Vivoryon Therapeutics (VVY) investor relations material

Clinical evidence and therapeutic focus

• Statistically significant improvement in eGFR observed in two independent Phase 2 studies, with robust and consistent benefit over placebo and excellent safety profile in over 400 subjects treated for more than two years.

• Varoglutamstat, a first-in-class QPCT/L inhibitor, demonstrated a larger treatment effect in diabetic subgroups and in patients with more impaired kidney function.

• The drug targets inflammation and fibrosis, offering a complementary mechanism to current standard of care therapies for diabetic kidney disease (DKD).

• Planned Phase 2b study in DKD (stage 3b/4) aims for interim data within 15 months and primary data within 24 months, subject to financing.

• Strong intellectual property position with U.S. composition of matter patent to 2044 and potential for Hatch-Waxman extension.

Unmet need and market opportunity

• DKD is a leading cause of chronic kidney disease, with millions affected in the US and EU and high risk of progression to kidney failure.

• Current therapies (SGLT2i, GLP-1RA) delay progression but do not stabilize or reverse kidney function decline, and a significant proportion of patients are ineligible or discontinue treatment.

• Varoglutamstat is positioned to address advanced DKD where treatment options are limited and aims to stabilize kidney function and prevent progression to dialysis or transplant.

• The planned clinical program targets a large, growing market with substantial unmet need and potential for blockbuster status.

Clinical development and value creation pathway

• Phase 2b study will be a double-blind, placebo-controlled trial in stage 3b/4 DKD patients on top of standard of care, with eGFR as the primary endpoint and secondary endpoints including albuminuria and biomarkers.

• Funding of €15M is needed to reach interim data and €30M for full data readout and potential Phase 3/partnership.

• The clinical path is clearly defined, with key value inflection points expected within 15–24 months of study initiation.

• Additional development opportunities exist for QPCT/L inhibitors in rare kidney diseases and other immune-mediated conditions.