Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Investor Presentation (January 2025)
24 slides from Vivoryon Therapeutics's investor presentation, January 2025
Slide 1: Improving Kidney Health Outcomes
Improving Kidney Health Outcomes Lead Program: Varoglutamstat in Diabetic Kidney Disease January 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 studies 1; compelling long-term kidney function improveme
Slide 4: Inhibition of QPCTL reduces kidney inflammation and fibrosis, and improves kidney function
Groundbreaking discovery: Inhibition of QPCTL reduces kidney inflammation and fibrosis, and improves kidney function Varoglutamstat substrate protein pyroglutamate inflammatory Pro-inflammatory chemokines QPCTL and fibrotic inhibition leads peptides require to reduction in pyroglutamate QPCTL pE-CCL
Slide 5: Robust research supports development of QPCTL inhibitors in kidney and liver disorders
Robust research supports development of QPCTL inhibitors in inflammatory and fibrotic kidney and liver disorders Pharmacological inhibition of the chemokine Inflammation/kidney disease CCL2 (MCP-1) diminishes liver macrophage publications past 40 years* infiltration and steatohepatitis in chronic he
Slide 6: VIVIAD: Breakthrough clinical results show statistically significant improvement in eGFR
VIVIAD: Breakthrough clinical results show statistically significant improvement in prospectively defined eGFR over two years Validated regulatory primary endpoint All subjects Magnitude of effect of slope analysis Diabetes Change in eGFR over time Change in eGFR over time Slope analysis Slope analy
Slide 7: VIVIAD: Consistency of results using diverse and validated methods for eGFR assessment
VIVIAD: Consistency of results using diverse and validated methods for eGFR assessment Sensitivity analysis: baseline adjusted treatment effect of varoglutamstat versus placebo Method used 2021 CKD-EPI cystatin C 2021 CKD-EPI creatinine * **** 10 9.49 ** *** 10 9 9 varoglutamstat vs. placebo eGFR tr
Slide 8: VIVA-MIND: Significant and clinically meaningful improvement in kidney function
VIVA-MIND: Statistically significant and clinically meaningful improvement vs. placebo in kidney function measured by eGFR (total population; MDRD) Improvement of eGFR versus placebo Improvement of eGFR versus placebo across all timepoints by treatment period 6 6 p<0.01 varoglutamstat vs. placebo p=
Slide 9: eGFR Results Comparison VIVA-MIND – VIVIAD
eGFR Results Comparison VIVA-MIND – VIVIAD VIVA-MIND VIVIAD Varoglutamstat improvement of eGFR Varoglutamstat 600mg BID improvement versus placebo MDRD of eGFR versus placebo MDRD 7 7 varoglutamstat vs. placebo varoglutamstat vs. placebo 6 6 eGFR treatment effect eGFR treatment effect p=0.004 p<0.00
Slide 10: VIVIAD and VIVA-MIND: 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) ∆ = 1.3 mL/min/1.73m2 ◆ Meta-analysis includes all patients on p=0.198 placebo and all patients randomized to 600mg varoglutamstat BID of both
Slide 11: Meta-analysis shows a larger effect size in diabetes versus non-diabetes patients
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 12: VIVIAD: Excellent safety profile consistent across two years
VIVIAD: Excellent safety profile consistent across two years of study duration VIVIAD Phase 2b study % of patients with at least one TEAE1 1 % of patients with at least one Treatment-Emergent Adverse Events (TEAE) in a System Organ Class, lists only occurrence > 5% in the total population; 12 © Vivo
Slide 13: VIVA-MIND: No new safety signals identified in second Phase 2 study
VIVA-MIND: No new safety signals identified in second Phase 2 study VIVA-MIND Phase 2 study Extensive safety package (# / duration) Varoglutamstat Placebo Overall Pharmacology / Phase 1 Adverse event category (%) (n=53)* (n=56)* (n=109) ◆ Phase 1 study: large trial with 205 any TEAE 84.9 78.6 81.7 s
Slide 14: Clear dose-finding results strongly correlated with MoA and biomarker
Clear dose-finding results strongly correlated with MoA and biomarker Reduction of pE-CCL2 in VIVIAD correlates with improvement of eGFR Varoglutamstat effect on kidney function outcomes Median reduction in pE-CCL2 levels at week 48 (total population; change in eGFR over time (MDRD) 1) compared to b
Slide 15: Summary of kidney function data from varoglutamstat Phase 2b program
Summary of kidney function data from varoglutamstat Phase 2b program ✓ Two double blind placebo-controlled studies - one conducted in Europe and one in U.S. - showed consistent statistically significant and clinically meaningful improvement of eGFR for varoglutamstat versus placebo ✓ In both studies
Slide 16: Outstanding commercial potential: Available medicines only slow disease progression 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 17: DKD is the leading cause of end stage kidney disease
DKD1 is the leading cause of end stage kidney disease (ESKD) Inflammation and fibrosis are key underlying pathways in DKD Diabetes is a leading cause of Diabetes is a significant and end-stage kidney disease2 growing global challenge (adults aged 20-79 years with diabetes, worldwide) 3 783M 2045 643
Slide 18: Planned Phase 2b study in stage 3b/4 DKD on top of standard of care
Planned Phase 2b study in stage 3b/4 DKD on top of standard of care 1 Draft study design, with anticipated interim analysis at 15 months after study start Persistent albuminuria categories Enrollment: Description and range Normal to Moderately Severely ◆ Patients: Diabetes patients with CKD 3b/4 eGF
Slide 19: 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 20: A trusted company: Senior management team with a strong track record
A trusted company: Senior management team with a strong track record Executive Directors Frank Weber, MD Anne Doering, CFA Michael Schaeffer, PhD Chief Executive Officer Chief Financial Officer Chief Business Officer Non-executive Directors Erich Platzer, MD, PhD Charlotte Lohmann Claudia Riedl, PhD
Slide 21: Looking ahead: Upcoming value drivers
Looking ahead: Upcoming value drivers 2026+ 2025 2024 MoA/biomarker data Ph. 2b DKD study interim data (~15 months post P2 initiation) VIVIAD data readout ✓ Orphan kidney pre- clinical data Ph. 2b DKD study full data Strategic shift to ✓ (~15 months post P2 interim) kidney disease Start Ph. 2b DKD s
Slide 22: 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 23: Phase 2 program confirms varoglutamstat as a leading compound for kidney disorders
Vivoryon: Phase 2 program confirms varoglutamstat as a leading compound for further development in kidney disorders including DKD Groundbreaking Inhibition of QPCTL reduces kidney inflammation and fibrosis discovery Breakthrough Varoglutamstat – first in class QPCT/L inhibitor – shows a large and st
Slide 24: 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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