What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-05-15 compared with 2025-11-12 · 112 added, 261 removed, 158 unchanged (70% of the section changed)

7 unchanged sentences

At Elutia, our mission is to humanize medicine so that patients can thrive without compromise.

As a commercial-stage company, we seek to leverage our 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.

These complications include infection, device migration, erosion, implant rejection, non-union of implants, fibrosis and scar formation.

As more fully described below, on October 1, 2025, we sold substantially all of the assets that are related to our business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing our cardiac implantable electronic device (“CIED”) products, including CanGaroo® and EluPro™, to Boston Scientific Corporation (“BSC”) and Cardiac Pacemakers Inc (“CPI) for an aggregate purchase price of up to $88 million in cash.

EluPro is a unique bioenvelope designed to mitigate cardiac implantable electronic device complications including, device migration, erosion and bacterial colonization that can lead to infection.

The bioenvelope features a biomatrix comprised of extracellular matrix, which supports healthy wound healing and may facilitate re-operative procedures by reducing scar formation and fibrosis.

Additionally, EluPro is embedded with the powerful antibiotics rifampin and minocycline, which are gradually released over several weeks post-implantation to provide antimicrobial protection.

The CanGaroo bioenvelope, our first generation bioenvelope product, utilizes the same biomatrix but does not contain antibiotics.

In connection with the sale to BSC and CPI, we entered into a transition services agreement pursuant to which we will provide certain paid post-closing transitional support services in connection with the transfer of the CIED Business.

We also entered into a non-competition agreement with respect to the CIED Business for five years and a transition services agreement pursuant to which we agreed to provide certain paid post-closing transitional support services to BSC and CPI in connection with the transfer of the CIED Business (generally for periods of 12 to 30 months).

Following the divestiture, Elutia continues to market and sell its biologic products, including SimpliDerm, a human-derived acellular dermal matrix used in soft tissue reconstruction, and its cardiovascular (“CV”) portfolio, which comprises ProxiCor, VasCure, and Tyke.

SimpliDerm is currently the key component of our Women’s Health segment, and the CV portfolio represents the commercial offerings of our Cardiovascular segment.

These products form our established commercial foundation and provide a revenue base that supports ongoing investment in next-generation innovation.

We are now focused on advancing our proprietary drug-eluting biomatrix (“DEB”) platform for use in surgical reconstruction and related applications.

This platform combines our expertise in biologics and localized drug delivery to address complications that lead to poor outcomes in reconstructive procedures.

Our first commercial product under this platform, EluPro, demonstrated the clinical potential of combining a biologic scaffold with antibiotic drug delivery to reduce device-related complications.

We believe the same foundational technology can be applied to broader reconstructive and soft tissue repair markets where biologic matrix products are widely used but where outcomes remain suboptimal due to causes of failure, such as infection, inflammation, and fibrosis.

Despite the broad use of biologic matrices, innovation in these fields has been limited over the past two decades.

Few meaningful product improvements have emerged, and clinical outcomes have been compromised by persistently high

complication rates.

Traditional biologic matrices provide only passive structural support and do not actively promote healing.

By incorporating therapeutic agents, our DEB products are designed to overcome these limitations by improving the biologic environment around implants, reducing the foreign body response, and lowering postoperative complication rates.

The clinical and economic need in these markets is substantial, reflecting both the volume of reconstructive surgery and the persistence of high complication rates.

For example, in implant-based breast reconstruction and complex abdominal wall repair, infection rates can exceed 15% to 20%, leading to frequent reoperations and hospital readmissions.

We develop proprietary drug-eluting biomatrix products for use in surgical reconstruction and related applications.

These products are designed to improve the interaction between implanted medical devices and patients.

Our focus is on addressing unmet medical needs and reducing complications associated with surgery, including infection, migration, erosion, implant rejection, and fibrosis.

Our operations span research and development through the commercial distribution of biologic matrix products used in plastic and reconstructive surgery.

We have applied these capabilities to develop and commercialize products for specific surgical applications.

As more fully described below, on October 1, 2025, we divested one such product family through the sale of substantially all of the assets related to our business of developing, commercializing, manufacturing, selling and marketing our cardiac implantable electronic device (“CIED”) products, EluPro™ and CanGaroo®, to Boston Scientific Corporation (“BSC”) and Cardiac Pacemakers Inc (“CPI”) for an aggregate purchase price of up to $88.0 million in cash.

EluPro was the first antibiotic-eluting biologic matrix envelope for use with CIEDs.

This transaction reflects the technical and commercial value of solutions developed using our biologic matrices and local drug delivery capabilities.

Following the sale of the CIED business, we are focused on advancing our drug-eluting biomatrix (“DEB”) platform.

This platform builds on our biologic matrix and local drug delivery capabilities to address complications that lead to poor outcomes in reconstructive procedures and surgical repair.

EluPro demonstrated the commercial potential of combining a biologic scaffold with antibiotic drug delivery to reduce device-related complications.

We believe the same foundational technology can be applied to reconstructive and soft tissue repair markets where biologic matrix products are widely used, but where outcomes remain suboptimal due to complications such as infection, inflammation, and fibrosis.

The clinical and economic need in the reconstructive and soft tissue repair markets is substantial, reflecting both the volume of reconstructive surgery and the persistence of high complication rates.

For example, in implant-based breast reconstruction and complex abdominal wall repair, infection rates approximate 15% to 20%, leading to frequent reoperations and hospital readmissions.

Each year, in the United States, there are approximately 163,000 post-mastectomy breast reconstruction procedures, and roughly one in three experiences a serious complication such as infection, capsular contracture, or implant loss.

Biologic matrices represent an estimated $1.5 billion U.S.

market and account for more than 60% of reconstruction spending, yet meaningful innovation has been limited and unmet medical need remains.

Our lead development programs, NXT-41 and NXT-41x, are designed as next-generation biologic scaffolds combined with local antibiotic delivery.

NXT-41 features a porcine-derived engineered matrix that provides superior handling, consistency, and incorporation compared to human-derived acellular dermal matrices.

In NXT-41x, drug is incorporated into the matrix, and rifampin and minocycline are released locally over extended periods, offering broad-spectrum antimicrobial protection against the pathogens most associated with implant infections, without systemic toxicity.

The objective is to materially reduce complications arising from contamination, biofilm formation, and inflammation while maintaining surgeon-preferred handling, flexibility, and soft-tissue reinforcement for implant support.

We believe Elutia is well-positioned to pioneer a new class of active, performance-enhancing biomatrices for reconstructive biosurgery, combining biologic innovation and localized pharmacologic activity to improve outcomes for patients at favorable economics for healthcare systems.

In Women’s Health, we continue to advance our patented and proprietary technologies, building on extensive experience in regenerative materials.

We developed and launched SimpliDerm, a human acellular dermal matrix (hADM), designed for superior structural integrity, handling, and consistency that leverages the body’s natural healing processes.

Its proprietary processing methods help preserve key biologic components and reduce immunogenicity, which may mitigate inflammation and enhance tissue incorporation, leading to improved healing compared with other human ADM products.

SimpliDerm complements our NXT-41 and NXT-41x pipeline programs within the reconstructive biosurgery portfolio.

These products address overlapping call points with reconstructive and plastic surgeons, who consider biologic matrices essential tools in surgical reconstruction.

SimpliDerm establishes and strengthens the commercial channel for NXT-41 and NXT-41x, while building relationships, surgeon experience, and organizational capabilities to support the introduction of our next-generation biologic and drug-eluting technologies.

We sell SimpliDerm through independent sales agents to plastic and reconstructive surgeons.

To expand our distribution, in March 2023, we entered into a non-exclusive distribution agreement with Sientra, a medical aesthetics company focused on plastic surgery.

Subsequently, in April 2024, Tiger Aesthetics Medical (“Tiger”) assumed this agreement in connection with their acquisition of Sientra.

The agreement with Tiger was terminated by Elutia effective in October 2025.

We are now evaluating future commercial strategies to strengthen the Women’s Health channel and reassessing distribution approaches with the goal of achieving better alignment with reconstructive market priorities, including SimpliDerm, NXT-41, and NXT-41x.

SimpliDerm was historically processed at our Richmond, California facility, which was included in the divestiture of the Orthobiologics Business.

SimpliDerm is now supplied to Elutia through a long-term supply agreement with Berkeley Biologics, LLC (“Berkeley”).

In Cardiovascular, we market a portfolio of specialized porcine extracellular matrix products, including ProxiCor and VasCure, used for intracardiac and vascular repair as well as for pericardial reconstruction.

Our TYKE product is specifically designed for use in the neonatal patient population.

From May 2017 through March 2023, these products were sold directly to hospitals and other healthcare facilities through our sales force and independent sales agents.

In April 2023, we entered into an exclusive distribution agreement with LeMaitre Vascular for these products in the United States.

The agreement was terminated on April 30, 2025, and we resumed selling these products directly to hospitals and other healthcare facilities through independent sales agents.

Our supply chain strategy is designed to ensure the quality and continuity of our cardiovascular product manufacturing and distribution.

We rely on a single or limited number of suppliers for certain raw materials and supplies.

We have a long-term supply agreement with Cook Biotech, now owned by Evergen, the supplier of our porcine extracellular matrix for our cardiovascular products.

We historically performed the minor finished goods conversion activities along with the stocking and distribution of the cardiovascular products at our manufacturing facility in Roswell, Georgia.

Our Roswell facility was acquired by BSC in connection with the sale of the CIED Business, and these logistics are now provided to us through a third-party logistics provider, ensuring uninterrupted supply.

In March 2025, we signed a lease for 26,598 square feet of production, laboratory and administrative space in Gaithersburg, Maryland and moved our executive offices to that location in May 2025.

We are currently using this space for administrative purposes along with development of NXT-41 and NXT-41x and anticipate using this facility for the commercial production of these products, to the extent marketing authorization is obtained.

We believe biologic matrices represent an estimated $1.5 billion U.S.

market opportunity and account for more than 60% of reconstruction spending, yet meaningful innovation has been limited and significant unmet medical need remains.

Our lead development programs comprise NXT-41, a next-generation biologic matrix, and NXT-41x, which builds on the NXT-41 matrix by incorporating local antibiotic delivery.

NXT-41 is an advanced biomatrix designed to provide consistent handling and incorporation while enabling scalable manufacturing.

In NXT-41x, antibiotics are incorporated into the matrix and released locally over extended periods, offering broad-spectrum antimicrobial protection against common causes of post-surgical infection.

Elutia continues to market and sell its proprietary biologic matrix products, including SimpliDerm®, a human acellular dermal matrix (“hADM”) used in soft tissue reconstruction, and its cardiovascular repair portfolio, comprising

ProxiCor, VasCure, and Tyke.

SimpliDerm is the primary commercial product in our Women’s Health segment, and the cardiovascular products reside in our Cardiovascular segment.

These products are sold directly to healthcare facilities through independent sales agents.

SimpliDerm was historically processed at our former Richmond, California facility, which was included in the divestiture of the Orthobiologics Business in 2023.

SimpliDerm is now supplied to Elutia through a long-term supply agreement with Berkeley, the acquiror of our Orthobiologics Business.

The porcine SIS-ECM for our Cardiovascular products is supplied by Cook Biotech Incorporated (“Cook”), now owned by Evergen, through a long-term supply agreement.

Both Berkeley and Cook are currently our sole sources of supply within the respective product offerings, and we cannot guarantee that an interruption in supply will not occur.

In March 2025, we signed a lease for 26,598 square feet of production, laboratory and administrative space in Gaithersburg, Maryland, which now serves as our headquarters and primary operations site.

This facility supports administrative functions as well as the development of NXT-41 and NXT-41x and, subject to obtaining the necessary FDA marketing authorizations, is expected to support the commercial production of NXT-41x, to the extent marketing authorization is obtained.

Discontinued Operations - Sale of CIED Businesses

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 Elutia substantially all of the assets that are related to our 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”).

Prior to the divestiture, we sold EluPro and CanGaroo in the United States using our direct sales force and our commercial partner, BSC, which acted as a sales agent and gave us access to approximately 900 sales representatives and clinical specialists to further expand our footprint and accelerate our sales.

Our primary customers were electrophysiologists and neurosurgeons.

Our direct sales force was focused on gaining additional market access and driving market penetration, not only by selling our products, but also, where appropriate, by managing our commercial partners and providing technical assistance for selling our products.

Our sales team provided the critical knowledge of the advantages that EluPro and CanGaroo provide for patients over those of our competitors.

We shipped the product directly to hospitals.

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, with $80.3 million (which included a preliminary inventory adjustment of $0.3 million) that was paid in cash to Elutia at closing of the transactions and $8 million that was deposited at the closing of the transactions in escrow for a period of twelve months, which is subject to potential reduction in the event of certain post-closing breaches of representations and warranties within the APA by Elutia.

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.

As described in Note 2 to the condensed consolidated financial statements, the sale of the CIED Business is accounted for as Discontinued Operations for all periods presented in accordance with Accounting Standards Codification (“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.

On September 8, 2025, we executed an Asset Purchase Agreement (the “APA”) with Boston Scientific Corporation (“BSC”) and Cardiac Pacemakers Inc.

(collectively with BSC, the “CIED Buyers”).

On October 1, 2025, at the closing of the transactions contemplated by the APA, the CIED Buyers purchased from Elutia substantially all of the assets related to its business of researching, developing, administering, operating, commercializing, manufacturing, selling and marketing CIED products, including the CanGaroo®, CanGaroo® RM, EluPro™ and CIED envelope products, including next generation CIED envelope products (collectively the “CIED Business”).

The APA provided for an aggregate purchase price, subject to certain adjustments pursuant to the terms of the APA, of up to $88 million in cash, with $80.4 million (which included an inventory adjustment of $0.4 million) that was paid in cash to Elutia at closing of the transactions, and $8.0 million that was deposited at the closing of the transactions in escrow for a period of twelve months, which is subject to potential reduction in the event of certain post-closing breaches of representations and warranties within the APA by Elutia.

The assets of the CIED Business constituted substantially all of the assets previously held in Elutia’s Device Protection segment.

The CIED Buyers only assumed certain liabilities related to performance of the contracts transferred in the APA.

As described in Note 2 to the consolidated financial statements, the sale of the CIED Business was accounted for as Discontinued Operations for all periods presented in accordance with Accounting Standards Codification (“ASC”) 205-20, Discontinued Operations .

Consequently, the results of operations from the CIED Business are reported as discontinued operations in the consolidated statements of operations for the three months ended March 31, 2025.

Prior to the divestiture, we marketed EluPro and CanGaroo in the United States through our direct sales force, supported by a commercial partner, BSC.

As part of the divestiture, the sales organization supporting the CIED business transferred to the CIED Buyers.

Payoff and Termination of SWK Loan Facility

On October 1, 2025, in connection with and through the proceeds of the sale of the Company’s CIED Business described in Note 2 to the condensed consolidated financial statements, we fully repaid the SWK Loan Facility as required by the terms of the credit agreement.

As of such date, the outstanding principal, including the accrued exit fee, and accrued

interest totaled approximately $26.5 million.

On October 1, 2025, in connection with and through the proceeds of the sale of the Company’s CIED Business described in Note 2 to the consolidated financial statements, we fully repaid the SWK Loan Facility as required by the terms of the credit agreement.

As of such date, the outstanding principal, including the accrued exit fee, and accrued interest totaled approximately $26.9 million.

The total payment by the Company to SWK in full satisfaction of the debt and termination of the credit agreement was $27.8 million.

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The Orthobiologics Business was comprised of assets relating to researching, developing, administering, insuring, operating, commercializing, manufacturing, selling and marketing our 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 our Orthobiologics segment.

In the sale, we received $14.6 million, and we may earn up to an additional $20 million, in the aggregate, in the form of earn-out payments.

The assets sold represented the entirety of our Orthobiologics segment.

We received approximately $14.6 million, and we may earn up to an additional $20.0 million, in the aggregate, in the form of earn-out payments.

The earn-out payments are equal to 10% of the actual revenue earned by Berkeley in each of the five years after the closing of the sale from sales of specified Orthobiologics products under the purchase agreement (including improvements, modifications, derivatives and enhancements related to those products).

There have been no earn-out payments made to date.

Additionally, the purchase agreement provides for a customary indemnity holdback in the amount of $1.5 million to be retained by Berkeley for 24 months after closing.

In the purchase agreement, the Company has retained the liabilities arising out of the viable bone matrix (“VBM”) and FiberCel matters, as described in Note 10, both of which products were part of the Orthobiologics Business.

Pursuant to the purchase agreement, we retained the liabilities arising out of the viable bone matrix (“VBM”) and FiberCel recall matters, as described in Note 17 to the consolidated financial statements, both of which products were part of the Orthobiologics Business.

We recognized a gain of $6.0 million on the sale of the Orthobiologics Business in 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.

Should we 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.

Product Recalls

In June 2021, we issued a voluntary recall pertaining to a single donor lot of our FiberCel Fiber Viable Bone Matrix, a bone repair product formerly manufactured under a contract with Medtronic PLC, which also distributed the product.

The recall was issued after learning of postsurgical infections reported in several patients treated with the product, including some patients that tested positive for tuberculosis.

Additionally, i n July 2023, we announced a voluntary recall of a single lot of one of our viable bone matrix (“VBM”) products and the market withdrawal of all of our VBM products produced after a specified date.

Notice of the voluntary recall was issued to centers after we learned of post-surgical tuberculosis infections in two patients treated with product from a single donor lot of our VBM product.

Both of these products were part of our Orthobiologics Business, which we have fully divested as described above.

For information about legal proceedings in which we are involved and the possible future financial implications, see Note 9 to the condensed consolidated financial statements included elsewhere in this Quarterly Report.

Additionally, the purchase agreement provided for a customary indemnity holdback in the amount of $1.5 million to be retained by Berkeley for 24 months after closing of the transaction.

In March 2026, the indemnity holdback was resolved with Berkeley remitting $0.4 million to Elutia.

Such amount was recognized as additional gain in the first quarter of 2026.

Should we receive incremental proceeds in the future through an earn-out payment, an additional gain will be recorded upon the receipt of such amounts.

Components of Our Results of Operations

We recognize revenue on the sale of our products.

We recognize revenue from the sale of our products.

Our Women’s Health products are sold directly to hospitals and other healthcare facilities through independent sales agents, and until its termination in October 2025, through our distribution agreement with Tiger.

From April 2023 through April 2025, our Cardiovascular products were sold through a distribution agreement with LeMaitre Vascular.

In April 2025, this agreement with LeMaitre Vascular terminated, and, in May 2025, we began selling these products directly to hospitals and other healthcare facilities through independent sales agents.

In April 2025, this agreement with LeMaitre Vascular terminated, and, in May 2025, we resumed selling these products directly to hospitals and other healthcare facilities through independent sales agents.

In recent years, we have incurred significant costs in the operation of our business.

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We may, however, still experience more significant expense increases to the extent we expand our sales and marketing, product development and clinical and research activities.

As a result, we will need to generate significant net

sales in order to achieve profitability.

As a result, we will need to generate significant net sales in order to achieve profitability.

Below is a breakdown of our main expense categories and the related expenses incurred in each category:

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General and Administrative Expenses

General and administrative (“G&A”) expenses consist primarily of compensation, consulting, legal, human resources, information technology, accounting, insurance and general business expenses.

Our G&A expenses have increased as a result of operating as a public company, in particular as a result of hiring additional personnel and incurring greater director and officer insurance premiums, greater investor relations costs, and additional costs associated with accounting, legal, tax-related and other services associated with maintaining compliance with exchange listing and SEC requirements.

General and administrative (“G&A”) expenses consist primarily of compensation, consulting, legal, human resources, information technology, accounting, insurance (including directors and officer premiums), SEC compliance, and general business expenses.

Research and Development Expenses

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Over the last several years, our product development efforts have primarily related to activities associated with the development of EluPro, our initial DEB product offering, which gained FDA clearance in June 2024 and was sold in connection with the divestiture of the CIED Business in October 2025.

Future development efforts and associated internal and external costs are expected to focus on our lead development programs, NXT-41 and NXT-41x, which are designed as next-generation biologic scaffolds combined with local antibiotic delivery.

Future development efforts and associated internal and external costs are expected to focus on our lead development programs consisting of next-generation biologic scaffolds combined with local antibiotic delivery.

Litigation Costs, net

Litigation costs, net consist primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the estimated and actual amounts recoverable or recovered under insurance, indemnity and contribution agreements for such costs.

Such expenses also include the FiberCel-related Medtronic litigation.

See Note 10 to the condensed consolidated financial statements for further discussion of all litigation proceedings.

Results of Operations

Comparison of the Three Months Ended September 30, 2025 and 2024

Three Months Ended September 30,

Change 2024 / 2025

(in thousands, except percentages)

Cost of goods sold

Sales and marketing

General and administrative

Research and development

Litigation costs, net

Total operating expenses

Loss from operations

Interest expense, net

Gain on revaluation of warrant liability

Other expense (income), net

Loss before provision for income taxes

Income tax expense

Net income (loss) from continuing operations

Loss from discontinued operations

Net income (loss)

NM = not meaningful

Net sales information for our products is summarized as follows:

Three Months Ended September 30,

Change 2024 / 2025

(in thousands, except percentages)

Women's Health

Cardiovascular

Total Net Sales

Total net sales were $3.3 million in the three months ended September 30, 2025, a decrease of $0.4 million compared to $3.7 million in the three months ended September 30, 2024.

The decrease was due to Women’s Health where the sales of SimpliDerm generated by Tiger totaled $0.5 million in the three months ended September 30, 2025, a decline of $0.4 million from the prior year three-month period.

As noted above, we terminated the distribution agreement with Tiger effective in October 2025.

Cost of Goods Sold

Cost of goods sold and gross margin percentage information for our products is summarized as follows:

Three Months Ended September 30,

Change 2024 / 2025

(in thousands, except percentages)

Women's Health

Cardiovascular

Cost of goods sold, excluding intangible asset amortization

Intangible asset amortization expense

Total Cost of Goods Sold

Total cost of goods sold decreased $0.4 million to $1.5 million in the three months ended September 30, 2025 compared to $1.9 million in the three months ended September 30, 2024.

Gross margin was 55.8% in the three months ended September 30, 2025 compared to 48.9% in the three months ended September 30, 2024.

Gross margin, excluding intangible asset amortization, was 63.9% in the three months ended September 30, 2025 compared to 56.3% in the three months ended September 30, 2024.

The improvement between years was due primarily to Cardiovascular, where we terminated our exclusive distribution agreement with LeMaitre Vascular on April 30, 2025, upon which we resumed selling these products directly to hospitals and other healthcare facilities through independent sales agents with end user pricing.

Operating Expenses

Sales and Marketing

Sales and marketing expenses increased $0.4 million, or 29.0%, to $1.6 million in the three months ended September 30, 2025 compared to $1.2 million in the three months ended September 30, 2024.

As a percentage of sales, sales and marketing expenses increased to 48.2% in the three months ended September 30, 2025 from 33.9% in the three months ended September 30, 2024.

The increase was largely attributable to sales commission expense growth commensurate with the resumption in the second quarter of 2025 of the direct selling of our Cardiovascular products as well as higher percentage of SimpliDerm sales occurring through our commissioned independent sales representatives in 2025.

General and Administrative

G&A expenses decreased $0.8 million, or 18.9%, to $3.5 million in the three months ended September 30, 2025 compared to $4.3 million in the three months ended September 30, 2024.

The decrease in expense was primarily driven by lower non-cash equity compensation in the 2025 period.

Research and Development

R&D expenses increased $0.4 million, or 55.0% to $1.1 million in the three months ended September 30, 2025 compared to $0.7 million in the three months ended September 30, 2024.

The increase in expense reflects our heightened development activity in the 2025 period as we aggressively pursue the development of NXT-41 and NXT-41x, our next-generation biologic scaffolds combined with local antibiotic delivery.

Litigation Costs, net

Litigation costs, net decreased to $0.9 million in the three months ended September 30, 2025 compared to $4.7 million in the three months ended September 30, 2024.

The decrease in expense was primarily due to significant reductions

in our FiberCel activities and related contingent liability fluctuations with nearly all cases having been settled as of September 30, 2025.

As of September 30, 2025, insurance remains available to cover the cost of the VBM Litigation and related defense costs;

however, we have no more insurance to cover the cost of the FiberCel Litigation and the related defense costs.

See further discussion in Note 9 to the condensed consolidated financial statements.

Interest Expense, net

Interest expense, net was approximately $0.3 million in the three months ended September 30, 2025 compared to $0.1 million in the three months ended September 30, 2024.

With our sale of the CIED Business and the required repayment of our SWK debt upon close, all interest expense related to our SWK Loan Facility (see Note 7 to the condensed consolidated financial statements) has been included within Loss from Discontinued Operations for all periods presented.

The remaining interest expense relates to our Amended Revenue Interest Obligation (see Note 8 to the condensed consolidated financial statements) and the financing of certain insurance premiums.

The increase between periods was due to higher interest income (offset to interest expense) in the 2024 period due to larger amounts of cash on hand.

Discontinued Operations

Loss from discontinued operations was $3.5 million and $2.1 million for the three months ended September 30, 2025 and 2024, respectively.

The increase between years was due to higher sales and marketing costs in the 2025 period which offset the growth in CIED sales and gross profit in the current year.

Also contributing to the increase were legal fees totaling approximately $0.9 million recognized in the three months ended September 30, 2025 which were incurred in connection with the CIED Business divestiture in October 2025.

Comparison of the Nine months Ended September 30, 2025 and 2024

Nine Months Ended September 30,

Comparison of the Three Months Ended March 31, 2026 and 2025

Three Months Ended March 31,

Change 2025 / 2026

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Total operating expenses

Loss from operations

Interest expense, net

(Gain) loss on revaluation of warrant liability

Other expense (income), net

Loss before provision of income taxes

Loss from continuing operations

Interest (income) expense, net

Loss (gain) on revaluation of warrant liability

Other (income) expense, net

Loss from continuing operations before provision for income taxes

Income tax expense

Net loss from continuing operations

Loss from discontinued operations

Income (loss) from discontinued operations

Net income (loss)

NM = not meaningful

Net sales information for our products is summarized as follows:

Nine Months Ended September 30,

Three Months Ended March 31,

Change 2025 / 2026

3 unchanged sentences

Total Net Sales

Total net sales decreased $2.6 million, or 22.6%, to $9.0 million in the nine months ended September 30, 2025 compared to $11.7 million in the nine months ended September 30, 2024.

The decrease was due primarily to Women’s Health and caused, in large part, by various physician users of SimpliDerm who transferred to hospitals where SimpliDerm is not yet available.

Additionally, sales of SimpliDerm generated by Tiger totaled $1.9 million in the nine months ended September 30, 2025, a decrease of $0.9 million from the prior year nine-month period.

Total net sales were $3.1 million in the three months ended March 31, 2026, an increase of $0.2 million compared to $2.9 million in the three months ended March 31, 2025.

The increase was due to higher sales of Cardiovascular compared to the three months ended March 31, 2025, partially offset by declines in Women’s Health.

With respect to Cardiovascular, our former exclusive distribution agreement with LeMaitre Vascular terminated in April 2025, and we resumed selling these products directly through independent sales agents in May 2025.

The sales increases in the three months ended March 31, 2026 were generated by both volume growth and higher unit prices as such sales are now at end-user pricing versus contracted prices (which are lower than end-user pricing).

The decrease in Women’s Health was caused by our termination of the Tiger distribution agreement as noted above, partially offset by growth in sales by our independent sales agents.

Sales of SimpliDerm generated by Tiger totaled $0.9 million in the three months ended March 31, 2025.

Cost of Goods Sold

Cost of goods sold and gross margin percentage information for our products is summarized as follows:

Nine Months Ended September 30,

Three Months Ended March 31,

Change 2025 / 2026

5 unchanged sentences

Total Cost of Goods Sold

Total cost of goods sold decreased $1.9 million to $4.3 million in the nine months ended September 30, 2025 compared to $6.3 million in the nine months ended September 30, 2024.

Gross margin was 51.9% in the nine months ended September 30, 2025 compared to 46.3% in the nine months ended September 30, 2024.

Gross margin, excluding intangible asset amortization, was 60.8% in the nine months ended September 30, 2025 compared with 53.2% in the nine months ended September 30, 2024.

Total cost of goods sold decreased $0.3 million to $1.3 million in the three months ended March 31, 2026 compared to $1.6 million in the three months ended March 31, 2025.

Gross margin was 57.9% in the three months ended March 31, 2026 compared to 46.8% in the three months ended March 31, 2025.

Gross margin, excluding intangible asset amortization, was 66.5% in the three months ended March 31, 2026 compared to 55.9% in the three months ended March 31, 2025.

The improvement between years was due to both Women’s Health and Cardiovascular, where, in mid to late 2025, we resumed selling these products only directly to hospitals and other healthcare facilities through our independent sales agents where end user pricing (versus contracted prices with distributors) yields higher margins.

Operating Expenses

Sales and Marketing

Sales and marketing expenses increased $0.1 million, or 1.9%, to $3.9 million in the nine months ended September 30, 2025 compared to $3.8 million in the nine months ended September 30, 2024.

As a percentage of sales, sales and marketing expenses increased to 42.8% in the nine months ended September 30, 2025 from 32.5% in the nine months ended September 30, 2024.

The increase was largely attributable to sales commission expense growth commensurate with the resumption in the second quarter of 2025 of the direct selling of our Cardiovascular products.

Sales and marketing expenses increased $0.5 million, or 48.7%, to $1.5 million in the three months ended March 31, 2026 compared to $1.0 million in the three months ended March 31, 2025.

As a percentage of sales, sales and marketing expenses increased to 47.5% in the three months ended March 31, 2026 from 33.7% in the three months ended March 31, 2025.

The increase was largely attributable to sales commission expense growth commensurate with the resumption in the direct selling of our Cardiovascular products as well as the entirety of SimpliDerm sales occurring through our commissioned independent sales agents in 2026.

General and Administrative

G&A expenses decreased $3.0 million, or 22.0%, to $10.8 million in the nine months ended September 30, 2025 compared to $13.8 million in the nine months ended September 30, 2024.

The decrease in expense was primarily driven by lower non-cash equity compensation in the 2025 period.

G&A expenses increased $0.4 million, or 9.9%, to $4.1 million in the three months ended March 31, 2026 compared to $3.7 million in the three months ended March 31, 2025.

The increase in expense was primarily driven by the incremental facility costs associated with our Gaithersburg headquarters to which we moved in May 2025.

Research and Development

R&D expenses increased to $2.9 million in the nine months ended September 30, 2025 compared to $2.3 million in the nine months ended September 30, 2024.

R&D expenses increased $1.1 million, or 126.5% to $2.0 million in the three months ended March 31, 2026 compared to $0.9 million in the three months ended March 31, 2025.

The increase in expense reflects our heightened development activity in the 2026 period as we aggressively pursue the development of NXT-41 and NXT-41x, our next-generation biologic scaffolds combined with local antibiotic delivery.

Litigation Costs, net

FiberCel litigation costs decreased to $7.4 million in the nine months ended September 30, 2025 compared to $8.8 million in the nine months ended September 30, 2024.

The decrease in expense was primarily due to the continued evaluation of the contingent FiberCel liability and significant reductions in our FiberCel activities with nearly all cases having been settled as of September 30, 2025.

As of September 30, 2025, insurance remains available to cover the cost of the VBM Litigation and related defense costs;

Litigation costs, net decreased to $0.6 million in the three months ended March 31, 2026 compared to $2.6 million in the three months ended March 31, 2025.

The decrease in expense was primarily due to significant reductions in our FiberCel activities and related contingent liability fluctuations with nearly all cases having been settled as of March 31, 2026.

As of March 31, 2026, insurance remains available to cover the cost of the VBM Litigation and related defense costs;

however, we have no more insurance to cover the cost of the FiberCel Litigation and the related defense costs.

See further discussion in Note 10 to the condensed consolidated financial statements.

Interest Expense

Interest expense was less than $0.1 million in the nine months ended September 30, 2025 compared to $0.8 million in the nine months ended September 30, 2024.

The decrease was primarily due to the error correction related to the January 2024 Ligand amendment described in Note 7 to the condensed consolidated financial statements.

Discontinued Operations

Loss from discontinued operations was $8.0 million and $6.7 million for the nine months ended September 30, 2025 and 2024, respectively.

The increase was due to higher sales and marketing costs in the 2025 period which offset the growth in CIED sales and gross profit in the current year.

Also contributing to the increase were legal fees totaling approximately $0.9 million recognized in the nine months ended September 30, 2025 which were incurred in connection with the CIED Business divestiture in October 2025.

Interest (Income) Expense, net

Interest (income) expense, net was interest income of $0.1 million in the three months ended March 31, 2026 and interest expense of $0.2 million in the three months ended March 31, 2025.

The change results from a higher average cash balance in the 2026 period yielding greater interest income to offset the interest expense incurred on the Ligand Revenue Interest Obligation deseribed below.

Non-GAAP Financial Measures

This Quarterly Report presents our gross margin, excluding intangible asset amortization, for the three and nine months ended September 30, 2025 and 2024.

This Quarterly Report presents our gross margin, excluding intangible asset amortization, for the three months ended March 31, 2026 and 2025.

We calculate gross margin, excluding intangible asset amortization, as gross profit, excluding amortization expense relating to intangible assets we acquired in the CorMatrix Acquisition, divided by net sales.

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In addition, other companies, including companies in our industry, may use other measures to evaluate their performance, which could reduce the usefulness of this non-GAAP financial measure as a tool for comparison.

The following table presents a reconciliation of our gross margin, excluding intangible asset amortization, for the nine months ended September 30, 2025 and 2024, to the most directly comparable GAAP financial measure, which is our GAAP gross margin (in thousands).

The following table presents a reconciliation of our gross margin, excluding intangible asset amortization, for the three months ended March 31, 2026 and 2025, to the most directly comparable GAAP financial measure, which is our GAAP gross margin (in thousands).

Three Months Ended

Nine Months Ended

September 30,

Cost of goods sold

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Liquidity and Capital Resources

As of September 30, 2025, we had cash of approximately $4.7 million.

Additionally, on October 1, 2025, upon closing of the sale of our CIED Business, and the payment of transaction expenses and the required repayment of our SWK debt, we received cash proceeds of approximately $49 million.

As of March 31, 2026, we had cash and cash equivalents of approximately $28.5 million.

Since inception, we have financed our operations primarily through amounts borrowed under our credit facilities, proceeds from our initial public offering (“IPO”), sales of our products and more recently, the sale of our Orthobiologics and CIED Businesses and proceeds from follow-on offerings and private placements of our common stock and warrants.

Our 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 our production activities, litigation defense and settlement costs and investing in our commercial infrastructure.

Our historical cash outflows have primarily been associated with manufacturing and administrative costs, sales and marketing, research and development, clinical activity, purchase of property and equipment used in our production activities, litigation defense and settlement costs and investing in our commercial infrastructure.

We expect to incur operating losses and negative cash flows from operations for the foreseeable future as we advance our development and commercialization of NXT-41 and NXT-41x.

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The Common Units were sold at a purchase price of $1.4275 per unit, and the 2023 Prefunded Units were sold at a purchase price of $1.4265 per unit, for aggregate gross proceeds of approximately $10.5 million, before deducting offering expenses.

Each Common Warrant was exercisable until July 31, 2024, the date which was 30 trading days after the clearance by the FDA of the Company’s EluPro product, at an exercise price per share of $1.4275.

Each Common Warrant was exercisable until July 31, 2024, the date which was 30 trading days after the clearance by the FDA of EluPro, at an exercise price per share of $1.4275.

All Common Warrants were exercised by such date yielding exercise proceeds of $15.7 million in 2024.

Certain of these exercises ultimately resulted in their conversion to 2023 Prefunded Warrants.

Certain of these exercises ultimately

resulted in their conversion to 2023 Prefunded Warrants.

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 us).

Cash Flows for the Nine months ended September 30, 2025 and 2024

Nine Months Ended

September 30,

As of such date, the outstanding principal, including the accrued exit fee, and accrued interest totaled approximately $26.9 million.

The total payment by the Company to SWK in full satisfaction of the debt and termination of the credit agreement was $27.8 million.

Cash Flows for the Three Months ended March 31, 2026 and 2025

Three Months Ended

(in thousands)

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Cash Flows From Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2025 was $20.0 million compared to $10.4 million for the nine months ended September 30, 2024.

The increase was primarily due to inventory growth in the 2025 period to keep pace with EluPro sales growth, as well as FiberCel settlement payments of $8.1 million in the nine months ended September 30, 2025.

Net cash used in operating activities for the three months ended March 31, 2026 was $7.9 million compared to $8.9 million for the three months ended March 31, 2025.

The decrease was primarily due to a lower operating loss in the current year.

Cash Flows From Investing Activities

Net cash used in investing activities for the nine months ended September 30, 2025 was $1.0 million compared to $0.4 million for the nine months ended September 30, 2024.

The increase primarily reflects higher investments in our production facilities in 2025 as we continue the buildout of our new Gaithersburg location in preparation for the commercial production of NXT-41 and NXT-41x to the extent marketing authorization is obtained.

Net cash used in investing activities for the three months ended March 31, 2026 was less than $0.1 million compared to $0.3 million for the three months ended March 31, 2025.

The decrease was primarily due to proceeds received from the sale of our Orthobiologics Business during the first quarter of 2026.

Cash Flows From Financing Activities

Net cash provided by financing activities for the nine months ended September 30, 2025 was $12.5 million compared to $17.2 million for the nine months ended September 30, 2024.

The current year’s cash generation was primarily through the 2025 Registered Offering which yielded net proceeds of $13.8 million offset by financed insurance premium payments.

The prior year’s cash generation was primarily through the 2024 Registered Offering and warrant exercises, which yielded net proceeds of $28.1 million offset by long-term debt and the revenue interest obligation payments totaling $8.3 million.

Credit Facilities

Net cash provided by financing activities for the three months ended March 31, 2026 was less than $0.1 million compared to $13.3 million for the three months ended March 31, 2025.

The prior year’s cash generation was primarily through the 2025 Registered Offering.

Payoff and Termination of SWK Loan Facility

O n August 10, 2022 (the “Closing Date”), we entered into a senior secured term loan facility with SWK Funding LLC (“SWK”), as agent, and other lenders party thereto (as amended and modified subsequent to the Closing Date, the “SWK Loan Facility”) for an aggregate principal amount of $25 million.

An initial draw of $21 million was made on the Closing Date with the additional $4 million drawn on December 14, 2022.

As of September 30, 2025, we had $26.1 million of indebtedness outstanding under our SWK Loan Facility and an exit fee liability to SWK of $1.1 million, with such balances being net of $0.4 million of unamortized discount and deferred financing costs.

On August 15, 2025, we entered into a fifth amendment (the “Fifth Amendment”) to the credit agreement governing 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.

On October 1, 2025, in connection with and through the proceeds of the sale of the Company’s CIED Business described in Note 2 to the condensed consolidated financial statements, Elutia fully repaid the SWK Loan Facility as required by the terms of the credit agreement.

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The total payment by the Company to SWK in full satisfaction of the debt and termination of the credit agreement was $27.8 million.

Interest Rates

All of the SWK Loan Facility borrowings took the form of Secured Overnight Financing Rate (“SOFR”) loans and bear interest at a rate per annum equal to the sum of an applicable margin of (i) 7.75% and the “Term SOFR Rate” (based upon an interest period of 3 months), or (ii) if we had elected the PIK Interest option (as defined below), 3.75% and the “Term SOFR Rate.” We 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%.

Optional Prepayment

The agreement, as amended, 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.

Covenants and Other Matters

The SWK Loan Facility Agreement that governed the SWK Loan Facility contained a number of covenants that, among other things and subject to certain exceptions, restricted our ability to:

incur additional indebtedness;

incur certain liens;

pay dividends or make other distributions on equity interests;

redeem, repurchase or refinance subordinated indebtedness;

consolidate, merge or sell or otherwise dispose of assets;

make investments, loans, advances, guarantees and acquisitions;

enter into transactions with affiliates;

amend or modify our governing documents;

amend or modify certain material agreements;

and alter the business conducted by us and our subsidiaries.

In addition, the SWK Loan Facility

Agreement contained two financial covenants.

The first covenant, which was measured quarterly, required us to achieve a specified Minimum Aggregate Revenue (as defined in the SWK Loan Facility) for the preceding 12-month period or, alternatively, to maintain Consolidated Unencumbered Liquid Assets (as defined in the SWK Loan Facility) greater than either (i) the outstanding principal balance of the loan, or (ii) the aggregate operating cash burn (as defined in the SWK Loan Facility) for the preceding 12-month period.

The second covenant initially required us to maintain a minimum liquidity (as defined in the SWK Loan Facility) of the greater of (a) $5.0 million and (b) the sum of the operating cash burn for the two prior consecutive fiscal quarters then ended (the “Liquidity Covenant”).

In May 2025, we entered into an amendment to the SWK Loan Facility.

The amendment, among other things:

(i) allowed for 100% of the interest payment due and owing in May 2025 to be paid as PIK interest, (ii) removed mandatory repayment obligations related to non-ordinary course asset sales, (iii) allowed us to request that SWK advance a new term loan in the amount of up to $5.0 million, which advance will be in the sole and absolute discretion of SWK and (iv) fixed the amount of the Liquidity Covenant to a minimum liquidity of $8.0 million.

In consideration for the amendment, the Company agreed to issue SWK 50,000 shares of its Class A Common Stock in a private placement.

As of September 30, 2025, we were in compliance with the financial covenants, as amended, and all other covenants under the credit agreement governing the SWK Loan Facility.

Ligand Revenue Interest Obligation

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Funding Requirements

As of October 31, 2025, we had cash and cash equivalents of approximately $44 million.

This amount is the resulting balance from our cash on hand as of September 30, 2025, plus the cash proceeds from the sale of our CIED Business less transaction expenses, full repayment of our SWK debt, payments of $2.2 million on Ligand obligations, certain FiberCel settlements and other working capital requirements.

As of March 31, 2026, we had cash and cash equivalents of approximately $28.5 million.

We expect to continue to incur significant expenses and operating losses for the foreseeable future as we further expand our product development and clinical and research activities.

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However, such transactions may not be successful, and we may not be able to raise additional equity or debt, sell or license assets or obtain waivers or amendments on acceptable terms, or at all.

We may also consider raising additional capital in the future to expand our

business, pursue strategic investments or take advantage of financing opportunities.

We may also consider raising additional capital in the future to expand our business, pursue strategic investments or take advantage of financing opportunities.

Our present and future funding requirements will depend on many factors, including, among other things:

● the cost of our research and development activities and the cost and timing of commercializing new products or technologies;

● the costs of defending against, or the damages payable in connection with the FiberCel Litigation and VBM Litigation, associated litigation related to indemnity claims by other defendants to the FiberCel Litigation and any future litigation that we may be subject to (to the extent above the applicable insurance coverage);

● the cost of our research and development activities and the cost and timing of commercializing new products or technologies, including NXT-41 and NXT-41x;

● the costs of defending against, or the damages payable in connection with the FiberCel Litigation and VBM Litigation, associated litigation related to indemnity claims by other defendants to the FiberCel Litigation and any other ongoing or future litigation that we are or may be subject to (to the extent above the applicable insurance coverage);

● continued patient, physician and market acceptance of our products;

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The preparation of our unaudited condensed consolidated financial statements in accordance with GAAP requires us to make estimates and assumptions that affect reported amounts and related disclosures.

We have discussed the policies and estimates that we believe are critical and require the use of complex judgment in their application in our Annual Report, and, during the nine months ended September 30, 2025, there were no material changes to those previously disclosed other than those outlined in Note 2, “Summary of Significant Accounting Policies.”

We have discussed the policies and estimates that we believe are critical and require the use of complex judgment in their application in our 2025 Annual Report, and, during the three months ended March 31, 2026, there were no material changes to those previously disclosed.

Recent Accounting Pronouncements

See Note 3, “Recently Issued Accounting Standards,” to our condensed consolidated financial statements included elsewhere in this Quarterly Report for information regarding recently issued accounting pronouncements.

Section 107 of the JOBS Act permits us, as an “emerging growth company,” to take advantage of an extended transition period for adopting new or revised accounting standards until those standards would otherwise apply to private companies.

We have elected to avail ourselves of this exemption and, as a result, for so long as we remain an emerging growth company, unless we subsequently choose to affirmatively and irrevocably opt out of the extended transition period, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies.

Section 107 of the JOBS Act provides that we can elect to opt out of the extended transition period at any time, which election is irrevocable.

We will remain an emerging growth company, and will be able to take advantage of the foregoing exemptions, until the earliest of:

(i) the last day of the first fiscal year in which our annual gross revenues are $1.235 billion or more;

(ii) the last day of 2025;

(iii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common equity held by non-affiliates is $700 million or more as of the last business day of our most recently completed second fiscal quarter;

or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis