Investor Day Slides

AXPAXLI Clinical Trials & Data - AXPAXLI has demonstrated proof-of-concept in three Phase 1 trials for retinal diseases [2, 130] - In a Phase 1 US trial, 80% of wet AMD patients remained rescue-free per protocol for up to 10 months [5, 134] - Phase 1 Australia Trial showed Monotherapy Activity with CSFT improving from 484µm at baseline to 244µm at Month 9, and BCVA improving from 56 letters (20/80) at baseline to 81 letters (20/25) at Month 9 [3] - HELIOS Phase 1 study in NPDR showed 231% ≥2-step DRSS improvement in AXPAXLI arm at week 48 compared to 0% in sham [261] - In HELIOS Phase 1 study, 0% of patients in the AXPAXLI arm developed PDR or CI-DME at Week 48, compared to 375% in the sham arm [248, 263] SOL-1 Trial - SOL-1 is a multi-center, double-masked, randomized, parallel-group trial with ~150 subjects per group [29, 74] - The primary endpoint of SOL-1 is the proportion of subjects who maintained visual acuity, defined as <15 ETDRS letters of BCVA loss at Week 36 [7, 74] - SOL-1 trial design has been adapted to fit the FDA guidance requirements, including a Special Protocol Assessment (SPA) [48, 50, 143] - Enrollment in the SOL-1 trial has been rapid, with 60 sites activated and 151 subjects enrolled as of May 2024 [91, 99] SOL-R Trial - SOL-R is a Phase 3 wet AMD study designed to demonstrate that AXPAXLI Q6M is non-inferior to fixed-dose aflibercept 2 mg Q8W [114] - The SOL-R trial will enroll 825 total subjects and is being conducted at regulatory risk [114] - SOL-R will capture patients who fail loading or randomization in SOL-1, as well as enroll similar wet AMD patients from other sites [116, 117] Market Opportunity - The estimated US market potential for retinal vascular diseases in 2024 is 92 million, including 165 million for wet AMD, 27 million for moderate-severe NPDR, 14 million for RVO, 17 million for DME, and 17 million for PDR [16]