AI Earnings Predictions for Elutia Inc. (ELUT)

EX-99.1

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EX-99.1

Exhibit 99.1

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Elutia Secures Up to $26 Million to Fund NXT-41x Through Commercial Launch; Reports Second Quarter 2026 Results

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Independent Blinded Survey of 50 Plastic Surgeons Validates Demand; NXT-41 and NXT-41x Remain On-Track

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●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

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GAITHERSBURG, Md., August 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.

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“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.

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“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, 86% said matrices used today increase infection risk, 96% believed our antibiotic combination would be effective at preventing infection, and 92% said they would help get NXT-41x approved at their hospital’s value analysis committee.

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“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.”

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Capital Secured to Support NXT-41x Through Clearance and Commercial Launch

Elutia has secured up to $26 million of additional capital to support the Company through the anticipated clearance of NXT-41x and its first full year of commercial launch in 2028, without an equity offering:

●$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 $8 million held in escrow from the 2025 divestiture of the BioEnvelope business, with release expected in the fourth quarter of this year.

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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.

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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, with 64% (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 95% Wilson confidence intervals; where responses were unanimous, the lower bound of the interval is 93%.

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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 installati

EX-99.1

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EX-99.1

Exhibit 99.1

Elutia Reports First Quarter 2026 Results and Highlights NXT-41x Progress Toward $1.5 Billion U.S. Plastic and Reconstructive Surgery Market

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●NXT-41 review advancing collaboratively with FDA, informing NXT-41x submission preparations

●Brought a new automated manufacturing process online, supporting a gross margin target of more than 80% at scale

●Chief Commercial Officer Pete Ligotti's initial surgeon engagement confirming significant unmet need and market opportunity

●Strong balance sheet with $36.5 million in cash and escrowed proceeds from the BioEnvelope business divestiture

●Conference call today at 5:00 p.m. ET / 2:00 p.m. PT

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GAITHERSBURG, Md., May 14, 2026 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix technologies, today reported a business update and financial results for the first quarter ended March 31, 2026.

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Dr. Randy Mills, CEO of Elutia, said: "Up to 20% of women undergoing reconstructive surgery after mastectomy develop serious infections. To us, that is unacceptable. That's why we're developing NXT-41x.

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"This quarter, we advanced every facet of our mission. The FDA review of NXT-41 is progressing well and is providing valuable insights for the NXT-41x submission. Our new automated manufacturing process is installed and operating, supporting gross margin targets above 80% at scale. Lastly, Pete Ligotti, our new Chief Commercial Officer, is in the field with surgeons, and their feedback confirms both the size and severity of the need.

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"It is increasingly clear that in the estimated $1.5 billion breast reconstructive surgery market, NXT-41x has the potential to be a blockbuster and improve outcomes for women with breast cancer. I'm proud of what this team has accomplished and their unwavering commitment to humanizing medicine so patients can thrive without compromise."

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Business Highlights

NXT-41 510(k) Review Advancing. FDA review of the 510(k) submission for NXT-41, the base biologic matrix, is progressing through a collaborative dialogue with the agency. Anticipated clearance is on track for the fourth quarter of 2026. The Company's interactions with the FDA during this review have helped to refine the submission package for NXT-41x, an antibiotic-eluting product, with anticipated clearance in the first half of 2027.

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Manufacturing Automation Supports an Expected Gross Margin Above 80%. Elutia advanced startup work on the at-scale production equipment required for NXT-41x, including a robotic coating system used to apply the drug-eluting layer to the biologic matrix. The Company expects this manufacturing platform to support a gross margin in excess of 80%, while enabling pricing designed to capture significant market share.

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Commercial Launch Confidence Building. Pete Ligotti, Chief Commercial Officer, has spent his first months at Elutia in direct engagement with surgeons across the U.S. breast reconstruction community. Surgeon feedback is confirming the magnitude of the unmet need, with post-operative infection rates of 15 to 20 percent in a $1.5 billion U.S. market that has seen no meaningful innovation in the standard of care. Elutia is conducting quantitative market research to independently validate the scale of the opportunity, helping refine target accounts, patient populations and commercialization priorities ahead of launch.

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Strategic Processes for SimpliDerm and Cardiovascular Advancing. The previously announced exploration of a SimpliDerm divestiture is progressing well. Separately, the Company has also received multiple inbound inquiries for the acquisition of its Cardiovascular product line and is evaluating the opportunity. Elutia will provide further updates as appropriate.

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Balance Sheet. Total cash and escrow funds at March 31, 2026, were $36.5 million, comprised of $28.5 million in cash on hand and $8.0 million held in escrow related to the BioEnvelope business divestiture, with the escrowed funds expected to be released in the fourth quarter of 2026.

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First Quarter 2026 Financial Results

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Net sales and operating results discussed below reflect continuing operations. For the three-month period ended March 31, 2026, as compared to the same period of 2025:

●Overall net sales were $3.1 million, compared to $3.0 million, an increase of 6%.

●Net sales of SimpliDerm were $2.1 million, compared to $2.6 million.

●Net sales of Cardiovascular products were $1.0 million, compared to $0.3 million.

●Gross margin on a GAAP basis was 57.9%, compared to 46.8%.

●Adjusted gross margin (a non-GAAP measure which excludes non-cash amortization of intangibles) was 66.5%, compared to 55.9%. A reconciliation of GAAP gross margin to adjusted gross margin is included in the accompanying financial tables.

●Total operating expenses were $8.2 million, consistent with the prior year period.

●Net loss from continuing opera

ELUTIA INC._March 3, 2026 0001708527false00017085272026-03-032026-03-03 ​ ​ ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 ​

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): March 3, 2026

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ELUTIA INC.

(Exact name of registrant as specified in its charter) ​

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Delaware 001-39577 47-4790334

(State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.)

​ 20 Firstfield Road Gaithersburg, MD 20878 (Address of principal executive offices) (Zip Code) ​ (240) 247-1170 (Registrant’s telephone number, include area code) ​ N/A (Former name or former address, if changed since last report) ​

​ Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ​

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

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☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

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☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​ Securities registered pursuant to Section 12(b) of the Act: ​

Title of each class ​ ​ ​ Trading Symbols ​ ​ ​ Name of each exchange on which registered

Class A Common Stock, $0.001 par value per share

ELUT

The Nasdaq Capital Market

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). ​ Emerging growth company ☐ ​ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ ​ ​ ​ ​

Item 2.02 Results of Operations and Financial Condition.

On March 11, 2026, Elutia Inc. (the “Company” or “Elutia”) issued a press release announcing its results for the fourth quarter and year ended December 31, 2025. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. ​ The information in this Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No. ​ Exhibit Description

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99.1 ​ Press Release of Elutia Inc. dated March 11, 2026

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104 ​ Cover Page Interactive Data File (formatted as Inline XBRL document)

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SIGNATURES

​ Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ​

ELUTIA INC.

Date: March 11, 2026 By: /s/ Matthew Ferguson

Matthew Ferguson

Chief Financial Officer

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