The following documents are included on pages set forth in Part II, Item 8 of this Annual Report on Form 10-K and are filed as part of this Annual Report on Form 10-K.
Index to Consolidated Financial Statements
| Report of Independent Registered Public Accounting Firm (PCAOB ID 42) | F-2 |
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| Consolidated Balance Sheets | F-3 |
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| Consolidated Statements of Operations and Comprehensive Loss | F-4 |
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| Consolidated Statements of Stockholders’ Equity | F-5 |
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| Consolidated Statements of Cash Flows | F-6 |
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| Notes to Consolidated Financial Statements | F-7 |
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| (2) | Financial Statement Schedules |
All financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the financial statements or the notes thereto.
The following is a list of exhibits filed as part of this Annual Report on Form 10-K.
EXHIBIT INDEX
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| · · · · Incorporated by Reference · · |
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| ExhibitNumber · Description of Exhibit · Form · File No. · Exhibit Number · Filing Date |
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| 3.1 | | Restated Certificate of Incorporation of the Registrant | | 8-K | | 001-40925 | | 3.1 | | October 26, 2021 |
| 3.2 | | Second Amended and Restated Bylaws of the Registrant | | 8-K | | 001-40925 | | 3.1 | | April 3, 2023 |
| 4.1 | | Specimen Stock Certificate evidencing the shares of common stock | | S-1 | | 333-259973 | | 4.1 | | October 1, 2021 |
| 4.2 | | Form of Prefunded Warrant | | 8-K | | 001-40925 | | 4.1 | | March 28, 2024 |
| 4.3 | | Description of the Registrant’s securities registered pursuant to Section 12 of the Securities and Exchange Act of 1934, as amended | | 10-K | | 001-40925 | | 4.3 | | March 1, 2022 |
| 10.1 | | 2020 Stock Incentive Plan, as amended | | S-1 | | 333-259973 | | 10.2 | | October 1, 2021 |
| 10.2 | | Form of Stock Option Agreement under 2020 Stock Incentive Plan | | S-1 | | 333-259973 | | 10.3 | | October 1, 2021 |
| 10.3 | | Form of Restricted Stock Agreement under 2020 Stock Incentive Plan | | S-1 | | 333-259973 | | 10.4 | | October 1, 2021 |
| 10.4 | | 2021 Stock Incentive Plan | | S-1 | | 333-259973 | | 10.5 | | October 18, 2021 |
| 10.5 | | Form of Stock Option Agreement under the 2021 Stock Incentive Plan | | S-1 | | 333-259973 | | 10.6 | | October 18, 2021 |
| 10.6 | | Form of Non-Employee Director Stock Option Agreement under the 2021 Stock Incentive Plan | | S-1 | | 333-259973 | | 10.7 | | October 18, 2021 |
| 10.7 | | Form of Restricted Unit Agreement under the 2021 Stock Incentive Plan | | 8-K | | 001-40925 | | 10.1 | | January 3, 2024 |
| 10.8 | | 2021 Employee Stock Purchase Plan | | S-1 | | 333-259973 | | 10.8 | | October 18, 2021 |
| 10.9 | | 2022 Inducement Stock Incentive Plan | | 10-K | | 001-40925 | | 10.8 | | March 2, 2023 |
| 10.10 | | Form of Stock Option Agreement under the 2022 Inducement Stock Incentive Plan | | 10-K | | 001-40925 | | 10.9 | | March 2, 2023 |
| 10.11 | | Form of Restricted Stock Unit Agreement under the 2022 Inducement Stock Incentive Plan | | 10-K | | 001-40925 | | 10.10 | | March 2, 2023 |
| 10.12 | | Sales Agreement, dated September 9, 2022, by and between the Registrant and Cowen and Company, LLC | | S-3 | | 333-268264 | | 1.2 | | November 9, 2022 |
| 10.13# | | Employment Agreement, dated September 30, 2021, by and between the Registrant and René Russo | | S-1 | | 333-259973 | | 10.15 | | October 1, 2021 |
| 10.14# | | Amended and Restated Employment Agreement, dated June 15, 2022, by and between the Registrant and Martin Huber, M.D. | | 8-K | | 001-40925 | | 10.1 | | June 16, 2022 |
| 10.15# | | Consulting Agreement, dated September 8, 2023, by and between the Registrant and Martin Huber, M.D. | | 10-Q | | 001-40925 | | 10.3 | | November 9, 2023 |
| 10.16# | | Second Amended and Restated Employment Agreement, dated August 3, 2023, by and between the Registrant and Christopher Frankenfield | | 8-K | | 001-40925 | | 10.1 | | August 3, 2023 |
| 10.17# | | Employment Agreement, dated September 5, 2023, by and between the Registrant and Kevin Brennan | | 8-K | | 001-40925 | | 10.1 | | September 5, 2023 |
| 10.18# | | Employment Agreement, dated September 5, 2023, by and between the Registrant and Katarina Luptakova, M.D. | | | | | | | | * |
| 10.19 | | Form of Indemnification Agreement between the Registrant and each of its Executive Officers and Directors | | S-1 | | 333-259973 | | 10.20 | | October 1, 2021 |
| 10.20 | | Amended and Restated Non-Employee Director Compensation Policy | | 10-Q | | 001-40925 | | 10.1 | | August 14, 2023 |
| 10.21† | | Cross-License Agreement, dated as of December 16, 2020, by and between the Registrant and AskGene Pharma, Inc. | | S-1 | | 333-259973 | | 10.11 | | October 1, 2021 |
| 10.22† | | Amended and Restated Exclusive License Agreement, dated as of August 16, 2016, by and between the Registrant and City of Hope | | S-1 | | 333-259973 | | 10.12 | | October 1, 2021 |
| 10.23† | | License Agreement, dated as of September 26, 2016, as amended, by and between the Registrant and WuXi Biologics (Hong Kong) Limited | | S-1 | | 333-259973 | | 10.13 | | October 1, 2021 |
| 10.24 | | Lease, dated as of August 26, 2019, by and between the Registrant and PPF OFF 828-830 Winter Street, LLC | | S-1 | | 333-259973 | | 10.14 | | October 1, 2021 |
| 10.25 | | Securities Purchase Agreement, dated March 28, 2024, among the Registrant and the persons party thereto | | 8-K | | 001-40925 | | 10.1 | | March 28, 2024 |
| 10.26 | | Registration Rights Agreement, dated March 28, 2024, among the Registrant and the persons party thereto | | 8-K | | 001-40925 | | 10.2 | | March 28, 2024 |
| 21.1 | | Subsidiaries of the Registrant | | | | | | | | * |
| 23.1 | | Consent of Ernst & Young LLP, independent registered public accounting firm | | | | | | | | * |
| 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 | | | | | | | | * |
| 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 | | | | | | | | * |
| 32.1+ | | Certification of Principal Executive Officer and Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | | | | | | | | * |
| 97# | | Executive Compensation Clawback Policy | | | | | | | | * |
| 101.INS | | 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 | | | | | | | | * |
| 101.SCH | | Inline XBRL Taxonomy Extension Calculation Linkbase Document | | | | | | | | * |
| 101.CAL | | Inline XBRL Taxonomy Extension Definition Linkbase Document | | | | | | | | * |
| 101.DEF | | Inline XBRL Taxonomy Extension Label Linkbase Document | | | | | | | | * |
| 101.LAB | | Inline XBRL Taxonomy Extension Presentation Linkbase Document | | | | | | | | * |
| 104 | | Cover Page Interactive Data File (formatted as Inline XBRL with applicable taxonomy extension information contained in Exhibits 101) | | | | | | | | |
| # | Indicates management contract or compensatory plan or arrangement. |
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| † | Portions of this exhibit have been omitted pursuant to Item 601 of Regulation S-K promulgated under the Securities Act because the information is not material and is a type of information that the registrant treats as private or confidential. |
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| + | The certifications attached as Exhibit 32.1 are being furnished solely to accompany this Annual Report on Form 10-K and will not be deemed to be “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 to be incorporated by reference into any filing under the Securities Act or the Exchange Act, except to the extent that the Registrant specifically incorporates it by reference into such filing. |
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