Financial Data and Key Metrics Changes - The company ended Q3 2025 with approximately $345 million in cash, not including around $445 million in net proceeds from an October equity financing [48] - The financial strength provides flexibility for top-line data from registrational programs and preparation for commercialization [50] Business Line Data and Key Metrics Changes - The registrational studies for XPAXLY in Wet AMD (SOL1 and SOLAR) are progressing well, with SOLAR reaching its target randomization of 555 subjects [6][31] - The SOL1 trial has over 95% patient retention, which is exceptional for retina trials [27] Market Data and Key Metrics Changes - The global annual anti-VEGF market is estimated at approximately $15 billion, with significant untapped opportunities in Wet AMD and diabetic retinal disease [16] - In diabetic retinopathy, fewer than 1% of the 6.4 million NPDR patients in the U.S. receive treatment, indicating a large market expansion opportunity [17] Company Strategy and Development Direction - The company aims to redefine the retina experience through a strategic triad: potential superiority label, market expansion, and immediate adoptability of XPAXLY [10][52] - The Helios program is designed to pursue a broad diabetic retinopathy label, including DME, with a single registrational program [47] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of XPAXLY to break the cycle of pricing pressures and commoditization in the retina market [12][14] - Positive feedback from payers indicates a strong market preparation for XPAXLY, emphasizing its potential to deliver better outcomes and lower treatment burdens [49] Other Important Information - The company is committed to maintaining high trial integrity and has received no safety signals to date from independent monitoring [30] - The design of the Helios trials includes a novel ordinal endpoint that captures a broader range of patient responses, which is expected to increase the probability of success [40][43] Q&A Session Summary Question: Initial label expectations for Wet AMD - Management expects a superiority label based on SOL1, with flexibility in dosing intervals [59][60] Question: Expected patient populations in Helios trials - Management indicated confidence in obtaining a broad label that encompasses all diabetic eye disease without needing separate DME trials [68] Question: Progress of NPDR studies - Management confirmed that the process for NPDR studies began immediately after funding, leveraging existing site relationships for efficient enrollment [90] Question: Risks associated with the ordinal DRSS endpoint - Management expressed great confidence in the ordinal endpoint, citing overwhelming success in previous studies [96][98] Question: Enrollment timeline for Helios 2 trial - Management believes there will be no issues completing the trials efficiently due to high demand and enthusiasm from both patients and investigators [105]