Clearside Biomedical, Inc. Q3 FY2023 earnings call

• Completed enrollment in ODYSSEY Phase 2b wet AMD clinical trial with top line data expected in Q3 2024. • Announced partnership with BioCryst Pharmaceuticals to expand external development pipeline. • REGENXBIO and Aura Biosciences presented positive Phase 2 safety and efficacy data using Clearside's SCS microinjector. • Bausch & Lomb secured permanent Category 1 CPT code for XIPERE in US. • Arctic Vision completed enrollment in Phase 3 clinical trials of XIPERE in uveitic macular edema in China. • CLS-AX's ODYSSEY Phase 2b trial completed recruitment, with feedback from medical community highlighting excellent safety profile and reduced injection frequency. • REGENXBIO's Phase 2 ALTITUDE trial showed ABBV-RGX-314 gene therapy well tolerated with disease progression prevention in diabetic retinopathy. • Aura Biosciences' Phase 2 trial of Belsar for choroidal melanoma showed positive efficacy with 80% tumor control and 90% visual acuity preservation, and FDA special protocol assessment for Phase 3 COMPASS trial.

No specific product segment financial performance detailed as the transcript focuses on program and partnership updates rather than traditional product segment revenue breakdowns.

• Cash and cash equivalents totaled ~$29 million as of 9/30/2023, with $5 million upfront license fee from BioCryst partnership, providing sufficient resources to fund operations into Q4 2024, including past ODYSSEY trial completion and top-line data announcement. • Believes the suprachoroidal approach and multiple partnerships represent significant future value for the company and shareholders.

• Actual results may differ materially from forward-looking statements due to factors discussed in Risk Factors sections of annual and quarterly reports and other SEC filings. • No specific operational failures discussed in detail in the transcript beyond general forward-looking statement disclaimers.

Q: Regarding ODYSSEY trial enrollment, target was 60 patients, any overshoot and attrition assumption?

A: Completed enrollment with more than 60 patients, overshot target slightly, and attrition is expected but currently happy with recruitment.

Q: Potential inflection points for REGENXBIO and Aura partnerships?

A: Aura's Phase 3 COMPASS trial to dose first patient this quarter; REGENXBIO's Phase 2 data in diabetic retinopathy encouraging with next steps to determine Phase 3 plans.

Q: Current responsibilities and work on BioCryst partnership?

A: Working with BioCryst on formulation and IND enabling studies into next year, with handoff to BioCryst once IND is filed.

Q: What to see in ODYSSEY and competitive profile?

A: Hopeful for maintenance therapy with 4-6 month dosing, believing CLS-AX has a good place in wet AMD treatment paradigm.

Q: ODYSSEY trial design, powering, and rescue treatment?

A: Trial not powered for non-inferiority/superiority, using loading doses and training sites to minimize early off-protocol treatments.

Q: FDA draft guidance on wet AMD and ODYSSEY trial design?

A: Data from ODYSSEY will guide Phase 3 proposal, currently committed to current trial design comparing to on-label aflibercept.