Item 1. Financial Statements
Item 1. Financial Statements.
ELUTIA INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except for Share and Per Share Data)
(UNAUDITED)
September 30,
December 31,
2025
2024
Assets
Current assets:
Cash and cash equivalents
$
4,721
$
13,239
Accounts receivable, net
3,553
2,276
Inventory
2,011
1,931
Insurance receivables of litigation costs
4,561
4,760
Prepaid expenses and other current assets
539
1,986
Current assets of discontinued operations
2,993
1,980
Total current assets
18,378
26,172
Property and equipment, net
2,054
671
Intangible assets, net
1,800
2,600
Operating lease right-of-use assets and other
2,565
179
Noncurrent assets of discontinued operations
4,610
6,505
Total assets
$
29,407
$
36,127
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable
$
6,598
$
4,149
Accrued expenses
7,274
7,104
Current portion of long-term debt
5,000
1,250
Current portion of revenue interest obligation
5,500
4,400
Contingent liability for legal proceedings
16,383
20,432
Current operating lease liabilities
222
145
Current liabilities of discontinued operations
357
315
Total current liabilities
41,334
37,795
Long-term debt
21,103
22,603
Long-term revenue interest obligation
3,910
5,490
Warrant liability
4,030
16,076
Long-term operating lease liabilities
2,814
16
Noncurrent liabilities of discontinued operations
134
407
Total liabilities
73,325
82,387
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 September 30, 2025 and December 31, 2024, and 40,198,920 and 30,897,232 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
40
31
Class B Common stock, $ 0.001 par value per share, 20,000,000 shares authorized as of September 30, 2025 and December 31, 2024, and 2,351,246 and 4,313,406 shares issued and outstanding as of September 30, 2025 and December 31, 2024, respectively
2
4
Additional paid-in capital
203,044
183,298
Accumulated deficit
( 247,004 )
( 229,593 )
Total stockholders’ deficit
( 43,918 )
( 46,260 )
Total liabilities and stockholders' deficit
$
29,407
$
36,127
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
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Net sales
$
3,323
$
3,662
$
9,022
$
11,651
Cost of goods sold
1,470
1,871
4,340
6,258
Gross profit
1,853
1,791
4,682
5,393
Sales and marketing
1,601
1,241
3,863
3,791
General and administrative
3,519
4,340
10,792
13,828
Research and development
1,088
702
2,948
2,271
Litigation costs, net
853
4,683
7,429
8,757
Total operating expenses
7,061
10,966
25,032
28,647
Loss from operations
( 5,208 )
( 9,175 )
( 20,350 )
( 23,254 )
Interest expense, net
265
131
( 42 )
796
(Gain) loss on revaluation of warrant liability
( 5,098 )
( 12,653 )
( 12,518 )
15,321
Other expense (income), net
—
—
1,547
( 1,186 )
Income (loss) before provision for income taxes
( 375 )
3,347
( 9,337 )
( 38,185 )
Income tax expense
8
8
24
5
Net income (loss) from continuing operations
( 383 )
3,339
( 9,361 )
( 38,190 )
Loss from discontinued operations
( 3,485 )
( 2,053 )
( 8,050 )
( 6,698 )
Net income (loss)
( 3,868 )
1,286
( 17,411 )
( 44,888 )
Less: Undistributed net income to participating securities
—
( 219 )
—
—
Net income (loss) attributable to common stockholders
$
( 3,868 )
$
1,067
$
( 17,411 )
$
( 44,888 )
Net income (loss) attributable to common stockholders from continuing operations per share - basic
$
( 0.01 )
$
0.10
$
( 0.23 )
$
( 1.41 )
Net loss per share attributable to common stockholders from continuing operations per share - diluted
$
( 0.12 )
$
( 0.27 )
$
( 0.48 )
$
( 1.41 )
Net income (loss) attributable to common stockholders from discontinued operations per share - basic
$
( 0.08 )
$
( 0.06 )
$
( 0.20 )
$
( 0.25 )
Net income (loss) attributable to common stockholders from discontinued operations per share - diluted
$
( 0.07 )
$
( 0.06 )
$
( 0.18 )
$
( 0.25 )
Net income (loss) attributable to common stockholders per share - basic
$
( 0.09 )
$
0.03
$
( 0.43 )
$
( 1.65 )
Net loss attributable to common stockholders per share - diluted
$
( 0.19 )
$
( 0.33 )
$
( 0.66 )
$
( 1.65 )
Weighted average common shares outstanding - basic
42,431,314
32,520,134
40,965,925
27,132,216
Weighted average common shares outstanding - diluted
46,957,199
35,520,938
45,492,271
27,132,216
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, June 30, 2025
38,081,935
$
38
4,313,406
$
4
$
201,251
$
( 243,136 )
$
( 41,843 )
Issuance of common stock under Employee Stock Purchase Plan
27,710
—
—
—
32
—
32
Vesting of restricted stock units, net of shares withheld and taxes paid
127,115
—
—
—
( 58 )
—
( 58 )
Stock-based compensation
—
—
—
—
1,981
—
1,981
Conversion of Class B Common Stock to Class A Common Stock
1,962,160
2
( 1,962,160 )
( 2 )
—
—
—
Exercise of Prefunded Warrants
—
—
—
—
( 162 )
—
( 162 )
Net loss
—
—
—
—
—
( 3,868 )
( 3,868 )
Balance, September 30, 2025
40,198,920
$
40
2,351,246
$
2
$
203,044
$
( 247,004 )
$
( 43,918 )
Balance, June 30, 2024
23,963,101
$
24
4,313,406
$
4
$
157,452
$
( 221,818 )
$
( 64,338 )
Exercises of Common Warrants
5,771,655
5
—
—
21,630
—
21,635
Issuance of common stock under Employee Stock Purchase Plan and exercise of stock options
33,159
—
—
—
92
—
92
Vesting of restricted stock units, net of shares withheld and taxes paid
480,777
1
—
—
( 689 )
—
( 688 )
Stock-based compensation
—
—
—
—
1,775
—
1,775
Net income
—
—
—
—
—
1,286
1,286
Balance, September 30, 2024
30,248,692
$
30
4,313,406
$
4
$
180,260
$
( 220,532 )
$
( 40,238 )
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, 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
6
—
—
12,590
—
12,596
Issuance of common stock as payment under revenue interest obligation
1,105,528
1
—
—
2,199
—
2,200
Issuance of common stock as payment of interest
50,000
—
—
—
83
—
83
Conversion of Class B Common Stock to Class A Common Stock
1,962,160
2
( 1,962,160 )
( 2 )
—
—
—
Exercise of Prefunded Warrants
249,910
—
—
—
727
—
727
Issuance of common stock under Employee Stock Purchase Plan
59,268
—
—
—
112
—
112
Vesting of restricted stock units, net of shares withheld and taxes paid
354,822
—
—
—
( 307 )
—
( 307 )
Stock-based compensation
—
—
—
—
4,342
—
4,342
Net loss
—
—
—
—
—
( 17,411 )
( 17,411 )
Balance, September 30, 2025
40,198,920
$
40
2,351,246
$
2
$
203,044
$
( 247,004 )
$
( 43,918 )
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
Exercises of Common Warrants and Prefunded Warrants
7,399,144
7
—
—
27,736
—
27,743
Issuance of common stock under Employee Stock Purchase Plan and exercise of stock options
98,618
—
—
—
162
—
162
Vesting of restricted stock units, net of shares withheld and taxes paid
691,734
1
—
—
( 1,011 )
—
( 1,010 )
Stock-based compensation
—
—
—
—
6,683
—
6,683
Net loss
—
—
—
—
—
( 44,888 )
( 44,888 )
Balance, September 30, 2024
30,248,692
$
30
4,313,406
$
4
$
180,260
$
( 220,532 )
$
( 40,238 )
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)
Nine Months Ended
September 30,
2025
2024
Net loss
$
( 17,411 )
$
( 44,888 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
2,488
2,588
Gain on sale of Orthobiologics Business
—
( 180 )
(Gain) loss on revaluation of warrant liability
( 12,518 )
15,321
Gain on revaluation of revenue interest obligation
—
( 1,443 )
Amortization of deferred financing costs and debt discount
161
162
Interest expense recorded as additional revenue interest obligation and long-term debt
3,892
2,086
Stock-based compensation
4,342
6,683
Bad debt expense
—
251
Changes in operating assets and liabilities:
Accounts receivable
( 1,277 )
81
Inventory
( 1,093 )
220
Receivables of litigation costs
199
( 1,886 )
Prepaid expenses and other
1,898
2,171
Accounts payable and accrued expenses
3,308
( 984 )
Contingent liability for legal proceedings
( 4,049 )
9,265
Other liabilities
64
153
Net cash used in operating activities
( 19,996 )
( 10,400 )
INVESTING ACTIVITIES:
Proceeds from sale of Orthobiologics Business
—
180
Expenditures for property and equipment
( 1,022 )
( 560 )
Net cash used in investing activities
( 1,022 )
( 380 )
FINANCING ACTIVITIES:
Proceeds from private placement and warrants, net of offering costs
13,796
12,390
Repayments of long-term debt
—
( 2,000 )
Proceeds from exercises of Common Warrants and Prefunded Warrants
—
15,725
Payments on revenue interest obligation
—
( 6,300 )
Repayments of insurance premium financings
( 1,101 )
( 1,721 )
Payments for taxes upon vesting of restricted stock units
( 307 )
( 1,011 )
Proceeds from stock option exercises and issuance of common stock under ESPP
112
162
Net cash provided by financing activities
12,500
17,245
Net increase (decrease) in cash and cash equivalents
( 8,518 )
6,465
Cash and cash equivalents, beginning of period
13,239
19,276
Cash and cash equivalents, end of period
$
4,721
$
25,741
Supplemental Cash Flow and Non-Cash Financing Activities Disclosures:
Cash paid for interest
$
560
$
4,421
Issuance of common stock as payment under revenue interest obligation
$
2,200
$
—
Additions to operating lease right-of-use assets
$
2,271
$
1,379
Conversion of Common Warrants and Prefunded Warrants to common stock
$
727
$
17,576
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 leveraging its unique understanding of biologics combined with local drug delivery to improve the interaction between implanted medical devices and patients by reducing complications associated with these surgeries. The Company has developed a portfolio of products using both human and porcine tissue that are designed to be as close to natural biological material as possible. Elutia’s portfolio of products spans the Women’s Health and Cardiovascular markets. These products are primarily sold to healthcare providers or commercial partners.
On November 7, 2025, the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”), notifying us that, for the last 30 consecutive business days, the closing bid price for our Class A common stock, par value $ 0.001 per share (the “Common Stock”), was below $ 1.00 per share, which is the minimum closing bid price (the “Minimum Bid Price”) required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Notice”). The Notice provided a compliance period of 180 calendar days from the date of the Notice, or until May 6, 2026 (the “Compliance Period”), to regain compliance with the Minimum Bid Price requirement.
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 (“Annual Report”) for the fiscal year ended December 31, 2024. The financial information as of September 30, 2025 and for the three and nine months ended September 30, 2025 and 2024 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, 2024 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 “Buyers”). On October 1, 2025, at the closing of the transactions contemplated by the APA, the 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 held in Elutia’s Device Protection segment. The Buyers are only assuming 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 million in cash,
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with $ 80.3 million (which included a preliminary inventory adjustment of $ 0.3 million) that was paid in cash to Elutia at the closing of the transactions and $ 8 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 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 as of September 30, 2025. 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 Condensed 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 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 nine months ended September 30, 2025 or 2024. Additionally, the purchase agreement provides for a customary indemnity holdback in the amount of $ 1.5 million to be retained by Berkeley for 24 months after closing. In the purchase agreement, the Company has retained the liabilities arising out of the VBM and FiberCel matters, as described in Note 9, 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. The indemnity holdback is available as a source of recovery for Berkeley for claims of indemnification under the purchase agreement, and some or all of the holdback may be retained by Berkeley if Berkeley is successful in asserting a claim or claims for indemnification against the Company. The Company is aware of certain indemnity-related claims raised, including a claim from a former supplier alleging breach of contract. Based on the Company’s ongoing assessment of these claims, along with the remaining indemnity holdback of $ 1.5 million, the Company does not consider a loss to be probable or estimable as of September 30, 2025. Should the Company receive incremental proceeds in the future through an earn-out payment or payment of the holdback amount, an additional gain will be recorded upon the receipt of such amounts.
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, general 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 nine months ended September 30, 2025, the Company incurred a net loss of $ 17.4 million, and as of September 30, 2025, the Company had an accumulated deficit of $ 247.0 million. In addition, during the nine months ended September 30, 2025, the Company used $ 20.0 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 8 or pursue asset sales or other transactions, such as the sale of the CIED and Orthobiologics Businesses described
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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 condensed consolidated financial statements are issued. The Company believes that its existing cash and cash equivalents as of September 30, 2025, along with the proceeds received on October 1, 2025 from the sale of its CIED Business, net of repayment of the SWK debt in conjunction with the sale, will be sufficient to fund its operating expenses and capital expenditure requirements through at least one year after the issuance date of the condensed 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 three and nine months ended September 30, 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 12.
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.
Basic net 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. Net loss is not allocated to participating securities as they do not have an obligation to fund losses. For purposes of the diluted net loss per share calculation, stock options, restricted stock units (“RSUs”) and warrants are considered to be common stock equivalents. See Note 10 for further discussion of net loss per share attributable to common stockholders.
Fair Value of Financial Instruments
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:
Level 1 - Valuations based on quoted prices for identical assets and liabilities in active markets.
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Level 2 - Valuations based on observable inputs other than quoted prices included in Level 1, such as quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data.
Level 3 - Valuations based on unobservable inputs reflecting the Company’s own assumptions, consistent with reasonably available assumptions made by other market participants. These valuations require significant judgment.
The estimated fair value of financial instruments disclosed in the financial statements has been determined by using available market information and appropriate valuation methodologies. The carrying value of all current assets and current liabilities approximates fair value because of their short-term nature.
Cash and Cash Equivalents
The Company maintains its cash balances at banks and financial institutions. The balances are insured up to the legal limit. The Company maintains cash 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 purchased materials, direct labor and manufacturing overhead, is stated at the lower of cost or net realizable value, with cost determined generally using the average cost method. At each balance sheet date, the Company also evaluates inventory for excess quantities, obsolescence or shelf-life expiration. This evaluation includes 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 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 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. The Company uses the rate implicit in the lease to discount lease payments to present value unless that rate is not readily determinable. In the case the implicit rate is not readily determinable, 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.
In March 2025, the Company executed a new lease for 26,598 square feet in Gaithersburg, Maryland. The lease expires in January 2036 with early termination dates in 2029 and 2033. Monthly lease payments (including allocation portions of property taxes, insurance and other landlord operating expenses) total approximately $ 75,000 with annual rent escalations of 3 %. Rent is abated for the first 12 months of occupancy and is discounted at 50 % for months 13 through 18. The property was made available for use to Elutia by the landlord in May 2025 and at that time, the Company recognized an ROU asset and liability of $ 2.3 million on the Company’s condensed consolidated balance sheet using an incremental borrowing rate of 12.1 %. The Company moved its executive offices to this new location in May 2025. The Company is currently using the new facility for administrative purposes along with laboratory space for product development and anticipates using this facility for commercial production of certain new products, to the extent that marketing authorization for such new products is obtained.
As part of the Company’s divestiture of its CIED Business, Elutia’s lease in Roswell, Georgia was assigned to BSC. See Note 4 for further discussion of the assets and liabilities divested with the sale and their reporting as assets and liabilities of discontinued operations in the accompanying condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024.
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 nine months ended September 30, 2025 or 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, 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
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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 net 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 or commercial partners. Revenue is recognized when the Company has met its performance obligations pursuant to its contracts with its customers in an amount that the Company expects to be entitled to in exchange for the transfer of control of the products to the Company’s customers. For all product sales, the Company has no further performance obligations and revenue is recognized at the point control transfers, which occurs either when: i) the product is shipped via common carrier; or ii) the product is delivered to the customer or distributor, in accordance with the terms of the agreement.
A portion of the Company’s product revenue is generated from consigned inventory maintained at hospitals and from inventory physically held by distributors and direct sales representatives. For these types of product sales, the Company retains control until the product has been used or implanted, at which time revenue is recognized.
The Company elected to account for shipping and handling activities as a fulfillment cost rather than a separate performance obligation. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of the underlying products is transferred to the customer. The related shipping and freight charges incurred by the Company are included in sales and marketing costs.
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.
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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.
There was one customer that represented 14 % of the Company’s accounts receivable as of December 31, 2024. No customer represented greater than 10% of the Company’s accounts receivable as of September 30, 2025.
Comprehensive Income (Loss)
Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the nine months ended September 30, 2025 and 2024, the Company’s net loss equaled its comprehensive loss and accordingly, no additional disclosure is presented.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Deferred income taxes are recorded to reflect the tax consequences on future years for differences between the tax basis of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to amounts that are more likely than not to be realized.
The Company is subject to income taxes in the federal and state jurisdictions. Tax regulations within each jurisdiction are subject to the interpretation of the related tax laws and regulations and require significant judgment to apply. In accordance with the authoritative guidance on accounting for uncertainty in income taxes, the Company recognizes tax liabilities for uncertain tax positions when it is more likely than not that a tax position will not be sustained upon examination and settlement with various taxing authorities. Liabilities for uncertain tax positions are measured based upon the largest amount of benefit that is more likely than not (greater than 50%) of being realized upon settlement. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense.
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. Upon adoption, the impact of the OBBBA was not material to the Company’s condensed consolidated financial statements; however, the Company is assessing the impact of the OBBBA on the projected taxable gain on the sale of its CIED Business in the fourth quarter of 2025.
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. Early adoption is permitted. The Company does not expect the adoption of this guidance to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-09.
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Topic 220-40). This update assesses the disaggregation of income statement expense which requires more detailed information about specified categories of expenses included in certain expense captions presented on the face of the income statement. The amendments are effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for reporting periods after the effective date of this ASU or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2024-03.
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Note 4. Divestiture of CIED Business
As described in Note 2, o n September 8, 2025, the Company executed the APA for the sale of its CIED Business and the CIED Business met the criteria for held-for-sale classification as of September 30, 2025 and is reported 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 September 30, 2025 and December 31, 2024 in the condensed consolidated balance sheets and the results of operations from the CIED Business are reported as discontinued operations in the condensed consolidated statements of operations for the three and nine months ended September 30, 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:
September 30,
December 31,
2025
2024
Carrying amounts of the major classes of assets included in discontinued operations:
Inventory
2,993
1,980
Total current assets
2,993
1,980
Property and equipment, net
71
102
Intangible assets, net
4,067
5,673
Operating lease right-of-use and other assets
472
730
Total non-current assets
4,610
6,505
Total assets of discontinued operations
$
7,603
$
8,485
Carrying amounts of the major classes of liabilities included in discontinued operations:
Current operating lease liabilities
357
315
Total current liabilities
357
315
Long-term operating lease liabilities
134
407
Total liabilities of discontinued operations
$
491
$
722
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:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Net sales
$
3,958
$
2,259
$
10,552
$
7,256
Cost of goods sold
2,177
1,311
6,086
4,268
Gross profit
1,781
948
4,466
2,988
Sales and marketing
2,974
1,745
7,522
5,833
General and administrative
1,022
180
1,315
437
Research and development
287
77
787
681
Total operating expenses
4,283
2,002
9,624
6,951
Interest expense
983
999
2,892
2,915
Net loss
$
( 3,485 )
$
( 2,053 )
$
( 8,050 )
$
( 6,878 )
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Total operating and investing cash flows of discontinued operations for the nine months ended September 30, 2025 and 2024 are comprised of the following:
Nine Months Ended
September 30,
2025
2024
Significant operating non-cash reconciliation items
Depreciation and amortization
1,569
1,777
Stock-based compensation
892
804
Changes in operating assets and liabilities:
Inventory
( 1,013 )
( 834 )
Prepaid expenses and other
257
278
Other liabilities
( 231 )
( 358 )
Significant investing items
Expenditures for property and equipment
( 27 )
—
The divestiture of the CIED Business was completed pursuant to the APA on October 1, 2025.
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 September 30, 2025, the Company had 1,352,707 shares of Class A common stock available for issuance under the 2020 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.
A summary of stock option activity under the Company’s 2015 Plan and 2020 Plan for the nine months ended September 30, 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
331,865
$
1.65
Exercised
—
$
—
Forfeited
( 21,087 )
$
5.01
Outstanding, September 30, 2025
3,531,769
$
4.90
7.1
$
-
Vested and exercisable, September 30, 2025
2,373,419
$
5.48
6.5
$
-
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As of September 30, 2025, there was approximately $ 1.8 million of total unrecognized compensation expense related to unvested stock options. These costs are expected to be recognized over a weighted-average period of 1.2 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 nine months ended September 30, 2025 and 2024:
Nine Months Ended
September 30,
2025
2024
Expected term (years)
5.5
5.9
Risk-free interest rate
4.0
%
3.3
%
Volatility factor
107.2
%
100.9
%
Dividend yield
—
—
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 September 30, 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 restricted stock units or the shares issued in settlement of the award.
A summary of the RSU activity under the Company’s 2020 Plan for the nine months ended September 30, 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
( 707,269 )
$
3.58
Forfeited
( 13,498 )
$
3.71
Unvested, September 30, 2025
851,356
$
3.39
The total fair value of the RSUs granted during the nine months ended September 30, 2025 was $ 0.4 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 .
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As of September 30, 2025, $ 2.2 million of unrecognized compensation costs related to RSUs is expected to be recognized over a weighted average period of 1.3 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 September 30, 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 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 September 30, 2025, the total shares of Class A common stock authorized for issuance under the ESPP was 1,126,448 , of which 763,965 remained available for future issuance. During the nine months ended September 30, 2025, shares of Class A common stock totaling 59,268 were issued under the ESPP.
Stock-Based Compensation Expense
Stock-based compensation expense recognized during the three and nine months ended September 30, 2025 and 2024 was comprised of the following (in thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Sales and marketing
$
265
$
112
387
493
General and administrative
771
1,196
2,406
4,330
Research and development
196
257
539
1,008
Cost of goods sold
103
( 35 )
118
50
Total stock-based compensation expense
$
1,335
$
1,530
$
3,450
$
5,881
Stock-based compensation expense included within discontinued operations totaled $ 0.6 million and $ 0.2 million for the three months ended September 30, 2025 and 2024 and totaled $ 0.9 million and $ 0.8 million, respectively for the nine months ended September 30, 2025 and 2024, respectively.
Note 6. Inventory
Inventory as of September 30, 2025 and December 31, 2024 was comprised of the following (in thousands):
September 30,
December 31,
2025
2024
Raw materials
$
48
$
68
Finished goods
1,963
1,863
Total
$
2,011
$
1,931
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”). 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
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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. As of September 30, 2025, Elutia was in compliance with its financial covenants under the agreement governing the SWK Loan Facility (“SWK Loan Facility Agreement”). 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 12.3 % and 13.5 % for the three months ended September 30, 2025 and 2024 and 12.5 % and 13.5 % for the nine months ended September 30, 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 would have been 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 us on June 30, 2025, and (iii) a $ 10,000 amendment fee to be paid pursuant to the Fifth Amendment.
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.
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Long-term debt was comprised of the following (in thousands):
September 30,
December 31,
2025
2024
Term Loan Facility, net of unamortized discount and deferred financing costs
$
26,103
$
23,853
Current Portion
( 5,000 )
( 1,250 )
Long-Term Debt
$
21,103
$
22,603
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 $ 26.5 million. The total payment by the Company to SWK in full satisfaction of the debt was $ 27.8 million.
In addition to the above, the Company finances the annual premiums of certain insurance policies through short-term financing arrangements and includes the liabilities associated with such arrangements within accrued liabilities in accompanying consolidated balance sheets. The fair value of all debt instruments, which is based on inputs considered to be Level 2 under the fair value hierarchy, approximates the respective carrying values as of September 30, 2025 and December 31, 2024.
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 connection with the execution of the Amended Revenue Interest Obligation, 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. 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 fiscal 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. No additional payments to Ligand have been made during the nine months ended September 30, 2025. Total payments to Ligand during the nine months ended September 30, 2024 were $ 6.3 million comprised of the aforementioned 2023 amounts due and a 2024 quarterly minimum payments of $ 2.2 million.
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. 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 first quarter of 2024. The resulting gain was recognized as other income in the accompanying condensed 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
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Company inappropriately recorded a gain instead of accounting for the amendment 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 expense, net” to reverse the overstatement of interest expense. The out of period correction is not material to the condensed consolidated financial statements.
Interest expense related to the Revenue Interest Obligation of approximately $ 0.3 million and $ 0.4 million was recorded for the three months ended September 30, 2025 and 2024, respectively and approximately $ 0.3 million (net of the corrections noted above) and $ 1.3 million was recorded for the nine months ended September 30, 2025 and 2024, respectively.
On October 1, 2025, in connection with sale of the CIED Business described in Note 2, Ligand and the Company further amended the Amended Revenue Interest Obligation. Such amendment primarily consisted of a consent to the sale of the CIED Business and a release by Ligand of its security and royalty interest in the assets of the CIED Business including the EluPro and CanGaroo products. The Company’s annual minimum payment requirements of $ 4.4 million per year remain unchanged. In partial consideration of Ligand entering into the amendment, Elutia paid $ 1.1 million in accrued unpaid royalty obligations to Ligand.
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 the Company’s EluPro product, at an exercise price per share of
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$ 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 outstanding 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants 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 2025 Prefunded Warrants, 2024 Prefunded Warrants and 2023 Prefunded Warrants based on their fair values and have recorded such amounts as a warrant liability in the accompanying condensed consolidated balance sheet as of September 30, 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 for the nine months ended September 30, 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 yielding exercise proceeds of $ 13.8 million in July 2024. Certain of these exercises ultimately resulted in their conversion to 2023 Prefunded Warrants.
A summary of the warrant activity for the nine months ended September 30, 2025 is as follows:
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Outstanding, December 31, 2024
3,573,326
725,000
—
Issued
—
—
480,000
Exercised
( 250,000 )
—
—
Outstanding, September 30, 2025
3,323,326
725,000
480,000
The valuation of the warrants is adjusted to fair value (Level 3) at each subsequent balance sheet date until the warrants are settled. The following table provides a rollforward of the aggregate fair value of the warrant liability for the nine months ended September 30, 2025 (in thousands):
2023 Prefunded Warrants
2024 Prefunded Warrants
2025 Prefunded Warrants
Total Offering Warrants
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
( 9,680 )
( 2,066 )
( 772 )
( 12,518 )
Exercised
( 728 )
-
-
( 728 )
Warrant liability, September 30, 2025
$
2,957
$
645
$
428
$
4,030
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 . The fair value adjustments, which include a $ 5.1 million gain recognized during the three months ended September 30, 2025, have been recorded as (gain) loss on revaluation of
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warrant liability in the accompanying condensed consolidated statements of operations for the three and nine months ended September 30, 2025.
The Company had previously calculated the fair value of the Common Warrants 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
—
%
Class B Common Stock
During the third quarter of 2025, 1,962,160 shares of the Company’s Class B common stock were converted by the holder to voting Class A common stock.
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 nine months ended September 30, 2025 or 2024. The Amended License Agreement includes license fee payments of $ 0.1 million to be paid by the Company in October 2025 and 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 (“FiberCel”). Since September 2021, 110 product liability lawsuits or claims have been filed or asserted against the Company involving FiberCel. As of September 30, 2025, there were 44 active lawsuits or claims against the Company, including 38 lawsuits or claims where settlements have been reached but had not yet been paid by quarter-end and six lawsuits which have not yet been settled or adjudicated. The lawsuits, which have been filed against Elutia, certain Medtronic entities, and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered
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substantial symptoms and complications following the implantation of FiberCel during orthopedic fusion operations. Such lawsuits were filed in various U.S. federal courts and in state courts in Indiana, Pennsylvania, Delaware, Florida, Maryland and Ohio. The Company refers to all of the aforementioned litigation, or 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 (the “VBM Recall”). 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. As of September 30, 2025, there were 13 active lawsuits or claims filed or asserted against the Company. The lawsuits, which have been filed against Elutia and others, allege that the plaintiffs were exposed to and/or contracted tuberculosis and/or suffered substantial symptoms and complications following the implantation of VBM during orthopedic fusion operations. Such lawsuits were filed in various U.S. federal courts and in the California state court. 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 to dismiss some of the claims in Elutia’s current complaint. On October 17, 2025, Elutia filed an opposition to that motion. The court has not set a hearing or rendered a decision on the partial motion to dismiss. 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 “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. 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 LOI expired on October 25, 2025.
Contingent Liability for Legal Proceedings
FiberCel Litigation
Since August 2022, the Company has engaged in a process to negotiate and attempt to resolve many of the cases in the FiberCel Litigation. In total, Elutia’s liability in 64 of the cases has been settled for a total cash outlay of $ 22.5 million, with $ 9.6 million of such total settlement outlays having been paid through insurance proceeds. For the remaining 44 cases (which excludes one case that has been dismissed and one case where the statute of limitations has elapsed), the Company estimated a probable loss related to each case and has recorded a liability at a total estimated amount of $ 12.7 million at September 30, 2025, which is recorded within Contingent Liability for Legal Proceedings in the accompanying
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condensed consolidated balance sheets. Such liability includes $ 12.0 million for the 38 cases in which the settlements have been reached but had not yet been paid by quarter-end and $ 0.7 million for the six cases which have not yet been settled or adjudicated.
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 2024, the Company has also engaged in a process to negotiate and attempt to resolve many of the cases in the VBM Litigation. In total, Elutia’s liability in 13 of the cases has been settled for a total cash outlay of approximately $ 1.5 million. For the remaining 21 cases (which includes unasserted claims that the Company believes are probable of assertion and excludes one case that has been dismissed and one case where the statute of limitations has elapsed), the Company estimated a probable loss at an estimated amount of $ 3.7 million at September 30, 2025, which is recorded within Contingent Liability for Legal Proceedings in the accompanying consolidated balance sheets. 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 condensed consolidated statements of operations as incurred, with the entirety of such expense related to the VBM Litigation offset by the insurance 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 Legal Proceedings, the Company calculates amounts due to be reimbursed pursuant to the terms of the coverage and related agreements, and pursuant to other indemnity or contribution claims, in respect of product liability losses and related defense costs. The amounts probable of reimbursement or recovery from this calculation are recorded as receivables. The determination that the recorded receivables are probable of collection is based on the terms of agreements reached in respect of indemnity and contribution claims as well as the advice of the Company’s outside legal counsel. These receivables as of September 30, 2025 totaled $ 4.6 million and are recorded as Insurance Receivables of Litigation Costs in the accompanying consolidated balance sheets.
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As of September 30, 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 September 30, 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, Medtronic matter and Tiger matter.
Note 11. Net Income (Loss) Per Share
Three Months Ended
Nine Months Ended
(in thousands, except share and per share data)
September 30,
September 30,
2025
2024
2025
2024
Numerator:
Net income (loss) from continuing operations
$
( 383 )
$
3,339
$
( 9,361 )
$
( 38,190 )
Less: Undistributed net income to participating securities
—
( 219 )
—
—
Net income (loss) from continuing operations attributable to common stockholders
( 383 )
3,120
( 9,361 )
( 38,190 )
Loss attributable to common stockholders from discontinued operations
( 3,485 )
( 2,053 )
( 8,050 )
( 6,698 )
Net income (loss) attributable to common stockholders
( 3,868 )
1,067
( 17,411 )
( 44,888 )
Less: dilutive gain on revaluation of warrant liability, net of addback for undistributed net income to participating securities
( 5,098 )
( 12,822 )
( 12,518 )
—
Net loss attributable to common stockholders for diluted earnings per share
$
( 8,966 )
$
( 11,755 )
$
( 29,929 )
$
( 44,888 )
Denominator:
Weighted average number of common shares - basic
42,431,314
32,520,134
40,965,925
27,132,216
Effect of dilutive common and prefunded warrants
4,525,885
3,000,804
4,526,346
—
Weighted average number of common shares - diluted
46,957,199
35,520,938
45,492,271
27,132,216
Net income (loss) attributable to common stockholders from continuing operations per share - basic
$
( 0.01 )
$
0.10
$
( 0.23 )
$
( 1.41 )
Net loss per share attributable to common stockholders from continuing operations per share - diluted
$
( 0.12 )
$
( 0.27 )
$
( 0.48 )
$
( 1.41 )
Net income (loss) attributable to common stockholders from discontinued operations per share - basic
$
( 0.08 )
$
( 0.06 )
$
( 0.20 )
$
( 0.25 )
Net income (loss) attributable to common stockholders from discontinued operations per share - diluted
$
( 0.07 )
$
( 0.06 )
$
( 0.18 )
( 0.25 )
Net income (loss) attributable to common stockholders per share - basic
$
( 0.09 )
$
0.03
$
( 0.43 )
$
( 1.65 )
Net loss attributable to common stockholders per share - diluted
$
( 0.19 )
$
( 0.33 )
$
( 0.66 )
$
( 1.65 )
Basic net loss per share is computed by dividing net loss for the period by the weighted average number of common shares outstanding during the period.
Diluted net loss per share is computed by dividing the net loss, adjusted for gains on the revaluation of warrant liability (see Note 9), by the weighted average number of common shares outstanding for the period, adjusted for the dilutive effect of shares of common stock equivalents resulting from the exercise of the Common Warrants, 2023
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Prefunded Warrants, 2024 Prefunded Warrants and 2025 Prefunded Warrants. The treasury stock method was used to calculate the potential dilutive effect of these common stock equivalents.
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
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Options to purchase common stock
3,531,769
3,230,454
3,531,769
3,230,454
Restricted stock units
851,356
1,540,624
851,356
1,540,624
Class A common stock warrants
187,969
187,969
187,969
187,969
2023 Prefunded Warrants
—
3,896,130
—
4,137,718
2024 Prefunded Warrants
—
—
—
725,000
2025 Prefunded Warrants
—
—
—
—
Total
4,571,094
8,855,177
4,571,094
9,821,765
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 September 30, 2025, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
2,379
$
944
$
3,323
Cost of goods sold, excluding intangible asset amortization
1,024
177
1,201
Segment gross profit
$
1,355
$
767
$
2,122
For the nine months ended September 30, 2025, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
7,015
$
2,007
$
9,022
Cost of goods sold, excluding intangible asset amortization
3,091
442
3,533
Segment gross profit
$
3,924
$
1,565
$
5,489
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For the three months ended September 30, 2024, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
3,100
$
562
$
3,662
Cost of goods sold, excluding intangible asset amortization
1,361
240
1,601
Segment gross profit
$
1,739
$
322
$
2,061
For the nine months ended September 30, 2024, the Company’s segment gross profit was comprised of the following (in thousands):
Women's Health
Cardiovascular
Total
Net sales
$
9,238
$
2,413
$
11,651
Cost of goods sold, excluding intangible asset amortization
4,522
928
5,450
Segment gross profit
$
4,716
$
1,485
$
6,201
One customer in the Women’s Health segment, Tiger, represented 16 %, 26 %, 21 % and 24 % of total sales for the three months ended September 30, 2025 and 2024 and the nine months ended September 30, 2025 and 2024, respectively. The distribution agreement with Tiger was terminated by the Company effective in October 2025. Additionally, another customer in the Women’s Health segment represented 13 %, 9 %, 9 % and 5 % of total sales for the three months ended September 30, 2025 and 2024 and the nine months ended September 30, 2025 and 2024, respectively. One customer in the Cardiovascular segment, LeMaitre Vascular, represented 0 %, 13 %, 4 % and 16 % of total sales for the three months ended September 30, 2025 and 2024 and the nine months ended September 30, 2025 and 2024, respectively. The distribution agreement with LeMaitre Vascular was terminated by the Company in April 2025.
The following table is a reconciliation of segment gross profit to the consolidated loss before provision for income taxes for the three and nine months ended September 30, 2025 and 2024, (in thousands):
Three Months Ended
Nine Months Ended
September 30,
September 30,
2025
2024
2025
2024
Segment gross profit
$
2,122
$
2,061
$
5,489
$
6,201
Adjustments:
Intangible asset amortization expense
( 269 )
( 270 )
( 807 )
( 808 )
Sales and marketing
( 1,601 )
( 1,241 )
( 3,863 )
( 3,791 )
General and administrative
( 3,519 )
( 4,340 )
( 10,792 )
( 13,828 )
Research and development
( 1,088 )
( 702 )
( 2,948 )
( 2,271 )
Litigation costs, net
( 853 )
( 4,683 )
( 7,429 )
( 8,757 )
Loss from operations
( 5,208 )
( 9,175 )
( 20,350 )
( 23,254 )
Interest expense, net
265
131
( 42 )
796
(Gain) loss on revaluation of warrant liability
( 5,098 )
( 12,653 )
( 12,518 )
15,321
Other expense (income), net
—
—
1,547
( 1,186 )
Loss before provision for income taxes
$
( 375 )
$
3,347
$
( 9,337 )
$
( 38,185 )
During the nine months ended September 30, 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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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.