ABEO — Abeona Therapeutics Inc.

Summary of ABEO Q1 2026 Earnings Call

1. Key Financial Results and Metrics

• Net Product Revenue: $8.7 million for Q1 2026, a significant increase from $2.4 million in Q4 2025.
• Cost of Sales: $2.7 million, up from $1 million in the prior quarter, reflecting increased patient treatments.
• R&D Expenses: $9.6 million, including a $7 million upfront payment for the in-licensing of the PSMA-SIR-T asset; a slight decrease from $9.9 million in Q1 2025 when excluding this transaction.
• SG&A Expenses: $19.5 million, up $9.7 million year-over-year, driven by investments in commercial infrastructure.
• Net Loss: $17.1 million, or $0.30 per share, compared to a net loss of $12 million, or $0.24 per share, in Q1 2025.
• Cash Position: $168.3 million at the end of Q1 2026, down from $191.4 million at the end of 2025.

2. Strategic Updates and Business Highlights

• ZEVASKYN Launch: Activated six qualified treatment centers (QTCs) and treated five commercial patients, with strong demand indicated by over 100 identified patients in the pipeline.
• Patient Engagement: Positive feedback from treating physicians and patients, with a high percentage of commercially insured lives covered (95%).
• R&D Pipeline: In-licensed a novel engineered T-cell therapy (PSMA-SIR-T) for advanced prostate cancer, with IND filing anticipated in H2 2027.
• Market Access: Ongoing efforts to improve payer coverage and streamline insurance approval processes.

3. Forward Guidance and Outlook

• Q2 Expectations: Anticipation of treating one or two additional patients in Q2, with potential for monthly profitability starting in June 2026.
• Long-term Goals: Aim to onboard a total of seven QTCs by year-end and maintain a steady treatment cadence of one patient per month per QTC.
• Cost Management: Expect operational expenses to stabilize post the $7 million one-time R&D payment.

4. Bad News, Challenges, or Points of Concern

• Insurance Approval Process: Lengthy and complex, particularly for out-of-state Medicaid patients, which could delay treatments.
• Patient Retreatment Uncertainty: While there is a clinical need for retreatment, the timing and number of patients returning for additional cycles remain unclear.
• Operational Risks: The dependency on the successful onboarding of QTCs and the ability to manage patient flow through the biopsy and treatment processes.

5. Notable Q&A Insights

• Patient Profiles: Most treated patients are severe cases requiring multiple sheets of ZEVASKYN, indicating ongoing unmet needs.
• QTC Activation Challenges: The lengthy onboarding process involves multiple stakeholders and regulatory hurdles, which can delay patient treatment.
• Market Dynamics: The payer mix is expected to remain stable, with approximately 60% commercial and 30-33% Medicaid coverage.
• PSMA-SIR-T Confidence: The innovative structure of the PSMA-SIR-T technology is believed to overcome historical challenges faced by solid tumor CAR-T therapies, generating optimism among KOLs and the company.

This summary captures the essential elements of Abeona Therapeutics' Q1 2026 earnings call, highlighting financial performance, strategic initiatives, and key challenges while providing insights from the Q&A session.