ELUTIA INC. 10-K

Item 9A. Controls and Procedures. Limitations on Effectiveness of Controls and Procedures In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs. Evaluation of Disclosure Controls and Procedures The Company’s management has evaluated, with the participation of our principal executive officer and our principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Annual Report. Based on this evaluation, management concluded that the Company’s disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2024. Management’s Annual Report on Internal Control Over Financial Reporting O ur management, with the participation of our principal executive officer and our principal financial officer, is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our management conducted an assessment of the effectiveness of our internal control over financial reporting based on the criteria set forth in “Internal Control–Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this assessment, management concluded that, as of December 31, 2024, our internal control over financial reporting was effective. Attestation Report of the Registered Public Accounting Firm Our independent registered accounting firm will not be required to opine on the effectiveness of our internal control over financial reporting pursuant to Section 404 of Sarbanes-Oxley Act of 2002 until we are no longer an “emerging growth company” as defined in the JOBS Act. Changes in Internal Control over Financial Reporting There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months and year ended December 31, 2024 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. ​ Item 9B. Other Information. During the three months ended December 31, 2024, none of our directors or officers (as defined in Rule 16a-1 under the Exchange Act) adopted or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any "non-Rule 10b5-1 trading arrangement" (as defined in Item 408 of Regulation S-K). ​ Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections ​ Not applicable. 95 ​ Table of Contents ​ PART III Item 10. Directors, Executive Officers and Corporate Governance. The information required by this Item 10 is incorporated herein by reference to the information that will be contained in our proxy statement related to our annual meeting of stockholders to be held in 2025 (the “2025 Annual Meeting of Stockholders”), which we intend to file with the SEC within 120 days of the year ended December 31, 2024. A copy of our Insider Trading Compliance Policy is filed as Exhibit 19 to this Annual Report on Form 10-K. ​ ​ Item 11. Executive Compensation. The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2024. ​ Item 12. Security Ownership of Certain Beneficial Owners and Management Related Stockholder Matters. Equity Compensation Plan Information The following table provides information on our equity compensation plans as of December 31, 2024. ​ ​ ​ ​ ​ ​ ​ ​ ​ Number of ​ ​ Number of securities ​ ​ Securities to be ​ ​ ​ ​ remaining available for ​ ​ Issued Upon ​ ​ ​ ​ future issuance under ​ ​ Exercise of ​ Weighted Average ​ equity compensation ​ ​ Outstanding ​ Exercise Price of ​ plans (excluding ​ ​ Options, Warrants ​ Outstanding Options, ​ securities reflected in ​ ​ and Rights ​ Warrants and Rights ​ column (a)) Plan Category ​ (a) ​ (b) ​ (c) Equity Compensation Plans Approved by Stockholders ​ ​ 2015 Plan (1) 33,836 ​ $ 5.94 (4) — 2020 Plan (2) 4,604,278 ​ $ 5.22 (4) 396,561 ESPP (3) — ​ — ​ 471,126 Equity Compensation Plans Not Approved by Stockholders — ​ — ​ — Total 4,638,114 ​ $ — ​ 867,687 (1) In connection with our IPO, we adopted the Elutia Inc. 2020 Incentive Award Plan (the “2020 Plan”) and, as of the consummation of our IPO, ceased making grants or awards under the Elutia Inc. 2015 Stock Option/Stock Issuance Plan (the “2015 Plan”). To the extent stock options outstanding under the 2015 Plan are forfeited, lapse unexercised or are settled in cash, the shares of Class A common stock subject to the stock options will be available for future issuance under the 2020 Plan. (2) 1,685,962 shares of Class A common stock were initially available for issuance under the 2020 Plan. The number of shares of Class A common stock available for issuance under the 2020 Plan automatically increases on each January 1, until and including January 1, 2030, by an amount equal to the lesser of (A) 4% of the shares of Class A common stock outstanding (on an as-converted basis) on the last day of the immediately preceding fiscal year and (B) such smaller number of shares of Class A common stock as determined by our board of directors (but no more than 1,636,000 shares of Class A common stock may be issued upon the exercise of incentive stock options). In addition, the shares reserved for issuance under the 2020 Plan will also include shares reserved but not issued under the 2015 Plan. In June 2023, the stockholders of the Company approved the amendment and restatement of the 2020 Plan which, among other things, increased the number of shares of Class A common stock reserved for issuance under the 2020 Plan by 2,000,000 shares. 96 ​ Table of Contents (3) The number of shares of Class A common stock available for issuance under the ESPP automatically increases on each January 1, until and including January 1, 2030, by an amount equal to the lesser of (A) 1% of the shares of Class A and Class B common stock outstanding on the last day of the immediately preceding fiscal year and (B) such smaller number of shares of Class A common stock as determined by our board of directors. (4) The calculation of the weighted average exercise price does not include outstanding equity awards that are received or exercised for no consideration. The other information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2024. ​ Item 13. Certain Relationships and Related Transactions, and Director Independence. The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2024. ​ Item 14. Principal Accountant Fees and Services. The information required by this Item is incorporated herein by reference to the information that will be contained in our proxy statement related to the 2025 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2024. ​ PART IV Item 15. Exhibits and Financial Statement Schedules. (a)(1) Financial Statements The Consolidated Financial Statements are included on pages F-2 through F-31 attached hereto and are filed as part of this Annual Report. See Index to Consolidated Financial Statements on page F-1. (a)(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. (a)(3) Exhibits The following is a list of exhibits filed as part of this Annual Report. Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 2.1 ​ Asset Purchase Agreement, dated September 17, 2023, by and among Elutia Inc., Berkeley Biologics, LLC, and GNI Group, Ltd. (solely with respect to Section 11.18) ​ 8-K ​ 001-39577 ​ 10.1 ​ 9/19/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 97 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 3.1a ​ Restated Certificate of Incorporation of Elutia Inc. ​ 8-K ​ 001-39577 ​ 3.1 ​ 10/13/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 3.1b ​ Certificate of Amendment to the Restated Certificate of Incorporation of Elutia Inc. ​ 8-K ​ 001-39577 ​ 3.1 ​ 09/07/2023 ​ ​ ​ ​ ​ ​ 3.2 ​ Amended and Restated Bylaws of Elutia Inc. ​ 8-K ​ 001-39577 ​ 3.2 ​ 10/13/2020 ​ ​ ​ ​ ​ 4.1 ​ Second Amended and Restated Investor Rights Agreement, dated as of September 14, 2020, among the Registrant and the investors named therein ​ S-1 ​ 333-248788 ​ 4.1 ​ 09/14/2020 ​ ​ ​ ​ ​ 4.2 ​ Specimen stock certificate evidencing the shares of Class A common stock ​ S-1 ​ 333-248788 ​ 4.2 ​ 09/14/2020 ​ ​ ​ ​ ​ 4.3 ​ Specimen stock certificate evidencing the shares of Class B common stock ​ S-1/A ​ 333-248788 ​ 4.3 ​ 09/30/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.4 ​ Warrant to Purchase Stock, issued on August 10, 2022, by Elutia Inc.to SWK Funding LLC. ​ ​ 8-K ​ 001-39577 ​ 4.1 ​ 8/15/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.5 ​ Form of Common Warrant ​ 8-K ​ 001-39577 ​ 4.1 ​ 9/21/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.6 ​ 2023 Form of Prefunded Warrant ​ 8-K ​ 001-39577 ​ 4.2 ​ 9/21/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.7 ​ Registration Rights Agreement, dated September 21, 2023, by and among Elutia Inc. and the Investors named therein ​ 8-K ​ 001-39577 ​ 10.2 ​ 9/21/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.8 ​ 2024 Form of Prefunded Warrant ​ 8-K ​ 001-39577 ​ 4.1 ​ 6/18/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 98 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 4.9 ​ Description of Securities ​ 10-K ​ 001-39577 ​ 4.4 ​ 03/15/2021 ​ ​ ​ ​ ​ 10.1 ​ Registration Rights Agreement, dated December 5, 2021, by and among Elutia Inc. and the Investors named therein. ​ 8-K ​ 001-39577 ​ 10.2 ​ 12/08/2021 ​ ​ ​ ​ ​ ​ 10.2 ​ Royalty Agreement, dated as of May 31, 2017, by and between Elutia Med, LLC and Ligand Pharmaceuticals Incorporated ​ S-1 ​ 333-248788 ​ 10.15 ​ 09/14/2020 ​ ​ ​ ​ ​ 10.3 ​ License Agreement, dated as of May 31, 2017, by and between Cook Biotech Incorporated and Elutia Med, LLC ​ S-1 ​ 333-248788 ​ 10.16 ​ 09/14/2020 ​ ​ ​ ​ ​ 10.4 ​ December 2017 Amendment to License Agreement, dated as of December 21, 2017, by and between Cook Biotech Incorporated and Elutia Med, LLC ​ S-1 ​ 333-248788 ​ 10.17 ​ 09/14/2020 ​ ​ ​ ​ ​ 10.5† ​ Elutia Inc. 2015 Stock Option/Stock Issuance Plan (as amended) ​ S-1 ​ 333-248788 ​ 10.1 ​ 09/14/2020 ​ ​ ​ ​ ​ 10.6† ​ Elutia Inc. 2020 Incentive Award Plan and form of stock option agreements thereunder ​ 10-K ​ 001-39577 ​ 10.6 ​ 3/23/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.7† ​ Form of Restricted Stock Unit Award Agreement (approved August 2022) ​ 10-Q ​ 001-39577 ​ 10.4 ​ 11/14/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.8† ​ Form of Restricted Stock Unit Award Agreement (approved October 2020) ​ 10-K ​ 001-39577 ​ 10.8 ​ 3/23/2023 ​ ​ ​ ​ ​ 10.9† ​ Elutia Inc. Non-Employee Director Compensation Program ​ S-1/A ​ 333-248788 ​ 10.3 ​ 09/30/2020 99 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.10† ​ Elutia Inc. 2020 Employee Stock Purchase Plan ​ S-1/A ​ 333-248788 ​ 10.4 ​ 09/30/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.11† ​ Amended and Restated Employment Agreement, by and between the Registrant and Ronald Lloyd, dated as of September 30, 2021 ​ S-1/A ​ 333-248788 ​ 10.6 ​ 09/30/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.12† ​ Separation and Release of Claims Agreement, dated June 21, 2022, by and between Ronald Lloyd and Elutia Inc. ​ ​ 8-K ​ 001-39577 ​ 10.1 ​ 6/21/2022 ​ 10.13† ​ Employment Agreement, dated June 21, 2022, by and between C. Randal Mills, Ph.D. and Elutia Inc. ​ 8-K ​ 001-39577 ​ 10.2 ​ 6/21/2022 ​ ​ ​ ​ ​ ​ 10.14† ​ Amended and Restated Employment Agreement, dated December 23, 2022, by and between Elutia Inc. and Thomas Englese ​ 8-K ​ 001-39577 ​ 10.2 ​ 12/30/2022 ​ ​ ​ ​ ​ 10.15† ​ Letter Agreement, dated as of March 22, 2023, by and between Elutia Inc. and Thomas Englese ​ 10-K ​ 001-39577 ​ 10.15 ​ 3/23/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.16† ​ Amended and Restated Employment Agreement, dated December 23, 2022, by and between Elutia Inc. and Matthew Ferguson ​ 8-K ​ 001-39577 ​ 10.1 ​ 12/30/2022 ​ ​ ​ ​ ​ 10.17† ​ Form of Indemnification Agreement for Directors and Officers ​ S-1/A ​ 333-248788 ​ 10.12 ​ 09/30/2020 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.18# ​ Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as ​ 8-K ​ 001-39577 ​ 10.1 ​ 8/15/2022 ​ 100 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Agent and the Lenders from time to time party thereto ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.19 ​ Amendment Letter, dated as of October 9, 2022 to Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as Agent and the Lenders from time to time party thereto ​ ​ 8-K ​ 001-39577 ​ 10.1 ​ 10/13/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.20 ​ Amendment Letter, dated as of November 10, 2022 to Credit Agreement, dated as of August 10, 2022, between Elutia Inc. and SWK Funding LLC, as Agent and the Lenders from time to time party thereto (as amended by the Amendment Letter dated as of October 9, 2022) ​ ​ 10-Q ​ 001-39577 ​ 10.3 ​ 11/14/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.21 ​ Amendment Letter, dated as of November 21, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended). ​ 8-K ​ 001-39577 ​ 10.1 ​ 11/28/2022 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.22 ​ Amendment Letter, dated as of November 30, 2022, to the Credit Agreement, dated as of August 10, 2022, among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto (as amended). ​ 8-K ​ 001-39577 ​ 10.1 ​ 12/5/2022 ​ 101 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.23 ​ First Amendment, dated as of May 12, 2023, to the Credit Agreement, dated August 10, 2022, by and among Aziyo Biologics, Inc., SWK Funding LLC, as Agent and the Lenders from time to time party thereto ​ 10-Q ​ 001-39577 ​ 10.4 ​ 5/12/2023 ​ ​ ​ ​ ​ ​ 10.24† ​ Aziyo Biologics, Inc. Amended and Restated 2020 Incentive Award Plan ​ Proxy Statement ​ 001-39577 ​ Annex A ​ 04/27/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.25 ​ Distribution Agreement by and between Aziyo Biologics, Inc. and LeMaitre Vascular, Inc. ​ 10-Q ​ 001-39577 ​ 10.2 ​ 8/14/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.26 ​ Securities Purchase Agreement, dated September 18, 2023, by and among Elutia Inc. and the Investors named therein. ​ 8-K ​ 001-39577 ​ 10.1 ​ 9/21/2023 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.27 ​ Amendment No. 1 to Royalty Agreement with Ligand Pharmaceuticals Incorporated ​ 8-K ​ 001-39577 ​ 10.1 ​ 1/12/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.28† ​ Form of Amendment to Stock Option Agreements, dated January 31, 2024, between the Company and C. Randal Mills, Ph.D. ​ 8-K ​ 001-39577 ​ 10.1 ​ 2/2/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.29† ​ Form of Amendment to Restricted Stock Unit Agreements, dated January 31, 2024, between the Company and C. Randal Mills, Ph.D. ​ 8-K ​ 001-39577 ​ 10.2 ​ 2/2/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 102 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.30† ​ Form of Stock Option Agreement under the Elutia Inc. Amended and Restated 2020 Incentive Award Plan. ​ 8-K ​ 001-39577 ​ 10.3 ​ 2/2/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.31† ​ ​ Form of Restricted Stock Unit Agreement under the Elutia Inc. Amended and Restated 2020 Incentive Award Plan. ​ 8-K ​ 001-39577 ​ 10.4 ​ 2/2/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.32 ​ Second Amendment to Credit Agreement, dated March 27, 2024, by and among Elutia Inc., SWK Funding LLC, as Agent, and the Lenders from time to time party thereto. ​ 8-K ​ 001-39577 ​ 10.1 ​ 4/1/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.33 ​ Placement Agency Agreement, dated June 16, 2024, by and between Elutia Inc. and Lake Street Capital Markets, LLC ​ 8-K ​ 001-39577 ​ 10.1 ​ 6/18/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 10.34 ​ Form of Securities Purchase Agreement ​ 8-K ​ 001-39577 ​ 10.2 ​ 6/18/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 19 ​ Insider Trading Compliance Policy ​ ​ ​ ​ ​ ​ ​ ​ * ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 21.1 ​ Subsidiaries of Elutia, Inc. ​ 10-K ​ 001-39577 ​ 21.1 ​ 03/8/2022 ​ ​ ​ ​ ​ 23.1 ​ Consent of PricewaterhouseCoopers LLP ​ ​ ​ ​ * ​ ​ ​ ​ ​ 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. ​ ​ ​ ​ * ​ ​ ​ ​ ​ 103 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 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 Pursuant to 18 U.S.C. Section 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. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. ​ ​ ​ ​ ** ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 97 ​ Elutia Inc. Excess Incentive-based Compensation Recoupment Policy ​ 10-K ​ 001-39577 ​ ​ 97 ​ 3/11/2024 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 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 ​ ​ ​ ​ * ​ ​ ​ ​ ​ 104 ​ Table of Contents Exhibit Number Description Form File No. Exhibit Filing Date Filed/Furnished Herewith ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 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) ​ ​ ​ ​ ​ ​ ​ ​ * * Filed herewith. ** Furnished herewith. † Denotes a management contract or compensation plan or arrangement. ​ # Annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5)(b)(2) of Regulation S-K. The Registrant hereby agrees to furnish supplementally a copy of any omitted annex, schedule or exhibit to the SEC upon request. ​ Item 16. Form 10-K Summary. None. ​ 105 ​ Table of Contents SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. Elutia Inc. Date: March 11, 2025 By: /s/ C. RANDAL MILLS, PH.D. C. Randal Mills, Ph.D. President and Chief Executive Officer (Principal Executive Officer) Date: March 11, 2025 /s/ MATTHEW FERGUSON Matthew Ferguson Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) ​ Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated. Name Title Date /s/C. Randal Mills, Ph.D. President, Chief Executive Officer and Director (principal executive officer) March 11, 2025 C. Randal Mills, Ph.D. /s/Matthew Ferguson Chief Financial Officer (principal financial officer and principal accounting officer) March 11, 2025 Matthew Ferguson /s/Kevin Rakin Chairperson of the Board of Directors March 11, 2025 Kevin Rakin /s/W. Matthew Zuga Director March 11, 2025 W. Matthew Zuga /s/Maybelle Jordan Director March 11, 2025 Maybelle Jordan /s/David Colpman Director March 11, 2025 David Colpman /s/Brigid A. Makes Director March 11, 2025 Brigid A. Makes ​ ​ ​ 106 ​ Table of Contents ELUTIA INC. INDEX TO FINANCIAL STATEMENTS Report of Independent Registered Public Accounting Firm (PCAOB ID: 238 ) F-2 ​ ​ Consolidated Balance Sheets F-3 ​ ​ Consolidated Statements of Operations F-4 ​ ​ Consolidated Statements of Changes in Stockholders’ Equity (Deficit) F-5 ​ ​ Consolidated Statements of Cash Flows F-6 ​ ​ Notes to Consolidated Financial Statements F-7 ​ ​ ​ ​ F-1 Table of Contents Report of Independent Registered Public Accounting Firm ​ To the Board of Directors and Stockholders of Elutia Inc. Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of Elutia Inc. and its subsidiaries (the “Company”) as of December 31, 2024 and 2023, and the related consolidated statements of operations, of changes in stockholders’ equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America. Substantial Doubt about the Company’s Ability to Continue as a Going Concern ​ The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has generated recurring losses from operations and is expected to incur cash outflows from operating activities that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Basis for Opinion These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion. Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion. ​ /s/ PricewaterhouseCoopers LLP Philadelphia, Pennsylvania March 11, 2025 We have served as the Company’s auditor since 2015. ​ F-2 Table of Contents ELUTIA INC. CONSOLIDATED BALANCE SHEETS (In Thousands, Except for Share and Per Share Data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ December 31, ​ 2024 2023 Assets ​ ​ ​ ​ ​ ​ Current assets: ​ ​ ​ ​ ​ ​ Cash and cash equivalents ​ $ 13,239 ​ $ 19,276 Accounts receivable, net ​ 2,276 ​ 3,263 Inventory ​ 3,911 ​ 3,853 Insurance receivables of litigation costs ​ ​ 4,760 ​ ​ 2,696 Prepaid expenses and other current assets ​ 1,986 ​ 2,165 Total current assets ​ 26,172 ​ 31,253 ​ ​ ​ ​ ​ ​ ​ Property and equipment, net ​ 773 ​ 172 Intangible assets, net ​ 8,273 ​ 11,671 Operating lease right-of-use assets and other ​ 909 ​ 332 Total assets ​ $ 36,127 ​ $ 43,428 ​ ​ ​ ​ ​ ​ ​ Liabilities and Stockholders’ Equity (Deficit) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Current liabilities: ​ ​ ​ ​ ​ ​ Accounts payable ​ $ 4,149 ​ $ 3,191 Accrued expenses ​ 7,104 ​ 9,485 Current portion of long-term debt ​ 1,250 ​ 3,321 Current portion of revenue interest obligation ​ 4,400 ​ 11,741 Contingent liability for legal proceedings ​ ​ 20,432 ​ ​ 15,024 Current operating lease liabilities ​ 460 ​ 275 Total current liabilities ​ 37,795 ​ 43,037 ​ ​ ​ ​ ​ ​ ​ Long-term debt ​ 22,603 ​ 20,356 Long-term revenue interest obligation ​ 5,490 ​ 5,360 Warrant liability ​ 16,076 ​ 12,760 Long-term operating lease liabilities ​ ​ 423 ​ ​ — Other long-term liabilities ​ — ​ 515 Total liabilities ​ 82,387 ​ 82,028 ​ ​ ​ ​ ​ ​ ​ Commitments and contingencies (Note 17) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Stockholders’ equity (deficit): ​ ​ ​ ​ ​ ​ Class A Common stock, $ 0.001 par value, 200,000,000 shares authorized as of December 31, 2024 and December 31, 2023, and 30,897,232 and 18,884,196 shares issued and outstanding, as of December 31, 2024 and December 31, 2023, respectively ​ ​ 31 ​ ​ 19 Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized, as of December 31, 2024 and December 31, 2023 and 4,313,406 issued and outstanding as of December 31, 2024 and December 31, 2023 ​ ​ 4 ​ ​ 4 Additional paid-in capital ​ 183,298 ​ 137,021 Accumulated deficit ​ ( 229,593 ) ​ ( 175,644 ) Total stockholders’ deficit ​ ( 46,260 ) ​ ( 38,600 ) Total liabilities and stockholders' deficit ​ $ 36,127 ​ $ 43,428 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ ​ F-3 Table of Contents ​ ELUTIA INC. CONSOLIDATED STATEMENTS OF OPERATIONS (In Thousands, Except Share and Per Share Data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 Net sales ​ $ 24,375 ​ $ 24,745 Cost of goods sold ​ 13,668 ​ 13,692 Gross profit ​ 10,707 ​ 11,053 Sales and marketing ​ 12,546 ​ 13,087 General and administrative ​ 18,659 ​ 14,104 Research and development ​ 3,785 ​ 4,399 Litigation costs, net ​ ​ 11,368 ​ ​ 9,989 Total operating expenses ​ ​ 46,358 ​ ​ 41,579 Loss from continuing operations ​ ( 35,651 ) ​ ( 30,526 ) Interest expense, net ​ 4,779 ​ 5,796 Loss on revaluation of warrant liability ​ ​ 14,878 ​ ​ 4,140 Other (income) expense, net ​ ( 1,186 ) ​ 759 Loss before provision for income taxes ​ ( 54,122 ) ​ ( 41,221 ) Income tax expense ​ 7 ​ 28 Net loss from continuing operations ​ ​ ( 54,129 ) ​ ​ ( 41,249 ) Income from discontinued operations ​ ​ 180 ​ ​ 3,593 Net loss ​ $ ( 53,949 ) ​ $ ( 37,656 ) Net loss per share from continuing operations attributable to common stockholders - basic and diluted ​ $ ( 1.86 ) ​ $ ( 2.27 ) Income per share from discontinued operations attributable to common stockholders - basic and diluted ​ $ 0.01 ​ $ 0.20 Net loss per share - basic and diluted ​ $ ( 1.86 ) ​ $ ( 2.07 ) ​ ​ ​ ​ ​ ​ ​ Weighted average common shares outstanding - basic and diluted ​ 29,071,113 ​ 18,160,822 ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-4 Table of Contents ELUTIA INC. CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT) (In Thousands, Except Share and Per Share Data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Class A ​ Class B ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Stock ​ Common Stock ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ Total ​ ​ Number of ​ ​ ​ ​ Number of ​ ​ ​ ​ Paid-in ​ Accumulated ​ Stockholders' ​ Shares Amount Shares Amount ​ Capital ​ Deficit Equity (Deficit) Balance, December 31, 2022 11,823,445 ​ $ 12 ​ 4,313,406 ​ $ 4 ​ $ 132,939 ​ $ ( 137,988 ) ​ $ ( 5,033 ) Issuance of common stock in connection with private placement, net of issuance costs of $ 0.4 million ​ 6,852,811 ​ ​ 7 ​ — ​ ​ — ​ ​ 1,458 ​ ​ — ​ ​ 1,465 Issuance of common stock under Employee Stock Purchase Plan ​ 104,905 ​ ​ — ​ — ​ ​ — ​ ​ 219 ​ ​ — ​ ​ 219 Vesting of restricted stock units, net of shares withheld and taxes paid ​ 103,035 ​ ​ — ​ — ​ ​ — ​ ​ ( 32 ) ​ ​ — ​ ​ ( 32 ) Stock-based compensation ​ — ​ ​ — ​ — ​ ​ — ​ ​ 2,437 ​ ​ — ​ ​ 2,437 Net loss ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ ( 37,656 ) ​ ​ ( 37,656 ) Balance, December 31, 2023 18,884,196 ​ $ 19 ​ 4,313,406 ​ $ 4 ​ $ 137,021 ​ $ ( 175,644 ) ​ $ ( 38,600 ) Issuance of common stock in connection with registered direct offering, net of issuance costs of $ 1.1 million 3,175,000 ​ ​ 3 ​ — ​ ​ — ​ ​ 9,669 ​ ​ — ​ 9,672 Exercise of stock options ​ 1,960 ​ ​ — ​ — ​ ​ — ​ ​ 7 ​ ​ — ​ ​ 7 Exercise of Common Warrants and Prefunded Warrants ​ 7,963,373 ​ ​ 8 ​ — ​ ​ — ​ ​ 29,744 ​ ​ — ​ ​ 29,752 Issuance of common stock under Employee Stock Purchase Plan ​ 96,658 ​ ​ — ​ — ​ ​ — ​ 155 ​ — ​ ​ 155 Vesting of restricted stock units, net of shares withheld and taxes paid ​ 776,045 ​ ​ 1 ​ — ​ ​ — ​ ​ ( 1,189 ) ​ ​ — ​ ​ ( 1,188 ) Stock-based compensation ​ — ​ ​ — ​ — ​ ​ — ​ ​ 7,891 ​ ​ — ​ ​ 7,891 Net loss ​ — ​ ​ — ​ — ​ ​ — ​ ​ — ​ ​ ( 53,949 ) ​ ​ ( 53,949 ) Balance, December 31, 2024 30,897,232 ​ $ 31 ​ 4,313,406 ​ $ 4 ​ $ 183,298 ​ $ ( 229,593 ) ​ $ ( 46,260 ) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-5 Table of Contents ELUTIA INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (In Thousands) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ ​ 2024 2023 Net loss ​ $ ( 53,949 ) $ ( 37,656 ) Adjustments to reconcile net loss to net cash used in operating activities: ​ Depreciation and amortization ​ 3,451 3,748 Gain on sale of Orthobiologics Business, excluding divestiture costs ​ ​ ( 180 ) ​ ​ ( 7,529 ) Loss on revaluation of warrant liability ​ 14,878 4,140 Gain on revaluation of revenue interest obligation ​ ( 1,443 ) — Amortization of deferred financing costs and debt discount ​ ​ 216 216 Interest expense recorded as additional revenue interest obligation and long-term debt ​ ​ 3,076 3,350 Stock-based compensation ​ ​ 7,891 2,437 Bad debt expense ​ ​ 460 ​ ​ 590 Losses associated with viable bone matrix recall and market withdrawal ​ ​ — ​ ​ 1,984 Changes in operating assets and liabilities, net: ​ ​ ​ ​ Accounts receivable ​ 527 802 Inventory ​ ( 58 ) ( 609 ) Insurance receivables of litigation costs ​ ​ ( 2,064 ) ​ ​ 11,118 Prepaid expenses and other ​ 743 167 Accounts payable and accrued expenses ​ ( 1,148 ) ( 2,113 ) Contingent liability for legal proceedings ​ ​ 5,408 ​ ​ ( 2,336 ) Other liabilities ​ ( 465 ) ( 70 ) Net cash used in operating activities ​ ( 22,657 ) ( 21,761 ) INVESTING ACTIVITIES: ​ ​ Proceeds from sale of Orthobiologics Business ​ ​ 180 ​ ​ 14,554 Expenditures for property, plant and equipment ​ ( 654 ) ( 346 ) Net cash (used in) provided by investing activities ​ ( 474 ) 14,208 FINANCING ACTIVITIES: ​ Proceeds from public offering or private placement with warrants, net of offering costs ​ ​ 12,390 ​ ​ 10,085 Proceeds (repayments) of long-term debt ​ ( 2,000 ) ( 1,955 ) Proceeds from exercises of Common Warrants and Prefunded Warrants ​ ​ 15,725 ​ ​ — Payments on revenue interest obligation ​ ( 7,400 ) — Proceeds from insurance premium financings ​ ​ 1,400 ​ ​ 1,995 Repayments of insurance premium financings ​ ​ ( 1,995 ) ​ ​ ( 472 ) Payments for taxes upon vesting of restricted stock units ​ ​ ( 1,188 ) ​ ​ ( 32 ) Proceeds from stock option exercises and issuance of common stock under ESPP ​ 162 219 Net cash provided by financing activities ​ 17,094 9,840 ​ ​ ​ ​ ​ ​ ​ Net (decrease) increase in cash ​ ( 6,037 ) 2,287 ​ ​ ​ ​ ​ ​ ​ Cash and cash equivalents, beginning of year ​ 19,276 16,989 Cash and cash equivalents, end of year ​ $ 13,239 $ 19,276 ​ ​ ​ ​ ​ ​ ​ Supplemental Cash Flow and Non-Cash Financing Activities Disclosures: ​ Cash paid for interest ​ $ 5,288 $ 2,321 Fair value of warrants issued ​ $ 2,464 ​ $ 12,760 Operating lease right-of-use asset extensions executed, net of early terminations ​ $ 1,141 ​ $ — Conversion of Common Warrants and Prefunded Warrants to common stock ​ $ 19,584 ​ $ — ​ The accompanying notes are an integral part of these consolidated financial statements. ​ F-6 Table of Contents ELUTIA INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1. Organization and Description of Business Elutia Inc. (together with its consolidated subsidiaries, "Elutia” or the “Company”) is a commercial-stage company leveraging its unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. The Company has developed a portfolio of products using both human and porcine tissue that are designed to be as close to natural biological material as possible. Elutia’s portfolio of products spans the Device Protection, Women’s Health and Cardiovascular markets. These products are primarily sold to healthcare providers or commercial partners. Note 2. Summary of Significant Accounting Policies Basis of Presentation and Liquidity The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. Intercompany accounts and transactions have been eliminated in consolidation. On November 8, 2023, the Company completed the sale of substantially all of the assets relating to its Orthobiologics segment (the “Orthobiologics Business”) to Berkeley Biologics, LLC (“Berkeley”). The Orthobiologics Business was comprised of assets relating to researching, developing, administering, insuring, operating, commercializing, manufacturing, selling and marketing the Company’s Orthobiologics products, and the business of contract manufacturing of particulate bone, precision milled bone, cellular bone matrix, acellular dermis, soft tissue and other products. The assets sold represent the entirety of the Company’s Orthobiologics segment. In the sale, the Company received $ 14.6 million, and the Company may earn up to an additional $ 20 million, in the aggregate, in the form of earn-out payments. The earn-out payments are equal to 10 % of the actual revenue earned by Berkeley in each of the five years after the closing of the sale from sales of specified Orthobiologics products under the purchase agreement (including improvements, modifications, derivatives and enhancements related to those products). There have been no earn-out payments made to date. Additionally, the purchase agreement provides for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after close. In the purchase agreement, the Company has retained the liabilities arising out of the VBM and FiberCel matters, as described in Note 17, both of which products were part of the Orthobiologics Business. The Company recognized a gain of $ 6.0 million on the sale of the Orthobiologics Business during the year ended December 31, 2023 and an additional gain of $ 0.2 million during the year ended December 31, 2024 from an adjustment payment related to the final working capital received by Berkeley at the sale date. The indemnity holdback is available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback may be retained by Berkeley if Berkeley is successful in asserting a claim or claims for indemnification against the Company. The Company is aware of certain indemnity-related claims raised, including a claim from a former supplier alleging breach of contract. Based on the Company’s ongoing assessment of these claims, along with the remaining indemnity holdback of $ 1.5 million, the Company does not consider a loss to be probable or estimable as of December 31, 2024. Should the Company receive incremental proceeds in the future through an earn-out payment or payment of the holdback amount, an additional gain will be recorded upon the receipt of such amounts. See Note 4 for further discussion of the sale of the Orthobiologics Business and the presentation of such business as discontinued operations for the year ended December 31, 2023. Unless indicated otherwise, the information in the notes to consolidated financial statements for the year ended December 31, 2023 relates to continuing operations. ​ In accordance with Accounting Standards Update (“ASU”) 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40) , the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. For the year ended F-7 Table of Contents December 31, 2024, the Company incurred a net loss of $ 53.9 million, and as of December 31, 2024, the Company had an accumulated deficit of $ 229.6 million. In addition, during the year ended December 31, 2024, the Company used $ 22.7 million of cash in operating activities and expects to continue to incur cash outflows in 2025. Because of the numerous risks and uncertainties associated with the Company’s commercialization and development efforts, the Company is unable to predict when it will become profitable, and it may never become profitable. The Company’s inability to achieve and then maintain profitability would negatively affect its business, financial condition, results of operations and cash flows. Furthermore, even if the Company does achieve profitability, it may not be able to sustain or increase profitability on an ongoing basis, or, in general, be able to satisfy its obligations, including those related to the FiberCel Litigation and VBM Litigation described in Note 17, when they become due. ​ In order to mitigate the current and potential future liquidity issues caused by the matters noted above, we may seek to raise capital through the issuance of common stock or pursue asset sales or other transactions, such as the sale of the Orthobiologics Business described above. However, such transactions may not be successful, and we may not be able to raise additional equity, refinance our debt instruments, or sell assets on acceptable terms, or at all. As such, based on our current operating plans, we believe there is uncertainty as to whether our future cash flows along with our existing cash, issuances of additional equity and cash generated from expected future sales will be sufficient to meet our anticipated operating needs through twelve months from the consolidated financial statement issuance date. Due to these factors, there is substantial doubt about our ability to continue as a going concern within one year after the issuance of the consolidated financial statements. ​ The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. That is, the accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. ​ Reclassifications A reclassification has been made to prior year amounts to conform to current year financial statement presentation and had no impact on previously reported results. The reclassification relates to the separate presentation of the prior year loss on revaluation of warrant liability. Such loss was formerly shown as a component of other (income) expense, net in the accompanying consolidated statements of operations. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates and assumptions relating to inventories, receivables, long-lived assets, the valuation of stock-based awards, the valuation of the revenue interest obligation, the valuation of the warrant liability, the contingent liabilities for legal proceedings and deferred income taxes are made at the end of each financial reporting period by management. Management continually re-evaluates its estimates, judgments and assumptions, and management's evaluation could change. Actual results could differ from those estimates. Net Loss per Share Attributable to Common Stockholders Our common stock has a dual class structure, consisting of Class A common stock, $ 0.001 par value per share (the “Class A common stock”) and Class B common stock, $ 0.001 par value per share (the “Class B common stock”). Other than voting rights, the Class B common stock has the same rights as the Class A common stock, and therefore both are treated as the same class of stock for purposes of the earnings per share calculation. The Company is also authorized to issue up to 10,000,000 shares of preferred stock with a par value of $ .001 . No shares have been issued or are outstanding as of December 31, 2024 and December 31, 2023. Basic net income per share is computed by dividing net income available to each class of shares by the weighted-average number of shares of common stock and participating securities outstanding during the period. Participating securities include common and prefunded warrants. Net loss is not allocated to participating securities as they do not have F-8 Table of Contents an obligation to fund losses. For purposes of the diluted net income per share attributable to common stockholders calculation, stock options, restricted stock units (“RSUs”) and warrants are considered to be common stock equivalents. See Note 16 for further discussion of net loss per share attributable to common stockholders. Fair Value of Financial Instruments Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value: Level 1 -   Valuations based on quoted prices for identical assets and liabilities in active markets. Level 2 -   Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data. Level 3 -   Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment. The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature. Cash and Cash Equivalents The Company maintains its cash and cash equivalent balances at banks and financial institutions. The balances are insured up to the legal limit. The Company maintains cash and cash equivalent balances that may, at times, exceed this insured limit. The Company considers cash on hand, demand deposits in a bank, money market funds, and all highly liquid investments with an original maturity of 90 days or less to be cash and cash equivalents. ​ Accounts Receivable and Allowances ​ Accounts receivable in the accompanying balance sheets are presented net of allowances for credit losses. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables. The Company evaluates the collectability of accounts receivable based on a combination of factors. In circumstances where a specific customer is unable to meet its financial obligations to the Company, a provision to the allowance for doubtful accounts is recorded to reduce the net recognized receivable to the amount that is reasonably expected to be collected. For all other customers, a provision to the allowance for credit losses is recorded based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. Provisions to the allowance for doubtful accounts are recorded to general and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered. The Company's allowance for doubtful accounts was approximately $ 0.6 million and $ 0.7 million as of December 31, 2024 and 2023, respectively. Inventories Inventory, consisting of purchased materials, direct labor and manufacturing overhead, is stated at the lower of cost or net realizable value, with cost determined generally using the average cost method. At each balance sheet date, the Company also evaluates inventory for excess quantities, obsolescence or shelf-life expiration. This evaluation includes an analysis of the Company’s current and future strategic plans, historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products, general market conditions and a review of the F-9 Table of Contents shelf-life expiration dates for products. To the extent that management determines there is excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to the estimated net realizable value. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed on the straight-line method over the following estimated useful lives of the assets: ​ ​ ​ ​ Processing and research equipment 5 to 10 years Office equipment and furniture 3 to 5 years Computer hardware and software 3 years ​ Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the asset. Repairs and maintenance costs are expensed as incurred. Leases In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No 2016-02, Leases to increase the transparency and comparability about leases among entities. ASU 2016-02 and certain additional ASUs are now codified as ASC 842, Leases . ASC 842 supersedes the lease accounting guidance in ASC 840 and requires lessees to recognize a lease liability and a corresponding lease asset for virtually all lease contracts. The Company determines if an arrangement contains a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from that lease. For leases with a term greater than 12 months, ROU assets and liabilities are recognized at the lease commencement date based on the estimated present value of lease payments over the lease term. The lease term includes the option to extend the lease when it is reasonably certain the Company will exercise that option. When available, the Company uses the rate implicit in the lease to discount lease payments to present value. In the case the implicit rate is not available, the Company uses its incremental borrowing rate based on information available at the lease commencement date, including publicly available data for instruments with similar characteristics, to determine the present value of lease payments. The Company combines lease and non-lease elements for office leases. Long-Lived Assets Purchased intangible assets with finite lives are carried at acquired fair value, less accumulated amortization. Amortization is recorded over the estimated useful lives of the respective assets. The Company periodically evaluates the period of depreciation or amortization for long-lived assets to determine whether current circumstances warrant revised estimates of useful lives. The Company reviews its property and equipment and intangible assets for impairment whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Impairment exists when the carrying value of the company’s asset exceeds the related estimated undiscounted future cash flows expected to be derived from the asset. If impairment exists, the carrying value of that asset is adjusted to its fair value. A discounted cash flow analysis is used to estimate an asset’s fair value, using assumptions that market participants would apply. The results of impairment tests are subject to management’s estimates and assumptions of projected cash flows and operating results. Changes in assumptions or market conditions could result in a change in estimated future cash flows and could result in a lower fair value and therefore an impairment, which could impact reported results. There were no impairment losses for the years ended December 31, 2024 and 2023. Warrant Liability The Company accounts for its warrants in accordance with ASC 815, Derivatives and Hedging – Contracts in Entity's Own Equity , as either liabilities or as equity instruments depending on the specific terms of the warrant agreement. The warrants issued in connection with the September 2023 private placement and June 2024 registered direct offering (see Note 14) are classified as liabilities and are recorded at fair value. The warrants are subject to re-measurement at each F-10 Table of Contents settlement date and at each balance sheet date and any change in fair value is recognized in other (income) expense, net in the consolidated statements of operations. The Company estimates the fair value of the warrant liability using a Black-Scholes pricing model. We are required to make assumptions and estimates in determining an appropriate term, risk-free interest rate, volatility factor, dividend yield, and the fair value of common stock. Any significant adjustments to the unobservable inputs would have a direct impact on the fair value of the warrant liability. Revenue Recognition The Company’s revenue is generated from contracts with customers in accordance with ASC 606. The core principle of ASC 606 is that the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The ASC 606 revenue recognition model consists of the following five steps: (1) identify the contracts with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation. As noted above, the Company enters into contracts to primarily sell and distribute products to healthcare providers or commercial partners. Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products to the Company’s customers. For all product sales, the Company has no further performance obligations and revenue is recognized at the point control transfers which occurs either when: i) the product is shipped via common carrier; or ii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement. A portion of the Company’s product revenue is generated from consigned inventory maintained at hospitals and from inventory physically held by distributors and direct sales representatives. For these types of product sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized. The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in sales and marketing costs. Shipping and handling costs were not material in both the years ended December 31, 2024 and 2023. Contracts with customers state the final terms of the sale, including the description, quantity, and price of each implant distributed. The payment terms and conditions in the Company’s contracts vary; however, as a common business practice, payment terms are typically due in full within 30 to 60 days of delivery. The Company, at times, extends volume discounts to customers. The Company permits returns of its products in accordance with the terms of contractual agreements with customers. Allowances for returns are provided based upon analysis of the Company’s historical patterns of returns matched against the revenues from which they originated. The Company records estimated returns as a reduction of revenue in the same period revenue is recognized. Stock-Based Compensation Plans The Company accounts for its stock-based compensation plans in accordance with FASB Accounting Standards Codification (“ASC”) 718, Accounting for Stock Compensation . ASC 718 requires the measurement and recognition of compensation expense for all stock-based awards made to employees and directors, including employee stock options and restricted stock units. Stock-based compensation cost is measured at the grant date, based on the calculated fair value of the award, and is recognized as an expense on a straight-line basis over the requisite service period of the entire award. F-11 Table of Contents Research and Development Costs Research and development costs, which include mainly salaries, outside services and supplies, are expensed as incurred. Concentration of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash. The Company’s cash balances with the individual institutions may at times exceed the federally insured limits. During the year ended December 31, 2024, there was one customer that represented 15 % of the Company’s net sales in such year, and during the year ended December 31, 2023, there was one customer that represented 10 % of the Company’s sales in such year. There was one customer that represented 14 % of the Company’s accounts receivable as of December 31, 2024, and there was one customer that represented 31 % of the Company’s accounts receivable as of December 31, 2023. ​ Comprehensive Income (Loss) Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the years ended December 31, 2024 and 2023, the Company’s net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences on future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized. The Company is subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more likely than not (greater than 50%) of being realized upon settlement. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. ​ ​ Note 3. Recently Issued Accounting Standards In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This update improves reportable segment disclosure requirements, primarily through enhanced disclosures of significant segment expenses. The amendments in this update should be applied retrospectively to all prior periods presented in the consolidated financial statements and are effective for fiscal years beginning after December 31, 2023 and interim periods within fiscal years beginning after December 31, 2024. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements; however, the Company has expanded its disclosures in Note 18, Segment Information. ​ In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures. This update improves income tax disclosure requirements, primarily through enhanced transparency and decision usefulness of disclosures. The amendments in this update should be applied prospectively with the option to apply retrospectively and are effective for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company does not expect the adoption of this guidance to have any material effects on its financial condition, results of F-12 Table of Contents operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09. In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220-40). This update assesses the disaggregation of income statement expense which requires more detailed information about specified categories of expenses included in certain expense captions presented on the face of the income statement. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2024-03. Note 4. Sale of Orthobiologics Business As described in Note 2, on November 8, 2023, the Company completed the sale of its Orthobiologics Business. Accordingly, the Orthobiologics Business is reported as discontinued operations in accordance with ASC 205-20 - Discontinued Operations and the amounts for the years ended December 31, 2023 have been recast to conform to this discontinued operations presentation. ​ In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed may be presented in discontinued operations. The following table shows the financial results of the discontinued operations from January 1, 2023 through the transaction closing date of November 8, 2023. Additionally, a gain of $ 0.2 million was recognized during the year ended December 31, 2024 related to the final working capital adjustment received from Berkeley. ​ ​ ​ ​ Net sales $ 14,913 Cost of goods sold 12,682 Gross profit 2,231 Sales and marketing 1,784 General and administrative 1,534 Research and development 951 Total operating expenses ​ 4,269 Interest Expense ​ 348 Net income (loss) $ ( 2,386 ) ​ Total operating and investing cash flows of discontinued operations from January 1, 2023 through the transaction closing date of November 8, 2023 are comprised of the following: ​ ​ ​ ​ Significant operating non-cash reconciliation items: Depreciation $ 239 Stock-based compensation ​ 86 Changes in operating assets and liabilities: ​ ​ Accounts receivable ​ 882 Inventory 988 Prepaid expenses and other ( 449 ) Accounts payable and accrued expenses and other current liabilities ( 1,562 ) Obligations to tissue suppliers ( 691 ) ​ ​ ​ Significant investing items: ​ ​ Expenditures for property, plant and equipment ( 225 ) ​ ​ F-13 Table of Contents Note 5. Stock-Based Compensation In 2015, the Company established the Elutia Inc. 2015 Stock Option/Stock Issuance Plan, as amended (the “2015 Plan”) which provided for the granting of incentive and non-qualified stock options to employees, directors and consultants of the Company. On October 7, 2020, in connection with the Company’s IPO, the Company adopted the Elutia Inc. 2020 Incentive Award Plan, and on June 8, 2023, the Company’s stockholders approved the amendment and restatement of that plan (as amended and restated, the “2020 Plan”), which authorizes the grant of incentive and non-qualified stock options, restricted stock, restricted stock units and stock appreciation rights to employees, directors and consultants. Shares of Class A common stock totaling 1,636,000 were initially reserved for issuance pursuant to the 2020 Plan, and in June 2023, the number of shares of Class A common stock reserved for issuance under the 2020 Plan was increased by 2,000,000 shares. In addition, the shares reserved for issuance under the 2020 Plan also include shares reserved but not issued under the 2015 Plan as well as an annual increase as set forth in the 2020 Plan. As of December 31, 2024, the Company had 396,561 shares of Class A common stock available for issuance under the 2020 Plan, and on January 1, 2025, the shares available for issuance were increased by 1,408,426 pursuant to the automatic increase provisions of the plan. Stock Options ​ The Company’s policy is to grant stock options at an exercise price equal to 100 % of the market value of a share of Class A common stock at closing on the date of the grant. The Company’s stock options have contractual terms of ten years and generally vest over a four-year period from the date of grant. ​ A summary of stock option activity under the Company’s 2015 Plan and 2020 Plan for the years ended December 31, 2024 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Average ​ ​ ​ ​ ​ ​ Weighted- ​ Remaining ​ Aggregate ​ ​ ​ ​ Average ​ Contractual ​ Intrinsic ​ ​ Exercise Term Value ​ ​ Number of Shares ​ Price ​ (years) ​ (in thousands) Outstanding, December 31, 2023 ​ 1,501,193 ​ $ 8.37 ​ ​ 7.8 $ - Granted ​ 1,790,654 ​ $ 3.59 ​ ​ ​ ​ ​ ​ Exercised ​ ( 1,960 ) ​ $ 3.61 ​ ​ ​ ​ ​ ​ Forfeited ​ ( 68,896 ) ​ $ 9.39 ​ ​ ​ ​ ​ ​ Outstanding, December 31, 2024 ​ 3,220,991 ​ $ 5.23 ​ ​ 7.3 ​ $ 475 Vested and exercisable, December 31, 2024 ​ 1,806,344 ​ $ 5.98 ​ ​ 6.1 ​ $ 301 ​ As of December 31, 2024, there was approximately $ 3.2 million of total unrecognized compensation expense related to unvested stock options. These costs are expected to be recognized over a weighted-average period of 1.8 years. The weighted average grant date fair value of options granted during the years ended December 31, 2024 and 2023 were $ 2.38 and $ 1.63 , respectively. The total intrinsic value of options exercised was not material for both the years ended December 31, 2024 and 2023. The Company uses the Black-Scholes model to value its stock option grants that vest based on the passage of time or the achievement of certain performance criteria and expenses the related compensation cost using the straight-line method over the vesting period. The fair value of stock options is determined on the grant date using assumptions for the estimated fair value of the underlying common stock, expected term, expected volatility, dividend yield, and the risk-free interest rate. The Company uses the simplified method for estimating the expected term used to determine the fair value of options. The expected volatility of the Class A common stock is based on the Company’s historical stock data. The Company uses a zero -dividend yield assumption as the Company has not paid dividends since inception nor does it anticipate paying dividends in the future. The risk-free interest rate approximates recent U.S. Treasury note auction results with a similar life to that of the option. The period expense is then determined based on the valuation of the options and is recognized on a straight-line basis over the requisite service period for the entire award. F-14 Table of Contents The following weighted-average assumptions were used to determine the fair value of options during the years ended December 31, 2024 and 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ ​ December 31, ​ ​ 2024 2023 ​ Expected term (years) ​ 5.9 ​ 6.0 ​ Risk-free interest rate ​ 3.3 % 3.9 % Volatility factor ​ 84.2 % 63.8 % Dividend yield ​ — ​ — ​ ​ In January 2024, the Company granted 390,625 options that vested on a defined date following the U.S. Food and Drug Administration’s (“FDA”) clearance of the Company’s EluPro product (referred to as CanGarooRM during development) product. With the FDA’s approval of EluPro in June 2024, such vesting occurred in August 2024. Consistent with the above, these performance vesting options were valued using the Black-Scholes model. During the year ended December 31, 2024, the Company also granted 162,500 stock options that vest in equal installments upon the achievement of certain share price thresholds for twenty consecutive days of trading at each respective threshold. For these stock options, the Company accounted for the awards as market condition awards and used an option pricing model, the Monte Carlo model, to determine the fair value of the respective equity instruments and an expense recognition term of approximately three years . As of December 31, 2024, there were a total of 345,011 stock options outstanding that are market condition stock option awards. ​ Restricted Stock Units ​ Restricted stock units (“RSUs”) represent rights to receive common shares at a future date. There is no exercise price and no monetary payment is required for receipt of restricted stock units or the shares issued in settlement of the award. A summary of the RSU activity under the Company’s 2020 Plan for the year ended December 31, 2024 is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Average ​ ​ Number of Shares ​ Grant Date ​ ​ Underlying RSUs ​ Fair Value Unvested, December 31, 2023 335,608 ​ $ 3.64 Granted 2,377,500 ​ $ 3.58 Vested ( 1,129,748 ) ​ $ 3.68 Forfeited ( 166,237 ) ​ $ 3.03 Unvested, December 31, 2024 1,417,123 ​ $ 3.58 ​ The total fair value of the RSUs granted during the years ended December 31, 2024 and 2023 was $ 8.5 million and $ 0.3 million, respectively. For the performance vesting RSUs, the fair value was based on the fair market value of the Company's Class A common stock on the date of grant. The market condition RSUs are valued as described below. The respective fair values are amortized to expense on a straight-line basis over the vesting period of generally three to four years . As of December 31, 2024, $ 4.4 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of 2.0 years. During the year ended December 31, 2024, the Company granted 554,375 RSUs that vested on a defined date following the FDA’s clearance of the Company’s EluPro product. With the FDA’s approval of EluPro in June 2024, such vesting occurred in August 2024. These performance vesting RSUs were valued using the fair value of the Company’s Class A common stock on the date of grant. The Company has also granted 162,500 RSUs that vest in equal installments upon the achievement of certain share price thresholds for twenty consecutive days of trading at each respective threshold. For these RSUs, the Company accounted for the awards as market condition awards and used a Monte Carlo model to F-15 Table of Contents determine the fair value of these RSUs as well as the expense recognition term of approximately three years using the graded vesting method. As of December 31, 2024, there were 252,394 RSUs outstanding that were market condition RSU awards. ​ Employee Stock Purchase Plan The Company makes shares of its Class A common stock available for purchase under the Elutia Inc. 2020 Employee Stock Purchase Plan (the “ESPP”). The ESPP provides for separate six-month offering periods that begin in March and September of each year. Under the ESPP, employees may purchase a limited number of shares of Elutia Class A common stock at 85 % of the fair market value on either the first day of the offering period or the purchase date, whichever is lower. The ESPP is considered compensatory for purposes of stock-based compensation expense. The number of shares reserved under the ESPP will automatically increase on the first day of each fiscal year through January 1, 2030, in an amount as set forth in the ESPP. As of December 31, 2024, the total shares of Class A common stock authorized for issuance under the ESPP was 774,341 , of which 471,126 remained available for future issuance. During the year ended December 31, 2024, 96,658 shares of Class A common stock were issued under the ESPP. Stock-Based Compensation Expense Stock-based compensation expense recognized during the years ended December 31, 2024 and 2023 comprised of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 Sales and marketing ​ $ 1,475 $ 569 General and administrative ​ 5,281 ​ 1,607 Research and development ​ 964 ​ 122 Cost of goods sold ​ 171 ​ 107 Total stock-based compensation expense ​ $ 7,891 ​ $ 2,405 ​ ​ Note 6. Inventory Inventory as of December 31, 2024 and 2023 was comprised of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 Raw materials ​ $ 440 ​ $ 242 Work in process ​ ​ 740 ​ ​ 286 Finished goods ​ ​ 2,731 ​ ​ 3,325 Total ​ $ 3,911 ​ $ 3,853 ​ ​ Note 7. Property and Equipment ​ Property and equipment as of December 31, 2024 and 2023 were comprised of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 Processing and research equipment ​ $ 1,023 ​ $ 381 Leasehold improvements ​ 103 ​ 92 Office equipment and furniture ​ 87 ​ 86 Computer hardware and software ​ 194 ​ 194 ​ ​ 1,407 ​ 753 Less: accumulated depreciation and amortization ​ ( 634 ) ​ ( 581 ) Property and equipment, net ​ $ 773 ​ $ 172 F-16 Table of Contents ​ Depreciation and amortization expense on property and equipment totaled approximately $ 0.1 million in both of the years ended December 31, 2024 and 2023. Amounts included within cost of goods sold are not material. ​ Note 8. Leases ​ As of December 31, 2024, the Company leases one production facility, one administrative and research facility and one administrative facility under non-cancelable operating lease arrangements that expire through October 2026. ​ The following is a summary of the Company’s ROU assets and operating lease liabilities as of December 31, 2024 and 2023 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ ​ Classification on the Balance Sheet 2024 2023 ​ Assets ​ ​ ​ ​ ​ ​ ​ Operating leases assets Operating lease right-of-use assets and other $ 860 ​ $ 271 ​ ​ ​ ​ ​ ​ ​ ​ Liabilities ​ ​ ​ ​ ​ ​ ​ Operating leases current liabilities Current operating lease liabilities and other ​ 460 ​ ​ 275 ​ Operating leases non-current liabilities Long-term operating lease liabilities ​ 423 ​ ​ — ​ Total lease liabilities ​ $ 883 ​ $ 275 ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted average remaining lease term ​ ​ 1.7 ​ ​ 0.6 ​ Weighted average discount rate ​ ​ 13.1 % ​ 7.2 % ​ For the years ended December 31, 2024 and 2023, the Company recognized operating lease costs of approximately $ 0.6 million and $ 0.5 million, respectively. Cash paid for amounts included in the measurement of operating lease liabilities are included in operating cash flows and were approximately $ 0.6 million for both the years ended December 31, 2024 and 2023. ​ The table below reconciles the Company’s future cash obligations to the operating lease liabilities recorded on the balance sheet as of December 31, 2024 (in thousands): ​ ​ ​ ​ ​ Years ending December 31, ​ 2025 ​ $ 546 2026 ​ 454 Total minimum lease payments ​ ​ 1,000 Less: amount of lease payments representing interest ​ ​ ( 117 ) Present value of future minimum lease payments ​ ​ 883 Less: current operating lease liabilities ​ ​ ( 460 ) Long-term operating lease liabilities ​ $ 423 ​ In March 2025, the Company signed a new lease for 26,598 square feet. This new facility will be utilized for office, manufacturing and laboratory space. The lease expires in January 2036 with early termination dates in 2029 and 2033. Monthly lease payments (including allocation portions of property taxes, insurance and other landlord operating expenses) total approximately $ 75,000 with annual rent escalations of 3 %. Rent is abated for the first 12 months of occupancy and is discounted at 50 % for months 18 through 24. ​ ​ Note 9. Intangible Assets ​ On May 31, 2017, the Company completed an asset purchase agreement with CorMatrix Cardiovascular, Inc. (“CorMatrix”) and acquired all CorMatrix commercial assets and related intellectual property. A substantial portion of the assets acquired consisted of intangible assets related to the acquired products and customer relationships. Management F-17 Table of Contents determined that the estimated acquisition-date fair values of the intangible assets related to acquired products and customer relationships were $ 29.3 million and $ 4.7 million, respectively. ​ The components of identified intangible assets as of December 31, 2024 and 2023 are as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2024 December 31, 2023 ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ Cost Amortization Net Cost Amortization Net Acquired products ​ $ 29,317 ​ $ ( 22,186 ) ​ $ 7,131 ​ $ 29,317 ​ $ ( 19,260 ) ​ $ 10,057 Customer relationships ​ ​ 4,723 ​ ​ ( 3,581 ) ​ ​ 1,142 ​ 4,723 ​ ​ ( 3,109 ) ​ ​ 1,614 Total ​ $ 34,040 ​ $ ( 25,767 ) ​ $ 8,273 ​ $ 34,040 ​ $ ( 22,369 ) ​ $ 11,671 ​ Acquired products and customer relationships are both amortized over a ten-year period. Amortization expense totaled approximately $ 3.4 million for each of the years ended December 31, 2024 and 2023, which is included in cost of goods sold in the accompanying consolidated statements of operations. Annual amortization expense is expected to be approximately $ 3.4 million during the years ended December 31, 2024 through 2026 and approximately $ 1.5 million during the year ended December 31, 2027. ​ Note 10. Long-Term Debt O n August 10, 2022, the Company entered into a senior secured term loan facility with SWK Funding LLC, as agent, and other lenders party thereto for an aggregate principal amount of $ 25 million, and the Company amended the facility in May 2023, March 2024 and September 2024 (as amended, the “SWK Loan Facility”). An initial draw of $ 21 million was made in August 2022, and an additional $ 4 million was made on December 14, 2022. The SWK Loan Facility also allows for the establishment of a separate, new asset-based revolving loan facility of up to $ 8 million, which has not been entered into to date. The SWK Loan Facility matures on August 10, 2027 and accrues interest, payable quarterly in arrears. Principal amortization of the SWK Loan Facility, as amended in September 2024, starts in November 2025. Principal payments during the amortization period will be limited based on revenue-based caps, although as of December 31, 2024, no such caps are applicable and quarterly principal payments will be in an amount equal to 5 % of the aggregate principal amount funded with the balance paid at maturity. T he SWK Loan Facility also includes both revenue and liquidity covenants, restrictions as to payment of dividends, and is secured by all assets of the Company, subject to certain customary exceptions. As of December 31, 2024, Elutia was in compliance with its financial covenants under the agreement governing the SWK Loan Facility (“SWK Loan Facility Agreement”). All of the SWK Loan Facility borrowings take the form of Secured Overnight Financing Rate (“SOFR”) loans and bear interest at a rate per annum equal to the sum of an applicable margin of (i) 7.75 % and the “Term SOFR Rate” (based upon an interest period of 3 months), or (ii) if the Company has elected the PIK Interest option (as defined below), 3.75 % and the “Term SOFR Rate.” The Company may elect a portion of the interest due, to be paid in-kind at a rate per annum of 4.5 % (“PIK Interest”), and such election may be made until November 15, 2025. The “Term SOFR Rate” is subject to a floor of 2.75 %. The agreement governing the SWK Loan Facility also includes an exit fee equal to 6.5 % of the aggregate principal amount funded prior to termination plus $ 112,500 . The weighted average interest rate on the SWK Loan Facility was 13.4 % and 13.2 % for the years ended December 31, 2024 and 2023, respectively. The Company elected the PIK interest option for all four quarters of both 2024 and 2023. ​ On August 10, 2022, the Company issued to SWK Funding LLC a warrant (“Class A Warrant”) to purchase, in the aggregate, up to 187,969 shares of Class A common stock of the Company, $ 0.001 par value per share at an exercise price of $ 6.65 per share. The Class A Warrant is immediately exercisable for up to 187,969 shares of Class A common stock from time to time on or after the Closing Date. The exercise price and number of shares of Class A common stock issuable upon exercise of the Class A Warrant are subject to adjustment in the event of stock dividends, stock splits and certain other events affecting the Class A common stock. Unless earlier exercised or terminated in accordance with its terms, the Class A Warrant will expire on the seventh anniversary of the Closing Date. Upon issuance, the Company valued the Class A Warrant at approximately $ 0.6 million using the Black-Scholes model. The recognition of the Class A Warrant as well as deferred financing costs of approximately $ 0.5 million incurred in securing the SWK Loan Facility F-18 Table of Contents served to reduce the recorded value of the associated debt. The debt discount and deferred financing costs will be recognized as interest expense through the maturity of the loan. ​ The SWK Loan Facility Agreement requires certain mandatory prepayments, subject to certain exceptions, with: (1) 100 % of any net casualty proceeds in excess of $ 250,000 and (2) for non-ordinary course asset sales, an amount equal to the difference between (x) the proportion of divested gross profit (as defined in the SWK Loan Facility Agreement) to the Company’s total gross profit (as defined in the SWK Loan Facility Agreement) multiplied by the outstanding loans under the SWK Loan Facility and (y) the difference between $ 1,000,000 and the aggregate sale proceeds of any assets previously sold during the fiscal year. The closing of the divestiture of the Orthobiologics Business in November 2023 triggered the mandatory prepayment of $ 4.0 million. Of such amount, $ 2.0 million wa s paid shortly after closing of the divestiture in 2023 and the remainder was paid in February 2024 based on mutual agreement between the parties. ​ As noted above, the Company executed an amendment to the SWK Loan Facility in September 2024 which, among other items, served to defer the commencement of principal repayment from November 2024 to November 2025. ​ As of December 31, 2024, the contractual maturities of the long-term debt are as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ Years ending December 31, Term Loan 2025 ​ $ 1,250 2026 ​ 5,000 2027 ​ 17,275 Total ​ 23,525 Debt Discount ​ ( 318 ) Deferred Financing Costs ​ ( 244 ) Exit Fee Liability ​ ​ 890 Total, net ​ 23,853 Current Portion ​ ( 1,250 ) Long-term Debt ​ $ 22,603 ​ In addition to the above, the Company finances the annual premiums of certain insurance policies through short-term financing arrangements and includes the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheets. The fair value of all debt instruments, which is based on inputs considered to be Level 2 under the fair value hierarchy, approximates the respective carrying values as of December 31, 2024 and 2023. Note 11. Revenue Interest Obligation As part of the CorMatrix asset acquisition described in Note 9, the Company assumed a restructured, long-term obligation (the “Initial Revenue Interest Obligation”) to Ligand Pharmaceuticals (“Ligand”) with an estimated present value on the acquisition date of $ 27.7 million. Subject to annual minimum payments of $ 2.75 million per year, the terms of the Initial Revenue Interest Obligation require Elutia to pay Ligand, 5 % of future sales of the products Elutia acquired from CorMatrix, including CanGaroo, ProxiCor, Tyke and VasCure, as well as products substantially similar to those products, such as EluPro. Furthermore, a $ 5.0 million payment would be due to Ligand if cumulative sales of these products exceed $ 100 million and a second $ 5.0 million will be due if cumulative sales exceed $ 300 million or the assets related to CanGaroo and any substantially similar products undergo a change of control during the ten-year term of the agreement which expires on May 31, 2027. On January 10, 2024, the Company entered into an amendment to the Revenue Interest Obligation (the “Amended Revenue Interest Obligation”). Pursuant to the Amended Revenue Interest Obligation, the parties modified and restructured the Revenue Interest Obligation by revising the annual minimum payments for 2024 and each subsequent fiscal year during the term of the agreement from $ 2.75 million to $ 4.4 million. Such minimums are payable quarterly within 30 days after each quarter-end date. Additionally, the Company made payments totaling $ 3.0 million ( 50 % paid in January 2024 and 50 % paid in April 2024) in satisfaction of all royalty obligations for the first three fiscal quarters of 2023 and made a payment in February 2024 of $ 1.1 million in satisfaction of the royalty obligations for the fourth quarter F-19 Table of Contents of 2023. Furthermore, as part of the Amended Revenue Interest Obligation, Ligand waived the Company’s obligation to make the $ 5.0 million milestone payment that became due to Ligand in the second quarter of 2023. ​ The Company has estimated the value of the Initial Revenue Interest Obligation as of December 31, 2024 and 2023, including contingent milestone payments and estimated sales-based payments, based on assumptions related to future sales of the acquired products. At each reporting period, the value of the Revenue Interest Obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method. The Amended Revenue Interest Obligation changed the timing and extent of future payments by the Company to Ligand and such change to the estimated future payments yielded a reduction to the total obligation of approximately $ 1.4 million during the year ended December 31, 2024. The resulting gain was recognized as other income in the accompanying consolidated statement of operations. There was no change to estimated future payments during the year ended December 31, 2023, and thus, no re-measurement gain or loss was recognized. As of December 31, 2024, the short-term portion of the Amended Revenue Interest Obligation is comprised of the newly established annual minimum payments of $ 4.4 million. As of December 31, 2023, the short-term portion of the Initial Revenue Interest Obligation is comprised of (i) the 2023 and 2024 minimum payments, (ii) the first $ 5.0 million sales milestone payment noted above and (iii) the unpaid portion of the 2022 minimum payments. ​ Note 12. Fair Value Measurements The following tables set forth by level, within the fair value hierarchy, the liabilities that are measured at fair value on a recurring basis (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements at December 31, 2023 Using: ​ Level 1 Level 2 Level 3 Total Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market fund ​ $ 14,087 ​ $ — ​ $ — ​ $ 14,087 Total ​ $ 14,087 ​ $ — ​ $ — ​ $ 14,087 Liabilities: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue Interest Obligation* ​ $ — ​ $ — ​ $ 17,101 ​ $ 17,101 Warrant liability ​ ​ — ​ ​ — ​ ​ 12,760 ​ ​ 12,760 Total ​ $ — ​ $ — ​ $ 29,861 ​ $ 29,861 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Fair Value Measurements at December 31, 2024 Using: ​ Level 1 Level 2 Level 3 Total Assets: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Money market fund ​ $ 10,850 ​ $ — ​ $ — ​ $ 10,850 Total ​ $ 10,850 ​ $ — ​ $ — ​ $ 10,850 Liabilities: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Revenue Interest Obligation* ​ $ — ​ $ — ​ $ 9,890 ​ $ 9,890 Warrant liability ​ ​ — ​ ​ — ​ ​ 16,076 ​ ​ 16,076 Total ​ $ — ​ $ — ​ $ 25,966 ​ $ 25,966 *Net Present Value; see discussion of value below ​ The warrant liability in the table above consisted of the fair value of Common Warrants, 2023 Prefunded Warrants and 2024 Prefunded Warrants (as defined in Note 14 below) to purchase the Company’s Class A Common Stock and, with respect to the Common Warrants, was based on significant inputs not observable on the market, which represents a Level 3 measurement within the fair value hierarchy. See Note 14 for discussion of the Company’s valuation methods and related impacts on the consolidated statement of operations relative to the warrant liability. ​ See Note 11 for discussion of the fair valuation of the Company’s Revenue Interest Obligation. ​ F-20 Table of Contents The following table provides a rollforward of the aggregate fair value of the Revenue Interest Obligation categorized with a Level 3 input for the years ended December 31, 2024 and 2023 (in thousands): ​ ​ ​ ​ ​ Revenue Interest Obligation Balance, January 1, 2023 $ 14,906 Interest accrued to Revenue Interest Obligation ​ 2,195 Balance, December 31, 2023 $ 17,101 Payments on Revenue Interest Obligation ​ ( 7,400 ) Interest accrued to Revenue Interest Obligation ​ 1,632 Gain on revaluation of revenue interest obligation ​ ( 1,443 ) Balance, December 31, 2024 $ 9,890 ​ ​ See Note 14 for the rollforward of the aggregate fair value of the warrant liability. ​ Note 13. Income Taxes The Company is subject to income taxes in the United States. Income taxes are accounted for under the asset and liability method. Deferred income tax assets and liabilities are calculated based on the difference between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases using the enacted income tax rates expected to be in effect during the years in which the temporary differences are expected to reverse. The reconciliation of the U.S. federal statutory rate to the consolidated effective tax rate is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Years Ended December 31, ​ ​ 2024 ​ 2023 ​ Tax benefit at U.S. statutory rate ​ 21.0 % 21.0 % State income tax benefit, net of federal benefit 1.5 % 1.8 % Nondeductible expenses ​ ( 6.6 ) % ( 2.8 ) % State law changes ​ 0.2 % 0.6 % Other ​ ( 0.6 ) % ( 1.4 ) % Change in valuation allowance ​ ( 15.5 ) % ( 19.3 ) % Effective tax rate ​ — % ( 0.1 ) % ​ Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes as well as net operating loss F-21 Table of Contents carryforwards. As of December 31, 2024 and 2023, significant components of the Company’s net deferred income taxes are as follows (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 Deferred tax assets: ​ ​ ​ ​ ​ ​ Tax goodwill ​ $ 2,549 ​ $ 2,613 Net operating loss carryforwards ​ ​ 29,733 ​ ​ 23,325 Inventory ​ ​ 94 ​ ​ 137 Acquired intangibles ​ ​ 2,000 ​ ​ 1,734 Revenue interest obligation ​ ​ 631 ​ ​ 1,220 Interest expense ​ ​ 4,485 ​ ​ 3,510 Research and development costs ​ ​ 2,375 ​ ​ 2,412 Operating lease liability ​ ​ 193 ​ ​ 52 Litigation costs ​ ​ 3,713 ​ ​ 2,867 Other ​ ​ 2,262 ​ ​ 1,653 Total assets ​ ​ 48,035 ​ ​ 39,523 Deferred tax liabilities: ​ ​ ​ ​ ​ ​ Operating lease right-to-use assets ​ ​ ( 188 ) ​ ​ ( 51 ) Prepaid expenses ​ ​ ( 441 ) ​ ​ ( 484 ) Total liabilities ​ ​ ( 629 ) ​ ​ ( 535 ) ​ ​ ​ ​ ​ ​ ​ Total net deferred tax asset ​ ​ 47,406 ​ ​ 38,988 Valuation allowance ​ ​ ( 47,406 ) ​ ​ ( 38,988 ) Net deferred tax asset, net of valuation allowance ​ $ — ​ $ — ​ The Company did not recognize any deferred benefit for income taxes for the years ended December 31, 2024 and 2023, as the increases to the respective net deferred tax assets of $ 8.4 million and $ 7.1 million, respectively, were offset by corresponding increases to the Company’s deferred tax asset valuation allowance due to the uncertainty of realizing the deferred tax assets. The Company evaluates the need for deferred tax asset valuation allowances based on a more likely than not standard. The ability to realize deferred tax assets depends on the ability to generate sufficient taxable income within the carryback or carryforward periods provided for in the tax law for each applicable tax jurisdiction. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized. Based on the uncertainty of future taxable income generation, as of December 31, 2024 and 2023, the Company has provided valuation allowances against all deferred tax assets. The Company regularly assesses the realizability of its deferred tax assets. Changes in historical earnings performance and future earnings projections, among other factors, may cause the Company to adjust its valuation allowance, which would impact the Company’s income tax expense in the period the Company determines that these factors have changed. The income tax expense for the years ended December 31, 2024 and 2023 relates to current amounts due on certain state tax obligations. As of December 31, 2024, the Company had net operating loss carryforwards for federal income tax purposes of approximately $ 129.3 million, comprised of  $ 17.7 million that will expire beginning in 2036 and $ 111.6 million that have no expiration date. The Company also had state net operating loss carryforwards of approximately $ 46.9 million that will expire beginning in 2030. Utilization of the net operating loss carryforwards may be subject to an annual limitation under Section 382 of the Code, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant F-22 Table of Contents complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the net operating loss carryforwards would be subject to an annual limitation under Section 382. Any limitation may result in the expiration of a portion of the net operating loss carryforwards before utilization. As of December 31, 2024 and 2023, the Company had no unrecognized tax benefits. ​ Note 14. Common Stock and Warrants Registered Direct Offerings of Common Stock and Warrants ​ On June 16, 2024, the Company sold, in a registered direct offering (“2024 Registered Offering”) an aggregate of (i) 3,175,000 shares of the Company’s Class A common stock and (ii) prefunded warrants (“2024 Prefunded Warrants”) to purchase up to an aggregate of 725,000 shares of Class A Common Stock. The public offering price for each share of Class A Common Stock was $ 3.40 , and the public offering price for each 2024 Prefunded Warrant was $ 3.399 , for aggregate gross proceeds of approximately $ 13.3 million, before deducting offering expenses. The 2024 Prefunded Warrants have an exercise price of $ 0.001 per share of Class A Common Stock, are exercisable immediately and will expire when exercised in full. The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.4 million in connection with the Registered Offering, of which $ 1.1 million were allocated to the issuance of the common stock. ​ Subsequent to December 31, 2024, on February 4, 2025, the Company sold, in a registered direct offering (“2025 Registered Offering”) an aggregate of (i) 5,520,000 shares of our Class A common stock and (ii) prefunded warrants (“2025 Prefunded Warrants”) to purchase up to an aggregate of 480,000 shares of Class A Common Stock. The public offering price for each share of Class A Common Stock was $ 2.50 , and the public offering price for each 2025 Prefunded Warrant was $ 2.499 , for aggregate gross proceeds of approximately $ 15.0 million, before deducting offering expenses. The 2025 Prefunded Warrants have an exercise price of $ 0.001 per share of Class A Common Stock, are exercisable immediately and will expire when exercised in full. ​ Private Placement of Common Stock and Warrants ​ On September 21, 2023, the Company sold, in a private offering (“Private Offering”) an aggregate of (i) 6,852,811 units (“Common Units”) each comprised of (a) one share of the Company’s Class A common stock and (b) a warrant (“Common Warrant”) to purchase one and one half shares of Class A Common Stock, and (ii) 503,058 units (the “Prefunded Units”), each comprised of (a) a prefunded warrant (“2023 Prefunded Warrant”) to purchase one share of Class A Common Stock, and (b) a Common Warrant. The Common Units were sold at a purchase price of $ 1.4275 per unit, and the Prefunded Units were sold at a purchase price of $ 1.4265 per unit, for aggregate gross proceeds of approximately $ 10.5 million, before deducting offering expenses. Each Common Warrant was exercisable until July 31, 2024, the date which was 30 trading days after the clearance by the FDA of the Company’s EluPro product, at an exercise price per share of $ 1.4275 . As discussed below, all Common Warrants were exercised before they expired. Each 2023 Prefunded Warrant is exercisable at any time at a nominal exercise price per share of $ 0.001 (with the remainder of the exercise price per share of Class A Common Stock having been prefunded to the Company). The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.1 million in connection with the Private Offering, of which $ 0.4 million were allocated to the issuance of the common stock. ​ See below for discussion of the accounting for the warrants and the allocation of the remainder of the transaction fees from both the 2024 Registered Offering and Private Offering. ​ Warrant Liabilities ​ The Company has concluded that the 2024 Prefunded Warrants from the Registered Offering and the Common Warrants and the 2023 Prefunded Warrants from the Private Offering do not meet the equity contract scope exception under ASC 815-40 as in the event of a (i) fundamental transaction such as a merger and (ii) failure to timely deliver warrant F-23 Table of Contents shares upon exercise, certain provisions of which may require the Company to adjust the settlement value in a manner that is not consistent with a fixed-for-fixed option pricing model. ​ As a result, with respect to the 2024 Prefunded Warrants, the Company allocated $ 2.5 million of the gross proceeds from the Registered Offering to such warrants based on their fair value. Similarly, with respect to the Common Warrants and 2023 Prefunded Warrants, the Company allocated $ 8.6 million of the gross proceeds from the Private Offering to such warrants based on their fair value. Additionally, the Company allocated a portion of the transaction fees from both the Registered Offering and the Private Offering to the respective warrants and recognized the expense within other (income) expense, net. Such expenses totaled $ 0.3 million during the year ended December 31, 2024, and $ 0.8 million during the year ended December 31, 2023. ​ As noted above, the last exercise date for the Common Warrants was July 31, 2024. All Common Warrants outstanding were exercised by such date yielding exercise proceeds of $ 15.7 million during the year ended December 31, 2024. Certain of these exercises ultimately resulted in their conversion to 2023 Prefunded Warrants. The liability associated with the 2024 Prefunded Warrants, Common Warrants and 2023 Prefunded Warrants is recorded as warrant liability in the accompanying consolidated balance sheet as of December 31, 2024 and December 31, 2023. A summary of the warrant activity for the years ended December 31, 2024 and 2023, respectively is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Warrants ​ 2023 Prefunded Warrants ​ 2024 Prefunded Warrants Outstanding, January 1, 2023 ​ — ​ — ​ — Issued ​ 11,033,804 ​ 503,058 ​ — Outstanding, December 31, 2023 ​ 11,033,804 ​ 503,058 ​ — Issued ​ — ​ — ​ 725,000 Conversions of Common Warrants to 2023 Prefunded Warrants ​ ( 3,896,130 ) ​ 3,896,130 ​ — Exercised ​ ( 7,137,674 ) ​ ( 825,862 ) ​ — Outstanding, December 31, 2024 ​ — ​ 3,573,326 ​ 725,000 ​ The valuation of the warrants is adjusted to fair value (Level 3) at each subsequent balance sheet date until the warrants are settled. The following table provides a rollforward of the aggregate fair value of the warrant liability for the years ended December 31, 2024 and 2023, respectively (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Common Warrants ​ ​ 2023 Prefunded Warrants ​ ​ 2024 Prefunded Warrants ​ ​ Total Offering Warrants Warrant Liability, January 1, 2023 ​ $ — ​ $ — ​ $ — ​ $ — Fair value upon issuance ​ ​ 7,850 ​ ​ 770 ​ ​ — ​ ​ 8,620 Loss on revaluation of warrant liability ​ ​ 3,820 ​ ​ 320 ​ ​ — ​ ​ 4,140 Warrant Liability, December 31, 2023 ​ ​ 11,670 ​ ​ 1,090 ​ ​ — ​ ​ 12,760 Fair value upon issuance ​ ​ — ​ ​ — ​ ​ 2,464 ​ ​ 2,464 Loss on revaluation of warrant liability ​ ​ 13,740 ​ ​ 891 ​ ​ 247 ​ ​ 14,878 Conversions of Common Warrants to 2023 Prefunded Warrants ​ ​ ( 8,898 ) ​ ​ 14,456 ​ ​ — ​ ​ 5,558 Exercised ​ ​ ( 16,512 ) ​ ​ ( 3,072 ) ​ ​ — ​ ​ ( 19,584 ) Warrant Liability, December 31, 2024 ​ $ — ​ $ 13,365 ​ $ 2,711 ​ $ 16,076 ​ F-24 Table of Contents The fair value adjustments were driven mainly by changes in the Company’s stock price and have been recorded as loss on revaluation of warrant liability in the accompanying consolidated statements of operations for the years ended December 31, 2024 and 2023. ​ The Company calculated the fair value of the Common Warrants using the Black-Scholes option pricing model with the following inputs as of June 30, 2024 (the last reporting date prior to all remaining Common Warrant exercises in July 2024) and December 31, 2023: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ June 30, 2024 ​ December 31, 2023 ​ Common stock price ​ $ 4.96 ​ $ 2.16 ​ Expected term (years) ​ ​ 0.1 ​ ​ 0.7 ​ Risk-free interest rate ​ ​ 5.5 % ​ 5.1 % Volatility factor ​ ​ 88.4 % ​ 107.3 % Dividend yield ​ ​ — % ​ — % ​ The Company has used the price of its Class A Common Stock to estimate the fair value of the 2024 Prefunded Warrants and 2023 Prefunded Warrants at each measurement date. The price of the Company’s Class A Common Stock approximates the fair value of the 2024 Prefunded Warrants and 2023 Prefunded Warrants due to the exercise price per share of $ 0.001 . ​ Note 15. Retirement Plan ​ The Company has a defined contribution savings plan under section 401(k) of the Internal Revenue Code. The plan covers substantially all employees. The Company matches employee contributions made to the plan according to a specified formula. The Company’s matching contributions totaled approximately $ 0.1 million and $ 0.3 million for the years ended December 31, 2024 and 2023, respectively. ​ Note 16. Net Loss Per Share ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended (in thousands, except share and per share data) ​ December 31, ​ 2024 2023 Numerator: ​ ​ Net loss from continuing operations ​ $ ( 54,129 ) ​ $ ( 41,249 ) Net income from discontinued operations ​ $ 180 ​ $ 3,593 Net loss ​ $ ( 53,949 ) ​ $ ( 37,656 ) Denominator: ​ ​ Weighted average number of common shares - basic and diluted ​ 29,071,113 ​ 18,160,822 ​ ​ ​ ​ ​ ​ ​ Net loss per share from continuing operations attributable to common stockholders - basic and diluted ​ $ ( 1.86 ) ​ $ ( 2.27 ) Net income per share from discontinued operations attributable to common stockholders - basic and diluted ​ $ 0.01 ​ $ 0.20 Net loss per share - basic and diluted ​ $ ( 1.86 ) ​ $ ( 2.07 ) ​ The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be anti-dilutive. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The Company excluded F-25 Table of Contents the following potential common shares, presented based on amounts outstanding at period end, from the computation of diluted net loss per share attributable to common stockholders: ​ ​ ​ ​ ​ ​ ​ ​ December 31, ​ 2024 2023 Options to purchase common stock 3,220,991 ​ 1,501,193 Restricted stock units ​ 1,417,123 ​ 335,608 Class A common stock warrants ​ 187,969 ​ 187,969 Common Warrants ​ — ​ 11,033,804 2023 Prefunded Warrants ​ 3,573,326 ​ 503,058 2024 Prefunded Warrants ​ 725,000 ​ — Total 9,124,409 ​ 13,561,632 ​ ​ Note 17. Commitment and Contingencies Cook Biotech License and Supply Agreements Elutia has entered into a license agreement, as amended, with Cook Biotech (“Cook”), now owned by Evergen, for an exclusive, worldwide license to the porcine tissue for use in the Company’s Cardiac Patch and CanGaroo products, subject to certain co-exclusive rights retained by Cook (the “Cook License Agreement”). The term of such license is through the date of the last to expire of the licensed Cook patents, which is anticipated to be July 2031. Along with this license agreement, Elutia entered into a supply agreement whereby Cook would be the exclusive supplier to Elutia of licensed porcine tissue. Under certain limited circumstances, Elutia has the right to manufacture the licensed product and pay Cook a royalty of 3 % of sales of the Elutia-manufactured tissue. The supply agreement expires on the same date as the related license agreement. No royalties were paid or due to be paid to Cook during the years ended December 31, 2024 or 2023. The Cook License Agreement also provides for a worldwide exclusive license to the porcine tissue for use with neuromodulation devices in addition to cardiovascular devices and includes license fee payments of $ 0.1 million per year in each of the years 2021 through 2026. Such license payments would accelerate if a change in control, as defined in the Cook License Agreement, occurs within Elutia. The Company, in its sole discretion, can terminate the Cook License Agreement at any time. Legal Proceedings From time to time, the Company may be involved in claims and proceedings arising in the course of the Company’s business. The outcome of any such claims or proceedings, regardless of the merits, is inherently uncertain. The Company records accruals for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated. Where the available information is only sufficient to establish a range of probable liability, and no point within the range is more likely than any other, the lower end of the range has been used. When a material loss contingency is reasonably possible, but not probable, the Company does not record a liability, but instead discloses the nature of the matter and an estimate of the loss or range of loss, to the extent such estimate can be made. Accruals recorded are adjusted periodically as assessments change or additional information becomes available, and management's judgments may be materially different than the actual outcomes. FiberCel Litigation In June 2021, the Company announced a voluntary recall of a single lot of FiberCel fiber viable bone matrix. Since September 2021, 110 product liability lawsuits or claims have been filed or asserted against the Company involving FiberCel. As of December 31, 2024, there were 66 active lawsuits or claims against the Company, including 23 lawsuits or claims where settlements have been reached but not yet been paid as of December 31, 2024. The lawsuits, which have been filed against Elutia, certain Medtronic entities, and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of FiberCel during orthopedic fusion operations. Such lawsuits were filed in the Superior Court of Marion County, Indiana (collectively, the “Indiana State Complaints”); the Superior Court of the State of Delaware (collectively, the “Delaware State Complaints”); the Circuit Court of Maryland (collectively, the “Maryland State Complaints”); the Court of Common Pleas of F-26 Table of Contents Montgomery County, Ohio and the U.S. District Court of the Southern District of Ohio (the “Ohio Complaints”); the U.S. District Court for the Western District and Eastern District of North Carolina (collectively, the “North Carolina Federal Complaints”); the Circuit Court of Okaloosa County, Florida, and the U.S. District Court for the Northern District and the Southern District of Florida (collectively, the “Florida Complaints”); the U.S. District Courts for the Eastern District of Michigan (collectively “Michigan Federal Complaints.”); the U.S. District Court for the District of Colorado (“Colorado Federal Complaint”); the U.S. District Court for the District of Oregon (“Oregon Federal Complaint”); the Circuit Court of Fayette County, Kentucky and the U.S. District Court for the Eastern District of Kentucky (collectively, “Kentucky Complaints.”); the U.S. District Court for the Western District of Louisiana (“Louisiana Federal Complaint”);the Circuit Court of Cook County, Illinois and the U.S. District Court for the Northern District of Illinois (collectively, the “Illinois Complaints”); the U.S. District Court for the Eastern District of Pennsylvania (“Pennsylvania Federal Complaint); the U.S. District Court for the Eastern District of Virginia (“Virginia Federal Complaint”); the U.S. District Court for the Central District of California (“California Federal Complaint”); the U.S. District Court of Arizona (“Arizona Federal Complaint"); and the U.S. District Court for the Northern District of Georgia (“Georgia Federal Complaint”). ​ Plaintiffs in the Indiana State Complaints allege a cause of action under Indiana’s Product Liability Act, citing manufacturing defects, defective design and failure to properly warn and instruct, and several of the complaints allege loss of consortium. Plaintiffs in these actions assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing and labeling FiberCel and seek various types of damages, including economic damages, non-economic damages and loss of consortium. Plaintiffs in one of the Indiana State Complaints allege causes of action for product liability, negligence, breach of express and implied warranties, and punitive damages. Each of the plaintiffs in the Delaware State Complaints alleges negligence, breach of implied warranty, breach of express warranty, medical monitoring, and punitive damages, and two also allege loss of consortium. Plaintiffs in the Delaware State Complaints seek economic, consequential, and punitive damages. The Maryland State Complaints assert claims of negligence, breach of implied warranty, breach of express warranty, medical monitoring, and loss of consortium. The Florida Complaints contain three strict liability claims for defective design, defective manufacture, and failure to warn. A claim for punitive damages is also pled. The Ohio State Complaint alleges causes of action for product liability and negligence and seeks compensatory damages. The Colorado Federal Complaint asserts causes of action for strict product liability, misrepresentation, negligence, breach of express warranty, and breach of implied warranty of merchantability. The Michigan Federal Complaints assert causes of action for negligence, gross negligence breach of implied warranty, breach of express warranty, intentional infliction of emotional distress, and liability under the res ipsa loquitur doctrine. The Michigan Federal Complaints seek compensatory damages and punitive damages. The North Carolina Federal Complaints allege causes of action for negligence, defective design, breach of implied warranty, breach of express warranty, and loss of consortium, and seek both compensatory and punitive damages. The Oregon Federal Complaint asserts strict liability claims for defective design, defective manufacture, and failure to warn, and seeks compensatory damages. The Ohio Federal Complaint asserts strict liability claims for defective manufacturing, inadequate warning, nonconformance with representations, and also alleges loss of consortium and seeks compensatory damages. The Kentucky Complaints assert strict liability claims based on manufacturing defect, design defect, failure to warn, negligence, breach of implied warranty, breach of express warranty, and seek recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages. The Louisiana Federal Complaint asserts claims of violation of the Louisiana Products Liability Act, negligence and gross negligence, breach of implied warranty, and breach of express warranty and seeks recovery for medical monitoring. The Illinois Complaints contain claims of strict liability, defective design and manufacturing, breach of express warranty, breach of implied warranty and negligence and seek compensatory damages. The Pennsylvania Federal Complaint asserts claims for strict liability, negligence, breach of implied warranty, and breach of express warranty, as well as claims under the Wrongful Death Act and the Survival Act, and seeks compensatory and punitive damages. The Virginia Federal Complaint asserts causes of action for negligent failure to warn, negligence, breach of implied warranty, and breach of express warranty and seeks recovery for medical monitoring, compensatory damages and punitive damages. The California Federal Complaint advances claims of strict liability (defective design and manufacture), negligence and breach of implied warranty and seeks compensatory damages and recovery for medical monitoring. The Arizona Federal Complaint asserts strict product liability claims for defective design, manufacture and failure to warn, negligence, breach of implied warranty and breach of express warranty and seeks recovery for medical monitoring, loss of consortium, compensatory damages, and punitive damages. The Georgia Federal Complaint asserts causes of action for negligence, including negligent design, negligent failure to warn, negligent manufacturing, and negligent misrepresentation; strict liability claims based on manufacturing defect, design defect, and F-27 Table of Contents failure to warn; breach of implied warranty of merchantability; breach of implied warranty of fitness for a particular purpose; breach of express warranty; and loss of consortium and it seeks compensatory damages and punitive damages. ​ The Company refers to the aforementioned litigation and claim notices collectively as the “FiberCel Litigation.” ​ Viable Bone Matrix Litigation ​ In July 2023, the Company announced a voluntary recall of a single lot of a certain viable bone matrix (“VBM”) product and the market withdrawal of all of its VBM products produced after a specified date. Notice of the voluntary recall was issued to centers after the Company learned of post-surgical Mycobacterium tuberculosis (“MTB”) infections in two patients treated with a VBM product from a single donor lot. Prior to release, samples from this specific lot had tested negative for MTB by an independent laboratory using a nucleic acid test that is designed to specifically detect the MTB organism. Based on our discussions with the CDC, the Company believes that a total of 36 patients were treated with product from the single donor lot. Since August 2023, 24 product liability lawsuits or claims have been filed or asserted against the Company involving VBM. As of December 31, 2024, there were 15 active lawsuits or claims against the Company, including three lawsuits or claims where settlements had been reached but not yet paid. Furthermore, there is one claim where the statute of limitation to file a lawsuit has expired. The lawsuits, which have been filed against Elutia and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of VBM during orthopedic fusion operations. To date, these lawsuits have been filed in California Superior Court (collectively, the “California State Complaints”), the United States District Court for the Southern District of California (the “California Federal Complaint”), the United States District Court for the Eastern District of Louisiana (collectively, the “Louisiana Federal Complaints”), and the United States District Court for the Western District of Texas (the “Texas Federal Complaint”). ​ Plaintiffs in the California State Complaints and California Federal Complaint assert that the defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing, and labeling VBM and seek various types of damages, including economic damages, non-economic damages, and loss of consortium damages. The Plaintiffs in one of the California State Complaints also assert claims for fraudulent inducement, misrepresentation, and intentional infliction of emotional distress. Plaintiffs in the Louisiana Federal Complaints generally assert causes of action under the Louisiana Product Liability Act, citing design defects, manufacturing defects, and failure to properly warn, and several plaintiffs allege loss of consortium. Plaintiffs in these actions also assert that defendants are strictly liable or have breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing and labeling VBM and seek economic damages, non-economic damages and loss of consortium. Some plaintiffs in the Louisiana Federal Complaints also allege claims for breach of implied warranty and breach of express warranty, medical monitoring, and punitive damages. Plaintiffs in the Texas Federal Complaint assert violations of the Texas Business and Commerce Code, citing alleged breaches of the warranties of merchantability and fitness for a particular purpose. Plaintiffs further assert that the defendants breached the duty of care owed to plaintiffs by failing to exercise reasonable care in designing, manufacturing, marketing, and labeling VBM and seek various types of damages, including economic damages, non-economic damages, exemplary damages, and loss of consortium damages. ​ The Company refers to the aforementioned litigation and claim notices collectively as the “VBM Litigation.” ​ Medtronic Litigation ​ In June 2024, the Company filed an action against Medtronic Sofamor Danek USA, Inc. (“Medtronic”) in the Superior Court of the State of Delaware. The Company’s complaint alleges breach of the 2019 Tissue Product Supply Agreement (the “Supply Agreement”) between the Company and Medtronic. In particular, the complaint alleges that Medtronic did not honor its contractual obligations to obtain insurance coverage and to defend and indemnify the Company for over 100 lawsuits against the Company alleging claims arising from the use of FiberCel products distributed by Medtronic. The complaint does not specify the amount of damages owed by Medtronic for these breaches. On July 31, 2024, Medtronic responded to the complaint by denying Elutia’s claims and asserting a single counterclaim alleging that Elutia breached certain representations and warranties under the Supply Agreement and owes ongoing indemnity obligations to Medtronic. The counterclaim does not specify the amount of any alleged damages. On October 15, 2024, F-28 Table of Contents Medtronic filed a motion to dismiss Elutia’s claims. The court held a hearing on January 9, 2025, and has not yet issued a ruling on the motion to dismiss. Given the early stages of this matter and the Company’s intention to vigorously defend this counterclaim, we do not consider a loss to be probable or estimable at this time. ​ Contingent Liability for Legal Proceedings ​ FiberCel Litigation ​ Since August 2022, the Company has engaged in a process to negotiate and attempt to resolve many of the cases in the FiberCel Litigation. In total, Elutia’s liability in 44 of the cases was settled for a total cash outlay of approximately $ 14.4 million. For the remaining 66 cases, the Company estimated a probable loss related to each case and has recorded a liability at a total estimated amount of $ 15.9 million at December 31, 2024, which is recorded as Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. Such liability includes $ 8.2 million for which the settlements have been reached but have not yet been paid. ​ In order to reasonably estimate the liability for the unsettled FiberCel Litigation cases, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the FiberCel Litigation. While the Company believes its estimated liability to be reasonable, the actual loss amounts are highly variable and are dependent upon the relevant facts and case by case resolutions. As more information is learned about asserted claims and potential future trends, adjustments may be made to this Contingent Liability for Legal Proceedings as appropriate. Management believes that it is reasonably possible that the Company could incur liabilities in excess of amounts accrued and the ultimate liability could be material to the Company’s financial position, results of operations and cash flows in the period recognized. The Company, however, is unable to estimate the possible loss or range of loss in excess of the amount recognized at this time. ​ VBM Litigation ​ Since June 2023, the Company has also engaged in a process to negotiate and attempt to resolve many of the cases in the VBM Litigation. In total, Elutia’s liability in nine of the cases has been settled for a total cash outlay of approximately $ 1.0 million. For the remaining 26 cases, which includes unasserted claims that the Company believes are probable of assertion, the Company estimated a probable loss at an estimated amount of $ 4.5 million at December 31, 2024, which is recorded as Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. Such liability includes $ 0.5 million for which the settlements have been reached but have not yet been paid. The expense related to this estimate was recorded within Litigation costs, net in the accompanying consolidated statement of operations, with the entirety of such expense offset by insurance recoveries received or receivable as further described below. ​ In order to reasonably estimate the liability for the unsettled VBM Litigation cases and unasserted claims, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the VBM Litigation. While the Company believes its estimated liability to be reasonable, the actual loss amounts are highly variable and are dependent upon the relevant facts and case-by-case resolutions. As more information is learned about asserted and unasserted claims and potential future trends, adjustments may be made to this Contingent Liability for Legal Proceedings as appropriate. Management believes that it is reasonably possible that the Company could incur liabilities in excess of amounts accrued and the ultimate liability could be material to the Company’s financial position, results of operations and cash flows in the period recognized. The Company, however, is unable to estimate the possible loss or range of loss in excess of the amount recognized at this time. ​ Defense costs for both the FiberCel Litigation and VBM Litigation are recognized in the accompanying consolidated statements of operations as incurred, with the entirety of such expense related to the VBM Litigation offset by insurance recoveries received or receivable as further described below. ​ F-29 Table of Contents Insurance Receivables of Litigation Costs ​ The Company has purchased insurance coverage that, subject to common contract exclusions, provided coverage for the FiberCel Litigation and VBM Litigation product liability losses as well as legal defense costs. When settlements are reached and/or amounts are recorded in the related Contingent Liability for FiberCel Litigation, the Company calculates amounts due to be reimbursed pursuant to the terms of the coverage and related agreements, and pursuant to other indemnity or contribution claims, in respect of product liability losses and related defense costs. The amounts probable of reimbursement or recovery from this calculation are recorded as receivables. The determination that the recorded receivables are probable of collection is based on the terms of agreements reached in respect of indemnity and contribution claims as well as the advice of the Company’s outside legal counsel. These receivables as of December 31, 2024 and 2023 totaled $ 4.8 million and $ 2.7 million, respectively and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets. All such receivables as of December 31, 2024 related to the VBM Litigation, and nearly all of such receivables at December 31, 2023 related to the FiberCel Litigation. ​ The Company had been pursuing additional recovery amounts in respect of indemnity and contribution claims with certain insurance providers. During the year ended December 31, 2024, the Company resolved these matters through a settlement totaling $ 1.6 million, with such recovery being recorded within Litigation costs, net in the accompanying consolidated statement of operations for the year ended December 31, 2024. ​ As of both December 31, 2024 and 2023, the Company was not a party to, or aware of, any legal matters or claims with material financial exposure, except for the FiberCel Litigation, VBM Litigation and Medtronic matter. ​ Note 18. Segment Information With the divestiture of the Orthobiologics Business, the Company now operates in three segments. The Company determined its operating and reportable segments to be consistent with its major product groupings – Device Protection, Women’s Health and Cardiovascular. The accounting policies of the segments are the same as those described in the summary of significant accounting policies. The Chief Operating Decision Maker ("CODM") is the Chief Executive Officer. The CODM evaluates the performance of our segments based upon, among other things, segment net sales and segment gross profit, excluding intangible asset amortization (“segment gross profit”). Segment gross profit is what the CODM uses in evaluating our results of operations and the financial measure that provides insight into our overall performance and financial position. The CODM considers budget-to-actual variances and variances against prior years using segment gross profit when making decisions about allocating resources to the segments. Asset information is not provided as the Company's CODM does not regularly review or utilize detailed asset data to assess segment performance. ​ For the year ended December 31, 2024, the Company’s segment gross profit was comprised of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Device Protection ​ ​ Women's Health ​ ​ Cardiovascular ​ ​ Total Net sales $ 9,907 ​ $ 11,553 ​ $ 2,915 ​ $ 24,375 Cost of goods sold, excluding intangible asset amortization ​ 3,594 ​ ​ 5,568 ​ ​ 1,108 ​ ​ ​ Segment gross profit $ 6,313 ​ $ 5,985 ​ $ 1,807 ​ $ 14,105 ​ The net sales for the year ended December 31, 2024 include the revenues derived from one customer which represents 14 % of total net sales. Such customer is included within the Cardiovascular segment. ​ F-30 Table of Contents For the year ended December 31, 2023, the Company’s segment gross profit was comprised of the following (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Device Protection ​ ​ Women's Health ​ ​ Cardiovascular ​ ​ Total Net sales $ 9,401 ​ $ 10,304 ​ $ 5,040 ​ $ 24,745 Cost of goods sold, excluding intangible asset amortization ​ 2,836 ​ ​ 5,902 ​ ​ 1,556 ​ ​ ​ Segment gross profit $ 6,565 ​ $ 4,402 ​ $ 3,484 ​ $ 14,451 ​ The net sales for the year ended December 31, 2023 include the revenues derived from one customer which represents 10 % of total net sales. Such customer is included within the Cardiovascular segment. ​ The following table is a reconciliation of segment gross profit to the consolidated loss before provision for income taxes for the years ended December 31, 2024 and 2023 (in thousands): ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended ​ ​ December 31, ​ 2024 2023 ​ ​ ​ ​ ​ ​ ​ Segment gross profit ​ $ 14,105 ​ $ 14,451 Adjustments: ​ ​ ​ ​ ​ ​ Intangible asset amortization expense ​ ​ 3,398 ​ ​ 3,398 Sales and marketing ​ ​ 12,546 ​ ​ 13,087 General and administrative ​ ​ 18,659 ​ ​ 14,104 Research and development ​ ​ 3,785 ​ ​ 4,399 Litigation costs, net ​ ​ 11,368 ​ ​ 9,989 Loss from operations ​ ​ ( 35,651 ) ​ ​ ( 30,526 ) Interest expense ​ ​ 4,779 ​ ​ 5,796 Loss on revaluation of warrant liability ​ ​ 14,878 ​ ​ 4,140 Other (income) expense, net ​ ​ ( 1,186 ) ​ ​ 759 Loss before provision for income taxes ​ $ ( 54,122 ) ​ $ ( 41,221 ) ​ During the years ended December 31, 2024 and 2023, the Company did not have any material international product sales, and the Company did not own any long-lived assets outside the United States. ​ ​ ​ F-31