Item 1. Financial Statements
Item 1. Financial Statements.
ELUTIA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except for Share and Per Share Data)
(UNAUDITED)
March 31,
December 31,
2026
2025
Assets
Current assets:
Cash and cash equivalents
$
28,488
$
36,350
Accounts receivable, net
2,068
1,734
Inventory
2,657
2,617
Insurance receivables of litigation costs
5,348
4,846
Prepaid expenses and other current assets
2,030
2,271
Divestiture proceeds receivables
8,000
8,000
Total current assets
48,591
55,818
Property and equipment, net
2,909
2,511
Intangible assets, net
1,260
1,529
Operating lease right-of-use assets and other
2,449
2,492
Total assets
$
55,209
$
62,350
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
3,870
$
4,791
Accrued expenses
5,815
4,352
Current portion of revenue interest obligation
5,500
4,400
Contingent liability for legal proceedings
8,016
11,241
Current operating lease liabilities
524
355
Total current liabilities
23,725
25,139
Long-term revenue interest obligation
1,873
2,828
Warrant liability
3,389
3,124
Long-term operating lease liabilities
3,695
3,587
Total liabilities
32,682
34,678
Commitments and contingencies (Note 9)
Stockholders’ equity (deficit):
Class A Common stock, $ 0.001 par value per share, 200,000,000 shares authorized as of March 31, 2026 and December 31, 2025, and 44,208,236 and 42,784,848 shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
44
43
Class B Common stock, $ 0.001 par value per share, 20,000,000 shares authorized as of March 31, 2026 and December 31, 2025, and no shares issued and outstanding as of March 31, 2026 and December 31, 2025, respectively
—
—
Additional paid-in capital
206,165
203,842
Accumulated deficit
( 183,682 )
( 176,213 )
Total stockholders’ equity
22,527
27,672
Total liabilities and stockholders' equity
$
55,209
$
62,350
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ELUTIA INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In Thousands, Except Share and Per Share Data)
(UNAUDITED)
Three Months Ended
March 31,
2026
2025
Net sales
$
3,114
$
2,951
Cost of goods sold
1,312
1,569
Gross profit
1,802
1,382
Sales and marketing
1,480
995
General and administrative
4,091
3,721
Research and development
1,973
871
Litigation costs, net
606
2,572
Total operating expenses
8,150
8,159
Loss from continuing operations
( 6,348 )
( 6,777 )
Interest (income) expense, net
( 108 )
184
Loss (gain) on revaluation of warrant liability
1,655
( 5,187 )
Other (income) expense, net
( 71 )
105
Loss from continuing operations before provision for income taxes
( 7,824 )
( 1,879 )
Income tax expense
70
8
Net loss from continuing operations
( 7,894 )
( 1,887 )
Income (loss) from discontinued operations
425
( 2,046 )
Net loss
( 7,469 )
( 3,933 )
Less: dilutive gain on revaluation of warrant liability
—
( 5,201 )
Net loss for dilutive earnings per share
$
( 7,469 )
$
( 9,134 )
Net loss from continuing operations per share - basic
$
( 0.18 )
$
( 0.05 )
Net loss from continuing operations per share - diluted
$
( 0.18 )
$
( 0.17 )
Net income (loss) from discontinued operations per share - basic
$
0.01
$
( 0.05 )
Net income (loss) from discontinued operations per share - diluted
$
0.01
$
( 0.05 )
Net loss per share - basic
$
( 0.17 )
$
( 0.10 )
Net loss per share - diluted
$
( 0.17 )
$
( 0.21 )
Weighted average common shares outstanding - basic
42,998,504
38,616,207
Weighted average common shares outstanding - diluted
42,998,504
42,913,111
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ELUTIA INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(In Thousands, Except Share Amounts)
(UNAUDITED)
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, 2025
42,784,848
$
43
—
$
—
$
203,842
$
( 176,213 )
$
27,672
Exercise of stock options
1,875
—
—
—
2
—
2
Issuance of common stock under Employee Stock Purchase Plan
48,841
—
—
—
45
—
45
Vesting of restricted stock units, net of shares withheld and taxes paid
73,904
—
—
—
( 44 )
—
( 44 )
Stock-based compensation
—
—
—
—
931
—
931
Warrants exercise, net of administrative costs
1,298,768
1
—
—
1,389
—
1,390
Net loss
—
—
—
—
—
( 7,469 )
( 7,469 )
Balance, March 31, 2026
44,208,236
$
44
—
$
—
$
206,165
$
( 183,682 )
$
22,527
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 $1.2 million
5,520,000
5
—
—
12,590
—
12,595
Issuance of common stock under Employee Stock Purchase Plan
31,558
—
—
—
80
—
80
Vesting of restricted stock units, net of shares withheld and taxes paid
103,558
1
—
—
( 152 )
—
( 151 )
Stock-based compensation
—
—
—
—
1,211
—
1,211
Net loss
—
—
—
—
—
( 3,933 )
( 3,933 )
Balance, March 31, 2025
36,552,348
$
37
4,313,406
$
4
$
197,027
$
( 233,526 )
$
( 36,458 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ELUTIA INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In Thousands)
(UNAUDITED)
Three Months Ended
March 31,
2026
2025
Net loss
$
( 7,469 )
$
( 3,933 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
330
868
Gain on sale of Orthobiologics Business
( 425 )
—
Loss (gain) on revaluation of warrant liability
1,655
( 5,187 )
Amortization of deferred financing costs and debt discount
—
53
Interest expense recorded as additional revenue interest obligation and long-term debt
145
702
Stock-based compensation
931
1,211
Changes in right-of-use assets and lease liabilities and lease incentives received
320
( 103 )
Changes in operating assets and liabilities:
Accounts receivable
( 334 )
( 584 )
Inventory
( 40 )
( 375 )
Receivables of litigation costs
( 502 )
867
Prepaid expenses and other
241
449
Accounts payable and accrued expenses
542
( 225 )
Contingent liability for legal proceedings
( 3,225 )
( 2,624 )
Net cash used in operating activities
( 7,831 )
( 8,881 )
INVESTING ACTIVITIES:
Proceeds from sale of Orthobiologics Business
425
—
Expenditures for property and equipment
( 459 )
( 278 )
Net cash used in investing activities
( 34 )
( 278 )
FINANCING ACTIVITIES:
Proceeds from direct registered offering and warrants, net of offering costs
—
13,796
Repayments of insurance premium financings
—
( 446 )
Payments for taxes upon vesting of restricted stock units
( 44 )
( 152 )
Proceeds from stock option exercises and issuance of common stock under ESPP
47
80
Net cash provided by financing activities
3
13,278
Net (decrease) increase in cash and cash equivalents
( 7,862 )
4,119
Cash and cash equivalents, beginning of period
36,350
13,239
Cash and cash equivalents, end of period
$
28,488
$
17,358
Supplemental Cash Flow and Non-Cash Financing Activities Disclosures:
Cash paid for interest
$
—
$
526
Conversion of Prefunded Warrants to common stock
$
1,390
$
—
The accompanying notes are an integral part of these condensed consolidated financial statements.
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ELUTIA INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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 unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements and accompanying notes included in the Company's annual report on Form 10-K (“2025 Annual Report”) for the fiscal year ended December 31, 2025. The financial information as of March 31, 2026 and for the three months ended March 31, 2026 and 2025 is unaudited, but in the opinion of management, all adjustments considered necessary for a fair statement of the results for these interim periods have been included. The condensed consolidated balance sheet data as of December 31, 2025 was derived from audited financial statements but does not include all disclosures required by GAAP. The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or any future year or period.
The condensed 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 constituted 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 provided 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 fourth quarter of 2025. Such gain included the recognition of the $ 8.0 million in escrow as a divestiture proceeds receivable on the accompanying balance sheet as of March 31, 2026.
The sale of the CIED Business represented 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
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(“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 $ 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 three months ended March 31, 2026 or 2025. 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. In March 2026, the indemnity holdback was resolved with Berkeley remitting $ 0.4 million to Elutia. Such amount was recognized as additional gain in the first quarter of 2026 within income (loss) from discontinued operations in the accompanying condensed consolidated financial statements. 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 three months ended March 31, 2026, the Company incurred a loss from continuing operations of $ 7.9 million, and as of March 31, 2026, the Company had an accumulated deficit of $ 183.7 million. In addition, during the three months ended March 31, 2026, the Company used $ 7.8 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 9 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 March 31, 2026 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
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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 three months ended March 31, 2025, 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 12. Additionally, certain prior period amounts have been reclassified to conform to current period presentation.
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 of preferred stock have been issued or are outstanding as of March 31, 2026 and December 31, 2025. During the year ended December 31, 2025, all outstanding shares of Class B common stock were converted to Class A common stock.
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 11 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.
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Level 3 - Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.
The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature.
Cash and Cash Equivalents
The Company maintains its cash and cash equivalent balances at banks and financial institutions. The balances are insured up to the legal limit. The Company maintains cash and cash equivalent balances that may, at times, exceed this insured limit. The Company considers cash on hand, demand deposits in a bank, money market funds, and all highly liquid investments with an original maturity of 90 days or less to be cash and cash equivalents.
Accounts Receivable and Allowances
Accounts receivable in the accompanying balance sheets are presented net of allowances for credit losses. The Company grants credit to customers in the normal course of business, but generally does not require collateral or any other security to support its receivables.
The Company evaluates the collectability of accounts receivable based on a combination of factors. In circumstances where a specific customer is unable to meet its financial obligations to the Company, a provision to the allowance for doubtful accounts is recorded to reduce the net recognized receivable to the amount that is reasonably expected to be collected. For all other customers, a provision to the allowance for credit losses is recorded based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience. Provisions to the allowance for doubtful accounts are recorded to general and administrative expenses. Account balances are charged off against the allowance when it is probable that the receivable will not be recovered.
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.
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Leases
In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No 2016-02, Leases to increase the transparency and comparability about leases among entities. ASU 2016-02 and certain additional ASUs are now codified as ASC 842, Leases . ASC 842 supersedes the lease accounting guidance in ASC 840 and requires lessees to recognize a lease liability and a corresponding lease asset for virtually all lease contracts. The Company determines if an arrangement contains a lease at inception. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from that lease. For leases with a term 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 computed over the estimated useful lives of the respective assets.
The Company periodically evaluates the period of depreciation or amortization for long-lived assets to determine whether current circumstances warrant revised estimates of useful lives. The Company reviews its property and equipment and intangible assets for impairment whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Impairment exists when the carrying value of the company’s asset exceeds the related estimated undiscounted future cash flows expected to be derived from the asset. If impairment exists, the carrying value of that asset is adjusted to its fair value. A discounted cash flow analysis is used to estimate an asset’s fair value, using assumptions that market participants would apply. The results of impairment tests are subject to management’s estimates and assumptions of projected cash flows and operating results. Changes in assumptions or market conditions could result in a change in estimated future cash flows and could result in a lower fair value and therefore an impairment, which could impact reported results. There were no impairment losses for the three months ended March 31, 2026 or 2025.
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, June 2024 registered direct offering and 2025 registered direct offering (see Note 8) 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 Loss (gain) loss on revaluation of warrant liability in the condensed 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
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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 agents. For these types of product sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized.
The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in sales and marketing costs.
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 individual institutions may at times exceed the federally insured limits.
For the three months ended March 31, 2026, there was one customer that represented 14 % of the Company’s accounts receivable, and during the year ended December 31, 2025, there was one customer that represented 13 % of the Company’s accounts receivable.
Comprehensive Income (Loss)
Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the three months ended March 31, 2026 and 2025, the Company’s net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented.
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Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences on future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized.
The Company is subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more likely than not (greater than 50%) of being realized upon settlement. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense.
Note 3. Recently Issued Accounting Standards
In November 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. Accordingly, the CIED Business is reported as discontinued operations in accordance with ASC 205-20 - Discontinued Operations and the amounts for the three months ended March 31, 2025 have been recast to conform to this discontinued operations presentation.
In accordance with ASC 205-20, only expenses specifically identifiable and related to a business to be disposed are presented in discontinued operations. Additionally, since the repayment of the Company’s SWK Loan Facility (see Note 7) was deemed to be contractually required as part of the CIED Business sale, interest expense on the repaid SWK Loan Facility is also classified within discontinued operations. The following table shows the financial results of the discontinued operations for the three months ended March 31, 2025:
Net sales
$
3,079
Cost of goods sold
1,998
Gross profit
1,081
Sales and marketing
2,042
General and administrative
150
Research and development
34
Total operating expenses
2,226
Interest expense
901
Net loss
$
( 2,046 )
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Total operating and investing cash flows of discontinued operations for the three months ended March 31, 2025 are comprised of the following:
Significant operating non-cash reconciliation items
Depreciation and amortization
$
594
Stock-based compensation
123
Changes in operating assets and liabilities:
Inventory
( 206 )
Prepaid expenses and other
83
Other liabilities
( 74 )
Significant investing items
Expenditures for property and equipment
( 7 )
See Note 2 for discussion of the financial results of discontinued operations recognized for the three months ended March 31, 2026 which relates to the Company’s sale of its Orthobiologics Business.
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 initial public offering (“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 March 31, 2026, the Company had 810,198 shares of Class A common stock available for issuance under the 2020 Plan.
In March 2026, the Company established the Elutia Inc. 2026 Inducement Award Plan (the “2026 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 2026 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 generally have contractual terms of ten years and vest over a four-year period from the date of grant.
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A summary of stock option activity under the Company’s 2015 Plan, 2020 Plan and 2026 Inducement Plan for the three months ended March 31, 2026 is as follows:
Weighted-
Average
Weighted-
Remaining
Aggregate
Average
Contractual
Intrinsic
Exercise
Term
Value
Number of Shares
Price
(years)
(in thousands)
Outstanding, December 31, 2025
3,297,941
$
4.75
7.1
$
-
Granted
3,039,000
$
0.75
Exercised
( 1,875 )
$
0.69
Forfeited
( 109,897 )
$
4.44
Outstanding, March 31, 2026
6,225,169
$
2.81
8.4
$
945
Vested and exercisable, March 31, 2026
2,299,401
$
5.18
6.7
$
37
As of March 31, 2026, there was approximately $ 2.9 million of total unrecognized compensation expense related to unvested stock options. These costs are expected to be recognized over a weighted-average period of 2.7 years.
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 time-based options granted during the three months ended March 31, 2026:
Expected term (years)
6.0
Risk-free interest rate
3.8
Volatility factor
105.5
Dividend yield
—
There were no options granted during the three months ended March 31, 2025.
The Company has also granted stock options that vest 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 March 31, 2026, there were a total of 345,011 stock options outstanding that are market condition stock option awards.
Restricted Stock Units
Restricted stock units (“RSUs”) represent rights to receive common shares at a future date. There is no exercise price, and no monetary payment is required for receipt of restricted stock units or the shares issued in settlement of the award.
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A summary of the RSU activity under the Company’s 2020 Plan for the three months ended March 31, 2026 is as follows:
Weighted-
Average
Number of Shares
Grant Date
Underlying RSUs
Fair Value
Unvested, December 31, 2025
726,805
$
3.38
Granted
30,000
$
1.22
Vested
( 113,426 )
$
3.40
Forfeited
( 749 )
$
3.61
Unvested, March 31, 2026
642,630
$
3.28
The total fair value of the RSUs granted during the three months ended March 31, 2026 was approximately $ 0.1 million. 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 March 31, 2026, $ 1.2 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of 1.0 years.
The Company has granted RSUs that vest 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 March 31, 2026, 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 its 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 March 31, 2026, the total shares of Class A common stock authorized for issuance under the ESPP was 1,554,296 , of which 1,142,972 remained available for future issuance.
Stock-Based Compensation Expense
Stock-based compensation expense recognized during the three months ended March 31, 2026 and 2025 was comprised of the following (in thousands):
Three Months Ended
March 31,
2026
2025
Sales and marketing
$
43
$
66
General and administrative
715
859
Research and development
173
143
Cost of goods sold
-
20
Total stock-based compensation expense
$
931
$
1,088
Stock-based compensation expense included within discontinued operations totaled $ 0.1 million for the three months ended March 31, 2025.
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Note 6. Inventory
Inventory as of March 31, 2026 and December 31, 2025 was comprised of the following (in thousands):
March 31,
December 31,
2026
2025
Raw materials
$
373
$
239
Finished goods
2,284
2,378
Total
$
2,657
$
2,617
Note 7. 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”). 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) in the fourth quarter of 2025. The weighted average interest rate on the SWK Loan Facility was 12.7 % for the three months ended March 31, 2025.
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.
Note 8. Revenue Interest Obligation
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 (the “CorMatrix Acquisition”). As part of the CorMatrix Acquisition, the Company assumed a restructured, long-term royalty obligation (the “Revenue Interest Obligation”) to Ligand Pharmaceuticals Incorporated (“Ligand”) with an estimated present value on the acquisition date of $ 27.7 million. On January 10, 2024, the Company entered into an amendment to the Revenue Interest Obligation (the “Amended Revenue Interest Obligation”). Pursuant to the Amended Revenue Interest Obligation, subject to annual minimum payments of $ 4.4 million per year, the terms of the Revenue Interest Obligation require Elutia to pay Ligand 5 % of future sales of the products Elutia acquired from CorMatrix, including CanGaroo, ProxiCor, Tyke and VasCure, as well as products substantially similar to those products, such as EluPro. Furthermore, a $ 5.0 million payment would be due to Ligand if cumulative sales exceed $ 300 million during the ten-year term of the agreement which expires on May 31, 2027.
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 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.
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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 condensed consolidated statements of operations using the catch-up method. There was no change to estimated future payments during the three months ended March 31, 2026 and 2025, and thus, no re-measurement gain or loss was recognized. Interest expense related to the Revenue Interest Obligation of approximately $ 0.1 million and $ 0.3 million was recorded for the three months ended March 31, 2026 and 2025, respectively.
As of March 31, 2026, the short-term portion of the Amended Revenue Interest Obligation which totals $ 5.5 million is comprised of the annual minimum payments of $ 4.4 million plus the unpaid $ 1.1 million quarterly minimum payment related to the fourth quarter of 2025. As of December 31, 2025, the short-term portion of the Amended Revenue Interest Obligation is comprised of the annual minimum payments of $ 4.4 million.
Note 9. Common Stock and Warrants
Registered Direct Offering 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 (“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.
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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 March 31, 2026 and December 31, 2025. 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 for the three months ended March 31, 2025.
As noted above, the last exercise date for the Common Warrants was July 31, 2024. All Common Warrants outstanding were exercised by such date. 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 March 31, 2026 and December 31, 2025.
A summary of the warrant activity for the three months ended March 31, 2026 is as follows:
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Outstanding, December 31, 2025
3,323,326
725,000
480,000
Exercised
( 1,300,000 )
—
—
Outstanding, March 31, 2026
2,023,326
725,000
480,000
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 three months ended March 31, 2026 (in thousands):
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Total Offering Warrants
Warrant liability, December 31, 2025
$
2,292
$
500
$
332
$
3,124
Loss on revaluation of warrant liability
1,221
261
173
1,655
Exercised
( 1,390 )
-
-
( 1,390 )
Warrant liability, March 31, 2026
$
2,123
$
761
$
505
$
3,389
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 Loss (gain) on revaluation of warrant liability in the accompanying condensed consolidated statements of operations.
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Note 10. Commitments 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 three months ended March 31, 2026 or 2025. The Amended License 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
As previously disclosed, 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 March 31, 2026, four lawsuits or claims are active, 105 have been settled and there is one case where the statute of limitations to file a lawsuit has expired. Of the 105 cases that have settled, 30 have not yet been fully paid due to one or more scheduled payments being made after March 31, 2026. 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 and the Court of Common Pleas, Philadelphia County. The Company refers to the aforementioned litigation and claim notices collectively as the “FiberCel Litigation.”
Viable Bone Matrix Litigation
As also previously disclosed, 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 March 31, 2026, 10 lawsuits or claims are active, 17 have been settled and one case has been dismissed. Of the settled cases, thirteen have been fully paid and four have not yet been paid as of March 31, 2026. 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
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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, the United States District Court for the Southern District of California, the United States District Court for the Eastern District of Louisiana, the United States District Court for the Western District of Texas, the United States District Court for the Western District of Michigan, the Circuit Court of the State of Oregon and the United States District Court for the Southern District of New York. The Company refers to all of the aforementioned litigation, or 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 (“Partial Motion”) to dismiss some of the claims in Elutia’s current complaint. Elutia filed an opposition to that Partial Motion, and Medtronic filed a reply brief. The court’s previously set hearing date for the Partial Motion of February 20, 2026 was vacated and has not been rescheduled. The court’s 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. Tiger’s original complaint alleged 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. In March 2026, the Superior Court granted Elutia’s motion to dismiss the complaint in part. On April 15, 2026, Tiger filed an amended complaint asserting three claims relating only to the Tiger LOI. Elutia has not yet filed a response to the amended complaint. Given the early stages of this matter and the Company’s intention to vigorously defend against Tiger’s 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 March 31, 2026, settlement agreements have been reached in 105 of the cases
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and full or partial settlement payments of $ 32.2 million have been made by Elutia, with $ 9.6 million of such total settlement outlays having been paid through insurance proceeds. As of March 31, 2026, the Company has a total liability for FiberCel Litigation of $ 3.6 million which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. Such liability includes $ 2.7 million for 30 cases in which the settlements have been reached but had not yet been fully paid and $ 0.9 million for the four cases which have not yet been settled or adjudicated and for which the Company has estimated a probable loss.
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 March 31, 2026, settlement agreements have been reached in 17 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 March 31, 2026, 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 $ 1.5 million for four cases in which settlements have been reached but had not yet been paid and the remaining 14 cases, including unasserted claims that the Company believes are probable of assertion, for which an estimation of probable loss is required as of March 31, 2026. The expense related to this estimate was recorded within Litigation costs, net in the accompanying consolidated statement of operations, with the entirety of such expense offset by insurance recoveries received or receivable as further described below.
In order to reasonably estimate the liability for the unsettled VBM Litigation cases and unasserted claims, the Company, along with outside legal counsel, has assessed a variety of factors, including (i) the extent of the injuries incurred, (ii) recent experience on the settled claims, (iii) settlement offers made to the other parties to the litigation and (iv) any other factors that may have a material effect on the VBM Litigation. While the Company believes its estimated liability to be reasonable, the actual loss amounts are highly variable and are dependent upon the relevant facts and case-by-case resolutions. As more information is learned about asserted and unasserted claims and potential future trends, adjustments may be made to this Contingent Liability for Legal Proceedings as appropriate. Management believes that it is reasonably possible that the Company could incur liabilities in excess of amounts accrued and the ultimate liability could be material to the Company’s financial position, results of operations and cash flows in the period recognized. The Company, however, is unable to estimate the possible loss or range of loss in excess of the amount recognized at this time.
Defense costs for both the FiberCel Litigation and VBM Litigation are recognized in the accompanying consolidated statements of operations as incurred, with the entirety of such expense related to the VBM Litigation offset by insurance recoveries received or receivable as further described below.
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
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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 March 31, 2026 totaled $ 5.3 million and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets.
As of March 31, 2026, 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 March 31, 2026 and 2025, 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 11. 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 9), 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 9), 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.
Three Months Ended
(in thousands, except share and per share data)
March 31,
2026
2025
Numerator:
Net loss from continuing operations
$
( 7,894 )
$
( 1,887 )
Income (loss) from discontinued operations
425
( 2,046 )
Net loss
( 7,469 )
( 3,933 )
Less: dilutive gain on revaluation of warrant liability
—
( 5,201 )
Net loss for diluted earnings per share
$
( 7,469 )
$
( 9,134 )
Denominator:
Weighted average number of common shares - basic
42,998,504
38,616,207
Effect of dilutive common and prefunded warrants
—
4,296,904
Weighted average number of common shares - diluted
42,998,504
42,913,111
Net loss from continuing operations per share - basic
$
( 0.18 )
$
( 0.05 )
Net loss from continuing operations per share - diluted
$
( 0.18 )
$
( 0.17 )
Net income (loss) from discontinued operations per share - basic
$
0.01
$
( 0.05 )
Net income (loss) from discontinued operations per share - diluted
$
0.01
$
( 0.05 )
Net loss per share - basic
$
( 0.17 )
$
( 0.10 )
Net loss per share - diluted
$
( 0.17 )
$
( 0.21 )
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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:
Three Months Ended
March 31,
2026
2025
Options to purchase common stock
6,225,169
3,204,215
Restricted stock units
642,630
1,342,766
Class A common stock warrants
187,969
187,969
2023 Prefunded Warrants
2,023,326
—
2024 Prefunded Warrants
725,000
—
2025 Prefunded Warrants
480,000
480,000
Total
10,284,094
5,214,950
Note 12. 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.
For the three months ended March 31, 2026, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
2,089
$
1,025
$
3,114
Cost of goods sold, excluding intangible asset amortization
891
151
1,042
Segment gross profit
$
1,198
$
874
$
2,072
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For the three months ended March 31, 2025, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
2,625
$
326
$
2,951
Cost of goods sold, excluding intangible asset amortization
1,173
127
1,300
Segment gross profit
$
1,452
$
199
$
1,651
No customer exceeded 10% of the Company’s total net sales for the three months ended March 31, 2026. One customer in the Women’s Health segment, Tiger, represented 32 % of total net sales for the three months ended March 31, 2025. The Company distribution agreement with Tiger was terminated effective October 2025.
The following table is a reconciliation of segment gross profit to the consolidated loss before provision for income taxes for the three months ended March 31, 2026 and 2025, (in thousands):
Three Months Ended
March 31,
2026
2025
Segment gross profit
$
2,072
$
1,651
Adjustments:
Intangible asset amortization expense
( 270 )
( 269 )
Sales and marketing
( 1,480 )
( 995 )
General and administrative
( 4,091 )
( 3,721 )
Research and development
( 1,973 )
( 871 )
Litigation costs, net
( 606 )
( 2,572 )
Loss from operations
( 6,348 )
( 6,777 )
Interest (income) expense, net
( 108 )
184
Loss (gain) on revaluation of warrant liability
1,655
( 5,187 )
Other (income) expense, net
( 71 )
105
Loss from continuing operations before provision for income taxes
$
( 7,824 )
$
( 1,879 )
During the three months ended March 31, 2026 and 2025, 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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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.