Clearside Biomedical, Inc. Q4 FY2024 earnings call

Clearside is the proven leader in suprachoroidal drug delivery with over 15,000 suprachoroidal injections performed to date. Positive results from the ODYSSEY Phase 2b wet AMD clinical trial led to a successful end of Phase 2 meeting with the FDA regarding CLS-AX's Phase 3 plans. Partners like Arctic Vision, REGENXBIO/AbbVie, Aura Biosciences, and BioCryst are making progress with their respective suprachoroidal development efforts. Victor Chong outlined Phase 3 plans for CLS-AX, including trial design with exclusion of variable patients, flexible dosing, and targeting treatment-naive patients. Internal pipeline work on small molecules for geographic atrophy was also mentioned.

As of December 31, 2024, cash and cash equivalents totaled approximately $20 million, with sufficient resources to fund operations into the fourth quarter of 2025. Actively pursuing options to fund the CLS-AX Phase 3 program, including partnerships. Phase 3 trial planned to start in the second half of 2024.

Actual results may differ materially from forward-looking statements due to various factors including those discussed in the risk factors section of the annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings.

Q: What are the potential factors that could contribute to a BCVA change over 10 letter, so the CST change?

A: Victor talks about patient variability, elderly patients, and OCT criteria where vision changes may not be reliable.

Q: By implementing these criteria before randomization, do you expect to have any negative impact on enrollment speed or future market adoption when the CLS-AX eventually reaches the market?

A: Victor says inclusion criteria won't significantly impact label or recruitment as it's scientifically justified.

Q: Can you talk about the powering assumption in the Phase 3 trial? And also, if you would share, do you have any insights on how payers think about reimbursement for a potential three to six-month flexible dosing label for CLS-AX compared to competitors?

A: Victor discusses payer research and Phase 3 assumptions, mentioning flexible dosing and potential competitive pricing.

Q: Can you please elaborate on redosing criteria, which, as I understand, relies on OCT biomarkers and how these interplay with the rescue criteria of the BCVA loss and the fluid gain? And also, where does the physician's discretion come in in redosing decision? Because I think that's always a big variability factor.

A: Victor explains redosing and rescue criteria, AI tools, and that physician discretion is involved but criteria are similar to approved drugs.