Vera Therapeutics (VERA) R&D Day 2024 summary

Strategic vision and future plans

• Atacicept, a dual BAFF-APRIL inhibitor, is positioned as a potential best- and first-in-class therapy for IgA nephropathy (IgAN) and other autoimmune diseases, with phase 3 data expected in Q2 2025 and a potential US commercial launch in 2026.

• Expansion plans include broadening clinical trials to cover all IgAN patient subtypes, additional autoimmune kidney diseases, and future indications in hematology, rheumatology, neurology, and metabolism.

• The PIONEER phase 2 basket study will enroll diverse IgAN cohorts, including those previously excluded, and expand into membranous nephropathy, FSGS, minimal change disease, and anti-PLA2R/anti-nephrin podocytopathies.

• ORIGIN Extend will provide long-term follow-up and access for trial participants, launching in Q4 2024, to assess chronic therapy and drug holiday effects.

• Future expansion may include non-renal autoimmune indications, with ongoing IP strategy to extend exclusivity beyond 2038.

Financial guidance and operational readiness

• Cash, cash equivalents, and marketable securities totaled $384 million as of June 30, 2024, funding operations through approval and supporting scaling for commercial launch.

• Company is resourced for potential commercial launch and ongoing clinical development, with 54.8 million shares outstanding as of August 5, 2024.

• No current plans for external partnerships; all programs are advancing independently.

• Multiple near- and mid-term catalysts include phase 2b 96-week data in Q4 2024, phase 3 top-line results in Q2 2025, BLA submission in 2H 2025, and new study data through 2026.

• Patent and biologics exclusivity expected through at least 2038 in the US and 2037 in the EU, with additional IP strategies in development.

Clinical and scientific differentiation

• Atacicept is the only B-cell modulator in IgAN with two-year phase 2 data, at-home self-administration, and over 90% patient retention at 1.5 years.

• Phase 2 data demonstrate significant reduction in proteinuria, normalization of eGFR slope to healthy population rates, and potential for functional cure.

• The dual BAFF-APRIL inhibition mechanism is seen as superior to single-target approaches, with potential benefits in disease modification and safety profile.

• At-home, self-administered weekly dosing is a key differentiator, with a monthly dosing study set to begin in 2025.

• The program is designed for capital and operational efficiency, leveraging overlapping trial sites and streamlined enrollment.