Elutia (ELUT) Q3 2026 earnings summary

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.