Vivoryon Therapeutics (VVY) Corporate presentation summary

Clinical evidence and therapeutic focus

• Statistically significant improvement in eGFR observed in two independent Phase 2 studies, with robust and consistent effects, especially in diabetic subgroups.

• Varoglutamstat demonstrated a strong safety profile in over 400 participants across more than two years.

• The drug targets inflammation and fibrosis, offering a complementary mechanism to current standard-of-care therapies.

• Planned Phase 2b study in stage 3b/4 diabetic kidney disease (DKD) aims for interim data at 15 months and full data at 24 months post-study start, subject to funding.

• Large unmet need exists in advanced DKD, with millions affected in the US and EU and high risk of progression to kidney failure.

Market opportunity and value creation

• First oral agent to show improvement in kidney function, addressing a substantial patient population with limited options.

• Defined clinical and regulatory path with key value inflection points within 24 months.

• Funding requirement estimated at €15M for interim data and €30M for full data readout and potential Phase 3/partnership.

• Intellectual property protection extends to 2044 in the US, with potential for further extension.

• Potential for expansion into other immune-mediated and fibrotic diseases, including rare kidney diseases and cardiovascular conditions.

Study design and patient impact

• Planned double-blind, placebo-controlled Phase 2b study in DKD will enroll patients with eGFR 20-60 mL/min/1.73m², all on standard of care.

• Primary endpoint is mean change in eGFR at 48 weeks; secondary endpoints include albuminuria and biomarkers of inflammation/fibrosis.

• Varoglutamstat is well-positioned for patients with advanced disease, where current therapies are insufficient and risk of dialysis is high.

• Consistent and pronounced treatment effect observed in patients with lower baseline eGFR and diabetes.

• High tolerability and low discontinuation rates compared to existing therapies, with a differentiated mechanism of action.