Vivoryon Therapeutics N.v. · EURONEXT:VVY
Vivoryon Therapeutics — Q3 2024 Earnings Presentation
21 slides from Vivoryon Therapeutics's earnings presentation, Dec 10, 2024
Slide 1: Q3 2024: Financial Results & Operational Update
Q3 2024: Financial Results & Operational Update Strong Progress Advancing Varoglutamstat in Kidney Disease December 10, 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: Q3 2024 Key Highlights and Post-period Updates
Q3 2024 Key Highlights and Post-period Updates Reported that VIVA-MIND shows highly significant improvement of eGFR versus placebo, confirming VIVIAD eGFR results Presented kidney outcome results from VIVIAD study in late breaking oral session at ASN Kidney Week, the world’s premiere nephrology meet
Slide 4: Varoglutamstat MOA & Clinical Data
VAROGLUTAMSTAT MOA & CLINICAL DATA
Slide 5: 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 6: VIVA-MIND U.S. study design in early AD
VIVA-MIND U.S. study design in early AD 1:1 randomization Q3 2023: Q2 2024: 109 patients treated DSMB confirmed continuation Decision to discontinue for up to 72 weeks on 600mg BID study early1 Placebo Varoglutamstat 600mg BID Patients2: Objectives: Kidney Function: • Early Alzheimer’s • Assess the
Slide 7: VIVA-MIND Phase 2: Baseline characteristics and disposition
VIVA-MIND Phase 2: Baseline characteristics and disposition VIVA-MIND total population 1 Demographics & baseline characteristics Varoglutamstat N (%) Placebo N (%) Number randomized 53 59 Number of participants (mITT) 52 57 Sex - n (%) Female 24 (46.2) 30 (52.6) Male 28 (53.8) 27 (47.4) Age (in year
Slide 8: VIVA-MIND analysis reveals no consistent effect on pre-specified AD endpoints
VIVA-MIND analysis reveals no consistent effect of varoglutamstat 600mg BID on pre-specified AD endpoints Pre-specified endpoints Status and context ◆ No clinically meaningful and no statistically significant ◆ VIVA-MIND was designed as a stage-gated seamless differences between varoglutamstat 600mg
Slide 9: Favorable safety and tolerability profile with no new safety signals in VIVA-MIND
Varoglutamstat continues to demonstrate a favorable safety and tolerability profile with no new safety signals identified in VIVA-MIND Varoglutamstat Placebo Overall Adverse event category (%) (N=53)* (N=56)* (N=109) any TEAE 84.9 78.6 81.7 any related TEAE 30.2 32.1 31.2 TEAE by severity mild 26.4
Slide 10: Statistically significant improvement vs. placebo in kidney function measured by eGFR
Statistically significant and clinically meaningful improvement vs. placebo in kidney function measured by eGFR (changes from baseline; 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
Slide 11: Sensitivity analysis: MDRD and CKD-EPI show consistent eGFR improvement
Sensitivity analysis: MDRD and CKD-EPI calculations show consistent and comparable statistically significant improvement vs. placebo on eGFR Improvement of eGFR versus placebo Improvement of eGFR versus placebo Calculated using MDRD Calculated using CKD-EPI 5 5 P=0.004a varoglutamstat vs. placebo va
Slide 12: Similarities and differences between VIVA-MIND and VIVIAD studies
Similarities and differences between VIVA-MIND and VIVIAD studies Parameter VIVA-MIND VIVIAD Discontinued early Study completion Completed (no AD efficacy signal in VIVIAD) Patient selection Mild AD, mean age 72 Mild AD, mean age 68 Number of patients treated 109 259 Varoglutamstat dose 600mg BID 30
Slide 13: 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=0.004a P<0.0
Slide 14: Cross study comparison VIVA-MIND and VIVIAD
Cross study comparison VIVA-MIND and VIVIAD eGFR Results – weeks 60 and 72 – Last two visits on treatment VIVA-MIND Improvement of eGFR versus placebo week 60 Improvement of eGFR versus placebo week 72 7 7 P<0.002 varoglutamstat 600mg BID vs. varoglutamstat 600mg BID vs. 6 6 placebo mL/min/1.73m2 pl
Slide 15: Summary of kidney function data from varoglutamstat Phase 2 program
Summary of kidney function data from varoglutamstat Phase 2 program ✓ Two double blind placebo-controlled studies - one conducted in Europe and one in US - showed consistent statistically significant and clinically meaningful improvement of eGFR for varoglutamstat versus placebo ✓ In both studies eG
Slide 16: Financial Results & Outlook
Financial Results & Outlook
Slide 17: Financials reflect prudent spending while refocusing on kidney disease
Financials reflect prudent spending while refocusing on kidney disease In €k Nine months ended Nine months ended Sept. 30, 2024 Sept. 30, 2023 Revenue 0 0 Research & Development expenses (12,582) (10,449) General & Administrative expenses (4,897) (6,803) Net loss for the period (17,143) (17,120) In
Slide 18: Looking ahead: Upcoming value drivers
Looking ahead: Upcoming value drivers 2026+ 2025 2024 MoA/biomarker data Ph. 2 DKD study interim data (~15 months post P2 initiation) VIVIAD data readout ✓ Orphan kidney pre- clinical data Ph. 2 DKD study full data Strategic shift to ✓ (~15 months post P2 interim) kidney disease Start Ph. 2 DKD stud
Slide 19: Phase 2 program confirms varoglutamstat as a leading compound for kidney disorders including DKD
Vivoryon: Phase 2 program confirms varoglutamstat as a leading compound for further development in kidney disorders including DKD Strong scientific base; novel MoA (QPCT/L inhibition); pE-CCL2 data confirms target engagement Two independent studies; compelling long-term kidney function improvement;
Slide 20: Q&A
Q&A
Slide 21: 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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