Vera Therapeutics (VERA) 7th Annual Evercore ISI HealthCONx Conference summary

Clinical development and data highlights

• Phase 2 trial demonstrated atacicept stabilized kidney function in young IgA nephropathy patients over two years, a first in the field.

• Phase 3 trial is fully enrolled, with primary endpoint data expected in Q2 2025, supporting a BLA filing in the second half of 2025.

• Atacicept acts as a dual inhibitor of BAFF and APRIL, showing immune modulation without immune suppression, even during COVID-19.

• Two-year follow-up showed an eGFR rate of loss of -0.6 mL/min/year, outperforming other therapies in preserving kidney function.

• Expansion studies are underway for additional IgA nephropathy populations and adjacent autoimmune kidney diseases.

Market opportunity and regulatory pathway

• IgA nephropathy represents a $6–$10 billion market, with about 160,000 patients in the US; current studies aim to address the full patient population.

• Accelerated approval is expected based on proteinuria reduction, with full approval following two-year eGFR data; label may broaden post full approval.

• FDA has granted breakthrough designation, enabling frequent engagement and a clear regulatory roadmap.

• Current pricing benchmarks for similar therapies are $150,000–$170,000 per patient per year, with expectations for higher value due to GFR stabilization.

Commercial strategy and future plans

• Commercial preparations are well underway, with a growing team and strong connections to the nephrology community.

• Atacicept will launch as a weekly, self-administered injection, with over 90% patient retention over two years.

• A dose exploration study for once-monthly dosing is planned for 2025 as part of lifecycle management.

• Adjacent indications and next-generation formulations are being explored to expand the product's reach.

• Company is well capitalized with $670 million in cash, funding operations through key milestones including phase 3 readout, BLA filing, and launch.