[Management View]
EyePoint Pharmaceuticals advanced its lead candidate, DuraVu, through rapid phase 3 enrollment in wet AMD and aligned phase 3 DME trial initiation while maintaining an extended cash runway. Management highlighted the regulatory endorsement of their clinical design and emphasized DuraVu’s differentiated multi-mechanism targeting VEGF and IL-6.

[Outlook]
Management expects DuraVu to be the only tyrosine kinase inhibitor in phase 3 development for DME in 2026, leveraging investigator relationships from existing wet AMD infrastructure. Top-line data for DuraVu in wet AMD is expected in mid-2026, with first patient dosing for DME trials anticipated in Q1 2026.

[Financial Performance]
For the period ended September 30, 2025, total net revenue was $1 million, compared to $10.5 million in the prior year period. This decrease was primarily driven by the recognition of deferred revenue related to the company’s 2023 agreement for the license of YUTIQ product rights in the prior year. Operating expenses totaled $63 million, compared to $43.3 million in the prior year period, driven by phase 3 trial costs for DuraVu in wet AMD. Net loss was $59.7 million, or $0.85 per share, compared to a net loss of $29.4 million, or $0.54 per share, in the prior year period.

[Q&A Highlights]
Question 1: Can you refresh us for the wet AMD population in the US? What percent of patients are treated every four weeks, every six weeks, every eight weeks, or longer? And what is your latest view on how doctors will use DuraVu if available in that context?
Answer: Approximately 20% of wet AMD patients have to be treated monthly regardless of the drug they are using. Even with newer extended duration agents, 50% of the eyes can't go longer than every eight weeks. DuraVu phase 2 data shows that about 65% of patients do not require any supplement injection with anti-VEGF, and about 90% require zero or one injection over a six-month period. This suggests that DuraVu may offer a significant advantage in reducing treatment burden.

Question 2: Regarding DME, can you provide additional color on how you're structuring your enrollment criteria to provide the broadest reach in the DME marketplace relative to competitors in the long-acting TKI space?
Answer: The phase 3 DME program will enroll patients with active DME, both treatment-naive and previously treated, using aflibercept on label as the control arm. DuraVu will be dosed every six months. EyePoint Pharmaceuticals has strong relationships with investigators from the wet AMD study, which will be leveraged for rapid enrollment in the DME program.

Question 3: I wanted to ask about the use of the blended endpoint in the pivotal wet AMD and DME trials. Why do you believe the blended endpoint is the best approach?
Answer: The blended endpoint, counting two visits for the primary endpoint, prevents missing data and captures recovery of vision if there is a loss in one visit. This approach decreases variability and increases the power of the study. The FDA has approved the use of blended endpoints for both wet AMD and DME trials.

Question 4: Could you talk about the differentiation in IL-6 inhibition and how that could translate into clinical benefits in DME versus an anti-VEGF only approach?
Answer: Vorolanib, the active ingredient in DuraVu, inhibits IL-6 signaling through JAK1 receptor blockage, in addition to its known inhibition of PDGF and all VEGF receptors. This multi-mechanism of action may be particularly effective in treating multifactorial diseases such as DME and wet AMD, offering a significant improvement over current anti-VEGF therapies.

Question 5: Assuming Lugano and Lucia meet their non-inferiority endpoint, does your statistical analysis plan allow for test superiority? How do you expect clinicians to interpret those data related to on-label EYLEA compared to potential competitors pursuing superiority claims based on less frequent dosing?
Answer: The analysis plan allows for hierarchical testing of superiority after non-inferiority endpoints. If DuraVu produces superior visual outcomes compared to on-label aflibercept, it would position DuraVu as a premium medication. Superiority against on-label aflibercept is more relevant from a retina specialty perspective than superiority versus a single dose.

[Sentiment Analysis]
Analysts and management expressed optimism about DuraVu’s potential to transform the treatment paradigm in retinal diseases. The tone was confident regarding the differentiated clinical profile and the anticipated competitive positioning of DuraVu.

[Quarterly Comparison]
| Metric | Q3 2025 | Q3 2024 |
|-----------------------|-----------------|-----------------|
| Net Revenue | $1 million | $10.5 million |
| Operating Expenses | $63 million | $43.3 million |
| Net Loss | $59.7 million | $29.4 million |
| Loss per Share | $0.85 | $0.54 |
| Cash and Investments | $204 million | $371 million |

[Risks and Concerns]
Risks include potential delays in clinical trial timelines, regulatory hurdles, and the competitive landscape in retinal disease treatments. The financial performance reflects increased operating expenses due to phase 3 trial costs, which may continue to impact net revenue and profitability.

[Final Takeaway]
EyePoint Pharmaceuticals is advancing its lead candidate, DuraVu, through rapid phase 3 enrollment in wet AMD and initiating phase 3 DME trials. The company maintains a strong cash position to support operations into Q4 2027. Management is optimistic about DuraVu’s differentiated multi-mechanism targeting VEGF and IL-6, which may offer significant advantages in reducing treatment burden and improving clinical outcomes in retinal diseases. Investors should monitor upcoming milestones, including top-line data for wet AMD expected in mid-2026 and first patient dosing for DME trials in Q1 2026.