Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Investor Presentation (May 2025)
29 slides from Vivoryon Therapeutics's investor presentation, May 2025
Slide 1: Improving Kidney Health Outcomes
Improving Kidney Health Outcomes Lead Program: Varoglutamstat in Diabetic Kidney Disease May 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: Poised to improve kidney health with varoglutamstat's novel mechanism of action
Vivoryon: Poised to improve kidney health with varoglutamstat’s novel mechanism of action and breakthrough clinical results Strong scientific base; novel MoA (QPCT/L inhibition); pE-CCL2 data confirms target engagement Two independent Phase 2 studies1; compelling long-term kidney function improvemen
Slide 4: Inhibiting QPCTL has potential to halt 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: Inhibition of QPCT/L reduces kidney inflammation and fibrosis
Groundbreaking discovery: Inhibition of QPCT/L reduces kidney inflammation and fibrosis, and improves pathophysiology and kidney function improved kidney QPCT/L inhibition leads to activity modulation of Varoglutamstat inflammatory and impaired kidney fibrotic peptides QPCT/L substrate protein Kidne
Slide 6: 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 7: VIVIAD and VIVA-MIND show significant improvement in eGFR
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 8: Consistent improvement in kidney function across 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 9: Treatment effect in patients 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 10: Strong efficacy signal in patients with diabetes
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 11: Responder analysis of eGFR in diabetes patients
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 12: Sensitivity analysis of 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 13: 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 14: Meta-analysis shows larger effect 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 15: Safety: pooled analysis of VIVIAD and VIVA-MIND
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 16: 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 17: Inhibition of QPCTL decreases pro-inflammatory cytokines and kidney fibrosis
Robust evidence demonstrating inhibition of intracellular QPCTL decreases activity of pro-inflammatory cytokines and kidney fibrosis 50 40 25 20 0 0 Kidney Col III Kidney α-SMA (% fractional area) (% fractional area) Decrease of pE-CCL2 levels by QPCT/L Histological changes show improvement Median r
Slide 18: A convenient new treatment option to fill the gap in kidney diseases
A convenient new treatment option to fill the existing gap in kidney diseases Varoglutamstat has the potential to stabilize/counteract continuous decline in kidney function Single agent oral compound First-in-class mechanism of action addressing key pathways in inflammation / fibrosis Consistent, st
Slide 19: Outstanding commercial potential versus available medicines in DKD
Outstanding commercial potential: Currently available, highly successful medicines only slow disease progression in DKD SGLTi eGFR (compiled)4 SGLT2 GLP-1 QPCT/L Drug / Trial name Canagliflozin Dapagliflozin Semaglutide Varoglutamstat CREDENCE1 DAPA-CKD2 FLOW3 VIVIAD Diabetes subgroup Annualized eGF
Slide 20: Varoglutamstat is well-positioned in competitive landscape
Vivoryon’s varoglutamstat is well-positioned in competitive landscape Stabilizing or improving eGFR Varoglutamstat Key characteristics Varoglutamstat oral ProKidney REACT Autologous Cell Therapy oral Ph2 Ph3 Slowed/continued Novel MoA decline of eGFR or no eGFR data Palatin First-in-class QPCTLi Bre
Slide 21: Initial target market and potential label expansion
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 22: Phase 2 evidence supports move into Phase 2b study
Robust Phase 2 evidence supports move into Phase 2b study in target population 1 Primary ◆ Confirm the efficacy of varoglutamstat 600mg BID on eGFR in people with advanced Goal diabetic kidney disease in an efficient and timely manner ◆ Double-blind randomized placebo-controlled multi-center study ◆
Slide 23: 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 24: QPCTL inhibitors have large market potential across diseases
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 25: VY2149 shows improved uptake, PK profile and kidney animal results
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 26: A history of groundbreaking discoveries and developments
Vivoryon: A history of groundbreaking discoveries and developments Seminal R&D in diabetes & development of new class SAPHIR Phase 2a VIVIAD & VIVA-MIND of oral antidiabetic agents, the study data with Phase 2 results DPP-4 inhibitors (gliptins) varoglutamstat in AD Introduced reveal exciting kidney
Slide 27: 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, PhD
Slide 28: Poised to improve kidney health with novel mechanism and clinical results
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 29: 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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