Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — H1 2024 Earnings Presentation
26 slides from Vivoryon Therapeutics's earnings presentation, Sep 12, 2024
Slide 1: Half Year 2024: Financial Results & Operational Update
Half Year 2024: Financial Results & Operational Update Progress Marked by Compelling Kidney Function Data and Execution of Strategy to Advance Varoglutamstat in Kidney Disease September 12, 2024 |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: Key highlights
Key highlights Continued strong progress in transitioning strategy driven by compelling kidney function data Rigorous scientific research laid foundation for opportunity in inflammatory/fibrotic diseases A major step forward in kidney disease emerging Deeper understanding of varoglutamstat’s MoA and
Slide 4: H1 2024 was marked by continuous progress and successfully transitioning our strategy
H1 2024 was marked by continuous progress and successfully transitioning our strategy, led by compelling kidney function data Advancing development in DKD and exploring orphan kidney disorders VIVIAD Phase 2 results revealed ◆ Varoglutamstat’s unique product profile could change the exciting kidney
Slide 5: Selectively preventing post-translational modification is key to tackling pathologically altered cellular processes
Selectively preventing post-translational modification is key to tackling pathologically altered cellular processes QPCT ◆ Post-translational modification (PTM) occurs both Map of PTMs that enable specific physiologically and in disease settings, it is a crucial functions QPCTL process to functional
Slide 6: Varoglutamstat is designed to prevent inflammatory and fibrotic processes by blocking pyroglutamate formation
Varoglutamstat is designed to prevent inflammatory and fibrotic processes by blocking pyroglutamate formation on key disease drivers Chronic kidney disease, Inflammatory/fibrotic diseases ◆ Varoglutamstat is a highly potent, oral small molecule inhibitor of human QPCTL which is localized CCL2 intrac
Slide 7: Key pre-clinical findings support development of QPCTL inhibitors in kidney and liver disorders
Key pre-clinical findings support development of QPCTL inhibitors in kidney and liver disorders with high unmet medical need Pharmacological inhibition of the chemokine CCL2 (MCP-1) diminishes liver macrophage infiltration and steatohepatitis in chronic Inflammation/kidney disease hepatic injury pub
Slide 8: Understanding the different outcomes in VIVIAD
Understanding the different outcomes in VIVIAD Conducted stepwise analysis of the VIVIAD results to better understand the difference in outcomes between kidney and AD: 1 Concentration of varoglutamstat in serum and CSF at 300 and 600 mg 2 Inhibition of the extracellular QPCT (QC) enzyme in serum and
Slide 9: Concentration of varoglutamstat in serum and CSF at week 8
1 Concentration of varoglutamstat in serum and CSF at week 48 Geometric mean concentration of free varoglutamstat between 2-6h post dosing ng/ml Key conclusions 350 ◆ The blood brain barrier reduces the 300 concentration of varoglutamstat in the 250 CSF compared to serum 200 ◆ Dose-dependent concent
Slide 10: Inhibition of the extracellular QPCT (QC) enzyme in serum and CSF
2 Inhibition of the extracellular QPCT (QC) enzyme in serum and CSF: measurement of QPCT activity / calculation of target inhibition Target inhibition by varoglutamstat: QPCT enzyme in the serum / CSF Key conclusion 100 90 ◆ Strong and significant 80 % enzyme inhibition inhibition of the extracellul
Slide 11: Inhibition of intracellular QPCTL measured by reduction of pE-CCL2 at week 48
3 Inhibition of the intracellular QPCTL (iso-QC) enzyme measured by reduction of pE-CCL2 formation at week 48 Key conclusions Reduction of pE-CCL2 from baseline ◆ Strong inhibition of the intracellular Serum 600mg Serum 300mg CSF 600mg CSF 300mg QPCTL at 600mg BID varoglutamstat 0 demonstrated by st
Slide 12: Reduction of pE-Abeta-40 in the CSF (target peptide for AD - initial results)
4 Reduction of pE-Abeta-40 in the CSF (target peptide for AD - initial results) Change in pE-Abeta-40 and pE-CCL2 Key conclusions from baseline pE-Abeta CSF 600mg pE-CCL2 CSF 600mg ◆ A 13% reduction of pE-Abeta in the CSF was 0 observed in a first set of samples (n=36) at a -5 dose of 600mg BID % re
Slide 13: Intracellular inhibition of pE peptides is the key driver for efficacy
Intracellular inhibition of pE peptides is the key driver for efficacy Varoglutamstat effect on kidney function outcomes Varoglutamstat effect on AD outcomes Change in eGFR over time (measured using MDRD)1 Change in complete Cogstate NTB score over time2 Z-score High varoglutamstat concentrations le
Slide 14: Results provide deeper understanding of VIVIAD data and confirm QPCTL is an attractive target in kidney disease
Results provide deeper understanding of VIVIAD data and confirm QPCTL is an attractive target in kidney disease The VIVIAD study provides clear evidence: ◆ Concentration profiles of varoglutamstat intensively studied in Phase 1 were confirmed in VIVIAD (PK) ◆ Varoglutamstat strongly inhibits extrace
Slide 15: Comprehensive body of evidence underpins strategic shift
Comprehensive body of evidence underpins strategic shift VIVIAD Phase 2b kidney data highlights (all patients): ◆ Robust effects on eGFR independent of analytical method, formula for calculations and substrate either creatinine or cystatin C in the total population of VIVIAD ◆ Persistency of effect
Slide 16: Kidney function effects are consistent and robust across various validated analysis methods
Kidney function effects are consistent and robust across various validated analysis 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- 2021 CKD-EPI creatinine MDRD cystatin
Slide 17: Effect size more than doubled in diabetes subgroup
Effect size more than doubled in diabetes subgroup eGFR measured using creatinine and MDRD All subjects (n=258) Diabetes (n=32) Treatment effect in diabetes subgroup1 was substantially Placebo n= 117 Varo n=141 Placebo n=12 Varo n=20 higher than in the overall patient population 9 ◆ Improvement of
Slide 18: Targeting inflammation offers a third complementary element to existing therapeutic approaches for DKD
Targeting inflammation offers a third complementary element to existing therapeutic approaches for DKD ◆ Activation of pro-inflammatory proteins and pathways is a hallmark of DKD pathogenesis1 ◆ Varoglutamstat directly attenuates pro-inflammatory Metabolism Hypertension signaling by destabilizing ke
Slide 19: Planning to conduct a Phase 2 study in advanced stage 3b/4 diabetic kidney disease
Planning to conduct a Phase 2 study in advanced stage 3b/4 diabetic kidney disease (DKD) on top of standard of care (SoC)1 Expected to meet industry needs and address key questions, interim analysis at month 15 Draft design ◆ Stage 3b/4 DKD patients with > 100mg/g albuminuria / Key endpoints protein
Slide 20: Varoglutamstat: a unique target product profile in DKD
Varoglutamstat: a unique target product profile in DKD with the potential to improve kidney outcomes Efficacy Safety & Administration Kidney function improvement: ◆ Excellent tolerability and safety profile ◆ Robust effect with clear improvement of eGFR over ◆ No worsening of proteinuria (potential
Slide 21: Financial Results & Outlook
FINANCIAL RESULTS & OUTLOOK
Slide 22: Financials reflect prudent spending while refocusing on kidney disease
Financials reflect prudent spending while refocusing on kidney disease In €k Jun 30, 2024 Jun 30, 2023 Revenue 0 0 Research & Development expenses (10,308) (6,259) General & Administrative expenses (3,501) (4,433) Net loss for the period (13,559) (10,761) In €k Jun 30, 2024 Dec 31, 2023 Cash & cash
Slide 23: Vivoryon: Mid-stage clinical biotech company with first-in-class QPCT/L inhibitor
Vivoryon: Mid-stage clinical biotech company with first-in-class QPCT/L inhibitor targeting high unmet need in kidney disease Compelling efficacy and safety data in people at risk of kidney disease ✓ Statistically significant effect on kidney function in total VIVIAD population and diabetes subgroup
Slide 24: Virtual Kidney Disease KOL Event
Up next: External views on varoglutamstat and opportunities in kidney disease Virtual Kidney Disease KOL Event Monday, September 30, 2024 at 3:00pm CEST (9:00am EDT) ◆ Expert presentations by seasoned KOLs followed by Q&A session ◆ Standard of care and existing medical need in kidney disease ◆ Marke
Slide 25: Q&A
Q&A
Slide 26: 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 Info@vivoryon.com +49 (0)345 555 99 00 www.vivoryon.com
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