Vera Therapeutics (VERA) investor relations material

Key clinical developments

• Lead product Atacicept showed strong results in Phase III for IgA nephropathy, with plans to file a BLA in Q4 and anticipated market entry by mid-next year.

• Phase II and III data demonstrated consistent efficacy, including a 42% placebo-adjusted reduction in proteinuria and stabilization of GFR, surpassing FDA thresholds.

• Long-term data showed patients on Atacicept could avoid dialysis or transplant, marking a transformative advance in kidney disease management.

• Open-label extension studies are ongoing, with high patient enthusiasm and positive real-world experience using the auto-injector.

• Monthly dosing studies and a new fusion protein (VT-109) are in progress to expand the product profile and dosing flexibility.

Market opportunity and commercialization

• IgA nephropathy is a significant unmet need, with an estimated 160,000–200,000 US patients and a potential $10–20 billion market.

• Diagnosis rates are expected to rise as new therapies become available, expanding the addressable market.

• Commercial launch preparations are advanced, with sales leadership in place and strong engagement with the nephrology and patient communities.

• The auto-injector is well received, offering convenient at-home administration and high patient retention over two years.

• The company is leveraging synergies across clinical sites and capital efficiency for ongoing and future studies.

Regulatory and competitive landscape

• BLA submission is on track for Q4, with no major gating factors and expectations for priority review.

• Regulatory discussions are collaborative, and there is optimism for a competitive label based on the unique mechanism and robust data.

• The company is closely monitoring competitor data but remains confident in its differentiated results and future market position.

• Additional studies (PIONEER) are enrolling broader IgAN populations and exploring other autoimmune kidney diseases.

• The pipeline includes plans to expand into membranous nephropathy, FSGS, MCD, and potentially other autoimmune indications.