Vera Therapeutics (VERA) R&D Day 2024 summary

Strategic vision and future plans

• Atacicept, a dual BAFF-APRIL inhibitor, is positioned as a best- and first-in-class, disease-modifying therapy for IgA nephropathy (IgAN) and other autoimmune kidney diseases, with expansion planned into hematology, rheumatology, neurology, and metabolism, and phase 3 data expected in Q2 2025 with a potential US launch in 2026.

• The clinical program is expanding beyond IgAN to include membranous nephropathy, FSGS, minimal change disease, anti-PLA2R/anti-nephrin podocytopathies, and broader autoimmune populations, targeting up to 230,000 patients in the US.

• The PIONEER phase 2 basket study will enroll diverse IgAN cohorts and other autoimmune kidney diseases, aiming for broad data at launch and operational efficiency by leveraging existing trial infrastructure, with new clinical trial initiations and data readouts planned through 2026.

• ORIGIN Extend will provide long-term follow-up and real-world data, including re-challenge after drug holidays, to inform chronic use and optimal dosing strategies, launching in Q4 2024.

• Atacicept's IP strategy and biologics exclusivity are expected to protect the franchise through at least 2038 in the US and 2037 in the EU, with ongoing work to extend this further.

Financial guidance and operational readiness

• Cash, cash equivalents, and marketable securities totaled approximately $384 million as of June 30, 2024, expected to fund operations through approval and commercial launch.

• The organization is actively scaling and attracting talent in preparation for commercialization and ongoing clinical development.

• 54.8 million shares outstanding as of August 5, 2024.

• No current plans for partnerships; the company is advancing all programs independently to maximize value creation.

Clinical and regulatory milestones

• Phase 2b 96-week data for Atacicept in IgAN will be presented at ASN Kidney Week in Q4 2024, providing the longest dataset for a B-cell modulator in this indication.

• Phase 3 ORIGIN 3 trial is fully enrolled for the primary endpoint as of September 2024, with top-line results expected in Q2 2025, a BLA submission for accelerated approval in the second half of 2025, and a projected US launch in 2026.

• PIONEER and ORIGIN Extend programs will generate additional data in 2025, supporting label expansion and broader patient access, with multiple new clinical trials and data readouts scheduled through 2026.