EyePoint — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total net revenue for the quarter ended September 30, 2026, was $0.8 million, a decrease from $1.0 million in the same period of 2025.
• Total revenues for the nine months ended September 30, 2026, were $1.959 million, compared to $30.751 million for the same period in 2025.
• Operating expenses for the quarter ended September 30, 2026, totaled $97.6 million, an increase from $63.0 million in the corresponding 2025 period, primarily driven by ongoing Phase 3 clinical trials.
• Net loss for the quarter ended September 30, 2026, was $95.6 million ($1.07 per share), compared to a net loss of $59.7 million ($0.85 per share) in 2025.
• Net loss for the nine months ended September 30, 2026, was $274.9 million ($3.15 per share), compared to $164.4 million ($2.35 per share) in 2025.
• Cash, cash equivalents, and short-term investments totaled $118 million as of September 30, 2026, down from $306 million as of December 31, 2025.
• Total assets were $166.1 million as of September 30, 2026, compared to $364.0 million as of December 31, 2025.

Guidance and Future Outlook:

• Management expects cash on hand, combined with $10 million raised subsequent to quarter-end via an "at-the-market" equity facility and anticipated operational adjustments, to fund operations into the late third quarter of 2027.
• Topline data for the Phase 3 COMO and CAPRI clinical trials in Diabetic Macular Edema (DME) is expected in early Q4 2027.
• The company intends to actively evaluate business development, financing, and cost reduction opportunities to extend its cash runway.

Business Segments and Product Lines:

• DURAVYU (vorolanib intravitreal insert):
  • DME Program: The Phase 2 VERONA trial met its primary endpoint, showing a +7.1-letter improvement in best-corrected visual acuity (BCVA) and a 76-micron reduction in central subfield thickness at Week 24. 73% of patients remained supplement-free through Week 24 versus 50% in the aflibercept control arm. The Phase 3 COMO and CAPRI trials are fully enrolled with over 550 patients.
  • Wet AMD Program: The Phase 3 LUGANO and LUCIA trials did not achieve the primary endpoint of statistical non-inferiority in mean change in BCVA versus aflibercept. However, both trials achieved key secondary endpoints, including a 42% (LUGANO) and 38% (LUCIA) reduction in treatment burden with superior results versus aflibercept (p-value <0.0001). In a pooled analysis of patients supplement-free up to Week 56, DURAVYU was statistically non-inferior in mean change in BCVA.
  • Strategic Shift: The company will conclude the wet AMD program before the full second year of the Phase 3 studies to focus resources on the DME program while maintaining a safety database for a potential DME New Drug Application.
• Conferences: Presented data on DURAVYU's multi-mechanism of action and Phase 3 results at the ASRS Annual Meeting (July 2026), Retina Society Annual Meeting (September 2026), and Euretina Congress/AAO Annual Meeting (October 2026).

Market and Competitive Landscape:

• DURAVYU is being evaluated against on-label aflibercept (2 mg) as the control in Phase 3 trials.
• DURAVYU demonstrates a multi-mechanism of action targeting both VEGF and inflammatory IL-6 pathways, distinct from existing anti-VEGF large molecule ligand blocking therapies.
• The company maintains a favorable safety profile with no observed occurrences of insert migration, anterior chamber opacities, free-floating drug particles, or retinal vasculitis in the Phase 3 wet AMD trials.

Risks and Challenges:

• Clinical trial results may not be predictive of future results, and interim data are subject to change.
• Regulatory approval timelines and pathways for DURAVYU are uncertain.
• The company faces risks regarding its ability to continue as a going concern if cash resources are insufficient.
• Potential additional costs related to strategic prioritization and workforce reduction.
• Compliance with Nasdaq's minimum bid requirement.
• FDA warning letter pertaining to the Watertown, MA manufacturing facility.
• Dependence on contract research organizations and outside vendors.

Management Commentary and Tone:

• CEO Jay S. Duker expressed conviction in the DME program, citing the positive Phase 2 VERONA results, multi-MOA activity, and the opportunity to evaluate the program in two fully enrolled pivotal trials within a year.
• CFO George O. Elston emphasized that "capital discipline is now one of our highest priorities," with the objective of preserving resources for pivotal DME data while delivering COMO and CAPRI to the utmost standard.

Other Key Points:

• The Board of Directors approved a strategic prioritization resulting in an approximately 53% workforce reduction and operational adjustments.
• These strategic changes are expected to generate estimated annualized savings of approximately $30 million.
• The company raised an additional $10 million via an "at-the-market" equity facility subsequent to the quarter-end.
• DURAVYU has been conditionally accepted by the FDA as the proprietary name for EYP-1901.
• Vorolanib is licensed to EyePoint exclusively by Equinox Sciences for the localized treatment of all ophthalmic diseases outside of China, Macao, Hong Kong, and Taiwan.