EyePoint, Inc. Q2 FY2023 earnings call

• The sale of YUTIQ in May 2023 transformed EyePoint into a pure play development stage biopharmaceutical company, allowing debt retirement and extended cash runway.
• EYP-1901 is fully enrolled in two oversubscribed Phase II clinical trials: DAVIO 2 for wet AMD and PAVIA for NPDR. EYP-1901 is an investigational sustained release therapy with vorolanib, targeting VEGF-mediated retinal diseases.
• Preclinical data for EYP-1901 showed potential neuroprotective effects of vorolanib. Plan to initiate Phase II trial for DME in Q1 2024.
• Top-line data from DAVIO 2 expected in December, PAVIA in Q2 2024, and DME trial dosing in Q1 2024.

For the second quarter ended June 30, 2023, total net revenue was $9.1 million. Net product revenue was $5.3 million, down from $11.3 million in Q2 2022 due to the sale of YUTIQ and discontinuation of DEXYCU marketing. Royalty and collaboration revenue totaled $3.8 million in Q2 2023, up from $0.3 million in the corresponding period in 2022, primarily due to deferred revenue recognition from the YUTIQ sale.

• Anticipate top-line data from Phase II DAVIO 2 clinical trial in December 2023.
• Dose first patient in Phase II clinical trial of EYP-1901 for DME in Q1 2024.
• Read out top-line data from Phase II PAVIA trial for NPDR in Q2 2024.
• Advance discovery stage pipeline including wholly-owned products and partnered programs.

• Forward-looking statements subject to actual results differing due to factors in Form 10-K and other SEC filings, including clinical development, regulatory, and product success risks.

Q: Tyler Van Buren asked about comparing DAVIO 2 patients' baseline visual acuity and CST to DAVIO 1 and safety during clinical trials.

A: Dr. Jay Duker responded that DAVIO 2 represents a more typical wet AMD population, with better visual acuity and drier CST than DAVIO 1. Safety of EYP-1901 is supported by Durasert platform's clean safety record and preclinical data.

Q: Yatin Suneja asked about baseline injections of Phase II patients and re-treatment plan in Phase III.

A: Dr. Jay Duker stated baseline injection data not collated yet, but Phase III goal is non-inferiority in visual acuity vs Eylea control, with plan to retreat every six months.

Q: Jennifer Kim asked about NPDR opportunity and Home OCT.

A: Dr. Jay Duker noted large NPDR opportunity due to high treatment frequency with current therapies, and Home OCT as early warning system.

Q: Colleen Kusy asked about rescue criteria in Phase II and Phase III design.

A: Dr. Jay Duker explained rescue criteria vary, Phase II lowered visual acuity supplement standard to 5 letters, Phase III plans non-inferiority vs Eylea; George Elston discussed funding Phase III via partnerships or equity raises.

Q: Daniel Catalin asked about strategy for other approved anti-VEGFs in wet AMD.

A: Dr. Jay Duker stated wet AMD pivotal trial control arm will be on-label EYLEA.

Q: Sean Kim asked about Phase III label seeking and drug-device combo.

A: Dr. Jay Duker said current plan is six-month re-treatment in pivotal, and EYP-1901 is drug-device combo with preloaded, sterilized injectors.

Q: I-Eh Jen asked about YUTIQ revenue amortization and label seeking for re-treatment.

A: George Elston explained YUTIQ revenue amortized over two years for accounting, Dr. Jay Duker stated current plan is six-month re-treatment in pivotal, with post-approval study possibly adjusting timeframe.

Q: Chaitanya Gollakota asked about competitive landscape for maintenance treatment of wet AMD.

A: Dr. Jay Duker said no significant changes, EYP-1901 offers sustained release unlike extended duration anti-VEGFs.