EyePoint, Inc. Q3 FY2023 earnings call

Product Pipeline Advancement

• Advanced and expanded pipeline with positive masked safety data in DAVIO 2 and PAVIA Phase 2 trials for EYP-1901, and unveiled new preclinical program EYP-2301.

EYP-1901 Details

• Lead product candidate for VEGF-mediated retinal diseases, delivered via single intravitreal injection with sustained release. Upcoming key data events: DAVIO 2 top-line in early Dec, PAVIA in Q2 2024, plan to initiate third Phase 2 trial in DME (VERONA trial) in Q1 2024.

EYP-2301

• New preclinical program with TIE-2 activator razuprotafib formulated in Durasert E for wet AMD and diabetic eye disease.

Board and Leadership

• Appointed Stuart Duty to board; promoted George Elston to Executive Vice President.

For the third quarter ended September 30, 2023, total net revenue was $15.2 million compared to $10 million in the same period of 2022. Net product revenue was $0.8 million in Q3 2023 versus $9.7 million in Q3 2022. Net revenue from royalties and collaborations was $14.4 million in Q3 2023 compared to $0.3 million in Q3 2022. Operating expenses were $29.6 million in Q3 2023 versus $28.4 million in Q3 2022. Net loss was $12.6 million or $0.33 per share in Q3 2023 compared to a net loss of $18.4 million or $0.49 per share in Q3 2022. Cash and investments at September 30, 2023 totaled $136 million.

Phase 3 Plans

• Plan to initiate first Phase 3 pivotal trial for EYP-1901 as maintenance therapy in wet AMD by Q4 2024, with second trial outside the US.

Key Data Events

• Top-line data from DAVIO 2 in early Dec 2023, PAVIA in Q2 2024, Phase 2 DME trial in Q1 2024.

• Forward-looking statements may not materialize due to factors in SEC filings.
• Uncertainty in clinical trial outcomes and regulatory timelines.

Q: Were the BCVA outcome scenarios for the DAVIO 2 trial constructed in accordance with KOLs and can you elaborate on KOL feedback regarding the trial? And upon positive data, how quickly could the Phase 3 program start?

A: Jay Duker responded that BCVA ranges were considered with FDA requirements and KOL input, noting KOLs generally want a good efficacy and safety profile with numerical change in range of 3-4 letters. Regarding Phase 3, he said they believe they can start the first Phase 3 trial in the second half of 2024, and accelerated data release may not be beneficial.

Q: How does the EYLEA induction relate to the mechanism of TKIs in wet AMD and why induction is necessary?

A: Jay Duker explained it's a regulatory and derisking reason due to FDA discussions around Phase 3 trial structure, to level the playing field and ensure proper patient treatment before Phase 3.

Q: Could you talk about the dose response in the study and how you'd decide on the dose to take forward if there's no dose response?

A: Jay Duker stated they're agnostic to dose response, and if both doses work well, they'd opt for the lower dose to lower COGS.

Q: Thoughts on the BCVA scenario of minus 3 to minus 4 letters and its implications?

A: Jay Duker said minus 3 to minus 4 letters could be statistically non-inferior but may not meet KOL and investment community expectations, with a base case of minus 3 letters or better being successful.

Q: For the wet AMD program, following DAVIO 2 readout, would you request an end of Phase 2 trial meeting with FDA to guide Phase 3? What's the potential timing?

A: Jay Duker said they plan to have a clinical end to Phase 2 and CMC into Phase 2 to guide Phase 3, with potential timing in late Q1 2024 to early Q2 2024.

Q: Updates on the complement inhibitor collaboration program in 2024?

A: Jay Duker said they're excited about the collaboration but will disclose more when confident in formulation and results.

Q: Thoughts on potential future Phase 3 study sites based on BCVA outcomes?

A: George Elston and Jay Duker discussed that trial site plans depend on BCVA outcomes and standard deviation, with considerations for trial size and safety measures.

Q: Positioning 1901 as maintenance therapy vs. competitors targeting treatment naive patients; could 1901 be used for treatment naive patients and potential market loss?

A: Jay Duker said if 1901 is safe, effective, and tolerable, it could be used earlier, and market share depends on label and retina specialist use, with a focus on their current pathway.