Item 9A. Controls and Procedures
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, 2025.
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, 2025, our internal control over financial reporting was effective.
Attestation Report of the Registered Public Accounting Firm
As a “smaller reporting company”, our independent registered accounting firm is not required to issue an attestation report on our internal control over financial reporting.
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Table of Contents
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, 2025 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, 2025, 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.
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 2026 (the “2026 Annual Meeting of Stockholders”), which we intend to file with the SEC within 120 days of the year ended December 31, 2025.
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 2026 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2025.
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, 2025.
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)
2,148
$
6.37
(4)
—
2020 Plan (2)
4,022,598
$
4.75
(4)
1,597,158
ESPP (3)
—
—
763,965
Equity Compensation Plans Not Approved by Stockholders
—
—
—
Total
4,024,746
$
—
2,361,123
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Table of Contents
(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.
(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 2026 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2025.
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 relating to the 2026 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2025.
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 2026 Annual Meeting of Stockholders, which we intend to file with the SEC within 120 days of the year ended December 31, 2025.
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.
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Table of Contents
(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
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
78
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
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
4.9
2025 Form of Prefunded Warrant
8-K
001-39577
4.1
2/4/2025
4.10
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
10-K
001-39577
10.6
3/23/2023
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Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
and form of stock option agreements thereunder
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
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 December 31, 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
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Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
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 Agent and the Lenders from time to time party thereto
8-K
001-39577
10.1
8/15/2022
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
81
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
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
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
8-K
001-39577
10.1
1/12/2024
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Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
Ligand Pharmaceuticals Incorporated
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
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
10.35
2025 Form of Placement Agency Agreement
8-K
001-39577
10.1
2/4/2025
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Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
dated February 3, 2025 between Lake Street Capital Markets, LLC and Elutia In.
10.36
2025 Form of Securities Purchase Agreement dated February 3, 2025 between Elutia Inc. and the purchasers named therein
8-K
001-39577
10.2
2/4/2025
10.37
Subscription Agreement and Amendment No. 2 to Royalty Agreement dated May 8, 2025 between Elutia Inc., Elutia Med LLC and Ligand Pharmaceuticals Incorporation
10-Q
001-39577
10.37
5/13/2025
10.38
Fourth Amendment to Credit Agreement dated May 7, 2025 by and among Elutia Inc., SWK Funding LLC as Agent and the lenders from time to time party thereto
10-Q
001-39577
10.38
5/13/2025
10.39
Fifth Amendment to Credit Agreement, dated as of August 14, 2025, 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
8/20/2025
10.40+#
Asset Purchase Agreement, dated September 8, 2025, by and among Boston Scientific Corporation and Cardiac Pacemakers Inc. and Elutia Inc. and Elutia Med LLC
8-K
001-39577
10.1
9/9/2025
10.41#
Consent, Release and Amendment No. 3 dated as of October 1, 2025 to Royalty Agreement by and between Elutia Med
8-K
001-39577
10.2
10/7/2025
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Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
LLC and Ligand Pharmaceuticals Incorporated.
10.42†
Consulting Agreement, dated December 1, 2023, between Elutia Inc. and Guido Neels
10-Q
001-39577
10.42
11/12/2025
19
Insider Trading Compliance Policy
10-K
001-39577
19
3/11/2025
21.1
Subsidiaries of Elutia, Inc.
*
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.
*
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
**
85
Table of Contents
Exhibit Number
Description
Form
File No.
Exhibit
Filing Date
Filed/Furnished Herewith
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
*
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.
+ Certain confidential information contained in this exhibit, marked in brackets, has been omitted, because it is both not material and of the type of information that the registrant treats as private or confidential.
86
Table of Contents
# 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.
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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 13, 2026
By:
/s/ C. RANDAL MILLS, PH.D.
C. Randal Mills, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
Date: March 13, 2026
/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 13, 2026
C. Randal Mills, Ph.D.
/s/Matthew Ferguson
Chief Financial Officer
(principal financial officer and principal accounting officer)
March 13, 2026
Matthew Ferguson
/s/Kevin Rakin
Chairperson of the Board of Directors
March 13, 2026
Kevin Rakin
/s/Guido Neels
Director
March 13, 2026
Guido Neels
/s/David Colpman
Director
March 13, 2026
David Colpman
/s/Brigid A. Makes
Director
March 13, 2026
Brigid A. Makes
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ELUTIA INC.
INDEX TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID: 238 )
F-2
Consolidated Balance Sheets
F-4
Consolidated Statements of Operations
F-5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
F-6
Consolidated Statements of Cash Flows
F-7
Notes to Consolidated Financial Statements
F-8
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 subsidiary (the "Company") as of December 31, 2025 and 2024, 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, 2025 and 2024, 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.
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.
Emphasis of Matter
As discussed in Note 2 to the consolidated financial statements, the Company has negative cash flows from operations and an accumulated deficit as of December 31, 2025. Management’s evaluation of the events and conditions related to this matter are also described in Note 2.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Litigation Contingencies - FiberCel and Viable Bone Matrix Products
As described in Note 17 to the consolidated financial statements, the Company’s contingent liability for legal proceedings related to FiberCel and viable bone matrix (VBM) products was $11.2 million as of December 31, 2025. Management 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
F-2
Table of Contents
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. In June 2021, the Company announced a voluntary recall of a single lot of FiberCel fiber viable bone matrix. In July 2023, the Company announced a voluntary recall of a single lot of a certain VBM product and the market withdrawal of all of its VBM products produced after a specified date.
The principal considerations for our determination that performing procedures relating to the litigation contingencies for FiberCel and VBM products is a critical audit matter are (i) the significant judgment by management when assessing whether a loss is reasonably possible or probable and if probable, whether the amount of the loss or range of loss can be reasonably estimated and (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence related to management’s assessment of the litigation contingencies.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others (i) confirming with external legal counsel the possibility or probability of an unfavorable outcome and the extent to which the loss or range of loss is reasonably estimable; (ii) obtaining and evaluating certain settlement agreements; (iii) testing a sample of legal settlements paid; (iv) evaluating the reasonableness of management’s assessment regarding whether an unfavorable outcome is reasonably possible or probable and reasonably estimable; and (v) evaluating the sufficiency of the Company’s litigation contingency disclosures related to the FiberCel and VBM matters.
/s/ PricewaterhouseCoopers LLP
Philadelphia, Pennsylvania
March 13, 2026
We have served as the Company’s auditor since 2015.
F-3
Table of Contents
ELUTIA INC.
CONSOLIDATED BALANCE SHEETS
(In Thousands, Except for Share and Per Share Data)
December 31,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
36,350
$
13,239
Accounts receivable, net
1,734
2,276
Inventory
2,617
1,931
Insurance receivables of litigation costs
4,846
4,760
Prepaid expenses and other current assets
2,271
1,986
Divestiture proceeds receivable
8,000
—
Current assets of discontinued operations
—
1,980
Total current assets
55,818
26,172
Property and equipment, net
2,511
671
Intangible assets, net
1,529
2,600
Operating lease right-of-use assets and other
2,492
179
Noncurrent assets of discontinued operations
—
6,505
Total assets
$
62,350
$
36,127
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
4,791
$
4,149
Accrued expenses
4,352
7,104
Current portion of long-term debt
—
1,250
Current portion of revenue interest obligation
4,400
4,400
Contingent liability for legal proceedings
11,241
20,432
Current operating lease liabilities
355
145
Current liabilities of discontinued operations
—
315
Total current liabilities
25,139
37,795
Long-term debt
—
22,603
Long-term revenue interest obligation
2,828
5,490
Warrant liability
3,124
16,076
Long-term operating lease liabilities
3,587
16
Noncurrent liabilities of discontinued operations
—
407
Total liabilities
34,678
82,387
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, 2025 and December 31, 2024, and 42,784,848 and 30,897,232 shares issued and outstanding , as of December 31, 2025 and December 31, 2024, respectively
43
31
Class B Common stock, $ 0.001 par value, 20,000,000 shares authorized as of December 31, 2025 and December 31, 2024, and 0 and 4,313,406 shares issued and outstanding , as of December 31, 2025 and December 31, 2024, respectively
—
4
Additional paid-in capital
203,842
183,298
Accumulated deficit
( 176,213 )
( 229,593 )
Total stockholders’ equity (deficit)
27,672
( 46,260 )
Total liabilities and stockholders' equity (deficit)
$
62,350
$
36,127
The accompanying notes are an integral part of these consolidated financial statements.
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ELUTIA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Data)
Year Ended
December 31,
2025
2024
Net sales
$
12,293
$
14,467
Cost of goods sold
5,697
7,752
Gross profit
6,596
6,715
Sales and marketing
5,765
4,988
General and administrative
15,080
18,073
Research and development
4,163
2,998
Litigation costs, net
8,499
11,368
Total operating expenses
33,507
37,427
Loss from continuing operations
( 26,911 )
( 30,712 )
Interest (income) expense, net
( 387 )
934
(Gain) loss on revaluation of warrant liability
( 13,424 )
14,878
Other expense (income), net
2,758
( 1,186 )
Loss from continuing operations before provision for income taxes
( 15,858 )
( 45,338 )
Income tax expense
13
7
Net loss from continuing operations
( 15,871 )
( 45,345 )
Income (loss) from discontinued operations
69,251
( 8,604 )
Net income (loss)
53,380
( 53,949 )
Less: dilutive gain on revaluation of warrant liability
( 13,424 )
—
Net income (loss) for dilutive earnings per share
$
39,956
$
( 53,949 )
Net loss from continuing operations per share - basic
$
( 0.38 )
$
( 1.56 )
Net loss from continuing operations per share - diluted
$
( 0.64 )
$
( 1.56 )
Net income (loss) from discontinued operations per share - basic
$
1.67
$
( 0.30 )
Net income (loss) from discontinued operations per share - diluted
$
1.51
$
( 0.30 )
Net income (loss) per share - basic
$
1.29
$
( 1.86 )
Net income (loss) per share - diluted
$
0.87
$
( 1.86 )
Weighted average common shares outstanding - basic
41,416,850
29,071,113
Weighted average common shares outstanding - diluted
45,942,787
29,071,113
The accompanying notes are an integral part of these consolidated financial statements.
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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, 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 )
Issuance of common stock in connection with registered direct offering, net of issuance costs of $ 1.1 million
5,520,000
6
—
—
12,590
—
12,596
Exercise of Common Warrants and Prefunded Warrants
249,910
—
—
—
727
—
727
Issuance of common stock under Employee Stock Purchase Plan
59,268
—
—
—
112
—
112
Issuance of stock for interest payment
1,155,528
1
—
—
2,281
—
2,282
Vesting of restricted stock units, net of shares withheld and taxes paid
589,504
1
—
—
( 380 )
—
( 379 )
Stock-based compensation
—
—
—
—
5,214
—
5,214
Conversion of Class B Common Stock to Class A Common Stock
4,313,406
4
( 4,313,406 )
( 4 )
—
—
—
Net income
—
—
—
—
—
53,380
53,380
Balance, December 31, 2025
42,784,848
$
43
—
$
—
$
203,842
$
( 176,213 )
$
27,672
The accompanying notes are an integral part of these consolidated financial statements.
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ELUTIA INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
Year Ended
December 31,
2025
2024
Net income (loss)
$
53,380
$
( 53,949 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization
2,785
3,451
Gain on sale of Orthobiologics Business, excluding divestiture costs
—
( 180 )
Gain on sale of CIED Business, excluding divestiture costs
( 80,211 )
—
Loss on early repayment of debt
1,287
—
(Gain) loss on revaluation of warrant liability
( 13,424 )
14,878
Gain on revaluation of revenue interest obligation
—
( 1,443 )
Interest expense recorded as additional revenue interest obligation and long-term debt
3,827
3,076
Stock-based compensation
5,214
7,891
Bad debt expense
458
460
Payments on revenue interest obligation
( 2,200 )
—
Other
608
216
Changes in operating assets and liabilities, net:
Accounts receivable
84
527
Inventory
( 1,641 )
( 58 )
Insurance receivables of litigation costs
( 86 )
( 2,064 )
Prepaid expenses and other
( 285 )
743
Accounts payable and accrued expenses
( 6,547 )
( 1,148 )
Contingent liability for legal proceedings
( 9,191 )
5,408
Other liabilities
1,132
( 465 )
Net cash used in operating activities
( 44,810 )
( 22,657 )
INVESTING ACTIVITIES:
Proceeds from sale of Orthobiologics Business
—
180
Proceeds from sale of CIED Business
80,435
—
Expenditures for property and equipment, net
( 1,876 )
( 654 )
Net cash provided by (used in) investing activities
78,559
( 474 )
FINANCING ACTIVITIES:
Proceeds from public offering with warrants, net of offering costs
13,795
12,390
Repayments of long-term debt
( 23,064 )
( 2,000 )
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
Repayments of insurance premium financings
( 1,101 )
( 1,995 )
Payments for taxes upon vesting of restricted stock units
( 380 )
( 1,188 )
Proceeds from stock option exercises and issuance of common stock under ESPP
112
162
Net cash (used in) provided by financing activities
( 10,638 )
17,094
Net increase (decrease) in cash and cash equivalents
23,111
( 6,037 )
Cash and cash equivalents, beginning of year
13,239
19,276
Cash and cash equivalents, end of year
$
36,350
$
13,239
Supplemental Cash Flow and Non-Cash Investing and Financing Activities Disclosures:
Cash paid for interest
$
7,492
$
5,288
Deferred proceeds from sale of CIED Business recognized as receivable
$
8,000
$
—
Issuance of common stock as payment under revenue interest obligation and long-term debt
$
2,281
$
—
Additions to operating lease right-of-use assets in exchange for lease liabilities, net of early terminations
$
2,271
$
1,141
Conversion of Common Warrants and Prefunded Warrants to common stock
$
727
$
19,584
The accompanying notes are an integral part of these consolidated financial statements.
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ELUTIA INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. Organization and Description of Business
Elutia Inc. (together with its consolidated subsidiary, "Elutia” or the “Company”) is a commercial-stage company developing proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications. These products are designed to improve the interaction between implanted medical devices and patients. The Company’s focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis. Elutia’s portfolio of products spans the Women’s Health and Cardiovascular markets. These products are sold to healthcare providers.
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 September 8, 2025, Elutia executed an Asset Purchase Agreement (the “APA”) with Boston Scientific Corporation (“BSC”), a Delaware corporation, and Cardiac Pacemakers Inc. (“CPI”), a Minnesota corporation (collectively with BSC, the “ CIED Buyers”). On October 1, 2025, at the closing of the transactions contemplated by the APA, the CIED Buyers purchased from the Company substantially all of the assets that are related to the Company’s business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing its cardiac implantable electronic device (“CIED”) products, including its CanGaroo®, CanGaroo® RM, EluPro™ and CIED envelope products, including next generation CIED envelope products (collectively the “CIED Business”). The assets of the CIED Business constitute substantially all of the assets previously held in Elutia’s Device Protection segment. The CIED Buyers only assumed certain liabilities related to performance of the contracts transferred in the APA. The APA provides for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the APA, of up to $ 88.0 million in cash, with $ 80.4 million (which includes an inventory adjustment of $ 0.4 million) that was paid in cash to Elutia at the closing of the transactions or shortly thereafter, and $ 8.0 million that was deposited at the closing of the transactions in escrow with a bank for twelve months , which is subject to potential reduction in the event of certain post-closing breaches of representations and warranties within the APA by the Company. The Company recognized a gain , net of tax effect and divestiture costs, of $ 76.1 million on the sale of the CIED Business during the year ended December 31, 2025. Such gain includes the recognition of the $ 8.0 million in escrow as a divestiture proceeds receivable on the accompanying balance sheet as of December 31, 2025.
The sale of the CIED Business represents a strategic shift that has a major effect on the Company’s operations and financial results. Consequently, the Company met the held-for-sale criteria of Accounting Standards Codification (“ASC”) 205-20, Discontinued Operations . Accordingly, this transaction is accounted for as Discontinued Operations for all periods presented in accordance with ASC 205-20, Discontinued Operations . Unless indicated otherwise, the information in the notes to the consolidated financial statements relates to continuing operations. See Note 4 for further discussion of the divestiture of the CIED Business.
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 approximately
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$ 14.6 million, and the Company may earn up to an additional $ 20 .0 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 were no earn-out payments earned or paid in the years ended December 31, 2025 or 2024. 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 in the fourth quarter of 2023 and an additional gain of $ 0.2 million in the second quarter of 2024 from an adjustment payment related to the final working capital received by Berkeley at the sale date. Additionally, the purchase agreement provided for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after closing of the transaction. The indemnity holdback was available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback could be retained by Berkeley if Berkeley was successful in asserting a claim or claims for indemnification against the Company. In March 2026, the indemnity holdback was resolved with Berkeley remitting $ 0.4 million to Elutia. Such amount will be recognized as additional gain in the first quarter of 2026. Should the Company receive incremental proceeds in the future through an earn-out payment, an additional gain will be recorded upon the receipt of such amounts.
Since inception, the Company has financed its operations primarily through amounts borrowed under its credit facilities, proceeds from its initial public offering (“IPO”), sales of its products and more recently, the sale of its Orthobiologics and CIED Businesses and proceeds from follow-on offerings and private placements of its common stock and warrants to purchase its common stock. The Company’s historical cash outflows have primarily been associated with manufacturing and administrative costs, sales and marketing, research and development, clinical activity, purchase of property and equipment used in its production activities, litigation defense and settlement costs and investing in its commercial infrastructure. For the year ended December 31, 2025, the Company incurred a loss from continuing operations of $ 15.9 million, and as of December 31, 2025, the Company had an accumulated deficit of $ 176.2 million. In addition, during the year ended December 31, 2025, the Company used $ 44.8 million of cash in operating activities. The Company expects to incur operating losses and negative cash flows from operations for the foreseeable future, as the Company advances its development and commercialization of NXT-41 and NXT-41x. Because of the numerous risks and uncertainties associated with the Company’s development and commercialization efforts, the Company is unable to predict when it will become profitable, and it may never become profitable. The future viability of the Company is dependent on its ability to generate cash flows from current or future product sales and/or raise additional capital to finance its operations. The Company may seek to raise capital through the issuance of common stock or debt such as the offerings described in Note 14 or pursue asset sales or other transactions, such as the sale of the CIED and Orthobiologics Businesses described above. However, such transactions may not be successful, and we may not be able to raise additional equity, refinance our debt instruments, sell assets or obtain waivers or amendments to our obligations on acceptable terms, or at all.
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. The Company believes that its existing cash and cash equivalents as of December 31, 2025, which include the proceeds from the sale of the CIED Business, will be sufficient to fund its operating expenses and capital expenditure requirements through at least one year after the issuance date of the consolidated financial statements. If the Company is unable to obtain sufficient funding when needed and/or on acceptable terms, the Company may be required to significantly curtail, delay or discontinue its research and development programs, the manufacture of clinical and commercial supplies, product portfolio expansion, commercialization efforts and/or commercial operations, which could adversely affect its business prospects, or the Company may be unable to continue operations.
Reclassifications
T he Company has determined that its operating and reportable segments are consistent with its major product groupings which in prior periods included Device Protection, Women’s Health and Cardiovascular. Segment results for the year ended December 31, 2024, have been recast to conform to the new segment presentation, which now excludes Device Protection due to its divestiture noted above. Refer to the Segment Information in Note 18.
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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 Income (Loss) per Share
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, 2025 and 2024. During the year ended December 31, 2025, all outstanding shares of Class B common stock were converted to Class A common stock. Consequently, as of December 31, 2025, there are no shares of Class B common stock outstanding.
Basic net income (loss) per share is computed by dividing net loss 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. For purposes of the diluted net income (loss) per share calculation, stock options, restricted stock units (“RSUs”) and warrants are considered to be common stock equivalents. In applying the two-class method, the Company has elected an accounting policy to determine whether undistributed earnings are allocated to participating securities by analogy to the ‘control number’ concept in ASC 260. Accordingly, the Company evaluates income (loss) from continuing operations to determine whether participating securities are allocated earnings. Participating securities are not allocated losses as they are not contractually obligated to share in losses. This policy is applied consistently from period to period. See Note 16 for further discussion of net income (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.
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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 $ 0.5 million and $ 0.6 million as of December 31, 2025 and 2024, respectively.
Inventory
Inventory, consisting of primarily purchased materials, 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 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
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lease. For leases with a term of 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 that 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 in the years ended December 31, 2025 and 2024.
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 and February 2025 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 settlement date and at each balance sheet date and any change in fair value is recognized in (Gain) loss on revaluation of warrant liability in the accompanying consolidated statements of operations.
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. 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
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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, 2025 and 2024.
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.
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, 2025, there was one customer that represented 18 % of the Company’s net sales in such year, and during the year ended December 31, 2024, there were two customers that represented 13 % and 10 %, respectively of the Company’s sales in such year. There was one customer that represented 13 % of the Company’s accounts receivable as of December 31, 2025, and there was one customer that represented 14 % of the Company’s accounts receivable as of December 31, 2024.
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, 2025 and 2024, the Company’s net income or loss equaled its comprehensive income or 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
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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 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. The prospective adoption of this guidance by the Company in the year ended December 31, 2025 did not have a material effect on its financial condition, results of operations or cash flows.
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. Divestiture of CIED Business
As described in Note 2, on October 1, 2025, the Company completed the sale of its CIED Business and the CIED Business met the criteria for reporting as discontinued operations in accordance with ASC 205-20 - Discontinued Operations . The related assets and liabilities of the CIED Business are classified as assets and liabilities of discontinued operations as of December 31, 2024 in the consolidated balance sheets and the results of operations from the CIED Business are reported as discontinued operations in the consolidated statements of operations for the years ended December 31, 2025 and 2024. Applicable amounts in the prior year have been recast to conform to this discontinued operations presentation.
The following tables shows the assets and liabilities of the discontinued operations as of December 31, 2024:
Carrying amounts of the major classes of assets included in discontinued operations:
Inventory
$
1,980
Total current assets
1,980
Property and equipment, net
102
Intangible assets, net
5,673
Operating lease right-of-use assets and other
730
Total non-current assets
6,505
Total assets of discontinued operations
$
8,485
Carrying amounts of the major classes of liabilities included in discontinued operations:
Current operating lease liabilities
$
315
Total current liabilities
315
Long-term operating lease liabilities
407
Total liabilities of discontinued operations
$
722
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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 for the years ended December 31, 2025 and 2024, with the year ended December 31, 2025 including the financial results from January 1, 2025 through the transaction closing date of October 1, 2025.
Year Ended
December 31,
2025
2024
Net sales
$
10,552
$
9,907
Cost of goods sold
6,096
5,918
Gross profit
4,456
3,989
Sales and marketing
7,208
7,554
General and administrative
421
584
Research and development
787
786
Total operating expenses
8,416
8,924
Interest expense
2,892
3,847
Gain on sale of CIED Business
( 76,273 )
—
Tax impact of gain on sale of CIED Business
170
—
Income (loss) from discontinued operations
$
69,251
$
( 8,782 )
Total operating and investing cash flows of discontinued operations for the years ended December 31, 2025 and 2024 are comprised of the following, with the year ended December 31, 2025 including the cash flows from January 1, 2025 through the transaction closing date of October 1, 2025:
Year Ended
December 31,
2025
2024
Significant operating non-cash reconciliation items:
Depreciation and amortization
$
1,569
$
2,368
Stock-based compensation
817
848
Changes in operating assets and liabilities:
Inventory
( 1,013 )
( 933 )
Operating lease right-of-use
257
344
Operating lease liabilities
( 231 )
( 348 )
Significant investing items:
Expenditures for property and equipment
( 27 )
—
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, 2025, the Company had 1,597,158 shares of Class A common stock available for issuance under the 2020 Plan, and on January 1, 2026, the shares available for issuance were increased by 1,711,394 pursuant to the automatic increase provisions of the plan.
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In March 2026, the Company established the Elutia Inc. 2026 Inducement Award Plan (the “Inducement Plan”) to attract, retain and motivate persons who are expected to make important contributions to the Company. Shares of Class A common stock totaling 2,000,000 are reserved for issuance pursuant to the Inducement 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, 2025 is as follows:
Weighted-
Average
Weighted-
Remaining
Aggregate
Average
Contractual
Intrinsic
Exercise
Term
Value
Number of Shares
Price
(years)
(in thousands)
Outstanding, December 31, 2024
3,220,991
$
5.23
7.3
$
475
Granted
503,781
$
1.39
Exercised
—
$
—
Forfeited
( 426,831 )
$
4.39
Outstanding, December 31, 2025
3,297,941
$
4.75
7.1
$
-
Vested and exercisable, December 31, 2025
2,195,285
$
5.43
6.5
$
-
As of December 31, 2025, there was approximately $ 1.5 million of total unrecognized compensation expense related to unvested stock options. These costs are expected to be recognized over a weighted-average period of 1.1 years. The weighted average grant date fair value of options granted during the years ended December 31, 2025 and 2024 were $ 1.13 and $ 2.38 , respectively. The total intrinsic value of options exercised during the year ended December 31, 2024 was not material.
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.
The following weighted-average assumptions were used to determine the fair value of options during the years ended December 31, 2025 and 2024:
Year Ended
December 31,
2025
2024
Expected term (years)
5.7
5.9
Risk-free interest rate
4.0
%
3.3
%
Volatility factor
107.1
%
84.2
%
Dividend yield
—
—
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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 EluPro. With the FDA’s clearance 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, 2025, 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 RSUs 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, 2025 is as follows:
Weighted-
Average
Number of Shares
Grant Date
Underlying RSUs
Fair Value
Unvested, December 31, 2024
1,417,123
$
3.58
Granted
155,000
$
2.55
Vested
( 821,197 )
$
3.56
Forfeited
( 24,121 )
$
3.67
Unvested, December 31, 2025
726,805
$
3.38
The total fair value of the RSUs granted during the years ended December 31, 2025 and 2024 was $ 0.4 million and $ 8.5 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, 2025, $ 1.6 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of 1.1 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 EluPro. With the FDA’s clearance 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 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, 2025, 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, 2025, the total shares of Class A common stock authorized for
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issuance under the ESPP was 1,126,448 , of which 763,965 remained available for future issuance. During the year ended December 31, 2025, 59,268 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, 2025 and 2024 was comprised of the following (in thousands):
Year Ended
December 31,
2025
2024
Sales and marketing
$
500
$
635
General and administrative
3,141
5,273
Research and development
578
964
Cost of goods sold
178
171
Total stock-based compensation expense
$
4,397
$
7,043
Note 6. Inventory
Inventory as of December 31, 2025 and 2024 was comprised of the following (in thousands):
December 31,
2025
2024
Raw materials
$
239
$
68
Finished goods
2,378
1,863
Total
$
2,617
$
1,931
Note 7. Property and Equipment
Property and equipment as of December 31, 2025 and 2024 were comprised of the following (in thousands):
December 31,
2025
2024
Processing and research equipment
$
1,285
$
673
Leasehold improvements
43
96
Office equipment and furniture
30
30
Computer hardware and software
73
93
Assets under construction
1,363
—
2,794
892
Less: accumulated depreciation and amortization
( 283 )
( 221 )
Property and equipment, net
$
2,511
$
671
Depreciation and amortization expense on property and equipment totaled approximately $ 0.1 million in both of the years ended December 31, 2025 and 2024. Amounts included within cost of goods sold are not material.
Note 8. Leases
As of December 31, 2025, the Company leases one administrative facility under a non-cancelable operating lease arrangement that expires in June 2028 and one administrative, research and production facility under a non-cancelable operating lease arrangement that expires in January 2036 with early termination options in May 2029 and May 2033.
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The following is a summary of the Company’s ROU assets and operating lease liabilities as of December 31, 2025 and 2024 (in thousands):
December 31,
Classification on the Balance Sheet
2025
2024
Assets
Operating leases assets
Operating lease right-of-use assets and other
$
2,426
$
154
Liabilities
Operating leases current liabilities
Current operating lease liabilities and other
355
145
Operating leases non-current liabilities
Long-term operating lease liabilities
3,587
16
Total lease liabilities
$
3,942
$
161
Weighted average remaining lease term
9.5
0.9
Weighted average discount rate
12.1
%
13.1
%
For the years ended December 31, 2025 and 2024, the Company recognized operating lease costs of approximately $ 0.5 million and $ 0.2 million, respectively. Cash paid for amounts included in the measurement of operating lease liabilities are included in operating cash flows and were approximately $ 0.1 million and $ 0.2 million for the years ended December 31, 2025 and 2024, respectively.
The table below reconciles the Company’s future cash obligations to the operating lease liabilities recorded on the balance sheet as of December 31, 2025 (in thousands):
Years ending December 31,
2026
$
202
2027
806
2028
759
2029
711
2030
732
Thereafter
4,076
Total minimum lease payments
7,286
Less: amount of lease payments representing interest
( 3,344 )
Present value of future minimum lease payments
3,942
Less: current operating lease liabilities
( 355 )
Long-term operating lease liabilities
$
3,587
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.
The components of identified intangible assets as of December 31, 2025 and 2024 are as follows (in thousands):
December 31, 2025
December 31, 2024
Accumulated
Accumulated
Cost
Amortization
Net
Cost
Amortization
Net
Acquired products
$
7,689
$
( 6,600 )
$
1,089
$
7,689
$
( 5,831 )
$
1,858
Customer relationships
3,070
( 2,630 )
440
3,070
( 2,328 )
742
Total
$
10,759
$
( 9,230 )
$
1,529
$
10,759
$
( 8,159 )
$
2,600
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Acquired products and customer relationships are both amortized over a ten-year period. Amortization expense totaled approximately $ 1.1 million for each of the years ended December 31, 2025 and 2024, which is included in Cost of goods sold in the accompanying consolidated statements of operations. Annual amortization expense is expected to be approximately $ 1.1 million during the year ending December 31, 2026 and approximately $ 0.4 million during the year ending 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 allowed for the establishment of a separate, new asset-based revolving loan facility of up to $ 8 million, which was not entered into before termination of the SWK Loan Facility, as described below. T he SWK Loan Facility also included both minimum revenue and liquidity covenants, restrictions as to payment of dividends, and was secured by all assets of the Company, subject to certain customary exceptions. See below for discussion of an amendment to the minimum liquidity covenant in May 2025.
All of the SWK Loan Facility borrowings took the form of Secured Overnight Financing Rate (“ SOFR ”) loans and bore 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 elected the PIK Interest option (as defined below), 3.75 % and the “Term SOFR Rate.” The Company could 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 could be made until November 15, 2025. The “Term SOFR Rate” was subject to a floor of 2.75 %. The agreement governing the SWK Loan Facility also included 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 12.5 % and 13.4 % for the years ended December 31, 2025 and 2024, respectively.
On August 10, 2022 (the “Closing Date”), the Company issued to SWK Funding LLC a warrant (“SWK 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 SWK 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 SWK Warrant are subject to adjustment in the event of stock dividends, stock splits and certain other events affecting the SWK common stock. Unless earlier exercised or terminated in accordance with its terms, the SWK Warrant will expire on the seventh anniversary of the Closing Date. Upon issuance, the Company valued the SWK Warrant at approximately $ 0.6 million using the Black-Scholes model. The recognition of the SWK Warrant as well as deferred financing costs of approximately $ 0.5 million incurred in securing the SWK Loan Facility served to reduce the recorded value of the associated debt. The debt discount and deferred financing costs are recognized as interest expense through the maturity of the loan.
In May 2025, Elutia entered into a fourth amendment (the “Fourth Amendment”) to the SWK Loan Facility. The Fourth Amendment, among other things: (i) allowed for 100 % of the interest payment due in May 2025 to be paid as PIK Interest, (ii) removed mandatory repayment obligations related to non-ordinary course asset sales, (iii) allowed the Company to request that SWK advance a new term loan in the amount of up to $ 5.0 million, which advance will be in the sole and absolute discretion of SWK and (iv) fixed the amount of the minimum liquidity covenant to be $ 8.0 million. In consideration for the Fourth Amendment, the Company agreed to issue SWK 50,000 shares of its Class A Common Stock in a private placement.
In August 2025, the Company entered into a fifth amendment (the “Fifth Amendment”) to the SWK Loan Facility, which, among other things, provided that the following amounts were capitalized into the unpaid principal balance of the SWK Loan Facility: (i) all accrued and unpaid interest due and owing to the lenders on the payment date in August 2025, (ii) a $ 50,000 amendment fee agreed to by the Company on June 30, 2025, and (iii) a $ 10,000 amendment fee to be paid pursuant to the Fifth Amendment.
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Prior to the May 2025 amendment described above, the SWK Loan Facility Agreement required 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 a 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.
On October 1, 2025, in connection with and through the proceeds of the sale of the Company’s CIED Business described in Note 2, Elutia fully repaid the SWK Loan Facility as required by the terms of the loan agreement. The outstanding principal, including the accrued exit fee, and accrued interest recognized as of this date totaled approximately $ 26.9 million. The total payment by the Company to SWK in full satisfaction of the debt was $ 27.8 million, yielding a loss on early repayment of debt of $ 1.3 million (including the write-off of the unamortized debt discount and deferred financing costs of $ 0.4 million) which is recorded within Other expense (income), net in the accompanying statement of operations.
As of December 31, 2024, the Company’s long-term debt was comprised of SWK Loan Facility balance, net of unamortized discount and deferred financing fees of $ 23.9 million less the current portion of $ 1.3 million resulting from 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.
In addition to the above, in 2024, the Company financed the annual premiums of certain insurance policies through short-term financing arrangements and included the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheet. 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, 2025 and 2024.
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 required 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.
In January 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 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. Total payments to Ligand during the year ended December 31, 2024 were $ 7.4 million.
In May 2025, Elutia entered into a subscription agreement and further amendment to the Amended Revenue Interest Obligation with Ligand. Through such amendment, $ 2.2 million in outstanding royalty obligations (royalty
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obligations for the quarters ended December 31, 2024 and March 31, 2025) owed by Elutia to Ligand under the Amended Revenue Interest Obligation was satisfied by the issuance of 1,105,528 shares of Elutia’s Class A common stock to Ligand in a transaction registered with the Securities and Exchange Commission. An additional cash payment to Ligand of $ 2.2 million was made in October 2025 in satisfaction of the royalty obligation for the quarters ended June 30, 2025 and September 30, 2025. Moreover, also in October 2025, a further amendment to the Amended Revenue Interest Obligation was executed which eliminated the provision that a $ 5.0 million milestone payment would be due if cumulative sales exceed $ 300 million or the assets related to CanGaroo and any substantially similar products undergo a change of control.
The Company records the present value of the estimated total future payments under both the Revenue Interest Obligation and Amended Revenue Interest Obligation as a long-term obligation, with the short-term portion being recorded as described below. 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 expense (income), net in the accompanying consolidated statement of operations. During the second quarter of 2025, the Company identified and corrected an accounting error related to the January 2024 amendment of the Revenue Interest Obligation. The Company inappropriately accounted for it under the catch-up method and recognized a gain instead of accounting for it as a modification. As a result, the Company recorded a gain of $ 1.4 million recognized in the first quarter of 2024 and overstated interest expense in the subsequent periods. The Company has determined that the error was not material to the current or any of the prior periods. However, as of the second quarter of 2025, the revenue interest obligation was understated by $ 0.8 million. As such, the Company corrected this as an out of period adjustment in June 2025 through a $ 1.4 million increase in Other expense (income), net to reverse the original gain and a reduction of $ 0.6 million in Interest (income) expense, net to reverse the overstatement of interest expense. The out of period correction is not material to the consolidated financial statements.
As of December 31, 2025 and 2024, the short-term portion of the Amended Revenue Interest Obligation is comprised of the annual minimum payments of $ 4.4 million.
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, 2024 Using:
Level 1
Level 2
Level 3
Total
Assets:
Money market fund
$
10,850
$
—
$
—
$
10,850
Total
$
10,850
$
—
$
—
$
10,850
Liabilities:
Warrant liability
$
—
$
16,076
$
—
$
16,076
Total
$
—
$
16,076
$
—
$
16,076
Fair Value Measurements at December 31, 2025 Using:
Level 1
Level 2
Level 3
Total
Assets:
Money market fund
$
32,786
$
—
$
—
$
32,786
Total
$
32,786
$
—
$
—
$
32,786
Liabilities:
Warrant liability
$
—
$
3,124
$
—
$
3,124
Total
$
—
$
3,124
$
—
$
3,124
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The warrant liability in the tables above consists of the fair value of 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants (as defined in Note 14 below) to purchase the Company’s Class A Common Stock. The prior year warrant liability was updated to be presented as a level 2 measurement as there was an observable input in determining its fair value. 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.
The following table provides a rollforward of the Revenue Interest Obligation categorized with Level 3 inputs for the years ended December 31, 2025 and 2024 (in thousands):
Revenue Interest Obligation
Balance, January 1, 2024
$
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
Payments on Revenue Interest Obligation
( 4,400 )
Interest accrued to Revenue Interest Obligation
295
Loss on revaluation of Revenue Interest Obligation
1,443
Balance, December 31, 2025
$
7,228
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 Company has elected to prospectively adopt the guidance in ASU No. 2023-09 (see Note 3). The reconciliation of the U.S. federal statutory rate to the consolidated effective tax rate for continuing operations as of December 31, 2025 is as follows:
Amount
Percent
Tax benefit at U.S. statutory rate
$
( 3,330 )
21.0
%
State income tax benefit, net of federal benefit*
( 379 )
2.4
%
Nondeductible expenses:
Revaluation of warrant liability
( 2,813 )
17.7
%
Excess tax deficiency from stock-based compensation
338
( 2.1 )
%
Other
62
( 0.4 )
%
Change in valuation allowance
6,135
( 38.7 )
%
Effective tax rate
$
13
( 0.1 )
%
*For the year ended December 31, 2025, the states of Alabama and Tennessee comprised greater than 50% of the state income tax benefit in this category.
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The reconciliation of the U.S. federal statutory rate to the consolidated effective tax rate as of December 31, 2024 is as follows:
Tax benefit at U.S. statutory rate
21.0
%
State income tax benefit, net of federal benefit
1.4
%
Nondeductible expenses
( 7.8 )
%
State law changes
0.2
%
Other
( 0.7 )
%
Change in valuation allowance
( 14.2 )
%
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 carryforwards. The significant components of the Company’s net deferred income taxes are as follows (in thousands):
December 31,
2025
2024
Deferred tax assets:
Tax goodwill
$
2,497
$
2,549
Net operating loss carryforwards
27,277
29,733
Inventory
46
94
Acquired intangibles
720
2,000
Revenue interest obligation
476
631
Interest expense
2,646
4,485
Research and development costs
-
2,375
Operating lease liability
919
193
Litigation costs
1,606
3,713
Other
2,606
2,262
Total assets
38,793
48,035
Deferred tax liabilities:
Operating lease right-to-use assets
( 425 )
( 188 )
Prepaid expenses
( 561 )
( 441 )
Total liabilities
( 986 )
( 629 )
Total net deferred tax asset
37,807
47,406
Valuation allowance
( 37,807 )
( 47,406 )
Net deferred tax asset, net of valuation allowance
$
—
$
—
During the year ended December 31, 2025, the Company realized the value of deferred tax assets totaling $ 9.6 million and the corresponding valuation allowance was reversed in connection with its taxable income generated from the gain on sale of its CIED Business. The Company did not recognize any deferred benefit for income taxes for the years ended December 31, 2024 as the increases to the net deferred tax asset of $ 8.4 million was 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, 2025 and 2024, the Company has provided valuation allowances against all deferred tax assets.
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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, 2025 and 2024 relates to current amounts due on certain state tax obligations. Furthermore, state taxes totaling $ 0.2 million related to the gain on sale of the CIED Business is recorded within Income (loss) from Discontinued Operations in the accompanying consolidated statements of operations. During the year ended December 31, 2025, the Company’s income taxes paid (net of refunds received) was not material.
As of December 31, 2025, the Company had remaining net operating loss carryforwards for federal income tax purposes of approximately $ 118.6 million, comprised of $ 6.6 million that will expire beginning in 2038 and 112.0 million that have no expiration date. The Company also had state net operating loss carryforwards of approximately $ 42.4 million that will expire beginning in 2031. 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. If the Company has experiences a change of control, as defined by Section 382, 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.
In July 2025, the One Big Beautiful Bill Act (OBBBA) was enacted into law. The OBBBA amends U.S. tax laws, including provisions related to bonus depreciation and deductions for research and development expenses. The OBBBA accelerated the deductibility of the Company’s previously capitalized research and development expenses..
As of December 31, 2025 and 2024, the Company had no unrecognized tax benefits.
Note 14. Common Stock and Warrants
Registered Direct Offerings of Common Stock and Warrants
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. The Company incurred transaction fees, including commissions and legal fees, of approximately $ 1.3 million in connection with the 2025 Registered Offering, of which $ 1.2 million were allocated to the issuance of the common stock.
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 2024 Registered Offering, of which $ 1.1 million were allocated to the issuance of the common stock.
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
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(“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 EluPro, 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 the 2025 Registered Offering, 2024 Registered Offering and Private Offering.
Warrant Liabilities
The Company has concluded that the 2025 Prefunded Warrants from the 2025 Registered Offering, the 2024 Prefunded Warrants from the 2024 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 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, the Company allocated a portion of the gross proceeds from the respective offerings to the related warrants based on their fair values and have recorded such amounts as a Warrant liability in the accompanying consolidated balance sheets as of December 31, 2025 and December 31, 2024. Additionally, the Company allocated a portion of the transaction fees from the 2024 Registered Offering, 2025 Registered Offering and the Private Offering to the respective warrants and recognized the expense within Other expense (income), net. Such expenses totaled $ 0.1 million and $ 0.3 million for the years ended December 31, 2025 and 2024, respectively.
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 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants is recorded as Warrant liability in the accompanying consolidated balance sheet as of December 31, 2025 and December 31, 2024. A summary of the warrant activity for the years ended December 31, 2025 and 2024, respectively is as follows:
Common Warrants
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Outstanding, January 1, 2024
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
—
Issued
—
—
—
480,000
Exercised
—
( 250,000 )
—
—
Outstanding, December 31, 2025
—
3,323,326
725,000
480,000
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The valuation of the warrants is adjusted to fair value 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, 2025 and 2024, respectively (in thousands):
Common Warrants
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Total Offering Warrants
Warrant Liability, January 1, 2024
$
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
Fair value upon issuance
—
—
—
1,200
1,200
Gain on revaluation of warrant liability
—
( 10,345 )
( 2,211 )
( 868 )
( 13,424 )
Exercised
—
( 728 )
—
—
( 728 )
Warrant Liability, December 31, 2025
$
—
$
2,292
$
500
$
332
$
3,124
The Company has used the price of its Class A Common Stock to estimate the fair value of the 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants at each measurement date. The price of the Company’s Class A Common Stock approximates fair value of the 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants due to the exercise price per share of $ 0.001 . As such warrants utilize quoted prices for the Company’s Class A common stock (similar assets in the active market), their fair valuation is deemed to be “Level 2” within the fair value hierarchy. The fair value adjustments have been recorded as (Gain) loss on revaluation of warrant liability in the accompanying consolidated statements of operations.
The Company had previously calculated the fair value of the Common Warrants immediately before exercise using the Black-Scholes option pricing model with the following inputs as of September 30, 2024:
Common stock price
$
4.96
Expected term (years)
0.1
Risk-free interest rate
5.5
%
Volatility factor
88.4
%
Dividend yield
—
%
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 for both the years ended December 31, 2025 and 2024, respectively. Matching contributions are a component of employee compensation. Accrued employee compensation as of December 31, 2025 and 2024 totaled $ 2.4 million and $ 2.2 million, respectively and is included in Accrued Expenses in the accompanying consolidated balance sheets.
Note 16. Net Income (Loss) Per Share
Net income (loss) per share is computed by dividing net income (loss) by the weighted average number of shares of common stock outstanding during the period. Diluted net income (loss) per share is computed by dividing net income (loss), adjusted for gains on the revaluation of warrant liability (see Note 14), by the weighted average number of shares of common stock outstanding during the period, adjusted for the potential dilutive effect of the Company’s prefunded warrants (see Note 14), outstanding stock options, outstanding RSUs, and shares issuable under the ESPP. The treasury stock method was used to calculate the potential dilutive effect of these common stock equivalents.
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Year Ended
(in thousands, except share and per share data)
December 31,
2025
2024
Numerator:
Net loss from continuing operations
$
( 15,871 )
$
( 45,345 )
Income (loss) from discontinued operations
69,251
( 8,604 )
Net income (loss)
53,380
( 53,949 )
Less: dilutive gain on revaluation of warrant liability
( 13,424 )
—
Net income (loss) for dilutive earnings per share
$
39,956
$
( 53,949 )
Denominator:
Weighted average number of common shares - basic
41,416,850
29,071,113
Effect of dilutive prefunded warrants
4,525,937
—
Weighted average number of common shares - diluted
45,942,787
29,071,113
Net loss from continuing operations per share - basic
$
( 0.38 )
$
( 1.56 )
Net loss from continuing operations per share - diluted
$
( 0.64 )
$
( 1.56 )
Net income (loss) from discontinued operations per share - basic
$
1.67
$
( 0.30 )
Net income (loss) from discontinued operations per share - diluted
$
1.51
$
( 0.30 )
Net income (loss) per share - basic
$
1.29
$
( 1.86 )
Net income (loss) per share - diluted
$
0.87
$
( 1.86 )
Certain of 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. The Company excluded 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,
2025
2024
Options to purchase common stock
3,297,941
3,220,991
Restricted stock units
726,805
1,417,123
Class A common stock warrants
187,969
187,969
2023 Prefunded Warrants
—
3,573,326
2024 Prefunded Warrants
—
725,000
2025 Prefunded Warrants
—
—
Total
4,212,715
9,124,409
Note 17. Commitment and Contingencies
Cook Biotech License and Supply Agreements
In 2017, Elutia 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 Cardiovascular, CanGaroo and EluPro products, subject to certain co-exclusive rights retained by Cook. Along with this license agreement, Elutia entered into a supply agreement whereby Cook would be the exclusive supplier to Elutia of licensed porcine tissue. On October 1, 2025, in connection with the sale of the CIED Business described in Note 2, the Company entered into amendments to both the license (the “Amended License Agreement”) and supply agreements such that the Amended License Agreement removed all products divested with the sale of the CIED Business and includes only the Company’s remaining Cardiovascular products. Both agreements expire on December 31, 2028. 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. No royalties were due or paid to Cook during the year ended December 31, 2025 or 2024. The Amended License
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Agreement includes a final license fee payment of $ 0.1 million to be paid by the Company in October 2026. The Company, in its sole discretion, can terminate the Amended 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, 2025, five lawsuits or claims are active, 104 have been settled and one case where the statute of limitations to file a lawsuit has expired. Of the 104 cases that have settled, 35 have not yet been fully paid due to one or more scheduled payments being made after December 31, 2025. The unsettled lawsuits 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 remaining lawsuits were filed in the Superior Court of Marion County, Indiana (collectively, the “Indiana Complaints”) and the Court of Common Pleas, Philadelphia County (“Pennsylvania Complaint).
Plaintiffs in the Indiana 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. The Pennsylvania 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 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, 28 product liability lawsuits or claims have been filed or asserted against the Company involving VBM. As of December 31, 2025, 11 lawsuits or claims are active, 16 have been settled and one case has been dismissed. Of the settled cases, thirteen have been fully paid and three have not yet been paid as of December 31, 2025. Furthermore, there are four potential claims where the statute of limitation to file a lawsuit has expired. The unsettled 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
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(collectively, the “California State Complaints”), the United States District Court for the Southern District of California (collectively, the “California Federal Complaints”), the United States District Court for the Eastern District of Louisiana (collectively, the “Louisiana Federal Complaint”), the United States District Court for the Western District of Texas (the “Texas Federal Complaint”), the United States District Court for the Western District of Michigan (the “Michigan Federal Complaint”), the Circuit Court of the State of Oregon (the “Oregon State Complaint”) and the United States District Court for the Southern District of New York (the “New York Complaint”).
Plaintiffs in the California State Complaints and California Federal Complaints 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. Plaintiff in the Louisiana Federal Complaint asserts causes of action under the Louisiana Product Liability Act citing unreasonably dangerous construction or composition, unreasonably dangerous design, and inadequate warning. Plaintiff in this action also alleges claims for breach of implied warranty, breach of express warranty, and negligence. 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. Plaintiffs in the Oregon State Complaint assert causes of action for negligence, lack of informed consent, medical battery, and loss of consortium. Plaintiffs in the Michigan Federal Complaint assert causes of action for negligence and gross negligence. Plaintiffs in the New York Complaint assert causes of action for negligence, strict liability and breach of implied warranty.
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 operative 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 defend and indemnify the Company for over 100 lawsuits against the Company alleging claims arising from the use of FiberCel products distributed by Medtronic and that Medtronic concealed and misrepresented an insurance policy potentially applicable to those FiberCel-related lawsuits. 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 September 19, 2025, Medtronic filed a partial motion to dismiss some of the claims in Elutia’s current complaint. Elutia filed an opposition to that motion, and Medtronic filed a reply brief. The court set a hearing for the motion for February 20, 2026, and its decision on the partial motion to dismiss is expected after the hearing. Discovery is ongoing in the case. Given the early stages of this matter and the Company’s intention to vigorously defend Medtronic’s counterclaim, we do not consider a loss to be probable or estimable at this time.
Tiger Litigation
On October 21, 2025, Tiger Aesthetics Medical, LLC (“Tiger”) filed an action against Elutia in the Superior Court of the State of Delaware. The Complaint alleges breach of contract and related claims related to the 2023 distribution agreement (the “Tiger Distribution Agreement”) between the Company and Tiger as well as the August 2025 letter of intent (the “Tiger LOI”) for the possible sale by the Company to Tiger of certain assets and rights. The complaint does not specify the amount of any alleged damages. On November 13, 2025, Elutia filed a motion to dismiss. Tiger filed an opposition to that motion, and Elutia filed a reply brief. A hearing on the Company’s motion to dismiss is scheduled for March 23, 2025. Given the early stages of this matter and the Company’s intention to vigorously defend against Tiger’s
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claims, Elutia does not consider a loss to be probable or estimable at this time. Elutia terminated the Tiger Distribution Agreement effective October 25, 2025. Additionally, the Tiger LOI expired on October 25, 2025.
Supplier Litigation
In October 2024, a former lab and safety equipment supplier filed a lawsuit in California Superior Court (Contra Costa County) against the Company and two co-defendants. The complaint alleges breach of contract and related equitable claims based on a 2014 agreement that the supplier claims automatically renewed in 2023 for an 84-month term. The lawsuit seeks specified damages. On April 1, 2025, the Company filed an answer denying the allegations in the complaint and asserting affirmative defenses. The court has set a trial for January 2027. Given the early stages of this matter and the Company’s intention to vigorously defend the case, 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, through December 31, 2025, settlement agreements have been reached in 104 of the cases and full or partial settlement payments of $ 28.8 million have been made by Elutia, with $ 9.6 million of such total settlement outlays having been paid through insurance proceeds. As of December 31, 2025, the Company has a total liability for FiberCel Litigation of $ 6.8 million which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. Such liability includes $ 5.8 million for 35 cases in which the settlements have been reached but had not yet been fully paid and $ 1.0 million for the five cases which have not yet been settled or adjudicated and for which the Company has estimated a probable loss for those cases as of December 31,2025.
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, through December 31, 2025, settlement agreements have been reached in 16 of the cases and settlement payments of $ 1.5 million have been made by Elutia, all of which has been paid through insurance proceeds.
As of December 31, 2025, the Company has a total liability for VBM Litigation of $ 4.4 million which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. Such liability includes $ 1.0 million for three cases in which settlements have been reached but had not yet been paid and the remaining 15 cases, including unasserted claims that the Company believes are probable of assertion, and for which an estimation of probable loss is required as of year-end. 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
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(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.
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 probable amounts 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 both December 31, 2025 and 2024 totaled $ 4.8 million and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets.
As of December 31, 2025, all amounts recorded as Insurance Receivables of Litigation Costs relate to the VBM Litigation, and additional insurance remains available to cover the future cost of the VBM Litigation and related defense costs. Conversely, the Company has no more insurance to cover the cost of the FiberCel Litigation and the related defense costs.
As of both December 31, 2025 and 2024, 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 the matters involving Medtronic, Tiger and a former supplier.
Note 18. Segment Information
With the divestiture of the CIED Business, the Company now operates in two segments. The Company determined its operating and reportable segments to be consistent with its major product groupings – 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.
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For the year ended December 31, 2025, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
9,138
$
3,155
$
12,293
Cost of goods sold, excluding intangible asset amortization
3,986
634
4,620
Segment gross profit
$
5,152
$
2,521
$
7,673
The net sales for the year ended December 31, 2025 include the revenues derived from one customer which represents 18 % of total net sales. Such customer is included within the Women’s Health segment.
For the year ended December 31, 2024, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
11,553
$
2,914
$
14,467
Cost of goods sold, excluding intangible asset amortization
5,568
1,107
6,675
Segment gross profit
$
5,985
$
1,807
$
7,792
The net sales for the year ended December 31, 2024 include the revenues derived from one customer which represents 13 % of total net sales. Such customer is included within the Women’s Health segment. The net sales for the year ended December 31, 2024 also 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, 2025 and 2024 (in thousands):
Year Ended
December 31,
2025
2024
Segment gross profit
$
7,673
$
7,792
Adjustments:
Intangible asset amortization expense
1,077
1,077
Sales and marketing
5,765
4,988
General and administrative
15,080
18,073
Research and development
4,163
2,998
Litigation costs, net
8,499
11,368
Loss from operations
( 26,911 )
( 30,712 )
Interest expense
( 387 )
934
Loss on revaluation of warrant liability
( 13,424 )
14,878
Other (income) expense, net
2,758
( 1,186 )
Loss from continuing operations before provision for income taxes
$
( 15,858 )
$
( 45,338 )
During the years ended December 31, 2025 and 2024, the Company did not have any material international product sales, and the Company did not own any long-lived assets outside the United States.
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