EyePoint Pharmaceuticals, Inc. Q1 FY2026 earnings call

• 2026 started with strong execution, Duravu program approaching pivotal inflection point. Upcoming Lugano and Lucia readouts for wet AMD phase three trials. • Phase three wet AMD trials on track for mid-year top-line data, DME phase three program with rapid enrollment progress towards full enrollment in Q3 2026. • DuraView program has robust and differentiated clinical data, phase two trials showed durable efficacy, favorable safety profile. Multi-mechanism of action with virolinib blocking VEGF, PDGF and inhibiting IL-6 signaling. • Phase III wet AMD trials designed with non-inferiority pathway, comparing to on-label filibrocept, evaluating six-month redosing. Phase III DME program uses non-inferiority design, unlabeled flibercept control, six-month redosing. • Commercial readiness activities ongoing with addition of CCO, expansion in key areas. CMC facility in Northbridge, MA online supporting CMC submission and commercial supply preparation.

Total net revenue for the quarter ended March 31, 2026 was $0.7 million compared to $24.5 million in the prior year. Operating expenses were $88 million in Q1 2026 vs. $73 million in Q1 2025. Cash and investments ended the first quarter at $223 million. Revenue contribution details not provided as net revenue is very low with major drop from prior year due to deferred revenue recognition from prior agreements.

• Anticipate top-line data from Phase III wet-AMD trial Lugano this summer, Lucia trial shortly after. • Expect top-line data from Phase III DME program in second half of 2027. • Current cash position expected to fund operations into Q4 2027 beyond key milestones for Phase III wet AMD program.

Q: On DME side, speak to investigator interest in TKI sustained delivery treatment like Duravue and differences/similarities vs wet AMD.

A: Investigators excited, similar patient-centric approach. 90 wet AMD investigators accepted to DME trials showing enthusiasm.

Q: Comment on supplement trigger criteria in Phase 3 vs Phase 2 and meaningful supplement rate for commercial uptake.

A: Supplements handled with sensitivity analyses in NDA submission. FDA doesn't set strict line, but non-inferior margin is primary endpoint. Real-world supplementation not a failure, could have latitude for acceptance.

Q: In ongoing wet AMD studies, comment on blinded rescue rates and tracking.

A: Small team reviews supplementations, no disclosure of aggregated rate. Anticipate phase three supplementation rates less than phase two due to tightened criteria, reinjection at month six, and majority naive patients.

Q: For fixed dose regimen in Lugano, ask about patients receiving third dose at week 56 and safety.

A: Fixed dose regimen, no relation to patient state. Extensive preclinical safety, no maximally tolerated dose found in rabbits. Upcoming DMC meeting in May to review masked safety.

Q: What seen in masked safety data and impact on DSMD review.

A: No comment on individual SAEs/AEs, total data consistent with prior trials, no new safety concerns.

Q: Competition between Duravue and other long-acting TKIs/biologics.

A: Not zero-sum game, room for multiple competitors. Duravue has multi-MOA, better delivery, potential for better visual acuity. Real-world data shows need for more durable agents as reported by ASRS.

Q: Safety for Lugano data and expectations/disclosure.

A: Safety similar to prior trials, no big difference in AEs. Expect complete AE tables in top line release.