Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Investor Presentation (September 2025)
36 slides from Vivoryon Therapeutics's investor presentation, September 2025
Slide 1: Innovation to Improve Kidney Health Outcomes
Innovation to Improve Kidney Health Outcomes Lead Program: Varoglutamstat in Diabetic Kidney Disease September 2025 Vivoryon Therapeutics N.V.
Slide 2: Important Notice and Disclaimer
Important Notice and Disclaimer This document has been prepared by Vivoryon Therapeutics N.V. (the “Company” or “We”) strictly only for discussion purposes. This document does not constitute or form part of any offer or invitation to sell or issue, any offer or inducement or invitation or commitment
Slide 3: Vivoryon's approach and expertise positions company for future growth
Vivoryon’s approach and expertise positions company for future growth and supports development of innovative oral therapies for kidney disease High medical need Therapies needed that can stabilize or improve kidney function and prevent progression to kidney failure / end-stage kidney disease (ESKD)
Slide 4: Inhibiting QPCTL has potential to halt the progressive course of kidney disease
Inhibiting QPCTL has potential to halt the progressive course of kidney disease through unique approach to tackle inflammation and fibrosis Huge unmet Current treatments do not stabilize / improve kidney function medical need leaving significant risk of ESRD (dialysis, transplant) or cardiovascular
Slide 5: Varoglutamstat's target QPCTL plays a crucial role in protein maturation and inflammation
Varoglutamstat’s target QPCTL plays a crucial role in protein maturation and inflammation Chronic kidney tissue damage can lead to higher expression of QPCTL which can accelerate inflammation and organ fibrosis, organ dysfunction and finally kidney failure 1. Peptides including pro-inflammatory chem
Slide 6: Pyroglutamated peptides produced by QPCT/L are central to pro-inflammatory/pro-fibrotic pathways
Pyroglutamated peptides produced by QPCT/L are a central part of the pro- inflammatory/pro-fibrotic pathways in kidney disease Varoglutamstat impaired kidney improved kidney QPCT/L substrate protein QPCT/L QPCT/L Kidney function eGFR Kidney function pyroglutamate pyroglutamate Fibrosis formation for
Slide 7: Two independent randomized double-blind placebo-controlled Phase 2 studies
Vivoryon has evaluated varoglutamstat’s effect on kidney function in two independent randomized double-blind placebo-controlled Phase 2 studies Similarities and differences between VIVIAD & VIVA-MIND Parameter VIVIAD (Europe) VIVA-MIND (U.S.) Patient selection Mild AD, mean age 68 yrs Mild AD, mean
Slide 8: VIVIAD and VIVA-MIND both show significant improvement in eGFR over baseline
VIVIAD and VIVA-MIND both show a statistically significant and clinically meaningful improvement in eGFR over baseline eGFR results (MDRD); all patients randomized to 600 mg BID varoglutamstat (v) and placebo (p) 7 6 eGFR treatment effect: eGFR treatment effect varoglutamstat vs 5 placebo mL/min/1.7
Slide 9: Compelling beneficial effect on kidney function compared to placebo
Compelling beneficial effect on kidney function in subjects treated with varoglutamstat compared to placebo Change in eGFR over time; pooled data from VIVIAD and VIVA-MIND (MMRM); All subjects; 600mg BID varoglutamstat Varoglutamstat ◆ Clear and consistent separation of curves after 24 weeks baselin
Slide 10: Consistent improvement in kidney function across distinct treatment periods
Consistent improvement in kidney function and effect size across distinct treatment periods in both studies Sensitivity analysis; all patients randomized to 600 mg BID varoglutamstat (v) and placebo (p) 7 p=0.003 eGFR treatment effect varoglutamstat vs 6 6.21 eGFR treatment effect: p=0.01 placebo mL
Slide 11: Results nearly identical between studies with or without diabetes
Results are nearly identical between studies when comparing treatment effect in patients with or without diabetes, with consistently higher effect in diabetes Subgroup analysis; with and without diabetes; 600 mg BID varoglutamstat (v) and placebo (p) 10 9 eGFR treatment effect varoglutamstat vs 8 eG
Slide 12: Strong efficacy signal in patients with diabetes at different timepoints
Consistent and very strong efficacy signal and large treatment effect observed in both studies in patients with diabetes at different timepoints Subgroup analysis; patients with diabetes; 600 mg BID varoglutamstat (v) and placebo (p) 10 9 9.41 eGFR treatment effect varoglutamstat vs 8 8.85 eGFR trea
Slide 13: Responder analysis: kidney function improved or stabilized with varoglutamstat
Responder analysis: kidney function predominantly improved or stabilized in varoglutamstat treated patients compared to a decline in the placebo group Diabetes patients pooled VIVIAD & VIVA-MIND 100% % patients with eGFR response of improving, stable 90% 22% Classification of eGFR response 80% 38% (
Slide 14: Sensitivity analysis: responder analysis in diabetes patients
Sensitivity analysis: side by side comparison of responder analysis in diabetes patients shows high consistency between studies in diabetes patients Placebo 600 mg varoglutamstat 100% 100% 90% 90% 18% 29% 80% 80% 9% 70% 70% 67% 60% 80% 60% 50% 50% 40% 40% 73% 71% 30% 8% 30% 20% 20% 25% 10% 20% 10% 0
Slide 15: Meta-analysis shows strong effect on eGFR
VIVIAD and VIVA-MIND: Meta-analysis shows strong effect on eGFR Difference of change from baseline between varoglutamstat (v) and placebo (p) of eGFR (MDRD) ◆ Meta-analysis includes all patients on ∆ = 1.3 mL/min/1.73m2 placebo and all patients randomized to p=0.198 600 mg varoglutamstat BID of both
Slide 16: Meta-analysis shows larger effect size in diabetes versus non-diabetes
VIVIAD and VIVA-MIND: Meta-analysis shows a larger effect size in diabetes versus non-diabetes patients Difference of change from baseline between varoglutamstat (v) and placebo (p) of eGFR (MDRD) ∆ = 1.8 mL/min/1.73m2 ∆ = 1.5 mL/min/1.73m2 p=0.55 p=0.17 ∆ = 7.1 mL/min/1.73m2 ∆ = 4.1 mL/min/1.73m2 p
Slide 17: Safety: pooled analysis shows varoglutamstat is well tolerated
Safety: pooled analysis of VIVIAD and VIVA-MIND 600 mg varoglutamstat is well tolerated All patients randomized to 600 mg varoglutamstat BID and placebo Extensive safety package (# / duration) 90 Pharmacology / Phase 1 80 ◆ Phase 1 study: large trial with 205 % of patients with an event subjects 70
Slide 18: Pooled safety analysis: TEAE by system organ class
Pooled safety analysis VIVIAD and VIVA-MIND: TEAE by system organ class All patients randomized to 600 mg varoglutamstat BID and placebo All events independent of relationship assessment Infections and infestations Gastrointestinal disorders Nervous system disorders Psychiatric disorders Musculoskel
Slide 19: Varoglutamstat reduces pro-inflammatory cytokines pE-CCL2 and pE-CCL13 in plasma
Inhibition of QPCTL by varoglutamstat effectively reduces pro-inflammatory cytokines pE-CCL2 and pE-CCL13 in plasma ◆ Measurement of VIVIAD plasma samples1 using new, highly sensitive, liquid chromatography- mass spectrometry (LC/MS)-based assay revealed a reduction in pE-CCL2 and pE-CCL13 levels ◆
Slide 20: Dose-dependent reduction of pE-CCL2 correlates with improvement of eGFR
Dose-dependent reduction of pE-CCL2 correlates with improvement of eGFR Median reduction in pE-CCL2 levels at week 48 Varoglutamstat effect on kidney function outcomes compared to baseline with varoglutamstat (total population; change in eGFR over time slope analysis (total population) (MDRD)1) 1 Ch
Slide 21: eGFR improvement correlates with pE-CCL2 reduction at patient level
Improvement of eGFR correlates with reduction of pE-CCL2 on individual patient level, in line with total population data Varoglutamstat treatment decreases pE-CCL2 in majority of participants Statistically significant correlation between change in pE-CCL2 serum levels at week 48 and the slope in eGF
Slide 22: New DKD preclinical model results corroborate effects of varoglutamstat
New diabetic kidney disease preclinical model results corroborate effects of varoglutamstat on inflammation, fibrosis and kidney function (% fractional area) Inflammation Kidney CD11c ◆ Evaluated varoglutamstat in an established preclinical model specific for DKD (reninAAV-accelerated DKD model in s
Slide 23: Synergistic effects of dapagliflozin plus varoglutamstat in CKD mouse model
Impressive synergistic effects of dapagliflozin plus varoglutamstat - pronounced modulation of inflammatory and fibrotic mechanisms in CKD mouse model Results pave the development path of QPCT/L inhibitors in combination with SGLT-2 inhibitors Inflammation (CD11c) ◆ Efficacy observed on top of SGLT-
Slide 24: QPCTL inhibitors reduce oxidative stress in Fabry disease kidney cells
QPCTL inhibitors reduce oxidative stress in Fabry disease kidney cells About Fabry disease ◆ Rare genetic disorder affecting more than 1/15,000 people1, resulting from a deficiency of the enzyme alpha-galactosidase A ◆ Leads to accumulation of certain metabolic products inside cells of the kidney (p
Slide 25: Varoglutamstat: Potential to become a convenient new oral therapy
Varoglutamstat: Potential to become a convenient new oral therapy to transform the treatment of kidney disease Medical Need Opportunity Therapies that can stabilize Varoglutamstat is a first-in-class single agent oral compound that has or improve kidney function been shown to stabilize and partially
Slide 26: Effect size substantially higher than current standard of care
Effect size substantially higher than observed with current standard of care (SGLT2i / GLP-1) SGLT2i GLP-1 MRA QPCT/L Delta eGFR slope (mL/min/1.73m2/year) 6 60 Albuminuria reduction (%) 5 50 4 40 3 30 2 20 1 10 0 0 2 3 4 Dapagliflozin 1 Canagliflozin Semaglutide Finerenone Varoglutamstat (diabetes
Slide 27: Varoglutamstat's ability to stabilize and partially recover kidney function sets it apart
Varoglutamstat’s ability to stabilize and partially recover kidney function sets it apart in the kidney space and supports its potential to transform disease outcomes Oral Preserves kidney function improving eGFR New MoA Varoglutamstat Stabilizing or Alpine (acq. Synergistic with SoC Larger
Slide 28: Initial target market represents an attractive patient opportunity
Initial target market represents an attractive patient opportunity with potential label expansion to earlier stages of DKD / CKD ~70-75M3 Diabetes patients US & EU 25-30M4 DKD patients (CKD + Diabetes) 3-6M4 DKD patients Stage 3b/4 Total prevalent population 1International Diabetes Federation (IDF
Slide 29: New Study: Efficient study design in patients with advanced DKD
New Study: Efficient study design to confirm the treatment effect in patients with advanced DKD1 Primary ◆ Aiming to confirm the efficacy of varoglutamstat 600mg BID on eGFR in people with Goal advanced diabetic kidney disease in an efficient and timely manner ◆ Double-blind randomized placebo-contr
Slide 30: Summary: Varoglutamstat in DKD/CKD - building a robust body of evidence
Summary: Varoglutamstat in DKD/CKD - building a robust body of evidence and advancing kidney disease program H1 2025 Building evidence & 2024 Phase 2b DKD preparations 2023 ◆ Compelling kidney function data & meta-analysis from two Ph 2 studies - oral presentation at ERA Data-driven shift to DKD 202
Slide 31: Pipeline focused on kidney disorders and inflammatory/fibrotic diseases
Pipeline focused on kidney disorders and inflammatory/fibrotic diseases Program Approach Discovery Preclinical Phase 1 Phase 2 Phase 3 Status DKD SMI Preparing for Phase 2b DKD study POC in VIVIAD & VIVA-MIND results (Varoglutamstat/PQ912) QPCT/L Inflammatory/fibrosis Kidney orphan diseases SMI Pre-
Slide 32: QPCTL inhibitors have a large market potential
QPCTL inhibitors have a large market potential: Development opportunities across a range of diseases driven by underlying inflammation / fibrosis DKD / CKD / Rare kidney Disorders progressing through earlier stages diseases inflammation & fibrosis Replication of a sustained e.g. Alport / Fabry disea
Slide 33: New development compound VY2149 shows improved cellular uptake and PK profile
New development compound VY2149 shows improved cellular uptake, PK profile and superior outcomes in kidney animal studies Key PK Parameters1 10 9 8 7 ◆ Higher intracellular QPCTL inhibition translates to better 6 activity, lower doses and the opportunity for once daily 5 4 dosing 3 2 ◆ Pre-clinical
Slide 34: A trusted company: Senior management team with a strong track record
A trusted company: Senior management team with a strong track record Management Frank Weber, MD Anne Doering, CFA Michael Schaeffer, PhD Julia Neugebauer, PhD Chief Executive Officer Chief Financial Officer* Chief Business Officer Chief Operating Officer Non-executive Directors Erich Platzer, MD, Ph
Slide 35: Vivoryon: Poised to improve kidney health with varoglutamstat
Vivoryon: Poised to improve kidney health with varoglutamstat’s novel mechanism of action and breakthrough clinical trial results Addressing unmet Unique oral asset with Compelling Phase 2 Actionable, risk- needs in areas of high MOA targeting results replicated in two contained plan for commercial
Slide 36: Vivoryon Therapeutics N.V.
Vivoryon Therapeutics N.V. Halle (Saale) Weinbergweg 22 06120 Halle (Saale), Germany Munich Franz-Josef-Delonge-Str. 5 81249 München, Germany IR@vivoryon.com +49 (0)345 555 99 00 www.vivoryon.com
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