Slide 1: ANX007 Phase 3 GA Program December 2023
ANX007 Phase 3 GA Program December 2023 Exhibit 99.3
Slide 2: Overview of ANX007 Geographic Atrophy Program
Overview of ANX007 Geographic Atrophy Program Unique MOA targeting classical complement inflammation where it starts Preclinical classical complement inhibition protected photoreceptor cell loss and function ARCHER 1st clinical demonstration of significant, dose & time-dependent vision preservation
Slide 3: ANX007 GA Phase 3 Program Overview: Potential Best-in-Class Approach
ANX007 GA Phase 3 Program Overview: Potential Best-in-Class Approach Aligned with FDA on BCVA ≥15 letter loss functional endpoint, with no requirement for surrogate structural endpoint, consistent with ARCHER Ph2 results FDA recommends injection comparator as control (e.g., placebo or approved drug)
Slide 4: Two Study Global P3 Approach Balances POS, Cost and Time
Two Study Global P3 Approach Balances POS, Cost and Time Clinical Regulatory Other Considerations Maximize clinical PTS Achieve global regulatory approval Minimize cost, time, operational complexity 1 2 3 EMA: Sham precedent & no comparator FDA: Injectable control recommended – active comparator onl
Slide 5: GA P3 Trials Overview: Replicate ARCHER & Support Global Approvals
ANX007 GA P3 Trials Overview: Replicate ARCHER & Support Global Approvals Replicate ARCHER (e.g., inclusion/ exclusion, assessments etc.) Possible enrichment criteria for sham study (based on ARCHER data) Treatment masked through 24 months** ANX007 Monthly (n = ~200) Sham (n = ~200) Primary analysis
Slide 6: Syfovre: An "Active Control" with No Observed Effect on Visual Acuity
Syfovre: An “Active Control” with No Observed Effect on Visual Acuity No apparent treatment effect on BCVA 15 across three trials and >1,400 GA patients observed Recruited generally similar patient population as ARCHER No Syfovre BCVA ≥15-letter loss data reported Modeling: best, non-significant eff
Slide 7: ARCHER I Vision Protection Supported by Three Lines of Evidence
ARCHER I Vision Protection Supported by Three Lines of Evidence 1. Observed significant time and dose-dependent protection against vision loss vs sham (BCVA) 72% risk reduction in EM arm (p=0.006) 48% risk reduction in EOM (p=0.064) BCVA ≥15-LETTER LOSS AT 2 CONSECUTIVE VISITS OR LAST VISIT % Patien
Slide 8: Next Steps
Next Steps Finalize design elements for ARCHER II and ARROW Ph3 trials Enrichment criteria for sham study Potential modifications to year 2 of sham trial (e.g., incorporate EOM dosing) Design features to ensure appropriate number of BCVA 15 events Continued partnership with EMA under PRIME designati