Vivoryon Therapeutics (VVY) mwb online Health Care Conference summary

Market context and medical need

• Chronic kidney disease (CKD) affects 1 in 10 adults in Europe, with global prevalence expected to rise from 0.75 to 1.2 billion in the next decade due to aging, diabetes, and hypertension.

• Dialysis and kidney transplants are costly, with dialysis alone costing about EUR 80,000 per patient annually and CKD treatment consuming 2-3% of healthcare budgets in Europe.

• Current therapies slow CKD progression by 30-40% but do not halt or reverse kidney function decline.

• Environmental impact of dialysis is significant, equating to the carbon footprint of 700,000 cars in Germany.

• The market for CKD therapies is projected to quadruple in the next 10 years.

Innovation and clinical development

• Varoglutamstat, a first-in-class QPCTL inhibitor, aims to stabilize or improve kidney function by blocking inflammatory and fibrotic peptide activation.

• Two independent phase II studies (VIVIAD in Europe, VIVA-MIND in the US) showed statistically significant and sustained improvement in eGFR over two years.

• The drug demonstrated a four to five-fold greater effect on eGFR compared to current standard-of-care treatments.

• Safety profile is favorable, with low discontinuation rates and no significant difference in adverse events versus placebo.

• Market exclusivity is secured until at least 2044, with potential extensions to 2050.

Forward strategy and financial outlook

• A new phase II study targeting advanced diabetic kidney disease (stages III/IV) is planned, with 100-150 patients and a 12-month treatment period; top-line data expected two years post-initiation.

• Study costs are estimated at EUR 12-18 million; current cash runway extends to January 2026, with additional funding required.

• Commercialization will likely involve a partnership or M&A with a larger pharma company post-study.

• Market entry is anticipated in the early 2030s, following a three-year phase III trial after the next study.

• Pipeline includes additional QPCTL inhibitors, increasing the attractiveness for potential acquirers.