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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 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.
+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 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, 2024, 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.
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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, 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.
+Added: Based on the evaluation of our disclosure controls and procedures as of December 31, 2024, 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.
−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 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.
+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 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:
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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.
−Removed: 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.
+Added: 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, 2024.
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) .
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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.
−Removed: 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.
+Added: 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, or a non-accelerated filer as defined in the Exchange Act, 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
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Other Information
+Added: During the three months ended December 31, 2024, none of our directors or officers, as defined in Rule 16a-1(f), informed us of the adoption, modification or termination of a “ Rule 10b5-1 trading agreement” or “ non-Rule 10b-51 trading agreement,” as those terms are defined in Regulations S-K, Item 408.
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
22 unchanged sentences
March 3, 2021
−Removed: Development Services and Clinical Supply Agreement, dated April 13, 2020, by and between the Registrant and Catalent Maryland, Inc.
Lease, dated April 10, 2020, by and between the Registrant and Commerce Square Partners - Philadelphia Plaza, L.P.
8 unchanged sentences
February 18, 2020
−Removed: 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 .
−Removed: August 13, 2020
−Removed: Amendment No.
−Removed: 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
−Removed: November 10, 2020
−Removed: Amendment No.
−Removed: 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
−Removed: January 19, 2021
−Removed: Amendment No.
−Removed: 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
−Removed: January 19, 2021
Lease, dated December 15, 2020 by and between the Registrant and Hopewell Campus Owner, LLC
2 unchanged sentences
July 19, 2021
−Removed: Amendment No.
−Removed: 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
−Removed: March 3, 2022
−Removed: Amendment No.
−Removed: 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
+Added: Employment Agreement, dated October 10, 2022 by and between the Registrant and William Chou.
November 10, 2022
−Removed: Amendment No.
−Removed: 6, dated November 12, 2021, to the Amended and Restated Sponsored Research, Collaboration and
+Added: Employment Agreement dated September 10, 2019, as amended on February 26, 2020, by and between the Registrant and Edgar B.
March 6, 2023
−Removed: License Agreement by and between the Registrant and the Trustees of the University of Pennsylvania
−Removed: Amendment No.
−Removed: 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
+Added: Amended and Restated Development Services and Clinical Supply Agreement, dated November 9, 2023, by and between the Registrant and Catalent Maryland, Inc.
March 4, 2024
−Removed: 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.
−Removed: August 4, 2022
−Removed: Employment Agreement, dated August 23, 2021 by and between the Registrant and Simona King.
−Removed: November 4, 2021
−Removed: Employment Agreement, dated October 10, 2022 by and between the Registrant and William Chou.
−Removed: November 10, 2022
−Removed: Employment Agreement dated September 10, 2019, as amended on February 26 th , 2020, by and between the Registrant and Edgar B.
+Added: Employment Agreement, dated March 30, 2022, by and between the Registrant and Mark Forman.
March 4, 2024
−Removed: Employment Agreement, dated July 22, 2019, as amended on February 14, 2020, by and between the Registrant and Alexandros Fotopoulos.
−Removed: February 18, 2020
−Removed: Transition and Separation Agreement, dated November 17, 2022, by and between the Registrant and Monika Toernsen.
+Added: Employment Agreement, dated March 1, 2024, by and between the Registrant and Kathleen Borthwick.
March 4, 2024
−Removed: Transition and Separation Agreement, dated July 19, 2023, by and between the Registrant and Simona King.
+Added: Non-Employee Director Compensation Policy effective as of April 4, 2024
+Added: Exclusive License Agreement (PBGM01), dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc.
November 13, 2024
−Removed: Transition and Separation Agreement, dated July 19, 2023, by and between the Registrant and Alexandros Fotopoulos.
+Added: Exclusive License Agreement (PBKR03), dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc.
November 13, 2024
−Removed: Amended and Restated Development Services and Clinical Supply Agreement, dated November 9, 2023, by and between the Registrant and Catalent Maryland, Inc.
−Removed: Employment Agreement, dated March 30, 2022, by and between the Registrant and Mark Forman.
−Removed: Employment Agreement, dated March 1, 2024, by and between the Registrant and Kathleen Borthwick.
+Added: Exclusive License Agreement (PBML04), dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc.
+Added: November 13, 2024
+Added: Transition Services Agreement, dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc.
+Added: November 13, 2024
+Added: Research, Collaboration & License Agreement, dated July 31, 2024, by and between the Registrant and Gemma Biotherapeutics, Inc.
+Added: November 13, 2024
+Added: Second Amended and Restated Research, Collaboration & License Agreement, dated July 31, 2024, by and between the Registrant and the Trustees of the University of Pennsylvania
+Added: November 13, 2024
+Added: Insider Trading Policy
Consent of KPMG LLP, an independent registered public accounting firm.
8 unchanged sentences
Policy Relating to Recovery of Erroneously Awarded Compensation
+Added: March 4, 2024
Inline XBRL Instance Document
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Sandip Kapadia
+Added: /s/ Thomas Kassberg
+Added: March 4, 2025
+Added: Thomas Kassberg
/s/ Derrell Porter, M.D.
5 unchanged sentences
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.