Elutia Secures Up to $26 Million to Fund NXT-41x Through Commercial Launch; Reports Second Quarter 2026 Results
Rhea-AI Summary
Elutia (Nasdaq: ELUT) reported second quarter 2026 results and outlined funding and timelines for its NXT-41/NXT-41x programs. The company secured up to $26 million of additional non-equity capital: a $15 million credit facility (including $10 million already funded and $5 million contingent on NXT-41x FDA clearance) and up to $11 million from the signed SimpliDerm divestiture. Elutia also expects release of $8 million in BioEnvelope escrow in 4Q 2026, and cites up to $34 million of additional cash from signed transactions.
An independent blinded survey of 50 plastic surgeons showed strong interest in NXT-41x, with 96% interested in adopting it and 92% willing to support hospital committee approval. Elutia continues to expect FDA clearance decisions for NXT-41 in 4Q 2026 and NXT-41x in 1H 2027, with a soft launch in 2H 2027 and full commercial launch in 2028. Q2 2026 net sales were $2.4 million versus $2.7 million a year ago; GAAP gross margin was 59.6%, adjusted gross margin 70.7%, and net loss from continuing operations $7.6 million. Cash and cash equivalents were $19.9 million at June 30, 2026.
Positive
- Up to $26 million of new non-equity capital secured for NXT-41x
- Additional liquidity of up to $34 million expected from signed transactions
- GAAP gross margin improved to 59.6% from 52.9% in Q2 2025
- Adjusted gross margin increased to 70.7% from 62.7% in Q2 2025
- Total operating expenses decreased to $9.4 million from $9.8 million year over year
- Blinded surgeon survey shows 96% interested in adopting NXT-41x
- NXT-41x FDA clearance decision expected in 1H 2027; full launch planned for 2028
Negative
- Net sales declined to $2.4 million from $2.7 million year over year
- Net loss from continuing operations was $7.6 million in Q2 2026
- Adjusted EBITDA loss widened to $4.6 million from $3.0 million year over year
- Cash and cash equivalents were $19.9 million versus total assets of $43.6 million at June 30, 2026
Market Reaction – ELUT
Following this news, ELUT has gained 1.33%, reflecting a mild positive market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.87. Trading volume is very high at 3.5x the average, suggesting strong buying interest.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
Previous Earnings Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Q1 earnings report | Positive | -1.0% | Progress update and improved margins were followed by a -0.96% reaction. |
| Mar 11 | FY2025 earnings report | Positive | +5.5% | BioEnvelope sale and NXT-41 regulatory progress preceded a 5.5% reaction. |
| Jan 12 | Preliminary earnings report | Positive | -4.8% | Preliminary sales growth and liquidity update preceded a -4.76% reaction. |
| Nov 06 | Q3 earnings report | Positive | -5.0% | BioEnvelope transaction and NXT-41x funding update preceded a -5% reaction. |
| May 08 | Q1 earnings report | Positive | +4.5% | EluPro sales growth and partnership news preceded a 4.52% reaction. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched earnings announcements produced mixed reactions, with both positive and negative price responses despite generally constructive operating updates.
Key Terms
drug-eluting biomatrix medical
gaap financial
adjusted ebitda financial
95% confidence interval technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-Track
- Funded through launch: secured up to
$26 million of capital without an equity offering - The unmet need is real:
86% of surgeons surveyed say the matrices they use today increase infection risk - The demand is strong:
96% of surgeons surveyed are interested in adopting NXT-41x;92% responded they would champion it at their hospital value analysis committee - On track: NXT-41 FDA clearance decision expected in 4Q 2026; NXT-41x FDA clearance decision expected in 1H 2027
GAITHERSBURG, Md., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix technologies, today provided a business update and announced financial results for the second quarter ended June 30, 2026.
| “We have intentionally focused Elutia where our strengths create the greatest value for patients and shareholders,” said Dr. Randy Mills, Chief Executive Officer of Elutia. “We believe we are now funded through the anticipated clearance and full commercial launch of NXT-41x, our antibiotic-eluting biomatrix for use in plastic and reconstructive surgical procedures. And we did it without an equity offering. “As we approach anticipated FDA clearance decisions and launch, surgeon interest in NXT-41x has exceeded our expectations. In an independent study of 50 board-certified plastic and reconstructive surgeons, “Having successfully created value with this technology in the pacemaker market, we are now applying it to a larger market with a substantially greater unmet need. And we believe we have the team and capital to execute.” |
Capital Secured to Support NXT-41x Through Clearance and Commercial Launch
Elutia has secured up to
$15 million credit facility, including$10 million funded at closing and an additional$5 million available following NXT-41x FDA clearance- Up to
$11 million from the SimpliDerm divestiture, including$8 million in cash at closing and up to$3 million in contingent technology transfer and commercial milestone payments
In addition, the Company anticipates receiving the full
Independent Blinded Survey Validates Surgeon Demand for NXT-41x
An independent market research firm conducted a blinded survey of 50 board-certified plastic and reconstructive surgeons across 28 states. The surgeons average 11.6 years in practice and perform about 140 complex reconstructive procedures annually.
Surgeons Say the Problem Is Real
- Surgeons estimate a
17% surgical-site infection rate in the published literature for these procedures. 86% (95% confidence interval (CI): 74–93% ) report that matrices used today increase infection risk.
Surgeons View NXT-41x as Differentiated and Mechanistically Sound
98% (CI: 90–99.6% ) rated NXT-41x new and different from products available today.96% (CI: 87–99% ) rated the combination of rifampin and minocycline effective, with64% (CI: 50–76% ) describing it as extremely effective at reducing surgical site infections. No respondents rated the combination ineffective.
Surgeon Intent to Adopt NXT-41x Is Strong
100% (CI: 93–100% ) indicated they would use NXT-41x in diabetic patients and in patients with high BMI, who together represent approximately one third of all reconstruction patients.96% (CI: 87–99% ) expressed interest in incorporating NXT-41x into their general practice.92% (CI: 81–97% ) indicated willingness to approach their hospital value analysis committee in support of NXT-41x.
Interest measures are based on ratings of 4 or 5 on a five-point scale. All results are reported with
Regulatory Review and Manufacturing Progressing on Schedule
Regulatory and development activities for both NXT-41 (biologic surgical matrix without drug) and NXT-41x continue to advance according to plan. Elutia recently held a productive meeting with the FDA regarding the NXT-41 submission, which remains on track. The Company continues to expect FDA clearance for NXT-41 in the fourth quarter of 2026 and for NXT-41x in the first half of 2027.
Elutia also completed the installation and operational qualification of its automated drug-coating system for commercial manufacturing. The system is designed to support target gross margins in excess of
Product Divestitures Further Sharpen the Company’s Focus
On July 16, 2026, Elutia signed a definitive agreement to sell its SimpliDerm business for up to
Funded Catalysts Ahead
| Milestone | Expected Timing |
| SimpliDerm business divestiture closing | 3Q 2026 |
| Potential cardiovascular business transaction | 2H 2026 |
| 4Q 2026 | |
| NXT-41 FDA clearance decision | 4Q 2026 |
| NXT-41x FDA clearance decision | 1H 2027 |
| NXT-41x commercial soft launch | 2H 2027 |
| NXT-41x full commercial launch | 2028 |
Second Quarter 2026 Financial Results
Net sales and operating results discussed below reflect continuing operations. For the three-month period ended June 30, 2026, as compared to the same period of 2025:
- Overall net sales were
$2.4 million , compared to$2.7 million . The decrease was the result of$0.7 million reduction in SimpliDerm revenue due to a production disruption with the product’s contract manufacturer, offset by a$0.4 million increase in Cardiovascular revenue due to the transition back to direct sales. - Gross margin on a GAAP basis was
59.6% , compared to52.9% . - Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was
70.7% , compared to62.7% . A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables. - Total operating expenses were
$9.4 million , compared to$9.8 million . The decrease was driven by a$1.9 million reduction in net litigation costs, partially offset by a$1.5 million increase in research and development expense supporting the NXT-41 and NXT-41x programs. - Loss from operations was
$8.0 million , compared to$8.4 million . - Net loss from continuing operations was
$7.6 million , compared to$7.1 million . - There was no loss from discontinued operations in the second quarter of 2026, compared to a loss of
$2.5 million in the second quarter of 2025. - Net loss was
$7.6 million , compared to$9.6 million . - Adjusted EBITDA (a non-GAAP measure that excludes from net loss certain non-operating, non-cash and non-recurring items) was a loss of
$4.6 million , compared to a loss of$3.0 million . A reconciliation of net loss to adjusted EBITDA is included in the accompanying financial tables. - Cash and cash equivalents at June 30, 2026 were
$19.9 million . This cash position is expected to be augmented by up to an additional$34 million from signed transactions, including$10 million already received from Avenue Capital Group pursuant to a new loan agreement,$8 million held in escrow in connection with the 2025 divestiture of the BioEnvelope business, up to$11 million from the sale of the SimpliDerm business and an additional$5 million available from the Avenue Capital loan facility following FDA clearance of NXT-41x.
Conference Call
Elutia will host a conference call on August 13, 2026 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time to discuss its second quarter 2026 financial results and business performance.
The conference call can be accessed using the following information:
Webcast: Click here
Dial-In: Click here
To receive the dial-in number, as well as your personalized PIN, you must register at the above link. Once registered, you will also have the option to have the system dial out to you once the conference call begins. If you forget your PIN prior to the conference call, you can simply re-register.
Please log in approximately 10 minutes prior to the scheduled start time. A live and archived webcast of the event will be available on the "Investors" section of the Elutia website at http://investors.elutia.com/.
About Elutia
Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com.
Non-GAAP Disclosure
In addition to the Company’s financial results determined in accordance with U.S. GAAP, the Company provides non-GAAP measures that it determines to be useful in evaluating its operating performance and liquidity. The Company presents in this press release the following non-GAAP financial measures: earnings before interest, taxes, depreciation and amortization ("EBITDA"), adjusted earnings before interest, taxes, depreciation and amortization ("adjusted EBITDA"), adjusted gross margin and adjusted gross profit. The Company defines EBITDA as GAAP net loss excluding interest expense, income tax expense, depreciation and amortization, and the Company defines adjusted EBITDA as EBITDA excluding income or loss from discontinued operations, stock-based compensation, FiberCel and VBM litigation costs, loss or gain on revaluation of warrant liability, warrant issuance expenses and loss or gain on revaluation of revenue interest obligation. The Company defines adjusted gross profit and adjusted gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. Management believes that presentation of non-GAAP financial measures provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. The Company uses this non-GAAP financial information to establish budgets, manage the Company’s business, and set incentive and compensation arrangements. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For a reconciliation of these non-GAAP measures to GAAP, see below "Non-GAAP Reconciliations of EBITDA and Adjusted EBITDA" and "Non-GAAP Reconciliations of Adjusted Gross Profit and Adjusted Gross Margin."
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements and information concerning our future interactions with the U.S. Food and Drug Administration ("FDA") regarding NXT-41 and NXT-41x; expectations for FDA clearance of NXT-41 and NXT-41x, including the timing and anticipated success thereof; preparations for the commercial launch of NXT-41x, including the timing, scale and anticipated success thereof; the sufficiency of our capital resources to fund the Company through anticipated FDA clearance and the first full year of commercial launch of NXT-41x without an equity offering; the availability of the additional
Investors:
Elutia Investor Relations
ir@elutia.com
| ELUTIA INC. | ||||||||
| CONSOLIDATED BALANCE SHEET DATA | ||||||||
| (Unaudited, in thousands) | ||||||||
| Assets | June 30, 2026 | December 31, 2025 | ||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 19,896 | $ | 36,350 | ||||
| Accounts receivable, net | 1,438 | 1,734 | ||||||
| Inventory | 2,649 | 2,617 | ||||||
| Insurance receivables of litigation costs | 3,854 | 4,846 | ||||||
| Prepaid expense and other current assets | 9,378 | 10,271 | ||||||
| Total current assets | 37,215 | 55,818 | ||||||
| Property and equipment, net | 2,922 | 2,511 | ||||||
| Intangible assets, net | 990 | 1,529 | ||||||
| Operating lease right-of-use assets, and other | 2,522 | 2,492 | ||||||
| Total assets | $ | 43,649 | $ | 62,350 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable and accrued expenses | $ | 8,329 | $ | 9,143 | ||||
| Current portion of revenue interest obligation | 6,412 | 4,400 | ||||||
| Contingent liability for legal proceedings | 5,619 | 11,241 | ||||||
| Current operating lease liabilities | 685 | 355 | ||||||
| Total current liabilities | 21,045 | 25,139 | ||||||
| Long-term revenue interest obligation | — | 2,828 | ||||||
| Warrant liability | 3,163 | 3,124 | ||||||
| Long-term operating lease liabilities | 3,695 | 3,587 | ||||||
| Total liabilities | 27,903 | 34,678 | ||||||
| Stockholders' equity: | ||||||||
| Common stock | 44 | 43 | ||||||
| Additional paid-in capital | 207,030 | 203,842 | ||||||
| Accumulated deficit | (191,328 | ) | (176,213 | ) | ||||
| Total stockholders' equity | 15,746 | 27,672 | ||||||
| Total liabilities and stockholders' equity | $ | 43,649 | $ | 62,350 | ||||
| ELUTIA INC. | ||||||||||||||||||
| CONSOLIDATED STATEMENT OF OPERATIONS | ||||||||||||||||||
| (Unaudited, in thousands, except share and per share data) | ||||||||||||||||||
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||
| Net sales | $ | 2,427 | $ | 2,747 | $ | 5,541 | $ | 5,698 | ||||||||||
| Cost of goods sold | 980 | 1,294 | 2,292 | 2,863 | ||||||||||||||
| Gross profit | 1,447 | 1,453 | 3,249 | 2,835 | ||||||||||||||
| Operating expenses: | ||||||||||||||||||
| Sales and marketing | 1,366 | 1,273 | 2,846 | 2,268 | ||||||||||||||
| General and administrative | 3,454 | 3,552 | 7,545 | 7,273 | ||||||||||||||
| Research and development | 2,527 | 989 | 4,500 | 1,860 | ||||||||||||||
| Litigation costs, net | 2,057 | 4,004 | 2,663 | 6,576 | ||||||||||||||
| Total operating expenses | 9,404 | 9,818 | 17,554 | 17,977 | ||||||||||||||
| Loss from operations | (7,957 | ) | (8,365 | ) | (14,305 | ) | (15,142 | ) | ||||||||||
| Interest income, net | (35 | ) | (491 | ) | (143 | ) | (307 | ) | ||||||||||
| Other (income) expense, net | (284 | ) | (791 | ) | 1,300 | (5,873 | ) | |||||||||||
| Loss before provision for income taxes | (7,638 | ) | (7,083 | ) | (15,462 | ) | (8,962 | ) | ||||||||||
| Provision for income taxes | 8 | 8 | 78 | 16 | ||||||||||||||
| Net loss from continuing operations | (7,646 | ) | (7,091 | ) | (15,540 | ) | (8,978 | ) | ||||||||||
| Loss income from discontinued operations | — | (2,519 | ) | 425 | (4,565 | ) | ||||||||||||
| Net loss | $ | (7,646 | ) | $ | (9,610 | ) | $ | (15,115 | ) | $ | (13,543 | ) | ||||||
| Net loss per share — basic | $ | (0.17 | ) | $ | (0.23 | ) | $ | (0.35 | ) | $ | (0.34 | ) | ||||||
| Net loss per share — diluted | $ | (0.17 | ) | $ | (0.26 | ) | $ | (0.35 | ) | $ | (0.47 | ) | ||||||
| Weighted average common shares outstanding — basic | 44,223,722 | 41,782,556 | 43,622,360 | 40,239,372 | ||||||||||||||
| Weighted average common shares outstanding — diluted | 44,223,722 | 46,308,642 | 43,622,360 | 44,765,897 | ||||||||||||||
| ELUTIA INC. | |||||||||||||||
| NON-GAAP GROSS PROFIT AND NON-GAAP GROSS MARGIN RECONCILIATIONS | |||||||||||||||
| (Unaudited, in thousands) | |||||||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net sales | $ | 2,427 | $ | 2,747 | $ | 5,541 | $ | 5,698 | |||||||
| Gross profit | 1,447 | 1,453 | 3,249 | 2,835 | |||||||||||
| Intangible asset amortization expense | 270 | 270 | 540 | 542 | |||||||||||
| Adjusted gross profit (Non-GAAP) | $ | 1,717 | $ | 1,723 | $ | 3,789 | $ | 3,377 | |||||||
| Gross margin | 59.6 | % | 52.9 | % | 58.6 | % | 49.8 | % | |||||||
| Adjusted gross margin percentage (Non-GAAP) | 70.7 | % | 62.7 | % | 68.4 | % | 59.3 | % | |||||||
| ELUTIA INC. | |||||||||||||||
| EBITDA AND ADJUSTED EBITDA RECONCILIATIONS | |||||||||||||||
| (Unaudited, in thousands) | |||||||||||||||
| Three months ended June 30, | Six months ended June 30, | ||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||
| Net loss | $ | (7,646 | ) | $ | (9,610 | ) | $ | (15,115 | ) | $ | (13,543 | ) | |||
| Interest income expense, net(1) | (35 | ) | (491 | ) | (143 | ) | (307 | ) | |||||||
| Provision for income taxes | 8 | 8 | 78 | 16 | |||||||||||
| Depreciation and amortization | 348 | 312 | 679 | 598 | |||||||||||
| Earnings before interest, taxes, depreciation and amortization ("EBITDA") (Non-GAAP) | (7,325 | ) | (9,781 | ) | (14,501 | ) | (13,236 | ) | |||||||
| Loss (income) from discontinued operations(2) | — | 2,519 | (425 | ) | 4,565 | ||||||||||
| Stock-based compensation | 905 | 1,028 | 1,836 | 2,116 | |||||||||||
| Litigation costs, net(3) | 2,057 | 4,004 | 2,663 | 6,576 | |||||||||||
| (Gain) loss on revaluation of warrant liability(4) | (226 | ) | (2,233 | ) | 1,429 | (7,420 | ) | ||||||||
| Warrant issuance expenses | — | — | — | 105 | |||||||||||
| Loss on revaluation of revenue interest obligation(5) | — | 1,442 | — | 1,442 | |||||||||||
| Adjusted EBITDA (Non-GAAP) | $ | (4,589 | ) | $ | (3,021 | ) | $ | (8,998 | ) | $ | (5,852 | ) | |||
(1) Represents interest expense recorded on all outstanding long-term debt as well as the revenue interest obligation.
(2) Represents the financial results of the BioEnvelope business sold to Boston Scientific Corporation on October 1, 2025.
(3) Represents litigation costs consisting primarily of legal fees and the estimated and actual costs to resolve the outstanding FiberCel and VBM litigation cases offset by the amounts recovered and recoverable under insurance, indemnity and contribution agreements for such costs.
(4) Represents the non-cash revaluation of Common Warrants and Prefunded Warrants issued in connection with a private offering in September 2023 and registered direct offerings in June 2024 and February 2025.
(5) Represents the non-cash revaluation of the revenue interest obligation. At each reporting period, the value of the revenue interest obligation is re-measured based on current estimates of future payments, with changes to be recorded in the consolidated statements of operations using the catch-up method.
