Vera Therapeutics (VERA) investor relations material

Recent clinical data and regulatory progress

• Positive Phase III data for Atakicept in IgAN nephropathy presented at ASN and published in NEJM; BLA filed in November with potential PDUFA date in July.

• Atakicept received breakthrough designation, with a review timeline of two plus six months.

• Two-year kidney function data published, showing efficacy and safety, including during the COVID-19 pandemic.

• Long-term extension studies and open-label programs are ongoing to assess durability and broader patient impact.

• Commercial launch preparations are advanced, with an autoinjector expected at launch and a seasoned commercial team in place.

Efficacy, safety, and patient impact

• Atakicept demonstrated the ability to maintain GFR similar to healthy individuals and reduce proteinuria and hematuria.

• Safety profile is comparable to placebo, with no increased risk of infections or opportunistic infections.

• The drug targets B cells via dual BAF-APRL inhibition, offering a novel, targeted approach without broad immunosuppression.

• Patients can self-administer a small-volume autoinjector weekly at home.

• The therapy is positioned as a foundational, disease-modifying option for IgAN and potentially other glomerular diseases.

Competitive landscape and market strategy

• Five drugs are approved for IgAN; Atakicept is the first dual BAF-APRL inhibitor and second B cell modulator.

• Differentiators include two-year GFR data, autoinjector, and broad label potential.

• Market consists of mostly young, commercially insured patients, with a distributed nephrologist base.

• Payer strategies and prescription patterns anticipate Atakicept as cornerstone therapy, complemented by standard CKD agents.

• No advisory committee is expected for approval; guidelines are expected to update soon after launch.