Abeona Therapeutics (ABEO) Q3 2026 earnings summary

Executive summary

• ZEVASKYN Q3 net revenue was $13.5M, up 18% QoQ; six treatments were completed in the quarter and 15 since launch.

• Acquired ABO-801, a Phase III-ready EoE candidate, and announced a $30M private placement to support pipeline development and commercialization.

Financial highlights

• Q3 ZEVASKYN revenue was $13.5M versus $11.4M in Q2; 9M 2026 revenue was $33.6M versus $0.4M in 9M 2025.

• Q3 operating loss was $13.0M and net loss was $4.8M, or $0.08 per share; 9M net loss was $42.1M, or $0.74 per share.

• Q3 cost of sales was $5.7M, R&D $3.7M and SG&A $17.1M; Q2 comparatives were $4.2M, $5.0M and $15.8M, respectively.

• Cash, cash equivalents and short-term investments totaled $134.9M at Sept. 30, excluding subsequent PIPE proceeds; runway was expected to exceed 12 months.

• Q3 results included a $6.5M noncash gain from warrant-liability remeasurement; 9M R&D was $18.2M, including a $7.0M PSMA SIR-T upfront license expense.

Outlook and guidance

• ZEVASKYN treatment timing may remain variable through year-end due to payer, QTC and manufacturing-shutdown timing; some biopsy slots may shift to early 2027.

• ABO-801’s planned Phase III study targets ~400 patients, comparing 3 mg once daily with placebo; initiation is anticipated mid-2027, with results around end-2028.

• The proposed trial includes co-primary symptom and histology endpoints at week 12 and a week 24 durability assessment; a Type C FDA meeting will address study design and one-study NDA sufficiency.

• ABO-801 topline data are targeted in ~2 years, with potential approval ~1 year later; potential peak annual sales are $750M+ from 2030 onward.

• Q3 liquidity was expected to fund operations for at least 12 months; losses and negative operating cash flows are expected to continue, with additional financing potentially needed for planned activities.