Elutia
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Elutia (ELUT) investor relations material

Elutia Q3 2026 earnings summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Q3 2026 earnings summary5 Nov, 2026

Executive summary

  • NXT-41x’s GLP rabbit study met prespecified endpoints; FDA submission is planned for Q4 2026, with clearance expected in 2027 and launch planned for 2H 2027–2028.

  • $26M in financing and asset-sale proceeds was secured without an equity offering; management expects available capital to support development through anticipated clearance and the first full commercial year.

  • Continuing-operations sales grew 20.4% YoY, while higher NXT-41/NXT-41x R&D widened the continuing-operations loss.

  • Following divestitures, the portfolio is focused on cardiovascular products and development of NXT-41 and antibiotic-eluting NXT-41x.

Financial highlights

  • Q3 continuing-operations net sales were $1.137M vs. $0.944M; nine-month sales were $3.306M vs. $2.007M.

  • Q3 operating loss was $6.896M vs. $5.869M; continuing-operations net loss was $6.503M vs. $1.044M.

  • Q3 net loss was $1.285M vs. $3.868M, including $5.218M income from discontinued operations.

  • Q3 adjusted EBITDA loss was $5.551M vs. $3.403M; nine-month adjusted EBITDA loss was $15.194M vs. $10.521M.

  • Cash and cash equivalents were $29.1M at September 30, 2026.

Outlook and guidance

  • NXT-41x FDA submission is planned for Q4 2026; clearance is anticipated in 2027, with a soft launch in 2H 2027 and full commercial launch in 2028, subject to FDA review.

  • NXT-41, on a separate pathway and not intended for commercialization, was expected to receive an FDA clearance decision in Q4 2026.

  • Automated coating capacity is designed to support at least $300M in revenue and gross margin above 80% at scale.

  • Management expects existing cash to fund operating expenses and capital needs for at least one year after issuance; operating losses and negative operating cash flow are expected to continue.

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Frequently asked questions

Elutia Inc., formerly known as Aziyo Biologics, Inc., is a commercial-stage company that focuses on developing and commercializing drug-eluting biomatrix technology to improve surgical outcomes. This technology is applied in products such as the CanGaroo Envelope, which is used to stabilize implantable cardiac devices like pacemakers and defibrillators, and SimpliDerm Acellular Dermal Matrix, which is utilized primarily in breast reconstruction following mastectomy. Elutia's mission revolves around humanizing medicine to ensure patients can thrive without the compromise, addressing the challenges associated with medical device implant failures and post-surgical complications. By integrating drug-eluting biologic technology with natural biologic material and extended antibiotic release, Elutia aims to optimize device implantation and soft tissue reconstruction, ensuring implant stability and promoting wound healing. Elutia Inc. is headquartered in Silver Spring, Maryland, and its shares are listed on the NASDAQ.