed: August 4, 2022
Employment Agreement dated September 10, 2019, as amended on February 26 th , 2020, by and between the Registrant and Edgar B.
+Added: March 6, 2023
Employment Agreement, dated July 22, 2019, as amended on February 14, 2020, by and between the Registrant and Alexandros Fotopoulos.
1 unchanged sentence
Transition and Separation Agreement, dated November 17, 2022, by and between the Registrant and Monika Toernsen.
+Added: March 6, 2023
+Added: Transition and Separation Agreement, dated July 19, 2023, by and between the Registrant and Simona King.
+Added: November 13, 2023
+Added: Transition and Separation Agreement, dated July 19, 2023, by and between the Registrant and Alexandros Fotopoulos.
+Added: November 13, 2023
+Added: Amended and Restated Development Services and Clinical Supply Agreement, dated November 9, 2023, by and between the Registrant and Catalent Maryland, Inc.
+Added: Employment Agreement, dated March 30, 2022, by and between the Registrant and Mark Forman.
+Added: Employment Agreement, dated March 1, 2024, by and between the Registrant and Kathleen Borthwick.
Consent of KPMG LLP, an independent registered public accounting firm.
7 unchanged sentences
Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
+Added: Policy Relating to Recovery of Erroneously Awarded Compensation
Inline XBRL Instance Document
6 unchanged sentences
Indicates management contract or compensatory plan, contract or agreement.
−Removed: Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulations S-K.
+Added: Registrant has omitted portions of the exhibit as permitted under Item 601(b)(10) of Regulation S-K.
Registrant has omitted schedules and exhibits pursuant to Item 601(a)(5) of Regulation S-K.
11 unchanged sentences
March 4, 2024
−Removed: /s/ Simona King
+Added: /s/ Kathleen Borthwick
+Added: Kathleen Borthwick
Chief Financial Officer
POWER OF ATTORNEY
−Removed: Each person whose individual signature appears below hereby authorizes and appoints William Chou, M.D., Simona King and Edgar B.
+Added: Each person whose individual signature appears below hereby authorizes and appoints William Chou, M.D., Kathleen Borthwick 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.
5 unchanged sentences
(Principal Executive Officer)
−Removed: /s/ Simona King
−Removed: Chief Financial Officer and Corporate Secretary
+Added: /s/ Kathleen Borthwick
+Added: Chief Financial Officer
March 4, 2024
+Added: Kathleen Borthwick
(Principal Financial and Accounting Officer)
10 unchanged sentences
Sandip Kapadia
−Removed: /s/ Michael Kamarck, Ph.D.
−Removed: March 6, 2023
−Removed: Michael Kamarck, Ph.D.
/s/ Derrell Porter, M.D.
1 unchanged sentence
Derrell Porter, M.D.
−Removed: /s/ Tom Woiwode, Ph.D.
+Added: /s/ Dolan Sondhi, Ph.D.
March 4, 2024
−Removed: Tom Woiwode, Ph.D.
+Added: Dolan Sondhi, Ph.D.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.