Clearside Biomedical, Inc.

Clearside did not report revenue, EPS, or gross margin on the call; it referred investors to the press release for the fourth quarter and full-year 2024 financial results. Cash and cash equivalents were approximately $20 million as of December 31, 2024, and management said that should fund planned operations into the fourth quarter of 2025. For guidance, the company said it is still preparing to start CLS-AX Phase 3 in the second half of 2025 while actively pursuing funding options, including a potential partnership with one or more third parties.

George Lasezkay framed Clearside as the leader in suprachoroidal drug delivery and repeatedly emphasized growing interest from retinal specialists and pharma partners. His tone was upbeat and strategic, pointing to the positive ODYSSEY Phase 2b wet AMD results and the FDA end-of-Phase-2 alignment as key validation of CLS-AX. He also highlighted progress across partnered programs in Asia-Pacific and other indications as evidence that the platform is broadly applicable.

Charlie Deignan kept the financial update brief, saying the company would rely on its press release for the detailed fourth-quarter and full-year numbers. He stated Clearside had approximately $20 million in cash and cash equivalents at December 31, 2024, with runway into the fourth quarter of 2025. He also said the company is actively pursuing ways to fund the CLS-AX Phase 3 program, including a possible partnership, and declined to provide a specific cost estimate, though he referenced other Phase 3 studies at roughly $55 million to $60 million per study.

Analysts focused on the Phase 3 design, enrollment timing, trial size, powering assumptions, and financing. Management said the treatment-naive population should enroll in about 12 months or slightly less, that the FDA agreed the safety assessment would be treated as one merged arm rather than split by dosing interval, and that the trial uses a 4.5-letter non-inferiority margin with assumptions similar to VABYSMO. On funding, management said the program is still intended to start in the second half of 2025, but only if financing is secured, and they are exploring partnerships and other options. Victor Chong also explained that re-dosing is guided by OCT biomarkers and AI-assisted assessment, while rescue is reserved for worsening vision/anatomy and is expected to be rare.