(a) The following documents are filed as a part of this annual report:
Information in response to this Item is included in Part II, Item 8 of this annual report.
| (2) | Financial Statement Schedule. |
All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto.
The following is a list of exhibits filed or furnished as part of this annual report:
| Exhibit number | Description |
| 3.1 | Third Amended and Restated Certificate of Incorporation of OS Therapies Incorporated.(1) |
| 3.2 | Certificate of Amendment to the Third Amended and Restated Certificate of Incorporation of OS Therapies Incorporated.(2) |
| 3.3 | Amended and Restated Bylaws of OS Therapies Incorporated.(1) |
| 3.4 | Certificate of Designation of Rights, Preferences and Limitations of Series A Senior Convertible Preferred Stock of OS Therapies Incorporated.(6) |
| 4.1 | Specimen Common Stock Certificate.(1) |
| 4.2 | Form of Representative’s Warrant.(3) |
| 4.3 | Form of Placement Agent Warrant (Group B Convertible Notes placement).(1) |
| 4.4 | Form of Placement Agent Warrant (Group C Convertible Notes placement).(1) |
| 4.5 | Form of Placement Agent Warrant (Group D Convertible Notes placement).(1) |
| 4.6 | Form of Common Stock Purchase Warrant.(6) |
| 4.7 | Form of Agent Warrant.(6) |
| 4.8 | Form of Warrant.(8) |
| 4.9* | Description of Registered Securities. |
| 10.1† | Form of Group A Convertible Note.(1) |
| 10.2†+ | Form of Group B Convertible Note.(1) |
| 10.3†+ | Form of Group C Convertible Note.(1) |
| 10.4†+ | Form of Groups D, E and F Convertible Note.(1) |
| 10.5+¥ | Amended and Restated Development, License and Supply Agreement, dated as of November 13, 2020, by and between OS Therapies Incorporated and Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.).(1) |
| 10.5.1 | First Amendment to Amended and Restated Development, License and Supply Agreement, dated as of April 23, 2021, between OS Therapies Incorporated and Advaxis, Inc. (now Ayala Pharmaceuticals, Inc.).(1) |
| 10.6+ | License Agreement, dated as of August 19, 2020, by and between OS Therapies Incorporated and BlinkBio, Inc.(1) |
| 10.7# | Employment Agreement, dated as of February 21, 2023, between OS Therapies Incorporated and Paul A. Romness, MPH.(1) |
| 10.8# | Employment Letter, dated June 23, 2020, between OS Therapies Incorporated and Robert G. Petit, Ph.D.(1) |
| 10.9# | Form of Indemnification Agreement between OS Therapies Incorporated and each of its directors.(1) |
| 10.10# | OS Therapies Incorporated 2023 Incentive Compensation Plan.(1) |
| 10.10.1# | Form of First Amendment to the OS Therapies Incorporated 2023 Incentive Compensation Plan.(1) |
| 10.11# | Employment Letter, dated January 1, 2023, between OS Therapies Incorporated and Christopher P. Acevedo.(1) |
| 10.12 | Equity Purchase Agreement between the registrant and Square Gate Capital Master Fund, LCC – Series 3, dated as of October 31, 2024.(4) |
| 10.13 | Registration Rights Agreement between the registrant and Square Gate Capital Master Fund, LCC – Series 3, dated as of October 31, 2024 (incorporated herein by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on November 1, 2024).(4) |
| 10.14+ | Securities Purchase Agreement, dated December 24, 2024, by and among OS Therapies Incorporated and the purchasers party thereto.(6) |
| 10.15 | Form of Registration Rights Agreement by and among OS Therapies Incorporated and the purchasers party thereto.(6) |
| 10.16 | Form of Voting Agreement by and among OS Therapies Incorporated, the stockholders party thereto and the purchasers party thereto.(6) |
| 10.17 | Letter Agreement, dated December 27, 2024, by and between OS Therapies Incorporated and Brookline Capital Markets, a division of Arcadia Securities, LLC.(6) |
| 10.18 | Amendment No. 1 to Securities Purchase Agreement and Amendment to Registration Rights Agreement.(7) |
| 10.19+ | Asset Purchase Agreement, dated as of January 28, 2025, between OS Therapies Incorporated and Ayala Pharmaceuticals, Inc.(8) |
| 10.20 | Form of Registration Rights Agreement between OS Therapies Incorporated and Ayala Pharmaceuticals, Inc.(8) |
| 23.1* | Consent of MaloneBailey, LLP, independent registered public accounting firm. |
| 31.1* | Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2* | Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1** | Certification of Principal Executive Officer Pursuant to 18 U.S.C. § 1350 As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 32.2** | Certification of Principal Financial Officer Pursuant to 18 U.S.C. § 1350 As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 97.1* | OS Therapies Incorporated Clawback Policy. |
| 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). |
| 101.SCH | Inline XBRL Taxonomy Extension Schema Document. |
| 101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document. |
| 101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document. |
| 101.LAB | Inline XBRL Taxonomy Extension Label Linkbase Document. |
| 101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document. |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
| (1) | Incorporated herein by reference to the Registrant’s Registration Statement on Form S-1 filed May 30, 2024 (File No. 333-279839). |
| (2) | Incorporated herein by reference to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 filed June 7, 2024 (File No. 333-279839). |
| (3) | Incorporated herein by reference to Amendment No. 2 to the Registrant’s Registration Statement on Form S-1 filed June 13, 2024 (File No. 333-279839). |
| (4) | Incorporated by reference to Exhibit 3.3 of the Registrant’s Registration Statement on Form S-1 filed May 30, 2024 (File No. 333-279839). |
| (5) | Incorporated herein by reference to the Registrant’s Current Report on Form 8-K filed on November 1, 2024. |
| (6) | Incorporated herein by reference to the Registrant’s Current Report on Form 8-K filed on December 30, 2024. |
| (7) | Incorporated herein by reference to the Registrant’s Current Report on Form 8-K filed on January 14, 2025. |
| (8) | Incorporated herein by reference to the Registrant’s Current Report on Form 8-K filed on January 29, 2025. |
| † | Pursuant to Instruction 2 to Item 601 of Regulation S-K, the convertible notes are identical for all noteholders in the particular group except for face or principal amount, issuance date and the name of the payee. |
| + | Pursuant to Item 601(a)(5) of Regulation S-K, certain schedules and exhibits have been omitted. The registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon its request. |
| ¥ | Pursuant to Item 601(b)(10)(iv) of Regulation S-K, certain portions of this exhibit have been redacted. Redacted information is indicated by [***]. |
| # | Indicates a management contract or any compensatory plan, contract or arrangement. |
| (b) | The exhibits required by Item 601 of Regulation S-K are filed herewith or incorporated herein by reference. Please see the Index to Exhibits to this annual report, which is incorporated into this Item 15(b) by reference. |
| (c) | All schedules are omitted because they are not applicable or the required information is shown in the financial statements or notes thereto. |