Clearside Biomedical, Inc. Q1 FY2024 earnings call

• Added Dr. Victor Chong as Chief Medical Officer and Tony Gibney to the Board of Directors. Victor is a retinal specialist with extensive experience in drug development. Tony brings expertise in biotech business, collaborations, finance, and M&A.
• SCS Microinjector technology has been used in thousands of clinic injections with a strong safety record (no endophthalmitis cases).
• ODYSSEY trial is progressing as planned, with top-line results expected in the third quarter of 2024. CLS-AX targets extending the time between doses for wet AMD patients.
• Cash and cash equivalents totaled approximately $35 million as of March 31, 2024, with sufficient resources to fund operations into the third quarter of 2025.

No detailed product segment financial performance with revenue contribution % provided in the transcript.

• Expect 2024 to be transformative, with ODYSSEY data readout later in the year potentially showing CLS-AX as a valuable addition to the wet AMD market.
• Cash resources will fund operations through the ODYSSEY trial data readout and support planning for CLS-AX Phase III program.

Q: What constitutes active disease as the inclusion criteria for ODYSSEY and how does it differ from other mid-stage wet AMD trials?

A: Victor Chong stated that active disease is defined by patients still having subretinal fluid, intraretinal fluid, or fluid under the retina showing leakage.

Q: Have you given further thought to the Phase III design in light of competitors' funding superiority trials to standard of care and about FDA clinical trial guidelines?

A: George Lasezkay mentioned internal planning for Phase III depending on ODYSSEY data. Victor Chong noted CLS-AX's ability to retreatment based on its own drug is a key difference. Regarding FDA guidelines, Victor said the draft guideline for wet AMD trials is over a year old and not finalized, with potential inconsistencies with practice.