- **CLS-AX Phase 3 Advancement**: FDA-aligned design with flexible dosing (12-24 weeks) and no rescue therapy, targeting $12B wet AMD market.
- **Partnership Momentum**: 2 Phase 3 trials underway, 2 regulatory approvals in Asia, and BioCryst initiating DME trials in 2025.
- **Financial Position**: $20M cash runway to Q4 2025; pursuing funding for Phase 3 with potential partnerships.
- **Competitive Edge**: Only TKI with multi-dosing data and 6-month durability; AI-driven OCT biomarkers reduce variability.
- **Market Potential**: Flexible dosing aligns with clinical practice, lower COGS vs biologics, and payer support for value-based pricing.

**【CEO Opening Remarks】**
- Clearside is the leader in suprachoroidal (SCS) delivery with over 15,000 injections performed using the SCS Microinjector.
- CLS-AX for wet AMD has FDA alignment on Phase 3 plans, with partners advancing 2 Phase 3 trials and 2 regulatory approvals in Asia.
- Partnerships include Arctic Vision (ARCATUS in China/Australia/Singapore), REGENXBIO (diabetic retinopathy Phase 3), Aura Biosciences (choroidal melanoma Phase 3), and BioCryst (DME clinical testing in 2025).

**【CMO Clinical Update】**
- CLS-AX Phase 3 design: 2 non-inferiority trials targeting treatment-naive patients with BCVA 20/80-20/32 and CST <500µm.
- Key features: flexible dosing (every 12-24 weeks) based on OCT biomarkers, AI-driven PTI assessment, and no rescue therapy (differentiator vs competitors).
- Subgroup analysis shows stable BCVA and CST in patients not requiring additional treatment, supporting reduced variability in Phase 3.
- Competitive positioning: only TKI with multi-dosing data and up to 6-month durability, targeting $12B wet AMD market.

**【CFO Financial Update】**
- Cash balance of $20M as of Q4 2024, sufficient for operations into Q4 2025.
- Actively pursuing funding for CLS-AX Phase 3, including potential partnerships.
- Prior experience: successfully ran 2 concurrent Phase 3 trials for RVO in 2024.

**【Q&A Highlights】**
- **Trial Design**: Enrollment expected in H2 2024, targeting 900 patients. FDA supports merged safety analysis across dosing intervals.
- **Cost & Funding**: Phase 3 cost estimated ~$55-60M, comparable to competitors. No timeline disclosed for partnership announcements.
- **Market Adoption**: Flexible dosing (1-6 months) aligns with clinical practice, potential for lower COGS vs biologics.
- **Regulatory Risk**: No rescue criteria reduces variability; Phase 3 design mirrors approved drugs (EYLEA high dose, VABYSMO).
- **Payer Insights**: Payer research supports value of flexible dosing; competitive pricing expected due to small molecule/device combo.

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