Clearside Biomedical, Inc. Q4 FY2022 earnings call

• Over the past year, Clearside reinforced its leadership in suprachoroidal space therapeutics delivery, with launch and commercialization of XIPERE by Bausch + Lomb, positive data from CLS-AX's Phase 1/2a OASIS trial, and promising data from partners using the SCS Microinjector. - CLS-AX's OASIS trial showed favorable safety, with 2/3 of patients potentially going at least 6 months without additional treatment, and a favorable safety profile as axitinib is well-characterized. - XIPERE was launched in the US nearly a year ago by Bausch + Lomb, with over a thousand retinal physicians trained in SCS Microinjector use. - Partners like Aura and REGENXBIO have positive trial data, and suprachoroidal drug delivery is more widely accepted by the retinal community. - Cash and cash equivalents totaled ~$48.3 million as of Dec 31, 2022, with sufficient resources to fund planned operations into Q2 2024.

No specific absolute financial performance or revenue contribution percentages for product segments were detailed in the transcript. However, it was mentioned that the company has various development and commercialization programs with partners, and the growing acceptance of the suprachoroidal delivery platform provides opportunities.

• As of Dec 31, 2022, cash and cash equivalents were approximately $48.3 million, and the company expects to have sufficient resources to fund planned operations into the second quarter of 2024. - The company will provide an update on any impact on current cash runway guidance as it finalizes Phase 2 clinical trial plans for CLS-AX.

Forward-looking statements made during the call may differ materially from actual results due to various important factors, including those discussed in the Risk Factors section of the Annual Report on Form 10-K for the year ended December 31, 2021, the quarterly report on Form 10-Q for the quarter ended September 30, 2022, and other SEC filings available on the company's website.

Q: Annabel Samimy asked about how CLS-AX may do against faricimab and licensing activity.

A: George Lasezkay responded that they switched the comparator to aflibercept to be in line with FDA guidelines and that there has been more licensing interest with ongoing conversations.

Q: Serge Belanger asked about changes to the ODYSSEY trial and CLS-AX beyond Wet AMD.

A: George Lasezkay responded that the comparator in ODYSSEY will be aflibercept on label and that the company is focusing on ODYSSEY in Wet AMD patients currently.

Q: Jonathan Wolleben asked about ODYSSEY trial changes and cost.

A: George Lasezkay and Charles Deignan responded that protocol adjustments are being made and that Wet AMD studies usually cost 150,000 to 200,000, but the exact cost for ODYSSEY was still being finalized.

Q: Unidentified Analyst asked about CLS-AX vs faricimab commercially.

A: George Lasezkay responded that there could be a future comparison with faricimab as it may be necessary commercially.

Q: Yi Chen asked about fourth quarter revenue and 2023 operating expenses.

A: Charles Deignan responded that fourth quarter revenue wasn't solely from SCS Microinjector sales and that operating expenses in 2023 were expected to be lean with no major increases other than Phase 2 program costs.